Association of author's financial conflict of interest with characteristics and outcome of rheumatoid arthritis randomized controlled trials
Association of author's financial conflict of interest with characteristics and outcome of rheumatoid arthritis randomized controlled trials
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DOI：
10.1093/rheumatology/key368
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发表时间：
2019-05-01
期刊：
影响因子：
5.5
通讯作者：
Torralba, Karina D.
中科院分区：
文献类型：
--
作者：
Khan, Nasim Ahmed;Nguyen, Chau L.;Torralba, Karina D.
目标。旨在检查 RA 药物治疗随机对照试验 (RCT) 作者中报告的财务利益冲突 (FCOIs) 的患病率、类型和时间趋势及其与研究结果的关联。方法。我们确定了 2002 年 3 月、2006 年 7 月和 2010 年 11 月发表的原始非 1 期平行组药物治疗 RA 随机对照试验。两名研究人员独立获得了试验特征数据。作者的 FCOI 分为酬金/咨询费收据、雇员身份、研究补助金和股权。进行多变量逻辑回归以确定 FCOIs 是否与研究结果独立相关。结果。总共确定了 146 项符合条件的 RCT。其中，83 项 (58.4%) 随机对照试验至少有一名作者具有 FCOI [雇员身份：63 项 (43.2%)，酬金/咨询费收据：49 项 (33.6%)，研究补助金：30 项 (20.5%)，股权：28 项 (19.2%)]。酬金/咨询费收据、研究补助金和股票所有权的报告数量显着增加。任何 FCOI 本身的报告与积极结果无关[有作者 FCOI 的 50/73 (68.5%) vs 无作者 FCOI 的 36/52 (69.2%)，P=0.93]。然而，酬金/咨询费的收取与积极结果的可能性增加独立相关[调整后的比值比 (95% CI) 为 3.24 (1.06 - 9.88)]。一般来说，使用 FCOIs 的试验明显更有可能是多中心的、入组人数较多、使用生物制剂或小分子作为实验干预，并且对一些方法学质量指标有更好的报告。结论。 RA 药物 RCT 作者中的 FCOI 报告很常见，并且暂时增加。酬金/咨询费的收取与积极的研究结果独立相关。
Objectives. To examine the prevalence, types and temporal trends of reported financial conflicts of interest (FCOIs) among authors of drug therapy randomized controlled trials (RCTs) for RA and their association with study outcomes.Methods. We identified original, non - phase 1, parallel-group, drug therapy RA RCTs published in the years 2002 - 03, 2006 - 07, and 2010 - 11. Two investigators independently obtained trial characteristics data. Authors' FCOIs were classified as honoraria/consultation fees receipt, employee status, research grant, and stock ownership. Multivariable logistic regression was performed to identify whether FCOIs were independently associated with study outcome.Results. A total of 146 eligible RCTs were identified. Of these, 83 (58.4%) RCTs had at least one author with an FCOI [employee status: 63 (43.2%), honoraria/consultation fees receipt: 49 (33.6%), research grant: 30 (20.5%), and stock ownership: 28 (19.2%)]. A remarkable temporal increase in reporting of honoraria/consultation fees receipt, research grant, and stock ownership was seen. The reporting of any FCOI itself was not associated with positive outcome [50/73 (68.5%) with author FCOI vs 36/52 (69.2%) without author FCOI, P=0.93]. However, honoraria/consulting fees receipt was independently associated with increased likelihood of a positive outcome [adjusted odds ratio (95% CI) of 3.24 (1.06 - 9.88)]. In general, trials with FCOIs were significantly more likely to be multicentre, have larger enrolment, use biologic or a small molecule as the experimental intervention, and have better reporting of some methodological quality measures.Conclusion. FCOI reporting in RA drug RCT authors is common and temporally increasing. Receipt of honoraria/consulting fees was independently associated with a positive study outcome.