Hakoum Maram B, Jouni Nahla, Abou-Jaoude Eliane A, Hasbani Divina Justina, Abou-Jaoude Elias A, Lopes Luciane Cruz, Khaldieh Mariam, Hammoud Mira Z, Al-Gibbawi Mounir, Anouti Sirine, Guyatt Gordon, Akl Elie A
Department of Internal Medicine, Clinical Research Institute, American University of Beirut Medical Center, PO Box: 11-0236, Riad-El-Solh, Beirut 1107 2020, Lebanon.
Faculty of Agriculture and Food Sciences, American University of Beirut, PO Box: 11-0236, Riad-El-Solh, Beirut 1107 2020, Lebanon.
J Clin Epidemiol. 2017 Jul;87:78-86. doi: 10.1016/j.jclinepi.2017.04.002. Epub 2017 Apr 12.
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.
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.
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).
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.
利益冲突(COI)在健康研究中的披露和管理日益受到重视。本研究旨在评估发表于临床期刊代表性样本中的随机对照试验作者对财务和非财务利益冲突的报告情况。
我们检索了Ovid Medline,并纳入了2015年发表于119种核心临床期刊之一的200项随机对照试验的随机样本。我们使用一个综合框架对利益冲突进行分类,该框架包括以下内容:个人利益冲突(财务、专业、学术、倡导、个人)和机构利益冲突(财务、专业、学术和倡导)。我们进行了描述性分析和回归分析。
在200项随机对照试验中,188项(94%)报告了作者的利益冲突披露情况,这些披露可在主要文档中获取(92%),也可作为在线获取的国际医学期刊编辑委员会表格获取(12%)。在这188项试验中,57%至少有一位作者报告了至少一项利益冲突;在所有这些试验中,至少有一位作者报告了财务利益冲突。机构利益冲突(11%)和非财务利益冲突(4%)报告较少。很少提及编辑(1%)和医学撰写人员(0%)的利益冲突披露声明。回归分析显示,报告个人财务利益冲突与较高的期刊影响因子之间存在正相关(优势比[OR]=1.06,95%置信区间[CI]=1.02-1.10)、作者数量较多(OR=1.10,95%CI 1.02-1.20)、来自高收入国家机构的隶属关系(OR=)、报告药理学干预的试验(OR=2.28,95%CI 1.13-4.62)。
超过一半已发表的随机对照试验报告至少有一位作者存在利益冲突。试验作者报告财务利益冲突比非财务利益冲突更频繁,报告个人利益冲突比机构利益冲突更频繁。