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OBJECTIVES: Cancer therapies targeting tumor-agnostic biomarkers are challenging traditional health technology assessment (HTA) frameworks. The high prevalence of nonrandomized single-arm trials, heterogeneity, and small benefiting populations are driving outcomes uncertainty, challenging healthcare decision making. We conducted a structured literature review to identify barriers and prioritize solutions to generating economic evidence for tumor-agnostic therapies. METHODS: We searched MEDLINE and Embase for English-language studies conducting economic evaluations of tumor-agnostic treatments or exploring related challenges and solutions. We included studies published by December 2022 and supplemented our review with Canadian Agency for Drugs and Technologies in Health and National Institute for Health and Care Excellence technical reports for approved tumor-agnostic therapies. Three reviewers abstracted and summarized key methodological and empirical study characteristics. Challenges and solutions were identified through authors' statements and categorized using directed content analysis. RESULTS: Twenty-six studies met our inclusion criteria. Studies spanned economic evaluations (n = 5), reimbursement reviews (n = 4), qualitative research (n = 1), methods validations (n = 3), and commentaries or literature reviews (n = 13). Challenges encountered related to (1) the treatment setting and clinical trial designs, (2) a lack of data or low-quality data on clinical and cost parameters, and (3) an inability to produce evidence that meets HTA guidelines. Although attempted solutions centered on analytic approaches for managing missing data, proposed solutions highlighted the need for real-world evidence combined with life-cycle HTA to reduce future evidentiary uncertainty. CONCLUSIONS: Therapeutic innovation outpaces HTA evidence generation and the methods that support it. Existing HTA frameworks must be adapted for tumor-agnostic treatments to support future economic evaluations enabling timely patient access.
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Neoplasias , Humanos , Análise Custo-Benefício , Canadá , Neoplasias/terapia , IncertezaRESUMO
PURPOSE: Using data from a randomized controlled trial for treatment of prescription-type opioid use disorder in Canada, this study examines sensitivity to change in three preference-based instruments [EQ-5D-3L, EQ-5D-5L, and the Health Utilities Index Mark 3 (HUI3)] and explores an oft-overlooked consideration when working with contemporaneous responses for similar questions-data quality. METHODS: Analyses focused on the relative abilities of three instruments to capture change in health status. Distributional methods were used to categorize individuals as 'improved' or 'not improved' for eight anchors (seven clinical, one generic). Sensitivity to change was assessed using area under the ROC (receiver operating characteristics) curve (AUC) analysis and comparisons of mean change scores for three time periods. A 'strict' data quality criteria, defined a priori, was applied. Analyses were replicated using 'soft' and 'no' criteria. RESULTS: Data from 160 individuals were used in the analysis; 30% had at least one data quality violation at baseline. Despite mean index scores being significantly lower for the HUI3 compared with EQ-5D instruments at each time point, the magnitudes of change scores were similar. No instrument demonstrated superior sensitivity to change. While six of the 10 highest AUC estimates were for the HUI3, 'moderate' classifications of discriminative ability were identified in 12 (of 22) analyses for each EQ-5D instrument, compared with eight for the HUI3. CONCLUSION: Negligible differences were observed between the EQ-5D-3L, EQ-5D-5L, and HUI3 regarding the ability to measure change. The prevalence of data quality violations-which differed by ethnicity-requires further investigation.
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Nível de Saúde , Qualidade de Vida , Humanos , Qualidade de Vida/psicologia , Reprodutibilidade dos Testes , Inquéritos e Questionários , Psicometria/métodos , Canadá , PrescriçõesRESUMO
Background: Despite significant progress in HIV treatment and prevention, the US remains far from its goal of 'Ending the HIV Epidemic' by 2030. Economic models using local data can synthesise the evidence to help policymakers allocate HIV resources efficiently, but persistent research-to-practice gaps remain. Little is known about how to facilitate the use of economic modelling data among local public health policymakers in real-world settings. Aims and objectives: To explore the dissemination of results from a locally-calibrated economic model for HIV prevention and treatment and identify the factors influencing potential uptake of the model for public health decision making at the local level. Methods: Four virtual focus groups with 26 local health department policymakers in Baltimore, Miami, Seattle, and New York City were held between July 2020 and May 2021. Qualitative content analysis of transcripts identified key themes around using the localised economic model in policy decisions. Results: Participants were interested in using local data in their decisions to allocate resources for HIV prevention/treatment. Six themes emerged: 1) importance of understanding local policy context; 2) health equity considerations; 3) using evidence to support current priorities; 4) difficulty of changing strategies, even incrementally; 5) bang for the incremental buck (efficiency) vs. previous impact; and 6) community values. Conclusion and relevance: To optimise acceptance and use of results from economic models, researchers should engage with local community members and public health decision makers early to understand budgetary and community priorities. Participants prioritised evidence that supports their existing strategies, considers budgets and funding streams, and improves health equity; however, real-world budget constraints and conflicting interests serve as barriers to implementing model recommendations and reaching national goals.
