Assessment of a venous thromboembolism prophylaxis shared decision-making intervention (DASH-TOP) using the decisional conflict scale: a mixed-method study.

BACKGROUND: Venous thromboembolism (VTE) in pregnancy is a major cause of maternal morbidity and death. The use of low-molecular-weight heparin (LMWH), despite being the standard of care to prevent VTE, comes with some challenges. Shared decision-making (SDM) interventions are recommended to support patients and clinicians in making preference-sensitive decisions. The quality of the SDM process has been widely assessed with the decisional conflict scale (DCS). Our aim is to report participants' perspectives of each of the components of an SDM intervention (DASH-TOP) in relation to the different subscales of the DCS. METHODS: Design: A convergent, parallel, mixed-methods design. PARTICIPANTS: The sample consisted of 22 health care professionals, students of an Applied Clinical Research in Health Sciences (ICACS) master program. INTERVENTION: We randomly divided the participants in three groups: Group 1 received one component (evidence -based information), Group 2 received two components (first component and value elicitation exercises), and Group 3 received all three components (the first two and a decision analysis recommendation) of the SDM intervention. ANALYSIS: For the quantitative strand, we used a non-parametric test to analyze the differences in the DCS subscales between the three groups. For the qualitative strand, we conducted a content analysis using the decisional conflict domains to deductively categorize the responses. RESULTS: Groups that received more intervention components experienced less conflict and better decision-making quality, although the differences between groups were not statistically significant. The decision analysis recommendation improved the efficacy with the decision-making process, however there are some challenges when implementing it in clinical practice. The uncertainty subscale showed a high decisional conflict for all three groups; contributing factors included low certainty of the evidence-based information provided and a perceived small effect of the drug to reduce the risk of a VTE event. CONCLUSIONS: The DASH-TOP intervention reduced decisional conflict in the decision -making process, with decision analysis being the most effective component to improve the quality of the decision. There is a need for more implementation research to improve the delivery of SDM interventions in the clinical encounter.

Anticoagulant Therapy for Cancer-Associated Thrombosis : A Cost-Effectiveness Analysis.

BACKGROUND: Direct oral anticoagulants (DOACs) offer an alternative to low-molecular-weight heparin (LMWH) and warfarin for treating cancer-associated thrombosis (CAT). OBJECTIVE: To determine the cost and effectiveness of DOACs versus LMWH. DESIGN: Cohort-state transition decision analytic model. DATA SOURCES: Network meta-analysis comparing DOACs versus LMWH. TARGET POPULATION: Adult patients with cancer at the time they develop thrombosis. TIME HORIZON: Lifetime. PERSPECTIVE: Health care sector. INTERVENTION: Strategies of 1) enoxaparin, 2) apixaban, 3) edoxaban, and 4) rivaroxaban for treatment of CAT. OUTCOME MEASURES: Incremental cost-effectiveness ratio (ICER) in 2022 U.S. dollars per quality-adjusted life-year (QALY) gained. RESULTS OF BASE-CASE ANALYSIS: In the base-case scenario, using drug prices from the U.S. Department of Veterans Affairs Federal Supply Schedule, apixaban dominated enoxaparin and edoxaban by being less costly and more effective. Rivaroxaban was slightly more effective than apixaban, with an ICER of $493 246. In a scenario analysis using "real-world" drug prices from GoodRx, rivaroxaban was cost-effective with an ICER of $50 053 per QALY. RESULTS OF SENSITIVITY ANALYSIS: Results were highly sensitive to monthly drug costs. Probabilistic sensitivity analyses showed that at a willingness-to-pay threshold of $50 000 per QALY, apixaban was preferred in 80% of simulations. However, sensitivity analyses also demonstrated that apixaban only remained cost-effective if monthly medication costs were below $530. Above this, rivaroxaban became cost-effective. LIMITATIONS: An assumption was made that patients would continue anticoagulation indefinitely unless they suffered a major bleed. Nonmedical costs such as patient and caregiver loss of productivity were not accounted for, and long-term thrombotic complications were not explicitly modeled. CONCLUSION: The 3 DOACs are more effective and more cost-effective than LMWH. The most cost-effective DOAC depends on the relative cost of each of these agents. These are important considerations for treating physicians and health policymakers. PRIMARY FUNDING SOURCE: None.

Should asymptomatic patients with congenital lung malformations undergo surgery? A decision analysis.

