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Prevention of selective outcome reporting: let us start from the beginning

European Journal of Clinical Pharmacology : Volume 72, Issue 9, September 2016

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Prevention of selective outcome reporting: let us start from the beginning

Content Provider	Springer Nature Link
Author	Dal Ré, Rafael Marušić, Ana
Copyright Year	2016
Abstract	Healthcare professionals and patients could be negatively influenced in their judgments by articles and meta-analyses presenting selective outcome reporting. Clinical trials should be transparent from inception to the publication of results. To this end, trial prospective registration is an ethical and scientific requirement that have shown to be effective in preventing selective reporting of outcomes. However, even journals with a clear pre-registration policy publish trial results that were retrospectively registered.Analyses of registration of randomized clinical trials recently published in top specialty journals and of meta-analyses with suspicion of including trials with outcome reporting bias have shown that retrospective registration is in the range from 56 to 76 %. This translates into publication of primary endpoints that differ from those included in the registry: some 30 % of trials showed discrepancies between the primary endpoint in the trial registry and the article. Furthermore, it has been shown that 8 % of all clinical trials published by 6 high-impact ICMJE-member journals was retrospectively registered after primary endpoint ascertainment could have had taken place, raising concerns that endpoints may not have been pre-specified, or were changed. With regards to meta-analyses, 34 % of Cochrane systematic reviews included one or more trials with a high suspicion of selective reporting bias for the primary outcome.Retrospective registration of trials may foster selective outcome reporting unless journal editors implement specific quality control processes aiming to prevent or minimize this type of bias. Prospective registration of trials—and protocol public disclosure if proven effective in future studies—prevents outcome reporting bias, a must to ensure clinicians and patients have access to reliable clinical trial results. Journal editors should enforce, rather than encourage, appropriate measures to ensure publication of trials free of outcome reporting bias.
Starting Page	1283
Ending Page	1288
Page Count	6
File Format	PDF
ISSN	00316970
Journal	European Journal of Clinical Pharmacology
Volume Number	72
Issue Number	10
e-ISSN	14321041
Language	English
Publisher	Springer Berlin Heidelberg
Publisher Date	2016-08-02
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Clinical trials Registration Retrospective registration Clinicaltrials.gov. Outcome reporting bias Reporting bias Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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