{"doi":"10.1093/pm/pnae080","title":"Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory","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.","journal":"Pain Medicine","year":2024,"id":479151,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9632,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":386768,"name":"Kathryn Gilstad‐Hayden","orcid":null,"position":1,"is_corresponding":false},{"id":292212,"name":"Cynthia J. Coffman","orcid":"0000-0002-4554-1463","position":2,"is_corresponding":false},{"id":411317,"name":"Cynthia R. Long","orcid":"0000-0002-1980-1620","position":3,"is_corresponding":false},{"id":938338,"name":"Qilu Yu","orcid":"0000-0003-2641-3535","position":4,"is_corresponding":false},{"id":377018,"name":"Eugenia Buta","orcid":"0000-0001-8478-4233","position":5,"is_corresponding":false},{"id":389460,"name":"Scott Coggeshall","orcid":null,"position":6,"is_corresponding":false},{"id":536559,"name":"Mary Geda","orcid":"0000-0002-9129-4432","position":7,"is_corresponding":false},{"id":98374,"name":"Peter Peduzzi","orcid":"0000-0002-7634-6804","position":8,"is_corresponding":false},{"id":688986,"name":"Tassos C. Kyriakides","orcid":"0000-0001-8913-108X","position":9,"is_corresponding":false},{"id":230349,"name":"James Dziura","orcid":"0000-0001-8953-6183","position":0,"is_corresponding":true}],"reference_count":21,"raw_metadata":null,"created_at":"2026-07-19T02:06:50.355747Z","pmid":"39514878","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}