Journal article
Low Reporting of Cointerventions in Recent Cardiovascular Clinical Trials: A Systematic Review.
- Moutzouri E Institute of Primary Health Care University of Bern Bern, Switzerland.
- Adam L Department of General Internal Medicine Inselspital University Hospital of Bern University of Bern Bern, Switzerland.
- Feller M Institute of Primary Health Care University of Bern Bern, Switzerland.
- Syrogiannouli L Institute of Primary Health Care University of Bern Bern, Switzerland.
- Da Costa BR Institute of Primary Health Care University of Bern Bern, Switzerland.
- Del Giovane C Institute of Primary Health Care University of Bern Bern, Switzerland.
- Bauer DC Departments of Medicine and Epidemiology and Biostatistics University of California, San Francisco CA.
- Aujesky D Department of General Internal Medicine Inselspital University Hospital of Bern University of Bern Bern, Switzerland.
- Chiolero A Institute of Primary Health Care University of Bern Bern, Switzerland.
- Rodondi N Institute of Primary Health Care University of Bern Bern, Switzerland.
- 2020-06-13
Published in:
- Journal of the American Heart Association. - 2020
English
Background A cointervention in a randomized clinical trial (RCT) is medical care given in addition to the tested intervention. If cointerventions are unbalanced between trial arms, the results may be biased. We hypothesized that cointerventions would be more adequately reported in RCTs without full blinding or at risk of bias. Methods and Results To describe the reporting of cointerventions and to evaluate the factors associated with their reporting, we did a systematic search of all RCTs evaluating pharmacological interventions on cardiovascular outcomes published in 5 high-impact journals. The reporting of cointerventions, blinding, and risk of bias were extracted and evaluated independently by 2 reviewers (E.M., L.A.). Cointerventions were inadequately reported in 87 of 123 RCTs (70.7%), with 56 (45.5%) providing no information on cointerventions and 31 (25.2%) providing only partial information. Of the RCTs, 52 (42.3%) had inadequate blinding of participants and/or personnel and 63 (51.2%) of the RCTs were judged at risk of bias. In univariable analysis, the reporting of cointerventions was not associated with blinding of participants and/or personnel (odds ratio [OR], 1.04; 95% CI, 0.47-2.27 for adequately versus inadequately blinded trials) or with risk of bias (OR, 1.47; 95% CI, 0.67-3.21 for at low risk of bias versus trials at risk of bias). In multivariable analysis, only a follow-up of <1 month was associated with the adequate reporting of cointerventions (OR, 3.63; 95% CI, 1.21-10.91). Conclusions More than two-thirds of recent major cardiovascular trials did not adequately report cointerventions. The quality of reporting was not better among trials that were not fully blinded or at risk for bias. Registration URL: https://www.crd.york.ac.uk/PROSPERO/. Unique identifier: CRD42018106771.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1161/JAHA.119.014890
- PMID 32529888
- Persistent URL
- https://sonar.ch/global/documents/279212
Statistics
Document views: 39
File downloads: