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BACKGROUND: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection. OBJECTIVE: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone. DESIGN: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978). SETTING: Multinational, multicenter trial. PARTICIPANTS: Adults hospitalized with COVID-19. INTERVENTION: Intravenous ensovibep, 600 mg, or placebo. MEASUREMENTS: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90. RESULTS: An independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n = 247) or placebo (n = 238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P = 0.68; OR > 1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR > 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR < 1 would favor ensovibep). LIMITATION: The trial was prematurely stopped because of futility, limiting power for the primary outcome. CONCLUSION: Compared with placebo, ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; no safety concerns were identified. PRIMARY FUNDING SOURCE: National Institutes of Health.
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Tratamento Farmacológico da COVID-19 , Adulto , Proteínas de Repetição de Anquirina Projetadas , Método Duplo-Cego , Humanos , Proteínas Recombinantes de Fusão , SARS-CoV-2 , Resultado do TratamentoRESUMO
BACKGROUND: Medical educators need valid, reliable, and efficient tools to assess evidence-based medicine (EBM) knowledge and skills. Available EBM assessment tools either do not assess skills or are laborious to grade. OBJECTIVE: To validate a multiple-choice-based EBM test-the Resident EBM Skills Evaluation Tool (RESET). DESIGN: Cross-sectional study. PARTICIPANTS: A total of 304 medicine residents from five training programs and 33 EBM experts comprised the validation cohort. MAIN MEASURES: Internal reliability, item difficulty, and item discrimination were assessed. Construct validity was assessed by comparing mean total scores of trainees to experts. Experts were also asked to rate importance of each test item to assess content validity. KEY RESULTS: Experts had higher total scores than trainees (35.6 vs. 29.4, P < 0.001) and also scored significantly higher than residents on 11/18 items. Cronbach's alpha was 0.6 (acceptable), and no items had a low item-total correlation. Item difficulty ranged from 7 to 86%. All items were deemed "important" by > 50% of experts. CONCLUSIONS: The proposed EBM assessment tool is a reliable and valid instrument to assess competence in EBM. It is easy to administer and grade and could be used to guide and assess interventions in EBM education.
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Competência Clínica , Avaliação Educacional , Estudos Transversais , Medicina Baseada em Evidências , Humanos , Reprodutibilidade dos TestesRESUMO
Clinical decision-making relies heavily on making a correct diagnosis. Clinicians have a responsibility to understand the full spectrum of the diagnostic information conveyed by a physical exam finding, laboratory test result, or imaging. Many laboratory tests, such as troponin and B-type natriuretic peptide (BNP), are continuous tests with many possible results. Yet, there is a tendency to dichotomize tests into positive and negative, and use sensitivity and specificity to describe the test characteristics. This approach can lead to waste of important diagnostic information and substandard clinical decision-making. The aim of this paper is to demonstrate the role of ROC curves in developing a more comprehensive understanding of diagnostic information portrayed by continuous tests to augment clinical decision-making.
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Tomada de Decisão Clínica/métodos , Funções Verossimilhança , Curva ROC , Idoso , Testes Diagnósticos de Rotina/normas , Insuficiência Cardíaca/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Receptores do Fator Natriurético Atrial/sangue , Sensibilidade e Especificidade , Troponina/sangueRESUMO
OBJECTIVES: We sought to examine whether baseline diastolic dysfunction (DD) is associated with increased mortality in patients who develop aortic insufficiency (AI) after transcatheter aortic valve replacement (TAVR). BACKGROUND: Significant post-TAVR AI is associated with increased mortality, likely secondary to adverse hemodynamics secondary to volume overload and decreased LV compliance from chronic pressure overload. However, the effect of baseline DD on outcomes of patients with post-TAVR AI has not been studied. METHODS: A total of 195 patients undergoing TAVR were included in the study. Patients with moderate-to-severe mitral stenosis, prior mitral valve replacement or atrial fibrillation were excluded. DD was classified at baseline by a 2-step approach as recommended by the American Society of Echocardiography while AI was evaluated 30 days post-TAVR. Follow up data up to 2 years post-TAVR was used in survival analysis. RESULTS: Patients with severe baseline DD who developed ≥mild post-TAVR AI had increased mortality compared to all other patients (HR = 3.89, CI: 1.76-8.6, P = 0.001), which remained significant after adjusting for post-TAVR AI, pre-TAVR AI, baseline mitral regurgitation, ejection fraction, pulmonary artery pressure, creatinine clearance and history of stroke. CONCLUSIONS: Even mild post-TAVR AI may have a negative impact on outcomes of patients with underlying severe DD. © 2016 Wiley Periodicals, Inc.
