Reevaluating the Evidence for Intensive Postoperative Extracolonic Surveillance for Nonmetastatic Colorectal Cancer.

OBJECTIVES: The FACS, GILDA, and COLOFOL trials have cast doubt on the value of intensive extracolonic surveillance for resected nonmetastatic colorectal cancer and by extension metastasectomy. We reexamined this pessimistic interpretation. We evaluate an alternative explanation: insufficient power to detect a realistically sized survival benefit that may be clinically meaningful. METHODS: A microsimulation model of postdiagnosis colorectal cancer was constructed assuming an empirically plausible efficacy for metastasectomy and thus surveillance. The model was used to predict the large-sample mortality reduction expected for each trial and the implied statistical power. A potential recurrence imbalance in the FACS trial was investigated. Goodness of fit between model predictions and trial results were evaluated. Downstream life expectancy was estimated and power calculations performed for future trials evaluating surveillance and metastasectomy. RESULTS: For all 3 trials, the model predicted a mortality reduction of ≤5% and power of <10%. The FACS recurrence imbalance likely led to a large relative bias (>2.5) in the hazard ratio for overall survival favoring control. After adjustment, both COLOFOL and FACS results were consistent with model predictions (P>.5). A 2.6 (95% credible interval 0.5-5.1) and 3.6 (95% credible interval 0.8-7.0) month increase in life expectancy is predicted comparing intensive extracolonic surveillance-routine computed tomography scans and carcinoembryonic antigen assays-with 1 computed tomography scan at 12 months or no surveillance, respectively. An adequately sized surveillance trial is not feasible. A metastasectomy trial should randomize at least 200 to 300 patients. CONCLUSIONS: Recent trial results do not warrant de novo skepticism of metastasectomy nor targeted extracolonic surveillance. Given the potential for clinically meaningful life-expectancy gain and significant uncertainty, a trial of metastasectomy is needed.

A multicenter study of total pancreatectomy with islet autotransplantation (TPIAT): POST (Prospective Observational Study of TPIAT).

BACKGROUND/OBJECTIVES: Total pancreatectomy with islet autotransplantation (TPIAT) is considered for managing chronic pancreatitis in selected patients when medical and endoscopic interventions have not provided adequate relief from debilitating pain. Although more centers are performing TPIAT, we lack large, multi-center studies to guide decisions about selecting candidates for and timing of TPIAT. METHODS: Multiple centers across the United States (9 to date) performing TPIAT are prospectively enrolling patients undergoing TPIAT for chronic pancreatitis into the Prospective Observational Study of TPIAT (POST), a NIDDK funded study with a goal of accruing 450 TPIAT recipients. Baseline data include participant phenotype, pancreatitis history, and medical/psychological comorbidities from medical records, participant interview, and participant self-report (Medical Outcomes Survey Short Form-12, EQ-5D, andPROMIS inventories for pain interference, depression, and anxiety). Outcome measures are collected to at least 1 year after TPIAT, including the same participant questionnaires, visual analog pain scale, pain interference scores, opioid requirements, insulin requirements, islet graft function, and hemoglobin A1c. Health resource utilization data are collected for a cost-effectiveness analysis. Biorepository specimens including urine, serum/plasma, genetic material (saliva and blood), and pancreas tissue are collected for future study. CONCLUSIONS: This ongoing multicenter research study will enroll and follow TPIAT recipients, aiming to evaluate patient selection and timing for TPIAT to optimize pain relief, quality of life, and diabetes outcomes, and to measure the procedure's cost-effectiveness. A biorepository is also established for future ancillary studies.

Impact of a workplace physical activity tracking program on biometric health outcomes.

Wellness programs are a popular strategy utilized by large U.S. employers. As mobile health applications and wearable tracking devices increase in prevalence, many employers now offer physical activity tracking applications. This longitudinal study evaluates the impact of engagement with a web-based, physical activity tracking program on changes in individuals' biometric outcomes in an employer population. The study population includes active employees and adult dependents continuously enrolled in an eligible health plan and who have completed at least two biometric screenings (n=36,882 person-years with 11,436 unique persons) between 2011 and 2014. Using difference-in-differences (DID) regression, we estimate the effect of participation in the physical activity tracking application on BMI, total cholesterol, and blood pressure. Participation was significantly associated with a reduction of 0.275 in BMI in the post-period, relative to the comparison group, representing a 1% change from baseline BMI. The program did not have a statistically significant impact on cholesterol or blood pressure. Sensitivity checks revealed slightly larger BMI reductions among participants with higher intensity of tracking activity and in the period following the employer's shift to an outcomes-based incentive design. Results are broadly consistent with the existing literature on changes in biometric outcomes from workplace initiatives promoting increased physical activity. Employers should have modest expectations about the potential health benefits of such programs, given current designs and implementation in real-world settings.

Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial.

BACKGROUND: Evidenced-based tobacco cessation treatments are underused, especially by socioeconomically disadvantaged smokers. This contributes to widening socioeconomic disparities in tobacco-related morbidity and mortality. METHODS: The Offering Proactive Treatment Intervention trial tested the effects of a proactive outreach tobacco treatment intervention on population-level smoking abstinence and tobacco treatment use among a population-based sample of socioeconomically disadvantaged smokers. Current smokers (n=2406), regardless of interest in quitting, who were enrolled in the Minnesota Health Care Programs, the state's publicly funded healthcare programmes for low-income populations, were randomly assigned to proactive outreach or usual care. The intervention comprised proactive outreach (tailored mailings and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive, telephone counselling). Usual care comprised access to a primary care physician, insurance coverage of Food and Drug Administration-approved smoking cessation medications, and the state's telephone quitline. The primary outcome was self-reported 6-month prolonged smoking abstinence at 1 year and was assessed by follow-up survey. FINDINGS: The proactive intervention group had a higher prolonged abstinence rate at 1 year than usual care (16.5% vs 12.1%, OR 1.47, 95% CI 1.12 to 1.93). The effect of the proactive intervention on prolonged abstinence persisted in selection models accounting for non-response. In analysis of secondary outcomes, use of evidence-based tobacco cessation treatments were significantly greater among proactive outreach participants compared with usual care, particularly combination counselling and medications (17.4% vs 3.6%, OR 5.69, 95% CI 3.85 to 8.40). INTERPRETATION: Population-based proactive tobacco treatment increases engagement in evidence-based treatment and is effective in long-term smoking cessation among socioeconomically disadvantaged smokers. Findings suggest that dissemination of population-based proactive treatment approaches is an effective strategy to reduce the prevalence of smoking and socioeconomic disparities in tobacco use. TRIAL REGISTRATION NUMBER: NCT01123967.

Affordability of the Health Expenditures of Insured Americans Before the Affordable Care Act.

Central to the Affordable Care Act is the notion of affordability and the role of health insurance in making otherwise unaffordable health care affordable. We used data from the 1996 to 2008 versions of the Medical Expenditure Panel Survey to estimate the portion of overall health care expenditures by insured respondents that would otherwise have been beyond their disposable incomes and assets. We found that about one third of insured expenditures would have been unaffordable, with a much higher percentage among publicly insured individuals. This result suggests that one of the main functions of insurance is to cover expenses that insured individuals would not otherwise be able to afford.

Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial.

BACKGROUND: There is a high prevalence of smoking and high burden of tobacco-related diseases among low-income populations. Effective, evidenced-based smoking cessation treatments are available, but low-income smokers are less likely than higher-income smokers to use these treatments, especially the most comprehensive forms that include a combination of pharmacotherapy and intensive behavioral counseling. METHODS/DESIGN: The primary objectives of this randomized controlled trial are to compare the effects of a proactive tobacco treatment intervention compared to usual care on population-level smoking abstinence rates and tobacco treatment utilization rates among a diverse population of low-income smokers, and to determine the cost-effectiveness of proactive tobacco treatment intervention. The proactive care intervention systematically offers low-income smokers free and easy access to evidence-based treatments and has two primary components: (1) proactive outreach to current smokers in the form of mailed invitation materials and telephone calls containing targeted health messages, and (2) facilitated access to free, comprehensive, evidence-based tobacco cessation treatments in the form of NRT and intensive, telephone-based behavioral counseling. The study aims to include a population-based sample (N = 2500) of adult smokers enrolled in the Minnesota Health Care Programs (MHCP), a state-funded health insurance plan for low-income persons. Baseline data is obtained from MHCP administrative databases and a participant survey that is conducted prior to randomization. Outcome data is collected from a follow-up survey conducted 12 months after randomization and MHCP administrative data. The primary outcome is six-month prolonged smoking abstinence at one year and is assessed at the population level. All randomized individuals are asked to complete the follow-up survey, regardless of whether they participated in tobacco treatment. Data analysis of the primary aims will follow intent-to-treat methodology. DISCUSSION: There is a critical need to increase access to effective tobacco dependence treatments. This randomized trial evaluates the effects of proactive outreach coupled with free NRT and telephone counseling on the population impact of tobacco dependence treatment. If proven to be effective and cost-effective, national dissemination of proactive treatment approaches would reduce tobacco-related morbidity, mortality, and health care costs for low income Americans. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov: NCT01123967.

