Citations

AbstractLinear regression is typically taught as a second and potentially last required (bio)statistics course for Public Health and Clinical and Translational Science students. There has been much research on the attitudes of students toward basic biostatistics, but there has not been much assessing students’ understanding of critical regression topics. The REGRESS (REsearch on Global Regression Expectations in StatisticS) quiz developed at Mayo Clinic utilizes 27 questions to assess understanding for simple and multiple linear regression. We performed an initial external validation of this tool with 117 University of Michigan public health students. We compare the results of pre‐ and postcourse quiz scores from the Michigan cohort to scores of Mayo medical students and professional statisticians. University of Michigan students performed higher than Mayo students on the precourse quiz due to previous related coursework, but did not perform as high postcourse indicating the need for course modification. In the Michigan cohort, REGRESS scores improved by a mean (standard deviation) of 4.6 (3.4), p < 0.0001. Our results support the use of the REGRESS quiz as a learning tool for students and an evaluation tool to identify topics for curricular improvement for teachers, while we highlight future directions of research.

Primary sclerosing cholangitis (PSC) is a rare, chronic, cholestatic liver disease in which emerging data suggest that oral antibiotics may offer therapeutic effects. We enrolled patients with PSC in a 12-week, open-label pilot study to investigate the efficacy and safety of 550 mg of oral rifaximin twice daily. The primary end point was serum alkaline phosphatase (ALK) at 12 weeks. Secondary end points included (1) serum bilirubin, gamma-glutamyl transpeptidase, and Mayo PSC risk score; (2) fatigue impact scale, chronic liver disease questionnaire, and short form health survey (SF-36) scores; and (3) adverse effects (AEs). Analyses were performed with nonparametric tests. Sixteen patients were enrolled, among whom the median age was 40 years; 13 (81%) were male, 13 had inflammatory bowel disease, and baseline ALK was 342 IU/mL (interquartile range, 275–520 IU/mL). After 12 weeks of treatment, there were no significant changes in ALK (median increase of 0.9% to 345 IU/mL; P = 0.47) or any of the secondary biochemical end points (all P > 0.05). Similarly, there were no significant changes in fatigue impact scale, chronic liver disease questionnaire, or SF-36 scores (all P > 0.05). Three patients withdrew from the study due to AEs; 4 others reported mild AEs but completed the study. In conclusion, although some antibiotics may have promise in treating PSC, oral rifaximin, based on the results herein, seems inefficacious for this indication. Future studies are needed to understand how the antimicrobial spectra and other properties of antibiotics might determine their utility in treating PSC.

AbstractIntroductionAlthough regression is widely used for reading and publishing in the medical literature, no instruments were previously available to assess students’ understanding. The goal of this study was to design and assess such an instrument for graduate students in Clinical and Translational Science and Public Health.MethodsA 27‐item REsearch on Global Regression Expectations in StatisticS (REGRESS) quiz was developed through an iterative process. Consenting students taking a course on linear regression in a Clinical and Translational Science program completed the quiz pre‐ and postcourse. Student results were compared to practicing statisticians with a master's or doctoral degree in statistics or a closely related field.ResultsFifty‐two students responded precourse, 59 postcourse , and 22 practicing statisticians completed the quiz. The mean (SD) score was 9.3 (4.3) for students precourse and 19.0 (3.5) postcourse (P < 0.001). Postcourse students had similar results to practicing statisticians (mean (SD) of 20.1(3.5); P = 0.21). Students also showed significant improvement pre/postcourse in each of six domain areas (P < 0.001). The REGRESS quiz was internally reliable (Cronbach's alpha 0.89).ConclusionThe initial validation is quite promising with statistically significant and meaningful differences across time and study populations. Further work is needed to validate the quiz across multiple institutions.

AbstractIntroductionSepsis biomarker research requires an infrastructure to identify septic patients efficiently and to collect and store specimens properly. We developed a novel infrastructure to study biomarkers of sepsis in children.MethodsPatients in pediatric and neonatal intensive care units were enrolled prospectively; enrollment information was stored in a secure, remotely accessible database. Researchers were notified of electronic medical record (EMR) orders for blood cultures (a surrogate for a diagnostic evaluation of suspected sepsis) by a page triggered by the order. Staff confirmed patient enrollment and remotely submitted an EMR order for collection of study specimens simultaneous with the blood culture. Specimens were processed and stored by a mobile clinical research unit.ResultsOver 2 years, 2029 patients were admitted; 138 were enrolled. Staff received pages for 95% of blood cultures collected from enrolled patients. The median time between the blood culture order and collection was 34 minutes (range 9–241). Study specimens were collected simultaneously with 41 blood cultures. The median times between specimen collection and storage for flow cytometry and cytokine analysis were 33 minutes (range 0–82) and 52 minutes (range 28–98), respectively.ConclusionThis novel infrastructure facilitated prompt, proper collection and storage of specimens for sepsis biomarker analysis. Clin Trans Sci 2012; Volume #: 1–5

