A method for estimation of bias and variability of continuous gas monitor data: application to carbon monoxide monitor accuracy.

PubMed

Shulman, Stanley A; Smith, Jerome P

2002-01-01

A method is presented for the evaluation of the bias, variability, and accuracy of gas monitors. This method is based on using the parameters for the fitted response curves of the monitors. Thereby, variability between calibrations, between dates within each calibration period, and between different units can be evaluated at several different standard concentrations. By combining variability information with bias information, accuracy can be assessed. An example using carbon monoxide monitor data is provided. Although the most general statistical software required for these tasks is not available on a spreadsheet, when the same number of dates in a calibration period are evaluated for each monitor unit, the calculations can be done on a spreadsheet. An example of such calculations, together with the formulas needed for their implementation, is provided. In addition, the methods can be extended by use of appropriate statistical models and software to evaluate monitor trends within calibration periods, as well as consider the effects of other variables, such as humidity and temperature, on monitor variability and bias.

Monitoring software development through dynamic variables

NASA Technical Reports Server (NTRS)

Doerflinger, Carl W.; Basili, Victor R.

1983-01-01

Research conducted by the Software Engineering Laboratory (SEL) on the use of dynamic variables as a tool to monitor software development is described. Project independent measures which may be used in a management tool for monitoring software development are identified. Several FORTRAN projects with similar profiles are examined. The staff was experienced in developing these types of projects. The projects developed serve similar functions. Because these projects are similar some underlying relationships exist that are invariant between projects. These relationships, once well defined, may be used to compare the development of different projects to determine whether they are evolving the same way previous projects in this environment evolved.

Assessing data quality and the variability of source data verification auditing methods in clinical research settings.

PubMed

Houston, Lauren; Probst, Yasmine; Martin, Allison

2018-05-18

Data audits within clinical settings are extensively used as a major strategy to identify errors, monitor study operations and ensure high-quality data. However, clinical trial guidelines are non-specific in regards to recommended frequency, timing and nature of data audits. The absence of a well-defined data quality definition and method to measure error undermines the reliability of data quality assessment. This review aimed to assess the variability of source data verification (SDV) auditing methods to monitor data quality in a clinical research setting. The scientific databases MEDLINE, Scopus and Science Direct were searched for English language publications, with no date limits applied. Studies were considered if they included data from a clinical trial or clinical research setting and measured and/or reported data quality using a SDV auditing method. In total 15 publications were included. The nature and extent of SDV audit methods in the articles varied widely, depending upon the complexity of the source document, type of study, variables measured (primary or secondary), data audit proportion (3-100%) and collection frequency (6-24 months). Methods for coding, classifying and calculating error were also inconsistent. Transcription errors and inexperienced personnel were the main source of reported error. Repeated SDV audits using the same dataset demonstrated ∼40% improvement in data accuracy and completeness over time. No description was given in regards to what determines poor data quality in clinical trials. A wide range of SDV auditing methods are reported in the published literature though no uniform SDV auditing method could be determined for "best practice" in clinical trials. Published audit methodology articles are warranted for the development of a standardised SDV auditing method to monitor data quality in clinical research settings. Copyright © 2018. Published by Elsevier Inc.

Data-driven risk identification in phase III clinical trials using central statistical monitoring.

PubMed

Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

2016-02-01

Our interest lies in quality control for clinical trials, in the context of risk-based monitoring (RBM). We specifically study the use of central statistical monitoring (CSM) to support RBM. Under an RBM paradigm, we claim that CSM has a key role to play in identifying the "risks to the most critical data elements and processes" that will drive targeted oversight. In order to support this claim, we first see how to characterize the risks that may affect clinical trials. We then discuss how CSM can be understood as a tool for providing a set of data-driven key risk indicators (KRIs), which help to organize adaptive targeted monitoring. Several case studies are provided where issues in a clinical trial have been identified thanks to targeted investigation after the identification of a risk using CSM. Using CSM to build data-driven KRIs helps to identify different kinds of issues in clinical trials. This ability is directly linked with the exhaustiveness of the CSM approach and its flexibility in the definition of the risks that are searched for when identifying the KRIs. In practice, a CSM assessment of the clinical database seems essential to ensure data quality. The atypical data patterns found in some centers and variables are seen as KRIs under a RBM approach. Targeted monitoring or data management queries can be used to confirm whether the KRIs point to an actual issue or not.

Wireless plataforms for the monitoring of biomedical variables

NASA Astrophysics Data System (ADS)

Bianco, Román; Laprovitta, Agustín; Misa, Alberto; Toselli, Eduardo; Castagnola, Juan Luis

2007-11-01

The present paper aims to analyze and to compare two wireless platforms for the monitoring of biomedical variables. They must obtain the vital signals of the patients, transmit them through a radio frequency bond and centralize them for their process, storage and monitoring in real time. The implementation of this system permit us to obtain two important benefits; The patient will enjoy greater comfort during the internment, and the doctors will be able to know the state of the biomedical variables of each patient, in simultaneous form. In order to achieve the objective of this work, two communication systems for wireless transmissions data were developed and implemented. The CC1000 transceiver was used in the first system and the Bluetooth module was used in the other system.

All-Sky Monitoring of Variable Sources with Fermi GBM

NASA Technical Reports Server (NTRS)

Wilson-Hodge, Colleen A.; Cherry, Michael L.; Case, Gary L.; Camero-Arranz, Ascension; Chaplin, Vandiver; Connaughton, Valerie; Finger, Mark H.; Jenke, Pater; Rodi, James C.; Baumgartner, Wayne H.;

First Clinical Experience with Retrospective Flash Glucose Monitoring (FGM) Analysis in South Africa

PubMed Central

Distiller, Larry A.; Cranston, Iain; Mazze, Roger

2016-01-01

Background: In 2014, an innovative blinded continuous glucose monitoring system was introduced with automated ambulatory glucose profile (AGP) reporting. The clinical use and interpretation of this new technology has not previously been described. Therefore we wanted to understand its use in characterizing key factors related to glycemic control: glucose exposure, variability, and stability, and risk of hypoglycemia in clinical practice. Methods: Clinicians representing affiliated diabetes centers throughout South Africa were trained and subsequently were given flash glucose monitoring readers and 2-week glucose sensors to use at their discretion. After patient use, sensor data were collected and uploaded for AGP reporting. Results: Complete data (sensor AGP with corresponding clinical information) were obtained for 50 patients with type 1 (70%) and type 2 diabetes (30%), irrespective of therapy. Aggregated analysis of AGP data comparing patients with type 1 versus type 2 diabetes, revealed that despite similar HbA1c values between both groups (8.4 ± 2 vs 8.6 ± 1.7%, respectively), those with type 2 diabetes had lower mean glucose levels (9.2 ± 3 vs 10.3 mmol/l [166 ± 54 vs 185 mg/dl]) and lower indices of glucose variability (3.0 ± 1.5 vs 5.0 ± 1.9 mmol/l [54 ± 27 vs 90 ± 34.2 mg/dl]). This highlights key areas for future focus. Conclusions: Using AGP, the characteristics of glucose exposure, variability, stability, and hypoglycemia risk and occurrence were obtained within a short time and with minimal provider and patient input. In a survey at the time of the follow-up visit, clinicians indicated that aggregated AGP data analysis provided important new clinical information and insights. PMID:27154973

Using business intelligence to monitor clinical quality metrics.

PubMed

Resetar, Ervina; Noirot, Laura A; Reichley, Richard M; Storey, Patricia; Skiles, Ann M; Traynor, Patrick; Dunagan, W Claiborne; Bailey, Thomas C

2007-10-11

BJC HealthCare (BJC) uses a number of industry standard indicators to monitor the quality of services provided by each of its hospitals. By establishing an enterprise data warehouse as a central repository of clinical quality information, BJC is able to monitor clinical quality performance in a timely manner and improve clinical outcomes.

Reduced anticoagulation variability in patients on warfarin monitored with Fiix-prothrombin time associates with reduced thromboembolism: The Fiix-trial.

PubMed

Oskarsdóttir, Alma Rut; Gudmundsdottir, Brynja R; Indridason, Olafur S; Lund, Sigrun H; Arnar, David O; Bjornsson, Einar S; Magnusson, Magnus K; Jensdottir, Hulda M; Vidarsson, Brynjar; Francis, Charles W; Onundarson, Pall T

2017-05-01

Fiix-prothrombin time (Fiix-PT) differs from traditional PT in being affected by reduced factor (F) II or FX only. In the randomized controlled Fiix-trial, patients on warfarin monitored with Fiix-PT (Fiix-warfarin patients) had fewer thromboembolisms (TE), similar major bleeding (MB) and more stable anticoagulation than patients monitored with PT (PT-warfarin patients). In the current Fiix-trial report we analyzed how reduced anticoagulation variability during Fiix-PT monitoring was reflected in patients with TE or bleeding. Data from 1143 randomized patients was used. We analyzed the groups for anticoagulation intensity (time within target range; TTR), international normalized ratio (INR) variability (variance growth rate B 1 ; VGR) and dose adjustment frequency. We assessed how these parameters associated with clinically relevant vascular events (CRVE), ie TE or MB or clinically relevant non-MB. TTR was highest in Fiix-warfarin patients without CRVE (median 82%;IQR 72-91) and lowest in PT-warfarin patients with TE (62%;56-81). VGR was lowest in Fiix-warfarin patients without CRVE (median VGR B 1 0.17; 95% CI 0.08-0.38) and with TE (0.20;0.07-0.26) and highest in PT-warfarin patients with TE (0.50;0.27-0.90) or MB (0.59;0.07-1.36). The mean annual dose adjustment frequency was lowest in Fiix-warfarin patients with TE (mean 5.4;95% CI 3.9-7.3) and without CRVE (mean 6.0; 5.8-6.2) and highest in PT-warfarin patients with TE (14.2;12.2-16.3). Frequent dose changes predicted MB in both study arms. Compared to patients monitored with PT, high anticoagulation stability in Fiix-warfarin patients coincided with their low TE rate. Those with bleeding had high variability irrespective of monitoring method. Thus, although further improvements are needed to reduce bleeding, stabilization of anticoagulation by Fiix-PT monitoring associates with reduced TE.

Predictive probability methods for interim monitoring in clinical trials with longitudinal outcomes.

PubMed

Zhou, Ming; Tang, Qi; Lang, Lixin; Xing, Jun; Tatsuoka, Kay

2018-04-17

In clinical research and development, interim monitoring is critical for better decision-making and minimizing the risk of exposing patients to possible ineffective therapies. For interim futility or efficacy monitoring, predictive probability methods are widely adopted in practice. Those methods have been well studied for univariate variables. However, for longitudinal studies, predictive probability methods using univariate information from only completers may not be most efficient, and data from on-going subjects can be utilized to improve efficiency. On the other hand, leveraging information from on-going subjects could allow an interim analysis to be potentially conducted once a sufficient number of subjects reach an earlier time point. For longitudinal outcomes, we derive closed-form formulas for predictive probabilities, including Bayesian predictive probability, predictive power, and conditional power and also give closed-form solutions for predictive probability of success in a future trial and the predictive probability of success of the best dose. When predictive probabilities are used for interim monitoring, we study their distributions and discuss their analytical cutoff values or stopping boundaries that have desired operating characteristics. We show that predictive probabilities utilizing all longitudinal information are more efficient for interim monitoring than that using information from completers only. To illustrate their practical application for longitudinal data, we analyze 2 real data examples from clinical trials. Copyright © 2018 John Wiley & Sons, Ltd.

Perioperative Near-Infrared Spectroscopy Monitoring in Neonates With Congenital Heart Disease: Relationship of Cerebral Tissue Oxygenation Index Variability With Neurodevelopmental Outcome.

PubMed

Spaeder, Michael C; Klugman, Darren; Skurow-Todd, Kami; Glass, Penny; Jonas, Richard A; Donofrio, Mary T

2017-03-01

To evaluate the value of perioperative cerebral near-infrared spectroscopy monitoring using variability analysis in the prediction of neurodevelopmental outcomes in neonates undergoing surgery for congenital heart disease. Retrospective cohort study. Urban, academic, tertiary-care children's hospital. Neonates undergoing surgery with cardiopulmonary bypass for congenital heart disease. Perioperative monitoring of continuous cerebral tissue oxygenation index by near-infrared spectroscopy and subsequent neurodevelopmental testing at 6, 15, and 21 months of age. We developed a new measure, cerebral tissue oxygenation index variability, using the root mean of successive squared differences of averaged 1-minute cerebral tissue oxygenation index values for both the intraoperative and first 24-hours postoperative phases of monitoring. There were 62 neonates who underwent cerebral tissue oxygenation index monitoring during surgery for congenital heart disease and 44 underwent subsequent neurodevelopmental testing (12 did not survive until testing and six were lost to follow-up). Among the 44 monitored patients who underwent neurodevelopmental testing, 20 (45%) had abnormal neurodevelopmental indices. Patients with abnormal neurodevelopmental indices had lower postoperative cerebral tissue oxygenation index variability when compared with patients with normal indices (p = 0.01). Adjusting for class of congenital heart disease and duration of deep hypothermic circulatory arrest, lower postoperative cerebral tissue oxygenation index variability was associated with poor neurodevelopmental outcome (p = 0.02). We found reduced postoperative cerebral tissue oxygenation index variability in neonatal survivors of congenital heart disease surgery with poor neurodevelopmental outcomes. We hypothesize that reduced cerebral tissue oxygenation index variability may be a surrogate for impaired cerebral metabolic autoregulation in the immediate postoperative period. Further research is

Clinical Impact of Accurate Point-of-Care Glucose Monitoring for Tight Glycemic Control in Severely Burned Children.

PubMed

Tran, Nam K; Godwin, Zachary R; Steele, Amanda N; Wolf, Steven E; Palmieri, Tina L

2016-09-01

The goal of this study was to retrospectively evaluate the clinical impact of an accurate autocorrecting blood glucose monitoring system in children with severe burns. Blood glucose monitoring system accuracy is essential for providing appropriate intensive insulin therapy and achieving tight glycemic control in critically ill patients. Unfortunately, few comparison studies have been performed to evaluate the clinical impact of accurate blood glucose monitoring system monitoring in the high-risk pediatric burn population. Retrospective analysis of an electronic health record system. Pediatric burn ICU at an academic medical center. Children (aged < 18 yr) with severe burns (≥ 20% total body surface area) receiving intensive insulin therapy guided by either a noncorrecting (blood glucose monitoring system-1) or an autocorrecting blood glucose monitoring system (blood glucose monitoring system-2). Patient demographics, insulin rates, and blood glucose monitoring system measurements were collected. The frequency of hypoglycemia and glycemic variability was compared between the two blood glucose monitoring system groups. A total of 122 patient charts from 2001 to 2014 were reviewed. Sixty-three patients received intensive insulin therapy using blood glucose monitoring system-1 and 59 via blood glucose monitoring system-2. Patient demographics were similar between the two groups. Mean insulin infusion rates (5.1 ± 3.8 U/hr; n = 535 paired measurements vs 2.4 ± 1.3 U/hr; n = 511 paired measurements; p < 0.001), glycemic variability, and frequency of hypoglycemic events (90 vs 12; p < 0.001) were significantly higher in blood glucose monitoring system-1-treated patients. Compared with laboratory measurements, blood glucose monitoring system-2 yielded the most accurate results (mean ± SD bias: -1.7 ± 6.9 mg/dL [-0.09 ± 0.4 mmol/L] vs 7.4 ± 13.5 mg/dL [0.4 ± 0.7 mmol/L]). Blood glucose monitoring system-2 patients achieve glycemic

Impact of Remote Monitoring on Clinical Outcomes.

PubMed

Varma, Niraj; Ricci, Renato Pietro

2015-12-01

Follow-up of patients with cardiac implantable electronic devices is challenging due to both their increasing volume and technical complexity coupled to increasing clinical complexity of recipient patients. Remote monitoring (RM) offers an opportunity to resolve some of these difficulties by improving clinic efficiencies and providing a mechanism for device monitoring and patient management. Several recent randomized clinical trials and registries have demonstrated that RM may reduce in-hospital visit numbers, time required for patient follow-up, physician and nurse time, and hospital and social costs. Furthermore, patient retention and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory with automatic alerts allows early detection of device malfunctions and of events, such as atrial fibrillation, ventricular arrhythmias, and heart failure suitable for clinical intervention. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. New organizational models promote significant efficiencies regarding physician and nursing time. Data management techniques are under development. Despite these demonstrable advantages of RM, adoption still remains modest, even in health care systems incentivized to use this follow-up method. © 2015 Wiley Periodicals, Inc.

Quantification of Peptides from Immunoglobulin Constant and Variable Regions by Liquid Chromatography-Multiple Reaction Monitoring Mass Spectrometry for Assessment of Multiple Myeloma Patients

PubMed Central

Remily-Wood, Elizabeth R.; Benson, Kaaron; Baz, Rachid C.; Chen, Y. Ann; Hussein, Mohamad; Hartley-Brown, Monique A.; Sprung, Robert W.; Perez, Brianna; Liu, Richard Z.; Yoder, Sean; Teer, Jamie; Eschrich, Steven A.; Koomen, John M.

2014-01-01

Purpose Quantitative mass spectrometry assays for immunoglobulins (Igs) are compared with existing clinical methods in samples from patients with plasma cell dyscrasias, e.g. multiple myeloma. Experimental design Using LC-MS/MS data, Ig constant region peptides and transitions were selected for liquid chromatography-multiple reaction monitoring mass spectrometry (LC-MRM). Quantitative assays were used to assess Igs in serum from 83 patients. Results LC-MRM assays quantify serum levels of Igs and their isoforms (IgG1–4, IgA1–2, IgM, IgD, and IgE, as well as kappa(κ) and lambda(λ) light chains). LC-MRM quantification has been applied to single samples from a patient cohort and a longitudinal study of an IgE patient undergoing treatment, to enable comparison with existing clinical methods. Proof-of-concept data for defining and monitoring variable region peptides are provided using the H929 multiple myeloma cell line and two MM patients. Conclusions and Clinical Relevance LC-MRM assays targeting constant region peptides determine the type and isoform of the involved immunoglobulin and quantify its expression; the LC-MRM approach has improved sensitivity compared with the current clinical method, but slightly higher interassay variability. Detection of variable region peptides is a promising way to improve Ig quantification, which could produce a dramatic increase in sensitivity over existing methods, and could further complement current clinical techniques. PMID:24723328

Vascular Glucose Sensor Symposium: Continuous Glucose Monitoring Systems (CGMS) for Hospitalized and Ambulatory Patients at Risk for Hyperglycemia, Hypoglycemia, and Glycemic Variability.

PubMed

Joseph, Jeffrey I; Torjman, Marc C; Strasma, Paul J

2015-07-01

Hyperglycemia, hypoglycemia, and glycemic variability have been associated with increased morbidity, mortality, length of stay, and cost in a variety of critical care and non-critical care patient populations in the hospital. The results from prospective randomized clinical trials designed to determine the risks and benefits of intensive insulin therapy and tight glycemic control have been confusing; and at times conflicting. The limitations of point-of-care blood glucose (BG) monitoring in the hospital highlight the great clinical need for an automated real-time continuous glucose monitoring system (CGMS) that can accurately measure the concentration of glucose every few minutes. Automation and standardization of the glucose measurement process have the potential to significantly improve BG control, clinical outcome, safety and cost. © 2015 Diabetes Technology Society.

Monitoring D-Region Variability from Lightning Measurements

NASA Technical Reports Server (NTRS)

Simoes, Fernando; Berthelier, Jean-Jacques; Pfaff, Robert; Bilitza, Dieter; Klenzing, Jeffery

2011-01-01

In situ measurements of ionospheric D-region characteristics are somewhat scarce and rely mostly on sounding rockets. Remote sensing techniques employing Very Low Frequency (VLF) transmitters can provide electron density estimates from subionospheric wave propagation modeling. Here we discuss how lightning waveform measurements, namely sferics and tweeks, can be used for monitoring the D-region variability and day-night transition, and for local electron density estimates. A brief comparison among D-region aeronomy models is also presented.

Symbolic dynamics marker of heart rate variability combined with clinical variables enhance obstructive sleep apnea screening

NASA Astrophysics Data System (ADS)

Ravelo-García, A. G.; Saavedra-Santana, P.; Juliá-Serdá, G.; Navarro-Mesa, J. L.; Navarro-Esteva, J.; Álvarez-López, X.; Gapelyuk, A.; Penzel, T.; Wessel, N.

2014-06-01

Many sleep centres try to perform a reduced portable test in order to decrease the number of overnight polysomnographies that are expensive, time-consuming, and disturbing. With some limitations, heart rate variability (HRV) has been useful in this task. The aim of this investigation was to evaluate if inclusion of symbolic dynamics variables to a logistic regression model integrating clinical and physical variables, can improve the detection of subjects for further polysomnographies. To our knowledge, this is the first contribution that innovates in that strategy. A group of 133 patients has been referred to the sleep center for suspected sleep apnea. Clinical assessment of the patients consisted of a sleep related questionnaire and a physical examination. The clinical variables related to apnea and selected in the statistical model were age (p < 10-3), neck circumference (p < 10-3), score on a questionnaire scale intended to quantify daytime sleepiness (p < 10-3), and intensity of snoring (p < 10-3). The validation of this model demonstrated an increase in classification performance when a variable based on non-linear dynamics of HRV (p < 0.01) was used additionally to the other variables. For diagnostic rule based only on clinical and physical variables, the corresponding area under the receiver operating characteristic (ROC) curve was 0.907 (95% confidence interval (CI) = 0.848, 0.967), (sensitivity 87.10% and specificity 80%). For the model including the average of a symbolic dynamic variable, the area under the ROC curve was increased to 0.941 (95% = 0.897, 0.985), (sensitivity 88.71% and specificity 82.86%). In conclusion, symbolic dynamics, coupled with significant clinical and physical variables can help to prioritize polysomnographies in patients with a high probability of apnea. In addition, the processing of the HRV is a well established low cost and robust technique.

Development and Feasibility Testing of a Critical Care EEG Monitoring Database for Standardized Clinical Reporting and Multicenter Collaborative Research.

PubMed

Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D

2016-04-01

The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.

Monitoring disease progression with plasma creatinine in amyotrophic lateral sclerosis clinical trials

PubMed Central

van Eijk, Ruben P A; Eijkemans, Marinus J C; Ferguson, Toby A; Nikolakopoulos, Stavros; Veldink, Jan H; van den Berg, Leonard H

2018-01-01

Objectives Plasma creatinine is a predictor of survival in amyotrophic lateral sclerosis (ALS). It remains, however, to be established whether it can monitor disease progression and serve as surrogate endpoint in clinical trials. Methods We used clinical trial data from three cohorts of clinical trial participants in the LITRA, EMPOWER and PROACT studies. Longitudinal associations between functional decline, muscle strength and survival with plasma creatinine were assessed. Results were translated to trial design in terms of sample size and power. Results A total of 13 564 measurements were obtained for 1241 patients. The variability between patients in rate of decline was lower in plasma creatinine than in ALS functional rating scale–Revised (ALSFRS-R; p<0.001). The average rate of decline was faster in the ALSFRS-R, with less between-patient variability at baseline (p<0.001). Plasma creatinine had strong longitudinal correlations with the ALSFRS-R (0.43 (0.39–0.46), p<0.001), muscle strength (0.55 (0.51–0.58), p<0.001) and overall mortality (HR 0.88 (0.86–0.91, p<0.001)). Using plasma creatinine as outcome could reduce the sample size in trials by 21.5% at 18 months. For trials up to 10 months, the ALSFRS-R required a lower sample size. Conclusions Plasma creatinine is an inexpensive and easily accessible biomarker that exhibits less variability between patients with ALS over time and is predictive for the patient’s functional status, muscle strength and mortality risk. Plasma creatinine may, therefore, increase the power to detect treatment effects and could be incorporated in future ALS clinical trials as potential surrogate outcome. PMID:29084868

Alcohol- and light-induced electro-oculographic responses: variability and clinical utility.

PubMed

Marmor, Michael F; Wu, Kathy H C

2005-01-01

The alcohol-induced electro-oculographic (EOG) response has been proposed by Arden as an indicator of retinal pigment epithelial (RPE) integrity. We have evaluated the consistency of the alcohol-EOG with respect to clinical applicability and compared this response to the ISCEV-standard EOG. We recorded, in a group of normal subjects (n=29, 14 men with mean age 42+/-11 years and 15 women with mean age 36+/-13 years), the alcohol response to a single oral dose of ethanol at 160 mg/kg (as 40 proof vodka, drunk in 15 s after 12 h of fasting), followed by an ISCEV-standard EOG 90 min after alcohol administration. Blood alcohol levels were monitored at regular intervals with a breath analyzer. We found a wide range of amplitudes in both light and alcohol responses among participants, from minimal to large values. Subjects had a wide range of blood alcohol concentrations from 0.02 to 0.10%; near the time of the response peak, but there was no relationship between alcohol levels and peak/baseline ratios. In addition, there was no relationship between alcohol peak/baseline ratio and the Arden ratio. Neither the alcohol nor the light response parameters showed any relationship with age or gender. Some of the inter-individual variability in the EOG response to alcohol may reflect variable absorption of oral alcohol. The alcohol-induced EOG has too broad a range of responses to be useful clinically for the one-time evaluation of individual patients. We have similar concerns regarding clinical applications of the standard light-induced EOG.

Ambulatory blood pressure monitoring-derived short-term blood pressure variability in primary hyperparathyroidism.

PubMed

Concistrè, A; Grillo, A; La Torre, G; Carretta, R; Fabris, B; Petramala, L; Marinelli, C; Rebellato, A; Fallo, F; Letizia, C

2018-04-01

Primary hyperparathyroidism is associated with a cluster of cardiovascular manifestations, including hypertension, leading to increased cardiovascular risk. The aim of our study was to investigate the ambulatory blood pressure monitoring-derived short-term blood pressure variability in patients with primary hyperparathyroidism, in comparison with patients with essential hypertension and normotensive controls. Twenty-five patients with primary hyperparathyroidism (7 normotensive,18 hypertensive) underwent ambulatory blood pressure monitoring at diagnosis, and fifteen out of them were re-evaluated after parathyroidectomy. Short-term-blood pressure variability was derived from ambulatory blood pressure monitoring and calculated as the following: 1) Standard Deviation of 24-h, day-time and night-time-BP; 2) the average of day-time and night-time-Standard Deviation, weighted for the duration of the day and night periods (24-h "weighted" Standard Deviation of BP); 3) average real variability, i.e., the average of the absolute differences between all consecutive BP measurements. Baseline data of normotensive and essential hypertension patients were matched for age, sex, BMI and 24-h ambulatory blood pressure monitoring values with normotensive and hypertensive-primary hyperparathyroidism patients, respectively. Normotensive-primary hyperparathyroidism patients showed a 24-h weighted Standard Deviation (P < 0.01) and average real variability (P < 0.05) of systolic blood pressure higher than that of 12 normotensive controls. 24-h average real variability of systolic BP, as well as serum calcium and parathyroid hormone levels, were reduced in operated patients (P < 0.001). A positive correlation of serum calcium and parathyroid hormone with 24-h-average real variability of systolic BP was observed in the entire primary hyperparathyroidism patients group (P = 0.04, P  = 0.02; respectively). Systolic blood pressure variability is increased in normotensive

Reconfigurable wearable to monitor physiological variables and movement

NASA Astrophysics Data System (ADS)

Romero, Francisco J.; Morales, Diego P.; Castillo, Encarnación; García, Antonio; Tahmassebi, Amirhessam; Meyer-Baese, Anke

2017-05-01

This article presents a preliminary prototype of a wearable instrument for oxygen saturation and ECG monitoring. The proposed measuring system is based on the light reflection variability of a LED emission on the subject temple. Besides, the system has the capacity to incorporate electrodes to obtain ECG measurements. All measurements are stored and transmitted to a mobile device (tablet or smartphone) through a Bluetooth link.

Role of Large Clinical Datasets From Physiologic Monitors in Improving the Safety of Clinical Alarm Systems and Methodological Considerations: A Case From Philips Monitors.

PubMed

Sowan, Azizeh Khaled; Reed, Charles Calhoun; Staggers, Nancy

2016-09-30

Large datasets of the audit log of modern physiologic monitoring devices have rarely been used for predictive modeling, capturing unsafe practices, or guiding initiatives on alarm systems safety. This paper (1) describes a large clinical dataset using the audit log of the physiologic monitors, (2) discusses benefits and challenges of using the audit log in identifying the most important alarm signals and improving the safety of clinical alarm systems, and (3) provides suggestions for presenting alarm data and improving the audit log of the physiologic monitors. At a 20-bed transplant cardiac intensive care unit, alarm data recorded via the audit log of bedside monitors were retrieved from the server of the central station monitor. Benefits of the audit log are many. They include easily retrievable data at no cost, complete alarm records, easy capture of inconsistent and unsafe practices, and easy identification of bedside monitors missed from a unit change of alarm settings adjustments. Challenges in analyzing the audit log are related to the time-consuming processes of data cleaning and analysis, and limited storage and retrieval capabilities of the monitors. The audit log is a function of current capabilities of the physiologic monitoring systems, monitor's configuration, and alarm management practices by clinicians. Despite current challenges in data retrieval and analysis, large digitalized clinical datasets hold great promise in performance, safety, and quality improvement. Vendors, clinicians, researchers, and professional organizations should work closely to identify the most useful format and type of clinical data to expand medical devices' log capacity.

Multiparametric monitoring of tissue vitality in clinical situations

NASA Astrophysics Data System (ADS)

Mayevsky, Avraham; Manor, Tamar; Meilin, Sigal; Razon, Nisim; Ouknine, George E.; Ornstein, Eugene

2001-05-01

The monitoring of various tissue's physiological and biochemical parameters is one of the tools used by the clinicians to improve diagnosis capacity. As of today, the very few devices developed for real time clinical monitoring of tissue vitality are based on a single parameter measurement. Tissue energy balance could be defined as the ratio between oxygen or energy supply and demand. In order to determine the vitality of the brain, for example, it is necessary to measure at least the following 3 parameters: Energy Demand--potassium ion homeostasis; Energy Supply-- cerebral blood flow; Energy Balance--mitochondrial NADH redox state. For other tissues one can measure various energy demand processes specific to the tested organ. We have developed a unique multiparametric monitoring system tested in various experimental and clinical applications. The multiprobe assembly (MPA) consists of a fiber optic probe for measurement of tissue blood flow and mitochondrial NADH redox state, ion selective electrodes (K+, Ca2+, H+), electrodes for electrical activities (ECoG or ECG and DC potential), temperature probe and for monitoring the brain - Intra Cranial Pressure probe (ICP). The computerized monitoring system was used in the neurological intensive care unit to monitor comatose patients for a period of 24-48 hours. Also, a simplified MPA was used in the neurosurgical operating room or during organ transplantation procedure. It was found that the MPA could be used in clinical situations and that the data collected has a significant diagnosis value for the medical team.

Review and classification of variability analysis techniques with clinical applications.

PubMed

Bravi, Andrea; Longtin, André; Seely, Andrew J E

2011-10-10

Analysis of patterns of variation of time-series, termed variability analysis, represents a rapidly evolving discipline with increasing applications in different fields of science. In medicine and in particular critical care, efforts have focussed on evaluating the clinical utility of variability. However, the growth and complexity of techniques applicable to this field have made interpretation and understanding of variability more challenging. Our objective is to provide an updated review of variability analysis techniques suitable for clinical applications. We review more than 70 variability techniques, providing for each technique a brief description of the underlying theory and assumptions, together with a summary of clinical applications. We propose a revised classification for the domains of variability techniques, which include statistical, geometric, energetic, informational, and invariant. We discuss the process of calculation, often necessitating a mathematical transform of the time-series. Our aims are to summarize a broad literature, promote a shared vocabulary that would improve the exchange of ideas, and the analyses of the results between different studies. We conclude with challenges for the evolving science of variability analysis.

Review and classification of variability analysis techniques with clinical applications

PubMed Central

2011-01-01

Analysis of patterns of variation of time-series, termed variability analysis, represents a rapidly evolving discipline with increasing applications in different fields of science. In medicine and in particular critical care, efforts have focussed on evaluating the clinical utility of variability. However, the growth and complexity of techniques applicable to this field have made interpretation and understanding of variability more challenging. Our objective is to provide an updated review of variability analysis techniques suitable for clinical applications. We review more than 70 variability techniques, providing for each technique a brief description of the underlying theory and assumptions, together with a summary of clinical applications. We propose a revised classification for the domains of variability techniques, which include statistical, geometric, energetic, informational, and invariant. We discuss the process of calculation, often necessitating a mathematical transform of the time-series. Our aims are to summarize a broad literature, promote a shared vocabulary that would improve the exchange of ideas, and the analyses of the results between different studies. We conclude with challenges for the evolving science of variability analysis. PMID:21985357

The future of monitoring in clinical research - a holistic approach: linking risk-based monitoring with quality management principles.

PubMed

Ansmann, Eva B; Hecht, Arthur; Henn, Doris K; Leptien, Sabine; Stelzer, Hans Günther

2013-01-01

Since several years risk-based monitoring is the new "magic bullet" for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled.Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.

Square2 - A Web Application for Data Monitoring in Epidemiological and Clinical Studies

PubMed

Schmidt, Carsten Oliver; Krabbe, Christine; Schössow, Janka; Albers, Martin; Radke, Dörte; Henke, Jörg

2017-01-01

Valid scientific inferences from epidemiological and clinical studies require high data quality. Data generating departments therefore aim to detect data irregularities as early as possible in order to guide quality management processes. In addition, after the completion of data collections the obtained data quality must be evaluated. This can be challenging in complex studies due to a wide scope of examinations, numerous study variables, multiple examiners, devices, and examination centers. This paper describes a Java EE web application used to monitor and evaluate data quality in institutions with complex and multiple studies, named Square 2 . It uses the Java libraries Apache MyFaces 2, extended by BootsFaces for layout and style. RServe and REngine manage calls to R server processes. All study data and metadata are stored in PostgreSQL. R is the statistics backend and LaTeX is used for the generation of print ready PDF reports. A GUI manages the entire workflow. Square 2 covers all steps in the data monitoring workflow, including the setup of studies and their structure, the handling of metadata for data monitoring purposes, selection of variables, upload of data, statistical analyses, and the generation as well as inspection of quality reports. To take into account data protection issues, Square 2 comprises an extensive user rights and roles concept.

Implications of climate variability for monitoring the effectiveness of global mercury policy

NASA Astrophysics Data System (ADS)

Giang, A.; Monier, E.; Couzo, E. A.; Pike-thackray, C.; Selin, N. E.

2016-12-01

We investigate how climate variability affects ability to detect policy-related anthropogenic changes in mercury emissions in wet deposition monitoring data using earth system and atmospheric chemistry modeling. The Minamata Convention, a multilateral environmental agreement that aims to protect human health and the environment from anthropogenic emissions and releases of mercury, includes provisions for monitoring treaty effectiveness. Because meteorology can affect mercury chemistry and transport, internal variability is an important contributor to uncertainty in how effective policy may be in reducing the amount of mercury entering ecosystems through wet deposition. We simulate mercury chemistry using the GEOS-Chem global transport model to assess the influence of meteorology in the context of other uncertainties in mercury cycling and policy. In these simulations, we find that interannual variability in meteorology may be a dominant contributor to the spatial pattern and magnitude of historical regional wet deposition trends. To further assess the influence of climate variability in the GEOS-Chem mercury simulation, we use a 5-member ensemble of meteorological fields from the MIT Integrated Global System Model under present and future climate. Each member involves randomly initialized 20 year simulations centered around 2000 and 2050 (under a no-policy and a climate stabilization scenario). Building on previous efforts to understand climate-air quality interactions for ground-level O3 and particulate matter, we estimate from the ensemble the range of trends in mercury wet deposition given natural variability, and, to extend our previous results on regions that are sensitive to near-source vs. remote anthropogenic signals, we identify geographic regions where mercury wet deposition is most sensitive to this variability. We discuss how an improved understanding of natural variability can inform the Conference of Parties on monitoring strategy and policy ambition.

Blood Glucose Monitoring Before and After Type 1 Diabetes Clinic Visits.

PubMed

Driscoll, Kimberly A; Johnson, Suzanne Bennett; Wang, Yuxia; Wright, Nancy; Deeb, Larry C

2017-12-23

To determine patterns of blood glucose monitoring in children and adolescents with type 1 diabetes (T1D) before and after routine T1D clinic visits. Blood glucose monitoring data were downloaded at four consecutive routine clinic visits from children and adolescents aged 5-18 years. Linear mixed models were used to analyze patterns of blood glucose monitoring in patients who had at least 28 days of data stored in their blood glucose monitors. In general, the frequency of blood glucose monitoring decreased across visits, and younger children engaged in more frequent blood glucose monitoring. Blood glucose monitoring increased before the T1D clinic visits in younger children, but not in adolescents. It declined after the visit regardless of age. Members of the T1D care team need to consider that a T1D clinic visit may prompt an increase in blood glucose monitoring when making treatment changes and recommendations. Tailored interventions are needed to maintain that higher level of adherence across time. © The Author(s) 2017. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Translating glucose variability metrics into the clinic via Continuous Glucose Monitoring: a Graphical User Interface for Diabetes Evaluation (CGM-GUIDE©).

PubMed

Rawlings, Renata A; Shi, Hang; Yuan, Lo-Hua; Brehm, William; Pop-Busui, Rodica; Nelson, Patrick W

2011-12-01

Several metrics of glucose variability have been proposed to date, but an integrated approach that provides a complete and consistent assessment of glycemic variation is missing. As a consequence, and because of the tedious coding necessary during quantification, most investigators and clinicians have not yet adopted the use of multiple glucose variability metrics to evaluate glycemic variation. We compiled the most extensively used statistical techniques and glucose variability metrics, with adjustable hyper- and hypoglycemic limits and metric parameters, to create a user-friendly Continuous Glucose Monitoring Graphical User Interface for Diabetes Evaluation (CGM-GUIDE©). In addition, we introduce and demonstrate a novel transition density profile that emphasizes the dynamics of transitions between defined glucose states. Our combined dashboard of numerical statistics and graphical plots support the task of providing an integrated approach to describing glycemic variability. We integrated existing metrics, such as SD, area under the curve, and mean amplitude of glycemic excursion, with novel metrics such as the slopes across critical transitions and the transition density profile to assess the severity and frequency of glucose transitions per day as they move between critical glycemic zones. By presenting the above-mentioned metrics and graphics in a concise aggregate format, CGM-GUIDE provides an easy to use tool to compare quantitative measures of glucose variability. This tool can be used by researchers and clinicians to develop new algorithms of insulin delivery for patients with diabetes and to better explore the link between glucose variability and chronic diabetes complications.

Swift X-ray monitoring of stellar coronal variability

NASA Astrophysics Data System (ADS)

Miller, Brendan; Hagen, Cedric; Gallo, Elena; Wright, Jason T.

2018-01-01

We used California Planet Search Ca II H and K core emission measurements to identify and characterize chromospheric activity cycles in a sample of main-sequence FGK stars. About a dozen of these with existing ROSAT archival data were targeted with Swift to obtain a current epoch X-ray flux. We find that coronal variability by a factor of several is common on decade-long timescales (we attempt to link to the chromospheric cycle phase) but can also occur on short timescales between Swift visits to a given target, presumably related to stellar rotation and coronal inhomogeneity or to small flares. Additionally, we present new Swift monitoring observations of two M dwarfs with known exoplanets: GJ 15A and GJ 674. GJ 15A b is around 5.3 Earth masses with an 11.4 day orbital period, while GJ 674 is around 11.1 Earth masses with a 4.7 day orbital period. GJ 15A was observed several times in late 2014 and then monitored at approximately weekly intervals for several months in early 2016, for a total exposure of 18 ks. GJ 674 was monitored at approximately weekly intervals for most of 2016, for a total exposure of 40 ks. We provide light curves and hardness ratios for both sources, and also compare to earlier archival X-ray data. Both sources show significant X-ray variability, including between consecutive observations. We quantify the energy distribution for coronal flaring, and compare to optical results for M dwarfs from Kepler. Finally, we discuss the implications of M dwarf coronal activity for exoplanets orbiting within the nominal habitable zone.

Swift X-ray monitoring of stellar coronal variability

NASA Astrophysics Data System (ADS)

Miller, Brendan P.; Gallo, Elena; Wright, Jason; Hagen, Cedric

2017-08-01

We used California Planet Search Ca II H and K core emission measurements to identify and characterize chromospheric activity cycles in a sample of main-sequence FGK stars. About a dozen of these with existing ROSAT archival data were targeted with Swift to obtain a current epoch X-ray flux. We find that coronal variability by a factor of several is common on decade-long timescales (we attempt to link to the chromospheric cycle phase) but can also occur on short timescales between Swift visits to a given target, presumably related to stellar rotation and coronal inhomogeneity or to small flares.Additionally, we present new Swift monitoring observations of two M dwarfs with known exoplanets: GJ 15A and GJ 674. GJ 15A b is around 5.3 Earth masses with an 11.4 day orbital period, while GJ 674 is around 11.1 Earth masses with a 4.7 day orbital period. GJ 15A was observed several times in late 2014 and then monitored at approximately weekly intervals for several months in early 2016, for a total exposure of 18 ks. GJ 674 was monitored at approximately weekly intervals for most of 2016, for a total exposure of 40 ks. We provide light curves and hardness ratios for both sources, and also compare to earlier archival X-ray data. Both sources show significant X-ray variability, including between consecutive observations. We quantify the energy distribution for coronal flaring, and compare to optical results for M dwarfs from Kepler. Finally, we discuss the implications of M dwarf coronal activity for exoplanets orbiting within the nominal habitable zone.

Self-monitored blood pressure: a role in clinical practice?

PubMed

Padfield, Paul L

2002-02-01

Electronic self-monitoring of blood pressure is increasing in popularity and most international guidelines on the management of hypertension approve cautious use of the technique in the assessment of potentially hypertensive individuals. A recent editorial in the Archives of Internal Medicine suggested that it was "appropriate to encourage the widespread use of self recorded BP as an important adjunct to the clinical care of the patient with hypertension". Such a statement is based on increasing evidence that self-monitoring of blood pressure gives similar information to daytime ambulatory blood pressure -- a now well-established technology in the management of hypertension. Suggested strategies for the use of self-monitoring of blood pressure include monitoring in individuals whose clinical risk status is low enough that they need not necessarily be given medical therapy simply on the basis of a clinic pressure (i.e. at a 10 year risk of cardiovascular disease below 20%). The threshold for defining 'normotension/hypertension' is now regarded as being broadly similar for ABPM and SBPM and is set at 135/85 mmHg. In a recent meta-analysis of all available studies the average difference between these techniques, using the same patients, is -1.7/1.2 mmHg. There is some evidence that careful use of self-monitoring may improve blood pressure control in patients who are otherwise resistant to care. Self-monitoring of blood pressure has now been shown in at least one major prospective study to predict outcome better than clinic pressures and in that setting it now has equivalence to the use of ABPM. There remain issues regarding the availability of validated devices, the quality of training of patients in their use and the possibility that inaccurate recording might occur, either deliberately or by accident. Self-monitoring of blood pressure may well not give the same readings as carefully measured blood pressure by research nurses but its use is clearly superior to

Confirming LBV Candidates Through Variability: A Photometric and Spectroscopic Monitoring Study

NASA Astrophysics Data System (ADS)

Stringfellow, Guy; Gvaramadze, Vasilii

2013-02-01

Luminous Blue Variable (LBV) stars represent an extremely rare class of luminous massive stars with high mass loss rates. The paucity ( 12) of confirmed Galactic LBV precludes determining a solid evolutionary connection between LBV and other intermediate (e.g. Ofpe/WN9, WNL) phases in the life of very massive stars. We've been conducting an optical/near-IR spectral survey of a large subset of central stars residing within newly discovered it Spitzer nebulae and have identified over two dozen new candidate LBVs (cLBVs) based on spectral similarity alone; confirming them as bona fide LBVs requires demonstrating 1-3 mag photometric and spectroscopic variability. This marks a significant advancement in the study of massive stars, far outweighing the return from many studies searching for LBVs and WRs the past several decades. Monitoring from semesters 2011B-2012A already has confirmed one new cLBV as a bona fide LBV. We propose to continue optical-IR photometric monitoring of these cLBVS with the 1.3m. Chiron, replacing the RC spectrograph on the 1.5m, now allows high-resolution optical spectroscopic monitoring of bright cLBVs, 11 of which are proposed herein. Spectra are important for understanding the physics driving photometric variability, properties of the wind, and allow analysis of line profiles.

Confirming LBV Candidates Through Variability: A Photometric and Spectroscopic Monitoring Study

NASA Astrophysics Data System (ADS)

Stringfellow, Guy; Gvaramadze, Vasilii

2012-02-01

Luminous Blue Variable (LBV) stars represent an extremely rare class of very luminous, massive stars. About a dozen confirmed Galactic LBV stars are known, which precludes determining a solid evolutionary connection between LBV and other intermediate (e.g. Ofpe/WN9, WNL) phases in the life of very massive stars. Several catalogues of nebulae - rings and shells typical of LBVs - derived from the GLIMPSE and MIPSGAL surveys have recently been published. We conducted a near-IR spectral survey of a large subset of central stars residing within these nebulae and have identified nearly two dozen new candidate LBVs (cLBVs) based on spectral similarity alone; they remain cLBVs until 1-3 mag variability is demonstrated, securing their LBV nature. This marks a significant advancement in the study of massive stars, far outweighing the return from many studies searching for LBVs and WRs the past several decades. Using SMARTS 16 new cLBVs, 3 confirmed LBVs, and 2 previously known cLBVs will undergo photometric IR-monitoring, with 6 new cLBVs monitored spectroscopically (already being photometrically monitored elsewhere).

Confirming LBV Candidates Through Variability: A Photometric and Spectroscopic Monitoring Study

NASA Astrophysics Data System (ADS)

Stringfellow, Guy; Gvaramadze, Vasilii

2011-08-01

Luminous Blue Variable (LBV) stars represent an extremely rare class of very luminous, massive stars. About a dozen confirmed Galactic LBV stars are known, which precludes determining a solid evolutionary connection between LBV and other intermediate (e.g. Ofpe/WN9, WNL) phases in the life of very massive stars. Several catalogues of nebulae - rings and shells typical of LBVs - derived from the GLIMPSE and MIPSGAL surveys have recently been published. We conducted a near-IR spectral survey of a large subset of central stars residing within these nebulae and have identified nearly two dozen new candidate LBVs (cLBVs) based on spectral similarity alone; they remain cLBVs until 1-3 mag variability is demonstrated, securing their LBV nature. This marks a significant advancement in the study of massive stars, far outweighing the return from many studies searching for LBVs and WRs the past several decades. Using SMARTS 16 new cLBVs, 3 confirmed LBVs, and 2 previously known cLBVs will undergo photometric IR-monitoring, with 6 new cLBVs monitored spectroscopically (already being photometrically monitored elsewhere).

BioMEMS for multiparameter clinical monitoring

NASA Astrophysics Data System (ADS)

Moser, Isabella

2003-01-01

For diabetes patients glucose monitoring means an important improvement of their life quality and additionally it is a $3-billion-a-year business. Continuous glucose monitoring provides gapless glucose level control, an early warning of hypoglycemia, and is intended to control insulin pumps. An upgrading to multi-parameter monitoring would not only benefit patients with severe metabolism defects but also the metabolism of diabetes patient could be better controlled by monitoring an additional parameter like lactate. Multi-parameter monitoring devices are not commercially available, one of the complications in the integration of different biosensors using the same detecting molecule for all analytes is chemical cross talk between adjacent amperometric biosensors. Recently some integrated biosensors were published but either they were not mass producible or they were realized in an expensive silicon based technology. In addition to it most of them were not tested under monitoring conditions but their integration principles will be discussed. As an example a low cost multi- parameter microsystem and some applications of it in clinical diagnosis will be presented. Also an overlook of non-invasive methods and (minimal) invasive methods will be given with a focus on microdialysis.

Drought is Coming: Monitoring Vegetation Response to Water Scarcity through Variable Chlorophyll a Fluorescence

NASA Astrophysics Data System (ADS)

Guadagno, C. R.; Beverly, D.; Pleban, J. R.; Speckman, H. N.; Ewers, B. E.; Weinig, C.

2017-12-01

Aridity is one of the most pronounced environmental limits to plant survival, and understanding how plants respond to drought and recovery is crucial for predicting impacts on managed and natural ecosystems. Changes in soil moisture conditions induce a suite of physiological responses from the cell to ecosystem scale, complicating the assessment of drought effects. Characterizing early indicators of water scarcity across species can inform biophysical models with improved understanding of plant hydraulics. While indexes exist for drought monitoring across scales, many are unable to identify imminent vegetative drought. We explore a method of early diagnosis using leaf-level and kinetic imaging measures of variable chlorophyll a fluorescence. This is a fast and reliable tool capturing leaf physiological changes in advance of changes in NDVI or passive solar induced fluorescence. Both image and leaf level Pulse Amplitude Method (PAM) measurements illustrate the utility of variable chlorophyll a fluorescence for monitoring vegetative drought. Variable fluorescence was monitored across populations of crops, desert shrubs, montane conifers and riparian deciduous trees under variable water regimes. We found a strong correlation (R = 0.85) between the maximum efficiency of photosystem II measured using variable fluorescence (Fv'Fm') and leaf level electrolyte leakage, a proximal cause of drought stress induced by cellular damage in leaves. This association was confirmed in two gymnosperm species (Picea engelmannii and Pinus contorta) and for diverse varieties of the crop species Brassica rapa. The use of chlorophyll a fluorescence per image also allowed for early detection of drought in aspen (Populus tremuloides). These results provide evidence that variable chlorophyll fluorescence decreases between 25% and 70% in mild and severely droughted twigs with respect to ones collected from trees in wet soil conditions. While current systems for monitoring variable fluorescence

Monitoring the fetal heart rate variability during labor.

PubMed

Moslem, B; Mohydeen, A; Bazzi, O

2015-08-01

In respect to the main goal of our ongoing work for estimating the heart rate variability (HRV) from fetal electrocardiogram (FECG) signals for monitoring the health of the fetus, we investigate in this paper the possibility of extracting the fetal heart rate variability (HRV) directly from the abdominal composite recordings. Our proposed approach is based on a combination of two techniques: Periodic Component Analysis (PiCA) and recursive least square (RLS) adaptive filtering. The Fetal HRV of the estimated FECG signal is compared to a reference value extracted from an FECG signal recorded by using a spiral electrode attached directly to the fetal scalp. The results obtained show that the fetal HRV can be directly evaluated from the abdominal composite recordings without the need of recording an external reference signal.

Translating Glucose Variability Metrics into the Clinic via Continuous Glucose Monitoring: A Graphical User Interface for Diabetes Evaluation (CGM-GUIDE©)

PubMed Central

Rawlings, Renata A.; Shi, Hang; Yuan, Lo-Hua; Brehm, William; Pop-Busui, Rodica

2011-01-01

Abstract Background Several metrics of glucose variability have been proposed to date, but an integrated approach that provides a complete and consistent assessment of glycemic variation is missing. As a consequence, and because of the tedious coding necessary during quantification, most investigators and clinicians have not yet adopted the use of multiple glucose variability metrics to evaluate glycemic variation. Methods We compiled the most extensively used statistical techniques and glucose variability metrics, with adjustable hyper- and hypoglycemic limits and metric parameters, to create a user-friendly Continuous Glucose Monitoring Graphical User Interface for Diabetes Evaluation (CGM-GUIDE©). In addition, we introduce and demonstrate a novel transition density profile that emphasizes the dynamics of transitions between defined glucose states. Results Our combined dashboard of numerical statistics and graphical plots support the task of providing an integrated approach to describing glycemic variability. We integrated existing metrics, such as SD, area under the curve, and mean amplitude of glycemic excursion, with novel metrics such as the slopes across critical transitions and the transition density profile to assess the severity and frequency of glucose transitions per day as they move between critical glycemic zones. Conclusions By presenting the above-mentioned metrics and graphics in a concise aggregate format, CGM-GUIDE provides an easy to use tool to compare quantitative measures of glucose variability. This tool can be used by researchers and clinicians to develop new algorithms of insulin delivery for patients with diabetes and to better explore the link between glucose variability and chronic diabetes complications. PMID:21932986

Simultaneous Monitoring of X-Ray and Radio Variability in Sagittarius A*

NASA Astrophysics Data System (ADS)

Capellupo, Daniel M.; Haggard, Daryl; Choux, Nicolas; Baganoff, Fred; Bower, Geoffrey C.; Cotton, Bill; Degenaar, Nathalie; Dexter, Jason; Falcke, Heino; Fragile, P. Chris; Heinke, Craig O.; Law, Casey J.; Markoff, Sera; Neilsen, Joey; Ponti, Gabriele; Rea, Nanda; Yusef-Zadeh, Farhad

2017-08-01

Monitoring of Sagittarius A* from X-ray to radio wavelengths has revealed structured variability—including X-ray flares—but it is challenging to establish correlations between them. Most studies have focused on variability in the X-ray and infrared, where variations are often simultaneous, and because long time series at submillimeter and radio wavelengths are limited. Previous work on submillimeter and radio variability hints at a lag between X-ray flares and their candidate submillimeter or radio counterparts, with the long wavelength data lagging the X-ray. However, there is only one published time lag between an X-ray flare and a possible radio counterpart. Here we report nine contemporaneous X-ray and radio observations of Sgr A*. We detect significant radio variability peaking ≳ 176 minutes after the brightest X-ray flare ever detected from Sgr A*. We also report other potentially associated X-ray and radio variability, with the radio peaks appearing ≲ 80 minutes after these weaker X-ray flares. Taken at face value, these results suggest that stronger X-ray flares lead to longer time lags in the radio. However, we also test the possibility that the variability at X-ray and radio wavelengths is not temporally correlated. We cross-correlate data from mismatched X-ray and radio epochs and obtain comparable correlations to the matched data. Hence, we find no overall statistical evidence that X-ray flares and radio variability are correlated, underscoring a need for more simultaneous, long duration X-ray-radio monitoring of Sgr A*.

Continuous glucose monitoring: A review of the technology and clinical use.

PubMed

Klonoff, David C; Ahn, David; Drincic, Andjela

2017-11-01

Continuous glucose monitoring (CGM) is an increasingly adopted technology for insulin-requiring patients that provides insights into glycemic fluctuations. CGM can assist patients in managing their diabetes with lifestyle and medication adjustments. This article provides an overview of the technical and clinical features of CGM based on a review of articles in PubMed on CGM from 1999 through January 31, 2017. A detailed description is presented of three professional (retrospective), three personal (real-time) continuous glucose monitors, and three sensor integrated pumps (consisting of a sensor and pump that communicate with each other to determine an optimal insulin dose and adjust the delivery of insulin) that are currently available in United States. We have reviewed outpatient CGM outcomes, focusing on hemoglobin A1c (A1C), hypoglycemia, and quality of life. Issues affecting accuracy, detection of glycemic variability, strategies for optimal use, as well as cybersecurity and future directions for sensor design and use are discussed. In conclusion, CGM is an important tool for monitoring diabetes that has been shown to improve outcomes in patients with type 1 diabetes mellitus. Given currently available data and technological developments, we believe that with appropriate patient education, CGM can also be considered for other patient populations. Copyright © 2017 Elsevier B.V. All rights reserved.

Monitoring-Based Model for Personalizing the Clinical Process of Crohn’s Disease

PubMed Central

de Ramón-Fernández, Alberto; Ruiz-Fernández, Daniel; Vives-Boix, Víctor

2017-01-01

Crohn’s disease is a chronic pathology belonging to the group of inflammatory bowel diseases. Patients suffering from Crohn’s disease must be supervised by a medical specialist for the rest of their lives; furthermore, each patient has its own characteristics and is affected by the disease in a different way, so health recommendations and treatments cannot be generalized and should be individualized for a specific patient. To achieve this personalization in a cost-effective way using technology, we propose a model based on different information flows: control, personalization, and monitoring. As a result of the model and to perform a functional validation, an architecture based on services and a prototype of the system has been defined. In this prototype, a set of different devices and technologies to monitor variables from patients and their environment has been integrated. Artificial intelligence algorithms are also included to reduce the workload related to the review and analysis of the information gathered. Due to the continuous and automated monitoring of the Crohn’s patient, this proposal can help in the personalization of the Crohn’s disease clinical process. PMID:28678162

Identifying optimal remotely-sensed variables for ecosystem monitoring in Colorado Plateau drylands

USGS Publications Warehouse

Poitras, Travis; Villarreal, Miguel; Waller, Eric K.; Nauman, Travis; Miller, Mark E.; Duniway, Michael C.

2018-01-01

Water-limited ecosystems often recover slowly following anthropogenic or natural disturbance. Multitemporal remote sensing can be used to monitor ecosystem recovery after disturbance; however, dryland vegetation cover can be challenging to accurately measure due to sparse cover and spectral confusion between soils and non-photosynthetic vegetation. With the goal of optimizing a monitoring approach for identifying both abrupt and gradual vegetation changes, we evaluated the ability of Landsat-derived spectral variables to characterize surface variability of vegetation cover and bare ground across a range of vegetation community types. Using three year composites of Landsat data, we modeled relationships between spectral information and field data collected at monitoring sites near Canyonlands National Park, UT. We also developed multiple regression models to assess improvement over single variables. We found that for all vegetation types, percent cover bare ground could be accurately modeled with single indices that included a combination of red and shortwave infrared bands, while near infrared-based vegetation indices like NDVI worked best for quantifying tree cover and total live vegetation cover in woodlands. We applied four models to characterize the spatial distribution of putative grassland ecological states across our study area, illustrating how this approach can be implemented to guide dryland ecosystem management.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Therapeutic Drug Monitoring of Lacosamide in Norway: Focus on Pharmacokinetic Variability, Efficacy and Tolerability.

PubMed

Svendsen, Torleiv; Brodtkorb, Eylert; Baftiu, Arton; Burns, Margrete Larsen; Johannessen, Svein I; Johannessen Landmark, Cecilie

2017-07-01

Lacosamide (LCM) is a new antiepileptic drug (AED). Experience from therapeutic drug monitoring (TDM) in clinical practice is limited. The purpose of this study is to evaluate the pharmacokinetic variability of LCM in relation to efficacy and tolerability in patients with refractory epilepsy in a real-life setting. Variables included age, gender, daily doses and serum concentrations of LCM and other AEDs from the TDM-database at the National Center for Epilepsy in Norway. Clinical data regarding efficacy and tolerability were collected from medical records. The Norwegian Prescription Database (NorPD) was used to include population-based numbers of users. TDM-data from 344 patients were included. The median dose, serum concentration, and concentration/dose (C/D)-ratio of LCM was 350 (range 25-700) mg/day, 19.7 (range 8.1-56.2) µmol/L, and 0.06 (0.02-0.82) µmol/L/mg, respectively. Serum concentrations were reduced by 28% by concomitant use of enzyme inducers and increased by 30% in patients aged >65 years. Efficacy and tolerability were assessed in 227 patients: 29% had >50% seizure reduction (eight seizure free), 30% had no effect, and 44% reported adverse effects. In Norway, there were on average 500 patients per year using LCM in this period based on NorPD. The study demonstrated pharmacokinetic variability and use of TDM of LCM in Norway. Data were collected from multiple sources for improved pharmacovigilance. Serum concentrations were influenced by enzyme inducers and ageing, indicating the usefulness of TDM. Effect and tolerability were favorable within a suggested reference range of 10-40 µmol/L given drug-fasting conditions.

Use of electronic monitoring in clinical nursing research.

PubMed

Ailinger, Rita L; Black, Patricia L; Lima-Garcia, Natalie

2008-05-01

In the past decade, the introduction of electronic monitoring systems for monitoring medication adherence has contributed to the dialog about what works and what does not work in monitoring adherence. The purpose of this article is to describe the use of the Medication Event Monitoring System (MEMS) in a study of patients receiving isoniazid for latent tuberculosis infection. Three case examples from the study illustrate the data that are obtained from the electronic device compared to self-reports and point to the disparities that may occur in electronic monitoring. The strengths and limitations of using the MEMS and ethical issues in utilizing this technology are discussed. Nurses need to be aware of these challenges when using electronic measuring devices to monitor medication adherence in clinical nursing practice and research.

Rapid-cadence optical monitoring for short-period variability of ɛ Aurigae

NASA Astrophysics Data System (ADS)

Billings, Gary

2013-07-01

ɛ Aurigae was observed with CCD cameras and 35 mm SLR camera lenses, at rapid cadence (>1/minute), for long runs (up to 11 hours), on multiple occasions during 2009 - 2011, to monitor for variability of the system at scales of minutes to hours. The lens and camera were changed during the period to improve results, finalizing on a 135 mm focal length Canon f/2 lens (at f/2.8), an ND8 neutral density filter, a Johnson V filter, and an SBIG ST-8XME camera (Kodak KAF-1603ME microlensed chip). Differential photometry was attempted, but because of the large separation between the variable and comparison star (η Aur), noise caused by transient extinction variations was not consistently eliminated. The lowest-noise time series for searching for short-period variability proved to be the extinction-corrected instrumental magnitude of ɛ Aur obtained on "photometric nights", with η Aur used to determine and monitor the extinction coefficient for the night. No flares or short-period variations of ɛ Aur were detected by visual inspection of the light curves from observing runs with noise levels as low as 0.008 magnitudes rms.

Use of High Resolution Mobile Monitoring Techniques to Assess Near Road Air Quality Variability

EPA Science Inventory

This presentation provides a description of the techniques used to develop and conduct effective mobile monitoring studies. It also provides a summary of mobile monitoring assessment studies that have been used to assess near-road concentrations and the variability of pollutant l...

Use of High Resolution Mobile Monitoring Techniques to Assess Near-Road Air Quality Variability

EPA Science Inventory

This presentation provides a description of the techniques used to develop and conduct effective mobile monitoring studies. It also provides a summary of mobile monitoring assessment studies that have been used to assess near-road concentrations and the variability of pollutant l...

Monitoring Cepheid variables using the new BYU Observation Deck Robotic Telescopes

NASA Astrophysics Data System (ADS)

Bugg, Adam Garth; Hintz, Eric G.; Joner, Michael D.

2018-01-01

In January 2017 work was completed on the new observation deck of the Eyring Science Center on the Brigham Young University campus. This deck was designed with pedestals to currently hold up to 5 robotic telescope systems. One of the first test projects was to monitor a sample of Classical Cepheid variables to watch for changes in the light curves. Starting with a sample of stars which had previously been monitored spectroscopically using the Dominion Astrophysical Observatory 1.2-m telescope, we collected photometric data in the H-alpha/H-beta system detailed in Joner & Hintz (2015). We will present a preliminary analysis of this data and the abilities of the new deck to monitor these type of objects.

Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

PubMed

Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

2016-07-01

The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Analytical and Clinical Performance of Blood Glucose Monitors

PubMed Central

Boren, Suzanne Austin; Clarke, William L.

