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Aim: To validate algorithms based on electronic health data to identify composition of lines of therapy (LOT) in multiple myeloma (MM). Materials & methods: This study used available electronic health data for selected adults within Henry Ford Health (Michigan, USA) newly diagnosed with MM in 2006-2017. Algorithm performance in this population was verified via chart review. As with prior oncology studies, good performance was defined as positive predictive value (PPV) ≥75%. Results: Accuracy for identifying LOT1 (N = 133) was 85.0%. For the most frequent regimens, accuracy was 92.5-97.7%, PPV 80.6-93.8%, sensitivity 88.2-89.3% and specificity 94.3-99.1%. Algorithm performance decreased in subsequent LOTs, with decreasing sample sizes. Only 19.5% of patients received maintenance therapy during LOT1. Accuracy for identifying maintenance therapy was 85.7%; PPV for the most common maintenance therapy was 73.3%. Conclusion: Algorithms performed well in identifying LOT1 - especially more commonly used regimens - and slightly less well in identifying maintenance therapy therein.
Electronic health data helps us understand treatment in the 'real world'. The data has great value in cancer if we can identify the drugs patients get. Yet this is hard in multiple myeloma (MM), where treatment is complex. Algorithms (set of decision rules) to identify drugs can help here. We tested an existing algorithm for identifying 'lines of therapy' (LOT) given to patients with MM. Each LOT included one or more drugs for MM. We also developed and tested a new algorithm for 'maintenance therapy'. This is a treatment given to help maintain the response to the main MM treatment. We tested how well the algorithms identified MM treatments in electronic health data. This data came from Henry Ford Health, a healthcare system in Michigan, USA. Treatments were confirmed by cancer specialists who reviewed medical charts. The LOT algorithm was good at finding the first LOT patients. The maintenance algorithm did a fair job of identifying the most used therapy. Our algorithms could help researchers study the real-world treatment of MM.
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Mieloma Múltiplo , Adulto , Humanos , Mieloma Múltiplo/diagnóstico , Mieloma Múltiplo/tratamento farmacológico , Valor Preditivo dos Testes , Algoritmos , Bases de Dados Factuais , Registros Eletrônicos de SaúdeRESUMO
Patients with thrombophilia remain concerned about venous thromboembolism (VTE) risk with COVID-19 vaccinations. The aim of this study was to examine VTE outcomes in patients with inherited or acquired thrombophilia who were vaccinated for COVID-19. Vaccinated patients ≥18 years between November 1, 2020 and November 1, 2021 were analyzed using electronic medical records across the Mayo Clinic enterprise. The primary outcome was imaging confirmed acute VTE occurring 90 days before and after the date of the first vaccine dose. Thrombophilia patients were identified through laboratory testing results and ICD-10 codes. A total of 792 010 patients with at least one COVID-19 vaccination were identified. Six thousand sixty-seven of these patients were found to have a thrombophilia, among whom there was a total of 39 VTE events after compared to 51 VTE events before vaccination (0.64% vs. 0.84%, p = .20). In patients with Factor V Leiden or prothrombin gene mutation, VTE occurred in 27 patients before and in 29 patients after vaccination (0.61 vs. 0.65%, p = .79). In patients with antiphospholipid syndrome, VTE occurred in six patients before and four patients after vaccination (0.59% vs. 0.39%, p = .40). No difference was observed in the overall VTE rate when comparing the postvaccination 90 days to the prevaccination 90 days, adjusted hazard ratio 0.81 (95% confidence interval: 0.53-1.23). In this subgroup of COVID-19 vaccinated patients with thrombophilia, there was no increased risk for acute VTE postvaccination compared to the prevaccination timeframe. These results are consistent with prior studies and should offer additional reassurance to patients with inherited or acquired thrombophilia.