SummaryBackgroundPatients with eosinophilic oesophagitis (EoE) commonly have asthma and atopy.AimsTo determine the predictive factors of EoE in patients with asthma.MethodsA retrospective analysis of a large database identified 156 asthma patients with EoE and 276 patients without EoE between 2000 and 2010. Clinical and laboratory characteristics were first analyzed in half of each group. Significant differences and modelling were then applied to the other half of each group in a split half analysis.ResultsOdds ratios and P‐values found to predict the presence of EoE in asthma patients were: allergic vs. non‐allergic asthma (4.07, <0.01), food allergies (45, <0.01), allergic rhinitis (2.13, =0.01) and peripheral eosinophilia (4.51, <0.01). The use of inhaled corticosteroids was negatively associated with EoE (0.41, <0.01) for asthma patients and (0.37, P < 0.01) for allergic type asthma patients. EoE patients were also younger (27.4 vs. 41.6 years old, P < 0.01). By logistic regression analysis, allergic asthma, presence of peripheral eosinophilia and use of inhaled steroids remained significant. From these parameters, a 3.5‐point scoring system model for EoE in asthma was formed with an ROC = 0.787 on split analysis.ConclusionsIn descending order, peripheral eosinophilia, allergic asthma and allergic rhinitis are associated with EoE in patients with asthma. Steroid inhalers appear to have a protective effect against EoE. An accurate and simple scoring system can be used as a screening tool to predict the presence of EoE in patients with asthma and dysphagia. EoE should be viewed as part of a generalised allergic phenotype rather than isolated oesophageal disease.

Background— In contrast to the wealth of data on isolated systolic hypertension involving the systemic circulation in the elderly, much less is known about age-related change in pulmonary artery systolic pressure (PASP) and its prognostic impact in the general population. We sought to define the relationship between PASP and age, to evaluate which factors influence PASP, and to determine whether PASP is independently predictive of mortality in the community. Methods and Results— A random sample of the Olmsted County, Minn, general population (n=2042) underwent echocardiography and spirometry and was followed up for a median of 9 years. PASP was measured from the tricuspid regurgitation velocity. Left ventricular diastolic pressure was estimated with Doppler echocardiography (E/e′ ratio), and arterial stiffening was assessed from the brachial artery pulse pressure. Among 1413 subjects (69%) with measurable PASP (age, 63±11 years; 43% male), median PASP was 26 mm Hg (25th to 75th percentile, 24 to 30 mm Hg) and increased with age ( r =0.31, P <0.001). Independent predictors of PASP were age, pulse pressure, and mitral E/e′ (all P ≤0.003). Increasing PASP was associated with higher mortality (hazard ratio, 2.73 per 10 mm Hg; P <0.001). In subjects without cardiopulmonary disease (any heart failure, coronary artery disease, hypertension, diabetes mellitus, or chronic obstructive lung disease), the age-adjusted hazard ratio was 2.74 per 10 mm Hg ( P =0.016). Conclusions— We provide the first population-based evidence of age-related increase in pulmonary artery pressure, its association with increasing left heart diastolic pressures and systemic vascular stiffening, and its negative impact on survival. Pulmonary artery pressure may serve as a novel cardiovascular risk factor and potential therapeutic target.

Background— The role of valve surgery in left-sided infective endocarditis has not been evaluated in randomized controlled trials. We examined the association between valve surgery and all-cause 6-month mortality among patients with left-sided infective endocarditis. Methods and Results— A total of 546 consecutive patients with left-sided infective endocarditis were included. To minimize selection bias, propensity score to undergo valve surgery was used to match patients in the surgical and nonsurgical groups. To adjust for survivor bias, we matched the follow-up time so that each patient in the nonsurgical group survived at least as long as the time to surgery in the respective surgically-treated patient. We also used valve surgery as a time-dependent covariate in different Cox models. A total of 129 (23.6%) patients underwent surgery within 30 days of diagnosis. Death occurred in 99 of the 417 patients (23.7%) in the nonsurgical group versus 35 deaths among the 129 patients (27.1%) in the surgical group. Eighteen of 35 (51%) patients in the surgical group died within 7 days of valve surgery. In the subset of 186 cases (93 pairs of surgical versus nonsurgical cases) matched on the logit of their propensity score, diagnosis decade, and follow-up time, no significant association existed between surgery and mortality (adjusted hazard ratio, 1.3; 95% confidence interval, 0.5 to 3.1). With a Cox model that incorporated surgery as a time-dependent covariate, valve surgery was associated with an increase in the 6-month mortality with an adjusted hazard ratio of 1.9 (95% confidence interval, 1.1 to 3.2). Because the proportionality hazard assumption was violated in the time-dependent analysis, we performed a partitioning analysis. After adjustment for early (operative) mortality, surgery was not associated with a survival benefit (adjusted hazard ratio, 0.92; 95% confidence interval, 0.48 to 1.76). Conclusions— The results of our study suggest that valve surgery in left-sided infective endocarditis is not associated with a survival benefit and could be associated with increased 6-month mortality, even after adjustment for selection and survivor biases as well as confounders. Given the disparity between the results of our study and those of other observational studies, well-designed prospective studies are needed to further evaluate the role of valve surgery in endocarditis management.