{"doi":"10.1093/pm/pnae067","title":"Pragmatic clinical trials as hybrid effectiveness-implementation studies to shrink the evidence-to-practice gap for chronic pain management","abstract":"To address the 17-year gap in translation of evidence to real-world clinical practice,1 clinical scientists must leverage opportunities to gather data that will accelerate implementation and dissemination of clinical practices. The clinical research pathway, from efficacy to dissemination, has opportunities for gathering data relevant to implementation. Unfortunately, perceived norms in the application of different types of study designs may inadvertently restrict opportunities to gather data that could inform these efforts. Pragmatic clinical trials (PCTs) are optimal for integrating implementation science methods. They aim to evaluate the real-world effectiveness of evidence-based clinical practices and generate findings to inform implementation and dissemination and/or policy.2 Despite this aim, it is not required that study teams clearly articulate or apply implementation science methods as part of PCTs. For example, there is wide variation in identification of and use of implementation science methods across the 11 original PCTs within the Pain Management Collaboratory (PMC).3 Although these PCTs were required to evaluate multidisciplinary nonpharmacological pain management practices in real-world clinical settings, they were not required to identify or apply implementation science methods a priori, such as understanding or identifying key implementation determinants or potential strategies that support the use of interventions being tested. To accelerate the translation of research findings to clinical practice for those living with chronic pain, we believe PCTs should be identified, constructed, and executed as hybrid effectiveness-implementation studies (herein referred to as hybrid studies) whenever possible.4 This commentary describes the rationale for this approach. Hybrid studies were formally identified in 2012 and were recently updated to align with advancements in implementation science.4 They balance evaluating clinical practice effectiveness with implementation effectiveness, which guides development of aims and outcome measures based on their relative importance in each trial. Hybrid type 1 studies primarily evaluate the effect of a clinical practice on various outcomes and secondarily identify implementation determinants or develop preliminary implementation strategies. Hybrid type 2 studies balance evaluating clinical practice and implementation effectiveness and typically have co-primary aims. Hybrid type 3 studies evaluate the effect of the implementation strategy or strategies on adoption and reach of the clinical practice, with a secondary focus on clinical practice effectiveness. The Implementation Science Work Group in the PMC, which includes all authors as members (KS, DB, MR, SM) or lead (AM), determined that all of the PCTs fit one of the hybrid study types even though researchers typically did not explicitly identify them as such. All 11 PCTs align best with hybrid type 1 or 2 studies, but none of them aligned with a hybrid type 3 study. It would be rare that a PCT would qualify as a type 3, given their primary focus on comparing implementation strategies. We do not want to exclude this possibility though, as many nonpharmacological team-based approaches (e.g., Whole Health) could rely on combinations of implementation strategies that could be evaluated in a PCT. To illustrate the fit of PMC PCTs with hybrid studies, we describe 2 PCTs. The Burgess et al. (2020) trial is a hybrid type 1 study, although it was not identified as one in the protocol paper.5 Data from the formative evaluation shaped numerous aspects of the intervention, including informing how best to implement the intervention via telehealth. Similarly, the Seal et al. (2020) trial is a hybrid type 2 study, but the protocol paper did not designate it as one.6 However, it compares different treatment approaches to engage Veterans in pain care and uses a pre-trial formative evaluation guided by the integrated Promoting Action on Resear","journal":"Pain Medicine","year":2024,"id":483806,"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":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9507,"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":360895,"name":"Karen H. Seal","orcid":"0000-0002-6676-9117","position":1,"is_corresponding":false},{"id":536560,"name":"Diana J. Burgess","orcid":"0000-0003-1139-7739","position":2,"is_corresponding":false},{"id":386771,"name":"Marc I. Rosen","orcid":null,"position":3,"is_corresponding":false},{"id":360890,"name":"Steve Martino","orcid":"0000-0002-7308-6592","position":4,"is_corresponding":false},{"id":794496,"name":"Amanda M. Midboe","orcid":null,"position":0,"is_corresponding":true}],"reference_count":11,"raw_metadata":null,"created_at":"2026-07-19T02:07:33.718973Z","pmid":"39514879","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":[]}