Danish Center for Health Services Research, Aalborg University Hospital and Aalborg University , Aalborg, Denmark.
Department of Physical and Occupational Therapy, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, 8200, Denmark.
J Patient Rep Outcomes. 2024 Feb 26;8(1):21. doi: 10.1186/s41687-024-00698-9.
Most patient-reported outcome (PROs) used in thrombosis research and clinical practice are delivered using technology like online questionnaires. However, only few have undergone formal electronic adaptation from paper to digital versions, threatening the validity and reliability of the PROs. The present study aimed to perform an electronic adaption and cross-cultural translation of two PROs measuring health-related quality of life in a Danish cohort of patients with venous thrombosis (VTE), specifically the VEINES-QoL/Sym questionnaire and the PEmb-QoL questionnaire.
The electronic adaption and cross-cultural translation processes followed the international guidelines recommended by ISPOR. The migration of the questionnaires from paper to electronic versions was conducted in the Research Electronic Data Capture (REDCap). Following approval of the electronically adapted and translated versions, a pretest of the questionnaires was performed by cognitive interviewing patients with VTE recruited from a hospital setting.
Nine men and ten women between the age of 19 and 73 years participated in cognitive interviews. The questionnaires were successfully adapted from paper to electronic versions, and during the migration process only a few modifications to the content and format were made. Most comments were related to technicalities, e.g. touch functions and checkboxes. The cross-cultural translation of both questionnaires was satisfactory, as only minor rephrasing was required.
The original and Danish version of VEINES-QoL/Sym and PEmb-QoL were successfully adapted into electronic versions and are ready to share for REDCap users. Furthermore, the Danish versions of the two questionnaires have shown satisfactory face validity.
大多数用于血栓形成研究和临床实践的患者报告结局（PROs）都是通过在线问卷等技术提供的。然而，只有少数经过了从纸质版到电子版的正式电子改编，这威胁到了 PROs 的有效性和可靠性。本研究旨在对丹麦静脉血栓形成（VTE）患者队列中测量健康相关生活质量的两项 PROs（即 VEINES-QoL/Sym 问卷和 PEmb-QoL 问卷）进行电子改编和跨文化翻译。
电子改编和跨文化翻译过程遵循了 ISPOR 推荐的国际指南。问卷从纸质版到电子版的迁移是在 Research Electronic Data Capture（REDCap）中进行的。在批准电子改编和翻译版本后，对从医院环境招募的 VTE 患者进行了认知访谈预测试。
9 名年龄在 19 至 73 岁之间的男性和 10 名女性参加了认知访谈。问卷成功地从纸质版改编到电子版，并且在迁移过程中仅对内容和格式进行了一些修改。大多数评论都与技术有关，例如触摸功能和复选框。两项问卷的跨文化翻译都令人满意，只需要进行一些小的改写。
VEINES-QoL/Sym 和 PEmb-QoL 的原始和丹麦版本已成功改编为电子版，可供 REDCap 用户共享。此外，这两个问卷的丹麦版本都表现出了令人满意的表面有效性。
