Authors of clinical trials reported individual and financial conflicts of interest more frequently than institutional and nonfinancial ones: a methodological survey
Authors of clinical trials reported individual and financial conflicts of interest more frequently than institutional and nonfinancial ones: a methodological survey
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DOI：
10.1016/j.jclinepi.2017.04.002
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发表时间：
2017-07-01
影响因子：
7.2
通讯作者：
Akl, Elie A.
中科院分区：
文献类型：
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作者：
Hakoum, Maram B.;Jouni, Nahla;Akl, Elie A.
背景与目的：在健康研究中，利益冲突（COI）越来越被认为是披露和管理的重要因素。本研究的目的是评估财务和非财务COI的作者发表在一个有代表性的样本临床journals.Methods：我们搜索奥维德Medline，并包括随机样本的200随机对照试验发表在2015年的119个核心临床期刊之一。我们使用一个综合框架对COI进行分类，该框架包括以下内容：个人COI（金融，专业，学术，咨询，个人）和机构COI（金融，专业，学术和咨询）。我们进行了描述性和回归分析。结果：在200项随机对照试验中，188项（94%）报告了作者的COI披露，这些披露可在主文件（92%）和国际医学期刊编辑委员会在线访问的表格（12%）中获得。在188项试验中，57%至少有一名作者报告了至少一项COI;在所有这些试验中，至少有一名作者报告了财务COI。机构COI（11%）和非金融COI（4%）报告较少。编辑（1%）和医学作者（0%）很少提到COI披露声明。回归分析显示，报告个人财务COI和更高的期刊影响因子之间存在正相关（比值比[OR] = 1.06，95%置信区间[CI] = 1.02-1.10），作者人数较多（OR = 1.10，95% CI 1.02-1.20），隶属于高收入国家的机构（OR = 16.75，95% CI 3.38-82.87），以及报告药物干预的试验结论：在已发表的随机对照试验中，半数以上的研究报告至少有一位作者存在COI。试验作者报告财务COI的频率高于非财务COI，个体COI的频率高于机构COI。(C)2017爱思唯尔公司All rights reserved.
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.