摘要
目的:构建一套科学、规范且融合蒙医特色的蒙医整骨手法治疗肱骨外科颈骨折(humerus surgical neck fracture,HSNF)临床试验核心指标集(core outcome sets,COS)。方法:结合文献研究、问卷调查、专家咨询和共识会议等研究方法构建COS。检索数据库并分析已发表的研究报告及临床研究方案,开展医生和患者问卷调查,提取收集HSNF疗效评价指标形成结局指标池。采用德尔菲调查法,邀请蒙医、中医、西医骨伤科医师及临床研究工作者进行指标的重要性评分,再通过共识会议确定最终的COS。结果:通过文献检索获得13333篇文献信息,经筛选最终纳入61篇文献;问卷调查共15位医生、6位SHNF患者参与,整理提取文献研究和问卷调查指标收集结果,形成包括31个指标的结局指标池。经过两轮德尔菲调查,专家对指标进行了评分,26个指标进入共识会议讨论,最终共识会议确定了11个结局指标进入核心结局指标集。覆盖疼痛(患者主诉疼痛、骨折部位压痛)、功能状态(患肢关节活动度、患肢肌肉力量、独立完成日常生活动作情况)、生活质量(生活质量评定)、影像学指标(骨折愈合时间、骨折复位优良率)、患者角度(患者治疗满意度)、安全指标(总不良反应/事件发生率)和蒙医指标(蒙医证候评价)7个指标域,并为部分指标推荐了测量方法或工具。结论:构建了一套融合蒙医特色的HSNF临床研究COS,为蒙医整骨术治疗HSNF的临床研究提供了明确的结局指标选择范围,将为蒙医临床决策和患者护理提供更具适用性的证据。未来研究应进一步验证和推广应用此COS,以推动蒙医整骨术在现代医学体系中的更广泛认可和应用。
Objective To develop a set of scientific,standardized and Mongolian medical characteristic-based core outcome 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 indicators.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 assessment),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(Mongolian 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 Mongolian 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.
作者
陈雪吟
金爱华
杨丽虹
范智荣
特日格乐
郭新峰
刘少南
Chen Xueyin;Jin Aihua;Yang Lihong;Fan Zhirong;Terigele;Guo Xinfeng;Liu Shaonan(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou Provincial Hospital of Traditional Chinese Medicine,Guangzhou510120,Guangdong,China;Inner Mongolia Autonomous Region International Mongolian Medicine Hospital,Hohhot010065,Inner Mongolia,China;Inner Mongolia Medical University,Hohhot010107,Inner Mongolia,China)
出处
《中国骨伤》
2026年第3期288-296,共9页
China Journal of Orthopaedics and Traumatology
基金
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)。
关键词
蒙医
肱骨外科颈骨折
核心指标集
中西医结合
Mongolian medicine
Humerus surgical neck fracture
Core outcome sets
Integrative medicine
