Outcome reporting in randomized controlled trials of traditional Chinese medicine for primary immune thrombocytopenia: a scoping review protocol

1. Background and Rationale Primary immune thrombocytopenia (ITP) is a common autoimmune bleeding disorder frequently treated with traditional Chinese medicine (TCM). However, outcome reporting in TCM clinical trials is often heterogeneous, heavily relying on surrogate physiological endpoints while neglecting patient-reported outcomes (PROs) and TCM-specific measures. This scoping review aims to systematically map the current landscape of outcome reporting in recent RCTs of TCM for adult ITP, categorize them using the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy, and identify reporting gaps to inform the development of a Core Outcome Set (COS-TCM). 2. Eligibility Criteria (PCC Framework) • Population: Adult patients (≥ 18 years) definitively diagnosed with primary ITP. • Concept: All reported clinical outcomes, measurement instruments, and measurement timeframes. Extracted outcomes will be mapped to the 38 domains within the 4 core areas of the Dodd (COMET) taxonomy (Physiological/clinical, Life impact, Resource use, and Mortality/survival). • Context: Randomized controlled trials (RCTs) evaluating oral TCM interventions (decoctions, Chinese patent medicines) used alone or combined with conventional medicine. To reflect contemporary clinical trial design and ensure feasibility, only studies published between January 1, 2021, and the date of search will be included. 3. Search Strategy A comprehensive systematic search will be conducted in English databases (PubMed, Embase, Cochrane Library, Web of Science) and Chinese databases (CNKI, Wanfang, VIP, SinoMed). The search will combine terms related to "primary immune thrombocytopenia", "traditional Chinese medicine", and "randomized controlled trials". 4. Data Charting and Synthesis Two independent reviewers will screen records and extract data using a standardized charting form. Extracted outcomes will be verbatim recorded and mapped to the Dodd taxonomy. Descriptive statistics and evidence mapping techniques (e.g., bubble charts, tree maps) will be used to visually present the frequency, distribution, and reporting proportion of patient-important outcomes.