How are trial outcomes prioritised by stakeholders from different regions? Analysis of an international Delphi survey to develop a core outcome set in gastric cancer surgery.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2021
2021
Historique:
received:
26
12
2020
accepted:
15
12
2021
entrez:
31
12
2021
pubmed:
1
1
2022
medline:
13
1
2022
Statut:
epublish
Résumé
International stakeholder participation is important in the development of core outcome sets (COS). Stakeholders from varying regions may value health outcomes differently. Here, we explore how region, health income and participant characteristics influence prioritisation of outcomes during development of a COS for gastric cancer surgery trials (the GASTROS study). 952 participants from 55 countries participating in a Delphi survey during COS development were eligible for inclusion. Recruits were grouped according to region (East or West), country income classification (high and low-to-middle income) and other characteristics (e.g. patients; age, sex, time since surgery, mode of treatment, surgical approach and healthcare professionals; clinical experience). Groups were compared with respect to how they categorised 56 outcomes identified as potentially important to include in the final COS ('consensus in', 'consensus out', 'no consensus'). Outcomes categorised as 'consensus in' or 'consensus out' by all 3 stakeholder groups would be automatically included in or excluded from the COS respectively. In total, 13 outcomes were categorised 'consensus in' (disease-free survival, disease-specific survival, surgery-related death, recurrence of cancer, completeness of tumour removal, overall quality of life, nutritional effects, all-cause complications, intraoperative complications, anaesthetic complications, anastomotic complications, multiple organ failure, and bleeding), 13 'consensus out' and 31 'no consensus'. There was little variation in prioritisation of outcomes by stakeholders from Eastern or Western countries and high or low-to-middle income countries. There was little variation in outcome prioritisation within either health professional or patient groups. Our study suggests that there is little variation in opinion within stakeholder groups when participant region and other characteristics are considered. This finding may help COS developers when designing their Delphi surveys and recruitment strategies. Further work across other clinical fields is needed before broad recommendations can be made.
Sections du résumé
BACKGROUND
International stakeholder participation is important in the development of core outcome sets (COS). Stakeholders from varying regions may value health outcomes differently. Here, we explore how region, health income and participant characteristics influence prioritisation of outcomes during development of a COS for gastric cancer surgery trials (the GASTROS study).
METHODS
952 participants from 55 countries participating in a Delphi survey during COS development were eligible for inclusion. Recruits were grouped according to region (East or West), country income classification (high and low-to-middle income) and other characteristics (e.g. patients; age, sex, time since surgery, mode of treatment, surgical approach and healthcare professionals; clinical experience). Groups were compared with respect to how they categorised 56 outcomes identified as potentially important to include in the final COS ('consensus in', 'consensus out', 'no consensus'). Outcomes categorised as 'consensus in' or 'consensus out' by all 3 stakeholder groups would be automatically included in or excluded from the COS respectively.
RESULTS
In total, 13 outcomes were categorised 'consensus in' (disease-free survival, disease-specific survival, surgery-related death, recurrence of cancer, completeness of tumour removal, overall quality of life, nutritional effects, all-cause complications, intraoperative complications, anaesthetic complications, anastomotic complications, multiple organ failure, and bleeding), 13 'consensus out' and 31 'no consensus'. There was little variation in prioritisation of outcomes by stakeholders from Eastern or Western countries and high or low-to-middle income countries. There was little variation in outcome prioritisation within either health professional or patient groups.
CONCLUSION
Our study suggests that there is little variation in opinion within stakeholder groups when participant region and other characteristics are considered. This finding may help COS developers when designing their Delphi surveys and recruitment strategies. Further work across other clinical fields is needed before broad recommendations can be made.
Identifiants
pubmed: 34972165
doi: 10.1371/journal.pone.0261937
pii: PONE-D-20-40628
pmc: PMC8719722
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0261937Subventions
Organisme : Medical Research Council
ID : MR/K025643/1
Pays : United Kingdom
Organisme : Department of Health
ID : DRF-2015-08-023
Pays : United Kingdom
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
Trials. 2012 Aug 06;13:132
pubmed: 22867278
J Clin Epidemiol. 2019 Nov;115:90-97
pubmed: 31326541
Eur J Surg Oncol. 2016 Jan;42(1):116-22
pubmed: 26461256
BMJ Open. 2018 Oct 17;8(10):e021796
pubmed: 30337308
BMJ Open. 2020 Feb 12;10(2):e034782
pubmed: 32051319
PLoS One. 2014 Jun 16;9(6):e99111
pubmed: 24932522
Trials. 2017 Jun 20;18(Suppl 3):280
pubmed: 28681707
Trials. 2017 Aug 9;18(1):370
pubmed: 28793921
J Clin Epidemiol. 2018 Apr;96:84-92
pubmed: 29288712
J Clin Epidemiol. 2020 Dec;128:118-129
pubmed: 33011214
BMC Med Res Methodol. 2021 Jan 7;21(1):10
pubmed: 33413129
J Gastrointest Oncol. 2015 Feb;6(1):79-88
pubmed: 25642341
Clin Oncol (R Coll Radiol). 2019 Aug;31(8):570-577
pubmed: 31178345
Obes Surg. 2016 Nov;26(11):2738-2746
pubmed: 27138600
Trials. 2016 Sep 23;17(1):463
pubmed: 27664072
Asia Pac J Clin Oncol. 2014 Mar;10(1):38-52
pubmed: 23937356