Translating 'See-and-Treat' to primary care: opening the gates does not cause a flood.

OBJECTIVE: To explore how the See-and-Treat concept can be applied in primary care and its effect on volume and productivity. DESIGN: An explanatory single-case study design with a mixed methods approach and presented according to the SQUIRE 2.0 guidelines. SETTING: A publicly-funded, private primary care provider within the Stockholm County, which caters to a diverse patient population in terms of ethnicity, religion, socioeconomic status and care needs. PARTICIPANTS: CEO, center manager, four physicians, two licensed practical nurses, one medical secretary and one lab assistant. INTERVENTION: A See-and-Treat unit was established to offer same-day service for acute unplanned visits. Standardized patient symptom forms were created that allowed patients to self-triage and then enter into a streamlined care process consisting of a quick diagnostic lab and a physician visit. MAIN OUTCOME MEASURES: Volume, productivity, staff perceptions and patient satisfaction were measured through data on number and type of contacts per 1000 listed patients, visits per physician, observations, interviews and a questionnaire. RESULTS: A significant decrease in the acute and total number of visits, a continued trend of diminishing telephone contacts, and a non-significant increase in physician productivity. Patients were very satisfied, and staff perceived an improved quality of care. CONCLUSIONS: See-and-Treat appears to be a viable approach for a specific primary care patient segment interested in acute same-day-service. Opening up access and standardizing care made it possible to efficiently address these needs and engage patients.

Congenital heart defect repair with ADAPT tissue engineered pericardium scaffold: An early-stage health economic model.

OBJECTIVE: The objective of this study was to evaluate the cost effectiveness of tissue engineered bovine tissue pericardium scaffold (CardioCel) for the repair of congenital heart defects in comparison with surgery using xenogeneic, autologous, and synthetic patches over a 40-year time horizon from the perspective of the UK National Health Service. METHODS: A six-state Markov state-transition model to model natural history of disease and difference in the interventional effect of surgeries depending on patch type implanted. Patches differed regarding their probability of re-operation due to patch calcification, based on a systematic literature review. Transition probabilities were based on the published literature, other clinical inputs were based on UK registry data, and cost data were based on UK sources and the published literature. Incremental cost-effectiveness ratio (ICER) was determined as incremental costs per quality adjusted life years (QALY) gained. We used a 40-year analytic time-horizon and adopted the payer perspective. Comprehensive sensitivity analyses were performed. RESULTS: According to the model predictions, CardioCel was associated with reduced incidence of re-operation, increased QALY, and costs savings compared to all other patches. Cost savings were greatest compared to synthetic patches. Estimated cost savings associated with CardioCel were greatest within atrioventricular septal defect repair and lowest for ventricular septal defect repair. Based on our model, CardioCel relative risk for re-operations is 0.938, 0.956and 0.902 relative to xenogeneic, autologous, and synthetic patches, respectively. CONCLUSION: CardioCel was estimated to increase health benefits and save cost when used during surgery for congenital heart defects instead of other patches.

An early analysis of cost-utility of baroreflex activation therapy in advanced chronic heart failure in Germany.

BACKGROUND: This study aimed to evaluate cost-utility of baroreflex activation therapy (BAT) using the Barostim neo™ device (CVRx Inc., Minneapolis, MN, USA) compared with optimized medical management in patients with advanced chronic heart failure (NYHA class III) who were not eligible for treatment with cardiac resynchronization therapy, from a statutory health insurance perspective in Germany over a lifetime horizon. METHODS: A decision analytic model was developed using the combination of a decision tree and the Markov process. The model included transitions between New York Heart Association (NYHA) health states, each of which is associated with a risk of mortality, hospitalization, cost, and quality of life. The effectiveness of BAT was projected through relative risks for mortality (obtained by application of patient-level data to the Meta-analysis Global Group in Chronic Heart Failure risk prediction model) and hospitalization owing to worsening of heart failure (obtained from BAT Randomized Clinical Trial). All patients were in NYHA class III at baseline. RESULTS: BAT led to an incremental cost of €33,185 (95% credible interval [CI] €24,561-38,637) and incremental benefits of 1.78 [95% CI 0.45-2.71] life-years and 1.19 [95% CI 0.30-1.81] quality-adjusted life-years (QALYs). This resulted in an incremental cost-effectiveness ratio of €27,951/QALY (95% CI €21,357-82,970). BAT had a 59% probability of being cost-effective at a willingness-to-pay threshold of €35,000/QALY (but 84% at a threshold of €52,000/QALY). CONCLUSIONS: BAT can be cost-effective in European settings in those not eligible for cardiac resynchronization therapy among patients with advanced heart failure.

