Detection of SARS-CoV-2 IgG Targeting Nucleocapsid or Spike Protein by Four High-Throughput Immunoassays Authorized for Emergency Use.

A total of 1,200 serum samples that were tested for SARS-CoV-2 IgG antibody using the Abbott Architect immunoassay targeting the nucleocapsid protein were run in 3 SARS-CoV-2 IgG immunoassays targeting spike proteins (DiaSorin Liaison, Ortho Vitros, and Euroimmun). Consensus-positive and consensus-negative interpretations were defined as qualitative agreement in at least 3 of the 4 assays. Agreement of the 4 individual assays with a consensus-negative interpretation (n = 610) ranged from 96.7% to 100%, and agreement with a consensus-positive interpretation (n = 584) ranged from 94.3% to 100%. Laboratory-developed inhibition assays were utilized to evaluate 49 consensus-negative samples that were positive in only one assay; true-positive reactivity was confirmed in only 2 of these 49 (4%) samples. These findings demonstrate very high levels of agreement among 4 SARS-CoV-2 IgG assays authorized for emergency use, regardless of antigen target or assay format. Although false-positive reactivity was identified, its occurrence was rare (no more than 1.7% of samples for a given assay).

Personality, environmental stressors, and diarrhea in Rhesus macaques: An interactionist perspective.

Previous research has repeatedly shown both personality and psychological stress to predict gastrointestinal disorders and chronic diarrhea in humans. The goal of the present research was to evaluate the role of personality, as well as psychological stressors (i.e., housing relocations and rearing environment), in predicting chronic diarrhea in captive Rhesus macaques, with particular attention to how personality regulated the impact of such stressors. Subjects were 1,930 R. macaques at the California National Primate Research Center reared in a variety of environments. All subjects took part in an extensive personality evaluation at approximately 90-120 days of age. Data were analyzed using generalized linear models to determine how personality, rearing condition, housing relocations, and personality by environment interactions, predicted both diarrhea risk (an animal's risk for having diarrhea at least once) and chronic diarrhea (how many repeated bouts of diarrhea an animal had after their initial bout). Much like the human literature, we found that certain personality types (i.e., nervous, gentle, vigilant, and not confident) were more likely to have chronic diarrhea, and that certain stressful environments (i.e., repeated housing relocations) increased diarrhea risk. We further found multiple interactions between personality and environment, supporting the "interactionist" perspective on personality and health. We conclude that while certain stressful environments increase risk for chronic diarrhea, the relative impact of these stressors is highly dependent on an animal's personality.

Prediction of Future Medical Costs by Modifiable Measures of Health.

Introduction: Strategies to mitigate rising health-care costs are a priority for patients, employers, and health insurers. Yet gaps currently exist in whether health risk assessment can forecast medical claims costs. This study examined the ability of a health quotient (HQ) based on modifiable risk factors, age, sex, and chronic conditions to predict future medical claims spending. Methods: The study included 18,695 employees and adult dependents who participated in health assessments and were enrolled in an employer-sponsored health plan. Linear mixed effect models stratified by chronic conditions and adjusted for age and sex were utilized to evaluate the relationship between the health quotient (score of 0-100) and future medical claims spending. Results: Lower baseline health quotient was associated with higher medical claims cost over 2 years of follow up. For participants with chronic condition(s), costs were $3628 higher for those with a low health quotient (<73; N = 2673) compared to those with high health quotient (>85; N = 1045), after adjustment for age and sex (P value = 0.004). Each one-unit increase in health quotient was associated with a decrease of $154 (95% CI: 87.4, 220.3) in average yearly medical claims costs during follow up. Discussion: This study used a large employee population with 2 years of follow-up data, which provides insights that are applicable to other large employers. Results of this analysis contribute to our ability to predict health-care costs using modifiable aspects of health, objective laboratory testing and chronic condition status.

Prenatal cell-free DNA screening for fetal aneuploidy in pregnant women at average or high risk: Results from a large US clinical laboratory.

BACKGROUND: We evaluated the performance of a cell-free DNA (cfDNA) prenatal screening assay for trisomies 21, 18, and 13, and sex chromosome aneuploidies (SCAs) among a population of pregnant women that included both those at average and high risk. METHODS: Specimen collection, cfDNA extraction, massively parallel sequencing, and bioinformatics analysis were conducted per laboratory protocol. Assay results, concordance with pregnancy outcomes, and performance characteristics were evaluated. RESULTS: A total 75,658 specimens from 72,176 individual pregnant women were received. Technical reasons accounted for 288 (0.4% of all received samples) tests not performed. In the final analysis cohort (N = 69,794), 13% of pregnancies were considered at average risk and 87% at high risk. Mean gestational age at specimen collection was 15.1 weeks. Of the 69,794 unique pregnancies, 1,359 (1.9%) had positive test results. Among the results with confirmed outcomes, PPV for trisomies 21, 18, and 13 was 98.1%, 88.2%, and 59.3%, respectively; the PPV was 69.0% for SCAs and 75.0% for microdeletions. Overall, PPV was 87.2%, sensitivity was 97.9%, and specificity was 99.9%. CONCLUSION: This cfDNA prenatal screening assay provides highly accurate discrimination between affected and unaffected pregnancies among a population of pregnant women at average and high risk for fetal genetic abnormalities.

