热敏灸治疗原发性高血压社区研究患者自我报告核心指标集的初步构建  

Development of Patient Self-Reported Core Outcome Set in Community Studies on Heat-Sensitive Moxibustion for Primary Hypertension

作　　者：游建宇 李书晴 邓桂花 周旭[2] YOU Jianyu;LI Shuqing;DENG Guihua;ZHOU Xu(School of Acupuncture,Moxibustion and Tuina,Jiangxi University of Traditional Chinese Medicine,Nanchang,330004;Evidence-based Medicine Research Centre,Jiangxi University of Traditional Chinese Medicine)

机构地区：[1]江西中医药大学针灸推拿学院,江西南昌330004 [2]江西中医药大学循证医学研究中心

出　　处：《中医杂志》2025年第1期34-41,共8页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81904057);江西省赣鄱俊才支持计划高校领军人才培养项目(QN2023045);江西中医药大学首批校级科技创新团队项目(CXTD22012)。

摘　　要：目的以原发性高血压(PH)为例构建热敏灸社区研究患者自我报告核心指标集(COS),为热敏灸社区研究疗效评价指标的选择提供参考。方法检索文献收集热敏灸治疗PH随机对照试验及系统评价中使用的结局指标(2021年1月),通过患者及专家问卷调查补充额外指标(2021年2月),构建结局指标条目池。开展多学科专家德尔菲问卷调查筛选适用于患者自我报告的重要指标(2021年4月),以Likert 5级评分法评定结局指标重要性。最后通过共识会议确定患者自我报告COS(2021年6月)。结果综合文献检索、问卷调查结果,通过规范合并结局指标生成热敏灸治疗PH社区研究患者自我报告指标条目池,共包括100项测量工具/内容,剔除51项需要依靠专业医生或者借助医院设备测量的工具/内容,最终保留49项进入初始指标条目清单。第一轮德尔菲问卷调查结果专家熟悉程度平均分为0.819,判断依据平均分为0.710,专家权威系数为0.765,共删除21项不符合标准(重要性得分≤75分或变异系数>0.25)的指标测量工具/内容,保留28项,新增了3项专家开放性补充的测量工具/内容,最终共31项纳入第二轮德尔菲问卷。第二轮德尔菲问卷调查结果专家熟悉程度平均分为0.859,判断依据平均分为0.763,专家权威系数为0.811,最终共删除11个不适合患者自我报告的指标测量工具/内容,保留了5项指标域的7个结局指标共20个指标测量工具/内容。经专家共识会议,最终确定8项结局指标纳入热敏灸治疗PH患者自我报告COS,包括疗效评价指标6项(生活质量评分、血压、中医证候积分、成本-效益、心脑血管事件、不良反应/事件)和疗效影响因素指标2项(热敏灸感、依从性评价)。结论通过构建热敏灸治疗PH社区研究患者自我报告COS,初步建立了热敏灸社区研究疗效评价指标选择标准,可为后续热敏灸社区研究的开展提供科学研究范式。Objective To establish the self-reported core outcome set(COS)for patients with an example of a community study on heat-sensitive moxibustion for primary hypertension(PH),to provide a reference for the selection of effectiveness evaluation indicators in community study on heat-sensitive moxibustion.Methods A systematic literature search was conducted to collect outcomes used in randomized controlled trials and systematic review of heatsensitive moxibustion for PH(Jan 2021),and additional outcomes were added through patient and expert questionnaires(Feb 2021)to create a pool of outcome entries.A multidisciplinary expert Delphi survey was conducted to screen outcomes applicable to patient self-reporting(Apr 2021),and the importance of outcome indicators was rated on a 5-Point Likert Scale.Finally,patient self-reported COS was determined through a consensus conference(June 2021).Results A pool of patient self-reported indicators in the community study of heat-sensitive moxibustion treatment for PH was generated by standardizing and combining the outcome indicators based on the results of the literature search and the questionnaire survey,which consisted of totally 100 measurement tools or contents,excluding 51 indicators or measurement tools required measurement by specialized physicians or hospital equipment,and 49items were retained to enter the initial list of indicator entries.For the first round of Delphi survey,the mean score for expert familiarity was 0.819,the mean score for basis of judgment was 0.710,and the expert authority coefficient was 0.765,with a total of 21 indicator measurement tools or contents deleted(significance score≤75 or coefficient of variation>0.25),28 retained,and 3 new expert-added indicator entries added.In the second round of Delphi survey,the average score for expert familiarity was 0.859,the average score for basis for judgment was 0.763,and the expert authority coefficient was 0.811,with a total of 11 indicator measurement tools or contents deleted and 20retained involving 5 doma

关 键 词：热敏灸 原发性高血压 患者自我报告 核心指标集 疗效评价 

分 类 号：R246.1[医药卫生—针灸推拿学]