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创伤后应激障碍青少年和年轻成人健康状况评估和估值的 EQ-5D-5L 的可靠性、有效性和反应度:一项随机对照试验。

Reliability, Validity and Responsiveness of the EQ-5D-5L in Assessing and Valuing Health Status in Adolescents and Young Adults with Posttraumatic Stress Disorder: a Randomized Controlled Trail.

机构信息

Department of Health Economics and Health Services Research, Hamburg Center for Health Economics (HCHE), University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.

Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.

出版信息

Psychiatr Q. 2021 Jun;92(2):459-471. doi: 10.1007/s11126-020-09814-6.

Abstract

To validate the EQ-5D-5L health-related quality of life (HrQoL) questionnaire in adolescents and young adults with posttraumatic stress disorder (PTSD) after sexual and/or physical abuse. We used data from a randomized controlled trial of 87 participants with PTSD aged 14-21 years. The discriminative ability was evaluated by comparing participants scores on the descriptive system of the EQ-5D-5L with general population scores. Furthermore, the discriminative ability between subgroups of participants with different disease severity levels was estimated. Correlations between the EQ-5D index and clinical parameters were used to measure construct validity. Test-retest reliability was measured by intraclass correlation coefficients (ICC) between baseline, posttreatment and 3-month follow-up scores of participants with stable symptoms. Finally, the responsiveness of the EQ-5D was calculated by mean differences, effect sizes and receiver operating characteristic (ROC) analyses for participants with improved symptoms. Participants reported significantly more problems on the dimensions "mobility", "usual activities", "pain/discomfort" and "anxiety/depression" than the general population. The EQ-5D-5L was able to discriminate between different disease severity levels. The EQ-5D index and clinical scales were significantly correlated with absolute values of correlation coefficients varying between 0.21 and 0.59. Furthermore, ICCs between 0.65 and 0.91 indicated good test-retest reliability for the EQ-5D index. The ICCs for the EQ-VAS between baseline and 3-month follow-up, and posttreatment and 3-month follow-up were statistically significant with 0.71 and 0.87, respectively, whereas the ICC between baseline and posttreatment was 0.08 and not statistically significant. Effect sizes to measure the responsiveness ranged between -0.008 and 0.40 for the EQ-5D index and - 0.32 and 0.40 for the EQ-VAS. Furthermore, the area under the curve in ROC analyses was between 0.40 and 0.64 for the EQ-5D index and 0.60 and 0.70 for the EQ-VAS. Discriminative ability, test-retest reliability and construct validity of the EQ-5D-5L were good, whereas the responsiveness was rather weak. Nevertheless, the EQ-5D-5L can be used to measure HrQoL in adolescents and young adults with PTSD. German Clinical Trials Register identifier: DRKS00004787; date of registration: 18th March 2013; https://www.drks.de.

摘要

评估青少年和年轻成年人创伤后应激障碍(PTSD)患者使用 EQ-5D-5L 健康相关生活质量(HrQoL)问卷的效度。我们使用了一项 87 名 14-21 岁 PTSD 患者的随机对照试验的数据。区分能力通过比较参与者在 EQ-5D-5L 描述系统中的评分与一般人群的评分来评估。此外,还估计了不同疾病严重程度水平的参与者亚组之间的区分能力。EQ-5D 指数与临床参数之间的相关性用于测量结构效度。对于症状稳定的参与者,使用基线、治疗后和 3 个月随访的参与者的组内相关系数(ICC)测量测试-重测信度。对于症状改善的参与者,使用均差、效应大小和接收器操作特征(ROC)分析计算 EQ-5D 的反应性。与一般人群相比,参与者在“移动性”、“日常活动”、“疼痛/不适”和“焦虑/抑郁”维度上报告了更多的问题。EQ-5D-5L 能够区分不同的疾病严重程度水平。EQ-5D 指数与临床量表呈显著相关,相关系数的绝对值在 0.21 到 0.59 之间。此外,EQ-5D 指数的 ICC 值在 0.65 到 0.91 之间,表明 EQ-5D 指数具有良好的测试-重测信度。EQ-VAS 基线与 3 个月随访、治疗后与 3 个月随访之间的 ICC 值分别为 0.71 和 0.87,具有统计学意义,而基线与治疗后之间的 ICC 值为 0.08,无统计学意义。用于测量反应性的效应大小范围为 EQ-5D 指数为-0.008 至 0.40,EQ-VAS 为-0.32 至 0.40。此外,ROC 分析中曲线下面积(AUC)为 EQ-5D 指数为 0.40 至 0.64,EQ-VAS 为 0.60 至 0.70。EQ-5D-5L 的区分能力、测试-重测信度和结构效度良好,而反应性较弱。然而,EQ-5D-5L 可用于测量 PTSD 青少年和年轻成年人的 HrQoL。德国临床试验注册标识:DRKS00004787;注册日期:2013 年 3 月 18 日;https://www.drks.de。

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