特发性肺间质纤维化患者生活质量评价量表研制

Research on Life Quality Scale for Patients with Idiopathic Pulmonary Fibrosis

目的研制适合特发性肺间质纤维化(idiopathic pulmonary fibrosis,IPF)生活质量评价量表,客观反映疾病变化。方法根据患者报告临床结局(patient-reported outcome,PRO)量表制定原则,结合中医基础理论,提出量表的理论结构模型,广泛查阅国内外多种呼吸系统疾病生活质量量表,采用结构化决策的方法,编制初始量表。用调查方式对34例确诊IPF患者进行测试,运用专家重要性评分法、因子分析法、相关系数法、克朗巴赫α系数法联合进行条目筛选最终确定IPF生活量表(IPF patient reported outcomes IPF PRO,IP)。结果研制出含有3个领域、38项条目的 IP量表。SGPQ和IP量表临床症状分值相关性分析Pearson相关系数为0.828(P<0.01);活动能力分值相关性分析Pearson相关系数为0.929(P<0.01);疾病对日常生活影响分值相关性分析Pearson相关系数为0.903(P<0.01);总分值相关性分析Pearson相关系数为0.862(P<0.01)。对IP量表本身进行信度(reliability)分析,克朗巴赫系数为0.713,用因子分析法对所得数据分析,KMO统计量为0.902。结论 IP量表全面反映了IPF患者生活质量的内涵,可作为IPF患者中医临床疗效评价的工具。

Objective To develop a life quality scale suitable for idiopathic pulmonary fibrosis（ IPF） patients,objectively reflecting its changes. Methods Authors first put forward a theoretical structure model of a scale according to patient-reported outcome（ PRO） scale formulation principle by combining basic theories of Chinese medicine（ CM）. Then authors developed an initial scale on the basis of various life quality scales for respiratory disease patients by using structural decision making. Totally 34 patients with confirmed diagnosis of IPF were tested by questionnaire. Items were screened using expert importance scoring method,factor analysis,correlation coefficient method,Cronbach＇s alpha coefficient method. IPF patient reported outcomes（ IPF PRO,IP） were finally defined. Results A new IP scale was developed covering three areas and 38 items. Pearson correlation coefficient for correlation analysis of clinical symptom scores in ST-George Respiratory Questionnaire and IP scale was 0. 828（ P 〈0. 01）. Pearson correlation coefficient for correlation analysis of activity ability scores was 0. 929（ P 〈0. 01）. Pearson correlation coefficient for correlation analysis of total scores was 0. 862（ P 〈0. 01）.By reliability of IP scale itself（ reliability） analysis,Cronbach＇s alpha coefficient was 0. 713. By using factor analysis method for data analysis,KMO statistics was 0. 902. Conclusion IP scale fully reflected the connotation of IPF patients＇ quality of life,so it could be used as CM clinical therapeutic effect evaluation tool.