Methods for conducting international Delphi surveys to optimise global participation in core outcome set development: a case study in gastric cancer informed by a comprehensive literature review.


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
21 Jun 2021
Historique:
received: 07 12 2020
accepted: 21 05 2021
entrez: 22 6 2021
pubmed: 23 6 2021
medline: 24 6 2021
Statut: epublish

Résumé

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.

Sections du résumé

BACKGROUND 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 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 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 CONCLUSIONS
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.

Identifiants

pubmed: 34154641
doi: 10.1186/s13063-021-05338-x
pii: 10.1186/s13063-021-05338-x
pmc: PMC8218463
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

410

Subventions

Organisme : Department of Health
ID : DRF-2015-08-023
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/K025643/1
Pays : United Kingdom
Organisme : National Institute for Health Research
ID : DRF-2015-08-023

Investigateurs

Shuangxi Li (S)
Yu-Long He (YL)
Zekuan Xu (Z)
Yingwei Xue (Y)
Han Liang (H)
Guoxin Li (G)
Enhao Zhao (E)
Philipp Neumann (P)
Linda O'Neill (L)
Emer Guinan (E)
Gian Luca Baiocchi (GL)
Giovanni de Manzoni (G)
Eliza R C Hagens (ERC)
Mark I van Berge Henegouwen (MI)
Patrícia Lages (P)
Susana Onofre (S)
Gabriel Salcedo Cabañas (GS)
Maria Posada Gonzalez (MP)
Cristina Marin Campos (CM)
Bahar Candas (B)
Bahadır Emre Baki (BE)
Muhammed Selim Bodur (MS)
Reyyan Yildirim (R)
Arif Burak Cekic (AB)
Jean-Baptiste Beuscart (JB)
Sophie Horbach (S)
Christopher Mecoli (C)
Toby O Smith (TO)

Références

Gastric Cancer. 2019 Jan;22(1):172-189
pubmed: 29846827
Lancet Gastroenterol Hepatol. 2018 Dec;3(12):865-873
pubmed: 30507470
BMJ Open. 2018 Oct 17;8(10):e021796
pubmed: 30337308
Expert Rev Pharmacoecon Outcomes Res. 2017 Dec;17(6):523-530
pubmed: 28974101
Trials. 2017 Jun 20;18(Suppl 3):280
pubmed: 28681707
J Clin Epidemiol. 2018 Apr;96:84-92
pubmed: 29288712
Implement Sci. 2018 May 29;13(1):72
pubmed: 29843737
Br J Dermatol. 2018 Feb;178(2):473-481
pubmed: 28986976
PLoS One. 2018 Dec 28;13(12):e0209869
pubmed: 30592741
Value Health. 2005 Mar-Apr;8(2):94-104
pubmed: 15804318
BMC Med. 2018 Feb 13;16(1):21
pubmed: 29433501
J Rheumatol. 2019 Aug;46(8):981-989
pubmed: 30647185
BMJ Open. 2020 Feb 12;10(2):e034782
pubmed: 32051319
J Rheumatol. 2017 Nov;44(11):1683-1687
pubmed: 28765245
Trials. 2017 Aug 9;18(1):370
pubmed: 28793921

Auteurs

Bilal Alkhaffaf (B)

Department of Oesophago-Gastric Surgery, Salford Royal Hospital, Salford Royal NHS Foundation Trust, Stott Lane, Manchester, M6 8HD, UK. bilal.alkhaffaf@srft.nhs.uk.
Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK. bilal.alkhaffaf@srft.nhs.uk.

Jane M Blazeby (JM)

Centre for Surgical Research and Bristol and Weston NIHR Biomedical Research Centre, University of Bristol, Bristol, UK.

Aleksandra Metryka (A)

Paediatric ENT Department, Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust, Manchester, UK.

Anne-Marie Glenny (AM)

Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

Ademola Adeyeye (A)

University of Ilorin Teaching Hospital, Ilorin, Nigeria.

Paulo Matos Costa (PM)

Hospital Garcia de Orta, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.

Ismael Diez Del Val (ID)

Basurto University Hospital, Bilbao, Spain.

Suzanne S Gisbertz (SS)

Department of Surgery, Cancer Center, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Ali Guner (A)

Department of General Surgery, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.

Simon Law (S)

Department of Surgery, The University of Hong Kong, Hong Kong, China.

Hyuk-Joon Lee (HJ)

Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.

Ziyu Li (Z)

Peking University Cancer Hospital and Institute, Beijing, China.

Koji Nakada (K)

Department of Laboratory Medicine, The Jikei University Daisan Hospital, Komae, Japan.

Rafael Mauricio Restrepo Nuñez (RMR)

Hospital Universitario Rey Juan Carlos, Mostoles, Spain.

Daniel Reim (D)

Department of Surgery, TUM School of Medicine, Munich, Germany.

John V Reynolds (JV)

Department of Surgery, Trinity Translational Medicine Institute and St James's Hospital, Dublin, Ireland.

Peter Vorwald (P)

Hospital Universitario Fundación Jiménez Diaz, Madrid, Spain.

Daniela Zanotti (D)

Regional Centre for Oesophago-gastric Surgery, Broomfield Hospital, Chelmsford, UK.

William Allum (W)

Department of Academic Surgery, Royal Marsden NHS Foundation Trust, London, UK.

M Asif Chaudry (MA)

Department of Academic Surgery, Royal Marsden NHS Foundation Trust, London, UK.

Ewen Griffiths (E)

Upper GI Unit, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Birmingham, UK.

Paula R Williamson (PR)

MRC North West Hub for Trials Methodology Research, University of Liverpool and a member of Liverpool Health Partners, Liverpool, UK.

Iain A Bruce (IA)

Division of Infection, Immunity and Respiratory Medicine, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

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Classifications MeSH