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COVID-19 , Trombofilia , Tromboembolia Venosa , Humanos , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Vacinas contra COVID-19/efeitos adversos , COVID-19/complicações , COVID-19/prevenção & controle , Trombofilia/genética , Vacinação/efeitos adversos , Fatores de Risco , Fator V/genéticaRESUMO
BACKGROUND: COVID-19 caused by SARS-CoV-2 has infected 219 million individuals at the time of writing of this paper. A large volume of research findings from observational studies about disease interactions with COVID-19 is being produced almost daily, making it difficult for physicians to keep track of the latest information on COVID-19's effect on patients with certain pre-existing conditions. OBJECTIVE: In this paper, we describe the creation of a clinical decision support tool, the SMART COVID Navigator, a web application to assist clinicians in treating patients with COVID-19. Our application allows clinicians to access a patient's electronic health records and identify disease interactions from a large set of observational research studies that affect the severity and fatality due to COVID-19. METHODS: The SMART COVID Navigator takes a 2-pronged approach to clinical decision support. The first part is a connection to electronic health record servers, allowing the application to access a patient's medical conditions. The second is accessing data sets with information from various observational studies to determine the latest research findings about COVID-19 outcomes for patients with certain medical conditions. By connecting these 2 data sources, users can see how a patient's medical history will affect their COVID-19 outcomes. RESULTS: The SMART COVID Navigator aggregates patient health information from multiple Fast Healthcare Interoperability Resources-enabled electronic health record systems. This allows physicians to see a comprehensive view of patient health records. The application accesses 2 data sets of over 1100 research studies to provide information on the fatality and severity of COVID-19 for several pre-existing conditions. We also analyzed the results of the collected studies to determine which medical conditions result in an increased chance of severity and fatality of COVID-19 progression. We found that certain conditions result in a higher likelihood of severity and fatality probabilities. We also analyze various cancer tissues and find that the probabilities for fatality vary greatly depending on the tissue being examined. CONCLUSIONS: The SMART COVID Navigator allows physicians to predict the fatality and severity of COVID-19 progression given a particular patient's medical conditions. This can allow physicians to determine how aggressively to treat patients infected with COVID-19 and to prioritize different patients for treatment considering their prior medical conditions.
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COVID-19 , Sistemas de Apoio a Decisões Clínicas , Registros Eletrônicos de Saúde , Humanos , SARS-CoV-2 , SoftwareRESUMO
INTRODUCTION: Indications for apheresis procedures are expanding; however, the evidence for many is low quality. A better understanding of apheresis patterns in the United States is needed to better plan prospective research studies. METHODS: Data from January 1, 2013, to September 30, 2015, were analyzed from the IBM MarketScan Research Databases of de-identified health insurance claims data of several million enrollees at all levels of care from large employers and health plans across the United States. Apheresis procedures were identified by International Classification of Diseases, Ninth version (ICD-9) and Current Procedure Terminology (CPT) codes. RESULTS: Combining inpatients and outpatients, 18 706 patients underwent 70 247 procedures. The patients were 52.7% female, 5.1% <18 years, and 55.9% inpatient, while the procedures were 49.5% female, 5.7% <18 years, and 19.8% inpatient. For each apheresis modality, the percent of patients treated and procedures performed, respectively, are plasmapheresis 36.4% and 42.5%, autologous harvest of stem cells 22.8% and 10.7%, plateletpheresis 11.1% and 3.5%, allogeneic harvest of stem cells 8.2% and 2.5%, photopheresis 5.4% and 24.4%, erythrocytapheresis 3.8% and 4.7%, leukopheresis 2.0% and 0.7%, immunoadsorption 1.4% and 0.4%, extracorporeal selective adsorption/filtration and plasma reinfusion 1.0% and 3.6%, and other 21.6% and 6.9%. A wide variety of diagnoses were treated; however, analysis of the diagnoses suggests the procedure codes may not always reflect an apheresis procedure. CONCLUSION: This study describes the landscape of apheresis in the United States, but may overestimate some procedures based on linked diagnosis codes. Direct measures of apheresis procedures are needed to plan future research studies.
