【摘要】 目的 探讨儿童健康效用9维(CHU9D)量表和欧洲生命质量学会5维量表-青少年版(EQ-5D-Y),评估急性淋巴细胞白血病(ALL)患儿健康效用值的一致性及相关性。方法 选择2020年4月至2021年4月，于青海大学附属医院诊疗的85例ALL患儿(8～14岁)为研究对象。对其先采用EQ-5D-Y,间隔3 d,再采用CHU9D量表进行问卷调查，分别计算2个量表的健康效用值，评估患儿健康相关生命质量(HRQoL)。采用独立样本t检验或单因素方差分析，对受试儿的不同人口统计学变量及健康状况，采用上述2个量表的健康效用值进行统计学比较；分别采用同类相关系数(ICC)及绘制Bland-Altman散点图，评估纳入研究患儿2个量表健康效用值的一致性水平及一致性限度；采用Pearson相关性分析法，分别对2个量表的健康效用值相关性、各维度之间相关性进行分析。本研究通过青海大学附属医院伦理委员会批准(审批文号：QHG0223A),征得患儿及其监护人知情同意，并签署临床研究知情同意书。结果 (1)2个量表评估均显示：男性、来自双亲家庭、家庭年收入≥10万元及健康状况好患儿的健康效用值，分别高于女性、来自单亲家庭(离异)、家庭年收入≤5万元及健康状况中等者，并且差异均有统计学意义(P均<0.05)。(2)本研究纳入患儿2个量表评估的健康效用值呈正相关关系(r=0.659,P<0.001)。对于EQ-5D-Y量表健康效用值≤0.3和健康效用值为1.0的患儿，其CHU9D量表健康效用值显著偏低，并且差异均有统计学意义(P<0.05)。(3)本研究纳入患儿EQ-5D-Y和CHU9D量表评估的健康效用值分别为(0.780±0.160)和(0.755±0.164),ICC为0.793(95%CI:0.682～0.866,P<0.001)。Bland-Altman分析显示，EQ-5D-Y与CHU9D量表健康效用值差值的平均值为-0.02,差值的绝对值最大为0.29。(4)2个量表的“疼痛”维度具有最高相关性(r=0.697);EQ-5D-Y量表的“焦虑或压抑”维度，分别与CHU9D量表的“伤心”维度(r=0.614)与“发愁”维度(r=0.596)相关性均较高。EQ-5D-Y量表的“自我照顾”“日常活动”维度，分别与CHU9D量表的9个维度相关性均较差(r=0.109～0.459)。结论 2个量表均可被用于评估ALL患儿HRQoL。CHU9D量表对健康效用值变化更敏感，并且2个量表不可相互替代。更多还原

【Abstract】 Objective To explore consistency and correlation of health utility values assessed by Child Health Utility 9D(CHU9D) scale and Euroqol Five Dimensions Questionnaire-Youth Version(EQ-5D-Y) in children with acute lymphoblastic leukemia(ALL). Methods From April 2020 to April 2021, a total of 85 children with ALL(aged 8-14 years old) diagnosed and treated in Qinghai University Affiliated Hospital were selected as subjects. According to questionnaire results of EQ-5D-Y and CHU9D scale(after an interval of 3 d), health utility values of 2 scales were calculated respectively to assess health-related quality of life(HRQoL) of subjects. Independent-samples t test and ANOVA were used to statistically compare health utility values of 2 scales among subjects with different demographic variables and health status. Intraclass correlation coefficient(ICC) and Bland-Altman scatter diagram were used respectively to assess consistency level and consistency limits of health utility values of subjects between 2 scales. Pearson correlation analysis was used to analyze correlation between health utility values of 2 scales, and correlation between dimensions of 2 scales. The study was approved by Ethics Committee of Qinghai University Affiliated Hospital(Approval No. QHG0223A), and obtain informed consent of subjects and their guardians, and sign informed consent forms of clinical study. Results(1) Evaluating of both scales showed that health utility values of males, from two-parent families, annual household income ≥ 100 000 yuan and in good health condition of subjects were higher than those females, from divorced families, annual household income ≤ 50 000 yuan and in moderate health condition, respectively, and the differences were statistically significant(all P<0.05).(2) There was a positive correlation between health utility values assessed by 2 scales(r=0.659, P<0.001). Subjects with health utility values ≤0.3 and health utility values of 1.0 on EQ-5D-Y scale had higher health utility values on EQ-5D-Y scale than those on CHU9D scale, and the differences were statistically significant(P<0.05).(3) Health utility values assessed by EQ-5D-Y and CHU9D scales for subjects were(0.780±0.160) and(0.755±0.164), respectively, ICC=0.793(95%CI: 0.682-0.866, P<0.001) of 2 scales. Bland-Altman analysis showed that mean value of difference in health utility values between EQ-5D-Y and CHU9D scales was-0.02, with the largest absolute value of the difference being 0.29.(4) Dimension of "pain" had the highest correlation between two scales(r=0.697); dimension of "anxiety or depression" of EQ-5D-Y scale had high correlation with dimension of "sadness"(r=0.614) and "worry"(r=0.596) of CHU9D scale, respectively. There were poor correlations of dimension of "self-care" and "daily activities" of EQ-5D-Y scale between each dimension of CHU9D scale respectively(r=0.109-0.459). Conclusions Both scales may be more widely used to assess HRQoL of children with ALL. CHU9D scale is more sensitive to changes in health utility values and two scales are not interchangeable.更多还原