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.
Dr Molly Byrne (Principal Investigator)
Senior Lecturer and Research Leader, Health Behaviour Change Research Group, School of Psychology, National University of Ireland Galway, Ireland. Molly.byrne@nuigalway.ie
Mr Anthony O’Connell, Research Assistant Health Behaviour Change Research Group, School of Psychology, National University of Ireland Galway, Ireland.
Dr Aoife Egan, Specialist Registrar in Endocrinology / Research Fellow,
National University of Ireland Galway, Ireland.
Prof Sean Dinneen, School of Medicine, National University of Ireland Galway, Ireland.
Dr Lisa Hynes, Researcher, Health Behaviour Change Research Group, School of Psychology, National University of Ireland Galway, Ireland.
Prof Richard Holt, Professor in Diabetes and Endocrinology, School of Medicine, University of Southampton, UK
Dr Ingrid Willaing, Research Manager, Patient Education Research
Health Promotion Research, Steno Diabetes Center, Copenhagen, Denmark.
Ass Prof Michael Vallis, Department of Psychology and Neuroscience, Dalhousie University, Halifax, Nova Scotia, Canada
Christel Hendrieckx, Research Fellow, The Australian Centre for Behavioural Research in Diabetes and Deaken University, Melbourne, Australia
Prof Imelda Coyne, Professor of Nursing, School of Nursing, Trinity College Dublin, Ireland.
Lisa Hynes
Disease Category: Endocrine & metabolic
Disease Name: Diabetes mellitus , Type 1 Diabetes
Age Range: 15 - 30
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- Policy makers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
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.