2010-01-01

Background The objective of this study was to understand the level of performance of blood glucose monitors as assessed in the published literature. Methods Medline from January 2000 to October 2009 and reference lists of included articles were searched to identify eligible studies. Key information was abstracted from eligible studies: blood glucose meters tested, blood sample, meter operators, setting, sample of people (number, diabetes type, age, sex, and race), duration of diabetes, years using a glucose meter, insulin use, recommendations followed, performance evaluation measures, and specific factors affecting the accuracy evaluation of blood glucose monitors. Results Thirty-one articles were included in this review. Articles were categorized as review articles of blood glucose accuracy (6 articles), original studies that reported the performance of blood glucose meters in laboratory settings (14 articles) or clinical settings (9 articles), and simulation studies (2 articles). A variety of performance evaluation measures were used in the studies. The authors did not identify any studies that demonstrated a difference in clinical outcomes. Examples of analytical tools used in the description of accuracy (e.g., correlation coefficient, linear regression equations, and International Organization for Standardization standards) and how these traditional measures can complicate the achievement of target blood glucose levels for the patient were presented. The benefits of using error grid analysis to quantify the clinical accuracy of patient-determined blood glucose values were discussed. Conclusions When examining blood glucose monitor performance in the real world, it is important to consider if an improvement in analytical accuracy would lead to improved clinical outcomes for patients. There are several examples of how analytical tools used in the description of self-monitoring of blood glucose accuracy could be irrelevant to treatment decisions. PMID:20167171

Systematic Therapeutic Drug Monitoring for Linezolid: Variability and Clinical Impact

PubMed Central

Valerio, Maricela; Muñoz, Patricia; Alcalá, Luis; García-González, Xandra; Burillo, Almudena; Sanjurjo, María; Grau, Santiago

2017-01-01

ABSTRACT Linezolid serum trough (Cmin) and peak (Cmax) levels were determined prospectively in 90 patients. Adequate exposure was defined as a Cmin of 2 to 8 mg/liter. Therapy was empirical (73.3%) or targeted (26.7%). Wide interindividual variability in linezolid Cmin levels was recorded (0.1 to 25.2 μg/ml). Overall, 65.5% of the patients had out-of-range, 41.1% had subtherapeutic, and 24.4% had supratherapeutic trough levels. We did not find a correlation between abnormal levels and adverse events, in-hospital mortality, or overall poor outcome. PMID:28739788

Ambulatory and home blood pressure monitoring: gaps between clinical guidelines and clinical practice in Singapore

PubMed Central

Setia, Sajita; Subramaniam, Kannan; Teo, Boon Wee; Tay, Jam Chin

2017-01-01

Purpose Out-of-office blood pressure (BP) measurements (home blood pressure monitoring [HBPM] and ambulatory blood pressure monitoring [ABPM]) provide important additional information for effective hypertension detection and management decisions. Therefore, out-of-office BP measurement is now recommended by several international guidelines. This study evaluated the practice and uptake of HBPM and ABPM among physicians from Singapore. Materials and methods A sample of physicians from Singapore was surveyed between 8 September and 5 October 2016. Those included were in public or private practice had been practicing for ≥3 years, directly cared for patients ≥70% of the time, and treated ≥30 patients for hypertension per month. The questionnaire covered six main categories: general BP management, BP variability (BPV) awareness/diagnosis, HBPM, ABPM, BPV management, and associated training needs. Results Sixty physicians (30 general practitioners, 20 cardiologists, and 10 nephrologists) were included (77% male, 85% aged 31–60 years, and mean 22-year practice). Physicians recommended HBPM and ABPM to 81% and 27% of hypertensive patients, respectively. HBPM was most often used to monitor antihypertensive therapy (88% of physicians) and 97% thought that ABPM was useful for providing information on BPV. HBPM instructions often differed from current guideline recommendations in terms of frequency, number of measurements, and timing. The proportion of consultation time devoted to discussing HBPM and BPV was one-quarter or less for 73% of physicians, and only 55% said that they had the ability to provide education on HBPM and BPV. Patient inertia, poor patient compliance, lack of medical consultation time, and poor patient access to a BP machine were the most common challenges for implementing out-of-office BP monitoring. Conclusion Although physicians from Singapore do recommend out-of-office BP measurement to patients with hypertension, this survey identified several

Ambulatory and home blood pressure monitoring: gaps between clinical guidelines and clinical practice in Singapore.

PubMed

Setia, Sajita; Subramaniam, Kannan; Teo, Boon Wee; Tay, Jam Chin

2017-01-01

Out-of-office blood pressure (BP) measurements (home blood pressure monitoring [HBPM] and ambulatory blood pressure monitoring [ABPM]) provide important additional information for effective hypertension detection and management decisions. Therefore, out-of-office BP measurement is now recommended by several international guidelines. This study evaluated the practice and uptake of HBPM and ABPM among physicians from Singapore. A sample of physicians from Singapore was surveyed between 8 September and 5 October 2016. Those included were in public or private practice had been practicing for ≥3 years, directly cared for patients ≥70% of the time, and treated ≥30 patients for hypertension per month. The questionnaire covered six main categories: general BP management, BP variability (BPV) awareness/diagnosis, HBPM, ABPM, BPV management, and associated training needs. Sixty physicians (30 general practitioners, 20 cardiologists, and 10 nephrologists) were included (77% male, 85% aged 31-60 years, and mean 22-year practice). Physicians recommended HBPM and ABPM to 81% and 27% of hypertensive patients, respectively. HBPM was most often used to monitor antihypertensive therapy (88% of physicians) and 97% thought that ABPM was useful for providing information on BPV. HBPM instructions often differed from current guideline recommendations in terms of frequency, number of measurements, and timing. The proportion of consultation time devoted to discussing HBPM and BPV was one-quarter or less for 73% of physicians, and only 55% said that they had the ability to provide education on HBPM and BPV. Patient inertia, poor patient compliance, lack of medical consultation time, and poor patient access to a BP machine were the most common challenges for implementing out-of-office BP monitoring. Although physicians from Singapore do recommend out-of-office BP measurement to patients with hypertension, this survey identified several important gaps in knowledge and clinical practice.

Increase of Short-Term Heart Rate Variability Induced by Blood Pressure Measurements during Ambulatory Blood Pressure Monitoring.

PubMed

Frigy, Attila; Magdás, Annamária; Moga, Victor-Dan; Coteț, Ioana Georgiana; Kozlovszky, Miklós; Szilágyi, László

2017-01-01

Objective. The possible effect of blood pressure measurements per se on heart rate variability (HRV) was studied in the setting of concomitant ambulatory blood pressure monitoring (ABPM) and Holter ECG monitoring (HM). Methods. In 25 hypertensive patients (14 women and 11 men, mean age: 58.1 years), 24-hour combined ABPM and HM were performed. For every blood pressure measurement, 2-minute ECG segments (before, during, and after measurement) were analyzed to obtain time domain parameters of HRV: SDNN and rMSSD. Mean of normal RR intervals (MNN), SDNN/MNN, and rMSSD/MNN were calculated, too. Parameter variations related to blood pressure measurements were analyzed using one-way ANOVA with multiple comparisons. Results. 2281 measurements (1518 during the day and 763 during the night) were included in the analysis. Both SDNN and SDNN/MNN had a constant (the same for 24-hour, daytime, and nighttime values) and significant change related to blood pressure measurements: an increase during measurements and a decrease after them ( p < 0.01 for any variation). Conclusion. In the setting of combined ABPM and HM, the blood pressure measurement itself produces an increase in short-term heart rate variability. Clarifying the physiological basis and the possible clinical value of this phenomenon needs further studies.

Cataclysmic variables to be monitored for HST observations

NASA Astrophysics Data System (ADS)

Waagen, Elizabeth O.

2012-09-01

Drs. Boris Gaensicke (Warwick University), Joseph Patterson (Columbia University, Center for Backyard Astrophysics), and Arne Henden (AAVSO), on behalf of a consortium of 16 astronomers, requested the help of AAVSO observers in monitoring the ~40 cataclysmic variables in support of Hubble Space Telescope observations in the coming months. The HST COS (Cosmic Origins Spectrograph) will be carrying out far-ultraviolet spectroscopy of ~40 CVs sequentially, with the aim to measure the temperatures, atmospheric compositions, rotation rates, and eventually masses of their white dwarfs. The primary purpose of the monitoring is to know whether each target is in quiescence immediately prior to the observation window; if it is in outburst it will be too bright for the HST instrumentation. Based on the information supplied by the AAVSO, the HST scheduling team will make the decision (usually) the evening before the scheduled observing time as to whether to go forward with the HST observations. For CCD observers, simultaneous photometry [shortly before, during, and after the HST observations] would be ideal. B filter would be best for a light curve, although for the magnitude estimates, V would be best. Finder charts may be created using the AAVSO Variable Star Plotter (http://www.aavso.org/vsp). Observations should be submitted to the AAVSO International Database. If the target is seen in outburst, please contact the AAVSO immediately and post a message to the Observations and Campaigns & Observations Reports forum (http://www.aavso.org/forum). This campaign will run the better part of a year or longer. See full Alert Notice for more details and list of objects.

Wireless Monitoring of Induction Machine Rotor Physical Variables

PubMed Central

Doolan Fernandes, Jefferson; Carvalho Souza, Francisco Elvis; de Paiva, José Alvaro

2017-01-01

With the widespread use of electric machines, there is a growing need to extract information from the machines to improve their control systems and maintenance management. The present work shows the development of an embedded system to perform the monitoring of the rotor physical variables of a squirrel cage induction motor. The system is comprised of: a circuit to acquire desirable rotor variable(s) and value(s) that send it to the computer; a rectifier and power storage circuit that converts an alternating current in a continuous current but also stores energy for a certain amount of time to wait for the motor’s shutdown; and a magnetic generator that harvests energy from the rotating field to power the circuits mentioned above. The embedded system is set on the rotor of a 5 HP squirrel cage induction motor, making it difficult to power the system because it is rotating. This problem can be solved with the construction of a magnetic generator device to avoid the need of using batteries or collector rings and will send data to the computer using a wireless NRF24L01 module. For the proposed system, initial validation tests were made using a temperature sensor (DS18b20), as this variable is known as the most important when identifying the need for maintenance and control systems. Few tests have shown promising results that, with further improvements, can prove the feasibility of using sensors in the rotor. PMID:29156564

Wireless Monitoring of Induction Machine Rotor Physical Variables.

PubMed

Doolan Fernandes, Jefferson; Carvalho Souza, Francisco Elvis; Cipriano Maniçoba, Glauco George; Salazar, Andrés Ortiz; de Paiva, José Alvaro

2017-11-18

With the widespread use of electric machines, there is a growing need to extract information from the machines to improve their control systems and maintenance management. The present work shows the development of an embedded system to perform the monitoring of the rotor physical variables of a squirrel cage induction motor. The system is comprised of: a circuit to acquire desirable rotor variable(s) and value(s) that send it to the computer; a rectifier and power storage circuit that converts an alternating current in a continuous current but also stores energy for a certain amount of time to wait for the motor's shutdown; and a magnetic generator that harvests energy from the rotating field to power the circuits mentioned above. The embedded system is set on the rotor of a 5 HP squirrel cage induction motor, making it difficult to power the system because it is rotating. This problem can be solved with the construction of a magnetic generator device to avoid the need of using batteries or collector rings and will send data to the computer using a wireless NRF24L01 module. For the proposed system, initial validation tests were made using a temperature sensor (DS18b20), as this variable is known as the most important when identifying the need for maintenance and control systems. Few tests have shown promising results that, with further improvements, can prove the feasibility of using sensors in the rotor.

Childhood Depression: Relation to Adaptive, Clinical and Predictor Variables

PubMed Central

Garaigordobil, Maite; Bernarás, Elena; Jaureguizar, Joana; Machimbarrena, Juan M.

2017-01-01

The study had two goals: (1) to explore the relations between self-assessed childhood depression and other adaptive and clinical variables (2) to identify predictor variables of childhood depression. Participants were 420 students aged 7–10 years old (53.3% boys, 46.7% girls). Results revealed: (1) positive correlations between depression and clinical maladjustment, school maladjustment, emotional symptoms, internalizing and externalizing problems, problem behaviors, emotional reactivity, and childhood stress; and (2) negative correlations between depression and personal adaptation, global self-concept, social skills, and resilience (sense of competence and affiliation). Linear regression analysis including the global dimensions revealed 4 predictors of childhood depression that explained 50.6% of the variance: high clinical maladjustment, low global self-concept, high level of stress, and poor social skills. However, upon introducing the sub-dimensions, 9 predictor variables emerged that explained 56.4% of the variance: many internalizing problems, low family self-concept, high anxiety, low responsibility, low personal self-assessment, high social stress, few aggressive behaviors toward peers, many health/psychosomatic problems, and external locus of control. The discussion addresses the importance of implementing prevention programs for childhood depression at early ages. PMID:28572787

Population Pharmacokinetics of Intravenous Methotrexate in Patients with Hematological Malignancies: Utilization of Routine Clinical Monitoring Parameters.

PubMed

Nader, Ahmed; Zahran, Noran; Alshammaa, Aya; Altaweel, Heba; Kassem, Nancy; Wilby, Kyle John

2017-04-01

Clinical response to methotrexate in cancer is variable and depends on several factors including serum drug exposure. This study aimed to develop a population pharmacokinetic model describing methotrexate disposition in cancer patients using retrospective chart review data available from routine clinical practice. A retrospective review of medical records was conducted for cancer patients in Qatar. Relevant data (methotrexate dosing/concentrations from multiple occasions, patient history, and laboratory values) were extracted and analyzed using NONMEM VII ® . A population pharmacokinetic model was developed and used to estimate inter-individual and inter-occasion variability terms on methotrexate pharmacokinetic parameters, as well as patient factors affecting methotrexate pharmacokinetics. Methotrexate disposition was described by a two-compartment model with clearance (CL) of 15.7 L/h and central volume of distribution (V c ) of 79.2 L. Patient weight and hematocrit levels were significant covariates on methotrexate V c and CL, respectively. Methotrexate CL changed by 50 % with changes in hematocrit levels from 23 to 50 %. Inter-occasion variability in methotrexate CL was estimated for patients administered the drug on multiple occasions (48 and 31 % for 2nd and 3rd visits, respectively). Therapeutic drug monitoring data collected during routine clinical practice can provide a useful tool for understanding factors affecting methotrexate pharmacokinetics. Patient weight and hematocrit levels may play a clinically important role in determining methotrexate serum exposure and dosing requirements. Future prospective studies are needed to validate results of the developed model and evaluate its usefulness to predict methotrexate exposure and optimize dosing regimens.

Definition of variables required for comprehensive description of drug dosage and clinical pharmacokinetics.

PubMed

Medem, Anna V; Seidling, Hanna M; Eichler, Hans-Georg; Kaltschmidt, Jens; Metzner, Michael; Hubert, Carina M; Czock, David; Haefeli, Walter E

2017-05-01

Electronic clinical decision support systems (CDSS) require drug information that can be processed by computers. The goal of this project was to determine and evaluate a compilation of variables that comprehensively capture the information contained in the summary of product characteristic (SmPC) and unequivocally describe the drug, its dosage options, and clinical pharmacokinetics. An expert panel defined and structured a set of variables and drafted a guideline to extract and enter information on dosage and clinical pharmacokinetics from textual SmPCs as published by the European Medicines Agency (EMA). The set of variables was iteratively revised and evaluated by data extraction and variable allocation of roughly 7% of all centrally approved drugs. The information contained in the SmPC was allocated to three information clusters consisting of 260 variables. The cluster "drug characterization" specifies the nature of the drug. The cluster "dosage" provides information on approved drug dosages and defines corresponding specific conditions. The cluster "clinical pharmacokinetics" includes pharmacokinetic parameters of relevance for dosing in clinical practice. A first evaluation demonstrated that, despite the complexity of the current free text SmPCs, dosage and pharmacokinetic information can be reliably extracted from the SmPCs and comprehensively described by a limited set of variables. By proposing a compilation of variables well describing drug dosage and clinical pharmacokinetics, the project represents a step forward towards the development of a comprehensive database system serving as information source for sophisticated CDSS.

Ambulatory Blood Pressure Monitoring in Clinical Practice: A Review

PubMed Central

Viera, Anthony J.; Shimbo, Daichi

2016-01-01

Ambulatory blood pressure monitoring offers the ability to collect blood pressure readings several times an hour across a 24-hour period. Ambulatory blood pressure monitoring facilitates the identification of white-coat hypertension, the phenomenon whereby certain individuals who are not on antihypertensive medication show elevated blood pressure in a clinical setting but show non-elevated blood pressure averages when assessed by ambulatory blood pressure monitoring. Additionally, readings can be segmented into time windows of particular interest, e.g., mean daytime and nighttime values. During sleep, blood pressure typically decreases, or dips, such that mean sleep blood pressure is lower than mean awake blood pressure. A non-dipping pattern and nocturnal hypertension are strongly associated with increased cardiovascular morbidity and mortality. Approximately 70% of individuals dip ≥10% at night, while 30% have non-dipping patterns, when blood pressure remains similar to daytime average, or occasionally rises above daytime average. The various blood pressure categorizations afforded by ambulatory blood pressure monitoring are valuable for clinical management of high blood pressure since they increase accuracy for diagnosis and the prediction of cardiovascular risk. PMID:25107387

Current concepts in blood glucose monitoring

PubMed Central

Khadilkar, Kranti Shreesh; Bandgar, Tushar; Shivane, Vyankatesh; Lila, Anurag; Shah, Nalini

2013-01-01

Blood glucose monitoring has evolved over the last century. The concept of adequate glycemic control and minimum glycemic variability requires an ideal, accurate and reliable glucose monitoring system. The search for an ideal blood glucose monitoring system still continues. This review explains the various blood glucose monitoring systems with special focus on the monitoring systems like self- monitored blood glucose (SMBG) and continuous glucose monitoring system (CGMS). It also focuses on the newer concepts of blood glucose monitoring and their incorporation in routine clinical management of diabetes mellitus. PMID:24910827

Clinical Performance and Admission Variables as Predictors of Passage of the National Physical Therapy Examination.

PubMed

Meiners, Kelly M; Rush, Douglas K

2017-01-01

Prior studies have explored variables that had predictive relationships with National Physical Therapy Examination (NPTE) score or NPTE failure. The purpose of this study was to explore whether certain variables were predictive of test-takers' first-time score on the NPTE. The population consisted of 134 students who graduated from the university's Professional DPT Program in 2012 to 2014. This quantitative study used a retrospective design. Two separate data analyses were conducted. First, hierarchical linear multiple regression (HMR) analysis was performed to determine which variables were predictive of first-time NPTE score. Second, a correlation analysis was performed on all 18 Physical Therapy Clinical Performance Instrument (PT CPI) 2006 category scores obtained during the first long-term clinical rotation, overall PT CPI 2006 score, and NPTE passage. With all variables entered, the HMR model predicted 39% of the variance seen in NPTE scores. The HMR results showed that physical therapy program first-year GPA (1PTGPA) was the strongest predictor and explained 24% of the variance in NPTE scores (b=0.572, p<0.001). The correlational analysis found no statistically significant correlation between the 18 PT CPI 2006 category scores, overall PT CPI 2006 score, and NPTE passage. As 1PTGPA had the most significant contribution to prediction of NPTE scores, programs need to monitor first-year students who display academic difficulty. PT CPI version 2006 scores were significantly correlated with each other, but not with NPTE score or NPTE passage. Both tools measure many of the same professional requirements but use different modes of assessment, and they may be considered complementary tools to gain a full picture of both the student's ability and skills.

First Clinical Experience with Retrospective Flash Glucose Monitoring (FGM) Analysis in South Africa: Characterizing Glycemic Control with Ambulatory Glucose Profile.

PubMed

Distiller, Larry A; Cranston, Iain; Mazze, Roger

2016-11-01

In 2014, an innovative blinded continuous glucose monitoring system was introduced with automated ambulatory glucose profile (AGP) reporting. The clinical use and interpretation of this new technology has not previously been described. Therefore we wanted to understand its use in characterizing key factors related to glycemic control: glucose exposure, variability, and stability, and risk of hypoglycemia in clinical practice. Clinicians representing affiliated diabetes centers throughout South Africa were trained and subsequently were given flash glucose monitoring readers and 2-week glucose sensors to use at their discretion. After patient use, sensor data were collected and uploaded for AGP reporting. Complete data (sensor AGP with corresponding clinical information) were obtained for 50 patients with type 1 (70%) and type 2 diabetes (30%), irrespective of therapy. Aggregated analysis of AGP data comparing patients with type 1 versus type 2 diabetes, revealed that despite similar HbA1c values between both groups (8.4 ± 2 vs 8.6 ± 1.7%, respectively), those with type 2 diabetes had lower mean glucose levels (9.2 ± 3 vs 10.3 mmol/l [166 ± 54 vs 185 mg/dl]) and lower indices of glucose variability (3.0 ± 1.5 vs 5.0 ± 1.9 mmol/l [54 ± 27 vs 90 ± 34.2 mg/dl]). This highlights key areas for future focus. Using AGP, the characteristics of glucose exposure, variability, stability, and hypoglycemia risk and occurrence were obtained within a short time and with minimal provider and patient input. In a survey at the time of the follow-up visit, clinicians indicated that aggregated AGP data analysis provided important new clinical information and insights. © 2016 Diabetes Technology Society.

Quantification of topographic changes in the surface of back of young patients monitored for idiopathic scoliosis: correlation with radiographic variables

NASA Astrophysics Data System (ADS)

Pino-Almero, Laura; Mínguez-Rey, María Fe; Sentamans-Segarra, Salvador; Salvador-Palmer, María Rosario; Anda, Rosa María Cibrián-Ortiz de; La O, Javier López-de

2016-11-01

Idiopathic scoliosis requires a close follow-up while the patient is skeletally immature to detect early progression. Patients who are monitored by radiographs are exposed to high doses of ionizing radiation. The purpose of this study is to evaluate if an optic noninvasive method of back surface topography based on structured light would be clinically useful in the follow-up of young patients with idiopathic scoliosis. This could reduce the number of radiographs made on these children. Thirty-one patients with idiopathic scoliosis were submitted twice to radiograph and our topographic method at intervals of 6 months to 1 year. Three topographical variables were applied horizontal plane deformity index (DHOPI), posterior trunk symmetry index (POTSI), and columnar profile (PC). A statistically significant correlation was found between variations of Cobb angle with DHOPI (r=0.720, p<0.01) and POTSI (r=0.753, p<0.01) during the monitoring period. Hence, this topographic method could be useful in clinical practice as an objective adjuvant tool in routine follow-up of scoliosis.

Eight to 14 μm spectral monitoring of long period variable stars with GLADYS.

NASA Astrophysics Data System (ADS)

Levan, P. D.; Sloan, G.; Grasdalen, G.

The authors describe an ongoing program of spectral monitoring of long period variable stars using GLADYS, a long slit prism spectrometer that employs a 58x62 pixel Si:Ga detector array. The goal is to compare the equivalent widths of the SiC emission features in carbon-rich circumstellar shells, and the silicate emission features in oxygen-rich circumstellar stars, obtained over different phases of the continuum variability cycle. Spectra of long period variables and low amplitude variables recently obtained on the Wyoming Infrared Observatory 2.3 m telescope are presented.

Intra- and Interobserver Variability of Cochlear Length Measurements in Clinical CT.

PubMed

Iyaniwura, John E; Elfarnawany, Mai; Riyahi-Alam, Sadegh; Sharma, Manas; Kassam, Zahra; Bureau, Yves; Parnes, Lorne S; Ladak, Hanif M; Agrawal, Sumit K

2017-07-01

The cochlear A-value measurement exhibits significant inter- and intraobserver variability, and its accuracy is dependent on the visualization method in clinical computed tomography (CT) images of the cochlea. An accurate estimate of the cochlear duct length (CDL) can be used to determine electrode choice, and frequency map the cochlea based on the Greenwood equation. Studies have described estimating the CDL using a single A-value measurement, however the observer variability has not been assessed. Clinical and micro-CT images of 20 cadaveric cochleae were acquired. Four specialists measured A-values on clinical CT images using both standard views and multiplanar reconstructed (MPR) views. Measurements were repeated to assess for intraobserver variability. Observer variabilities were evaluated using intra-class correlation and absolute differences. Accuracy was evaluated by comparison to the gold standard micro-CT images of the same specimens. Interobserver variability was good (average absolute difference: 0.77 ± 0.42 mm) using standard views and fair (average absolute difference: 0.90 ± 0.31 mm) using MPR views. Intraobserver variability had an average absolute difference of 0.31 ± 0.09 mm for the standard views and 0.38 ± 0.17 mm for the MPR views. MPR view measurements were more accurate than standard views, with average relative errors of 9.5 and 14.5%, respectively. There was significant observer variability in A-value measurements using both the standard and MPR views. Creating the MPR views increased variability between experts, however MPR views yielded more accurate results. Automated A-value measurement algorithms may help to reduce variability and increase accuracy in the future.

[Patients' perspective and economic variables as objectives in clinical trials: added value to clinical parameters].

PubMed

Bovaira-García, M J; Soler-Company, E

2012-01-01

Patient-reported outcome (PRO) measures complement traditional biomedical outcome measures. The purpose of this study was to evaluate the use of PRO measures including health-related quality of life (HRQoL) questionnaires as a measurement of efficacy and the frequency of inclusion of economic variables related to direct and indirect costs in the design of clinical trials and phase IV observational studies. Moreover, for the trials quality score were measured, and if there were any relationship between the quality study design score and the PRO inclusion. Retrospective observational study of the clinical trials and phase IV observational studies approved by a Clinical Research Ethics Committee (2008-2010). We gathered data concerning general aspects including medical specialty, pathology, methodological quality based on Jadad scale (0-5), inclusion of PRO and economic variables. For clinical trials including HRQoL measurements, we analysed the type of questionnaire in use. Where there were no HRQoL measurements, we analysed if their inclusion would have been proper or not. A total of 70 protocols (59 CTs and 11 phase IV observational studies) were analysed; 37 (52.8%) included PRO measures, and 3 protocols (4.3%) used them as a primary endpoint. Data analysis by therapeutic area showed that PRO measures were most commonly studied in the fields of endocrinology, neurology, digestive diseases, and cardiology. The average quality score for the trials was 2.8. The trials with more PRO inclusion in their end points had a significantly higher quality score. Only 13 (22%) clinical trials and 2 (18.2%) phase IV observational studies included economic variables. The emergence of economic variables in clinical trials and phase IV observational studies evaluated was low, however, more than half of the revised protocols have included PRO measures, reflecting the importance of these parameters in the assessment of the effectiveness of drug treatments, although its use is still

Ultrasound monitoring of the treatment of clinically significant knee osteoarthritis.

PubMed

Vojtassak, J; Vojtassak, J

2014-01-01

The study presented an ultrasound (US) monitoring of treatment as a new imaging US method with the results of therapy of clinically significant knee osteoarthritis. X-ray is widely used for knee osteoarthritis classification, which does not involve the evaluation of the soft tissue. High frequency and high resolution US of joints (arthrosonography, echoarthrography) assess not only morphologic but also functional changes in the knee joint. In the prospective study, 110 patients with clinically significant knee osteoarthritis were treated non-operative. US examination and US monitoring of therapy was performed during 24 weeks therapy period. A remission of pathomorphologic (marginal osteofytes) and pathophysiologic (effusion in anterior knee and Baker´s cyst) attributes were evaluated according the US classification. Pathomorphologic attributes changes showed a static state, without remission or progression. Pathophysiologic attributes changes showed a remission during the study period. The highest remission was in the first three weeks, 60 % anterior knee effusion and 62 % Baker´s cyst. At the end of study, no changes from the initial US grade was observed in 16 % of effusion in anterior knee and 22 % of Baker´s cyst. Therapeutic resistant Baker´s cyst was present at the end of study in 36 %. We demonstrated a new method - US monitoring of therapy, which can objectivize the efficiency of treatment of clinically significant knee osteoarthritis. We would recommend US monitoring of therapy for the routine use in orthopedic clinical praxis (Tab. 6, Graph 3, Fig. 3, Ref. 15).

A Simple Composite Metric for the Assessment of Glycemic Status from Continuous Glucose Monitoring Data: Implications for Clinical Practice and the Artificial Pancreas.

PubMed

Hirsch, Irl B; Balo, Andrew K; Sayer, Kevin; Garcia, Arturo; Buckingham, Bruce A; Peyser, Thomas A

2017-06-01

The potential clinical benefits of continuous glucose monitoring (CGM) have been recognized for many years, but CGM is used by a small fraction of patients with diabetes. One obstacle to greater use of the technology is the lack of simplified tools for assessing glycemic control from CGM data without complicated visual displays of data. We developed a simple new metric, the personal glycemic state (PGS), to assess glycemic control solely from continuous glucose monitoring data. PGS is a composite index that assesses four domains of glycemic control: mean glucose, glycemic variability, time in range and frequency and severity of hypoglycemia. The metric was applied to data from six clinical studies for the G4 Platinum continuous glucose monitoring system (Dexcom, San Diego, CA). The PGS was also applied to data from a study of artificial pancreas comparing results from open loop and closed loop in adolescents and in adults. The new metric for glycemic control, PGS, was able to characterize the quality of glycemic control in a wide range of study subjects with various mean glucose, minimal, moderate, and excessive glycemic variability and subjects on open loop versus closed loop control. A new composite metric for the assessment of glycemic control based on CGM data has been defined for use in assessing glycemic control in clinical practice and research settings. The new metric may help rapidly identify problems in glycemic control and may assist with optimizing diabetes therapy during time-constrained physician office visits.

Whole Body Magnetic Resonance Imaging Features in Diffuse Idiopathic Skeletal Hyperostosis in Conjunction with Clinical Variables to Whole Body MRI and Clinical Variables in Ankylosing Spondylitis.

PubMed

Weiss, Bettina G; Bachmann, Lucas M; Pfirrmann, Christian W A; Kissling, Rudolf O; Zubler, Veronika

2016-02-01

Discrimination of diffuse idiopathic skeletal hyperostosis (DISH) and ankylosing spondylitis (AS) can be challenging. Usefulness of whole-body magnetic resonance imaging (WB-MRI) in diagnosing spondyloarthritis has been recently proved. We assessed the value of clinical variables alone and in combination with WB-MRI to distinguish between DISH and AS. Diagnostic case-control study: 33 patients with AS and 15 patients with DISH were included. All patients underwent 1.5 Tesla WB-MRI scanning. MR scans were read by a blinded radiologist using the Canadian-Danish Working Group's recommendation. Imaging and clinical variables were identified using the bootstrap. The most important variables from MR and clinical history were assessed in a multivariate fashion resulting in 3 diagnostic models (MRI, clinical, and combined). The discriminative capacity was quantified using the area under the receiver-operating characteristic (ROC) curve. The strength of diagnostic variables was quantified with OR. Forty-eight patients provided 1545 positive findings (193 DISH/1352 AS). The final MR model contained upper anterior corner fat infiltration (32 DISH/181 AS), ankylosis on the vertebral endplate (4 DISH/60 AS), facet joint ankylosis (4 DISH/49 AS), sacroiliac joint edema (11 DISH/91 AS), sacroiliac joint fat infiltration (2 DISH/114 AS), sacroiliac joint ankylosis (2 DISH/119 AS); area under the ROC curve was 0.71, 95% CI 0.64-0.78. The final clinical model contained patient's age and body mass index (area under the ROC curve 0.90, 95% CI 0.89-0.91). The full diagnostic model containing clinical and MR information had an area under the ROC curve of 0.93 (95% CI 0.92-0.95). WB-MRI features can contribute to the correct diagnosis after a thorough conventional workup of patients with DISH and AS.

Students, Teachers, and Schools as Sources of Variability, Integrity, and Sustainability in Implementing Progress Monitoring

ERIC Educational Resources Information Center

Bolt, Daniel M.; Ysseldyke, Jim; Patterson, Michael J.

2010-01-01

A three-level variance decomposition analysis was used to examine the sources of variability in implementation of a technology-enhanced progress monitoring system within each year of a 2-year study using a randomized-controlled design. We show that results of technology-enhanced progress monitoring are not necessarily a measure of student…

On assessing the quality of physicians' clinical judgment: the search for outcome variables.

PubMed

Wainer, Howard; Mee, Janet

2004-12-01

A primary question that must be resolved in the development of tasks to assess the quality of physicians' clinical judgment is, "What is the outcome variable?" One natural choice would seem to be the correctness of the clinical decision. In this article, we use data on the diagnosis of urinary tract infections among young girls to illustrate why, in many clinical situations, this is not a useful variable. We propose instead a judgment weighted by the relative costs of an error. This variable has the disadvantage of requiring expert judgment for scoring, but the advantage of measuring the construct of interest.

Monitor Variability of Millimeter Lines in IRC+10216

NASA Astrophysics Data System (ADS)

He, J. H.; Dinh-V-Trung; Hasegawa, T. I.

2017-08-01

A single dish monitoring of millimeter maser lines SiS J = 14-13 and HCN {ν }2={1}f J = 3-2 and several other rotational lines is reported for the archetypal carbon star IRC+10216. Relative line strength variations of 5% ∼ 30% are found for eight molecular line features with respect to selected reference lines. Definite line-shape variations are found in limited velocity intervals of the SiS and HCN line profiles. The asymmetrical line profiles of the two lines are mainly due to the varying components. The dominant varying components of the line profiles have similar periods and phases to the IR light variation, though both quantities show some degree of velocity dependence; there is also variability asymmetry between the blue and red line wings of both lines. Combining the velocities and amplitudes with a wind velocity model, we suggest that the line profile variations are due to SiS and HCN masing lines emanating from the wind acceleration zone. The possible link of the variabilities to thermal, dynamical, and/or chemical processes within or under this region is also discussed.

Canine Angiostrongylosis in Naturally Infected Dogs: Clinical Approach and Monitoring of Infection after Treatment

PubMed Central

Capogna, Antonio; Lia, Riccardo Paolo; Sasanelli, Mariateresa

2013-01-01

Canine angiostrongylosis is an increasingly reported disease in Europe which can be fatal if left untreated. The wide range of clinical presentation along with the absence of pathognomonic alterations can make the diagnosis challenging; thus any additional information that may provide clues to an early diagnosis may be of value, in order to ensure adequate anthelmintic treatment. Aim of the study was to assess a clinicopathological scoring system associated with natural Angiostrongylus vasorum infection diagnosed in canine patients during clinical practice, to clinically and paraclinically monitor infected dogs after treatment, and to monitor the presence of L1 larvae in faecal samples by Baermann's test. Of the total 210 enrolled animals A. vasorum infection was diagnosed in 7 dogs. These dogs were clinically and paraclinically investigated and monitored after specific treatment. Further 3 symptomatic dogs were retrospectively included in the monitoring. Results suggest that the computed scoring system can help to increase the clinical suspicion of infection particularly in asymptomatic dogs before the onset of potentially lethal lesions. Data of faecal monitoring suggested that treatment may control parasite burden but be unable to eradicate infection. Thus, a continued faecal monitoring after treatment is advisable for identification of still infected or reinfected dogs. PMID:24459443

Real time monitoring of risk-adjusted paediatric cardiac surgery outcomes using variable life-adjusted display: implementation in three UK centres

PubMed Central

Pagel, Christina; Utley, Martin; Crowe, Sonya; Witter, Thomas; Anderson, David; Samson, Ray; McLean, Andrew; Banks, Victoria; Tsang, Victor; Brown, Katherine

2013-01-01

Objective To implement routine in-house monitoring of risk-adjusted 30-day mortality following paediatric cardiac surgery. Design Collaborative monitoring software development and implementation in three specialist centres. Patients and methods Analyses incorporated 2 years of data routinely audited by the National Institute of Cardiac Outcomes Research (NICOR). Exclusion criteria were patients over 16 or undergoing non-cardiac or only catheter procedures. We applied the partial risk adjustment in surgery (PRAiS) risk model for death within 30 days following surgery and generated variable life-adjusted display (VLAD) charts for each centre. These were shared with each clinical team and feedback was sought. Results Participating centres were Great Ormond Street Hospital, Evelina Children's Hospital and The Royal Hospital for Sick Children in Glasgow. Data captured all procedures performed between 1 January 2010 and 31 December 2011. This incorporated 2490 30-day episodes of care, 66 of which were associated with a death within 30 days.The VLAD charts generated for each centre displayed trends in outcomes benchmarked to recent national outcomes. All centres ended the 2-year period within four deaths from what would be expected. The VLAD charts were shared in multidisciplinary meetings and clinical teams reported that they were a useful addition to existing quality assurance initiatives. Each centre is continuing to use the prototype software to monitor their in-house surgical outcomes. Conclusions Timely and routine monitoring of risk-adjusted mortality following paediatric cardiac surgery is feasible. Close liaison with hospital data managers as well as clinicians was crucial to the success of the project. PMID:23564473

Automated size-specific CT dose monitoring program: assessing variability in CT dose.

PubMed

Christianson, Olav; Li, Xiang; Frush, Donald; Samei, Ehsan

2012-11-01

The potential health risks associated with low levels of ionizing radiation have created a movement in the radiology community to optimize computed tomography (CT) imaging protocols to use the lowest radiation dose possible without compromising the diagnostic usefulness of the images. Despite efforts to use appropriate and consistent radiation doses, studies suggest that a great deal of variability in radiation dose exists both within and between institutions for CT imaging. In this context, the authors have developed an automated size-specific radiation dose monitoring program for CT and used this program to assess variability in size-adjusted effective dose from CT imaging. The authors radiation dose monitoring program operates on an independent health insurance portability and accountability act compliant dosimetry server. Digital imaging and communication in medicine routing software is used to isolate dose report screen captures and scout images for all incoming CT studies. Effective dose conversion factors (k-factors) are determined based on the protocol and optical character recognition is used to extract the CT dose index and dose-length product. The patient's thickness is obtained by applying an adaptive thresholding algorithm to the scout images and is used to calculate the size-adjusted effective dose (ED(adj)). The radiation dose monitoring program was used to collect data on 6351 CT studies from three scanner models (GE Lightspeed Pro 16, GE Lightspeed VCT, and GE Definition CT750 HD) and two institutions over a one-month period and to analyze the variability in ED(adj) between scanner models and across institutions. No significant difference was found between computer measurements of patient thickness and observer measurements (p = 0.17), and the average difference between the two methods was less than 4%. Applying the size correction resulted in ED(adj) that differed by up to 44% from effective dose estimates that were not adjusted by patient size

Using Mobile Monitoring to Assess Spatial Variability in Urban Air Pollution Levels: Opportunities and Challenges (Invited)

NASA Astrophysics Data System (ADS)

Larson, T.

2010-12-01

Measuring air pollution concentrations from a moving platform is not a new idea. Historically, however, most information on the spatial variability of air pollutants have been derived from fixed site networks operating simultaneously over space. While this approach has obvious advantages from a regulatory perspective, with the increasing need to understand ever finer scales of spatial variability in urban pollution levels, the use of mobile monitoring to supplement fixed site networks has received increasing attention. Here we present examples of the use of this approach: 1) to assess existing fixed-site fine particle networks in Seattle, WA, including the establishment of new fixed-site monitoring locations; 2) to assess the effectiveness of a regulatory intervention, a wood stove burning ban, on the reduction of fine particle levels in the greater Puget Sound region; and 3) to assess spatial variability of both wood smoke and mobile source impacts in both Vancouver, B.C. and Tacoma, WA. Deducing spatial information from the inherently spatio-temporal measurements taken from a mobile platform is an area that deserves further attention. We discuss the use of “fuzzy” points to address the fine-scale spatio-temporal variability in the concentration of mobile source pollutants, specifically to deduce the broader distribution and sources of fine particle soot in the summer in Vancouver, B.C. We also discuss the use of principal component analysis to assess the spatial variability in multivariate, source-related features deduced from simultaneous measurements of light scattering, light absorption and particle-bound PAHs in Tacoma, WA. With increasing miniaturization and decreasing power requirements of air monitoring instruments, the number of simultaneous measurements that can easily be made from a mobile platform is rapidly increasing. Hopefully the methods used to design mobile monitoring experiments for differing purposes, and the methods used to interpret those

Global biodiversity monitoring: from data sources to essential biodiversity variables

USGS Publications Warehouse

Proenca, Vania; Martin, Laura J.; Pereira, Henrique M.; Fernandez, Miguel; McRae, Louise; Belnap, Jayne; Böhm, Monika; Brummitt, Neil; Garcia-Moreno, Jaime; Gregory, Richard D.; Honrado, Joao P; Jürgens, Norbert; Opige, Michael; Schmeller, Dirk S.; Tiago, Patricia; van Sway, Chris A

2016-01-01

Essential Biodiversity Variables (EBVs) consolidate information from varied biodiversity observation sources. Here we demonstrate the links between data sources, EBVs and indicators and discuss how different sources of biodiversity observations can be harnessed to inform EBVs. We classify sources of primary observations into four types: extensive and intensive monitoring schemes, ecological field studies and satellite remote sensing. We characterize their geographic, taxonomic and temporal coverage. Ecological field studies and intensive monitoring schemes inform a wide range of EBVs, but the former tend to deliver short-term data, while the geographic coverage of the latter is limited. In contrast, extensive monitoring schemes mostly inform the population abundance EBV, but deliver long-term data across an extensive network of sites. Satellite remote sensing is particularly suited to providing information on ecosystem function and structure EBVs. Biases behind data sources may affect the representativeness of global biodiversity datasets. To improve them, researchers must assess data sources and then develop strategies to compensate for identified gaps. We draw on the population abundance dataset informing the Living Planet Index (LPI) to illustrate the effects of data sources on EBV representativeness. We find that long-term monitoring schemes informing the LPI are still scarce outside of Europe and North America and that ecological field studies play a key role in covering that gap. Achieving representative EBV datasets will depend both on the ability to integrate available data, through data harmonization and modeling efforts, and on the establishment of new monitoring programs to address critical data gaps.

An innovative statistical approach for analysing non-continuous variables in environmental monitoring: assessing temporal trends of TBT pollution.

PubMed

Santos, José António; Galante-Oliveira, Susana; Barroso, Carlos

2011-03-01

The current work presents an innovative statistical approach to model ordinal variables in environmental monitoring studies. An ordinal variable has values that can only be compared as "less", "equal" or "greater" and it is not possible to have information about the size of the difference between two particular values. The example of ordinal variable under this study is the vas deferens sequence (VDS) used in imposex (superimposition of male sexual characters onto prosobranch females) field assessment programmes for monitoring tributyltin (TBT) pollution. The statistical methodology presented here is the ordered logit regression model. It assumes that the VDS is an ordinal variable whose values match up a process of imposex development that can be considered continuous in both biological and statistical senses and can be described by a latent non-observable continuous variable. This model was applied to the case study of Nucella lapillus imposex monitoring surveys conducted in the Portuguese coast between 2003 and 2008 to evaluate the temporal evolution of TBT pollution in this country. In order to produce more reliable conclusions, the proposed model includes covariates that may influence the imposex response besides TBT (e.g. the shell size). The model also provides an analysis of the environmental risk associated to TBT pollution by estimating the probability of the occurrence of females with VDS ≥ 2 in each year, according to OSPAR criteria. We consider that the proposed application of this statistical methodology has a great potential in environmental monitoring whenever there is the need to model variables that can only be assessed through an ordinal scale of values.

Clinical application of pulse transit time and correlation with intrapartum fetal heart rate monitoring: a preliminary study of 18 full-term infants.

PubMed

Kawagoe, Yasuyuki; Sameshima, Hiroshi; Ikenoue, Tsuyomu

2008-07-01

The authors show that pulse transit time and blood pressure are reciprocal in fetal goat models. They applied this technique in clinical settings to correlate changes in pulse transit time with fetal heart rate monitoring patterns and acid-base status. In 18 uncomplicated pregnancies, pulse transit time was obtained from electrocardiograms to pulse oximeter waveform and averaged during each baseline period, defined by the interpretation of fetal heart rate monitoring. According to a > 10% change from the control value, chronological changes were categorized into shortened, unchanged, and prolonged. Pulse transit time was available in 82% +/- 11% of the recordings. In 15 fetuses, 2 (13%) showed prolonged, 7 (47%) showed shortened, and 6 (40%) showed unchanged conditions. Comparisons of the shortened and unchanged categories revealed that severe variable deceleration was significantly increased, and half or more fetuses showed hypoxemia in the shortened category. Shortening of pulse transit time, theoretically indicating a hypertensive condition, was more frequently associated with severe variable decelerations, suggesting that the pulse transit time may supplement the interpretation of fetal heart rate monitoring.

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study

PubMed Central

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-01-01

Objectives Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. Setting The setting for this research was a major academic institution in Beijing, China. Participants The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Methods Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Results Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. Conclusion These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate

Sentence comprehension in agrammatic aphasia: history and variability to clinical implications.

PubMed

Johnson, Danielle; Cannizzaro, Michael S

2009-01-01

Individuals with Broca's aphasia often present with deficits in their ability to comprehend non-canonical sentences. This has been contrastingly characterized as a systematic loss of specific grammatical abilities or as individual variability in the dynamics between processing load and resource availability. The present study investigated sentence level comprehension in participants with Broca's aphasia in an attempt to integrate these contrasting views into a clinically useful process. Two participants diagnosed with Broca's aphasia were assessed using a sentence-to-picture matching paradigm and a truth-value judgement task, across sentence constructions thought to be problematic for this population. The data demonstrate markedly different patterns of performance between participants, as well as variability within participants (e.g. by sentence type). These findings support the notion of individual performance variability in persons with aphasia. Syntactic theory was instructive for assessing sentence level comprehension, leading to a clinically relevant process of identifying treatment targets considering both performance variability and syntactic complexity for this population.

Technological advances in perioperative monitoring: Current concepts and clinical perspectives

PubMed Central

Chilkoti, Geetanjali; Wadhwa, Rachna; Saxena, Ashok Kumar

2015-01-01

Minimal mandatory monitoring in the perioperative period recommended by Association of Anesthetists of Great Britain and Ireland and American Society of Anesthesiologists are universally acknowledged and has become an integral part of the anesthesia practice. The technologies in perioperative monitoring have advanced, and the availability and clinical applications have multiplied exponentially. Newer monitoring techniques include depth of anesthesia monitoring, goal-directed fluid therapy, transesophageal echocardiography, advanced neurological monitoring, improved alarm system and technological advancement in objective pain assessment. Various factors that need to be considered with the use of improved monitoring techniques are their validation data, patient outcome, safety profile, cost-effectiveness, awareness of the possible adverse events, knowledge of technical principle and ability of the convenient routine handling. In this review, we will discuss the new monitoring techniques in anesthesia, their advantages, deficiencies, limitations, their comparison to the conventional methods and their effect on patient outcome, if any. PMID:25788767

Technological advances in perioperative monitoring: Current concepts and clinical perspectives.

PubMed

Chilkoti, Geetanjali; Wadhwa, Rachna; Saxena, Ashok Kumar

2015-01-01

Minimal mandatory monitoring in the perioperative period recommended by Association of Anesthetists of Great Britain and Ireland and American Society of Anesthesiologists are universally acknowledged and has become an integral part of the anesthesia practice. The technologies in perioperative monitoring have advanced, and the availability and clinical applications have multiplied exponentially. Newer monitoring techniques include depth of anesthesia monitoring, goal-directed fluid therapy, transesophageal echocardiography, advanced neurological monitoring, improved alarm system and technological advancement in objective pain assessment. Various factors that need to be considered with the use of improved monitoring techniques are their validation data, patient outcome, safety profile, cost-effectiveness, awareness of the possible adverse events, knowledge of technical principle and ability of the convenient routine handling. In this review, we will discuss the new monitoring techniques in anesthesia, their advantages, deficiencies, limitations, their comparison to the conventional methods and their effect on patient outcome, if any.

Dealing with incomplete and variable detectability in multi-year, multi-site monitoring of ecological populations

USGS Publications Warehouse

Converse, Sarah J.; Royle, J. Andrew; Gitzen, Robert A.; Millspaugh, Joshua J.; Cooper, Andrew B.; Licht, Daniel S.

2012-01-01

An ecological monitoring program should be viewed as a component of a larger framework designed to advance science and/or management, rather than as a stand-alone activity. Monitoring targets (the ecological variables of interest; e.g. abundance or occurrence of a species) should be set based on the needs of that framework (Nichols and Williams 2006; e.g. Chapters 2–4). Once such monitoring targets are set, the subsequent step in monitoring design involves consideration of the field and analytical methods that will be used to measure monitoring targets with adequate accuracy and precision. Long-term monitoring programs will involve replication of measurements over time, and possibly over space; that is, one location or each of multiple locations will be monitored multiple times, producing a collection of site visits (replicates). Clearly this replication is important for addressing spatial and temporal variability in the ecological resources of interest (Chapters 7–10), but it is worth considering how this replication can further be exploited to increase the effectiveness of monitoring. In particular, defensible monitoring of the majority of animal, and to a lesser degree plant, populations and communities will generally require investigators to account for imperfect detection (Chapters 4, 18). Raw indices of population state variables, such as abundance or occupancy (sensu MacKenzie et al. 2002), are rarely defensible when detection probabilities are < 1, because in those cases detection may vary over time and space in unpredictable ways. Myriad authors have discussed the risks inherent in making inference from monitoring data while failing to correct for differences in detection, resulting in indices that have an unknown relationship to the parameters of interest (e.g. Nichols 1992, Anderson 2001, MacKenzie et al. 2002, Williams et al. 2002, Anderson 2003, White 2005, Kéry and Schmidt 2008). While others have argued that indices may be preferable in some

When to trust our learners? Clinical teachers' perceptions of decision variables in the entrustment process.

PubMed

Duijn, Chantal C M A; Welink, Lisanne S; Bok, Harold G J; Ten Cate, Olle T J

2018-06-01

Clinical training programs increasingly use entrustable professional activities (EPAs) as focus of assessment. However, questions remain about which information should ground decisions to trust learners. This qualitative study aimed to identify decision variables in the workplace that clinical teachers find relevant in the elaboration of the entrustment decision processes. The findings can substantiate entrustment decision-making in the clinical workplace. Focus groups were conducted with medical and veterinary clinical teachers, using the structured consensus method of the Nominal Group Technique to generate decision variables. A ranking was made based on a relevance score assigned by the clinical teachers to the different decision variables. Field notes, audio recordings and flip chart lists were analyzed and subsequently translated and, as a form of axial coding, merged into one list, combining the decision variables that were similar in their meaning. A list of 11 and 17 decision variables were acknowledged as relevant by the medical and veterinary teacher groups, respectively. The focus groups yielded 21 unique decision variables that were considered relevant to inform readiness to perform a clinical task on a designated level of supervision. The decision variables consisted of skills, generic qualities, characteristics, previous performance or other information. We were able to group the decision variables into five categories: ability, humility, integrity, reliability and adequate exposure. To entrust a learner to perform a task at a specific level of supervision, a supervisor needs information to support such a judgement. This trust cannot be credited on a single case at a single moment of assessment, but requires different variables and multiple sources of information. This study provides an overview of decision variables giving evidence to justify the multifactorial process of making an entrustment decision.

Prediction of remission of depression with clinical variables, neuropsychological performance, and serotonergic/dopaminergic gene polymorphisms.

PubMed

Gudayol-Ferré, Esteve; Herrera-Guzmán, Ixchel; Camarena, Beatriz; Cortés-Penagos, Carlos; Herrera-Abarca, Jorge E; Martínez-Medina, Patricia; Asbun-Bojalil, Juan; Lira-Islas, Yuridia; Reyes-Ponce, Celia; Guàrdia-Olmos, Joan

2012-11-01

The aim of our work is to study the possible role of clinical variables, neuropsychological performance, and the 5HTTLPR, rs25531, and val108/58Met COMT polymorphisms on the prediction of depression remission after 12 weeks' treatment with fluoxetine. These variables have been studied as potential predictors of depression remission, but they present poor prognostic sensitivity and specificity by themselves. Seventy-two depressed patients were genotyped according to the aforementioned polymorphisms and were clinically and neuropsychologically assessed before a 12-week fluxetine treatment. Only the La allele of rs25531 polymorphism and the GG and AA forms of the val 108/158 Met polymorphism predict major depressive disorder remission after 12 weeks' treatment with fluoxetine. None of the clinical and neuropsychological variables studied predicted remission. Our results suggest that clinical and neuropsychological variables can initially predict early response to fluoxetine and mask the predictive role of genetic variables; but in remission, where clinical and neuropsychological symptoms associated with depression tend to disappear thanks to the treatment administered, the polymorphisms studied are the only variables in our model capable of predicting remission. However, placebo effects that are difficult to control require cautious interpretation of the results.

Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an implantable monitoring system.

PubMed

Adamson, Philip B; Magalski, Anthony; Braunschweig, Frieder; Böhm, Michael; Reynolds, Dwight; Steinhaus, David; Luby, Allyson; Linde, Cecilia; Ryden, Lars; Cremers, Bodo; Takle, Teri; Bennett, Tom

2003-02-19

This study examined the characteristics of continuously measured right ventricular (RV) hemodynamic information derived from an implantable hemodynamic monitor (IHM) in heart failure patients. Hemodynamic monitoring might improve the day-to-day management of patients with chronic heart failure (CHF). Little is known about the characteristics of long-term hemodynamic information in patients with CHF or how such information relates to meaningful clinical events. Thirty-two patients with CHF received a permanent RV IHM system similar to a single-lead pacemaker. Right ventricular systolic and diastolic pressures, heart rate, and pressure derivatives were continuously measured for nine months without using the data for clinical decision-making or management of patients. Data were then made available to clinical providers, and the patients were followed up for 17 months. Pressure characteristics during optimal volume, clinically determined volume-overload exacerbations, and volume depletion events were examined. The effect of IHM on hospitalizations was examined using the patients' historical controls. Long-term RV pressure measurements had either marked variability or minimal time-related changes. During 36 volume-overload events, RV systolic pressures increased by 25 +/- 4% (p < 0.05) and heart rate increased by 11 +/- 2% (p < 0.05). Pressure increases occurred in 9 of 12 events 4 +/- 2 days before the exacerbations requiring hospitalization. Hospitalizations before using IHM data for clinical management averaged 1.08 per patient year and decreased to 0.47 per patient-year (57% reduction, p < 0.01) after hemodynamic data were used. Long-term ambulatory pressure measurements from an IHM may be helpful in guiding day-to-day clinical management, with a potentially favorable impact on CHF hospitalizations.

Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.

PubMed

Crossley, George H; Chen, Jane; Choucair, Wassim; Cohen, Todd J; Gohn, Douglas C; Johnson, W Ben; Kennedy, Eleanor E; Mongeon, Luc R; Serwer, Gerald A; Qiao, Hongyan; Wilkoff, Bruce L

2009-11-24

The purpose of this study was to evaluate remote pacemaker interrogation for the earlier diagnosis of clinically actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation. Pacemaker patient follow-up procedures have evolved from evaluating devices with little programmability and diagnostic information solely in person to transtelephonic rhythm strip recordings that allow monitoring of basic device function. More recently developed remote monitoring technology leverages expanded device capabilities, augmenting traditional transtelephonic monitoring to evaluate patients via full device interrogation. The time to first diagnosis of a clinically actionable event was compared in patients who were followed by remote interrogation (Remote) and those who were followed per standard of care with office visits augmented by transtelephonic monitoring (Control). Patients were randomized 2:1. Remote arm patients transmitted pacemaker information at 3-month intervals. Control arm patients with a single-chamber pacemaker transmitted at 2-month intervals. Control arm patients with dual-chamber devices transmitted at 2-month intervals with an office visit at 6 months. All patients were seen in office at 12 months. The mean time to first diagnosis of clinically actionable events was earlier in the Remote arm (5.7 months) than in the Control arm (7.7 months). Three (2%) of the 190 events in the Control arm and 446 (66%) of 676 events in the Remote arm were identified remotely. The strategic use of remote pacemaker interrogation follow-up detects actionable events that are potentially important more quickly and more frequently than transtelephonic rhythm strip recordings. The use of transtelephonic rhythm strips for pacemaker follow-up is of little value except for battery status determinations. (PREFER [Pacemaker Remote Follow-up Evaluation and Review]; NCT00294645).

The balanced mind: the variability of task-unrelated thoughts predicts error monitoring

PubMed Central

Allen, Micah; Smallwood, Jonathan; Christensen, Joanna; Gramm, Daniel; Rasmussen, Beinta; Jensen, Christian Gaden; Roepstorff, Andreas; Lutz, Antoine

2013-01-01

Self-generated thoughts unrelated to ongoing activities, also known as “mind-wandering,” make up a substantial portion of our daily lives. Reports of such task-unrelated thoughts (TUTs) predict both poor performance on demanding cognitive tasks and blood-oxygen-level-dependent (BOLD) activity in the default mode network (DMN). However, recent findings suggest that TUTs and the DMN can also facilitate metacognitive abilities and related behaviors. To further understand these relationships, we examined the influence of subjective intensity, ruminative quality, and variability of mind-wandering on response inhibition and monitoring, using the Error Awareness Task (EAT). We expected to replicate links between TUT and reduced inhibition, and explored whether variance in TUT would predict improved error monitoring, reflecting a capacity to balance between internal and external cognition. By analyzing BOLD responses to subjective probes and the EAT, we dissociated contributions of the DMN, executive, and salience networks to task performance. While both response inhibition and online TUT ratings modulated BOLD activity in the medial prefrontal cortex (mPFC) of the DMN, the former recruited a more dorsal area implying functional segregation. We further found that individual differences in mean TUTs strongly predicted EAT stop accuracy, while TUT variability specifically predicted levels of error awareness. Interestingly, we also observed co-activation of salience and default mode regions during error awareness, supporting a link between monitoring and TUTs. Altogether our results suggest that although TUT is detrimental to task performance, fluctuations in attention between self-generated and external task-related thought is a characteristic of individuals with greater metacognitive monitoring capacity. Achieving a balance between internally and externally oriented thought may thus aid individuals in optimizing their task performance. PMID:24223545

A review on therapeutic drug monitoring of immunosuppressant drugs.

PubMed

Mohammadpour, Niloufar; Elyasi, Sepideh; Vahdati, Naser; Mohammadpour, Amir Hooshang; Shamsara, Jamal

2011-11-01

: Immunosuppressants require therapeutic drug monitoring because of their narrow therapeutic index and significant inter-individual variability in blood concentrations. This variability can be because of factors like drug-nutrient interactions, drug-disease interactions, renal-insufficiency, inflammation and infection, gender, age, polymorphism and liver mass. Drug monitoring is widely practiced especially for cyclosporine, tacrolimus, sirolimus and mycophenolic acid. CYCLOSPORINE: Therapeutic monitoring of immunosuppressive therapy with cyclosporine is a critical requirement because of intra- and inter-patient variability of drug absorption, narrow therapeutic window and drug induced nephrotoxicity. MYCOPHENOLIC ACID MPA: Some reasons for therapeutic drug monitoring of MPA during post-transplant period include: relationship between MPA pharmacokinetic parameters and clinical outcomes, Inter-patient pharmacokinetic variability for MPA despite fixed MMF doses, alternations of MPA pharmacokinetics during the first months after transplantation, drug- drug interaction and influence of kidney function on MPA pharmacokinetic. SIROLIMUS: A recent review of the pharmacokinetics of sirolimus suggested a therapeutic range of 5 to 10 μg l(-1) in whole blood. However, the only consensus guidelines published on the therapeutic monitoring of sirolimus concluded that there was not enough information available about the clinical use of the drug to make recommendations. TACROLIMUS: Sudies have shown, in kidney and liver transplant patients, significant associations of low tacrolimus concentrations with rejection and of high concentrations with nephrotoxicity. Although the feasibility of a limited sampling scheme to predict AUC has been demonstrated, as yet, trough, or pre-dose, whole blood concentration monitoring is still the method of choice.

Automated size-specific CT dose monitoring program: Assessing variability in CT dose

DOE Office of Scientific and Technical Information (OSTI.GOV)

Christianson, Olav; Li Xiang; Frush, Donald

2012-11-15

Purpose: The potential health risks associated with low levels of ionizing radiation have created a movement in the radiology community to optimize computed tomography (CT) imaging protocols to use the lowest radiation dose possible without compromising the diagnostic usefulness of the images. Despite efforts to use appropriate and consistent radiation doses, studies suggest that a great deal of variability in radiation dose exists both within and between institutions for CT imaging. In this context, the authors have developed an automated size-specific radiation dose monitoring program for CT and used this program to assess variability in size-adjusted effective dose from CTmore » imaging. Methods: The authors radiation dose monitoring program operates on an independent health insurance portability and accountability act compliant dosimetry server. Digital imaging and communication in medicine routing software is used to isolate dose report screen captures and scout images for all incoming CT studies. Effective dose conversion factors (k-factors) are determined based on the protocol and optical character recognition is used to extract the CT dose index and dose-length product. The patient's thickness is obtained by applying an adaptive thresholding algorithm to the scout images and is used to calculate the size-adjusted effective dose (ED{sub adj}). The radiation dose monitoring program was used to collect data on 6351 CT studies from three scanner models (GE Lightspeed Pro 16, GE Lightspeed VCT, and GE Definition CT750 HD) and two institutions over a one-month period and to analyze the variability in ED{sub adj} between scanner models and across institutions. Results: No significant difference was found between computer measurements of patient thickness and observer measurements (p= 0.17), and the average difference between the two methods was less than 4%. Applying the size correction resulted in ED{sub adj} that differed by up to 44% from effective dose

Monitoring clinical standards in a chronic peritoneal dialysis program.

PubMed

Leung, Dora K C

2009-02-01

Multiple factors may influence the effectiveness of a chronic peritoneal dialysis program. Continuous monitoring of various aspects of clinical standards with reviews enhances opportunities for bridging the gap between existing practice and good practice, and good practice to best practice.

Process monitoring using automatic physical measurement based on electrical and physical variability analysis

NASA Astrophysics Data System (ADS)

Shauly, Eitan N.; Levi, Shimon; Schwarzband, Ishai; Adan, Ofer; Latinsky, Sergey

2015-04-01

A fully automated silicon-based methodology for systematic analysis of electrical features is shown. The system was developed for process monitoring and electrical variability reduction. A mapping step was created by dedicated structures such as static-random-access-memory (SRAM) array or standard cell library, or by using a simple design rule checking run-set. The resulting database was then used as an input for choosing locations for critical dimension scanning electron microscope images and for specific layout parameter extraction then was input to SPICE compact modeling simulation. Based on the experimental data, we identified two items that must be checked and monitored using the method described here: transistor's sensitivity to the distance between the poly end cap and edge of active area (AA) due to AA rounding, and SRAM leakage due to a too close N-well to P-well. Based on this example, for process monitoring and variability analyses, we extensively used this method to analyze transistor gates having different shapes. In addition, analysis for a large area of high density standard cell library was done. Another set of monitoring focused on a high density SRAM array is also presented. These examples provided information on the poly and AA layers, using transistor parameters such as leakage current and drive current. We successfully define "robust" and "less-robust" transistor configurations included in the library and identified unsymmetrical transistors in the SRAM bit-cells. These data were compared to data extracted from the same devices at the end of the line. Another set of analyses was done to samples after Cu M1 etch. Process monitoring information on M1 enclosed contact was extracted based on contact resistance as a feedback. Guidelines for the optimal M1 space for different layout configurations were also extracted. All these data showed the successful in-field implementation of our methodology as a useful process monitoring method.

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

PubMed

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-09-18

Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

Clinical Trials With Large Numbers of Variables: Important Advantages of Canonical Analysis.

PubMed

Cleophas, Ton J

2016-01-01

Canonical analysis assesses the combined effects of a set of predictor variables on a set of outcome variables, but it is little used in clinical trials despite the omnipresence of multiple variables. The aim of this study was to assess the performance of canonical analysis as compared with traditional multivariate methods using multivariate analysis of covariance (MANCOVA). As an example, a simulated data file with 12 gene expression levels and 4 drug efficacy scores was used. The correlation coefficient between the 12 predictor and 4 outcome variables was 0.87 (P = 0.0001) meaning that 76% of the variability in the outcome variables was explained by the 12 covariates. Repeated testing after the removal of 5 unimportant predictor and 1 outcome variable produced virtually the same overall result. The MANCOVA identified identical unimportant variables, but it was unable to provide overall statistics. (1) Canonical analysis is remarkable, because it can handle many more variables than traditional multivariate methods such as MANCOVA can. (2) At the same time, it accounts for the relative importance of the separate variables, their interactions and differences in units. (3) Canonical analysis provides overall statistics of the effects of sets of variables, whereas traditional multivariate methods only provide the statistics of the separate variables. (4) Unlike other methods for combining the effects of multiple variables such as factor analysis/partial least squares, canonical analysis is scientifically entirely rigorous. (5) Limitations include that it is less flexible than factor analysis/partial least squares, because only 2 sets of variables are used and because multiple solutions instead of one is offered. We do hope that this article will stimulate clinical investigators to start using this remarkable method.

The Paradox of Pelvic Exenteration: The Interaction of Clinical and Psychological Variables.

PubMed

Arnaboldi, Paola; Santoro, Luigi; Mazzocco, Ketti; Oliveri, Serena; Maggioni, Angelo; Pravettoni, Gabriella

2015-10-01

To text the feasibility of a psychological intervention package administered to 49 pelvic exenteration candidates, aimed at evaluating the preoperative prevalence of psychological distress and assessing the presence of any correlation between preoperative psychological distress and clinical variables such as pain and hospitalization length. Patients were referred to the psychology unit from the very beginning of their clinical pathway and were administered the Psychological Distress Inventory (PDI) and the Mini-Mental Adjustment to Cancer (Mini-MAC) questionnaire at prehospital admission. Patients presenting with a significant level of distress received nonstandardized psychological support. Statistical analyses were performed to detect the presence of any correlation between psychological variables at prehospital admission and clinical outcomes. The 40% of patients had significant levels of distress at prehospital admission (PDI ≥ 30). As regards Mini-MAC, the mean value of fighting spirit attitude and fatalism was higher in our sample than in the normative sample of the Mini-MAC validation study in the Italian cancer population. Their anxious preoccupation attitude was lower. There were no correlations between clinical and psychological variables: level of postsurgery pain was higher (3.7) in the subgroup of patients with presurgery PDI < 30 compared with those with PDI ≥ 30 (3.5). However, this difference was not statistically significant (P = 1.00). Considering hospitalization length, the above described trend was similar. Although highly distressed, pelvic exenteration candidates show an adaptive range of coping mechanisms. This calls for a greater effort in studying the complexity of their psychoemotional status to provide them with the best multidisciplinary care. Extensive study of the real effectiveness of psychological intervention is warranted: randomized clinical trials could help in detecting the presence of any correlation between clinical and

Development and Implementation of the Ebola Traveler Monitoring Program and Clinical Outcomes of Monitored Travelers during October - May 2015, Minnesota.

PubMed

DeVries, Aaron; Talley, Pamela; Sweet, Kristin; Kline, Susan; Stinchfield, Patricia; Tosh, Pritish; Danila, Richard

2016-01-01

In October 2014, the United States began actively monitoring all persons who had traveled from Guinea, Liberia, and Sierra Leone in the previous 21 days. State public health departments were responsible for monitoring all travelers; Minnesota has the largest Liberian population in the United States. The MDH Ebola Clinical Team (ECT) was established to assess travelers with symptoms of concern for Ebola virus disease (EVD), coordinate access to healthcare at appropriate facilities including Ebola Assessment and Treatment Units (EATU), and provide guidance to clinicians. Minnesota Department of Health (MDH) began receiving traveler information collected by U.S. Customs and Border Control and Centers for Disease Control and Prevention staff on October 21, 2014 via encrypted electronic communication. All travelers returning from Liberia, Sierra Leone, and Guinea during 10/21/14-5/15/15 were monitored by MDH staff in the manner recommended by CDC based on the traveler's risk categorization as "low (but not zero)", "some" and "high" risk. When a traveler reported symptoms or a temperature ≥100.4° F at any time during their 21-day monitoring period, an ECT member would speak to the traveler and perform a clinical assessment by telephone or via video-chat. Based on the assessment the ECT member would recommend 1) continued clinical monitoring while at home with frequent telephone follow-up by the ECT member, 2) outpatient clinical evaluation at an outpatient site agreed upon by all parties, or 3) inpatient clinical evaluation at one of four Minnesota EATUs. ECT members assessed and approved testing for Ebola virus infection at MDH. Traveler data, calls to the ECT and clinical outcomes were logged on a secure server at MDH. During 10/21/14-5/15/15, a total of 783 travelers were monitored; 729 (93%) traveled from Liberia, 30 (4%) Sierra Leone, and 24 (3%) Guinea. The median number monitored per week was 59 (range 45-143). The median age was 35 years; 136 (17%) were aged

Development and Application of Direct Data Capture for Monitoring Medication Compliance in Clinical Trials.

PubMed

Kim, Eun-Young

2017-10-01

The monitoring of medication compliance in clinical trials is important but labor intensive. To check medication compliance in clinical trials, a system was developed, and its technical feasibility evaluated. The system consisted of three parts: a management part (clinical trial center database and a developed program), clinical trial investigator part (monitoring), and clinical trial participant part (personal digital assistant [PDA] with a barcode scanner). The system was tested with 20 participants for 2 weeks, and compliance was evaluated. This study developed a medication compliance monitoring system that used a PDA with a barcode scanner, which sent reminder/warning messages, logged medication barcode data, and provided compliance information to investigators. Registered participants received short message service (SMS) reminder/warning messages on their PDA and sent barcode data at the dosing time. The age range of the participants was 29 to 73 years. Five participants were <50 years old and 8 were ≥65 years old. The total mean compliance rate was 82.3%. The mean compliance rate was 83.1% in participants <65 years old and 81.1% in those ≥65 years old. The system was feasible, usable, and effective, even with elderly participants, for monitoring medication compliance in clinical trials using a PDA with a barcode scanner, and may improve the quality of clinical trials.

Request for regular monitoring of the symbiotic variable RT Cru

NASA Astrophysics Data System (ADS)

Waagen, Elizabeth O.

2014-08-01

Dr. Margarita Karovska (Harvard-Smithsonian Center for Astrophysics) and colleagues have requested AAVSO observer assistance in their campaign on the symbiotic variable RT Cru (member of a new class of hard X-ray emitting symbiotic binaries). Weekly or more frequent monitoring (B, V, and visual) beginning now is requested in support of upcoming Chandra observations still to be scheduled. "We plan Chandra observations of RT Cru in the near future that will help us understand the characteristics of the accretion onto the white dwarf in this sub-class of symbiotics. This is an important step for determining the precursor conditions for formation of a fraction of asymmetric Planetary Nebulae, and the potential of symbiotic systems as progenitors of at least a fraction of Type Ia supernovae." Finder charts with sequence may be created using the AAVSO Variable Star Plotter (http://www.aavso.org/vsp). Observations should be submitted to the AAVSO International Database. See full Alert Notice for more details and observations.

Difficulty in clinical identification of neonatal seizures: an EEG monitor study.

PubMed Central

Fenichel, G. M.

1987-01-01

Seventeen newborns were monitored for 24 hours using a three-channel ambulatory EEG (A/EEG). All newborns were thought to be having subtle seizures by the nursery staff. Fifteen of the 17 newborns were recorded as having 1-30 clinical seizures during the time of monitoring. Only one newborn had clinically identified seizures associated with A/EEG discharges. The seizures were characterized by eye rolling. Fifty-two episodes (thought to be seizures) of lip smacking, bicycling, jerking, fisting, staring, stiffening, or any combination of the above occurred in eight newborns without an associated discharge on A/EEG. However, two of the eight had seizure discharges at other times, not associated with any clinical manifestation. Seventy-four apnea spells, thought to be possible seizures, occurred in seven newborns. None was associated with discharges on A/EEG, but one of these newborns had 50 A/EEG discharges unrelated to apnea or other clinical manifestations. PMID:3577211

Simultaneous Monitoring of X-ray and Radio Variability in Sagittarius A*

NASA Astrophysics Data System (ADS)

Haggard, Daryl; Capellupo, Daniel M.; Choux, Nicolas; Baganoff, Frederick K.; Bower, Geoffrey C.; Cotton, William D.; Degenaar, Nathalie; Dexter, Jason; Falcke, Heino; Fragile, P. Christopher Christopher; Heinke, Craig O.; Law, Casey J.; Markoff, Sera; Neilsen, Joseph; Ponti, Gabriele; Rea, Nanda; Yusef-Zadeh, Farhad

2017-08-01

We report on joint X-ray/radio campaigns targeting Sagittarius A*, including 9 contemporaneous Chandra and VLA observations. These campaigns are the most extensive of their kind and have allowed us to test whether the black hole’s variations in different parts of the electromagnetic spectrum are due to the same physical processes. We detect significant radio variability peaking >176 minutes after the brightest X-ray flare ever detected from Sgr A*. We also identify other potentially associated X-ray and radio variability, with radio peaks appearing <80 minutes after weaker X-ray flares. These results suggest that stronger X-ray flares lead to longer time lags in the radio. However, we also test the possibility that the variability at X-ray and at radio wavelengths are not temporally correlated, and show that the radio variations occurring around the time of X-ray flaring are not significantly greater than the overall radio flux variations. We also cross-correlate data from mismatched X-ray and radio epochs and obtain comparable correlations to the matched data. Hence, we find no overall statistical evidence that X-ray flares and radio variability are correlated, underscoring a need for more simultaneous, long duration X-ray-radio monitoring of Sgr A*.

Monitoring of clinical strains and environmental fungal aerocontamination to prevent invasive aspergillosis infections in hospital during large deconstruction work: a protocol study

PubMed Central

Loeffert, Sophie Tiphaine; Melloul, Elise; Dananché, Cédric; Hénaff, Laetitia; Bénet, Thomas; Cassier, Pierre; Dupont, Damien; Guillot, Jacques; Botterel, Françoise; Wallon, Martine; Gustin, Marie-Paule; Vanhems, Philippe

2017-01-01

Introduction Monitoring fungal aerocontamination is an essential measure to prevent severe invasive aspergillosis (IA) infections in hospitals. One central block among 32 blocks of Edouard Herriot Hospital (EHH) was entirely demolished in 2015, while care activities continued in surrounding blocks. The main objective was to undertake broad environmental monitoring and clinical surveillance of IA cases to document fungal dispersion during major deconstruction work and to assess clinical risk. Methods and analysis A daily environmental survey of fungal loads was conducted in eight wards located near the demolition site. Air was collected inside and outside selected wards by agar impact samplers. Daily spore concentrations were monitored continuously by volumetric samplers at a flow rate of 10 L.min-1. Daily temperature, wind direction and speed as well as relative humidity were recorded by the French meteorological station Meteociel. Aspergillus fumigatus strains stored will be genotyped by multiple-locus, variable-number, tandem-repeat analysis. Antifungal susceptibility will be assessed by E-test strips on Roswell Park Memorial Institute medium supplemented with agar. Ascertaining the adequacy of current environmental monitoring techniques in hospital is of growing importance, considering the rising impact of fungal infections and of curative antifungal costs. The present study could improve the daily management of IA risk during major deconstruction work and generate new data to ameliorate and redefine current guidelines. Ethics and dissemination This study was approved by the clinical research and ethics committees of EHH. PMID:29175886

Failsafe automation of Phase II clinical trial interim monitoring for stopping rules.

PubMed

Day, Roger S

2010-02-01

In Phase II clinical trials in cancer, preventing the treatment of patients on a study when current data demonstrate that the treatment is insufficiently active or too toxic has obvious benefits, both in protecting patients and in reducing sponsor costs. Considerable efforts have gone into experimental designs for Phase II clinical trials with flexible sample size, usually implemented by early stopping rules. The intended benefits will not ensue, however, if the design is not followed. Despite the best intentions, failures can occur for many reasons. The main goal is to develop an automated system for interim monitoring, as a backup system supplementing the protocol team, to ensure that patients are protected. A secondary goal is to stimulate timely recording of patient assessments. We developed key concepts and performance needs, then designed, implemented, and deployed a software solution embedded in the clinical trials database system. The system has been in place since October 2007. One clinical trial tripped the automated monitor, resulting in e-mails that initiated statistician/investigator review in timely fashion. Several essential contributing activities still require human intervention, institutional policy decisions, and institutional commitment of resources. We believe that implementing the concepts presented here will provide greater assurance that interim monitoring plans are followed and that patients are protected from inadequate response or excessive toxicity. This approach may also facilitate wider acceptance and quicker implementation of new interim monitoring algorithms.

Monitoring trends in bird populations: addressing background levels of annual variability in counts

Treesearch

Jared Verner; Kathryn L. Purcell; Jennifer G. Turner

1996-01-01

Point counting has been widely accepted as a method for monitoring trends in bird populations. Using a rigorously standardized protocol at 210 counting stations at the San Joaquin Experimental Range, Madera Co., California, we have been studying sources of variability in point counts of birds. Vegetation types in the study area have not changed during the 11 years of...

Assessment of intrafamilial clinical variability of poikiloderma with neutropenia by a 10-year follow-up of three affected siblings.

PubMed

Concolino, Daniela; Sestito, Simona; Falvo, Francesca; Romano, Giusy; Ceravolo, Miriam; Anastasio, Elisa; Pensabene, Licia; Colombo, Elisa A; Larizza, Lidia

2018-05-23

Clericuzio-type poikiloderma with neutropenia is a well-defined nosological entity, but despite a remarkable number of clinical reports, no long term follow-up data has been presented to date regarding patients with this rare condition. Here we describe the results of clinical follow-up of three siblings, one male (Patient 1) and two females (Patients 2 and 3), subsequent to their first clinical and then molecular diagnosis of Clericuzio-type poikiloderma with neutropenia syndrome due to mutation of USB1gene. Patient 1 always expressed the most severe phenotype, while patients 2 and 3 showed an intermediate and mild phenotype, respectively, as observed since their first clinical evaluation. None of the patients developed skin cancer and/or myelodysplastic disorders considering the peripheral haematological findings. Lens opacity, never reported before, was found in two of the three patients. The long term follow-up observations confirm the stability over time of the pronounced intra-familial heterogeneity of clinical manifestations observed prior to and upon molecular diagnosis. We conclude that prolonged follow-up is an adjunct tool to monitor intra-familial variability of PN clinical spectrum which may favour surveillance of more serious complications of the disease among siblings, when a patient-specific clinical expressivity is present. Copyright © 2018. Published by Elsevier Masson SAS.

Monitoring Climate Variability and Change in Northern Alaska: Updates to the U.S. Geological Survey (USGS) Climate and Permafrost Monitoring Network

NASA Astrophysics Data System (ADS)

Urban, F. E.; Clow, G. D.; Meares, D. C.

2004-12-01

Observations of long-term climate and surficial geological processes are sparse in most of the Arctic, despite the fact that this region is highly sensitive to climate change. Instrumental networks that monitor the interplay of climatic variability and geological/cryospheric processes are a necessity for documenting and understanding climate change. Improvements to the spatial coverage and temporal scale of Arctic climate data are in progress. The USGS, in collaboration with The Bureau of Land Management (BLM) and The Fish and Wildlife Service (FWS) currently maintains two types of monitoring networks in northern Alaska: (1) A 15 site network of continuously operating active-layer and climate monitoring stations, and (2) a 21 element array of deep bore-holes in which the thermal state of deep permafrost is monitored. Here, we focus on the USGS Alaska Active Layer and Climate Monitoring Network (AK-CLIM). These 15 stations are deployed in longitudinal transects that span Alaska north of the Brooks Range, (11 in The National Petroleum Reserve Alaska, (NPRA), and 4 in The Arctic National Wildlife Refuge (ANWR)). An informative overview and update of the USGS AK-CLIM network is presented, including insight to current data, processing and analysis software, and plans for data telemetry. Data collection began in 1998 and parameters currently measured include air temperature, soil temperatures (5-120 cm), snow depth, incoming and reflected short-wave radiation, soil moisture (15 cm), wind speed and direction. Custom processing and analysis software has been written that calculates additional parameters such as active layer thaw depth, thawing-degree-days, albedo, cloudiness, and duration of seasonal snow cover. Data from selected AK-CLIM stations are now temporally sufficient to begin identifying trends, anomalies, and inter-annual variability in the climate of northern Alaska.

Assessment of the clinical efficacy of the heart spectrum blood pressure monitor for diagnosis of atrial fibrillation: An unblinded clinical trial.

PubMed

Kao, Wei-Fong; Hou, Sen-Kuang; Huang, Chun-Yao; Chao, Chun-Chieh; Cheng, Chung-Chih; Chen, Yi-Jung

2018-01-01

Atrial fibrillation (AF) is the most common arrhythmia. The most common diagnostic method, 12-lead electrocardiogram (ECG), can record episodes of arrhythmia from which the type and severity can be determined. The Heart Spectrum Blood Pressure Monitor (P2; OSTAR Meditech Corp., New Taipei City, Taiwan) is used to measure cardiovascular pressure change with fast Fourier transform (FFT) analysis to obtain heart rate frequency variability and accurate blood pressure data. We compared the diagnostic efficacy of the Heart Spectrum Blood Pressure Monitor to a 12-lead ECG (gold standard) for patients with AF. Three measurement methods were used in this study to analyze the heart index and compare the results with simultaneous 12-lead ECG: blood pressure; mean arterial pressure, which was calculated from individual blood pressure as a constant pressure; and a constant pressure of 60 mmHg. The physician used a 12-lead ECG and the Heart Spectrum Blood Pressure Monitor simultaneously. The Heart Spectrum Blood Pressure Monitor used FFT analysis to diagnose AF, and the findings were compared to the 12-lead ECG readings. This unblinded clinical trial was conducted in the emergency department of Taipei Medical University Hospital. Twenty-nine subjects with AF and 33 without AF aged 25 to 97 y (mean, 63.5 y) were included. Subjects who were exposed to high-frequency surgical equipment during testing, those with cardiac pacemakers or implantable defibrillators, and pregnant women were excluded. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 97%, 97%, 97%, and 97%, respectively, for method 1; 90%, 100%, 100%, and 91%, respectively, for method 2; and 100%, 94%, 94%, and 100%, respectively, for method 3. The sensitivity, specificity, PPV, and NPV for both methods ranged between 90% and 100%, indicating that the Heart Spectrum Blood Pressure Monitor can be effectively applied for AF detection.

Assessment of the clinical efficacy of the heart spectrum blood pressure monitor for diagnosis of atrial fibrillation: An unblinded clinical trial

PubMed Central

Kao, Wei-Fong; Hou, Sen-Kuang; Huang, Chun-Yao; Cheng, Chung-Chih; Chen, Yi-Jung

2018-01-01

Atrial fibrillation (AF) is the most common arrhythmia. The most common diagnostic method, 12-lead electrocardiogram (ECG), can record episodes of arrhythmia from which the type and severity can be determined. The Heart Spectrum Blood Pressure Monitor (P2; OSTAR Meditech Corp., New Taipei City, Taiwan) is used to measure cardiovascular pressure change with fast Fourier transform (FFT) analysis to obtain heart rate frequency variability and accurate blood pressure data. We compared the diagnostic efficacy of the Heart Spectrum Blood Pressure Monitor to a 12-lead ECG (gold standard) for patients with AF. Three measurement methods were used in this study to analyze the heart index and compare the results with simultaneous 12-lead ECG: blood pressure; mean arterial pressure, which was calculated from individual blood pressure as a constant pressure; and a constant pressure of 60 mmHg. The physician used a 12-lead ECG and the Heart Spectrum Blood Pressure Monitor simultaneously. The Heart Spectrum Blood Pressure Monitor used FFT analysis to diagnose AF, and the findings were compared to the 12-lead ECG readings. This unblinded clinical trial was conducted in the emergency department of Taipei Medical University Hospital. Twenty-nine subjects with AF and 33 without AF aged 25 to 97 y (mean, 63.5 y) were included. Subjects who were exposed to high-frequency surgical equipment during testing, those with cardiac pacemakers or implantable defibrillators, and pregnant women were excluded. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 97%, 97%, 97%, and 97%, respectively, for method 1; 90%, 100%, 100%, and 91%, respectively, for method 2; and 100%, 94%, 94%, and 100%, respectively, for method 3. The sensitivity, specificity, PPV, and NPV for both methods ranged between 90% and 100%, indicating that the Heart Spectrum Blood Pressure Monitor can be effectively applied for AF detection. PMID:29902218

Formant Frequencies and Bandwidths in Relation to Clinical Variables in an Obstructive Sleep Apnea Population.

PubMed

Montero Benavides, Ana; Blanco Murillo, José Luis; Fernández Pozo, Rubén; Espinoza Cuadros, Fernando; Torre Toledano, Doroteo; Alcázar-Ramírez, José D; Hernández Gómez, Luis A

2016-01-01

We investigated whether differences in formants and their bandwidths, previously reported comparing small sample population of healthy individuals and patients with obstructive sleep apnea (OSA), are detected on a larger population representative of a clinical practice scenario. We examine possible indirect or mediated effects of clinical variables, which may shed some light on the connection between speech and OSA. In a retrospective study, 241 male subjects suspected to suffer from OSA were examined. The apnea-hypopnea index (AHI) was obtained for every subject using overnight polysomnography. Furthermore, the clinical variables usually reported as predictors of OSA, body mass index (BMI), cervical perimeter, height, weight, and age, were collected. Voice samples of sustained phonations of the vowels /a/, /e/, /i/, /o/, and /u/ were recorded. Formant frequencies F1, F2, and F3 and bandwidths BW1, BW2, and BW3 of the sustained vowels were determined using spectrographic analysis. Correlations among AHI, clinical parameters, and formants and bandwidths were determined. Correlations between AHI and clinical variables were stronger than those between AHI and voice features. AHI only correlates poorly with BW2 of /a/ and BW3 of /e/. A number of further weak but significant correlations have been detected between voice and clinical variables. Most of them were for height and age, with two higher values for age and F2 of /o/ and F2 of /u/. Only few very weak correlations were detected between voice and BMI, weight and cervical perimeter, wich are the clinical variables more correlated with AHI. No significant correlations were detected between AHI and formant frequencies and bandwidths. Correlations between voice and other clinical factors characterizing OSA are weak but highlight the importance of considering indirect or mediated effects of such clinical variables in any research on speech and OSA. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All

HIV-1 Genetic Variability in Cuba and Implications for Transmission and Clinical Progression.

PubMed

Blanco, Madeline; Machado, Liuber Y; Díaz, Héctor; Ruiz, Nancy; Romay, Dania; Silva, Eladio

2015-10-01

INTRODUCTION Serological and molecular HIV-1 studies in Cuba have shown very low prevalence of seropositivity, but an increasing genetic diversity attributable to introduction of many HIV-1 variants from different areas, exchange of such variants among HIV-positive people with several coinciding routes of infection and other epidemiologic risk factors in the seropositive population. The high HIV-1 genetic variability observed in Cuba has possible implications for transmission and clinical progression. OBJECTIVE Study genetic variability for the HIV-1 env, gag and pol structural genes in Cuba; determine the prevalence of B and non-B subtypes according to epidemiologic and behavioral variables and determine whether a relationship exists between genetic variability and transmissibility, and between genetic variability and clinical disease progression in people living with HIV/AIDS. METHODS Using two molecular assays (heteroduplex mobility assay and nucleic acid sequencing), structural genes were characterized in 590 people with HIV-1 (480 men and 110 women), accounting for 3.4% of seropositive individuals in Cuba as of December 31, 2013. Nonrandom sampling, proportional to HIV prevalence by province, was conducted. Relationships between molecular results and viral factors, host characteristics, and patients' clinical, epidemiologic and behavioral variables were studied for molecular epidemiology, transmission, and progression analyses. RESULTS Molecular analysis of the three HIV-1 structural genes classified 297 samples as subtype B (50.3%), 269 as non-B subtypes (45.6%) and 24 were not typeable. Subtype B prevailed overall and in men, mainly in those who have sex with men. Non-B subtypes were prevalent in women and heterosexual men, showing multiple circulating variants and recombinant forms. Sexual transmission was the predominant form of infection for all. B and non-B subtypes were encountered throughout Cuba. No association was found between subtypes and

Visit-to-visit cholesterol variability correlates with coronary atheroma progression and clinical outcomes.

PubMed

Clark, Donald; Nicholls, Stephen J; St John, Julie; Elshazly, Mohamed B; Kapadia, Samir R; Tuzcu, E Murat; Nissen, Steven E; Puri, Rishi

2018-04-21

Utilizing serial intravascular ultrasonography (IVUS), we aimed to exam the association of intra-individual lipid variability, coronary atheroma progression, and clinical outcomes. We performed a post hoc patient-level analysis of nine clinical trials involving 4976 patients with coronary artery disease who underwent serial coronary IVUS in the setting of a range of medical therapies. We assessed the associations between progression in percent atheroma volume (ΔPAV), clinical outcomes, and visit-to-visit lipid variability including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol (TC)/HDL-C, and apolipoprotein B (ApoB). Variability of lipid parameters was measured using intra-individual standard deviation over 3, 6, 12, 18, and 24 months. Atherogenic lipoprotein variability significantly associated with ΔPAV [odds ratio (95% confidence interval; P-value), LDL-C: 1.09 (1.02, 1.17, P = 0.01); non-HDL-C: 1.10 (1.02, 1.18, P = 0.01); TC/HDL-C: 1.14 (1.06, 1.24, P = 0.001); ApoB: 1.13 (1.03, 1.24, P = 0.01)]. Survival curves revealed significant stepwise relationships between cumulative major adverse cardiovascular events and increasing quartiles of atherogenic lipoprotein variability at 24-months follow-up (log-rank P < 0.01 for all lipoproteins except HDL-C). Stronger associations were noted between achieved lipoprotein levels and ΔPAV [LDL-C: 1.27 (1.17, 1.39; P < 0.001); non-HDL-C: 1.32 (1.21, 1.45; P < 0.001); TC/HDL-C: 1.31 (1.19, 1.45; P < 0.001); ApoB: 1.20 (1.07, 1.35; P = 0.003)]. Greater visit-to-visit variability in atherogenic lipoprotein levels significantly associates with coronary atheroma progression and clinical outcomes, although the association between achieved atherogenic lipoproteins and atheroma progression appears stronger. These data highlight the importance of achieving low and consistent atherogenic lipoprotein levels to promote

Wearable sweat detector device design for health monitoring and clinical diagnosis

NASA Astrophysics Data System (ADS)

Wu, Qiuchen; Zhang, Xiaodong; Tian, Bihao; Zhang, Hongyan; Yu, Yang; Wang, Ming

2017-06-01

Miniaturized sensor is necessary part for wearable detector for biomedical applications. Wearable detector device is indispensable for online health care. This paper presents a concept of an wearable digital health monitoring device design for sweat analysis. The flexible sensor is developed to quantify the amount of hydrogen ions in sweat and skin temperature in real time. The detection system includes pH sensor, temperature sensor, signal processing module, power source, microprocessor, display module and so on. The sweat monitoring device is designed for sport monitoring or clinical diagnosis.

Development and Implementation of the Ebola Traveler Monitoring Program and Clinical Outcomes of Monitored Travelers during October – May 2015, Minnesota

PubMed Central

DeVries, Aaron; Talley, Pamela; Sweet, Kristin; Kline, Susan; Stinchfield, Patricia; Tosh, Pritish; Danila, Richard

2016-01-01

Background In October 2014, the United States began actively monitoring all persons who had traveled from Guinea, Liberia, and Sierra Leone in the previous 21 days. State public health departments were responsible for monitoring all travelers; Minnesota has the largest Liberian population in the United States. The MDH Ebola Clinical Team (ECT) was established to assess travelers with symptoms of concern for Ebola virus disease (EVD), coordinate access to healthcare at appropriate facilities including Ebola Assessment and Treatment Units (EATU), and provide guidance to clinicians. Methods Minnesota Department of Health (MDH) began receiving traveler information collected by U.S. Customs and Border Control and Centers for Disease Control and Prevention staff on October 21, 2014 via encrypted electronic communication. All travelers returning from Liberia, Sierra Leone, and Guinea during 10/21/14–5/15/15 were monitored by MDH staff in the manner recommended by CDC based on the traveler’s risk categorization as “low (but not zero)”, “some” and “high” risk. When a traveler reported symptoms or a temperature ≥100.4° F at any time during their 21-day monitoring period, an ECT member would speak to the traveler and perform a clinical assessment by telephone or via video-chat. Based on the assessment the ECT member would recommend 1) continued clinical monitoring while at home with frequent telephone follow-up by the ECT member, 2) outpatient clinical evaluation at an outpatient site agreed upon by all parties, or 3) inpatient clinical evaluation at one of four Minnesota EATUs. ECT members assessed and approved testing for Ebola virus infection at MDH. Traveler data, calls to the ECT and clinical outcomes were logged on a secure server at MDH. Results During 10/21/14–5/15/15, a total of 783 travelers were monitored; 729 (93%) traveled from Liberia, 30 (4%) Sierra Leone, and 24 (3%) Guinea. The median number monitored per week was 59 (range 45–143). The

Monitoring of cerebral hemodynamics and oxygenation by continuous-wave optical spectroscopy during asphyxia in newborn piglets

NASA Astrophysics Data System (ADS)

Stankovic, Miljan R.; Fujii, Alan M.; Kirby, Debra; Boas, David A.; Ntziachristos, Vasilis; Stubblefield, Phillip G.

1997-12-01

The present study demonstrated that optical variables HbT and SmcO2 can be used to monitor changes in cerebral hemodynamics and oxygenation during asphyxia. Unfortunately none of the individual optical variables alone could be used to monitor changes in cerebral hemodynamics and oxygenation under a variety of possible clinical circumstances. However, all variables together, forming patterns unique to the commonly occurring physiological conditions, might potentially serve as a `silver standard' to aid interpretations of optical signals in clinical settings where `gold standard' techniques are not available, i.g. in the human fetus and neonate.

Monitoring of cerebral hemodynamics and oxygenation by continuous-wave optical spectroscopy during asphyxia in newborn piglets

NASA Astrophysics Data System (ADS)

Stankovic, Miljan R.; Fujii, Alan M.; Kirby, Debra; Boas, David A.; Ntziachristos, Vasilis; Stubblefield, Phillip G.

1998-01-01

The present study demonstrated that optical variables HbT and SmcO2 can be used to monitor changes in cerebral hemodynamics and oxygenation during asphyxia. Unfortunately none of the individual optical variables alone could be used to monitor changes in cerebral hemodynamics and oxygenation under a variety of possible clinical circumstances. However, all variables together, forming patterns unique to the commonly occurring physiological conditions, might potentially serve as a `silver standard' to aid interpretations of optical signals in clinical settings where `gold standard' techniques are not available, i.g. in the human fetus and neonate.

Clinical outcome of continuous facial nerve monitoring during primary parotidectomy.

PubMed

Terrell, J E; Kileny, P R; Yian, C; Esclamado, R M; Bradford, C R; Pillsbury, M S; Wolf, G T

1997-10-01

To assess whether continuous facial nerve monitoring during parotidectomy is associated with a lower incidence of facial nerve paresis or paralysis compared with parotidectomy without monitoring and to assess the cost of such monitoring. A retrospective analysis of outcomes for patients who underwent parotidectomy with or without continuous facial nerve monitoring. University medical center. Fifty-six patients undergoing parotidectomy in whom continuous electromyographic monitoring was used and 61 patients in whom it was not used. (1) The incidence of early and persistent facial nerve paresis or paralysis and (2) the cost associated with facial nerve monitoring. Early, unintentional facial weakness was significantly lower in the group monitored by electromyograpy (43.6%) than in the unmonitored group (62.3%) (P=.04). In the subgroup of patients without comorbid conditions or surgeries, early weakness in the monitored group (33.3%) remained statistically lower than the rate of early weakness in the unmonitored group (57.5%) (P=.03). There was no statistical difference in the final facial nerve function or incidence of permanent nerve injury between the groups or subgroups. After multivariate analysis, nonmonitored status (odds ratio [OR], 3.22), advancing age (OR, 1.47 per 10 years), and longer operative times (OR, 1.3 per hour) were the only significant independent predictive variables significantly associated with early postoperative facial weakness. The incremental cost of facial nerve monitoring was $379. The results suggest that continuous electromyographic monitoring of facial muscle during primary parotidectomy reduces the incidence of short-term postoperative facial paresis. Advantages and disadvantages of this technique need to be considered together with the additional costs in deciding whether routine use of continuous monitoring is a useful, cost-effective adjunct to parotid surgery.

T-wave alternans and beat-to-beat variability of repolarization: pathophysiological backgrounds and clinical relevance.

PubMed

Floré, Vincent; Willems, Rik

2012-12-01

In this review, we focus on temporal variability of cardiac repolarization. This phenomenon has been related to a higher risk for ventricular arrhythmia and is therefore interesting as a marker of sudden cardiac death risk. We review two non-invasive clinical techniques quantifying repolarization variability: T-wave alternans (TWA) and beat-to-beat variability of repolarization (BVR). We discuss their pathophysiological link with ventricular arrhythmia and the current clinical relevance of these techniques.

Investigation of clinical pharmacokinetic variability of an opioid antagonist through physiologically based absorption modeling.

PubMed

Ding, Xuan; He, Minxia; Kulkarni, Rajesh; Patel, Nita; Zhang, Xiaoyu

2013-08-01

Identifying the source of inter- and/or intrasubject variability in pharmacokinetics (PK) provides fundamental information in understanding the pharmacokinetics-pharmacodynamics relationship of a drug and project its efficacy and safety in clinical populations. This identification process can be challenging given that a large number of potential causes could lead to PK variability. Here we present an integrated approach of physiologically based absorption modeling to investigate the root cause of unexpectedly high PK variability of a Phase I clinical trial drug. LY2196044 exhibited high intersubject variability in the absorption phase of plasma concentration-time profiles in humans. This could not be explained by in vitro measurements of drug properties and excellent bioavailability with low variability observed in preclinical species. GastroPlus™ modeling suggested that the compound's optimal solubility and permeability characteristics would enable rapid and complete absorption in preclinical species and in humans. However, simulations of human plasma concentration-time profiles indicated that despite sufficient solubility and rapid dissolution of LY2196044 in humans, permeability and/or transit in the gastrointestinal (GI) tract may have been negatively affected. It was concluded that clinical PK variability was potentially due to the drug's antagonism on opioid receptors that affected its transit and absorption in the GI tract. Copyright © 2013 Wiley Periodicals, Inc.

78 FR 48173 - Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

...] Guidance for Industry on Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring... Administration (FDA) is announcing the availability of a guidance for industry entitled ``Oversight of Clinical... monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and...

Quality assurance for the clinical implementation of kilovoltage intrafraction monitoring for prostate cancer VMAT

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ng, J. A.; Booth, J. T.; O’Brien, R. T.

2014-11-01

Purpose: Kilovoltage intrafraction monitoring (KIM) is a real-time 3D tumor monitoring system for cancer radiotherapy. KIM uses the commonly available gantry-mounted x-ray imager as input, making this method potentially more widely available than dedicated real-time 3D tumor monitoring systems. KIM is being piloted in a clinical trial for prostate cancer patients treated with VMAT (NCT01742403). The purpose of this work was to develop clinical process and quality assurance (QA) practices for the clinical implementation of KIM. Methods: Informed by and adapting existing guideline documents from other real-time monitoring systems, KIM-specific QA practices were developed. The following five KIM-specific QA testsmore » were included: (1) static localization accuracy, (2) dynamic localization accuracy, (3) treatment interruption accuracy, (4) latency measurement, and (5) clinical conditions accuracy. Tests (1)–(4) were performed using KIM to measure static and representative patient-derived prostate motion trajectories using a 3D programmable motion stage supporting an anthropomorphic phantom with implanted gold markers to represent the clinical treatment scenario. The threshold for system tolerable latency is <1 s. The tolerances for all other tests are that both the mean and standard deviation of the difference between the programmed trajectory and the measured data are <1 mm. The (5) clinical conditions accuracy test compared the KIM measured positions with those measured by kV/megavoltage (MV) triangulation from five treatment fractions acquired in a previous pilot study. Results: For the (1) static localization, (2) dynamic localization, and (3) treatment interruption accuracy tests, the mean and standard deviation of the difference are <1.0 mm. (4) The measured latency is 350 ms. (5) For the tests with previously acquired patient data, the mean and standard deviation of the difference between KIM and kV/MV triangulation are <1.0 mm. Conclusions: Clinical

Monitoring of continuous-variable quantum key distribution system in real environment.

PubMed

Liu, Weiqi; Peng, Jinye; Huang, Peng; Huang, Duan; Zeng, Guihua

2017-08-07

How to guarantee the practical security of continuous-variable quantum key distribution (CVQKD) system has been an important issue in the quantum cryptography applications. In contrast to the previous practical security strategies, which focus on the intercept-resend attack or the Gaussian attack, we investigate the practical security strategy based on a general attack, i.e., an arbitrated individual attack or collective attack on the system by Eve in this paper. The low bound of intensity disturbance of the local oscillator signal for eavesdropper successfully concealing herself is obtained, considering all noises can be used by Eve in the practical environment. Furthermore, we obtain an optimal monitoring condition for the practical CVQKD system so that legitimate communicators can monitor the general attack in real-time. As examples, practical security of two special systems, i.e., the Gaussian modulated coherent state CVQKD system and the middle-based CVQKD system, are investigated under the intercept-resend attacks.

Ambient intelligence for monitoring and research in clinical neurophysiology and medicine: the MIMERICA* project and prototype.

PubMed

Pignolo, L; Riganello, F; Dolce, G; Sannita, W G

2013-04-01

Ambient Intelligence (AmI) provides extended but unobtrusive sensing and computing devices and ubiquitous networking for human/environment interaction. It is a new paradigm in information technology compliant with the international Integrating Healthcare Enterprise board (IHE) and eHealth HL7 technological standards in the functional integration of biomedical domotics and informatics in hospital and home care. AmI allows real-time automatic recording of biological/medical information and environmental data. It is extensively applicable to patient monitoring, medicine and neuroscience research, which require large biomedical data sets; for example, in the study of spontaneous or condition-dependent variability or chronobiology. In this respect, AML is equivalent to a traditional laboratory for data collection and processing, with minimal dedicated equipment, staff, and costs; it benefits from the integration of artificial intelligence technology with traditional/innovative sensors to monitor clinical or functional parameters. A prototype AmI platform (MIMERICA*) has been implemented and is operated in a semi-intensive unit for the vegetative and minimally conscious states, to investigate the spontaneous or environment-related fluctuations of physiological parameters in these conditions.

Impact of menstruation on select hematology and clinical chemistry variables in cynomolgus macaques.

PubMed

Perigard, Christopher J; Parrula, M Cecilia M; Larkin, Matthew H; Gleason, Carol R

2016-06-01

In preclinical studies with cynomolgus macaques, it is common to have one or more females presenting with menses. Published literature indicates that the blood lost during menses causes decreases in red blood cell mass variables (RBC, HGB, and HCT), which would be a confounding factor in the interpretation of drug-related effects on clinical pathology data, but no scientific data have been published to support this claim. This investigation was conducted to determine if the amount of blood lost during menses in cynomolgus macaques has an effect on routine hematology and serum chemistry variables. Ten female cynomolgus macaques (Macaca fascicularis), 5 to 6.5 years old, were observed daily during approximately 3 months (97 days) for the presence of menses. Hematology and serum chemistry variables were evaluated twice weekly. The results indicated that menstruation affects the erythrogram including RBC, HGB, HCT, MCHC, MCV, reticulocyte count, RDW, the leukogram including neutrophil, lymphocyte, and monocyte counts, and chemistry variables, including GGT activity, and the concentrations of total proteins, albumin, globulins, and calcium. The magnitude of the effect of menstruation on susceptible variables is dependent on the duration of the menstrual phase. Macaques with menstrual phases lasting ≥ 7 days are more likely to develop changes in variables related to chronic blood loss. In preclinical toxicology studies with cynomolgus macaques, interpretation of changes in several commonly evaluated hematology and serum chemistry variables requires adequate clinical observation and documentation concerning presence and duration of menses. There is a concern that macaques with long menstrual cycles can develop iron deficiency anemia due to chronic menstrual blood loss. © 2016 American Society for Veterinary Clinical Pathology.

Vital signs monitoring to detect patient deterioration: An integrative literature review.

PubMed

Mok, Wen Qi; Wang, Wenru; Liaw, Sok Ying

2015-05-01

Vital signs monitoring is an important nursing assessment. Yet, nurses seem to be doing it as part of a routine and often overlooking their significance in detecting patient deterioration. An integrative literature review was conducted to explore factors surrounding ward nursing practice of vital signs monitoring in detecting and reporting deterioration. Twenty papers were included. The structural component of a Nursing Role Effectiveness Model framework, which comprises of patient, nurse and organizational variables, was used to synthesize the review. Patient variables include signs of deterioration displayed by patients which include physical cues and abnormal vital signs. Nursing variables include clinical knowledge, roles and responsibilities, and reporting of deteriorating vital signs. Organizational variables include heavy workload, technology, and observation chart design. This review has highlighted current nursing practice in vital signs monitoring. A myriad of factors were found to surround ward practice of vital signs monitoring in detecting and reporting deterioration. © 2015 Wiley Publishing Asia Pty Ltd.

Earpiece with sensors to measure/monitor multiple physiological variables

NASA Technical Reports Server (NTRS)

Cooper, Tommy G. (Inventor); Schulze, Arthur E. (Inventor)

2003-01-01

An apparatus and method for positioning sensors relative to one another and anatomic features in a non-invasive device for measuring and monitoring multiple physiological variables from a single site uses an earpiece incorporating a shielded pulse oximetry sensor (POS) having a miniaturized set of LEDs and photosensors configured for pulse oximetry measurements in the reflectance mode and located in the earpiece so as to position the POS against a rear wall of an ear canal. The earpiece also includes a thermopile of no larger than 7 mm. in diameter located on the earpiece to so as to position the thermopile past a second turn of an external auditory meatus so as to view the tympanic membrane. The thermopile includes a reference temperature sensor attached to its base for ambient temperature compensation.

Variability sensitivity of dynamic texture based recognition in clinical CT data

NASA Astrophysics Data System (ADS)

Kwitt, Roland; Razzaque, Sharif; Lowell, Jeffrey; Aylward, Stephen

2014-03-01

Dynamic texture recognition using a database of template models has recently shown promising results for the task of localizing anatomical structures in Ultrasound video. In order to understand its clinical value, it is imperative to study the sensitivity with respect to inter-patient variability as well as sensitivity to acquisition parameters such as Ultrasound probe angle. Fully addressing patient and acquisition variability issues, however, would require a large database of clinical Ultrasound from many patients, acquired in a multitude of controlled conditions, e.g., using a tracked transducer. Since such data is not readily attainable, we advocate an alternative evaluation strategy using abdominal CT data as a surrogate. In this paper, we describe how to replicate Ultrasound variabilities by extracting subvolumes from CT and interpreting the image material as an ordered sequence of video frames. Utilizing this technique, and based on a database of abdominal CT from 45 patients, we report recognition results on an organ (kidney) recognition task, where we try to discriminate kidney subvolumes/videos from a collection of randomly sampled negative instances. We demonstrate that (1) dynamic texture recognition is relatively insensitive to inter-patient variation while (2) viewing angle variability needs to be accounted for in the template database. Since naively extending the template database to counteract variability issues can lead to impractical database sizes, we propose an alternative strategy based on automated identification of a small set of representative models.

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2010 CFR

2010-04-01

... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be...

Validation of a metered dose inhaler electronic monitoring device: implications for asthma clinical trial use.

PubMed

Pilcher, Janine; Holliday, Mark; Ebmeier, Stefan; McKinstry, Steve; Messaoudi, Fatiha; Weatherall, Mark; Beasley, Richard

2016-01-01

The SmartTouch Ventolin monitor (Adherium, Auckland, New Zealand) is an electronic monitor for use with a Ventolin metered dose inhaler, which records the date and time of inhaler actuations. This technology has the potential to allow in-depth analysis of patterns of inhaler use in clinical trial settings. The aim of this study was to determine the accuracy of the SmartTouch Ventolin monitor in recording Ventolin actuations. 20 SmartTouch Ventolin monitors were attached to Ventolin metered dose inhalers. Bench testing was performed over a 10-week period, to reflect the potential time frame between visits in a clinical trial. Inhaler actuations were recorded in a paper diary, which was compared with data uploaded from the monitors. 2560 actuations were performed during the 10-week study period. Monitor sensitivity for diary-recorded actuations was 99.9% with a lower 97.5% confidence bound of 99.7%. The positive predictive value for diary-recorded actuations was 100% with a 97.5% lower confidence bound of 99.9%. The SmartTouch Ventolin monitor is highly accurate in recording and retaining electronic data. It can be recommended for use in clinical trial settings in which training and quality control systems are incorporated into study protocols to ensure accurate data acquisition.

Validation of a metered dose inhaler electronic monitoring device: implications for asthma clinical trial use

PubMed Central

Pilcher, Janine; Holliday, Mark; Ebmeier, Stefan; McKinstry, Steve; Messaoudi, Fatiha; Weatherall, Mark; Beasley, Richard

2016-01-01

Background The SmartTouch Ventolin monitor (Adherium, Auckland, New Zealand) is an electronic monitor for use with a Ventolin metered dose inhaler, which records the date and time of inhaler actuations. This technology has the potential to allow in-depth analysis of patterns of inhaler use in clinical trial settings. The aim of this study was to determine the accuracy of the SmartTouch Ventolin monitor in recording Ventolin actuations. Methods 20 SmartTouch Ventolin monitors were attached to Ventolin metered dose inhalers. Bench testing was performed over a 10-week period, to reflect the potential time frame between visits in a clinical trial. Inhaler actuations were recorded in a paper diary, which was compared with data uploaded from the monitors. Results 2560 actuations were performed during the 10-week study period. Monitor sensitivity for diary-recorded actuations was 99.9% with a lower 97.5% confidence bound of 99.7%. The positive predictive value for diary-recorded actuations was 100% with a 97.5% lower confidence bound of 99.9%. Conclusions The SmartTouch Ventolin monitor is highly accurate in recording and retaining electronic data. It can be recommended for use in clinical trial settings in which training and quality control systems are incorporated into study protocols to ensure accurate data acquisition. PMID:27026805

Post-Surgical Clinical Monitoring of Soft Tissue Wound Healing in Periodontal and Implant Surgery

PubMed Central

Pippi, Roberto

2017-01-01

Clinical features of surgical soft tissue wound healing in dentistry have been rarely discussed in the international literature. The aim of the present paper is to highlight both the main clinical findings of surgical wound healing, especially in periodontal and implant dentistry, and the wound healing monitoring procedures which should be followed. Wound inspection after careful food and plaque debridement is the essential part of wound healing monitoring. Periodontal and peri-implant probing should be performed only after tissue healing has been completed and not on a weekly basis in peri-implant tissue monitoring. Telephone follow-up and patient self-assessment scales can also be used the days following surgery to monitor the most common surgical complications such as pain, swelling, bleeding, and bruising. Wound healing monitoring is an important concern in all surgical procedures since it allows to identify signs or/and symptoms possibly related to surgical complications. PMID:28824306

Post-Surgical Clinical Monitoring of Soft Tissue Wound Healing in Periodontal and Implant Surgery.

PubMed

Pippi, Roberto

2017-01-01

Clinical features of surgical soft tissue wound healing in dentistry have been rarely discussed in the international literature. The aim of the present paper is to highlight both the main clinical findings of surgical wound healing, especially in periodontal and implant dentistry, and the wound healing monitoring procedures which should be followed. Wound inspection after careful food and plaque debridement is the essential part of wound healing monitoring. Periodontal and peri-implant probing should be performed only after tissue healing has been completed and not on a weekly basis in peri-implant tissue monitoring. Telephone follow-up and patient self-assessment scales can also be used the days following surgery to monitor the most common surgical complications such as pain, swelling, bleeding, and bruising. Wound healing monitoring is an important concern in all surgical procedures since it allows to identify signs or/and symptoms possibly related to surgical complications.

Risk based monitoring (RBM) tools for clinical trials: A systematic review.

PubMed

Hurley, Caroline; Shiely, Frances; Power, Jessica; Clarke, Mike; Eustace, Joseph A; Flanagan, Evelyn; Kearney, Patricia M

2016-11-01

In November 2016, the Integrated Addendum to ICH-GCP E6 (R2) will advise trial sponsors to develop a risk-based approach to clinical trial monitoring. This new process is commonly known as risk based monitoring (RBM). To date, a variety of tools have been developed to guide RBM. However, a gold standard approach does not exist. This review aims to identify and examine RBM tools. Review of published and grey literature using a detailed search-strategy and cross-checking of reference lists. This review included academic and commercial instruments that met the Organisation for Economic Co-operation and Development (OECD) classification of RBM tools. Ninety-one potential RBM tools were identified and 24 were eligible for inclusion. These tools were published between 2000 and 2015. Eight tools were paper based or electronic questionnaires and 16 operated as Service as a System (SaaS). Risk associated with the investigational medicinal product (IMP), phase of the clinical trial and study population were examined by all tools and suitable mitigation guidance through on-site and centralised monitoring was provided. RBM tools for clinical trials are relatively new, their features and use varies widely and they continue to evolve. This makes it difficult to identify the "best" RBM technique or tool. For example, equivalence testing is required to determine if RBM strategies directed by paper based and SaaS based RBM tools are comparable. Such research could be embedded within multi-centre clinical trials and conducted as a SWAT (Study within a Trial). Copyright © 2016 Elsevier Inc. All rights reserved.

Factors associated with poor functional outcome in bipolar disorder: sociodemographic, clinical, and neurocognitive variables.

PubMed

Sanchez-Moreno, J; Bonnin, C M; González-Pinto, A; Amann, B L; Solé, B; Balanzá-Martinez, V; Arango, C; Jiménez, E; Tabarés-Seisdedos, R; Garcia-Portilla, M P; Ibáñez, A; Crespo, J M; Ayuso-Mateos, J L; Martinez-Aran, A; Torrent, C; Vieta, E

2018-05-03

The current investigation aimed at studying the sociodemographic, clinical, and neuropsychological variables related to functional outcome in a sample of euthymic patients with bipolar disorder(BD) presenting moderate-severe levels of functional impairment. Two-hundred and thirty-nine participants with BD disorders and with Functioning Assessment Short Test(FAST) scores equal or above 18 were administered a clinical and diagnostic interview, and the administration of mood measure scales and a comprehensive neuropsychological battery. Analyses involved preliminary Pearson bivariate correlations to identify sociodemographic and clinical variables associated with the FAST total score. Regarding neuropsychological variables, a principal component analysis (PCA) was performed to group the variables in orthogonal factors. Finally, a hierarchical multiple regression was run. The best fitting model for the variables associated with functioning was a linear combination of gender, age, estimated IQ, Hamilton Depression Rating Scale (HAM-D), number of previous manic episodes, Factor 1 and Factor 2 extracted from the PCA. The model, including all these previous variables, explained up to 29.4% of the observed variance. Male gender, older age, lower premorbid IQ, subdepressive symptoms, higher number of manic episodes, and lower performance in verbal memory, working memory, verbal fluency, and processing speed were associated with lower functioning in patients with BD. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Monitoring meteorological spatial variability in viticulture using a low-cost Wireless Sensor Network

NASA Astrophysics Data System (ADS)

Matese, Alessandro; Crisci, Alfonso; Di Gennaro, Filippo; Primicerio, Jacopo; Tomasi, Diego; Guidoni, Silvia

2014-05-01

In a long-term perspective, the current global agricultural scenario will be characterize by critical issues in terms of water resource management and environmental protection. The concept of sustainable agriculture would become crucial at reducing waste, optimizing the use of pesticides and fertilizers to crops real needs. This can be achieved through a minimum-scale monitoring of the crop physiologic status and the environmental parameters that characterize the microclimate. Viticulture is often subject to high variability within the same vineyard, thus becomes important to monitor this heterogeneity to allow a site-specific management and maximize the sustainability and quality of production. Meteorological variability expressed both at vineyard scale (mesoclimate) and at single plant level (microclimate) plays an important role during the grape ripening process. The aim of this work was to compare temperature, humidity and solar radiation measurements at different spatial scales. The measurements were assessed for two seasons (2011, 2012) in two vineyards of the Veneto region (North-East Italy), planted with Pinot gris and Cabernet Sauvignon using a specially designed and developed Wireless Sensor Network (WSN). The WSN consists of various levels: the Master/Gateway level coordinates the WSN and performs data aggregation; the Farm/Server level takes care of storing data on a server, data processing and graphic rendering. Nodes level is based on a network of peripheral nodes consisting of a sensor board equipped with sensors and wireless module. The system was able to monitor the agrometeorological parameters in the vineyard: solar radiation, air temperature and air humidity. Different sources of spatial variation were studied, from meso-scale to micro-scale. A widespread investigation was conducted, building a factorial design able to evidence the role played by any factor influencing the physical environment in the vineyard, such as the surrounding climate

Arden Syntax Clinical Foundation Framework for Event Monitoring in Intensive Care Units: Report on a Pilot Study.

PubMed

de Bruin, Jeroen S; Zeckl, Julia; Adlassnig, Katharina; Blacky, Alexander; Koller, Walter; Rappelsberger, Andrea; Adlassnig, Klaus-Peter

2017-01-01

The creation of clinical decision support systems has received a strong impulse over the last years, but their integration into a clinical routine has lagged behind, partly due to a lack of interoperability and trust by physicians. We report on the implementation of a clinical foundation framework in Arden Syntax, comprising knowledge units for (a) preprocessing raw clinical data, (b) the determination of single clinical concepts, and (c) more complex medical knowledge, which can be modeled through the composition and configuration of knowledge units in this framework. Thus, it can be tailored to clinical institutions or patients' caregivers. In the present version, we integrated knowledge units for several infection-related clinical concepts into the framework and developed a clinical event monitoring system over the framework that employs three different scenarios for monitoring clinical signs of bloodstream infection. The clinical event monitoring system was tested using data from intensive care units at Vienna General Hospital, Austria.

An update on insertable cardiac monitors: examining the latest clinical evidence and technology for arrhythmia management.

PubMed

Olsen, Flemming J; Biering-Sørensen, Tor; Krieger, Derk W

2015-05-01

Continuous cardiac rhythm monitoring has undergone compelling progress over the past decades. Cardiac monitoring has emerged from 12-lead electrocardiograms being performed at the discretion of the treating physician to in-hospital telemetry, Holter monitoring, prolonged external event monitoring and most recently toward insertable device monitoring for several years. Significant advantages and disadvantages pertaining to these monitoring options will be addressed in this review. Insertable cardiac monitors have several advantages over external monitoring techniques and may signify a clinical turning point in the field of arrhythmia management. However, their role in the detection of paroxysmal atrial fibrillation after cryptogenic strokes has yet to evolve. This will be the main focus of this review. Issues surrounding patient selection, clinical relevance and determination of cost-effectiveness for prolonged cardiac monitoring require further studies. Furthermore, insertable cardiac monitoring has not only the potential to augment diagnostic capabilities but also to improve the management of paroxysmal atrial fibrillation.

Guaranteeing robustness of structural condition monitoring to environmental variability

NASA Astrophysics Data System (ADS)

Van Buren, Kendra; Reilly, Jack; Neal, Kyle; Edwards, Harry; Hemez, François

2017-01-01

Advances in sensor deployment and computational modeling have allowed significant strides to be recently made in the field of Structural Health Monitoring (SHM). One widely used SHM strategy is to perform a vibration analysis where a model of the structure's pristine (undamaged) condition is compared with vibration response data collected from the physical structure. Discrepancies between model predictions and monitoring data can be interpreted as structural damage. Unfortunately, multiple sources of uncertainty must also be considered in the analysis, including environmental variability, unknown model functional forms, and unknown values of model parameters. Not accounting for these sources of uncertainty can lead to false-positives or false-negatives in the structural condition assessment. To manage the uncertainty, we propose a robust SHM methodology that combines three technologies. A time series algorithm is trained using "baseline" data to predict the vibration response, compare predictions to actual measurements collected on a potentially damaged structure, and calculate a user-defined damage indicator. The second technology handles the uncertainty present in the problem. An analysis of robustness is performed to propagate this uncertainty through the time series algorithm and obtain the corresponding bounds of variation of the damage indicator. The uncertainty description and robustness analysis are both inspired by the theory of info-gap decision-making. Lastly, an appropriate "size" of the uncertainty space is determined through physical experiments performed in laboratory conditions. Our hypothesis is that examining how the uncertainty space changes throughout time might lead to superior diagnostics of structural damage as compared to only monitoring the damage indicator. This methodology is applied to a portal frame structure to assess if the strategy holds promise for robust SHM. (Publication approved for unlimited, public release on October-28

Clinical Insight Into Latent Variables of Psychiatric Questionnaires for Mood Symptom Self-Assessment

PubMed Central

Saunders, Kate; Bilderbeck, Amy; Palmius, Niclas; Goodwin, Guy; De Vos, Maarten

2017-01-01

Background We recently described a new questionnaire to monitor mood called mood zoom (MZ). MZ comprises 6 items assessing mood symptoms on a 7-point Likert scale; we had previously used standard principal component analysis (PCA) to tentatively understand its properties, but the presence of multiple nonzero loadings obstructed the interpretation of its latent variables. Objective The aim of this study was to rigorously investigate the internal properties and latent variables of MZ using an algorithmic approach which may lead to more interpretable results than PCA. Additionally, we explored three other widely used psychiatric questionnaires to investigate latent variable structure similarities with MZ: (1) Altman self-rating mania scale (ASRM), assessing mania; (2) quick inventory of depressive symptomatology (QIDS) self-report, assessing depression; and (3) generalized anxiety disorder (7-item) (GAD-7), assessing anxiety. Methods We elicited responses from 131 participants: 48 bipolar disorder (BD), 32 borderline personality disorder (BPD), and 51 healthy controls (HC), collected longitudinally (median [interquartile range, IQR]: 363 [276] days). Participants were requested to complete ASRM, QIDS, and GAD-7 weekly (all 3 questionnaires were completed on the Web) and MZ daily (using a custom-based smartphone app). We applied sparse PCA (SPCA) to determine the latent variables for the four questionnaires, where a small subset of the original items contributes toward each latent variable. Results We found that MZ had great consistency across the three cohorts studied. Three main principal components were derived using SPCA, which can be tentatively interpreted as (1) anxiety and sadness, (2) positive affect, and (3) irritability. The MZ principal component comprising anxiety and sadness explains most of the variance in BD and BPD, whereas the positive affect of MZ explains most of the variance in HC. The latent variables in ASRM were identical for the patient groups

Prediction of hypertensive crisis based on average, variability and approximate entropy of 24-h ambulatory blood pressure monitoring.

PubMed

Schoenenberger, A W; Erne, P; Ammann, S; Perrig, M; Bürgi, U; Stuck, A E

2008-01-01

Approximate entropy (ApEn) of blood pressure (BP) can be easily measured based on software analysing 24-h ambulatory BP monitoring (ABPM), but the clinical value of this measure is unknown. In a prospective study we investigated whether ApEn of BP predicts, in addition to average and variability of BP, the risk of hypertensive crisis. In 57 patients with known hypertension we measured ApEn, average and variability of systolic and diastolic BP based on 24-h ABPM. Eight of these fifty-seven patients developed hypertensive crisis during follow-up (mean follow-up duration 726 days). In bivariate regression analysis, ApEn of systolic BP (P<0.01), average of systolic BP (P=0.02) and average of diastolic BP (P=0.03) were significant predictors of hypertensive crisis. The incidence rate ratio of hypertensive crisis was 14.0 (95% confidence interval (CI) 1.8, 631.5; P<0.01) for high ApEn of systolic BP as compared to low values. In multivariable regression analysis, ApEn of systolic (P=0.01) and average of diastolic BP (P<0.01) were independent predictors of hypertensive crisis. A combination of these two measures had a positive predictive value of 75%, and a negative predictive value of 91%, respectively. ApEn, combined with other measures of 24-h ABPM, is a potentially powerful predictor of hypertensive crisis. If confirmed in independent samples, these findings have major clinical implications since measures predicting the risk of hypertensive crisis define patients requiring intensive follow-up and intensified therapy.

Factors Associated with Blood Pressure Variability Based on Ambulatory Blood Pressure Monitoring in Subjects with Hypertension in China.

PubMed

Li, Wei; Yu, YanXia; Liang, Dehong; Jia, En-Zhi

2017-01-01

We examined the factors associated with blood pressure variability in a multi-ethnicity prospective study in China to gain more evidence to guide the prevention and management of hypertension through risk factor intervention. A total of 318 consecutive adult subjects aged 29-94 years with suspected or known hypertension were enrolled in this study. Blood pressure variability measurements were based on ambulatory blood pressure monitoring. To measure short-term reading-to-reading blood pressure variability in this study, we used the standard deviation(SD) of the blood pressure to estimate the blood pressure variability. The SDs of the blood pressure in this study ranged from 5.425 to 32.25, with a median of 10.81 (quartile range, 8.90-12.46). No significant difference regarding the level distribution of blood pressure variability was found across the various ethnicities. Spearman correlation analyses indicated that the SD of blood pressure was positively correlated with DSBP (r=0.302, p=<0.001), NSBP (r=0.383, p=<0.001), NDBP (r=0.230, p=<0.001), and FBG (r=0.129, p=0.023) and was negatively correlated with triglyceride (r=-0.289, p=<0.001), CR (r=-0.242, p=<0.001), HDL-C (r=-0.230, p=<0.001), LDL-C (r=-0.186, p=0.001), and apolipoprotein B levels (r=-0.157, p=0.006). Multiple linear regression analysis indicated that triglycerides (β=-0.217, p=<0.001), NSBP (β=0.174, p=0.003), FBG (β=0.128, p=0.024), DDBP (β=-0.128, p=0.022), and apolipoprotein A (β=-0.116, p=0.036) were significantly and independently associated with the blood pressure variability. In this study, blood pressure variability was significantly associated with not only blood pressure levels but also patient demographic, clinical and biochemical characteristics. © 2017 The Author(s). Published by S. Karger AG, Basel.

Advancing Continuous Predictive Analytics Monitoring: Moving from Implementation to Clinical Action in a Learning Health System.

