Monitoring for neuroprotection. New technologies for the new millennium

NASA Technical Reports Server (NTRS)

Andrews, R. J.

2001-01-01

Monitoring for neuroprotection, like surgery, has placed on emphasis on minimal or non-invasiveness. Monitoring of parameters that truly reflect the degree of injury to the nervous system is another goal. Thus, two themes for the coming decade in neuromonitoring will be: (1) less-invasive monitoring; and (2) parameters that more closely reflect the etiological factors in ischemic or other neuroinjury. In this paper, we review neuromonitoring techniques and devices that can be used readily in the operating room or intensive care unit setting. Those that require transport of the patient to a special facility (e.g., for computed tomography or magnetic resonance imaging/spectroscopy) and those that have been in standard practice for neuromonitoring (e.g., electrophysiological monitoring--EEG, evoked potentials) are not considered. The two techniques considered in detail are (1) continuous multiparameter local brain tissue monitoring with microprobes, and (2) non-invasive continuous local brain tissue oxygenation monitoring by near infrared spectroscopy. Both techniques have been cleared by the Food and Drug Administration (FDA) for clinical use. The rationale for their use, the nature of the devices, and clinical results to date are reviewed. It is expected that both techniques will gain wide acceptance during the coming decade; further advances in neuromonitoring that can be expected further into the twenty-first century are also discussed.

Use of sensors in the treatment and follow-up of patients with diabetes mellitus.

PubMed

Torres, Isabel; Baena, Maria G; Cayon, Manuel; Ortego-Rojo, Jose; Aguilar-Diosdado, Manuel

2010-01-01

Glucose control is the cornerstone of Diabetes Mellitus (DM) treatment. Although self-regulation using capillary glycemia (SRCG) still remains the best procedure in clinical practice, continuous glucose monitoring systems (CGM) offer the possibility of continuous and dynamic assessment of interstitial glucose concentration. CGM systems have the potential to improve glycemic control while decreasing the incidence of hypoglycemia but the efficiency, compared with SRCG, is still debated. CGM systems have the greatest potential value in patients with hypoglycemic unawareness and in controlling daily fluctuations in blood glucose. The implementation of continuous monitoring in the standard clinical setting has not yet been established but a new generation of open and close loop subcutaneous insulin infusion devices are emerging making insulin treatment and glycemic control more reliable.

Use of Sensors in the Treatment and Follow-up of Patients with Diabetes Mellitus

PubMed Central

Torres, Isabel; Baena, Maria G.; Cayon, Manuel; Ortego-Rojo, Jose; Aguilar-Diosdado, Manuel

2010-01-01

Glucose control is the cornerstone of Diabetes Mellitus (DM) treatment. Although self-regulation using capillary glycemia (SRCG) still remains the best procedure in clinical practice, continuous glucose monitoring systems (CGM) offer the possibility of continuous and dynamic assessment of interstitial glucose concentration. CGM systems have the potential to improve glycemic control while decreasing the incidence of hypoglycemia but the efficiency, compared with SRCG, is still debated. CGM systems have the greatest potential value in patients with hypoglycemic unawareness and in controlling daily fluctuations in blood glucose. The implementation of continuous monitoring in the standard clinical setting has not yet been established but a new generation of open and close loop subcutaneous insulin infusion devices are emerging making insulin treatment and glycemic control more reliable. PMID:22163609

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 monitoring clinic, 31 patients (45%) were identified as having a therapy-related problem with their oral chemotherapy regimen on a gross measure for safety and appropriateness of medication management during the course of eight months follow-up between September 2014 and April 2015. In addition, the clinic helped to reestablish care for three patients (4.4%) who were lost to follow-up. The clinic identified 12 patients (17.6%) non-adherent to their prescribed regimen in some degree, where patients were suspected to miss doses due to delay in refilling prescriptions at least three days later than the expected date. However, these patients denied non-adherence. Among them, six patients (8.8%) were truly non-adherent. These patients stated that they had missed at least one day of therapy or were not taking the medication as prescribed. Medication regimen errors were discovered for five patients, accounting for a 7.3% medication-related error rate. Finally, seven patients (10.3%) were found to have an adverse reaction attributed to their oral chemotherapy. Two of them (2.9%) developed severe adverse reactions (Grade 3 and 4), which required hospitalization or immediate dose de-escalation. Conclusions The pilot clinic was able to identify current deficiencies and gaps in our practice settings for managing oral chemotherapy in a Veterans population. The oral chemotherapy monitoring clinic played a proactive role to identify preventable medication errors, monitor medication therapy, improve adherence, manage adverse drug reactions and re-establish care for patients who were lost to follow-up. The results suggest that close monitoring and follow-up of patients on oral chemotherapy is crucial to achieve therapeutic goals, improve patient safety and adherence, and to reduce drug adverse events and health care cost.

[Technological innovations in the treatment of type 1 diabetes in pediatrics].

PubMed

Tubiana-Rufi, Nadia

2016-01-01

Insulin pumps, continuous glucose monitoring sensors and algorithms for managing the doses of insulin necessary to control blood sugar levels within target values: more and more research is being carried out into "closed loop" systems. The artificial pancreas is today at the stage of clinical trials in adults and children. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Abacavir/Dolutegravir/Lamivudine (Triumeq)-Induced Liver Toxicity in a Human Immunodeficiency Virus-Infected Patient.

PubMed

Christensen, Erin S; Jain, Rupali; Roxby, Alison C

2017-01-01

Drug-induced liver injury related to Triumeq (abacavir/lamivudine/dolutegravir) has not been reported in clinical trials. We report a case of hepatotoxicity related to Triumeq exposure in a human immunodeficiency virus-infected patient. Clinicians should remain aware of the risk for acute and late-onset hepatitis with these agents. Close monitoring is recommended.

Availability of color calibration for consistent color display in medical images and optimization of reference brightness for clinical use

NASA Astrophysics Data System (ADS)

Iwai, Daiki; Suganami, Haruka; Hosoba, Minoru; Ohno, Kazuko; Emoto, Yutaka; Tabata, Yoshito; Matsui, Norihisa

2013-03-01

Color image consistency has not been accomplished yet except the Digital Imaging and Communication in Medicine (DICOM) Supplement 100 for implementing a color reproduction pipeline and device independent color spaces. Thus, most healthcare enterprises could not check monitor degradation routinely. To ensure color consistency in medical color imaging, monitor color calibration should be introduced. Using simple color calibration device . chromaticity of colors including typical color (Red, Green, Blue, Green and White) are measured as device independent profile connection space value called u'v' before and after calibration. In addition, clinical color images are displayed and visual differences are observed. In color calibration, monitor brightness level has to be set to quite lower value 80 cd/m2 according to sRGB standard. As Maximum brightness of most color monitors available currently for medical use have much higher brightness than 80 cd/m2, it is not seemed to be appropriate to use 80 cd/m2 level for calibration. Therefore, we propose that new brightness standard should be introduced while maintaining the color representation in clinical use. To evaluate effects of brightness to chromaticity experimentally, brightness level is changed in two monitors from 80 to 270cd/m2 and chromaticity value are compared with each brightness levels. As a result, there are no significant differences in chromaticity diagram when brightness levels are changed. In conclusion, chromaticity is close to theoretical value after color calibration. Moreover, chromaticity isn't moved when brightness is changed. The results indicate optimized reference brightness level for clinical use could be set at high brightness in current monitors .

Management of craniomandibular disorders. Part 1: A craniocervical dysfunction index.

PubMed

Wallace, C; Klineberg, I J

1993-01-01

A craniocervical dysfunction index has been developed (based on the Helkimo Dysfunction Index) to comprehensively assess craniocervical dysfunction and to objectively monitor the management of patients who present with these clinical problems. The close functional interrelationship of temporomandibular joints, jaw muscles, and cervical joints and muscles is reviewed, and a mechanism is proposed to explain dysfunctional relationships between these structures. This is the first of three papers stemming from a clinical study that investigated craniomandibular disorders and assessed the effect of routine dental management on craniomandibular and craniocervical dysfunction.

Functionality of empirical model-based predictive analytics for the early detection of hemodynamic instabilty.

PubMed

Summers, Richard L; Pipke, Matt; Wegerich, Stephan; Conkright, Gary; Isom, Kristen C

2014-01-01

Background. Monitoring cardiovascular hemodynamics in the modern clinical setting is a major challenge. Increasing amounts of physiologic data must be analyzed and interpreted in the context of the individual patient’s pathology and inherent biologic variability. Certain data-driven analytical methods are currently being explored for smart monitoring of data streams from patients as a first tier automated detection system for clinical deterioration. As a prelude to human clinical trials, an empirical multivariate machine learning method called Similarity-Based Modeling (“SBM”), was tested in an In Silico experiment using data generated with the aid of a detailed computer simulator of human physiology (Quantitative Circulatory Physiology or “QCP”) which contains complex control systems with realistic integrated feedback loops. Methods. SBM is a kernel-based, multivariate machine learning method that that uses monitored clinical information to generate an empirical model of a patient’s physiologic state. This platform allows for the use of predictive analytic techniques to identify early changes in a patient’s condition that are indicative of a state of deterioration or instability. The integrity of the technique was tested through an In Silico experiment using QCP in which the output of computer simulations of a slowly evolving cardiac tamponade resulted in progressive state of cardiovascular decompensation. Simulator outputs for the variables under consideration were generated at a 2-min data rate (0.083Hz) with the tamponade introduced at a point 420 minutes into the simulation sequence. The functionality of the SBM predictive analytics methodology to identify clinical deterioration was compared to the thresholds used by conventional monitoring methods. Results. The SBM modeling method was found to closely track the normal physiologic variation as simulated by QCP. With the slow development of the tamponade, the SBM model are seen to disagree while the simulated biosignals in the early stages of physiologic deterioration and while the variables are still within normal ranges. Thus, the SBM system was found to identify pathophysiologic conditions in a timeframe that would not have been detected in a usual clinical monitoring scenario. Conclusion. In this study the functionality of a multivariate machine learning predictive methodology that that incorporates commonly monitored clinical information was tested using a computer model of human physiology. SBM and predictive analytics were able to differentiate a state of decompensation while the monitored variables were still within normal clinical ranges. This finding suggests that the SBM could provide for early identification of a clinical deterioration using predictive analytic techniques. predictive analytics, hemodynamic, monitoring.

Comparisons of different measurements for monitoring diabetic cats treated with porcine insulin zinc suspension.

PubMed

Martin, G J; Rand, J S

2007-07-14

Clinical measurements, including a subjective clinical score and water intake, and biochemical measurements, including blood glucose, fructosamine, beta-hydroxybutyrate, cholesterol, triglycerides, triglycerides corrected for free glycerol, glycerol and urine glucose were compared for monitoring diabetic cats treated with porcine insulin zinc suspension. The data were grouped by subjective clinical score and the sensitivity of each measurement in differentiating the grouped data was assessed. None of the measurements was able to differentiate between the ranked clinical score groups, but two-hourly measurements of blood glucose over 24 hours, water intake, urine glucose and fructosamine were useful in differentiating cats that subjectively had the water and food consumption and general appearance of a normal cat from cats in which the signs of diabetes were less well controlled. Measurements of plasma lipids were not well correlated with the other measurements. The measurements that were most closely correlated with apparently perfect clinical control were the J index, water intake and maximum and mean blood glucose concentrations. In practice, water intake, maximum blood glucose concentration, mean blood glucose concentration and urine glucose would be the most useful indicators of clinical control in diabetic cats treated with porcine insulin zinc suspension.

Abacavir/Dolutegravir/Lamivudine (Triumeq)–Induced Liver Toxicity in a Human Immunodeficiency Virus–Infected Patient

PubMed Central

Jain, Rupali; Roxby, Alison C.

2017-01-01

Abstract Drug-induced liver injury related to Triumeq (abacavir/lamivudine/dolutegravir) has not been reported in clinical trials. We report a case of hepatotoxicity related to Triumeq exposure in a human immunodeficiency virus–infected patient. Clinicians should remain aware of the risk for acute and late-onset hepatitis with these agents. Close monitoring is recommended. PMID:28748198

Practice, supervision, consultancy and appraisal: a continuum of learning.

PubMed Central

Launer, John

2003-01-01

I examine four different kinds of learning conversation: reflective practice, clinical supervision, work consultancy and performance appraisal. I propose that there is a close and reciprocal relationship between these kinds of conversation, and that they represent different aspects of a unified field, or continuum. I argue that appraisal should be seen as part of this learning continuum rather than as form of monitoring. PMID:14601347

Assessing performance of closed-loop insulin delivery systems by continuous glucose monitoring: drawbacks and way forward.

PubMed

Hovorka, Roman; Nodale, Marianna; Haidar, Ahmad; Wilinska, Malgorzata E

2013-01-01

We investigated whether continuous glucose monitoring (CGM) levels can accurately assess glycemic control while directing closed-loop insulin delivery. Data were analyzed retrospectively from 33 subjects with type 1 diabetes who underwent closed-loop and conventional pump therapy on two separate nights. Glycemic control was evaluated by reference plasma glucose and contrasted against three methods based on Navigator (Abbott Diabetes Care, Alameda, CA) CGM levels. Glucose mean and variability were estimated by unmodified CGM levels with acceptable clinical accuracy. Time when glucose was in target range was overestimated by CGM during closed-loop nights (CGM vs. plasma glucose median [interquartile range], 86% [65-97%] vs. 75% [59-91%]; P=0.04) but not during conventional pump therapy (57% [32-72%] vs. 51% [29-68%]; P=0.82) providing comparable treatment effect (mean [SD], 28% [29%] vs. 23% [21%]; P=0.11). Using the CGM measurement error of 15% derived from plasma glucose-CGM pairs (n=4,254), stochastic interpretation of CGM gave unbiased estimate of time in target during both closed-loop (79% [62-86%] vs. 75% [59-91%]; P=0.24) and conventional pump therapy (54% [33-66%] vs. 51% [29-68%]; P=0.44). Treatment effect (23% [24%] vs. 23% [21%]; P=0.96) and time below target were accurately estimated by stochastic CGM. Recalibrating CGM using reference plasma glucose values taken at the start and end of overnight closed-loop was not superior to stochastic CGM. CGM is acceptable to estimate glucose mean and variability, but without adjustment it may overestimate benefit of closed-loop. Stochastic CGM provided unbiased estimate of time when glucose is in target and below target and may be acceptable for assessment of closed-loop in the outpatient setting.

A modular, closed-loop platform for intracranial stimulation in people with neurological disorders.

PubMed

Sarma, Anish A; Crocker, Britni; Cash, Sydney S; Truccolo, Wilson

2016-08-01

Neuromodulation systems based on electrical stimulation can be used to investigate, probe, and potentially treat a range of neurological disorders. The effects of ongoing neural state and dynamics on stimulation response, and of stimulation parameters on neural state, have broad implications for the development of closed-loop neuro-modulation approaches. We describe the development of a modular, low-latency platform for pre-clinical, closed-loop neuromodulation studies with human participants. We illustrate the uses of the platform in a stimulation case study with a person with epilepsy undergoing neuro-monitoring prior to resective surgery. We demonstrate the efficacy of the system by tracking interictal epileptiform discharges in the local field potential to trigger intracranial electrical stimulation, and show that the response to stimulation depends on the neural state.

Implementation science for ambulatory care safety: a novel method to develop context-sensitive interventions to reduce quality gaps in monitoring high-risk patients.

PubMed

McDonald, Kathryn M; Su, George; Lisker, Sarah; Patterson, Emily S; Sarkar, Urmimala

2017-06-24

Missed evidence-based monitoring in high-risk conditions (e.g., cancer) leads to delayed diagnosis. Current technological solutions fail to close this safety gap. In response, we aim to demonstrate a novel method to identify common vulnerabilities across clinics and generate attributes for context-flexible population-level monitoring solutions for widespread implementation to improve quality. Based on interviews with staff in otolaryngology, pulmonary, urology, breast, and gastroenterology clinics at a large urban publicly funded health system, we applied journey mapping to co-develop a visual representation of how patients are monitored for high-risk conditions. Using a National Academies framework and context-sensitivity theory, we identified common systems vulnerabilities and developed preliminary concepts for improving the robustness for monitoring patients with high-risk conditions ("design seeds" for potential solutions). Finally, we conducted a face validity and prioritization assessment of the design seeds with the original interviewees. We identified five high-risk situations for potentially consequential diagnostic delays arising from suboptimal patient monitoring. All situations related to detection of cancer (head and neck, lung, prostate, breast, and colorectal). With clinic participants we created 5 journey maps, each representing specialty clinic workflow directed at evidence-based monitoring. System vulnerabilities common to the different clinics included challenges with: data systems, communications handoffs, population-level tracking, and patient activities. Clinic staff ranked 13 design seeds (e.g., keep patient list up to date, use triggered notifications) addressing these vulnerabilities. Each design seed has unique evaluation criteria for the usefulness of potential solutions developed from the seed. We identified and ranked 13 design seeds that characterize situations that clinicians described 'wake them up at night', and thus could reduce their anxiety, save time, and improve monitoring of high-risk patients. We anticipate that the design seed approach promotes robust and context-sensitive solutions to safety and quality problems because it provides a human-centered link between the experienced problem and various solutions that can be tested for viability. The study also demonstrates a novel integration of industrial and human factors methods (journey mapping, process tracing and design seeds) linked to implementation theory for use in designing interventions that anticipate and reduce implementation challenges.

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.

Persistence of the same genetic type of Mycoplasma hyopneumoniae in a closed herd for at least two years.

PubMed

Rebaque, Florencia; Camacho, Pablo; Parada, Julián; Lucchesi, Paula; Ambrogi, Arnaldo; Tamiozzo, Pablo

2017-10-20

Two cross-sectional studies were carried out in 2013 and 2015 monitoring for Mycoplasma hyopneumoniae presence in a swine farm. In these studies, the genetic diversity of M. hyopneumoniae was assessed in clinical specimens using a Multiple Locus Variable-number tandem repeat Analysis (MLVA) targeting P97 R1, P146 R3 and H4 loci. The samples from August 2015 showed the MLVA profile prevalent in June 2013, therefore it can be concluded that a same genetic type of M. hyopneumoniae can persist for at least two years in a closed herd. In addition, the nested PCR reactions implemented in this study showed to be useful for MLVA typing in non-invasive clinical samples. Copyright © 2017 Asociación Argentina de Microbiología. Publicado por Elsevier España, S.L.U. All rights reserved.

[Chronic hypertension and pregnancy].

PubMed

Lecarpentier, Edouard; Tsatsaris, Vassili

2012-09-01

Hypertensive disorders in pregnancy are a leading cause of maternal and perinatal mortality and morbidity. The management of patients with chronic hypertension requires a multidisciplinary approach prior to conception, during pregnancy and post-partum. In the preconception period, fetotoxic agents should be discontinued. It is also essential to undertake a full cardiovascular examination which may, in some cases, question the possibility of pregnancy. During pregnancy, blood pressure should be monitored and controlled, but not necessarily returned to a normal value. Low blood pressure levels could indeed lead to placental hypoperfusion and fetal growth restriction. Close clinical, biological and ultrasound monitoring is recommended, even postpartum, since those patients are at higher risk for preeclampsia.

Selecting Treatments and Monitoring Outcomes: The Circle of Evidence-Based Practice and Client-Centered Care in Treating a Preschool Child Who Stutters

ERIC Educational Resources Information Center

Ratner, Nan Bernstein

2018-01-01

Purpose: The purpose of the present clinical forum is to compare how 2 clinicians might select among therapy options for a preschool-aged child who presents with stuttering close to onset. Method: I discuss approaches to full evaluation of the child's profile, advisement of evidence-based practice options open to the family, the need for…

The emergence of clinical resistance to tigecycline.

PubMed

Sun, Yan; Cai, Yun; Liu, Xu; Bai, Nan; Liang, Beibei; Wang, Rui

2013-02-01

Tigecycline (TIG) exhibits broad-spectrum activity against many Gram-positive and Gram-negative pathogens. However, clinical resistance has emerged recently and has been detected following treatment with TIG. This observation suggests that long-term monotherapy may carry a high risk for TIG resistance. TIG resistance is observed most frequently in Acinetobacter baumannii and Enterobacteriaceae, especially in multidrug-resistant strains. Resistance-nodulation-cell division (RND)-type transporters and other efflux pumps may be factors for decreased sensitivity to TIG. Therefore, TIG should be cautiously used in the clinic, and efflux-mediated resistance should be closely monitored in order to prolong the lifespan of this useful antibiotic. Copyright © 2012 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

Conflict of interest in biomedical research: a view from Europe.

PubMed

Salvi, Maurizio

2003-01-01

In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address CoI in the authorisation process of research and clinical protocols of biomedicine.

Study of model of anesthesia related adverse event by incident report at King Chulalongkorn Memorial Hospital.

PubMed

Narasethkamol, Arunchai; Charuluxananan, Somrat; Kyokong, Oranuch; Premsamran, Porntep; Kundej, Sarawut

2011-01-01

As a site of the Thai Anesthesia Incidents Monitoring Study (Thai AIMS), the authors continued data collection of incident reports to find out the frequency, clinical course, contributing factors, factors minimizing adverse events, and investigation of model appropriate for possible corrective strategies in a Thai university hospital. A standardized anesthesia incident report form that included close-end and open-end questions was provided to the attending anesthesia personnel of King Chulalongkorn Memorial Hospital between January I and December 31, 2007. They filled it on a voluntary and anonymous basis. Each incident report was reviewed by three reviewers. Any disagreement was discussed to achieve a consensus. One hundred sixty three incident reports were filled reporting 191 incidents. There were fewer male (44%) than female (56%) patients and they had an ASA physical status classification 1 (41%), 2 (43%), 3 (10%), 4 (4%) and 5 (2%). Surgical specialties that posed high risk of incidents were general, orthopedic, gynecological, otorhino-laryngological and urological surgery. Locations of incident were operating room (85%), ward (8%) and recovery room (2%). The common adverse incidents were oxygen desaturation (23%), arrhythmia needing treatment (14%), equipment malfunction (13%), drug error (9%), difficult intubation (6%), esophageal intubation (5%), cardiac arrest (5%), reintubation (4%), and endobronchial intubation (4%). Adverse events were detected by monitoring only (27%), by monitoring before clinical diagnosis (26%), by clinical diagnosis before monitoring (21%), and by clinical diagnosis only (26%). Incidents were considered to be from anesthesia related factor (73%), system factor (16%) and preventable (47%). Common factors related to incident were inexperience, lack of vigilance, haste, inappropriate decision, not comply with guidelines, and lack of equipment maintenance. Suggested corrective strategies were quality assurance activity, additional training, clinical practice guidelines, equipment maintenance, and improvement of supervision.

Management and prevention of refeeding syndrome in medical inpatients: An evidence-based and consensus-supported algorithm.

PubMed

Friedli, Natalie; Stanga, Zeno; Culkin, Alison; Crook, Martin; Laviano, Alessandro; Sobotka, Lubos; Kressig, Reto W; Kondrup, Jens; Mueller, Beat; Schuetz, Philipp

2018-03-01

Refeeding syndrome (RFS) can be a life-threatening metabolic condition after nutritional replenishment if not recognized early and treated adequately. There is a lack of evidence-based treatment and monitoring algorithm for daily clinical practice. The aim of the study was to propose an expert consensus guideline for RFS for the medical inpatient (not including anorexic patients) regarding risk factors, diagnostic criteria, and preventive and therapeutic measures based on a previous systematic literature search. Based on a recent qualitative systematic review on the topic, we developed clinically relevant recommendations as well as a treatment and monitoring algorithm for the clinical management of inpatients regarding RFS. With international experts, these recommendations were discussed and agreement with the recommendation was rated. Upon hospital admission, we recommend the use of specific screening criteria (i.e., low body mass index, large unintentional weight loss, little or no nutritional intake, history of alcohol or drug abuse) for risk assessment regarding the occurrence of RFS. According to the patient's individual risk for RFS, a careful start of nutritional therapy with a stepwise increase in energy and fluids goals and supplementation of electrolyte and vitamins, as well as close clinical monitoring, is recommended. We also propose criteria for the diagnosis of imminent and manifest RFS with practical treatment recommendations with adoption of the nutritional therapy. Based on the available evidence, we developed a practical algorithm for risk assessment, treatment, and monitoring of RFS in medical inpatients. In daily routine clinical care, this may help to optimize and standardize the management of this vulnerable patient population. We encourage future quality studies to further refine these recommendations. Copyright © 2017 Elsevier Inc. All rights reserved.

Crossing the quality chasm: the role of information technology departments.

PubMed

Weir, Charlene R; Hicken, Bret L; Rappaport, Hank Steven; Nebeker, Jonathan R

2006-01-01

Integrating information technology (IT) into medical settings is considered essential to transforming hospitals into 21st-century health care institutions. Yet the role of IT departments in maximizing the effectiveness of information systems is not well understood. This article reports a 3-round Delphi panel of Veterans Administration personnel experienced with provider order entry electronic systems. In round 1, 35 administrative, clinical, and IT personnel answered 10 open-ended questions about IT strategies and structures that best support successful transformation. In round 2, panelists rated item importance and ranked proposed strategies. In round 3, panelists received aggregate feedback and rerated the items. Four domains emerged from round 1: IT organization, IT performance monitoring, user-support activities, and core IT responsibilities (eg, computer security, training). In rounds 2 and 3, IT performance monitoring was rated the most important, closely followed by clinical support. Strategies associated with each domain are identified and discussed.

Intraoperative neurophysiological monitoring of the cortico-spinal tract in image-guided mini-invasive neurosurgery.

PubMed

Cordella, Roberto; Acerbi, Francesco; Broggi, Morgan; Vailati, Davide; Nazzi, Vittoria; Schiariti, Marco; Tringali, Giovanni; Ferroli, Paolo; Franzini, Angelo; Broggi, Giovanni

2013-06-01

To evaluate the role of intraoperative neurophysiological monitoring in image-guided mini-invasive neurosurgery. Twenty-one patients were operated under general anaesthesia with the aid of multimodal intraoperative neurophysiological monitoring to remove supratentorials tumors closely related to the cortico-spinal tract. Pre-operative assessment included fMRI scans and tractography that were uploaded into the intraoperative neuro-navigation system. Monitoring consisted in simultaneously recording EEG, electrocorticography, transcranial and direct motor evoked potentials (tMEP and dMEP), somatosensory evoked potentials and subcortical stimulation during the whole procedures. The recording of all the electrophysiological signals was possible in all procedures. SSEP guided the positioning of the strip electrode over the motor cortex (N20 phase inversion) that was used to evoke dMEP and monitor the lower limb motor responses; subcortical stimulation to unveil the spatial relationship between the tumors and motor fibers. Four patients had transient worsening of the symptoms, but only two had a long-term worsening, although not severe, of the pre-op clinical status. Intraoperative neurophysiology has a great value in mini-invasive neurosurgery, especially because the motor cortex is not exposed, consequently it cannot be directly mapped. This report describes a valuable scheme making use of as many electrophysiological signals as possible to constantly monitor the motor functions. A useful method to monitor motor functions in mini-invasive neurosurgery was described. Copyright © 2012 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Are vital signs indicative for bacteremia in newborns?

PubMed

Yapıcıoğlu, Hacer; Özlü, Ferda; Sertdemir, Yaşar

2015-01-01

Neonatal systemic infection is a leading cause of morbidity and mortality both in industrialized and developing countries. The aim of this prospective study was to evaluate if vital signs had a predictive power in neonatal sepsis as an early marker. This study was designed as a matched case-control study. Vital signs were monitorized prior to infection in newborns that had healthcare-associated blood stream infection (BSI). Maximum and minimum values of the vital signs (blood pressure, heart rate, respiratory rate and temperature) of the babies at rest were recorded from the nurse observation charts five days prior to clinical sepsis and compared with vital signs of healthy, age-matched babies. Maximum mean heart rates, respiratory rates and systolic blood pressure levels of the patients in BSI group were significantly higher than the control group in the past three days prior to clinical deterioration. Monitoring vital signs closely might be helpful in a newborn infant to define a BSI. In future, a respiratory and blood pressure predictive monitoring system such as heart rate variability index may be developed for newborn patients with sepsis.

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.

Cognitive Factors and Residual Speech Errors: Basic Science, Translational Research, and Some Clinical Frameworks.

PubMed

Eaton, Catherine Torrington

2015-11-01

This article explores the theoretical and empirical relationships between cognitive factors and residual speech errors (RSEs). Definitions of relevant cognitive domains are provided, as well as examples of formal and informal tasks that may be appropriate in assessment. Although studies to date have been limited in number and scope, basic research suggests that cognitive flexibility, short- and long-term memory, and self-monitoring may be areas of weakness in this population. Preliminary evidence has not supported a relationship between inhibitory control, attention, and RSEs; however, further studies that control variables such as language ability and temperament are warranted. Previous translational research has examined the effects of self-monitoring training on residual speech errors. Although results have been mixed, some findings suggest that children with RSEs may benefit from the inclusion of this training. The article closes with a discussion of clinical frameworks that target cognitive skills, including self-monitoring and attention, as a means of facilitating speech sound change. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Monitoring and control of atmosphere in a closed environment

NASA Technical Reports Server (NTRS)

Humphries, R.; Perry, J.

1991-01-01

Applications requiring new technologies for atmosphere monitoring and control in the closed environment and their principal functions aboard the Space Station Freedom are described. Oxygen loop closure, involving the conversion of carbon dioxide to oxygen; carbon dioxide reduction and removal; and monitoring of atmospheric contamination are discussed. The Trace Contaminant Monitor, the Major Constituent Analyzer, the Carbon Dioxide Monitor, and the Particulate Counter Monitor are discussed.

Serial Liver Stiffness Measurements and Monitoring of Liver-Transplanted Patients in a Real-Life Clinical Practice

PubMed Central

Rinaldi, Luca; Valente, Giovanna; Piai, Guido

2016-01-01

Background Liver transplanted patients need close surveillance for early signs of graft disease. Objectives Transient elastography can safely be repeated over time, offering serial liver stiffness measurement values. Serial stiffness measurements were compared to single baseline stiffness measurements in predicting the appearance of liver-related clinical events and guiding subsequent clinical decisions. Methods One hundred and sixty liver transplanted patients were observed for three years in our real-life practice. Results Liver stiffness measurements were stable in 75% of patients, decreased in 4% of patients, and increased in 21% of patients. The pattern of increased stiffness measurements was associated with both HCV-RNA positive status and the presence of an active biliary complication of liver transplantation and was more predictive of a clinically significant event resulting from any disease of the transplanted liver when compared to a stable pattern or to a single liver stiffness measurement. The procedures that were consequently performed were often diagnostic for unexpected situations, both in HCV-RNA positive and HCV-RNA negative patients. Conclusions The pattern of longitudinally increased liver stiffness measurements efficiently supported clinical decisions for individualized management strategies. Repeated transient elastography in real-life clinical practice appears to have a practical role in monitoring liver transplanted patients. PMID:28123442

Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended-Release Once-Daily Tacrolimus Tablets.

PubMed

Philosophe, Benjamin; Leca, Nicolae; West-Thielke, Patricia M; Horwedel, Timothy; Culkin-Gemmell, Christine; Kistler, Kristin; Stevens, Daniel R

2018-02-20

The majority of United States kidney transplant patients are treated with tacrolimus, a drug effective in preventing graft rejection, but with a narrow therapeutic range, necessitating close monitoring to avoid increased risks of transplant rejection or toxicity if the tacrolimus concentration is too low or too high, respectively. The trough drug concentration tests are time sensitive; patients treated on a twice-daily basis have blood draws exactly 12 hours after their previous dose. The schedule's rigidity causes problems for both patients and health care providers. Novel once-daily tacrolimus formulations such as LCPT (an extended-release tablet by Veloxis Pharmaceuticals, Inc., Cary, North Carolina) have allowed for blood draws on a once-daily basis; however, even that schedule can be restrictive. Results from tests taken either before or after that 24-hour target time may be discarded, or worse, may lead to inappropriate dose changes. Data from ASTCOFF, a phase 3B pharmacokinetic clinical trial (NCT02339246), demonstrated that the unique pharmacokinetic curve of LCPT may allow for a therapeutic monitoring window that extends for 3 hours before or after the 24-hour monitoring target. Furthermore, important tools to help clinicians interpret these levels, such as formulas to estimate the 24-hour trough level if an alternative monitoring time is used, were constructed from these data. These study results give treating clinicians access to data that allow them to safely use and monitor LCPT in their patients and expand the body of evidence surrounding differentiation and practical application of the novel LCPT tacrolimus formulation. © 2018, The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics.

PubMed

Koethe, John R; Westfall, Andrew O; Luhanga, Dora K; Clark, Gina M; Goldman, Jason D; Mulenga, Priscilla L; Cantrell, Ronald A; Chi, Benjamin H; Zulu, Isaac; Saag, Michael S; Stringer, Jeffrey S A

2010-03-12

The benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree). Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months. From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites. A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings. Clinicaltrials.gov NCT00929604.

Noninvasive assessment of hemodynamic and brain metabolism parameters following closed head injury in a mouse model by comparative diffuse optical reflectance approaches.

PubMed

Abookasis, David; Volkov, Boris; Shochat, Ariel; Kofman, Itamar

2016-04-01

Optical techniques have gained substantial interest over the past four decades for biomedical imaging due to their unique advantages, which may suggest their use as alternatives to conventional methodologies. Several optical techniques have been successfully adapted to clinical practice and biomedical research to monitor tissue structure and function in both humans and animal models. This paper reviews the analysis of the optical properties of brain tissue in the wavelength range between 500 and 1000 nm by three different diffuse optical reflectance methods: spatially modulated illumination, orthogonal diffuse light spectroscopy, and dual-wavelength laser speckle imaging, to monitor changes in brain tissue morphology, chromophore content, and metabolism following head injury. After induction of closed head injury upon anesthetized mice by weight-drop method, significant changes in hemoglobin oxygen saturation, blood flow, and metabolism were readily detectible by all three optical setups, up to 1 h post-trauma. Furthermore, the experimental results clearly demonstrate the feasibility and reliability of the three methodologies, and the differences between the system performances and capabilities are also discussed. The long-term goal of this line of study is to combine these optical systems to study brain pathophysiology in high spatiotemporal resolution using additional models of brain trauma. Such combined use of complementary algorithms should fill the gaps in each system's capabilities, toward the development of a noninvasive, quantitative tool to expand our knowledge of the principles underlying brain function following trauma, and to monitor the efficacy of therapeutic interventions in the clinic.

Noninvasive assessment of hemodynamic and brain metabolism parameters following closed head injury in a mouse model by comparative diffuse optical reflectance approaches

PubMed Central

Abookasis, David; Volkov, Boris; Shochat, Ariel; Kofman, Itamar

2016-01-01

Abstract. Optical techniques have gained substantial interest over the past four decades for biomedical imaging due to their unique advantages, which may suggest their use as alternatives to conventional methodologies. Several optical techniques have been successfully adapted to clinical practice and biomedical research to monitor tissue structure and function in both humans and animal models. This paper reviews the analysis of the optical properties of brain tissue in the wavelength range between 500 and 1000 nm by three different diffuse optical reflectance methods: spatially modulated illumination, orthogonal diffuse light spectroscopy, and dual-wavelength laser speckle imaging, to monitor changes in brain tissue morphology, chromophore content, and metabolism following head injury. After induction of closed head injury upon anesthetized mice by weight-drop method, significant changes in hemoglobin oxygen saturation, blood flow, and metabolism were readily detectible by all three optical setups, up to 1 h post-trauma. Furthermore, the experimental results clearly demonstrate the feasibility and reliability of the three methodologies, and the differences between the system performances and capabilities are also discussed. The long-term goal of this line of study is to combine these optical systems to study brain pathophysiology in high spatiotemporal resolution using additional models of brain trauma. Such combined use of complementary algorithms should fill the gaps in each system’s capabilities, toward the development of a noninvasive, quantitative tool to expand our knowledge of the principles underlying brain function following trauma, and to monitor the efficacy of therapeutic interventions in the clinic. PMID:27175372

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.

[How to improve the management of heart failure by the general practitioner?].

PubMed

Vandenbossche, J L

2012-09-01

Current treatment of heart failure remains suboptimally implemented, leading to less favorable outcome. Readmission due to decompensation, remains frequent, in about 20% of patients at one month and 50% at six months. Precipitating factors of deterioration are known, including inappropriate drug interactions, and the early detection can be facilitated by simple clinical features (weight, heart rate, dyspnea) that can be confirmed by biomarkers (BNP, Nt-ProBNP). Medical treatment relies upon the proper use of drugs that have been demonstrated efficacious in the randomized clinical trials, and have been proposed in the international clinical guidelines. The basic principle of their titration consists on a gradual increase of the dosage, up to the target dosages, or maximal clinically tolerated dosages. Particular attention shall be paid to renal function and kaliemia, besides clinical parameters; close monitoring is mandatory along the treatment.

Serendipitous Discovery of Factor VII Deficiency and the Ensuing Dilemma.

PubMed

Umakanthan, Jayadev M; Dhakal, Prajwal; Gundabolu, Krishna; Koepsell, Scott A; Baljevic, Muhamed

2018-03-01

Congenital factor VII deficiency is a challenging disorder to manage, as it is associated with varied genotypes that do not clinically correlate with a bleeding phenotype. Individuals with severe factor VII deficiency (FVII: c <1%) might be asymptomatic, while patients with moderate deficiency (FVII: c level >5%) may experience severe hemorrhages. In modern medicine, due to extensive routine pre-operative laboratory testing, clinically asymptomatic patients without any bleeding history might be incidentally discovered, raising clinical dilemmas. Careful consideration of bleeding versus thrombosis risk has to be made in such cases, especially in the elderly. Clinical history of no prior bleeding complications may be a reassuring factor. Minimal required replacement dosing of recombinant activated factor VII can be given peri-operatively in such situations, with close monitoring.

Biomarkers for Early Detection of Clinically Relevant Prostate Cancer: A Multi-Institutional Validation Trial

DTIC Science & Technology

2015-10-01

Suzanne Kolb 12 Project Role: Project Coordinator Researcher Identifier (e.g. ORCID ID): N/A Nearest person month worked: 5 person months...Contribution to Project: Ms. Kolb works under the direction of Drs. Lin and Newcomb to fulfill daily fiscal and administrative functions of the...program. She monitors subaward budgets, provides logistical support. Ms. Kolb works closely with the PASS Deputy Director to maintain IRB files

Biomarkers for Early Detection of Clinically Relevant Prostate Cancer: A Multi-Institutional Validation Trial

DTIC Science & Technology

2015-10-01

Name: Suzanne Kolb 12 Project Role: Project Coordinator Researcher Identifier (e.g. ORCID ID): N/A Nearest person month worked: 5 person...months Contribution to Project: Ms. Kolb works under the direction of Drs. Lin and Newcomb to fulfill daily fiscal and administrative functions of the...program. She monitors subaward budgets, provides logistical support. Ms. Kolb works closely with the PASS Deputy Director to maintain IRB files

Critical care cardiology.

PubMed

Marks, S L; Abbott, J A

1998-11-01

Emergency management of the patient with cardiac disease is an important part of veterinary practice. Although the causes of cardiac disease may be diverse, the understanding of basic pathophysiology will enable the clinician to formulate a rational diagnostic and therapeutic plan. The veterinary clinician must be able to triage the emergency patient, assess the clinical condition, and provide appropriate therapy. Close monitoring of the critically ill patient is crucial to patient survival and will help tailor therapy.

Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial.

PubMed

Lilot, Marc; Bellon, Amandine; Gueugnon, Marine; Laplace, Marie-Christine; Baffeleuf, Bruno; Hacquard, Pauline; Barthomeuf, Felicie; Parent, Camille; Tran, Thomas; Soubirou, Jean-Luc; Robinson, Philip; Bouvet, Lionel; Vassal, Olivia; Lehot, Jean-Jacques; Piriou, Vincent

2018-01-27

An intraoperative automated closed-loop system for goal-directed fluid therapy has been successfully tested in silico, in vivo and in a clinical case-control matching. This trial compared intraoperative cardiac output (CO) in patients managed with this closed-loop system versus usual practice in an academic medical center. The closed-loop system was connected to a CO monitoring system and delivered automated colloid fluid boluses. Moderate to high-risk abdominal surgical patients were randomized either to the closed-loop or the manual group. Intraoperative final CO was the primary endpoint. Secondary endpoints were intraoperative overall mean cardiac index (CI), increase from initial to final CI, intraoperative fluid volume and postoperative outcomes. From January 2014 to November 2015, 46 patients were randomized. There was a lower initial CI (2.06 vs. 2.51 l min -1 m -2 , p = 0.042) in the closed-loop compared to the control group. No difference in final CO and in overall mean intraoperative CI was observed between groups. A significant relative increase from initial to final CI values was observed in the closed-loop but not the control group (+ 28.6%, p = 0.006 vs. + 1.2%, p = 0.843). No difference was found for intraoperative fluid management and postoperative outcomes between groups. There was no significant impact on the primary study endpoint, but this was found in a context of unexpected lower initial CI in the closed-loop group.Trial registry number ID-RCB/EudraCT: 2013-A00770-45. ClinicalTrials.gov Identifier NCT01950845, date of registration: 17 September 2013.

Optimization of the monitoring of landfill gas and leachate in closed methanogenic landfills.

PubMed

Jovanov, Dejan; Vujić, Bogdana; Vujić, Goran

2018-06-15

Monitoring of the gas and leachate parameters in a closed landfill is a long-term activity defined by national legislative worldwide. Serbian Waste Disposal Law defines the monitoring of a landfill at least 30 years after its closing, but the definition of the monitoring extent (number and type of parameters) is incomplete. In order to define and clear all the uncertainties, this research focuses on process of monitoring optimization, using the closed landfill in Zrenjanin, Serbia, as the experimental model. The aim of optimization was to find representative parameters which would define the physical, chemical and biological processes in the closed methanogenic landfill and to make this process less expensive. Research included development of the five monitoring models with different number of gas and leachate parameters and each model has been processed in open source software GeoGebra which is often used for solving optimization problems. The results of optimization process identified the most favorable monitoring model which fulfills all the defined criteria not only from the point of view of mathematical analyses, but also from the point of view of environment protection. The final outcome of this research - the minimal required parameters which should be included in the landfill monitoring are precisely defined. Copyright © 2017 Elsevier Ltd. All rights reserved.

Behavior Change Techniques Implemented in Electronic Lifestyle Activity Monitors: A Systematic Content Analysis

PubMed Central

Lewis, Zakkoyya H; Mayrsohn, Brian G; Rowland, Jennifer L

2014-01-01

Background Electronic activity monitors (such as those manufactured by Fitbit, Jawbone, and Nike) improve on standard pedometers by providing automated feedback and interactive behavior change tools via mobile device or personal computer. These monitors are commercially popular and show promise for use in public health interventions. However, little is known about the content of their feedback applications and how individual monitors may differ from one another. Objective The purpose of this study was to describe the behavior change techniques implemented in commercially available electronic activity monitors. Methods Electronic activity monitors (N=13) were systematically identified and tested by 3 trained coders for at least 1 week each. All monitors measured lifestyle physical activity and provided feedback via an app (computer or mobile). Coding was based on a hierarchical list of 93 behavior change techniques. Further coding of potentially effective techniques and adherence to theory-based recommendations were based on findings from meta-analyses and meta-regressions in the research literature. Results All monitors provided tools for self-monitoring, feedback, and environmental change by definition. The next most prevalent techniques (13 out of 13 monitors) were goal-setting and emphasizing discrepancy between current and goal behavior. Review of behavioral goals, social support, social comparison, prompts/cues, rewards, and a focus on past success were found in more than half of the systems. The monitors included a range of 5-10 of 14 total techniques identified from the research literature as potentially effective. Most of the monitors included goal-setting, self-monitoring, and feedback content that closely matched recommendations from social cognitive theory. Conclusions Electronic activity monitors contain a wide range of behavior change techniques typically used in clinical behavioral interventions. Thus, the monitors may represent a medium by which these interventions could be translated for widespread use. This technology has broad applications for use in clinical, public health, and rehabilitation settings. PMID:25131661

Behavior change techniques implemented in electronic lifestyle activity monitors: a systematic content analysis.

PubMed

Lyons, Elizabeth J; Lewis, Zakkoyya H; Mayrsohn, Brian G; Rowland, Jennifer L

2014-08-15

Electronic activity monitors (such as those manufactured by Fitbit, Jawbone, and Nike) improve on standard pedometers by providing automated feedback and interactive behavior change tools via mobile device or personal computer. These monitors are commercially popular and show promise for use in public health interventions. However, little is known about the content of their feedback applications and how individual monitors may differ from one another. The purpose of this study was to describe the behavior change techniques implemented in commercially available electronic activity monitors. Electronic activity monitors (N=13) were systematically identified and tested by 3 trained coders for at least 1 week each. All monitors measured lifestyle physical activity and provided feedback via an app (computer or mobile). Coding was based on a hierarchical list of 93 behavior change techniques. Further coding of potentially effective techniques and adherence to theory-based recommendations were based on findings from meta-analyses and meta-regressions in the research literature. All monitors provided tools for self-monitoring, feedback, and environmental change by definition. The next most prevalent techniques (13 out of 13 monitors) were goal-setting and emphasizing discrepancy between current and goal behavior. Review of behavioral goals, social support, social comparison, prompts/cues, rewards, and a focus on past success were found in more than half of the systems. The monitors included a range of 5-10 of 14 total techniques identified from the research literature as potentially effective. Most of the monitors included goal-setting, self-monitoring, and feedback content that closely matched recommendations from social cognitive theory. Electronic activity monitors contain a wide range of behavior change techniques typically used in clinical behavioral interventions. Thus, the monitors may represent a medium by which these interventions could be translated for widespread use. This technology has broad applications for use in clinical, public health, and rehabilitation settings.

Efficient Blood-Brain Barrier Opening in Primates with Neuronavigation-Guided Ultrasound and Real-Time Acoustic Mapping.

PubMed

Wu, Shih-Ying; Aurup, Christian; Sanchez, Carlos Sierra; Grondin, Julien; Zheng, Wenlan; Kamimura, Hermes; Ferrera, Vincent P; Konofagou, Elisa E

2018-05-22

Brain diseases including neurological disorders and tumors remain under treated due to the challenge to access the brain, and blood-brain barrier (BBB) restricting drug delivery which, also profoundly limits the development of pharmacological treatment. Focused ultrasound (FUS) with microbubbles is the sole method to open the BBB noninvasively, locally, and transiently and facilitate drug delivery, while translation to the clinic is challenging due to long procedure, targeting limitations, or invasiveness of current systems. In order to provide rapid, flexible yet precise applications, we have designed a noninvasive FUS and monitoring system with the protocol tested in monkeys (from in silico preplanning and simulation, real-time targeting and acoustic mapping, to post-treatment assessment). With a short procedure (30 min) similar to current clinical imaging duration or radiation therapy, the achieved targeting (both cerebral cortex and subcortical structures) and monitoring accuracy was close to the predicted 2-mm lower limit. This system would enable rapid clinical transcranial FUS applications outside of the MRI system without a stereotactic frame, thereby benefiting patients especially in the elderly population.

Home oxygen therapy: re-thinking the role of devices.

PubMed

Melani, Andrea S; Sestini, Piersante; Rottoli, Paola

2018-03-01

A range of devices are available for delivering and monitoring home oxygen therapy (HOT). Guidelines do not give indications for the choice of the delivery device but recommend the use of an ambulatory system in subjects on HOT whilst walking. Areas covered: We provide a clinical overview of HOT and review traditional and newer delivery and monitoring devices for HOT. Despite relevant technology advancements, clinicians, faced with many challenges when they prescribe oxygen therapy, often remain familiar to traditional devices and continuous flow delivery of oxygen. Some self-filling delivery-less devices could increase the users' level of independence with ecological advantage and, perhaps, reduced cost. Some newer portable oxygen concentrators are being available, but more work is needed to understand their performances in different diseases and clinical settings. Pulse oximetry has gained large diffusion worldwide and some models permit long-term monitoring. Some closed-loop portable monitoring devices are also able to adjust oxygen flow automatically in accordance with the different needs of everyday life. This might help to improve adherence and the practice of proper oxygen titration that has often been omitted because difficult to perform and time-consuming. Expert commentary: The prescribing physicians should know the characteristics of newer devices and use technological advancements to improve the practice of HOT.

Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas.

PubMed

Kovatchev, Boris P; Renard, Eric; Cobelli, Claudio; Zisser, Howard C; Keith-Hynes, Patrick; Anderson, Stacey M; Brown, Sue A; Chernavvsky, Daniel R; Breton, Marc D; Farret, Anne; Pelletier, Marie-Josée; Place, Jérôme; Bruttomesso, Daniela; Del Favero, Simone; Visentin, Roberto; Filippi, Alessio; Scotton, Rachele; Avogaro, Angelo; Doyle, Francis J

2013-07-01

To evaluate the feasibility of a wearable artificial pancreas system, the Diabetes Assistant (DiAs), which uses a smart phone as a closed-loop control platform. Twenty patients with type 1 diabetes were enrolled at the Universities of Padova, Montpellier, and Virginia and at Sansum Diabetes Research Institute. Each trial continued for 42 h. The United States studies were conducted entirely in outpatient setting (e.g., hotel or guest house); studies in Italy and France were hybrid hospital-hotel admissions. A continuous glucose monitoring/pump system (Dexcom Seven Plus/Omnipod) was placed on the subject and was connected to DiAs. The patient operated the system via the DiAs user interface in open-loop mode (first 14 h of study), switching to closed-loop for the remaining 28 h. Study personnel monitored remotely via 3G or WiFi connection to DiAs and were available on site for assistance. The total duration of proper system communication functioning was 807.5 h (274 h in open-loop and 533.5 h in closed-loop), which represented 97.7% of the total possible time from admission to discharge. This exceeded the predetermined primary end point of 80% system functionality. This study demonstrated that a contemporary smart phone is capable of running outpatient closed-loop control and introduced a prototype system (DiAs) for further investigation. Following this proof of concept, future steps should include equipping insulin pumps and sensors with wireless capabilities, as well as studies focusing on control efficacy and patient-oriented clinical outcomes.

Dynamic skin changes of acute radiation dermatitis revealed by in vivo reflectance confocal microscopy.

PubMed

Vano-Galvan, S; Fernandez-Lizarbe, E; Truchuelo, M; Diaz-Ley, B; Grillo, E; Sanchez, V; Ríos-Buceta, L; Paoli, J; Sancho, S; Montero, A; Hernanz, R; Ramos, A; Jaen, P; Gonzalez, S

2013-09-01

A better knowledge of the dynamic biological changes that the skin undergoes in response to ionizing radiation is advisable to improve the management of radiation dermatitis, allowing selection of patients needing treatment or close monitoring. To describe the evolution of the skin in response to ionizing radiation through the reflectance confocal microscopy (RCM) features of acute radiation dermatitis. In this prospective descriptive study, six women (median age, 55 years; range, 45-80 years) diagnosed with breast cancer in stages IA-IB undergoing adjuvant radiotherapy were included in the study through consecutive sampling. Clinical, dermoscopic and RCM evaluation of the skin were performed prior to treatment and on days 1, 15, 30 and 45 after radiotherapy. While clinical features of radiation dermatitis emerged after 30 days on average, histopathological changes were detectable by RCM after a mean time of 15 days. The main RCM features included initial appearance of spongiosis, exocytosis and inflammatory cells followed by the presence of dendritic-shaped cells, 'streaming-like figures', 'broken geographic papillae', epidermal architectural disarray, effacement of rete ridges, melanophages and, finally, hyperpigmentation of the basal layer. RCM may safely detect the dynamic biological changes that the skin undergoes in response to ionizing radiation, even before than clinical onset of acute radiation dermatitis. Therefore, RCM may be useful to make an early and non-invasive diagnosis of radiation dermatitis during radiotherapy, allowing an early selection of patients needing treatment or close monitoring and avoiding skin biopsies. © 2012 The Authors. Journal of the European Academy of Dermatology and Venereology © 2012 European Academy of Dermatology and Venereology.

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 <18 years. Thirteen of 256 women of reproductive age (5%) were pregnant. The country of passport issuance was known for 720 of the travelers. The majority of monitored travelers (478 [66%]) used a non-U.S. passport including 442 (61%) Liberian nationals. A total of 772 (99%) travelers were "low (but not zero)" risk; 11 (1%) were "some" risk. Among monitored travelers, 43 (5%) experienced illness symptoms; 29 (67%) had a symptom consistent with EVD. Two were tested for Ebola virus disease and had negative results. Most frequently reported symptoms were fever (20/43, 47%) and abdominal pain (12/43, 28%). During evaluation, 16 (37%) of 43 travelers reported their symptoms began prior to travel; chronic health conditions in 24 travelers including tumors/cancer, pregnancy, and orthopedic conditions were most common. Infectious causes in 19 travelers included upper respiratory infection, malaria, and gastrointestinal infections. Prior to 2014, no similar active monitoring program for travelers had been performed in Minnesota; assessment and management of symptomatic travelers was a new activity for MDH. Ensuring safe entrance into healthcare was particularly challenging for children, and pregnant women, as well as those without an established connection to healthcare. Unnecessary inpatient evaluations were successfully avoided by close clinical follow-up by phone. Before similar monitoring programs are considered in the future, careful thought must be given to necessary resources and the impact on affected populations, public health, and the healthcare system.

Gaining Control of Occupational Injury and Illness in the U.S. Navy Civilian Work Force

DTIC Science & Technology

1990-01-16

caring for the back. Also monitored by the supervisor is a work -hardening program developed by the clinic physical therapist and physician that... development of a work -hardening program for the returning injured employee to ensure a safe re-entry to the workplace. e. "Green Table" and Medical...physical therapist work closely in developing effective programs for the treatment of occupational injuries. Having an onsite physical therapist available

The Laboratory’s Role in Opioid Pain Medication Monitoring

PubMed Central

2012-01-01

Opioid analgesics are the most potent pain medications therefore they are often used for the treatment of chronic malignant and non-malignant pain. Their strong addictive potential requires close monitoring of patients on opioid therapy for possible non-compliance with prescriptions, for drug diversion, and for proof of avoidance of non-prescribed or illicit opioids. Monitoring can be performed by urine drug screens or qualitative or quantitative drug confirmation assays. Natural, semi-synthetic and synthetic opioids have dissimilar chemical structures and they undergo extensive metabolism. Phase one metabolic reactions of opioids can produce other opioids with similar structures to other, non-prescribed medications. Only detailed and concurrent analysis of parent drugs and metabolites can provide accurate clinical information regarding patient compliance. Traditional immunoassays, often used for urine drug screening, react with only a small number of opioids or only with a single medication and they exhibit variable cross reactivity with their phase two metabolites. Additionally the limit of detection of these immunoassays may not be sufficient for medical purposes, therefore clinical interpretation of immunoassay test results can be challenging. Recently liquid chromatography, mass spectrometry (LCMSMS) based assays have been adapted by many clinical laboratories. These LCMSMS tests can provide information about the presence of several opioids and their metabolites in a single sample at clinically meaningful detection limits, allowing accurate assessment of patient compliance. This review article will investigate in details the various opioids, their metabolism and the challenges the testing laboratories and ordering clinicians face. PMID:27683413

Clinical spectrum of impulse control disorders in Parkinson's disease.

PubMed

Weintraub, Daniel; David, Anthony S; Evans, Andrew H; Grant, Jon E; Stacy, Mark

2015-02-01

Impulse control disorders (ICDs), including compulsive gambling, buying, sexual behavior, and eating, are a serious and increasingly recognized psychiatric complication in Parkinson's disease (PD). Other impulsive-compulsive behaviors (ICBs) have been described in PD, including punding (stereotyped, repetitive, purposeless behaviors) and dopamine dysregulation syndrome (DDS; compulsive PD medication overuse). ICDs have been most closely related to the use of dopamine agonists (DAs), perhaps more so at higher doses; in contrast, DDS is primarily associated with shorter-acting, higher-potency dopaminergic medications, such as apomorphine and levodopa. Possible risk factors for ICDs include male sex, younger age and younger age at PD onset, a pre-PD history of ICDs, and a personal or family history of substance abuse, bipolar disorder, or gambling problems. Given the paucity of treatment options and potentially serious consequences, it is critical for PD patients to be monitored closely for development of ICDs as part of routine clinical care. © 2014 International Parkinson and Movement Disorder Society.

Improving the quality of physical health monitoring in CAMHS for children and adolescents prescribed medication for ADHD.

PubMed

Oxley, Cristal; Moghraby, Omer S; Samuel, Rani; Joyce, Dan W

2018-01-01

Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterised by a persistent, pervasive pattern of inattention, impulsivity and hyperactivity. Stimulant medication such as methylphenidate has an established evidence base in the treatment of children and adolescents with ADHD. However, it is also associated with a risk of side effects which may include decreased appetite, increased blood pressure and possible reduced growth. Monitoring physical health in children and adolescents prescribed medication for ADHD is a key clinical responsibility and includes a number of parameters as outlined in the National Institute for Health and Care Excellence Guidelines. Ascertaining the centiles of physical observations is essential to put these into developmental context and accurately inform treatment decisions. This quality improvement project aimed to improve physical health monitoring in children and adolescents prescribed stimulant medication for ADHD within a large specialist urban inner-city Child and Adolescent Mental Health Service (CAMHS) in South London and Maudsley NHS Foundation Trust. Baseline data were obtained to establish the quality of physical monitoring including blood pressure, height, weight and centiles. Targeted interventions included the development of a novel web-based application designed to calculate and record centiles. We report an improvement in total proportion compliance with physical health monitoring from 24% to 75%. The frequency of recording baseline blood pressure centiles increased from 0% to 62%; recording baseline height centiles increased from 37% to 81% and recording baseline weight centiles increased from 37% to 81%. Improvement in the delivery of high-quality care was achieved and sustained through close collaboration with clinicians involved in the treatment pathway in order to elicit and respond effectively to feedback for improvement and codevelop interventions which were highly effective within the clinical system. We believe this model to be replicable in other CAMHS services and ADHD clinics to improve the delivery of high-quality clinical care.

Baseline pressure errors (BPEs) extensively influence intracranial pressure scores: results of a prospective observational study

PubMed Central

2014-01-01

Background Monitoring of intracranial pressure (ICP) is a cornerstone in the surveillance of neurosurgical patients. The ICP is measured against a baseline pressure (i.e. zero - or reference pressure). We have previously reported that baseline pressure errors (BPEs), manifested as spontaneous shift or drifts in baseline pressure, cause erroneous readings of mean ICP in individual patients. The objective of this study was to monitor the frequency and severity of BPEs. To this end, we performed a prospective, observational study monitoring the ICP from two separate ICP sensors (Sensors 1 and 2) placed in close proximity in the brain. We characterized BPEs as differences in mean ICP despite near to identical ICP waveform in Sensors 1 and 2. Methods The study enrolled patients with aneurysmal subarachnoid hemorrhage in need of continuous ICP monitoring as part of their intensive care management. The two sensors were placed close to each other in the brain parenchyma via the same burr hole. The monitoring was performed as long as needed from a clinical perspective and the ICP recordings were stored digitally for analysis. For every patient the mean ICP as well as the various ICP wave parameters of the two sensors were compared. Results Sixteen patients were monitored median 164 hours (ranges 70 – 364 hours). Major BPEs, as defined by marked differences in mean ICP despite similar ICP waveform, were seen in 9 of them (56%). The BPEs were of magnitudes that had the potential to alter patient management. Conclusions Baseline Pressure Errors (BPEs) occur in a significant number of patients undergoing continuous ICP monitoring and they may alter patient management. The current practice of measuring ICP against a baseline pressure does not comply with the concept of State of the Art. Monitoring of the ICP waves ought to become the new State of the Art as they are not influenced by BPEs. PMID:24472296

Self-testing security sensor for monitoring closure of vault doors and the like

DOEpatents

Cawthorne, Duane C.

1997-05-27

A self-testing device is provided for a monitoring system for monitoring whether a closure member such as a door or window is closed. The monitoring system includes a switch unit mounted on the frame of the closure member being monitored and including magnetically biased switches connected in one or more electrical monitoring circuits, and a door magnet unit mounted on the closure member being monitored. The door magnet includes one or more permanent magnets that produce a magnetic field which, when the closure member is closed, cause said switches to assume a first state. When the closure member is opened, the switches switch to a second, alarm state. The self-testing device is electrically controllable from a remote location and produces a canceling or diverting magnetic field which simulates the effect of movement of the closure member from the closed position thereof without any actual movement of the member.

Self-testing security sensor for monitoring closure of vault doors and the like

DOEpatents

Cawthorne, D.C.

1997-05-27

A self-testing device is provided for a monitoring system for monitoring whether a closure member such as a door or window is closed. The monitoring system includes a switch unit mounted on the frame of the closure member being monitored and including magnetically biased switches connected in one or more electrical monitoring circuits, and a door magnet unit mounted on the closure member being monitored. The door magnet includes one or more permanent magnets that produce a magnetic field which, when the closure member is closed, cause said switches to assume a first state. When the closure member is opened, the switches switch to a second, alarm state. The self-testing device is electrically controllable from a remote location and produces a canceling or diverting magnetic field which simulates the effect of movement of the closure member from the closed position thereof without any actual movement of the member. 5 figs.

New technologies in the treatment of type 1 diabetes.

PubMed

Schmidt, Signe

2013-11-01

Type 1 diabetes is a chronic condition characterized by insufficient production of insulin, a hormone needed for proper control of blood glucose levels. People with type 1 diabetes must monitor their blood glucose throughout the day using a glucose meter or a continuous glucose monitor, calculate how much insulin is needed to maintain normal blood glucose levels, and administer the insulin dose by pen injection or insulin pump infusion into the subcutaneous tissue. In recent years, several new technologies for the treatment of type 1 diabetes have been developed. This PhD thesis covers two studies of the effects of commercially available technologies--sensor-augmented pump therapy and automated insulin bolus calculators--when used in clinical practice. Both studies demonstrated that these technologies have the potential to improve diabetes care. In addition, two in-clinic studies related to emerging technologies--closed-loop glucose control and virtual simulation environments--are included in the thesis. The results of these experiments provided proof of concept and will serve as a basis for further research in these fields.

Advanced Practice Internship: Experiential Learning in a Drug Use and Disease State Management Program

PubMed Central

Skledar, Susan J.; McKaveney, Teresa P.; Ward, Charles O.; Culley, Colleen M.; Ervin, Kelly C.; Weber, Robert J.

2006-01-01

Objective Establish a 3-year hospital internship within a drug use and disease state management program that would provide doctor of pharmacy students with experiential learning while still completing their classroom studies. Design As paid interns, students engaged in group and individual activities that assessed clinical practice guidelines. Patient monitoring and clinical intervention techniques were learned through prospective evaluation of drug therapy. Students designed evidence-based treatment guidelines and participated in all phases of development, including multidisciplinary approval, implementation, and evaluation stages. Assessment Student competency was continually monitored through direct observation by a preceptor and written examinations. Patient case studies, group discussions, and poster presentations allowed assessment of student growth in knowledge and communication skills. Conclusion The comprehensive structure of this internship provides a broad perspective for understanding the role of the hospital pharmacist in providing pharmaceutical care. Close supervision maximizes student learning potential and fosters a mentoring relationship for both personal and professional growth. PMID:17136188

A national clinical quality program for Veterans Affairs catheterization laboratories (from the Veterans Affairs clinical assessment, reporting, and tracking program).

PubMed

Maddox, Thomas M; Plomondon, Mary E; Petrich, Megan; Tsai, Thomas T; Gethoffer, Hans; Noonan, Gregory; Gillespie, Brian; Box, Tamara; Fihn, Stephen D; Jesse, Robert L; Rumsfeld, John S

2014-12-01

A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system. Published by Elsevier Inc.

7 CFR 3431.24 - Reporting requirements, monitoring, and close-out.

Code of Federal Regulations, 2011 CFR

2011-01-01

... INSTITUTE OF FOOD AND AGRICULTURE VETERINARY MEDICINE LOAN REPAYMENT PROGRAM Administration of the Veterinary Medicine Loan Repayment Program § 3431.24 Reporting requirements, monitoring, and close-out. VMLRP...

Congenital Portosystemic Shunts: Clinic Heterogeneity Requires an Individual Management of the Patient.

