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1.
Clin Appl Thromb Hemost ; 30: 10760296231213073, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38173351

RESUMO

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired hematologic disorder commonly treated with complement inhibitors such as eculizumab, ravulizumab, and pegcetacoplan. This study aims to describe treatment patterns, healthcare resource utilization, and cost for newly diagnosed PNH patients in 2 large, health insurance claims databases: MarketScan and Optum. Among the 271 patients meeting the inclusion criteria in MarketScan, 57.9% were female, and the average age was 46.6 years. Among these newly diagnosed patients, 25.1% (n = 68) of patients received a PNH-specific pharmacologic treatment, and the average time from diagnosis to treatment was 4.7 months. The medication possession ratio was 97.0%, but discontinuation was common (58.8%). The average per-patient-per-month costs were $18,978, driven by pharmacy and infusion ($11,182), outpatient ($4086), and inpatient ($3318) costs. Despite the availability of multiple treatments, 39.9% of patients had an inpatient stay, and 50.9% had an emergency department visit. Better care management and the introduction of new treatment options are needed to address delays between diagnosis and treatment, and high rates of hospitalization and emergency department use among patients with PNH.


Assuntos
Hemoglobinúria Paroxística , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Hemoglobinúria Paroxística/tratamento farmacológico , Hemoglobinúria Paroxística/diagnóstico , Estudos Retrospectivos , Atenção à Saúde , Análise de Dados
2.
Patient Relat Outcome Meas ; 14: 369-381, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38046665

RESUMO

Background: Children with sickle cell disease (SCD) experience a multiplex of disease-related symptoms and complications, including vaso-occlusive crises (VOCs), episodes characterized by extreme pain. Methods: A cross-sectional observational survey examined the health-related quality of life (HRQoL) and school experiences of children with SCD 2 months-11 years, burden experienced by their caregivers, and associations between these outcomes and VOC frequency. Caregivers (N=167) of children with SCD in the US completed the Infant-Toddler Quality of Life-Short Form 47 (ITQoL-SF47) for children 2 months-4 years, the Child Health Questionnaire-Parent Form 50 (CHQ-PF50) and PROMIS Pain Interference and Sleep Disturbance Parent Proxy short forms for children 5-11 years, and a study-specific survey of school experiences. Results: Children with SCD 2 months-4 years had lower ITQoL-SF47 scores (ie, worse HRQoL, p<0.001) than a normative sample of children; across domains, differences ranged from 18.73-45.03 points and exceeded minimal important difference (MID) thresholds. Except for the behavior domain, children with SCD 5-11 years had lower scores on all CHQ-PF50 domains than the normative sample (p<0.001); differences ranged from 6.78-36.37 points and exceeded MID thresholds. Children with more frequent VOCs had lower HRQoL and worse school experiences than children with less frequent VOCs (p<0.05, except for behavior domains). The largest differences based on VOC frequency were observed for overall health and bodily pain/discomfort among children 2 months-4 years (differences=40.88 and 32.50 points, respectively), and bodily pain and role/social limitations due to physical health among children 5-11 years (differences=38.99 and 37.80, respectively). Caregivers of children with more frequent VOCs experienced greater burden than caregivers of children with less frequent VOCs, though specific areas of impact (eg, caregiver emotions, time) differed across child age groups. Conclusion: VOC frequency is negatively associated with HRQoL, highlighting the burden experienced by children with SCD and their caregivers.