PubMed

Keim-Malpass, Jessica; Kitzmiller, Rebecca R; Skeeles-Worley, Angela; Lindberg, Curt; Clark, Matthew T; Tai, Robert; Calland, James Forrest; Sullivan, Kevin; Randall Moorman, J; Anderson, Ruth A

2018-06-01

In the intensive care unit, clinicians monitor a diverse array of data inputs to detect early signs of impending clinical demise or improvement. Continuous predictive analytics monitoring synthesizes data from a variety of inputs into a risk estimate that clinicians can observe in a streaming environment. For this to be useful, clinicians must engage with the data in a way that makes sense for their clinical workflow in the context of a learning health system (LHS). This article describes the processes needed to evoke clinical action after initiation of continuous predictive analytics monitoring in an LHS. Copyright © 2018 Elsevier Inc. All rights reserved.

Current Opportunities for Clinical Monitoring of Axonal Pathology in Traumatic Brain Injury

PubMed Central

Tsitsopoulos, Parmenion P.; Abu Hamdeh, Sami; Marklund, Niklas

2017-01-01

Traumatic brain injury (TBI) is a multidimensional and highly complex disease commonly resulting in widespread injury to axons, due to rapid inertial acceleration/deceleration forces transmitted to the brain during impact. Axonal injury leads to brain network dysfunction, significantly contributing to cognitive and functional impairments frequently observed in TBI survivors. Diffuse axonal injury (DAI) is a clinical entity suggested by impaired level of consciousness and coma on clinical examination and characterized by widespread injury to the hemispheric white matter tracts, the corpus callosum and the brain stem. The clinical course of DAI is commonly unpredictable and it remains a challenging entity with limited therapeutic options, to date. Although axonal integrity may be disrupted at impact, the majority of axonal pathology evolves over time, resulting from delayed activation of complex intracellular biochemical cascades. Activation of these secondary biochemical pathways may lead to axonal transection, named secondary axotomy, and be responsible for the clinical decline of DAI patients. Advances in the neurocritical care of TBI patients have been achieved by refinements in multimodality monitoring for prevention and early detection of secondary injury factors, which can be applied also to DAI. There is an emerging role for biomarkers in blood, cerebrospinal fluid, and interstitial fluid using microdialysis in the evaluation of axonal injury in TBI. These biomarker studies have assessed various axonal and neuroglial markers as well as inflammatory mediators, such as cytokines and chemokines. Moreover, modern neuroimaging can detect subtle or overt DAI/white matter changes in diffuse TBI patients across all injury severities using magnetic resonance spectroscopy, diffusion tensor imaging, and positron emission tomography. Importantly, serial neuroimaging studies provide evidence for evolving axonal injury. Since axonal injury may be a key risk factor for

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

Variability and periodicity of field M dwarfs revealed by multichannel monitoring

NASA Astrophysics Data System (ADS)

Rockenfeller, B.; Bailer-Jones, C. A. L.; Mundt, R.

2006-03-01

We present simultaneous, multiband photometric monitoring of 19 field dwarfs covering most of the M spectral sequence (M2-M9). Significant variability was found in seven objects in at least one out of the three channels I, R and G. Periodic variability was tested with a CLEAN power spectral analysis. Two objects, LHS370 (M5V) and 2M1707+64 (M9V), show periods of 5.9± 2.0 and 3.65± 0.1 h respectively. On account of the agreement with the typical values of v sin i published for M dwarfs (Mohanty & Basri 2003, ApJ, 583, 451), we claim these to be the objects' rotation periods. Three further objects show possible periods of a few hours. Comparing the variability amplitude in each channel with predictions based on the synthetic spectra of Allard et al. (2001, ApJ, 556, 357), we investigated the source of variability in LHS370 and 2M1707+64. For the latter, we find evidence for the presence of magnetically-induced cool spots at a temperature contrast of 4-8%, with a projected surface coverage factor of less than 0.075. Moreover, we can rule out dust clouds (as represented by the COND or DUSTY models) as the cause of the variability. No conclusion can be drawn in the case of LHS370. Comparing the frequency of occurrence of variability in this and various L dwarf samples published over the past few years, we find that variability is more common in field L dwarfs than in field M dwarfs (for amplitudes larger than 0.005 mag on timescales of 0.5 to 20 h). Using the homogeneous data sets of this work and Bailer-Jones & Mundt (2001, A&A, 367, 218), we find fractions of variable objects of 0.21± 0.11 among field M dwarfs and 0.70± 0.26 among field L dwarfs (and 0.29± 0.13, 0.48± 0.12 respectively if we take into account a larger yet more inhomogeneous sample). This is marginally significant (2σ deviation) and implies a change in the physical nature and/or extent of surface features when moving from M to L dwarfs.

Variability in CKD stage in outpatients followed in two large renal clinics.

PubMed

Sikaneta, Tabo; Abdolell, Mohamed; Taskapan, Hulya; Roscoe, Janet; Fung, Jason; Nagai, Gordon; Ting, Robert H; Ng, Paul; Wu, George; Oreopoulos, Dimitrios; Tam, Paul Y

2012-10-01

Chronic kidney disease (CKD) is staged by glomerular filtration rate (GFR). CKD stages sometimes vary between routine office visits, and it is unknown if this impacts renal and patient survival separately from a cross-sectional CKD stage value. We quantified and categorized CKD stage variability in a large group of outpatients and correlated this with clinical and demographic features and with renal and patient survival. All estimated GFRs were staged in the first observation period. CKD stages were then categorized as static, improving, worsening, or fluctuating. Logistic regression analysis was performed to identify clinical variables associated with CKD stage variability. Death and dialysis progression rates were then collected and analyzed using Cox proportional regression. During a 1.1-year observation period, 1,262 patients (mean age 71.25 years) had a mean 5 eGFR's. CKD stages were static in 60.4%, worsened in 14.4%, improved in 7.4%, and fluctuated in 17.2% of patients. Secondary analysis revealed heavy proteinuria and East Asian ethnicity to be negatively, and diabetes mellitus and previous acute kidney injury to be positively associated with improving CKD stages. Cox proportional regression of 902 patients analyzed 2.3 years later revealed a negative association with improving CKD stage and subsequent need for dialysis. CKD stage changed in 40% of 1,262 elderly patients when determined 5 times in just over 1 year. Improving CKD stage was the only variability pattern significantly associated with any of the clinical outcomes when assessed 2.3 years later, being unlikely to be linked with subsequent need for dialysis.

Implantable cardiac resynchronization therapy devices to monitor heart failure clinical status.

PubMed

Fung, Jeffrey Wing-Hong; Yu, Cheuk-Man

2007-03-01

Cardiac resynchronization therapy is a standard therapy for selected patients with heart failure. With advances in technology and storage capacity, the device acts as a convenient platform to provide valuable information about heart failure status in these high-risk patients. Unlike other modalities of investigation which may only allow one-off evaluation, heart failure status can be monitored by device diagnostics including heart rate variability, activity status, and intrathoracic impedance in a continuous basis. These parameters do not just provide long-term prognostic information but also may be useful to predict upcoming heart failure exacerbation. Prompt and early intervention may abort decompensation, prevent hospitalization, improve quality of life, and reduce health care cost. Moreover, this information may be applied to titrate the dosage of medication and monitor response to heart failure treatment. This review will focus on the prognostic and predictive values of heart failure status monitoring provided by these devices.

Use of continuous glucose monitoring as an outcome measure in clinical trials.

PubMed

Beck, Roy W; Calhoun, Peter; Kollman, Craig

2012-10-01

Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian(®) [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5-57 years; mean, 18 ± 12 years). Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P = 0.92), and the correlation of the two was high (r = 0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P = 0.05] and 262 mg/dL vs. 257 mg/dL [P = 0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001). A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials.

Real-time monitoring of clinical processes using complex event processing and transition systems.

PubMed

Meinecke, Sebastian

2014-01-01

Dependencies between tasks in clinical processes are often complex and error-prone. Our aim is to describe a new approach for the automatic derivation of clinical events identified via the behaviour of IT systems using Complex Event Processing. Furthermore we map these events on transition systems to monitor crucial clinical processes in real-time for preventing and detecting erroneous situations.

Monitoring of HIV viral load, CD4 cell count, and clinical assessment versus clinical monitoring alone for antiretroviral therapy in low-resource settings (Stratall ANRS 12110/ESTHER): a cost-effectiveness analysis.

PubMed

Boyer, Sylvie; March, Laura; Kouanfack, Charles; Laborde-Balen, Gabrièle; Marino, Patricia; Aghokeng, Avelin Fobang; Mpoudi-Ngole, Eitel; Koulla-Shiro, Sinata; Delaporte, Eric; Carrieri, Maria Patrizia; Spire, Bruno; Laurent, Christian; Moatti, Jean-Paul

2013-07-01

In low-income countries, the use of laboratory monitoring of patients taking antiretroviral therapy (ART) remains controversial in view of persistent resource constraints. The Stratall trial did not show that clinical monitoring alone was non-inferior to laboratory and clinical monitoring in terms of immunological recovery. We aimed to evaluate the costs and cost-effectiveness of the ART monitoring approaches assessed in the Stratall trial. The randomised, controlled, non-inferiority Stratall trial was done in a decentralised setting in Cameroon. Between May 23, 2006, and Jan 31, 2008, ART-naive adults were randomly assigned (1:1) to clinical monitoring (CLIN) or viral load and CD4 cell count plus clinical monitoring (LAB) and followed up for 24 months. We calculated costs, number of life-years saved (LYS), and incremental cost-effectiveness ratios (ICERs) with data from patients who had been followed up for at least 6 months. We considered two cost scenarios in which viral load plus CD4 cell count tests cost either US$95 (scenario 1; Abbott RealTime HIV-1 assay) or $63 (scenario 2; generic assay). We compared ICERs with a WHO-recommended threshold of three times the per-person gross domestic product (GDP) for Cameroon ($3670-3800) and an alternative lower threshold of $2385 to determine cost-effectiveness. We assessed uncertainty with one-way sensitivity analyses and cost-effectiveness acceptability curves. 188 participants who underwent LAB and 197 who underwent CLIN were followed up for at least 6 months. In scenario 1, LAB increased costs by a mean of $489 (SD 430) per patient and saved 0·103 life-years compared with CLIN (ICER of $4768 [95% CI 3926-5613] per LYS). In scenario 2, the incremental mean cost of LAB was $343 (SD 425) -ie, an ICER of $3339 (2507-4173) per LYS. A combined strategy in which LAB would only be used in patients starting ART with a CD4 count of 200 cells per μL or fewer suggests that 0·120 life-years would be saved at an additional

Clinical periodontal variables in patients with and without dementia-a systematic review and meta-analysis.

PubMed

Maldonado, Alejandra; Laugisch, Oliver; Bürgin, Walter; Sculean, Anton; Eick, Sigrun

2018-06-22

Considering the increasing number of elderly people, dementia has gained an important role in today's society. Although the contributing factors for dementia have not been fully understood, chronic periodontitis (CP) seems to have a possible link to dementia. To conduct a systematic review including meta-analysis in order to assess potential differences in clinical periodontal variables between patients with dementia and non-demented individuals. The following focused question was evaluated: is periodontitis associated with dementia? Electronic searches in two databases, MEDLINE and EMBASE, were conducted. Meta-analysis was performed with the collected data in order to find a statistically significant difference in clinical periodontal variables between the group of dementia and the cognitive normal controls. Forty-two articles remained for full text reading. Finally, seven articles met the inclusion criteria and only five studies provided data suitable for meta-analysis. Periodontal probing depth (PPD), bleeding on probing (BOP), gingival bleeding index (GBI), clinical attachment level (CAL), and plaque index (PI) were included as periodontal variables in the meta-analysis. Each variable revealed a statistically significant difference between the groups. In an attempt to reveal an overall difference between the periodontal variables in dementia patients and non-demented individuals, the chosen variables were transformed into units that resulted in a statistically significant overall difference (p < 0.00001). The current findings indicate that compared to systemically healthy individuals, demented patients show significantly worse clinical periodontal variables. However, further epidemiological studies including a high numbers of participants, the use of exact definitions both for dementia and chronic periodontitis and adjusted for cofounders is warranted. These findings appear to support the putative link between CP and dementia. Consequently, the need for

Role of Ambulatory and Home Blood Pressure Monitoring in Clinical Practice: A Narrative Review

PubMed Central

Shimbo, Daichi; Abdalla, Marwah; Falzon, Louise; Townsend, Raymond R.; Muntner, Paul

2015-01-01

Hypertension, a common cardiovascular disease (CVD) risk factor, is usually diagnosed and treated based on blood pressure readings obtained in the clinic setting. Blood pressure may differ considerably when measured in the clinic versus outside of the clinic setting. Over the past several decades, evidence has accumulated on two approaches for measuring out-of-clinic blood pressure: ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM). Blood pressure measures on ABPM and HBPM each have a stronger association with CVD outcomes than clinic blood pressure. Controversy exists whether ABPM or HBPM is superior for estimating CVD risk, and under what circumstances these methods should be used in clinical practice for assessing out-of-clinic blood pressure. This review describes ABPM and HBPM procedures, the blood pressure phenotypic measures that can be ascertained, and the evidence that supports the use of each approach to measure out-of-clinic blood pressure. This review also describes barriers to the successful implementation of ABPM and HBPM in clinical practice, proposes core competencies for the conduct of these procedures, and highlights important areas for future research. PMID:26457954

Classification of Variable Objects in Massive Sky Monitoring Surveys

NASA Astrophysics Data System (ADS)

Woźniak, Przemek; Wyrzykowski, Łukasz; Belokurov, Vasily

2012-03-01

The era of great sky surveys is upon us. Over the past decade we have seen rapid progress toward a continuous photometric record of the optical sky. Numerous sky surveys are discovering and monitoring variable objects by hundreds of thousands. Advances in detector, computing, and networking technology are driving applications of all shapes and sizes ranging from small all sky monitors, through networks of robotic telescopes of modest size, to big glass facilities equipped with giga-pixel CCD mosaics. The Large Synoptic Survey Telescope will be the first peta-scale astronomical survey [18]. It will expand the volume of the parameter space available to us by three orders of magnitude and explore the mutable heavens down to an unprecedented level of sensitivity. Proliferation of large, multidimensional astronomical data sets is stimulating the work on new methods and tools to handle the identification and classification challenge [3]. Given exponentially growing data rates, automated classification of variability types is quickly becoming a necessity. Taking humans out of the loop not only eliminates the subjective nature of visual classification, but is also an enabling factor for time-critical applications. Full automation is especially important for studies of explosive phenomena such as γ-ray bursts that require rapid follow-up observations before the event is over. While there is a general consensus that machine learning will provide a viable solution, the available algorithmic toolbox remains underutilized in astronomy by comparison with other fields such as genomics or market research. Part of the problem is the nature of astronomical data sets that tend to be dominated by a variety of irregularities. Not all algorithms can handle gracefully uneven time sampling, missing features, or sparsely populated high-dimensional spaces. More sophisticated algorithms and better tools available in standard software packages are required to facilitate the adoption of

Episiotomy and its relationship to various clinical variables that influence its performance

PubMed Central

Ballesteros-Meseguer, Carmen; Carrillo-García, César; Meseguer-de-Pedro, Mariano; Canteras-Jordana, Manuel; Martínez-Roche, Mª Emilia

2016-01-01

Objective: to understand the episiotomy rate and its relationship with various clinical variables. Method: a descriptive, cross-sectional, analytic study of 12,093 births in a tertiary hospital. Variables: Parity, gestational age, start of labor, use of epidural analgesia, oxytocin usage, position during fetal explusion, weight of neonate, and completion of birth. The analysis was performed with SPSS 19.0. Results: the global percentage of episiotomies was 50%. The clinical variables that presented a significant association were primiparity (RR=2.98), gestational age >41 weeks (RR=1.2), augmented or induced labor (RR=1.33), epidural analgesia use (RR=1,95), oxytocin use (RR=1.58), lithotomy position during fetal expulsion (RR=6.4), and instrumentation (RR=1.84). Furthermore, maternal age ≥35 years (RR=0.85) and neonatal weight <2500 g (RR=0.8) were associated with a lower incidence of episiotomy. Conclusions: episiotomy is dependent on obstetric interventions performed during labor. If we wish to reduce the episiotomy rate, it will be necessary to bear in mind these risk factors when establishing policies for reducing this procedure. PMID:27224064

The impacts of a pharmacist-managed outpatient clinic and chemotherapy-directed electronic order sets for monitoring oral chemotherapy.

PubMed

Battis, Brandon; Clifford, Linda; Huq, Mostaqul; Pejoro, Edrick; Mambourg, Scott

2017-12-01

Objectives Patients treated with oral chemotherapy appear to have less contact with the treating providers. As a result, safety, adherence, medication therapy monitoring, and timely follow-up may be compromised. The trend of treating cancer with oral chemotherapy agents is on the rise. However, standard clinical guidance is still lacking for prescribing, monitoring, patient education, and follow-up of patients on oral chemotherapy across the healthcare settings. The purpose of this project is to establish an oral chemotherapy monitoring clinic, to create drug and lab specific provider order sets for prescribing and lab monitoring, and ultimately to ensure safe and effective treatment of the veterans we serve. Methods A collaborative agreement was reached among oncology pharmacists, a pharmacy resident, two oncologists, and a physician assistant to establish a pharmacist-managed oral chemotherapy monitoring clinic at the VA Sierra Nevada Healthcare System. Drug-specific electronic order sets for prescribing and lab monitoring were created for initiating new drug therapy and prescription renewal. The order sets were created to be provider-centric, minimizing clicks needed to order necessary medications and lab monitoring. A standard progress note template was developed for documenting interventions made by the clinic. Patients new to an oral chemotherapy regimen were first counseled by an oncology pharmacist. The patients were then enrolled into the oral chemotherapy monitoring clinic for subsequent follow up and pharmacist interventions. Further, patients lacking monitoring or missing provider appointments were captured through a Clinical Dashboard developed by the US Department of Veterans Affairs (VA) Regional Office (VISN21) using SQL Server Reporting Services. Between September 2014 and April 2015, a total of 68 patients on different oral chemotherapy agents were enrolled into the clinic. Results Out of the 68 patients enrolled into the oral chemotherapy

Is it me? Verbal self-monitoring neural network and clinical insight in schizophrenia

PubMed Central

Sapara, Adegboyega; ffytche, Dominic H.; Cooke, Michael A.; Williams, Steven C.R.; Kumari, Veena

2015-01-01

Self-monitoring, defined as the ability to distinguish between self-generated stimuli from other-generated ones, is known to be impaired in schizophrenia. This impairment has been theorised as the basis for many of the core psychotic symptoms, in particular, poor clinical insight. This study aimed to investigate verbal self-monitoring related neural substrates of preserved and poor clinical insight in schizophrenia. It involved 40 stable schizophrenia outpatients, 20 with preserved and 20 with poor insight, and 20 healthy participants. All participants underwent functional magnetic resonance imaging with brain coverage covering key areas in the self-monitoring network during a verbal self-monitoring task. Healthy participants showed higher performance accuracy and greater thalamic activity than both preserved and poor insight patient groups. Preserved insight patients showed higher activity in the putamen extending into the caudate, insula and inferior frontal gyrus, compared to poor insight patients, and in the anterior cingulate and medial frontal gyrus, compared to healthy participants. Poor insight patients did not show greater activity in any brain area compared to preserved insight patients or healthy participants. Future studies may pursue therapeutic avenues, such as meta-cognitive therapies to promote self-monitoring or targeted stimulation of relevant brain areas, as means of enhancing insight in schizophrenia. PMID:26549744

Monitoring worksite clinic performance using a cost-benefit tool.

PubMed

Tao, Xuguang; Chenoweth, David; Alfriend, Amy S; Baron, David M; Kirkland, Tracie W; Scherb, Jill; Bernacki, Edward J

2009-10-01

The purpose of this study was to explore the usefulness of continuously assessing the return on investment (ROI) of worksite medical clinics as a means of evaluating clinic performance. Visit data from January 1, 2007, to December 31, 2008, were collected from all the on-site clinics operated for the Pepsi Bottling Group. An average system-wide ROI was calculated from the time of each clinic's opening and throughout the study period. A multivariate linear regression model was used to determine the association of average ROI with penetration/utilization rate and plant size. A total of 26 on-site clinics were actively running as of December 2008. The average ROI at the time of start up was 0.4, which increased to 1.2 at approximately 4 months and 1.6 at the end of the first year of operation. Overall, it seems that the cost of operating a clinic becomes equal to the cost of similar care purchased in the community (ROI = 1) at approximately 3 months after a clinic's opening and flattens out at the end of the first year. The magnitude of the ROI was closely related to the number of visits (a function of the penetration/utilization rate) and the size of the plant population served. Serial monitoring of ROIs is a useful metric in assessing on-site clinic performance and quantifying the effect of new initiatives aimed at increasing a clinic's cost effectiveness.

Methodology and technology for peripheral and central blood pressure and blood pressure variability measurement: current status and future directions - Position statement of the European Society of Hypertension Working Group on blood pressure monitoring and cardiovascular variability.

PubMed

Stergiou, George S; Parati, Gianfranco; Vlachopoulos, Charalambos; Achimastos, Apostolos; Andreadis, Emanouel; Asmar, Roland; Avolio, Alberto; Benetos, Athanase; Bilo, Grzegorz; Boubouchairopoulou, Nadia; Boutouyrie, Pierre; Castiglioni, Paolo; de la Sierra, Alejandro; Dolan, Eamon; Head, Geoffrey; Imai, Yutaka; Kario, Kazuomi; Kollias, Anastasios; Kotsis, Vasilis; Manios, Efstathios; McManus, Richard; Mengden, Thomas; Mihailidou, Anastasia; Myers, Martin; Niiranen, Teemu; Ochoa, Juan Eugenio; Ohkubo, Takayoshi; Omboni, Stefano; Padfield, Paul; Palatini, Paolo; Papaioannou, Theodore; Protogerou, Athanasios; Redon, Josep; Verdecchia, Paolo; Wang, Jiguang; Zanchetti, Alberto; Mancia, Giuseppe; O'Brien, Eoin

2016-09-01

Office blood pressure measurement has been the basis for hypertension evaluation for almost a century. However, the evaluation of blood pressure out of the office using ambulatory or self-home monitoring is now strongly recommended for the accurate diagnosis in many, if not all, cases with suspected hypertension. Moreover, there is evidence that the variability of blood pressure might offer prognostic information that is independent of the average blood pressure level. Recently, advancement in technology has provided noninvasive evaluation of central (aortic) blood pressure, which might have attributes that are additive to the conventional brachial blood pressure measurement. This position statement, developed by international experts, deals with key research and practical issues in regard to peripheral blood pressure measurement (office, home, and ambulatory), blood pressure variability, and central blood pressure measurement. The objective is to present current achievements, identify gaps in knowledge and issues concerning clinical application, and present relevant research questions and directions to investigators and manufacturers for future research and development (primary goal).

Assessing national provision of care: variability in bariatric clinical care pathways.

PubMed

Telem, Dana A; Majid, Saniea F; Powers, Kinga; DeMaria, Eric; Morton, John; Jones, Daniel B

2017-02-01

The American Society for Metabolic and Bariatric Surgery (ASMBS) Quality Improvement and Patient Safety (QIPS) Committee hypothesized that collecting and sharing clinical pathways could provide a valuable resource to new and existing bariatric programs. To shed light on the variability in practice patterns across the country by analyzing pathways. United States Centers of Excellence METHODS: From June 2014 to April 2015, clinical pathways pertaining to preoperative, intraoperative, and postoperative management of bariatric patients were solicited from the ASMBS executive council (EC), QIPS committee members, and state chapter presidents. Pathways were de-identified and then analyzed based on predetermined metrics pertaining to preoperative, intraoperative, and postoperative care. Concordance and discordance were then analyzed. In total, 31 pathways were collected; response rate was 80% from the EC, 77% from the QIPS committee, and 21% from state chapter presidents. The number of pathways sent in ranged from 1 to 10 with a median of 3 pathways per individual or institution. The majority of pathways centered on perioperative care (80%). Binary assessment (presence or absence) of variables found a high concordance (defined by greater than 65% of pathways accounting for that parameter) in only 6 variables: nutritional evaluation, psychological evaluation, intraoperative venous thromboembolism (VTE) prophylaxis, utilization of antiemetics in the postoperative period, a dedicated pain pathway, and postoperative laboratory evaluation. There is considerable national variation in clinical pathways among practicing bariatric surgeons. Most pathways center on Metabolic and Bariatric Surgery Accredited Quality Improvement Program (MBSAQIP) accreditation parameters, patient satisfaction, or Surgical Care Improvement Protocol (SCIP) measures. These pathways provide a path toward standardization of improved care. Copyright © 2016. Published by Elsevier Inc.

Nitrate variability in groundwater of North Carolina using monitoring and private well data models.

PubMed

Messier, Kyle P; Kane, Evan; Bolich, Rick; Serre, Marc L

2014-09-16

Nitrate (NO3-) is a widespread contaminant of groundwater and surface water across the United States that has deleterious effects to human and ecological health. This study develops a model for predicting point-level groundwater NO3- at a state scale for monitoring wells and private wells of North Carolina. A land use regression (LUR) model selection procedure is developed for determining nonlinear model explanatory variables when they are known to be correlated. Bayesian Maximum Entropy (BME) is used to integrate the LUR model to create a LUR-BME model of spatial/temporal varying groundwater NO3- concentrations. LUR-BME results in a leave-one-out cross-validation r2 of 0.74 and 0.33 for monitoring and private wells, effectively predicting within spatial covariance ranges. Results show significant differences in the spatial distribution of groundwater NO3- contamination in monitoring versus private wells; high NO3- concentrations in the southeastern plains of North Carolina; and wastewater treatment residuals and swine confined animal feeding operations as local sources of NO3- in monitoring wells. Results are of interest to agencies that regulate drinking water sources or monitor health outcomes from ingestion of drinking water. Lastly, LUR-BME model estimates can be integrated into surface water models for more accurate management of nonpoint sources of nitrogen.

Risk-adjusted monitoring of survival times

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sego, Landon H.; Reynolds, Marion R.; Woodall, William H.

2009-02-26

We consider the monitoring of clinical outcomes, where each patient has a di®erent risk of death prior to undergoing a health care procedure.We propose a risk-adjusted survival time CUSUM chart (RAST CUSUM) for monitoring clinical outcomes where the primary endpoint is a continuous, time-to-event variable that may be right censored. Risk adjustment is accomplished using accelerated failure time regression models. We compare the average run length performance of the RAST CUSUM chart to the risk-adjusted Bernoulli CUSUM chart, using data from cardiac surgeries to motivate the details of the comparison. The comparisons show that the RAST CUSUM chart is moremore » efficient at detecting a sudden decrease in the odds of death than the risk-adjusted Bernoulli CUSUM chart, especially when the fraction of censored observations is not too high. We also discuss the implementation of a prospective monitoring scheme using the RAST CUSUM chart.« less

Low heart rate variability in patients with clinical burnout.

PubMed

Lennartsson, Anna-Karin; Jonsdottir, Ingibjörg; Sjörs, Anna

2016-12-01

Several studies have shown that acute psychosocial stress and chronic psychosocial stress reduce heart rate variability (HRV). It is likely that individuals suffering from burnout have reduced HRV, as a consequence of the long-term stress exposure. This study investigated HRV in 54 patients with clinical burnout (40 women and 14 men) and in 55 individuals reporting low burnout scores (healthy; 24 women and 31 men) and 52 individuals reporting high burnout scores (non-clinical burnout; 33 women and 19 men). The participants underwent a 300s ECG recording in the supine position. Standard deviation of normal R-R intervals (SDNN) and the root mean square of successive normal interval differences (RMSSD) were derived from time domain HRV analysis. Frequency domain HRV measures; total power (TP), low frequency power (LF), high frequency power (HF), and LF/HF ratio were calculated. All HRV measures, except LF/HF ratio, were lower in the clinical burnout patients compared to both the non-clinical burnout group and the healthy group. The difference was larger between the patients and the healthy group than between the patients and the non-clinical burnout group. HRV did not differ significantly between the non-clinical burnout group and the healthy group. Low HRV in burnout patients may constitute one of the links to associated adverse health, since low HRV reflects low parasympathetic activity - and accordingly low anabolic/regenerative activity. Copyright © 2016 Elsevier B.V. All rights reserved.

How Should Remote Clinical Monitoring Be Used to Treat Alcohol Use Disorders?: Initial Findings From an Expert Round Table Discussion.

PubMed

Gordon, Alan; Jaffe, Adi; McLellan, A Thomas; Richardson, Gary; Skipper, Gregory; Sucher, Michel; Tirado, Carlos F; Urschel, Harold C

Scientific evidence combined with new health insurance coverage now enable a chronic illness management approach to the treatment of alcohol use disorders (AUDs), including regular monitoring of blood alcohol content (BAC), as a useful indicator of disease control. Recent technical advances now permit many different types of remote, real-time monitoring of BAC. However, there is no body of research to empirically guide clinicians in how to maximize the clinical potential of remote BAC monitoring.As an initial step in guiding and supporting such research, the manufacturer of one remote BAC monitoring system sponsored a group of experienced clinicians and clinical researchers to discuss 8 issues that generally affect remote, clinical BAC monitoring of "adults in outpatient AUD treatment."The expert panel unanimously agreed that remote BAC monitoring for at least 12 months during and after the outpatient treatment of AUD was a clinically viable deterrent to relapse. There was also consensus that positive test results (ie, recent alcohol use) should lead to intensified care and monitoring. However, there was no agreement on specific types of clinical intensification after a positive test. The panel agreed that sharing positive and negative test results with members of the patient support group was helpful in reinforcing abstinence, yet they noted many practical issues regarding information sharing that remain concerning. Significant differences within the panel on several important clinical issues underline the need for more clinical and implementation research to produce empirically-supported guidelines for the use of remote BAC monitoring in AUD treatment.

How Should Remote Clinical Monitoring Be Used to Treat Alcohol Use Disorders?: Initial Findings From an Expert Round Table Discussion

PubMed Central

Gordon, Alan; Jaffe, Adi; McLellan, A. Thomas; Richardson, Gary; Skipper, Gregory; Sucher, Michel; Tirado, Carlos F.; Urschel, Harold C.

2017-01-01

Scientific evidence combined with new health insurance coverage now enable a chronic illness management approach to the treatment of alcohol use disorders (AUDs), including regular monitoring of blood alcohol content (BAC), as a useful indicator of disease control. Recent technical advances now permit many different types of remote, real-time monitoring of BAC. However, there is no body of research to empirically guide clinicians in how to maximize the clinical potential of remote BAC monitoring. As an initial step in guiding and supporting such research, the manufacturer of one remote BAC monitoring system sponsored a group of experienced clinicians and clinical researchers to discuss 8 issues that generally affect remote, clinical BAC monitoring of “adults in outpatient AUD treatment.” The expert panel unanimously agreed that remote BAC monitoring for at least 12 months during and after the outpatient treatment of AUD was a clinically viable deterrent to relapse. There was also consensus that positive test results (ie, recent alcohol use) should lead to intensified care and monitoring. However, there was no agreement on specific types of clinical intensification after a positive test. The panel agreed that sharing positive and negative test results with members of the patient support group was helpful in reinforcing abstinence, yet they noted many practical issues regarding information sharing that remain concerning. Significant differences within the panel on several important clinical issues underline the need for more clinical and implementation research to produce empirically-supported guidelines for the use of remote BAC monitoring in AUD treatment. PMID:28157829

Combination of process and vibration data for improved condition monitoring of industrial systems working under variable operating conditions

NASA Astrophysics Data System (ADS)

Ruiz-Cárcel, C.; Jaramillo, V. H.; Mba, D.; Ottewill, J. R.; Cao, Y.

2016-01-01

The detection and diagnosis of faults in industrial processes is a very active field of research due to the reduction in maintenance costs achieved by the implementation of process monitoring algorithms such as Principal Component Analysis, Partial Least Squares or more recently Canonical Variate Analysis (CVA). Typically the condition of rotating machinery is monitored separately using vibration analysis or other specific techniques. Conventional vibration-based condition monitoring techniques are based on the tracking of key features observed in the measured signal. Typically steady-state loading conditions are required to ensure consistency between measurements. In this paper, a technique based on merging process and vibration data is proposed with the objective of improving the detection of mechanical faults in industrial systems working under variable operating conditions. The capabilities of CVA for detection and diagnosis of faults were tested using experimental data acquired from a compressor test rig where different process faults were introduced. Results suggest that the combination of process and vibration data can effectively improve the detectability of mechanical faults in systems working under variable operating conditions.

Clinical utility of EEG in diagnosing and monitoring epilepsy in adults.

PubMed

Tatum, W O; Rubboli, G; Kaplan, P W; Mirsatari, S M; Radhakrishnan, K; Gloss, D; Caboclo, L O; Drislane, F W; Koutroumanidis, M; Schomer, D L; Kasteleijn-Nolst Trenite, D; Cook, Mark; Beniczky, S

2018-05-01

Electroencephalography (EEG) remains an essential diagnostic tool for people with epilepsy (PWE). The International Federation of Clinical Neurophysiology produces new guidelines as an educational service for clinicians to address gaps in knowledge in clinical neurophysiology. The current guideline was prepared in response to gaps present in epilepsy-related neurophysiological assessment and is not intended to replace sound clinical judgement in the care of PWE. Furthermore, addressing specific pathophysiological conditions of the brain that produce epilepsy is of primary importance though is beyond the scope of this guideline. Instead, our goal is to summarize the scientific evidence for the utility of EEG when diagnosing and monitoring PWE. Copyright © 2018 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Microdialysis Monitoring in Clinical Traumatic Brain Injury and Its Role in Neuroprotective Drug Development.

PubMed

Thelin, Eric Peter; Carpenter, Keri L H; Hutchinson, Peter J; Helmy, Adel

2017-03-01

Injuries to the central nervous system continue to be vast contributors to morbidity and mortality; specifically, traumatic brain injury (TBI) is the most common cause of death during the first four decades of life. Several modalities are used to monitor patients suffering from TBI in order to prevent detrimental secondary injuries. The microdialysis (MD) technique, introduced during the 1990s, presents the treating physician with a robust monitoring tool for brain chemistry in addition to conventional intracranial pressure monitoring. Nevertheless, some limitations remain, such as limited spatial resolution. Moreover, while there have been several attempts to develop new potential pharmacological therapies in TBI, there are currently no available drugs which have shown clinical efficacy that targets the underlying pathophysiology, despite various trials investigating a plethora of pharmaceuticals. Specifically in the brain, MD is able to demonstrate penetration of the drug through the blood-brain barrier into the brain extracellular space at potential site of action. In addition, the downstream effects of drug action can be monitored directly. In the future, clinical MD, together with other monitoring modalities, can identify specific pathological substrates which require tailored treatment strategies for patients suffering from TBI.

Use of Continuous Glucose Monitoring as an Outcome Measure in Clinical Trials

PubMed Central

Calhoun, Peter; Kollman, Craig

2012-01-01

Abstract Objective Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Research Design and Methods Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian® [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5–57 years; mean, 18±12 years). Results Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P=0.92), and the correlation of the two was high (r=0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P=0.05] and 262 mg/dL vs. 257 mg/dL [P=0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001). Conclusions A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials. PMID:23013201

Understanding of safety monitoring in clinical trials by individuals with CF or their parents: A qualitative analysis.

PubMed

Kern-Goldberger, Andrew S; Hessels, Amanda J; Saiman, Lisa; Quittell, Lynne M

2018-03-14

Recruiting both pediatric and adult participants for clinical trials in CF is currently of paramount importance as numerous new therapies are being developed. However, recruitment is challenging as parents of children with CF and adults with CF cite safety concerns as a principal barrier to enrollment. In conjunction with the CF Foundation (CFF) Data Safety Monitoring Board (DSMB), a pilot brochure was developed to inform patients and parents of the multiple levels of safety monitoring; the CFF simultaneously created an infographic representing the safety monitoring process. This study explores the attitudes and beliefs of CF patients and families regarding safety monitoring and clinical trial participation, and elicits feedback regarding the educational materials. Semi-structured interviews were conducted using a pre-tested interview guide and audio-recorded during routine CF clinic visits. Participants included 5 parents of children with CF <16years old; 5 adolescents and young adults with CF 16-21years old; and 5 adults with CF ≥22years old from pediatric and adult CF centers. The study team performed systematic text condensation analysis of the recorded interviews using an iterative process. Four major thematic categories with subthemes emerged as supported by exemplar quotations: attitudes toward clinical trials, safety values, conceptualizing the safety monitoring process, and priorities for delivery of patient education. Participant feedback was used to revise the pilot brochure; text was shortened, unfamiliar words clarified (e.g., "pipeline"), abbreviations eliminated, and redundancy avoided. Qualitative analysis of CF patient and family interviews provided insights into barriers to participation in clinical trials, safety concerns, perspectives on safety monitoring and educational priorities. We plan a multicenter study to determine if the revised brochure reduces knowledge, attitude and practice barriers regarding participation in CF clinical trials

Therapeutic Drug Monitoring in Children and Adolescents Under Pharmacotherapy With Olanzapine in Daily Clinical Practice.

PubMed

Fekete, Stefanie; Wewetzer, Christoph; Mehler-Wex, Claudia; Holtkamp, Kristian; Burger, Rainer; Reichert, Susanne; Taurines, Regina; Romanos, Marcel; Gerlach, Manfred; Egberts, Karin

2017-06-01

The relationship between daily dose, serum concentrations, and clinical outcomes of olanzapine as well as the influencing factors thereof in children and adolescents treated for different psychiatric disorders were investigated in daily clinical practice. In addition, it was examined whether the current recommended therapeutic range (TR) for adult patients with psychotic disorders is valid for minors. The Competence Network for Therapeutic Drug Monitoring (www.tdm-kjp.com) routinely collects demographic and clinical outcome data as well as serum concentrations of children and adolescents treated with psychotropics. The therapeutic effect is documented using the Clinical Global Impression Scale subscale for Global Improvement. Adverse drug reactions (ADRs) are assessed using the Udvalg for Kliniske Undersogelser-Side Effect Rating Scale. One hundred fifteen patients (mean age = 15.9 years; range = 10.4-18.8 years; 40.9% male) were included. The majority (72.1%) was cotreated with other psychotropic drugs. A positive medium linear relationship (r = 0.619; P < 0.001) between olanzapine dose (mean = 11.64 mg/d) and serum concentration (mean = 35.65 ng/mL) was found with a marked interindividual variability of serum concentrations. Neither relationship between olanzapine serum concentration and treatment response (clinical benefit documented in 80%) nor ADRs (documented in 53.3%, in 7.5% judged as severe) was detected. Most of the patients with psychotic and eating disorders (68.8% and 71.8%, respectively) had an olanzapine serum concentration within the TR suggested for adults. There are several limitations of this study because of the naturalistic design, and our results should therefore be interpreted with caution. As most of the patients showed a clinical benefit under olanzapine concentrations within the TR for adults and only a minority had severe ADRs, it is reasonable to conclude a similar TR for children, adolescents, and adults.

A method for monitoring the variability in nuclear absorption characteristics of aviation fuels

NASA Technical Reports Server (NTRS)

Sprinkle, Danny R.; Shen, Chih-Ping

1988-01-01

A technique for monitoring variability in the nuclear absorption characteristics of aviation fuels has been developed. It is based on a highly collimated low energy gamma radiation source and a sodium iodide counter. The source and the counter assembly are separated by a geometrically well-defined test fuel cell. A computer program for determining the mass attenuation coefficient of the test fuel sample, based on the data acquired for a preset counting period, has been developed and tested on several types of aviation fuel.

Is it me? Verbal self-monitoring neural network and clinical insight in schizophrenia.

PubMed

Sapara, Adegboyega; Ffytche, Dominic H; Cooke, Michael A; Williams, Steven C R; Kumari, Veena

2015-12-30

Self-monitoring, defined as the ability to distinguish between self-generated stimuli from other-generated ones, is known to be impaired in schizophrenia. This impairment has been theorised as the basis for many of the core psychotic symptoms, in particular, poor clinical insight. This study aimed to investigate verbal self-monitoring related neural substrates of preserved and poor clinical insight in schizophrenia. It involved 40 stable schizophrenia outpatients, 20 with preserved and 20 with poor insight, and 20 healthy participants. All participants underwent functional magnetic resonance imaging with brain coverage covering key areas in the self-monitoring network during a verbal self-monitoring task. Healthy participants showed higher performance accuracy and greater thalamic activity than both preserved and poor insight patient groups. Preserved insight patients showed higher activity in the putamen extending into the caudate, insula and inferior frontal gyrus, compared to poor insight patients, and in the anterior cingulate and medial frontal gyrus, compared to healthy participants. Poor insight patients did not show greater activity in any brain area compared to preserved insight patients or healthy participants. Future studies may pursue therapeutic avenues, such as meta-cognitive therapies to promote self-monitoring or targeted stimulation of relevant brain areas, as means of enhancing insight in schizophrenia. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Assessment of published models and prognostic variables in epithelial ovarian cancer at Mayo Clinic

PubMed Central

Hendrickson, Andrea Wahner; Hawthorne, Kieran M.; Goode, Ellen L.; Kalli, Kimberly R.; Goergen, Krista M.; Bakkum-Gamez, Jamie N.; Cliby, William A.; Keeney, Gary L.; Visscher, Dan W.; Tarabishy, Yaman; Oberg, Ann L.; Hartmann, Lynn C.; Maurer, Matthew J.

2015-01-01

Objectives Epithelial ovarian cancer (EOC) is an aggressive disease in which first line therapy consists of a surgical staging/debulking procedure and platinum based chemotherapy. There is significant interest in clinically applicable, easy to use prognostic tools to estimate risk of recurrence and overall survival. In this study we used a large prospectively collected cohort of women with EOC to validate currently published models and assess prognostic variables. Methods Women with invasive ovarian, peritoneal, or fallopian tube cancer diagnosed between 2000-2011 and prospectively enrolled into the Mayo Clinic Ovarian Cancer registry were identified. Demographics and known prognostic markers as well as epidemiologic exposure variables were abstracted from the medical record and collected via questionnaire. Six previously published models of overall and recurrence-free survival were assessed for external validity. In addition, predictors of outcome were assessed in our dataset. Results Previously published models validated with a range of c-statistics (0.587-0.827), though application of models containing variables not part of routine practice were somewhat limited by missing data; utilization of all applicable models and comparison of results is suggested. Examination of prognostic variables identified only the presence of ascites and ASA score to be independent predictors of prognosis in our dataset, albeit with marginal gain in prognostic information, after accounting for stage and debulking. Conclusions Existing prognostic models for newly diagnosed EOC showed acceptable calibration in our cohort for clinical application. However, modeling of prospective variables in our dataset reiterates that stage and debulking remain the most important predictors of prognosis in this setting. PMID:25620544

Clinical review: Neuromonitoring - an update

PubMed Central

2013-01-01

Critically ill patients are frequently at risk of neurological dysfunction as a result of primary neurological conditions or secondary insults. Determining which aspects of brain function are affected and how best to manage the neurological dysfunction can often be difficult and is complicated by the limited information that can be gained from clinical examination in such patients and the effects of therapies, notably sedation, on neurological function. Methods to measure and monitor brain function have evolved considerably in recent years and now play an important role in the evaluation and management of patients with brain injury. Importantly, no single technique is ideal for all patients and different variables will need to be monitored in different patients; in many patients, a combination of monitoring techniques will be needed. Although clinical studies support the physiologic feasibility and biologic plausibility of management based on information from various monitors, data supporting this concept from randomized trials are still required. PMID:23320763

Levetiracetam Clinical Pharmacokinetic Monitoring in Pediatric Patients with Epilepsy.

PubMed

Tan, Jason; Paquette, Vanessa; Levine, Marc; Ensom, Mary H H

2017-11-01

Levetiracetam is a broad-spectrum antiepileptic drug (AED) with a unique mechanism of action. Older AEDs can cause serious short- and long-term adverse drug reactions and complications, rendering them undesirable to use in pediatric patients. Characteristics that make levetiracetam a near-ideal AED include its broad spectrum of activity, good tolerability profile, and minimal drug-drug interactions. Clinical pharmacokinetic monitoring (CPM) is often recommended in pediatric patients for certain AEDs due to large interindividual pharmacokinetic differences and unpredictable drug disposition. Our objective was to determine whether monitoring levetiracetam concentrations is warranted for pediatric patients with epilepsy, using a previously published 9-step decision-making algorithm. A literature search of the MEDLINE (1946-August 2016), EMBASE (1974-August 2016), CENTRAL, and Google Scholar databases was performed to identify relevant English-language articles and answer the questions posed in the algorithm for levetiracetam CPM in pediatric epilepsies. Additional articles were identified from a manual bibliographic review of the relevant literature. We found that levetiracetam CPM met some criteria of the algorithm: levetiracetam is an appropriate adjunctive or monotherapy for pediatric patients with either focal or generalized seizures; it is readily measurable in plasma, with an appropriate degree of sensitivity, accuracy, and precision; it exhibits interindividual variation in pharmacokinetics; often, its pharmacologic effect cannot be easily measured; and the duration of therapy is expected to be long-term. However, important criteria not met include the following: there is no clear evidence for a concentration-response relationship for efficacy or toxicity; the proposed therapeutic range of 12-46 μg/mL is not well-defined and is generally considered as wide. Thus, clinical decision making is unlikely to be affected as a result of routine levetiracetam CPM. In

Clinical Validation of Non-Invasive Cardiac Output Monitoring in Healthy Pregnant Women.

PubMed

McLaughlin, Kelsey; Wright, Stephen P; Kingdom, John C P; Parker, John D

2017-11-01

Non-invasive hemodynamic monitoring has the potential to be a valuable clinical tool for the screening and management of hypertensive disorders of pregnancy. The objective of this study was to validate the clinical utility of the non-invasive cardiac output monitoring (NICOM) system in pregnant women. Twenty healthy pregnant women with a singleton pregnancy at 22 to 26 weeks' gestation were enrolled in this study. Measures of heart rate, stroke volume, and cardiac output were obtained through NICOM and compared with Doppler echocardiography. NICOM significantly overestimated measures of both stroke volume and cardiac output compared with Doppler echocardiography (95 ± 4 vs. 73 ± 4 mL, P < 0.0001; and 7.4 ± 0.2 vs. 5.6 ± 0.2 L/min, P < 0.0001; respectively). There is no gold standard for the measurement of cardiac output in the setting of pregnancy. However, once normal values have been established, NICOM has the potential to be a useful clinical tool for monitoring maternal hemodynamics in pregnant women. Further investigation regarding the validity of NICOM is required in larger populations of healthy and hypertensive pregnant women to determine whether this device is appropriate for maternal hemodynamic assessment during pregnancy. Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

Telemetric intra-cranial pressure monitoring: clinical and financial considerations.

PubMed

Barber, James M; Pringle, Catherine J; Raffalli-Ebezant, Helen; Pathmanaban, Omar; Ramirez, Roberto; Kamaly-Asl, Ian D

2017-06-01

Intracranial pressure (ICP) measurement is an important diagnostic tool in Neurosurgery. Until relatively recently, conventional monitoring has required that subjects be admitted to a hospital bed and the device is only able to be left in-situ for limited periods of time. We have evaluated a Telemetric ICP monitoring system that has been proven, by several other groups worldwide, to permit rapid, repeated and prolonged ICP measurement, in multiple environments. In our unit, 4 patients have been implanted to-date, between the ages of 4 and 16, manifesting a wide range of complex neurosurgical conditions. The sensors have been left in-situ for between 460 and 632 days. There have been no clinical complications and the system has been universally well tolerated. Clinical events, costs and patient experience were all assessed prior to and following implantation. Overall, there was a significant reduction in associated admissions (44.3%), imaging requirements (72.5%) and costs (50.0%). Subjective feedback from both the patients (where possible) and their families was overwhelmingly positive, partly due to (a) the system's ease of use, (b) its ability to reduce the number of admissions/tests required and (c) the facility for rapid measurement of ICP that permitted on-the-spot reassurance of concerns. Additionally, the ability to monitor ICP at home and/or whilst ambulant, has provided measurements that were hitherto inaccessible to our team, facilitating all the potential benefits that analysis of such information would provide. Indeed, we have seen the resultant management in each case has been completely altered by the availability of this data, reaffirming that the importance of being able to obtain it should not be underestimated. The combination of both this and the ability to markedly improve patient experience, along with generating significant cost-savings, lead the authors to suggest that the implantation of this system should be strongly considered in selected

Monitoring of airborne biological particles in outdoor atmosphere. Part 1: Importance, variability and ratios.

PubMed

Núñez, Andrés; Amo de Paz, Guillermo; Rastrojo, Alberto; García, Ana M; Alcamí, Antonio; Gutiérrez-Bustillo, A Montserrat; Moreno, Diego A

2016-03-01

The first part of this review ("Monitoring of airborne biological particles in outdoor atmosphere. Part 1: Importance, variability and ratios") describes the current knowledge on the major biological particles present in the air regarding their global distribution, concentrations, ratios and influence of meteorological factors in an attempt to provide a framework for monitoring their biodiversity and variability in such a singular environment as the atmosphere. Viruses, bacteria, fungi, pollen and fragments thereof are the most abundant microscopic biological particles in the air outdoors. Some of them can cause allergy and severe diseases in humans, other animals and plants, with the subsequent economic impact. Despite the harsh conditions, they can be found from land and sea surfaces to beyond the troposphere and have been proposed to play a role also in weather conditions and climate change by acting as nucleation particles and inducing water vapour condensation. In regards to their global distribution, marine environments act mostly as a source for bacteria while continents additionally provide fungal and pollen elements. Within terrestrial environments, their abundances and diversity seem to be influenced by the land-use type (rural, urban, coastal) and their particularities. Temporal variability has been observed for all these organisms, mostly triggered by global changes in temperature, relative humidity, et cetera. Local fluctuations in meteorological factors may also result in pronounced changes in the airbiota. Although biological particles can be transported several hundreds of meters from the original source, and even intercontinentally, the time and final distance travelled are strongly influenced by factors such as wind speed and direction. [Int Microbiol 2016; 19(1):1-1 3]. Copyright© by the Spanish Society for Microbiology and Institute for Catalan Studies.

Clinical variables related to antidepressant-induced mania in bipolar disorder.

PubMed

Mundo, Emanuela; Cattaneo, Elisabetta; Russo, Michela; Altamura, A Carlo

2006-06-01

The development of mania or hypomania during antidepressant treatment is a serious complication of the clinical management of bipolar disorder (BP). The primary aim of this study was to evaluate the clinical variables related to antidepressant-induced mania or hypomania (AIM) in patients with BP. DSM-IV BP-I or BP-II patients who had had at least one depressive episode treated with antidepressants were considered. Patients were subdivided into two groups according to the presence (n = 30) or absence (n = 106) of manic or hypomanic episodes occurring during antidepressant treatment. Possible predictive clinical variables of AIM were considered: gender, diagnostic subtype, age at onset, duration of illness, duration of untreated illness, type of antidepressant administered, number of previous spontaneous hypomanic or manic episodes, number of previous depressive episodes, presence of lifetime suicide attempts, presence of mood stabilizer treatments, presence of psychotic symptoms during spontaneous episodes, family history for psychiatric disorders in first degree relatives. Data were compared between the two groups, with (AIM+) and without (AIM-) antidepressant-induced mania, using Student's t tests and chi-square tests. The lack of mood stabilizer treatments during antidepressant therapy (chi-square = 37.602, df = 1, p < 0.001) and the exposure to tricyclic antidepressants (chi-square = 4.901, df = 1, p < 0.05) resulted significantly associated to the development of AIM. This study was not done under controlled conditions and the relatively small sample studied warrants further replications. These results point out the risk of mania induction associated to the use of tricyclic antidepressants in BP patients, mainly in absence of adequate mood stabilizers.

Mass Spectrometry in Clinical Laboratory: Applications in Therapeutic Drug Monitoring and Toxicology.

PubMed

Garg, Uttam; Zhang, Yan Victoria

2016-01-01

Mass spectrometry (MS) has been used in research and specialized clinical laboratories for decades as a very powerful technology to identify and quantify compounds. In recent years, application of MS in routine clinical laboratories has increased significantly. This is mainly due to the ability of MS to provide very specific identification, high sensitivity, and simultaneous analysis of multiple analytes (>100). The coupling of tandem mass spectrometry with gas chromatography (GC) or liquid chromatography (LC) has enabled the rapid expansion of this technology. While applications of MS are used in many clinical areas, therapeutic drug monitoring, drugs of abuse, and clinical toxicology are still the primary focuses of the field. It is not uncommon to see mass spectrometry being used in routine clinical practices for those applications.

Outcome monitoring to facilitate clinical governance; experience from a national programme in the independent sector.

PubMed

Vallance-Owen, Andrew; Cubbin, Sally; Warren, Virginia; Matthews, Brian

2004-06-01

Since 1998 BUPA has used the Short-Form 36 (SF-36) questionnaire to monitor changes in health status after adult elective surgery. Over 70 independent hospitals across the United Kingdom have collected data on over 100000 patient episodes. SF-36 is one of a number of tools that support clinical governance in the sector. Results are reported confidentially, putting the emphasis on supporting a learning culture. FORMULATION OF PROBLEMS APPARENT AT 3 YEARS: Feedback was sub-optimal: discussions with hospital staff and consultants revealed that the league tables were hard to interpret, and there was uncertainty about the definition of outlier results. The number of patients recruited to the survey was variable across the hospitals. No grouping of low-volume procedures met with agreement. ACTION PLAN FOR YEAR 4: Use 'Shewhart' control charts to distinguish common and special cause variation in results; substitute a condition-specific tool in one instance; adoption of an 'alert' process to prompt local audit of unusual results; use of a reminder letter to improve return rate of follow-up questionnaires; and focus programme on a list of 20 common procedures. Discuss these changes with the managerial and clinical leaders of each of BUPA's hospitals. CURRENT POSITION AT YEAR 5 : The use of Shewhart charts has been welcomed by managers and clinicians at BUPA's hospitals. The renewed confidence in the programme has encouraged constructive debate into allowing wider access to previously confidential results. Some changes in clinical practice have occurred.

Studying the Variability of Bright Stars with the CONCAM Sky Monitoring Network

NASA Astrophysics Data System (ADS)

Pereira, W. E.; Nemiroff, R. J.; Rafert, J. B.; Perez-Ramirez, D.

2001-12-01

CONCAMs have now been deployed at some of the world's major observatories including KPNO in Arizona, Mauna Kea in Hawaii, and Wise Observatory in Israel. Data from these mobile, inexpensive and continuous sky cameras, consisting of a fish-eye lens mated to a CCD camera and run by a laptop, has been ever-increasing. Initial efforts to carry out photometric analysis of CONCAM fits images have now been fortified by a more automated technique of analyzing this data. Results of such analyses - variability of several bright stars, in particular, are presented, as well as the use of these cameras as cloud monitors to remote observers.

Emotional reaction evaluation provoked by the vestibular caloric test through physiological variables monitoring.

PubMed

Barona-de-Guzmán, Rafael; Krstulovic-Roa, Claudio; Donderis-Malea, Elena; Barona-Lleó, Luz

2018-03-08

The emotional evaluation of the causes of vertigo is made using the clinical records and several subjective questionnaires. The aim of the present study is to evaluate the emotional response objectively, in normal subjects, during an induced vertigo crisis. A caloric vestibular test with cold water was performed on 30 healthy subjects. The following physiological parameters were monitored during the 60seconds prior to and the 60seconds after the stimulation: Skin Conductivity, Peripheral Pulse Volume, Body Temperature, Muscle Contraction, Heart Rate, and Respiratory Rate. The maximum angular speed of the nystagmus slow phase at each stimulation was assessed. Skin conductance presented a statistically significant increase during the vertigo crisis in relation to the prior period while the peripheral pulse volume presented a statistically significant decrease. There was no relationship between the slow phase of the provoked nystagmus angular speed and skin conductance and peripheral pulse volume changes. The decrease in peripheral pulse volume was significantly higher in the second vertigo crisis. Skin conductance and peripheral pulse volume changed significantly during a vertigo crisis. There was no relation between the provoked vertiginous crisis intensity and the changes produced in those variables. The stress generated by the caloric stimulation is higher in the second crisis, when the subject has experience of the vertigo caused by the stimulation. Copyright © 2018 Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. Publicado por Elsevier España, S.L.U. All rights reserved.

Undergraduate Nurse Variables that Predict Academic Achievement and Clinical Competence in Nursing

ERIC Educational Resources Information Center

Blackman, Ian; Hall, Margaret; Darmawan, I Gusti Ngurah.

2007-01-01

A hypothetical model was formulated to explore factors that influenced academic and clinical achievement for undergraduate nursing students. Sixteen latent variables were considered including the students' background, gender, type of first language, age, their previous successes with their undergraduate nursing studies and status given for…

Incidence of postoperative hypothermia and the relationship to clinical variables.

PubMed

Burns, Shari M; Piotrowski, Kathy; Caraffa, Guy; Wojnakowski, Mary

2010-10-01

A prospective, quantitative, correlational study was conducted to determine the incidence of postoperative hypothermia and the relationship of hypothermia to numerous clinical variables previously studied. The study reflects the researchers' interest in updating previous data regarding the incidence of hypothermia. Although hypothermia remains a significant clinical concern, interventions aimed at minimizing hypothermia have evolved over the past 20 years, thus prompting new interest in determining the extent to which hypothermia exists in today's PACU patients. A convenience sample of 287 adult, nonemergency patients scheduled for surgery were included in the study. Hypothermia (temperature <36°C) was demonstrated in only 4% of the sample (N = 287). Because of the low incidence of hypothermia, correlation statistics were not performed. The study provides a foundation for future research regarding this important clinical phenomenon while offering evidence supporting efforts to avoid hypothermia in today's surgical patients. Copyright © 2010 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

On the Use of Local Assessments for Monitoring Centrally Reviewed Endpoints with Missing Data in Clinical Trials*

PubMed Central

Brummel, Sean S.; Gillen, Daniel L.

2014-01-01

Due to ethical and logistical concerns it is common for data monitoring committees to periodically monitor accruing clinical trial data to assess the safety, and possibly efficacy, of a new experimental treatment. When formalized, monitoring is typically implemented using group sequential methods. In some cases regulatory agencies have required that primary trial analyses should be based solely on the judgment of an independent review committee (IRC). The IRC assessments can produce difficulties for trial monitoring given the time lag typically associated with receiving assessments from the IRC. This results in a missing data problem wherein a surrogate measure of response may provide useful information for interim decisions and future monitoring strategies. In this paper, we present statistical tools that are helpful for monitoring a group sequential clinical trial with missing IRC data. We illustrate the proposed methodology in the case of binary endpoints under various missingness mechanisms including missing completely at random assessments and when missingness depends on the IRC’s measurement. PMID:25540717

The role of external evidence in data monitoring of a clinical trial.

PubMed

Pocock, S J

1996-06-30

Data monitoring of interim results from a randomized clinical trial should take into consideration evidence from other trials. This article presents both scientific and practical issues regarding the pros and cons of formally incorporating such external evidence into the decision making process for the current trial. Guidelines on how to use other trials' data are presented, along with cautiously sceptical comments on the impracticality of using formal meta-analyses in data monitoring. The arguments are illustrated by recent examples from specific trials, and the article concludes with some general recommendations.

Phosphoglucomutase-1 deficiency: Intrafamilial clinical variability and common secondary adrenal insufficiency.

PubMed

Loewenthal, Neta; Haim, Alon; Parvari, Ruti; Hershkovitz, Eli

2015-12-01

Phosphoglucomutase 1 (PGM1, EC 5.4.2.2) plays a critical role in glucose homeostasis and is also essential for protein N-glycosylation. The main clinical manifestations of PGM1 deficiency (MIM 614921) reported in 19 patients from different ethnic backgrounds include the following: cleft uvula/palate, Pierre Robin sequence, muscle weakness, dilated cardiomyopathy, growth retardation, elevated serum transaminases, hypoglycemia, and various endocrine abnormalities. We report the variable clinical picture of seven patients with PGM1 deficiency from a consanguineous family. Medical records of the patients were reviewed for clinical details and endocrine evaluation. Whole exome sequencing (WES) was performed. Seven patients aged 2-29 years were included, one patient died at 13 years old when getting off the school bus. All patients have an abnormal palatine structure (cleft palate, bifid uvula) and elevated serum transaminases, 4/7 have short stature (<-2 SDS) and one was diagnosed with growth hormone deficiency. Recurrent episodes of ketotic hypoglycemia were present in 6/7 patients. In two patients, hypoglycemic episodes have spontaneously resolved later on. Four out of seven patients have deteriorating adrenal function with abnormally low cortisol and ACTH levels during hypoglycemia and subnormal response of cortisol to low dose ACTH test . Serum electrolytes were within normal range. Hydrocortisone replacement therapy improved, but not entirely eliminated hypoglycemic episodes. WES revealed a previously described homozygous mutation c.112A>T, p.Asn38Tyr in the PGM1 gene. The clinical picture of PGM1 deficiency is variable among patients with the same mutation and genetic background. ACTH deficiency should be considered in any PGM1 deficient patient with hypoglycemia. © 2015 Wiley Periodicals, Inc.

Changes in heart rate variability during TOVA testing in patients with major depressive disorder.

PubMed

Shen, Tsu-Wang; Liu, Fang-Chih; Chen, Shaw-Ji; Chen, Shao-Tsu

2013-01-01

The aim of this study was to identify major depressive disorder (MDD) based on heart rate variability (HRV) during tests of variables of attention (TOVA). Forty-five MDD patients without cardiovascular disease and 45 controls matched by age and gender participated in this study. Compared to the controls, the MDD group had lower resting HRV parameters, more omissions and variability and longer response times on TOVA, and failure of attention employment to decrease HRV. The resting HRV parameters may provide easily measured, clinically useful ways to identify patients with MDD and to monitor their progress in treatment. © 2013 The Authors. Psychiatry and Clinical Neurosciences © 2013 Japanese Society of Psychiatry and Neurology.

Continuous Glucose Monitoring and Trend Accuracy

PubMed Central

Gottlieb, Rebecca; Le Compte, Aaron; Chase, J. Geoffrey

2014-01-01

Continuous glucose monitoring (CGM) devices are being increasingly used to monitor glycemia in people with diabetes. One advantage with CGM is the ability to monitor the trend of sensor glucose (SG) over time. However, there are few metrics available for assessing the trend accuracy of CGM devices. The aim of this study was to develop an easy to interpret tool for assessing trend accuracy of CGM data. SG data from CGM were compared to hourly blood glucose (BG) measurements and trend accuracy was quantified using the dot product. Trend accuracy results are displayed on the Trend Compass, which depicts trend accuracy as a function of BG. A trend performance table and Trend Index (TI) metric are also proposed. The Trend Compass was tested using simulated CGM data with varying levels of error and variability, as well as real clinical CGM data. The results show that the Trend Compass is an effective tool for differentiating good trend accuracy from poor trend accuracy, independent of glycemic variability. Furthermore, the real clinical data show that the Trend Compass assesses trend accuracy independent of point bias error. Finally, the importance of assessing trend accuracy as a function of BG level is highlighted in a case example of low and falling BG data, with corresponding rising SG data. This study developed a simple to use tool for quantifying trend accuracy. The resulting trend accuracy is easily interpreted on the Trend Compass plot, and if required, performance table and TI metric. PMID:24876437

Design and Evaluation of an Intelligent Remote Tidal Volume Variability Monitoring System in E-Health Applications.