BACKGROUND: Congenital lung malformations (CLMs) are being detected more frequently during pregnancy. There is controversy regarding the optimal treatment for an asymptomatic child with prenatally diagnosed CLMs. Due to the paucity of information from clinical trials, we developed decision analytic models to compare two treatment strategies for such patients-elective surgical resection versus expectant management. METHODS: We built decision analytic models stratified by lesion size. We used data from English language literature identified through PubMed searches along with estimates from expert opinions of surgical colleagues. We analyzed results for two hypothetical asymptomatic 6-month-old children with CLMs; one has a large lesion occupying more than 50% of the involved lobe, while the other has a small lesion occupying less than 50% of the involved lobe. We used quality-adjusted life years (QALYs) to measure effectiveness. RESULTS: For an asymptomatic child with a small or large lesion, expectant management resulted in a small gain of 0.09 or 0.15 QALYs, respectively. Sensitivity analyses showed that surgical resection would be preferred if the probability of remaining asymptomatic was low. CONCLUSIONS: In contrast to current practice, expectant management may be a better alternative for asymptomatic children born with CLMs. More longitudinal studies are required to improve the accuracy of the model.

Implementing a Health Utility Assessment Platform to Acquire Health Utilities in a Hemodialysis Outpatient Setting: Feasibility Study.

BACKGROUND: Patients with end-stage kidney disease (ESKD) wait roughly 4 years for a kidney transplant. A potential way to reduce wait times is using hepatitis C virus (HCV)-viremic kidneys. OBJECTIVE: As preparation for developing a shared decision-making tool to assist patients with ESKD with the decision to accept an HCV-viremic kidney transplant, our initial goal was to assess the feasibility of using The Gambler II, a health utility assessment tool, in an ambulatory dialysis clinic setting. Our secondary goals were to collect health utilities for patients with ESKD and to explore whether the use of race-matched versus race-mismatched exemplars impacted the knowledge gained during the assessment process. METHODS: We used The Gambler II to elicit utilities for the following ESKD-related health states: hemodialysis, kidney transplant with HCV-unexposed kidney, and transplantation with HCV-viremic kidney. We created race exemplar video clips describing these health states and randomly assigned patients into the race-matched or race-mismatched video arms. We obtained utilities for these 3 health states from each patient, and we evaluated knowledge about ESKD and HCV-associated health conditions with pre- and postintervention knowledge assessments. RESULTS: A total of 63 patients with hemodialysis from 4 outpatient Dialysis Center Inc sites completed the study. Mean adjusted standard gamble utilities for hemodialysis, transplant with HCV-unexposed kidney, and transplantation with HCV-viremic kidney were 82.5, 89, and 75.5, respectively. General group knowledge assessment scores improved by 10 points (P<.05) following utility assessment process. The use of race-matched exemplars had little effect on the results of the knowledge assessment of patients. CONCLUSIONS: Using The Gambler II to collect utilities for patients with ESKD in an ambulatory dialysis clinic setting proved feasible. In addition, educational information about health states provided as part of the utility assessment process tool improved patients' knowledge and understanding about ESKD-related health states and implications of organ transplantation with HCV-viremic kidneys. A wide variation in patient health state utilities reinforces the importance of incorporating patients' preferences into decisions regarding use of HCV-viremic kidneys for transplantation.

A Cost-effectiveness Analysis of Adherence Promotion Strategies to Improve Rejection Rates in Adolescent Kidney Transplant Recipients.

RATIONALE & OBJECTIVE: Nonadherence to medical regimens increases the risk of graft loss among adolescent and young adult recipients of kidney transplants. Interventions that improve adherence may decrease rejection rates, but their perceived costs are a barrier to clinical implementation. We developed a model to assess the cost-effectiveness of an adherence promotion strategy, the Medication Adherence Promotion System (MAPS). STUDY DESIGN: Simulation-based. Data sources included published articles indexed in Medline or referenced in bibliographies of relevant English-language articles. Data on costs and outcomes were taken from a single clinical center. SETTING & POPULATION: US adolescent patients after their first kidney transplant. INTERVENTION: Usual posttransplant care versus usual care plus MAPS. OUTCOME: Effectiveness measured in quality-adjusted life years (QALYs) and costs measured in 2020 US dollars. MODEL, PERSPECTIVE, & TIMEFRAME: Markov state transition decision model. We used a health care system perspective with a lifelong time horizon. RESULTS: In the base-case analysis, MAPS was more effective and less costly than usual care. MAPS cost $9,106 per patient less than usual care and resulted in a gain of 0.32 QALYs. In probabilistic sensitivity analyses, MAPS was cost saving 100% of the time. Extending results to a program level with 100 patients, any adherence promotion intervention similar in effectiveness to MAPS would cost less than $50,000/QALY if the start-up costs were <$2.5 million and annual costs <$188,000. Strategies with costs similar to MAPS that reduce the risk of rejection by as little as 3% would also have similar cost-effectiveness. LIMITATIONS: Estimates of components and costs for MAPS were based on a single center. CONCLUSIONS: Adherence promotion strategies with costs similar to MAPS can be cost-effective as long as they reduce rejection rates by at least 3%. This model can be applied to study the cost-effectiveness of adherence promotion strategies with varying costs and outcomes.

