Major amputations in type 2 diabetes between 2001 and 2015 in Spain: regional differences.

doi:10.21203/rs.2.17111/v1

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Major amputations in type 2 diabetes between 2001 and 2015 in Spain: regional differences.

https://doi.org/10.21203/rs.2.17111/v1

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published 14 Jan, 2020

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Aims To analyze the evolution of type 2 diabetes major amputations (MA) in the Regions of Spain from 2001 to 2015.Methods Descriptive study of 40,392 MA from the national hospital discharge database in patients with type 2 diabetes. The incidence rate was calculated in each region, in addition to the incidence ratios (IR) between annual incidence and 2001 incidence. The length of hospital stays and mortality risks were analyzed adjusting regression models for sex, age and smoking.Results The MA incidence rate per 100,000 persons-year was 0.48 in Spain; Canary Islands showed the highest incidence (0.81). The trend was a slight decrease or stability of the incidence in all regions except in the Canary Islands (IR 2015 = 2.0 [CI95%=1.5, 2.6]) and in Madrid (IR 2015 = 0.1 [CI95%=0.1, 0.2]). Mortality after MA was 10% in Spain; Cantabria suffered the highest risk of death [1.7 (CI95%=1.4; 2.1), p<0.001] and La Rioja the lowest risk (0.5 [CI95%=0.2; 0.9]; p = 0.026). The longest hospital stay was registered in the Canary Islands [(CI95%=11.4;13.3],p<0.001)], and the shortest in the Valencian Community [(CI95%= -7.3; -5.8),p<0.001)].Conclusion MA in the Canary Islands followed a growing trend that diverged from the downward trend in the whole country. Regional mortality and hospital stay variability advise to review the clinical management, while sudden incidence decrease in Madrid suggests to check the record procedures of hospital discharges.

Health Economics & Outcomes Research

Health Policy

Type 2 diabetes

major amputation

incidence

mortality

hospital stay

More than a half of the non-traumatic amputations of limbs occur in patients with type 2 diabetes, although during the 21st century the incidence of these amputations has been decreasing in Europe and USA. [1, 2] Despite this decrease, major amputations (MA) still remain a cause of high mortality and loss of quality of life besides with a significant increase in health costs associated to diabetes. [2] In recent decades it has been an improvement in the early detection and control of type 2 diabetes complications and, since the Saint Vincent Declaration in 1990, diabetic foot care has been intensified to reduce the incidence of major amputations. However, the increase in life expectancy of patients diagnosed with type 2 diabetes has also increased the associated morbidity. [3] Factors have been identified that increase the risk of amputations in patients with type 2 diabetes, such as advanced age, African ethnicity and male sex, while other factors such as female gender, kidney failure and congestive heart failure increase the risk of death during hospitalization. [4]

The overall incidence of amputations due to diabetes increased by 4.29% in Spain from 2001 to 2004, followed by a downward trend until 2012, around 2%. [5] In-hospital mortality due to amputations remained stable between 2001 and 2012, around 10%, resulting in an economic cost of 33% of the total cost spent in hospital treatment of type 2 diabetes complications. [6] Although there are several published works in relation to non-traumatic amputations in Spain, the majority account for the major and minor procedures globally in the analysis, or do not differentiate the type of diabetes. To our knowledge, there are no publications that have analyzed the evolution of MA incidence in patients with type 2 diabetes in the seventeen Autonomous Communities (AACC) or Regions of Spain, nor studied the possible regional heterogeneity in MA mortality or days of hospital stay.

We conducted the present study in order to analyze the evolution of major amputations incidence in patients with type 2 diabetes during the period 2001-2015 in all the AACC of Spain, as well as mortality and hospital stay in each of them.

2.1. Design and Subjects

Retrospective observational study of the Spanish National Hospital Discharges of 40,392 hospital admissions for major amputations in patients with type 2 diabetes in the seventeen AACC of Spain during the period 2001-2015. Data were collected from the Minimum Basic Data Set (CMBD, in Spanish) of the public and private hospitals. CMBD is a record of clinical-administrative data integrated into the health information system of the national health system, and contains the information at discharge of all episodes of hospitalization in the country. The database for this study was produced by the Ministry of Health with anonymized data, so neither individual written consent by patients nor ethical approval was required. We selected only cases of MA in patients with type 2 diabetes (ICD9-CM codes ranging from 250.00 to 250.92, except codes for type 1 diabetes), excluding the records of patients under 15 years of age, as well as those who did not have identified the sex or geographical area and episodes recorded in the North-African cities of Ceuta and Melilla.

