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Introduction: We wanted to characterize the evolution of the COVID-19 pandemic in a typical metropolitan area. Methods: Data were extracted from the Detroit COVID-19 Consortium database for hospitalized COVID-19 patients treated in Southeast Michigan over the 12-month period from March 2020 to February 2021. Demographic and outcomes data were compared to CDC data. Results: A total of 4,775 patients were enrolled during the study period. We divided the pandemic into three phases: Phase-1 (Spring Surge); Phase-2 (Summer Lull); and Phase-3 (Fall Spike). Changes in hydroxychloroquine, remdesivir, corticosteroid, antibiotic and anticoagulant use closely followed publication of landmark studies. Mortality in critically-ill patients decreased significantly from Phase-1 to Phase-3 (60.3% vs. 47.9%, Chisq p=0.0110). Monthly mortality of all hospitalized patients ranged between 14.8% - 21.5% during Phase-1 and 9.7 to 13.4% during Phase 3 (NS). Discussion: The COVID-19 pandemic presented in three unique phases in Southeast Michigan. Medical systems rapidly modified treatment plans, often preceding CDC and NIH recommendations. Despite improved treatment regimens, intubation rates and mortality for hospitalized patients remained elevated. Conclusion: Preventive measures aimed at reducing hospitalizations for COVID-19 should be emphasized.
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The purpose of the Aging Well Nursing-Interprofessional Salon was to explore current local community healthcare issues for older adults and to develop innovative strategies that support and enhance their health. An initiative emerged from the salon that focuses on identifying caregivers to ensure their awareness of available support resources. We are in the process of developing a pilot plan that includes collaboration of PhD and doctorate of nursing practice students, nursing faculty, and community agencies that support older adults.
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Cuidadores , Servicios de Salud Comunitaria , Servicios de Salud para Ancianos , Enfermeras Practicantes , Anciano , Femenino , Humanos , Masculino , MassachusettsRESUMEN
Aim: To estimate financial implications of adopting niraparib as maintenance treatment in recurrent ovarian cancer. Materials & methods: A model was developed to estimate the budget impact of treating patients with niraparib compared with alternative maintenance treatment options (olaparib, rucaparib, bevacizumab or 'watch and wait') over 3 years. Results: For a hypothetical plan with 1 million lives representative of US/Medicare-only populations, projected cost savings with niraparib were US$78,721/$293,723, $276,671/$1,009,729 and $353,585/$1,289,712 at years 1, 2 and 3, respectively. Sensitivity analyses showed prices of niraparib, rucaparib and olaparib to have the most significant impact on the budget. Conclusion: Factoring in all treatment-related costs, the use of niraparib could result in significant cost savings compared with other maintenance treatment options.
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Antineoplásicos/economía , Presupuestos , Carcinoma Epitelial de Ovario/economía , Indazoles/economía , Neoplasias Ováricas/economía , Piperidinas/economía , Inhibidores de Poli(ADP-Ribosa) Polimerasas/economía , Anciano , Antineoplásicos/uso terapéutico , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Ensayos Clínicos como Asunto , Costos de los Medicamentos , Sustitución de Medicamentos/economía , Femenino , Humanos , Indazoles/uso terapéutico , Indoles/economía , Indoles/uso terapéutico , Medicare/economía , Modelos Económicos , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/economía , Neoplasias Ováricas/tratamiento farmacológico , Ftalazinas/economía , Ftalazinas/uso terapéutico , Piperazinas/economía , Piperazinas/uso terapéutico , Piperidinas/uso terapéutico , Compuestos de Platino/economía , Compuestos de Platino/uso terapéutico , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Estados UnidosRESUMEN
