不孕症中医患者结局报告量表的研制与考评

Development and evaluation of patient reported outcomes scale of traditional Chinese medicine for infertile patients

目的:按照国际通用的方法研制切实反映中医疗效、具有中医特色的不孕症患者结局报告(PRO)量表,并进行初步考评。方法:遵循PRO量表的制作指南,构建量表理论框架,形成量表初稿,进行临床调查,采用Cronbach’sα系数、因子分析法、条目分布考察法等5种统计学方法进行条目筛选,形成终量表,对终量表进行信度和效度考评。结果:终量表含33个条目,4个维度(生理、心理、社会、治疗),终量表的Cronbach’sα系数为0.886,折半信度系数为0.766,内容效度、结构效度经检验结构设置相关程度良好。结论:本研究构建的不孕症中医PRO量表具有科学性、有效性、实用性,经检验该量表信度、效度良好,可在临床推广应用。

Objective: To develop and preliminarily evaluate the patient reported outcome(PRO) scale for infertility patients with TCM characteristics according to the international methods. Methods: Following the PRO scale production guidelines,the theoretical framework of the scale was constructed, the preliminary draft of the scale was formed, and clinical investigation was conducted. Five statistical methods, including Cronbach’s α, coefficient factor analysis and item distribution investigation, and so on were used to select items and form the final scale. The final scale reliability and validity was evaluiated. Results: The final scale contained 33 items and 4 dimensions(physiological, psychological, social, and therapeutic). The Cronbach’s α and SpearmanBrown of the final scale were 0.886 and 0.766. The correlation degree of content validity and structure validity was good after testing the structure setting. Conclusion: This research constructs a scientific, effective, and practical Chinese medicine PRO scale of infertility, the reliability and validity of the scale is good, can be popularized in clinical application.