RESUMO
PURPOSE: Oral anticoagulants effectively prevent stroke/systemic embolism among patients with non-valvular atrial fibrillation but remain under-prescribed. This study evaluated temporal trends in oral anticoagulant use, the incidence of stroke/systemic embolism and major bleeding, and economic outcomes among elderly patients with non-valvular atrial fibrillation and CHA2DS2-VASc scores ≥ 2. METHODS: Retrospective analyses were conducted on Medicare claims data from January 1, 2012 through December 31, 2017. Non-valvular atrial fibrillation patients aged ≥ 65 years with CHA2DS2-VASc scores ≥ 2 were stratified by calendar year (2013-2016) of care to create calendar-year cohorts. Patient characteristics were evaluated across all cohorts during the baseline period (12 months before diagnosis). Treatment patterns and clinical and economic outcomes were evaluated during the follow-up period (from diagnosis through 12 months). RESULTS: Baseline patient characteristics remained generally similar between 2013 and 2016. Although lack of oral anticoagulant prescriptions among eligible patients remained relatively high, utilization did increase progressively (53-58%). Among treated patients, there was a progressive decrease in warfarin use (79-52%) and a progressive increase in overall direct oral anticoagulant use (21-48%). There were progressive decreases in the incidence of stroke/systemic embolism 1.9-1.4 events per 100 person years) and major bleeding (4.6-3.3 events per 100 person years) as well as all-cause costs between 2013 and 2016. CONCLUSIONS: The proportions of patients with non-valvular atrial fibrillation who were not prescribed an oral anticoagulant decreased but remained high. We observed an increase in direct oral anticoagulant use that coincided with decreased incidence of clinical outcomes as well as decreasing total healthcare costs.
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Fibrilação Atrial , Embolia , Acidente Vascular Cerebral , Idoso , Humanos , Estados Unidos/epidemiologia , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/diagnóstico , Medicare , Estudos Retrospectivos , Anticoagulantes/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Hemorragia/tratamento farmacológico , Embolia/prevenção & controle , Custos de Cuidados de Saúde , Administração OralRESUMO
Oral anticoagulants (OACs) have been used to prevent stroke/systemic embolism (SE) among patients with non-valvular atrial fibrillation (NVAF). To evaluate baseline clinical characteristics, incidence rates of stroke/SE and hospitalization for bleeding, and OAC use among elderly patients with NVAF in the US by geographic region. Patients with NVAF were selected from the US Centers for Medicare & Medicaid Services claims database (01JAN2013-31DEC2016). Twelve months of health plan enrollment was required before and after the NVAF diagnosis to evaluate baseline characteristics and outcomes, respectively. Each patient was assigned to a 3-digit zip code based on their primary residence, and geographic variation was visualized using ArcGIS Pro software. Over 2.8 million patients with NVAF were identified. Large geographic variation was observed in clinical characteristics, stroke/SE, hospitalization for bleeding, and OAC use among patients across the US. The zip codes with the highest mean CHA2DS2-VASc scores and frequency of prior bleeding also had the highest incidence of stroke/SE and hospitalization for bleeding. Across 3-digit zip codes, 35-63% of patients were untreated. Overall, the incidence of stroke/SE and hospitalization for bleeding were higher and OAC treatment was less frequent in zip codes located in the Southern US. Baseline clinical characteristics, incidence rates of stroke/SE and hospitalization for bleeding, and OAC usage vary considerably by 3-digit zip code in the US. The additional granularity provided in this study may help clinicians to identify small regions with high-risk of stroke/SE and hospitalization for bleeding and low use of OAC that may benefit from targeted care strategies.
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Fibrilação Atrial , Embolia , Acidente Vascular Cerebral , Humanos , Idoso , Estados Unidos/epidemiologia , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Medicare , Anticoagulantes/uso terapêutico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/tratamento farmacológico , Embolia/induzido quimicamente , Administração Oral , Estudos RetrospectivosRESUMO
This study describes demographics, thrombotic and bleeding events, mortality, and anticoagulant use among hospitalized patients with COVID-19 in the United States. Premier Healthcare Database data were analyzed to identify inpatients with a discharge diagnosis for COVID-19 (ICD-10-CM code: U07.1) from April 1, 2020 to March 31, 2021, and matched historical controls without COVID-19 (inpatients discharged between April 1, 2018 and March 31, 2019). Thrombotic [including venous thromboembolism (VTE)] and bleeding events were based on ICD-10-CM discharge diagnosis codes. Of the 546,656 patients hospitalized with COVID-19, 20.1% were admitted to the ICU, 62.8% were aged ≥ 60 years, 51.5% were male, and 31.0% were non-white. Any thrombotic event was diagnosed in 10.0% of hospitalized and 20.8% of ICU patients with COVID-19 versus (vs) 11.5% and 24.4% for historical controls, respectively. More VTE events were observed in hospitalized and ICU patients with COVID-19 than historical controls (hospitalized: 4.4% vs 2.7%, respectively; ICU: 8.3% vs 5.2%, respectively; both P < 0.0001). Bleeding events were diagnosed in 10.2% of hospitalized and 21.8% of ICU patients with COVID-19 vs 16.0% and 33.2% for historical controls, respectively. Mortality among hospitalized (12.4%) and ICU (38.5%) patients with COVID-19 was higher vs historical controls (2.4%, P < 0.0001 and 9.4%, P < 0.0001, respectively) and higher in hospitalized patients with COVID-19 who had thrombotic events (29.4%) vs those without thrombotic events (10.8%, P < 0.0001). VTE and mortality were higher in hospitalized and ICU patients with COVID-19 vs historical controls. The presence of thrombotic events was associated with worse outcomes.
