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Tumor-Treating Fields at EMBC 2019: A Roadmap to Developing a Framework for TTFields Dosimetry and Treatment Planning

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 3-17

Tumor Treating Fields (TTFields) are electric fields known to exert an anti-mitotic effect on cancerous tumors. TTFields have been approved for the treatment of glioblastoma and malignant pleural mesothelioma. Recent studies have shown a correlation between TTFields doses delivered to the tumor bed and patient survival. These findings suggest that patient outcome could be significantly improved with rigorous treatment planning, in which numerical simulations are used to plan treatment in order to optimize delivery of TTFields to the tumor bed. Performing such adaptive planning in a practical and meaningful manner requires a rigorous and scientifically proven framework defining TTFields dose and showing how dose distribution influences disease progression in different malignancies (TTFields dosimetry). At EMBC 2019, several talks discussing key components related to TTFields dosimetry and treatment planning were presented. Here we provide a short overview of this work and discuss how it sets the foundations for the emerging field of TTFields dosimetry and treatment planning.

*32966033*
 32966033

Example of Steady-State Electric-Current Modeling of a Complicated Cellular Topology with Boundary Element Fast Multipole Method

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 391-396

In this study, we demonstrate the ability of the boundary element fast multipole method (BEM-FMM) to perform electrical modeling of a rather complicated microbiological surface topology in a reasonable amount of time. As an example, we consider a Computer Aided Design (CAD)-based SARS-CoV-2 spike glycoprotein structure. This structure is crucial to the mechanism by which the coronavirus attaches to a target object. Only classic DC steady-state modeling has been performed, in an isotropic continuous medium.

*32966032*
 32966032

Improving Tumor-Treating Fields with Skull Remodeling Surgery, Surgery Planning, and Treatment Evaluation with Finite Element Methods

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 63-77

Tumor-treating fields (TTFields) are alternating fields (200 kHz) used to treat glioblastoma (GBM), which is one of the deadliest cancer diseases of all. Glioblastoma is a type of malignant brain cancer, which causes significant neurological deterioration and reduced quality of life, and for which there is currently no curative treatment. TTFields were recently introduced as a novel treatment modality in addition to surgery, radiation therapy, and chemotherapy. The fields are induced noninvasively using two pairs of electrode arrays placed on the scalp. Due to low electrical conductivity, significant currents are shielded from the intracranial space, potentially compromising treatment efficacy. Recently, skull remodeling surgery (SR-surgery) was proposed to address this issue. SR-surgery comprises the formation of skull defects or thinning of the skull over the tumor to redirect currents toward the pathology and focally enhance the field intensity. Safety and feasibility of this concept were validated in a clinical phase 1 trial (OptimalTTF-1), which also indicated promising survival benefits. This chapter describes the FE methods used in the OptimalTTF-1 trial to plan SR-surgery and assess treatment efficacy. We will not present detailed modeling results from the trial but rather general concepts of model development and field calculations. Readers are kindly referred to Wenger et al. [1] for a more general overview of the clinical implications and applications of TTFields modeling.

*32966031*
 32966031

A Thermal Study of Tumor-Treating Fields for Glioblastoma Therapy

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 37-62

Tumor-treating fields (TTFields) is an antimitotic cancer treatment technique used for glioblastoma multiforme (GBM) and malignant pleural mesothelioma. Although the frequency used is not as high as in hyperthermia, temperature increases due to the Joule effect might be meaningful given the necessary time that these fields should be applied for. Post hoc analysis of the EF-11 clinical trial showed higher median overall survival in patients whose compliance was at least 18 h per day. To quantify these temperature increases and predict the thermal impact of TTFields delivery to the head, we used a realistic model created from MR images segmented in five tissues: scalp, skull, CSF, gray matter (GM), and white matter (WM). Through COMSOL Multiphysics, we solved Laplace's equation for the electric field and Pennes' equation for the temperature distribution. To mimic the therapy as realistically as possible, we also considered complete current shutdown whenever any transducer reached 41 degrees C to allow transducers and tissues' temperature to decrease. Our results indicate an intermittent operation of Optune due to this necessary current shutdown. Localized temperature increases were seen, especially underneath the regions where the transducers were placed. Maximum temperature values were around 41.5 degrees C on the scalp and 38 degrees C on the brain. According to the literature, significant thermal impact is only predicted for the brain where the rise in temperature may lead to an increased BBB permeability and variation in the blood flow and neurotransmitter concentration. Additionally, our results showed that if the injected current is reduced by around 25% compared to Optune's standard way of operating, then uninterrupted treatment might be attainable. These predictions might be used to improve TTFields delivery in real patients and to increase awareness regarding possible thermal effects not yet reported elsewhere.

*32966030*
 32966030

How Do Tumor-Treating Fields Work?

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 19-35

Since approved by the FDA for the treatment of glioblastoma brain cancer in 2015, tumor-treating fields (TTFields) have rapidly become the fourth modality to treat cancer, along with surgery, chemotherapy, and radiation [1]. TTFields are now in clinical trials for a variety of cancer types. While efficacy has been proven in the clinic, the higher efficacy is demonstrated in vitro and in animal models, which indicates much greater clinical efficacy is possible. To attain the great promise of TTFields, uncovering the mechanisms of action (MoA) is necessary.

*32966029*
 32966029

Analytical Solution for the Electric Field Response Generated by a Nonconducting Ellipsoid (Prolate Spheroid) in a Conducting Fluid Subject to an External Electric Field

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 383-389

An analytical solution is presented for the electric field response generated by a nonconducting ellipsoid (prolate spheroid) in a homogeneous conducting fluid subject to an external primary electric field, including surface charge distribution. Such a solution might be useful for different purposes, including cell modeling subject to an external quasistatic electromagnetic stimulus. The solution utilizes the well-known analogy between the electrostatics of dielectrics and DC conduction. The solution obtained includes an expression for the volumetric fields and an expression for the induced surface charge density at the membrane.

*32966028*
 32966028

Estimating Electric Field and SAR in Tissue in the Proximity of RF Coils

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 293-307

Medical implants that require recharging typically use magnetic resonant coupling of transmit (external) and receive (internal) RF coils. Apart from magnetic field, the transmit coil creates a time-varying electric field that excites currents not only in the receive coil but also in the surrounding tissues. Radio frequency (RF) exposure assessment for inductive systems used in wireless powering and telemetry is done using electric field, specific absorption rate (SAR), and induced current as metrics. Full-wave analysis using RF simulation tools such as Ansys HFSS is generally used to estimate these metrics, and the results are widely accepted. However, such simulation-based analysis is quite rigorous and time-consuming, let alone the complexities with setting up the simulation. In this paper, we present a simple approach to estimating exposure (electric field, SAR, induced current) from fundamental electromagnetic principles enabling ability to arrive at results quickly. It significantly reduces the computational time in iterative approaches where multiple simulation runs are needed.

*32966027*
 32966027

A Computational Parcellated Brain Model for Electric Field Analysis in Transcranial Direct Current Stimulation

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 81-99

Recent years have seen the use of increasingly realistic electric field (EF) models to further our knowledge of the bioelectric basis of noninvasive brain techniques such as transcranial direct current stimulation (tDCS). Such models predict a poor spatial resolution of tDCS, showing a non-focal EF distribution with similar or even higher magnitude values far from the presumed targeted regions, thus bringing into doubt the classical criteria for electrode positioning. In addition to magnitude, the orientation of the EF over selected neural targets is thought to play a key role in the neuromodulation response. This chapter offers a summary of recent works which have studied the effect of simulated EF magnitude and orientation in tDCS, as well as providing new results derived from an anatomically representative parcellated brain model based on finite element method (FEM). The results include estimates of mean and peak tangential and normal EF values over different cortical regions and for various electrode montages typically used in clinical applications.

*32966026*
 32966026

Functional Requirements of Small- and Large-Scale Neural Circuitry Connectome Models

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 249-260

We have truly entered the Age of the Connectome due to a confluence of advanced imaging tools, methods such as the flavors of functional connectivity analysis and inter-species connectivity comparisons, and computational power to simulate neural circuitry. The interest in connectomes is reflected in the exponentially rising number of articles on the subject. What are our goals? What are the "functional requirements" of connectome modelers? We give a perspective on these questions from our group whose focus is modeling neurological disorders, such as neuropathic back pain, epilepsy, Parkinson's disease, and age-related cognitive decline, and treating them with neuromodulation.

*32966025*
 32966025

Simplifying the Numerical Human Model with k-means Clustering Method

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 261-270

Currently, the safety assessment of radio-frequency (RF) heating using computational modeling is limited by the available numerical models which are not patient specific. However, RF-induced heating depends on the physical characteristics of the patient. The numerical model generation is difficult due to the highly time-consuming segmentation process. Therefore, having fewer types of segmented structures simplifies the generation of numerical models and reduces computational burden as a result. In this study, we used the k-means clustering method to reduce the number of dielectric properties of an existing numerical model and investigated the resulting difference in specific absorption rate (SAR) with respect to the number of clusters.

*32966024*
 32966024

Modelling Studies of Non-invasive Electric and Magnetic Stimulation of the Spinal Cord

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 139-165

Experimental studies on transcutaneous spinal cord direct current and magnetic stimulation (tsDCS and tsMS, respectively) show promising results in the neuromodulation of spinal sensory and motor pathways, with possible clinical application in spinal functional rehabilitation. Modelling studies on the electric field (EF) distribution during tsDCS and tsMS can be powerful tools to understand the underlying biophysics and to guide stimulation protocols for a specific clinical target. In this chapter, we review modelling studies of tsDCS and report on our own modelling findings on tsDCS and tsMS. We discuss the main differences between the EF induced by these two stimulation techniques and the implications for clinical practice, addressing the relevance of modelling studies for more personalized target protocols and individualized dosing.

*32966023*
 32966023

Personalization of Multi-electrode Setups in tCS/tES: Methods and Advantages

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 119-135

Transcranial current stimulation (tCS or tES) protocols yield results that are highly variable across individuals. Part of this variability results from differences in the electric field (E-field) induced in subjects' brains during stimulation. The E-field determines how neurons respond to stimulation, and it can be used as a proxy for predicting the concurrent effects of stimulation, like changes in cortical excitability, and, ultimately, its plastic effects. While the use of multichannel systems with small electrodes has provided a more precise tool for delivering tCS, individually variable anatomical parameters like the shape and thickness of tissues affect the E-field distribution for a specific electrode montage. Therefore, using the same montage parameters across subjects does not lead to the homogeneity of E-field amplitude over the desired targets. Here we describe a pipeline that leverages individualized head models combined with montage optimization algorithms to reduce the variability of the E-field distributions over subjects in tCS. We will describe the different steps of the pipeline - namely, MRI segmentation and head model creation, target specification, and montage optimization - and discuss their main advantages and limitations.

*32966022*
 32966022

RF-Induced Unintended Stimulation for Implantable Medical Devices in MRI

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 283-292

Historically, patients with implantable medical devices have been denied access to magnetic resonance imaging (MRI) due to several potentially hazardous interactions. There has been significant interest in recent years to provide access to MRI to patients with implantable medical devices, as it is the preferred imaging modality for soft tissue imaging. Among the potential hazards of MRI for patients with an active implantable medical device is radio frequency (RF)-induced unintended stimulation. RF energy incident on the device may be rectified by internal active components. Any rectified waveform present at the lead electrodes may stimulate nearby tissue. In order to assess the risk to the patient, device manufacturers use computational human models (CHMs) to quantify the incident RF on the device and perform in vitro testing to determine the likelihood of unintended stimulation. The use of CHMs enables the investigation of millions of scenarios of scan parameters, patient sizes and anatomies, and MR system technologies.

*32966021*
 32966021

Combining Noninvasive Electromagnetic and Hemodynamic Measures of Human Brain Activity

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 179-193

Magnetoencephalography (MEG) is directly sensitive to postsynaptic neuronal activity with the millisecond temporal resolution. MEG is ideally to complement functional MRI (fMRI), which measures hemodynamic responses secondary to neuronal activity with the millimeter spatial resolution, for noninvasive imaging of human brain function. Here, using the Minimum-Norm Estimate as an example, we review how fMRI can be integrated with MEG (and electroencephalography, EEG) source modeling and summarize potential advantages and pitfalls of this data fusion technique. Neurovascular coupling as the physiological basis for MEG/EEG/fMRI integration is also discussed. Ultimately, we expect to develop multimodal MEG/EEG/fMRI neuroimaging methodology for characterizing spatiotemporal functional connectivity in large-scale neural networks of the human brain with high sensitivity and accuracy.

*32966020*
 32966020

Robustness in Neural Circuits

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 213-229

Complex systems are found everywhere - from scheduling to traffic, food to climate, economics to ecology, the brain, and the universe. Complex systems typically have many elements, many modes of interconnectedness of those elements, and often exhibit sensitivity to initial conditions. Complex systems by their nature are generally unpredictable and can be highly unstable.

*32966019*
 32966019

Using Anatomical Human Body Model for FEM SAR Simulation of a 3T MRI System

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 273-281

Specific absorption rate (SAR) is calculated according to the upcoming IEC/IEEE 62704-4 Standard for Determining the Peak Spatial-Average SAR in the Human Body from Wireless Communications Devices, 30 MHz-6 GHz: General Requirements for Using the Finite Element Method on a tetrahedral mesh and compared to results with the finite integration technique on the hexahedral mesh according to IEC/IEEE 62704-1. The Female Visible Human body model Nelly is applied in a generic magnetic resonance imaging (MRI) coil tuned for a 3 Tesla MRI system. Accuracy and computational effort are compared.

*32966018*
 32966018

Computational Models of Brain Stimulation with Tractography Analysis

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 101-117

Computational human head models have been used in studies of brain stimulation. These models have been able to provide useful information that can't be acquired or difficult to acquire from experimental or imaging studies. However, most of these models are purely volume conductor models that overlooked the electric excitability of axons in the white matter of the brain. We hereby combined a finite element (FE) model of electroconvulsive therapy (ECT) with a whole-brain tractography analysis as well as the cable theory of neuronal excitation. We have reconstructed a whole-brain tractogram with 2000 neural fibres from diffusion-weighted magnetic resonance scans and extracted the information on electrical potential from the FE ECT model of the same head. Two different electrode placements and three different white matter conductivity settings were simulated and compared. We calculated the electric field and second spatial derivatives of the electrical potential along the fibre direction, which describes the activating function for homogenous axons, and investigated sensitive regions of white matter activation. Models with anisotropic white matter conductivity yielded the most distinctive electric field and activating function distribution. Activation was most likely to appear in regions between the electrodes where the electric potential gradient is most pronounced.

*32966017*
 32966017

Preprocessing General Head Models for BEM-FMM Modeling Pertinent to Brain Stimulation

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 325-343

Introduction: Transcranial magnetic stimulation (TMS) is a major noninvasive neurostimulation method in which a coil placed near the head employs electromagnetic induction to produce electric fields and currents within the brain. To predict the actual site of stimulation, numerical simulation of the electric fields within the head using high-resolution subject-specific head models is required. A TMS modeling software toolkit has been developed based on the boundary element fast multipole method (BEM-FMM), which has several advantages over conventional finite element method (FEM) solvers. Objective: To extend the applicability of the BEM-FMM TMS simulation toolkit to head models whose meshing scheme produces a single mesh for every unique tissue instead of producing a single mesh for every unique tissue/tissue boundary. Method: The MIDA model of the IT'IS Foundation, Switzerland, comprises 115 high-resolution tissue models in the form that the BEM-FMM toolkit is modified to accept. The updated BEM-FMM toolkit is tested using this head model. Results: The BEM-FMM toolkit has been successfully modified to accept head models consisting of one unique mesh per unique tissue while still supporting its initial model format of one unique mesh per boundary between two specific tissues. Performance impacts occur in the preprocessing phase only, meaning that the charge computation method performs equally well regardless of model format.

*32966016*
 32966016

A Miniaturized Ultra-Focal Magnetic Stimulator and Its Preliminary Application to the Peripheral Nervous System

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 167-176

Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technique used in the clinic to treat several neurological disorders and psychiatric diseases. One of TMS's significant limitations is its low spatial resolution, which often results in a mismatch between the target area in the brain and the stimulation site on the scalp. To enhance its spatial resolution, we designed and built a complete stimulation system complete with a millimetric-diameter coil and microscopic traces (muCoil). The first tests conducted on healthy volunteers showed that the muCoil stimulation of the radial nerve in the wrist could indeed evoke somatosensory nerve action potentials (SNAPs). In this chapter, we study this nerve stimulation system with electromagnetic and neuron simulators on a neurofunctionalized model from the Virtual Population (ViP v.4) and a muCoil figure-8 geometry. In particular, we study how changes in the muCoil geometry, such as the number of layers, shape, and length of an iron or air core, may help to promote the generation of somatosensory nerve action potentials.

*32966015*
 32966015

The CAD-Compatible VHP-Male Computational Phantom

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 309-323

Anatomically accurate and numerically efficient computational phantoms of humans are essential to characterizing the response of a body to a variety of electromagnetic, acoustic and other types of external stimuli. In conjunction with advances in numerical simulation techniques and computational hardware, these computational phantoms enable exploration of innovative and exciting applications, from medical diagnostic techniques and therapeutic treatments to new ways of on- and in-body communications. However, in order to provide realistic estimates through simulation, the model must represent the subject as closely as possible, necessitating that all relevant anatomical features are captured. If this is not accomplished, the model will misrepresent the true physical environment, and critical information will not be captured during the simulation. This work presents a model of a male subject based on the Visible Human Project dataset. Each component of the model is constructed of triangular surface elements, making it compatible with CAD packages and facilitating its use in simulations based on major numerical methodologies. A description of the model, the procedure used for its construction and a baseline simulation are presented together with future integration and augmentation ideas.

*32966014*
 32966014

Profiling General-Purpose Fast Multipole Method (FMM) Using Human Head Topology

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 347-381

In this study, we characterize the performance of the fast multipole method (FMM) in solving the Laplace and Helmholtz equations. We use the FMM library developed by the group of Dr. L. Greengard. This version of the FMM algorithm is multilayer with no priori limit on the number of levels of the FMM tree, although, after about thirty levels, there may be floating point issues. A collection of high-resolution human head models is used as test objects. We perform a detailed analysis of the runtime and memory consumption of the FMM in a wide range of frequencies, problem sizes, and precisions required. Although we focus on two-manifold test cases, the results are generalizable to other topologies as well. The tests are conducted on both Windows and Linux platforms. The results obtained in this study can serve as a general benchmark for the performance of FMM. It can also be employed to pre-estimate the efficiency of numerical modeling methods (e.g., the boundary element method) accelerated by FMM.

*32966013*
 32966013

Insights from Computational Modelling: Selective Stimulation of Retinal Ganglion Cells

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 233-247

Improvements to the efficacy of retinal neuroprostheses can be achieved by developing more sophisticated neural stimulation strategies to enable selective or differential activation of specific retinal ganglion cells (RGCs). Recent retinal studies have demonstrated the ability to differentially recruit ON and OFF RGCs - the two major information pathways of the retina - using high-frequency electrical stimulation (HFS). However, there remain many unknowns, since this is a relatively unexplored field. For example, can we achieve ON/OFF selectivity over a wide range of stimulus frequencies and amplitudes? Furthermore, existing demonstrations of HFS efficacy in retinal prostheses have been based on epiretinal placement of electrodes. Other clinically popular techniques include subretinal or suprachoroidal placement, where electrodes are located at the photoreceptor layer or in the suprachoroidal space, respectively, and these locations are quite distant from the RGC layer. Would HFS-based differential activation work from these locations? In this chapter, we conducted in silico investigations to explore the generalizability of HFS to differentially active ON and OFF RGCs. Computational models are particularly well suited for these investigations. The electric field can be accurately described by mathematical formulations, and simulated neurons can be "probed" at resolutions well beyond those achievable by today's state-of-the-art experimental techniques.

*32966012*
 32966012

Multiscale Modeling of EEG/MEG Response of a Compact Cluster of Tightly Spaced Pyramidal Neocortical Neurons

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; (): 195-211

In this study, the boundary element fast multipole method or BEM-FMM is applied to model compact clusters of tightly spaced pyramidal neocortical neurons firing simultaneously and coupled with a high-resolution macroscopic head model. The algorithm is capable of processing a very large number of surface-based unknowns along with a virtually unlimited number of elementary microscopic current dipole sources distributed within the neuronal arbor. The realistic cluster size may be as large as 10,000 individual neurons, while the overall computation times do not exceed several minutes on a standard server. Using this approach, we attempt to establish how well the conventional lumped-dipole model used in electroencephalography/magnetoencephalography (EEG/MEG) analysis approximates a compact cluster of realistic neurons situated either in a gyrus (EEG response dominance) or in a sulcus (MEG response dominance).

*32966011*
 32966011

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting

Brain and Human Body Modeling 2020: Computational Human Models Presented at EMBC 2019 and the BRAIN Initiative(R) 2019 Meeting-/- 2021; ():

*32965806*
 32965806

Understanding and Responding to Global Health Security Risks from Microbial Threats in the Arctic: Proceedings of a Workshop

Understanding and Responding to Global Health Security Risks from Microbial Threats in the Arctic: Proceedings of a Workshop-/- 2020; ():

The National Academies of Sciences, Engineering, and Medicine in collaboration with the InterAcademy Partnership and the European Academies Science Advisory Committee held a workshop in November 2019 to bring together researchers and public health officials from different countries and across several relevant disciplines to explore what is known, and what critical knowledge gaps remain, regarding existing and possible future risks of harmful infectious agents emerging from thawing permafrost and melting ice in the Arctic region. The workshop examined case studies such as the specific case of Arctic region anthrax outbreaks, as a known, observed risk as well as other types of human and animal microbial health risks that have been discovered in snow, ice, or permafrost environments, or that could conceivably exist. The workshop primarily addressed two sources of emerging infectious diseases in the arctic: (1) new diseases likely to emerge in the Arctic as a result of climate change (such as vector-borne diseases) and (2) ancient and endemic diseases likely to emerge in the Arctic specifically as a result of permafrost thaw. Participants also considered key research that could advance knowledge including critical tools for improving observations, and surveillance to advance understanding of these risks, and to facilitate and implement effective early warning systems. Lessons learned from efforts to address emerging or re-emerging microbial threats elsewhere in the world were also discussed. This publication summarizes the presentation and discussion of the workshop.

*33030850*
 33030850

The Inclusion of Women in STEM in Kuwait and the United States: Proceedings of a Workshop

The Inclusion of Women in STEM in Kuwait and the United States: Proceedings of a Workshop-/- 2020; ():

Women in the United States and Kuwait have made advances as researchers and leaders in science, engineering, and medical disciplines, yet challenges and barriers remain to enter and advance in these fields in both countries. Building on recent collaborations, the National Academies of Sciences, Engineering, and Medicine and the Kuwait Foundation for the Advancement of Sciences agreed on convening two workshops to identify evidence-based practices and resources for improving the inclusion of women as full participants in science, technology, engineering, and mathematics.This publication summarizes the presentations and discussion from the first workshop, held October 28-29, 2019, in Washington, D.C.

*33026760*
 33026760

Heritable Human Genome Editing

Heritable Human Genome Editing-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing. From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.

*32897669*
 32897669

Mobile Technology for Adaptive Aging: Proceedings of a Workshop

Mobile Technology for Adaptive Aging: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

To explore how mobile technology can be employed to enhance the lives of older adults, the Board on Behavioral, Cognitive, and Sensory Sciences of the National Academies of Sciences, Engineering, and Medicine commissioned 6 papers, which were presented at a workshop held on December 11 and 12, 2019. These papers review research on mobile technologies and aging, and highlight promising avenues for further research.

*32997465*
 32997465

Developing Health Literacy Skills in Children and Youth: Proceedings of a Workshop

Developing Health Literacy Skills in Children and Youth: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Young people develop health literacy skills in a variety of environments, facing critical thinking challenges about their health from school, home and family life, peers and social life, and online. To explore the development of health literacy skills in youth, the Roundtable on Health Literacy convened a workshop on November 19, 2019, in Washington, DC. Presenters at the workshop discussed factors relating to health literacy skills and ways to further develop those skills among youth from early childhood to young adulthood. This publication summarizes the presentation and discussion of the workshop.

*33026761*
 33026761

Low back pain and sciatica in over 16s: assessment and management

Low back pain and sciatica in over 16s: assessment and management-/-National Institute for Health and Care Excellence: Clinical Guidelines 2020; ():

This guideline covers assessing and managing low back pain and sciatica in people aged 16 and over. It outlines physical, psychological, pharmacological and surgical treatments to help people manage their low back pain and sciatica in their daily life. The guideline aims to improve people's quality of life by promoting the most effective forms of care for low back pain and sciatica. The recommendations in this guideline were developed before the COVID-19 pandemic. For advice on neuropathic pain not related to sciatica, see the NICE guideline on neuropathic pain in adults.WHO IS IT FOR? Healthcare professionals. Commissioners and providers of healthcare. People with low back pain or sciatica, and their families and carers.

*33090750*
 33090750

Neuropathic pain in adults: pharmacological management in non-specialist settings

Neuropathic pain in adults: pharmacological management in non-specialist settings-/-National Institute for Health and Care Excellence: Clinical Guidelines 2020; ():

This guideline covers managing neuropathic pain (nerve pain) with pharmacological treatments (drugs) in adults in non-specialist settings. It aims to improve quality of life for people with conditions such as neuralgia, shingles and diabetic neuropathy by reducing pain and promoting increased participation in all aspects of daily living. The guideline sets out how drug treatments for neuropathic pain differ from traditional pain management. MHRA advice on valproate: In April 2018, we added warnings that valproate must not be used in pregnancy, and only used in girls and women when there is no alternative and a pregnancy prevention plan is in place. This is because of the risk of malformations and developmental abnormalities in the baby. See update information for details. The MHRA has published temporary advice on the valproate pregnancy prevention programme during the COVID-19 pandemic. MHRA advice on pregabalin and gabapentin: In July 2019, we updated footnotes in this guideline to reflect a change in the law relating to pregabalin and gabapentin. As of 1 April 2019, because of a risk of abuse and dependence, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as class C substances and scheduled under the Misuse of Drugs Regulations 2001 as schedule 3.WHO IS IT FOR? Healthcare professionals. Adults with neuropathic pain, their families and carers.

*31961628*
 31961628

Roundtable on Data Science Postsecondary Education: A Compilation of Meeting Highlights

Roundtable on Data Science Postsecondary Education: A Compilation of Meeting Highlights-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Established in December 2016, the National Academies of Sciences, Engineering, and Medicine's Roundtable on Data Science Postsecondary Education was charged with identifying the challenges of and highlighting best practices in postsecondary data science education. Convening quarterly for 3 years, representatives from academia, industry, and government gathered with other experts from across the nation to discuss various topics under this charge. The meetings centered on four central themes: foundations of data science; data science across the postsecondary curriculum; data science across society; and ethics and data science. This publication highlights the presentations and discussions of each meeting.

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 33074630

Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations

Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations-/- 2020; ():

More than 3.7 million U.S. service members have participated in operations taking place in the Southwest Asia Theater of Military Operations since 1990. These operations include the 1990-1991 Persian Gulf War, a post-war stabilization period spanning 1992 through September 2001, and the campaigns undertaken in the wake of the September 11, 2001, attacks. Deployment to Iraq, Kuwait, Saudi Arabia, Bahrain, Gulf of Aden, Gulf of Oman, Oman, Qatar, the United Arab Emirates, and Afghanistan exposed service members to a number of airborne hazards, including oil-well fire smoke, emissions from open burn pits, dust and sand suspended in the air, and exhaust from diesel vehicles. The effects of these were compounded by stressors like excessive heat and noise that are inevitable attributes of service in a combat environment. Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations reviews the scientific evidence regarding respiratory health outcomes in veterans of the Southwest Asia conflicts and identifies research that could feasibly be conducted to address outstanding questions and generate answers, newly emerging technologies that could aid in these efforts, and organizations that the Veterans Administration might partner with to accomplish this work.

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 33030852

Integrating the Science of Aging and Environmental Health Research: Proceedings of a Workshop-in Brief

Integrating the Science of Aging and Environmental Health Research: Proceedings of a Workshop-in Brief-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Understanding and ensuring healthy aging has become increasingly important as the human life span increases with each decade. The need to better understand the role of environmental exposures in the development of aging-related diseases, such as cardiovascular disease, cancer, and dementia, is now an important driver for research at the intersection of aging and environmental health. With that in mind, on June 9-10, 2020, the Standing Committee on the Use of Emerging Science for Environmental Health Decisions of the National Academies of Sciences, Engineering, and Medicine held a 1.5-day workshop to explore how environmental exposures influence or mediate aging and how aging influences environmentally mediated health outcomes. The workshop brought together a multidisciplinary group of experts who described the current state of knowledge in the field as well as ideas for next steps including research opportunities and needs, enabling technologies and analytical tools, and mechanisms to anticipate and use new data to inform environmental health decisions. This Proceedings of a Workshop in Brief summarizes the invited speakers' presentations and the discussion periods that followed each session.

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 32924387

NTP Research Report on the Scoping Review of Prenatal Exposure to Progestogens and Adverse Health Outcomes: Research Report 17

NTP Research Report on the Scoping Review of Prenatal Exposure to Progestogens and Adverse Health Outcomes: Research Report 17-/-NTP Research Reports 2020; ():

INTRODUCTION: Endogenous progesterone is a sex hormone, one role of which is to maintain the uterine lining to support pregnancy. Drugs that exert progesterone action, collectively called progestogens (or progestins), include bioidentical progesterone from plant sources and synthetic progestogens. Progestogens are administered to reproductive-aged women for a variety of reasons, including contraception, threatened miscarriage (or its prevention), and preterm birth (or its prevention), which create the potential for fetal exposure to these drugs. Case reports and case series of adverse reproductive development (e.g., virilization in female infants) have been documented after exposure to progestogens in the first trimester, and similar effects on reproductive development have been observed in nonhuman mammalian animal studies after in utero exposure to certain synthetic progestogens. OBJECTIVE: The objective of the scoping activities was to identify and characterize the literature on the possible association between exposure to progestogens (bioidentical progesterone or synthetic progestogens) during pregnancy and adverse pregnancy outcomes, congenital malformations, neurologic effects, cancer, and other health outcomes in offspring related to prenatal exposure. METHODS: The scoping review was conducted following the Office of Health Assessment and Translation's method for systematic review through an abbreviated data extraction step. A literature search was performed up to September 13, 2019, in PubMed, Cochrane Library, and Database of Abstracts of Reviews of Effects (through 2015) for references reporting on adverse neonatal outcomes, congenital malformations, neurological effects, and cancer incidence following in utero exposure to progestogens. Relevant references were characterized by evidence stream (e.g., animal, human, in vitro study), study design, exposure, and outcome, and by the indication for administration of the drug. An interactive evidence map was prepared to enable researchers to explore the health outcome data by exposure. Tables were developed to describe the human data on congenital malformations and neurodevelopmental outcomes. RESULTS: The literature search yielded 7,654 references of which 212 were relevant, including 123 epidemiological studies and 90 nonhuman animal studies and 1 that reported on both human and animal subjects. In these studies, 24 different progestogens were evaluated, and the most frequently reported exposures were bioidentical progesterone, 17-alpha-hydroxyprogesterone caproate (17OHPC), and medroxyprogesterone acetate. Congenital malformations were evaluated in 32 human studies with first-trimester exposure and in 32 animal studies. Genital organ malformations (e.g., hypospadias) were the most common congenital malformation evaluated. Exposures in studies reporting significantly higher rates of genital malformations primarily involved synthetic progestogens with known androgenic (e.g., allylestrenol, lynestrenol, norethindrone) or anti-androgenic (e.g., cyproterone acetate) activities. In contrast, 17OHPC did not appear to induce congenital malformations in either humans (five of five studies) or nonhuman mammalian animals (five of five studies) exposed during organogenesis. Anogenital distance (AGD) in animal studies followed a similar pattern with prenatal exposure to androgenic synthetic progestogens generally reported to be associated with a longer AGD in females (i.e., virilization), whereas prenatal exposures to anti-androgenic synthetic progestogens were associated with shorter AGD in males (i.e., demasculinization). DISCUSSION: The literature reporting on neurological outcomes (n = 61 studies) had several limitations, including few studies assessing similar endpoints and exposures or inconsistent results. Studies evaluating sexually dimorphic behavior in animals reported the most consistent findings for neurological effects; 12 of 14 studies reported altered mating behavior following prenatal exposure to bioidentical progesterone, 17OHPC, cyproterone acetate, or allylestrenol. Other limitations in the body of evidence of this scoping review included inconsistently used nomenclature for bioidentical progesterone and the synthetic progestogens and an inability to evaluate the data across progestogens as a group because of the unique biological activities of the progestogens administered (e.g., androgenic, anti-androgenic). This scoping review identified and characterized a limited body of evidence on potential adverse health effects associated with in utero exposure to progestogens. The evidence was not sufficient to recommend an evaluation by systematic review on the association of potential adverse health effects with prenatal exposure to progestogens due to limitations of the literature. These limitations included heterogeneity of the endpoints assessed within some outcome categories (e.g., neurological outcomes), inconsistent results, and inconsistently used nomenclature to identify bioidentical progesterone or the specific synthetic progestogens used. In addition, evaluating these exposures as a group was challenging because of the unique biological activities of the progestogens administered (e.g., androgenic, anti-androgenic). More research is needed to better understand the potential association of prenatal exposure to progestogens and adverse pregnancy outcomes, congenital malformation incidence, and longer-term health outcomes of prenatally exposed offspring (e.g., neurological effects and cancer).

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 33211446

NTP Research Report on the Scoping Review of Potential Human Health Effects Associated with Exposures to Neonicotinoid Pesticides: Research Report 15

NTP Research Report on the Scoping Review of Potential Human Health Effects Associated with Exposures to Neonicotinoid Pesticides: Research Report 15-/-NTP Research Reports 2020; ():

INTRODUCTION: Neonicotinoid pesticides are commonly used in the United States to control insects on domestic animals and as seed coatings on agricultural crops, such as corn and soybeans. In areas of widespread use, neonicotinoids have been observed in surface waters, produce, and prepared foods. Because these pesticides are neurotoxic to insects through insect nicotinic acetylcholine receptors (nAChRs), concerns have been raised as to whether neonicotinoids may bind to receptors in off-target species, including humans, and result in adverse health effects. The associations between exposures to neonicotinoid pesticides and potential human health effects were nominated by private individuals to the National Toxicology Program (NTP) as a potential candidate for systematic review in 2014. NTP later learned that the U.S. EPA Office of Pesticide Programs (OPP) was also evaluating currently registered neonicotinoid pesticides as part of registration review activities. Thus, NTP consulted with EPA and solicited public comments during problem formulation activities to maximize the utility of this report. OBJECTIVE: The objective of the scoping activities was to identify and summarize scientific literature indexed in PubMed reporting exposure to one or more neonicotinoid pesticides registered for use in the United States and any reported outcome relevant to human health effects. METHODS: A scoping review was conducted following the Office of Health Assessment and Translation (OHAT) method for systematic review through an abbreviated data extraction step. A comprehensive search strategy was used to retrieve original research records from PubMed that contained reports of exposure to any of seven neonicotinoid pesticides (acetamiprid, clothianidin, imidacloprid, nitenpyram, thiacloprid, thiamethoxam, and dinotefuran) and all reported outcomes relevant to human health effects, including epidemiological, experimental animal, and in vitro model systems. Records were screened at the title-and-abstract level for relevance according to pre-specified inclusion/exclusion criteria. Included records were then screened at the full-text level to verify relevance and manually categorize studies by exposure, outcome, study type, species, and cell type, where appropriate. RESULTS: A total of 191 studies were included as relevant to human health effects associated with exposure to neonicotinoid pesticides, including six epidemiological studies; 19 human case reports; and 113 experimental animal studies that included rodents, fish, Caenorhabditis elegans, and Drosophila. An interactive evidence map was prepared to allow exploration of the literature by pesticide, broad health effect categories, and evidence stream (e.g., human, animal, or in vitro). Most of the research focused on imidacloprid (n = 127 records). The most commonly reported outcome category across all evidence streams was neurological effects (n = 86), whereas congenital and developmental effects were investigated in four of the six epidemiological studies. For these health categories with the most records, the study designs including measured endpoints were captured to assess the consistency of measures for potential human health hazard evaluation. DISCUSSION: In this scoping review, NTP compiled publicly available scientific literature on neonicotinoid exposure and health effects and summarized the state of the science and limitations of the evidence base of these data to support further health hazard and risk assessments. Various health effects have been reported in these data to be associated with exposure to neonicotinoids. However, a limited body of evidence was identified for use in health hazard assessment, primarily due to the heterogeneity of investigated health outcomes and measured endpoints. This scoping review by design summarizes publicly available scientific literature indexed in PubMed only and does not include any proprietary studies available to EPA, which likely contain relevant toxicological data that would complement these data and allow for more comprehensive health hazard assessment.

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 33136351

NTP Research Report on the Scoping Review of Paraquat Dichloride Exposure and Parkinson's Disease: Research Report 16

NTP Research Report on the Scoping Review of Paraquat Dichloride Exposure and Parkinson's Disease: Research Report 16-/-NTP Research Reports 2020; ():

INTRODUCTION: Paraquat dichloride (commonly referred to as paraquat) is a restricted-use, broad-spectrum herbicide that is commonly used in the United States to control weeds in agricultural and horticultural crops. Because paraquat is not registered for home use, the highest exposures would likely be to those manufacturing and applying paraquat or to those living on or near farms or other areas where paraquat is manufactured or applied. Observational human studies of people who apply pesticides and data from experimental animal studies indicate that long-term, chronic exposure to paraquat might lead to central nervous system toxicity. The National Toxicology Program (NTP) identified paraquat as a potential candidate for systematic review while performing scoping activities to classify environmental exposures associated with Parkinson's disease. Subsequently, NTP became aware that the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) was also evaluating paraquat as part of registration review activities and collaborated with EPA to avoid duplication of effort. OBJECTIVE: The objective of these scoping activities was to identify and characterize peer-reviewed, published scientific literature relevant to paraquat exposure and neurobehavioral and neuropathological endpoints associated with Parkinson's disease in humans and to related models in experimental animals or in vitro studies. METHODS: A scoping review was conducted that followed the NTP Office of Health Assessment and Translation (OHAT) method for systematic review through an abbreviated data extraction step. A comprehensive search strategy was used to retrieve original research records from multiple databases (i.e., Embase, PubMed, Scopus, Web of Science, and TOXLINE) through May 24, 2018. Relevant records included reports of exposure to paraquat dichloride and neurobehavioral or neuropathological endpoints relevant to Parkinson's disease in humans (such as clinical diagnoses, movement abnormalities, and effects on dopaminergic neurons) in epidemiological studies, experimental animal models of parkinsonism, and in vitro model systems. References were screened in duplicate for relevance and categorized by exposure, outcome, species, and cell type, where appropriate. An interactive evidence map was prepared using Tableau((R)) software to enable researchers to explore the health outcome data by key feature (e.g., outcome, study type, animal model). Finally, data extraction of quantitative results was performed using the Health Assessment Workspace Collaborative (HAWC) software for those studies that were the most directly relevant to human Parkinson's disease (e.g., epidemiological studies reporting primary outcomes and studies of mammals exposed to paraquat via exposure routes most representative of human exposures including oral, dermal, and inhalation). RESULTS: The literature search identified 8,685 references, 458 of which were included after screening as relevant to describing the association between exposure to paraquat and the potential development of Parkinson's disease with some reports consisting of multiple lines of evidence and measured endpoints. The human epidemiological evidence consisted of 24 studies with the majority conducted in agricultural workers or people living in or near agricultural areas. A total of 143 experimental animal studies reported measurement of primary health endpoints; 11 were found to have high external validity to human exposure by exposing mammals via a route similar to human exposures (i.e., oral, inhalation, dermal). Supporting mechanistic information was reported in 190 experimental animal studies measuring secondary health endpoints and 244 in vitro studies. DISCUSSION: Using systematic review methodologies, NTP developed a scoping review and evidence maps of published scientific literature to support potential follow-up systematic review and to identify extant research gaps. The evidence maps are interactive, sortable visualizations of quantitative data from epidemiological studies and experimental study characteristics with links to publications. A considerable body of evidence was identified as relevant to paraquat exposure and Parkinson's disease that can be used in developing future systematic reviews as were data gaps and scientific challenges that could be addressed by future research.

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 33104309

Evidence review for pharmacological management of sciatica: Low back pain and sciatica in over 16s: assessment and management: Evidence review A

Evidence review for pharmacological management of sciatica: Low back pain and sciatica in over 16s: assessment and management: Evidence review A-/- 2020; ():

Sciatica is a general term for pain in the leg as a result of nerve compression or irritation in the lumbar spine. This is sometimes referred to as radicular pain. Many people with low back pain have referred pain in the leg, without nerve compression. The commonest cause is impingement or inflammation of the lumbosacral nerve roots and is frequently associated with herniation of a lumbar intervertebral disc. In older people, additional anatomical changes may be important. Anatomical structures and abnormal movement in the back can also cause pain to be felt or 'referred' to the leg. It can be difficult to differentiate referred pain from sciatica, and the two may co-exist. The pharmacological management of back pain, including referred pain, was included in 'Low back pain and sciatica in over 16s: assessment and management' (NG59). People with sciatica typically have severe pain at onset and a slower and less complete recovery than people with back pain without sciatica. A review of pharmacological interventions for sciatica is important because people with sciatica commonly present in primary care. Drugs for neuropathic pain are frequently prescribed for sciatica in addition to opioids and other analgesics. There is high variability of prescribing volumes between CCGs and different population groups. A significant proportion of people continue taking medication for sciatica in the longer term. When NG59 was first published in 2016, the guideline cross-referenced 'Neuropathic pain in adults: pharmacological management in non-specialist settings' (CG173) for the pharmacological management of sciatica. A MHRA drug safety update in April 2019 advised that gabapentin and pregabalin were reclassified as controlled drugs. This triggered an exceptional surveillance review for NG59. The frequent presentation for relief of leg pain associated with back pain and sciatica in primary care, the unknown efficacy of drugs for neuropathic pain in sciatica, and the reclassification of some drugs used to treat sciatica coupled with the variation in prescribing patterns warrants a fresh review of the pharmacological management of sciatica.

