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The purpose of this study was to determine the incidence of non traumatic lower extremity amputations (LEAs) in diabetic and non diabetic subjects in Madrid, Spain, and their direct cost. All patients who underwent LEAs between the 1st of January 1994 and the 31st of December 1996, and who had lived in area 7 of the city (569,307 inhabitants) for at least the last 6 months, were identified through operating theatre records cross checked with Vascular Surgery Department discharge records. In addition, the direct cost of LEAs per year was estimated, taking into account the length of the hospital stay, the period of rehabilitation in the outpatient clinic after discharge, and the use of artificial limbs and their maintenance. The incidence of LEAs was 1.6 (95 % CI :1.1 2.2) per 105 non diabetic subjects and 46.1 (95 % CI :34.5 57.6) per 105 diabetic patients. Relative risk was 28. Total direct costs associated with LEAs per year were US$ 56,131 in the diabetic population and US$ 30,765 in the non diabetic population. Thus, potential cost savings associated with excess amputations in the diabetic population was estimated at US$ 541,353 per year or US$ 94,736 per 105 inhabitants. It is concluded that the incidence of LEAs in both diabetic and non diabetic populations in area 7 is the lowest reported in European countries. The potential cost savings per 105 inhabitants and per year is estimated at US$ 94,736.
Notre objectif était de déterminer l’incidence des amputations non traumatiques des extrémités inférieures (AEI) chez des sujets diabétiques ou non, et leurs cots directs, à Madrid. Tous les patients ayant subi une AEI entre le 1 Janvier et le 31 Décembre 1996, vivant dans la zone 7 (569 307 habitants) depuis au moins 6 mois, ont été identifiés grce aux registres opératoires. Le cot direct annuel des AEI a été estimé en prenant en compte la durée de l’hospitalisation, la durée de la rééducation après la sortie de l’hpital, l’usage de membres artificiels et leur maintenance. L’incidence des AEI était de 1,6 pour 105 chez les non diabétiques (intervalle de confiance à 95 % : 1,1 2,2), et de 46,1 pour 105 diabétiques (IC : 95 % : 34,5 57,6). Le risque relatif était de 28. Les cots directs annuels étaient de 561,312 dollars US chez les diabétiques et de 30,765 dollars chez les non diabétiques. En prenant cela en compte, le cot associé aux amputations supplémentaires chez les diabétiques était de 541,353 dollars par an, soit 94,736 dollars par 105 habitants. En conclusion, l’incidence d’AEI chez les diabétiques et les non diabétiques de notre zone est la plus faible décrite dans les pays européens. Ce cot annuel peut tre estimé à 94,736 dollars par 105 habitants. 519 523.
Mots clés :amputation, impact économique, cot, économie de la santé. Calle Pascual, servicio de Endocrinologia Metabolismo y Nutricin 2aS. Hospital Universitario S. Carlos. c/ Martin Lagos s/n. E 28040 Madrid. Spain. Tel : 34 1 3303280.
Servicio de Endocrinologia, Metabolismo y Nutricin and (1) Servicio de Cirugia Vascular. Hospital Universitario S. Carlos. Madrid
iabetes is the main cause of non traumatic lower extremity amputations (LEAs) [1,2]. More than 50 % of LEAs are performed in subjects with diabetes mellitus. Moreover, they are carried out at an earlier age and at a higher level than in the non diabetic population [3 6]. The relative risk for LEAs is roughly 15 [6 8]. A substantial proportion of LEAs is thought to be preventable by the provision of appropriate foot care programmes [4 6,9]. Recent studies [10 13] have shown differences in the incidence of LEAS, which reflect variations in risk factors including diabetes prevalence, health care and lifestyle. Several studies [14,15] have described a lower cardiovascular mortality in Spain than in other European countries. However, data about the incidence of LEAs in Spain are lacking. Thus, the purpose of this study was to assess the incidence of LEAs in diabetic and non diabetic subjects as well as their direct economic cost.
RESEARCH DESIGN AND METHODS
The National Health Service has divided Madrid into 13 health areas. According to the last census in 1991, the total population of health area 7 on which this study is based was 569,307 (261,529 males, 307,778 females). The population with diabetes mellitus was estimated according to the Aragn study  in which the prevalence of diabetes mellitus (diagnosed and unknown) in persons between 10 and 74 years of age was found to be 6.1 %. Populations from both Madrid and Aragn are mainly Caucasian. San Carlos) with the only specialized department for vascular patients (Vascular Surgery). All LEAs in subjects from Area 7 are performed in this department.
Amputations were defined according to the Global Lower Extremity Amputation Study  as the complete loss of any part of the lower limb. A minor LEA was any amputation distal to the ankle joint. All patients who underwent a first LEA between the 1st of January 1994 and the 31st of December 1996 were identified through operating theatre records and Vascular Surgery Department discharge records. The Social Security system in our country covers between 70 and 100 % of the cost of drugs prescribed by a Social Security doctor. Patients suffering from LEAs usually have some pharmacological treatment. Thus, prescribing physicians (306 in Area 7) were used as an additional data source in order to identify individuals who were amputated outside area 7. Only patients who had resided in area 7 for at least the last 6 months were included in the study. Date of birth, sex, address, and hospital case notes were checked. Diabetes mellitus was defined according to WHO criteria.
Two tests were performed to evaluate the eyesight and physical capacity of patients to inspect their own feet. Patients were considered to have adequate eyesight capacity if they were able to read a letter 0.4 cm in size from 50 cm with their usual glasses. Patients were considered to have acceptable physical mobility if they could see the sole of their foot, using a mirror if necessary.
