Utility of human epididymis protein 4 in the differential diagnosis of ascites.

BACKGROUND AND AIMS: Human epididymal protein 4 (HE4) may be a useful tool in the differential diagnosis of malignant ascites. The aim of this study was to evaluate the diagnostic utility of HE4 for detecting malignant ascites, taking into account the possible false positives identified with adenosine deaminase (ADA), C-reactive protein (CRP), % polynuclear cells (%PMN) and glomerular filtration rate (eGFR). METHODS: Concentrations of HE4, ADA, %PMN and CRP were determined in 114 samples of peritoneal fluid and creatinine in serum in order to calculate eGFR. RESULTS: Concentrations of HE4 presented significant differences (P = 0.028) in benign [median (interquartile range)] [582(372)] pmol/L) and malignant ascites ([8241(367)] pmol/L. Sensitivity was 21.2% and specificity 100%. Significant differences were also observed for HE4 between tumors of gynecological origin ([3165(8769)] pmol/L) and others ([665(663)] pmol/L), with a sensitivity of 67% and a specificity of 100%. Classifying according to possible false positives (ADA > 45U/L, CRP > 50 mg/L, %PMN > 90 and eGFR < 30 mL/min/1.73 m2) at maximum specificity, a sensitivity of 33.3% was obtained for HE4, with a cut-off point of 2660 pmol/L. Without possible false positives (ADA < 45U/L, CRP < 50 mg/L, %PMN < 90 and eGFR ≥ 30 mL/min/1.73 m2), a sensitivity of 37.7% was obtained at 100% specificity for a cut-off point of 1041 pmol/L. Applying these criteria to the entire group, a sensitivity of 36.4% was obtained at maximum specificity. CONCLUSIONS: HE4 allows the identification of malignant ascites with moderate sensitivity at maximum specificity. HE4 levels can differentiate between tumors of gynecological origin and others. Classification according to possible false positives increases sensitivity without losing specificity.

Pandemic Crisis: Simulation Contingency Plans.

BACKGROUND: The COVID-19 pandemic has disrupted the typical delivery of nursing education. Multifactorial issues related to the pandemic and clinical placements have forced nurse educators to employ innovative strategies for content delivery. METHODS: This article is an accounting of a simulation team response to the move to all remote or virtual simulated learning experiences over a two-week period and lessons learned on how to move forward with simulated learning contingency plans. RESULTS: Learning outcomes were achieved via the delivery of online commercial and faculty made experiences to simulate clinical practice. Simple and easy to use guides assisted both students and faculty for a positive experience. CONCLUSION: Creating a detailed formal contingency plan for emergencies is essential for nursing programs. Additionally, the pandemic highlighted the importance of continuing faculty development and education in online, virtual, and simulation pedagogy. Finally, it is recommended that schools of nursing implement formal policies for replacement of clinical hours with simulation.

Previous SARS-CoV-2 Infection Increases B.1.1.7 Cross-Neutralization by Vaccinated Individuals.

With the spread of new variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is a need to assess the protection conferred by both previous infections and current vaccination. Here we tested the neutralizing activity of infected and/or vaccinated individuals against pseudoviruses expressing the spike of the original SARS-CoV-2 isolate Wuhan-Hu-1 (WH1), the D614G mutant and the B.1.1.7 variant. Our data show that parameters of natural infection (time from infection and nature of the infecting variant) determined cross-neutralization. Uninfected vaccinees showed a small reduction in neutralization against the B.1.1.7 variant compared to both the WH1 strain and the D614G mutant. Interestingly, upon vaccination, previously infected individuals developed more robust neutralizing responses against B.1.1.7, suggesting that vaccines can boost the neutralization breadth conferred by natural infection.

Using virtual simulation and electronic health records to assess student nurses' documentation and critical thinking skills.

INTRODUCTION: Electronic health records have become a standard documentation platform to house patient information in most US hospitals. To improve documentation, providers suggest establishing electronic health record user education at the classroom level so students can interact with patient data early. The purpose of this study was to assess student nurses' clinical documentation and critical thinking skills using virtual patients and a simulated electronic health record system. METHODS: Eighty-four undergraduate nursing students completed assessments on four assigned virtual patients and entered their findings into a simulated electronic health record system. Benner's five stage novice to expert theory was used to evaluate performance of six assessment items. RESULTS: Significant differences (p = 0.046) were seen in median scores between the first and second assignments, and between the second and fourth assignments (p = 0.021) with minimal improvements from one assignment to the next. DISCUSSION: Data entered in the electronic health record showed that students started at an advance beginner's level and moved to be proficient in documenting basic patient information using critical thinking skills by the end of the first semester. CONCLUSION: It is important to expose students to electronic health record systems before entering the workforce or while training in a hospital setting to enhance readiness for clinical practice with electronic documentation and critical thinking skills.

Patient beliefs and behaviors about genomic risk for type 2 diabetes: implications for prevention.

