Economic Analysis of a Diabetes Health Coaching Intervention for Adults Living With Type 2 Diabetes: A Single-Centre Evaluation From a Community-Based Randomized Controlled Trial.

BACKGROUND: A recent randomized controlled trial demonstrated that a community-based, telephone-delivered diabetes health coaching intervention was effective for improving diabetes management. Our aim in this study was to determine whether this intervention is also cost-effective. METHODS: An economic evaluation, in the form of a cost-utility analysis (CUA), was used to assess the cost-effectiveness of the coaching intervention from a public payer's perspective. All direct medical costs, as well as intervention implementation, were included. The outcome measure for the CUA was quality-adjusted life-year (QALY). Uncertainty of cost-effectiveness results was estimated using nonparametric bootstraps of patient-level costs and QALYs in the coaching and control arms. A cost-effectiveness acceptability curve was used to express this uncertainty as the probability that diabetes health coaching is cost-effective across a range of values of willingness-to-pay thresholds for a QALY. RESULTS: The results show that subjects in the coaching arm incurred higher overall costs (in Canadian dollars) than subjects in the control arm ($1,581 vs $1,086, respectively) and incurred 0.02 more QALYs. The incremental cost-effectiveness ratio of the diabetes health coaching intervention compared with usual care was found to be $35,129 per QALY, with probabilities of 67% and 82% that diabetes health coaching would be cost-effective at a willingness-to-pay threshold of $50,000 per QALY and $100,000 per QALY, respectively. CONCLUSION: A community-based, telephone-delivered diabetes health coaching intervention is cost-effective.

Unilateral and bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression: a meta-analysis of randomized controlled trials over 2 decades

Background: Approximately 35% of people with depression do not respond to 2 courses of antidepressant medications of adequate dosage, and treatment-resistant depression (TRD) is still a major clinical concern with a great impact on patients, their families, society and the health system. The present meta-analysis evaluates antidepressant efficacy of unilateral and bilateral repetitive transcranial magnetic stimulation (rTMS) in patients with unipolar TRD. Methods: We searched for randomized controlled trials that compared rTMS with sham treatment and were published by Apr. 3, 2017. The primary outcome was improvement in depression scores measured using the Hamilton Rating Scale for Depression. The secondary outcomes were remission and response rates. Two independent review authors screened the studies and extracted the data. Results: Twenty-three studies met the inclusion criteria. Meta-analysis of the depression scores showed a weighted mean difference (WMD) of 3.36 (95% confidence interval [CI] 1.85­4.88) between unilateral rTMS and sham treatment. Stratified data showed that the effect was relatively higher when rTMS was used as an add-on to antidepressant medications (WMD 3.64, 95% CI 1.52­5.76) than when it was used as a stand-alone treatment (WMD 2.47, 95% CI 0.90­4.05). The WMD between bilateral rTMS and sham was 2.67 (95% CI 0.83­4.51), and all studies that contributed to this outcome used rTMS while participants were taking antidepressant medications. The pooled remission and response rates for unilateral rTMS versus sham treatment were 16.0% and 25.1% for rTMS and 5.7% and 11.0% for sham treatment, respectively. The pooled remission and response rates for bilateral rTMS versus sham treatment were 16.6% and 25.4% for rTMS and 2.0% and 6.8% for sham treatment, respectively. Conclusion: This study suggests that rTMS has moderate antidepressant effects and appears to be promising in the short-term treatment of patients with unipolar TRD.

Economic analysis of pharmacist-administered influenza vaccines in Ontario, Canada.

OBJECTIVE: The aim of this study was to evaluate the impact of pharmacist administration of influenza vaccine in Ontario on: 1) vaccination-associated costs related to the number of people vaccinated; 2) annual influenza-related outcomes and costs; and 3) change in productivity costs. METHODS: Using available data for Ontario, the total number of vaccinations given by providers in the 2011/12 influenza season (pre) was compared to the 2013/14 influenza season (post). Vaccine costs and provider fees for administration were assigned for both periods. An economic model was created to estimate the impact of the change in influenza vaccination volume on influenza-related outcomes and on the health care costs associated with treating influenza-related outcomes. Productivity costs due to both time off work due to getting vaccinated and influenza illness were considered. One-way sensitivity analysis was used to assess parameter uncertainty. RESULTS: The number of vaccinations received by Ontarians increased by 448,000 (3% of the population), with pharmacists vaccinating approximately 765,000 people/year. The increased cost to the Ontario Ministry of Health and Long-term Care was $6.3 million, while the money saved due to reduced influenza-related outcome costs was $763,158. Productivity losses were reduced by $4.5 million and $3.4 million for the time invested to get vaccinated and time off work due to influenza illness, respectively. CONCLUSION: After two influenza seasons, following the introduction of pharmacist-administered influenza vaccinations, there was a net immunization increase of almost 450,000, which potentially saved $2.3 million in direct health care costs and lost productivity in the province.

