Outcomes after intervention for enteral nutrition in patients with amyotrophic lateral sclerosis in multidisciplinary clinics.

INTRODUCTION/AIMS: Patients with amyotrophic lateral sclerosis (ALS) are susceptible to malnutrition, with appropriate management of nutritional interventions an active area of investigation. We sought to determine the impact of gastrostomy tube placement in ALS patients, exploring the correlation between forced vital capacity (FVC), malnutrition, and perioperative complications. METHODS: A retrospective review was performed of clinically diagnosed ALS patients treated at two multidisciplinary clinics (University of Kansas, University of Nebraska) from January 2009 to September 2020 who were referred for gastrostomy. Data collected included demographics, disease characteristics, and key gastrostomy related dates/outcomes. RESULTS: Two hundred thirty-nine patients were included with a median age of 65 years and median of 589 days from symptom onset to gastrostomy (interquartile range, 404-943). The population was predominantly Non-Hispanic White with bulbar-onset ALS. 30-day mortality was 4% and 30-day morbidity was 13%. Weight loss, body mass index, and predicted FVC at placement showed no increased 30-day morbidity or mortality association. Bulbar-onset ALS patients exhibited higher overall mortality postplacement than limb onset (odds ratio: 1.85, 95% confidence interval: 1.03-3.33). There was a 5% incidence of symptoms suggestive of refeeding syndrome. DISCUSSION: Rates of major/minor complications and 30-day mortality related to gastrostomy placement in our population were similar compared with prior studies in ALS. The lack of difference in outcomes based on FVC at procedure may suggest this is not predictive of outcome, or perhaps, high-quality perioperative respiratory management. Alternative reasons may account for the increased morbidity and mortality of gastrostomy placement in the ALS population.

Accurate Medication Adherence Measurement Using Administrative Data for Frequently Hospitalized Patients.

Background: Pharmacy administrative claims data remain an accessible and efficient source to measure medication adherence for frequently hospitalized patient populations that are systematically excluded from the landmark drug trials. Published pharmacotherapy studies use medication possession ratio (MPR) and proportion of days covered (PDC) to calculate medication adherence and usually fail to incorporate hospitalization and prescription overlap/gap from claims data. To make the cacophony of adherence measures clearer, this study created a refined hospital-adjusted algorithm to capture pharmacotherapy adherence among patients with end-stage renal disease (ESRD). Methods: The United States Renal Data System (USRDS) registry of ESRD was used to determine prescription-filling patterns of those receiving new prescriptions for oral P2Y12 inhibitors (P2Y12-I) between 2011 and 2015. P2Y12-I-naïve patients were followed until death, kidney transplantation, discontinuing medications, or loss to follow-up. After flagging/censoring key variables, the algorithm adjusted for hospital length of stay (LOS) and medication overlap. Hospital-adjusted medication adherence (HA-PDC) was calculated and compared with traditional MPR and PDC methods. Analyses were performed with SAS software. Results: Hospitalization occurred for 78% of the cohort (N = 46 514). The median LOS was 12 (interquartile range [IQR] = 2-34) days. MPR and PDC were 61% (IQR = 29%-94%) and 59% (IQR = 31%-93%), respectively. After applying adjustments for overlapping coverage days and hospital stays independently, HA-PDC adherence values changed in 41% and 52.7% of the cohort, respectively. When adjustments for overlap and hospital stay were made concurrently, HA-PDC adherence values changed in 68% of the cohort by 5.8% (HA-PDC median = 0.68, IQR = 0.31-0.93). HA-PDC declined over time (3M-6M-9M-12M). Nearly 48% of the cohort had a ≥30 days refill gap in the first 3 months, and this increased over time (P < .0001). Conclusions: Refill gaps should be investigated carefully to capture accurate pharmacotherapy adherence. HA-PDC measures increased adherence substantially when adjustments for hospital stay and medication refill overlaps are made. Furthermore, if hospitalizations were ignored for medications that are included in Medicare quality measures, such as Medicare STAR program, the apparent reduction in adherence might be associated with lower quality and health plan reimbursement.

Shorter length of hospital stay for hip fracture in those with dementia and without a known diagnosis of osteoporosis in the USA.