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COVID-19 , Trombose , Tromboembolia Venosa , Anticoagulantes/efeitos adversos , COVID-19/complicações , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Estudos Retrospectivos , Trombose/induzido quimicamente , Estados Unidos/epidemiologia , Tromboembolia Venosa/induzido quimicamente , Tromboembolia Venosa/epidemiologiaRESUMO
BACKGROUND: In 2007, WHO established the Guidelines Review Committee (GRC) to ensure that WHO guidelines adhere to the highest international standards. The GRC reviews guideline proposals and final guidelines. The objectives of this study were to examine the rates of and reasons for conditional approval and non-approval of documents submitted for the first time to the GRC, and calculate the time intervals and numbers of submissions to achieve approval for documents conditionally approved or not approved at first submission. METHODS: All initial submissions to the GRC between 2014 and 2017 were examined. Data were extracted from the GRC's records of written comments and discussions. RESULTS: Of a total of 85 proposals and 88 final guidelines, 32 (37.6%) proposals and 37 (42.0%) final guidelines were conditionally approved, and 15 (17.6%) proposals and 28 (31.8%) final guidelines were not. For both conditionally approved and not approved proposals, the most frequent reasons were suboptimal composition or inadequate description of the guideline contributor groups (in all proposals), followed by inadequate formulation of key questions (in 90.6% of conditionally approved proposals and all not approved proposals). For both conditionally approved and not approved final guidelines, the most frequent reasons were problems with recommendations (in all final guidelines), followed by inappropriate methods for evidence retrieval or an inadequate description thereof (in all conditionally approved final guidelines and 75.0% of not approved final guidelines). The median time to achieve approval was 2 months for proposals and 1-2 months for final guidelines. The median number of submissions was 2 for proposals and 2-2.5 for final guidelines. CONCLUSION: The GRC implements a rigorous quality assurance process and identifies problems with a significant percentage of initial submissions. WHO needs to continuously evaluate its guideline development processes to inform effective quality improvement measures and optimise the quality of its guidelines.
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Comitês Consultivos , Guias de Prática Clínica como Assunto , Garantia da Qualidade dos Cuidados de Saúde , Projetos de Pesquisa , Pesquisa Translacional Biomédica , Organização Mundial da Saúde , Estudos Transversais , Humanos , Cooperação InternacionalRESUMO
BACKGROUND: TKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated. METHODS AND FINDINGS: In this single-arm phase 2 trial, adults with laboratory-confirmed EVD received 0.3 mg/kg of TKM-130803 by intravenous infusion once daily for up to 7 d. On days when trial enrolment capacity was reached, patients were enrolled into a concurrent observational cohort. The primary outcome was survival to day 14 after admission, excluding patients who died within 48 h of admission. After 14 adults with EVD had received TKM-130803, the pre-specified futility boundary was reached, indicating a probability of survival to day 14 of ≤0.55, and enrolment was stopped. Pre-treatment geometric mean Ebola virus load in the 14 TKM-130803 recipients was 2.24 × 109 RNA copies/ml plasma (95% CI 7.52 × 108, 6.66 × 109). Two of the TKM-130803 recipients died within 48 h of admission and were therefore excluded from the primary outcome analysis. Of the remaining 12 TKM-130803 recipients, nine died and three survived. The probability that a TKM-130803 recipient who survived for 48 h will subsequently survive to day 14 was estimated to be 0.27 (95% CI 0.06, 0.58). TKM-130803 infusions were well tolerated, with 56 doses administered and only one possible infusion-related reaction observed. Three patients were enrolled in the observational cohort, of whom two died. CONCLUSIONS: Administration of TKM-130803 at a dose of 0.3 mg/kg/d by intravenous infusion to adult patients with severe EVD was not shown to improve survival when compared to historic controls. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201501000997429.