A cost effectiveness analysis of stepped care treatment for bulimia nervosa.

BACKGROUND: The cost effectiveness of various treatment strategies for bulimia nervosa (BN) is unknown. AIMS: To examine the cost effectiveness of stepped care treatment for BN. METHOD: Randomized trial conducted at four clinical centers with intensive measurement of direct medical costs and repeated measurement of subject quality of life and family/significant other time involvement. Two hundred ninety-three women who met DSM-IV criteria for BN received stepped care treatment or cognitive behavioral therapy. Cost effectiveness ratios were compared. RESULTS: The cost per abstinent subject was $12,146 for stepped care, and $20,317 for cognitive behavioral therapy. Quality of life ratings improved significantly with treatment, and family/significant other time burden diminished substantially. DISCUSSION: In this trial, stepped care for BN appeared cost effective in comparison to cognitive behavioral therapy. Treatment was associated with improved quality of life and diminished time costs of illness.

The effect of consumer incentives on Medicaid beneficiaries' compliance with well-child visit guidelines.

The Affordable Care Act of 2010 recommends that consumer incentives be employed to increase the use of preventive care by Medicaid beneficiaries, but few evaluative studies exist. This study evaluates a Target gift card incentive employed by a Minnesota health plan serving Medicaid beneficiaries over the period 2002-2003. Lacking a contemporaneous control group, the proximity between the child's residence and the nearest Target store was used as the intervention variable. Using alternative specifications for the intervention variable, results of the difference-in-differences equations suggest that the incentive program significantly increased the likelihood that a Medicaid beneficiary would have a well-child visit.

Work and non-pathological gambling.

Most economists believe that people would value an additional $1,000 in income more if they were poor than if rich, but if so, people should not gamble according to standard expected utility theory. Thus, economists have been challenged to explain the pervasiveness of gambling in human behavior. A recently proposed solution to this theoretical challenge (Nyman 2004; Nyman et al. in Journal of Socio-Economics 37:2492-2504, 2008) suggests that, because having to work for one's income is a fact of life in market economies, many individuals view the winnings from gambling not only as additional income, but as additional income for which one does not need to work. As a result, individuals, and especially those who are disadvantaged in the labor market, attach a utility premium to gambling winnings and gamble because of that. This utility premium would explain the pervasiveness of gambling in society, especially among the economically disadvantaged. This paper reviews the economic approaches to explaining non-pathological gambling, presents an overview of the new theory, and uses data from the National Epidemiological Survey of Alcohol and Related Conditions from 2001 to test it. The results indicate that the respondent's work characteristics explain the decision to gamble in a way that is consistent with theory.

Cost considerations regarding the prospective surveillance model for breast cancer survivors.

For this article, the authors examined the cost implications of the prospective surveillance model (PSM) for breast cancer (BC) survivors, a comprehensive framework designed to preemptively reduce the incidence and virulence of common impairments. The model clearly has the potential of providing significant benefits. However, its accompanying costs and resource requirements remain unclear and may be substantial. Thus, it is critical to examine which BC survivors may benefit from the PSM, how much they will benefit, and the costs of this benefit before its implementation. Because the PSM is not rigidly prescriptive, its examination must allow for different scenarios with emphasis on 4 critical determinants of cost--whether all or only high-risk BC survivors participate, assessment frequencies and locations, the credentials of the assessors, and requirements for supportive equipment. Another issue is the distribution of its cost: hypothetical implementation strategies vary widely in their distribution of fiscal burden across key stakeholders--survivors, providers, and payers--whose financial responsibilities will be an important factor in whether and how rapidly they adopt the PSM. Accurate valuation of the PSM will require capture of direct and indirect cost savings and benefits. Currently, a lack of data regarding these parameters, as well as outcomes that can be reliably attributed to the PSM, impedes cost-effectiveness analyses. Because the PSM may enhance many health state characteristics, assessments that integrate overall composite measures with evaluations of common, discrete impairments may be required to comprehensively assess its benefits.

The effectiveness of a health promotion program after 3 years: evidence from the University of Minnesota.

