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NIH Collaboratory
Living Textbook of
Pragmatic Clinical Trials

COVID-19 Resources

Access the latest information on COVID-19 for clinical researchers
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Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures

Additional Resources

CHAPTER SECTIONS

Monitoring Intervention Fidelity and Adaptations


Section 6

Additional Resources

Expand Contributors

Leah Tuzzio, MPH
Eric Larson, MD, MPH
James Fraser

Contributing Editor
Liz Wing, MA

Journal articles
Tuzzio et al. Healthc (Amst), 2019 Pragmatic clinical trials offer unique opportunities for disseminating, implementing, and sustaining evidence-based practices into clinical care: Proceedings of a workshop
Weinfurt et al. BMC Med Res Method, 2017 Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory
Websites
RE-AIM From the website description: The goal of RE-AIM is to encourage program planners, evaluators, readers of journal articles, funders, and policy-makers to pay more attention to essential program elements including external validity that can improve the sustainable adoption and implementation of effective, generalizable, evidence-based interventions.
Dissemination and Implementation Models in Health Research and Practice From the website description: Adapt: D&I researchers often utilize theory-based approaches that evolve over time based on empirical testing. As you “shop” for an appropriate model, you should review the core concepts, proposed relationships, and outcomes to be sure you are fully informed beyond what is depicted on the graphic. It is helpful to gather associated literature to define concepts and identify any issues or recommended adaptations based on prior studies. There is likely no comprehensive model that will perfectly fit every study, so it may be necessary to either adapt a model and/or to combine multiple models for your study.
Online presentations
Videocast of NIH Workshop on D&I This is a full-day videocast workshop hosted by the NIH on the topic Pragmatic Clinical Trials–Unique Opportunities for Disseminating, Implementing, and Sustaining Evidence-Based Practices into Clinical Care (May 2017).
RE-AIM Introduction Video This is a 10-minute YouTube video where an originator of RE-AIM, Dr. Russell Glasgow, describes the framework (March 2019).
Using RE-AIM Beginning With the End in Mind: Using RE-AIM to Guide Program Planning, Implementation, and Evaluation. This is a webinar conducted by Dr. Laura Balis, University of Wyoming Extension (February 2019).
Grand Rounds webinars
November 8, 2019 Lumbar Imaging with Reporting of Epidemiology: Initial Results and Some Lessons Learned (Jeffrey Jarvik, MD, MPH, Patrick Heagerty, PhD)
April 19, 2019 Trauma Survivors Outcomes & Support (TSOS) Pragmatic Trial: Revisiting Effectiveness & Implementation Aims (Doug Zatzick, MD)
February 23, 2024 Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. Lindsell, PhD)

Previous Section


SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Anticipating Changes That May Affect Intervention Fidelity
  3. Identifying the Functions and Forms of an Intervention
  4. Frameworks for Characterizing Fidelity and Adaptations
  5. Intervention Adaptation Strategies and Examples
  6. Additional Resources


Version History

June 3, 2025: Added Grand Round (changes made by K. Staman).

Published March 2020

current section :

Additional Resources

  1. Introduction
  2. Anticipating Changes That May Affect Intervention Fidelity
  3. Identifying the Functions and Forms of an Intervention
  4. Frameworks for Characterizing Fidelity and Adaptations
  5. Intervention Adaptation Strategies and Examples
  6. Additional Resources

Citation:

Tuzzio L, Larson E, Fraser J. Monitoring Intervention Fidelity and Adaptations: Additional Resources. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/conduct/monitoring-intervention-fidelity-and-adaptations/additional-resources/. Updated December 3, 2025. DOI: 10.28929/129.

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