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Objectives: Despite the high prevalence of type 2 diabetes mellitus (T2DM), few data exist describing its management in Dubai. This study characterized the treatment and estimated levels of glycemic, lipid, and blood pressure control among a sample with T2DM at a large Dubai Hospital., Methods: This retrospective cohort study systematically sampled charts from adults seeking care for T2DM from October 2009 to March 2010 until the target (N = 250) was reached. Data on patient characteristics, pharmacotherapy, complications, and laboratory testing were abstracted until September 2011. The frequency of treatments and modifications over the period was calculated, and measures of glycosylated hemoglobin A 1c , low-density lipoprotein, and blood pressure control were compared with guideline targets. Frequencies of complications were compared according to treatment type., Results: One-third of the cohort comprised men, and the mean age was 58 years. At enrolment, the mean time from T2DM diagnosis was nearly 15 years and 74% had received insulin. During the study period, the most common regimens were insulin + oral combinations (55%) and oral combination therapy (39%). Overall, 67% received any insulin therapy during the study; and by study end, 78% had received insulin at any time. At the most recent assessment, guideline targets for glycosylated hemoglobin A 1c , blood pressure, and low-density lipoprotein were met by 23%, 29%, and 71%, respectively. Complications were more frequent among those treated with combination or insulin therapies., Conclusions: This study provides baseline data from Dubai for future comparisons of the effectiveness of new treatments, and to better understand the humanistic and economic burden of T2DM and its complications., (Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

The fetal time period is a critical window of immune system development and resulting heightened susceptibility to the adverse effects of environmental exposures. Epidemiologists and toxicologists have hypothesized that phthalates, bisphenol A (BPA) and perfluoroalkyl substance have immunotoxic properties. Immunotoxic effects of chemicals may manifest in an altered immune system profile at birth. Immunoglobulin E, thymic stromal lymphopoietin (TSLP), and interleukin-33 (IL-33) are integral in the etiology of childhood allergy and detectable at birth. The objective of this study was to determine the association between maternal levels of phthalates, bisphenol A (BPA), and perfluoroalkyl substances and elevated umbilical cord blood levels of IgE, TSLP, and IL-33. This study utilized data collected in the Maternal-Infant Research on Environmental Chemicals (MIREC) Study, a trans-Canada cohort study of 2001 pregnant women. Of these women, 1258 had a singleton, term birth and cord blood sample. A Bayesian hierarchical model was employed to determine associations between log-transformed continuous variables and immune system biomarkers while adjusting for potential confounding from correlated environmental contaminants. Inverse, nonlinear associations were observed between maternal urinary MCPP levels and elevated levels of both IL-33/TSLP and IgE and between maternal urinary BPA levels and elevated levels of IL-33/TSLP. In this primarily urban Canadian population of pregnant women and their newborns, maternal urinary and plasma concentrations of phthalate metabolites, BPA, and perfluoroalkyl substances were not associated with immunotoxic effects that manifest as increased odds of elevated levels of IgE, TSLP or IL-33., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: In spite of increases in short-term kidney transplant survival rates and reductions in acute rejection rates, increasing long-term graft survival rates remains a major challenge. The objective here was to project long-term graft- and survival-related outcomes occurring among renal transplant recipients based on short-term outcomes including acute rejection and estimated glomerular filtration rates observed in randomized trials., Methods: We developed a two-phase decision model including a trial phase and a Markov state transition phase to project long-term outcomes over the lifetimes of hypothetical renal graft recipients who survived the trial period with a functioning graft. Health states included functioning graft stratified by level of renal function, failed graft, functioning regraft, and death. Transitions between health states were predicted using statistical models that accounted for renal function, acute rejection, and new-onset diabetes after transplant and for donor and recipient predictors of long-term graft and patient survival. Models were estimated using data from 38,015 renal transplant recipients from the United States Renal Data System. The model was populated with data from a 3-year, randomized phase III trial comparing belatacept to cyclosporine., Results: The decision model was well calibrated with data from the United States Renal Data System. Long-term extrapolation of Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial was projected to yield a 1.9-year increase in time alive with a functioning graft and a 1.2 life-year increase over a 20-year time horizon., Conclusions: This is the first long-term follow-up model of renal transplant patients to be based on renal function, acute rejection, and new-onset diabetes. It is a useful tool for undertaking comparative effectiveness and cost-effectiveness studies of immunosuppressive medications., (Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objective: To estimate the societal economic burden of illness caused by surgically confirmed endometriosis in Canada in 2009, including direct health care costs, lost productivity, and lost leisure time costs., Methods: Using a cross-sectional design, direct health care resource use data were obtained from nine family physicians and nine gynaecologists from across Canada, who were experienced in the treatment of women with surgically confirmed endometriosis. Data on alternative treatments and health care providers, as well as work absenteeism, lost leisure time, and caregiver time were obtained from a convenience sample of 27 women with endometriosis treated at two gynaecology clinics in Alberta and Quebec. Unit costs were assigned to resource use items for treatment-seeking patients, and total costs for each resource use item were aggregated to estimate the societal costs of endometriosis in Canada in 2009, across all prevalent cases of surgically confirmed endometriosis., Results: The estimated mean annual societal cost of endometriosis was $5,200 per patient (95% CI $3,700 to $7,100), with lost productivity and lost leisure time costs accounting for 78%. Extrapolating these figures yields an estimated total annual cost to Canadian society of $1.8 billion (95% CI $1.3 billion to $2.4 billion) attributable to surgically confirmed endometriosis in Canada., Conclusion: For some women, surgically confirmed endometriosis has a substantial negative impact that can result in suffering to the individual and her family, and lead to substantial productivity losses. Understanding the interplay between direct costs, lost productivity, and quality of life is critical for accurately identifying and evaluating effective treatments for this condition.

