P1-541 Reporting of eligibility criteria of randomised trials: empirical study comparing trial protocols to subsequent articles

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Reporting of eligibility criteria of randomised trials: cohort study comparing trial protocols with subsequent articles

OBJECTIVE To determine whether and how eligibility criteria of participants prespecified in protocols of randomised trials are reported in subsequent articles. DESIGN Cohort study. SETTING Protocols submitted to the ethics committee of a German medical faculty. DATA SOURCES 52 trial protocols and 78 subsequent publications published between 2000 and 2006. MAIN OUTCOME MEASURE Proportion...

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Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.

CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected, but direct evidence of such bias is currently limited to case reports. OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of randomized trials. DESIGN Cohort study using protocols and published reports of random...

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Patterns of Clinical Trial Eligibility Criteria

Medical research would benefit from automatic methods that support eligibility evaluation for patient enrollment in clinical trials and design of eligibility criteria. In this study we addressed the problem of formalizing eligibility criteria. By analyzing a large set of breast cancer clinical trials we derived a set of patterns, that capture typical structure of conditions, pertaining to synta...

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ژورنال

عنوان ژورنال: Journal of Epidemiology & Community Health

سال: 2011

ISSN: 0143-005X

DOI: 10.1136/jech.2011.142976h.28