Assuntos
Antivirais/uso terapêutico , Ebolavirus/genética , Doença pelo Vírus Ebola/tratamento farmacológico , RNA Interferente Pequeno/uso terapêutico , RNA Viral/genética , Terapêutica com RNAi/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Ebolavirus/patogenicidade , Feminino , Doença pelo Vírus Ebola/diagnóstico , Doença pelo Vírus Ebola/genética , Doença pelo Vírus Ebola/mortalidade , Doença pelo Vírus Ebola/virologia , Interações Hospedeiro-Patógeno , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Nanopartículas , RNA Interferente Pequeno/administração & dosagem , RNA Viral/sangue , Terapêutica com RNAi/efeitos adversos , Serra Leoa , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento , Carga Viral/efeitos dos fármacos , Carga Viral/genética , Adulto JovemRESUMO
As of 20 May 2016 there have been 28,646 cases and 11,323 deaths resulting from the West African Ebola virus disease (EVD) outbreak reported to the World Health Organization. There continue to be sporadic flare-ups of EVD cases in West Africa.EVD presentation is nonspecific and characterized initially by onset of fatigue, myalgias, arthralgias, headache, and fever; this is followed several days later by anorexia, nausea, vomiting, diarrhea, and abdominal pain. Anorexia and gastrointestinal losses lead to dehydration, electrolyte abnormalities, and metabolic acidosis, and, in some patients, acute kidney injury. Hypoxia and ventilation failure occurs most often with severe illness and may be exacerbated by substantial fluid requirements for intravascular volume repletion and some degree of systemic capillary leak. Although minor bleeding manifestations are common, hypovolemic and septic shock complicated by multisystem organ dysfunction appear the most frequent causes of death.Males and females have been equally affected, with children (0-14 years of age) accounting for 19 %, young adults (15-44 years) 58 %, and older adults (≥45 years) 23 % of reported cases. While the current case fatality proportion in West Africa is approximately 40 %, it has varied substantially over time (highest near the outbreak onset) according to available resources (40-90 % mortality in West Africa compared to under 20 % in Western Europe and the USA), by age (near universal among neonates and high among older adults), and by Ebola viral load at admission.While there is no Ebola virus-specific therapy proven to be effective in clinical trials, mortality has been dramatically lower among EVD patients managed with supportive intensive care in highly resourced settings, allowing for the avoidance of hypovolemia, correction of electrolyte and metabolic abnormalities, and the provision of oxygen, ventilation, vasopressors, and dialysis when indicated. This experience emphasizes that, in addition to evaluating specific medical treatments, improving the global capacity to provide supportive critical care to patients with EVD may be the greatest opportunity to improve patient outcomes.
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Doença pelo Vírus Ebola , Adulto , África Ocidental/epidemiologia , Idoso , Cuidados Críticos/métodos , Cuidados Críticos/normas , Estado Terminal/mortalidade , Países em Desenvolvimento , Ebolavirus/patogenicidade , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
The largest ever Ebola virus disease outbreak is ravaging West Africa. The constellation of little public health infrastructure, low levels of health literacy, limited acute care and infection prevention and control resources, densely populated areas, and a highly transmissible and lethal viral infection have led to thousands of confirmed, probable, or suspected cases thus far. Ebola virus disease is characterized by a febrile severe illness with profound gastrointestinal manifestations and is complicated by intravascular volume depletion, shock, profound electrolyte abnormalities, and organ dysfunction. Despite no proven Ebola virus-specific medical therapies, the potential effect of supportive care is great for a condition with high baseline mortality and one usually occurring in resource-constrained settings. With more personnel, basic monitoring, and supportive treatment, many of the sickest patients with Ebola virus disease do not need to die. Ebola virus disease represents an illness ready for a paradigm shift in care delivery and outcomes, and the profession of critical care medicine can and should be instrumental in helping this happen.