PubMed

Chocarro, Gloria; Amesty, María Virginia; Encinas, Jose Luis; Vilanova Sánchez, Alejandra; Hernandez, Francisco; Andres, Ane M; Gamez, Manolo; Tovar, Juan Antonio; Lopez Santamaria, Manuel

2016-02-01

Congenital portosystemic shunt (CPSS) is a rare entity without insufficiency in treatment issues. The aim of this article is to show our experience in the heterogeneity of this condition. A retrospective study of 25 CPSS in the period 1995 to 2014 was conducted. Description of the morphology, clinical impact, and treatment is given. According to the imaging techniques (IT), the shunt was apparently intrahepatic in 14 patients, extrahepatic in 10 patients, and mixed in 1 patient. In 14 children, IT showed hepatic portal circulation. In total shunts in which radiological examination was performed, invasive radiological techniques were able to demonstrate intrahepatic portal vein. In other patients, it was not investigated as they are asymptomatic. A child presented multiorgan failure with fulminant hepatic failure at birth. The shunt was radiologically closed and clinical impairment reversed rapidly. He is now asymptomatic with no longer images of CPSS in ultrasound scan controls. Also, seven children are asymptomatic at this time and are monitored periodically. Seven children had prenatal diagnosis, in five the shunt closed spontaneously. Nine children were symptomatic in their evolution (hyperammonemia, regenerative nodules, cholestasis, gastrointestinal bleeding). Of these, in five we performed balloon test occlusion, tolerated in all patients, followed by radiological closure. In our experience, the advancement of interventional radiology techniques avoided surgery to close the shunt. Morphologically, the CPSS is extremely heterogeneous, with multiple possible connections established. CPSS has multiple clinical presentations, from asymptomatic patients to acute liver failure. The therapeutic approach should be individualized and therefore held in overspecialized centers. Georg Thieme Verlag KG Stuttgart · New York.

Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial.

PubMed

Tauschmann, Martin; Allen, Janet M; Wilinska, Malgorzata E; Thabit, Hood; Stewart, Zoë; Cheng, Peiyao; Kollman, Craig; Acerini, Carlo L; Dunger, David B; Hovorka, Roman

2016-07-01

To evaluate feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions without remote monitoring or supervision. In an open-label, randomized, free-living, crossover study design, 12 adolescents receiving insulin pump therapy (mean [±SD] age 15.4 ± 2.6 years; HbA1c 8.3 ± 0.9%; duration of diabetes 8.2 ± 3.4 years) underwent two 7-day periods of sensor-augmented insulin pump therapy or hybrid closed-loop insulin delivery without supervision or remote monitoring. During the closed-loop insulin delivery, a model predictive algorithm automatically directed insulin delivery between meals and overnight; prandial boluses were administered by participants using a bolus calculator. The proportion of time when the sensor glucose level was in the target range (3.9-10 mmol/L) was increased during closed-loop insulin delivery compared with sensor-augmented pump therapy (72 vs. 53%, P < 0.001; primary end point), the mean glucose concentration was lowered (8.7 vs. 10.1 mmol/L, P = 0.028), and the time spent above the target level was reduced (P = 0.005) without changing the total daily insulin amount (P = 0.55). The time spent in the hypoglycemic range was low and comparable between interventions. Unsupervised day-and-night hybrid closed-loop insulin delivery at home is feasible and safe in young people with type 1 diabetes. Compared with sensor-augmented insulin pump therapy, closed-loop insulin delivery may improve glucose control without increasing the risk of hypoglycemia in adolescents with suboptimally controlled type 1 diabetes. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Neural network classification of clinical neurophysiological data for acute care monitoring

NASA Technical Reports Server (NTRS)

Sgro, Joseph

1994-01-01

The purpose of neurophysiological monitoring of the 'acute care' patient is to allow the accurate recognition of changing or deteriorating neurological function as close to the moment of occurrence as possible, thus permitting immediate intervention. Results confirm that: (1) neural networks are able to accurately identify electroencephalogram (EEG) patterns and evoked potential (EP) wave components, and measuring EP waveform latencies and amplitudes; (2) neural networks are able to accurately detect EP and EEG recordings that have been contaminated by noise; (3) the best performance was obtained consistently with the back propagation network for EP and the HONN for EEG's; (4) neural network performed consistently better than other methods evaluated; and (5) neural network EEG and EP analyses are readily performed on multichannel data.

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 assessment methodology to target on-site monitoring visits, statistically significant improvement was seen in a majority of measurable risk factors at the worst performing site quantiles. For the three risk factors which are most critical to the overall compliance of cardiac rhythm management medical device studies: follow-up compliance rate, unavailability of critical data, and noncompliance rate, we measured significant improvement in data quality. Although the worst performing site quantiles improved but not significantly in some risk factors such as subject attrition, the data-driven risk assessment highlighted key areas on which to continue focusing both on-site and centralized monitoring efforts. Data-driven surveillance of clinical trial performance provides actionable observations that can improve site performance. Clinical trials utilizing risk-based monitoring by leveraging a data-driven quality assessment combined with specific operational procedures may lead to an improvement in data quality and resource efficiencies.

Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink)

PubMed Central

Brachmann, Johannes; Böhm, Michael; Rybak, Karin; Klein, Gunnar; Butter, Christian; Klemm, Hanno; Schomburg, Rolf; Siebermair, Johannes; Israel, Carsten; Sinha, Anil-Martin; Drexler, Helmut

2011-01-01

Aims The Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink (OptiLink HF) study is designed to investigate whether OptiVol fluid status monitoring with an automatically generated wireless CareAlert notification via the CareLink Network can reduce all-cause death and cardiovascular hospitalizations in an HF population, compared with standard clinical assessment. Methods Patients with newly implanted or replacement cardioverter-defibrillator devices with or without cardiac resynchronization therapy, who have chronic HF in New York Heart Association class II or III and a left ventricular ejection fraction ≤35% will be eligible to participate. Following device implantation, patients are randomized to either OptiVol fluid status monitoring through CareAlert notification or regular care (OptiLink ‘on' vs. ‘off'). The primary endpoint is a composite of all-cause death or cardiovascular hospitalization. It is estimated that 1000 patients will be required to demonstrate superiority of the intervention group to reduce the primary outcome by 30% with 80% power. Conclusion The OptiLink HF study is designed to investigate whether early detection of congestion reduces mortality and cardiovascular hospitalization in patients with chronic HF. The study is expected to close recruitment in September 2012 and to report first results in May 2014. ClinicalTrials.gov Identifier: NCT00769457 PMID:21555324

Clinical Immunology Review Series: An approach to the patient with angio-oedema

PubMed Central

Grigoriadou, S; Longhurst, H J

2009-01-01

Angio-oedema is a common reason for attendance at the accident and emergency department and for referral to immunology/allergy clinics. Causative factors should always be sought, but a large proportion of patients have the idiopathic form of the disease. A minority of patients represent a diagnostic and treatment challenge. Failure to identify the more unusual causes of angio-oedema may result in life-threatening situations. Common and rare causes of angio-oedema will be discussed in this article, as well as the diagnostic and treatment pathways for the management of these patients. A comprehensive history and close monitoring of response to treatment are the most cost-effective diagnostic and treatment tools. PMID:19220828

LabVIEW: a software system for data acquisition, data analysis, and instrument control.

PubMed

Kalkman, C J

1995-01-01

Computer-based data acquisition systems play an important role in clinical monitoring and in the development of new monitoring tools. LabVIEW (National Instruments, Austin, TX) is a data acquisition and programming environment that allows flexible acquisition and processing of analog and digital data. The main feature that distinguishes LabVIEW from other data acquisition programs is its highly modular graphical programming language, "G," and a large library of mathematical and statistical functions. The advantage of graphical programming is that the code is flexible, reusable, and self-documenting. Subroutines can be saved in a library and reused without modification in other programs. This dramatically reduces development time and enables researchers to develop or modify their own programs. LabVIEW uses a large amount of processing power and computer memory, thus requiring a powerful computer. A large-screen monitor is desirable when developing larger applications. LabVIEW is excellently suited for testing new monitoring paradigms, analysis algorithms, or user interfaces. The typical LabVIEW user is the researcher who wants to develop a new monitoring technique, a set of new (derived) variables by integrating signals from several existing patient monitors, closed-loop control of a physiological variable, or a physiological simulator.

Monitoring mental health treatment acceptance and initial treatment adherence in veterans: veterans of Operations Enduring Freedom and Iraqi Freedom versus other veterans of other eras.

PubMed

Lindley, Steven; Cacciapaglia, Holly; Noronha, Delilah; Carlson, Eve; Schatzberg, Alan

2010-10-01

Identifying factors that influence mental health outcomes in veterans can aid in the redesign of programs to maximize the likelihood of early resolution of problems. To that end, we examined demographic and clinical process data from 2,684 veterans who scored positive on a mental health screen. We investigated this data set for patterns and possible predictors of mental health referral acceptance and attendance. The majority of patients had not received mental health treatment within the last two years (76%). Veterans of Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) were more likely to accept a mental health referral for depression but were equally likely to attend a mental health visit as other era veterans. Decreased acceptance was associated with provider type and contact method, clinic location, depression only, and specific age ranges (65-74). Among those who accepted a referral, decreased attendance was associated with clinic location, depression only, and retirement. No variables predicted OEF/OIF acceptance/attendance. In conclusion, our findings illustrate the importance of close, continual monitoring of clinical process data to help reveal targets for improving mental health care for veterans. © 2010 Association for Research in Nervous and Mental Disease.

[The determination of arterial pressure by the physician or the nurse: its relation to ambulatory pressure and left ventricular mass. The MAPA-Madrid Group. Monitorización Ambulatoria de la Presión Arterial (Ambulatory Monitoring of Arterial Pressure)].

PubMed

Martínez, M A; Aguirre, A; Sánchez, M; Nevado, A; Laguna, I; Torre, A; Manuel, E; Villar, C; García-Puig, J

1999-12-11

In the present study we evaluated the influence of the observer's status--physician or nurse--on blood pressure levels and the relationship among clinic blood pressure measurement with ambulatory blood pressure and left ventricle mass. Cross sectional study performed in seven primary care centers. Participating physicians and nurses were trained for blood pressure measurement prior to the study and subsequently retrained at 3 month intervals during the study. Patients included in the study were 122 subjects with mild to moderate hypertension who underwent the following study protocol: a) measurement of clinic blood pressure by physician and nurse, in an independent fashion, on 3 visits; b) clinic-epidemiologic questionnaire; c) conventional hematological and biochemical study; d) electrocardiogram; e) 24-hour ambulatory blood pressure monitoring, f) M-mode and Doppler echocardiography (only in 58 subjects). Nurse-measured blood pressure levels were higher than those determined by physicians (mean differences: 3.9 [6.7] mmHg in systolic blood pressure and 2.6 [5.4] mmHg in diastolic blood pressure). The blood pressure level differences between the two observers were higher in female patients and subjects with low educational level, independently of the observer's gender. Nurse-measured blood pressure was more closely related to ambulatory blood pressure and left ventricle mass than physician-measured blood pressure. Nurse-measured blood pressure levels are lower than those determined by physicians and more closely related to ambulatory blood pressure and left ventricle mass than physician-measured blood pressure. These data support that nurses, instead of doctors, should routinely measure blood pressure in primary care centers.

Seven-Year Clinical Surveillance Program Demonstrates Consistent MARD Accuracy Performance of a Blood Glucose Test Strip.

PubMed

Setford, Steven; Grady, Mike; Mackintosh, Stephen; Donald, Robert; Levy, Brian

2018-05-01

MARD (mean absolute relative difference) is increasingly used to describe performance of glucose monitoring systems, providing a single-value quantitative measure of accuracy and allowing comparisons between different monitoring systems. This study reports MARDs for the OneTouch Verio® glucose meter clinical data set of 80 258 data points (671 individual batches) gathered as part of a 7.5-year self-surveillance program Methods: Test strips were routinely sampled from randomly selected manufacturer's production batches and sent to one of 3 clinic sites for clinical accuracy assessment using fresh capillary blood from patients with diabetes, using both the meter system and standard laboratory reference instrument. Evaluation of the distribution of strip batch MARD yielded a mean value of 5.05% (range: 3.68-6.43% at ±1.96 standard deviations from mean). The overall MARD for all clinic data points (N = 80 258) was also 5.05%, while a mean bias of 1.28 was recorded. MARD by glucose level was found to be consistent, yielding a maximum value of 4.81% at higher glucose (≥100 mg/dL) and a mean absolute difference (MAD) of 5.60 mg/dL at low glucose (<100 mg/dL). MARD by year of manufacture varied from 4.67-5.42% indicating consistent accuracy performance over the surveillance period. This 7.5-year surveillance program showed that this meter system exhibits consistently low MARD by batch, glucose level and year, indicating close agreement with established reference methods whilste exhibiting lower MARD values than continuous glucose monitoring (CGM) systems and providing users with confidence in the performance when transitioning to each new strip batch.

Open-access MIMIC-II database for intensive care research.

PubMed

Lee, Joon; Scott, Daniel J; Villarroel, Mauricio; Clifford, Gari D; Saeed, Mohammed; Mark, Roger G

2011-01-01

The critical state of intensive care unit (ICU) patients demands close monitoring, and as a result a large volume of multi-parameter data is collected continuously. This represents a unique opportunity for researchers interested in clinical data mining. We sought to foster a more transparent and efficient intensive care research community by building a publicly available ICU database, namely Multiparameter Intelligent Monitoring in Intensive Care II (MIMIC-II). The data harnessed in MIMIC-II were collected from the ICUs of Beth Israel Deaconess Medical Center from 2001 to 2008 and represent 26,870 adult hospital admissions (version 2.6). MIMIC-II consists of two major components: clinical data and physiological waveforms. The clinical data, which include patient demographics, intravenous medication drip rates, and laboratory test results, were organized into a relational database. The physiological waveforms, including 125 Hz signals recorded at bedside and corresponding vital signs, were stored in an open-source format. MIMIC-II data were also deidentified in order to remove protected health information. Any interested researcher can gain access to MIMIC-II free of charge after signing a data use agreement and completing human subjects training. MIMIC-II can support a wide variety of research studies, ranging from the development of clinical decision support algorithms to retrospective clinical studies. We anticipate that MIMIC-II will be an invaluable resource for intensive care research by stimulating fair comparisons among different studies.

An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada.

PubMed

Komparic, Ana; Smith, Maxwell J; Thompson, Alison

2016-04-01

Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.

Motor recovery monitoring using acceleration measurements in post acute stroke patients.

PubMed

Gubbi, Jayavardhana; Rao, Aravinda S; Fang, Kun; Yan, Bernard; Palaniswami, Marimuthu

2013-04-16

Stroke is one of the major causes of morbidity and mortality. Its recovery and treatment depends on close clinical monitoring by a clinician especially during the first few hours after the onset of stroke. Patients who do not exhibit early motor recovery post thrombolysis may benefit from more aggressive treatment. A novel approach for monitoring stroke during the first few hours after the onset of stroke using a wireless accelerometer based motor activity monitoring system is developed. It monitors the motor activity by measuring the acceleration of the arms in three axes. In the presented proof of concept study, the measured acceleration data is transferred wirelessly using iMote2 platform to the base station that is equipped with an online algorithm capable of calculating an index equivalent to the National Institute of Health Stroke Score (NIHSS) motor index. The system is developed by collecting data from 15 patients. We have successfully demonstrated an end-to-end stroke monitoring system reporting an accuracy of calculating stroke index of more than 80%, highest Cohen's overall agreement of 0.91 (with excellent κ coefficient of 0.76). A wireless accelerometer based 'hot stroke' monitoring system is developed to monitor the motor recovery in acute-stroke patients. It has been shown to monitor stroke patients continuously, which has not been possible so far with high reliability.

Motor recovery monitoring using acceleration measurements in post acute stroke patients

PubMed Central

2013-01-01

Background Stroke is one of the major causes of morbidity and mortality. Its recovery and treatment depends on close clinical monitoring by a clinician especially during the first few hours after the onset of stroke. Patients who do not exhibit early motor recovery post thrombolysis may benefit from more aggressive treatment. Method A novel approach for monitoring stroke during the first few hours after the onset of stroke using a wireless accelerometer based motor activity monitoring system is developed. It monitors the motor activity by measuring the acceleration of the arms in three axes. In the presented proof of concept study, the measured acceleration data is transferred wirelessly using iMote2 platform to the base station that is equipped with an online algorithm capable of calculating an index equivalent to the National Institute of Health Stroke Score (NIHSS) motor index. The system is developed by collecting data from 15 patients. Results We have successfully demonstrated an end-to-end stroke monitoring system reporting an accuracy of calculating stroke index of more than 80%, highest Cohen’s overall agreement of 0.91 (with excellent κ coefficient of 0.76). Conclusion A wireless accelerometer based ‘hot stroke’ monitoring system is developed to monitor the motor recovery in acute-stroke patients. It has been shown to monitor stroke patients continuously, which has not been possible so far with high reliability. PMID:23590690

A novel surgical management of hypopharyngeal branchial anomalies.

PubMed

Givens, Daniel J; Buchmann, Luke O; Park, Albert H

2015-04-01

To review our experience treating hypopharyngeal branchial anomalies utilizing an open transcervical approach that: (1) includes recurrent laryngeal nerve (RLN) monitoring and identification if needed; (2) resection of tract if present; and (3) a superiorly based sternothyroid muscle flap for closure. A retrospective chart review was performed to identify all patients at a tertiary level children's hospital with branchial anomalies from 2005 to 2014. The clinical presentation, evaluation, treatment and outcome were analyzed for those patients with hypopharyngeal branchial anomalies. Forty-seven patients who underwent excision of branchial anomalies with a known origin were identified. Thirteen patients had hypopharyngeal branchial anomalies. Six of these patients were treated by the authors of this study and are the focus of this analysis. All six underwent an open transcervical procedure with a sternothyroid muscle flap closure of a piriform sinus opening over a nine year period. Definitive surgery included a microlaryngoscopy and an open transcervical approach to close a fistula between the piriform sinus and neck with recurrent laryngeal nerve monitoring or dissection. A superiorly based sternothyroid muscle flap was used to close the sinus opening. There were no recurrences, recurrent laryngeal nerve injuries or other complications from these procedures. This study supports complete surgical extirpation of the fistula tract using an open cervical approach, recurrent laryngeal nerve monitoring or identification, and rotational muscle flap closure to treat patients with hypopharyngeal branchial anomalies. Published by Elsevier Ireland Ltd.

Testing & Evaluation of Close-Range SAR for Monitoring & Automatically Detecting Pavement Conditions

DOT National Transportation Integrated Search

2012-01-01

This report summarizes activities in support of the DOT contract on Testing & Evaluating Close-Range SAR for Monitoring & Automatically Detecting Pavement Conditions & Improve Visual Inspection Procedures. The work of this project was performed by Dr...

40 CFR 98.434 - Monitoring and QA/QC requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Contained in Pre-Charged Equipment or Closed-Cell Foams § 98.434 Monitoring and QA/QC requirements. (a) For... equipment or closed-cell foam in the correct quantities (metric tons) and units (kg per piece of equipment...

40 CFR 98.434 - Monitoring and QA/QC requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Contained in Pre-Charged Equipment or Closed-Cell Foams § 98.434 Monitoring and QA/QC requirements. (a) For... equipment or closed-cell foam in the correct quantities (metric tons) and units (kg per piece of equipment...

40 CFR 98.434 - Monitoring and QA/QC requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Contained in Pre-Charged Equipment or Closed-Cell Foams § 98.434 Monitoring and QA/QC requirements. (a) For... equipment or closed-cell foam in the correct quantities and units. [74 FR 56374, Oct. 30, 2009, as amended...

Atmospheric Monitoring Strategy for Ground Testing of Closed Ecological Life Support Systems

NASA Technical Reports Server (NTRS)

Feighery, John; Cavenall, Ivan; Knight, Amanda

2004-01-01

This paper reviews the evolution and current state of atmospheric monitoring on the International Space Station to provide context from which we can imagine a more advanced and integrated system. The unique environmental hazards of human space flight are identified and categorized into groups, taking into consideration the time required for the hazard to become a threat to human health or performance. The key functions of a comprehensive monitoring strategy for a closed ecological life support system are derived from past experience and a survey of currently available technologies for monitoring air quality. Finally, a system architecture is developed incorporating the lessons learned from ISS and other analogous closed life support systems. The paper concludes by presenting recommendations on how to proceed with requirements definition and conceptual design of an air monitoring system for exploration missions.

A Case Report of Gastrointestinal Hemorrhage and Perforation During Apatinib Treatment of Gastric Cancer.

PubMed

Li, Xiao-Fen; Tan, Yi-Nuo; Cao, Ying; Xu, Jing-Hong; Zheng, Shu; Yuan, Ying

2015-09-01

Apatinib is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2, which shows good efficacy and safety in clinical trials for chemotherapy-refractory gastric cancer patients. Till now, there is no case report after apatinib came in the market. We presented a 55-year-old Chinese woman with advanced gastric cancer, who received apatinib after failure of second-line chemotherapy. On the 19th day of apatinib administration, she suffered from gastrointestinal hemorrhage. Then, her condition rapidly deteriorated to gastrointestinal perforation. Although the patient received timely medical and surgical treatment, she finally died of septic shock. Although apatinib shows exciting efficacy and good tolerance in phase II and III clinical trials, this novel targeted drug should be prescribed carefully and close clinical monitoring is needed when using it.

A Case Report of Gastrointestinal Hemorrhage and Perforation During Apatinib Treatment of Gastric Cancer

PubMed Central

Li, Xiao-Fen; Tan, Yi-Nuo; Cao, Ying; Xu, Jing-Hong; Zheng, Shu; Yuan, Ying

2015-01-01

Abstract Apatinib is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2, which shows good efficacy and safety in clinical trials for chemotherapy-refractory gastric cancer patients. Till now, there is no case report after apatinib came in the market. We presented a 55-year-old Chinese woman with advanced gastric cancer, who received apatinib after failure of second-line chemotherapy. On the 19th day of apatinib administration, she suffered from gastrointestinal hemorrhage. Then, her condition rapidly deteriorated to gastrointestinal perforation. Although the patient received timely medical and surgical treatment, she finally died of septic shock. Although apatinib shows exciting efficacy and good tolerance in phase II and III clinical trials, this novel targeted drug should be prescribed carefully and close clinical monitoring is needed when using it. PMID:26426663

Molecular evidence for a terrestrial origin of snakes

NASA Technical Reports Server (NTRS)

Vidal, Nicolas; Hedges, S. Blair

2004-01-01

Biologists have debated the origin of snakes since the nineteenth century. One hypothesis suggests that snakes are most closely related to terrestrial lizards, and reduced their limbs on land. An alternative hypothesis proposes that snakes are most closely related to Cretaceous marine lizards, such as mosasaurs, and reduced their limbs in water. A presumed close relationship between living monitor lizards, believed to be close relatives of the extinct mosasaurs, and snakes has bolstered the marine origin hypothesis. Here, we show that DNA sequence evidence does not support a close relationship between snakes and monitor lizards, and thus supports a terrestrial origin of snakes.

Our Fat Future: Translating Adipose Stem Cell Therapy.

PubMed

Nordberg, Rachel C; Loboa, Elizabeth G

2015-09-01

Human adipose stem cells (hASCs) have the potential to treat patients with a variety of clinical conditions. Recent advancements in translational research, regulatory policy, and industry have positioned hASCs on the threshold of clinical translation. We discuss the progress and challenges of bringing adipose stem cell therapy into mainstream clinical use. This article details the advances made in recent years that have helped move human adipose stem cell therapy toward mainstream clinical use from a translational research, regulatory policy, and industrial standpoint. Four recurrent themes in translational technology as they pertain to human adipose stem cells are discussed: automated closed-system operations, biosensors and real-time monitoring, biomimetics, and rapid manufacturing. In light of recent FDA guidance documents, regulatory concerns about adipose stem cell therapy are discussed. Finally, an update is provided on the current state of clinical trials and the emerging industry that uses human adipose stem cells. This article is expected to stimulate future studies in translational adipose stem cell research. ©AlphaMed Press.

Quantification of abnormal intracranial pressure waves and isotope cisternography for diagnosis of occult communicating hydrocephalus

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

Cardoso, E.R.; Piatek, D.; Del Bigio, M.R.

1989-01-01

Nineteen consecutive patients with suspected occult communicating hydrocephalus were investigated by means of clinical evaluation, neuropsychological testing, isotope cisternography, computed tomography scanning, and continuous intracranial pressure monitoring. Semi-quantitative grading systems were used in the evaluation of the clinical, neuropsychological, and cisternographic assessments. Clinical examination, neuropsychological testing, and computed tomography scanning were repeated 3 months after ventriculoperitoneal shunting. All patients showed abnormal intracranial pressure waves and all improved after shunting. There was close correlation between number, peak, and pulse pressures of B waves and the mean intracranial pressure. However, quantification of B waves by means of number, frequency, and amplitude didmore » not help in predicting the degree of clinical improvement postshunting. The most sensitive predictor of favorable response to shunting was enlargement of the temporal horns on computed tomography scan. Furthermore, the size of temporal horns correlated with mean intracranial pressure. There was no correlation between abnormalities on isotope cisternography and clinical improvement.« less

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 median age was 35 years; 136 (17%) were aged <18 years. Thirteen of 256 women of reproductive age (5%) were pregnant. The country of passport issuance was known for 720 of the travelers. The majority of monitored travelers (478 [66%]) used a non-U.S. passport including 442 (61%) Liberian nationals. A total of 772 (99%) travelers were “low (but not zero)” risk; 11 (1%) were “some” risk. Among monitored travelers, 43 (5%) experienced illness symptoms; 29 (67%) had a symptom consistent with EVD. Two were tested for Ebola virus disease and had negative results. Most frequently reported symptoms were fever (20/43, 47%) and abdominal pain (12/43, 28%). During evaluation, 16 (37%) of 43 travelers reported their symptoms began prior to travel; chronic health conditions in 24 travelers including tumors/cancer, pregnancy, and orthopedic conditions were most common. Infectious causes in 19 travelers included upper respiratory infection, malaria, and gastrointestinal infections. Discussion Prior to 2014, no similar active monitoring program for travelers had been performed in Minnesota; assessment and management of symptomatic travelers was a new activity for MDH. Ensuring safe entrance into healthcare was particularly challenging for children, and pregnant women, as well as those without an established connection to healthcare. Unnecessary inpatient evaluations were successfully avoided by close clinical follow-up by phone. Before similar monitoring programs are considered in the future, careful thought must be given to necessary resources and the impact on affected populations, public health, and the healthcare system. PMID:27907013

Feasibility of blind aortic catheter placement in the prehospital environment to guide resuscitation in cardiac arrest.

PubMed

Manning, James E

2013-08-01

Aortic catheter-based resuscitation therapies are emerging with laboratory investigations showing benefit in models of trauma-related noncompressible torso hemorrhage and nontraumatic cardiac arrest. For these investigational aortic catheter-based therapies to reach their greatest potential clinical benefit, the ability to initiate them in the prehospital setting will be important. Feasibility of prehospital aortic catheterization without imaging capability supports this potential and is described in this report. A physician prehospital response system was created in cooperation with the local emergency medical services system to provide invasive hemodynamic monitoring during cardiac arrest. Physicians were dispatched to all known or suspected prehospital cardiac arrests covered by the emergency medical services system. Physicians responded with a specialized vascular catheterization pack and a monitor with invasive pressure monitoring capability. The physicians performed blind thoracic aortic and central venous catheterizations in cardiac arrest patients in the prehospital setting to measure coronary perfusion pressure, to optimize closed-chest cardiopulmonary resuscitation technique, and to administer intra-aortic epinephrine. During a 2-year period, 22 medical cardiac arrest patients underwent prehospital invasive hemodynamic monitoring to guide resuscitation. Most patients had both aortic and central venous catheters inserted. The combination of intra-aortic epinephrine and adjustments in closed-chest cardiopulmonary resuscitation technique resulted in improved coronary perfusion pressure. Return of spontaneous circulation with survival to hospital admission was achieved in 50% (11 of 22) of these patients. This report demonstrates the feasibility of successful blind aortic and central venous catheterizations in the prehospital environment and supports the potential feasibility of other emerging aortic catheter-based resuscitation therapies.

The use of personalized biomarkers and liquid biopsies to monitor treatment response and disease recurrence in locally advanced rectal cancer after neoadjuvant chemoradiation.

PubMed

Carpinetti, Paola; Donnard, Elisa; Bettoni, Fabiana; Asprino, Paula; Koyama, Fernanda; Rozanski, Andrei; Sabbaga, Jorge; Habr-Gama, Angelita; Parmigiani, Raphael B; Galante, Pedro A F; Perez, Rodrigo O; Camargo, Anamaria A

2015-11-10

Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is the mainstay treatment for locally advanced rectal cancer. Variable degrees of tumor regression are observed after nCRT and alternative treatment strategies, including close surveillance without immediate surgery, have been investigated to spare patients with complete tumor regression from potentially adverse outcomes of radical surgery. However, clinical and radiological assessment of response does not allow accurate identification of patients with complete response. In addition, surveillance for recurrence is similarly important for these patients, as early detection of recurrence allows salvage resections and adjuvant interventions. We report the use of liquid biopsies and personalized biomarkers for monitoring treatment response to nCRT and detecting residual disease and recurrence in patients with rectal cancer. We sequenced the whole-genome of four rectal tumors to identify patient-specific chromosomal rearrangements that were used to monitor circulating tumor DNA (ctDNA) in liquid biopsies collected at diagnosis and during nCRT and follow-up. We compared ctDNA levels to clinical, radiological and pathological response to nCRT. Our results indicate that personalized biomarkers and liquid biopsies may not be sensitive for the detection of microscopic residual disease. However, it can be efficiently used to monitor treatment response to nCRT and detect disease recurrence, preceding increases in CEA levels and radiological diagnosis. Similar good results were observed when assessing tumor response to systemic therapy and disease progression. Our study supports the use of personalized biomarkers and liquid biopsies to tailor the management of rectal cancer patients, however, replication in a larger cohort is necessary to introduce this strategy into clinical practice.

A dramatic increase in the positive blood culture rates of Helicobacter cinaedi: the evidence of differential detection abilities between the Bactec and BacT/Alert systems.

PubMed

Miyake, Noriko; Chong, Yong; Nishida, Ruriko; Nagasaki, Yoji; Kibe, Yasushi; Kiyosuke, Makiko; Shimomura, Takeshi; Shimono, Nobuyuki; Shimoda, Shinji; Akashi, Koichi

2015-11-01

In our hospital, positive blood culture rates of Helicobacter cinaedi dramatically increased after introducing the Bactec system. A simulated culture model of H. cinaedi bacteremia demonstrated no positive signals using the BacT/Alert system, despite efficient growth in bottles. Clinically suspected H. cinaedi bacteremia should be monitored more closely when using the BacT/Alert system, preferably with subcultivation after 7days of incubation. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical pharmacy cardiac risk service for managing patients with coronary artery disease in a health maintenance organization.

PubMed

Sandhoff, Brian G; Nies, Leslie K; Olson, Kari L; Nash, James D; Rasmussen, Jon R; Merenich, John A

2007-01-01

A clinical pharmacy service for managing the treatment of coronary artery disease in a health maintenance organization is described. Despite the proven benefits of aggressive risk factor modification for patients with coronary artery disease (CAD), there remains a treatment gap between consensus- and evidence-based recommendations and their application in patient care. In 1998, Kaiser Permanente of Colorado developed the Clinical Pharmacy Cardiac Risk Service (CPCRS) to focus on the long-term management of patients with CAD to improve clinical outcomes. The primary goals of the CPCRS are to increase the number of CAD patients on lipid-lowering therapy, manage medications shown to decrease the risk of future CAD-related events, assist in the monitoring and control of other diseases that increase cardiovascular risk, provide patient education and recommendations for nonpharmacologic therapy, and act as a CAD information resource for physicians and other health care providers. Using an electronic medical record and tracking database, the service works in close collaboration with primary care physicians, cardiologists, cardiac rehabilitation nurses, and other health care providers to reduce cardiac risk in the CAD population. Particular attention is given to dyslipidemia, blood pressure, diabetes mellitus, and tobacco cessation. Treatment with evidence-based regimens is initiated and adjusted as necessary. Over 11,000 patients are currently being followed by the CPCRS. A clinical pharmacy service in a large health maintenance organization provides cardiac risk reduction for patients with CAD and helps close treatment gaps that may exist for these patients.

Development and evaluation of an interactive electronic laboratory manual for cooperative learning of medical histology.

PubMed

Khalil, Mohammed K; Kirkley, Debbie L; Kibble, Jonathan D

2013-01-01

This article describes the development of an interactive computer-based laboratory manual, created to facilitate the teaching and learning of medical histology. The overarching goal of developing the manual is to facilitate self-directed group interactivities that actively engage students during laboratory sessions. The design of the manual includes guided instruction for students to navigate virtual slides, exercises for students to monitor learning, and cases to provide clinical relevance. At the end of the laboratory activities, student groups can generate a laboratory report that may be used to provide formative feedback. The instructional value of the manual was evaluated by a questionnaire containing both closed-ended and open-ended items. Closed-ended items using a five-point Likert-scale assessed the format and navigation, instructional contents, group process, and learning process. Open-ended items assessed student's perception on the effectiveness of the manual in facilitating their learning. After implementation for two consecutive years, student evaluation of the manual was highly positive and indicated that it facilitated their learning by reinforcing and clarifying classroom sessions, improved their understanding, facilitated active and cooperative learning, and supported self-monitoring of their learning. Copyright © 2013 American Association of Anatomists.

Comprehensive analysis of cochlear implant failure: usefulness of clinical symptom-based algorithm combined with in situ integrity testing.

PubMed

Yamazaki, Hiroshi; O'Leary, Stephen; Moran, Michelle; Briggs, Robert

2014-04-01

Accurate diagnosis of cochlear implant failures is important for management; however, appropriate strategies to assess possible device failures are not always clear. The purpose of this study is to understand correlation between causes of device failure and the presenting clinical symptoms as well as results of in situ integrity testing and to propose effective strategies for diagnosis of device failure. Retrospective case review. Cochlear implant center at a tertiary referral hospital. Twenty-seven cases with suspected device failure of Cochlear Nucleus systems (excluding CI512 failures) on the basis of deterioration in auditory perception from January 2000 to September 2012 in the Melbourne cochlear implant clinic. Clinical presentations and types of abnormalities on in situ integrity testing were compared with modes of device failure detected by returned device analysis. Sudden deterioration in auditory perception was always observed in cases with "critical damage": either fracture of the integrated circuit or most or all of the electrode wires. Subacute or gradually progressive deterioration in auditory perception was significantly associated with a more limited number of broken electrode wires. Cochlear implant mediated auditory and nonauditory symptoms were significantly associated with an insulation problem. An algorithm based on the time course of deterioration in auditory perception and cochlear implant-mediated auditory and nonauditory symptoms was developed on the basis of these retrospective analyses, to help predict the mode of device failure. In situ integrity testing, which included close monitoring of device function in routine programming sessions as well as repeating the manufacturer's integrity test battery, was sensitive enough to detect malfunction in all suspected device failures, and each mode of device failure showed a characteristic abnormality on in situ integrity testing. Our clinical manifestation-based algorithm combined with in situ integrity testing may be useful for accurate diagnosis and appropriate management of device failure. Close monitoring of device function in routine programming sessions as well as repeating the manufacturer's integrity test battery is important if the initial in situ integrity testing is inconclusive because objective evidence of failure in the implanted device is essential to recommend explantation/reimplantation.

Development of glucose-responsive 'smart' insulin systems.

PubMed

Rege, Nischay K; Phillips, Nelson F B; Weiss, Michael A

2017-08-01

The complexity of modern insulin-based therapy for type I and type II diabetes mellitus and the risks associated with excursions in blood-glucose concentration (hyperglycemia and hypoglycemia) have motivated the development of 'smart insulin' technologies (glucose-responsive insulin, GRI). Such analogs or delivery systems are entities that provide insulin activity proportional to the glycemic state of the patient without external monitoring by the patient or healthcare provider. The present review describes the relevant historical background to modern GRI technologies and highlights three distinct approaches: coupling of continuous glucose monitoring (CGM) to deliver devices (algorithm-based 'closed-loop' systems), glucose-responsive polymer encapsulation of insulin, and molecular modification of insulin itself. Recent advances in GRI research utilizing each of the three approaches are illustrated; these include newly developed algorithms for CGM-based insulin delivery systems, glucose-sensitive modifications of existing clinical analogs, newly developed hypoxia-sensitive polymer matrices, and polymer-encapsulated, stem-cell-derived pancreatic β cells. Although GRI technologies have yet to be perfected, the recent advances across several scientific disciplines that are described in this review have provided a path towards their clinical implementation.

A novel personal health system with integrated decision support and guidance for the management of chronic liver disease.

PubMed

Kiefer, Stephan; Schäfer, Michael; Bransch, Marco; Brimmers, Peter; Bartolomé, Diego; Baños, Janie; Orr, James; Jones, Dave; Jara, Maximilian; Stockmann, Martin

2014-01-01

A personal health system platform for the management of patients with chronic liver disease that incorporates a novel approach to integrate decision support and guidance through care pathways for patients and their doctors is presented in this paper. The personal health system incorporates an integrated decision support engine that guides patients and doctors through the management of the disease by issuing tasks and providing recommendations to both the care team and the patient and by controlling the execution of a Care Flow Plan based on the results of tasks and the monitored health status of the patient. This Care Flow Plan represents a formal, business process based model of disease management designed off-line by domain experts on the basis of clinical guidelines, knowledge of care pathways and an organisational model for integrated, patient-centred care. In this way, remote monitoring and treatment are dynamically adapted to the patient's actual condition and clinical symptoms and allow flexible delivery of care with close integration of specialists, therapists and care-givers.

7 CFR 3431.24 - Reporting requirements, monitoring, and close-out.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 15 2013-01-01 2013-01-01 false Reporting requirements, monitoring, and close-out. 3431.24 Section 3431.24 Agriculture Regulations of the Department of Agriculture (Continued) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE VETERINARY MEDICINE LOAN REPAYMENT PROGRAM Administration of the...

7 CFR 3431.24 - Reporting requirements, monitoring, and close-out.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 15 2014-01-01 2014-01-01 false Reporting requirements, monitoring, and close-out. 3431.24 Section 3431.24 Agriculture Regulations of the Department of Agriculture (Continued) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE VETERINARY MEDICINE LOAN REPAYMENT PROGRAM Administration of the...

7 CFR 3431.24 - Reporting requirements, monitoring, and close-out.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 15 2012-01-01 2012-01-01 false Reporting requirements, monitoring, and close-out. 3431.24 Section 3431.24 Agriculture Regulations of the Department of Agriculture (Continued) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE VETERINARY MEDICINE LOAN REPAYMENT PROGRAM Administration of the...

An unusual complication of invasive video-EEG monitoring: subelectrode hematoma without subdural component: case report.

PubMed

Bozkurt, Gokhan; Ayhan, Selim; Dericioglu, Nese; Saygi, Serap; Akalan, Nejat

2010-08-01

The potential complications of the subdural electrode implantation providing identification of the seizure focus and direct stimulation of the cerebral cortex for defining the eloquent cortical areas are epidural and subdural hematoma, cortical contusions, infection, brain edema, raised intracranial pressure, CSF leakage, and venous infarction have been previously reported in the literature. To present the first case of subelectrode hematoma without subdural component that was detected during invasive EEG monitoring after subdural electrode implantation. A 19-year-old female with drug resistant seizures was decided to undergo invasive monitoring with subdural electrodes. While good quality recordings had been initially obtained from all electrodes placed on the right parietal convexity, no cerebral cortical activity could be obtained from one electrode 2 days after the first operation. Explorative surgery revealed a circumscribed subelectrode hematoma without a subdural component. Awareness of the potential complications of subdural electrode implantation and close follow-up of the clinical findings of the patient are of highest value for early detection and successful management.

Ambulatory versus home versus clinic blood pressure: the association with subclinical cerebrovascular diseases: the Ohasama Study.

PubMed

Hara, Azusa; Tanaka, Kazushi; Ohkubo, Takayoshi; Kondo, Takeo; Kikuya, Masahiro; Metoki, Hirohito; Hashimoto, Takanao; Satoh, Michihiro; Inoue, Ryusuke; Asayama, Kei; Obara, Taku; Hirose, Takuo; Izumi, Shin-Ichi; Satoh, Hiroshi; Imai, Yutaka

2012-01-01

The usefulness of ambulatory, home, and casual/clinic blood pressure measurements to predict subclinical cerebrovascular diseases (silent cerebrovascular lesions and carotid atherosclerosis) was compared in a general population. Data on ambulatory, home, and casual/clinic blood pressures and brain MRI to detect silent cerebrovascular lesions were obtained in 1007 subjects aged ≥55 years in a general population of Ohasama, Japan. Of the 1007 subjects, 583 underwent evaluation of the extent of carotid atherosclerosis. Twenty-four-hour, daytime, and nighttime ambulatory and home blood pressure levels were closely associated with the risk of silent cerebrovascular lesions and carotid atherosclerosis (all P<0.05). When home and one of the ambulatory blood pressure values were simultaneously included in the same regression model, each of the ambulatory blood pressure values remained a significant predictor of silent cerebrovascular lesions, whereas home blood pressure lost its predictive value. Of the ambulatory blood pressure values, nighttime blood pressure was the strongest predictor of silent cerebrovascular lesions. The home blood pressure value was more closely associated with the risk of carotid atherosclerosis than any of the ambulatory blood pressure values when home and one of the ambulatory blood pressure values were simultaneously included in the same regression model. The casual/clinic blood pressure value had no significant association with the risk of subclinical cerebrovascular diseases. Although the clinical indications for ambulatory blood pressure monitoring and home blood pressure measurements may overlap, the clinical significance of each method for predicting target organ damage may differ for different target organs.

In silico preclinical trials: a proof of concept in closed-loop control of type 1 diabetes.

PubMed

Kovatchev, Boris P; Breton, Marc; Man, Chiara Dalla; Cobelli, Claudio

2009-01-01

Arguably, a minimally invasive system using subcutaneous (s.c.) continuous glucose monitoring (CGM) and s.c. insulin delivery via insulin pump would be a most feasible step to closed-loop control in type 1 diabetes mellitus (T1DM). Consequently, diabetes technology is focusing on developing an artificial pancreas using control algorithms to link CGM with s.c. insulin delivery. The future development of the artificial pancreas will be greatly accelerated by employing mathematical modeling and computer simulation. Realistic computer simulation is capable of providing invaluable information about the safety and the limitations of closed-loop control algorithms, guiding clinical studies, and out-ruling ineffective control scenarios in a cost-effective manner. Thus computer simulation testing of closed-loop control algorithms is regarded as a prerequisite to clinical trials of the artificial pancreas. In this paper, we present a system for in silico testing of control algorithms that has three principal components: (1) a large cohort of n=300 simulated "subjects" (n=100 adults, 100 adolescents, and 100 children) based on real individuals' data and spanning the observed variability of key metabolic parameters in the general population of people with T1DM; (2) a simulator of CGM sensor errors representative of Freestyle Navigator™, Guardian RT, or Dexcom™ STS™, 7-day sensor; and (3) a simulator of discrete s.c. insulin delivery via OmniPod Insulin Management System or Deltec Cozmo(®) insulin pump. The system has been shown to represent adequate glucose fluctuations in T1DM observed during meal challenges, and has been accepted by the Food and Drug Administration as a substitute to animal trials in the preclinical testing of closed-loop control strategies. © Diabetes Technology Society

Performance evaluation of a conformal thermal monitoring sheet (TMS) sensor array for measurement of surface temperature distributions during superficial hyperthermia treatments

PubMed Central

Arunachalam, K.; Maccarini, P.; Juang, T.; Gaeta, C.; Stauffer, P. R.

2009-01-01

Purpose This paper presents a novel conformal thermal monitoring sheet sensor array with differential thermal sensitivity for measuring temperature distributions over large surface areas. Performance of the sensor array is evaluated in terms of thermal accuracy, mechanical stability and conformity to contoured surfaces, probe self heating under irradiation from microwave and ultrasound hyperthermia sources, and electromagnetic field perturbation. Materials and Methods A prototype TMS with 4×4 array of fiberoptic sensors embedded between two flexible and thermally conducting polyimide films was developed as an alternative to the standard 1-2 mm diameter plastic catheter based probes used in clinical hyperthermia. Computed tomography images and bending tests were performed to evaluate the conformability and mechanical stability respectively. Irradiation and thermal barrier tests were conducted and thermal response of the prototype was compared with round cross-sectional clinical probes. Results Bending and conformity tests demonstrated higher flexibility, dimensional stability and close conformity to human torso. Minimal perturbation of microwave fields and low probe self heating was observed when irradiated with 915MHz microwave and 3.4MHz ultrasound sources. The transient and steady state thermal responses of the TMS array were superior compared to the clinical probes. Conclusions A conformal TMS sensor array with improved thermal sensitivity and dimensional stability was investigated for real-time skin temperature monitoring. This fixed-geometry, body-conforming array of thermal sensors allows fast and accurate characterization of two-dimensional temperature distributions over large surface areas. The prototype TMS demonstrates significant advantages over clinical probes for characterizing skin temperature distributions during hyperthermia treatments of superficial tissue disease. PMID:18465416

Integration of outpatient infectious diseases clinic pharmacy services and specialty pharmacy services for patients with HIV infection.

PubMed

Gilbert, Elise M; Gerzenshtein, Lana

2016-06-01

The integration of specialty pharmacy services and existing outpatient clinical pharmacy services within an infectious diseases (ID) clinic to optimize the care of patients with human immunodeficiency virus (HIV) infection is described. The management of HIV-infected patients is a highly specialized area of practice, often requiring use of complex medication regimens for reduction of HIV-associated morbidity and mortality prophylaxis and treatment of opportunistic infections, and prevention of HIV transmission. To maximize the effectiveness and safety of treatment with antiretroviral agents and associated pharmacotherapies, an interdisciplinary team is often involved in patient care. At Chicago-based Northwestern Medicine (NM), the outpatient ID clinic has long worked with an interdisciplinary care team including physicians, clinical pharmacists, nurses, and social workers to care for patients with HIV infection. In April 2014, specialty pharmacy services for patients with HIV infection were added to the NM ID clinic's care model to help maintain continuity of care and enhance patient follow-up. The care model includes well-defined roles for clinical pharmacists, pharmacy residents and students on rotation, and licensed pharmacy technicians. Specialty pharmacy services, including medication education, prescription fulfillment, assistance with medication access (e.g., navigation of financial assistance programs, completion of prior-authorization requests), and treatment monitoring, allow for closed-loop medication management of the HIV-infected patient population. Integration of specialty pharmacy services with the interdisciplinary care provided in the outpatient NM ID clinic has enhanced continuity of care for patients with HIV infection in terms of prescription filling, medication counseling, and adherence monitoring. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

[Syndrome of emotional burnout among women-physicians elderly].

PubMed

Myakotnykh, V S; Borovkova, T A

2017-01-01

The article presents the results of a comparative study of clinical symptoms of syndrome of emotional burnout among 84 working in the specialty physician of older women and 48 officially ceasing operations in this specialty. The findings suggest that burnout can take place among representatives of older age and more it is continued, provided professional activities. The cessation of the work activities leads to stress, often with the subsequent development post-traumatic stress disorder and stress-induced diseases. However in this case the clinical symptoms of the syndrome of emotional burnout, does not disappear, but only happens their clinical transformation attach various psychosomatic disorders. Thus, the elderly, suffering the syndrome of emotional burnout, are at high risk group with regard to the formation and development of diseases, associated with stress and require close monitoring in the framework of the compulsory program of medical examination.

Assessing the quality of radiographic processing in general dental practice.

PubMed

Thornley, P H; Stewardson, D A; Rout, P G J; Burke, F J T

2006-05-13

To determine if a commercial device (Vischeck) for monitoring film processing quality was a practical option in general dental practice, and to assess processing quality among a group of GDPs in the West Midlands with this device. Clinical evaluation. General dental practice, UK, 2004. Ten GDP volunteers from a practice based research group processed Vischeck strips (a) when chemicals were changed, (b) one week later, and (c) immediately before the next change of chemicals. These were compared with strips processed under ideal conditions. Additionally, a series of duplicate radiographs were produced and processed together with Vischeck strips in progressively more dilute developer solutions to compare the change in radiograph quality assessed clinically with that derived from the Vischeck. The Vischeck strips suggested that at the time chosen for change of processing chemicals, eight dentists had been processing films well beyond the point indicated for replacement. Solutions were changed after a wide range of time periods and number of films processed. The calibration of the Vischeck strip correlated closely to a clinical assessment of acceptable film quality. Vischeck strips are a useful aid to monitoring processing quality in automatic developers in general dental practice. Most of this group of GDPs were using chemicals beyond the point at which diagnostic yield would be affected.

Wireless Technology to Track Surgical Patients after Discharge: A Pilot Study.

PubMed

Dawes, Aaron J; Reardon, Sarah; Chen, Victor L; Kaiser, William; Russell, Marcia M; Ko, Clifford Y; Lin, Anne Y

2015-10-01

Failure to detect changes in patients' postoperative health status increases the risk of adverse outcomes, including complications and readmission. We sought to design and implement a real-time surveillance system for postoperative colorectal surgery patients using wireless health technology. Participants were assigned a preprogrammed tablet computer during their inpatient hospitalization, and asked to complete a daily survey regarding their postoperative health status until their first clinic visit. Surveys were transmitted wirelessly to a secure database for review. As a pilot study, we report on our first 20 consecutively enrolled patients, monitored for 265 patient days. Overall compliance was 63 per cent (data available for 166 of the 265 days), but varied by patient from 26 to 100 per cent. We were able to reliably collect basic data on postoperative health status as well as patient-reported outcomes not previously captured by standard assessment techniques. Qualitative data suggest that the experience strengthened patients' relationship with their surgeon and aided in their recovery. Postoperative remote monitoring is feasible, and provides more detailed and complete information to the clinical team. Wireless health technology represents an opportunity to close the information gap between discharge and first clinic visit, and, eventually, to improve patient-provider communication, increase patient satisfaction, and prevent unnecessary readmissions.

Intraoperative seizures during craniotomy under general anesthesia.

PubMed

Howe, John; Lu, Xiaoying; Thompson, Zoe; Peterson, Gordon W; Losey, Travis E

2016-05-01

An acute symptomatic seizure is a clinical seizure occurring at the time of or in close temporal association with a brain insult. We report an acute symptomatic seizure occurring during a surgical procedure in a patient who did not have a prior history of epilepsy and who did not have a lesion associated with an increased risk of epilepsy. To characterize the incidence and clinical features of intraoperative seizures during craniotomy under general anesthesia, we reviewed cases where continuous EEG was acquired during craniotomy. Records of 400 consecutive cases with propofol as general anesthesia during craniotomy were reviewed. Demographic data, indication for surgery, clinical history, history of prior seizures, duration of surgery and duration of burst suppression were recorded. Cases where seizures were observed were analyzed in detail. Two out of 400 patients experienced intraoperative seizures, including one patient who appeared to have an acute symptomatic seizure related to the surgical procedure itself and a second patient who experienced two seizures likely related to an underlying diagnosis of epilepsy. This is the first report of an acute symptomatic seizure secondary to a neurosurgical procedure. Overall, 0.5% of patients monitored experienced seizures, indicating that intraoperative seizures are rare, and EEG monitoring during craniotomies is of low yield in detecting seizures. Copyright © 2016. Published by Elsevier Ltd.

Remote monitoring of the progression of primary pneumonic plague in Brown Norway rats in high-capacity, high-containment housing

PubMed Central

Coate, Eric A.; Kocsis, Andrew G.; Peters, Kristen N.; Anderson, Paul E.; Ellersieck, Mark R.; Fine, Deborah M.; Anderson, Deborah M.

2014-01-01

Development of new vaccines, diagnostics and therapeutics for biodefense or other relatively rare infectious diseases is hindered by the lack of naturally occurring human disease on which to conduct clinical trials of efficacy. To overcome this experimental gap, the U.S. Food and Drug Administration established the Animal Rule, in which efficacy testing in two well-characterized animal models that closely resemble human disease may be accepted in lieu of large scale clinical trials for diseases with limited natural human incidence. In this report, we evaluated the Brown Norway rat as a model for pneumonic plague and describe the natural history of clinical disease following inhalation exposure to Yersinia pestis. In high-capacity, high-containment housing, we monitored temperature, activity, heart rate and rhythm by capturing electronic impulses transmitted from abdominal telemeter implants. Using this system, we show that reduced activity and development of fever are sensitive indications of disease progression. Furthermore, we identified heart arrhythmias as contributing factors to the rapid progression to lethality following the fever response. Together these data validate the Brown Norway rat as an experimental model for human pneumonic plague and provide new insight that may ultimately lead to novel approaches in post-exposure treatment of this devastating infection. PMID:24719212

Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial.

PubMed

Bartl, Christoph; Stengel, Dirk; Bruckner, Thomas; Rossion, Inga; Luntz, Steffen; Seiler, Christoph; Gebhard, Florian

2011-03-22

Fractures of the distal radius represent the most common fracture in elderly patients, and often indicate the onset of symptomatic osteoporosis. A variety of treatment options is available, including closed reduction and plaster casting, K-wire-stabilization, external fixation and open reduction and internal fixation (ORIF) with volar locked plating. The latter is widely promoted by clinicians and hardware manufacturers. Closed reduction and cast stabilization for six weeks is a simple, convenient, and ubiquitously available intervention. In contrast, ORIF requires hospitalization, but allows for functional rehabilitation.Given the lack of randomized controlled trials, it remains unclear whether ORIF leads to better functional outcomes one year after injury than closed reduction and casting. ORCHID (Open reduction and internal fixation versus casting for highly comminuted intra-articular fractures of the distal radius) is a pragmatic, randomized, multi-center, clinical trial with two parallel treatment arms. It is planned to include 504 patients in 15 participating centers throughout Germany over a three-year period. Patients are allocated by a central web-based randomization tool.The primary objective is to determine differences in the Short Form 36 (SF-36) Physical Component Score (PCS) between volar locked plating and closed reduction and casting of intraarticular, comminuted distal radius fractures in patients > 65 years of age one year after the fracture. Secondary outcomes include differences in other SF-36 dimensions, the EuroQol-5D questionnaire, the Disability of the Arm, Shoulder, and Hand (DASH) instrument. Also, the range of motion in the affected wrist, activities of daily living, complications (including secondary ORIF and revision surgery), as well as serious adverse events will be assessed. Data obtained during the trial will be used for later health-economic evaluations. The trial architecture involves a central statistical unit, an independent monitoring institute, and a data safety monitoring board. Following approval by the institutional review boards of all participating centers, conduct and reporting will strictly adhere to national and international rules, regulations, and recommendations (e.g., Good Clinical Practice, data safety laws, and EQUATOR/CONSORT proposals). To our knowledge, ORCHID is the first multicenter RCT designed to assess quality of life and functional outcomes following operative treatment compared to conservative treatment of complex, intra-articular fractures of the distal radius in elderly patients. The results are expected to influence future treatment recommendations and policies on an international level. ISRCTN: ISRCTN76120052 Registration date: 31.07.2008; Randomization of first patient: 15.09.2008.

Genesis of the Mechanical Heart Valves' Ultrasonic Closing Clicks

NASA Astrophysics Data System (ADS)

Hasegawa, Jun; Kobayashi, Kenji

A new in vitro experimental tool was developed to study the mechanism of the ultrasonic closing clicks' genesis of mechanical heart valves. Since the newly developed tester adopted compressed air flow directly instead of the blood analog fluid to drive the mechanical heart valve, it is not possibe to generate any cavitation. Closing clicks were measured with a small accelerometer at the surface of the valve holder made of silicone rubber. Ultrasonic closing clicks as well as audible closing clicks, similar to those measured clinically, could be observed using this setup. Thus, it was confirmed that the ultrasonic closing clicks can be generated without the existence of cavitation. Simultaneous measurements of the valve motion were made with a high-speed video camera, and the analysis of the video frames and clicks showed that higher frequency signal components of more than 50kHz could be generated only at the instant of the closure, which means the collision of the occluder with the housing. Eighteen miniature accelerometers with an area of one square millimeter were developed and stuck on the housing to monitor the distribution of the housing vibrations in detail, and it was found that the vibrations correspond to the ultrasonic closing clicks propagated from the valve stop: the collision point of the occluder with the housing. This fact indicated that the generation of ultrasonic closing clicks are limited to the small area of the collision. From those results, it was concluded that the major origin of the ultrasonic closing clicks' genesis should be the collision of the occluder with the housing.

Studies on a wearable, electronic, transdermal alcohol sensor.

PubMed

Swift, R M; Martin, C S; Swette, L; LaConti, A; Kackley, N

1992-08-01

The measurement of alcohol consumption over long time periods is important for monitoring treatment outcome and for research applications. Giner, Inc. has developed a wearable device that senses ethanol vapor at the surface of the skin, using an electrochemical cell that produces a continuous current signal proportional to ethanol concentration. A thermistor monitors continuous contact of the sensor with the skin, and a data-acquisition/logic circuit stores days of data recorded at 2- to 5-min intervals. Testing of this novel ethanol sensor/recorder was conducted on nonalcoholic human subjects consuming known quantities of ethanol and on intoxicated alcoholic subjects. The transdermal sensor signal closely follows the pattern of the blood alcohol concentration curve, although with a delay. This paper describes the concept of electrochemical ethanol measurement and presents some of the clinical data collected in support of the sensor/recorder development.

Congenital Upper Eyelid Coloboma: Clinical and Surgical Management

PubMed Central

Ortega Molina, José María; Mora Horna, Eduardo Ramón; Salgado Miranda, Andrés David; Rubio, Rosa; Solans Pérez de Larraya, Ana; Salcedo Casillas, Guillermo

2015-01-01

Purpose. The goal was to describe our experience in the surgical management and treatment of four patients with congenital upper eyelid colobomas. Methods. A descriptive, observational, retrospective study was performed including patients with congenital eyelid colobomas referred to Asociación para Evitar la Ceguera en México I.A.P. “Dr. Luis Sánchez Bulnes” between 2004 and 2014 and assessed by the Oculoplastics and Orbit Service. Results. The four cases required surgical treatment of the eyelid defects before one year of age and their evolution was monitored from the time of referral to the present day. One of the patients needed a second surgical procedure to repair the eyelid defect and correct the strabismus. Conclusions. Eyelid colobomas are a potential threat to vision at an early age, which requires close monitoring of the visual development of patients. PMID:26366313

Congenital Upper Eyelid Coloboma: Clinical and Surgical Management.

PubMed

Ortega Molina, José María; Mora Horna, Eduardo Ramón; Salgado Miranda, Andrés David; Rubio, Rosa; Solans Pérez de Larraya, Ana; Salcedo Casillas, Guillermo

2015-01-01

Purpose. The goal was to describe our experience in the surgical management and treatment of four patients with congenital upper eyelid colobomas. Methods. A descriptive, observational, retrospective study was performed including patients with congenital eyelid colobomas referred to Asociación para Evitar la Ceguera en México I.A.P. "Dr. Luis Sánchez Bulnes" between 2004 and 2014 and assessed by the Oculoplastics and Orbit Service. Results. The four cases required surgical treatment of the eyelid defects before one year of age and their evolution was monitored from the time of referral to the present day. One of the patients needed a second surgical procedure to repair the eyelid defect and correct the strabismus. Conclusions. Eyelid colobomas are a potential threat to vision at an early age, which requires close monitoring of the visual development of patients.

Magnetic Resonance Imaging in Nondependent Pacemaker Patients with Pacemakers and Defibrillators with a Nearly Depleted Battery.

PubMed

Okamura, Hideo; Padmanabhan, Deepak; Watson, Robert E; Dalzell, Connie; Acker, Nancy; Jondal, Mary; Romme, Abby L; Cha, Yong-Mei; Asirvatham, Samuel J; Felmlee, Joel P; Friedman, Paul A

2017-05-01

Magnetic resonance imaging (MRI) in patients with non-MRI-conditional cardiac implantable electronic devices (CIEDs) has been shown to be safe when performed under closely monitored protocols. However, the safety of MRI in patients with devices with a nearly depleted battery has not been reported. Prospective data were collected between January 2008 and May 2015 in patients with non-MRI-conditional CIEDs undergoing clinically indicated MRI under institutional protocol. Patients who were pacemaker dependent were excluded. Patients whose devices were at elective replacement indicator (ERI) at the time of MRI or close to ERI (ERI or replacement for battery depletion within 3 months of scan) were identified through database review and analyzed for clinical events. MRI scans (n = 569) were performed in 442 patients. Of these, we identified 13 scans performed with a nearly depleted battery in nine patients. All scans with implantable cardioverter defibrillators (ICDs, n = 9) were uneventful. However, two scans with pacemakers close to ERI resulted in a power-on-reset (PoR) event. One scan with a pacemaker close to ERI that was programmed to DOO mode reached ERI during MRI and automatically changed to VVI mode. Additionally, one scan with a pacemaker at ERI did not allow programming. All pacemakers with events were implanted before 2005. Patients with pacemakers and ICDs with a nearly depleted battery can safely undergo MRI when patients are not pacemaker dependent. Attention should be paid because old devices can result in PoR or ERI during MRI, which may lead to oversensing and inhibition of pacing. © 2017 Wiley Periodicals, Inc.

Fault Detection and Safety in Closed-Loop Artificial Pancreas Systems

PubMed Central

2014-01-01

Continuous subcutaneous insulin infusion pumps and continuous glucose monitors enable individuals with type 1 diabetes to achieve tighter blood glucose control and are critical components in a closed-loop artificial pancreas. Insulin infusion sets can fail and continuous glucose monitor sensor signals can suffer from a variety of anomalies, including signal dropout and pressure-induced sensor attenuations. In addition to hardware-based failures, software and human-induced errors can cause safety-related problems. Techniques for fault detection, safety analyses, and remote monitoring techniques that have been applied in other industries and applications, such as chemical process plants and commercial aircraft, are discussed and placed in the context of a closed-loop artificial pancreas. PMID:25049365

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

Non-Invasive Monitoring of Cardiac Output in Critical Care Medicine.

PubMed

Nguyen, Lee S; Squara, Pierre

2017-01-01

Critically ill patients require close hemodynamic monitoring to titrate treatment on a regular basis. It allows administering fluid with parsimony and adjusting inotropes and vasoactive drugs when necessary. Although invasive monitoring is considered as the reference method, non-invasive monitoring presents the obvious advantage of being associated with fewer complications, at the expanse of accuracy, precision, and step-response change. A great many methods and devices are now used over the world, and this article focuses on several of them, providing with a brief review of related underlying physical principles and validation articles analysis. Reviewed methods include electrical bioimpedance and bioreactance, respiratory-derived cardiac output (CO) monitoring technique, pulse wave transit time, ultrasound CO monitoring, multimodal algorithmic estimation, and inductance thoracocardiography. Quality criteria with which devices were reviewed included: accuracy (closeness of agreement between a measurement value and a true value of the measured), precision (closeness of agreement between replicate measurements on the same or similar objects under specified conditions), and step response change (delay between physiological change and its indication). Our conclusion is that the offer of non-invasive monitoring has improved in the past few years, even though further developments are needed to provide clinicians with sufficiently accurate devices for routine use, as alternative to invasive monitoring devices.

AeroVironment's Jim Daley, Rik Meininger, Derek Lisoski and Wyatt Sadler (clockwise from bottom left) closely monitor systems testing of the Pathfinder-Plus.

NASA Image and Video Library

2004-09-17

AeroVironment's test director Jim Daley, backup pilot Rik Meininger, stability and controls engineer Derek Lisoski and pilot Wyatt Sadler (clockwise from bottom left) closely monitor systems testing of the Pathfinder-Plus solar aircraft from the control station.

An evaluation of the following too closely monitor system on a four-lane undivided highway : interim report.

DOT National Transportation Integrated Search

1976-01-01

The FOLLOWING TOO CLOSELY (FTC) MONITOR system is an experimental device designed to measure vehicle gaps at a point along the highway and to advise the motorist, by means of a flashing message on a sign, that he is following the car in front of him ...

Parametric fate and transport profiling for selective groundwater monitoring at closed landfills: a case study.

PubMed

Sizirici, Banu; Tansel, Berrin

2015-04-01

Monitoring contaminant concentrations in groundwater near closed municipal solid waste landfills requires long term monitoring program which can require significant investment for monitoring efforts. The groundwater monitoring data from a closed landfill in Florida was analyzed to reduce the monitoring efforts. The available groundwater monitoring data (collected over 20 years) were analyzed (i.e., type, concentration and detection level) to identify the trends in concentrations of contaminants and spatial mobility characteristics of groundwater (i.e., groundwater direction, retardation characteristics of contaminants, groundwater well depth, subsoil characteristics), to identify critical monitoring locations. Among the 7 groundwater monitoring well clusters (totaling 22 wells) in landfill, the data from two monitoring well clusters (totaling 7 wells) located along direction of groundwater flow showed similarities (the highest concentrations and same contaminants). These wells were used to assess the transport characteristics of the contaminants. Some parameters (e.g., iron, sodium, ammonia as N, chlorobenzene, 1,4-dichlorobenzene) showed decreasing trends in the groundwater due to soil absorption and retardation. Metals were retarded by ion exchange and their concentration increased by depth indicating soil reached breakthrough over time. Soil depth did not have a significant effect on the concentrations of volatile organic contaminants. Based on the analyses, selective groundwater monitoring modifications were developed for effective monitoring to acquire data from the most critical locations which may be impacted by leachate mobility. The adjustments in the sampling strategy reduced the amount of data collected by as much as 97.7% (i.e., total number of parameters monitored). Effective groundwater sampling strategies can save time, effort and monitoring costs while improving the quality of sample handling and data analyses for better utilization of post closure monitoring funds. Copyright © 2015 Elsevier Ltd. All rights reserved.