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Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/terapia , Valva Aórtica , Cateterismo Cardíaco/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Disfunção Ventricular Esquerda/complicações , Função Ventricular Esquerda , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/métodos , Cateterismo Cardíaco/mortalidade , Diástole , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Estimativa de Kaplan-Meier , Masculino , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico por imagem , Disfunção Ventricular Esquerda/mortalidade , Disfunção Ventricular Esquerda/fisiopatologiaRESUMO
BACKGROUND: Paravalvular aortic regurgitation (PAR) remains a common complication following transcatheter aortic valve replacement (TAVR), and has been associated with increased mortality. Adverse left ventricular (LV) remodelling has been reported in patients with post-TAVR PAR, but the association between adverse LV remodeling and increased mortality remains unclear. The aim of the present study was to examine the association between PAR, LV remodeling and mortality following TAVR in a non-PARTNER (Placement of Aortic Transcatheter Valves) trial population. METHODS: A total of 195 patients that underwent TAVR was included in the study. The LV ejection fraction (LVEF), LV mass index (LVMI), LV internal dimension at systole (LVIDs) and diastole (LVIDd) were compared between patients with different degrees of PAR at baseline, and at one month and one year after TAVR. Survival analysis was performed for different degrees of PAR and LV remodeling. RESULTS: PAR ≥moderate was associated with increased mortality (HR 4.58 [1.80-11.63], p = 0.001), but PAR >mild was not. The LVIDd and LVIDs were persistently increased at one year after TAVR in patients with PAR >mild compared to those with PAR ≤mild (5.9 ± 0.8 cm versus 5.4 ± 0.7 cm, p = 0.02 and 4.4 ± 0.8 cm versus 3.9 ± 0.8, p = 0.03, respectively). The LVEF was improved similarly between the two groups at one year after TAVR (p = 0.1). Patients with PAR ≥moderate had significantly more adverse LV remodeling at one month after TAVR in terms of LVIDd, LVIDs, and LVMI. The degree of remodeling as expressed in terms of LVIDd, LVIDs, LVMI and LVEF changes from baseline did not have a direct impact on mortality. CONCLUSIONS: A worse PAR was associated with more adverse LV remodeling and a higher mortality after TAVR in a non-PARTNER patient population.
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Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/mortalidade , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Função Ventricular Esquerda , Remodelação Ventricular , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/fisiopatologia , Bases de Dados Factuais , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Modelos de Riscos Proporcionais , Recuperação de Função Fisiológica , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Volume Sistólico , Fatores de Tempo , Resultado do TratamentoAssuntos
Técnicas de Imagem por Elasticidade , Hepatite C , Cirrose Hepática , Fibrose , Humanos , VibraçãoRESUMO
In modern medical education, clinician-educators are increasingly called upon to develop online education to complement or replace in-person instruction. Despite a growing need for online curricula, many medical professionals lack training and experience in digital content development, deployment, assessment, and maintenance. Previous studies offer guidance on some aspects of online education development but often overlook key components, such as accessibility, legal considerations, financial implications, and sustainability challenges. This review offers medical professionals a broad overview of these important issues. We discuss various pedagogical considerations, including aligning educational goals and objectives with the digital content, choosing the appropriate online interface, and employing strategies to mitigate cognitive load while maximizing accessibility to create an inclusive online learning environment. We offer practical tips for creating effective, high-quality, and enduring audio-visual content and reflect on initial content deployment, testing, assessment, and revision. We discuss the intricacies of obtaining continuing medical education credits when the target audience includes faculty members. We address several legal issues online educators must consider, such as copyright laws, intellectual property rights, and medical liability. The review concludes with a discussion of sustainability mechanisms and financial considerations to ensure the long-term success of the educational program. Our recommendations aim to equip medical professionals embarking on a digital education journey with practical tools to produce effective, inclusive, and sustainable online content while considering legal implications.
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BACKGROUND: In response to a decline in bedside procedures performed by hospitalists, some hospital medicine groups have created medical procedure services (MPSs) concentrating procedures under the expertise of trained hospitalist-proceduralists. OBJECTIVES: To characterize the structure, breadth, and heterogeneity of academic medical center MPSs, as well as compare the procedural landscape for groups with and without an MPS. METHODS: The Survey of Internal Medicine Providers' Limitations and Experiences with Procedures and MPSs, is a cross-sectional study, conducted in the United States and Canada through a web-based survey administered from October 2022 to March 2023. We used convenience and snowball sampling to identify eligible study participants. The survey explored presence of MPS, procedure volumes, patient safety, and educational practices. For MPSs, we explored onboarding, staffing, skill maintenancy, funding, and barriers to growth. RESULTS: Forty instututions (response rate 97.5%), represented by members of the Procedural Research and Innovation for Medical Educators (PRIME) consortum participated in the survey. MPSs were found in 75% of the surveyed institutions. Most MPSs (97%) involved trainees and were staffed by internists (100%) who often had additional clinical duties (70%). The majority (83%) of MPSs used checklists and procedural safety guidelines, but only 53% had a standardized process for tracking complications. There was significant variability in determining procedural competency and supervising trainees. Groups with an MPS reported higher procedure volume compared to those without. CONCLUSIONS: MPSs were highly prevalent among the participating instutitions, offered a broad array of bedside procedures, and often included trainees. There was a high variability in funding models, procedure volumes, patient safety practices, and skill maintenance requirements.
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Importance: Burnout is a work-related syndrome of depersonalization (DP), emotional exhaustion (EE), and low personal achievement (PA) that is prevalent among internal medicine resident trainees. Prior interventions have had modest effects on resident burnout. The association of a new 4 + 4 block schedule (4 inpatient weeks plus 4 outpatient weeks) with resident burnout has not previously been evaluated. Objective: To evaluate the association of a 4 + 4 block schedule, compared with a 4 + 1 schedule, with burnout, wellness, and self-reported professional engagement and clinical preparedness among resident physicians. Design, Setting, and Participants: This nonrandomized preintervention and postintervention survey study was conducted in a single academic-based internal medicine residency program from June 2019 to June 2021. The study included residents in the categorical, hospitalist, and primary care tracks in postgraduate years 1 and 2 (PGY1 and PGY2). Data analysis was conducted from October to December 2022. Intervention: In the 4 + 4 structure, resident schedules alternated between 4-week inpatient call-based rotations and 4-week ambulatory non-call-based rotations. Main Outcomes and Measures: The primary outcome was burnout, assessed using the Maslach Burnout Inventory subcategories of EE (range, 0-54), DP (range, 0-30), and PA (range, 0-48), adjusted for sex and PGY. Secondary outcomes included In-Training Examination (ITE) scores and a questionnaire on professional, educational, and health outcomes. Multivariable logistic regression was used to assess the primary outcome, 1-way analysis of variance was used to compare ITE percentiles, and a Bonferroni-adjusted Kruskal Wallis test was used for the remaining secondary outcomes. The findings were reexamined with several sensitivity analyses, and Cohen's D was used to estimate standardized mean differences (SMDs). Results: Of the 313 eligible residents, 216 completed the surveys. A total of 107 respondents (49.5%) were women and 109 (50.5%) were men; 119 (55.1%) were PGY1 residents. The survey response rates were 78.0% (85 of 109) in the preintervention cohort and 60.6% (63 of 104) and 68.0% (68 of 100) in the 2 postintervention cohorts. The PGY1 residents had higher response rates than the PGY2 residents (119 of 152 [78.2%] vs 97 of 161 [60.2%]; P < .001). Adjusted EE scores (mean difference [MD], -6.78 [95% CI, -9.24 to -4.32]) and adjusted DP scores (MD, -3.81 [95% CI, -5.29 to -2.34]) were lower in the combined postintervention cohort. The change in PA scores was not statistically significant (MD, 1.4 [95% CI, -0.49 to 3.29]). Of the 15 items exploring professional, educational, and health outcomes, a large positive association was observed for 11 items (SMDs >1.0). No statistically significant change in ITE percentile ranks was noted. Conclusions and Relevance: In this survey study of internal medicine resident physicians, a positive association was observed between a 4 + 4 block training schedule and internal medicine resident burnout scores and improved self-reported professional, educational, and health outcomes. These results suggest that specific 4 + 4 block combinations may better improve resident burnout than a 4 + 1 combination used previously.
