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儿童和青少年EQ-5D量表的测量属性:一项系统评价

Measurement Properties of the EQ-5D Instruments in Children and Adolescents: A Systematic Review.

作者信息

de Melo do Espirito Santo Caique, Santos Verônica Souza, Chiarotto Alessandro, Miyamoto Gisela Cristiane, Yamato Tiê P

机构信息

Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuapé, São Paulo, 03071 - 000, Brazil.

Department of General Practice, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.

出版信息

Appl Health Econ Health Policy. 2025 Apr 19. doi: 10.1007/s40258-025-00953-0.

Abstract

BACKGROUND

The EQ-5D instruments have been widely used to measure health-related quality of life (HRQoL) in child and adolescent populations, especially the EQ-5D-Y-3L and EQ-5D-Y-5L (beta version). Although not specifically designed for younger users, the adult versions (EQ-5D-3L and EQ-5D-5L) are also used in these populations. While the measurement properties of these instruments have been evaluated in children and adolescents, no systematic review to date has employed a rigorous method to assess risk of bias. Additionally, quality criteria for good measurement properties and certainty of evidence have not been thoroughly evaluated. The aim of this study was to summarize and critically appraise the evidence on the measurement properties of all EQ-5D instruments in children and adolescents.

METHODS

We conducted electronic searches on MEDLINE, EMBASE, CINAHL, EconLit, National Health Service Economic Evaluation Database (NHS-EED), and Health Technology Assessment (HTA) databases up to May 2024. We included studies measuring HRQoL using either the self-reported or proxy-reported version of the EQ-5D instruments-EQ-5D-3L, EQ-5D-5L, EQ-5D-Y-3L, and EQ-5D-Y-5L-using the descriptive system, visual analogue scale, and/or utility score in children and adolescents up to 19 years of age, and that tested at least one measurement property (e.g., reliability). The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology was followed to assess risk of bias, to score results for measurement properties, and to perform an evidence synthesis using a modified Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach.

RESULTS

From 3586 records identified through the search, 65 studies were included in this systematic review. We found moderate certainty of evidence of sufficient comprehensibility and comprehensiveness of the EQ-5D-Y-3L and EQ-5D-Y-5L. Furthermore, we found very low certainty of evidence of inconsistent relevance for the EQ-5D-Y-3L, whereas the EQ-5D-Y-5L had sufficient relevance. Almost all the measurement properties (reliability, hypothesis testing for construct validity, and responsiveness) considering all the EQ-5D versions ranged from moderate certainty of evidence of insufficient results to very low certainty of evidence of insufficient results.

CONCLUSION

There is moderate certainty of evidence that the EQ-5D-Y-3L and EQ-5D-Y-5L have sufficient content validity. Both instruments can be recommended to measure HRQoL in children and adolescents aged 8-15 years. However, most of the measurement properties across all EQ-5D versions showed insufficient results, with certainty of evidence ranging from moderate to very low due to inconsistency and doubtful to inadequate risk of bias. Therefore, further research is needed to improve the methodological quality of studies on EQ-5D instruments for children and adolescents.

SYSTEMATIC REVIEW REGISTRATION

International prospective register of systematic reviews (PROSPERO): CRD42020218382 and Open Science Framework: https://osf.io/r8kt9/ .

摘要

背景

EQ-5D量表已被广泛用于测量儿童和青少年人群的健康相关生活质量(HRQoL),尤其是EQ-5D-Y-3L和EQ-5D-Y-5L(试用版)。尽管成人版(EQ-5D-3L和EQ-5D-5L)并非专门为年轻用户设计,但也用于这些人群。虽然这些量表的测量特性已在儿童和青少年中进行了评估,但迄今为止,尚无系统评价采用严格方法评估偏倚风险。此外,对于良好测量特性的质量标准和证据的确定性尚未进行全面评估。本研究的目的是总结并批判性评价所有EQ-5D量表在儿童和青少年中测量特性的证据。

方法

我们在截至2024年5月的MEDLINE、EMBASE、CINAHL、EconLit、国家卫生服务经济评价数据库(NHS-EED)和卫生技术评估(HTA)数据库中进行了电子检索。我们纳入了使用EQ-5D量表(EQ-5D-3L、EQ-5D-5L、EQ-5D-Y-3L和EQ-5D-Y-5L)的自我报告或代理报告版本测量HRQoL的研究,这些研究采用描述系统、视觉模拟量表和/或效用得分,针对19岁及以下的儿童和青少年,且测试了至少一种测量特性(如信度)。遵循基于共识的健康测量工具选择标准(COSMIN)方法来评估偏倚风险,对测量特性的结果进行评分,并使用改良的推荐分级、评估、制定和评价(GRADE)方法进行证据综合。

结果

通过检索识别出3586条记录,本系统评价纳入了65项研究。我们发现,有中等确定性的证据表明EQ-5D-Y-3L和EQ-5D-Y-5L具有足够的可理解性和全面性。此外,我们发现对于EQ-5D-Y-3L,相关性不一致的证据确定性非常低,而EQ-5D-Y-5L具有足够的相关性。考虑所有EQ-5D版本的几乎所有测量特性(信度、结构效度的假设检验和反应度),证据确定性从中等(结果不足)到非常低(结果不足)不等。

结论

有中等确定性的证据表明,EQ-5D-Y-3L和EQ-5D-Y-5L具有足够的内容效度。这两种量表均可推荐用于测量8至15岁儿童和青少年的HRQoL。然而,所有EQ-5D版本的大多数测量特性结果均不充分,由于不一致以及偏倚风险可疑或不足,证据确定性从中等到非常低。因此,需要进一步研究以提高关于儿童和青少年EQ-5D量表研究的方法学质量。

系统评价注册

国际系统评价前瞻性注册库(PROSPERO):CRD42020218382和开放科学框架:https://osf.io/r8kt9/

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