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英国对 EQ-5D-5L 的评估,一种通用的健康相关生活质量衡量标准:研究方案。

UK Valuation of EQ-5D-5L, a Generic Measure of Health-Related Quality of Life: A Study Protocol.

机构信息

Sheffield Centre for Health and Related Research, University of Sheffield, Sheffield, England, UK.

Sheffield Centre for Health and Related Research, University of Sheffield, Sheffield, England, UK.

出版信息

Value Health. 2023 Nov;26(11):1625-1635. doi: 10.1016/j.jval.2023.08.005. Epub 2023 Sep 16.

Abstract

OBJECTIVES

A high-quality and widely accepted UK EQ-5D-5L value set is urgently required to enable the latest version of EQ-5D scored using recent UK public preferences to inform policy including health technology assessments submitted to the National Institute for Health and Care Excellence. This article outlines the study protocol for the generation of a new EQ-5D-5L UK value set.

METHODS

Twelve hundred interviews will be undertaken using the composite time trade-off elicitation technique for 102 health states (86 from the international EQ-5D-5L valuation protocol, plus 16 with best predictive performance in an extended design used in the Native American EQ-5D-5L valuation). The sample will be UK adults (age ≥18 years) proportionately representative across England, Wales, Scotland, and Northern Ireland, representative for age, sex, ethnicity, and socioeconomic group, with inclusion of participants with/without health problems. Participants will choose to be interviewed via videoconference (by Zoom) or in-person in a central venue. Data quality will be rigorously assessed.

RESULTS

The value set will be generated using tobit random effects and heteroscedastic tobit models (with censoring at -1) using all data, excluding time trade-off values highlighted by participants as ones they would reconsider and data from interviewers failing protocol compliance. Quality and acceptance will be achieved by public involvement, regular Steering Group meetings, independent assessment of data quality at 4 time points, and final endorsement of data and analyses.

CONCLUSION

This study will produce a UK value set for the EQ-5D-5L for use in prospective and retrospective data sets containing EQ-5D-5L data.

摘要

目的

需要高质量且广泛认可的英国 EQ-5D-5L 值集,以便使用最近英国公众偏好对最新版本的 EQ-5D 进行评分,为政策提供信息,包括提交给国家卫生与保健卓越研究所的卫生技术评估。本文概述了生成新的英国 EQ-5D-5L 值集的研究方案。

方法

将使用复合时间权衡 elicitation 技术对 102 个健康状态(86 个来自国际 EQ-5D-5L 估值协议,另外 16 个来自扩展设计中在美洲原住民 EQ-5D-5L 估值中表现最佳的健康状态)进行 1200 次访谈。样本将是英格兰、威尔士、苏格兰和北爱尔兰的英国成年人(年龄≥18 岁),按年龄、性别、族裔和社会经济群体比例代表,包括有/无健康问题的参与者。参与者将选择通过视频会议(使用 Zoom)或在中心地点进行面对面访谈。将严格评估数据质量。

结果

将使用 tobit 随机效应和异方差 tobit 模型(在-1 处进行 censoring)生成值集,使用所有数据,排除参与者标记为可能重新考虑的时间权衡值和违反协议的访谈员的数据。通过公众参与、定期指导小组会议、4 个时间点的数据质量独立评估以及最终对数据和分析的认可来实现质量和可接受性。

结论

这项研究将为 EQ-5D-5L 生成英国值集,用于包含 EQ-5D-5L 数据的前瞻性和回顾性数据集。

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