*33090751*
 33090751

Diagnosis and Management of Acute HIV

Diagnosis and Management of Acute HIV-/-New York State Department of Health AIDS Institute Clinical Guidelines 2020; ():

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 33074631

Supporting good quality, community-based end-of-life care for people living with dementia: the SEED research programme including feasibility RCT

Supporting good quality, community-based end-of-life care for people living with dementia: the SEED research programme including feasibility RCT-/-Programme Grants for Applied Research 2020; ():

BACKGROUND: In the UK, most people with dementia die in the community and they often receive poorer end-of-life care than people with cancer. OBJECTIVE: The overall aim of this programme was to support professionals to deliver good-quality, community-based care towards, and at, the end of life for people living with dementia and their families. DESIGN: The Supporting Excellence in End-of-life care in Dementia (SEED) programme comprised six interlinked workstreams. Workstream 1 examined existing guidance and outcome measures using systematic reviews, identified good practice through a national e-survey and explored outcomes of end-of-life care valued by people with dementia and family carers (n = 57) using a Q-sort study. Workstream 2 explored good-quality end-of-life care in dementia from the perspectives of a range of stakeholders using qualitative methods (119 interviews, 12 focus groups and 256 observation hours). Using data from workstreams 1 and 2, workstream 3 used co-design methods with key stakeholders to develop the SEED intervention. Worksteam 4 was a pilot study of the SEED intervention with an embedded process evaluation. Using a cluster design, we assessed the feasibility and acceptability of recruitment and retention, outcome measures and our intervention. Four general practices were recruited in North East England: two were allocated to the intervention and two provided usual care. Patient recruitment was via general practitioner dementia registers. Outcome data were collected at baseline, 4, 8 and 12 months. Workstream 5 involved economic modelling studies that assessed the potential value of the SEED intervention using a contingent valuation survey of the general public (n = 1002). These data informed an economic decision model to explore how the SEED intervention might influence care. Results of the model were presented in terms of the costs and consequences (e.g. hospitalisations) and, using the contingent valuation data, a cost-benefit analysis. Workstream 6 examined commissioning of end-of-life care in dementia through a narrative review of policy and practice literature, combined with indepth interviews with a national sample of service commissioners (n = 20). SETTING: The workstream 1 survey and workstream 2 included services throughout England. The workstream 1 Q-sort study and workstream 4 pilot trial took place in North East England. For workstream 4, four general practices were recruited; two received the intervention and two provided usual care. RESULTS: Currently, dementia care and end-of-life care are commissioned separately, with commissioners receiving little formal guidance and training. Examples of good practice rely on non-recurrent funding and leadership from an interested clinician. Seven key components are required for good end-of-life care in dementia: timely planning discussions, recognising end of life and providing supportive care, co-ordinating care, effective working with primary care, managing hospitalisation, continuing care after death, and valuing staff and ongoing learning. Using co-design methods and the theory of change, the seven components were operationalised as a primary care-based, dementia nurse specialist intervention, with a care resource kit to help the dementia nurse specialist improve the knowledge of family and professional carers. The SEED intervention proved feasible and acceptable to all stakeholders, and being located in the general practice was considered beneficial. None of the outcome measures was suitable as the primary outcome for a future trial. The contingent valuation showed that the SEED intervention was valued, with a wider package of care valued more than selected features in isolation. The SEED intervention is unlikely to reduce costs, but this may be offset by the value placed on the SEED intervention by the general public. LIMITATIONS: The biggest challenge to the successful delivery and completion of this research programme was translating the 'theoretical' complex intervention into practice in an ever-changing policy and service landscape at national and local levels. A major limitation for a future trial is the lack of a valid and relevant primary outcome measure to evaluate the effectiveness of a complex intervention that influences outcomes for both individuals and systems. CONCLUSIONS: Although the dementia nurse specialist intervention was acceptable, feasible and integrated well with existing care, it is unlikely to reduce costs of care; however, it was highly valued by all stakeholders (professionals, people with dementia and their families) and has the potential to influence outcomes at both an individual and a systems level. FUTURE WORK: There is no plan to progress to a full randomised controlled trial of the SEED intervention in its current form. In view of new National Institute for Health and Care Excellence dementia guidance, which now recommends a care co-ordinator for all people with dementia, the feasibility of providing the SEED intervention throughout the illness trajectory should be explored. Appropriate outcome measures to evaluate the effectiveness of such a complex intervention are needed urgently. TRIAL REGISTRATION: Current Controlled Trials ISRCTN21390601. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research, Vol. 8, No. 8. See the NIHR Journals Library website for further project information.

*33017109*
 33017109

Registries for Evaluating Patient Outcomes: A User's Guide

Registries for Evaluating Patient Outcomes: A User's Guide-/-AHRQ Methods for Effective Health Care 2020; ():

*33001604*
 33001604

An online supported self-management toolkit for relatives of people with psychosis or bipolar experiences: the IMPART multiple case study

An online supported self-management toolkit for relatives of people with psychosis or bipolar experiences: the IMPART multiple case study-/-Health Services and Delivery Research 2020; ():

BACKGROUND: Digital health interventions have the potential to improve the delivery of psychoeducation to people with mental health problems and their relatives. Despite substantial investment in the development of digital health interventions, successful implementation into routine clinical practice is rare. OBJECTIVES: Use the implementation of the Relatives' Education And Coping Toolkit (REACT) for psychosis/bipolar disorder to identify critical factors affecting uptake and use, and develop an implementation plan to support the delivery of REACT. DESIGN: This was an implementation study using a mixed-methods, theory-driven, multiple case study approach. A study-specific implementation theory for REACT based on normalisation process theory was developed and tested, and iterations of an implementation plan to address the key factors affecting implementation were developed. SETTING: Early-intervention teams in six NHS mental health trusts in England (three in the north and three in the south). PARTICIPANTS: In total, 281 staff accounts and 159 relatives' accounts were created, 129 staff and 23 relatives took part in qualitative interviews about their experiences, and 132 relatives provided demographic data, 56 provided baseline data, 21 provided data at 12 weeks' follow-up and 20 provided data at 24 weeks' follow-up. INTERVENTIONS: REACT is an online supported self-management toolkit, offering 12 evidence-based psychoeducation modules and support via a forum, and a confidential direct messaging service for relatives of people with psychosis or bipolar disorder. The implementation intervention was developed with staff and iteratively adapted to address identified barriers. Adaptations included modifications to the toolkit and how it was delivered by teams. MAIN OUTCOME MEASURES: The main outcome was factors affecting implementation of REACT, assessed primarily through in-depth interviews with staff and relatives. We also assessed quantitative measures of delivery (staff accounts and relatives' invitations), use of REACT (relatives' logins and time spent on the website) and the impact of REACT [relatives' distress (General Health Questionnaire-28), and carer well-being and support (Carer Well-being and Support Scale questionnaire)]. RESULTS: Staff and relatives were generally positive about the content of REACT, seeing it as a valuable resource that could help services improve support and meet clinical targets, but only within a comprehensive service that included face-to-face support, and with some additional content. Barriers to implementation included high staff caseloads and difficulties with prioritising supporting relatives; technical difficulties of using REACT; poor interoperability with trust information technology systems and care pathways; lack of access to mobile technology and information technology training; restricted forum populations leading to low levels of use; staff fears of managing risk, online trolling, or replacement by technology; and uncertainty around REACT's long-term availability. There was no evidence that REACT would reduce staff time supporting relatives (which was already very low), and might increase it by facilitating communication. In all, 281 staff accounts were created, but only 57 staff sent relatives invitations. In total, 355 relatives' invitations were sent to 310 unique relatives, leading to the creation of 159 relatives' accounts. The mean number of logins for relatives was 3.78 (standard deviation 4.43), but with wide variation from 0 to 31 (median 2, interquartile range 1-8). The mean total time spent on the website was 40.6 minutes (standard deviation 54.54 minutes), with a range of 0-298 minutes (median 20.1 minutes, interquartile range 4.9-57.5 minutes). There was a pattern of declining mean scores for distress, social dysfunction, depression, anxiety and insomnia, and increases in relatives' well-being and eHealth literacy, but no changes were statistically significant. CONCLUSIONS: Digital health interventions, such as REACT, should be iteratively developed, evaluated, adapted and implemented, with staff and service user input, as part of a long-term strategy to develop integrated technology-enabled services. Implementation strategies must instil a sense of ownership for staff and ensure that they have adequate training, risk protocols and resources to deliver the technology. Cost-effectiveness and impact on workload and inequalities in accessing health care need further testing, along with the generalisability of our findings to other digital health interventions. LIMITATIONS: REACT was offered by the same team running the IMPlementation of A Relatives' Toolkit (IMPART) study, and was perceived by staff and relatives as a time-limited research study rather than ongoing clinical service, which affected engagement. Access to observational data was limited. TRIAL REGISTRATION: Current Controlled Trials ISRCTN16267685. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 37. See the NIHR Journals Library website for further project information.

*32986342*
 32986342

Therapies for Clinically Localized Prostate Cancer

Therapies for Clinically Localized Prostate Cancer-/-AHRQ Comparative Effectiveness Reviews 2020; ():

OBJECTIVE: To update findings from previous Agency for Healthcare Research and Quality (AHRQ)- and American Urological Association (AUA)-funded reviews evaluating therapies for clinically localized prostate cancer (CLPC). SOURCES: Bibliographic databases (2013-January 2020); ClinicalTrials.gov; systematic reviews METHODS: Controlled studies of CLPC treatments with duration >/=5 years for mortality and metastases and >/=1 year for quality of life and harms. One investigator rated risk of bias (RoB), extracted data, and assessed certainty of evidence; a second checked accuracy. We analyzed English-language studies with low or medium RoB. We incorporated findings from randomized controlled trials (RCTs) identified in the prior reviews if new RCTs provided information on the same intervention comparison. RESULTS: We identified 67 eligible references; 17 were unique RCTs. Among clinically rather than prostate-specific antigen (PSA) detected CLPC, Watchful Waiting (WW) may increase mortality and metastases versus Radical Prostatectomy (RP) at 20+ years. Urinary and erectile dysfunction were lower with WW versus RP. WW's effect on mortality may vary by tumor risk and age but not by race, health status, comorbidities, or PSA. Active Monitoring (AM) probably results in little to no difference in mortality in PSA-detected CLPC versus RP or external beam radiation (EBR) plus Androgen Deprivation (AD) regardless of tumor risk. Metastases were slightly higher with AM. Harms were greater with RP than AM and mixed between EBR plus AD versus AM. 3D-conformal EBR and AD plus low-dose-rate brachytherapy (BT) provided a small reduction in all-cause mortality versus three-dimensional conformal EBR and AD but little to no difference on metastases. EBR plus AD versus EBR alone may result in a small reduction in mortality and metastases in higher risk disease but may increase sexual harms. EBR plus neoadjuvant AD versus EBR plus concurrent AD may result in little to no difference in mortality and genitourinary toxicity. Conventionally fractionated EBR versus ultrahypofractionated EBR may result in little to no difference in mortality and metastases and urinary and bowel toxicity. Active Surveillance may result in fewer harms than photodynamic therapy and laparoscopic RP may result in more harms than robotic-assisted RP. Little information exists on other treatments. No studies assessed provider or hospital factors of RP comparative effectiveness. CONCLUSIONS: RP reduces mortality versus WW in clinically detected CLPC but causes more harms. Effectiveness may be limited to younger men or to those with intermediate-risk disease and requires many years to occur. AM results in little to no mortality difference versus RP or EBR plus AD. EBR plus AD reduces mortality versus EBR alone in higher risk CLPC but may worsen sexual function. Adding low-dose-rate BT to 3D-conformal EBR and AD may reduce mortality in higher risk CLPC. RCTs in PSA-detected and MRI staged CLPC are needed.

*32986341*
 32986341

Developing Consistent and Useful Quality Improvement Study Data Extraction for Health Systems

Developing Consistent and Useful Quality Improvement Study Data Extraction for Health Systems-/-AHRQ Methods for Effective Health Care 2020; ():

BACKGROUND: Quality improvement studies can provide important insight to learning health systems. The Agency for Healthcare Research and Quality (AHRQ) could devote resources to collate and assess these quality improvement studies to support learning health systems (LHS) but there is no reliable data on the consistency of data extraction for important criteria. METHODS: We identified quality improvement studies in asthma and evaluated the consistency of data extraction from two experienced independent reviewers at three time points: baseline where only a rudimentary description of the criteria was available, first revision where explicit instructions for each criterion were created, and final revision where the instructions were revised. Six investigators looked at the data extracted by one of the systematic reviewers and then the other for the same criteria and determined the extent of similarity on a scale of 0 to 10 (where 0 represented no similarity and 10 perfect similarity). There were 42 assessments for baseline, 42 assessments for the first revision, and 42 assessments for the final revision. We then asked two LHS participants to assess the relative value of our criteria in a pilot phase. RESULTS: We went through two refinements of the data extraction instructions for each criterion and were able to improve the consistency of extraction from 1.17+/-1.85 at baseline to 6.07+/-2.76 after revision one (P<0.001) and to 6.81+/-1.94 out of 10 for the final revision (P<0.001). However, the final revision was not significantly improved over revision one (p=0.14). In the pilot phase, our two LHS participants felt that some of our 33 criteria were more valuable than others were. DISCUSSION/CONCLUSION: Creating explicit instructions for extracting data for quality improvement study helps enhance the consistency of data extraction. Future studies with a larger cadre of LHS participants should help determine the most important criteria.

*32965807*
 32965807

Behaviour change interventions to reduce risky substance use and improve mental health in children in care: the SOLID three-arm feasibility RCT

Behaviour change interventions to reduce risky substance use and improve mental health in children in care: the SOLID three-arm feasibility RCT-/-Public Health Research 2020; ():

BACKGROUND: Looked-after children and care leavers (henceforth children in care) are young people placed under the care of local authorities, often because of a history of family abuse and/or neglect. These young people have significantly increased risk of substance use and mental health problems compared with peers. AIM: The Supporting Looked After Children and Care Leavers In Decreasing Drugs, and alcohol (SOLID) trial aimed to investigate the feasibility of a definitive randomised controlled trial comparing two behaviour change interventions to reduce risky substance use (illicit drugs and alcohol) in and improve the mental health of children in care aged 12-20 years. METHODS: The study consisted of two phases: (1) a formative phase that adapted the motivational enhancement therapy and social behaviour and network therapy interventions for use with children in care and (2) a three-arm pilot randomised controlled trial (comparing motivational enhancement therapy, social behaviour and network therapy and usual care), and a linked process and economic (return on investment) evaluation. Trial feasibility was compared with prespecified STOP/GO criteria. SETTING: Six local authority areas in the north-east of England. PARTICIPANTS: Children in care (aged 12-20 years) who screened positive for drug and/or alcohol use within the last 12 months were eligible for the trial. The formative and process evaluations included children in care, carers, social workers, and drug and alcohol workers. OUTCOME MEASURES: The primary outcomes were recruitment and retention rates at 12 months' follow-up. Baseline and 12-month follow-up questionnaires measured self-reported drug and alcohol use, mental health and health-related quality of life. The process evaluation considered acceptability and engagement with the interventions and trial procedures. RESULTS: Formative findings (n = 65) highlighted the need for interventions to increase the emphasis on therapeutic relationships, use creative methods of engagement and support the identification of treatment goals wider than substance misuse. Within the randomised controlled trial, of 860 participants screened, 211 (24.5%) met the inclusion criteria. One hundred and twelve (53%) of the 211 eligible children were recruited and randomised. Just 15 of the 76 (20%) participants allocated to intervention attended any of the motivational enhancement therapy of social behaviour and network therapy sessions, and 60 (54%) participants completed the 12-month follow-up. The screening and recruitment of children in care required significantly more time and resource investment by researchers and children's services than planned. The process evaluation (n = 116) demonstrated that, despite participants engaging in risky substance use, they did not often acknowledge this nor felt that they needed help. Children in care had complex, chaotic lives and children's services departments were less research mature and extremely stretched; this, coupled with the multiple steps in the intervention pathway and study protocol, resulted in low adherence to the intervention and the trial. CONCLUSIONS: The SOLID trial demonstrated successful engagement with children in care to adapt the motivational enhancement therapy and social behaviour and network therapy interventions. However, the pilot randomised controlled trial found that a definitive trial is not feasible. The current screen, refer and treat pathway for children in care did not work. There is an urgent need to radically rethink how we deliver therapeutic services for children in care. A pragmatic evaluation design, coupled with additional research resource for children's services, is needed to evaluate these novel models of care at scale. TRIAL REGISTRATION: This study is registered as PROSPERO CRD42018098974 and Current Controlled Trials ISRCTN80786829. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 13. See the NIHR Journals Library website for further project information.

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 32960519

The epidemiology, management and impact of surgical wounds healing by secondary intention: a research programme including the SWHSI feasibility RCT

The epidemiology, management and impact of surgical wounds healing by secondary intention: a research programme including the SWHSI feasibility RCT-/-Programme Grants for Applied Research 2020; ():

BACKGROUND: Most surgical incisions heal by primary intention (i.e. wound edges are apposed with sutures, clips or glue); however, some heal by secondary intention (i.e. the wound is left open and heals by formation of granulation tissue). There is, however, a lack of evidence regarding the epidemiology, management and impact on patients' quality of life of these surgical wounds healing by secondary intention, resulting in uncertainty regarding effective treatments and difficulty in planning care and research. OBJECTIVES: To derive a better understanding of the nature, extent, costs, impact and outcomes of surgical wounds healing by secondary intention, effective treatments, and the value and nature of further research. DESIGN: Cross-sectional survey; inception cohort; cost-effectiveness and value of implementation analyses; qualitative interviews; and pilot, feasibility randomised controlled trial. SETTING: Acute and community care settings in Leeds and Hull, Yorkshire, UK. PARTICIPANTS: Adults (or for qualitative interviews, patients or practitioners) with previous experience of a surgical wound healing by secondary intention. Inclusion criteria varied between the individual workstreams. INTERVENTIONS: The pilot, feasibility randomised controlled trial compared negative-pressure wound therapy - a device applying a controlled vacuum to a wound via a dressing - with usual care (no negative-pressure wound therapy). RESULTS: Survey data estimated that treated surgical wounds healing by secondary intention have a point prevalence of 4.1 per 10,000 population (95% confidence interval 3.5 to 4.7 per 10,000 population). Surgical wounds healing by secondary intention most frequently occurred following colorectal surgery (n = 80, 42.8% cross-sectional survey; n = 136, 39.7% inception cohort) and were often planned before surgery (n = 89, 47.6% cross-sectional survey; n = 236, 60.1% inception cohort). Wound care was frequently delivered in community settings (n = 109, 58.3%) and most patients (n = 184, 98.4%) received active wound treatment. Cohort data identified hydrofibre dressings (n = 259, 65.9%) as the most common treatment, although 29.3% (n = 115) of participants used negative-pressure wound therapy at some time during the study. Surgical wounds healing by secondary intention occurred in 81.4% (n = 320) of participants at a median of 86 days (95% confidence interval 75 to 103 days). Baseline wound area (p

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 32960518

Active design of built environments for increasing levels of physical activity in adults: the ENABLE London natural experiment study

Active design of built environments for increasing levels of physical activity in adults: the ENABLE London natural experiment study-/-Public Health Research 2020; ():

BACKGROUND: Low physical activity is widespread and poses a serious public health challenge both globally and in the UK. The need to increase population levels of physical activity is recognised in current health policy recommendations. There is considerable interest in whether or not the built environment influences health behaviours, particularly physical activity levels, but longitudinal evidence is limited. OBJECTIVES: The effect of moving into East Village (the former London 2012 Olympic and Paralympic Games Athletes' Village, repurposed on active design principles) on the levels of physical activity and adiposity, as well as other health-related and well-being outcomes among adults, was examined. DESIGN: The Examining Neighbourhood Activities in Built Environments in London (ENABLE London) study was a longitudinal cohort study based on a natural experiment. SETTING: East Village, London, UK. PARTICIPANTS: A cohort of 1278 adults (aged >/= 16 years) and 219 children seeking to move into social, intermediate and market-rent East Village accommodation were recruited in 2013-15 and followed up after 2 years. INTERVENTION: The East Village neighbourhood, the former London 2012 Olympic and Paralympic Games Athletes' Village, is a purpose-built, mixed-use residential development specifically designed to encourage healthy active living by improving walkability and access to public transport. MAIN OUTCOME MEASURE: Change in objectively measured daily steps from baseline to follow-up. METHODS: Change in environmental exposures associated with physical activity was assessed using Geographic Information System-derived measures. Individual objective measures of physical activity using accelerometry, body mass index and bioelectrical impedance (per cent of fat mass) were obtained, as were perceptions of change in crime and quality of the built environment. We examined changes in levels of physical activity and adiposity using multilevel models adjusting for sex, age group, ethnic group, housing sector (fixed effects) and baseline household (random effect), comparing the change in those who moved to East Village (intervention group) with the change in those who did not move to East Village (control group). Effects of housing sector (i.e. social, intermediate/affordable, market-rent) as an effect modifier were also examined. Qualitative work was carried out to provide contextual information about the perceived effects of moving to East Village. RESULTS: A total of 877 adults (69%) were followed up after 2 years (mean 24 months, range 19-34 months, postponed from 1 year owing to the delayed opening of East Village), of whom 50% had moved to East Village; insufficient numbers of children moved to East Village to be considered further. In adults, moving to East Village was associated with only a small, non-significant, increase in mean daily steps (154 steps, 95% confidence interval -231 to 539 steps), more so in the intermediate sector (433 steps, 95% confidence interval -175 to 1042 steps) than in the social and market-rent sectors (although differences between housing sectors were not statistically significant), despite sizeable improvements in walkability, access to public transport and neighbourhood perceptions of crime and quality of the built environment. There were no appreciable effects on time spent in moderate to vigorous physical activity or sedentary time, body mass index or percentage fat mass, either overall or by housing sector. Qualitative findings indicated that, although participants enjoyed their new homes, certain design features might actually serve to reduce levels of activity. CONCLUSIONS: Despite strong evidence of large positive changes in neighbourhood perceptions and walkability, there was only weak evidence that moving to East Village was associated with increased physical activity. There was no evidence of an effect on markers of adiposity. Hence, improving the physical activity environment on its own may not be sufficient to increase population physical activity or other health behaviours. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 12. See the NIHR Journals Library website for further project information. This research was also supported by project grants from the Medical Research Council National Prevention Research Initiative (MR/J000345/1).

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 32960517

Immediate versus delayed short-term integrated palliative care for advanced long-term neurological conditions: the OPTCARE Neuro RCT

Immediate versus delayed short-term integrated palliative care for advanced long-term neurological conditions: the OPTCARE Neuro RCT-/-Health Services and Delivery Research 2020; ():

BACKGROUND: Palliative care is recommended to help meet the needs of patients with progressive non-cancer conditions, such as long-term neurological conditions. However, few trials have tested palliative care in this population. OBJECTIVES: To determine the effectiveness and cost-effectiveness of short-term integrated palliative care in improving symptoms, improving patient- and caregiver-reported outcomes and reducing hospital use for people severely affected by long-term neurological conditions. DESIGN: Pragmatic, randomised controlled, multicentre, fast-track trial, with an embedded qualitative component and surveys. SETTING: Seven UK centres (South London, Nottingham, Liverpool, Cardiff, Brighton, Ashford and Sheffield) with multiprofessional palliative care teams and neurology services. PARTICIPANTS: People living with multiple sclerosis, idiopathic Parkinson's disease, motor neurone disease, multiple system atrophy or progressive supranuclear palsy, with unresolved symptoms and/or complex psychosocial needs. The qualitative study involved patients, caregivers and health-care staff. INTERVENTIONS: Participants were randomised to receive short-term integrated palliative care, delivered by multiprofessional teams, immediately or after a 12-week wait (standard care group). MAIN OUTCOME MEASURES: The primary outcome was a combined score of eight symptoms measured by the Integrated Palliative care Outcome Scale for Neurological conditions 8 symptom subscale (IPOS Neuro-S8) at 12 weeks. Secondary outcomes included patients' other physical and psychological symptoms, quality of life (EuroQol-5 Dimensions, five-level version), care satisfaction, caregiver burden, service use and cost, and harms. Data were analysed using multiple imputation, generalised linear mixed models, incremental cost-effectiveness ratios (threshold was the National Institute for Health and Care Excellence pound20,000 per quality-adjusted life-year) and cost-effectiveness planes. Qualitative data were analysed thematically. RESULTS: We recruited 350 patients and 229 caregivers. There were no significant between-group differences for primary or secondary outcomes. Patients receiving short-term integrated palliative care had a significant improvement, from baseline to 12 weeks, on the primary outcome IPOS Neuro-S8 (-0.78, 95% confidence interval -1.29 to -0.26) and the secondary outcome of 24 physical symptoms (-1.95, 99.55% confidence interval -3.60 to -0.30). This was not seen in the control group, in which conversely, care satisfaction significantly reduced from baseline to 12 weeks (-2.89, 99.55% confidence interval -5.19 to -0.59). Incremental cost-effectiveness ratios were smaller than the set threshold (EuroQol-5 Dimensions index score - pound23,545; IPOS Neuro-S8 - pound1519), indicating that the intervention provided cost savings plus better outcomes. Deaths, survival and hospitalisations were similar between the two groups. Qualitative data suggested that the impact of the intervention encompassed three themes: (1) adapting to losses and building resilience, (2) attending to function, deficits and maintaining stability, and (3) enabling caregivers to care. CONCLUSIONS: Our results indicate that short-term integrated palliative care provides improvements in patient-reported physical symptoms at a lower cost and without harmful effects when compared with standard care. LIMITATIONS: Outcome measures may not have been sensitive enough to capture the multidimensional changes from the intervention. Our surveys found that the control/standard and intervention services were heterogeneous. FUTURE WORK: Refining short-term integrated palliative care and similar approaches for long-term neurological conditions, focusing on better integration of existing services, criteria for referral and research to improve symptom management. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18337380. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 36. See the NIHR Journals Library website for further project information.

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 32902934

Text messaging and financial incentives to encourage weight loss in men with obesity: the Game of Stones feasibility RCT

Text messaging and financial incentives to encourage weight loss in men with obesity: the Game of Stones feasibility RCT-/-Public Health Research 2020; ():

BACKGROUND: In 2016, 26% of UK men were estimated to be obese. Systematic reviews suggest that few men engage in formal weight loss interventions that support weight reduction and improve health. OBJECTIVE: To co-produce, with patient and public involvement, an acceptable and feasible randomised controlled trial design to test a men-only weight management intervention. DESIGN: This was a two-phase feasibility study. Phase 1 was the development of intervention components, study procedures and materials including a discrete choice experiment with survey questions. Phase 2 was an individually randomised three-arm feasibility trial over 12 months. Qualitative interviews were conducted at 3 and 12 months. SETTING: The setting was two sites in Scotland that had disadvantaged urban and rural areas and differed in employment levels and ethnic groups. PARTICIPANTS: In phase 1, 1045 men with obesity were recruited by Ipsos MORI (London, UK; www.ipsos.com/ipsos-mori/en-uk) to represent the UK population. In phase 2, 105 men with obesity were recruited in the community or through general practice obesity registers. Qualitative interviews were conducted with 50 men at 3 months and with 33 men at 12 months. INTERVENTIONS: The trial arms were narrative short message service (SMS) for 12 months (SMS only), financial endowment incentive informed by loss aversion and linked to achievement of weight loss targets plus narrative SMS for 12 months (SMS + I), and waiting list control group for 12 months followed by 3 months of an alternative SMS style developed based on feedback from men who had received the narrative SMS (control). MAIN OUTCOME MEASURES: The main outcome measures were acceptability and feasibility of recruitment, retention, engagement, intervention components and trial procedures. Outcomes were assessed by examining procedural, quantitative and qualitative data at 3, 6 and 12 months. RESULTS: The most acceptable incentive strategy, based on the discrete choice experiment results, was to verify weight loss of 5% at 3 months, verify weight loss of 10% at 6 months and maintain weight loss of 10% at 12 months. Overall, 105 men with obesity from across the socioeconomic spectrum were successfully recruited to target, 59% of whom lived in more disadvantaged areas. Retention at 12 months was acceptable (74%) and was higher among individuals from disadvantaged areas. Narrative SMS were acceptable to many men, with a minority reporting negative reactions. Incentives were acceptable but were not the primary motivation for behaviour change. Twelve men in the incentive arm (33%) secured at least some money and three (8%) secured the full amount. Both intervention arms lost some weight, with greater weight loss in the arm that received SMS and incentives. The alternative SMS based on men's feedback received no strong negative reactions. LIMITATIONS: Fewer participants from the SMS + I arm (64%) completed the study at 12 months than did those in the SMS-only (79%) and control (83%) arms. The reasons for this difference were complex. CONCLUSIONS: The men-only weight management intervention consisting of narrative SMS and financial incentives was acceptable and feasible, meeting the progression criteria for a full trial. Tailoring of SMS may improve acceptability and retention. FUTURE WORK: Minor refinements to the intervention components based on the study findings will be made prior to testing in a multisite definitive randomised controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT03040518. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 11. See the NIHR Journals Library website for further project information.

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 32902933

Suicidal crises in unipolar depression: How do non-drug interventions impact their management? IQWiG Reports - Commission No. HT17-03

Suicidal crises in unipolar depression: How do non-drug interventions impact their management? IQWiG Reports - Commission No. HT17-03-/-Institute for Quality and Efficiency in Health Care: Extracts 2020; ():

RESEARCH QUESTIONS OF THE HTA REPORT: The aims of this investigation are to - assess the benefit of (1) crisis intervention programmes/services or (2) psychosocial interventions (technology based or not) in outpatient care in comparison with a different non-drug therapy, drug therapy, inpatient treatment, or no therapy / waiting list in adult suicidal patients with unipolar depression with regard to patient-relevant outcomes, - determine the costs incurred by (1) crisis intervention programmes/services or (2) psychosocial interventions (technology based or not) in outpatient care in comparison with a different non-drug therapy, drug therapy, inpatient treatment, or no therapy / waiting list in adult suicidal patients with unipolar depression (intervention costs), - assess the cost effectiveness of (1) crisis intervention programmes/services or (2) psychosocial interventions in outpatient care (technology based or not) in comparison with another non-drug therapy, drug therapy, inpatient treatment, or no therapy / waiting list in adult suicidal patients with unipolar depression was well as - review ethical, social, legal, and organizational aspects associated with the medical interventions. CONCLUSION OF THE HTA REPORT (SEE CHAPTER 9): To answer the question submitted to ThemenCheck, "Suicidal crises in unipolar depression: How do non-drug measures impact their management?", the following interventions were investigated: (1) crisis intervention programmes/services in outpatient care and (2) psychosocial interventions in outpatient care, namely (i) psychotherapeutic strategies for preventing suicide and (ii) suicide preventive follow-up services and contact offers. Despite this initially broad definition of interventions to be investigated in the outpatient care of adult suicidal patients with unipolar depression, only studies on cognitive behavioural therapy (CBT) were found, all of which focused on suicidality. These studies examined CBTs from the second and third "waves" of behavioural therapy (BT). The second wave of BT originated in the developments of the 1960s and 1970s, where classic BT was for the first time expanded to include cognitive aspects such as thoughts and convictions. In the 1980s, these considerations led to the approach of CBT. In the third wave of BT, the classic cognitive-behavioural concept, which largely focuses on restructuring processes, is expanded by the additional aspects of mindfulness and acceptance of difficult-to-control internal experiences. Additional conceptual differences concern the fundamental attitude and the patient-therapist relationship. CBT is a service already covered by the statutory health insurance. Four randomized controlled trials (RCTs) of moderate qualitative certainty of results were included. They primarily investigated the patient-relevant outcomes of anxiety, depressive symptoms, hopelessness, posttraumatic stress, suicidal ideation, and (follow-up) suicide attempts, each at the survey time points of 1, 3, 6, 18, and >/= 18 months. With regard to the patient-relevant outcomes of suicidal ideation (6 months), suicide attempts (>/= 18 months), depressive symptoms (3, 6, and 18 months), and hopelessness (6 and 18 months), the results revealed an indication of (added) benefit of second-wave CBT in comparison with treatment as usual (TAU). With regard to the patient-relevant outcome of depressive symptoms, the results revealed a hint of (added) benefit at the survey time point of 1 month for third-wave CBT in comparison with TAU. These results are based on the data from one study. The currently still outstanding results from another study might supplement the results of this health technology assessment (HTA). For the outcomes of anxiety and posttraumatic stress (each at 3, 6, and 18 months), suicidal ideation (1, 3, and 18 months), depressive symptoms (1 month), and hopelessness (1 month and 3 months), no hint of (added) benefit of second-wave CBT versus TAU was found. With regard to third-wave CBT, for the outcome of depressive symptoms at the survey time point of 3 months, no hint of (added) benefit of third-wave CBT versus TAU was found. For the outcome of suicidal ideation at the time point of 1 month, no hint of (added) benefit of third-wave CBT versus TAU was found. For the following outcomes, data on second or third-wave CBT were either unavailable or unusable: all-cause mortality / overall survival, suicide mortality, physical functioning including activities of daily living / everyday functioning, inpatient admission, serious adverse events, discontinuation due to adverse events, health-related quality of life, and health-related social functioning, including occupational and social participation. Concerning second-wave CBT, data were also reported on social problem-solving ability, but they were disregarded due to reporting bias. However, patients in the initially conducted discussions highlighted the patient-relevant outcomes listed above as being particularly relevant. Therefore, there is clearly a need for further research, particularly high-quality RCTs, in this area. No studies were found with regard to cost effectiveness, and no conclusion can be drawn on this topic. To generate more evidence in this area as well, future investigations might concurrently collect data on both effectiveness as well as resource use and the costs of the intervention and comparator treatment. The costs listed in the present report are stated as ranges for patients with mild and severe disease courses. They range from EUR188.67 per treatment case for solely drug-based treatment to EUR2684.14 for one-on-one short-term outpatient therapy, and up to EUR15,314.23 for long-term outpatient therapy. However, comparability between the costs of the individual interventions per patient or per patient and treatment case is limited since their separate analyses do not fully reflect the realities of care. Depressive disorders differ widely between individuals in terms of their severity and course; therefore, actual costs might be lower or higher than those presented herein. Interventions other than CBT, including some low-threshold interventions such as telephone counselling or internet-based services, were also mentioned both in the focus groups and in the literature. Due to a lack of studies, however, it was not possible to compare these interventions to TAU. As already concluded by authors of other reviews, future studies should include such interventions as well and determine their effectiveness at early survey time points in order to ensure rapid treatment in crisis situations. The analysis of the ethical, social, legal, and organizational aspects has shown that they are highly relevant to the topic and, in particular, have a major impact on access to measures. Due to the complexity and multidimensional nature of the topic, the individual domains cannot and should not be analysed in isolation. Rather, their mutual interactions should be contemplated and discussed, as illustrated in the logical model.

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 33175482

Resource Allocation and Pandemic Response: An Evidence Synthesis To Inform Decision Making

Resource Allocation and Pandemic Response: An Evidence Synthesis To Inform Decision Making-/-AHRQ Rapid Evidence Products 2020; ():

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 33054151

Predicting Human Health Effects from Environmental Exposures: Applying Translatable and Accessible Biomarkers of Effect: Proceedings of a Workshop-in Brief

Predicting Human Health Effects from Environmental Exposures: Applying Translatable and Accessible Biomarkers of Effect: Proceedings of a Workshop-in Brief-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Biomarkers of effect are measurable changes in an individual that indicate health impairment or disease. Although biomarkers have long been a crucial part of medical practice - blood pressure is a simple example - researchers have recently identified a variety of new biomarkers that signal the presence of conditions such as nervous system damage, autoimmune disorders, and cancer. Of particular interest is the potential of these new biomarkers to measure adverse health effects that may arise from exposure to environmental pollutants. On August 12-13, 2020, the Standing Committee on the Use of Emerging Science for Environmental Health Decisions of the National Academies of Sciences, Engineering, and Medicine held a 2-day workshop to explore how new biomarker approaches can be applied to understanding the consequences of environmental exposures and improve environmental health decisions. The workshop brought together a multidisciplinary group, including experts in public health, environmental health, clinical medicine, and health disparities to discuss the state of the art in biomarkers and health. This Proceedings of a Workshop-in Brief summarizes the workshop presentations and the discussions that took place among the participants.

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 33211454

Racial Justice, Diversity, Equity, and Inclusion in Neuroscience Training: Proceedings of a Workshop-in Brief

Racial Justice, Diversity, Equity, and Inclusion in Neuroscience Training: Proceedings of a Workshop-in Brief-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

The Action Collaborative on Neuroscience Training: Developing a Nimble and Versatile Workforce (Action Collaborative) is an ad hoc activity convened under the auspices of the Forum on Neuroscience and Nervous System Disorders (Neuroscience Forum) of the National Academies of Sciences, Engineering, and Medicine. Originated from and informed by the work of the Action Collaborative, the Neuroscience Forum launched a virtual workshop series in order to explore the rapidly evolving neuroscience career landscape and how neuroscience training programs can help trainees to develop the knowledge and skillset needed to advance their careers and biomedical science. The first of these workshops, held on August 20, 2020, tackled complex issues related to racial justice, diversity, equity, and inclusion. Panel presentations of the workshop were envisioned as a starting point for an ongoing discussion around the ways scientists can stand against racism and support diversity, equity, and inclusion in neuroscience and academia, both in their local communities and in the broader world. This publication highlights the presentations and discussion of the workshop.

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 33136352

Airborne Transmission of SARS-CoV-2: Proceedings of a Workshop-in Brief

Airborne Transmission of SARS-CoV-2: Proceedings of a Workshop-in Brief-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

With the rapidly evolving coronavirus disease 2019 (COVID-19) pandemic, researchers are racing to find answers to critical questions about the virus that causes the disease severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Understanding how the virus is transmitted is among the most important questions, as it will inform efforts to stop its spread. For example, can the virus be transmitted via speech and exhaled breath? How long can aerosols containing the virus linger in the air? How far can these aerosols travel? Is the amount of virus in these aerosols enough to cause infection? These questions and more were the subject of an August 26-27, 2020, National Academies of Sciences, Engineering, and Medicine virtual workshop that convened experts in aerosol science and atmospheric chemistry, building engineering, epidemiology, environmental health, infectious disease, pulmonary medicine, public health, and virology to explore the evidence on airborne transmission of SARS-CoV-2. This publication summarizes the presentations and discussions from the workshop.

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 33119244

Understanding the Well-Being of LGBTQI+ Populations

Understanding the Well-Being of LGBTQI+ Populations-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

The increase in prevalence and visibility of sexually gender diverse (SGD) populations illuminates the need for greater understanding of the ways in which current laws, systems, and programs affect their well-being. Individuals who identify as lesbian, gay, bisexual, asexual, transgender, non-binary, queer, or intersex, as well as those who express same-sex or -gender attractions or behaviors, will have experiences across their life course that differ from those of cisgender and heterosexual individuals. Characteristics such as age, race and ethnicity, and geographic location intersect to play a distinct role in the challenges and opportunities SGD people face. Understanding the Well-Being of LGBTQI+ Populations reviews the available evidence and identifies future research needs related to the well-being of SDG populations across the life course. This report focuses on eight domains of well-being; the effects of various laws and the legal system on SGD populations; the effects of various public policies and structural stigma; community and civic engagement; families and social relationships; education, including school climate and level of attainment; economic experiences (e.g., employment, compensation, and housing); physical and mental health; and health care access and gender-affirming interventions. The recommendations of Understanding the Well-Being of LGBTQI+ Populations aim to identify opportunities to advance understanding of how individuals experience sexuality and gender and how sexual orientation, gender identity, and intersex status affect SGD people over the life course.

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 33104312

No-Touch Modalities for Disinfecting Patient Rooms in Acute Care Settings

No-Touch Modalities for Disinfecting Patient Rooms in Acute Care Settings-/-AHRQ Rapid Evidence Products 2020; ():

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 33074629

Framework for Equitable Allocation of COVID-19 Vaccine

Framework for Equitable Allocation of COVID-19 Vaccine-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.

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 33026758

Reopening U.S. Research Universities: Confronting Long-Standing Challenges and Imagining Novel Solutions: Proceedings of a Workshop-in Brief

Reopening U.S. Research Universities: Confronting Long-Standing Challenges and Imagining Novel Solutions: Proceedings of a Workshop-in Brief-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

On July 21, 2020, the National Academies of Sciences, Engineering, and Medicine's Committee on Science, Engineering, Medicine and Public Policy hosted a virtual workshop, Reopening U.S. Research Universities: Confronting Long-Standing Challenges and Imagining Novel Solutions. Attracting more than 500 participants, the workshop provided an overview of the current situation facing U.S. research universities and explored key questions that the research enterprise must address to build a more effective and resilient 21st century research university. This publication highlights the presentation and discussion of the workshop.

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 33104313

Scanning for New Evidence on the Nutrient Content of Human Milk: A Process Model for Determining Age-Specific Nutrient Requirements

Scanning for New Evidence on the Nutrient Content of Human Milk: A Process Model for Determining Age-Specific Nutrient Requirements-/- 2020; ():

Human milk is considered the biologic norm for feeding the human infant during the first 6 months of life, and it is a preferred food from 6 to 12 months. It is a complex food and exerts its biologic effects well beyond its known nutritional value; however, human milk composition and the complexity of its composition is not wholly known or understood. Thus, defining the composition of milk, as well as both the individual and combined effects of milk components and the volume consumed on infant growth and development, is central to optimizing infant health. Furthermore, defining human milk composition, volume, and the myriad factors that influence milk components is needed for developing future Dietary Reference Intake (DRI) standards for nutrient intakes during the first 12 months of life. Scanning for New Evidence on the Nutrient Content of Human Milk examines the new and emerging evidence describing the nutrient content of human milk as well as the volume of milk consumed, both of which are needed to understand nutrient consumption by healthy breastfed infants. An evidence scan approach was used to summarize the status of the published literature on the nutrient content of human milk and to identify new evidence on nutrients in human milk that could inform the need for a systematic review as a component of the DRI process.

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 33175483

Finding the global in the local: constructing population in the search for disease genes

Global health and the new world order: Historical and anthropological approaches to a changing regime of governance-/-Wellcome Trust-Funded Monographs and Book Chapters 2020; ():

Numerous studies describe the genetic make-up of populations living outside Europe and North America. Many of these tackle human genetic variation with the explicit aim of identifying gene variants of medical significance for the populations studied. However, the chapter points to rather different motivations, showing how recent studies documenting the genetic constitution of non-Western populations have grown out of, and serve the purposes of, efforts to identify genetic factors which influence the health of populations in Europe and North America. Analysing the past thirty-five years of medical research literature, the chapter shows how, in this context, efforts to identify genetic variants of possible significance for disease aetiology have shifted to include large-scale association studies in populations rather than families. It discusses how research with local concerns must nonetheless take into account the global distribution of genes and genotypes, thus making studies of the genetic causes of disease, wherever conducted, increasingly global in their purview. The chapter also argues that this recent knowledge of human population genomics has developed in a way which reinscribes ideas of racial difference into biomedical understanding of human populations, and creates tools for excluding supposedly non-Western populations from research oriented towards the concerns of Western institutions.

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 33226758

Management of Colonic Diverticulitis

Management of Colonic Diverticulitis-/-AHRQ Comparative Effectiveness Reviews 2020; ():

BACKGROUND: There remain uncertainties about the effectiveness and harms of various nonsurgical treatment options for acute diverticulitis, clinical consequences of diagnostic imaging, detection strategies for colorectal cancer (CRC) in patients with recent diverticulitis, and preventive options for long-term recurrence. METHODS: We searched Medline((R)), the Cochrane databases, Embase((R)), CINAHL((R)), and ClinicalTrials.gov from 1990 through June 1, 2020. We included existing systematic reviews (SRs) of computed tomography (CT) test accuracy, randomized controlled trials, adequately adjusted nonrandomized comparative studies for all topics, and larger single-group studies that addressed specific questions. RESULTS: We included 77 primary studies and 2 SRs. With moderate strength of evidence (SoE), CT has high sensitivity (94%) and specificity (99%) to diagnose acute diverticulitis. There is low SoE that CT imaging leads to appropriate management decisions and that misdiagnoses on CT do not result in poor clinical outcomes. Incidental findings on CT may be common (low SoE), but their clinical significance is unclear. There is insufficient evidence about CT test accuracy to stage acute diverticulitis. For patients with uncomplicated acute diverticulitis, there is low SoE that initial outpatient or inpatient management have similar risks of recurrence or elective surgery, but insufficient evidence regarding risk of treatment failure and other outcomes. For patients with uncomplicated acute diverticulitis, there is low SoE that antibiotic treatment does not affect clinically important outcomes. There is insufficient evidence regarding percutaneous drainage to manage complicated acute diverticulitis. There is low SoE that patients with recent acute diverticulitis may be at increased risk of CRC compared with the general population, but that those who undergo colonoscopy soon after acute diverticulitis may ultimately have similar rates of CRC as those who do not. Patients 50 years and older may be at increased risk of CRC (moderate SoE) or premalignant lesions (low to high SoE) compared with younger patients. Colonoscopy after acute diverticulitis rarely results in complications or incomplete procedures (high SoE). The risk of recurrence is not reduced by 5-aminosalicylic acid (5-ASA) (high SoE). The evidence regarding other nonsurgical interventions to prevent recurrence is insufficient. In patients with prior complicated or smoldering/frequently recurrent (after uncomplicated) diverticulitis, elective surgery reduces the risk of diverticulitis recurrence (high SoE), but there is no evidence regarding which patients may benefit most from surgery. CONCLUSION: Important questions about which interventions should be used for which patients remain either unanswered or answered with only low SoE. New high-quality research is needed.

*33164883*
 33164883

Social norms interventions to change clinical behaviour in health workers: a systematic review and meta-analysis

Social norms interventions to change clinical behaviour in health workers: a systematic review and meta-analysis-/-Health Services and Delivery Research 2020; ():

BACKGROUND: A social norms intervention seeks to change the clinical behaviour of a target health worker by exposing them to the values, beliefs, attitudes or behaviours of a reference group or person. These low-cost interventions can be used to encourage health workers to follow recommended professional practice. OBJECTIVE: To summarise evidence on whether or not social norms interventions are effective in encouraging health worker behaviour change, and to identify the most effective social norms interventions. DESIGN: A systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: The following databases were searched on 24 July 2018: Ovid MEDLINE (1946 to week 2 July 2018), EMBASE (1974 to 3 July 2018), Cumulative Index to Nursing and Allied Health Literature (1937 to July 2018), British Nursing Index (2008 to July 2018), ISI Web of Science (1900 to present), PsycINFO (1806 to week 3 July 2018) and Cochrane trials (up to July 2018). PARTICIPANTS: Health workers took part in the study. INTERVENTIONS: Behaviour change interventions based on social norms. OUTCOME MEASURES: Health worker clinical behaviour, for example prescribing (primary outcome), and patient health outcomes, for example blood test results (secondary), converted into a standardised mean difference. METHODS: Titles and abstracts were reviewed against the inclusion criteria to exclude any that were clearly ineligible. Two reviewers independently screened the remaining full texts to identify relevant papers. Two reviewers extracted data independently, coded for behaviour change techniques and assessed quality using the Cochrane risk-of-bias tool. We performed a meta-analysis and presented forest plots, stratified by behaviour change technique. Sources of variation were explored using metaregression and network meta-analysis. RESULTS: A total of 4428 abstracts were screened, 477 full texts were screened and findings were based on 106 studies. Most studies were in primary care or hospitals, targeting prescribing, ordering of tests and communication with patients. The interventions included social comparison (in which information is given on how peers behave) and credible source (which refers to communication from a well-respected person in support of the behaviour). Combined data suggested that interventions that included social norms components were associated with an improvement in health worker behaviour of 0.08 standardised mean differences (95% confidence interval 0.07 to 0.10 standardised mean differences) (n = 100 comparisons), and an improvement in patient outcomes of 0.17 standardised mean differences (95% confidence interval 0.14 to 0.20) (n = 14), on average. Heterogeneity was high, with an overall I(2) of 85.4% (primary) and 91.5% (secondary). Network meta-analysis suggested that three types of social norms intervention were most effective, on average, compared with control: credible source (0.30 standardised mean differences, 95% confidence interval 0.13 to 0.47); social comparison combined with social reward (0.39 standardised mean differences, 95% confidence interval 0.15 to 0.64); and social comparison combined with prompts and cues (0.33 standardised mean differences, 95% confidence interval 0.22 to 0.44). LIMITATIONS: The large number of studies prevented us from requesting additional information from authors. The trials varied in design, context and setting, and we combined different types of outcome to provide an overall summary of evidence, resulting in a very heterogeneous review. CONCLUSIONS: Social norms interventions are an effective method of changing clinical behaviour in a variety of health service contexts. Although the overall result was modest and very variable, there is the potential for social norms interventions to be scaled up to target the behaviour of a large population of health workers and resulting patient outcomes. FUTURE WORK: Development of optimised credible source and social comparison behaviour change interventions, including qualitative research on acceptability and feasibility. STUDY REGISTRATION: This study is registered as PROSPERO CRD42016045718. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 41. See the NIHR Journals Library website for further project information.

*33151653*
 33151653

The effects of interoperable information technology networks on patient safety: a realist synthesis

The effects of interoperable information technology networks on patient safety: a realist synthesis-/-Health Services and Delivery Research 2020; ():

BACKGROUND: Interoperable networks connect information technology systems of different organisations, allowing professionals in one organisation to access patient data held in another one. Health policy-makers in many countries believe that they will improve the co-ordination of services and, hence, the quality of services and patient safety. To the best of our knowledge, there have not been any previous systematic reviews of the effects of these networks on patient safety. OBJECTIVES: The aim of the study was to establish how, why and in what circumstances interoperable information technology networks improved patient safety, failed to do so or increased safety risks. The objectives of the study were to (1) identify programme theories and prioritise theories to review; (2) search systematically for evidence to test the theories; (3) undertake quality appraisal, and use included texts to support, refine or reject programme theories; (4) synthesise the findings; and (5) disseminate the findings to a range of audiences. DESIGN: Realist synthesis, including consultation with stakeholders in nominal groups and semistructured interviews. SETTINGS AND PARTICIPANTS: Following a stakeholder prioritisation process, several domains were reviewed: older people living at home requiring co-ordinated care, at-risk children living at home and medicines reconciliation services for any patients living at home. The effects of networks on services in health economies were also investigated. INTERVENTION: An interoperable network that linked at least two organisations, including a maximum of one hospital, in a city or region. OUTCOMES: Increase, reduction or no change in patients' risks, such as a change in the risk of taking an inappropriate medication. RESULTS: We did not find any detailed accounts of the ways in which interoperable networks are intended to work and improve patient safety. Theory fragments were identified and used to develop programme and mid-range theories. There is good evidence that there are problems with the co-ordination of services in each of the domains studied. The implicit hypothesis about interoperable networks is that they help to solve co-ordination problems, but evidence across the domains showed that professionals found interoperable networks difficult to use. There is insufficient evidence about the effectiveness of interoperable networks to allow us to establish how and why they affect patient safety. LIMITATIONS: The lack of evidence about patient-specific measures of effectiveness meant that we were not able to determine 'what works', nor any variations in what works, when interoperable networks are deployed and used by health and social care professionals. CONCLUSIONS: There is a dearth of evidence about the effects of interoperable networks on patient safety. It is not clear if the networks are associated with safer treatment and care, have no effects or increase clinical risks. FUTURE WORK: Possible future research includes primary studies of the effectiveness of interoperable networks, of economies of scope and scale and, more generally, on the value of information infrastructures. STUDY REGISTRATION: This study is registered as PROSPERO CRD42017073004. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 40. See the NIHR Journals Library website for further project information.

*33146987*
 33146987

The impact of promoting revised UK low-risk drinking guidelines on alcohol consumption: interrupted time series analysis

The impact of promoting revised UK low-risk drinking guidelines on alcohol consumption: interrupted time series analysis-/-Public Health Research 2020; ():

BACKGROUND: The UK's Chief Medical Officers revised the UK alcohol drinking guidelines in 2016 to /= 16 years living in private households in England. INTERVENTIONS: Promotion of revised UK low-risk drinking guidelines. MAIN OUTCOME MEASURES: Primary outcome - alcohol consumption measured by the Alcohol Use Disorders Identification Test - Consumption score. Secondary outcomes - average weekly consumption measured using graduated frequency, monthly alcohol consumption per capita adult (aged >/= 16 years) derived from taxation data, monthly number of hospitalisations for alcohol poisoning (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision: T51.0, T51.1 and T51.9) and assault (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision: X85-Y09), and further measures of influences on behaviour change. DATA SOURCES: The Alcohol Toolkit Study, a monthly cross-sectional survey and NHS Digital's Hospital Episode Statistics. RESULTS: The revised drinking guidelines were not subject to large-scale promotion after the initial January 2016 announcement. An analysis of news reports found that mentions of the guidelines were mostly factual, and spiked during January 2016. In December 2015, the modelled average Alcohol Use Disorders Identification Test - Consumption score was 2.719 out of 12.000 and was decreasing by 0.003 each month. After the January 2016 announcement, Alcohol Use Disorders Identification Test - Consumption scores did not decrease significantly (beta = 0.001, 95% confidence interval -0.079 to 0.099). However, the trend did change significantly such that scores subsequently increased by 0.005 each month (beta = 0.008, 95% confidence interval 0.001 to 0.015). This change is equivalent to 0.5% of the population moving each month from drinking two or three times per week to drinking four or more times per week. Secondary analyses indicated that the change in trend began 6 months before the guideline announcement. The secondary outcome measures showed conflicting results, with no significant changes in consumption measures and no substantial changes in influences on behaviour change, but immediate reductions in hospitalisations of 7.3% for assaults and 15.4% for alcohol poisonings. LIMITATIONS: The pre-intervention data collection period was only 2 months for influences on behaviour change and the graduated frequency measure. Our conclusions may be generalisable only to scenarios in which guidelines are announced but not promoted. CONCLUSIONS: The announcement of revised UK low-risk drinking guidelines was not associated with clearly detectable changes in drinking behaviour. Observed reductions in alcohol-related hospitalisations are unlikely to be attributable to the revised guidelines. Promotion of the guidelines may have been prevented by opposition to the revised guidelines from the government's alcohol industry partners or because reduction in alcohol consumption was not a government priority or because practical obstacles prevented independent public health organisations from promoting the guidelines. Additional barriers to the effectiveness of guidelines may include low public understanding and a need for guidelines to engage more with how drinkers respond to and use them in practice. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15189062. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 14. See the NIHR Journals Library website for further project information.

*33136353*
 33136353

Management and control of tuberculosis control in socially complex groups: a research programme including three RCTs

Management and control of tuberculosis control in socially complex groups: a research programme including three RCTs-/-Programme Grants for Applied Research 2020; ():

BACKGROUND: Socially complex groups, including people experiencing homelessness, prisoners and drug users, have very high levels of tuberculosis, often complicated by late diagnosis and difficulty in adhering to treatment. OBJECTIVE: To assess a series of interventions to improve tuberculosis control in socially complex groups. DESIGN: A series of observational surveys, evaluations and trials of interventions. SETTING: The pan-London Find&Treat service, which supports tuberculosis screening and case management in socially complex groups across London. PARTICIPANTS: Socially complex groups with tuberculosis or at risk of tuberculosis, including people experiencing homelessness, prisoners, drug users and those at high risk of poor adherence to tuberculosis treatment. INTERVENTIONS AND MAIN OUTCOME MEASURES: We screened 491 people in homeless hostels and 511 people in prison for latent tuberculosis infection, human immunodeficiency virus, hepatitis B and hepatitis C. We evaluated an NHS-led prison radiographic screening programme. We conducted a cluster randomised controlled trial (2348 eligible people experiencing homelessness in 46 hostels) of the effectiveness of peer educators (22 hostels) compared with NHS staff (24 hostels) at encouraging the uptake of mobile radiographic screening. We initiated a trial of the use of point-of-care polymerase chain reaction diagnostics to rapidly confirm tuberculosis alongside mobile radiographic screening. We undertook a randomised controlled trial to improve treatment adherence, comparing face-to-face, directly observed treatment with video-observed treatment using a smartphone application. The primary outcome was completion of >/= 80% of scheduled treatment observations over the first 2 months following enrolment. We assessed the cost-effectiveness of latent tuberculosis screening alongside radiographic screening of people experiencing homelessness. The costs of video-observed treatment and directly observed treatment were compared. RESULTS: In the homeless hostels, 16.5% of people experiencing homelessness had latent tuberculosis infection, 1.4% had current hepatitis B infection, 10.4% had hepatitis C infection and 1.0% had human immunodeficiency virus infection. When a quality-adjusted life-year is valued at pound30,000, the latent tuberculosis screening of people experiencing homelessness was cost-effective provided treatment uptake was >/= 25% (for a pound20,000 quality-adjusted life-year threshold, treatment uptake would need to be > 50%). In prison, 12.6% of prisoners had latent tuberculosis infection, 1.9% had current hepatitis B infection, 4.2% had hepatitis C infection and 0.0% had human immunodeficiency virus infection. In both settings, levels of latent tuberculosis infection and blood-borne viruses were higher among injecting drug users. A total of 1484 prisoners were screened using chest radiography over a total of 112 screening days (new prisoner screening coverage was 43%). Twenty-nine radiographs were reported as potentially indicating tuberculosis. One prisoner began, and completed, antituberculosis treatment in prison. In the cluster randomised controlled trial of peer educators to increase screening uptake, the median uptake was 45% in the control arm and 40% in the intervention arm (adjusted risk ratio 0.98, 95% confidence interval 0.80 to 1.20). A rapid diagnostic service was established on the mobile radiographic unit but the trial of rapid diagnostics was abandoned because of recruitment and follow-up difficulties. We randomly assigned 112 patients to video-observed treatment and 114 patients to directly observed treatment. Fifty-eight per cent of those recruited had a history of homelessness, addiction, imprisonment or severe mental health problems. Seventy-eight (70%) of 112 patients on video-observed treatment achieved the primary outcome, compared with 35 (31%) of 114 patients on directly observed treatment (adjusted odds ratio 5.48, 95% confidence interval 3.10 to 9.68; p < 0.0001). Video-observed treatment was superior to directly observed treatment in all demographic and social risk factor subgroups. The cost for 6 months of treatment observation was pound1645 for daily video-observed treatment, pound3420 for directly observed treatment three times per week and pound5700 for directly observed treatment five times per week. LIMITATIONS: Recruitment was lower than anticipated for most of the studies. The peer advocate study may have been contaminated by the fact that the service was already using peer educators to support its work. CONCLUSIONS: There are very high levels of latent tuberculosis infection among prisoners, people experiencing homelessness and drug users. Screening for latent infection in people experiencing homelessness alongside mobile radiographic screening would be cost-effective, providing the uptake of treatment was 25-50%. Despite ring-fenced funding, the NHS was unable to establish static radiographic screening programmes. Although we found no evidence that peer educators were more effective than health-care workers in encouraging the uptake of mobile radiographic screening, there may be wider benefits of including peer educators as part of the Find&Treat team. Utilising polymerase chain reaction-based rapid diagnostic testing on a mobile radiographic unit is feasible. Smartphone-enabled video-observed treatment is more effective and cheaper than directly observed treatment for ensuring that treatment is observed. FUTURE WORK: Trials of video-observed treatment in high-incidence settings are needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17270334 and ISRCTN26184967. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 8, No. 9. See the NIHR Journals Library website for further project information.

*33119243*
 33119243

Seizure first aid training for people with epilepsy attending emergency departments and their significant others: the SAFE intervention and feasibility RCT

Seizure first aid training for people with epilepsy attending emergency departments and their significant others: the SAFE intervention and feasibility RCT-/-Health Services and Delivery Research 2020; ():

BACKGROUND: No seizure first aid training intervention exists for people with epilepsy who regularly attend emergency departments and their significant others, despite such an intervention's potential to reduce clinically unnecessary and costly visits. OBJECTIVES: The objectives were to (1) develop Seizure first Aid training For Epilepsy (SAFE) by adapting a broader intervention and (2) determine the feasibility and optimal design of a definitive randomised controlled trial to test SAFE's efficacy. DESIGN: The study involved (1) the development of an intervention informed by a co-design approach with qualitative feedback and (2) a pilot randomised controlled trial with follow-ups at 3, 6 and 12 months and assessments of treatment fidelity and the cost of SAFE's delivery. SETTING: The setting was (1) third-sector patient support groups and professional health-care organisations and (2) three NHS emergency departments in England. PARTICIPANTS: Participants were (1) people with epilepsy who had visited emergency departments in the prior 2 years, their significant others and emergency department, paramedic, general practice, commissioning, neurology and nursing representatives and (2) people with epilepsy aged >/= 16 years who had been diagnosed for >/= 1 year and who had made two or more emergency department visits in the prior 12 months, and one of their significant others. Emergency departments identified ostensibly eligible people with epilepsy from attendance records and patients confirmed their eligibility. INTERVENTIONS: Participants in the pilot randomised controlled trial were randomly allocated 1 : 1 to SAFE plus treatment as usual or to treatment as usual only. MAIN OUTCOME MEASURES: Consent rate and availability of routine data on emergency department use at 12 months were the main outcome measures. Other measures of interest included eligibility rate, ease with which people with epilepsy could be identified and routine data secured, availability of self-reported emergency department data, self-reported emergency department data's comparability with routine data, SAFE's effect on emergency department use, and emergency department use in the treatment as usual arm, which could be used in sample size calculations. RESULTS: (1) Nine health-care professionals and 23 service users provided feedback that generated an intervention considered to be NHS feasible and well positioned to achieve its purpose. (2) The consent rate was 12.5%, with 53 people with epilepsy and 38 significant others recruited. The eligibility rate was 10.6%. Identifying people with epilepsy from attendance records was resource intensive for emergency department staff. Those recruited felt more stigmatised because of epilepsy than the wider epilepsy population. Routine data on emergency department use at 12 months were secured for 94.1% of people with epilepsy, but the application process took 8.5 months. Self-reported emergency department data were available for 66.7% of people with epilepsy, and people with epilepsy self-reported more emergency department visits than were captured in routine data. Most participants (76.9%) randomised to SAFE received the intervention. The intervention was delivered with high fidelity. No related serious adverse events occurred. Emergency department use at 12 months was lower in the SAFE plus treatment as usual arm than in the treatment as usual only arm, but not significantly so. Calculations indicated that a definitive trial would need approximately 674 people with epilepsy and approximately 39 emergency department sites. LIMITATIONS: Contrary to patient statements on recruitment, routine data secured at the pilot trial's end indicated that approximately 40% may not have satisfied the inclusion criterion of two or more emergency department visits. CONCLUSIONS: An intervention was successfully developed, a pilot randomised controlled trial conducted and outcome data secured for most participants. The consent rate did not satisfy a predetermined 'stop/go' level of >/= 20%. The time that emergency department staff needed to identify eligible people with epilepsy is unlikely to be replicable. A definitive trial is currently not feasible. FUTURE WORK: Research to more easily identify and recruit people from the target population is required. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13871327. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 39. See the NIHR Journals Library website for further project information.

*33112533*
 33112533

Psychosocial support for families of children with neurodisability who have or are considering a gastrostomy: the G-PATH mixed-methods study

Psychosocial support for families of children with neurodisability who have or are considering a gastrostomy: the G-PATH mixed-methods study-/-Health Services and Delivery Research 2020; ():

BACKGROUND: Evidence reviews recommend consistent and structured support for children with neurodisability and their caregivers in care pathways in which professionals recommend a gastrostomy feeding tube. To date, and to our knowledge, no research has shown how these recommendations have been implemented. OBJECTIVES: The objectives were to describe different exemplar models of psychosocial support and provide an estimate of their resources and costs. DESIGN: This was a mixed-methods study involving (1) a web-based survey, (2) a qualitative, collective case study of psychosocial support provision in four services and (3) an estimate of costs and preference through a willingness-to-pay study. SETTING: Four service configurations in different locations in England and Scotland. PARTICIPANTS: Participants were staff who responded to a survey (n = 67) and interviewees (staff, n = 58; parents/children, n = 29). FINDINGS: Psychosocial support was rarely formalised or documented; it was delivered by different members of the multidisciplinary team, rather than by designated staff, and it was often integrated into appointments dominated by clinical care. Parents expressed different needs for support but reported little opportunity to discuss emotional aspects. Psychologists were not routinely involved and, in general, families were underserved by psychosocial services. Professionals constructed families' need for psychosocial support in terms of their own roles and the management of risk. Mechanisms for integrating and delivering support were identified, including models of care that linked community and tertiary health services and integrated health and education through pooled budgets. Although generally valued by both staff and parents, peer-to-peer parent support was not consistently offered. Barriers included concerns about confidentiality and appropriately matching parents. Parents participated as members of a feeding committee at one site. Three analytical constructs described the provision of psychosocial support: 'hidden work', expressing emotional vulnerability and negotiations around risks and values. The cost-of-support study found that there was a mean of 2.25 appointments (n = 8 parents or carers) over the previous 12 months. The cost of health-care professionals' time spent on providing psychosocial support ranged from pound0.00 to pound317.37 per child per year, with an average cost of pound76.42, at 2017 prices. In the willingness-to-pay study the median rank of enhanced support, involving the opportunity to see a psychologist and parental peers, was significantly higher than that of usual care (n = 96 respondents, both carers and professionals, who completed rating of the service; p < 0.001). LIMITATIONS: It proved difficult to disseminate a national survey, which resulted in a small number of returns, and to cost the provision of psychosocial support, which we designated as 'hidden work', owing to the lack of recording in clinical systems. Moreover, estimates were based on small numbers. CONCLUSIONS: Parent interviews and the willingness-to-pay study demonstrated a preference for enhanced psychosocial support. The study suggests that there is a need for services to formally assess families' needs for psychosocial support to ensure that provision is planned, costed and made explicit in care pathways. Personalised interventions may assist with the targeting of resources and ensuring that there is an appropriate balance in focus on both clinical care and psychosocial support needs in relation to and following treatment. FUTURE WORK: More work is needed to develop tools to assess families' needs for psychosocial support and the effectiveness of training packages to strengthen team competency in providing support. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 38. See the NIHR Journals Library website for further project information.

*33048486*
 33048486

Caring for People with Mental Health and Substance Use Disorders in Primary Care Settings: Proceedings of a Workshop

Caring for People with Mental Health and Substance Use Disorders in Primary Care Settings: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Behavioral health conditions, which include mental health and substance use disorders, affect approximately 20 percent of Americans. Of those with a substance use disorder, approximately 60 percent also have a mental health disorder. As many as 80 percent of patients with behavioral health conditions seek treatment in emergency rooms and primary care clinics, and between 60 and 70 percent of them are discharged without receiving behavioral health care services. More than two-thirds of primary care providers report that they are unable to connect patients with behavioral health providers because of a shortage of mental health providers and health insurance barriers. Part of the explanation for the lack of access to care lies in a historical legacy of discrimination and stigma that makes people reluctant to seek help and also led to segregated and inhumane services for those facing mental health and substance use disorders. In an effort to understanding the challenges and opportunities of providing essential components of care for people with mental health and substance use disorders in primary care settings, the National Academies of Sciences, Engineering, and Medicine's Forum on Mental Health and Substance Use Disorders convened three webinars held on June 3, July 29, and August 26, 2020. The webinars addressed efforts to define essential components of care for people with mental health and substance use disorders in the primary care setting for depression, alcohol use disorders, and opioid use disorders; opportunities to build the health care workforce and delivery models that incorporate those essential components of care; and financial incentives and payment structures to support the implementation of those care models, including value-based payment strategies and practice-level incentives. This publication summarizes the presentations and discussion of the webinars.

*33175481*
 33175481

Environmental Neuroscience: Advancing the Understanding of How Chemical Exposures Impact Brain Health and Disease: Proceedings of a Workshop

Environmental Neuroscience: Advancing the Understanding of How Chemical Exposures Impact Brain Health and Disease: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Humans are potentially exposed to more than 80,000 toxic chemicals in the environment, yet their impacts on brain health and disease are not well understood. The sheer number of these chemicals has overwhelmed the ability to determine their individual toxicity, much less potential interactive effects. Early life exposures to chemicals can have permanent consequences for neurodevelopment and for neurodegeneration in later life. Toxic effects resulting from chemical exposure can interact with other risk factors such as prenatal stress, and persistence of some chemicals in the brain over time may result in cumulative toxicity. Because neurodevelopmental and neurodegenerative disorders - such as attention-deficit hyperactivity disorder and Parkinson's disease - cannot be fully explained by genetic risk factors alone, understanding the role of individual environmental chemical exposures is critical. On June 25, 2020, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders hosted a workshop to lay the foundation for future advances in environmental neuroscience. The workshop was designed to explore new opportunities to bridge the gap between what is known about the genetic contribution to brain disorders and what is known, and not known, about the contribution of environmental influences, as well as to discuss what is known about how genetic and environmental factors interact. This publication summarizes the presentation and discussion of the workshop.

*33180402*
 33180402

Understanding and improving experiences of care in hospital for people living with dementia, their carers and staff: three systematic reviews

Understanding and improving experiences of care in hospital for people living with dementia, their carers and staff: three systematic reviews-/-Health Services and Delivery Research 2020; ():

BACKGROUND: Being in hospital can be particularly confusing and challenging not only for people living with dementia, but also for their carers and the staff who care for them. Improving the experience of care for people living with dementia in hospital has been recognised as a priority. OBJECTIVES: To understand the experience of care in hospital for people living with dementia, their carers and the staff who care for them and to assess what we know about improving the experience of care. REVIEW METHODS: We undertook three systematic reviews: (1) the experience of care in hospital, (2) the experience of interventions to improve care in hospital and (3) the effectiveness and cost-effectiveness of interventions to improve the experience of care. Reviews 1 and 2 sought primary qualitative studies and were analysed using meta-ethnography. Review 3 sought comparative studies and economic evaluations of interventions to improve experience of care. An interweaving approach to overarching synthesis was used to integrate the findings across the reviews. DATA SOURCES: Sixteen electronic databases were searched. Forwards and backwards citation chasing, author contact and grey literature searches were undertaken. Screening of title and abstracts and full texts was performed by two reviewers independently. A quality appraisal of all included studies was undertaken. RESULTS: Sixty-three studies (reported in 82 papers) were included in review 1, 14 studies (reported in 16 papers) were included in review 2, and 25 studies (reported in 26 papers) were included in review 3. A synthesis of review 1 studies found that when staff were delivering more person-centred care, people living with dementia, carers and staff all experienced this as better care. The line of argument, which represents the conceptual findings as a whole, was that 'a change of hospital culture is needed before person-centred care can become routine'. From reviews 2 and 3, there was some evidence of improvements in experience of care from activities, staff training, added capacity and inclusion of carers. In consultation with internal and external stakeholders, the findings from the three reviews and overarching synthesis were developed into 12 DEMENTIA CARE pointers for service change: key institutional and environmental practices and processes that could help improve experience of care for people living with dementia in hospital. LIMITATIONS: Few of the studies explored experience from the perspectives of people living with dementia. The measurement of experience of care across the studies was not consistent. Methodological variability and the small number of intervention studies limited the ability to draw conclusions on effectiveness. CONCLUSIONS: The evidence suggests that, to improve the experience of care in hospital for people living with dementia, a transformation of organisational and ward cultures is needed that supports person-centred care and values the status of dementia care. Changes need to cut across hierarchies and training systems to facilitate working patterns and interactions that enable both physical and emotional care of people living with dementia in hospital. Future research needs to identify how such changes can be implemented, and how they can be maintained in the long term. To do this, well-designed controlled studies with improved reporting of methods and intervention details to elevate the quality of available evidence and facilitate comparisons across different interventions are required. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018086013. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 43. See the NIHR Journals Library website for further project information. Additional funding was provided by the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.

*33237687*
 33237687

Understanding the health-care experiences of people with sickle cell disorder transitioning from paediatric to adult services: This Sickle Cell Life, a longitudinal qualitative study

Understanding the health-care experiences of people with sickle cell disorder transitioning from paediatric to adult services: This Sickle Cell Life, a longitudinal qualitative study-/-Health Services and Delivery Research 2020; ():

BACKGROUND: Transitions from paediatric to adult health-care services cause problems worldwide, particularly for young people with long-term conditions. Sickle cell disorder brings particular challenges needing urgent action. OBJECTIVES: Understand health-care transitions of young people with sickle cell disorder and how these interact with broader transitions to adulthood to improve services and support. METHODS: We used a longitudinal design in two English cities. Data collection included 80 qualitative interviews with young people (aged 13-21 years) with sickle cell disorder. We conducted 27 one-off interviews and 53 repeat interviews (i.e. interviews conducted two or three times over 18 months) with 48 participants (30 females and 18 males). We additionally interviewed 10 sickle cell disease specialist health-care providers. We used an inductive approach to analysis and co-produced the study with patients and carers. RESULTS: Key challenges relate to young people's voices being ignored. Participants reported that their knowledge of sickle cell disorder and their own needs are disregarded in hospital settings, in school and by peers. Outside specialist services, health-care staff refuse to recognise patient expertise, reducing patients' say in decisions about their own care, particularly during unplanned care in accident and emergency departments and on general hospital wards. Participants told us that in transitioning to adult care they came to realise that sickle cell disorder is poorly understood by non-specialist health-care providers. As a result, participants said that they lack trust in staff's ability to treat them correctly and that they try to avoid hospital. Participants reported that they try to manage painful episodes at home, knowing that this is risky. Participants described engaging in social silencing (i.e. reluctance to talk about and disclose their condition for fear that others will not listen or will not understand) outside hospital; for instance, they would avoid mentioning cell sickle disorder to explain fatigue. Their self-management tactics include internalising their illness experiences, for instance by concealing pain to protect others from worrying. Participants find that working to stay healthy is difficult to reconcile with developing identities to meet adult life goals. Participants have to engage in relentless self-disciplining when trying to achieve educational goals, yet working hard is incompatible with being a 'good adult patient' because it can be risky for health. Participants reported that they struggle to reconcile these conflicting demands. LIMITATIONS: Our findings are derived from interviews with a group of young people in England and reflect what they told us (influenced by how they perceived us). We do not claim to represent all young people with sickle cell disorder. CONCLUSIONS: Our findings reveal poor care for young people with sickle cell disorder outside specialist services. To improve this, it is vital to engage with young people as experts in their own condition, recognise the legitimacy of their voices and train non-specialist hospital staff in sickle cell disorder care. Young people must be supported both in and outside health-care settings to develop identities that can help them to achieve life goals. FUTURE WORK: Future work should include research into the understanding and perceptions of sickle cell disease among non-specialist health-care staff to inform future training. Whole-school interventions should be developed and evaluated to increase sickle cell disorder awareness. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 44. See the NIHR Journals Library website for further project information.

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 33237686

Clinical Review Report: Vortioxetine Hydrobromide (Trintellix): (Lundbeck Canada Inc.): Indication: The treatment of major depressive disorder in adults

Clinical Review Report: Vortioxetine Hydrobromide (Trintellix): (Lundbeck Canada Inc.): Indication: The treatment of major depressive disorder in adults-/-CADTH Common Drug Reviews 2020; ():

The objective of this report was to perform a systematic review of the beneficial and harmful effects of vortioxetine 5 mg, 10 mg, and 20 mg oral tablets for the treatment of Major depressive disorder in adults.

*33237674*
 33237674

Mini-combined test compared with NICE guidelines for early risk-assessment for pre-eclampsia: the SPREE diagnostic accuracy study

Mini-combined test compared with NICE guidelines for early risk-assessment for pre-eclampsia: the SPREE diagnostic accuracy study-/-Efficacy and Mechanism Evaluation 2020; ():

BACKGROUND: The traditional method of risk assessment for pre-eclampsia recommended by the National Institute for Health and Care Excellence is based on maternal factors and it recommends that high-risk women should be treated with aspirin. An alternative method of screening is based on the competing risk model, which uses Bayes' theorem to combine maternal factors with mean arterial pressure, the uterine artery pulsatility index, serum placental growth factor and pregnancy-associated plasma protein-A at 11-13 weeks' gestation. OBJECTIVE: The primary aim was to compare the performance of screening by risks obtained using the competing risk model with risk assessment using the National Institute for Health and Care Excellence guidelines. DESIGN: This was a prospective multicentre observational study. SETTING: The setting was seven NHS maternity hospitals in England. PARTICIPANTS: Participants were women with singleton pregnancy attending for a routine hospital visit at 11(+0)-13(+6) weeks' gestation between April and December 2016. MAIN OUTCOME MEASURES: The performance of screening for pre-eclampsia by the competing risk model was compared with the National Institute for Health and Care Excellence method. Relative reductions in risk with aspirin prophylaxis of 30% and 60% were assumed for all pre-eclampsia and preterm pre-eclampsia, respectively. The primary comparison was the detection rate of the National Institute for Health and Care Excellence method with the detection rate of a mini-combined test (including maternal factors, mean arterial pressure and pregnancy-associated plasma protein-A) in the prediction of all pre-eclampsia for the same screen-positive rate determined by the National Institute for Health and Care Excellence method. RESULTS: In 473 (2.8%) of the 16,747 pregnancies there was development of pre-eclampsia, including 142 (0.8%) women with preterm pre-eclampsia. The screen-positive rate by the National Institute for Health and Care Excellence method was 10.3%. For all pre-eclampsia, the false-positive and detection rates by the National Institute for Health and Care Excellence method were 9.7% and 31.6%, respectively. For preterm pre-eclampsia, the false-positive and detection rates were 10.0% and 42.8%, respectively. Compliance with the National Institute for Health and Care Excellence recommendation that high-risk women should be treated with aspirin from the first trimester was 23%. For the same screen-positive rate, the detection rate of the mini-combined test for all pre-eclampsia was 42.8%, which was superior to that of the National Institute for Health and Care Excellence method by 11.2% (95% confidence interval 6.9% to 15.6%). The increase in detection for the same screen-positive rate was accompanied by a reduction in false-positive rate of 0.3%. For the same screen-positive rate as National Institute for Health and Care Excellence, the detection rate for preterm pre-eclampsia by combining maternal factors, mean arterial pressure and placental growth factor was 67.3% compared with 44.1% with the National Institute for Health and Care Excellence method. With the addition of the uterine artery pulsatility index, the detection rate was 78.6%. This was higher than that of the National Institute for Health and Care Excellence method by 35.5% (95% confidence interval 25.2% to 45.8%). Calibration of risks for pre-eclampsia was generally good, with the calibration slope very close to 1.0. The feasibility of incorporating a new biomarker was demonstrated. However, the addition of inhibin A to the full combined test did not improve the detection rates for all pre-eclampsia and preterm pre-eclampsia (61% and 80%, respectively). The same screening model for preterm pre-eclampsia by a combination of maternal factors, mean arterial pressure, the uterine artery pulsatility index and placental growth factor achieved detection rates of 45.8% and 56.3%, respectively, for preterm small for gestational age and early small for gestational age neonates. LIMITATION: The study did not include a health economic assessment. CONCLUSION: The findings suggest that performance of screening for pre-eclampsia provided by a combination of maternal factors and biomarkers is superior to that achieved by current National Institute for Health and Care Excellence guidelines. FUTURE WORK: Future work is required to identify potential biomarkers for further improvement of the competing risk model and to carry out a health economic assessment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN83611527. FUNDING: This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 7, No. 8. See the NIHR Journals Library website for further project information.

*33226739*
 33226739

Gabapentin to reduce pain in women aged between 18 and 50 years with chronic pelvic pain: the GaPP2 RCT

Gabapentin to reduce pain in women aged between 18 and 50 years with chronic pelvic pain: the GaPP2 RCT-/-Efficacy and Mechanism Evaluation 2020; ():

BACKGROUND: Chronic pelvic pain affects 2-24% of women worldwide, and evidence for medical treatments is limited. Gabapentin is effective in treating some chronic pain conditions, but its effect on central pain processing is unknown. OBJECTIVES: To test the hypothesis that gabapentin can reduce pain and improve physical and emotional functioning in women with chronic pelvic pain. We investigated the mechanism of action of gabapentin in a subset of women. DESIGN: A randomised, double-blind, placebo-controlled, multicentre trial with a brain imaging substudy. SETTING: This trial took place in 39 UK hospitals. PARTICIPANTS: A target of 300 women with a history of chronic pelvic pain in whom a laparoscopy revealed no obvious pelvic pathology. INTERVENTION: Women were randomised to receive 300 mg of gabapentin (which was escalated to a maximum of 2700 mg daily) or a matched placebo over a 4-week dose-escalation period, followed by 12 weeks on optimal dose. A mechanistic substudy was also undertaken, in which a subset of participants had a functional magnetic resonance imaging scan of their brain before and following 16 weeks of treatment. MAIN OUTCOME MEASURES: The dual primary measure of the worst and average pelvic pain scores was assessed weekly by a numerical rating scale (0-10) in weeks 13-16 post randomisation. The secondary outcomes were patient-reported questionnaires, assessed physical functioning, fatigue, psychological health, sexual activity, work and productivity, and pain catastrophising. Health-care resource use, analgesic use and adverse events were also collected. The main outcome measure for the mechanistic study was brain activity at rest and in response to noxious stimuli. RESULTS: In the main trial, 306 participants were randomised. The mean worst pain score was 7.1 (standard deviation 2.6) in the gabapentin group and 7.4 (standard deviation 2.2) in the placebo group (adjusted mean difference -0.20, 97.5% confidence interval -0.81 to 0.42; p = 0.47). The mean average pain score was 4.3 (standard deviation 2.3) in the gabapentin group and 4.5 (standard deviation 2.2) in the placebo group (adjusted mean difference -0.18, 97.5% confidence interval -0.71 to 0.35; p = 0.45). No significant between-group differences were observed for any secondary outcome. A higher proportion of women experienced a serious adverse event in the gabapentin group than in the placebo group (10/153 vs. 3/153; p = 0.04). Dizziness, drowsiness and visual disturbances were more common in the gabapentin group than in the placebo group. In the mechanistic study, 45 participants had a baseline functional magnetic resonance imaging scan of their brain, with 25 participants returning for a scan at the end of treatment. Gabapentin significantly decreased evoked activity in the anterior cingulate cortex and cuneus. Change in anterior cingulate cortex activity after treatment related to improvement on the pain interference scale, and baseline activation of this region predicted response to treatment. CONCLUSIONS: Gabapentin did not reduce pain and did not improve other outcomes compared with placebo over 16 weeks. Serious adverse effects were significantly higher in the gabapentin group than in the placebo group. Gabapentin reduces evoked activity in the anterior cingulate cortex, with changes of activity in this region tracking reported pain, and baseline activity predicting response to treatment. LIMITATIONS: Primary outcome data were unavailable in 62 and 60 women for the average and worst numerical rating scale pain scores, respectively. A sensitivity analysis using imputation methods did not change the result. FUTURE WORK: Clinical trials to investigate other pharmacological interventions (monotherapy vs. combination therapy), physiotherapy and cognitive-behavioural therapy to treat women with chronic pelvic pain are needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77451762 and EudraCT 2014-005035-13. FUNDING: This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 7, No. 7. See the NIHR Journals Library website for further project information.

*33226738*
 33226738

A duodenal sleeve bypass device added to intensive medical therapy for obesity with type 2 diabetes: a RCT

A duodenal sleeve bypass device added to intensive medical therapy for obesity with type 2 diabetes: a RCT-/-Efficacy and Mechanism Evaluation 2020; ():

BACKGROUND: The EndoBarrier((R)) (GI Dynamics Inc., Boston, MA, USA) is an endoluminal duodenal-jejunal bypass liner developed for the treatment of patients with obesity and type 2 diabetes mellitus. Meta-analyses of its effects on glycaemia and weight have called for larger randomised controlled trials with longer follow-up. OBJECTIVES: The primary objective was to compare intensive medical therapy with a duodenal-jejunal bypass liner with intensive medical therapy without a duodenal-jejunal bypass liner, comparing effectiveness on the metabolic state as defined by the International Diabetes Federation as a glycated haemoglobin level reduction of >/= 20%. The secondary objectives were to compare intensive medical therapy with a duodenal-jejunal bypass liner with intensive medical therapy without a duodenal-jejunal bypass liner, comparing effectiveness on the metabolic state as defined by the International Diabetes Federation as a glycated haemoglobin level of < 42 mmol/mol, blood pressure of < 135/85 mmHg, and the effectiveness on total body weight loss. Additional secondary outcomes were to investigate the cost-effectiveness and mechanism of action of the effect of a duodenal-jejunal bypass liner on brain reward system responses, insulin sensitivity, eating behaviour and metabonomics. DESIGN: A multicentre, open-label, randomised controlled trial. SETTING: Imperial College Healthcare NHS Trust and University Hospital Southampton NHS Foundation Trust. PARTICIPANTS: Patients aged 18-65 years with a body mass index of 30-50 kg/m(2) and with inadequately controlled type 2 diabetes mellitus who were on oral glucose-lowering medications. INTERVENTIONS: Participants were randomised equally to receive intensive medical therapy alongside a duodenal-jejunal bypass liner device (n = 85) or intensive medical therapy alone for 12 months (n = 85), and were followed up for a further 12 months. RESULTS: There was no significant difference between groups in the percentage of patients achieving the glycaemic primary or secondary outcomes [primary outcome at 12 months: duodenal-jejunal bypass liner group 54.5% vs. control group 55.2% (odds ratio 0.93, 95% confidence interval 0.44 to 1.98; p = 0.85); primary outcome at 24 months: duodenal-jejunal bypass liner group 39.7% vs. control group 36.5% (odds ratio 1.13, 95% confidence interval 0.52 to 2.47; p = 0.75)]. Significantly more patients in the duodenal-jejunal bypass liner group than in the control group lost > 15% of their total body weight (duodenal-jejunal bypass liner group 24.2% vs. control group 3.7%; odds ratio 8.33, 95% confidence interval 1.78 to 39.0; p = 0.007) and achieved blood pressure targets (duodenal-jejunal bypass liner group 68.2% vs. control group 44.4%; odds ratio 2.57, 95% confidence interval 1.21 to 5.48; p = 0.014). These differences were observed at 12 months but not at 24 months. There were more adverse events in the duodenal-jejunal bypass liner group, including one liver abscess. The increase in peripheral insulin sensitivity was superior in the duodenal-jejunal bypass liner group. Spectroscopic analyses of plasma, urine and faeces revealed several distinct metabolic perturbations in the duodenal-jejunal bypass liner group but not in the control group. Brain reward responses to food cues were not different between groups. The number of mean quality-adjusted life-years gained was similar in both groups and the additional costs of the duodenal-jejunal bypass liner may outweigh the value of the health benefits by pound2560 per patient treated. CONCLUSIONS: The results show that the endoluminal duodenal-jejunal bypass liner was not superior to intensive medical therapy for glycaemic control and was associated with more adverse events. The duodenal-jejunal bypass liner was associated with significant weight loss and improvement in cardiometabolic parameters at 12 months but not at 24 months. Economic evaluation showed that the bypass liner was not cost-effective for glycaemic control or for weight loss. TRIAL REGISTRATION: Current Controlled Trials ISRCTN30845205. FUNDING: This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 7, No. 6. See the NIHR Journals Library website for further project information. This study was executed with the support of GI Dynamics Inc. and with the kind support of Nutricia Advanced Medical Nutrition for providing oral nutritional supplements.

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 33211455

The transition from children's services to adult services for young people with attention deficit hyperactivity disorder: the CATCh-uS mixed-methods study

The transition from children's services to adult services for young people with attention deficit hyperactivity disorder: the CATCh-uS mixed-methods study-/-Health Services and Delivery Research 2020; ():

BACKGROUND: Attention deficit hyperactivity disorder was previously seen as a childhood developmental disorder, so adult mental health services were not set up to support attention deficit hyperactivity disorder patients who became too old for child services. To our knowledge, this is the first in-depth study of the transition of attention deficit hyperactivity disorder patients from child to adult health services in the UK. OBJECTIVES: Our objectives were to explore how many young people with attention deficit hyperactivity disorder are in need of services as an adult, what adult attention deficit hyperactivity disorder services are available and how attention deficit hyperactivity disorder stakeholders experience transition from child to adult services. DESIGN: An interactive mixed-method design was adopted with three study streams: (1) a 12-month surveillance study with 9-month follow-up to find out how many young people required ongoing medication when they were too old for child services (929 surveys completed by children's clinicians); (2) a mapping study to identify and describe services for young adults with attention deficit hyperactivity disorder (2686 respondents to online surveys for patients and health workers and freedom of information requests to service providers and commissioners); and (3) a qualitative study to explore key stakeholders' experiences of transition from child to adult services (144 interviews with 64 attention deficit hyperactivity disorder patients, 28 parents and 52 health clinicians; 38 working in child or adult secondary health services and 14 general practitioners). Members of the public advised at each stage of the study. RESULTS: When corrected for non-response and case ascertainment, the annual number of young people with an ongoing need for medication for attention deficit hyperactivity disorder lies between 270 and 599 per 100,000 people aged 17-19 years. Among 315 individuals eligible for transition, 64% were accepted, but only 22% attended their first adult services appointment. Our interactive map describes 294 unique services for adults with attention deficit hyperactivity disorder across the UK, of which 44 are 'dedicated' attention deficit hyperactivity disorder services. Few services provide the full range of recommended provision; most focus on diagnosis and medication. Services are unevenly distributed across the UK, with nearly all 'dedicated' services being in England. Exploring stakeholders' experiences revealed how invested the stakeholders are in continuing attention deficit hyperactivity disorder treatment and how the architecture of services affects transition. An association between attention deficit hyperactivity disorder, education and continuance of medication into young adulthood, plus parent involvement and feeling prepared for transition and adult life with attention deficit hyperactivity disorder, influenced investment. However, even with investment, how accessible adult services are, how patient needs fit with the remit of the adult service and the level of patient information available affect transition outcomes. The results also highlight how general practitioners can end up as care co-ordinators during transition by default. LIMITATIONS: Transition estimates were based on those who want medication, so these indicate a minimum level of need. CONCLUSIONS: Few of those who need ongoing support for attention deficit hyperactivity disorder successfully transfer to adult services, and a small proportion of those who transfer experience optimal transitional care. Adult attention deficit hyperactivity disorder service provision is patchy. Even among 'dedicated' services, few provide the whole range of National Institute for Health and Care Excellence-recommended treatments. FUTURE WORK: We need to evaluate various models of transitional care and adult attention deficit hyperactivity disorder provision, as well as develop and evaluate psychosocial interventions for young people and adults with attention deficit hyperactivity disorder. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12492022. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 42. See the NIHR Journals Library website for further project information.