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Remoção de Componentes Sanguíneos/métodos , Adulto , Feminino , Humanos , Masculino , Fotoferese/métodos , Plasmaferese/métodos , Plaquetoferese/métodos , Padrões de Prática Médica , Estados UnidosAssuntos
Anemia Falciforme/patologia , Medula Óssea/patologia , Ativação do Complemento , Adulto , Anemia Falciforme/complicações , Anemia Falciforme/imunologia , Medula Óssea/imunologia , Proteínas do Sistema Complemento/imunologia , Humanos , Necrose/etiologia , Necrose/imunologia , Necrose/patologia , Adulto JovemRESUMO
AIM: The objective in this study was to assess the clinical and economic implications of the inclusion of rivaroxaban as a secondary prophylaxis in patients with chronic or symptomatic peripheral artery disease (PAD) in the United States (US). METHODS: A cost-consequence model was adapted to evaluate the economic impact of rivaroxaban plus aspirin in a hypothetical 1-million-member health plan. The model inputs were taken from multiple sources: efficacy and safety of rivaroxaban + aspirin vs. aspirin alone were abstracted from COMPASS and VOYAGER randomized clinical trials; the prevalence of chronic and symptomatic PAD and incidence rates of clinical events (major adverse cardiac events [MACE], major adverse limb events [MALE], and major bleeding), were abstracted from the analysis of claims data; healthcare costs of clinical events and wholesale acquisition costs for rivaroxaban were abstracted from the literature and Red Book, respectively (2022 USD). One-way sensitivity analyses and subgroup analyses were also conducted. RESULTS: Over one year, with a 5% uptake of rivaroxaban, the model estimated rivaroxaban + aspirin to reduce 21 MACE/MALE events in the PAD patient population. The reduction in these clinical events offsets the increased risk of major bleeding (16 additional events), demonstrating a positive health benefit of the rivaroxaban addition. These benefits led to a $0.27 incremental cost per member per month (PMPM) to a US plan. The major driver of the incremental cost was the cost of rivaroxaban. In a subgroup of patients with the presence of any high-risk factor (heart failure, diabetes, renal insufficiency, or history of vascular disease affecting two or more vascular beds), the incremental PMPM cost was $0.13. CONCLUSIONS: Rivaroxaban + aspirin was found to provide positive net clinical benefit on the annual number of MACE/MALE avoided, with a modest increase in the PMPM cost.
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Aspirina , Doença Arterial Periférica , Humanos , Estados Unidos , Aspirina/uso terapêutico , Rivaroxabana , Inibidores do Fator Xa/uso terapêutico , Quimioterapia Combinada , Hemorragia/induzido quimicamente , Doença Arterial Periférica/complicações , Inibidores da Agregação Plaquetária/uso terapêuticoRESUMO
BACKGROUND: Venous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes. This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation. METHODS: The SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a "Living Guideline" process model for the VTE prevention CDS system. DISCUSSION: The stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics. TRIAL REGISTRATION: Clinicaltrials.gov - NCT05628207. Prospectively registered 11/28/2022, https://classic. CLINICALTRIALS: gov/ct2/show/NCT05628207 .
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Lesões Encefálicas Traumáticas , Sistemas de Apoio a Decisões Clínicas , Tromboembolia Venosa , Humanos , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/etiologia , Lesões Encefálicas Traumáticas/complicações , Guias de Prática Clínica como Assunto , Ciência da Implementação , Fidelidade a DiretrizesRESUMO
BACKGROUND: In the 1990s, transjugular intrahepatic portosystemic shunts (TIPS) were performed using bare metal stents, and stent-induced hemolysis was a complication noted in 10% of patients. This was due to the mechanical stress created by turbulent flow from the uncovered interstices. Polytetrafluoroethylene (PTFE) stents came into regular use in the early 2000s becoming the standard equipment for TIPS placements, which are predominately covered. Due to this, stent-induced hemolysis has become a rare phenomenon. CASE PRESENTATION: We describe a case of TIPS-induced hemolysis in a 53-years-old Caucasian female patient without cirrhosis. The patient had a history of heterozygous factor 5 Leiden mutation and abnormal lupus anticoagulant profile with development of a portal vein thrombus. She had undergone previous TIPS placement complicated by a TIPS thrombosis 3 years after initial placement requiring venoplasty and extension of the stent. Within one month, the patient developed hemolytic anemia with extensive evaluation that did not yield an alternative cause. Due to temporal association and clinical symptoms, the hemolytic anemia was attributed to the recent TIPS revision. CONCLUSION: This particular case of TIPS-induced hemolysis in a patient who does not have cirrhosis has not been previously described in the literature. Our case highlights that TIPS-induced hemolysis should be considered in anyone who could have potential underlying red blood cell dysfunction, not just those with cirrhosis. Further, the case demonstrates an important point that mild hemolysis (i.e., not requiring blood transfusion) can likely be managed conservatively, without stent removal.
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Síndrome Antifosfolipídica , Derivação Portossistêmica Transjugular Intra-Hepática , Humanos , Feminino , Pessoa de Meia-Idade , Hemólise , Derivação Portossistêmica Transjugular Intra-Hepática/efeitos adversos , Cirrose Hepática/complicações , Veia PortaRESUMO
Importance: Systematic data on the association between anticancer therapies and thromboembolic events (TEEs) in patients with COVID-19 are lacking. Objective: To assess the association between anticancer therapy exposure within 3 months prior to COVID-19 and TEEs following COVID-19 diagnosis in patients with cancer. Design, Setting, and Participants: This registry-based retrospective cohort study included patients who were hospitalized and had active cancer and laboratory-confirmed SARS-CoV-2 infection. Data were accrued from March 2020 to December 2021 and analyzed from December 2021 to October 2022. Exposure: Treatments of interest (TOIs) (endocrine therapy, vascular endothelial growth factor inhibitors/tyrosine kinase inhibitors [VEGFis/TKIs], immunomodulators [IMiDs], immune checkpoint inhibitors [ICIs], chemotherapy) vs reference (no systemic therapy) in 3 months prior to COVID-19. Main Outcomes and Measures: Main outcomes were (1) venous thromboembolism (VTE) and (2) arterial thromboembolism (ATE). Secondary outcome was severity of COVID-19 (rates of intensive care unit admission, mechanical ventilation, 30-day all-cause mortality following TEEs in TOI vs reference group) at 30-day follow-up. Results: Of 4988 hospitalized patients with cancer (median [IQR] age, 69 [59-78] years; 2608 [52%] male), 1869 had received 1 or more TOIs. Incidence of VTE was higher in all TOI groups: endocrine therapy, 7%; VEGFis/TKIs, 10%; IMiDs, 8%; ICIs, 12%; and chemotherapy, 10%, compared with patients not receiving systemic therapies (6%). In multivariable log-binomial regression analyses, relative risk of VTE (adjusted risk ratio [aRR], 1.33; 95% CI, 1.04-1.69) but not ATE (aRR, 0.81; 95% CI, 0.56-1.16) was significantly higher in those exposed to all TOIs pooled together vs those with no exposure. Among individual drugs, ICIs were significantly associated with VTE (aRR, 1.45; 95% CI, 1.01-2.07). Also noted were significant associations between VTE and active and progressing cancer (aRR, 1.43; 95% CI, 1.01-2.03), history of VTE (aRR, 3.10; 95% CI, 2.38-4.04), and high-risk site of cancer (aRR, 1.42; 95% CI, 1.14-1.75). Black patients had a higher risk of TEEs (aRR, 1.24; 95% CI, 1.03-1.50) than White patients. Patients with TEEs had high intensive care unit admission (46%) and mechanical ventilation (31%) rates. Relative risk of death in patients with TEEs was higher in those exposed to TOIs vs not (aRR, 1.12; 95% CI, 0.91-1.38) and was significantly associated with poor performance status (aRR, 1.77; 95% CI, 1.30-2.40) and active/progressing cancer (aRR, 1.55; 95% CI, 1.13-2.13). Conclusions and Relevance: In this cohort study, relative risk of developing VTE was high among patients receiving TOIs and varied by the type of therapy, underlying risk factors, and demographics, such as race and ethnicity. These findings highlight the need for close monitoring and perhaps personalized thromboprophylaxis to prevent morbidity and mortality associated with COVID-19-related thromboembolism in patients with cancer.
