Cost-effectiveness of a primary care intervention to treat obesity.

BACKGROUND: Data on the cost-effectiveness of the behavioral treatment of obesity are not conclusive. The cost-effectiveness of treatment in primary care settings is particularly relevant. METHODS: We conducted a within-trial cost-effectiveness analysis of a primary care-based obesity intervention. Study participants were randomized to: Usual Care (UC; quarterly visits with their primary care provider); Brief Lifestyle Counseling (BLC; quarterly provider visits plus monthly weight loss counseling visits) or Enhanced Brief Lifestyle Counseling (EBLC; all above interventions, plus choice of meal replacements or weight loss medication). A health-care payer perspective was used. Intervention costs were estimated from tracking data obtained prospectively. Quality-adjusted life years (QALYs) were estimated with the EuroQol-5D. We estimated cost per kilogram-year of weight loss and cost per QALY. RESULTS: Weight losses after 2 years were 1.7, 2.9 and 4.6 kg for UC, BLC and EBLC, respectively (P=0.003 for comparison of EBLC vs UC). The incremental cost per kilogram-year lost was $292 for EBLC compared with UC (95% confidence interval (CI): $219-$437). The short-term incremental cost per QALY was $115,397, but the 95% CI were undefined. Comparison of short-term cost per kg with published estimates of longer-term cost per QALY suggested that the intervention could be cost-effective over the long term (≥ 10 years). CONCLUSIONS: A primary care intervention that includes monthly counseling visits and a choice of meal replacements or weight loss medication could be a cost-effective treatment for obesity over the long term. However, additional studies are needed on the cost-effectiveness of behavioral treatment of obesity.

Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study.

The TOwards a Revolution in COPD Health (TORCH) study was a 3-yr multicentre trial of 6,112 patients randomised to salmeterol (Salm), fluticasone propionate (FP), a Salm/FP combination (SFC) or placebo (P). Here the cost-effectiveness of treatments evaluated in the TORCH study is assessed. For four regions, 3-yr all-cause hospitalisation, medication and outpatient care costs were calculated. The sample was restricted to the 21 countries (n = 4,237) in which European quality of life five-dimension (EQ-5D) data were collected in order to estimate the number of quality-adjusted life years (QALYs). Regression models were fitted to survival, study medication cost, other medication cost and EQ-5D data in order to estimate total cost, number of QALYs and cost per QALY, adjusted for missing data and region. SFC had a trial-wide estimate of cost per QALY of 43,600 US dollars (USD) compared with P (95% confidence interval 21,400-123,500 USD). Estimates for Salm versus P (197,000 USD) and FP versus P (78,000 USD) were less favourable. The US estimates were greater than those from other regions; for SFC versus P, the cost per QALY was 77,100 (46,200-241,700) USD compared to 24,200 (15,200-56,100) USD in Western Europe. Compared with P, SFC has a lower incremental cost-effectiveness ratio than either FP or Salm used alone, and is, therefore, preferred to these monotherapies on the grounds of cost-effectiveness.

Determining an episode of care using claims data. Diabetic foot ulcer.

OBJECTIVE: Amid changes in the organization and financing of health care, health care decision makers are increasingly interested in episodes of care. We sought to determine an episode of care for diabetic foot ulcer using an administrative claims database. RESEARCH DESIGN AND METHODS: We used 1993-1995 claims data to assess resource utilization for privately insured patients with diabetic foot ulcers. Over a 26-week period, we determined the episode length by comparing differences in average daily charges and proportion of patients with charges before and after foot ulcer diagnosis. All 13 weeks before diagnosis were used to calculate baseline values. Significance was determined by CIs, which were calculated by a nonparametric bootstrap technique. Costs associated with the episode were also calculated. A sensitivity analysis using weeks with highest and lowest values as baseline was also conducted. RESULTS: Based on average daily charges, the episode of care for diabetic foot ulcer was 5 weeks. Using proportion of patients with charges, the episode was longer than 13 weeks. The cost for an episode of care ranged from $900 to $2,600. In the sensitivity analyses, episodes of care ranged from 1 to 13 weeks. CONCLUSIONS: Episodes of care can be defined by the period beginning with increased resource consumption and ending when resource consumption returns to baseline levels. With the growth of managed care and disease management programs, episode-of-care analysis may have an increasingly important role in health care provision and delivery.

