The Development and Validation of a Neuropathy- and Foot Ulcer-Specific Quality of Life Instrument

Author:

Vileikyte Loretta1,Peyrot Mark23,Bundy Christine1,Rubin Richard R.4,Leventhal Howard5,Mora Pablo5,Shaw Jonathan E.1,Baker Paul6,Boulton Andrew J.M.1

Affiliation:

1. Departments of Medicine and Behavioral Science, Manchester Royal Infirmary, Manchester, U.K

2. Center for Social Research, Loyola College, Baltimore, Maryland

3. Department of Medicine, Johns Hopkins University, Baltimore, Maryland

4. Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland

5. Department of Psychology, University of Rutgers, New Brunswick, New Jersey

6. The Diabetes Center, Bolton, U.K

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.

Publisher

American Diabetes Association

Subject

Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference26 articles.

1. Shaw JE, Zimmet PZ: The epidemiology of diabetic neuropathy. Diabetes Rev 7:245–252, 1999

2. Boulton AJM, Malik RA: Diabetes mellitus: neuropathy. In Endocrinology. 4th ed. DeGroot LJ, Jameson JL, Eds. Philadelphia, WB Saunders Co, 2000, p. 868–878

3. Reiber GE: Epidemiology of foot ulcers and amputations in the diabetic foot. In The Diabetic Foot. 6th ed. Bowker JH, Pfeifer MA, Eds. St. Louis, MO, Mosby, 2001, p. 13–32

4. Pecoraro RE, Reiber GE, Burgess EM: Pathways to diabetic limb amputation: basis for prevention. Diabetes Care 13:513–521, 1990

5. Vileikyte L: Psychological aspects of diabetic peripheral neuropathy. Diabetes Rev 7:387–394, 1999

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