Closed-Loop- and Decision-Assist-Guided Fluid Therapy of Human Hemorrhage.

PubMed

Hundeshagen, Gabriel; Kramer, George C; Ribeiro Marques, Nicole; Salter, Michael G; Koutrouvelis, Aristides K; Li, Husong; Solanki, Daneshvari R; Indrikovs, Alexander; Seeton, Roger; Henkel, Sheryl N; Kinsky, Michael P

2017-10-01

We sought to evaluate the efficacy, efficiency, and physiologic consequences of automated, endpoint-directed resuscitation systems and compare them to formula-based bolus resuscitation. Experimental human hemorrhage and resuscitation. Clinical research laboratory. Healthy volunteers. Subjects (n = 7) were subjected to hemorrhage and underwent a randomized fluid resuscitation scheme on separate visits 1) formula-based bolus resuscitation; 2) semiautonomous (decision assist) fluid administration; and 3) fully autonomous (closed loop) resuscitation. Hemodynamic variables, volume shifts, fluid balance, and cardiac function were monitored during hemorrhage and resuscitation. Treatment modalities were compared based on resuscitation efficacy and efficiency. All approaches achieved target blood pressure by 60 minutes. Following hemorrhage, the total amount of infused fluid (bolus resuscitation: 30 mL/kg, decision assist: 5.6 ± 3 mL/kg, closed loop: 4.2 ± 2 mL/kg; p < 0.001), plasma volume, extravascular volume (bolus resuscitation: 17 ± 4 mL/kg, decision assist: 3 ± 1 mL/kg, closed loop: -0.3 ± 0.3 mL/kg; p < 0.001), body weight, and urinary output remained stable under decision assist and closed loop and were significantly increased under bolus resuscitation. Mean arterial pressure initially decreased further under bolus resuscitation (-10 mm Hg; p < 0.001) and was lower under bolus resuscitation than closed loop at 20 minutes (bolus resuscitation: 57 ± 2 mm Hg, closed loop: 69 ± 4 mm Hg; p = 0.036). Colloid osmotic pressure (bolus resuscitation: 19.3 ± 2 mm Hg, decision assist, closed loop: 24 ± 0.4 mm Hg; p < 0.05) and hemoglobin concentration were significantly decreased after bolus fluid administration. We define efficacy of decision-assist and closed-loop resuscitation in human hemorrhage. In comparison with formula-based bolus resuscitation, both semiautonomous and autonomous approaches were more efficient in goal-directed resuscitation of hemorrhage. They provide favorable conditions for the avoidance of over-resuscitation and its adverse clinical sequelae. Decision-assist and closed-loop resuscitation algorithms are promising technological solutions for constrained environments and areas of limited resources.

A high- Tc SQUID-based sensor head cooled by a Joule-Thomson cryocooler

NASA Astrophysics Data System (ADS)

Rijpma, A. P.; ter Brake, H. J. M.; de Vries, E.; Nijhof, N.; Holland, H. J.; Rogalla, H.

2002-08-01

The goal of the so-called FHARMON project is to develop a high- Tc SQUID-based magnetometer system for the measurement of fetal heart activity in standard clinical environments. To lower the threshold for the application of this fetal heart monitor, it should be simple to operate. It is, therefore, advantageous to replace the liquid cryogen bath by a closed-cycle refrigerator. For this purpose, we selected a mixed-gas Joule-Thomson cooler; the APD Cryotiger ©. Because of its magnetic interference, the compressor of this closed-cycle cooler will be placed at a distance of ≈2 m from the actual sensor, which is an axial second order gradiometer. The gradiometer is formed by three magnetometers placed on an alumina cylinder, which is connected to the cold head of the cooler. This paper describes the sensor head in detail and reports on test experiments.

Closed loop tracked Doppler optical coherence tomography based heart monitor for the Drosophila melanogaster larvae.

PubMed

Zurauskas, Mantas; Bradu, Adrian; Ferguson, Daniel R; Hammer, Daniel X; Podoleanu, Adrian

2016-03-01

This paper presents a novel instrument for biosciences, useful for studies of moving embryos. A dual sequential imaging/measurement channel is assembled via a closed-loop tracking architecture. The dual channel system can operate in two regimes: (i) single-point Doppler signal monitoring or (ii) fast 3-D swept source OCT imaging. The system is demonstrated for characterizing cardiac dynamics in Drosophila melanogaster larva. Closed loop tracking enables long term in vivo monitoring of the larvae heart without anesthetic or physical restraint. Such an instrument can be used to measure subtle variations in the cardiac behavior otherwise obscured by the larvae movements. A fruit fly larva (top) was continuously tracked for continuous remote monitoring. A heartbeat trace of freely moving larva (bottom) was obtained by a low coherence interferometry based doppler sensing technique. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities.

PubMed

Rodbard, David

2016-02-01

Continuous glucose monitoring (CGM) provides information unattainable by intermittent capillary blood glucose, including instantaneous real-time display of glucose level and rate of change of glucose, alerts and alarms for actual or impending hypo- and hyperglycemia, "24/7" coverage, and the ability to characterize glycemic variability. Progressively more accurate and precise, reasonably unobtrusive, small, comfortable, user-friendly devices connect to the Internet to share information and are sine qua non for a closed-loop artificial pancreas. CGM can inform, educate, motivate, and alert people with diabetes. CGM is medically indicated for patients with frequent, severe, or nocturnal hypoglycemia, especially in the presence of hypoglycemia unawareness. Surprisingly, despite tremendous advances, utilization of CGM has remained fairly limited to date. Barriers to use have included the following: (1) lack of Food and Drug Administration approval, to date, for insulin dosing ("nonadjuvant use") in the United States and for use in hospital and intensive care unit settings; (2) cost and variable reimbursement; (3) need for recalibrations; (4) periodic replacement of sensors; (5) day-to-day variability in glycemic patterns, which can limit the predictability of findings based on retrospective, masked "professional" use; (6) time, implicit costs, and inconvenience for uploading of data for retrospective analysis; (7) lack of fair and reasonable reimbursement for physician time; (8) inexperience and lack of training of physicians and other healthcare professionals regarding interpretation of CGM results; (9) lack of standardization of software methods for analysis of CGM data; and (10) need for professional medical organizations to develop and disseminate additional clinical practice guidelines regarding the role of CGM. Ongoing advances in technology and clinical research have addressed several of these barriers. Use of CGM in conjunction with an insulin pump with automated suspension of insulin infusion in response to actual observed or predicted hypoglycemia, as well as progressive refinement of closed-loop systems, is expected to dramatically enhance the clinical utility and utilization of CGM.

Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities

PubMed Central

2016-01-01

Abstract Continuous glucose monitoring (CGM) provides information unattainable by intermittent capillary blood glucose, including instantaneous real-time display of glucose level and rate of change of glucose, alerts and alarms for actual or impending hypo- and hyperglycemia, “24/7” coverage, and the ability to characterize glycemic variability. Progressively more accurate and precise, reasonably unobtrusive, small, comfortable, user-friendly devices connect to the Internet to share information and are sine qua non for a closed-loop artificial pancreas. CGM can inform, educate, motivate, and alert people with diabetes. CGM is medically indicated for patients with frequent, severe, or nocturnal hypoglycemia, especially in the presence of hypoglycemia unawareness. Surprisingly, despite tremendous advances, utilization of CGM has remained fairly limited to date. Barriers to use have included the following: (1) lack of Food and Drug Administration approval, to date, for insulin dosing (“nonadjuvant use”) in the United States and for use in hospital and intensive care unit settings; (2) cost and variable reimbursement; (3) need for recalibrations; (4) periodic replacement of sensors; (5) day-to-day variability in glycemic patterns, which can limit the predictability of findings based on retrospective, masked “professional” use; (6) time, implicit costs, and inconvenience for uploading of data for retrospective analysis; (7) lack of fair and reasonable reimbursement for physician time; (8) inexperience and lack of training of physicians and other healthcare professionals regarding interpretation of CGM results; (9) lack of standardization of software methods for analysis of CGM data; and (10) need for professional medical organizations to develop and disseminate additional clinical practice guidelines regarding the role of CGM. Ongoing advances in technology and clinical research have addressed several of these barriers. Use of CGM in conjunction with an insulin pump with automated suspension of insulin infusion in response to actual observed or predicted hypoglycemia, as well as progressive refinement of closed-loop systems, is expected to dramatically enhance the clinical utility and utilization of CGM. PMID:26784127

Italian Contributions to the Development of Continuous Glucose Monitoring Sensors for Diabetes Management

PubMed Central

Sparacino, Giovanni; Zanon, Mattia; Facchinetti, Andrea; Zecchin, Chiara; Maran, Alberto; Cobelli, Claudio

2012-01-01

Monitoring glucose concentration in the blood is essential in the therapy of diabetes, a pathology which affects about 350 million people around the World (three million in Italy), causes more than four million deaths per year and consumes a significant portion of the budget of national health systems (10% in Italy). In the last 15 years, several sensors with different degree of invasiveness have been proposed to monitor glycemia in a quasi-continuous way (up to 1 sample/min rate) for relatively long intervals (up to 7 consecutive days). These continuous glucose monitoring (CGM) sensors have opened new scenarios to assess, off-line, the effectiveness of individual patient therapeutic plans from the retrospective analysis of glucose time-series, but have also stimulated the development of innovative on-line applications, such as hypo/hyper-glycemia alert systems and artificial pancreas closed-loop control algorithms. In this review, we illustrate some significant Italian contributions, both from industry and academia, to the growth of the CGM sensors research area. In particular, technological, algorithmic and clinical developments performed in Italy will be discussed and put in relation with the advances obtained in the field in the wider international research community. PMID:23202020

Italian contributions to the development of continuous glucose monitoring sensors for diabetes management.

PubMed

Sparacino, Giovanni; Zanon, Mattia; Facchinetti, Andrea; Zecchin, Chiara; Maran, Alberto; Cobelli, Claudio

2012-10-12

Monitoring glucose concentration in the blood is essential in the therapy of diabetes, a pathology which affects about 350 million people around the World (three million in Italy), causes more than four million deaths per year and consumes a significant portion of the budget of national health systems (10% in Italy). In the last 15 years, several sensors with different degree of invasiveness have been proposed to monitor glycemia in a quasi-continuous way (up to 1 sample/min rate) for relatively long intervals (up to 7 consecutive days). These continuous glucose monitoring (CGM) sensors have opened new scenarios to assess, off-line, the effectiveness of individual patient therapeutic plans from the retrospective analysis of glucose time-series, but have also stimulated the development of innovative on-line applications, such as hypo/hyper-glycemia alert systems and artificial pancreas closed-loop control algorithms. In this review, we illustrate some significant Italian contributions, both from industry and academia, to the growth of the CGM sensors research area. In particular, technological, algorithmic and clinical developments performed in Italy will be discussed and put in relation with the advances obtained in the field in the wider international research community.

The prognostic reliability of intracranial pressure monitoring and MRI data in severe traumatic brain injury.

PubMed

Woischneck, Dieter; Kapapa, Thomas

2017-02-01

The predictive quality of intracranial pressure (ICP) monitoring has for many years been a matter of debate. We correlate ICP data comparing MRI data with the outcome after severe traumatic brain injury to evaluate their prognostic potency. This study compares the results of ICP monitoring, MRI, coma duration and outcome according to Glasgow Outcome Scale obtained in 32 patients having suffered severe TBI. Level of significance was set to p≤0.05 in statistical tests. The MRI results were closely correlated with coma duration and Glasgow Outcome Scale, but the ICP measurements were not. With the exception of severe, bipontine lesions, there is no other region of the brain in which increased evidence of traumatogenic lesions emerges as the intracranial pressure rises. Just bipontine lesions that proof to be infaust correlate with elevated ICP values. ICP monitoring does not allow individual prognostic conclusions to be made. Implantation of an intracranial pressure sensor alone for making a prognostic estimate is not advisable. The use of intracranial pressure measurements in the retrospective appraisal of disease progress is highly problematic. However, MRI diagnostic in patients with severe TBI improves prognostic potency of clinical parameters. Copyright © 2016 Elsevier Inc. All rights reserved.

Glucose-responsive insulin delivery for type 1 diabetes: The artificial pancreas story.

PubMed

Bally, Lia; Thabit, Hood; Hovorka, Roman

2018-06-15

Insulin replacement therapy is integral to the management of type 1 diabetes, which is characterised by absolute insulin deficiency. Optimal glycaemic control, as assessed by glycated haemoglobin, and avoidance of hyper- and hypoglycaemic excursions have been shown to prevent diabetes-related complications. Insulin pump use has increased considerably over the past decade with beneficial effects on glycaemic control, quality of life and treatment satisfaction. The advent and progress of ambulatory glucose sensor technology has enabled continuous glucose monitoring based on real-time glucose levels to be integrated with insulin therapy. Low glucose and predictive low glucose suspend systems are currently used in clinical practice to mitigate against hypoglycaemia, and provide the first step towards feedback glucose control. The more advanced technology approach, an artificial pancreas or a closed-loop system, gradually increases and decreases insulin delivery in a glucose-responsive fashion to mitigate against hyper- and hypoglycaemia. Randomised outpatient clinical trials over the past 5 years have demonstrated the feasibility, safety and efficacy of the approach, and the recent FDA approval of the first single hormone closed-loop system establishes a new standard of care for people with type 1 diabetes. Copyright © 2017 Elsevier B.V. All rights reserved.

Monitored plutonium aerosols at a soil cleanup site on Johnston Atoll

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

Shinn, J.H.; Fry, C.O.; Johnson, J.S.

1996-01-23

Suspended plutonium in air was monitored for four periods near the operation of a stationary sorting system used to {open_quotes}mine{close_quotes} contaminated soil on Johnston Atoll. The monitoring periods were 14 October-14 November 1992, 20 October-15 November 1993, 16 August-3 November 1994, and 17 February-27 February 1995. Pairs of high volume air samplers were located at each of four locations of the process stream: the {open_quotes}spoils pile{close_quotes} that was the feedstock, the {open_quotes}plant area{close_quotes} near the hot soil gate of the sorter, the {open_quotes}clean pile{close_quotes} conveyer area where sorted clean soil was moved, and the {open_quotes}oversize soil{close_quotes} crushing area. These locationsmore » were monitored only during the working hours, while air monitoring was also done at an upwind, {open_quotes}background{close_quotes} area 24-hours per day. The median concentrations of Pu in {open_quotes}workplace{close_quotes} air (combined spoils pile, plant area, and clean pile sites) in 1992 was 397 aCi/m{sup 3} (15 {mu}Bq/m{sup 3}), but increased to median values of 23000 aCi/m{sup 3} (852 {mu}Bq/m{sup 3}) in August-November 1994 and 29800 aCi/m{sup 3} (1100 {mu}Bq/m{sup 3}) in February 1995. The highest median value at the worksites (29800 aCi/m{sup 3}) was more than 200 times lower than the regulatory level. The highest observed value was 84200 aCi/m{sup 3} at the spoils pile site, and this was more than 70 times lower than the regulatory level. The conclusion was that, in spite of the dusty environment, and the increased level of specific activity, we did not find that the soil processing posed any significant risk to workers during the observation periods 1992-1995.« less

Risks, Management, and Monitoring of Combination Opioid, Benzodiazepines, and/or Alcohol Use

PubMed Central

Gudin, Jeffrey A.; Mogali, Shanthi; Jones, Jermaine D.; Comer, Sandra D.

2014-01-01

The concurrent use of opioids, benzodiazepines (BZDs), and/or alcohol poses a formidable challenge for clinicians who manage chronic pain. While the escalating use of opioid analgesics for the treatment of chronic pain and the concomitant rise in opioid-related abuse and misuse are widely recognized trends, the contribution of combination use of BZDs, alcohol, and/or other sedative agents to opioid-related morbidity and mortality is underappreciated, even when these agents are used appropriately. Patients with chronic pain who use opioid analgesics along with BZDs and/or alcohol are at higher risk for fatal/nonfatal overdose and have more aberrant behaviors. Few practice guidelines for BZD treatment are readily available, especially when they are combined clinically with opioid analgesics and other central nervous system–depressant agents. However, coadministration of these agents produces a defined increase in rates of adverse events, overdose, and death, warranting close monitoring and consideration when treating patients with pain. To improve patient outcomes, ongoing screening for aberrant behavior, monitoring of treatment compliance, documentation of medical necessity, and the adjustment of treatment to clinical changes are essential. In this article, we review the prevalence and pharmacologic consequences of BZDs and/or alcohol use among patients with pain on chronic opioid therapy, as well as the importance of urine drug testing, an indispensable tool for therapeutic drug monitoring, which helps to ensure the continued safety of patients. Regardless of risk or known aberrant drug-related behaviors, patients on chronic opioid therapy should periodically undergo urine drug testing to confirm adherence to the treatment plan. PMID:23933900

Clinical evaluation of a simultaneous closed-loop anaesthesia control system for depth of anaesthesia and neuromuscular blockade*.

PubMed

Janda, M; Simanski, O; Bajorat, J; Pohl, B; Noeldge-Schomburg, G F E; Hofmockel, R

2011-12-01

We developed a closed-loop system to control the depth of anaesthesia and neuromuscular blockade using the bispectral index and the electromyogram simultaneously and evaluated the clinical performance of this combined system for general anaesthesia. Twenty-two adult patients were included in this study. Anaesthesia was induced by a continuous infusion of remifentanil at 0.4 μg.kg(-1) .min(-1) (induction dose) and then 0.25 μg.kg(-1) .min(-1) (maintenance dose) and propofol at 2 mg.kg(-1) 3 min later. The combined automatic control was started 2 min after tracheal intubation. The depth of anaesthesia was recorded using bispectral index monitoring using a target value of 40. The target value of neuromuscular blockade, using mivacurium, was a T1/T1(0) twitch height of 10%. The precision of the system was calculated using internationally defined performance parameters. Twenty patients were included in the data analysis. The mean (SD) duration of simultaneous control was 129 (69) min. No human intervention was necessary during the computer-controlled administration of propofol and mivacurium. All patients assessed the quality of anaesthesia as 'good' to 'very good'; there were no episodes of awareness. The mean (SD) median performance error, median absolute performance error and wobble for the control of depth of anaesthesia and for neuromuscular blockade were -0.31 (1.78), 6.76 (3.45), 6.32 (2.93) and -0.38 (1.68), 3.75 (4.83), 3.63 (4.69), respectively. The simultaneous closed-loop system using propofol and mivacurium was able to maintain the target values with a high level of precision in a clinical setting. © 2011 The Authors. Anaesthesia © 2011 The Association of Anaesthetists of Great Britain and Ireland.

[Prescribing monitoring in clinical practice: from enlightened empiricism to rational strategies].

PubMed

Buclin, Thierry; Herzig, Lilli

2013-05-15

Monitoring of a medical condition is the periodic measurement of one or several physiological or biological variables to detect a signal regarding its clinical progression or its response to treatment. We distinguish different medical situations between diagnostic, clinical and therapeutic process to apply monitoring. Many clinical, variables can be used for monitoring, once their intrinsic properties (normal range, critical difference, kinetics, reactivity) and external validity (pathophysiological importance, predictive power for clinical outcomes) are established. A formal conceptualization of monitoring is being developed and should support the rational development of monitoring strategies and their validation through appropriate clinical trials.

Biochemical sensor tubing for point-of-care monitoring of intravenous drugs and metabolites.

PubMed

Choi, Charles J; Wu, Hsin-Yu; George, Sherine; Weyhenmeyer, Jonathan; Cunningham, Brian T

2012-02-07

In medical facilities, there is strong motivation to develop detection systems that can provide continuous analysis of fluids in medical tubing used to either deliver or remove fluids from a patient's body. Possible applications include systems that increase the safety of intravenous (IV) drug injection and point-of-care health monitoring. In this work, we incorporated a surface-enhanced Raman scattering (SERS) sensor comprised of an array of closely spaced metal nanodomes into flexible tubing commonly used for IV drug delivery and urinary catheters. The nanodome sensor was fabricated by a low-cost, large-area process that enables single use disposable operation. As exemplary demonstrations, the sensor was used to kinetically detect promethazine (pain medication) and urea (urinary metabolite) within their clinically relevant concentration ranges. Distinct SERS peaks for each analyte were used to demonstrate separate detection and co-detection of the analytes.

Monitoring of patients with type 2 diabetes and nephropathy in a specialized diabetic nephropathy clinic seems to be beneficial.

PubMed

Vallianou, N; Stratigou, T; Paikopoulou, A; Apostolou, T; Vlassopoulou, B; Tsagarakis, S; Ioannidis, G

2018-04-13

The purpose of this study was to evaluate the outcome of DM2 patients with nephropathy when they are under surveillance of a joined clinic run by endocrinologists & nephrologists. A cohort of 106 patients with DM2, 42-83 years of age, and eGFR < 60 ml/min/m 2 were included. Age, sex, duration of diabetes, duration of attending our clinic, smoking habits, BMI, data regarding ischemic heart disease and induction of hemodialysis, urine albumin excretion (UAE) levels, eGFR (MDRD equation) and values of various biochemical parameters were recorded too. Follow-up period ranged from one to 25 years. Paired samples t-test and non-parametrical Kruskal-Wallis test were used for the analyses of the data. Fifty percent of patients had no further progression, 25.9% improvement, while 24.1% had worsening of the UAE levels. During the follow-up in the joined clinic, there was a smaller than the expected from the medical literature decrease in median eGFR, i.e. 2,3 ml/min/m 2 and a statistically significant improvement in glycosylated hemoglobin levels from 8.0% to 7.4% (p = 0.016). Time in years of follow-up in the joined clinic of our hospital appeared to be the most significant factor in the improvement or stabilization against deterioration of the UAE levels (p = 0.018). Close follow-up of DM2 patients with eGFR < 60 ml/min/m 2 has resulted in a minor annual eGFR decrease. Monitoring of these patients in a specialized diabetic nephropathy clinic is beneficial for this group of patients for delaying the occurrence of end-stage renal disease. Copyright © 2018 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Can composite digital monitoring biomarkers come of age? A framework for utilization.

PubMed

Kovalchick, Christopher; Sirkar, Rhea; Regele, Oliver B; Kourtis, Lampros C; Schiller, Marie; Wolpert, Howard; Alden, Rhett G; Jones, Graham B; Wright, Justin M

2017-12-01

The application of digital monitoring biomarkers in health, wellness and disease management is reviewed. Harnessing the near limitless capacity of these approaches in the managed healthcare continuum will benefit from a systems-based architecture which presents data quality, quantity, and ease of capture within a decision-making dashboard. A framework was developed which stratifies key components and advances the concept of contextualized biomarkers. The framework codifies how direct, indirect, composite, and contextualized composite data can drive innovation for the application of digital biomarkers in healthcare. The de novo framework implies consideration of physiological, behavioral, and environmental factors in the context of biomarker capture and analysis. Application in disease and wellness is highlighted, and incorporation in clinical feedback loops and closed-loop systems is illustrated. The study of contextualized biomarkers has the potential to offer rich and insightful data for clinical decision making. Moreover, advancement of the field will benefit from innovation at the intersection of medicine, engineering, and science. Technological developments in this dynamic field will thus fuel its logical evolution guided by inputs from patients, physicians, healthcare providers, end-payors, actuarists, medical device manufacturers, and drug companies.

Low-power laser therapy for carpal tunnel syndrome: effective optical power

PubMed Central

Chen, Yan; Zhao, Cheng-qiang; Ye, Gang; Liu, Can-dong; Xu, Wen-dong

2016-01-01

Low-power laser therapy has been used for the non-surgical treatment of mild to moderate carpal tunnel syndrome, although its efficacy has been a long-standing controversy. The laser parameters in low-power laser therapy are closely related to the laser effect on human tissue. To evaluate the efficacy of low-power laser therapy, laser parameters should be accurately measured and controlled, which has been ignored in previous clinical trials. Here, we report the measurement of the effective optical power of low-power laser therapy for carpal tunnel syndrome. By monitoring the backside reflection and scattering laser power from human skin at the wrist, the effective laser power can be inferred. Using clinical measurements from 30 cases, we found that the effective laser power differed significantly among cases, with the measured laser reflection coefficient ranging from 1.8% to 54%. The reflection coefficient for 36.7% of these 30 cases was in the range of 10–20%, but for 16.7% of cases, it was higher than 40%. Consequently, monitoring the effective optical power during laser irradiation is necessary for the laser therapy of carpal tunnel syndrome. PMID:27630706

Breast milk feeding in infants with inherited metabolic disorders other than phenylketonuria - a 10-year single-center experience.

PubMed

Pichler, Karin; Michel, Miriam; Zlamy, Manuela; Scholl-Buergi, Sabine; Ralser, Elisabeth; Jörg-Streller, Monika; Karall, Daniela

2017-04-01

Published data on breast milk feeding in infants suffering from inherited metabolic disorders (IMDs) other than phenylketonuria (PKU) are limited and described outcome is variable. We aimed to evaluate retrospectively whether breastfeeding and/or breast milk feeding are feasible in infants with IMDs including organic acidemias, fatty acid oxidation disorders, urea cycle disorders, aminoacidopathies or disorders of galactose metabolism. Data on breastfeeding and breast milk feeding as well as monitoring and neurological outcome were collected retrospectively from our database of patients with the mentioned IMD, who were followed in our metabolic center within the last 10 years. Twenty patients were included in the study, who were either breast fed on demand or received expressed breast milk. All the infants were evaluated clinically and biochemically at 2-4-week intervals, with weight gain as the leading parameter to determine metabolic control. Good metabolic control and adequate neurological development were achieved in all patients but one, who experienced the only metabolic crisis observed within the study period. Breast milk feeding with close clinical and biochemical monitoring is feasible in most IMD and should be considered as it offers nutritional and immunological benefits.

[Monitoring methods and their results in environmental medicine - implications for medical counsellors].

PubMed

Wolter, E; Neumann, A; Straff, W

2017-06-01

Besides effect and environmental monitoring, human biomonitoring (HBM) offers an attractive method for analyzing the distribution and intensity of anthropogenic environmental pollutants in individuals or in particular groups of the population. However, no assessment values of comparable reliability are available to enable an interpretation of the results of environmental studies from the viewpoint of environmental health. This must be taken into account when reporting findings of such studies as well as in medical consultation, in order to avoid overdiagnosis and unnecessary anxiety for the participant. In medical practice, care should be taken when dealing with monitoring results outside the normal range! Environmental or biomonitoring results provide only a part of the available information alongside medical history and clinical examinations. In the case of tests performed for private interests as well as tests carried out within the framework of an epidemiological environmental survey, communication of results and findings can be problematic. In epidemiological studies, a close co-operation between the participant's consultant physician and physicians conducting the study is beneficial in order to ensure professional advisory counselling for subjects with results outside the normal range.

Recombinant to modified factor VIII and factor IX - chromogenic and one-stage assays issues.

PubMed

Kitchen, S; Kershaw, G; Tiefenbacher, S

2016-07-01

The recent development of modified recombinant factor VIII (FVIII) and factor IX (FIX) therapeutic products with extended half-lives will create challenges for the haemostasis laboratory in obtaining recovery estimates of these products in clinical samples using existing assays. The new long-acting therapeutic concentrates contain molecular modifications of Fc fusion, site-specific of polyethylene glycol or albumin fusion. The optimum methods for monitoring each new product will need to be assessed individually and laboratories should select an assay which gives similar results to the assay used to assign potency to the product in question. For some extended half-life FVIII and FIX products some one stage assays are entirely unsuitable for monitoring purposes. For most products and assay reagents studied so far, and reviewed in this manuscript, chromogenic FVIII or FIX assays can be safely used with conventional plasma standards. If one stage assays are used then they should be performed using carefully selected reagents/methods which have been shown to recover activity close to the labelled potency for the specific product being monitored. © 2016 John Wiley & Sons Ltd.

Screening and Follow-Up Monitoring for Substance Use in Primary Care: An Exploration of Rural-Urban Variations.

PubMed

Chan, Ya-Fen; Lu, Shou-En; Howe, Bill; Tieben, Hendrik; Hoeft, Theresa; Unützer, Jürgen

2016-02-01

Rates of substance use in rural areas are close to those of urban areas. While recent efforts have emphasized integrated care as a promising model for addressing workforce shortages in providing behavioral health services to those living in medically underserved regions, little is known on how substance use problems are addressed in rural primary care settings. To examine rural-urban variations in screening and monitoring primary care- based patients for substance use problems in a state-wide mental health integration program. This was an observational study using patient registry. The study included adult enrollees (n = 15,843) with a mental disorder from 133 participating community health clinics. We measured whether a standardized substance use instrument was used to screen patients at treatment entry and to monitor symptoms at follow-up visits. While on average 73.6 % of patients were screened for substance use, follow-up on substance use problems after initial screening was low (41.4 %); clinics in small/isolated rural settings appeared to be the lowest (13.6 %). Patients who were treated for a mental disorder or substance abuse in the past and who showed greater psychiatric complexities were more likely to receive a screening, whereas patients of small, isolated rural clinics and those traveling longer distances to the care facility were least likely to receive follow-up monitoring for their substance use problems. Despite the prevalent substance misuse among patients with mental disorders, opportunities to screen this high-risk population for substance use and provide a timely follow-up for those identified as at risk remained overlooked in both rural and urban areas. Rural residents continue to bear a disproportionate burden of substance use problems, with rural-urban disparities found to be most salient in providing the continuum of services for patients with substance use problems in primary care.

40 CFR 60.5416 - What are the initial and continuous cover and closed vent system inspection and monitoring...

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 7 2013-07-01 2013-07-01 false What are the initial and continuous cover and closed vent system inspection and monitoring requirements for my storage vessel and centrifugal compressor affected facility? 60.5416 Section 60.5416 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUE...

40 CFR 60.5416 - What are the initial and continuous cover and closed vent system inspection and monitoring...

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 7 2014-07-01 2014-07-01 false What are the initial and continuous cover and closed vent system inspection and monitoring requirements for my storage vessel and centrifugal compressor affected facility? 60.5416 Section 60.5416 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUE...

Unusual Surprises in Glaucoma Filtering Surgeries: Lessons Learned and Review of Literature.

PubMed

Rao, Aparna; Padhy, Debananda; Roy, Avik Kumar; Senthil, Sirisha

2018-01-01

To describe an unusual series of complications after glaucoma filtering surgeries with their clinical findings and outcome after tailored non-conventional modes of therapy. Eighteen patients who underwent re-interventions (medical or surgical) after glaucoma filtering surgeries during the period at two tertiary centers, excluding those that required conventional modes of treatment (medical control or re-trabeculectomy, simple wound closure for traumatic wound dehiscence, bleb revision or needling, laser iridotomy), were included. Relevant clinical details with intraoperative videos, intraoperative or postoperative problems, and images with course after re-intervention were retrieved from the hospital database. Clinical details which helped in clinching diagnosis and cause for problems and course after intervention with final vision and intraocular pressure were evaluated. Six of 18 eyes required surgical management for an unusual course of events after an uneventful filtering surgery. Bleb morphology and close follow-up of the conjunctiva, in addition to intraocular pressure (IOP) and anterior chamber (AC) configuration, helped diagnose possible aetiology and appropriate tailored management. All patients had good IOP and visual outcome in all except one with macular scar status after retinal detachment surgery. Assessment of the bleb morphology in the postoperative course coupled with monitoring of the conjunctival wound are essential to conventional monitoring of IOP and anterior chamber configuration to arrive at appropriate management for rare unusual events after glaucoma surgery.

Carbamazepine and its 10,11-epoxide metabolite in acute mania: clinical and pharmacokinetic correlates.

PubMed

Petit, P; Lonjon, R; Cociglio, M; Sluzewska, A; Blayac, J P; Hue, B; Alric, R; Pouget, R

1991-01-01

The study was designed to investigate the antimanic profile of carbamazepine as a first-line drug in affective or schizoaffective disorders, to correlate the clinical efficacy with the plasma level of carbamazepine and its 10,11-epoxide metabolite, and to test the potential value of monitoring the salivary level. It was administered alone for 3 weeks to 21 acute manic inpatients. During the first week, the dosage was rapidly increased to 800 mg/day in order to produce steady-state plasma levels of carbamazepine on Day 7. The individual dose was then adjusted to maintain the therapeutic range of 8-12 mg/l. Plasma and saliva levels of the drug and its metabolite, as well as clinical status were assessed weekly. Overall, there was 62% globally improved patients and 77% in affective disorders. The improvement of manic symptoms was significantly lower in schizoaffective than in affective disorders, whereas the dropout rate and the need for antipsychotic medication was higher in the former group. The antimanic response was significantly correlated with the plasma levels both of carbamazepine and its epoxide metabolite, with a time-lag consistent with a delayed drug effect. Drug and metabolite concentrations in saliva were close to their plasma free fraction and were strongly correlated with their plasma levels, suggesting the potential value of salivary drug monitoring.

Principles of Management of Central Nervous System Infections.

PubMed

Singhi, Sunit; Angurana, Suresh Kumar

2018-01-15

CNS infections in children are medical emergency and are associated with high mortality and morbidity. For diagnosis, a high index of suspicion is required. Clinical assessment should be supplemented by laboratory investigations including CSF Gram stain and cultures, blood culture, PCR on CSF, serological tests, and imaging. Commonly associated life threatening complications include coma, seizure, raised intracranial pressure (ICP), focal deficits, shock, respiratory failure, and fluid and electrolyte abnormalities. Immediate management should first address control of airway, breathing and circulation; protocolized management of raised ICP and status epilepticus; maintaining adequate intravascular volume; and close monitoring for early detection of complications. Appropriate antimicrobial agents should be administered promptly according to the suspected pathogen. Clinical evaluation, laboratory workup, specific antimicrobial therapy, supportive treatment, and management of associated complications should go hand in hand in a protocolized way for better outcome.

Comparison of warfarin therapy clinical outcomes following implementation of an automated mobile phone-based critical laboratory value text alert system.

PubMed

Lin, Shu-Wen; Kang, Wen-Yi; Lin, Dong-Tsamn; Lee, James; Wu, Fe-Lin; Chen, Chuen-Liang; Tseng, Yufeng J

2014-01-01

Computerized alert and reminder systems have been widely accepted and applied to various patient care settings, with increasing numbers of clinical laboratories communicating critical laboratory test values to professionals via either manual notification or automated alerting systems/computerized reminders. Warfarin, an oral anticoagulant, exhibits narrow therapeutic range between treatment response and adverse events. It requires close monitoring of prothrombin time (PT)/international normalized ratio (INR) to ensure patient safety. This study was aimed to evaluate clinical outcomes of patients on warfarin therapy following implementation of a Personal Handy-phone System-based (PHS) alert system capable of generating and delivering text messages to communicate critical PT/INR laboratory results to practitioners' mobile phones in a large tertiary teaching hospital. A retrospective analysis was performed comparing patient clinical outcomes and physician prescribing behavior following conversion from a manual laboratory result alert system to an automated system. Clinical outcomes and practitioner responses to both alert systems were compared. Complications to warfarin therapy, warfarin utilization, and PT/INR results were evaluated for both systems, as well as clinician time to read alert messages, time to warfarin therapy modification, and monitoring frequency. No significant differences were detected in major hemorrhage and thromboembolism, warfarin prescribing patterns, PT/INR results, warfarin therapy modification, or monitoring frequency following implementation of the PHS text alert system. In both study periods, approximately 80% of critical results led to warfarin discontinuation or dose reduction. Senior physicians' follow-up response time to critical results was significantly decreased in the PHS alert study period (46.3% responded within 1 day) compared to the manual notification study period (24.7%; P = 0.015). No difference in follow-up response time was detected for junior physicians. Implementation of an automated PHS-based text alert system did not adversely impact clinical or safety outcomes of patients on warfarin therapy. Approximately 80% immediate recognition of text alerts was achieved. The potential benefits of an automated PHS alert for senior physicians were demonstrated.

Integrated otpical monitoring of MEMS for closed-loop control

NASA Astrophysics Data System (ADS)

Dawson, Jeremy M.; Wang, Limin; McCormick, W. B.; Rittenhouse, S. A.; Famouri, Parviz F.; Hornak, Lawrence A.

2003-01-01

Robust control and failure assessment of MEMS employed in physically demanding, mission critical applications will allow for higher degrees of quality assurance in MEMS operation. Device fault detection and closed-loop control require detailed knowledge of the operational states of MEMS over the lifetime of the device, obtained by a means decoupled from the system. Preliminary through-wafer optical monitoring research efforts have shown that through-wafer optical probing is suitable for characterizing and monitoring the behavior of MEMS, and can be implemented in an integrated optical monitoring package for continuous in-situ device monitoring. This presentation will discuss research undertaken to establish integrated optical device metrology for closed-loop control of a MUMPS fabricated lateral harmonic oscillator. Successful linear closed-loop control results using a through-wafer optical microprobe position feedback signal will be presented. A theoretical optical output field intensity study of grating structures, fabricated on the shuttle of the resonator, was performed to improve the position resolution of the optical microprobe position signal. Through-wafer microprobe signals providing a positional resolution of 2 μm using grating structures will be shown, along with initial binary Fresnel diffractive optical microelement design layout, process development, and testing results. Progress in the design, fabrication, and test of integrated optical elements for multiple microprobe signal delivery and recovery will be discussed, as well as simulation of device system model parameter changes for failure assessment.

An evaluation and comparison of intraventricular, intraparenchymal, and fluid-coupled techniques for intracranial pressure monitoring in patients with severe traumatic brain injury.

PubMed

Vender, John; Waller, Jennifer; Dhandapani, Krishnan; McDonnell, Dennis

2011-08-01

Intracranial pressure measurements have become one of the mainstays of traumatic brain injury management. Various technologies exist to monitor intracranial pressure from a variety of locations. Transducers are usually placed to assess pressure in the brain parenchyma and the intra-ventricular fluid, which are the two most widely accepted compartmental monitoring sites. The individual reliability and inter-reliability of these devices with and without cerebrospinal fluid diversion is not clear. The predictive capability of monitors in both of these sites to local, regional, and global changes also needs further clarification. The technique of monitoring intraventricular pressure with a fluid-coupled transducer system is also reviewed. There has been little investigation into the relationship among pressure measurements obtained from these two sources using these three techniques. Eleven consecutive patients with severe, closed traumatic brain injury not requiring intracranial mass lesion evacuation were admitted into this prospective study. Each patient underwent placement of a parenchymal and intraventricular pressure monitor. The ventricular catheter tubing was also connected to a sensor for fluid-coupled measurement. Pressure from all three sources was measured hourly with and without ventricular drainage. Statistically significant correlation within each monitoring site was seen. No monitoring location was more predictive of global pressure changes or more responsive to pressure changes related to patient stimulation. However, the intraventricular pressure measurements were not reliable in the presence of cerebrospinal fluid drainage whereas the parenchymal measurements remained unaffected. Intraparenchymal pressure monitoring provides equivalent, statistically similar pressure measurements when compared to intraventricular monitors in all care and clinical settings. This is particularly valuable when uninterrupted cerebrospinal fluid drainage is desirable.

CEA monitoring of palliative treatment for colorectal carcinoma.

PubMed Central

Herrera, M A; Chu, T M; Holyoke, E D; Mittelman, A

1977-01-01

Palliative treatment was applied to 131 cases of unresectable or palliatively resected colorectal carcinoma being monitored with serial CEA determinations. There were 84 instances of disease progression with 67 (80%) of them showing an increase in CEA above pretreatment levels or maintaining high levels, and 17 (20%) showing a fall when compared to pretreatment values or maintaining low initial values. There was a clear-cut regression of the disease in only 9 instances. In all 9, the CEA clearly dropped or maintained low valles throughout the period of regression. No patient in regression had a rise or maintained an elevated CEA level. These changes in CEA followed closely the clinical response of our patient to the use of a particular agent, although for the Nitrosourea compounds there may be a tendency to lower the CEA regardless of the patient's tumor response to the drug. This could be due to the fact that the Nitrosoureas produce a diffuse block of cellular activity, both at the nucleous and cytoplasm; while other compounds act as alkylating agents or by inhibition of enzymes involved in the metabolism of nucleic acids (i.e., 5-FU inhibiting thymidylate synthetase). In general, longer survival was found in those patients who had initially lower levels of CEA as compared to those with high initial levels. The patients with a favorable CEA response to the treatment (falling CEA or maintained low value), even in many who did not show a clinical response had a longer survival than the group with rising or stable high levels. The main value in CEA monitoring of patients resides in its correlation with the amount of disease present and then its ability to detect progression of tumor mass which is not clinically measurable. PMID:64132

Optical Coherence Tomography Monitoring Strategies for A-VEGF—Treated Age-Related Macular Degeneration: An Evidence-Based Analysis

PubMed Central

Pron, G

2014-01-01

Background New anti-angiogenesis pharmacotherapies have dramatically altered treatment of age-related macular degeneration (AMD), the leading cause of blindness in older adults. Monthly intraocular injections however, are extremely burdensome to ophthalmologists, patients, and their families. Repeated injections also increase risks of complications or adverse events. Although the pharmacokinetics of anti–vascular endothelial growth factor (A-VEGF) drugs are fairly well known, an individuals’ AMD presentation and their pharmacodynamics or response to the drug has been shown to be extremely variable. Therefore treating everyone on the same fixed or standard regimen has potential for undertreating or overtreating patients, and drug costs are not trivial. Objectives To review monitoring strategies and to evaluate the role of optical coherence tomography (OCT) in guiding management of A-VEGF–treated neovascular AMD (n-AMD) patients. Data Sources Systematic reviews of biographic databases for studies published between 2008 and February 2013 involving A-VEGF–treated n-AMD patients monitored in longitudinal follow-up. Review Methods Studies were grouped according to varying treatments, monitoring schedules, and re-treatment protocols reported for n-AMD patients treated with A-VEGF. Several outcomes were evaluated across strategies including visual acuity (VA), retinal anatomy, re-treatment criteria and frequencies of clinical follow-up, OCT imaging investigations, and intravitreal injections. Results were summarized qualitatively, as heterogeneity in study objectives and methods precluded formal meta-analysis. Results A systematic review identified 18 randomized controlled trials (RCTs) and 20 observational studies involving A-VEGF treatment employing various monitoring and as-needed (PRN) re-treatment protocols. Several maintenance strategies were unsuccessful, resulting in lower VA gains and stabilization than monthly injections in A-VEGF–treated n-AMD. These included fixed quarterly treatment; fixed quarterly monitoring and PRN re-treatment; and monthly monitoring with either VA-guided re-treatment or quantitative-only VA/OCT- (central retinal thickness [CRT] > 100 μm) guided re-treatment. PRN re-treatment strategies with A-VEGF on the basis of monthly follow-up and rigorous reviews of OCT qualitative and quantitative measures of disease activity did decrease injection burden while maintaining visual gains. Gains in VA obtained with PRN re-treatment in usual clinical practice, however, were not as high as gains in clinical trials. Conclusions To reduce treatment burden and provide a more individualized treatment strategy for n-AMD patients, OCT/VA-guided PRN treatment strategies have become the preferred and the dominant maintenance strategy. Success of these strategies, however, is dependent on close monitoring and adherence to tightly defined re-treatment criteria. PMID:26316918

Optical Coherence Tomography Monitoring Strategies for A-VEGF-Treated Age-Related Macular Degeneration: An Evidence-Based Analysis.

PubMed

Pron, G

2014-01-01

New anti-angiogenesis pharmacotherapies have dramatically altered treatment of age-related macular degeneration (AMD), the leading cause of blindness in older adults. Monthly intraocular injections however, are extremely burdensome to ophthalmologists, patients, and their families. Repeated injections also increase risks of complications or adverse events. Although the pharmacokinetics of anti-vascular endothelial growth factor (A-VEGF) drugs are fairly well known, an individuals' AMD presentation and their pharmacodynamics or response to the drug has been shown to be extremely variable. Therefore treating everyone on the same fixed or standard regimen has potential for undertreating or overtreating patients, and drug costs are not trivial. To review monitoring strategies and to evaluate the role of optical coherence tomography (OCT) in guiding management of A-VEGF-treated neovascular AMD (n-AMD) patients. Systematic reviews of biographic databases for studies published between 2008 and February 2013 involving A-VEGF-treated n-AMD patients monitored in longitudinal follow-up. Studies were grouped according to varying treatments, monitoring schedules, and re-treatment protocols reported for n-AMD patients treated with A-VEGF. Several outcomes were evaluated across strategies including visual acuity (VA), retinal anatomy, re-treatment criteria and frequencies of clinical follow-up, OCT imaging investigations, and intravitreal injections. Results were summarized qualitatively, as heterogeneity in study objectives and methods precluded formal meta-analysis. A systematic review identified 18 randomized controlled trials (RCTs) and 20 observational studies involving A-VEGF treatment employing various monitoring and as-needed (PRN) re-treatment protocols. Several maintenance strategies were unsuccessful, resulting in lower VA gains and stabilization than monthly injections in A-VEGF-treated n-AMD. These included fixed quarterly treatment; fixed quarterly monitoring and PRN re-treatment; and monthly monitoring with either VA-guided re-treatment or quantitative-only VA/OCT- (central retinal thickness [CRT] > 100 μm) guided re-treatment. PRN re-treatment strategies with A-VEGF on the basis of monthly follow-up and rigorous reviews of OCT qualitative and quantitative measures of disease activity did decrease injection burden while maintaining visual gains. Gains in VA obtained with PRN re-treatment in usual clinical practice, however, were not as high as gains in clinical trials. To reduce treatment burden and provide a more individualized treatment strategy for n-AMD patients, OCT/VA-guided PRN treatment strategies have become the preferred and the dominant maintenance strategy. Success of these strategies, however, is dependent on close monitoring and adherence to tightly defined re-treatment criteria.

Reactive Nitrogen Monitoring Gaps: Issues, Activities and Needs

EPA Science Inventory

In this article we demonstrate the importance of ammonia and organic nitrogen to total N deposition budgets and review the current activities to close these monitoring gaps. Finally, remaining monitoring needs and issues are discussed.

Intraoperative stroke volume optimization using stroke volume, arterial pressure, and heart rate: closed-loop (learning intravenous resuscitator) versus anesthesiologists.

PubMed

Rinehart, Joseph; Chung, Elena; Canales, Cecilia; Cannesson, Maxime

2012-10-01

The authors compared the performance of a group of anesthesia providers to closed-loop (Learning Intravenous Resuscitator [LIR]) management in a simulated hemorrhage scenario using cardiac output monitoring. A prospective cohort study. In silico simulation. University hospital anesthesiologists and the LIR closed-loop fluid administration system. Using a patient simulator, a 90-minute simulated hemorrhage protocol was run, which included a 1,200-mL blood loss over 30 minutes. Twenty practicing anesthesiology providers were asked to manage this scenario by providing fluids and vasopressor medication at their discretion. The simulation program was also run 20 times with the LIR closed-loop algorithm managing fluids and an additional 20 times with no intervention. Simulated patient weight, height, heart rate, mean arterial pressure, and cardiac output (CO) were similar at baseline. The mean stroke volume, the mean arterial pressure, CO, and the final CO were higher in the closed-loop group than in the practitioners group, and the coefficient of variance was lower. The closed-loop group received slightly more fluid (2.1 v 1.9 L, p < 0.05) than the anesthesiologist group. Despite the roughly similar volumes of fluid given, the closed-loop maintained more stable hemodynamics than the practitioners primarily because the fluid was given earlier in the protocol and CO optimized before the hemorrhage began, whereas practitioners tended to resuscitate well but only after significant hemodynamic change indicated the need. Overall, these data support the potential usefulness of this closed-loop algorithm in clinical settings in which dynamic predictors are not available or applicable. Published by Elsevier Inc.

Data Sharing to Improve Close Approach Monitoring and Safety of Flight

NASA Astrophysics Data System (ADS)

Chan, Joseph; DalBello, Richard; Hope, Dean; Wauthier, Pascal; Douglas, Tim; Inghram, Travis

2009-03-01

Individual satellite operators have done a good job of developing the internal protocols and procedures to ensure the safe operation of their fleets. However, data sharing among operators for close approach monitoring is conducted in an ad-hoc manner during relocations, and there is currently no standardized agreement among operators on the content, format, and distribution protocol for data sharing. Crowding in geostationary orbit, participation by new commercial actors, government interest in satellite constellations, and highly maneuverable spacecraft all suggest that satellite operators will need to begin a dialogue on standard communication protocols and procedure to improve situation awareness. We will give an overview of the current best practices among different operators for close approach monitoring and discuss the concept of an active data center to improve data sharing, conjunction monitoring, and avoidance among satellite operators. We will also report on the progress and lessons learned from a Data Center prototype conducted by several operators over a one year period.

Laxative use and clinical correlates in hospitalized patients with obsessive-compulsive disorder: a retrospective descriptive study.

PubMed

Lai, Jianbo; Zhou, Weihua; Lu, Qiaoqiao; Huang, Tingting; Xu, Yi; Hu, Shaohua

2018-01-01

Constipation is a common clinical problem with insufficient attention. Medication-emergent constipation is a rarely studied adverse reaction in patients with obsessive-compulsive disorder (OCD). In this descriptive study, we retrospectively investigated the prevalence of laxative use and its relationship with clinical characteristics in hospitalized OCD patients. A total of 51 OCD patients were included in the final analysis. The proportion of patients using laxatives was 31.4%, and the commonly used laxatives were phenolphthalein tablet, lactulose and congrongtongbian oral liquid (a patent herbal medicine). In the laxative group, hospital stays were longer when compared to the nonlaxative group. Moreover, the dose of paroxetine was higher in patients treated with laxatives than in those without laxative use. Correlation analysis indicated that laxative use was positively associated with hospital stays, as well as the dose of paroxetine. The current study provided a preliminary picture of constipation and laxative use in hospitalized OCD patients. Close monitoring and treatment of constipation are recommended in OCD patients with pharmacotherapy.

Maple syrup urine disease: mechanisms and management.

PubMed

Blackburn, Patrick R; Gass, Jennifer M; Vairo, Filippo Pinto E; Farnham, Kristen M; Atwal, Herjot K; Macklin, Sarah; Klee, Eric W; Atwal, Paldeep S

2017-01-01

Maple syrup urine disease (MSUD) is an inborn error of metabolism caused by defects in the branched-chain α-ketoacid dehydrogenase complex, which results in elevations of the branched-chain amino acids (BCAAs) in plasma, α-ketoacids in urine, and production of the pathognomonic disease marker, alloisoleucine. The disorder varies in severity and the clinical spectrum is quite broad with five recognized clinical variants that have no known association with genotype. The classic presentation occurs in the neonatal period with developmental delay, failure to thrive, feeding difficulties, and maple syrup odor in the cerumen and urine, and can lead to irreversible neurological complications, including stereotypical movements, metabolic decompensation, and death if left untreated. Treatment consists of dietary restriction of BCAAs and close metabolic monitoring. Clinical outcomes are generally good in patients where treatment is initiated early. Newborn screening for MSUD is now commonplace in the United States and is included on the Recommended Uniform Screening Panel (RUSP). We review this disorder including its presentation, screening and clinical diagnosis, treatment, and other relevant aspects pertaining to the care of patients.

Maple syrup urine disease: mechanisms and management

PubMed Central

Farnham, Kristen M; Atwal, Herjot K; Macklin, Sarah; Klee, Eric W; Atwal, Paldeep S

2017-01-01

Maple syrup urine disease (MSUD) is an inborn error of metabolism caused by defects in the branched-chain α-ketoacid dehydrogenase complex, which results in elevations of the branched-chain amino acids (BCAAs) in plasma, α-ketoacids in urine, and production of the pathognomonic disease marker, alloisoleucine. The disorder varies in severity and the clinical spectrum is quite broad with five recognized clinical variants that have no known association with genotype. The classic presentation occurs in the neonatal period with developmental delay, failure to thrive, feeding difficulties, and maple syrup odor in the cerumen and urine, and can lead to irreversible neurological complications, including stereotypical movements, metabolic decompensation, and death if left untreated. Treatment consists of dietary restriction of BCAAs and close metabolic monitoring. Clinical outcomes are generally good in patients where treatment is initiated early. Newborn screening for MSUD is now commonplace in the United States and is included on the Recommended Uniform Screening Panel (RUSP). We review this disorder including its presentation, screening and clinical diagnosis, treatment, and other relevant aspects pertaining to the care of patients. PMID:28919799

Tinea Incognita in a Patient with Crest Syndrome: Case Report.

PubMed

Gorgievska-Sukarovska, Biljana; Skerlev, Mihael; Žele-Starčević, Lidija

2015-01-01

Tinea incognita is a dermatophytic infection that is difficult to diagnose, usually modified by inappropriate topical or systemic corticosteroid therapy. We report an extensive case of tinea incognita caused by the zoophilic dermatophyte Trichophyton mentagrophytes (var. granulosa) in a 49-year-old female patient with CREST (Calcinosis; Raynaud phenomenon; Esophageal involvement; Sclerodactyly; Teleangiectasia) syndrome. Immunocompromised patients, as well as patients with keratinization disorders, seem to be especially susceptible to dermatophytic infections with atypical clinical presentation that is sometimes bizarre and difficult to recognize. Therefore, close monitoring and mycological skin examination is recommended in order to avoid misdiagnosis and to give the patient the best chance of recovery.

Advances in neuroimaging of traumatic brain injury and posttraumatic stress disorder

PubMed Central

Van Boven, Robert W.; Harrington, Greg S.; Hackney, David B.; Ebel, Andreas; Gauger, Grant; Bremner, J. Douglas; D’Esposito, Mark; Detre, John A.; Haacke, E. Mark; Jack, Clifford R.; Jagust, William J.; Le Bihan, Denis; Mathis, Chester A.; Mueller, Susanne; Mukherjee, Pratik; Schuff, Norbert; Chen, Anthony; Weiner, Michael W.

2011-01-01

Improved diagnosis and treatment of traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) are needed for our military and veterans, their families, and society at large. Advances in brain imaging offer important biomarkers of structural, functional, and metabolic information concerning the brain. This article reviews the application of various imaging techniques to the clinical problems of TBI and PTSD. For TBI, we focus on findings and advances in neuroimaging that hold promise for better detection, characterization, and monitoring of objective brain changes in symptomatic patients with combat-related, closed-head brain injuries not readily apparent by standard computed tomography or conventional magnetic resonance imaging techniques. PMID:20104401

Carbamazepine toxicity during combination therapy with levetiracetam: a pharmacodynamic interaction.

PubMed

Sisodiya, Sanjay M; Sander, Josemir W A S; Patsalos, Philip N

2002-02-01

Levetiracetam is a novel antiepileptic drug with an unknown mechanism of action. To-date levetiracetam is not known to be associated with any clinically significant pharmacokinetic interaction. Similarly, levetiracetam has not been associated with any pharmacodynamic interactions. We present four patients with severe refractory epilepsy in whom introduction of levetiracetam led to disabling symptoms compatible with carbamazepine toxicity requiring either carbamazepine dose reduction or levetiracetam withdrawal. As carbamazepine and carbamazepine-epoxide blood levels were not altered during levetiracetam co-medication, a pharmacodynamic interaction is suggested. Therefore, during levetiracetam co-medication with carbamazepine, patients should be monitored closely for symptoms of carbamazepine toxicity.

[Development of medical supplies management system].

PubMed

Zhong, Jianping; Shen, Beijun; Zhu, Huili

2012-11-01

This paper adopts advanced information technology to manage medical supplies, in order to improve the medical supplies management level and reduce material cost. It develops a Medical Supplies Management System with B/S and C/S mixed structure, optimizing material management process, building large equipment performance evaluation model, providing interface solution with HIS, and realizing real-time information briefing of high value material's consumption. The medical materials are managed during its full life-cycle. The material consumption of the clinical departments is monitored real-timely. Through the closed-loop management with pre-event budget, mid-event control and after-event analysis, it realizes the final purpose of management yielding benefit.

Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink).

PubMed

Brachmann, Johannes; Böhm, Michael; Rybak, Karin; Klein, Gunnar; Butter, Christian; Klemm, Hanno; Schomburg, Rolf; Siebermair, Johannes; Israel, Carsten; Sinha, Anil-Martin; Drexler, Helmut

2011-07-01

The Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink (OptiLink HF) study is designed to investigate whether OptiVol fluid status monitoring with an automatically generated wireless CareAlert notification via the CareLink Network can reduce all-cause death and cardiovascular hospitalizations in an HF population, compared with standard clinical assessment. Methods Patients with newly implanted or replacement cardioverter-defibrillator devices with or without cardiac resynchronization therapy, who have chronic HF in New York Heart Association class II or III and a left ventricular ejection fraction ≤35% will be eligible to participate. Following device implantation, patients are randomized to either OptiVol fluid status monitoring through CareAlert notification or regular care (OptiLink 'on' vs. 'off'). The primary endpoint is a composite of all-cause death or cardiovascular hospitalization. It is estimated that 1000 patients will be required to demonstrate superiority of the intervention group to reduce the primary outcome by 30% with 80% power. The OptiLink HF study is designed to investigate whether early detection of congestion reduces mortality and cardiovascular hospitalization in patients with chronic HF. The study is expected to close recruitment in September 2012 and to report first results in May 2014.

In vivo swine myocardial tissue characterization and monitoring during open chest surgery by time-resolved diffuse near-infrared spectroscopy

NASA Astrophysics Data System (ADS)

Spinelli, Lorenzo; Contini, Davide; Farina, Andrea; Torricelli, Alessandro; Pifferi, Antonio; Cubeddu, Rinaldo; Ascari, Luca; Potì, Luca; Trivella, Maria Giovanna; L'Abbate, Antonio; Puzzuoli, Stefano

2011-03-01

Cardiovascular diseases are the main cause of death in industrialized countries. Worldwide, a large number of patients suffering from cardiac diseases are treated by surgery. Despite the advances achieved in the last decades with myocardial protection, surgical failure can still occur. This is due at least in part to the imperfect control of the metabolic status of the heart in the various phases of surgical intervention. At present, this is indirectly controlled by the electrocardiogram and the echographic monitoring of cardiac mechanics as direct measurements are lacking. Diffuse optical technologies have recently emerged as promising tools for the characterization of biological tissues like breast, muscles and bone, and for the monitoring of important metabolic parameters such as blood oxygenation, volume and flow. As a matter of fact, their utility has been demonstrated in a variety of applications for functional imaging of the brain, optical mammography and monitoring of muscle metabolism. However, due to technological and practical difficulties, their potential for cardiac monitoring has not yet been exploited. In this work we show the feasibility of the in-vivo determination of absorption and scattering spectra of the cardiac muscle in the 600-1100 nm range, and of monitoring myocardial tissue hemodynamics by time domain near-infrared spectroscopy at 690 nm and 830 nm. Both measurements have been performed on the exposed beating heart during open chest surgery in pigs, an experimental model closely mimicking the clinical cardio-surgical setting.

Fluid Status in Peritoneal Dialysis Patients: The European Body Composition Monitoring (EuroBCM) Study Cohort

PubMed Central

Van Biesen, Wim; Williams, John D.; Covic, Adrian C.; Fan, Stanley; Claes, Kathleen; Lichodziejewska-Niemierko, Monika; Verger, Christian; Steiger, Jurg; Schoder, Volker; Wabel, Peter; Gauly, Adelheid; Himmele, Rainer

2011-01-01

Background Euvolemia is an important adequacy parameter in peritoneal dialysis (PD) patients. However, accurate tools to evaluate volume status in clinical practice and data on volume status in PD patients as compared to healthy population, and the associated factors, have not been available so far. Methods We used a bio-impedance spectroscopy device, the Body Composition Monitor (BCM) to assess volume status in a cross-sectional cohort of prevalent PD patients in different European countries. The results were compared to an age and gender matched healthy population. Results Only 40% out of 639 patients from 28 centres in 6 countries were normovolemic. Severe fluid overload was present in 25.2%. There was a wide scatter in the relation between blood pressure and volume status. In a multivariate analysis in the subgroup of patients from countries with unrestricted availability of all PD modalities and fluid types, older age, male gender, lower serum albumin, lower BMI, diabetes, higher systolic blood pressure, and use of at least one exchange per day with the highest hypertonic glucose were associated with higher relative tissue hydration. Neither urinary output nor ultrafiltration, PD fluid type or PD modality were retained in the model (total R2 of the model = 0.57). Conclusions The EuroBCM study demonstrates some interesting issues regarding volume status in PD. As in HD patients, hypervolemia is a frequent condition in PD patients and blood pressure can be a misleading clinical tool to evaluate volume status. To monitor fluid balance, not only fluid output but also dietary input should be considered. Close monitoring of volume status, a correct dialysis prescription adapted to the needs of the patient and dietary measures seem to be warranted to avoid hypervolemia. PMID:21390320

Clinical Decision Support Improves Initial Dosing and Monitoring of Tobramycin and Amikacin

PubMed Central

Cox, Zachary L.; Nelsen, Cori L.; Waitman, Lemuel R.; McCoy, Jacob A.; Peterson, Josh F.

2010-01-01

Purpose Clinical decision support (CDS) systems could be valuable tools in reducing aminoglycoside prescribing errors. We evaluated the impact of CDS on initial dosing, interval, and pharmacokinetic outcomes of amikacin and tobramycin therapy. Methods A complex CDS advisor to provide guidance on initial dosing and monitoring, using both traditional and extended interval dosing strategies, was integrated into computerized provider order entry (CPOE) and compared to a control group which featured close pharmacy monitoring of all aminoglycoside orders. A random sample of 118 patients from an academic, tertiary care medical center prescribed amikacin and tobramycin prior to advisor implementation was compared to 98 patients admitted following advisor implementation. Primary outcome was an initial dose within 10% of a dose calculated to be adherent to published dose guidelines. Secondary outcomes were a guideline-adherent interval, trough and peak concentrations in goal range, and incidence of nephrotoxicity. Results Of 216 patients studied, 97 were prescribed amikacin and 119 were prescribed tobramycin. The primary outcome of initial dosing consistent with guideline-based care increased from 40% in the pre-advisor arm to 80% in the post-advisor arm (p<0.001), with a number needed to treat of 3 patients to prevent one incorrect dose. Correct initial interval based on renal function also increased from 63% to 87% (p<0.001). The changes in initial dosing and interval resulted in an increase of trough concentrations in the goal range from 59% pre-advisor to 89% post-advisor implementation (p=0.0004). There was no significant difference in peak concentrations in goal range or incidence of nephrotoxicity (25% vs. 17%, p=0.2). Conclusion An advisor for aminoglycoside dosing and monitoring integrated into CPOE significantly improves initial dosing, selection of interval, and trough concentrations at goal compared to unassisted physician dosing. PMID:21411805

Closed-Loop Neuropharmacology For Epilepsy: Distant Dream Or Future Reality?

PubMed

Aicua-Rapun, Irene; Andre, Pascal; Novy, Jan

2018-03-08

Epilepsy is considered the most frequent severe neurological condition but most patients treated with medication become seizure free. The management of treatment however is highly empirical, mainly relying on observation. A closed-loop therapy for epilepsy would be very valuable for more efficient treatment regimens. Here we discuss monitoring treatment (therapeutic drug monitoring) and the potential developments in this field, as well as providing a review of potential biomarkers that could be used to monitor the disease activity. Finally, we consider the pharmacogenetic input in epilepsy treatment. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Optoacoustic measurements of human placenta and umbilical blood oxygenation

NASA Astrophysics Data System (ADS)

Nanovskaya, T. N.; Petrov, I. Y.; Petrov, Y.; Patrikeeva, S. L.; Ahmed, M. S.; Hankins, G. D. V.; Prough, D. S.; Esenaliev, R. O.

2016-03-01

Adequate oxygenation is essential for normal embryogenesis and fetal growth. Perturbations in the intrauterine oxidative environment during pregnancy are associated with several pathophysiological disorders such as pregnancy loss, preeclampsia, and intrauterine growth restriction. We proposed to use optoacoustic technology for monitoring placental and fetal umbilical blood oxygenation. In this work, we studied optoacoustic monitoring of oxygenation in placenta and umbilical cord blood ex vivo using technique of placenta perfusion. We used a medical grade, nearinfrared, tunable, optoacoustic system developed and built for oxygenation monitoring in blood vessels and in tissues. First, we calibrated the system for cord blood oxygenation measurements by using a CO-Oximeter (gold standard). Then we performed validation in cord blood circulating through the catheters localized on the fetal side of an isolated placental lobule. Finally, the oxygenation measurements were performed in the perfused placental tissue. To increase or decrease blood oxygenation, we used infusion of a gas mixture of 95% O2 + 5% CO2 and 95% N2 + 5% CO2, respectively. In placental tissue, up to four cycles of changes in oxygenation were performed. The optoacoustically measured oxygenation in circulating cord blood and in placental lobule closely correlated with the actual oxygenation data measured by CO-Oximeter. We plan to further test the placental and cord blood oxygenation monitoring with optoacoustics in animal and clinical studies.

