欧洲癌症患者和幸存者生活质量自我评估工具包（EUonQoL-Kit）的验证：一项泛欧洲调查的研究方案

Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European survey.

作者信息

Apolone G, Costantini M, Caselli L, Bos N, Caraceni A, Ciliberto G, Couespel N, Ferrer M, Groenvold M, Kaasa S, Lombardo C, Pietrobon R, Pravettoni G, Sirven A, Vachon H, Velikova G, Garin O, Gilbert A, Machiavelli A, Marzorati C, Miceli R, Pe M, Petersen M A, Tanzilli A, van Schelven F, Dantas C, Minnée-van Braak I, Pinnavaia L, Brunelli C

机构信息

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Lombardia, Italy.

Netherlands Institute for Health Services Research (Nivel), Utrecht, The Netherlands.

出版信息

BMC Public Health. 2024 Dec 18;24(1):3517. doi: 10.1186/s12889-024-21008-4.

DOI:10.1186/s12889-024-21008-4

PMID:39696103

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11657460/

Abstract

BACKGROUND

European cancer programmes and policies lack a unified health-related quality of life (HRQoL) assessment tool. The European oncology quality of life toolkit (EUonQoL-Kit) is a novel set of HRQoL questionnaires, co-designed with cancer patients and survivors, translated and culturally adapted into 31 European languages, and with both static and dynamic electronic administration modes. The main aim of this study is the psychometric assessment of the static version. Secondary aims include evaluating the EUonQoL-Kit acceptability, cross-validating the administration modes, exploring individual factors potentially affecting HRQoL and HRQoL inequalities between countries.

METHODS

A sample of 4,500 participants, including three groups (active treatment, survivors, and palliative care) from 45 centres in 25 EU Member States and 7 associated countries, will be enrolled in a multicentre observational cross-sectional study. All participants will complete the static EUonQoL-Kit; three subsamples (each 10% of the total sample) will also respectively complete the following: a) dynamic EUonQoL-Kit, based on Item Response Theory (IRT)/Computer Adaptive Testing (CAT), b) FACT-G and EQ-5L-5D, and c) static EUonQoL-Kit (re-test). Psychometric analyses will encompass exploratory and confirmatory factor analyses (measurement model and structural validity), Cronbach's alpha (internal consistency), intraclass correlation coefficient (test-retest reliability), Pearson/Spearman correlation (concurrent validity), comparison of group scores (construct validity), and Differential Item Functioning (cross-country item equivalence). Secondary analyses will evaluate participant response time and rate, and static/dynamic score differences. Regression models will estimate associations between individual factors and HRQoL.

DISCUSSION

The EUonQoL-Kit will serve to systematically incorporate patient perspectives into European cancer policies and to address HRQoL inequalities across Europe.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05947903, 2023-06-28.

摘要

背景

欧洲的癌症项目和政策缺乏一个统一的健康相关生活质量（HRQoL）评估工具。欧洲肿瘤生活质量工具包（EUonQoL-Kit）是一套全新的HRQoL问卷，与癌症患者及幸存者共同设计，已被翻译成31种欧洲语言并进行了文化适应性调整，具备静态和动态电子管理模式。本研究的主要目的是对静态版本进行心理测量评估。次要目的包括评估EUonQoL-Kit的可接受性、对管理模式进行交叉验证、探索可能影响HRQoL的个体因素以及各国之间的HRQoL不平等情况。

方法

将招募4500名参与者作为样本，这些参与者来自25个欧盟成员国和7个相关国家的45个中心，分为三组（积极治疗组、幸存者组和姑息治疗组），参与一项多中心观察性横断面研究。所有参与者都将完成静态的EUonQoL-Kit；三个子样本（各占总样本的10%）还将分别完成以下内容：a）基于项目反应理论（IRT）/计算机自适应测试（CAT）的动态EUonQoL-Kit，b）FACT-G和EQ-5L-5D，以及c）静态EUonQoL-Kit（重测）。心理测量分析将包括探索性和验证性因素分析（测量模型和结构效度）、克朗巴哈α系数（内部一致性）、组内相关系数（重测信度）、皮尔逊/斯皮尔曼相关性（同时效度）、组分数比较（结构效度）以及差异项目功能（跨国项目等效性）。次要分析将评估参与者的反应时间和比率，以及静态/动态分数差异。回归模型将估计个体因素与HRQoL之间的关联。