Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE®) in breast cancer patients: The prospective observational multicenter VIP study

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast Pub Date : 2024-07-20 DOI:10.1016/j.breast.2024.103781

Caterina Caminiti , Giuseppe Maglietta , Laura Arenare , Raimondo Di Liello , Gessica Migliaccio , Daniela Barberio , Michelino De Laurentiis , Francesca Di Rella , Francesco Nuzzo , Carmen Pacilio , Giovanni Iodice , Michele Orditura , Fortunato Ciardiello , Sara Di Bella , Luigi Cavanna , Camillo Porta , Filippo Giovanardi , Carla Ida Ripamonti , Domenico Bilancia , Giuseppe Aprile , Francesco Perrone

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引用次数: 0

Abstract

Patients’ self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients.

Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients’ reporting of side-effects.

We tested psychometric properties of a selected list of PRO-CTCAE items, in a cohort of 303 breast cancer patients, using validated instruments for quality of life assessment as anchors.

The analysis of convergent validity with HADS (Hospital Anxiety and Depression Scale) and EORTC BR-23 sub-scales, and the analysis of responsiveness with the PGIC (Patients Global Impression of Change) score supported that a selected list of PRO-CTCAE symptoms might represent a standardized, agile tool for both research and practice settings to reduce patient burden without missing relevant information on patient perceptions.

Among patients using digital devices, those with a higher education levels required shorter time to fulfil questionnaires.

In conclusion, a selected list of PRO-CTCAE items can be considered as a standardized, agile tool for capturing crucial domains of side-effects and quality of life in patients with breast cancer.

The study is registered on clinicaltrials.gov (NCT04416672).

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乳腺癌患者患者报告结果通用术语不良事件标准（PRO-CTCAE®）的心理计量特性：前瞻性多中心 VIP 观察研究。

越来越多的人认为，患者的自我报告对于衡量生活质量和与治疗相关的副作用至关重要。然而，如果使用多种患者报告工具，冗余可能会给患者带来过重负担。患者报告结果不良事件通用术语标准（PRO-CTCAE）是一种允许患者直接报告副作用的工具。我们以生活质量评估的有效工具为锚，在 303 名乳腺癌患者中测试了所选 PRO-CTCAE 项目列表的心理测量学特性。与 HADS（医院焦虑和抑郁量表）和 EORTC BR-23 子量表的收敛有效性分析以及与 PGIC（患者全球变化印象）评分的响应性分析均证明，PRO-CTCAE 症状精选列表可能是一种标准化的、灵活的工具，适用于研究和实践环境，既能减轻患者负担，又不会遗漏患者感知方面的相关信息。在使用数字设备的患者中，受教育程度较高的患者填写问卷所需的时间较短。总之，PRO-CTCAE 项目的精选列表可被视为一种标准化的敏捷工具，用于捕捉乳腺癌患者副作用和生活质量的关键领域。该研究已在 clinicaltrials.gov (NCT04416672) 上注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Breast 医学-妇产科学

CiteScore

8.70

自引率

2.60%

发文量

165

审稿时长

59 days

期刊介绍： The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.