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10.1002/sim.6865 http://scihub22266oqcxt.onion/10.1002/sim.6865 C5066662!5066662 !26753552     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=26753552 &cmd=llinks): Failed to open stream: HTTP request failed! HTTP/1.1 429 Too Many Requests in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 215 Warning: imagejpeg(C:\Inetpub\vhosts\kidney.de\httpdocs\phplern\26753552 .jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117       Stat+Med 2016 ; 35 (13 ): 2117-32 Nephropedia Template TP {{tp|p=26753552 |t=2016. Evidence, eminence and extrapolation |pdf=|usr=}}{{26753552 }} gab.com Text Evidence, eminence and extrapolation JO: Stat Med http://www.kidney.de/pget.php?&tw=1&pmid=26753552 #FOAvip A full independent drug development programme to demonstrate efficacy may not be ethical and/or feasible in small populations such as paediatric populations or orphan indications. Different levels of extrapolation from a larger population to smaller target populations are widely used for supporting decisions in this situation. There are guidance documents in drug regulation, where a weakening of the statistical rigour for trials in the target population is mentioned to be an option for dealing with this problem. To this end, we propose clinical trials designs, which make use of prior knowledge on efficacy for inference. We formulate a framework based on prior beliefs in order to investigate when the significance level for the test of the primary endpoint in confirmatory trials can be relaxed (and thus the sample size can be reduced) in the target population while controlling a certain posterior belief in effectiveness after rejection of the null hypothesis in the corresponding confirmatory statistical test. We show that point-priors may be used in the argumentation because under certain constraints, they have favourable limiting properties among other types of priors. The crucial quantity to be elicited is the prior belief in the possibility of extrapolation from a larger population to the target population. We try to illustrate an existing decision tree for extrapolation to paediatric populations within our framework. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. Twit Text FOAVip Evidence, eminence and extrapolation ????Stat Med http://www.kidney.de/pget.php?&tw=1&pmid=26753552 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26753552 #FOAvip English Wikipedia <ref>{{Cite pmid|26753552 }}</ref> Evidence, eminence and extrapolation #MMPMID26753552 Hlavin G ; Koenig F ; Male C ; Posch M ; Bauer P Stat Med 2016[Jun]; 35 (13 ): 2117-32 PMID26753552 show ga A full independent drug development programme to demonstrate efficacy may not be ethical and/or feasible in small populations such as paediatric populations or orphan indications. Different levels of extrapolation from a larger population to smaller target populations are widely used for supporting decisions in this situation. There are guidance documents in drug regulation, where a weakening of the statistical rigour for trials in the target population is mentioned to be an option for dealing with this problem. To this end, we propose clinical trials designs, which make use of prior knowledge on efficacy for inference. We formulate a framework based on prior beliefs in order to investigate when the significance level for the test of the primary endpoint in confirmatory trials can be relaxed (and thus the sample size can be reduced) in the target population while controlling a certain posterior belief in effectiveness after rejection of the null hypothesis in the corresponding confirmatory statistical test. We show that point-priors may be used in the argumentation because under certain constraints, they have favourable limiting properties among other types of priors. The crucial quantity to be elicited is the prior belief in the possibility of extrapolation from a larger population to the target population. We try to illustrate an existing decision tree for extrapolation to paediatric populations within our framework. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. |*Statistics as Topic [MESH] |Child [MESH] |Clinical Trials as Topic/*methods [MESH] |Data Interpretation, Statistical [MESH] |Decision Trees [MESH] |Humans [MESH] |Sample Size [MESH]Evidence, eminence and extrapolation (epmc).pdf DeepDyve Pubget Overpricing