Gallardo-Rincón Dolores, Toledo-Leyva Alfredo, Bahena-González Antonio, Montes-Servín Elizabeth, Pérez-Martín Alejandra Rocío, Montes-Servín Edgar, Alamilla-García Gabriela C, Carmona-Herrera D Darlene, Coronel-Martínez Jaime, Oñate-Ocaña Luis F
Programa de Cáncer de Ovario, Instituto Nacional de Cancerología (INCan), Mexico City, Mexico.
Departamento de Ginecología, Instituto Nacional de Cancerología (INCan), Mexico City, Mexico.
Arch Gynecol Obstet. 2021 Sep;304(3):773-782. doi: 10.1007/s00404-021-05990-3. Epub 2021 Feb 13.
The impact of disease activity or treatments on health-related quality of life (HRQL) is crucial in Oncology, but adequate instruments for this assessment are scarce. Our aim is to validate the Mexican-Spanish version of the QLQ-EN24 questionnaire to evaluate HRQL in women with endometrial cancer (EC).
This is a prospective study of Mexican women with EC, attending a single cancer centre, who responded the QLQ-C30 and QLQ-EN24 instruments; usual psychometric analysis were performed as well as the association of HRQL scales and relevant clinical data. Correlation analysis was performed with the Spearman's method, reliability analysis with the Cronbach's alpha, known-group comparisons with the Kruskal-Wallis test, and survival analysis with the Kaplan-Meier method and Log-rank test.
One hundred and eighty-nine women with EC were assessed. Most functional scales reported high values, and most symptom scales, low. Questionnaire compliance rates were high and internal consistency tests demonstrated adequate convergent and divergent validity. Cronbach's α coefficients of the five multi-item scales the QLQ-EN24 instruments were from 0.659 to 0.887. Scales of the QLQ-C30 and QLQ-EN24 instruments distinguished among clinically distinct groups of patients, particularly based on serum albumin levels. The Urological symptoms, Gastrointestinal symptoms, Body image, Pelvic pain and Taste change scales were significantly associated with OS.
The Mexican-Spanish version of the QLQ-EN24 questionnaire is reliable and valid for the assessment of HRQL in patients with EC and can be broadly used in multi-national clinical trials. However, conclusions derived from scales evaluating sexual function should be handled carefully.
疾病活动或治疗对健康相关生活质量(HRQL)的影响在肿瘤学中至关重要,但用于此评估的适当工具却很稀缺。我们的目的是验证QLQ - EN24问卷的墨西哥西班牙语版本,以评估子宫内膜癌(EC)女性的HRQL。
这是一项对在单一癌症中心就诊的墨西哥EC女性进行的前瞻性研究,这些女性对QLQ - C30和QLQ - EN24工具进行了应答;进行了常规的心理测量分析以及HRQL量表与相关临床数据的关联分析。采用Spearman方法进行相关性分析,采用Cronbach's alpha进行信度分析,采用Kruskal - Wallis检验进行已知组比较,采用Kaplan - Meier方法和Log - rank检验进行生存分析。
对189名EC女性进行了评估。大多数功能量表报告值较高,而大多数症状量表报告值较低。问卷依从率较高,内部一致性检验显示出足够的收敛效度和区分效度。QLQ - EN24工具的五个多项目量表的Cronbach'sα系数在0.659至0.887之间。QLQ - C30和QLQ - EN24工具的量表在临床上不同的患者组中具有区分能力,特别是基于血清白蛋白水平。泌尿系统症状、胃肠道症状、身体形象、盆腔疼痛和味觉改变量表与总生存期显著相关。
QLQ - EN24问卷的墨西哥西班牙语版本对于评估EC患者的HRQL是可靠且有效的,可广泛用于多国临床试验。然而,从评估性功能的量表得出的结论应谨慎处理。