Cited by 369Statistical Methods in Clinical TrialsHealth Policy Implementation ScienceEthics in Clinical Research

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Usual and Unusual Care: Existing Practice Control Groups in Randomized Controlled Trials of Behavioral Interventions

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Freedland, Kenneth E., Mohr, David C., Davidson, Karina W., Schwartz, Joseph E.·2011·Psychosomatic Medicine

DOI 10.1097/psy.0b013e318218e1fbPMC PMC3091006

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Abstract

Objective: To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Method: Selective qualitative review. Results: Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusions: This review highlights the need for a scientific consensus statement on control groups in behavioral trials. CUC = constrained usual care; EP = existing practice; EUC = enhanced usual care; eEUC = extensively enhanced usual care; HIV = human immunodeficiency virus; IC = inadequate care; iSOC = individualized standard of care; mEUC = minimally enhanced usual care; PMR = progressive muscle relaxation; RC = routine care; RCT = randomized controlled trial; SC = standard care; SOC = standard of care; uSOC = uniform standard care; STR = standardized treatment regimen; TAU = treatment-as-usual; UC = usual care

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Authors: Freedland, K. E., Mohr, D. C., Davidson, K. W., & Schwartz, J. E.
Affiliations: Washington University in St. Louis (US)
Northwestern University (US)
Corresponding author: Freedland, Kenneth E.
ORCID: Freedland, Kenneth E.
Mohr, David C.
Davidson, Karina W.
Schwartz, Joseph E.
Venue: Psychosomatic Medicine
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2011-05
Volume: 73
Issue: 4
Pages: 323-335
ISSN: 0033-3174 (ISSN-L)
DOI: 10.1097/psy.0b013e318218e1fb
PMC: PMC3091006
OpenAlex: W2062803353
Cited by: 369
References: 132
Citations by year: 2026: 26 · 2025: 22 · 2024: 14 · 2023: 22 · 2022: 34 · 2021: 64 · 2020: 37 · 2019: 27 · 2018: 28 · 2017: 18 · 2016: 19 · 2015: 14 · 2014: 18 · 2013: 15 · 2012: 9
FWCI: 2.07
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Psychosomatic Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Heart, Lung, and Blood Institute (R01HL091918)
National Center for Research Resources (UL1RR025741)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (RL1HD058295)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Keywords: usual care, standard of care, control groups, behavioral interventions, randomized controlled trials, trial design, trial conduct, research ethics, enhanced usual care
MeSH terms: Behavior Therapy, Humans, Research Design, Confounding Factors, Epidemiologic, Randomized Controlled Trials as Topic, Evidence-Based Medicine, Control Groups, Behavioral Research, Standard of Care

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Usual and Unusual Care: Existing Practice Control Groups in Randomized Controlled Trials of Behavioral Interventions

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