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INTRODUCTION: Teprotumumab is a novel monoclonal antibody used for treatment of thyroid eye disease (TED). To our knowledge, this is the second reported case of encephalopathy associated with teprotumumab therapy. CASE PRESENTATION: A 62-year-old White woman with a history of hypertension, Graves' disease, and thyroid eye disease presented with 1 week of intermittent altered mental status following her third teprotumumab infusion. Neurocognitive symptoms resolved following plasma exchange therapy. DISCUSSION: By using plasma exchange as first-line therapy, our patient had a shorter time course from diagnosis to symptom resolution than was reported in the previously published case. CONCLUSIONS: Clinicians should consider this diagnosis in patients with encephalopathy after teprotumumab infusion, and our experience suggests plasma exchange is an appropriate initial treatment. Proper counseling of this potential side effect is warranted for patients prior to starting teprotumumab to facilitate earlier detection and treatment.
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Encefalopatias , Doença de Graves , Oftalmopatia de Graves , Feminino , Humanos , Pessoa de Meia-Idade , Oftalmopatia de Graves/complicações , Oftalmopatia de Graves/tratamento farmacológico , Anticorpos Monoclonais Humanizados/efeitos adversos , Doença de Graves/complicações , Doença de Graves/diagnósticoRESUMO
This cross-sectional study evaluates representation of racial and ethnic groups underrepresented in medicine among students attending California medical schools based on whether the representation standard is calculated at the local, state, or national level.
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Grupos Raciais , Faculdades de Medicina , Humanos , Etnicidade , CaliforniaRESUMO
A critical component for health equity lies in the inclusion of structurally excluded voices, such as Filipina/x/o Americans (FilAms). Because filam invisibility is normalized, denaturalizing these conditions requires reimagining power relations regarding whose experiences are documented, whose perspectives are legitimized, and whose strategies are supported. in this community case study, we describe our efforts to organize a multidisciplinary, multigenerational, community-driven collaboration for FilAm community wellness. Catalyzed by the disproportionate burden of deaths among FilAm healthcare workers at the onset of the COVID-19 pandemic and the accompanying silence from mainstream public health leaders, we formed the Filipinx/a/o Community Health Association (FilCHA). FilCHA is a counterspace where students, faculty, clinicians, and community leaders across the nation could collectively organize to resist our erasure. By building a virtual, intellectual community that centers our voices, FilCHA shifts power through partnerships in which people who directly experience the conditions that cause inequities have leadership roles and avenues to share their perspectives. We used Pinayism to guide our study of FilCHA, not just for the current crisis State-side, but through a multigenerational, transnational understanding of what knowledges have been taken from us and our ancestors. By naming our collective pain, building a counterspace for love of the community, and generating reflections for our communities, we work toward shared liberation. Harnessing the collective power of researchers as truth seekers and organizers as community builders in affirming spaces for holistic community wellbeing is love in action. This moment demands that we explicitly name love as essential to antiracist public health praxis.
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COVID-19 , Equidade em Saúde , Humanos , Aprendizagem , Pandemias , Saúde Pública , Estados UnidosRESUMO
BACKGROUND: Thirty years ago, Gulf War (GW) veterans returned home with numerous health symptoms that have been associated with neurotoxicant exposures experienced during deployment. The health effects from these exposures have been termed toxic wounds. Most GW exposure-outcome studies utilize group analyses and thus individual fluctuations in symptoms may have been masked. This study investigates health symptom trajectories in the same veterans over 25 years. METHODS: Veterans were categorized into 5 a priori trajectory groups for each health symptom and Chronic Multisymptom Illness (CMI) clinical case status. Multinomial logistic regression models were used to investigate associations between these trajectories and neurotoxicant exposures. RESULTS: Results indicate that more than 21 Pyridostigmine Bromide (PB) pill exposure was associated with consistent reporting of fatigue, pain, and cognitive/mood symptoms as well as the development of six additional symptoms over time. Chemical weapons exposure was associated with both consistent reporting and development of neurological symptoms over time. Reported exposure to tent heater exhaust was associated with later development of gastrointestinal and pulmonary symptoms. Veterans reporting exposure to more than 21 PB pills were more than 8 times as likely to consistently meet the criteria for CMI over time. CONCLUSION: This study highlights the importance of the continued documentation of the health impacts experienced by GW veterans', their resulting chronic health symptoms, and the importance of exposure-outcome relationships in these veterans now 30 years post-deployment.