Development of a tailored survey to evaluate a patient-centered initiative.

OBJECTIVES: Patient-centered care initiatives have proliferated, but assessing their effectiveness requires measures tailored to their likely effects. In this article, we describe the development and pilot testing of patient surveys used to assess change in patients' cancer care experiences over time in response to a patient-centered care initiative. STUDY DESIGN: Prospective case series. METHODS: Domains of patient-centered care were informed by the goals of the initiative and a review of existing tools. Items were selected and modified from 6 domains of validated or semivalidated instruments. Items were piloted with patients with cancer in waiting room settings to further assess the relevance and clarity of items, whether important concepts were missing, and acceptability regarding place and timing of the surveys and to estimate baseline top box scores (percentage of patients scoring an item the highest quality level) to minimize likely ceiling effects. The instrument was then administered to a consecutive sample of Stanford Cancer Center patients. Baseline item responses, Cronbach's alpha, and response bias were estimated. RESULTS: Items were modified based on patient feedback, top box scores, and reassessment of the domains. Over 6 months, 11,273 patients were surveyed, with a 49.7% response rate. Baseline top box scores ranged from 41.7% to 75.0% for any given item. Reliability and internal consistency were high for all domains (Cronbach's alpha ≥0.80) except for the access domain. CONCLUSIONS: We developed reliable instruments to evaluate the essential elements of a patient-centered care initiative at an academic medical center, which minimized patient burden and maximized the response rate.

Factors Associated With Delayed Discharge on General Medicine Service at an Academic Medical Center.

Lack of collaboration between care teams and patients/families has been associated with delayed discharge from the hospital. In this study, we determine whether patients' awareness of the estimated date of discharge (EDD) was associated with a decrease in delayed discharge, and determine the factors associated with a delayed discharge. A total of 221 patients admitted to the General Medicine service between July and September 2014 were included in the study. Estimated date of discharge was identified within 36 hours of admission. The bedside nurse communicated this EDD to the patient/family. Patients were interviewed to identify whether they were aware of their EDD. Bedside nurses were interviewed to identify barriers to discharge. In our study, 49.8% of the patients had a delayed discharge. Patients who were aware of their EDD were less likely to have a delayed discharge (odds ratio [OR], 0.3 [95% confidence interval (CI), 0.1-0.6], p < .001). Patients who were discharged on Saturday or Sunday (OR, 4.8 [95% CI, 1.7-14.6], p < .001) and patients who were waiting for physicians' consult (OR, 4.5 [95% CI, 1.6-14.4], p = .007) were more likely to have a delayed discharge. Early identification of the EDD and communicating it with the care team and the patient/family, mobilizing resources for safe weekend discharges, and creating efficient process for consultations might decrease delayed discharges.

Inpatient Hospital Factors and Resident Time With Patients and Families.

OBJECTIVES: To define hospital factors associated with proportion of time spent by pediatric residents in direct patient care. METHODS: We assessed 6222 hours of time-motion observations from a representative sample of 483 pediatric-resident physicians delivering inpatient care across 9 pediatric institutions. The primary outcome was percentage of direct patient care time (DPCT) during a single observation session (710 sessions). We used one-way analysis of variance to assess a significant difference in the mean percentage of DPCT between hospitals. We used the intraclass correlation coefficient analysis to determine within- versus between-hospital variations. We compared hospital characteristics of observation sessions with ≥12% DPCT to characteristics of sessions with <12% DPCT (12% is the DPCT in recent resident trainee time-motion studies). We conducted mixed-effects regression analysis to allow for clustering of sessions within hospitals and accounted for correlation of responses across hospital. RESULTS: Mean proportion of physician DPCT was 13.2% (SD = 8.6; range, 0.2%-49.5%). DPCT was significantly different between hospitals (P < .001). The intraclass correlation coefficient was 0.25, indicating more within-hospital than between-hospital variation. Observation sessions with ≥12% DPCT were more likely to occur at hospitals with Magnet designation (odds ratio [OR] = 3.45, P = .006), lower medical complexity (OR = 2.57, P = .04), and higher patient-to-trainee ratios (OR = 2.48, P = .05). CONCLUSIONS: On average, trainees spend <8 minutes per hour in DPCT. Variation exists in DPCT between hospitals. A less complex case mix, increased patient volume, and Magnet designation were independently associated with increased DPCT.

Using Lean Management to Reduce Emergency Department Length of Stay for Medicine Admissions.

BACKGROUND: The practice of boarding admitted patients in the emergency department (ED) carries negative operational, clinical, and patient satisfaction consequences. Lean tools have been used to improve ED workflow. Interventions focused on reducing ED length of stay (LOS) for admitted patients are less explored. OBJECTIVE: To evaluate a Lean-based initiative to reduce ED LOS for medicine admissions. DESIGN, SETTING, PATIENTS: Prospective quality improvement initiative performed at a single university-affiliated Department of Veterans Affairs (VA) medical center from February 2013 to February 2016. INTERVENTION: We performed a Lean-based multidisciplinary initiative beginning with a rapid process improvement workshop to evaluate current processes, identify root causes of delays, and develop countermeasures. Frontline staff developed standard work for each phase of the ED stay. Units developed a daily management system to reinforce, evaluate, and refine standard work. MEASUREMENTS: The primary outcome was the change in ED LOS for medicine admissions pre- and postintervention. ED LOS at the intervention site was compared with other similar VA facilities as controls over the same time period using a difference-in-differences approach. RESULTS: ED LOS for medicine admissions reduced 26.4%, from 8.7 to 6.4 hours. Difference-in-differences analysis showed that ED LOS for combined medicine and surgical admissions decreased from 6.7 to 6.0 hours (-0.7 hours, P = .003) at the intervention site compared with no change (5.6 hours, P = .2) at the control sites. CONCLUSIONS: We utilized Lean management to significantly reduce ED LOS for medicine admissions. Specifically, the development and management of standard work were key to sustaining these results.

Electronic Release of Pathology and Radiology Results to Patients: Opinions and Experiences of Oncologists.

PURPOSE: There is an emerging standard to provide patients rapid electronic access to elements of their medical records. Although surveys of patients generally support it, this practice is controversial among oncologists, because few empiric data are available for scenarios of potentially life-threatening conditions like cancer. We report the views of oncologists about patient electronic access to radiology and pathology results that could potentially indicate disease progression. METHODS: Four months before oncologists were surveyed, final results of radiology/pathology reports were routinely made available to patients online through a secure portal after a 7-day, hold to provide clinicians time to review and communicate results with the patients. Mixed methods were used to assess physician attitudes and experiences toward this change. RESULTS: One hundred twenty-nine oncologists were surveyed, and 82 (64%) responded. A small majority (54%) responded that the release of reports was somewhat or very beneficial for patients who received normal radiology/pathology results before discussion with a physician, but 87% said it was somewhat or very harmful for patients to receive abnormal results before discussion. Forty-nine percent reported that release of reports had a somewhat or very negative impact on communication with their patients. CONCLUSION: Almost half of oncologists reported that sharing digital radiology and pathology records had a negative impact on their communication with patients. Patient surveys in similar cancer populations would complement the physician perspective. Efforts are needed to improve consensus among oncologists and patients on how to best communicate such results in a timely fashion.

AKI in hospitalized children: epidemiology and clinical associations in a national cohort.

BACKGROUND AND OBJECTIVES: Although AKI is common among hospitalized children, comprehensive epidemiologic data are lacking. This study characterizes pediatric AKI across the United States and identifies AKI risk factors using high-content/high-throughput analytic techniques. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: For the cross-sectional analysis of the 2009 Kids Inpatient Database, AKI events were identified using International Classification of Diseases, Ninth Revision, Clinical Modification codes. Demographics, incident rates, and outcome data were analyzed and reported for the entire AKI cohort as well as AKI subsets. Statistical learning methods were applied to the highly imbalanced dataset to derive AKI-related risk factors. RESULTS: Of 2,644,263 children, 10,322 children developed AKI (3.9/1000 admissions). Although 19% of the AKI cohort was ≤ 1 month old, the highest incidence was seen in children 15-18 years old (6.6/1000 admissions); 49% of the AKI cohort was white, but AKI incidence was higher among African Americans (4.5 versus 3.8/1000 admissions). In-hospital mortality among patients with AKI was 15.3% but higher among children ≤ 1 month old (31.3% versus 10.1%, P<0.001) and children requiring critical care (32.8% versus 9.4%, P<0.001) or dialysis (27.1% versus 14.2%, P<0.001). Shock (odds ratio, 2.15; 95% confidence interval, 1.95 to 2.36), septicemia (odds ratio, 1.37; 95% confidence interval, 1.32 to 1.43), intubation/mechanical ventilation (odds ratio, 1.2; 95% confidence interval, 1.16 to 1.25), circulatory disease (odds ratio, 1.47; 95% confidence interval, 1.32 to 1.65), cardiac congenital anomalies (odds ratio, 1.2; 95% confidence interval, 1.13 to 1.23), and extracorporeal support (odds ratio, 2.58; 95% confidence interval, 2.04 to 3.26) were associated with AKI. CONCLUSIONS: AKI occurs in 3.9/1000 at-risk US pediatric hospitalizations. Mortality is highest among neonates and children requiring critical care or dialysis. Identified risk factors suggest that AKI occurs in association with systemic/multiorgan disease more commonly than primary renal disease.