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
{"title":"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","authors":"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","doi":"10.1016/j.mayocpiqo.2023.04.010","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>To assess how inadequate reporting of cointerventions influences estimated treatment effects in recent cardiovascular trials.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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; <em>I</em><sup><em>2</em></sup>=0%). No significant association with results for blinding (ROR, 0.97; 95% CI, 0.91-1.03; <em>I</em><sup><em>2</em></sup>=66%), deviation of intended interventions (ROR, 0.98; 95% CI, 0.92-1.04; <em>I</em><sup><em>2</em></sup>=0%), or funding (ROR, 1.01; 95% CI, 0.93-1.09; <em>I</em><sup><em>2</em></sup>=0%) was found.</p></div><div><h3>Conclusion</h3><p>We conclude that trials with inadequate reporting of cointerventions showed larger treatment effect estimates, potentially indicating overestimation of therapeutic benefit.</p></div><div><h3>Trial Registration</h3><p>Prospero Identifier: CRD42017072522</p></div>","PeriodicalId":94132,"journal":{"name":"Mayo Clinic proceedings. Innovations, quality & outcomes","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10250579/pdf/","citationCount":"0","resultStr":"{\"title\":\"Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study\",\"authors\":\"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\",\"doi\":\"10.1016/j.mayocpiqo.2023.04.010\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>To assess how inadequate reporting of cointerventions influences estimated treatment effects in recent cardiovascular trials.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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; <em>I</em><sup><em>2</em></sup>=0%). No significant association with results for blinding (ROR, 0.97; 95% CI, 0.91-1.03; <em>I</em><sup><em>2</em></sup>=66%), deviation of intended interventions (ROR, 0.98; 95% CI, 0.92-1.04; <em>I</em><sup><em>2</em></sup>=0%), or funding (ROR, 1.01; 95% CI, 0.93-1.09; <em>I</em><sup><em>2</em></sup>=0%) was found.</p></div><div><h3>Conclusion</h3><p>We conclude that trials with inadequate reporting of cointerventions showed larger treatment effect estimates, potentially indicating overestimation of therapeutic benefit.</p></div><div><h3>Trial Registration</h3><p>Prospero Identifier: CRD42017072522</p></div>\",\"PeriodicalId\":94132,\"journal\":{\"name\":\"Mayo Clinic proceedings. 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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.
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