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BACKGROUND: Widespread viral and serological testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may present a unique opportunity to also test for human immunodeficiency virus (HIV) infection. We estimated the potential impact of adding linked, opt-out HIV testing alongside SARS-CoV-2 testing on the HIV incidence and the cost-effectiveness of this strategy in 6 US cities. METHODS: Using a previously calibrated dynamic HIV transmission model, we constructed 3 sets of scenarios for each city: (1) sustained current levels of HIV-related treatment and prevention services (status quo); (2) temporary disruptions in health services and changes in sexual and injection risk behaviors at discrete levels between 0%-50%; and (3) linked HIV and SARS-CoV-2 testing offered to 10%-90% of the adult population in addition to Scenario 2. We estimated the cumulative number of HIV infections between 2020-2025 and the incremental cost-effectiveness ratios of linked HIV testing over 20 years. RESULTS: In the absence of linked, opt-out HIV testing, we estimated a total of a 16.5% decrease in HIV infections between 2020-2025 in the best-case scenario (50% reduction in risk behaviors and no service disruptions), and a 9.0% increase in the worst-case scenario (no behavioral change and 50% reduction in service access). We estimated that HIV testing (offered at 10%-90% levels) could avert a total of 576-7225 (1.6%-17.2%) new infections. The intervention would require an initial investment of $20.6M-$220.7M across cities; however, the intervention would ultimately result in savings in health-care costs in each city. CONCLUSIONS: A campaign in which HIV testing is linked with SARS-CoV-2 testing could substantially reduce the HIV incidence and reduce direct and indirect health care costs attributable to HIV.
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COVID-19 , Epidemias , Infecções por HIV , Adulto , Teste para COVID-19 , Cidades , Análise Custo-Benefício , HIV , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Humanos , SARS-CoV-2RESUMO
OBJECTIVES: To describe trends in the number of youths diagnosed with opioid use disorder (OUD) and to identify factors associated with OUD diagnosis in acute care settings. STUDY DESIGN: Data from a population-based retrospective cohort study with linkage of 6 health administrative databases for 13 009 youth age 12-24 years identified with OUD between 2001 and 2018 in British Columbia, Canada were used to describe annual diagnoses. Using a multiple logistic regression model, we estimated the association between past-year health care utilization and OUD diagnosis in acute settings, controlling for sociodemographic and OUD-related comorbid conditions. RESULTS: Annual OUD diagnoses quadrupled between 2003 and 2017 (from 326 to 1473). Among the 6579 youth diagnosed with OUD between April 1, 2013 and September 30, 2018, 88.1% had past-year health system contacts. Youth age 12-18 had higher odds of OUD diagnosis in acute care (aOR 2.04; 95% CI 1.78, 2.34). Compared with no health care contact, youth receiving outpatient care only were less likely to be diagnosed with OUD in acute care (aOR 0.69; 95% CI 0.56, 0.84) and those with >1 urgent hospitalization were more likely to be diagnosed with OUD in acute care (aOR 1.87; 95% CI 1.40,2.49). CONCLUSIONS: More than 88% of youth had past-year health system contacts prior to diagnosis. Those age 12-18 years and with urgent hospitalizations in the year prior to diagnosis were more likely to have OUD diagnosed in acute care settings. Establishing an effective evidence-based system for early detection and intervention among youth with OUD must be a priority.
