RESUMO
Financial debt and incarceration are both independently associated with poor health, but there is limited research on the association between debt and health for those leaving incarceration. This exploratory study surveyed 75 people with a chronic health condition and recent incarceration to examine debt burden, financial well-being, and possible associations with self-reported health. Eighty-four percent of participants owed at least one debt, with non-legal debt being more common than legal debt. High financial stress was associated with poor self-reported health and the number of debts owed. Owing specific forms of debt was associated with poor health or high financial stress. Non-legal financial debt is common after incarceration, and related stress is associated with poor self-reported health. Future research is needed in larger populations in different geographical areas to further investigate the relationship and the impact debt may have on post-release poor health outcomes. Policy initiatives to address debt in the post-release population may improve health.
Assuntos
Inquéritos e Questionários , Humanos , Doença Crônica , AutorrelatoRESUMO
BACKGROUND: Digital breast tomosynthesis (DBT) has become a prevalent mode of breast cancer screening in recent years. Although older women are commonly screened for breast cancer, little is known about screening outcomes using DBT among older women. OBJECTIVE: To assess proximal screening outcomes with DBT compared to traditional two-dimensional(2-D) mammography among women 67-74 and women 75 and older. DESIGN: Cohort study. PARTICIPANTS: Medicare fee-for-service beneficiaries aged 67 years and older with no history of prior cancer who received a screening mammogram in 2015. MAIN MEASURES: Use of subsequent imaging (ultrasound and diagnostic mammography) as an indication of recall, breast cancer detection, and characteristics of breast cancer at the time of diagnosis. Analyses used weighted logistic regression to adjust for potential confounders. KEY RESULTS: Our study included 26,406 women aged 67-74 and 17,001 women 75 and older who were screened for breast cancer. Among women 75 and older, the rate of subsequent imaging among women screened with DBT did not differ significantly from 2-D mammography (91.8 versus 97.0 per 1,000 screening mammograms, p=0.37). In this age group, DBT was associated with 2.1 additional cancers detected per 1,000 screening mammograms compared to 2D (11.5 versus 9.4, p=0.003), though these additional cancers were almost exclusively in situ and stage I invasive cancers. For women 67-74 years old, DBT was associated with a higher rate of subsequent imaging than 2-D mammography (113.9 versus 100.3, p=0.004) and a higher rate of stage I invasive cancer detection (4.7 versus 3.7, p=0.002), but not other stages. CONCLUSIONS: Breast cancer screening with DBT was not associated with lower rates of subsequent imaging among older women. Most additional cancers detected with DBT were early stage. Whether detecting these additional early-stage cancers among older women improves health outcomes remains uncertain.
Assuntos
Neoplasias da Mama , Medicare , Idoso , Mama/diagnóstico por imagem , Densidade da Mama , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/epidemiologia , Estudos de Coortes , Detecção Precoce de Câncer/métodos , Feminino , Humanos , Lactente , Mamografia/métodos , Programas de Rastreamento/métodos , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Criminal justice system costs in the United States have exponentially increased over the last decades, and providing health care to individuals released from incarceration is costly. To better understand how to manage costs to state budgets for those who have been incarcerated, we aimed to assess state-level costs of an enhanced primary care program, Transitions Clinic Network (TCN), for chronically-ill and older individuals recently released from prison. METHODS: We linked administrative data from Connecticut Department of Correction, Medicaid, and Department of Mental Health and Addiction Services to identify a propensity matched comparison group and estimate costs of a primary care program serving chronically-ill and older individuals released from incarceration between 2013 and 2016. We matched 94 people released from incarceration who received care at a TCN program to 94 people released from incarceration who did not receive care at TCN program on numerous characteristics. People eligible for TCN program participation were released from incarceration within the prior 6 months and had a chronic health condition or were over the age of 50. We estimated 1) costs associated with the TCN program and 2) costs accrued by Medicaid and the criminal justice system. We evaluated associations between program participation and Medicaid and criminal justice system costs over a 12-month period using bivariate analyses with nonparametric bootstrapping method. RESULTS: The 12-month TCN program operating cost was estimated at $54,394 ($146 per participant per month). Average monthly Medicaid costs per participant were not statistically different between the TCN ($1737 ± $3449) and comparison ($1356 ± $2530) groups. Average monthly criminal justice system costs per participant were significantly lower among TCN group ($733 ± $1130) compared with the matched group ($1276 ± $1738, p < 0.05). We estimate every dollar invested in the TCN program yielded a 12-month return of $2.55 to the state. CONCLUSIONS: Medicaid investments in an enhanced primary care program for individuals returning from incarceration are cost neutral and positively impact state budgets by reducing criminal justice system costs.
