The Development and Validation of a Neuropathy- and Foot Ulcer-Specific Quality of Life Instrument
- Loretta Vileikyte, MD1,
- Mark Peyrot, PHD23,
- Christine Bundy, PHD1,
- Richard R. Rubin, PHD4,
- Howard Leventhal, PHD5,
- Pablo Mora, PHD5,
- Jonathan E. Shaw, MD1,
- Paul Baker, MD6 and
- Andrew J.M. Boulton, MD1
- 1Departments of Medicine and Behavioral Science, Manchester Royal Infirmary, Manchester, U.K
- 2Center for Social Research, Loyola College, Baltimore, Maryland
- 3Department of Medicine, Johns Hopkins University, Baltimore, Maryland
- 4Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland
- 5Department of Psychology, University of Rutgers, New Brunswick, New Jersey
- 6The Diabetes Center, Bolton, U.K
- Address correspondence and reprint requests to Dr. Loretta Vileikyte, Division of Endocrinology, University of Miami School of Medicine, P.O. Box 016960 (D-110), Miami, FL 33101. E-mail: lvileikyte{at}med.miami.edu
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.
RESEARCH DESIGN AND 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 (α = 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.
- MCS, Mental Component Summary
- NDS, Neuropathy Disability Score
- NeuroQoL, neuropathy-specific quality of life instrument
- PCS, Physical Component Summary
- SF, Short Form
- VPT, vibration perception threshold
Footnotes
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A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
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- Accepted May 30, 2003.
- Received March 7, 2003.
- DIABETES CARE