INTRODUCTION: Unresectable, well-differentiated nonfunctioning gastroenteropancreatic neuroendocrine tumors (GEP-NETs) can be monitored (watchful waiting, WW) or treated with systemic therapy such as somatostatin analogues (SSAs) to delay progression. We applied a reflective multicriteria decision analysis (MCDA) shared-decision framework (previously developed for the USA) to explore what matters to Spanish patients and clinicians considering GEP-NET treatment options. METHODS: The EVIDEM-derived framework was updated and adapted to the Spanish context. During a Chatham House session, five patients and six physicians assigned criteria weights using hierarchical point allocation and direct rating scale (alternative analysis). Informed by synthesized evidence embedded in the framework, participants scored how each criterion favored SSA treatment (reference case lanreotide) or WW and shared insights and knowledge. Weights and scores were combined into value contributions (norm. weight × score/5), which were added across criteria to derive the relative benefit-risk balance (RBRB, scale - 1 to + 1). Exploratory comparisons to US study findings were performed. RESULTS: Focusing on intervention outcomes (effectiveness, patient-reported, and safety), the mean RBRB favored treatment over WW (+ 0.32 ± 0.24), with the largest contributions from progression-free survival (+ 0.11 ± SD 0.07), fatal adverse events (+ 0.06 ± SD 0.08), and impact on HRQoL (+ 0.04 ± SD 0.04). Consideration of modulating criteria (type of benefit, need, costs, evidence, and feasibility) increased the RBRB to + 0.50 ± 0.14, with type of therapeutic benefit (+ 0.10 ± SD 0.08) and quality of evidence (+ 0.08 ± SD 0.06) contributing most towards treatment. Alternative weighting yielded similar results. Results were broadly comparable to those derived from the US study. CONCLUSION: The multicriteria framework helped Spanish patients and clinicians identify and express what matters to them. The approach is transferable across decision-making contexts. FUNDING: IPSEN Pharma.
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Toma de Decisiones , Neoplasias Intestinales/terapia , Tumores Neuroendocrinos/terapia , Neoplasias Pancreáticas/terapia , Prioridad del Paciente , Somatostatina/uso terapéutico , Neoplasias Gástricas/terapia , Técnicas de Apoyo para la Decisión , Humanos , Neoplasias Intestinales/tratamiento farmacológico , Tumores Neuroendocrinos/tratamiento farmacológico , Neoplasias Pancreáticas/tratamiento farmacológico , Calidad de Vida , Medición de Riesgo , Neoplasias Gástricas/tratamiento farmacológicoRESUMEN
INTRODUCTION: Well- or moderately differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are often slow-growing, and some patients with unresectable, asymptomatic, non-functioning tumors may face the choice between watchful waiting (WW), or somatostatin analogues (SSA) to delay progression. We developed a comprehensive multi-criteria decision analysis (MCDA) framework to help patients and physicians clarify their values and preferences, consider each decision criterion, and support communication and shared decision-making. METHODS: The framework was adapted from a generic MCDA framework (EVIDEM) with patient and clinician input. During a workshop, patients and clinicians expressed their individual values and preferences (criteria weights) and, on the basis of two scenarios (treatment vs WW; SSA-1 [lanreotide] vs SSA-2 [octreotide]) with evidence from a literature review, expressed how consideration of each criterion would impact their decision in favor of either option (score), and shared their knowledge and insights verbally and in writing. RESULTS: The framework included benefit-risk criteria and modulating factors, such as disease severity, quality of evidence, costs, and constraints. Overall and progression-free survival being most important, criteria weights ranged widely, highlighting variations in individual values and the need to share them. Scoring and considering each criterion prompted a rich exchange of perspectives and uncovered individual assumptions and interpretations. At the group level, type of benefit, disease severity, effectiveness, and quality of evidence favored treatment; cost aspects favored WW (scenario 1). For scenario 2, most criteria did not favor either option. CONCLUSIONS: Patients and clinicians consider many aspects in decision-making. The MCDA framework provided a common interpretive frame to structure this complexity, support individual reflection, and share perspectives. FUNDING: Ipsen Pharma.
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Toma de Decisiones , Técnicas de Apoyo para la Decisión , Neoplasias Intestinales/terapia , Tumores Neuroendocrinos/terapia , Neoplasias Pancreáticas/terapia , Prioridad del Paciente , Neoplasias Gástricas/terapia , Comunicación , Gastos en Salud , Humanos , Supervivencia sin Progresión , Medición de Riesgo , Índice de Severidad de la Enfermedad , Somatostatina/análogos & derivados , Somatostatina/economía , Estados Unidos , Espera Vigilante/economía , Espera Vigilante/métodosRESUMEN
OBJECTIVES: Tackling ethical dilemmas faced by reimbursement decision makers requires deeper understanding of values on which health technology assessment (HTA) agencies are founded and how trade-offs are made. This was explored in this study including the case of rare disease. METHODS: Representatives from eight HTA explored values on which institutions are founded using a narrative approach and reflective multicriteria (developed from EVIDEM, criteria derived from ethical imperatives of health care). Trade-offs between criteria and the impact of incorporating defined priorities (including for rare diseases) were explored through a quantitative values elicitation exercise. RESULTS: Participants reported a diversity of substantive and procedural values with a common emphasis on scientific excellence, stakeholder involvement, independence, and transparency. Examining the ethical imperatives behind EVIDEM criteria was found to be useful to further explore substantive values. Most criteria were deemed to reflect institutions' values, while 70 percent of the criteria were reported by at least half of participants to be considered formally by their institutions. The quantitative values elicitation highlighted the difficulty to balance imperatives of "alleviating or preventing patient suffering," "serving the whole population equitably," "upholding healthcare system sustainability," and "making decisions informed by evidence and context" but may help share the ethical reasoning behind decisions. Incorporating "Priorities" (including for rare diseases) helped reveal trade-offs from other criteria and their underlying ethical imperatives. CONCLUSIONS: Reflective multicriteria are useful to explore substantive values of HTAs, reflect how these values and their ethical underpinnings can be operationalized into criteria, and explore the ethical reasoning at the heart of the healthcare debate.
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Toma de Decisiones , Enfermedades Raras/terapia , Evaluación de la Tecnología Biomédica/ética , Evaluación de la Tecnología Biomédica/organización & administración , Eficiencia Organizacional , Práctica Clínica Basada en la Evidencia , Asignación de Recursos para la Atención de Salud/ética , Asignación de Recursos para la Atención de Salud/normas , Humanos , Reembolso de Seguro de Salud/ética , Reembolso de Seguro de Salud/normas , Seguridad del Paciente , Índice de Severidad de la Enfermedad , Justicia Social/ética , Justicia Social/normas , Evaluación de la Tecnología Biomédica/normasRESUMEN
S. pneumoniae infection remains a serious public health concern despite the availability of vaccines covering up to 23 of more than 94 known serotypes. The purpose of the present study was to monitor recent serotype distribution data. PubMed, EMBASE, Cochrane Reviews and Ingenta databases were searched. Serotype data covering invasive pneumococcal disease (IPD) and non-IPD were extracted from articles published from March 2014 to March 2015. Fifty-nine studies presented pneumococcal serotype prevalence by specific age categories. Most prevalent serotypes not covered by pneumococcal conjugate vaccines (PCV) were as follows: 15B, 22F, 15A, 23A among children under the age of 7 y with IPD; among adults with IPD: 22F, 11A, 10A, 38 in the 65 y and older age group; 12F, 9N, 8 in the 50-64 year-old age group and 12F, 8, 6C, 16F in the 15-59 age group. Geographic variations in serotype distribution highlight the importance of monitoring evolving pneumococcal serotype prevalence after pneumococcal vaccine implementation.
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Infecciones Neumocócicas/epidemiología , Infecciones Neumocócicas/microbiología , Serogrupo , Streptococcus pneumoniae/clasificación , Streptococcus pneumoniae/aislamiento & purificación , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Salud Global , Humanos , Lactante , Persona de Mediana Edad , Prevalencia , Adulto JovenRESUMEN
Recent anticoagulants for stroke prevention in AF have been tested in active comparator controlled studies versus warfarin using two designs: double-blind, double-dummy and prospective randomised, open blinded endpoint (PROBE). The former requires elaborate procedures to maintain blinding, while PROBE does not. Outcomes of double-blind and PROBE designed studies of novel anticoagulants for AF, focusing on warfarin controls, were explored. Major, Phase III warfarin-controlled trials for stroke prevention in AF were identified. Odds ratios (ORs) of key outcomes for active comparators versus VKA and event rates for VKA arms were compared between designs, in context of baseline demographics and inclusion criteria. Identified trials studied five novel anticoagulants in three each of PROBE and double-blind design. For ORs of results across studies and outcomes, there was little pattern differentiating the two designs. Among VKA-control subjects, event rates for the primary outcome (stroke or systemic embolism) in PROBE trials at 1.74 %/year (95% confidence interval: 1.54-1.95) was not significantly different from that in double-blind trials, at 1.88 (1.73-2.03). Among other outcomes, VKA-treated subjects in both trial designs had similar event rates, apart from higher all-cause mortality in ROCKET AF, and lower myocardial infarction rates among the PROBE study patients. Although there are differences in outcome between PROBE and double blind trials, they do not appear to be design-related. The exacting requirements of double-blinding in AF trials may not be necessary.
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Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Accidente Cerebrovascular/prevención & control , Warfarina/uso terapéutico , Cardiología/métodos , Ensayos Clínicos Fase III como Asunto , Método Doble Ciego , Humanos , Infarto del Miocardio/prevención & control , Oportunidad Relativa , Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Resultado del Tratamiento , Vitamina K/antagonistas & inhibidores , Vitamina K/metabolismoRESUMEN
BACKGROUND: We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions. METHODS: Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957. FINDINGS: PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years. INTERPRETATION: No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis. FUNDING: Medtronic, Inc.
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Reestenosis Coronaria/etiología , Stents Liberadores de Fármacos/efectos adversos , Trombosis/etiología , Anciano , Enfermedad de la Arteria Coronaria/patología , Enfermedad de la Arteria Coronaria/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sirolimus/administración & dosificación , Sirolimus/análogos & derivadosRESUMEN
BACKGROUND: Prior studies demonstrate a direct relationship between treatment delays to primary percutaneous intervention and mortality in patients with ST-segment elevation myocardial infarction (STEMI). This analysis compared the relationship of symptom onset-to-balloon time and door-to-balloon time on mortality in patients with STEMI. METHODS AND RESULTS: We analyzed different treatment delays (symptom onset-to-balloon time, door-to-balloon time) and mortality in 5745 STEMI patients. Baseline characteristics, flow grade, 90-day mortality, and clinical outcomes were compared in patients stratified by treatment delay. Multivariable logistic regression modeling was performed to assess the independent and relative effect of each treatment delay on 90-day mortality. Female sex, increased age, and worse thrombolysis in myocardial infarction flow grade were significantly associated with longer symptom onset-to-balloon times and door-to-balloon times. Longer symptom onset-to-balloon time was significantly associated with worse 90-day mortality (3.7%, 4.2%, and 6.5% for time delays <3 hours, 3 to 5 hours, and >5 hours, respectively, P<0.0001). Similarly, longer door-to-balloon times were significantly associated with worse 90-day mortality (3.2%, 4.0%, 4.6%, and 5.3% for delays <60 minutes, 60 to 90 minutes, 90 to 120 minutes, and ≥120 minutes respectively, P<0.0001). In a multivariate model of 90-day mortality, door-to-balloon time (χ(2) 6.0, P<0.014), and symptom onset-to-hospital arrival (χ(2) 9.8, P<0.007) remained independent determinants. CONCLUSIONS: Both symptom onset-to-balloon time and hospital door-to-balloon time are strongly associated with 90-day mortality following STEMI. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00091637.
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Angioplastia Coronaria con Balón , Anticuerpos Monoclonales/uso terapéutico , Electrocardiografía , Infarto del Miocardio/mortalidad , Infarto del Miocardio/terapia , Anticuerpos de Cadena Única/uso terapéutico , Factores de Edad , Anciano , Anticuerpos Monoclonales Humanizados , Complemento C5/antagonistas & inhibidores , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores Sexuales , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Survival from ventricular tachycardia (VT) or ventricular fibrillation (VF) arrest is inversely related to delay to defibrillation. The automated external defibrillator (AED) has improved survival after out-of-hospital VT/VF arrest by decreasing time to defibrillation. The purpose of this study was to determine whether survival to discharge after in-hospital cardiac arrest caused by VT/VF could be improved via an institution-wide change from a standard monophasic defibrillator to a biphasic defibrillator with AED capability. METHODS AND RESULTS: After extensive staff education, all standard defibrillators were replaced by AEDs at a single institution. Outcomes were analyzed for 1 year before the change and 1 year after the change using a prospective database. In patients whose initial rhythm was VT/VF, AEDs were not associated with improvement in time to first shock (median 1 minute for both cohorts, p = 0.79) or survival to discharge (31% vs. 29%, p = 0.8) compared with standard defibrillators. In patients whose initial rhythm was asystole or pulseless electrical activity, AEDs were associated with a significant decrease in survival (15%) compared with standard defibrillators (23%, p = 0.04). The overall AED cohort showed no difference in survival to discharge compared with the standard cohort (18% vs. 23%, p = 0.09). CONCLUSIONS: Replacement of standard monophasic defibrillators with biphasic AEDs was associated with unchanged survival after in-hospital VT/VF arrest and decreased survival after in-hospital asystole or pulseless electrical activity arrest.