PubMed

Fekr, Atena Roshan; Radecka, Katarzyna; Zilic, Zeljko

2015-09-01

A reliable long-term monitoring and diagnosis of breath disorders at an early stage provides an improvement of medical act, life expectancy, and quality of life while decreasing the costs of treatment and medical services. Therefore, a real-time unobtrusive monitoring of respiration patterns, as well as breath parameters, is a critical need in medical applications. In this paper, we propose an intelligent system for patient home care, capable of measuring respiration rate and tidal volume variability via a wearable sensing technology. The proposed system is designed particularly for the goal of diagnosis and treatment in patients with pathological breathing, e.g., respiratory complications after surgery or sleep disorders. The complete system was comprised of wearable calibrated accelerometer sensor, Bluetooth low energy, and cloud database. The experiments are conducted with eight subjects and the overall error in respiration rate calculation is obtained 0.29%±0.33% considering SPR-BTA spirometer as the reference. We also introduce a method for tidal volume variability estimation while validated using Pearson correlation. Furthermore, since it is essential to detect the critical events resulted from sudden rise or fall in per breath tidal volume of the patients, we provide a technique to automatically find the accurate threshold values based on each individual breath characteristics. Therefore, the system is able to detect the major changes, precisely by more than 98%, and provide immediate feedback such as sound alarm for round-the-clock respiration monitoring.

Comparison of smartphone application-based vital sign monitors without external hardware versus those used in clinical practice: a prospective trial.

PubMed

Alexander, John C; Minhajuddin, Abu; Joshi, Girish P

2017-08-01

Use of healthcare-related smartphone applications is common. However, there is concern that inaccurate information from these applications may lead patients to make erroneous healthcare decisions. The objective of this study is to study smartphone applications purporting to measure vital sign data using only onboard technology compared with monitors used routinely in clinical practice. This is a prospective trial comparing correlation between a clinically utilized vital sign monitor (Propaq CS, WelchAllyn, Skaneateles Falls, NY, USA) and four smartphone application-based monitors Instant Blood Pressure, Instant Blood Pressure Pro, Pulse Oximeter, and Pulse Oximeter Pro. We performed measurements of heart rate (HR), systolic blood pressures (SBP), diastolic blood pressure (DBP), and oxygen saturation (SpO 2 ) using standard monitor and four smartphone applications. Analysis of variance was used to compare measurements from the applications to the routine monitor. The study was completed on 100 healthy volunteers. Comparison of routine monitor with the smartphone applications shows significant differences in terms of HR, SpO 2 and DBP. The SBP values from the applications were not significantly different from those from the routine monitor, but had wide limits of agreement signifying a large degree of variation in the compared values. The degree of correlation between monitors routinely used in clinical practice and the smartphone-based applications studied is insufficient to recommend clinical utilization. This lack of correlation suggests that the applications evaluated do not provide clinically meaningful data. The inaccurate data provided by these applications can potentially contribute to patient harm.

Clinical Audit of the Radiotherapy Process in Rectal Cancer: Clinical Practice Guidelines and Quality Certification Do Not Avert Variability in Clinical Practice.

PubMed

Torras, M G; Canals, E; Jurado-Bruggeman, D; Marín-Borras, S; Macià, M; Jové, J; Boladeras, A M; Muñoz-Montplet, C; Molero, J; Picón, C; Puigdemont, M; Aliste, L; Torrents, A; Guedea, F; Borras, J M

2018-06-01

The therapeutic approach to cancer is complex and multidisciplinary. Radiotherapy is among the essential treatments, whether used alone or in conjunction with other therapies. This study reports a clinical audit of the radiotherapy process to assess the process of care, evaluate adherence to agreed protocols and measure the variability to improve therapeutic quality for rectal cancer. Multicentre retrospective cohort study in a representative sample of patients diagnosed with rectal cancer in the Institut Català d'Oncologia, a comprehensive cancer centre with three different settings. We developed a set of indicators to assess the key areas of the radiotherapy process. The clinical audit consisted of a review of a random sample of 40 clinical histories for each centre. The demographic profile, histology and staging of patients were similar between centres. The MRI reports did not include the distance from tumour to mesorectal fascia (rCRM) in 38.3% of the cases. 96.7% of patients received the planned dose, and 57.4% received it at the planned time. Surgery followed neoadjuvant treatment in 96.7% of the patients. Among this group, postoperative CRM was recorded in 65.5% of the cases and was negative in 93.4% of these. With regard to the 34.5% (n = 40) of cases where no CRM value was stated, there were differences between the centres. Mean follow-up was 3.4 (SD 0.6) years, and overall survival at four years was 81.7%. The audit revealed a suboptimal degree of adherence to clinical practice guidelines. Significant variability between centres exists from a clinical perspective but especially with regard to organization and process. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

[Customizing dosage drugs what contribution in therapeutic drug monitoring?].

PubMed

Abdessadek, Mohammed; Magoul, Rabia; Amarti, Afaf; El Ouezzani, Seloua; Khabbal, Youssef

2014-01-01

Drug response is often variable from an individual to another: the same dose of drug administered to different patients could cause variable pharmacological effects in nature and intensity. Those effects are often the result of variability in drugs pharmacokinetics (absorption, distribution, metabolism and elimination) which alter their bioavailability. In fact, two factors should be taken into account: the disease(s) from which the patient suffers, and the associated drugs, because many drug interactions may alter their pharmacokinetics causing consequently quite enough of different therapeutic effects. The choice of the assay of the drug subject in monitoring is crucial, it allows quantifying the in vivo dose of the drug and the quality of compliance thereof, the pharmacokinetic characteristics allows the clinician to adjust the dosage by different approaches so that plasma concentrations are included in the therapeutic range. Therapeutic monitoring aims to increase clinical efficacy and to minimize toxicity.

Lack of irrefutable validation does not negate clinical utility of near-infrared spectroscopy monitoring: learning to trust new technology.

PubMed

Kane, Jason M; Steinhorn, David M

2009-09-01

Reliance on new monitoring device technology is based upon an understanding of how the device operates and its reliability in a specific clinical setting. The introduction of new monitoring devices will therefore elicit either distrust of the new technology and the data presented or adoption of new devices. The use of near-infrared spectroscopy (NIRS) technology to monitor vital organs in postoperative pediatric cardiac surgery patients has been extensively described yet controversy remains as to the use of this monitoring device. The following retrospective case series demonstrates how learning from trends in data elicited from 2-site NIRS monitoring provided important bedside insights. These insights led to changes in clinician behavior and reliance on NIRS monitoring for early recognition of clinically silent deteriorations. Disregard for the NIRS data may have led to a fatal outcome in an unstable patient who might have received more timely intervention if the NIRS data had been acknowledged earlier. This case series demonstrates that 2-site NIRS monitoring accurately reflects situations in which poor clinical outcomes may occur when declining trends in somatic tissue oxygen saturations are not corrected. Physician management of the postoperative pediatric cardiac surgery patient can change based upon the insights gained through the application of NIRS monitoring.

Clinical results from a noninvasive blood glucose monitor

NASA Astrophysics Data System (ADS)

Blank, Thomas B.; Ruchti, Timothy L.; Lorenz, Alex D.; Monfre, Stephen L.; Makarewicz, M. R.; Mattu, Mutua; Hazen, Kevin

2002-05-01

Non-invasive blood glucose monitoring has long been proposed as a means for advancing the management of diabetes through increased measurement and control. The use of a near-infrared, NIR, spectroscopy based methodology for noninvasive monitoring has been pursued by a number of groups. The accuracy of the NIR measurement technology is limited by challenges related to the instrumentation, the heterogeneity and time-variant nature of skin tissue, and the complexity of the calibration methodology. In this work, we discuss results from a clinical study that targeted the evaluation of individual calibrations for each subject based on a series of controlled calibration visits. While the customization of the calibrations to individuals was intended to reduce model complexity, the extensive requirements for each individual set of calibration data were difficult to achieve and required several days of measurement. Through the careful selection of a small subset of data from all samples collected on the 138 study participants in a previous study, we have developed a methodology for applying a single standard calibration to multiple persons. The standard calibrations have been applied to a plurality of individuals and shown to be persistent over periods greater than 24 weeks.

Clinical review: Continuous and simplified electroencephalography to monitor brain recovery after cardiac arrest

PubMed Central

2013-01-01

There has been a dramatic change in hospital care of cardiac arrest survivors in recent years, including the use of target temperature management (hypothermia). Clinical signs of recovery or deterioration, which previously could be observed, are now concealed by sedation, analgesia, and muscle paralysis. Seizures are common after cardiac arrest, but few centers can offer high-quality electroencephalography (EEG) monitoring around the clock. This is due primarily to its complexity and lack of resources but also to uncertainty regarding the clinical value of monitoring EEG and of treating post-ischemic electrographic seizures. Thanks to technical advances in recent years, EEG monitoring has become more available. Large amounts of EEG data can be linked within a hospital or between neighboring hospitals for expert opinion. Continuous EEG (cEEG) monitoring provides dynamic information and can be used to assess the evolution of EEG patterns and to detect seizures. cEEG can be made more simple by reducing the number of electrodes and by adding trend analysis to the original EEG curves. In our version of simplified cEEG, we combine a reduced montage, displaying two channels of the original EEG, with amplitude-integrated EEG trend curves (aEEG). This is a convenient method to monitor cerebral function in comatose patients after cardiac arrest but has yet to be validated against the gold standard, a multichannel cEEG. We recently proposed a simplified system for interpreting EEG rhythms after cardiac arrest, defining four major EEG patterns. In this topical review, we will discuss cEEG to monitor brain function after cardiac arrest in general and how a simplified cEEG, with a reduced number of electrodes and trend analysis, may facilitate and improve care. PMID:23876221

3D.07: CORRELATION BETWEEN THE ARTERIAL PRESSURE VARIABILITY ESTIMATED AT CLINICS, MAPA AND AMPA.

PubMed

Abellan-Huerta, J; García-Escribano, I A; Soto, R M; Leal, M; Torres, A; Guerrero, B; Melgar, A C; Soto, M; Soria, F; Abellan-Aleman, J

2015-06-01

To measure the variability (VB) of the arterial pressure (AP) with the use of serial measurements at the clinics (VBCLIN), with 24 h ambulatory monitoring (MAPA) (VBMAPA) and home automonitoring -AMPA- (VBAMPA) and to estimate a relationship among each method. This is an observational, descriptive and transversal study assessed with 91 hypertensive patients in treatment and stable with AP < 160/100 mmHg for the last 3 months. Patients between 50-80 years old were included. The VB of the AP was defined as the standard deviation for both, diastolic and systolic pressures. The different VB were determined with the use of tensiometers and validated AP monitors. VBCLIN was estimated from 8 measurements per week in the clinics. A 24 h MAPA was assessed to all the patients included in the study in order to obtain the VBMAPA and an AMPA in two non-consecutive weeks to obtain the VBAMPA (total of 54 measurements). 91 patients with 66 ± 7.7 years old and 58.2% males were recruited. AP values were 134 ± 14/82 ± 10 mmHg for systolic and diastolic APCLIN, respectively. AP values were 122 ± 17 / 68 ± 12 mmHg for systolic and diastolic APMAPA, respectively. AP values were 125 ± 13/75 ± 7 mmHg for systolic and diastolic APAMPA, respectively. The systolic VB for the three above methods was significantly correlated being maximal between VBCLIN and VBAMPA (r = 0.45; 0 < 0.001) and lower for VBCLIN and VBMAPA (r = 0.25; p = 0.015) and VBMAPA and VBAMPA (r = 0.32; p = 0.002). Means of the systolic AP between each method were statistically different except for VBCLIN and VBAMPA. Corresponding to diastolic AP VB, we could only found a significant relationship between VBCLIN and VBAMPA (r = 0.243; p = 0.021). The correlation between VB of AP measured in the clinics, with AMPA and MAPA methods is weak. This observation suggests that these are not interchangeable methodologies. Future studies focused on the

State-of-the-Art Sensor Technology in Spain: Invasive and Non-Invasive Techniques for Monitoring Respiratory Variables

PubMed Central

Domingo, Christian; Blanch, Lluis; Murias, Gaston; Luján, Manel

2010-01-01

The interest in measuring physiological parameters (especially arterial blood gases) has grown progressively in parallel to the development of new technologies. Physiological parameters were first measured invasively and at discrete time points; however, it was clearly desirable to measure them continuously and non-invasively. The development of intensive care units promoted the use of ventilators via oral intubation ventilators via oral intubation and mechanical respiratory variables were progressively studied. Later, the knowledge gained in the hospital was applied to out-of-hospital management. In the present paper we review the invasive and non-invasive techniques for monitoring respiratory variables. PMID:22399898

State-of-the-art sensor technology in Spain: invasive and non-invasive techniques for monitoring respiratory variables.

PubMed

Domingo, Christian; Blanch, Lluis; Murias, Gaston; Luján, Manel

2010-01-01

The interest in measuring physiological parameters (especially arterial blood gases) has grown progressively in parallel to the development of new technologies. Physiological parameters were first measured invasively and at discrete time points; however, it was clearly desirable to measure them continuously and non-invasively. The development of intensive care units promoted the use of ventilators via oral intubation ventilators via oral intubation and mechanical respiratory variables were progressively studied. Later, the knowledge gained in the hospital was applied to out-of-hospital management. In the present paper we review the invasive and non-invasive techniques for monitoring respiratory variables.

Blood pressure (BP) assessment-from BP level to BP variability.

PubMed

Feber, Janusz; Litwin, Mieczyslaw

2016-07-01

The assessment of blood pressure (BP) can be challenging in children, especially in very young individuals, due to their variable body size and lack of cooperation. In the absence of data relating BP with cardiovascular outcomes in children, there is a need to convert absolute BP values (in mmHg) into age-, gender- and height appropriate BP percentiles or Z-scores in order to compare a patient's BP with the BP of healthy children of the same age, but also of children of different ages. Traditionally, the interpretation of BP has been based mainly on the assessment of the BP level obtained by office, home or 24-h BP monitoring. Recent studies suggest that it is not only BP level (i.e. average BP) but also BP variability that is clinically important for the development of target organ damage, including the progression of chronic kidney disease. In this review we describe current methods to evaluate of BP level, outline available methods for BP variability assessment and discuss the clinical consequences of BP variability, including its potential role in the management of hypertension.

A retrospective clinical study of cervical restorations: longevity and failure-prognostic variables.

PubMed

Namgung, C; Rho, Y J; Jin, B H; Lim, B S; Cho, B H

2013-01-01

The aim of this retrospective clinical study was to compare the longevity of cervical restorations between resin composite (RC) and glass ionomer (GI) and to investigate variables predictive of their outcome. The clinical performance of the two restorative materials in function was compared using the ratings of the modified United States Public Health Service (USPHS) criteria. A total of 479 cervical restorations were included in the study. Ninety-one already-replaced restorations were reviewed from dental records. The other 388 restorations still in function were evaluated according to the modified USPHS criteria by two investigators. Longevity and prognostic variables were analyzed with the Kaplan-Meier survival analysis and multivariate Cox proportional hazard model. The clinical performances of the two materials were evaluated according to the ratings of the USPHS criteria and compared using the Pearson chi-square test and Fisher exact test. The longevity was not significantly different between RC and GI (median survival time, 10.4 ± 0.7 and 11.5 ± 1.1 years, respectively). The main reasons for failure were loss of retention (82.2%) and secondary caries (17.8%). The longevity of cervical restoration was significantly influenced by tooth group and operator group (Wald test, p<0.05), while material, gender, presence or absence of systemic diseases, arch, and reason for treatment did not affect the longevity. Contrary to the longevity, the clinical performance of RC was superior to GI in the criteria of retention, marginal discoloration, and marginal adaptation, but similar in secondary caries, wear, and postoperative sensitivity.

Establishing a Multicenter Longitudinal Clinical Cohort Study in Ethiopia: Advanced Clinical Monitoring of Antiretroviral Treatment Project.

PubMed

Teklu, Alula M; Tsegaye, Eyuel; Fekade, Daniel; Hailemelak, Abraham; Weiss, William; Hassen, Elham; Simmons, Nicole; Zewdu, Solomon; Berhan, Yifru; Getachew, Assefa; Hagos, Tesfalem; Alebachew, Achamyeleh; Damena, Melake; Sitotaw, Yohannes; Assefa, Yibeltal; Medhin, Girmay; Ruff, Andrea

2017-02-01

The purpose of this paper is to describe the establishment of the Advanced Clinical Monitoring of ART Project in Ethiopia for monitoring and evaluation of the longitudinal effectiveness of the ART program and to show the opportunities it presents. This cohort was established in response to the 2005 call by WHO for establishing additional mechanisms for stronger monitoring of ART and the need for creating the platform to generate evidence to guide the care given for the ever increasing number of patients on ART in Ethiopia. A participatory and multi-stage process which started from a consensus building workshop and steered by a mother protocol as well as guiding documents which dictated the degree of engagement and expectations was followed. The primary and secondary aims of the study were agreed upon. A multi-site longitudinal observational clinical cohort was established by a consortium of stakeholders including seven Ethiopian medical schools and their affiliated referral hospitals, John Hopkins University, Ethiopian Public Health Institute, Ministry of Science and Technology, US Centers for Disease Prevention and Control - CDC-Ethiopia, and the Federal Ministry of Health. Adult and adolescent cohorts covering the age range of 14+ years) and pediatric cohorts covering those below age 14 years were the two main cohorts. During the initial recruitment of these cohorts information was extracted from existing documents for a total of 2,100 adult participants. In parallel, a prospective cohort of 1,400 adult and adolescent patients were enrolled for ART initiation and follow-up. Using similar recruitment procedures, a total of 120 children were enrolled in each of retrospective and prospective cohorts. Replacement of participants were made in subsequent years based on lost follow up and death rates to maintain adequacy of the sample to be followed-up. Between January 2005 and August 2013 a total of 4,339 patients were followed for a median of 41.6 months and data on

The economic costs of routine INR monitoring in infants and children--examining point-of-care devices used within the home setting compared to traditional anticoagulation clinic monitoring.

PubMed

Gaw, James R; Crowley, Steven; Monagle, Paul; Jones, Sophie; Newall, Fiona

2013-07-01

The use of point-of-care (POC) devices within the home for routine INR monitoring has demonstrated reliability, safety and effectiveness in the management of infants and children requiring long-term warfarin therapy. However, a comprehensive cost-analysis of using this method of management, compared to attending anticoagulation clinics has not been reported. The aim of this study was to compare the estimated societal costs of attending anticoagulation clinics for routine INR monitoring to using a POC test in the home. This study used a comparative before-and-after design that included 60 infants and children managed via the Haematology department at a tertiary paediatric centre. Each participant was exposed to both modes of management at various times for a period of ≥3 months. A questionnaire, consisting of 25 questions was sent to families to complete and return. Data collected included: the frequency of monitoring, mode of travel to and from clinics, total time consumed, and primary carer's income level. The home monitoring cohort saved a total of 1 hour 19 minutes per INR test compared to attending anticoagulation clinics and had a cost saving to society of $66.83 (AUD) per INR test compared to traditional care; incorporating health sector costs, travel expenses and lost time. The traditional model of care requires a considerable investment of time per test from both child and carer. Home INR monitoring in infants and children provides greater societal economic benefits compared to traditional models. Copyright © 2013 Elsevier Ltd. All rights reserved.

Predictive variables for the occurrence of early clinical mastitis in primiparous Holstein cows under field conditions in France.

PubMed Central

Barnouin, J; Chassagne, M

2001-01-01

Holstein heifers from 47 dairy herds in France were enrolled in a field study to determine predictors for clinical mastitis within the first month of lactation. Precalving and calving variables (biochemical, hematological, hygienic, and disease indicators) were collected. Early clinical mastitis (ECM) predictive variables were analyzed by using a multiple logistic regression model (99 cows with ECM vs. 571 without clinical mastitis throughout the first lactation). Two variables were associated with a higher risk of ECM: a) difficult calving and b) medium and high white blood cell (WBC) counts in late gestation. Two prepartum indicators were associated with a lower ECM risk: a) medium and high serum concentrations of immunoglobulin G1 (IgG1) and b) high percentage of eosinophils among white blood cells. Calving difficulty and certain biological blood parameters (IgG1, eosinophils) could represent predictors that would merit further experimental studies, with the aim of designing programs for reducing the risk of clinical mastitis in the first lactation. PMID:11195522

Evaluating measurement models in clinical research: covariance structure analysis of latent variable models of self-conception.

PubMed

Hoyle, R H

1991-02-01

Indirect measures of psychological constructs are vital to clinical research. On occasion, however, the meaning of indirect measures of psychological constructs is obfuscated by statistical procedures that do not account for the complex relations between items and latent variables and among latent variables. Covariance structure analysis (CSA) is a statistical procedure for testing hypotheses about the relations among items that indirectly measure a psychological construct and relations among psychological constructs. This article introduces clinical researchers to the strengths and limitations of CSA as a statistical procedure for conceiving and testing structural hypotheses that are not tested adequately with other statistical procedures. The article is organized around two empirical examples that illustrate the use of CSA for evaluating measurement models with correlated error terms, higher-order factors, and measured and latent variables.

24-Hour Blood Pressure Variability Assessed by Average Real Variability: A Systematic Review and Meta-Analysis.

PubMed

Mena, Luis J; Felix, Vanessa G; Melgarejo, Jesus D; Maestre, Gladys E

2017-10-19

Although 24-hour blood pressure (BP) variability (BPV) is predictive of cardiovascular outcomes independent of absolute BP levels, it is not regularly assessed in clinical practice. One possible limitation to routine BPV assessment is the lack of standardized methods for accurately estimating 24-hour BPV. We conducted a systematic review to assess the predictive power of reported BPV indexes to address appropriate quantification of 24-hour BPV, including the average real variability (ARV) index. Studies chosen for review were those that presented data for 24-hour BPV in adults from meta-analysis, longitudinal or cross-sectional design, and examined BPV in terms of the following issues: (1) methods used to calculate and evaluate ARV; (2) assessment of 24-hour BPV determined using noninvasive ambulatory BP monitoring; (3) multivariate analysis adjusted for covariates, including some measure of BP; (4) association of 24-hour BPV with subclinical organ damage; and (5) the predictive value of 24-hour BPV on target organ damage and rate of cardiovascular events. Of the 19 assessed studies, 17 reported significant associations between high ARV and the presence and progression of subclinical organ damage, as well as the incidence of hard end points, such as cardiovascular events. In all these cases, ARV remained a significant independent predictor ( P <0.05) after adjustment for BP and other clinical factors. In addition, increased ARV in systolic BP was associated with risk of all cardiovascular events (hazard ratio, 1.18; 95% confidence interval, 1.09-1.27). Only 2 cross-sectional studies did not find that high ARV was a significant risk factor. Current evidence suggests that ARV index adds significant prognostic information to 24-hour ambulatory BP monitoring and is a useful approach for studying the clinical value of BPV. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Learning neuroendoscopy with an exoscope system (video telescopic operating monitor): Early clinical results.

PubMed

Parihar, Vijay; Yadav, Y R; Kher, Yatin; Ratre, Shailendra; Sethi, Ashish; Sharma, Dhananjaya

2016-01-01

Steep learning curve is found initially in pure endoscopic procedures. Video telescopic operating monitor (VITOM) is an advance in rigid-lens telescope systems provides an alternative method for learning basics of neuroendoscopy with the help of the familiar principle of microneurosurgery. The aim was to evaluate the clinical utility of VITOM as a learning tool for neuroendoscopy. Video telescopic operating monitor was used 39 cranial and spinal procedures and its utility as a tool for minimally invasive neurosurgery and neuroendoscopy for initial learning curve was studied. Video telescopic operating monitor was used in 25 cranial and 14 spinal procedures. Image quality is comparable to endoscope and microscope. Surgeons comfort improved with VITOM. Frequent repositioning of scope holder and lack of stereopsis is initial limiting factor was compensated for with repeated procedures. Video telescopic operating monitor is found useful to reduce initial learning curve of neuroendoscopy.

All-Sky Monitoring of Variable Sources with Fermi GBM

NASA Technical Reports Server (NTRS)

Wilson-Hodge, Colleen A.; Finger, Mark; Camero-Arranz, Ascension; Becklen, Elif; Jenke, Peter; Cpe. K/ K/; Steele, Iain; Case, Gary; Cherry, Mike; Rodi, James;

Noise Maps for Quantitative and Clinical Severity Towards Long-Term ECG Monitoring.

PubMed

Everss-Villalba, Estrella; Melgarejo-Meseguer, Francisco Manuel; Blanco-Velasco, Manuel; Gimeno-Blanes, Francisco Javier; Sala-Pla, Salvador; Rojo-Álvarez, José Luis; García-Alberola, Arcadi

2017-10-25

Noise and artifacts are inherent contaminating components and are particularly present in Holter electrocardiogram (ECG) monitoring. The presence of noise is even more significant in long-term monitoring (LTM) recordings, as these are collected for several days in patients following their daily activities; hence, strong artifact components can temporarily impair the clinical measurements from the LTM recordings. Traditionally, the noise presence has been dealt with as a problem of non-desirable component removal by means of several quantitative signal metrics such as the signal-to-noise ratio (SNR), but current systems do not provide any information about the true impact of noise on the ECG clinical evaluation. As a first step towards an alternative to classical approaches, this work assesses the ECG quality under the assumption that an ECG has good quality when it is clinically interpretable. Therefore, our hypotheses are that it is possible (a) to create a clinical severity score for the effect of the noise on the ECG, (b) to characterize its consistency in terms of its temporal and statistical distribution, and (c) to use it for signal quality evaluation in LTM scenarios. For this purpose, a database of external event recorder (EER) signals is assembled and labeled from a clinical point of view for its use as the gold standard of noise severity categorization. These devices are assumed to capture those signal segments more prone to be corrupted with noise during long-term periods. Then, the ECG noise is characterized through the comparison of these clinical severity criteria with conventional quantitative metrics taken from traditional noise-removal approaches, and noise maps are proposed as a novel representation tool to achieve this comparison. Our results showed that neither of the benchmarked quantitative noise measurement criteria represent an accurate enough estimation of the clinical severity of the noise. A case study of long-term ECG is reported

Regulating task-monitoring systems in response to variable reward contingencies and outcomes in cocaine addicts.

PubMed

Morie, Kristen P; De Sanctis, Pierfilippo; Garavan, Hugh; Foxe, John J

2016-03-01

We investigated anticipatory and consummatory reward processing in cocaine addiction. In addition, we set out to assess whether task-monitoring systems were appropriately recalibrated in light of variable reward schedules. We also examined neural measures of task-monitoring and reward processing as a function of hedonic tone, since anhedonia is a vulnerability marker for addiction that is obviously germane in the context of reward processing. High-density event-related potentials were recorded while participants performed a speeded response task that systematically varied anticipated probabilities of reward receipt. The paradigm dissociated feedback regarding task success (or failure) from feedback regarding the value of reward (or loss), so that task-monitoring and reward processing could be examined in partial isolation. Twenty-three active cocaine abusers and 23 age-matched healthy controls participated. Cocaine abusers showed amplified anticipatory responses to reward predictive cues, but crucially, these responses were not as strongly modulated by reward probability as in controls. Cocaine users also showed blunted responses to feedback about task success or failure and did not use this information to update predictions about reward. In turn, they showed clearly blunted responses to reward feedback. In controls and users, measures of anhedonia were associated with reward motivation. In cocaine users, anhedonia was also associated with diminished monitoring and reward feedback responses. Findings imply that reward anticipation and monitoring deficiencies in addiction are associated with increased responsiveness to reward cues but impaired ability to predict reward in light of task contingencies, compounded by deficits in responding to actual reward outcomes.

[Phenotypic variability in 47, XXX patients: Clinical report of four new cases].

PubMed

Goldschmidt, Ernesto; Márquez, Marisa; Solari, Andrea; Ziembar, María I; Laudicina, Alejandro

2010-08-01

The 47, XXX karyotype has a frequency of 1 in 1000 female newborns. However, this karyotype is not usually suspected at birth or childhood. These patients are usually diagnosed during adulthood when they develop premature ovarian failure or infertility, because the early phenotype doesn t have any specific features. The study describes four cases and the clinical variability of the 47, XXX karyotype.

Exploring variability of teaching & supervision at clinical clerkship teaching sites

PubMed Central

Naeem, Naghma; Elzubeir, Margaret; Al-Houqani, Mohammad; Ahmed, Luai Awad

2018-01-01

Objective: To explore undergraduate medical students’ perception of variation in teaching and supervision at different clinical teaching sites. Methods: This descriptive cross-sectional study was conducted at the College of Medicine & Health Sciences, United Arab Emirates University, UAE during 2017. Four clinical teaching sites affiliated with CMHS were evaluated namely Shaikh Khalifa Medical City (SKMC), Ambulatory Care Clinics (AC), Tawam Hospital (TH) and Al-Ain Hospital (AH). An online questionnaire was administered to year five and six students. Results: The response rate was 84.4%. Overall perception of the students about their clinical clerkship experience was positive. SKMC was rated as the best teaching site with mean rating of 3.79±0.97-4.79±0.43. The highest rated item was clinical teacher’s promotion of critical thinking in students while the lowest rated item was the opportunity to take responsibility for patient care. Ambulatory Care site had a mean rating of 2.33±1.23-4.13±1.19. The highest rated item at this site was the clinical teacher encouraging students to ask questions and participate actively. At Tawam Hospital, the mean ratings ranged between 2.65±1.64-4.31±0.86 with highest rated item being ability of the students to see cases with positive clinical findings. At the Al-Ain Hospital, the mean rating was in the range of 2.79±1.45-3.81±1.11. The item rated highest here was the ability of students to see cases with positive clinical findings. The lowest rated item at all three sites was the availability of on-call rooms and lockers. Significant variability was seen across training sites in the clinical teacher’s ability to act as professional role models, the opportunity for students to apply their previous knowledge to patient care and to independently assess patients before discussion with teachers. Conclusion: This study tool highlights variation in clinical teaching and supervision at four clinical teaching sites. It provides

Exploring variability of teaching & supervision at clinical clerkship teaching sites.

PubMed

Naeem, Naghma; Elzubeir, Margaret; Al-Houqani, Mohammad; Ahmed, Luai Awad

2018-01-01

To explore undergraduate medical students' perception of variation in teaching and supervision at different clinical teaching sites. This descriptive cross-sectional study was conducted at the College of Medicine & Health Sciences, United Arab Emirates University, UAE during 2017. Four clinical teaching sites affiliated with CMHS were evaluated namely Shaikh Khalifa Medical City (SKMC), Ambulatory Care Clinics (AC), Tawam Hospital (TH) and Al-Ain Hospital (AH). An online questionnaire was administered to year five and six students. The response rate was 84.4%. Overall perception of the students about their clinical clerkship experience was positive. SKMC was rated as the best teaching site with mean rating of 3.79±0.97-4.79±0.43. The highest rated item was clinical teacher's promotion of critical thinking in students while the lowest rated item was the opportunity to take responsibility for patient care. Ambulatory Care site had a mean rating of 2.33±1.23-4.13±1.19. The highest rated item at this site was the clinical teacher encouraging students to ask questions and participate actively. At Tawam Hospital, the mean ratings ranged between 2.65±1.64-4.31±0.86 with highest rated item being ability of the students to see cases with positive clinical findings. At the Al-Ain Hospital, the mean rating was in the range of 2.79±1.45-3.81±1.11. The item rated highest here was the ability of students to see cases with positive clinical findings. The lowest rated item at all three sites was the availability of on-call rooms and lockers. Significant variability was seen across training sites in the clinical teacher's ability to act as professional role models, the opportunity for students to apply their previous knowledge to patient care and to independently assess patients before discussion with teachers. This study tool highlights variation in clinical teaching and supervision at four clinical teaching sites. It provides specific, actionable information which can be

Nevada Monitoring System to Assess Climate Variability and Change

NASA Astrophysics Data System (ADS)

Devitt, D. A.; Arnone, J.; Biondi, F.; Fenstermaker, L. F.; Saito, L.; Young, M.; Riddle, B.; Strachan, S. D.; Bird, B.; McCurdy, G.; Lyles, B. F.

2010-12-01

The Nevada System of Higher Education (University of Nevada Las Vegas, University of Nevada Reno and the Desert Research Institute) was awarded a multiyear NSF EPSCoR grant to support infrastructure associated with regional climate change research. The overall project is comprised of 5 components: education, cyberinfrastructure, policy, climate modeling and water/ecology. The water and ecology components are using their infrastructure funding for the assessment of climate variability and change on ecosystem function and hydrologic services. A series of 10 m tall towers are under construction and are being equipped with a wide array of sensors to monitor atmospheric, soil and plant parameters over time. The towers are located within the Mojave and Great Basin Deserts in two transects; the Mojave Desert transect is located in the southern Nevada Sheep Mountain Range and the Great Basin transect is located in the east central Nevada Snake Mountain Range. The towers are centrally positioned in well-defined vegetation zones. In southern Nevada these zones are represented by the following plant species: Creosote/Bursage (Creosotebush scrub zone); Blackbrush/Joshua Tree (Blackbrush zone); Pinyon/ Juniper (pygmy conifer zone), Ponderosa Pine (montane zone) and Bristlecone Pine (subalpine zone). The Snake Mountain transect incorporates the eastern and western valleys on both sides of the mountain range. The vegetation zones are represented by: Greasewood and mixed shrub (salt desert zone); Big Sage (sagebrush zone); Pinyon/Juniper (pygmy conifer zone); White/Douglas Fir, Ponderosa Pine and Aspen (montane zone); and Bristlecone/Limber Pine and Engelmann Spruce (subalpine zone). We are currently in the third year of funding with a goal of having the majority of towers fully operational by winter 2010. In close collaboration with our cyberinfrastructure component team, all data acquired from the transect monitoring stations will be made available to other researchers and the

Predictive value of clinical and laboratory variables for vesicoureteral reflux in children.

PubMed

Soylu, Alper; Kasap, Belde; Demir, Korcan; Türkmen, Mehmet; Kavukçu, Salih

2007-06-01

We aimed to determine the predictability of clinical and laboratory variables for vesicoureteral reflux (VUR) in children with urinary tract infection (UTI). Data of children with febrile UTI who underwent voiding cystoureterography between 2002 and 2005 were evaluated retrospectively for clinical (age, gender, fever > or = 38.5 degrees C, recurrent UTI), laboratory [leukocytosis, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), pyuria, serum creatinine (S(Cr))] and imaging (renal ultrasonography) variables. Children with VUR (group 1) vs. no VUR (group 2) and children with high-grade (III-V) VUR (group 3) vs. no or low-grade (I-II) VUR (group 4) were compared. Among 88 patients (24 male), 38 had VUR and 21 high-grade VUR. Fever > or = 38.5 degrees C was associated with VUR [odds ratio (OR): 7.5]. CRP level of 50 mg/l was the best cut-off level for predicting high-grade VUR (OR 15.5; discriminative ability 0.89 +/- 0.05). Performing voiding cystourethrography based on this CRP level would result in failure to notice 9% of patients with high-grade VUR, whereas 69% of children with no/low-grade VUR would be spared from this invasive test. In conclusion, fever > or = 38 degrees C and CRP > 50 mg/l seem to be potentially useful clinical predictors of VUR and high-grade VUR, respectively, in pediatric patients with UTI. Further validation of these findings could limit unnecessary voiding cystourethrography.

In Vivo Imaging and Monitoring of Transplanted Stem Cells: Clinical Applications

PubMed Central

Rodriguez-Porcel, Martin

2010-01-01

Regenerative medicine using stem cells has appeared as a potential therapeutic alternative for coronary artery disease, and stem cell clinical studies are currently on their way. However, initial results of these studies have provided mixed information, in part because of the inability to correlate organ functional information with the presence/absence of transplanted stem cells. Recent advances in molecular biology and imaging have allowed the successful noninvasive monitoring of transplanted stem cells in the living subject. In this article, different imaging strategies (direct labeling, indirect labeling with reporter genes) to study the viability and biology of stem cells are discussed. In addition, the limitations of each approach and imaging modality (eg, single photon emission computed tomography, positron emission tomography, and MRI) and their requirements for clinical use are addressed. Use of these strategies will be critical as the different regenerative therapies are being tested for clinical use. PMID:20425184

Patient Smartphone Ownership and Interest in Mobile Apps to Monitor Symptoms of Mental Health Conditions: A Survey in Four Geographically Distinct Psychiatric Clinics.

PubMed

Torous, John; Chan, Steven Richard; Yee-Marie Tan, Shih; Behrens, Jacob; Mathew, Ian; Conrad, Erich J; Hinton, Ladson; Yellowlees, Peter; Keshavan, Matcheri

2014-01-01

Despite growing interest in mobile mental health and utilization of smartphone technology to monitor psychiatric symptoms, there remains a lack of knowledge both regarding patient ownership of smartphones and their interest in using such to monitor their mental health. To provide data on psychiatric outpatients' prevalence of smartphone ownership and interest in using their smartphones to run applications to monitor their mental health. We surveyed 320 psychiatric outpatients from four clinics around the United States in order to capture a geographically and socioeconomically diverse patient population. These comprised a state clinic in Massachusetts (n=108), a county clinic in California (n=56), a hybrid public and private clinic in Louisiana (n=50), and a private/university clinic in Wisconsin (n=106). Smartphone ownership and interest in utilizing such to monitor mental health varied by both clinic type and age with overall ownership of 62.5% (200/320), which is slightly higher than the average United States' rate of ownership of 58% in January 2014. Overall patient interest in utilizing smartphones to monitor symptoms was 70.6% (226/320). These results suggest that psychiatric outpatients are interested in using their smartphones to monitor their mental health and own the smartphones capable of running mental healthcare related mobile applications.

Patient Smartphone Ownership and Interest in Mobile Apps to Monitor Symptoms of Mental Health Conditions: A Survey in Four Geographically Distinct Psychiatric Clinics

PubMed Central

Chan, Steven Richard; Yee-Marie Tan, Shih; Behrens, Jacob; Mathew, Ian; Conrad, Erich J; Hinton, Ladson; Yellowlees, Peter; Keshavan, Matcheri

2014-01-01

Background Despite growing interest in mobile mental health and utilization of smartphone technology to monitor psychiatric symptoms, there remains a lack of knowledge both regarding patient ownership of smartphones and their interest in using such to monitor their mental health. Objective To provide data on psychiatric outpatients’ prevalence of smartphone ownership and interest in using their smartphones to run applications to monitor their mental health. Methods We surveyed 320 psychiatric outpatients from four clinics around the United States in order to capture a geographically and socioeconomically diverse patient population. These comprised a state clinic in Massachusetts (n=108), a county clinic in California (n=56), a hybrid public and private clinic in Louisiana (n=50), and a private/university clinic in Wisconsin (n=106). Results Smartphone ownership and interest in utilizing such to monitor mental health varied by both clinic type and age with overall ownership of 62.5% (200/320), which is slightly higher than the average United States’ rate of ownership of 58% in January 2014. Overall patient interest in utilizing smartphones to monitor symptoms was 70.6% (226/320). Conclusions These results suggest that psychiatric outpatients are interested in using their smartphones to monitor their mental health and own the smartphones capable of running mental healthcare related mobile applications. PMID:26543905

[Clinical importance of semi-quantitative monitoring of lymphomas using the comparative polymerase chain reaction].

PubMed

Slavícková, A; Ivánek, R; Cerný, J; Sálková, J; Trnĕný, M

2002-11-22

PCR techniques detecting interchromosomal translocation and clonal immunoglobulin gene rearrangement (IgH) as disease markers in non-Hodgkin's lymphomas (NHL) has been utilised past ten years. However, qualitative PCR detection of persisted minimal residual disease cannot provide clinically useful prognostic information and presently, quantitative approaches are required to predict patient outcome and assess response to the treatment. In some cases, "end-point" quantifying techniques, such as comparative PCR, are applicable and the relative estimation of differences in target quantity may serve in disease monitoring rather than absolute number of target copies. Our method of comparative PCR employs co-amplification of sequences of interest (clonal CDR3, bcl2/Jh) and the segment of Hras 1 gene(ras) as an internal standard. Serial dilutions of stored diagnostic DNAs from blood and bone marrow are examined in the same PCR and, after gel densitometry, the amount of initial target is assessed by comparing exponential products of co-amplification. The comparative PCR assay was utilized in monitoring of NHL patients cured either with conventional therapy, or with high-dose regimens and transplantation with stem cells, or with chimaeric anti-CD20 monoclonal antibody (Rituximab). Results from 50 monitored intervals obtained during several months up to several years were supplemented with clinical statements retrospectively. Some of patients became PCR-negative, reappearance of PCR-positivity was observed as well. The decrease or increase of disease marker corresponded to clinical observations. Results obtained from bone marrow were in agreement with those obtained from blood. End-point quantifying PCR comparative assay may provide an information on the increased risk of relapse and impact of the therapy. The predictive value of these methods depends on the frequency of sample taking and on the sensitivity of the method, which should be monitored in negative cases.

Three-month validation of a turbuhaler electronic monitoring device: implications for asthma clinical trial use.

PubMed

Pilcher, Janine; Shirtcliffe, Philippa; Patel, Mitesh; McKinstry, Steve; Cripps, Terrianne; Weatherall, Mark; Beasley, Richard

2015-01-01

Electronic monitoring of inhaled asthma therapy is suggested as the 'gold standard' for measuring patterns of medication use in clinical trials. The SmartTurbo (Adherium (NZ) Ltd, Auckland, New Zealand) is an electronic monitor for use with a turbuhaler device (AstraZeneca, UK). The aim of this study was to determine the accuracy of the SmartTurbo in recording Symbicort actuations over a 12-week period of use. Twenty SmartTurbo monitors were attached to the base of 20 Symbicort turbuhalers. Bench testing in a research facility was undertaken on days 0, 5, 6, 7, 8, 9, 14, 21, 28, 56 and 84. Patterns of 'low-use' (2 sets of 2 actuations on the same day) and 'high-use' (2 sets of 8 actuations on the same day) were performed. The date and time of actuations were recorded in a paper diary and compared with data uploaded from the SmartTurbo monitors. 2800 actuations were performed. Monitor sensitivity was 99.9% with a lower 97.5% confidence bound of 99.6%. The positive predictive value was 99.9% with a 97.5% lower confidence bound of 99.7%. Accuracy was not affected by whether the pattern of inhaler use was low or high, or whether there was a delay in uploading the actuation data. The SmartTurbo monitor is highly accurate in recording and retaining electronic data in this 12-week bench study. It can be recommended for use in clinical trial settings, in which quality control systems are incorporated into study protocols to ensure accurate data acquisition.

Hybrid approaches to clinical trial monitoring: Practical alternatives to 100% source data verification.

PubMed

De, Sourabh

2011-07-01

For years, a vast majority of clinical trial industry has followed the tenet of 100% source data verification (SDV). This has been driven partly by the overcautious approach to linking quality of data to the extent of monitoring and SDV and partly by being on the safer side of regulations. The regulations however, do not state any upper or lower limits of SDV. What it expects from researchers and the sponsors is methodologies which ensure data quality. How the industry does it is open to innovation and application of statistical methods, targeted and remote monitoring, real time reporting, adaptive monitoring schedules, etc. In short, hybrid approaches to monitoring. Coupled with concepts of optimum monitoring and SDV at site and off-site monitoring techniques, it should be possible to save time required to conduct SDV leading to more available time for other productive activities. Organizations stand to gain directly or indirectly from such savings, whether by diverting the funds back to the R&D pipeline; investing more in technology infrastructure to support large trials; or simply increasing sample size of trials. Whether it also affects the work-life balance of monitors who may then need to travel with a less hectic schedule for the same level of quality and productivity can be predicted only when there is more evidence from field.

Simultaneous monitoring of maternal and fetal heart rate variability during labor in relation with fetal gender.

PubMed

Gonçalves, Hernâni; Fernandes, Diana; Pinto, Paula; Ayres-de-Campos, Diogo; Bernardes, João

2017-11-01

Male gender is considered a risk factor for several adverse perinatal outcomes. Fetal gender effect on fetal heart rate (FHR) has been subject of several studies with contradictory results. The importance of maternal heart rate (MHR) monitoring during labor has also been investigated, but less is known about the effect of fetal gender on MHR. The aim of this study is to simultaneously assess maternal and FHR variability during labor in relation with fetal gender. Simultaneous MHR and FHR recordings were obtained from 44 singleton term pregnancies during the last 2 hr of labor (H 1, H 2 ). Heart rate tracings were analyzed using linear (time- and frequency-domain) and nonlinear indices. Both linear and nonlinear components were considered in assessing FHR and MHR interaction, including cross-sample entropy (cross-SampEn). Mothers carrying male fetuses (n = 22) had significantly higher values for linear indices related with MHR average and variability and sympatho-vagal balance, while the opposite occurred in the high-frequency component and most nonlinear indices. Significant differences in FHR were only observed in H 1 with higher entropy values in female fetuses. Assessing the differences between FHR and MHR, statistically significant differences were obtained in most nonlinear indices between genders. A significantly higher cross-SampEn was observed in mothers carrying female fetuses (n = 22), denoting lower synchrony or similarity between MHR and FHR. The variability of MHR and the synchrony/similarity between MHR and FHR vary with respect to fetal gender during labor. These findings suggest that fetal gender needs to be taken into account when simultaneously monitoring MHR and FHR. © 2017 Wiley Periodicals, Inc.

The selected reaction monitoring/multiple reaction monitoring-based mass spectrometry approach for the accurate quantitation of proteins: clinical applications in the cardiovascular diseases.

PubMed

Gianazza, Erica; Tremoli, Elena; Banfi, Cristina

2014-12-01

Selected reaction monitoring, also known as multiple reaction monitoring, is a powerful targeted mass spectrometry approach for a confident quantitation of proteins/peptides in complex biological samples. In recent years, its optimization and application have become pivotal and of great interest in clinical research to derive useful outcomes for patient care. Thus, selected reaction monitoring/multiple reaction monitoring is now used as a highly sensitive and selective method for the evaluation of protein abundances and biomarker verification with potential applications in medical screening. This review describes technical aspects for the development of a robust multiplex assay and discussing its recent applications in cardiovascular proteomics: verification of promising disease candidates to select only the highest quality peptides/proteins for a preclinical validation, as well as quantitation of protein isoforms and post-translational modifications.

Renal function monitoring in heart failure - what is the optimal frequency? A narrative review.

PubMed

Al-Naher, Ahmed; Wright, David; Devonald, Mark Alexander John; Pirmohamed, Munir

2018-01-01

The second most common cause of hospitalization due to adverse drug reactions in the UK is renal dysfunction due to diuretics, particularly in patients with heart failure, where diuretic therapy is a mainstay of treatment regimens. Therefore, the optimal frequency for monitoring renal function in these patients is an important consideration for preventing renal failure and hospitalization. This review looks at the current evidence for optimal monitoring practices of renal function in patients with heart failure according to national and international guidelines on the management of heart failure (AHA/NICE/ESC/SIGN). Current guidance of renal function monitoring is in large part based on expert opinion, with a lack of clinical studies that have specifically evaluated the optimal frequency of renal function monitoring in patients with heart failure. Furthermore, there is variability between guidelines, and recommendations are typically nonspecific. Safer prescribing of diuretics in combination with other antiheart failure treatments requires better evidence for frequency of renal function monitoring. We suggest developing more personalized monitoring rather than from the current medication-based guidance. Such flexible clinical guidelines could be implemented using intelligent clinical decision support systems. Personalized renal function monitoring would be more effective in preventing renal decline, rather than reacting to it. © 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Incorporation of expert variability into breast cancer treatment recommendation in designing clinical protocol guided fuzzy rule system models.

PubMed

Garibaldi, Jonathan M; Zhou, Shang-Ming; Wang, Xiao-Ying; John, Robert I; Ellis, Ian O

2012-06-01

It has been often demonstrated that clinicians exhibit both inter-expert and intra-expert variability when making difficult decisions. In contrast, the vast majority of computerized models that aim to provide automated support for such decisions do not explicitly recognize or replicate this variability. Furthermore, the perfect consistency of computerized models is often presented as a de facto benefit. In this paper, we describe a novel approach to incorporate variability within a fuzzy inference system using non-stationary fuzzy sets in order to replicate human variability. We apply our approach to a decision problem concerning the recommendation of post-operative breast cancer treatment; specifically, whether or not to administer chemotherapy based on assessment of five clinical variables: NPI (the Nottingham Prognostic Index), estrogen receptor status, vascular invasion, age and lymph node status. In doing so, we explore whether such explicit modeling of variability provides any performance advantage over a more conventional fuzzy approach, when tested on a set of 1310 unselected cases collected over a fourteen year period at the Nottingham University Hospitals NHS Trust, UK. The experimental results show that the standard fuzzy inference system (that does not model variability) achieves overall agreement to clinical practice around 84.6% (95% CI: 84.1-84.9%), while the non-stationary fuzzy model can significantly increase performance to around 88.1% (95% CI: 88.0-88.2%), p<0.001. We conclude that non-stationary fuzzy models provide a valuable new approach that may be applied to clinical decision support systems in any application domain. Copyright © 2012 Elsevier Inc. All rights reserved.

Use of generalised additive models to categorise continuous variables in clinical prediction

PubMed Central

2013-01-01

Background In medical practice many, essentially continuous, clinical parameters tend to be categorised by physicians for ease of decision-making. Indeed, categorisation is a common practice both in medical research and in the development of clinical prediction rules, particularly where the ensuing models are to be applied in daily clinical practice to support clinicians in the decision-making process. Since the number of categories into which a continuous predictor must be categorised depends partly on the relationship between the predictor and the outcome, the need for more than two categories must be borne in mind. Methods We propose a categorisation methodology for clinical-prediction models, using Generalised Additive Models (GAMs) with P-spline smoothers to determine the relationship between the continuous predictor and the outcome. The proposed method consists of creating at least one average-risk category along with high- and low-risk categories based on the GAM smooth function. We applied this methodology to a prospective cohort of patients with exacerbated chronic obstructive pulmonary disease. The predictors selected were respiratory rate and partial pressure of carbon dioxide in the blood (PCO2), and the response variable was poor evolution. An additive logistic regression model was used to show the relationship between the covariates and the dichotomous response variable. The proposed categorisation was compared to the continuous predictor as the best option, using the AIC and AUC evaluation parameters. The sample was divided into a derivation (60%) and validation (40%) samples. The first was used to obtain the cut points while the second was used to validate the proposed methodology. Results The three-category proposal for the respiratory rate was ≤ 20;(20,24];> 24, for which the following values were obtained: AIC=314.5 and AUC=0.638. The respective values for the continuous predictor were AIC=317.1 and AUC=0.634, with no statistically

Ambulatory blood pressure monitoring-derived short-term blood pressure variability is increased in Cushing's syndrome.

PubMed

Rebellato, Andrea; Grillo, Andrea; Dassie, Francesca; Sonino, Nicoletta; Maffei, Pietro; Martini, Chiara; Paoletta, Agostino; Fabris, Bruno; Carretta, Renzo; Fallo, Francesco

2014-11-01

Cushing's syndrome is associated with high cardiovascular morbility and mortality. Blood pressure (BP) variability within a 24-h period is increasingly recognized as an independent predictor of cardiovascular risk. The aim of our study was to investigate the short-term BP variability indices in Cushing's syndrome. Twenty-five patients with Cushing's syndrome (mean age 49 ± 13 years, 4 males; 21 Cushing's disease and 4 adrenal adenoma patients) underwent 24-h ambulatory BP monitoring (ABPM) and evaluation of cardiovascular risk factors. Cushing patients were divided into 8 normotensive (NOR-CUSH) and 17 hypertensive (HYP-CUSH) patients and were compared with 20 normotensive (NOR-CTR) and 20 hypertensive (HYP-CTR) age-, sex-, and BMI-matched control subjects. Short-term BP variability was derived from ABPM and calculated as the following: (1) standard deviation (SD) of 24-h, daytime, and nighttime BP; (2) 24-h weighted SD of BP; and (3) average real variability (ARV), i.e., the average of the absolute differences between consecutive BP measurements over 24 h. In comparison with controls, patients with Cushing's syndrome, either normotensive or hypertensive, had higher 24-h and daytime SD of BP, as well as higher 24-h weighted SD and ARV of BP (P = 0.03 to P < 0.0001). No difference in metabolic parameters was observed between NOR-CTR and NOR-CUSH or between HYP-CTR and HYP-CUSH subgroups. ABPM-derived short-term BP variability is increased in Cushing's syndrome, independent of BP elevation. It may represent an additional cardiovascular risk factor in this disease. The role of excess cortisol in BP variability has to be further clarified.

Association between different measurements of blood pressure variability by ABP monitoring and ankle-brachial index.

PubMed

Wittke, Estefânia; Fuchs, Sandra C; Fuchs, Flávio D; Moreira, Leila B; Ferlin, Elton; Cichelero, Fábio T; Moreira, Carolina M; Neyeloff, Jeruza; Moreira, Marina B; Gus, Miguel

2010-11-05

Blood pressure (BP) variability has been associated with cardiovascular outcomes, but there is no consensus about the more effective method to measure it by ambulatory blood pressure monitoring (ABPM). We evaluated the association between three different methods to estimate BP variability by ABPM and the ankle brachial index (ABI). In a cross-sectional study of patients with hypertension, BP variability was estimated by the time rate index (the first derivative of SBP over time), standard deviation (SD) of 24-hour SBP; and coefficient of variability of 24-hour SBP. ABI was measured with a doppler probe. The sample included 425 patients with a mean age of 57 ± 12 years, being 69.2% women, 26.1% current smokers and 22.1% diabetics. Abnormal ABI (≤ 0.90 or ≥ 1.40) was present in 58 patients. The time rate index was 0.516 ± 0.146 mmHg/min in patients with abnormal ABI versus 0.476 ± 0.124 mmHg/min in patients with normal ABI (P = 0.007). In a logistic regression model the time rate index was associated with ABI, regardless of age (OR = 6.9, 95% CI = 1.1- 42.1; P = 0.04). In a multiple linear regression model, adjusting for age, SBP and diabetes, the time rate index was strongly associated with ABI (P < 0.01). None of the other indexes of BP variability were associated with ABI in univariate and multivariate analyses. Time rate index is a sensible method to measure BP variability by ABPM. Its performance for risk stratification of patients with hypertension should be explored in longitudinal studies.

Clinical evaluation of a new intracranial pressure monitoring device.

PubMed

Stendel, R; Heidenreich, J; Schilling, A; Akhavan-Sigari, R; Kurth, R; Picht, T; Pietilä, T; Suess, O; Kern, C; Meisel, J; Brock, M

2003-03-01

Continuous monitoring of intracranial pressure (ICP) still plays a key role in the management of patients at risk from intracranial hypertension. Numerous ICP-measuring devices are available. The aim of the present study was to investigate the clinical characteristics and the magnetic resonance imaging (MRI) compatibility of the recently developed Neurovent-P(REHAU AG+CO, REHAU, Germany) ICP monitoring device. In a prospective two-center study, a total of 98 patients with severe head injury, subarachnoid haemorrhage, intracerebral haemorrhage, and non-traumatic brain edema underwent intraparenchymal monitoring of ICP using the Neurovent-P. A control group comprising 50 patients underwent implantation of the Camino-OLM-110-4B ICP monitor. The zero drift of the probes was determined before and after the ICP recording period. Technical and medical complications were documented. The MRI compatibility of the Neurovent-P ICP probe was investigated by evaluating artifacts caused by the probe, probe function and temperature changes during MRI, and probe movement caused by the magnetic field. The mean zero drift was 0.2+/-0.41 mmHg (maximum 3 mmHg) for the Neurovent-P ICP probes and 0.4+/-0.57 mmHg (maximum 12 mmHg) for the Camino-OLM-110-4B ICP probes. No significant correlation was identified between the extent of zero drift following the removal of the probes and the length of monitoring. Intraparenchymal haemorrhage spatially related to the probe occurred in 1 out of 50 (2%) patients with a Camino-OLM-110-4B probe and in 1 out of 98 (1%) with a Neurovent-P. Damage of the probe due to kinking or overextension of the cable or glass fiber occurred in 4 of the 50 (8%) Camino-OLM-110-4B ICP probes and in 5 of the 98 (5%) Neurovent-P probes. On T2-weighted MR images, the Neurovent-P ICP probe induced only small artifacts with very good discrimination of the surrounding tissue. On T1-weighted MR images, there was a good imaging quality but artifact-related local disturbances

Impact of clinical input variable uncertainties on ten-year atherosclerotic cardiovascular disease risk using new pooled cohort equations.

PubMed

Gupta, Himanshu; Schiros, Chun G; Sharifov, Oleg F; Jain, Apurva; Denney, Thomas S

2016-08-31

Recently released American College of Cardiology/American Heart Association (ACC/AHA) guideline recommends the Pooled Cohort equations for evaluating atherosclerotic cardiovascular risk of individuals. The impact of the clinical input variable uncertainties on the estimates of ten-year cardiovascular risk based on ACC/AHA guidelines is not known. Using a publicly available the National Health and Nutrition Examination Survey dataset (2005-2010), we computed maximum and minimum ten-year cardiovascular risks by assuming clinically relevant variations/uncertainties in input of age (0-1 year) and ±10 % variation in total-cholesterol, high density lipoprotein- cholesterol, and systolic blood pressure and by assuming uniform distribution of the variance of each variable. We analyzed the changes in risk category compared to the actual inputs at 5 % and 7.5 % risk limits as these limits define the thresholds for consideration of drug therapy in the new guidelines. The new-pooled cohort equations for risk estimation were implemented in a custom software package. Based on our input variances, changes in risk category were possible in up to 24 % of the population cohort at both 5 % and 7.5 % risk boundary limits. This trend was consistently noted across all subgroups except in African American males where most of the cohort had ≥7.5 % baseline risk regardless of the variation in the variables. The uncertainties in the input variables can alter the risk categorization. The impact of these variances on the ten-year risk needs to be incorporated into the patient/clinician discussion and clinical decision making. Incorporating good clinical practices for the measurement of critical clinical variables and robust standardization of laboratory parameters to more stringent reference standards is extremely important for successful implementation of the new guidelines. Furthermore, ability to customize the risk calculator inputs to better represent unique clinical

High sub-seasonal variability in water volume transports, revealed through a new ocean monitoring initiative using autonomous gliders

NASA Astrophysics Data System (ADS)

Heslop, E.; Ruiz, S.; Allen, J.; Tintoré, J.

2012-04-01

One of the clear challenges facing oceanography today is to define variability in ocean processes at a seasonal and sub-seasonal scale, in order to clearly identify the signature of both natural large-scale climatic oscillations and the long-term trends brought about by the human-induced change in atmospheric composition. Without visibility of this variance, which helps to determine the margins of significance for long-term trends and decipher cause and effect, the inferences drawn from sparse data points can be misleading. The cyclonic basin scale circulation pattern in the Western Mediterranean has long been known; the role/contribution that processes in the Balearic Basin play in modifying this is less well defined. The Balearic Channels (channels between the Balearic Islands) are constriction points on this basin scale circulation that appear to exert a controlling influence on the north/south exchange of water masses. Understanding the variability in current flows through these channels is important, not just for the transport of heat and salt, but also for ocean biology that responds to physical variability at the scale of that variability. Earlier studies at a seasonal scale identified; an interannual summer/winter variation of 1 Sv in the strength of the main circulation pattern and a high cruise-to-cruise variability in the pattern and strength of the flows through the channels brought about by mesoscale activity. Initial results using new high-resolution data from glider based monitoring missions across the Ibiza Channel (the main exchange channel in the Balearic Basin), combined with ship and contemporaneous satellite data, indicate surprisingly high and rapid changes in the flows of surface and intermediate waters imposed on the broad seasonal cycle. To date the data suggests that there are three potential 'modes' of water volume transport, generated from the interplay between basin and mesoscale circulation. We will review the concept of transport

The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.

PubMed

Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol

2013-05-01

Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum

Clinical outcomes and adverse effect monitoring in allergic rhinitis.

PubMed

Juniper, Elizabeth F; Ståhl, Elisabeth; Doty, Richard L; Simons, F Estelle R; Allen, David B; Howarth, Peter H

2005-03-01

The subjective recording in diary cards of symptoms of itch, sneeze, nose running, and blockage, with the use of a rating scale to indicate the level of severity, is usual for clinical trials in allergic rhinitis. The primary outcome measure is usually a composite score that enables a single total symptoms score endpoint. It is appreciated, however, that rhinitis has a greater effect on the individual than is reflected purely by the recording of anterior nasal symptoms. Nasal obstruction is troublesome and may lead to sleep disturbance in addition to impaired daytime concentration and daytime sleepiness. These impairments affect school and work performance. Individuals with rhinitis find it socially embarrassing to be seen sneezing, sniffing, or blowing their nose. To capture these and other aspects of the disease-specific health-related quality of life, questionnaires such as the Rhinoconjunctivitis Quality of Life Questionnaire have been developed and validated for clinical trial use. The adoption of health-related quality of life questionnaires into clinical trials broadens the information obtained regarding the effect of the therapeutic intervention and helps focus on issues relevant to the individual patient. It must be appreciated that it is not only the disease that may adversely affect health-related quality of life; administered therapy, although intended to be beneficial, may also cause health impairment. Adverse-event monitoring is thus essential in clinical trials. The first-generation H 1 -histamines, because of their effect on central H 1 -receptors, are classically associated with central nervous system (CNS) effects such as sedation. Although this is not always perceived by the patient, it is clearly evident with objective performance testing, and positron emission tomography scanning has directly demonstrated the central H 1 -receptor occupancy. The second-generation H 1 -antihistamines have reduced central H 1 -receptor occupancy and considerably

Assessing the seasonal variability of ephemeral gully erosion using high-frequency monitoring: case study in a fully cultivated catchment (The Pommeroye, Northern France)

NASA Astrophysics Data System (ADS)

Patault, E.; Alary, C.; Franke, C.; Gauthier, A.; Abriak, N. E.

2017-12-01

Gully erosion results in on-site and off-site problems including the loss of cultivated soils, the silting of riverbeds and dams as well as infrastructure and property damage by muddy floods. Regions of intensive agricultural production situated on the European loess belt are particularly affected. Recently a growing interest has focused on ephemeral gullies since there have been recognized as a major contributor to the sediment yield in small agricultural catchment in this area. The aims of this case study are (i) to quantify the sediment yield transported by ephemeral gullies, (ii) to identify parameters that control the function of the hydro-sedimentary response and (iii) to evaluate the influence of seasonal variability on the ephemeral gully erosion. For this study a high-frequency monitoring station was implemented. For each flood event, 8 variables related to hydro-sedimentary and rainfall dynamics are calculated and the relationships between these variables are analyzed using the Pearson correlation matrix and Principal Component Analysis. During the first year of monitoring (03/2016-03/2017), 22 flood events were recorded of which 75% occurred in spring and winter. The specific sediment yield was evaluated to 30 t km-2 yr-1 which is conventional for the study region but the results show a highly variable seasonal distribution; 90% of the sedimentary transfer occurred in winter and autumn. The main reasons were a high cumulative rainfall and a long duration for the events. The maximum suspended sediment concentration at the catchment outlet was observed in spring, likely due to maximum rainfall intensities in that season. Also, a huge variability between the events is observed; e.g. one exceptional rain storm in 11/2016 represents 45% of the total sediment yield of the study period. For the monitored 22 events, 2 different types of hysteresis behavior were observed: (i) clockwise and (ii) complex. In winter, only clockwise hysteresis was observed. These

Variability in adherence to clinical practice guidelines and recommendations in COPD outpatients: a multi-level, cross-sectional analysis of the EPOCONSUL study.