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Esgotamento Psicológico , Médicos Hospitalares , Testes Psicológicos , Masculino , Humanos , Feminino , Autorrelato , Capacitação em Serviço , Exaustão EmocionalRESUMO
The posthospital discharge period is vulnerable for patients with coronavirus disease 2019 (COVID-19). The authors implemented a COVID-19 discharge pathway in the electronic medical record for UCHealth, a 12-hospital health care system, including an academic medical center (University of Colorado Hospital [UCH]), to improve patient safety by standardizing discharge processes for COVID-19 patients. There were 3 key elements: (1) building consensus on discharge readiness criteria, (2) summarizing discharge criteria for disposition locations, and (3) establishing primary care follow-up protocols. The discharge pathway was opened 821 times between April 20, 2020, and June 7, 2020. Of the 436 patients discharged from the hospital medicine service at UCH from April 20, 2020, and June 7, 2020, 18 (4%) were readmitted and 13 (3%) had a 30-day emergency department visit. The main trend observed was venous thromboembolism. This pathway allowed real-time integration of clinical guidelines and complex disposition requirements, decreasing cognitive burden and standardizing care for a complex population.
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COVID-19/epidemiologia , Alta do Paciente/normas , Segurança do Paciente/normas , Centros Médicos Acadêmicos , Fatores Etários , Protocolos Clínicos , Comorbidade , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Mediadores da Inflamação/sangue , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Medição de Risco , SARS-CoV-2RESUMO
OBJECTIVES: The aim of the tutorial is to help educators address misconceptions about P values and provide a tool that can be used to teach a more contemporary interpretation. STUDY DESIGN AND SETTING: A scripted tutorial using problem-based learning and a diagnostic test analogy to deconstruct the misunderstandings about P values and develop a more Bayesian approach to study interpretation. RESULTS: A diagnostic test analogy is an effective teaching tool. Learners' understanding of Bayes' theorem in diagnostic testing can be used as a bridge to the realization that the prestudy probability of a true difference is crucial for study interpretation. The analogy has several caveats and shortcomings. The limitations of this analogy and the conceptual difficulties with the Bayesian study analyses are addressed. CONCLUSION: P values do not provide the information many assume they do-they are not equivalent to a probability of a chance finding. This tutorial helps move learners from these incorrect notions to new insights.
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Pesquisa Biomédica/normas , Tomada de Decisão Clínica , Interpretação Estatística de Dados , Testes Diagnósticos de Rotina/normas , Guias como Assunto , Probabilidade , Pesquisadores/educação , Adulto , Teorema de Bayes , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
OBJECTIVES: A subset of patients with coronavirus disease 2019 develop renal failure and require continuous renal replacement therapy. We reviewed the available literature to understand the frequency of continuous renal replacement therapy use among patients with coronavirus disease 2019 who required intensive care. DATA SOURCES: The authors reviewed PubMed and Google Scholar for published studies and MedRxiv.com for unpublished studies. STUDY SELECTION: Observational and randomized studies that report the frequency of continuous renal replacement therapy use in adult patients with coronavirus disease 2019. DATA EXTRACTION: Data from the eligible studies were extracted independently by two authors into Microsoft Excel. DATA SYNTHESIS: We identified 12 eligible studies (eight published, four unpublished). We found that up to 20% of patients admitted to ICUs may require continuous renal replacement therapy. CONCLUSIONS: Given the high utilization of continuous renal replacement therapy by critically ill patients with coronavirus disease 2019, there may be an urgent need to mobilize inpatient dialysis resources to cope with the anticipated increase in the demand.
