Alignment between outcomes and minimal clinically important differences in the Dutch type 2 diabetes mellitus guideline and healthcare professionals’ preferences

Abstract

To evaluate the clinical benefit of new medicines for type 2 diabetes mellitus (T2DM), the Dutch guideline committee T2DM in primary care established the importance of outcomes and minimal clinically important differences (MCIDs). The present study used an online questionnaire to investigate healthcare professionals’ opinions about the importance of outcomes and preferences for MCIDs. A total of 211 physicians, pharmacists, practice nurses, diabetes nurses, nurse practitioners and physician assistants evaluated the importance of mortality, macro‐ and microvascular morbidity, HbA1c, body weight, quality of life, (overall) hospital admissions and severe and other hypoglycemia on a 9‐point scale. All outcomes were considered critical (mean scores 7–9), except for body weight and other hypoglycemia (mean scores 4–6). Only HbA1c and hospital admissions were valued differently by the guideline committee (not critical). Other relevant outcomes according to the respondents were adverse events, ease of use and costs. Median MCIDs were 4 mmol/mol for HbA1c (guideline: 5 mmol/mol) and 3 kg for body weight (guideline: 5 kg weight gain and 2,5 kg weight loss). Healthcare professionals preferred relative risk reductions of 20% for mortality (guideline: 10%) and macrovascular morbidity (guideline: 25%) and 50% for other hypoglycaemia (guideline: 25%). The MCID of 25% for microvascular morbidity, hospital admissions and severe hypoglycaemia corresponded to the guideline‐MCID. Healthcare professionals’ preferences were thus comparable to the views of the guideline committee. However, healthcare professionals had a stricter view on the importance of HbA1c and hospital admissions and the MCIDs for mortality and other hypoglycemia.

Structured Diabetes Education: virtual access was as effective as face-to-face access to a structured diabetes education programme (EMPOWER T2n) for people with type 2 diabetes in England

“…The aggregated reduction in HbA1c across both groups was 10.2mmol/mol. This reduction was more than twice the minimum clinically important difference designated for new medicines to reduce HbA1c 3 . The HbA1c reductions found in both interventions were what would be considered to be effective.…”

Effects of a School-Based Nutrition, Gardening, and Cooking Intervention on Metabolic Parameters in High-risk Youth

“…Another limitation is that the improvement in HbA 1c was rather small, albeit significant, and may not be clinically relevant. However, health care professionals believe that even small reductions in HbA 1c levels reflect clinical improvements in glucose control . Another limitation is that the schools selected were a majority Hispanic and low income, and the results of this school-based intervention may not be generalizable to other populations.…”

“…However, health care professionals believe that even small reductions in HbA 1c levels reflect clinical improvements in glucose control. 44 Another limitation is that the schools selected were a majority Hispanic and low income, and the results of this school-based intervention may not be generalizable to other populations. However, given that low-income and Hispanic children are at higher risk of obesity and related metabolic diseases, having cluster RCTs targeting health improvements in schools serving children from low-income and minoritized groups are warranted.…”

10 Years of AMNOG: What is the Willingness-to-Pay for Pharmaceuticals in Germany?

“…When comparing the WTP for new drugs to treat each of the three indications, it should be noted that there are different perceptions of what an important change might be for each outcome. For example, a change in HbA1c is considered to be clinically important if it has a value greater than 0.5% or 5 mmol/mol [ 33 , 34 ]. For diabetes, this would mean that our WTP of €33,814.08 for a 1 percentage point HbA1c reduction would translate to a WTP of €16,907.04 for a clinically important change (i.e., 0.5% point reduction in HbA1c).…”