Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners-confidence in conclusions, a three-arm randomized controlled trial

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• 作者：Céline Buffel du Vaure ; Isabelle Boutron ; Elodie Perrodeau ; Philippe Ravaud
• 关键词：Funding ; Conflict of interest ; General Practitioner ; Abstract ; Reporting
• 刊名：BMC Medicine
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：12
• 期：1
• 全文大小：212 KB
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• 刊物主题：Medicine/Public Health, general; Biomedicine general;
• 出版者：BioMed Central
• ISSN：1741-7015

文摘

Background Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts. However, no specific recommendation is related to the reporting of conflicts of interest (CoI). The objective was to compare physicians-confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubMed. Methods We planned a three-arm parallel-group randomized trial. French general practitioners (GPs) were invited to participate and were blinded to the study’s aim. We used a representative sample of 75 abstracts of pharmaceutical industry-funded randomized controlled trials published in 2010 and indexed in PubMed. Each abstract was standardized and reported in three formats: 1) no mention of the funding source or CoI; 2) reporting the funding source only; and 3) reporting the funding source and CoI. GPs were randomized according to a computerized randomization on a secure Internet system at a 1:1:1 ratio to assess one abstract among the three formats. The primary outcome was GPs-confidence in the abstract conclusions (0, not at all, to 10, completely confident). The study was planned to detect a large difference with an effect size of 0.5. Results Between October 2012 and June 2013, among 605 GPs contacted, 354 were randomized, 118 for each type of abstract. The mean difference (95% confidence interval) in GPs-confidence in abstract findings was 0.2 (-0.6; 1.0) (P--.84) for abstracts reporting the funding source only versus no funding source or CoI; -0.4 (-1.3; 0.4) (P--.39) for abstracts reporting the funding source and CoI versus no funding source and CoI; and -0.6 (-1.5; 0.2) (P--.15) for abstracts reporting the funding source and CoI versus the funding source only. Conclusions We found no evidence of a large impact of trial report abstracts mentioning funding sources or CoI on GPs-confidence in the conclusions of the abstracts. Trial Registration ClinicalTrials.gov identifier: NCT01679873