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Introduction Opioid-induced constipation (OIC) is a common and costly side effect of opioid treatment affecting patients’ quality of life (QoL). The combination oxycodone/naloxone reduces OIC while providing effective analgesia in patients with moderate to severe pain. The objective of this observational study was to compare health-related quality of life (HRQoL), healthcare resource use, and costs in patients with severe pain who were initially treated with oxycodone and laxatives and then subsequently switched to treatment with oxycodone/naloxone. Methods Data were collected by means of questionnaires completed by patients with OIC before and after the initiation of oxycodone/naloxone treatment at different clinical centers in Sweden. The questionnaires included questions on healthcare resource use and absence from work and also consisted of the Patient Assessment of Constipation-QoL (PAC-QoL) instrument, the EuroQol five dimensions questionnaire (EQ‐5D), the Patient Assessment of Constipation Symptoms (PAC-SYM) instrument, and the Bowel Function Index (BFI). Results The analysis included 37 patients. Resource utilization was lower after treatment with oxycodone/naloxone, in terms of both the number of healthcare contacts and the purchases of medicine for the treatment of constipation. According to the BFI score, patients had fewer problems with OIC after the initiation of oxycodone/naloxone. The PAC-QoL score showed a positive change for patients in both the 96-point dissatisfaction index and the 16-point satisfaction index. PAC-SYM scores was lower after the initiation of oxycodone/naloxone treatment, indicating fewer constipation-related problems. Conclusion Treatment with oxycodone/naloxone had an overall positive effect on patients, consisting mainly of decreasing the severity of the constipation problems, increasing HRQoL, and decreasing the use of healthcare resources. Funding: Mundipharma AB, Gothenburg, Sweden.

Introduction Trastuzumab is part of the standard treatment for HER2-positive breast cancer. The aim of this study was to estimate the societal value of trastuzumab administered through subcutaneous (SC) injection compared to intravenous (IV) infusion. Methods Female patients with HER2-positive breast cancer receiving SC or IV trastuzumab were consecutively enrolled from five Swedish oncology clinics from 2013 to 2015. Data on time and resource utilization was collected prospectively using patient and nurse questionnaires. Societal costs were calculated by multiplying the resource use by its corresponding unit price, including direct medical costs (pharmaceuticals, materials, nurse time, etc.), direct non-medical costs (transportation) and indirect costs (production loss, lost leisure time). Costs were reported separately for patients receiving trastuzumab for the first time and non-first time (“subsequent treatment”). Results In total, 101 IV and 94 SC patients were included in the study. The societal costs were lower with SC administration. For subsequent treatments the cost difference was €117 (IV €2099; SC €1983), partly explained by a higher time consumption both for nurses (14 min) and patients (23 min) with IV administration. Four IV and 16 SC patients received trastuzumab for the first time and were analysed separately, resulting in a difference in societal costs of €897 per treatment. A majority of patients preferred SC to IV administration. Conclusion SC administration resulted in both less direct medical costs and indirect costs, and was consequently less costly than IV administration from a societal perspective in a Swedish setting.

Resource use and costs for topical treatment of hard-to-heal ulcers based on data from the Swedish Registry of Ulcer Treatment (RUT) were analysed in patients recorded in RUT as having healed between 2009 and 2012, in order to estimate potential cost savings from reductions in frequency of dressing changes and healing times. RUT is used to capture areas of improvement in ulcer care and to enable structured wound management by registering patients with hard-to-heal leg, foot and pressure ulcers. Patients included in the registry are treated in primary care, community care, private care, and inpatient hospital care. Cost calculations were based on resource use data on healing time and frequency of dressing changes in Swedish patients with hard-to-heal ulcers who healed between 2009 and 2012. Per-patient treatment costs decreased from SEK38 223 in 2009 to SEK20 496 in 2012, mainly because of shorter healing times. Frequency of dressing changes was essentially the same during these years, varying from 1·4 to 1·6 per week. The total healing time was reduced by 38%. Treatment costs for the management of hard-to-heal ulcers can be reduced with well-developed treatment strategies resulting in shortened healing times as shown in RUT.

