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Patient reported outcomes for diabetic peripheral neuropathy
Christine Bredfeldt1, Andrea Altschuler2, Alyce S Adams2
1Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, Rockville, MD; Lewin Group, Falls Church, VA.
Journal of Diabetes and Its Complications
|September 20, 2015
Summary
Patient-reported outcome measures (PROs) for diabetic peripheral neuropathy (DPN) symptoms lack standardization. Further validation is needed to establish a gold standard for consistent DPN assessment in clinical and research settings.
Area of Science:
- Neurology
- Clinical Research
- Patient-Reported Outcomes
Background:
- Diabetic Peripheral Neuropathy (DPN) impacts patients through various symptoms.
- Multiple patient-reported outcomes (PROs) exist for DPN symptom assessment.
- Current application of PROs in clinical and research settings lacks consistency.
Purpose of the Study:
- To identify and compare PROs specifically evaluated in neuropathy populations.
- To assess the validation and domain consistency of existing DPN symptom measures.
Main Methods:
- Literature search and summary of PROs.
- Qualitative comparison of validated PROs in neuropathy populations.
- Analysis of PRO characteristics including item count, domain count, and internal consistency.
Main Results:
- Twelve studies involving PROs in neuropathy populations, including DPN patients, were identified.
- PROs assessed sleep quality, painful symptoms, and quality of life, with varying item and domain counts.
- Measures demonstrated adequate internal consistency, but domain standardization and use of common comparators were limited.
Conclusions:
- A gold standard for DPN symptom assessment is currently lacking.
- Existing instruments show inconsistent domain assessment and require further validation.
- PRO selection should be tailored to the specific clinical and social context.
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