More work needed on decision analysis for shared decision-making: A scoping review.

OBJECTIVE: To explore and characterize published evidence on the ways decision analysis has been used to inform shared decision-making. STUDY DESIGN AND SETTING: For this scoping review, we searched five bibliographic databases (from inception until February 2021), reference lists of included studies, trial registries, a thesis database and websites of relevant interest groups. Studies were eligible if they evaluated the application of decision analysis in a shared decision-making encounter. Pairs of reviewers independently screened and selected studies for inclusion, extracted study information using a data extraction form developed by the research team and assessed risk of bias for all studies with an experimental or quasi-experimental design. Data were narratively synthesized. RESULTS: We identified 27 studies that varied greatly with regard to their patient population, design, content and delivery. A range of outcomes were evaluated to explore the effectiveness and acceptability of decision analytic interventions, with little information about the implementation process. Most studies found that decision analysis was broadly beneficial. CONCLUSION: Despite the compelling rationale on the potential for decision analysis to support shared decision-making, rigorous randomized controlled trials are needed to confirm these interventions' effectiveness, while qualitative studies should seek to understand their potential implementation.

Racial and sex differences in optimizing anticoagulation therapy for patients with atrial fibrillation.

Study objective: Atrial fibrillation (AF) is the most common cardiac rhythm disorder, responsible for 15 % of strokes in the United States. Studies continue to document underuse of anticoagulation therapy in minority populations and women. Our objective was to compare the proportion of AF patients by race and sex who were receiving non-optimal anticoagulation as determined by an Atrial Fibrillation Decision Support Tool (AFDST). Design setting and participants: Retrospective cohort study including 14,942 patients within University of Cincinnati Health Care system. Data were analyzed between November 18, 2020, and November 20, 2021. Main outcomes and measures: Discordance between current therapy and that recommended by the AFDST. Results: In our two-category analysis 6107 (41 %) received non-optimal anticoagulation therapy, defined as current treatment category ≠ AFDST-recommended treatment category. Non-optimal therapy was highest in Black (42 % [n = 712]) and women (42 % [n = 2668]) and lower in White (39 % [n = 4748]) and male (40 % [n = 3439]) patients. Compared with White patients, unadjusted and adjusted odds ratios of receiving non-optimal anticoagulant therapy for Black patients were 1.13; 95 % CI, 1.02-1.30, p = 0.02; and 1.17; 95%CI, 1.04-1.31, p = 0.01; respectively, and 1.10; 95 % CI 1.03-1.18, p = 0.005; and 1.36; 95 % CI, 1.25-1.47, p < 0.001; for females compared with males. Conclusions and relevance: In patients with atrial fibrillation in the University of Cincinnati Health system, Black race and female sex were independently associated with an increased odds of receiving non-optimal anticoagulant therapy.

Cost-Effectiveness of Utilization of Hepatitis B Virus-Positive Liver Donors for HBV-Negative Transplant Recipients.