OBJECTIVE Infection commonly complicates diabetic foot ulcers and is associated with a poor outcome. In a cohort of individuals with an infected diabetic foot ulcer, we aimed to determine independent predictors of lower-extremity amputation and the predictive value for amputation of the International Working Group on the Diabetic Foot (IWGDF) classification system and to develop a risk score for predicting amputation. RESEARCH DESIGN AND METHODS We prospectively studied 575 patients with an infected diabetic foot ulcer presenting to 1 of 14 diabetic foot clinics in 10 European countries. RESULTS Among these patients, 159 (28%) underwent an amputation. Independent risk factors for amputation were as follows: periwound edema, foul smell, (non)purulent exudate, deep ulcer, positive probe-to-bone test, pretibial edema, fever, and elevated C-reactive protein. Increasing IWGDF severity of infection also independently predicted amputation. We developed a risk score for any amputation and for amputations excluding the lesser toes (including the variables sex, pain on palpation, periwound edema, ulcer size, ulcer depth, and peripheral arterial disease) that predicted amputation better than the IWGDF system (area under the ROC curves 0.80, 0.78, and 0.67, respectively). CONCLUSIONS For individuals with an infected diabetic foot ulcer, we identified independent predictors of amputation, validated the prognostic value of the IWGDF classification system, and developed a new risk score for amputation that can be readily used in daily clinical practice. Our risk score may have better prognostic accuracy than the IWGDF system, the only currently available system, but our findings need to be validated in other cohorts.

Topical treatments in dermatology can be long, complex and lead to nonadherence and nonpersistence to prescribed treatment. Clinical efficacy observed in randomized clinical trials (RCT) may therefore be reduced in real-world clinical practice. The objective of this study was to analyze patient-reported treatment adherence, treatment satisfaction and health-related quality of life (HRQoL) with topical treatments of actinic keratosis (AK) in routine clinical practice in Denmark and Sweden. Adult patients prescribed field-directed topical AK treatments with diclofenac gel, imiquimod or ingenol mebutate per routine clinical practice were eligible for the observational RAPID-ACT study. Data were collected through physician and patient questionnaires that included validated instruments to measure treatment satisfaction (TSQM-9), treatment adherence (MMAS) and HRQoL (EQ-5D-5L, EQ-VAS, AKQoL). In total, 446 patients from Denmark and Sweden were included. Ingenol mebutate patients reported a higher satisfaction with treatment effectiveness compared to patients treated with diclofenac (p =.006) while no other differences in treatment satisfaction could be determined. Treatment adherence was generally high, but higher for ingenol mebutate compared to both diclofenac (p

Aims/hypothesis Outcome data on individuals with diabetic foot ulcers are scarce, especially in those with peripheral arterial disease (PAD). We therefore examined the clinical characteristics that best predict poor outcome in a large population of diabetic foot ulcer patients and examined whether such predictors differ between patients with and without PAD. Methods Analyses were conducted within the EURODIALE Study, a prospective cohort study of 1,088 diabetic foot ulcer patients across 14 centres in Europe. Multiple logistic regression modelling was used to identify independent predictors of outcome (i.e. non-healing of the foot ulcer). Results After 1 year of follow-up, 23% of the patients had not healed. Independent baseline predictors of non-healing in the whole study population were older age, male sex, heart failure, the inability to stand or walk without help, end-stage renal disease, larger ulcer size, peripheral neuropathy and PAD. When analyses were performed according to PAD status, infection emerged as a specific predictor of non-healing in PAD patients only. Conclusions/interpretation Predictors of healing differ between patients with and without PAD, suggesting that diabetic foot ulcers with or without concomitant PAD should be defined as two separate disease states. The observed negative impact of infection on healing that was confined to patients with PAD needs further investigation.

Atopic dermatitis is a chronic skin disorder with high prevalence, especially in the Nordic countries. Effective maintenance therapy during symptom-free episodes may prolong the time to eczema relapse according to a previously published clinical trial. The present study evaluates the cost-effectiveness of a barrier-strengthening moisturizer containing 5% urea, compared with a moisturizer with no active ingredients during eczema-free periods. A health economic microsimulation model, based on efficacy data from the randomized clinical trial, analysed the cost-effectiveness of the barrier-strengthening treatment in Finland, Norway and Sweden. The barrier-strengthening moisturizer was cost-saving compared with the moisturizer with no active ingredients in all 3 countries. The result was confirmed in all but one sensitivity analysis. In conclusion, the barrier-strengthening moisturizer is cost-effective as maintenance therapy for patients with atopic dermatitis compared with a moisturizer with no active ingredients.

