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Background Some patients with COVID-19 develop life-threatening thrombotic complications including myocardial infarction, deep vein thrombosis, pulmonary embolism, disseminated intravascular coagulation, and ischemic stroke. These inflammatory and hypercoagulable states have been well documented in patient cohorts from metropolitan areas, but not in more rural populations, nor has a data-driven treatment plan been developed for thrombotic COVID-19 patients. Methods We undertook a retrospective case-control study of COVID-19-positive patients to analyze the impact of thrombosis on various clinical endpoints including terminal diagnosis and disease severity. Prevalence and impact of thrombosis were determined using medical records from 2237 COVID-19-positive patients hospitalized in Cumberland County, North Carolina. Odds ratios for terminal diagnosis, death, ICU admission, and ventilation were calculated based on thrombosis status, D-dimer level, or type of antithrombotic treatment. Results Terminal diagnosis [OR 1.81; 95% CI (1.10, 2.98)], ICU admission [2.25; (1.33, 3.81)], and ventilation [2.46; (1.45, 4.18)] were all more likely in thrombotic patients (N = 97) compared to nonthrombotic patients (N = 2140) after adjusting for age. D-dimer levels were associated with death overall, but not among thrombotic patients. Treatments that combined antiplatelet and anticoagulant drugs appeared to be more efficacious than anticoagulants alone in preventing death and severe disease. Limitations Patient medical history prior to hospitalization was not evaluated. Conclusion In this cohort, those with thrombosis are at increased risk for adverse outcomes including death and severe disease. Antithrombotic therapy that includes antiplatelet drugs provides improved outcomes. Higher-powered prospective trials will be necessary to confirm any potential merits of antiplatelet therapy.

Introduction: The purpose of this study was to compare statistical knowledge of health science faculty across accredited schools of dentistry, medicine, nursing, pharmacy, and public health. Methods: A probability sample of schools was selected, and all faculty at each selected school were invited to participate in an online statistical knowledge assessment that covered fundamental topics including randomization, study design, statistical power, confidence intervals, multiple testing, standard error, regression outcome, and odds ratio. Results: A total of 708 faculty from 102 schools participated. The overall response rate was 6.5%. Most (94.2%) faculty reported reading the peer-reviewed health-related literature. Respondents answered 66.2% of questions correctly across all questions and disciplines. Public health had the highest performance (80.7%) and dentistry the lowest (53.3%). Conclusions: Knowledge of statistics is essential for critically evaluating evidence and understanding the health literature. These study results identify a gap in knowledge by educators tasked with training the next generation of health science professionals. Recommendations for addressing this gap are provided.

Objective The objective of this study was to determine if a difference exists in the proportion of visits for the prescribing of angiotensin converting enzyme inhibitors (ACEI), or angiotensin receptor blockers (ARBs) in diabetic patients during 2007–2010. Methods This retrospective, cross-sectional, observational study included adults diagnosed with diabetes mellitus from the National Ambulatory Medical Care Survey (NAMCS) during 2007–2010. Weighted chi-square tests and a multivariable logistic regression model were used to analyze associations between ACEI/ARB prescriptions and predictors of interest. Odds ratios and 95% confidence intervals were reported. Results An unweighted total of 13,590 outpatient ambulatory care visits were identified for adult patients with diabetes without contraindications to ACEIs or ARBs in the NAMCS for the years studied. No statistically significant increase in the proportion of visits with an ACEI/ARB prescription was identified for years 2007–2010 (28.1% in 2007 to 32.2% in 2010). Females (OR 0.78, 95% CI 0.69- 0.89), patients 18–39 years old (OR 0.56, 95% CI 0.43- 0.75), and Medicare users (OR 0.81, 95% CI 0.70- 0.94) were significantly less likely to receive an ACEI/ARB prescription. Patients with hypertension (OR 2.80, 95% CI 2.39-3.29), hyperlipidemia (OR 1.42, 95% CI 1.22-1.65), and ischemic heart disease (OR 1.36, 95% CI 1.10-1.70) were significantly more likely to receive an ACEI/ARB prescription. Conclusions Despite extensive evidence showing the benefits of ACEI/ARB medications in diabetic patients, disparities of treatment remain evident., Highlights • Assessed ACEI/ARB prescriptions in diabetic patients for ADA guideline adherence • A low percentage of patients prescribed an ACEI/ARB (28.1% in 2007–32.2% in 2010) • Females, age 18–39, and Medicare users less likely to receive ACEI/ARB prescription • Hypertension, hyperlipidemia and IHD: more likely to receive ACEI/ARB prescription • Disparities in ACEI/ARB prescriptions remain evident

