Clinical impact of disinvestment in hydroxyethyl starch for patients undergoing coronary artery bypass surgery: a retrospective observational study.

PURPOSE: To examine the effect of discontinuing hydroxyethyl starch (HES) solutions on length of hospital stay, transfusion, risk of death, acute kidney injury (AKI), and dialysis. METHODS: We conducted a historical cohort study of linked administrative and clinical databases in patients undergoing coronary artery bypass surgery (CABG) on cardiopulmonary bypass. We used propensity scores to match patients who did not receive HES (after discontinuation) with patients exposed to HES (before discontinuation) and also controlled for albumin exposure. Hospital length of stay (the primary outcome) was analyzed using Fine-Gray proportional hazard regression, with hospital discharge as the outcome and death as a competing risk. Adverse outcomes were compared between matched patients using conditional logistic regression. RESULTS: We compared 1,085 propensity score-matched pairs (n = 2,170) from a pool of 2,757 patients. Discontinuation of HES was associated with shorter length of hospital stay, as evidenced by an increased probability of discharge (hazard ratio, 1.24; 95% confidence interval [CI], 1.14 to 1.35) and a reduced risk of red blood cell transfusion (odds ratio [OR], 0.68; 95% CI, 0.55 to 0.84), plasma transfusion (OR, 0.48; 95% CI, 0.34 to 0.66), and platelet transfusion (OR, 0.62; 95% CI, 0.44 to 0.87). Discontinuation of HES was not associated with in-hospital mortality (OR, 0.74; 95% CI, 0.36 to 1.54), AKI (OR, 0.84; 95% CI, 0.57 to 1.25), or dialysis (OR, 0.83; 95% CI, 0.25 to 2.73). CONCLUSIONS: For patients undergoing CABG on cardiopulmonary bypass, discontinuation of HES was associated with reduced hospital length of stay and reduced blood product transfusion, without measurable change in renal failure, dialysis rate, or in-hospital mortality. Our results should be interpreted with caution, though we found no evidence of harms associated with discontinuing HES. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT02329158); registered 31 December, 2014.

Sustained responders have better quality of life and productivity compared with treatment failures long after antiviral therapy for hepatitis C.

OBJECTIVES: We sought to compare the health status of patients with a sustained response to antiviral therapy for hepatitis C virus (HCV) infection with that of treatment failures, using health-related quality of life and preference (utility) measures. METHODS: Sustained responders had undetectable HCV viral levels 6 months after antiviral therapy. After antiviral therapy, participants completed, by mail or interview, the hepatitis-specific Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36), the Health Utilities Index Mark 2/3 (HUI2/3), and time trade-off (TTO) for current health. The respondents provided information on demographics, history of substance abuse, comorbidities, and health history. Detailed clinical information was obtained by chart review. The respondents also indicated whether they missed work, volunteer opportunities, or household activities during the previous 3 months because of hepatitis C infection or its treatment. RESULTS: A total of 235 patients (133 responders and 102 treatment failures) completed questionnaires at an average of 3.7 years after the end of treatment. Treatment failures had significantly lower scores on the eight SF-36 domains (P<0.01), lower scores on the hepatitis-specific domains (P<0.0001), and lower physical (42.5 vs. 49.2) and mental (40.5 vs. 46.1) component summary scores (P<0.01). HUI3 (0.57 vs. 0.70), HUI2 (0.74 vs. 0.80), SF-6D (0.65 vs. 0.71), and TTO (0.84 vs. 0.89) were lower for treatment failures (P<0.05). The regression-adjusted difference in HUI3, SF-6D, physical summary score, and mental summary score was 0.08 (P=0.04), 0.05 (P=0.004), 5.22 (P=0.001), and 5.73 (P<0.0001), respectively. Differences in the HUI2 and TTO scores were not significant after adjustment for demographic and clinical variables. Treatment failures were more likely to have missed work, volunteer opportunities, or household activities in the previous 3 months because of hepatitis C infection or its treatment (44 vs. 9%, P<0.001). CONCLUSIONS: Patients with a sustained response to antiviral therapy for chronic HCV infection have better quality of life than treatment failures do. Our study validates the benefits associated with the sustained response to antiviral therapy in a real-world clinic population and shows that these benefits are maintained over the long term.

Healthcare utilization costs of emerging adults with mood and anxiety disorders in an early intervention treatment program compared to a matched cohort.

