METHODS: The guidelines for translation and cross-cultural adaptation of health-related QoL measures were followed. Initially, two separate translations were generated for each questionnaire, and subsequently reconciled by an expert committee. This was followed by a back-translation process. The original texts and all translations underwent revision by the expert committee, resulting in definitive versions. The final versions were then tested in a pilot study involving cognitive debriefing in a group of 17 families, representative of all EB major types.
RESULTS: The translation and reconciliation process led to minor changes to obtain semantic/idiomatic/cultural equivalence of the Italian versions with the original ones and to reconcile the questions with the answer options. The cognitive debriefing process showed a good understanding and did not require text modifications.
CONCLUSIONS: The Italian versions of the QOLEB and EB-BoD provide valuable tools in everyday clinical practice of reference centers, and they allow the participation in multicenter international real-life observational studies as well as in controlled clinical trials. They enable the identification of disease-specific psychological and socioeconomic challenges for EB patients and their families, guiding targeted interventions to ensure appropriate and timely care.
方法:遵循与健康相关的QoL测量的翻译和跨文化适应指南。最初,为每个问卷生成两个单独的翻译,随后由专家委员会和解。随后是反向翻译过程。原文和所有译文都经过专家委员会的修订,导致最终版本。然后在一项涉及17个家庭的认知汇报的试点研究中测试了最终版本,所有EB主要类型的代表。
结果:翻译和协调过程导致了微小的变化,以获得意大利语版本与原始版本的语义/惯用/文化对等,并使问题与答案选项相协调。认知汇报过程显示出很好的理解,不需要文本修改。
结论:QOLEB和EB-BoD的意大利语版本为参考中心的日常临床实践提供了有价值的工具,它们允许参与多中心国际现实生活观察研究以及对照临床试验。它们能够为EB患者及其家人识别特定疾病的心理和社会经济挑战,指导有针对性的干预措施,以确保适当和及时的护理。