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Cuidados Críticos/métodos , Doença pelo Vírus Ebola/terapia , Assistência ao Paciente/métodos , África Ocidental/epidemiologia , Estado Terminal , Surtos de Doenças/estatística & dados numéricos , Doença pelo Vírus Ebola/epidemiologia , Humanos , Cuidados Paliativos/métodosRESUMO
BACKGROUND: The objective of this study was to describe end-user impressions and experiences in a new intensive care unit built using evidence-based design. METHODS: This qualitative study was comprised of early (2-3 months after opening) and late (12-15 months after opening) phase individual interviews with end-users (healthcare providers, support staff, and patient family members) of the newly constructed Foothills Medical Centre intensive care unit in Calgary, Canada. The study unit was the recipient of the Society of Critical Care Medicine Design Citation award in 2012. RESULTS: We conducted interviews with thirty-nine ICU end-users, twenty-four in the early phase and fifteen in the late phase. We identified four themes (eleven sub-themes): atmosphere (abundant natural light and low noise levels), physical spaces (single occupancy rooms, rooms clustered into clinical pods, medication rooms, and tradeoffs of larger spaces), family participation in care (family support areas and social networks), and equipment (usability, storage, and providers connectivity). Abundant natural light was the design feature most frequently associated with a pleasant atmosphere. Participants emphasized the tradeoffs of size and space, and reported that the benefits of additional space (e.g., fewer interruptions due to less noise) out-weighed the disadvantages (e.g., greater distances between patients, families and providers). End-users advised that local patient care policies (e.g., number of visitors allowed at a time) and staffing needed to be updated to reflect the characteristics of the new facility design. CONCLUSIONS: End-users identified design elements for creating a pleasant atmosphere, attention to the tradeoffs of space and size, designing family support areas to encourage family participation in care, and updating patient care policies and staffing to reflect the new physical space as important aspects to consider when building intensive care units. Evidence-based design may optimize ICU structure for patients, patient families and providers.
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Atitude do Pessoal de Saúde , Projeto Arquitetônico Baseado em Evidências/normas , Família/psicologia , Arquitetura Hospitalar/normas , Unidades de Terapia Intensiva/normas , Satisfação Pessoal , Adulto , Alberta , Participação da Comunidade , Feminino , Humanos , Iluminação , Masculino , Pessoa de Meia-Idade , Ruído , Quartos de Pacientes/normas , Apoio SocialRESUMO
BACKGROUND: Although studies have suggested that a relationship exists between hospital teaching status and quality improvement activities, it is unknown whether this relationship exists for trauma centres. METHODS: We surveyed 249 adult trauma centres in the United States, Canada, Australia, and New Zealand (76% response rate) regarding their quality improvement programs. Trauma centres were stratified into two groups (teaching [academic-based or -affiliated] versus non-teaching) and their quality improvement programs were compared. RESULTS: All participating trauma centres reported using a trauma registry and measuring quality of care. Teaching centres were more likely than non-teaching centres to use indicators whose content evaluated treatment (18% vs. 14%, p < 0.001) as well as the Institute of Medicine aim of timeliness of care (23% vs. 20%, p < 0.001). Non-teaching centres were more likely to use indicators whose content evaluated triage and patient flow (15% vs. 18%, p < 0.001) as well as the Institute of Medicine aim of efficiency of care (25% vs. 30%, p < 0.001). While over 80% of teaching centres used time to laparotomy, pulmonary complications, in hospital mortality, and appropriate admission physician/service as quality indicators, only two of these (in hospital mortality and appropriate admission physician/service) were used by over half of non-teaching trauma centres. The majority of centres reported using morbidity and mortality conferences (96% vs. 97%, p = 0.61) and quality of care audits (94% vs. 88%, p = 0.08) while approximately half used report cards (51% vs. 43%, p = 0.22). CONCLUSIONS: Teaching and non-teaching centres reported being engaged in quality improvement and exhibited largely similar quality improvement activities. However, differences exist in the type and frequency of quality indicators utilized among teaching versus non-teaching trauma centres.
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Hospitais de Ensino/normas , Melhoria de Qualidade , Indicadores de Qualidade em Assistência à Saúde , Centros de Traumatologia/normas , Adulto , Austrália , Canadá , Coleta de Dados , Humanos , Nova Zelândia , Estados UnidosRESUMO
OBJECTIVES: Patient care rounds are a key mechanism by which healthcare providers communicate and make patient care decisions in the ICU but no synthesis of best practices for rounds currently exists. Therefore, we systematically reviewed the evidence for facilitators and barriers to patient care rounds in the ICU. DATA SOURCES: Search of Medline, Embase, CINAHL, PubMed, and the Cochrane library through September 21, 2012. STUDY SELECTION: Original, peer-reviewed research studies (no methodological restrictions) were selected, which described current practices, facilitators, or barriers to healthcare provider rounding in the ICU. DATA EXTRACTION: Two authors with methodological and content expertise independently abstracted data using a prespecified abstraction tool. DATA SYNTHESIS: The literature search identified 7,373 citations. Reviews of abstracts led to the retrieval of 136 full text articles for assessment; 43 articles in three languages (English, German, Spanish) were selected for review. Of these, 13 were ethnographic studies and 15 uncontrolled before-after studies. Six studies used control groups, including one cross-over randomized, one time-series, three cohort, and one controlled before-after study. A total of 13 facilitators and 9 barriers to patient care rounds were identified through a narrative and meta-synthesis of included studies. Identified facilitators suggest that the quality of rounds is improved when conducted by a multidisciplinary group of providers, with explicitly defined roles, using a standardized structure and goal-oriented approach that includes a best practices checklist. Barriers to quality patient care rounds include poor information retrieval and documentation, interruptions, long rounding times, and allied healthcare provider perceptions of not being valued by rounding physicians. CONCLUSIONS: Although the evidence base for best practices of patient care rounds in the ICU is limited, several practical and low-risk practices can be considered for implementation.
