Adelphi Values, Patient-Centered Outcomes, Bollington, Cheshire, UK.
Formerly of Adelphi Values, Patient-Centered Outcomes, Bollington, Cheshire, UK.
Eur J Cancer. 2023 Jan;178:128-138. doi: 10.1016/j.ejca.2022.10.026. Epub 2022 Nov 1.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) is among the most widely used patient-reported outcome measures in cancer research and practice. It was developed prior to guidance that content should be established directly from patients to confirm it measures concepts of interest and is appropriate and comprehensive for the intended population. This study evaluated the content validity of the QLQ-C30 for use with cancer patients.
Adults undergoing cancer treatment in Europe and the USA participated in open-ended concept elicitation interviews regarding their functional health, symptoms, side-effects and impacts on health-related quality of life. Thematic analysis was conducted, and similarities across cancer types, disease stages and countries or languages were explored.
Interviews with 113 patients with cancer (85 European, 28 USA) including breast, lung, prostate, colorectal and other cancers were conducted between 2016 and 2020. Conceptual saturation was achieved. The most frequently reported concepts were included in the QLQ-C30 conceptual framework. QLQ-C30 items were widely understood across language versions and were relevant to patients across cancer types and disease stages. While several new concepts were elicited such as difficulty climbing steps or stairs, weight loss, skin problems and numbness, many were not widely experienced and/or could be considered sub-concepts of existing concepts.
The QLQ-C30 demonstrates good evidence of content validity for the assessment of functional health, symptom burden and health-related quality of life in patients with localised-to-advanced cancer.
欧洲癌症研究与治疗组织生活质量问卷核心 30 项（QLQ-C30）是癌症研究和实践中使用最广泛的患者报告结局测量之一。它是在没有指导的情况下开发的，内容应该直接来自患者，以确认它是否测量了感兴趣的概念，并且对于预期人群是适当和全面的。本研究评估了 QLQ-C30 在癌症患者中的内容效度。
在欧洲和美国接受癌症治疗的成年人参加了关于他们的功能健康、症状、副作用以及对健康相关生活质量的影响的开放式概念挖掘访谈。进行了主题分析，并探讨了癌症类型、疾病阶段和国家或语言之间的相似之处。
2016 年至 2020 年间，对 113 名癌症患者（85 名欧洲人，28 名美国人）进行了访谈，包括乳腺癌、肺癌、前列腺癌、结直肠癌和其他癌症。达到了概念饱和。报告最多的概念被纳入 QLQ-C30 概念框架。QLQ-C30 项目在语言版本之间被广泛理解，并且与癌症类型和疾病阶段的患者相关。虽然引出了一些新的概念，如爬楼梯困难、体重减轻、皮肤问题和麻木，但许多概念并不常见，或者可以被认为是现有概念的子概念。
QLQ-C30 为评估局限性至晚期癌症患者的功能健康、症状负担和健康相关生活质量提供了良好的内容有效性证据。
