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Participants in studies investigating COVID-19 vaccines commonly report reactogenicity events, and concerns about side effects may lead to a reluctance to receive updated COVID-19 vaccinations. A real-world, post hoc analysis, observational 2019nCoV-406 study was conducted to examine reactogenicity within the first 2 days after vaccination with either a protein-based vaccine (NVX-CoV2373) or an mRNA vaccine (BNT162b2 or mRNA-1273) in individuals who previously completed a primary series. Propensity score adjustments were conducted to address potential confounding. The analysis included 1130 participants who received a booster dose of NVX-CoV2373 (n = 303) or an mRNA vaccine (n = 827) during the study period. Within the first 2 days after vaccination, solicited systemic reactogenicity events (adjusted) were reported in 60.5% of participants who received NVX-CoV2373 compared with 84.3% of participants who received an mRNA vaccine; moreover, 33.9% and 61.4%, respectively, reported ≥3 systemic reactogenicity symptoms. The adjusted mean (95% CI) number of systemic symptoms was 1.8 (1.6-2.0) and 3.2 (3.0-3.4), respectively. Local reactogenicity events (adjusted) were reported in 73.4% and 91.7% of participants who received NVX-CoV2373 and mRNA vaccines, respectively; the adjusted mean (95% CI) number of local symptoms was 1.5 (1.33-1.61) and 2.4 (2.31-2.52), respectively. These results support the use of adjuvanted, protein-based NVX-CoV2373 as an immunization option with lower reactogenicity than mRNAs.
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Policymakers in the United States (US) recommend coronavirus disease 2019 (COVID-19) vaccination with a monovalent 2023-2024 vaccine formulation based on the Omicron XBB.1.5 variant. We estimated the potential US population-level health and economic impacts of increased COVID-19 vaccine coverage that might be expected with the availability of a protein-based vaccine with simpler storage requirements in addition to messenger ribonucleic acid (mRNA) vaccines. A Markov model was developed to estimate 1-year COVID-19-related costs, cases, hospitalizations, and deaths with and without the availability of a protein-based vaccine option. The model population was stratified by age and risk status. Model inputs were sourced from published literature or derived from publicly available data. Our model estimated that a five-percentage-point increase in coverage due to the availability of a protein-based vaccine option would prevent over 500,000 cases, 66,000 hospitalizations, and 3000 COVID-19-related deaths. These clinical outcomes translated to 42,000 quality-adjusted life years (QALYs) gained and an incremental cost-effectiveness ratio of USD 16,141/QALY from a third-party payer perspective. In sensitivity analyses, outcomes were most sensitive to COVID-19 incidence and severity across age groups. The availability of a protein-based vaccine option in the US could reduce hospitalizations and deaths and is predicted to be cost-effective.
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COVID-19 continues to be a global health concern and booster doses are necessary for maintaining vaccine-mediated protection, limiting the spread of SARS-CoV-2. Despite multiple COVID vaccine options, global booster uptake remains low. Reactogenicity, the occurrence of adverse local/systemic side effects, plays a crucial role in vaccine uptake and acceptance, particularly for booster doses. We conducted a targeted review of the reactogenicity of authorized/approved mRNA and protein-based vaccines demonstrated by clinical trials and real-world evidence. It was found that mRNA-based boosters show a higher incidence and an increased severity of reactogenicity compared with the Novavax protein-based COVID vaccine, NVX-CoV2373. In a recent NIAID study, the incidence of pain/tenderness, swelling, erythema, fatigue/malaise, headache, muscle pain, or fever was higher in individuals boosted with BNT162b2 (0.4 to 41.6% absolute increase) or mRNA-1273 (5.5 to 55.0% absolute increase) compared with NVX-CoV2373. Evidence suggests that NVX-CoV2373, when utilized as a heterologous booster, demonstrates less reactogenicity compared with mRNA vaccines, which, if communicated to hesitant individuals, may strengthen booster uptake rates worldwide.
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PREVENT-19, the pivotal phase 3 trial of the Novavax adjuvanted, recombinant spike protein COVID-19 vaccine (NVX-CoV2373), demonstrated that the vaccine was well tolerated and efficacious (vaccine efficacy, VE = 90%) for the prevention of symptomatic COVID-19. In the trial, participants were randomly assigned in a 2:1 ratio to receive 2 doses of NVX-CoV2373 or placebo 21 days apart. Throughout the study, the predominant SARS-CoV-2 variant was alpha, but additional variants were in circulation (i.e., beta, gamma, epsilon, and iota). VE among the per-protocol efficacy analysis population was calculated according to pre-specified disease severity (mild, moderate, or severe) criteria, but the impact on the risk of COVID-19-associated hospitalization was not specifically investigated. During this analysis period (January 25, 2021, to April 30, 2021 [95 days]), 4 hospitalizations occurred among the 77 events analyzed for the primary endpoint using the per-protocol population, 0 among vaccine recipients and 4 among placebo recipients, yielding a post hoc VE against hospitalization of 100% (95% CI: 28.8, 100). Among an expanded efficacy population, also identified post hoc, which included COVID-19-associated hospitalizations without a requirement for diagnostic polymerase chain reaction testing performed at the study central laboratory, 12 total hospitalizations were identified, 0 among vaccine recipients and 12 among placebo recipients, yielding a post hoc VE against hospitalization of 100% (95% CI: 83.1, 100). These additional data from the PREVENT-19 trial provide relevant public health information concerning the attributes of NVX-CoV2373.
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COVID-19 , Vacinas , Humanos , SARS-CoV-2 , Vacinas contra COVID-19 , COVID-19/prevenção & controle , Eficácia de VacinasRESUMO
OBJECTIVES: Model-based cost-effectiveness analyses on maternal vaccine (MV) and monoclonal antibody (mAb) interventions against respiratory syncytial virus (RSV) use context-specific data and produce varied results. Through model comparison, we aim to characterize RSV cost-effectiveness models and examine drivers for their outputs. METHODS: We compared 3 static and 2 dynamic models using a common input parameter set for a hypothetical birth cohort of 100 000 infants. Year-round and seasonal programs were evaluated for MV and mAb interventions, using available evidence during the study period (eg, phase III MV and phase IIb mAb efficacy). RESULTS: Three static models estimated comparable medically attended (MA) cases averted versus no intervention (MV, 1019-1073; mAb, 5075-5487), with the year-round MV directly saving â¼1 million medical and 0.3 million nonmedical costs, while gaining 4 to 5 discounted quality-adjusted life years (QALYs) annually in <1-year-olds, and mAb resulting in 4 million medical and 1.5 million nonmedical cost savings, and 21 to 25 discounted QALYs gained. In contrast, both dynamic models estimated fewer MA cases averted (MV, 402-752; mAb, 3362-4622); one showed an age shift of RSV cases, whereas the other one reported many non-MA symptomatic cases averted, especially by MV (2014). These differences can be explained by model types, assumptions on non-MA burden, and interventions' effectiveness over time. CONCLUSIONS: Our static and dynamic models produced overall similar hospitalization and death estimates, but also important differences, especially in non-MA cases averted. Despite the small QALY decrement per non-MA case, their larger number makes them influential for the costs per QALY gained of RSV interventions.
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Infecções por Vírus Respiratório Sincicial , Vírus Sinciciais Respiratórios , Criança , Humanos , Lactente , Anticorpos Monoclonais/uso terapêutico , Análise Custo-Benefício , Análise de Custo-Efetividade , Infecções por Vírus Respiratório Sincicial/prevenção & controleRESUMO
Two blood-based brain biomarker tests such as the combination of glial fibrillary acidic protein and ubiquitin C-terminal hydrolase-L1 (GFAP+UCH-L1) or S100B have potential to reduce the need for head computed tomography (CT) scanning in patients with mild traumatic brain injury (mTBI). We assessed the clinical and economic impact of using GFAP+UCH-L1 versus CT scan and GFAP+UCH-L1 versus S100B to screen adults with suspected mTBI presenting to an emergency department (ED). A decision model was developed to estimate costs and health outcomes of GFAP+UCH-L1, CT scan, and S100B associated with these screening protocols. Model parameters were extracted from peer-reviewed articles, clinical guidelines, and expert opinion. Analysis was performed from a French health care system perspective (costs in 2020 euros). In the model, patients with a positive biomarker receive a CT scan to confirm the presence of intracranial lesions (ICLs). Depending on clinical state and biomarker and CT results, patients were discharged immediately, kept for observation in the ED, admitted for in-hospital stay and observation, or admitted for surgical management. Incorrect test results may lead to delayed treatment and poor outcomes or overtreatment. GFAP+UCH-L1 use was associated with an overall decrease in CT scans when compared with CT screening or S100B use (325.42 and 46.43 CTs per 1000 patients, respectively). The use of GFAP+UCH-L1 resulted in modest cost savings when compared with CT scanning and with S100B. In all cases, use of GFAP+UCH-L1 marginally improved quality-adjusted life-years (QALYs) and outcomes. Thus, screening with GFAP+UCH-L1 reduced the need for CT scans when compared with systematic CT scan screening or use of S100B while maintaining similar costs and health outcomes.
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Concussão Encefálica , Lesões Encefálicas Traumáticas , Adulto , Humanos , Concussão Encefálica/diagnóstico por imagem , Análise Custo-Benefício , Ubiquitina Tiolesterase , Lesões Encefálicas Traumáticas/diagnóstico , Biomarcadores , Encéfalo , Proteína Glial Fibrilar ÁcidaRESUMO
BACKGROUND: Large volume delayed sampling (LVDS) and pathogen reduction technology (PRT) are strategies for platelet processing to minimize transfusion of contaminated platelet components (PCs). This study holistically compares the economic and clinical impact of LVDS and PRT in the United States. STUDY DESIGN AND METHODS: A decision model was constructed to simulate collection, processing, and use of PCs and to compare processing strategies: PRT with 5-day shelf life, LVDS with 7-day shelf life (LVDS7), and LVDS with 5-day shelf life extended to 7 days with secondary testing (LVDS5/2). Target population was adults requiring two or more transfusions. Collection, processing, storage, and distribution data were obtained from the National Blood Collection and Utilization Survey and published literature. Patient outcomes associated with transfusions were obtained from AABB guidelines, meta-analyses, and other published clinical studies. Costs were obtained from reimbursement schedules and other published sources. RESULTS: Given 10,000 donated units, 9512, 9511, and 9651 units of PRT, LVDS5/2, and LVDS7 PCs were available for transfusion, respectively. With these units, 1502, 2172, and 2329 transfusions can be performed with similar levels of adverse events. Assuming 30 transfusions a day, a hospital would require 69,325, 47,940, and 45,383 units of PRT, LVDS5/2, and LVDS7 platelets to perform these transfusions. The mean costs to perform transfusions were significantly higher with PRT units. CONCLUSIONS: Compared with PRT, LVDS strategies were associated with lower costs and higher PC availability while patients experienced similar levels of adverse events. Increased utilization of LVDS has the potential to improve efficiency, expand patient access to platelets, and reduce health care costs.
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Plaquetas , Segurança do Sangue/métodos , Plaquetas/microbiologia , Plaquetas/parasitologia , Plaquetas/virologia , Segurança do Sangue/economia , Humanos , Contagem de Plaquetas , Transfusão de Plaquetas/economia , Transfusão de Plaquetas/métodos , Esterilização/economia , Esterilização/métodos , Estados UnidosRESUMO
OBJECTIVES: To describe study design considerations and to simulate a trial of biomarker-guided sepsis management aimed to reduce acute kidney injury (acute kidney injury). Tissue inhibitor of metalloproteinases-2 and insulin-like growth factor-binding protein 7, urinary biomarkers of cell-cycle arrest, and indicators of kidney stress can detect acute kidney injury before clinical manifestations. We sought to determine the event rates for acute kidney injury as a function of serial measurements of urinary (tissue inhibitor of metalloproteinases-2)â¢(insulin-like growth factor-binding protein 7) in patients at risk of sepsis-associated acute kidney injury, so that an escalating series of kidney-sparing sepsis bundles based on international guidelines could be applied. DESIGN: We described the study protocol of "Limiting acute kidney injury Progression In Sepsis," a phase 4, multicenter, adaptive, randomized controlled trial. We performed simulations to estimate the rates for the trial's primary endpoint using patient-level data from two previous studies (Sapphire and Protocolized Care for Early Septic Shock). SETTING: Academic and community ICUs. PATIENTS: Critically ill patients with sepsis or septic shock, without evidence of stage 2/3 acute kidney injury at enrollment. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Our primary endpoint is progression of two or more stages of acute kidney injury, death, or dialysis within 72 hours after enrollment. In the Sapphire simulation, 45 of 203 patients (22%) with sepsis met the endpoint. In Protocolized Care for Early Septic Shock, 144 of 607 patients (24%) with septic shock met the endpoint. In both simulations, (tissue inhibitor of metalloproteinases-2)â¢(insulin-like growth factor-binding protein 7) patterns, suggested by Limiting acute kidney injury Progression In Sepsis protocol, stratified the risk for the endpoint from 6% (three negative tests) to 41% (for patients eligible for the highest level of kidney-sparing sepsis bundle) in Sapphire, and 14% (two negative tests) to 46% (for the highest level of kidney-sparing sepsis bundle) in Protocolized Care for Early Septic Shock. CONCLUSIONS: Findings of our Limiting acute kidney injury Progression In Sepsis trial simulation confirmed that (tissue inhibitor of metalloproteinases-2)â¢(insulin-like growth factor-binding protein 7) could identify patients with different rates of progression to moderate/severe acute kidney injury, death, or dialysis in 72 hours. The Limiting acute kidney injury Progression In Sepsis protocol algorithm is therefore feasible in terms of identifying suitably high-risk individuals for kidney-sparing sepsis bundle.
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Injúria Renal Aguda/etiologia , Protocolos Clínicos , Sepse/complicações , APACHE , Biomarcadores/análise , Biomarcadores/sangue , Distribuição de Qui-Quadrado , Estudos de Coortes , Feminino , Humanos , Rim/fisiopatologia , Masculino , Pessoa de Meia-IdadeRESUMO
Purpose: To evaluate the budget impact of adding a diagnostic test of tissue inhibitor of metalloproteinase 2 and insulin-like growth factor binding protein 7 ([TIMP-2]·[IGFBP7]), which identifies patients at risk of moderate-to-severe acute kidney injury (AKI), to the current standard of care (SOC) in a hospital setting.Materials and methods: A budget impact model (2017 USD) was developed from the perspective of a hypothetical US hospital system serving 10,000 inpatients annually. The model estimated the impact of assessing the risk of AKI using SOC vs a combination of SOC and the US Food and Drug Administration-approved assay [TIMP-2]·[IGFBP7] over a 1-year period. Potential cost implications were assessed using estimates for payer mix among patients, diagnostic efficacy, and patient healthcare resource utilization. The model also considered provider adoption rates and the estimated costs of [TIMP-2]·[IGFBP7].Results: Compared to SOC alone, adding [TIMP-2]·[IGFBP7] to SOC was associated with a $1,855 reduction in uncompensated care per patient tested, which, after accounting for the additional costs of the test ($277), resulted in net savings of $1,578 per patient tested. The findings were robust to input parameter variations, as demonstrated by deterministic and probabilistic sensitivity analyses. In the probabilistic sensitivity analyses, net cost savings to the hospital ranged from $50,308-$3,971,514, or $101-$7,943 per tested patient (mean = $1,710; 95% confidence interval = $1,691-$1,729).Conclusions: The introduction of [TIMP-2]·[IGFBP7] as a novel tool in the identification of AKI risk may result in considerable cost savings from a hospital perspective under this model's base-case assumptions. Further prospective studies are needed to confirm these findings in a real-world setting.Key points for decision makersAn economic model was constructed to determine the budget impact of adding a diagnostic test ([TIMP-2]·[IGFBP7]), which identifies patients at risk of moderate-to-severe acute kidney injury, to the current standard of care (SOC) in a hospital setting.According to the present model, the use of [TIMP-2]·[IGFBP7] to identify acute kidney injury risk may reduce costs for hospitals by â¼$1,578 per patient tested.
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Injúria Renal Aguda/diagnóstico , Proteínas de Ligação a Fator de Crescimento Semelhante a Insulina/urina , Inibidor Tecidual de Metaloproteinase-2/urina , Urinálise/economia , Biomarcadores , Análise Custo-Benefício , Diagnóstico Precoce , Gastos em Saúde/estatística & dados numéricos , Recursos em Saúde/economia , Serviços de Saúde/economia , Humanos , Estudos Prospectivos , Curva ROC , Medição de Risco , Sensibilidade e Especificidade , Índice de Gravidade de DoençaRESUMO
Objective: To characterize mild traumatic brain injury (mTBI) patients in the USA, describing location of diagnosis, timing, and modality of imaging procedures, health-care resource utilization (HRU) and costs in the 12-month period post-diagnosis. Research Design: Retrospective claims analysis Methods: Anonymized data from the OptumHealth Care Solutions claims database (2006-2016). The index date was the first date with an mTBI diagnosis. HRU and costs (2016 USD) were assessed in the 12-month post-index period. Results: A total of 80,004 patients with mTBI were included: 60% were under 26 years and 54% were male. Mild TBI was most frequently diagnosed in an emergency department (ED) for all age groups, except patients aged 11-17 years, for whom the outpatient setting was the most frequent place of diagnosis. Almost half (47%) received brain imaging on the index date, with 98% of which receiving computed tomography. Mean follow-up health-care costs were $13,564 (SD = $41,071), primarily from inpatient ($4,675, SD = $29,982) and non-ED outpatient/physician office visits ($4,207, SD = $12,697). Older patients had greater HRU and higher health-care costs. Conclusions: The findings of this claims-based study show substantial HRU and costs associated with mTBI diagnosis during a 12-month follow-up period.
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Concussão Encefálica/diagnóstico por imagem , Encéfalo/diagnóstico por imagem , Custos de Cuidados de Saúde , Aceitação pelo Paciente de Cuidados de Saúde , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Concussão Encefálica/economia , Concussão Encefálica/terapia , Criança , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neuroimagem , Estudos Retrospectivos , Estados Unidos , Adulto JovemRESUMO
Previous cost-effectiveness models found ambulatory blood pressure monitoring (ABPM) to be a favorable strategy to diagnose hypertension; however, they mostly focused on older adults with a positive clinic blood pressure (BP) screen. We evaluated the cost-effectiveness of 3 methods of BP measurement for hypertension diagnosis in primary care settings among 14 age- and sex-stratified hypothetical cohorts (adults ≥21 years of age), accounting for the possibility of both false-positive (white-coat hypertension) and false-negative (masked hypertension) clinic measurements. We compared quality-adjusted life-years and lifetime costs ($US 2017 from the US healthcare perspective) associated with clinic BP measurement, home BP monitoring, and ABPM under 2 scenarios: positive and negative initial screen. Model parameters were obtained from published literature, publicly available data sources, and expert input. In the screen-positive scenario, ABPM was the dominant strategy among all age and sex groups. Compared with clinic BP measurement, ABPM was associated with cost-savings ranging from $77 (women 80 years of age) to $5013 (women 21 years of age). In the screen-negative scenario, ABPM was the dominant strategy in all men and women <80 years of age with cost-savings ranging from $128 (women 70 years of age) to $2794 (women 21 years of age). Sensitivity analyses showed that results were sensitive to test specificity and antihypertensive medication costs. ABPM is recommended as the diagnostic strategy of choice for most adults in primary care settings regardless of initial screening results.
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Monitorização Ambulatorial da Pressão Arterial , Custos de Cuidados de Saúde/estatística & dados numéricos , Hipertensão , Atenção Primária à Saúde , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/economia , Determinação da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/economia , Monitorização Ambulatorial da Pressão Arterial/métodos , Análise Custo-Benefício , Reações Falso-Negativas , Reações Falso-Positivas , Feminino , Humanos , Hipertensão/diagnóstico , Hipertensão/economia , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Atenção Primária à Saúde/economia , Atenção Primária à Saúde/métodos , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e Especificidade , Estados Unidos/epidemiologiaRESUMO
RATIONALE, AIMS, AND OBJECTIVES: Despite proven benefits for reducing incidence of major cardiac events, antihypertensive drug therapy remains underutilized in the United States. This analysis assesses antihypertensive drug adherence, utilization predictors, and associations between adherence and outcomes (a composite of cardiovascular events, Medicare inpatient payments, and inpatient days). METHODS: The sample consisted of Atherosclerosis Risk in Communities Study cohort participants reporting hypertension without prevalent cardiovascular disease during 2006 to 2007 annual follow-up calls. Atherosclerosis Risk in Communities records were linked to Medicare claims through 2012. Antihypertensive medication adherence was measured as more than 80% proportion days covered by using Medicare Part D claims. Standard and hierarchical regression models were used to evaluate adjusted associations between person characteristics and adherence and between adherence and outcomes. RESULTS: Among 1826 hypertensive participants with Part D coverage, 31.5% had no antihypertensive class with more than 80% proportion days covered in the 3 months preceding the report of hypertension in 2006 to 2007. After adjustment for confounders, positive predictors of use included female gender and diabetes; negative predictors were African-American race and current smoking. Adjusted association between receiving no therapy and a composite endpoint of cardiovascular outcomes through 2012 was not statistically significant (hazard ratio: 0.93; 95% confidence interval: 0.72, 1.22) nor was the adjusted association with Medicare inpatient days or payments (incremental difference at 48 months in payments: $1217; 95% CI: -$2030, $4463). CONCLUSIONS: Despite having medical and prescription coverage, nearly a third of hypertensive participants were not adherent to antihypertensive drug therapy. Differences in clinical outcomes associated with nonadherence, though not statistically significant, were consistent with results from randomized trials. The approach provides a model framework for rigorous assessment of detailed data that are increasingly available through emerging sources.
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Anti-Hipertensivos/uso terapêutico , Doenças Cardiovasculares/epidemiologia , Hipertensão , Adesão à Medicação/estatística & dados numéricos , Revisão de Uso de Medicamentos/métodos , Revisão de Uso de Medicamentos/estatística & dados numéricos , Feminino , Pesquisa sobre Serviços de Saúde , Humanos , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Vida Independente , Masculino , Medicare Part D/estatística & dados numéricos , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Medição de Risco , Fatores de Risco , Estados Unidos/epidemiologiaRESUMO
The aging population routinely has comorbid conditions requiring complicated medication regimens, yet nonadherence can preclude optimal outcomes. This study explored the association of adherence in the elderly with demographic, socioeconomic, and disease burden measures. Data were from the fifth visit (2011-2013) for 6,538 participants in the Atherosclerosis Risk in Communities Study, conducted in four communities. The Morisky-Green-Levine Scale measured self-reported adherence. Forty percent of respondents indicated some nonadherence, primarily due to poor memory. Logit regression showed, surprisingly, that persons with low reading ability were more likely to report being adherent. Better self-reported physical or mental health both predicted better adherence, but the magnitude of the association was greater for mental than for physical health. Compared with persons with normal or severely impaired cognition, mild cognitive impairment was associated with lower adherence. Attention to mental health measures in clinical settings could provide opportunities for improving medication adherence.
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Disfunção Cognitiva , Adesão à Medicação/psicologia , Adesão à Medicação/estatística & dados numéricos , Saúde Mental , Autorrelato/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Maryland , Minnesota , Mississippi , North Carolina , Fatores SocioeconômicosRESUMO
PURPOSE: This study aims to characterize the symptom burden and life challenges that chordoma patients and their caregivers experience. METHODS: In this cross-sectional study, we analyzed data from the Chordoma Foundation online community survey conducted in 2014. Frequency counts and percentages were calculated to determine the prevalence of self-reported symptoms and life challenges in the sample. We used Fisher's exact test to compare self-reported symptoms among subgroups with different disease status, tumor locations, and treatments received. RESULTS: Among the survey participants, 358 identified themselves as chordoma patients and 208 as caregivers. The majority of the patients were over 45 years (72%), male (56%), educated beyond high school degree (87%), and from North America (77%). Skull base was the most prevalent tumor location (40%). Chronic pain (38%) was the most commonly reported symptom followed by depression or severe anxiety (35%), and chronic fatigue (34%). Among patients, the most commonly-reported challenges included delayed diagnosis (37%), long-term disability (33%), and change in career or reduced ability to work (33%). For caregivers, grief (55%), delayed diagnosis (47%), and difficulty helping the patient cope with his or her disease (45%) were most common. CONCLUSIONS: Our study findings suggest a high symptom burden and life challenges among chordoma patients and their caregivers. This study provides preliminary, limited estimates of the prevalence of a wide range of self-reported symptoms and challenges that will inform the assessment of patient-reported outcomes in future clinical trials and help clinicians better manage chordoma patients' symptoms.
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Cordoma/psicologia , Qualidade de Vida/psicologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Cuidadores , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
OBJECTIVES: To evaluate the reliability and factorial validity of the four-item Morisky Green Levine Medication Adherence Scale (MGLS) among Atherosclerosis Risk in Communities (ARIC) Study participants. METHODS: We used the cross-sectional visit 5 data from the ARIC Study to assess the measurement properties of the MGLS. We measured the internal consistency using Cronbach α (where α > 0.70 is considered reliable for group-level measurement), the response frequency, and the inter item correlation. Factor analysis of the MGLS and five other adherence items in the survey was conducted using a polychoric correlation matrix to examine the dimensionality that underlies the MGLS. A vanishing tetrad test was conducted to assess conformity with an effect indicator model. RESULTS: Among the ARIC visit 5 participants, 6,261 (96%) responded to the MGLS and other questions related to medication adherence in the survey (mean age 76 ± 5 years, 59% women). The Cronbach α for the MGLS was 0.47. The inter-item correlations ranged from 0.11 to 0.26. In the factor analysis of the medication adherence survey questions, a three-factor solution was used. One factor captured the extent of nonadherence, whereas other factors focused on the reasons for nonadherence. The MGLS items spread out across the factors that reflect the extent of as well as the reasons for nonadherence. The results of the vanishing tetrad test indicated that the MGLS consists of items other than effect indicators (P < 0.0001). CONCLUSIONS: The low reliability together with the factor analysis findings imply that the MGLS may reflect causes as well as the extent of medication adherence. The findings suggest that the MGLS, as presently used, lacks consistency in an elderly population.
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Adesão à Medicação/psicologia , Adesão à Medicação/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Anticolesterolemiantes/administração & dosagem , Fármacos Cardiovasculares/administração & dosagem , Estudos Transversais , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Masculino , Pessoa de Meia-Idade , Polimedicação , Psicometria , Reprodutibilidade dos Testes , Características de Residência/estatística & dados numéricos , Autorrelato , Fatores Socioeconômicos , Inquéritos e QuestionáriosRESUMO
IMPORTANCE: Reperfusion times for ST-elevation myocardial infarction (STEMI) occurring in outpatients have improved significantly, but quality improvement efforts have largely ignored STEMI occurring in hospitalized patients (inpatient-onset STEMI). OBJECTIVE: To define the incidence and variables associated with treatment and outcomes of patients who develop STEMI during hospitalization for conditions other than acute coronary syndromes (ACS). DESIGN, SETTING, AND PARTICIPANTS: Retrospective observational analysis of STEMIs occurring between 2008 and 2011 as identified in the California State Inpatient Database. EXPOSURES: STEMIs were classified as inpatient onset or outpatient onset based on present-on-admission codes. Patients who had a STEMI after being hospitalized for ACS were excluded from the analysis. MAIN OUTCOMES AND MEASURES: Regression models were used to evaluate associations among location of onset of STEMI, resource utilization, and outcomes. Adjustments were made for patient age, sex, comorbidities, and hospital characteristics. The analysis allowed for the location of inpatient STEMI to have a multiplicative rather than an additive effect for resource utilization since these measures were highly skewed. RESULTS: A total of 62,021 STEMIs were identified in 303 hospitals, of which 3068 (4.9%) occurred in patients hospitalized for non-ACS indications. Patients with inpatient-onset STEMI were older (mean, 71.5 [SD, 13.5] years vs 64.9 [SD, 14.1] years; P < .001) and more frequently female (47.4% vs 32%; P < .001) than those with outpatient-onset STEMI. Patients with inpatient-onset STEMI had higher in-hospital mortality (33.6% vs 9.2%; adjusted odds ratio (AOR), 3.05; 95% CI, 2.76-3.38; P < .001), were less likely to be discharged home (33.7% vs 69.4%; AOR, 0.38; 95% CI, 0.34-0.42; P < .001), and were less likely to undergo cardiac catheterization (33.8% vs 77.8%; AOR, 0.19; 95% CI, 0.16-0.21; P < .001) or percutaneous coronary intervention (21.6% vs 65%; AOR, 0.23; 95% CI, 0.21-0.26; P < .001). Length of stay and inpatient charges were higher for inpatient-onset STEMI (mean length of stay, 13.4 days [95% CI, 12.8-14.0 days] vs 4.7 days [95% CI, 4.6-4.8 days]; adjusted multiplicative effect, 2.51; 95% CI, 2.35-2.69; P < .001; mean inpatient charges, $245,000 [95% CI, $235,300-$254,800] vs $129,000 [95% CI, $127,900-$130,100]; adjusted multiplicative effect, 2.09; 95% CI, 1.93-2.28; P < .001). CONCLUSIONS AND RELEVANCE: Patients who had a STEMI while hospitalized for a non-ACS condition, compared with those with onset of STEMI as an outpatient, were less likely to undergo invasive testing or intervention and had a higher in-hospital mortality rate.
Assuntos
Mortalidade Hospitalar , Pacientes Internados , Infarto do Miocárdio/terapia , Pacientes Ambulatoriais , Intervenção Coronária Percutânea , Idoso , California/epidemiologia , Estudos de Coortes , Comorbidade , Feminino , Custos de Cuidados de Saúde , Serviços de Saúde/estatística & dados numéricos , Hospitalização/economia , Humanos , Incidência , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/economia , Infarto do Miocárdio/mortalidade , Razão de Chances , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Sexually transmitted infections (STIs) are among the most common causes of illness in the world and have far-reaching health, economic and social consequences for many countries. Failure to diagnose and treat STIs at an early stage may result in serious complications and sequels. OBJECTIVE: This study aimed to determine the prevalence of Chlamydia trachomatis infection in patients who remain symptomatic after completion of their first episode of treatment for STI. MATERIALS AND METHODS: We conducted a cross-sectional study on 49 patients suffering from symptoms or signs of sexually transmitted infections despite their first complete anti STI treatment. Conducting physical exam and smear preparation from vaginal discharge, diagnosis was confirmed by Polymerase chain reaction (PCR) method on every patient's first-voided urine sample. RESULTS: Among the etiologic factors investigated in this study, Chlamydia was reported in 17 patients. Trichomoniasis, Candidiasis, Gonorrhea and nonspecific germs were next organisms with 11, 9, 6 and 6 patients, respectively. Sixteen specimens were PCR positive (32.65%), while 33 patients had negative PCR results (67.34%) for Chlamydia trachomatis. CONCLUSION: Gonorrheal infection was the most prevalent infection in patients with completed treatment (6/10), which must be remembered in patients follow ups, because this prevalence warrants empirical therapy for Gonorrheain similar clinical conditions. Chlamydia trachomatis was the responsible organism in approximately a quarter of patients (17/75) who despite their full compliance on anti-Chlamydial treatment still suffered from signs and symptoms of STI. This rate also recommends empirical therapy for Chlamydia trachomatis in the similar clinical signs and symptoms.