TABLE 1.
Outcomes | Importance a | Cut‐off point for clinical relevance | MCID based on |
---|---|---|---|
All‐cause mortality | critical | RRR 10% (RR <0,9 or RR >1,1) | Expert opinion guideline committee |
Macrovascular morbidity | critical | RRR 25% (RR <0,75 of RR >1,25) | GRADE 13 |
Microvascular morbidity | critical | RRR 25% (RR <0,75 or RR >1,25) | GRADE 13 |
Quality of life | critical | every statistically significant difference or SMD = 0,5 | GRADE 13 |
Severe hypoglycemia | critical | RRR 25% (RR <0,75 of RR >1,25) | GRADE 13 |
Other adverse events | critical or important b | every statistically significant difference or SMD = 0,5 | GRADE 13 |
Hospital admissions | important | RRR 25% (RR <0,75 of RR >1,25) | GRADE 13 |
Change in HbA1c | important | 0,5% or 5 mmol/mol | NICE guideline Type 2 diabetes in adults: management 11 |
Change in body weight | important |
5% in case of both treatments cause weight gain 2,5% in case of one treatment causes weight loss and the other causes weight gain (or had a neutral effect on weight) |
Dutch guideline T2DM in secondary care 12 |
Other hypoglycemia (not specified or mild or modest) | important | RRR 25% (RR <0,75 of RR >1,25) | GRADE 13 |
Abbreviations: RRR, relative risk reduction; RR, relative risk; SMD, standardized mean difference.
Minor differences existed in relative importance between different healthcare questions. The importance shown is based on the importance for most healthcare questions.
Depending on the severity of the adverse event.