PubMed

Calle Rubio, Myriam; López-Campos, José Luis; Soler-Cataluña, Juan J; Alcázar Navarrete, Bernardino; Soriano, Joan B; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; Rodríguez Hermosa, Juan Luis

2017-12-02

Clinical audits have reported considerable variability in COPD medical care and frequent inconsistencies with recommendations. The objectives of this study were to identify factors associated with a better adherence to clinical practice guidelines and to explore determinants of this variability at the the hospital level. EPOCONSUL is a Spanish nationwide clinical audit that evaluates the outpatient management of COPD. Multilevel logistic regression with two levels was performed to assess the relationships between individual and disease-related factors, as well as hospital characteristics. A total of 4508 clinical records of COPD patients from 59 Spanish hospitals were evaluated. High variability was observed among hospitals in terms of medical care. Some of the patient's characteristics (airflow obstruction, degree of dyspnea, exacerbation risk, presence of comorbidities), the hospital factors (size and respiratory nurses available) and treatment at a specialized COPD outpatient clinic were identified as factors associated with a better adherence to recommendations, although this only explains a small proportion of the total variance. To be treated at a specialized COPD outpatient clinic and some intrinsic patient characteristics were factors associated with a better adherence to guideline recommendations, although these variables were only explaining part of the high variability observed among hospitals in terms of COPD medical care.

ChronQC: a quality control monitoring system for clinical next generation sequencing.

PubMed

Tawari, Nilesh R; Seow, Justine Jia Wen; Perumal, Dharuman; Ow, Jack L; Ang, Shimin; Devasia, Arun George; Ng, Pauline C

2018-05-15

ChronQC is a quality control (QC) tracking system for clinical implementation of next-generation sequencing (NGS). ChronQC generates time series plots for various QC metrics to allow comparison of current runs to historical runs. ChronQC has multiple features for tracking QC data including Westgard rules for clinical validity, laboratory-defined thresholds and historical observations within a specified time period. Users can record their notes and corrective actions directly onto the plots for long-term recordkeeping. ChronQC facilitates regular monitoring of clinical NGS to enable adherence to high quality clinical standards. ChronQC is freely available on GitHub (https://github.com/nilesh-tawari/ChronQC), Docker (https://hub.docker.com/r/nileshtawari/chronqc/) and the Python Package Index. ChronQC is implemented in Python and runs on all common operating systems (Windows, Linux and Mac OS X). tawari.nilesh@gmail.com or pauline.c.ng@gmail.com. Supplementary data are available at Bioinformatics online.

[Muscle relaxants and neuromuscular monitoring - Introduction for a safe clinical application].

PubMed

Döcker, Dennis; Walther, Andreas

2012-05-01

The use of muscle relaxants facilitates endotracheal intubation and ameliorates the conditions of surgery. But, their use should be controlled - otherwise there will be postoperative residual curarisation which can lead to patient discomfort up to severe medical complications. Therefore, an appropriate surveillance via objective neuromuscular monitoring is essential. This article gives a review of the basic principles of muscle relaxants, their clinical application and the surveillance of their effects and degradation. © Georg Thieme Verlag Stuttgart · New York.

Three-month validation of a turbuhaler electronic monitoring device: implications for asthma clinical trial use

PubMed Central

Pilcher, Janine; Shirtcliffe, Philippa; Patel, Mitesh; McKinstry, Steve; Cripps, Terrianne; Weatherall, Mark; Beasley, Richard

2015-01-01

Background Electronic monitoring of inhaled asthma therapy is suggested as the ‘gold standard’ for measuring patterns of medication use in clinical trials. The SmartTurbo (Adherium (NZ) Ltd, Auckland, New Zealand) is an electronic monitor for use with a turbuhaler device (AstraZeneca, UK). The aim of this study was to determine the accuracy of the SmartTurbo in recording Symbicort actuations over a 12-week period of use. Methods Twenty SmartTurbo monitors were attached to the base of 20 Symbicort turbuhalers. Bench testing in a research facility was undertaken on days 0, 5, 6, 7, 8, 9, 14, 21, 28, 56 and 84. Patterns of ‘low-use’ (2 sets of 2 actuations on the same day) and ‘high-use’ (2 sets of 8 actuations on the same day) were performed. The date and time of actuations were recorded in a paper diary and compared with data uploaded from the SmartTurbo monitors. Results 2800 actuations were performed. Monitor sensitivity was 99.9% with a lower 97.5% confidence bound of 99.6%. The positive predictive value was 99.9% with a 97.5% lower confidence bound of 99.7%. Accuracy was not affected by whether the pattern of inhaler use was low or high, or whether there was a delay in uploading the actuation data. Conclusions The SmartTurbo monitor is highly accurate in recording and retaining electronic data in this 12-week bench study. It can be recommended for use in clinical trial settings, in which quality control systems are incorporated into study protocols to ensure accurate data acquisition. PMID:26629345

Screening program for Waardenburg syndrome in Colombia: clinical definition and phenotypic variability.

PubMed

Tamayo, Marta L; Gelvez, Nancy; Rodriguez, Marcela; Florez, Silvia; Varon, Clara; Medina, David; Bernal, Jaime E

2008-04-15

A screening program to detect Waardenburg syndrome (WS) conducted between 2002 and 2005, among 1,763 deaf individuals throughout Columbia identified 95 affected individuals belonging to 95 families, giving a frequency of 5.38% of WS among the institutionalized deaf population. We confirmed the clinical diagnosis of WS in the 95 propositi and, through the family evaluation, we also identified 45 non-institutionalized affected relatives. Audiologic, ophthalmologic, and genetic studies were performed to confirm the diagnosis. Following the classification of the WS consortium, based on the Waardenburg Index (WI), to define the type of WS. We classified 62.1% of the propositi as WS2 and 37.9% as WS1. We present here the results of the study of clinical manifestations, analyzing the presence, severity, and symmetry of clinical findings among this affected population. Overall, among the 95 propositi, in addition to sensorineural deafness in all, the most frequent features were broad nasal root (58.9%), a first degree relative affected (37.9%), heterochromia irides (36.8%), skin hypopigmentation (31.6%), white forelock (28.0%), intense blue iris (27.4%), synophrys (12.6%), premature graying (10.5%), ptosis of the eyelids (9.5%), and hypoplasia alae nasi (1.1%). The majority of individuals had normal psychomotor development (87%), while the remaining 13% had developmental delay. Among the latter, 9.4% corresponded to WS2 and 3.6% to WS1. Our data confirm an interesting inter- and intrafamilial variability in the phenotypic manifestations as well as extremely variable expression. Copyright 2008 Wiley-Liss, Inc.

Monitoring of clinical signs in goats with transmissible spongiform encephalopathies

PubMed Central

2010-01-01

Background As there is limited information about the clinical signs of BSE and scrapie in goats, studies were conducted to describe the clinical progression of scrapie and BSE in goats and to evaluate a short clinical protocol for its use in detecting scrapie-affected goats in two herds with previously confirmed scrapie cases. Clinical assessments were carried out in five goats intracerebrally infected with the BSE agent as well as five reported scrapie suspects and 346 goats subject to cull from the two herds, 24 of which were retained for further monitoring. The brain and selected lymphoid tissue were examined by postmortem tests for disease confirmation. Results The sensitivity and specificity of the short clinical protocol in detecting a scrapie case in the scrapie-affected herds was 3.9% and 99.6%, respectively, based on the presence of tremor, positive scratch test, extensive hair loss, ataxia and absent menace response. All BSE- and scrapie-affected goats displayed abnormalities in sensation (over-reactivity to external stimuli, startle responses, pruritus, absent menace response) and movement (ataxia, tremor, postural deficits) at an advanced clinical stage but the first detectable sign associated with scrapie or BSE could vary between animals. Signs of pruritus were not always present despite similar prion protein genotypes. Clinical signs of scrapie were also displayed by two scrapie cases that presented with detectable disease-associated prion protein only in lymphoid tissues. Conclusions BSE and scrapie may present as pruritic and non-pruritic forms in goats. Signs assessed for the clinical diagnosis of scrapie or BSE in goats should include postural and gait abnormalities, pruritus and visual impairment. However, many scrapie cases will be missed if detection is solely based on the display of clinical signs. PrPd accumulation in the brain appeared to be related to the severity of clinical disease but not to the display of individual neurological signs

Cost Effectiveness Analysis of Clinically Driven versus Routine Laboratory Monitoring of Antiretroviral Therapy in Uganda and Zimbabwe

PubMed Central

Medina Lara, Antonieta; Kigozi, Jesse; Amurwon, Jovita; Muchabaiwa, Lazarus; Nyanzi Wakaholi, Barbara; Mujica Mota, Ruben E.; Walker, A. Sarah; Kasirye, Ronnie; Ssali, Francis; Reid, Andrew; Grosskurth, Heiner; Babiker, Abdel G.; Kityo, Cissy; Katabira, Elly; Munderi, Paula; Mugyenyi, Peter; Hakim, James; Darbyshire, Janet; Gibb, Diana M.; Gilks, Charles F.

2012-01-01

Background Despite funding constraints for treatment programmes in Africa, the costs and economic consequences of routine laboratory monitoring for efficacy and toxicity of antiretroviral therapy (ART) have rarely been evaluated. Methods Cost-effectiveness analysis was conducted in the DART trial (ISRCTN13968779). Adults in Uganda/Zimbabwe starting ART were randomised to clinically-driven monitoring (CDM) or laboratory and clinical monitoring (LCM); individual patient data on healthcare resource utilisation and outcomes were valued with primary economic costs and utilities. Total costs of first/second-line ART, routine 12-weekly CD4 and biochemistry/haematology tests, additional diagnostic investigations, clinic visits, concomitant medications and hospitalisations were considered from the public healthcare sector perspective. A Markov model was used to extrapolate costs and benefits 20 years beyond the trial. Results 3316 (1660LCM;1656CDM) symptomatic, immunosuppressed ART-naive adults (median (IQR) age 37 (32,42); CD4 86 (31,139) cells/mm3) were followed for median 4.9 years. LCM had a mean 0.112 year (41 days) survival benefit at an additional mean cost of $765 [95%CI:685,845], translating into an adjusted incremental cost of $7386 [3277,dominated] per life-year gained and $7793 [4442,39179] per quality-adjusted life year gained. Routine toxicity tests were prominent cost-drivers and had no benefit. With 12-weekly CD4 monitoring from year 2 on ART, low-cost second-line ART, but without toxicity monitoring, CD4 test costs need to fall below $3.78 to become cost-effective (<3xper-capita GDP, following WHO benchmarks). CD4 monitoring at current costs as undertaken in DART was not cost-effective in the long-term. Conclusions There is no rationale for routine toxicity monitoring, which did not affect outcomes and was costly. Even though beneficial, there is little justification for routine 12-weekly CD4 monitoring of ART at current test costs in low-income African

Who wants feedback? An investigation of the variables influencing residents' feedback-seeking behavior in relation to night shifts.

PubMed

Teunissen, Pim W; Stapel, Diederik A; van der Vleuten, Cees; Scherpbier, Albert; Boor, Klarke; Scheele, Fedde

2009-07-01

The literature on feedback in clinical medical education has predominantly treated trainees as passive recipients. Past research has focused on how clinical supervisors can use feedback to improve a trainee's performance. On the basis of research in social and organizational psychology, the authors reconceptualized residents as active seekers of feedback. They investigated what individual and situational variables influence residents' feedback-seeking behavior on night shifts. Early in 2008, the authors sent obstetrics-gynecology residents in the Netherlands--both those in their first two years of graduate training and those gaining experience between undergraduate and graduate training--a questionnaire that assessed four predictor variables (learning and performance goal orientation, and instrumental and supportive leadership), two mediator variables (perceived feedback benefits and costs), and two outcome variables (frequency of feedback inquiry and monitoring). They used structural equation modeling software to test a hypothesized model of relationships between variables. The response rate was 76.5%. Results showed that residents who perceive more feedback benefits report a higher frequency of feedback inquiry and monitoring. More perceived feedback costs result mainly in more feedback monitoring. Residents with a higher learning goal orientation perceive more feedback benefits and fewer costs. Residents with a higher performance goal orientation perceive more feedback costs. Supportive physicians lead residents to perceive more feedback benefits and fewer costs. This study showed that some residents actively seek feedback. Residents' feedback-seeking behavior partially depends on attending physicians' supervisory style. Residents' goal orientations influence their perceptions of the benefits and costs of feedback-seeking.

Continuous glucose monitoring and clinical trials.

PubMed

Heinemann, Lutz

2009-07-01

The use of glucose sensors during clinical trials seems like a great idea at first glance. Continuous glucose monitoring (CGM) should allow the gathering of more detailed information about metabolic control, without requiring much additional effort. In principle, CGM can reduce the duration of such studies and the number of participants required. The aim of this commentary is to highlight some of the reasons why, in practice, at least some of these hopes have not been realized. It is not only that a new technology requires extensive training of the study personnel; the practical handling of the devices and the time and effort required to download and analyze the data are often grossly underestimated initially. In addition, one must select the best endpoints for describing the level of metabolic control in view of the overwhelming amount of information provided by CGM. Several measures and endpoints were proposed as (potential) parameters that would be more meaningful than the standard parameters currently used to describe glucose profiles. Unfortunately, most of these proposed parameters have not, as yet, been proven to be more meaningful. Calibration is another critical aspect of using CGM that must be addressed. How this procedure is handled in practice has a profound impact on the quality of the glucose recordings. Finally, shall the current measurement results be displayed to the study participant or not? CGM can help prevent severe hypoglycemic episodes, but this can profoundly affect the study outcome in a manner that is unrelated to basic aim of the study (e.g., comparing medications that are designed to control glycemia). Therefore, the use of CGM in clinical trials requires much more careful consideration than was initially thought. Copyright 2009 Diabetes Technology Society.

Variable mechanical ventilation

PubMed Central

Fontela, Paula Caitano; Prestes, Renata Bernardy; Forgiarini Jr., Luiz Alberto; Friedman, Gilberto

2017-01-01

Objective To review the literature on the use of variable mechanical ventilation and the main outcomes of this technique. Methods Search, selection, and analysis of all original articles on variable ventilation, without restriction on the period of publication and language, available in the electronic databases LILACS, MEDLINE®, and PubMed, by searching the terms "variable ventilation" OR "noisy ventilation" OR "biologically variable ventilation". Results A total of 36 studies were selected. Of these, 24 were original studies, including 21 experimental studies and three clinical studies. Conclusion Several experimental studies reported the beneficial effects of distinct variable ventilation strategies on lung function using different models of lung injury and healthy lungs. Variable ventilation seems to be a viable strategy for improving gas exchange and respiratory mechanics and preventing lung injury associated with mechanical ventilation. However, further clinical studies are necessary to assess the potential of variable ventilation strategies for the clinical improvement of patients undergoing mechanical ventilation. PMID:28444076

Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders

PubMed Central

Kalali, Amir; West, Mark; Walling, David; Hilt, Dana; Engelhardt, Nina; Alphs, Larry; Loebel, Antony; Vanover, Kim; Atkinson, Sarah; Opler, Mark; Sachs, Gary; Nations, Kari; Brady, Chris

2016-01-01

This paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup analysis of current data quality monitoring techniques used in central nervous system (CNS) clinical trials. Based on audience polls conducted at the CNS Summit 2014, the panel determined that current techniques used to monitor data and quality in clinical trials are broad, uncontrolled, and lack independent verification. The majority of those polled endorse the value of monitoring data. Case examples of current data quality methodology are presented and discussed. Perspectives of pharmaceutical companies and trial sites regarding data quality monitoring are presented. Potential future developments in CNS data quality monitoring are described. Increased utilization of biomarkers as objective outcomes and for patient selection is considered to be the most impactful development in data quality monitoring over the next 10 years. Additional future outcome measures and patient selection approaches are discussed. PMID:27413584

Day-by-Day Variability of Home Blood Pressure and Incident Cardiovascular Disease in Clinical Practice: The J-HOP Study (Japan Morning Surge-Home Blood Pressure).

PubMed

Hoshide, Satoshi; Yano, Yuichiro; Mizuno, Hiroyuki; Kanegae, Hiroshi; Kario, Kazuomi

2018-01-01

We assessed the relationship between day-by-day home blood pressure (BP) variability and incident cardiovascular disease (CVD) in clinical practice. J-HOP study (Japan Morning Surge-Home Blood Pressure) participants underwent home BP monitoring in the morning and evening for a 14-day period, and their BP levels and BP variability independent of the mean (VIM) were assessed. Incident CVD events included coronary heart disease and stroke. Cox models were fitted to assess the home BP variability-CVD risk association. Among 4231 participants (mean±SD age, 64.9±10.9 years; 53.3% women; 79.1% taking antihypertensive medication), mean (SD) home systolic BP (SBP) levels over time and VIM SBP were 134.2 (14.3) and 6.8 (2.5) mm Hg, respectively. During a 4-year follow-up period (16 750.3 person-years), 148 CVD events occurred. VIM SBP was associated with CVD risk (hazard ratio per 1-SD increase, 1.32; 95% confidence interval [CI], 1.15-1.52), independently of mean home SBP levels over time and circulating B-type natriuretic peptide levels or urine albumin-to-creatinine ratio. Adding VIM SBP to the CVD prediction model improved the discrimination (C statistic, 0.785 versus 0.770; C statistic difference, 0.015; 95% CI, 0.003-0.028). Changes in continuous net reclassification improvement (0.259; 95% CI, 0.052-0.537), absolute integrated discrimination improvement (0.010; 95% CI, 0.003-0.016), and relative integrated discrimination improvement (0.104; 95% CI, 0.037-0.166) were also observed with the addition of VIM SBP to the CVD prediction models. In addition to the assessments of mean home SBP levels and cardiovascular end-organ damage, home BP variability measurements may provide a clinically useful distinction between high- and low-risk groups among Japanese outpatients. © 2017 American Heart Association, Inc.

Oxford Optronix MPM 3S: a clinical assessment of a microvascular perfusion monitor.

PubMed

Dryden, C M; Gray, W M; Asbury, A J

1992-01-01

The Oxford Optronix MPM 3S is a new microvascular perfusion monitor which is promoted as a device for use in the operating theatre. It uses a semiconductor laser diode and applies the Doppler principle to derive a semi-quantitative estimation of microvascular flow. We assessed this instrument with eight healthy volunteers who each performed eight different orthostatic arm manoeuvres while forearm skin blood flow was monitored. The different manoeuvres caused statistically significant changes in the instrument's reading which generally were consistent with expected changes in blood flow. The monitor also was assessed in the theatre environment with four anaesthetized patients. It proved easy to use, and was not subject to electrical interference from other equipment including short-wave diathermy. The major practical limitation of the technique is the semi-quantitative nature of the measurement. The instrument appears to have potential clinical uses in plastic and vascular surgery.

Design and Clinical Feasibility of Personal Wearable Monitor for Measurement of Activity and Environmental Exposure

PubMed Central

Ribón Fletcher, Richard; Oreskovic, Nicolas M.; Robinson, Alyssa I.

2015-01-01

Human exposure to specific environmental factors (e.g. air quality, lighting, and sound) is known to play an important role in the pathogenesis of many chronic diseases (e.g. asthma) and mental health disorders (e.g. anxiety). However, conventional fixed environmental monitoring stations are sparsely located and, despite environmental models, cannot adequately assess individual exposure levels. New forms of low-cost portable monitors have begun to emerge that enable the collection of higher spatial density “crowd sourced” data; however, the first generation of these low-cost environmental monitors have generally not been suitable for clinical environmental health studies due to practical challenges such as calibration, reproducibility, form factor, and battery life. In this paper, we present a wearable environmental monitor that overcomes these challenges and can be used in clinical studies The new device, called “Eco-Mini,” can be used without a smart phone and is capable of locally sampling and recording a variety of environmental parameters (Ozone, Sulfur Dioxide, Volatile Organic Compounds, humidity, temperature, ambient light color balance, and sound level) as well as individual activity (3-axis accelerometer) and location (GPS). In this paper, we also report findings and discuss lessons learned from a feasibility study conducted for one week with pediatric patients as part of an ongoing asthma research study. PMID:25570098

Exact tests using two correlated binomial variables in contemporary cancer clinical trials.

PubMed

Yu, Jihnhee; Kepner, James L; Iyer, Renuka

2009-12-01

New therapy strategies for the treatment of cancer are rapidly emerging because of recent technology advances in genetics and molecular biology. Although newer targeted therapies can improve survival without measurable changes in tumor size, clinical trial conduct has remained nearly unchanged. When potentially efficacious therapies are tested, current clinical trial design and analysis methods may not be suitable for detecting therapeutic effects. We propose an exact method with respect to testing cytostatic cancer treatment using correlated bivariate binomial random variables to simultaneously assess two primary outcomes. The method is easy to implement. It does not increase the sample size over that of the univariate exact test and in most cases reduces the sample size required. Sample size calculations are provided for selected designs.

Feasibility of noninvasive fetal electrocardiographic monitoring in a clinical setting.

PubMed

Arya, Bhawna; Govindan, Rathinaswamy; Krishnan, Anita; Duplessis, Adre; Donofrio, Mary T

2015-06-01

Cardiac rhythm is an essential component of fetal cardiac evaluation. The Monica AN24 is a fetal heart rate monitor that may provide a quick, inexpensive modality for obtaining a noninvasive fetal electrocardiogram (fECG) in a clinical setting. The fECG device has the ability to acquire fECG signals and allow calculation of fetal cardiac time intervals between 16- and 42-week gestational age (GA). We aimed to demonstrate the feasibility of fECG acquisition in a busy fetal cardiology clinic using the Monica fetal heart rate monitor. This is a prospective observational pilot study of fECG acquired from fetuses referred for fetal echocardiography. Recordings were performed for 5-15 min. Maternal signals were attenuated and fECG averaged. fECG and fetal cardiac time intervals (PR, QRS, RR, and QT) were evaluated by two cardiologists independently and inter-observer reliability was assessed using intraclass coefficient (ICC). Sixty fECGs were collected from 50 mothers (mean GA 28.1 ± 6.1). Adequate signal-averaged waveforms were obtained in 20 studies with 259 cardiac cycles. Waveforms could not be obtained between 26 and 30 weeks. Fetal cardiac time intervals were measured and were reproducible for PR (ICC = 0.89; CI 0.77-0.94), QRS (ICC = 0.79; CI 0.51-0.91), and RR (ICC = 0.77; CI 0.53-0.88). QT ICC was poor due to suboptimal T-wave tracings. Acquisition of fECG and measurement of fetal cardiac time intervals is feasible in a clinical setting between 19- and 42-week GA, though tracings are difficult to obtain, especially between 26 and 30 weeks. There was high reliability in fetal cardiac time intervals measurements, except for QT. The device may be useful for assessing atrioventricular/intraventricular conduction in fetuses from 20 to 26 and >30 weeks. Techniques to improve signal acquisition, namely T-wave amplification, are ongoing.

Design of a multi-site multi-state clinical trial of home monitoring of chronic disease in the community in Australia.

PubMed

Celler, Branko G; Sparks, Ross; Nepal, Surya; Alem, Leila; Varnfield, Marlien; Li, Jane; Jang-Jaccard, Julian; McBride, Simon J; Jayasena, Rajiv

2014-12-15

Telehealth services based on at-home monitoring of vital signs and the administration of clinical questionnaires are being increasingly used to manage chronic disease in the community, but few statistically robust studies are available in Australia to evaluate a wide range of health and socio-economic outcomes. The objectives of this study are to use robust statistical methods to research the impact of at home telemonitoring on health care outcomes, acceptability of telemonitoring to patients, carers and clinicians and to identify workplace cultural factors and capacity for organisational change management that will impact on large scale national deployment of telehealth services. Additionally, to develop advanced modelling and data analytics tools to risk stratify patients on a daily basis to automatically identify exacerbations of their chronic conditions. A clinical trial is proposed at five locations in five states and territories along the Eastern Seaboard of Australia. Each site will have 25 Test patients and 50 case matched control patients. All participants will be selected based on clinical criteria of at least two hospitalisations in the previous year or four or more admissions over the last five years for a range of one or more chronic conditions. Control patients are matched according to age, sex, major diagnosis and their Socio-Economic Indexes for Areas (SEIFA). The Trial Design is an Intervention control study based on the Before-After-Control-Impact (BACI) design. Our preliminary data indicates that most outcome variables before and after the intervention are not stationary, and accordingly we model this behaviour using linear mixed-effects (lme) models which can flexibly model within-group correlation often present in longitudinal data with repeated measures. We expect reduced incidence of unscheduled hospitalisation as well as improvement in the management of chronically ill patients, leading to better and more cost effective care. Advanced data

Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring.

PubMed

Stewart, J; Breslin, W J; Beyer, B K; Chadwick, K; De Schaepdrijver, L; Desai, M; Enright, B; Foster, W; Hui, J Y; Moffat, G J; Tornesi, B; Van Malderen, K; Wiesner, L; Chen, C L

2016-03-01

The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives.

Combining clinical and angiographic variables for estimating risk of target lesion revascularization after drug eluting stent placement.

PubMed

Stolker, Joshua M; Cohen, David J; Kennedy, Kevin F; Pencina, Michael J; Arnold, Suzanne V; Kleiman, Neal S; Spertus, John A

Drug-eluting stents (DES) reduce restenosis but require prolonged antiplatelet therapy, when compared with bare metal stents. Ideally, the patient should be involved in this risk:benefit assessment prior to selecting DES, to maximize the benefits and cost-effectiveness of care, and to improve medication adherence. However, accurate estimation of restenosis risk may require angiographic factors identified at cardiac catheterization. In a large PCI registry, we used logistic regression to identify clinical and angiographic predictors of clinically-driven target lesion revascularization (TLR) over the first year after stent placement. Discrimination c-statistic and integrated discrimination improvement (IDI) were used to calculate the incremental utility of angiographic variables when added to clinical predictors. Of 8501 PCI patients, TLR occurred in 4.5%. After adjusting for DES use, clinical TLR predictors were younger age, female sex, diabetes, prior PCI, and prior bypass surgery (model c-statistic 0.630). Angiographic predictors were vein graft PCI, in-stent restenosis lesion, longer stent length, and smaller stent diameter (c-statistic 0.650). After adding angiographic factors to the clinical model, c-statistic improved to 0.680 and the average separation in TLR risk among patients with and without TLR improved by 1% (IDI=0.010, 95% CI 0.009-0.014), primarily driven by those experiencing TLR (from 5.9% to 6.9% absolute risk). Among unselected PCI patients, the incidence of clinically-indicated TLR is <5% at 1-year, and standard clinical variables only moderately discriminate who will and will not experience TLR. Angiographic variables significantly improve TLR risk assessment, suggesting that stent selection may be best performed after coronary anatomy has been delineated. Although several recent studies have challenged traditional expectations regarding the duration of dual antiplatelet therapy, current guidelines recommend at least 6 to 12months of treatment

Association of glycaemic variability evaluated by continuous glucose monitoring with diabetic peripheral neuropathy in type 2 diabetic patients.

PubMed

Hu, Yu-Ming; Zhao, Li-Hua; Zhang, Xiu-Lin; Cai, Hong-Li; Huang, Hai-Yan; Xu, Feng; Chen, Tong; Wang, Xue-Qin; Guo, Ai-Song; Li, Jian-An; Su, Jian-Bin

2018-05-01

Diabetic peripheral neuropathy (DPN), a common microvascular complication of diabetes, is linked to glycaemic derangements. Glycaemic variability, as a pattern of glycaemic derangements, is a key risk factor for diabetic complications. We investigated the association of glycaemic variability with DPN in a large-scale sample of type 2 diabetic patients. In this cross-sectional study, we enrolled 982 type 2 diabetic patients who were screened for DPN and monitored by a continuous glucose monitoring (CGM) system between February 2011 and January 2017. Multiple glycaemic variability parameters, including the mean amplitude of glycaemic excursions (MAGE), mean of daily differences (MODD), standard deviation of glucose (SD), and 24-h mean glucose (24-h MG), were calculated from glucose profiles obtained from CGM. Other possible risks for DPN were also examined. Of the recruited type 2 diabetic patients, 20.1% (n = 197) presented with DPN, and these patients also had a higher MAGE, MODD, SD, and 24-h MG than patients without DPN (p < 0.001). Using univariate and multiple logistic regression analyses, MAGE and conventional risks including diabetic duration, HOMA-IR, and hemoglobin A1c (HbA1c) were found to be independent contributors to DPN, and the corresponding odds ratios (95% confidence interval) were 4.57 (3.48-6.01), 1.10 (1.03-1.17), 1.24 (1.09-1.41), and 1.33 (1.15-1.53), respectively. Receiver operating characteristic analysis indicated that the optimal MAGE cutoff value for predicting DPN was 4.60 mmol/L; the corresponding sensitivity was 64.47%, and the specificity was 75.54%. In addition to conventional risks including diabetic duration, HOMA-IR and HbA1c, increased glycaemic variability assessed by MAGE is a significant independent contributor to DPN in type 2 diabetic patients.

Variable Accuracy of Wearable Heart Rate Monitors during Aerobic Exercise.

PubMed

Gillinov, Stephen; Etiwy, Muhammad; Wang, Robert; Blackburn, Gordon; Phelan, Dermot; Gillinov, A Marc; Houghtaling, Penny; Javadikasgari, Hoda; Desai, Milind Y

2017-08-01

Athletes and members of the public increasingly rely on wearable HR monitors to guide physical activity and training. The accuracy of newer, optically based monitors is unconfirmed. We sought to assess the accuracy of five optically based HR monitors during various types of aerobic exercise. Fifty healthy adult volunteers (mean ± SD age = 38 ± 12 yr, 54% female) completed exercise protocols on a treadmill, a stationary bicycle, and an elliptical trainer (±arm movement). Each participant underwent HR monitoring with an electrocardiogaphic chest strap monitor (Polar H7), forearm monitor (Scosche Rhythm+), and two randomly assigned wrist-worn HR monitors (Apple Watch, Fitbit Blaze, Garmin Forerunner 235, and TomTom Spark Cardio), one on each wrist. For each exercise type, HR was recorded at rest, light, moderate, and vigorous intensity. Agreement between HR measurements was assessed using Lin's concordance correlation coefficient (rc). Across all exercise conditions, the chest strap monitor (Polar H7) had the best agreement with ECG (rc = 0.996) followed by the Apple Watch (rc = 0.92), the TomTom Spark (rc = 0.83), and the Garmin Forerunner (rc = 0.81). Scosche Rhythm+ and Fitbit Blaze were less accurate (rc = 0.75 and rc = 0.67, respectively). On treadmill, all devices performed well (rc = 0.88-0.93) except the Fitbit Blaze (rc = 0.76). While bicycling, only the Garmin, Apple Watch, and Scosche Rhythm+ had acceptable agreement (rc > 0.80). On the elliptical trainer without arm levers, only the Apple Watch was accurate (rc = 0.94). None of the devices was accurate during elliptical trainer use with arm levers (all rc < 0.80). The accuracy of wearable, optically based HR monitors varies with exercise type and is greatest on the treadmill and lowest on elliptical trainer. Electrode-containing chest monitors should be used when accurate HR measurement is imperative.

Vital signs monitoring on general wards: clinical staff perceptions of current practices and the planned introduction of continuous monitoring technology.

PubMed

Prgomet, Mirela; Cardona-Morrell, Magnolia; Nicholson, Margaret; Lake, Rebecca; Long, Janet; Westbrook, Johanna; Braithwaite, Jeffrey; Hillman, Ken

2016-09-01

Early detection of patient deterioration and prevention of adverse events are key challenges to patient safety. This study investigated clinical staff perceptions of current monitoring practices and the planned introduction of continuous monitoring devices on general wards. Multi-method study comprising structured surveys, in-depth interviews and device trial with log book feedback. Two general wards in a large urban teaching hospital in Sydney, Australia. Respiratory and neurosurgery nursing staff and two doctors. Nurses were confident about their abilities to identify patients at risk of deterioration, using a combination of vital signs and visual assessment. There were concerns about the accuracy of current vital signs monitoring equipment and frequency of intermittent observation. Both the nurses and the doctors were enthusiastic about the prospect of continuous monitoring and perceived it would allow earlier identification of patient deterioration; provide reassurance to patients; and support interdisciplinary communication. There were also reservations about continuous monitoring, including potential decrease in bedside nurse-patient interactions; increase in inappropriate escalations of patient care; and discomfort to patients. While continuous monitoring devices were seen as a potentially positive tool to support the identification of patient deterioration, drawbacks, such as the potential for reduced patient contact, revealed key areas that will require close surveillance following the implementation of devices. Training and improved interdisciplinary communication were identified as key requisites for successful implementation. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Feasibility and validity of computerized ambulatory monitoring in stroke patients.

PubMed

Johnson, E I; Sibon, I; Renou, P; Rouanet, F; Allard, M; Swendsen, J

2009-11-10

Computerized ambulatory monitoring provides real-time assessments of clinical outcomes in natural contexts, and it has been increasingly applied in recent years to investigate symptom expression in a wide range of disorders. The purpose of this study was to examine the feasibility and validity of this data collection strategy with adult stroke patients. Forty-eight individuals (75% of the contacted sample) agreed to participate in the current study and were instructed to complete electronic interviews using a personal digital assistant 5 times per day over a 1-week period. More than 80% of programmed assessments were completed by the sample, and no evidence was found for fatigue effects. Expected patterns of associations were observed among daily life variables, and data collected through ambulatory monitoring were significantly correlated with standard clinic-based measures of similar constructs. Support was found for the feasibility and validity of computerized ambulatory monitoring with stroke patients. The application of these novel methods with stroke patients should provide complementary information that is inaccessible to standard hospital-based assessments and permit increased understanding of the significance of clinical results and test scores for daily life experience.

Renal function monitoring in heart failure – what is the optimal frequency? A narrative review

PubMed Central

Wright, David; Devonald, Mark Alexander John; Pirmohamed, Munir

2017-01-01

The second most common cause of hospitalization due to adverse drug reactions in the UK is renal dysfunction due to diuretics, particularly in patients with heart failure, where diuretic therapy is a mainstay of treatment regimens. Therefore, the optimal frequency for monitoring renal function in these patients is an important consideration for preventing renal failure and hospitalization. This review looks at the current evidence for optimal monitoring practices of renal function in patients with heart failure according to national and international guidelines on the management of heart failure (AHA/NICE/ESC/SIGN). Current guidance of renal function monitoring is in large part based on expert opinion, with a lack of clinical studies that have specifically evaluated the optimal frequency of renal function monitoring in patients with heart failure. Furthermore, there is variability between guidelines, and recommendations are typically nonspecific. Safer prescribing of diuretics in combination with other antiheart failure treatments requires better evidence for frequency of renal function monitoring. We suggest developing more personalized monitoring rather than from the current medication‐based guidance. Such flexible clinical guidelines could be implemented using intelligent clinical decision support systems. Personalized renal function monitoring would be more effective in preventing renal decline, rather than reacting to it. PMID:28901643

Clinical applications of commercially available video recording and monitoring systems: inexpensive, high-quality video recording and monitoring systems for endoscopy and microsurgery.

PubMed

Tsunoda, Koichi; Tsunoda, Atsunobu; Ishimoto, ShinnIchi; Kimura, Satoko

2006-01-01

The exclusive charge-coupled device (CCD) camera system for the endoscope and electronic fiberscopes are in widespread use. However, both are usually stationary in an office or examination room, and a wheeled cart is needed for mobility. The total costs of the CCD camera system and electronic fiberscopy system are at least US Dollars 10,000 and US Dollars 30,000, respectively. Recently, the performance of audio and visual instruments has improved dramatically, with a concomitant reduction in their cost. Commercially available CCD video cameras with small monitors have become common. They provide excellent image quality and are much smaller and less expensive than previous models. The authors have developed adaptors for the popular mini-digital video (mini-DV) camera. The camera also provides video and acoustic output signals; therefore, the endoscopic images can be viewed on a large monitor simultaneously. The new system (a mini-DV video camera and an adaptor) costs only US Dollars 1,000. Therefore, the system is both cost-effective and useful for the outpatient clinic or casualty setting, or on house calls for the purpose of patient education. In the future, the authors plan to introduce the clinical application of a high-vision camera and an infrared camera as medical instruments for clinical and research situations.

Monitoring pasture variability: optical OptRx(®) crop sensor versus Grassmaster II capacitance probe.

PubMed

Serrano, João M; Shahidian, Shakib; Marques da Silva, José Rafael

2016-02-01

Estimation of pasture productivity is an important step for the farmer in terms of planning animal stocking, organizing animal lots, and determining supplementary feeding needs throughout the year. The main objective of this work was to evaluate technologies which have potential for monitoring aspects related to spatial and temporal variability of pasture green and dry matter yield (respectively, GM and DM, in kg/ha) and support to decision making for the farmer. Two types of sensors were evaluated: an active optical sensor ("OptRx(®)," which measures the NDVI, "Normalized Difference Vegetation Index") and a capacitance probe ("GrassMaster II" which estimates plant mass). The results showed the potential of NDVI for monitoring the evolution of spatial and temporal patterns of vegetative growth of biodiverse pasture. Higher NDVI values were registered as pasture approached its greatest vegetative vigor, with a significant fall in the measured NDVI at the end of Spring, when the pasture began to dry due to the combination of higher temperatures and lower soil moisture content. This index was also effective for identifying different plant species (grasses/legumes) and variability in pasture yield. Furthermore, it was possible to develop calibration equations between the capacitance and the NDVI (R(2) = 0.757; p < 0.01), between capacitance and GM (R(2) = 0.799; p < 0.01), between capacitance and DM (R(2) =0.630; p < 0.01), between NDVI and GM (R(2) = 0.745; p < 0.01), and between capacitance and DM (R(2) = 0.524; p < 0.01). Finally, a direct relationship was obtained between NDVI and pasture moisture content (PMC, in %) and between capacitance and PMC (respectively, R(2) = 0.615; p < 0.01 and R(2) = 0.561; p < 0.01) in Alentejo dryland farming systems.

Patient, Treatment, and Health Care Utilization Variables Associated with Adherence to Metabolic Monitoring Practices in Children and Adolescents Taking Second-Generation Antipsychotics.

PubMed

Coughlin, Mary; Goldie, Catherine Lindsay; Tranmer, Joan; Khalid-Khan, Sarosh; Tregunno, Deborah

2018-04-01

Children and adolescents with a range of psychiatric disorders are increasingly being prescribed atypical or second-generation antipsychotics (SGAs). While SGAs are effective at treating conduct and behavioural symptoms, they infer significant cardiometabolic risk. This study aims to explore what patient, treatment, and health care utilization variables are associated with adherence to Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children (CAMESA) metabolic monitoring guidelines. A retrospective chart review of 294 children and adolescents accessing a large outpatient psychiatry setting within a 2-year study period (2014-2016) was conducted. Baseline and follow-up metabolic monitoring, demographic, treatment, and health care utilization variables were then assessed over a 1-year period of interest. Metabolic monitoring practices did not adhere to CAMESA guidelines and were very poor over the 1-year observation period. There were significant differences between children (ages 4-12 years, n = 99) and adolescents (ages 13-18 years, n = 195). In adolescents, factors associated with any baseline metabolic monitoring were a higher number of psychiatry visits (odds ratio [OR], 1.2; 95% confidence interval [CI], 1.10 to 1.41), longer duration of contact (OR, 14; 95% CI, 2.31 to 82.4), and use of other non-SGA medications (OR, 3.2; 95% CI, 1.17 to 8.94). Among children, having an emergency room visit (OR, 3.4; 95% CI, 1.01 to 11.71) and taking aripiprazole (OR, 7.4; 95% CI, 2.02 to 27.45) increased the odds of receiving baseline metabolic monitoring. Findings from this study highlight the need for better metabolic monitoring for children and adolescents taking SGAs. Enhanced focus on opportunities for multidisciplinary collaboration is needed to improve the quality of care offered to this population.

Latent class instrumental variables: a clinical and biostatistical perspective.

PubMed

Baker, Stuart G; Kramer, Barnett S; Lindeman, Karen S

2016-01-15

In some two-arm randomized trials, some participants receive the treatment assigned to the other arm as a result of technical problems, refusal of a treatment invitation, or a choice of treatment in an encouragement design. In some before-and-after studies, the availability of a new treatment changes from one time period to this next. Under assumptions that are often reasonable, the latent class instrumental variable (IV) method estimates the effect of treatment received in the aforementioned scenarios involving all-or-none compliance and all-or-none availability. Key aspects are four initial latent classes (sometimes called principal strata) based on treatment received if in each randomization group or time period, the exclusion restriction assumption (in which randomization group or time period is an instrumental variable), the monotonicity assumption (which drops an implausible latent class from the analysis), and the estimated effect of receiving treatment in one latent class (sometimes called efficacy, the local average treatment effect, or the complier average causal effect). Since its independent formulations in the biostatistics and econometrics literatures, the latent class IV method (which has no well-established name) has gained increasing popularity. We review the latent class IV method from a clinical and biostatistical perspective, focusing on underlying assumptions, methodological extensions, and applications in our fields of obstetrics and cancer research. Copyright © 2015 John Wiley & Sons, Ltd.

Latent class instrumental variables: A clinical and biostatistical perspective

PubMed Central

Baker, Stuart G.; Kramer, Barnett S.; Lindeman, Karen S.

2015-01-01

In some two-arm randomized trials, some participants receive the treatment assigned to the other arm as a result of technical problems, refusal of a treatment invitation, or a choice of treatment in an encouragement design. In some before-and-after studies, the availability of a new treatment changes from one time period to this next. Under assumptions that are often reasonable, the latent class instrumental variable (IV) method estimates the effect of treatment received in the aforementioned scenarios involving all-or-none compliance and all-or-none availability. Key aspects are four initial latent classes (sometimes called principal strata) based on treatment received if in each randomization group or time period, the exclusion restriction assumption (in which randomization group or time period is an instrumental variable), the monotonicity assumption (which drops an implausible latent class from the analysis), and the estimated effect of receiving treatment in one latent class (sometimes called efficacy, the local average treatment effect, or the complier average causal effect). Since its independent formulations in the biostatistics and econometrics literatures, the latent class IV method (which has no well-established name) has gained increasing popularity. We review the latent class IV method from a clinical and biostatistical perspective, focusing on underlying assumptions, methodological extensions, and applications in our fields of obstetrics and cancer research. PMID:26239275

A Bayesian prediction model between a biomarker and the clinical endpoint for dichotomous variables.

PubMed

Jiang, Zhiwei; Song, Yang; Shou, Qiong; Xia, Jielai; Wang, William

2014-12-20

Early biomarkers are helpful for predicting clinical endpoints and for evaluating efficacy in clinical trials even if the biomarker cannot replace clinical outcome as a surrogate. The building and evaluation of an association model between biomarkers and clinical outcomes are two equally important concerns regarding the prediction of clinical outcome. This paper is to address both issues in a Bayesian framework. A Bayesian meta-analytic approach is proposed to build a prediction model between the biomarker and clinical endpoint for dichotomous variables. Compared with other Bayesian methods, the proposed model only requires trial-level summary data of historical trials in model building. By using extensive simulations, we evaluate the link function and the application condition of the proposed Bayesian model under scenario (i) equal positive predictive value (PPV) and negative predictive value (NPV) and (ii) higher NPV and lower PPV. In the simulations, the patient-level data is generated to evaluate the meta-analytic model. PPV and NPV are employed to describe the patient-level relationship between the biomarker and the clinical outcome. The minimum number of historical trials to be included in building the model is also considered. It is seen from the simulations that the logit link function performs better than the odds and cloglog functions under both scenarios. PPV/NPV ≥0.5 for equal PPV and NPV, and PPV + NPV ≥1 for higher NPV and lower PPV are proposed in order to predict clinical outcome accurately and precisely when the proposed model is considered. Twenty historical trials are required to be included in model building when PPV and NPV are equal. For unequal PPV and NPV, the minimum number of historical trials for model building is proposed to be five. A hypothetical example shows an application of the proposed model in global drug development. The proposed Bayesian model is able to predict well the clinical endpoint from the observed biomarker

Monitoring of Intracranial Pressure in Meningitis.

PubMed

Depreitere, Bart; Bruyninckx, Dominike; Güiza, Fabian

2016-01-01

The literature on intracranial pressure (ICP) monitoring in meningitis is limited to case reports and a handful of descriptive series. The aim of this study is to investigate relationships among ICP, cerebral perfusion pressure (CPP), and outcome in meningitis and to identify whether ICP affected clinical decisions. Between 1999 and 2011, a total of 17 patients with meningitis underwent ICP monitoring at the University Hospitals Leuven. Charts were reviewed for clinical history, ICP/CPP data, imaging findings, and Glasgow Outcome Scale score. Univariate correlations were computed for outcome and ICP/CPP variables, computed tomography characteristics, and Corticosteroid Randomization After Significant Head Injury outcome model variables. Treatment decisions were assessed regarding whether or not they were based on ICP. At drain placement, Glasgow Coma Scale scores showed a median of 8 (range 3-12). Six of 17 patients had either one or two nonreactive pupils. Significant correlations with outcome were found for the highest documented ICP value (r = -0.70), the number of episodes when CPP <50 mmHg (r =-0.50), the lowest documented CPP value (r = 0.61), and pupil reactivity (r = 0.57). Treatment was influenced by ICP in all patients. The results support the notion that in meningitis high ICP and low CPP represent secondary insults. The poor condition of the patients illustrates that the level of suspicion for increased ICP in meningitis may not be high enough.

Fiber optic video monitoring system for remote CT/MR scanners clinically accepted

NASA Astrophysics Data System (ADS)

Tecotzky, Raymond H.; Bazzill, Todd M.; Eldredge, Sandra L.; Tagawa, James; Sayre, James W.

1992-07-01

With the proliferation of CT travel to distant scanners to review images before their patients can be released. We designed a fiber-optic broadband video system to transmit images from seven scanner consoles to fourteen remote monitoring stations in real time. This system has been used clinically by radiologists for over one years. We designed and conducted a user survey to categorize the levels of system use by section (Chest, GI, GU, Bone, Neuro, Peds, etc.), to measure operational utilization and acceptance of the system into the clinical environment, to clarify the system''s importance as a clinical tool for saving radiologists travel-time to distant CT the system''s performance and limitations as a diagnostic tool. The study was administered directly to radiologists using a printed survey form. The results of the survey''s compiled data show a high percentage of system usage by a wide spectrum of radiologists. Clearly, this system has been accepted into the clinical environment as a highly valued diagnostic tool in terms of time savings and functional flexibility.

Assessing hospitals' clinical risk management: Development of a monitoring instrument

PubMed Central

2010-01-01

Background Clinical risk management (CRM) plays a crucial role in enabling hospitals to identify, contain, and manage risks related to patient safety. So far, no instruments are available to measure and monitor the level of implementation of CRM. Therefore, our objective was to develop an instrument for assessing CRM in hospitals. Methods The instrument was developed based on a literature review, which identified key elements of CRM. These elements were then discussed with a panel of patient safety experts. A theoretical model was used to describe the level to which CRM elements have been implemented within the organization. Interviews with CRM practitioners and a pilot evaluation were conducted to revise the instrument. The first nationwide application of the instrument (138 participating Swiss hospitals) was complemented by in-depth interviews with 25 CRM practitioners in selected hospitals, for validation purposes. Results The monitoring instrument consists of 28 main questions organized in three sections: 1) Implementation and organizational integration of CRM, 2) Strategic objectives and operational implementation of CRM at hospital level, and 3) Overview of CRM in different services. The instrument is available in four languages (English, German, French, and Italian). It allows hospitals to gather comprehensive and systematic data on their CRM practice and to identify areas for further improvement. Conclusions We have developed an instrument for assessing development stages of CRM in hospitals that should be feasible for a continuous monitoring of developments in this important area of patient safety. PMID:21144039

Use of structured decision making to identify monitoring variables and management priorities for salt marsh ecosystems

USGS Publications Warehouse

Neckles, Hilary A.; Lyons, James E.; Guntenspergen, Glenn R.; Shriver, W. Gregory; Adamowicz, Susan C.

2015-01-01

Most salt marshes in the USA have been degraded by human activities, and coastal managers are faced with complex choices among possible actions to restore or enhance ecosystem integrity. We applied structured decision making (SDM) to guide selection of monitoring variables and management priorities for salt marshes within the National Wildlife Refuge System in the northeastern USA. In general, SDM is a systematic process for decomposing a decision into its essential elements. We first engaged stakeholders in clarifying regional salt marsh decision problems, defining objectives and attributes to evaluate whether objectives are achieved, and developing a pool of alternative management actions for achieving objectives. Through this process, we identified salt marsh attributes that were applicable to monitoring National Wildlife Refuges on a regional scale and that targeted management needs. We then analyzed management decisions within three salt marsh units at Prime Hook National Wildlife Refuge, coastal Delaware, as a case example of prioritizing management alternatives. Values for salt marsh attributes were estimated from 2 years of baseline monitoring data and expert opinion. We used linear value modeling to aggregate multiple attributes into a single performance score for each alternative, constrained optimization to identify alternatives that maximized total management benefits subject to refuge-wide cost constraints, and used graphical analysis to identify the optimal set of alternatives for the refuge. SDM offers an efficient, transparent approach for integrating monitoring into management practice and improving the quality of management decisions.

Improvement in safety monitoring of biologic response modifiers after the implementation of clinical care guidelines by a specialty.

PubMed

Hanson, Rebekah L; Gannon, Michael J; Khamo, Nehrin; Sodhi, Monsheel; Orr, Alexander M; Stubbings, JoAnn

2013-01-01

Tumor necrosis factor (TNF)-alpha inhibitors and other biologic response modifiers (BRMs) are frequently used to treat a variety of inflammatory diseases. Use of these agents may increase risk of serious infections, malignancies, and other complications such as worsening symptoms of heart failure or demyelinating disease. Because of these risks, a baseline assessment and routine monitoring have been recommended, but standardized guidelines for monitoring have yet to be established. To measure the compliance with the recommended safety monitoring in the Clinical Care Guidelines for BRMs at the University of Illinois Hospitals and Health Sciences System (UI Health). The Clinical Care Guidelines for BRMs was developed by a committee of pharmacists, nurses, and physicians based on an assessment of published literature and medication labeling. The guidelines included recommendations for safety monitoring prior to BRM therapy, such as the tuberculosis (TB) test, Hepatitis B surface Antigen (HBsAg) test, liver function test (LFT), complete blood count (CBC), up-to-date vaccinations, risk assessment for cancer, pregnancy testing, monitoring for contraindications with concomitant medications, concomitant disease state risk assessment, and patient education. The guidelines were introduced to UI Health in February 2012 by a systemwide email and by in-services given by the health system's Specialty Pharmacy Service. In-services were given in the clinics known to generate large numbers of BRM orders (e.g., gastroenterology and rheumatology) and at the outpatient center for infused therapies. The purpose of the in-services was to introduce providers to the guidelines and encourage their compliance. To ensure that guideline requirements were met when BRMs were ordered, a process was established to identify BRM orders, assess the orders for compliance with 4 of the safety monitoring tests from the guidelines (TB, HBsAg, LFT, and CBC), and make interventions. When necessary

Monitoring multiple species: Estimating state variables and exploring the efficacy of a monitoring program

USGS Publications Warehouse

Mattfeldt, S.D.; Bailey, L.L.; Grant, E.H.C.

2009-01-01

Monitoring programs have the potential to identify population declines and differentiate among the possible cause(s) of these declines. Recent criticisms regarding the design of monitoring programs have highlighted a failure to clearly state objectives and to address detectability and spatial sampling issues. Here, we incorporate these criticisms to design an efficient monitoring program whose goals are to determine environmental factors which influence the current distribution and measure change in distributions over time for a suite of amphibians. In designing the study we (1) specified a priori factors that may relate to occupancy, extinction, and colonization probabilities and (2) used the data collected (incorporating detectability) to address our scientific questions and adjust our sampling protocols. Our results highlight the role of wetland hydroperiod and other local covariates in the probability of amphibian occupancy. There was a change in overall occupancy probabilities for most species over the first three years of monitoring. Most colonization and extinction estimates were constant over time (years) and space (among wetlands), with one notable exception: local extinction probabilities for Rana clamitans were lower for wetlands with longer hydroperiods. We used information from the target system to generate scenarios of population change and gauge the ability of the current sampling to meet monitoring goals. Our results highlight the limitations of the current sampling design, emphasizing the need for long-term efforts, with periodic re-evaluation of the program in a framework that can inform management decisions.

Clinical Variables Associated with Hydration Status in Acute Ischemic Stroke Patients with Dysphagia.

PubMed

Crary, Michael A; Carnaby, Giselle D; Shabbir, Yasmeen; Miller, Leslie; Silliman, Scott

2016-02-01

Acute stroke patients with dysphagia are at increased risk for poor hydration. Dysphagia management practices may directly impact hydration status. This study examined clinical factors that might impact hydration status in acute ischemic stroke patients with dysphagia. A retrospective chart review was completed on 67 ischemic stroke patients who participated in a prior study of nutrition and hydration status during acute care. Prior results indicated that patients with dysphagia demonstrated elevated BUN/Cr compared to non-dysphagia cases during acute care and that BUN/Cr increased selectively in dysphagic patients. This chart review evaluated clinical variables potentially impacting hydration status: diuretics, parenteral fluids, tube feeding, oral diet, and nonoral (NPO) status. Exposure to any variable and number of days of exposure to each variable were examined. Dysphagia cases demonstrated significantly more NPO days, tube fed days, and parenteral fluid days, but not oral fed days, or days on diuretics. BUN/Cr values at discharge were not associated with NPO days, parenteral fluid days, oral fed days, or days on diuretics. Patients on modified solid diets had significantly higher mean BUN/Cr values at discharge (27.12 vs. 17.23) as did tube fed patients (28.94 vs. 18.66). No difference was noted between these subgroups at baseline (regular diet vs. modified solids diets). Any modification of solid diets (31.11 vs. 17.23) or thickened liquids (28.50 vs. 17.81) resulted in significantly elevated BUN/Cr values at discharge. Liquid or diet modifications prescribed for acute stroke patients with dysphagia may impair hydration status in these patients.

Clinical and non-clinical depression and anxiety in young people: A scoping review on heart rate variability.

PubMed

Paniccia, Melissa; Paniccia, David; Thomas, Scott; Taha, Tim; Reed, Nick

2017-12-01

Heart rate variability (HRV), a measure of cardiac autonomic nervous system functioning, has emerged as a physiological indicator for emotional regulation and psychological well-being. HRV is understudied in the context of depression and anxiety in young people (10-24years old). Main objectives: (1) describe the nature and breadth of reviewed studies; and (2) synthesize main findings in the context of clinical and non-clinical populations of young people with depression and/or anxiety. The Arksey and O'Malley methodology was utilized for this scoping review. CINHAL, EMBASE, Medline, PsychInfo, Scopus, Web of Science, as well as grey literature, were searched. Two reviewers screened titles, abstracts and full papers for inclusion. A total of 20 citations were included in the final review (19 citations peer-reviewed journal articles, 1 journal abstract). Numerical and thematic analysis was used to summarize study findings. In clinical populations of either depression or anxiety, HRV was lower compared to controls. In non-clinical populations of either depression or anxiety, HRV was found to be lower in those who reported more depression or anxiety symptoms. The quality of the reviewed articles was not assessed which limits the ability to generate conclusions regarding study findings. Changes in HRV were found across the spectrum of clinical and non-clinical populations of young people with depression or anxiety. Neurophysiological research on depression and anxiety in young people can act as a first step to understanding how physiological flexibility (i.e. HRV) is related to psychological flexibility (i.e. adaptive or maladaptive responses to life events). Copyright © 2017 Elsevier B.V. All rights reserved.

Clinical Significance of Mobile Health Assessed Sleep Duration and Variability in Bipolar Disorder

PubMed Central

Kaufmann, Christopher N.; Gershon, Anda; Eyler, Lisa T.; Depp, Colin A.

2016-01-01

OBJECTIVE Sleep disturbances are prevalent, persistent, and impairing features of bipolar disorder. However, the near-term and cumulative impact of the severity and variability of sleep disturbances on symptoms and functioning remains unclear. We examined self-reported daily sleep duration and variability in relation to mood symptoms, medication adherence, cognitive functioning, and concurrent daily affect. METHODS Forty-one outpatients diagnosed with bipolar disorder were asked to provide daily reports of sleep duration and affect collected via ecological momentary assessment with smartphones over eleven weeks. Measures of depressive and manic symptoms, medication adherence, and cognitive function were collected at baseline and concurrent assessment of affect were collected daily. Analyses examined whether sleep duration or variability were associated with baseline measures and changes in same-day or next-day affect. RESULTS Greater sleep duration variability (but not average sleep duration) was associated with greater depressive and manic symptom severity, and lower medication adherence at baseline, and with lower and more variable ratings of positive affect and higher ratings of negative affect. Sleep durations shorter than 7-8 hours were associated with lower same-day ratings of positive and higher same-day ratings of negative affect, however this did not extend to next-day affect. CONCLUSIONS Greater cumulative day-to-day sleep duration variability, but not average sleep duration, was related to more severe mood symptoms, lower self-reported medication adherence and higher levels of negative affect. Bouts of short- or long-duration sleep had transient impact on affect. Day-to-day sleep variability may be important to incorporate into clinical assessment of sleep disturbances in bipolar disorder. PMID:27451108

Clinical significance of mobile health assessed sleep duration and variability in bipolar disorder.

PubMed

Kaufmann, Christopher N; Gershon, Anda; Eyler, Lisa T; Depp, Colin A

2016-10-01

Sleep disturbances are prevalent, persistent, and impairing features of bipolar disorder. However, the near-term and cumulative impact of the severity and variability of sleep disturbances on symptoms and functioning remains unclear. We examined self-reported daily sleep duration and variability in relation to mood symptoms, medication adherence, cognitive functioning, and concurrent daily affect. Forty-one outpatients diagnosed with bipolar disorder were asked to provide daily reports of sleep duration and affect collected via ecological momentary assessment with smartphones over eleven weeks. Measures of depressive and manic symptoms, medication adherence, and cognitive function were collected at baseline and concurrent assessment of affect were collected daily. Analyses examined whether sleep duration or variability were associated with baseline measures and changes in same-day or next-day affect. Greater sleep duration variability (but not average sleep duration) was associated with greater depressive and manic symptom severity, and lower medication adherence at baseline, and with lower and more variable ratings of positive affect and higher ratings of negative affect. Sleep durations shorter than 7-8 h were associated with lower same-day ratings of positive and higher same-day ratings of negative affect, however this did not extend to next-day affect. Greater cumulative day-to-day sleep duration variability, but not average sleep duration, was related to more severe mood symptoms, lower self-reported medication adherence and higher levels of negative affect. Bouts of short- or long-duration sleep had transient impact on affect. Day-to-day sleep variability may be important to incorporate into clinical assessment of sleep disturbances in bipolar disorder. Copyright © 2016 Elsevier Ltd. All rights reserved.

Remote Monitoring to Reduce Heart Failure Readmissions.

PubMed

Emani, Sitaramesh

2017-02-01

Rehospitalization for heart failure remains a challenge in the treatment of affected patients. The ability to remotely monitor patients for worsening heart failure may provide an avenue through which therapeutic interventions can be made to prevent a rehospitalization. Available data on remote monitoring to reduce heart failure rehospitalizations are reviewed within. Strategies to reduce readmissions include clinical telemonitoring, bioimpedance changes, biomarkers, and remote hemodynamic monitoring. Telemonitoring is readily available, but has low sensitivity and adherence. No data exist to demonstrate the efficacy of this strategy in reducing admissions. Bioimpedance offers improved sensitivity compared to telemonitoring, but has not demonstrated an ability to reduce hospitalizations and is currently limited to those patients who have separate indications for an implantable device. Biomarker levels have shown variable results in the ability to reduce hospitalizations and remain without definitive proof supporting their utilization. Remote hemodynamic monitoring has shown the strongest ability to reduce heart failure readmissions and is currently approved for this purpose. However, remote hemodynamic monitoring requires an invasive procedure and may not be cost-effective. All currently available strategies to reduce hospitalizations with remote monitoring have drawbacks and challenges. Remote hemodynamic monitoring is currently the most efficacious based on data, but is not without its own imperfections.

Developments in clinical trials: a Pharma Matters report.

PubMed

Arjona, A; Nuskey, B; Rabasseda, X; Arias, E

2014-08-01

As the pharmaceutical industry strives to meet the ever-increasing complexity of drug development, new technology in clinical trials has become a beacon of hope. With big data comes the promise of accelerated patient recruitment, real-time monitoring of clinical trials, bioinformatics empowerment of quicker phase progression, and the overwhelming benefits of precision medicine for select trials. Risk-based monitoring stands to benefit as well. With a strengthening focus on centralized data by the FDA and industry's transformative initiative, TransCelerate, a new era in trial risk mitigation has begun. The traditional method of intensive on-site monitoring is becoming a thing of the past as statistical, real-time analysis of site and trial-wide data provides the means to monitor with greater efficiency and effectiveness from afar. However, when it comes to big data, there are challenges that lie ahead. Patient privacy, commercial investment protection, technology woes and data variability are all limitations to be met with considerable thought. At the Annual Meeting of the American Academy of Dermatology this year, clinical trials on psoriasis, atopic dermatitis and other skin diseases were discussed in detail. This review of clinical research reports on novel therapies for psoriasis and atopic dermatitis reveals the impact of these diseases and the drug candidates that have been successful in phase II and III studies. Data-focused highlights of novel dermatological trials, as well as real-life big data approaches and an insight on the new methodology of risk-based monitoring, are all discussed in this edition of Developments in Clinical Trials. Copyright 2014 Prous Science, S.A.U. or its licensors. All rights reserved.

Realtime Multichannel System for Beat to Beat QT Interval Variability

NASA Technical Reports Server (NTRS)

Starc, Vito; Schlegel, Todd T.

2006-01-01

The measurement of beat-to-beat QT interval variability (QTV) shows clinical promise for identifying several types of cardiac pathology. However, until now, there has been no device capable of displaying, in real time on a beattobeat basis, changes in QTV in all 12 conventional leads in a continuously monitored patient. While several software programs have been designed to analyze QTV, heretofore, such programs have all involved only a few channels (at most) and/or have required laborious user interaction or offline calculations and postprocessing, limiting their clinical utility. This paper describes a PC-based ECG software program that in real time, acquires, analyzes and displays QTV and also PQ interval variability (PQV) in each of the eight independent channels that constitute the 12lead conventional ECG. The system also processes certain related signals that are derived from singular value decomposition and that help to reduce the overall effects of noise on the realtime QTV and PQV results.