BACKGROUND This study was designed to investigate whether racial and ethnic disparities in infant mortality still exist in North Carolina and to examine predictors of infant mortality using the North Carolina Vital Statistics Dataverse. METHODS This was a retrospective, cross-sectional, observational study that included all 257,543 births in North Carolina in 2008-2009. Infant mortality was assessed based on birth records included in the database. Infant births and deaths were summarized by demographic and maternal/infant characteristics. A multivariate logistic regression model was constructed to jointly assess predictors of infant mortality. RESULTS The overall infant mortality rate in North Carolina was 0.8%. Adjusting for confounders through the construction and assessment of a multivariate logistic regression model, statistically significant associations were found between infant mortality and each of the following: maternal race (both black and 'other' versus white), infant sex, both premature and preterm gestation (versus full term), birth weight (both low and high versus normal), maternal education (both less than high school graduate and more than high school versus college graduate), prenatal care (both intermediate and inadequate versus adequate), and maternal tobacco use. LIMITATIONS Maternal race was limited to white, black, and other. Data on socioeconomic status, maternal medical risk factors, and quality of prenatal care were not available. At the time of the analysis, data for years beyond 2009 were limited. CONCLUSIONS Racial disparities in infant mortality persist in North Carolina; specifically, infants of nonwhite mothers have a higher mortality rate than do infants of white mothers. Other factors that continue to play a significant role in infant mortality in North Carolina include preterm and premature births, male infant sex, low birth weight, maternal education less than college graduate, maternal tobacco use, and less than adequate prenatal care.

OBJECTIVE A clinically relevant approach to patient care grounded in neurobiological constructs and evidence based practice which emphasizes a relevant psychopharmacology is needed to optimally train psychiatry residents. METHODS We implemented a biological psychiatry course that now incorporates neurobiology, psychopharmacology, and evidence-based practice in conjunction with a Research Domain Criteria (RDoC) perspective. A survey launched prior to course implementation and following each class session, served as the outcome metric of residents' attitudes toward the new curriculum and followed a baseline attitudinal survey designed to evaluate the program. RESULTS Greater than 90% of the psychiatry residents at Duke University who took the attitudinal survey agreed or strongly agreed with needing a course that helped them develop an understanding of neurobiology, psychopharmacology, and evidence-based practice concepts. Most residents also indicated a less than adequate understanding of the neurobiology and psychopharmacology of psychiatric disorders prior to sessions. CONCLUSION Our biological psychiatry curriculum was associated with enthusiasm among residents regarding the incorporation of neurobiology, psychopharmacology, and evidence-based practice into course topics and discussions. A biological psychiatry curriculum with integrated neurobiology and psychopharmacology built on an evidence base approach is possible, well-received, and needed in training of future psychiatrists.

INTRODUCTION/BACKGROUND Zolpidem is a sedative-hypnotic widely prescribed in the United States. Recently, the US Food and Drug Administration (FDA) issued a drug safety communication regarding its dosing in women. OBJECTIVE To compare compliance with FDA-approved dosing for zolpidem in women before and after a drug safety communication, and to evaluate compliance based on pharmacy location and prescriber type. METHOD This was a retrospective, observational cohort study. New prescriptions for Ambien, Ambien CR, Edluar, or Zolpimist or their respective generics dispensed from Kerr Drug pharmacies in North Carolina to women 18-64 years of age between April and September of 2012 ("before" cohort) or April and September of 2013 ("after" cohort) were included. χ(2) tests were conducted to assess overall compliance, as well as compliance based on location (urban or rural) and prescriber type (physician or midlevel), with FDA-approved dosing for zolpidem. Trends in total prescription volume and total zolpidem prescription volume for all Kerr Drug pharmacies over the study period were also described. RESULTS A total of 14,156 prescriptions for zolpidem were included in the primary analysis. Sixteen percent of prescriptions dispensed were in compliance with FDA recommendations following the FDA alert. A statistically significant increase was observed in compliance with FDA-approved dosing for zolpidem (odds ratio = 1.49; 95% CI, 1.35-1.65; P < .0001) postdrug safety communication. Significant increases in compliance were also observed in the post-FDA communication subgroups based on location and prescriber type, though no subgroup was found to be significantly more compliant than another. CONCLUSIONS The release of a drug safety communication by the FDA resulted in a statistically significant increase in proper dosing of zolpidem in women. Further research is needed in order to determine the impact of FDA alerts on prescribing patterns and the reasons for therapeutic substitution after such alerts.

Recent studies have shown increased interest in measuring error rates in surgical pathology. We sought to determine how many surgical pathology cases need to be reviewed to show a significant difference from published error rates for review of routine or biopsy cases. Results of 4 series with this type of diagnostic material involving a total of 11,683 cases were reviewed to determine the range of published false-negative, false-positive, typing error, threshold error, and clinically significant error rates. Error rates ranged from 0.00% to 2.36%; clinically significant error rates ranged from 0.34% to 1.19%. Assuming a power of 0.80 and a 1-sided alpha of 0.05, the number of cases needed to be reviewed to show that a laboratory with either twice or one half the published error rate was significantly different from the range of published error rates varied from 3.30 to 50, 158. For clinically significant errors, the number of cases varied from 665 to 5,886. Because the published error rates are low, a relatively large number of cases need to be reviewed and a relatively great difference in error rate needs to exist to show a significant difference in performance in surgical pathology.

M-reps (formerly called DSLs) are a multiscale medial means for modeling and rendering 3D solid geometry. They are particularly well suited to model anatomic objects and in particular to capture prior geometric information effectively in deformable models segmentation approaches. The representation is based on figural models, which define objects at coarse scale by a hierarchy of figures—each figure generally a slab representing a solid region and its boundary simultaneously. This paper focuses on the use of single figure models to segment objects of relatively simple structure. A single figure is a sheet of medial atoms, which is interpolated from the model formed by a net, i.e., a mesh or chain, of medial atoms (hence the name m-reps), each atom modeling a solid region via not only a position and a width but also a local figural frame giving figural directions and an object angle between opposing, corresponding positions on the boundary implied by the m-rep. The special capability of an m-rep is to provide spatial and orientational correspondence between an object in two different states of deformation. This ability is central to effective measurement of both geometric typicality and geometry to image match, the two terms of the objective function optimized in segmentation by deformable models. The other ability of m-reps central to effective segmentation is their ability to support segmentation at multiple levels of scale, with successively finer precision. Objects modeled by single figures are segmented first by a similarity transform augmented by object elongation, then by adjustment of each medial atom, and finally by displacing a dense sampling of the m-rep implied boundary. While these models and approaches also exist in 2D, we focus on 3D objects. The segmentation of the kidney from CT and the hippocampus from MRI serve as the major examples in this paper. The accuracy of segmentation as compared to manual, slice-by-slice segmentation is reported.

In-house consultation is a well-known method to improve diagnostic accuracy and agreement, but the technique has not been well studied. We reviewed the results of in-house consultation in a large private hospital practice setting for a 1-month period and determined its effect on diagnostic accuracy using the final sign-out as the "gold standard." During this 1-month period, 352 cases were reviewed as in-house consultations. Initial complete agreement was found in 315 (89.5%) cases. Using the initial diagnosis as the test case and the final sign-out as the gold standard, of the 37 discrepant cases, 4 (1.1%) were thought to represent false-negative results, (0.3%) a false-positive result, 3 (0.9%) differences in type, and 29 (8.2%) differences in diagnostic threshold. Disagreements in 10 cases were thought to be potentially clinically significant. Internal consultation was obtained on approximately 20% of all cases seen in the laboratory and disagreements were found in 2% of all cases. Internal consultation has a significant and measurable impact on the practice of surgical pathology.

The significance of perineural invasion in prostate needle biopsy specimens for predicting extraprostatic extension is controversial. We correlated the presence of perineural invasion in needle biopsy specimens from 340 men with the presence of extraprostatic extension in corresponding radical prostatectomy specimens. Perineural invasion was present in 57 biopsy specimens. The sensitivity of perineural invasion for predicting extraprostatic extension was 32%, the specificity 88%, and the positive predictive value 42%. Biopsy specimens with perineural invasion had significantly more core specimens involved with tumor and higher biopsy-determined Gleason scores than those without invasion. Biopsy specimens with perineural invasion were significantly more likely to show extraprostatic extension and Gleason scores were higher in the resection specimens than those without perineural invasion. Multivariate logistic regression analysis showed that perineural invasion remained an independent predictor of extraprostatic extension. However, in multivariate analysis, including preoperative serum prostate-specific antigen (PSA) for 173 of the patients, the only independent predictor of extraprostatic extension was PSA. While perineural invasion in biopsy specimens is a predictor of extraprostatic extension at resection that is independent of other histologic features, the positive predictive value is low and it is not an independent predictor when serum PSA is included.

M-reps (formerly called DSLs) are a multiscale medial means for modeling and rendering 3D solid geometry. They are particularly well suited to model anatomic objects and in particular to capture prior geometric information effectively in deformable models segmentation approaches. The representation is based on figural models, which define objects at coarse scale by a hierarchy of figures – each figure generally a slab representing a solid region and its boundary simultaneously. This paper focuses on the use of single figure models to segment objects of relatively simple structure.

Context.—Several studies have shown that blinded review, because it is less biased and may improve vigilance, is an excellent method for detecting errors and improving performance in gynecologic cytology. The value of blinded review in surgical pathology is not known. Objective.—To determine the value of blinded review in surgical pathology. Methods.—Five hundred ninety-two biopsy cases were reviewed without knowledge of the original diagnosis or history, and the results were compared with those of the original diagnosis. Results.—Complete agreement was obtained in 567 (96%) of 592 cases. The technique of blinded review of biopsy material had a sensitivity of 98%, failing to identify a lesion in 7 cases; no cases of malignancy were missed. The specificity was 100%. Differences in diagnostic threshold were the most common source of disagreement. False-negative cases were identified by the technique and were clinically significant. Power studies show that the number of cases requiring review to identify significant errors are large, but potentially achievable by blinded review. Conclusion.—Blinded review is a sensitive and effective method for identifying areas of disagreement, including false-negative cases, and for decreasing errors in surgical pathology biopsy material.

Scientists often need to test hypotheses and construct corresponding confidence intervals. In designing a study to test a particular null hypothesis, traditional methods lead to a sample size large enough to provide sufficient statistical power. In contrast, traditional methods based on constructing a confidence interval lead to a sample size likely to control the width of the interval. With either approach, a sample size so large as to waste resources or introduce ethical concerns is undesirable. This work was motivated by the concern that existing sample size methods often make it difficult for scientists to achieve their actual goals. We focus on situations which involve a fixed, unknown scalar parameter representing the true state of nature. The width of the confidence interval is defined as the difference between the (random) upper and lower bounds. An event width is said to occur if the observed confidence interval width is less than a fixed constant chosen a priori. An event validity is said to occur if the parameter of interest is contained between the observed upper and lower confidence interval bounds. An event rejection is said to occur if the confidence interval excludes the null value of the parameter. In our opinion, scientists often implicitly seek to have all three occur: width, validity, and rejection. New results illustrate that neglecting rejection or width (and less so validity) often provides a sample size with a low probability of the simultaneous occurrence of all three events. We recommend considering all three events simultaneously when choosing a criterion for determining a sample size. We provide new theoretical results for any scalar (mean) parameter in a general linear model with Gaussian errors and fixed predictors. Convenient computational forms are included, as well as numerical examples to illustrate our methods.

Purpose : Computer-assisted methods to analyze electronic portal images for the presence of treatment setup errors should be studied in controlled experiments before use in the clinical setting. Validation experiments using images that contain known errors usually report the smallest errors that can be detected by the image analysis algorithm. This paper offers human error-detection thresholds as one benchmark for evaluating the smallest errors detected by algorithms. Unfortunately, reliable data are lacking describing human performance. The most rigorous benchmarks for human performance are obtained under conditions that favor error detection. To establish such benchmarks, controlled observer studies were carried out to determine the thresholds of detectability for in-plane and out-of-plane translation and rotation setup errors introduced into digitally reconstructed portal radiographs (DRPRs) of prostate fields. Methods and Materials : Seventeen observers comprising radiation oncologists, radiation oncology residents, physicists, and therapy students participated in a two-alternative forced choice experiment involving 378 DRPRs computed using the National Library of Medicine Visible Human data sets. An observer viewed three images at a time displayed on adjacent computer monitors. Each image triplet included a reference digitally reconstructed radiograph displayed on the central monitor and two DRPRs displayed on the flanking monitors. One DRPR was error free. The other DRPR contained a known in-plane or out-of-plane error in the placement of the treatment field over a target region in the pelvis. The range for each type of error was determined from pilot observer studies based on a Probit model for error detection. The smallest errors approached the limit of human visual capability. The observer was told what kind of error was introduced, and was asked to choose the DRPR that contained the error. Observer decisions were recorded and analyzed using repeated-measures analysis of variance. Results : The thresholds of detectability averaged over all observers were approximately 2.5 mm for in-plane translations, 1.6° for in-plane rotations, 1° for out-of-plane rotations, and 8% change in magnification for out-of-plane translations along the central axis. When one inexperienced observer is excluded, the average threshold for change in magnification is 5%. Experienced observers tended to perform better, but differences between groups were not statistically significant. Thresholds were computed as averages over all observers. Because of the broad range of observer capabilities, some detection tasks were too difficult for some observers, leading to missing threshold values in our data analysis. The missing values were excluded from computation of the average thresholds reported above. The effect of the missing values is to bias the average values toward the best human performance. Conclusions : Under favorable conditions, humans can detect small errors in setup geometry. The thresholds for error detection reported in this study are believed to represent rigorous but reasonable benchmarks that can be incorporated into studies evaluating algorithms for computer-assisted detection of setup errors in electronic portal images.

We report the results of a randomized, controlled tnal to compare the accuracy of standard ultrasound-guided needle biopsy to biopsies performed using a 3D Augmented Reality (AR) guidance system. Fifty core biopsies of breast phantoms were conducted by a board-certified radiologist, with each set of five biopsies randomly assigned to one of the methods. The raw ultrasound data from each biopsy was recorded. Another board-certified radiologist, blinded to the actual biopsy guidance mechanism, evaluated the ultrasound recordings and determined the distance of the biopsy from the ideal position. A repeated measures analysis of variance indicated that the head-mounted display method led to a statistically significantly smaller mean deviation from the desired target than did the CRT display method. (2.48mm for control versus 1.62mm for augmented reality, p < 0.02). This result suggests that AR systems can offer improved accuracy over traditional biopsy guidance methods.