肌肉骨骼疼痛共性核心集与中医外治特色集双维结局指标集的构建OA
Construction of a Dual-dimensional Outcome System for Musculoskeletal Pain:A Common Core Outcome Set and A Specific Outcome Set for Traditional Chinese Medicine External Treatment
目的 构建肌肉骨骼疼痛共性核心集(MKP-COS)与肌肉骨骼疼痛中医外治特色集(MKP-SOS-ETCM),为肌肉骨骼疼痛相关临床研究提供依据,也为相关领域核心结局指标集的构建提供参考.方法 检索现有肌肉骨骼疼痛(MKP)核心结局指标集(COS)文献,提取核心结局指标作为条目池,通过德尔菲法邀请专家就肌肉骨骼疼痛共性结局指标和中医外治干预特色结局指标达成共识,共识纳入标准设定为重要性评分7~9分专家数≥75%.结果 纳入47项COS研究,经讨论整理后初步条目池包含34个结局指标,经过3轮德尔菲专家共识,得出肌肉骨骼疼痛共性核心结局集包括疼痛、运动功能、关节活动度、日常生活活动能力、不良事件/不良反应5个结局指标;中医外治特色结局集包括僵硬(包括晨僵)、关节压痛计数、工作状态/生产力、医生整体评估、结构损伤、肌肉力量6个结局指标.结论 构建了肌肉骨骼疼痛共性核心结局集及肌肉骨骼疼痛中医外治特色结局集,形成了疾病共性+干预特色的双维度评估体系.
Objective To develop a core outcome set for musculoskeletal pain(MKP-COS)and a specific out-come set for traditional Chinese medicine external treatment(MKP-SOS-ETCM),providing a standardized basis for clinical research in musculoskeletal pain and serving as a reference for core outcome set(COS)development in related fields.Methods Existing COS studies on musculoskeletal pain(MKP)were systematically searched,and core out-come indicators were extracted to form an initial item pool.The Delphi method was used,in which experts were invited to reach consensus on MKP-COS and MKP-SOS-ETCM.The inclusion criteria for consensus are set as an importance score of 7-9 points with ≥75%of experts reaching agreement.Results A total of 47 COS studies were included,and after discussion and consolidation,a preliminary item pool containing 34 outcome indicators was established.After three rounds of Delphi expert consensus,MKP-COS was identified,including five outcomes including pain,motor function,joint range of motion,activities of daily living,and adverse events/adverse reactions;MKP-SOS-ETCM included six outcomes involving stiffness(including morning stiffness),joint tenderness count,work status/productivity,overall physician assessment,structural damage,and muscle strength.Conclusion This study has established MKP-COS and MKP-SOS-ETCM,forming a dual-dimensional outcome assessment system integrating both disease commonality and intervention specificity.
梁元文;陈红;孙亚男;于长禾
北京中医药大学第一临床医学院,北京市东城区海运仓5号,100700北京中医药大学东直门医院首都医科大学宣武医院北京中医药大学东直门医院
肌肉骨骼疼痛核心结局指标集特色结局集德尔菲法中医外治
musculoskeletal paincore outcome setspecific outcome setDelphi methodtraditional Chinese medicine external treatment
《中医杂志》 2026 (14)
1503-1508,6
中央高校基本科研业务费专项资金(2025-JYB-JBGS-015)国家自然科学基金(82374617,81803956)2024年北京中医药大学"双一流"学科建设项目
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