Assuntos
Serviços de Saúde Mental , Prisões , Redução de Custos , Humanos , Medicaid , Atenção Primária à Saúde , Estados UnidosRESUMO
BACKGROUND: To date, 38 states have enacted dense breast notification (DBN) laws mandating that mammogram reports include language informing women of risks related to dense breast tissue. OBJECTIVE: Nationally representative survey to assess the association between residing in a state with a DBN law and women's awareness and knowledge about breast density, and breast cancer anxiety. DESIGN: Internet survey conducted in 2018 with participants in KnowledgePanel®, an online research panel. PARTICIPANTS: English-speaking US women ages 40-59 years without a personal history of breast cancer who had received at least one screening mammogram (N = 1928; survey completion rate 68.2%). MAIN MEASURES: (1) Reported history of increased breast density, (2) knowledge of the increased risk of breast cancer with dense breasts, (3) knowledge of the masking effect of dense breasts on mammography, and (4) breast cancer anxiety. KEY RESULTS: Women residing in DBN states were more likely to report increased breast density (43.6%) compared with women residing in non-DBN states (32.7%, p < 0.01, adjusted odds ratio, 1.70, 95% CI,1.34-2.17). Interaction effect between DBN states and education status showed that the impact of DBN on women's reporting of dense breasts was significant for women with greater than high school education, but not among women with a high school education or less (p value = 0.01 for interaction). Only 23.0% of women overall knew that increased breast density was associated with a higher risk of breast cancer, and 68.0% of women understood that dense breasts decreased the sensitivity of mammography. There were no significant differences between women in DBN states and non-DBN states for these outcomes, or for breast cancer-related anxiety. CONCLUSIONS: State DBN laws were not associated with increased understanding of the clinical implications of breast density. DBN laws were associated with a higher likelihood of women reporting increased breast density, though not among women with lower education.
Assuntos
Densidade da Mama , Neoplasias da Mama , Adulto , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/epidemiologia , Detecção Precoce de Câncer , Feminino , Humanos , Mamografia , Programas de Rastreamento , Pessoa de Meia-Idade , Inquéritos e QuestionáriosRESUMO
Perceived discrimination based on criminal record is associated with social determinants of health such as housing and employment. However, there is limited data on discrimination based on criminal record within health care settings. We examined how perceived discrimination based on criminal record within health care settings, among individuals with a history of incarceration, was associated with self-reported general health status. We used data from individuals recruited from 11 sites within the Transitions Clinic Network (TCN) who were released from prison within the prior 6 months, had a chronic health condition and/or were age 50 or older, and had complete information on demographics, medical history, self-reported general health status, and self-reported perceived discrimination (n = 743).Study participants were mostly of minority racial and ethnic background (76%), and had a high prevalence of self-reported chronic health conditions with half reporting mental health conditions and substance use disorders (52% and 50%, respectively), and 85% reporting one or more chronic medical conditions. Over a quarter (27%, n = 203) reported perceived discrimination by health care providers due to criminal record with a higher proportion of individuals with fair or poor health reporting discrimination compared to those in good or excellent health (33% vs. 23%; p = .002). After adjusting for age and reported chronic conditions, participants reporting discrimination due to criminal record had 43% increased odds of reporting fair/poor health (AOR 1.43, 95% CI 1.01-2.03). Race and ethnicity did not modify this relationship.Participants reporting discrimination due to criminal record had increased odds of reporting fair/poor health. The association between perceived discrimination by health care providers due to criminal record and health should be explored in future longitudinal studies among individuals at high risk of incarceration.Clinical Trial Registration: NCT01863290.
Assuntos
Atenção à Saúde/estatística & dados numéricos , Nível de Saúde , Grupos Minoritários/psicologia , Preconceito/psicologia , Prisioneiros/psicologia , Adulto , Doença Crônica , Etnicidade/psicologia , Feminino , Humanos , Estudos Longitudinais , Masculino , Transtornos Mentais/epidemiologia , Pessoa de Meia-Idade , Grupos Raciais/psicologia , Autorrelato , Transtornos Relacionados ao Uso de Substâncias/epidemiologiaRESUMO
The Share Project (TSP), a US health justice initiative, convened key stakeholders to advance the use of inclusive research methods and data sharing to engage groups that are typically marginalized from research. TSP trained justice-involved patients, community health workers, policymakers, and researchers in participatory research and the use of a data-sharing platform developed with justice-involved patients. The platform allowed users to analyze health and criminal justice data to develop new research that is patient driven and responsive to the needs of providers.
Assuntos
Fortalecimento Institucional , Pesquisa Participativa Baseada na Comunidade , Atenção à Saúde/organização & administração , Prisioneiros/psicologia , Humanos , Disseminação de Informação , Formulação de PolíticasRESUMO
OBJECTIVES: To evaluate the association of state dense breast notification (DBN) laws with use of supplemental tests and cancer diagnosis after screening mammography. METHODS: We examined screening mammograms (n = 1 441 544) performed in 2014 and 2015 among privately insured women aged 40 to 59 years living in 9 US states that enacted DBN laws in 2014 to 2015 and 25 US states with no DBN law in effect. DBN status at screening mammography was categorized as no DBN, generic DBN, and DBN that mandates notification of possible benefits of supplemental screening (DBN+SS). We used logistic regression to examine the change in rate of supplemental ultrasound, magnetic resonance imaging, breast biopsy, and breast cancer detection. RESULTS: DBN+SS laws were associated with 10.5 more ultrasounds per 1000 mammograms (95% CI = 3.0, 17.6 per 1000; P = .006) and 0.37 more breast cancers detected per 1000 mammograms (95% CI = 0.05, 0.69 per 1000; P = .02) compared with no DBN law. No significant differences were found for generic DBN laws in either ultrasound or cancer detection. CONCLUSIONS: DBN legislation is associated with increased use of ultrasound and cancer detection after implementation only when notification of the possible benefits of supplemental screening is required.
Assuntos
Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/patologia , Detecção Precoce de Câncer/estatística & dados numéricos , Mamografia/estatística & dados numéricos , Programas de Rastreamento/estatística & dados numéricos , Adulto , Densidade da Mama , Neoplasias da Mama/diagnóstico , Feminino , Humanos , Mamografia/métodos , Programas de Rastreamento/métodos , Pessoa de Meia-IdadeRESUMO
Health literacy is increasingly understood to be a mediator of chronic disease self-management and health care utilization. However, there has been very little research examining health literacy among incarcerated persons. This study aimed to describe the health literacy and relevant patient characteristics in a recently incarcerated primary care patient population in 12 communities in 6 states and Puerto Rico. Baseline data were collected from 751 individuals through the national Transitions Clinic Network (TCN), a model which utilizes a community health worker (CHW) with a previous history of incarceration to engage previously incarcerated people with chronic medical diseases in medical care upon release. Participants in this study completed study measures during or shortly after their first medical visit in the TCN. Data included demographics, health-related survey responses, and a measure of health literacy, The Newest Vital Sign (NVS). Bivariate and linear regression models were fit to explore associations among health literacy and the time from release to first clinic appointment, number of emergency room visits before first clinic appointment and confidence in adhering to medication. Our study found that almost 60% of the sample had inadequate health literacy. Inadequate health literacy was associated with decreased confidence in taking medications following release and an increased likelihood of visiting the emergency department prior to primary care. Early engagement may improve health risks for this population of individuals that is at high risk of death, acute care utilization, and hospitalization following release.
Assuntos
Letramento em Saúde/estatística & dados numéricos , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Prisioneiros/psicologia , Prisioneiros/estatística & dados numéricos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Porto RicoRESUMO
This study assessed the relationship between solitary confinement and post-traumatic stress disorder (PTSD) symptoms in a cohort of recently released former prisoners. The cross-sectional design utilized baseline data from the Transitions Clinic Network, a multi-site prospective longitudinal cohort study of post-incarceration medical care. Our main independent variable was self-reported solitary confinement during the participants' most recent incarceration; the dependent variable was the presence of PTSD symptoms determined by primary care (PC)-PTSD screening when participants initiated primary care in the community. We used multivariable logistic regression to adjust for potential confounders, such as prior mental health conditions, age, and gender. Among 119 participants, 43% had a history of solitary confinement and 28% screened positive for PTSD symptoms. Those who reported a history of solitary confinement were more likely to report PTSD symptoms than those without solitary confinement (43 vs. 16%, p < 0.01). In multivariable logistic regression, a history of solitary confinement (OR = 3.93, 95% CI 1.57-9.83) and chronic mental health conditions (OR = 4.04, 95% CI 1.52-10.68) were significantly associated with a positive PTSD screen after adjustment for the potential confounders. Experiencing solitary confinement was significantly associated with PTSD symptoms among individuals accessing primary care following release from prison. Larger studies should confirm these findings.
Assuntos
Espaços Confinados , Prisioneiros/psicologia , Prisioneiros/estatística & dados numéricos , Transtornos de Estresse Pós-Traumáticos/diagnóstico , Transtornos de Estresse Pós-Traumáticos/etiologia , Transtornos de Estresse Pós-Traumáticos/psicologia , Adulto , Estudos de Coortes , Estudos Transversais , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
Background: Racial disparities have been reported in breast cancer care, yet little is known about disparities in access to gene expression profiling (GEP) tests. Given the impact of GEP test results, such as those of Oncotype DX (ODx), on treatment decision-making for hormone receptor-positive (HR+) breast cancer, it is particularly important to assess disparities in its use. Methods: We conducted a retrospective population-based study of 8,784 patients diagnosed with breast cancer in Connecticut during 2011 through 2013. We assessed the association between race, ethnicity, and ODx receipt among women with HR+ breast cancer for whom NCCN does and does not recommend ODx testing, using bivariate and multivariate logistic analyses. Results: We identified 5,294 women who met study inclusion criteria: 83.8% were white, 6.3% black, and 7.4% Hispanic. Overall, 50.9% (n=4,131) of women in the guideline-recommended group received ODx testing compared with 18.5% (n=1,163) in the nonrecommended group. More white women received the ODx test compared with black and Hispanic women in the recommended and nonrecommended groups (51.4% vs 44.6% and 47.7%; and 21.2% vs 9.0% and 9.7%, respectively). After adjusting for tumor and clinical characteristics, we observed significantly lower ODx use among black (odds ratio [OR], 0.64; 95% CI, 0.47-0.88) and Hispanic women (OR, 0.59; 95% CI, 0.45-0.77) compared with white women in the recommended group and in the guideline-discordant group (blacks: OR, 0.39; 95% CI, 0.20-0.78, and Hispanics: OR, 0.44; 95% CI, 0.23-0.85). Conclusions: In this population-based study, we identified racial disparities in ODx testing. Disparities in access to innovative cancer care technologies may further exacerbate existing disparities in breast cancer outcomes.
Assuntos
Neoplasias da Mama/diagnóstico , Neoplasias da Mama/epidemiologia , Acessibilidade aos Serviços de Saúde , Disparidades em Assistência à Saúde/etnologia , Disparidades em Assistência à Saúde/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores Tumorais , Neoplasias da Mama/genética , Connecticut/epidemiologia , Connecticut/etnologia , Feminino , Perfilação da Expressão Gênica/métodos , Testes Genéticos/métodos , Humanos , Metástase Linfática , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Razão de Chances , Avaliação de Resultados da Assistência ao Paciente , Vigilância da População , Sistema de Registros , Estudos Retrospectivos , Fatores Socioeconômicos , Adulto JovemRESUMO
IMPORTANCE: Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. OBJECTIVES: To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. DESIGN AND SETTING: Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. EXPOSURES: Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approval, and regulatory review time. MAIN OUTCOMES AND MEASURES: A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. RESULTS: From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near-regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02). CONCLUSIONS AND RELEVANCE: Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near-regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.
