“基于心血管疾病病人报告的临床疗效评价量表”的研制及统计学分析

Statistical Analysis of Efficacy Evaluation Based on Questionnaire of Cardiovascular Diseases

目的编制具有普适性的基于心血管疾病病人报告的临床疗效评价量表，并对其信度和效度进行检验。方法筛选条目，优化条目，形成条目池和域体系，将条目转化成量表，小样本预调查，进一步完善量表并形成初始量表，采用多种统计方法对其信度和效度进行检验。结果初步形成一个具有3个域体系（躯体症状、社会t心理因素和满意度）、28个条目的量表。该量表总克朗巴赫系数α（Cronbach＇s lpha）为0．897。折半信度（Split-Cronbach＇s Alpha）分析，第1部分（条目1～14）和第2部分（条目15～28）折半信度分别为0．890和0．798，两部分阅的相关系数为0．536。量表KMO（Kaiser-Meyer-Olkin measure of sampling adequacy）统计量为0．809，经Bartlett检验，各变量间信息的重叠程度较高（χ^2=2200．924,P〈0．0001），适合做因子分析，表明该量表具有较高的效度。结论该量表可作为心血管疾病病人报告的临床疗效评价的初级量表。

Objective To compile questionnaire for efficacy evaluation based on patient - reported - outcomes （PRO） in patients （pts） with cardiovascular diseases and analyze the reliability and validity. Methods An item pool and：3 domain systems were determined. Then the items were transferred into questions, and some small sample pre - surveys were performed to form the original questionnaire. The reliability and validity of the questionnaire were tested with manifold statistical methods. A questionnaire with ：3 domain systems （physical symptoms, social-psychological factors and satisfaction degree） containing 28 items was established primarily. Results The total Cronbach＇s Alpha of the questionnaire was 0. 897. By Split- Cronbachs Alpha analysis, the Split - Cronbach＇s Alpha value of the part one （iteml - 14） and the part tWO （item15 - 28） were 0o 890 and 0. 798 respectively. The correlation coefficient between the two parts was 0. 536 and it suggested that the questionnaire with a high reliability. The KMO（Kaiser - Meyer - Olkin Measure of Sampling Adequacy）value was 0. 809,by Bartlett test（P〈0. 000 1, χ^2 = 2 200. 924）, indicating that it was rationable tO make factor analysis because of the high overlapness among the variables, and that the questionnaire had a high validity statistically. Concluslon The questionnaire was usable primarily for the clinical efficacy evaluation based on （PRO） in pts with cardiovascular diseases,