hendrieckx-coreoutcomesset-2017.pdf (978.75 kB)
A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes: an international, multi-perspective Delphi consensus study
journal contribution
posted on 2017-12-19, 00:00 authored by M Byrne, A O'Connell, A M Egan, S F Dinneen, L Hynes, M C O'Hara, R I G Holt, I Willaing, M Vallis, Christel HendrieckxChristel Hendrieckx, I CoyneBACKGROUND: 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.
History
Journal
TrialsVolume
18Article number
602Pagination
1 - 8Publisher
BioMed CentralLocation
London, Eng.Publisher DOI
Link to full text
eISSN
1745-6215Language
engPublication classification
C Journal article; C1 Refereed article in a scholarly journalCopyright notice
2017, The AuthorsUsage metrics
Categories
No categories selectedKeywords
Licence
Exports
RefWorks
BibTeX
Ref. manager
Endnote
DataCite
NLM
DC