DEVELOPMENT OF THE DIABETIC PERIPHERAL NEUROPATHIC PAIN IMPACT MEASURE- A PATIENT-REPORTED OUTCOME MEASURE OF THE IMPACT OF DPNP ON FUNCTIONING
Author(s)
Brod M1, Carson R2, Ramasamy A2, Setyawan J31The Brod Group, Mill Valley, CA, USA, 2Forest Research Institute, Jersey City, NJ, USA, 3Shire Pharmaceuticals, Wayne, PA, USA
OBJECTIVES: Diabetic Peripheral Neuropathic Pain (DPNP) is a poorly understood complication of diabetes that has serious consequences for patients’ physical functioning and daily activities. A well-developed patient-reported outcome (PRO) measure that can assess the impact of DPNP on function and that is sensitive to change would facilitate research important to patients. The purpose of the study was to develop a measure of key impacts important to patients with DPNP. METHODS: Diabetic Peripheral Neuropathic Pain (DPNP) is a poorly understood complication of diabetes that has serious consequences for patients’ physical functioning and daily activities. A well-developed patient-reported outcome (PRO) measure that can assess the impact of DPNP on function and that is sensitive to change would facilitate research important to patients. The purpose of the study was to develop a measure of key impacts important to patients with DPNP. RESULTS: Saturation of concepts was reached after 3 focus groups and telephone interviews with a total of 25 DPNP patients (demographics: average age 52 years old, 68% male, 60% White). The average duration of DPNP was 5 years (range 1-20 years) and the average self-reported pain score (scale 0-10) was 6.9 (range 4-10). The theoretical framework described two domains of impact: Physical Functioning and Daily Functioning. Based on the results of the cognitive debriefing a 27-item, validation ready version of the measure with 4 domains (Physical Functioning–Sleep, Physical Functioning-Mobility, Daily Functioning- Daily Activities and Daily Functioning-Relationships) was generated. CONCLUSIONS: The Diabetic Peripheral Neuropathic Pain Impact Measure is believed to accurately capture relevant DPNP patients’ experiences as it relates to their ability to function. Data generated from the measure should assist clinicians in assessing key impacts in patients with DPNP, facilitate development of targeted treatments and provide a meaningful measurement of treatment effect.
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PDB46
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Diabetes/Endocrine/Metabolic Disorders