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1.
Am J Hematol ; 98(8): 1176-1184, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37139921

RESUMO

Approximately 5% to 15% of acute myeloid leukemia (AML) patients have TP53 gene mutations (TP53m), which are associated with very poor outcomes. Adults (≥18 years) with a new AML diagnosis were included from a nationwide, de-identified, real-world database. Patients receiving first-line therapy were divided into three cohorts: venetoclax (VEN) + hypomethylating agents (HMAs; Cohort A), intensive chemotherapy (Cohort B), or HMA without VEN (Cohort C). A total of 370 newly diagnosed AML patients with TP53m (n = 124), chromosome 17p deletion (n = 166), or both (n = 80) were included. The median age was 72 years (range, 24-84); most were male (59%) and White (69%). Baseline bone marrow (BM) blasts were ≤30%, 31%-50%, and >50% in 41%, 24%, and 29% of patients in Cohorts A, B, and C, respectively. BM remission (<5% blasts) with first-line therapy was reported in 54% of patients (115/215) overall, and 67% (38/57), 62% (68/110), and 19% (9/48) for respective cohorts (median BM remission duration: 6.3, 6.9, and 5.4 months). Median overall survival (95% CI) was 7.4 months (6.0-8.8) for Cohort A, 9.4 months (7.2-10.4) for Cohort B, and 5.9 months (4.3-7.5) for Cohort C. There were no differences in survival by treatment type after adjusting for the effects of relevant covariates (Cohort A vs. C adjusted hazard ratio [aHR] = 0.9; 95% CI, 0.7-1.3; Cohort A vs. B aHR = 1.0; 95% CI, 0.7-1.5; and Cohort C vs. B aHR = 1.1; 95% CI, 0.8-1.6). Patients with TP53m AML have dismal outcomes with current therapies, demonstrating the high unmet need for improved treatments.


Assuntos
Genes p53 , Leucemia Mieloide Aguda , Adulto , Idoso , Feminino , Humanos , Masculino , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Deleção Cromossômica , Cromossomos , Leucemia Mieloide Aguda/tratamento farmacológico , Leucemia Mieloide Aguda/genética , Mutação , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Proteína Supressora de Tumor p53/genética , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais
2.
MMWR Morb Mortal Wkly Rep ; 64(11): 305-8, 2015 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-25811680

RESUMO

These revised recommendations of the Advisory Committee on Immunization Practices update recommendations published in MMWR in 1994 and include updated information on the two currently available vaccines and on vaccine safety. They also include an update on the epidemiology of enteric fever in the United States, focusing on increasing drug resistance in Salmonella enterica serotype Typhi, the cause of typhoid fever, as well as the emergence of Salmonella serotype Paratyphi A, a cause of paratyphoid fever, against which typhoid vaccines offer little or no protection.


Assuntos
Febre Tifoide/prevenção & controle , Vacinas Tíficas-Paratíficas/administração & dosagem , Comitês Consultivos , Humanos , Esquemas de Imunização , Guias de Prática Clínica como Assunto , Febre Tifoide/epidemiologia , Vacinas Tíficas-Paratíficas/efeitos adversos , Estados Unidos/epidemiologia
3.
Clin Infect Dis ; 58(8): 1149-55, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24415636

RESUMO

Guillain-Barré syndrome (GBS) is the most common cause of acute flaccid paralysis worldwide, and is thought to be immune-mediated. It is preceded by upper respiratory or gastrointestinal infection in about two-thirds of cases and is associated with some viral infections, including influenza. GBS has also been associated with the 1976 swine-influenza vaccine. Thereafter, some studies have shown a small increased risk of GBS following receipt of seasonal and 2009 H1N1 monovalent influenza vaccines. Studies over the years have also shown an increased risk of GBS following influenza infection, and the magnitude of risk is several times greater than that following influenza vaccination. Because GBS is rare, and even rarer following vaccination, it is difficult to estimate precise risk. We try to shed light on the complex relationship of GBS and its association with influenza and influenza vaccines over the past 35 years.


Assuntos
Síndrome de Guillain-Barré/induzido quimicamente , Síndrome de Guillain-Barré/epidemiologia , Vacinas contra Influenza/efeitos adversos , Influenza Humana/complicações , Vacinação/efeitos adversos , Humanos , Incidência , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Vacinação/estatística & dados numéricos
4.
Am J Public Health ; 104(4): 696-701, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24524517

