ArticleJournal of diabetes science and technology2023
Development and Validation of the Diabetes Pen Experience Measure: A New Patient-Reported Outcome Measure.
Article in Journal of diabetes science and technology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- User experiences and perceptions on the use of digital health technologies in the management of type 2 diabetes: an integrative systematic review.Frontiers in clinical diabetes and healthcare · 2026Pooled it
- Content Validity of the Hemophilia Device Handling and Preference Assessment Questionnaire - A Cognitive Debrief Study in Patients with Hemophilia and Their Caregivers.Patient preference and adherence · 2025Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSatisfaction with insulin-delivery devices has been shown to improve treatment adherence, translating into better glycemic control. The Diabetes Pen Experience Measure (DPEM) is a new patient-reported outcome measure to evaluate patients' experience when using an injection device.
methodsThe DPEM was developed using literature review and concept elicitation interviews with clinical experts and patients. This led to a theoretical model and a draft measure of the diabetes pen experience, which was refined following cognitive debriefing. Validation entailed a web-based, noninterventional survey; psychometric analyses conducted according to a statistical analysis plan; and refinement and finalization of the DPEM and theoretical model.
resultsIn total, 42 patients participated in concept elicitation interviews. Analysis of the qualitative interviews resulted in a preliminary theoretical model. Based on this model, DPEM items were generated; the preliminary version of the DPEM contained 30 items. Following cognitive debriefing, the validation-ready version comprised 28 items. These were later reduced to 7 higher-order items owing to ceiling/floor effects. In total, 300 patients participated in the web-based validation study. The item statistics were all adequate. Item-to-item correlations were good. Item-to-total correlations displayed acceptable associations between each item against the rest of the items, with correlations of 0.68 to 0.79. The internal consistency was adequate, with a Cronbach's alpha of 0.91. The DPEM is scored by summing the 7 item scores and transforming the sum onto a 100-point scale.
conclusionThe evidence presented supports the use of the DPEM in clinical trials to evaluate the patients' experience with diabetes injection devices.
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Registered trials
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