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Unidades de Terapia Intensiva , Visitas de Preceptoria/organização & administração , Acesso à Informação , Comunicação , Tomada de Decisões , Documentação , Medicina Baseada em Evidências , Objetivos , Humanos , Relações Interpessoais , Equipe de Assistência ao Paciente/organização & administração , Qualidade da Assistência à Saúde , Papel (figurativo)RESUMO
INTRODUCTION: In the USA, there is a steady rise of atrial fibrillation due to the aging population with increased morbidity. This study evaluated the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) among elderly patients with non-valvular atrial fibrillation (NVAF) and multimorbidity prescribed direct oral anticoagulants (DOACs). METHODS: Using the CMS Medicare database, a retrospective observational study of adult patients with NVAF and multimorbidity who initiated apixaban, dabigatran, or rivaroxaban from January 1, 2012 to December 31, 2017 was conducted. High multimorbidity was classified as having ≥ 6 comorbidities. Cox proportional hazard models were used to evaluate the hazard ratios of S/SE and MB among three 1:1 propensity score matched DOAC cohorts. All-cause healthcare costs were estimated using generalized linear models. RESULTS: Overall 36% of the NVAF study population had high multimorbidity, forming three propensity score matched (PSM) cohorts: 12,511 apixaban-dabigatran, 60,287 apixaban-rivaroxaban, and 12,567 dabigatran-rivaroxaban patients. Apixaban was associated with a lower risk of stroke/SE and MB when compared with dabigatran and rivaroxaban. Dabigatran had a lower risk of stroke/SE and a similar risk of MB when compared with rivaroxaban. Compared to rivaroxaban, apixaban patients incurred lower all-cause healthcare costs, and dabigatran patients incurred similar all-cause healthcare costs. Compared to dabigatran, apixaban patients incurred similar all-cause healthcare costs. CONCLUSION: Patients with NVAF and ≥ 6 comorbid conditions had significantly different risks for stroke/SE and MB when comparing DOACs to DOACs, and different healthcare expenses. This study's results may be useful for evaluating the risk-benefit ratio of DOAC use in patients with NVAF and multimorbidity.
Assuntos
Fibrilação Atrial , Embolia , Acidente Vascular Cerebral , Adulto , Humanos , Idoso , Estados Unidos/epidemiologia , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Rivaroxabana/efeitos adversos , Varfarina/uso terapêutico , Anticoagulantes/efeitos adversos , Dabigatrana/efeitos adversos , Multimorbidade , Medicare , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Medição de Risco , Piridonas/efeitos adversos , Administração OralRESUMO
BACKGROUND: Atrial fibrillation (AF) prevalence estimates vary and have been based on cohorts with clinically established or diagnosed disease. Undiagnosed AF prevalence estimates are less certain as they are based on nongeneralizable convenience samples. HYPOTHESIS: Because AF is often asymptomatic, it my remain undiagnosed until the development of complications such as stroke or heart failure. Consequently, the observed prevalence of diagnosed AF from the literature may underestimate total disease burden. We therefore sought to estimate the total prevalence of both diagnosed and undiagnosed AF. METHODS: We performed a retrospective cohort study from 2012 to 2017 using data from five US medical claims data sets. Undiagnosed AF prevalence was estimated based on the observed incidence of ischemic stroke, systemic embolism (SE), and AF incidence after a stroke/SE. The diagnosed AF cohort included AF patients between Q1 2014 and Q3 2015. The undiagnosed AF cohort were patients with assumed undiagnosed AF in the year before a stroke/SE and who were newly diagnosed with AF in the 3-month poststroke/SE. Stroke/SE incidence was calculated among all AF patients and the ratio of number of undiagnosed AF patients to stroke rate was created. Age- and sex-adjusted estimates were stratified by period of assumed undiagnosed AF before poststroke/SE AF diagnosis (1 or 2 years). RESULTS: The estimated US prevalence of AF (diagnosed and undiagnosed) in Q3 2015 was 5 628 000 cases, of which 591 000 cases (11%) were undiagnosed. The assumed 2-year undiagnosed AF prevalence was 23% (1 531 000) of the total prevalent patients with AF (6 568 000). Undiagnosed (vs. diagnosed) AF patients were older and had higher CHA2DS2-VASc scores. Of undiagnosed AF, 93% had CHA2DS2-VASc ≥2 and met OAC criteria. CONCLUSIONS: These contemporary estimates demonstrate the high prevalence of undiagnosed AF in the United States. Undiagnosed AF patients are composed of primarily elderly individuals who if diagnosed, would meet criteria for stroke prevention therapy.
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Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Estados Unidos/epidemiologia , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/complicações , Estudos Retrospectivos , Medição de Risco , Prevalência , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Anticoagulantes , Fatores de RiscoRESUMO
BACKGROUND: Patients with venous thromboembolism (VTE) and cancer are at higher risk of recurrent VTE and mortality. Clinical guidelines recommend anticoagulant treatment for these patients. This study assessed trends in outpatient anticoagulant treatment and factors associated with this treatment initiation in outpatient setting among this high-risk patient population. OBJECTIVE: To study trends and factors associated with anticoagulant treatment initiation among patients with VTE and cancer. METHODS: VTE cancer patients age ≥65 were identified from the SEER-Medicare database from 01JAN2014-31DEC2019. Patients were enrolled for ≥6 months prior to their first VTE (i.e. index event) and without evidence of other reasons for anticoagulation (i.e., atrial fibrillation). Patients were also required to be enrolled for ≥30 days after index. Cancer status was identified from SEER or Medicare database in the 6 months pre- through 30 days post-VTE. Patients were classified into treated or untreated cohorts depending on whether they initiated outpatient anticoagulant treatment within 30 days post-index. The trends of treated vs. untreated were evaluated by quarter. Logistic regression was used to identify demographic-, VTE-, cancer- and comorbid-related factors associated with anticoagulant treatment initiation. RESULTS: A total of 28,468 VTE-cancer patients met all study criteria. Of these, ~46 % initiated outpatient anticoagulant treatment within 30 days, and ~54 % did not. The above rates were stable from 2014 to 2019. Factors such as VTE diagnosis in inpatient setting, pulmonary embolism (PE) diagnosis, and pancreatic cancer were associated with increased odds whereas bleeding history and some comorbid factors were associated with decreased odds of initiating anticoagulant treatment. CONCLUSION: Over half of VTE patients with cancer did not initiate outpatient anticoagulant treatment within the first 30-days after VTE diagnosis. This trend was stable from 2014 to 2019. A range of cancer-, VTE-, and comorbid-related factors were associated with the likelihood of the treatment initiation.
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Neoplasias Pancreáticas , Tromboembolia Venosa , Humanos , Idoso , Estados Unidos , Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/complicações , Pacientes Ambulatoriais , Medicare , Fatores de Risco , Neoplasias Pancreáticas/complicaçõesRESUMO
Hispanic/Latino representation in medical research remains poor. We describe factors affecting rates of recruitment, participation, adherence, and retention of Hispanics/Latinos in clinical studies in the United States and characterize proposed strategies to improve these rates. A targeted literature review was conducted. Relevant studies were identified from Embase, MEDLINE®, and CENTRAL from January 1, 2010 to September 4, 2020. Sixty-eight studies were included. Key facilitators to research involvement were establishing trust between research staff and participants, incorporating familism, and using culturally appropriate language. Common elements of successful strategies for improving research involvement included incorporating community partners, bilingual and culturally competent research staff, continuous engagement and building relationships between participants and staff, and incorporating Hispanic/Latino cultural values. There is no universal strategy to improve research involvement of Hispanics/Latinos. The best strategy is likely a combination of key elements from several strategies, tailored to each unique study population. Further research is needed.
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Ensaios Clínicos como Assunto , Hispânico ou Latino , Estudos Observacionais como Assunto , Participação do Paciente , Humanos , Estados UnidosRESUMO
BACKGROUND: Oral anticoagulants (OACs) mitigate stroke risk in patients with atrial fibrillation (AF). The study aim was to analyze prevalence and predictors of OAC underutilization. METHODS: Newly diagnosed AF patients with a CHA2DS2-VASc score ≥ 2 were identified from the US CMS Database (January 1, 2013-December 31, 2017). Patients were stratified based on having an OAC prescription versus not and the OAC prescription group was stratified by direct OAC (DOACs) versus warfarin. Multivariable logistic regression models were used to examine predictors of OAC underutilization. RESULTS: Among 1,204,507 identified AF patients, 617,611 patients (51.3%) were not prescribed an OAC during follow-up (mean: 2.4 years), and 586,896 patients (48.7%) were prescribed an OAC during this period (DOAC: 388,629 [66.2%]; warfarin: 198,267 [33.8%]). Age ≥ 85 years (odds ratio [OR] 0.55, 95% confidence interval [CI] 0.55-0.56), female sex (OR 0.96, 95% CI 0.95-0.96), Black race (OR 0.78, 95% CI 0.77-0.79) and comorbidities such as gastrointestinal (GI; OR 0.43, 95% CI 0.41-0.44) and intracranial bleeding (OR 0.29, 95% CI 0.28-0.31) were associated with lower utilization of OACs. Furthermore, age ≥ 85 years (OR 0.92, 95% CI 0.91-0.94), Black race (OR 0.78, 95% CI 0.76-0.80), ischemic stroke (OR 0.77, 95% CI 0.75-0.80), GI bleeding (OR 0.73, 95% CI 0.68-0.77), and intracranial bleeding (OR 0.72, 95% CI 0.65-0.80) predicted lower use of DOACs versus warfarin. CONCLUSIONS: Although OAC therapy prescription is the standard of care for stroke prevention in AF patients, its overall utilization is still low among Medicare patients ≥ 65 years old, with specific patient characteristics that predict underutilization.
Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Feminino , Idoso , Estados Unidos/epidemiologia , Idoso de 80 Anos ou mais , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/complicações , Varfarina/uso terapêutico , Medicare , Anticoagulantes/uso terapêutico , Administração Oral , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Estudos RetrospectivosRESUMO
INTRODUCTION: This study evaluated the risk of hospitalization among nonvalvular atrial fibrillation (NVAF) patients with an outpatient COVID-19 diagnosis who discontinued vs continued apixaban treatment. METHODS: Adult patients with NVAF with an apixaban prescription prior to an outpatient COVID-19 diagnosis were identified from Optum Clinformatics claims database (1 April 2020-31 March 2021). Continuers were those who continued apixaban as of the index date (date of initial outpatient COVID-19 diagnosis) and discontinuers were those who had the last day of apixaban supply on or before index. Patients were followed from COVID-19 diagnosis to change of continuation/discontinuation status, switch, death, end of continuous coverage or study end, whichever occurred first. Inverse probability treatment weighting (IPTW) was performed to balance cohorts. Cox proportional hazard models were used to compare the risk of all-cause hospitalization and hospitalization for ischemic stroke (IS), venous thromboembolism (VTE), myocardial infarction (MI), bleeding and mortality. RESULTS: A total of 7869 apixaban patients with COVID-19 were included: 6676 continuers (84.8%) and 1193 discontinuers (15.2%). Compared with continuers, discontinuers had a higher risk of all-cause hospitalization (hazard ratio [HR]: 1.23; 95% confidence interval [CI]: 1.08-1.40), IS (HR: 2.00; 95% CI: 1.03-3.87), VTE (HR: 2.37; 95% CI: 1.06-5.27) and mortality (HR: 2.28; 95% CI: 1.85-2.80). There were no significant differences in the risk of MI (HR: 1.01; 95% CI: 0.54-1.90) or bleeding-related hospitalization (HR: 1.13; 95% CI: 0.73-1.76). CONCLUSION: NVAF patients with COVID-19 who discontinued apixaban had a higher risk of hospitalization and thrombotic events vs those who continued apixaban, with no significant difference in bleeding-related hospitalization.
Assuntos
Fibrilação Atrial , COVID-19 , Acidente Vascular Cerebral , Tromboembolia Venosa , Adulto , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Anticoagulantes , Teste para COVID-19 , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Estudos Retrospectivos , Piridonas/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/complicações , HospitalizaçãoRESUMO
BACKGROUND: Studies have shown that patients with non-valvular atrial fibrillation (NVAF) who discontinue oral anticoagulants (OACs) are at higher risk of complications such as stroke. OBJECTIVE: This analysis compared the risk of non-persistence with OACs among patients with NVAF. METHODS: Adult patients with NVAF who initiated apixaban, dabigatran, rivaroxaban, or warfarin were identified using 01JAN2013-30JUN2019 data from Centers for Medicare and Medicaid Services and four US commercial claims databases. Non-persistence was defined as discontinuation (no evidence of index OAC use for ≥ 60 days from the last days' supply) or switch to another OAC. Kaplan-Meier curves were generated to illustrate time to non-persistence along with cumulative incidences of non-persistence. Baseline and time-varying covariates were evaluated, and adjusted Cox proportional hazards models were used to evaluate non-persistence risk. RESULTS: In total, 363,823 patients receiving apixaban, 57,121 receiving dabigatran, 282,831 receiving rivaroxaban, and 317,337 receiving warfarin were included. Of these, 47-72% discontinued/switched OAC therapy within an average 9-month follow-up. Apixaban was associated with a lower risk of non-persistence than were dabigatran (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.61-0.62), rivaroxaban (HR 0.76; 95% CI 0.75-0.76), and warfarin (HR 0.74; 95% CI 0.74-0.75). Dabigatran was associated with a higher risk of non-persistence than were warfarin (HR 1.21; 95% CI 1.19-1.22) and rivaroxaban (HR 1.23; 95% CI 1.22-1.25), and rivaroxaban was associated with a lower risk of non-persistence than was warfarin (HR 0.98; 95% CI 0.97-0.98). Clinical events (stroke/systemic embolism and major bleeding [MB]) during follow-up were predictors of non-persistence (stroke HR 1.57; 95% CI 1.53-1.61; MB HR 2.96; 95% CI 2.92-3.00). CONCLUSION: In over one million patients with NVAF, our results suggest differences in anticoagulation treatment persistence across OAC agents, even after accounting for clinical events after OAC initiation. It is important for clinicians and patients to take these differences into consideration, especially as non-persistence to OAC therapy is associated with thromboembolic complications.
Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Administração Oral , Adulto , Idoso , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hemorragia/epidemiologia , Humanos , Medicare , Piridonas/efeitos adversos , Rivaroxabana/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Estados Unidos/epidemiologia , Varfarina/efeitos adversosRESUMO
Importance: The CHA2DS2-VASc score (calculated as congestive heart failure, hypertension, age 75 years and older, diabetes, stroke or TIA, vascular disease, age 65 to 74 years, and sex category) is the standard for assessing risk of stroke and systemic embolism and includes age and thromboembolic history. To our knowledge, no studies have comprehensively evaluated safety and effectiveness outcomes among patients with nonvalvular atrial fibrillation receiving oral anticoagulants according to independent, categorical risk strata. Objective: To evaluate the incidence of key adverse outcomes among patients with nonvalvular atrial fibrillation receiving oral anticoagulants by CHA2DS2-VASc risk score range, thromboembolic event history, and age group. Design, Setting, and Participants: This cohort study was a retrospective claims data analysis using combined data sets from 5 large health claims databases. Eligible participants were adult patients with nonvalvular atrial fibrillation who initiated oral anticoagulants. Data were analyzed between January 2012 and June 2019. Exposure: Initiation of oral anticoagulants. Main Outcomes and Measures: We observed clinical outcomes (including stroke or systemic embolism, major bleeding, and a composite outcome) on treatment through study end, censoring for discontinuation of oral anticoagulants, death, and insurance disenrollment. The population was stratified by CHA2DS2-VASc risk score; history of stroke, systemic embolism, or transient ischemic attack; and age groups. We calculated time to event, incidence rates, and cumulative incidence for outcomes. Results: We identified 1â¯141â¯097 patients with nonvalvular atrial fibrillation; the mean (SD) age was 75.0 (10.5) years, 608â¯127 patients (53.3%) were men, and over 1 million were placed in the 2 highest risk categories (high risk 1, 327â¯766 participants; high risk 2, 688â¯449 participants). Deyo-Charlson Comorbidity Index scores ranged progressively alongside CHA2DS2-VASc risk score strata (mean [SD] scores: low risk, 0.4 [1.0]; high risk 2, 4.1 [2.9]). The crude incidence of stroke and systemic embolism generally progressed alongside risk score strata (low risk, 0.25 events per 100 person-years [95% CI, 0.18-0.34 events]; high risk 2, 3.43 events per 100 person-years [95% CI, 3.06-4.20 events]); patients at the second-highest risk strata with thromboembolic event history had higher stroke incidence vs patients at the highest risk score strata without event history (2.06 events per 100 person-years [95% CI, 2.00-3.12 events] vs 1.18 events per 100 person-years [95% CI, 1.14-1.30 events]). Major bleeding and composite incidence also increased progressively alongside risk score strata (major bleeding: low risk, 0.68 events per 100 person-years [95% CI, 0.56-0.82 events]; high risk 2, 6.29 events per 100 person-years [95% CI, 6.21-6.62 events]; composite incidence: 1.22 events per 100 person-years [95% CI, 1.06-1.41 events]; high risk 2, 10.67 events per 100 person-years [95% CI, 10.26-11.48 events]). The 12-month cumulative incidence proportions for stroke and systemic embolism, major bleeding, and composite outcomes progressed alongside risk score strata (stroke or systemic embolism, 0.30%-1.85%; major bleeding, 0.55%-5.55%; composite, 1.05%-8.23%). Age subgroup analysis followed similar trends. Conclusions and Relevance: The observed incidence of stroke or systemic embolism and major bleeding events generally conformed to an expected increasing incidence by risk score, adding insight into the importance of specific risk score range, thromboembolic event history, and age group strata. These results can help inform clinical decision-making, research, and policy.