A cost analysis of introducing an infectious disease specialist-guided antimicrobial stewardship in an area with relatively low prevalence of antimicrobial resistance.

BACKGROUND: Antimicrobial stewardship programs have been widely introduced in hospitals as a response to increasing antimicrobial resistance. Although such programs are commonly used, the long-term effects on antimicrobial resistance as well as societal economics are uncertain. METHODS: We performed a cost analysis of an antimicrobial stewardship program introduced in Malmö, Sweden in 20 weeks 2013 compared with a corresponding control period in 2012. All direct costs and opportunity costs related to the stewardship intervention were calculated for both periods. Costs during the stewardship period were directly compared to costs in the control period and extrapolated to a yearly cost. Two main analyses were performed, one including only comparable direct costs (analysis one) and one including comparable direct and opportunity costs (analysis two). An extra analysis including all comparable direct costs including costs related to length of hospital stay (analysis three) was performed, but deemed as unrepresentative. RESULTS: According to analysis one, the cost per year was SEK 161 990 and in analysis two the cost per year was SEK 5 113. Since the two cohorts were skewed in terms of size and of infection severity as a consequence of the program, and since short-term patient outcomes have been demonstrated to be unchanged by the intervention, the costs pertaining to patient outcomes were not included in the analysis, and we suggest that analysis two provides the most correct cost calculation. In this analysis, the main cost drivers were the physician time and nursing time. A sensitivity analysis of analysis two suggested relatively modest variation under changing assumptions. CONCLUSION: The total yearly cost of introducing an infectious disease specialist-guided, audit-based antimicrobial stewardship in a department of internal medicine, including direct costs and opportunity costs, was calculated to be as low as SEK 5 113.

Cost consequences due to reduced ulcer healing times - analyses based on the Swedish Registry of Ulcer Treatment.

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.

Treatment patterns, treatment satisfaction, severity of disease problems, and quality of life in patients with psoriasis in three Nordic countries.

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.

Patient-reported outcomes in topical field treatment of actinic keratosis in Swedish and Danish patients.

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 < .001) and imiquimod (p = .007), possibly due to shorter treatment duration. No differences in improved HRQoL were found. More research is needed about the link between treatment adherence and real-world effectiveness.

The global burden of diabetic foot disease.

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.

Treatment of Severe Pain and Opioid-induced Constipation: An Observational Study of Quality of Life, Resource Use, and Costs in Sweden.

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.

Societal cost of subcutaneous and intravenous trastuzumab for HER2-positive breast cancer - An observational study prospectively recording resource utilization in a Swedish healthcare setting.

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.

[Treatment of venous leg ulcers is costly for the health care and the society. The value of preventive measures should be further investigated according to a study]. / Behandling av venösa bensår kostsamt för sjukvård och samhälle. Värdet av förebyggande insatser måste utredas mer, visar studie.

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.

Predictors of lower-extremity amputation in patients with an infected diabetic foot ulcer.

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.

Health-economic consequences of diabetic foot lesions.

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.

Health-related quality of life predicts major amputation and death, but not healing, in people with diabetes presenting with foot ulcers: the Eurodiale study.

OBJECTIVE: Low health-related quality of life (HRQoL) has been consistently reported to be associated with poor prognosis for a variety of health outcomes in various settings. We aimed to evaluate whether HRQoL in patients presenting with new diabetic foot ulcers (DFUs) has prognostic significance for ulcer healing, major amputation, and death. RESEARCH DESIGN AND METHODS: We followed 1,088 patients with new DFUs presenting for treatment at one of the 14 centers in 10 European countries participating in the Eurodiale (European Study Group on Diabetes and the Lower Extremity) study, prospectively until healing (76.9%), major amputation (4.6%), or death (6.4%) up to a maximum of 1 year. At baseline, patient and ulcer characteristics were recorded as well as EQ-5D, a standardized instrument consisting of five domains and a visual analog scale for use as a measure of HRQoL. The prognostic influence of the EQ-5D domains was evaluated in multivariable Cox regression analyses on the time-to-event data, adjusting for baseline clinical characteristics of the ulcer and comorbidities. RESULTS: While predictive effects of HRQoL, adjusted for possible confounders, were absent for healing, decreased HRQoL, especially in the physical domains, was statistically significant for major amputation (mobility, self-care, usual activities) and death (self-care, usual activities, pain/discomfort). CONCLUSIONS: Low HRQoL appears to be predictive for major amputation and death, but high HRQoL does not increase healing. Future studies into the influence of HRQoL on ulcer outcome are important in attempts to decrease treatment failure and mortality.

Under what conditions is feedback microwave thermotherapy (ProstaLund Feedback Treatment) cost-effective in comparison with alpha-blockade in the treatment of benign prostatic hyperplasia and lower urinary tract symptoms?

OBJECTIVE: 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. MATERIAL AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 of treatment for venous leg ulcers in Sweden and the United Kingdom.

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.