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.

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.

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.

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.