Direct Health-Care Costs and Productivity Costs Associated With Hypoglycemia in Adults With Type 1 and Type 2 Diabetes Mellitus That Participated in the Canadian Hypoglycemia Assessment Tool Program.

OBJECTIVES: There is a paucity of information concerning the cost of hypoglycemia events in Canadians with type 1 or type 2 diabetes. The objective of this study was to estimate the direct health-care costs and indirect costs associated with hypoglycemia based on a Canadian cohort of 498 patients from the global Hypoglycemia Assessment Tool (HAT) study. METHODS: A costing model was developed to estimate the direct costs related to experiencing hypoglycemia by using health-care resources associated with hospital admissions and additional clinical appointments that were prospectively reported 1 month after baseline in the HAT study. Data collected retrospectively on work absenteeism in the year prior to baseline were used to estimate the indirect costs of hypoglycemia events. All costs were annualized and reported in 2016 Canadian dollars. RESULTS: Of the 403 patients with diabetes who experienced hypoglycemia events in the first month after baseline (81%), 10 (2.5%) patients required hospitalization or clinical appointments. Over 1 year, the mean direct health-care costs were estimated to be C$90,300 (C$1,777 per patient) for hospitalizations and C$14,695 (C$204 per person) for additional clinical appointments. Work absenteeism resulted in a total annual indirect cost of C$20,937 for time off due to sick leave (C$500 per patient), arriving late (C$187 per patient) or leaving work early (C$128 per patient). The annual direct and indirect costs of hypoglycemia events total C$125,932. CONCLUSIONS: The impact of hypoglycemia events on health-care resource utilization and work productivity leads to substantial direct and indirect costs in Canadian patients with diabetes.

Preliminary Results of the Adoption and Application of the Integrated Comprehensive Care Bundle Care Program When Treating Patients with Chronic Obstructive Pulmonary Disease.

BACKGROUND: St. Joseph's Health System has implemented an integrated comprehensive care bundle care (ICC) program with the hopes that it would improve patients' care while reducing overall costs. The aim of this analysis was to evaluate the performance of the ICC program within patients admitted with chronic pulmonary obstructive disease (COPD). METHODS: We conducted a retrospective observational cohort study comparing ICC patients to non-ICC patients admitted to St. Joseph's Healthcare Hamilton for COPD being discharged with support services between June 2012 and March 2015, using administrative data. Confounding adjustment was achieved through the use of propensity score matching. Medical resource utilizations during the initial hospitalization and within the 60 days following discharge were compared using regression models. RESULTS: All 76 patients who entered the ICC program (100.0%) were matched 1 : 1 to 76 eligible non-ICC patients (28.4%). Length of stay (6.47 [7.29] versus 9.55 [10.21] days) and resource intensity weights (1.16 [0.80] versus 1.64 [1.69]) were lower in the ICC group within the initial hospitalization but, while favoring the ICC program, healthcare resource use tended not to differ statistically following discharge. INTERPRETATION: The ICC program was able to reduce initial medical resource utilization without increasing subsequent medical resource use.

Relationship between hyperbaric oxygen therapy and quality of life in participants with chronic diabetic foot ulcers: data from a randomized controlled trial.