*33211453*
 33211453

Prevention, Diagnosis, and Management of Opioids, Opioid Misuse, and Opioid Use Disorder in Older Adults

Prevention, Diagnosis, and Management of Opioids, Opioid Misuse, and Opioid Use Disorder in Older Adults-/-AHRQ Comparative Effectiveness Technical Briefs 2020; ():

BACKGROUND: Opioid-related harms are increasing among older adults. Until we better understand the factors contributing to this trend, we will be unable to design and implement effective interventions to optimally manage opioid use and its potential harms among older adults. Although considerable research has been done in younger or mixed-age populations, the degree to which it is directly applicable to older adults is uncertain. OBJECTIVES: To provide a framework for understanding how to reduce adverse outcomes of opioid use among older adults, and to describe the evidence available for different factors associated with and interventions to reduce adverse outcomes related to opioid use in this population. APPROACH: With input from a diverse panel of content experts and other stakeholders, we developed a conceptual framework and evidence map to characterize empirical studies of factors associated with opioid-related outcomes and interventions to reduce opioid-related harms in older adults. We identified relevant literature among older adults (age >/=60 years) for an evidence map by systematically searching PubMed, PsycINFO, and CINAHL for studies published in English between 2000 and May 6, 2020. FINDINGS: We identified 5,933 citations, from which we identified 41 studies with multivariable models of factors associated with opioid-related outcomes and 16 studies of interventions in older adults. More than half (22/41) of the multivariable analysis studies evaluated factors associated with long-term opioid use (which, though not a harm per se, may increase the risk of harms if not appropriately managed). Prior or early postoperative opioid use, or greater amounts of prescribed opioids (high number of opioid prescriptions or higher opioid dose), were consistently (100% agreement) and strongly (measure of association >/=2.0) associated with long-term opioid use. Back pain, depression, concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), and fibromyalgia also had consistent, but weaker, associations with long-term opioid use. Several factors were mostly associated (>75% agreement) with long-term opioid use, including benzodiazepine use, comorbidity scores, (generally undefined) substance misuse, tobacco use, and low income. However, studies were mostly consistent that alcohol abuse and healthcare utilization were not associated with long-term opioid use. Gender, age among older adults, Black race, dementia, rural/nonurban residence, prescription of long-acting opioids, unmarried status, and use of muscle relaxants were variably associated (<75% agreement) with long-term opioid use. Six studies examined factors associated with opioid-related disorders, although only one study evaluated factors associated with opioid use disorder. Alcohol misuse and gender were variably associated with opioid misuse (examined by three studies each). All other evaluations of specific pairs of associated factors and outcomes of interest were evaluated by only one or two studies each. These included analyses of factors associated with multiple opioid prescribers, mental health outcomes, physical health outcomes, all-cause hospitalization, opioid-related hospitalization, nonopioid-specific hospitalization, emergency department visits, opioid overdose, all-cause death, opioid-related death, and nonopioid-related death. The evidence on interventions directed at older adults is sparse. Of the 16 studies of opioid-related interventions in older adults, six examined screening tools to predict opioid-related harms, but none of these tools was tested in clinical practice to assess real-world results. Two studies found that prescription drug monitoring programs are associated with less opioid use in communities. Other studied interventions include multidisciplinary pain education for patients, an educational pamphlet for patients, implementation of an opioid safety initiative, provision of patient information and pain management training for clinicians, a bundle of educational modalities for clinicians, free prescription acetaminophen, a nationally mandated tamper-resistant opioid formulation, and motivational interview training for nursing students. Few intervention studies evaluated pain or other patient-centered outcomes such as disability and functioning. CONCLUSIONS: The evidence base that is directly applicable to older adults who are prescribed opioids or have opioid-related disorders is limited. Fundamental research is necessary to determine which factors may predict clinically important, patient-centered, opioid-related outcomes. Studies to date have identified numerous possible factors associated with long-term opioid use (whether appropriate or not), but analyses of other opioid-related outcomes in older adults are relatively sparse. Research is also needed to identify interventions to reduce opioid prescribing where harms outweigh benefits (including screening tools), reduce opioid-related harms and disorders, and treat existing misuse or opioid use disorder among older adults.

*33211447*
 33211447

Roadmap for Narratively Describing Effects of Interventions in Systematic Reviews

Roadmap for Narratively Describing Effects of Interventions in Systematic Reviews-/-AHRQ Methods for Effective Health Care 2020; ():

Accurately describing treatment effects using plain language and narrative statements is a critical step in communicating research findings to end users. However, the process of developing these narratives has not been historically guided by a specific framework. The Agency for Healthcare Research and Quality Evidence-based Practice Center Program developed guidance for narrative summaries of treatment effects that identifies five constructs. We explicitly identify these constructs to facilitate developing narrative statements (1) size of effect, (2) direction of effect, (3) clinical importance, (4) statistical significance, and (5) strength or certainty of evidence. These constructs clearly overlap. It may not always be feasible to address all five constructs. Based on context and intended audience, investigators can assess which constructs will be most important to address in narrative statements.

*33180401*
 33180401

Low-dose intracoronary alteplase during primary percutaneous coronary intervention in patients with acute myocardial infarction: the T-TIME three-arm RCT

Low-dose intracoronary alteplase during primary percutaneous coronary intervention in patients with acute myocardial infarction: the T-TIME three-arm RCT-/-Efficacy and Mechanism Evaluation 2020; ():

BACKGROUND: Microvascular obstruction commonly affects patients with acute ST-segment elevation myocardial infarction and is independently associated with adverse outcomes. OBJECTIVE: To determine whether or not a strategy involving low-dose intracoronary fibrinolytic therapy infused early after coronary reperfusion will reduce microvascular obstruction. DESIGN: This was a multicentre, randomised, double-blind, parallel-group, placebo-controlled, dose-ranging trial. SETTING: The trial took place at 11 hospitals in the UK between 17 March 2016 and 21 December 2017. PARTICIPANTS: Patients with acute ST-segment elevation myocardial infarction and a symptom onset to reperfusion time of

*33175484*
 33175484

Testing a Machine Learning Tool for Facilitating Living Systematic Reviews of Chronic Pain Treatments

Testing a Machine Learning Tool for Facilitating Living Systematic Reviews of Chronic Pain Treatments-/-AHRQ Methods for Effective Health Care 2020; ():

BACKGROUND: Living systematic reviews can more rapidly and efficiently incorporate new evidence into systematic reviews through ongoing updates. A challenge to conducting living systematic reviews is identifying new articles in a timely manner. Optimizing search strategies to identify new studies before they have undergone indexing in electronic databases and automation using machine learning classifiers may increase the efficiency of identifying relevant new studies. METHODS: This project had three stages: develop optimized search strategies (Stage 1), test machine learning classifier on optimized searches (Stage 2), and test machine learning classifier on monthly update searches (Stage 3). Ovid((R)) MEDLINE((R)) search strategies were developed for three previously conducted chronic pain reviews using standard methods, combining National Library of Medicine Medical Subject Headings (MeSH) terms and text words ("standard searches"). Text word-only search strategies ("optimized searches") were also developed based on the inclusion criteria for each review. In Stage 2, a machine learning classifier was trained and refined using citations from each of the completed pain reviews ("training set") and tested on a subset of more recent citations ("simulated update"), to develop models that could predict the relevant of citations for each topic. In Stage 3, the machine learning models were prospectively applied to "optimized" monthly update searches conducted for the three pain reviews. RESULTS: In Stage 1, the optimized searches were less precise than the standard searches (i.e., identified more citations that reviewers eventually excluded) but were highly sensitive. In Stage 2, a machine learning classifier using a support vector machine model achieved 96 to 100 percent recall for all topics, with precision of between 1 and 7 percent. Performance was similar using the training data and on the simulated updates. The machine learning classifier excluded 35 to 65 percent of studies classified as low relevance. In Stage 3, the machine classifier achieved 97 to 100 percent sensitivity and excluded (i.e., classified as very low probability) 45 to 76 percent of studies identified in prospective, actual update searches. The estimated savings in time using the machine classifier ranged from 2.0 to 13.2 hours. CONCLUSIONS: Text word-only searches to facilitate the conduct of living systematic reviews are associated with high sensitivity but reduced precision compared with standard searches using MeSH indexing terms. A machine learning classifier had high recall for identifying studies identified using text word searches, but had low to moderate precision, resulting in a small to moderate estimated time savings when applied to update searches.

*33175480*
 33175480

Innovations in the Food System: Exploring the Future of Food: Proceedings of a Workshop

Innovations in the Food System: Exploring the Future of Food: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

On August 7-8, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, to review the status of current and emerging knowledge about innovations for modern food systems and strategies for meeting future needs. The workshop addressed different perspectives on the topic of food systems and would build on a workshop on the topic of sustainable diets hosted by the Food Forum in August 2018. This publication summarizes the presentations and discussions from the workshop.

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 32379405

Pharmacological Interventions for Chronic Pain in Pediatric Patients: A Review of Guidelines

Pharmacological Interventions for Chronic Pain in Pediatric Patients: A Review of Guidelines-/-CADTH Rapid Response Reports 2020; ():

Chronic pain is defined as recurrent or persistent pain that extends longer than the expected healing time (generally three months or more).(1)(,)(2) Chronic pain affects the individual, as well as the individual's family, society and the health care system.(3) Untreated chronic pain in childhood is associated with risk of subsequent pain as well as physical and psychological impairment in adulthood.(2) A higher proportion of chronic pain in adulthood was reported in those who had chronic pain in adolescence compared with those who were pain free in adolescence.(2) Pathophysiological classifications of chronic pain in the pediatric population include nociceptive pain (somatic or visceral), neuropathic pain (from damage to or dysfunction of the peripheral or central nervous system) and idiopathic pain (no known cause).(4)(,)(5) The most common chronic pain disorders in the pediatric population include primary headache, centrally mediated abdominal pain syndromes, and chronic/recurrent musculoskeletal and joint pain.(2) Globally, pain is a common feature among children and adolescents, and in many it is chronic.(6)(,)(7) A systematic review(8) of studies on the prevalence rates of chronic pain in children and adolescents reported that there was wide variation in the prevalence rates depending on demographics and psychosocial factors; prevalence rates were 8% to 83% for headache, 4% to 53% for abdominal pain, 4% to 40% for musculoskeletal pain, 14% to 24% for back pain, and 5% to 88% for other pain. According to the 2007/2008 Canadian Community Health Survey of individuals in the age group 12 years to 44 years the prevalence of chronic pain was estimated as 9.1% in males and 11.9% in females; for the pediatric subgroup (12 years to 17 years) the prevalence was 2.4% in males and 5.9% in females.(3) The development and persistence of chronic pain involve multiple, integral, neural pain networks (i.e., peripheral, spinal, and brain) that interact in a complex way to contribute to an individual's experience of pain.(8) In children these peripheral, spinal, and brain networks are not mature and change over time as the child matures, which adds further complexity to understanding, evaluating and treating pain in the pediatric population.(8) Pharmacological agents have been used for treatment of chronic non-cancer pain in children and adolescents. These include acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressants, anticonvulsants, and opioids. NSAIDS include agents such as aceclofenac, acetylsalicylic acid, celecoxib, choline magnesium trisalicylates, diclofenac, etodolac, etoricoxib, fenoprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, parecoxib, phenylbutazone, piroxicam, sulindac, tenoxicam, and tiaprofenic acid.(4) Anti-depressants include agents such as amitriptyline, nortriptyline, imipramine, duloxetine, fluoxetine, and bupropion.(9) Anticonvulsants include agents such as gabapentin and pregabalin.(10) Opioids include agents such as buprenorphine, codeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, and tramadol.(7) There appears to be limited evidence available with respect to pharmacological treatments for management of chronic pain in pediatric patients. One systematic review(6) reported that there was no evidence from RCTs to support or refute the use of paracetamol (acetaminophen) for treating chronic non-cancer pain (CNCP) in children and adolescents. A second systematic review(4) investigated the clinical efficacy of NSAIDs for treating CNCP in children and adolescents. The authors reported that there were few RCTs identified and they were of low or very low quality, and they had insufficient data for analysis; hence they were unable to comment on the efficacy or harm of NSAIDs for treating CNCP in children and adolescents. A third systematic review(9) investigated the clinical efficacy of antidepressants for treating CNCP in children and adolescents. The authors reported that there were few RCTs identified and they were of small sample size and of very low quality, and they had insufficient data for analysis; hence they were unable to comment on the efficacy or harm of anti-depressants for treating CNCP in children. A fourth systematic review(7) reported that there was no evidence from RCTs to support or refute the use of opioids for treating CNCP in children and adolescents. There appears to be uncertainty regarding clinical effectiveness pharmacological interventions for treating CNCP in children and adolescents. Hence guidelines regarding the use of pharmacological interventions for treatment of chronic pain is pediatric and young people are important. The aim of this report is to review the evidence-based guidelines regarding pharmacological interventions for pediatric and youth patients with chronic pain.

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 33119240

Building the Workforce We Need to Care for People with Serious Illness: Proceedings of a Workshop

Building the Workforce We Need to Care for People with Serious Illness: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

The United States faces a significantly aging population as well as a growing share of the population that is living longer with multiple chronic conditions. To provide high-quality care to people of all ages living with serious illness, it is critical that the nation develop an adequately trained and prepared workforce consisting of a range of professionals, including physicians, nurses, social workers, direct care workers, and chaplains. To explore some of the key workforce-related challenges to meeting the needs of people with serious illness, the National Academies of Sciences, Engineering, and Medicine hosted a workshop on November 7, 2019. This publication summarizes the presentations and discussions from the workshop.

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 32369317

Ketamine for Chronic Non-Cancer Pain: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

Ketamine for Chronic Non-Cancer Pain: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines-/-CADTH Rapid Response Reports 2020; ():

In Canada, about one in five adults older than 18 years of age live with chronic pain.(1) Pain can be sub-defined by three main biological mechanisms: 1) Nociceptive pain (from damage to body tissue, as in injury, disease or inflammation); 2) Neuropathic pain (from direct damage of the nervous system); and 3) Nociplastic pain (from a change in sensory neurons function).(1) Chronic pain is associated with significant emotional distress, like anxiety, anger, frustration and depression, and is recognized by the World Health Organization as a disease by itself listed in the International Classification of Disease version 11.(1) Treatment and management of chronic pain are complex and difficult, involving multiple interventions, including pharmacological and psychological interventions.(1) Pharmacological interventions considered for chronic pain include nonopioid analgesics (e.g., nonsteroidal anti-inflammatory drugs, acetaminophen), antidepressants, antiepileptic drugs, other adjuvant medications (e.g., topical agents, cannabis and cannabinoids), opioid, and infusion therapies (e.g., ketamine, lidocaine).(2) Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been approved and primarily used as an anesthetic induction agent in doses ranging between 1 and 4.5 mg/kg.(3) As it also interacts with other receptors, ketamine has been explored for other indications such as depressive disorders, suicidal ideation, substance-use disorders, anxiety disorders, refractory status epilepticus, bronchial asthma exacerbations, and pain management.(4) In hospital and emergency department, ketamine has been used for pain management of acute conditions such as burns, trauma, or post-operative pain.(2) Recently, intravenous (IV) ketamine infusions has been increasingly used as a treatment option for acute pain as well as chronic non-cancer pain such as complex regional pain syndrome (CRPS), neuropathic pain, and other refractory chronic pain conditions.(2) Despite potential opportunities of ketamine for numerous indications, the use of ketamine is known to be associated with psychotomimetic effects such as euphoria, dysphoria, psychomotor retardation, hallucinations, vivid dreams, and nightmares, as common side effects. Given the availability of ketamine of different formulations and its potential opportunities in pain management, there is a need to determine its benefits and risks in the treatment of chronic pain. The aim of this report is to review the evidence regarding the clinical effectiveness and cost-effectiveness of ketamine for treating chronic non-cancer pain in adults. This report also aims to review the evidence-based guidelines regarding the use of ketamine for chronic non-cancer pain.

*33231962*
 33231962

Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop

Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Because of the individualized nature of drug and therapeutic treatments, clinical trials require participants who represent the diversity of the patient base. If early trials do not have a broad patient base, it can be difficult to know who may or may not benefit from or respond to a treatment later. In addition to diversity in recruitment, informed consent during participation is also crucial. If participants do not fully understand what they are signing up for, they may become confused, mistrustful, or drop out of a trial altogether, confusing investigators and possibly affecting the generalizability of a study. To explore the incorporation of health literacy practices into clinical trials, the Roundtable on Health Literacy convened a workshop titled Clinical Trials: Practice and Impact on April 11, 2019, in Washington, DC. The workshop presentations and discussion centered around issues related to the challenges or barriers for diverse populations' participation in clinical trials, best practices for clinical trial sites and researchers incorporating health literacy practices, and effective health literacy strategies for clear communication with participants. This publication summarizes the presentation and discussion of the workshop.

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 32484634

Injectable Opioid Agonist Treatment for Patients with Opioid Dependence: A Review of Clinical and Cost-Effectiveness

Injectable Opioid Agonist Treatment for Patients with Opioid Dependence: A Review of Clinical and Cost-Effectiveness-/-CADTH Rapid Response Reports 2020; ():

Opioids have analgesic and central nervous system depressant effects and have been used as medication for pain relief.(1) However, opioids also have the potential to cause euphoria and have been misused, resulting in opioid dependency and consequently increased morbidity and mortality.(1) Opioid dependency is a serious problem and impacts public health with considerable clinical, social and economic implications.(2)(,)(3) The Centers of Disease Control and Prevention estimated that in the US, the economic burden resulting from the misuse of prescription opioids is $78.5 billion per year (which includes costs for health care, productivity loss, treatment for dependency, and criminal justice involvement).(2) In Canada, overdose deaths resulting from opioid dependency are on the rise and are a serious concern. It was estimated that in Canada in 2018, there were at least 4,460 deaths due to opioid overdose and 94% of these were determined to be unintentional overdose; this is a 9.4% increase in overdose deaths from 2017, and 48% increase from 2016.(4) Opioid agonists have the ability to suppress opioid cravings and withdrawal symptoms from acute effects of other opioids, and have been used as a treatment option for opioid dependency. Opioid agonists include drugs such as methadone, buprenorphine, diacetylmorphine (DAM) and hydromorphone (HDM). In some individuals with opioid dependency, even with repeated treatment with oral opioid agonists no benefit was achieved.(4) Injectable opioid agonists have shown some promise in treating opioid dependency in these individuals.(4) Injectable opioid agonists have a rapid onset of action and shorter duration to reach peak values in comparison to oral opioid agonists, and hence there is potential for overdose issues. Administration of injectable opioid agonist under supervision would allow for immediate action to be taken in case of overdose to help ensure safety, although take-home dosing has also been studied.(3)(,)(5) The purpose of this review is to summarize the evidence on the clinical effectiveness and cost-effectiveness of injectable opioid agonist treatment (with DAM or HDM, alone or in combination with methadone or buprenorphine/naloxone), compared with alternative pharmacological treatments or no treatment, for individuals with opioid dependency.

*33231961*
 33231961

Cancer Can concomitant music therapy contribute to better treatment results? IQWiG Reports - Commission No. HT17-02

Cancer Can concomitant music therapy contribute to better treatment results? IQWiG Reports - Commission No. HT17-02-/-Institute for Quality and Efficiency in Health Care: Extracts 2020; ():

RESEARCH QUESTION OF THE HTA REPORT: The aims of this investigation are to - assess the benefit of music therapy (MT) as a therapy accompanying oncological standard therapy by comparing it to no accompanying therapy or other accompanying therapies in adult cancer patients with regard to patient-relevant outcomes, - determine the costs arising from accompanying MT in comparison with a different or no accompanying therapy in adult cancer patients (intervention costs), - assess the cost effectiveness of MT accompanying standard therapy in comparison with no accompanying therapy or other accompanying therapies in adult cancer patients as well as - review ethical, social, legal, and organizational aspects associated with the intervention. CONCLUSION OF THE HTA REPORT: MT as an accompanying therapy in oncology has already been established in the German healthcare system, particularly in the (acute and palliative) inpatient and rehabilitation settings, through service reimbursement as well as its mentions in national guidelines. The present HTA reveals indications and hints of a short-term benefit of MT in comparison with standard care with regard to fatigue, mood swings, anxiety, anxiety & depression, stress/tension, and health-related quality of life as well as, over the course of several sessions, with regard to cancer-related adverse events, fatigue, and mood swings. In comparison with other accompanying therapies (music medicine, mindfulness-based stress reduction), a hint of greater short-term benefit of MT was found with regard to fatigue and subjective well-being. Notably, the available evidence shows a positive effect particularly for comparatively short-term psychological outcomes and, in general, primarily for non-biological outcomes - soon after the intervention. For most biological (clinical) outcomes as well as for persistent psychological conditions such as depression, there is generally a lack of evidence in favour of MT. However, these short-term effects are to be considered in light of the typically precarious, in some cases life-threatening, situation of patients. Furthermore, MT is a non-invasive intervention associated with few ethical concerns and is impossible to conduct without considerable patient motivation and cooperation. The results on the benefit of MT are transferable to Germany if a consistent professional concept and standardized training and/or certification can be assumed to be in place, which is, however, not entirely the case in view of the current lack of regulation. However, a uniform consensus has been reached on the occupational profile as well as (voluntary) certification. Due to differences in reimbursement and local availability, access to MT (in general and in oncology) is not uniformly regulated among inpatient care, the rehabilitation sector, and outpatient care. Due to a lack of data, some questions cannot be answered at this time: No studies were found on the outcomes of coping or activities of daily living, and no study investigating MT as a group intervention was found. Data are insufficient for performing a comparative analysis of the benefit of MT in different cancer entities or for a comparison of curative versus palliative therapy. In the direct comparison with alternative accompanying therapies, MT in the form defined herein was studied in only 3 out of 10 studies, and no studies investigated it in comparison with "sham treatment". No data are available on cost-effectiveness, and estimating the intervention costs is hindered by a lack of data on average treatment duration and frequency of sessions. Only 1 out of the 10 studies was conducted in an outpatient setting. Two ongoing studies on MT from Israel and Germany were found, and their design might potentially produce insights regarding longer-term effects and coping (outcome of "resilience").

*32644324*
 32644324

Exploring the Frontiers of Innovation to Tackle Microbial Threats: Proceedings of a Workshop

Exploring the Frontiers of Innovation to Tackle Microbial Threats: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

On December 4-5, 2019, the National Academies of Sciences, Engineering, and Medicine held a 1.5-day public workshop titled Exploring the Frontiers of Innovation to Tackle Microbial Threats. The workshop participants examined major advances in scientific, technological, and social innovations against microbial threats. Such innovations include diagnostics, vaccines (both development and production), and antimicrobials, as well as nonpharmaceutical interventions and changes in surveillance. This publication summarizes the presentations and discussions from the workshop.

*32790265*
 32790265

Inpatient Diabetes Guideline for Adult Non-Critically Ill Patients

Inpatient Diabetes Guideline for Adult Non-Critically Ill Patients-/-Michigan Medicine Clinical Care Guidelines 2020; ():

This guideline applies to hospitalized adult non-critically ill (non-ICU) patients in general medicine, surgical, perioperative, short-stay, and OB/GYN areas with Type 1 diabetes (T1DM), Type 2 diabetes (T2DM), stress hyperglycemia, diabetes secondary to medications, prediabetes, and gestational diabetes. The objective is to promote safe, effective glycemic management in hospitalized patients targeting blood glucose (BG) to published goals while preventing hypoglycemia. Approximately 30-35% of admitted patients have diabetes. Hyperglycemia is a well-established risk factor for adverse hospital outcomes. Additionally, hypoglycemia can have deleterious consequences. Safe and effective glucose management is of paramount importance in the hospital. Additionally, a hospital admission is an opportune time to address diabetes control.

*32931166*
 32931166

Adalimumab for Adult Patients with Crohn's Disease: A Review of Clinical Effectiveness

Adalimumab for Adult Patients with Crohn's Disease: A Review of Clinical Effectiveness-/-CADTH Rapid Response Reports 2020; ():

In 2018, of the approximate 270,000 Canadians diagnosed with inflammatory bowel disease, 135,000 Canadians were living with Crohn's disease (CD).(1) With a total direct cost of about $1.28 billion in 2018, roughly 42% is allocated to prescription drug use for individuals with inflammatory bowel disease.(2) As an incurable chronic disease with alternating periods of relapse and remission, CD is characterized by symptoms such as weight loss, diarrhea, and abdominal pain.(3) To induce remission, conventional pharmacotherapy (e.g., corticosteroids, purine analogues, methotrexate) can be used.(4) For patients with refractory CD, biologic therapy (e.g., tumour necrosis factor inhibitors [TNFi], non-TNFi biologics) are available.(4) Furthermore, about 75% of individuals suffering from CD will undergo surgical resection at least once.(3) However, postoperative endoscopic and clinical recurrence rates can be as high as 61% after 6 months and 86% after 5 years, respectively.(3) The aforementioned pharmacotherapy options can be used to lengthen the duration of postoperative remission.(3) Nonetheless, uncertainty remains regarding the comparative effectiveness of these pharmacotherapy interventions.(3) Biologics such as TNFi (e.g., adalimumab [ADA], infliximab [IFX]) and non-TNFi (e.g., vedolizumab [VEDO], an anti-integrin) have been shown by randomized placebo controlled trials to be effective for individuals with moderate to severe CD that is refractory to conventional treatment options.(5) Due to the scarcity of head-to-head trials comparing one biologic to another, the choice of first and second-line biologic therapy has been dependent on clinician experience, patient preference, and/or drug coverage.(6) Public and private drug payers have implemented tiered coverage policies as a cost control measure.(7) In cases where there is a lack of evidence that one option is more effective than another, these policies require patients to trial inexpensive alternatives first before applying for special authorization to use a higher cost option.(8) The objective of this report is to review and summarize the relevant literature regarding the clinical effectiveness of ADA versus IFX or VEDO in adult patients with CD.

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 33119242

Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use

Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use-/- 2020; ():

Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medications-medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

*32780578*
 32780578

The Role of Research and Technology in the Changing Ocean Economy: Proceedings of a Workshop-in Brief

The Role of Research and Technology in the Changing Ocean Economy: Proceedings of a Workshop-in Brief-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Oceans have long been a frontier of opportunity for exploration, scientific understanding, commerce, and trade for the United States. The transformative technologies of the fourth industrial revolution - artificial intelligence, machine learning, robotics, Internet of Things, biotechnology, advanced materials - are expected to recondition traditional ocean-based industries and enable the growth of new markets prioritizing sustainability. At the nexus of unprecedented environmental change and rapid technology innovation, how should the United States position itself as a leader in the global ocean economy? On February 4 and 5, 2020, the Government-University-Industry Research Roundtable convened experts to discuss the importance of cross-sector collaboration and the opportunities for U.S. leadership in the context of a changing ocean and a changing ocean economy. This publication highlights the presentation and discussion of the workshop.

*32407044*
 32407044

External Supports for the Treatment of Ankle Sprain: A Review of Clinical Effectiveness

External Supports for the Treatment of Ankle Sprain: A Review of Clinical Effectiveness-/-CADTH Rapid Response Reports 2020; ():

In Canada, 35% of injuries are related to sport or exercise.(1) Ankle injuries (sprain or strain) are among the most common types of injury (51%) presenting to the primary care offices and emergency departments.(1) There are three types of ankle sprain, the location of which is determined by the mechanism of injury: lateral ankle sprain (most common), medial ankle sprain, and syndesmotic sprain (high ankle sprain).(2) Ankle sprain is classified based on clinical signs and functional loss, as follows: grade 1 (mild stretching of a ligament without any instability), grade 2 (more severe injury involving incomplete tear of a ligament with slight instability), and grade 3 (complete tear of a ligament and instability).(2) The immediate goal for treatment of ankle sprain is to reduce pain and swelling. The RICE (rest, ice, compression, elevation) approach has been commonly used in the first two to three days following injury, although evidence on the effectiveness of RICE alone is still lacking.(2) Non-steroidal anti-inflammatory drugs (NSAIDs) can be used to reduce pain. However, the use of NSAIDs may delay the natural healing process due to their inflammatory suppression mechanism.(3) Other modes of non-pharmacological treatment of ankle sprain, depending on the severity of the injury, include immobilization, exercise, manual mobilization, and functional rehabilitation.(2) External ankle supports used in immobilization treatments include bandages, tapes, stockings, and different types of braces.(2) In more severe cases, the ankle is normally immobilized with a plaster cast or splint for a few days.(4) Given the wide variety of types of external ankle supports, there is a need to find out their clinical effectiveness for the treatment of ankle sprain. The aim of this report is to review the evidence regarding the clinical effectiveness of external supports for the treatment of individuals with ankle sprain.

*33112532*
 33112532

Pharmacoeconomic Review Report: Ixekizumab (Taltz): (Eli Lilly Canada Inc.): Indication: For the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to, or are intolerant to conventional therapy

Pharmacoeconomic Review Report: Ixekizumab (Taltz): (Eli Lilly Canada Inc.): Indication: For the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to, or are intolerant to conventional therapy-/-CADTH Common Drug Reviews 2020; ():

Ixekizumab (IXE) (Taltz) is a biologic disease-modifying antirheumatic drug (bDMARD) indicated for use in adult patients with active ankylosing spondylitis (AS) who have responded inadequately to, or are intolerant to conventional therapy (CT). CT may involve corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and conventional disease-modifying antirheumatic drugs (cDMARDs) such as sulfasalazine, methotrexate, and leflunomide1, although according to the latest clinical guideline, corticosteroids should not be used as a long-term treatment for AS, and cDMARDs have not shown efficacy in managing AS and are not recommended to be concurrently administered with biologic treatments. The dosage form of IXE is an 80 mg/mL solution in a pre-filled syringe or pen, intended for patients to self-administer subcutaneously. The recommended dose for adult AS patients is an 80 mg injection given every four weeks. Limited data also suggests that some tumour necrosis factor inhibitor (TNFi)-experienced patients with AS may benefit from a 160 mg starting dose. At the sponsor's submitted price of $1,582.24 per 80 mg dose, the annual cost of IXE is $20,569 in patients with AS, while in patients who started with a 160 mg initial dose, the first-year cost of IXE is $22,151 per patient, followed by $20,569 per patient in subsequent years. IXE was previously reviewed by CADTH in 2016 for the indication of moderate to severe plaque psoriasis, and in 2018 for active psoriatic arthritis in patients with inadequate response to cDMARDs. CADTH Canadian Drug Expert Committee (CDEC) recommended listing IXE for both indications. For moderate to severe plaque psoriasis, CDEC recommended listing with the clinical criteria limiting its use to patients with a documented inadequate response, contraindication, or intolerance to conventional systemic therapies such as methotrexate and cyclosporine, and recommending that treatment should be discontinued if response to treatment with IXE has not been demonstrated after 12 weeks. For active psoriatic arthritis in patients with inadequate response to cDMARDs, CDEC recommended listing with the condition that IXE should provide cost savings for drug plans relative to other biologic treatments reimbursed for the treatment of psoriatic arthritis. The sponsor's submitted price for IXE was $1,519 per 80 mg dose at the time of the 2016 CADTH Common Drug Review (CDR) submission, and $1,544.82 per 80 mg dose at the time of the 2018 CDR submission.

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 33237678

Pharmacoeconomic Review Report: Safinamide (Onstryv): (Valeo Pharma Inc.): Indication: For add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson disease (PD) in patients experiencing "OFF" episodes while on a stable dose of levodopa. Safinamide has not been shown to be effective as monotherapy for the treatment of PD

Pharmacoeconomic Review Report: Safinamide (Onstryv): (Valeo Pharma Inc.): Indication: For add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson disease (PD) in patients experiencing "OFF" episodes while on a stable dose of levodopa. Safinamide has not been shown to be effective as monotherapy for the treatment of PD-/-CADTH Common Drug Reviews 2020; ():

Safinamide mesylate is a monoamine oxidase B (MAO-B) inhibitor used as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson disease (PD) in patients experiencing OFF episodes while on a stable dose of levodopa. It is available as 50 mg and 100 mg tablets at a submitted price of $6.90 per tablet, regardless of strength. The recommended starting dose of safinamide is 50 mg daily, which may be increased to 100 mg daily after two weeks based on clinical need and tolerability. The sponsor submitted a cost-utility analysis comparing safinamide 100 mg with multiple comparators that included MAO-B inhibitors (rasagiline, selegiline), catechol -Omethyltransferase inhibitors (entacapone), and dopamine agonists (bromocriptine, pramipexole, ropinirole, rotigotine) as adjunct therapies to levodopa. The sponsor's base case was a probabilistic analysis conducted from the perspective of a Canadian publicly funded health care payer over a 10-year time horizon, with costs and benefits discounted at a rate of 1.5% per annum. The model consisted of 18 mutually exclusive health states: 16 base health states were based on four categories of waking time spent in an OFF state applied to four Hoehn and Yahr (H&Y) stages (stages 2 to 5) and the remaining two health states were discontinuation due to adverse events (AEs) followed by a treatment switch, and death.

*33231958*
 33231958

Clinical Review Report: Safinamide (Onstryv): (Valeo Pharma Inc.): Indication: For add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson disease (PD) in patients experiencing "off" episodes while on a stable dose of levodopa. Safinamide has not been shown to be effective as monotherapy for the treatment of PD

Clinical Review Report: Safinamide (Onstryv): (Valeo Pharma Inc.): Indication: For add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson disease (PD) in patients experiencing "off" episodes while on a stable dose of levodopa. Safinamide has not been shown to be effective as monotherapy for the treatment of PD-/-CADTH Common Drug Reviews 2020; ():

The objective of this report was to perform a systematic review of the beneficial and harmful effects of safinamide oral tablets, 50 mg or 100 mg, as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson disease in patients experiencing OFF episodes while on a stable dose of levodopa.

*33231957*
 33231957

Clinical Review Report: Iron Isomaltoside 1000 (Monoferric): (Pharmacosmos A/S): Indication: For the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy

Clinical Review Report: Iron Isomaltoside 1000 (Monoferric): (Pharmacosmos A/S): Indication: For the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy-/-CADTH Common Drug Reviews 2020; ():

The objective of this review was to perform a systematic review of the beneficial and harmful effects of iron isomaltoside 1000 injection (100 mg elemental iron/mL) for the treatment of iron deficiency anemia in adults (>/= 18 years of age) who have an intolerance or unresponsiveness to oral iron.

*33231956*
 33231956

Pharmacoeconomic Review Report: Iron Isomaltoside 1000 (Monoferric): (Pharmacosmos A/S): Indication: For the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy

Pharmacoeconomic Review Report: Iron Isomaltoside 1000 (Monoferric): (Pharmacosmos A/S): Indication: For the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy-/-CADTH Common Drug Reviews 2020; ():

Iron isomaltoside 1000 (Monoferric), also known as ferric derisomaltose, consists of iron and isomaltoside, a carbohydrate, forming a matrix structure designed for the controlled release of iron in the body. Iron isomaltoside 1000 is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance or unresponsiveness to oral iron therapy. The diagnosis must be based on laboratory tests. It is available as 100 mg/mL of elemental iron in 1 mL, 5 mL, and 10 mL vial sizes, at submitted prices of $45, $225, and $450, respectively, or $45 per mL. Iron isomaltoside 1000 can be dosed in one of two ways: first, by using the Ganzoni formula, accounting for individual patient weight, assumed iron stores, and target and actual hemoglobin (Hb) levels; or, second, according to a simplified dosing table leading to doses of 1,000 mg, 1,500 mg, or 2,000 mg (see Table 4). As a bolus injection, up to 500 mg of iron isomaltoside 1000 may be administered up to once weekly at a rate of 250 mg per minute. As an infusion, if the cumulative required iron dose exceeds 20 mg iron/kg body weight, the dose should be split into two administrations given at least a week apart. Single doses above 1,500 mg are not recommended. Using the simplified table, the drug acquisition cost per course of therapy is $450 to $900. The sponsor submitted a cost-utility analysis (CUA) comparing iron isomaltoside 1000 to iron sucrose (Venofer) for adults with IDA who have intolerance or unresponsiveness to oral iron therapy, from the perspective of a Canadian publicly funded health care system over a six-month time horizon. Patients entered the model in the IDA health state and, at the end of the first week, transitioned into either a responder or a nonresponder health state. Patients could become responders during any of the first five weeks. The efficacy of iron sucrose, in terms of the proportion of patients who had responded to treatment in each of the first five weeks of the model, was based on the percentage of patients with an Hb increase of 2 g/dL or more in the iron sucrose group of the PROVIDE trial. Relative response in the iron isomaltoside 1000 group was estimated using a hazard ratio (HR) of 2.488 over the first five weeks as reported in PROVIDE. The utility values for patients in the responder health state was assumed to be 0.863, the average Canadian utility value. Nonresponders were assigned a utility of 0.713, based on a disutility of 0.15 reported in US patients with anemia. From week 6 onward, all patients in 1,000 mg and 200 mg for iron isomaltoside 1000 and iron sucrose, respectively). Additional costs included those associated with drug administration. The sponsor reported that iron isomaltoside 1000 was associated with cost savings of $570 compared to iron sucrose and 0.0026 additional quality-adjusted life-years (QALYs). Iron isomaltoside 1000 was dominant over iron sucrose.

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 33211445

Clinical Review Report: Sodium Zirconium Cyclosilicate (Lokelma): (AstraZeneca Canada Inc.): Indication: For the treatment of hyperkalemia in adults

Clinical Review Report: Sodium Zirconium Cyclosilicate (Lokelma): (AstraZeneca Canada Inc.): Indication: For the treatment of hyperkalemia in adults-/-CADTH Common Drug Reviews 2020; ():

The objective of this report was to perform a systematic review of the beneficial and harmful effects of Sodium zirconium cyclosilicate 5 g and 10 g powder for oral suspension to treat hyperkalemia in adults.

*33151652*
 33151652

Pharmacoeconomic Review Report: Sodium Zirconium Cyclosilicate (Lokelma): (AstraZeneca Canada Inc.): Indication: For the treatment of hyperkalemia in adult patients.

Pharmacoeconomic Review Report: Sodium Zirconium Cyclosilicate (Lokelma): (AstraZeneca Canada Inc.): Indication: For the treatment of hyperkalemia in adult patients.-/-CADTH Common Drug Reviews 2020; ():

Sodium zirconium cyclosilicate (SZC) (Lokelma) is a non-absorbed, non-polymer inorganic powder with a uniform micropore structure that preferentially captures potassium in exchange for hydrogen and sodium cations. It is indicated for the treatment of hyperkalemia in adult patients. The recommended starting dose for patients whose serum potassium level is > 5.0 mmol/L (correction phase) is 10 g administered three times a day as an oral suspension (in water) for up to two days. For continued maintenance treatment, a dose of 5 g daily is recommended, with possible titration up to 10 g once daily or down to 5 g once every other day, as needed. No more than 10 g daily should be used for maintenance therapy. The sponsor submitted a price for SZC of $12.50 per 5 g and $25.00 per 10 g sachet. At the recommended dose of 10 g three times a day during the correction phase, SZC costs $75 daily. The average annual cost of SZC for maintenance treatment ranges from $2,283 to $9,131 per patient ($6.25 to $25 daily). The sponsor submitted a cost-utility analysis comparing SZC with best supportive care (BSC), which included the intermittent use of sodium polystyrene sulfonate (SPS) or calcium polystyrene sulfonate (CPS) for the correction of serum potassium levels as well as lifestyle interventions for the maintenance of serum potassium levels. The sponsor considered two distinct populations in its economic evaluation: 1) adult patients with hyperkalemia who require corrective treatment; and, 2) adult patients requiring maintenance treatment who have chronic kidney disease (CKD), an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73m(2), a history of at least two hyperkalemia events, and who are required to be suboptimally managed on renin-angiotensin-aldosterone system inhibitor (RAASi) therapies. The primary analysis reflected a population of adult patients with hyperkalemia and an underlying condition of advanced CKD and/or heart failure (HF), with scenario analyses focusing on a CKD-only and an HF-only population. The sponsor's base-case model was conducted from the perspective of the Canadian publicly funded health care payer over a lifetime horizon (up to a maximum age of 100 years). Future costs and benefits were discounted at 1.5% per annum. In the model, patients transition between HF and CKD states. They may also experience worsening of kidney function, transition to end-stage renal disease, and initiate renal replacement therapy (RRT). Patients were assumed to experience a hyperkalemia event when their serum potassium levels exceeded a defined threshold (5.5 mmol/L). Major adverse cardiac events (MACEs), hospitalization, changes in RAASi use, and mortality were dependent on serum potassium levels. The sponsor assumed that patients who started treatment on SZC would move on to BSC if they discontinued their initial treatment. Reinitiation was allowed after the first 28-day period and prior to RRT initiation. Both CKD and HF progression were based on the literature, and a mixed-effects regression model based on clinical trial data was used to inform treatment-specific serum potassium profiles. Utility values were obtained from the literature. The sponsor reported that SZC was associated with both more costs (increases of $663 for acute correction and $28,719 for maintenance) and quality-adjusted life-years (QALYs) than BSC (0.008 more QALYs for acute correction and 0.343 more QALYs for maintenance). The resulting incremental cost-effectiveness ratios (ICERs) were $82,067 per QALY for acute correction and $83,693 per QALY for maintenance.

*33151650*
 33151650

Consciousness and Morality

Oxford Handbook of the Philosophy of Consciousness-/-Wellcome Trust-Funded Monographs and Book Chapters 2020; ():

It is well known that the nature of consciousness is elusive, and that attempts to understand it generate problems in metaphysics, philosophy of mind, psychology, and neuroscience. Less appreciated are the important - even if still elusive - connections between consciousness and issues in ethics. In this chapter we consider three such connections. First, we consider the relevance of consciousness for questions surrounding an entity's moral status. Second, we consider the relevance of consciousness for questions surrounding moral responsibility for action. Third, we consider the relevance of consciousness for the acquisition of moral knowledge.

*33136355*
 33136355

Agentive Phenomenology

Oxford Handbook of the Philosophy of Consciousness-/-Wellcome Trust-Funded Monographs and Book Chapters 2020; ():

In this chapter we reflect on questions about the nature and sources of agentive phenomenology - that is, the set of those experience-types associated with exercises of agency, and paradigmatically with intentional actions. Our discussion begins with pioneering work in psychology and neuroscience that dates to the early 80s (section 1). As we will see, much of the current work on agentive phenomenology in both psychology and philosophy draws motivation from this work, and the questions it raises. After discussing empirical work relevant to agentive phenomenology, we turn to consideration of its nature. We cover questions about the scope of agentive phenomenology, about its relationship to other types of experiences (section 2.1), about the best way to characterize aspects of agentive phenomenology, and about the function of various types of agentive experience (section 2.2).

*33136354*
 33136354

Person-Centered, Outcomes-Driven Treatment: A New Paradigm for Type 2 Diabetes in Primary Care

Person-Centered, Outcomes-Driven Treatment: A New Paradigm for Type 2 Diabetes in Primary Care-/- 2020; ():

Primary care providers are well-positioned to help patients with type 2 diabetes achieve glycemic control while reducing their risks of serious complications such as atherosclerotic cardiovascular disease, heart failure, and chronic kidney disease. Recent outcomes trials of glucagon-like peptide 1 receptor agonists and sodium- glucose cotransporter 2 inhibitors have revealed that these agents offer cardiorenal benefits beyond their glucose-lowering effects. The American Diabetes Association and the European Association for the Study of Diabetes now recommend a person-centered approach to type 2 diabetes treatment through which a patient's multimorbidities, preferences, characteristics, and barriers are considered alongside A1C in individualizing the diabetes management plan. Here, we review the evidence supporting this guidance and describe how to implement the new holistic approach. Research has demonstrated the potential for offering a continuum of benefit from primary through tertiary prevention of microvascular and macrovascular disease while also achieving glycemic targets. The new outcomes-based guidelines provide a roadmap for integrating this newfound knowledge into clinical practice.

