Health-related quality of life in patients with diabetes mellitus and foot ulcers

Abstract

To investigate health-related quality of life (HRQL) in diabetes patients separately for those with current foot ulcers, those with primary healed ulcers, and those who have undergone minor or major amputations. The EuroQol quality of life (QoL) questionnaire including a visual analogue scale (VAS) was sent to 457 patients treated for foot ulcers by a multidisciplinary team between 1995 and 1998. Patients who never had undergone any lower extremity amputation (LEA) were classified according to whether an ulcer was present at time of the survey or if they had healed primarily. Patients who had undergone any amputation were classified into a minor or a major amputation group according to their maximal amputation status. Patient characteristics and ulcer status at time of the survey were collected using patient records and pre-set forms used to follow-up of foot ulcer patients specifically. A response rate of 70% was obtained. Completion rates on single items were high. There were no differences in patient characteristics between respondents and non-respondents. Patients with current foot ulcers rated their HRQL significantly lower than patients who had healed primarily without amputation. Major amputation reduced the EuroQol index value, while the VAS value was reduced by other diabetic complications and increased by living with a healthy partner. Both values were reduced by a current foot ulcer. EuroQol can be used to investigate HRQL in diabetic patients with foot complications. Patients with current foot ulcers value their QoL lower than primary healed patients. QoL is reduced after major amputations.

Introduction

Successful healing of diabetic foot ulcers often requires long treatment periods that can be both painful and demanding. A considerable amount of time must be spend on clinic visits, hospitalisation, and frequent changes of ulcer dressings. The presence of a foot ulcer also creates anxiety due to the possibility of amputation. In addition to the trauma of an amputation, the accompanying disability also necessitates changes in living conditions and housing situation, which involves a burden on both patient and family. Quality of life (QoL) is therefore important in diabetic patients with foot ulcers, both during ongoing treatment and, especially for amputees, after healing has been achieved.

The influence of foot ulcers and amputations on health-related quality of life (HRQL) in patients with diabetes mellitus has been discussed Reiber et al., 1998, Eckman et al., 1995 and a limited number of studies of HRQL for this patient group have been published Brod, 1998, Carrington et al., 1996, Childs et al., 1998, Hux et al., 1999.

HRQL can be measured with generic measures or with disease-specific instruments. Several reports have covered HRQL in persons with diabetes. These reports have often focused on general QoL as it varies with different therapies for improving blood glucose control. Examples of such disease-specific instruments are the Diabetes Care Profile (DCP), the Diabetes Health Profile (DHP), the Diabetes Quality of Life Measure (DQOL), and the Diabetes Impact Management Scale (DIMS) Anderson et al., 1997, Hammond & Aoki, 1992, Jacobson et al., 1994, Meadows et al., 1996. Some generic or global instruments used in populations with diabetes are, the Nottingham Health Profile (NHP), the Medical Outcomes Study Short Form 36 (SF-36), and EuroQol (EQ-5D) Anderson et al., 1997, Jacobson et al., 1994, Keinänen-Kiukaanniemi et al., 1995, U.K. Prospective Diabetes Study Group, 1999. None of these studies have addressed specifically foot complications in diabetic patients. A disease-specific diabetic foot ulcer instrument has been presented (Conway et al., 1998), but we are unaware of published results from trials. Research with validated instruments on larger foot ulcer populations with different treatment outcomes is required.

EuroQol may be useful in investigating HRQL in patients with foot ulcers and diabetes mellitus: It has previously been used in patients with rheumatoid arthritis (Hurst et al., 1997), a patient population which has similar problems with severe chronic disease, mobility reductions, and presence of disability and pain. EQ-5D has also recently been used by the U.K. Prospective Diabetes Study Group (1999) to assess QoL in Type II diabetic patients. Moreover, EQ-5D is limited in size and includes relatively few questions and the results are suitable for both clinical purposes and health-economic analyses. Results from EQ-5D can also be used in comparisons with the general population and with other disease groups.

The aim of this study was to investigate HRQL in patients with diabetes and foot problems and to analyse whether EQ-5D is an acceptable instrument for differentiating patients with current foot ulcers from patients with primary healed ulcers or patients who have undergone minor or major amputations. Hypotheses to be examined were whether patients who currently had foot ulcers experienced lower HRQL than those whose ulcer had already healed, and whether patients who have undergone a minor or a major amputation rate their HRQL lower than those who have healed without any amputation.