RESUMO

OBJECTIVES: We sought to assess risk of Guillain-Barré syndrome (GBS) among influenza A (H1N1) 2009 monovalent (pH1N1) vaccinated and unvaccinated populations at the end of the 2009 pandemic. METHODS: We applied GBS surveillance data from a US population catchment area of 45 million from October 15, 2009, through May 31, 2010. GBS cases meeting Brighton Collaboration criteria were included. We calculated the incidence density ratio (IDR) among pH1N1 vaccinated and unvaccinated populations. We also estimated cumulative GBS risk using life table analysis. Additionally, we used vaccine coverage data and census population estimates to calculate denominators. RESULTS: There were 392 GBS cases; 64 (16%) occurred after pH1N1vaccination. The vaccinated population had lower average risk (IDR = 0.83, 95% confidence interval = 0.63, 1.08) and lower cumulative risk (6.6 vs 9.2 cases per million persons, P = .012) of GBS. CONCLUSIONS: Our findings suggest that at the end of the influenza season cumulative GBS risk was less among the pH1N1vaccinated than the unvaccinated population, suggesting the benefit of vaccination as it relates to GBS. The observed potential protective effect on GBS attributed to vaccination warrants further study.


Assuntos
Síndrome de Guillain-Barré/epidemiologia , Vírus da Influenza A Subtipo H1N1 , Vacinas contra Influenza/efeitos adversos , Influenza Humana/epidemiologia , Pandemias/estatística & dados numéricos , Adulto , Fatores Etários , Idoso , Feminino , Síndrome de Guillain-Barré/etiologia , Síndrome de Guillain-Barré/prevenção & controle , Humanos , Vacinas contra Influenza/uso terapêutico , Influenza Humana/prevenção & controle , Tábuas de Vida , Masculino , Pessoa de Meia-Idade , Pandemias/prevenção & controle , Fatores de Risco , Estados Unidos/epidemiologia , Adulto Jovem
5.
Am J Public Health ; 104 Suppl 1: S175-82, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24354818

RESUMO

OBJECTIVES: We evaluated associations between current asthma and birthplace among major racial/ethnic groups in the United States. METHODS: We used multivariate logistic regression methods to analyze data on 102,524 children and adolescents and 255,156 adults in the National Health Interview Survey (2001-2009). RESULTS: We found significantly higher prevalence (P < .05) of current asthma among children and adolescents (9.3% vs 5.1%) and adults (7.6% vs 4.7%) born in the 50 states and Washington, DC (US-born), than among those born elsewhere. These differences were among all age groups of non-Hispanic Whites, non-Hispanic Blacks, and Hispanics (excluding Puerto Ricans) and among Chinese adults. Non-US-born adults with 10 or more years of residency in the United States had higher odds of current asthma (odds ratio = 1.55; 95% confidence interval = 1.25, 1.93) than did those who arrived more recently. Findings suggested a similar trend among non-US-born children. CONCLUSIONS: Current asthma status was positively associated with being born in the United States and with duration of residency in the United States. Among other contributing factors, changes in environment and acculturation may explain some of the differences in asthma prevalence.


Assuntos
Aculturação , Asma/epidemiologia , Emigrantes e Imigrantes/estatística & dados numéricos , Adolescente , Adulto , Idoso , Asma/etiologia , Criança , Pré-Escolar , Meio Ambiente , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Grupos Raciais/estatística & dados numéricos , Características de Residência/estatística & dados numéricos , Estados Unidos/epidemiologia , Adulto Jovem
6.
Clin Lymphoma Myeloma Leuk ; 24(4): 260-268.e2, 2024 04.
Artigo em Inglês | MEDLINE | ID: mdl-38216397

RESUMO

INTRODUCTION: Azacitidine (AZA) is an approved frontline therapy for higher-risk myelodysplastic syndromes (HR-MDS); however, poor survival denotes unmet needs to increase depth/duration of response (DOR). METHODS: This retrospective study with patient chart review evaluated AZA effectiveness in 382 treatment-naive patients with HR-MDS from a US electronic health record (EHR)-derived database. Responses were assessed using International Working Group (IWG) 2006 criteria; real-world equivalents were derived from EHRs. Primary endpoint was IWG 2006-based complete remission rate (CRR). Secondary endpoints were EHR-based CRR, IWG 2006- and EHR-based objective response rates (ORRs), duration of CR, DOR, progression-free survival, time-to-next-treatment, and overall survival (OS). RESULTS: Using IWG 2006 criteria, the CRR was 7.9% (n = 30); median duration of CR was 12.0 months (95% CI, 7.7-15.6). In poor cytogenetic risk (n = 101) and TP53 mutation (n = 46) subgroups, CRRs were 7.9% (n = 8) and 8.7% (n = 4), respectively. ORR was 62.8% (n = 240), including a hematologic improvement rate (HIR) of 46.9% (n = 179). Using EHR-based data, CRR was 3.7% (n = 14); median duration of CR was 13.5 months (95% CI, 4.5-21.5). ORR was 67.8% (n = 259), including an HIR of 29.3% (n = 112). Median follow-up was 12.9 months; median OS was 17.9 months (95% CI, 15.5-21.7). CONCLUSIONS: Consistent with other studies, CRRs and median OS with AZA in treatment-naive patients with HR-MDS were low in this large, real-world cohort. Novel agents/combinations are urgently needed to improve these outcomes in HR-MDS.