Allergic rhinitis is a global illness with a well-recognised impact on quality of life and work performance. Comparatively little is known about the extent of its economic impact on society. The TOTALL study estimates the total cost of allergic rhinitis using a sample representing the entire Swedish population of working age. A questionnaire focused on allergic rhinitis was mailed out to a random population of Swedish residents, aged 18–65 years. Health-care contacts, medications, absenteeism (absence from work) and presenteeism (reduced working capacity at work) were assessed, and the direct and indirect costs of allergic rhinitis were calculated. Medication use was evaluated in relation to the ARIA guidelines. In all, 3,501 of 8,001 (44%) answered the questionnaire, and 855 (24%) of these reported allergic rhinitis. The mean annual direct and indirect costs because of allergic rhinitis were €210.3 and €750.8, respectively, resulting in a total cost of €961.1 per individual/year. Presenteeism represented 70% of the total cost. Antihistamines appear to be used in excess in relation to topical steroids, and the use of nasal decongestants was alarmingly high. The total cost of allergic rhinitis in Sweden, with a population of 9.5 million, was estimated at €1.3 billion annually. These unexpectedly high costs could be related to the high prevalence of disease, in combination with the previously often underestimated indirect costs. Improved adherence to guidelines might ease the economic burden on society.

Diabetic foot problems are common throughout the world, resulting in major economic consequences for the patients, their families, and society. Foot ulcers are more likely to be of neuropathic origin, and therefore eminently preventable, in developing countries, which will experience the greatest rise in the prevalence of type 2 diabetes in the next 20 years. People at greatest risk of ulceration can easily be identified by careful clinical examination of the feet: education and frequent follow-up is indicated for these patients. When assessing the economic effects of diabetic foot disease, it is important to remember that rates of recurrence of foot ulcers are very high, being greater than 50% after 3 years. Costing should therefore include not only the immediate ulcer episode, but also social services, home care, and subsequent ulcer episodes. A broader view of total resource use should include some estimate of quality of life and the final outcome. An integrated care approach with regular screening and education of patients at risk requires low expenditure and has the potential to reduce the cost of health care.

Three methodological approaches were applied to analyze whether the cost-effectiveness of drotrecogin alfa (activated) (Xigris) as an adjunct to standard care compared with standard care alone is a cost-effective alternative for the treatment of Swedish patients with severe sepsis and organ dysfunction. Health-economic model simulations were applied to (1) Swedish treatment pattern data, (2) international trial data and local unit prices, and (3) Swedish local patient data combined with trial age structure to adjust for differences in the age structure between the trial and the Swedish patient sample. The methodological approach had no effect on the overall conclusion that the intervention was cost-effective in the treatment of Swedish patients with severe sepsis and organ dysfunction. However, the cost-effectiveness ratios were sensitive to the approach applied. The results indicate the importance of collecting not only information on local prices but also information about treatment pattern and patient characteristics when conducting country-specific health-economic model applications.

The aim of this study was to estimate costs of treating venous leg ulcers in Sweden and the United Kingdom during 1 year and to quantify costs in different health states. The costs of treating four different types of venous leg ulcers were estimated for 52 weeks by a stochastic health economic model, which simulated resource use data obtained from prospectively collected patient data, expert panels in the two countries, and published scientific literature. The average cost of treating an ulcer varied between 1332 Euro and 2585 Euro in Sweden and from 814 Euro to 1994 Euro in the United Kingdom. Cost of treating large ulcers (>/= 10 cm(2)) of long duration (>/= 6 months) was highest in both countries. Frequency of dressing changes and duration of time for each dressing change were higher in Sweden than in the United Kingdom, resulting in higher total cost per patient in Sweden. An important factor for the total costs was time to heal. Other important variables influencing treatment costs were frequency and duration of dressing changes. Actions to reduce time used for dressing changes and the total time to healing are thus very important in reducing costs spent on treatment of venous leg ulcers in both countries.

Background and aims Chronic pain is a life altering condition and common among elderly persons. The 7-day buprenorphine patch could be a suitable treatment for managing chronic pain of moderate severity in elderly patients in Sweden. The objective of this analysis was to investigate the cost-effectiveness of the 7-day buprenorphine patch, versus no treatment, in patients >50 years old who suffer from moderate pain in a health economic perspective. An additional aim was to evaluate how the cost-effectiveness is affected by the choice of EQ-5D weights. Methods The annual treatment cost and the potential gains in health-related quality of life (HRQoL) of buprenorphine, compared to no treatment, were evaluated. Original EQ-5D data were collected from four clinical reference studies at baseline and at the final visit. Treatment effects on HRQoL were then assessed using both UK and Swedish EQ-5D weights. Annual treatment costs were calculated based on costs of physician visits and pharmaceuticals. The optimal treatment dose was 10-15 μg/h and the analysis was hence performed on both a 10- and a 15 μg/h buprenorphine patch. Results The analysis of buprenorphine treatment resulted in improved HRQoL in all reference studies, irrespective of choice of EQ-5D weight set. The change in quality adjusted life years (QALYs) varied with a gain of 0.042-0.118 using the UK weights and 0.020-0.051 with the Swedish weights. The average annual treatment cost was SEK14454 for the 10μg/h patch and SEK17 017 for the 15 μg/h patch, while cost for the no-treatment alternative was SEK 9 960. The base case incremental cost-effectiveness ratios (ICER) with the UK weights were SEK 40000-SEK 170000 and SEK 90000-SEK 350000 when applying the Swedish weights. The corresponding ICER-span in the sensitivity analysis was SEK 15 000-SEK 400 000 when applying the UK weights and SEK 30 000-SEK 840 000 with the Swedish weights (SEK 100 is about €11). Conclusions The results imply that the 7-day buprenorphine patch may be a cost-effective treatment of moderate chronic pain in patients over 50 years of age. The UK and the Swedish EQ-5D weights generated vastly different HRQoL estimates but buprenorphine remains cost-effective regardless choice of weight set.