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COVID-19 , Neoplasias , Tromboembolia Venosa , Humanos , Masculino , Idoso , Feminino , Tromboembolia Venosa/induzido quimicamente , Tromboembolia Venosa/epidemiologia , Anticoagulantes/uso terapêutico , Estudos de Coortes , Estudos Retrospectivos , Teste para COVID-19 , Fator A de Crescimento do Endotélio Vascular , SARS-CoV-2 , Neoplasias/complicações , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologia , Agentes de ImunomodulaçãoAssuntos
Linfo-Histiocitose Hemofagocítica/complicações , Osteonecrose/epidemiologia , Adolescente , Adulto , Idoso , Feminino , Necrose da Cabeça do Fêmur/diagnóstico por imagem , Necrose da Cabeça do Fêmur/epidemiologia , Necrose da Cabeça do Fêmur/etiologia , Humanos , Imageamento por Ressonância Magnética , Masculino , Osteonecrose/diagnóstico por imagem , Osteonecrose/etiologia , Prevalência , Estudos Retrospectivos , Tomografia Computadorizada por Raios X , Adulto JovemRESUMO
Autoimmune hemolytic anemia (AHIA) is the group of acquired autoimmune conditions resulting from the development of autologous antibodies directed against autologous red blood cell antigens resulting in red cell lysis. Beyond the presence, severity, and duration of hemolysis which can lead to symptomatic anemia, additional complications at presentation and during treatment require a high degree of clinical vigilance. These include among others cutaneous, thrombotic, renal disorders, and infectious disorders. Complications can be due to the presence of the pathologic antibody itself, the process of hemolysis, or attributed to treatment. Comprehensive management of AIHA requires awareness and assessment of complications at diagnosis, during, and following treatment.
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Anemia Hemolítica Autoimune , Transplante de Células-Tronco Hematopoéticas , Trombose , Anemia Hemolítica Autoimune/diagnóstico , Anemia Hemolítica Autoimune/etiologia , Anemia Hemolítica Autoimune/terapia , Eritrócitos , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Hemólise , HumanosRESUMO
OBJECTIVES: Recent trials of glucose-lowering drugs (GLDs) have drawn attention to renal outcomes. Our goal was to understand how patients with diabetic kidney disease (DKD) are treated in general practices in the United States. STUDY DESIGN: Retrospective cohort study using a national-level claims data set and electronic health records. METHODS: Patients (≥ 18 years) with type 2 diabetes, whose estimated glomerular filtration rates (eGFRs) were between 15 and 89 mL/min/1.73 m2 between 2016 and 2018, were selected. Use of different GLDs during a 12-month period was examined across all eGFR levels. RESULTS: Of the 25,486 sample patients, 69.2%, 18.9%, 9.6%, and 2.3% had an eGFR in the ranges of 60 to 89, 45 to 59, 30 to 44, and 15 to 29 mL/min/1.73 m2, respectively. Metformin was used by nearly 33% of patients with an eGFR of 30 to 44 mL/min/1.73 m2 and by 10% of patients with an eGFR less than 30 mL/min/1.73 m2. Less than 10% (across all eGFR levels) of patients used glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors. Use of insulin was more frequent among patients with a lower eGFR (P < .05). The findings were similar in subgroups with different hemoglobin A1c levels (< 7% and ≥ 7%). CONCLUSIONS: Real-world treatment of DKD in the United States is suboptimal. Inappropriate use of some GLD classes, especially in advanced DKD stages, was found along with lower than expected use of modern agents that are considered safe and effective to treat glycemic outcomes. Efforts may be needed to improve understanding of safety, glycemic efficacy, and overall clinical value of GLDs across DKD stages.
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Diabetes Mellitus Tipo 2 , Nefropatias Diabéticas , Inibidores do Transportador 2 de Sódio-Glicose , Glicemia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Nefropatias Diabéticas/tratamento farmacológico , Glucose/farmacologia , Glucose/uso terapêutico , Humanos , Rim , Estudos Retrospectivos , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêuticoRESUMO
Objective: To assess incidence of urinary tract infection (UTI) among patients with recent spinal cord injury (SCI) who initiated intermittent catheterization (IC).Design: Retrospective chart review.Setting: Two European SCI rehabilitation centers.Participants: Seventy-three consecutive patients with recent SCI who initiated IC.Outcome measures: Incidence of UTI, using six different definitions, each based on microbiology ± symptomatology ± mention of UTI . Rates were expressed in terms of numbers of UTIs per 100 patient-months (PMs). Attention was focused on first-noted UTI during the three-month follow-up, as assessed with each of the six definitions.Results: Fifty-eight percent of patients (n = 33) met ≥1 definitions for UTI during follow-up (rate: 31.5 UTIs per 100 PMs), ranging from 14% (5.3 per 100 PMs; definition requiring bacteriuria, pyuria, and presence of symptoms) to 45% (22.7 per 100 PMs; definition requiring "mention of UTI"). Ten cases were identified using the definition that required bacteriuria, pyuria, and symptoms, whereas definitions that required bacteriuria and either pyuria or symptoms resulted in the identification of 20-25 cases. Median time to UTI ranged from 42 days ("mention of UTI") to 81 days (definition requiring bacteriuria and ≥100 leukocytes/mm3).Conclusion: Depending on definition, 14% to 45% of patients with recent SCI experience UTI within three months of initiating IC. Definitions requiring bacteriuria and either pyuria or symptoms consistently identified about twice as many cases as those that required all three conditions. Standardizing definitions may help improve detection, treatment, and prevention of UTI within this vulnerable population.