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Síndrome do Golfo Pérsico , Veteranos , Doença Crônica , Estudos de Coortes , Guerra do Golfo , Humanos , Síndrome do Golfo Pérsico/induzido quimicamente , Síndrome do Golfo Pérsico/epidemiologiaRESUMO
BACKGROUND: Initiatives to identify and intervene on patients' socioeconomic needs in the context of health care delivery are expanding. Little information has been compiled across studies on health care providers' knowledge, attitudes, beliefs, and behaviors (KABB) regarding socioeconomic risk screening and referral interventions. METHODS: We conducted a systematic scoping review of providers' KABB related to health care-based socioeconomic risk screening and referral interventions using several search engines. Included studies assessed health care providers' KABB about screening and interventions conducted in clinical settings. RESULTS: Of 14,757 studies evaluated, 53 were eligible for inclusion. Study designs were heterogeneous. Outcome measures included attitudes and beliefs (n = 42), provider behaviors (n = 35), and provider knowledge (n = 26). The majority of providers expressed positive attitudes toward addressing patients' socioeconomic risks. Participants endorsed concerns regarding insufficient knowledge and resources, time and workflow disruption, and potential negative impacts of screening and referral programs on relationships. Exposure to screening and referral programs led to increases in providers' positive attitudes, socioeconomic risk screening rates, and reported knowledge about intervention options. CONCLUSIONS: Participation in screening and referral programs seems to influence providers' perception of implementation barriers. Future research should explore providers' concerns about addressing identified risks.
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Encaminhamento e Consulta , Projetos de Pesquisa , Humanos , Fatores SocioeconômicosRESUMO
Acute myocardial infarction (MI) patients remain at high risk for recurrent events. Cholesterol efflux, mediated by apolipoprotein A-I, removes excess cholesterol from atherosclerotic plaque and transports it to the liver for excretion. Impaired cholesterol efflux is associated with higher cardiovascular (CV) event rates among both patients with stable coronary artery disease and recent MI. CSL112, a novel intravenous formulation of apolipoprotein A-I (human) derived from human plasma, increases cholesterol efflux capacity. AEGIS-II is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial investigating the efficacy and safety of CSL112 compared to placebo among high-risk acute MI participants. Eligibility criteria include ageâ¯≥â¯18 years with type 1 (spontaneous) MI, evidence of multivessel stable coronary artery disease, and presence of diabetes requiring pharmacotherapy, orâ¯≥2 of the following: ageâ¯≥â¯65 years, prior MI, or peripheral artery disease. A target sample of 17,400 participants will be randomized 1:1 to receive 4 weekly infusions of CSL112 6 g or placebo, initiated prior to or on the day of discharge and within 5 days of first medical contact. The primary outcome is the time to first occurrence of the composite of CV death, MI, or stroke through 90 days. Key secondary outcomes include the total number of hospitalizations for coronary, cerebral, or peripheral ischemia through 90 days and time to first occurrence of the composite primary outcome through 180 and 365â¯days. AEGIS-II will be the first trial to formally test whether enhancing cholesterol efflux can reduce the rate of recurrent major adverse CV events.
