Usual and Unusual Care: Existing Practice Control Groups in Randomized Controlled Trials of Behavioral Interventions
Open accessAbstract
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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The EUC condition consisted of fatigue-specific educational materials which exceeds typical clinical offerings.
“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 [27]
The Introduction’s “Existing-Practice Comparison Groups” section defines enhanced usual care as protocol-improved care that can differ from routine care, and gives a patient education booklet as an example. It does not describe REVITALIZE’s EUC condition, establish that its materials were fatigue-specific, or compare those materials with typical clinical offerings. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIf the goal of a trial is to see if an intervention is superior to existing practices, it must be compared with them.
“if the goal of a trial is to see if an intervention is superior to existing practices (in this case, UC), it must be compared with them.43”
From Multisite Randomized Controlled Trial of CareSTEPS: A Supportive Care Intervention for the Family Caregivers of Patients With Advanced Lung Cancer (2024) · cites this paper as [43]
Attention control conditions can have unintended detrimental effects.
“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 [27]
The Introduction’s “Attention, Expectancy, and Existing Practice Controls” section questions when an attention-control arm is necessary and notes its added cost and exposure to experimentation. It does not say that attention-control conditions can have unintended detrimental effects. Searches for adverse effects, harm, and worsened outcomes found no passage making that point. (LLM, conf=0.69)
Experimental — accuracy not yet measuredParticipants were randomly assigned using block randomization to intervention or minimally enhanced usual care.
“half of the participants were randomly assigned (using block randomization) to receive a brief motivational intervention plus a referral resource list (n = 206); the other half (n = 197) received usual care plus a referral resource list (minimally enhanced usual care or mEUC; Freedland et al., 2011).”
From Screening and Brief Intervention for Substance Misuse: Does It Reduce Aggression and HIV-Related Risk Behaviours? (2015) · cites this paper as Freedland et al., 2011
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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.
- Venue
- Psychosomatic Medicine
- Published
- 2011-05
- Volume
- 73
- Issue
- 4
- Pages
- 323-335
- ISSN
- 0033-3174 (ISSN-L)
- 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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