心血管试验中合并干预措施、其他方法学因素及治疗效果估计的报告不充分：一项Meta流行病学研究

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

作者信息

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

机构信息

Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.

Department of General Internal Medicine, Inselspital, University Hospital of Bern, University of Bern, Switzerland.

出版信息

Mayo Clin Proc Innov Qual Outcomes. 2023 Jun 2;7(4):231-240. doi: 10.1016/j.mayocpiqo.2023.04.010. eCollection 2023 Aug.

DOI:10.1016/j.mayocpiqo.2023.04.010

PMID:37304064

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10250579/

Abstract

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; =0%). No significant association with results for blinding (ROR, 0.97; 95% CI, 0.91-1.03; =66%), deviation of intended interventions (ROR, 0.98; 95% CI, 0.92-1.04; =0%), or funding (ROR, 1.01; 95% CI, 0.93-1.09; =0%) was found.

CONCLUSION

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

TRIAL REGISTRATION

Prospero Identifier: CRD42017072522.

摘要

目的

评估在近期心血管试验中，合并干预措施报告不充分如何影响估计的治疗效果。

方法

对2011年1月1日至2021年7月1日期间发表在5种高影响力期刊上的、评估药物干预对临床心血管结局影响的试验，系统检索Medline/Embase数据库。由2名评审员评估关于合并干预措施报告充分与否、盲法、因预期干预措施偏离导致的偏倚风险（低风险与高风险/存在一些担忧）、资金来源（非行业与行业）、设计类型（优效性与非劣效性）以及结果的信息。使用meta回归随机效应分析评估与效应大小的关联，以比值比（OR）的比值（ROR）表示。ROR>1.0表明，具有指向较低质量的方法学因素的试验报告的治疗效果估计值更大。

结果

共纳入164项试验。在这164项试验中，124项（74%）未充分报告合并干预措施；164项试验中的89项（54%）未提供关于合并干预措施的信息，164项试验中的70项（43%）因盲法不充分而存在偏倚风险。此外，164项试验中的86项（53%）因预期干预措施偏离而存在偏倚风险。在164项试验中，144项（88%）由行业资助。合并干预措施报告不充分的试验对主要终点的治疗效果估计值更大（ROR，1.08；95%CI，1.01 - 1.15；P = 0%）。未发现与盲法结果（ROR，0.97；95%CI，0.91 - 1.03；P = 66%）、预期干预措施偏离（ROR，0.98；95%CI，0.92 - 1.04；P = 0%）或资金来源（ROR，1.01；95%CI，0.93 - 1.09；P = 0%）存在显著关联。