The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials
Open accessAbstract
Objectives: To discuss methods of preservation of treatment fidelity in health behavior change trials conducted in public health contexts. Methods: The treatment fidelity framework provided by the National Institutes of Health's Behavioral Change Consortium includes five domains of treatment fidelity (Study Design, Training, Delivery, Receipt, and Enactment). A measure of treatment fidelity was previously developed and validated using these categories. Results: Strategies for assessment, monitoring, and enhancing treatment fidelity within each of the five treatment fidelity domains are discussed. The previously created measure of treatment fidelity is updated to include additional items on selecting providers, additional confounders, theory testing, and multicultural considerations. Conclusions: Implementation of a treatment fidelity plan may require extra staff time and costs. However, the economic and scientific costs of lack of attention to treatment fidelity are far greater than the costs of treatment fidelity implementation. Maintaining high levels of treatment fidelity with flexible adaptation according to setting, provider, and patient is the goal for public health trials.
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Fidelity of 80 to 100% was considered high fidelity.
“fidelity of 80 to 100% will be considered high fidelity.30”
From Cancer and Aging: Reflections for Elders (CARE): A pilot randomized controlled trial of a psychotherapy intervention for older adults with cancer (2019) · cites this paper as [30]
Conclusive statements about treatment effectiveness cannot be drawn without consideration of treatment fidelity.
“Conclusive statements about treatment effectiveness cannot be drawn without consideration of treatment fidelity (Borrelli, 2011; Murphy & Gutman, 2012).”
From Acceptance and commitment therapy interventions in secondary schools and their impact on students' mental health and well-being: A systematic review (2022) · cites this paper as Borrelli, 2011
No direct visual observation of intervention sessions was conducted to assess treatment fidelity.
“We did not conduct any direct visual observation of intervention sessions to assess treatment fidelity for pragmatic reasons (including the desire to avoid anxiety-provoking study procedures in an already anxious group and to reduce potential demand characteristics).136”
From Acceptance and commitment therapy for older people with treatment-resistant generalised anxiety disorder: The FACTOID feasibility study (2021) · cites this paper as [136]
The Treatment Delivery section discusses objective monitoring of treatment fidelity using audio or video recordings, but it does not describe the citing authors’ intervention sessions. It therefore cannot verify that they conducted no direct visual observation or that they avoided it for the stated pragmatic reasons (searched: direct observation, anxiety, demand characteristics). (LLM, conf=0.77)
Experimental — accuracy not yet measured
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- Authors
- Borrelli, B.
- Affiliations
- Brown University (US)
- Corresponding author
- Borrelli, Belinda
- ORCID
- Borrelli, Belinda
- Venue
- Journal of Public Health Dentistry
- Publisher
- Wiley
- Published
- 2011-01
- Volume
- 71
- Issue
- s1
- Pages
- S52-63
- ISSN
- 0022-4006 (ISSN-L)
- 1752-7325
- PMC
- PMC3074245
- OpenAlex
- W1900001422
- Cited by
- 970
- References
- 49
- Citations by year
- 2026: 56 · 2025: 90 · 2024: 98 · 2023: 91 · 2022: 101 · 2021: 105 · 2020: 129 · 2019: 63 · 2018: 52 · 2017: 41 · 2016: 46 · 2015: 27 · 2014: 28 · 2013: 20 · 2012: 15
- FWCI
- 41.26
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Public Health Dentistry (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Dental and Craniofacial Research (U54DE019275)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Psychology › Applied Psychology › Behavioral Health and Interventions
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- intervention fidelity, health behavior change interventions, intervention delivery, provider training, theory testing, multicultural considerations
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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