AIMS: To investigate the effect of hyperbaric oxygen therapy on health-related quality of life (HRQoL) in participants with diabetes and chronic foot ulcers. METHODS: Using data from a randomized controlled trial, we included 103 participants (49 in hyperbaric oxygen therapy group and 54 in sham group) for analyses. The primary outcome was HRQoL as measured by the EQ-5D-3L instrument, while secondary outcomes included quality of life evaluated by the Short Form 36 (SF-36) and Diabetic Foot Ulcers Scale-Short Form (DFS-SF). We used the analysis of covariance to assess whether the EQ-5D index values in hyperbaric oxygen therapy group differed from the sham group. Logistic regression was used to assess the relationship between hyperbaric oxygen therapy and the responses of 'problems' for the EQ-5D health states. RESULTS: No significant differences in EQ-5D index values were found between the hyperbaric oxygen therapy and sham groups: 0.01 (95% CI -0.25, 0.28; p = 0.93) at week 12; 0.07 (95% CI -0.21, 0.34; p = 0.64) at week 6. Hyperbaric oxygen therapy was found to be associated with fewer participants reporting 'problems' in mobility (OR 0.24, 95% CI 0.07, 0.85 at week 12) and pain or discomfort (OR 0.20, 95% CI 0.07, 0.61 at week 6; OR 0.32, 95% CI 0.11, 0.97 at week 12), compared with the sham group. No significant differences in SF-36 or DFS-SF were observed. CONCLUSIONS: No significant effect of hyperbaric oxygen therapy on HRQoL measured by EQ-5D index value was found in this study. Due to the potential insufficient power to assess statistical difference, more large-scale research is needed to further evaluate the effect of hyperbaric oxygen therapy on HRQoL in participants with chronic diabetic foot ulcers.

Illustration of the Impact of Unmeasured Confounding Within an Economic Evaluation Based on Nonrandomized Data.

Background: Propensity score (PS) methods are frequently used within economic evaluations based on nonrandomized data to adjust for measured confounders, but many researchers omit the fact that they cannot adjust for unmeasured confounders. Objective: To illustrate how confounding due to unmeasured confounders can bias an economic evaluation despite PS matching. Methods: We used data from a previously published nonrandomized study to select a prematched population consisting of 121 patients (46.5%) who received endovascular aneurysm repair (EVAR) and 139 patients (53.5%) who received open surgical repair (OSR), in which sufficient data regarding eight measured confounders were available. One-to-one PS matching was used within this population to select two PS-matched subpopulations. The Matched PS-Smoking Excluded Subpopulation was selected by matching patients using a PS model that omitted patients' smoking status (one of the measured confounders), whereas the Matched PS-Smoking Included Subpopulation was selected by matching patients using a PS model that included all eight measured confounders. Incremental cost-effectiveness ratios (ICERs) were assessed within both subpopulations. Results: Both subpopulations were composed of two different sets of 164 patients. Balance within the Matched PS-Smoking Excluded Subpopulation was achieved on all confounders except for patients' smoking status, whereas balance within the Matched PS-Smoking Included Subpopulation was achieved on all confounders. Results indicated that the ICER of EVAR over OSR differed between both subpopulations; the ICER was estimated at $157,909 per life-year gained (LYG) within the Matched PS-Smoking Excluded Subpopulation, while it was estimated at $235,074 per LYG within the Matched PS-Smoking Included Subpopulation. Discussion: Although effective in controlling for measured confounding, PS matching may not adjust for unmeasured confounders that may bias the results of an economic evaluation based on nonrandomized data.

Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial.

OBJECTIVE: Hyperbaric oxygen therapy (HBOT) is used for the treatment of chronic diabetic foot ulcers (DFUs). The controlled evidence for the efficacy of this treatment is limited. The goal of this study was to assess the efficacy of HBOT in reducing the need for major amputation and improving wound healing in patients with diabetes and chronic DFUs. RESEARCH DESIGN AND METHODS: Patients with diabetes and foot lesions (Wagner grade 2-4) of at least 4 weeks' duration participated in this study. In addition to comprehensive wound care, participants were randomly assigned to receive 30 daily sessions of 90 min of HBOT (breathing oxygen at 244 kPa) or sham (breathing air at 125 kPa). Patients, physicians, and researchers were blinded to group assignment. At 12 weeks postrandomization, the primary outcome was freedom from meeting the criteria for amputation as assessed by a vascular surgeon. Secondary outcomes were measures of wound healing. RESULTS: One hundred fifty-seven patients were assessed for eligibility, with 107 randomly assigned and 103 available for end point adjudication. Criteria for major amputation were met in 13 of 54 patients in the sham group and 11 of 49 in the HBOT group (odds ratio 0.91 [95% CI 0.37, 2.28], P = 0.846). Twelve (22%) patients in the sham group and 10 (20%) in the HBOT group were healed (0.90 [0.35, 2.31], P = 0.823). All other indices of wound healing were also not statistically significantly different between groups. CONCLUSIONS: HBOT does not offer an additional advantage to comprehensive wound care in reducing the indication for amputation or facilitating wound healing in patients with chronic DFUs.

Pulmonary Rehabilitation in Ontario: A Cross-Sectional Survey.

BACKGROUND: Pulmonary rehabilitation (PR) is a comprehensive intervention of exercise training, education, and behaviour change to improve the physical and psychological condition of people with chronic respiratory disorders, such as chronic obstructive pulmonary disease (COPD) and to promote long-term adherence to health-enhancing behaviours. Although PR is considered the standard of care for patients with COPD who remain symptomatic despite bronchodilator therapies, current evidence suggests that only 1.15% of COPD patients across Canada have access to PR facilities for care. OBJECTIVES: The objectives of this study were to identify the number of health care facilities across Ontario providing PR services for patients with COPD, describe the scope of those services, and determine the province's current capacity to provide PR services relative to need, for the province as a whole and by local health integration network (LHIN). METHODS: The Pulmonary Rehabilitation Programs in Ontario (PRO) Survey was a province-wide, descriptive, cross-sectional survey of health care facilities (hospitals, family health teams, and community health centres). It was distributed to 409 facilities to collect information on various aspects of PR services in the province. RESULTS: Between April 2013 and February 2014, 187 facilities responded to the survey (46% response rate). Most responding centres (144) did not offer PR services, and only 43 were full PR sites providing a comprehensive program. Hospital-based programs made up the majority of sites offering full PR services (67%), followed by programs based at family health teams (19%) and community health centres (14%). More than 90% of PR programs are outpatient-based. The average wait time for outpatient PR was 6.9 weeks, and 58% of programs provide services 5 days per week. More than 80% of patients attending PR complete the full program. Across all program types, the total estimated provincial capacity for PR outpatient care is 4,524 patients per year, or 0.66% to 1.78% of patients with COPD, depending on the estimated prevalence of disease. LIMITATIONS: These results are representative of 12 of the 14 LHINs in Ontario due to low response rates in facilities in 2 LHINs. CONCLUSIONS: Although some increase in capacity has occurred since a similar survey in 2005, PR resources in Ontario are insufficient to support the delivery of care to people with COPD in accordance with clinical practice guideline recommendations.

A prospective trial of GreenLight PVP (HPS120) versus transurethral resection of the prostate in the treatment of lower urinary tract symptoms in Ontario, Canada.

BACKGROUND: Photoselective vaporization of the prostate (PVP) is a bloodless, relatively painless alternative to transurethral resection of the prostate (TURP) for relief of lower urinary tract symptoms (LUTS) in benign prostatic hyperplasia (BPH). OBJECTIVE: We compare the effectiveness, safety and cost-effectiveness of Greenlight Laser PVP (HPS-120) and TURP. METHODS: We conducted a prospective, non-randomized trial in 3 Ontario centres from March 2008 to February 2011. Assessments were completed at baseline, 1 and 6 months following surgery at the physicians' offices and at 12 and 24 months by phone. The primary outcome was the change in International Prostate Symptoms Score (IPSS) score at 6 months versus baseline. Secondary outcomes were changes in flow rate, postvoid residual (PVR), prostate-specific antigen (PSA) and sexual health inventory for men (SHIM) scores. Adverse events, health-related quality of life (HRQoL), resource utilization and productivity losses were collected. RESULTS: Although the IPSS decreased in both arms (n = 140 for PVP and n = 24 for TURP) between baseline and 6 months, the difference in change over time between the groups was not statistically significant (p = 0.718). Other outcomes improved equally from baseline and 6 months (Qmax, SHIM, PSA and HRQoL), with only changes in PVR favouring PVP (p = 0.018). There were no statistical differences in serious adverse events. In total, 130 of 140 PVP patients were outpatients, all TURP subjects were inpatients. PVP was less costly than TURP ($3891 vs. $4863; p < 0.001) with similar quality-adjusted life years (0.448 vs. 0.441; p = 0.658). CONCLUSION: Greenlight Laser PVP (HPS-120) is a safe and cost-effective alternative to TURP for outpatient treatment of LUTS and can be completed as an outpatient with minimal blood loss.

Photoselective vaporization for the treatment of benign prostatic hyperplasia.

BACKGROUND: As an alternative to transurethral resection of the prostate (TURP), photoselective vaporization of the prostate (PVP) provides a bloodless, relatively painless relief of lower urinary tract symptoms for men with benign prostatic hyperplasia. Following a review of the evidence in 2006, the Ontario Health Technology Advisory Committee recommended that a study be conducted to evaluate PVP in Ontario. OBJECTIVES: To compare the clinical effectiveness, safety, cost-effectiveness, and budget impact of PVP compared to conventional TURP for the treatment of benign prostatic hyperplasia in Ontario. METHODS: A prospective, nonrandomized trial was conducted in 3 Ontario centres. Consenting subjects were assessed at baseline and 1, 3, and 6 months following surgery. Outcome measures included International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), post-void residual (PVR) volume, prostate-specific antigen (PSA), health-related quality of life (HRQOL) using the EuroQol 5 Domain questionnaire, and the Sexual Health Inventory for Men (SHIM) score. Adverse events, resource utilization, and productivity losses were also assessed. Cost-effectiveness and budget impact analyses were completed using data from the study. RESULTS: Between February 2008 and August 2010, 164 subjects were enrolled in the study (n = 140 for PVP and n = 24 for TURP). Treatment outcomes were similar between the 2 groups at 6 months, with the IPSS decreasing similarly over time (P = 0.718). For other treatment outcomes (Qmax, PSA, HRQOL, SHIM) both treatments provided similar benefit over time; only changes in PVR volume favoured PVP (P = 0.018). The majority of PVP patients were managed on an outpatient basis, with only 7.1% requiring admission (all TURP subjects were inpatients). At 6 months, PVP was less costly than TURP ($3,891 versus $4,863; P = 0.001), with similar quality-adjusted life-years (0.448 versus 0.441; P = 0.658). PVP remained the most cost-effective treatment across all decision-making thresholds, with the technology costing less and providing similar clinical outcomes. Extrapolating the results to a provincial level indicated (based on an estimated case volume of 12,335 TURPs) that there is an opportunity to reallocate just over $14 million (Cdn), primarily related to the reduced need for hospital admission. LIMITATIONS: This study was nonrandomized, and the results should be interpreted with some caution, despite generally similar baseline characteristics between the 2 groups. Recruiting individuals to the TURP arm was a challenge, resulting in a size imbalance between treatment arms. CONCLUSIONS: Based on this analysis, PVP appears to be a cost-effective alternative to TURP, providing similar clinical benefit at a lower cost to the health system.

The burden of atrial fibrillation on the hospital sector in Canada.

BACKGROUND: Atrial fibrillation (AF) is a common disease that frequently requires acute hospital care; however, the cost of hospital care in Canada has not been reported. The purpose of this study was to estimate the cost of AF related to hospital-based care in Canada. METHODS: Analyses were conducted with 2 national administrative databases for the fiscal year 2007-2008. Databases included information for hospital admissions, day operations, and ambulatory care. Records with a most responsible diagnosis of AF, atrial flutter, or a diagnosis related to AF with a concomitant comorbidity of AF were included. Hospital costs were estimated, in 2010 Canadian dollars, by applying an average cost per weighted case to the resource intensity weight for each admission or visit and then adding the separate billable fee for admissions, surgical procedures, and interventions. RESULTS: In 2007-2008, the number of acute care admissions with AF as the most responsible diagnosis was 22,823, same-day surgical procedures was 5707, and emergency department visits was 58,066. The hospital costs attributable to AF were $815 million in 2010 Canadian dollars: $710 million for hospitalizations; $32 million for same-day surgical procedures; and $73 million for emergency department visits. Most of the acute care costs were for hospitalizations when AF was listed as a comorbidity ($558 million, or 69%). CONCLUSION: AF results in a substantial cost burden to the acute care hospital sector. Current hospital costs in AF patients are driven by the consequences of AF, while the costs for specific treatments for AF are relatively low.

The excess burden of rheumatoid arthritis in Ontario, Canada.

