Real-world evidence studies using health insurance claims data are utilized in clinical research. This review provides operational definitions of the study population, intervention/exposure, comparison, and outcomes (PICO) in integrative medicine research (conventional and Korean medicine approaches), with case-based examples. Illustrative claims-based studies using Korean national health insurance data were selected, and how PICO elements had been operationally defined in the research were reviewed. Key variables were categorized into general information, diagnosis information, and medical service information, and mapped to Health Insurance Review and Assessment Service-National Patient Sample and National Health Insurance Service-National Sample Cohort tables to describe their roles in constructing each PICO component. Population was primarily defined using diagnosis information, with variations depending on the breadth of diagnosis code inclusion, while medical service utilization information enabled more refined patient selection. Intervention was mainly operationalized using treatment and prescription codes, service types, and treatment intensity. Comparison groups were constructed by confirming no exposure and improving clinical comparability using confounding-control strategies. Outcomes were defined using combinations of diagnosis records, healthcare utilization events, and mortality data. This review provides a practical framework for operationally defining PICO elements in claims-based real-world evidence studies and may improve rigor and reproducibility in future research.
Clinical practice guidelines (CPGs) published in Korea were reviewed to evaluate up-to-date evidence and the recommendations for cupping therapy (CT) to inform clinicians and researchers for future studies. There were 14 CPGs (allergic rhinitis, ankle sprain, cervical pain, chronic low back pain, cold hands and feet, facial nerve palsy, Hwabyung, knee osteoarthritis, lumbar herniated intervertebral disk, migraine, osteoporosis, postoperative syndrome, shoulder pain, and traffic accident injury) with 29 recommendations for CT determined from “low” to “moderate” rated evidence. The levels of evidence were mostly downgraded due to the risk of bias and imprecision. The majority of recommendations for CT were graded as B or C. This comprehensive analysis underscores the imperative need for robust clinical research, including randomized controlled trials and observational studies using real-world data to enhance the quality of the evidence for CT. In addition, recommendations providing definite phases or scope of the target conditions/diseases and treatment regimens should be employed. This work lays a foundational step towards integrating CT into evidence-based clinical practice, emphasizing strategic directions for future research to bridge the gap between evidence and practice.
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