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.

Abstract : 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 = 0.84) for abstracts reporting the funding source only versus no funding source or CoI; -0.4 (-1.3; 0.4) (P = 0.39) for abstracts reporting the funding source and CoI versus no funding source and CoI; and -0.6 (-1.5; 0.2) (P = 0.15) 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.
Type de document :
Article dans une revue
BMC Medicine, BioMed Central, 2014, 12 (1), pp.69. 〈10.1186/1741-7015-12-69〉
Liste complète des métadonnées

Littérature citée [31 références]  Voir  Masquer  Télécharger

http://www.hal.inserm.fr/inserm-00988295
Contributeur : Ed. Bmc <>
Soumis le : mercredi 7 mai 2014 - 17:15:48
Dernière modification le : lundi 11 décembre 2017 - 15:16:01
Document(s) archivé(s) le : jeudi 7 août 2014 - 11:55:34

Identifiants

Collections

Citation

Céline Du Vaure, Isabelle Boutron, Elodie Perrodeau, Philippe Ravaud. 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.. BMC Medicine, BioMed Central, 2014, 12 (1), pp.69. 〈10.1186/1741-7015-12-69〉. 〈inserm-00988295〉

Partager

Métriques

Consultations de la notice

1803

Téléchargements de fichiers

280