title: The development and validation of a neuropathy- and foot ulcer-specific quality of life instrument.
abstract: OBJECTIVE
  The purpose of this study was to develop a questionnaire that measures patients' perceptions of the impact of diabetic peripheral neuropathy and foot ulcers on their quality of life and to assess the psychometric properties of this instrument in a sample of patients with varying severity and symptomatology of diabetic peripheral neuropathy.
  
  
  METHODS
  The neuropathy- and foot ulcer-specific quality of life instrument (NeuroQoL), generated from interviews with patients with (n = 47) and without (n = 15) diabetic peripheral neuropathy, was administered to 418 consecutive patients with diabetic peripheral neuropathy (35% with foot ulcer history) attending either U.K. (n = 290) or U.S. (n = 128) diabetes centers. Psychometric tests of NeuroQoL included factor analyses and internal consistency of scales; a series of multivariate analyses were performed to establish its criterion, construct, and incremental validity. Results were compared with those obtained using the Short Form (SF)-12 measure of health-related functioning.
  
  
  RESULTS
  Factor analyses of NeuroQoL revealed three physical symptom measures and two psychosocial functioning measures with good reliability (alpha = 0.86-0.95). NeuroQoL was more strongly associated with measures of neuropathic severity than SF-12, more fully mediated the relationship of diabetic peripheral neuropathy with overall quality of life, and significantly increased explained variance in overall quality of life over SF-12.
  
  
  CONCLUSIONS
  NeuroQoL reliably captures the key dimensions of the patients' experience of diabetic peripheral neuropathy and is a valid tool for studying the impact of neuropathy and foot ulceration on quality of life.
authors.affiliation: Departments of Medicine and Behavioral Science, Manchester Royal Infirmary, Manchester, UK. lvileikyte@med.miami.edu
authors.forename: Loretta
authors.initials: L
authors.lastname: Vileikyte
authors.forename: Mark
authors.initials: M
authors.lastname: Peyrot
authors.forename: Christine
authors.initials: C
authors.lastname: Bundy
authors.forename: Richard R
authors.initials: RR
authors.lastname: Rubin
authors.forename: Howard
authors.initials: H
authors.lastname: Leventhal
authors.forename: Pablo
authors.initials: P
authors.lastname: Mora
authors.forename: Jonathan E
authors.initials: JE
authors.lastname: Shaw
authors.forename: Paul
authors.initials: P
authors.lastname: Baker
authors.forename: Andrew J M
authors.initials: AJ
authors.lastname: Boulton
mesh_terms: D000368:Aged; D003922:Diabetes Mellitus, Type 1 / Q000503:physiopathology / Q000523:psychology; D003924:Diabetes Mellitus, Type 2 / Q000503:physiopathology / Q000523:psychology; D017719:Diabetic Foot / Q000175:diagnosis / Q000503:physiopathology* / Q000523:psychology*; D003929:Diabetic Neuropathies / Q000503:physiopathology* / Q000523:psychology*; D004522:Educational Status; D005163:Factor Analysis, Statistical; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011581:Psychological Tests; D011788:Quality of Life; D015203:Reproducibility of Results