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

Céline Buffel du Vaure, Isabelle Boutron, Elodie Perrodeau, Philippe Ravaud, Céline Buffel du Vaure, Isabelle Boutron, Elodie Perrodeau, Philippe Ravaud

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.

Figures

Figure 1
Figure 1
Flow diagram of general practitioner evaluators in the study.

References

    1. Bekelman J, Li Y, Gross C. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289:454–465. doi: 10.1001/jama.289.4.454.
    1. Sismondo S. How pharmaceutical industry funding affects trial outcomes: causal structures and responses. Soc Sci Med. 2008;66:1909–1914. doi: 10.1016/j.socscimed.2008.01.010.
    1. Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2008;5:e217. doi: 10.1371/journal.pmed.0050217. discussion e217.
    1. Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2012;12:MR000033.
    1. Lexchin J, Bero L, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167–1170. doi: 10.1136/bmj.326.7400.1167.
    1. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Ann Intern Med. 2008;149:251–258. doi: 10.7326/0003-4819-149-4-200808190-00006.
    1. Forrow L, Taylor W, Arnold R. Absolutely relative: how research results are summarized can affect treatment decisions. Am J Med. 1992;92:121–124. doi: 10.1016/0002-9343(92)90100-P.
    1. Bucher H, Weinbacher M, Gyr K. Influence of method of reporting study results on decision of physicians to prescribe drugs to lower cholesterol concentration. BMJ. 1994;309:761–764. doi: 10.1136/bmj.309.6957.761.
    1. Kjaergard L, Als-Nielsen B. Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ. 2002;325:249. doi: 10.1136/bmj.325.7358.249.
    1. Tatsioni A, Siontis GC, Ioannidis JP. Partisan perspectives in the medical literature: a study of high frequency editorialists favoring hormone replacement therapy. J Gen Intern Med. 2010;25:914–919. doi: 10.1007/s11606-010-1360-7.
    1. Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am J Psychiatry. 2005;162:1957–1960. doi: 10.1176/appi.ajp.162.10.1957.
    1. Kuehn BM. Harmonizing reporting of financial conflicts. JAMA. 2013;309:19. doi: 10.1001/jama.2012.156627.
    1. Fontanarosa P. Implementation of the ICMJE form for reporting potential conflicts of interest. JAMA. 2010;304:1496. doi: 10.1001/jama.2010.1429.
    1. Drazen J, de Leeuw PW, Laine C, Mulrow C, DeAngelis CD, Frizelle FA, Godlee F, Haug C, Hébert PC, James A, Kotzin S, Marusic A, Reyes H, Rosenberg J, Sahni P, Van der Weyden MB, Zhaori G. Toward more uniform conflict disclosures—the updated ICMJE conflict of interest reporting form. JAMA. 2010;304:212–213. doi: 10.1001/jama.2010.918.
    1. Hopewell S, Clarke M, Moher D, Wager E. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008;5:e20. doi: 10.1371/journal.pmed.0050020.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726–732. doi: 10.7326/0003-4819-152-11-201006010-00232.
    1. Weinfurt KP, Seils DM, Tzeng JP, Lin L, Schulman KA, Califf RM. Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents. PLoS One. 2008;3:e2128. doi: 10.1371/journal.pone.0002128.
    1. Forbes TL. Author disclosure of conflict of interest in vascular surgery journals. J VascSurg. 2011;54:55S–58S.
    1. Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M. Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med. 2009;361:1466–1474. doi: 10.1056/NEJMsa0807160.
    1. Chimonas S, Frosch Z, Rothman DJ. From disclosure to transparency: the use of company payment data. Arch Intern Med. 2011;171:81–86.
    1. Hopewell S, Ravaud P, Baron G, Boutron I. Effect of editors’ implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. BMJ. 2012;344:e4178. doi: 10.1136/bmj.e4178.
    1. Chaudhry S, Schroter S, Smith R, Morris J. Does declaration of competing interests affect readers’ perceptions? A randomised trial. BMJ. 2002;325:1391–1392. doi: 10.1136/bmj.325.7377.1391.
    1. Schroter S, Morris J, Chaudhry S, Smith R, Barratt H. Does the type of competing interest statement affect readers’ perceptions of the credibility of research? Randomised trial. BMJ. 2004;328:742–743. doi: 10.1136/bmj.38035.705185.F6.
    1. Kesselheim AS, Robertson CT, Myers JA, Rose SL, Gillet V, Ross KM, Glynn RJ, Joffe S, Avorn J. A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012;367:1119–1127. doi: 10.1056/NEJMsa1202397.
    1. Silverman GK, Loewenstein GF, Anderson BL, Ubel PA, Zinberg S, Schulkin J. Failure to discount for conflict of interest when evaluating medical literature: a randomised trial of physicians. J Med Ethics. 2010;36:265–270. doi: 10.1136/jme.2009.034496.
    1. Miller RG. Simultaneous Statistical Inference. New York: Springer New York; 1981.
    1. Team RC. R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing; 2012.
    1. Barry HC, Ebell MH, Shaughnessy AF, Slawson DC, Nietzke F. Family physicians’ use of medical abstracts to guide decision making: style or substance? J Am Board FamPract. 1998;14:437–442.
    1. Ebell MH, Barry HC, Slawson DC, Shaughnessy AF. Finding POEMs in the medical literature. J FamPract. 1999;48:350–355.
    1. The impact of open access upon public health. PLoS Med. 2006;3:e252.
    1. Thompson D. Understanding financial conflicts of interest. N Engl J Med. 1993;329:573–576. doi: 10.1056/NEJM199308193290812.
    1. Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA. 2012;307:669–670. doi: 10.1001/jama.2012.154.
    1. Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P. Reporting of sample size calculation in randomised controlled trials: review. BMJ. 2009;338:b1732. doi: 10.1136/bmj.b1732.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner