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Örebro University School of medicine Degree project 30 ECTS 16-01-14

 

 

Peripheral arterial disease (PAD)

- A descriptive cost study with gender analyses.

     

Author: Rebecka Wästgård, bachelor degree (major in medicine), Örebro University. E-mail: rebwah111@studentmail.oru.se

Supervisor: Birgitta Sigvant, MD, PhD, Head of Department of Vascular Surgery, Central Hospital, Karlstad.

E-mail: birgitta.sigvant@liv.se

Co-supervisor: Antonio Pereira Filho, resident physician. Department of Vascular Surgery, Central Hospital, Karlstad.

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ABSTRACT

Peripheral Arterial Disease (PAD) is reaching pandemic levels, leading to a health economic burden as PAD affects a great amount of the Swedish population. The prevalence is higher than the estimate of people suffering from diabetes mellitus (DM) and breast cancer. Among elderly in Sweden, almost 20 % are affected and it is more common among women, although the gender specific prevalence is debated. The condition involves a decreased quality of life, with pain, functional impairment, risk of limb loss and an increased mortality rate, as PAD is highly associated with development of other cardiovascular conditions. Furthermore, PAD related health care cost are substantial and is predicted to increase. The aim of this study was to estimate PAD related health care costs for patients with PAD as primary diagnosis (defined by ICD-10). In 2005 to 2010, 3675 PAD patients were enrolled from Östergötland County. When studying health care costs gathered from The National KPP register (cost per patient), results reveal that men presents with higher cost than women, related to one individual health care appointment, however, when analysing total costs for PAD over this six-year time period, numbers are nearly equal between genders. The study indicates more but less expensive contacts for women and fewer but more costly contacts for men, which results in cost equality for both genders over time. The issue of cost is of highest health economic interest. As the life expectancy increases,

elucidating PAD related health care costs is important for quality assurance and treatment of these patients. To answer the question why these differences exist, further studies need to be presented.

Key words: Ancle brachial index (ABI), co-morbidity, health care contact, health economic, KPP (cost per patient), peripheral arterial disease (PAD), prevalence, register, risk factor.

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CONTENTS   i. ABSTRACT  ...  1   ii. CONTENTS  ...  2   iii. ABBREVIATIONS  ...  3   1.  INTRODUCTION  ...  4  

2. MATERIALS AND METHODS  ...  6  

2.1 Ethical considerations  ...  6  

2.2 Identification of study population  ...  6  

2.3 Cost analyses  ...  6   2.4 Statistical analyses  ...  7   3. RESULTS  ...  8   4. DISCUSSION  ...  11   5. CONCLUSION  ...  13   6. ACKNOWLEDGEMENTS  ...  13   7. REFERENCES  ...  14  

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ABBREVIATIONS  

ABI- Ankle brachial index CV- Cardiovascular

CVD- Cardiovacular disease CLI- Critical limb ischemia DM- Diabetes Mellitus IC- Intermittent claudication IHD- Ischemic heart disease KPP- Cost per patient MI- Myocardial infarction PAD- Peripheral arterial disease

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1. INTRODUCTION  

Public health decision makers need to decide how to allocate health care resources, such as health care facilities, staff, material and time. Health economic research is one way to elucidate the health economic topic in order to optimize and prioritize limited resources. Globally

cardiovascular disease (CVD) are increasing, by far, ischemic heart disease (IHD) and stroke are the main cause of death world wide (46 %) [1]. Lower limb arteries is one of the vascular

territories and peripheral arterial disease (PAD) is defined as widespread arterial atherosclerosis from the aortic bifurcation and further more distal [2-4]. The disease is usually diagnosed with an ankle brachial index (ABI) below 0.90 with or without symptoms [5-6,7] although, far from all patients presents with symptoms, estimated to only between 10-30 %, yet, mortality rate are high [5,8].

PAD is common, in a recent performed population based study in Sweden, the prevalence was found to be 20 % among subjects over 60 years which indicates that almost half a million suffers from PAD today [9]. To put this in perspective is the estimate of people suffering from diabetes mellitus (DM) and breast cancer, 400.000 respectively 94.406 patients in Sweden which makes PAD a substantial health economic issue [10-11] and also a common global condition [3-4,12]. Interventions are often first performed when symptoms is presented to the patient, although the proceedings differs between countries [9]. The PAD prevalence increases significantly with higher age [13-14]. The gender specific prevalence is not yet defined but previous Swedish studies reveals that women are more likely to suffer from PAD than the male population [9,15]. Not much is known about sex differences in PAD prevalence [9], although, earlier studies show a higher prevalence for women when estimating ABI separately [1,15-17]. Egorova N. et. al, indicate gender differences in pathogenesis as well as clinical manifestations related to arterial disease [17].

The association between PAD and cardio- and cerebrovascular conditions is well known, even the asymptomatic stage [6-7,12,18]. Several studies indicate a strong relationship between PAD and later development of other cardiovascular disease (CVD) such as stroke or myocardial infarction (MI) [2,6,13,18-20]. PAD is also associated with increased cardiovascular mortality on par with symptomatically unstable angina pectoris [21-23]. Smoking, hypertension, and diabetes are some of the risk factors that patients with overall vascular disease can present with [8,12,14]. Patients who suffer from CLI are diabetic to a great extent and the critical connection

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of cerebral- and cardiovascular events in addition as these patients often suffer from multiple illnesses initially, leads to a high mortality rate of PAD [6-7,12,24]. Intermittent claudication (IC) and critical limb ischemia (CLI) are the symptomatic stages and has both a considerable impact on quality on life [25]. Many patients experience a low quality of life, with pain and functional impairment, the condition is also the most common cause of amputation of limbs [7,26-28]. Functional decline also leads to an indirect economic societal burden as patients are forced to earn a living from medical insurance, due to reduced work capacity instead of employment and occupation [12,24].

In addition to patients decreased quality of life, care related cost to PAD is substantial [22,27-28]. Numbers reaches the same expenses relative to CVD and coronary artery disease (CAD) [28-29]. Sweden has well-developed and reliable data registers related to health care cost, among other parameters such as diagnosis, hospital care and use of medication. The KPP (cost per patient) register is a Swedish individual based register. This register provides information on e.g. patient data, hospital- and medical services (Figure 1.), which allow the identification of patients enrolled in this study and also, their medical resources utilization [30]. PAD reaches pandemic results worldwide, leading to a global burden [8,16,27-28]. From a treatment perspective, knowledge about possible differences in pathogenesis as well as symptoms between genders plays a crucial role [16]. Research is one way to enable treatment and enhance preventive care for patients in risk areas. The primary aim of this study was to estimate and identify PAD related health care costs during a six-year time period in Östergötland County with a special focus on gender differences.

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2. MATERIALS AND METHODS 2.1 Ethical considerations

As the study is solely descriptive without personal data included and no journal review has been conducted, an ethical application is not relevant.

2.2 Identification of study population

From January 1st 2005 to December 31st 2010, 13.911 health care contacts from all patients in Östergötland County with PAD as primary diagnose code were gathered from the national KPP-register. Patients were identified with PAD from the International Classification of Disease-10 (ICD-10) with these following diagnose codes and their sub groups as primary diagnose;

170.2 Atherosclerosis of arteries of extremities 173.9 Peripheral vascular disease unspecified

174.3 Embolism and thrombosis of arteries of lower extremities 174.4 Embolism and thrombosis of arteries of extremities, unspecified 174.5 Embolism and thrombosis of iliac artery

2.3 Cost analyses

Costs were also collected from the individual-based national KPP-register. Data on costs were analysed by first identifying cost per contact, then proceeding with cost over time and cost per patient and year. To achieve more precise groups for comparison, patients were stratified for sex and age.

2.3 Register of Cost per Patient

The Swedish Association of Local Authorities and Regions (SKL) provide a database of cost per patient (KPP). Data registered in the KPP database is displayed in Figur 1. The KPP register is a Swedish individual based register and highly validated [30].

           

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2.4 Statistical analyses

Student´s t-Test was carried out to analyse sex difference of age. Statistical analyses were performed using SPSS and Windows Excel. P-values below 0.05 were considered statistically significant.

   

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3. RESULTS  

The total number of health care contacts in Östergötland County, collected from the KPP database was 13.911. The age distribution of men and women are illustrated in Table 1. These contacts were equivalent to 3675 patients, of these, 1910 men and 1765 women, giving the study cohort.

Figure 2 illustrates cost per contact, related to one specific health care admission. Men presents with higher cost than women in all age group beside in group 75-84 year.

Figure 2. Cost (SEK) per contact for PAD (mean) separated by age and sex.

0   2000   4000   6000   8000   10000   12000   14000   16000   18000   <  65   65-­‐74   75-­‐84   >  85   Men   Women  

Men Women Total P-value Age (years) at enrolment (mean) 73.8 77 75.4

Numbers of patients (n) 1910 (51 %) 1765 3675 Age groups < 65 (%) 416 (11.3) 300 (8.1) 716 (19.5) 0.06 65-74 (%) 549 (14.9) 343 (9.3) 892 (24.3) 0.0005 75-84 (%) 567 (15.4) 632 (17.2) 1199 (32.6) 0.54 > 85 (%) 313 (8.5) 555 (15.1) 868 (23.4) 0.0001

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The cost (mean) per patient and year during the total study time period is shown in Figure 3. Men and women present similar cost in age group 65-74 years and 75-84 years. A greater

difference can be seen in patients that are older than 85 years old; where men cost approximately 10.000 SEK (mean) more than women.

Figure 3. Cost (SEK) per patient per year for PAD (mean) separated by age and sex.

Figure 4 presents total cost (mean) per patient per year, separated by sex. The diagram illustrates the time trend over the total study period (2005-1010) and result show that PAD cost has

increased in both men and women without dramatically differences between sexes. Women cost 28 % more in 2010 than in 2005, and men respectively, 56 % more.

Figure 4. Cost (SEK) per patient per year divided by sex (mean).

0   10000   20000   30000   40000   50000   60000   70000   80000   <65   65-­‐74   75-­‐84   >85   Men   Women   0   10000   20000   30000   40000   50000   60000   2005        2006          2007          2008            2009          2010   Men   Women  

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Different types of health care admissions are presented in Table 2. Men are more prone to seek doctor appointment than women. The major difference between genders is appointments for medical treatment, which women seek much more frequently than men, 793 contacts for women and 389 for men.

Table 2. Total numbers of contacts separated by type of health care admission and sex. (Number of (mean) contact per patient)

*IDA= indirect doctor appointment (contact via telephone etc.), IMT = indirect medical treatment (care contact with another health care provider without the physical presence of the patient).

Table 3 shows total cost divided by type of health care appointment and sex. Men presents with higher cost in hospitalization events compared women, but the major cost difference are seen in the medical treatment group were women cost more than 100 % more than men.

Table 3. Cost (SEK) divided by type of health care contact and sex (mean).

Type  of  contact                                                        Men                                                              Women                                                                                                  Total  

Hospitalization   93412   89538   91475  

Doctors  appointment   11073   11180   11127  

Medical  treatment   983                                                                    2445   1714   Others*   380                                                                  267   324   *IDA= indirect doctor appointment (contact via telephone etc.), IMT= indirect medical treatment (care contact with another health care provider without the physical presence of the patient)

Type  of  contact   Men   Women                            Total  

Hospitalization     1395  (0.73)   1252  (0.70)   2647  

Doctors  appointment   5045  (2.6)   4385  (2.5)   9430  

Medical  treatment   389  (0.2)   793  (0.4)   1182  

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4. DISCUSSION  

This study investigated cost for PAD with respect to gender differences. Results revealed that men presented with higher cost in almost every age group than women when analyzing one specific health care admission. Number of various type of health care contacts seem to differ between gender, women tend to seek health care more often than men, however, to a great extent, less costly contacts. Men are more likely to be admitted to hospital than women and seen in this study, hospitalization events are the most expensive contacts in provided PAD health care. Interpretation of these differences is complex. As this study is exclusively a descriptive cost study with health economic as center point, only speculations regarding why possible gender inequalities in PAD related health care cost exists can be expressed. Although, discussion on this topic is highly important for several reasons, most essential to allocate health care resources, enhance prevention-based care and to evaluate health economics in Sweden for the future. PAD-related health care cost is substantial; the total cost of cardiovascular disease in 2010, estimated to 61.5 billion SEK [31], letting us understand the magnitude of these conditions from a health economic perspective. In addition to this, costs are expected to rise in expenses in years ahead. Due to an increased life expectancy and with interventions being more advanced, carried out more frequently and more expensive today compared with previous years [28,32]. This reflects the increase in portion of gross national product (GNP) offered to health care between 2005 with 9.1 % of GNP to 9.5 % in 2010 [33]. This trend can also be interpreted in Figure 4.

The issue of gender differences in health care has grown in importance in light of recent studies that raises the topic on gender inequalities in several patient populations. For example, a

Swedish, recently published study, describe cost difference between men and women regarding myocardial infarction and appendicitis [34]. When highlighting these differences, differences in health care can therefore be noticed and evaluated and form the basis for health care

improvement. One interesting result presented in this study was that men cost more than women when presenting cost per contact and almost equal numbers over time. The answer to this could be of many reasons; earlier studies as well as the Swedish vascular register (SwedVasc), a register on cardiovascular conditions and statistics, indicates that CI is more commonly

diagnosed amongst men [19,35] whilst CLL is more likely to occur in women [3,15-17,36-37]. This is a liable outcome even in this study as the study population is equivalent to a great amount of PAD patients in Östergötland County. This study presents information on health care costs subdivided into different types of health care admissions. Women are shown to seek medical

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treatment more often than men; one factor could be that women tend to live longer [9] and offered more conservative therapy due to more permanent damage to their limbs. Table 1 illustrates a higher number of women in age group > 85 years (p-value 0.0001) which may reflect reality. Another reason could be that symptoms of women are misinterpreted as arthritis or osteoporosis, also, women seem to seek medical care later in progression of disease than men and are therefore more often in need of limb amputation earlier in health care contact than men, which decreases hospitalization events [17]. This could also indicate that women show atypical symptoms which delays time to diagnose. As several studies show that prevalence of PAD is higher in women [9,15].

There are well-known limitations to this study. First, lack of data on co-morbidities making analyses of cost differences difficult, thus leaving to speculation. Risk factors and underlying disease such as diabetes, hypertension and smoking must be considered when analysing costs [34]. Second, the costs presented are only divided into type of health care appointments. No data on costs of interventions is shown, this could help to analyse treatment patterns regarding

possible gender differences in conservative or surgical interventions. Finally, the strength in number of patients in this study cohort is hard to value. Östergötland County was chosen as a possible model for PAD patients in total in Sweden as participating rates in the KPP database were high in this region. However, there may be several unreported PAD patients especially in outpatients were health contacts not always receive a diagnose code as hospitalization do. If these 3765 patients correspond to total Swedish PAD-population remains unclear. To answer these questions, further studies must be undertaken.

To date, to our knowledge, this study presents data never before investigated. The data is robust, furthermore, costs are solid figures, which make the precision of the results definitive and reliable. In addition, the function of medical registers in Sweden is solid as well as the registry participation from many Swedish hospitals. The KPP-register is one of many validated registers and the study cohort enrolled for this study is all represented in this database, as level of

participation here is high [30]. When analysing costs, the gender perspective was taken into account. To identify health care costs is of highest interest; as the life expectancy increases, diabetes and obesity are predicted to grow [38], knowledge about PAD, its consequences and costs is crucial for evaluating and planning the health economic future in Sweden and to evolve preventive care to imped development of cardiovascular disease and to optimize treatment.

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5. CONCLUSION  

When estimating PAD related health care costs, results present a minor cost difference between genders related to PAD health care when analysing individual health care appointments.

However, in total, men and women seem to cost equally when health care contacts are merged over time. As the health care costs associated with PAD are expected to increase the up coming years, further health economic analyses need to be performed for the best health decisions to be made how to improve treatment of these patients and for sustainable quality assurance in PAD health care.

6. ACKNOWLEDGEMENTS  

I would like to thank my supervisor Dr. Birgitta Sigvant for your knowledge, guidance and the great amount of support throughout this process. Also thank you to Dr. Antonio Pereira Filho for helping me gathering data and for taking time from your busy schedule.

                                 

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7. REFERENCES

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26. Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004 Aug 10;110(6):738-43

27. Gebauer K, Engelbertz C, Malyar NM, Meyborg M, Lüders F, Freisinger E et. al. Long-Term Mortality After Invasive Angiography and Endovascular Revascularization in Patients With PAD Having Chronic Kidney Disease. Angiology. 2015 Aug 30.

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36. Criqui MH, Fronek A, Barrett-Connor E, Klauber MR, Gabriel S, Goodman D. The prevalence of peripheral arterial disease in a defined population. Circulation.1985 Mar;71(3):510-5.

 

37. Kolossváry E, Ferenci T, Kováts T, Kovács L, Járai Z, Menyhei G, et al. Trends in Major Lower Limb Amputation Related to Peripheral Arterial Disease in Hungary: A Nationwide Study (2004-2012). Eur J Vasc Endovasc Surg. 2015 Jul;50(1):78-85.

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Ethical  considerations  

 

Ethics  are  an  important  subject  when  it  comes  to  research  and  scientific  studies.  These   considerations  make  up  the  framework  in  which  research  can  be  performed.    As  humans   and  sometimes  animals  are  involved  in  several  experiments,  consideration  on  the  topic  of   ethics  is  central  when  it  comes  to  safety  and  health  for  example.  The  research  should  be   performed  with  good  intentions,  and  in  some  way  lead  to  a  positive  result.  The  ethical   “rules”  are  crucial  during  the  entire  process,  from  brainstorming  research  projects  to   methods,  study  design  and  in  writing.  All  scientific  projects  must  be  ethically  approved   before  execution,  however,  in  this  specific  project  entitled  “Peripheral  Arterial  Disease  –a   descriptive  study  from  a  gender  perspective”,  the  study  design  allows  research  without   ethical  consent.  As  it  is  a  descriptive  study  without  journal  reviews  and  no  personal  data  is   included,  an  ethical  consideration  is  not  relevant.    

 

Maintaining  anonymity  of  test  individuals  is  often  a  goal  in  the  research  area.  Also,  to   maintain  integrity  with  the  study  population  is  often  of  great  interest  when  handling   surveys  etc.  Also,  to  implement  your  study,  one  has  to  ask  for  permission.  Participating   individuals  in  a  specific  project  must  be  offered  informed  consent  when  initiating  project   and  should  be  able  to  leave  the  experiment  if  they  do  not  want  to  proceed.    

 

Ethical  considerations  can  be  seen  from  an  individual-­‐  or  from  a  group  perspective.  How  is   the  aim  of  this  study  affecting  the  participants?  On  an  individual  basis,  or  in  a  group  

perspective?  The  focus  for  ethical  studies  is  to  obtain  a  positive  outcome  for  society  in   general.  The  participants  have  to  be  protected  from  potential  risks  of  experiment.    

Research  must  be  based  on  former  studies  and  knowledge  on  the  subject  to  indicate  new   studies  and  projects  and  the  risk  should  not  exceed  the  benefit  of  the  study.  

 

Rebecka  Wästgård,    

Bachelor  degree  (major  in  medicine)   Örebro  University.  

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Rebecka  Wästgård   Dept.  of  Medicine  

Örebro  University,  Sweden   Fakultetsgatan  1  

702  81,  Örebro,  Sweden   Tel:  +46(0)  76  260  87  64  

E-­‐mail:  rebwah111@studentmail.oru.se    

Letter  of  intent  

January  7,  2016   Dr.  Vasc    

Editor  in  chief,  Journal  of  Vascular  Surgery    

Dear  editor,      

Attached  to  this  paper  I  would  like  to  submit  the  manuscript  entitled-­‐  ”Peripheral  Arterial   Disease  (PAD)-­‐  a  descriptive  study  with  a  gender  perspective”  to  be  considered  for  

publication  in  the  Journal  of  Vascular  Surgery.      

This  descriptive  cost  study  presents  health  care  costs  from  3675  PAD-­‐patients  in  

Östergötland  County,  data  never  before  investigated  and  analysed  and  therefore  I  believe  is   of  highest  interest  to  be  elucidated  in  your  journal.  

 

The  study  indicates  presence  of  gender  inequalities  in  health  economic  in  PAD-­‐related  care.   It  is  important  to  highlight  this  topic  in  medical  journals,  as  awareness  in  clinicians  and   researchers  can  prevent  inequality  in  health  care  between  men  and  women  and  for  quality   assurance  in  treatment  of  these  individuals,  and  additionally,  maintain  the  sustainability  in   health  economics.      

 

This  study  is  original  and  is  not  being  published  elsewhere.     Sincerely,    

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PRESSMEDDELANDE  

 

-­‐  ”Nya  data  gällande  hälsovårdskostnader  för  perifer  benartärsjukdom  

pekar  mot  kostnadsskillnader  mellan  män  och  kvinnor”.  

 

Benartärsjukdom  (BAS)  är  ett  mycket  vanligt  tillstånd  globalt  och  är  en  av  de  mest   kostsamma  kardiovaskulära  sjukdomarna.  Tillståndet  leder  till  kraftigt  sänkt  livskvalitet   för  patienterna  med  smärta,  funktionsnedsättning  samt  hotande  amputationsrisk.  BAS  har   även  en  stark  koppling  till  senare  utveckling  av  kardio-­‐  samt  cerebrovaskulära  tillstånd   som  stroke  och  hjärtinfarkt  med  en  ökad  dödlighet  som  följd.  

 

Nu  har  en  studie  genomförts  vid  Örebro  Universitet  i  samarbete  med  kirurgiska  kliniken  på   Centralsjukhuset  i  Karlstad  där  man  uppskattat  BAS-­‐relaterade  hälsovårdskostnader  och   sedan  analyserat  dessa  från  ett  genusperspektiv.  Mellan  2005-­‐2010  valdes  3675  patienter   från  Östergötlands  län  med  BAS  som  primär  diagnoskod  ut  och  delades  in  i  åldersgrupper   och  efter  kön.  Kostnader  inhämtades  från  KPP-­‐registret  (kostnad  per  patient),  ett  svenskt   individbaserat  register  som  är  väl  validerat.    

 

Resultat  visar  att  män  kostar  mer  än  kvinnor  när  man  tittar  på  en  enskild  vårdkontakt.   Kostnadsanalys  av  samtliga  vårdkontakter  under  sexårsperioden  visar  dock  att  män  och   kvinnor  kostar  lika  mycket.  Hur  kan  detta  komma  sig?  Studien  tar  upp  olika  typer  av   vårdkontakter  så  som  läkarbesök,  sjuksköterskebesök  eller  enbart  en  telefonkontakt.  Man   kan  då  se  att  kvinnor  söker  vård  i  större  utsträckning  än  män,  och  dessa  i  sin  tur,  har  färre   besök,  men  dyrare  kontakter.  Orsaken  till  detta  kan  vara  många.  Bakomliggande  sjukdom   hos  patienter  bör  tas  i  beaktande  när  dessa  data  analyseras  för  att  kunna  svara  på  frågan.      

Att  analysera  kostnader  från  ett  könsperspektiv  leder  till  att  förekomst  av  ojämlik  vård  tas   upp  till  ytan  och  ger  möjlighet  till  förbättringsarbete  inom  hälso-­‐  och  sjukvård.  Ämnet  står   högt  på  agendan  då  ett  flertal  tidigare  studier  pekat  åt  samma  håll  gällande  andra  

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vårdkostnaderna  presenteras  och  kan  stå  till  grund  för  en  mer  effektiv  och  hållbar   hälsoekonomi  i  Sverige.    

 

 

References

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