BACKGROUND: Utilization of hepatitis B virus (HBV)-infected donors represents an opportunity to expand the liver transplantation (LT) donor pool. However, benefits of accepting HBV-positive donors for HBV-negative candidates, potentially expanding the donor pool resulting in earlier transplantation, must be balanced with costs of lifelong antiviral therapy. The aim of this study was to evaluate cost-effectiveness of this strategy. METHODS: We developed a Markov model with two strategies, transplant with (1) a HBV-positive donor versus and (2) a HBV-negative donor for a HBV-negative LT candidate. A healthcare system perspective was utilized, effectiveness measured in quality-adjusted life-years, and costs in 2018 USD. RESULTS: In the base-case, the HBV-positive donor strategy is more effective (gain of 0.46 QALYs), but $26,159 more expensive, yielding an incremental cost-effectiveness ratio (ICER) of $57,389/QALY. However, increasing the candidate's Model for End-Stage Liver Disease score resulted in increasing cost-effectiveness, ICER of $69,507/QALY (MELD 6-10) to $47,385/QALY (MELD > 30). Results were most sensitive to antiviral cost and cost after first year of LT. In probabilistic sensitivity analysis, the HBV-positive strategy was always more effective but more expensive, with average ICER of $64,883/QALY. This strategy was highly cost-effective (ICER < $50,000/QALY) 21% of the time and cost < $100/000/QALY 94% of the time. CONCLUSIONS: Consideration of these donors must be individualized to each candidate's severity of liver disease, associated costs, and personal preferences that impact quality of life. Expansion of the donor pool to include HBV-positive donors for appropriate recipients may be a cost-effective policy and may provide significant benefit for individual patients.

Cost-effectiveness of Sexually Transmitted Infection Screening for Adolescents and Young Adults in the Pediatric Emergency Department.

Importance: Adolescents and young adults compose almost 50% of all diagnosed sexually transmitted infection (STI) cases annually in the US. Given that these individuals frequently access health care through the emergency department (ED), the ED could be a strategic venue for examining the identification and treatment of STIs. Objective: To examine the cost-effectiveness of screening strategies for Chlamydia trachomatis and Neisseria gonorrhoeae (chlamydia and gonorrhea) in adolescents and young adults who seek acute care at pediatric EDs. Design, Setting, and Participants: This economic evaluation is a component of an ongoing, larger multicenter clinical trial at the Pediatric Emergency Care Applied Research Network. A decision analytic model, created using literature-based estimates for the key parameters, was developed to simulate the events and outcomes associated with 3 strategies for screening and testing chlamydial and gonococcal infections in individuals aged 15 to 21 years who sought acute care at pediatric EDs. Data sources included published (from January 1, 1997, to December 31, 2019) English-language articles indexed in MEDLINE, bibliographies in relevant articles, insurance claims data in the MarketScan database, and reimbursement payments from the Centers for Medicare and Medicaid Services. Because the events and outcomes were simulated, a hypothetical population of 10 000 ED visits by adolescents and young adults was used. Interventions: The 3 screening strategies were (1) no screening, (2) targeted screening, and (3) universally offered screening. Targeted screening involved the completion of a sexual health survey, which yielded an estimated STI risk (at risk, high risk, or low risk). Main Outcomes and Measures: Outcome metrics included cost (measured in 2019 US dollars) and the detection and successful treatment of STIs. The incremental cost-effectiveness ratio (ICER) of each strategy was calculated in a base case analysis. The ICER reflects the cost per case detected and successfully treated. Results: A 3.6% prevalence of chlamydia and gonorrhea was applied to a hypothetical population of 10 000 ED visits by adolescents and young adults. Targeted screening resulted in the detection and successful treatment of 95 of 360 STI cases (26.4%) at a cost of $313 063, and universally offered screening identified and treated 112 of 360 STI cases (31.1%) at a cost of $515 503. The ICER for targeted screening vs no screening was $6444, and the ICER for universally offered screening vs targeted screening was $12 139. Conclusions and Relevance: This economic evaluation found that targeted screening and universally offered screening compared with no screening appeared to be cost-effective strategies for identifying and treating chlamydial and gonococcal infections in adolescents and young adults who used the ED for acute care. Universally offered screening was associated with detecting and successfully treating a higher proportion of STIs in this population.

Sugammadex versus neostigmine for routine reversal of rocuronium block in adult patients: A cost analysis.

