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

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 language	English
Pages (from-to)	74-81
Number of pages	8
Journal	Journal of Clinical Epidemiology
Volume	110
Early online date	28 Feb 2019
DOIs	https://doi.org/10.1016/j.jclinepi.2019.02.011
Publication status	Published - Jun 2019

Bibliographical note

Funding and logistical support for the expert panel was provided by the National Institutes of Health Office of Behavioral and Social Sciences Research.

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

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Accepted Manuscript
© 2019. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
Accepted author manuscript, 636 KBLicence: CC BY-NC-ND

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

The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel. / Freedland, Kenneth E. (Corresponding Author); King, Abby C.; Ambrosius, Walter T. et al.
In: Journal of Clinical Epidemiology, Vol. 110, 06.2019, p. 74-81.

Research output: Contribution to journal › Article › peer-review

Freedland, KE, King, AC, Ambrosius, WT, Mayo-Wilson, E, Mohr, DC, Czajkowski, SM, Thabane, L, Collins, LM, Rebok, GW, Treweek, SP, Cook, TD, Edinger, JD, Stoney, CM, Campo, RA, Young-Hyman, D, Riley, WT & 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, vol. 110, pp. 74-81. https://doi.org/10.1016/j.jclinepi.2019.02.011

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abstract = "ObjectivesTo provide recommendations for the selection of comparators for randomized controlled trials of health-related behavioral interventions.Study Design and SettingThe 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.ResultsThe 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{\textquoteright}s limitations and barriers to its use must also be taken into account.ConclusionWe 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.",

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author = "Freedland, {Kenneth E.} and King, {Abby C.} and Ambrosius, {Walter T.} and Evan Mayo-Wilson and Mohr, {David C.} and Czajkowski, {Susan M.} and Lehana Thabane and Collins, {Linda M.} and Rebok, {George W.} and Treweek, {Shaun P.} and Cook, {Thomas D.} and Edinger, {Jack D.} and Stoney, {Catherine M.} and Campo, {Rebecca A.} and Deborah Young-Hyman and Riley, {William T.} and {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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AU - Mayo-Wilson, Evan

AU - Mohr, David C.

AU - Czajkowski, Susan M.

AU - Thabane, Lehana

AU - Collins, Linda M.

AU - Rebok, George W.

AU - Treweek, Shaun P.

AU - Cook, Thomas D.

AU - Edinger, Jack D.

AU - Stoney, Catherine M.

AU - Campo, Rebecca A.

AU - Young-Hyman, Deborah

AU - Riley, William T.

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

Abstract

Bibliographical note

Keywords

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