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STUDY OBJECTIVES: Evaluate a triaged stepped-care strategy among adults 50 and older with insomnia disorder. METHODS: Participants (N=245) were classified at baseline by a Triage-Checklist. Those projected to do better if they start treatment with therapist versus digitally delivered CBT-I (tCBT-I versus dCBT-I) constituted the YES stratum (n=137); the rest constituted the NO stratum (n=108). Participants were randomized within stratum to a strategy that utilized only dCBT-I (ONLN) or to a strategy that prospectively allocated the first step of care to dCBT-I or tCBT-I based on the Triage-Checklist and switched dCBT-I non-responders at 2-months to tCBT-I (STEP). Co-primary outcomes were the insomnia severity index (ISI) and the average nightly amount of prescription hypnotic medications used (MEDS), assessed at 2,4,6,9, and 12 months post-randomization. RESULTS: Mixed effects models revealed that, compared to ONLN, participants in STEP had greater reductions in ISI (p=0.001; η2=0.01) and MEDS (p=0.019, η2=0.01). Within the YES stratum, compared to ONLN, those in STEP had greater reductions in ISI (p=0.0001, η2=0.023) and MEDS (p=0.018, η2=0.01). Within the ONLN arm, compared to the YES stratum, those in the NO stratum had greater reductions in ISI (p=0.015, η2=0.01) but not in MEDS. Results did not change with treatment-dose covariate adjustment. CONCLUSIONS: Triaged-stepped care can help guide allocation of limited CBT-I treatment resources to promote effective and safe treatment of chronic insomnia among middle age and older adults. Further refinement of the Triage-Checklist and optimization of the timing and switching criteria may improve the balance between effectiveness and use of resources.
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Background: Tuberculosis incidence is increasing in Latin America, where the incarcerated population has nearly quadrupled since 1990. The full impact of incarceration on the tuberculosis epidemic, accounting for effects beyond prisons, has never been quantified. Methods: We calibrated dynamic compartmental transmission models to historical and contemporary data from Argentina, Brazil, Colombia, El Salvador, Mexico, and Peru, which comprise approximately 80% of the region's incarcerated population and tuberculosis burden. Using historical counterfactual scenarios, we estimated the transmission population attributable fraction (tPAF) for incarceration and the excess population-level burden attributable to increasing incarceration prevalence since 1990. We additionally projected the impact of alternative incarceration policies on future population tuberculosis incidence. Findings: Population tuberculosis incidence in 2019 was 29.4% (95% UI, 23.9-36.8) higher than expected without the rise in incarceration since 1990, corresponding to 34,393 (95% UI, 28,295-42,579) excess incident cases across countries. The incarceration tPAF in 2019 was 27.2% (95% UI, 20.9-35.8), exceeding estimates for other risk factors like HIV, alcohol use disorder, and undernutrition. Compared to a scenario where incarceration rates remain stable at current levels, a gradual 50% reduction in prison admissions and duration of incarceration by 2034 would reduce population tuberculosis incidence by over 10% in all countries except Mexico. Interpretation: The historical rise in incarceration in Latin America has resulted in a large excess tuberculosis burden that has been under-recognized to-date. International health agencies, ministries of justice, and national tuberculosis programs should collaborate to address this health crisis with comprehensive strategies, including decarceration. Funding: National Institutes of Health.
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Importance: High emergency department (ED) pediatric readiness is associated with improved survival, but the impact of changes to ED readiness is unknown. Objective: To evaluate the association of changes in ED pediatric readiness at US trauma centers between 2013 and 2021 with pediatric mortality. Design, Setting, and Participants: This retrospective cohort study was performed from January 1, 2012, through December 31, 2021, at EDs of trauma centers in 48 states and the District of Columbia. Participants included injured children younger than 18 years with admission or injury-related death at a participating trauma center, including transfers to other trauma centers. Data analysis was performed from May 2023 to January 2024. Exposure: Change in ED pediatric readiness, measured using the weighted Pediatric Readiness Score (wPRS, range 0-100, with higher scores denoting greater readiness) from national assessments in 2013 and 2021. Change groups included high-high (wPRS ≥93 on both assessments), low-high (wPRS <93 in 2013 and wPRS ≥93 in 2021), high-low (wPRS ≥93 in 2013 and wPRS <93 in 2021), and low-low (wPRS <93 on both assessments). Main Outcomes and Measures: The primary outcome was lives saved vs lost, according to ED and in-hospital mortality. The risk-adjusted association between changes in ED readiness and mortality was evaluated using a hierarchical, mixed-effects logistic regression model based on a standardized risk-adjustment model for trauma, with a random slope-random intercept to account for clustering by the initial ED. Results: The primary sample included 467â¯932 children (300â¯024 boys [64.1%]; median [IQR] age, 10 [4 to 15] years; median [IQR] Injury Severity Score, 4 [4 to 15]) at 417 trauma centers. Observed mortality by ED readiness change group was 3838 deaths of 144â¯136 children (2.7%) in the low-low ED group, 1804 deaths of 103â¯767 children (1.7%) in the high-low ED group, 1288 deaths of 64â¯544 children (2.0%) in the low-high ED group, and 2614 deaths of 155â¯485 children (1.7%) in the high-high ED group. After risk adjustment, high-readiness EDs (persistent or change to) had 643 additional lives saved (95% CI, -328 to 1599 additional lives saved). Low-readiness EDs (persistent or change to) had 729 additional preventable deaths (95% CI, -373 to 1831 preventable deaths). Secondary analysis suggested that a threshold of wPRS 90 or higher may optimize the number of lives saved. Among 716 trauma centers that took both assessments, the median (IQR) wPRS decreased from 81 (63 to 94) in 2013 to 77 (64 to 93) in 2021 because of reductions in care coordination and quality improvement. Conclusions and Relevance: Although the findings of this study of injured children in US trauma centers were not statistically significant, they suggest that trauma centers should increase their level of ED pediatric readiness to reduce mortality and increase the number of pediatric lives saved after injury.