OBJECTIVES: The purpose of this study was to estimate the excess burden of RA in Ontario, the largest province in Canada. METHODS: The records of all adult Ontarians who participated in the Canadian Community Health Survey (CCHS) cycle 1.1 (2000/2001) and provided consent to data linkage were linked to the Ontario Health Insurance Program (OHIP) physician claims database and the Discharge Abstract Database (DAD) In-Patient (i.e. hospitalisation) and Day-Procedure databases. RA individuals (n=233) were identified using CCHS 1.1 and the physician claims database. A control group matched by age, gender and rural/urban status was created with three controls for one case (n=699). Socio-demographic variables, medical characteristics, health-related quality of life (HRQoL) and one-year physician services, hospitalizations and day procedures costs were determined for the RA and non-RA groups. Regression techniques were used to identify predictors of medical characteristics, utility and cost data. RESULTS: The mean age of the population was 59 years and 76% were female. Compared to the matched control group, individuals with RA were statistically more likely to be obese, less educated, physically inactive and have a lower income. RA individuals also reported a statistically higher number of comorbidities and a lower HRQoL. Although no statistical differences were observed between the RA and non-RA groups for the costs associated with hospitalisations, the physician ($1,015 vs. $624, respectively) and day procedure ($102 vs. $51, respectively) costs were statistically higher among RA individuals. CONCLUSIONS: These results indicate that the human and economic burden of RA in Ontario is considerable.

The excess burden of osteoarthritis in the province of Ontario, Canada.

OBJECTIVE: Little is known about the burden of osteoarthritis (OA) in Canada. This study was undertaken to estimate the excess burden of OA in Ontario, the largest province in Canada. METHODS: The records of Ontarian respondents to the Canadian Community Health Survey (CCHS) who provided consent to data linkage were linked to the Ontario Health Insurance Program physician claims database and the Discharge Abstract Database Inpatient and Day Procedure databases. Patients with OA (n = 1,474) were identified using CCHS 1.1 and the physician claims database. To determine the excess burden of OA, a control group matched by age, sex, and rural/urban status was created, with 3 controls per case (n = 4,422). Sociodemographic and medical characteristics, health-related quality of life, and 1-year physician, day (outpatient) procedure, and hospitalization costs were compared between the 2 groups. Regression analyses were performed to identify predictors of medical characteristics, health utility, and cost. RESULTS: The mean age of the OA patients and the control subjects was 66 years, and 74% of all study subjects were women. Several differences were observed between patients with OA and subjects without OA in terms of socioeconomic and medical characteristics. On a scale of 0-1, the mean utility value associated with OA was 0.68, compared to 0.84 for the control group (P < 0.0001), representing a utility decrement of 0.16. The 1-year physician, outpatient procedure, and hospitalization costs were significantly higher in the OA group than in the non-OA group ($2,233 Canadian versus $1,033 Canadian, respectively; P < 0.0001). CONCLUSION: These results indicate that the excess burden of OA in Ontario is considerable.

Ontario multidetector computed tomographic coronary angiography study: field evaluation of diagnostic accuracy.

BACKGROUND: Computed tomographic coronary angiography (CTCA) has gained clinical acceptance for the detection of obstructive coronary artery disease. Although single-center studies have demonstrated excellent accuracy, multicenter studies have yielded variable results. The true diagnostic accuracy of CTCA in the "real world" remains uncertain. We conducted a field evaluation comparing multidetector CTCA with invasive CA (ICA) to understand CTCA's diagnostic accuracy in a real-world setting. METHODS: A multicenter cohort study of patients awaiting ICA was conducted between September 2006 and June 2009. All patients had either a low or an intermediate pretest probability for coronary artery disease and underwent CTCA and ICA within 10 days. The results of CTCA and ICA were interpreted visually by local expert observers who were blinded to all clinical data and imaging results. RESULTS: Using a patient-based analysis (diameter stenosis ≥50%) of 169 patients, the sensitivity, specificity, positive predictive value, and negative predictive value were 81.3% (95% confidence interval [CI], 71.0%-89.1%), 93.3% (95% CI, 85.9%-97.5%), 91.6% (95% CI, 82.5%-96.8%), and 84.7% (95% CI, 76.0%-91.2%), respectively; the area under receiver operating characteristic curve was 0.873. The diagnostic accuracy varied across centers (P < .001), with a sensitivity, specificity, positive predictive value, and negative predictive value ranging from 50.0% to 93.2%, 92.0% to 100%, 84.6% to 100%, and 42.9% to 94.7%, respectively. CONCLUSIONS: Compared with ICA, CTCA appears to have good accuracy; however, there was variability in diagnostic accuracy across centers. Factors affecting institutional variability need to be better understood before CTCA is universally adopted. Additional real-world evaluations are needed to fully understand the impact of CTCA on clinical care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00371891.

