Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory
As a best practice for pragmatic trials, we recommend early and regular adherence/fidelity monitoring to determine whether intervention delivery is as intended. We propose a 2-stage process with thresholds for intervening and triggers for conducting a formal futility analysis if adherence and fidelity are not maintained. The level of monitoring should be unobtrusive for both participants and those delivering the intervention; resulting data should be reviewed by an independent DSMB.
Authors
- Mary Geda (ORCID: https://orcid.org/0000-0002-9129-4432)
- Scott Coggeshall
- Kathryn Gilstad‐Hayden
- Peter Peduzzi (ORCID: https://orcid.org/0000-0002-7634-6804)
- Tassos C. Kyriakides (ORCID: https://orcid.org/0000-0001-8913-108X)
- Eugenia Buta (ORCID: https://orcid.org/0000-0001-8478-4233)
- James D Dziura (ORCID: https://orcid.org/0000-0001-8953-6183)
- Qilu Yu (ORCID: https://orcid.org/0000-0003-2641-3535)
- Cynthia R. Long (ORCID: https://orcid.org/0000-0002-1980-1620)
- Cynthia J. Coffman (ORCID: https://orcid.org/0000-0002-4554-1463)
Institutions
- Palmer College of Chiropractic (US)
- Duke University (US)
- Yale University (US)
- National Center for Complementary and Integrative Health (US)
- The Coordinating Center (US)
- VA Puget Sound Health Care System (US)
- Yale New Haven Health System (US)
- Durham VA Health Care System (US)
- Program Support Center (US)
Publication Details
- Journal
- Pain Medicine
- Published
- 2024-11-01
- DOI
- https://doi.org/10.1093/pm/pnae080
- Citations
- 2
- Primary Topic
- Musculoskeletal pain and rehabilitation
- Type
- article
- Field-Weighted Citation Impact
- 0.90
Funders
- U.S. Department of Veterans Affairs
- Health Services Research and Development
- National Institutes of Health
- Uniformed Services University of the Health Sciences
- Office of Behavioral and Social Sciences Research
- National Center for Complementary and Integrative Health