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Serviço Hospitalar de Emergência , Centros de Traumatologia , Humanos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Criança , Estudos Retrospectivos , Feminino , Masculino , Pré-Escolar , Centros de Traumatologia/estatística & dados numéricos , Adolescente , Estados Unidos/epidemiologia , Mortalidade Hospitalar/tendências , Ferimentos e Lesões/mortalidade , Lactente , Mortalidade da Criança/tendênciasRESUMO
Objectives. To determine facility-level factors associated with COVID-19 outbreaks in US Immigration and Customs Enforcement (ICE) detention centers. Methods. We obtained COVID-19 case counts at 88 ICE detention facilities from May 6, 2020, through June 21, 2021, from the COVID Prison Project. We obtained information about facility population size, facility type (dedicated to immigrants or mixed with other incarcerated populations), and facility operator (public vs private contractor) from third-party sources. We defined the threshold for a COVID-19 outbreak as a cumulative 3-week incidence of 10% or more of the detained population. Results. Sixty-three facilities (72%) had at least 1 outbreak. Facilities with any outbreak were significantly more likely to be privately operated (P < .001), to have larger populations (113 vs 37; P = .002), and to have greater changes in their population size over the study period (â56% vs -26%; P < .001). Conclusions. Several facility-level factors were associated with the occurrence of COVID-19 outbreaks in ICE facilities. Public Health Implications. Structural and organizational factors that promote respiratory infection spread in ICE facilities must be addressed to protect detainee health. (Am J Public Health. 2024;114(9):909-912. https://doi.org/10.2105/AJPH.2024.307704).
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COVID-19 , Humanos , COVID-19/epidemiologia , Estados Unidos/epidemiologia , Surtos de Doenças , Emigração e Imigração/legislação & jurisprudência , Emigração e Imigração/estatística & dados numéricos , SARS-CoV-2 , Prisões/estatística & dados numéricos , Prisões Locais/estatística & dados numéricosRESUMO
Objective: We estimate annual hospital expenditures to achieve high emergency department (ED) pediatric readiness (HPR), that is, weighted Pediatric Readiness Score (wPRS) ≥ 88 (0-100 scale) across EDs with different pediatric volumes of children, overall and after accounting for current levels of readiness. Methods: We calculated the annual hospital costs of HPR based on two components: (1) ED pediatric equipment and supplies and (2) labor costs required for a Pediatric Emergency Care Coordinator (PECC) to perform pediatric readiness tasks. Data sources to generate labor cost estimates included: 2021 national salary information from U.S. Bureau of Labor Statistics, detailed patient and readiness data from 983 EDs in 11 states, the 2021 National Pediatric Readiness Project assessment; a national PECC survey; and a regional PECC survey. Data sources for equipment and supply costs included: purchasing costs from seven healthcare organizations and equipment usage per ED pediatric volume. We excluded costs of day-to-day ED operations (ie, direct clinical care and routine ED supplies). Results: The total annual hospital costs for HPR ranged from $77,712 (95% CI 54,719-100,694) for low volume EDs to $279,134 (95% CI 196,487-362,179) for very high volume EDs; equipment costs accounted for 0.9-5.0% of expenses. The total annual cost-per-patient ranged from $3/child (95% CI 2-4/child) to $222/child (95% CI 156-288/child). After accounting for current readiness levels, the cost to reach HPR ranged from $23,775 among low volume EDs to $145,521 among high volume EDs, with costs per patient of $4/child to $48/child. Conclusions: Annual hospital costs for HPR are modest, particularly when considered per child.
