Prospective Observational Cohort Study of Tenecteplase Versus Alteplase in Routine Clinical Practice.

BACKGROUND: A 10-hospital regional network transitioned to tenecteplase as the standard of care stroke thrombolytic in September 2019 because of potential workflow advantages and reported noninferior clinical outcomes relative to alteplase in meta-analyses of randomized trials. We assessed whether tenecteplase use in routine clinical practice reduced thrombolytic workflow times with noninferior clinical outcomes. METHODS: We designed a prospective registry-based observational, sequential cohort comparison of tenecteplase- (n=234) to alteplase-treated (n=354) stroke patients. We hypothesized: (1) an increase in the proportion of patients meeting target times for target door-to-needle time and transfer door-in-door-out time, and (2) noninferior favorable (discharge to home with independent ambulation) and unfavorable (symptomatic intracranial hemorrhage, in-hospital mortality or discharge to hospice) in the tenecteplase group. Total hospital cost associated with each treatment was also compared. RESULTS: Target door-to-needle time within 45 minutes for all patients was superior for tenecteplase, 41% versus 29%; adjusted odds ratio, 1.85 (95% CI, 1.27-2.71); P=0.001; 58% versus 41% by Get With The Guidelines criteria. Target door-in-door-out time within 90 minutes was superior for tenecteplase 37% (15/43) versus 14% (9/65); adjusted odds ratio, 3.62 (95% CI, 1.30-10.74); P=0.02. Favorable outcome for tenecteplase fell within the 6.5% noninferiority margin; adjusted odds ratio, 1.26 (95% CI, 0.89-1.80). Unfavorable outcome was less for tenecteplase, 7.3% versus 11.9%, adjusted odds ratio, 0.77 (95% CI, 0.42-1.37) but did not fall within the prespecified 1% noninferior boundary. Net benefit (%favorable-%unfavorable) was greater for the tenecteplase sample: 37% versus 27%. P=0.02. Median cost per hospital encounter was less for tenecteplase cases ($13 382 versus $15 841; P<0.001). CONCLUSIONS: Switching to tenecteplase in routine clinical practice in a 10-hospital network was associated with shorter door-to-needle time and door-in-door-out times, noninferior favorable clinical outcomes at discharge, and reduced hospital costs. Evaluation in larger, multicenter cohorts is recommended to determine if these observations generalize.

COVID-19 hospital prevalence as a risk factor for mortality: an observational study of a multistate cohort of 62 hospitals.

BACKGROUND: The associated mortality with COVID-19 has improved compared with the early pandemic period. The effect of hospital COVID-19 patient prevalence on COVID-19 mortality has not been well studied. METHODS: We analysed data for adults with confirmed SARS-CoV-2 infection admitted to 62 hospitals within a multistate health system over 12 months. Mortality was evaluated based on patient demographic and clinical risk factors, COVID-19 hospital prevalence and calendar time period of the admission, using a generalised linear mixed model with site of care as the random effect. RESULTS: 38 104 patients with COVID-19 were hospitalised, and during their encounters, the prevalence of COVID-19 averaged 16% of the total hospitalised population. Between March-April 2020 and January-February 2021, COVID-19 mortality declined from 19% to 12% (p<0.001). In the adjusted multivariable analysis, mid and high COVID-19 inpatient prevalence were associated with a 25% and 41% increase in the odds (absolute contribution to probability of death of 2%-3%) of COVID-19 mortality compared with patients with COVID-19 in facilities with low prevalence (<10%), respectively (high prevalence >25%: adjusted OR (AOR) 1.41, 95% CI 1.23 to 1.61; mid-prevalence (10%-25%): AOR 1.25, 95% CI 1.13 to 1.38). Mid and high COVID-19 prevalence accounted for 76% of patient encounters. CONCLUSIONS: Although inpatient mortality for patients with COVID-19 has sharply declined compared with earlier in the pandemic, higher COVID-19 hospital prevalence remained a common risk factor for COVID-19 mortality. Hospital leaders need to reconsider how we provide support to care for patients in times of increased volume and complexity, such as those experienced during COVID-19 surges.

Association of Race With Mortality Among Patients Hospitalized With Coronavirus Disease 2019 (COVID-19) at 92 US Hospitals.

IMPORTANCE: While current reports suggest that a disproportionate share of US coronavirus disease 2019 (COVID-19) cases and deaths are among Black residents, little information is available regarding how race is associated with in-hospital mortality. OBJECTIVE: To evaluate the association of race, adjusting for sociodemographic and clinical factors, on all-cause, in-hospital mortality for patients with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: This cohort study included 11 210 adult patients (age ≥18 years) hospitalized with confirmed severe acute respiratory coronavirus 2 (SARS-CoV-2) between February 19, 2020, and May 31, 2020, in 92 hospitals in 12 states: Alabama (6 hospitals), Maryland (1 hospital), Florida (5 hospitals), Illinois (8 hospitals), Indiana (14 hospitals), Kansas (4 hospitals), Michigan (13 hospitals), New York (2 hospitals), Oklahoma (6 hospitals), Tennessee (4 hospitals), Texas (11 hospitals), and Wisconsin (18 hospitals). EXPOSURES: Confirmed SARS-CoV-2 infection by positive result on polymerase chain reaction testing of a nasopharyngeal sample. MAIN OUTCOMES AND MEASURES: Death during hospitalization was examined overall and by race. Race was self-reported and categorized as Black, White, and other or missing. Cox proportional hazards regression with mixed effects was used to evaluate associations between all-cause in-hospital mortality and patient characteristics while accounting for the random effects of hospital on the outcome. RESULTS: Of 11 210 patients with confirmed COVID-19 presenting to hospitals, 4180 (37.3%) were Black patients and 5583 (49.8%) were men. The median (interquartile range) age was 61 (46 to 74) years. Compared with White patients, Black patients were younger (median [interquartile range] age, 66 [50 to 80] years vs 61 [46 to 72] years), were more likely to be women (2259 [49.0%] vs 2293 [54.9%]), were more likely to have Medicaid insurance (611 [13.3%] vs 1031 [24.7%]), and had higher median (interquartile range) scores on the Neighborhood Deprivation Index (-0.11 [-0.70 to 0.56] vs 0.82 [0.08 to 1.76]) and the Elixhauser Comorbidity Index (21 [0 to 44] vs 22 [0 to 46]). All-cause in-hospital mortality among hospitalized White and Black patients was 23.1% (724 of 3218) and 19.2% (540 of 2812), respectively. After adjustment for age, sex, insurance, comorbidities, neighborhood deprivation, and site of care, there was no statistically significant difference in risk of mortality between Black and White patients (hazard ratio, 0.93; 95% CI, 0.80 to 1.09). CONCLUSIONS AND RELEVANCE: Although current reports suggest that Black patients represent a disproportionate share of COVID-19 infections and death in the United States, in this study, mortality for those able to access hospital care did not differ between Black and White patients after adjusting for sociodemographic factors and comorbidities.

Fundamental Epidemiology Terminology and Measures: It Really Is All in the Name.

Epidemiology is the study of how disease is distributed in populations and the factors that influence or determine this distribution. Clinical epidemiology denotes the application of epidemiologic methods to questions relevant to patient care and provides a highly useful set of principles and methods for the design and conduct of quantitative clinical research. Validly analyzing, correctly reporting, and successfully interpreting the findings of a clinical research study often require an understanding of the epidemiologic terms and measures that describe the patterns of association between the exposure of interest (treatment or intervention) and a health outcome (disease). This statistical tutorial thus discusses selected fundamental epidemiologic concepts and terminology that are applicable to clinical research. Incidence is the occurrence of a health outcome during a specific time period. Prevalence is the existence of a health outcome during a specific time period. The relative risk can be defined as the probability of the outcome of interest (eg, developing the disease) among exposed individuals compared to the probability of the same event in nonexposed individuals. The odds ratio is a measure of risk that compares the frequency of exposure to a putative causal factor in the individuals with the health outcome (cases) versus those individuals without the health outcome (controls). Factors that are associated with both the exposure and the outcome of interest need to be considered to avoid bias in your estimate of risk. Because it takes into consideration the contribution of extraneous variables (confounders), the adjusted odds ratio provides a more valid estimation of the association between the exposure and the health outcome and thus is the preferably reported measure. The odds ratio closely approximates the risk ratio in a cohort study or a randomized controlled trial when the outcome of interest does not occur frequently (<10%). The editors, reviewers, authors, and readers of journal articles should be aware of and make the key distinction between the absolute risk reduction and the relative risk reduction. In assessing the findings of a clinical study, the investigators, reviewers, and readers must determine if the findings are not only statistically significant, but also clinically meaningful. Furthermore, in deciding on the merits of a new medication or other therapeutic intervention, the clinician must balance the benefits versus the adverse effects in individual patients. The number needed to treat and the number needed to harm can provide this needed additional insight and perspective.

