Reporting of eligibility criteria of randomised trials: cohort study comparing trial protocols with subsequent articles
BMJPublished 5 April 2011Open access
Anette Blümle, Joerg J Meerpohl, Gerta Rücker, Gerd Antes, Martin Schumacher, Erik von Elm
Citations43
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TL;DR
To determine whether and how eligibility criteria of participants prespecified in protocols of randomised trials are reported in subsequent articles, 52 trial protocols and 78 subsequent publications published between 2000 and 2006 were studied.
Abstract
Many users of trial information rely on published journal articles. These articles generally do not reflect the exact definition of the study population as prespecified in the protocol. Incomplete or inadequate reporting of eligibility criteria hampers a proper assessment of the applicability of trial results.
Keywords
Decision SciencesMedicineEconomics, Econometrics and Finance
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