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

Kenneth E Freedland; 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

doi:10.1016/j.jclinepi.2019.02.011

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.

Authors

Kenneth E Freedland¹, Abby C King², Walter T Ambrosius³, Evan Mayo-Wilson⁴, David C Mohr⁵, Susan M Czajkowski⁶, Lehana Thabane⁷, Linda M Collins⁸, George W Rebok⁴, Shaun P Treweek⁹, Thomas D Cook¹⁰, Jack D Edinger¹¹, Catherine M Stoney¹², Rebecca A Campo¹³, Deborah Young-Hyman¹³, William T Riley¹³; National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials

Affiliations

¹ Washington University School of Medicine, St. Louis, MO, USA. Electronic address: freedlak@wustl.edu.
² Stanford University School of Medicine, Stanford, CA, USA.
³ Wake Forest School of Medicine, Winston-Salem, NC, USA.
⁴ Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.
⁵ Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
⁶ National Cancer Institute, Bethesda, MD, USA.
⁷ McMaster University Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada.
⁸ Pennsylvania State University College of Health and Human Development, University Park, PA, USA.
⁹ University of Aberdeen Health Services Research Unit, Aberdeen, Scotland.
¹⁰ Northwestern University Institute for Policy Research, Evanston, IL, USA.
¹¹ National Jewish Health, Denver, CO, USA.
¹² National Heart, Lung, and Blood Institute, Bethesda, MD, USA.
¹³ National Institutes of Health Office of Behavioral and Social Sciences Research, Bethesda, MD, USA.

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

Abstract

Publication types

MeSH terms

Grants and funding