Objective: To calculate costs for the management of deep foot infections and to identify the most important factors related to treatment costs. Design: Costs for in-hospital care, surgery, investigations, antibacterials, visits to the foot-care team, orthopaedic appliances and topical treatment were calculated retrospectively from diagnosis until healing or death. Multiple regression analysis was used to identify factors that independently affect costs. Setting: A multidisciplinary foot-care team. Patients: 220 prospectively followed patients with diabetes mellitus and deep foot infections who were referred to the team from 1986 to 1995. Main Outcome Measures and Results: Total cost for healing without amputation was Swedish kronor (SEK)136 600 per patient, while the corresponding cost for healing with minor amputation was SEK260 000 and with major amputation was SEK234 500. All costs were quoted in SEK at 1997 price levels (£1 sterling and $US1 equalled approximately SEK12.50 and SEK7.64, respectively). The cost of antibacterials was 4%of total costs. The cost of topical treatment was 51% of total costs and related to wound healing time. Number of weeks between diagnosis of deep foot infection and healing, and number of surgical procedures were variables that explained 95% of costs in the multiple regression analysis. It was not possible to find any parameters present at diagnosis that could contribute to an explanation of total treatment costs. Conclusions: Topical treatment accounted for the largest proportion of total costs and the most important cost driving factors were wound healing duration and repeated surgery. Costs of antibacterials should not be used as an argument in the choice between early amputation and conservative treatment.

Objective: Recent research has focused on eradication therapy as the principal treatment of patients with duodenal ulcers and Helicobacter pylori infection. The aim of this study was to analyse the cost effectiveness of triple therapy versus 2 dual therapies. Design: A health economic evaluation of triple therapy with lansoprazole, amoxicillin and clarithromycin versus 2 dual therapies (lansoprazole or omeprazole, each with amoxicillin) in the eradication of Helicobacter pylori in patients with duodenal ulcers was performed in parallel with a randomised clinical trial. Direct and indirect costs were estimated for 1 year using data elicited from patient questionnaires and from the clinical trial. Main outcome measures and results: Despite the initial drug cost for triple therapy being 650 Swedish kronor (SEK; 1996 values) higher, the average total direct cost in this group was only SEK150 to SEK200 higher than in the dual therapy groups. This was a result of fewer outpatient visits and lower drug use after treatment failure in the triple therapy group. Triple therapy had a more favourable cost-effectiveness ratio than the dual therapies. Conclusion: In spite of higher initial antimicrobial costs, triple therapy with lansoprazole, amoxicillin and clarithromycin is more cost effective than dual therapy because of a higher eradication rate and greater symptom relief.

Biological drugs are expensive, but can reduce symptoms and increase quality of life for patients with psoriasis. The aim of this study was to examine quality of life, disease severity and treatment satisfaction in Danish, Finnish and Swedish patients with psoriasis. Based on 12 months’ data from patient surveys and chart reviews, 3 treatment groups were identified: topical, systemic and/ or biological < 12 months, and biological for 12 months. Regression analyses were performed to investigate influence on treatment satisfaction, disease problems and quality of life. Patients treated with biological drugs for 12 months showed the highest treatment satisfaction and the lowest Dermatology Life Quality Index score. A number of patients with topical treatment reported low quality of life, severe or very severe disease problems, and low treatment satisfaction. Some patients with psoriasis may be under-treated and might benefit from a more aggressive treatment strategy. It is important, however, that resource utilization is optimized and patients are not treated with more advanced agents than necessary. Key words: psoriasis; quality of life; biological treatment.

