Department of Oesophago-Gastric Surgery, Salford Royal Hospital, Salford Royal NHS Foundation Trust, Stott Lane, Manchester, M6 8HD, UK.
Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Trials. 2021 Jun 21;22(1):410. doi: 10.1186/s13063-021-05338-x.
Core outcome sets (COS) should be relevant to key stakeholders and widely applicable and usable. Ideally, they are developed for international use to allow optimal data synthesis from trials. Electronic Delphi surveys are commonly used to facilitate global participation; however, this has limitations. It is common for these surveys to be conducted in a single language potentially excluding those not fluent in that tongue. The aim of this study is to summarise current approaches for optimising international participation in Delphi studies and make recommendations for future practice.
A comprehensive literature review of current approaches to translating Delphi surveys for COS development was undertaken. A standardised methodology adapted from international guidance derived from 12 major sets of translation guidelines in the field of outcome reporting was developed. As a case study, this was applied to a COS project for surgical trials in gastric cancer to translate a Delphi survey into 7 target languages from regions active in gastric cancer research.
Three hundred thirty-two abstracts were screened and four studies addressing COS development in rheumatoid and osteoarthritis, vascular malformations and polypharmacy were eligible for inclusion. There was wide variation in methodological approaches to translation, including the number of forward translations, the inclusion of back translation, the employment of cognitive debriefing and how discrepancies and disagreements were handled. Important considerations were identified during the development of the gastric cancer survey including establishing translation groups, timelines, understanding financial implications, strategies to maximise recruitment and regulatory approvals. The methodological approach to translating the Delphi surveys was easily reproducible by local collaborators and resulted in an additional 637 participants to the 315 recruited to complete the source language survey. Ninety-nine per cent of patients and 97% of healthcare professionals from non-English-speaking regions used translated surveys.
Consideration of the issues described will improve planning by other COS developers and can be used to widen international participation from both patients and healthcare professionals.
核心结局集(COS)应与主要利益相关者相关,且具有广泛的适用性和实用性。理想情况下,COS 应针对国际使用进行开发,以允许从试验中进行最佳的数据综合。电子德尔菲调查常用于促进全球参与;然而,这存在局限性。这些调查通常仅以一种语言进行,可能会排除那些不精通该语言的人。本研究旨在总结当前优化德尔菲研究国际参与的方法,并为未来的实践提出建议。
对用于开发 COS 的德尔菲调查的翻译方法进行了全面的文献回顾。根据国际指导原则,从 12 个主要的结局报告翻译指南中得出了一种标准化的方法。作为案例研究,将其应用于胃外科试验的 COS 项目,将德尔菲调查翻译成来自胃研究活跃地区的 7 种目标语言。
筛选了 332 篇摘要,有 4 项关于类风湿关节炎和骨关节炎、血管畸形和多药治疗的 COS 开发的研究符合纳入标准。翻译方法在方法上存在广泛差异,包括正向翻译的数量、反向翻译的纳入、认知审查的使用以及如何处理差异和分歧。在开发胃癌调查中确定了一些重要的考虑因素,包括建立翻译小组、时间表、了解财务影响、最大限度地招募和监管批准的策略。德尔菲调查翻译的方法学方法很容易被当地合作者复制,从而使源语调查的参与者增加了 637 人,共招募了 315 人。来自非英语地区的 99%的患者和 97%的医疗保健专业人员使用了翻译后的调查问卷。
考虑到所描述的问题,将有助于其他 COS 开发人员的计划,并可用于扩大来自患者和医疗保健专业人员的国际参与。