The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.
The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel
Open accessAbstract
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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“We considered an alternative comparison condition to control for attention, but it would not reflect current clinical realities and attention control conditions can have unintended detrimental effects [26 -28].”
From Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue (2023) · cites this paper as [26]
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In the citing paper
“We compared REVITALIZE to an EUC condition consisting of fatigue-specific educational materials which exceeds typical clinical offerings [26,27]”
From Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue (2023) · cites this paper as [26]
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“Studies with non-therapeutic control conditions are still scientifically valuable as they can establish the impact of non-specific factors12, but they cannot provide the highest comparison strength.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [12]
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“There is no single control condition that is appropriate for every study at every stage of the research process11,12,39.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [12]
In the citing paper
“Clarifying the universe of mHealth control condition types can help highlight the scientific questions each type can reasonably address and comparison strength each type provides12.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [12]
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“The choice of control condition heavily impacts the comparison strength within a study12.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [12]
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Metadata
- 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
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2019-06
- Volume
- 110
- Pages
- 74-81
- ISSN
- 0895-4356 (ISSN-L)
- 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
- 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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