Low Reporting of Cointerventions in Recent Cardiovascular Clinical Trials: A Systematic Review.

Moutzouri, Elisavet; Adam, Luise; Feller, Martin; Syrogiannouli, Lamprini; Da Costa, Bruno R.; Del Giovane, Cinzia; Bauer, Douglas C; Aujesky, Drahomir; Chiolero, Arnaud; Rodondi, Nicolas (2020). Low Reporting of Cointerventions in Recent Cardiovascular Clinical Trials: A Systematic Review. Journal of the American Heart Association, 9(12), e014890. American Heart Association 10.1161/JAHA.119.014890

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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/PROSP​ERO/. Unique identifier: CRD42018106771.

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

UniBE Contributor:

Moutzouri, Elisavet; Adam, Luise Leonore; Feller, Martin; Syrogiannouli, Lamprini; Da Costa, Bruno; Del Giovane, Cinzia; Aujesky, Drahomir; Chiolero, Arnaud and Rodondi, Nicolas

Subjects:

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

ISSN:

2047-9980

Publisher:

American Heart Association

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

18 Jun 2020 11:19

Last Modified:

25 Jun 2020 12:04

Publisher DOI:

10.1161/JAHA.119.014890

PubMed ID:

32529888

Uncontrolled Keywords:

blinding cardiovascular trials cointerventions competing treatments reporting risk of bias

BORIS DOI:

10.7892/boris.144725

URI:

https://boris.unibe.ch/id/eprint/144725

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