STUDY OBJECTIVE: This report analyzes the comparative costs, efficacy and side effects of a newer, more expensive reversal drug, sugammadex, with its generic counterpart, neostigmine combined with glycopyrrolate, or no reversal agent when used routinely to reverse rocuronium-induced neuromuscular blockade in adult patients. DESIGN: Cost analysis. METHODS: We constructed a decision model to analyze the costs associated with the choice of reversal drug and differences in reversal time, occurrence of postoperative nausea or vomiting (PONV), and residual blockade requiring unplanned postoperative mechanical ventilation (UPMV). We selected variables that demonstrated meaningful differences in meta-analyses of published studies and/or had significant associated costs. We used data from local hospital system information, meta-analysis of published studies, and the general literature to construct base-case scenarios and sensitivity analyses. We performed the analysis from the perspective of a single hospital system. Costs were in 2019 U.S. dollars. RESULTS: Cost analysis suggested that reversal with sugammadex is preferable to neostigmine or no reversal drug when operating room (OR) time was valued at ≥$8.60/min (base case $32.49/min). Net costs of sugammadex were less than no treatment or neostigmine reversal when the probability of UPMV exceeded 0.019 and 0.036, respectively. Neither sugammadex nor neostigmine reversal was preferable to no treatment in a base-case analysis that considered the effect of the reversal agent on only drug and PONV costs, disregarding costs of OR time or UPMV. CONCLUSIONS: Routine reversal with sugammadex is preferable to choosing neostigmine or no reversal drug when accounting for potential savings in OR time. Sugammadex might also be a reasonable choice for patients at high risk of UPMV. If the cost of OR time is not considered, the analysis does not support the routine use of sugammadex in patients with perceived increased risk or solely to reduce PONV.

Cost-effectiveness of Using Kidneys From HCV-Viremic Donors for Transplantation Into HCV-Uninfected Recipients.

RATIONALE & OBJECTIVE: Less than 4% of patients with kidney failure receive kidney transplants. Although discard rates of hepatitis C virus (HCV)-viremic kidneys are declining, ~39% of HCV-viremic kidneys donated between 2018 and 2019 were discarded. Highly effective antiviral agents are now available to treat chronic HCV infection. Thus, our objective was to examine the cost-effectiveness of transplanting kidneys from HCV-viremic donors into HCV-uninfected recipients. STUDY DESIGN: Markov state transition decision model. Data sources include Medline search results, bibliographies from relevant English language articles, Scientific Registry of Transplant Recipients, and the US Renal Data System. SETTING & POPULATION: US patients receiving maintenance hemodialysis who are on kidney transplant waiting lists. INTERVENTION(S): Transplantation with an HCV-unexposed kidney versus transplantation with an HCV-viremic kidney and HCV treatment. OUTCOMES: Effectiveness measured in quality-adjusted life-years and costs measured in 2018 US dollars. MODEL, PERSPECTIVE, AND TIMEFRAME: We used a health care system perspective with a lifelong time horizon. RESULTS: In the base-case analysis, transplantation with an HCV-viremic kidney was more effective and less costly than transplantation with an HCV-unexposed kidney because of the longer waiting times for HCV-unexposed kidneys, the substantial excess mortality risk while receiving dialysis, and the high efficacy of direct-acting antiviral agents for HCV infection. Transplantation with an HCV-viremic kidney was also preferred in sensitivity analyses of multiple model parameters. The strategy remained cost-effective unless waiting list time for an HCV-viremic kidney exceeded 3.1 years compared with the base-case value of 1.56 year. LIMITATIONS: Estimates of waiting times for patients willing to accept an HCV-viremic kidney were based on data for patients who received HCV-viremic kidney transplants. CONCLUSIONS: Transplanting kidneys from HCV-viremic donors into HCV-uninfected recipients increased quality-adjusted life expectancy and reduced costs compared with a strategy of transplanting kidneys from HCV-unexposed donors.

Cervical spine evaluation in pediatric trauma: A cost-effectiveness analysis.

OBJECTIVE: The emergent evaluation of children with suspected traumatic cervical spine injuries (CSI) remains a challenge. Pediatric clinical pathways have been developed to stratify the risk of CSI and guide computed tomography (CT) utilization. The cost-effectiveness of their application has not been evaluated. Our objective was to examine the cost-effectiveness of three common strategies for the evaluation of children with suspected CSI after blunt injury. METHODS: We developed a decision analytic model comparing these strategies to estimate clinical outcomes and costs for a hypothetical population of 0-17 year old patients with blunt neck trauma. Strategies included: 1) clinical pathway to stratify risk using NEXUS criteria and determine need for diagnostic testing; 2) screening radiographs as a first diagnostic; and 3) immediate CT scanning for all patients. We measured effectiveness with quality-adjusted life years (QALYs), and costs with 2018 U.S. dollars. Costs and effectiveness were discounted at 3% per year. RESULTS: The use of the clinical pathway results in a gain of 0.04 QALYs and a cost saving of $2800 compared with immediate CT scanning of all patients. Use of the clinical pathway was less costly and more effective than immediate CT scan as long as the sensitivity of the clinical prediction rule was greater than 87% and when the sensitivity of x-ray was greater than 84%. CONCLUSION: A strategy using a clinical pathway to first stratify risk before further diagnostic testing was less costly and more effective than either performing CT scanning or screening cervical radiographs on all patients.