A retrospective review of swallow dysfunction in patients with severe traumatic brain injury.

In the acute-care setting, it is difficult for clinicians to determine which patients with severe traumatic brain injury will have long-term oropharyngeal dysphagia (>6 weeks) and which patients will begin oral nutrition quickly. Patients frequently remain in the acute-care setting while physicians determine whether to place a percutaneous endoscopic gastrostomy (PEG) tube. To improve the acute-care clinician's ability to predict long-term oropharyngeal dysphagia and subsequent need for PEG tube placement in patients with severe traumatic brain injury [Glascow Coma Scale (GCS) ≤ 8), a novel prediction model was created utilizing clinical information and acute-care swallowing evaluation findings. Five years of retrospective data were obtained from trauma patients at a Level 1 trauma hospital. Of the 375 patients who survived their hospitalization with a GCS ≤ 8, a total of 269 patients received Ranchos Los Amigos (RLA) scores. Of those patients who were scored for RLA, 219 patients underwent swallowing evaluation. Ninety-six of the 219 patients were discharged from the hospital with a feeding tube, and 123 patients were discharged without one. Logistic regression models examined the association between clinical and patient characteristics and whether a patient with severe traumatic brain injury exhibited long-term oropharyngeal dysphagia. Multivariable logistic regression analysis revealed that increased age, low RLA score, tracheostomy tube placement, and aphonia observed on the initial swallowing evaluation significantly increased the odds of being discharged from the acute-care hospital with a feeding tube. The resultant model could be used clinically to guide decision making and to counsel patients and families.

Patients labeled with delusions of parasitosis compose a heterogenous group: a retrospective study from a referral center.

BACKGROUND: There are few diagnostic tools available to the dermatologist to help in the diagnosis of patients with delusions of parasitosis (DOP). OBJECTIVE: We sought to find differences in presentation and clinical course between patients who received a final diagnosis of DOP and those who received a final diagnosis of a primary medical condition or other psychiatric disorder. METHODS: We performed a retrospective chart review of patients referred with a diagnosis of DOP. Each patient received a final consensus diagnosis. RESULTS: In all, 47 patients were included in the study. Patients reporting bugs were more likely to be given a final diagnosis of delusional disorder or found to have a medical diagnosis, whereas patients noting fibers were more likely to have a somatoform disorder. A review of systems can be helpful in making a final diagnosis. Patients referred to the clinic for DOP were 300 times more likely to require a physician to contact the hospital's legal counsel compared with other patients in the practice. LIMITATIONS: The retrospective nature of the study resulted in limited laboratory testing and psychiatric evaluation in some patients. Many of the patients may have been inappropriately referred to the DOP clinic because of other psychiatric comorbidities. CONCLUSION: Patients referred to this practice as "delusional" had a heterogeneous final diagnosis. The chief symptom of the patient was predictive of the patient's final diagnosis. The use of written questionnaires may be helpful. These patients have a greatly increased risk of requiring the physician to seek legal counsel.

Hospitalizations Due to Respiratory Syncytial Virus Outside of the Typical Season.

Objective: Respiratory Syncytial Virus (RSV) is the most common cause of bronchiolitis and viral lower respiratory tract infections in children. It is associated with annual winter epidemics across the United States, typically October through April. Our objective is to describe the clinical characteristics of children hospitalized outside the typical RSV season and to compare them with those admitted during the season. Methods: A retrospective chart review was conducted of all patients who were hospitalized at Children's Hospital of Austin from May 2000 to September 2006 and had a positive RSV antigen test. Descriptive statistics, tests of differences, and associations between patients diagnosed in the off-season versus typical season were conducted. Results: A total of 850 charts of RSV-positive cases were reviewed. Of these, 45 patients (5.3%) were admitted during the off-season. The following variables were statistically significantly associated with diagnosis in the off-season versus typical season: mean birth weight (2704 g vs. 3204 g respectively, p=0.0001); gestational age at birth less than 36 weeks (OR=4.35; 95% CI: 2.2, 8.6); history of neonatal intensive care unit (NICU) admission at birth (OR=6.04; 95% CI: 2.9, 12.5); and multiple birth (OR=3.38; 95% CI: 1.2, 9.2). Conclusions: Infants with RSV infection outside of the typical season were more likely to have been premature, of lower birth weight, the products of multiple births, and admitted to the NICU at birth.

Prevalence and predictors of smoking behavior among Vietnamese men living in California.

Vietnamese populations in Vietnam and the United States have a high prevalence of smoking. The associations among behavioral risk factors, acculturation, and smoking among the Vietnamese population living in the United States are not well documented. The present study aimed to identify the factors associated with smoking behavior among Vietnamese men living in Santa Clara County, California. A cross-sectional random-digit-dialed telephone survey was conducted. The sampling frame consisted of 27 Vietnamese surnames from the Santa Clara County telephone directory. A total of 660 adult respondents were interviewed to collect information on general health status, alcohol and tobacco use, HIV/AIDS, sexual behavior, injury control, hypertension, cholesterol screening, and acculturation. Of the 660 adults interviewed, 364 (55.2%) were male and 296 (44.8%) were female. Among males, 31.9% were current smokers, and among females, only one woman reported smoking. Univariate analyses revealed that having less than a college education, having poor English language skills, using Vietnamese at home and with friends, being less acculturated, not having a routine physical or blood cholesterol check, and being a binge drinker were significantly associated with an increased likelihood of smoking. Multivariate analysis revealed two independently associated factors: Respondents who were more acculturated were less likely to smoke (OR = 0.38, 95% CI = 0.18-0.83), and those not having cholesterol checked were more likely to smoke (OR = 2.48, 95% CI = 1.30-4.71). Acculturation level was inversely associated with smoking among Vietnamese adult men in Santa Clara County. Other health risk behaviors coexisted with smoking behavior and should be considered in prevention programs.

Occupational injury surveillance among electric utility employees.

Currently, there are only limited injury surveillance data for the electric utility workforce. To address this gap, an Occupational Health Surveillance Database for electric power utilities was established for epidemiologic monitoring and intervention program evaluation. Injury rates varied across utility occupations, such as, managers, line workers, and meter readers, ranging from 0.18 to 9.63 per 100 employee-years based on more than 500,000 employee-years of observation. Compared with male workers, the risk of injury among female workers was lower overall, although their risk was higher in nonoffice occupations than their male counterparts. Across the period 2000 to 2002, three of four companies that experienced decreases in workforce size also experienced noticeable increases in injury rates. Our results suggest that benchmarking and prevention efforts should be directed at specific occupational groups and specific injury types.

Survival among U.S. women with invasive epithelial ovarian cancer.

OBJECTIVE: Invasive epithelial ovarian cancer is a highly fatal disease, diagnosed at advanced stages when survival is poor. Relatively little is known about the variation in survival across U.S. women of different race/ethnicities. To investigate this issue, we evaluated pathological characteristics and death rates due to invasive epithelial ovarian cancer in a population-based sample of patients from six racial/ethnic groups. METHODS: The analysis included 38,012 women diagnosed with primary invasive epithelial ovarian cancer between 1973 and 1997 in the Surveillance, Epidemiology and End Results Program of the National Cancer Institute. RESULTS: Filipina patients were younger at diagnosis, more likely to have localized disease, and had more mucinous cancers than whites. African-Americans were more likely than whites to be diagnosed at older ages, with distant disease and with undifferentiated/unclassified cancers. After adjusting for age at diagnosis, stage of disease at diagnosis, and cancer histology, we found that, compared to whites, death rates were significantly elevated among African-Americans and significantly reduced among Hispanics and Filipina. We also found that death rates declined significantly with time since diagnosis among women with advanced disease. CONCLUSION: The declining death rates in women with advanced disease suggest the presence of considerable prognostic heterogeneity among these women, which could reflect differences in quality of care. This issue, as well as the survival disadvantage for African-American women and survival advantages for Hispanic and Filipina women, needs investigation.