AIM: The First Episode Mood and Anxiety Disorder Program (FEMAP) provides treatment to emerging adults with mood and anxiety disorders in an accessible, youth-friendly environment. We sought to investigate FEMAP's impact on the costs of care. METHODS: We conducted a retrospective observational study of one-year health service costs using linked administrative datasets to compare emerging adults treated at FEMAP (FEMAP users) to propensity-score matched controls (non-users). Costs from the perspective of the Ontario Ministry of Health and Long-Term Care, included drug benefit claims, inpatient, physician and ambulatory care services. We used bootstrapping to perform unadjusted comparisons between FEMAP users and non-users, by cost category and overall. We performed risk-adjusted comparison of overall costs using generalized estimating equations. RESULTS: FEMAP users (n = 366) incurred significantly lower costs compared to non-users (n = 660), for inpatient services (-$784, 95% confidence interval [CI] -$1765, -$28), ambulatory care services (-$90, 95% CI -$175, -$14) and drug benefit claims (-$47, 95% CI -$115,-$4) and significantly higher physician services costs ($435, 95% CI $276, $581) over 1 year. The unadjusted difference in overall costs was not significant (-$853, 95% CI -$2048, $142). Following adjustment for age, sex and age at first mental health diagnosis, the difference of -$914 (95% CI (-$2747, $919)) was also not significant. CONCLUSIONS: FEMAP was associated with significantly lower costs of inpatient and ambulatory care services, and higher costs of physician services, however we are unable to conclude that FEMAP is cost-saving overall.

Antithrombotic treatment after coronary artery bypass graft surgery: systematic review and network meta-analysis.

OBJECTIVE: To assess the effects of different oral antithrombotic drugs that prevent saphenous vein graft failure in patients undergoing coronary artery bypass graft surgery. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Medline, Embase, Web of Science, CINAHL, and the Cochrane Library from inception to 25 January 2019. ELIGIBILITY CRITERIA: for selecting studies Randomised controlled trials of participants (aged ≥18) who received oral antithrombotic drugs (antiplatelets or anticoagulants) to prevent saphenous vein graft failure after coronary artery bypass graft surgery. MAIN OUTCOME MEASURES: The primary efficacy endpoint was saphenous vein graft failure and the primary safety endpoint was major bleeding. Secondary endpoints were myocardial infarction and death. RESULTS: This review identified 3266 citations, and 21 articles that related to 20 randomised controlled trials were included in the network meta-analysis. These 20 trials comprised 4803 participants and investigated nine different interventions (eight active and one placebo). Moderate certainty evidence supports the use of dual antiplatelet therapy with either aspirin plus ticagrelor (odds ratio 0.50, 95% confidence interval 0.31 to 0.79, number needed to treat 10) or aspirin plus clopidogrel (0.60, 0.42 to 0.86, 19) to reduce saphenous vein graft failure when compared with aspirin monotherapy. The study found no strong evidence of differences in major bleeding, myocardial infarction, and death among different antithrombotic therapies. The possibility of intransitivity could not be ruled out; however, between-trial heterogeneity and incoherence were low in all included analyses. Sensitivity analysis using per graft data did not change the effect estimates. CONCLUSIONS: The results of this network meta-analysis suggest an important absolute benefit of adding ticagrelor or clopidogrel to aspirin to prevent saphenous vein graft failure after coronary artery bypass graft surgery. Dual antiplatelet therapy after surgery should be tailored to the patient by balancing the safety and efficacy profile of the drug intervention against important patient outcomes. STUDY REGISTRATION: PROSPERO registration number CRD42017065678.

A systematic review and methodological evaluation of published cost-effectiveness analyses of aromatase inhibitors versus tamoxifen in early stage breast cancer.

BACKGROUND: A key priority in developing policies for providing affordable cancer care is measuring the value for money of new therapies using cost-effectiveness analyses (CEAs). For CEA to be useful it should focus on relevant outcomes and include thorough investigation of uncertainty. Randomized controlled trials (RCTs) of five years of aromatase inhibitors (AI) versus five years of tamoxifen in the treatment of post-menopausal women with early stage breast cancer, show benefit of AI in terms of disease free survival (DFS) but not overall survival (OS) and indicate higher risk of fracture with AI. Policy-relevant CEA of AI versus tamoxifen should focus on OS and include analysis of uncertainty over key assumptions. METHODS: We conducted a systematic review of published CEAs comparing an AI to tamoxifen. We searched Ovid MEDLINE, EMBASE, PsychINFO, and the Cochrane Database of Systematic Reviews without language restrictions. We selected CEAs with outcomes expressed as cost per life year or cost per quality adjusted life year (QALY). We assessed quality using the Neumann checklist. Using structured forms two abstractors collected descriptive information, sources of data, baseline assumptions on effectiveness and adverse events, and recorded approaches to assessing parameter uncertainty, methodological uncertainty, and structural uncertainty. RESULTS: We identified 1,622 citations and 18 studies met inclusion criteria. All CE estimates assumed a survival benefit for aromatase inhibitors. Twelve studies performed sensitivity analysis on the risk of adverse events and 7 assumed no additional mortality risk with any adverse event. Sub-group analysis was limited; 6 studies examined older women, 2 examined women with low recurrence risk, and 1 examined women with multiple comorbidities. CONCLUSION: Published CEAs comparing AIs to tamoxifen assumed an OS benefit though none has been shown in RCTs, leading to an overestimate of the cost-effectiveness of AIs. Results of these CEA analyses may be suboptimal for guiding policy.