Broager Mihaela Ivosevic, Faltinsen Erlend, Hróbjartsson Asbjørn, Lundh Andreas, Nejstgaard Camilla Hansen
Cochrane Denmark and Centre for Evidence-Based Medicine Odense (CEBMO), Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Open Patient data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark.
Cochrane Denmark and Centre for Evidence-Based Medicine Odense (CEBMO), Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Open Patient data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark; Department of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark.
J Clin Epidemiol. 2025 Jun;182:111786. doi: 10.1016/j.jclinepi.2025.111786. Epub 2025 Apr 11.
To assess the adequacy of reporting of funder and authors' financial conflicts of interest information in randomized trial publications of drugs or devices, and to assess to which degree the missing information can be obtained from other sources.
We took a random sample of 200 randomized trial publications indexed in MEDLINE in May 2022. Two authors independently assessed the adequacy of funder and authors' conflicts of interest information. We considered funder information adequate when name of funder(s), type(s) of support, and funder's involvement were reported. Similarly, we considered authors' financial conflicts of interest information adequate when name of organization(s), type of relationship(s), and the involvement of author(s) with financial conflicts of interest were reported. We attempted to obtain missing information through multiple approaches (eg, searching websites, trial registries, and public disclosure databases) and recorded the time taken.
We found that information on funder was adequately reported in 67 (34%) trial publications, partly adequate in 110 (55%), inadequate in 12 (6%), and 11 (6%) had no information available. Often, trial publications did not report the type(s) of support (40%) and the funders' involvement in the trial design, conduct, analysis, and reporting (58%). After obtaining missing information, the proportion of trial publications with adequate funder information increased by 32% (we obtained information on all domains for 64 of 133 trial publications) by spending a median time of 13 minutes per trial. Information on authors' financial conflicts of interest was adequately reported in 180 (90%) trial publications, and we obtained the missing information for four trials (20%) by spending a median time of 28 minutes per trial.
In contemporary trial publications, funder information was rarely adequately reported, whereas authors' financial conflicts of interest information was adequately reported in almost all trial publications. Our approaches for obtaining missing information improved the adequacy of funder and conflicts of interest information. Our approaches were particularly effective in obtaining funder information, whereas efforts to obtain conflicts of interest information were less successful and more time-consuming. Our findings provide context for systematic review authors when deciding if and how to search for missing funder and conflicts of interest information while balancing the need for obtaining information with the time spent searching.
评估药物或器械随机试验出版物中资助者和作者财务利益冲突信息的报告充分性，并评估从其他来源获取缺失信息的程度。
我们从2022年5月MEDLINE索引的200篇随机试验出版物中随机抽样。两位作者独立评估资助者和作者利益冲突信息的充分性。当报告了资助者名称、支持类型和资助者参与情况时，我们认为资助者信息充分。同样，当报告了组织名称、关系类型以及有财务利益冲突的作者的参与情况时，我们认为作者财务利益冲突信息充分。我们试图通过多种途径（如搜索网站、试验注册库和公开披露数据库）获取缺失信息，并记录所花费的时间。
我们发现，67篇（34%）试验出版物中资助者信息报告充分，110篇（55%）部分充分，12篇（6%）不充分，11篇（6%）没有可用信息。试验出版物常常未报告支持类型（40%）以及资助者在试验设计、实施、分析和报告中的参与情况（58%）。获取缺失信息后，有充分资助者信息的试验出版物比例增加了32%（在133篇试验出版物中，我们为64篇获取了所有领域的信息），每项试验平均花费13分钟。180篇（90%）试验出版物中作者财务利益冲突信息报告充分，我们通过每项试验平均花费28分钟为四项试验（20%）获取了缺失信息。
在当代试验出版物中，资助者信息很少得到充分报告，而作者财务利益冲突信息在几乎所有试验出版物中都得到了充分报告。我们获取缺失信息的方法提高了资助者和利益冲突信息的充分性。我们的方法在获取资助者信息方面特别有效，而获取利益冲突信息的努力不太成功且更耗时。我们的研究结果为系统评价作者在决定是否以及如何搜索缺失的资助者和利益冲突信息时提供了背景，同时平衡了获取信息的需求与搜索所花费的时间。