3.
Curr Med Res Opin ; 39(4): 555-565, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36883332

RESUMO

OBJECTIVE: To provide real-word evidence of patients with SCD initiating crizanlizumab, their use of other SCD treatments, and crizanlizumab treatment patterns. METHODS: Using IQVIA's US-based, Longitudinal Patient-Centric Pharmacy and Medical Claims Databases patients with a diagnosis of SCD between November 1, 2018, and April 30, 2021, and ≥1 claim for crizanlizumab (date of first claim = index date) between November 1, 2019, and January 31, 2021 who were ≥16 years of age, and had ≥12 months of pre-index data were selected for analysis. Two cohorts were identified based on available follow-up time (3- and 6-month cohorts). Patient characteristics were reported along with pre- and post-index SCD treatments and crizanlizumab treatment patterns (e.g. total doses received, gap-days between doses, days on therapy, discontinuation, and restarts). RESULTS: 540 patients met the base inclusion criteria (345 in the 3-month cohort and 262 in the 6-month cohort. Most patients (64%) were female with a mean (SD) age of 35 (12) years overall. Concomitant hydroxyurea use was observed in 19-39% of patients, while concomitant L-glutamine use was observed for 4-8% of patients. 85% of 3-month cohort patients received at least two doses of crizanlizumab, while 66% of the 6-month cohort received at least 4 doses of crizanlizumab. The median number of gap days between doses was 1 or 2. CONCLUSIONS: 66% of patients who receive crizanlizumab receive at least 4 doses within 6-months. The low median number of gap days suggests high adherence.


Assuntos
Anemia Falciforme , Anticorpos Monoclonais Humanizados , Humanos , Feminino , Adulto , Masculino , Estudos Retrospectivos , Anticorpos Monoclonais Humanizados/uso terapêutico , Hidroxiureia/uso terapêutico , Anemia Falciforme/complicações , Anemia Falciforme/tratamento farmacológico
4.
EJHaem ; 3(4): 1135-1144, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36467832

RESUMO

Complications associated with sickle cell disease (SCD) that are highly impactful for patients but until recently have been less understood include priapism, nephropathy, and neurologic injury. We conducted a retrospective study using US administrative claims data from July 01, 2013 through March 31, 2020 to analyze incidence of these complications, SCD treatment patterns, and healthcare resource utilization (HCRU) and costs among 2524 pediatric and adult patients with SCD (mean [SD] age 43.4 [22.4] years). The most common treatments during follow-up were short-acting opioids (54.0% of patients), red blood cell transfusion (15.9%), and hydroxyurea (11.0%). SCD complications occurred frequently; in the overall population, the highest follow-up incidences per 1000 person-years were for acute kidney injury (53.1), chronic kidney disease (40.6), and stroke (39.0). Complications occurred across all age groups but increased in frequency with age; notably, acute kidney injury was 69.7 times more frequent among ages 65+ than ages 0-15 (p < 0.001). Follow-up per-patient-per-month HCRU also increased with age; however, all-cause healthcare costs were similarly high for all age groups and were driven primarily by inpatient stays. Patients with SCD across the age spectrum have a high burden of complications with the use of current treatments, suggesting unmet needs for treatment management.

5.
Contemp Clin Trials ; 115: 106630, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34838717

RESUMO

BACKGROUND: Head and neck cancers are increasingly associated with human papillomavirus (HPV) infection. Previous studies of oral HPV indicate considerable heterogeneity across geographic regions and by sex, but studies differ in methodologies used and risk groups included. Understanding the natural history of oral HPV in the general population is important to assess HPV-related disease burden and plan effective prevention programs. In this study, we aim to assess the prevalence, incidence, and persistence of oral HPV among adult men and women. Factors independently associated with oral HPV will also be evaluated. METHODS: The PROGRESS (PRevalence of Oral hpv infection, a Global aSSessment) study is a non-interventional study of 7877 healthy men and women aged 18-60 years, from France, Germany, Spain, the United Kingdom (UK) and the United States (US). Oral HPV prevalence will be measured using a commercially available PCR DNA test. In the US, participants will be followed prospectively every 6 months for 24 months to assess incidence, clearance, and persistence of oral HPV infection. Eligible individuals presenting for regular dental check-ups will be recruited from participating dental offices via systematic consecutive sampling. Participant dentists will collect clinical characteristics, and participants will complete self-reported study questionnaires and provide an oral rinse and gargle (ORG) specimen for HPV-DNA detection and genotyping at each study visit. HPV-DNA detection and genotyping will be performed in two reference laboratories, using the SPF10/DEIA/LiPA25 system. DISCUSSION: PROGRESS study aims to fill knowledge gaps concerning the natural history of oral HPV using a standardized methodology. PROGRESS will also assess factors associated with oral HPV prevalence and natural history in the general population.


Assuntos
Alphapapillomavirus , Doenças da Boca , Infecções por Papillomavirus , Adulto , Feminino , Humanos , Masculino , Doenças da Boca/epidemiologia , Papillomaviridae/genética , Prevalência , Fatores de Risco , Estados Unidos
6.
Curr Oncol ; 28(1): 991-1007, 2021 02 22.
Artigo em Inglês | MEDLINE | ID: mdl-33617515

RESUMO

Background: Since 2007, all Canadian provinces and territories have had a publicly funded program for vaccination against human papillomavirus (HPV) infection. The objective of this study was to describe the evolution of these vaccination programs. Methods: This was a targeted literature review of public HPV vaccination programs and vaccination coverage rates, based on information provided by jurisdictional public health authorities. Results: HPV vaccination of schoolgirls began in school years 2007/08 to 2010/11 with three doses of the quadrivalent HPV vaccine in all provinces except Quebec, which started with two doses. By 2018/19, all jurisdictions were vaccinating with two doses of the nonavalent vaccine in both girls and boys, except Quebec, which used a mixed vaccination schedule with one dose of the nonavalent and one dose of the bivalent vaccines. Public HPV vaccination programs in most provinces include after-school catch-up vaccination. Immunocompromised or other high-risk individuals are eligible for the HPV public vaccination program in most provinces, but policies vary by jurisdiction. In 2017/18, vaccination coverage rates in provincial HPV school-based programs varied from 62% in Ontario to 86% in Prince Edward Island in girls and from 58% in Ontario to 86% in Prince Edward Island in boys. Conclusions: Since their introduction, Canadian school-based HPV public vaccination programs have evolved from a three-dose to a two-dose schedule, from a quadrivalent to a nonavalent vaccine, and from a girls-only to a gender-neutral policy. Vaccination coverage rates have varied markedly and only Prince Edward Island and Newfoundland/Labrador have maintained rates exceeding 80%.


Assuntos
Alphapapillomavirus , Vacinas contra Papillomavirus , Feminino , Humanos , Programas de Imunização , Masculino , Ontário , Saúde Pública , Vacinação
7.
Vaccine ; 39(16): 2214-2223, 2021 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-33658126

RESUMO

INTRODUCTION: Studies on the cross-protective effect of HPV bivalent and quadrivalent vaccines demonstrated inconsistent findings against additional HPV types covered by the nonavalent vaccine. The objective of this study was to conduct a systematic literature review to assess the consistency and durability of the cross-protective neutralizing antibody immune responses of the currently licensed bivalent and quadrivalent vaccines to non-vaccine HPV types targeted by the nonavalent vaccine (HPV 6, 11, 31, 33, 45, 52, and 58). METHODS: PubMed and EMBASE databases were searched from 2008 to 2019 to identify studies reporting antibody/immune response after vaccination with either the bivalent, quadrivalent, or nonavalent vaccine. Key outcomes were seroconversion, seropositivity or geometric mean titers against HPV types 6, 11, 31, 33, 45, 52, and 58. RESULTS: Eighteen publications met inclusion criteria, reporting on 14 interventional and five observational studies. Across all studies, immune responses to non-vaccine high-risk HPV types after bivalent vaccination were higher than baseline or quadrivalent vaccine. Nonavalent vaccine elicited near total seroconversion to HPV types 31, 33, 45, 52, and 58, with seropositivity remaining near 100% up to 24 months post-dose 1. In contrast, bivalent and quadrivalent vaccination resulted in lower seroconversion levels for non-vaccine types, which waned over time. CONCLUSIONS: The cross-protection antibody/immune response among participants having received all three doses of bivalent or quadrivalent vaccine is not comparable to the specific response elicited by HPV vaccine types. Even in cases where a statistically significant cross-reactive immunological response is reported, long-term data on the duration of the response beyond two years are very limited. Further, the lack of a standard for assays limits comparability of results between studies.


Assuntos
Infecções por Papillomavirus , Vacinas contra Papillomavirus , Anticorpos Neutralizantes , Proteção Cruzada , Vacina Quadrivalente Recombinante contra HPV tipos 6, 11, 16, 18 , Humanos , Infecções por Papillomavirus/prevenção & controle , Vacinas Combinadas
8.
Vaccine ; 39(16): 2224-2236, 2021 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-33744051

RESUMO

BACKGROUND: The extent of cross-protection provided by currently licensed bivalent and quadrivalent HPV vaccines versus direct protection against HPV 31-, 33-, 45-, 52-, and 58-related disease is debated. A systematic literature review was conducted to establish the duration and magnitude of cross-protection in interventional and observational studies. METHODS: PubMed and Embase databases were searched to identify randomized controlled trials (RCT) and observational studies published between 2008 and 2019 reporting on efficacy and effectiveness of HPV vaccines in women against non-vaccine types 31, 33, 45, 52, 58, and 6 and 11 (non-bivalent types). Key outcomes of interest were vaccine efficacy against 6- and 12-month persistent infection or genital lesions, and type-specific genital HPV prevalence or incidence. RCT data were analyzed for the according-to-protocol (bivalent vaccine) or negative-for-14-HPV-types (quadrivalent vaccine) efficacy cohorts. RESULTS: Data from 23 RCTs and 33 observational studies evaluating cross-protection were extracted. RCTs assessed cross-protection in post-hoc analyses of small size subgroups. Among fully vaccinated, baseline HPV-naïve women, the bivalent vaccine showed statistically significant cross-protective efficacy, although with wide confidence intervals, against 6-month and 12-month persistent cervical infections and CIN2+ only consistently for HPV 31 and 45, with the highest effect observed for HPV 31 (range 64.6% [95% CI: 27.6 to 83.9] to 79.1% [97.7% CI: 27.6 to 95.9] for 6-month persistent infection; maximal follow-up 4.7 years). No cross-protection was shown in extended follow-up. The quadrivalent vaccine efficacy reached statistical significance for HPV 31 (46.2% [15.3-66.4]; follow-up: 3.6 years). Similarly, observational studies found consistently significant effectiveness only against HPV 31 and 45 with both vaccines. CONCLUSIONS: RCTs and observational studies show that cross-protection is inconsistent across non-vaccine HPV types and is largely driven by HPV 31 and 45. Furthermore, existing data suggest that it wanes over time; its long-term durability has not been established.


Assuntos
Infecções por Papillomavirus , Vacinas contra Papillomavirus , Neoplasias do Colo do Útero , Proteção Cruzada , Feminino , Humanos , Infecções por Papillomavirus/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto
9.
Biopreserv Biobank ; 13(2): 107-13, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25853387

RESUMO

OBJECTIVE: Biorepositories have been key resources in examining genetically-linked diseases, particularly cancer. Asian Americans contribute to biorepositories at lower rates than other racial groups, but the reasons for this are unclear. We hypothesized that attitudes toward biospecimen research mediate the relationship between demographic and healthcare access factors, and willingness to donate blood for research purposes among individuals of Korean heritage. METHODS: Descriptive statistics and bivariate analyses were utilized to characterize the sample with respect to demographic, psychosocial, and behavioral variables. Structural equation modeling with 5000 re-sample bootstrapping was used to assess each component of the proposed simple mediation models. RESULTS: Attitudes towards biospecimen research fully mediate associations between age, income, number of years lived in the United States, and having a regular physician and willingness to donate blood for the purpose of research. CONCLUSION: Participants were willing to donate blood for the purpose of research despite having neutral feelings towards biospecimen research as a whole. Participants reported higher willingness to donate blood for research purposes when they were older, had lived in the United States longer, had higher income, and had a regular doctor that they visited. Many of the significant relationships between demographic and health care access factors, attitudes towards biospecimen research, and willingness to donate blood for the purpose of research may be explained by the extent of acculturation of the participants in the United States.


Assuntos
Asiático/psicologia , Bancos de Sangue , Conhecimentos, Atitudes e Prática em Saúde/etnologia , Adulto , Idoso , Pesquisa Participativa Baseada na Comunidade , Diversidade Cultural , Feminino , Acessibilidade aos Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , República da Coreia/etnologia , Fatores de Risco , Inquéritos e Questionários
10.
DST j. bras. doenças sex. transm ; 32: 1-8, jan. 12, 2020.
Artigo em Inglês | LILACS | ID: biblio-1148228

RESUMO

Introduction: Genital warts are benign lesions caused by sexual transmission of human papillomavirus types 6 and 11, with significant impact on healthcare resource use and patients' quality of life. Objective: To describe the epidemiology of genital warts in adults visiting a physician office for any reason, physician practice patterns, and healthcare resource use and costs in Colombia. Methods: Participants were a convenience sample of 53 physicians in 5 specialties: primary care (15), gynecology (24), urology (12), proctology (1), and dermatology (1). Physicians completed a survey and daily log of all patients 18-60 years old seen over 10 days in their practices in 2016-2017. The physician survey recorded genital warts consultation and management patterns. The daily log recorded patient demographic information and genital warts diagnosis. Results: Among 6,393 patients logged by physicians, the genital warts prevalence was 2.03% (95%CI 1.69­2.38) and incidence 1.30% (95%CI 1.02­1.58). Primary care physicians referred most of their genital warts cases for treatment (female: mean 63.3%, SD=44.8; male: mean 58.3%, SD=43.8). Treatment of non-resistant episodes (<6-month duration) lasted an average of 37.4 days (SD=29.4) and required an average of 4.0 (SD=1.9) office visits for females and 3.0 (SD=1.7) for males. The overall mean cost of an episode of care was USD558.13 (SD=507.30). Conclusion: Genital warts cases reported by most participant physicians were mainly direct-consult, but patients were typically treated by specialists. Much of the genital warts health care utilization and costs reported could be prevented by immunization with the quadrivalent or nonavalent HPV vaccine.


Introdução: As verrugas genitais são lesões benignas, de transmissão sexual, causadas pelo papilomavírus humano tipos 6 e 11 e que causam impacto significativo no uso de recursos de saúde e na qualidade de vida dos pacientes. Objetivo: Descrever a epidemiologia das verrugas genitais em adultos que buscaram atendimento médico ambulatorial por qualquer motivo, incluindo padrões de prática médica, uso de recursos de saúde e custos na Colômbia. Métodos: foi utilizada uma amostra de conveniência composta por 53 médicos em 5 especialidades: clínico geral (15), ginecologia (24), urologia (12), proctologia (1) e dermatologia (1). Os médicos completaram um questionário e registros diários de todos os pacientes com idade entre 18 e 60 anos atendidos durante 10 dias em seus consultórios em 2016-2017. O questionário registrou os padrões de prática médica e de tratamento de verrugas genitais. Os registros diários continham informações demográficas do paciente e o diagnóstico de verrugas genitais. Resultados: Entre 6.393 atendimentos médicos, a prevalência das verrugas genitais foi de 2,03% (IC95% 1,69­2,38) e a incidência de 1,30% (IC95% 1,02­1,58). Os clínicos gerais encaminharam a maioria dos pacientes com verrugas genitais para tratamento (mulheres: média de 63,3%, DP=44,8; homens: média de 58,3%, DP=43,8). O tratamento dos casos não-persistentes (<6 meses de duração) durou em média 37,4 dias (DP=29,4) e requereu uma média de 4,0 (DP=1,9) consultas para mulheres e 3,0 (DP=1,7) para homens. O custo médio geral do tratamento foi de US$ 558,13 (SD=507,30). Conclusão: Os casos de verrugas genitais relatados pela maioria dos médicos participantes derivaram-se principalmente de atendimentos primários e os pacientes foram tratados geralmente por especialistas. Grande parte da utilização de recursos e custos relacionados a verrugas genitais poderia ser evitada pela imunização com a vacina papilomavírus humano 4-valente ou 9-valente.


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Adulto Jovem , Verrugas/epidemiologia , Doenças dos Genitais Femininos/epidemiologia , Doenças dos Genitais Masculinos/epidemiologia , Verrugas/economia , Verrugas/virologia , Aceitação pelo Paciente de Cuidados de Saúde , Incidência , Prevalência , Custos de Cuidados de Saúde , Colômbia/epidemiologia , Doenças dos Genitais Femininos/economia , Doenças dos Genitais Femininos/virologia , Doenças dos Genitais Masculinos/economia , Doenças dos Genitais Masculinos/virologia
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