Is management of hyperglycaemia in acute phase stroke still a dilemma?

PubMed

Savopoulos, C; Kaiafa, G; Kanellos, I; Fountouki, A; Theofanidis, D; Hatzitolios, A I

2017-05-01

Close monitoring of blood glucose levels during the immediate post-acute stroke phase is of great clinical value, as there is evidence that the risk of neurological deterioration is associated with both hyper- and hypoglycaemia. The aim of this review paper is to summarise the evidence on post-stroke blood glucose management and its impact on clinical outcomes, during the early post-acute stage. Post-stroke hyperglycaemia has been associated with increased cerebral oedema, haemorrhagic transformation, lower likelihood of recanalisation and deteriorating neurological state. Thus, hyperglycaemia during an acute stroke may result in poorer clinical outcomes, infarct progression, poor functional recovery and increased mortality rates. Although hypoglycaemia may also lead to poorer outcomes via further brain injury, it can be readily reversed by glucose administration. In most patients, the goal of regular treatment is euglycaemia and for acute-stroke patients, a reasonable approach is to target control of glucose level at 100-150 mg/dL. Both hypoglycaemia and hyperglycaemia may lead to further brain injury and clinical deterioration; that is the reason these conditions should be avoided after stroke. Yet, when correcting hyperglycaemia, great care should be taken not to switch the patient into hypoglycaemia, and subsequently aggressive insulin administration treatment should be avoided. Early identification and prompt management of hyperglycaemia, especially in acute ischaemic stroke, is recommended. Although the appropriate level of blood glucose during acute stroke is still debated, a reasonable approach is to keep the patient in a mildly hyperglycaemic state, rather than risking hypoglycaemia, using continuous glucose monitoring.

The "hospital central laboratory": automation, integration and clinical usefulness.

PubMed

Zaninotto, Martina; Plebani, Mario

2010-07-01

Recent technological developments in laboratory medicine have led to a major challenge, maintaining a close connection between the search of efficiency through automation and consolidation and the assurance of effectiveness. The adoption of systems that automate most of the manual tasks characterizing routine activities has significantly improved the quality of laboratory performance; total laboratory automation being the paradigm of the idea that "human-less" robotic laboratories may allow for better operation and insuring less human errors. Furthermore, even if ongoing technological developments have considerably improved the productivity of clinical laboratories as well as reducing the turnaround time of the entire process, the value of qualified personnel remains a significant issue. Recent evidence confirms that automation allows clinical laboratories to improve analytical performances only if trained staff operate in accordance with well-defined standard operative procedures, thus assuring continuous monitoring of the analytical quality. In addition, laboratory automation may improve the appropriateness of test requests through the use of algorithms and reflex testing. This should allow the adoption of clinical and biochemical guidelines. In conclusion, in laboratory medicine, technology represents a tool for improving clinical effectiveness and patient outcomes, but it has to be managed by qualified laboratory professionals.

Measurement of jaw motion: the proposal of a simple and accurate method.

PubMed

Pinheiro, A P; Pereira, A A; Andrade, A O; Bellomo, D

2011-01-01

The analysis of jaw movements has long been used as a measure for clinical diagnosis and assessment. A number of strategies are available for monitoring the trajectory; however most of these strategies make use of expensive tools, which are often not available to many clinics in the world. In this context, this research proposes the development of a new tool capable of quantifying the movements of opening/closing, protrusion and laterotrusion of the mandible. These movements are important for the clinical evaluation of both the temporomandibular function and muscles involved in mastication. The proposed system, unlike current commercial systems, employs a low-cost video camera and a computer program, which is used for reconstructing the trajectory of a reflective marker that is fixed on the jaw. In order to illustrate the application of the devised tool a clinical trial was carried out, investigating jaw movements of 10 subjects. The results obtained in this study were compatible with those found in the literature with the advantage of using a low-cost, simple, non-invasive and flexible solution customized for the practical needs of clinics. The average error of the system was less than 1.0%.

Identification of Opportunistic Pathogenic Bacteria in Drinking Water Samples of Different Rural Health Centers and Their Clinical Impacts on Humans

PubMed Central

Pindi, Pavan Kumar; Raghuveer Yadav, P.; Shiva Shanker, A.

2013-01-01

International drinking water quality monitoring programs have been established in order to prevent or to reduce the risk of contracting water-related infections. A survey was performed on groundwater-derived drinking water from 13 different hospitals in the Mahabubnagar District. A total of 55 bacterial strains were isolated which belonged to both gram-positive and gram-negative bacteria. All the taxa were identified based on the 16S rRNA gene sequence analysis based on which they are phylogenetically close to 27 different taxa. Many of the strains are closely related to their phylogenetic neighbors and exhibit from 98.4 to 100% sequence similarity at the 16S rRNA gene sequence level. The most common group was similar to Acinetobacter junii (21.8%) and Acinetobacter calcoaceticus (10.9%) which were shared by 7 and 5 water samples, respectively. Out of 55 isolates, only 3 isolates belonged to coliform group which are Citrobacter freundii and Pantoea anthophila. More than half (52.7%, 29 strains) of the phylogenetic neighbors which belonged to 12 groups were reported to be pathogenic and isolated from clinical specimens. Out of 27 representative taxa are affiliated have eight representative genera in drinking water except for those affiliated with the genera Exiguobacterium, Delftia, Kocuria, and Lysinibacillus. PMID:23862144

Impacts of small vestibular schwannoma on community ambulation, postural, and ocular control.

PubMed

Low Choy, Nancy L; Lucey, Mary-Therese M; Lewandowski, Susan L; Panizza, Benedict J

2017-05-01

To investigate balance, community mobility, gaze instability, and dizziness handicap and assess falls risk in people who are conservatively managed with small vestibular schwannoma (VS). Cross-sectional study with controls. The study involved 18 people (mean age 58.7 ± 12.2 years) diagnosed with VS (<12 mm) and 22 age-matched controls (mean age 56.9 ± 8.0 years). Measures included standing on firm and foam surfaces with feet apart, then together with eyes open and closed, Timed Up and Go (TUG) test and dual TUG test, Dynamic Gait Index, 6-Minute Walk Test, Halmagyi Impulse Test, Dynamic Visual Acuity Test, and the Dizziness Handicap Inventory. The clinical group failed more trials standing feet together on foam with eyes closed (P < .05); had inferior mobility and walked more slowly with divided attention (P < .05); had more difficulty walking with head movement, negotiating obstacles, and using stairs (P < .01); and walked shorter distances (P < .001) than controls. Reduced gaze stability (P < .01) and higher total (P = .007) and subcategory dizziness handicap scores (P < .05) were revealed compared to age-matched controls. Although outcomes for the clinical group are inferior to the control group across all measures and the dizziness impact is higher, the results fall in the low-risk category for falls. Preliminary data (level 4 evidence) support using a suite of clinical measures to monitor people with VS during conservative management. 4 Laryngoscope, 127:1147-1152, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Efficacy and Safety of Remifentanil as an Alternative Labor Analgesic

PubMed Central

Devabhakthuni, Sandeep

2013-01-01

The objective of this review was to evaluate the clinical efficacy and safety of remifentanil in the management of labor pain. Although neuraxial analgesia is the best option during labor, alternative analgesic options are needed for patients with contraindications. Using a systematic literature search, clinical outcomes of remifentanil for labor pain have been summarized. Also, comparisons of remifentanil to other options including meperidine, epidural analgesia, fentanyl, and nitrous oxide are provided. Based on the literature review, remifentanil is associated with high overall maternal satisfaction and favorable side-effect profile. However, due to the low reporting of adverse events, large, randomized controlled trials are needed to evaluate maternal and neonatal safety adequately and determine the optimal dosing needed to provide effective analgesia. While remifentanil is a feasible alternative for patients who cannot or do not want to receive epidural analgesia, administration should be monitored closely for potential adverse effects. PMID:24665213

[The use of diuretics in kidney disease].

PubMed

Heramb, Lene; Hallan, Stein; Aasarød, Knut

2014-04-29

Diuretics are an important part of the therapy for a number of medical conditions such as heart, liver and kidney failure and hypertension. This article presents updated knowledge on the use of diuretics in kidney disease. The article is based on a literature search in PubMed, information obtained from textbooks on neurophysiology and kidney disease and on the authors' clinical experience. Kidney disease affects the pharmacokinetics and pharmacodynamics of diuretics, and this must be taken into account when selecting a drug and determining the dosage. This applies particularly to nephrotic syndrome and severe chronic renal disease (GFR < 30 ml/min/1.73 m²). Knowledge of the pharmacology of diuretics is crucial to the rational use of diuretics in renal disease. Dose titration under close clinical monitoring and an optimal dosage interval make it possible to find the lowest possible effective dose and reduce the occurrence of side effects.

Association Between Juvenile Myelomonocytic Leukemia, Juvenile Xanthogranulomas and Neurofibromatosis Type 1: Case Report and Review of the Literature.

PubMed

Paulus, Samuel; Koronowska, Sandra; Fölster-Holst, Regina

2017-03-01

The occurrence of juvenile myelomonocytic leukemia (JMML), juvenile xanthogranuloma (JXG), and neurofibromatosis type 1 (NF1) together is relatively rare. Approximately only 20 cases have been reported in the literature. It is debated whether children with NF1 and JXG are at higher risk of developing JMML than children with NF1 alone. We present the case of a boy primarily diagnosed with NF1 with coexisting JXG who developed JMML at the age of 22 months. The clinical course from initial presentation to final diagnosis is detailed and the genetic features and hematologic characteristics are discussed. We report this case to underscore the importance of close monitoring of blood count and strict clinical follow-up in children presenting with concurrent NF1 and JXG and provide a possible explanation for this association. © 2017 Wiley Periodicals, Inc.

Antithrombotic treatment in elderly patients with atrial fibrillation.

PubMed

Suárez Fernández, C; Camafort, M; Cepeda Rodrigo, J M; Díez-Manglano, J; Formiga, F; Pose Reino, A; Tiberio, G; Mostaza, J M

2015-04-01

Atrial fibrillation (AF) in the elderly is a complex condition due to the high number of frequently associated comorbidities, such as cardiovascular and kidney disease, cognitive disorders, falls and polypharmacy. Except when contraindicated, anticoagulation is necessary for preventing thromboembolic events in this population. Both vitamin K antagonists and direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) are indicated in this context. Renal function should be closely monitored for this age group when these drugs are used. In recent years, various clinical practice guidelines have been published on patients with AF. The majority of these guidelines make specific recommendations on the clinical characteristics and treatment of elderly patients. In this update, we review the specific comments on the recommendations concerning antithrombotic treatment in elderly patients with nonvalvular AF. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Delirium and refeeding syndrome in anorexia nervosa.

PubMed

Norris, Mark L; Pinhas, Leora; Nadeau, Pierre-Olivier; Katzman, Debra K

2012-04-01

To review the literature on delirium and refeeding syndrome in patients with anorexia nervosa (AN) and present case examples in an attempt to identify common clinical features and response to therapy. A comprehensive literature review was completed. In addition to the cases identified in the literature, we present two additional cases of our own. We identified a total of 10 cases (all female; mean age 19 years old, range 12-29 years); 2/3 of the cases had similar clinical features predating the delirium and during refeeding. Delirium, albeit rare, can be associated with the refeeding syndrome in low weight patients with AN. During the initial refeeding phase, close monitoring of medical, metabolic, and psychological parameters are important in establishing factors that may elevate risk. Early detection and treatment of delirium using nonpharmacologic and pharmacologic means are also important to help minimize the effects of this potentially deadly condition. Copyright © 2011 Wiley Periodicals, Inc.

Psychologist in a pocket: towards depression screening on mobile phones.

PubMed

Bitsch, Jó Ágila; Ramos, Roann; Ix, Tim; Ferrer-Cheng, Paula Glenda; Wehrle, Klaus

2015-01-01

Depression is the most prevalent clinical disorder and one of the main causes of disability. This makes early detection of depressive symptoms critical in its prevention and management. This paper presents and discusses the development of Psychologist in a Pocket (PiaP), a mental mHealth application for Android which screens and monitors for these symptoms, and-given the explicit permission of the user-alerts a trusted contact such as the mental health professional or a close friend, if it detects symptoms. All text inputted electronically-such as short message services, emails, social network posts-is analyzed based on keywords related to depression based on DSM-5 and ICD criteria as well as Beck's Cognitive Theory of Depression and the Self-Focus Model. Data evaluation and collection happen in the background, on-device, without requiring any user involvement. Currently, the application is in an early prototype phase entering initial clinical validation.

Satellite imaging and vector-borne diseases: the approach of the French National Space Agency (CNES).

PubMed

Marechal, Fabienne; Ribeiro, Nathalie; Lafaye, Murielle; Güell, Antonio

2008-11-01

Tele-epidemiology consists in studying human and animal epidemic, the spread of which is closely tied to environmental factors, using data from earth-orbiting satellites. By combining various data originated from satellites such as SPOT (vegetation indexes), Meteosat (winds and cloud masses) and other Earth observation data from Topex/Poseidon and Envisat (wave height, ocean temperature and colour) with hydrology data (number and distribution of lakes, water levels in rivers and reservoirs) and clinical data from humans and animals (clinical cases and serum use), predictive mathematical models can be constructed. A number of such approaches have been tested in the last three years. In Senegal, for example, Rift Valley fever epidemics are being monitored using a predictive model based on the rate at which water holes dry out after the rainy season, which affects the number of mosquito eggs which carry the virus.

Fuel cell system shutdown with anode pressure control

DOEpatents

Clingerman, Bruce J.; Doan, Tien M.; Keskula, Donald H.

2002-01-01

A venting methodology and pressure sensing and vent valving arrangement for monitoring anode bypass valve operating during the normal shutdown of a fuel cell apparatus of the type used in vehicle propulsion systems. During a normal shutdown routine, the pressure differential between the anode inlet and anode outlet is monitored in real time in a period corresponding to the normal closing speed of the anode bypass valve and the pressure differential at the end of the closing cycle of the anode bypass valve is compared to the pressure differential at the beginning of the closing cycle. If the difference in pressure differential at the beginning and end of the anode bypass closing cycle indicates that the anode bypass valve has not properly closed, a system controller switches from a normal shutdown mode to a rapid shutdown mode in which the anode inlet is instantaneously vented by rapid vents.

Management structures and beliefs in a professional organisation. an example from Swedish Public Dental Health Services.

PubMed

Ordell, Sven; Söderfeldt, Björn

2010-01-01

Work as a dentist is stressful and demanding. In the Public Dental Health Service (PDHS) the heads of clinics' have a great influence on the work environment. In turn the heads have to adapt to the overarching policies on management in each County, which create the environment for the clinics. The aims of this paper were to describe the management structure of the PDHS as described by their Chief Dental Officers (CDOs), and to test hypotheses that the management systems had "a logical administrative structure". A postal questionnaire was mailed to all 21 CDOs,who all responded. Context analysis and bivariate correlations were used. The PDHS employed on average 60% of all dentists in a county. The numbers of clinics for general dentistry in Sweden was 698, and for specialist care 144. The heads of clinics were dentists in 92%. Four hypotheses were tested. 1. separate political board did not lead to closer governance of the PDHS. 2. There was more emphasis on measurable than on qualitative objectives and followup. 3. There was only partial correlation between a larger county and a more formalized management. 4. There was no correlation between size of county and beliefs on advantages of scale. There was a widespread belief in advantages with larger clinics both from administrative, and rather surprisingly, from clinical aspects. Two of the four hypotheses could not be corroborated which indicates that the management structures were more formed by county specific principles. The four hypotheses on administrative behaviour were only partially corroborated. The implications for delivery of care to sparsely populated areas need to be monitored in view of the beliefs in larger clinics. The limits for decisions by management and for professional discretion must be monitored closely considering their effects on work environment and on the quality of care the professionals are able to deliver.

Monitoring of breathing motion in image-guided PBS proton therapy: comparative analysis of optical and electromagnetic technologies.

PubMed

Fattori, Giovanni; Safai, Sairos; Carmona, Pablo Fernández; Peroni, Marta; Perrin, Rosalind; Weber, Damien Charles; Lomax, Antony John

2017-03-31

Motion monitoring is essential when treating non-static tumours with pencil beam scanned protons. 4D medical imaging typically relies on the detected body surface displacement, considered as a surrogate of the patient's anatomical changes, a concept similarly applied by most motion mitigation techniques. In this study, we investigate benefits and pitfalls of optical and electromagnetic tracking, key technologies for non-invasive surface motion monitoring, in the specific environment of image-guided, gantry-based proton therapy. Polaris SPECTRA optical tracking system and the Aurora V3 electromagnetic tracking system from Northern Digital Inc. (NDI, Waterloo, CA) have been compared both technically, by measuring tracking errors and system latencies under laboratory conditions, and clinically, by assessing their practicalities and sensitivities when used with imaging devices and PBS treatment gantries. Additionally, we investigated the impact of using different surrogate signals, from different systems, on the reconstructed 4D CT images. Even though in controlled laboratory conditions both technologies allow for the localization of static fiducials with sub-millimetre jitter and low latency (31.6 ± 1 msec worst case), significant dynamic and environmental distortions limit the potential of the electromagnetic approach in a clinical setting. The measurement error in case of close proximity to a CT scanner is up to 10.5 mm and precludes its use for the monitoring of respiratory motion during 4DCT acquisitions. Similarly, the motion of the treatment gantry distorts up to 22 mm the tracking result. Despite the line of sight requirement, the optical solution offers the best potential, being the most robust against environmental factors and providing the highest spatial accuracy. The significant difference in the temporal location of the reconstructed phase points is used to speculate on the need to apply the same monitoring system for imaging and treatment to ensure the consistency of detected phases.

VHA mental health information system: applying health information technology to monitor and facilitate implementation of VHA Uniform Mental Health Services Handbook requirements.

PubMed

Trafton, Jodie A; Greenberg, Greg; Harris, Alex H S; Tavakoli, Sara; Kearney, Lisa; McCarthy, John; Blow, Fredric; Hoff, Rani; Schohn, Mary

2013-03-01

To describe the design and deployment of health information technology to support implementation of mental health services policy requirements in the Veterans Health Administration (VHA). Using administrative and self-report survey data, we developed and fielded metrics regarding implementation of the requirements delineated in the VHA Uniform Mental Health Services Handbook. Finalized metrics were incorporated into 2 external facilitation-based quality improvement programs led by the VHA Mental Health Operations. To support these programs, tailored site-specific reports were generated. Metric development required close collaboration between program evaluators, policy makers and clinical leadership, and consideration of policy language and intent. Electronic reports supporting different purposes required distinct formatting and presentation features, despite their having similar general goals and using the same metrics. Health information technology can facilitate mental health policy implementation but must be integrated into a process of consensus building and close collaboration with policy makers, evaluators, and practitioners.

Management of giant cell arteritis and polymyalgia rheumatica.

PubMed

Meskimen, S; Cook, T D; Blake, R L

2000-04-01

Giant cell arteritis and polymyalgia rheumatica are closely related disorders that affect persons more than 50 years of age and cause substantial morbidity. Patients with giant cell arteritis typically have a localized headache, nonspecific systemic symptoms, temporal artery tenderness and a high erythrocyte sedimentation rate (ESR). The diagnosis is confirmed by characteristic pathologic findings on temporal artery biopsy. Patients with polymyalgia rheumatica usually have similar nonspecific systemic symptoms, proximal muscle pain and stiffness, and an elevated ESR. The diagnosis is based on the clinical findings. Both disorders are treated with corticosteroids: high dosages for giant cell arteritis (prednisone in a dosage of 40 to 60 mg per day) and lower dosages for polymyalgia rheumatica (prednisone in a dosage of 10 to 20 mg per day). Symptom relief in response to treatment is rapid and reinforces the diagnosis. After normalization of the ESR, the corticosteroid is tapered, with the patient monitored closely for symptom recurrence. Most patients require corticosteroid therapy for two to three years and experience one or more treatment complications.

IDLN-MSP: Idiolocal normalization of real-time methylation-specific PCR for genetic imbalanced DNA specimens.

PubMed

Santourlidis, Simeon; Ghanjati, Foued; Beermann, Agnes; Hermanns, Thomas; Poyet, Cédric

2016-02-01

Sensitive, accurate, and reliable measurements of tumor cell-specific DNA methylation changes are of fundamental importance in cancer diagnosis, prognosis, and monitoring. Real-time methylation-specific PCR (MSP) using intercalating dyes is an established method of choice for this purpose. Here we present a simple but crucial adaptation of this widely applied method that overcomes a major obstacle: genetic abnormalities in the DNA samples, such as aneuploidy or copy number variations, that could result in inaccurate results due to improper normalization if the copy numbers of the target and reference sequences are not the same. In our idiolocal normalization (IDLN) method, the locus for the normalizing, methylation-independent reference amplification is chosen close to the locus of the methylation-dependent target amplification. This ensures that the copy numbers of both the target and reference sequences will be identical in most cases if they are close enough to each other, resulting in accurate normalization and reliable comparative measurements of DNA methylation in clinical samples when using real-time MSP.

AP@home: a novel European approach to bring the artificial pancreas home.

PubMed

Heinemann, Lutz; Benesch, Carsten; DeVries, J Hans

2011-11-01

The development of an artificial pancreas (AP) made huge strides from 2006 to 2008 and a large number of activities are going on in this area of research. Until now, most AP systems under development were tested only under highly controlled conditions. The aim of our project, funded by the European Union, is to develop an AP system to such a level that it can be studied under daily life conditions at the home of patients with diabetes (hence AP@home). Based on a subcutaneous-subcutaneous closed-loop strategy (i.e., glucose sensing and insulin infusion in the subcutaneous tissue), two different approaches will be taken to achieve this aim: a two-port AP system and a single-port AP system. The two-port AP system will use off-the-shelf-components for the glucose sensor and insulin pump in combination with closed-loop algorithms generated in Europe. As to the single-port AP system, two different innovative single-port systems will be developed; in this case, continuous glucose monitoring and insulin infusion will take place via a single catheter. The first clinical trials with the two-port AP system under controlled clinical conditions have started and good progress has been made in the development of the single-port AP systems. We believe that our consortium of 12 European partners, which builds on existing achievements and close cooperation between academic centers and industry, can contribute substantially to the development of an AP system that can be used by patients in daily life. © 2011 Diabetes Technology Society.

A Survey of Staphylococcus sp and its Methicillin Resistance aboard the International Space Station

NASA Technical Reports Server (NTRS)

Bassinger, V. J.; Fontenot, S. L.; Castro, V. A.; Ott, C.; Healy, M.; Pierson, D. L.

2004-01-01

Background: Within the past few years, methicillin-resistant Staphylococcus aureus has emerged in environments with susceptible hosts in close proximity, such as hospitals and nursing homes. As the International Space Station (ISS) represents a semi-closed environment with a high level of crewmember interaction, an evaluation of isolates of clinical and environmental Staphylococcus aureus and coagulase negative Staphylococcus was performed to determine if this trend was also present in astronauts occupying ISS or on surfaces of the space station itself. Methods: Identification of isolates was completed using VITEK (GPI cards, BioMerieux), 16S ribosomal DNA analysis (MicroSeq 500, ABI), and Rep-PCR DNA fingerprinting (Divemilab, Bacterial Barcodes). Susceptibility tests were performed using VITEK (GPS-105 cards, BioMerieux) and resistance characteristics were evaluated by testing for the presence of the mecA gene (PBP2' MRSA test kit, Oxoid). Results: Rep-PCR analysis indicated the transfer of S. aureus between crewmembers and between crewmembers and ISS surfaces. While a variety of S. aureus were identified from both the crewmembers and environment, evaluations of the microbial population indicated minimal methicillin resistance. Results of this study indicated that within the semi-closed ISS environment, transfer of bacteria between crewmembers and their environment has been occurring, although there was no indication of a high concentration of methicillin resistant Staphylococcus species. Conclusions: While this study suggests that the spread of methicillin resistant S. aureus is not currently a concern aboard ISS, the increasing incidence of Earth-based antibiotic resistance indicates a need for continued clinical and environmental monitoring.

New technologies in the management of risk and violence in forensic settings.

PubMed

Tully, John; Larkin, Fintan; Fahy, Thomas

2015-06-01

Novel technological interventions are increasingly used in mental health settings. In this article, we describe 3 novel technological strategies in use for management of risk and violence in 2 forensic psychiatry settings in the United Kingdom: electronic monitoring by GPS-based tracking devices of patients on leave from a medium secure service in London, and closed circuit television (CCTV) monitoring and motion sensor technology at Broadmoor high secure hospital. A common theme is the use of these technologies to improve the completeness and accuracy of data used by clinicians to make clinical decisions. Another common thread is that each of these strategies supports and improves current clinical approaches rather than drastically changing them. The technologies offer a broad range of benefits. These include less restrictive options for patients, improved accountability of both staff and patients, less invasive testing, improved automated record-keeping, and better assurance reporting. Services utilizing technologies need also be aware of limitations. Technologies may be seen as unduly restrictive by patients and advocates, and technical issues may reduce effectiveness. It is vital that the types of technological innovations described in this article should be subject to thorough evaluation that addresses cost effectiveness, qualitative analysis of patients' attitudes, safety, and ethical considerations.

[Efficacy of lisdexamphetamine to improve the behavioural and cognitive symptoms of attention deficit hyperactivity disorder: treatment monitored by means of the AULA Nesplora virtual reality test].

PubMed

Diaz-Orueta, U; Fernandez-Fernandez, M A; Morillo-Rojas, M D; Climent, G

2016-07-01

Lisdexanfetamine (LDX) is the drug for attention deficit hyperactivity disorder (ADHD) undergoing the largest research volume in the latest years. However, no studies certify its usefulness for the improvement of cognitive functioning in ADHD. To evaluate the efficacy of LDX in the behavioral and cognitive improvement of a group of patients with ADHD. Such efficacy was measured by means of the administration of AULA Nesplora virtual reality test before the prescription of pharmacological treatment and right after the treatment with LDX. The sample comprised 85 patients between 6 and 16 years, with clinical diagnosis of ADHD, who attended treatment in a neuropediatrics consultation. All patients started pharmacological treatment with the proper dose of LDX after the clinical interview and the first administration of AULA test. After an average treatment of 7.5 months, AULA was administered again and the treatment progress based on cognitive and motor symptomatology was assessed. Results showed highly significant improvements in selective and sustained attention, quality of attention focus and hyperactivity; moderate improvements in impulsivity; and an incidence close to zero in processing speed. LDX constitutes an adequate treatment for the substantial improvement of attention and hyperactivity; such improvement can be monitored accurately by means of AULA virtual reality test.

A computer-controlled, closed-loop infusion system for infusing muscle relaxants: its use during motor-evoked potential monitoring.

PubMed

Stinson, L W; Murray, M J; Jones, K A; Assef, S J; Burke, M J; Behrens, T L; Lennon, R L

1994-02-01

A microcomputer-controlled closed-loop infusion system (MCCLIS) has been developed that provides stable intraoperative levels of partial neuromuscular blockade. Complete neuromuscular blockade interferes with intraoperative motor-evoked potential (MEP) monitoring used for patients undergoing surgical procedures that place them at risk for spinal cord ischemia. Nine patients were studied during which the MCCLIS maintained stable levels of partial neuromuscular blockade and allowed transcranial magnetic motor-evoked potential (TcM-MEP) monitoring during thoracoabdominal aortic aneurysmectomy. The use of TcM-MEP for monitoring intraoperative spinal cord function was balanced against surgical considerations for muscle relaxation with 80% to 90% neuromuscular blockade fulfilling each requirement. Intraoperative adjustment of partial neuromuscular blockade to facilitate TcM-MEP monitoring was also possible with the MCCLIS. The MCCLIS should allow for further investigation into the sensitivity, specificity, and predictability of TcM-MEP monitoring for any patient at risk for intraoperative spinal cord ischemia including those undergoing thoracoabdominal aortic aneurysmectomy.

Evaluation of a multiple-species approach to monitoring species at the ecoregional scale

Treesearch

Patricia N. Manley; William J. Zielinski; Matthew D. Schlesinger; Sylvia R. Mori

2004-01-01

Monitoring is required of land managers and conservation practitioners to assess the success of management actions. "Shortcuts" are sought to reduce monitoring costs, most often consisting of the selection of a small number of species that are closely monitored to represent the status of many associated species and environmental correlates. Assumptions...

Endogenous CO monitoring in exhalation with tunable diode lasers: applications to clinical and biomedical diagnostics

NASA Astrophysics Data System (ADS)

Stepanov, Eugene V.; Zyrianov, Pavel V.; Miliaev, Valerii A.; Shulagin, Yurii A.; D'yachenko, Alexander I.

1999-07-01

Middle IR tunable diode lasers were applied to studies of pulmonary excretion of endogenous carbon monoxide (CO). Variations of the CO content level in exhaled air of healthy nonsmokers were investigated for different environmental conditions with the applied laser technique. Correlation of the obtained data with atmospheric CO contamination and elevated oxygen content were studied as well as diurnal variations of the endogenous CO in exhalation was observed. Criteria for correct conditions of the endogenous CO detection in breath could be derive don this basis. Developed laser approach and methods were applied for the analysis of the excreted CO level in different diseases like bronchial asthma, cystic fibrosis, idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, anemia and hepatitis. Laser based close-to-real-time monitoring of the endogenous CO elimination with breath in the course of different dynamic tests was demonstrated to be informative in studies of blood oxygen transport and pH variations in tissues for different challenges tests in human physiology.

Multiday Fully Closed Loop Insulin Delivery in Monitored Outpatient Conditions

ClinicalTrials.gov

2014-04-29

To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days.; To Assess Effectiveness in Maintaining Patients' Glucose Levels in the Target Range of 70 to 180 mg/dl, Measured by Blood Glucose Sensor.; To Evaluate the User Experience With a Closed Loop System

Oxygen monitor for semi-closed rebreathers: design and use for estimating metabolic oxygen consumption

NASA Astrophysics Data System (ADS)

Clarke, John R.; Southerland, David

1999-07-01

Semi-closed circuit underwater breathing apparatus (UBA) provide a constant flow of mixed gas containing oxygen and nitrogen or helium to a diver. However, as a diver's work rate and metabolic oxygen consumption varies, the oxygen percentages within the UBA can change dramatically. Hence, even a resting diver can become hypoxic and become at risk for oxygen induced seizures. Conversely, a hard working diver can become hypoxic and lose consciousness. Unfortunately, current semi-closed UBA do not contain oxygen monitors. We describe a simple oxygen monitoring system designed and prototyped at the Navy Experimental Diving Unit. The main monitor components include a PIC microcontroller, analog-to-digital converter, bicolor LED, and oxygen sensor. The LED, affixed to the diver's mask is steady green if the oxygen partial pressure is within pre- defined acceptable limits. A more advanced monitor with a depth senor and additional computational circuitry could be used to estimate metabolic oxygen consumption. The computational algorithm uses the oxygen partial pressure and the diver's depth to compute O2 using the steady state solution of the differential equation describing oxygen concentrations within the UBA. Consequently, dive transients induce errors in the O2 estimation. To evalute these errors, we used a computer simulation of semi-closed circuit UBA dives to generate transient rich data as input to the estimation algorithm. A step change in simulated O2 elicits a monoexponential change in the estimated O2 with a time constant of 5 to 10 minutes. Methods for predicting error and providing a probable error indication to the diver are presented.

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.

A Closed-Cycle Optical Cryostat and Improved Optical Elements for Studies of Dissipation at the Molecular Scale

DTIC Science & Technology

2016-02-05

diode laser, Raman spectroscopy REPORT DOCUMENTATION PAGE 11. SPONSOR/MONITOR’S REPORT NUMBER(S) 10. SPONSOR/MONITOR’S ACRONYM(S) ARO 8...this project supported the acquisition of a closed-cycle optical cryostat from Montana Instruments, as well as a new 785 nm diode laser and ultrahigh...planned experiments on inelastic electron tunneling spectroscopy that require TɝK for optimal resolution. Additionally, the spatial position of

Clinical requirements for closed-loop control systems.

PubMed

Clarke, William L; Renard, Eric

2012-03-01

Closed-loop (CL) therapy systems should be safe, efficacious, and easily manageable for type 1 diabetes mellitus patient use. For the first two clinical requirements, noninferiority and superiority criteria must be determined based on current conventional and intensive therapy outcomes. Current frequencies of hypoglycemia and diabetic ketoacidosis are reviewed and safety expectations for CL therapy systems are proposed. Glycosylated hemoglobin levels lower than current American Diabetes Association recommendations for different age groups are proposed as superiority criteria. Measures of glycemic variability are described and the recording of blood glucose levels as percentages within, above, and below a target range are suggested as reasonable alternatives to sophisticated statistical analyses. It is also suggested that Diabetes Quality of Life and Fear of Hypoglycemia surveys should be used to track psychobehavioral outcomes. Manageability requirements for safe and effective clinical management of CL systems are worth being underscored. The weakest part of the infusion system remains the catheter, which is exposed to variable and under-delivery incidents. Detection methods are needed to warn both the system and the patient about altered insulin delivery, including internal pressure and flow alarms. Glucose monitor sensor accuracy is another requirement; it includes the definition of conditions that lead to capillary glucose measurement, eventually followed by sensor recalibration or replacement. The crucial clinical requirement will be a thorough definition of the situations when the patient needs to move from CL to manual management of insulin delivery, or inversely can switch back to CL after a requested interruption. Instructions about these actions will constitute a major part of the education process of the patients before using CL systems and contribute to the manageability of these systems. © 2012 Diabetes Technology Society.

[Progress in the development of insulin pumps and their advanced automatic functions].

PubMed

Prázný, Martin

2015-04-01

Patients with type 1 diabetes are exposed to permanent burden consisting of careful glucose self-monitoring and precise insulin dosage based on measured glucose values, carbohydrates content in the food and both planned and non-planned physical activity. Erroneous insulin dosing causes frequent both hypoglycemia and hyperglycemia. Hypoglycemia is, however, the most clinically significant complication limiting the optimal diabetes control. Automatic features for insulin dosage integrated in insulin pumps are thus very important. Low glucose suspend (LGS) and Predictive Low Glucose Management (PLGM) use glucose sensor values to prevent hypoglycemia, shorten the time spent in hypoglycemic range and present further step forward to fully closed-loop system of insulin treatment.

[Discuss about Alarm Requirements of Standards for Tests of Patient Monitor].

PubMed

Feng, Ting

This paper introduces the alarm requirements of standards of patient monitor and expounds their significance for tests and guidance for patient monitor, then discusses whether technical alarm should not be closed and it latching alarm and non-latching alarm can not exist together.

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...

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.

New Criteria for Assessing the Accuracy of Blood Glucose Monitors Meeting, October 28, 2011

PubMed Central

Walsh, John; Roberts, Ruth; Vigersky, Robert A.; Schwartz, Frank

2012-01-01

Glucose meters (GMs) are routinely used for self-monitoring of blood glucose by patients and for point-of-care glucose monitoring by health care providers in outpatient and inpatient settings. Although widely assumed to be accurate, numerous reports of inaccuracies with resulting morbidity and mortality have been noted. Insulin dosing errors based on inaccurate GMs are most critical. On October 28, 2011, the Diabetes Technology Society invited 45 diabetes technology clinicians who were attending the 2011 Diabetes Technology Meeting to participate in a closed-door meeting entitled New Criteria for Assessing the Accuracy of Blood Glucose Monitors. This report reflects the opinions of most of the attendees of that meeting. The Food and Drug Administration (FDA), the public, and several medical societies are currently in dialogue to establish a new standard for GM accuracy. This update to the FDA standard is driven by improved meter accuracy, technological advances (pumps, bolus calculators, continuous glucose monitors, and insulin pens), reports of hospital and outpatient deaths, consumer complaints about inaccuracy, and research studies showing that several approved GMs failed to meet FDA or International Organization for Standardization standards in post-approval testing. These circumstances mandate a set of new GM standards that appropriately match the GMs’ analytical accuracy to the clinical accuracy required for their intended use, as well as ensuring their ongoing accuracy following approval. The attendees of the New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting proposed a graduated standard and other methods to improve GM performance, which are discussed in this meeting report. PMID:22538160

New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting, October 28, 2011.

PubMed

Walsh, John; Roberts, Ruth; Vigersky, Robert A; Schwartz, Frank

2012-03-01

Glucose meters (GMs) are routinely used for self-monitoring of blood glucose by patients and for point-of-care glucose monitoring by health care providers in outpatient and inpatient settings. Although widely assumed to be accurate, numerous reports of inaccuracies with resulting morbidity and mortality have been noted. Insulin dosing errors based on inaccurate GMs are most critical. On October 28, 2011, the Diabetes Technology Society invited 45 diabetes technology clinicians who were attending the 2011 Diabetes Technology Meeting to participate in a closed-door meeting entitled New Criteria for Assessing the Accuracy of Blood Glucose Monitors. This report reflects the opinions of most of the attendees of that meeting. The Food and Drug Administration (FDA), the public, and several medical societies are currently in dialogue to establish a new standard for GM accuracy. This update to the FDA standard is driven by improved meter accuracy, technological advances (pumps, bolus calculators, continuous glucose monitors, and insulin pens), reports of hospital and outpatient deaths, consumer complaints about inaccuracy, and research studies showing that several approved GMs failed to meet FDA or International Organization for Standardization standards in postapproval testing. These circumstances mandate a set of new GM standards that appropriately match the GMs' analytical accuracy to the clinical accuracy required for their intended use, as well as ensuring their ongoing accuracy following approval. The attendees of the New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting proposed a graduated standard and other methods to improve GM performance, which are discussed in this meeting report. © 2012 Diabetes Technology Society.

78 FR 11660 - Clinical Center; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Clinical Center; Notice of... Clinical Center. The meeting will be closed to the public as indicated below in accordance with the... evaluation of individual intramural programs and projects conducted by the CLINICAL CENTER, including...

Optimized methods for epilepsy therapy development using an etiologically realistic model of focal epilepsy in the rat

PubMed Central

Eastman, Clifford L.; Fender, Jason S.; Temkin, Nancy R.; D’Ambrosio, Raimondo

2015-01-01

Conventionally developed antiseizure drugs fail to control epileptic seizures in about 30% of patients, and no treatment prevents epilepsy. New etiologically realistic, syndrome-specific epilepsy models are expected to identify better treatments by capturing currently unknown ictogenic and epileptogenic mechanisms that operate in the corresponding patient populations. Additionally, the use of electrocorticography permits better monitoring of epileptogenesis and the full spectrum of acquired seizures, including focal nonconvulsive seizures that are typically difficult to treat in humans. Thus, the combined use of etiologically realistic models and electrocorticography may improve our understanding of the genesis and progression of epilepsy, and facilitate discovery and translation of novel treatments. However, this approach is labor intensive and must be optimized. To this end, we used an etiologically realistic rat model of posttraumatic epilepsy, in which the initiating fluid percussion injury closely replicates contusive closed-head injury in humans, and has been adapted to maximize epileptogenesis and focal non-convulsive seizures. We obtained week-long 5-electrode electrocorticography 1 month post-injury, and used a Monte-Carlo-based non-parametric bootstrap strategy to test the impact of electrode montage design, duration-based seizure definitions, group size and duration of recordings on the assessment of posttraumatic epilepsy, and on statistical power to detect antiseizure and antiepileptogenic treatment effects. We found that use of seizure definition based on clinical criteria rather than event duration, and of recording montages closely sampling the activity of epileptic foci, maximize the power to detect treatment effects. Detection of treatment effects was marginally improved by prolonged recording, and 24 h recording epochs were sufficient to provide 80% power to detect clinically interesting seizure control or prevention of seizures with small groups of animals. We conclude that appropriate electrode montage and clinically relevant seizure definition permit convenient deployment of fluid percussion injury and electrocorticography for epilepsy therapy development. PMID:25523813

Application of fiber Bragg grating sensors in monitoring fatigue failure of NiTi rotary endodontic instruments

NASA Astrophysics Data System (ADS)

Liu, C. Y.; Shin, C. S.

2012-04-01

NiTi endodontic rotary instruments subjected to alternating tension and compression stress in root canals may fracture without prior warning. Once broken, extracting the fractured part from the canal is a difficult job and is annoying to both the patient and the dentist. Warning of an imminent fracture during clinical use will be a great help to avoid medical and legal complications. A monitoring system employing Fiber Bragg Grating (FBG) sensors has been attempted. The reason of using FBG is its small size which is very promising in integrating with the handpiece of the endodontic equipment. When cracking developed in an rotary instrument, we expect the natural vibration frequency of the instrument changes. If we can pick up the stress wave transmitted through the structural components of the rotary instruments, we may be able to detect the occurrence of a crack. In the current work, we found that we can successfully locate the operation period in the time domain by picking up and analyzing the sound wave using FBG. Furthermore, by employing Fast Fourier Transform (FFT) on the signal, we can reveal the energy variation and the frequency shifting phenomenon in specific section of frequency domain. For some characteristic frequencies, it was found that the energy and frequency varied in a well-defined pattern during the period of crack growth. It is hoped that with these information, the fatigue failure of rotary instruments can be closely monitored to avoid/alleviate the occurrence of unexpected fracture during clinical use.

Application of fiber Bragg grating sensors in monitoring fatigue failure of NiTi rotary endodontic instruments

NASA Astrophysics Data System (ADS)

Liu, C. Y.; Shin, C. S.

2011-11-01

NiTi endodontic rotary instruments subjected to alternating tension and compression stress in root canals may fracture without prior warning. Once broken, extracting the fractured part from the canal is a difficult job and is annoying to both the patient and the dentist. Warning of an imminent fracture during clinical use will be a great help to avoid medical and legal complications. A monitoring system employing Fiber Bragg Grating (FBG) sensors has been attempted. The reason of using FBG is its small size which is very promising in integrating with the handpiece of the endodontic equipment. When cracking developed in an rotary instrument, we expect the natural vibration frequency of the instrument changes. If we can pick up the stress wave transmitted through the structural components of the rotary instruments, we may be able to detect the occurrence of a crack. In the current work, we found that we can successfully locate the operation period in the time domain by picking up and analyzing the sound wave using FBG. Furthermore, by employing Fast Fourier Transform (FFT) on the signal, we can reveal the energy variation and the frequency shifting phenomenon in specific section of frequency domain. For some characteristic frequencies, it was found that the energy and frequency varied in a well-defined pattern during the period of crack growth. It is hoped that with these information, the fatigue failure of rotary instruments can be closely monitored to avoid/alleviate the occurrence of unexpected fracture during clinical use.

Actigraphy in Human African Trypanosomiasis as a Tool for Objective Clinical Evaluation and Monitoring: A Pilot Study

PubMed Central

Njamnshi, Alfred K.; Seke Etet, Paul F.; Perrig, Stephen; Acho, Alphonse; Funsah, Julius Y.; Mumba, Dieudonné; Muyembe, Jean-Jacques; Kristensson, Krister; Bentivoglio, Marina

2012-01-01

Background Human African trypanosomiasis (HAT) or sleeping sickness leads to a complex neuropsychiatric syndrome with characteristic sleep alterations. Current division into a first, hemolymphatic stage and second, meningoencephalitic stage is primarily based on the detection of white blood cells and/or trypanosomes in the cerebrospinal fluid. The validity of this criterion is, however, debated, and novel laboratory biomarkers are under study. Objective clinical HAT evaluation and monitoring is therefore needed. Polysomnography has effectively documented sleep-wake disturbances during HAT, but could be difficult to apply as routine technology in field work. The non-invasive, cost-effective technique of actigraphy has been widely validated as a tool for the ambulatory evaluation of sleep disturbances. In this pilot study, actigraphy was applied to the clinical assessment of HAT patients. Methods/Principal Findings Actigraphy was recorded in patients infected by Trypanosoma brucei gambiense, and age- and sex-matched control subjects. Simultaneous nocturnal polysomnography was also performed in the patients. Nine patients, including one child, were analyzed at admission and two of them also during specific treatment. Parameters, analyzed with user-friendly software, included sleep time evaluated from rest-activity signals, rest-activity rhythm waveform and characteristics. The findings showed sleep-wake alterations of various degrees of severity, which in some patients did not parallel white blood cell counts in the cerebrospinal fluid. Actigraphic recording also showed improvement of the analyzed parameters after treatment initiation. Nocturnal polysomnography showed alterations of sleep time closely corresponding to those derived from actigraphy. Conclusions/Significance The data indicate that actigraphy can be an interesting tool for HAT evaluation, providing valuable clinical information through simple technology, well suited also for long-term follow-up. Actigraphy could therefore objectively contribute to the clinical assessment of HAT patients. This method could be incorporated into a clinical scoring system adapted to HAT to be used in the evaluation of novel treatments and laboratory biomarkers. PMID:22348168

Improving Translation from Preclinical Studies to Clinical Trials in Acute Kidney Injury.

PubMed

Fiorentino, Marco; Kellum, John A

2018-05-23

Several cellular and molecular targets and mechanisms have been investigated in preclinical studies of acute kidney injury (AKI), but translation in successful clinical studies has failed to date. This article reviews many issues that have limited this and the potential future perspectives in AKI prevention and treatment. Preclinical models of AKI should closely mimic the complexity of human AKI, considering the importance of several comorbidities in determining the clinical course and outcomes in the human disease. Moreover, studies should test novel interventions in models where AKI is already established, instead of focusing only at primary prevention. AKI definitions and endpoints in animal studies should be similar to those applied in clinical studies; in particular, AKI biomarkers should be implemented to guide patient selection for clinical trials and monitor intervention efficacy. In this scenario, cell-cycle arrest biomarkers have been widely investigated as AKI predictors in both preclinical and clinical studies and they serve as useful tools for future interventional studies. A better understanding of human AKI through a large collection of biological samples and kidney biopsies and omics applications, and an iterative relationship between preclinical and clinical studies are critical steps to improve future preclinical models and clinical trials. Finally, given the great variability in clinical manifestation of AKI, a strong collaboration between research centers and industry is recommended. Key messages: Several methodological issues have hampered the translation of basic research findings in clinical studies, and overcoming these obstacles is necessary to achieve success. © 2018 S. Karger AG, Basel.

Development of Clinically Relevant Implantable Pressure Sensors: Perspectives and Challenges

PubMed Central

Clausen, Ingelin; Glott, Thomas

2014-01-01

This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians. Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported. PMID:25248071

Infectious Disease Issues in Xenotransplantation

PubMed Central

Boneva, Roumiana S.; Folks, Thomas M.; Chapman, Louisa E.

2001-01-01

Xenotransplantation, the transplantation of living organs, tissues, or cells from one species to another, is viewed as a potential solution to the existing shortage of human organs for transplantation. While whole-organ xenotransplantation is still in the preclinical stage, cellular xenotransplantation and extracorporeal perfusion applications are showing promise in early clinical trials. Advances in immunosuppressive therapy, gene engineering, and cloning of animals bring a broader array of xenotransplantation protocols closer to clinical trials. Despite several potential advantages over allotransplantation, xenotransplantation encompasses a number of problems. Immunologic rejection remains the primary hindrance. The potential to introduce infections across species barriers, another major concern, is the main focus of this review. Nonhuman primates are unlikely to be a main source for xenotransplantation products despite their phylogenetic proximity to humans. Genetically engineered pigs, bred under special conditions, are currently envisaged as the major source. Thus far, there has been no evidence for human infections caused by pig xenotransplantation products. However, the existence of xenotropic endogenous retroviruses and the clinical evidence of long-lasting porcine cell microchimerism indicate the potential for xenogeneic infections. Thus, further trials should continue under regulatory oversight, with close clinical and laboratory monitoring for potential xenogeneic infections. PMID:11148000

Development of clinically relevant implantable pressure sensors: perspectives and challenges.

PubMed

Clausen, Ingelin; Glott, Thomas

2014-09-22

This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians.  Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported.

40 CFR 65.156 - General monitoring requirements for control and recovery devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONSOLIDATED FEDERAL AIR RULE Closed Vent Systems, Control Devices, and Routing to a Fuel Gas System or a Process § 65.156 General monitoring requirements for... systems. (1) All monitoring equipment shall be installed, calibrated, maintained, and operated according...

Commercialization Issues For Catheter-Based Electrochemical Sensors

NASA Astrophysics Data System (ADS)

Nikolchev, Julian; Gaisford, Scott

1989-08-01

The need for continuous monitoring of key clinical parameters in hospitals is well recognized. Figure 1 shows typical time constants for blood gases, ions and enzymes in response to acute ventilatory changes and interventions. Although it can be seen that relatively low rates of data collection are necessary for many medical measurements, it is also clear that intermittent measurement of P02, PCO2 and pH are not sufficient to provide safe and effective management of the patient. Very frequent or continuous monitoring is often essential. This figure also shows why the emphasis of a large number of research efforts in this country and in Europe and Japan have as their goal the development of continuous blood gas sensors, i.e., sensors that continuously monitor blood pH, partial pressure of oxygen and partial pressure of carbon dioxide. These are three (3) of the most frequent parameters measured in hospitals and the ones having the shortest time constant. Considering that in the United States alone close to 25 million blood gas samples per year are taken from patients, the potential market for continuous monitoring sensors is enormous. The emergence of microelectronics and microfabrication technologies over the past 30 years are now pointing to a possible resolution of the well recognized need for real time monitoring of critically ill patients through catheter-based sensors. Although physicians will always prefer non-invasive monitoring techniques, there are a number of parameters that presently can only be monitored by invasive method. The emerging ability to miniaturize chemical sensors using silicon microfabrication or fiber-optic techniques offer an excellent opportunity to solve this need. In fact, the development of in vivo biomedical sensors with satisfactory performance characteristics has long been considered the ultimate application of these emerging technologies.

Comparison of the docetaxel concentration in human plasma measured with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and a nanoparticle immunoassay and clinical applications of that assay.

PubMed

Geng, Chunmei; Li, Pingli; Chen, Xuwang; Yuan, Guiyan; Guo, Nan; Liu, Huanjun; Zhang, Rui; Guo, Ruichen

2017-05-23

To determine the feasibility of using a nanoparticle immunoassay for clinical therapeutic drug monitoring (TDM) of docetaxel concentrations, a sensitive and simple method of liquid chromatography-tandem mass spectrometry (LC-MS/MS) was established to measure the docetaxel concentration in human plasma and the results of LC-MS/MS and the immunoassay were compared. Docetaxel and paclitaxel (the internal standard, or IS) in human plasma were extracted through protein precipitation, separated on a Diamonsil C18 column (150 mm × 4.6 mm, 5 μm), ionized with positive ions, and detected with LC-MS/MS in multi-reaction monitoring (MRM) mode. Plasma samples from 248 cancer patients were assayed with LC-MS/MS and a nanoparticle immunoassay. Data from the samples were analyzed with the statistical software SPSS and the software MedCalc. Results indicated that the calibration curve of the validated method of LC-MS/MS was linear over the range of 10-2,000 ng/mL, with an lowest limit of quantitation (LLOQ) of 10 ng/mL, and the intra- and inter- day precision and accuracy were both < ± 15%. Comparison of the two methods indicated that results of the LC-MS/MS were closely related to those of the nanoparticle immunoassay, with a correlation coefficient (R) of 0.965 and acceptable 95% confidence intervals (CI) of ‒ 231.7-331.1 ng/mL. Overall, the established method of LC-MC/MS and the nanoparticle immunoassay were both suitable for measurement of the docetaxel concentration in human plasma, and the immunoassay was far more cost-effective and better at clinical TDM of docetaxel in clinical practice.

Generic immunosuppression in solid organ transplantation: a Canadian perspective.

PubMed

Harrison, Jennifer J; Schiff, Jeffrey R; Coursol, Christian J; Daley, Christopher J A; Dipchand, Anne I; Heywood, Norine M; Keough-Ryan, Tammy M; Keown, Paul A; Levy, Gary A; Lien, Dale C; Wichart, Jenny R; Cantarovich, Marcelo

2012-04-15

The introduction of generic immunosuppressant medications may present an opportunity for cost savings in solid organ transplantation if equivalent clinical outcomes to the branded counterparts can be achieved. An interprofessional working group of the Canadian Society of Transplantation was established to develop recommendations on the use of generic immunosuppression in solid organ transplant recipients (SOTR) based on a review of the available data. Under current Health Canada licensing requirements, a demonstration of bioequivalence with the branded formulation in healthy volunteers allows for bridging of clinical data. Cyclosporine, tacrolimus, and sirolimus are designated as "critical dose drugs" and are held to stricter criteria. However, whether this provides sufficient guarantee of therapeutic equivalence in SOTR remains controversial, and failure to maintain an appropriate balance of immunosuppression may have serious consequences, including rejection, graft loss, and death. Published evidence supporting therapeutic equivalence of generic formulations in SOTR is lacking. Moreover, in the setting of multiple generic formulations the potential for uncontrolled product switching is a major concern, since generic preparations are not required to demonstrate bioequivalence with each other. Although close monitoring is recommended with any change in formulation, drug product switches are likely to occur without prescriber knowledge and may pose a significant patient safety risk. The advent of generic immunosuppression will require new practices including more frequent therapeutic drug and clinical monitoring, and increased patient education. The additional workload placed on transplant centers without additional funding will create challenges and could ultimately jeopardize patient outcomes. Until more robust clinical data are available and adequate regulatory safeguards are instituted, caution in the use of generic immunosuppressive drugs in solid organ transplantation is warranted.

21 CFR 886.5820 - Closed-circuit television reading system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... reading system. (a) Identification. A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Closed-circuit television reading system. 886.5820...

Clinical Practice Guideline for Vitamin D

NASA Technical Reports Server (NTRS)

Tarver, William J.

2013-01-01

Vitamin D and its metabolites have clinical significance because they play a critical function in calcium homeostasis and bone metabolism. Although not all of the pathologic mechanisms have been adequately described, vitamin D insufficiency and deficiency, as measured by low levels of 25-OH vitamin D, are associated with a variety of clinical conditions including osteoporosis, falls and fractures in the elderly, decreased immune function, bone pain, and possibly colon cancer and cardiovascular health.2 Apart from inadequate dietary intake, patients may present with low levels of vitamin D if they receive inadequate sunlight. The astronaut population is potentially vulnerable to low levels of vitamin D for several reasons. Firstly, they may train for long periods in Star City, Russia, which by virtue of its northern latitude receives less sunlight in winter months. Secondly, astronauts are deprived of sunlight while aboard the International Space Station (ISS). In addition, ISS crew members are exposed to microgravity for prolonged durations and are likely to develop low bone mineral density despite the use of countermeasures. Therefore, closely monitoring and maintaining adequate vitamin D levels is important for the astronaut corps.

Accuracy verification and identification of matrix effects. The College of American Pathologists' Protocol.

PubMed

Eckfeldt, J H; Copeland, K R

1993-04-01

Proficiency testing using stabilized control materials has been used for decades as a means of monitoring and improving performance in the clinical laboratory. Often, the commonly used proficiency testing materials exhibit "matrix effects" that cause them to behave differently from fresh human specimens in certain clinical analytic systems. Because proficiency testing is the primary method in which regulatory agencies have chosen to evaluate clinical laboratory performance, the College of American Pathologists (CAP) has proposed guidelines for investigating the influence of matrix effects on their Survey results. The purpose of this investigation was to determine the feasibility, usefulness, and potential problems associated with this CAP Matrix Effect Analytical Protocol, in which fresh patient specimens and CAP proficiency specimens are analyzed simultaneously by a field method and a definitive, reference, or other comparative method. The optimal outcome would be that both the fresh human and CAP Survey specimens agree closely with the comparative method result. However, this was not always the case. Using several different analytic configurations, we were able to demonstrate matrix and calibration biases for several of the analytes investigated.

[Clinical and laboratory characteristics of patients with pathologic chronic gastroesophageal reflux].

PubMed

Csendes, A; Burdiles, P; Maluenda, F; Cortés, C; Korn, O; Rojas, J; Tepper, P; Huertas, C; Sagastume, H; Puente, G; Quezada, F; Csendes, P

1998-07-01

Sixty percent of adults has typical symptoms of gastroesophageal reflux in Chile. To report the clinical and laboratory features of patients with gastroesophageal reflux. Five hundred thirty-four patients (255 male) with gastroesophageal reflux were included in a prospective protocol that included clinical analysis, manometry and endoscopy in all patients, barium swallow in 427, scintigraphy in 195, acid reflux test in 359, 24 h pH in 175, and differential potential of gastroesophageal mucosa in 73 patients. There was no correlation between the severity of symptoms and the endoscopical severity. Patients with Barret esophagus were 12 years older, were male in a greater proportion and had a higher proportion of manometrically incompetent sphincters than patients with esophageal reflux but without esophagitis or with erosive esophagitis. Severity of acid reflux, measured with 24 h pH monitoring was proportional to the endoscopical damage of the mucosa. There was a close relationship between the mucosal change limit determined with differential potentials and with endoscopy. No short esophagi were found. Patients with symptoms of gastroesophageal reflux must be assessed using several objective measures to determine the severity of their pathological alterations.

40 CFR 63.828 - Monitoring requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) National Emission Standards for the Printing and Publishing Industry § 63.828 Monitoring requirements. (a... device to the atmosphere. (ii) Secure any bypass line valve in the closed position with a car-seal or a...

40 CFR 63.828 - Monitoring requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) National Emission Standards for the Printing and Publishing Industry § 63.828 Monitoring requirements. (a... device to the atmosphere. (ii) Secure any bypass line valve in the closed position with a car-seal or a...

40 CFR 63.828 - Monitoring requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) National Emission Standards for the Printing and Publishing Industry § 63.828 Monitoring requirements. (a... device to the atmosphere. (ii) Secure any bypass line valve in the closed position with a car-seal or a...

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

Use of continuous glucose monitoring in patients with type 1 diabetes.

PubMed

Ellis, Samuel L; Naik, Ramachandra G; Gemperline, Kate; Garg, Satish K

2008-08-01

The prevalence of type 1 diabetes continues to increase worldwide at a rate higher than previously projected, while the number of patients achieving American Diabetes Association (ADA) glycated hemoglobin (A1c) goals remains suboptimal. There are numerous barriers to patients achieving A1c targets including increased frequency of severe hypoglycemia associated with lowering plasma glucose as measured by lower A1c values. Continuous glucose monitoring (CGM) was first approved for retrospective analysis and now has advanced to the next step in diabetes management with the approval of real-time glucose sensing. Real-time CGM, in short term studies, has been shown to decrease A1c values, improve glucose variability (GV), and minimize the time and number of hypoglycemic events in patients with type 1 diabetes. These products are approved for adjunctive use to self-monitoring of blood glucose (SMBG), but future long-term studies are needed to document their safety, efficacy, ability to replace SMBG as a tool of monitoring, and ultimately utility into closed-loop insulin delivery systems. New algorithms will need to be developed that account for rapid changes in the glucose values, so that accuracy of the sensor data can be maintained. In addition, for better clinical care and usage, algorithms also need to be developed for both patients and the providers to guide them for their ongoing diabetes care.

Immune monitoring of clinical trials with biotherapies.

PubMed

Whiteside, Theresa L

2008-01-01

Immune monitoring of biotherapy clinical trials has undergone a considerable change in recent years. Technical advances together with new insights into molecular immunology have ushered a new genre of assays into immune monitoring. Single-cell assays, multiplex profiling, and signaling molecule detection have replaced formerly used bulk assays, such as proliferation or cytotoxicity. The emphasis on immune cell functions and quantitation of antigen-specific T cells has been playing a major role in attempts to establish correlations between therapy-induced alterations in immune responses and clinical endpoints. However, this has been an elusive goal to achieve, and there is a special need for improving the quality of serial monitoring to ensure that it adequately and reliably measures changes induced by administered biotherapy. In this respect, monitoring performed in specialized reference laboratories operating as good laboratory practice (GLP) facilities and strengthening of interactions between the clinical investigator, the clinical immunologist, and the biostatistician are crucial for successful use of immune monitoring in clinical studies.

[What role for paraclinical investigations within clinical trials conducted in psychiatric patients?

PubMed

Kaladjian, A; Adida, M; Simon, N; Belzeaux, R; Blin, O; Fakra, E; Azorin, J-M

2016-12-01

As in the usual care of patients, paraclinical investigations have today only a very modest role in clinical trials in psychiatry, mainly to complete the pre-therapeutical assessments prior to inclusion of subjects or to monitor treatment tolerance. Yet, the accumulation of data in neurosciences suggests the next emergence of biomarkers, whose interest is that they are closely associated to the biological disturbances underlying psychiatric illnesses, and that they are accessible by means of technological tools such as imaging devices. These tools allow to explore the effects on brain of psychotropic medications, such as antidepressants, antipsychotics, or mood stabilizers, in relation to their therapeutic action. The obtained results allow to consider the use of such biomarkers in clinical trials in addition to more conventional approaches. In particular, they could be used as targets to measure brain response to treatment in association with clinical response, to predict a therapeutic response from the neurofunctional characteristics of patients, or to establish the safety profile of drugs on the nervous system. The use of such biomarkers in clinical trials would help to better define the explored populations and their characteristics, as well as the variables to assess, and to better measure the impact of the treatments and their potential harmful effects on the nervous system. © L’Encéphale, Paris, 2016.

Fecal Calprotectin Levels Are Closely Correlated with the Absence of Relevant Mucosal Lesions in Postoperative Crohn's Disease.

PubMed

Garcia-Planella, Esther; Mañosa, Míriam; Cabré, Eduard; Marín, Laura; Gordillo, Jordi; Zabana, Yamile; Boix, Jaume; Sáinz, Sergio; Domènech, Eugeni

2016-12-01

Fecal calprotectin (FC) is the best noninvasive biomarker of disease activity in inflammatory bowel disease. Its correlation with endoscopic mucosal lesions could save inconvenient, expensive, and repeated endoscopic examinations in particular clinical settings. To assess the correlation between FC and the existence and severity of endoscopic postoperative recurrence (POR), a group of clinically stable outpatients with Crohn's disease for whom an ileocolonoscopy was routinely planned to assess POR were invited to collect a stool sample before starting bowel cleansing to measure FC. POR was graded by means of Rutgeerts endoscopic score. One hundred nineteen ileocolonoscopies were included, 42% with endoscopic POR. FC was significantly lower in the absence of endoscopic POR and in the absence of any endoscopic lesion. The area under the receiver operating characteristic curve was 0.76 (95% confidence interval, 0.68-0.85) for the diagnosis of the absence of lesions and 0.75 (95% confidence interval, 0.66-0.84) for endoscopic POR. Better sensitivity and negative predictive value were observed when combining FC and serum C-reactive protein (CRP), leading to a sensitivity of 82%, a specificity of 53%, and negative and positive predictive values of 81% and 54%, respectively, for the prediction of endoscopic POR with a combination of FC 100 μg/g and CRP 5 mg/L cutoff values. FC correlates closely with endoscopic POR in clinically stable postoperative patients with Crohn's disease and, when used in combination with CRP, might save endoscopic examinations and allow for a high-grade suspicion of endoscopic POR in the long-term monitoring of these patients.

Postural control is altered in patients with ankylosing spondylitis.

PubMed

Vergara, Martin E; O'Shea, Finbar D; Inman, Robert D; Gage, William H

2012-05-01

Ankylosing spondylitis is a chronic inflammatory disorder that can lead to increased axial and peripheral joint stiffness, impairing joint mobility. Impaired axial mobility due to vertebral ankylosis may result in changes in standing postural control. Little research has addressed changes in standing postural control in the ankylosing spondylitis population, nor how these issues might affect clinical understanding and treatment. Sixteen ankylosing spondylitis patients, and 17 healthy controls participated. Each individual completed two 120-second quiet standing trials with eyes open and eyes closed, while standing upon two force platforms. Net center of pressure displacement and mean power frequency in the frontal and sagittal planes were calculated. A Spearman's rank correlation analysis was performed between net center of pressure measures and several clinical measures of disease activity. Frontal plane net center of pressure displacement and frequency content, and sagittal plane net center of pressure displacement were significantly greater within the ankylosing spondylitis patient group. Ankylosing spondylitis patients demonstrated a significant increase in frontal plane net center of pressure displacement in the eyes-closed condition. Net center of pressure displacement and frequency were significantly correlated to the Bath Ankylosing Spondylitis Functional Index, and individual components of the Bath Ankylosing Spondylitis Metrology Index. Quiet standing postural control was altered particularly so in the frontal plane in patients with ankylosing spondylitis, which may be associated with increased fall risk. Posturographic measures of postural control may serve as valuable clinical tools for the monitoring of disease progression and disease status in ankylosing spondylitis. Copyright © 2011 Elsevier Ltd. All rights reserved.

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

Closed-Loop Control of Humidification for Artifact Reduction in Capacitive ECG Measurements.

PubMed

Leicht, Lennart; Eilebrecht, Benjamin; Weyer, Soren; Leonhardt, Steffen; Teichmann, Daniel

2017-04-01

Recording biosignals without the need for direct skin contact offers new opportunities for ubiquitous health monitoring. Electrodes with capacitive coupling have been shown to be suitable for the monitoring of electrical potentials on the body surface, in particular ECG. However, due to triboelectric charge generation and motion artifacts, signal and thus diagnostic quality is inferior to galvanic coupling. Active closed-loop humidification of capacitive electrodes is proposed in this work as a new concept to improve signal quality. A capacitive ECG recording system integrated into a common car seat is presented. It can regulate the micro climate at the interface of electrode and patient by actively dispensing water vapour and monitoring humidity in a closed-loop approach. As a regenerative water reservoir, silica gel is used. The system was evaluated with respect to subjective and objective ECG signal quality. Active humidification was found to have a significant positive effect in case of previously poor quality. Also, it had no diminishing effect in case of already good signal quality.

40 CFR 63.7188 - What are my monitoring installation, operation, and maintenance requirements?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Semiconductor Manufacturing Compliance Requirements § 63.7188 What are my monitoring installation, operation... emissions of your semiconductor process vent through a closed vent system to a control device, you must...

40 CFR 63.7188 - What are my monitoring installation, operation, and maintenance requirements?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Semiconductor Manufacturing Compliance Requirements § 63.7188 What are my monitoring installation, operation... emissions of your semiconductor process vent through a closed vent system to a control device, you must...

Close-up view of Sunflower Seeds

NASA Image and Video Library

2013-11-04

ISS037-E-026274 (4 Nov. 2013) --- A two-day old sunflower sprout is being closely monitored in its temporary home inside a plastic bag by the Expedition 37 crew members onboard the Earth-orbiting International Space Station.

Diagnosis, monitoring and management of immune-related adverse drug reactions of anti-PD-1 antibody therapy.

PubMed

Eigentler, Thomas K; Hassel, Jessica C; Berking, Carola; Aberle, Jens; Bachmann, Oliver; Grünwald, Viktor; Kähler, Katharina C; Loquai, Carmen; Reinmuth, Niels; Steins, Martin; Zimmer, Lisa; Sendl, Anna; Gutzmer, Ralf

2016-04-01

PD-1 checkpoint inhibitors are associated with a specific spectrum of immune-related adverse events. This spectrum is different from toxicities known for kinase inhibitors or cytotoxic drugs. Since PD-1 directed therapies show effectivity in an increasing number of malignant diseases, their clinical usage will increase rapidly. Therefore clinicians from different specialities such as medical oncology, internal medicine, family doctors and emergency unit staff should be aware of the adverse effects of PD-1 checkpoint inhibitors to avoid delays in diagnosis and treatment. Based on pooled data from pivotal trials as reported by the European Medicines Agency, the present paper reviews incidences and kinetics of onset and resolution of immune-mediated "adverse events of specific interest" (AEOSI) of both approved PD-1 inhibitors nivolumab and pembrolizumab. In general, the severity of AEOSI is mild to moderate (grade 1-2); the frequency of immune-mediated but also idiopathic grade 3-4 adverse drug reactions is ⩽2% for any event term. Recommendations for the diagnosis, monitoring and management of the relevant dermatological, gastrointestinal, pulmonary, endocrine, renal and hepatic toxicities are convened by an expert panel that consolidated and clarified treatment recommendations after the onset of AEOSI. Although the time of onset is not predictable - the medians range from 1 to 6months - the huge majority of events is reversible, with no impact of the time of onset. By the systemic use of glucocorticoids, notably methylprednisolone or equivalents, most AEOSI are well manageable. Non-steroidal immunosuppressants may be used in certain cases of refractory/recalcitrant, long-lasting immune toxicities. With regard to the outstanding clinical activity of the anti-PD-1 antibodies, therapy restart is the principal therapeutic option after recovery of grade 2 AEOSI, or diminution of higher grade skin or endocrine events to mild severity. Early diagnosis and close clinical monitoring are essential for successful management of immune-related adverse events. Copyright © 2016 Elsevier Ltd. All rights reserved.

Closed loop kinesthetic feedback for postural control rehabilitation.

PubMed

Vérité, Fabien; Bachta, Wael; Morel, Guillaume

2014-01-01

Postural control rehabilitation may benefit from the use of smart devices providing biofeedback. This approach consists of increasing the patients perception of their postural state. Namely, postural state is monitored and fed back in real time to the patients through one or more sensory channels. This allows implementing rehabilitation exercises where the patients control their posture with the help of additional sensory inputs. In this paper, a closed loop control of the Center-Of-Pressure (CoP) based on kinesthetic feedback is proposed as a new form of biofeedback. The motion of a one Degree of Freedom (DoF) translational device, lightly touched by the patient's forefinger, is servoed to the patient's CoP position extracted from the measurements of a force plate on which he/she stands. As a result, the patient's CoP can be controllably displaced. A first set of experiments is used to prove the feasibility of this closed-loop control under ideal conditions favoring the perception of the kinesthetic feedback, while the subject is totally unaware of the context. A second set of experiments is then proposed to evaluate the robustness of this approach under experimental conditions that are more realistic with regards to the clinical context of a rehabilitation program involving biofeedback-based exercises.

A sensitive and accurate quantification method for the detection of hepatitis B virus covalently closed circular DNA by the application of a droplet digital polymerase chain reaction amplification system.

PubMed

Mu, Di; Yan, Liang; Tang, Hui; Liao, Yong

2015-10-01

To develop a sensitive and accurate assay system for the quantification of covalently closed circular HBV DNA (cccDNA) for future clinical monitoring of cccDNA fluctuation during antiviral therapy in the liver of infected patients. A droplet digital PCR (ddPCR)-based assay system detected template DNA input at the single copy level (or ~10(-5) pg of plasmid HBV DNA) by using serially diluted plasmid HBV DNA samples. Compared with the conventional quantitative PCR assay in the detection of cccDNA, which required at least 50 ng of template DNA input, a parallel experiment applying a ddPCR system demonstrates that the lowest detection limit of cccDNA from HepG2.215 cellular DNA samples is around 1 ng, which is equivalent to 0.54 ± 0.94 copies of cccDNA. In addition, we demonstrated that the addition of cccDNA-safe exonuclease and utilization of cccDNA-specific primers in the ddPCR assay system significantly improved the detection accuracy of HBV cccDNA from HepG2.215 cellular DNA samples. The ddPCR-based cccDNA detection system is a sensitive and accurate assay for the quantification of cccDNA in HBV-transfected HepG2.215 cellular DNA samples and may represent an important method for future application in monitoring cccDNA fluctuation during antiviral therapy.

Application of Unmanned Aerial System-based Photogrammetry to Monitor Landforms Evolution of Mudstone Badlands

NASA Astrophysics Data System (ADS)

Chen, Yichin

2017-04-01

Mudstone badlands are the area characteristized by its rapid erosion and steep, fractured, and barren landforms. Monitoring the topography changes in badland help improve our knowledge of the hillslope and river processing on landforms and develop susceptibility model for surface erosion hazards. Recently, advances in unmanned aerial system (UAS) and close-range photogrammetry technology have opened up the possibility of effectively measuring topography changes with high spatiotemporal resolutions. In this study, we used the UAS and close-range photogrammetry technology to monitor the topography changes in a rapidly eroded badland, south-western Taiwan. A small mudstone hillslope with area of 0.2 ha approximately and with slope gradient of 37 degrees was selected as the study site. A widely used and commercial quadcopter equipped non-metric camera was used to take images with ground sampling distance (GSD) 5 mm approximately. The Pix4DMapper, a commercial close-range photogrammetry software, was used to perform stereo matching, extract point clouds, generate digital surface models (DSMs) and orthoimage. To control model accuracy, a set of ground control points was surveyed by using eGPS. The monitoring was carried out after every significant rainfall event that may induced observable erosion in the badland site. The results show that DSMs have the GSDs of 4.0 5.4 mm and vertical accuracy of 61 116 mm. The accuracy largely depends on the quality of ground control points. The spatial averaged erosion rate during six months of monitoring was 328 mm, which is higher in the gully sides than in the ridges. The erosion rate is positively correlated with the slope gradient and drainage contributing area that implies the important role of surface gully erosion in mudstone badland erosion. This study shows that UAS and close-range photogrammetry technology can be used to monitor the topography change in badland areas effectively and can provide high spatiotemporal resolutions of DSMs for developing distributed surface erosion models.

Self-Monitoring Success and Failure: Evidence for a Mediating Mechanism.

ERIC Educational Resources Information Center

Susser, Howard S.

Two theories, the closed loop model (divides self-regulation into self-monitoring, self-evaluation, and self-reinforcement) and the non-mediational model (defines self-regulation as behavior that is controlled by its long-term and observable consequences), have been proposed to explain why behavior changes when self-monitoring occurs. Both…

National Stream Quality Accounting Network and National Monitoring Network Basin Boundary Geospatial Dataset, 2008–13

USGS Publications Warehouse

Baker, Nancy T.

2011-01-01

This report and the accompanying geospatial data were created to assist in analysis and interpretation of water-quality data provided by the U.S. Geological Survey's National Stream Quality Accounting Network (NASQAN) and by the U.S. Coastal Waters and Tributaries National Monitoring Network (NMN), which is a cooperative monitoring program of Federal, regional, and State agencies. The report describes the methods used to develop the geospatial data, which was primarily derived from the National Watershed Boundary Dataset. The geospatial data contains polygon shapefiles of basin boundaries for 33 NASQAN and 5 NMN streamflow and water-quality monitoring stations. In addition, 30 polygon shapefiles of the closed and noncontributing basins contained within the NASQAN or NMN boundaries are included. Also included is a point shapefile of the NASQAN and NMN monitoring stations and associated basin and station attributes. Geospatial data for basin delineations, associated closed and noncontributing basins, and monitoring station locations are available at http://water.usgs.gov/GIS/metadata/usgswrd/XML/ds641_nasqan_wbd12.xml.

Decoupled tracking and thermal monitoring of non-stationary targets.

PubMed

Tan, Kok Kiong; Zhang, Yi; Huang, Sunan; Wong, Yoke San; Lee, Tong Heng

2009-10-01

Fault diagnosis and predictive maintenance address pertinent economic issues relating to production systems as an efficient technique can continuously monitor key health parameters and trigger alerts when critical changes in these variables are detected, before they lead to system failures and production shutdowns. In this paper, we present a decoupled tracking and thermal monitoring system which can be used on non-stationary targets of closed systems such as machine tools. There are three main contributions from the paper. First, a vision component is developed to track moving targets under a monitor. Image processing techniques are used to resolve the target location to be tracked. Thus, the system is decoupled and applicable to closed systems without the need for a physical integration. Second, an infrared temperature sensor with a built-in laser for locating the measurement spot is deployed for non-contact temperature measurement of the moving target. Third, a predictive motion control system holds the thermal sensor and follows the moving target efficiently to enable continuous temperature measurement and monitoring.

Patient perspective on remote monitoring of cardiovascular implantable electronic devices: rationale and design of the REMOTE-CIED study.

PubMed

Versteeg, H; Pedersen, S S; Mastenbroek, M H; Redekop, W K; Schwab, J O; Mabo, P; Meine, M

2014-10-01

Remote patient monitoring is a safe and effective alternative for the in-clinic follow-up of patients with cardiovascular implantable electronic devices (CIEDs). However, evidence on the patient perspective on remote monitoring is scarce and inconsistent. The primary objective of the REMOTE-CIED study is to evaluate the influence of remote patient monitoring versus in-clinic follow-up on patient-reported outcomes. Secondary objectives are to: 1) identify subgroups of patients who may not be satisfied with remote monitoring; and 2) investigate the cost-effectiveness of remote monitoring. The REMOTE-CIED study is an international randomised controlled study that will include 900 consecutive heart failure patients implanted with an implantable cardioverter defibrillator (ICD) compatible with the Boston Scientific LATITUDE® Remote Patient Management system at participating centres in five European countries. Patients will be randomised to remote monitoring or in-clinic follow-up. The In-Clinic group will visit the outpatient clinic every 3-6 months, according to standard practice. The Remote Monitoring group only visits the outpatient clinic at 12 and 24 months post-implantation, other check-ups are performed remotely. Patients are asked to complete questionnaires at five time points during the 2-year follow-up. The REMOTE-CIED study will provide insight into the patient perspective on remote monitoring in ICD patients, which could help to support patient-centred care in the future.

Collection of liquid from below-ground location

DOEpatents

Phillips, Steven J.; Alexander, Robert G.

1995-01-01

A method of retrieving liquid from a below-ground collection area by permitting gravity flow of the liquid from the collection area to a first closed container; monitoring the level of the liquid in the closed container; and after the liquid reaches a given level in the first closed container, transferring the liquid to a second closed container disposed at a location above the first closed container, via a conduit, by introducing into the first closed container a gas which is substantially chemically inert with respect to the liquid, the gas being at a pressure sufficient to propel the liquid from the first closed container to the second closed container.

Request to monitor 2035-01 AE Aqr for multiwavelength campaign AND Reminder to monitor HT Cas, Z Cha, and OY Car

NASA Astrophysics Data System (ADS)

Waagen, Elizabeth O.

2005-08-01

AAVSO Alert Notice 326 contains two topics. First: Dr. Christopher Mauche (Lawrence Livermore National Laboratory) has requested our assistance in monitoring the novalike intermediate polar AE Aqr in support of multiwavelength (gamma-ray, X-ray, UV, optical, and radio) observations scheduled for August-September 2005. AAVSO observations, particularly CCD ones, are requested to correlate with these multiwavelength observations; visual observations are also encouraged. Second: as announced in Alert Notice 317, Drs. Christopher Mauche, Peter Wheatley, and Koji Mukai have obtained time on XMM-Newton to observe HT Cas, Z Cha, or OY Car in outburst, and they have requested our assistance in monitoring these stars closely so we can inform them promptly when any of them go into outburst. Very prompt notification is essential because of the time required to trigger the satellite and the shortness of the outbursts of the target stars. Please monitor HT Cas, OY Car, and Z Cha closely from now through at least a month after the last observing window closes, and notify Headquarters immediately if any of the target stars goes into outburst. Both visual and CCD observations are encouraged. Finder charts with sequence may be created using the AAVSO Variable Star Plotter (https://www.aavso.org/vsp). Observations should be submitted to the AAVSO International Database. See full Alert Notice for more details.

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.

Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative.

PubMed

Calis, Karim A; Archdeacon, Patrick; Bain, Raymond; DeMets, David; Donohue, Miriam; Elzarrad, M Khair; Forrest, Annemarie; McEachern, John; Pencina, Michael J; Perlmutter, Jane; Lewis, Roger J

2017-08-01

Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative-a public-private partnership to improve clinical trials-launched a multi-stakeholder project. Methods The data monitoring committee project team included 16 individuals charged with (1) clarifying the purpose of data monitoring committees, (2) identifying best practices for independent data monitoring committee conduct, (3) describing effective communication practices, and (4) developing strategies for training data monitoring committee members. Evidence gathering included a survey, a series of focus group discussions, and a 2-day expert meeting aimed at achieving consensus opinions that form the foundation of our data monitoring committee recommendations. Results We define the role of the data monitoring committee as an advisor to the research sponsor on whether to continue, modify, or terminate a trial based on periodic assessment of trial data. Data monitoring committees should remain independent from the sponsor and be composed of members with no relevant conflicts of interest. Representation on a data monitoring committee generally should include at least one clinician with expertise in the therapeutic area being studied, a biostatistician, and a designated chairperson who has experience with clinical trials and data monitoring. Data monitoring committee meetings are held periodically to evaluate the unmasked data from ongoing trials, but the content and conduct of meetings may vary depending on specific goals or topics for deliberation. To guide data monitoring committee conduct and communication plans, a charter consistent with the protocol's research design and statistical analysis plan should be developed and agreed upon by the sponsor and the data monitoring committee prior to patient enrollment. We recommend concise and flexible charters that explain roles, responsibilities, operational issues, and how data monitoring committee recommendations are generated and communicated. The demand for data monitoring committee members appears to exceed the current pool of qualified individuals. To prepare a new generation of trained data monitoring committee members, we encourage a combination of didactic educational programs, practical experience, and skill development through apprenticeships and mentoring by experienced data monitoring committee members. Conclusion Our recommendations address data monitoring committee use, conduct, communication practices, and member preparation and training. Furthermore recommendations form the foundation for ongoing efforts to improve clinical trial oversight and enhance the safety and integrity of clinical research. These recommendations serve as a call to action for implementation of best practices that benefit study participants, study sponsors, and society.

Clonal hematopoiesis in acquired aplastic anemia.

PubMed

Ogawa, Seishi

2016-07-21

Clonal hematopoiesis (CH) in aplastic anemia (AA) has been closely linked to the evolution of late clonal disorders, including paroxysmal nocturnal hemoglobinuria and myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML), which are common complications after successful immunosuppressive therapy (IST). With the advent of high-throughput sequencing of recent years, the molecular aspect of CH in AA has been clarified by comprehensive detection of somatic mutations that drive clonal evolution. Genetic abnormalities are found in ∼50% of patients with AA and, except for PIGA mutations and copy-neutral loss-of-heterozygosity, or uniparental disomy (UPD) in 6p (6pUPD), are most frequently represented by mutations involving genes commonly mutated in myeloid malignancies, including DNMT3A, ASXL1, and BCOR/BCORL1 Mutations exhibit distinct chronological profiles and clinical impacts. BCOR/BCORL1 and PIGA mutations tend to disappear or show stable clone size and predict a better response to IST and a significantly better clinical outcome compared with mutations in DNMT3A, ASXL1, and other genes, which are likely to increase their clone size, are associated with a faster progression to MDS/AML, and predict an unfavorable survival. High frequency of 6pUPD and overrepresentation of PIGA and BCOR/BCORL1 mutations are unique to AA, suggesting the role of autoimmunity in clonal selection. By contrast, DNMT3A and ASXL1 mutations, also commonly seen in CH in the general population, indicate a close link to CH in the aged bone marrow, in terms of the mechanism for selection. Detection and close monitoring of somatic mutations/evolution may help with prediction and diagnosis of clonal evolution of MDS/AML and better management of patients with AA. © 2016 by The American Society of Hematology.

Clonal hematopoiesis in acquired aplastic anemia

PubMed Central

2016-01-01

Clonal hematopoiesis (CH) in aplastic anemia (AA) has been closely linked to the evolution of late clonal disorders, including paroxysmal nocturnal hemoglobinuria and myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML), which are common complications after successful immunosuppressive therapy (IST). With the advent of high-throughput sequencing of recent years, the molecular aspect of CH in AA has been clarified by comprehensive detection of somatic mutations that drive clonal evolution. Genetic abnormalities are found in ∼50% of patients with AA and, except for PIGA mutations and copy-neutral loss-of-heterozygosity, or uniparental disomy (UPD) in 6p (6pUPD), are most frequently represented by mutations involving genes commonly mutated in myeloid malignancies, including DNMT3A, ASXL1, and BCOR/BCORL1. Mutations exhibit distinct chronological profiles and clinical impacts. BCOR/BCORL1 and PIGA mutations tend to disappear or show stable clone size and predict a better response to IST and a significantly better clinical outcome compared with mutations in DNMT3A, ASXL1, and other genes, which are likely to increase their clone size, are associated with a faster progression to MDS/AML, and predict an unfavorable survival. High frequency of 6pUPD and overrepresentation of PIGA and BCOR/BCORL1 mutations are unique to AA, suggesting the role of autoimmunity in clonal selection. By contrast, DNMT3A and ASXL1 mutations, also commonly seen in CH in the general population, indicate a close link to CH in the aged bone marrow, in terms of the mechanism for selection. Detection and close monitoring of somatic mutations/evolution may help with prediction and diagnosis of clonal evolution of MDS/AML and better management of patients with AA. PMID:27121470

Clinical use of closed-system safety peripheral intravenous cannulas.

PubMed

Barton, Andrew

2018-04-26

Peripheral intravenous (IV) cannulas are the quickest and most effective way of gaining venous vascular access and administering IV therapy. Closed-system peripheral IV cannulas have been shown to be safe and more reliable than open, non-valved peripheral cannulas in clinical practice. This article introduces the Smiths Medical DeltaVen closed-system peripheral IV cannula and includes three case studies describing its use in clinical practice and associated patient outcomes.

Close-range photogrammetry in underground mining ground control

NASA Astrophysics Data System (ADS)

Benton, Donovan J.; Chambers, Amy J.; Raffaldi, Michael J.; Finley, Seth A.; Powers, Mark J.

2016-09-01

Monitoring underground mine deformation and support conditions has traditionally involved visual inspection and geotechnical instrumentation. Monitoring displacements with conventional instrumentation can be expensive and time-consuming, and the number of locations that can be effectively monitored is generally limited. Moreover, conventional methods typically produce vector rather than tensor descriptions of geometry changes. Tensor descriptions can provide greater insight into hazardous ground movements, particularly in recently excavated openings and in older workings that have been negatively impacted by high stress concentrations, time-dependent deformation, or corrosion of ground support elements. To address these issues, researchers with the National Institute for Occupational Safety and Health, Spokane Mining Research Division are developing and evaluating photogrammetric systems for ground control monitoring applications in underground mines. This research has demonstrated that photogrammetric systems can produce millimeter-level measurements that are comparable to conventional displacement-measuring instruments. This paper provides an overview of the beneficial use of close-range photogrammetry for the following three ground control applications in underground mines: monitoring the deformation of surface support, monitoring rock mass movement, and monitoring the corrosion of surface support. Preliminary field analyses, case studies, limitations, and best practices for these applications are also discussed.

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.

Measured energy savings and performance of power-managed personal computers and monitors

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

Nordman, B.; Piette, M.A.; Kinney, K.

1996-08-01

Personal computers and monitors are estimated to use 14 billion kWh/year of electricity, with power management potentially saving $600 million/year by the year 2000. The effort to capture these savings is lead by the US Environmental Protection Agency`s Energy Star program, which specifies a 30W maximum demand for the computer and for the monitor when in a {open_quote}sleep{close_quote} or idle mode. In this paper the authors discuss measured energy use and estimated savings for power-managed (Energy Star compliant) PCs and monitors. They collected electricity use measurements of six power-managed PCs and monitors in their office and five from two othermore » research projects. The devices are diverse in machine type, use patterns, and context. The analysis method estimates the time spent in each system operating mode (off, low-, and full-power) and combines these with real power measurements to derive hours of use per mode, energy use, and energy savings. Three schedules are explored in the {open_quotes}As-operated,{close_quotes} {open_quotes}Standardized,{close_quotes} and `Maximum` savings estimates. Energy savings are established by comparing the measurements to a baseline with power management disabled. As-operated energy savings for the eleven PCs and monitors ranged from zero to 75 kWh/year. Under the standard operating schedule (on 20% of nights and weekends), the savings are about 200 kWh/year. An audit of power management features and configurations for several dozen Energy Star machines found only 11% of CPU`s fully enabled and about two thirds of monitors were successfully power managed. The highest priority for greater power management savings is to enable monitors, as opposed to CPU`s, since they are generally easier to configure, less likely to interfere with system operation, and have greater savings. The difficulties in properly configuring PCs and monitors is the largest current barrier to achieving the savings potential from power management.« less

Fundamental Physics and Practical Applications of Electromagnetic Local Flow Control in High Speed Flows (Rutgers)

DTIC Science & Technology

2010-02-16

field. Techniques utilizing this design use an open- loop control and no flow monitoring sensors are required. Conversely, reactive (or closed - loop ...and closed (dashed line) configuration. 38 closed configuration described above, the ambiguity in the critical limits of the transition...flow; a new vortex is then shed from the cavity leading edge, closing the feedback loop .[31] Open cavities with an L/D approximately greater than

In vitro lysis and acute transfusion reactions with hemolysis caused by inappropriate storage of canine red blood cell products.

PubMed

Patterson, J; Rousseau, A; Kessler, R J; Giger, U

2011-01-01

Transfusion of red blood cell (RBC) products carries considerable risk for adverse reactions, including life-threatening hemolytic reactions. To report the occurrence and investigation of life-threatening acute transfusion reactions with hemolysis in dogs likely related to inappropriate blood product storage. Four dogs with acute transfusion reactions and other recipients of blood products. Medical records were reviewed from 4 dogs with suspected acute hemolytic transfusion reactions after receiving RBC products at a veterinary clinic over a 1-month period. Medical records of other animals receiving blood products in the same time period also were reviewed. Blood compatibility and product quality were assessed, subsequent transfusions were closely monitored, and products were diligently audited. During or immediately after RBC product transfusion, 4 dogs developed hemolysis, hemoglobinuria, or both. Two dogs died and 1 was euthanized because of progressive clinical signs compatible with an acute hemolytic transfusion reaction. Blood type and blood compatibility were confirmed. RBC units from 2 blood banks were found to be hemolyzed after storage in the clinic's refrigerator; no bacterial contamination was identified. After obtaining a new refrigerator dedicated to blood product storage, the problem of hemolyzed units and acute transfusion reactions with hemolysis completely resolved. Acute life-threatening transfusion reactions can be caused by inappropriate storage of RBC products. In addition to infectious disease screening and ensuring blood-type compatibility, quality assessment of blood products, appropriate collection, processing, and storage techniques as well as recipient monitoring are critical to provide safe, effective transfusions. Copyright © 2011 by the American College of Veterinary Internal Medicine.

Management of Hypoglycemia in Children and Adolescents with Type 1 Diabetes Mellitus.

PubMed

McGill, Dayna E; Levitsky, Lynne L

2016-09-01

Hypoglycemia and fear of hypoglycemia limit appropriate glycemic control in many children and adolescents with type 1 diabetes. Traditional approaches to the prevention of hypoglycemia including patient education about modifiable risk factors for hypoglycemia (changes in insulin, diet, and exercise) and frequency of self glucose monitoring remain important for hypoglycemia prevention. Continuous glucose monitoring systems with or without a partial closed-loop control of insulin infusion have been very useful in the prevention of hypoglycemia. Oral carbohydrate and parenteral glucagon continue to be the mainstays of hypoglycemia treatment. In the future, we can look forward to regulatory approval of closed-loop insulin delivery and glucose monitoring systems to facilitate euglycemia, as well as glucagon administered by the intranasal route to treat hypoglycemia.

A Novel Approach to Monitoring the Curing of Epoxy in Closed Tools by Use of Ultrasonic Spectroscopy

PubMed Central

2017-01-01

The increasing use of composite materials has led to a greater demand for efficient curing cycles to reduce costs and speed up production cycles in manufacturing. One method to achieve this goal is in-line cure monitoring to determine the exact curing time. This article proposes a novel method through which to monitor the curing process inside closed tools by employing ultrasonic spectroscopy. A simple experiment is used to demonstrate the change in the ultrasonic spectrum during the cure cycle of an epoxy. The results clearly reveal a direct correlation between the amplitude and state of cure. The glass transition point is indicated by a global minimum of the reflected amplitude. PMID:29301222

Monitoring spacecraft atmosphere contaminants by laser absorption spectroscopy

NASA Technical Reports Server (NTRS)

Steinfeld, J. I.

1976-01-01

Laser-based spectrophotometric methods which have been proposed for the detection of trace concentrations of gaseous contaminants include Raman backscattering (LIDAR) and passive radiometry (LOPAIR). Remote sensing techniques using laser spectrometry are presented and in particular a simple long-path laser absorption method (LOLA), which is capable of resolving complex mixtures of closely related trace contaminants at ppm levels is discussed. A number of species were selected for study which are representative of those most likely to accumulate in closed environments, such as submarines or long-duration manned space flights. Computer programs were developed which will permit a real-time analysis of the monitored atmosphere. Estimates of the dynamic range of this monitoring technique for various system configurations, and comparison with other methods of analysis, are given.

Architecture of a wireless Personal Assistant for telemedical diabetes care.

PubMed

García-Sáez, Gema; Hernando, M Elena; Martínez-Sarriegui, Iñaki; Rigla, Mercedes; Torralba, Verónica; Brugués, Eulalia; de Leiva, Alberto; Gómez, Enrique J

2009-06-01

Advanced information technologies joined to the increasing use of continuous medical devices for monitoring and treatment, have made possible the definition of a new telemedical diabetes care scenario based on a hand-held Personal Assistant (PA). This paper describes the architecture, functionality and implementation of the PA, which communicates different medical devices in a personal wireless network. The PA is a mobile system for patients with diabetes connected to a telemedical center. The software design follows a modular approach to make the integration of medical devices or new functionalities independent from the rest of its components. Physicians can remotely control medical devices from the telemedicine server through the integration of the Common Object Request Broker Architecture (CORBA) and mobile GPRS communications. Data about PA modules' usage and patients' behavior evaluation come from a pervasive tracing system implemented into the PA. The PA architecture has been technically validated with commercially available medical devices during a clinical experiment for ambulatory monitoring and expert feedback through telemedicine. The clinical experiment has allowed defining patients' patterns of usage and preferred scenarios and it has proved the Personal Assistant's feasibility. The patients showed high acceptability and interest in the system as recorded in the usability and utility questionnaires. Future work will be devoted to the validation of the system with automatic control strategies from the telemedical center as well as with closed-loop control algorithms.

[Cardiovascular circulation feedback control treatment instrument].

PubMed

Ge, Yu-zhi; Zhu, Xing-huan; Sheng, Guo-tai; Cao, Ping-liang; Liu, Dong-sheng; Wu, Zhi-ting

2005-07-01

The cardiovascular circulation feedback control treatment instrument (CFCTI) is an automatic feedback control treatment system, which has the function of monitoring, alarming, trouble self-diagnosis and testing on the line in the closed loop. The instrument is designed based on the successful clinical experiences and the data are inputted into the computer in real-time through a pressure sensor and A/D card. User interface window is set up for the doctor's choosing different medicine. The orders are outputted to control the dose of medicine through the transfusion system. The response to medicine is updated continually. CFCTI can avoid the man-made errors and the long interval of sampling. Its reliability and accuracy in rescuing the critical patients are much higher than the traditional methods.

Myocardial involvement in rocky mountain spotted fever: a case report and review.

PubMed

Doyle, Amy; Bhalla, Karan S; Jones, James M; Ennis, David M

2006-10-01

Rocky Mountain Spotted Fever (RMSF), caused by Rickettia rickettsii, is a serious tickborne illness that is endemic in the southeastern United States. Although it is most commonly known as a cause of fever and rash, it can have systemic manifestations. The myocardium may rarely be involved, with symptoms that can mimic those of acute coronary syndromes. This report describes a case of serologically proven RMSF causing symptomatic myocarditis, manifested by chest pain, elevated cardiac enzyme levels, and decrease myocardial function. After treatment with antibiotics, the myocarditis resolved. Thus, although unusual, the clinician should be aware of myocardial disease in patients with appropriate exposure histories or other clinical signs of RMSF. Close monitoring and an aggressive approach are essential to reduce mortality rates.

Epstein-Barr virus: general factors, virus-related diseases and measurement of viral load after transplant

PubMed Central

Gequelin, Luciana Cristina Fagundes; Riediger, Irina N.; Nakatani, Sueli M.; Biondo, Alexander W.; Bonfim, Carmem M.

2011-01-01

The Epstein-Barr virus is responsible for infectious mononucleosis syndrome and is also closely associated to several types of cancer. The main complication involving Epstein-Barr virus infection, both in recipients of hematopoietic stem cells and solid organs, is post-transplant lymphoproliferative disease. The importance of this disease has increased interest in the development of laboratory tools to improve post-transplant monitoring and to detect the disease before clinical evolution. Viral load analysis for Epstein-Barr virus through real-time polymerase chain reaction is, at present, the best tool to measure viral load. However, there is not a consensus on which sample type is the best for the test and what is its predictive value for therapeutic interventions. PMID:23049344

Treatment for a eumycetoma infection caused by Aspergillus in an immunocompromised host: a case report.

PubMed

Hopps, S; Roach, A; Yuen, C; Borders, E

2015-02-01

Eumycetoma is a chronic infection of the skin and subcutaneous tissue caused by filamentous fungi, which usually occurs in tropical or subtropical countries. We report a case of an immunocompromised patient presenting with presumed eumycetoma in the United States and his subsequent treatment with voriconazole. The use of voriconazole and liposomal amphotericin B halted the progression and allowed gradual resolution of the infection. The patient will require close monitoring and long-term therapy with voriconazole to obtain a clinical cure. Voriconazole and liposomal amphotericin B are potential initial treatment options, with long-term voriconazole maintenance therapy, for an Aspergillus-induced eumycetoma. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Probe-pin device for optical neurotransmitter sensing in the brain

NASA Astrophysics Data System (ADS)

Kim, Min Hyuck; Song, Kyo D.; Yoon, Hargsoon; Park, Yeonjoon; Choi, Sang H.; Lee, Dae-Sung; Shin, Kyu-Sik; Hwang, Hak-In; Lee, Uhn

2015-04-01

Development of an optical neurotransmitter sensing device using nano-plasmonic probes and a micro-spectrometer for real time monitoring of neural signals in the brain is underway. Clinical application of this device technology is to provide autonomous closed-loop feedback control to a deep brain stimulation (DBS) system and enhance the accuracy and efficacy of DBS treatment. By far, we have developed an implantable probe-pin device based on localized field enhancement of surface plasmonic resonance on a nanostructured sensing domain which can amplify neurochemical signals from evoked neural activity in the brain. In this paper, we will introduce the details of design and sensing performance of a proto-typed microspectrometer and nanostructured probing devices for real time measurement of neurotransmitter concentrations.

Effectiveness of varicella vaccine in children infected with HIV.

PubMed

Son, Moeun; Shapiro, Eugene D; LaRussa, Philip; Neu, Natalie; Michalik, David E; Meglin, Michelle; Jurgrau, Andrea; Bitar, Wally; Vasquez, Marietta; Flynn, Patricia; Gershon, Anne A

2010-06-15

Although varicella vaccine is given to clinically stable human immunodeficiency virus (HIV)-infected children, its effectiveness is unknown. We assessed its effectiveness by reviewing the medical records of closely monitored HIV-infected children, including those receiving highly active antiretroviral therapy (HAART) between 1989 and 2007. Varicella immunization and development of varicella or herpes zoster were noted. Effectiveness was calculated by subtracting from 1 the rate ratios for the incidence rates of varicella or herpes zoster in vaccinated versus unvaccinated children. The effectiveness of the vaccine was 82% (95% confidence interval [CI], 24%-99%; P = .01) against varicella and was 100% (95% CI, 67%-100%; P < .001) against herpes zoster. When the analysis was controlled for receipt of HAART, vaccination remained highly protective against herpes zoster.

Monitoring of natural outbreaks of Phytophthora ramorum in the United Kingdom.

Treesearch

Judith Turner; Alex Appiah; Philip Jennings; Gilli Humphries; Debbie Liddell; Sam McDonough; Jackie Stonehouse; David Lockley; Stephen Eales

2006-01-01

Over 40 outbreaks of Phytophthora ramorum have occurred in managed gardens in the United Kingdom. Three of these sites, one in the southeast of England and two in the southwest, have been closely monitored since October 2003. These sites represented differing disease scenarios at the start of monitoring, as eradication action had already taken...

Intraorbital foreign body projectile as a consideration for unilateral pupillary defect

PubMed Central

2012-01-01

Intraorbital foreign bodies are frequently the result of high-velocity injuries with varying clinical presentations. The resultant diagnosis, management, and outcome depend on the type of foreign body present, anatomical location, tissue disruption, and symptomatology. A patient who presented to the Emergency Department with a large intraorbital foreign body projectile that was not evident clinically, but found incidentally on computed tomography and subsequent plain films is reported. The emergency room physician needs to be aware of the differential diagnosis of a unilateral irregular pupil with or without visual acuity changes. The differential diagnosis for any trauma patient with an irregular pupil with significant visual loss must include intraorbital foreign body and associated injury to the optic nerve directly or via orbital compartment syndrome secondary to hemorrhage and/or edema. Patients with significantly decreased visual acuity may benefit from emergent surgical intervention. In patients with intact visual acuity, the patient must be monitored closely for any visual changes as this may require emergent surgical intervention. PMID:22390406

Clinical Manifestations of an Anti-Drug Antibody Response: Autoimmune Reactions.

PubMed

Swanson, Steven J

2014-12-01

Antibodies can be generated against a therapeutic protein upon administration to human subjects. When the therapeutic protein closely mimics one of the subject's endogenous proteins, those antibodies might bind to the endogenous protein in addition to the therapeutic protein. This scenario results when tolerance to the endogenous protein is broken. The consequences of breaking tolerance include an autoimmune response where antibodies are generated against the endogenous protein. These autoantibodies could have significant clinical relevance depending on several factors, including the redundancy of action of the endogenous protein as well as the concentration, binding affinity, and neutralizing potential of the antibodies. The consequences of a therapeutic-protein-induced autoimmune reaction can be challenging to manage as the stimulus for further perpetuation of the immune response can shift from the therapeutic protein to the endogenous protein. The potential for inducing an autoimmune response is one of the reasons that the immune response to a therapeutic protein should be monitored if it persists through the end of the study.

Role of cognitive parameters in dengue hemorrhagic fever and dengue shock syndrome

PubMed Central

2013-01-01

Dengue is becoming recognized as one of the most important vector-borne human diseases. It is predominant in tropical and subtropical zones but its geographical distribution is progressively expanding, making it an escalating global health problem of today. Dengue presents with spectrum of clinical manifestations, ranging from asymptomatic, undifferentiated mild fever, dengue fever (DF), to dengue hemorrhagic fever (DHF) with or without shock (DSS), a life-threatening illness characterized by plasma leakage due to increased vascular permeability. Currently, there are no antiviral modalities or vaccines available to treat and prevent dengue. Supportive care with close monitoring is the standard clinical practice. The mechanisms leading to DHF/DSS remains poorly understood. Multiple factors have been attributed to the pathological mechanism, but only a couple of these hypotheses are popular in scientific circles. The current discussion focuses on underappreciated factors, temperature, natural IgM, and endotoxin, which may be critical components playing roles in dengue pathogenesis. PMID:24305068

Clinical perspective: creating an effective practice peer review process-a primer.

PubMed

Gandhi, Manisha; Louis, Frances S; Wilson, Shae H; Clark, Steven L

2017-03-01

Peer review serves as an important adjunct to other hospital quality and safety programs. Despite its importance, the available literature contains virtually no guidance regarding the structure and function of effective peer review committees. This Clinical Perspective provides a summary of the purposes, structure, and functioning of effective peer review committees. We also discuss important legal considerations that are a necessary component of such processes. This discussion includes useful templates for case selection and review. Proper committee structure, membership, work flow, and leadership as well as close cooperation with the hospital medical executive committee and legal representatives are essential to any effective peer review process. A thoughtful, fair, systematic, and organized approach to creating a peer review process will lead to confidence in the committee by providers, hospital leadership, and patients. If properly constructed, such committees may also assist in monitoring and enforcing compliance with departmental protocols, thus reducing harm and promoting high-quality practice. Copyright © 2016 Elsevier Inc. All rights reserved.

[Prevention and management of refeeding syndrome in patients with chronic critical illness].

PubMed

Chen, Jun; Fan, Chaogang

2016-07-01

Nutritional support is an important means to treat the patients with chronic critical illness for commonly associated malnutrition. Refeeding syndrome is a serious complication during the process, mainly manifested as severe electrolyte with hypophosphataemia being the most common. Refeeding syndrome is not uncommon but it is often ignored. In our future clinical work, we need to recognize this chinical situation and use preventative and treatment measures. According to NICE clinical nutrition guideline, we discussed the risk factors, treatment methods and preventive measures of refeeding syndrome in patients with chronic critical illness. We argued that for patients with high risk refeeding syndrome, nutritional support treatment should be initially low calorie and slowly increased to complete requirement. Circulation capacity should be recovered, fluid balance must be closely monitored and supplement of vitamins, microelement, electrolytes should be noted. After the emergence of refeeding syndrome, we should reduce or even stop the calorie intake, give an active treatment for electrolyte disorder, provide vitamin B, and maintain the functions of multiple organs.

Refeeding syndrome: clinical and nutritional relevance.

PubMed

Viana, Larissa de Andrade; Burgos, Maria Goretti Pessoa de Araújo; Silva, Rafaella de Andrade

2012-01-01

Feedback syndrome is characterized clinically by neurological alterations, respiratory symptoms, arrhythmias and heart failure few days after refeeding. It happens due to severe electrolyte changes, such as hypophosphatemia, hypomagnesemia and hypokalemia associated with metabolic abnormalities that may occur as a result of nutritional support (oral, enteral or parenteral) in severely malnourished patients. To evaluate its causes and the preventive dietary measures aiming to reduce the morbimortality. Was conducted literature review in SciELO, LILACS, Medline / PUBMED, Cochrane Library and government websites in Portuguese, English and Spanish. The survey was about the last 15 years, selecting the headings: refeeding syndrome, malnutrition, hypophosphatemia, hypokalemia, hypomagnesemia. The monitoring of metabolic parameters and electrolyte levels before starting nutritional support and periodically during feeding should be based on protocols and the duration of therapy. Patients at high risk and other metabolic complications should be followed closely, and depletion of minerals and electrolytes should be replaced before starting the diet. A multidisciplinary team of nutrition therapy can guide and educate other health professionals in prevention, diagnosis and treatment of the syndrome.

Medical management of neurocysticercosis.

PubMed

Takayanagui, Osvaldo Massaiti; Odashima, Newton Satoru; Bonato, Pierina S; Lima, Jose Eduardo; Lanchote, Vera Lucia

2011-12-01

Neurocysticercosis (NCC) is considered to be the most common cause of acquired epilepsy worldwide. Formerly restricted to palliative measures, therapy for NCC has advanced with the advent of two drugs that are considered to be effective: praziquantel (PZQ) and albendazole (ALB). All available articles regarding research related to the treatment of NCC were searched. Relevant articles were then reviewed and used as sources of information for this review. Anticysticercal therapy has been marked by intense controversy. Recent descriptions of spontaneous resolution of parenchymal cysticercosis with benign evolution, risks of complications and reports of no long-term benefits have reinforced the debate over the usefulness and safety of anticysticercal therapy. High interindividual variability and complex pharmacological interactions will require the close monitoring of plasma concentrations of ALB and PZQ metabolites in future trials. Given the relative scarcity of clinical trials, more comparative interventional studies - especially randomized controlled trials in long-term clinical evolution - are required to clarify the controversy over the validity of parasitic therapy in patients with NCC.

Use of an attenuated live Salmonella Typhimurium vaccine on three breeding pig units: A longitudinal observational field study.

PubMed

Davies, R; Gosling, R J; Wales, A D; Smith, R P

2016-06-01

The study examined the effects of a licensed live Salmonella Typhimurium vaccine, administered to sows and gilts on three commercial pig units experiencing clinical salmonellosis associated with S. Typhimurium or its monophasic variant. After vaccination, clinical salmonellosis resolved and shedding of S. Typhimurium declined markedly and persistently on all breeding or breeding-finishing units, during the one- to two-year monitoring period. On two finishing units supplied in part by one of the vaccinated herds, pigs from the vaccinated herd were less likely to shed Salmonella than those from non-vaccinating herds, and Salmonella counts in faeces were also lower from the vaccine-linked animals. Non-Typhimurium Salmonella serovars were isolated typically in fewer than 10% of samples, and showed no clear temporal changes in frequency. Vaccination of dams alone with S. Typhimurium was associated with reduced shedding of closely-related serovars among all age groups in this commercial setting. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Bayesian accrual prediction for interim review of clinical studies: open source R package and smartphone application.

PubMed

Jiang, Yu; Guarino, Peter; Ma, Shuangge; Simon, Steve; Mayo, Matthew S; Raghavan, Rama; Gajewski, Byron J

2016-07-22

Subject recruitment for medical research is challenging. Slow patient accrual leads to increased costs and delays in treatment advances. Researchers need reliable tools to manage and predict the accrual rate. The previously developed Bayesian method integrates researchers' experience on former trials and data from an ongoing study, providing a reliable prediction of accrual rate for clinical studies. In this paper, we present a user-friendly graphical user interface program developed in R. A closed-form solution for the total subjects that can be recruited within a fixed time is derived. We also present a built-in Android system using Java for web browsers and mobile devices. Using the accrual software, we re-evaluated the Veteran Affairs Cooperative Studies Program 558- ROBOTICS study. The application of the software in monitoring and management of recruitment is illustrated for different stages of the trial. This developed accrual software provides a more convenient platform for estimation and prediction of the accrual process.

Impact of the priority follow-up system on quality of life in Chinese schizophrenia patients.

PubMed

Xiang, Yu-Tao; Leung, Chi-Ming; Tang, Wai-Kwong; Ungvari, Gabor Sandor

2008-02-01

Priority follow up (PFU) is a particular aspect of mental health care in Hong Kong whereby psychiatric patients with a history of violence or suspected proclivity to violence are identified and their management is closely monitored. The aim of the present study was to determine the impact of a PFU system on quality of life (QOL) in schizophrenia patients. Two hundred and sixty-seven clinically stable outpatients with schizophrenia were randomly selected and interviewed in Hong Kong using standardized assessment instruments that covered their clinical condition and QOL. Patients with PFU status constituted 8.2% of the sample. PFU patients were more likely to be men, have a history of violence, and were poorer in the physical, psychological, social and environmental QOL domains than their non-PFU counterparts even after controlling for the effects of potential confounding variables. More effective measures should be taken to improve QOL in PFU schizophrenia patients who are prone to violent behavior.

Clinical use of anti-TNF therapy and increased risk of infections

PubMed Central

Ali, Tauseef; Kaitha, Sindhu; Mahmood, Sultan; Ftesi, Abdul; Stone, Jordan; Bronze, Michael S

2013-01-01

Biologics such as antitumor necrosis factor (anti-TNF) drugs have emerged as important agents in the treatment of many chronic inflammatory diseases, especially in cases refractory to conventional treatment modalities. However, opportunistic infections have become a major safety concern in patients on anti-TNF therapy, and physicians who utilize these agents must understand the increased risks of infection. A literature review of the published data on the risk of bacterial, viral, fungal, and parasitic infections associated with anti-TNF therapy was performed and the clinical presentation, diagnostic tests, management, and prevention of opportunistic infections in patients receiving anti-TNF therapy were reviewed. Awareness of the therapeutic potential and associated adverse events is necessary for maximizing therapeutic benefits while minimizing adverse effects from anti-TNF treatments. Patients should be adequately vaccinated when possible and closely monitored for early signs of infection. When serious infections occur, withdrawal of anti-TNF therapy may be necessary until the infection has been identified and properly treated. PMID:23569399

Phenytoin kinetics during pregnancy and the puerperium.

PubMed

Knott, C; Williams, C P; Reynolds, F

1986-10-01

During pregnancy changes in maternal physiology and plasma composition may alter drug binding and dose requirements. We have measured plasma unbound and total phenytoin, and saliva concentrations at intervals in 11 pregnant epileptics. Plasma albumin concentrations were also measured in pregnant and non-pregnant women. Saliva phenytoin correlated closely with the plasma unbound concentrations (r = 0.98). The saliva:plasma (S:P) ratio, reflecting the free fraction, was variable during pregnancy but tended to increase to maximal values at delivery and return to non-pregnant values within 2-8 weeks thereafter. Plasma albumin concentrations correlated poorly with phenytoin binding. Binding in umbilical cord plasma appeared higher than that in maternal plasma and total fetal concentrations correlated closely with maternal plasma concentrations at delivery. No ill effects of phenytoin were detected in the newborn infant. During the third trimester phenytoin dose increments were necessary to maintain therapeutic concentrations. After delivery maternal saliva phenytoin concentrations rose, and dose reductions were necessary to avoid clinical symptoms of toxicity. It is therefore appropriate to monitor saliva phenytoin concentrations regularly both during pregnancy and the puerperium.

78 FR 62884 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

... review functions focused on: (1) Manipulation patterns that monitor solely BX activity, including patterns that monitor the opening and closing crosses on The NASDAQ Stock Market LLC (``NASDAQ'') and...

Closed circuit TV system monitors welding operations

NASA Technical Reports Server (NTRS)

Gilman, M.

1967-01-01

TV camera system that has a special vidicon tube with a gradient density filter is used in remote monitoring of TIG welding of stainless steel. The welding operations involve complex assembly welding tools and skates in areas of limited accessibility.

Nerve damage related to implant dentistry: incidence, diagnosis, and management.

PubMed

Greenstein, Gary; Carpentieri, Joseph R; Cavallaro, John

2015-10-01

Proper patient selection and treatment planning with respect to dental implant placement can preclude nerve injuries. Nevertheless, procedures associated with implant insertion can inadvertently result in damage to branches of the trigeminal nerve. Nerve damage may be transient or permanent; this finding will depend on the cause and extent of the injury. Nerve wounding may result in anesthesia, paresthesia, or dysesthesia. The type of therapy to ameliorate the condition will be dictated by clinical and radiographic assessments. Treatment may include monitoring altered sensations to see if they subside, pharmacotherapy, implant removal, reverse-torquing an implant to decompress a nerve, combinations of the previous therapies, and/or referral to a microsurgeon for nerve repair. Patients manifesting altered sensations due to various injuries require different therapies. Transection of a nerve dictates immediate referral to a microsurgeon for evaluation. If a nerve is compressed by an implant or adjacent bone, the implant should be reverse-torqued away from the nerve or removed. When an implant is not close to a nerve, but the patient is symptomatic, the patient can be monitored and treated pharmacologically as long as symptoms improve or the implant can be removed. There are diverse opinions in the literature concerning how long an injured patient should be monitored before being referred to a microsurgeon.

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

Teaching and learning in out-patient clinics.

PubMed

Williamson, James

2012-10-01

Out-patient clinics offer trainees one of the most varied clinical experiences within the hospital setting, but they are often chaotic and over-stretched, with limited time for teaching. An awareness of how to improve this learning environment by both trainers and trainees may enhance learning opportunities. Clinical supervisors need to balance educational and service commitments, while maintaining a high quality of patient care. Supervision features observation and the sharing of clinical and continual feedback, which can improve clinical performance. Trainers must closely monitor the abilities of the trainee and gradually increase their responsibility and clinical load. The application of learning theory to the workplace can improve learning opportunities. Trainers should have some control over the environment, both the physical attributes (room availability, staffing levels and allocated consultation time) and the harder to measure aspects, such as the ethos of the department and attitudes to teaching. The creation of a community of practice within out-patient clinics can strengthen both the collective knowledge of the team and its role in treating patients. The active involvement of trainees within this social environment (for example, by performing independent consultations) validates their role in the care of patients and enhances their learning. To maximise the learning opportunities within out-patient clinics there needs to be a shift in culture to promote learning in a safe and non-threatening environment. The establishment of a community of practice may validate the role of trainees in the management of patients and facilitate social learning by all members of the clinical team. © Blackwell Publishing Ltd 2012.

Intraoperative dorsal language network mapping by using single-pulse electrical stimulation.

PubMed

Yamao, Yukihiro; Matsumoto, Riki; Kunieda, Takeharu; Arakawa, Yoshiki; Kobayashi, Katsuya; Usami, Kiyohide; Shibata, Sumiya; Kikuchi, Takayuki; Sawamoto, Nobukatsu; Mikuni, Nobuhiro; Ikeda, Akio; Fukuyama, Hidenao; Miyamoto, Susumu

2014-09-01

The preservation of language function during brain surgery still poses a challenge. No intraoperative methods have been established to monitor the language network reliably. We aimed to establish intraoperative language network monitoring by means of cortico-cortical evoked potentials (CCEPs). Subjects were six patients with tumors located close to the arcuate fasciculus (AF) in the language-dominant left hemisphere. Under general anesthesia, the anterior perisylvian language area (AL) was first defined by the CCEP connectivity patterns between the ventrolateral frontal and temporoparietal area, and also by presurgical neuroimaging findings. We then monitored the integrity of the language network by stimulating AL and by recording CCEPs from the posterior perisylvian language area (PL) consecutively during both general anesthesia and awake condition. High-frequency electrical stimulation (ES) performed during awake craniotomy confirmed language function at AL in all six patients. Despite an amplitude decline (≤32%) in two patients, CCEP monitoring successfully prevented persistent language impairment. After tumor removal, single-pulse ES was applied to the white matter tract beneath the floor of the removal cavity in five patients, in order to trace its connections into the language cortices. In three patients in whom high-frequency ES of the white matter produced naming impairment, this "eloquent" subcortical site directly connected AL and PL, judging from the latencies and distributions of cortico- and subcortico-cortical evoked potentials. In conclusion, this study provided the direct evidence that AL, PL, and AF constitute the dorsal language network. Intraoperative CCEP monitoring is clinically useful for evaluating the integrity of the language network. Copyright © 2014 Wiley Periodicals, Inc.

Usefulness of simultaneous and sequential monitoring of glucose level and electrocardiogram in monkeys treated with gatifloxacin under conscious and nonrestricted conditions.

PubMed

Yoshimatsu, Yu; Ishizaka, Tomomichi; Chiba, Katsuyoshi; Mori, Kazuhiko

2018-05-10

Drug-induced cardiac electrophysiological abnormalities accompanied by hypoglycemia or hyperglycemia increase the risk for life-threatening arrhythmia. To assess the drug-induced cardiotoxic potential associated with extraordinary blood glucose (GLU) levels, the effect of gatifloxacin (GFLX) which was frequently associated with GLU abnormality and QT/QTc prolongations in the clinic on blood GLU and electrocardiogram (ECG) parameters was investigated in cynomolgus monkeys (n=4) given GFLX orally in an ascending dose regimen (10, 30, 60 and 100 mg/kg). Simultaneous and sequential GLU and ECG monitoring with a continuous GLU monitoring system and Holter ECG, respectively, were conducted for 24 h under free-moving conditions. Consequently, GFLX at 30 and 60 mg/kg dose-dependently induced a transient decrease in GLU without any ECG abnormality 2-4 h postdose. Highest dose of 100 mg/kg caused severe hypoglycemia with a mean GLU of <30 mg/dL, accompanied by remarkable QT/QTc prolongations by 20-30% in all animals. In contrast, hyperglycemia without QT/QTc prolongations was noted 24 h after dosing in one animal. A close correlation between GLU and QTc values was observed in animals treated with 100 mg/kg, suggesting that GFLX-induced hypoglycemia enhanced QT/QTc prolongations. Furthermore, the 24-h sequential GLU monitoring data clearly distinguished between GFLX-induced GLU abnormality and physiological GLU changes influenced by feeding throughout the day. In conclusion, the combined assessment of continuous GLU and ECG monitoring is valuable in predicting the drug-induced cardio-electrophysiological risk associated with both GLU and ECG abnormalities.

Collection of liquid from below-ground location

DOEpatents

Phillips, S.J.; Alexander, R.G.

1995-05-30

A method is described for retrieving liquid from a below-ground collection area by permitting gravity flow of the liquid from the collection area to a first closed container; monitoring the level of the liquid in the closed container; and after the liquid reaches a given level in the first closed container, transferring the liquid to a second closed container disposed at a location above the first closed container, via a conduit, by introducing into the first closed container a gas which is substantially chemically inert with respect to the liquid, the gas being at a pressure sufficient to propel the liquid from the first closed container to the second closed container. 3 figs.

Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa

PubMed Central

Bor, Jacob; Tanser, Frank; Bärnighausen, Till

2017-01-01

Background Loss to follow-up is high among HIV patients not yet receiving antiretroviral therapy (ART). Clinical trials have demonstrated the clinical efficacy of early ART; however, these trials may miss an important real-world consequence of providing ART at diagnosis: its impact on retention in care. Methods and findings We examined the effect of immediate (versus deferred) ART on retention in care using a regression discontinuity design. The analysis included all patients (N = 11,306) entering clinical HIV care with a first CD4 count between 12 August 2011 and 31 December 2012 in a public-sector HIV care and treatment program in rural South Africa. Patients were assigned to immediate versus deferred ART eligibility, as determined by a CD4 count < 350 cells/μl, per South African national guidelines. Patients referred to pre-ART care were instructed to return every 6 months for CD4 monitoring. Patients initiated on ART were instructed to return at 6 and 12 months post-initiation and annually thereafter for CD4 and viral load monitoring. We assessed retention in HIV care at 12 months, as measured by the presence of a clinic visit, lab test, or ART initiation 6 to 18 months after initial CD4 test. Differences in retention between patients presenting with CD4 counts just above versus just below the 350-cells/μl threshold were estimated using local linear regression models with a data-driven bandwidth and with the algorithm for selecting the bandwidth chosen ex ante. Among patients with CD4 counts close to the 350-cells/μl threshold, having an ART-eligible CD4 count (<350 cells/μl) was associated with higher 12-month retention than not having an ART-eligible CD4 count (50% versus 32%), an intention-to-treat risk difference of 18 percentage points (95% CI 11 to 23; p < 0.001). The decision to start ART was determined by CD4 count for one in four patients (25%) presenting close to the eligibility threshold (95% CI 20% to 31%; p < 0.001). In this subpopulation, having an ART-eligible CD4 count was associated with higher 12-month retention than not having an ART-eligible CD4 count (91% versus 21%), a complier causal risk difference of 70 percentage points (95% CI 42 to 98; p < 0.001). The major limitations of the study are the potential for limited generalizability, the potential for outcome misclassification, and the absence of data on longer-term health outcomes. Conclusions Patients who were eligible for immediate ART had dramatically higher retention in HIV care than patients who just missed the CD4-count eligibility cutoff. The clinical and population health benefits of offering immediate ART regardless of CD4 count may be larger than suggested by clinical trials. PMID:29182641

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.

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

Clinical applications of exhaled nitric oxide for the diagnosis and management of asthma: a consensus report.

PubMed

Zitt, Myron

2005-08-01

Patients with asthma routinely exhibit elevated levels of fractionated exhaled nitric oxide (FE(NO)), and this observation has led to studies investigating FE(NO) as a potential marker of airway inflammation. FE(NO) has been shown to enhance the diagnosis of asthma, detect deterioration in control of patients with asthma, and monitor response to anti-inflammatory therapy. The aim of this work was to determine if FE(NO) measurement provides a noninvasive, well-tolerated, and standardized technique to monitor airway inflammation, and if it has the potential to complement standard asthma monitoring tools (eg, symptom diaries, control questionnaires, and pulmonary function testing) and to improve asthma control and patient outcomes. Thirteen experts in the diagnosis and treatment of asthma met to discuss the use of FE(NO) in the diagnosis and management of patients with asthma. Participants were selected by Aerocrine, a medical, technical company with headquarters in Stockholm, Sweden, in consultation with their medical education partner Cadent Medical Communications located in Irving, Texas, to represent a diversity of specialists, including both clinicians and investigators, in the fields of allergy, immunology, and pulmonology. All participants were nominally compensated for their time to attend this closed scientific roundtable discussion. The meeting was supported by an educational grant from Aerocrine. This report represents the overall consensus reached by the participants on the clinical applicability of this technique. Our understanding of asthma has expanded so that investigators are now focusing on inflammation in addition to airway obstruction and hyper-reactivity. Whereas patient history, symptoms, and pulmonary function testing can assist in diagnosing asthma, they are not direct measures of the extent of airway inflammation. Elevated FE(NO) levels have been shown to reflect airway inflammation and to occur together with other conventional markers used to detect inflammation. Studies have confirmed increased levels of FE(NO) in both adults and children with asthma. In most studies, FE(NO) was found to be elevated 2- to 3-fold compared with normal controls. There are many determinants of FE(NO) levels, however, and factors other than inflammation must be considered when FE(NO) measurement is used to diagnose and monitor asthma. FE(NO) measurement alone is not sufficient for diagnosing or monitoring asthma, but it can be a valuable addition to current clinical tools. FE(NO) measurement is a noninvasive and reproducible test that is a surrogate measure of airway inflammation in patients with asthma. The test has demonstrated utility in diagnosing and managing asthma and in predicting response to therapy and, therefore, may be an important tool to incorporate into clinical care.

OVERSEER: An Expert System Monitor for the Psychiatric Hospital

PubMed Central

Bronzino, Joseph D.; Morelli, Ralph A.; Goethe, John W.

1988-01-01

In order to improve patient care, comply with regulatory guidelines and decrease potential liability, psychiatric hospitals and clinics have been searching for computer systems to monitor the management and treatment of patients. This paper describes OVERSEER: a knowledge based system that monitors the treatment of psychiatric patients in real time. Based on procedures and protocols developed in the psychiatric setting, OVERSEER monitors the clinical database and issues alerts when standard clinical practices are not followed or when laboratory results or other clinical indicators are abnormal. Written in PROLOG, OVERSEER is designed to interface directly with the hospital's database, and, thereby utilizes all available pharmacy and laboratory data. Moreover, unlike the interactive expert systems developed for the psychiatric clinic, OVERSEER does not require extensive data entry by the clinician. Consequently, the chief benefit of OVERSEER's monitoring approach is the unobtrusive manner in which it evaluates treatment and patient responses and provides information regarding patient management.

Closed culture plant studies: Implications for CELSS

NASA Technical Reports Server (NTRS)

Hoshizaki, T.

1986-01-01

Arabidopsis plants were grown in closed cultures similar to those used in space experiments. A shift in metabolism from photosynthesis to respiration is indicated by the accumulation of CO2 in the culture atmosphere. Reproductive growth is suppressed. Plant growth and development is apparently related to the atmospheric volume available to each plant. The implications of these findings to closed ecological systems are given: (1) there is a need for an open culture having ample gas exchange, (2) CO2 levels must be maintained within prescribed limits, (3) the minimum atmospheric volume required for each plant is dependent on the precision of the gas monitors and of the subsystems used to maintain appropriate levels of various atmospheric components, and (4) volatiles such as ethylene and terpenes emanating from plants be monitored and reduced to benign concentrations.

Pivot/Remote: a distributed database for remote data entry in multi-center clinical trials.

PubMed

Higgins, S B; Jiang, K; Plummer, W D; Edens, T R; Stroud, M J; Swindell, B B; Wheeler, A P; Bernard, G R

1995-01-01

1. INTRODUCTION. Data collection is a critical component of multi-center clinical trials. Clinical trials conducted in intensive care units (ICU) are even more difficult because the acute nature of illnesses in ICU settings requires that masses of data be collected in a short time. More than a thousand data points are routinely collected for each study patient. The majority of clinical trials are still "paper-based," even if a remote data entry (RDE) system is utilized. The typical RDE system consists of a computer housed in the CC office and connected by modem to a centralized data coordinating center (DCC). Study data must first be recorded on a paper case report form (CRF), transcribed into the RDE system, and transmitted to the DCC. This approach requires additional monitoring since both the paper CRF and study database must be verified. The paper-based RDE system cannot take full advantage of automatic data checking routines. Much of the effort (and expense) of a clinical trial is ensuring that study data matches the original patient data. 2. METHODS. We have developed an RDE system, Pivot/Remote, that eliminates the need for paper-based CRFs. It creates an innovative, distributed database. The database resides partially at the study clinical centers (CC) and at the DCC. Pivot/Remote is descended from technology introduced with Pivot [1]. Study data is collected at the bedside with laptop computers. A graphical user interface (GUI) allows the display of electronic CRFs that closely mimic the normal paper-based forms. Data entry time is the same as for paper CRFs. Pull-down menus, displaying the possible responses, simplify the process of entering data. Edit checks are performed on most data items. For example, entered dates must conform to some temporal logic imposed by the study. Data must conform to some acceptable range of values. Calculations, such as computing the subject's age or the APACHE II score, are automatically made as the data is entered. Data that is collected serially (BP, HR, etc.) can be displayed graphically in a trend form along with other related variables. An audit trail is created that automatically tracks all changes to the original data, making it possible to reconstruct the CRF to any point in time. On-line help provides information on the study protocol as well as assistance with the use of the system. Electronic security makes it possible to lock certain parts of the CRF once it has been monitored. Completed CRFs are transmitted to the DCC via electronic mail where it is reviewed and merged into the study database. Questions about subject data are transmitted back to the CC via electronic mail. This approach to maintaining the study database is unique in that the study data files are distributed among the CC and DCC. Until a subject's CRF is monitored (verified against the original patient data residing in the hospital record), it logically resides at the CC where it was collected. Copies are transmitted to the DCC and are only read there. Any pre-monitoring changes must be made to the data at the CC. Once the subject's CRF is monitored, it logically moves to the DCC, and any subsequent changes are made at the DCC with copies of the CRF flowing back to the CC. 3. DISCUSSION. Pivot/Remote eliminates the need for paper forms by utilizing portable computers that can be used at the patient bedside. A GUI makes it possible to quickly enter data. Because the user gets instant feedback on possible error conditions, time is saved because the original data is close at hand. The ability to display trended data or variables in the context of other data allows detection of erroneous conditions beyond simple range checks. The logical construction of the database minimizes the problem of managing dual databases (at the CC and DCC) and keeps CC personnel in the loop until all changes are made.

Diabetes and technology in 2030: a utopian or dystopian future?