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PURPOSE: Typhoid fever causes substantial morbidity and mortality in Bangladesh. The government of Bangladesh plans to introduce typhoid conjugate vaccines (TCV) in its expanded program on immunization (EPI) schedule. However, the optimal introduction strategy in addition to the costs and benefits of such a program are unclear. METHODS: We extended an existing mathematical model of typhoid transmission to integrate cost data, clinical incidence data, and recently conducted serosurveys in urban, semi-urban, and rural areas. In our primary analysis, we evaluated the status quo (i.e., no vaccination) and eight vaccine introduction strategies including routine and 1-time campaign strategies, which differed by age groups targeted and geographic focus. Model outcomes included clinical incidence, seroincidence, deaths, costs, disability-adjusted life years (DALYs), and incremental cost-effectiveness ratios (ICERs) for each strategy. We adopted a societal perspective, 10-year model time horizon, and 3 % annual discount rate. We performed probabilistic, one-way, and scenario sensitivity analyses including adopting a healthcare perspective and alternate model time horizons. RESULTS: We projected that all TCV strategies would be cost saving compared to the status quo. The preferred strategy was a nationwide introduction of TCV at 9-12 months of age with a single catch-up campaign for children ages 1-15, which was cost saving compared to all other strategies and the status quo. In the 10 years following implementation, we projected this strategy would avert 3.77 million cases (95 % CrI: 2.60 - 5.18), 11.31 thousand deaths (95 % CrI: 3.77 - 23.60), and save $172.35 million (95 % CrI: -14.29 - 460.59) compared to the status quo. Our findings were broadly robust to changes in parameter values and willingness-to-pay thresholds. CONCLUSIONS: We projected that nationwide TCV introduction with a catch-up campaign would substantially reduce typhoid incidence and very likely be cost saving in Bangladesh.
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Febre Tifoide , Vacinas Tíficas-Paratíficas , Criança , Humanos , Febre Tifoide/epidemiologia , Febre Tifoide/prevenção & controle , Análise Custo-Benefício , Vacinas Conjugadas , Saúde Pública , Bangladesh/epidemiologiaRESUMO
AIM: To assess the effectiveness and cost-effectiveness of buprenorphine and methadone treatment in the U.S. if exemptions expanding coverage for substance use disorder services via telehealth and allowing opioid treatment programs to supply a greater number of take-home doses of medications for opioid use disorder (OUD) continue (Notice of Proposed Rule Making, NPRM). DESIGN SETTING AND PARTICIPANTS: Model-based analysis of buprenorphine and methadone treatment for a cohort of 100,000 individuals with OUD, varying treatment retention and overdose risk among individuals receiving and not receiving methadone treatment compared to the status quo (no NPRM). INTERVENTION: Buprenorphine and methadone treatment under NPRM. MEASUREMENTS: Fatal and nonfatal overdoses and deaths over five years, discounted lifetime per person QALYs and costs. FINDINGS: For buprenorphine treatment under the status quo, 1.21 QALYs are gained at a cost of $19,200/QALY gained compared to no treatment; with 20% higher treatment retention, 1.28 QALYs are gained at a cost of $17,900/QALY gained compared to no treatment, and the strategy dominates the status quo. For methadone treatment under the status quo, 1.11 QALYs are gained at a cost of $17,900/QALY gained compared to no treatment. In all scenarios, methadone provision cost less than $20,000/QALY gained compared to no treatment, and less than $50,000/QALY gained compared to status quo methadone treatment. CONCLUSIONS: Buprenorphine and methadone OUD treatment under NPRM are likely to be effective and cost-effective. Increases in overdose risk with take-home methadone would reduce health benefits. Clinical and technological strategies could mitigate this risk.
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Buprenorfina , Overdose de Drogas , Transtornos Relacionados ao Uso de Opioides , Humanos , Análise Custo-Benefício , Overdose de Drogas/tratamento farmacológico , Buprenorfina/uso terapêutico , Metadona/uso terapêutico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológicoRESUMO
Objective. To compare resource utilization and costs associated with 3 alternative screening approaches to identify early-onset sepsis (EOS) in infants born at ≥35 wk of gestational age, as recommended by the American Academy of Pediatrics (AAP) in 2018. Study Design. Decision tree-based cost analysis of the 3 AAP-recommended approaches: 1) categorical risk assessment (categorization by chorioamnionitis exposure status), 2) neonatal sepsis calculator (a multivariate prediction model based on perinatal risk factors), and 3) enhanced clinical observation (assessment based on serial clinical examinations). We evaluated resource utilization and direct costs (2022 US dollars) to the health system. Results. Categorical risk assessment led to the greatest neonatal intensive care unit usage (210 d per 1,000 live births) and antibiotic exposure (6.8%) compared with the neonatal sepsis calculator (112 d per 1,000 live births and 3.6%) and enhanced clinical observation (99 d per 1,000 live births and 3.1%). While the per-live birth hospital costs of the 3 approaches were similar-categorical risk assessment cost $1,360, the neonatal sepsis calculator cost $1,317, and enhanced clinical observation cost $1,310-the cost of infants receiving intervention under categorical risk assessment was approximately twice that of the other 2 strategies. Results were robust to variations in data parameters. Conclusion. The neonatal sepsis calculator and enhanced clinical observation approaches may be preferred to categorical risk assessment as they reduce the number of infants receiving intervention and thus antibiotic exposure and associated costs. All 3 approaches have similar costs over all live births, and prior literature has indicated similar health outcomes. Inclusion of downstream effects of antibiotic exposure in the neonatal period should be evaluated within a cost-effectiveness analysis. Highlights: Of the 3 approaches recommended by the American Academy of Pediatrics in 2018 to identify early-onset sepsis in infants born at ≥35 weeks, the categorical risk assessment approach leads to about twice as many infants receiving evaluation to rule out early-onset sepsis compared with the neonatal sepsis calculator and enhanced clinical observation approaches.While the hospital costs of the 3 approaches were similar over the entire population of live births, the neonatal sepsis calculator and enhanced clinical observation approaches reduce antibiotic exposure, neonatal intensive care unit admission, and hospital costs associated with interventions as part of the screening approach compared with the categorical risk assessment approach.
