基于中医基础理论的痛经生命质量量表的研制与条目筛选

Development of a dysmenorrhea quality of life scale based on Traditional Chinese Medicine theory

目的研制基于中医基础理论的痛经生命质量量表,筛选、优化条目,探索中医药临床产出评价的参考工具。方法通过文献研究与知情人访谈,构建量表的理论结构模型,进行条目整理,形成包括41个条目的条目池;采用德尔菲法对条目初筛与调整后形成初量表;采用调查统计方法,对纳入的200例受访者数据,采用频数分布法、离散趋势法、因子分析法、相关系数法、Cronbach’s α系数法5种统计学方法对条目池进行筛选。结果2轮问卷调查后得到30个条目,专家积极系数分别为100%和83.3%,积极程度较高;专家权威系数均>0.7,研究结果权威性与可靠性较高;Kendall协调系数W为0.333(χ^(2)=128.271,P<0.001),协调程度尚可。经上述5种统计学方法分析后,删除≥2种统计结果不符合要求的条目,量表最终保留20个条目,涵盖8个维度。结论本研究符合中医理论及量表研制流程规范,专家代表性强,权威程度高,积极性高,统计筛选方法选择合理,量表具有较强的可操作性及适用性,可成为探索中医药临床产出评价的参考工具。

Objective Dysmenorrhea is the common gynecological problem among adolescent girls and women of reproductive age.This study aim to develop a dysmenorrhea Quality of Life(QoL)scale based on Traditional Chinese Medicine(TCM)theory.Methods We conducted focus group discussions and in-depth interviews with TCM gynecologists and patients,and adapted items from previously published scales.We generated an initial pool of 41 items with 8 domains.Delphi method was used to item preliminary selection.Then,we administered the items to a sample of adolescent girls(n=200),and the distribution of survey items,discrete trend,factor analysis,correlation coefficient,Cronbach’s α coefficient were used to select items.Results After two rounds of Delphi,a total of thirty items were included in the dysmenorrhea QoL scale.The expert positive coefficient were 100%and 83.3%with high motivation.The authoritative coefficient were greater than 0.7,the results showing authoritative and reliable.The Kendall’s coefficient of concordance W was 0.333(χ^(2)=128.271,P<0.001).In sample analysis,the items were deleted when they met more than two standards.The final scale retained 20 items,covering 8 dimensions.Conclusions The methods for selection of dysmenorrhea QoL scale based on TCM theory were preferable.Given the paucity of research in this area,this new dysmenorrhea QoL scale may provide opportunities for the patient-reported outcome(PRO)evaluation in the field of TCM.