Assuntos
Azacitidina , Síndromes Mielodisplásicas , Humanos , Azacitidina/farmacologia , Azacitidina/uso terapêutico , Antimetabólitos Antineoplásicos/farmacologia , Antimetabólitos Antineoplásicos/uso terapêutico , Síndromes Mielodisplásicas/genética , Estudos Retrospectivos , Mutação , Resultado do Tratamento
7.
J Asthma ; 50(5): 488-96, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23544662

RESUMO

OBJECTIVES: Racial/ethnic disparities in current asthma prevalence and medical care are a major public health concern. We examined the differences in asthma prevalence and morbidity among major racial/ethnic populations in the US. METHODS: We analyzed data from the 2001-2010 National Health Interview Survey for adults (≥18 years) and children and adolescents (<18 years). Outcome variables were current asthma prevalence, at least one attack in the past 12 months, and at least one asthma-related emergency department/urgent care center (ED/UCC) visit in the past 12 months. We used multivariate logistic regression to calculate the model-adjusted prevalence and risk ratios (ARR). RESULTS: In our study, 9.0% of the children and 7.2% of the adults had current asthma. Non-Hispanic black and Puerto Rican children were more likely to have current asthma (ARR 1.46, 1.66, respectively) and to visit the ED/UCC (ARR 1.61, 1.67, respectively) than non-Hispanic whites. American Indian/Alaskan Native children were more likely to have current asthma (ARR 1.76) than non-Hispanic whites. Mexican/Mexican American children and adults had lower prevalence of current asthma but higher ED/UCC use (adults only) than non-Hispanic whites. Among adults, Puerto Ricans and American Indian/Alaskan Natives were more likely to have current asthma (ARR 1.60, 1.39, respectively) than non-Hispanic whites, and all the studied racial/ethnic groups except Asians were more likely to have visited the ED/UCC than non-Hispanic whites. Adults and children who received emergency care for asthma in the past 12 months more frequently received multiple components of asthma management and control (e.g., taking long-term medication, having an asthma management plan) compared to those without emergency care. CONCLUSIONS: Racial/ethnic differences in current asthma prevalence, asthma attacks, and increased utilization of emergency room visits for asthma among minorities persist among children and adults. Appropriate and effective asthma management and education may lead to better asthma control and reduce emergency care utilization.


Assuntos
Asma/etnologia , Serviço Hospitalar de Emergência , Disparidades nos Níveis de Saúde , Inquéritos Epidemiológicos , Adolescente , Adulto , Idoso , Asma/terapia , Criança , Pré-Escolar , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Tempo
8.
Pharmacoepidemiol Drug Saf ; 22(12): 1263-70, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23847024

RESUMO

PURPOSE: Concerns have been raised that children may be receiving too many immunizations under the recommended schedule in the USA. We used a publicly available dataset to evaluate the association between antibody-stimulating proteins and polysaccharides from early childhood vaccines and neuropsychological outcomes at age 7-10 years. METHODS: Children aged 7-10 years from four managed care organizations underwent standardized tests for domain-specific neuropsychological outcomes: general intellectual function, speech and language, verbal memory, attention and executive function, tics, achievement, visual spatial ability, and behavior regulation. Vaccination histories up to 24 months of age were obtained from medical charts, electronic records, and parents' records. Logistic regressions and structural equation modeling (SEM) were used to determine associations between total antigens up to 7, 12, and 24 months and domain-specific outcomes. RESULTS: On average, children (N = 1047) received 7266, 8127, and 10 341 antigens by ages 7, 12, and 24 months, respectively. For adjusted analyses, increase (per 1000) in the number of antigens was not associated with any neuropsychological outcomes. Antigen counts above the 10th percentile, compared with lower counts, were also not associated with any adverse outcomes. However, children with higher antigen counts up to 24 months performed better on attention and executive function tests (odds ratio for lower scores = 0.51, 95% confidence interval = 0.26, 0.99). Similar results were found with SEM analysis (b = 0.08, p = 0.02). CONCLUSIONS: We did not find any adverse associations between antigens received through vaccines in the first two years of life and neuropsychological outcomes in later childhood. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.


Assuntos
Antígenos/análise , Esquemas de Imunização , Processos Mentais , Vacinação/normas , Vacinas/imunologia , Antígenos/imunologia , Criança , Humanos , Modelos Logísticos , Modelos Estruturais , Testes Neuropsicológicos , Vacinação/estatística & dados numéricos , Vacinas/administração & dosagem
9.
J Hematol Oncol ; 16(1): 19, 2023 03 06.
Artigo em Inglês | MEDLINE | ID: mdl-36879351

RESUMO

BACKGROUND: TP53 mutations, which are present in 5% to 10% of patients with acute myeloid leukemia (AML), are associated with treatment resistance and poor outcomes. First-line therapies for TP53-mutated (TP53m) AML consist of intensive chemotherapy (IC), hypomethylating agents (HMA), or venetoclax combined with HMA (VEN + HMA). METHODS: We conducted a systematic review and meta-analysis to describe and compare treatment outcomes in newly diagnosed treatment-naïve patients with TP53m AML. Randomized controlled trials, single-arm trials, prospective observational studies, and retrospective studies were included that reported on complete remission (CR), CR with incomplete hematologic recovery (CRi), overall survival (OS), event-free survival (EFS), duration of response (DoR), and overall response rate (ORR) among patients with TP53m AML receiving first-line treatment with IC, HMA, or VEN + HMA. RESULTS: Searches of EMBASE and MEDLINE identified 3006 abstracts, and 17 publications describing 12 studies met the inclusion criteria. Random-effects models were used to pool response rates, and time-related outcomes were analyzed with the median of medians method. IC was associated with the greatest CR rate of 43%, and CR rates were 33% for VEN + HMA and 13% for HMA. Rates of CR/CRi were comparable for IC (46%) and VEN + HMA (49%) but were lower for HMA (13%). Median OS was uniformly poor across treatments: IC, 6.5 months; VEN + HMA, 6.2 months; and HMA, 6.1 months. For IC, the EFS estimate was 3.7 months; EFS was not reported for VEN + HMA or HMA. The ORR was 41% for IC, 65% for VEN + HMA, and 47% for HMA. DoR was 3.5 months for IC, 5.0 months for VEN + HMA, and was not reported for HMA. CONCLUSIONS: Despite improved responses seen with IC and VEN + HMA compared to HMA, survival was uniformly poor, and clinical benefits were limited across all treatments for patients with newly diagnosed, treatment-naïve TP53m AML, demonstrating a significant need for improved treatment for this difficult-to-treat population.


Assuntos
Leucemia Mieloide Aguda , Humanos , Estudos Retrospectivos , Resultado do Tratamento , Leucemia Mieloide Aguda/tratamento farmacológico , Leucemia Mieloide Aguda/genética , Intervalo Livre de Progressão , Mutação , Proteína Supressora de Tumor p53/genética , Estudos Observacionais como Assunto
10.
Clin Pharmacol Ther ; 114(4): 751-767, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37393555

RESUMO

Since the 21st Century Cures Act was signed into law in 2016, real-world data (RWD) and real-world evidence (RWE) have attracted great interest from the healthcare ecosystem globally. The potential and capability of RWD/RWE to inform regulatory decisions and clinical drug development have been extensively reviewed and discussed in the literature. However, a comprehensive review of current applications of RWD/RWE in clinical pharmacology, particularly from an industry perspective, is needed to inspire new insights and identify potential future opportunities for clinical pharmacologists to utilize RWD/RWE to address key drug development questions. In this paper, we review the RWD/RWE applications relevant to clinical pharmacology based on recent publications from member companies in the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) RWD Working Group, and discuss the future direction of RWE utilization from a clinical pharmacology perspective. A comprehensive review of RWD/RWE use cases is provided and discussed in the following categories of application: drug-drug interaction assessments, dose recommendation for patients with organ impairment, pediatric plan development and study design, model-informed drug development (e.g., disease progression modeling), prognostic and predictive biomarkers/factors identification, regulatory decisions support (e.g., label expansion), and synthetic/external control generation for rare diseases. Additionally, we describe and discuss common sources of RWD to help guide appropriate data selection to address questions pertaining to clinical pharmacology in drug development and regulatory decision making.


Assuntos
Ecossistema , Farmacologia Clínica , Humanos , Criança , Desenvolvimento de Medicamentos , Atenção à Saúde
11.
Clin Lymphoma Myeloma Leuk ; 23(2): 127-137, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36428152

RESUMO

BACKGROUND: The global incidence of myelodysplastic syndromes (MDS) has been estimated as 0.06 to 0.26/100,000. Since their introduction, hypomethylating agents have played a central role in the treatment of MDS, with heterogeneous real-world outcomes. MATERIALS AND METHODS: We assessed and synthesized clinical outcomes of azacitidine (AZA) monotherapy in treatment-naïve patients with higher-risk MDS. A systematic literature review was conducted by searching MEDLINE, Embase, and CENTRAL to identify randomized clinical trials (RCTs) and observational studies, both prospective and retrospective, reporting complete remission (CR), partial remission (PR), overall survival (OS), duration of response (DOR), time-to-response (TTR), and myelosuppressive adverse events (AEs) for patients treated with AZA monotherapy. Noncomparative meta-analyses were used to summarize effects. RESULTS: The search identified 3250 abstracts, of which 34 publications describing 16 studies (5 RCTs, 3 prospective, and 8 retrospective observational) were included. Across all studies, pooled CR was 16%; PR was 6%; Median OS was 16.4 months; median DOR was 10.1 months; median TTR was 4.6 months. Proportions of grade 3/4 anemia and thrombocytopenia AEs were 10% and 30%. CONCLUSIONS: The effectiveness and efficacy of AZA monotherapy-as measured by CR and median OS-was limited. These findings highlight a significant unmet medical need for effective treatments for patients with higher-risk MDS.


