The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel

J Clin Epidemiol. 2019 Jun;110:74-81. doi: 10.1016/j.jclinepi.2019.02.011. Epub 2019 Feb 28.

Abstract

Objectives: To provide recommendations for the selection of comparators for randomized controlled trials of health-related behavioral interventions.

Study design and setting: The National Institutes of Health Office of Behavioral and Social Science Research convened an expert panel to critically review the literature on control or comparison groups for behavioral trials and to develop strategies for improving comparator choices and for resolving controversies and disagreements about comparators.

Results: The panel developed a Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials. The model indicates that the optimal comparator is the one that best serves the primary purpose of the trial but that the optimal comparator's limitations and barriers to its use must also be taken into account.

Conclusion: We developed best practice recommendations for the selection of comparators for health-related behavioral trials. Use of the Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials can improve the comparator selection process and help resolve disagreements about comparator choices.

Keywords: Behavioral research; Comparative effectiveness research; Control groups; Health behavior; Psychotherapy; Randomized controlled trials as topic; Research design.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural
  • Review

MeSH terms

  • Female
  • Humans
  • Male
  • Mental Disorders / diagnosis*
  • Mental Disorders / therapy*
  • National Institutes of Health (U.S.) / standards*
  • Patient Selection
  • Practice Guidelines as Topic*
  • Psychotherapy / methods
  • Randomized Controlled Trials as Topic
  • Research Design
  • United States