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Table 1 Outcomes included in COS for research for T2D (SCORE-IT), COS for routine care (ICHOM set), EMA, FDA and NICE guidelines, NICE QS and QI, CPRD and DECIDE trial

From: Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus

SCORE-IT COSICHOM setGuidelinesNICE QSNICE QICPRDDECIDESCORE-IT core outcome not explicitly mentioned but covered by the following general terms
EMAFDANICE
Overall survival      
Death from a diabetes related cause such as heart disease ()a  aCardiovascular disease/safety profile
Heart failure()ab()ac() c aCardiovascular disease/safety profile bCoronary complications cDiabetes-related complications
Gangrene or amputation of the leg, foot or toe()d()c dPeripheral vascular diseases cDiabetes-related complications
Hyperglycaemic emergencies1 ()c() c cDiabetes-related complications
Hyperglycaemia  ()c() c cDiabetes-related complications
Hypoglycaemia4()c() ccDiabetes-related complications
Cerebrovascular disease()c()c cDiabetes-related complications
Hospital admissions due to diabetes  efe Health economic modelling of the T2D guideline may use estimates on admission rates from sources such as CPRD or HES. f Mentioned only in relation to type 1 diabetes
Side effects of treatment   
Global quality of life   
Nonfatal myocardial infarction()ab()ac()c aCardiovascular disease/safety profile bCoronary complications cDiabetes-related complications
Visual deterioration or blindness()g()c()c cDiabetes-related complications gRetinopathy
Glycaemic control4 
Neuropathy2()c()c cDiabetes-related complications
Kidney function()c()ccDiabetes-related complications
Activities of daily living3  h  hActivities of daily living are captured in the quality of life measure used by NICE to inform impact on QALYs
Body weight4  ()ii BMI
  1. BMI body mass index, COS core outcomes set, CRPD Clinical Practice Research Datalink, EMA European Medicines Agency, FDA U.S. Food and Drug Administration, HES Hospital episode statistics, NICE National Institute for Health and Care Excellence, QALY quality-adjusted life-year, QI quality indicator, QS quality standard, T2D type 2 diabetes
  2. 1 Including diabetic ketoacidosis and hyperosmolar hyperglycaemic state 2 Damage to the nerves caused by high glucose. This can lead to tingling and pain or numbness in the feet or legs. It can also affect bowel control; stomach emptying and sexual function. 3 Including those related to personal care; household tasks or community-based tasks. 4 Included as core efficacy or safety outcome