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Lipoproteínas HDL/uso terapêutico , Infarto do Miocárdio/terapia , Idoso , Isquemia Encefálica/prevenção & controle , Colesterol/metabolismo , Doença da Artéria Coronariana/metabolismo , Diabetes Mellitus/tratamento farmacológico , Método Duplo-Cego , Esquema de Medicação , Hospitalização/estatística & dados numéricos , Humanos , Isquemia/prevenção & controle , Lipoproteínas HDL/administração & dosagem , Lipoproteínas HDL/efeitos adversos , Fígado/metabolismo , Infarto do Miocárdio/prevenção & controle , Isquemia Miocárdica/prevenção & controle , Doenças Vasculares Periféricas/prevenção & controle , Placebos/uso terapêutico , Placa Aterosclerótica/metabolismo , Acidente Vascular Cerebral/prevenção & controle , Fatores de TempoRESUMO
OBJECTIVES: Telemedicine visits are an increasingly popular method of care for mild infectious complaints, including uncomplicated urinary tract infections (UTIs), and they are an important target for antimicrobial stewardship programs (ASPs) to evaluate quality of prescribing. In this study, we compared antimicrobial prescribing in a primary care network for uncomplicated UTIs treated through virtual visits and at in-office visits. DESIGN: Retrospective cohort study comparing guideline-concordant antibiotic prescribing for uncomplicated UTI between virtual visits and office visits. SETTING: Primary care network composed of 44 outpatient sites and a single virtual visit platform. PATIENTS: Adult female patients diagnosed with a UTI between January 1 and December 31, 2018. METHODS: Virtual visit prescribing was compared to office visit prescribing, including agent, duration, and patient outcomes. The health system ASP provides annual education to all outpatient providers regarding local antibiogram trends and prescribing guidelines. Guideline-concordant therapy was assessed based on the network's ASP guidelines. RESULTS: In total, 350 patients were included, with 175 per group. Patients treated for a UTI through a virtual visit were more likely to receive a first-line antibiotic agent (74.9% vs 59.4%; P = .002) and guideline-concordant duration (100% vs 53.1%; P < .001). Patients treated through virtual visits were also less likely to have a urinalysis (0% vs 97.1%; P < .001) or urine culture (0% vs 73.1%; P < .001) ordered and were less likely to revisit within 7 days (5.1% vs 18.9%; P < .001). CONCLUSIONS: UTI care through a virtual visit was associated with more appropriate antimicrobial prescribing compared to office visits and decreased utilization of diagnostic and follow-up resources.
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Gestão de Antimicrobianos , Infecções Urinárias , Adulto , Antibacterianos/uso terapêutico , Feminino , Humanos , Visita a Consultório Médico , Atenção Primária à Saúde , Estudos Retrospectivos , Infecções Urinárias/diagnóstico , Infecções Urinárias/tratamento farmacológicoRESUMO
OBJECTIVE: This analysis examined the relationship between Gulf War (GW) exposures and health symptoms reported in three time periods over 20 years in Ft. Devens Cohort veterans. METHODS: Repeated logistic regression models examined the association of exposures and health symptoms over time. Models included baseline age, active duty status, post-traumatic stress disorder status, sex, and time since deployment as covariates. RESULTS: Exposure to tent heaters was associated with increased odds of crying easily and muscle twitching. Exposure to pyridostigmine bromide (PB) pills was associated with increased odds of depression and fatigue. Exposure to the Khamisiyah sarin plume was associated with increased odds of trouble concentrating and crying easily. CONCLUSION: This longitudinal analysis demonstrated an association between neurotoxicant exposures and increased odds of cognitive/mood, fatigue, and neurological symptoms. In addition, most symptoms increased over time since deployment regardless of exposure.
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Neurotoxinas/efeitos adversos , Exposição Ocupacional/análise , Síndrome do Golfo Pérsico , Veteranos , Estudos de Coortes , Guerra do Golfo , Humanos , Estudos Longitudinais , Brometo de Piridostigmina/efeitos adversos , Sarina/efeitos adversosRESUMO
BACKGROUND: The identification of acutely ill patients at high risk for venous thromboembolism (VTE) may be determined clinically or by use of integer-based scoring systems. These scores demonstrated modest performance in external data sets. OBJECTIVES: To evaluate the performance of machine learning models compared to the IMPROVE score. METHODS: The APEX trial randomized 7513 acutely medically ill patients to extended duration betrixaban vs. enoxaparin. Including 68 variables, a super learner model (ML) was built to predict VTE by combining estimates from 5 families of candidate models. A "reduced" model (rML) was also developed using 16 variables that were thought, a priori, to be associated with VTE. The IMPROVE score was calculated for each patient. Model performance was assessed by discrimination and calibration to predict a composite VTE end point. The frequency of predicted risks of VTE were plotted and divided into tertiles. VTE risks were compared across tertiles. RESULTS: The ML and rML algorithms outperformed the IMPROVE score in predicting VTE (c-statistic: 0.69, 0.68 and 0.59, respectively). The Hosmer-Lemeshow goodness-of-fit P-value was 0.06 for ML, 0.44 for rML, and <0.001 for the IMPROVE score. The observed event rate in the lowest tertile was 2.5%, 4.8% in tertile 2, and 11.4% in the highest tertile. Patients in the highest tertile of VTE risk had a 5-fold increase in odds of VTE compared to the lowest tertile. CONCLUSION: The super learner algorithms improved discrimination and calibration compared to the IMPROVE score for predicting VTE in acute medically ill patients.
