Introduction

CHAPTER SECTIONS

Analysis Plan


Section 1

Introduction

Contributors

Pragmatic clinical trial designs, particularly those that use cluster randomization or other novel methods, pose challenges during the study design phase (Cook et al 2016). Here, we briefly examine current challenges in the design of pragmatic trials, as well as potential solutions and future directions for further exploration.

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SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Intraclass Correlation
  3. Unequal Cluster Sizes
  4. Accounting for Residual Confounding in the Analysis
  5. Missing Data and Intention-to-Treat Analyses
  6. Electronic Health Record Data Extraction
  7. Unanticipated Changes
  8. Interim Reassessment of Sample Size in Cluster Randomized Trials
  9. Case Study: STOP CRC Trial

REFERENCES

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Cook AJ, Delong E, Murray DM, Vollmer WM, Heagerty PJ. 2016. Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core. Clin Trials. 13:504-512. doi:10.1177/1740774516646578. PMID: 27179253.

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Version History

April 30, 2024: Made nonsubstantive changes to the text as part of the annual content update (changes made D. Seils).

June 23, 2022: Updated the name of the NIH Collaboratory in the contributors list as part of the annual content update (changes made by D. Seils).

May 27, 2020: Added Heagerty to the contributors list and reordered the sections of this chapter as part the annual content update (changes made by D. Seils).

May 1, 2020: Made nonsubstantive formatting changes to the References section as part of the annual content update (changes made by D. Seils).

January 16, 2019: Made nonsubstantive changes to the text as part of the annual content update (changes made by D. Seils).

Published August 25, 2017

current section :

Introduction

  1. Introduction
  2. Intraclass Correlation
  3. Unequal Cluster Sizes
  4. Accounting for Residual Confounding in the Analysis
  5. Missing Data and Intention-to-Treat Analyses
  6. Electronic Health Record Data Extraction
  7. Unanticipated Changes
  8. Interim Reassessment of Sample Size in Cluster Randomized Trials
  9. Case Study: STOP CRC Trial

Citation:

Heagerty PJ, DeLong ER; for the NIH Health Care Systems Research Collaboratory Biostatistics and Study Design Core. Analysis Plan: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/design/analysis-plan-top/analysis-plan-introduction/. Updated October 4, 2024. DOI: 10.28929/015.