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INTRODUCTION: Decisions to prescribe opioids to patients depend on many factors, including illness severity, pain assessment, and patient age, race, ethnicity, and gender. Gender and sex disparities have been documented in many healthcare settings, but are understudied in inpatient general medicine hospital settings. OBJECTIVE: We assessed for differences in opioid administration and prescription patterns by legal sex in adult patient hospitalizations from the general medicine service at a large urban academic center. DESIGNS, SETTING, AND PARTICIPANTS: This study included all adult patient hospitalizations discharged from the acute care inpatient general medicine services at the University of California, San Francisco (UCSF) Helen Diller Medical Center at Parnassus Heights from 1/1/2013 to 9/30/2021. MAIN OUTCOME AND MEASURES: The primary outcomes were (1) average daily inpatient opioids received and (2) days of opioids prescribed on discharge. For both outcomes, we first performed logistic regression to assess differences in whether or not any opioids were administered or prescribed. Then, we performed negative binomial regression to assess differences in the amount of opioids given. We also performed all analyses on a subgroup of hospitalizations with pain-related diagnoses. RESULTS: Our study cohort included 48,745 hospitalizations involving 27,777 patients. Of these, 24,398 (50.1%) hospitalizations were female patients and 24,347 (49.9%) were male. Controlling for demographic, clinical, and hospitalization-level variables, female patients were less likely to receive inpatient opioids compared to male patents (adjusted OR 0.87; 95% CI 0.82, 0.92) and received 27.5 fewer morphine milligram equivalents per day on average (95% CI - 39.0, - 16.0). When considering discharge opioids, no significant differences were found between sexes. In the subgroup analysis of pain-related diagnoses, female patients received fewer inpatient opioids. CONCLUSIONS: Female patients were less likely to receive inpatient opioids and received fewer opioids when prescribed. Future work to promote equity should identify strategies to ensure all patients receive adequate pain management.
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OBJECTIVES: To evaluate the relationship between early IV fluid volume and hospital outcomes, including death in-hospital or discharge to hospice, in septic patients with and without heart failure (HF). DESIGN: A retrospective cohort study using logistic regression with restricted cubic splines to assess for nonlinear relationships between fluid volume and outcomes, stratified by HF status and adjusted for propensity to receive a given fluid volume in the first 6 hours. An ICU subgroup analysis was performed. Secondary outcomes of vasopressor use, mechanical ventilation, and length of stay in survivors were assessed. SETTING: An urban university-based hospital. PATIENTS: A total of 9613 adult patients were admitted from the emergency department from 2012 to 2021 that met electronic health record-based Sepsis-3 criteria. Preexisting HF diagnosis was identified by the International Classification of Diseases codes. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: There were 1449 admissions from patients with HF. The relationship between fluid volume and death or discharge to hospice was nonlinear in patients without HF, and approximately linear in patients with HF. Receiving 0-15 mL/kg in the first 6 hours was associated with lower likelihood of death or discharge to hospice compared with 30-45 mL/kg (odds ratio = 0.61; 95% CI, 0.41-0.90; p = 0.01) in HF patients, but no significant difference for non-HF patients. A similar pattern was identified in ICU admissions and some secondary outcomes. Volumes larger than 15-30 mL/kg for non-HF patients and 30-45 mL/kg for ICU-admitted non-HF patients were not associated with improved outcomes. CONCLUSIONS: Early fluid resuscitation showed distinct patterns of potential harm and benefit between patients with and without HF who met Sepsis-3 criteria. Restricted cubic splines analysis highlighted the importance of considering nonlinear fluid outcomes relationships and identified potential points of diminishing returns (15-30 mL/kg across all patients without HF and 30-45 mL/kg when admitted to the ICU). Receiving less than 15 mL/kg was associated with better outcomes in HF patients, suggesting small volumes may be appropriate in select patients. Future studies may benefit from investigating nonlinear fluid-outcome associations and a focus on other conditions like HF.
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Hidratação , Insuficiência Cardíaca , Sepse , Humanos , Estudos Retrospectivos , Masculino , Feminino , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/mortalidade , Idoso , Pessoa de Meia-Idade , Hidratação/métodos , Sepse/mortalidade , Sepse/terapia , Estudos de Coortes , Mortalidade Hospitalar , Unidades de Terapia Intensiva , Tempo de InternaçãoRESUMO
Inpatient pain management is challenging for clinicians and inequities are prevalent. We examined sex concordance between physicians and patients to determine if discordance was associated with disparate opioid prescribing on hospital discharge. We examined 15,339 hospitalizations from 2013 to 2021. Adjusting for patient, clinical, and hospitalization-level characteristics, we calculated the odds of a patient receiving an opioid on discharge and the days of opioids prescribed across all hospitalizations and for patients admitted with a common pain diagnosis. We did not find an overall association between physician-patient sex concordance and discharge opioid prescriptions. Compared to concordant sex pairs, patients in discordant pairs were not significantly less likely to receive an opioid prescription (odds ratio: 1.04; 95% confidence interval [CI]: 0.95, 1.15) and did not receive significantly fewer days of opioids (2.1 fewer days of opioids; 95% CI: -4.4, 0.4). Better understanding relationships between physician and patient characteristics is essential to achieve more equitable prescribing.