Estimation of the impact of diabetes-related complications on health utilities for patients with type 2 diabetes in Ontario, Canada.

OBJECTIVES: The goal of this study was to analyze health-related quality of life (HRQL) data from a Canadian population with type 2 diabetes in order to estimate the disutility associated with experiencing a diabetes-related complication. METHODS: The EQ-5D, a standardized instrument for use as a measure of health outcome, was administered to 1,147 patients in Hamilton, Ontario, with type 2 diabetes. After controlling for age, gender, and duration of diabetes, changes in utility values were estimated by regressing the EQ-5D scores onto binary indicators for the presence of an event. The primary method of analysis was Ordinary Least Squares (OLS) and due to concerns over non-Normality, bootstrap standard errors (SE) were calculated. RESULTS: The analysis included 1,143 participants. Based on the OLS model, reductions in HRQL were associated with duration of diabetes (-0.0015, SE = 0.0006), experiencing a myocardial infarction (MI) (-0.059, SE = 0.017), amputation (-0.063, SE = 0.059), stroke (-0.046, SE = 0.023), and kidney failure (-0.102, SE = 0.047). CONCLUSION: This study estimated the reductions in HRQL associated with several important complications commonly experienced in patients with diabetes. The greatest impacts on HRQL were associated with kidney failure and MI. The utility values calculated here can be used to assess the outcome of interventions that reduce these diabetes-related complications and will have a useful impact on future economic evaluations of diabetes management strategies in Canada.

Evaluation of health outcomes in osteoarthritis patients after total knee replacement: a two-year follow-up.

OBJECTIVES: To quantify the improvement in health outcomes in patients after total knee replacement (TKR). METHODS: This was a two-year non-randomized prospective observational study in knee osteoarthritis (OA) patients undergone TKR. Patients were interviewed one week before, six months after, and two years after surgery using a standardized questionnaire including the SF-36, the Oxford Knee Score (OKS), and the Knee Society Clinical Rating Scale (KSS). A generalized estimating equation (GEE) model was used to estimate the magnitudes of the changes with and without the adjustment of age, ethnicity, BMI, and years with OA. RESULTS: A total of 298 (at baseline), 176 (at six-months), and 111 (at two-years) eligible patients were included in the analyses. All the scores changed significantly over time, with the exception of SF-36 social functioning, vitality, and mental health. With the adjustment of covariates, the magnitude of changes in these scores was similar to those without the adjustment. CONCLUSIONS: Both general and knee-specific physical functioning had been significantly improved after TKR, while other health domains have not been substantially improved after the surgery.

The unintended (and costly) effects due to the introduction of an unrestricted reimbursement policy for atypical antipsychotic medications in a Canadian public prescription drug program: 1996/97 to 2005/06.

BACKGROUND: Due to the increasing costs of pharmaceuticals, drug benefit programs often implement various policies that limit availability of drugs. These policies can have unforeseen consequences. OBJECTIVES: To examine the utilization and expenditures for antipsychotic medications in a provincial government community-based drug program over a 10-year period when atypical antipsychotics were introduced and multiple reimbursement policy changes with respect to these agents were employed. METHODS: Retrospective analysis of the Newfoundland and Labrador Prescription Drug Program (NLPDP) claims database from 1996/97 to 2005/06. Antipsychotic medication utilization and expenditure were measured and effects of changes in reimbursement policies examined. Excess expenditure was measured by subtracting the actual from modelled expenditure under different policies. RESULTS: Between 1996/97 and 2005/06, the number of prescriptions for antipsychotic medications increased by 75% and expenditures by more than 720% to $7.2 million (peaking at $7.9 million in 2003/04), with atypical agents making up 96% of the total. Expenditure for antipsychotic medications grew by an annual average rate of 26.3%. At the same time, the number of people enrolled in the drug program declined by an annual average rate of 1.13%. The total excess amount of money spent was $266,195 per 1,000 beneficiaries during unlimited access to atypical agents. CONCLUSION: There has been a substantial, unintentional, increase in the prescribing of atypical antipsychotics each year in Newfoundland and Labrador over the 10 years, likely due to off-label use following the unrestricted and partial restrictive access policies for these medications. Perhaps restricted access for recognized usage should be enforced.