Authors' Self-Declared Financial Conflicts of Interest Do Not Impact the Results of Major Cardiovascular Trials

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:61

Article

Aneja, Ashish¹  Esquitin, Ricardo²  Shah, Kshitij³  Iyengar, Rupa⁴  Nisenbaum, Rosane^5,6,7  Melo, Magda⁷  Matthewkutty, Shiny⁴  Sethi, Sanjum S.⁴  Mamdani, Muhammad⁷  Farkouh, Michael E.^4,7,8 

[1] Case Western Reserve Univ, Heart & Vasc Ctr, Cleveland, OH 44106 USA

[2] Harvard Univ, Beth Israel Deaconess Med Ctr, Sch Med, Div Cardiol, Boston, MA 02215 USA

[3] James J Peters VA Med Ctr, Dept Med, Bronx, NY USA

[4] Mt Sinai Sch Med, Zena & Michael A Weiner Cardiovasc Inst, New York, NY 10029 USA

[5] Univ Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Ctr Res Inner City Hlth,Keenan Res Ctr, Toronto, ON M5B 1W8, Canada

[6] Univ Toronto, Dalla Lana Sch Publ Hlth, Toronto, ON, Canada

[7] Univ Toronto, Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr, Toronto, ON, Canada

[8] Univ Toronto, Peter Munk Cardiac Ctr, Toronto, ON, Canada

关键词: cardiovascular;    clinical trial;    conflicts of interest;    financial;    industry;    randomized controlled trials;   

DOI  :  10.1016/j.jacc.2012.10.056

来源: Elsevier

【 摘 要 】

Objectives This study assessed whether the results of major, potentially practice-altering cardiovascular trials were influenced by the authors' self-declared financial conflicts of interest (FCOI). Secondary objectives included assessment of trial outcomes by source of funding, by FCOI subtype, and by trial endpoints. Background Financial conflicts of interest, ubiquitous in cardiovascular medicine because of significant investigator-industry collaborations, potentially can influence trial outcomes. Methods A MEDLINE search was performed using the MeSH term cardiovascular disease limited to randomized controlled trials and clinical trials published from January 1, 2000, through April 15, 2008, in 3 high-impact journals. Two reviewers independently abstracted data from the published article. Chi-square tests, Fisher exact tests, and multivariate logistic regression were used to assess the associations between FCOI and study characteristics and between FCOI and trial outcomes. Results Of the 550 articles reviewed, 51.1% satisfied FCOI criteria, including at least one of the following: stock ownership, employee, speaker's bureau, and consultant). Of the 538 articles providing sponsorship information, 34.6% reported funding solely by nonprofit organizations, 48.3% reported funding solely by industry, and 17.1% reported funding by a combination. Prevalence of FCOI significantly increased with level of industry funding: 21.5% (none), 50.0% (shared), 75.0% (industry solely, n = 281, p < 0.0001). However, no differences in reporting of favorable results were detected when articles were analyzed by self-declared FCOI (60.5% vs. 59.5% in those with and without, odds ratio: 1.04, p = 0.81). This result was upheld in multivariate analysis. Conclusions Authors' self-declared FCOI and source of funding do not seem to impact outcomes in major cardiovascular clinical trials. (J Am Coll Cardiol 2013;61:1137-43) (C) 2013 by the American College of Cardiology Foundation

【 授权许可】

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