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Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Adolescente , Assistência Ambulatorial/estatística & dados numéricos , Colúmbia Britânica/epidemiologia , Criança , Bases de Dados Factuais , Utilização de Instalações e Serviços/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Transtornos Relacionados ao Uso de Opioides/etiologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Prevalência , Estudos Retrospectivos , Fatores de Risco , Adulto JovemRESUMO
PURPOSE OF REVIEW: Cost-effectiveness analysis (CEA) can help identify the trade-offs decision makers face when confronted with alternative courses of action for the implementation of public health strategies. Application of CEA alongside implementation scientific studies remains limited. We aimed to identify areas for future development in order to enhance the uptake and impact of model-based CEA in implementation scientific research. RECENT FINDINGS: Important questions remain about how to broadly implement evidence-based public health interventions in routine practice. Establishing population-level implementation strategy components and distinct implementation phases, including planning for implementation, the time required to scale-up programs, and sustainment efforts required to maintain them, can help determine the data needed to quantify each of these elements. Model-based CEA can use these data to determine the added value associated with each of these elements across systems, settings, population subgroups, and levels of implementation to provide tailored guidance for evidence-based public health action. There is a need to integrate implementation science explicitly into CEA to adequately capture diverse real-world delivery contexts and make detailed, informed recommendations on the aspects of the implementation process that provide good value. We describe examples of how model-based CEA can integrate implementation scientific concepts and evidence to help tailor evaluations to local context. We also propose six distinct domains for methodological advancement in order to enhance the uptake and impact of model-based cost-effectiveness analysis in implementation scientific research.
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Infecções por HIV , Ciência da Implementação , Análise Custo-Benefício , Humanos , Saúde PúblicaRESUMO
Opioid agonist treatment (OAT) is the evidence-based standard of care for people with opioid use disorder. In British Columbia, Canada, only social assistance registrants received full coverage for OAT prior to the introduction of the Pharmacare Plan G coverage expansion on February 1st, 2017. We aimed to determine the effect of the coverage expansion on OAT initiation, re-initiation, and retention. Using linked population-level data, we executed a difference-in-differences analysis to compare outcomes of individuals eligible for the additional coverage and social assistance registrants already receiving the most generous coverage for OAT prior to the policy change, adjusting for individual and prescriber characteristics. We found Plan G coverage expansion significantly increased OAT retention. Specifically, coverage expansion decreased the number of OAT episode discontinuations by 12.8% (95% CI: 8.4%, 17.2%).
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Analgésicos Opioides , Transtornos Relacionados ao Uso de Opioides , Analgésicos Opioides/uso terapêutico , Colúmbia Britânica , Etnicidade , Humanos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológicoRESUMO
BACKGROUND: Persons who inject drugs (PWID) are at a disproportionately high risk of HIV infection. We aimed to determine the highest-valued combination implementation strategies to reduce the burden of HIV among PWID in 6 US cities. METHODS: Using a dynamic HIV transmission model calibrated for Atlanta, Baltimore, Los Angeles, Miami, New York City, and Seattle, we assessed the value of implementing combinations of evidence-based interventions at optimistic (drawn from best available evidence) or ideal (90% coverage) scale-up. We estimated reduction in HIV incidence among PWID, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) for each city (10-year implementation; 20-year horizon; 2018 $ US). RESULTS: Combinations that maximized health benefits contained between 6 (Atlanta and Seattle) and 12 (Miami) interventions with ICER values ranging from $94 069/QALY in Los Angeles to $146â 256/QALY in Miami. These strategies reduced HIV incidence by 8.1% (credible interval [CI], 2.8%-13.2%) in Seattle and 54.4% (CI, 37.6%-73.9%) in Miami. Incidence reduction reached 16.1%-75.5% at ideal scale. CONCLUSIONS: Evidence-based interventions targeted to PWID can deliver considerable value; however, ending the HIV epidemic among PWID will require innovative implementation strategies and supporting programs to reduce social and structural barriers to care.
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Epidemias/prevenção & controle , Infecções por HIV/epidemiologia , Medicina Preventiva/economia , Anos de Vida Ajustados por Qualidade de Vida , Abuso de Substâncias por Via Intravenosa/reabilitação , Adolescente , Adulto , Cidades/epidemiologia , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Usuários de Drogas/estatística & dados numéricos , Epidemias/economia , Epidemias/estatística & dados numéricos , Feminino , Infecções por HIV/economia , Infecções por HIV/prevenção & controle , Infecções por HIV/transmissão , Teste de HIV/economia , Custos de Cuidados de Saúde , Implementação de Plano de Saúde/economia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Tratamento de Substituição de Opiáceos/economia , Tratamento de Substituição de Opiáceos/métodos , Profilaxia Pré-Exposição/economia , Profilaxia Pré-Exposição/organização & administração , Prevalência , Medicina Preventiva/organização & administração , Abuso de Substâncias por Via Intravenosa/complicações , Abuso de Substâncias por Via Intravenosa/economia , Estados Unidos/epidemiologia , Adulto JovemRESUMO
We estimated human immunodeficiency virus incidence and incidence rate ratios (IRRs) for black and Hispanic vs white populations in 6 cities in the United States (2020-2030). Large reductions in incidence are possible, but without elimination of disparities in healthcare access, we found that wide disparities persisted for black compared with white populations in particular (lowest IRR, 1.69 [95% credible interval, 1.19-2.30]).
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Epidemias , Grupos Raciais , Cidades , Etnicidade , HIV , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde , Hispânico ou Latino , Humanos , Estados Unidos/epidemiologiaRESUMO
OBJECTIVES: The ambitious goals of the US Ending the HIV Epidemic initiative will require a targeted, context-specific public health response. Model-based economic evaluation provides useful guidance for decision making while characterizing decision uncertainty. We aim to quantify the value of eliminating uncertainty about different parameters in selecting combination implementation strategies to reduce the public health burden of HIV/AIDS in 6 US cities and identify future data collection priorities. METHODS: We used a dynamic compartmental HIV transmission model developed for 6 US cities to evaluate the cost-effectiveness of a range of combination implementation strategies. Using a metamodeling approach with nonparametric and deep learning methods, we calculated the expected value of perfect information, representing the maximum value of further research to eliminate decision uncertainty, and the expected value of partial perfect information for key groups of parameters that would be collected together in practice. RESULTS: The population expected value of perfect information ranged from $59 683 (Miami) to $54 108 679 (Los Angeles). The rank ordering of expected value of partial perfect information on key groups of parameters were largely consistent across cities and highest for parameters pertaining to HIV risk behaviors, probability of HIV transmission, health service engagement, HIV-related mortality, health utility weights, and healthcare costs. Los Angeles was an exception, where parameters on retention in pre-exposure prophylaxis ranked highest in contributing to decision uncertainty. CONCLUSIONS: Funding additional data collection on HIV/AIDS may be warranted in Baltimore, Los Angeles, and New York City. Value of information analysis should be embedded into decision-making processes on funding future research and public health intervention.
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Coleta de Dados/métodos , Tomada de Decisões Gerenciais , Erradicação de Doenças/métodos , Infecções por HIV/prevenção & controle , Adolescente , Adulto , Análise Custo-Benefício , Coleta de Dados/economia , Erradicação de Doenças/economia , Erradicação de Doenças/organização & administração , Feminino , Infecções por HIV/economia , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Incerteza , Estados Unidos/epidemiologia , População Urbana/estatística & dados numéricos , Adulto JovemRESUMO
We estimated 10-year (2020-2030) trajectories for human immunodeficiency virus incidence in 6 US cities. Estimated incidence will only decrease in 2 of 6 cities, with the overall population-weighted incidence decreasing 3.1% (95% credible interval [CrI], -1.0% to 8.5%) by 2025, and 4.3% (95% CrI, -2.6% to 12.7%) by 2030 across cities. Targeted, context-specific combination implementation strategies will be necessary to meet the newly established national targets.