Use of Electrical Impedance Tomography to Monitor Regional Cerebral Edema during Clinical Dehydration Treatment

PubMed Central

Hu, Shi-Jie; Li, Xia; Xu, Can-Hua; Wang, Bing; Yang, Bin; Tang, Meng-Xing; Dong, Xiu-Zhen; Fei, Zhou; Shi, Xue-Tao

2014-01-01

Objective Variations of conductive fluid content in brain tissue (e.g. cerebral edema) change tissue impedance and can potentially be measured by Electrical Impedance Tomography (EIT), an emerging medical imaging technique. The objective of this work is to establish the feasibility of using EIT as an imaging tool for monitoring brain fluid content. Design a prospective study. Setting In this study EIT was used, for the first time, to monitor variations in cerebral fluid content in a clinical model with patients undergoing clinical dehydration treatment. The EIT system was developed in house and its imaging sensitivity and spatial resolution were evaluated on a saline-filled tank. Patients 23 patients with brain edema. Interventions The patients were continuously imaged by EIT for two hours after initiation of dehydration treatment using 0.5 g/kg intravenous infusion of mannitol for 20 minutes. Measurement and Main Results Overall impedance across the brain increased significantly before and after mannitol dehydration treatment (p = 0.0027). Of the all 23 patients, 14 showed high-level impedance increase and maintained this around 4 hours after the dehydration treatment whereas the other 9 also showed great impedance gain during the treatment but it gradually decreased after the treatment. Further analysis of the regions of interest in the EIT images revealed that diseased regions, identified on corresponding CT images, showed significantly less impedance changes than normal regions during the monitoring period, indicating variations in different patients' responses to such treatment. Conclusions EIT shows potential promise as an imaging tool for real-time and non-invasive monitoring of brain edema patients. PMID:25474474

Green light for liver function monitoring using indocyanine green? An overview of current clinical applications.

PubMed

Vos, J J; Wietasch, J K G; Absalom, A R; Hendriks, H G D; Scheeren, T W L

2014-12-01

The dye indocyanine green is familiar to anaesthetists, and has been studied for more than half a century for cardiovascular and hepatic function monitoring. It is still, however, not yet in routine clinical use in anaesthesia and critical care, at least in Europe. This review is intended to provide a critical analysis of the available evidence concerning the indications for clinical measurement of indocyanine green elimination as a diagnostic and prognostic tool in two areas: its role in peri-operative liver function monitoring during major hepatic resection and liver transplantation; and its role in critically ill patients on the intensive care unit, where it is used for prediction of mortality, and for assessment of the severity of acute liver failure or that of intra-abdominal hypertension. Although numerous studies have demonstrated that indocyanine green elimination measurements in these patient populations can provide diagnostic or prognostic information to the clinician, 'hard' evidence - i.e. high-quality prospective randomised controlled trials - is lacking, and therefore it is not yet time to give a green light for use of indocyanine green in routine clinical practice. © 2014 The Association of Anaesthetists of Great Britain and Ireland.

Real-time monitoring of smallholder farmer responses to intra-seasonal climate variability in central Kenya

NASA Astrophysics Data System (ADS)

Krell, N.; Evans, T. P.; Estes, L. D.; Caylor, K. K.

2017-12-01

While international metrics of food security and water availability are generated as spatial averages at the regional to national levels, climate variability impacts are differentially felt at the household level. This project investigated scales of variability of climate impacts on smallholder farmers using social and environmental data in central Kenya. Using sub-daily real-time environmental measurements to monitor smallholder agriculture, we investigated how changes in seasonal precipitation affected food security around Laikipia county from September 2015 to present. We also conducted SMS-based surveys of over 700 farmers to understand farmers' decision-making within the growing season. Our results highlight field-scale heterogeneity in biophysical and social factors governing crop yields using locally sensed real-time environmental data and weekly farmer-reported information about planting, harvesting, irrigation, and crop yields. Our preliminary results show relationships between changes in seasonal precipitation, NDVI, and soil moisture related to crop yields and decision-making at several scales. These datasets present a unique opportunity to collect highly spatially and temporally resolved information from data-poor regions at the household level.

Clinical predictors of risk for atrial fibrillation: implications for diagnosis and monitoring.

PubMed

Brunner, Kyle J; Bunch, T Jared; Mullin, Christopher M; May, Heidi T; Bair, Tami L; Elliot, David W; Anderson, Jeffrey L; Mahapatra, Srijoy

2014-11-01

To create a risk score using clinical factors to determine whom to screen and monitor for atrial fibrillation (AF). The AF risk score was developed based on the summed odds ratios (ORs) for AF development of 7 accepted clinical risk factors. The AF risk score is intended to assess the risk of AF similar to how the CHA2DS2-VASc score assesses stroke risk. Seven validated risk factors for AF were used to develop the AF risk score: age, coronary artery disease, diabetes mellitus, sex, heart failure, hypertension, and valvular disease. The AF risk score was tested within a random population sample of the Intermountain Healthcare outpatient database. Outcomes were stratified by AF risk score for OR and Kaplan-Meier analysis. A total of 100,000 patient records with an index follow-up from January 1, 2002, through December 31, 2007, were selected and followed up for the development of AF through the time of this analysis, May 13, 2013, through September 6, 2013. Mean ± SD follow-up time was 3106±819 days. The ORs of subsequent AF diagnosis of patients with AF risk scores of 1, 2, 3, 4, and 5 or higher were 3.05, 12.9, 22.8, 34.0, and 48.0, respectively. The area under the curve statistic for the AF risk score was 0.812 (95% CI, 0.805-0.820). We developed a simple AF risk score made up of common clinical factors that may be useful to possibly select patients for long-term monitoring for AF detection. Copyright © 2014 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

Monitoring Crop Yield in USA Using a Satellite-Based Climate-Variability Impact Index

NASA Technical Reports Server (NTRS)

Zhang, Ping; Anderson, Bruce; Tan, Bin; Barlow, Mathew; Myneni, Ranga

2011-01-01

A quantitative index is applied to monitor crop growth and predict agricultural yield in continental USA. The Climate-Variability Impact Index (CVII), defined as the monthly contribution to overall anomalies in growth during a given year, is derived from 1-km MODIS Leaf Area Index. The growing-season integrated CVII can provide an estimate of the fractional change in overall growth during a given year. In turn these estimates can provide fine-scale and aggregated information on yield for various crops. Trained from historical records of crop production, a statistical model is used to produce crop yield during the growing season based upon the strong positive relationship between crop yield and the CVII. By examining the model prediction as a function of time, it is possible to determine when the in-season predictive capability plateaus and which months provide the greatest predictive capacity.

Electronic monitoring in bipolar disorder.

PubMed

Faurholt-Jepsen, Maria

2018-03-01

Major reasons for the insufficient effects of current treatment options in bipolar disorder include delayed intervention for prodromal depressive and manic symptoms and decreased adherence to psychopharmacological treatment. The reliance on subjective information and clinical evaluations when diagnosing and assessing the severity of depressive and manic symptoms calls for less biased and more objective markers. By using electronic devices, fine-grained data on complex psychopathological aspects of bipolar disorder can be evaluated unobtrusively over the long term. Moreover, electronic data could possibly represent candidate markers of diagnosis and illness activity in bipolar disorder and allow for early and individualized intervention for prodromal symptoms outside clinical settings. 
The present dissertation concerns the use of electronic monitoring as a marker and treatment intervention in bipolar disorder and investigated the scientific literature and body of evidence within the area, which includes ten original study reports and two systematic reviews, one of which included a meta-analysis, conducted by the author of the dissertation. 
Taken together, the literature presented in this dissertation illustrates that 1) smartphone-based electronic self-monitoring of mood seems to reflect clinically assessed depressive and manic symptoms and enables the long-term characterization of mood

instability in bipolar disorder; 2) preliminary results suggest that smartphone-based automatically generated data (e.g. the number of text messages sent/day; the number of incoming and outgoing calls/day; the number of changes in cell tower IDs/day; and voice features) seem to reflect clinically assessed depressive and manic symptoms in bipolar disorder; 3) smartphone-based electronic self-monitoring had no effects on the severity of depressive and manic symptoms in bipolar disorder, according to a randomized controlled trial; and 4) electronic monitoring of psychomotor

Method and apparatus for smart battery charging including a plurality of controllers each monitoring input variables

DOEpatents

Hammerstrom, Donald J.

2013-10-15

A method for managing the charging and discharging of batteries wherein at least one battery is connected to a battery charger, the battery charger is connected to a power supply. A plurality of controllers in communication with one and another are provided, each of the controllers monitoring a subset of input variables. A set of charging constraints may then generated for each controller as a function of the subset of input variables. A set of objectives for each controller may also be generated. A preferred charge rate for each controller is generated as a function of either the set of objectives, the charging constraints, or both, using an algorithm that accounts for each of the preferred charge rates for each of the controllers and/or that does not violate any of the charging constraints. A current flow between the battery and the battery charger is then provided at the actual charge rate.

On the temporal and spatial variability of near-surface soil moisture for the identification of representative in situ soil moisture monitoring stations

USDA-ARS?s Scientific Manuscript database

The high spatio-temporal variability of soil moisture complicates the validation of remotely sensed soil moisture products using in-situ monitoring stations. Therefore, a standard methodology for selecting the most repre- sentative stations for the purpose of validating satellites and land surface ...

[Blood pressure variability: clinical interest or simple curiosity?].

PubMed

Ciaroni, Stefano

2007-03-14

Blood pressure variability is a physiological phenomenon influenced by many internal and external factors. This variability could be also influenced by pathological conditions such as arterial hypertension. Two forms must be mainly distinguished: the blood pressure variability at long and short-term. The latter could only be studied by continuous recordings. In this article will be analysed the interest of measuring blood pressure variability, its cardiovascular prognosis and the therapeutic tools when it is increased.

The UK Infrared Telescope M33 monitoring project - IV. Variable red giant stars across the galactic disc

NASA Astrophysics Data System (ADS)

Javadi, Atefeh; Saberi, Maryam; van Loon, Jacco Th.; Khosroshahi, Habib; Golabatooni, Najmeh; Mirtorabi, Mohammad Taghi

2015-03-01

We have conducted a near-infrared monitoring campaign at the UK InfraRed Telescope, of the Local Group spiral galaxy M33 (Triangulum). The main aim was to identify stars in the very final stage of their evolution, and for which the luminosity is more directly related to the birth mass than the more numerous less-evolved giant stars that continue to increase in luminosity. In this fourth paper of the series, we present a search for variable red giant stars in an almost square degree region comprising most of the galaxy's disc, carried out with the WFCAM (Wide Field CAMera) instrument in the K band. These data, taken during the period 2005-2007, were complemented by J- and H-band images. Photometry was obtained for 403 734 stars in this region; of these, 4643 stars were found to be variable, most of which are asymptotic giant branch (AGB) stars. The variable stars are concentrated towards the centre of M33, more so than low-mass, less-evolved red giants. Our data were matched to optical catalogues of variable stars and carbon stars and to mid-infrared photometry from the Spitzer Space Telescope. Most dusty AGB stars had not been previously identified in optical variability surveys, and our survey is also more complete for these types of stars than the Spitzer survey. The photometric catalogue is made publicly available at the Centre de Données astronomiques de Strasbourg.

Identifying emotional intelligence skills of Turkish clinical nurses according to sociodemographic and professional variables.

PubMed

Kahraman, Nilgün; Hiçdurmaz, Duygu

2016-04-01

This study aimed to identify the emotional intelligence skills of Turkish clinical nurses according to sociodemographic and professional variables. Emotional intelligence is "the ability of a person to comprehend self-emotions, to show empathy towards the feelings of others, and to control self-emotions in a way that enriches life." Nurses with a higher emotional intelligence level offer more efficient and professional care, and they accomplish more in their social and professional lives. We designed a descriptive cross-sectional study. The Introductory Information Form and the Bar-On emotional intelligence Inventory were used to collect data between 20th June and 20th August 2012. The study was conducted with 312 nurses from 37 hospitals located within the borders of the metropolitan municipality in Ankara. There were no significant differences between emotional intelligence scores of the nurses according to demographic variables such as age, gender, marital status, having children. Thus, sociodemographic factors did not appear to be key factors, but some professional variables did. Higher total emotional intelligence scores were observed in those who had 10 years or longer experience, who found oneself successful in professional life, who stated that emotional intelligence is an improvable skill and who previously received self-improvement training. Interpersonal skills were higher in those with a graduate degree and in nurses working in polyclinics and paediatric units. These findings indicate which groups require improvement in emotional intelligence skills and which skills need improvement. Additionally, these results provide knowledge and create awareness about emotional intelligence skills of nurses and the distribution of these skills according to sociodemographic and professional variables. Implementation of emotional intelligence improvement programmes targeting the determined clinical nursing groups by nursing administrations can help the increase in

PlaIMoS: A Remote Mobile Healthcare Platform to Monitor Cardiovascular and Respiratory Variables

PubMed Central

Miramontes, Ramses; Aquino, Raúl; Flores, Arturo; Rodríguez, Guillermo; Anguiano, Rafael; Ríos, Arturo; Edwards, Arthur

2017-01-01

The number of elderly and chronically ill patients has grown significantly over the past few decades as life expectancy has increased worldwide, leading to increased demands on the health care system and significantly taxing traditional health care practices. Consequently, there is an urgent need to use technology to innovate and more constantly and intensely monitor, report and analyze critical patient physiological parameters beyond conventional clinical settings in a more efficient and cost effective manner. This paper presents a technological platform called PlaIMoS which consists of wearable sensors, a fixed measurement station, a network infrastructure that employs IEEE 802.15.4 and IEEE 802.11 to transmit data with security mechanisms, a server to analyze all information collected and apps for iOS, Android and Windows 10 mobile operating systems to provide real-time measurements. The developed architecture, designed primarily to record and report electrocardiogram and heart rate data, also monitors parameters associated with chronic respiratory illnesses, including patient blood oxygen saturation and respiration rate, body temperature, fall detection and galvanic resistance. PMID:28106832

PlaIMoS: A Remote Mobile Healthcare Platform to Monitor Cardiovascular and Respiratory Variables.

PubMed

Miramontes, Ramses; Aquino, Raúl; Flores, Arturo; Rodríguez, Guillermo; Anguiano, Rafael; Ríos, Arturo; Edwards, Arthur

2017-01-19

The number of elderly and chronically ill patients has grown significantly over the past few decades as life expectancy has increased worldwide, leading to increased demands on the health care system and significantly taxing traditional health care practices. Consequently, there is an urgent need to use technology to innovate and more constantly and intensely monitor, report and analyze critical patient physiological parameters beyond conventional clinical settings in a more efficient and cost effective manner. This paper presents a technological platform called PlaIMoS which consists of wearable sensors, a fixed measurement station, a network infrastructure that employs IEEE 802.15.4 and IEEE 802.11 to transmit data with security mechanisms, a server to analyze all information collected and apps for iOS, Android and Windows 10 mobile operating systems to provide real-time measurements. The developed architecture, designed primarily to record and report electrocardiogram and heart rate data, also monitors parameters associated with chronic respiratory illnesses, including patient blood oxygen saturation and respiration rate, body temperature, fall detection and galvanic resistance.

Evaluation of a continual compliance monitoring program for dapsone in an outpatient Hansen's disease clinic.

PubMed

Fischer, J H; West, D P; Worobec, S M

1986-12-01

Guidelines for the assessment of patient compliance to dapsone were developed and evaluated. The urinary dapsone-to-creatinine (D/C) ratio following standardization by dose, ideal body weight, and time since last dose was used for assessment of compliance. Compliance standards were established in 12 patients of known compliance and confirmed prospectively in nine inpatients on 14 occasions. Compliance increased significantly among outpatients (N = 30) attending the University of Illinois Hansen's Disease Clinic from 47% at base line to 73% at 6 months and 80% at 18 months after establishing the monitoring program. In a subgroup of 18 patients, a similar increase in compliance was observed from 50% to 80%. A good therapeutic response was seen in the subgroup patients who were compliant. A poor therapeutic response was seen in the consistently noncompliant patients. These results demonstrate that use of a continual compliance monitoring program can improve patient drug compliance in an outpatient Hansen's disease clinic.

Atmospheric Parameter Climatologies from AIRS: Monitoring Short-, and Longer-Term Climate Variabilities and 'Trends'

NASA Technical Reports Server (NTRS)

Molnar, Gyula; Susskind, Joel

2008-01-01

The AIRS instrument is currently the best space-based tool to simultaneously monitor the vertical distribution of key climatically important atmospheric parameters as well as surface properties, and has provided high quality data for more than 5 years. AIRS analysis results produced at the GODDARD/DAAC, based on Versions 4 & 5 of the AIRS retrieval algorithm, are currently available for public use. Here, first we present an assessment of interrelationships of anomalies (proxies of climate variability based on 5 full years, since Sept. 2002) of various climate parameters at different spatial scales. We also present AIRS-retrievals-based global, regional and 1x1 degree grid-scale "trend"-analyses of important atmospheric parameters for this 5-year period. Note that here "trend" simply means the linear fit to the anomaly (relative the mean seasonal cycle) time series of various parameters at the above-mentioned spatial scales, and we present these to illustrate the usefulness of continuing AIRS-based climate observations. Preliminary validation efforts, in terms of intercomparisons of interannual variabilities with other available satellite data analysis results, will also be addressed. For example, we show that the outgoing longwave radiation (OLR) interannual spatial variabilities from the available state-of-the-art CERES measurements and from the AIRS computations are in remarkably good agreement. Version 6 of the AIRS retrieval scheme (currently under development) promises to further improve bias agreements for the absolute values by implementing a more accurate radiative transfer model for the OLR computations and by improving surface emissivity retrievals.

Tools to minimize interlaboratory variability in vitellogenin gene expression monitoring programs

USGS Publications Warehouse

Jastrow, Aaron; Gordon, Denise A.; Auger, Kasie M.; Punska, Elizabeth C.; Arcaro, Kathleen F.; Keteles, Kristen; Winkelman, Dana L.; Lattier, David; Biales, Adam; Lazorchak, James M.

2017-01-01

The egg yolk precursor protein vitellogenin is widely used as a biomarker of estrogen exposure in male fish. However, standardized methodology is lacking and little is known regarding the reproducibility of results among laboratories using different equipment, reagents, protocols, and data analysis programs. To address this data gap we tested the reproducibility across laboratories to evaluate vitellogenin gene (vtg) expression and assessed the value of using a freely available software data analysis program. Samples collected from studies of male fathead minnows (Pimephales promelas) exposed to 17α-ethinylestradiol (EE2) and minnows exposed to processed wastewater effluent were evaluated for vtg expression in 4 laboratories. Our results indicate reasonable consistency among laboratories if the free software for expression analysis LinRegPCR is used, with 3 of 4 laboratories detecting vtg in fish exposed to 5 ng/L EE2 (n = 5). All 4 laboratories detected significantly increased vtg levels in 15 male fish exposed to wastewater effluent compared with 15 male fish held in a control stream. Finally, we were able to determine that the source of high interlaboratory variability from complementary deoxyribonucleic acid (cDNA) to quantitative polymerase chain reaction (qPCR) analyses was the expression analysis software unique to each real-time qPCR machine. We successfully eliminated the interlaboratory variability by reanalyzing raw fluorescence data with independent freeware, which yielded cycle thresholds and polymerase chain reaction (PCR) efficiencies that calculated results independently of proprietary software. Our results suggest that laboratories engaged in monitoring programs should validate their PCR protocols and analyze their gene expression data following the guidelines established in the present study for all gene expression biomarkers. 

Economic impact of clinical variability in preoperative testing for major outpatient surgery.

PubMed

Gil-Borrelli, Christian Carlo; Agustí, Salomé; Pla, Rosa; Díaz-Redondo, Alicia; Zaballos, Matilde

2016-05-01

With the purpose of decreasing the existing variability in the criteria of preoperative evaluation and facilitating the clinical decision-making process, our hospital has a protocol of preoperative tests to use with ASA I and ASA II patients. The aim of the study was to calculate the economic impact caused by clinicians' non-adherence to the protocol for the anaesthesiological evaluation of ASA 1 and ASA II patients. A retrospective study of costs with a random sample of 353 patients that were seen in the consultation for Anesthesiology over a period of one year. Aspects related to the costs, patient's profiles and specialties were analysed, according to the degree of fulfillment of the protocol. The lack of adherence to the the protocol was 70%. 130 chest X-rays and 218 ECG were performed without indication. This generated an excess costs of 34 € per patient. Taking into account the expenses of both tests and the attended population undergoing ambulatory surgery during the one-year period, an excess spending for the hospital of between 69.164 € and 83.312 € was estimated. Clinical variability should be reduced and the creation of synergies between the different departments should be enhanced in order to adjust the request for unnecessary complementary tests to decrease health care and to improve the quality of patient care. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Variable input observer for structural health monitoring of high-rate systems

NASA Astrophysics Data System (ADS)

Hong, Jonathan; Laflamme, Simon; Cao, Liang; Dodson, Jacob

2017-02-01

The development of high-rate structural health monitoring methods is intended to provide damage detection on timescales of 10 µs -10ms where speed of detection is critical to maintain structural integrity. Here, a novel Variable Input Observer (VIO) coupled with an adaptive observer is proposed as a potential solution for complex high-rate problems. The VIO is designed to adapt its input space based on real-time identification of the system's essential dynamics. By selecting appropriate time-delayed coordinates defined by both a time delay and an embedding dimension, the proper input space is chosen which allows more accurate estimations of the current state and a reduction of the convergence rate. The optimal time-delay is estimated based on mutual information, and the embedding dimension is based on false nearest neighbors. A simulation of the VIO is conducted on a two degree-of-freedom system with simulated damage. Results are compared with an adaptive Luenberger observer, a fixed time-delay observer, and a Kalman Filter. Under its preliminary design, the VIO converges significantly faster than the Luenberger and fixed observer. It performed similarly to the Kalman Filter in terms of convergence, but with greater accuracy.

Monitoring peripheral perfusion and microcirculation.

PubMed

Dubin, Arnaldo; Henriquez, Elizabeth; Hernández, Glenn

2018-06-01

Microcirculatory alterations play a major role in the pathogenesis of shock. Monitoring tissue perfusion might be a relevant goal for shock resuscitation. The goal of this review was to revise the evidence supporting the monitoring of peripheral perfusion and microcirculation as goals of resuscitation. For this purpose, we mainly focused on skin perfusion and sublingual microcirculation. Although there are controversies about the reproducibility of capillary refill time in monitoring peripheral perfusion, it is a sound physiological variable and suitable for the ICU settings. In addition, observational studies showed its strong ability to predict outcome. Moreover, a preliminary study suggested that it might be a valuable goal for resuscitation. These results should be confirmed by the ongoing ANDROMEDA-SHOCK randomized controlled trial. On the other hand, the monitoring of sublingual microcirculation might also provide relevant physiological and prognostic information. On the contrary, methodological drawbacks mainly related to video assessment hamper its clinical implementation at the present time. Measurements of peripheral perfusion might be useful as goal of resuscitation. The results of the ANDROMEDA-SHOCK will clarify the role of skin perfusion as a guide for the treatment of shock. In contrast, the assessment of sublingual microcirculation mainly remains as a research tool.

Validation of Heart Rate Monitor Polar RS800 for Heart Rate Variability Analysis During Exercise.

PubMed

Hernando, David; Garatachea, Nuria; Almeida, Rute; Casajús, Jose A; Bailón, Raquel

2018-03-01

Hernando, D, Garatachea, N, Almeida, R, Casajús, JA, and Bailón, R. Validation of heart rate monitor Polar RS800 for heart rate variability analysis during exercise. J Strength Cond Res 32(3): 716-725, 2018-Heart rate variability (HRV) analysis during exercise is an interesting noninvasive tool to measure the cardiovascular response to the stress of exercise. Wearable heart rate monitors are a comfortable option to measure interbeat (RR) intervals while doing physical activities. It is necessary to evaluate the agreement between HRV parameters derived from the RR series recorded by wearable devices and those derived from an electrocardiogram (ECG) during dynamic exercise of low to high intensity. Twenty-three male volunteers performed an exercise stress test on a cycle ergometer. Subjects wore a Polar RS800 device, whereas ECG was also recorded simultaneously to extract the reference RR intervals. A time-frequency spectral analysis was performed to extract the instantaneous mean heart rate (HRM), and the power of low-frequency (PLF) and high-frequency (PHF) components, the latter centered on the respiratory frequency. Analysis was done in intervals of different exercise intensity based on oxygen consumption. Linear correlation, reliability, and agreement were computed in each interval. The agreement between the RR series obtained from the Polar device and from the ECG is high throughout the whole test although the shorter the RR is, the more differences there are. Both methods are interchangeable when analyzing HRV at rest. At high exercise intensity, HRM and PLF still presented a high correlation (ρ > 0.8) and excellent reliability and agreement indices (above 0.9). However, the PHF measurements from the Polar showed reliability and agreement coefficients around 0.5 or lower when the level of the exercise increases (for levels of O2 above 60%).

Beat-to-beat variability of cardiac action potential duration: underlying mechanism and clinical implications.

PubMed

Nánási, Péter P; Magyar, János; Varró, András; Ördög, Balázs

2017-10-01

Beat-to-beat variability of cardiac action potential duration (short-term variability, SV) is a common feature of various cardiac preparations, including the human heart. Although it is believed to be one of the best arrhythmia predictors, the underlying mechanisms are not fully understood at present. The magnitude of SV is basically determined by the intensity of cell-to-cell coupling in multicellular preparations and by the duration of the action potential (APD). To compensate for the APD-dependent nature of SV, the concept of relative SV (RSV) has been introduced by normalizing the changes of SV to the concomitant changes in APD. RSV is reduced by I Ca , I Kr , and I Ks while increased by I Na , suggesting that ion currents involved in the negative feedback regulation of APD tend to keep RSV at a low level. RSV is also influenced by intracellular calcium concentration and tissue redox potential. The clinical implications of APD variability is discussed in detail.

Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation.

PubMed

Dario, Claudio; Delise, Pietro; Gubian, Lorenzo; Saccavini, Claudio; Brandolino, Glauco; Mancin, Silvia

2016-01-13

Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3-12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a "real world" context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM) and 0.37 (ICD) real clinical events per

Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study.

PubMed

De Simone, Antonio; Leoni, Loira; Luzi, Mario; Amellone, Claudia; Stabile, Giuseppe; La Rocca, Vincenzo; Capucci, Alessandro; D'onofrio, Antonio; Ammendola, Ernesto; Accardi, Francesco; Valsecchi, Sergio; Buja, Gianfranco

2015-08-01

Internet-based remote interrogation systems have been shown to reduce emergency department and in-office visits in patients with implantable cardioverter defibrillators (ICDs), resulting in increased efficiency for healthcare providers. Nonetheless, studies sized to demonstrate the impact of remote monitoring on patients' outcome have been lacking. The EFFECT study was a multicentre clinical trial aimed at measuring and comparing the outcome of ICD patients conventionally followed-up by means of in-clinic visits (Standard arm) or by remote monitoring (Remote arm) in the clinical practice of 25 Italian centres. From 2011 to 2013, 987 consecutive patients were enrolled and followed up for at least 12 months. The primary endpoint was the rate of death and cardiovascular hospitalizations. Remote monitoring was adopted by 499 patients. Patients in the Standard and Remote arms did not differ significantly in terms of baseline clinical characteristics, except for a more frequent use of ICD with cardiac resynchronization therapy (CRT-D) in the Remote arm (48 vs. 36%, P < 0.001). One-year rates of the primary combined endpoint were 0.27 events/year for patients in the Standard arm and were 0.15 events/year for those in the Remote arm (incident rate ratio, 0.55; 95% CI, 0.41-0.73; P < 0.001). The endpoint rates in the Standard and Remote arms were 0.27 and 0.08 events/year, respectively, among CRT-D recipients (P < 0.001), and 0.28 vs. 0.21 among ICD patients (P = 0.094). The rates of in-office visits were 1.9 per year in the Standard arm and 1.7 per year in the Remote arm. Compared with the standard follow-up through in-office visits, remote monitoring is associated with reduced death and cardiovascular hospitalizations in patients with ICD in clinical practice. URL: http://clinicaltrials.gov/ Identifier: NCT01723865. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Establishing a reliable multiple reaction monitoring-based method for the quantification of obesity-associated comorbidities in serum and adipose tissue requires intensive clinical validation.

PubMed

Oberbach, Andreas; Schlichting, Nadine; Neuhaus, Jochen; Kullnick, Yvonne; Lehmann, Stefanie; Heinrich, Marco; Dietrich, Arne; Mohr, Friedrich Wilhelm; von Bergen, Martin; Baumann, Sven

2014-12-05

Multiple reaction monitoring (MRM)-based mass spectrometric quantification of peptides and their corresponding proteins has been successfully applied for biomarker validation in serum. The option of multiplexing offers the chance to analyze various proteins in parallel, which is especially important in obesity research. Here, biomarkers that reflect multiple comorbidities and allow monitoring of therapy outcomes are required. Besides the suitability of established MRM assays for serum protein quantification, it is also feasible for analysis of tissues secreting the markers of interest. Surprisingly, studies comparing MRM data sets with established methods are rare, and therefore the biological and clinical value of most analytes remains questionable. A MRM method using nano-UPLC-MS/MS for the quantification of obesity related surrogate markers for several comorbidities in serum, plasma, visceral and subcutaneous adipose tissue was established. Proteotypic peptides for complement C3, adiponectin, angiotensinogen, and plasma retinol binding protein (RBP4) were quantified using isotopic dilution analysis and compared to the standard ELISA method. MRM method variabilities were mainly below 10%. The comparison with other MS-based approaches showed a good correlation. However, large differences in absolute quantification for complement C3 and adiponectin were obtained compared to ELISA, while less marked differences were observed for angiotensinogen and RBP4. The verification of MRM in obesity was performed to discriminate first lean and obese phenotype and second to monitor excessive weight loss after gastric bypass surgery in a seven-month follow-up. The presented MRM assay was able to discriminate obese phenotype from lean and monitor weight loss related changes of surrogate markers. However, inclusion of additional biomarkers was necessary to interpret the MRM data on obesity phenotype properly. In summary, the development of disease-related MRMs should include a

Intra-Gene DNA Methylation Variability Is a Clinically Independent Prognostic Marker in Women's Cancers.

PubMed

Bartlett, Thomas E; Jones, Allison; Goode, Ellen L; Fridley, Brooke L; Cunningham, Julie M; Berns, Els M J J; Wik, Elisabeth; Salvesen, Helga B; Davidson, Ben; Trope, Claes G; Lambrechts, Sandrina; Vergote, Ignace; Widschwendter, Martin

2015-01-01

We introduce a novel per-gene measure of intra-gene DNA methylation variability (IGV) based on the Illumina Infinium HumanMethylation450 platform, which is prognostic independently of well-known predictors of clinical outcome. Using IGV, we derive a robust gene-panel prognostic signature for ovarian cancer (OC, n = 221), which validates in two independent data sets from Mayo Clinic (n = 198) and TCGA (n = 358), with significance of p = 0.004 in both sets. The OC prognostic signature gene-panel is comprised of four gene groups, which represent distinct biological processes. We show the IGV measurements of these gene groups are most likely a reflection of a mixture of intra-tumour heterogeneity and transcription factor (TF) binding/activity. IGV can be used to predict clinical outcome in patients individually, providing a surrogate read-out of hard-to-measure disease processes.

Variability of the human heart rate as a diagnostic instrument obtained by mean of a wireless monitor

NASA Astrophysics Data System (ADS)

Barajas Mauricio, Sánchez; Hernández González, Martha Alicia; Figueroa Vega, Nicte; Malacara Hernández, Juan Manuel; Fraga Teodoro, Córdova

2014-11-01

Introduction: Heart rate variability (HRV) is the cyclic measurement of RR intervals between normal beats. Aim: To determine the VFC via a wireless Polar monitor. Material and methods: 100 symptomatic menopausal women were studied for measurements of HRV were I post a Polar RS400 Watch four hrs. Results: Obtained through the fast Fourier transform, the frequency domain HRV low frequency (LF) 0.04-0.15 Hz, high frequency (HF) 0.15-0.4Hz and the ratio LF / HF. Conclusion: obtaining HRV is important for cardiovascular autonomic assessment in menopausal women.

Variability of word discrimination scores in clinical practice and consequences on their sensitivity to hearing loss.

PubMed

Moulin, Annie; Bernard, André; Tordella, Laurent; Vergne, Judith; Gisbert, Annie; Martin, Christian; Richard, Céline

2017-05-01

Speech perception scores are widely used to assess patient's functional hearing, yet most linguistic material used in these audiometric tests dates to before the availability of large computerized linguistic databases. In an ENT clinic population of 120 patients with median hearing loss of 43-dB HL, we quantified the variability and the sensitivity of speech perception scores to hearing loss, measured using disyllabic word lists, as a function of both the number of ten-word lists and type of scoring used (word, syllables or phonemes). The mean word recognition scores varied significantly across lists from 54 to 68%. The median of the variability of the word recognition score ranged from 30% for one ten-word list down to 20% for three ten-word lists. Syllabic and phonemic scores showed much less variability with standard deviations decreasing by 1.15 with the use of syllabic scores and by 1.45 with phonemic scores. The sensitivity of each list to hearing loss and distortions varied significantly. There was an increase in the minimum effect size that could be seen for syllabic scores compared to word scores, with no significant further improvement with phonemic scores. The use of at least two ten-word lists, quoted in syllables rather than in whole words, contributed to a large decrease in variability and an increase in sensitivity to hearing loss. However, those results emphasize the need of using updated linguistic material for clinical speech score assessments.

Large-Scale Variability of Inpatient Tacrolimus Therapeutic Drug Monitoring at an Academic Transplant Center: a Retrospective Study.

PubMed

Strohbehn, Garth W; Pan, Warren W; Petrilli, Christopher M; Heidemann, Lauren; Larson, Sophia; Aaronson, Keith D; Johnson, Matt; Ellies, Tammy; Heung, Michael

2018-04-30

Inpatient tacrolimus therapeutic drug monitoring (TDM) lacks standardized guidelines. In this study, the authors analyzed variability in the pre-analytical phase of the inpatient tacrolimus TDM process at their institution. Patients receiving tacrolimus (twice-daily formulation) and tacrolimus laboratory analysis were included in the study. Times of tacrolimus administration and laboratory study collection were extracted and time distribution plots for each step in the inpatient TDM process were generated. Trough levels were drawn appropriately in 25.9% of the cases. Timing between doses was consistent, with 91.9% of the following dose administrations occurring 12 +/- 2 hours after the previous dose. Only 38.1% of the drug administrations occurred within one hour of laboratory study collection. Tacrolimus-related patient safety events were reported at a rate of 1.9 events per month while incorrect timing of TDM sample collection occurred approximately 200 times per month. Root cause analysis identified a TDM process marked by a lack of communication and coordination of drug administration and TDM sample collection. Extrapolating findings nationwide, we estimate $22 million in laboratory costs wasted annually. Based on this large single-center study, the authors concluded that the inpatient TDM process is prone to timing errors, thus is financially wasteful, and at its worst harmful to patients due to clinical decisions being made on the basis of unreliable data. Further work is needed on systems solutions to better align the laboratory study collection and drug administration processes.

Personality-based subtypes of anorexia nervosa: examining validity and utility using baseline clinical variables and ecological momentary assessment.

PubMed

Lavender, Jason M; Wonderlich, Stephen A; Crosby, Ross D; Engel, Scott G; Mitchell, James E; Crow, Scott J; Peterson, Carol B; Le Grange, Daniel

2013-08-01

This study sought to empirically derive and validate clinically relevant personality-based subtypes of anorexia nervosa (AN). Women (N = 116) with full or subthreshold AN completed baseline measures of personality, clinical variables, and eating disorder (ED) symptoms, followed by two weeks of ecological momentary assessment (EMA). A latent profile analysis was conducted to identify personality subtypes, which were compared on baseline clinical variables and EMA variables. The best-fitting model supported three subtypes: underregulated, overregulated, and low psychopathology. The underregulated subtype (characterized by high Stimulus Seeking, Self-Harm, and Oppositionality) displayed greater baseline ED symptoms, as well as lower positive affect and greater negative affect, self-discrepancy, and binge eating in the natural environment. The overregulated subtype (characterized by high Compulsivity and low Stimulus Seeking) was more likely to have a lifetime obsessive-compulsive disorder diagnosis and exhibited greater perfectionism; levels of negative affect, positive affect, and self-discrepancy in this group were intermediate between the other subtypes. The low psychopathology subtype (characterized by normative personality) displayed the lowest levels of baseline ED symptoms, co-occurring disorders, and ED behaviors measured via EMA. Findings support the validity of these personality-based subtypes, suggesting the potential utility of addressing within-diagnosis heterogeneity in the treatment of AN. Copyright © 2013 Elsevier Ltd. All rights reserved.

A Computer-Aided Analysis Method of SPECT Brain Images for Quantitative Treatment Monitoring: Performance Evaluations and Clinical Applications.

PubMed

Zheng, Xiujuan; Wei, Wentao; Huang, Qiu; Song, Shaoli; Wan, Jieqing; Huang, Gang

2017-01-01

The objective and quantitative analysis of longitudinal single photon emission computed tomography (SPECT) images are significant for the treatment monitoring of brain disorders. Therefore, a computer aided analysis (CAA) method is introduced to extract a change-rate map (CRM) as a parametric image for quantifying the changes of regional cerebral blood flow (rCBF) in longitudinal SPECT brain images. The performances of the CAA-CRM approach in treatment monitoring are evaluated by the computer simulations and clinical applications. The results of computer simulations show that the derived CRMs have high similarities with their ground truths when the lesion size is larger than system spatial resolution and the change rate is higher than 20%. In clinical applications, the CAA-CRM approach is used to assess the treatment of 50 patients with brain ischemia. The results demonstrate that CAA-CRM approach has a 93.4% accuracy of recovered region's localization. Moreover, the quantitative indexes of recovered regions derived from CRM are all significantly different among the groups and highly correlated with the experienced clinical diagnosis. In conclusion, the proposed CAA-CRM approach provides a convenient solution to generate a parametric image and derive the quantitative indexes from the longitudinal SPECT brain images for treatment monitoring.

An Interoperable System toward Cardiac Risk Stratification from ECG Monitoring

PubMed Central

Mora-Jiménez, Inmaculada; Ramos-López, Javier; Quintanilla Fernández, Teresa; García-García, Antonio; Díez-Mazuela, Daniel; García-Alberola, Arcadi

2018-01-01

Many indices have been proposed for cardiovascular risk stratification from electrocardiogram signal processing, still with limited use in clinical practice. We created a system integrating the clinical definition of cardiac risk subdomains from ECGs and the use of diverse signal processing techniques. Three subdomains were defined from the joint analysis of the technical and clinical viewpoints. One subdomain was devoted to demographic and clinical data. The other two subdomains were intended to obtain widely defined risk indices from ECG monitoring: a simple-domain (heart rate turbulence (HRT)), and a complex-domain (heart rate variability (HRV)). Data provided by the three subdomains allowed for the generation of alerts with different intensity and nature, as well as for the grouping and scrutinization of patients according to the established processing and risk-thresholding criteria. The implemented system was tested by connecting data from real-world in-hospital electronic health records and ECG monitoring by considering standards for syntactic (HL7 messages) and semantic interoperability (archetypes based on CEN/ISO EN13606 and SNOMED-CT). The system was able to provide risk indices and to generate alerts in the health records to support decision-making. Overall, the system allows for the agile interaction of research and clinical practice in the Holter-ECG-based cardiac risk domain. PMID:29494497

A new definition of pharmaceutical quality: assembly of a risk simulation platform to investigate the impact of manufacturing/product variability on clinical performance.

PubMed

Short, Steven M; Cogdill, Robert P; D'Amico, Frank; Drennen, James K; Anderson, Carl A

2010-12-01

The absence of a unanimous, industry-specific definition of quality is, to a certain degree, impeding the progress of ongoing efforts to "modernize" the pharmaceutical industry. This work was predicated on requests by Dr. Woodcock (FDA) to re-define pharmaceutical quality in terms of risk by linking production characteristics to clinical attributes. A risk simulation platform that integrates population statistics, drug delivery system characteristics, dosing guidelines, patient compliance estimates, production metrics, and pharmacokinetic, pharmacodynamic, and in vitro-in vivo correlation models to investigate the impact of manufacturing variability on clinical performance of a model extended-release theophylline solid oral dosage system was developed. Manufacturing was characterized by inter- and intra-batch content uniformity and dissolution variability metrics, while clinical performance was described by a probabilistic pharmacodynamic model that expressed the probability of inefficacy and toxicity as a function of plasma concentrations. Least-squares regression revealed that both patient compliance variables, percent of doses taken and dosing time variability, significantly impacted efficacy and toxicity. Additionally, intra-batch content uniformity variability elicited a significant change in risk scores for the two adverse events and, therefore, was identified as a critical quality attribute. The proposed methodology demonstrates that pharmaceutical quality can be recast to explicitly reflect clinical performance. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association

Verification of monitor unit calculations for non-IMRT clinical radiotherapy: report of AAPM Task Group 114.

PubMed

Stern, Robin L; Heaton, Robert; Fraser, Martin W; Goddu, S Murty; Kirby, Thomas H; Lam, Kwok Leung; Molineu, Andrea; Zhu, Timothy C

2011-01-01

The requirement of an independent verification of the monitor units (MU) or time calculated to deliver the prescribed dose to a patient has been a mainstay of radiation oncology quality assurance. The need for and value of such a verification was obvious when calculations were performed by hand using look-up tables, and the verification was achieved by a second person independently repeating the calculation. However, in a modern clinic using CT/MR/PET simulation, computerized 3D treatment planning, heterogeneity corrections, and complex calculation algorithms such as convolution/superposition and Monte Carlo, the purpose of and methodology for the MU verification have come into question. In addition, since the verification is often performed using a simpler geometrical model and calculation algorithm than the primary calculation, exact or almost exact agreement between the two can no longer be expected. Guidelines are needed to help the physicist set clinically reasonable action levels for agreement. This report addresses the following charges of the task group: (1) To re-evaluate the purpose and methods of the "independent second check" for monitor unit calculations for non-IMRT radiation treatment in light of the complexities of modern-day treatment planning. (2) To present recommendations on how to perform verification of monitor unit calculations in a modern clinic. (3) To provide recommendations on establishing action levels for agreement between primary calculations and verification, and to provide guidance in addressing discrepancies outside the action levels. These recommendations are to be used as guidelines only and shall not be interpreted as requirements.

The variable clinical presentation of tuberculosis otitis media and the importance of early detection.

PubMed

Abes, Generoso T; Abes, Franco Louie L B; Jamir, Joselito C

2011-06-01

Tuberculosis (TB) is a rare cause of otitis media. This study aims to increase awareness on the clinical presentation of TB otitis media and illustrate how early detection affects treatment outcome. Chart review of 12 patients (13 ears) from a tertiary hospital in Manila, Philippines, seen from 2004 to 2009. Clinical predictors of the disease were summarized. Clinical, radiologic, and audiometric outcomes after treatment were compared between treatment groups. The 5 otoscopic presentations were multiple perforations, single perforation with refractory otorrhea and exuberant granulation tissue formation, single perforation with minimal otorrhea and no granulation tissue formation, intact tympanic membrane with middle ear effusion, and intact tympanic membrane with tumorlike tissue in the middle ear. Clinical predictors of the disease were history of pulmonary TB, work-related contamination of the infection, positive purified protein derivative test, positive chest radiographic finding and intraoperative granulation tissue with cheesy material, and temporal bone computed tomographic scan findings. Patients who had no middle ear surgery showed significantly better clinical, radiologic, and audiometric outcomes than those who were diagnosed late and had more complicated surgical procedure. The clinical presentation of TB otitis media is variable. Early detection of the early forms entail less surgical intervention and favors better treatment results.

Effelsberg Monitoring of a Sample of RadioAstron Blazars: Analysis of Intra-Day Variability

NASA Astrophysics Data System (ADS)

Liu, Jun; Bignall, Hayley; Krichbaum, Thomas; Liu, Xiang; Kraus, Alex; Kovalev, Yuri; Sokolovsky, Kirill; Angelakis, Emmanouil; Zensus, J.

2018-04-01

We present the first results of an ongoing intra-day variability (IDV) flux density monitoring program of 107 blazars, which were selected from a sample of RadioAstron space very long baseline interferometry (VLBI) targets. The~IDV observations were performed with the Effelsberg 100-m radio telescope at 4.8\\,GHz, focusing on the statistical properties of IDV in a relatively large sample of compact active galactic nuclei (AGN). We investigated the dependence of rapid ($<$3 day) variability on various source properties through a likelihood approach. We found that the IDV amplitude depends on flux density and that fainter sources vary by about a factor of 3 more than their brighter counterparts. We also found a significant difference in the variability amplitude between inverted- and flat-spectrum radio sources, with the former exhibiting stronger variations. $\\gamma$-ray loud sources were found to vary by up to a factor 4 more than $\\gamma$-ray quiet ones, with 4$\\sigma$ significance. However a galactic latitude dependence was barely observed, which suggests that it is predominantly the intrinsic properties (e.g., angular size, core-dominance) of the blazars that determine how they scintillate, rather than the directional dependence in the interstellar medium (ISM). We showed that the uncertainty in the VLBI brightness temperatures obtained from the space VLBI data of the RadioAstron satellite can be as high as $\\sim$70\\% due to the presence of the rapid flux density variations. Our statistical results support the view that IDV at centimeter wavelengths is predominantly caused by interstellar scintillation (ISS) of the emission from the most compact, core-dominant region in an AGN.

Logic Learning Machine and standard supervised methods for Hodgkin's lymphoma prognosis using gene expression data and clinical variables.

PubMed

Parodi, Stefano; Manneschi, Chiara; Verda, Damiano; Ferrari, Enrico; Muselli, Marco

2018-03-01

This study evaluates the performance of a set of machine learning techniques in predicting the prognosis of Hodgkin's lymphoma using clinical factors and gene expression data. Analysed samples from 130 Hodgkin's lymphoma patients included a small set of clinical variables and more than 54,000 gene features. Machine learning classifiers included three black-box algorithms ( k-nearest neighbour, Artificial Neural Network, and Support Vector Machine) and two methods based on intelligible rules (Decision Tree and the innovative Logic Learning Machine method). Support Vector Machine clearly outperformed any of the other methods. Among the two rule-based algorithms, Logic Learning Machine performed better and identified a set of simple intelligible rules based on a combination of clinical variables and gene expressions. Decision Tree identified a non-coding gene ( XIST) involved in the early phases of X chromosome inactivation that was overexpressed in females and in non-relapsed patients. XIST expression might be responsible for the better prognosis of female Hodgkin's lymphoma patients.

Nerve Ultrasound and Electrophysiology for Therapy Monitoring in Chronic Inflammatory Demyelinating Polyneuropathy.

PubMed

Kerasnoudis, Antonios; Pitarokoili, Kalliopi; Gold, Ralf; Yoon, Min-Suk

2015-01-01

We evaluated prospectively nerve ultrasound and electrophysiology as monitoring methods of intravenous immunoglobulin (IVIG) therapy in chronic inflammatory demyelinating polyneuropathy (CIDP). Overall 15 healthy subjects and 11 CIDP patients undergoing IVIG therapy were recruited in the study. All patients underwent clinical, ultrasound, and electrophysiological evaluation at the time point of first onset of symptoms (<6 weeks of symptoms) and 4, 8, and 12 months after onset. The intranerve cross-sectional area (CSA) variability of each nerve, but not the CSA alone, correlated with the MRC Scale score during 12-month follow-up. On the other hand, none of the electrophysiological parameters correlated with the MRC Scale Score in each of the peripheral nerves. Interestingly, in ¾ of the CIDP patients, the resolution of the conduction block correlated with the improvement in the MRC Sum score. Nerve ultrasound and in particular the intranerve CSA variability seems to be a useful method in monitoring CIDP patients. Although the sample size is small, the intranerve CSA variability seems to be more promising than neurophysiology. Copyright © 2015 by the American Society of Neuroimaging.

Culture as a variable in neuroscience and clinical neuropsychology: A comprehensive review

PubMed Central

Wajman, José Roberto; Bertolucci, Paulo Henrique Ferreira; Mansur, Letícia Lessa; Gauthier, Serge

2015-01-01

Culture is a dynamic system of bidirectional influences among individuals and their environment, including psychological and biological processes, which facilitate adaptation and social interaction. One of the main challenges in clinical neuropsychology involves cognitive, behavioral and functional assessment of people with different sociocultural backgrounds. In this review essay, examining culture from a historical perspective to ethical issues in cross-cultural research, including the latest significant and publications, the authors sought to explore the main features related to cultural variables in neuropsychological practice and to debate the challenges found regarding the operational methods currently in use. Literature findings suggest a more comprehensive approach in cognitive and behavioral neuroscience, including an interface between elementary disciplines and applied neuropsychology. Thus, as a basis for discussion on this issue, the authors analyzed key-topics related to the study of new trends in sociocultural neuroscience and the application of their concepts from a clinical perspective. PMID:29213964

Set-shifting and its relation to clinical and personality variables in full recovery of anorexia nervosa.

PubMed

Lindner, Susanne E; Fichter, Manfred M; Quadflieg, Norbert

2014-07-01

First, this study aimed to explore whether set-shifting is inefficient after full recovery of anorexia nervosa (recAN). Second, this study wanted to explore the relation of set-shifting to clinical and personality variables. A total of 100 recAN women were compared with 100 healthy women. Set-shifting was assessed with Berg's Card Sorting Test. Expert interviews yielded assessments for the inclusion/exclusion criteria, self-ratings for clinical and personality variables. Compared with the healthy control group, the recAN participants achieved fewer categories, showed more perseverations and spent less time for shifting set. Perfectionism is correlated with set-shifting but in converse directions in the two groups. Our study supports the findings of inefficiencies in set-shifting after full recovery from AN. Higher perfectionism in the recAN group is associated with better set-shifting ability, whereas higher perfectionism in the healthy control group is related to worse set-shifting ability. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association.

Post-marketing health technology monitoring. The analysis of an experience from a clinical perspective.

PubMed

Ibargoyen-Roteta, Nora; Cabriada-Nuño, Jose Luis; Gutiérrez-Ibarluzea, Iñaki; Hernández-Ramírez, Vicent; Clofent-Vilaplana, Juan; Domènech-Morral, Eugeni; Ginard-Vicens, Daniel; Oliva-Oliva, Gloria; Queiro-Verdes, Teresa

2011-01-01

A system for monitoring the use of aphaeresis in the treatment of ulcerative colitis (UC), named system for monitoring aphaeresis in ulcerative colitis (SiMAC), was designed in 2006 in the Basque Country. In the present study, the opinion of the clinicians who participated in SiMAC was evaluated, in order to identify the barriers and gather suggestions that could improve implementation of this kind of system. A mixed questionnaire was designed, in order to gather clinicians' assessments of the SiMAC monitoring system. The response rate was 73.9% (17/23). The data from 40.96% (159/388) of patients with UC treated with aphaeresis was recorded. The main reasons for not including the data from all treated patients were a lack of required data or not meeting the study inclusion criteria. Positive aspects of the SiMAC were identified, as the simplicity of data collection and its systematic, multi-center approach. The negative aspects mentioned were the use of a local computer application and the lack of time for health professionals to enter data. The use of monitoring systems helps to formalize the introduction of technologies of little-known effectiveness; involve clinicians and medical societies in coming to agreement and obtaining information about the safety, effectiveness or efficiency of new technologies; and provide relevant information to healthcare administrations for making decisions about the introduction of new technologies into healthcare practice. In order for a monitoring system to work, the process must be straightforward. A minimum set of key variables that are easy to collect must be selected, and an effort made to involve a range of stakeholders, especially institutions and scientific societies, to support the work group.

Cancer biomarker discovery is improved by accounting for variability in general levels of drug sensitivity in pre-clinical models.

PubMed

Geeleher, Paul; Cox, Nancy J; Huang, R Stephanie

2016-09-21

We show that variability in general levels of drug sensitivity in pre-clinical cancer models confounds biomarker discovery. However, using a very large panel of cell lines, each treated with many drugs, we could estimate a general level of sensitivity to all drugs in each cell line. By conditioning on this variable, biomarkers were identified that were more likely to be effective in clinical trials than those identified using a conventional uncorrected approach. We find that differences in general levels of drug sensitivity are driven by biologically relevant processes. We developed a gene expression based method that can be used to correct for this confounder in future studies.

Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators.

PubMed

Zabel, Markus; Müller-Riemenschneider, Falk; Geller, J Christoph; Brachmann, Johannes; Kühlkamp, Volker; Dissmann, Rüdiger; Reinhold, Thomas; Roll, Stephanie; Lüthje, Lars; Bode, Frank; Eckardt, Lars; Willich, Stefan N

2014-10-01

Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial. Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points. The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM. Copyright © 2014 Mosby, Inc. All rights reserved.

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure.

PubMed

Kim, Yoon-Nyun; Shin, Dong Gu; Park, Sungha; Lee, Chang Hee

2015-07-01

The effectiveness of remote patient monitoring and physician care for the treatment of hypertension has not been demonstrated in a randomized clinical trial. The objective of this study was to evaluate the effectiveness of remote patient monitoring with or without remote physician care in reducing office blood pressure in patients with hypertension. A total of 374 hypertensive patients over 20 years of age were randomized into the following three groups: group (1) control, the patients received usual clinical care with home BP monitoring; group (2) the patients were remotely monitored and received office follow-up; and group (3) the patients received remote monitoring without physician office care using the remote monitoring device. For each group, in-office follow-up care was scheduled every 8 weeks for 24 weeks. The primary end point was the difference in sitting SBP at the 24-week follow-up. No difference between the three groups was observed in the primary end point (adjusted mean sitting SBP was as follows: group 1: -8.9±15.5 mm Hg, group 2: -11.3±15.9 mm Hg, group 3: -11.6±19.8 mm Hg, (NS). Significant differences in achieving the target BP at the 24th week of follow-up were observed between groups 1 and 2. The subjects over 55-years old had a significant decrease in the adjusted mean sitting SBP in groups 2 and 3 compared with that of the control group. Remote monitoring alone or remote monitoring coupled with remote physician care was as efficacious as the usual office care for reducing blood pressure with comparable safety and efficacy in hypertensive patients.

Clinical Malaria Transmission Trends and Its Association with Climatic Variables in Tubu Village, Botswana: A Retrospective Analysis.

PubMed

Chirebvu, Elijah; Chimbari, Moses John; Ngwenya, Barbara Ntombi; Sartorius, Benn

2016-01-01

Good knowledge on the interactions between climatic variables and malaria can be very useful for predicting outbreaks and preparedness interventions. We investigated clinical malaria transmission patterns and its temporal relationship with climatic variables in Tubu village, Botswana. A 5-year retrospective time series data analysis was conducted to determine the transmission patterns of clinical malaria cases at Tubu Health Post and its relationship with rainfall, flood discharge, flood extent, mean minimum, maximum and average temperatures. Data was obtained from clinical records and respective institutions for the period July 2005 to June 2010, presented graphically and analysed using the Univariate ANOVA and Pearson cross-correlation coefficient tests. Peak malaria season occurred between October and May with the highest cumulative incidence of clinical malaria cases being recorded in February. Most of the cases were individuals aged >5 years. Associations between the incidence of clinical malaria cases and several factors were strong at lag periods of 1 month; rainfall (r = 0.417), mean minimum temperature (r = 0.537), mean average temperature (r = 0.493); and at lag period of 6 months for flood extent (r = 0.467) and zero month for flood discharge (r = 0.497). The effect of mean maximum temperature was strongest at 2-month lag period (r = 0.328). Although malaria transmission patterns varied from year to year the trends were similar to those observed in sub-Saharan Africa. Age group >5 years experienced the greatest burden of clinical malaria probably due to the effects of the national malaria elimination programme. Rainfall, flood discharge and extent, mean minimum and mean average temperatures showed some correlation with the incidence of clinical malaria cases.

The UK Infrared Telescope M33 monitoring project - I. Variable red giant stars in the central square kiloparsec

NASA Astrophysics Data System (ADS)

Javadi, Atefeh; van Loon, Jacco Th.; Mirtorabi, Mohammad Taghi

2011-02-01

We have conducted a near-infrared monitoring campaign at the UK Infrared Telescope (UKIRT), of the Local Group spiral galaxy M33 (Triangulum). The main aim was to identify stars in the very final stage of their evolution, and for which the luminosity is more directly related to the birth mass than the more numerous less-evolved giant stars that continue to increase in luminosity. The most extensive data set was obtained in the K band with the UIST instrument for the central 4 × 4 arcmin2 (1 kpc2) - this contains the nuclear star cluster and inner disc. These data, taken during the period 2003-2007, were complemented by J- and H-band images. Photometry was obtained for 18 398 stars in this region; of these, 812 stars were found to be variable, most of which are asymptotic giant branch (AGB) stars. Our data were matched to optical catalogues of variable stars and carbon stars and to mid-infrared photometry from the Spitzer Space Telescope. In this first of a series of papers, we present the methodology of the variability survey and the photometric catalogue - which is made publicly available at the Centre de Données astronomiques de Strasbourg - and discuss the properties of the variable stars. The most dusty AGB stars had not been previously identified in optical variability surveys, and our survey is also more complete for these types of stars than the Spitzer survey.

[Final clinical indications and etiology in 1,023 enucleations. Descriptive databank evaluation with SPSS software in variable response mode with dummy variables].

PubMed

Becker, H; Bialasiewicz, A A; Schaudig, U; Schäfer, H; von Domarus, D

2002-05-01

A new data bank developed for ophthalmopathology using a computer-generated, multidigital data code is expected to be able to accomplish complex clinicopathologic correlations of diagnoses and signs, as provided by (multiple) clinical events and histopathologically proven etiologies, and to facilitate the documentation of new data. In the ophthalmopathology laboratory 2890 eyes were examined between January 20, 1975 and December 12, 1996. The main diagnoses and patient data from this 22-year period were recorded. To facilitate the presentation of data, a 10-year period with eyes of 976 patients enucleated from December, 1986 to December, 1996 was chosen. Principal and secondary diagnoses served for establishing the data bank. The frequencies of successive histologic and clinical diagnoses were evaluated by a descriptive computing program using an SPSS-multi-response mode with dummy variables and a categorical variable listing of the software (SPSS version 10.0) classified as (a) non-filtered random, (b) filtered by multiple etiologies, and (c) filtered by multiple events. The principal groups (e.g., histologic diagnoses concerning etiology) and subgroups (e.g., trauma, neoplasia, surgery, systemic diseases, and inflammations) were defined and correlated with 798 separate diagnoses. From 11 diagnoses/events ascribed to the clinical cases, 11,198 namings resulted. Thus, a comparative study of complex etiologies and events leading to enucleation in different hospitals of a specific area may be performed using this electronic ophthalmopathologic data bank system. The complexity of rare disease and integration into a superimposed structure can be managed with this custom-made data bank. A chronologically and demographically oriented consideration of reasons for enucleation is thus feasible.

Executive function impairments in fibromyalgia syndrome: Relevance of clinical variables and body mass index.

PubMed

Muñoz Ladrón de Guevara, Cristina; Fernández-Serrano, María José; Reyes Del Paso, Gustavo A; Duschek, Stefan

2018-01-01

Several investigations suggest the presence of deterioration of executive function in fibromyalgia syndrome (FMS). The study quantified executive functions in patients with FMS. A wide array of functions was assessed, including updating, shifting and inhibition, as well as decision making and mental planning. Moreover, clinical variables were investigated as possible mediators of executive dysfunction, including pain severity, psychiatric comorbidity, medication and body mass index (BMI). Fifty-two FMS patients and 32 healthy controls completed a battery of 14 neuropsychological tests. Clinical interviews were conducted and the McGill Pain Questionnaire, Beck Depression Inventory, State-Trait Anxiety Inventory, Fatigue Severity Scale and Oviedo Quality of Sleep Questionnaire were presented. Patients performed poorer than controls on the Letter Number Sequencing, Arithmetic and Similarities subtests of the Wechsler Adult Intelligence Scale, the Spatial Span subtest of the Wechsler Memory Scale, an N-back task, a verbal fluency task, the Ruff Figural Fluency Test, the Inhibition score of the Stroop Test, the Inhibition and Shifting scores of the Five Digits Test, the Key Search Test and the Zoo Map Task. Moreover, patients exhibited less steep learning curves on the Iowa Gambling Task. Among clinical variables, BMI and pain severity explained the largest proportion of performance variance. This study demonstrated impairments in executive functions of updating, shifting inhibition, decision making and planning in FMS. While the mediating role of pain in cognitive impairments in FMS had been previously established, the influence of BMI is a novel finding. Overweight and obesity should be considered by FMS researchers, and in the treatment of the condition.

Mandibular bone structure, bone mineral density, and clinical variables as fracture predictors: a 15-year follow-up of female patients in a dental clinic.

PubMed

Jonasson, Grethe; Billhult, Annika

2013-09-01

To compare three mandibular trabeculation evaluation methods, clinical variables, and osteoporosis as fracture predictors in women. One hundred and thirty-six female dental patients (35-94 years) answered a questionnaire in 1996 and 2011. Using intra-oral radiographs from 1996, five methods were compared as fracture predictors: (1) mandibular bone structure evaluated with a visual radiographic index, (2) bone texture, (3) size and number of intertrabecular spaces calculated with Jaw-X software, (4) fracture probability calculated with a fracture risk assessment tool (FRAX), and (5) osteoporosis diagnosis based on dual-energy-X-ray absorptiometry. Differences were assessed with the Mann-Whitney test and relative risk calculated. Previous fracture, gluco-corticoid medication, and bone texture were significant indicators of future and total (previous plus future) fracture. Osteoporosis diagnosis, sparse trabeculation, Jaw-X, and FRAX were significant predictors of total but not future fracture. Clinical and oral bone variables may identify individuals at greatest risk of fracture. Copyright © 2013 Elsevier Inc. All rights reserved.

Prevalence of Substance Misuse in New Patients in an Outpatient Psychiatry Clinic Using a Prescription Monitoring Program

PubMed Central

Fellers, Jonathan C.; Raisinghani, Rachna S.; Santa Cruz, Maria R.; Hidalgo, Priscilla C.; Lee, Meredith S.; Martinez, Lady A.; Keller, Adrienne E.; Clayton, Anita H.