Objectives: Chronic myelogenous leukemia (CML) is a progressive, largely fatal cancer. Emerging treatments may prolong life; however, these result in additional monetary costs. Accurate estimation of their economic impact requires reliable estimates on preferences for health states. The purpose was to estimate preference weights from the general population in four developed countries for standardized health states experienced by persons with CML., Methods: Time trade-off preferences with a 10-year time horizon were elicited for CML-related health states using an interviewer-administered survey from convenience samples in Canada (n=103), the United States (n=74), the UK (n=97), and Australia (n=79). Standardized descriptions of seven CML-related health states (characterizing chronic, accelerated and blast phases, each with responding and nonresponding state, and adverse events of treatment) were derived in consultation with oncologists. Generalized linear models were used to estimate whether utilities, adjusted for age and sex, differed by country., Results: The mean age of the sample (n=357) was 45 years and 46% were male. Mean unadjusted preference values of CML-related health states ranged from 0.84 for "Chronic phase responding to treatment" to 0.21 for "Blast phase, not responding to treatment." For each phase, preferences were lower for the nonresponding state. After adjustment for age and sex, considerable variability was observed in mean preference values between countries., Conclusion: These data quantify the deteriorating impact of CML disease progression and the impact of nonresponse to treatment. The study results add to evidence from other disease areas that systematic differences exist in preference values between countries.

Objectives: Solid organ transplantations are among the most expensive treatments yet relatively few investigators have reported well-characterized and reliable information on costs. The objective here was to compare the direct medical costs of kidney, liver, heart, and lung transplantations in British Columbia (BC), Canada., Methods: Using data from a province-wide population-based registry, resource utilization data were collated for 1333 patients who underwent solid organ transplantation between 1995 and 2003. Resource categories included hospital stays, physician fees, laboratory and diagnostic testing, and immunosuppressants. Mean costs (2003 $CDN) were derived for the index hospitalization and each of the 2 years after hospital discharge. To enable valid comparisons, the same costing methodology was applied to all four programs., Results: The mean costs of transplantation varied from $27,695 for kidney recipients to $89,942 for lung recipients, with inpatient hospital stays comprising the largest component. Mean costs for the first and second follow-up years ranged from $27,592 and $11,424 for lung recipients to $21,144 and $8086 for liver recipients. Immunosuppressants accounted for between two-thirds and three-fourths of costs by the second year. Within each program, variations in costs could not be accounted for by demographic factors., Conclusions: We observed in BC a threefold variation in mean costs of organ transplantation procedures, with the variations between programs diminishing during follow-up. Policymakers and decision-makers seeking to better understand the deployment of resources for transplantation may focus on clinical factors at the time of hospitalization and factors that influence use and costs of immunosuppressants during the induction and maintenance phases.

Objectives: Chronic hepatitis B (CHB) is a condition that results in substantial morbidity and mortality worldwide because of progressive liver damage. Investigators undertaking economic evaluations of new therapeutic agents require estimates of health-related quality of life (HRQOL). Recently, evidence has begun to accumulate that differences in cultural backgrounds have a quantifiable impact on perceptions of health. The objective was to elicit utilities for six health states that occur after infection with the hepatitis B virus from infected and uninfected respondents living in jurisdictions with low and with high CHB endemicity., Methods: Standard gamble utilities were elicited from hepatitis patients and uninfected respondents using an interviewer-administered survey in the United States, Canada, United Kingdom, Spain, Hong Kong, and mainland China. Generalized linear models were used to the effect on utilities of current health, age and sex, jurisdiction and, for infected respondents, current disease state., Results: The sample included 534 CHB-infected patients and 600 uninfected respondents. CHB and compensated cirrhosis had a moderate impact on HRQOL with utilities ranging from 0.68 to 0.80. Decompensated cirrhosis and hepatocellular carcinoma had a stronger impact with utilities ranging from 0.35 to 0.41. Significant variation was observed between countries, with both types of respondents in mainland China and Hong Kong reporting systematically lower utilities., Conclusions: Health states related to CHB infection have substantial reductions in HRQOL and the utilities reported in this study provide valuable information for comparing new treatment options. The observed intercountry differences suggest that economic evaluations may benefit from country-specific utility estimates. The extent that systematic intercountry differences in utilities hold true for other infectious and chronic diseases remains an open question and has considerable implications for the proper conduct and interpretation of economic evaluations.

Objectives: Losses to follow-up and administrative censoring can cloud the interpretation of trial-based economic evaluations. A number of investigators have examined the impact of different levels of adjustment for censoring, including nonadjustment, adjustment of effects only, and adjustment for both costs and effects. Nevertheless, there is a lack of research on the impact of censoring on decision-making. The objective of this study was to estimate the impact of adjustment for censoring on the interpretation of cost-effectiveness results and expected value of perfect information (EVPI), using a trial-based analysis that compared rate- and rhythm-control treatments for persons with atrial fibrillation., Methods: Three different levels of adjustment for censoring were examined: no censoring of cost and effects, censoring of effects only, and censoring of both costs and effects. In each case, bootstrapping was used to estimate the uncertainty incosts and effects, and the EVPI was calculated to determine the potential worth of further research., Results: Censoring did not impact the adoption decision. Nevertheless, this was not the case for the decision uncertainty or the EVPI. For a threshold of $50,000 per life-year, the EVPI varied between $626,000 (partial censoring) to $117 million (full censoring) for the eligible US population., Conclusions: The level of adjustment for censoring in trial-based cost-effectiveness analyses can impact on the decisions to fund a new technology and to devote resources for further research. Only when censoring is taken into account for both costs and effects are these decisions appropriately addressed.

Objective: In the analysis of observational data, the argument is sometimes made that if adjustment for measured confounders induces little change in the treatment-outcome association, then there is less concern about the extent to which the association is driven by unmeasured confounding. We quantify this reasoning using Bayesian sensitivity analysis (BSA) for unmeasured confounding. Using hierarchical models, the confounding effect of a binary unmeasured variable is modeled as arising from the same distribution as that of measured confounders. Our objective is to investigate the performance of the method compared to sensitivity analysis, which assumes that there is no relationship between measured and unmeasured confounders., Study Design and Setting: We apply the method in an observational study of the effectiveness of beta-blocker therapy in heart failure patients., Results: BSA for unmeasured confounding using hierarchical prior distributions yields an odds ratio (OR) of 0.72, 95% credible interval (CrI): 0.56, 0.93 for the association between beta-blockers and mortality, whereas using independent priors yields OR=0.72, 95% CrI: 0.45, 1.15., Conclusion: If the confounding effect of a binary unmeasured variable is similar to that of measured confounders, then conventional sensitivity analysis may give results that overstate the uncertainty about bias.

Objectives: In light of recent results from observational studies showing prolonged survival in subjects taking long-acting beta2-agonists (LABA) and/or inhaled corticosteroids (ICS) for chronic obstructive pulmonary disease (COPD), we investigated their cost-effectiveness (CE)., Methods: Costs and survival data were collected for a sample of members enrolled in a large Health Maintenance Organization in the United States. An observational study design was used to evaluate cumulative costs and health benefits of LABA, ICS, ICS+LABA, or comparison drugs. Survival was estimated using a parametric regression model. Costs were adjusted for censoring and prognostic factors. CE was evaluated over a time horizon of 36 months and the remaining lifetime of subjects., Results: Over 36 months, life expectancy and costs were: 2.4 years (95% confidence interval (CI): 2.3; 2.5) and $28,030 (CI: $23,400; $33,570) for not receiving ICS or LABA; 2.6 years (CI: 2.6; 2.7) and $35,170 (CI: $29,970; $40,620) for ICS alone; 2.6 years (CI: 2.5; 2.7) and $27,380 (CI: $21,780; $32,510) for LABA alone; and, 2.7 years (CI: 2.6; 2.8) and $33,780 (CI: $28,700; $39,440) for subjects treated with ICS+LABA. The lifetime analysis showed similar trends., Conclusions: There is an acute need to find effective, life-extending treatments for persons with COPD. ICS, LABA or their combination represent promising treatment options and are currently being tested in randomized trials. If the impact on survival seen in these trials compares to that seen in observational studies, LABA and the combination treatment are likely to be cost-effective in the United States.

Objectives: Administering proton pump inhibitors (PPI) intravenously (iv) after endoscopic treatment of bleeding peptic ulcers reduces the incidence of rebleeding, the need for operative procedures, and hospitalizations. We assessed the cost implications of iv PPI initiated in all patients presenting to the emergency department (ED) with signs of upper gastrointestinal (UGI) bleeding., Methods: From a third-party payer perspective with a time horizon of 60 days, we built a decision analytic model comparing standard endoscopic therapy to a strategy in which all patients presenting to the ED with UGI bleeding would start iv PPI before endoscopy. After endoscopy, only those with peptic ulcers would be kept on iv PPI added to standard therapy. Probabilities of health events were extracted from published literature. Resource utilization profiles and costs (iv PPI, hospital stay for medical and operative procedures, and professional fees) were based on Medicare reimbursement data from a large hospital in Alabama. All costs were expressed in 2000 US dollars. Uncertainty was investigated through one-way sensitivity analyses and probabilistic analyses using Monte Carlo simulations., Results: In a hypothetical group of 1000 individuals, routine use of iv PPI prevented 40 rebleeds, 9 surgical procedures, and 223 hospital days, and led to incremental savings of dollars 920 per subject. Probabilistic sensitivity analyses indicated that the strategy of using iv PPI was likely to be dominant even when accounting for uncertainty., Conclusions: Based on available evidence, routine administration of iv PPI to all persons presenting with UGI bleeding represents good value for money and merits consideration as standard hospital policy.

