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A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes: an international, multi-perspective Delphi consensus study

Byrne, Molly, O'Connell, Anthony, Egan, Aoife M, Dinneen, Sean F, Hynes, Lisa, O'Hara, Mary Clare, Holt, Richard IG, Willaing, Ingrid, Vallis, Michael, Hendrieckx, Christel and Coyne, Imelda 2017, A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes: an international, multi-perspective Delphi consensus study, Trials, vol. 18, pp. 1-8, doi: 10.1186/s13063-017-2364-y.

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Title A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes: an international, multi-perspective Delphi consensus study
Author(s) Byrne, Molly
O'Connell, Anthony
Egan, Aoife M
Dinneen, Sean F
Hynes, Lisa
O'Hara, Mary Clare
Holt, Richard IG
Willaing, Ingrid
Vallis, Michael
Hendrieckx, ChristelORCID iD for Hendrieckx, Christel orcid.org/0000-0002-0075-828X
Coyne, Imelda
Journal name Trials
Volume number 18
Article ID 602
Start page 1
End page 8
Total pages 8
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2017-12-19
ISSN 1745-6215
Keyword(s) clinical diabetes
core outcome set
healthcare delivery
interventions
randomised controlled trials
self-management
Type 1 diabetes
young adults
science & technology
life sciences & biomedicine
medicine, research & experimental
research & experimental medicine
people
care
Summary BACKGROUND: Achieving consensus from a range of relevant stakeholders about an agreed set of core outcomes to be measured and reported as a minimum in clinical trials has the potential to enhance evidence synthesis and make findings more relevant and applicable. Intervention research to improve outcomes for young adults with type 1 diabetes (T1DM) is hampered by inconsistent use of outcome measures. This population frequently struggles to manage their condition and reports suboptimal clinical outcomes. Our aim was to conduct an international, e-Delphi consensus study to identify a core outcome set (COS) that key stakeholders (young adults with T1DM, diabetes health professionals, diabetes researchers and diabetes policy makers) consider as essential outcomes for future intervention research.

METHODS: Using a list of 87 outcomes generated from a published systematic review, we administered two online surveys to a sample of international key stakeholders. Participants in the first survey (survey 1; n = 132) and the second survey (survey 2; n = 81) rated the importance of the outcomes. Survey 2 participants received information on total mean rating for each outcome and a reminder of their personal outcome ratings from Survey 1. Survey 2 results were discussed at a consensus meeting and participants (n = 12: three young adults with T1DM, four diabetes health professionals, four diabetes researchers and one diabetes policy maker) voted on outcomes. Final core outcomes were included provided that 70% of consensus group participants voted for their inclusion.

RESULTS: Eight core outcomes were agreed for inclusion in the final COS: measures of diabetes-related stress; diabetes-related quality of life; number of severe hypoglycaemic events; self-management behaviour; number of instances of diabetic ketoacidosis (DKA); objectively measured glycated haemoglobin (HbA1C); level of clinic engagement; and perceived level of control over diabetes.

CONCLUSIONS: This study is the first to identify a COS for inclusion in future intervention trials to improve outcomes for young adults with T1DM. Use of this COS will improve the quality of future research and increase opportunities for evidence synthesis. Future research is necessary to identify the most robust outcome measure instruments.
Language eng
DOI 10.1186/s13063-017-2364-y
Field of Research 1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2017, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30108797

Document type: Journal Article
Collections: School of Psychology
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.