Abstract
Background
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.
Methods
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.
Results
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.
Conclusion
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.
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; Blazeby, Jane M. 2 ; Metryka, Aleksandra 3 ; Glenny, Anne-Marie 4 ; Adeyeye, Ademola 5 ; Costa, Paulo Matos 6 ; del Val, Ismael Diez 7 ; Gisbertz, Suzanne S. 8 ; Guner, Ali 9 ; Law, Simon 10 ; Lee, Hyuk-Joon 11 ; Li, Ziyu 12 ; Nakada, Koji 13 ; Nuñez, Rafael Mauricio Restrepo 14 ; Reim, Daniel 15 ; Reynolds, John V. 16 ; Vorwald, Peter 17 ; Zanotti, Daniela 18 ; Allum, William 19 ; Chaudry, M. Asif 19 ; Griffiths, Ewen 20 ; Williamson, Paula R. 21 ; Bruce, Iain A. 22 ; Li, Shuangxi; He, Yu-long; Xu, Zekuan; Xue, Yingwei; Liang, Han; Li, Guoxin; Zhao, Enhao; Neumann, Philipp; O’Neill, Linda; Guinan, Emer; Baiocchi, Gian Luca; de Manzoni, Giovanni; Hagens, Eliza R. C.; van Berge Henegouwen, Mark I.; Lages, Patrícia; Onofre, Susana; Cabañas, Gabriel Salcedo; Gonzalez, Maria Posada; Campos, Cristina Marin; Candas, Bahar; Baki, Bahadır Emre; Bodur, Muhammed Selim; Yildirim, Reyyan; Cekic, Arif Burak; Beuscart, Jean-Baptiste; Horbach, Sophie; Mecoli, Christopher; Smith, Toby O.1 Salford Royal Hospital, Salford Royal NHS Foundation Trust, Department of Oesophago-Gastric Surgery, Manchester, UK (GRID:grid.415721.4) (ISNI:0000 0000 8535 2371); University of Manchester, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester, UK (GRID:grid.5379.8) (ISNI:0000000121662407)
2 University of Bristol, Centre for Surgical Research and Bristol and Weston NIHR Biomedical Research Centre, Bristol, UK (GRID:grid.5337.2) (ISNI:0000 0004 1936 7603)
3 Manchester University NHS Foundation Trust, Paediatric ENT Department, Royal Manchester Children’s Hospital, Manchester, UK (GRID:grid.498924.a)
4 University of Manchester, Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester, UK (GRID:grid.5379.8) (ISNI:0000000121662407)
5 University of Ilorin Teaching Hospital, Ilorin, Nigeria (GRID:grid.412975.c) (ISNI:0000 0000 8878 5287)
6 Faculdade de Medicina da Universidade de Lisboa, Hospital Garcia de Orta, Lisbon, Portugal (GRID:grid.9983.b) (ISNI:0000 0001 2181 4263)
7 Basurto University Hospital, Bilbao, Spain (GRID:grid.414269.c) (ISNI:0000 0001 0667 6181)
8 Amsterdam UMC, University of Amsterdam, Department of Surgery, Cancer Center, Amsterdam, The Netherlands (GRID:grid.7177.6) (ISNI:0000000084992262)
9 Karadeniz Technical University, Department of General Surgery, Faculty of Medicine, Trabzon, Turkey (GRID:grid.31564.35) (ISNI:0000 0001 2186 0630)
10 The University of Hong Kong, Department of Surgery, Hong Kong, China (GRID:grid.194645.b) (ISNI:0000000121742757)
11 Seoul National University College of Medicine, Department of Surgery and Cancer Research Institute, Seoul, South Korea (GRID:grid.31501.36) (ISNI:0000 0004 0470 5905)
12 Peking University Cancer Hospital and Institute, Beijing, China (GRID:grid.412474.0) (ISNI:0000 0001 0027 0586)
13 The Jikei University Daisan Hospital, Department of Laboratory Medicine, Komae, Japan (GRID:grid.411898.d) (ISNI:0000 0001 0661 2073)
14 Hospital Universitario Rey Juan Carlos, Mostoles, Spain (GRID:grid.459654.f)
15 TUM School of Medicine, Department of Surgery, Munich, Germany (GRID:grid.6936.a) (ISNI:0000000123222966)
16 Trinity Translational Medicine Institute and St James’s Hospital, Department of Surgery, Dublin, Ireland (GRID:grid.416409.e) (ISNI:0000 0004 0617 8280)
17 Hospital Universitario Fundación Jiménez Diaz, Madrid, Spain (GRID:grid.419651.e)
18 Broomfield Hospital, Regional Centre for Oesophago-gastric Surgery, Chelmsford, UK (GRID:grid.414650.2) (ISNI:0000 0004 0399 7889)
19 Royal Marsden NHS Foundation Trust, Department of Academic Surgery, London, UK (GRID:grid.5072.0) (ISNI:0000 0001 0304 893X)
20 University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Upper GI Unit, Birmingham, UK (GRID:grid.415490.d) (ISNI:0000 0001 2177 007X)
21 University of Liverpool and a member of Liverpool Health Partners, MRC North West Hub for Trials Methodology Research, Liverpool, UK (GRID:grid.10025.36) (ISNI:0000 0004 1936 8470)
22 University of Manchester, Division of Infection, Immunity and Respiratory Medicine, Faculty of Biology, Medicine and Health, Manchester, UK (GRID:grid.5379.8) (ISNI:0000000121662407)