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Desfibriladores , Paro Cardíaco/mortalidad , Paro Cardíaco/terapia , Anciano , Femenino , Paro Cardíaco/etiología , Hospitalización , Humanos , Masculino , Tasa de Supervivencia , Taquicardia Ventricular/complicaciones , Taquicardia Ventricular/terapia , Fibrilación Ventricular/complicaciones , Fibrilación Ventricular/terapiaRESUMEN
Chronic myeloid leukemia (CML) in Asia has an incidence rather lower than in Western countries yet tends to afflict a younger population. As in the West, imatinib mesylate (IM, Glivec) has supplanted busulphan, hydroxyurea and interferon-alpha as first-line treatment. Its use has resulted in a dramatic decline in the number of hematopoietic stem cell transplantations (HSCT) performed. Although it is expensive, IM induces a complete cytogenetic response in 60-90% of newly diagnosed patients, and up to 10% for those in blastic phase. The standard dose of 400 mg is well tolerated by most patients, although adverse events have been observed, including drug-induced cytopenia. Through the Glivec International Patient Assistance Program, the majority of CML patients has access to IM and can expect prolonged survival, even in the absence of HSCT. However, just as in Western countries, resistance to imatinib has emerged in Asian countries. They will require the novel tyrosine kinase inhibitors (dasatinib, nilotinib) becoming available through either clinical trials or market approval. This review examines the available data on CML in China, Hong Kong, India, the Philippines, Singapore, South Korea, Taiwan and Thailand.
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Leucemia Mielógena Crónica BCR-ABL Positiva/tratamiento farmacológico , Leucemia Mielógena Crónica BCR-ABL Positiva/epidemiología , Asia/epidemiología , Resistencia a Antineoplásicos , Humanos , Inhibidores de Proteínas Quinasas/efectos adversos , Inhibidores de Proteínas Quinasas/uso terapéutico , Proteínas Tirosina Quinasas/antagonistas & inhibidores , Resultado del TratamientoRESUMEN
Adverse reactions to sulfonamides occur at a higher frequency in patients infected with the human immunodeficiency virus (HIV) than noninfected patients. Some studies have suggested that patients with the slow acetylator phenotype are predisposed to these reactions, whereas other studies suggest that the slow acetylator genotype is not a predisposing factor. To rationalize these seemingly contradictory observations, the authors determined the N-acetyltransferase 2 (NAT2) genotype and phenotype in patients with and without a history of hypersensitivity reactions to sulfonamides. HIV-infected patients with a history of a delayed-type hypersensitivity reaction to trimethoprim-sulfamethoxazole were enrolled, along with a group of AIDS patients with no history of hypersensitivity (delayed or immediate). NAT2 phenotype was determined in both groups using dapsone, while the genotype was determined using a polymerase chain reaction-restriction fragment length polymorphism assay. Ten of 14 patients (71%) with a history of hypersensitivity exhibited the slow acetylator phenotype, while 8 of 14 patients (57%) without such a history exhibited this same phenotype (odds ratio [OR] = 1.9, 95% confidence interval [CI] = 0.4-9.0; p = 0.69, Fisher's Exact Test). While 9 of 14 patients (64%) with a history of hypersensitivity exhibited a slow acetylator genotype, only 4 of 14 patients (29%) without such a history exhibited this genotype (ns). There were more instances of discordance between deduced and actual phenotype in the nonhypersensitive patients (n = 4) than in the hypersensitive patients (n = 1). The reported higher frequency of the slow acetylator phenotype among patients with a history of hypersensitivity to sulfonamides does not appear to be explained by metabolic changes that would cause discordance between acetylator genotype and phenotype.