Scott Stephanie Suzanne de Oliveira, Martins Ana Carolina, Furtado Gabriel Vasata, Donis Karina Carvalho, Prolla Helena Ashton, Lacroix Laura Prolla, Brandi Ana Laura, Santana Karine Caregnato, Nóbrega Paulo Ribeiro, Braga-Neto Pedro, Jardim Laura Bannach
Programa de Pós-Graduação em Ciências Médicas, Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, Brazil.
Departamento de Medicina Clínica, Universidade Federal do Ceará, Fortaleza, Brazil.
Cerebellum. 2025 May 24;24(4):105. doi: 10.1007/s12311-025-01857-4.
Patient-Reported Outcome Measure (PROMs) are essential instruments for assessing outcomes in clinical trials, as they represent, in a standardized way, the direct report of patients about their own experiences with the disease. To better understand the health and well-being of the population with ataxia, the Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia) was developed in English.
to translate the PROM-Ataxia to Portuguese and culturally adapt it for use in Brazil.
We followed the ISPOR TCA Task Force guidelines. Researchers from two geographically and culturally distant ataxia care centers, located 4,200 km apart, produced two initial versions in Portuguese. The reconciled version was back translated, improved by the opinion of other specialists in ataxia in the country, and sent to the original author, who approved the preliminary Brazilian version. This version was then taken to cognitive debriefing with ataxic patients followed at one of the two participant sites - Porto Alegre and Fortaleza.
Fourteen Brazilian patients participated in the debriefing. They found PROM-ataxia to be adequate and to cover all the significant impacts of ataxia on their lives. Some items were considered ambiguous. Semantic and conceptual issues were identified and resolved with minor translation changes that improved the cross-cultural adaptation of the questionnaire.
The Brazilian version of PROM-ataxia is now complete. Further psychometric studies are needed to validate its efficacy as an outcome measure, particularly in clinical trials.
Not applicable.
患者报告结局量表（PROMs）是评估临床试验结局的重要工具，因为它们以标准化的方式代表了患者对自身疾病经历的直接报告。为了更好地了解共济失调患者的健康状况和生活质量，已用英文编制了共济失调患者报告结局量表（PROM-Ataxia）。
将PROM-Ataxia翻译成葡萄牙语，并在文化上进行调整以用于巴西。
我们遵循了国际药物经济学和结果研究协会（ISPOR）TCA工作组的指南。来自两个地理位置和文化背景相距甚远（相距4200公里）的共济失调护理中心的研究人员编制了两个葡萄牙语初始版本。对协调后的版本进行回译，根据该国其他共济失调专家的意见进行改进，然后发送给原作者，原作者批准了巴西初步版本。然后将该版本带到两个参与地点之一（阿雷格里港和福塔雷萨）随访的共济失调患者中进行认知反馈。
14名巴西患者参与了反馈。他们发现PROM-ataxia足够全面，涵盖了共济失调对他们生活的所有重大影响。一些项目被认为含糊不清。识别并解决了语义和概念问题，并进行了微小的翻译更改，从而改进了问卷的跨文化适应性。
PROM-ataxia的巴西版本现已完成。需要进一步的心理测量学研究来验证其作为结局测量工具的有效性，特别是在临床试验中。
不适用。
