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

Kenneth E. Freedland (Corresponding Author), Abby C. King, Walter T. Ambrosius, Evan Mayo-Wilson, David C. Mohr, Susan M. Czajkowski, Lehana Thabane, Linda M. Collins, George W. Rebok, Shaun P. Treweek, Thomas D. Cook, Jack D. Edinger, Catherine M. Stoney, Rebecca A. Campo, Deborah Young-Hyman, William T. Riley, National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials

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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 (OBSSR) 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 to resolve disagreements about comparator choices.
Original languageEnglish
Pages (from-to)74-81
Number of pages8
JournalJournal of Clinical Epidemiology
Volume110
Early online date28 Feb 2019
DOIs
Publication statusPublished - Jun 2019

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Keywords

  • behavioral research
  • comparative effectiveness research
  • control groups
  • health behavior
  • psychotherapy
  • randomized controlled trials as topic
  • research design
  • Control groups
  • Psychotherapy
  • Comparative effectiveness research
  • Behavioral research
  • Randomized controlled trials as topic
  • Health behavior
  • Research design
  • PLACEBO
  • CLINICAL-TRIALS

ASJC Scopus subject areas

  • Epidemiology

Cite this

Freedland, K. E., King, A. C., Ambrosius, W. T., Mayo-Wilson, E., Mohr, D. C., Czajkowski, S. M., Thabane, L., Collins, L. M., Rebok, G. W., Treweek, S. P., Cook, T. D., Edinger, J. D., Stoney, C. M., Campo, R. A., Young-Hyman, D., Riley, W. T., & National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials (2019). The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel. Journal of Clinical Epidemiology, 110, 74-81. https://doi.org/10.1016/j.jclinepi.2019.02.011