PubMed

Kerr, D; Axelrod, C; Hoppe, C; Klonoff, D C

2018-04-01

The ability of an individual living with diabetes to have human-to-human contact with their healthcare provider is not keeping pace with the number of people developing diabetes. From a futurist perspective, however, this dichotomy of diabetes care represents an opportunity for digital healthcare. The focus of technological innovation is unlikely to be the replacement of the multidisciplinary diabetes team but rather the provision of meaningful individual and family support between clinic visits and, on a larger scale, the facilitation of population health management for diabetes. We can also expect to see new therapies, including implantable drug delivery systems, automated closed-loop systems and miniaturized non-invasive glucose monitoring systems. New digital health technologies will create a 'digital diabetes ecosystem' to enhance rather than devolve care from humans. Concerns related to data privacy and ownership will inevitably rise, thus a future for diabetes care relying heavily on technology is not inevitably utopian. Nevertheless, revolutions in the development of novel sensors, accumulation of 'big data', and use of artificial intelligence will provide exciting opportunities for preventing, monitoring and treating diabetes in the near future. © 2018 Diabetes UK.

Clinical Application of Liquid Biopsy in Targeted Therapy of Metastatic Colorectal Cancer

PubMed Central

Trojan, Jörg; Klein-Scory, Susanne; Koch, Christine; Schmiegel, Wolff

2017-01-01

Background. Colorectal cancers (CRC) shed DNA into blood circulation. There is growing evidence that the analysis of circulating tumor DNA can be effectively used for monitoring of disease, to track tumor heterogeneity and to evaluate response to treatment. Case Presentation. Here, we describe two cases of patients with advanced CRC. The first case is about a patient with no available tissue for analysis of RAS mutation status. Liquid biopsy revealed RAS-wild-type and the therapy with anti-EGFR (epidermal growth factor receptor) monoclonal antibody cetuximab could be initiated. In the second case, the mutational profile of a patient with initial wild-type RAS-status was continually tracked during the course of treatment. An acquired KRAS exon 3 mutation was detected. The number of KRAS mutated fragments decreased continuously after the discontinuation of the therapy with EGFR-specific antibodies. Conclusion. Liquid biopsy provides a rapid genotype result, which accurately reproduces the current mutation status of tumor tissue. Furthermore, liquid biopsy enables close monitoring of the onset of secondary resistance to anti-EGFR therapy. PMID:28232873

Clinical Application of Liquid Biopsy in Targeted Therapy of Metastatic Colorectal Cancer.

PubMed

Trojan, Jörg; Klein-Scory, Susanne; Koch, Christine; Schmiegel, Wolff; Baraniskin, Alexander

2017-01-01

Background. Colorectal cancers (CRC) shed DNA into blood circulation. There is growing evidence that the analysis of circulating tumor DNA can be effectively used for monitoring of disease, to track tumor heterogeneity and to evaluate response to treatment. Case Presentation. Here, we describe two cases of patients with advanced CRC. The first case is about a patient with no available tissue for analysis of RAS mutation status. Liquid biopsy revealed RAS-wild-type and the therapy with anti-EGFR (epidermal growth factor receptor) monoclonal antibody cetuximab could be initiated. In the second case, the mutational profile of a patient with initial wild-type RAS-status was continually tracked during the course of treatment. An acquired KRAS exon 3 mutation was detected. The number of KRAS mutated fragments decreased continuously after the discontinuation of the therapy with EGFR-specific antibodies. Conclusion . Liquid biopsy provides a rapid genotype result, which accurately reproduces the current mutation status of tumor tissue. Furthermore, liquid biopsy enables close monitoring of the onset of secondary resistance to anti-EGFR therapy.

Acute quadriplegia following closed traction reduction of a cervical facet dislocation in the setting of ossification of the posterior longitudinal ligament: case report.

PubMed

Wimberley, David W; Vaccaro, Alexander R; Goyal, Nitin; Harrop, James S; Anderson, D Greg; Albert, Todd J; Hilibrand, Alan S

2005-08-01

A case report of acute quadriplegia resulting from closed traction reduction of traumatic bilateral cervical facet dislocation in a 54-year-old male with concomitant ossification of the posterior longitudinal ligament (OPLL). To report an unusual presentation of a spinal cord injury, examine the approach to reversal of the injury, and review the treatment and management controversies of acute cervical facet dislocations in specific patient subgroups. The treatment of acute cervical facet dislocations is an area of ongoing controversy, especially regarding the question of the necessity of advanced imaging studies before closed traction reduction of the dislocated cervical spine. The safety of an immediate closed, traction reduction of the cervical spine in awake, alert, cooperative, and appropriately select patients has been reported in several studies. To date, there have been no permanent neurologic deficits resulting from awake, closed reduction reported in the literature. A case of temporary, acute quadriplegia with complete neurologic recovery following successful closed traction reduction of a bilateral cervical facet dislocation in the setting of OPLL is presented. The clinical neurologic examination, radiographic, and advanced imaging studies before and after closed, traction reduction of a cervical facet dislocation are evaluated and discussed. A review of the literature regarding the treatment of acute cervical facet dislocations is presented. Radiographs showed approximately 50% subluxation of the fifth on the sixth cervical vertebrae, along with computerized tomography revealing extensive discontinuous OPLL. The cervical facet dislocation was successfully reduced with an awake, closed traction reduction, before magnetic resonance imaging (MRI) evaluation. The patient subsequently had acute quadriplegia develop, with the ensuing MRI study illustrating severe spinal stenosis at the C5, C6 level as a result of OPLL or a large extruded disc herniation. Following an immediate anterior decompression and a posterior stabilization procedure, the patient regained full motor and sensory function. This case report highlights the advantages and shows some safety concerns regarding immediate, closed traction reduction of cervical facet dislocation with real-time neural monitoring in an awake, alert, oriented, and appropriately select patient before MRI studies in the setting of preexisting central stenosis from OPLL.

Clinical chemistry as scientific discipline: historical perspectives.

PubMed

Büttner, J

1994-12-31

The fundamental ideas which underlie clinical chemistry as an independent scientific field were formed over the course of centuries. Exactly 200 years ago the first modern concepts for this discipline were formulated in close connection with the restructuring of medical education during the French Revolution on the one hand, and the emergence of a new idea of a 'clinic' on the other hand. However, not until 1840 was clinical chemistry institutionalized as academic subject and simultaneously integrated into medical teaching. After about 1860, clinical chemistry was practiced by the clinicians themselves in close relationship with clinical activities, yet again with emphasis on teaching. In this period, clinics and hospitals established 'clinical laboratories'. With the start of the 20th century, after biochemistry had developed into an independent scientific field, clinical chemistry continued to evolve in close relationship with that latter discipline. This was particularly true in the United States, where an 'American School of Clinical Biochemistry' emerged which was to greatly influence the field.

Environmental Surveillance of Norovirus Genogroups I and II for Sensitive Detection of Epidemic Variants

PubMed Central

Miura, Takayuki; Masago, Yoshifumi; Konta, Yoshimitsu; Tohma, Kentaro; Manaka, Takafumi; Liu, Xiaofang; Nakayama, Daisuke; Tanno, Takashi; Saito, Mayuko; Oshitani, Hitoshi; Omura, Tatsuo

2017-01-01

ABSTRACT Sewage samples have been investigated to study the norovirus concentrations in sewage or the genotypes of noroviruses circulating in human populations. However, the statistical relationship between the concentration of the virus and the number of infected individuals and the clinical importance of genotypes or strains detected in sewage are unclear. In this study, we carried out both environmental and clinical surveillance of noroviruses for 3 years, 2013 to 2016. We performed cross-correlation analysis of the concentrations of norovirus GI or GII in sewage samples collected weekly and the reported number of gastroenteritis cases. Norovirus genotypes in sewage were also analyzed by pyrosequencing and compared with those identified in stool samples. The cross-correlation analysis found the peak coefficient (R = 0.51) at a lag of zero, indicating that the variation in the GII concentration, expressed as the log10 number of copies per milliliter, was coincident with that in the gastroenteritis cases. A total of 15 norovirus genotypes and up to 8 genotypes per sample were detected in sewage, which included all of the 13 genotypes identified in the stool samples except 2. GII.4 was most frequently detected in both sample types, followed by GII.17. Phylogenetic analysis revealed that a strain belonging to the GII.17 Kawasaki 2014 lineage had been introduced into the study area in the 2012-2013 season. An increase in GI.3 cases was observed in the 2015-2016 season, and sewage monitoring identified the presence of GI.3 in the previous season (2014-2015). Our results demonstrated that monitoring of noroviruses in sewage is useful for sensitive detection of epidemic variants in human populations. IMPORTANCE We obtained statistical evidence of the relationship between the variation in the norovirus GII concentration in sewage and that of gastroenteritis cases during the 3-year study period. Sewage sample analysis by a pyrosequencing approach enabled us to understand the temporal variation in the norovirus genotypes circulating in human populations. We found that a strain closely related to the GII.17 Kawasaki 2014 lineage had been introduced into the study area at least 1 year before its appearance and identification in clinical cases. A similar pattern was observed for GI.3; cases were reported in the 2015-2016 season, and closely related strains were found in sewage in the previous season. Our observation indicates that monitoring of noroviruses in sewage is useful for the rapid detection of an epidemic and is also sensitive enough to study the molecular epidemiology of noroviruses. Applying this approach to other enteric pathogens in sewage will enhance our understanding of their ecology. PMID:28213546

Microfabricated Multianalyte Sensor Arrays for Metabolic Monitoring

DTIC Science & Technology

2007-09-01

Introduction Intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range can prevent or delay...the occurrence of diabetic related complications.1 Diabetic patients, therefore, have to frequently monitor their blood glucose levels by drawing... blood necessary for conventional glucose monitoring. The blood data obtained gives no indication of direction or trend of blood sugar levels. Even the

Dynamic behaviour of the soft palate during nasal positive pressure ventilation under anaesthesia and paralysis: comparison between patients with and without obstructive sleep-disordered breathing.

PubMed

Okuyama, M; Kato, S; Sato, S; Okazaki, J; Kitamura, Y; Ishikawa, T; Sato, Y; Isono, S

2018-01-01

Difficult mask ventilation is common and is known to be associated with sleep-disordered breathing (SDB). It is our hypothesis that the incidence of expiratory retropalatal (RP) airway closure (primary outcome) during nasal positive pressure ventilation (PPV) is more frequent in patients with SDB (apnea hypopnea index ≥5 h -1 ) than non-SDB subjects. The severity of SDB was assessed before surgery using a portable sleep monitor. In anaesthetized and paralysed patients with (n=11) and without SDB (n=9), we observed the behaviour of the RP airway endoscopically during nasal PPV with the mouth closed and determined the dynamic RP closing pressure, which was defined as the highest airway pressure above which the RP airway closure was reversed. The static RP closing pressure was obtained during cessation of mechanical ventilation in patients with dynamic RP closure during nasal PPV. The expiratory RP airway closure accompanied by expiratory flow limitation occurred more frequently in SDB patients (9/11, 82%) than in non-SDB subjects (2/9, 22%; exact logistic regression analysis: P=0.022, odds ratio 3.6, 95% confidence interval 1.1-15.4). Receiver operating characteristic curve analyses indicated AHI >10h -1 and presence of habitual snoring as clinically useful predictors for the occurrence of RP closure during PPV. Dynamic RP closing pressure was greater than the static RP closing pressure by approximately 4-5 cm H 2 O. Valve-like dynamic RP closure that limits expiratory flow during nasal PPV occurs more frequently in SDB patients. Copyright © 2017. Published by Elsevier Ltd.

Characteristics of claims in the management of septic arthritis in Japan: Retrospective analyses of judicial precedents and closed claims.

PubMed

Otaki, Yasuhiro; DaSilva, Makiko Ishida; Saito, Yuichi; Oyama, Yasuaki; Oiso, Giichiro; Yoshida, Tomohiko; Fukuhara, Masakazu; Moriyama, Mitsuru

2018-03-01

Septic arthritis (SA) cases can result in claims or litigation because of poor prognosis even if it is unavoidable. Although these claims or litigation are useful for understanding causes and background factors of medical errors, the characteristics of malpractice claims associated with SA remain undetermined in Japan. This study aimed to increase our understanding of malpractice claims in the clinical management of SA. We analyzed 6 civil precedents and 16 closed claims of SA from 8530 malpractice claims processed between July 2004 and June 2014 by the Tokyo office of Sompo Japan Nipponkoa Insurance, Incorporated. We also studied 5 accident and 21 incident reports of SA based on project data compiled by the Japan Council for Quality Health Care. The rate of negligence was 83.3% in the precedents and 75.0% in closed claims. Two main malpractice claim patterns were revealed: SA in a lower extremity joint following sepsis caused by methicillin-resistant Staphylococcus aureus in newborns and SA in an injection site following joint injection. These two patterns accounted for 83.3% and 56.3% of judicial cases and closed claim cases, respectively. Breakdowns in care process of accident and incident reports were clearly differentiated from judicial cases or closed claim cases (Fisher's exact test, p < 0.001). It is important to pay particular attention to SA following sepsis in newborns and to monitor for any signs of SA after joint injection to ensure early diagnosis. Analysis of both malpractice claims and accident and incident reports is essential to ensure a full understanding of the situation in Japan. Copyright © 2017. Published by Elsevier Taiwan LLC.

Evaluating the accuracy and large inaccuracy of two continuous glucose monitoring systems.

PubMed

Leelarathna, Lalantha; Nodale, Marianna; Allen, Janet M; Elleri, Daniela; Kumareswaran, Kavita; Haidar, Ahmad; Caldwell, Karen; Wilinska, Malgorzata E; Acerini, Carlo L; Evans, Mark L; Murphy, Helen R; Dunger, David B; Hovorka, Roman

2013-02-01

This study evaluated the accuracy and large inaccuracy of the Freestyle Navigator (FSN) (Abbott Diabetes Care, Alameda, CA) and Dexcom SEVEN PLUS (DSP) (Dexcom, Inc., San Diego, CA) continuous glucose monitoring (CGM) systems during closed-loop studies. Paired CGM and plasma glucose values (7,182 data pairs) were collected, every 15-60 min, from 32 adults (36.2±9.3 years) and 20 adolescents (15.3±1.5 years) with type 1 diabetes who participated in closed-loop studies. Levels 1, 2, and 3 of large sensor error with increasing severity were defined according to absolute relative deviation greater than or equal to ±40%, ±50%, and ±60% at a reference glucose level of ≥6 mmol/L or absolute deviation greater than or equal to ±2.4 mmol/L,±3.0 mmol/L, and ±3.6 mmol/L at a reference glucose level of <6 mmol/L. Median absolute relative deviation was 9.9% for FSN and 12.6% for DSP. Proportions of data points in Zones A and B of Clarke error grid analysis were similar (96.4% for FSN vs. 97.8% for DSP). Large sensor over-reading, which increases risk of insulin over-delivery and hypoglycemia, occurred two- to threefold more frequently with DSP than FSN (once every 2.5, 4.6, and 10.7 days of FSN use vs. 1.2, 2.0, and 3.7 days of DSP use for Level 1-3 errors, respectively). At levels 2 and 3, large sensor errors lasting 1 h or longer were absent with FSN but persisted with DSP. FSN and DSP differ substantially in the frequency and duration of large inaccuracy despite only modest differences in conventional measures of numerical and clinical accuracy. Further evaluations are required to confirm that FSN is more suitable for integration into closed-loop delivery systems.

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.

Sickle cell disease biochip: a functional red blood cell adhesion assay for monitoring sickle cell disease

PubMed Central

ALAPAN, YUNUS; KIM, CEONNE; ADHIKARI, ANIMA; GRAY, KAYLA E.; GURKAN-CAVUSOGLU, EVREN; LITTLE, JANE A.; GURKAN, UMUT A.

2016-01-01

Sickle cell disease (SCD) afflicts millions of people worldwide and is associated with considerable morbidity and mortality. Chronic and acute vaso-occlusion are the clinical hallmarks of SCD and can result in pain crisis, widespread organ damage, and early movtality. Even though the molecular underpinnings of SCD were identified more than 60 years ago, there are no molecular or biophysical markers of disease severity that are feasibly measured in the clinic. Abnormal cellular adhesion to vascular endothelium is at the root of vaso-occlusion. However, cellular adhesion is not currently evaluated clinically. Here, we present a clinically applicable microfluidic device (SCD biochip) that allows serial quantitative evaluation of red blood cell (RBC) adhesion to endothelium-associated protein-immobilized microchannels, in a closed and preprocessing-free system. With the SCD biochip, we have analyzed blood samples from more than 100 subjects and have shown associations between the measured RBC adhesion to endothelium-associated proteins (fibronectin and laminin) and individual RBC characteristics, including hemoglobin content, fetal hemoglobin concentration, plasma lactate dehydrogenase level, and reticulocyte count. The SCD biochip is a functional adhesion assay, reflecting quantitative evaluation of RBC adhesion, which could be used at baseline, during crises, relative to various long-term complications, and before and after therapeutic interventions. PMID:27063958

The regulator's perspective: How should new therapies and follow-on products for MS be clinically evaluated in the future?

PubMed

Crommelin, Daan Ja; Broich, Karl; Holloway, Chris; Meesen, Bianca; Lizrova Preiningerova, Jana; Prugnaud, Jean-Louis; Silva-Lima, Beatriz

2016-08-01

Although there is still no cure for multiple sclerosis (MS), the introduction of several innovative drugs with modes of action different from that of the existing drug arsenal and the progress in monitoring disease progression by imaging and using biomarkers are currently causing a knowledge surge. This provides opportunities for improving patient disease management. New therapies are also under development and pose challenges to the regulatory bodies regarding the optimal design of clinical trials with more patient-focused clinical endpoints. Moreover, with the upcoming patent expiry of some of the key first-line MS treatments in Europe, regulatory bodies will also face the challenge of recommending marketing authorisation for generic and abridged versions based on appropriate requirements for demonstrating equality/similarity to the innovator's product. The goal of this article is to improve the understanding of the relevant guidance documents of the European Medicines Agency (EMA) on clinical investigation of medicinal products and to highlight the issues that the agency will need to clarify regarding follow-on products of first-line MS treatments. Today, it is clear that close collaboration between patients, healthcare professionals, regulatory bodies and industry is crucial for developing new safe and effective drugs, which satisfy the needs of MS patients. © The Author(s), 2016.

Using Smartphones to Monitor Bipolar Disorder Symptoms: A Pilot Study.

PubMed

Beiwinkel, Till; Kindermann, Sally; Maier, Andreas; Kerl, Christopher; Moock, Jörn; Barbian, Guido; Rössler, Wulf

2016-01-06

Relapse prevention in bipolar disorder can be improved by monitoring symptoms in patients' daily life. Smartphone apps are easy-to-use, low-cost tools that can be used to assess this information. To date, few studies have examined the usefulness of smartphone data for monitoring symptoms in bipolar disorder. We present results from a pilot test of a smartphone-based monitoring system, Social Information Monitoring for Patients with Bipolar Affective Disorder (SIMBA), that tracked daily mood, physical activity, and social communication in 13 patients. The objective of this study was to investigate whether smartphone measurements predicted clinical symptoms levels and clinical symptom change. The hypotheses that smartphone measurements are (1) negatively related to clinical depressive symptoms and (2) positively related to clinical manic symptoms were tested. Clinical rating scales were administered to assess clinical depressive and manic symptoms. Patients used a smartphone with the monitoring app for up to 12 months. Random-coefficient multilevel models were computed to analyze the relationship between smartphone data and externally rated manic and depressive symptoms. Overall clinical symptom levels and clinical symptom changes were predicted by separating between-patient and within-patient effects. Using established clinical thresholds from the literature, marginal effect plots displayed clinical relevance of smartphone data. Overall symptom levels and change in clinical symptoms were related to smartphone measures. Higher overall levels of clinical depressive symptoms were predicted by lower self-reported mood measured by the smartphone (beta=-.56, P<.001). An increase in clinical depressive symptoms was predicted by a decline in social communication (ie, outgoing text messages: beta=-.28, P<.001) and a decline in physical activity as measured by the smartphone (ie, cell tower movements: beta=-.11, P=.03). Higher overall levels of clinical manic symptoms were predicted by lower physical activity on the smartphone (ie, distance travelled: beta=-.37, P<.001), and higher social communication (beta=.48, P=.03). An increase in clinical manic symptoms was predicted by a decrease in physical activity on the smartphone (beta=-.17, P<.001). Clinical symptoms were related to some objective and subjective smartphone measurements, but not all smartphone measures predicted the occurrence of bipolar symptoms above clinical thresholds. Thus, smartphones have the potential to monitor bipolar disorder symptoms in patients' daily life. Further validation of monitoring tools in a larger sample is needed. Conclusions are limited by the low prevalence of manic and depressive symptoms in the study sample. International Standard Randomized Controlled Trial Number (ISRCTN): 05663421; http://www.controlled-trials.com/ISRCTN05663421 (Archived by WebCite at http://www.webcitation.org/6d9wsibJB).

Pain relief is associated with decreasing postural sway in patients with non-specific low back pain.

PubMed

Ruhe, Alexander; Fejer, René; Walker, Bruce

2012-03-21

Increased postural sway is well documented in patients suffering from non-specific low back pain, whereby a linear relationship between higher pain intensities and increasing postural sway has been described. No investigation has been conducted to evaluate whether this relationship is maintained if pain levels change in adults with non-specific low back pain. Thirty-eight patients with non-specific low back pain and a matching number of healthy controls were enrolled. Postural sway was measured by three identical static bipedal standing tasks of 90 sec duration with eyes closed in narrow stance on a firm surface. The perceived pain intensity was assessed by a numeric rating scale (NRS-11). The patients received three manual interventions (e.g. manipulation, mobilization or soft tissue techniques) at 3-4 day intervals, postural sway measures were obtained at each occasion. A clinically relevant decrease of four NRS scores in associated with manual interventions correlated with a significant decrease in postural sway. In contrast, if no clinically relevant change in intensity occurred (≤ 1 level), postural sway remained similar compared to baseline. The postural sway measures obtained at follow-up sessions 2 and 3 associated with specific NRS level showed no significant differences compared to reference values for the same pain score. Alterations in self-reported pain intensities are closely related to changes in postural sway. The previously reported linear relationship between the two variables is maintained as pain levels change. Pain interference appears responsible for the altered sway in pain sufferers. This underlines the clinical use of sway measures as an objective monitoring tool during treatment or rehabilitation.

Automated manufacturing of chimeric antigen receptor T cells for adoptive immunotherapy using CliniMACS prodigy.

PubMed

Mock, Ulrike; Nickolay, Lauren; Philip, Brian; Cheung, Gordon Weng-Kit; Zhan, Hong; Johnston, Ian C D; Kaiser, Andrew D; Peggs, Karl; Pule, Martin; Thrasher, Adrian J; Qasim, Waseem

2016-08-01

Novel cell therapies derived from human T lymphocytes are exhibiting enormous potential in early-phase clinical trials in patients with hematologic malignancies. Ex vivo modification of T cells is currently limited to a small number of centers with the required infrastructure and expertise. The process requires isolation, activation, transduction, expansion and cryopreservation steps. To simplify procedures and widen applicability for clinical therapies, automation of these procedures is being developed. The CliniMACS Prodigy (Miltenyi Biotec) has recently been adapted for lentiviral transduction of T cells and here we analyse the feasibility of a clinically compliant T-cell engineering process for the manufacture of T cells encoding chimeric antigen receptors (CAR) for CD19 (CAR19), a widely targeted antigen in B-cell malignancies. Using a closed, single-use tubing set we processed mononuclear cells from fresh or frozen leukapheresis harvests collected from healthy volunteer donors. Cells were phenotyped and subjected to automated processing and activation using TransAct, a polymeric nanomatrix activation reagent incorporating CD3/CD28-specific antibodies. Cells were then transduced and expanded in the CentriCult-Unit of the tubing set, under stabilized culture conditions with automated feeding and media exchange. The process was continuously monitored to determine kinetics of expansion, transduction efficiency and phenotype of the engineered cells in comparison with small-scale transductions run in parallel. We found that transduction efficiencies, phenotype and function of CAR19 T cells were comparable with existing procedures and overall T-cell yields sufficient for anticipated therapeutic dosing. The automation of closed-system T-cell engineering should improve dissemination of emerging immunotherapies and greatly widen applicability. Copyright © 2016. Published by Elsevier Inc.

Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study.

PubMed

Brosteanu, Oana; Schwarz, Gabriele; Houben, Peggy; Paulus, Ursula; Strenge-Hesse, Anke; Zettelmeyer, Ulrike; Schneider, Anja; Hasenclever, Dirk

2017-12-01

Background According to Good Clinical Practice, clinical trials must protect rights and safety of patients and make sure that the trial results are valid and interpretable. Monitoring on-site has an important role in achieving these objectives; it controls trial conduct at trial sites and informs the sponsor on systematic problems. In the past, extensive on-site monitoring with a particular focus on formal source data verification often lost sight of systematic problems in study procedures that endanger Good Clinical Practice objectives. ADAMON is a prospective, stratified, cluster-randomised, controlled study comparing extensive on-site monitoring with risk-adapted monitoring according to a previously published approach. Methods In all, 213 sites from 11 academic trials were cluster-randomised between extensive on-site monitoring (104) and risk-adapted monitoring (109). Independent post-trial audits using structured manuals were performed to determine the frequency of major Good Clinical Practice findings at the patient level. The primary outcome measure is the proportion of audited patients with at least one major audit finding. Analysis relies on logistic regression incorporating trial and monitoring arm as fixed effects and site as random effect. The hypothesis was that risk-adapted monitoring is non-inferior to extensive on-site monitoring with a non-inferiority margin of 0.60 (logit scale). Results Average number of monitoring visits and time spent on-site was 2.1 and 2.7 times higher in extensive on-site monitoring than in risk-adapted monitoring, respectively. A total of 156 (extensive on-site monitoring: 76; risk-adapted monitoring: 80) sites were audited. In 996 of 1618 audited patients, a total of 2456 major audit findings were documented. Depending on the trial, findings were identified in 18%-99% of the audited patients, with no marked monitoring effect in any of the trials. The estimated monitoring effect is -0.04 on the logit scale with two-sided 95% confidence interval (-0.40; 0.33), demonstrating that risk-adapted monitoring is non-inferior to extensive on-site monitoring. At most, extensive on-site monitoring could reduce the frequency of major Good Clinical Practice findings by 8.2% compared with risk-adapted monitoring. Conclusion Compared with risk-adapted monitoring, the potential benefit of extensive on-site monitoring is small relative to overall finding rates, although risk-adapted monitoring requires less than 50% of extensive on-site monitoring resources. Clusters of findings within trials suggest that complicated, overly specific or not properly justified protocol requirements contributed to the overall frequency of findings. Risk-adapted monitoring in only a sample of patients appears sufficient to identify systematic problems in the conduct of clinical trials. Risk-adapted monitoring has a part to play in quality control. However, no monitoring strategy can remedy defects in quality of design. Monitoring should be embedded in a comprehensive quality management approach covering the entire trial lifecycle.

Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study

PubMed Central

Brosteanu, Oana; Schwarz, Gabriele; Houben, Peggy; Paulus, Ursula; Strenge-Hesse, Anke; Zettelmeyer, Ulrike; Schneider, Anja; Hasenclever, Dirk

2017-01-01

Background According to Good Clinical Practice, clinical trials must protect rights and safety of patients and make sure that the trial results are valid and interpretable. Monitoring on-site has an important role in achieving these objectives; it controls trial conduct at trial sites and informs the sponsor on systematic problems. In the past, extensive on-site monitoring with a particular focus on formal source data verification often lost sight of systematic problems in study procedures that endanger Good Clinical Practice objectives. ADAMON is a prospective, stratified, cluster-randomised, controlled study comparing extensive on-site monitoring with risk-adapted monitoring according to a previously published approach. Methods In all, 213 sites from 11 academic trials were cluster-randomised between extensive on-site monitoring (104) and risk-adapted monitoring (109). Independent post-trial audits using structured manuals were performed to determine the frequency of major Good Clinical Practice findings at the patient level. The primary outcome measure is the proportion of audited patients with at least one major audit finding. Analysis relies on logistic regression incorporating trial and monitoring arm as fixed effects and site as random effect. The hypothesis was that risk-adapted monitoring is non-inferior to extensive on-site monitoring with a non-inferiority margin of 0.60 (logit scale). Results Average number of monitoring visits and time spent on-site was 2.1 and 2.7 times higher in extensive on-site monitoring than in risk-adapted monitoring, respectively. A total of 156 (extensive on-site monitoring: 76; risk-adapted monitoring: 80) sites were audited. In 996 of 1618 audited patients, a total of 2456 major audit findings were documented. Depending on the trial, findings were identified in 18%–99% of the audited patients, with no marked monitoring effect in any of the trials. The estimated monitoring effect is −0.04 on the logit scale with two-sided 95% confidence interval (−0.40; 0.33), demonstrating that risk-adapted monitoring is non-inferior to extensive on-site monitoring. At most, extensive on-site monitoring could reduce the frequency of major Good Clinical Practice findings by 8.2% compared with risk-adapted monitoring. Conclusion Compared with risk-adapted monitoring, the potential benefit of extensive on-site monitoring is small relative to overall finding rates, although risk-adapted monitoring requires less than 50% of extensive on-site monitoring resources. Clusters of findings within trials suggest that complicated, overly specific or not properly justified protocol requirements contributed to the overall frequency of findings. Risk-adapted monitoring in only a sample of patients appears sufficient to identify systematic problems in the conduct of clinical trials. Risk-adapted monitoring has a part to play in quality control. However, no monitoring strategy can remedy defects in quality of design. Monitoring should be embedded in a comprehensive quality management approach covering the entire trial lifecycle. PMID:28786330

Computer-controlled closed-loop drug infusion system for automated hemodynamic resuscitation in endotoxin-induced shock.

PubMed

Uemura, Kazunori; Kawada, Toru; Zheng, Can; Li, Meihua; Sugimachi, Masaru

2017-10-23

Hemodynamic resuscitation in septic shock requires aggressive fluid replacement and appropriate use of vasopressors to optimize arterial pressure (AP) and cardiac output (CO). Because responses to these drugs vary between patients and within patient over time, strict monitoring of patient condition and repetitive adjustment of drug dose are required. This task is time and labor consuming, and is associated with poor adherence to resuscitation guidelines. To overcome this issue, we developed a computer-controlled closed-loop drug infusion system for automated hemodynamic resuscitation in septic shock, and evaluated the performance of the system in a canine model of endotoxin shock. Our system monitors AP, CO and central venous pressure, and computes arterial resistance (R), stressed blood volume (V) and Frank-Starling slope of left ventricle (S). The system controls R with noradrenaline (NA), and V with Ringer's acetate solution (RiA), thereby controlling AP and CO. In 4 dogs, AP and CO were measured invasively. In another 4 dogs, AP and CO were measured less invasively using clinically acceptable modalities, aiming to make the system clinically feasible. In all 8 dogs, endotoxin shock was induced by injecting Escherichia coli lipopolysaccharide, which significantly decreased AP from 95 (91-108) to 43 (39-45) mmHg, and CO from 112 (104-142) to 62 (51-73) ml·min -1 ·kg -1 . The system was then connected to the dogs, and activated. System performance was observed over a period of 4 h. Our system immediately started infusions of NA and RiA. Within 40 min, RiA increased V to target level, and NA maintained R at target level, while S was concomitantly increased. These resulted in restoration of AP to 70 (69-71) mmHg and CO to 130 (125-138) ml·min -1 ·kg -1 . Median of absolute performance error, an index of precision of control, was small in AP [2.5 (2.1-4.5) %] and CO [2.4 (1.4-5.5) %], which were not increased even when the variables were measured less invasively. In a canine model of endotoxin shock, our system automatically improved and maintained AP and CO at their target values with small performance error. Our system is potentially an attractive clinical tool for rescuing patients with septic shock.

Low-cost measurement and monitoring system for cryogenic applications

NASA Astrophysics Data System (ADS)

Tubío Araújo, Óscar; Hernández Suárez, Elvio; Gracia Temich, Félix

2016-07-01

Cryostats are closed chambers that hinder the monitoring of materials, structures or systems installed therein. This paper presents a webcam-based measurement and monitoring system, which can operate under vacuum and cryogenic conditions to be mainly used in astrophysical applications. The system can be configured in two different assemblies: wide field that can be used for mechanism monitoring and narrow field, especially useful in cryogenic precision measurements with a resolution up to 4 microns/pixel.

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

[Clinical evaluation of open and close treatment in pediatric condylar fractures].

PubMed

Han, Jing; Li, Zhi; Zhou, Haihua; Yang, Rongtao; Xiong, Guizhong; Li, Zubing

2014-08-01

To evaluate the long-term clinical and radiographic outcomes of open and close treatment of condylar fractures of mandible in children. A total of 78 cases (105 mandibular condylar fractures) were included in this study. All patients (younger than 12 years at the time of injury were followed up for at least 3 years. According to the classification of the condylar fractures, open or close treatment was chosen. Clinical outcomes were classified as favorable or unfavorable depending on the mouth opening, pattern of mouth opening, occlusion, facial symmetry. Condylar remodeling was defined as complete, moderate, or poor based on the radiographic findings. Depending on the classification, 14 sides of type I, 48 sides of type II and 43 sides of type III were included in this study. Open treatment was chosen in 51 sides and close treatment was chosen in 54 sides. Most of the patients acquired satisfactory clinical outcomes. Better radiologic remodeling of the condylar process was found in the patients treated by open treatment. Favorable long-term clinical outcomes were obtained in both open and close treatment of mandibular condylar fractures. A better morphological remodeling of condylar process was found in patients with open treatment.

The Clinical, Serological and Molecular Diagnosis of Emerging Dengue Infection at a Tertiary Care Institute in Southern, India

PubMed Central

Neeraja, Mamidi; Lakshmi, Vemu; Dash, P.K.; Parida, M.M.; Rao, P.V.L.

2013-01-01

Introduction: Dengue is an acute viral infection which presents as uneventful pyrexia to a fatal complication. This infection is increasingly being recognized as the world’s major emerging tropical disease and an important public health problem. This article highlights the clinical manifestations of Dengue virus infection and the various molecular tests that were used for its laboratory diagnosis. Methods: Serum samples from 713 suspected cases of Dengue were collected between August and December 2007. The clinical profiles of 123 hospitalized patients were analyzed. Serology, RT- PCR, virus isolation and sequencing were done. Results: The most common clinical symptoms were fever, thrombocytopenia, rash and elevated liver enzymes. The demonstration of the Dengue RNA in 5.16% samples, the detection of Dengue specific IgM antibodies in 18% samples and the isolation of the DENV-4 and the DENV-3 viruses from the clinical samples confirmed this Dengue outbreak. A co -infection with Chikungunya was observed in 2.06% of the cases. The phylogenetic analysis revealed that the Indian Dengue-4 isolates from this outbreak belonged to the genotype I. This study clearly indicated the sudden dominance of DENV-4 in an Indian Dengue outbreak. Conclusion: The surveillance of the Dengue viruses needs to be closely monitored for the emergence of newer serotype(s) in hitherto unknown areas. PMID:23634396

Vaginal douching and associated factors among married women attending a family planning clinic or a gynecology clinic.

PubMed

Caliskan, Deniz; Subasi, Nuket; Sarisen, Ozlem

2006-08-01

The aim of this study was to determine the vaginal douching habits and associated factors of women attending two different healthcare clinics. This cross-sectional study was conducted between 1 and 31 May 2004. All participants were women (n=635) who attended either a university hospital gynecology clinic or a primary health care center family planning unit. One-way ANOVA, chi-squared test, and binary and multiple logistic regression analyses were used for the statistical evaluation of data. The mean age of the participants was 36.90+/-10.72 years (range: 18-75). Half of the participants believed vaginal douching had a positive effect on health. They believed vaginal douching demonstrates cleanliness, prevents infections and pregnancy, removes sperm following intercourse, a necessity of Islamic doctrine, and reduces symptoms like discharge, unpleasant odor, etc. Of the women, 50.2% performed vaginal douching. Vaginal douching was associated with age, education level, type of dwelling, working outside of the home, age at marriage, age at birth of first child, parity, spontaneous abortion, history of pelvic inflammatory disease, use of contraceptives, and attending a healthcare clinic. Douching is a common habit among Turkish women. Many women are not aware of the harmful effects of douching. Public health and health professionals should monitor more closely this traditional habit in Turkey.

Home monitoring of patients with Parkinson's disease via wearable technology and a web-based application.

PubMed

Patel, Shyamal; Chen, Bor-Rong; Buckley, Thomas; Rednic, Ramona; McClure, Doug; Tarsy, Daniel; Shih, Ludy; Dy, Jennifer; Welsh, Matt; Bonato, Paolo

2010-01-01

Objective long-term health monitoring can improve the clinical management of several medical conditions ranging from cardiopulmonary diseases to motor disorders. In this paper, we present our work toward the development of a home-monitoring system. The system is currently used to monitor patients with Parkinson's disease who experience severe motor fluctuations. Monitoring is achieved using wireless wearable sensors whose data are relayed to a remote clinical site via a web-based application. The work herein presented shows that wearable sensors combined with a web-based application provide reliable quantitative information that can be used for clinical decision making.

Chapter 3 innovations in the en route care of combat casualties.

PubMed

Hatzfeld, Jennifer J; Dukes, Susan; Bridges, Elizabeth

2014-01-01

The en route care environment is dynamic and requires constant innovation to ensure appropriate nursing care for combat casualties. Building on experiences in Iraq and Afghanistan, there have been tremendous innovations in the process of transporting patients, including the movement of patients with spinal injuries. Advances have also been made in pain management and noninvasive monitoring, particularly for trauma and surgical patients requiring close monitoring of their hemodynamic and perfusion status. In addition to institutionalizing these innovations, future efforts are needed to eliminate secondary insults to patients with traumatic brain injuries and technologies to provide closed-loop sedation and ventilation.

Long-term reproducibility of phantom signal intensities in nonuniformity corrected STIR-MRI examinations of skeletal muscle.

PubMed

Viddeleer, Alain R; Sijens, Paul E; van Ooijen, Peter M A; Kuypers, Paul D L; Hovius, Steven E R; Oudkerk, Matthijs

2009-08-01

Nerve regeneration could be monitored by comparing MRI image intensities in time, as denervated muscles display increased signal intensity in STIR sequences. In this study long-term reproducibility of STIR image intensity was assessed under clinical conditions and the required image intensity nonuniformity correction was improved by using phantom scans obtained at multiple positions. Three-dimensional image intensity nonuniformity was investigated in phantom scans. Next, over a three-year period, 190 clinical STIR hand scans were obtained using a standardized acquisition protocol, and corrected for intensity nonuniformity by using the results of phantom scanning. The results of correction with 1, 3, and 11 phantom scans were compared. The image intensities in calibration tubes close to the hands were measured every time to determine the reproducibility of our method. With calibration, the reproducibility of STIR image intensity improved from 7.8 to 6.4%. Image intensity nonuniformity correction with 11 phantom scans gave significantly better results than correction with 1 or 3 scans. The image intensities in clinical STIR images acquired at different times can be compared directly, provided that the acquisition protocol is standardized and that nonuniformity correction is applied. Nonuniformity correction is preferably based on multiple phantom scans.

Automated in-clinic hematology instruments for small animal practitioners: what is available, what can they really do, and how do i make a choice?

PubMed

Welles, Elizabeth G

2012-01-01

To have an in-clinic hematology instrument in your practice and how it is used are decisions that precede the purchase of an instrument. Advantages and limitations of the various instruments should be considered. Initial purchase cost, reagent/disposable costs, costs of training personnel in the use and care of the instrument, and service/repair contract costs need to be considered. Once the decision is made to have an in-office hematology instrument in your practice you should benefit from having nearly immediate CBC data results that enable you to provide better quality medicine, more rapid clinical decisions, more closely monitor patients for complications of disease or response to treatment. It should also generate revenue and allow some of your staff members to expand and develop their technical skills as they learn the nuances of a new diagnostic tool and how to provide you with the most accurate CBC information. In the final assessment, the addition of an in-office hematology instrument should improve the quality and efficiency of the medical care you provide patients and generate additional practice income.

[Individualized restorative designs and clinical evaluation for dental implants in the anterior esthetic zone with inappropriate conditions].

PubMed

Dai, Wen-yong; Zhou, Guo-xing; Zhang, Xiao-zhen; Zhao, Yi; Wang, Jie; Yang, Yi; Zhu, Zhi-jun; Tang, Chun-bo

2014-08-01

To offer individualized restorative strategies for patients receiving dental implants in the anterior esthetic zone but with inappropriate available conditions and evaluate the clinical outcomes. Forty-six patients with 58 implants were recruited for the study in accordance with the criteria and received individualized implant prostheses in the anterior esthetic zone. The patients were followed up for 3-24 months, and the clinical outcomes were evaluated by pink and white esthetic scores (PES/WES). The patients were from 18 to 69 years old, and followed up for 12.6 months in average. According to the third month follow-up esthetic scores, for PES, 1.72% of the patients got low scores, 44.83% got medium scores and 53.45% got high scores; For WES, 0% got low scores, 20.69% got medium scores and 79.31% got high scores. No implant failure or peri-implantitis occurred. Individualized restorative designs for implants in the esthetic zone can effectively improve the appearance of the prostheses which originally have no appropriate available space. Close follow-up and monitoring of the peri-implant soft tissue and proper oral hygiene instructions are important to ensure the conditions of the prostheses.

The procedure of new drug application and the philosophy of critical rationalism or the limits of quality assurance with good clinical practice.

PubMed

Högel, J; Gaus, W

1999-12-01

K.R. Popper's philosophy of critical rationalism is concerned with the detection and removal of error. Fundamental contradictions exist between Popper's theory of knowledge and the present-day practice of the clinical investigation of new drugs. Currently, the public authorities concerned with the licensing of drugs pass judgment on trials, which are closely linked by the one-sponsor problem: the assertions made by the sponsor are not independently confirmed. This lack leads to excessive documentation and to costly monitoring and auditing, which are intended to ensure the credibility of results. In Popper's view, confirmatory trials, independent of the sponsor and supervised by the regulatory bodies, would be a better way to achieve reliable knowledge. The consequence would, among other things, be a reorganization of phase III of the clinical investigation of new drugs by dividing it into independent parts, one under the control of the sponsor and one under the control of the public authority. The implementation of this suggestion would lead to a more scientific manner of dealing with new drugs and to savings in terms of unproductive measures during the application process.

Clinical services provided by staff pharmacists in a community hospital.

PubMed

Garrelts, J C; Smith, D F

1990-09-01

A program for developing staff pharmacists' clinical skills and documenting pharmacists' clinical interventions in a large community teaching hospital is described. A coordinator hired in 1984 to develop clinical pharmacy services began a didactic and experiential program for baccalaureate-level staff pharmacists. Fourteen educational modules are supplemented by journal and textbook articles and small-group discussions of clinical cases, and the clinical coordinator provides individual training on the patient-care units for each pharmacist. Monitoring of clinical pharmacy services began in June 1987; each intervention provided by a pharmacist is recorded on a specially designed form. A target-drug program is used to document cost avoidance achieved through clinical services. Information collected through these monitoring activities is used to educate the pharmacy staff, shared with the pharmacy and therapeutics committee, and used to monitor prescribing patterns of individual physicians. The data are used in the hospital's productivity-monitoring system. All pharmacists who were on staff in 1984 have completed the educational modules, and all new employees are in the process. Since monitoring began, the number of clinical interventions has averaged 2098 per month. Cost avoidance has averaged $9306 per month. Over a five-year period, the development of staff pharmacists' clinical services raised the level of professional practice, produced substantial cost avoidance, and increased the number of pharmacist interventions in medication use.

A protocol for a prospective observational study using chest and thumb ECG: transient ECG assessment in stroke evaluation (TEASE) in Sweden.

PubMed

Magnusson, Peter; Koyi, Hirsh; Mattsson, Gustav

2018-04-03

Atrial fibrillation (AF) causes ischaemic stroke and based on risk factor evaluation warrants anticoagulation therapy. In stroke survivors, AF is typically detected with short-term ECG monitoring in the stroke unit. Prolonged continuous ECG monitoring requires substantial resources while insertable cardiac monitors are invasive and costly. Chest and thumb ECG could provide an alternative for AF detection poststroke.The primary objective of our study is to assess the incidence of newly diagnosed AF during 28 days of chest and thumb ECG monitoring in cryptogenic stroke. Secondary objectives are to assess health-related quality of life (HRQoL) using short-form health survey (SF-36) and the feasibility of the Coala Heart Monitor in patients who had a stroke. Stroke survivors in Region Gävleborg, Sweden, will be eligible for the study from October 2017. Patients with a history of ischaemic stroke without documented AF before or during ECG evaluation in the stroke unit will be evaluated by the chest and thumb ECG system Coala Heart Monitor. The monitoring system is connected to a smartphone application which allows for remote monitoring and prompt advice on clinical management. Over a period of 28 days, patients will be monitored two times a day and may activate the ECG recording at symptoms. On completion, the system is returned by mail. This system offers a possibility to evaluate the presence of AF poststroke, but the feasibility of this system in patients who recently suffered from a stroke is unknown. In addition, HRQoL using SF-36 in comparison to Swedish population norms will be assessed. The feasibility of the Coala Heart Monitor will be assessed by a self-developed questionnaire. The study was approved by The Regional Ethical Committee in Uppsala (2017/321). The database will be closed after the last follow-up, followed by statistical analyses, interpretation of results and dissemination to a scientific journal. NCT03301662; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A systematic review of approaches to refeeding in patients with anorexia nervosa.

PubMed

Garber, Andrea K; Sawyer, Susan M; Golden, Neville H; Guarda, Angela S; Katzman, Debra K; Kohn, Michael R; Le Grange, Daniel; Madden, Sloane; Whitelaw, Melissa; Redgrave, Graham W

2016-03-01

Given the importance of weight restoration for recovery in patients with anorexia nervosa (AN), we examined approaches to refeeding in adolescents and adults across treatment settings. Systematic review of PubMed, PsycINFO, Scopus, and Clinical Trials databases (1960-2015) using terms refeeding, weight restoration, hypophosphatemia, anorexia nervosa, anorexia, and anorexic. Of 948 screened abstracts, 27 met these inclusion criteria: participants had AN; reproducible refeeding approach; weight gain, hypophosphatemia or cognitive/behavioral outcomes. Twenty-six studies (96%) were observational/prospective or retrospective and performed in hospital. Twelve studies published since 2010 examined approaches starting with higher calories than currently recommended (≥1400 kcal/d). The evidence supports 8 conclusions: 1) In mildly and moderately malnourished patients, lower calorie refeeding is too conservative; 2) Both meal-based approaches or combined nasogastric+meals can administer higher calories; 3) Higher calorie refeeding has not been associated with increased risk for the refeeding syndrome under close medical monitoring with electrolyte correction; 4) In severely malnourished inpatients, there is insufficient evidence to change the current standard of care; 5) Parenteral nutrition is not recommended; 6) Nutrient compositions within recommended ranges are appropriate; 7) More research is needed in non-hospital settings; 8) The long-term impact of different approaches is unknown; Findings support higher calorie approaches to refeeding in mildly and moderately malnourished patients under close medical monitoring, however the safety, long-term outcomes, and feasibility outside of hospital have not been established. Further research is also needed on refeeding approaches in severely malnourished patients, methods of delivery, nutrient compositions and treatment settings. © 2015 Wiley Periodicals, Inc.

7 CFR 550.26 - Monitoring program performance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the cooperator, audit reports, site visits, and other... administratively closed out and no longer providing active support in order to resolve issues of accountability and...

7 CFR 550.26 - Monitoring program performance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the cooperator, audit reports, site visits, and other... administratively closed out and no longer providing active support in order to resolve issues of accountability and...

7 CFR 550.26 - Monitoring program performance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the cooperator, audit reports, site visits, and other... administratively closed out and no longer providing active support in order to resolve issues of accountability and...

7 CFR 550.26 - Monitoring program performance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the cooperator, audit reports, site visits, and other... administratively closed out and no longer providing active support in order to resolve issues of accountability and...

A Low-Cost, In Situ Resistivity and Temperature Monitoring System

EPA Science Inventory

We present a low-cost, reliable method for long-term in situ autonomous monitoring of subsurface resistivity and temperature in a shallow, moderately heterogeneous subsurface. Probes, to be left in situ, were constructed at relatively low cost with close electrode spacing. Once i...

Monitoring means for combustion engine electric storage battery means

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

Miller, G. K.; Rautiola, R. E.; Taylor, R. E.

Disclosed, in combination, are a combustion engine, an electric storage battery, an electrically powered starter motor for at times driving the engine in order to start the engine, and an electrical system monitor; the electrical system monitor has a first monitoring portion which senses the actual voltage across the battery and a second monitoring portion which monitors the current through the battery; an electrical switch controls associated circuitry and is actuatable into open or closed conditions; whenever the first monitoring portion senses a preselected magnitude of the actual voltage across the battery or the second monitoring portion senses a preselectedmore » magnitude of the current flow through the battery, the electrical switch is actuated.« less

A review of implantable biosensors for closed-loop glucose control and other drug delivery applications.

PubMed

Scholten, Kee; Meng, Ellis

2018-06-15

Closed-loop drug delivery promises autonomous control of pharmacotherapy through the continuous monitoring of biomarker levels. For decades, researchers have strived for portable closed-loop systems capable of treating ambulatory patients with chronic conditions such as diabetes mellitus. After years of development, the first of these systems have left the laboratory and entered commercial use. This long-awaited advance reflects recent development of chronically stable implantable biosensors able to accurately measure biomarker levels in vivo. This review discusses the role of implantable biosensors in closed-loop drug delivery applications, with the intent to provide a resource for engineers and researchers studying such systems. We provide an overview of common biosensor designs and review the principle challenges in implementing long indwelling sensors: namely device sensitivity, selectivity, and lifetime. This review examines novel advances in transducer design, biological interface, and material biocompatibility, with a focus on recent academic and commercial work which provide successful strategies to overcome perennial challenges. This review focuses primarily on the topics of closed-loop glucose control and continuous glucose monitoring biosensors, which make up the overwhelming majority of published research in this area. We conclude with an overview of recent advances in closed-loop systems targeting applications outside blood glucose management. Copyright © 2018 Elsevier B.V. All rights reserved.

Monitoring Trends in Educational Growth: A Partnership Service to Monitor the Educational Growth of Students in the Early to Middle Years of Schooling

ERIC Educational Resources Information Center

Australian Council for Educational Research, 2015

2015-01-01

Monitoring Trends in Educational Growth (MTEG) offers a flexible, collaborative approach to developing and implementing an assessment of learning outcomes that yields high-quality, nationally relevant data. MTEG is a service that involves ACER staff working closely with each country to develop an assessment program that meets the country's…

Clinical, hemispheric, and autonomic changes associated with use of closed-loop, allostatic neurotechnology by a case series of individuals with self-reported symptoms of post-traumatic stress.

PubMed

Tegeler, Charles H; Cook, Jared F; Tegeler, Catherine L; Hirsch, Joshua R; Shaltout, Hossam A; Simpson, Sean L; Fidali, Brian C; Gerdes, Lee; Lee, Sung W

2017-04-19

The objective of this pilot study was to explore the use of a closed-loop, allostatic, acoustic stimulation neurotechnology for individuals with self-reported symptoms of post-traumatic stress, as a potential means to impact symptomatology, temporal lobe high frequency asymmetry, heart rate variability (HRV), and baroreflex sensitivity (BRS). From a cohort of individuals participating in a naturalistic study to evaluate use of allostatic neurotechnology for diverse clinical conditions, a subset was identified who reported high scores on the Posttraumatic Stress Disorder Checklist (PCL). The intervention entailed a series of sessions wherein brain electrical activity was monitored noninvasively at high spectral resolutions, with software algorithms translating selected brain frequencies into acoustic stimuli (audible tones) that were delivered back to the user in real time, to support auto-calibration of neural oscillations. Participants completed symptom inventories before and after the intervention, and a subset underwent short-term blood pressure recordings for HRV and BRS. Changes in temporal lobe high frequency asymmetry were analyzed from baseline assessment through the first four sessions, and for the last four sessions. Nineteen individuals (mean age 47, 11 women) were enrolled, and the majority also reported symptom scores that exceeded inventory thresholds for depression. They undertook a median of 16 sessions over 16.5 days, and 18 completed the number of sessions recommended. After the intervention, 89% of the completers reported clinically significant decreases in post-traumatic stress symptoms, indicated by a change of at least 10 points on the PCL. At a group level, individuals with either rightward (n = 7) or leftward (n = 7) dominant baseline asymmetry in temporal lobe high frequency (23-36 Hz) activity demonstrated statistically significant reductions in their asymmetry scores over the course of their first four sessions. For 12 individuals who underwent short-term blood pressure recordings, there were statistically significant increases in HRV in the time domain and BRS (Sequence Up). There were no adverse events. Closed-loop, allostatic neurotechnology for auto-calibration of neural oscillations appears promising as an innovative therapeutic strategy for individuals with symptoms of post-traumatic stress. ClinicalTrials.gov #NCT02709369 , retrospectively registered on March 4, 2016.

Can validated wrist devices with position sensors replace arm devices for self-home blood pressure monitoring? A randomized crossover trial using ambulatory monitoring as reference.

PubMed

Stergiou, George S; Christodoulakis, George R; Nasothimiou, Efthimia G; Giovas, Periklis P; Kalogeropoulos, Petros G

2008-07-01

Electronic devices that measure blood pressure (BP) at the arm level are regarded as more accurate than wrist devices and are preferred for home BP (HBP) monitoring. Recently, wrist devices with position sensors have been successfully validated using established protocols. This study assessed whether HBP values measured with validated wrist devices are sufficiently reliable to be used for making patient-related decisions in clinical practice. This randomized crossover study compared HBP measurements taken using validated wrist devices (wrist-HBP, Omron R7 with position sensor) with those taken using arm devices (arm-HBP, Omron 705IT), and also with measurements of awake ambulatory BP (ABP, SpaceLabs), in 79 subjects (36 men and 43 women) with hypertension. The mean age of the study population was 56.7 +/- 11.8 years, and 33 of the subjects were not under treatment for hypertension. The average arm-HBP was higher than the average wrist-HBP (mean difference, systolic 5.2 +/- 9.1 mm Hg, P < 0.001, and diastolic 2.2 +/- 6.7, P < 0.01). Twenty-seven subjects (34%) had a > or =10 mm Hg difference between systolic wrist-HBP and arm-HBP and twelve subjects (15%) showed similar levels of disparity in diastolic HBP readings. Strong correlations were found between arm-HBP and wrist-HBP (r 0.74/0.74, systolic/diastolic, P < 0.0001). However, ABP was more strongly correlated with arm-HBP (r 0.73/0.76) than with wrist-HBP (0.55/0.69). The wrist-arm HBP difference was associated with systolic ABP (r 0.34) and pulse pressure (r 0.29), but not with diastolic ABP, sex, age, arm circumference, and wrist circumference. There might be important differences in HBP measured using validated wrist devices with position sensor vs. arm devices, and these could impact decisions relating to the patient in clinical practice. Measurements taken using arm devices are more closely related to ABP values than those recorded by wrist devices. More research is needed before recommending the widespread use of wrist monitors in clinical practice. American Journal of Hypertension doi:10.1038/ajh.2008.176American Journal of Hypertension (2008); 21, 7, 753-758. doi:10.1038/ajh.2008.176.

Blood pressure self-monitoring in pregnancy: examining feasibility in a prospective cohort study.

PubMed

Tucker, Katherine L; Taylor, Kathryn S; Crawford, Carole; Hodgkinson, James A; Bankhead, Clare; Carver, Tricia; Ewers, Elizabeth; Glogowska, Margaret; Greenfield, Sheila M; Ingram, Lucy; Hinton, Lisa; Khan, Khalid S; Locock, Louise; Mackillop, Lucy; McCourt, Christine; Pirie, Alexander M; Stevens, Richard; McManus, Richard J

2017-12-28

Raised blood pressure (BP) affects approximately 10% of pregnancies worldwide, and a high proportion of affected women develop pre-eclampsia. This study aimed to evaluate the feasibility of self-monitoring of BP in pregnancy in women at higher risk of pre-eclampsia. This prospective cohort study of self-monitoring BP in pregnancy was carried out in two hospital trusts in Birmingham and Oxford and thirteen primary care practices in Oxfordshire. Eligible women were those defined by the UK National Institute for Health and Care Excellence (NICE) guidelines as at higher risk of pre-eclampsia. A total of 201 participants were recruited between 12 and 16 weeks of pregnancy and were asked to take two BP readings twice daily three times a week through their pregnancy. Primary outcomes were recruitment, retention and persistence of self-monitoring. Study recruitment and retention were analysed with descriptive statistics. Survival analysis was used to evaluate the persistence of self-monitoring and the performance of self-monitoring in the early detection of gestational hypertension, compared to clinic BP monitoring. Secondary outcomes were the mean clinic and self-monitored BP readings and the performance of self-monitoring in the detection of gestational hypertension and pre-eclampsia compared to clinic BP. Of 201 women recruited, 161 (80%) remained in the study at 36 weeks or to the end of their pregnancy, 162 (81%) provided any home readings suitable for analysis, 148 (74%) continued to self-monitor at 20 weeks and 107 (66%) at 36 weeks. Self-monitored readings were similar in value to contemporaneous matched clinic readings for both systolic and diastolic BP. Of the 23 who developed gestational hypertension or pre-eclampsia and self-monitored, 9 (39%) had a raised home BP prior to a raised clinic BP. Self-monitoring of BP in pregnancy is feasible and has potential to be useful in the early detection of gestational hypertensive disorders but maintaining self-monitoring throughout pregnancy requires support and probably enhanced training.

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.

Insulin Patch Pumps: Their Development and Future in Closed-Loop Systems

PubMed Central

Bohannon, Nancy J.V.

2010-01-01

Abstract Steady progress is being made toward the development of a so-called “artificial pancreas,” which may ultimately be a fully automated, closed-loop, glucose control system comprising a continuous glucose monitor, an insulin pump, and a controller. The controller will use individualized algorithms to direct delivery of insulin without user input. A major factor propelling artificial pancreas development is the substantial incidence of—and attendant patient, parental, and physician concerns about—hypoglycemia and extreme hyperglycemia associated with current means of insulin delivery for type 1 diabetes mellitus (T1DM). A successful fully automated artificial pancreas would likely reduce the frequency of and anxiety about hypoglycemia and marked hyperglycemia. Patch-pump systems (“patch pumps”) are likely to be used increasingly in the control of T1DM and may be incorporated into the artificial pancreas systems of tomorrow. Patch pumps are free of tubing, small, lightweight, and unobtrusive. This article describes features of patch pumps that have been approved for U.S. marketing or are under development. Included in the review is an introduction to control algorithms driving insulin delivery, particularly the two major types: proportional integrative derivative and model predictive control. The use of advanced algorithms in the clinical development of closed-loop systems is reviewed along with projected next steps in artificial pancreas development. PMID:20515308

A noninvasive estimation of cerebral perfusion pressure using critical closing pressure.

PubMed

Varsos, Georgios V; Kolias, Angelos G; Smielewski, Peter; Brady, Ken M; Varsos, Vassilis G; Hutchinson, Peter J; Pickard, John D; Czosnyka, Marek

2015-09-01

Cerebral blood flow is associated with cerebral perfusion pressure (CPP), which is clinically monitored through arterial blood pressure (ABP) and invasive measurements of intracranial pressure (ICP). Based on critical closing pressure (CrCP), the authors introduce a novel method for a noninvasive estimator of CPP (eCPP). Data from 280 head-injured patients with ABP, ICP, and transcranial Doppler ultrasonography measurements were retrospectively examined. CrCP was calculated with a noninvasive version of the cerebrovascular impedance method. The eCPP was refined with a predictive regression model of CrCP-based estimation of ICP from known ICP using data from 232 patients, and validated with data from the remaining 48 patients. Cohort analysis showed eCPP to be correlated with measured CPP (R = 0.851, p < 0.001), with a mean ± SD difference of 4.02 ± 6.01 mm Hg, and 83.3% of the cases with an estimation error below 10 mm Hg. eCPP accurately predicted low CPP (< 70 mm Hg) with an area under the curve of 0.913 (95% CI 0.883-0.944). When each recording session of a patient was assessed individually, eCPP could predict CPP with a 95% CI of the SD for estimating CPP between multiple recording sessions of 1.89-5.01 mm Hg. Overall, CrCP-based eCPP was strongly correlated with invasive CPP, with sensitivity and specificity for detection of low CPP that show promise for clinical use.

Drawing a line in the sand: Effectiveness of off-highway vehicle management in California's Sonoran desert

USGS Publications Warehouse

Custer, Nathan; Defalco, Lesley A.; Nussear, Kenneth E.; Esque, Todd C.

2017-01-01

Public land policies manage multiple uses while striving to protect vulnerable plant and wildlife habitats from degradation; yet the effectiveness of such policies are infrequently evaluated, particularly for remote landscapes that are difficult to monitor. We assessed the use and impacts of recreational vehicles on Mojave Desert washes (intermittent streams) in the Chemehuevi Desert Wildlife Management Area (DWMA) of southern California. Wash zones designated as open and closed to off-highway vehicle (OHV) activity were designed in part to protect Mojave desert tortoise (Gopherus agassizii) habitat while allowing recreation in designated areas. OHV tracks were monitored in washes located near access roads during winter and early spring holidays – when recreation is typically high – and at randomly dispersed locations away from roads. Washes near access roads had fewer vehicle tracks within closed than open zones; further away from roads, OHV tracks were infrequent and their occurrence was not different between wash designations. Washes were in better condition in closed zones following major holidays as indicated by less vegetation damage, presence of trash, and wash bank damage. Furthermore, the frequency of washes with live tortoises and their sign was marginally greater in closed than open wash zones. Collectively, these results suggest that low impacts to habitats in designated closed wash zones reflect public compliance with federal OHV policy and regulations in the Chemehuevi DWMA during our study. Future monitoring to contrast wash use and impacts during other seasons as well as in other DWMAs will elucidate spatial and temporal patterns of recreation in these important conservation areas.

Drawing a line in the sand: Effectiveness of off-highway vehicle management in California's Sonoran desert.

PubMed

Custer, Nathan A; DeFalco, Lesley A; Nussear, Kenneth E; Esque, Todd C

2017-05-15

Public land policies manage multiple uses while striving to protect vulnerable plant and wildlife habitats from degradation; yet the effectiveness of such policies are infrequently evaluated, particularly for remote landscapes that are difficult to monitor. We assessed the use and impacts of recreational vehicles on Mojave Desert washes (intermittent streams) in the Chemehuevi Desert Wildlife Management Area (DWMA) of southern California. Wash zones designated as open and closed to off-highway vehicle (OHV) activity were designed in part to protect Mojave desert tortoise (Gopherus agassizii) habitat while allowing recreation in designated areas. OHV tracks were monitored in washes located near access roads during winter and early spring holidays - when recreation is typically high - and at randomly dispersed locations away from roads. Washes near access roads had fewer vehicle tracks within closed than open zones; further away from roads, OHV tracks were infrequent and their occurrence was not different between wash designations. Washes were in better condition in closed zones following major holidays as indicated by less vegetation damage, presence of trash, and wash bank damage. Furthermore, the frequency of washes with live tortoises and their sign was marginally greater in closed than open wash zones. Collectively, these results suggest that low impacts to habitats in designated closed wash zones reflect public compliance with federal OHV policy and regulations in the Chemehuevi DWMA during our study. Future monitoring to contrast wash use and impacts during other seasons as well as in other DWMAs will elucidate spatial and temporal patterns of recreation in these important conservation areas. Published by Elsevier Ltd.

Guidelines for Adolescent Depression in Primary Care (GLAD-PC): Part II. Treatment and Ongoing Management.

PubMed

Cheung, Amy H; Zuckerbrot, Rachel A; Jensen, Peter S; Laraque, Danielle; Stein, Ruth E K

2018-02-26

To update clinical practice guidelines to assist primary care (PC) in the screening and assessment of depression. In this second part of the updated guidelines, we address treatment and ongoing management of adolescent depression in the PC setting. By using a combination of evidence- and consensus-based methodologies, the guidelines were updated in 2 phases as informed by (1) current scientific evidence (published and unpublished) and (2) revision and iteration among the steering committee, including youth and families with lived experience. These updated guidelines are targeted for youth aged 10 to 21 years and offer recommendations for the management of adolescent depression in PC, including (1) active monitoring of mildly depressed youth, (2) treatment with evidence-based medication and psychotherapeutic approaches in cases of moderate and/or severe depression, (3) close monitoring of side effects, (4) consultation and comanagement of care with mental health specialists, (5) ongoing tracking of outcomes, and (6) specific steps to be taken in instances of partial or no improvement after an initial treatment has begun. The strength of each recommendation and the grade of its evidence base are summarized. The Guidelines for Adolescent Depression in Primary Care cannot replace clinical judgment, and they should not be the sole source of guidance for adolescent depression management. Nonetheless, the guidelines may assist PC clinicians in the management of depressed adolescents in an era of great clinical need and a shortage of mental health specialists. Additional research concerning the management of depressed youth in PC is needed, including the usability, feasibility, and sustainability of guidelines, and determination of the extent to which the guidelines actually improve outcomes of depressed youth. Copyright © 2018 by the American Academy of Pediatrics.

Utility of nociceptive flexion reflex threshold and bispectral index to predict movement responses under propofol anaesthesia.

