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

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

in Behavior modification / Behavioral research / Best practice / Clinical trials / Comparative effectiveness research / Comparators / Control groups / Design / Epidemiology / Female / Health / Health behavior / Humans / Intervention / Literature reviews / Male / Mental Disorders - diagnosis / Mental Disorders - therapy / National Institutes of Health (U.S.) - standards / Patient Selection / Practice Guidelines as Topic / Psychotherapy / Psychotherapy - methods / Randomization / Randomized Controlled Trials as Topic / Research Design / Researchers / Smartphones / Social sciences / Stakeholders / Studies / United States

2019

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

2019

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2019

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Journal Article

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

Czajkowski, Susan M.,

Mohr, David C.,

Stoney, Catherine M.,

Freedland, Kenneth E.,

Riley, William T.,

King, Abby C.,

Treweek, Shaun P.,

Collins, Linda M.,

Edinger, Jack D.,

Cook, Thomas D.,

Young-Hyman, Deborah,

Rebok, George W.,

Thabane, Lehana,

Ambrosius, Walter T.,

Mayo-Wilson, Evan,

Campo, Rebecca A.

2019

Overview

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

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Publisher

Elsevier Inc,Elsevier Limited

Subject

Behavior modification

/ Behavioral research

/ Best practice

/ Clinical trials

/ Comparative effectiveness research

/ Comparators

/ Control groups