特发性肺间质纤维化患者健康相关中医生活质量评价量表IPF-TCM-HRQOL32的设计与信效初评

Establishment and evaluation of IPF-TCM-HRQOL32: A health-related quality of life of TCM scale for patients with idiopathic pulmonary fibrosis

目的:制定健康相关中医生活质量评价量表,即IPF-TCM-HRQOL32(简称IPF-TQ32)。方法:本研究基于结构化决策法、文献研究法、统计分析方法,运用Delphi专家预测法(主观法)及临床测评法(客观法)对包含有67条目的条目池进行反复筛选,并对筛选后量表进行初步的信度和效度评价。结果:IPF-TQ32包含条目32个,反映了特发性肺间质纤维化患者中西医症状(证候)、生理功能、心理状态、社会适应4个维度。在主观筛选中,3轮筛选的专家积极系数均100%;专家权威系数平均值0.86;3轮专家意见的协调程度系数分别为0.292、0.435和0.566,共删除条目26个。基于50例临床患者的客观筛选中删除条目9个。信度和效度初评中,量表总体分半信度系数为0.977;量表总体克朗巴赫信度α系数为0.987;本量表与CAT呼吸问卷相比标准效度系数为-0.820(P<0.01)。结论:IPF-TQ32经初评证明其信度、效度均较好,在进一步大规模验证后可作为一种可靠的测评工具。

Objective： This study aimed at inheriting the advantages of traditional Chinese medicine, and would make up the defect of treatment evaluation, reference the methods of scale establishment, take in the TCM merits, and then set up a health-related quality evaluation scale IPF-TCM-HRQOL32（IPF-TQ32） which contains characteristics of traditional Chinese medicine and would be suitable for the Chinese humanistic background. Methods： Based on the structured decision, literature query, statistical analysis, 67 items were checked by the rule of Delphi expert consultation and clinical test, then the reliability and validity of the scale were tested. Results： The IPF-TQ32 contains 32 items. It could reflect four dimensions which were symptoms of integration of TCM and western medicine, physiological function, mental function and social adaptability. The three rounds of Delphi expert consultation evaluation showed that the expert positive coefficient were 100%, the average of the maximum expert authority was 0.86, and the three rounds of expert opinion coordination degree coefficient was 0.292, 0.435 and 0.566 respectively, therefore 26 items were weeded out in this test. In the clinical test which contained 50 patients, 9 items were dislodged. With further study, it showed that the half reliability coefficient of the scale was 0.977, the crowns Bach reliability coefficient was 0.987. Compared with the CAT respiratory questionnaire, the standard validity coefficient of the scale was-0.820（P〈0.01）. Conclusion： The reliability and validity of the scale IPF-TQ32 were favorable. It could be used as a quality of scale of IPF independently, also as a tool to evaluate the life quality in clinical.