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Total ischemic time, which specifies the time from the onset of chest pain to initiation of reperfusion during percutaneous coronary intervention, consists of two intervals: symptom to door time and door to balloon time. A door to balloon time of 90 mins or less has become a quality-of-care metric in the management of ST elevation myocardial infarction (STEMI). While national efforts made by the American College of Cardiology (ACC) and American Heart Association (AHA) have curtailed in-hospital door to balloon time over the years, a reduction in pre-hospital symptoms to door time presents a challenge in modern interventional Cardiology. Early and complete revascularization has been associated with improved clinical outcomes in MI and strategies that may help reduce symptom to door time, and thus the total ischemic time, are crucial. Rapidly evolving ST-segment changes commonly develop prior to ischemia-related symptom onset, and are detectable even in patients with clinically unrecognized silent MIs. Therefore, a highly intelligent ischemia detection system that alerts patients of ST segment deviation may allow for rapid identification of acute coronary occlusion. The AngelMed Guardian® System is a cardiac activity monitoring and alerting system designed for rapid identification of intracardiac ST-segment changes among patients at a high risk for recurrent ACS events. This article reviews the clinical studies evaluating the design, safety and efficacy of the AngelMed Guardian System and discusses the clinical implications of the device.
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An elevated white blood cell (WBC) count is associated with an increased risk of ischemic events among acute coronary syndrome (ACS) patients, but the association between WBC count and bleeding in ACS patients is not well established. The aim of this analysis was to assess and compare the association between WBC count and the occurrence of short- and long-term bleeding and ischemic events. This was a post hoc analysis of the ATLAS ACS2-TIMI 51 trial. A subset of patients had a WBC count measurement at baseline (nâ¯=â¯14,231, 91.6%). Univariate and multivariable Cox proportional hazard models were constructed to determine if there is an association between WBC count at baseline and a composite outcome of Thrombolysis in Myocardial Infarction (TIMI) major and minor bleeds at 30 days and 1 year. Variables with a p <0.2 in the univariate analysis were included as potential parameters in the backward selection process A similar multivariable model was constructed to assess the association between WBC count and a composite ischemic endpoint of cardiovascular death, myocardial infarction and stroke. An increased risk of bleeding per a 1â¯×â¯109/L increase in WBC at baseline was observed at 30 days (Adjusted hazard ratio [HR] 1.08 95% confidence interval [CI] 1.01 to 1.17, pâ¯=â¯0.019) but not at 1 year (Adjusted HR 1.02 95% CI 0.97 to 1.08, pâ¯=â¯0.409). Additionally, an increased risk of ischemia per a 1â¯×â¯109/L increase in WBC at baseline was observed at 30 days (Adjusted HR 1.07, 95% CI: 1.03 to 1.12, pâ¯=â¯0.002) and at 1 year (Adjusted HR 1.05 95% CI 1.02 to 1.08, pâ¯=â¯0.001 at 1 year). In conclusion, a higher WBC count at baseline was associated with an increased risk of the composite bleeding endpoint by 30 days but not at 1 year. The association between WBC count and the risk of the composite ischemic endpoint was significant at 30 days and 1 year.