BACKGROUND: About 50% of all hospitalized fragility fracture cases in older Americans are hip fractures. Approximately 3/4 of fracture-related costs in the USA are attributable to hip fractures, and these are mostly covered by Medicare. Hip fracture patients with dementia, including Alzheimer's disease, have worse health outcomes including longer hospital length of stay (LOS) and charges. LOS and hospital charges for dementia patients are usually higher than for those without dementia. Research describing LOS and acute care charges for hip fractures has mostly focused on these outcomes in trauma patients without a known pre-admission diagnosis of osteoporosis (OP). Lack of documented diagnosis put patients at risk of not having an appropriate treatment plan for OP. Whether having a diagnosis of OP would have an effect on hospital outcomes in dementia patients has not been explored. We aim to investigate whether having a diagnosis of OP, dementia, or both has an effect on LOS and hospital charges. In addition, we also report prevalence of common comorbidities in the study population and their effects on hospital outcomes. METHODS: We conducted a cross-sectional analysis of claims data (2012-2013) for 2175 Medicare beneficiaries (≥65 years) in the USA. RESULTS: Compared to those without OP or dementia, patients with demenia only had a shorter LOS (by 5%; P = .04). Median LOS was 6 days (interquartile range [IQR]: 5-7), and the median hospital charges were $45,100 (IQR: 31,500 - 65,600). In general, White patients had a shorter LOS (by 7%), and those with CHF and ischemic heart disease (IHD) had longer LOS (by 7 and 4%, respectively). Hospital charges were 6% lower for women, and 16% lower for White patients. CONCLUSION: This is the first study evaluating LOS in dementia in the context of hip fracture which also disagrees with previous reporting about longer LOS in dementia patients. Patients with CHF and IHD remains at high risk for longer LOS regardless of their diagnosis of dementia or OP.

Trends for and Clinical Factors Associated with Choice of Oral P2Y12 Inhibitors for Patients on Chronic Dialysis.

BACKGROUND: Trends and clinical factors associated with prescribing choices for oral P2Y12 inhibitors (P2Y12-I) remain unknown for patients on chronic dialysis, i.e., with end-stage renal disease (ESRD). METHODS: From 2011-2014 U.S. Renal Data System registry, we identified 36,542 ESRD patients who received new prescriptions for P2Y12-I (median age 64.0 years and 54% males). Of the cohort, 93% were receiving hemodialysis and 7% on peritoneal dialysis. We analyzed trends and investigated clinical factors associated with specific P2Y12-I prescribed. RESULTS: Clopidogrel was prescribed for 95%, prasugrel for 3%, and ticagrelor for 2%. Clopidogrel was favored for those ≥75 years (18% of cohort). Compared to Caucasians, African Americans (36% of cohort) and Hispanics (19% of cohort) were less likely to receive prasugrel and ticagrelor (P<0.05). Patients receiving hemodialysis versus peritoneal dialysis were less likely to receive prasugrel over clopidogrel, adjusted odds ratio (aOR) 0.67 (0.55-0.82). Each additional year of dialysis decreased the odds of receiving prasugrel over clopidogrel, aOR 0.91 (0.85-0.98). History of atrial fibrillation reduced the odds of receiving ticagrelor or prasugrel over clopidogrel, aOR 0.69 (0.54-0.89) and 0.73 (0.60-0.89), respectively. Concomitant oral anticoagulant use was not associated with choice of P2Y12-I. Occurrence of non-ST segment elevation myocardial infarction or percutaneous coronary intervention within the 6-month period prior to the index date favored ticagrelor over prasugrel, aOR 1.31 (1.06-1.62) and 1.29 (1.01-1.66), respectively. However, prescribing trends favoring ticagrelor over prasugrel were not observed for deployment of drug-eluting, or multiple coronary stents. CONCLUSION: Between 2011 and 2014, clopidogrel remained the most common P2Y12-I whereas ticagrelor and prasugrel remained underutilized in ESRD patients. Prescribing practices for these drugs were based upon clinically approved indication for their use in the general population as well as perceived complexity of an ESRD patient including demographics, dialysis-related factors and comorbidities. Comparative effectiveness studies involving ESRD patients are needed to prove that ticagrelor and prasugrel are just as safe and effective as clopidogrel before clinicians can make informed decisions for choice of P2Y12-I in this patient population.

Radiographic signs of hook of hamate fracture: evaluation of diagnostic utility.

OBJECTIVE: Hook of hamate fracture, the most common swing-related wrist fracture, is commonly seen in high-level athletes. The fracture is rarely diagnosed on routine wrist radiographs, thus generally requiring CT or MR for diagnosis. Surgical excision has a high success rate, however diagnostic delay contributes to a high complication rate. Radiographic signs of hook of hamate fracture have been published, but uncertainty of the diagnostic accuracy limits application. The purpose of this study is to determine accuracy and interobserver reliability of radiographic signs of hook of hamate. MATERIALS AND METHODS: This retrospective case-control study evaluated wrist radiographs of 50 patients, including 24 positive and 26 negative, for hook of hamate fracture, each proven by CT or MR. Five reviewers performed blinded, randomized evaluation of radiographs documenting whether the hook of hamate was normal or fractured, and if fractured, the radiographic signs present (ring sign, ghostly shadow, and diffuse sclerosis) and views that contributed to diagnosis. RESULTS: Radiographic signs demonstrated high sensitivity (85%; 95% CI: 77-91), specificity (92%; 95% CI: 86-96), and accuracy (89%; 95% CI: 84-92) with substantial interobserver reliability (k = 0.652). The ring sign was the most sensitive radiographic sign. Diagnosis was most often supported by the oblique view (38%) and rarely the lateral view (15%). CONCLUSIONS: Radiographic signs of hook of hamate fracture on routine radiographs can accurately and reliably diagnose hook of hamate fractures. Evaluation for discontinuity of the cortical ring will optimize sensitivity, allowing for timely diagnosis and treatment, and a reduction of complications.

The Utility of a Benign Biliary Stricture Protocol in Preventing Symptomatic Recurrence and Surgical Revision.

PURPOSE: To determine whether treating benign biliary strictures via a stricture protocol reduced the probability of developing symptomatic recurrence and requiring surgical revision compared to nonprotocol treatment. MATERIALS AND METHODS: A stricture protocol was designed to include serial upsizing of internal/external biliary drainage catheters to a target maximum dilation of 18-French, optional cholangioplasty at each upsizing, and maintenance of the largest catheter for at least 6 months. Patients were included in this retrospective analysis if they underwent biliary ductal dilation at a single institution from 2005 to 2016. Forty-two patients were included, 25 women and 17 men, with an average age of 51.9 years (standard deviation ± 14.6). Logistic regression models were used to determine the probability of symptomatic recurrence and surgical revision by stricture treatment type. RESULTS: Twenty-two patients received nonprotocol treatment, while 20 received treatment on a stricture protocol. After treatment, 7 (32%) patients in the nonprotocol group experienced clinical or laboratory recurrence of a benign stricture, whereas only 1 patient in the stricture protocol group experienced symptom recurrence. Patients in the protocol group were 8.9 times (95% confidence interval [CI] = 1.4-175.3) more likely to remain symptom free than patients in the nonprotocol group. Moreover, patients in the protocol group had an estimated 89% reduction in the probability of undergoing surgical revision compared to patients receiving nonprotocol treatment (odds ratio = .11, 95% CI = .01-.73). CONCLUSIONS: Establishing a stricture protocol may decrease the risk of stricture recurrence and the need for surgical revision when compared to a nonprotocol treatment approach.

Of Mice and Roentgen: Radiologist Satisfaction with a Non-conventional 13-Button Mouse-One Institution's Experience.

Increasing radiologic exam volume and complexity necessitates leveraging advanced hardware solutions to optimize workflow efficiency. We evaluated radiologist satisfaction of a programmable 13-button non-conventional mouse compared to a conventional three-button mouse in daily interpretation workflow following a brief 2-day trial period. A prospective study was conducted with radiology staff and residents in a tertiary care center from 2015 to 2016. A survey was distributed prior to and after a tutorial and a 2-day non-conventional mouse trial period. The post-survey evaluated usage time, device settings, satisfaction, preferences, and perceived efficiency of both mice. Descriptive analyses, correlations, the Sign test, and the Wilcoxon signed-rank test were used to evaluate responses. Fifty-nine participants completed pre- and post-surveys. Several (41%, n = 24) had prior experience with a non-conventional mouse. Prior to the trial, one third of all participants (35.6%, n = 21) reported being satisfied or very satisfied with their conventional mouse. After spending an average of 9.8 h using the non-conventional mouse, there were no statistically significant changes in overall satisfaction with either conventional or non-conventional mice (p = 0.84 and p = 0.39, respectively). However, 76.3% (n = 45) agreed/somewhat agreed they preferred to use the non-conventional mouse in their daily workflow as opposed to the conventional mouse. The non-conventional mouse was also perceived as more efficient (66.1%, n = 39), required less time (62.7%, n = 37) and effort (74.6%, n = 44) to view images, allowed for easier manipulation of windows/images (76.3%, n = 45), and was more comfortable to use (78.0%, n = 46). Although there were no statistically significant shifts in overall satisfaction, participants reported a higher level of satisfaction, perceived efficiency, and preference for a non-conventional 13-button mouse compared to a conventional three-button mouse following a brief, 2-day trial period.

