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

Bührer, Jonas; Del Giovane, Cinzia; Gencer, Baris; Adam, Luise Leonore; Lyko, Christina; Feller, Martin; Da Costa, Bruno R; Aujesky, Drahomir; Bauer, Douglas C; Rodondi, Nicolas; Moutzouri, Elisavet (2023). Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study. Mayo Clinic Proceedings: Innovations, Quality and Outcomes, 7(4), pp. 231-240. Elsevier 10.1016/j.mayocpiqo.2023.04.010

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)

UniBE Contributor:

Bührer, Jonas Samuel, Del Giovane, Cinzia, Gencer, Baris Faruk, Adam, Luise Leonore, Lyko, Christina Valérie, Feller, Martin, Da Costa, Bruno, Aujesky, Drahomir, Rodondi, Nicolas, Moutzouri Beifuss, Elisavet

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

2542-4548

Publisher:

Elsevier

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Pubmed Import

Date Deposited:

12 Jun 2023 15:53

Last Modified:

04 Jun 2024 09:46

Publisher DOI:

10.1016/j.mayocpiqo.2023.04.010

PubMed ID:

37304064

BORIS DOI:

10.48350/183335

URI:

https://boris.unibe.ch/id/eprint/183335

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