Economic evaluation of high-dose chemotherapy and bone marrow transplantation for patients with breast cancer of stage II or IIIA with more than 10 positive lymph nodes at surgical excision.

Several issues related to the design of a multi-year study of the outcome of high-dose chemotherapy with bone marrow transplant for patients with metastatic breast cancer have been discussed. Important considerations include an understanding of the types of data that would be collected through the study period, an assessment of treatment benefits and complications, an understanding of the valuation of differences in resource consumption across treatment arms, and an informed definition of the study population to include in the economic assessment. The resulting analysis will help patients and policy makers better understand the impact of aggressive treatment options for breast cancer patients.

Introduction to clinical economics: assessment of cancer therapies.

Recent changes in the health care environment have led to the assessment of the costs and benefits of cancer treatment as criteria for the evaluation of new cancer therapies. The methodological framework for these assessments is provided by the field of clinical economics, a discipline that combines the techniques from clinical medicine, economics, epidemiology, and biostatistics. This article reviews the concepts of clinical economics and issues related to economic analysis of new therapies. This type of information is increasingly important to patients, clinicians, and health policy decision makers to help assure patients' access to effective cancer therapies.

Clinical economics in clinical trials: the measurement of cost and outcomes in the assessment of clinical services through clinical trials.

As the population ages and more expensive high-technology services become available, health care costs continue to spiral upward. Because the financial resources for health care are limited, economic analysis can help to evaluate expenditures and set priorities. Economic analysis of medical technology or medical care evaluates a medical service by comparing its dollar cost with its dollar benefit (cost-benefit), by measuring its dollar cost in relation to its outcomes (cost-effectiveness) as well as in relation to its utility or quality-adjusted outcomes (cost-utility), or simply by tabulating the costs involved (cost-identification). Direct costs are generated as services are provided. In addition, patients' productivity is affected, and these costs can be considered, especially in determining the benefit of a service that decreases morbidity or mortality. Intangible costs are those of pain, suffering, and grief. The point of view, or perspective, of the study determines the costs and benefits that will be measured in the analysis. Sensitivity analysis, which can evaluate the stability of the conclusions to the data used, is an important assessment within economic analysis. Economic analysis of new pharmaceutical therapies is increasingly being incorporated into clinical trials. Although there are some limitations of pharmacoeconomic information in clinical studies of drug safety and efficacy, these trials are often the only opportunity for economic data collection before adoption and reimbursement decisions are made. Validation after the drug has been introduced should complement economic information developed from clinical trials.

Prospective economic evaluation accompanying a trial of GM-CSF/IL-3 in patients undergoing autologous bone marrow transplantation for Hodgkin's and non-Hodgkin's lymphoma. IL-3 BMT Study Team.

Our objective was to assess the economic impact of a new cytokine therapy that was being compared to standard therapy as supportive care in patients receiving autologous bone marrow transplantation for treatment of lymphoma. We performed an economic study accompanying a multicenter, randomized, controlled clinical trial in academic medical centers. One hundred and fifteen patients consented to participate in a parallel economic study of a randomized controlled trial of sequential IL-3 followed by GM-CSF vs GM-CSF alone after autologous bone marrow transplantation. We measured costs and quality-adjusted survival over a 13-month follow-up period. For the 13-month study period, the total cost estimates were $79892 (95% CI $69343 to $90544) for patients receiving GM-CSF alone and $89651 (95% CI $79769 to $102114) for patients receiving IL-3/GM-CSF. The difference was not statistically significant. During the 13-month study period, the total number of quality-adjusted life-months in the GM-CSF arm was 6.67 (95% CI 5.75 to 7.56) months, while the total number of quality-adjusted life-months in the IL-3 arm was 6.26 (95% CI 5.34 to 7.15) months. The difference in quality-adjusted life-months between the two treatment arms was not statistically significant. We conclude that economic analysis of a phase III clinical trial of IL-3/GM-CSF compared with GM-CSF alone showed no significant effect of IL-3 on the costs of care for patients undergoing bone marrow transplantation for a period of up to 13 months after the procedure. This study demonstrates the feasibility of prospective economic evaluation within phase III trials of new cancer therapies. Data from this type of economic protocol could be used to help physicians, patients and managed care organizations understand the effect of new treatments from both a clinical and an economic perspective.

Economic analysis of conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer.

