Application of Patient-Reported Outcome Measurements in Traditional Chinese Medicine Clinical Trials for Musculoskeletal Disorders in China: A Registry-Based Analysis

Abstract

This study aimed to analyse the application characteristics of patient-reported outcomes (PROs) in traditional Chinese medicine (TCM) clinical trials for musculoskeletal disorders in China. This study included TCM clinical trials for musculoskeletal diseases conducted in China between January 1, 2010, and August 1, 2023. Data were extracted from ClinicalTrials.gov, the Chinese Clinical Registry, and the International Traditional Medicine Clinical Trial Registry. Eligible trials were categorized as (1) explicitly specified PROs, (2) implicitly specified PROs (generic outcome concepts [e.g., pain] without naming a specific instrument), and (3) PROs not mentioned. Of 494 eligible trials, 446 (90.3%) used PROs as endpoints. Of 67,839 participants, 58,093 (85.6%) were in trials with specific PRO tools, 4,400 (6.5%) in trials with ambiguous PRO descriptions, and 5,346 (7.9%) in trials without PROs. Arthropathies (43.0%) were the most common condition among PRO-inclusive trials, and the Visual Analogue Scale was the most frequently used PRO tool. Primary sponsors showed significant regional imbalance, with most concentrated in eastern China. This study demonstrated a significant emphasis on PRO application in TCM clinical trials for musculoskeletal diseases in China, while also identifying gaps in standardization and regional distribution that require addressing.

Keywords

patient-reported outcome measures medicine Chinese traditional musculoskeletal diseases registries

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