Abstract
BackgroundAlong with general measures of treatment satisfaction, treatment-specific and device-specific treatment satisfaction should be assessed in clinical trials, because these latter measures may be more strongly correlated with clinical outcomes.MethodsStudy participants were 1076 adults (type 1 = 509, type 2 = 567) in clinical trials of Technosphere Insulin®, who completed the SF-36 health-related quality of life questionnaire and the Inhaled Insulin Treatment Questionnaire (IITQ), a new instrument assessing diabetes worries, perceptions of insulin therapy, treatment satisfaction, treatment preference, and inhaler performance. The IITQ was administered twice prior to treatment initiation in the clinical trials, 1-2 weeks apart, and several times during the trials. Inhaler performance was assessed at follow-up visits, after participants had used the device.ResultsIITQ subscales had acceptable reliability (alpha = 0.68-0.87, median 0.83) and test-retest correlations (intra-class correlation coefficient = 0.67-0.90, median 0.82); floor effects (0.2-2.8%) and ceiling effects (0-9.3%) were minimal. Reliabilities for inhaler performance measures were acceptable (alpha = 0.73-0.90, median 0.85); there were no floor effects (0.0%) and ceiling effects (4.9-39.0%) were moderate. There were several modest associations between IITQ scores and measures of health status. Diabetes worries were lower for participants who had better mental health (type 2) and for those with higher BMI; perceptions of insulin therapy were more favorable for participants who had better physical and mental health; treatment satisfaction was higher for patients who had lower BMI (type 2), lower A1c levels, and better physical health (type 2); treatment preference was higher for patients with lower BMI (type 2) and better mental health (type 1).Conclusions -Preliminary findings suggest that the IITQ is a comprehensive, reliable measure of the experience of patients treated with inhaled insulin.
Highlights
Along with general measures of treatment satisfaction, treatment-specific and device-specific treatment satisfaction should be assessed in clinical trials, because these latter measures may be more strongly correlated with clinical outcomes
A question such as “how much does your insulin delivery system interfere with your ability to get a good night’s sleep?”, is likely to be more sensitive to differences among insulin delivery systems than a question such as “how satisfied are you with your understanding of diabetes? [8]
The results of this study provide evidence that the Insulin Treatment Questionnaire (IITQ) is a reliable instrument for assessing a broad range of patient reported outcomes (PRO) in patients with type 1 or type 2 diabetes using inhaled insulin
Summary
Along with general measures of treatment satisfaction, treatment-specific and device-specific treatment satisfaction should be assessed in clinical trials, because these latter measures may be more strongly correlated with clinical outcomes. A comprehensive assessment of PRO should include measures of general concerns (e.g., diabetes-related worries), treatment-specific measures (e.g., perceptions of insulin therapy), and treatment satisfaction and treatment preference, as well as device-specific measures when applicable (e.g., insulin delivery system perceptions). Comprehensive diabetes treatment satisfaction instruments include the Insulin Delivery System Rating Questionnaire (IDSRQ) [5] and the Pramlintide Treatment Satisfaction Questionnaire (PRAM-TSQ) [6]. Treatment-specific and device-specific measures should be included in assessment instruments because they may be more strongly correlated with clinical outcomes than more general diabetes treatment satisfaction measures [7]. A question such as “how much does your insulin delivery system interfere with your ability to get a good night’s sleep?” (from the IDSRQ), is likely to be more sensitive to differences among insulin delivery systems than a question such as “how satisfied are you with your understanding of diabetes? (from the Diabetes Treatment Satisfaction Questionnaire) [8]
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