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 cardiovascu...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-08-01
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| Series: | Mayo Clinic Proceedings: Innovations, Quality & Outcomes |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2542454823000267 |
| _version_ | 1797744337900011520 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jonas Bührer, MD |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-03-12T15:08:18Z |
| format | Article |
| id | doaj.art-840b1228aca044d7b6fca9617de08f8c |
| institution | Directory Open Access Journal |
| issn | 2542-4548 |
| language | English |
| last_indexed | 2024-03-12T15:08:18Z |
| publishDate | 2023-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Mayo Clinic Proceedings: Innovations, Quality & Outcomes |
| spelling | doaj.art-840b1228aca044d7b6fca9617de08f8c2023-08-12T04:34:35ZengElsevierMayo Clinic Proceedings: Innovations, Quality & Outcomes2542-45482023-08-0174231240Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological StudyJonas Bührer, MD0Cinzia Del Giovane, PhD1Baris Gencer, MD, MPH2Luise Adam, MD3Christina Lyko, MD4Martin Feller, MD, MSc5Bruno R. Da Costa, PhD6Drahomir Aujesky, MD, MSc7Douglas C. Bauer, MD8Nicolas Rodondi, MD, MAS9Elisavet Moutzouri, MD, PhD10Institute of Primary Health Care (BIHAM), University of Bern, Switzerland; Department of General Internal Medicine, Inselspital, University Hospital of Bern, University of Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, Switzerland; Department of Cardiology, University of Geneva, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, SwitzerlandInstitute of Primary Health Care (BIHAM), University of Bern, SwitzerlandInstitute 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, CanadaDepartment of General Internal Medicine, Inselspital, University Hospital of Bern, University of Bern, SwitzerlandDepartments of Medicine and Epidemiology and Biostatistics, University of California, San FranciscoInstitute of Primary Health Care (BIHAM), University of Bern, Switzerland; Department of General Internal Medicine, Inselspital, University Hospital of Bern, University of Bern, SwitzerlandInstitute 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.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: CRD42017072522http://www.sciencedirect.com/science/article/pii/S2542454823000267 |
| spellingShingle | 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 Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study Mayo Clinic Proceedings: Innovations, Quality & Outcomes |
| title | Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study |
| title_full | Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study |
| title_fullStr | Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study |
| title_full_unstemmed | Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study |
| title_short | Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study |
| title_sort | inadequate reporting of cointerventions other methodological factors and treatment estimates in cardiovascular trials a meta epidemiological study |
| url | http://www.sciencedirect.com/science/article/pii/S2542454823000267 |
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