We performed an economic analysis of data from 180 women in a clinical trial of conventional-dose chemotherapy vs high-dose chemotherapy plus stem-cell transplantation for metastatic breast cancer responding to first-line chemotherapy. Data on resource use, including hospitalizations, medical procedures, medications, and diagnostic tests, were abstracted from subjects' clinical trial records. Resources were valued using the Medicare Fee Schedule for inpatient costs at one academic medical center and average wholesale prices for medications. Monthly costs were calculated and stratified by treatment group and clinical phase. Mean follow-up was 690 days in the transplantation group and 758 days in the conventional-dose chemotherapy group. Subjects in the transplantation group were hospitalized for more days (28.6 vs 17.8, P=0.0041) and incurred higher costs (US dollars 84055 vs US dollars 28169) than subjects receiving conventional-dose chemotherapy, with a mean difference of US dollars 55886 (95% CI, US dollars 47298-US dollars 63666). Sensitivity analyses resulted in cost differences between the treatment groups from US dollars 36528 to US dollars 75531. High-dose chemotherapy plus stem-cell transplantation resulted in substantial additional morbidity and costs at no improvement in survival. Neither the survival results nor the economic findings support the use of this procedure outside of the clinical trial setting.

Predicting 10-year care requirements for older people with suspected Alzheimer's disease.

OBJECTIVE: To describe the types and costs of care received for 10 years after the identification of an older person with suspected Alzheimer's disease (AD) by using data from 3254 patients with suspected AD who participated in the National Long Term Care Survey (NLTCS). METHODS: By using a Markov model derived using grade of membership techniques, the following were determined: survival probabilities at 10 years; years of survival during the 10 years; years in institutions; years with two or more impairments in basic activities of daily living; hours of paid and informal care while the older person lived in the community; and costs of paid community, institutional, and medical care. RESULTS: Greater degrees of cognitive impairment present when AD was identified were associated with reduced predicted probability of surviving 10 years, increased predicted number of years spent in institutions, increased hours of care required while affected individuals remained in the community, and increased costs of paid community, institutional, and medical care. Substantial differences between men and women were seen: severity-adjusted 10-year costs were almost two times higher for women with AD than for men ($75,000 compared with $44,000); according to sensitivity analysis, average 10-year costs might be as high as $109,000 for women and $67,000 for men. CONCLUSIONS: AD imposes a substantial burden on older persons. Interventions that slow the progression of the disease may therefore affect community survival as well as healthcare costs.

The cost and cardioprotective effects of enalapril in hypertensive patients with left ventricular dysfunction.

This study examined the effect of enalapril on survival, resource use, and cost of care in patients with left ventricular dysfunction and hypertension using a retrospective analysis of patients who participated in the Studies of Left Ventricular Dysfunction (SOLVD). Among the 6797 SOLVD participants, 1917 patients had either elevated systolic (> or = 140 mm Hg) or diastolic (> or = 90 mm Hg) blood pressure. Therapy with enalapril was associated with a significant relative risk reduction for mortality (RR = 0.819, 95% CI: 0.68 to 0.98; P = .03). This resulted in a gain of 0.11 years (95% CI: 0.00 to 0.20 years) of survival during the average 2.8 year follow-up for this subgroup and was projected to result in a gain of 2.14 years (95% CI: 0.05 to 4.21 years) during the patient's lifetime. Enalapril significantly reduced the risk of first hospitalization for heart failure by 37%. For all types of hospitalizations, there was an average reduction of 32 hospitalizations per 100 patients treated with enalapril during the trial period (95% CI: 11.8 to 52.2 hospitalizations avoided per 100 patients), resulting in an estimated net savings of $1656 per patient during the trial period (95% CI: increased cost of $191 to savings of $3502). Although the projected lifetime net savings of $1456 was not significant (95% CI: increased cost of $9243 to saving of $12,527), evaluation of the cost per life year saved indicated that enalapril represented a cost-effective strategy. The estimated clinical benefit of enalapril among the hypertensive subgroup in SOLVD supports the recommendation that angiotensin converting enzyme (ACE) inhibitors should be considered as first line pharmacologic therapy for hypertensive patients with left ventricular dysfunction. From both the clinical and economic viewpoints, ACE inhibitors provide important clinical benefits and are cost-effective.

Clinical and economic impact of a combination Haemophilus influenzae and Hepatitis B vaccine: estimating cost-effectiveness using decision analysis.

BACKGROUND: Compliance with hepatitis B virus (HBV) vaccine remains suboptimal, despite a recommendation by the Advisory Committee on Immunization Practices of the US Public Health Service that all newborns be vaccinated. Although a combined HBV-Haemophilus influenzae type b (Hib) vaccine may improve acceptance of the HBV vaccine, the clinical and economic consequences of this intervention are uncertain. OBJECTIVES: To compare the health impact and cost-effectiveness of the following 2 immunization strategies: current practice of administering HBV vaccine separately (75% compliance) and Hib vaccine alone or as part of a multivalent vaccine (95% compliance); and strategy of delivering a combined HBV-Hib vaccine (95% compliance). DESIGN: A Markov model simulated the natural history of acute and chronic HBV and Hib disease in a cohort of US newborns. Clinical and economic variables were obtained from published reports. RESULTS: The Hib-related outcomes were the same in both strategies, because the efficacy and compliance with Hib vaccine were assumed to be equivalent in both. A 53% reduction in the number of cases of HBV infection with the combination strategy (n = 8541) was estimated when compared with current practice (n = 18 044), along with 205 fewer HBV-related deaths per 1 million infants. Immunization costs of the combination strategy were $11.5 million higher than for current practice ($108.4 million compared with $96.9 million), whereas the cost of HBV-related disease was $4.0 million lower than in current practice. The incremental cost-effectiveness ratio for the combination strategy was $17700 per year of life saved. CONCLUSION: An HBV-Hib vaccine in US infants yields substantial benefits, with a cost-effectiveness ratio that is lower than that of many commonly used medical interventions.

Effect of cooking fuels on respiratory diseases in preschool children in Lucknow, India.

The association between cooking fuels and the risk of respiratory disease in preschool children in Lucknow, India was studied. We interviewed mothers of 650 study children, randomly selected from among 28 urban poor neighborhoods. Children were eligible if they were less than five years of age, free of congenital heart disease, malignancy, and compromised immune status. Respiratory disease (defined as one or more of the following: runny nose, cough, sore throat, breathlessness, and noisy respiration) was assessed by observation. Exposures included the types of cooking fuels and duration of their use in the last week and other potential predictors of respiratory disease. Odds ratios (ORs) for disease were adjusted for covariables using multiple logistic regression. The point prevalence of respiratory disease was 14.5%. Cooking fuels used were wood (56.0%), kerosene (24.2%), coal (19.2%), gas (15.4%), and dung cakes (8.6%). Use of dung cakes, a sun-dried mixture of cow or buffalo dung and straw, as cooking fuel was associated with respiratory disease (adjusted OR = 2.69, 95% confidence interval [CI] = 1.37-5.31, P = 0.004), as was overcrowding in the bedroom (adjusted OR = 1.25 for each additional person, 95% CI = 1.11-1.41, P = 0.001). Age, weight, gender, family income, and household structure were not associated with disease. Use of dung cakes as cooking fuel and overcrowding in the bedroom increased the risk of respiratory disease. Interventions to modify oven design or install chimneys and, where feasible, to reduce the number of people sleeping together should be considered.

Quality of life effects of alprostadil therapy for erectile dysfunction: results of a trial in Europe and South Africa.

OBJECTIVES: Quality of life (QOL) data were used to evaluate the effects of self-administered intracavernosal injection of alprostadil for erectile dysfunction, when used for up to 18 months during a 13 country Phase III clinical trial. METHODS: The Duke Health Profile was used to measure patients' physical and psychosocial QOL at baseline, 3, 6, 12 and 18 months. Changes from baseline were measured using paired t-tests, with additional analyses by cause of dysfunction, starting dosage, and prior treatment. RESULTS: Patients displayed significant improvements in mental and social health and self-esteem at six months (P < 0.01, n = 570), with greater improvements at 12 and 18 months. Anxiety and depression measures also improved significantly at 12 and 18 months, as did the summary general health score. Worse pain scores were observed in the first year but not at 18 months. Those with a starting dosage of 10-20 micrograms, those with psychogenic causes of dysfunction, and those with no prior treatment for erectile dysfunction generally showed the greatest improvements. CONCLUSION: In this study, the clinical improvements in erectile function due to intracavernosal alprostadil therapy were complemented by QOL improvements, particularly in the mental health, of many patients.