Assuntos
Produtos Biológicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Vigilância de Produtos Comercializados , Segurança , Estudos de Coortes , Aprovação de Drogas , Humanos , Risco , Estados Unidos , United States Food and Drug AdministrationRESUMO
BACKGROUND: The upcoming reauthorization of the Prescription Drug User Fee Act focuses on improving the review process for new drug applications at the Food and Drug Administration (FDA). METHODS: Using publicly available information from the FDA, the European Medicines Agency (EMA), and Health Canada, we compared the time for completion of the first review and the total review time for all applications involving novel therapeutic agents approved by the three regulatory agencies from 2001 through 2010 and determined the geographic area in which each novel therapeutic agent was first approved for use. RESULTS: There were 510 applications for novel therapeutic agents approved from 2001 through 2010--225 by the FDA, 186 by the EMA, and 99 by Health Canada; among the applications, there were 289 unique agents. The median length of time for completion of the first review was 303 days (interquartile range, 185 to 372) for applications approved by the FDA, 366 days (interquartile range, 310 to 445) for those approved by the EMA, and 352 days (interquartile range, 255 to 420) for those approved by Health Canada (P<0.001 for the comparison across the three agencies). The median total review time was also shorter at the FDA than at the EMA or Health Canada (P=0.002). Among the 289 unique novel therapeutic agents, 190 were approved in both the United States and Europe (either by the EMA or through the mutual recognition process), of which 121 (63.7%) were first approved in the United States; similarly, 154 were approved in both the United States and Canada, of which 132 (85.7%) were first approved in the United States. CONCLUSIONS: For novel therapeutic agents approved between 2001 and 2010, the FDA reviewed applications involving novel therapeutics more quickly, on average, than did the EMA or Health Canada, and the vast majority of these new therapeutic agents were first approved for use in the United States. (Funded by the Pew Charitable Trusts.).
Assuntos
Aprovação de Drogas/organização & administração , Indústria Farmacêutica/economia , Regulamentação Governamental , Medicamentos sob Prescrição , United States Food and Drug Administration , Canadá , Comércio , Aprovação de Drogas/economia , Europa (Continente) , Honorários e Preços , Órgãos Governamentais , Humanos , Medicamentos sob Prescrição/economia , Fatores de Tempo , Estados UnidosRESUMO
BACKGROUND: Physicians often select clinical management strategies not strongly supported by evidence or guidelines. Our objective was to examine the likelihood of selecting, and rationale for pursuing, clinical management strategies with more or less guideline support among physicians using clinical vignettes of eight common medical admissions. METHODS: We conducted a cross-sectional survey using clinical vignettes of attending physicians and housestaff at one internal medicine program in New York City. Each clinical vignette included a brief clinical scenario and a varying number of clinical management strategies: diagnostic tests, consultations, and treatments, some of which had strong evidence or guideline support (Level 1 strategies) while others had limited evidence or guideline support (Level 3 strategies). Likelihood of selecting a given management strategy was assessed using Likert scales and multiple response options were used to indicate rationale(s) for selections. RESULTS: Our sample included 79 physicians; 68 (86%) were younger than 40 years of age, 34 (43%) were female. There were 31 attending physicians (39%) and 48 housestaff (61%) and 39 (49%) had or planned to have primarily primary care internal medicine clinical responsibilities. Overall, physicians were more likely to select Level 1 strategies "always" or "most of the time" when compared with Level 3 strategies (82% vs. 43%; p < 0.001), with wide variation across the eight medical admissions. There were no differences between attending and housestaff physician likelihood of selecting Level 3 strategies (47% vs. 45%, p = 0.36). Supportive evidence and local practice patterns were the two most common rationales behind selections; supportive evidence was cited as the most common rationale for selecting Level 1 when compared with Level 3 strategies (63% versus 30%; p < 0.001), whereas ruling out other severe conditions was cited most often for Level 3 strategies. CONCLUSIONS: For eight common medical admissions, physicians selected more than 80% of management strategies with strong evidence or guideline support, but also selected more than 40% of strategies for which there was limited evidence or guideline support. The promotion of evidence-based care, including the avoidance of care that is not strongly supported by evidence or guidelines, may require better evidence dissemination and educational outreach to physicians.