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Bacteriúria , Piúria , Traumatismos da Medula Espinal , Infecções Urinárias , Cateterismo/efeitos adversos , Alemanha , Humanos , Incidência , Países Baixos , Piúria/complicações , Estudos Retrospectivos , Traumatismos da Medula Espinal/reabilitação , Cateterismo Urinário/efeitos adversos , Infecções Urinárias/diagnóstico , Infecções Urinárias/epidemiologia , Infecções Urinárias/etiologiaRESUMO
BACKGROUND: COVID-19 vaccinations in the United States are effective in preventing illness and hospitalization yet concern over post-vaccination venous thromboembolism (VTE) risk has led to vaccine hesitancy. METHODS: The aim of this study was to compare VTE rates before and after COVID-19 vaccination. COVID-19 vaccinated patients ≥18 years between November 1, 2020 through November 1, 2021 were analyzed using electronic medical records across the Mayo Clinic enterprise. The primary outcome was imaging confirmed acute VTE (upper or lower deep vein thrombosis or pulmonary embolism) occurring 90 days before and after the date of first vaccine dose. RESULTS: A total of 792 010 patients with at least one COVID-19 vaccination were identified (Pfizer, n = 452 950, Moderna, n = 290 607, and Janssen [Johnson & Johnson], n = 48 453). A total of 1565 VTE events occurred in the 90 days before (n = 772) and after (n = 793) COVID-19 vaccination. VTE post-vaccination occurred in 326 patients receiving Moderna (0.11%, incidence rate [IR] 4.58 per 1000p-years), 425 patients receiving Pfizer (0.09%, IR 3.84 per 1000p-years), and 42 receiving Janssen (0.09%, IR 3.56 per 1000p-years). Compared to the pre-vaccination timeframe, the adjusted hazard ratio (aHR) for VTE after the Janssen vaccination was 0.97 (95% confidence interval [CI] 0.63-1.50), aHR 1.02 (95% CI 0.87-1.19) for Moderna, and aHR 1.00 (95% CI 0.87-1.15) for Pfizer. CONCLUSION: In this large cohort of COVID-19 vaccinated patients, no increased risk for acute VTE post-vaccination was identified for the authorized vaccines in the United States.
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COVID-19 , Tromboembolia Venosa , Trombose Venosa , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , Vacinação/efeitos adversos , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Trombose Venosa/epidemiologia , Trombose Venosa/etiologia , Trombose Venosa/prevenção & controleRESUMO
OBJECTIVES: The COVID-19 pandemic stressed hospital operations, requiring rapid innovations to address rise in demand and specialized COVID-19 services while maintaining access to hospital-based care and facilitating expertise. We aimed to describe a novel hospital system approach to managing the COVID-19 pandemic, including multihospital coordination capability and transfer of COVID-19 patients to a single, dedicated hospital. METHODS: We included patients who tested positive for SARS-CoV-2 by polymerase chain reaction admitted to a 12-hospital network including a dedicated COVID-19 hospital. Our primary outcome was adherence to local guidelines, including admission risk stratification, anticoagulation, and dexamethasone treatment assessed by differences-in-differences analysis after guideline dissemination. We evaluated outcomes and health care worker satisfaction. Finally, we assessed barriers to safe transfer including transfer across different electronic health record systems. RESULTS: During the study, the system admitted a total of 1209 patients. Of these, 56.3% underwent transfer, supported by a physician-led System Operations Center. Patients who were transferred were older (P = 0.001) and had similar risk-adjusted mortality rates. Guideline adherence after dissemination was higher among patients who underwent transfer: admission risk stratification (P < 0.001), anticoagulation (P < 0.001), and dexamethasone administration (P = 0.003). Transfer across electronic health record systems was a perceived barrier to safety and reduced quality. Providers positively viewed our transfer approach. CONCLUSIONS: With standardized communication, interhospital transfers can be a safe and effective method of cohorting COVID-19 patients, are well received by health care providers, and have the potential to improve care quality.