Bariatric surgery versus conservative management for morbidly obese patients in Spain: a cost-effectiveness analysis.

BACKGROUND: We assessed the cost-effectiveness of bariatric surgery (BS) versus conservative management (CM) for treating morbid obesity in Spain. METHODS: We developed a probabilistic Markov model to estimate health outcomes, quality-adjusted life years (QALY), life years gained (LYG), and costs over lifetime and 10-year horizons. Combined common BS procedures were compared with CM. Clinical and utility inputs were obtained from the literature and resource use and costs from local sources (€2017). RESULTS: Over the 10-year horizon, BS led to a cost increment of €9,386 and 1.6 additional QALY (€5,966/QALY). Leading to 0.6 LYG and 4.4 QALY gains and €300/patient average cost savings over lifetime, BS could potentially significantly reduce diabetes and cardiovascular disease risk over the considered horizons. Despite short-term cost reductions, surgery delay may lead to significant clinical benefits loss. CONCLUSIONS: Compared to CM, BS is a more effective and less costly alternative for treating morbid obesity in Spain.

Patient Characteristics, Procedural and Safety Outcomes of Bariatric Surgery in England: a Retrospective Cohort Study-2006-2012.

BACKGROUND: The objective of the study is to analyze procedural and safety outcomes associated with bariatric surgery and describe the characteristics of patients undertaking bariatric procedures in England between April 2006 and March 2012. METHODS: This is a retrospective cohort study of all adult patients in England diagnosed with obesity and undergoing bariatric surgery as a primary procedure in NHS-funded sites between April 2006 and March 2012 using data sourced from the Hospital Episode Statistics dataset. Length of stay (LOS), 30-day readmission, and post-surgery complication were analyzed as primary outcomes. Socio-demographic background, provider type, procedure volume, and comorbidities were all analyzed as potential explanatory variables. RESULTS: Gastric bypass (GBP, 12,628) was the most utilized procedure, followed by gastric banding (GB, 6872) and sleeve gastrectomy (SG, 3251). The most prevalent comorbidity was type 2 diabetes (23%). Inpatient mortality was low (≤ 0.15%) for all procedure types. LOS and the risks of both post-operative complication and 30-day readmission were significantly lower for GB, relative to those for GBP and SG. Ethnicity, geographical area, surgery type, and volume were all associated with LOS, risk of readmission, and complication. Provider type and deprivation were further associated with LOS while age correlated with readmission only. An increasing comorbidity burden was associated with an increased risk of both readmission and complication. CONCLUSIONS: Gastric bypass was the most frequently reported procedure in England across the observation period. While utilization across all procedure types increased between 2007 and 2010, overall uptake of bariatric surgery in England represents only a small proportion of the eligible population. Readmission and complication rates were lower for gastric banding relative to those for either gastric bypass or sleeve gastrectomy. The observed inpatient mortality rate was low across all procedure types.

Cost-effectiveness analysis of bariatric surgery for morbid obesity in Belgium.