2014-01-01

Objective: To investigate the value of a prescription monitoring program in identifying prescription drug misuse among patients presenting to a resident physician outpatient psychiatry clinic at an academic medical center. Method: Participants were 314 new patients aged 18 years or older presenting to the clinic from October 2011 to June 2012. Resident physicians completed a data collection form for each participant using information from the patient interview and from the prescription monitoring program report. Prescription drug misuse was defined as having any 1 of the following 5 criteria in the prescription monitoring program report: (1) filled prescriptions for 2 or more controlled substances, (2) obtained prescriptions from 2 or more providers, (3) obtained early refills, (4) used 3 or more pharmacies, and (5) the prescription monitoring program report conflicted with the patient’s report. Results: At least 1 indicator of prescription drug misuse was found in 41.7% of patients. Over 69% of the patients that the residents believed were misusing prescription drugs actually met 1 of the criteria for prescription drug misuse. The prescription monitoring program report changed the management only 2.2% of the time. Patients with prior benzodiazepine use (χ21 = 17.68, P < .001), prior opioid use (χ21 = 19.98, P < .001), a personality disorder (χ21 = 7.22, P < .001), and chronic pain (χ21 = 14.31, P < .001) had a higher percentage of prescription drug misuse compared to patients without these factors. Conclusion: Using the prescription monitoring program to screen patients with prior benzodiazepine and opioid use, with a personality disorder, and/or with chronic pain may be useful in confirming the suspicion of prescription drug misuse identified at the initial evaluation. PMID:24940523

Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation

PubMed Central

2016-01-01

Background Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3–12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. Objective The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a “real world” context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. Methods A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. Results In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM

[Respiratory monitoring of pediatric patients in the Intensive Care Unit].

PubMed

Donoso, Alejandro; Arriagada, Daniela; Contreras, Dina; Ulloa, Daniela; Neumann, Megan

Respiratory monitoring plays an important role in the care of children with acute respiratory failure. Therefore, its proper use and correct interpretation (recognizing which signals and variables should be prioritized) should help to a better understanding of the pathophysiology of the disease and the effects of therapeutic interventions. In addition, ventilated patient monitoring, among other determinations, allows to evaluate various parameters of respiratory mechanics, know the status of the different components of the respiratory system and guide the adjustments of ventilatory therapy. In this update, the usefulness of several techniques of respiratory monitoring including conventional respiratory monitoring and more recent methods are described. Moreover, basic concepts of mechanical ventilation, their interpretation and how the appropriate analysis of the information obtained can cause an impact on the clinical management of the patient are defined. Copyright © 2016 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

Near-infrared Variability in the Orion Nebula Cluster

NASA Astrophysics Data System (ADS)

Rice, Thomas S.; Reipurth, Bo; Wolk, Scott J.; Vaz, Luiz Paulo; Cross, N. J. G.

2015-10-01

Using UKIRT on Mauna Kea, we have carried out a new near-infrared J, H, K monitoring survey of almost a square degree of the star-forming Orion Nebula Cluster with observations on 120 nights over three observing seasons, spanning a total of 894 days. We monitored ˜15,000 stars down to J≈ 20 using the WFCAM instrument, and have extracted 1203 significantly variable stars from our data. By studying variability in young stellar objects (YSOs) in the H - K, K color-magnitude diagram, we are able to distinguish between physical mechanisms of variability. Many variables show color behavior indicating either dust-extinction or disk/accretion activity, but we find that when monitored for longer periods of time, a number of stars shift between these two variability mechanisms. Further, we show that the intrinsic timescale of disk/accretion variability in young stars is longer than that of dust-extinction variability. We confirm that variability amplitude is statistically correlated with evolutionary class in all bands and colors. Our investigations of these 1203 variables have revealed 73 periodic AA Tau type variables, many large-amplitude and long-period (P\\gt 15 days) YSOs, including three stars showing widely spaced periodic brightening events consistent with circumbinary disk activity, and four new eclipsing binaries. These phenomena and others indicate the activity of long-term disk/accretion variability processes taking place in young stars. We have made the light curves and associated data for these 1203 variables available online.

Validity of the Polar V800 monitor for measuring heart rate variability in mountain running route conditions.

PubMed

Caminal, Pere; Sola, Fuensanta; Gomis, Pedro; Guasch, Eduard; Perera, Alexandre; Soriano, Núria; Mont, Lluis

2018-03-01

This study was conducted to test, in mountain running route conditions, the accuracy of the Polar V800™ monitor as a suitable device for monitoring the heart rate variability (HRV) of runners. Eighteen healthy subjects ran a route that included a range of running slopes such as those encountered in trail and ultra-trail races. The comparative study of a V800 and a Holter SEER 12 ECG Recorder™ included the analysis of RR time series and short-term HRV analysis. A correction algorithm was designed to obtain the corrected Polar RR intervals. Six 5-min segments related to different running slopes were considered for each subject. The correlation between corrected V800 RR intervals and Holter RR intervals was very high (r = 0.99, p < 0.001), and the bias was less than 1 ms. The limits of agreement (LoA) obtained for SDNN and RMSSD were (- 0.25 to 0.32 ms) and (- 0.90 to 1.08 ms), respectively. The effect size (ES) obtained in the time domain HRV parameters was considered small (ES < 0.2). Frequency domain HRV parameters did not differ (p > 0.05) and were well correlated (r ≥ 0.96, p < 0.001). Narrow limits of agreement, high correlations and small effect size suggest that the Polar V800 is a valid tool for the analysis of heart rate variability in athletes while running high endurance events such as marathon, trail, and ultra-trail races.

Continuous glucose monitoring in acute coronary syndrome.

PubMed

Rodríguez-Quintanilla, Karina Alejandra; Lavalle-González, Fernando Javier; Mancillas-Adame, Leonardo Guadalupe; Zapata-Garrido, Alfonso Javier; Villarreal-Pérez, Jesús Zacarías; Tamez-Pérez, Héctor Eloy

2013-01-01

Diabetes mellitus is an independent risk factor for cardiovascular disease. To compare the efficacy of devices for continuous glucose monitoring and capillary glucose monitoring in hospitalized patients with acute coronary syndrome using the following parameters: time to achieve normoglycemia, period of time in normoglycemia, and episodes of hypoglycemia. We performed a pilot, non-randomized, unblinded clinical trial that included 16 patients with acute coronary artery syndrome, a capillary or venous blood glucose ≥ 140 mg/dl, and treatment with a continuous infusion of fast acting human insulin. These patients were randomized into 2 groups: a conventional group, in which capillary measurement and recording as well as insulin adjustment were made every 4h, and an intervention group, in which measurement and recording as well as insulin adjustment were made every hour with a subcutaneous continuous monitoring system. Student's t-test was applied for mean differences and the X(2) test for qualitative variables. We observed a statistically significant difference in the mean time for achieving normoglycemia, favoring the conventional group with a P = 0.02. Continuous monitoring systems are as useful as capillary monitoring for achieving normoglycemia. Copyright © 2012 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

Clinical implications and economic impact of accuracy differences among commercially available blood glucose monitoring systems.

PubMed

Budiman, Erwin S; Samant, Navendu; Resch, Ansgar

2013-03-01

Despite accuracy standards, there are performance differences among commercially available blood glucose monitoring (BGM) systems. The objective of this analysis was to assess the potential clinical and economic impact of accuracy differences of various BGM systems using a modeling approach. We simulated additional risk of hypoglycemia due to blood glucose (BG) measurement errors of five different BGM systems based on results of a real-world accuracy study, while retaining other sources of glycemic variability. Using data from published literature, we estimated an annual additional number of required medical interventions as a result of hypoglycemia. We based our calculations on patients with type 1 diabetes mellitus (T1DM) and T2DM requiring multiple daily injections (MDIs) of insulin in a U.S. health care system. We estimated additional costs attributable to treatment of severe hypoglycemic episodes resulting from BG measurement errors. Results from our model predict an annual difference of approximately 296,000 severe hypoglycemic episodes from BG measurement errors for T1DM (105,000 for T2DM MDI) patients for the estimated U.S. population of 958,800 T1DM and 1,353,600 T2DM MDI patients, using the least accurate BGM system versus patients using the most accurate system in a U.S. health care system. This resulted in additional direct costs of approximately $339 million for T1DM and approximately $121 million for T2DM MDI patients per year. Our analysis shows that error patterns over the operating range of BGM meter may lead to relevant clinical and economic outcome differences that may not be reflected in a common accuracy metric or standard. Further research is necessary to validate the findings of this model-based approach. © 2013 Diabetes Technology Society.

Clinical Implications and Economic Impact of Accuracy Differences among Commercially Available Blood Glucose Monitoring Systems

PubMed Central

Budiman, Erwin S.; Samant, Navendu; Resch, Ansgar

2013-01-01

Background Despite accuracy standards, there are performance differences among commercially available blood glucose monitoring (BGM) systems. The objective of this analysis was to assess the potential clinical and economic impact of accuracy differences of various BGM systems using a modeling approach. Methods We simulated additional risk of hypoglycemia due to blood glucose (BG) measurement errors of five different BGM systems based on results of a real-world accuracy study, while retaining other sources of glycemic variability. Using data from published literature, we estimated an annual additional number of required medical interventions as a result of hypoglycemia. We based our calculations on patients with type 1 diabetes mellitus (T1DM) and T2DM requiring multiple daily injections (MDIs) of insulin in a U.S. health care system. We estimated additional costs attributable to treatment of severe hypoglycemic episodes resulting from BG measurement errors.. Results Results from our model predict an annual difference of approximately 296,000 severe hypoglycemic episodes from BG measurement errors for T1DM (105,000 for T2DM MDI) patients for the estimated U.S. population of 958,800 T1DM and 1,353,600 T2DM MDI patients, using the least accurate BGM system versus patients using the most accurate system in a U.S. health care system. This resulted in additional direct costs of approximately $339 million for T1DM and approximately $121 million for T2DM MDI patients per year. Conclusions Our analysis shows that error patterns over the operating range of BGM meter may lead to relevant clinical and economic outcome differences that may not be reflected in a common accuracy metric or standard. PMID:23566995

Monitoring Spatial Variability and Temporal Dynamics of Phragmites Using Unmanned Aerial Vehicles

PubMed Central

Tóth, Viktor R.

2018-01-01

Littoral zones of freshwater lakes are exposed to environmental impacts from both terrestrial and aquatic sides, while substantial anthropogenic pressure also affects the high spatial, and temporal variability of the ecotone. In this study, the possibility of monitoring seasonal and spatial changes in reed (Phragmites australis) stands using an unmanned aerial vehicle (UAV) based remote sensing technique was examined. Stands in eutrophic and mesotrophic parts of Lake Balaton including not deteriorating (stable) and deteriorating (die-back) patches, were tracked throughout the growing season using a UAV equipped with a Normalized Difference Vegetation Index (NDVI) camera. Photophysiological parameters of P. australis were also measured with amplitude modulated fluorescence. Parameters characterizing the dynamics of seasonal changes in NDVI data were used for phenological comparison of eutrophic and mesotrophic, stable and die-back, terrestrial and aquatic, mowed and not-mowed patches of reed. It was shown that stable Phragmites plants from the eutrophic part of the lake reached specific phenological stages up to 3.5 days earlier than plants from the mesotrophic part of the lake. The phenological changes correlated with trophic (total and nitrate-nitrite nitrogen) and physical (organic C and clay content) properties of the sediment, while only minor relationships with air and water temperature were found. Phenological differences between the stable and die-back stands were even more pronounced, with ~34% higher rates of NDVI increase in stable than die-back patches, while the period of NDVI increase was 16 days longer. Aquatic and terrestrial parts of reed stands showed no phenological differences, although intermediate areas (shallow water parts of stands) were found to be less vigorous. Winter mowing of dried Phragmites sped up sprouting and growth of reed in the spring. This study showed that remote sensing-derived photophysiological and phenological variability

Consensus Report of the Coalition for Clinical Research—Self-Monitoring of Blood Glucose

PubMed Central

Klonoff, David C.; Bergenstal, Richard; Blonde, Lawrence; Boren, Suzanne Austin; Church, Timothy S.; Gaffaney, Jenifer; Jovanovič, Lois; Kendall, David M.; Kollman, Craig; Kovatchev, Boris P.; Leippert, Claudia; DDG, Diabetesberaterin; Owens, David R.; Polonsky, William H.; Reach, Gérard; Renard, Eric; Riddell, Michael C.; Rubin, Richard R.; Schnell, Oliver; Siminiero, Linda M.; Vigersky, Robert A.; Wilson, Darrell M.; Wollitzer, Alison Okada

2008-01-01

The Coalition for Clinical Research—Self-Monitoring of Blood Glucose Scientific Board, a group of nine academic clinicians and scientists from the United States and Europe, convened in San Francisco, California, on June 11–12, 2008, to discuss the appropriate uses of self-monitoring of blood glucose (SMBG) and the measures necessary to accurately assess the potential benefit of this practice in noninsulin-treated type 2 diabetes mellitus (T2DM). Thirteen consultants from the United States, Europe, and Canada from academia, practice, and government also participated and contributed based on their fields of expertise. These experts represent a range of disciplines that include adult endocrinology, pediatric endocrinology, health education, mathematics, statistics, psychology, nutrition, exercise physiology, and nursing. This coalition was organized by Diabetes Technology Management, Inc. Among the participants, there was consensus that: protocols assessing the performance of SMBG in noninsulin treated T2DM must provide the SMBG intervention subjects with blood glucose (BG) goals and instructions on how to respond to BG data in randomized controlled trials (RCTs);intervention subjects in clinical trials of SMBG-driven interventions must aggressively titrate their therapeutic responses or lifestyle changes in response to hyperglycemia;control subjects in clinical trials of SMBG must be isolated from SMBG-driven interventions and not be contaminated by physician experience with study subjects receiving a SMBG intervention;the best endpoints to measure in a clinical trial of SMBG in T2DM include delta Hemoglobin A1c levels, hyperglycemic events, hypoglycemic events, time to titrate noninsulin therapy to a maximum necessary dosage, and quality of life indices;either individual randomization or cluster randomization may be appropriate methods for separating control subjects from SMBG intervention subjects, provided that precautions are taken to avoid bias and that the

Mass Spectrometry for Research and Application in Therapeutic Drug Monitoring or Clinical and Forensic Toxicology.

PubMed

Maurer, Hans H

2018-04-30

This paper reviews current applications of various hyphenated low- and high-resolution mass spectrometry techniques in the field of therapeutic drug monitoring and clinical/forensic toxicology in both research and practice. They cover gas chromatography, liquid chromatography, matrix-assisted laser desorption ionization, or paper spray ionization coupled to quadrupole, ion trap, time-of-flight, or Orbitrap mass analyzers.

Advanced hemodynamic monitoring in intensive care medicine : A German web-based survey study.

PubMed

Saugel, B; Reese, P C; Wagner, J Y; Buerke, M; Huber, W; Kluge, S; Prondzinsky, R

2018-04-01

Advanced hemodynamic monitoring is recommended in patients with complex circulatory shock. To evaluate the current attitudes and beliefs among German intensivists, regarding advanced hemodynamic monitoring, the actual hemodynamic management in clinical practice, and the barriers to using it. Web-based survey among members of the German Society of Medical Intensive Care and Emergency Medicine. Of 284 respondents, 249 (87%) agreed that further hemodynamic assessment is needed to determine the type of circulatory shock if no clear clinical diagnosis can be made. In all, 281 (99%) agreed that echocardiography is helpful for this purpose (transpulmonary thermodilution: 225 [79%]; pulmonary artery catheterization: 126 [45%]). More than 70% of respondents agreed that blood flow variables (cardiac output, stroke volume) should be measured in patients with hemodynamic instability. The parameters most respondents agreed should be assessed in a patient with hemodynamic instability were mean arterial pressure, cardiac output, and serum lactate. Echocardiography is available in 99% of ICUs (transpulmonary thermodilution: 91%; pulmonary artery catheter: 63%). The respondents stated that, in clinical practice, invasive arterial pressure measurements and serum lactate measurements are performed in more than 90% of patients with hemodynamic instability (cardiac output monitoring in about 50%; transpulmonary thermodilution in about 40%). The respondents did not feel strong barriers to the use of advanced hemodynamic monitoring in clinical practice. This survey study shows that German intensivists deem advanced hemodynamic assessment necessary for the differential diagnosis of circulatory shock and to guide therapy with fluids, vasopressors, and inotropes in ICU patients.

Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial.

PubMed

Ryan, Dermot; Price, David; Musgrave, Stan D; Malhotra, Shweta; Lee, Amanda J; Ayansina, Dolapo; Sheikh, Aziz; Tarassenko, Lionel; Pagliari, Claudia; Pinnock, Hilary

2012-03-23

To determine whether mobile phone based monitoring improves asthma control compared with standard paper based monitoring strategies. Multicentre randomised controlled trial with cost effectiveness analysis. UK primary care. 288 adolescents and adults with poorly controlled asthma (asthma control questionnaire (ACQ) score ≥ 1.5) from 32 practices. Participants were centrally randomised to twice daily recording and mobile phone based transmission of symptoms, drug use, and peak flow with immediate feedback prompting action according to an agreed plan or paper based monitoring. Changes in scores on asthma control questionnaire and self efficacy (knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)) at six months after randomisation. Assessment of outcomes was blinded. Analysis was on an intention to treat basis. There was no significant difference in the change in asthma control or self efficacy between the two groups (ACQ: mean change 0.75 in mobile group v 0.73 in paper group, mean difference in change -0.02 (95% confidence interval -0.23 to 0.19); KASE-AQ score: mean change -4.4 v -2.4, mean difference 2.0 (-0.3 to 4.2)). The numbers of patients who had acute exacerbations, steroid courses, and unscheduled consultations were similar in both groups, with similar healthcare costs. Overall, the mobile phone service was more expensive because of the expenses of telemonitoring. Mobile technology does not improve asthma control or increase self efficacy compared with paper based monitoring when both groups received clinical care to guidelines standards. The mobile technology was not cost effective. Clinical Trials NCT00512837.

Monitoring Thyroid Function in Patients on Levothyroxine. Assessment of Conformity to National Guidance and Variability in Practice.

PubMed

Scargill, Jonathan J; Livingston, Mark; Holland, David; Duff, Christopher J; Fryer, Anthony A; Heald, Adrian H

2017-10-01

With demand for endocrine tests steadily increasing year-on-year, we examined thyroid function test (TFT) frequencies in patients on levothyroxine replacement therapy to assess the effect of initial TFT results and request source on TFT re-testing interval. All TFTs performed by the Clinical Biochemistry Departments at the Salford Royal Hospital (2009-2012; 288 263 requests from 139 793 patients) and University Hospital of North Midlands (2011-2014; 579 156 requests from 193 035 patients) were extracted from the laboratory computer systems. Of these, 54 894 tests were on 13 297 patients confirmed to be on levothyroxine therapy in the test cohort (Salford) and 67 298 requests on 11 971 patients in the confirmatory cohort (North Midlands). In the test cohort, median TFT re-testing interval in the total group was 19.1 weeks (IQR 9.1-37.7 weeks), with clearly defined peaks in TFT re-testing evident at 6 and 12 months and a prominent broad peak at 1-3 months. Median re-test interval was much lower than recommended (52 weeks) for those with normal TFTs at 31.3 weeks (30.6 weeks for the confirmatory cohort). Where thyroid-stimulating hormone (TSH) was elevated and free thyroxine (fT4) was below the reference range, re-test interval was much longer than is recommended (8 weeks) at 13.4-17.6 weeks (7.1-23.4 weeks in the confirmatory cohort), as was the interval when TSH was below and fT4 was above the normal range, at 16.7-25.6 weeks (27.5-31.9 weeks in the confirmatory cohort). Our findings show that the majority of TFT requests are requested outside recommended intervals and within-practice variability is high. A new approach to ensuring optimum monitoring frequency is required. Direct requesting from the clinical laboratory may provide one such solution. © Georg Thieme Verlag KG Stuttgart · New York.

A framework for monitoring-based commissioning: Identifying variables that act as barriers and enablers to the process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harris, Nora; Shealy, Tripp; Kramer, Hannah

The practice of monitoring-based commissioning (MBCx) using energy management and information systems (EMIS) has been shown to enable and help sustain up to 20% energy savings in buildings. Despite research that has quantified the costs, benefits, and energy savings of MBCx, the process remains under-utilized. To understand why MBCx is not more frequently adopted and how to encourage its use, this research synthesizes qualitative data from over 40 organizations, currently engaging in MBCx. The outcome of this research is a framework containing variables that emerged from the qualitative data, marked as barriers or enablers, organized by phases of the MBCxmore » process. The framework is comprised of 51 emergent variables that fall within 13 different categories. The variables that most frequently act as barriers are data configuration, measurement & verification (M&V), developing specifications for EMIS, and data architecture. Although some variables that act as barriers for one organization were identified as enablers for another. For example, payback/ROI was considered a barrier 7 times and an enabler 3 times. One organization had difficulty making the business case for the initial investment for MBCx due to lack of cost information, while another was able to justify large investments with documented savings of previously implemented measures identified through MBCx. The framework formally validates barriers found in previous research, and can be used by practitioners to better understand common experiences with MBCx. This research also highlights the need for a similar collective data set to validate common enablers to MBCx and also the need for empirical research to determine relationships between variables.« less

A framework for monitoring-based commissioning: Identifying variables that act as barriers and enablers to the process

DOE PAGES

Harris, Nora; Shealy, Tripp; Kramer, Hannah; ...

2018-03-16

The practice of monitoring-based commissioning (MBCx) using energy management and information systems (EMIS) has been shown to enable and help sustain up to 20% energy savings in buildings. Despite research that has quantified the costs, benefits, and energy savings of MBCx, the process remains under-utilized. To understand why MBCx is not more frequently adopted and how to encourage its use, this research synthesizes qualitative data from over 40 organizations, currently engaging in MBCx. The outcome of this research is a framework containing variables that emerged from the qualitative data, marked as barriers or enablers, organized by phases of the MBCxmore » process. The framework is comprised of 51 emergent variables that fall within 13 different categories. The variables that most frequently act as barriers are data configuration, measurement & verification (M&V), developing specifications for EMIS, and data architecture. Although some variables that act as barriers for one organization were identified as enablers for another. For example, payback/ROI was considered a barrier 7 times and an enabler 3 times. One organization had difficulty making the business case for the initial investment for MBCx due to lack of cost information, while another was able to justify large investments with documented savings of previously implemented measures identified through MBCx. The framework formally validates barriers found in previous research, and can be used by practitioners to better understand common experiences with MBCx. This research also highlights the need for a similar collective data set to validate common enablers to MBCx and also the need for empirical research to determine relationships between variables.« less

Differences in activation of MAP kinases and variability in the polyglutamine tract of Slt2 in clinical and non-clinical isolates of Saccharomyces cerevisiae.

PubMed

de Llanos, Rosa; Hernández-Haro, Carolina; Barrio, Eladio; Querol, Amparo; Fernández-Espinar, María Teresa; Molina, María

2010-08-01

The concept of Saccharomyces cerevisiae as an emerging opportunistic pathogen is relatively new and it is due to an increasing number of human infections during the past 20 years. There are still few studies addressing the mechanisms of infection of this yeast species. Moreover, little is known about how S. cerevisiae cells sense and respond to the harsh conditions imposed by the host, and whether this response is different between clinical isolates and non-pathogenic strains. In this regard, mitogen-activated protein kinase (MAPK) pathways constitute one of the major mechanisms for controlling transcriptional responses and, in some cases, virulence in fungi. Here we show differences among clinical and non-clinical isolates of S. cerevisiae in the level of activation of the MAPKs Kss1, which controls pseudohyphal and invasive growth, and Slt2, which is required for maintaining the integrity of the cell wall under stress conditions and in the absence of stimulating conditions. Moreover, we report for the first time the existence of length variability in SLT2 alleles of strains with a clinical origin. This is due to the expansion in the number of glutamine-encoding triplets in the microsatellite region coding for the polyglutamine (poly-Q) tract of this gene, which range from 12 to more than 38 repetitions. We suggest that this variability may influence biological features of the Slt2 protein, allowing it to adapt swiftly in order to survive in unusual environments. Copyright (c) 2010 John Wiley & Sons, Ltd.

Individual variability in clinical effect and tolerability of opioid analgesics - Importance of drug interactions and pharmacogenetics.

PubMed

Solhaug, Vigdis; Molden, Espen

2017-10-01

As pain is often a comorbid condition, many patients use opioid analgesics in combination with several other drugs. This implies a generally increased risk of drug interactions, which along with inherent pharmacogenetic variability and other factors may cause differences in therapeutic response of opioids. To provide an overview of interactions and pharmacogenetic variability of relevance for individual differences in effect and tolerability of opioid analgesics, which physicians and other healthcare professionals should be aware of in clinical practice. The article was based on unsystematic searches in PubMed to identify literature highlighting the clinical impact of drug interactions and pharmacogenetics as sources of variable response of opioid analgesics. Cytochrome P450 (CYP)-mediated metabolism is an important process for both clinically relevant interactions and pharmacogenetic variability of several opioids. Concomitant use of CYP inhibitors (e.g. paroxetine, fluoxetine and bupropion) or inducers (e.g. carbamazepine, phenobarbital and phenytoin) could counteract the clinical effect or trigger side effects of analgesics in the same manner as genetically determined differences in CYP2D6-mediated metabolism of many opioids. Moreover, combination treatment with drugs that inhibit or induce P-glycoprotein (ABCB1), a blood-brain barrier efflux transporter, may alter the amount ('dose') of opioids distributed to the brain. At the pharmacodynamic level, it is crucial to be aware of the potential risk of interaction causing serotonergic syndrome when combining opioids and serotonergic drugs, in particular antidepressants inhibiting serotonin reuptake (SSRIs and SNRIs). Regarding pharmacogenetics at the receptor level of pain treatment, the knowledge is currently scarce, but an allelic variant of the μ1 opioid receptor (OPRM1) gene has been associated with higher dosage requirement to achieve analgesia. Drug interactions and pharmacogenetic differences may lead to

Clinical Application and Pharmacodynamic Monitoring of Apixaban in a Patient with End-Stage Renal Disease Requiring Chronic Hemodialysis.

PubMed

Kufel, Wesley D; Zayac, Adam S; Lehmann, David F; Miller, Christopher D

2016-11-01

Despite prescribing guidance, limited data exist to describe the use of apixaban in patients with end-stage renal disease (ESRD) requiring hemodialysis (HD). Current apixaban dosing recommendations for this patient population are based largely on a single-dose pharmacokinetic study of eight patients. We describe the clinical application and pharmacodynamic monitoring of apixaban in a 62-year-old 156-kg African-American woman with nonvalvular atrial fibrillation and ESRD requiring hemodialysis who developed calciphylaxis while receiving warfarin therapy. Based on a multidisciplinary clinical judgment decision due to concern for drug accumulation after multiple doses in patients with ESRD receiving HD, she was anticoagulated with apixaban 2.5 mg twice/day, as opposed to 5 mg twice/day as recommended by the package insert. Antifactor Xa monitoring was used, and resultant peak and trough apixaban concentrations were above the upper limit of detection for our clinical laboratory (more than 2.00 IU/ml). On day 7 of her hospitalization, the patient developed gastrointestinal bleeding, and apixaban was discontinued; no further clinical signs of bleeding occurred during her subsequent hospitalization course. Use of the Naranjo Adverse Drug Reaction Probability Scale indicated a probable relationship (score of 6) between apixaban exposure and the manifestation of gastrointestinal bleeding. The patient ultimately died 44 days after the acute bleeding event; however, coagulation concerns were not implicated in the patient's death. To our knowledge, this is the first case report that describes apixaban use and associated antifactor Xa monitoring in a patient with ESRD receiving HD, and it provides concern for current apixaban dosing recommendations in this patient population. Further pharmacokinetic and clinical data are likely necessary to better characterize apixaban use in these patients to optimize safety and efficacy. © 2016 Pharmacotherapy Publications, Inc.

Carbon dioxide production during cardiopulmonary bypass: pathophysiology, measure and clinical relevance.

PubMed

Ranucci, Marco; Carboni, Giovanni; Cotza, Mauro; de Somer, Filip

2017-01-01

Carbon dioxide production during cardiopulmonary bypass derives from both the aerobic metabolism and the buffering of lactic acid produced by tissues under anaerobic conditions. Therefore, carbon dioxide removal monitoring is an important measure of the adequacy of perfusion and oxygen delivery. However, routine monitoring of carbon dioxide removal is not widely applied. The present article reviews the main physiological and pathophysiological sources of carbon dioxide, the available techniques to assess carbon dioxide production and removal and the clinically relevant applications of carbon dioxide-related variables as markers of the adequacy of perfusion during cardiopulmonary bypass.

Identifying novel phenotypes of acute heart failure using cluster analysis of clinical variables.

PubMed

Horiuchi, Yu; Tanimoto, Shuzou; Latif, A H M Mahbub; Urayama, Kevin Y; Aoki, Jiro; Yahagi, Kazuyuki; Okuno, Taishi; Sato, Yu; Tanaka, Tetsu; Koseki, Keita; Komiyama, Kota; Nakajima, Hiroyoshi; Hara, Kazuhiro; Tanabe, Kengo

2018-07-01

Acute heart failure (AHF) is a heterogeneous disease caused by various cardiovascular (CV) pathophysiology and multiple non-CV comorbidities. We aimed to identify clinically important subgroups to improve our understanding of the pathophysiology of AHF and inform clinical decision-making. We evaluated detailed clinical data of 345 consecutive AHF patients using non-hierarchical cluster analysis of 77 variables, including age, sex, HF etiology, comorbidities, physical findings, laboratory data, electrocardiogram, echocardiogram and treatment during hospitalization. Cox proportional hazards regression analysis was performed to estimate the association between the clusters and clinical outcomes. Three clusters were identified. Cluster 1 (n=108) represented "vascular failure". This cluster had the highest average systolic blood pressure at admission and lung congestion with type 2 respiratory failure. Cluster 2 (n=89) represented "cardiac and renal failure". They had the lowest ejection fraction (EF) and worst renal function. Cluster 3 (n=148) comprised mostly older patients and had the highest prevalence of atrial fibrillation and preserved EF. Death or HF hospitalization within 12-month occurred in 23% of Cluster 1, 36% of Cluster 2 and 36% of Cluster 3 (p=0.034). Compared with Cluster 1, risk of death or HF hospitalization was 1.74 (95% CI, 1.03-2.95, p=0.037) for Cluster 2 and 1.82 (95% CI, 1.13-2.93, p=0.014) for Cluster 3. Cluster analysis may be effective in producing clinically relevant categories of AHF, and may suggest underlying pathophysiology and potential utility in predicting clinical outcomes. Copyright © 2018 Elsevier B.V. All rights reserved.

Diabetic Foot Disease, Self-Care and Clinical Monitoring in Adults with Type 2 Diabetes: The Alberta's Caring for Diabetes (ABCD) Cohort Study.

PubMed

Al Sayah, Fatima; Soprovich, Allison; Qiu, Weiyu; Edwards, Alun L; Johnson, Jeffrey A

2015-10-01

To examine the prevalence and predictors of foot disease, self-care and clinical monitoring in adults with type 2 diabetes in Alberta, Canada. Baseline data from a prospective cohort of adults with type 2 diabetes were used. Assessment of foot disease included self-reported peripheral neuropathy, peripheral vasculopathy, foot or leg ulcer/infection or gangrene/amputation. Foot self-care was assessed using the Summary of Diabetes Self-Care Activities, and clinical monitoring using patients' reports of having feet checked for lesions or sensory loss. The mean age of respondents (N=2040) was 64 (SD 10.7) years; 45% were female, and 91% were Caucasian. Peripheral neuropathy was reported by 18% of the respondents, peripheral vasculopathy by 28%, ulcer/infection by 6% and gangrene/amputation by 1.4%. Only 14% of respondents performed foot self-care behaviours ≥6 days per week, and only 41% and 34% had their feet clinically checked for lesions or sensory loss, respectively. Predictors of foot disease included longer duration of diabetes, smoking, depressive symptoms, low self-efficacy and a history of cardiovascular diseases. Predictors of good self-care included older age, female sex, longer duration of diabetes and no report of hyperlipidemia. Predictors of clinical monitoring included female sex, current smoking, residing in urban areas, longer duration of diabetes, and histories of heart disease or hyperlipidemia. Peripheral neuropathy and vasculopathy were the most common reported foot problems in this population. Foot self-care is generally infrequent, and clinical monitoring is performed for less than half of these patients, with significant variations by patient demographics and clinical presentation. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

Variability of creatinine measurements in clinical laboratories: results from the CRIC study.

PubMed

Joffe, Marshall; Hsu, Chi-yuan; Feldman, Harold I; Weir, Matthew; Landis, J R; Hamm, L Lee

2010-01-01

Estimating equations using serum creatinine (SCr) are often used to assess glomerular filtration rate (GFR). Such creatinine (Cr)-based formulae may produce biased estimates of GFR when using Cr measurements that have not been calibrated to reference laboratories. In this paper, we sought to examine the degree of this variation in Cr assays in several laboratories associated with academic medical centers affiliated with the Chronic Renal Insufficiency Cohort (CRIC) Study; to consider how best to correct for this variation, and to quantify the impact of such corrections on eligibility for participation in CRIC. Variability of Cr is of particular concern in the conduct of CRIC, a large multicenter study of subjects with chronic renal disease, because eligibility for the study depends on Cr-based assessment of GFR. A library of 5 large volume plasma specimens from apheresis patients was assembled, representing levels of plasma Cr from 0.8 to 2.4 mg/dl. Samples from this library were used for measurement of Cr at each of the 14 CRIC laboratories repetitively over time. We used graphical displays and linear regression methods to examine the variability in Cr, and used linear regression to develop calibration equations. We also examined the impact of the various calibration equations on the proportion of subjects screened as potential participants who were actually eligible for the study. There was substantial variability in Cr assays across laboratories and over time. We developed calibration equations for each laboratory; these equations varied substantially among laboratories and somewhat over time in some laboratories. The laboratory site contributed the most to variability (51% of the variance unexplained by the specimen) and variation with time accounted for another 15%. In some laboratories, calibration equations resulted in differences in eligibility for CRIC of as much as 20%. The substantial variability in SCr assays across laboratories necessitates calibration

Scrub typhus in South India: clinical and laboratory manifestations, genetic variability, and outcome.

PubMed

Varghese, George M; Janardhanan, Jeshina; Trowbridge, Paul; Peter, John V; Prakash, John A J; Sathyendra, Sowmya; Thomas, Kurien; David, Thambu S; Kavitha, M L; Abraham, Ooriapadickal C; Mathai, Dilip

2013-11-01

This study sought to document the clinical and laboratory manifestations, genetic variability, and outcomes of scrub typhus, an often severe infection caused by Orientia tsutsugamushi, in South India. Patients admitted to a large teaching hospital with IgM ELISA-confirmed scrub typhus were evaluated. Clinical examination with a thorough search for an eschar, laboratory testing, chest X-ray, and outcome were documented and analyzed. Additionally, a 410-bp region of the 56-kDa type-specific antigen gene of O. tsutsugamushi was sequenced and compared with isolates from other regions of Asia. Most of the 154 patients evaluated presented with fever and non-specific symptoms. An eschar was found in 86 (55%) patients. Mild hepatic involvement was seen in most, with other organ involvement including respiratory, cardiovascular, and renal. Multi-organ dysfunction was noted in 59 (38.3%), and the fatality rate was 7.8%. Hypotension requiring vasoactive agents was found to be an independent predictor of mortality (p<0.001). The phylogeny of 26 samples showed 17 (65%) clustering with the Kato-like group and eight (31%) with the Karp-like group. The presentation of scrub typhus can be variable, often non-specific, but with potentially severe multi-organ dysfunction. Prompt recognition is key to specific treatment and good outcomes. Further study of the circulating strains is essential for the development of a successful vaccine and sensitive point-of-care testing. Copyright © 2013 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Clinical significance of automatic warning function of cardiac remote monitoring systems in preventing acute cardiac episodes

PubMed Central

Chen, Shou-Qiang; Xing, Shan-Shan; Gao, Hai-Qing

2014-01-01

Objective: In addition to ambulatory Holter electrocardiographic recording and transtelephonic electrocardiographic monitoring (TTM), a cardiac remote monitoring system can provide an automatic warning function through the general packet radio service (GPRS) network, enabling earlier diagnosis, treatment and improved outcome of cardiac diseases. The purpose of this study was to estimate its clinical significance in preventing acute cardiac episodes. Methods: Using 2 leads (V1 and V5 leads) and the automatic warning mode, 7160 patients were tested with a cardiac remote monitoring system from October 2004 to September 2007. If malignant arrhythmias or obvious ST-T changes appeared in the electrocardiogram records was automatically transferred to the monitoring center, the patient and his family members were informed, and the corresponding precautionary or therapeutic measures were implemented immediately. Results: In our study, 274 cases of malignant arrhythmia, including sinus standstill and ventricular tachycardia, and 43 cases of obvious ST-segment elevation were detected and treated. Because of early detection, there was no death or deformity. Conclusions: A cardiac remote monitoring system providing an automatic warning function can play an important role in preventing acute cardiac episodes. PMID:25674124

Maximizing the clinical utility of antimüllerian hormone testing in women's health

PubMed Central

Leader, Benjamin; Baker, Valerie L.

2014-01-01

Purpose of review To provide an update on the latest clinical applications of serum antimüllerian hormone (AMH) testing with practical approaches to mitigate the impact of significant variability in AMH results. Recent findings Recent studies continue to demonstrate that AMH is the best single serum test for ovarian response management with, at most, a weak-to-moderate age-independent association with live-birth rate and time to conception. Data confirm serum AMH levels improve menopause prediction, monitoring of ovarian damage, and identification of women at risk for several ovary-related disorders such as polycystic ovary syndrome and premature or primary ovarian insufficiency. However, it is now recognized that serum AMH results can have dramatic variability due to common, biologic fluctuations within some individuals, use of hormonal contraceptives or other medications, certain surgical procedures, specimen treatment, assay changes, and laboratory calibration differences. Practical guidelines are provided to minimize the impact of variability in AMH results and maximize the accuracy of clinical decision-making. Summary AMH is an ovarian biomarker of central importance which improves the clinical management of women's health. However, with the simultaneous rapid expansion of AMH clinical applications and recognition of variability in AMH results, consensus regarding the clinical cutpoints is increasingly difficult. Therefore, a careful approach to AMH measurement and interpretation in clinical care is essential. PMID:24978853

Mean Levels and Variability in Affect, Diabetes Self-Care Behaviors, and Continuously Monitored Glucose: A Daily Study of Latinos With Type 2 Diabetes.

PubMed

Wagner, Julie; Armeli, Stephen; Tennen, Howard; Bermudez-Millan, Angela; Wolpert, Howard; Pérez-Escamilla, Rafael

2017-09-01

This study investigated between- and within-person associations among mean levels and variability in affect, diabetes self-care behaviors, and continuously monitored glucose in Latinos with type 2 diabetes. Fifty participants (M [SD] age = 57.8 [11.7] years, 74% women, mean [SD] glycosylated hemoglobin A1c = 8.3% [1.5%]) wore a "blinded" continuous glucose monitor for 7 days, and they responded to twice daily automated phone surveys regarding positive affect, negative affect, and self-care behaviors. Higher mean levels of NA were associated with higher mean glucose (r = .30), greater percent hyperglycemia (r = .34) and greater percentage of out-of-range glucose (r = .34). Higher NA variability was also related to higher mean glucose (r = .34), greater percent of hyperglycemia (r = .44) and greater percentage of out-of-range glucose (r = .43). Higher positive affect variability was related to lower percentage of hypoglycemia (r = -.33). Higher mean levels of self-care behaviors were related to lower glucose variability (r = -.35). Finally, higher self-care behavior variability was related to greater percentage of hyperglycemia (r = .31) and greater percentage of out-of-range glucose (r = -.28). In multilevel regression models, within-person increases from mean levels of self-care were associated with lower mean levels of glucose (b = -7.4, 95% confidence interval [CI] = -12.8 to -1.9), lower percentage of hyperglycemia (b = -0.04, 95% CI = -0.07 to -0.01), and higher percentage of hypoglycemia (b = 0.02, 95% CI = 0.01 to 0.03) in the subsequent 10-hour period. Near-to-real time sampling documented associations of glucose with affect and diabetes self-care that are not detectable with traditional measures.

Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.

PubMed

Dallas, Michael J

2008-01-01

Upon termination of a clinical trial that uses interim evaluations to determine whether the trial can be stopped, a proper statistical analysis must account for the interim evaluations. For example, in a group-sequential design where the efficacy of a treatment regimen is evaluated at interim stages, and the opportunity to stop the trial based on positive efficacy findings exists, the terminal p-value, point estimate, and confidence limits of the outcome of interest must be adjusted to eliminate bias. While it is standard practice to adjust terminal statistical analyses due to opportunities to stop for "positive" findings, adjusting due to opportunities to stop for "negative" findings is also important. Stopping rules for negative findings are particularly useful when monitoring a specific rare serious adverse event in trials designed to show safety with respect to the event. In these settings, establishing conservative stopping rules are appropriate, and therefore accounting for the interim monitoring can have a substantial effect on the final results. Here I present a method to account for interim safety monitoring and illustrate its usefulness. The method is demonstrated to have advantages over methodology that does not account for interim monitoring.

Intra-Gene DNA Methylation Variability Is a Clinically Independent Prognostic Marker in Women’s Cancers

PubMed Central

Bartlett, Thomas E.; Jones, Allison; Goode, Ellen L.; Fridley, Brooke L.; Cunningham, Julie M.; Berns, Els M. J. J.; Wik, Elisabeth; Salvesen, Helga B.; Davidson, Ben; Trope, Claes G.; Lambrechts, Sandrina; Vergote, Ignace; Widschwendter, Martin

2015-01-01

We introduce a novel per-gene measure of intra-gene DNA methylation variability (IGV) based on the Illumina Infinium HumanMethylation450 platform, which is prognostic independently of well-known predictors of clinical outcome. Using IGV, we derive a robust gene-panel prognostic signature for ovarian cancer (OC, n = 221), which validates in two independent data sets from Mayo Clinic (n = 198) and TCGA (n = 358), with significance of p = 0.004 in both sets. The OC prognostic signature gene-panel is comprised of four gene groups, which represent distinct biological processes. We show the IGV measurements of these gene groups are most likely a reflection of a mixture of intra-tumour heterogeneity and transcription factor (TF) binding/activity. IGV can be used to predict clinical outcome in patients individually, providing a surrogate read-out of hard-to-measure disease processes. PMID:26629914

Executive function impairments in fibromyalgia syndrome: Relevance of clinical variables and body mass index

PubMed Central

2018-01-01

Background Several investigations suggest the presence of deterioration of executive function in fibromyalgia syndrome (FMS). The study quantified executive functions in patients with FMS. A wide array of functions was assessed, including updating, shifting and inhibition, as well as decision making and mental planning. Moreover, clinical variables were investigated as possible mediators of executive dysfunction, including pain severity, psychiatric comorbidity, medication and body mass index (BMI). Methods Fifty-two FMS patients and 32 healthy controls completed a battery of 14 neuropsychological tests. Clinical interviews were conducted and the McGill Pain Questionnaire, Beck Depression Inventory, State-Trait Anxiety Inventory, Fatigue Severity Scale and Oviedo Quality of Sleep Questionnaire were presented. Results Patients performed poorer than controls on the Letter Number Sequencing, Arithmetic and Similarities subtests of the Wechsler Adult Intelligence Scale, the Spatial Span subtest of the Wechsler Memory Scale, an N-back task, a verbal fluency task, the Ruff Figural Fluency Test, the Inhibition score of the Stroop Test, the Inhibition and Shifting scores of the Five Digits Test, the Key Search Test and the Zoo Map Task. Moreover, patients exhibited less steep learning curves on the Iowa Gambling Task. Among clinical variables, BMI and pain severity explained the largest proportion of performance variance. Conclusions This study demonstrated impairments in executive functions of updating, shifting inhibition, decision making and planning in FMS. While the mediating role of pain in cognitive impairments in FMS had been previously established, the influence of BMI is a novel finding. Overweight and obesity should be considered by FMS researchers, and in the treatment of the condition. PMID:29694417

Clinical Applications of Near-infrared Diffuse Correlation Spectroscopy and Tomography for Tissue Blood Flow Monitoring and Imaging

PubMed Central

Shang, Yu; Li, Ting; Yu, Guoqiang

2017-01-01

Blood flow is one such available observable promoting a wealth of physiological insight both individually and in combination with other metrics. Near-infrared diffuse correlation spectroscopy (DCS) and, to a lesser extent, diffuse correlation tomography (DCT), have increasingly received interest over the past decade as noninvasive methods for tissue blood flow measurements and imaging. DCS/DCT offers several attractive features for tissue blood flow measurements/imaging such as noninvasiveness, portability, high temporal resolution, and relatively large penetration depth (up to several centimeters). This review first introduces the basic principle and instrumentation of DCS/DCT, followed by presenting clinical application examples of DCS/DCT for the diagnosis and therapeutic monitoring of diseases in a variety of organs/tissues including brain, skeletal muscle, and tumor. Clinical study results demonstrate technical versatility of DCS/DCT in providing important information for disease diagnosis and intervention monitoring. PMID:28199219

Undertaking clinical audit, with reference to a Prescribing Observatory for Mental Health audit of lithium monitoring.

PubMed

Paton, Carol; Barnes, Thomas R E

2014-06-01

Audit is an important tool for quality improvement. The collection of data on clinical performance against evidence-based and clinically relevant standards, which are considered by clinicians to be realistic in routine practice, can usefully prompt reflective practice and the implementation of change. Evidence of participation in clinical audit is required to achieve intended learning outcomes for trainees in psychiatry and revalidation for those who are members of the Royal College of Psychiatrists. This article addresses some of the practical steps involved in conducting an audit project, and, to illustrate key points, draws on lessons learnt from a national, audit-based, quality improvement programme of lithium prescribing and monitoring conducted through the Prescribing Observatory for Mental Health.

The application of simple metrics in the assessment of glycaemic variability.

PubMed

Monnier, L; Colette, C; Owens, D R

2018-03-06

The assessment of glycaemic variability (GV) remains a subject of debate with many indices proposed to represent either short- (acute glucose fluctuations) or long-term GV (variations of HbA 1c ). For the assessment of short-term within-day GV, the coefficient of variation for glucose (%CV) defined as the standard deviation adjusted on the 24-h mean glucose concentration is easy to perform and with a threshold of 36%, recently adopted by the international consensus on use of continuous glucose monitoring, separating stable from labile glycaemic states. More complex metrics such as the Low Blood Glucose Index (LBGI) or High Blood Glucose Index (HBGI) allow the risk of hypo or hyperglycaemic episodes, respectively to be assessed although in clinical practice its application is limited due to the need for more complex computation. This also applies to other indices of short-term intraday GV including the mean amplitude of glycemic excursions (MAGE), Shlichtkrull's M-value and CONGA. GV is important clinically as exaggerated glucose fluctuations are associated with an enhanced risk of adverse cardiovascular outcomes due primarily to hypoglycaemia. In contrast, there is at present no compelling evidence that elevated short-term GV is an independent risk factor of microvascular complications of diabetes. Concerning long-term GV there are numerous studies supporting its association with an enhanced risk of cardiovascular events. However, this association raises the question as to whether the impact of long-term variability is not simply the consequence of repeated exposure to short-term GV or ambient chronic hyperglycaemia. The renewed emphasis on glucose monitoring with the introduction of continuous glucose monitoring technologies can benefit from the introduction and application of simple metrics for describing GV along with supporting recommendations. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Circulating tumor cells in clinical research and monitoring patients with colorectal cancer

PubMed Central

Burz, Claudia; Pop, Vlad-Vasile; Buiga, Rares; Daniel, Sur; Samasca, Gabriel; Aldea, Cornel; Lupan, Iulia

2018-01-01

Colorectal cancer remains a frequent disease to which screening and target therapy exist, but despite this is still marked by a high mortality rate. Even though radical surgery may be performed in many cases, patients relapse with metastatic disease. Circulating tumor cells were incriminated for tumor recurrence, that's why vigorous research started on their field. Owning prognostic and predictive value, it was revealed their usefulness in disease monitoring. Moreover, they may serve as liquid biopsies for genetic tests in cases where tissue biopsy is contraindicated or cannot be performed. In spite of these advantages, they were not included in clinical guidelines, despite CellSearch and many other detection methods were developed to ease the identification of circulating tumor cells. This review highlights the implication of circulating tumor cells in metastasis cascade, intrinsic tumor cells mechanisms and correlations with clinical parameters along with their utility for medical practice and detection techniques. PMID:29849961

Monitoring surgical and medical outcomes: the Bernoulli cumulative SUM chart. A novel application to assess clinical interventions

PubMed Central

Leandro, G; Rolando, N; Gallus, G; Rolles, K; Burroughs, A

2005-01-01

Background: Monitoring clinical interventions is an increasing requirement in current clinical practice. The standard CUSUM (cumulative sum) charts are used for this purpose. However, they are difficult to use in terms of identifying the point at which outcomes begin to be outside recommended limits. Objective: To assess the Bernoulli CUSUM chart that permits not only a 100% inspection rate, but also the setting of average expected outcomes, maximum deviations from these, and false positive rates for the alarm signal to trigger. Methods: As a working example this study used 674 consecutive first liver transplant recipients. The expected one year mortality set at 24% from the European Liver Transplant Registry average. A standard CUSUM was compared with Bernoulli CUSUM: the control value mortality was therefore 24%, maximum accepted mortality 30%, and average number of observations to signal was 500—that is, likelihood of false positive alarm was 1:500. Results: The standard CUSUM showed an initial descending curve (nadir at patient 215) then progressively ascended indicating better performance. The Bernoulli CUSUM gave three alarm signals initially, with easily recognised breaks in the curve. There were no alarms signals after patient 143 indicating satisfactory performance within the criteria set. Conclusions: The Bernoulli CUSUM is more easily interpretable graphically and is more suitable for monitoring outcomes than the standard CUSUM chart. It only requires three parameters to be set to monitor any clinical intervention: the average expected outcome, the maximum deviation from this, and the rate of false positive alarm triggers. PMID:16210461

Influence of carbon monoxide poisoning on the fetal heart monitor tracing: a report of 3 cases.

PubMed

Towers, Craig V; Corcoran, Vincent A

2009-03-01

The diagnosis of carbon monoxide poisoning in the third trimester of pregnancy requires an index of suspicion, and the appearance of the fetal heart monitor tracing may help in this regard. Three cases of third-trimester acute carbon monoxide poisoning occurred. In each pregnancy, the fetal heart monitor tracing on admission was correlated with the maternal carboxyhemoglobin level, and how the pattern changed following the institution of therapy was analyzed. In all 3 cases, the initial fetal heart rate pattern demonstrated decreased variability with an elevated baseline and an absence of accelerations and decelerations. Within 45-90 minutes of treatment onset, the baseline fetal heart rate dropped by 20-40 beats per minute, the variability became moderate, and accelerations occurred. Absent accelerations with minimal variability, if caused by uteroplacental insufficiency, are usually preceded by recurrent decelerations. Absent accelerations with minimal variability in the absence of recurrent decelerations may suggest another cause, of which carbon monoxide intoxication can be added to the differential, especially since this disorder often has nonspecific clinical symptoms.

An evaluation of the effectiveness of a risk-based monitoring approach implemented with clinical trials involving implantable cardiac medical devices.

PubMed

Diani, Christopher A; Rock, Angie; Moll, Phil

2017-12-01

Background Risk-based monitoring is a concept endorsed by the Food and Drug Administration to improve clinical trial data quality by focusing monitoring efforts on critical data elements and higher risk investigator sites. BIOTRONIK approached this by implementing a comprehensive strategy that assesses risk and data quality through a combination of operational controls and data surveillance. This publication demonstrates the effectiveness of a data-driven risk assessment methodology when used in conjunction with a tailored monitoring plan. Methods We developed a data-driven risk assessment system to rank 133 investigator sites comprising 3442 subjects and identify those sites that pose a potential risk to the integrity of data collected in implantable cardiac device clinical trials. This included identification of specific risk factors and a weighted scoring mechanism. We conducted trend analyses for risk assessment data collected over 1 year to assess the overall impact of our data surveillance process combined with other operational monitoring efforts. Results Trending analyses of key risk factors revealed an improvement in the quality of data collected during the observation period. The three risk factors follow-up compliance rate, unavailability of critical data, and noncompliance rate correspond closely with Food and Drug Administration's risk-based monitoring guidance document. Among these three risk factors, 100% (12/12) of quantiles analyzed showed an increase in data quality. Of these, 67% (8/12) of the improving trends in worst performing quantiles had p-values less than 0.05, and 17% (2/12) had p-values between 0.05 and 0.06. Among the poorest performing site quantiles, there was a statistically significant decrease in subject follow-up noncompliance rates, protocol noncompliance rates, and incidence of missing critical data. Conclusion One year after implementation of a comprehensive strategy for risk-based monitoring, including a data-driven risk

Technical pre-analytical effects on the clinical biochemistry of Atlantic salmon (Salmo salar L.).

PubMed

Braceland, M; Houston, K; Ashby, A; Matthews, C; Haining, H; Rodger, H; Eckersall, P D

2017-01-01

Clinical biochemistry has long been utilized in human and veterinary medicine as a vital diagnostic tool, but despite occasional studies showing its usefulness in monitoring health status in Atlantic salmon (Salmo salar L.), it has not yet been widely utilized within the aquaculture industry. This is due, in part, to a lack of an agreed protocol for collection and processing of blood prior to analysis. Moreover, while the analytical phase of clinical biochemistry is well controlled, there is a growing understanding that technical pre-analytical variables can influence analyte concentrations or activities. In addition, post-analytical interpretation of treatment effects is variable in the literature, thus making the true effect of sample treatment hard to evaluate. Therefore, a number of pre-analytical treatments have been investigated to examine their effect on analyte concentrations and activities. In addition, reference ranges for salmon plasma biochemical analytes have been established to inform veterinary practitioners and the aquaculture industry of the importance of clinical biochemistry in health and disease monitoring. Furthermore, a standardized protocol for blood collection has been proposed. © 2016 The Authors Journal of Fish Diseases Published by John Wiley & Sons Ltd.

Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support.

PubMed

Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria

2018-01-01

This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collated data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data.

Clinical pharmacology in Russia-historical development and current state.

PubMed

Zagorodnikova Goryachkina, Ksenia; Burbello, Aleksandra; Sychev, Dmitry; Frolov, Maxim; Kukes, Vladimir; Petrov, Vladimir

2015-02-01

Clinical pharmacology in Russia has long history and is currently active, but rather unrecognized internationally. It is governmentally approved as a teaching/scientific specialty since 1983 and as a medical specialty since 1997. Courses of clinical pharmacology are included in the undergraduate curricula in the 5th and/or 6th year of education at all medical schools in the Russian Federation. Postgraduate education includes initial specialization in internal medicine with further residency in clinical pharmacology. Governmental legislation recommends that every healthcare institution has either a department or a single position of clinical pharmacologist. Major routine duties include information about and monitoring of medication use, consultations in difficult clinical situations, pharmacogenetic counseling, therapeutic drug monitoring, pharmacovigilance, and participation in drug and therapeutics (formulary) committees. There are official experts in clinical pharmacology in Russia responsible for coordinating relevant legislative issues. The chief expert clinical pharmacologist represents the discipline directly at the Ministry of Health. Research in clinical pharmacology in Russia is extensive and variable, but only some of it is published internationally. Russia is a participant of international societies of clinical pharmacology and therapeutics and collaboration is actively ongoing. There are still certain problems related to the development of the discipline in Russia-some healthcare institutions do not see the need for clinical pharmacology. However, the number of clinical pharmacologists in Russia is increasing as well as their role in physicians' education, national healthcare, and research.

Survival characteristics and prognostic variables of dogs with mitral regurgitation attributable to myxomatous valve disease.

PubMed

Borgarelli, M; Savarino, P; Crosara, S; Santilli, R A; Chiavegato, D; Poggi, M; Bellino, C; La Rosa, G; Zanatta, R; Haggstrom, J; Tarducci, A

2008-01-01

There are few studies evaluating the natural history and prognostic variables in chronic mitral valve disease (CMVI) in a heterogeneous population of dogs. To estimate survival and prognostic value of clinical and echocardiographic variables in dogs with CMVI of varying severity. Five hundred and fifty-eight dogs belonging to 36 breeds were studied. Dogs were included after clinical examination and echocardiography. Long-term outcome was assessed by telephone interview with the owner. The mean follow-up time was 22.7 +/- 13.6 months, and the median survival time was 19.5 +/- 13.2 months. In univariate analysis, age>8 years, syncope, HR>140 bpm, dyspnea, arrhythmias, class of heart failure (International Small Animal Cardiac Health Council), furosemide therapy, end-systolic volume-index (ESV-I)>30 mL/m(2), left atrial to aortic root ratio (LA/Ao)>1.7, E wave transmitral peak velocity (Emax)>1.2 m/s, and bilateral mitral valve leaflet engagement were associated with survival time when all causes of death were included. For the cardiac-related deaths, all the previous variables except dyspnea and EDV-I>100 mL/m(2) were significantly associated with survival time. Significant variables in multivariate analysis (all causes of death) were syncope, LA/Ao>1.7 m/s, and Emax>1.2 m/s. For cardiac-related death, the only significant variable was LA/Ao>1.7. Mild CMVI is a relatively benign condition in dogs. However, some clinical variables can identify dogs at a higher risk of death; these variables might be useful to identify individuals that need more frequent monitoring or therapeutic intervention.

Clinical variables associated with suicide attempts in schizophrenia before and after the first episode.

PubMed

Togay, Bilge; Noyan, Handan; Tasdelen, Rumeysa; Ucok, Alp

2015-09-30

The aim of this study was to investigate variables associated with suicide attempts in schizophrenia before and after the first episode. We evaluated history of past sucide attempts, clinical symptoms, level of functioning and cognitive performances of 172 patients with first-episode schizophrenia at first admission. Information was collected regarding clinical symptom severity, treatment compliance, and suicide attempts during the follow-up. We found that 16.5% of the patients attempted suicide before admission, and 6.2% of them attempted suicide during the follow-up. The patients who had attempted suicide before admission were mostly women, and more likely to be hospitalized in first year of follow up. BPRS-depression subscale score at admission and alcohol/substance use appeared as independent variables that found associated with suicide attempts prior to admission in logistic regression analysis. The patients who attempted suicide during the follow-up had significantly higher BPRS-depression subcale scores at sixth months of follow-up. Treatment compliance during the first 6 months and duration of remission was lower in this group. Our findings suggest that longer duration of first hospital treatment, the presence of depressive symptoms, and nonadherence to treatment in early phases of follow up after FES are predictors of suicide attempts. On the other hand, keeping remission during the follow-up protects against suicide attempts. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Development of variable pathlength UV-vis spectroscopy combined with partial-least-squares regression for wastewater chemical oxygen demand (COD) monitoring.

PubMed

Chen, Baisheng; Wu, Huanan; Li, Sam Fong Yau

2014-03-01

To overcome the challenging task to select an appropriate pathlength for wastewater chemical oxygen demand (COD) monitoring with high accuracy by UV-vis spectroscopy in wastewater treatment process, a variable pathlength approach combined with partial-least squares regression (PLSR) was developed in this study. Two new strategies were proposed to extract relevant information of UV-vis spectral data from variable pathlength measurements. The first strategy was by data fusion with two data fusion levels: low-level data fusion (LLDF) and mid-level data fusion (MLDF). Predictive accuracy was found to improve, indicated by the lower root-mean-square errors of prediction (RMSEP) compared with those obtained for single pathlength measurements. Both fusion levels were found to deliver very robust PLSR models with residual predictive deviations (RPD) greater than 3 (i.e. 3.22 and 3.29, respectively). The second strategy involved calculating the slopes of absorbance against pathlength at each wavelength to generate slope-derived spectra. Without the requirement to select the optimal pathlength, the predictive accuracy (RMSEP) was improved by 20-43% as compared to single pathlength spectroscopy. Comparing to nine-factor models from fusion strategy, the PLSR model from slope-derived spectroscopy was found to be more parsimonious with only five factors and more robust with residual predictive deviation (RPD) of 3.72. It also offered excellent correlation of predicted and measured COD values with R(2) of 0.936. In sum, variable pathlength spectroscopy with the two proposed data analysis strategies proved to be successful in enhancing prediction performance of COD in wastewater and showed high potential to be applied in on-line water quality monitoring. Copyright © 2013 Elsevier B.V. All rights reserved.

A systematic review of near-infrared spectroscopy in flap monitoring: Current basic and clinical evidence and prospects.

PubMed

Kagaya, Yu; Miyamoto, Shimpei

2018-02-01

Near-infrared spectroscopy (NIRS) has been reported to be a reliable non-invasive modality for free flap monitoring; however, the history of its application in flap monitoring is short, and there is no definite consensus regarding its use at present. The aim of this review is to clarify the evidence related to post-operative flap monitoring using NIRS and examine its appropriateness and usability. The PubMed and Web of Science databases were searched using the strings "flap monitoring AND near-infrared spectroscopy" and "flap monitoring AND tissue oxygen saturation," with a study period from inception to December 31, 2016. Two authors independently extracted articles and assessed the quality of the studies. Articles related to NIRS for flap perfusion monitoring were classified and selected regardless of study type. A total of 15 clinical studies and 8 animal studies were identified and reviewed. The evidence and information on various aspects of NIRS flap monitoring were summarized. The overall flap success rate was 99.5%, and the flap salvage rate was 91.1%, when measuring StO 2 at intervals of every 2 h or sooner. Single StO 2 monitoring was able to detect vascular compromise with 99.1% sensitivity and 99.9% specificity, and earlier than other monitoring methods, but additional Hb concentration monitoring was useful for avoiding false negatives and differentiating arterial and venous occlusion. NIRS can be used for flap monitoring and displays high accuracy in various situations; however, further studies are needed to take full advantage of the potential of NIRS. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

In Silico Evaluation of Pharmacokinetic Optimization for Antimitogram-Based Clinical Trials.

PubMed

Haviari, Skerdi; You, Benoît; Tod, Michel

2018-04-01

Antimitograms are prototype in vitro tests for evaluating chemotherapeutic efficacy using patient-derived primary cancer cells. These tests might help optimize treatment from a pharmacodynamic standpoint by guiding treatment selection. However, they are technically challenging and require refinements and trials to demonstrate benefit to be widely used. In this study, we performed simulations aimed at exploring how to validate antimitograms and how to complement them by pharmacokinetic optimization. A generic model of advanced cancer, including pharmacokinetic-pharmacodynamic monitoring, was used to link dosing schedules with progression-free survival (PFS), as built from previously validated modules. This model was used to explore different possible situations in terms of pharmacokinetic variability, pharmacodynamic variability, and antimitogram performance. The model recapitulated tumor dynamics and standalone therapeutic drug monitoring efficacy consistent with published clinical results. Simulations showed that combining pharmacokinetic and pharmacodynamic optimization should increase PFS in a synergistic fashion. Simulated data were then used to compute required clinical trial sizes, which were 30% to 90% smaller when pharmacokinetic optimization was added to pharmacodynamic optimization. This improvement was observed even when pharmacokinetic optimization alone exhibited only modest benefit. Overall, our work illustrates the synergy derived from combining antimitograms with therapeutic drug monitoring, permitting a disproportionate reduction of the trial size required to prove a benefit on PFS. Accordingly, we suggest that strategies with benefits too small for standalone clinical trials could be validated in combination in a similar manner. Significance: This work offers a method to reduce the number of patients needed for a clinical trial to prove the hypothesized benefit of a drug to progression-free survival, possibly easing opportunities to evaluate

Idiopathic granulomatous mastitis: a heterogeneous disease with variable clinical presentation.

PubMed