PubMed

Jakuscheit, Axel; Posch, Matthias J; Gkaitatzis, Stefanos; Neumark, Lisa; Hackbarth, Mark; Schneider, Martin; Lichtner, Gregor; Baars, Jan H; von Dincklage, Falk

2017-06-01

The nociceptive flexion reflex threshold (NFRT) is a promising tool to monitor analgesia during general anaesthesia. Clinical studies have shown that the NFRT allows to predict movement responses to painful stimuli under a combined anaesthetic regime of sedative and opioid agents. Experimental studies indicated that the NFRT is also able to predict such movement responses under an exclusively sedative regime like propofol mono-anaesthesia. Therefore, we performed this study to investigate the ability of the NFRT to predict movement responses to painful stimuli in patients during a clinical propofol mono-anaesthesia. We investigated 140 cardiac surgery patients during their postoperative phase under propofol mono-anaesthesia. NFRT and bispectral index (BIS) were determined in each patient right before endotracheal suctioning or painful electrical test stimulation. Prediction probabilities were calculated to quantify how accurate each measure is able to predict movement responses to the stimuli. The 124 patients included in the analysis received a median propofol dosage of 3.2 (2.5-3.9) [median (IQR)] mg/kg/h. The included patients showed 287 movement responses after a total of 725 investigated stimuli. The prediction probabilities for positive movement responses were 0.63 (95%CI: 0.59-0.67) for the NFRT and 0.69 (95%CI: 0.65-0.73) for the BIS. The NFRT allows the prediction of movement responses under propofol mono-anaesthesia, which confirms its utility as a monitor to predict movement responses under general anaesthesia. The BIS allows an even more accurate prediction, although it does not reflect the physiological structures of movement suppression, but correlates closely with the dose of propofol. German clinical trial register (DRKS00003062, Deutsches Register Klinischer Studien).

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.

Magnetic resonance imaging and transient elastography in the management of Nonalcoholic Fatty Liver Disease (NAFLD).

PubMed

Han, Ma Ai Thanda; Saouaf, Rola; Ayoub, Walid; Todo, Tsuyoshi; Mena, Edward; Noureddin, Mazen

2017-04-01

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease and cirrhosis worldwide and the second most common cause of liver transplantation in major medical centers. Because liver steatosis and fibrosis severity are related to disease morbidity and mortality, the extent of disease, and disease progression, they need to be assessed and monitored. In addition, innovation with new drug developments requires disease staging and monitoring in both phase 2 and 3 clinical trials. Currently, disease assessment in both clinical practice and research is mostly performed by liver biopsy, an invasive, procedure with risks. Noninvasive, highly accurate tests are needed that could be used in clinical trials as surrogate endpoints and in clinical practice for monitoring patients. Area Covered: We discuss noninvasive tests, transient elastography (TE) with controlled attenuation parameter (CAP), magnetic resonance imaging (MRI), and MR elastography (MRE), summarize the available evidence of their usefulness for assessing steatosis and fibrosis. Therefore they could be used as clinical trials outcomes and in disease monitoring in clinical practice. Expert Commentary: TE with CAP, MRI and MRE are highly accurate noninvasive diagnostic tools for quantifying hepatic steatosis and fibrosis. Therefore they could be used as clinical trials outcomes and in disease monitoring in clinical practice.

A randomized trial comparing INR monitoring devices in patients with anticoagulation self-management: evaluation of a novel error-grid approach.

PubMed

Hemkens, Lars G; Hilden, Kristian M; Hartschen, Stephan; Kaiser, Thomas; Didjurgeit, Ulrike; Hansen, Roland; Bender, Ralf; Sawicki, Peter T

2008-08-01

In addition to the metrological quality of international normalized ratio (INR) monitoring devices used in patients' self-management of long-term anticoagulation, the effectiveness of self-monitoring with such devices has to be evaluated under real-life conditions with a focus on clinical implications. An approach to evaluate the clinical significance of inaccuracies is the error-grid analysis as already established in self-monitoring of blood glucose. Two anticoagulation monitors were compared in a real-life setting and a novel error-grid instrument for oral anticoagulation has been evaluated. In a randomized crossover study 16 patients performed self-management of anticoagulation using the INRatio and the CoaguChek S system. Main outcome measures were clinically relevant INR differences according to established criteria and to the error-grid approach. A lower rate of clinically relevant disagreements according to Anderson's criteria was found with CoaguChek S than with INRatio without statistical significance (10.77% vs. 12.90%; P = 0.787). Using the error-grid we found principally consistent results: More measurement pairs with discrepancies of no or low clinical relevance were found with CoaguChek S, whereas with INRatio we found more differences with a moderate clinical relevance. A high rate of patients' satisfaction with both of the point of care devices was found with only marginal differences. A principal appropriateness of the investigated point-of-care devices to adequately monitor the INR is shown. The error-grid is useful for comparing monitoring methods with a focus on clinical relevance under real-life conditions beyond assessing the pure metrological quality, but we emphasize that additional trials using this instrument with larger patient populations are needed to detect differences in clinically relevant disagreements.

Post-Closure Report for Closed Resource Conservation and Recovery Act Corrective Action Units, Nevada National Security Site, Nevada: For Calendar Year 2017, Revision 0

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

Matthews, Patrick; Alvarado, Juan

This report serves as the combined annual report for post-closure activities for the following closed corrective action units (CAUs): CAU 90, Area 2 Bitcutter Containment CAU 91, Area 3 U-3fi Injection Well CAU 92, Area 6 Decon Pond Facility CAU 110, Area 3 WMD U-3ax/bl Crater CAU 111, Area 5 WMD Retired Mixed Waste Pits CAU 112, Area 23 Hazardous Waste Trenches The results of the inspections, a summary of maintenance activities, and an evaluation of monitoring data are presented in this report. Site inspections are conducted annually at CAUs 90, 91, and 112; semiannually at CAUs 92 and 110;more » and quarterly at CAU 111. Additional inspections are conducted at CAU 92 if precipitation occurs in excess of 1.0 inches in a 24-hour period and at CAU 111 if precipitation occurs in excess of 1.0 inch in a 24-hour period. Inspections include an evaluation of the condition of the units, including covers, fences, signs, gates, and locks. At CAU 110, soil moisture monitoring, vegetation evaluations, and subsidence surveys are conducted in addition to the visual inspections. At CAU 111, soil moisture monitoring, vegetation evaluations, subsidence surveys, direct radiation monitoring, air monitoring, radon flux monitoring, and groundwater monitoring are conducted. This report will address all monitoring items notes above except groundwater monitoring. Groundwater monitoring is documented in the Nevada National Security Site Data Report: Groundwater Monitoring Program Area 5 Radioactive Waste Management Site. All required inspections, maintenance, and monitoring were conducted in accordance with the post-closure requirements of the permit. Revision 4 of Permit NEV HW0101 was issued effective December 10, 2015, and remains in effect until December 10, 2020.« less

[Clinical, functional and biochemical characteristics of arterial hypertension in military men under chronic stress].

PubMed

Shpagina, L A; Ermakova, M A; Volkova, E A; Iakovleva, S A

2008-01-01

Peculiarities of military occupational activities are repeated stress and high degree of psychoemotional strain. The article deals with results of momentary study covering a select from military men cohort, with thyroid tests, renal functional tests, diurnal monitoring of blood pressure and psychologic state assessment. Course of arterial hypertension in military men subjected to chronic stress presents prevailing systolic-diastolic and diastolic variants with excessive decrease of blood pressure at night, with high values of albuminuria. Psychologic state of the military men examined, whe were subjects to chronic stress, was mostly mixed reactivity type with general overstrain and somatization of inner conflict (psychosomatic variant of dysadaptation). The authors demonstrated close correlation between intrinsic emotional strain degree with arterial hypertension type according to "hyper-dipper" variant and free T3 level.

Radiographic methods of wear analysis in total hip arthroplasty.

PubMed

Rahman, Luthfur; Cobb, Justin; Muirhead-Allwood, Sarah

2012-12-01

Polyethylene wear is an important factor in failure of total hip arthroplasty (THA). With increasing numbers of THAs being performed worldwide, particularly in younger patients, the burden of failure and revision arthroplasty is increasing, as well, along with associated costs and workload. Various radiographic methods of measuring polyethylene wear have been developed to assist in deciding when to monitor patients more closely and when to consider revision surgery. Radiographic methods that have been developed to measure polyethylene wear include manual and computer-assisted plain radiography, two- and three-dimensional techniques, and radiostereometric analysis. Some of these methods are important in both clinical and research settings. CT has the potential to provide additional information on component orientation and enables assessment of periprosthetic osteolysis, which is an important consequence of polyethylene wear.

Erroneous intracranial pressure measurements from simultaneous pressure monitoring and ventricular drainage catheters.

PubMed

Birch, A A; Eynon, C A; Schley, D

2006-01-01

The objective of this report is to highlight the potential for false pressure measurements from systems that combine intracranial pressure (ICP) measurement and ventricular drainage. If the ports of the drain become blocked to the extent that they present a high resistance to cerebrospinal fluid flow, then a significant pressure gradient between the inside and outside of the catheter may be established. Thus, any intracatheter transducer will faithfully record a pressure much lower than true ICP. This holds true for catheter-tip transducers when the transducer lies inside the catheter. In the absence of flow, however, pressures will equalize; therefore, accurate measurements may be taken if the drain is temporarily closed. We model this situation and provide simulations of expected measurements in such situations; these compare well to observed clinical readings.

Lymphadenopathy, productive cough, eosinophilia, and a new-onset acquired immunodeficiency syndrome.

PubMed

Dzhindzhikhashvili, Megi; Absy-Jaghab, Minou; Frieri, Marianne

2011-01-01

We present a complicated case of a human immunodeficiency virus (HIV)-infected male patient with a complexity of confounding and overlapping symptoms that can masquerade as another diagnosis. This is the case of a patient with multiple secondary sexually transmitted infectious diseases, lymphadenopathy, B-cell lymphoma, a productive cough, a clinical picture suggestive of pulmonary tuberculosis, eosinophilia, and a new-onset acquired immunodeficiency syndrome. Our presentation highlights those deteriorations seen in our patient as well as various underlying immunologic changes in the content of HIV infection. This case may not be unique, but less severe cases occur and can be underdiagnosed, indicating the need of timely screening, close evaluation, and monitoring of HIV-infected patients as well as those with high risk of acquiring HIV.

Experimental application of Business Process Management technology to manage clinical pathways: a pediatric kidney transplantation follow up case.

PubMed

Andellini, Martina; Fernandez Riesgo, Sandra; Morolli, Federica; Ritrovato, Matteo; Cosoli, Piero; Petruzzellis, Silverio; Rosso, Nicola

2017-11-03

To test the application of Business Process Management technology to manage clinical pathways, using a pediatric kidney transplantation as case study, and to identify the benefits obtained from using this technology. Using a Business Process Management platform, we implemented a specific application to manage the clinical pathway of pediatric patients, and monitored the activities of the coordinator in charge of the case management during a 6-month period (from June 2015 to November 2015) using two methodologies: the traditional procedure and the one under study. The application helped physicians and nurses to optimize the amount of time and resources devoted to management purposes. In particular, time reduction was close to 60%. In addition, the reduction of data duplication, the integrated event management and the efficient data collection improved the quality of the service. The use of Business Process Management technology, usually related to well-defined processes with high management costs, is an established procedure in multiple environments; its use in healthcare, however, is innovative. The use of already accepted clinical pathways is known to improve outcomes. The combination of these two techniques, well established in their respective areas of application, could represent a revolution in clinical pathway management. The study has demonstrated that the use of this technology in a clinical environment, using a proper architecture and identifying a well-defined process, leads to real benefits in terms of resources optimization and quality improvement.

A knowledge authoring tool for clinical decision support.

PubMed

Dunsmuir, Dustin; Daniels, Jeremy; Brouse, Christopher; Ford, Simon; Ansermino, J Mark

2008-06-01

Anesthesiologists in the operating room are unable to constantly monitor all data generated by physiological monitors. They are further distracted by clinical and educational tasks. An expert system would ideally provide assistance to the anesthesiologist in this data-rich environment. Clinical monitoring expert systems have not been widely adopted, as traditional methods of knowledge encoding require both expert medical and programming skills, making knowledge acquisition difficult. A software application was developed for use as a knowledge authoring tool for physiological monitoring. This application enables clinicians to create knowledge rules without the need of a knowledge engineer or programmer. These rules are designed to provide clinical diagnosis, explanations and treatment advice for optimal patient care to the clinician in real time. By intelligently combining data from physiological monitors and demographical data sources the expert system can use these rules to assist in monitoring the patient. The knowledge authoring process is simplified by limiting connective relationships between rules. The application is designed to allow open collaboration between communities of clinicians to build a library of rules for clinical use. This design provides clinicians with a system for parameter surveillance and expert advice with a transparent pathway of reasoning. A usability evaluation demonstrated that anesthesiologists can rapidly develop useful rules for use in a predefined clinical scenario.

Pharmacists' perspectives on monitoring adherence to treatment in Cystic Fibrosis.

PubMed

Mooney, Karen; Ryan, Cristín; Downey, Damian G

2016-04-01

Cystic Fibrosis (CF) management requires complex treatment regimens but adherence to treatment is poor and has negative health implications. There are various methods of measuring adherence, but little is known regarding the extent of adherence measurement in CF centres throughout the UK and Ireland. To determine the adherence monitoring practices in CF centres throughout the UK and Ireland, and to establish CF pharmacists' views on these practices. UK and Ireland Cystic Fibrosis Pharmacists' Group's annual meeting (2014). A questionnaire was designed, piloted and distributed to pharmacists attending the UK and Ireland Cystic Fibrosis Pharmacists' Group's annual meeting (2014). The main outcome measures were the methods of inhaled/nebulised antibiotic supply and the methods used to measure treatment adherence in CF centres. The questionnaire also ascertained the demographic information of participating pharmacists. Closed question responses were analysed using descriptive statistics. Open questions were analysed using content analysis. Twenty-one respondents (84 % response) were included in the analysis and were mostly from English centres (66.7 %). Detailed records of patients receiving their inhaled/nebulised antibiotics were lacking. Adherence was most commonly described to be measured at 'every clinic visit' (28.6 %) and 'occasionally' (28.6 %). Patient self-reported adherence was the most commonly used method of measuring adherence in practice (90.5 %). The availability of electronic adherence monitoring in CF centres did not guarantee its use. Pharmacists attributed an equal professional responsibility for adherence monitoring in CF to Consultants, Nurses and Pharmacists. Seventy-six percent of pharmacists felt that the current adherence monitoring practices within their own unit were inadequate and associated with the absence of sufficient specialist CF pharmacist involvement. Many suggested that greater specialist pharmacist involvement could facilitate improved adherence monitoring. Current adherence knowledge is largely based on self-report. Further work is required to establish the most appropriate method of adherence monitoring in CF centres, to improve the recording of adherence and to understand the impact of increased specialist pharmacist involvement on that adherence.

Depressive symptoms in nonresident african american fathers and involvement with their sons.

PubMed

Davis, R Neal; Caldwell, Cleopatra Howard; Clark, Sarah J; Davis, Matthew M

2009-12-01

Our objective was to determine whether paternal depressive symptoms were associated with less father involvement among African American fathers not living with their children (ie, nonresident fathers). We analyzed survey data for 345 fathers enrolled in a program for nonresident African American fathers and their preteen sons. Father involvement included measures of contact, closeness, monitoring, communication, and conflict. We used bivariate analyses and multivariate logistic regression analysis to examine associations between father involvement and depressive symptoms. Thirty-six percent of fathers reported moderate depressive symptoms, and 11% reported severe depressive symptoms. In bivariate analyses, depressive symptoms were associated with less contact, less closeness, low monitoring, and increased conflict. In multivariate analyses controlling for basic demographic features, fathers with moderate depressive symptoms were more likely to have less contact (adjusted odds ratio: 1.7 [95% confidence interval: 1.1-2.8]), less closeness (adjusted odds ratio: 2.1 [95% confidence interval: 1.3-3.5]), low monitoring (adjusted odds ratio: 2.7 [95% confidence interval: 1.4-5.2]), and high conflict (adjusted odds ratio: 2.1 [95% confidence interval: 1.2-3.6]). Fathers with severe depressive symptoms also were more likely to have less contact (adjusted odds ratio: 3.1 [95% confidence interval: 1.4-7.2]), less closeness (adjusted odds ratio: 2.6 [95% confidence interval: 1.2-5.7]), low monitoring (adjusted odds ratio: 2.8 [95% confidence interval: 1.1-7.1]), and high conflict (adjusted odds ratio: 2.6 [95% confidence interval: 1.1-5.9]). Paternal depressive symptoms may be an important, but modifiable, barrier for nonresident African American fathers willing to be more involved with their children.

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.

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

Dynamics of a Tularemia Outbreak in a Closely Monitored Free-Roaming Population of Wild House Mice.

PubMed

Dobay, Akos; Pilo, Paola; Lindholm, Anna K; Origgi, Francesco; Bagheri, Homayoun C; König, Barbara

2015-01-01

Infectious disease outbreaks can be devastating because of their sudden occurrence, as well as the complexity of monitoring and controlling them. Outbreaks in wildlife are even more challenging to observe and describe, especially when small animals or secretive species are involved. Modeling such infectious disease events is relevant to investigating their dynamics and is critical for decision makers to accomplish outbreak management. Tularemia, caused by the bacterium Francisella tularensis, is a potentially lethal zoonosis. Of the few animal outbreaks that have been reported in the literature, only those affecting zoo animals have been closely monitored. Here, we report the first estimation of the basic reproduction number R0 of an outbreak in wildlife caused by F. tularensis using quantitative modeling based on a susceptible-infected-recovered framework. We applied that model to data collected during an extensive investigation of an outbreak of tularemia caused by F. tularensis subsp. holarctica (also designated as type B) in a closely monitored, free-roaming house mouse (Mus musculus domesticus) population in Switzerland. Based on our model and assumptions, the best estimated basic reproduction number R0 of the current outbreak is 1.33. Our results suggest that tularemia can cause severe outbreaks in small rodents. We also concluded that the outbreak self-exhausted in approximately three months without administrating antibiotics.

Dynamics of a Tularemia Outbreak in a Closely Monitored Free-Roaming Population of Wild House Mice

PubMed Central

Dobay, Akos; Pilo, Paola; Lindholm, Anna K.; Origgi, Francesco; Bagheri, Homayoun C.; König, Barbara

2015-01-01

Infectious disease outbreaks can be devastating because of their sudden occurrence, as well as the complexity of monitoring and controlling them. Outbreaks in wildlife are even more challenging to observe and describe, especially when small animals or secretive species are involved. Modeling such infectious disease events is relevant to investigating their dynamics and is critical for decision makers to accomplish outbreak management. Tularemia, caused by the bacterium Francisella tularensis, is a potentially lethal zoonosis. Of the few animal outbreaks that have been reported in the literature, only those affecting zoo animals have been closely monitored. Here, we report the first estimation of the basic reproduction number R 0 of an outbreak in wildlife caused by F. tularensis using quantitative modeling based on a susceptible-infected-recovered framework. We applied that model to data collected during an extensive investigation of an outbreak of tularemia caused by F. tularensis subsp. holarctica (also designated as type B) in a closely monitored, free-roaming house mouse (Mus musculus domesticus) population in Switzerland. Based on our model and assumptions, the best estimated basic reproduction number R 0 of the current outbreak is 1.33. Our results suggest that tularemia can cause severe outbreaks in small rodents. We also concluded that the outbreak self-exhausted in approximately three months without administrating antibiotics. PMID:26536232

75 FR 63791 - Fisheries of the Northeastern United States; Atlantic Herring Fishery; Amendment 4

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

... reporting, interactions with river herring, access by midwater trawl vessels to groundfish closed areas, and interactions with the Atlantic mackerel fishery. In June 2009, the Council determined there was not sufficient... monitoring and reporting, interactions with river herring and Atlantic mackerel, access to groundfish closed...

Gas exchange in NASA's biomass production chamber - A preprototype closed human life support system

NASA Technical Reports Server (NTRS)

Corey, Kenneth A.; Wheeler, Raymond M.

1992-01-01

The unique capabilities of the NASA biomass production chamber for monitoring and evaluating gas exchange rates are examined. Special emphasis is given to results with wheat and soybeans. The potential of the chamber as a preprototype of a closed human life support system is considered.

Using SNPs with varying specificity to quantify hybridization between closely related but genetically distinct moth populations in the wild

USDA-ARS?s Scientific Manuscript database

Invasive insect species can potentially hybridize with closely related native populations to produce new phenotypes with deleterious economic and environmental consequences. Monitoring such events is often problematic because populations that can interbreed are typically sufficiently similar that it...

Safety Evaluation of an Automated Remote Monitoring System for Heart Failure in an Urban, Indigent Population.

PubMed

Gross-Schulman, Sandra; Sklaroff, Laura Myerchin; Hertz, Crystal Coyazo; Guterman, Jeffrey J

2017-12-01

Heart Failure (HF) is the most expensive preventable condition, regardless of patient ethnicity, race, socioeconomic status, sex, and insurance status. Remote telemonitoring with timely outpatient care can significantly reduce avoidable HF hospitalizations. Human outreach, the traditional method used for remote monitoring, is effective but costly. Automated systems can potentially provide positive clinical, fiscal, and satisfaction outcomes in chronic disease monitoring. The authors implemented a telephonic HF automated remote monitoring system that utilizes deterministic decision tree logic to identify patients who are at risk of clinical decompensation. This safety study evaluated the degree of clinical concordance between the automated system and traditional human monitoring. This study focused on a broad underserved population and demonstrated a safe, reliable, and inexpensive method of monitoring patients with HF.

40 CFR 63.1452 - What are my monitoring requirements?

Code of Federal Regulations, 2014 CFR

2014-07-01

... device, associated sensor(s), and recording equipment according to the manufacturers' specifications. Locate the sensor(s) used for monitoring in or as close to a position that provides a representative... section. (i) Locate the flow sensor and other necessary equipment such as straightening vanes in a...

40 CFR 63.1452 - What are my monitoring requirements?

Code of Federal Regulations, 2012 CFR

2012-07-01

... device, associated sensor(s), and recording equipment according to the manufacturers' specifications. Locate the sensor(s) used for monitoring in or as close to a position that provides a representative... section. (i) Locate the flow sensor and other necessary equipment such as straightening vanes in a...

40 CFR 63.773 - Inspection and monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 10 2010-07-01 2010-07-01 false Inspection and monitoring requirements. 63.773 Section 63.773 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... safe-to-inspect times. (6) Any parts of the closed-vent system or cover that are designated, as...

Using Smartphones to Monitor Bipolar Disorder Symptoms: A Pilot Study

PubMed Central

Kindermann, Sally; Maier, Andreas; Kerl, Christopher; Moock, Jörn; Barbian, Guido; Rössler, Wulf

2016-01-01

Background Relapse prevention in bipolar disorder can be improved by monitoring symptoms in patients' daily life. Smartphone apps are easy-to-use, low-cost tools that can be used to assess this information. To date, few studies have examined the usefulness of smartphone data for monitoring symptoms in bipolar disorder. Objective We present results from a pilot test of a smartphone-based monitoring system, Social Information Monitoring for Patients with Bipolar Affective Disorder (SIMBA), that tracked daily mood, physical activity, and social communication in 13 patients. The objective of this study was to investigate whether smartphone measurements predicted clinical symptoms levels and clinical symptom change. The hypotheses that smartphone measurements are (1) negatively related to clinical depressive symptoms and (2) positively related to clinical manic symptoms were tested. Methods Clinical rating scales were administered to assess clinical depressive and manic symptoms. Patients used a smartphone with the monitoring app for up to 12 months. Random-coefficient multilevel models were computed to analyze the relationship between smartphone data and externally rated manic and depressive symptoms. Overall clinical symptom levels and clinical symptom changes were predicted by separating between-patient and within-patient effects. Using established clinical thresholds from the literature, marginal effect plots displayed clinical relevance of smartphone data. Results Overall symptom levels and change in clinical symptoms were related to smartphone measures. Higher overall levels of clinical depressive symptoms were predicted by lower self-reported mood measured by the smartphone (beta=-.56, P<.001). An increase in clinical depressive symptoms was predicted by a decline in social communication (ie, outgoing text messages: beta=-.28, P<.001) and a decline in physical activity as measured by the smartphone (ie, cell tower movements: beta=-.11, P=.03). Higher overall levels of clinical manic symptoms were predicted by lower physical activity on the smartphone (ie, distance travelled: beta=-.37, P<.001), and higher social communication (beta=.48, P=.03). An increase in clinical manic symptoms was predicted by a decrease in physical activity on the smartphone (beta=-.17, P<.001). Conclusions Clinical symptoms were related to some objective and subjective smartphone measurements, but not all smartphone measures predicted the occurrence of bipolar symptoms above clinical thresholds. Thus, smartphones have the potential to monitor bipolar disorder symptoms in patients’ daily life. Further validation of monitoring tools in a larger sample is needed. Conclusions are limited by the low prevalence of manic and depressive symptoms in the study sample. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 05663421; http://www.controlled-trials.com/ISRCTN05663421 (Archived by WebCite at http://www.webcitation.org/6d9wsibJB) PMID:26740354

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...

Making an implant-level impression using solid plastic, press-fit, closed-tray impression copings: a clinical report.

PubMed

Selecman, Audrey M; Wicks, Russell A

2009-03-01

An implant-level impression is often desired for designing and fabricating an implant-supported fixed restoration, especially when 2 or more implants have been placed. However, convergent implants placed too close in proximity pose several problems, starting with the impression. In situations of extreme convergence or close proximity, modification of conventional metal copings may be impossible. This clinical report describes the use and associated advantages and disadvantages of solid plastic, press-fit, closed-tray impression copings as a mechanism suitable to create an implant-level cast.

Cost-Effectiveness of Different Strategies to Monitor Adults on Antiretroviral Treatment: A Combined Analysis of Three Mathematical Models

PubMed Central

Keebler, Daniel; Revill, Paul; Braithwaite, Scott; Phillips, Andrew; Blaser, Nello; Borquez, Annick; Cambiano, Valentina; Ciaranello, Andrea; Estill, Janne; Gray, Richard; Hill, Andrew; Keiser, Olivia; Kessler, Jason; Menzies, Nicolas A; Nucifora, Kimberly A; Vizcaya, Luisa Salazar; Walker, Simon; Welte, Alex; Easterbrook, Philippa; Doherty, Meg; Hirnschall, Gottfried; Hallett, Timothy B

2015-01-01

Background The WHO’s 2013 revisions to its Consolidated Guidelines on ARVs will recommend routine viral load monitoring (VLM), rather than clinical or immunological monitoring, as the preferred monitoring approach on the basis of clinical evidence. However, HIV programmes in resource-limited settings require guidance on the most cost-effective use of resources given other competing priorities, including expansion of ART coverage. Here we assess the cost-effectiveness of alternative patient monitoring strategies. Methods A range of monitoring strategies was evaluated, including clinical, CD4 and viral load monitoring alone and together at different frequencies and with different criteria for switching to second-line therapies. Three independently-constructed and validated models were analysed simultaneously. Costs were estimated based on resource use projected in the models and associated unit costs; impact was quantified as disability-adjusted life years (DALYs) averted. Alternatives were compared using incremental cost-effectiveness analysis. Results All models show that clinical monitoring delivers significant benefit compared to a hypothetical baseline scenario with no monitoring or switching. Regular CD4 cell count monitoring confers a benefit over clinical monitoring alone, at an incremental cost that makes it affordable in more settings than VLM, which is currently more expensive. VLM without CD4 every six to 12 months provides the greatest reductions in morbidity and mortality, but incurs a high cost per DALY averted, resulting in lost opportunities to generate health gains if implemented instead of increasing ART coverage or expanding ART eligibility. Interpretation The priority for HIV programmes should be to expand ART coverage, firstly at CD4 <350 cells and then at CD4 <500, using lower-cost clinical or CD4 monitoring. At current costs, VLM should be considered only after high ART coverage has been achieved. Point-of-care technologies and other factors reducing costs may make VLM more affordable in future. Funding The HIV Modelling Consortium is funded by the Bill and Melinda Gates Foundation. Funding for this work was also provided by the World Health Organization. PMID:25104633

Stepping-Motion Motor-Control Subsystem For Testing Bearings

NASA Technical Reports Server (NTRS)

Powers, Charles E.

1992-01-01

Control subsystem closed-loop angular-position-control system causing motor and bearing under test to undergo any of variety of continuous or stepping motions. Also used to test bearing-and-motor assemblies, motors, angular-position sensors including rotating shafts, and like. Monitoring subsystem gathers data used to evaluate performance of bearing or other article under test. Monitoring subsystem described in article, "Monitoring Subsystem For Testing Bearings" (GSC-13432).

76 FR 79689 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

...] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees AGENCY: Food... establishment and operation of clinical trial data monitoring committees. DATES: Submit either electronic or...

40 CFR 63.1452 - What are my monitoring requirements?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., associated sensor(s), and recording equipment according to the manufacturers' specifications. Locate the sensor(s) used for monitoring in or as close to a position that provides a representative measurement of... the flow sensor and other necessary equipment such as straightening vanes in a position that provides...

Performance Monitoring: Evaluating a Wheat Straw PRB for Nitrate Removal at an Agricultural Operation

EPA Science Inventory

The U.S. EPA Office of Research and Development’s National Risk Management Research Laboratory (NRMRL) is conducting long-term monitoring of a wheat straw permeable reactive barrier (PRB) for remediation of ground water contaminated with nitrate from a now-closed swine concentrat...

Monitoring and predicting shrink potential and future processing quality of potato tubers

USDA-ARS?s Scientific Manuscript database

Long-term storage of potato tubers increases risks, which are often attributed to shrink and quality loss. To minimize shrink and ensure high quality tubers, producers must closely monitor the condition of the crop during storage and make necessary adjustments to management plans. Evaluation procedu...

40 CFR 63.653 - Monitoring, recordkeeping, and implementation plan for emissions averaging.

Code of Federal Regulations, 2013 CFR

2013-07-01

... § 63.120 of subpart G; and (ii) For closed vent systems with control devices, conduct an initial design..., monitoring, recordkeeping, and reporting equivalent to that required for Group 1 emission points complying... control device. (2) The source shall implement the following procedures for each miscellaneous process...

EPA/ORD WORKSHOP ON SOURCE EMISSION AND AMBIENT AIR MONITORING OF MERCURY. OPENING & CLOSING REMARKS AND OVERVIEW

EPA Science Inventory

The Mercury Monitoring Workshop was developed because mercury contamination, both nationally and internationally, has long been recognized as a growing problem for both humans and ecosystems. Mercury is released to the environment from a variety of human (anthropogenic) sources i...

EFFECT OF LOW LEVEL CARBON MONOXIDE ON COMPENSATORY TRACKING AND EVENT MONITORING

EPA Science Inventory

Experiments by Putz et al. concerning the effect of carbon monoxide (CO) exposure on compensatory tracking and monitoring in healthy young men were replicated. Task and procedural variables were reproduced as closely as practical. Subjects were exposed to either room air or 100 p...

Development and Progression of a Model: Prospective Research Compliance Monitoring

ERIC Educational Resources Information Center

Fedor, Carol; Ferrazzano Yaussy, Cristina; Cola, Philip A.

2008-01-01

Recent trends in Human Research Protection Programs (HRPPs) have contributed to the rising emphasis on prospective monitoring of clinical research and education programs. Therefore, internal efforts and resources to monitor investigator compliance and site performance have become an important focus in the conduct of clinical research. Once the…

Patient monitoring in the operating theatre.

PubMed

Forrest, A L; Douglas, D M; Rimmer, A R

1976-09-01

Anaesthetised patients are monitored to ensure their safety. Simple clinical observations must not be replaced by electronic instruments--these provide an extension of the clinical senses. The choice of parameters for monitoring is discussed. The design of the Ninewells main operating theatre suite is described. An 8-channel bourne in the base of the theatre table conveys patient signals to a 4-channel recorder in a monitoring laboratory. Outputs are displayed on a wall mounted display in theatre. Two-way speech intercommunication exists with monitoring technician and students.

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.

Predicting Out-of-Office Blood Pressure in the Clinic for the Diagnosis of Hypertension in Primary Care: An Economic Evaluation.

PubMed

Monahan, Mark; Jowett, Sue; Lovibond, Kate; Gill, Paramjit; Godwin, Marshall; Greenfield, Sheila; Hanley, Janet; Hobbs, F D Richard; Martin, Una; Mant, Jonathan; McKinstry, Brian; Williams, Bryan; Sheppard, James P; McManus, Richard J

2018-02-01

Clinical guidelines in the United States and United Kingdom recommend that individuals with suspected hypertension should have ambulatory blood pressure (BP) monitoring to confirm the diagnosis. This approach reduces misdiagnosis because of white coat hypertension but will not identify people with masked hypertension who may benefit from treatment. The Predicting Out-of-Office Blood Pressure (PROOF-BP) algorithm predicts masked and white coat hypertension based on patient characteristics and clinic BP, improving the accuracy of diagnosis while limiting subsequent ambulatory BP monitoring. This study assessed the cost-effectiveness of using this tool in diagnosing hypertension in primary care. A Markov cost-utility cohort model was developed to compare diagnostic strategies: the PROOF-BP approach, including those with clinic BP ≥130/80 mm Hg who receive ambulatory BP monitoring as guided by the algorithm, compared with current standard diagnostic strategies including those with clinic BP ≥140/90 mm Hg combined with further monitoring (ambulatory BP monitoring as reference, clinic, and home monitoring also assessed). The model adopted a lifetime horizon with a 3-month time cycle, taking a UK Health Service/Personal Social Services perspective. The PROOF-BP algorithm was cost-effective in screening all patients with clinic BP ≥130/80 mm Hg compared with current strategies that only screen those with clinic BP ≥140/90 mm Hg, provided healthcare providers were willing to pay up to £20 000 ($26 000)/quality-adjusted life year gained. Deterministic and probabilistic sensitivity analyses supported the base-case findings. The PROOF-BP algorithm seems to be cost-effective compared with the conventional BP diagnostic options in primary care. Its use in clinical practice is likely to lead to reduced cardiovascular disease, death, and disability. © 2017 American Heart Association, Inc.

Diffuse optical monitoring of peripheral tissues during uncontrolled internal hemorrhage in a porcine model

PubMed Central

Vishwanath, Karthik; Gurjar, Rajan; Wolf, David; Riccardi, Suzannah; Duggan, Michael; King, David

2018-01-01

Reliable, continuous and noninvasive blood flow and hemoglobin monitoring in trauma patients remains a critical, but generally unachieved goal. Two optical sensing methods - diffuse correlation spectroscopy (DCS) and diffuse reflectance spectroscopy (DRS) – are used to monitor and detect internal hemorrhage. Specifically, we investigate if cutaneous perfusion measurements acquired using DCS and DRS in peripheral (thighs and ear-lobe) tissues could detect severe hemorrhagic shock in a porcine model. Four animals underwent high-grade hepato-portal injury in a closed abdomen, to induce uncontrolled hemorrhage and were subsequently allowed to bleed for 10 minutes before fluid resuscitation. DRS and DCS measurements of cutaneous blood flow were acquired using fiber optical probes placed on the thigh and earlobe of the animals and were obtained repeatedly starting from 1 to 5 minutes pre-injury, up to several minutes post shock. Clear changes were observed in measured optical spectra across all animals at both sites. DCS-derived cutaneous blood flow decreased sharply during hemorrhage, while DRS-derived vascular saturation and hemoglobin paralleled cardiac output. All derived optical parameters had the steepest changes during the rapid initial hemorrhage unambiguously. This suggests that a combined DCS and DRS based device might provide an easy-to-use, non-invasive, internal-hemorrhage detection system that can be used across a wide array of clinical settings. PMID:29552394

Professional and patient attitudes to using mobile phone technology to monitor asthma: questionnaire survey.

PubMed

Pinnock, Hilary; Slack, Roger; Pagliari, Claudia; Price, David; Sheikh, Aziz

2006-08-01

There is increasing international interest in using emerging technologies to enhance chronic disease management. We aimed to explore the attitudes of patients and primary care professionals to using mobile technology in order to monitor asthma. A piloted questionnaire containing closed and open-ended questions assessing attitudes to using electronic self-monitoring was posted to a random sample of general practitioners, asthma nurses, and people with asthma (12 years and over) in Lothian and Kent, UK, with 2 reminders. In addition to descriptive statistics, patient and clinician responses were compared using Chi-squared or independent sample t-tests. Free-text responses were analysed thematically. Responses were obtained from 130/300 professionals (43%) and 202/389 patients (52%). Patients rated the technology positively and considered that it may help clinicians to provide care, especially during acute attacks. Although rated similarly, professionals were more sceptical about benefits. Both professionals and patients had concerns about the time and cost implications. Of the respondents, 28 professionals (10%) and 62 patients (16%) returned uncompleted questionnaires citing lack of perceived relevance. The low completion rate probably reflects the current status of mobile phone-facilitated care as a minority interest for 'early adopters' of technology. Even for the enthusiastic minority, using mobile phone technology raised questions of clinical benefit, impact on self-management, and concerns about workload and cost, which will need to be addressed prior to wider acceptance.

Aversive tension of adolescents with anorexia nervosa in daily course: a case-controlled and smartphone-based ambulatory monitoring trial.

PubMed

Kolar, David Raphael; Bürger, Arne; Hammerle, Florian; Jenetzky, Ekkehart

2014-04-23

Monitoring and reduction of aversive tension is a core issue in dialectical behaviour therapy of patients. It has been shown that aversive tension is increased in adult borderline personality disorder and is linked to low emotion labelling ability. However, until now there is no documented evidence that patients with anorexia nervosa suffer from aversive tension as well. Furthermore the usability of a smartphone application for ambulatory monitoring purposes has not been sufficiently explored. We compare the mean and maximum self-reported aversive tension in 20 female adolescents (12-19 years) with anorexia nervosa in outpatient treatment with 20 healthy controls. They are required to answer hourly, over a 2-day period, that is, about 30 times, four short questions on their smartphone, which ensures prompt documentation without any recall bias. At the close out, the participants give a structured usability feedback on the application and the procedure. The achieved result of this trial has direct relevance for efficient therapy strategies and is a prerequisite for trials regarding dialectical behaviour therapy in anorexia nervosa. The results will be disseminated through peer-review publications. The ethics committee of the regional medical association in Mainz, Germany approved the study protocol under the reference number 837.177.13. The trial is registered at the German clinical trials registration under the reference number DRKS00005228.

Closed Versus Open Supracondylar Fractures of the Humerus in Children: A Comparison of Clinical and Radiographic Presentation and Results.

PubMed

Lewine, Eliza; Kim, Jaehon M; Miller, Patricia E; Waters, Peter M; Mahan, Susan T; Snyder, Brian; Hedequist, Daniel; Bae, Donald S

2018-02-01

The purpose of this investigation was to compare the presentation and postoperative results of children treated for open and closed, completely displaced type III supracondylar humerus fractures (SCFs). Thirty patients with open and 66 patients with closed, completely displaced type III SCFs were evaluated. Open fractures underwent irrigation and debridement, and all patients were treated by open or closed reduction and pin fixation. Medical records were reviewed to obtain demographic information as well as preoperative and postoperative clinical data regarding mechanism of injury, neurovascular status, associated injuries, postoperative range of motion, infections, and pain. Radiographs were evaluated to quantify displacement, Baumann's angle, humeral capitellar angle, position of the anterior humeral line, and adequacy of reduction. Outcomes were assessed using Flynn criteria. Mean clinical follow-up for the open and closed fracture groups was 8.9 and 5.7 months, respectively. Both groups were similar with respect to age, sex distribution, weight and body mass index, laterality of involvement, and mechanism of injury. At presentation, 35% of closed SCFs and 23% of open SCFs presented with abnormal neurovascular status. There was a higher prevalence of diminished/absent pulses or distal limb ischemia in patients with open injuries (27%) compared with closed fractures (18%). Conversely, severely displaced closed fractures were more commonly associated with nerve injury/palsy at presentation (35%) than those with open fractures (23%). Spontaneous nerve recovery was seen in 87% within 3 to 6 months. Postoperative loss of reduction and malunion were more common in the closed fracture group. However, 84% of patients achieved good-to-excellent results by Flynn criteria, with no appreciable difference based upon open versus closed fractures. With timely wound and fracture treatment, the clinical and radiographic results of children treated for open SCFs is similar to those with closed type III injuries, with little increased risk for infection, malunion, or neurovascular compromise. Level III.

Between-day reliability of centre of pressure measures for balance assessment in hemiplegic stroke patients.

PubMed

Gasq, David; Labrunée, Marc; Amarantini, David; Dupui, Philippe; Montoya, Richard; Marque, Philippe

2014-03-21

Stroke patients have impaired postural balance that increases the risk of falls and impairs their mobility. Assessment of postural balance is commonly carried out by recording centre of pressure (CoP) displacements, but the lack of data concerning reliability of these measures compromises their interpretation. The purpose of this study was to investigate the between-day reliability of six CoP-based variables, in order to provide i) reliability data for monitoring postural sway and weight-bearing asymmetry of stroke patients in clinical practice and ii) consistent assessment method of measurement error for applications in physical medicine and rehabilitation. Postural balance of 20 stroke patients was assessed in quiet standing on a force platform, in two sessions, 7 days apart. Six CoP-based variables were collected in eyes open and eyes closed conditions: postural sway was assessed with mean and standart deviation of CoP-velocity, CoP-velocity along the mediolateral and anteroposterior axes, and confidence ellipse area (CE(AREA)); weight-bearing asymmetry was assessed with mean CoP position along the mediolateral axis (CoP(ML)). The intraclass correlation coefficient (ICC) was used to determine the level of agreement between test-retest. Small real difference (SRD), corresponding to the smallest change that indicates a real improvement for a single individual, was used to determine the extent of measurement error. ICCs were satisfactory (>0.9) for all CoP-based variables, except for CE(AREA) in eyes open condition and CoP(ML) (<0.8). The SRDs (eyes open/closed conditions) were: 6.1/9.5 mm.s(-1) for mean velocity; 12.3/12.2 mm.s(-1) for standard deviation of CoP-velocity; 3.6/5.5 mm.s(-1) and 4.9/7.3 mm.s(-1) for CoP-velocity in mediolateral and anteroposterior axes, respectively; 17.4/21.4 mm for CoP(ML). Because CE(AREA) showed heteroscedasticity of measurement error distribution, SRD (eyes open/closed conditions) was expressed as a percentage (121/75%) and a ratio (3.68/2.16) obtained after log-antilog procedure. In clinical practice, the CoP-based velocity variables should be prefer to CE(AREA) to assess and monitor postural sway over time in hemiplegic stroke patients. The poor reliability of CoP(ML) compromises its use to assess weight-bearing asymmetry. The procedure we used could be applied in reliability studies concerning other CoP-based variables or other biological variables in the field of physical medicine and rehabilitation.

Catheter‐associated venous air embolism in hospitalized horses: 32 cases

PubMed Central

McKenzie, Harold C.; Barton, Michelle H.; Davis, Jennifer L.; Dunkel, Bettina; Johnson, Amy L.; MacDonald, Elizabeth S.

2018-01-01

Background Venous air embolism is a potentially life‐threatening complication of IV catheter use in horses. Despite widespread anecdotal reports of their occurrence, few cases have been reported in the literature and the prognosis is currently unknown. Hypothesis/Objectives Our objective was to describe the surrounding circumstances, clinical signs, treatment, progression, and outcome of venous air embolism in hospitalized horses. Animals Thirty‐two horses with acute onset of compatible clinical signs associated with IV catheter disconnection or damage. Methods Multicenter retrospective study. Data extracted from clinical records included signalment, presenting complaint, catheter details, clinical signs, treatments, and outcome. Results Most cases resulted from extension set disconnection occurring within approximately 24 hours after catheter placement. In fewer horses, extension set damage was cited as a cause. Common clinical signs included tachycardia, tachypnea, recumbency, muscle fasciculations and agitation, with abnormal behavior including kicking and flank biting. Less commonly, pathological arrhythmias or more severe neurologic signs, including blindness and seizures, were noted. Progression was unpredictable, with some affected horses developing delayed‐onset neurologic signs. Mortality was 6/32 (19%), including 2 cases of sudden death and other horses euthanized because of persistent neurologic deficits. Negative outcomes were more common in horses with recorded blindness, sweating or recumbency, but blindness resolved in 5/8 affected horses. Conclusions and Clinical Importance The prognosis for resolution of clinical signs after air embolism is fair, but permanent neurologic deficits or pathologic cardiac arrhythmias can arise. Unpredictable progression warrants close monitoring. Systematic clinic‐based surveillance could provide additional useful information to aid prevention. PMID:29460300

Simultaneous monitoring of static and dynamic intracranial pressure parameters from two separate sensors in patients with cerebral bleeds: comparison of findings.

PubMed

Eide, Per Kristian; Holm, Sverre; Sorteberg, Wilhelm

2012-09-07

We recently reported that in an experimental setting the zero pressure level of solid intracranial pressure (ICP) sensors can be altered by electrostatics discharges. Changes in the zero pressure level would alter the ICP level (mean ICP); whether spontaneous changes in mean ICP happen in clinical settings is not known. This can be addressed by comparing the ICP parameters level and waveform of simultaneous ICP signals. To this end, we retrieved our recordings in patients with cerebral bleeds wherein the ICP had been recorded simultaneously from two different sensors. During a time period of 10 years, 17 patients with cerebral bleeds were monitored with two ICP sensors simultaneously; sensor 1 was always a solid sensor while Sensor 2 was a solid -, a fluid - or an air-pouch sensor. The simultaneous signals were analyzed with automatic identification of the cardiac induced ICP waves. The output was determined in consecutive 6-s time windows, both with regard to the static parameter mean ICP and the dynamic parameters (mean wave amplitude, MWA, and mean wave rise time, MWRT). Differences in mean ICP, MWA and MWRT between the two sensors were determined. Transfer functions between the sensors were determined to evaluate how sensors reproduce the ICP waveform. Comparing findings in two solid sensors disclosed major differences in mean ICP in 2 of 5 patients (40%), despite marginal differences in MWA, MWRT, and linear phase magnitude and phase. Qualitative assessment of trend plots of mean ICP and MWA revealed shifts and drifts of mean ICP in the clinical setting. The transfer function analysis comparing the solid sensor with either the fluid or air-pouch sensors revealed more variable transfer function magnitude and greater differences in the ICP waveform derived indices. Simultaneous monitoring of ICP using two solid sensors may show marked differences in static ICP but close to identity in dynamic ICP waveforms. This indicates that shifts in ICP baseline pressure (sensor zero level) occur clinically; trend plots of the ICP parameters also confirm this. Solid sensors are superior to fluid - and air pouch sensors when evaluating the dynamic ICP parameters.

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

Enhanced clinical-scale manufacturing of TCR transduced T-cells using closed culture system modules.

PubMed

Jin, Jianjian; Gkitsas, Nikolaos; Fellowes, Vicki S; Ren, Jiaqiang; Feldman, Steven A; Hinrichs, Christian S; Stroncek, David F; Highfill, Steven L

2018-01-24

Genetic engineering of T-cells to express specific T cell receptors (TCR) has emerged as a novel strategy to treat various malignancies. More widespread utilization of these types of therapies has been somewhat constrained by the lack of closed culture processes capable of expanding sufficient numbers of T-cells for clinical application. Here, we evaluate a process for robust clinical grade manufacturing of TCR gene engineered T-cells. TCRs that target human papillomavirus E6 and E7 were independently tested. A 21 day process was divided into a transduction phase (7 days) and a rapid expansion phase (14 days). This process was evaluated using two healthy donor samples and four samples obtained from patients with epithelial cancers. The process resulted in ~ 2000-fold increase in viable nucleated cells and high transduction efficiencies (64-92%). At the end of culture, functional assays demonstrated that these cells were potent and specific in their ability to kill tumor cells bearing target and secrete large quantities of interferon and tumor necrosis factor. Both phases of culture were contained within closed or semi-closed modules, which include automated density gradient separation and cell culture bags for the first phase and closed GREX culture devices and wash/concentrate systems for the second phase. Large-scale manufacturing using modular systems and semi-automated devices resulted in highly functional clinical-grade TCR transduced T-cells. This process is now in use in actively accruing clinical trials and the NIH Clinical Center and can be utilized at other cell therapy manufacturing sites that wish to scale-up and optimize their processing using closed systems.

Increasing the reliability of solution exchanges by monitoring solenoid valve actuation.

PubMed

Auzmendi, Jerónimo Andrés; Moffatt, Luciano

2010-01-15

Solenoid valves are a core component of most solution perfusion systems used in neuroscience research. As they open and close, they control the flow of solution through each perfusion line, thereby modulating the timing and sequence of chemical stimulation. The valves feature a ferromagnetic plunger that moves due to the magnetization of the solenoid and returns to its initial position with the aid of a spring. The delays between the time of voltage application or removal and the actual opening or closing of the valve are difficult to predict beforehand and have to be measured experimentally. Here we propose a simple method for monitoring whether and when the solenoid valve opens and closes. The proposed method detects the movement of the plunger as it generates a measurable signal on the solenoid that surrounds it. Using this plunger signal, we detected the opening and closing of diaphragm and pinch solenoid valves with a systematic error of less than 2ms. After this systematic error is subtracted, the trial-to-trial error was below 0.2ms.

Illustrative cases for monitoring by quantitative analysis of BRAF/NRAS ctDNA mutations in liquid biopsies of metastatic melanoma patients who gained clinical benefits from anti-PD1 antibody therapy.

PubMed

Seremet, Teofila; Planken, Simon; Schreuer, Max; Jansen, Yanina; Delaunoy, Mélanie; El Housni, Hakim; Lienard, Danielle; Del Marmol, Véronique; Heimann, Pierre; Neyns, Bart

2018-02-01

Anti-programmed death 1 (PD-1) monoclonal antibodies improve the survival of metastatic melanoma patients. Predictive or monitoring biomarkers for response to this therapy could improve the clinical management of these patients. To date, no established biomarkers are available for monitoring the response to immunotherapy. Tumor- specific mutations in circulating tumor DNA (ctDNA) such as BRAF and NRAS mutations for melanoma patients have been proposed for monitoring of immunotherapy response. We present seven illustrative cases for the use of ctDNA BRAF and NRAS mutations' monitoring in plasma. The cases described exemplify four distinct clinical benefit patterns: rapid and durable complete response (CR), early progression, followed by CR, CR followed by early progression after interrupting treatment and long-term disease stabilization. These representative cases suggest that comprehensive BRAF/NRAS ctDNA monitoring during anti-PD1 therapy is informative and can be of added value for the monitoring of melanoma patients gaining clinical benefit on anti-PD1 treatment. An important advantage of our approach is that using the cartridge system on the Idylla platform for mutation analysis, the results become available the same day 2 h after plasma collection. Therefore, in the future, the ctDNA level can be an element in the clinical management of the patients.

First report of carp oedema virus infection of koi (Cyprinus carpio haematopterus) in the Republic of Korea.

PubMed

Kim, S W; Jun, J W; Giri, S S; Chi, C; Yun, S; Kim, H J; Kim, S G; Kang, J W; Park, S C

2018-04-01

Twenty-five koi (Cyprinus carpio haematopterus) bought from a wholesale fish market in Korea, showed lethargic behaviour and 100% mortality within 20 days. Carp oedema virus (CEV) was detected by PCR in all 25 koi. Results of detailed histopathological and clinical examinations of 17 koi indicated loss of body balance, severe infiltration of inflammatory cells into the inter-lamellar spaces of the gills and vacuolization and inclusion bodies in gill epithelial cells. Sequence analysis of PCR products of these koi showed up to 99% identity to the previously reported sequences, suggesting that the observed mass mortality resulted from koi sleepy disease (KSD) due to CEV infection. To the best of our knowledge, this study is the first report of KSD in the Republic of Korea. Partial sequences of 4a protein from the virus indicated that the present CEV detected in koi from Korea is more closely related to that from the UK and Poland than from Japan. The present findings indicate that the prevalence and spread of KSD must be closely monitored in both European and Asian countries to avoid potential economic losses to the global koi industry. © 2017 Blackwell Verlag GmbH.

Pathology consultation on anticoagulation monitoring: factor X-related assays.

PubMed

Wool, Geoffrey D; Lu, Chuanyi M

2013-11-01

To review various anticoagulation therapies and related laboratory monitoring issues, with a focus on factor X-related chromogenic assays. A case-based approach is used to review pertinent published literatures and product inserts of anticoagulation drugs and to look back on clinical use of factor X-related chromogenic assays. The number of anticoagulants available to clinicians has increased greatly in the past decade. Whether and how these anticoagulants should be monitored are areas of uncertainty for clinicians, which can lead to misuse of laboratory assays and suboptimal patient management. Factor X-related assays are of particular concern because of the similar and often confusing test names. Based on a common clinical case scenario and literature review regarding anticoagulant monitoring, an up-to-date discussion and review of the various factor X-related assays are provided, focusing on the differences in test designs and clinical utilities between the chromogenic anti-Xa and chromogenic factor X activity assays. Anticoagulation therapy and related laboratory monitoring are rapidly evolving areas of clinical practices. A good knowledge of relevant laboratory assays and their clinical applications is necessary to help optimize patient care.

Internet Searches and Their Relationship to Cognitive Function in Older Adults: Cross-Sectional Analysis

PubMed Central

Hollingshead, Kristy; Kaye, Jeffrey

2017-01-01

Background Alzheimer disease (AD) is a very challenging experience for all those affected. Unfortunately, detection of Alzheimer disease in its early stages when clinical treatments may be most effective is challenging, as the clinical evaluations are time-consuming and costly. Recent studies have demonstrated a close relationship between cognitive function and everyday behavior, an avenue of research that holds great promise for the early detection of cognitive decline. One area of behavior that changes with cognitive decline is language use. Multiple groups have demonstrated a close relationship between cognitive function and vocabulary size, verbal fluency, and semantic ability, using conventional in-person cognitive testing. An alternative to this approach which is inherently ecologically valid may be to take advantage of automated computer monitoring software to continually capture and analyze language use while on the computer. Objective The aim of this study was to understand the relationship between Internet searches as a measure of language and cognitive function in older adults. We hypothesize that individuals with poorer cognitive function will search using fewer unique terms, employ shorter words, and use less obscure words in their searches. Methods Computer monitoring software (WorkTime, Nestersoft Inc) was used to continuously track the terms people entered while conducting searches in Google, Yahoo, Bing, and Ask.com. For all searches, punctuation, accents, and non-ASCII characters were removed, and the resulting search terms were spell-checked before any analysis. Cognitive function was evaluated as a z-normalized summary score capturing five unique cognitive domains. Linear regression was used to determine the relationship between cognitive function and Internet searches by controlling for variables such as age, sex, and education. Results Over a 6-month monitoring period, 42 participants (mean age 81 years [SD 10.5], 83% [35/42] female) conducted 2915 searches using these top search engines. Participants averaged 3.08 words per search (SD 1.6) and 5.77 letters per word (SD 2.2). Individuals with higher cognitive function used more unique terms per search (beta=.39, P=.002) and employed less common terms in their searches (beta=1.39, P=.02). Cognitive function was not significantly associated with the length of the words used in the searches. Conclusions These results suggest that early decline in cognitive function may be detected from the terms people search for when they use the Internet. By continuously tracking basic aspects of Internet search terms, it may be possible to detect cognitive decline earlier than currently possible, thereby enabling proactive treatment and intervention. PMID:28877864

Data fraud in clinical trials

PubMed Central

George, Stephen L; Buyse, Marc

2015-01-01

Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality. PMID:25729561

Cerebral monitoring devices: what we pay for.

PubMed

Bonhomme, V; Hans, P

2006-01-01

In this review paper, the authors analyse advantages, pitfalls and economical considerations related to depth of anaesthesia monitoring. They first describe the most widely distributed monitors in Europe, and the physiological basis of each index. The optimal use of those monitors and their demonstrated clinical benefits are detailed, as well as the circumstances that can lead to erroneous information or interpretation. Knowledge of patients and practitioners, as well as beliefs and expectations regarding depth of anaesthesia monitoring are discussed. Finally, the authors give their own opinion regarding the use of depth of anaesthesia monitoring, according to clinical benefit and economical considerations.

Biochemical changes related to hypoxia during cerebral aneurysm surgery: combined microdialysis and tissue oxygen monitoring: case report.

PubMed

Hutchinson, P J; Al-Rawi, P G; O'Connell, M T; Gupta, A K; Pickard, J D; Kirkpatrick, P J

2000-01-01

The objective of this study was to monitor brain metabolism on-line during aneurysm surgery, by combining the use of a multiparameter (brain tissue oxygen, brain carbon dioxide, pH, and temperature) sensor with microdialysis (extracellular glucose, lactate, pyruvate, and glutamate). The case illustrates the potential value of these techniques by demonstrating the effects of adverse physiological events on brain metabolism and the ability to assist in both intraoperative and postoperative decision-making. A 41-year-old woman presented with a World Federation of Neurological Surgeons Grade I subarachnoid hemorrhage. Angiography revealed a basilar artery aneurysm that was not amenable to coiling, so the aneurysm was clipped. Before the craniotomy was performed, a multiparameter sensor and a microdialysis catheter were inserted to monitor brain metabolism. During the operation, the brain oxygen level decreased, in relation to biochemical changes, including the reduction of extracellular glucose and pyruvate and the elevation of lactate and glutamate. These changes were reversible. However, when the craniotomy was closed, a second decrease in brain oxygen occurred in association with brain swelling, which immediately prompted a postoperative computed tomographic scan. The scan demonstrated acute hydrocephalus, requiring external ventricular drainage. The patient made a full recovery. The monitoring techniques influenced clinical decision-making in the treatment of this patient. On-line measurement of brain tissue gases and extracellular chemistry has the potential to assist in the perioperative and postoperative management of patients undergoing complex cerebrovascular surgery and to establish the effects of intervention on brain homeostasis.

Pollution monitoring of puget sound with honey bees.

PubMed

Bromenshenk, J J; Carlson, S R; Simpson, J C; Thomas, J M

1985-02-08

To show that honey bees are effective biological monitors of environmental contaminants over large geographic areas, beekeepers of Puget Sound, Washington, collected pollen and bees for chemical analysis. From these data, kriging maps of arsenic, cadmium, and fluoride were generated. Results, based on actual concentrations of contaminants in bee tissues, show that the greatest concentrations of contaminants occur close to Commencement Bay and that honey bees are effective as large-scale monitors.

Towards Precision Addiction Treatment: New Findings in Co-morbid Substance Use and Attention-Deficit Hyperactivity Disorders.

PubMed

Luo, Sean X; Levin, Frances R

2017-03-01

Attention-deficit hyperactivity disorder (ADHD) and substance use disorders (SUDs) may have common etiologies. ADHD is more prevalent in patients with substance use disorders, and this pattern is consistent across different substances of abuse. Individuals with SUDs and ADHD exhibit significant variations in their clinical presentations. The developmental trajectory of ADHD to SUDs is complex: ADHD symptoms appear first in some patients but not in others. Many patients present with a heterogeneous collection of psychiatric and substance use co-morbidities, and these symptoms change over time. ADHD symptom severity is also highly variable, and more severe ADHD symptoms worsen co-morbid SUDs and complicate treatment. New longitudinal studies with innovative methods in high-risk populations and in community-based samples may clarify issues related to patient-treatment matching. When closely monitored, psychostimulant and other adjunct medications can be safely used to treat ADHD in this population, and such treatment may also improve outcome of SUDs. In particular, emerging evidence suggests individual-level tailoring ("precision medicine") approaches may represent a key pathway to improve clinical outcome.

[Hypopituitarism mode in patients with craniopharyngioma in relation to tumor growth pattern].

PubMed

Qi, S T; Peng, J X; Pan, J; Fan, J; Zhang, S C; Liu, Y; Bao, Y; Qiu, B H; Wu, X Y

2018-01-02

Objective: To investigate the pituitary hormone changes of patients with craniopharyngioma of different growth patterns during perioperative period and follow up time. Methods: Retrospective studies were performed on 212 cases of primary craniopharyngioma patient who received total tumor excision surgery in our hospital from January 2001 to May 2012. The characteristics of pituitary hormone and associated clinical manifestation during preoperative, perioperative and postoperative periods were analyzed according to the QST surgical classification. Results: One hundred and seventy-seven (83.5%) of patients present preoperative hypopituitarism, 36 of them were panhypopituitarism. The hypopituitarism condition was exacerbated during the early stage of post-operation period. The abnormal rates of HPA and HPT during the follow up were 60.1% and 58.3% respectively and hormone replacement treatment was needed for these patients. Craniopharyngioma of different growth patterns showed diversities in the characteristics of hypopituitarism. Conclusion: QST surgical classification was closely associated with the pattern of hypopituitarism, it can help to optimize treatment and prognosis estimation, and could be important criterion for improving the clinical practice of neuroendocrine monitoring, treatment and health education of patients with craniopharyngioma.

Electronic health record impact on productivity and efficiency in an academic pediatric ophthalmology practice.

PubMed

Redd, Travis K; Read-Brown, Sarah; Choi, Dongseok; Yackel, Thomas R; Tu, Daniel C; Chiang, Michael F

2014-12-01

To measure the effect of electronic health record (EHR) implementation on productivity and efficiency in the pediatric ophthalmology division at an academic medical center. Four established providers were selected from the pediatric ophthalmology division at the Oregon Health & Science University Casey Eye Institute. Clinical volume was compared before and after EHR implementation for each provider. Time elapsed from chart open to completion (OTC time) and the proportion of charts completed during business hours were monitored for 3 years following implementation. Overall there was an 11% decrease in clinical volume following EHR implementation, which was not statistically significant (P = 0.18). The mean OTC time ranged from 5.5 to 28.3 hours among providers in this study, and trends over time were variable among the four providers. Forty-four percent of all charts were closed outside normal business hours (30% on weekdays, 14% on weekends). EHR implementation was associated with a negative impact on productivity and efficiency in our pediatric ophthalmology division. Copyright © 2014 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

Towards Precision Addiction Treatment: New Findings in Co-morbid Substance Use and Attention-Deficit Hyperactivity Disorders

PubMed Central

Levin, Frances R.

2017-01-01

Attention-deficit hyperactivity disorder (ADHD) and substance use disorders (SUDs) may have common etiologies. ADHD is more prevalent in patients with substance use disorders, and this pattern is consistent across different substances of abuse. Individuals with SUDs and ADHD exhibit significant variations in their clinical presentations. The developmental trajectory of ADHD to SUDs is complex: ADHD symptoms appear first in some patients but not in others. Many patients present with a heterogeneous collection of psychiatric and substance use co-morbidities, and these symptoms change over time. ADHD symptom severity is also highly variable, and more severe ADHD symptoms worsen co-morbid SUDs and complicate treatment. New longitudinal studies with innovative methods in high-risk populations and in community-based samples may clarify issues related to patient-treatment matching. When closely monitored, psychostimulant and other adjunct medications can be safely used to treat ADHD in this population, and such treatment may also improve outcome of SUDs. In particular, emerging evidence suggests individual-level tailoring (“precision medicine”) approaches may represent a key pathway to improve clinical outcome. PMID:28251590

May selective serotonin reuptake inhibitors (SSRIs) provide some benefit for the treatment of schizophrenia?

PubMed

Buoli, Massimiliano; Serati, Marta; Ciappolino, Valentina; Altamura, A Carlo

2016-07-01

The treatment of some psychopathological dimensions of schizophrenia (e.g. negative and depressive symptoms) is still challenging for the modest efficacy of atypical antipsychotics. Among pharmacological alternatives, augmentative Selective Serotonin Reuptake Inhibitors (SSRIs) to antipsychotics are frequently prescribed in clinical practice to improve negative/depressive symptoms of schizophrenia patients; however, the data about the efficacy of these molecules on negative, depressive and obsessive-compulsive symptoms of schizophrenia are contrasting. Research using the main database sources has been conducted to obtain an overview of the use and efficacy of SSRIs in schizophrenia. Data are too scanty to draw definitive recommendations. In a preliminary way, it can be said that available data do not show effectiveness of SSRIs on depressive symptoms of schizophrenia. Regarding negative symptoms, studies are contrasting, but paroxetine appears to be the most effective compound among SSRIs. Despite limited data, SSRIs appear to be useful for the treatment of obsessive-compulsive symptoms of schizophrenia, particularly fluvoxamine. Close clinical and pharmacological monitoring is needed in case of concomitant administration of antipsychotics and antidepressants for potential serious side effects and influence on plasma drug dosages.

[Balneotherapy in the treatment of subjective symptoms of lumbar syndrome].