Comparison of length of hospital stay for patients with known or suspected methicillin-resistant Staphylococcus species infections treated with linezolid or vancomycin: a randomized, multicenter trial.

STUDY OBJECTIVE: To compare hospital length of stay (LOS), weekly discharges, and days of antibiotic treatment with linezolid (intravenous with oral follow-up) and vancomycin (intravenous only). DESIGN: Multinational, randomized, phase III trial. SETTINGS: Hospitals in North America, Latin America, and Europe. PATIENTS: Four hundred sixty hospitalized patients with infections of known or suspected methicillin-resistant Staphylococcus species. INTERVENTION: Administration of linezolid or vancomycin. MEASUREMENTS AND MAIN RESULTS: For linezolid recipients, median LOS was 5 and 8 days shorter (p=0.05 and 0.003) in the complicated skin and soft tissue infection intent-to-treat (230 patients) and clinically evaluable (144) samples, and slightly but not significantly shorter in the overall intent-to-treat (460) and clinically evaluable (254) samples. In all samples, linezolid recipients had more discharges in the first week of treatment and fewer days of intravenous therapy than vancomycin recipients. CONCLUSION: Our results support linezolid's ability to reduce medical resource use.

Elective surgery for asymptomatic, unruptured, intracranial aneurysms: a cost-effectiveness analysis.

Cost-effectiveness analysis uses both economic and clinical outcomes data to evaluate treatment options. In this era of economic constraints on health care, treatments that are not cost-effective will increasingly be denied public and private insurance reimbursement. The authors used mathematical modeling techniques to assess the cost-effectiveness of elective surgery for the treatment of asymptomatic, unruptured, intracranial aneurysms. Input values for the Markov model used in this study were determined from both the literature and clinical judgment. Direct medical costs for hospitalization and physician fees were derived from Medicare cost reports and resource-based relative-value units, expressed in 1992 U.S. dollars. Costs and benefits were discounted at an annual rate of 5%. Using baseline model assumptions for a 50-year-old patient, elective aneurysm surgery provides an average of 0.88 additional quality-adjusted life years (QALYs) compared with nonsurgical treatment. However, prompt elective surgery ($23,300) costs more than expectant management ($2100), in which only patients whose aneurysms rupture incur treatment costs. Combining the outcomes and cost data, the incremental cost-effectiveness of elective aneurysm surgery is $24,200 per QALY, which is comparable to other accepted medical or surgical interventions, such as total knee arthroplasty ($15,200/QALY) or antihypertensive therapy in a 50-year-old patient ($29,800/QALY). Prompt elective surgery for asymptomatic, unruptured, intracranial aneurysms is recommended as a cost-effective use of medical resources provided: 1) surgical morbidity and mortality remain at reported levels; 2) the patient has a life expectancy of at least 13 additional years; and 3) the patient experiences a decrease in quality of life from knowingly living with an unruptured aneurysm.

Relationships between sponsors and investigators in pharmacoeconomic and clinical research.

Potential conflict between the goals of the investigators and the sponsors of pharmacoeconomic and clinical research has been well documented. Although there have been efforts to formalise relationships between sponsors and investigators in some areas of clinical research, no set of guidelines or standardised contract to govern pharmacoeconomic research relationships is currently in use. In this paper, we discuss a number of provisions that should be included in a sponsored research agreement to define the responsibilities and clarify the rights of the parties in the collaborative research relationship. We also present an example of a sponsored research agreement that we have designed as a model formal contract between sponsors and investigators. The most salient areas in the research agreement include: publication, specification of analysis, data access/ownership, confidentiality, termination and payment to investigators. While this paper focuses on pharmacoeconomic research, many of the principles have relevance to a broader range of research relationships and to other clinical economics and clinical trials research.

A comparison of preference assessment instruments used in a clinical trial: responses to the visual analog scale from the EuroQol EQ-5D and the Health Utilities Index.

