All statistical analyses were performed using SAS® version 9.2 statistical software. A utility value was assigned to each health state based on each individual response, derived from the midpoint of the indifference interval derived as described above. The average utility value was calculated for each health state, and a disutility per hypoglycaemic event derived by dividing the difference between the average utility and the baseline diabetes state utility by the number of annual events, to ensure that the resulting value reflected the effect of hypoglycaemia alone.
For each hypoglycaemic event class, up to four different event frequencies (health states) were evaluated (Additional file 2: Table S2). Unit values per hypoglycaemic incident type were calculated from the average TTO value for each frequency, weighted according to the distribution of those specific hypoglycaemic event frequencies among the participants with diabetes.
Statistical results for the type 1 and type 2 diabetes populations contain combined data from any general population respondents with type 1 or type 2 diabetes and data from the respective type 1 or type 2 diabetes populations.
As the response distribution was unknown but suspected to be non-normal, non-parametric bootstrapping was used to simulate standard errors and confidence intervals (CIs) for the mean TTO values. This method estimates the parameter’s distribution by repeatedly resampling the original data set with replacement [37 (link)-39 (link)]. For the present study, 10,000 iterations were performed.
Because it is rare for a patient with diabetes to experience severe hypoglycaemic events without non-severe events, some of the worries and limits to daily activities may already be accounted for by the disutility associated with non-severe events. Therefore, the initial disutility value (determined as the intercept in a regression model) for non-severe hypoglycaemic events was subtracted from the value obtained for severe hypoglycaemic events.
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