Assuntos
Azacitidina , Síndromes Mielodisplásicas , Humanos , Azacitidina/efeitos adversos , Antimetabólitos Antineoplásicos/efeitos adversos , Síndromes Mielodisplásicas/tratamento farmacológico , Resultado do Tratamento , Indução de Remissão
12.
Am J Public Health ; 102(10): 1957-63, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22897556

RESUMO

OBJECTIVES: We conducted a systematic literature review to better understand aspects of disaster-related carbon monoxide (CO) poisoning surveillance and determine potentially effective prevention strategies. METHODS: This review included information from 28 journal articles on disaster-related CO poisoning cases occurring between 1991 and 2009 in the United States. RESULTS: We identified 362 incidents and 1888 disaster-related CO poisoning cases, including 75 fatalities. Fatalities occurred primarily among persons who were aged 18 years or older (88%) and male (79%). Hispanics and Asians accounted for 20% and 14% of fatal cases and 21% and 7% of nonfatal cases, respectively. Generators were the primary exposure source for 83% of fatal and 54% of nonfatal cases; 67% of these fatal cases were caused by indoor generator placement. Charcoal grills were a major source of exposure during winter storms. Most fatalities (94%) occurred at home. Nearly 89% of fatal and 53% of nonfatal cases occurred within 3 days of disaster onset. CONCLUSIONS: Public health prevention efforts could benefit from emphasizing predisaster risk communication and tailoring interventions for racial, ethnic, and linguistic minorities. These findings highlight the need for surveillance and CO-related information as components of disaster preparedness, response, and prevention.


Assuntos
Intoxicação por Monóxido de Carbono/epidemiologia , Intoxicação por Monóxido de Carbono/prevenção & controle , Adolescente , Adulto , Intoxicação por Monóxido de Carbono/etiologia , Intoxicação por Monóxido de Carbono/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Adulto Jovem
13.
Am J Emerg Med ; 30(6): 846-51, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-21855265

RESUMO

BACKGROUND: Unintentional carbon monoxide poisoning is preventable. Severe cases are often referred for hyperbaric oxygen treatment. To guide prevention efforts and treatment practices, this study provides some of the most detailed current information about patients with carbon monoxide poisoning who have been treated at hyperbaric facilities across the United States and the circumstances surrounding their exposures. This study can help improve efforts to prevent carbon monoxide poisoning and enhance treatment practices. METHODS: From August 2008 to January 2010, nonidentifiable, patient-level data were reported by 87 hyperbaric facilities in 39 states via an online reporting system. This reporting system was developed collaboratively by the Undersea and Hyperbaric Medical Society and the Centers for Disease Control and Prevention. RESULTS: Among the 864 patients reported to receive hyperbaric oxygen treatment for unintentional, non-fire-related, carbon monoxide poisoning, most of the patients were white men aged between 18 and 44 years. Only 10% of patients reported the presence of a carbon monoxide alarm at their exposure location, and 75% reported being part of a group exposure. Nineteen patients (2%) reported a prior carbon monoxide exposure. About half (55%) of the patients treated were discharged after treatment; 41% were hospitalized. CONCLUSIONS: The findings in this report expand the knowledge about patients with carbon monoxide poisoning. These results suggest that prevention efforts, such as educating the public about using carbon monoxide alarms and targeting the most at-risk populations, may help reduce the number of exposures, the number of persons with chronic cognitive sequelae, and the resulting burden on the health care system.


Assuntos
Intoxicação por Monóxido de Carbono/terapia , Oxigenoterapia Hiperbárica/estatística & dados numéricos , Adolescente , Adulto , Fatores Etários , Idoso , Intoxicação por Monóxido de Carbono/epidemiologia , Intoxicação por Monóxido de Carbono/etiologia , Intoxicação por Monóxido de Carbono/prevenção & controle , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Estados Unidos/epidemiologia , Adulto Jovem
14.
Am J Emerg Med ; 30(5): 657-64, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21570230

