Secondary analyses of Traditional East Asian Medicine (TEAM) case report and clinical registry data on pain: A study protocol

• Clinical training or development in Traditional East Asian Medicine rely on case reports. • Methods for secondary analyses of case reports are underdeveloped. • New models for analysis of clinical registry data and case reports are important. • Qualitative and quantitative methods to analyse pragmatic data. • Increased rigor validity and applicability from practice-based research. Traditional East Asian Medicine (TEAM) relies heavily on case reports for clinical decision-making. However, methods for analyzing data from multiple case reports are currently underdeveloped. This protocol will outline novel methods for secondary analyses of TEAM case reports and clinical registry data focused on pain to inform practice-based research. We will use a concurrent triangulation mixed methods design to analyze data from 12 case reports and 130 clinical registry records, meeting the requirements of the CARE guidelines and focusing on TEAM treatments for pain. Quantitative analysis will include descriptive statistics, pairwise t -tests, and responder analysis. Qualitative analysis will employ thematic analysis with both deductive and inductive approaches. Data will be standardized using ICPC-2 and ICD-11 Traditional Medicine codes. Key focus areas include practitioner diagnosis, clinical reasoning, patient outcomes, and self-care behaviors. Anticipated outcomes include refined methodologies for case report and clinical registry data analysis, insights into TEAM clinical practice patterns, and identification of complex system phenomena within TEAM frameworks. This project aims to address research gaps in modelling case data analysis methodologies for TEAM, potentially enhancing the rigor, validity, and applicability of practice-based research, informing clinical trial design, and contributing to better patient-centered care.