BACKGROUND: Acute rhinosinusitis is a common disease with an increasing incidence rate. It causes substantial costs to the individual and to society through healthcare consumption and absence from work. The use of antibiotics is widespread in the treatment of acute rhinosinusitis, but increasing bacterial resistance is an argument for restricting excessive use of antibiotics. AIMS: The aim of this study was to analyse the cost-effectiveness of mometasone furoate nasal spray (MFNS) compared with amoxicillin or non-active treatment of mild to moderate acute rhinosinusitis in a Swedish setting. METHODS: A cost-effectiveness model was developed to capture the costs and health-related quality of life (HRQoL) over a 15-day period. Acute rhinosinusitis was modelled as changes in the Major Symptom Score. The model takes on a societal perspective in a Swedish setting. Efficacy data were taken from a randomised clinical study. The model has three treatment arms: (A) MFNS 200μg twice daily, (B) amoxicillin 500mg three times daily, and (C) placebo. Information about resource utilisation and HRQoL was taken from a recent observational study. RESULTS: Costs were reduced and quality-adjusted life years were increased with MFNS 200μg twice daily compared with amoxicillin 500mg three times daily. MFNS was cost-saving or cost-effective compared with amoxicillin or non-active treatment in the sensitivity analyses regardless of the HRQoL measurement used. CONCLUSIONS: This study shows that treatment with MFNS 200μg twice daily results in lower costs and improved HRQoL in acute rhinosinusitis compared with amoxicillin or self-medication.

Objectives. To perform an economic analysis of primary healing and healing with amputation in diabetic patients with foot ulcers. Design. A retrospective economic analysis based on a prospective study of consecutively presenting diabetic patients admitted to the Department of Internal Medicine because of foot ulcer. Setting. A multidisciplinary foot-care team. Subjects. A total of 314 consecutively presenting diabetic patients with foot ulcers. Forty patients died before healing occurred. In those patients who healed primarily (n = 197) or after amputation (n = 77), a retrospective economic analysis was performed. Interventions. All patients were treated by a multi-disciplinary foot care team consisting of diabetologist, orthopaedic surgeon, diabetes nurse, podiatrist and orthotist both as in- and out-patients. The patients were followed by the team from admittance until final outcome, i.e. primary healing or healing with amputation or death. Main outcome measures. Data from both the prospectively collected patient material and from patient records were used to estimate the cost for hospital care, antibiotics, surgery, out-patient care, staff attendance, drugs and material for ulcer dressings, and orthopaedic appliances. Results. The total costs were SEK 51000 (3000–808000) for patients with primary healing and SEK 344000 (27000–992000) for healing with amputation. Costs for in-patient care were 37% of total average costs for primary healing and 82% for patients with amputation. The costs for topical treatment of the ulcers in out-patient care were 45% of the total average cost for primary healed and 13% for patients who healed with amputation. The costs for products used for ulcer dressings were 21% of total costs for topical treatment, i.e. 9% and 3% of total average costs for primary healing and healing with amputation, respectively. Costs for visits to the foot care team, antibiotics and orthopaedic appliances were low in relation to total costs. Conclusion. Treatment of diabetic patients with foot ulcers in a multidisciplinary system was associated with relatively low costs. Healing with amputation was associated with high costs mainly due to multiple and extended hospitalization. These findings indicate the potential cost savings of preventive and multi-disciplinary foot care.

The direct and indirect costs of acute myeloid leukemia were estimated for Sweden in 1989. The calculated total cost was SEK 460 million. Nearly half of the costs, or 1.7 million per patient diagnosed, were indirect costs due to premature mortality. Direct costs of relapses and indirect costs of mortality represent costs due to the absence of completely curable therapy. They also represent potential cost savings that could be ootained after introduction of new treatment options in the future.

Patient registries often lack indicators of the disease as experienced by patients, e.g. treatment satisfaction and self-assessed disease severity. There is scarce information about the relationship between these assessments and currently existing instruments used in treatment evaluation. Our objective was to explore the importance of these indicators among patients with psoriasis in Finland and Sweden, in relation to treatment patterns and current measures of health-related quality of life. Data were collected from a patient survey and a retrospective chart review for 273 patients over 12 months. To assess psoriasis treatment completely, it is necessary to consider the impact of the disease on the patient in terms of treatment satisfaction, disease severity and health-related quality of life. The individual disease burden on patients should play a central role in formulating treatment goals. Clinician- and patient-based perspectives of the overall impact of psoriasis can assist clinical decision-making and evaluations of treatments.

