Probst Pascal, Knebel Phillip, Grummich Kathrin, Tenckhoff Solveig, Ulrich Alexis, Büchler Markus W, Diener Markus K
*Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany†The Study Center of the German Surgical Society (SDGC), University of Heidelberg, Heidelberg, Germany.
Ann Surg. 2016 Jul;264(1):87-92. doi: 10.1097/SLA.0000000000001372.
Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated.
A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed.
A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P < 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13-15.68; P < 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P < 0.001).
Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.
行业赞助已被视为医学科学多个领域的偏倚来源。迄今为止，尚未评估行业赞助在普通外科和腹部外科领域的影响。
在考克兰图书馆、医学期刊数据库和荷兰医学文摘数据库中进行了系统的文献检索（1985 - 2014年），以识别普通外科和腹部外科的随机对照试验。提取了有关资金来源、结果和方法学质量的信息。行业赞助与阳性结果的关联以比值比（OR）及95%置信区间（CI）表示。进行了χ检验以及包含研究特征和已知偏倚来源的多变量逻辑回归分析。
共筛选了7934篇文章，纳入了165项随机对照试验。未发现方法学质量存在差异。行业资助的试验更常呈现出主要终点具有统计学显著意义的结果（OR，2.44；CI，1.04 - 5.71；P = 0.04）。115项（76.5%）行业资助的试验中有88项以及50项（38.0%）非行业资助的试验中有19项报告了阳性结果（OR，5.32；CI，2.60 - 10.88；P < 0.001）。行业资助的试验更常报告阳性结果但无统计学依据（OR，5.79；CI，2.13 - 15.68；P < 0.001）。在多变量分析中，资金来源与阳性结果的报告仍显著相关（P < 0.001）。
外科试验的行业资助导致对结果的阳性报告夸大。本研究强调了声明资金来源的必要性。行业参与外科研究必须确保科学诚信和独立性，且必须基于完全透明。