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BACKGROUND: Compartmental infectious disease (ID) models are often used to evaluate nonpharmaceutical interventions (NPIs) and vaccines. Such models rarely separate within-household and community transmission, potentially introducing biases in situations in which multiple transmission routes exist. We formulated an approach that incorporates household structure into ID models, extending the work of House and Keeling. DESIGN: We developed a multicompartment susceptible-exposed-infectious-recovered-susceptible-vaccinated (MC-SEIRSV) modeling framework, allowing nonexponentially distributed duration in exposed and infectious compartments, that tracks within-household and community transmission. We simulated epidemics that varied by community and household transmission rates, waning immunity rate, household size (3 or 5 members), and numbers of exposed and infectious compartments (1-3 each). We calibrated otherwise identical models without household structure to the early phase of each parameter combination's epidemic curve. We compared each model pair in terms of epidemic forecasts and predicted NPI and vaccine impacts on the timing and magnitude of the epidemic peak and its total size. Meta-analytic regressions characterized the relationship between household structure inclusion and the size and direction of biases. RESULTS: Otherwise similar models with and without household structure produced equivalent early epidemic curves. However, forecasts from models without household structure were biased. Without intervention, they were upward biased on peak size and total epidemic size, with biases also depending on the number of exposed and infectious compartments. Model-estimated NPI effects of a 60% reduction in community contacts on peak time and size were systematically overestimated without household structure. Biases were smaller with a 20% reduction NPI. Because vaccination affected both community and household transmission, their biases were smaller. CONCLUSIONS: ID models without household structure can produce biased outcomes in settings in which within-household and community transmission differ. HIGHLIGHTS: Infectious disease models rarely separate household transmission from community transmission. The pace of household transmission may differ from community transmission, depends on household size, and can accelerate epidemic growth.Many infectious disease models assume exponential duration distributions for infected states. However, the duration of most infections is not exponentially distributed, and distributional choice alters modeled epidemic dynamics and intervention effectiveness.We propose a mathematical framework for household and community transmission that allows for nonexponential duration times and a suite of interventions and quantified the effect of accounting for household transmission by varying household size and duration distributions of infected states on modeled epidemic dynamics.Failure to include household structure induces biases in the modeled overall course of an epidemic and the effects of interventions delivered differentially in community settings. Epidemic dynamics are faster and more intense in populations with larger household sizes and for diseases with nonexponentially distributed infectious durations. Modelers should consider explicitly incorporating household structure to quantify the effects of non-pharmaceutical interventions (e.g., shelter-in-place).
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Doenças Transmissíveis , Epidemias , Humanos , Doenças Transmissíveis/epidemiologia , Epidemias/prevenção & controleRESUMO
BACKGROUND: The potential for selection bias in nonrepresentative, large-scale, low-cost survey data can limit their utility for population health measurement and public health decision making. We developed an approach to bias adjust county-level COVID-19 vaccination coverage predictions from the large-scale US COVID-19 Trends and Impact Survey. DESIGN: We developed a multistep regression framework to adjust for selection bias in predicted county-level vaccination coverage plateaus. Our approach included poststratification to the American Community Survey, adjusting for differences in observed covariates, and secondary normalization to an unbiased reference indicator. As a case study, we prospectively applied this framework to predict county-level long-run vaccination coverage among children ages 5 to 11 y. We evaluated our approach against an interim observed measure of 3-mo coverage for children ages 5 to 11 y and used long-term coverage estimates to monitor equity in the pace of vaccination scale up. RESULTS: Our predictions suggested a low ceiling on long-term national vaccination coverage (46%), detected substantial geographic heterogeneity (ranging from 11% to 91% across counties in the United States), and highlighted widespread disparities in the pace of scale up in the 3 mo following Emergency Use Authorization of COVID-19 vaccination for 5- to 11-y-olds. LIMITATIONS: We relied on historical relationships between vaccination hesitancy and observed coverage, which may not capture rapid changes in the COVID-19 policy and epidemiologic landscape. CONCLUSIONS: Our analysis demonstrates an approach to leverage differing strengths of multiple sources of information to produce estimates on the time scale and geographic scale necessary for proactive decision making. IMPLICATIONS: Designing integrated health measurement systems that combine sources with different advantages across the spectrum of timeliness, spatial resolution, and representativeness can maximize the benefits of data collection relative to costs. HIGHLIGHTS: The COVID-19 pandemic catalyzed massive survey data collection efforts that prioritized timeliness and sample size over population representativeness.The potential for selection bias in these large-scale, low-cost, nonrepresentative data has led to questions about their utility for population health measurement.We developed a multistep regression framework to bias adjust county-level vaccination coverage predictions from the largest public health survey conducted in the United States to date: the US COVID-19 Trends and Impact Survey.Our study demonstrates the value of leveraging differing strengths of multiple data sources to generate estimates on the time scale and geographic scale necessary for proactive public health decision making.