Economic appraisal of pharmaceuticals is becoming increasingly important. In a retrospective study of patient records from 58 organ or bone marrow-transplanted patients with systemic mycoses, the cost-effectiveness of treatment with a liposomal amphotericin B formulation was compared with that of conventional amphotericin B. Treatment with liposomal amphotericin B results in fewer adverse reactions, increased life expectancy and higher costs than treatment with conventional amphotericin B. Pricing liposomal amphotericin B at about SKE6000 per patient treatment day will result in an additional cost per life-year gained of about SEK150 000 relative to that using conventional amphotericin B for patients receiving kidney, kidney and pancreas, or pancreas transplants. For liver and bone marrow transplant (BMT) recipients the marginal cost-effectiveness ratio was about SEK195 000 and SEK150 000 per life-year gained. Compared with alternative use of resources in society and health care, use of liposomal amphotericin B rather than conventional amphotericin treatment can be considered cost-effective at the price assumed.

Aims To determine current management and to identify patient-related factors and barriers that influence management strategies in diabetic foot disease. Methods The Eurodiale Study is a prospective cohort study of 1232 consecutive individuals presenting with a new diabetic foot ulcer in 14 centres across Europe. We determined the use of management strategies: referral, use of offloading, vascular imaging and revascularization. Results Twenty-seven percent of the patients had been treated for > 3 months before referral to a foot clinic. This varied considerably between countries (6-55%). At study entry, 77% of the patients had no or inadequate offloading. During follow-up, casting was used in 35% (0-68%) of the plantar fore- or midfoot ulcers. Predictors of use of casting were male gender, large ulcer size and being employed. Vascular imaging was performed in 56% (14-86%) of patients with severe limb ischaemia; revascularization was performed in 43%. Predictors of use of vascular imaging were the presence of infection and ischaemic rest pain. Conclusion Treatment of many patients is not in line with current guidelines and there are large differences between countries and centres. Our data suggest that current guidelines are too general and that healthcare organizational barriers and personal beliefs result in underuse of recommended therapies. Action should be undertaken to overcome these barriers and to guarantee the delivery of optimal care for the many individuals with diabetic foot disease.

This article describes the rationale and protocol of a large data collection study in patients with new diabetic foot ulcers by the Eurodiale study group, a consortium of centers of expertise in the field of diabetic foot disease within Europe. This study is a multicenter, observational, prospective data collection study. Its main aim is to determine the major factors determining clinical outcome and outcome in terms of health-related quality of life and health care consumption. Between September 1, 2003, and October 1, 2004, in 14 European centers, all consecutive patients with diabetes and a new foot ulcer were included in the study and followed until the end point or for a maximum of 1 year. End points were healing of the foot, major amputation, or death. Data were collected on patient, foot, and ulcer characteristics and on diagnostic and management procedures. Furthermore, data were collected on health care organization, quality of life, and resource use. A total of 1232 patients were included in the study. Sixty-three percent of the patients were referred by their general practitioner or were self-referrals. Twenty-seven percent of the patients were admitted at the time of inclusion; 1088 patients were followed until the end point. “Optimal Organization of Health Care in Diabetic Foot Disease” is one of the first large multicenter studies in the field of diabetic foot disease on clinical presentation, clinical outcome, quality of life, resource utilization, and health care organization and their interrelationships. These data will provide us with new insights that enable us to improve care for these patients and guide the development of new studies in this area. The results of this study are the subject of a separate presentation.

Lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) are a common condition in men, and their incidence increases with age. The objective of this study was to evaluate the potential cost-utility of microwave thermotherapy, specifically the ProstaLund Feedback Treatment (PLFT), versus alpha-blockade in Swedish patients with LUTS due to BPH.A health-economic simulation model, based on long-term disease progression and costs, was developed to analyse the cost-utility of PLFT in comparison with alpha-blockade over a 3-year period based on data from published literature, treatment programmes and official price lists. Outcome measures used in the analysis were quality of life, survival and reduction in International Prostate Symptom Score. Sensitivity analyses were performed for a number of essential variables. The perspective of the study is the healthcare sector. All costs are expressed as 2003 prices.Three years after an intervention with PLFT or initiation of drug treatment the cost-utility of PLFT was estimated at approximately euro 6600-9500 per quality-adjusted life-year gained. The cost-utility was further improved over a longer time period, and PLFT appears to be cost-saving after 5 years. One important finding from the model simulation was that PLFT also seems to be favourable in patients with less pronounced symptoms. This result may be further validated when additional results from controlled clinical trials become available.The present model simulation indicates that treatment with PLFT seems to be cost-effective compared with drug therapy with alpha-blockade. The result shows that the time-frame of the analysis has a great impact on the cost-effectiveness ratio.