*32667763*
 32667763

Exploring Greek Manuscripts in the Library at Wellcome Collection in London

Exploring Greek Manuscripts in the Library at Wellcome Collection in London-/-Wellcome Trust-Funded Monographs and Book Chapters 2020; ():

This book offers new insights into a largely understudied group of Greek texts preserved in selected manuscripts from the Library at Wellcome Collection, London. The content of these manuscripts ranges from medicine, including theories on diagnosis and treatment of disease, to astronomy, philosophy, and poetry. With texts dating from the ancient era to the Byzantine and Ottoman worlds, each manuscript provides its own unique story, opening a window onto different social and cultural milieus. All chapters are illustrated with black and white and colour figures, highlighting some of the most significant codices in the collection.

*32603038*
 32603038

Management of Periodontal Disease

Management of Periodontal Disease-/-New York State Department of Health AIDS Institute Clinical Guidelines 2020; ():

*32598107*
 32598107

Interventions to Prevent Illicit and Nonmedical Drug Use in Children, Adolescents, and Young Adults: Updated Systematic Evidence Review for the U.S. Preventive Services Task Force

Interventions to Prevent Illicit and Nonmedical Drug Use in Children, Adolescents, and Young Adults: Updated Systematic Evidence Review for the U.S. Preventive Services Task Force-/-U.S. Preventive Services Task Force Evidence Syntheses, formerly Systematic Evidence Reviews 2020; ():

IMPORTANCE: Illicit and nonmedical drug use is common in adolescents and young adults, and increases the risk of injury, death, and other harmful outcomes. OBJECTIVE: To systematically review the benefits and harms of primary care-relevant interventions to prevent illicit and nonmedical drug use in children, adolescents, and young adults to inform the United States Preventive Services Task Force. DATA SOURCES: MEDLINE, PubMED, PsycINFO, and the Cochrane Central Register of Controlled Trials; references of relevant publications, government Web sites. STUDY SELECTION: English-language randomized and nonrandomized clinical trials of behavioral counseling interventions to prevent illicit and nonmedical drug use among young people with no history of regular or problematic illicit drug use. DATA EXTRACTION AND SYNTHESIS: Two investigators independently reviewed abstracts and full-text articles, then we extracted data from studies rated as fair- and good-quality, based on predetermined criteria. We extracted illicit drug use outcomes as well as health, social, legal, other behavioral (e.g., use of other substances, other risky behaviors), and harms-related outcomes. Random-effects meta-analysis was used to estimate the benefits of the interventions. Strength-of-evidence ratings were made based on consistency, precision, study quality, and evidence of reporting bias, taking into account the size of the evidence base and other noted limitations. RESULTS: We identified 29 trials (N=18,353) that met our inclusion criteria. Twenty-six of the trials focused on nonpregnant youth covering ages 10 through 24 years, collectively, and are referred to as "general prevention" trials. Health outcomes were reported in 16 of the general prevention trials, but no single outcome was widely reported and most showed no group differences. Some of the general prevention interventions reduced illicit and nonmedical drug use; however, results were inconsistent across the body of literature and the pooled effect did not show a statistically significant association with illicit drug use (pooled SMD=-0.08 [95% CI, -0.16 to 0.001], k=24 [from 23 studies], n=12,801, I(2)=57.0%), pooling a wide range of outcomes (e.g., any use, frequency of use, score on a continuous use scale). Among 26 general prevention trials reporting any use of either cannabis or all drugs, the absolute percent of participants using illicit drugs ranged from 2.3 to 38.6 percent in the control groups and 2.4 to 33.7 percent in the intervention groups at followup ranging from 3 to 32 months, and the median absolute risk difference between groups was -2.8 percent, favoring the intervention group (range, -11.5% to +14.8%). When examining the change in total number of times illicit drugs were used in the previous 3 months, the pooled mean difference between groups was -0.21 times (95% CI, -0.44 to 0.02, k=11, n=3651, I(2)=51.0%). The remaining three trials provided an intensive, multitarget, perinatal home-visiting intervention to pregnant Native American youth (Family Spirit intervention). Only one of the Family Spirit trials (the largest, best-quality of the three) found a reduction in depression, externalizing behaviors, and illicit drug use, only at the last (38-month) followup for most outcomes. Across all 29 trials, only one trial reported on harms, a Family Spirit trial, and found no group differences, after controlling for contact time. Two general prevention trials reported statistically significantly higher illicit drug use in the intervention group at followup. LIMITATIONS: Health outcomes were sparsely reported, and drug-related outcomes were very heterogeneous, including any illicit use, frequency of use, and use scores for either cannabis only or all illicit drugs combined. We did not include general prevention interventions that did not appear to have drug-specific content and that did not report illicit drug use outcomes. This led to the exclusion of programs including children younger than the age of 10, since trials in young children did not target drug use specifically and typically reported behavioral and academic outcomes rather than illicit drug use outcomes. CONCLUSIONS: We found low strength of evidence on the benefits of behavioral counseling interventions to prevent illicit and nonmedical substance use in young people due to inconsistency and imprecision of findings. Health, social, and legal outcomes were sparsely reported and few showed improvement. Some interventions were associated with reductions in illicit and nonmedical drug use; however, others showed no benefit and two found paradoxical increases in use.

*32515916*
 32515916

Multisystemic therapy compared with management as usual for adolescents at risk of offending: the START II RCT

Multisystemic therapy compared with management as usual for adolescents at risk of offending: the START II RCT-/-Health Services and Delivery Research 2020; ():

BACKGROUND: The Systemic Therapy for At Risk Teens (START) trial is a randomised controlled trial of multisystemic therapy (MST) compared with management as usual (MAU). The present study reports on long-term follow-up of the trial (to 60 months). OBJECTIVES: The primary objective was to compare MST and MAU for the proportion of young people in each group with criminal convictions up to 60 months post baseline. Secondary outcomes included group comparisons of psychological and behavioural factors. An economic analysis was carried out to determine the cost-effectiveness of MST compared with MAU. Two qualitative studies were conducted to better understand the subjective experiences of the participants. DESIGN: Primary outcomes (collected up to 60 months) were collected using a centralised police database. Secondary outcomes were evaluated using self-report questionnaires completed by both young people and parents or carers at the 24-, 36- and 48-month follow-ups. Research assistants were blind to treatment allocation. SETTING: Participants were recruited from participating MST sites in nine areas of England. Secondary outcomes were typically collected within the family home. PARTICIPANTS: A total of 684 families were recruited into the START trial and allocated randomly to a treatment group. Of these, 487 remained in the second phase of the trial. Young people were aged, on average, 13.8 years at baseline, with 63% male and 37% female. INTERVENTIONS: MST is a manualised programme for young people exhibiting antisocial behaviour and their families that uses principles from cognitive-behavioural and family therapy to provide an individualised approach. MAU content was not prespecified, but consisted of the standard care offered to young people who met eligibility for the trial. MAIN OUTCOME MEASURES: Young people's offending was evaluated using the Police National Computer. Secondary measures included validated self-report measures completed by both the young person and their parent or carer. The economic evaluation took a broad perspective and outcomes were assessed in terms of quality-adjusted life-years and offending. RESULTS: No significant differences were found in the proportion of offending between the groups (hazard ratio 1.03, 95% confidence interval 0.84 to 1.26; p = 0.78). No differences were found between the groups on secondary outcome measures, with a few exceptions that did not hold up consistently across the follow-up period. The economic analysis did not find evidence to support the cost-effectiveness of MST compared with MAU. Outcomes from the qualitative studies suggest that families mostly felt positive about MST, and that MST was associated with greater maturity in young men. LIMITATIONS: Some intended evaluations were not possible to deliver. Selective attrition may have influenced the nature of the sample size. It is also unclear how representative the MAU services were of reality. FUTURE RESEARCH: Recommendations are made for the evaluation of MST in populations with more severe behavioural problems, as well as for identifying and testing new moderators. CONCLUSIONS: The results of the second phase of the START trial do not support the long-term superiority of MST to MAU, but elements of the intervention may be adapted successfully. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77132214 and London South-East REC registration number 09/H1102/55. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 23. See the NIHR Journals Library website for further project information.

*32484635*
 32484635

The Evidence Base for Telehealth: Reassurance in the Face of Rapid Expansion During the COVID-19 Pandemic

The Evidence Base for Telehealth: Reassurance in the Face of Rapid Expansion During the COVID-19 Pandemic-/-AHRQ Methods for Effective Health Care 2020; ():

With funding from the AHRQ Effective Health Care Program, the Pacific Northwest Evidence-based Practice Center produced two reports on telehealth: (1) in 2016 an evidence mapon the impact of telehealth on patient outcomes7 and (2) in 2019 a systematic review of the evidence about telehealth for acute- and chronic-care consultations.(8) In this commentary, we summarize evidence on selected topics from these reports that may be relevant in the context of the response to the COVID-19 pandemic.

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 32479040

Interventions for Substance Use Disorders in Adolescents: A Systematic Review

Interventions for Substance Use Disorders in Adolescents: A Systematic Review-/-AHRQ Comparative Effectiveness Reviews 2020; ():

OBJECTIVES: This systematic review (SR) synthesizes the literature on behavioral, pharmacologic, and combined interventions for adolescents ages 12 to 20 years with problematic substance use or substance use disorder. We included interventions designed to achieve abstinence, reduce use quantity and frequency, improve functional outcomes, and reduce substance-related harms. DATA SOURCES: We conducted literature searches in MEDLINE, the Cochrane CENTRAL Trials Registry, Embase, CINAHL, and PsycINFO to identify primary studies meeting eligibility criteria through November 1, 2019. REVIEW METHODS: Studies were extracted into the Systematic Review Data Repository. We categorized interventions into seven primary intervention components: motivational interviewing (MI), family focused therapy (Fam), cognitive behavioral therapy (CBT), psychoeducation, contingency management (CM), peer group therapy, and intensive case management. We conducted meta-analyses of comparative studies and evaluated the strength of evidence (SoE). The PROSPERO protocol registration number is CRD42018115388. RESULTS: The literature search yielded 33,272 citations, of which 118 studies were included. Motivational interviewing reduced heavy alcohol use days by 0.7 days/month, alcohol use days by 1.2 days/month, and overall substance use problems by a standardized mean difference of 0.5, compared with treatment as usual. Brief MI did not reduce cannabis use days (net mean difference of 0). Across multiple intensive interventions, Fam was most effective, reducing alcohol use days by 3.5 days/month compared with treatment as usual. No intensive interventions reduced cannabis use days. Pharmacologic treatment of opioid use disorder led to a more than 4 times greater likelihood of abstinence with extended courses (2 to 3 months) of buprenorphine compared to short courses (14 to 28 days). CONCLUSIONS: Brief interventions: MI reduces heavy alcohol use (low SoE), alcohol use days (moderate SoE), and substance use-related problems (low SoE) but does not reduce cannabis use days (moderate SoE). Nonbrief interventions: Fam may be most effective in reducing alcohol use (low SoE). More research is needed to identify other effective intensive behavioral interventions for alcohol use disorder. Intensive interventions did not appear to decrease cannabis use (low SoE). Some interventions (CBT, CBT+MI, and CBT+MI+CM) were associated with increased cannabis use (low SoE). Both MI and CBT reduce combined alcohol and other drug use (low SoE). Combined CBT+MI reduces illicit drug use (low SoE). Subgroup analyses of interest (male vs. female, racial and ethnic minorities, socioeconomic status, and family characteristics) were sparse, precluding conclusions regarding differential effects. Pharmacological interventions: longer courses of buprenorphine (2-3 months) are more effective than shorter courses (14-28 days) to reduce opioid use and achieve abstinence (low SoE). SRs in the college settings support use of brief interventions for students with any use, heavy or problematic use. More research is needed to identify the most effective combinations of behavioral and pharmacologic treatments for opioid, alcohol, and cannabis use disorders.

*32479039*
 32479039

Labor Dystocia

Labor Dystocia-/-AHRQ Comparative Effectiveness Reviews 2020; ():

OBJECTIVES: This review evaluates the comparative effectiveness of different strategies for treating labor dystocia in women with otherwise uncomplicated pregnancies. DATA SOURCES: We searched PubMed((R)), Embase((R)), CINAHL((R)), and the Cochrane Database of Systematic Reviews (CDSR), limiting the searches to studies in the English language and comparative studies published from January 1, 2005, to February 15, 2019. REVIEW METHODS: Two investigators screened each abstract and full-text article for inclusion, abstracted data, rated quality and applicability, and graded evidence. When possible, random-effects models were used to compute summary estimates of effects. RESULTS: Our review included 167 articles (158 unique studies). Studies included 25 relevant to defining abnormal labor, 12 relevant to amniotomy, 75 relevant to supportive care measures, 25 relevant to epidural analgesia, 1 relevant to cervical examination, 1 relevant to intrauterine pressure catheters, 17 relevant to high-dose versus low-dose oxytocin protocols, 1 relevant to fetal monitoring strategies, and 7 relevant to timing of pushing in the second stage. Evidence suggests that the duration and pattern of "normal" labor progress based on modern management are quite different from historical data, and that labor progress differs between nulliparous and parous women. Use of partograms did not change important maternal or neonatal outcomes, although the applicability of this evidence to modern U.S. settings is limited. Routine amniotomy decreased the total duration of labor in nulliparous women without affecting other outcomes (moderate strength of evidence [SOE]); routine amniotomy with oxytocin augmentation decreased labor duration without increasing cesarean delivery (high SOE). Although supportive care is considered to improve parental satisfaction with the birthing process, satisfaction outcomes were rarely assessed in the included clinical trials. An existing systematic review of 11 studies found that women receiving continuous emotional support were less likely to rate their birth experience negatively. Of the different types of supportive therapies, only emotional support interventions showed reductions in cesarean (low SOE for doula support, moderate SOE for continuous emotional support) and instrumental deliveries (moderate SOE). For women choosing analgesia (epidural vs. combined spinal epidural, or epidural vs. patient-controlled intravenous analgesia), neither type nor timing affected cesarean delivery rates (moderate SOE). CONCLUSIONS: The normal progress of labor given current practice is quite different from that originally described, although there is still uncertainty about the duration of "normal" labor in the absence of augmentation. Further work is needed to identify (1) the cesarean delivery rate that optimally balances maternal and neonatal outcomes and patient preferences, and (2) the best strategies to achieve this rate.

*32479038*
 32479038

Standardized Library of Depression Outcome Measures

Standardized Library of Depression Outcome Measures-/-AHRQ Methods for Effective Health Care 2020; ():

This document describes the technical approach used to prepare the Standardized Library of Depression Outcome Measures workbook. For reference, the narrative definitions for the minimum set of outcome measures produced by the Depression Workgroup are included in Appendix A.

*32463629*
 32463629

Amiloride, fluoxetine or riluzole to reduce brain volume loss in secondary progressive multiple sclerosis: the MS-SMART four-arm RCT

Amiloride, fluoxetine or riluzole to reduce brain volume loss in secondary progressive multiple sclerosis: the MS-SMART four-arm RCT-/-Efficacy and Mechanism Evaluation 2020; ():

BACKGROUND: Neuroprotective drugs are needed to slow or prevent neurodegeneration and disability accrual in secondary progressive multiple sclerosis. Amiloride, fluoxetine and riluzole are repurposed drugs with potential neuroprotective effects. OBJECTIVES: To assess whether or not amiloride, fluoxetine and riluzole can reduce the rate of brain volume loss in people with secondary progressive multiple sclerosis over 96 weeks. The secondary objectives that were assessed were feasibility of a multiarm trial design approach, evaluation of anti-inflammatory effects, clinician- and patient-reported efficacy and three mechanistic substudies. DESIGN: A multicentre, multiarm, randomised, double-blind, placebo-controlled, parallel-group Phase IIb trial with follow-up at 4, 8, 12, 24, 36, 48, 72 and 96 weeks. Patients, investigators (including magnetic resonance imaging analysts), and treating and independent assessing neurologists were blinded to the treatment allocation. The target sample size was 440 patients. SETTING: Thirteen UK clinical neuroscience centres. PARTICIPANTS: Participants were aged 25-65 years, had secondary progressive multiple sclerosis with evidence of disease progression independent of relapses in the previous 2 years, and had an Expanded Disability Status Scale score of 4.0-6.5. Patients were ineligible if they could not have a magnetic resonance imaging scan; had a relapse or steroids in the previous 3 months; or had epilepsy, depression, bipolar disorder, glaucoma, bleeding disorders or significant organ comorbidities. Exclusion criteria were concurrent disease-modified treatments, immunosuppressants or selective serotonin reuptake inhibitors. INTERVENTIONS: Participants received amiloride (5 mg), fluoxetine (20 mg), riluzole (50 mg) or placebo (randomised 1 : 1 : 1 : 1) twice daily. MAIN OUTCOME MEASURES: The primary end point was magnetic resonance imaging-derived percentage brain volume change at 96 weeks. Secondary end points were new/enlarging T2 lesions, pseudoatrophy, and clinician- and patient-reported measures (including the Expanded Disability Status Scale, Multiple Sclerosis Functional Composite, Symbol Digit Modalities Test, low-contrast letter visual acuity, Multiple Sclerosis Impact Scale 29 items, version 2, Multiple Sclerosis Walking Scale, version 2, and questionnaires addressing pain and fatigue). The exploratory end points included measures of persistent new T1 hypointensities and grey matter volume changes. The substudies were advanced magnetic resonance imaging, optical coherence tomography and cerebrospinal fluid analyses. RESULTS: Between December 2014 and June 2016, 445 patients were randomised (analysed) to amiloride [n = 111 (99)], fluoxetine [n = 111 (96)], riluzole [n = 111 (99)] or placebo [n = 112 (99)]. A total of 206 randomised patients consented to the advanced magnetic resonance imaging substudy, 260 consented to the optical coherence tomography substudy and 70 consented to the cerebrospinal fluid substudy. No significant difference was seen between the active drugs and placebo in percentage brain volume change at week 96 as follows (where negative values mean more atrophy than placebo): amiloride minus placebo 0.0% (Dunnett-adjusted 95% confidence interval -0.4% to 0.5%), fluoxetine minus placebo -0.1% (Dunnett-adjusted 95% confidence interval -0.5% to 0.3%); riluzole minus placebo -0.1% (Dunnett-adjusted 95% confidence interval -0.6% to 0.3%). There was good adherence to study drugs. The proportion of patients experiencing adverse events was similar in the treatment and placebo groups. There were no emergent safety issues. LIMITATIONS: There was a lower than expected uptake in the cerebrospinal fluid substudy. CONCLUSIONS: A multiarm Phase II paradigm is efficient in determining which neuroprotective agents to take through to Phase III trials. Amiloride, fluoxetine and riluzole were not effective in reducing the brain atrophy rate in people with secondary progressive multiple sclerosis. Mechanistic pathobiological insight was gained. FUTURE WORK: To use the information gained from the Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (MS-SMART) to inform future trial design as new candidate agents are identified. TRIAL REGISTRATION: Current Controlled Trials ISRCTN28440672, NCT01910259 and EudraCT 2012-005394-31. FUNDING: This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 7, No. 3. See the NIHR Journals Library website for further project information. This trial also received funding from the UK MS Society and the US National Multiple Sclerosis Society.

*32453521*
 32453521

Prevention and treatment of venous thromboembolism in hospital and the community: a research programme including the ExACT RCT

Prevention and treatment of venous thromboembolism in hospital and the community: a research programme including the ExACT RCT-/-Programme Grants for Applied Research 2020; ():

BACKGROUND: Deep-vein thrombosis and pulmonary embolism, collectively known as venous thromboembolism when clots are formed in the venous circulation, are common disorders that are often unprovoked (i.e. there is no obvious reason for the clot occurring). Some people, after having an unprovoked clot, are at a high risk of developing another, or at risk of developing a secondary clot, most importantly in the lungs. Furthermore, in the long term, some patients will develop circulation problems known as post-thrombotic syndrome. The aim of this programme was to improve the understanding of both the prevention and the treatment of thrombosis in people at the highest risk of recurrence. OBJECTIVES: To clarify if it is possible to identify those people at the highest risk of having a recurrent venous thromboembolism, and if it is possible to prevent this happening by giving anticoagulation treatment for longer. To clarify if it is possible to identify those people at the highest risk of developing post-thrombotic syndrome. To document the current knowledge level about prevention and treatment of venous thromboembolism. To find what the barriers are to implementing measures to prevent venous thromboembolism. To find the most cost-effective means of treating venous thromboembolism. DESIGN: Mixed methods, comprising a randomised controlled trial, qualitative studies, cost-effectiveness analyses and questionnaire studies, including patient preferences. SETTING: UK general practices and hospitals, predominantly from the Midlands and Shropshire. PARTICIPANTS: Adults attending participating anticoagulation clinics with a diagnosis of first unprovoked deep-vein thrombosis or pulmonary embolism, and health-care professionals, patients and other stakeholders who were involved in the prevention and treatment of venous thromboembolism. INTERVENTION: Extended treatment with oral anticoagulation therapy (2 years) versus standard care (treatment with oral anticoagulation therapy for at least 3 months). RESULTS: Work package 1 demonstrated that extended anticoagulation for up to 2 years was clinically effective and cost-effective in reducing the incidence of recurrent venous thromboembolism, with a small increase in the risk of bleeding. There was no difference in post-thrombotic syndrome incidence or severity, or quality of life, between those undergoing the extended treatment and those receiving the standard care. Work package 2 identified five common themes with regard to the prevention of hospital-acquired thrombosis: communication, knowledge, role of primary care, education and training, and barriers to patient adherence. Work package 3 suggested that extended anticoagulation with novel oral anticoagulants was cost-effective only at the pound20,000-per-quality-adjusted life-year level for a recurrence rate of between 17.5% and 22.5%, depending on drug acquisition costs, while identifying a strong patient preference for extended anticoagulation based on a fear of recurrent venous thromboembolism. LIMITATIONS: The major limitation was the failure to reach the planned recruitment target for work package 1. CONCLUSIONS: Extended anticoagulation with warfarin for a first unprovoked venous thromboembolism is clinically effective and cost-effective and is strongly preferred by patients to the alternative of not having treatment. There are significant barriers to the implementation of preventative measures for hospital-acquired thrombosis. Further research is required on identifying patients in whom it is safe to discontinue anticoagulation, and at what time point following a first unprovoked venous thromboembolism this should be done. TRIAL REGISTRATION: Current Controlled Trials ISRCTN73819751 and EudraCT 2101-022119-20. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 8, No. 5. See the NIHR Journals Library website for further project information.

*32453520*
 32453520

Sit-stand desks to reduce sedentary behaviour in 9- to 10-year-olds: the Stand Out in Class pilot cluster RCT

Sit-stand desks to reduce sedentary behaviour in 9- to 10-year-olds: the Stand Out in Class pilot cluster RCT-/-Public Health Research 2020; ():

BACKGROUND: Sedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. The school classroom represents an ideal setting for environmental change through the provision of sit-stand desks. OBJECTIVES: The aim of this study was to undertake a pilot cluster randomised controlled trial of the introduction of sit-stand desks in primary school classrooms, to inform a definitive trial. Objectives included providing information on school and participant recruitment and retention, acceptability of the intervention, and outcome measures. A preliminary estimate of the intervention's effectiveness on the proposed primary outcome (change in weekday sitting time) for inclusion in a definitive trial was calculated, along with a preliminary assessment of potential cost-effectiveness. A full process evaluation was also undertaken. DESIGN: A two-armed pilot cluster randomised controlled trial with economic and qualitative evaluations. Schools were randomised on a 1 : 1 basis to the intervention (n = 4) or control (n = 4) trial arms. SETTING: Primary schools in Bradford, West Yorkshire, UK. PARTICIPANTS: Children in Year 5 (i.e. aged 9-10 years). INTERVENTION: Six sit-stand desks replaced three standard desks (sitting six children) in the intervention classrooms for 4.5 months. Teachers were encouraged to ensure that all pupils were exposed to the sit-stand desks for at least 1 hour per day, on average, using a rotation system. Schools assigned to the control arm continued with their usual practice. MAIN OUTCOME MEASURES: Trial feasibility outcomes included school and participant recruitment and attrition, acceptability of the intervention, and acceptability of and compliance with the proposed outcome measures [including weekday sitting measured using activPAL (PAL Technologies Ltd, Glasgow, UK) accelerometers, physical activity, adiposity, blood pressure, cognitive function, musculoskeletal comfort, academic progress, engagement and behaviour]. RESULTS: Thirty-three per cent of schools approached and 75% (n = 176) of eligible children took part. At the 7-month follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63% to 97%. A preliminary estimate of intervention effectiveness, from a weighted linear regression model (adjusting for baseline sitting time and wear time) revealed a mean difference in change in sitting of -30.6 minutes per day (95% confidence interval -56.42 to -4.84 minutes per day) between the intervention and control trial arms. The process evaluation revealed that the intervention, recruitment and evaluation procedures were acceptable to teachers and children, with the exception of minor issues around activPAL attachment. A preliminary within-trial economic analysis revealed no difference between intervention and control trial arms in health and education resource use or outcomes. Long-term modelling estimated an unadjusted incremental cost-effectiveness ratio of Stand Out in Class of pound78,986 per quality-adjusted life-year gained. CONCLUSION: This study has provided evidence of the acceptability and feasibility of the Stand Out in Class intervention and evaluation methods. Preliminary evidence suggests that the intervention may have a positive direction of effect on weekday sitting time, which warrants testing in a full cluster randomised controlled trial. Lessons learnt from this trial will inform the planning of a definitive trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12915848. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 8. See the NIHR Journals Library website for further project information.

*32421274*
 32421274

Drug-Resistant Tuberculosis: A Review of the Guidelines

Drug-Resistant Tuberculosis: A Review of the Guidelines-/-CADTH Rapid Response Reports 2020; ():

Tuberculosis (TB) is an infectious disease caused by the bacteria Mycobacterium tuberculosis and is transmitted through the air by those who are infected with the bacteria (i.e., coughing). According to the World Health Organization (WHO),(1) roughly a quarter of the world's population is infected with M. tuberculosis and may be at risk for developing the disease. TB typically affects the lungs of a person (i.e., pulmonary TB) but can also spread to other parts of the body (i.e., extrapulmonary TB). TB is prevalent in low and middle income countries, as the disease is associated with poverty, poor sanitation or hygiene practices and being easily transmissible from person to person.(1) However, high income countries, including Canada, still report cases of TB and it is considered an important public health matter. According to the Public Health Agency of Canada (PHAC),(2) Canada has one of the lowest rates of active TB disease in the world. However, annual rates of TB have remained the same in the country since the 1980's rather than steadily declining.(2) In 2017, PHAC reported 1,796 cases of active TB in Canada with migrants and Indigenous peoples bearing the highest rates of active TB in the country and approximately 70% of cases being pulmonary TB.(2)(,)(3) Individuals with TB are categorized into latent TB infection (LTBI) and active TB disease.(1)(,)(4) LTBI refers to an individual who has the M. tuberculosis infection in which the bacteria are alive but are not currently causing active TB disease.(4) Active TB disease occurs when the TB bacteria begins to multiply and the individual's immune system is compromised, leading to disease.(4) Moreover, patients with active TB disease can have drug-resistant TB (DR-TB). DR-TB refers to cases of TB where the bacteria are resistant to one of the first-line therapies for TB (e.g., isoniazid).(5) More specifically patients can be categorized as having multi-drug resistance (MDR-TB) when the bacteria are resistant to at least isoniazid and rifampicin, the two most commonly used drugs for TB treatment.(5) They can also be categorized as extensively drug-resistant TB (XDR-TB) when the bacteria are resistant to isoniazid and rifampin, plus any fluoroquinolone and at least one of three injectable second-line drugs.(6)(,)(7) Patients with MDR-TB and XDR-TB have fewer treatment options. According to the WHO, there are approximately 490,000 cases of MDR-TB worldwide.(6)(,)(7) MDR-TB and XDR-TB cases are on this rise and may be due to mismanagement of treatment or person-to-person transmission, leading to higher drug resistance. Proper diagnosis and treatment regimens for DR-TB, MDR-TB and XDR-TB can help control drug-resistant cases.(6)(,)(7) There are numerous guidelines published on TB that may vary in quality and the topics covered, which may make it difficult for health care professionals to select the optimal care for patients with DR-TB. The purpose of this report is to review and critically appraise the evidence-based guidelines regarding DR-TB. This report is part of series of evidence reviews on TB guidelines and can serve as a guidance document to identify which guidelines include recommendations for DR-TB. This report does not cover LTBI and drug-susceptible TB, which can be found in separate reports.(8)(-)(10) This report focuses on strategies for the prevention, identification, and treatment of DR-TB. This report is a component of a larger CADTH Condition Level Review on TB. A condition level review is an assessment that incorporates all aspects of a condition, from prevention, detection, treatment, and management. For more information on CADTH's Condition Level Review of TB, please visit the project page (https://www.cadth.ca/tuberculosis).

*33074613*
 33074613

Experiences with and Expectations of Robotic Surgical Systems: A Rapid Qualitative Review

Experiences with and Expectations of Robotic Surgical Systems: A Rapid Qualitative Review-/-CADTH Rapid Response Reports 2020; ():

Robotic surgery (RS) involves a surgeon at a console operating remote-controlled robotic arms that facilitate the performance of laparoscopic procedures.(1) The surgeon sits un-scrubbed at a console that provides them with a magnified pseudo 3-dimensional (3D) view of the surgical site. From the console, the surgeon is able to control the robot arms that hold the laparoscopic instruments inserted into the patient.(2) Over the past 20 years, RS has emerged as an alternative minimally invasive surgical strategy.(3) One system of surgical robots, da Vinci (Intuitive Surgical, California, USA), has been widely advertised and adopted by surgeons and hospitals since receiving approval from the United States Food and Drug Administration (FDA) in 2000.(4) There has been rapid growth in the purchase of da Vinci robots and in the number of RS procedures performed annually in North America and worldwide.(2) Other competing devices have been introduced to the market more recently (e.g., the Versius System or the Hugo System). While RS is most commonly used in urology and gynecology, its use is expanding across other surgical specialties, such as ear nose and throat, colorectal, cardiology, pediatrics, and plastic and reconstructive surgery.(2)(,)(5)(,)(6) Surgical advantages have been reported with RS including improved dexterity and intuitive instrument handling, reduction/elimination of tremors, motion scaling, and superior visualization including three-dimensional imaging.(2)(,)(7)(,)(8) Systematic reviews and meta-analyses have found the clinical benefits of RS to include less blood loss compared to conventional laparoscopic surgery,(9)(,)(10) shorter hospital stays as compared to open surgery and conventional laparoscopic surgery(9)(,)(11) and evidence indicates RS holds potential for smaller incisions with minimal scarring and faster recovery than nonrobotic-assisted procedures.(12) The CADTH Rapid Response report further outlines the clinical evidence on its Use in Gynecologic Oncology or Urologic Surgery. Overall, the evidence on RS as the superior surgical option is inconclusive and more trials are needed across surgical specialties. RS has introduced new challenges and additional responsibilities for surgical teams in an already challenging and multifaceted work environment.(13)(,)(14) Challenges with RS relate to the complex, highly technical equipment involved;(13)(,)(15) patient positioning; the long duration of the procedure;(16)(,)(17) and the separation of the primary surgeon from the patient.(13) These challenges may alter the way that members of the surgical team interact, affecting patient safety and quality of perioperative care related to RS.(13)(,)(15)(-)(17) An understanding of the factors that patients value with regards to robotic surgery and surgical teams' experiences with these robotic surgical systems is needed. This report summarizes the qualitative evidence of the patients' and surgical teams' experiences of robotic surgical systems.

*33074607*
 33074607

Treatment of Tuberculosis: A Review of Guidelines

Treatment of Tuberculosis: A Review of Guidelines-/-CADTH Rapid Response Reports 2020; ():

Tuberculosis (TB) is an infectious disease caused by the bacteria Mycobacterium tuberculosis and is transmitted through the air by those who are infected with the bacteria (i.e., coughing). According to the World Health Organization (WHO),(1) roughly a quarter of the world's population is infected with M. tuberculosis and may be at risk for developing the disease. TB typically affects the lungs of a person (i.e., pulmonary TB) but can also spread to other parts of the body (i.e., extrapulmonary TB). TB is prevalent in low and middle income countries, as the disease is associated with poverty, poor sanitation or hygiene practices and being easily transmissible from person to person.(1) However, high income countries, including Canada, still report cases of TB and it is considered an important public health matter. According to the Public Health Agency of Canada (PHAC),(2) Canada has one of the lowest rates of active TB disease in the world. However, annual rates of TB have remained the same in the country since the 1980's rather than steadily declining.(2) In 2017, PHAC reported 1,796 cases of active TB in Canada with migrants and Indigenous peoples bearing the highest rates of active TB in the country and approximately 70% of cases being pulmonary TB.(2)(,)(3) Individuals with TB are categorized into latent TB infection (LTBI) and active TB disease.(1)(,)(4) LTBI refers to an individual who has the M. tuberculosis infection in which the bacteria are alive but are not currently causing active TB disease.(4) Persons with LTBI do not possess any symptoms and are not contagious. However, those with the LTBI can develop active TB disease if they do not receive proper treatment.(4) Active TB disease (also known as active TB) occurs when the TB bacteria begins to multiply and the individual's immune system is compromised, leading to infection.(4) Active TB disease can develop shortly or long after infection, depending on the individual. Symptoms of active TB disease can include excessive coughing, chest pain, weight loss, fever, and fatigue.(4) Persons with active TB disease can spread the TB bacteria to others and are considered contagious.(4) The treatment of TB, both LTBI and active TB disease, is a priority for public health officials. The overall goal of TB treatment is to eradicate the M. Tuberculosis infection. Treating patients for LTBI is done to prevent LTBI from developing into active TB.(5) Treatment for active TB disease is focused on improving the patient's clinical condition, preventing the development or worsening of drug-resistance, and preventing relapse of the disease.(6) The treatments differ for LTBI and active TB disease, although there may be some overlap across therapies. It is important that an individual receives the correct diagnosis of either latent or active TB for the individual to receive optimal treatment.(7) There are several drug options for the treatment of LTBI and active TB disease, and treatment regimens may depend on the age of the individual (e.g., pediatric, adult, elderly patients etc.), co-morbidities (e.g., hepatitis, HIV, renal insufficiency), availability of drugs, the ability to adhere to treatment, and whether the TB is drug-susceptible.(5)(,)(6) There are numerous guidelines published on TB treatment, and these guidelines may vary in quality and the topics covered, which may make it difficult for health care professionals to select the optimal treatment for patients with TB.(8) The purpose of this report is to review and critically appraise the evidence-based guidelines regarding the treatment of TB. This report is part of series of evidence reviews on TB guidelines and can serve as a guidance document to identify which guidelines include recommendations for the treatment of latent and active TB and the strength of the guidelines. This report does not cover recommendations regarding the treatment of multi-drug resistant TB, or treating TB in people with HIV or conditions that compromise the immune system, as these topics are covered in separate reports.(9)(,)(10) This report focuses on treatment strategies for LTBI and active TB disease. This report is a component of a larger CADTH Condition Level Review on TB. A condition level review is an assessment that incorporates all aspects of a condition, from prevention, detection, treatment, and management. For more information on CADTH's Condition Level Review of TB, please visit the project page (https://www.cadth.ca/tuberculosis).

*33074600*
 33074600

2020 surveillance of blood transfusion (NICE guideline NG24)

2020 surveillance of blood transfusion (NICE guideline NG24)-/- 2020; ():

*32813480*
 32813480

Review of the Draft NTP Monograph: Systematic Review of Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects

Review of the Draft NTP Monograph: Systematic Review of Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

The National Toxicology Program (NTP) conducted a systematic review of the evidence of adverse neurodevelopmental and cognitive effects of fluoride exposure. NTP's conclusions are summarized in the monograph Systematic Review of Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects. At the request of NTP, a committee convened by the National Academies reviewed their monograph to ensure the integrity of that report. It is important to note that the committee was tasked with reviewing the monograph and focused its efforts on evaluating whether evidence as presented in the monograph supported NTP's conclusions. Thus, it did not conduct its own independent evaluation of the evidence, and it did not conduct a data audit. However, it did review some key literature to enable its review of the monograph. Review of the Draft NTP Monograph contains findings and suggestions for improvements and some overarching findings concerning methods, assessment of animal and human evidence, and NTP's hazard conclusion.

*32200598*
 32200598

Using Research and Technology to Address Compounding Disparities: Proceedings of a Workshop-in Brief

Using Research and Technology to Address Compounding Disparities: Proceedings of a Workshop-in Brief-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

A multi-sectoral, interdisciplinary approach to understanding the dimensions and determinants of social disparities and their intersections is necessary to work toward equity and equality of opportunity as rapid technology innovation changes the future of work. To examine the matter, the Government-University-Industry Research Roundtable held a workshop at the National Academy of Sciences on October 15-16, 2019 to consider how the research community of federal and state governments, academia, companies, and other actors can take institutional and collective action to identify and address disparities at the intersections that will make interventions most effective. The workshop explored how research institutions act as anchors in their communities to reach marginalized populations and considered best practices for community engagement. This publication summarizes the presentation and discussion of the workshop.

*32186838*
 32186838

2019 exceptional surveillance of chronic obstructive pulmonary disease in over 16s: diagnosis and management (NICE guideline NG115)

2019 exceptional surveillance of chronic obstructive pulmonary disease in over 16s: diagnosis and management (NICE guideline NG115)-/- 2020; ():

*32813479*
 32813479

Brain Health Across the Life Span: Proceedings of a Workshop

Brain Health Across the Life Span: Proceedings of a Workshop-/- 2020; ():

Brain health affects Americans across all ages, genders, races, and ethnicities. Enriching the body of scientific knowledge around brain health and cognitive ability has the potential to improve quality of life and longevity for many millions of Americans and their families. The Centers for Disease Control and Prevention estimate that as many as 5 million Americans were living with Alzheimer's disease in 2014. That same year, more than 800,000 children were treated for concussion or traumatic brain injuries in U.S. emergency departments. Each year, more than 795,000 people in the United States have a stroke. Developing more effective treatment strategies for brain injuries and illnesses is essential, but brain health is not focused exclusively on disease, disorders, and vulnerability. It is equally important to better understand the ways our brains grow, learn, adapt, and heal. Addressing all of these domains to optimize brain health will require consideration about how to define brain health and resilience and about how to identify key elements to measure those concepts. Understanding the interactions between the brain, the body, and socioenvironmental forces is also fundamental to improving brain health. To explore issues related to brain health throughout the life span, from birth through old age, a public workshop titled Brain Health Across the Life Span was convened on September 24 and 25, 2019, by the Board on Population Health and Public Health Practice in the Health and Medicine Division of the National Academies. This publication summarizes the presentation and discussion of the workshop.

*32352692*
 32352692

Review of the Department of Defense Biokinetic Modeling Approach in Support of Establishing an Airborne Lead Exposure Limit

Review of the Department of Defense Biokinetic Modeling Approach in Support of Establishing an Airborne Lead Exposure Limit-/- 2020; ():

Biokinetic modeling provides a mathematical technique for estimating absorption, distribution, metabolism, and excretion of chemicals, including particles and metals, in humans. Such models can be used to relate the amount of lead external exposure to the amount of lead found in the blood and other tissues at different points in time. At the request of the Department of Defense (DoD), Review of the Department of Defense Biokinetic Modeling Approach in Support of Establishing an Airborne Lead Exposure Limit evaluates whether the model used by DoD to derive airborne lead concentrations from blood lead levels is appropriate. This report also considers whether DoD's modifications to the model are appropriately justified, and whether the assumptions in and inputs to the model are reasonable.

*32352691*
 32352691

Relationship between volume of services and quality of treatment outcome in the surgical treatment of breast cancer - rapid report IQWiG Reports - Commission No. V18-05

Relationship between volume of services and quality of treatment outcome in the surgical treatment of breast cancer - rapid report IQWiG Reports - Commission No. V18-05-/-Institute for Quality and Efficiency in Health Care: Extracts 2020; ():

RESEARCH QUESTION: The aim of this investigation is to - present and assess any correlation between the volume of services (VoS) and the quality of the treatment outcome in the surgical treatment of primary mammary carcinoma (research question 1) and - present studies which investigate the effects of a minimum number of cases introduced into the healthcare system on the quality of the treatment outcome in the surgical treatment of primary mammary carcinoma (research question 2). If this process reveals data on a correlation between VoS and quality of treatment outcome in palliative surgery, they will be presented as supplementary information. CONCLUSION: For the investigation of any correlation between VoS and treatment quality in the surgical treatment of breast cancer, a total of 10 studies were included. One of the 10 included studies was assessed as having a high informative value of results. For the outcome of all-cause mortality, based on a high informative value of results, a correlation between both hospital and doctor VoS and treatment quality was derived. Hence, a higher VoS is associated with lower mortality rates. For other mortality outcomes (breast cancer mortality and other-cause mortality), based on a low informative value of results, a correlation was found either only on the hospital level or only on the doctor level. Again, the results showed lower mortality for these levels. With respect to performing a reoperation, based on a low informative value of results, it was possible to derive a correlation between both doctor and hospital VoS and treatment quality. At the hospital level, a correlation between VoS and treatment quality was apparent even in comparison with the intermediate VoS category. The results show lower reoperation rates in higher VoS categories. No studies of meaningful interpretive value were found which investigated any correlation between VoS and treatment quality reflected by other outcomes, such as adverse effects of therapy, local recurrence, disease-free survival, or health-related quality of life. Further, it was not possible to include studies of meaningful interpretive value investigating any effects of specifically introduced minimum case numbers.

*32200601*
 32200601

CADTH Canadian Drug Expert Committee Recommendation: Iron Isomaltoside 1000 (Monoferric - Pharmacosmos A/S): Indication: For the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy. The diagnosis must be based on laboratory tests

CADTH Canadian Drug Expert Committee Recommendation: Iron Isomaltoside 1000 (Monoferric - Pharmacosmos A/S): Indication: For the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy. The diagnosis must be based on laboratory tests-/-CADTH Common Drug Reviews 2020; ():

*33231954*
 33231954

CADTH Canadian Drug Expert Committee Recommendation: Sodium Zirconium Cyclosilicate (Lokelma - Astrazeneca Canada Inc.): Indication: Hyperkalemia.

CADTH Canadian Drug Expert Committee Recommendation: Sodium Zirconium Cyclosilicate (Lokelma - Astrazeneca Canada Inc.): Indication: Hyperkalemia.-/-CADTH Common Drug Reviews 2020; ():

*33151651*
 33151651

Body Weight Modification Interventions for Chronic Non-Cancer Pain: A Review of Clinical Effectiveness

Body Weight Modification Interventions for Chronic Non-Cancer Pain: A Review of Clinical Effectiveness-/-CADTH Rapid Response Reports 2020; ():

In 2016, the World Health Organization estimated 1.9 billion adults (age >/= 18 years) to be overweight (body mass index, BMI = 25-29.9 kg/m(2)) and 650 million to be obese (BMI >/= 30 kg/m(2)).(1) Amongst other symptoms, individuals who are overweight are more likely to suffer from fatigue, depression, and chronic pain.(2)(,)(3) Chronic pain affects about one in five Canadian adults (age >/= 18 years) and one in three seniors (age >/= 65 years).(4) This has considerable economic implications as an estimated annual direct cost of $7.2 billion is associated with managing chronic pain in Canada.(5) Chronic non-cancer pain is commonly caused by neuropathy, lower back issues, or arthritis.(6) Studies have shown obesity to be associated with knee and hip pain.(7) This link between chronic pain and obesity is related, in part, to the mechanical load on weight-bearing joints.(7) This is especially relevant in patients with knee osteoarthritis (KOA) as the knee joint is most commonly affected in the lower extremities.(8) As a chronic degenerative disease that could result in permanent damage to bone joints, osteoarthritis is the most common type of arthritis.(9) With the goal of helping patients lose and maintain long-term weight loss, non-surgical treatments for obesity have been associated with benefits for obesity-related comorbidities.(10) Non-pharmacological options for pain and mobility include, but are not limited to, strength training, aerobic exercise, yoga, massage therapy, orthotics, and/or weight loss interventions.(11) Weight loss interventions can involve multidisciplinary teams consisting of dieticians, physiologists, and clinical psychologists.(8) Differences exist in weight management programs, which can incorporate diet (e.g., caloric restriction), exercise (e.g., aerobic and/or strength training), behavioural education (e.g., self-regulatory skills), or various combinations of these interventions.(8) In February 2020, a CADTH Rapid Response Reference List report indicated the availability of relevant literature regarding the clinical effectiveness of body weight modification interventions for chronic non-cancer pain, as well as evidence-based guidelines regarding body weight modification for chronic, non-cancer pain.(12) The objective of this report is to review and summarize the relevant literature regarding the clinical effectiveness of body weight modification interventions for chronic non-cancer pain.

