Patient reported outcomes for diabetic peripheral neuropathy

J Diabetes Complications. 2015 Nov-Dec;29(8):1112-8. doi: 10.1016/j.jdiacomp.2015.08.015. Epub 2015 Aug 22.


Objective: Multiple patient-reported outcomes (PROs) have been used to assess symptoms among patients with Diabetic Peripheral Neuropathy (DPN). However, there is little consistent application of measures in clinical or research settings. Our goal was to identify and compare patient reported outcome measures (PROs) specifically evaluated in neuropathy populations.

Methods: Literature search, summary, and qualitative comparison of PROs validated in neuropathy populations.

Results: We identified 12 studies of PROs evaluated in neuropathy populations that included DPN patients. Two assessed sleep quality, 5 assessed painful symptoms, and 5 assessed quality of life. The number of items per measure ranged from one to 97, and the number of domains ranged from one to 18. All had adequate internal consistency (Chronbach's Alpha>0.70). There was mild to moderate standardization of domains across measures and only a few instruments used common comparators. The spectrum of DPN symptoms addressed included: sensory symptoms, autonomic symptoms, and function, beliefs, role participation, sleep quality, and perceptions of illness.

Conclusions: There remains a need for a gold standard for DPN symptom assessment. Few existing instruments are adequately validated and the domains assessed are inconsistent. Current instrument selection should depend on the clinical and social context of the assessment.

Keywords: Diabetes; Neuropathy; Patient-reported outcome; Quality of life; Treatment.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Attitude to Health
  • Diabetic Neuropathies / physiopathology
  • Diabetic Neuropathies / therapy*
  • Disease Progression
  • Female
  • Humans
  • Male
  • Neuralgia / etiology
  • Neuralgia / physiopathology
  • Neuralgia / prevention & control*
  • Pain Management*
  • Pain Measurement / methods
  • Pain Measurement / standards
  • Quality of Life*
  • Self Report
  • Severity of Illness Index
  • Sleep Deprivation / etiology
  • Sleep Deprivation / physiopathology
  • Sleep Deprivation / prevention & control*
  • Validation Studies as Topic