Best practices in methodological frameworks for evaluating procedure-based treatments in traditional, complementary...

While numerous evidence-based studies have been conducted on procedure-based treatments (PBTs) in traditional, complementary and integrative medicine (TCIM) (eg, acupuncture, special diets, lifestyle modification, yoga, Tai χ), high-quality research reports accepted by the academic community remain scarce. Key factors contributing to the low evidence quality in this field include researchers' insufficient grasp of clinical research methodology concepts, inadequate study designs and lack of pilot studies. Scholars now widely recognise that establishing a robust evaluation framework for PBTs in TCIM is crucial for progressively refining research protocols and advancing clinical practice. Therefore, this scoping review aims to systematically map current evaluation methods for PBTs in TCIM, analyse their critical procedural components and lay the groundwork for developing a tailored evaluation framework.

Forty-three databases will be systematically searched using comprehensive search strategies. Two independent reviewers will screen potential literature and select eligible studies. Literature management will be performed using NoteExpress and Excel 2016, with a pre-designed standardised Excel sheet employed for data extraction.This scoping review will include literature that provides multidimensional evaluation (eg, efficacy, safety and health economics) for PBTs in TCIM. This encompasses methodological guidelines, systematic protocols outlining evaluative structures, procedural steps and core components, as well as conceptual or theoretical frameworks describing phased evaluation processes. Screening and data extraction will be conducted independently by two researchers. Inter-rater agreement will be assessed using the Kappa statistic. Any discrepancies will be resolved through consultation with a senior reviewer or correspondence with original authors.Data extraction will capture: general information, types and number of included primary studies, interventions assessed, evaluation dimensions, procedural workflows for evaluation, version iterations of evaluation frameworks, staging configurations for evaluation, framework development methods, as well as documented strengths and limitations of the frameworks.Results will be structured following the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist. Findings will be presented through tables, charts and figures, with narrative synthesis describing key outcomes.

No private information was issued in the entire process of the systematic review. Therefore, ethical approval is not required. Findings of the scoping review will be published in a peer-reviewed journal and/or disseminated through conference presentations.

The protocol has been archived in the Open Science Framework (Registration DOI: https://doi.org/10.17605/OSF.IO/92DRM).