*33074625*
 33074625

Venous thromboembolic diseases: diagnosis, management and thrombophilia testing

Venous thromboembolic diseases: diagnosis, management and thrombophilia testing-/-National Institute for Health and Care Excellence: Clinical Guidelines 2020; ():

This guideline covers diagnosing and managing venous thromboembolic diseases in adults. It aims to support rapid diagnosis and effective treatment for people who develop deep vein thrombosis (DVT) or pulmonary embolism (PE). It also covers testing for conditions that can make a DVT or PE more likely, such as thrombophilia (a blood clotting disorder) and cancer. The guideline does not cover pregnant women.WHO IS IT FOR? Commissioners and providers of venous thromboembolism services. Healthcare professionals in primary, secondary and tertiary care. Adults (18 and over) with suspected or confirmed DVT or PE, their families and carers. First-degree relatives of people with inherited thrombophilia or other venous thromboembolic diseases.

*32374563*
 32374563

Intravitreal Dexamethasone Implants for Non-infectious Uveitis: A Review of Clinical Effectiveness, Cost-effectiveness, and Guidelines

Intravitreal Dexamethasone Implants for Non-infectious Uveitis: A Review of Clinical Effectiveness, Cost-effectiveness, and Guidelines-/-CADTH Rapid Response Reports 2020; ():

Uveitis is a disease characterized by inflammation of the uvea.(1) Uvea is the middle layer of the eye wall. The anterior uvea segment includes the iris and ciliary body, intermediate uvea includes vitreous humor, and posterior uvea segment is known as the choroid.(2) Based on the location of the Inflammation, uveitis can be classified as anterior uveitis (AU), intermediate uveitis (IU), posterior uveitis (PU) and panuveitis.(2) Panuveitis is defined as uveitis involving all parts of uvea.(1) Based on the etiology, uveitis can be divided into infectious uveitis and non-infectious uveitis (NIU).(2) NIU includes uveitis caused by systemic immune-mediated disease, immune-related drug reactions, or some syndromes resulting in uveitis.(2) The common complications of uveitis include cystoid macular edema (CME), cataract, intraocular pressure elevation, and glaucoma; the risk of specific complications of uveitis depends on the underlying illness.(2)(,)(3) Treatment of NIU is still clinically challenging.(4) There is very limited information from controlled trials.(3) The treatment choice for NIU depends upon the location of the uveitis (such as AU/IU/PU). In the literature, it has been indicated that the initial treatment for non-infectious posterior uveitis is corticosteroids administered locally or systemically.(1) Non-infectious anterior uveitis is commonly treated with topical glucocorticoids. However, posterior uveitis is generally not responsive to topical medication.(3) Intravitreal dexamethasone implant (IDI, 0.7 mg, Ozurdex) is usually used for patients with uveitis, when underlying systemic disease is well controlled or is not present.(1) Following corticosteroids, immunosuppressive drugs including methotrexate and azathioprine are commonly used. Long-term use of systemic corticosteroids above 7.5 mg per day is not recommended due to potential adverse effects such as cataract, glaucoma, etc.(1) In Canada, intravitreal dexamethasone implants (IDI) are indicated for the treatment of NIU affecting the posterior segment of the eye.(5) The pivotal trial used to support the Health Canada's indication was a single, multicenter, masked RCT for the treatment of NIU affecting the intermediate and posterior segment of the eye.(5)(,)(6) In the treatment of NIU, the Health Canada recommended dose regimen of IDI is one dose. The product monograph notes that for uveitis, there is no experience with reinjection and it is therefore not recommended (p. 4) but also notes that the need for IDI reinjection is determined by physician based on patient's clinical need.(5) For other indications (e.g. diabetic macular edema), reinjection at an interval of six months between two injections has been recommended.(5) IDI is not recommended by Health Canada for pediatric use.(5) The purpose of this report is to review the clinical effectiveness, safety, cost-effectiveness of IDI in the treatment of NIU. Of particular interest is evidence on different dose regimens of IDI (e.g., a single implant or two implants with approximately six months between doses, or continual treatment (i.e., three or more implants) or implants at intervals of less than every six months). In addition, this report also reviews the evidence-based guidelines on the treatment of NIU.

*33074617*
 33074617

Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting: Proceedings of a Workshop

Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Sharing knowledge is what drives scientific progress - each new advance or innovation in biomedical research builds on previous observations. However, for experimental findings to be broadly accepted as credible by the scientific community, they must be verified by other researchers. An essential step is for researchers to report their findings in a manner that is understandable to others in the scientific community and provide sufficient information for others to validate the original results and build on them. In recent years, concern has been growing over a number of studies that have failed to replicate previous results and evidence from larger meta-analyses, which have pointed to the lack of reproducibility in biomedical research. On September 25 and 26, 2019, the National Academies of Science, Engineering, and Medicine hosted a public workshop in Washington, DC, to discuss the current state of transparency in the reporting of preclinical biomedical research and to explore opportunities for harmonizing reporting guidelines across journals and funding agencies. Convened jointly by the Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Genomics and Precision Health, the workshop primarily focused on transparent reporting in preclinical research, but also considered lessons learned and best practices from clinical research reporting. This publication summarizes the presentation and discussion of the workshop.

*32207888*
 32207888

Masks for Prevention of Influenza Transmission in Acute and Long-Term Care Settings: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines

Masks for Prevention of Influenza Transmission in Acute and Long-Term Care Settings: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines-/-CADTH Rapid Response Reports 2020; ():

Influenza is a viral respiratory infection causing fever, cough, and general aches and pain.(1) Annual vaccination for select high-risk populations, including health care workers (HCW) and other people in contact with those at high risk of influenza, is recommended.(1)(-)(3) Transmission of influenza between infected HCWs and their vulnerable patients can result in morbidity and mortality.(2) Some HCWs are not vaccinated against influenza. In a 2011 Canadian systematic review (SR) of studies from Australia, Canada, Finland, Germany, Thailand, United Kingdom, and the United States of America, the influenza incidence rate amongst unvaccinated HCWs (in any type of care setting) was reported to be 18.69 (95% confidence interval = 15.80 to 22.11) per 100 population, per season.(4) In such instances, personal protective equipment (PPE) such as surgical masks and procedural masks are used to minimize exposures. However, there is uncertainty as to the evidence regarding the clinical effectiveness of masks at preventing the transmission of influenza between unvaccinated HCWs and patients. Previous CADTH reports on this topic include a 2017 Summary with Critical Appraisal on the use of respirators for protection against droplet borne illness,(5) a 2014 Summary with Critical Appraisal on the use of respiratory precautions for protection from infectious agents,(6) and a 2011 Technology Report on physical interventions to interrupt or reduce the spread of respiratory viruses.(7) The objective of the present report is to investigate the clinical effectiveness, cost-effectiveness, and evidence-based guidelines regarding the use of masks for unvaccinated HCWs to prevent the transmission of influenza in acute or long-term care settings.

*33074612*
 33074612

Oral Rehydration Solutions versus Drink of Choice in Children with Dehydration: A Review of Clinical Effectiveness

Oral Rehydration Solutions versus Drink of Choice in Children with Dehydration: A Review of Clinical Effectiveness-/-CADTH Rapid Response Reports 2020; ():

Children generally have a higher body water content (60-75%) compared to adults (55-60%).(1) Dehydration in children is a concern as their higher body water content makes them more prone to water, sodium and potassium loss during acute illnesses.(1) Vomiting, diarrhea, or other causes of excessive fluid loss can lead to varying degrees of dehydration from mild (3-5% weight loss) to moderate (6-10% weight loss) and severe (10-15% weight loss).(1) Symptoms of dehydration in children differ according to the degree of dehydration, but can include hyperirritability, lethargy, intense thirst, mottled or cyanotic skin, a rapid pulse, hypotension and shock in more severe cases.(1) Three types of dehydration can occur: isonatremic, hypernatremic, and hyponatremic.(1) Isonatremic dehydration is the most common presentation (80% of cases) and is characterized by equal loss of water and salt.(1) Hypernatremic dehydration represents a smaller fraction of cases (15%) and is characterized by a greater water loss.(1) Hyponatremic dehydration is the rarest presentation (5% of cases) and is characterized by either excessive water intake, sodium depletion or an artificial lowering of serum sodium concentration secondary to an increase in glucose, electrolytes, lipids and proteins.(1) The treatments of the different types of dehydration vary, but all involve replacing fluid deficits.(1) Oral rehydration therapy is the first line treatment for children with mild to moderate dehydration.(1) Commercially available oral rehydration solutions contain specific concentrations of sodium, potassium and glucose with the aim of optimizing fluid absorption through the gastrointestinal tract via the sodium-glucose cotransporter pump.(1)(,)(2) Oral rehydration solutions can thus be used for all types of dehydration as long as the serum sodium concentrations are not at the extreme ends of the spectrum in hyponatremic or hypernatremic dehydration.(1) However, oral rehydration solutions are considered to be prohibitively expensive for some patients (or their guardians) and often have an unpleasant taste.(3) This may lead to dehydrated children being treated with other beverages which may not contain the optimal carbohydrate and electrolyte concentrations needed for rehydration.(3) Other, often more palatable, oral rehydration options include water, clear broths, ice pops, and juice or sports drinks.(4) This report aims to summarize the evidence regarding the comparative clinical effectiveness of oral rehydration solution versus other fluids of choice for pediatric patients with, or at risk of, dehydration.

*33074626*
 33074626

Exploring the Current Landscape of Consumer Genomics: Proceedings of a Workshop

Exploring the Current Landscape of Consumer Genomics: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Consumer genomics, encompassing both direct-to-consumer applications (i.e., genetic testing that is accessed by a consumer directly from a commercial company apart from a health care provider) and consumer-driven genetic testing (i.e., genetic testing ordered by a health care provider in response to an informed patient request), has evolved considerably over the past decade, moving from more personal utility-focused applications outside of traditional health care to interfacing with clinical care in nontraditional ways. As consumer genomics has increasingly intersected with clinical applications, discussions have arisen around the need to demonstrate clinical and analytical validity and clinical utility due to the potential for misinterpretation by consumers. Clinical readiness and interest for this information have presented educational and training challenges for providers. At the same time, consumer genomics has emerged as a potentially innovative mechanism for thinking about health literacy and engaging participants in their health and health care. To explore the current landscape of consumer genomics and the implications for how genetic test information is used or may be used in research and clinical care, the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine hosted a public workshop on October 29, 2019, in Washington, DC. Discussions included such topics as the diversity of participant populations, the impact of consumer genomics on health literacy and engagement, knowledge gaps related to the use of consumer genomics in clinical care, and regulatory and health policy issues such as data privacy and security. A broad array of stakeholders took part in the workshop, including genomics and consumer genomics experts, epidemiologists, health disparities researchers, clinicians, users of consumer genomics research applications, representatives from patient advocacy groups, payers, bioethicists, regulators, and policy makers. This publication summarizes the presentations and discussion of the workshop.

*32721146*
 32721146

Abdominal aortic aneurysm: diagnosis and management

Abdominal aortic aneurysm: diagnosis and management-/-National Institute for Health and Care Excellence: Clinical Guidelines 2020; ():

This guideline covers diagnosing and managing abdominal aortic aneurysms. It aims to improve care by helping people who are at risk to get tested, specifying how often to monitor asymptomatic aneurysms, and identifying when aneurysm repair is needed and which procedure will work best.WHO IS IT FOR? Healthcare professionals. Commissioners and providers. People with an abdominal aortic aneurysm, and their families and carers.

*32407016*
 32407016

Propranolol for Post-Traumatic Stress Disorder: A Review of Clinical Effectiveness

Propranolol for Post-Traumatic Stress Disorder: A Review of Clinical Effectiveness-/-CADTH Rapid Response Reports 2020; ():

Post-traumatic stress disorder (PTSD) is a chronic mental health condition that may develop in individuals following direct or indirect exposure to a traumatic event.(1) Research indicates that the lifetime prevalence of trauma, which can be caused by numerous distressing events (e.g., exposure to actual or threatened death, serious injury, or sexual violence), is as high as 70% in the general population.(2)(,)(3) Although not every individual who experiences trauma will develop subsequent mental health issues such as PTSD, acute stress disorder, or depression, these conditions are associated with decreased quality of life and disability(4)(,)(5) and are among the leading contributors to the global burden of disease.(6) It is estimated that nearly 1 in 10 Canadians will experience PTSD at some point in their lifetime.(7) Research dating back to the 1980s has postulated that epinephrine and norepinephrine may play a role in the formation of traumatic memories, and thus in the development of PTSD.(8) Although the mechanism is not fully understood, literature suggests that epinephrine and norepinephrine released by the beta-adrenergic system as a result of trauma may enhance the formation of memories associated with emotional experiences and strengthen fear conditioning.(9)(,)(10) These findings have prompted subsequent research investigating the use of propranolol, a beta-blocker that inhibits the effects of these catecholamines by acting as a competitive antagonist on beta-adrenergic receptors,(11) for the treatment and prevention of PTSD. Research in this field has primarily focused on two main indications: 1) propranolol given to individuals prior to trauma memory reactivation in patients diagnosed with PTSD, and 2) propranolol given following trauma as a preventative measure for subsequent PTSD or acute stress disorder.(12) The purpose of this report is to summarize the clinical evidence regarding the effectiveness of propranolol for the treatment and prevention of PTSD.

*33074615*
 33074615

Key Policy Challenges and Opportunities to Improve Care for People with Mental Health and Substance Use Disorders: Proceedings of a Workshop

Key Policy Challenges and Opportunities to Improve Care for People with Mental Health and Substance Use Disorders: Proceedings of a Workshop-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Behavioral health and substance use disorders affect approximately 20 percent of the U.S. population. Of those with a substance use disorder, approximately 60 percent also have a mental health disorder. Together, these disorders account for a substantial burden of disability, have been associated with an increased risk of morbidity and mortality from other chronic illnesses, and can be risk factors for incarceration, homelessness, and death by suicide. In addition, they can compromise a person's ability to seek out and afford health care and adhere to treatment recommendations. To explore data, policies, practices, and systems that affect the diagnosis and provision of care for mental health and substance use disorders, the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine created the Forum on Mental Health and Substance Use Disorders. The forum activities are expected to advance the discussion and generate potential ideas on ways to address many of the most persistent problems in delivering mental health and substance use services. The inaugural workshop, held October 15-16, 2019, in Washington, DC, explored the key policy challenges that impede efforts to improve care for those individuals with mental health and substance use disorders. This publication summarizes the presentations and discussion of the workshop.

*32200599*
 32200599

Serial X-Ray Radiography for the Diagnosis of Osteomyelitis: A Review of Diagnostic Accuracy, Clinical Utility, Cost-Effectiveness, and Guidelines

Serial X-Ray Radiography for the Diagnosis of Osteomyelitis: A Review of Diagnostic Accuracy, Clinical Utility, Cost-Effectiveness, and Guidelines-/-CADTH Rapid Response Reports 2020; ():

Osteomyelitis is an inflammation of the bone due to infection caused by bacteria, commonly Staphylococcus aureus.(1) Bacteria can reach the bone through various means including trauma, surgery, the blood stream, extension from an adjacent soft tissue infection, or diabetic foot infection.(1) Osteomyelitis can occur at any age, although the incidence appears to peak at children under the age of five and in adults over 50 years of age.(2) It can be classified as acute or chronic, based on histopathological findings.(3) Factors associated with osteomyelitis include aging, increased prevalence of trauma, and increased prevalence of diabetic foot infection.(4) Early detection of osteomyelitis will likely lead to more favorable outcomes.(4) Diagnosis of osteomyelitis requires a multidisciplinary approach including clinical examination, recognition and assessment of clinical symptoms, laboratory investigations and imaging tests.(4) There are various imaging modalities that have been used in the characterization and differential diagnosis of osteomyelitis, such as plain X-ray radiography, computed tomography (CT), magnetic resonance imaging (MRI), bone scintigraphy, positron emission tomography (PET), single-photon emission computed tomography (SPECT), and ultrasonography.(1)(,)(4) The diagnostic accuracies of these imaging tests for diagnosis of osteomyelitis have been systematically reviewed.(5) Although plain X-ray radiography has lower sensitivity and specificity compared to other imaging tests, the American College of Radiology Appropriateness Criteria and reviews recommend that X-ray should be used as first line imaging modality to differentiate osteomyelitis from other clinical conditions such as bone fractures or bone malignancies.(3)(,)(6)(,)(7) Plain X-ray radiography, whether or not with positive or negative results, is usually followed by higher sensitivity and specificity imaging modalities for diagnosis of osteomyelitis.(8) However, in institutions where the availability of more sophisticated imaging modalities is limited, it is unclear if the use of serial X-ray radiography (i.e., initial assessment with X-rays followed by subsequent X-rays in 1 to 3 weeks), could improve diagnostic accuracy for detection of osteomyelitis. The aim of this report is to review the diagnostic accuracy, clinical utility, and cost-effectiveness of serial X-ray radiography in adults with suspected osteomyelitis compared to other diagnostic modalities. This report also aims to identify evidence-based guidelines regarding the use of diagnostic modalities in adults with suspected osteomyelitis.

*33074603*
 33074603

Temporomandibular Disorders: Priorities for Research and Care

Temporomandibular Disorders: Priorities for Research and Care-/-The National Academies Collection: Reports funded by National Institutes of Health 2020; ():

Temporomandibular disorders (TMDs), are a set of more than 30 health disorders associated with both the temporomandibular joints and the muscles and tissues of the jaw. TMDs have a range of causes and often co-occur with a number of overlapping medical conditions, including headaches, fibromyalgia, back pain and irritable bowel syndrome. TMDs can be transient or long-lasting and may be associated with problems that range from an occasional click of the jaw to severe chronic pain involving the entire orofacial region. Everyday activities, including eating and talking, are often difficult for people with TMDs, and many of them suffer with severe chronic pain due to this condition. Common social activities that most people take for granted, such as smiling, laughing, and kissing, can become unbearable. This dysfunction and pain, and its associated suffering, take a terrible toll on affected individuals, their families, and their friends. Individuals with TMDs often feel stigmatized and invalidated in their experiences by their family, friends, and, often, the health care community. Misjudgments and a failure to understand the nature and depths of TMDs can have severe consequences - more pain and more suffering - for individuals, their families and our society. Temporomandibular Disorders: Priorities for Research and Care calls on a number of stakeholders - across medicine, dentistry, and other fields - to improve the health and well-being of individuals with a TMD. This report addresses the current state of knowledge regarding TMD research, education and training, safety and efficacy of clinical treatments of TMDs, and burden and costs associated with TMDs. The recommendations of Temporomandibular Disorders focus on the actions that many organizations and agencies should take to improve TMD research and care and improve the overall health and well-being of individuals with a TMD.

*32200600*
 32200600

Tuberculosis in People with Compromised Immunity: A Review of Guidelines

Tuberculosis in People with Compromised Immunity: A Review of Guidelines-/-CADTH Rapid Response Reports 2020; ():

Tuberculosis (TB) is an infectious disease caused by the bacteria Mycobacterium tuberculosis and is transmitted through the air by those who are infected with the bacteria (i.e., coughing). There are two distinct categories of TB, latent TB infection (LTBI) and active TB disease (also known as active TB).(1)(,)(2) A person with LTBI is not contagious as they cannot spread the bacteria to others and do not possess any visible symptoms.(1) However, persons with LTBI can develop active TB if the infection is left untreated or the treatment regimen is not followed.(1) Active TB occurs when an individual's immune system is compromised and the bacteria begins to multiply leading to an active infection. Unlike LTBI, an individual with active TB is contagious and can spread the M. tuberculosis bacteria to others. Common symptoms associated with active TB include excessive coughing, chest pain, weight loss, fever, and fatigue.(1) Canada has one of the lowest rates of active TB disease in the world,(3) however, annual rates of TB in Canada have remained the same since the 1980's rather than declining.(3) Certain risk factors can increase the risk of TB, and these include increased exposure to the TB bacteria (e.g., close contact with someone with TB, or birth in an area with a high incidence of TB) as well as impaired immunity.(4) Impaired or compromised immunity can result from diseases that compromise the immune system (e.g., HIV infection, autoimmune disease, cancer), or from treatments that cause immunosuppression (e.g., anti-rejection drugs for transplant recipients, or tumor necrosis factor (TNF) inhibitors).(3)(,)(4) Patients with compromised immunity have a higher risk of LTBI infection, and developing active TB disease.(4) For instance, people with HIV have a higher risk of developing active TB disease compared to HIV-uninfected people due to their compromised immune system and the inability to adequately fight off infection.(5) Given the complexity of some of these conditions that compromise the immune system, there may be additional considerations for the prevention, identification, and treatment of TB in these patients. For instance, when identifying TB in patients with compromised immunity, the underlying condition (e.g., HIV infection) may alter the response to a TB diagnostic test. In addition, when treating TB, it may be necessary to consider whether the TB drugs will interact with the other therapies that patients are currently receiving (e.g., anti-TNF or antiretroviral therapies).(5) Moreover, patients on immunomodulators (e.g., anti-TNF) have an increased risk of reactivating TB infection due to the suppression of the individual's immune response, making it difficult to suppress TB infection.(6) Consequently, patients with compromised immunity may require alternative preventive, diagnostic, and treatment strategies for TB compared to the general population. There are numerous guidelines published regarding the prevention, identification, and treatment of TB. Some guidelines focus on TB in patients with compromised immunity, while other guidelines cover a broad spectrum of populations at risk of TB. These guidelines vary by the populations and topics covered, and the quality of the report, which may make it difficult for health care professionals to select the best guidance on TB in patients with compromised immunity.(7) The purpose of this report is to review and critically appraise the evidence-based guidelines regarding the prevention, identification, and treatment of TB for patients with compromised immunity. This report is part of series of evidence reviews on TB guidelines and can serve as a guidance document to identify which guidelines include recommendations for TB in patients with compromised immunity and the strength of the guidelines. This report covers recommendations regarding the prevention, identification, and treatment of TB in people with HIV or other conditions that compromise the immune system. This report is a component of a larger CADTH Condition Level Review on TB. A condition level review is an assessment that incorporates all aspects of a condition, from prevention, detection, treatment, and management. For more information on CADTH's Condition Level Review of TB, please visit the project page (https://www.cadth.ca/tuberculosis).

*33074604*
 33074604

Tinnitus: assessment and management

Tinnitus: assessment and management-/-National Institute for Health and Care Excellence: Clinical Guidelines 2020; ():

This guideline covers the assessment, investigation and management of tinnitus in primary, community and secondary care. It offers advice to healthcare professionals on supporting people presenting with tinnitus and on when to refer for specialist assessment and management. For adults with tinnitus and hearing loss, this guideline should be read together with the NICE guideline on hearing loss in adults.WHO IS IT FOR? Healthcare professionals. Social care practitioners. Commissioners of health and social care services. People with tinnitus, their family members and carers, and the public.

*32437098*
 32437098

CADTH Canadian Drug Expert Committee Recommendation: Ixekizumab (Taltz - Eli Lilly Canada Inc.): Indication: Ankylosing spondylitis

CADTH Canadian Drug Expert Committee Recommendation: Ixekizumab (Taltz - Eli Lilly Canada Inc.): Indication: Ankylosing spondylitis-/-CADTH Common Drug Reviews 2020; ():

*33237679*
 33237679

CADTH Canadian Drug Expert Committee Recommendation: Safinamide (Onstryv - Valeo Pharma Inc.): Indication: For add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD) in patients experiencing "OFF" episodes while on a stable dose of levodopa. Safinamide has not been shown to be effective as monotherapy for the treatment of PD

CADTH Canadian Drug Expert Committee Recommendation: Safinamide (Onstryv - Valeo Pharma Inc.): Indication: For add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD) in patients experiencing "OFF" episodes while on a stable dose of levodopa. Safinamide has not been shown to be effective as monotherapy for the treatment of PD-/-CADTH Common Drug Reviews 2020; ():

*33231955*
 33231955

Skin Preparation for Injections: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines

Skin Preparation for Injections: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines-/-CADTH Rapid Response Reports 2020; ():

Infection control is a priority for all health care professionals and includes a variety of practices commonly used for patients and the general public. One branch of infection control is skin preparation, also known as alcohol swabbing. This a common technique often involving the application of a disinfectant to the skin prior to a surgical or non-surgical procedures.(1) An example of skin preparation is when health professionals wipe (or swab) an alcohol or other disinfectant solution before they administer an injectable or when withdrawing blood from an individual. Although skin preparation has been widely used and implemented across health organizations, there has been recent debate whether skin preparation before vaccine (or other injectables) administration reduces infection rates for patients.(2) According to the World Health Organization (WHO)(1), injections are unsafe when administered with unsterile or improper technique and it is important to avoid contamination when administering injectables like vaccinations or medication (e.g., insulin). The WHO suggests that the standard practice for skin preparation with regards to vaccination or other injectables is swabbing the injection site with a saturated 60% to 70% alcohol swab for 30 seconds and allowing the area to dry for 30 seconds.(1) A variety of alcohol swabs are available on market including isopropyl or ethanol-based swabs. Alcohol swabs can be costly for health organizations to prioritize in budgets due to a high volume of vaccinations taking place. For instance, vaccination programs can be costly given the number of publicly funded vaccines recommended for Canadian children and adults as these programs not only encompass the administration of vaccines but also staff training, and infection control procedures surrounding vaccine administration, including skin preparation.(3) Various health organizations including the WHO,(1) United Kingdom's Department of Health,(4) and Australia's Department of Health(5) have stated that if the skin is visibly clean, disinfecting the skin (or alcohol swabbing) is not necessary and does not reduce infection. To the contrary, the Public Health Agency of Canada(6) advises the practice of cleaning the skin with a suitable antiseptic solution prior to vaccination or injection. Hence, there is ongoing debate whether the continued use of alcohol swabbing is clinically necessary and effective for routine injections or vaccinations. The purpose of this report is to summarize the evidence regarding the clinical effectiveness and cost-effectiveness of skin preparation prior to injections. Evidence-based guidelines regarding preparing the skin for injection will also be sought.

*33074639*
 33074639

Pharmacoeconomic Review Report: Glucagon Nasal Powder (Baqsimi): (Eli Lilly Canada Inc.): Indication: For the treatment of severe hypoglycemic reactions which may occur in the management of insulin treated patients with diabetes mellitus, when impaired consciousness precludes oral carbohydrates

Pharmacoeconomic Review Report: Glucagon Nasal Powder (Baqsimi): (Eli Lilly Canada Inc.): Indication: For the treatment of severe hypoglycemic reactions which may occur in the management of insulin treated patients with diabetes mellitus, when impaired consciousness precludes oral carbohydrates-/-CADTH Common Drug Reviews 2020; ():

Glucagon nasal powder (Baqsimi) is indicated for the treatment of severe hypoglycemia (SH) reactions that may occur in the management of insulin-treated patients with diabetes mellitus, when impaired consciousness precludes oral carbohydrates. It is supplied as a single use nasal dosing device containing a 3 mg single dose at a price of $131.60. The recommended dose is one spray in either nostril. According to the clinical expert consulted by CADTH, the treatment is prescribed to patients in preparation for an emergency involving the Health Canada (HC)-indicated SH event. The sponsor submitted a cost-utility analysis (CUA) based on a decision tree comparing the availability of intranasal glucagon with intramuscular (IM) glucagon for a bystander who noticed a patient experiencing the HC-indicated SH event. The sponsor modelled costs and health consequences arising from a single SH event managed with a single glucagon treatment over a one-year time horizon. The SH event was assumed to be witnessed by a bystander (either a caregiver or an acquaintance) who may decide to administer intranasal or IM glucagon in response. Whether glucagon treatment was attempted and was successful determined related events and health care resource use. A range of events of varying severity were captured, including potential resolution of an SH event without health care resource use; SH event resolution requiring emergency medical service (EMS), emergency department (ED) visit, or inpatient admission; and SH event follow-up care. A bystander with access to intranasal was assumed to be twice as likely to attempt administration of intranasal glucagon to the patient experiencing an SH event compared with attempting administration with IM glucagon. The probabilities of a successful full dose administration for intranasal and IM glucagon were based on the sponsor's treatment performance study of caregivers and other bystanders to a simulated SH event. The efficacy of successfully administered intranasal and IM glucagon was assumed to be equivalent, based on the sponsor's claim that noninferior efficacy was demonstrated in the sponsor's IGBC and IGBB studies. Other parameters were based on Canadian sources and were assumed to be the same between the intranasal glucagon and IM glucagon. Mortality and adverse events were not modelled. In the sponsor's base case, intranasal glucagon was associated with 0.001 incremental quality-adjusted life-years (QALYs) and cost savings of $382 compared with IM glucagon. At a willingness-to-pay threshold of $50,000 per QALY, intranasal glucagon had a 67% probability of being cost-effective compared with IM glucagon.

*33074627*
 33074627

Clinical Review Report: Glucagon Nasal Powder (Baqsimi): (Eli Lilly Canada Inc): Indication: For the treatment of severe hypoglycemic reactions which may occur in the management of insulin treated patients with diabetes mellitus, when impaired consciousness precludes oral carbohydrates

Clinical Review Report: Glucagon Nasal Powder (Baqsimi): (Eli Lilly Canada Inc): Indication: For the treatment of severe hypoglycemic reactions which may occur in the management of insulin treated patients with diabetes mellitus, when impaired consciousness precludes oral carbohydrates-/-CADTH Common Drug Reviews 2020; ():

The objective of this review was to perform a systematic review of the beneficial and harmful effects of glucagon nasal powder (Baqsimi) for the treatment of severe hypoglycemic reactions which may occur in the management of insulin-treated patients with diabetes mellitus, when impaired consciousness precludes oral carbohydrates.

*33074622*
 33074622

Clinical Review Report: Upadacitinib (Rinvoq): (AbbVie): Indication: For the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate

Clinical Review Report: Upadacitinib (Rinvoq): (AbbVie): Indication: For the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate-/-CADTH Common Drug Reviews 2020; ():

Rheumatoid arthritis (RA) is an autoimmune inflammatory disease that primarily affects the joints of the body. Characterized by acute and chronic inflammation of the synovium, or soft tissue surrounding the joints, patients are subject to severe pain, stiffness, and fatigue, all of which can affect a patient's ability to perform activities of daily living and overall health-related quality of life (HRQoL). Prolonged inflammation may lead to damage and destruction of the joints through erosion of the cartilage and bone and, consequently, disability and premature mortality. Other areas of the body may be affected as well, including the eyes, lungs, heart, or skin. It is estimated that about 1% of Canadians have the disease. Upadacitinib is a Janus kinase (JAK) inhibitor. JAK mediates the effects of cytokines and their production, thus JAK inhibitors may have more of a global effect on various cytokine production than do biologics, which tend to target specific cytokines. Upadacitinib is the third JAK inhibitor approved in Canada, the first being tofacitinib, followed by baricitinib, both of which were previously reviewed and issued recommendations by the CADTH Canadian Drug Expert Committee. The systematic review protocol for the current review was established before the granting of Notice of Compliance from Health Canada for upadacitinib. The objective is to perform a systematic review of the beneficial and harmful effects of upadacitinib 15 mg extended-release tablets for once daily administration for the treatment of moderate to severe RA in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate or other conventional synthetic DMARDs (csDMARDs).

*32598111*
 32598111

Pharmacoeconomic Review Report: Upadacitinib (Rinvoq): (AbbVie): Indication: For the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate

Pharmacoeconomic Review Report: Upadacitinib (Rinvoq): (AbbVie): Indication: For the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate-/-CADTH Common Drug Reviews 2020; ():

Upadacitinib is a Janus kinase (JAK) inhibitor (also referred to as a targeted synthetic disease-modifying antirheumatic drug [tsDMARD] in practice), indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. The recommended dose of upadacitinib is 15 mg daily as monotherapy or combination therapy. At the sponsor-submitted price of $48.68 per 15 mg tablet, the annual treatment cost is $17,770. The sponsor submitted a cost-utility analysis that considered upadacitinib as initial treatment for moderate-to-severe RA after an inadequate response or are intolerant to either a conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR population) or a biologic disease-modifying antirheumatic drug (bDMARD-IR population). The sponsor's analysis was conducted from the perspective of a Canadian publicly funded health care payer over a five-year time horizon. Comparators included csDMARDs, bDMARDs, and other tsDMARDs. The pharmacoeconomic submission was based on a Markov model, where treatment response was evaluated using the American College of Rheumatology (ACR) response criteria. The model was composed of four main health states after the evaluation of initial treatment: 20% improvement in ACR criteria (ACR20); 50% improvement in ACR criteria (ACR50); 70% improvement in ACR criteria (ACR70); and lack of adequate treatment response (i.e., did not achieve minimum of ACR20). Patients who had an inadequate response or discontinued treatment owing to a serious adverse event (SAE) could receive a subsequent treatment and transition to any of the previously mentioned health states. If an adequate response was not achieved on subsequent treatment, patients received best supportive care (BSC), the prior therapy (bDMARD or tsDMARD) which patients achieved the best treatment effect. A sponsor-commissioned network meta-analysis (NMA) was submitted and informed the comparative ACR response at weeks 12 and 24. SAEs were incorporated on the basis of an NMA previously conducted by CADTH4 and updated to include upadacitinib and other missing comparators. Long-term discontinuation was included in the model owing to a loss of treatment effect over time. Health state utility values for ACR response and nonresponse were based on Health Assessment Questionnaire (HAQ) scores mapped to the Health Utility Index 3 (HUI-3) tool. In the sponsor's base case, upadacitinib + csDMARD was associated with both higher total costs and quality-adjusted life-years (QALYs) when compared to csDMARD monotherapy in both target populations. In the csDMARD-IR population, the preferred option is csDMARD monotherapy if the decision-maker's willingness to pay (WTP) is below $74,979 per QALY, infliximab 3 mg/kg + csDMARD if the decision-maker's WTP is between $74,979 and $80,897 per QALY, etanercept 50 mg + csDMARD if the decision-maker's WTP is between $80,897 and $107,659 per QALY, and upadacitinib + csDMARD if the decision-maker's WTP is more than $107,659 per QALY. In the bDMARD-IR population, the preferred option is a csDMARD if the decision-maker's WTP is below $104,193 per QALY, upadacitinib + csDMARD if the decision-maker's WTP is between $104,193 and $303,516 per QALY, and tocilizumab 8 mg/kg + csDMARD if the decision-maker's WTP is more than $303,516 per QALY. Other treatments were dominated or extendedly dominated.

*32598110*
 32598110

Evidence review for psychoacoustic measures: Tinnitus: assessment and management: Evidence review I

Evidence review for psychoacoustic measures: Tinnitus: assessment and management: Evidence review I-/- 2020; ():

Psychoacoustic measures of tinnitus have sometimes been used historically as part of a comprehensive assessment of the experience of tinnitus alongside otoscopy and pure tone audiometry. Psychoacoustic measures commonly include tinnitus pitch and loudness matching, minimal masking levels and residual inhibition and have been used as part of the evaluation of a person's tinnitus, forming a baseline measure against which to monitor the success of the management plan. Pitch matching has been used to establish the frequency characteristics of tinnitus, which is then adjusted in intensity to match the loudness of the tinnitus. Minimal masking levels have been used as the lowest level at which the tinnitus can be masked by a stimulus, often narrow band noise, broad band noise or a pure tone. Finally, residual inhibition is a phenomenon whereby tinnitus is temporarily reduced after the presentation of masking noise for a short period of time. However, the reliability, validity and usefulness of the clinical data obtained from these psychoacoustic tests are questionable and there are no standardised protocols. This review was therefore carried out to inform recommendations about whether psychoacoustic measurements are clinically and cost effective for assessing tinnitus.

*32437112*
 32437112

Evidence review for patient information: Tinnitus: assessment and management: Evidence review B

Evidence review for patient information: Tinnitus: assessment and management: Evidence review B-/- 2020; ():

Information and advice on the causes of tinnitus and the range of interventions to successfully manage tinnitus, including self-management, may not be easy to access in an appropriate format for all people with tinnitus and their carers. On the whole, the general public has poor knowledge of tinnitus, and in particular people with tinnitus and their families and carers have a need for more information to help them cope with the condition. Those with tinnitus are sometimes given inaccurate or unhelpful information, which can have a negative impact on their ability to live well with tinnitus. Those who seek support also may not be given the information they need in order to make informed choices about the possible interventions appropriate for them or the information might not be tailored to their specific needs. Early provision of relevant information may help the person manage tinnitus better and prevent tinnitus from being intractable and/or distressing. Provision of information and support is inconsistent throughout the UK. Healthcare professionals may provide information and advice but this is not universally available or standardised. This review was carried out to inform recommendations about the information and advice needs of people with tinnitus and their families and carers. This information can help them adjust to having tinnitus and learn to manage it either through self-management or accessing further interventions. Appropriate and relevant information is an integral part of support and a review on support for people with tinnitus (sometimes known as counselling) can be found in evidence review A.

*32437111*
 32437111

Evidence review for combinations of management strategies: Tinnitus: assessment and management: Evidence review P

Evidence review for combinations of management strategies: Tinnitus: assessment and management: Evidence review P-/- 2020; ():

Practice across the UK varies greatly for people with tinnitus. Commonly, treatment strategies include sound therapy, psychological therapies, counselling/ tinnitus support and amplification devices. Some people are offered only one of these approaches, while others are offered more than one or a combination of approaches. Some people with tinnitus find that using sound to manage tinnitus is helpful, while others report that being able to respond differently to their tinnitus is important to them. How decisions are made for people accessing a particular approach also varies greatly, with some people not being actively involved in the decisions about their care. For the purpose of this guideline, the term 'tinnitus support' is favoured over 'tinnitus counselling' and is defined as an interactive process between the individual with tinnitus and healthcare professional. Within this, the concerns and needs of the individual are identified and explored, including difficulties associated with tinnitus and the individual's understanding of the emotions related to tinnitus. As part of this process, delivery of information about tinnitus involves a two-way discussion promoting an understanding of the tinnitus. Then, a management plan can be developed that is tailored to the individual. The individual is supported to understand why suggested strategies may be helpful and how they can go about putting these in to place. As the tinnitus support is individually focused, consideration is made with regard to the needs, age and ability of the individual to ensure that all information is made accessible to them. Where other needs are identified, for example mental health needs, the person with tinnitus may also benefit from being to be referred to other relevant services. The purpose of this review is to determine the effectiveness of using a combination of approaches. Separate reviews look at the clinical and cost effectiveness of amplification devices and sound therapy (evidence review M), psychological therapy (evidence review L) and tinnitus support (evidence review A) alone.

*32437110*
 32437110

Beyond PubMed : called unfree



Seattle nurses prove 'unity is power'.

1199 News 1983; 18 (9): 18-9

*10263171*
 10263171

What the National Hospital Union means to its members.

1199 News 1983; 18 (9): 12-5

*10263170*
 10263170

Chinatown Health Clinic.

1199 News 1983; 18 (10): 29-31

*10262725*
 10262725

600 RNs gain higher rates in Lenox Hill pact.

1199 News 1983; 18 (3): 30

*10259008*
 10259008

Michigan community joins striking nurses on patient care issues.

1199 News 1983; 18 (3): 12-3

*10259007*
 10259007

Reagan's new attack on health care for the poor.

1199 News 1983; 18 (7): 4

*10310229*
 10310229

Organizing state hospital workers in West Virginia.

1199 News 1983; 18 (1): 7-11

*10259944*
 10259944

N.Y. hospitals say 'no' to nuclear war plan.

1199 News 1983; 18 (1): 6

*10259943*
 10259943

The emotional cost of Reaganomics.

1199 News 1983; 18 (1): 19

*10259942*
 10259942

Social workers under fire.

1199 News 1983; 18 (2): 15-7

*10259945*
 10259945

The National Hospital Union in 1983. Ten years of struggle, ten years of progress.

1199 News 1983; 18 (8): 15-20

*10262226*
 10262226

3,200 Massachusetts professionals choose 1199.

1199 News 1983; 18 (4): 3-7

*10259947*
 10259947

National union seeks health coverage for unemployed.

1199 News 1983; 18 (4): 11

*10259946*
 10259946

Cancer and hospital workers.

1199 News 1982; 17 (9): 7-9

*10259941*
 10259941

1199 to Reagan: 'don't gut hospital standards'.

1199 News 1982; 17 (9): 19

*10259940*
 10259940

9,000 New York home care workers win first contract.

1199 News 1982; 17 (9): 10-1

*10259939*
 10259939

St. Barnabas nurses win it.

1199 News 1982; 17 (10): 9-10

*10259938*
 10259938

New nursing trends threaten LPNs' future.

1199 News 1982; 17 (10): 24-5

*10259937*
 10259937

While health services are slashed . . . now hospitals can use Medicare funds for union-busting.

1199 News 1982; 17 (5): 9

*10298512*
 10298512

Hospitals warned against Social Security pull-out.

1199 News 1982; 17 (5): 6-7

*10255122*
 10255122

Leon Davis: his passion for justice built a union.

1199 News 1982; 17 (3): 3-13

*10315953*
 10315953

New York contract: united membership plus strong new leadership equals victory.

1199 News 1982; 17 (8): 3-11

*10256500*
 10256500

Health care in crisis.

1199 News 1982; 17 (8): 23-6

*10256499*
 10256499

A first in day care for 1199ers' kids.

1199 News 1982; 17 (8): 15

*10256498*
 10256498

A hospital director recalls 22 years with 1199. Interview by Nancy Stiefel.

1199 News 1981; 16 (9): 23

*10252183*
 10252183

Connecticut Health Care Associates joins 1199.

1199 News 1981; 16 (10): 16-7

*10253003*
 10253003

These Southern hospital workers have left the plantation forever.

1199 News 1981; 16 (5): 8-9

*10251311*
 10251311

Long struggle brings 1199 contract for nurses in New Mexico.

1199 News 1981; 16 (3): 4-5

*10250584*
 10250584

The saints come marching in: victories at St. Clare's in New York are latest in series of 1199 wins at Catholic hospitals.

1199 News 1981; 16 (3): 3

*10250583*
 10250583

Physicians assistants: new 1199ers medical pioneers.

1199 News 1981; 16 (6): 24-5

*10314533*
 10314533

The service employees: a sister union that's a lot like us.

1199 News 1981; 16 (6): 7-10

*10251313*
 10251313

RWDSU and SEIU agree to merge.

1199 News 1981; 16 (6): 12-3

*10251312*
 10251312

Connecticut: big gains for 2,000 nursing home 1199ers.

1199 News 1981; 16 (1): 23-5

*10249600*
 10249600

King's Daughters' contract sets pace for Kentucky hospitals.

1199 News 1981; 16 (1): 13

*10249599*
 10249599

Government shouldn't reimburse union-busters.

1199 News 1981; 16 (2): 6

*10298107*
 10298107

Contract gains for 12,500 members.

1199 News 1981; 16 (8): 3-7

*10252182*
 10252182

2,000 Michigan LPNs affiliate with 1199.

1199 News 1981; 16 (8): 15-7

*10252181*
 10252181

Why nurses leave nursing.

1199 News 1981; 16 (4): 24-5

*10250585*
 10250585

Victory at St. Barnabas.

1199 News 1980; 15 (9): 3-5

*10247898*
 10247898

We're making more money than we used to, but we're living worse.

1199 News 1980; 15 (5): 6-7

*10247895*
 10247895

New York's League negotiations begin.

1199 News 1980; 15 (5): 3-5

*10247894*
 10247894

Hospital election win caps 12-year campaign.

