Department of Surgery, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, The Netherlands.
Department of Clinical Epidemiology and Medical Technology Assessment, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Maastricht, The Netherlands.
Colorectal Dis. 2023 Aug;25(8):1671-1678. doi: 10.1111/codi.16650. Epub 2023 Jul 11.
The aim of this study was to translate the Dutch patient-reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS) to English and perform a cross-cultural validation.
The ISPOR good practice guidelines for the cross-cultural validation of PROMs were followed and included two steps: (1) Two forward and two backward translations. The forward translation concerned the translation from the source language (Dutch) to the target language (English), performed by two independent English speakers, one medical doctor and one nonmedical. Subsequently, a discussion about discrepancies in the reconciled version was performed by a stakeholder group. (2) Cognitive interviews were held with patients with haemorrhoidal disease (HD), probing the comprehensibility and comprehensiveness of the PROM-HISS.
Discrepancies in the reconciled forward translation concerned the terminology of HD symptoms. Furthermore, special attention was paid to the response options, ranging from "not at all", indicating minor symptoms, to "a lot", implying many symptoms. Consensus among the stakeholder group about the final version of the translated PROM-HISS was reached. Interviews were conducted with 10 native English-speaking HD patients (30% female), with a mean age of 44 years (24-83) and primarily diagnosed with grade II HD (80%). The mean time to complete the PROM-HISS was 1 min 43 s. Patients showed a good understanding of the questions and response options, found all items relevant and did not miss important symptoms or topics.
The translated English language PROM-HISS is a valid tool to assess symptoms of HD, its impact on daily activities and patient satisfaction with HD treatment.
本研究旨在将荷兰患者报告结局测量-痔病影响和满意度评分（PROM-HISS）翻译为英文，并进行跨文化验证。
遵循 ISPOR 患者报告结局测量跨文化验证良好实践指南，包括两个步骤：（1）正向和反向翻译各两次。正向翻译涉及从源语言（荷兰语）到目标语言（英语）的翻译，由两名独立的英语使用者进行，一名是医生，另一名是非医学专业人士。随后，由利益相关者小组对协调后的版本中的差异进行讨论。（2）对痔病患者进行认知访谈，探查 PROM-HISS 的可理解性和全面性。
协调后的正向翻译中的差异涉及痔病症状的术语。此外，特别关注了从“一点也不”（表示症状轻微）到“很多”（表示症状很多）的反应选项。利益相关者小组就翻译后的 PROM-HISS 最终版本达成共识。对 10 名母语为英语的痔病患者（女性占 30%）进行了访谈，平均年龄为 44 岁（24-83 岁），主要诊断为 II 度痔病（80%）。完成 PROM-HISS 的平均时间为 1 分 43 秒。患者对问题和反应选项有很好的理解，认为所有项目都相关，没有遗漏重要的症状或主题。
翻译后的英语 PROM-HISS 是评估痔病症状、对日常活动的影响以及患者对痔病治疗满意度的有效工具。
