中医患者报告结局量表研究现状文献计量学分析

Bibliometric Analysis on Research Status of TCM Patient-reported Outcome Scale

目的分析目前中医患者报告结局(PRO)量表的研究现状及存在的问题,为中医PRO量表研制提供参考。方法在中国知识资源总库(CNKI)、中国学术期刊数据库(万方数据)、中国生物医学文献数据库(CBM)、PubMed、Embase及Web of Science中检索中医PRO量表研究文献,收集量表相关信息,抽取量表相关的12个数据元素进行统计,分析中医PRO量表的开发情况及测评情况等。结果共纳入88篇文献,涉及50个量表。研究集中在2008-2022年,涉及疾病种类以消化系统最多;中医PRO量表设置以3~4个维度最多,其中有9个量表设置了中医特色维度;条目池的构建多采用专家咨询法、文献研究法及访谈法相结合;条目筛选方面,运用客观方法的较多,其次为主观德尔菲法及主客观方法结合;量表测评方面,27个量表进行了信度测评,24个量表进行了效度测评,9个量表进行了反应度测评,16个量表进行了可行性测评。结论中医PRO量表的研究整体处于起步阶段,其研制的规范度及完整度仍存在不足,信效度等指标测评需引起重视,维度和条目设置方面需注重结合中医自身治疗特色,后续学者需更加完善中医PRO量表研制过程,丰富中医临床诊疗评价体系。

Objective To analyze the current research status and existing problems of TCM patient-reported outcome(PRO)scale;To provide reference for the development of TCM PRO scale.Methods Related literature of TCM PRO scale was retrieved from CNKI,Wanfang Data,CBM,PubMed,Embase and Web of Science,and relevant information of TCM PRO scale was collected.12 data elements related to the scale were extracted for statistics,and the development and evaluation of the TCM PRO scale were analyzed.Results A total of 88 articles were included,involving 50 scales.The results showed that the research on TCM PRO scale was concentrated from 2008 to 2022.Digestive system related PRO scale accounted for the largest number of diseases involved.In terms of dimension setting,3-4 dimensions were the most common,among which 9 scales were set with unique TCM characteristics.The construction of item pool mainly adopted the combination of expert consultation,literature research and interview.The selection of items mainly used objective methods,followed by the subjective Delphi method and the combination of subjective and objective methods.In terms of scale evaluation,27 scales were tested for reliability,24 scales were tested for validity,9 scales were tested for responsiveness,and 16 scales were tested for feasibility.Conclusion The research of TCM PRO scale is in the initial stage.There are deficiencies in the normalization degree and evaluation of its development.The evaluation of reliability and validity and other indicators should be paid attention to.In terms of dimension and item setting,attention should be paid to combining the treatment characteristics of TCM.Subsequent scholars need to further improve the development process of the TCM PRO scale and enrich the clinical diagnosis and treatment evaluation system of TCM.