BACKGROUND: Health promotion programs for the workplace are often sold to employers with the promise that they will pay for themselves with lowered health care expenditures and reduced absenteeism. In a recent review of the literature, it was noted that analysts often caution not to expect a positive return on investment until the third year of operation. OBJECTIVE: This study investigates whether a positive return on investment was generated in the third year for the health promotion program used by the University of Minnesota. It further investigates what it is about the third year that would explain such a phenomenon. MEASURES: The study uses health care expenditure data and absenteeism data from 2004 to 2008 to investigate the effect of the University's lifestyle and disease management programs. It also investigates the effectiveness of participation in Minnesota's 10,000 Steps walking program and Miavita self-help programs. RESEARCH DESIGN: A differences-in-differences equations approach is used to address potential selection bias. Possible regression to the mean is dealt with by using only those who were eligible to participate as control observations. Propensity score weighting was used to balance the sample on observable characteristics and reduce bias due to omitted variables. RESULTS: The study finds that a 1.76 return on investment occurs in the third year of operation that is generated solely by the effect of disease management program participation in reducing health care expenditures. However, neither of the explanations for a third-year effect we tested seemed to be able to explain this phenomenon.

A health economic analysis of clinical islet transplantation.

Islet cell transplantation is in clinical development for type 1 diabetes. There are no data on the cost in relationship to its benefits. We performed a cost-effectiveness analysis and made a comparison with standard insulin therapy, using Markov modeling and Monte Carlo simulations. The patient population was adults aged 20 yr suffering from hypoglycemia unawareness. Data were estimates from literature and clinical trials: costs were based on the situation in the United States. For insulin therapy, cumulative cost per patient during a 20-yr follow-up was $663,000, and cumulative effectiveness was 9.3 quality-adjusted life years (QALY), the average cost-effectiveness ratio being $71,000 per QALY. Islet transplantation had a cumulative cost of $519,000, a cumulative effectiveness of 10.9 QALY, and an average cost-effectiveness ratio of $47,800. During the first 10 yr, costs for transplantation were higher, but cumulative effectiveness was higher from the start onwards. In sensitivity analyses, the need for one instead of two transplants during the first year did not affect the conclusions, and islet transplantation remained cost-saving up to an initial cost of the procedure of $240,000. This exploratory evaluation shows that islet cell transplantation is more effective than standard insulin treatment, and becomes cost-saving at about 9-10 yr after transplantation.

Measurement of QALYS and the welfare implications of survivor consumption and leisure forgone.

In previous work (Health Econ. 2004; 13: 417-427; Health Econ. 2006; 15: 319-322) has suggested that survivor consumption costs should be included in cost-utility analyses only if the corresponding utility gains are also included. Here, it is further argued that the welfare implications of survivor consumption are already known because unlike new medical treatments or interventions whose complex and uncertain outcomes and third-party purchasing make the welfare implications unclear, survivor consumption must have passed a private market welfare test. That is, the gains must have exceeded the costs in order for the survivor consumption to be purchased; therefore, survivor consumption is welfare increasing. The same would apply for survivor leisure forgone. Implications for cost-benefit analysis are clear, but are less so for cost-utility analysis. Moreover, as it is currently practiced, cost-utility analysis does not evaluate welfare because quality-adjusted life years (QALYs) do not meet all the criteria for representing utility. Therefore, rather than using QALYs to analyze welfare, cost-QALY analysis should be differentiated from cost-utility analysis. The former should continue to employ existing QALYs as a measure of health-focused effectiveness, but the latter should develop a new broader measure that meets the criteria for representing utility, and either this new measure or cost-benefit analysis should be used to evaluate welfare.

What factors influence participation in an exercise-focused, employer-based wellness program?

Following the recent introduction of an incentive-based, exercise-focused wellness program at a large public university, this paper investigates the factors that influence employees' behavior with respect to participation and regular exercise. Results suggest that an employee's probability of signing up for the program is related to her exercise behavior prior to the program's inception, the time cost of exercise, taste for fitness center exercise, and attitudes about the benefits and barriers of exercise. Employees who are older, male, and were regular fitness center exercisers prior to the program's inception are more likely to be regular exercisers.

Effects of marsh pond terracing on coastal wintering waterbirds before and after Hurricane Rita.

