Partner Introduction (PASSERELLE): 2-min video. 

• Summary: Yvonne Pelling (Patient & Community Engagement Lead) introduces the PASSERELLE SPOR National Training Entity, a Canadian-wide hub acting as a network of networks in capacity development funded under the Canadian Institute for Health Research’s (CIHR’s) Strategy for Patient-Oriented Research (SPOR) initiative.

University of Oxford Podcasts - Not just "what," but also "how well:" Intervention fidelity in clinical trials of complex interventions in healthcare (January 28, 2025): 19-min section of 42-min webinar (first 19-min)

• Summary: Dr. Arsenio Paez discusses intervention fidelity, which is the correspondence between the intervention that was planned for the study and what was actually delivered in the pragmatic trial. The related concept of participant adherence (to the intervention) is described, and the stage is also set for considerations relating to the impact of low fidelity on estimated intervention effects.

Patient-Centered Outcomes Research Institute (PCORI). Lessons Learned (Balancing Flexibility and Fidelity in Pragmatic Trials): 1-page website.

• Summary: Drs. Jeanne Hoffman and Jesse Fann provide advice when considering the balance of intervention flexibility and fidelity in pragmatic trials. (Intervention fidelity refers to the degree to which the intervention is consistently delivered as intended, ensuring adherence to the protocol while also accounting for real-world variability in settings and implementation.) It is recommended that researchers: (1) Be flexible in their approach to fidelity in pragmatic trials; (2) At the outset of a pragmatic trial, identify the core components of an intervention that are most important to adhere to; (3) Reflect upon which data will be most meaningful to capture to assess the implementation process, and map out up front how to collect it in a pragmatic way; (4) Examine the fidelity process early on so that adaptations can be made if needed; and (5) Be proactive in identifying implementation issues and encourage partners to help address problems. 

NIH Pragmatic Trials Collaboratory (Living Textbook): Section 4 - Frameworks for Monitoring Fidelity and Adaptations (Chapter: Data, Tools, & Conduct - Monitoring Intervention Fidelity and Adaptations): 1-page website.

• Summary: Introduces formal frameworks to monitor intervention fidelity and adaptations in a pragmatic trial: i.e., The Framework for Reporting Adaptations and Modifications-Enhanced (FRAME), the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, the Practical Robust Implementation and Sustainability Model (PRISM), and an approach called Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE).

Dr. Russ Glasgow describing the RE-AIM Framework (March 7, 2019 via “Implementation Science Video Library”): 10-minute webinar.

• Summary: Summarizes the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, which is used for both planning and evaluation of interventions. Reach: Who is intended to benefit and who actually participates or is exposed to the intervention? Effectiveness: What is the most important benefit you are trying to achieve and what is the likelihood of negative outcomes? Adoption: Where is the program or policy applied and who is applying it? Implementation: How consistently is the program or policy delivered? How will it be adapted? How much will it cost? Why will the results come about? Maintenance: When will the initiative become operational? How long will it be sustained (setting-level), and how are the results sustained (individual-level)?

Curtis LH, et al. Addressing guideline and policy changes during pragmatic clinical trials. Clin Trials. 2019 Aug;16(4):431-437. (7-page paper)

• Summary: Using examples from the NIH’s Health Care Systems Research Collaboratory trial portfolio, this paper illustrates two important types of changes - external to the trial - that can have an impact on clinical practice and the conduct of pragmatic trials embedded in routine care: changes in (1) Clinical practice guidelines, and changes in (2) Medical reimbursement policies (that affect behavior of clinicians/those implementing the intervention in the trial). Recommendations are provided for researchers faced with these types of challenges during the implementation and management of their trial.

Cook CE, et al. Treatment fidelity in clinical trials. Arch Physiother. 2024 Sep 16;14:65-69. (5-page paper)

• Summary: Treatment/intervention fidelity has traditionally referred to the extent to which an intervention is implemented by the clinicians (or whomever is deploying the intervention) as intended by the researchers who designed the trial. This requires careful attention to three key components: (1) Protocol adherence, (2) Quality of delivery, and (3) Participant adherence. In this viewpoint, the authors describe several cases in which fidelity was lacking and give suggestions for how to improve. Lastly, it is argued that intervention fidelity should be considered an essential element of a trial.