Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory
Year: 2024
Type: article
Abstract: OBJECTIVE: Most pragmatic trials follow the PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) criteria. The criteria specify unobtrusive measurement of participants' protocol adherence and practitioners' intervention fidelity but suggest no special monitoring strategies to assure trial integrity. We present experience with adherence/fidelity monitoring in the Pain Management Collaboratory (PMC) and provide recommendations for their monitoring in pragmatic trials to preserve inferences of treatment comparisons. METHODS: In November 2021, we surveyed 10 of 11 originally funded PMC pragmatic trials to determine the extent to which adherence and fidelity data were being monitored. RESULTS: Of the 10 PMC trials, 8 track adherence/fidelity. The electronic health record is the most frequent source for monitoring adherence (7/10) and fidelity (5/10). Most adherence data are used to monitor participant engagement with the trial intervention (4/10) and are reviewed by study teams (8/10) and often with a data and safety monitoring board (DSMB) (5/10). Half of the trials (5/10) reported using fidelity data for feedback/training; such data are not shared with a DSMB (0/10). Only 2 of 10 trials reported having prespecified guidance or rules around adherence/fidelity (eg, stopping rules or thresholds for corrective action, such as retraining). CONCLUSIONS: 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.
Source: Pain Medicine
DOI: 10.1093/pm/pnae080
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: bronze
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 Advancing Translational Sciences, National Center for Complementary and Integrative Health
Awards: G1044130170, G2137568036, G2233518721, G30427485, G3101559137, G348017501, Engaging Veterans Seeking Service-Connection Payments in Pain Treatment, G4404991022, Chiropractic Care for Veterans: A Pragmatic Randomized Trial Addressing Dose Effects for cLBP, Improving Veteran Access To Integrated Management of Chronic Back Pain, G6050932541, G9000040303, G9000175628, G9000215110, G9000218541, G9000260968, Yale Clinical and Translational Science Award
OpenAlex ID: W4404173180