From February to March 2005-2006, we surveyed wintering waterbirds to test effects of terracing on coastal pond use before and after Hurricane Rita. Marsh terracing is intended to slow coastal marsh loss in the Chenier Plain by slowing marsh erosion and encouraging vegetation expansion. Terraces also increase marsh edge in ponds, possibly benefiting waterbirds. We monitored paired terraced and unterraced ponds in three sites within southwestern Louisiana's Chenier Plain. Waterbirds were 75% more numerous in terraced than unterraced ponds. Waterbird richness was similar among ponds when corrected for number of individuals, suggesting terracing increased bird density but did not provide habitat unique from unterraced ponds. Birds were 93% more numerous following Hurricane Rita, mostly due to an influx of migrating waterfowl. Year round residents were similar in number before and after Hurricane Rita. Resident richness did not differ among years after correcting for number of observed individuals. Wading and dabbling foragers were more abundant in terraced ponds and these two guilds represented 74% of birds observed. We detected no difference among ponds for other guilds, i.e., probing, aerial, and diving foragers. Increasing proportion of mash edge increased bird density disproportionately: On average ponds with 10% edge had 6 birds observed and ponds with 30% edge had 16 birds observed. Terraces increased habitat interspersion and were an effective tool for increasing numbers of wintering waterfowl and wading birds. The extent to which terraces were sustainable following hurricane forces is unknown.

Cost of Medicare for All: Review of the Estimates.

This paper critically evaluates the estimates of the cost of Medicare for All (M4A) in the USA. Six studies that estimate the 1-year total cost of M4A in the USA are reviewed. These studies find that M4A would increase national health spending by as much as 16.9% or decrease it by 20.0%, representing a range of estimates that generates uncertainty and confusion regarding what to expect if M4A were implemented. To develop more comparable estimates, the national health spending in each study's comparison year is used as the baseline. Estimates of the change in national health spending under M4A for each report are broken down into five important components of costs and the percentage change from baseline is calculated. The assumptions regarding these cost components are evaluated for each study, and errors and inconsistencies identified. Using data from the literature and findings that are consistent across the reports where they exist, errors and inconsistencies are corrected, and new estimates of the cost components and the overall change in national health spending are calculated. After eliminating one of the reports as having methods that are too opaque to adjust and being an implausible outlier, and adjusting the findings of the remaining five reports, this paper finds that M4A would generate savings from 2.0 to 5.1% of baseline national health spending, averaging 3.9%. M4A would cost about 4% less than current national health spending, and eliminate the uninsured, expand coverage, and likely improve the health of Americans.

Wealth and the utilization of long-term care services: evidence from the United States.

Long-term care (LTC) provision and financing has become a major challenge for policymakers in the United States and worldwide. To inform associated policies and more efficiently allocate LTC resources, it is important to understand how demand for different types of LTC services responds to increased wealth. We use data from the United States Health and Retirement Study to examine the use of LTC services following plausibly exogenous positive shocks to wealth. We further account for time-invariant household-level characteristics, including the expectation of a wealth shock at an unknown future time, by employing household fixed effects. We find that large positive wealth shocks lead to a greater probability of purchase of paid home care but not of nursing home care. Our results imply that expanding home and community-based services and insurance coverage of home care for people without sufficient wealth is likely to be efficient and welfare improving and should be considered by policymakers.Please confirm if the author names are presented accurately and in the correct sequence (given name, middle name/initial, family name). Author 4 Given name: [R. Tamara] Last name: [Konetzka]. Also, kindly confirm the details in the metadata are correct.confirmedPlease confirm the city are correct and amend if necessary in Affiliations 1, 2, 3, 4.confirmed.

Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial.

BACKGROUND: Suboptimal treatment of hypertension remains a widespread problem, particularly among minorities and socioeconomically disadvantaged groups. We present a health system-based intervention with diverse patient populations using readily available smartphone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control. OBJECTIVE: The mGlide randomized controlled trial is a National Institutes of Health-funded study, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between interprofessional health care teams and patients results in better hypertension control rates than a state-of-clinical care comparison. METHODS: We are recruiting 450 participants including stroke survivors and primary care patients with elevated cardiovascular disease risk from diverse health systems. These systems include an acute stroke service (n=100), an academic medical center (n=150), and community medical centers including Federally Qualified Health Centers serving low-income and minority (Latino, Hmong, African American, Somali) patients (n=200). The primary aim tests the clinical effectiveness of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained hypertension control rates at 12 months; describe provider experiences of system usability and satisfaction; examine patient experiences, including medication adherence and medication use self-efficacy, self-rated health and quality of life, and adverse event rates; and complete a cost-effectiveness analysis. RESULTS: To date, we have randomized 107 participants (54 intervention, 53 control). CONCLUSIONS: This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to-practice gap in hypertension treatment in health systems serving diverse patient populations. TRIAL REGISTRATION: Clinicaltrials.gov NCT03612271; https://clinicaltrials.gov/ct2/show/NCT03612271. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25424.

