Objective: Diabetes is a common, debilitating chronic illness with multiple impacts. The impact on treatment satisfaction, productivity
impairment and the symptom experience may be among the most important for patient-reported outcomes. This study developed
and validated disease-specific, patient-reported measures for these outcomes that address limitations in currently available
measures.
Methods: Data was collected from the literature, experts and patients and a conceptual model of the patient-reported impact of diabetes
was created. Item pools, based on the conceptual model, were then generated. The items were administered to 991 diabetes patients
via a web-based survey to perform item reduction, identify relevant factor structures and assess reliability and validity
following an
a-priori analysis plan.
Results: All validation criteria and hypotheses were met resulting in three new, valid measures: a 21-item Satisfaction Measure (three
sub-scales: burden, efficacy and symptoms), a 30-item Symptom Measure and a 14-item Productivity Measure assessing both life
and work productivity impairments.
Conclusion: This triad of measures captures important components of the multifaceted diabetes patient experience and can be considered
as valid, viable options when choosing measures to assess patient-reported outcomes. Addressing these outcomes may assist
researchers and clinicians to develop more patient-centered diabetes interventions and care.
Keywords Diabetes - Patient-reported outcomes - Productivity - Symptoms - Treatment satisfaction