Type 2 diabetes is a major health burden in the United States, and population trends suggest this burden will increase. High interest in, and increased availability of, testing for genetic risk of type 2 diabetes presents a new opportunity for reducing type 2 diabetes risk for many patients; however, to date, there is little evidence that genetic testing positively affects type 2 diabetes prevention. Genetic information may not fit patients' illness representations, which may reduce the chances of risk-reducing behavior changes. The present study aimed to examine illness representations in a clinical sample who are at risk for type 2 diabetes and interested in genetic testing. The authors used the Common Sense Model to analyze survey responses of 409 patients with type 2 diabetes risk factors. Patients were interested in genetic testing for type 2 diabetes risk and believed in its importance. Most patients believed that genetic factors are important to developing type 2 diabetes (67%), that diet and exercise are effective in preventing type 2 diabetes (95%), and that lifestyle changes are more effective than drugs (86%). Belief in genetic causality was not related to poorer self-reported health behaviors. These results suggest that patients' interest in genetic testing for type 2 diabetes might produce a teachable moment that clinicians can use to counsel behavior change.

The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes.

BACKGROUND: Cardiovascular disease (CVD) and diabetes account for one-third of the mortality difference between African American and white patients. We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes. METHODS: We randomized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention. The 12-month intervention provided monthly self-management support and quarterly medication management facilitation. Coprimary outcomes were changes in systolic blood pressure (SBP), hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) over 12 months. We estimated between-intervention group differences over time using linear mixed-effects models. The secondary outcome was self-reported medication adherence. RESULTS: The sample was 72% female; 49% had low health literacy, and 37% had annual income <$10,000. Model-based estimates for mean baseline SBP, HbA1c, and LDL-C were 136.8 mm Hg (95% CI 135.0-138.6), 8.0% (95% CI 7.8-8.2), and 99.1 mg/dL (95% CI 94.7-103.5), respectively. Intervention patients received 9.9 (SD 3.0) intervention calls on average. Primary providers replied to 76% of nurse medication management facilitation contacts, 18% of these resulted in medication changes. There were no between-group differences over time for SBP (P = .11), HbA1c (P = .66), or LDL-C (P = .79). Intervention patients were more likely than those receiving usual care to report improved medication adherence (odds ratio 4.4, 95% CI 1.8-10.6, P = .0008), but adherent patients did not exhibit relative improvement in primary outcomes. CONCLUSIONS: This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes. Further research is needed to determine how to maximally impact CVD risk factors in African American patients.

Emergence of OXA-48-producing Klebsiella pneumoniae and the novel carbapenemases OXA-244 and OXA-245 in Spain.

OBJECTIVES: To describe the molecular and population-level characterization of a selected group of OXA-48-like-producing Klebsiella pneumoniae isolates collected in Spain between January 2011 and May 2012. METHODS: During the study period, 151 OXA-48-like-producing K. pneumoniae isolates were collected from 10 hospitals in six different Spanish regions. From these, a representative sample of 21 isolates that caused hospital outbreaks and single infections was selected for further in-depth analysis. Molecular epidemiology was investigated using PFGE and multilocus sequence typing (MLST). Resistance genes were characterized by PCR and sequencing. Plasmids carrying bla(OXA-48-like) were studied by PFGE with S1 nuclease digestion. RESULTS: All 21 isolates had ertapenem MICs ≥ 1 mg/L, but 47.6% remained susceptible to imipenem and meropenem; bla(OXA-48) was identified in 19 isolates (90.5%) and the novel bla(OXA-244) and bla(OXA-245) genes were detected in 1 isolate each. With one exception, all isolates that contained bla(OXA-48-like) also contained bla(CTX-M-15). PFGE typing revealed six clusters comprising isolates that belonged to MLST types ST11, ST16, ST392, ST405, ST437 and ST663, respectively. Two main clusters were identified: PFGE cluster 1 (12 isolates, belonging either to ST405 or ST663, from seven hospitals), and PFGE cluster 2 (4 ST16 isolates from two hospitals). Six of seven donor isolates conjugated successfully; bla(OXA-48-like) (but not bla(CTX-M-15)) was carried on ≈ 60 kb Inc L/M plasmids. CONCLUSIONS: Multidrug-resistant K. pneumoniae producing OXA-48-like carbapenemase are emerging as important pathogens in Spain due to intra- and inter-hospital, clonal and non-clonal dissemination.

Asymptomatic bacteriuria in preadolescent girls.

BACKGROUND: The detection of asymptomatic bacteriuria in preadolescent girls may be important due to its effects on subsequent pregnancies. OBJECTIVE: To describe the prevalence of asymptomatic bacteriuria in preadolescent girls and the value of the nitrite test for screening. MATERIAL AND METHODS: Cross-sectional study in girls aged 9 to 13 years. Bacteriuria was defined as the growth of > 100,000 CFU/mL in 2 consecutive urine specimens. RESULTS: Three hundred and twenty seven girls were included. Asymptomatic bacteriuria was found in 7 girls, so the prevalence was 2.1% (95% CI, 1 to 4.4%). Escherichia coli was the isolated agent in all the cases. Focused interrogatory found history of urinary symptoms in 6 girls. The utility values of the nitrite test were: sensitivity, 1; specificity, 0.9; positive likelihood ratio, 10; and negative predictive value, 1. CONCLUSIONS: The prevalence of asymptomatic bacteriuria in preadolescent girls in this Mexican study is similar to the one reported internationally; it is reasonable to consider its early detection to avoid its effects on future pregnancies. Nitrite test seems to be good for screening.

Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

BACKGROUND: Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT) assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. METHODS/DESIGN: Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA) for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm), or the SRA alone ("SRA" arm). Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm). Risk counseling is provided by clinic staff (not study staff external to the clinic). Fasting plasma glucose, insulin levels, body mass index (BMI), and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. DISCUSSION: The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk information in a primary care setting can help improve patients' clinical outcomes, risk perceptions, and/or their engagement in healthy behavior change. In addition, study design features such as the use of existing clinic personnel for risk counseling could inform the future development and implementation of care models for the use of individual genetic risk information in primary care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00849563.

Quality indicators and specifications for key analytical-extranalytical processes in the clinical laboratory. Five years' experience using the Six Sigma concept.

BACKGROUND: The results of 5 years of experience (2004-2008) with process-based quality management using quality indicators for key laboratory processes (analytic and extra-analytic) in a group of clinical laboratories affiliated with the Catalan Health Institute are presented. Our purpose was to analyze the evolution of the indicators, identify processes that require corrective measures, and obtain specifications that are more robust than the preliminary ones proposed in a previous study by the same group. METHODS: The yearly average was recorded for each indicator in each laboratory, the yearly interlaboratory median was calculated, and the changes occurring were studied to determine their continuity in the 5-year period. For each indicator, the average of the yearly medians was calculated and the results transformed to the Six Sigma scale to estimate the degree of control over the related process. It was suggested to establish the yearly interlaboratory median as the desirable specification for each indicator. RESULTS: The medians for most indicators were stable during the period studied. Thus, the specifications proposed in the first study were considered robust in these cases. The Six Sigma statistic provided added value in this study because it enabled detection of processes that should be improved, in which case the specifications proposed were considered provisional despite their stability. After identifying processes that have the greatest impact on patient safety, the group set a specification of 0%, regardless of the actual specification obtained, although the members are conscious of the difficulty in attaining this level of quality. Certain processes that are in a period of change obtained specifications that are considered in a phase of consolidation. CONCLUSIONS: The results for indicators related with sample collection indicate that the process is stable and well controlled. However, based on the results for Hemolyzed serum sample, the group saw the need for installing centrifuges in all phlebotomy centers and established a recommendation to unify the system for measuring hemolysis. The indicator External control exceeds acceptance limit clearly highlighted the need to rigorously monitor the analytic phase of the clinical laboratory. The values obtained for the indicator Reports from referred tests exceed delivery time show that there is considerable deviation regarding the expected report delivery time, whereas for in-house laboratory reports, delivery time is satisfactory.

Indicators and quality specifications for strategic and support processes related to the clinical laboratory: four years' experience.

BACKGROUND: Quality specifications for indicators of the key analytic processes have been defined by international consensus. However, only preliminary specifications for laboratory-related strategic and support processes have been developed. The present study attempts to increase the robustness of the preliminary proposed specifications. METHODS: Recovering records and incidences occurred over a 4-year follow-up period, for 12 indicators, used in all laboratories from this group regarding strategic and support processes. RESULTS AND CONCLUSIONS: The results obtained indicate that it is better to establish an interval rather than a fixed value for the majority of indicators. Longer studies are needed to properly assess some quality specifications, and data recording system must be standardized in others. Additional, multicenter studies are needed to establish more robust specifications and determine the state of the art of laboratories in other settings.

The Cholesterol, Hypertension, and Glucose Education (CHANGE) study for African Americans with diabetes: study design and methodology.

BACKGROUND: Cardiovascular disease (CVD) and diabetes account for over one third of the mortality difference between African Americans and white patients. The increased CVD risk in African Americans is due in large part to the clustering of multiple CVD risk factors. OBJECTIVES: The current study is aimed at improving CVD outcomes in African-American adults with diabetes by addressing the modifiable risk factors of systolic blood pressure , glycosylated hemoglobin, and low-density lipoprotein cholesterol. METHODS: A sample of African American patients with diabetes (N = 400) will receive written education material at baseline and be randomized to one of 2 arms: (1) usual primary care or (2) nurse-administered disease-management intervention combining patient self-management support and provider medication management. The nurse administered intervention is delivered monthly over the telephone. The nurses also interacts with the primary care providers at 3, 6, and 9 months to provide concise patient updates and facilitate changes in medical management. All patients are followed for 12 months after enrollment. The primary outcomes are change in glycosylated hemoglobin, systolic blood pressure, and low-density lipoprotein cholesterol over 12-months. Secondary outcomes include change in overall cardiovascular risk, aspirin use, and health behaviors. CONCLUSION: Given the continued racial disparities in CVD, the proposed study could result in significant contributions to cardiovascular risk reduction in African-American patients.