A health-economic analysis of porcine islet xenotransplantation.

BACKGROUND: Islet cell transplantation is a promising treatment for type 1 diabetes. To overcome the shortage of deceased human pancreas donors, porcine islet cell xenotransplantation is being developed as an alternative to allotransplantation. The objective of this study was to perform a cost-effectiveness analysis of porcine islet transplantation in comparison with standard insulin therapy. The patient population for this study was young adults, ages 20 to 40, for whom standard medical care is inadequate in controlling blood glucose levels (hypoglycemia unawareness). Since trial data were lacking, estimates used extrapolations from data found in the literature and ongoing trials in clinical allotransplantation. Cost estimates were based on the data available in the USA. METHODS: Markov modeling and Monte Carlo simulations using software specifically developed for health-economic evaluations were used. Outcomes data for ongoing clinical islet allotransplantation from the University of Minnesota were used, along with probabilities of complications from the Diabetes Control and Complications Trial. Quality-adjusted life years (QALYs) were the effectiveness measure. The upper limit of being cost-effective is $100,000 per QALY. Cost data from the literature were used and adjusted to 2007 US dollars using the medical care portion of the Consumer Price Index. RESULTS: In both Markov modeling and Monte Carlo simulations, porcine islet xenotransplantation was both more effective and less costly over the course of the 20-yr model. For standard insulin therapy, cumulative cost per patient was $661,000, while cumulative effectiveness was 9.4 QALYs, for a cost of $71,100 per QALY. Transplantation had a cumulative cost of $659 000 per patient, a cumulative effectiveness of 10.9 QALYs, and a cost per QALY of $60,700. Islet transplantation became cost-effective at 4 yr after transplantation, and was more cost-effective than standard insulin treatment at 14 yr. These findings are related to relative high costs in the transplantation arm of the evaluation during the first years while those in the insulin arm became higher later in follow-up. Throughout the follow-up period, effectiveness of transplantation was higher than that of insulin treatment. In sensitivity analysis, duplication or triplication of one-time initial costs such as costs of donor animal, islet manufacturing and transplantation had no effect on long-term outcome in terms of cost-saving or cost-effectiveness, but the outcome of transplantation in terms of diabetes complications in cases with partial graft function could affect cost-saving and cost-effectiveness conclusions. CONCLUSION: Despite limitations in the model and lack of trial data, and under the assumption that islet transplantation outcomes for young adult type 1 diabetes patients are not dependent on the source of islet cells, this health-economic evaluation suggests that porcine islet cell xenotransplantation may prove to be a cost-effective and possibly cost-saving procedure for type 1 diabetes compared to standard management.

Cost-effectiveness analysis of protected carotid artery stent placement versus endarterectomy in high-risk patients.

PURPOSE: To determine the cost-effectiveness of carotid angioplasty with stent placement (CAS) under emboli protection versus carotid endarterectomy (CEA) in patients with severe carotid stenosis considered to be at high surgical risk for CEA. METHODS: The probabilities of various outcomes were adopted from the SAPPHIRE trial results. The quality-adjusted life year (QALYs) associated with each treatment modality were estimated by using the frequencies of various quality-adjusted outcomes (QALY weights of ipsilateral stroke, myocardial infarction, and death). Total cost associated with each intervention was computed using the frequency of stroke, myocardial infarction, and death in each group. Costs are expressed in 2006 US$. Incremental cost-effectiveness ratios (ICERs) were estimated for a 1-year postprocedure period. RESULTS: The mean (range) estimated net costs at 1 year for patients treated with CAS and CEA were $12,782 ($12,205-$13,563) and $8,916 ($8,267-$9,766), respectively. Overall QALYs for the CAS and CEA groups were 0.753 and 0.701 [within a range of 0.0 (meaning death) to 0.815 (meaning no adverse events)]. The mean cost per QALY gained for CAS was $16,223 ($15,315-$17,474) and the mean cost per QALY gained for CEA was $12,745 ($11,372-$14,605). The estimated median ICER for CAS versus CEA treatment was $67,891 (-$129,372 to $379,661). CONCLUSION: The proven non-inferiority of CAS versus CEA in high-surgical-risk patients with severe carotid stenosis might provide a marginal benefit that is offset by the higher cost associated with this procedure.