Reproducibility of clinical research in critical care: a scoping review

Daniel J Niven; T Jared McCormick; Sharon E Straus; Brenda R Hemmelgarn; Lianne Jeffs; Tavish R M Barnes; Henry T Stelfox

doi:10.1186/s12916-018-1018-6

Reproducibility of clinical research in critical care: a scoping review

BMC Med. 2018 Feb 21;16(1):26. doi: 10.1186/s12916-018-1018-6.

Authors

Daniel J Niven¹, T Jared McCormick², Sharon E Straus³, Brenda R Hemmelgarn⁴, Lianne Jeffs⁵, Tavish R M Barnes⁶, Henry T Stelfox⁶

Affiliations

¹ Department of Critical Care Medicine, University of Calgary, 3134 Hospital Drive NW, Calgary, AB, T2N 2T9, Canada. daniel.niven@albertahealthservices.ca.
² Department of Anesthesiology and Pain Medicine, University of Ottawa, 1053 Carling Avenue, B302, Ottawa, ON, K1Y 4E9, Canada.
³ Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
⁴ Department of Community Health Sciences, University of Calgary, 3280 Hospital Drive NW, Calgary, AB, T2N 4Z6, Canada.
⁵ St. Michael's Hospital Volunteer Association Chair in Nursing and Scientist with the Keenan Research Center, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Institute of Health Policy Management and Faculty of Nursing, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
⁶ Department of Critical Care Medicine, University of Calgary, 3134 Hospital Drive NW, Calgary, AB, T2N 2T9, Canada.

Abstract

Background: The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies.

Methods: We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants.

Results: Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33-50%). Original studies reported larger effects than reproduction attempts (primary endpoint, risk difference 16.0%, 95% CI 11.6-20.5% vs. 8.4%, 95% CI 6.0-10.8%, P = 0.003). More than half of clinical practices with a reproduction attempt demonstrated effects that were inconsistent with the original study (56%, 95% CI 42-68%), among which a large number were reported to be efficacious in the original study and to lack efficacy in the reproduction attempt (34%, 95% CI 19-52%). Two practices reported to be efficacious in the original study were found to be harmful in the reproduction attempt.

Conclusions: A minority of critical care practices with research published in high-profile journals were evaluated for reproducibility; less than half had reproducible effects.

Keywords: Adoption; Critical care; De-adoption; ICU; Intensive care; Replication research; Reproducibility.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Biomedical Research / methods*
Critical Care / methods*
Humans
Intensive Care Units
Reproducibility of Results