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Infecções por HIV/epidemiologia , Infecções por HIV/virologia , HIV , Síndrome da Imunodeficiência Adquirida/epidemiologia , Síndrome da Imunodeficiência Adquirida/prevenção & controle , Síndrome da Imunodeficiência Adquirida/virologia , Cidades , Infecções por HIV/prevenção & controle , Humanos , Incidência , Vigilância da População , Estados Unidos/epidemiologiaRESUMO
Background: Only 1 in 5 of the nearly 2.4 million Americans with an opioid use disorder received treatment in 2015. Fewer than half of Californians who received treatment in 2014 received opioid agonist treatment (OAT), and regulations for admission to OAT in California are more stringent than federal regulations. Objective: To determine the cost-effectiveness of OAT for all treatment recipients compared with the observed standard of care for patients presenting with opioid use disorder to California's publicly funded treatment facilities. Design: Model-based cost-effectiveness analysis. Data Sources: Linked population-level administrative databases capturing treatment and criminal justice records for California (2006 to 2010); published literature. Target Population: Persons initially presenting for publicly funded treatment of opioid use disorder. Time Horizon: Lifetime. Perspective: Societal. Intervention: Immediate access to OAT with methadone for all treatment recipients compared with the observed standard of care (54.3% initiate opioid use disorder treatment with medically managed withdrawal). Outcome Measures: Discounted quality-adjusted life-years (QALYs) and discounted costs. Results of Base-Case Analysis: Immediate access to OAT for all treatment recipients costs less (by $78 257), with patients accumulating more QALYs (by 0.42) than with the observed standard of care. In a hypothetical scenario where all Californians starting treatment of opioid use disorder in 2014 had immediate access to OAT, total lifetime savings for this cohort could be as high as $3.8 billion. Results of Sensitivity Analysis: 99.6% of the 2000 simulations resulted in lower costs and more QALYs. Limitation: Nonrandomized delivery of OAT or medically managed withdrawal. Conclusion: The value of publicly funded treatment of opioid use disorder in California is maximized when OAT is delivered to all patients presenting for treatment, providing greater health benefits and cost savings than the observed standard of care. Primary Funding Source: National Institute on Drug Abuse.
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Metadona/uso terapêutico , Entorpecentes/uso terapêutico , Tratamento de Substituição de Opiáceos/economia , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Adulto , California/epidemiologia , Análise Custo-Benefício , Feminino , Humanos , Masculino , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Anos de Vida Ajustados por Qualidade de VidaRESUMO
Background: Recognition of the secondary preventive benefits of antiretroviral therapy (ART) has mobilized global efforts to "seek, test, treat, and retain" people living with human immunodeficiency virus [HIV]/AIDS (PLHIV) in HIV care. We aimed to determine the cost-effectiveness of a set of HIV testing and treatment engagement interventions initiated in British Columbia, Canada, in 2011-2013. Methods: Using a previously validated dynamic HIV transmission model, linked individual-level health administrative data for PLHIV, and aggregate-level HIV testing data, we estimated the cost-effectiveness of primary care testing (hospital, emergency department [ED], outpatient), ART initiation, and ART retention initiatives vs a counterfactual scenario that approximated the status quo. HIV incidence, mortality, costs (in 2015$CDN), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios were estimated. Analyses were executed over 5- to 25-year time horizons from a government-payer perspective. Results: ED testing was the best value at $30216 per QALY gained and had the greatest impact on incidence and mortality among PLHIV, while ART initiation provided the greatest QALY gains. The ART retention initiative was not cost-effective. Delivered in combination at the observed scale and sustained throughout the study period, we estimated a 12.8% reduction in cumulative HIV incidence and a 4.7% reduction in deaths among PLHIV at $55258 per QALY gained. Results were most sensitive to uncertainty in the number of undiagnosed PLHIV. Conclusions: HIV testing and ART initiation interventions were cost-effective, while the ART retention intervention was not. Developing strategies to reengage PLHIV lost to care is a priority moving forward.
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Fármacos Anti-HIV/economia , Fármacos Anti-HIV/uso terapêutico , Análise Custo-Benefício , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , HIV-1 , Adulto , Terapia Antirretroviral de Alta Atividade/economia , Colúmbia Britânica/epidemiologia , Feminino , Infecções por HIV/epidemiologia , Humanos , Masculino , Modelos Econômicos , Reprodutibilidade dos Testes , Fatores de TempoRESUMO
Increased awareness of the secondary preventive benefits of antiretroviral treatment (ART) has strengthened the desire to optimize health care systems' response to HIV/AIDS. We identified clusters of health resource utilization (HRU) among people living with HIV (PLHIV) to inform targeted interventions aimed to optimize the cascade of HIV care. Using linked population-level health databases in British Columbia, Canada, we selected two analytic samples of PLHIV with 3 years of follow-up between 2006-2011 that were classified as intermittently retained in care or intermittently engaged in ART, and executed a probabilistic model-based clustering analysis for each sample with 5 and 9 quarterly HRU variables, respectively. We found clear HRU profile differences among both samples with similar HIV-related care: one featured active involvement in non-HIV care, the other little or no health care interaction following linkage to care. Differential reengagement intervention strategies capitalizing on missed opportunities in non-HIV care and further engaging physicians delivering HIV care are needed to optimize the response to the HIV epidemic.
