Department of Radiation Oncology, Hospital Sírio-Libanês, Rua Dona Adma Jajet 115, Sao Paulo 01308-050, Brazil.
Latin America Cooperative Oncology Group (LACOG), Porto Alegre 90619-900, Brazil.
Curr Oncol. 2021 Aug 31;28(5):3373-3383. doi: 10.3390/curroncol28050291.
This study aimed to validate the Brazilian version of EORTC CAT Core and compare the Brazilian results with those from the original European EORTC CAT Core validation study.
After validated translation, 168 cancer patients from Brazil receiving radiation therapy with or without chemotherapy was assessed. Translated EORTC CAT Core and all QLQ-C30 items were administered to patients using CHES (Computer-Based Health Evaluation System) before (T0) and after (T1) treatment initiation. The association between QLQ-C30 and CAT scores and ceiling/floor effects were estimated. Based on estimates of relative validity (cross-sectional, known-group differences and changes over time), relative sample-size requirements for CAT compared to QLQ-C30 were estimated.
Correlation coefficients between CAT and QLQ-C30 domains ranged from 0.63 to 0.93; except for dyspnoea, all coefficients were >0.82 (corresponding figures were 0.81-0.93 in the European study). On average across domains, floor/ceiling was reduced by 10% using CAT (9% in the European study) corresponding to a relative reduction of 32% (37% in the European study). Analyses of known-group validity and responsiveness indicated that, on average across domains, the sample-size requirements may be reduced by 17% using CAT rather than QLQ-C30, without loss of power (28% in the European study). The Brazilian sample had less symptom/quality of life impairment than the European sample, which likely explains the lower sample-size reduction using CAT when comparing with the European sample.
The results in the Brazilian cohort were generally similar to those from the European sample and confirm the validity and usefulness of the EORTC CAT Core.
本研究旨在验证 EORTC CAT 核心的巴西版本,并将巴西的结果与原始的欧洲 EORTC CAT 核心验证研究结果进行比较。
经过验证的翻译后,对 168 名正在接受放疗或放化疗的巴西癌症患者进行评估。使用 CHES(基于计算机的健康评估系统)在治疗开始前(T0)和治疗开始后(T1)向患者施测 EORTC CAT 核心和所有 QLQ-C30 项目。估计了 QLQ-C30 和 CAT 评分之间的相关性以及天花板/地板效应。基于相对有效性的估计(横断面、已知组间差异和随时间的变化),估计了与 QLQ-C30 相比 CAT 的相对样本量要求。
CAT 与 QLQ-C30 领域之间的相关系数范围为 0.63 至 0.93;除呼吸困难外,所有系数均>0.82(在欧洲研究中相应的数值为 0.81-0.93)。平均而言,在所有领域中,使用 CAT 可降低 10%的地板/天花板效应(在欧洲研究中为 9%),这相当于相对减少 32%(在欧洲研究中为 37%)。对已知组有效性和反应性的分析表明,平均而言,在所有领域中,使用 CAT 而不是 QLQ-C30 可能会减少 17%的样本量需求,而不会降低功效(在欧洲研究中为 28%)。巴西样本的症状/生活质量受损程度低于欧洲样本,这可能解释了与欧洲样本相比,使用 CAT 时样本量减少较少的原因。
巴西队列的结果总体上与欧洲样本相似,证实了 EORTC CAT 核心的有效性和实用性。