RESUMO

BACKGROUND: Unintentional, non-fire-related (UNFR) carbon monoxide (CO) poisoning is a leading cause of poisoning in the United States, but the overall hospital burden is unknown. This study presents patient characteristics and the most recent comprehensive national estimates of UNFR CO-related emergency department (ED) visits and hospitalizations. METHODS: Data from the 2007 Nationwide Inpatient and Emergency Department Sample of the Hospitalization Cost and Utilization Project were analyzed. The Council of State and Territorial Epidemiologists' CO poisoning case definition was used to classify confirmed, probable, and suspected cases. RESULTS: In 2007, more than 230,000 ED visits (772 visits/million) and more than 22,000 hospitalizations (75 stays/million) were related to UNFR CO poisoning. Of these, 21,304 ED visits (71 visits/million) and 2302 hospitalizations (8 stays/million) were confirmed cases of UNFR CO poisoning. Among the confirmed cases, the highest ED visit rates were among persons aged 0 to 17 years (76 visits/million) and 18 to 44 years (87 visits/million); the highest hospitalization rate was among persons aged 85 years or older (18 stays/million). Women visited EDs more frequently than men, but men were more likely to be hospitalized. Patients residing in a nonmetropolitan area and in the northeast and midwest regions of the country had higher ED visit and hospitalization rates. Carbon monoxide exposures occurred mostly (>60%) at home. The hospitalization cost for confirmed CO poisonings was more than $26 million. CONCLUSION: Unintentional, non-fire-related CO poisonings pose significant economic and health burden; continuous monitoring and surveillance of CO poisoning are needed to guide prevention efforts. Public health programs should emphasize CO alarm use at home as the main prevention strategy.


Assuntos
Intoxicação por Monóxido de Carbono/epidemiologia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Intoxicação por Monóxido de Carbono/economia , Criança , Pré-Escolar , Efeitos Psicossociais da Doença , Feminino , Custos Hospitalares/estatística & dados numéricos , Humanos , Lactente , Recém-Nascido , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estações do Ano , Estados Unidos/epidemiologia , Adulto Jovem
15.
J Public Health Manag Pract ; 18(3): 272-8, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22473121

RESUMO

OBJECTIVE: Unintentional carbon monoxide (CO) poisoning is a leading cause of poisoning in the United States. Most poisoning cases occur in residential settings and a working CO alarm may prevent many of these events. The use of a CO alarm is mandated in many parts of the country; however, little is known about the compliance and adoption of such ordinances at the population level. This study determined the prevalence of residential CO alarm and awareness of a 2001 CO alarm ordinance in Mecklenburg County, North Carolina in 2009. METHODS: A random sample of households stratified by housing type (eg, single-family homes, multifamily homes) was included in a cross-sectional survey conducted. One adult respondent from each household was administered a questionnaire that included information on sociodemographic and household characteristics, presence of a CO alarm, and CO alarm ordinance awareness. Data were analyzed using multivariate stratified conditional logistic regression. RESULTS: Among 214 participating households (response rate, 23.4%), 145 (67.8%) reported having a working CO alarm and 79 (36.9%) of the respondents were aware of the CO alarm ordinance. Respondents who were aware of the ordinance had 9 times higher odds (95% confidence interval, 3.3-25.9) of having a CO alarm than those who were unaware. Also, households with an attached garage had more than 2 times higher odds (95% confidence interval, 1.0-6.2) of having a CO alarm than those without an attached garage. Awareness of the CO alarm ordinance was not associated with any sociodemographic (eg, age, sex, race, education, income) or household (eg, home ownership, home construction year) characteristics. CONCLUSIONS: Carbon monoxide alarm prevalence in Mecklenburg County households was higher than the national average and was associated with CO alarm ordinance awareness. Public health efforts might benefit from regulations aimed at population-level adoption of preventive health behaviors.


Assuntos
Poluição do Ar em Ambientes Fechados/análise , Monóxido de Carbono/análise , Monitoramento Ambiental/instrumentação , Fidelidade a Diretrizes , Adulto , Idoso , Idoso de 80 Anos ou mais , Intoxicação por Monóxido de Carbono/prevenção & controle , Estudos Transversais , Coleta de Dados , Feminino , Habitação , Humanos , Masculino , Pessoa de Meia-Idade , North Carolina , Adulto Jovem
16.
Clin Transl Sci ; 15(10): 2293-2302, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35912537

RESUMO

Pharmaceutical products in the current accelerated drug development landscape can benefit from tools beyond data generated from randomized control trials. We have seen an abundance of real-world data (RWD) and real-world evidence, driven by the digitalization of healthcare systems and an increased awareness that has inspired a heightened interest in their potential use. Literature review suggest leveraging RWD as a promising tool to answer key questions in the areas of clinical pharmacology and translational science. RWD may increase our understanding regarding the impact of intrinsic (e.g., liver, renal impairment, or genetic polymorphisms) and extrinsic (e.g., food consumption or concomitant medications) factors on the clearance of administered drugs. Changes in clearance may lead to clinically relevant changes in drug exposure that may require clinical management strategies, such as change in dose or dosing regimen. RWD can be leveraged to potentially bridge the gaps among research, development, and clinical care. This paper highlights promising areas of how RWD have been used to complement clinical pharmacology throughout various phases of drug development; case examples will include dose/regimen extrapolation, dose adjustments for special populations (organ impairment, pediatrics, etc.), and pharmacokinetic/pharmacodynamic models to assess impact of prognostic factors on outcomes. In addition, this paper will also juxtapose limitations and promises of utilizing RWD to answer key scientific questions in drug development and articulate challenges posed by quality issues, data availability, and integration from various sources as well as the increased need for multidimensional-omics data that can better guide the development of personalized and predictive medicine.


Assuntos
Farmacologia Clínica , Humanos , Criança , Atenção à Saúde , Desenvolvimento de Medicamentos , Preparações Farmacêuticas
17.
Ann Allergy Asthma Immunol ; 106(2): 103-9, 2011 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21277511

RESUMO

BACKGROUND: Children with asthma living in urban environments experience disproportionately high asthma hospitalization rates. Excessive exposure to perennial allergens, including cockroach and house dust mite (HDM), have been implicated, but data are limited. OBJECTIVE: To examine the relation between cockroach and HDM exposure and measures of asthma morbidity and health care utilization. METHODS: Participants included 86 atopic asthmatic children living in New Orleans, Louisiana. Sensitization status was determined by means of serum specific IgE testing, and vacuum dust samples were collected for allergen analysis. Logistic regression analysis was used to assess the odds of persistent wheezing, emergency department visits, and asthma hospitalization in those with high vs low levels of allergen exposure. RESULTS: Approximately 44% and 40% of children were exposed to Bla g 1 levels greater than 2 U/g and HDM levels greater than 2 µg/g, respectively, and 24% reported at least 1 hospitalization in the previous 4 months. The median Bla g 1 level was significantly higher in the homes of children hospitalized compared with those with no hospital admissions (7.2 vs 0.8 U/g). In multivariable models, the odds of hospitalization were significantly higher in children exposed to Bla g 1 levels greater than 2 U/g (adjusted odds ratio, 4.2; 95% confidence interval, 1.24-14.17), independent of sensitization status. Exposure to HDMs was not associated with any measure of morbidity. CONCLUSIONS: Exposure to cockroach allergen was strongly associated with increased hospitalization in children with asthma. This effect cannot be explained entirely by IgE-mediated inflammation. Controlled interventional trials are needed to determine whether isolated cockroach abatement improves asthma control.


Assuntos
Asma/etiologia , Baratas/imunologia , Hospitalização/estatística & dados numéricos , Adolescente , Animais , Criança , Pré-Escolar , Estudos Transversais , Feminino , Humanos , Imunoglobulina E/sangue , Masculino , Análise Multivariada , Pyroglyphidae/imunologia
18.
J Asthma ; 48(6): 581-8, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21668319

RESUMO

BACKGROUND: Despite the National Asthma Education and Prevention Program (NAEPP) guidelines that specify the goals of asthma control and management strategies, the number of patients with uncontrolled asthma remains high, and factors associated with uncontrolled asthma are unknown. OBJECTIVE: The aim was to examine the relationship between asthma control and socio-demographic characteristics, health-care access and use, asthma education, and medication use among adults with active asthma residing in New England. METHODS: Data from the 2006-2007 Behavior Risk Factor Surveillance System Adult Asthma Call-Back Survey were analyzed using multinomial logistic regression. Asthma control was categorized as "well controlled," "not well controlled," or "very poorly controlled" according to the NAEPP guidelines. RESULTS: Of the respondents (n = 3079), 30% met the criteria for well-controlled asthma, 46% for not well-controlled asthma, and 24% for very poorly controlled asthma. Being of Hispanic ethnicity (odds ratio [OR] = 4.0; 95% confidence interval [CI] = 1.2-13.7), unemployed or unable to work (OR = 17.9; 95% CI = 6.0-53.4), high school educated or less (OR = 2.8; 95% CI = 1.6-4.7), current smokers (OR = 2.5; 95% CI = 1.3-5.1), or being unable to see a doctor or specialist for asthma care or unable to buy medication for asthma because of cost (OR = 7.6; 95% CI = 3.4-17.1) were associated with very poorly controlled asthma. In addition, having Coronary Obstructive Pulmonary Disease (COPD) (OR = 2.6; 95% CI = 1.5-4.5), two or more routine checkups for asthma (OR = 4.5; 95% CI = 2.3-8.9), or an emergency department visit, urgent care facility visit, and hospitalization in the past year (OR = 3.9; 95% CI = 2.1-7.3) were also associated with having very poorly controlled asthma. Using controller medication in the past year (OR = 2.6; 95% CI = 1.6-4.2) and taking a course on how to manage asthma (OR = 3.0; 95% CI = 1.2-7.8) were significantly associated with poor asthma control. CONCLUSION: The high prevalence (70%) of not well-controlled asthma and poorly controlled asthma in this study emphasizes the need to identify factors associated with poor asthma control for development of targeted intervention. A health policy of increasing asthma education, health-care access, and smoking cessation may be effective and result in better asthma control and management.


Assuntos
Asma/epidemiologia , Asma/terapia , Demografia/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/estatística & dados numéricos , Asma/tratamento farmacológico , Sistema de Vigilância de Fator de Risco Comportamental , Índice de Massa Corporal , Estudos Transversais , Depressão/epidemiologia , Escolaridade , Serviços Médicos de Emergência/estatística & dados numéricos , Emprego , Feminino , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Hispânico ou Latino/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Humanos , Seguro Saúde/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , New England/epidemiologia , Educação de Pacientes como Assunto/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Grupos Raciais/estatística & dados numéricos , Fumar/epidemiologia , Fatores Socioeconômicos , Adulto Jovem
19.
Public Health Rep ; 126 Suppl 1: 108-15, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21563718

RESUMO

OBJECTIVES: Carbon monoxide (CO) poisoning is a leading cause of morbidity and mortality during natural disasters. On January 26-27, 2009, a severe ice storm occurred in Kentucky, causing widespread, extended power outages and disrupting transportation and communications. After the storm, CO poisonings were reported throughout the state. The objectives of this investigation were to determine the extent of the problem, identify sources of CO poisoning, characterize cases, make recommendations to reduce morbidity and mortality, and develop prevention strategies. METHODS: We obtained data from the Kentucky Regional Poison Center (KRPC), hyperbaric oxygen treatment (HBOT) facilities, and coroners. Additionally, the Kentucky Department for Public Health provided statewide emergency department (ED) and hospitalization data. RESULTS: During the two weeks after the storm, KRPC identified 144 cases of CO poisoning; exposure sources included kerosene heaters, generators, and propane heaters. Hospitals reported 202 ED visits and 26 admissions. Twenty-eight people received HBOT. Ten deaths were attributed to CO poisoning, eight of which were related to inappropriate generator location. Higher rates of CO poisoning were reported in areas with the most ice accumulation. CONCLUSIONS: Although CO poisonings are preventable, they continue to occur in postdisaster situations. Recommendations include encouraging use of CO alarms, exploring use of engineering controls on generators to decrease CO exposure, providing specific information regarding safe use and placement of CO-producing devices, and using multiple communication methods to reach people without electricity.


Assuntos
Intoxicação por Monóxido de Carbono/epidemiologia , Desastres/estatística & dados numéricos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Adolescente , Adulto , Idoso , Intoxicação por Monóxido de Carbono/etiologia , Intoxicação por Monóxido de Carbono/prevenção & controle , Criança , Pré-Escolar , Fontes Geradoras de Energia/normas , Fontes Geradoras de Energia/estatística & dados numéricos , Feminino , Humanos , Gelo , Lactente , Recém-Nascido , Kentucky/epidemiologia , Masculino , Pessoa de Meia-Idade
20.
Public Health Rep ; 125(3): 423-32, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-20433037

RESUMO

OBJECTIVE: Carbon monoxide (CO) poisoning is preventable, yet it remains one of the most common causes of poisoning in the U.S. In the absence of a national data reporting system for CO-poisoning surveillance, the burden of CO-related hospitalizations is unknown. Our objective was to generate the first national estimates of CO-related hospitalizations and to evaluate the use of a Web-based query system for public health surveillance. METHODS: The Healthcare Cost and Utilization Project's (HCUP's) 2005 Nationwide Inpatient Sample (NIS) data were used for CO-related hospitalization estimates. Data for confirmed, probable, and suspected cases were generated using the HCUPnet Web-based query system. We used data from 1993 through 2005 NIS to describe trends in CO-related hospitalizations. We used the Centers for Disease Control and Prevention's surveillance evaluation guidelines to evaluate the system. RESULTS: In 2005, there were 24,891 CO-related hospitalizations nationwide: 16.9% (n=4,216) were confirmed, 1.1% (n=279) were probable, and 81.9% (n=20,396) were suspected CO-poisoning cases. Of the confirmed cases (1.42/100,000 population), the highest hospitalization rates occurred among males, older adults (aged > or = 85 years), and Midwestern residents. CO-related hospitalization rates declined from 1993 through 2000 and plateaued from 2001 through 2005. The simplicity, acceptability, sensitivity, and representativeness of the HCUPnet surveillance system were excellent. However, HCUPnet showed limited flexibility and specificity. CONCLUSIONS: Nationwide, the burden of CO exposure resulting in hospitalization is substantial. HCUPnet is a useful surveillance tool that efficiently characterized CO-related hospitalizations for the first time. Public health practitioners can utilize this data source for state-level surveillance.


Assuntos
Intoxicação por Monóxido de Carbono/epidemiologia , Bases de Dados Factuais , Hospitalização/estatística & dados numéricos , Armazenamento e Recuperação da Informação , Vigilância da População/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Classificação Internacional de Doenças , Internet , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Estados Unidos/epidemiologia
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