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Antirretrovirais/uso terapêutico , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Recursos em Saúde , Administração de Serviços de Saúde/estatística & dados numéricos , Adulto , Idoso , Colúmbia Britânica/epidemiologia , Análise por Conglomerados , Feminino , HIV , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Administração em Saúde Pública , Sistema de RegistrosRESUMO
PURPOSE: In Canada, health data are siloed, slowing bioinnovation and evidence generation for personalized cancer care. Secured data-sharing platforms (SDSPs) can enable data analysis across silos through rapid concatenation across trial and real-world settings and timely researcher access. To motivate patient participation and trust in research, it is critical to ensure that SDSP design and oversight align with patients' values and address their concerns. We sought to qualitatively characterize patient preferences for the design of a pan-Canadian SDSP. METHODS: Between January 2022 and July 2023, we conducted pan-Canadian virtual focus groups with individuals who had a personal history of cancer. Following each focus group, participants were invited to provide feedback on early-phase analysis results via a member-checking survey. Three trained qualitative researchers analyzed data using thematic analysis. RESULTS: Twenty-eight individuals participated across five focus groups. Four focus groups were conducted in English and one in French. Thematic analysis generated two major and five minor themes. Analytic themes spanned personal and population implications of data sharing and willingness to manage perceived risks. Participants were supportive of increasing access to health data for precision oncology research, while voicing concerns about unintended data use, reidentification, and inequitable access to costly therapeutics. To mitigate perceived risks, participants highlighted the value of data access oversight and governance and informational transparency. CONCLUSION: Strategies for secured data sharing should anticipate and mitigate the risks that patients perceive. Participants supported enhancing timely research capability while ensuring safeguards to protect patient autonomy and privacy. Our study informs the development of data-governance and data-sharing frameworks that integrate real-world and trial data, informed by evidence from direct patient input.
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Grupos Focais , Disseminação de Informação , Preferência do Paciente , Medicina de Precisão , Humanos , Canadá , Feminino , Masculino , Medicina de Precisão/métodos , Pessoa de Meia-Idade , Adulto , Idoso , Oncologia , Neoplasias/terapia , Neoplasias/psicologiaRESUMO
BACKGROUND: Our objective was to examine the cost-effectiveness of flexible take-home buprenorphine-naloxone (BNX) versus methadone alongside the OPTIMA trial in Canada. METHODS: The OPTIMA study was a pragmatic, open-label, noninferiority, two-arm randomized controlled trial, to assess the comparative effectiveness of flexible take-home BNX vs. methadone in routine clinical care for individuals with prescription-type opioid use disorder. We evaluated cost-effectiveness using a semi-Markov cohort model. Probabilities of overdose were calibrated, accounting for fentanyl prevalence and other overdose risk factors such as naloxone availability. We considered health sector and societal cost perspectives, including costs (2020 CAD) for treatment, health resource use, criminal activity, and health state-specific preference weights as outcomes to calculate incremental cost-effectiveness ratios. Six-month and lifetime (3% annual discount rate) time-horizons were explored. RESULTS: Over a lifetime time horizon, individuals accumulated -0.144 [CI: -0.302, -0.025] incremental quality-adjusted life years (QALYs) in BNX compared with methadone. Incremental costs were -$2047 [CI: -$39,197, $24,250] from a societal perspective, and -$4549 [CI: -$6332, -$3001] from a health sector perspective. Over a six-month time-horizon, individuals accumulated 0.002 [credible interval (CI): -0.011, 0.016] incremental QALYs in BNX compared with methadone. Incremental costs were -$307 [CI: -$10,385, $8466] from a societal perspective and -$1111 [CI: -$1517, -$631] from a health sector perspective. BNX was dominated (costlier, less effective) in 49.7% of simulations when adopting a societal perspective over a lifetime time horizon. CONCLUSIONS: Flexible take-home BNX was not cost-effective versus methadone over a lifetime time horizon, resulting from better treatment retention in methadone compared to BNX.