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COVID-19 , Cobertura Vacinal , Criança , Humanos , Estados Unidos/epidemiologia , Vacinas contra COVID-19/uso terapêutico , Pandemias , COVID-19/epidemiologia , COVID-19/prevenção & controle , Inquéritos e Questionários , VacinaçãoRESUMO
Importance: Presentation to emergency departments (EDs) with high levels of pediatric readiness is associated with improved pediatric survival. However, it is unclear whether children of all races and ethnicities benefit equitably from increased levels of such readiness. Objective: To evaluate the association of ED pediatric readiness with in-hospital mortality among children of different races and ethnicities with traumatic injuries or acute medical emergencies. Design, Setting, and Participants: This cohort study of children requiring emergency care in 586 EDs across 11 states was conducted from January 1, 2012, through December 31, 2017. Eligible participants included children younger than 18 years who were hospitalized for an acute medical emergency or traumatic injury. Data analysis was conducted between November 2022 and April 2023. Exposure: Hospitalization for acute medical emergency or traumatic injury. Main Outcomes and Measures: The primary outcome was in-hospital mortality. ED pediatric readiness was measured through the weighted Pediatric Readiness Score (wPRS) from the 2013 National Pediatric Readiness Project assessment and categorized by quartile. Multivariable, hierarchical, mixed-effects logistic regression was used to evaluate the association of race and ethnicity with in-hospital mortality. Results: The cohort included 633â¯536 children (median [IQR] age 4 [0-12] years]). There were 557â¯537 children (98â¯504 Black [17.7%], 167â¯838 Hispanic [30.1%], 311â¯157 White [55.8%], and 147â¯876 children of other races or ethnicities [26.5%]) who were hospitalized for acute medical emergencies, of whom 5158 (0.9%) died; 75â¯999 children (12â¯727 Black [16.7%], 21â¯604 Hispanic [28.4%], 44â¯203 White [58.2%]; and 21â¯609 of other races and ethnicities [27.7%]) were hospitalized for traumatic injuries, of whom 1339 (1.8%) died. Adjusted mortality of Black children with acute medical emergencies was significantly greater than that of Hispanic children, White children, and of children of other races and ethnicities (odds ratio [OR], 1.69; 95% CI, 1.59-1.79) across all quartile levels of ED pediatric readiness; but there were no racial or ethnic disparities in mortality when comparing Black children with traumatic injuries with Hispanic children, White children, and children of other races and ethnicities with traumatic injuries (OR 1.01; 95% CI, 0.89-1.15). When compared with hospitals in the lowest quartile of ED pediatric readiness, children who were treated at hospitals in the highest quartile had significantly lower mortality in both the acute medical emergency cohort (OR 0.24; 95% CI, 0.16-0.36) and traumatic injury cohort (OR, 0.39; 95% CI, 0.25-0.61). The greatest survival advantage associated with high pediatric readiness was experienced for Black children in the acute medical emergency cohort. Conclusions and Relevance: In this study, racial and ethnic disparities in mortality existed among children treated for acute medical emergencies but not traumatic injuries. Increased ED pediatric readiness was associated with reduced disparities; it was estimated that increasing the ED pediatric readiness levels of hospitals in the 3 lowest quartiles would result in an estimated 3-fold reduction in disparity for pediatric mortality. However, increased pediatric readiness did not eliminate disparities, indicating that organizations and initiatives dedicated to increasing ED pediatric readiness should consider formal integration of health equity into efforts to improve pediatric emergency care.
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Mortalidade da Criança , Serviço Hospitalar de Emergência , Etnicidade , Mortalidade Hospitalar , Criança , Pré-Escolar , Humanos , Lactente , Recém-Nascido , Estudos de Coortes , Emergências , Serviço Hospitalar de Emergência/estatística & dados numéricos , Hispânico ou Latino , Negro ou Afro-Americano , Grupos RaciaisRESUMO
BACKGROUND: Economic evaluations of treatments increasingly employ price-threshold analyses. When a treatment has multiple indications, standard price-threshold analyses can be overly simplistic. We examine how rules governing indication-specific prices and reimbursement decisions affect value-based price analyses. METHODS: We analyze a 2-stage game between 2 players: the therapy's manufacturer and the payer purchasing it for patients. First, the manufacturer selects a price(s) that may be indication specific. Then, the payer decides whether to provide reimbursement at the offered price(s). We assume known indication-specific demand. The manufacturer seeks to maximize profit. The payer seeks to maximize total population incremental net monetary benefit and will not pay more than their willingness-to-pay threshold. We consider game variants defined by constraints on the manufacturer's ability to price and payer's ability to provide reimbursement differentially by indication. RESULTS: When both the manufacturer and payer can make indication-specific decisions, the problem simplifies to multiple single-indication price-threshold analyses, and the manufacturer captures all the consumer surplus. When the manufacturer is restricted to one price and the payer must make an all-or-nothing reimbursement decision, the selected price is a weighted average of indication-specific threshold prices such that reimbursement of more valuable indications subsidizes reimbursement of less valuable indications. With a single price and indication-specific coverage decisions, the manufacturer may select a high price where fewer patients receive treatment because the payer restricts reimbursement to the set of indications providing value commensurate with the high price. However, the manufacturer may select a low price, resulting in reimbursement for more indications and positive consumer surplus. CONCLUSIONS: When treatments have multiple indications, economic evaluations including price-threshold analyses should carefully consider jurisdiction-specific rules regarding pricing and reimbursement decisions. HIGHLIGHTS: With treatment prices rising, economic evaluations increasingly employ price-threshold analyses to identify value-based prices. Standard price-threshold analyses can be overly simplistic when treatments have multiple indications.Jurisdiction-specific rules governing indication-specific prices and reimbursement decisions affect value-based price analyses.When the manufacturer is restricted to one price for all indications and the payer must make an all-or-nothing reimbursement decision, the selected price is a weighted average of indication-specific threshold prices such that reimbursement of the more valuable indications subsidize reimbursement of the less valuable indications.With a single price and indication-specific coverage decisions, the manufacturer may select a high price with fewer patients treated than in the first-best solution. There are also cases in which the manufacturer selects a lower price, resulting in reimbursement for more indications and positive consumer surplus.