Cost Effectiveness of Universal Screening for Hepatitis C Virus Infection in the Era of Direct-Acting, Pangenotypic Treatment Regimens.

BACKGROUND & AIMS: Most persons infected with hepatitis C virus (HCV) in the United States were born from 1945 through 1965; testing is recommended for this cohort. However, HCV incidence is increasing among younger persons in many parts of the country and treatment is recommended for all adults with HCV infection. We aimed to estimate the cost effectiveness of universal 1-time screening for HCV infection in all adults living in the United States and to determine the prevalence of HCV antibody above which HCV testing is cost effective. METHODS: We developed a Markov state transition model to estimate the effects of universal 1-time screening of adults 18 years or older in the United States, compared with the current guideline-based strategy of screening adults born from 1945 through 1965. We compared potential outcomes of 1-time universal screening of adults or birth cohort screening followed by antiviral treatment of those with HCV infection vs no screening. We measured effectiveness with quality-adjusted life-years (QALY), and costs with 2017 US dollars. RESULTS: Based on our model, universal 1-time screening of US residents with a general population prevalence of HCV antibody greater than 0.07% cost less than $50,000/QALY compared with a strategy of no screening. Compared with 1-time birth cohort screening, universal 1-time screening and treatment cost $11,378/QALY gained. Universal screening was cost effective compared with birth cohort screening when the prevalence of HCV antibody positivity was greater than 0.07% among adults not in the cohort born from 1945 through 1965. CONCLUSIONS: Using a Markov state transition model, we found a strategy of universal 1-time screening for chronic HCV infection to be cost effective compared with either no screening or birth cohort-based screening alone.

Anticoagulation in pulmonary arterial hypertension: a decision analysis.

Systemic anticoagulation may be beneficial in pulmonary arterial hypertension, but there is no randomized clinical trial data to guide therapeutic decision making, and current guidelines do not account for patient preferences or quality of life. Decision analytic models to evaluate the potential risks and benefits of systemic anticoagulation in pulmonary arterial hypertension patients, focusing on the benefit in quality-adjusted life years, may be helpful in clarifying this uncertainty. We constructed a 31-state Markov decision analytic model to explore anticoagulation and no anticoagulation strategies. Modeled patient characteristics included gender, use of central catheter-based pulmonary arterial hypertension therapy, type of pulmonary arterial hypertension (idiopathic, idiopathic pulmonary arterial hypertension, or connective-tissue associated, connective tissue disease-pulmonary arterial hypertension), and use of oral contraceptive medication by females. Modeled events included mortality, thromboembolic complications, atrial fibrillation, stroke, and anticoagulation bleeding. Deterministic and probabilistic sensitivity analyses were performed. Anticoagulation was favored in all idiopathic pulmonary arterial hypertension cases, with a gain of 0.43-0.51 quality-adjusted life years, and detrimental in all connective tissue disease-pulmonary arterial hypertension cases, with a loss of 0.66-1.89 quality-adjusted life years. Anticoagulation would need to demonstrate a hazard ratio for pulmonary arterial hypertension mortality of 0.95 or better to be favored. In our model, idiopathic pulmonary arterial hypertension patients benefit from anticoagulation in terms of quality-adjusted life years, and connective tissue disease-pulmonary arterial hypertension patients were harmed, with a hazard ratio for pulmonary arterial hypertension mortality of 0.95 or better being required to favorably impact quality-adjusted life years. These results suggest that anticoagulation significantly improves quality adjusted life years and should be offered to all idiopathic pulmonary arterial hypertension patients. Shared decision models based on these results may help clarify therapeutic decision-making uncertainty in pulmonary arterial hypertension patients.

Effect of Variation in Published Stroke Rates on the Net Clinical Benefit of Anticoagulation for Atrial Fibrillation.