OBJECTIVES: To compare preference assessments that were made by using the EuroQol EQ-5D and the Health Utilities Index Mark II. SUBJECTS: 561 patients in a randomized trial of tirilazad mesylate for aneurysmal subarachnoid hemorrhage. MEASURES: Three preference assessments (a value score for the EuroQol instrument and value and utility scores for the Health Utilities Index) made three months after randomization. The averages for each of the three scores, stratified by clinical outcomes and attributes of the Health Utilities Index health status classification system, were compared. To evaluate potential sources of difference between the instruments, the authors estimated two alternative Health Utilities Index scoring rules that were based on patient responses to the EuroQol instrument. RESULTS: Patients' ratings of their current health made by using the 100-point visual analog scale from the EuroQol instrument were more similar to the utility scores for the Health Utilities Index than they were to the value scores for the Health Utilities Index. The biggest differences between the visual analog scores for the EuroQol instrument and the utility scores for the Health Utilities index were seen at higher levels of functioning. CONCLUSION: For states representing higher levels of functioning, differences were seen between patients' self-ratings obtained by using the EuroQol instrument and the patients' utility scores on the Health Utilities Index; for states representing lower levels of functioning, substantial agreement was observed between these two scores. Differences observed at the higher levels of functioning suggest that further research is needed to determine whether the Health Utility Index's assignment of a score of 1.0 to the reference state representing being healthy is appropriate.

Does perioperative total parenteral nutrition reduce medical care costs?

An economic analysis accompanied a multicenter Department of Veterans Affairs randomized, controlled trial of perioperative total parenteral nutrition (TPN). The cost of providing TPN for an average of 16.15 days before and after surgery was $2405, more than half of which ($1025) included costs of purchasing, preparing, and delivering the TPN solution itself; lipid solutions accounted for another $181, additional nursing care for $843, and miscellaneous costs for $356. Prolonged hospital stay added another $764 per patient to the $2405 cost of providing TPN, bringing the total to $3169. The incremental costs attributed to perioperative TPN were highest ($3921) for the patients least likely to benefit, that is, those who were less malnourished and at low risk of nutrition-related complications. Incremental costs were lowest ($3071) for high-risk patients. On the basis of the hospital-based method of administering TPN that was used in the clinical trial, perioperative TPN did not result in decreased costs for any subgroup of patients.

Ambient air pollution & respiratory symptoms complex in preschool children.

To study the association between ambient air pollutants (AAP) and respiratory symptoms complex (RSC) in preschool children, a cohort of 664 children between the ages of 1 month to 4.5 yr were randomly selected from 28 slums (anganwadi centres) of Lucknow, north India. They were followed up fortnightly for six months. The outcomes assessed were presence of RSC at the time of interview and days on which symptoms had occurred in the past week. Exposure to ambient air sulphur dioxide (SO2), oxides of nitrogen (NOx) and suspended particulate matter (SPM) on the day of the interview or in the week prior, was assessed by ambient air monitoring at 9 centres within the city. The cumulative incidence of RSC was 1.06 and the incidence density per 100 days of follow up was 1.63. All three pollutants were positively correlated with each other and negatively correlated with temperature. Ambient air SPM and SO2 and cooking and heating fuels like dung cakes, wood, coal and kerosene and remaining indoors while the food was cooked were associated with increased incidence of RSC, increased duration of symptoms, or both. We conclude that to improve the respiratory health of preschool children, ambient air SPM and SO2 levels should be kept as low as possible and mothers should be advised to keep children in another room while cooking.

Re-examining the BMI threshold for bariatric surgery in the USA.

BACKGROUND: The optimal BMI threshold above which gastric bypass surgery should be offered to obese patients is controversial. The objective of this study was to compare the impact of Roux-en-Y gastric bypass (RYGB) vs. diet and exercise (D&E) on life expectancy to find the BMI at which patients experience an improvement in their life expectancy by undergoing surgery. METHODS: A Markov state transition model was designed to implement a decision tree that simulated the lives of obese patients. Life expectancies following RYGB and 2 years of D&E were estimated and compared. Ten thousand patients' lives were simulated in each weight-loss intervention group in the model. In addition to base case analysis (45 kg/m(2) BMI pre-intervention), sensitivity analysis of initial BMI at the start of the study was completed. Markov model parameters were extracted from the literature. RESULTS: The impact of RYGB on survival relative to D&E depended on the patient's initial BMI. Compared to patients who underwent 2 years of "optimal" diet and exercise (7 % total body weight loss/year), RYGB improved long-term survival for patients above a BMI of 31.3 kg/m(2). CONCLUSIONS: Roux-en-Y gastric bypass can improve long-term survival for patients with class I obesity. This study suggests that RYGB should not be reserved solely for patients with class II or III obesity.