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Custos de Medicamentos , Humanos , Análise Custo-BenefícioRESUMO
BACKGROUND: Sodium-glucose cotransporter-2 (SGLT2) inhibitors have the potential to alter the natural history of chronic kidney disease (CKD), and they should be included in cost-effectiveness analyses of screening for CKD. OBJECTIVE: To determine the cost-effectiveness of adding population-wide screening for CKD. DESIGN: Markov cohort model. DATA SOURCES: NHANES (National Health and Nutrition Examination Survey), U.S. Centers for Medicare & Medicaid Services data, cohort studies, and randomized clinical trials, including the DAPA-CKD (Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease) trial. TARGET POPULATION: Adults. TIME HORIZON: Lifetime. PERSPECTIVE: Health care sector. INTERVENTION: Screening for albuminuria with and without adding SGLT2 inhibitors to the current standard of care for CKD. OUTCOME MEASURES: Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs), all discounted at 3% annually. RESULTS OF BASE-CASE ANALYSIS: One-time CKD screening at age 55 years had an ICER of $86 300 per QALY gained by increasing costs from $249 800 to $259 000 and increasing QALYs from 12.61 to 12.72; this was accompanied by a decrease in the incidence of kidney failure requiring dialysis or kidney transplant of 0.29 percentage points and an increase in life expectancy from 17.29 to 17.45 years. Other options were also cost-effective. During ages 35 to 75 years, screening once prevented dialysis or transplant in 398 000 people and screening every 10 years until age 75 years cost less than $100 000 per QALY gained. RESULTS OF SENSITIVITY ANALYSIS: When SGLT2 inhibitors were 30% less effective, screening every 10 years during ages 35 to 75 years cost between $145 400 and $182 600 per QALY gained, and price reductions would be required for screening to be cost-effective. LIMITATION: The efficacy of SGLT2 inhibitors was derived from a single randomized controlled trial. CONCLUSION: Screening adults for albuminuria to identify CKD could be cost-effective in the United States. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality, Veterans Affairs Office of Academic Affiliations, and National Institute of Diabetes and Digestive and Kidney Diseases.
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Insuficiência Renal Crônica , Inibidores do Transportador 2 de Sódio-Glicose , Adulto , Humanos , Estados Unidos , Idoso , Pessoa de Meia-Idade , Análise de Custo-Efetividade , Inquéritos Nutricionais , Albuminúria , Análise Custo-Benefício , Medicare , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/diagnóstico , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND: Under the current US kidney allocation system, older candidates receive a disproportionately small share of deceased donor kidneys despite a reserve of potentially usable kidneys that could shorten their wait times. To consider potential health gains from increasing access to kidneys for these candidates, we developed and calibrated a microsimulation model of the transplantation process and long-term outcomes for older deceased donor kidney transplant candidates. METHODS: We estimated risk equations for transplant outcomes using the Scientific Registry of Transplant Recipients (SRTR), which contains data on all US transplants (2010-2019). A microsimulation model combined these equations to account for competing events. We calibrated the model to key transplant outcomes and used acceptance sampling, retaining the best-fitting 100 parameter sets. We then examined life expectancy gains from allocating kidneys even of lower quality across patient subgroups defined by age and designated race/ethnicity. RESULTS: The best-fitting 100 parameter sets (among 4,000,000 sampled) enabled our model to closely match key transplant outcomes. The model demonstrated clear survival benefits for those who receive a deceased donor kidney, even a lower quality one, compared with remaining on the waitlist where there is a risk of removal. The expected gain in survival from receiving a lower quality donor kidney was consistent gains across age and race/ethnic subgroups. LIMITATIONS: Limited available data on socioeconomic factors. CONCLUSIONS: Our microsimulation model accurately replicates a range of key kidney transplant outcomes among older candidates and demonstrates that older candidates may derive substantial benefits from transplantation with lower quality kidneys. This model can be used to evaluate policies that have been proposed to address concerns that the current system disincentivizes deceased donor transplants for older patients. HIGHLIGHTS: The microsimulation model was consistent with the data after calibration and accurately simulated the transplantation process for older deceased donor kidney transplant candidates.There are clear survival benefits for older transplant candidates who receive deceased donor kidneys, even lower quality ones, compared with remaining on the waitlist.This model can be used to evaluate policies aimed at increasing transplantation among older candidates.
