中国骨伤2026，Vol.39Issue(3)：288-296,9.DOI:10.12200/j.issn.1003-0034.20240842
蒙医整骨手法治疗肱骨外科颈骨折临床试验的核心指标集构建与思考
Construction and reflection of the core outcome set for clinical trials of Mongolian orthopedic manipulation therapy for humerus surgical neck fracture
摘要
Abstract
Objective To develop a set of scientific,standardized and Mongolian medical characteristic-based core out-come sets(COS)for the clinical trial of Mongolian osteopathic manipulation in the treatment of humerus surgical neck fractures(HSNF).Methods This study constructed COS by combining literature research,questionnaire surveys,expert consultations and consensus conferences.Firstly,it retrieved the databases and analyzed the published research reports and clinical research protocols,conducted questionnaires for doctors and patients,extracted and collected the efficacy evaluation indicators of HSNF to form the outcome indicator pool.Then,it used Delphi survey method to invite Mongolian medicine,traditional Chinese medicine,and Western medicine orthopedic physicians as well as clinical research workers to rate the importance of the indi-cators.Finally,a consensus conference was held to determine the final COS.Results Through literature search,13,333 pieces of information were obtained.After screening,61 pieces of literature were finally included.A total of 21 doctors and patients participated in the questionnaire survey.The results of the research in the literature and the questionnaire survey indicators were sorted and extracted,forming an outcome indicator pool consisting of 31 indicators.After two rounds of Delphi surveys,experts rated the indicators,and 26 indicators were included in the consensus meeting for discussion.Finally,the consensus meeting determined that 11 outcome indicators entered the core outcome indicator set.Seven indicator domains were covered:pain(patients' self-reported pain,tenderness at the fracture site),functional status(joint range of motion of the affected limb,muscle strength of the affected limb,ability to independently complete daily activities),quality of life(quality of life assess-ment),imaging indicators(fracture healing time,excellent rate of fracture reduction),patient perspective(patient treatment satisfaction),safety indicators(total incidence rate of adverse reactions/events),and Mongolian medicine indicators(Mongo-lian medicine syndrome evaluation).Measurement methods or tools were recommended for some indicators.Conclusion A clinical research COS integrating the characteristics of Mongolian medicine was established,providing a clear range of outcome indicators for the clinical research of Mongolian osteopathy in treating HSNF.This will offer more applicable evidence for Mon-golian clinical decision-making and patient care.Future studies should further validate and promote the application of this COS to facilitate the wider recognition and application of Mongolian osteopathy in the modern medical system.关键词
蒙医/肱骨外科颈骨折/核心指标集/中西医结合Key words
Mongolian medicine/Humerus surgical neck fracture/Core outcome sets/Integrative medicine分类
医药卫生引用本文复制引用
陈雪吟,金爱华,杨丽虹,范智荣,特日格乐,郭新峰,刘少南..蒙医整骨手法治疗肱骨外科颈骨折临床试验的核心指标集构建与思考[J].中国骨伤,2026,39(3):288-296,9.基金项目
少数民族医药疗效评价方法研究及循证支持系统构建(编号:2022YFC3501001)Research on the Methods of Effectiveness Assessment for Ethnic Minority Medicine and Establishment of Evidence-Based Sup-port System(No.2022YFC3501001) （编号:2022YFC3501001）