AIMS: This study presents the cost-effectiveness analysis of bariatric surgery in Belgium from a third-party payer perspective for a lifetime and 10-year horizon. MATERIALS AND METHODS: A decision analytic model incorporating Markov process was developed to compare the cost-effectiveness of gastric bypass, sleeve gastrectomy, and adjustable gastric banding against conventional medical management (CMM). In the model, patients could undergo surgery, or experience post-surgery complications, type 2 diabetes, cardiovascular diseases, or die. Transition probabilities, costs, and utilities were derived from the literature. The impact of different surgical methods on body mass index (BMI) level in the base-case analysis was informed by the Scandinavian Obesity Surgery Registry and the Swedish Obese Subject (SOS) study. Healthcare resource use and costs were obtained from Belgian sources. A base-case analysis was performed for the population, the characteristics of which were obtained from surgery candidates in Belgium. RESULTS: In the base-case analysis over a 10-year time horizon, the increment in quality-adjusted life-years (QALYs) gained from bariatric surgery vs CMM was 1.4 per patient, whereas the incremental cost was €3,788, leading to an incremental cost-effectiveness ratio (ICER) of €2,809 per QALY. Over a lifetime, bariatric surgery produced savings of €9,332, an additional 1.1 life years and 5.0 QALYs. Bariatric surgery was cost-effective at 10 years post-surgery and dominant over conventional management over a lifetime horizon. LIMITATIONS: The model did not include the whole scope of obesity-related complications, and also did not account for variation in surgery outcomes for different populations of diabetic patients. Also, the data about management of patients after surgery was based on assumptions and the opinion of a clinical expert. CONCLUSIONS: It was demonstrated that a current mix of bariatric surgery methods was cost-effective at 10 years post-surgery and cost-saving over the lifetime of the Belgian patient cohort considered in this analysis.

Cost analysis of bariatric surgery in Denmark made with a decision-analytic model.

INTRODUCTION: Bariatric surgery offers effective obesity treatment. The aim of this study was to evaluate the cost-effectiveness of bariatric surgery in Denmark from a third-party payer perspective in the mid- (ten years) and long-term (lifetime). METHODS: A state-transition Markov model was developed in which patients may experience surgery, post-surgery complications, diabetes mellitus type 2, cardiovascular diseases or die. Transition probabilities, costs and utilities were informed by the literature. Three types of surgery were included: gastric bypass, sleeve gastrectomy and adjustable gastric banding. The impact of different surgical methods on BMI level was informed by the Danish Obesity Surgery Registry (Dansk Fedmekirurgiregister). RESULTS: In the ten-year base-case analysis, bariatric surgery led to a cost increment of 19,332 DKK and generated an additional 1.1 quality-adjusted life years (QALYs). In the course of a lifetime, surgery leads to savings of 36,403 DKK, an additional 0.7 life years and 2.9 QALYs. Bariatric surgery was cost-effective at ten years with an incremental cost-effectiveness ratio of 17,818 DKK per QALY and was dominant over conservative management in the course of a lifetime. Up to three years of delay in the provision of surgery resulted in a reduction of life years, a lower QALY gain and a minor decrease in healthcare costs. CONCLUSIONS: In Denmark, bariatric surgery is cost-effective at ten years and may produce a significant reduction in healthcare costs over the course of a lifetime in persons with severe obesity. FUNDING: Synergus AB received support for economic model development from Covidien AG (now part of Medtronic). TRIAL REGISTRATION: not relevant.

Cost-utility analysis of bariatric surgery compared with conventional medical management in Germany: a decision analytic modeling.

BACKGROUND: The objective was to evaluate cost-utility of bariatric surgery in Germany for a lifetime and 10-year horizon from a health care payer perspective. METHODS: State-transition Markov model provided absolute and incremental clinical and monetary results. In the model, obese patients could undergo surgery, develop post-surgery complications, experience diabetes type II, cardiovascular diseases or die. German Quality Assurance in Bariatric Surgery Registry and literature sources provided data on clinical effectiveness and safety. The model considered three types of surgeries: gastric bypass, sleeve gastrectomy, and adjustable gastric banding. The model was extensively validated, and deterministic and probabilistic sensitivity analyses were performed to evaluate uncertainty. Cost data were obtained from German sources and presented in 2012 euros (€). RESULTS: Over 10 years, bariatric surgery led to the incremental cost of €2909, generated additional 0.03 years of life and 1.2 quality-adjusted life years (QALYs). Bariatric surgery was cost-effective at 10 years with an incremental cost-effectiveness ratio of €2457 per QALY. Over a lifetime, surgery led to savings of €8522 and generated an increment of 0.7 years of life or 3.2 QALYs. The analysis also depicted an association between surgery and a reduction of obesity-related adverse events (diabetes, cardiovascular disorders). Delaying surgery for up to 3 years, resulted in a reduction of life years and QALYs gained, in addition to a moderate reduction in associated healthcare costs. CONCLUSIONS: Bariatric surgery is cost-effective at 10 years post-surgery and may result in a substantial reduction in the financial burden on the healthcare system over the lifetime of the treated individuals. It is also observed that delays in the provision of surgery may lead to a significant loss of clinical benefits.

Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study.

BACKGROUND AND AIMS: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with a poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump® [AP]) compared with LVP standard of care [SoC]. METHODS: A randomized controlled trial, in seven centers, with six month patient observation was conducted. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival. Nutrition, hemodynamics, and renal injury biomarkers were assessed in a sub-study at three months. RESULTS: Sixty patients were randomized and 58 were analyzed (27 AP, 31 SoC, mean age 61.9years, mean MELD 11.7). Eighteen patients were included in the sub-study. Compared with SoC, median time to first LVP was not reached after six months in the AP group, meaning a significant reduction in LVP requirement for the AP patients (AP, median not reached; SoC, 15.0days (HR 0.13; 95%CI 13.0-22.0; p<0.001), and AP patients also showed significantly improved Chronic Liver Disease Questionnaire (CLDQ) scores compared with SoC patients (p<0.05 between treatment arms). Improvements in nutritional parameters were observed for hand-grip strength (p=0.044) and body mass index (p<0.001) in the sub-study. Compared with SoC, more AP patients reported adverse events (AEs; 96.3% vs. 77.4%, p=0.057) and serious AEs (85.2 vs. 45.2%, p=0.002). AEs consisted predominantly of acute kidney injury in the immediate post-operative period, and re-intervention for pump related issues, and were treatable in most cases. Survival was similar in AP and SoC. CONCLUSIONS: The AP system is effective for reducing the need for paracentesis and improving quality of life in cirrhotic patients with RA. Although the frequency of SAEs (and by inference hospitalizations) was significantly higher in the AP group, they were generally limited and did not impact survival. Lay summary: The alfapump® moves abdominal fluid into the bladder from where it is then removed by urination. Compared with standard treatment, the alfapump reduces the need for large volume paracentesis (manual fluid removal by needle) in patients with medically untreatable ascites. This can improve life quality for these patients. www.clinicaltrials.gov#NCT01528410.

Cost-Utility Analysis of Bariatric Surgery in Italy: Results of Decision-Analytic Modelling.

OBJECTIVE: To evaluate the cost-effectiveness of bariatric surgery in Italy from a third-party payer perspective over a medium-term (10 years) and a long-term (lifetime) horizon. METHODS: A state-transition Markov model was developed, in which patients may experience surgery, post-surgery complications, diabetes mellitus type 2, cardiovascular diseases or die. Transition probabilities, costs, and utilities were obtained from the Italian and international literature. Three types of surgeries were considered: gastric bypass, sleeve gastrectomy, and adjustable gastric banding. A base-case analysis was performed for the population, the characteristics of which were obtained from surgery candidates in Italy. RESULTS: In the base-case analysis, over 10 years, bariatric surgery led to cost increment of EUR 2,661 and generated additional 1.1 quality-adjusted life years (QALYs). Over a lifetime, surgery led to savings of EUR 8,649, additional 0.5 life years and 3.2 QALYs. Bariatric surgery was cost-effective at 10 years with an incremental cost-effectiveness ratio of EUR 2,412/QALY and dominant over conservative management over a lifetime. CONCLUSION: In a comprehensive decision analytic model, a current mix of surgical methods for bariatric surgery was cost-effective at 10 years and cost-saving over the lifetime of the Italian patient cohort considered in this analysis.

Berezinskii-Kosterlitz-Thouless phase transitions in two-dimensional non-Abelian spin models.

It is argued that two-dimensional U(N) spin models for any N undergo a Berezinskii-Kosterlitz-Thouless (BKT)-like phase transition, similarly to the famous XY model. This conclusion follows from the Berezinskii-like calculation of the two-point correlation function in U(N) models, approximate renormalization group analysis, and numerical investigations of the U(2) model. It is shown, via Monte Carlo simulations, that the universality class of the U(2) model coincides with that of the XY model. Moreover, preliminary numerical results point out that two-dimensional SU(N) spin models with the fundamental and adjoint terms and N>4 exhibit two phase transitions of BKT type, similarly to Z(N) vector models.

