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Abstract：
To assess the impact of trials with potential financial conflict of interests (FCOIs) on evidence synthesis in meta-analyses (MAs).
A total of 96 MAs from the Cochrane Library about drug trials were investigated. The primary outcomes examined the proportion of conclusions that would change with the exclusion of trials with potential FCOIs. If the proportion of changed conclusions was below the non-inferiority margin of 10%, we considered that it was not inferior to include the trials with potential FCOIs in the MAs.
Only 54.17% of MAs reported the funding sources of each included trial, and in 21.88% of MAs, the author-industry-related financial ties of each included trial were reported. When trials with FCOIs were excluded, the changed conclusions of effectiveness and major adverse events were 13.16% and 11.11%, respectively, and the I2 decreased by 13.56% and 10.09%, respectively. For serious adverse events, the exclusion of FCOIs trials did not lead to any change in conclusions; however, the I2 decreased by 24.24%. The impact of trials without reported FCOIs was also examined on evidence synthesis, and the results showed that the changed conclusions of effectiveness and major adverse events were 5.26% and 6.25%, respectively, indicating non-inferiority. However, the I2 increased by 13.60% and 12.37%, respectively.
In this meta-epidemiological study, we demonstrated that trials with FCOIs may not only influence the final outcome of MAs but may also increase the heterogeneity of results. It is suggested that all MAs fully report the FCOIs involved in evidence-based research and explore the impact of its FCOIs to better provide a more valuable reference for patients, clinicians, and policy-makers.
A total of 96 MAs from the Cochrane Library about drug trials were investigated. The primary outcomes examined the proportion of conclusions that would change with the exclusion of trials with potential FCOIs. If the proportion of changed conclusions was below the non-inferiority margin of 10%, we considered that it was not inferior to include the trials with potential FCOIs in the MAs.
Only 54.17% of MAs reported the funding sources of each included trial, and in 21.88% of MAs, the author-industry-related financial ties of each included trial were reported. When trials with FCOIs were excluded, the changed conclusions of effectiveness and major adverse events were 13.16% and 11.11%, respectively, and the I2 decreased by 13.56% and 10.09%, respectively. For serious adverse events, the exclusion of FCOIs trials did not lead to any change in conclusions; however, the I2 decreased by 24.24%. The impact of trials without reported FCOIs was also examined on evidence synthesis, and the results showed that the changed conclusions of effectiveness and major adverse events were 5.26% and 6.25%, respectively, indicating non-inferiority. However, the I2 increased by 13.60% and 12.37%, respectively.
In this meta-epidemiological study, we demonstrated that trials with FCOIs may not only influence the final outcome of MAs but may also increase the heterogeneity of results. It is suggested that all MAs fully report the FCOIs involved in evidence-based research and explore the impact of its FCOIs to better provide a more valuable reference for patients, clinicians, and policy-makers.
摘要：
背景：评估具有潜在财务利益冲突（FCOI）的试验对荟萃分析（MA）中证据综合的影响。
方法：研究了Cochrane图书馆中关于药物试验的96个MA。主要结果检查了随着排除具有潜在FCOIs的试验而改变的结论比例。如果更改结论的比例低于10%的非劣效性，我们认为将具有潜在FCOIs的试验纳入MA并不逊于.
结果：只有54.17%的MA报告了每个纳入试验的资金来源，在21.88%的MA中，报告了每个纳入试验的作者与行业相关的财务关系.当FCOIs的试验被排除在外时，有效性和主要不良事件的变化结论分别为13.16%和11.11%，分别,I2分别下降13.56%和10.09%,分别。对于严重不良事件，排除FCOIs试验并没有导致结论的任何改变；然而，I2下降24.24%。没有报告FCOIs的试验的影响也在证据综合上进行了检查，结果显示，有效性和主要不良事件的变化结论分别为5.26%和6.25%，分别,表明非自卑。然而,I2分别增加了13.60%和12.37%，分别。
结论：在这项元流行病学研究中，我们证明,FCOIs试验不仅可能影响MAs的最终结局,而且可能增加结果的异质性.建议所有MA充分报告参与循证研究的FCOIs，并探讨其FCOIs的影响，以便更好地为患者提供更有价值的参考。临床医生,和政策制定者。
方法：研究了Cochrane图书馆中关于药物试验的96个MA。主要结果检查了随着排除具有潜在FCOIs的试验而改变的结论比例。如果更改结论的比例低于10%的非劣效性，我们认为将具有潜在FCOIs的试验纳入MA并不逊于.
结果：只有54.17%的MA报告了每个纳入试验的资金来源，在21.88%的MA中，报告了每个纳入试验的作者与行业相关的财务关系.当FCOIs的试验被排除在外时，有效性和主要不良事件的变化结论分别为13.16%和11.11%，分别,I2分别下降13.56%和10.09%,分别。对于严重不良事件，排除FCOIs试验并没有导致结论的任何改变；然而，I2下降24.24%。没有报告FCOIs的试验的影响也在证据综合上进行了检查，结果显示，有效性和主要不良事件的变化结论分别为5.26%和6.25%，分别,表明非自卑。然而,I2分别增加了13.60%和12.37%，分别。
结论：在这项元流行病学研究中，我们证明,FCOIs试验不仅可能影响MAs的最终结局,而且可能增加结果的异质性.建议所有MA充分报告参与循证研究的FCOIs，并探讨其FCOIs的影响，以便更好地为患者提供更有价值的参考。临床医生,和政策制定者。