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Tomada de Decisões , Fidelidade a Diretrizes/estatística & dados numéricos , Medicina Interna , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Estudos Transversais , Medicina Baseada em Evidências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque , Inquéritos e QuestionáriosRESUMO
IMPORTANCE: Many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood; however, the strength of the clinical trial evidence supporting approval decisions by the US Food and Drug Administration (FDA) has not been evaluated. OBJECTIVES: To characterize pivotal efficacy trials (clinical trials that serve as the basis of FDA approval) for newly approved novel therapeutic agents. DESIGN AND SETTING: Cross-sectional analysis using publicly available FDA documents for all novel therapeutic agents approved between 2005 and 2012. MAIN OUTCOMES AND MEASURES: Pivotal efficacy trials were classified according to the following design features: randomization, blinding, comparator, and trial end point. Surrogate outcomes were defined as any end point using a biomarker expected to predict clinical benefit. The number of patients, trial duration, and trial completion rates were also determined. RESULTS: Between 2005 and 2012, the FDA approved 188 novel therapeutic agents for 206 indications on the basis of 448 pivotal efficacy trials. The median number of pivotal trials per indication was 2 (interquartile range, 1-2.5), although 74 indications (36.8%) were approved on the basis of a single pivotal trial. Nearly all trials were randomized (89.3% [95% CI, 86.4%-92.2%]), double-blinded (79.5% [95% CI, 75.7%-83.2%]), and used either an active or placebo comparator (87.1% [95% CI, 83.9%-90.2%]). The median number of patients enrolled per indication among all pivotal trials was 760 (interquartile range, 270-1550). At least 1 pivotal trial with a duration of 6 months or greater supported the approval of 68 indications (33.8% [95% CI, 27.2%-40.4%]). Pivotal trials using surrogate end points as their primary outcome formed the exclusive basis of approval for 91 indications (45.3% [95% CI, 38.3%-52.2%]), clinical outcomes for 67 (33.3% [95% CI, 26.8%-39.9%]), and clinical scales for 36 (17.9% [95% CI, 12.6%-23.3%]). Trial features differed by therapeutic and indication characteristics, such as therapeutic area, expected length of treatment, orphan status, and accelerated approval. CONCLUSIONS AND RELEVANCE: The quality of clinical trial evidence used by the FDA as the basis for recent approvals of novel therapeutic agents varied widely across indications. This variation has important implications for patients and physicians as they make decisions about the use of newly approved therapeutic agents.
Assuntos
Aprovação de Drogas , Ensaios Clínicos Controlados Aleatórios como Assunto , United States Food and Drug Administration , Biomarcadores , Estudos Transversais , Tomada de Decisões , Determinação de Ponto Final , Preparações Farmacêuticas , Projetos de Pesquisa , Estados UnidosRESUMO
Although incarcerated adults are at elevated risk of dying from cancer, little is known about cancer screening in carceral settings. This study compared stage-specific incidence of screen-detectable cancers among incarcerated and recently released people with the general population, as a reflection of screening practices. We calculated the age- and sex-standardized incidence ratios (SIR) for early- and late-stage cancers for incarcerated and recently released adults compared to the general Connecticut population between 2005 and 2016. Our sample included 143 cancer cases among those incarcerated, 406 among those recently released, and 201â360 in the general population. The SIR for early-stage screen-detectable cancers was lower among incarcerated (SIR = 0.28, 95% CI = 0.17 to 0.43) and recently released (SIR = 0.69, 95% CI = 0.51 to 0.88) individuals than the general population. Incidence of late-stage screen-detectable cancer was lower during incarceration (SIR = 0.51, 95% CI = 0.27 to 0.88) but not after release (SIR = 1.32, 95% CI = 0.93 to 1.82). Findings suggest that underscreening and underdetection of cancer may occur in carceral settings.
Assuntos
Encarceramento , Neoplasias , Adulto , Humanos , Connecticut/epidemiologia , Neoplasias/diagnóstico , Neoplasias/epidemiologia , Incidência , Fatores de RiscoRESUMO
BACKGROUND: Incarceration is a social determinant of cardiovascular health but is rarely addressed in clinical settings or public health prevention efforts. People who have been incarcerated are more likely to develop cardiovascular disease (CVD) at younger ages and have worse cardiovascular outcomes compared with the general population, even after controlling for traditional risk factors. This study aims to identify incarceration-specific factors that are associated with uncontrolled CVD risk factors to identify potential targets for prevention. METHODS AND RESULTS: Using data from JUSTICE (Justice-Involved Individuals Cardiovascular Disease Epidemiology), a prospective cohort study of individuals released from incarceration with CVD risk factors, we examine the unique association between incarceration-specific factors and CVD risk factor control. Participants (N=471), with a mean age of 45.0±10.8 (SD) years, were disproportionately from racially minoritized groups (79%), and poor (91%). Over half (54%) had at least 1 uncontrolled CVD risk factor at baseline. People released from jail, compared with prison, had lower Life's Essential 8 scores for blood pressure and smoking. Release from jail, as compared with prison, was associated with an increased odds of having an uncontrolled CVD risk factor, even after adjusting for age, race and ethnicity, gender, perceived stress, and life adversity score (adjusted odds ratio 1.62 [95% CI, 1.02-2.57]). DISCUSSION: Release from jail is associated with poor CVD risk factor control and requires tailored intervention, which is informative as states design and implement the Centers of Medicare & Medicaid Services Reentry 1115 waiver, which allows Medicaid to cover services before release from correctional facilities.
Assuntos
Doenças Cardiovasculares , Fatores de Risco de Doenças Cardíacas , Prisioneiros , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Prisioneiros/estatística & dados numéricos , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Estudos Transversais , Adulto , Estudos Prospectivos , Prisões , Determinantes Sociais da Saúde , Estados Unidos/epidemiologia , Fatores de Risco , Medição de Risco , Fumar/epidemiologia , Fumar/efeitos adversosRESUMO
OBJECTIVE: Posttraumatic stress disorder (PTSD) is prevalent among people who have been incarcerated. Here, we examined whether screening positive for PTSD was associated with other indicators of poor health, acute healthcare utilization, and poverty among primary care patients upon release from incarceration. METHOD: We conducted a cross-sectional survey in a national network of primary care clinics serving people recently released from incarceration. Participants were 416 patients who completed the Primary Care PTSD screen (PC-PTSD) and other questions about mental and physical health, acute healthcare utilization, and economic status within 6 months of release. RESULTS: Screening positive for PTSD was associated with worse status across nearly all variables examined, including being more likely to report: poor/fair health (61.6% vs. 41.7%), current depressive symptoms (89.7% vs. 50.8%), lifetime depression diagnosis (63.3% vs. 35.3%), cannabis use since release (20.7% vs. 9.6%), homelessness (31.9% vs. 18.5%), having no cash on hand (56.3% vs. 39.0%) and severe food insecurity (29.3% vs. 18.2%; all ps < .01). Reporting recent suicidality (14.3% vs. 7.0%), alcohol use since release (30.2% vs. 20.0%), and emergency department utilization (20.4% vs. 12.2%) was also more likely (all ps ≤ .03). These trends were largely upheld when controlling for demographic characteristics and chronic physical health conditions using linear probability regression. CONCLUSIONS: Primary care patients recently released from incarceration have a need for wrap-around services that address health challenges and poverty. Patients with significant PTSD symptoms face even greater challenges. Identification and treatment of PTSD both during and after incarceration is warranted. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
RESUMO
Delays in vaccinating communities of color to COVID-19 have signaled a need to investigate structural barriers to vaccine uptake, with mass incarceration demanding greater characterization as a potential factor. In a nationally representative survey from February-March 2021 (N = 1,157), exposure to the criminal legal system, defined as having been incarcerated in prison or jail or having had a family member or close friend incarcerated, was associated with higher odds for COVID-19 vaccine deliberation. Individuals with criminal legal system exposure reported lower confidence in physician recommendation as a reason to get vaccinated. They were also more likely to decline vaccination out of fear it would cause COVID-19 infection, and that the vaccine might be promoted as a political tool. Our analysis suggests that populations impacted by the criminal legal system would benefit from targeted vaccine outreach by trusted community members who can address distrust during current and future pandemics.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , COVID-19/prevenção & controle , Inquéritos e Questionários , VacinaçãoRESUMO
BACKGROUND: Cancer incidence among individuals with incarceration exposure has been rarely studied due to the absence of linked datasets. This study examined cancer incidence during incarceration and postincarceration compared to the general population using a statewide linked cohort. METHODS: We constructed a retrospective cohort from a linkage of state tumor registry and correctional system data for Connecticut residents from 2005 to 2016, and identified cancers diagnosed during and within 12 months postincarceration. We estimated incidence rates (including for screen-detectable cancers) and calculated the standardized incidence ratios (SIR) for the incarcerated and recently released populations, relative to the general population. We also examined cancer incidence by race and ethnicity within each group. RESULTS: Cancer incidence was lower in incarcerated individuals (SIR = 0.64, 95% CI 0.56-0.72), but higher in recently released individuals (SIR = 1.34, 95% CI 1.23-1.47) compared with the general population, and across all race and ethnic strata. Similarly, nonscreen-detectable cancer incidence was lower in incarcerated and higher in recently released populations compared to the general population. However, non-Hispanic Black individuals had elevated incidence of screen-detectable cancers compared with non-Hispanic White individuals across all three populations (incarcerated, SIR = 1.66, 95% CI 1.03-2.53; recently released, SIR = 1.83, 95% CI 1.32-2.47; and general population, SIR = 1.18, 95% CI 1.16-1.21). CONCLUSION: Compared with the general population, incarcerated persons have a lower cancer incidence, whereas recently released persons have a higher cancer incidence. Irrespective of incarceration status, non-Hispanic Black individuals have a higher incidence of screen-detectable cancers compared with non-Hispanic White individuals. Supplemental studies examining cancer screening and diagnoses during incarceration are needed to discern the reasons for observed disparities in incidence.
Assuntos
Neoplasias , Prisioneiros , Humanos , Estudos Retrospectivos , Incidência , Neoplasias/epidemiologia , EtnicidadeRESUMO
BACKGROUND: The complex relationship between incarceration and cancer survival has not been thoroughly evaluated. We assessed whether cancer diagnosis during incarceration or the immediate post-release period is associated with higher rates of mortality compared with those never incarcerated. METHODS: We conducted a population-based study using a statewide linkage of tumor registry and correctional system movement data for Connecticut adult residents diagnosed with invasive cancer from 2005 through 2016. The independent variable was place of cancer diagnosis: during incarceration, within 12 months post-release, and never incarcerated. The dependent variables were five-year cancer-related and overall survival rates. RESULTS: Of the 216,540 adults diagnosed with invasive cancer during the study period, 239 (0.11%) people were diagnosed during incarceration, 479 (0.22%) within 12 months following release, and the remaining were never incarcerated. After accounting for demographics and cancer characteristics, including stage of diagnosis, the risk for cancer-related death at five years was significantly higher among those diagnosed while incarcerated (AHR = 1.39, 95% CI = 1.12-1.73) and those recently released (AHR = 1.82, 95% CI = 1.57-2.10) compared to the never-incarcerated group. The risk for all-cause mortality was also higher for those diagnosed with cancer while incarcerated (AHR = 1.92, 95% CI = 1.63-2.26) and those recently released (AHR = 2.18, 95% CI = 1.94-2.45). CONCLUSIONS AND RELEVANCE: There is a higher risk of cancer mortality among individuals diagnosed with cancer during incarceration and in the first-year post-release, which is not fully explained by stage of diagnosis. Cancer prevention and treatment efforts should target people who experience incarceration and identify why incarceration is associated with worse outcomes.