Cited by 218Statistical Methods in Clinical TrialsHealth Policy Implementation ScienceMeta-analysis and systematic reviews

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

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Freedland, Kenneth E., King, Abby C., Ambrosius, Walter T., Mayo-Wilson, Evan, Mohr, David C., Czajkowski, Susan M., Thabane, Lehana, Collins, Linda M., Rebok, George W., Treweek, Shaun P., Cook, Thomas D., Edinger, Jack D., Stoney, Catherine M., Campo, Rebecca A., Young-Hyman, Deborah, Riley, William T.·2019·Journal of Clinical Epidemiology

DOI 10.1016/j.jclinepi.2019.02.011PMC PMC6543841

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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 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.

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Additional file 4 of Effectiveness of a digital intervention versus alcohol information for online help-seekers in Sweden: a randomised controlled trial
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Additional file 2 of Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions
von Klinggraeff, L., Dugger, R., Okely, A. D., Lubans, D., Jago, R., Burkart, S., Weaver, R. G., Armstrong, B., Pfledderer, C. D., & Beets, M. W. (2022) · Figshare · doi:10.6084/m9.figshare.19136116
Additional file 5 of An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial
Courtney, D. B., Barwick, M. A., Amani, B., Greenblatt, A. T., Aitken, M., Krause, K. R., Andrade, B. F., BENNETT, K. J., Cleverley, K., Uliaszek, A. A., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26690899
Additional file 3 of An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial
Courtney, D. B., Barwick, M. A., Amani, B., Greenblatt, A. T., Aitken, M., Krause, K. R., Andrade, B. F., BENNETT, K. J., Cleverley, K., Uliaszek, A. A., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26690893
Additional file 3 of Effectiveness of a digital intervention versus alcohol information for online help-seekers in Sweden: a randomised controlled trial
Bendtsen, M., Åsberg, K., & McCambridge, J. (2022) · Figshare · doi:10.6084/m9.figshare.19777953
Additional file 2 of The mysterious case of the disappearing pilot study: a review of publication bias in preliminary behavioral interventions presented at health behavior conferences
von Klinggraeff, L., Ramey, K. T., Pfledderer, C. D., Burkart, S. A., Armstrong, B., Weaver, R. G., & Beets, M. W. (2023) · Figshare · doi:10.6084/m9.figshare.23647454
Additional file 1 of Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions
von Klinggraeff, L., Dugger, R., Okely, A. D., Lubans, D., Jago, R., Burkart, S., Weaver, R. G., Armstrong, B., Pfledderer, C. D., & Beets, M. W. (2022) · Figshare · doi:10.6084/m9.figshare.19136113
Additional file 1 of The mysterious case of the disappearing pilot study: a review of publication bias in preliminary behavioral interventions presented at health behavior conferences
von Klinggraeff, L., Ramey, K. T., Pfledderer, C. D., Burkart, S. A., Armstrong, B., Weaver, R. G., & Beets, M. W. (2023) · Figshare · doi:10.6084/m9.figshare.23647451
Additional file 6 of An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial
Courtney, D. B., Barwick, M. A., Amani, B., Greenblatt, A. T., Aitken, M., Krause, K. R., Andrade, B. F., BENNETT, K. J., Cleverley, K., Uliaszek, A. A., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26690902
Additional file 1 of Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial
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Additional file 2 of Effectiveness of a digital intervention versus alcohol information for online help-seekers in Sweden: a randomised controlled trial
Bendtsen, M., Åsberg, K., & McCambridge, J. (2022) · Figshare · doi:10.6084/m9.figshare.19777950
Additional file 5 of Effectiveness of a digital intervention versus alcohol information for online help-seekers in Sweden: a randomised controlled trial
Bendtsen, M., Åsberg, K., & McCambridge, J. (2022) · Figshare · doi:10.6084/m9.figshare.19777959
Additional file 1 of Effectiveness of a digital intervention versus alcohol information for online help-seekers in Sweden: a randomised controlled trial