Systematic literature review of use of blood glucose monitoring in phase III clinical studies of insulin analogs.

BACKGROUND: Safe and effective insulin therapy for diabetes mellitus requires initial dose titration and regular adjustments based on blood glucose (BG) monitoring. Our objective was to explore the use of BG measurement in phase-III clinical studies of insulin analogs. These studies provide safety and efficacy information for regulatory authorities and are the basis for insulin analog regulatory approval. METHODS: A systematic review of phase-III studies of rapid-acting insulin analogs (insulin lispro, insulin aspart and insulin glulisine) and pre-mixed insulin analogs (biphasic insulin aspart and insulin lispro mix) was conducted. Studies were identified using manufacturers' databases. Search for reports was performed in Medline and registry of clinical trials (clinicaltrials.gov). The European Medicines Agency was contacted to provide Clinical Study Reports. RESULTS: Forty-five studies were included. Regular BG measurements were reported in 100 % of the studies and were performed by either self-monitoring of blood glucose (SMBG) alone in 84 %, laboratory alone in 7 %, and both SMBG and laboratory in 9 % of studies. In total, 93 % of the studies reported SMBG. Most studies (91 %) reported insulin therapy adjustments based on BG measurements. CONCLUSIONS: The findings suggest that BG monitoring and specifically SMBG are co-dependent technologies with insulin analogs. BG measurement is used in most phase-III registration studies for establishing safe and efficacious insulin administration and is recommended in the insulin labels. The indispensable role of SMBG in treatment of insulin-dependent patients should receive attention from health care payers to assess and reimburse SMBG along with insulin to avoid adverse events from inappropriate insulin administration and associated costs.

Cost-utility analysis of percutaneous mitral valve repair in inoperable patients with functional mitral regurgitation in German settings.

BACKGROUND: To determine the cost-effectiveness of the percutaneous mitral valve repair (PMVR) using Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) in patients with congestive heart failure accompanied by moderate to severe functional mitral regurgitation (FMR) compared to the prolongation of optimal medical treatment (OMT). METHODS: Cost-utility analysis using a combination of a decision tree and Markov process was performed. The clinical effectiveness was determined based on the results of the Transcatheter Implantation of Carillon Mitral Annuloplasty Device (TITAN) trial. The mean age of the target population was 62 years, 77% of the patients were males, 64% of the patients had severe FMR and all patients had New York Heart Association functional class III. The epidemiological, cost and utility data were derived from the literature. The analysis was performed from the German statutory health insurance perspective over 10-year time horizon. RESULTS: Over 10 years, the total cost was €36,785 in the PMVR arm and €18,944 in the OMT arm. However, PMVR provided additional benefits to patients with an 1.15 incremental quality-adjusted life years (QALY) and an 1.41 incremental life years. The percutaneous procedure was cost-effective in comparison to OMT with an incremental cost-effectiveness ratio of €15,533/QALY. Results were robust in the deterministic sensitivity analysis. In the probabilistic sensitivity analysis with a willingness-to-pay threshold of €35,000/QALY, PMVR had a 84 % probability of being cost-effective. CONCLUSIONS: Percutaneous mitral valve repair may be cost-effective in inoperable patients with FMR due to heart failure.

Health economic evaluations of medical devices in the People's Republic of China: A systematic literature review.