1199 News 1980; 15 (3): 6

*10246674*
 10246674

Georgetown University Hospital goes 1199E.

1199 News 1980; 15 (3): 4-5

*10246673*
 10246673

Power for RNs through 1199.

1199 News 1980; 15 (3): 16-7

*10246672*
 10246672

New Hampshire RNs go 1199.

1199 News 1980; 15 (6): 15-7

*10246675*
 10246675

Why Syosset Hospital is sick.

1199 News 1980; 15 (7): 24-5

*10247496*
 10247496

A new voice in the hospital.

1199 News 1980; 15 (7): 16-8

*10247495*
 10247495

Patient care: the health care employee's responsibility.

1199 News 1980; 15 (1): 25-9

*10246126*
 10246126

Life in the hospitals in a new musical revue: Take Care.

1199 News 1980; 15 (2): 5-7

*10246127*
 10246127

Equal pay for women workers.

1199 News 1980; 15 (8): 8-9

*10247897*
 10247897

New minimum wage rates for League 1199ers.

1199 News 1980; 15 (8): 6-7

*10247896*
 10247896

A mother and her child: grievance wins leave so 1199er can be at ailing son's bedside.

1199 News 1979; 14 (10): 32

*10246669*
 10246669

1199s scholarship program.

1199 News 1979; 14 (10): 31

*10246668*
 10246668

Brooklyn Jewish: how the fight for a community's health was won.

1199 News 1979; 14 (11): 3-5

*10246670*
 10246670

New York 1199ers tell Mayor Koch: hands off voluntary hospitals.

1199 News 1979; 14 (6): 4-5

*10246671*
 10246671

Women in health care: today's goal is strength through unity.

1199 News 1979; 14 (7): 15-7

*10245788*
 10245788

A good beginning: 20 years in the hospitals.

1199 News 1979; 14 (12): 2-48

*10297812*
 10297812

Vollkorn fur die Fuhrer: zur geschichte der Vollkornbrotpolitik im "Dritten Reich".

1999 Z Sozial 20 21 Jhd 2001; 16 (1): 91-128

*20017268*
 20017268

Auf der spur von Medizinverbrechen: Keith Mant (1919-2000) und sein debut als forensischer pathologe.

1999 Z Sozial 20 21 Jhd 2001; 16 (1): 129-39

*20017267*
 20017267

Wie erarbeitet man sich einen naturlichen Korper? Korpernormalisierung in der Deutschen Nacktkulturbewegung um 1900.

1999 Z Sozial 20 21 Jhd 1999; 14 (2): 86-109

*22590769*
 22590769

Wehrmacht und Prostitution: zur Reglementierung der Geschlechterbeziehungen durch die Deutsche Militarverwaltung im besetzten Frankreich 1940-1944.

1999 Z Sozial 20 21 Jhd 1999; 14 (2): 35-55

*22590767*
 22590767

Eine Sowjetische Liste der Personenverluste im Zweiten Weltkrieg von 1946.

1999 Z Sozial 20 21 Jhd 1999; 14 (1): 126-33

*22590766*
 22590766

Diskurse und Erfahrungen: ein Ruckblick auf die Korpergeschichte der neunziger Jahre.

1999 Z Sozial 20 21 Jhd 1999; 14 (2): 142-60

*22590763*
 22590763

Arbeitsmarktpolitik, Migration und Rechtliche Stigmatisierung von fremden: von Weimar nach Bonn.

1999 Z Sozial 20 21 Jhd 1999; 14 (1): 92-125

*22590762*
 22590762

The child and the daemon: Mozart and deep play.

19th Century Music 2001; 25 (2-3): 91-107

*20217971*
 20217971

Ben Pimlott Memorial Lecture 2018The Women's Suffrage Movement in the Balfour Family.

20 Century Br Hist 2019; 30 (3): 299-320

Given on the centenary of women's suffrage, this lecture explores the tensions and conflicts the claim for the vote raised among elite women already enmeshed in parliamentary and political circles. Drawing on the unbuttoned and sometimes angry correspondence among A.J. Balfour's suffragist sisters-in-law Lady Frances Balfour and Lady Betty Balfour, Frances' collaborator (and suffragist leader) Millicent Fawcett, Lady Betty's militant suffragette sister Lady Constance Lytton, and their old friend (and wife of the anti-suffragist Prime Minister) Margot Asquith, it explores the appeal but also the costs of this democratic claim for such "incorporated" women - and explains why some nevertheless supported it.

*31330031*
 31330031

TCBH Duncan Tanner Essay Prize Winner 2018 Financing the Information Age: London TeleCity, the Legacy of IT-82, and the Selling of British Telecom.

20 Century Br Hist 2019; 30 (3): 424-446

This article is a history of the privatization of British Telecom. BT's privatization occupies a central position in histories of Thatcherism as a pivotal moment in Thatcherism's ideological focus on popular capitalism. These histories, however, overlook the important intersection of financial institutions and information technology policy in shaping BT's privatization. Financial institutions in the City of London formed a lobbying group, the City Telecommunications Committee, that pressured for BT's privatization and secured preferential treatment for the City from BT, ending a decades-long policy of uniform telecommunications services across Britain. Margaret Thatcher's government positioned BT's privatization as central to the success of two of Britain's information industries, electronics manufacturing and the City of London. Her government also cast BT's privatization as essential to an 'information revolution' that, through personal, networked computing, would further personal freedom and free markets. BT's privatization thus performed two important and related functions. First, it oriented Britain's telecommunications network to the City of London's needs, and secondly, it enacted an 'information revolution' that was portrayed as essential to the success of the City of London and British electronics. I label this fusion of City finance, neoliberal politics, and British telecommunications the 'London ideology', and this ideology shaped the broadly-held assumption that privatizing telecommunications was essential to reaching the 'information age'.

*31157870*
 31157870

'You Can't Dismiss that as Being Less Happy, You See it is Different'. Sexual Counselling in 1950s England.

20 Century Br Hist 2019; 30 (3): 375-398

This article uses the audio recordings of sexual counselling sessions carried out by Dr Joan Malleson, a birth control activist and committed family planning doctor in the early 1950s, which are held at the Wellcome Library in London as a case study to explore the ways Malleson and the patients mobilised emotions for respectively managing sexual problems and expressing what they understood as constituting a 'good sexuality' in postwar Britain. The article contains two interrelated arguments. First, it argues that Malleson used a psychological framework to inform her clinical work. She resorted to an emotion-based therapy that linked sexual difficulties with unconscious, repressed feelings rooted in past events. In so doing, Malleson actively helped to produce a new form of sexual subjectivity where individuals were encouraged to express their feelings and emotions, breaking with the traditional culture of emotional control and restraint that characterized British society up until the fifties. Second, I argue that not only Malleson but also her patients relied on emotions. The performance of mainly negative emotions reveals what they perceived as the 'normal' and sexual 'ideal'. Sexual therapy sessions reflected the seemingly changing nature of the self towards a more emotionally aware and open one that adopted both the language of emotions and that of popular psychology to articulate his or her sexual difficulties.

*30986822*
 30986822

Deindustrialization, the Linwood Car Plant and Scotland's Political Divergence from England in the 1960s and 1970s.

20 Century Br Hist 2019; 30 (3): 399-423

Scotland's political divergence from England is a key theme in late twentieth century British history. Typically seen in terms of the post-1979 Thatcher effect, this in fact developed over a longer timeframe, rooted in industrial changes revealed by analysis of the Linwood car plant in Renfrewshire. Conservatism and Unionism was an eminent political force in Scotland in the 1940s and 1950s. But in all general elections from 1959 onwards the vote share of Conservative and Unionist candidates was lower in Scotland than in England. From the late 1960s onwards there were also ambitions for constitutional change. This article breaks new conceptual and empirical ground by relating these important markers of political divergence to popular understanding among Scottish workers of deindustrialization. A Thompsonian moral economy framework is deployed. Expectations were elevated by industrial restructuring from the 1950s, with workers exchanging jobs in the staples for a better future in assembly goods. Labour governments earned a reputation in Scotland as better managers of this process than Conservative governments. The 1979 general election showed that Labourism was growing in popularity in Scotland just as its appeal faded in England. At Linwood moral economy expectations were compromised, chiefly by intermittent redundancy and recurrent threat of closure, which was averted in 1975 by Labour government intervention. When the plant was shut in 1981 criticisms of UK political-constitutional structures and Conservativism were intensified.

*30897624*
 30897624

"The British Soldier is no Bolshevik": The British Army, Discipline, and the Demobilization Strikes of 1919.

20 Century Br Hist 2019; 30 (3): 321-346

This article considers the breakdown in discipline in the British Army which occurred in Britain and on the Western Front during the process of demobilization at the end of the First World War. Many soldiers, retained in the army immediately after the Armistice, went on strike, and some formed elected committees, demanding their swifter return to civilian life. Their perception was that the existing demobilization system was unjust, and men were soon organized by those more politically conscious members of the armed forces who had enlisted for the duration of the war. At one stage in January 1919, over 50,000 soldiers were out on strike, a fact that was of great concern to the British civilian and military authorities who miscalculated the risk posed by soldiers. Spurred on by many elements of the press, especially the Daily Mail and Daily Herald, who both fanned and dampened the flames of discontent, soldiers' discipline broke down, demonstrating that the patriotism which had for so long kept them in line could only extend so far. Though senior members of the government, principally Winston Churchill, and the military, especially Douglas Haig and Henry Wilson, were genuinely concerned that Bolshevism had 'infected' the army, or, at the very least, the army had been unionized, their fears were not realized. The article examines the government's strategy regarding demobilization, its efforts to assess the risk of politicization and manage the press, and its responses to these waves of strikes, arguing that, essentially, these soldiers were civilians first and simply wanted to return home, though, in the post-war political climate, government fears were very real.

*30544173*
 30544173

'Co-operation and Communism cannot work side by side': Organized Consumers and the Early Cold War in Britain.

20 Century Br Hist 2019; 30 (3): 347-374

This article contributes to a better understanding of labour anti-communism in Britain through an exploration of the evolution of ideas and attitudes within the co-operative movement during the early Cold War. It demonstrates that the period witnessed an increasingly rigid separation of co-operation from communism and argues that this separation made it harder for activists within the co-operative movement to imagine a total or utopian alternative to capitalism. Drawing particularly on a close reading of the co-operative press as well as other sources, the study is divided into three main parts. The first section discusses sympathy among co-operators for the achievements of the Soviet Union, which increased during the war against fascism. The article then moves on to consider the continuing dialogue between British co-operators and their counterparts in European communist states and how international tensions shaped co-operators' views. The final major section explores the hardening of attitude towards communism after Marshall Aid was declared in June 1947, and underlines the role played by figures such as A. V. Alexander and Jack Bailey who worked with the Information Research Department at the Foreign Office to spread anti-communism within the movement. The conclusion reflects, more speculatively, on what implications this shift may have had for the medium and long-term decline of co-operation and the hegemony of capitalist consumerism post-war.

*29618059*
 29618059

Environmental History and New Directions in Modern British Historiography.

20 Century Br Hist 2019; 30 (3): 447-456

*29474706*
 29474706

A 'Radical Project': Youth Culture, Leisure, and Politics in 1980s Sheffield.

20 Century Br Hist 2019; ():

The Leadmill, a cooperative arts centre and nightclub in Sheffield, opened in 1980. The venue sought to provide an accessible leisure space for the economically and socially marginalized, and received funding for this from Sheffield City Council. Focusing on the cultural policies of the new urban left Labour Council in Sheffield during the 1980s, this article explores the relationship between Sheffield City Council and the Leadmill. It builds on recent scholarship on the 1980s that has sought to look beyond Thatcherism as an explanation for the decade, and sheds light on the everyday experiences of living through this period. This article argues for the reinvigoration of local history, and demonstrates that an exploration of a site of community leisure unveils cooperation and engagement between groups with disparate and contradicting aims. It tells a different story of the 1980s, one that recognizes how Thatcherism allowed and in some cases enabled the creation of spaces within which its critics could thrive. It shows how a range of political dialogues were present in shaping the policies of local government, and how the longer tradition of state and market interaction was shaped by the specific social, economic, and political contexts of the decade. Above all, it challenges presentations of the 1980s that favour the hegemonic power of Thatcherism and the decade as one of the triumph of individualism.

*30859230*
 30859230

Socialist Television Drama, Newspaper Critics and the Battle of Ideas During the Crisis of Britain's Post-War Settlement.

20 Century Br Hist 2019; ():

Due to the difficult methodological issues it presents, political historians are wary of using television - the most important mass medium of the later twentieth century - as a means of exploring vernacular political thinking. Attempting to show how television audiences were encouraged to think politically, the article outlines a method generated through an engagement with the work of disciplines beyond history, to help political historians more systematically assess the medium's popular impact. The article takes as its case study Britain during the 1970s, one of the most ideologically contested periods in the country's history. It analyses how television critics employed by the Daily Mirror and Daily Express encouraged their millions of readers to respond to the dramas of socialist playwrights Jim Allen and Trevor Griffiths, thereby giving historians an insight into the shape of those conversations spawned by their work, such private dialogues being the place where the full political meaning of television was ultimately created.

*30859211*
 30859211

Labour Activism and the Political Self in Inter-War Working-Class Women's Politics.

20 Century Br Hist 2019; 30 (1): 29-52

This article explores working-class women's experiences of political activism in the Labour Party in the 1930s. The article focuses upon the relationships formed with leaders, the bonds with fellow women, and the emotional fulfilment politics could bring, rather than considering the policies and campaigns which drew women into the party. It suggests how working-class women performed a political self which was shaped by but distinctive from a domestic self. Official political party materials from across Britain are drawn upon to uncover how working-class women in the years after equal franchise was won carved out a political space and the meanings of activism. Party members' private and public portrayals of women's activism are considered. Although the focus is upon working-class women's political experiences, the conclusions drawn here have implications for how the creation of a political self can be considered in studies of other political parties and voluntary organizations.

*30541119*
 30541119

Splinters: Cross-Dressing Ex-Servicemen on the Interwar Stage.

20 Century Br Hist 2019; 30 (1): 1-28

This article will examine how a series of theatrical shows which starred casts of cross-dressing ex-servicemen achieved critical and commercial popularity in interwar Britain despite increased cultural anxieties about the links between gender variance and transgressive acts, behaviours, and categories of identity. Prior to this study, historians have researched wartime concert parties where servicemen cross-dressed for each other's entertainment, but scant attention has been given to the popular phenomenon of ex-servicemen who performed cross-dressing revues for the general public. Staging revues on the home front exposed cross-dressing ex-servicemen to new forms of spectatorship: the theatregoing public, arts criticism in the press, and state censorship. This article will analyse these dynamics for the first time through an investigation of the First World War troupe Les Rouges et Noirs, who popularized the subgenre of veterans' cross-dressing revues with their debut production Splinters (1918). Critics commended the company's contribution to the war effort while also lauding the troupe for their entertainment value and 'bewitching' feminine mimicry. Some observers, like the Lord Chamberlain, found Les Rouges' cross-dressing troubling, but these views were in the minority and did not seriously hinder the performers' success. When carried out temporarily in a performative setting by artists who presented a skilful and beguiling representation of femininity, and whose status as ex-servicemen helped to dispel suspicions of immorality, cross-dressing could be a source of great pleasure, even as it constituted a source of cultural anxiety in other contexts.

*30380103*
 30380103

King Caz: Cazenove, Thatcherism, and the 1980s financial revolution.

20 Century Br Hist 2019; 30 (1): 108-131

This article shows how elite stockbrokers Cazenove and Co. responded to the 'Big Bang' deregulation of the financial sector in 1986, using social networks and inherited practices to navigate an ostensibly technical and modernizing revolution. The Thatcher administration's reform of the London Stock Exchange was an economic enterprise intended to end restrictive practices and open the City to competition. A more open meritocratic financial sector marked the 'death of gentlemanly capitalism' and coalesced with a political agenda for entrepreneurialism and popular capitalism. Yet this case study shows how Cazenove's culture drove its strategy, that privilege and hierarchy were sustained by influential cross-sector networks, and that there was resistance to change, even though technological change and new financial instruments were embraced as part of a strategy which mixed innovation with tradition. Essentially, elite networks persisted in the 1980s deregulated economy, as established relationships were used to optimum effect and became more important after Big Bang. A more mutually supportive relationship between finance and industry than has hitherto been imagined is also demonstrated. By showing how a modernizing revolution was navigated using social networks and traditions, this article restores the role of culture to financial history. It also contributes to a body of work in twentieth-century British history which challenges the perception that neoliberal ideas were consistently applied under Thatcherism and complicates the notion of a coherent Thatcherite project.

*30107594*
 30107594

Stateless Persons, Eligible Citizens and Protected Places: The British Nationality Act in Vanuatu.

20 Century Br Hist 2019; 30 (1): 53-80

The British Nationality Act (BNA) of 1948 was designed to provide a form of supranational citizenship to accommodate the separate nationality provisions that were beginning to proliferate as a result of constitutional change within the late empire, decolonization and the formation of the Commonwealth. Under the provisions of the BNA, members of the Commonwealth would continue to be unified by transnational forms of citizenship, at least in principle. The Act aimed to cover every political arrangement conceivable in the late empire and early Commonwealth and contributed to the transformation of Great Britain into a multicultural society, by providing the legal vehicle for immigration into the UK in the second half of the twentieth century. However, the BNA had its limits. It could not be applied to territories characterized by constitutional exceptionalism and jurisdictional hybridity. In the Condominium of the New Hebrides, jointly governed by France and Great Britain from 1906 to 1980, the majority of the indigenous population were unable to benefit from the BNA, despite efforts to extend its coverage in all eligible territories. As part of the condominium agreement, the indigenous population were ineligible for any form of citizenship-British, French or New Hebridean-and remained stateless until independence as the Republic of Vanuatu in 1980. This article examines the relationship between indigenous statelessness and the BNA, exploring the implementation, interpretation and extent of the BNA in a territory characterized by constitutional hybridity, compromise and ambiguity. It argues that despite its emphasis on universal commonwealth citizenship, the BNA could not accommodate the diverse political, legal and constitutional diversity that characterized the Dominions, Crown Colonies, protectorates, protected states and condominia that had proliferated under imperial rule and whose legacies continued to inform the possibilities for decolonization and the politics of post-colonial citizenship making.

*30085310*
 30085310

Pension Funds and the Politics of Ownership in Britain, c. 1970-86.

20 Century Br Hist 2019; 30 (1): 81-107

The growth of occupational pensions in the post-war era transformed the pattern of capital ownership in Britain, as workers' collective retirement savings purchased a substantial share of the national economy. This article examines the response of the Labour and Conservative parties to this significant material change, and considers how it shaped their respective politics of ownership at the end of the post-war settlement. It demonstrates that Labour and the trade union movement recognized occupational pension funds as a new form of social ownership but had to reconcile their desire to give pension scheme-members direct control over their investments with a broader belief that the funds needed be used for a state-coordinated revitalization of the industrial economy. Meanwhile, the Conservative Party's initial enthusiasm for occupational pensions, which it championed for helping to create a 'property-owning democracy', was challenged by a radical neoliberal critique in the early 1980s that sought to dismantle pension funds and to individualize investment. The findings in the article assert the need for historians to situate the politics of the tumultuous 1970s and 1980s in the context of the substantial economic and social changes that had taken place during the post-war decades. These changes often created opportunities to formulate new policies and political agendas, but they also served to highlight deeper tensions within the ideologies of the main political parties.

*29688553*
 29688553

'Action Not Words': The Conservative Party, Public Opinion and 'Scientific' Politics, c.1945-70.

20 Century Br Hist 2019; ():

From the late 1950s, Conservative research and policy thinkers underwent a conscious intellectual adjustment, which had profound implications for how the party conceived the relationship between politicians and the public during Edward Heath's period as Conservative leader after 1965. In response to contemporaneous debates regarding 'modernization', and as a result of their engagement with the emergent social sciences, a new generation of Conservatives tended to repudiate the party's traditional preference for idealist and organicist philosophical assumptions in favour of a rationalistic approach to political administration. Their preoccupation with economic management was concomitant of their loss of faith in the formative role of rhetorical and moral appeals in shaping public opinion. This article, by focusing on debates within the party's research and political apparatus-the Conservative Research Department, the Conservative Political Centre and Swinton College-will contend that, far from being the last gasp of a post-war consensual Conservatism, Heath's period as leader marked a relatively unique period in the party's history, in which the conception of the nature of political leadership held by those at the top of the party differed from the conception held by both their predecessors and successors.

*31236567*
 31236567

The Trial of Convoy PQ17 and the Royal Navy in Post-War British Cultural Memory.

20 Century Br Hist 2019; ():

This article explores the 1970 case of Broome v. Cassell & Co. in which an elderly wartime naval officer was awarded unprecedented damages for defamation in David Irving's account of the sinking of wartime Allied convoy PQ17 in 1942. The article examines the discourses and images deployed in this landmark British libel action, as a means of analysing how cultural memories of convoy PQ17 and the wartime Royal Navy were shaped and transmitted in post-war Britain. It is argued here that the trial offers a prism through which to explore wider anxieties that the generation who fought the Second World War held during the late 1960s. It maps how contemporary generational tensions, fears of national decline, and concerns about distorted cultural representations of war in Britain were embedded into the trial. This libel case thus became invested with considerable cultural significance among an ageing community of wartime survivors who were intent upon safeguarding wider memories of 'their' war.

*31230077*
 31230077

Feminism and the Politics of Prostitution in King's Cross in the 1980s.

20 Century Br Hist 2019; 30 (2): 231-263

In the 1980s, prostitution resurfaced as the object of feminist politics as second-wave activists grappled with Thatcherism, prostitute rights, tenant activism, anti-violence movements, and changes in the street sex trade and in policing. These conflicting imperatives converged on King's Cross, London. Events in King's Cross highlight some general trends, especially shifts in policing and in the geographic dispersal of the street sex trade. King's Cross also possessed singular features. It was the epicentre of street prostitution in London and the destination for hundreds of northern women migrating to the metropolis to sell sex. Intensified policing of the street trade provoked a heated neighbourhood dispute between council tenants and a media-savvy prostitute rights group. The year 1982 also marked a new configuration in local politics: the control of Camden Council by Labour Left and the formation of the Camden Women's Committee. In this challenging environment, newly elected municipal feminists in Camden set out to devise a feminist practice around prostitution. They found themselves embroiled in local disputes over public space, gender justice, policing, municipal progressivism, and resident action.

*31032861*
 31032861

Erratum.

20 Century Br Hist 2019; 30 (2): 297

*30933269*
 30933269

Toffee Men, Travelling Drapers and Black-Market Perfumers-South Asian Networks of Petty Trade in Early Twentieth Century Britain.

20 Century Br Hist 2019; 30 (2): 145-173

Selling small wares, novelties, and affordable luxuries manufactured from artificial silk, the South Asian door-to-door pedlar or 'travelling draper', and his compatriot the 'Indian toffee man', were once fairly commonplace figures in British working-class life and the object of fond childhood recollections for many. Unfortunately, they have now largely drifted from popular memory, having left little trace in the historical record. However, this article's reconstruction of their lives offers a new perspective on the pivotal role inter-racial social networks played in pioneering South Asian immigration, settlement, and trade in Britain. New research into this pre-Partition, pre-Windrush immigration, particularly in and around the English industrial city of Sheffield, provides a more detailed and more nuanced understanding of their quotidian experience, their relationship to British society, and their reception by the working-class neighbourhoods within which they lived and plied their trade. The article emphasizes the men's enduring sense of agency and economic autonomy, despite the attempts of various departments of state to prevent them from exercising their right, as British subjects, to live and work in Britain.

*30879062*
 30879062

'Secret Lists and Sanctions': The Blacklisting of the John Lewis Partnership and the Politics of Pay in 1970s Britain.

20 Century Br Hist 2019; 30 (2): 205-230

In 1977, the John Lewis Partnership (JLP) was blacklisted for breaching the Labour government's pay controls under the Social Contract. As the Callaghan administration struggled to establish economic credibility, extending its reach into the private sector emerged as a political priority. JLP became a test case of government resolve months before the Ford strike of autumn 1978 that ushered in the Winter of Discontent. This article uses JLP records to create a more nuanced picture of the tensions, contestations, and vacillations of pay policy in the late 1970s. By doing so, gaps between policy conception and implementation emerge and intersect; both the business and the government faced constraints in implementing policy, despite powerful beliefs about the integrity of their actions. The article is not primarily a case study, however, and aims to contribute to broader debates. The constitutional significance, rather than the commercial impact, of government sanctions became a keynote of critique of JLP's blacklisting, suggesting that contemporaries recognized this was a confrontation of the political moment between the state and the private sector. By looking from a business's perspective, we also gain insight into how organizations approached, negotiated with, and responded to the government. Recovering the JLP blacklisting episode further shows how business archives offer great promise as resources for political history.

*30753661*
 30753661

A 'Mixture of Britannia and Boadicea': Dorothy Crisp's Conservatism and the Limits of Right-Wing Women's Political Activism, 1927-48.

20 Century Br Hist 2019; 30 (2): 174-204

Dorothy Crisp is known for being the militant Chairman of the British Housewives League (BHL) after the Second World War, but historians have failed to recognize that her views and actions were the culmination of over twenty years of right-wing journalism and political activism through which she tried to influence the Conservative Party. This article re-evaluates Crisp's Conservatism and her political career. It asks why such a powerful pro-Conservative female activist failed to secure a place within Conservative politics during the 1930s and the 1940s. In doing so, it shows that Crisp was not willing to conform to traditional gender roles inside the Party or the broader Conservative movement and that she was a vocal advocate for gender equality. It was the combination of her attitude towards women's issues and her older brand of imperialist, ultra-patriotic, anti-statist Conservatism that was unusual for a right-wing woman in this period. Crisp's views on women's issues did not fit the domesticity agenda of the BHL or that of the 'Tory women's tradition', which could not provide her with an opportunity to achieve her career goals. The article also explores how the Party handled challenges from independent right-wing activists, especially women, in a period when 'one-nation' Conservatism was dominant. It engages with recent debates about 'Conservative feminism' and argues that Crisp was also an important figure because she kept alive the model of the independent radical female Conservative, which would become the hallmark of Margaret Thatcher's politics a generation later.

*30452733*
 30452733

The 'Rainbow Alliance' or the Focus Group? Sexuality and Race in the Labour Party's Electoral Strategy, 1985-7.

20 Century Br Hist 2019; ():

In the 1980s, Labour struggled to respond to a hostile political context during a protracted period of opposition. Diverse figures claimed that the Left was suffering from a structural decline in a supposed 'traditional working class' voting base: contentions which only became more influential after the 1983 electoral catastrophe. Competing solutions were proffered-including building a 'rainbow alliance' informed by equalities politics, or appealing to a southern 'new working class'. The latter interpretation gained greater influence on Neil Kinnock's leadership. To fully understand why one triumphed over the other in the evolving strategy of the Labour Party, we should in part trace discourses, including contemporary 'loony Left' scandals. However, we must also recognize the importance of 'epistemological practice', which was crucial in shaping how political actors acquired knowledge and forged interpretations of the electorate. Focusing on the evolution of the epistemological practice of Kinnock's leadership team-in particular, their increasing reliance on qualitative opinion research techniques like focus groups to supplement quantitative attitudinal polling-helps explain why they became convinced that recent controversies involving race and sexuality were having acutely negative consequences for Labour nationally. This furnishes us with a deeper understanding of the relationship between grassroots and national Left-wing politics in the 1980s. It also illuminates Labour's cautious approach to equalities politics into the 1990s.

*31280311*
 31280311

'Race', Black Majority Churches, and the Rise of Ecumenical Multiculturalism in the 1970s.

20 Century Br Hist 2019; ():

At the beginning of the 1970s, relations between the historic British churches and the new black-led churches were usually non-existent or marked by prejudices or ambivalences. This article examines the emergence, development, and significance of a cross-cultural ecumenical dialogue sponsored by the British Council of Churches. It places this in a context of both growing white liberal interest in the 'multi-racial' society and the increasing public assertiveness of collective black Christian consciousness. In doing so, it contributes to our understandings of religious change in the twentieth century: both in terms of perceptions of 'secularization' and the complex relationship between Christianity and race relations in the decades after Windrush.

*31270540*
 31270540

Counterculture, Local Authorities and British Christianity at the Windsor and Watchfield Free Festivals (1972-5).

20 Century Br Hist 2019; ():

Four free pop festivals, held in Windsor and Watchfield in 1972-75, attracted significant public attention. This article discusses the aims and ideals of the festivalgoers, the confused reactions of the authorities, the ambivalence of the Anglican Church and the hostility of some conservative groups. We argue that the free festivals mark an important stage in the constitution of the counterculture and that they created a model which later pop festivals (in particular Glastonbury) attempt to emulate. We show that themes relating to a revival of the pilgrimage experience became important markers of this new type of event, shifting the emphasis from political protest to a memorialized and performative activism.

*30657967*
 30657967

First Aid and Voluntarism in England, 1945-85.

20 Century Br Hist 2019; ():

First aid was the focus of growing voluntary activity in the post-war decades. Despite the advent of the National Health Service in 1948, increased numbers of people volunteered to learn, teach, and administer first aid as concern about health and safety infiltrated new activities and arenas. In this article we use the example of the Voluntary Aid Societies (VAS, focusing in particular on St John Ambulance) to highlight continuities and change in the relationship between state and voluntary sector in health and welfare provision during the four decades after 1945. Though the state assumed vastly expanded health and welfare responsibilities after the war, the continuing vitality of the VAS suggests cultural continuities that the post-war welfare state did not eradicate. The article therefore builds on the insights of historians who argue that volunteering remained a vital component of British society across the later twentieth century, and that the state and voluntary sector were not mutually exclusive.

*30715547*
 30715547

The Limits of Power: Wind Energy, Orkney, and the Post-war British State.

20 Century Br Hist 2019; ():

This article identifies the environmental components of the limits of industrial nationalization between 1945 and 1956, and with it the spatial dimensions of state power, through a case study of wind power experiments on the Orkney islands. Technocratic and socialist principles drove efforts to supply electricity to all corners of the nation, but material and environmental factors limited success, especially in remote regions. The article considers the materiality of islandness and its effects on the application of national-scale energy policy and emergence of 'alternative' energy solutions, in light of James C. Scott's theory of high modernism as an ideology which emanated from centres of power to rural peripheries. It argues that an environmental lens produces new thinking on the spatial constructions of state in post-war Britain that recognizes the influence of geographical edges as materially and imaginatively capable of disrupting a narrative of one-way power emanating from the centre. Wind joins other natural forces able to exert agency in narratives of technological development and modernism, which augment our understanding of energy, nature, and nation.

*31377787*
 31377787

The Ben Pimlott Memorial Lecture 2017: The Geopolitical Is Personal: India, Britain, and American Foreign Correspondents in the 1930s and 1940s.

20 Century Br Hist 2018; 29 (3): 388-410

This lecture explores the shared terrain between the new international history and the history of emotions. In the summer and fall of 1942, American foreign correspondents played a key role in sparking a furore over British rule in India. Drawing on their own first-hand reporting from India, they depicted the British Empire as retrograde and abusive, a dangerous, destabilizing force and a threat to the post-war peace. Diagnosing what it called 'a new landslide of anti-British feeling', the British Ministry of Information spearheaded the formation of high-level, interdepartmental, secret committee charged with the task of figuring out how to reconcile Americans to the British Empire. What they found was that the job itself was impossible: a significant proportion of Americans 'whose views, they concluded, were driven in large measure by emotion' would not under any circumstances soften their opinions about the British Empire.

*29939371*
 29939371

TCBH Duncan Tanner Essay Prize Winner 2017: The 'Progress of a Slogan': Youth, Culture, and the Shaping of Everyday Political Languages in Late 1940s Britain.

20 Century Br Hist 2018; 29 (3): 435-458

In 1948, worried that young people would take full employment and the welfare state for granted, the Labour Party trialled a new slogan: 'Ask your Dad'. This slogan encouraged the young to learn about the hardships which their parents had experienced in the inter-war years, largely under Conservative governments. Using archived interviews and letters sent to the press, this article provides the first study of the popular reception of this slogan. Most people had not heard of this slogan, and most of those who had heard of the phrase showed no knowledge that it was associated with politics, turning instead to popular culture. Those who understood the slogan were not the passive conduits of their party's message; often, they reworked political ideas to fit their own memories. Because repeating slogans was associated with a lack of political independence, not listening to party politics could conceal an intense interest in creating political change-an attitude which was, apparently, pronounced amongst the young. This article uses these responses to suggest how political language was as much produced by ordinary people's memories and daily discussion, as it was something drawn from professional campaigners.

*29672746*
 29672746

The 'Conchie Corps': Conflict, Compromise and Conscientious Objection in the British Army, 1940-1945.

20 Century Br Hist 2018; 29 (3): 411-434

*29584901*
 29584901

'The Lights of the Electric Octopus Have Been Switched Off': Visual and Political Culture in Edwardian London.

20 Century Br Hist 2018; 29 (3): 331-356

This article reconstructs the visual culture of politics in Edwardian London through a study of the 1907 London County Council election. It moves beyond the memorable account given in Graham Wallas's Human Nature in Politics to examine the actors, especially associations and newspapers, that participated in the election. Drawing upon newspapers, election addresses, cartoon, leaflets, and posters, the article argues that Edwardian London was a prime site in the application of new media for political communication. It shows, however, that new modes of communication could co-exist with, and intensify, established forms of public politics. It reveals a highly knowing visual culture of politics through which issues of authenticity and identity were contested, and recasts understanding of a controversial and critical election.

*29244188*
 29244188

Commercial Heritage as Democratic Action: Historicizing the 'Save the Market' Campaigns in Bradford and Chesterfield, 1969-76.

20 Century Br Hist 2018; 29 (3): 459-484

This article argues that the traditional retail market-a ubiquitous commercial feature of British towns and cities-produced a particular strand of heritage politics in late 1960s and early 1970s Britain. In recovering the activists involved in two campaigns to 'save the market' from redevelopment-one unsuccessful campaign in Bradford and one successful campaign in Chesterfield-I make the case for thinking through local urban heritage movements in comparative terms, focusing on how place-based citizenship collided with a nascent, national 'anti-development' mood in the early 1970s. The campaigns in Bradford and Chesterfield defended the transhistorical 'publicness' of the retail market-its spatial centrality, its collective ownership, and its relief of town or city rates-as a critique of contemporary, undemocratic privatization of communal space. Combining the archives of civic amenity, community action, and heritage societies with subjective attitudes towards preservation and redevelopment found in local 'letters to the editor' pages, this article reads the market as one physical nexus where local 'politics' and 'publics' collided and permutated in early 1970s provincial Britain. This focus on the lived heritage of socio-economic place has bearing on public history, the history of urban social movements, and architecture and planning historiography.

*29237077*
 29237077

Seance Sitters, Ghost Hunters, Spiritualists, and Theosophists: Esoteric Belief and Practice in the British Parliamentary Labour Party, c1929-51.

20 Century Br Hist 2018; 29 (3): 357-387

This article explores esoteric identities and cultures in the British Parliamentary Labour Party c1929-51. The historiography of the Labour Party has tended to overemphasize the one-dimensional nature of ideological affiliation and identity amongst Labour Members of Parliament in this period along the lines of a rather simplistic left/right dichotomy. Moreover, some historians have suggested that after 1918 particular socialist traditions and currents had become marginalized or dissolved once the party had developed a clearly defined constitution and the experience of political power. The argument presented here is that a range of esoteric identities remained a feature of labour culture through to the general election of 1951 and beyond. Three currents highlight the complexity and fluidity of specific strands of labour/socialist identity; in particular, spiritualism, theosophy and belief in the supernormal and the fantastic. Spiritualism and esotericism attracted a range of Labour MPs and shaped their reaction to contemporary political problems and the purpose and direction of working-class politics. An examination of such individuals and beliefs raises some new questions and challenges existing assumptions relating to labour identities in mid-twentieth century Britain. Socialist spiritualists, ghost hunters, and theosophists viewed political identity, mobilization and practice as an activity that drew as much on the personal, the spiritual and 'other-worldly' as it did on the economic, social and material basis of society.

*29077961*
 29077961

Corrigendum.

20 Century Br Hist 2018; ():

*30295896*
 30295896

Family Politics: Campaigning for Child Benefits in the 1980s.

20 Century Br Hist 2018; ():

Child benefit was seen by some to encourage the sort of welfare dependency that the moralistic individualism of Thatcherism opposed. Yet, surprisingly, the benefit survived the Thatcher years. Its survival reveals the conundrum the Conservative party have had regarding benefits for the family and family policy more broadly. Neo-liberals were supportive of the family as a vehicle for reinforcing Conservative values. Yet, the late 1970s and 1980s were periods of social change where the traditional family of the Conservative imagination was breaking down and consequently 'family policy' became a key political theme. By emphasizing the utility of child benefit as being fair to families, rather than its role in poverty alleviation, the Child Poverty Action Group (CPAG) was able to draw on this increased concern. As a result, their campaigns to save child benefit profited from increased support from across Conservatism. In tracing the development of CPAG's campaign, this article will demonstrate the cautiousness of Conservatives, even in the neo-liberal era, to changing some aspects of social policy. It will also highlight the challenge changing family patterns posed to the male breadwinner model that had long been embedded within the welfare policy prescriptions of both main parties.

*30418661*
 30418661

On Tour with the Prince: Monarchy, Imperial Politics and Publicity in the Prince of Wales's Dominion Tours 1919-20.

20 Century Br Hist 2018; 29 (1): 25-57

The stage managers of ritual and the media transformed the British monarchy in the late-nineteenth and early-twentieth century, consolidating its image as splendid and popular and also as more accessible and quasi-democratic. Historians have emphasized that these processes of modernization largely began in Britain. This article locates the origins of democratized royal ritual in the white dominions, especially after 1918. Canada, Australia and New Zealand were political and cultural laboratories where royal advisors and British and dominion politicians launched experiments in the practice of progressive empire and innovatory styles of informal ceremonial, which had a long-term impact on imperial and later Commonwealth relations. Focusing on the Prince of Wales's early dominion tours, the article argues that though royal diplomacy followed earlier itineraries in efforts to consolidate the racialized British world, it also threw up new and unintended consequences. These registered the rapidly changing international order after the collapse of the European monarchies, together with the demands of the prince's own modernist personality. Faced with republican and socialist opposition in Australia and Canada, the touring prince was drawn into competing forms of nationalism, as dominion politicians and journalists embraced him as representing domestic aspirations for self-government and cultural recognition. It is argued that modern royalty personified by the Prince of Wales problematizes the history of twentieth-century public reputations defined by the culture of celebrity. The British monarchy was forced to confront both the constitutional claims of empire and the politics of dominion nationalism, as well as the pressures of international publicity.

*29481684*
 29481684

International Institutions and Domestic Reform: Equal Pay and British Membership in the European Economic Community.

20 Century Br Hist 2018; 29 (1): 104-128

Despite having been overlooked in the standard histories of the UK and the European Community, gender politics and gender policies played a significant role in Britain's applications for membership in the EEC in the 1960s. Joining the European Community required that Britain comply with Article 119 on equal pay for equal work. A combination of domestic feminist and labour movement activism, the commitment of unions and parties, and the internationalization of formal commitments to women's rights constituted internal and external pressures for the passage of an Equal Pay Act in 1970. The article argues that the formal legislative commitment to gender pay equality, changing public attitudes towards women's employment, and European membership impacted further domestic social policy reform and slowly began to shift government attitudes towards gender equality.

*29481683*
 29481683

Reflections on 'British Studies in a Broken World', July 2017.

20 Century Br Hist 2018; 29 (1): 156-160

*29481682*
 29481682

Liberal Party Politics, the South African War, and the Rhetoric of Imperial Governance.

20 Century Br Hist 2018; 29 (1): 1-24

This article examines the imperial rhetoric of the Liberal Party during the South African War of 1899-1902, charting its use and development across five key controversies spanning the course of the conflict. Moving beyond traditional interpretations of the Liberal split as the product of competing visions of Empire and approaches to imperialism, this article argues for the need to recognize also the continuities within the imperial rhetoric of fin-de-siecle British Liberalism. Building on recent studies of political languages, it identifies how Liberal speakers from across the party operated within a rhetorical framework that emphasized three ideals of imperial governance: good government, self-government, and pluralism. In doing so, this article seeks to advance our understanding of the South African War as an episode in British party politics, demonstrating the complexity and nuance of the Liberal Party's response to the conflict. Furthermore, by undertaking an in-depth exploration of the rhetoric of imperial governance, this article highlights the Liberal response to the South African War as a case study for the reinvention and reiteration of both party and imperial languages in early twentieth-century Britain, with the potential to offer new insights into the political and imperial cultures of the period.

*29481681*
 29481681

Landlordism, Rent Regulation and the Labour Party in mid-twentieth century Britain, 1950-64.

20 Century Br Hist 2018; 29 (1): 79-103

This article examines the politics of private renting in 1950s and early 1960s Britain, through the radical approach taken by Labour Party towards private landlords. Through setting the radical aims of Labour in a mid-twentieth-century context of decrepit housing, rising rents and sluggish public housing programmes, Labour's rationale in arguing for the 'abolition' of the private landlord is more transparent. This article takes a chronological approach, investigating what actions Labour actors took, at local and national level, and what effect this had on the wider housing market. Part one takes a long view of Labour attitudes to the private rented sector. Part two explores the policy of 'municipalization'-the attempt to place rented homes under local authority control. Part three discusses the post-1962 policy shift to state-sponsored 'improvement' of private rented housing, prior to Labour's victory at the 1964 general election. Three key arguments are made: that Labour's radicalism hastened the collapse of the post-war private rented sector; that rental market weaknesses indicated the confused place of renting in the 'tenurial pattern'; and that the proposed 'abolition' of private landlords had a direct effect on slum clearance and the composition of British cities. The conclusion suggests that Labour's pursuit of the private landlord can shed light on the vast urban transformations of the post-war period. It invites greater attention to be paid to the effects that political ideas had on the composition of the twentieth-century British housing market.

*29481680*
 29481680

'A Tactical Manoeuvre to Apply Pressure': Race and the Role of Public Inquiries in the 1980 Bristol 'Riot'.

20 Century Br Hist 2018; 29 (1): 129-155

When violence erupted on the streets of England in 1981, it undoubtedly shocked the country in its scope and severity. However, such disorder had been foreshadowed when the St Pauls area of Bristol saw anti-police disturbances on 2 April 1980. This article focusses on the responses to this, from the local community and organizations as well as local and national government, which in the historiography has often been relegated to passing mentions prior to detailed discussion of the 1981 events. Utilizing recently released and understudied local records, it argues that appeals for a public inquiry from sections of the local community demonstrates the value awarded to them by this politically marginalized group, and the failings of other democratic forms of registering complaints. Public inquiries have long been a key component of the British constitutional system, allowing a unique public interaction with authorities-but it would take increased violence in Brixton the following year before establishment figures were sufficiently alarmed to grant one. This article argues that obtaining this government-endorsed response and an increased participation in the public discourse should be viewed as an aspect within a broader black civil rights movement, challenging claims that minorities played an underrepresented role in motivating advances. However, there was a clear division of attitudes towards public inquiries, demonstrating the moderate tactics utilized by local organizations and older generations, as opposed to more militant groups and the black youth who took to the streets.

*29481679*
 29481679

Working-Class Ideas and Experiences of Sexuality in Twentieth-Century Britain: Regionalism as a Category of Analysis.

20 Century Br Hist 2018; 29 (1): 58-78

This article will explore region as a category of analysis for understanding gender, sexual cultures, and the expression of same-sex desire. In unpicking the notion of regional difference in both its tangible and intangible forms, it outlines the corresponding impact on how sexual cultures developed and were experienced in twentieth-century Britain. By recognizing that the area in which an individual lived could have as much impact on their sense of self and their sexual experiences as issues of race, gender, and class, a new and fruitful avenue of interpretation is opened up for the history of sexuality and twentieth-century British history more broadly. Such a methodology has the potential to add a new dimension to all histories of non-state-sanctioned sexual experience such as illegitimacy, premarital sex, extramarital affairs, and prostitution. In using regional case studies and interrogating ideas of sexual taboo, this article offers a unique interpretation of sexual experience that destabilizes current London-centric narratives and offers a more democratic and nuanced history of sex.

