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骨科研究中的利益冲突。科学报告中研究结果与资金之间的关联。

Conflict of interest in orthopaedic research. An association between findings and funding in scientific presentations.

作者信息

Okike Kanu, Kocher Mininder S, Mehlman Charles T, Bhandari Mohit

机构信息

Department of Orthopaedic Surgery, Children's Hospital, Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA.

出版信息

J Bone Joint Surg Am. 2007 Mar;89(3):608-13. doi: 10.2106/JBJS.F.00994.

Abstract

BACKGROUND

Financial conflict of interest has been associated with an increased likelihood that authors will report positive study outcomes. The purpose of this study was to investigate the association between types of declared conflict of interest and reported study outcomes in orthopaedic research.

METHODS

The abstracts of all podium presentations given at the 2001 and 2002 Annual Meetings of the American Academy of Orthopaedic Surgeons were analyzed by three orthopaedic surgeons with advanced training in clinical epidemiology. The findings reported in each abstract were graded as positive, negative, neutral, or not applicable. Self-reported conflict of interest was recorded and classified.

RESULTS

Conflicts of interest were reported in 40.8% (212) of 519 abstracts. The interobserver reliability of the grading of the study findings was acceptable (intraclass correlation coefficient, 0.725). Rates of conflict of interest related to royalties, stock options, or consultant or employee status varied significantly by subspecialty field (p < 0.001). The overall rate of positive study findings was 84.0% (436 of the 519 abstracts). Positive findings were more common in studies authored by individuals with a conflict of interest related to royalties (98.4% [sixty of sixty-one] compared with 88.0% [381 of 433] for studies authored by individuals without a conflict of interest related to royalties; relative risk = 1.1 [95% confidence interval = 1.0 to 1.1]; p = 0.02), in studies authored by individuals with a conflict of interest related to stock options (100.0% [twenty-nine of twenty-nine] compared with 84.7% [394 of 465]; relative risk = 1.2 [95% confidence interval = 1.0 to 1.3]; p = 0.04), and in studies authored by individuals with a conflict of interest related to consultant or employee status (97.8% [ninety-one of ninety-three] compared with 89.0% [357 of 401]; relative risk = 1.1 [95% confidence interval = 1.0 to 1.2]; p = 0.01). Positive findings were not more common in studies authored by individuals with a conflict of interest related to research or institutional funding (93.5% [143 of 153] compared with 91.8% [313 of 341]; relative risk = 1.0 [95% confidence interval = 0.95 to 1.5]; p = 0.65). In the multivariate analysis, the factors that remained significant predictors of positive outcomes were royalties (p = 0.002) and consultant or employee status (p = 0.038).

CONCLUSIONS

Self-reported conflicts of interest are common in orthopaedic research, particularly in the subspecialty fields of adult reconstruction of the knee, adult reconstruction of the hip, and spine. Presentations authored by individuals with a conflict of interest related to royalties, stock options, or consulting or employee status were significantly more likely to describe positive findings. While there may be distinct benefits associated with industry support of orthopaedic research, safeguards must be established to maintain public trust in the medical research establishment.

摘要

背景

经济利益冲突与作者报告阳性研究结果的可能性增加有关。本研究的目的是调查骨科研究中所声明的利益冲突类型与报告的研究结果之间的关联。

方法

由三名接受过临床流行病学高级培训的骨科外科医生对在2001年和2002年美国骨科医师学会年会上进行的所有大会发言的摘要进行分析。每个摘要中报告的研究结果被分为阳性、阴性、中性或不适用。记录并分类自我报告的利益冲突。

结果

519篇摘要中有40.8%(212篇)报告了利益冲突。研究结果分级的观察者间可靠性是可接受的(组内相关系数为0.725)。与版税、股票期权或顾问或员工身份相关的利益冲突发生率在不同亚专业领域有显著差异(p<0.001)。研究结果呈阳性的总体比例为84.0%(519篇摘要中的436篇)。在与版税相关的利益冲突的个人所撰写的研究中,阳性结果更为常见(98.4%[61篇中的60篇],而在与版税无关的利益冲突的个人所撰写的研究中为88.0%[433篇中的381篇];相对风险=1.1[95%置信区间=1.0至1.1];p=0.02),在与股票期权相关的利益冲突的个人所撰写的研究中(100.0%[29篇中的29篇],而在与股票期权无关的利益冲突的个人所撰写的研究中为84.7%[465篇中的394篇];相对风险=1.2[95%置信区间=1.0至1.3];p=0.04),以及在与顾问或员工身份相关的利益冲突的个人所撰写的研究中(97.8%[93篇中的91篇],而在与顾问或员工身份无关的利益冲突的个人所撰写的研究中为89.0%[401篇中的357篇];相对风险=1.1[95%置信区间=1.0至1.2];p=0.01)。在与研究或机构资助相关的利益冲突的个人所撰写的研究中,阳性结果并不更常见(93.5%[153篇中的143篇],而在与研究或机构资助无关的利益冲突的个人所撰写的研究中为91.8%[341篇中的313篇];相对风险=1.0[95%置信区间=0.95至1.5];p=0.65)。在多变量分析中,仍然是阳性结果显著预测因素的因素是版税(p=0.002)和顾问或员工身份(p=0.038)。

结论

自我报告的利益冲突在骨科研究中很常见,尤其是在膝关节成人重建、髋关节成人重建和脊柱等亚专业领域。与版税、股票期权或咨询或员工身份相关的利益冲突的个人所撰写的发言显著更有可能描述阳性结果。虽然骨科研究的行业支持可能有明显的好处,但必须建立保障措施以维持公众对医学研究机构的信任。

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