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Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.

Publication ,  Journal Article
Federico, CA; Heagerty, PJ; Lantos, J; O'Rourke, P; Rahimzadeh, V; Sugarman, J; Weinfurt, K; Wendler, D; Wilfond, BS; Magnus, D
Published in: Contemp Clin Trials
April 2022

Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.

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Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

April 2022

Volume

115

Start / End Page

106703

Location

United States

Related Subject Headings

  • Research Personnel
  • Research Design
  • Randomized Controlled Trials as Topic
  • Public Health
  • Pragmatic Clinical Trials as Topic
  • Humans
  • General Clinical Medicine
  • Control Groups
  • Cluster Analysis
  • 42 Health sciences
 

Citation

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ICMJE
MLA
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Federico, C. A., Heagerty, P. J., Lantos, J., O’Rourke, P., Rahimzadeh, V., Sugarman, J., … Magnus, D. (2022). Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials. Contemp Clin Trials, 115, 106703. https://doi.org/10.1016/j.cct.2022.106703
Federico, Carole A., Patrick J. Heagerty, John Lantos, Pearl O’Rourke, Vasiliki Rahimzadeh, Jeremy Sugarman, Kevin Weinfurt, David Wendler, Benjamin S. Wilfond, and David Magnus. “Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.Contemp Clin Trials 115 (April 2022): 106703. https://doi.org/10.1016/j.cct.2022.106703.
Federico CA, Heagerty PJ, Lantos J, O’Rourke P, Rahimzadeh V, Sugarman J, et al. Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials. Contemp Clin Trials. 2022 Apr;115:106703.
Federico, Carole A., et al. “Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.Contemp Clin Trials, vol. 115, Apr. 2022, p. 106703. Pubmed, doi:10.1016/j.cct.2022.106703.
Federico CA, Heagerty PJ, Lantos J, O’Rourke P, Rahimzadeh V, Sugarman J, Weinfurt K, Wendler D, Wilfond BS, Magnus D. Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials. Contemp Clin Trials. 2022 Apr;115:106703.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

April 2022

Volume

115

Start / End Page

106703

Location

United States

Related Subject Headings

  • Research Personnel
  • Research Design
  • Randomized Controlled Trials as Topic
  • Public Health
  • Pragmatic Clinical Trials as Topic
  • Humans
  • General Clinical Medicine
  • Control Groups
  • Cluster Analysis
  • 42 Health sciences