*29481678*
 29481678

Community Business in Scotland: An Alternative Vision of 'Enterprise Culture', 1979-97.

20 Century Br Hist 2018; ():

The force and coherency with which Margaret Thatcher and her inner circle outlined their vision for 'enterprise culture', like so many aspects of Thatcherism, have masked the complexity of its origins and the histories of alternative responses. This article provides a history of an alternative vision for enterprise culture by examining the community business movement in Scotland, the largest experiment of its kind in the UK in the 1980s and a forerunner of social enterprise. Working across Scotland, but with a hub of activity in the Strathclyde region, practitioners worked with local people to find ways to develop their neighbourhood economy while improving their environment, creating jobs, and developing services needed in their area. This article outlines the origins of the movement, the shared values of its founding members, and how their training in community development informed the community business model. It analyses how practitioners put their ideas into practice and the reasons behind the fragmentation of the movement in the 1990s. It argues that although at face value the concept of community business may appear to chime with the dominant political rhetoric of Thatcher's 'enterprise culture', the history of the movement provides a signpost to an alternative, if unrealised, vision for Scotland's recovery from social and economic depression. Where previous historical research has focused on the political consequences of Thatcher's policies in Scotland, this research connects this discussion to the transformation of Scotland's civic society in the wake of deindustrialization.

*29893937*
 29893937

Exhibition Review Punk's 40th Anniversary-An Itchy Sort of Heritage.

20 Century Br Hist 2018; 29 (2): 309-317

*29800337*
 29800337

'Free and Equal Partners in Your Commonwealth': The Atlantic Charter and Anticolonial Delegations to London, 1941-3.

20 Century Br Hist 2018; 29 (2): 259-283

This article examines the efforts of two anticolonial politicians from the British Empire who used official visits to London and the rhetoric of the Atlantic Charter (14 August 1941) to advance their political careers and self-government for their territories: Burma's U Saw in 1941, and Nigeria's Nnamdi Azikiwe in 1943. Rather than a repetition of the 'Wilsonian moment', these campaigns show how anticolonial forces long active across the Empire took advantage of the opening offered by the Atlantic Charter to make claims on the British government in its wartime weakness. Both U Saw and Azikiwe had been involved in anticolonial politics long before the Charter, but its appearance provided an opportunity to advance their position vis-a-vis political competitors as well as to win concessions from the imperial state. Although the two leaders had different immediate objectives, they both used the prestige of official visits to London and the ambiguous universality of the Charter's language in pursuit of their aims. Their ability to do so attests to the power of anticolonial movements by the early 1940s, and points to alternative paths which the Empire might have followed.

*29800336*
 29800336

'Cinderella of the Education System': Margaret Thatcher's Plan for Nursery Expansion in 1970s Britain.

20 Century Br Hist 2018; 29 (2): 284-308

The Department of Education and Science, led by then Secretary of State Margaret Thatcher, published a White Paper in December 1972 calling for a dramatic expansion of public nursery education, so that it might be available within a decade to all families with 3- and 4-year-old children who chose to utilize it. While this failed policy is seldom remembered today, and Thatcher's efforts to promote the care and education of young children are not considered part of her considerable legacy, the White Paper's policy propositions challenge understandings about the formation and consistency of both Britain's child care policy and 'Thatcherism'. During this period, Thatcher believed that extending the frontiers of the state was appropriate to promote child welfare during the crucial first years of life. She conceived of nursery education as serving a developmental and educational purpose for all children, quite separate from welfare provisions for poor families or work supports for women. It is this crucial, albeit arbitrary, distinction which explains how nursery education was envisaged as an exception to her advocacy of cutting welfare spending.

*29800335*
 29800335

Housing the Citizen-Consumer in Post-war Britain: The Parker Morris Report, Affluence and the Even Briefer Life of Social Democracy.

20 Century Br Hist 2018; 29 (2): 225-258

This article examines debates about the design and provision of post-war housing within the papers and report of the Parker Morris committee. It does so to show how the models of citizens' rights and expectations which underpinned post-war welfare provision were transformed by mass affluence and the dynamic sphere of commercial consumption. Parker Morris's deliberations demonstrate that, as early as the 1950s, the citizen-subject was reimagined as a consuming individual, with requirements based on their expressive needs and consuming desires, and that this had far-reaching consequences for social democratic systems of universal welfare provision. The introduction of consumerist imperatives into publicly defined models of citizens' needs enhanced the political and cultural authority of the commercial domain, prompted a heightened role for commercial experts and market logics within public governance, and served to devalue socialized forms of provision in favour of consumer choice in the private market. The article thus engages with the growing scholarship on the politics of mass consumerism by showing how the material and emotional comforts of post-war affluence came to be constructed as critical to social democratic citizenship and selfhood. Situating this uneasy entanglement of social democratic rights with consumer satisfaction as part of a wider trajectory of political change, the piece suggests that Parker Morris marks an early but significant moment in the transition from post-war welfarism and social democracy to the consumer- and market-oriented forms of governance which came to dominate British politics and society in the latter part of the twentieth century.

*29800334*
 29800334

Dad 'never said much' but... Young Men and Great War Veterans in Day-to-Day-Life in Interwar Britain.

20 Century Br Hist 2018; 29 (2): 199-224

This article explores whether, how, and what young men in interwar Britain heard about the Great War from its veterans. Oral histories are used to enable the first detailed examination of the hitherto largely unexplored topic of the intergenerational transmission of representations of the Great War in interwar Britain. It shows that although many veterans were reticent about their war experiences, young men heard about Great War experiences from veterans more frequently than has previously been acknowledged. What they heard was heterogeneous, like representations in popular culture, but tended to emphasize positive and rewarding elements of wartime service rather than disillusion. While veterans' narratives could be fleeting and ephemeral, this examination of their character shows they should be considered an important component of the wider body of representations of the Great War in interwar popular culture through which young men might 'know' about the Great War. As well as examining what young men heard, consideration is given to alternative ways that young men learned about familial service, and to what triggered veterans' narratives and why some remained silent. Reasons for the trope of the silent veteran are suggested, and its strength in contemporary popular memory is illustrated in discussion of the 'discomposure' it could cause some interviewees.

*29267984*
 29267984

British Widows of the South African War and the Origins of War Widows' Pensions.

20 Century Br Hist 2018; 29 (2): 169-198

The South African War of 1899-1902 cost the lives of 22,000 British and colonial soldiers and created almost 5,000 British war widows. It was in this context that the first state pensions for the widows of rank and file soldiers were introduced in 1901. Triggered by unexpectedly high casualty rates and widespread dissatisfaction with charitable provision, the introduction of state pensions also reflected changing public attitudes towards soldiers and their dependants in the context of an imperial war. Dismissed in the historiography as insignificant because of its low rates and restrictive eligibility clauses, the 1901 scheme in fact delivered pensions to the majority of war widows and made the Edwardian state their most important source of financial support. This article, after discussing the social and political context in which widows' pensions were developed, analyses the economics of the scheme and how key eligibility rules were formulated, before investigating significant changes in the scheme to 1920, the point at which Boer War widows were finally granted full maintenance. Strongly influenced by the practices of Victorian armed forces charities and by contemporary ideologies of gender and class, the South African War pension regulations created precedents which would continue to shape pensions for military widows to the end of the twentieth century.

*29036498*
 29036498

Harold Wilson's 'Lavender List' Scandal and the Shifting Moral Economy of Honour.

20 Century Br Hist 2018; ():

Harold Wilson's resignation honours list of 1976 was almost universally condemned by politicians, civil servants, and the press because it contained a number of high honours to individuals who were seen as scandalously lacking in merit. Unknown officials leaked details to the press and used multiple internal mechanisms, including the Political Honours Scrutiny Committee, to try to block the list, but Wilson pushed it through. This article examines the controversy around the list in terms of how the various parties involved used ideas about scandal, honour, and merit to discredit Wilson, his secretary Marcia Falkender and the honours nominees. It shows that the scandal was shaped by three double standards: one of the main grounds for the disqualification of certain appointees was that they had not donated to Labour; in spite of their traditional prioritization of secrecy around honours, the civil service failed to uphold this tradition when it suited them not to; and critics of the list attacked Falkender's influence over the list even as they defended their own traditional place in determining who was selected for honours. The scandal also shows how the British establishment and British society was struggling to deal with broader questions about the value of exactly the kinds of service that Wilson honoured in the list, namely, capitalist entrepreneurship, popular culture, and contributions from traditional outsiders. While the list was universally condemned in 1976, these forms of service were to become more valued in honours lists from the 1990s.

*30590856*
 30590856

Multiple Deprivation, the Inner City, and the Fracturing of the Welfare State: Glasgow, c. 1968-78.

20 Century Br Hist 2018; 29 (4): 605-624

From 1968, the central government established a series of area-based initiatives that operated on the basis of 'positive discrimination' towards the social needs of local residents. Over the course of the next 10 years, this area-based positive discrimination became an increasingly important part of social policy in Britain. This article uses Glasgow as a case study to show, first, how both the local and the central government attempted to define the problem of 'multiple deprivation' in the 1970s. Second, it shows how social studies were used to locate multiply deprived communities within urban areas, thereby feeding into the identification of the 'inner city' as a policy problem. Finally, this article shows how evidence of the concentration of multiple deprivation and the adoption of area-based strategies contributed to the fracturing of the welfare state, eroding the universalist principles upon which post-war social policy had been based.

*29982817*
 29982817

Aspiration, Agency, and the Production of New Selves in a Scottish New Town, c.1947-c.2016.

20 Century Br Hist 2018; 29 (4): 576-604

Narratives of deindustrialization, urban decline and failing public housing and the negative outcomes associated with these processes dominate accounts of post-war Scotland, bolstering the interpretation of Scottish exceptionalism in a British context. Within these accounts working people appear as victims of powerful and long-term external forces suffering sustained and ongoing deleterious vulnerabilities in terms of employment, health, and housing. This article challenges this picture by focusing on the first Scottish new town which made space for working people's aspiration and new models of the self manifested in new lifestyles and social relations. Drawing on archival data and oral history interviews, we identify how elective relocation fostered and enabled new forms of identity predicated upon new housing, new social relations, and lifestyle opportunities focused on the family and home and elective social networks no longer determined by traditional class and gender expectations. These findings permit an intervention in the historical debates on post-war housing and social change which go beyond the materialistic experience to deeper and affective dimensions of the new town self.

*29860425*
 29860425

'Irish & Roman Catholic Which Upsets All the People Here': Michael McDonnell and British Colonial Justice in Mandatory Palestine, 1927-1936.

20 Century Br Hist 2018; 29 (4): 497-521

In 1927 Michael McDonnell, a diasporic Irish Catholic, was appointed Mandatory Palestine's Chief Justice, being directed to institute firm British-style legal-judicial foundations for future self-governance. This entailed common, equal status for Arab and Jewish Palestinians, implicitly de-privileging the Jewish National Home. McDonnell was resisted in this by the British Mandate's Anglo-Jewish, pro-Zionist Attorney General, Norman Bentwich. McDonnell prevailed but only at the cost of being characterized lastingly as a pro-Arab, Catholic anti-Semite. McDonnell's continuing defence of a supreme, independent judiciary antagonized the Palestine Executive of High Commissioner Arthur Wauchope, who tried to co-opt rather than subordinate Zionist interests. Consequent frictions culminated in 1936 with McDonnell adjudicating against supra-legal British repression of Palestine's great Arab rebellion. For this he was dismissed and ostracized, subsequently publishing critiques of British policy in fringe right-wing organs. Yet McDonnell professed explicitly non-racist views, reflecting a liberal-minded, constitutional Irish nationalist equation of Palestine with Ireland, seeing comparable settler-colonial abuses and native distress as remediable only by transcendentally impartial justice. Britain reneging on these principles led McDonnell, like those Irish imperial servants noted in India, to identify with colonial subjects against colonialism. His case is one of empire as a system of domination being challenged from within, although his removal foreshadowed emerging imperial counter-insurgency's tendency not only to repress subject populations but deny civil-progressive alternatives for managing post-colonial transition.

*29069506*
 29069506

Reconsidering 'Set the People Free': Neoliberalism and Freedom Rhetoric in Churchill's Conservative Party.

20 Century Br Hist 2018; 29 (4): 522-546

It is often assumed that 'Hayekian' or 'neoliberal' influences lay behind Conservative attacks on socialism in 1945 and subsequent calls to 'set the people free' in 1950 and 1951. This assumption has had consequences for our understanding of late-1940s Conservatism and for wider interpretations of post-war politics. Heeding recent calls to reconnect the inter-war and post-war parties and to pay closer attention to how opponents and contexts generate arguments, this article revisits senior Conservatives' rhetoric between 1945 and 1951 to break the link between neoliberal influence and freedom rhetoric. First, it argues that the rhetoric of 1945 was derived from a distinctly Conservative lineage of interwar argument and reflected strategies developed before the publication of F. A. Hayek's 'The Road to Serfdom'. Second, it demonstrates that senior Conservatives' emancipatory rhetoric in opposition after 1945 was neither a simple continuation of these themes nor primarily a response to the public's growing antipathy towards rationing and controls. Rather, such rhetoric was a complex response to Britain's immediate economic difficulties and the political challenges presented by austerity. Finally, the article sheds new light on the strategy that governed the party's campaigns in 1950 and 1951. Churchill and others' calls to 'set the people free' stemmed from a belief that the rhetorical opportunity lay in reconciling liberty with security. In that sense, the leadership had moved beyond begrudging compromises with the 'Attleean settlement' and was instead attempting to define a new identity within the parameters of the welfare state.

*29036716*
 29036716

Justifying British Advertising in War and Austerity, 1939-51.

20 Century Br Hist 2017; 28 (3): 390-413

Drawing together institutional papers, the trade- and national-press, and Mass-Observation documents, this article examines the changing ways that the Advertising Association justified commercial advertising from 1939 to 1951. It argues that the ability to repeatedly re-conceptualize the social and economic purposes of advertising was central to the industry's survival and revival during the years of war and austerity. This matters because the survival and revival of commercial advertising helps to explain the composition of the post-war mixed economy and the emergence of a consumer culture that became the 'golden age' of capitalism. While commercial advertising's role in supporting periods of affluence is well documented, much less is known about its relationship with war and austerity. This omission is problematic. Advertising was only able to shape the 1950s and 1960s economy because its corporate structures remained intact during the 1940s, as the industry withstood the challenges of wartime and the difficulties presented under Attlee's government. Recognizing the deliberate attempts of advertising people to promote a role for commercial advertising invites us to reconsider the inevitability of post-war affluence, while offering fresh insight into the debate around consumer education, freedom of choice, and the centrality of advertising and communication in democratic society: issues central to the society Britain was, and hoped to become.

*28922820*
 28922820

Archive Review: The Black Cultural Archives, Brixton.

20 Century Br Hist 2017; 28 (3): 465-473

*28922819*
 28922819

'If I Ever Have to Go to Prison, I Hope it's a Russian Prison': British Labour, Social Democracy and Soviet Communism, 1919-25.

20 Century Br Hist 2017; 28 (3): 344-366

Through the inter-war period, the USSR became an example of 'socialism in action' that the British labour movement could both look towards and define itself against. British visitors both criticized and acclaimed aspects of the new Soviet state between 1919 and 1925, but a consistently exceptional finding was the Soviet prison. Analysing the visits and reports of British guests to Soviet prisons, the aims of this article are threefold. Using new material from the Russian archives, it demonstrates the development of an intense admiration for, and often a desire to replicate, the Soviet penal system on the part of Labour members, future Communists, and even Liberals who visited Soviet Russia. It also critically examines why, despite such admiration, the effect of Soviet penal ideas failed to significantly influence Labour Party policy in this area. Finally, placing these views within a broader framework of the British labour movement's internal tussles over the competing notions of social democracy and communism, it is argued that a failure to affect policy should not proscribe reappraisals of these notions or the Soviet-Labour Party relationship, both of which were more complex than is currently permitted in the established historiography.

*28922818*
 28922818

Children, Class, and the Search for Security: Writing the Future in 1930s Britain.

20 Century Br Hist 2017; 28 (3): 367-389

This article is based on 269 essays written in 1937 by Middlesbrough schoolboys aged 12-16 years on the topic 'When I leave school', which were collected by the social research organization Mass Observation. The essays provide a counterpoint to social scientific surveys of ordinary people and allow us to work with the boys' own understandings of the world they inhabited. They offer an alternative lens on a period which, at least in relation to the industrial areas of Britain, is often characterized by poverty and unemployment. This representation is largely absent from the children's essays: instead, an overwhelming sense of possibility characterizes their writing, from their wildest fantasies to their most concrete plans. Most dreamt of lives that would be long, fulfilling, domesticated, and happy. This is not to say that they were oblivious to the world around them; indeed an emphasis on security and planning suggested an implicit awareness of material context. Nonetheless these boys expressed a marked determination that their lives would be better than those of their parents. As such, they embodied the educational and occupational aspirations that are more often seen as characteristic of post-war Britain. Their essays illustrate emergent and widely held expectations of social mobility and dreams of cradle-to-grave security in the years before the Second World War, articulated-as they were being lived-by a generation which would go on to elect the 1945 Labour government.

*28922817*
 28922817

'People Love Player's': Cigarette Advertising and the Teenage Consumer in Post-war Britain.

20 Century Br Hist 2017; 28 (3): 414-439

This article explores the background, creation and reception of a prominent cigarette advertising campaign from the early 1960s. The advertisements featured young couples falling in love as they shared Player's Medium cigarettes together. As such, the advertisements reflected the central place of the teenager within post-war British consumer culture. The campaign was built upon the insights of market research, particularly that carried out by Mark Abrams and his research organization Research Services Limited. Historians have played down the significance of Abrams's work, but it is argued here that the studies and reports Abrams produced rendered the teenage consumer knowable in a powerful way. Advertisers and manufacturers now had detailed knowledge about young people's consumption habits and their motivations. Such research helped the British tobacco industry formulate a controversial marketing strategy-the need to 'recruit' young people to the smoking habit-and the People Love Player's campaign was created with this in mind. The representations of love and gender included in the advertisements gave the campaign an emotional pull which was designed to resonate with young people. The advertisements were widely criticized and this drove the British tobacco industry to remove from its advertising appeals which might influence the young, such as love.

*28922816*
 28922816

Duncan Tanner Essay Prize 2016: Historical Pageants, Citizenship, and the Performance of Women's History before Second-Wave Feminism.

20 Century Br Hist 2017; 28 (3): 319-343

This article argues that the early twentieth-century craze for historical pageants provided an opportunity for women's groups to bring a nascent, accessible form of women's history into the lives of local communities across Britain. Mainstream historical pageants were organized across the country, depicting selected episodes from the past usually relating to the local area. However, more than 200 inter-war pageants staged by women's organizations, church groups, and a number of university colleges have not yet been studied. In these pageants, women imaginatively portrayed professional, religious, political, noble, and 'ordinary' women from across history. Prior to second-wave feminism, when scholars advanced the study of women within the academy, thousands of people had been invested in re-enacting women's history since the inter-war years. Emphasizing the bravery and public duties of women in the past, historical pageants provided a non-controversial format through which women's groups could effectively project their beliefs about the role they felt women should play as newly enfranchised citizens. These popular performances capture the dispersed, yet committed, dedication to encouraging women's social citizenship in the inter-war years, and a more pluralistic understanding of women's engagement with 'feminist' ideas in everyday life across Britain.

*28922815*
 28922815

The Consul and the Beatnik: The Establishment, Youth Culture and the Beginnings of the Hippy Trail (1966-8).

20 Century Br Hist 2017; 28 (3): 440-464

This paper analyses the attitudes expressed by consular and embassy officials to a new type of traveller they encountered in the mid-1960s. Their observations are contextualised within wider debates concerning 'youth' in the late 1950s and 1960s. Officials distinguished sharply between 'overlanders' (who could be tolerated or accommodated) and 'beatniks' whose behaviour was characterized as illegal and/or unacceptable. Smoking cannabis was identified as a key marker of beatnik behaviour. Officials' observations are contrasted with four accounts by new travellers from the period. The paper concludes with a proposal for an 'anti-nominian' approach to the study of youth cultures: researchers should be more sensitive to the constructed nature of the labels used to identify the various strands of youth identity.

*28922814*
 28922814

Restoring Victory: Naval Heritage, Identity, and Memory in Interwar Britain.

20 Century Br Hist 2017; 28 (1): 57-82

In the decade following 1918, HMS Victory was restored as a memorial to the nation, empire, the Navy, and all the sailors who had lost their lives in the Great War. This piece of Britain's naval heritage became a focal point for Great War memory and a resource for narrating the Navy's place in post-war Britain. This article analyses the restoration campaign, focusing on its appeal work and the materials it produced, discourses surrounding the restoration and the use of Victory's oak to recover this ship's importance at the intersection between Britain and its Navy in the aftermath of the Great War, and the function that the Navy played in the construction of post-war memory and identity.

*28922799*
 28922799

Kidnapping and a 'Confirmed Sodomite': An Intimate Enemy on the Northwest Frontier of India, 1915-1925.

20 Century Br Hist 2017; 28 (1): 29-56

*28922797*
 28922797

Space, Emotions and the Everyday: The Affective Ecology of 1980s London.

20 Century Br Hist 2017; 28 (1): 110-142

This article explores the relationship between emotions, space and politics in 1980s London, using the Greater London Council, childcare, and racial harassment as particular foci. It brings together political history, the history of emotions, and geography to offer a new way of thinking about political culture, as well as contributing to the history of the 1980s. It is based upon archival sources.

*28922796*
 28922796

A Lady 'in Proper Proportions'? Feminism, Lytton Strachey, and Florence Nightingale's Reputation, 1918-39.

20 Century Br Hist 2017; 28 (1): 1-28

Lytton Strachey's Eminent Victorians has long been regarded as a watershed in attitudes to Victorian culture, widely seen as having instigated a revolutionary backlash against the values and heroes of the Victorian era in England. Its impact, however, on the reputations of his four subjects-Thomas Arnold, General Gordon, Cardinal Manning and Florence Nightingale-has been subjected to surprisingly little scholarly attention. Drawing on the work of gender historians, this article reassesses Strachey's effect on the reputation of Nightingale, using biographies and contemporary reviews of Eminent Victorians. It argues that, far from 'debunking' the famous nurse as is generally assumed, Strachey in many ways enhanced her reputation and rendered her a plausible icon for English feminists of the 1920s and 1930s.

*28922795*
 28922795

The Threshold of the State: Civil Defence, the Blackout and the Home in Second World War Britain.

20 Century Br Hist 2017; 28 (2): 186-208

This article reconsiders the way that the British state extended its control of the home during the Second World War, using the implementation of air raid precautions and the blackout as a lens through which to view the state's developing attitudes to domestic space. Presented here is not the familiar story of pitch-dark, dangerous streets or altered cityscapes of fear and destruction; instead, by examining personal testimony the article inverts traditional treatments of the blackout to look at the interior of dwellings, demonstrating how the realities of total warfare impinged upon the psychological elements that constituted the home. What emerges not only expands historical understandings of the wartime experience of civilians, it also shows civil defence measures as highly visible points on an often antagonistic trajectory of state interactions with citizens concerning the privacy and security of the dwelling in the modern city. The requirements of civil defence, I argue, were not merely the product of exceptional wartime circumstances, but symptomatic of long-standing attempts to open up dwellings to state scrutiny. These attempts had both a significant pre-war lineage and, crucially, implications beyond the end of the war in private homes and on social housing estates.

*28922829*
 28922829

Telling Stories about Post-war Britain: Popular Individualism and the 'Crisis' of the 1970s.

20 Century Br Hist 2017; 28 (2): 268-304

This article argues that, by the 1970s, people in Britain were increasingly insistent about defining and claiming their individual rights, identities and perspectives. Using individual narratives and testimonies, we show that many were expressing desires for greater personal autonomy and self-determination. We suggest that this was an important trend across the post-war decades, and of particular importance to understanding the 1970s. This popular individualism was not the result of Thatcher; if anything, it was a cause of Thatcherism. But this individualism had multiple political and cultural valences; desires for greater individual self-determination, and anger with the 'establishment' for withholding it, did not lead inexorably to Thatcherism. There were, in fact, some sources for, and potential outlets for, popular individualism on the left-outlets that explicitly challenged class, gender and racial inequalities. With this, we suggest the possibility of a new meta-narrative of post-war Britain, cutting across the political narrative that organizes post-war British history into three periods: social democracy, 'crisis' and the triumph of 'neoliberalism'. The 1970s was a key moment in the spread of a popular, aspirational form of individualism in post-war Britain, and this development is critical to our understanding of the history of the post-war years.

*28922828*
 28922828

Erratum.

20 Century Br Hist 2017; 28 (2): 318

*28922827*
 28922827

The Burnley Dog War: The Politics of Dog-Walking and the Battle over Public Parks in Post-Industrial Britain.

20 Century Br Hist 2017; 28 (2): 239-267

This article investigates controversies surrounding dog walking and dog fouling in 1970s and early 1980s Britain, focusing on the microhistory of a series of events in a Lancashire mill town that became known as the 'Burnley Dog War.' A ban on dog walkers from Burnley's main public parks triggered a highly publicised seven-year struggle over access. On one level, the park ban served as a rallying cry for dog lovers across Britain, widening the dividing line between dog owners and dog haters. On another level, it constituted a struggle between antagonists over questions of belonging and exclusion in a town devastated by large-scale deindustrialisation. The dog war stimulated combatants to interrogate the nature and quality of their townscape and their sense of civic identity, the analysis of which allows scrutiny of the impact of deindustrialisation upon their sense of self and place. During the conflict, various aspects of the town's economic history, civic traditions, and landscapes, were alternately disavowed, recovered, rearticulated and contested in relation to its post-industrial present. As it will be shown, the Burnley dispute over dog walking and dog fouling serves as a lens for exploring post-industrial fractiousness along class lines.

*28922826*
 28922826

Catholic Understandings of Female Sexuality in 1960s Britain.

20 Century Br Hist 2017; 28 (2): 209-238

Recent interpretations of religious change in modern Britain have stressed the importance of a sudden and abrupt 'sexual revolution' during the 1960s. The role the Churches played in bringing about their own demise remains a point of debate, particularly in the case of the Catholic Church. This article attempts to move beyond existing historical disputes over a 'religious crisis' and whether it was rooted in 'internal' causes (problems within the Church) or 'external', secular developments. It explores the way sexual knowledge was discussed and disseminated by Catholic authorities during this decade of perceived cultural transition, drawing on the previously unpublished papers of the Papal Commission for Birth Control 1963-5 and the training manuals of the Catholic Marriage Advisory Council (CMAC). These sources offer a unique insight into the often problematic task of reconciling Catholic thought with the discourses of 'sexual liberation'. While the central hierarchy's continued opposition to women's contraceptive autonomy has understandably dominated historical attention, the material presented here suggests that Catholic understandings of female sexuality were not universally at odds with the intellectual infrastructure of a 'sexual revolution'. On the question of female sexual pleasure, progressive Catholic authorities in both the Papal Commission and the CMAC made fervent efforts to engage with contemporary scientific modes of understanding. Perversely, this approach served to neglect certain aspects of corporeal and emotional experience, thereby limiting the case for meaningful doctrinal change.

*28922825*
 28922825

In Quest of the Antique: The Bazaar, Exchange and Mart and the Democratization of Collecting, 1926-42.

20 Century Br Hist 2017; 28 (2): 159-185

The popularization of antique collecting is typically located in the second half of the twentieth century, with the rise of 'retrochic' and the emergence of new markets and online trading websites for anonymously exchanging second-hand goods. Close study of the printed literature connected with the inter-war second-hand trade, however, challenges conventional chronologies in the history of consumer culture, and can provide a new perspective on the role of collecting in British social and cultural life. This article examines the period, after the late 1920s, during which The Bazaar, Exchange and Mart reinvented itself as a forum for antique and decorative art enthusiasts. It argues that, in speaking to and publishing contributions from so-called 'small collectors', this 'Popular Weekly for Collectors and Connoisseurs' helped shape a modern and democratic culture of art appreciation in which ordinary people were actively invited to participate. The private correspondence archive of a Buckinghamshire subscriber who used the Exchange and Mart to sell his collection of 'Egyptian, Greek, and Roman Antiquities' to readers across the country during the 1930s reveals an intimate portrait of the desires, fantasies, and pleasures associated with the popular experience of collecting in pre-war Britain.

*28922824*
 28922824

Tutankhamen, Egyptomania, and Temporal Enchantment in Interwar Britain.

20 Century Br Hist 2017; 28 (4): 516-542

*29186629*
 29186629

The Complex Holiday Calendar of 1902: Responses to the Coronation of Edward VII and the Growth of Edwardian Event Fatigue.

20 Century Br Hist 2017; 28 (4): 489-515

The coronation of Edward VII and events to mark the end of the South African War led to a series of public ceremonies and events in the United Kingdom that had a profound effect on attitudes linked to national occasions and public holidays. This article explores the circumstances surrounding the numerous local and national holidays of 1902. It considers the decision-making process linked to the declaration of a coronation double-bank holiday, which demonstrated the inadequacy of contemporary legislation. The public response to the postponement of the coronation, due to the king's contraction of appendicitis, led to a period of 'event fatigue' in response to further ceremonial events. This showcased how much the British people guarded their right to holiday time and how the coronation had become more synonymous with celebration than with royal ceremony. It also showcased the degree to which the British people had been politicized and were ready to defend what they saw as their rights, in rejection of deference and traditional authority.

*29186628*
 29186628

Rethinking Folk Culture in Twentieth-Century Britain.

20 Century Br Hist 2017; 28 (4): 543-569

Research on folk culture in twentieth-century Britain has focused on elite and transgressive political episodes, but these were not its mainstream manifestations. This article re-evaluates the place of folk culture in twentieth-century Britain in the context of museums. It argues that in the modern heritage landscape folk culture was in an active dialogue with the modern democracy. This story begins with the vexed, and ultimately failed, campaign for a national English folk museum and is traced through the concurrent successes of local, regional, and Celtic 'first wave' folk museums across Britain from the 1920s to the 1960s. The educational activities of these museums are explored as emblematic of a 'conservative modernity', which gave opportunities to women but also restricted their capacity to do intellectual work. By the 1970s, a 'second wave' folk museology is identified, revealing how forms of folk culture successfully accommodated the rapid social change of the later twentieth century, particularly in deindustrializing regions. From this new, museums' perspective, folk culture appears far less marginal to twentieth-century British society. In museums folk culture interacted with mainstream concerns about education, regionalism, and commercialization.

*29186627*
 29186627

Contested Spaces: London and the 1984-5 Miners' Strike.

20 Century Br Hist 2017; 28 (4): 595-617

The 1984-5 British miners' strike can be understood as a defence of place as well as jobs. Such a conception encourages us to foreground the local in accounts of the strike. However, I argue in this article that the local should not be understood in an excessively bounded way. By paying attention to relationships developed between London and the coalfields during the dispute, we can see how direct personal networks of solidarity were constructed between these very different places. This article discusses the spaces in which solidarity activity for miners in London took place. I argue that political activists rooted themselves in localities by constructing permanent spaces such as centres and bookshops, which enabled the development of concrete relationships between different places. I highlight 'twinning' as a distinct spatial tactic used by supporters of the strike to bridge geographical distance and develop personal connections between London and the coalfields. I also show that elements of the state were used to both sustain this solidarity and to restrict the space available for the miners and their supporters. I argue centrally, therefore, that opposing political visions for moving beyond the post-war settlement manifested in a struggle over space in the 1980s.

*29186626*
 29186626

Lesbian Motherhood and the Artificial Insemination by Donor Scandal of 1978.

20 Century Br Hist 2017; 28 (4): 570-594

In January 1978, the London Evening News informed its readers of its shocking discovery that British lesbians were conceiving babies by artificial insemination by donor (AID). Assisted by a respected London gynaecologist, Dr David Sopher, the women were planning and raising children in the context of lesbian relationships, challenging conventional family models and the widespread presumption that lesbianism and motherhood were mutually exclusive identities. The debate which was sparked by the Evening News expose and taken up in Parliament, the national and local media and on the streets in the subsequent weeks, offers an insight into attitudes towards lesbian motherhood in the late 1970s. This article explores constructions of lesbian mothers and the impact on the experiences and identities of lesbian mothers themselves. The late 1970s marked the beginnings of a shift in practices of conception by British lesbians from lesbians who conceived their children in the context of previous heterosexual relationships, to women who utilized AID and other forms of donor insemination to forge new family structures, and this article analyses the stories of some of these women as they emerged from the 1978 debate.

*29186625*
 29186625

'Left out in the Cold: Village Women and Agricultural Labour in England and Wales during the First World War'.

20 Century Br Hist 2016; 27 (1): 1-25

The Women's Land Army (WLA), formed in 1917, has featured prominently in recent academic and popular account of First World War Britain. This interest reflects the attention the WLA drew from politicians, government reporters and contemporary commentators during and immediately after the war itself. Yet, the WLA, which at its peak had 16,000 women working on the land, was just one strand of wartime female agricultural labour, an auxiliary to the thousands of village women who worked throughout the war. Whilst the WLA received numerous plaudits for their participation, village women were 'left out in the cold', as one correspondent to The Times put it, in recognition of their wartime service. This article will place the rural woman worker back to centre stage. It will revisit the often-contradictory wartime estimates of the number of women working in agriculture in England and Wales before moving on to examine how regional farming structures and seasonal demands for labour shaped the use of women workers. It will show that even at the very local level, here utilizing records from the Bedfordshire Women's War Agricultural Committee, demand and supply issues produced a fractured pattern. It will show that concentrating exclusively on the WLA leads to a distorted picture of women's work on the land during the First World War.

*29652116*
 29652116

The Disasters Emergency Committee (DEC) and the Humanitarian Industry in Britain, 1963-85.

20 Century Br Hist 2015; 26 (4): 573-601

This article explores the history of modern British humanitarianism. Specifically, it charts the rise of an extensive humanitarian aid 'industry' in Britain, between 1963 and 1985. It does so through a focus on the Disasters Emergency Committee (DEC), an umbrella body for joint emergency fundraising established in 1963. The DEC is an enduring and important presence in the British humanitarian landscape, as it brings together leading aid agencies to make fundraising campaigns on television after major disasters. This article represents the first systematic historical analysis of the DEC, which it uses to illuminate larger questions about the politics of non-state humanitarianism, state-voluntary sector relations, the political impact of television, and the end of empire. It is shown that while DEC appeals fuelled the growth of its members, this was also a problematic process. Many principal aid agencies wished to shift their focus away from short-term disaster relief work to tackling the long-term structural causes of global poverty instead. It is argued that, despite an increasing political focus, humanitarian organizations were constrained from doing so by the power of television; a perceived lack of public support; the interventions of the British government; and competition between aid agencies in a crowded marketplace. Consequently, continued involvement in short-term, apolitical emergency assistance remained a requirement even for agencies sceptical about its value and impact. This analysis complicates linear narratives of a transition from emergency relief to development aid in post-war British humanitarianism, instead presenting the period as characterized by competing and even contradictory trajectories.

*26775518*
 26775518

Trouble at the National Trust: Post-war Recreation, the Benson Report and the Rebuilding of a Conservation Organization in the 1960s.

20 Century Br Hist 2015; 26 (4): 529-50

The growth of conservation organizations like the National Trust for England, Wales and Northern Ireland (NT), the Royal Society for the Protection of Birds and the county wildlife trusts was one of the more striking features of post-war social change. With their roots in late Victorian and Edwardian ideas of preservation and conservation, the membership of these organizations expanded sharply from the 1960s. The success of these groups, however, also brought its own problems. In particular the practical issues associated with their growth forced them to ask what kind of organizations they were and what kind of organizations they might become. The article focuses on the NT and the soul searching that it undertook in the late 1960s. It draws on but partly seeks to revise recent research on environmental and conservation organizations. In doing so, it documents how the transformation of the NT fits the professionalization thesis proposed within the existing historiographical literature, whilst seeking to draw attention to the influence of broader sociological changes associated with mass affluence and the growth of popular recreation. Given its patrician leadership, the NT was challenged by the democratizing effects of affluence and by the wider climate of cultural modernization. It was this set of cultural and social developments, rather than simply the inevitable logic of professionalization, which provided the conditions in which the Trust was impelled to reinvent itself and modernize its ways of working.

*26775517*
 26775517

Duncan Tanner Essay Prize Winner 2014. Against the 'Sacred Cow': NHS Opposition and the Fellowship for Freedom in Medicine, 1948-72.

20 Century Br Hist 2015; 26 (3): 424-49

This essay recovers organized opposition to the National Health Service (NHS) by considering the Fellowship for Freedom in Medicine (FFM), a conservative organization of doctors who challenged the 'Sacred Cow' of nationalized healthcare in the 1950s and 1960s. While there has been little interest in anti-NHS politics because of shortcomings in the institution's historiography, this study suggests ways a new history of the service can be written. Central to that project is taking the broader ideological and emotive quality of the NHS seriously, and appreciating the way, for all sides of the political spectrum, as well as the general public, the service has always been a contested symbol of post-war British identity. This essay argues that two NHS 'crises'--panics over costs, and disillusionment within general practice--were not merely disagreements over budgets and pay-packets but politically charged moments infused with conservative anxieties over Britain's post-war trajectory. The FFM imagined the NHS as an economically dangerous bureaucratic machine that crushed medical independence and risked pushing the country towards dictatorship. Allies within the Conservative Party, private health insurance industry, and free-market 'think-tanks' worked with the FFM to challenge defences of both the service's operation and meaning. To appreciate why the NHS remains 'the closest thing the English have to a religion', one must consider the apostates as well as the faithful.

*26502665*
 26502665

Healing the Empire: Indian Hospitals in Britain and France during the First World War.

20 Century Br Hist 2015; 26 (3): 347-69

Desperate for soldiers to stem the German onrush in late 1914, the British deployed some 135,000 Indian riflemen--known as sepoys--to the trenches of France and Belgium. Between October 1914 and December 1915, these soldiers fought at the battles of Ypres, Festubert, Givenchy, Neuve Chapelle, Second Ypres, and Loos, suffering some 34,252 casualties. This article looks to the experiences of these men at segregated hospitals in France and England from 1914 to 1915. These hospitals served many of the same dual purposes facilitated by hospitals for English soldiers: namely, they sustained the war-making capacity of the Indian battalions. The Indian hospitals also functioned as sites of propaganda, reaffirming the ideologies and racial hierarchies of imperial rule for audiences at home, abroad, and within the hospital wards. But as this article demonstrates, wounded Indian sepoys were rarely, if ever, mere pawns on the imperial chessboard. Hospital authorities were committed to two policies: returning sepoys to the front and protecting White prestige. Sepoys successfully resisted both. In so doing, Indian hospitals became what British hospital administrators hoped they would not: spaces where imperial subjects contested and even reshaped some of the policies and ideologies of imperial rule.

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Social Security Policy and the Early Disability Movement--Expertise, Disability, and the Government, 1965-77.

20 Century Br Hist 2015; 26 (2): 274-97

In 1965, the Disablement Income Group launched its National Disability Income campaign to fight for equal treatment of disabled people in the British social security system. By 1977, a series of benefits were created to cover the general population. Yet, despite the obvious political significance of these developments, very little research has focused on the early pan-impairment disability non-governmental organization (NGO). Existing scholarship has come from one of two traditions: the 'poverty lobby' and NGO histories that focus on expert campaign groups; and disability studies which describes a teleological narrative of the development of disabled people's attempts to secure civil rights. This article contends that neither approach is satisfactory. The crossovers between these two historical approaches are necessary to understand how these groups operated and to appreciate their political significance. Using the archives of the Disablement Income Group, the Disability Alliance and the Royal Association for Disability and Rehabilitation, this article shows that the history of these NGOs is more nuanced than previously described. Similarly, the novelty and growing power of civil rights and poverty lobby campaigning should not be overstated. Through a specific analysis of the lobby in its social and political context, historians can find a clearer picture of how these groups operated and better analyse their significance.

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Michael Young, the Institute of Community Studies, and the Politics of Kinship.

20 Century Br Hist 2015; 26 (2): 203-24

This article examines the East London-based Institute of Community Studies, and its founder, Michael Young, to show that sociology and social research offered avenues for left-wing political expression in the 1950s. Young, who had previously been Head of the Labour Party Research Department during the Attlee government, drew upon existing currents of psychological and sociological research to emphasize the continuing relevance of the extended family in industrial society and to offer a model of socialist citizenship, solidarity and mutual support not tied to productive work. Young and his colleagues at the Institute of Community Studies promoted the supportive kinship networks of the urban working class, and an idealized conception of the relationships between women, to suggest that family had been overlooked by the left and should be reclaimed as a progressive force. The article shows that the Institute's sociological work was informed by a pre-existing concern with family as a model for cooperative socialism, and suggests that sociology and social research should be seen as important sources of political commentary for scholars of post-war politics.

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'National Hero and Very Queer Fish': Empire, Sexuality and the British Remembrance of General Gordon, 1918-72.

20 Century Br Hist 2015; 26 (2): 175-202

This article presents the first detailed study of General Gordon's remembrance in Britain between 1918 and 1972. Previous scholars have exaggerated the impact of Lytton Strachey's Eminent Victorians (1918). Strachey damaged Gordon's reputation, but part one reveals how several commentators forcefully rebutted Eminent Victorians; official commemorations, books, radio plays, and films celebrated Gordon in the 1930s, as empire featured prominently in mass culture. Didactic uses of his example by the state diminished after 1945, but parts 2 and 3 show how writers used Gordon's story to engage with new debates about Britain's role in the world, immigration and sexuality. The article reveals how a fascination with the sexuality of heroes inspired men as diverse as Viscount Robin Maugham and East End gangster Ronnie Kray to identify with Gordon. Maugham's works and the feature film Khartoum (1966) expressed nostalgia for empire during decolonization, but American screenwriter Robert Ardrey also drew on his experiences in the Congo to present a dark vision of African savagery in Khartoum, a vision performed at Pinewood studios by black immigrants from London's slums. The article questions Edward Berenson's emphasis on the 'charismatic aura' of heroes, emphasizing instead the diversity of engagements inspired through different genre.

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A Change of Heart? British Policies towards Tubercular Refugees during 1959 World Refugee Year.

20 Century Br Hist 2015; 26 (1): 97-121

This article looks at Britain's response to the World Refugee Year (1959-60), and in particular the government's decision to allow entry to refugees with tuberculosis and other chronic illnesses. In doing so, it broke the practice established by the 1920 Aliens' Order which had barred entry to immigrants with a range of medical conditions. This article uses the entry of these sick refugees as an opportunity to explore whether government policy represented as much of a shift in attitude and practice as contemporary accounts suggested. It argues for the importance of setting the reception of tubercular and other 'disabled' refugees in 1959-61 in its very particular historical context, showing it was a case less of the government thinking differently about refugees, and more of how, in a post-Suez context, the government felt obliged to take into account international and public opinion. The work builds on and adds to the growing literature surrounding refugees and disease. It also places the episode within the specificity of the post-war changing epidemiological climate; the creation of the National Health Service; and the welfare state more broadly. In looking at the role of refugee organizations in the Year, the article also contributes to debates over the place of voluntary agencies within British society.

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From Shell Shock to Shellac: The Great War, Blindness, and Britain's Talking Book Library.

20 Century Br Hist 2015; 26 (1): 1-25

Britain's Talking Book Service began as a way of providing reading material to soldiers blinded during the First World War. This account traces the talking book's development from the initial experiments after the War to its debut and reception among blind soldiers and civilians in the 1930s. It has been put together using archives held by the Royal National Institute of Blind People (before its Royal Charter, the NIB) and Blind Veterans UK (formerly St. Dunstan's), the two organizations responsible for Britain's Talking Book Service. The essay's first section reconstructs the search for an alternative way of reading that would benefit people with vision impairments. The next part demonstrates the talking book's impact on the lives of people with disabilities, recovering the voices of blind readers left out of most histories of books, literacy, and reading practices in the twentieth century. The final section reconstructs a debate over the value of recorded books, showing that disputes over their legitimacy are as old as recorded books themselves. In sum, this essay confronts the central issue raised by the convergence of books, media, and disability in the War's aftermath: can a book talk?

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