Postpartum Invasive Group A Streptococcal Disease in the Modern Era

To describe the clinical features of individuals hospitalized for postpartum invasive group A Streptococcus (GAS) infection, a retrospective, population-based study of hospitalized patients in the state of Florida was conducted. Cases of postpartum invasive GAS infection (occurring within 42 days of delivery) were compared to women with other manifestations of invasive GAS disease with respect to their age at the time of admission. Four cases of postpartum invasive GAS infection were detected in this population, yielding a prevalence of 1.6% (4/257) of postpartum disease in this invasive GAS infection database. Patients presented a median of 4 days (mean of 9 days) after delivery with signs and symptoms of infection. Three cases were complicated by bacteremia and one patient had streptococcal toxic shock syndrome. Each patient received multiple antibiotics and survived. No patients received intravenous immunoglobulin. For comparison, a secondary retrospective investigation of a large hospital discharge dataset obtained from the Florida Agency for Health Care Administration was assessed for patients with puerperal GAS infections. This method yielded an additional three cases, whose clinical and demographic characteristics were summarized. These data highlight that postpartum invasive GAS infection continues to complicate pregnancy, though the frequency has decreased markedly over the past century

Diabetes and kidney cancer: A direct or indirect association?

A positive association between diabetes and kidney cancer has been reported in several investigations, but it is unclear whether diabetes or its complications account for this association. Recent advances in estimating direct associations may be useful for elucidating the association between diabetes and kidney cancer. Therefore, we performed a case-control analysis to evaluate whether the direct association between diabetes and kidney cancer is the primary concern in this exposure-outcome relation. Discharge data (with International Classification of Diseases – 9 codes) from 2001 for hospitals throughout Florida were used to construct a case-control population of inpatients aged ≥45 years. Cases (n=1,909) were inpatients with malignant kidney cancer and controls (n=6,451) were inpatients with motor vehicle injuries. Diabetes status was ascertained for cases and controls. Covariates that required adjustment to estimate the total (age, gender, ethnicity, obesity, and smoking) and direct (age, gender, ethnicity, obesity, smoking, hypertension, and kidney disease) associations were identified in a directed acyclic graph. Binary logistic regression was used to estimate the adjusted total and direct odds ratios (ORs) and corresponding 95% confidence intervals (CIs) of kidney cancer for diabetics. The odds of kidney cancer were higher for inpatients with diabetes than inpatients without diabetes when estimating the total association (OR=1.27, 95%CI: 1.10, 1.47) but attenuated when estimating the direct association (OR=1.08, 95%CI: 0.93, 1.25). Our findings provide preliminary insight that the direct association between diabetes and kidney cancer may not be the primary concern in this exposure-outcome relation; indirect pathways (i.e. diabetic complications) may have greater influence on this relation. A similar analysis using longitudinal data with appropriately measured covariates may provide more definitive conclusions and could have implications for kidney cancer prevention among diabetics

Statistical Methods Useful in Clinical Simulation and Medical Education Scholarship

The objective of this paper is to introduce selected statistical and epidemiologic topics that are of interest to interdisciplinary teams of healthcare quality professionals, educators, technical staff, and researchers who participate in clinical simulation scholarship. Four research vignettes in the setting of a hypothetical clinical simulation training workshop are presented. The first vignette illustrates the utility of exact logistic regression when analyzing a small dataset. The second underscores the importance of using an appropriate method to account for the repeated measurement of an outcome. The third illustrates the use of the intraclass correlation coefficient to measure inter-rater reliability. The final vignette demonstrates the benefits of creating a causal diagram known as a directed acyclic graph

Impact of a Faculty Development Course on Promotion at a Health Sciences Center

Background: The objective of this study was to quantify the association between graduation from our annual comprehensive Institutional Faculty Development Course (IFDC) and being promoted from assistant professor to associate professor at our health sciences center. Methods: A retrospective cohort study (October 2008-October 2019) was conducted using publicly-available faculty data. A total of 148 IFDC graduates were compared to 87 non-graduates. Subjects were full-time assistant professors at Texas Tech University Health Sciences Center El Paso at the start of follow-up. The binary outcome was promotion to associate professor. The outcome was measured annually from 2008 to 2019. Follow-up ended when the faculty member left our institution, was promoted to associate professor, or the study ended, whichever came first. A longitudinal data analysis was performed using generalized estimating equations (GEE) logistic regression with an independent working correlation structure. Adjusted odds ratios (OR) for promotion were calculated from the GEE logistic regression model. Results: The 235 faculty members contributed a total of 1015 records. The average ages (standard deviation) of IFDC graduates and non-graduates were 40.7 (8.6) and 40.3 (7.4) years, respectively. More than half of the IFDC graduates were female (54.1%) and 44.8% of the non-graduates were female. A positive association was detected between IFDC status (graduates vs. non-graduates) and being promoted to associate professor after controlling for time, age, sex, race and Hispanic ethnicity, discipline/specialty, and tenure track status in a GEE logistic regression model: adjusted OR=11.68, 95% confidence interval: 2.72 – 50.21, P=0.001. Conclusions: Completion of the IFDC was strongly correlated with promotion to associate professor at our health sciences center

Elevated antiphospholipid antibody titers and adverse pregnancy outcomes: analysis of a population-based hospital dataset

<p>Abstract</p> <p>Background</p> <p>The primary objective of this study was to determine if elevated antiphospholipid antibody titers were correlated with the presence of preeclampsia/eclampsia, systemic lupus erythematosus (SLE), placental insufficiency, and a prolonged length of stay (PLOS), in women who delivered throughout Florida, USA.</p> <p>Methods</p> <p>Cross-sectional analyses were conducted using a statewide hospital database. Prevalence odds ratios (OR) were calculated to quantify the association between elevated antiphospholipid antibody titers and four outcomes in 141,286 women who delivered in Florida in 2001. The possibility that the relationship between elevated antiphospholipid antibody titers and the outcomes of preeclampsia/eclampsia, placental insufficiency, and PLOS, may have been modified by the presence of SLE was evaluated in a multiple logistic regression model by creating a composite interaction term.</p> <p>Results</p> <p>Women with elevated antiphospholipid antibody titers (n = 88) were older, more likely to be of white race and not on Medicaid than women who did not have elevated antiphospholipid antibody titers. Women who had elevated antiphospholipid antibody titers had an increased adjusted odds ratio for preeclampsia and eclampsia, (OR = 2.93 p = 0.0015), SLE (OR = 61.24 p < 0.0001), placental insufficiency (OR = 4.58 p = 0.0003), and PLOS (OR = 3.93 p < 0.0001). Patients who had both an elevated antiphospholipid antibody titer and SLE were significantly more likely than the comparison group (women without an elevated titer who did not have SLE) to have the outcomes of preeclampsia, placental insufficiency and PLOS.</p> <p>Conclusion</p> <p>This exploratory epidemiologic investigation found moderate to very strong associations between elevated antiphospholipid antibody titers and four important outcomes in a large sample of women.</p

Perspectives on Anaphylaxis Epidemiology in the United States with New Data and Analyses

Anaphylaxis incidence rates and time trends in the United States have been reported using different data sources and selection methods. Larger studies using diagnostic coding have inherent limitations in sensitivity and specificity. In contrast, smaller studies using chart reviews, including reports from single institutions, have better case characterization but suffer from reduced external validity due to their restricted nature. Increasing anaphylaxis hospitalization rates since the 1990s have been reported abroad. However, we report no significant overall increase in the United States. There have been several reports of increasing anaphylaxis rates in northern populations in the United States, especially in younger people, lending support to the suggestion that higher anaphylaxis rates occur at higher latitudes. We analyzed anaphylaxis hospitalization rates in comparably sized northern (New York) and southern (Florida) states and found significant time trend differences based on age. This suggests that the relationship of latitude to anaphylaxis incidence is complex

Outcomes of patients hospitalized for acute decompensated heart failure: does nesiritide make a difference?

<p>Abstract</p> <p>Background</p> <p>Nesiritide is indicated in the treatment of acute decompensated heart failure. However, a recent meta-analysis reported that nesiritide may be associated with an increased risk of death. Our goal was to evaluate the impact of nesiritide treatment on four outcomes among adults hospitalized for congestive heart failure (CHF) during a three-year period.</p> <p>Methods</p> <p>CHF patients discharged between 1/1/2002 and 12/31/2004 from the Adventist Health System, a national, not-for-profit hospital system, were identified. 25,330 records were included in this retrospective study. Nesiritide odds ratios (OR) were adjusted for various factors including nine medications and/or an APR-DRG severity score.</p> <p>Results</p> <p>Initially, treatment with nesiritide was found to be associated with a 59% higher odds of hospital mortality (Unadjusted OR = 1.59, 95% confidence interval [CI]: 1.31–1.93). Adjusting for race, low economic status, APR-DRG severity of illness score, and the receipt of nine medications yielded a nonsignificant nesiritide OR of 1.07 for hospital death (95% CI: 0.85–1.35). Nesiritide was positively associated with the odds of prolonged length of stay (all adjusted ORs = 1.66) and elevated pharmacy cost (all adjusted ORs > 5).</p> <p>Conclusion</p> <p>In this observational study, nesiritide therapy was associated with increased length of stay and pharmacy cost, but not hospital mortality. Randomized trials are urgently needed to better define the efficacy, if any, of nesiritide in the treatment of decompensated heart failure.</p

Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation.

OBJECTIVES: To provide an accurate, web-based tool for stratifying patients with atrial fibrillation to facilitate decisions on the potential benefits/risks of anticoagulation, based on mortality, stroke and bleeding risks. DESIGN: The new tool was developed, using stepwise regression, for all and then applied to lower risk patients. C-statistics were compared with CHA2DS2-VASc using 30-fold cross-validation to control for overfitting. External validation was undertaken in an independent dataset, Outcome Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). PARTICIPANTS: Data from 39 898 patients enrolled in the prospective GARFIELD-AF registry provided the basis for deriving and validating an integrated risk tool to predict stroke risk, mortality and bleeding risk. RESULTS: The discriminatory value of the GARFIELD-AF risk model was superior to CHA2DS2-VASc for patients with or without anticoagulation. C-statistics (95% CI) for all-cause mortality, ischaemic stroke/systemic embolism and haemorrhagic stroke/major bleeding (treated patients) were: 0.77 (0.76 to 0.78), 0.69 (0.67 to 0.71) and 0.66 (0.62 to 0.69), respectively, for the GARFIELD-AF risk models, and 0.66 (0.64-0.67), 0.64 (0.61-0.66) and 0.64 (0.61-0.68), respectively, for CHA2DS2-VASc (or HAS-BLED for bleeding). In very low to low risk patients (CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)), the CHA2DS2-VASc and HAS-BLED (for bleeding) scores offered weak discriminatory value for mortality, stroke/systemic embolism and major bleeding. C-statistics for the GARFIELD-AF risk tool were 0.69 (0.64 to 0.75), 0.65 (0.56 to 0.73) and 0.60 (0.47 to 0.73) for each end point, respectively, versus 0.50 (0.45 to 0.55), 0.59 (0.50 to 0.67) and 0.55 (0.53 to 0.56) for CHA2DS2-VASc (or HAS-BLED for bleeding). Upon validation in the ORBIT-AF population, C-statistics showed that the GARFIELD-AF risk tool was effective for predicting 1-year all-cause mortality using the full and simplified model for all-cause mortality: C-statistics 0.75 (0.73 to 0.77) and 0.75 (0.73 to 0.77), respectively, and for predicting for any stroke or systemic embolism over 1 year, C-statistics 0.68 (0.62 to 0.74). CONCLUSIONS: Performance of the GARFIELD-AF risk tool was superior to CHA2DS2-VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients. The GARFIELD-AF tool has the potential for incorporation in routine electronic systems, and for the first time, permits simultaneous evaluation of ischaemic stroke, mortality and bleeding risks. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362) and for ORBIT-AF (NCT01165710)