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COVID-19 , Anticoagulantes/uso terapêutico , COVID-19/epidemiologia , Dexametasona/uso terapêutico , Humanos , Pandemias , SARS-CoV-2RESUMO
The ongoing coronavirus disease 2019 (COVID-19) pandemic has left patients with current or past history of cancer facing disparate consequences at every stage of the cancer trajectory. This comprehensive review offers a landscape analysis of the current state of the literature on COVID-19 and cancer, including the immune response to COVID-19, risk factors for severe disease, and impact of anticancer therapies. We also review the latest data on treatment of COVID-19 and vaccination safety and efficacy in patients with cancer, as well as the impact of the pandemic on cancer care, including the urgent need for rapid evidence generation and real-world study designs. SIGNIFICANCE: Patients with cancer have faced severe consequences at every stage of the cancer journey due to the COVID-19 pandemic. This comprehensive review offers a landscape analysis of the current state of the field regarding COVID-19 and cancer. We cover the immune response, risk factors for severe disease, and implications for vaccination in patients with cancer, as well as the impact of the COVID-19 pandemic on cancer care delivery. Overall, this review provides an in-depth summary of the key issues facing patients with cancer during this unprecedented health crisis.
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COVID-19/epidemiologia , Neoplasias/complicações , COVID-19/complicações , COVID-19/terapia , Humanos , Neoplasias/imunologia , Neoplasias/terapia , PandemiasRESUMO
OBJECTIVE: It was our aim to study the role of sediment cytology in a diagnostic evaluation of ovarian neoplasm. METHODS: The present study was conducted in the Department of Pathology, Jawaharlal Nehru Medical College, AMU, Aligarh, India, over a span of 22 months. Cytological smears were prepared by centrifuging the sediment of fluid from the bottom of a container in which surgical specimens were received. Smears were fixed in 95% ethyl alcohol and then stained using hematoxylin-eosin and Papanicolaou stains. The cytological results were compared with histological diagnosis, taking the latter as gold standard. RESULTS: Out of 54 lesions studied by sediment cytology, 22 lesions were labeled as benign, 26 lesions as malignant and 6 lesions were inconclusive. Final histological diagnoses labeled 24 lesions as benign and 30 lesions as malignant. Comparing the diagnosis of the cytology smear with the histological section, 44 out of 54 cases were concordant. A sensitivity, specificity and diagnostic accuracy of 90.3, 92.3 and 90.3% was achieved, respectively. CONCLUSION: Biopsy sediment cytology is a good complementary method to histopathology in the study of ovarian biopsy material. In developing countries like ours, where the facility of frozen section is not available at many centers, this simple and cheap technique can be of much help in rapid diagnosis.
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Técnicas Citológicas/métodos , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/patologia , Biópsia , Feminino , HumanosRESUMO
BACKGROUND: Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend triple therapy (TT) for chronic obstructive pulmonary disease (COPD) patients based on severity. TT utilization by severity is infrequently studied in real-world settings and may deviate significantly from current clinical recommendations. This study describes prescribing pathways to TT among patients with COPD in the United States. METHODS: This study analyzed Geisinger Health System electronic medical records from 1 January 2004 to 30 November 2016. Two retrospective cohorts of COPD patients were included: (1) incident COPD, and (2) incident TT users. COPD treatment patterns, including time to TT, were summarized. Time to TT was estimated using Kaplan-Meier methods. Predictors of the relative hazard for TT among incident COPD patients were estimated using Cox proportional hazards regressions. RESULTS: Incident COPD and TT cohorts included 57,141 and 8173 patients, respectively. TT was used by 9.6% of incident COPD patients. In the year before TT, 34.3% of incident TT patients received treatment combinations recommended before TT according to GOLD recommendations, which mainly included: long-acting muscarinic antagonists (LAMAs), long-acting beta agonists (LABAs) + LAMAs, and inhaled corticosteroids + LABAs. Among incident TT patients, median time from COPD diagnosis to TT exceeded 2 years. The hazard for TT over time was associated with lower forced expiratory volume in 1 s values, more frequent exacerbations, current/previous smoking, and comorbid lung conditions such as pulmonary vascular disease, acute respiratory failure, and lung cancer. About 15-20% of the incident TT patients stepped down to a one- or two-drug regimen. Median time to TT discontinuation or step-down were 2 and 9 months, respectively. CONCLUSION: The study has revealed discrepancies in the treatment of COPD patients between GOLD guidelines and actual clinical practices in the United States. Pathways to TT differed from recommended therapy regimes. Further studies are needed to understand barriers to the use of guideline-recommended TTs by healthcare providers.The reviews of this paper are available via the supplemental material section.