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Transplante de Rim , Doadores de Tecidos , Transplantados , Humanos , Transplante de Rim/métodos , Medição de Risco , Fatores Etários , Simulação por Computador , Estados Unidos , Resultado do TratamentoRESUMO
OBJECTIVE: To evaluate the cost effectiveness of California's statewide perinatal quality collaborative for reducing severe maternal morbidity (SMM) from hemorrhage. METHODS: A decision-analytic model using open source software (Amua 0.30) compared outcomes and costs within a simulated cohort of 480,000 births to assess the annual effect in the state of California. Our model captures both the short-term costs and outcomes that surround labor and delivery and long-term effects over a person's remaining lifetime. Previous studies that evaluated the effectiveness of the CMQCC's (California Maternal Quality Care Collaborative) statewide perinatal quality collaborative initiative-reduction of hemorrhage-related SMM by increasing recognition, measurement, and timely response to postpartum hemorrhage-provided estimates of intervention effectiveness. Primary cost data received from select hospitals within the study allowed for the estimation of collaborative costs, with all other model inputs derived from literature. Costs were inflated to 2021 dollars with a cost-effectiveness threshold of $100,000 per quality-adjusted life-year (QALY) gained. Various sensitivity analyses were performed including one-way, scenario-based, and probabilistic sensitivity (Monte Carlo) analysis. RESULTS: The collaborative was cost effective, exhibiting strong dominance when compared with the baseline or standard of care. In a theoretical cohort of 480,000 births, collaborative implementation added 182 QALYs (0.000379/birth) by averting 913 cases of SMM, 28 emergency hysterectomies, and one maternal mortality. Additionally, it saved $9 million ($17.78/birth) due to averted SMM costs. Although sensitivity analyses across parameter uncertainty ranges provided cases where the intervention was not cost saving, it remained cost effective throughout all analyses. Additionally, scenario-based sensitivity analysis found the intervention cost effective regardless of birth volume and implementation costs. CONCLUSION: California's statewide perinatal quality collaborative initiative to reduce SMM from hemorrhage was cost effective-representing an inexpensive quality-improvement initiative that reduces the incidence of maternal morbidity and mortality, and potentially provides cost savings to the majority of birthing hospitals.
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Trabalho de Parto , Hemorragia Pós-Parto , Gravidez , Feminino , Humanos , Análise de Custo-Efetividade , Hemorragia Pós-Parto/prevenção & controle , Mortalidade Materna , Análise Custo-Benefício , Anos de Vida Ajustados por Qualidade de VidaRESUMO
Importance: Emergency departments (EDs) with high pediatric readiness (coordination, personnel, quality improvement, safety, policies, and equipment) are associated with lower mortality among children with critical illness and those admitted to trauma centers, but the benefit among children with more diverse clinical conditions is unknown. Objective: To evaluate the association between ED pediatric readiness, in-hospital mortality, and 1-year mortality among injured and medically ill children receiving emergency care in 11 states. Design, Setting, and Participants: This is a retrospective cohort study of children receiving emergency care at 983 EDs in 11 states from January 1, 2012, through December 31, 2017, with follow-up for a subset of children through December 31, 2018. Participants included children younger than 18 years admitted, transferred to another hospital, or dying in the ED, stratified by injury vs medical conditions. Data analysis was performed from November 1, 2021, through June 30, 2022. Exposure: ED pediatric readiness of the initial ED, measured through the weighted Pediatric Readiness Score (wPRS; range, 0-100) from the 2013 National Pediatric Readiness Project assessment. Main Outcomes and Measures: The primary outcome was in-hospital mortality, with a secondary outcome of time to death to 1 year among children in 6 states. Results: There were 796â¯937 children, including 90â¯963 (11.4%) in the injury cohort (mean [SD] age, 9.3 [5.8] years; median [IQR] age, 10 [4-15] years; 33â¯516 [36.8%] female; 1820 [2.0%] deaths) and 705â¯974 (88.6%) in the medical cohort (mean [SD] age, 5.8 [6.1] years; median [IQR] age, 3 [0-12] years; 329â¯829 [46.7%] female, 7688 [1.1%] deaths). Among the 983 EDs, the median (IQR) wPRS was 73 (59-87). Compared with EDs in the lowest quartile of ED readiness (quartile 1, wPRS of 0-58), initial care in a quartile 4 ED (wPRS of 88-100) was associated with 60% lower in-hospital mortality among injured children (adjusted odds ratio, 0.40; 95% CI, 0.26-0.60) and 76% lower mortality among medical children (adjusted odds ratio, 0.24; 95% CI, 0.17-0.34). Among 545â¯921 children followed to 1 year, the adjusted hazard ratio of death in quartile 4 EDs was 0.59 (95% CI, 0.42-0.84) for injured children and 0.34 (95% CI, 0.25-0.45) for medical children. If all EDs were in the highest quartile of pediatric readiness, an estimated 288 injury deaths (95% CI, 281-297 injury deaths) and 1154 medical deaths (95% CI, 1150-1159 medical deaths) may have been prevented. Conclusions and Relevance: These findings suggest that children with injuries and medical conditions treated in EDs with high pediatric readiness had lower mortality during hospitalization and to 1 year.
