Department of Pediatrics, Institute of Clinical Sciences, University of Gothenburg, 416 85 Gothenburg, Sweden.
Department of Pediatric Surgery, Sahlgrenska University Hospital, Queen Silvia Children's Hospital, 416 85 Gothenburg, Sweden.
Int J Environ Res Public Health. 2024 May 15;21(5):624. doi: 10.3390/ijerph21050624.
Spina bifida includes a spectrum of different neural tube defects. Myelomeningocele is the most serious type and is associated with a risk of paralysis and sensory dysfunction below the affected level, bladder/bowel dysfunction, brain dysmorphology, and impaired health-related quality of life (HRQoL). The aim of this study was to describe the establishment of linguistic, content and face validity of the Swedish version of a Quality-of-Life Assessment for children (QUALAS-C, = 10 items), teenagers (QUALAS-T, = 10 items) and adults with spina bifida (QUALAS-A, = 15 items) based on the original US English versions. The process included close collaboration with the original instrument developer and complied with international standards on patient-reported outcome measurements. The procedure includes forward translation, expert and patient/parent review and reconciliation, back translation, back translation review and cognitive debriefing interviews with 16 people with spina bifida aged 8 to 33, providing them with the possibility of evaluating the clarity, adequacy, and comprehensiveness of QUALAS-C, QUALAS-T and QUALAS-A, respectively. The interviews lasted a median of 15 min (range 8-16) for QUALAS-C, 10 min (range 9-15) for QUALAS-T and 24 min (range 9-38) for QUALAS-A. Four main issues/topics needed attention and discussion after both the forward and back translation. Following the back translation review, all issues were resolved. The patient feedback revealed recognition of the HRQoL issues included in QUALAS, and also difficulties in understanding some questions. After the patients' evaluation, four items were reworded for clarity. No study participant reported a wish to add to or remove questions from QUALAS. Hence, the Swedish versions of QUALAS became conceptually equivalent to the original US English versions and achieved linguistic, content and face validity. While empowering the voices of people with spina bifida, these results also enable their HRQoL to be properly assessed in research and clinical care in Sweden and in international studies.
脊柱裂包括一系列不同的神经管缺陷。脊膜脊髓膨出是最严重的类型，与受影响水平以下的瘫痪和感觉功能障碍、膀胱/肠道功能障碍、脑畸形和健康相关生活质量受损（HRQoL）的风险相关。本研究旨在描述根据原始美国英语版本，对瑞典语版儿童（QUALAS-C，=10 项）、青少年（QUALAS-T，=10 项）和成人脊柱裂患者（QUALAS-A，=15 项）生活质量评估的语言、内容和表面有效性的建立过程。该过程包括与原始仪器开发者的密切合作，并符合患者报告结果测量的国际标准。该程序包括正向翻译、专家和患者/家长审查与协调、反向翻译、反向翻译审查以及对 16 名年龄在 8 至 33 岁的脊柱裂患者进行认知访谈，分别为他们提供评估 QUALAS-C、QUALAS-T 和 QUALAS-A 的清晰度、充分性和全面性的可能性。访谈时间中位数为 15 分钟（范围 8-16 分钟）用于 QUALAS-C，10 分钟（范围 9-15 分钟）用于 QUALAS-T，24 分钟（范围 9-38 分钟）用于 QUALAS-A。正向和反向翻译后，有四个主要问题/主题需要关注和讨论。在反向翻译审查后，所有问题都得到了解决。患者反馈认可了 QUALAS 中包含的 HRQoL 问题，但也对一些问题的理解存在困难。在患者评估后，为了清晰起见，重新措辞了四个项目。没有研究参与者表示希望从 QUALAS 中添加或删除问题。因此，瑞典语版 QUALAS 在概念上与原始美国英语版本相当，并具有语言、内容和表面有效性。在赋予脊柱裂患者话语权的同时，这些结果也使他们的 HRQoL 能够在瑞典和国际研究中的研究和临床护理中得到适当评估。
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