Bendtsen, M., Åsberg, K., & McCambridge, J. (2022) · Figshare · doi:10.6084/m9.figshare.19777944
Additional file 6 of Effectiveness of a digital intervention versus alcohol information for online help-seekers in Sweden: a randomised controlled trial
Bendtsen, M., Åsberg, K., & McCambridge, J. (2022) · Figshare · doi:10.6084/m9.figshare.19777962
Additional file 3 of The mysterious case of the disappearing pilot study: a review of publication bias in preliminary behavioral interventions presented at health behavior conferences
von Klinggraeff, L., Ramey, K. T., Pfledderer, C. D., Burkart, S. A., Armstrong, B., Weaver, R. G., & Beets, M. W. (2023) · Figshare · doi:10.6084/m9.figshare.23647457
Additional file 1 of The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers
Bechthold, A. C., Azuero, A., Pisu, M., Pierce, J. Y., Williams, G. R., Taylor, R. A., Wells, R., Curry, K., Reed, R. D., Harrell, E. R., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19980625
Additional file 1 of An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial
Courtney, D. B., Barwick, M. A., Amani, B., Greenblatt, A. T., Aitken, M., Krause, K. R., Andrade, B. F., BENNETT, K. J., Cleverley, K., Uliaszek, A. A., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26690887
Additional file 2 of An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial
Courtney, D. B., Barwick, M. A., Amani, B., Greenblatt, A. T., Aitken, M., Krause, K. R., Andrade, B. F., BENNETT, K. J., Cleverley, K., Uliaszek, A. A., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26690890
Additional file 4 of An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial
Courtney, D. B., Barwick, M. A., Amani, B., Greenblatt, A. T., Aitken, M., Krause, K. R., Andrade, B. F., BENNETT, K. J., Cleverley, K., Uliaszek, A. A., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26690896
Additional file 2 of Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial
Adkins-Hempel, M., Japuntich, S. J., Chrastek, M., DUNSIGER, S. I., Breault, C., Ayenew, W., Everson‐Rose, S. A., Nijjar, P. S., Bock, B. C., Wu, W.-C., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26589075
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Authors: 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.
Affiliations: Washington University in St. Louis (US)
Stanford Medicine (US)
Wake Forest University Health Sciences (US)
Northwestern University (US)
National Institutes of Health (US)
McMaster University (CA)
Pennsylvania State University (US)
Johns Hopkins University (US)
University of Aberdeen (GB)
National Jewish Health (US)
National Heart, Lung, and Blood Institute (US)
Corresponding author: Freedland, Kenneth E.
ORCID: Freedland, Kenneth E.
King, Abby C.
Ambrosius, Walter T.
Mayo-Wilson, Evan
Mohr, David C.
Czajkowski, Susan M.
Thabane, Lehana
Collins, Linda M.
Rebok, George W.
Treweek, Shaun P.
Cook, Thomas D.
Edinger, Jack D.
Stoney, Catherine M.
Campo, Rebecca A.
Young-Hyman, Deborah
Riley, William T.
Venue: Journal of Clinical Epidemiology
Publisher: Elsevier BV
Published: 2019-06
Volume: 110
Pages: 74-81
ISSN: 0895-4356 (ISSN-L)
DOI: 10.1016/j.jclinepi.2019.02.011
PMC: PMC6543841
OpenAlex: W2918272982
Cited by: 218
References: 27
Citations by year: 2026: 32 · 2025: 35 · 2024: 37 · 2023: 34 · 2022: 36 · 2021: 21 · 2020: 17 · 2019: 6
FWCI: 15.57
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Journal of Clinical Epidemiology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
IUScholarWorks Open (Indiana University) (submittedVersion)
UNC Libraries
Funders: National Institutes of Health (Z99 HL999999)
National Heart, Lung, and Blood Institute (R01HL147862, R01HL119286)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: comparator selection, control groups, randomized controlled trials, best practice recommendations, trial design
MeSH terms: Mental Disorders, Female, Humans, Male, National Institutes of Health (U.S.), Psychotherapy, Research Design, United States, Randomized Controlled Trials as Topic, Practice Guidelines as Topic, Patient Selection

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

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