Physical activity and academic achievement across the curriculum: Results from a 3-year cluster-randomized trial.

We compared changes in academic achievement across 3years between children in elementary schools receiving the Academic Achievement and Physical Activity Across the Curriculum intervention (A+PAAC), in which classroom teachers were trained to deliver academic lessons using moderate-to-vigorous physical activity (MVPA) compared to a non-intervention control. Elementary schools in eastern Kansas (n=17) were cluster randomized to A+PAAC (N=9, target ≥100min/week) or control (N=8). Academic achievement (math, reading, spelling) was assessed using the Wechsler Individual Achievement Test-Third Edition (WIAT-III) in a sample of children (A+PAAC=316, Control=268) in grades 2 and 3 at baseline (Fall 2011) and repeated each spring across 3years. On average 55min/week of A+PACC lessons were delivered each week across the intervention. Baseline WIAT-III scores (math, reading, spelling) were significantly higher in students in A+PAAC compared with control schools and improved in both groups across 3years. However, linear mixed modeling, accounting for baseline between group differences in WIAT-III scores, ethnicity, family income, and cardiovascular fitness, found no significant impact of A+PAAC on any of the academic achievement outcomes as determined by non-significant group by time interactions. A+PAAC neither diminished or improved academic achievement across 3-years in elementary school children compared with controls. Our target of 100min/week of active lessons was not achieved; however, students attending A+PAAC schools received an additional 55min/week of MVPA which may be associated with both physical and mental health benefits, without a reduction in time devoted to academic instruction.

P2Y12 Inhibitors Refill Gap Predicts Death in Medicare Beneficiaries on Chronic Dialysis.

Introduction: Oral P2Y12 inhibitors (P2Y12-I) are commonly used antiplatelet drugs in patients with end-stage kidney disease (ESKD) on chronic dialysis. Although gaps in prescription refills are quite common in patients with ESKD, it remains unclear whether P2Y12-I prescription refill patterns are associated with adverse clinical outcomes. Methods: We used the United States Renal Data System (USRDS) registry for patients with ESKD to capture new P2Y12-I prescriptions from 2011 to 2015. The primary exposure was prescription refill patterns and the primary outcome was all-cause death. Results: Among the 31,243 patients with new P2Y12-I prescription, median age was 64 years; 54% were male; and 39% were Caucasian, 37% African American, and 18% Hispanic. We observed 3 P2Y12-I refill patterns as follows: continuous users (45.1%), noncontinuous users (3.6%), and users with ≥30 days refill gap (51.4%). Prescription refill pattern with ≥30 days refill gap (vs. continuous use) was associated with all-cause death (adjusted hazard ratio [HR]: 1.18; 95% confidence interval [CI]: 1.13-1.23). Age and race were the most important risk factors associated with prescription refill pattern. African Americans (vs. Caucasians) were more likely to demonstrate ≥30 days refill gap, (adjusted odds ratio [OR]: 1.43; 95% CI: 1.36-1.51). In addition, younger patients (vs. older) were more likely to demonstrate ≥30 day refill gap (adjusted OR/decade: 0.9; 95% CI: 0.89-0.92). Conclusion: Nonadherence to P2Y12-I prescriptions is quite common, and disproportionately affects minorities. Younger individuals with ESKD are independently associated with a higher risk of death. The odds of having a refill gap are decreasing for older patients who are more compliant than younger patients. Future studies should investigate whether phenotyping subgroups of patients with ESKD based on prescription refill patterns can help in improving adverse clinical outcomes.

Resistance exercise in early-stage ALS patients, ALSFRS-R, Sickness Impact Profile ALS-19, and muscle transcriptome: a pilot study.

Amyotrophic lateral sclerosis (ALS) patients lack effective treatments to maintain motor and neuromuscular function. This study aimed to evaluate the effect of a home-based exercise program on muscle strength, ALS scores, and transcriptome in ALS patients, Clinical Trials.gov #NCT03201991 (28/06/2017). An open-label, non-randomized pilot clinical trial was conducted in seven individuals with early-stage ALS. Participants were given 3 months of home-based resistance exercise focusing on the quadriceps muscles. The strength of exercised muscle was evaluated using bilateral quadriceps strength with manual muscle testing, handheld dynamometers, five times sit-to-stand, and Timed-Up-and-Go before and after the exercise program. In addition, changes in the Sickness Impact Profile ALS-19 (SIP/ALS-19) as the functional outcome measure and the transcriptome of exercised muscles were compared before and after the exercise. The primary outcome of muscle strength did not change significantly by the exercise program. The exercise program maintained the SIP/ALS-19 and the ALS Functional Rating Scale-Revised (ALSFRS-R). Transcriptome analysis revealed that exercise reverted the expression level of genes decreased in ALS, including parvalbumin. Three months of moderately intense strength and conditioning exercise maintained muscle strength of the exercised muscle and ALSFRS-R scores and had a positive effect on patients' muscle transcriptome.

A Disclosure About Death Disclosure: Variability in Circulatory Death Determination.

INTRODUCTION: Circulatory-respiratory death declaration is a common duty of physicians, but little is known about the amount of education and physician practice patterns in completing this examination. METHODS: An online survey of physicians was conducted evaluating the rate of formal training and specific examination techniques used in the pronouncement of circulatory-respiratory death. Data, including the level of practice, training received in a formal death declaration, and examination components, were collected. RESULTS: Respondents were attending physicians (52.4%), residents (30.2%), fellows (10.7%), and interns (6.7%). Most respondents indicated they had received no formal training in death pronouncement; however, most reported self-perceived competence. When comparing examination components used by the study's cohort, 95 different examination combinations were used for death pronouncement. CONCLUSIONS: Formal training in death pronouncement was uncommon and clinical practice varied. Implementation of formal training and standardization of the examination are necessary to improve physician competence and reliability in death declarations.

Comparative Effectiveness and Safety of Oral P2Y12 Inhibitors in Patients on Chronic Dialysis.

INTRODUCTION: Although oral P2Y12 inhibitors (P2Y12-Is) are one of the most commonly prescribed medication classes in patients with end stage kidney disease on dialysis (ESKD), scarce data exist regarding their benefits and risks. METHODS: We compared effectiveness and safety of clopidogrel, prasugrel, and ticagrelor in a longitudinal study using the United States Renal Data System registry of Medicare beneficiaries with ESKD. Individuals who filled new P2Y12-I prescriptions between 2011 and 2015 were included and followed until death or censoring. The primary exposure variable was P2Y12-I assignment. The primary outcome variable was death. Secondary outcomes included cardiovascular (CV) death, coronary revascularization, and gastrointestinal (GI) hemorrhage. Survival analyses were performed after propensity matching. RESULTS: Of 44,619 patients with ESKD who received P2Y12-Is, 95% received clopidogrel (n = 42,523), 3% prasugrel (n = 1205), and 2% ticagrelor (n = 891). To balance baseline differences, propensity-matching was performed: 1:6 for prasugrel (n = 1189) versus clopidogrel (n = 7134); 1:4 for ticagrelor (n = 880) versus clopidogrel (n = 3520); and 1:1 for ticagrelor versus prasugrel (n = 880). Prasugrel was associated with a reduced risk for death versus clopidogrel and ticagrelor (adjusted hazard ratio [HR] = 0.82; 95% CI: 0.73-0.93 and 0.78; 95% CI: 0.64-0.95). Compared with clopidogrel, prasugrel reduced risk for coronary revascularization (HR = 0.91; 95% CI: 0.86-0.96). There were no differences in GI hemorrhage between P2Y12-Is. CONCLUSION: In patients with ESKD, prasugrel compared with others reduced risk of death possibly by reducing risk for coronary revascularizations and without worsening gastrointestinal hemorrhage. Future trials are imperative to compare efficacy and safety of P2Y12-Is in patients with ESKD.

CONSENSUS: a Shiny application of dementia evaluation and reporting for the KU ADC longitudinal Clinical Cohort database.

