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一项比较用于测量HIV感染患者健康相关生活质量的工具的随机研究。西班牙MOS-HIV和MQOL-HIV验证组。医学结局研究HIV健康调查。

A randomized study comparing instruments for measuring health-related quality of life in HIV-infected patients. Spanish MOS-HIV and MQOL-HIV Validation Group. Medical Outcomes Study HIV Health Survey.

作者信息

Badia X, Podzamczer D, Garcia M, López-Lavid C C, Consiglio E

机构信息

Catalan Institute of Public Health, University of Barcelona, L'Hospitalet de Llobregat, Spain.

出版信息

AIDS. 1999 Sep 10;13(13):1727-35. doi: 10.1097/00002030-199909100-00017.

DOI:10.1097/00002030-199909100-00017
PMID:10509575
Abstract

OBJECTIVE

To compare the feasibility, reliability, validity and sensitivity to change of the MOS-HIV and MQOL-HIV in order to determine their suitability for use in clinical research.

METHODS

Five hundred and fifty-eight HIV-infected patients and 80 healthy blood donors were randomly assigned to receive the MOS-HIV or MQOL-HIV. Test-retest reliability was assessed in 98 clinically stable patients, and responsiveness in 296 patients initiating or switching anti-retroviral treatment. Feasibility was assessed using mean time of administration and percentage of missing responses. Reliability was assessed using Cronbach's alpha and the intraclass correlation coefficient (ICC). Construct validity was assessed by correlating questionnaire scores with EuroQol-5D scores, number of symptoms, CD4 cell count and viral load. The area under the curve (AUC) was used for discrimination between patients and healthy donors, and HRQoL scores were compared across disease stage. Responsiveness was assessed by calculating the standardized effect size (SES).

RESULTS

Mean administration time was 16 minutes for both questionnaires. On the MOS-HIV 18.9% patients had missing responses compared with 33.6% on the MQOL-HIV. Cronbach's alpha values were higher for MOS-HIV sub-scales (0.78-0.89) than MQOL-HIV sub-scales (0.44-0.82), and neither instrument showed good test-retest reliability (ICC values of 0.24-0.85 for MOS-HIV versus 0.48-0.82 for MQOL-HIV). AUC values for the MOS-HIV were 0.6-0.86, compared with 0.5-0.79 for the MQOL-HIV, and the MOS-HIV had higher correlations with symptoms (r = -0.28 to 0.79) and EuroQol scores (r = 0.4-0.66) than the MQOL-HIV (r = -0.15 to 0.42 and r = -0.11 to 0.59, respectively). Neither instrument discriminated well between disease stages. Eight of 11 MOS-HIV sub-scales and the Mental Health Summary Score were responsive to change (SES, 0.18-0.36), compared with six of 10 MQOL-HIV sub-scales and MQOL Index (SES, 0.16-0.27).

CONCLUSIONS

Neither instrument demonstrated completely satisfactory psychometric properties for use in clinical research, although the MOS-HIV performed slightly better on feasibility and validity and the MQOL-HIV on test-retest reliability.

摘要

目的

比较MOS-HIV和MQOL-HIV的可行性、可靠性、有效性及对变化的敏感性,以确定它们是否适用于临床研究。

方法

558例HIV感染患者和80名健康献血者被随机分配接受MOS-HIV或MQOL-HIV评估。对98例临床稳定患者评估重测信度,对296例开始或更换抗逆转录病毒治疗的患者评估反应度。通过平均给药时间和缺失回答的百分比评估可行性。使用克朗巴赫α系数和组内相关系数(ICC)评估可靠性。通过将问卷得分与欧洲五维健康量表(EuroQol-5D)得分、症状数量、CD4细胞计数和病毒载量进行相关性分析来评估结构效度。用曲线下面积(AUC)区分患者和健康献血者,并比较不同疾病阶段的健康相关生活质量(HRQoL)得分。通过计算标准化效应量(SES)评估反应度。

结果

两种问卷的平均给药时间均为16分钟。MOS-HIV有18.9%的患者存在缺失回答,而MQOL-HIV为33.6%。MOS-HIV子量表的克朗巴赫α值(0.78 - 0.89)高于MQOL-HIV子量表(0.44 - 0.82),两种工具的重测信度均不佳(MOS-HIV的ICC值为0.24 - 0.85,MQOL-HIV为0.48 - 0.82)。MOS-HIV的AUC值为0.6 - 0.86,而MQOL-HIV为0.5 - 0.79,并且MOS-HIV与症状(r = -0.28至0.79)和欧洲五维健康量表得分(r = 0.4 - 0.66)的相关性高于MQOL-HIV(分别为r = -0.15至0.42和r = -0.11至0.59)。两种工具在区分疾病阶段方面表现均不佳。MOS-HIV的11个子量表中有8个以及心理健康总结得分对变化有反应(SES,0.18 - 0.36),而MQOL-HIV的10个子量表中有6个以及MQOL指数对变化有反应(SES,0.16 - 0.27)。

结论

两种工具在临床研究中的心理测量特性均未完全令人满意,尽管MOS-HIV在可行性和有效性方面表现稍好,而MQOL-HIV在重测信度方面表现稍好。

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