Annual costs for the treatment of venous leg ulcers in Sweden have been estimated at between SEK 17,000 and SEK 26,500 per patient in 2002 prices. The calculation was based on a model simulation including data from a follow-up of patients in clinical practice, an expert panel, and published literature. The variation in costs depends on ulcer size and ulcer duration when treatment is initiated. The highest costs were estimated for a group of patients with ulcers 10 cm2 or larger and ulcer duration of 6 months or longer. About 50 per cent of the total annual costs were related to staff costs for dressing changes.

Diabetic foot complications result in huge costs for both society and the individual patients. Few reports on the health-economic consequences of diabetic foot infections have been published. In studies considering a wide societal perspective, costs of antibiotics were relatively low, whereas total costs for topical treatment were high relative to the total costs of foot infections. Total direct costs for healing of infected ulcers not requiring amputation are approximately 17,500 dollars (in 1998 US dollars), whereas the costs for lower-extremity amputations are approximately 30,000 dollars-33,500 dollars depending on the level of amputation. Prevention of foot ulcers and amputations by various methods, including patient education, proper footwear, and foot care, in patients at risk is cost effective or even cost saving. Awareness of the potential influence of reimbursement systems on prevention, management, and outcomes of diabetic foot lesions has increased. Despite methodological obstacles, modeling studies are needed in future health-economic evaluations to determine the cost effectiveness of various strategies.

Weekly resource use data for local wound treatment was collected from a clinical survey (138 patients). Annual costs were calculated from the weekly resource usage multiplied by unit costs and published epidemiological prevalence data for Sweden. The average weekly cost was 101 euro, though it differed depending by ulcer size. The total direct annual cost of venous leg ulcers in Sweden could be estimated at 73 million euro (2002 prices, 1 euro = SEK 9.16) based on a point prevalence of 0.3 percent and 45 percent venous ulcers. Treatment of leg ulcers seems to have improved compared with previous reports, resulting in slightly decreased costs. Nevertheless, the costs are still substantial and the management of these patients requires large resources. A more structured management, more careful selection of dressing products and decreased frequency of dressing changes imply further improvements in wound healing and quality of life for patients and decreased costs for the health care system and for society.

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.

Objective. Patients with pancreatic cancer have only short survival after diagnosis, irrespective of treatment. The aim of this study was to perform a health economic evaluation of present standard treatment (in most cases, palliative treatment in combination with best supportive care) versus palliative treatment with gemcitabine in combination with best supportive care in patients with locally advanced pancreatic carcinoma. Design. The use of resources and associated costs according to present treatment practice were estimated and calculated retrospectively. Costs were calculated from diagnosis until death. Actual costs and treatment effects for the patient population were compared with expected treatment costs for the same population if they additionally received gemcitabine. Setting. This economic analysis is based on a hypothetical comparison and was performed from a societal point of view. Patients and participants. The study population consisted of all patients diagnosed with pancreatic cancer during the year April 1994 to March 1995 and resident in Stockholm County, Sweden. After exclusions, 184 patients were included in the economic analysis. Interventions. The effects of gemcitabine treatment on survival and diseaserelated symptoms were extrapolated from the results of a recent randomised clinical trial in North America. Main outcome measures and results. The estimated additional costs for chemotherapy, treatment of adverse effects and in- and outpatient care associated with gemcitabine treatment were approximately 132 000 Swedish kronor (SEK) per life-year gained. This result is comparable with costs per life-year gained for other accepted treatments, for example those of home dialysis and kidney transplants for chronic renal failure. Conclusions. Treatment with gemcitabine in patients with pancreatic cancer may be a cost-effective alternative, but the results need to be confirmed in future randomised trials.

This study was carried out to investigate the direct costs for treatment of patients with cancer from 1985 to 1996 in Sweden, and to examine health economic effects of changes in treatment pattern. Material for the study was collected from official statistics and from published health economic evaluations of cancer treatment. Costs for inpatient care decreased during the period, while costs for outpatient care and drugs increased. In total, the direct health care costs for cancer treatment decreased from 1985 to 1996. New drugs registered on the market are often more expensive than the drugs they replace. From a health economic perspective it is not clear, however, that higher drug costs necessarily increase total costs. Further health economic research is needed because many treatment alternatives have not yet been evaluated, and furthermore, because a treatment option can be cost effective in one specific indication but not in another.

