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2020 ; 6
(10
): 1147-1152
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Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID)
#MMPMID32292626
Jin X
; Pang B
; Zhang J
; Liu Q
; Yang Z
; Feng J
; Liu X
; Zhang L
; Wang B
; Huang Y
; Josephine Fauci A
; Ma Y
; Soo Lee M
; Yuan W
; Xie Y
; Tang J
; Gao R
; Du L
; Zhang S
; Qi H
; Sun Y
; Zheng W
; Yang F
; Chua H
; Wang K
; Ou Y
; Huang M
; Zhu Y
; Yu J
; Tian J
; Zhao M
; Hu J
; Yao C
; Li Y
; Zhang B
Engineering (Beijing)
2020[Oct]; 6
(10
): 1147-1152
PMID32292626
show ga
Since its outbreak in December 2019, a series of clinical trials on coronavirus
disease 2019 (COVID-19) have been registered or carried out. However, the
significant heterogeneity and less critical outcomes of such trials may be
leading to a waste of research resources. This study aimed to develop a core
outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome
issues. The study was conducted according to the Core Outcome Measures in
Effectiveness Trials (COMET) Handbook: Version 1.0, a guideline for COS
development. A research group was set up that included experts in respiratory and
critical medicine, traditional Chinese medicine (TCM), evidence-based medicine,
clinical pharmacology, and statistics, in addition to medical journal editors.
Clinical trial registry websites (www.chictr.org.cn and clinicaltrials.gov) were
searched to retrieve clinical trial protocols and outcomes in order to form an
outcome pool. A total of 78 clinical trial protocols on COVID-19 were included
and 259 outcomes were collected. After standardization, 132 outcomes were
identified within seven different categories, of which 58 were selected to
develop a preliminary outcome list for further consensus. After two rounds of
Delphi survey and one consensus meeting, the most important outcomes for the
different clinical classifications of COVID-19 were identified and determined to
constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID
includes one outcome for the mild type (time to 2019 novel coronavirus
(2019-nCoV) reverse transcription-polymerase chain reaction (RT-PCR) negativity),
four outcomes for the ordinary type (length of hospital stay, composite events,
score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five
outcomes for the severe type (composite events, length of hospital stay, arterial
oxygen partial pressure (PaO(2))/fraction of inspired oxygen (FiO(2)), duration
of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome
for critical type (all-cause mortality), and one outcome for rehabilitation
period (pulmonary function). The COS-COVID is currently the most valuable and
practical clinical outcome set for the evaluation of intervention effect, and is
useful for evidence assessment and decision-making. With a deepening
understanding of COVID-19 and application feedback, the COS-COVID should be
continuously updated.
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