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Analgésicos Opioides , Alta do Paciente , Padrões de Prática Médica , Humanos , Analgésicos Opioides/uso terapêutico , Masculino , Feminino , Pessoa de Meia-Idade , Padrões de Prática Médica/estatística & dados numéricos , Fatores Sexuais , Idoso , Manejo da Dor/métodos , Adulto , Prescrições de Medicamentos/estatística & dados numéricos , HospitalizaçãoRESUMO
Objective: Recent clinical guidelines for sepsis management emphasize immediate antibiotic initiation for suspected septic shock. Though hypotension is a high-risk marker of sepsis severity, prior studies have not considered the precise timing of hypotension in relation to antibiotic initiation and how clinical characteristics and outcomes may differ. Our objective was to evaluate antibiotic initiation in relation to hypotension to characterize differences in sepsis presentation and outcomes in patients with suspected septic shock. Methods: Adults presenting to the emergency department (ED) June 2012-December 2018 diagnosed with sepsis (Sepsis-III electronic health record [EHR] criteria) and hypotension (non-resolving for ≥30 min, systolic blood pressure <90 mmHg) within 24 h. We categorized patients who received antibiotics before hypotension ("early"), 0-60 min after ("immediate"), and >60 min after ("late") treatment. Results: Among 2219 patients, 55% received early treatment, 13% immediate, and 32% late. The late subgroup often presented to the ED with hypotension (median 0 min) but received antibiotics a median of 191 min post-ED presentation. Clinical characteristics notable for this subgroup included higher prevalence of heart failure and liver disease (p < 0.05) and later onset of systemic inflammatory response syndrome (SIRS) criteria compared to early/immediate treatment subgroups (median 87 vs. 35 vs. 20 min, p < 0.0001). After adjustment, there was no difference in clinical outcomes among treatment subgroups. Conclusions: There was significant heterogeneity in presentation and timing of antibiotic initiation for suspected septic shock. Patients with later treatment commonly had hypotension on presentation, had more hypotension-associated comorbidities, and developed overt markers of infection (eg, SIRS) later. While these factors likely contribute to delays in clinician recognition of suspected septic shock, it may not impact sepsis outcomes.
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BACKGROUND: Patients with limited English proficiency (LEP) may have worse health outcomes and differences in processes of care. Language status may particularly affect situations that depend on communication, such as symptom management or end-of-life (EOL) care. OBJECTIVE: The objective of this study was to assess whether opioid prescribing and administration differs by English proficiency (EP) status among hospitalized patients receiving EOL care. METHODS: This single-center retrospective study identified all adult patients receiving "comfort care" on the general medicine service from January 2013 to September 2021. We assessed for differences in the quantity of opioids administered (measured by oral morphine equivalents [OME]) by patient LEP status using multivariable linear regression, controlling for other patient and medical factors. RESULTS: We identified 2652 patients receiving comfort care at our institution during the time period, of whom 1813 (68%) died during the hospitalization. There were no significant differences by LEP status in terms of mean OME per day (LEP received 30.8 fewer OME compared to EP, p = .91) or in the final 24 h before discharge (LEP received 61.7 more OME compared to EP, p = .80). CONCLUSION: LEP was not associated with differences in the amount of opioids received for patients whose EOL management involved standardized order sets for symptom management at our hospital.
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Analgésicos Opioides , Proficiência Limitada em Inglês , Assistência Terminal , Humanos , Analgésicos Opioides/uso terapêutico , Analgésicos Opioides/administração & dosagem , Estudos Retrospectivos , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Pacientes Internados , Hospitalização , Cuidados PaliativosRESUMO
BACKGROUND: Patients with atrial fibrillation have a high mortality rate that is only partially attributable to vascular outcomes. The competing risk of death may affect the expected anticoagulant benefit. We determined if competing risks materially affect the guideline-endorsed estimate of anticoagulant benefit. METHODS: We conducted a secondary analysis of 12 randomized controlled trials that randomized patients with atrial fibrillation to vitamin K antagonists (VKAs) or either placebo or antiplatelets. For each participant, we estimated the absolute risk reduction (ARR) of VKAs to prevent stroke or systemic embolism using 2 methods-first using a guideline-endorsed model (CHA2DS2-VASc) and then again using a competing risk model that uses the same inputs as CHA2DS2-VASc but accounts for the competing risk of death and allows for nonlinear growth in benefit. We compared the absolute and relative differences in estimated benefit and whether the differences varied by life expectancy. RESULTS: A total of 7933 participants (median age, 73 years, 36% women) had a median life expectancy of 8 years (interquartile range, 6-12), determined by comorbidity-adjusted life tables and 43% were randomized to VKAs. The CHA2DS2-VASc model estimated a larger ARR than the competing risk model (median ARR at 3 years, 6.9% [interquartile range, 4.7%-10.0%] versus 5.2% [interquartile range, 3.5%-7.4%]; P<0.001). ARR differences varied by life expectancies: for those with life expectancies in the highest decile, 3-year ARR difference (CHA2DS2-VASc model - competing risk model 3-year risk) was -1.3% (95% CI, -1.3% to -1.2%); for those with life expectancies in the lowest decile, 3-year ARR difference was 4.7% (95% CI, 4.5%-5.0%). CONCLUSIONS: VKA anticoagulants were exceptionally effective at reducing stroke risk. However, VKA benefits were misestimated with CHA2DS2-VASc, which does not account for the competing risk of death nor decelerating treatment benefit over time. Overestimation was most pronounced when life expectancy was low and when the benefit was estimated over a multiyear horizon.
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Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Feminino , Idoso , Masculino , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Ensaios Clínicos Controlados Aleatórios como Assunto , Anticoagulantes/efeitos adversos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Fibrinolíticos/uso terapêutico , Vitamina K , Medição de Risco , Fatores de RiscoRESUMO
Introduction: Opioid administration is extremely common in the inpatient setting, yet we do not know how the administration of opioids varies across different medical conditions and patient characteristics on internal medicine services. Our goal was to assess racial, ethnic, and language-based inequities in opioid prescribing practices for patients admitted to internal medicine services. Methods: We conducted a retrospective cohort study of all adult patients admitted to internal medicine services from 2013 to 2021 and identified subcohorts of patients treated for the six most frequent primary hospital conditions (pneumonia, sepsis, cellulitis, gastrointestinal bleed, pyelonephritis/urinary tract infection, and respiratory disease) and three select conditions typically associated with pain (abdominal pain, acute back pain, and pancreatitis). We conducted a negative binomial regression analysis to determine how average administered daily opioids, measured as morphine milligram equivalents (MMEs), were associated with race, ethnicity, and language, while adjusting for additional patient demographics, hospitalization characteristics, medical comorbidities, prior opioid therapy, and substance use disorders. Results: The study cohort included 61,831 patient hospitalizations. In adjusted models, we found that patients with limited English proficiency received significantly fewer opioids (66 MMEs, 95% CI: 52, 80) compared to English-speaking patients (101 MMEs, 95% CI: 91, 111). Asian (59 MMEs, 95% CI: 51, 66), Latinx (89 MMEs, 95% CI: 79, 100), and multi-race/ethnicity patients (81 MMEs, 95% CI: 65, 97) received significantly fewer opioids compared to white patients (103 MMEs, 95% CI: 94, 112). American Indian/Alaska Native (227 MMEs, 95% CI: 110, 344) patients received significantly more opioids. Significant inequities were also identified across race, ethnicity, and language groups when analyses were conducted within the subcohorts. Most notably, Asian and Latinx patients received significantly fewer MMEs and American Indian/Alaska Native patients received significantly more MMEs compared to white patients for the top six most frequent conditions. Most patients from minority groups also received fewer MMEs compared to white patients for three select pain conditions. Discussion. There are notable inequities in opioid prescribing based on patient race, ethnicity, and language status for those admitted to inpatient internal medicine services across all conditions and in the subcohorts of the six most frequent hospital conditions and three pain-associated conditions. This represents an institutional and societal opportunity for quality improvement initiatives to promote equitable pain management.
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Analgésicos Opioides , Pacientes Internados , Adulto , Humanos , Analgésicos Opioides/uso terapêutico , Estudos Retrospectivos , Prescrições de Medicamentos , Padrões de Prática Médica , Dor Abdominal , Dor Pós-Operatória/tratamento farmacológicoRESUMO
Importance: Extending the duration of oral anticoagulation for venous thromboembolism (VTE) beyond the initial 3 to 6 months of treatment is often recommended, but it is not clear whether clinical outcomes differ when using direct oral anticoagulants (DOACs) or warfarin. Objective: To compare rates of recurrent VTE, hospitalizations for hemorrhage, and all-cause death among adults prescribed DOACs or warfarin whose anticoagulant treatment was extended beyond 6 months after acute VTE. Design, Setting, and Participants: This cohort study was conducted in 2 integrated health care delivery systems in California with adults aged 18 years or older who received a diagnosis of incident VTE between 2010 and 2018 and completed at least 6 months of oral anticoagulant treatment with DOACs or warfarin. Patients were followed from the end of the initial 6-month treatment period until discontinuation of anticoagulation, occurrence of an outcome event, health plan disenrollment, or end of the study follow-up period (December 31, 2019). Data were obtained from the Kaiser Permanente Virtual Data Warehouse and electronic health records. Data analysis was conducted from March 2022 to January 2023. Exposure: Dispensed prescriptions of DOACs or warfarin after a 6-month initial treatment for VTE. Main Outcomes and Measures: The primary outcomes were rates per 100 person-years of recurrent VTE, hospitalizations for hemorrhage, and all-cause death. Comparison of DOAC and warfarin outcomes were performed using multivariable Cox proportional hazards regression. Results: A total of 18â¯495 patients (5477 [29.6%] aged ≥75 years; 8973 women [48.5%]) with VTE who were treated with at least 6 months of anticoagulation were identified, of whom 2134 (11.5%) were receiving DOAC therapy and 16â¯361 (88.5%) were receiving warfarin therapy. Unadjusted event rates were lower for patients receiving DOAC therapy than warfarin therapy for recurrent VTE (event rate per 100 person-years, 2.92 [95% CI, 2.29-3.54] vs 4.14 [95% CI, 3.90-4.38]), hospitalizations for hemorrhage (event rate per 100 person-years, 1.02 [95% CI, 0.66-1.39] vs 1.81 [95% CI, 1.66-1.97]), and all-cause death (event rate per 100 person-years, 3.79 [95% CI, 3.09-4.49] vs 5.40 [95% CI, 5.13-5.66]). After multivariable adjustment, DOAC treatment was associated with a lower risk of recurrent VTE (adjusted hazard ratio [aHR], 0.66; 95% CI, 0.52-0.82). For patients prescribed DOAC treatment, the risks of hospitalization for hemorrhage (aHR, 0.79; 95% CI, 0.54-1.17) and all-cause death (aHR, 0.96; 95% CI, 0.78-1.19) were not significantly different than those for patients prescribed warfarin treatment. Conclusions and Relevance: In this cohort study of patients with VTE who continued warfarin or DOAC anticoagulation beyond 6 months, DOAC treatment was associated with a lower risk of recurrent VTE, supporting the use of DOACs for the extended treatment of VTE in terms of clinical outcomes.
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Tromboembolia Venosa , Varfarina , Adulto , Humanos , Feminino , Varfarina/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/epidemiologia , Estudos de Coortes , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologiaRESUMO
AIM: Nurses assess patients' pain using several validated tools. It is not known what disparities exist in pain assessment for medicine inpatients. Our purpose was to measure differences in pain assessment across patient characteristics, including race, ethnicity, and language status. METHODS: Retrospective cohort study of adult general medicine inpatients from 2013 to 2021. The primary exposures were race/ethnicity and limited English proficiency (LEP) status. The primary outcomes were 1) the type and odds of which pain assessment tool nursing used and 2) the relationship between pain assessments and daily opioid administration. RESULTS: Of 51,602 patient hospitalizations, 46.1% were white, 17.4% Black, 16.5% Asian, and 13.2% Latino. 13.2% of patients had LEP. The most common pain assessment tool was the Numeric Rating Scale (68.1%), followed by the Verbal Descriptor Scale (23.7%). Asian patients and patients with LEP were less likely to have their pain documented numerically. In multivariable logistic regression, patients with LEP (OR 0.61, 95% CI 0.58-0.65) and Asian patients (OR 0.74, 95% CI 0.70-0.78) had the lowest odds of numeric ratings. Latino, Multi-Racial, and patients classified as Other also had lower odds than white patients of numeric ratings. Asian patients and patients with LEP received the fewest daily opioids across all pain assessment categories. CONCLUSIONS: Asian patients and patients with LEP were less likely than other patient groups to have a numeric pain assessment and received the fewest opioids. These inequities may serve as the basis for the development of equitable pain assessment protocols.
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Analgésicos Opioides , Etnicidade , Humanos , Adulto , Medição da Dor , Analgésicos Opioides/uso terapêutico , Estudos Retrospectivos , Idioma , Dor/tratamento farmacológicoRESUMO
Management of patients taking anticoagulants around the time of a procedure is a common and complex clinical scenario. Providing evidence-based care requires estimation of risk for thrombosis and bleeding, knowledge of commonly used medications, multidisciplinary communication and collaboration, and patient engagement and education. This review provides a standardized, evidence-based approach to periprocedural management of anticoagulation, based on current evidence and expert clinical guidelines.
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Anticoagulantes , Trombose , Humanos , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Trombose/prevenção & controle , Assistência Perioperatória , Administração OralRESUMO
BACKGROUND: Identifying COVID-19 patients at the highest risk of poor outcomes is critical in emergency department (ED) presentation. Sepsis risk stratification scores can be calculated quickly for COVID-19 patients but have not been evaluated in a large cohort. OBJECTIVE: To determine whether well-known risk scores can predict poor outcomes among hospitalized COVID-19 patients. DESIGNS, SETTINGS, AND PARTICIPANTS: A retrospective cohort study of adults presenting with COVID-19 to 156 Hospital Corporation of America (HCA) Healthcare EDs, March 2, 2020, to February 11, 2021. INTERVENTION: Quick Sequential Organ Failure Assessment (qSOFA), Shock Index, National Early Warning System-2 (NEWS2), and quick COVID-19 Severity Index (qCSI) at presentation. MAIN OUTCOME AND MEASURES: The primary outcome was in-hospital mortality. Secondary outcomes included intensive care unit (ICU) admission, mechanical ventilation, and vasopressors receipt. Patients scored positive with qSOFA ≥ 2, Shock Index > 0.7, NEWS2 ≥ 5, and qCSI ≥ 4. Test characteristics and area under the receiver operating characteristics curves (AUROCs) were calculated. RESULTS: We identified 90,376 patients with community-acquired COVID-19 (mean age 64.3 years, 46.8% female). 17.2% of patients died in-hospital, 28.6% went to the ICU, 13.7% received mechanical ventilation, and 13.6% received vasopressors. There were 3.8% qSOFA-positive, 45.1% Shock Index-positive, 49.8% NEWS2-positive, and 37.6% qCSI-positive at ED-triage. NEWS2 exhibited the highest AUROC for in-hospital mortality (0.593, confidence interval [CI]: 0.588-0.597), ICU admission (0.602, CI: 0.599-0.606), mechanical ventilation (0.614, CI: 0.610-0.619), and vasopressor receipt (0.600, CI: 0.595-0.604). CONCLUSIONS: Sepsis severity scores at presentation have low discriminative power to predict outcomes in COVID-19 patients and are not reliable for clinical use. Severity scores should be developed using features that accurately predict poor outcomes among COVID-19 patients to develop more effective risk-based triage.
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COVID-19 , Sepse , Adulto , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , COVID-19/diagnóstico , Estudos Retrospectivos , Sistemas Automatizados de Assistência Junto ao Leito , Escores de Disfunção Orgânica , Serviço Hospitalar de Emergência , Curva ROC , Prognóstico , Mortalidade Hospitalar , Unidades de Terapia IntensivaRESUMO
Importance: Patients hospitalized with COVID-19 have higher rates of venous thromboembolism (VTE), but the risk and predictors of VTE among individuals with less severe COVID-19 managed in outpatient settings are less well understood. Objectives: To assess the risk of VTE among outpatients with COVID-19 and identify independent predictors of VTE. Design, Setting, and Participants: A retrospective cohort study was conducted at 2 integrated health care delivery systems in Northern and Southern California. Data for this study were obtained from the Kaiser Permanente Virtual Data Warehouse and electronic health records. Participants included nonhospitalized adults aged 18 years or older with COVID-19 diagnosed between January 1, 2020, and January 31, 2021, with follow-up through February 28, 2021. Exposures: Patient demographic and clinical characteristics identified from integrated electronic health records. Main Outcomes and Measures: The primary outcome was the rate per 100 person-years of diagnosed VTE, which was identified using an algorithm based on encounter diagnosis codes and natural language processing. Multivariable regression using a Fine-Gray subdistribution hazard model was used to identify variables independently associated with VTE risk. Multiple imputation was used to address missing data. Results: A total of 398â¯530 outpatients with COVID-19 were identified. The mean (SD) age was 43.8 (15.8) years, 53.7% were women, and 54.3% were of self-reported Hispanic ethnicity. There were 292 (0.1%) VTE events identified over the follow-up period, for an overall rate of 0.26 (95% CI, 0.24-0.30) per 100 person-years. The sharpest increase in VTE risk was observed during the first 30 days after COVID-19 diagnosis (unadjusted rate, 0.58; 95% CI, 0.51-0.67 per 100 person-years vs 0.09; 95% CI, 0.08-0.11 per 100 person-years after 30 days). In multivariable models, the following variables were associated with a higher risk for VTE in the setting of nonhospitalized COVID-19: age 55 to 64 years (HR 1.85 [95% CI, 1.26-2.72]), 65 to 74 years (3.43 [95% CI, 2.18-5.39]), 75 to 84 years (5.46 [95% CI, 3.20-9.34]), greater than or equal to 85 years (6.51 [95% CI, 3.05-13.86]), male gender (1.49 [95% CI, 1.15-1.96]), prior VTE (7.49 [95% CI, 4.29-13.07]), thrombophilia (2.52 [95% CI, 1.04-6.14]), inflammatory bowel disease (2.43 [95% CI, 1.02-5.80]), body mass index 30.0-39.9 (1.57 [95% CI, 1.06-2.34]), and body mass index greater than or equal to 40.0 (3.07 [1.95-4.83]). Conclusions and Relevance: In this cohort study of outpatients with COVID-19, the absolute risk of VTE was low. Several patient-level factors were associated with higher VTE risk; these findings may help identify subsets of patients with COVID-19 who may benefit from more intensive surveillance or VTE preventive strategies.
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COVID-19 , Tromboembolia Venosa , Adulto , Humanos , Masculino , Feminino , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Estudos de Coortes , Estudos Retrospectivos , Teste para COVID-19 , COVID-19/complicações , COVID-19/epidemiologiaRESUMO
Background: Patients with atrial fibrillation (AF) have a high rate of all-cause mortality that is only partially attributable to vascular outcomes. While the competing risk of death may affect expected anticoagulant benefit, guidelines do not account for it. We sought to determine if using a competing risks framework materially affects the guideline-endorsed estimate of absolute risk reduction attributable to anticoagulants. Methods: We conducted a secondary analysis of 12 RCTs that randomized patients with AF to oral anticoagulants or either placebo or antiplatelets. For each participant, we estimated the absolute risk reduction (ARR) of anticoagulants to prevent stroke or systemic embolism using two methods. First, we estimated the ARR using a guideline-endorsed model (CHA 2 DS 2 -VASc) and then again using a Competing Risk Model that uses the same inputs as CHA 2 DS 2 -VASc but accounts for the competing risk of death and allows for non-linear growth in benefit over time. We compared the absolute and relative differences in estimated benefit and whether the differences in estimated benefit varied by life expectancy. Results: 7933 participants had a median life expectancy of 8 years (IQR 6, 12), determined by comorbidity-adjusted life tables. 43% were randomized to oral anticoagulation (median age 73 years, 36% women). The guideline-endorsed CHA 2 DS 2 -VASc model estimated a larger ARR than the Competing Risk Model (median ARR at 3 years, 6.9% vs. 5.2%). ARR differences varied by life expectancies: for those with life expectancies in the highest decile, 3-year ARR difference (CHA 2 DS 2 -VASc model - Competing Risk Model 3-year risk) was -1.2% (42% relative underestimation); for those with life expectancies in the lowest decile, 3-year ARR difference was 5.9% (91% relative overestimation). Conclusion: Anticoagulants were exceptionally effective at reduced stroke risk. However, anticoagulant benefits were misestimated with CHA 2 DS 2 -VASc, which does not account for the competing risk of death nor decelerating treatment benefit over time. Overestimation was most pronounced in patients with the lowest life expectancy and when benefit was estimated over a multi-year horizon.
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While social characteristics are well-known predictors of mortality, prediction models rely almost exclusively on demographics, medical comorbidities, and function. Lacking an efficient way to summarize the prognostic impact of social factor, many studies exclude social factors altogether. Our objective was to develop and validate a summary measure of social risk and determine its ability to risk-stratify beyond traditional risk models. We examined participants in the Health and Retirement Study, a longitudinal, survey of US older adults. We developed the model from a comprehensive inventory of 183 social characteristics using least absolute shrinkage and selection operator, a penalized regression approach. Then, we assessed the predictive capacity of the model and its ability to improve on traditional prediction models. We studied 8,250 adults aged ≥65 y. Within 4 y of the baseline interview, 22% had died. Drawn from 183 possible predictors, the Social Frailty Index included age, gender, and eight social predictors: neighborhood cleanliness, perceived control over financial situation, meeting with children less than yearly, not working for pay, active with children, volunteering, feeling isolated, and being treated with less courtesy or respect. In the validation cohort, predicted and observed mortality were strongly correlated. Additionally, the Social Frailty Index meaningfully risk-stratified participants beyond the Charlson score (medical comorbidity index) and the Lee Index (comorbidity and function model). The Social Frailty Index includes age, gender, and eight social characteristics and accurately risk-stratifies older adults. The model improves upon commonly used risk prediction tools and has application in clinical, population health, and research settings.
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Fragilidade , Criança , Humanos , Idoso , Estudos Longitudinais , Aposentadoria , Fatores SociológicosRESUMO
Atrial fibrillation (AF) is one of the strongest risk factors for ischemic stroke, which is a leading cause of disability and death. Given the aging population, increasing prevalence of AF risk factors, and improved survival in those with cardiovascular disease, the number of individuals affected by AF will continue increasing over time. While multiple proven stroke prevention therapies exist, important questions remain about the optimal approach to stroke prevention at the population and individual patient levels. Our report summarizes the National Heart, Lung, and Blood Institute virtual workshop focused on identifying key research opportunities related to stroke prevention in AF. The workshop reviewed major knowledge gaps and identified targeted research opportunities to advance stroke prevention in AF in the following areas: (1) improving risk stratification tools for stroke and intracranial hemorrhage; (2) addressing challenges with oral anticoagulants; and (3) delineating the optimal roles of percutaneous left atrial appendage occlusion and surgical left atrial appendage closure/excision. This report aims to promote innovative, impactful research that will lead to more personalized, effective use of stroke prevention strategies in people with AF.
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Fibrilação Atrial , Acidente Vascular Cerebral , Estados Unidos/epidemiologia , Humanos , Idoso , Fibrilação Atrial/complicações , National Heart, Lung, and Blood Institute (U.S.) , Coração , Academias e Institutos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controleRESUMO
BACKGROUND: Venous thromboembolism (VTE) treatment requires complex management, and patients with limited health literacy (HL) may perceive higher burden and lower benefits associated with their treatment. OBJECTIVE: To examine the association of HL with treatment satisfaction among patients with VTE. DESIGN: Retrospective cohort study PARTICIPANTS: Kaiser Permanente Southern and Northern California members who were taking oral anticoagulants (OAC) for incident VTE between 2015 and 2018 were surveyed. Main Measures HL was assessed using a 3-item HL assessment and dichotomized as having adequate or limited HL. High treatment burden and low treatment benefit were defined as Anti-Clot Treatment Scale (ACTS) scores below the 25th percentile of the distributions for ACTS Burdens and Benefits survey components, respectively. Using Poisson regression, multivariable adjusted risk ratios (RR) and 95% confidence intervals (CI) were calculated for the association of HL with high treatment burden and low treatment benefits. RESULTS: Among 2154 respondents, 397 (18.4%) had limited HL. Patients with limited vs adequate HL were older (47.9% vs 27.5% aged ≥ 75 years, p<0.001), more likely to use a non-English language when discussing their health (10.8% vs 1.7%, p<0.001), to have less than high school education (10.1% vs 1.7%, p<0.001), and to self-rate their health as fair or poor (47.6% vs 25.5%, p<0.001). After multivariable adjustment, patients with limited HL were more likely to have higher perceived treatment burden (RR 1.24, 95% CI 1.07, 1.45) and lower perceived treatment benefits (RR 1.21, 95% CI 1.08, 1.37). CONCLUSIONS: Limited HL was associated with lower OAC treatment satisfaction, though absolute differences in satisfaction scores were small. Further examination of the intersection of HL with VTE treatment satisfaction and compliance among older and non-English speaking patients is warranted.
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Letramento em Saúde , Tromboembolia Venosa , Humanos , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/epidemiologia , Estudos Retrospectivos , Satisfação do Paciente , AnticoagulantesRESUMO
The Anticoagulation Length of Therapy and Risk of New Adverse Events In Venous Thromboembolism (ALTERNATIVE) study was designed to compare the benefits and harms of different treatment options for extended treatment of venous thromboembolism (VTE). In this paper, we describe the study cohort, survey data collection, and preliminary results. We identified 39,605 adult patients (age ≥ 18 years) from two large integrated health care delivery systems who were diagnosed with incident VTE and received initial anticoagulation therapy of 3 months or longer. A subset of the cohort (12,737) was invited to participate in a survey. Surveys were completed in English, Spanish or Mandarin via a mailed questionnaire, an online secure web link, or telephone. The survey domains included demographics, personal medical history, anticoagulant treatment history, anticoagulant treatment satisfaction, health-related quality of life and health literacy. A total of 5,017 patients participated in the survey for an overall response rate of 39.4%. The mean (SD) age of the survey respondents was 63.0 (14.5) years and self-reported race was 76.0% White/European, 11.1% Black/African American, and 3.8% Asian/Pacific Islander and 14.0% reported Hispanic ethnicity. Sixty percent of respondents completed the web survey, while 29.0% completed the mail-in paper survey, and 11.0% completed the survey via telephone. The ALTERNATIVE Study will address knowledge gaps by comparing several treatment alternatives for the extended management of VTE so that this information could be used by patients and clinicians to make more informed, patient-centered treatment choices.