Background: Stroke rates in patients with nonvalvular atrial fibrillation (AF) who are not receiving anticoagulant therapy vary widely across published studies; the resulting effect on the net clinical benefit of anticoagulation in AF is unknown. Objective: To determine the effect of variation in published AF stroke rates on the net clinical benefit of anticoagulation. Design: Markov model decision analysis. Warfarin was the base case, and non-vitamin K antagonist oral anticoagulants (NOACs) were modeled in a secondary analysis. Setting: Community-dwelling adults. Patients: 33 434 adults with incident AF. Measurements: Quality-adjusted life-years (QALYs). Results: Of the 33 434 patients, 27 179 had a CHA2DS2-VASc (congestive heart failure, hypertension, age, diabetes, stroke, and vascular disease) score of 2 or more. The population benefit of warfarin anticoagulation for these patients was least using stroke rates from the ATRIA (AnTicoagulation and Risk Factors In Atrial Fibrillation) study and greatest using those from the Danish National Patient Registry (6290 QALYs [95% CI, ±2.3%] vs. 24 110 QALYs [CI, ±1.9%]; P < 0.001). The optimal CHA2DS2-VASc score threshold for anticoagulation was 3 or more using stroke rates from ATRIA, 2 or more using those from the Swedish AF cohort study, 1 or more using those from the SPORTIF (Stroke Prevention using ORal Thrombin Inhibitor in atrial Fibrillation) study, and 0 or more using those from the Danish National Patient Registry. Accounting for lower rates of NOAC-associated intracranial hemorrhage decreased optimal CHA2DS2-VASc score thresholds, but these thresholds still varied widely. Limitation: Measured benefit may not generalize to other populations. Conclusion: Variation in published AF stroke rates for patients not receiving anticoagulant therapy results in multifold variation in the net clinical benefit of anticoagulation. Guidelines should better reflect the uncertainty in current thresholds of stroke risk score for recommending anticoagulation. Primary Funding Source: None.

Transplanting Hepatitis C Virus-Infected Versus Uninfected Kidneys Into Hepatitis C Virus-Infected Recipients: A Cost-Effectiveness Analysis.

Background: Direct-acting antiviral agents are now available to treat chronic hepatitis C virus (HCV) infection in patients with end-stage renal disease (ESRD). Objective: To examine whether it is more cost-effective to transplant HCV-infected or HCV-uninfected kidneys into HCV-infected patients. Design: Markov state-transition decision model. Data Sources: MEDLINE searches and bibliographies from relevant English-language articles. Target Population: HCV-infected patients with ESRD receiving hemodialysis in the United States. Time Horizon: Lifetime. Perspective: Health care system. Intervention: Transplant of an HCV-infected kidney followed by HCV treatment versus transplant of an HCV-uninfected kidney preceded by HCV treatment. Outcome Measures: Effectiveness, measured in quality-adjusted life-years (QALYs), and costs, measured in 2017 U.S. dollars. Results of Base-Case Analysis: Transplant of an HCV-infected kidney followed by HCV treatment was more effective and less costly than transplant of an HCV-uninfected kidney preceded by HCV treatment, largely because of longer wait times for uninfected kidneys. A typical 57.8-year-old patient receiving hemodialysis would gain an average of 0.50 QALY at a lifetime cost savings of $41 591. Results of Sensitivity Analysis: Transplant of an HCV-infected kidney followed by HCV treatment continued to be preferred in sensitivity analyses of many model parameters. Transplant of an HCV-uninfected kidney preceded by HCV treatment was not preferred unless the additional wait time for an uninfected kidney was less than 161 days. Limitation: The study did not consider the benefit of decreased HCV transmission from treating HCV-infected patients. Conclusion: Transplanting HCV-infected kidneys into HCV-infected patients increased quality-adjusted life expectancy and reduced costs compared with transplanting HCV-uninfected kidneys into HCV-infected patients. Primary Funding Source: Merck Sharp & Dohme and the National Center for Advancing Translational Sciences.

Cost-Effectiveness Analysis of an Adherence-Promotion Intervention for Children With Leukemia: A Markov Model-Based Simulation.

Objective: Improving medication adherence among children with B-cell precursor acute lymphoblastic leukemia (B-ALL) has the potential to reduce relapse rates but requires an investment in resources. An economic evaluation is needed to understand the potential costs and benefits of delivering adherence-promotion interventions (APIs) as part of standard clinical care. Methods: A Markov decision analytic model was used to simulate the potential incremental cost-effectiveness per quality-adjusted life year (QALY) to be gained from an API for children with B-ALL in first continuous remission compared with treatment as usual (TAU, no intervention). Model parameter estimates were informed by previously published studies. The primary outcome was incremental cost (2015 US$) per QALY gained for API compared with TAU. Results: The model predicts the API to result in superior health outcomes (4.87 vs. 4.86 QALYs) and cost savings ($43,540.73 vs. $46,675.71) as compared with TAU, and simulations indicate that, across a range of plausible parameter estimates, there is a 95% chance that the API is more effective and less costly than TAU. The API was estimated to remain more effective and less costly than TAU in situations where the prevalence of nonadherence exceeds 32% and when API improves baseline adherence in at least 3% of patients. Conclusions: Providing APIs to children with B-ALL may improve health outcomes and save costs over a 6-year period.