The incidence of LEAs was calculated as the proportion of amputated subjects for 105 non diabetic or diabetic persons. Relative risk (incidence ratio) was the ratio of LEA incidence rates in the diabetic population compared to that for the non diabetic population. For a more meaningful assessment, subjects were divided into three age groups, and calculations were carried out for each group.
The direct cost of LEAs was determined by taking into account the length of hospital stay, the period of rehabilitation in the outpatient clinic after discharge, and the use of artificial limbs and their maintenance. Data about the average costs for one day of hospitalization and rehabilitation in Spain were obtained from the Ministry of Health . San Carlos) was US$ 374 (46,718 pesetas). Data about artificial limbs and their maintenance cost were calculated according to the cost charged to Social Security . The cost of artificial limbs according to LEA level was : above the knee US$ 6,500, at the knee US$ 4,565, below the knee US$ 2,865, at the ankle or tarsus US$ 1,500, at the tarsometatarsal joints US$ 720. The maximun cost charged to Social Security for insoles or special shoes after metatarsal, toe or ray amputation was US$ 160.
In addition, we reckoned the cost of diabetes related LEAs as if the incidence of LEAs in diabetic persons were identical to that found in non diabetic subjects in order to estimate the cost associated with excess LEAs in the diabetic population. The potential cost savings (or excess of cost related to diabetes) was the current cost minus the estimated cost. the Levene test) was used to assess differences between groups. Incidence data are expressed as the mean (95 % CI). 65 % of all non traumatic LEAs were performed in diabetic patients. a crude LEA risk 28 fold higher in the diabetic population for both sexes (Table I). Incidence increased with age in both diabetic and non diabetic groups, but age at amputation was 7 years earlier in diabetic than non diabetic subjects (p 0.05), and at least 8 years lower in men than in women (p 0.02). People with diabetes mellitus had minor LEAs more frequently than non diabetic subjects (60 vs 15 % ; p 0.02). Nevertheless, length of hospital stay was identical : 51 in hospital days for LEA in diabetic patients compared with 52 in non diabetic subjects. The number of subjects meeting the eyesight and mobility requirements for foot inspection was low and at a similar level in both diabetic and non diabetic populations. Nevertheless, only 15.7 % of non diabetic subjects and 2.7 % of diabetic patients were being examined by a chiropodist at least once every two months. Table II shows the total direct cost per year associated with LEAs : US$ 561,312 for the diabetic population and US$ 307,658 for the non diabetic population. The average cost for LEA was similar in diabetic and non diabetic subjects, respectively US$ 35,100 and 35,500. In addition, if the incidence of LEAs in the diabetic population were identical to that found in the non diabetic population, the total cost would be reduced to US$ 19,355 per year. Thus, the potential savings associated with excess amputations in the diabetic population would be US$ 541,353 per year.(Voir Figure)(Voir Figure)
This study shows that the incidence of LEAs in both diabetic and non diabetic populations in Spain is the lowest reported among European countries. The same is true for coronary heart disease and stroke incidence in non diabetic subjects [14,15]. A Mediterranean diet, low tobacco and alcohol consumption and other unknown factors may be involved. Nonetheless, subjects with diabetes mellitus had a relative risk of 28 in this study, indicating that diabetic foot care remains suboptimal in our area.
Other studies carried out over the last 15 years have demonstrated marked variability in the incidence of LEAs [3 13, 20, 21]. In our study, the incidence of LEAs was comparable to that found for non diabetic subjects in an Asian population in Leicester, England, but higher for the diabetic population .
As in most reports, LEA incidence in our study was higher in men than in women in both diabetic and non diabetic populations. Moreover, the age at amputation was 8 years earlier in diabetic subjects compared to non diabetic subjects, in accordance with results in Finnish diabetic women . The greater number of LEAs in subjects with diabetes mellitus in this study was mainly due to minor amputations. Strikingly, less than one of five amputated subjects was able to perform routine foot care because of poor eyesight or mobility. The fact that four of five subjects were living alone (or with no one capable of performing their foot care) posed a considerable problem. Nevertheless, patients who had amputations did not usually go to the podiatrist. In Spain, podiatric care is not reimbursed by Social Security, which is the most likely explanation for the low rate of chiropody examination in our patients.
Although the current cost of diabetes related LEAs in Spain is not known and impossible to determine with current data, this study provides helpful information for estimating LEA cost in both diabetic and non diabetic populations as well as the potential savings relative to the excess of diabetes related costs.
The average length of LEA related hospital stay in this study was similar for diabetic and non diabetic populations, even though 84 % of LEAs in non diabetic subjects were major amputations versus only 37 % in diabetic subjects. As in other studies [22 24], hospital stay was consistenly longer in diabetic than non diabetic subjects when similar LEA levels were compared (data not shown).
The total cost associated with hospitalization, rehabilitation, and an artificial limb was more than US$ 864,000 per year (more than US$ 150,000 per 100,000 inhabitants) : US$ 564,000 in the diabetic population and US$ 308,000 in the non diabetic population. Moreover, maintenance of an artificial limb and rehabilitation are usually lifetime obligations since an artificial limb (or part) has to be changed yearly or sooner in order to readapt it to the size of the stump. This may represent over 40 % of total cost. Comparison with other studies [22 24] is difficult since to our knowledge the present study is the first to consider the cost of the artificial limb, its maintenance and rehabilitation after hospital discharge. All these aspects are covered by the Social Security system in Spain. This study did not take into account the decreased productivity of people suffering from LEAs because it was negligible. More than 80 % of the amputated were over 65 years of age and retired, whereas 5 % were unemployed, and only 2 % were working. Other aspects of the direct cost, such as continued medical care after hospital discharge, disability, pharmacological products and other medical facilities were not included in this study so that the actual costs associated with LEAs are even higher than those reported here.