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Buprenorfina , Transtornos Relacionados ao Uso de Opioides , Humanos , Metadona/uso terapêutico , Combinação Buprenorfina e Naloxona/uso terapêutico , Análise Custo-Benefício , Tratamento de Substituição de Opiáceos/métodos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Prescrições , Analgésicos Opioides/uso terapêutico , Buprenorfina/uso terapêutico , Antagonistas de Entorpecentes/uso terapêuticoRESUMO
The COVID-19 pandemic has amplified mental health problems and highlighted inequitable gaps in care worldwide. In response there has been an explosion of digital interventions such as smartphone applications ("apps") to extend care. The objective of this trial is to evaluate the effectiveness and cost-effectiveness of a digital depression intervention (VMood), delivered via a smartphone app. VMood is adapted from an in-person intervention that was delivered by non-specialist providers and shown to be effective in the Vietnamese context in our previous trial (2016-2019). A stepped-wedge, randomized controlled trial will be conducted across eight provinces in Vietnam. Adults aged 18 years and over will be recruited through community-based primary care centres and screened for depression using the embedded Patient Health Questionnaire-9 (primary outcome measure). Participants scoring 10-19, indicating depression caseness, will be randomly allocated to the intervention or control group until the target of 336 is reached. Secondary outcome measures will examine the effect of the intervention on commonly co-occuring anxiety, quality of life and work productivity, along with use of alcohol and tobacco products. Assessments will be administered through an online survey platform (REDCap) at baseline, and at every 3 months until 3 months post-intervention. Intervention-group participants will receive VMood for a 3-month period, with online support provided by social workers. Control-group participants will receive a limited version of the app until they cross into the intervention group. Generalized Linear Mixed-effect Models for clustered measures will be used for all outcomes data. We will conduct a cost-effectiveness analysis alongside the trial to capture VMood's costs and benefits. This trial will provide evidence on the effectiveness and cost-effectiveness of a digital mental health intervention adapted from an in-person intervention. This trial will also contribute important information to the growing and promising field of digital mental health. Trail regulation. Registered at ClinicalTrials.gov, identifier [NCT05783531].
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COVID-19 , Aplicativos Móveis , Adulto , Humanos , Adolescente , Vietnã , Análise Custo-Benefício , Depressão , Pandemias , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: The province of British Columbia, Canada, changed the existing oral anhydrous methadone solution to a 10-times more concentrated pre-mixed solution, Methadose®, on February 1, 2014. We aimed to assess the immediate effects of the methadone reformulation on missed doses, days off methadone, changes in medication dosing and dispensations of opioids for pain, and hospitalizations and mortality among all people receiving treatment at or near the time of the change. METHODS: We conducted a population-based retrospective cohort study including all individuals receiving at least one methadone dispensation in the 12 months prior to the study period. We executed a difference-in-differences analysis by estimating a multivariate regression model to compare outcomes in the three months before and after the reformulation (November 1, 2013 to April 30, 2014) versus a time-lagged control cohort with similar characteristics observed during an equivalent nonoverlapping interval. We used daily individual-level linked health administrative data capturing missed doses, days off methadone, changes in methadone dosing, concurrent dispensations of opioids for pain, hospitalizations, and mortality. We stratified the cohorts into three subgroups: (i) those receiving OAT for ≥12 months; (ii) those receiving OAT for <12 months; and (iii) those not receiving OAT at the start of the study period. We conducted sensitivity analyses and placebo tests to assess the robustness of our results. RESULTS: Among the 16,339 individuals receiving methadone during the study period, the reformulation was associated with more instances of methadone dose increases (34.5% [95% Confidence Interval (CI): 27.4%, 41.5%]). For those retained in treatment ≥12 months prior to the study period (n = 7449), the reformulation was associated with more instances of methadone dose increases (50.2% [39.5%, 60.8%]) and dispensations of opioids for pain (62.2% [40.8%, 83.5%]), as well as an increase in missed doses (41.9% [29.1%, 54.7%]) and days off methadone (62.6% [39.7%, 85.4%]). We found no statistically significant change in risk of hospitalization or mortality. Sensitivity analyses supported our results. CONCLUSION: Our results reinforce the need expressed by people receiving methadone for greater client involvement in the planning and implementation of regulatory changes that may impact client care, especially those patients with a relatively long treatment history.
Assuntos
Metadona , Transtornos Relacionados ao Uso de Opioides , Analgésicos Opioides/uso terapêutico , Colúmbia Britânica , Humanos , Metadona/uso terapêutico , Tratamento de Substituição de Opiáceos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Dor/tratamento farmacológico , Estudos RetrospectivosRESUMO
BACKGROUND: Understanding the sources of HIV transmission provides a basis for prioritizing HIV prevention resources in specific geographic regions and populations. This study estimated the number, proportion, and rate of HIV transmissions attributable to individuals along the HIV care continuum within different HIV transmission risk groups in 6 US cities. METHODS: We used a dynamic, compartmental HIV transmission model that draws on racial behavior-specific or ethnic behavior-specific and risk behavior-specific linkage to HIV care and use of HIV prevention services from local, state, and national surveillance sources. We estimated the rate and number of HIV transmissions attributable to individuals in the stage of acute undiagnosed HIV, nonacute undiagnosed HIV, HIV diagnosed but antiretroviral therapy (ART) naïve, off ART, and on ART, stratified by HIV transmission group for the 2019 calendar year. RESULTS: Individuals with undiagnosed nonacute HIV infection accounted for the highest proportion of total transmissions in every city, ranging from 36.8% (26.7%-44.9%) in New York City to 64.9% (47.0%-71.6%) in Baltimore. Individuals who had discontinued ART contributed to the second highest percentage of total infections in 4 of 6 cities. Individuals with acute HIV had the highest transmission rate per 100 person-years, ranging from 76.4 (58.9-135.9) in Miami to 160.2 (85.7-302.8) in Baltimore. CONCLUSION: These findings underline the importance of both early diagnosis and improved ART retention for ending the HIV epidemic in the United States. Differences in the sources of transmission across cities indicate that localized priority setting to effectively address diverse microepidemics at different stages of epidemic control is necessary.
Assuntos
Síndrome da Imunodeficiência Adquirida , Infecções por HIV , Cidades/epidemiologia , Continuidade da Assistência ao Paciente , HIV , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Humanos , Estados Unidos/epidemiologiaRESUMO
BACKGROUND AND AIMS: Prescription opioid analgesics have contributed to the development of opioid use disorder (OUD) in many individuals. We aimed to characterize non-cancer opioid prescribing for opioid-naive individuals prior to OUD identification. DESIGN: Population-based retrospective cohort study using six linked health administrative databases. SETTING: British Columbia (BC), Canada. PARTICIPANTS: People with OUD between 1 January 2001 and 30 September 2018 who initiated opioid analgesic therapy for non-cancer pain prior to OUD identification. MEASUREMENTS: Dose (morphine milligram equivalent per day), days prescribed and clinical guideline non-concordance for initial opioid prescriptions (dose ≥ 90 morphine milligram equivalent per day; ≥ 7 days prescribed; concomitant sedative prescription). We estimated the probability of non-concordant initial prescriptions by source (inpatient post-discharge, non-inpatient acute, non-acute) using logistic regression, adjusting for individual characteristics and comorbidities. FINDINGS: Among 66 372 individuals identified with OUD from 2001 to 2018, 21 331 (32.1%) received opioid analgesics prior to OUD identification. This proportion increased from 3.0% in 2001 to 41.0% in 2011, before decreasing to 34.2% in 2017. Roughly half of opioid prescriptions were attributed to non-acute care visits, peaking at 56.8% in 2007, while the proportion from inpatient visits increased from 19.7% in 2001 to 28.5% in 2017. The predicted probability of receiving non-guideline concordant prescriptions declined over time-periods across all three measures for inpatient and non-inpatient acute care, while remaining stable for non-acute care. In particular, the predicted probability of receiving ≥ 7-day prescriptions following inpatient visits decreased from 53.3% [95% confidence interval (CI) = 50.9, 55.8%] in 2001-06 to 37.2% (95% CI = 33.9, 40.5%) in 2013-18. CONCLUSIONS: Among the 66 372 individuals in British Columbia, Canada diagnosed with opioid use disorder between 2001 and 2018, more than 32% were earlier prescribed non-cancer opioid analgesics. The proportion who had received an opioid analgesic prescription prior to OUD identification peaked at more than 40% in 2011, before stabilizing between 2011 and 2016 and declining thereafter. Guideline concordance improved over time for high-dose and concomitant sedative prescribing.