Assuntos
Letramento em Saúde , Tromboembolia Venosa , Humanos , Adolescente , Pessoa de Meia-Idade , Tromboembolia Venosa/tratamento farmacológico , Qualidade de VidaRESUMO
Importance: Oral anticoagulation (OAC) is underprescribed in underrepresented racial and ethnic group individuals with atrial fibrillation (AF). Little is known of how differential OAC prescribing relates to inequities in AF outcomes. Objective: To compare OAC use at discharge and AF-related outcomes by race and ethnicity in the Get With The Guidelines-Atrial Fibrillation (GWTG-AFIB) registry. Design, Setting, and Participants: This retrospective cohort analysis used data from the GWTG-AFIB registry, a national quality improvement initiative for hospitalized patients with AF. All registry patients hospitalized with AF from 2014 to 2020 were included in the study. Data were analyzed from November 2021 to July 2022. Exposures: Self-reported race and ethnicity assessed in GWTG-AFIB registry. Main Outcomes and Measures: The primary outcome was prescription of direct-acting OAC (DOAC) or warfarin at discharge. Secondary outcomes included cumulative 1-year incidence of ischemic stroke, major bleeding, and mortality postdischarge. Outcomes adjusted for patient demographic, clinical, and socioeconomic characteristics as well as hospital factors. Results: Among 69â¯553 patients hospitalized with AF from 159 sites between 2014 and 2020, 863 (1.2%) were Asian, 5062 (7.3%) were Black, 4058 (5.8%) were Hispanic, and 59â¯570 (85.6%) were White. Overall, 34â¯113 (49.1%) were women; the median (IQR) age was 72 (63-80) years, and the median (IQR) CHA2DS2-VASc score (calculated as congestive heart failure, hypertension, age 75 years and older, diabetes, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, and sex category) was 4 (2-5). At discharge, 56â¯385 patients (81.1%) were prescribed OAC therapy, including 41â¯760 (74.1%) receiving DOAC. OAC prescription at discharge was lowest in Hispanic patients (3010 [74.2%]), followed by Black patients (3935 [77.7%]) Asian patients (691 [80.1%]), and White patients (48â¯749 [81.8%]). Black patients were less likely than White patients to be discharged while taking any anticoagulant (adjusted odds ratio, 0.75; 95% CI, 0.68-0.84) and DOACs (adjusted odds ratio, 0.73; 95% CI, 0.65-0.82). In 16â¯307 individuals with 1-year follow up data, bleeding risks (adjusted hazard ratio [aHR], 2.08; 95% CI, 1.53-2.83), stroke risks (aHR, 2.07; 95% CI, 1.34-3.20), and mortality risks (aHR, 1.22; 95% CI, 1.02-1.47) were higher in Black patients than White patients. Hispanic patients had higher stroke risk (aHR, 2.02; 95% CI, 1.38-2.95) than White patients. Conclusions and Relevance: In a national registry of hospitalized patients with AF, compared with White patients, Black patients were less likely to be discharged while taking anticoagulant therapy and DOACs in particular. Black and Hispanic patients had higher risk of stroke compared with White patients; Black patients had a higher risk of bleeding and mortality. There is an urgent need for interventions to achieve pharmacoequity in guideline-directed AF management to improve overall outcomes.
Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Etnicidade , Estudos Retrospectivos , Assistência ao Convalescente , Alta do Paciente , Anticoagulantes/uso terapêutico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Sistema de Registros , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/complicaçõesRESUMO
INTRODUCTION: Venous thromboembolism (VTE) is commonly treated with oral anticoagulants, including warfarin or direct oral anticoagulants (DOACs). Although DOACs are associated with favorable treatment satisfaction, few studies have assessed whether quality of life differs between DOAC and warfarin users. MATERIALS AND METHODS: We invited adults enrolled in two California-based integrated health care delivery systems and with a history of VTE between January 1, 2015 and June 30, 2018 to complete a survey on their experience with anticoagulants. Health-related quality of life (QOL) was assessed using the RAND 36-item Short Form Health Survey (SF-36), which measures QOL in 2 general component scores (physical and mental). We used multivariable linear regression to compare mean QOL component scores between DOAC-users and warfarin-users, adjusting for patient and clinical characteristics. RESULTS: Overall, 2230 patients (43.1 % women and 31.8 % >75 years of age) taking anticoagulants answered at least 1 question on the SF-36, 975 taking DOACs and 1255 taking warfarin. After adjustment for patient-level factors, there were no significant differences in either physical component scores (39.2 v 38.3, p = 0.24) or mental component scores (48.5 v 49.0, p = 0.42) between DOAC and warfarin users. CONCLUSIONS: Health-related QOL did not significantly differ between DOAC and warfarin users with a history of VTE.