Department of Psychiatry, Psychotherapy, Psychosomatics, and Medical Psychology, University Hospital of Psychiatry I, Innsbruck Medical University, Anichstraße 35, A-6020, Innsbruck, Austria.
Professorship for Psychological Diagnostics and Intervention Psychology, Faculty of Philosophy and Education, Catholic University of Eichstätt-Ingolstadt, Ostenstraße 25, 85072, Eichstätt, Germany.
BMC Med Res Methodol. 2023 Jan 21;23(1):21. doi: 10.1186/s12874-022-01826-z.
Patient-reported physical function (PF) is a key endpoint in cancer clinical trials. Using complex statistical methods, common metrics have been developed to compare scores from different patient-reported outcome (PRO) measures, but such methods do not account for possible differences in questionnaire content. Therefore, the aim of our study was a content comparison of frequently used PRO measures for PF in cancer patients.
Relying on the framework of the International Classification of Functioning, Disability and Health (ICF) we categorized the item content of the physical domains of the following measures: EORTC CAT Core, EORTC QLQ-C30, SF-36, PROMIS Cancer Item Bank for Physical Function, PROMIS Short Form for Physical Function 20a, and the FACT-G. Item content was linked to ICF categories by two independent reviewers.
The 118 items investigated were assigned to 3 components ('d - Activities and Participation', 'b - Body Functions', and 'e - Environmental Factors') and 11 first-level ICF categories. All PF items of the EORTC measures but one were assigned to the first-level ICF categories 'd4 - Mobility' and 'd5 - Self-care', all within the component 'd - Activities and Participation'. The SF-36 additionally included item content related to 'd9 - Community, social and civic life' and the PROMIS Short Form for Physical Function 20a also included content related to 'd6 - domestic life'. The PROMIS Cancer Item Bank (v1.1) covered, in addition, two first-level categories within the component 'b - Body Functions'. The FACT-G Physical Well-being scale was found to be the most diverse scale with item content partly not covered by the ICF framework.
Our results provide information about conceptual differences between common PRO measures for the assessment of PF in cancer patients. Our results complement quantitative information on psychometric characteristics of these measures and provide a better understanding of the possibilities of establishing common metrics.
患者报告的身体功能（PF）是癌症临床试验的关键终点。使用复杂的统计方法，已经开发出常用指标来比较来自不同患者报告的结局（PRO）测量的分数，但这些方法没有考虑问卷内容的可能差异。因此，我们的研究目的是对癌症患者 PF 常用 PRO 测量进行内容比较。
我们根据国际功能、残疾和健康分类（ICF）的框架，对以下措施的身体领域的项目内容进行分类：EORTC CAT 核心、EORTC QLQ-C30、SF-36、PROMIS 癌症身体功能项目库、PROMIS 身体功能简短形式 20a 和 FACT-G。两位独立审查员将项目内容与 ICF 类别联系起来。
调查的 118 个项目被分配到 3 个组成部分（“d - 活动和参与”、“b - 身体功能”和“e - 环境因素”）和 11 个一级 ICF 类别。EORTC 测量的所有 PF 项目都被分配到一级 ICF 类别“d4 - 移动性”和“d5 - 自我护理”，都属于“d - 活动和参与”组成部分。SF-36 还包括与“d9 - 社区、社会和公民生活”相关的项目内容，而 PROMIS 身体功能简短形式 20a 还包括与“d6 - 家庭生活”相关的内容。PROMIS 癌症项目库（v1.1）还涵盖了组成部分“b - 身体功能”内的两个一级类别。FACT-G 身体幸福感量表是最具多样性的量表，其项目内容部分未涵盖 ICF 框架。
我们的结果提供了关于癌症患者 PF 评估常用 PRO 测量之间概念差异的信息。我们的结果补充了这些措施的心理测量特征的定量信息，并提供了对建立通用指标的可能性的更好理解。
