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 COS | ICHOM set | Guidelines | NICE QS | NICE QI | CPRD | DECIDE | SCORE-IT core outcome not explicitly mentioned but covered by the following general terms | ||
|---|---|---|---|---|---|---|---|---|---|
EMA | FDA | NICE | |||||||
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 | |||
Hypoglycaemia | ✓ | ✓4 | (✓)c | ✓ | (✓) c | ✓ | ✓ | ✓ | cDiabetes-related complications |
Cerebrovascular disease | ✓ | ✓ | (✓)c | ✓ | (✓)c | ✓ | ✓ | cDiabetes-related complications | |
Hospital admissions due to diabetes | ✓ | e | f | ✓ | ✓ | ✓ | e 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 control | ✓ | ✓4 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Neuropathy2 | ✓ | ✓ | (✓)c | ✓ | (✓)c | ✓ | ✓ | cDiabetes-related complications | |
Kidney function | ✓ | ✓ | (✓)c | ✓ | (✓)c | ✓ | ✓ | ✓ | cDiabetes-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 weight | ✓ | ✓4 | ✓ | (✓)i | ✓ | ✓ | i BMI | ||