Chemotherapy treatment of patients with advanced non-small cell lung cancer (NSCLC) has been characterised by low cure rates, serious side effects, and expensive inpatient care. The aim of the present report was to perform an economic evaluation of gemcitabine monotherapy compared with standard chemotherapy treatment for NSCLC stages IIIB and IV. Standard chemotherapy treatment was identified as cisplatin/etoposide and ifosfamide/etoposide. Effectiveness expressed as survival and tumour response rates was assumed to be broadly equivalent for the alternatives. A cost-minimisation analysis was therefore performed. Total costs per patient per first treatment cycle of chemotherapy for the alternatives cisplatin/etoposide, ifosfamide/etoposide and gemcitabine were Skr 15,131, Skr 25,226, and Skr 13,266, respectively. The results are sensitive to whether chemotherapy could be given in inpatient or in outpatient care. Monotherapy with gemcitabine outpatient treatment in patients with stage IIIB and IV NSCLC was found to be a cost saving alternative when compared with currently used inpatient combination regimens. The treatment alternative with gemcitabine appears to be associated with higher costs for drugs and outpatient care, but lower costs for inpatient care and treatment of adverse events.

Foot lesions are common and serious complications in patients with diabetes mellitus. In recent years, several authors have, in addition to the medical aspects, focused on the high costs for treatment of this complication. However, few studies have performed a complete health-economic comparison and analysis of different treatments. This is probably related to the complexity of the problem and ethical difficulties in performing randomised clinical trials on these patients. Despite the lack of comparative health-economic studies, most authors conclude that amputations should be avoided if there is any possibility of saving the limb. This is not only because of the economic consequences-high costs for repeated hospitalisations, rehabilitation, home care and social-service support-associated with amputations, but also the quality-of-life aspects. Alternative treatment options might seem costly in the short term, but most cost-effectiveness analyses that also consider the long term perspective have concluded that treatment alternatives in which the limb is saved are more cost effective. Methodological aspects, such as the perspective of a study, may cause difficulties in comparing results between countries and settings. By using the societal perspective in economic studies, incentives to push costs from one sector to another might be avoided.

The purpose of this study was to analyze long-term costs for foot ulcers in diabetic patients. Patients were treated and followed prospectively by a foot care team. A retrospective economic analysis was performed of costs for 274 patients during 3 years from healing of an initial foot ulcer, with or without amputation. Costs were estimated for inpatient care, outpatient care, home care, and social service. The cost calculations include costs due to complications and disability related to the initial ulcer, costs related to recurrence of ulcer, and costs for prevention of new ulcers. Expected total present value cost per patient during 3 years of observation was $26,700 (U.S. dollars) for primary healed patients with critical ischemia and $16,100 for primary healed patients without critical ischemia. For patients who healed with an amputation, the corresponding costs were $43,100 after a minor amputation and $63,100 after a major amputation. When estimating the costs for diabetic foot ulcers, it is not sufficient to calculate short-term costs. Long-term costs are high, mainly due to the need for increased home care and social service, but also due to costs for recurrent ulcers and new amputations.

Background Actinic keratosis (AK) is a common skin condition that may progress to non-melanoma skin cancer (NMSC). The disease may influence Health Related Quality of Life (HRQoL), but studies of HRQoL in patients with AK are limited. The purpose of the study was to analyze HRQoL in patients with different severity levels of AK treated in dermatology specialist care using generic and disease-specific HRQoL instruments and to analyze their relationship. Methods AK patients who visited dermatological clinics in Denmark were included in an observational, cross-sectional, study in a multi-center setting. Dermatologists assessed AK severity and patients completed: Actinic Keratosis Quality of Life Questionnaire (AKQoL), Dermatology Life Quality Index (DLQI), and EQ-5D-5 L including EQ-VAS. Differences between categorical subgroups were tested with Wilcoxon rank-sum test. The relationship between instruments was analyzed with the Spearman correlation test. Results A total of 312 patients were included in the analyses. Patients reported impairment in the disease specific HRQoL instrument AKQoL (mean AKQoL 6.7, DLQI 2, EQ-5D-5 L 0.88, and EQ-VAS 79). HRQoL was least affected in patients with mild actinic disease, whereas patients with severe actinic damage suffered from further impaired HRQoL (mean AKQoL 10.1 and DLQI 4.6). Correlations between DLQI and AKQoL were moderate, whereas the correlations between DLQI and EQ-5D-5 L and between AKQoL and EQ-5D-5 L were weak. Conclusions Patients with severe actinic damage showed more impairment in HRQoL than those with mild disease. Correlations between instruments suggest that they are complementary as they measure different aspects of HRQoL and are used for different purposes.