Departamento de Dermatología, Hospital del Mar, Parc de Salut Mar, IMIM, Universitat Autònoma de Barcelona.
Grupo de Investigación en Servicios Sanitarios, Instituto Hospital del Mar de Investigaciones Médicas.
Actas Dermosifiliogr (Engl Ed). 2020 Apr;111(3):243-248. doi: 10.1016/j.ad.2019.11.003. Epub 2020 Jan 25.
Mastocytosis encompasses a spectrum of disorders in which different organs and tissues are affected by the clonal expansion of mast cells. The skin is one of the most frequently affected organs. The clinical manifestations of mastocytosis are linked to the release of proinflammatory mediators, and the impact of this disorder on patient quality of life has been described in various studies. The Mastocytosis Quality of Life Questionnaire (MC-QoL), which was recently developed in Germany and now also exists in English, is an important tool for evaluating the psychosocial impact of this disease.
To create a Spanish version of the MC-QoL that was culturally equivalent to the original German questionnaire.
The adaptation process, which involved forward translation, cognitive interviews, and back translation, was conducted in accordance with the principles of good practice for the translation and cultural adaptation of patient-reported measures of the International Society for Pharmacoeconomics and Outcomes Research. The MC-QoL contains 27 items in 4 domains: symptoms, emotions, social life/functioning, and skin.
The first version of the Spanish questionnaire, obtained by forward translation from German, was tested in cognitive interviews, after which 3 items were modified to make them easier to understand. The German back translation of the Spanish questionnaire was analyzed by the authors of the original MC-QoL, who modified 1 item they considered to have lost specificity in the adaptation process. The definitive Spanish MC-QoL was then produced following minor modifications agreed on with the German authors.
We have produced a cultural adaptation of the MC-QoL in Spanish that can be used in routine clinical practice to obtain a more complete picture of the impact of mastocytosis on patient quality of life.
肥大细胞增多症包括一系列疾病,其中不同的器官和组织受到肥大细胞克隆性扩张的影响。皮肤是最常受影响的器官之一。肥大细胞增多症的临床表现与促炎介质的释放有关,该疾病对患者生活质量的影响已在多项研究中描述。肥大细胞增多症生活质量问卷(MC-QoL)是一种重要的工具,用于评估这种疾病的心理社会影响,该问卷最近在德国开发,现在也有英文版本。
创建与原始德国问卷在文化上等效的 MC-QoL 的西班牙语版本。
根据国际药物经济学和结果研究学会(ISPOR)患者报告测量结果的翻译和文化适应性良好实践原则,进行了适应性翻译过程,包括正向翻译、认知访谈和反向翻译。MC-QoL 包含 4 个领域的 27 个项目:症状、情绪、社会生活/功能和皮肤。
通过正向翻译从德语获得的西班牙语问卷的第一版在认知访谈中进行了测试,之后修改了 3 个项目以使其更易于理解。西班牙语问卷的德国反向翻译由 MC-QoL 的原始作者进行分析,他们修改了 1 个他们认为在适应过程中失去特异性的项目。根据与德国作者达成的共识,对小部分内容进行修改后,最终产生了西班牙语 MC-QoL。
我们已经完成了 MC-QoL 的西班牙语文化适应性翻译,可用于常规临床实践,以更全面地了解肥大细胞增多症对患者生活质量的影响。