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

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

Mayo Clinic Proceedings: Innovations, Quality & Outcomes (Aug 2023)

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

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

Affiliations

Jonas Bührer, MD: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland; Department of General Internal Medicine, Inselspital, University Hospital of Bern, University of Bern, Switzerland
Cinzia Del Giovane, PhD: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland
Baris Gencer, MD, MPH: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland; Department of Cardiology, University of Geneva, Switzerland
Luise Adam, MD: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland
Christina Lyko, MD: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland
Martin Feller, MD, MSc: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland
Bruno R. Da Costa, PhD: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland; Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Institute of Health Policy, Management, and Evaluation, University of Toronto, Ontario, Canada
Drahomir Aujesky, MD, MSc: Department of General Internal Medicine, Inselspital, University Hospital of Bern, University of Bern, Switzerland
Douglas C. Bauer, MD: Departments of Medicine and Epidemiology and Biostatistics, University of California, San Francisco
Nicolas Rodondi, MD, MAS: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland; Department of General Internal Medicine, Inselspital, University Hospital of Bern, University of Bern, Switzerland
Elisavet Moutzouri, MD, PhD: Institute of Primary Health Care (BIHAM), University of Bern, Switzerland; Department of General Internal Medicine, Inselspital, University Hospital of Bern, University of Bern, Switzerland; Correspondence: Address to Elisavet Moutzouri, MD, PhD; Institute of Primary Health Care (BIHAM)/Department of General Internal Medicine Inselspital, Bern University Hospital, University of Bern, Switzerland.

Journal volume & issue: Vol. 7, no. 4
pp. 231 – 240

Abstract

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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. Trial Registration: Prospero Identifier: CRD42017072522

Published in Mayo Clinic Proceedings: Innovations, Quality & Outcomes

ISSN: 2542-4548 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Medicine (General)
Website: https://www.journals.elsevier.com/mayo-clinic-proceedings-innovations-quality-and-outcomes/

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