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OBJECTIVES: This study aims to better understand and describe antibiotic prescribing practices and adherence to a procalcitonin (PCT)-guided algorithm in patients undergoing serum PCT testing in adult hospitalized patients. METHODS: We performed an observational, retrospective study of 201 randomly selected patients who are aged ≥18 years, admitted to the general medicine floors or step-down unit between 1 January 2017 and 31 December 2017, and had serum PCT testing. Physician adherence to a PCT-guided algorithm was assessed through chart review. RESULTS: We found an overall adherence of 64.7%. Adherence was highest for PCT values above 0.25 ng/mL (82.8% for 0.25-0.50 ng/mL and 83.6% for >0.50 ng/mL). Adherence was lower for PCT values less than 0.25 ng/mL (59% for <0.1 ng/mL and 38% for 0.1-0.24 ng/mL). Serial testing was performed in 10% of patients. CONCLUSIONS: Hospital-based providers are more likely to overrule the algorithm and either initiate or continue antibiotics when guidelines encourage discontinuing antibiotics. These findings have important implications for antimicrobial stewardship and patient care and suggest that hospital-based providers may benefit from targeted didactics regarding the interpretation of the serum PCT assay.
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Antibacterianos , Pró-Calcitonina , Adolescente , Adulto , Algoritmos , Antibacterianos/uso terapêutico , Biomarcadores , Hospitalização , Humanos , Estudos RetrospectivosRESUMO
BACKGROUND Point-of-care ultrasound (POCUS) is performed at the bedside by a healthcare professional who is directly caring for the patient. Subacute infective endocarditis can be challenging to diagnose, as patients often present with non-specific symptoms. The modified Duke criteria include echocardiographic findings as a major criterion, but the role of POCUS has not been established. This report is of a case of infective endocarditis diagnosed using POCUS. CASE REPORT A 57-year-old man was admitted to hospital with a presumptive diagnosis of rapidly progressive glomerulonephritis secondary to vasculitis associated with a non-specific rheumatologic condition that had developed during the previous three months. Several specialist physicians had previously examined him. On hospital admission, POCUS was performed by the internal medicine physician, which showed mitral valve endocarditis resulting in a change in clinical management from steroid therapy to antibiotic therapy. Blood cultures were performed, which grew Streptococcus mutans. CONCLUSIONS To our knowledge, this is the first reported case of infective endocarditis diagnosed by an internist using POCUS in a patient admitted to hospital with an alternative diagnosis and management plan in place. This case highlights the potential role of POCUS in the acute hospital setting and supports the need for studies to compare the diagnostic performance of POCUS with transthoracic echocardiography for the detection of valvular vegetations. POCUS may be considered for patients with a possible diagnosis of infective endocarditis that cannot be excluded using the modified Duke criteria, potentially resulting in earlier diagnosis and management, with an improved clinical outcome.
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Antibacterianos/uso terapêutico , Ecocardiografia Doppler/métodos , Endocardite Bacteriana/diagnóstico por imagem , Estenose da Valva Mitral/tratamento farmacológico , Sistemas Automatizados de Assistência Junto ao Leito , Acidente Vascular Cerebral/etiologia , Tratamento Conservador , Serviço Hospitalar de Emergência , Endocardite Bacteriana/complicações , Seguimentos , Glomerulonefrite/complicações , Glomerulonefrite/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Estenose da Valva Mitral/diagnóstico por imagem , Estenose da Valva Mitral/microbiologia , Multimorbidade , Doenças Reumáticas/complicações , Doenças Reumáticas/diagnóstico , Medição de Risco , Infecções Estreptocócicas/diagnóstico , Infecções Estreptocócicas/tratamento farmacológico , Streptococcus mutans/isolamento & purificação , Acidente Vascular Cerebral/terapia , Resultado do TratamentoRESUMO
Coronary artery fistula (CAF) is a rare anomalous connection between a coronary artery and another coronary artery, major vessel, or cardiac chamber. Prevalence of CAF is reportedly 1% to 2% in patients who undergo coronary angiography.1 One of the most common complications of CAF is formation of a coronary artery aneurysm (CAA). A study conducted by Said and colleagues in 1995 found that CAA formation was present in 26% of patients who had proven CAF by way of angiography.2 Although a precise definition of the term "giant" CAA is still lacking, it generally refers to a dilatation that exceeds the reference vessel diameter by four times.3 We report an interesting case of a 38-year-old patient who was incidentally found to have a presumed large right ventricular aneurysm, which after an open-heart surgery was identified as a CAF with formation of an unruptured giant CAA.