随机临床试验中的商业资助和估计干预效果:meta流行病学研究的系统回顾

IF 5 2区 生物学 Q1 MATHEMATICAL & COMPUTATIONAL BIOLOGY Research Synthesis Methods Pub Date : 2022-11-10 DOI:10.1002/jrsm.1611
Camilla Hansen Nejstgaard, David Ruben Teindl Laursen, Andreas Lundh, Asbj?rn Hróbjartsson
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引用次数: 1

摘要

我们调查了在随机试验中商业资助与估计干预效果的关联程度。我们纳入了meta-流行病学研究,并发表了关于商业资助与随机试验结果或结论之间关系的数据。我们搜索了五个数据库和其他来源。我们为每项荟萃流行病学研究选择一个结果,最好是未调整的优势比(ROR),例如优势比(商业资助)/优势比(非商业资助)。我们汇总了随机效应荟萃分析中的ROR (ROR <1表明在商业资助的试验中夸大了干预效应),并根据研究目的进行了分组(预先计划):商业资助本身与商业资助影响的风险。我们纳入8项荟萃流行病学研究(264项荟萃分析,2725项试验)。总ROR为0.95(95%可信区间0.85-1.06)。亚组分析显示,商业资助本身研究的ROR为1.06(0.95-1.17),商业资助影响风险研究的ROR为0.88(0.79-0.97),两者之间存在差异(p = 0.02)。综上所述,当将商业资助本身的研究与商业资助影响风险的研究结合起来时,我们发现商业资助与估计的干预效果之间没有统计学上显著的关联。预先计划的亚组分析表明,具有高风险商业资助者影响的试验将干预效果平均夸大了12%(21%-3%)。我们的结果不同于以前的理论考虑和方法研究的结果,因此需要确认。我们建议谨慎地解释商业资助试验的结果,特别是当资助者对试验设计、实施、分析或报告有直接影响的风险时。
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Commercial funding and estimated intervention effects in randomized clinical trials: Systematic review of meta-epidemiological studies

We investigated to which degree commercial funding is associated with estimated intervention effects in randomized trials. We included meta-epidemiological studies with published data on the association between commercial funding and results or conclusions of randomized trials. We searched five databases and other sources. We selected one result per meta-epidemiological study, preferably unadjusted ratio of odds ratios (ROR), for example, odds ratio(commercial funding)/odds ratio(noncommercial funding). We pooled RORs in random-effects meta-analyses (ROR <1 indicated exaggerated intervention effects in commercially funded trials), subgrouped (preplanned) by study aim: commercial funding per se versus risk of commercial funder influence. We included eight meta-epidemiological studies (264 meta-analyses, 2725 trials). The summary ROR was 0.95 (95% confidence interval 0.85–1.06). Subgroup analysis revealed a difference (p = 0.02) between studies of commercial funding per se, ROR 1.06 (0.95–1.17) and studies of risk of commercial funder influence, ROR 0.88 (0.79–0.97). In conclusion, we found no statistically significant association between commercial funding and estimated intervention effects when combining studies of commercial funding per se and studies of risk of commercial funder influence. A preplanned subgroup analysis indicated that trials with high risk of commercial funder influence exaggerated intervention effects by 12% (21%–3%), on average. Our results differ from previous theoretical considerations and findings from methodological studies and therefore call for confirmation. We suggest it is prudent to interpret results from commercially funded trials with caution, especially when there is a risk that the funder had direct influence on trial design, conduct, analysis, or reporting.

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来源期刊
Research Synthesis Methods
Research Synthesis Methods MATHEMATICAL & COMPUTATIONAL BIOLOGYMULTID-MULTIDISCIPLINARY SCIENCES
CiteScore
16.90
自引率
3.10%
发文量
75
期刊介绍: Research Synthesis Methods is a reputable, peer-reviewed journal that focuses on the development and dissemination of methods for conducting systematic research synthesis. Our aim is to advance the knowledge and application of research synthesis methods across various disciplines. Our journal provides a platform for the exchange of ideas and knowledge related to designing, conducting, analyzing, interpreting, reporting, and applying research synthesis. While research synthesis is commonly practiced in the health and social sciences, our journal also welcomes contributions from other fields to enrich the methodologies employed in research synthesis across scientific disciplines. By bridging different disciplines, we aim to foster collaboration and cross-fertilization of ideas, ultimately enhancing the quality and effectiveness of research synthesis methods. Whether you are a researcher, practitioner, or stakeholder involved in research synthesis, our journal strives to offer valuable insights and practical guidance for your work.
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