Insufficient structure and reporting of process evaluations of complex interventions for musculoskeletal conditions in randomized controlled trials: a systematic review

Objectives: To explore how process evaluation of complex interventions alongside randomized clinical trials (RCTs) in musculoskeletal conditions are conducted. Study Design and Setting: Systematic review. Methods: We searched the MEDLINE, SCOPUS, CINAHL, PsycINFO, Embase, Web of Science, and Cochrane databases. Studies were included if they reported process evaluation conducted alongside RCTs, within the main report or as separate reports, that assessed process evaluation of RCTs of complex nonsurgical and nonpharmacological interventions for musculoskeletal conditions. We performed a descriptive analysis of the included studies based on process evaluation parameters. Results: Data were extracted from 61 studies from 17 countries. Our findings showed studies used qualitative, quantitative, and mixed methods for process evaluations, typically reporting within the main RCT. Most studies were conducted in primary care settings. Only a few studies (16%) included a theoretical model to guide their process evaluation. Studies reported reach (8%), patients' and clinicians' perceptions of the interventions (44% and 8%, respectively), treatment fidelity and adherence (52% and 43%, respectively), training of patients and clinicians (eg, workshops, manuals and additional training) (54%), how the integration of process evaluation and outcome evaluation findings was performed (68%), barriers to perform the process evaluation (2%), and the strengths and weaknesses of the process evaluation (65%). Conclusion: Reporting of process evaluations within RCTs is insufficiently reported. Researchers rarely adopted a theoretical model or framework to guide their process evaluation. Studies used a variety of methods to conduct process evaluations. We identified barriers, strengths, and weaknesses of methods used for assessing process evaluation as reported by authors from studies included in this review. (c) 2024 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).