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Two Questions About the Design of Cluster Randomized Trials: A Tutorial.

Publication ,  Journal Article
Samsa, GP; Winger, JG; Cox, CE; Olsen, MK
Published in: J Pain Symptom Manage
April 2021

This is a short tutorial on two key questions that pertain to cluster randomized trials (CRTs): 1) Should I perform a CRT? and 2) If so, how do I derive the sample size? In summary, a CRT is the best option when you "must" (e.g., the intervention can only be administered to a group) or you "should" (e.g., because of issues such as feasibility and contamination). CRTs are less statistically efficient and usually more logistically complex than individually randomized trials, and so reviewing the rationale for their use is critical. The most straightforward approach to the sample size calculation is to first perform the calculation as if the design were randomized at the level of the patient and then to inflate this sample size by multiplying by the "design effect", which quantifies the degree to which responses within a cluster are similar to one another. Although trials with large numbers of small clusters are more statistically efficient than those with a few large clusters, trials with large clusters can be more feasible. Also, if results are to be compared across individual sites, then sufficient sample size will be required to attain adequate precision within each site. Sample size calculations should include sensitivity analyses, as inputs from the literature can lack precision. Collaborating with a statistician is essential. To illustrate these points, we describe an ongoing CRT testing a mobile-based app to systematically engage families of intensive care unit patients and help intensive care unit clinicians deliver needs-targeted palliative care.

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Published In

J Pain Symptom Manage

DOI

EISSN

1873-6513

Publication Date

April 2021

Volume

61

Issue

4

Start / End Page

858 / 863

Location

United States

Related Subject Headings

  • Sample Size
  • Research Design
  • Randomized Controlled Trials as Topic
  • Intensive Care Units
  • Humans
  • Critical Care
  • Cluster Analysis
  • Anesthesiology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
 

Citation

APA
Chicago
ICMJE
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Samsa, G. P., Winger, J. G., Cox, C. E., & Olsen, M. K. (2021). Two Questions About the Design of Cluster Randomized Trials: A Tutorial. J Pain Symptom Manage, 61(4), 858–863. https://doi.org/10.1016/j.jpainsymman.2020.11.019
Samsa, Gregory P., Joseph G. Winger, Christopher E. Cox, and Maren K. Olsen. “Two Questions About the Design of Cluster Randomized Trials: A Tutorial.J Pain Symptom Manage 61, no. 4 (April 2021): 858–63. https://doi.org/10.1016/j.jpainsymman.2020.11.019.
Samsa GP, Winger JG, Cox CE, Olsen MK. Two Questions About the Design of Cluster Randomized Trials: A Tutorial. J Pain Symptom Manage. 2021 Apr;61(4):858–63.
Samsa, Gregory P., et al. “Two Questions About the Design of Cluster Randomized Trials: A Tutorial.J Pain Symptom Manage, vol. 61, no. 4, Apr. 2021, pp. 858–63. Pubmed, doi:10.1016/j.jpainsymman.2020.11.019.
Samsa GP, Winger JG, Cox CE, Olsen MK. Two Questions About the Design of Cluster Randomized Trials: A Tutorial. J Pain Symptom Manage. 2021 Apr;61(4):858–863.
Journal cover image

Published In

J Pain Symptom Manage

DOI

EISSN

1873-6513

Publication Date

April 2021

Volume

61

Issue

4

Start / End Page

858 / 863

Location

United States

Related Subject Headings

  • Sample Size
  • Research Design
  • Randomized Controlled Trials as Topic
  • Intensive Care Units
  • Humans
  • Critical Care
  • Cluster Analysis
  • Anesthesiology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences