caa a22 4500 606178813 CHVBK 20210128100758.0 cr unu---uuuuu 210128e20151201xx s 000 0 eng 10.1007/s11136-015-1037-0 doi (NATIONALLICENCE)springer-10.1007/s11136-015-1037-0 Development and validation of the Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure, a patient-reported outcome measure [Elektronische Daten] [Meryl Brod, Steven Blum, Donald Bushnell, Abhilasha Ramasamy] Purpose: Diabetic peripheral neuropathy (DPN) occurs in 26-47% of diabetes patients and may have negative impacts on physical functioning, sleep, well-being, and quality of life. The Diabetic Peripheral Neuropathic Pain Impact measure (DPNPI) was developed to measure disease impacts and treatment effects. Presented are the DPNPI conceptual development and validation findings. Methods: The DPNPI was developed following the FDA Guidance for Industry on patient-reported outcome (PRO) measures. Concept elicitation (CE) included literature review, clinical expert interviews, and patient interviews/focus groups. Qualitative data were analyzed following grounded theory principles, and draft items were cognitively debriefed. The measure underwent psychometric validation, and an a priori statistical analysis plan assessed the measurement model, reliability, and validity. Simultaneous analyses of item functioning were conducted using Rasch measurement theory (RMT). All tests were performed for the total score and each domain. Results: Twenty-five patients and three clinical experts participated in CE which resulted in a 27-item validation ready measure. In the validation study (N=124), nine draft items were dropped due to high missing data and/or high correlations between items. Factor analysis revealed three domains: physical functioning/mobility, sleep, and daily activities. RMT confirmed adequate item fit and placement within domains. Internal consistency ranged from 0.91 to 0.96 and test-retest from 0.84 to 0.91. All prespecified hypotheses for convergent and discriminant validity were met. Conclusions: CE and psychometric results provide evidence that the final, 18-item DPNPI is a reliable and valid PRO measure of disease impacts and treatment for DPNP. Further validation work should include responsiveness assessment. Springer International Publishing Switzerland, 2015 Diabetic peripheral neuropathic pain nationallicence Adult functioning and well-being nationallicence Patient-reported outcomes nationallicence Psychometrics nationallicence Brod Meryl The Brod Group, 219 Julia Avenue, 94941, Mill Valley, CA, USA aut Blum Steven GlaxoSmithKline, 2301 Renaissance Blvd., 19406, King of Prussia, PA, USA aut Bushnell Donald Health Research Associates, Inc., 6505 216th Street SW, Suite 105, 98043, Mountlake Terrace, WA, USA aut Ramasamy Abhilasha Actavis, Inc., Harborside Financial Center, Plaza V, 07311, Jersey City, NJ, USA aut Quality of Life Research Springer International Publishing 24/12(2015-12-01), 3001-3014 0962-9343 24:12<3001 2015 24 11136 https://doi.org/10.1007/s11136-015-1037-0 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s11136-015-1037-0 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Brod Meryl The Brod Group, 219 Julia Avenue, 94941, Mill Valley, CA, USA aut NATIONALLICENCE 700 1- Blum Steven GlaxoSmithKline, 2301 Renaissance Blvd., 19406, King of Prussia, PA, USA aut NATIONALLICENCE 700 1- Bushnell Donald Health Research Associates, Inc., 6505 216th Street SW, Suite 105, 98043, Mountlake Terrace, WA, USA aut NATIONALLICENCE 700 1- Ramasamy Abhilasha Actavis, Inc., Harborside Financial Center, Plaza V, 07311, Jersey City, NJ, USA aut NATIONALLICENCE 773 0- Quality of Life Research Springer International Publishing 24/12(2015-12-01), 3001-3014 0962-9343 24:12<3001 2015 24 11136