China is facing an increasing number of chronic disease patients. Health-related quality of life (HRQoL) is an important indicator assessing the effect of prevention and treatment measures for chronic diseases, so it is important to select an appropriate HRQoL measurement tool for these patients.

To compare the validity, consistency and correlation of the Chinese Medicinal Quality of Life scale (CQ-11D) , Short-form 6-dimension version 1 (SF-6Dv1) , and the 3-level version of EQ-5D (EQ-5D-3L) in terms of utility values measuring HRQoL in chronic disease patients, and to identify a scale that is most applicable to Chinese chronic disease patients.

From February 2021 to April 2021, this study recruited the initial sample of Chinese people using quota sampling with quotas based on sex and age from a total of 28 representative provinces, autonomous regions or municipalities selected from seven geographical regions (north China, northeast China, east China, central China, southwest China, northwest China, and south China, with 2 to 6 selected from each of the regions) . A face-to-face survey was used to collect the sample people's basic demographic information and the situation of chronic diseases, and self-reported HRQoL measured using the CQ-11D, SF-6Dv1 and EQ-5D-3L, respectively, then according to the survey results, those with chronic diseases were selected, and the utility values of the three scales in them were analyzed. Bland-Altman chart and intraclass correlation coefficient (ICC) were used to analyze the consistency and correlation of the three scales. Kruskal-Wallis H test was used for univariate analysis to determine whether or not there is a statistically significant difference between the utility values of the scales across age or sex groups.

A total of 692 chronic disease patients were finally included. The mean (standard deviation) of utility scores of CQ-11D, SF-6Dv1 and EQ-5D-3L scales were (0.855±0.168) , (0.793±0.132) and (0.876±0.136) , respectively. The top three prevalent chronic diseases were hypertension (n=275) , arthritis (n=128) and hyperlipidemia (n=124) . Histogram showed that EQ-5D-3L had obvious ceiling effect, and CQ-11D was more widely distributed. The Bland-Altman chart showed that the consistency between the three scales was relatively good, and the points within the 95% limits of agreement (LOA) were all about 95%. The strength of correlation between CQ-11D and visual analogue score (VAS) was the highest (P<0.001) . The ICC among the three scales ranged from 0.528 to 0.625, showing a moderate level of correlation (P<0.001) . Both Bland-Altman chart and ICC analysis showed that SF-6Dv1 and EQ-5D-3L had the best consistency. The results of analysis for the three chronic diseases in subgroups were similar to those in the total sample. Univariate analysis showed that male patients with hypertension or hyperlipidemia had higher utility scores of three scales than their female counterparts (P<0.05) . And the utility scores of three scales were the lowest in 60-year-olds and above among patients with hyperlipidemia.

The ceiling effect of EQ-5D-3L scale is obvious in patients with chronic diseases. CQ-11D demonstrated a wide range of distribution of utility values in measuring the three chronic diseases, which may be more suitable for measuring HRQoL in Chinese chronic disease population, as no ceiling effect was observed and its correlation with VAS was the strongest.

我国慢性病患者逐年增加，健康相关生命质量是评价慢性病预防和治疗效果的重要指标，选择合适的慢性病患者健康相关生命质量测量工具有重要意义。

评估中医生命质量评价量表（CQ-11D）、六维健康调查简表第一版（SF-6Dv1）和三水平五维健康量表（EQ-5D-3L）测量慢性病患者健康效用值的效度、一致性和相关性，探索较适用于慢性病患者的量表。

根据中国人口的性别及年龄比例进行配额抽样，2021年2—4月，在华北、东北、华东、华中、西南、西北及华南7个地理区域展开调查，每个分区选取2~6个具有代表性的省、自治区及直辖市（共28个），采用"面对面"调查的方式收集受访者的基本信息与患慢性病情况，并依次收集CQ-11D、SF-6Dv1和EQ-5D-3L的自报结果，从中筛选慢性病患者，对3个量表的效用值测量结果进行分析，采用Bland-Altman图和组内相关系数（ICC）分析3个量表的一致性和相关性，并使用Kruskal-Wallis H检验对性别和年龄进行单因素分析。

研究共纳入692例慢性病患者，CQ-11D、SF-6Dv1和EQ-5D-3L测量总体慢性病患者的效用均值分别为（0.855±0.168）、（0.793±0.132）和（0.876±0.136）。患病人数前三的慢性病分别为高血压（n=275）、关节炎（n=128）和高脂血症（n=124）。直方图显示EQ-5D-3L具有明显的天花板效应，CQ-11D分布范围更广泛；Bland-Altman图显示3个量表间的一致性相对较好，95%一致性区间（LOA）内的点均在95%左右；CQ-11D与视觉模拟评分（VAS）的相关性最高（P<0.001），3个量表间的ICC范围为0.528~0.625，显示出中等水平的相关性（P<0.001），其中Bland-Altman图和ICC分析结果均显示SF-6Dv1与EQ-5D-3L的一致性最好。对3种不同慢性病的亚组分析结果与上述总样本结果相似。单因素分析结果显示，高血压、高脂血症患者中，男性患者3个量表的效用值均高于女性（P<0.05）。高脂血症患者中，3种量表测量效用值最小值均在≥60岁人群。

在慢性病患者中，EQ-5D-3L的天花板效应较为明显。CQ-11D测量3种慢性病效用值范围分布较为广泛，并且未观察到天花板效应，同时与VAS的相关性最高，相对适合测量中国慢性病患者的健康相关生命质量。