Development and Validation of the Diabetes Pen Experience Measure: A New Patient-Reported Outcome Measure
Authors' conclusion
The evidence presented supports the use of the DPEM in clinical trials to evaluate the patients' experience with diabetes injection devices.
Study context
- Population
- Patients using diabetes injection (pen) devicesvalidation study
- Participants
- 300 patients
- Outcome
- Psychometric properties of the DPEM
Methodological detailsliterature review, concept elicitation interviews, cognitive debriefing, web-based noninterventional validation survey, psychometric analyses per statistical analysis plan
- Literature review
- Concept elicitation interviews
- Cognitive debriefing
- Web-based noninterventional validation survey
- Psychometric analyses per statistical analysis plan
Performance
As reported in the abstract
Item-to-total correlations
0.68 to 0.79
Internal consistency, Cronbach's alpha
0.91
Final number of higher-order items (reduced from 28 owing to ceiling/floor effects)
7
Further findings
Measure development
- Patients in concept elicitation interviews
- 42
- Items in preliminary Diabetes Pen Experience Measure (DPEM)
- 30
- Items in validation-ready version after cognitive debriefing
- 28
- Scoring: sum of 7 item scores transformed onto a 100-point scale
Original publication
Development and Validation of the Diabetes Pen Experience Measure: A New Patient-Reported Outcome Measure. J Diabetes Sci Technol. Published 14 March 2022. doi:10.
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