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Serviço Hospitalar de Emergência , Centros de Traumatologia , Criança , Humanos , Feminino , Pré-Escolar , Recém-Nascido , Lactente , Masculino , Estudos Retrospectivos , Tratamento de Emergência , Mortalidade HospitalarRESUMO
BACKGROUND: Historically, correctional facilities have had large outbreaks of respiratory infectious diseases like COVID-19. Hence, importation and exportation of such diseases from correctional facilities raises substantial concern. METHODS: We developed a stochastic simulation model of transmission of respiratory infectious diseases within and between correctional facilities and the community. We investigated the infection dynamics, key governing factors, and relative importance of different infection routes (e.g., incarcerations and releases versus correctional staff). We also developed machine-learning meta-models of the simulation model, which allowed us to examine how our findings depended on different disease, correctional facility, and community characteristics. RESULTS: We find a magnification-reflection dynamic: a small outbreak in the community can cause a larger outbreak in the correction facility, which can then cause a second, larger outbreak in the community. This dynamic is strongest when community size is relatively small as compared with the size of the correctional population, the initial community R-effective is near 1, and initial prevalence of immunity in the correctional population is low. The timing of the correctional magnification and community reflection peaks in infection prevalence are primarily governed by the initial R-effective for each setting. Because the release rates from prisons are low, our model suggests correctional staff may be a more important infection entry route into prisons than incarcerations and releases; in jails, where incarceration and release rates are much higher, our model suggests the opposite. CONCLUSIONS: We find that across many combinations of respiratory pathogens, correctional settings, and communities, there can be substantial magnification-reflection dynamics, which are governed by several key factors. Our goal was to derive theoretical insights relevant to many contexts; our findings should be interpreted accordingly. HIGHLIGHTS: We find a magnification-reflection dynamic: a small outbreak in a community can cause a larger outbreak in a correctional facility, which can then cause a second, larger outbreak in the community.For public health decision makers considering contexts most susceptible to this dynamic, we find that the dynamic is strongest when the community size is relatively small, initial community R-effective is near 1, and the initial prevalence of immunity in the correctional population is low; the timing of the correctional magnification and community reflection peaks in infection prevalence are primarily governed by the initial R-effective for each setting.We find that correctional staff may be a more important infection entry route into prisons than incarcerations and releases; however, for jails, the relative importance of the entry routes may be reversed.For modelers, we combine simulation modeling, machine-learning meta-modeling, and interpretable machine learning to examine how our findings depend on different disease, correctional facility, and community characteristics; we find they are generally robust.
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COVID-19 , Doenças Transmissíveis , Humanos , COVID-19/epidemiologia , Prisões , Surtos de Doenças , Saúde Pública , Doenças Transmissíveis/epidemiologiaRESUMO
PURPOSE: The goal of this study is to develop an approach for estimating nationally representative quality-adjusted life-year (QALY) loss from injury and poisoning conditions using data collected in the Medical Expenditure Panel Survey (MEPS) and the National Health Interview Survey (NHIS). METHODS: This study uses data from the 2002-2015 NHIS and MEPS surveys. Injuries were identified in the MEPS medical events file and through self-reporting of medical conditions. We restricted our model to 163,731 adults, for which we predict a total of 294,977 EQ-5D scores using responses to the self-administered questionnaire. EQ-5D scores were modeled using age, sex, comorbidities, and binary indicators of the presence and duration of injury at the time of the health status questionnaire. These models consider nonlinearity over time during the first 3 y following the injury event. RESULTS: Injuries are identified in MEPS using medical events that provide a reasonable proxy for the date of injury occurrence. Health-related quality of life (HRQL) decrements can be estimated using binary indicators of injury during different time periods. When grouped into 29 injury categories, most categories were statistically significant predictors of HRQL scores in the first year after injury. For these groups of injuries, mean first-year QALY loss estimates range from 0.005 (sprains and strains of joints and adjacent muscles, n = 7067) to 0.109 (injury to nerves and spinal cord, n = 71). Fewer estimates are significant in the second and third years after injury, which may reflect a return to baseline HRQL. CONCLUSION: This research presents both a framework for estimating QALY loss for short-lived medical conditions and nationally representative, community-based HRQL scores associated with a wide variety of injury and poisoning conditions. HIGHLIGHTS: This research provides a catalog of nationally representative, preference-based EQ-5D score decrements associated with surviving a large set of injuries, based on patient-reported health status.Mean first-year QALY loss estimates range from 0.005 (sprains and strains of joints and adjacent muscles, n = 7067) to 0.109 (injury to nerves and spinal cord, n = 71).This article presents a novel methodology for assessing quality-of-life impacts for acute conditions by calculating the time elapsed between injury and health status elicitation. Researchers may explore adapting these methods to study other short-lived conditions and health states, such as COVID-19 or chemotherapy.