Prehospital Triage of Acute Ischemic Stroke Patients to an Intravenous tPA-Ready versus Endovascular-Ready Hospital: A Decision Analysis.

BACKGROUND: American Stroke Association guidelines for prehospital acute ischemic stroke recommend against bypassing an intravenous tPA-ready hospital (IRH), if additional transportation time to an endovascular-ready hospital (ERH) exceeds 15-20 min. However, it is unknown when the benefit of potential endovascular therapy at an ERH outweighs the harm from delaying intravenous therapy at a closer IRH, especially since large vessel occlusion (LVO) status is initially unknown. We hypothesized that current time recommendations for IRH bypass are too short to achieve optimal outcomes for certain patient populations. METHODS: A decision analysis model was constructed using population-based databases, a detailed literature review, and interventional trial data containing time-dependent modified Rankin Scale distributions. The base case was triaged by Emergency Medical Services (EMS) 110 min after stroke onset and had a 23.6% LVO rate. Base case triage choices were (1) transport to the closest IRH (12 min), (2) transport to the ERH (60 min) bypassing the IRH, or (3) apply the Cincinnati Stroke Triage Assessment Tool and transport to the ERH if positive for LVO. Outcomes were assessed using quality-adjusted life years (QALYs). Sensitivity analyses were performed for all major variables, and alternative prehospital stroke scales were assessed. RESULTS: In the base case, transport to the IRH was the optimal choice with an expected outcome of 8.47 QALYs. Sensitivity analyses demonstrated that transport to the ERH was superior until bypass time exceeded 44 additional minutes, or when the onset to EMS triage interval exceeded 99 min. As the probability of LVO increased, ERH transport was optimal at longer onset to EMS triage intervals. The optimal triage strategy was highly dependent on specific interactions between the IRH transportation time, ERH transportation time, and onset to EMS triage interval. CONCLUSIONS: No single time difference between IRH and ERH transportation optimizes triage for all patients. Allowable IRH bypass time should be increased and acute ischemic stroke guidelines should incorporate the onset to EMS triage interval, IRH transportation time, and ERH transportation time.

Cost-effectiveness of intravenous acetaminophen and ketorolac in adolescents undergoing idiopathic scoliosis surgery.

BACKGROUND: Enhanced recovery after surgery protocols increasingly use multimodal analgesia after major surgeries with intravenous acetaminophen and ketorolac, despite no documented cost-effectiveness of these strategies. AIMS: The goal of this prospective cohort study was to model cost-effectiveness of adding acetaminophen or acetaminophen + ketorolac to opioids for postoperative outcomes in children having scoliosis surgery. METHODS: Of 106 postsurgical children, 36 received only opioids, 26 received intravenous acetaminophen, and 44 received acetaminophen + ketorolac as analgesia adjuncts. Costs were calculated in 2015 US $. Decision analytic model was constructed with Decision Maker® software. Base-case and sensitivity analyses were performed with effectiveness defined as avoidance of opioid adverse effects. RESULTS: The groups were comparable demographically. Compared with opioids-only strategy, subjects in the intravenous acetaminophen + ketorolac strategy consumed less opioids (P = .002; difference in mean morphine consumption on postoperative days 1 and 2 was -0.44 mg/kg (95% CI -0.72 to -0.16); tolerated meals earlier (P < .001; RR 0.250 (0.112-0.556)) and had less constipation (P < .001; RR 0.226 (0.094-0.546)). Base-case analysis showed that of the 3 strategies, use of opioids alone is both most costly and least effective, opioids + intravenous acetaminophen is intermediate in both cost and effectiveness; and opioids + intravenous acetaminophen and ketorolac is the least expensive and most effective strategy. The addition of intravenous acetaminophen with or without ketorolac to an opioid-only strategy saves $510-$947 per patient undergoing spine surgery and decreases opioid side effects. CONCLUSION: Intravenous acetaminophen with or without ketorolac reduced opioid consumption, opioid-related adverse effects, length of stay, and thereby cost of care following idiopathic scoliosis in adolescents compared with opioids-alone postoperative analgesia strategy.