心血管试验中联合干预、其他方法学因素和治疗估计报告不足：一项荟萃流行病学研究

Mayo Clinic proceedings. Innovations, quality & outcomes Pub Date : 2023-08-01 DOI:10.1016/j.mayocpiqo.2023.04.010

Jonas Bührer MD , Cinzia Del Giovane PhD , Baris Gencer MD, MPH , Luise Adam MD , Christina Lyko MD , Martin Feller MD, MSc , Bruno R. Da Costa PhD , Drahomir Aujesky MD, MSc , Douglas C. Bauer MD , Nicolas Rodondi MD, MAS , Elisavet Moutzouri MD, PhD

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引用次数: 0

摘要

目的评估在最近的心血管试验中，联合干预的报告不足如何影响估计的治疗效果。方法从2011年1月1日至2021年7月1日，系统检索Medline/Ebase在5种高影响力期刊上发表的评估药物干预对临床心血管结果的试验。由2名评审员评估了关于联合干预、致盲、因预期干预（低干预与高干预/一些问题）、资金（非行业干预与行业干预）、设计（优缺点干预与非劣缺点干预）偏差而导致的偏倚风险的充分报告与不充分报告的信息，以及结果。使用元回归随机效应分析评估与效应大小的相关性，用比值比（ROR）表示。>；1.0表明，方法因素指向较低质量的试验报告了较大的治疗估计值。结果共纳入164项试验。在164项试验中，124项（74%）没有充分报告联合干预；164项试验中有89项（54%）没有提供有关联合干预的信息，164项试验（43%）中有70项（43%）因盲法不足而存在偏倚风险。此外，164人中有86人（53%）因偏离预期干预措施而有偏倚的风险。在164项试验中，144项（88%）由行业资助。联合干预报告不足的试验对主要终点的治疗估计值较大（ROR，1.08；95%CI，1.01-1.15；I2=0%）。未发现与盲法（ROR，0.97；95%CI，0.91-1.03；I2=66%）、预期干预措施偏差（ROR：0.98；95%CI：0.92-1.04；I2=0%）或资金（ROR为1.01；95%CI为0.93-1.09；I2=0%）的结果有显著关联。结论我们得出的结论是，联合干预报告不足的试验显示出更大的治疗效果估计，这可能表明高估了治疗效益。试用注册Prospero标识符：CRD42017072522

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Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study

Objective

To assess how inadequate reporting of cointerventions influences estimated treatment effects in recent cardiovascular trials.

Methods

Medline/Embase were systematically searched from January 1, 2011 to July 1, 2021 for trials evaluating pharmacologic interventions on clinical cardiovascular outcomes published in 5 high-impact journals. Information on adequate vs inadequate reporting of cointerventions, blinding, risk of bias due to deviations of intended interventions (low vs high/some concerns), funding (nonindustry vs industry), design (superiority vs noninferiority), and results were assessed by 2 reviewers. The association with effect sizes was assessed using meta-regression random-effect analysis, expressed as ratios of odds ratios (ROR). RORs of >1.0 indicated that trials with the methodological factor pointing to lower quality report larger treatment estimates.

Results

In total, 164 trials were included. Of the 164 trials, 124 (74%) did not adequately report cointerventions; 89 of the 164 trials (54%) provided no information regarding cointerventions, and 70 of the 164 (43%) were at risk of bias due to inadequate blinding. Moreover, 86 of the 164 (53%) were at risk of bias due to deviation of intended interventions. Of the 164 trials, 144 (88%) were funded by the industries. Trials with inadequate reporting of cointerventions had larger treatment estimates for the primary end point (ROR, 1.08; 95% CI, 1.01-1.15; I²=0%). No significant association with results for blinding (ROR, 0.97; 95% CI, 0.91-1.03; I²=66%), deviation of intended interventions (ROR, 0.98; 95% CI, 0.92-1.04; I²=0%), or funding (ROR, 1.01; 95% CI, 0.93-1.09; I²=0%) was found.

Conclusion

We conclude that trials with inadequate reporting of cointerventions showed larger treatment effect estimates, potentially indicating overestimation of therapeutic benefit.