BACKGROUND: The objective of this study is to identify and review the methodological quality of health economic evaluations of medical devices performed in the People's Republic of China. To our knowledge, no such investigations have been performed to date. METHODS: A systematic literature review involving searches of Medline, Medline In-Process, the National Health Service Economic Evaluation Database, the Cost-Effectiveness Analysis Registry of the Tufts Medical Center, and the Wanfang Database was performed. The search spanned the period from 1990 to 2013. Studies on health economic evaluations of medical devices, in-vitro diagnostics, procedures, and the use of medical devices in Chinese health care settings were included. Full-text articles and conference abstracts in English and Chinese were included. RESULTS: Fifty-seven publications were included, 26 (46%) of which were in English and 31 (54%) of which were in Chinese. The included publications covered a wide range of clinical areas, such as surgery (n=23, 40%), screening (n=9, 16%), imaging use (n=6, 11%), kidney intervention (n=4, 7%), and nine other technological areas. Most of the studies (n=31, 54%) were cost analyses. Among the others, 13 (50%) studies used modeling, and another 13 (50%) were within-trial evaluations. Among studies that used modeling, eleven (85%) conducted sensitivity analyses, six of which had one-way sensitivity analysis, whereas one conducted both one-way and two-way sensitivity analyses; four of these eleven modeling-based analyses included probabilistic sensitivity analyses. The incremental cost-effectiveness ratio was reported in ten (18%) studies, eight of which were screening studies. The remaining two modeling studies were in areas of imaging and oncology. CONCLUSION: This study indicates that there are major limitations and deficiencies in the health economic evaluations on medical devices performed in the People's Republic of China. Further efforts are required from different stakeholders - academic, governmental, and privatized - to improve health economic research capacity and to put it to use when informative decisions are made in the health care setting.

Bariatric Surgery can Lead to Net Cost Savings to Health Care Systems: Results from a Comprehensive European Decision Analytic Model.

BACKGROUND: The objective of the present study was to evaluate the cost-utility of bariatric surgery in a lifetime horizon from a Swedish health care payer perspective. METHODS: A decision analytic model using the Markov process was developed covering cardiovascular diseases, type 2 diabetes, and surgical complications. Clinical effectiveness and safety were based on the literature and data from the Scandinavian Obesity Surgery Registry. Gastric bypass, sleeve gastrectomy, and gastric banding were included in the analysis. Cost data were obtained from Swedish sources. RESULTS: Bariatric surgery was cost saving in comparison with conservative management. It also led to a substantial reduction in lifetime risk of events: from a 16 % reduction in the risk of transient ischaemic attacks to a 62 % reduction in the incidence of type 2 diabetes. Over a lifetime, surgery led to savings of euro 8408 and generated an additional 0.8 years of life and 4.1 quality-adjusted life years (QALYs) per patient, which translates into gains of 32,390 quality-adjusted person-years and savings of euro 66 million for the cohort, operated in 2012. Analysis of the consequences of a 3-year delay in surgery provision showed that the overall lifetime cost of treatment may be increased in patients with diabetes or a body mass index >40 kg/m(2). Delays in surgery may also lead to a loss of clinical benefits: up to 0.6 life years and 1.2 QALYs per patient over a lifetime. CONCLUSION: Bariatric surgery, over a lifetime horizon, may lead to significant cost savings to health care systems in addition to the known clinical benefits.

Clinical Indications, Utilization, and Funding of Bariatric Surgery in Europe.

PURPOSE: The objective of this study was to evaluate the current utilization, the level of endorsement by professional societies, and health technology assessment bodies, as well as the reimbursement levels for bariatric surgery in European countries. MATERIALS AND METHODS: We performed an analysis of the indications for bariatric surgery based on national clinical and commissioning guidelines, current utilization of surgery, characteristics of patients who underwent surgery, and reimbursement tariffs in Belgium, Denmark, England, France, Germany, Italy, and Sweden. Data were obtained from national patient registries, administrative databases, and published literature for the year 2012. RESULTS: Despite clear consensus outlined in clinical guidelines, significant differences were found in the eligibility criteria for surgery. Patients with no significant comorbidities were deemed eligible if they had a body mass index (BMI) of 40 or 50 kg/m(2) in Denmark. Irrespective of the country, patients with comorbidities were eligible if they had a BMI of 35 kg/m(2). The highest utilization of bariatric surgery (number of surgeries per 1 M population) was observed in Belgium (928), Sweden (761), and France (571) while Italy (128), England (117), and Germany (72) had the lowest utilization. There was a strong negative correlation between utilization and average BMI level of the patient population (r = -.909, p = 0.005). The annual per capita spending on surgery differed significantly between countries, ranging from 0.54 in Germany to 4.33 in Belgium. CONCLUSIONS: There are significant variations in the clinical indications, utilization, and funding of bariatric surgery in European countries.