This information was obtained from the principal and secondary diagnoses for each episode of admission in addition to the age, sex and hospital, current consumption of tobacco, admission date and causes for hospital discharge (including death). The length in days of hospital stay in each AACC was also analyzed, and its difference was calculated with respect to the average stay in Spain.

2.2. Statistical analysis

The scale variables were summarized according to their mean and standard deviation, or by percentiles. The categorical variables were presented by the observed frequency (%) and the 95% confidence interval (CI95%).

The MA incidence rates during the period 2001-2015 were computed for the population in each region and in the whole of Spain; for each geographical area the numerator was the sum of cases in this period in patients of 15 or more years of age, and the denominator was the sum of all the resident annual populations with that same age, obtained from the National Institute of Statistics (Spain). These regional MA rates were age-standardized by the direct method, taking as a reference the population of Spain.

In addition, in each region the ratio between the annual incidence of MA respect to the incidence of 2001 was calculated using the Open-Epi package to obtain the CI95%. The trend of these ratios was analyzed with a sequence chart to plot time series.

Linear regression models were adjusted for age, sex and smoking to analyze the differences in the length of hospital stay between the patients of each region and those of the whole of Spain. Regression coefficients and their confidence intervals are offered with a CI95%. To estimate the risk of mortality after MA, logistic regression models were adjusted for sex, age and active smoking; Odds ratios (OR) and their CI95% were obtained in this way.

Statistical analyses were performed using the statistical package SPSS 21.0, in Spanish.

The study included 40,392 non-traumatic MA in patients with type 2 diabetes in the seventeen AACC of Spain during the period 2001-2015.

Table 1 shows the number of cases in each region, as well as their age, proportion of women, active smoking, days of hospital stays and mortality derived from MA procedures. The average age of patients who underwent MA was above 72.5 years in all the AACC, except in the Balearic and Canary Islands. Among them, the prevalence of active smokers varied between 12% in Navarra and 5% in the Basque Country or La Rioja. The regions with the longest hospital stay for MA were Aragon, Asturias and The Canaries; by contrast, the Balearic Islands, the Valencian Community and Murcia were the regions with the shortest stays. Regarding mortality after MA, Cantabria showed the highest rate (17%) and La Rioja the lowest one (5%).

Table 2 presents the ratios between the annual incidence of MA and the incidence for the initial year (2001), showing a strong increase in the Canary Islands ratio (IR = 2.0 at the end of the 15 years period), compared to the moderate decrease in the whole country (IR = 0.8) and the important decrease in Madrid (IR = 0.1). This table also shows the MA incidence rates in the AACC for the entire period; the Canarian rate (0.81 / 100,000 people-year) was almost double that of Spain incidence rate (0.48 / 100,000 people- year) and triple that of Madrid (0.24 / 100,000 people-year).

Table 3 shows the multivariate adjustment of the length of hospital stay between each community and the total of Spain, as well as the risk of death in each region with respect to the whole country. Both models were adjusted for sex, age and smoking; they corroborated that the longest hospital stay by MA occurred in the Canary Islands, being 12 days longer than the average for the country and 19 days longer than the region with the shortest stay (Valencian Community). However, the risk of in-hospital death after MA was higher in Cantabria, which exceeded the overall risk in Spain by 70%, while in La Rioja there was a 50% reduction in the risk of death with respect to the country.

Figure 1 represents the trend of the annual incidence ratios compared to 2001 for two AACC of similar population size (The Canary Islands and the Basque Country) and for the global of Spain.

The study of 40,392 hospital admissions for nontraumatic major amputations occurred in patients with type 2 diabetes in Spain during the period 2001-2015 showed a high variability among AACC, both in incidence and length of hospital stay and mortality. The evolution of the incidence has been moderate decreasing in the whole of the country, more accentuated in the Community of Madrid, but with the exception of the Canarian Community that has worsened until doubling its incidence respect to the initial year of the period.

Although type 2 diabetes mortality has declined in these islands significantly in the last five years, [7] the severity of this disease in the Canary Islands is known; its current population suffers the highest incidence and prevalence [8, 9] in Spain, as well as high mortality rates due to this disease. [10] It is also known the high incidence of MA in Canarian population [11] but the trends with respect to the other regions had not been studied. We have corroborated that, far from approaching the improvement experienced in the whole of the country, the trend of the MA in the Canary Islands diverged from the other AACC during this century. At the opposite extreme is the Community of Madrid, which is known to have the lowest prevalence and mortality by type 2 diabetes in Spain [8] and for which we have now found the best trend in the country for MA incidence; however, we want to draw attention to the sudden decline of MA in this region as of 2009, which could be attributed to an error in the record procedures of hospital discharges.

Looking at the population size, the most similar region to the Canaries is the Basque Country, whose prevalence had been previously studied [12]. In both AACC the population aged over 15 years (1,804,000 inhabitants) represented 4.7% of the Spanish population in 2015 [13], but for the studied period their cases of MA were 5.8% in the Canary Islands (that is, 23% more than expected) and 4.3% in the Basque Country (that is, 9% less than expected); so, the divergent trend produced a ratio of 4.5 between their incidence rates for 2015/2001. In addition, according to previous publications [2, 3, 5] the general profile of MA patients, in order to age and gender, corresponded to a 74-year-old male; but in the Canary Islands the average age of the patients had underwent a MA was 1.5 years younger than in Spain, which increases the burden in Canarian population in terms of lost years of potential life free of disability.

In European and North-American countries there has been a decrease in the incidence of nontraumatic amputations in the last decades, [14] especially at the expense of MA in patients with type 2 diabetes [15] and particularly more evident for major amputations above the knee; [16] this has been attributed to the healthcare offered to the patient with type 2 diabetes, specially the diabetic foot care programmes. [3] This decreasing trend was also reported in Spain, [17, 5] but our study questions the homogeneity of the Spanish health system and advises to investigate the causes of the detected variability. Some aspects like the identification of access barriers and the provision of early revascularization services must be taken into account to improve the diabetic foot care programmes. [18]

The great variability that our study detected in the length of hospital stay due to MA reveals an important heterogeneity of clinical management within the National Spanish Health System. The Canarian and Valencian Communities presented the extreme data points, with 19 days of difference between them for an average hospital stay. We have not used in this article the costs provided by the CMBD because they are estimates for the entire health system and its disaggregation by AACC would not represent the real costs. Undoubtedly, the further duration of the hospital stay increases the costs of the procedures and, in addition, negatively affects the beds availability and increases the risk of nosocomial infections too. According to this, we believe that length of hospital stay management should be reviewed, especially in the Regions with the longest hospital stay, pointing out after Canary Islands the cases of Aragon and, at some distance, Cantabria.

Looking at mortality during hospitalization for MA, we have found another important difference among regions, where the highest mortality risk (Cantabria) tripled the lowest risk (La Rioja and Basque Country). These results were not modified when the Community of residence was used instead of the Community of hospitalization, nor when they were adjusted for length of stay, age, sex or smoking. It could be speculated that the MA criteria in type 2 diabetes are more conservative in some AACC than in others, and in fact most of the seven AACC whose risk of death exceeded that of Spain had a lower incidence of MA than the country average. Once again, we believe that the AACC with the worst results should review the clinical management of the medical attention given to these processes.

Despite the prevalence of smoking in MA patients was less than 22% of that reported for the general adult population of Spain, [19] it exceeded 10% in some AACC. It should be noted that this is active smoking in patients with type 2 diabetes who have been admitted to hospital due to a severe macrovascular complication, and who have probably been informed that tobacco increases the risk of amputations. It is necessary to elucidate new approaches to ensure the effectivity tobacco control policies in Spain because our article confirm that not even having suffered an amputation implies the smoking cessation. [20]

The main limitation of our study is that data came from a base of clinical-administrative hospital records and there is therefore the possibility of under-registration of type 2 diabetes as well as an underestimation of incidence of non-traumatic amputations in those cases. In addition, we can not establish a causal relationship that explains the differences detected regarding mortality in the Regions due to the lack of relevant information such as the years of evolution of type 2 diabetes, concomitant treatments or associated morbidity and mortality. Systematic reviews of studies on the incidence of amputations indicate that the variability detected could be explained by aspects related to the design, statistical methods used or the heterogeneity in the definition of the variables. [21] Despite this, the CMBD has shown a confident quality of data and a valid exploitation for health research. [22] In contrast, the main strength of our study is the large sample size, which includes patients admitted to hospitals for MA in whole of Spain.

We conclude that the evolution of MA incidence was moderately favorable for the global of Spain during the first fifteen years of this century with the only exception of the Canary Islands, which increased its incidence. The great variability in mortality and length of hospital stay due to MA questions the homogeneity of the healthcare provided by the National Spanish Health System. The Regions with worse outcomes should make efforts to identify the reasons for the observed differences and improve the healthcare quality. The abrupt decline of MA in the Community of Madrid after 2009, advises to revise the record procedures of its hospital discharges. More national and regional studies monitoring the evolution of nontraumatic amputations in patients with type 2 diabetes are needed.

FUNDING

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

CONFLICT OF INTEREST.

The authors state there is no conflict of interest associated with this manuscript.

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Table 1. Frequency of major amputations, average age, proportion of women, prevalence of active smoking, average length of hospital stay, and mortality rates in patients with type 2 diabetes in each Region, during the period 2001-2015.

	Cases n (%)	Age X±DE	Women %	Smoking %	Days of Stay P50 (P25; p75)	Mortality %
ANDALUSIA	9417 (23,3)	73,1 ±10,2	36,6	9,1	14 (8;24)	10,1
ARAGON	996 (2,5)	75,1 ±10,4	34,8	10,0	26 (17;44)	14,0
ASTURIAS	1280 (3,2)	74,6 ±10,6	38,0	7 ,0	24 (15;39)	8,1
BALEARICS	808 (2)	72,1 ±10,8	34,0	9,8	13 (8;25)	9,0
CANARY ISLANDS	2328 (5,8)	72,1 ±11,1	35,2	10,0	23 (13;41)	8,1
CANTABRIA	729 (1,8)	76,1 ±10,4	40,9	9,2	22 (13;37)	16,6
CASTILLA AND LEON	1886 (4,7)	76,8 ± 9,8	34,9	5,7	18 (11;29)	11,4
CASTILLA LA MANCHA	1611 (4)	74,4 ±10,4	36,4	10,4	16 (9;27)	9,5
CATALONIA	6352 (15,7)	73,3 ±10,6	35,5	6,4	18 (10;30)	9,1
VALENCIAN COMMUNITY	4446 (11)	72,6 ±10,5	35,1	10,0	14 (8;22)	8,4
ESTREMADURA	1198 (3)	74,5 ±10,3	37,1	5,4	16 (10;27)	10,1
GALICIA	2942 (7,3)	74,5 ±10,4	38,3	6,9	19 (11;34)	11,7
MADRID	2520 (6,2)	73,7 ±11,1	38,3	9,0	20 (12;34)	11,9
MURCIA	1576 (3,9)	73,2 ±10,2	37,2	7,7	14 (9;23)	11,2
NAVARRE	397 (1)	76,0 ± 9,6	29,5	11,6	18 (11;31)	14,1
BASQUE COUNTRY	1733 (4,3)	73,7 ±10,3	30,7	4,5	17 (11;28)	6,7
RIOJA	173 (0,4)	75,9 ± 9,2	34,7	5,2	15 (10;24)	5,2
SPAIN	40392 (100,0)	73,6 ±10,5	36,1	8,2	17 (10;29)	10,0

Table 2. Ratios between the annual incidence of major amputation and the initial year (2001) incidence of the studied period; CI95% is offered for ratios in the final year of the period (2015). Major amputation incidence rates for the period 2001 to 2015 per 100,000inhabitants * year-1.

	2001	2002	2003	2004	2005	2006	2007	2008	2009	2010	2011	2012	2013	2014	2015 (IC 95%)	Period Incidence
ANDALUCIA	1,00	0,93	1,02	1,09	1,08	1,09	1,05	0,97	0,98	0,84	0,98	0,98	0,94	0,90	0,94 (0,84;1,06)	0,71
ARAGON	1,00	1,02	1,01	1,03	1,41	1,29	1,00	1,13	1,46	1,31	1,01	1,21	1,28	1,16	1,03 (0,71;1,49)	0,34
ASTURIAS	1,00	0,97	0,80	0,96	0,61	0,93	1,05	1,10	0,89	0,72	0,51	0,43	0,39	0,57	0,59 (0,43;0,80)	0,48
BALEARICS	1,00	1,04	1,42	1,15	1,27	1,16	1,11	0,98	1,06	1,06	0,96	0,70	0,69	0,63	0,52 (033;0,82)	0,49
CANARY ISLANDS	1,00	1,25	1,37	1,63	1,68	1,69	1,74	1,76	1,89	1,72	1,84	1,97	1,57	2,05	2,00 (1,54;2,59)	0,81
CANTABRIA	1,00	0,95	1,30	1,47	1,52	1,13	1,16	1,41	1,07	0,81	0,89	0,47	0,83	0,58	0,36 (0,21;0,62)	0,59
CASTILLA AND LEON	1,00	1,02	0,85	0,90	1,07	1,02	1,15	1,05	1,10	0,91	1,05	0,93	0,95	0,88	0,84 (0,65;1,09)	0,29
CASTILLA LA MANCHA	1,00	1,04	1,17	0,99	0,88	1,27	0,95	1,16	1,09	0,79	0,86	0,85	0,81	0,94	0,84 (0,64;1,12)	0,40
CATALONIA	1,00	0,99	1,43	1,35	1,30	1,26	1,15	1,26	1,18	0,88	0,90	0,95	0,88	0,91	1,09 (0,94;1,26)	0,47
VALENCIAN COMMUNITY	1,00	1,08	1,05	1,23	1,04	1,17	1,26	1,17	1,17	1,00	1,04	0,92	0,88	0,80	0,80 (0,67;0,96)	0,50
ESTREMADURA	1,00	1,16	0,96	1,05	1,17	1,10	1,39	1,10	1,12	0,87	0,72	0,50	0,83	0,84	0,75 (0,54;1,05)	0,53
GALICIA	1,00	1,16	1,09	1,12	1,06	1,19	1,18	1,14	1,16	0,88	0,72	0,77	0,75	0,67	0,78 (0,63;0,97)	0,44
MADRID	1,00	1,23	1,09	1,06	1,12	1,14	1,18	1,07	1,07	0,19	0,18	0,25	0,21	0,18	0,11 (0,08;0,17)	0,24
MURCIA	1,00	1,09	1,07	1,21	1,16	1,18	1,28	1,20	1,21	0,96	1,15	0,89	1,17	0,99	0,80 (0,59;1,08)	0,72
NAVARRE	1,00	0,90	1,04	1,24	1,48	0,75	1,13	1,21	1,05	0,84	0,73	0,30	0,76	0,67	0,87 (0,50;1,50)	0,32
BASQUE COUNTRY	1,00	1,03	0,78	0,88	0,87	0,93	0,86	0,91	0,85	0,76	0,82	0,69	0,63	0,59	0,44 (0,32;0,59)	0,38
RIOJA	1,00	0,55	0,87	0,66	0,64	0,95	0,69	0,24	1,14	0,90	0,54	0,48	0,36	0,67	1,22 (0,61;2,41)	0,26
SPAIN	1,00	1,04	1,09	1,13	1,11	1,15	1,13	1,11	1,10	0,85	0,87	0,84	0,82	0,81	0,80 (0,75;0,84)	0,48

Table 3. Difference (CI95%) between days of hospital stay for major amputation respect to the global of Spain in patients with type 2 Diabetes. Risk (CI95%) of death in-hospital major amputation compared to Spain in patients with type 2 Diabetes. Results adjusted for age, sex and active smoking in each Region.

	Difference of Stay	Risk of Death
ANDALUCIA	-5,4 (-5,9; -4,8); p<0,001	1 (0,9; 1,1); p>0,05
ARAGON	11,9 (10,5; 13,5); p<0,001	1,4 (1,2; 1,7); p<0,001
ASTURIAS	8,2 (6,9; 9,6); p<0,001	0,8 (0,6; 0,9); p=0,010
BALEARICS	-2,9 (-4,6; -1,3); p<0,001	0,9 (0,7; 1,2); p>0,05
CANARY ISLANDS	12,4 (11,4; 13,3); p<0,001	0,8 (0,7; 0,9); p=0,014
CANTABRIA	7,7 (5,9; 9,4); p<0,001	1,7 (1,4; 2,1); p<0,001
CASTILLA AND LEON	1,3 (0,2; 2,4); p=0,021	1,1 (0,9; 1,2); p>0,05
CASTILLA LA MANCHA	-1,8 (-2,9; -0,6); p=0,004	0,9 (0,8; 1,1); p>0,05
CATALONIA	0,1 (-0,5; 0,8); p>0,05	0,9 (0,8; 0,9); p=0,017
VALENCIAN COMMUNITY	-6,6 (-7,3; -5,8); p<0,001	0,8 (0,7; 0,9); p=0,003
ESTREMADURA	-2 (-3,4; -0,7); p=0,003	0,9 (0,8; 1,2); p>0,05
GALICIA	5,6 (4,8; 6,5); p<0,001	1,2 (1,1; 1,3); p=0,006
MADRID	4,3 (3,3; 5,2); p<0,001	1,2 (1,1; 1,4); p=0,001
MURCIA	-5,3 (-6,5; -4,1); p<0,001	1,2 (0,9; 1,4); p>0,05
NAVARRE	2,8 (0,5; 5,2); p=0,019	1,4 (1,1; 1,9); p=0,014
BASQUE COUNTRY	-1,6 (-2,8; -0,5); p=0,006	0,6 (0,5; 0,8); p<0,001
RIOJA	-4,4 (-7,9; -0,8); p=0,016	0,5 (0,2; 0,9); p=0,026

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published 14 Jan, 2020

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Review #1 received at journal
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Editorial decision: Minor revision
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Major amputations in type 2 diabetes between 2001 and 2015 in Spain: regional differences.

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