摘要
Objective To develop a quality appraisal tool for case reports in traditional Chinese medicine(TCM)based on their characteristics.Methods An extensive literature search was conducted in Chinese Biomedical Literature Database(CBM),China National Knowledge Infrastructure(CNKI),and China Science and Technology Journal Database(CSTJ),focusing on expert consensus statements and check-lists for TCM case reports.Relevant items were extracted,and a Delphi method involving 34 experts was used in two rounds to rate each item on a 5-point Likert scale.Items were screened based on measures of central tendency and coordination(including total score,mean score,percentage of items rated as unimportant,and coefficient of variation).The weighted average method was used to determine item weights and construct the appraisal tool.Internal consistency was assessed using Cronbach’sαcoefficient.The finalized tool was pilot-tested by two reviewers independently appraising 20 case reports,with an additional four reviewers evaluating 5 of these cases to compare inter-rater consistency.Results A total of 9513 articles were retrieved,and 96 items from 25 articles were extracted.After two rounds of the Delphi method,27 items across 10 domains were retained.The Cron-bach’sαcoefficient was 0.72 in the first round(acceptable range),and 0.96 in the second round,indicating strong internal consistency.The tool was piloted by six reviewers,achieving a kappa value of 0.663 and a Kendall’s coefficient of concordance of 0.845,demonstrating high consistency among reviewers.Conclusion The developed TCM case report quality appraisal tool,consisting of 27 items in 10 domains,offers a scientific and reliable means of assessing the quality of TCM case reports.The tool showed high consistency and practical utility,and its application is expected to en-hance the standardization,scientific rigor,and evidence quality of TCM case reports,facilitat-ing the integration of traditional medical knowledge with modern evidence-based standards.
目的 基于中医病例报告特点开发一种中医病例报告的质量评估工具。方法 研究首先系统检索了中国生物医学文献数据库(CBM)、中国知网(CNKI)以及中国科技期刊数据库(CSTJ)中有关中医病例报告专家共识及相关清单的文献,筛选并提取了相关条目。在此基础上,邀请34位专家采用德尔菲法进行了两轮咨询,专家根据条目重要性采用李克特五级量表评分,并依据集中度与协调度(包括总分、均分、不重要率和变异系数)筛选条目。采用加权平均法确定各条目权重,形成质量评价工具。工具的内部一致性通过克隆巴赫系数进行评价。最终工具由两位评审员独立评价20份病例报告,另有四位评审员对其中5份病例进行重复评价,以比较一致性。结果 文献检索共纳入9 513篇文献,最终提取25篇文献、96个相关条目。德尔菲法两轮问卷分析后,最终保留了10个领域、共27个条目。第一轮克隆巴赫系数为0.72,处于可接受范围;第二轮系数为0.96,表明具有高度一致性。工具经六位评审员试用,kappa值为0.663,Kendall协调系数为0.845,说明评分结果高度一致。结论 本研究制定的中医病例报告质量评价工具涵盖10个领域、27个条目,具有良好的科学性和实用性。工具的一致性验证结果良好,有望推动中医病例报告的规范化、标准化,提升学科证据质量,促进传统医学经验与现代循证医学的融合。
基金
General Program of National Natural Science Foundation of China (82274412)
Natural Science Foundation of Hunan Province (2020JJ4062)
Science and Technology Innovation Program of Hunan Province (2020RC2061)。
作者简介
Corresponding author:Zhixi HU,E-mail:003405@hnucm.edu.cn.