Background: The Ontario government spent approximately 10% (CDN $148 million) of the provincial medication budget on statins in 1998. This number can be expected to grow in light of new guidelines from the United States recommending that three times as many patients should be receiving antihyperlipidemic therapy. There is scant population-based information on the age and sex distributions of patients receiving these medications., Objectives: To estimate the rates of new use of statin medications among community-dwelling elderly adults in Ontario between 1994 and 2000., Methods: Data from the Ontario Drug Benefit program were used on all medications dispensed to noninstitutionalized Ontarians over 65 years of age to estimate age- and sex-specific annual rates of patients newly dispensed a statin. Changes in rates were estimated using Poisson regression., Results: The number of elderly Ontarians newly dispensed a statin increased rapidly between 1994 and 2000, with age-standardized rates rising from approximately 840 to 2600/100,000 women and from 810 to about 3100/100,000 men. The highest rates of new use were observed among patients of both sexes aged 65 to 74 years. However, the rate of change increased with advancing age so that the biggest increase was observed among those aged 85 years and above, among whom there was an 8.5-fold increase among women and a 12-fold increase among men., Conclusions: Statins have been shown to be safe, efficacious and cost effective in reducing the risk of sudden cardiac death and other acute coronary events among middle-aged patients with pre-existing cardiovascular disease. The present study showed that there was a rapid increase in the rate of statins newly dispensed to elderly patients in Ontario, among whom estimates of safety, efficacy and cost effectiveness are not well quantified. Better estimates of these parameters in the elderly are required because of the high costs and benefits and potential unintended beneficial and harmful effects of statins.

Purpose: The objective was to determine whether the year and medical school of graduation, the medical specialty and the sex of the treating physician was associated with prescribing beta-blockers after hospital discharge among survivors of myocardial infarction (MI), after adjusting for patient characteristics., Methods: We carried out a dynamic retrospective cohort study using data from a longitudinal database that contained information on Quebec residents over the age of 65 years sent home from hospital after MI between 1990 and 1993. The outcome was a beta-blocker being dispensed after hospital discharge. Logistic regression was used to estimate the association between training characteristics and beta-blocker dispensation and clustering of patients within physicians was accounted for using Generalized Estimating Equations., Results: The cohort consisted of 14,334 MI survivors who were treated by 3209 physicians, yielding a mean of about 4.5 patients per physician [standard deviation (SD) = 8.2]. Beta-blockers were prescribed to approximately one-third of subjects. After adjusting for patients' demographic characteristics, comorbid medical conditions, and markers of MI severity, physicians who were more likely to prescribe a beta-blocker included cardiologists and the most recent graduates (graduating after 1989). Systematic differences were also observed between graduates of different medical schools., Conclusions: After adjusting for differences between patients', the sex of the physician was largely unrelated to prescribing beta-blockers for secondary prevention of MI. However, prescribing differed by training characteristics such as medical specialty and year and medical school of graduation.

Objective: To assess the coding accuracy of primary and secondary discharge diagnoses in the Quebec hospital discharge database for elderly persons with myocardial infarction (MI)., Design: Retrospective chart review in a convenience sample of six Montreal hospitals. The diagnoses listed in the medical chart were compared with those listed in the hospital discharge database. For each subject, the Charlson comorbidity index was calculated twice, once based on the medical chart and again based on the hospital discharge database., Patients: Subjects aged 65 years and over who had an MI coded as the primary discharge diagnosis in the hospital discharge database and who were discharged alive., Main Results: For 234 MI survivors, the positive predictive value (ie, probability that a patient with MI reported in the hospital discharge database had an MI diagnosed by the discharging physician) for coding MI was 0.96 (95% CI 0.94, 0.98). Comorbid medical conditions and complications of the MI were under-reported in the hospital discharge database, which meant that the Charlson index based on the hospital discharge database was an average of 0.71 units lower than the Charlson index based on the medical chart., Conclusions: When studying survivors of MI by using hospital discharge databases, the advantages must be weighed against potential drawbacks in the quality of the information. Hospital discharge databases are almost as reliable as medical charts for identifying MI patients, but there is substantial under-reporting of comorbid medical conditions.