Assuntos
Corticosteroides/administração & dosagem , Agonistas Adrenérgicos beta/administração & dosagem , Antagonistas Muscarínicos/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Idoso , Estudos de Coortes , Preparações de Ação Retardada , Quimioterapia Combinada , Registros Eletrônicos de Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Estudos Retrospectivos , Índice de Gravidade de Doença , Estados UnidosRESUMO
Stent grafts are utilized to treat and exclude visceral arterial aneurysms while preserving flow through the vessel. Stent-associated thrombocytopenia is a rare complication not typically seen with modern stents. The following case describes the clinical presentation of stent kinking and consumptive coagulopathy. Stent-associated microangiopathic hemolytic anemia was inferred from protracted workup and exclusion of alternative diagnoses. Despite the risk of arterial puncture in the setting of profound thrombocytopenia, the patient was successfully treated with stent embolization with near immediate rebound in platelet count. This case report documents the presentation of rare stent-associated thrombocytopenia leading to challenging diagnostic evaluation and necessitating high-risk intervention.
Assuntos
Aneurisma/terapia , Embolização Terapêutica , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Doença Iatrogênica , Síndrome de Kasabach-Merritt/terapia , Artéria Esplênica , Stents , Idoso , Anemia Hemolítica/etiologia , Aneurisma/diagnóstico por imagem , Humanos , Síndrome de Kasabach-Merritt/diagnóstico por imagem , Síndrome de Kasabach-Merritt/etiologia , Masculino , Artéria Esplênica/diagnóstico por imagem , Trombocitopenia/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: Coronavirus disease 2019 (COVID-19) is associated with a hypercoagulable state. Limited data exist informing the relationship between anticoagulation therapy and risk for COVID-19 related hospitalization and mortality. METHODS: We evaluated all patients over the age of 18 diagnosed with COVID-19 in a prospective cohort study from March 4th to August 27th, 2020 among 12 hospitals and 60 clinics of M Health Fairview system (USA). We investigated the relationship between (1) 90-day anticoagulation therapy among outpatients before COVID-19 diagnosis and the risk for hospitalization and mortality and (2) Inpatient anticoagulation therapy and mortality risk. FINDINGS: Of 6195 patients, 598 were immediately hospitalized and 5597 were treated as outpatients. The overall case-fatality rate was 2â¢8% (n = 175 deaths). Among the patients who were hospitalized, the inpatient mortality was 13%. Among the 5597 COVID-19 patients initially treated as outpatients, 160 (2.9%) were on anticoagulation and 331 were eventually hospitalized (5.9%). In a multivariable analysis, outpatient anticoagulation use was associated with a 43% reduction in risk for hospital admission, HR (95% CI = 0.57, 0.38-0.86), p = 0.007, but was not associated with mortality, HR (95% CI=0.88, 0.50 - 1.52), p = 0.64. Inpatients who were not on anticoagulation (before or after hospitalization) had an increased risk for mortality, HR (95% CI = 2.26, 1.17-4.37), p = 0.015. INTERPRETATION: Outpatients with COVID-19 who were on outpatient anticoagulation at the time of diagnosis experienced a 43% reduced risk of hospitalization. Failure to initiate anticoagulation upon hospitalization or maintaining outpatient anticoagulation in hospitalized COVID-19 patients was associated with increased mortality risk. FUNDING: No funding was obtained for this study.