Authors of clinical trials reported individual and financial conflicts of interest more frequently than institutional and nonfinancial ones: a methodological survey

被引:22
作者
Hakoum, Maram B. [1 ]
Jouni, Nahla [2 ]
Abou-Jaoude, Eliane A. [3 ]
Hasbani, Divina Justina [4 ]
Abou-Jaoude, Elias A. [5 ]
Lopes, Luciane Cruz [6 ]
Khaldieh, Mariam [7 ]
Hammoud, Mira Z. [8 ]
Al-Gibbawi, Mounir [4 ]
Anouti, Sirine [9 ]
Guyatt, Gordon [10 ]
Akl, Elie A. [1 ,10 ,11 ]
机构
[1] Amer Univ Beirut, Med Ctr, Clin Res Inst, Dept Internal Med, POB 11-0236, Beirut 11072020, Lebanon
[2] Amer Univ Beirut, Fac Agr & Food Sci, POB 11-0236, Beirut 11072020, Lebanon
[3] SUNY Buffalo, Dept Internal Med, 12 Capen Hall, Buffalo, NY 14260 USA
[4] Amer Univ Beirut, Fac Med, POB 11-0236, Beirut 11072020, Lebanon
[5] SUNY Buffalo, Dept Biomed Sci, 12 Capen Hall, Buffalo, NY 14260 USA
[6] Univ Sorocaba, Grad Program Pharmaceut Sci, Rod Raposo Tavares,Km 92-5, BR-18023000 Sao Paulo, Brazil
[7] Amer Univ Beirut, Fac Sci, POB 11-0236, Beirut 11072020, Lebanon
[8] Massachusetts Gen Hosp, Dept Psychiat, 55 Fruit St, Boston, MA 02144 USA
[9] Amer Univ Beirut, Dept Epidemiol & Populat Hlth, POB 11-0236, Beirut 11072020, Lebanon
[10] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1200 Main St W, Hamilton, ON L8N 3Z5, Canada
[11] Amer Univ Beirut, Med Ctr, Dept Internal Med, POB 11-0236, Beirut 11072020, Lebanon
关键词
Conflict of interest; Randomized controlled trial; Bias; ICMJE; Trial author; Reporting; RANDOMIZED CONTROLLED-TRIALS; FUNDING SOURCES; DISCLOSURE; GUIDELINES; ASSOCIATION; SPONSORSHIP; EDITORIALS; IMPACT; POLICY; BIAS;
D O I
10.1016/j.jclinepi.2017.04.002
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Background and Objective: Conflicts of interest (COIs) are increasingly recognized as important to disclose and manage in health research. The objective of this study was to assess the reporting of both financial and nonfinancial COI by authors of randomized controlled trials published in a representative sample of clinical journals. Methods: We searched Ovid Medline and included a random sample of 200 randomized controlled trials published in 2015 in one of the 119 Core Clinical Journals. We classified COI using a comprehensive framework that includes the following: individual COIs (financial, professional, scholarly, advocatory, personal) and institutional COIs (financial, professional, scholarly, and advocatory). We conducted descriptive and regression analyses. Results: Of the 200 randomized controlled, trials, 188 (94%) reported authors' COI disclosures that were available in the main document (92%) and as International Committee of Medical Journal Editors forms accessible online (12%). Of the 188 trials, 57% had at least one author reporting at least one COI; in all these trials, at least one author reported financial COI. Institutional COIs (11%) and nonfinancial COIs (4%) were less commonly reported. References to COI disclosure statements for editors (1%) and medical writers (0%) were seldom present. Regression analyses showed positive associations between reporting individual financial COI and higher journal impact factor (odds ratio [OR] = 1.06, 95% confidence interval [CI] = 1.02-1.10), larger number of authors (OR = 1.10, 95% CI 1.02-1.20), affiliation with an institution from a high-income country (OR = 16.75, 95% CI 3.38-82.87), and trials reporting on pharmacological interventions (OR = 2.28, 95% CI 1.13-4.62). Conclusion: More than half of published randomized controlled trials report that at least one author has a COI. Trial authors report financial COIs more often than nonfinancial COIs and individual COIs more frequently than institutional COIs. (C) 2017 Elsevier Inc. All rights reserved.
引用
收藏
页码:78 / 86
页数:9
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