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Síndrome Coronariana Aguda/epidemiologia , Doenças Cardiovasculares/mortalidade , Hemorragia/epidemiologia , Leucocitose/epidemiologia , Infarto do Miocárdio/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Síndrome Coronariana Aguda/tratamento farmacológico , Idoso , Angina Instável/tratamento farmacológico , Angina Instável/epidemiologia , Inibidores do Fator Xa/uso terapêutico , Feminino , Humanos , Contagem de Leucócitos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio sem Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio sem Supradesnível do Segmento ST/epidemiologia , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/uso terapêutico , Modelos de Riscos Proporcionais , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana/uso terapêutico , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologiaRESUMO
Introduction: Approximately 25-30% of veterans deployed to Kuwait, 1990-91, report persistent multi-symptom Gulf War Illness (GWI) likely from neurotoxicant exposures. Photobiomodulation (PBM) in red/near-infrared (NIR) wavelengths is a safe, non-invasive modality shown to help repair hypoxic/stressed cells. Red/NIR wavelengths are absorbed by cytochrome C oxidase in mitochondria, releasing nitric oxide (increasing local vasodilation), and increasing adenosine tri-phosphate production. We investigated whether PBM applied transcranially could improve cognition, and health symptoms in GWI. Materials and Methods: Forty-eight (40 M) participants completed this blinded, randomized, sham-controlled trial using Sham or Real, red/NIR light-emitting diodes (LED) applied transcranially. Fifteen, half-hour transcranial LED (tLED) treatments were twice a week (7.5 weeks, in-office). Goggles worn by participant and assistant maintained blinding for visible red. Pre-/Post- testing was at Entry, 1 week and 1 month post- 15th treatment. Primary outcome measures were neuropsychological (NP) tests; secondary outcomes, Psychosocial Questionnaires, including PTSD. Results: Primary Analyses (all participants), showed improvement for Real vs. Sham, for Digit Span Forwards (p < 0.01); and a trend for Trails 4, Number/Letter Sequencing (p < 0.10). For secondary outcomes, Real group reported more improvement on the SF-36V Plus, Physical Component Score (p < 0.08). Secondary Analyses included only subjects scoring below norm (50%ile) at Entry, on specific NP test/s. Real and Sham improved at 1 week after 15th treatment; however, at 1 month, only those receiving Real improved further: Digit Span Total, Forwards and Backwards; Trails 4, Number/Letter Sequencing; California Verbal Learning Test-II, long delay free recall; Continuous Performance Test-II, False Alarm Rate; and Color-Word Interference, Stroop, Trial 3, Inhibition; Sham group worsened, toward Entry values. Only those with more post-traumatic stress disorder (PTSD) symptomatology at Entry, receiving Real, continued to have additional PTSD reduction at 1 month; Sham regressed. Conclusion: This study was underpowered (n = 48), with large heterogeneity at Entry. This likely contributed to significance or trend to significance, for only two of the NP tests (Digit Span Forwards; Trails 4, Number/Letter Sequencing) and only one general health measure, the SF-36V Plus, Physical Component Score. More subjects receiving Real, self-reported increased concentration, relaxation and sleep. Controlled studies with newer, transcranial LED home treatment devices are warranted; this is expected to increase enrollment. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT01782378.
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BACKGROUND: Prior randomized controlled trials (RCT) evaluating the optimal antithrombotic therapies for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) have not been powered to evaluate ischemic outcomes. We compared double therapy with oral anticoagulation (OAC) and a P2Y12 inhibitor to triple therapy with an OAC + dual antiplatelet therapy in patients with AF requiring PCI. METHODS: Using PRISMA guidelines, we searched for RCTs including patients with AF as an indication for OAC and undergoing PCI or medical management of acute coronary syndrome. The results were pooled using fixed-effects and random-effects models to estimate the overall effect of double therapy versus triple therapy on ischemic and bleeding outcomes. RESULTS: We identified four RCTs, comprising 10,238 patients (5,498 double therapy, 4,740 triple therapy). Trial-reported major adverse cardiovascular events were similar between double therapy and triple therapy (fixed effect model OR 1.09, 95% CI 0.94-1.26). However, stent thrombosis (61/5,496 double therapy vs. 33/4738 triple therapy; fixed effect model OR 1.57, 95% CI 1.02-2.40; number needed to treat with triple therapy = 242) favored triple therapy. Bleeding outcomes were less frequent with double therapy (746/5470 vs. 950/4710; fixed effect model OR 0.59, 95% CI 0.53-0.65; number needed to harm with triple therapy = 16), but with significant heterogeneity (Q = 8.33, p = .04; I2 = 64%), as were intracranial hemorrhages (19/5470 vs. 30/4710; fixed effect model OR 0.54, 95% CI 0.31-0.96). CONCLUSIONS: Double therapy in patients with AF requiring OAC following PCI or Acute coronary syndrome has a significantly better safety profile than triple therapy but may be associated with a modest increased risk of stent thrombosis.
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Síndrome Coronariana Aguda/terapia , Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Trombose Coronária/prevenção & controle , Fibrinolíticos/administração & dosagem , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Síndrome Coronariana Aguda/diagnóstico , Idoso , Anticoagulantes/efeitos adversos , Fibrilação Atrial/diagnóstico , Trombose Coronária/etiologia , Terapia Antiplaquetária Dupla , Feminino , Fibrinolíticos/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Resultado do TratamentoRESUMO
Acutely ill medical patients with cancer are at increased risk of venous thromboembolism (VTE). Thromboprophylaxis is recommended in the presence of cancer, but its safety is not known. The aim of this study was to assess the efficacy and safety of extended prophylaxis with betrixaban in cancer patients enrolled in the APEX trial. APEX was a randomized, double-blind trial comparing oral betrixaban 80 mg qd administered for 35-42 days with subcutaneous enoxaparin 40 mg qd administered for 10 ± 4 days. Patients with acute medical illness and a history of cancer or active cancer were eligible for inclusion. Primary efficacy outcome was VTE (composite of symptomatic VTE and asymptomatic proximal deep vein thrombosis); primary safety outcome was major bleeding. Of 7513 patients enrolled in the APEX trial, 959 patients (12.8%), 499 randomized to betrixaban and 460 to enoxaparin, had cancer. The primary efficacy outcome occurred in 5.7% of cancer patients treated with betrixaban and in 6.2% treated with enoxaparin (p = 0.95). No significant interaction according to the presence or absence of cancer was observed (p = 0.36). Major bleeding events occurred in 0.8% of patients in the betrixaban group and in 0% in the enoxaparin group (p = 0.13), with no significant interaction (p = 0.07). The composite of major and clinically relevant non-major bleeds was similar between the two groups (2.9% and 2.0%, respectively, RR 1.43, 95% CI 0.63-3.27). Betrixaban was similarly effective in the reduction of VTE among subjects with and without cancer. The incidence of major bleeding was similarly low.
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Benzamidas/administração & dosagem , Estado Terminal/terapia , Inibidores do Fator Xa/administração & dosagem , Neoplasias/tratamento farmacológico , Profilaxia Pós-Exposição/métodos , Piridinas/administração & dosagem , Trombose Venosa/tratamento farmacológico , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Benzamidas/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/diagnóstico , Humanos , Masculino , Neoplasias/diagnóstico , Piridinas/efeitos adversos , Trombose Venosa/diagnósticoRESUMO
Traditional statistical models allow population based inferences and comparisons. Machine learning (ML) explores datasets to develop algorithms that do not assume linear relationships between variables and outcomes and that may account for higher order interactions to make individualized outcome predictions. To evaluate the performance of machine learning models compared to traditional risk stratification methods for the prediction of major adverse cardiovascular events (MACE) and bleeding in patients with acute coronary syndrome (ACS) that are treated with antithrombotic therapy. Data on 24,178 ACS patients were pooled from four randomized controlled trials. The super learner ensemble algorithm selected weights for 23 machine learning models and was compared to traditional models. The efficacy endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. The safety endpoint was a composite of TIMI major and minor bleeding or bleeding requiring medical attention. For the MACE outcome, the super learner model produced a higher c-statistic (0.734) than logistic regression (0.714), the TIMI risk score (0.489), and a new cardiovascular risk score developed in the dataset (0.644). For the bleeding outcome, the super learner demonstrated a similar c-statistic as the logistic regression model (0.670 vs. 0.671). The machine learning risk estimates were highly calibrated with observed efficacy and bleeding outcomes (Hosmer-Lemeshow p value = 0.692 and 0.970, respectively). The super learner algorithm was highly calibrated on both efficacy and safety outcomes and produced the highest c-statistic for prediction of MACE compared to traditional risk stratification methods. This analysis demonstrates a contemporary application of machine learning to guide patient-level antithrombotic therapy treatment decisions.Clinical Trial Registration ATLAS ACS-2 TIMI 46: https://clinicaltrials.gov/ct2/show/NCT00402597. Unique Identifier: NCT00402597. ATLAS ACS-2 TIMI 51: https://clinicaltrials.gov/ct2/show/NCT00809965. Unique Identifier: NCT00809965. GEMINI ACS-1: https://clinicaltrials.gov/ct2/show/NCT02293395. Unique Identifier: NCT02293395. PIONEER-AF PCI: https://clinicaltrials.gov/ct2/show/NCT01830543. Unique Identifier: NCT01830543.
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Síndrome Coronariana Aguda , Fibrinolíticos/efeitos adversos , Hemorragia , Aprendizado de Máquina , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/epidemiologia , Idoso , Feminino , Fibrinolíticos/administração & dosagem , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Cardiovasculares , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de RiscoRESUMO
BACKGROUND: Among stented patients with atrial fibrillation, double therapy with a novel oral anticoagulant plus single antiplatelet therapy (SAPT) reduces bleeding or cardiovascular rehospitalizations compared with a vitamin K antagonist (VKA) based triple therapy regimen. A recent study demonstrated that apixaban based double therapy reduced bleeding compared with VKA based double therapy. However, it remains unknown whether rivaroxaban based double therapy is superior to a VKA based double therapy. METHODS: Patient with stented atrial fibrillation (n=2124) were randomized to 3 groups: rivaroxaban 15 mg od plus a P2Y12 inhibitor (Group 1, n=709); rivaroxaban 2.5 mg bid plus dual antiplatelet therapy (DAPT; Group 2, n=709); and warfarin plus DAPT (Group 3, n=706). Before randomization, subjects were stratified according to a prespecified duration of DAPT (1, 6, or 12 months). After the prespecified DAPT duration, subjects in Group 2 were switched to rivaroxaban 15 mg plus low dose aspirin, and those in Group 3 were switched to VKA plus low dose aspirin. The Wei, Lin, and Weissfeld time to multiple events method was used to compare the occurrence of all bleeding and cardiovascular rehospitalizations among subjects on a novel oral anticoagulant versus VKA based double therapy. RESULTS: A total of 906 subjects were prespecified to a 1 or 6 months DAPT duration and received at least one dose of study drug. Twenty subjects (3.3%) assigned to novel oral anticoagulant+SAPT, and 15 (5.1%) subjects assigned to VKA+SAPT experienced multiple rehospitalizations. In total, 124 (20.3%) events occurred among subjects on novel oral anticoagulant+SAPT compared with 87 (29.6%) among subjects on VKA+SAPT (hazard ratio=0.65 [95% CI, 0.45-0.93], P=0.008). CONCLUSIONS: Among stented patients with atrial fibrillation, rivaroxaban plus SAPT was superior to warfarin plus SAPT in lowering total bleeding and cardiovascular rehospitalization. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01830543.
Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Doença da Artéria Coronariana/terapia , Inibidores do Fator Xa/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Rivaroxabana/administração & dosagem , Stents , Vitamina K/antagonistas & inibidores , Varfarina/administração & dosagem , Administração Oral , Idoso , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico , Quimioterapia Combinada , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/administração & dosagem , Fatores de Risco , Rivaroxabana/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Varfarina/efeitos adversosRESUMO
BACKGROUND: Many antibiotics prescribed in the outpatient setting result from upper respiratory tract infections (URTIs); however, these infections are often viral. Virtual visits have emerged as a popular alternative to office visits for URTIs and may be an important target for antimicrobial stewardship programs. METHODS: This retrospective cohort study evaluated adult patients diagnosed with sinusitis treated within a single primary care network. The primary objective was to compare guideline-concordant diagnosis between patients treated via virtual visits vs in-office visits. Guideline-concordant bacterial sinusitis diagnosis was based on national guideline recommendations. Secondary objectives included comparing guideline-concordant antibiotic prescribing between groups and 24-hour, 7-day, and 30-day revisits. RESULTS: A total of 350 patients were included in the study, with 175 in each group. Patients treated for sinusitis were more likely to receive a guideline-concordant diagnosis in the virtual visit group (69.1% vs 45.7%; P < .001). Additionally, patients who completed virtual visits were less likely to receive antibiotics (68.6% vs 94.3%; P < .001). Guideline-concordant antibiotic selection was similar between groups (67.5% vs 64.8%; P = .641). The median duration of therapy in both groups was 10 days (P = .88). Patients completing virtual visits were more likely to revisit for sinusitis within 24 hours (8% vs 1.7%; P = .006) and within 30 days (14.9% vs 7.4%; P = .027). CONCLUSIONS: In adult patients presenting with sinusitis, care at a virtual visit was associated with an increase in guideline-concordant diagnosis and a decrease in antibiotic prescribing compared with in-office primary care visits. Virtual visit platforms may be a valuable tool for antimicrobial stewardship programs in the outpatient setting.