BACKGROUND: The University of Kansas Alzheimer's Disease Center (KU ADC) maintains several large databases to track participant recruitment, enrollment, and capture various research-related activities. It is challenging to manage and coordinate all the research-related activities. One of the crucial activities involves generating a consensus diagnosis and communicating with participants and their primary care providers. PROCESS: To effectively manage the cohort, the KU ADC utilizes a combination of open-source electronic data capture (EDC) (i.e. REDCap), along with other homegrown data management and analytic systems developed using R-studio and Shiny. PROCESS EVALUATION: In this article, we describe the method and utility of the user-friendly dashboard that was developed for the rapid reporting of dementia evaluations which allows clinical researchers to summarize recruitment metrics, automatically generate letters to both participants and healthcare providers, which ultimately help optimize workflows. CONCLUSIONS: We believe this general framework would be beneficial to any institution that build reports and summarizing key metrics of their research from longitudinal databases.

Effect of aerobic exercise on amyloid accumulation in preclinical Alzheimer's: A 1-year randomized controlled trial.

BACKGROUND: Our goal was to investigate the role of physical exercise to protect brain health as we age, including the potential to mitigate Alzheimer's-related pathology. We assessed the effect of 52 weeks of a supervised aerobic exercise program on amyloid accumulation, cognitive performance, and brain volume in cognitively normal older adults with elevated and sub-threshold levels of cerebral amyloid as measured by amyloid PET imaging. METHODS AND FINDINGS: This 52-week randomized controlled trial compared the effects of 150 minutes per week of aerobic exercise vs. education control intervention. A total of 117 underactive older adults (mean age 72.9 [7.7]) without evidence of cognitive impairment, with elevated (n = 79) or subthreshold (n = 38) levels of cerebral amyloid were randomized, and 110 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. We conducted 18F-AV45 PET imaging of cerebral amyloid and anatomical MRI for whole brain and hippocampal volume at baseline and Week 52 follow-up to index brain health. Neuropsychological tests were conducted at baseline, Week 26, and Week 52 to assess executive function, verbal memory, and visuospatial cognitive domains. Cardiorespiratory fitness testing was performed at baseline and Week 52 to assess response to exercise. The aerobic exercise group significantly improved cardiorespiratory fitness (11% vs. 1% in the control group) but there were no differences in change measures of amyloid, brain volume, or cognitive performance compared to control. CONCLUSIONS: Aerobic exercise was not associated with reduced amyloid accumulation in cognitively normal older adults with cerebral amyloid. In spite of strong systemic cardiorespiratory effects of the intervention, the observed lack of cognitive or brain structure benefits suggests brain benefits of exercise reported in other studies are likely to be related to non-amyloid effects. TRIAL REGISTRATION: NCT02000583; ClinicalTrials.gov.

Evaluator Agreement in Medical Student Assessment Across a Multi-Campus Medical School During a Standardized Patient Encounter.

PURPOSE: Class rank and clerkship grades impact a medical student's residency application. The variability and inter-rater reliability in assessment across multiple clinical sites within a single university system is unknown. We aimed to determine if medical student assessment across medical school campuses is consistent when using a standardized scoring rubric. DESIGN/METHODS: Attending physicians who participate in assignment of clerkship grades for neurology from three separate clinical campuses of the same medical school observed 10 identical standardized patient encounters completed by third year medical students during the 2017-2018 academic year. Scoring was completed using a standardized rubric. Descriptive analysis and intra-rater comparisons were completed. Evaluations as a part of this study were completed in 2018. RESULTS: Of 50 possible points for the patient encounter, the median score among all medical students and all evaluators was 43 (IQR 40, 45.5). Evaluator number 1 provided a statistically significant lower overall score as compared to evaluators 2 and 3 (p = 0.0001 and p = 0.0006, respectively), who were consistently similar in their overall medical student assessment (p = 0.46). Overall agreement between evaluators was good (ICC = 0.805, 95% CI 0.36-0.95) and consistency was excellent (ICC = 0.91, 95% CI 0.75-0.97). CONCLUSIONS: Medical student evaluation across multiple clinical campus sites via observation of identical standardized patient encounters and use of a standardized scoring rubric generally demonstrated good inter-rater agreement and consistency, but the small variation seen may affect overall clerkship scores.

A semi-automated pipeline for fulfillment of resource requests from a longitudinal Alzheimer's disease registry.

OBJECTIVE: Managing registries with continual data collection poses challenges, such as following reproducible research protocols and guaranteeing data accessibility. The University of Kansas (KU) Alzheimer's Disease Center (ADC) maintains one such registry: Curated Clinical Cohort Phenotypes and Observations (C3PO). We created an automated and reproducible process by which investigators have access to C3PO data. MATERIALS AND METHODS: Data was input into Research Electronic Data Capture. Monthly, data part of the Uniform Data Set (UDS), that is data also collected at other ADCs, was uploaded to the National Alzheimer's Coordinating Center (NACC). Quarterly, NACC cleaned, curated, and returned the UDS to the KU Data Management and Statistics (DMS) Core, where it was stored in C3PO with other quarterly curated site-specific data. Investigators seeking to utilize C3PO submitted a research proposal and requested variables via the publicly accessible and searchable data dictionary. The DMS Core used this variable list and an automated SAS program to create a subset of C3PO. RESULTS: C3PO contained 1913 variables stored in 15 datasets. From 2017 to 2018, 38 data requests were completed for several KU departments and other research institutions. Completing data requests became more efficient; C3PO subsets were produced in under 10 seconds. DISCUSSION: The data management strategy outlined above facilitated reproducible research practices, which is fundamental to the future of research as it allows replication and verification to occur. CONCLUSION: We created a transparent, automated, and efficient process of extracting subsets of data from a registry where data was changing daily.

Augmenting Amyloid PET Interpretations With Quantitative Information Improves Consistency of Early Amyloid Detection.

PURPOSE: Establishing reliable methods for interpreting elevated cerebral amyloid-ß plaque on PET scans is increasingly important for radiologists, as availability of PET imaging in clinical practice increases. We examined a 3-step method to detect plaque in cognitively normal older adults, focusing on the additive value of quantitative information during the PET scan interpretation process. METHODS: Fifty-five F-florbetapir PET scans were evaluated by 3 experienced raters. Scans were first visually interpreted as having "elevated" or "nonelevated" plaque burden ("Visual Read"). Images were then processed using a standardized quantitative analysis software (MIMneuro) to generate whole brain and region of interest SUV ratios. This "Quantitative Read" was considered elevated if at least 2 of 6 regions of interest had an SUV ratio of more than 1.1. The final interpretation combined both visual and quantitative data together ("VisQ Read"). Cohen kappa values were assessed as a measure of interpretation agreement. RESULTS: Plaque was elevated in 25.5% to 29.1% of the 165 total Visual Reads. Interrater agreement was strong (kappa = 0.73-0.82) and consistent with reported values. Quantitative Reads were elevated in 45.5% of participants. Final VisQ Reads changed from initial Visual Reads in 16 interpretations (9.7%), with most changing from "nonelevated" Visual Reads to "elevated." These changed interpretations demonstrated lower plaque quantification than those initially read as "elevated" that remained unchanged. Interrater variability improved for VisQ Reads with the addition of quantitative information (kappa = 0.88-0.96). CONCLUSIONS: Inclusion of quantitative information increases consistency of PET scan interpretations for early detection of cerebral amyloid-ß plaque accumulation.

A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization.

BACKGROUND: In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization. RESULTS: A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites. CONCLUSION: This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014.

Correlates of Preincarceration Health Care Use Among Women and Men in Jail.

Although women and men in jails bear a burden of health problems, little is known about factors associated with their health care use. We conducted a cross-sectional survey of preincarceration health care use with 596 jail inmates. Descriptive statistics and correlates of participants' health care use were assessed. A year before incarceration, 54% of participants used an emergency room, 24% were hospitalized, and 39% used primary care. Correlates of health care use included gender, health insurance status, and drug dependence. For participants without mental health problems, use was associated with living in neighborhoods where a higher percentage of residents did not complete high school. Findings suggest individual and community factors that can be targeted by reentry programs to improve health care use after jail.

Open-source, Rapid Reporting of Dementia Evaluations.

The National Institutes of Health Alzheimer's Disease Center consortium requires member institutions to build and maintain a longitudinally characterized cohort with a uniform standard data set. Increasingly, centers are employing electronic data capture to acquire data at annual evaluations. In this paper, the University of Kansas Alzheimer's Disease Center reports on an open-source system of electronic data collection and reporting to improve efficiency. This Center capitalizes on the speed, flexibility and accessibility of the system to enhance the evaluation process while rapidly transferring data to the National Alzheimer's Coordinating Center. This framework holds promise for other consortia that regularly use and manage large, standardized datasets.