Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes (SCORE- IT): A patient and healthcare professional consensus on a core outcome set for type 2 diabetes
Objectives
Heterogeneity in outcomes measured across trials of glucose-lowering
interventions for people with type 2 diabetes impacts on the ability to
compare findings and may mean that the results have little importance to
healthcare professionals and the patients that they care for. The
SCORE-IT study (Selecting Core Outcomes for Randomised Effectiveness
trials In Type 2 diabetes) has addressed this issue by establishing
consensus on the most important outcomes for non-surgical interventions
for hyperglycemia in type 2 diabetes.Research design and methods
A comprehensive list of outcomes was developed from registered clinical
trials, online patient resources, qualitative literature and long-term
studies in the field. This list was then scored in a two-round online
Delphi survey completed by healthcare professionals, people with type 2
diabetes, researchers in the field and healthcare policymakers. The
results of this online Delphi were discussed and ratified at a
face-to-face consensus meeting.Results
173 people completed both rounds of the online survey (116 people with
type 2 diabetes, 37 healthcare professionals, 14 researchers and 6
policymakers), 20 of these attended the consensus meeting (13 people
with type 2 diabetes and 7 healthcare professionals). Consensus was
reached on 18 core outcomes across five domains, which include outcomes
related to diabetes care, quality of life and long-term diabetes-related
complications.Conclusions
Implementation of the core outcome set in future trials will ensure
that outcomes of importance to all stakeholders are measured and
reported, enhancing the relevance of trial findings and facilitating the
comparison of results across trials.