PubMed

Batsialou, Ioanna

2002-01-01

Chronic low back pain is a degenerative rheumatic disease and is characterized by various symptoms and clinical signs. Balneotherapy represents a therapy by various hot or warm baths in natural mineral waters of specific physical and chemical characteristics. When used externally, they have mechanical, chemical and thermic effects. Balneotherapy of lumbar syndrome includes: individual baths, swimming in the pool, hydrokinesitherapy, underwater massage, underwater extension, mud therapy, mud baths. The therapy should be closely monitored for optimal efficacy and it is necessary to examine: functional status of the lumbosacral region, general functional status (level of activity), lower extremities, pain measurement, use of non-steroid antirheumatic and analgesic agents. In order to follow-up the effects of therapy and establish the prognosis it is important to perform: detailed anamnesis, anthropometric measurements, socio-epidemiological research, clinical examinations. Lumbar syndrome is usually caused by a degenerative disease of the spinal column. More than 25% of people under 45 years of age are unable to work due to chronic low back pain. That is why preventive measures, prompt diagnosis and adequate therapy are of utmost importance.

Apparatus for the Calibration/Certification of Direct Reading Tritium in Air Monitors

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

Otlet, R.L.; Mather, I.D.; Pottinger, M

2005-07-15

Direct reading tritium-in-air-monitors are widely used for immediate observation of discharges or working area levels where significant sources of tritium are held. These monitors require initial and periodic calibration certification at the levels likely to be encountered. We describe a purpose built gas handling apparatus which enables various activity levels of tritiated gas ({sup 3}H + N{sub 2}) to be precisely metered and circulated in a closed loop through the monitor under calibration at a wide range of activity levels.

Cycle 24 COS FUV Internal/External Wavelength Scale Monitor

NASA Astrophysics Data System (ADS)

Fischer, William J.

2018-02-01

We report on the monitoring of the COS FUV wavelength scale zero-points during Cycle 24 in program 14855. Select cenwaves were monitored for all FUV gratings at Lifetime Position 3. The target and cenwaves have remained the same since Cycle 21, with a change only to the target acquisition sequence. All measured offsets are within the error goals, although the G140L cenwaves show offsets at the short-wavelength end of segment A that are approaching the tolerance. This behavior will be closely monitored in subsequent iterations of the program.

Estimation of Groundwater Storage Change via GRACE over a Small Watershed - A Case Study over Konya Closed Basin

NASA Astrophysics Data System (ADS)

Karasu, İ. G.; Yilmaz, K. K.; Yilmaz, M. T.

2017-12-01

Estimation of the groundwater storage change and its interannual variability is critical over Konya Closed Basin which has excessive agricultural production. The annual total precipitation falling over the region is not sufficient to compensate the agricultural irrigation needs of the region. This leds many to use groundwater as the primary water resource, which resulted in significant drop in the groundwater levels. Accordingly, monitoring of the groundwater change is critical for sustainable water resources management. Gravity Recovery and Climate Experiment (GRACE) observations and Global Land Data Assimilation System (GLDAS) have been succesfully used over many locations to monitor the change in the groundwater storages. In this study, GRACE-derived terrestrial water storage estimates and GLDAS model soil moisture, canopy water, snow water equivalent and surface runoff simulations are used to retrieve the change in the groundwater storage over Konya Closed Basin streching over 50,000 km2 area. Initial comparisons show the declining trend in GRACE and GLDAS combined groundwater storage change estimates between 2002 and 2016 are consistent with the actual groundwater level change observed at ground stations. Even though many studies recommend GRACE observations to be used over regions larger than 100,000 km2 - 200,000 km2 area, results show GRACE remote sensing and GLDAS modeled groundwater change information are skillful to monitor the large mass changes occured as a result of the excessive groundwater exploitation over Konya Closed Basin with 50,000 km2 area.

Prevalence and clinical outcomes of hepatitis B virus infection in patients with aplastic anemia.

PubMed

Zhao, Pan; Gao, Qing; He, Qiulian; Tan, Jing

2017-10-01

The association of HBV infection with other hematopoietic diseases has been discussed previously. However, the clinical significance and clinical outcomes of HBV infection in AA patients have not been clarified. In this study, we sought to investigate the prevalence and related events of HBV in patients with AA who received immunosuppressive therapy. We retrospectively analyzed 245 patients with acquired AA. The HBsAg positivity rate was 14.69% in this group of AA patients. No significant difference was observed in the severity of AA patients with HBV infection and in those without (P = 0.6358). HBV reactivation occurred in 4.76% of HBsAg-positive patients who received ATG/ALG + CsA treatment without anti-viral prophylaxis. HBV-infected patients who received CsA alone did not develop reactivation. Patients with HBV reactivation showed favorable clinical outcomes, with no HBV-related deaths. There was no significant difference in overall probability of survival in patients with different HBV infection status (P = 0.8617). Given the low rate of reactivation and favorable outcomes after reactivation in AA patients, close monitoring of HBV DNA, hepatic function and patient immune status may be a more effective approach than routine prophylaxis for AA patients with HBV infection undergoing ATG/ALG + CsA treatment. Further studies are warranted to clarify the optimal time to initiate anti-viral treatment.

Radioimmunotherapy for non-Hodgkin's lymphoma: A review for radiation oncologists

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

Macklis, Roger M.; Pohlman, Brad

Purpose: The aim of this study was to review advances in radioimmunotherapy (RIT) for non-Hodgkin's lymphoma (NHL) and to discuss the role of Radiation oncologist in administering this important new form of biologically targeted radiotherapy. Methods and Materials: A review of articles and abstracts on the clinical efficacy, safety, and radiation safety of yttrium Y 90 ({sup 9}Y) ibritumomab tiuxetan (Zevalin) and iodine I 131 tositumomab (Bexxar) was performed. Results: The clinical efficacy of RIT in NHL has been shown in numerous clinical trials of {sup 9}Y ibritumomab tiuxetan and {sup 131}I tositumomab. Both agents have produced significant responses inmore » patients with low-grade, follicular, or transformed NHL, including patients with disease that had not responded or had responded poorly to previous chemotherapy or immunotherapy. Reversible toxicities such as neutropenia, thrombocytopenia, and anemia are the most common adverse events with both agents. Conclusions: Radioimmunotherapy is safe and effective in many patients with B-cell NHL. {sup 9}Y ibritumomab tiuxetan and {sup 131}I tositumomab can produce clinically meaningful and durable responses even in patients in whom chemotherapy has failed. Treatment with RIT requires a multispecialty approach and close communication between Radiation oncologist and other members of the treatment team. Radiation oncologist plays an important role in treating patients with RIT and monitoring them for responses and adverse events after treatment.« less

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.

Does Familism Lead to Increased Parental Monitoring?: Protective Factors for Coping with Risky Behaviors

ERIC Educational Resources Information Center

Romero, Andrea J.; Ruiz, Myrna

2007-01-01

We examined coping with risky behaviors (cigarettes, alcohol/drugs, yelling/ hitting, and anger), familism (family proximity and parental closeness) and parental monitoring (knowledge and discipline) in a sample of 56 adolescents (11-15 years old) predominantly of Mexican descent at two time points. Multiple linear regression analysis indicated…

40 CFR 63.653 - Monitoring, recordkeeping, and implementation plan for emissions averaging.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) For each emission point included in an emissions average, the owner or operator shall perform testing, monitoring, recordkeeping, and reporting equivalent to that required for Group 1 emission points complying... internal floating roof, external roof, or a closed vent system with a control device, as appropriate to the...

An improved method for collecting and monitoring pine oleoresin

Treesearch

Dick Karsky; Brian Strom; Harold Thistle

2004-01-01

A new method for collecting and monitoring pine oleoresin has been developed through a cooperative project involving the Missoula Technology Development Center (MTDC), Southern Research Station (Brian Strom, research entomologist), and the Forest Health Technology Enterprise Team. The new sampling unit (figure 1) is cast from rugged plastic. It provides a closed system...

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

Self-monitoring of blood glucose in diabetes mellitus: arguments for an individualized approach.

PubMed

Nauck, Michael A; El-Ouaghlidi, Andrea; Vardarli, Irfan

2009-09-01

The utility of glucose self-monitoring in different types and stages of diabetes is controversial, as there is only sparse relevant evidence from randomized controlled clinical trials. In this analysis, the authors aim to develop individualized recommendations based on clinical needs and the available literature. The PubMed database was searched for articles that appeared up to 30 September 2008 containing the terms "measurement," "control","monitoring," and "hypoglycemia"; the retrieved articles were supplemented by other articles that were cited in them. A directed search was also made for the recommendations of the German, European, American, and international diabetological societies. Conclusions were then drawn about the useful modalities and extent of glucose self-monitoring on the basis of the clinical features of the major types of diabetes and the main treatment strategies for them. With the exception of intensified treatment strategies (which rely on blood-sugar regulation with insulin), only a few evidence-based recommendations can be derived from randomized clinical trials and meta-analyses. Nonetheless, a strategy for self-monitoring according to the patient's individual needs can be derived from the characteristics of therapeutic regimens: depending on the type of diabetes from which the patient suffers, the predicted number of glucometer strips required for self-monitoring will vary from almost none to roughly 400 per month. The decision to use glucose self-monitoring, as well as the type and extent of self-monitoring that will be used, should be based on the individual patient's type of diabetes, treatment regimen, and clinical characteristics. Like any other type of therapeutic intervention, self-monitoring should have a well-documented, rational justification.

Ultrasound monitoring of inter-knee distances during gait.

PubMed

Lai, Daniel T H; Wrigley, Tim V; Palaniswami, M

2009-01-01

Knee osteoarthritis is an extremely common, debilitating disease associated with pain and loss of function. There is considerable interest in monitoring lower limb alignment due to its close association with joint overload leading to disease progression. The effects of gait modifications that can lower joint loading are of particular interest. Here we describe an ultrasound-based system for monitoring an important aspect of dynamic lower limb alignment, the inter-knee distance during walking. Monitoring this gait parameter should facilitate studies in reducing knee loading, a primary risk factor of knee osteoarthritis progression. The portable device is composed of an ultrasound sensor connected to an Intel iMote2 equipped with Bluetooth wireless capability. Static tests and calibration results show that the sensor possesses an effective beam envelope of 120 degrees, with maximum distance errors of 10% at the envelope edges. Dynamic walking trials reveal close correlation of inter-knee distance trends between that measured by an optical system (Optotrak Certus NDI) and the sensor device. The maximum average root mean square error was found to be 1.46 cm. Future work will focus on improving the accuracy of the device.

What's to Be Done About Laboratory Quality? Process Indicators, Laboratory Stewardship, the Outcomes Problem, Risk Assessment, and Economic Value: Responding to Contemporary Global Challenges.

PubMed

Meier, Frederick A; Badrick, Tony C; Sikaris, Kenneth A

2018-02-17

For 50 years, structure, process, and outcomes measures have assessed health care quality. For clinical laboratories, structural quality has generally been assessed by inspection. For assessing process, quality indicators (QIs), statistical monitors of steps in the clinical laboratory total testing, have proliferated across the globe. Connections between structural and process laboratory measures and patient outcomes, however, have rarely been demonstrated. To inform further development of clinical laboratory quality systems, we conducted a selective but worldwide review of publications on clinical laboratory quality assessment. Some QIs, like seven generic College of American Pathologists Q-Tracks monitors, have demonstrated significant process improvement; other measures have uncovered critical opportunities to improve test selection and result management. The College of Pathologists of Australasia Key Indicator Monitoring and Management System has deployed risk calculations, introduced from failure mode effects analysis, as surrogate measures for outcomes. Showing economic value from clinical laboratory testing quality is a challenge. Clinical laboratories should converge on fewer (7-14) rather than more (21-35) process monitors; monitors should cover all steps of the testing process under laboratory control and include especially high-risk specimen-quality QIs. Clinical laboratory stewardship, the combination of education interventions among clinician test orderers and report consumers with revision of test order formats and result reporting schemes, improves test ordering, but improving result reception is more difficult. Risk calculation reorders the importance of quality monitors by balancing three probabilities: defect frequency, weight of potential harm, and detection difficulty. The triple approach of (1) a more focused suite of generic consensus quality indicators, (2) more active clinical laboratory testing stewardship, and (3) integration of formal risk assessment, rather than competing with economic value, enhances it.

Closed-Tube Barcoding.

PubMed

Sirianni, Nicky M; Yuan, Huijun; Rice, John E; Kaufman, Ronit S; Deng, John; Fulton, Chandler; Wangh, Lawrence J

2016-11-01

Here, we present a new approach for increasing the rate and lowering the cost of identifying, cataloging, and monitoring global biodiversity. These advances, which we call Closed-Tube Barcoding, are one application of a suite of proven PCR-based technologies invented in our laboratory. Closed-Tube Barcoding builds on and aims to enhance the profoundly important efforts of the International Barcode of Life initiative. Closed-Tube Barcoding promises to be particularly useful when large numbers of small or rare specimens need to be screened and characterized at an affordable price. This approach is also well suited for automation and for use in portable devices.

On the front line of HIV virological monitoring: barriers and facilitators from a provider perspective in resource-limited settings.

PubMed

Rutstein, S E; Golin, C E; Wheeler, S B; Kamwendo, D; Hosseinipour, M C; Weinberger, M; Miller, W C; Biddle, A K; Soko, A; Mkandawire, M; Mwenda, R; Sarr, A; Gupta, S; Mataya, R

2016-01-01

Scale-up of viral load (VL) monitoring for HIV-infected patients on antiretroviral therapy (ART) is a priority in many resource-limited settings, and ART providers are critical to effective program implementation. We explored provider-perceived barriers and facilitators of VL monitoring. We interviewed all providers (n = 17) engaged in a public health evaluation of dried blood spots for VL monitoring at five ART clinics in Malawi. All ART clinics were housed within district hospitals. We grouped themes at patient, provider, facility, system, and policy levels. Providers emphasized their desire for improved ART monitoring strategies, and frustration in response to restrictive policies for determining which patients were eligible to receive VL monitoring. Although many providers pled for expansion of monitoring to include all persons on ART, regardless of time on ART, the most salient provider-perceived barrier to VL monitoring implementation was the pressure of work associated with monitoring activities. The work burden was exacerbated by inefficient data management systems, highlighting a critical interaction between provider-, facility-, and system-level factors. Lack of integration between laboratory and clinical systems complicated the process for alerting providers when results were available, and these communication gaps were intensified by poor facility connectivity. Centralized second-line ART distribution was also noted as a barrier: providers reported that the time and expenses required for patients to collect second-line ART frequently obstructed referral. However, provider empowerment emerged as an unexpected facilitator of VL monitoring. For many providers, this was the first time they used an objective marker of ART response to guide clinical management. Providers' knowledge of a patient's virological status increased confidence in adherence counseling and clinical decision-making. Results from our study provide unique insight into provider perceptions of VL monitoring and indicate the importance of policies responsive to individual and environmental challenges of VL monitoring program implementation. Findings may inform scale-up by helping policy-makers identify strategies to improve feasibility and sustainability of VL monitoring.

Opioid addiction and misuse in adult and adolescent patients with cancer.

PubMed

Pinkerton, Ross; Hardy, Janet R

2017-06-01

In the context of a therapeutic opioid epidemic, particularly in the USA, where increasingly stringent screening for 'at risk' individuals and close monitoring of opioid prescription and use is strongly recommended, the issue of misuse within the cancer population must be addressed. Most patients with advanced cancer will have pain requiring opioid therapy at some stage during their disease course. In the majority, this will provide good pain relief with no short- or longer-term adverse sequelae. A subset will present with substance misuse issues that will influence management and prescribing practice. The potential ethical issues of limiting effective analgesia on the basis of addiction risk or history must be acknowledged. Both a judgemental or 'relaxed' approach to such patients is problematic. Ignoring the situation will not be in the patient's best interest, but an undue focus on this aspect may damage therapeutic relationships with clinicians and adversely affect a holistic approach to care. Clinical practitioners must be aware of the risk factors for opioid misuse and in patients who are not under palliative care consider screening prior to commencing opioids. Clinicians must be able to manage and monitor those identified as having an opioid misuse problem. © 2017 Royal Australasian College of Physicians.

A method for monitoring of oxygen saturation changes in brain tissue using diffuse reflectance spectroscopy.

PubMed

Rejmstad, Peter; Johansson, Johannes D; Haj-Hosseini, Neda; Wårdell, Karin

2017-03-01

Continuous measurement of local brain oxygen saturation (SO 2 ) can be used to monitor the status of brain trauma patients in the neurocritical care unit. Currently, micro-oxygen-electrodes are considered as the "gold standard" in measuring cerebral oxygen pressure (pO 2 ), which is closely related to SO 2 through the oxygen dissociation curve (ODC) of hemoglobin, but with the drawback of slow in response time. The present study suggests estimation of SO 2 in brain tissue using diffuse reflectance spectroscopy (DRS) for finding an analytical relation between measured spectra and the SO 2 for different blood concentrations. The P 3 diffusion approximation is used to generate a set of spectra simulating brain tissue for various levels of blood concentrations in order to estimate SO 2 . The algorithm is evaluated on optical phantoms mimicking white brain matter (blood volume of 0.5-2%) where pO 2 and temperature is controlled and on clinical data collected during brain surgery. The suggested method is capable of estimating the blood fraction and oxygen saturation changes from the spectroscopic signal and the hemoglobin absorption profile. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Noninvasive ventilation for patients with acute lung injury or acute respiratory distress syndrome.

PubMed

Nava, Stefano; Schreiber, Ania; Domenighetti, Guido

2011-10-01

Few studies have been performed on noninvasive ventilation (NIV) to treat hypoxic acute respiratory failure in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). The outcomes of these patients, for whom endotracheal intubation is not mandatory, depend on the degree of hypoxia, the presence of comorbidities and complications, and their illness severity. The use of NIV as an alternative to invasive ventilation in severely hypoxemic patients with ARDS (ie, P(aO(2))/F(IO(2)) < 200) is not generally advisable and should be limited to hemodynamically stable patients who can be closely monitored in an intensive care unit by highly skilled staff. Early NIV application may be extremely helpful in immunocompromised patients with pulmonary infiltrates, in whom intubation dramatically increases the risk of infection, pneumonia, and death. The use of NIV in patients with severe acute respiratory syndrome and other airborne diseases has generated debate, despite encouraging clinical results, mainly because of safety issues. Overall, the high rate of NIV failure suggests a cautious approach to NIV use in patients with ALI/ARDS, including early initiation, intensive monitoring, and prompt intubation if signs of NIV failure emerge.

Pancreas allograft biopsies in the management of pancreas transplant recipients: histopathologic review and clinical correlations.

PubMed

Gaber, Lillian W

2007-08-01

Pancreas transplantation has become a therapeutic option for patients with type 1 diabetes mellitus who are in end-stage renal failure. It also is indicated for a subset of nonuremic, insulin-dependent diabetics who experience extreme difficulties in maintaining proper glucose homeostasis by insulin therapy that compromises their productivity and safety. To provide a review of the literature and expert experiences for understanding the histologic findings in pancreas transplantation. The published literature between 1990 and 2005 was reviewed for this report. Additionally, personal files of the author were used, along with biopsy slides that were used for figures. Pancreas transplantation reestablishes the physiologic state of insulin secretion, and pancreas transplant recipients are able to maintain a state of long-term euglycemia and are less likely to be exposed to hyperglycemia and its systemic complications. Key to the success of transplantation is the scrupulous management and close monitoring of the pancreas transplant recipients. To that end, histologic evaluation of pancreas allografts assumed a pivotal role in management of pancreas allograft dysfunction episodes, and in some centers surveillance biopsies are used to monitor immunologically high-risk situations.

Closed-loop for type 1 diabetes - an introduction and appraisal for the generalist.

PubMed

Bally, Lia; Thabit, Hood; Hovorka, Roman

2017-01-23

Rapid progress over the past decade has been made with the development of the 'Artificial Pancreas', also known as the closed-loop system, which emulates the feedback glucose-responsive functionality of the pancreatic beta cell. The recent FDA approval of the first hybrid closed-loop system makes the Artificial Pancreas a realistic therapeutic option for people with type 1 diabetes. In anticipation of its advent into clinical care, we provide a primer and appraisal of this novel therapeutic approach in type 1 diabetes for healthcare professionals and non-specialists in the field. Randomised clinical studies in outpatient and home settings have shown improved glycaemic outcomes, reduced risk of hypoglycaemia and positive user attitudes. User input and interaction with existing closed-loop systems, however, are still required. Therefore, management of user expectations, as well as training and support by healthcare providers are key to ensure optimal uptake, satisfaction and acceptance of the technology. An overview of closed-loop technology and its clinical implications are discussed, complemented by our extensive hands-on experience with closed-loop system use during free daily living. The introduction of the artificial pancreas into clinical practice represents a milestone towards the goal of improving the care of people with type 1 diabetes. There remains a need to understand the impact of user interaction with the technology, and its implication on current diabetes management and care.

Bedside arterial blood gas monitoring system using fluorescent optical sensors

NASA Astrophysics Data System (ADS)

Bartnik, Daniel J.; Rymut, Russell A.

1995-05-01

We describe a bedside arterial blood gas (ABG) monitoring system which uses fluorescent optical sensors in the measurement of blood pH, PCO2 and PO2. The Point-of-Care Arterial Blood Gas Monitoring System consists of the SensiCathTM optical sensor unit manufactured by Optical Sensors Incorporated and the TramTM Critical Care Monitoring System with ABG Module manufactured by Marquette Electronics Incorporated. Current blood gas measurement techniques require a blood sample to be removed from the patient and transported to an electrochemical analyzer for analysis. The ABG system does not require removal of blood from the patient or transport of the sample. The sensor is added to the patient's existing arterial line. ABG measurements are made by drawing a small blood sample from the arterial line in sufficient quantity to ensure an undiluted sample at the sensor. Measurements of pH, PCO2 and PO2 are made within 60 seconds. The blood is then returned to the patient, the line flushed and results appear on the bedside monitor. The ABG system offers several advantages over traditional electrochemical analyzers. Since the arterial line remains closed during the blood sampling procedure the patient's risk of infection is reduced and the caregiver's exposure to blood is eliminated. The single-use, disposable sensor can be measure 100 blood samples over 72 hours after a single two-point calibration. Quality Assurance checks are also available and provide the caregiver the ability to assess system performance even after the sensor is patient attached. The ABG module integrates with an existing bedside monitoring system. This allows ABG results to appear on the same display as ECG, respiration, blood pressure, cardiac output, SpO2, and other clinical information. The small module takes up little space in the crowded intensive care unit. Performance studies compare the ABG system with an electrochemical blood gas analyzer. Study results demonstrated accurate and precise blood gas measurement of 100 samples and 72 hour performance without need for re-calibration.

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...

Metabolic syndrome in young children: definitions and results of the IDEFICS study.

PubMed

Ahrens, W; Moreno, L A; Mårild, S; Molnár, D; Siani, A; De Henauw, S; Böhmann, J; Günther, K; Hadjigeorgiou, C; Iacoviello, L; Lissner, L; Veidebaum, T; Pohlabeln, H; Pigeot, I

2014-09-01

To estimate the prevalence of the metabolic syndrome (MetS) using reference standards obtained in European children and to develop a quantitative MetS score and describe its distribution in children. Population-based survey in eight European countries, including 18745 children 2.0 to 10.9 years, recruited during a second survey. Anthropometry (weight, height and waist circumference), blood pressure and serum-fasting triglycerides, HDL cholesterol, glucose and insulin were measured. We applied three widely accepted definitions of the pediatric MetS and we suggest a new definition, to guide pediatricians in decisions about close monitoring or even intervention (values of at least three of the MetS components exceeding the 90th or 95th percentile, respectively). We used a z-score standardisation to calculate a continuous score combining the MetS components. Among the various definitions of MetS, the highest prevalence (5.5%) was obtained with our new definition requiring close observation (monitoring level). Our more conservative definition, requiring pediatric intervention gives a prevalence of 1.8%. In general, prevalences were higher in girls than in boys. The prevalence of metabolic syndrome is highest among obese children. All definitions classify a small percentage of thin or normal weight children as being affected. The metabolic syndrome score shows a positive trend with age, particularly regarding the upper percentiles of the score. According to different definitions of pediatric MetS, a non-negligible proportion of mostly prepubertal children are classified as affected. We propose a new definition of MetS that should improve clinical guidance. The continuous score developed may also serve as a useful tool in pediatric obesity research. It has to be noted, however, that the proposed cutoffs are based on a statistical definition that does not yet allow to quantify the risk of subsequent disease.

Safety Profile of Oral Iron Chelator Deferiprone in Chinese Children with Transfusion-Dependent Thalassaemia.

PubMed

Botzenhardt, Sebastian; Sing, Chor W; Wong, Ian C K; Chan, Godfrey Chi-Fung; Wong, Lisa Y L; Felisi, Mariagrazia; Rascher, Wolfgang; Ceci, Adriana; Neubert, Antje

2016-01-01

There is a lack of knowledge regarding the incidence of serious adverse drug reactions (ADR) to the oral iron chelator deferiprone in Chinese children with transfusion-dependent thalassaemia. In this retrospective population-based cohort study, paediatric thalassaemia patients in Hong Kong were screened for serious and medically important adverse events related to deferiprone therapy using diagnosis codes, laboratory data and hospital admissions. Potential ADRs were assessed by reviewing concomitant medications, diagnoses and laboratory data and evaluated using standardised causality assessment. Eighty-seven patients contributing 169.8 person-years were included. Thirty ADRs were identified in 21 patients. Most ADRs (56.0%) occurred in the first three months of therapy. Neutropenia occurred in 11 patients (12.6%; incidence rate 6.5 per 100 patient-years) and severe neutropenia (agranulocytosis) was observed in 5 patients (5.7%, incidence rate 2.9 per 100 patient-years). Other identified ADRs involve severe arthropathy, elevated liver enzymes and mild thrombocytopenia. In conclusion, the safety profile of DFP therapy in Chinese children suffering from transfusion-dependent thalassaemia is in line with previous studies of non-Chinese children. However, unlike previous studies, we observed a relatively high incidence of agranulocytosis and neutropenia in patients with simultaneous combined therapy. Hence close monitoring for white blood cell counts is advised in Chinese children under combined iron chelation therapy. Further prospective clinical and pharmacogenetic studies are required to better evaluate this important safety signal. • Half of the identified ADRs related to deferiprone therapy occurred during the first three months of treatment. • A relatively high incidence of agranulocytosis and neutropenia. Hence close monitoring for white blood cell counts is advised in Chinese children under combined iron chelation therapy.

Conservative Management of Colonoscopic Perforation: A Case Report.

PubMed

Parsa, Hossein; Miroliaee, Arash; Doagoo, Zafar; Sina, Saeed

2017-07-01

Colonoscopy is widely used for the diagnosis, treatment and a follow up of colorectal diseases. Perforation of the large bowel during elective colonoscopy is rare but serious life threatening complication. We report a 51-year-old woman who experienced recto sigmoid perforation during diagnostic colonoscopy. During 8 days of total hospitalization, she spent 3 days in ICU with gastrointestinal rest. The patient was hydrated and took intravenous antibiotics. In take-output and temperature were closely monitored. Serial abdominal examinations were performed to rule out peritonitis. After transferring to surgery ward in the day 4, liquid diet started slowly, and she was ambulated. At the day 8, she was discharged with the good clinical condition. Conservative management of the patients with early diagnosis of perforation and no signs and symptoms of peritonitis or sepsis could be the modality of choice.

Indicators for surgery in adhesive bowel obstruction.

PubMed

Rajanikmanth, P V; Kate, V; Ananthakrishnan, N

2001-01-01

There is lack of data on risk factors, which, if present, would indicate the need for surgery in patients with adhesive bowel obstruction. A Cohort of 100 consecutive patients with adhesive obstruction was studied prospectively to compare clinical and investigative parameters between the operative and conservative group. It was found that female gender, previous obstetric or gynaecological procedures, pulse and BP on admission, nature of nasogastric aspirate, single distended loop on abdominal x-ray as also predominant ileal distension were independent factors indicating a high probability of surgical intervention. Patients with 2 or more risk factors had 12 times higher probability of surgery and in those with 3 or more the relative risk was 30 times. Patients with such risk factors should be monitored closely after admission and should be taken for surgery after an initial short trial of conservative measures.

Wireless Sensor Networks for Ambient Assisted Living

PubMed Central

Aquino-Santos, Raúl; Martinez-Castro, Diego; Edwards-Block, Arthur; Murillo-Piedrahita, Andrés Felipe

2013-01-01

This paper introduces wireless sensor networks for Ambient Assisted Living as a proof of concept. Our workgroup has developed an arrhythmia detection algorithm that we evaluate in a closed space using a wireless sensor network to relay the information collected to where the information can be registered, monitored and analyzed to support medical decisions by healthcare providers. The prototype we developed is then evaluated using the TelosB platform. The proposed architecture considers very specific restrictions regarding the use of wireless sensor networks in clinical situations. The seamless integration of the system architecture enables both mobile node and network configuration, thus providing the versatile and robust characteristics necessary for real-time applications in medical situations. Likewise, this system architecture efficiently permits the different components of our proposed platform to interact efficiently within the parameters of this study. PMID:24351665

Commensal or pathogen – a challenge to fulfil Koch’s Postulates

PubMed Central

Hess, M.

2017-01-01

ABSTRACT 1. Infectious diseases have a large impact on poultry health and economics. Elucidating the pathogenesis of a certain disease is crucial to implement control strategies. 2. Multiplication of a pathogen and its characterisation in vitro are basic requirements to perform experimental studies. However, passaging of the pathogen in vitro can influence the pathogenicity, a process targeted for live vaccine development, but limits the reproduction of clinical signs. 3. Numerous factors can influence the outcome of experimental infections with some importance on the pathogen, application route and host as exemplarily outlined for Histomonas meleagridis, Gallibacterium anatis and fowl aviadenoviruses (FAdVs). 4. In future, more comprehensive and detailed settings are needed to obtain as much information as possible from animal experiments. Processing of samples with modern diagnostic tools provides the option to closely monitor the host–pathogen interaction. PMID:27724044

Guidelines for specialized nutritional and metabolic support in the critically-ill patient: update. Consensus SEMICYUC-SENPE: neurocritical patient.

PubMed

Acosta Escribano, J; Herrero Meseguer, I; Conejero García-Quijada, R

2011-11-01

Neurocritical patients require specialized nutritional support due to their intense catabolism and prolonged fasting. The preferred route of nutrient administration is the gastrointestinal route, especially the gastric route. Alternatives are the transpyloric route or mixed enteral-parenteral nutrition if an effective nutritional volume of more than 60% cannot be obtained. Total calorie intake ranges from 20-30 kcal/kg/day, depending on the period of the clinical course, with protein intake higher than 20% of total calories (hyperproteic diet). Nutritional support should be initiated early. The incidence of gastrointestinal complications is generally higher to other critically-ill patients, the most frequent complication being an increase in gastric residual volume. As in other critically-ill patients, glycemia should be closely monitored and maintained below 150 mg/dL.

CHOROIDAL MELANOMA IN A PATIENT WITH WAARDENBURG SYNDROME.

PubMed

Itty, Sujit; Richter, Elizabeth R; McCannel, Tara A

2015-01-01

To report a case of choroidal malignant melanoma in a patient with Waardenburg syndrome and bilateral choroidal pigmentary abnormalities. Clinical examination and multimodal imaging of the case. A 45-year-old woman presented with asymptomatic flat choroidal pigmentation abnormalities in both eyes. A choroidal lesion was identified in the inferotemporal periphery of the left eye arising from an area of hyperpigmentation; ultrasonography findings were consistent with a choroidal melanoma. The patient endorsed a personal and family history of premature graying of hair and was identified to have dystopia canthorum consistent with the diagnosis of Waardenburg syndrome. The authors present the first reported case of concurrent Waardenburg syndrome and choroidal malignant melanoma. This cooccurrence may suggest that the relative hyperpigmented regions in affected fundi may be abnormal and should be monitored closely for the development of choroidal melanoma.

Ring-Closing Metathesis: An Advanced Guided-Inquiry Experiment for the Organic Laboratory

ERIC Educational Resources Information Center

Schepmann, Hala G.; Mynderse, Michelle

2010-01-01

The design and implementation of an advanced guided-inquiry experiment for the organic laboratory is described. Grubbs's second-generation catalyst is used to effect the ring-closing metathesis of diethyl diallylmalonate. The reaction is carried out under an inert atmosphere at room temperature and monitored by argentic TLC. The crude reaction is…

40 CFR Table 8 to Subpart Eeee of... - Continuous Compliance With Emission Limits

Code of Federal Regulations, 2010 CFR

2010-07-01

..., items 1 through 6 a. Reduce total organic HAP (or, upon approval, TOC) emissions from the closed vent... organic HAP (or, upon approval, TOC) in the exhaust of combustion devices i. Performing CMS monitoring and... HAP (or, upon approval, TOC) emissions during the loading of organic liquids from the closed vent...

Parenting Practices as Moderators of the Relationship between Peers and Adolescent Marijuana Use

ERIC Educational Resources Information Center

Dorius, Cassandra J.; Bahr, Stephen J.; Hoffmann, John P.; Harmon, Elizabeth Lovelady

2004-01-01

Using data from a probability sample of 4,987 adolescents, we examine the degree to which closeness to mother, closeness to father, parental support, and parental monitoring buffer the relationship between peer drug use and adolescent marijuana use. The relationship between peer drug use and adolescent marijuana use was attenuated by both…

Development of near real time performance measurements for closed-loop signal systems (CLS) using historical traffic data from existing loop detectors and signal timing data.

DOT National Transportation Integrated Search

2014-10-01

The overarching goal of this research project was to investigate the potential for the NCDOT Central Office Signal Timing : (COST) Section to monitor and assess the quality of field deployed closed-loop signal system plans using the data inherent in ...

Precision closed bomb calorimeter for testing flame and gas producing initiators

NASA Technical Reports Server (NTRS)

Carpenter, D. R., Jr.; Taylor, A. C., Jr.

1972-01-01

A calorimeter has been developed under this study to help meet the needs of accurate performance monitoring of electrically or mechanically actuated flame and gas producing devices, such as squib-type initiators. A ten cubic centimeter closed bomb (closed volume) calorimeter was designed to provide a standard pressure trace and to measure a nominal 50 calorie output, using the basic components of a Parr Model 1411 calorimeter. Two prototype bombs were fabricated, pressure tested to 2600 psi, and extensively evaluated.

[Closed-loop management model of clinical investigational product for new drug of traditional Chinese medicine].

PubMed

Wu, Ping; Zhang, Jian-Wu

2013-09-01

This paper discussed the management regulations and technical requirements of clinical investigational product for new drug of traditional Chinese medicine, analyzed some common problems on the management of them, and proposed the establishment of closed-loop management model and management requirements in various aspects.

75 FR 1796 - National Center for Complementary and Alternative Medicine; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-13

... Complementary and Alternative Medicine; Notice of Closed Meetings Pursuant to section 10(d) of the Federal... Alternative Medicine Special Emphasis Panel, Clinical Science-- Review of NCCAM Clinical R21 and K..., National Center for Complementary, and Alternative Medicine, NIH, 6707 Democracy Blvd., Suite 401, Bethesda...

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.

Investigation of creep by use of closed loop servo-hydraulic test system

NASA Technical Reports Server (NTRS)

Wu, H. C.; Yao, J. C.

1981-01-01

Creep tests were conducted by means of a closed loop servo-controlled materials test system. These tests are different from the conventional creep tests in that the strain history prior to creep may be carefully monitored. Tests were performed for aluminum alloy 6061-0 at 150 C and monitored by a PDP 11/04 minicomputer at a preset constant plastic-strain rate prehistory. The results show that the plastic-strain rate prior to creep plays a significant role in creep behavior. The endochronic theory of viscoplasticity was applied to describe the observed creep curves. The concepts of intrinsic time and strain rate sensitivity function are employed and modified according to the present observation.

Telemetric implantable pressure sensor for short- and long-term monitoring of intracranial pressure.

PubMed

Frischholz, M; Sarmento, L; Wenzel, M; Aquilina, K; Edwards, R; Coakham, H B

2007-01-01

Patients with hydrocephalus, idiopathic intracranial hypertension and head injury frequently require monitoring of intracranial pressure (ICP) and may need repeated episodes of monitoring months or years apart. The gold standard for measurement of ICP remains the external ventricular catheter. This is a fluid-filled catheter transducer system that allows regular recalibration and correction of zero drift by its position relative to a fixed anatomical reference. It also allows drainage of cerebrospinal fluid (CSF), providing a means of lowering the ICP. Several catheter tip transducer systems are currently in clinical use, including using strain gauges or fiber-optical pressure sensing techniques. In these devices, zero drift and calibration cannot be checked in vivo. All the ICP monitoring devices in current clinical use require a physical connection between the brain and the external environment. This is a source of infection and limits the duration of monitoring. A number of telemetric monitoring devices, in which data is in some way transmitted transcutaneously, have been developed over the last twenty years, but significant technical problems have precluded their use in routine clinical practice. All current ICP monitors are temporary percutaneous implanted devices. Placement of these devices carries significant morbidity, particularly infection. Patients undergoing repeated monitoring require multiple surgical procedures. Apart from decreasing the risk of infection in patients with severe head injury, the clinical value of an accurate telemetric ICP monitoring system which maintains its reliability over a long period of implantation is high.

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.

Electronic self-monitoring of mood using IT platforms in adult patients with bipolar disorder: A systematic review of the validity and evidence.

PubMed

Faurholt-Jepsen, Maria; Munkholm, Klaus; Frost, Mads; Bardram, Jakob E; Kessing, Lars Vedel

2016-01-15

Various paper-based mood charting instruments are used in the monitoring of symptoms in bipolar disorder. During recent years an increasing number of electronic self-monitoring tools have been developed. The objectives of this systematic review were 1) to evaluate the validity of electronic self-monitoring tools as a method of evaluating mood compared to clinical rating scales for depression and mania and 2) to investigate the effect of electronic self-monitoring tools on clinically relevant outcomes in bipolar disorder. A systematic review of the scientific literature, reported according to the Preferred Reporting items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines was conducted. MEDLINE, Embase, PsycINFO and The Cochrane Library were searched and supplemented by hand search of reference lists. Databases were searched for 1) studies on electronic self-monitoring tools in patients with bipolar disorder reporting on validity of electronically self-reported mood ratings compared to clinical rating scales for depression and mania and 2) randomized controlled trials (RCT) evaluating electronic mood self-monitoring tools in patients with bipolar disorder. A total of 13 published articles were included. Seven articles were RCTs and six were longitudinal studies. Electronic self-monitoring of mood was considered valid compared to clinical rating scales for depression in six out of six studies, and in two out of seven studies compared to clinical rating scales for mania. The included RCTs primarily investigated the effect of heterogeneous electronically delivered interventions; none of the RCTs investigated the sole effect of electronic mood self-monitoring tools. Methodological issues with risk of bias at different levels limited the evidence in the majority of studies. Electronic self-monitoring of mood in depression appears to be a valid measure of mood in contrast to self-monitoring of mood in mania. There are yet few studies on the effect of electronic self-monitoring of mood in bipolar disorder. The evidence of electronic self-monitoring is limited by methodological issues and by a lack of RCTs. Although the idea of electronic self-monitoring of mood seems appealing, studies using rigorous methodology investigating the beneficial as well as possible harmful effects of electronic self-monitoring are needed.

Pollution monitoring of Puget Sound with honey bees

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

Bromenshenk, J.J.; Carlson, S.R.; Simpson, J.C.

To show that honey bees are effective biological monitors of environmental contaminants over large geographic areas, beekeepers of Puget Sound, Washington, collected pollen and bees for chemical analysis. From these data, kriging maps of arsenic, cadmium, and fluoride were generated. Results, based on actual concentrations of contaminants in bee tissues, show that the greatest concentrations of contaminants occur close to Commencement Bay and that honey bees are effective as large-scale monitors. 27 references, 2 figures.

Plant Growth Module (PGM) conceptual design

NASA Technical Reports Server (NTRS)

Schwartzkopf, Steven H.; Rasmussen, Daryl

1987-01-01

The Plant Growth Module for the Controlled Ecological Life Support System (CELSS), designed to answer basic science questions related to growing plants in closed systems, is described functionally with artist's conception drawings. Subsystems are also described, including enclosure and access; data acquisition and control; gas monitor and control; heating, ventilation, and air conditioning; air delivery; nutrient monitor and control; microbial monitoring and control; plant support and nutrient delivery; illumination; and internal operations. The hardware development plan is outlined.

Longitudinal Associations Between Parental Monitoring Discrepancy and Delinquency: An Application of the Latent Congruency Model.

PubMed

Ksinan, Albert J; Vazsonyi, Alexander T

2016-12-01

Studies have shown that discrepancies (relative concordance or discordance) between parent and adolescent ratings are predictive of problem behaviors; monitoring, in particular, has been consistently linked to them. The current study tested whether discrepancies in perceptions of maternal monitoring, rated by mothers and youth at age 12, foretold delinquency (rule breaking) at age 15, and whether parental closeness and conflict predicted higher discrepancies, and indirectly, higher delinquency. The final study sample used the NICHD longitudinal dataset with N = 966 youth (50.1 % female) and their mothers (80.1 % European American, 12.9 % African American, 7 % other ethnicity). The analytic approach consisted of an extension and application of the Latent Congruency Model (LCM) to estimate monitoring discrepancies as well as age 15 delinquency scores. Findings showed that age 12 monitoring discrepancy was predictive of age 15 delinquency for both boys and girls based on youth reports, but not for maternal reports. Age 11 closeness predicted age 12 monitoring discrepancy, which served as a mediator for its effect on age 15 adolescent-reported delinquency. Thus, based on the rigorous LCM analytic approach which seeks to minimize the effects by competing explanations and to maximize precision in providing robust estimates, rates of perceived discordance in parenting behaviors during early adolescence matter in understanding variability in adolescent delinquency during middle adolescence.

The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy, compared with standard UK practice: systematic review and economic evaluation.

PubMed

Sharma, Pawana; Scotland, Graham; Cruickshank, Moira; Tassie, Emma; Fraser, Cynthia; Burton, Chris; Croal, Bernard; Ramsay, Craig R; Brazzelli, Miriam

2015-06-01

Self-monitoring (self-testing and self-management) could be a valid option for oral anticoagulation therapy monitoring in the NHS, but current evidence on its clinical effectiveness or cost-effectiveness is limited. We investigated the clinical effectiveness and cost-effectiveness of point-of-care coagulometers for the self-monitoring of coagulation status in people receiving long-term vitamin K antagonist therapy, compared with standard clinic monitoring. We searched major electronic databases (e.g. MEDLINE, MEDLINE In Process & Other Non-Indexed Citations, EMBASE, Bioscience Information Service, Science Citation Index and Cochrane Central Register of Controlled Trials) from 2007 to May 2013. Reports published before 2007 were identified from the existing Cochrane review (major databases searched from inception to 2007). The economic model parameters were derived from the clinical effectiveness review, other relevant reviews, routine sources of cost data and clinical experts' advice. We assessed randomised controlled trials (RCTs) evaluating self-monitoring in people with atrial fibrillation or heart valve disease requiring long-term anticoagulation therapy. CoaguChek(®) XS and S models (Roche Diagnostics, Basel, Switzerland), INRatio2(®) PT/INR monitor (Alere Inc., San Diego, CA USA), and ProTime Microcoagulation system(®) (International Technidyne Corporation, Nexus Dx, Edison, NJ, USA) coagulometers were compared with standard monitoring. Where possible, we combined data from included trials using standard inverse variance methods. Risk of bias assessment was performed using the Cochrane risk of bias tool. A de novo economic model was developed to assess the cost-effectiveness over a 10-year period. We identified 26 RCTs (published in 45 papers) with a total of 8763 participants. CoaguChek was used in 85% of the trials. Primary analyses were based on data from 21 out of 26 trials. Only four trials were at low risk of bias. Major clinical events: self-monitoring was significantly better than standard monitoring in preventing thromboembolic events [relative risk (RR) 0.58, 95% confidence interval (CI) 0.40 to 0.84; p = 0.004]. In people with artificial heart valves (AHVs), self-monitoring almost halved the risk of thromboembolic events (RR 0.56, 95% CI 0.38 to 0.82; p = 0.003) and all-cause mortality (RR 0.54, 95% CI 0.32 to 0.92; p = 0.02). There was greater reduction in thromboembolic events and all-cause mortality through self-management but not through self-testing. Intermediate outcomes: self-testing, but not self-management, showed a modest but significantly higher percentage of time in therapeutic range, compared with standard care (weighted mean difference 4.44, 95% CI 1.71 to 7.18; p = 0.02). Patient-reported outcomes: improvements in patients' quality of life related to self-monitoring were observed in six out of nine trials. High preference rates were reported for self-monitoring (77% to 98% in four trials). Net health and social care costs over 10 years were £7295 (self-monitoring with INRatio2); £7324 (standard care monitoring); £7333 (self-monitoring with CoaguChek XS) and £8609 (self-monitoring with ProTime). The estimated quality-adjusted life-year (QALY) gain associated with self-monitoring was 0.03. Self-monitoring with INRatio2 or CoaguChek XS was found to have ≈ 80% chance of being cost-effective, compared with standard monitoring at a willingness-to-pay threshold of £20,000 per QALY gained. Compared with standard monitoring, self-monitoring appears to be safe and effective, especially for people with AHVs. Self-monitoring, and in particular self-management, of anticoagulation status appeared cost-effective when pooled estimates of clinical effectiveness were applied. However, if self-monitoring does not result in significant reductions in thromboembolic events, it is unlikely to be cost-effective, based on a comparison of annual monitoring costs alone. Trials investigating the longer-term outcomes of self-management are needed, as well as direct comparisons of the various point-of-care coagulometers. This study is registered as PROSPERO CRD42013004944. The National Institute for Health Research Health Technology Assessment programme.

Clinical characteristics of children with fever and transient neutropenia who experience serious bacterial infections.

PubMed

Bonadio, W A; Stremski, E; Shallow, K

1989-09-01

A review of consecutive previously healthy children with fever and newly discovered neutropenia without underlying malignancy, evaluated during a three-year period, was performed. A total of 68 episodes occurred in 68 patients; blood culture was performed on each. Of 17 patients who appeared compromised (ill, irritable, toxic) on presentation, five (30%) had either bacteremia or bacterial meningitis. All five patients had clinical evidence of a fulminant disease process on examination. By contrast, all 51 patients who appeared to be well on presentation were culture-negative. Fever and new-onset neutropenia in children is a heterogeneous disorder with several outcomes. Any child with fever and newly discovered neutropenia who appears ill should be presumed to be at high risk for systemic bacterial infection and receive hospitalization for parenteral antibiotic therapy. By contrast, the previously healthy child older than two months of age with fever and new-onset neutropenia who appears to be well, and whose clinical evaluation does not indicate a serious underlying disease process, is at low risk for accompanying systemic bacterial infection; hospitalization with empiric antibiotic therapy pending culture results is not warranted for the majority of such children. Close outpatient monitoring with serial evaluation of the peripheral blood absolute neutrophil count to document bone marrow recovery is recommended for such cases.

Antibiotic resistance in severe odontogenic infections of the South Australian population: a 9-year retrospective audit.

PubMed

Liau, I; Han, J; Bayetto, K; May, B; Goss, A; Sambrook, P; Cheng, A

2018-06-01

The aims of this study were to evaluate the microbiological trends in severe odontogenic infections requiring hospital admission in the South Australian Oral and Maxillofacial Surgery Unit. Rates of antibiotic resistance to empirical antibiotic regimens were determined to quantify the clinical implications of antibiotic-resistant odontogenic infections. A retrospective case audit was performed on all odontogenic infections admitted to the Royal Adelaide Hospital over a 9-year period. Data was collected regarding demographics, microbiological culture and sensitivity results, and clinical outcome variables. Of a total of 672 patients, microbiology data was available for 447 cases. Penicillin-resistant organisms were identified in 10.8% of patients, who required a significantly longer length of hospital admission (mean, 9.93 days) and higher rates of non-response to initial surgical therapy (40%). There were moderate rates of antibiotic-resistant odontogenic infections within the South Australian population. Patients within this subgroup demonstrate markedly poorer clinical outcomes. Effective treatment of odontogenic infections involves early operative intervention, with adjunctive use of appropriate antibiotic therapy that involves close monitoring of response to removal of the cause and use of first-line antibiotic agents. Cases that fail to respond require urgent specialist review in order to reduce morbidity and mortality outcomes. © 2018 Australian Dental Association.

Catatonic variants, hyperthermic extrapyramidal reactions, and subtypes of neuroleptic malignant syndrome.

PubMed

Lee, Joseph W Y

2007-01-01

This case series study examines the hypothesis that neuroleptic malignant syndrome (NMS) is a heterogeneous condition including catatonic variants and non-catatonic pathological reactions to antipsychotics. Fourteen episodes of NMS were prospectively identified. Patients were examined for catatonia during the course of NMS. Close monitoring of catatonia episodes and suspected cases of evolving NMS for possible NMS development provided data on the pre-NMS clinical course. All NMS episodes received benzodiazepines. Episodes with catatonia diagnosed were compared with those without catatonia, noting their presentation, clinical course and responses to treatment. Concurrent catatonia was diagnosed in 9 episodes. In 6 of them antecedent catatonia progressed to NMS following antipsychotic exposure (NMS of antipsychotic-converted catatonia). In 3 episodes, a parkinsonian-catatonic syndrome with fever and autonomic abnormality developed in reaction to antipsychotics (NMS of antipsychotic-induced catatonia). Catatonia was not diagnosed in 5 during the longitudinal course of NMS. A severe extrapyramidal reaction to antipsychotics with associated delirium preceded all 5 episodes. Seven of the 9 NMS episodes with catatonia and none of the 5 without catatonia showed significant responses to benzodiazepines. The preliminary findings support the hypothesis that NMS is a heterogeneous condition including catatonic variants and non-catatonic hyperthermic extrapyramidal reactions to antipsychotics, differing in presentation, clinical course, and treatment responses.

Quality assurance of research protocols conducted in the community: the National Institute on Drug Abuse Clinical Trials Network experience.

PubMed

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-04-01

Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. : QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed.

Quality assurance of research protocols conducted in the community: The National Institute on Drug Abuse Clinical Trials Network Experience

PubMed Central

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-01-01

Background: Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. Purpose: This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. Methods: The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Results: Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. Limitations: QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. Conclusions: The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed. PMID:19342468

'Treat to Target' - Lessons Learnt.

PubMed

Kurti, Zsuzsanna; Vegh, Zsuzsanna; Golovics, Petra Anna; Lakatos, Peter Laszlo

2016-01-01

Therapeutic management in inflammatory bowel diseases (IBD) has significantly changed in the last decades with the advent of biological therapy resulting in new treatment targets other than clinical symptoms. Patient stratification in the early stage of the disease is an important step to identify patients with poor prognosis, who might benefit from early aggressive treatment to avoid complications in the later disease course. Recent randomized and hypothesis driven (e.g., Randomized Evaluation of an Algorithm for Crohn's Treatment, Post-Operative Crohn's Endoscopic Recurrence) clinical trials conducted in the biological era underscore the need of objective disease monitoring including assessment of biomarkers (e.g., C-reactive protein and calprotectin), mucosal healing and, for biologically treated patients, therapeutic drug monitoring beside clinical symptom assessment in both Crohn's disease and ulcerative colitis. Assessing the treatment efficacy objectively has become an important element of patient monitoring besides clinical symptom assessment. Further clinical studies are needed to assess whether implementation of new therapeutic algorithms based on these targets and tight monitoring in clinical practice have the potential to further improve long-term disease outcomes in IBD. © 2016 S. Karger AG, Basel.

Reporting of neuropsychological dysfunction remains discrepant between individuals with traumatic brain injury and their close others up to five years post-injury.

PubMed

Stolwyk, Renerus J; Ponsford, Jennie L

2015-12-22

The degree to which individuals with traumatic brain injury (TBI) and their close others share a common understanding and experience of post-injury neuropsychological changes is currently unclear. The aim of this preliminary study was to longitudinally examine levels of agreement between self and close other reports of neuropsychological dysfunction following TBI and explore factors associated with these agreement levels. Sixty-three people with TBI and their nominated close others independently completed the Structured Outcome Questionnaire at 1- and 5-years post-injury, reporting whether the person with TBI was experiencing any negative cognitive, behavioural or emotional changes compared to pre-injury. Agreement levels between pair members ranged from chance to approximately 75% across neuropsychological domains and did not significantly change over 1- and 5-year time points. In the case of pair disagreement, close others were generally more likely to report difficulties. Pair disagreement was significantly associated with close other anxiety. Agreement between self and close others remains limited up to 5-years post-injury which questions the practice of using these reports interchangeably in research and clinical practice. Preliminary findings suggest some association between pair disagreement and close other psychological function; however, further research is warranted. Implications for Rehabilitation Reporting of neuropsychological dysfunction between individuals with TBI and their close others is not sufficiently reliable to warrant interchangeable use within research or clinical practice. Including both individuals with TBI and their close others in clinical assessments will facilitate a more holistic understanding of the client's difficulties and their relationships with those close to them. Preliminary findings indicate that disagreement between individuals with TBI and their close others may be associated with close other anxiety. Clinicians should be aware of the potential for disagreement to impact on the psychological health of close others.

Electronic monitoring of adherence to inhaled corticosteroids: an essential tool in identifying severe asthma in children.

PubMed

Jochmann, Anja; Artusio, Luca; Jamalzadeh, Angela; Nagakumar, Prasad; Delgado-Eckert, Edgar; Saglani, Sejal; Bush, Andrew; Frey, Urs; Fleming, Louise J

2017-12-01

International guidelines recommend that severe asthma can only be diagnosed after contributory factors, including adherence, have been addressed. Accurate assessment of adherence is difficult in clinical practice. We hypothesised that electronic monitoring in children would identify nonadherence, thus delineating the small number with true severe asthma.Asthmatic children already prescribed inhaled corticosteroids were prospectively recruited and persistence of adherence assessed using electronic monitoring devices. Spirometry, airway inflammation and asthma control were measured at the start and end of the monitoring period.93 children (62 male; median age 12.4 years) were monitored for a median of 92 days. Median (range) monitored adherence was 74% (21-99%). We identified four groups: 1) good adherence during monitoring with improved control, 24% (likely previous poor adherence); 2) good adherence with poor control, 18% (severe therapy-resistant asthma); 3) poor adherence with good control, 26% (likely overtreated); and 4) poor adherence with poor control, 32%. No clinical parameter prior to monitoring distinguished these groups.Electronic monitoring is a useful tool for identifying children in whom a step up in treatment is indicated. Different approaches are needed in those who are controlled when adherent or who are nonadherent. Electronic monitoring is essential in a paediatric severe asthma clinic. Copyright ©ERS 2017.

Feasibility of A-mode ultrasound attenuation as a monitoring method of local hyperthermia treatment.

PubMed

Manaf, Noraida Abd; Aziz, Maizatul Nadwa Che; Ridzuan, Dzulfadhli Saffuan; Mohamad Salim, Maheza Irna; Wahab, Asnida Abd; Lai, Khin Wee; Hum, Yan Chai

2016-06-01

Recently, there is an increasing interest in the use of local hyperthermia treatment for a variety of clinical applications. The desired therapeutic outcome in local hyperthermia treatment is achieved by raising the local temperature to surpass the tissue coagulation threshold, resulting in tissue necrosis. In oncology, local hyperthermia is used as an effective way to destroy cancerous tissues and is said to have the potential to replace conventional treatment regime like surgery, chemotherapy or radiotherapy. However, the inability to closely monitor temperature elevations from hyperthermia treatment in real time with high accuracy continues to limit its clinical applicability. Local hyperthermia treatment requires real-time monitoring system to observe the progression of the destroyed tissue during and after the treatment. Ultrasound is one of the modalities that have great potential for local hyperthermia monitoring, as it is non-ionizing, convenient and has relatively simple signal processing requirement compared to magnetic resonance imaging and computed tomography. In a two-dimensional ultrasound imaging system, changes in tissue microstructure during local hyperthermia treatment are observed in terms of pixel value analysis extracted from the ultrasound image itself. Although 2D ultrasound has shown to be the most widely used system for monitoring hyperthermia in ultrasound imaging family, 1D ultrasound on the other hand could offer a real-time monitoring and the method enables quantitative measurement to be conducted faster and with simpler measurement instrument. Therefore, this paper proposes a new local hyperthermia monitoring method that is based on one-dimensional ultrasound. Specifically, the study investigates the effect of ultrasound attenuation in normal and pathological breast tissue when the temperature in tissue is varied between 37 and 65 °C during local hyperthermia treatment. Besides that, the total protein content measurement was also conducted to investigate the relationship between attenuation and tissue denaturation level at different temperature ranges. The tissues were grouped according to their histology results, namely normal tissue with large predominance of cells (NPC), cancer tissue with large predominance of cells (CPC) and cancer with high collagen fiber content (CHF). The result shows that the attenuation coefficient of ultrasound measured following the local hyperthermia treatment increases with the increment of collagen fiber content in tissue as the CHF attenuated ultrasound at the highest rate, followed by NPC and CPC. Additionally, the attenuation increment is more pronounced at the temperature over 55 °C. This describes that the ultrasound wave experienced more energy loss when it propagates through a heated tissue as the tissue structure changes due to protein coagulation effect. Additionally, a significant increase in the sensitivity of attenuation to protein denaturation is also observed with the highest sensitivity obtained in monitoring NPC. Overall, it is concluded that one-dimensional ultrasound can be used as a monitoring method of local hyperthermia since its attenuation is very sensitive to the changes in tissue microstructure during hyperthermia.

Dynamic extreme values modeling and monitoring by means of sea shores water quality biomarkers and valvometry.

PubMed

Durrieu, Gilles; Pham, Quang-Khoai; Foltête, Anne-Sophie; Maxime, Valérie; Grama, Ion; Tilly, Véronique Le; Duval, Hélène; Tricot, Jean-Marie; Naceur, Chiraz Ben; Sire, Olivier

2016-07-01

Water quality can be evaluated using biomarkers such as tissular enzymatic activities of endemic species. Measurement of molluscs bivalves activity at high frequency (e.g., valvometry) during a long time period is another way to record the animal behavior and to evaluate perturbations of the water quality in real time. As the pollution affects the activity of oysters, we consider the valves opening and closing velocities to monitor the water quality assessment. We propose to model the huge volume of velocity data collected in the framework of valvometry using a new nonparametric extreme values statistical model. The objective is to estimate the tail probabilities and the extreme quantiles of the distribution of valve closing velocity. The tail of the distribution function of valve closing velocity is modeled by a Pareto distribution with parameter t,τ , beyond a threshold τ according to the time t of the experiment. Our modeling approach reveals the dependence between the specific activity of two enzymatic biomarkers (Glutathione-S-transferase and acetylcholinesterase) and the continuous recording of oyster valve velocity, proving the suitability of this tool for water quality assessment. Thus, valvometry allows in real-time in situ analysis of the bivalves behavior and appears as an effective early warning tool in ecological risk assessment and marine environment monitoring.

Pacemaker remote monitoring in the pediatric population: is it a real solution?

PubMed

Leoni, Loira; Padalino, Massimo; Biffanti, Roberta; Ferretto, Sonia; Vettor, Giulia; Corrado, Domenico; Stellin, Giovanni; Milanesi, Ornella; Iliceto, Sabino

2015-05-01

Clinical utility of remote monitoring of implantable cardiac devices has been previously demonstrated in several trials in the adult population. The aim of this study was to assess the clinical utility of remote monitoring in a pediatric population undergoing pacemakers implantation. The study population included 73 consecutive pediatric patients who received an implantable pacemaker. The remote device check was programmed for every 3 months and all patients had a yearly out-patient visit. Data on device-related events, hospitalization, and other clinical information were collected during remote checks and out-patient visits. During a mean follow-up of 18 ± 10 months, 470 remote transmissions were collected and analyzed. Two deaths were reported. Eight transmissions (1.7%) triggered an urgent out-patient visit. Twenty percent of transmissions reported evidence of significant clinical or technical events. All young patients and their families were very satisfied when using remote monitoring to replace out-patient visits. The ease in use, together with satisfaction and acceptance of remote monitoring in pediatric patients, brought very good results. The remote management of our pediatric population was safe and remote monitoring adequately replaced the periodic out-patient device checks without compromising patient safety. ©2015 Wiley Periodicals, Inc.

Detrimental Effects of Earphone Conversation on Auditory Environmental Monitoring of Visually Impaired People

ERIC Educational Resources Information Center

Verstijnen, I. M.; van Mierlo, C. M.; de Ruijter, P.

2008-01-01

In order to investigate the effect of concurrent phoning and auditory environmental monitoring, the performance of visually impaired people was observed on a dual task that consisted of two simulation tasks. Subjects wore either a bone conducting headset, or closed or open (air conduction) earphones. Reaction times and the correctness of responses…

Integrated Circuit Wear out Prediction and Recycling Detection using Radio Frequency Distinct Native Attribute Features

DTIC Science & Technology

2016-12-22

105 A.1 Main Loop ... loop monitoring for preventative maintenance rather than early replacement based on statistical projections or replacement-after- failure schemes. IC...estimates, RF-DNA may provide a means to track an IC’s physical degradation during actual use. Monitoring an IC’s degradation in a closed loop fashion

Measuring Changes in Family Wellbeing in New Zealand 1981-2001

ERIC Educational Resources Information Center

Cotterell, Gerard; Wheldon, Mark; Milligan, Sue

2008-01-01

Since the mid-1980s, New Zealand has experienced extensive economic, social and political reforms. The economic impact of these changes has been closely monitored and much commented upon. However, the social impacts of the reforms on different family types are less well understood. This paper outlines a project designed to monitor how the reforms…

In the aftermath of SPRINT: further comparison of unattended automated office blood pressure measurement and 24-hour blood pressure monitoring.

PubMed

Seidlerová, Jitka; Gelžinský, Julius; Mateřánková, Markéta; Ceral, Jiří; König, Petr; Filipovský, Jan

2018-03-22

Several papers reported that unattended automated office blood pressure (uAutoOBP) is closely related to daytime ambulatory blood pressure monitoring (ABPM). In the present study, we aim to study uAutoOBP and its relation to 24-hour ABPM and ABPM variability. Stable treated hypertensive subjects were examined in two Czech academic hypertension centres. uAutoOBP was measured with the BP Tru device; attended BP three times with auscultatory method (AuscOBP) by the physician. ABPM was performed within one week from the clinical visit. Data on 98 subjects aged 67.7 ± 9.3 years with 24-hour ABPM 120.3 ± 10.6/72.7 ± 7.9 mm Hg are reported. uAutoOBP was lower than 24-hour (by -5.2 ± 11.3/-0.5 ± 6.9 mm Hg) and daytime (by -6.7 ± 12.82.4 ± 8.0 mm Hg) ABPM and the individual variability of the difference was very large (up to 30 mm Hg). The correlation coefficients between ABPM and uAutoOBP were similar compared to AuscOBP (p ≥ .17). Variability of uAutoOBP, but not AuscOBP, readings during one clinical visit was related to short-term blood pressure variability of ABPM. The difference between AuscOBP and uAutoOBP was larger in patients with white-coat effect compared to other blood pressure control groups (25.1 ± 7.0 vs. 2.2 ± 10.3 mm Hg; p = .0036). Our study shows that uAutoOBP is not good predictor of ambulatory blood pressure monitoring, not even of the daytime values. It might, however, indicate short-term blood pressure variability and, when compared with AuscOBP, also detect patients with white-coat effect.

Early Changes of Mannose-Binding Lectin, H-Ficolin, and Procalcitonin in Patients with Febrile Neutropenia: A Prospective Observational Study.

PubMed

Işlak Mutcalı, Sibel; Saltoğlu, Neşe; Balkan, İlker İnanç; Özaras, Reşat; Yemişen, Mücahit; Tabak, Fehmi; Mert, Ali; Öztürk, Recep; Öngören, Şeniz; Başlar, Zafer; Aydın, Yıldız; Ferhanoğlu, Burhan; Soysal, Teoman

2016-12-01

The significance of mannose-binding lectin (MBL) and H-ficolin deficiency in febrile neutropenic (FN) patients and the correlation of these markers along with consecutive C-reactive protein (CRP) and procalcitonin (PCT) levels during the infectious process are investigated. Patients with any hematological malignancies who were defined to have "microbiologically confirmed infection", "clinically documented infection", or "fever of unknown origin" were included in this single-center prospective observational study. Serum levels of CRP, PCT, MBL, and H-ficolin were determined on 3 separate occasions: at baseline (between hospital admission and chemotherapy), at the onset of fever, and at the 72nd hour of fever. Forty-six patients (54% male, mean age 41.7 years) with 61 separate episodes of FN were evaluated. Eleven patients (23.9%) had "microbiologically confirmed infection", 17 (37%) had "clinically documented infection", and 18 (39.1%) had "fever of unknown origin". Fourteen (30.4%) patients had low (<500 ng/mL) initial MBL levels and 7 (15.21%) had low (<12,000 ng/mL) H-ficolin levels. Baseline MBL and H-ficolin levels did not significantly change on the first and third days of fever (p=0.076). Gram-negative bacteremia more frequently occurred in those with low initial MBL levels (p=0.006). PCT levels were significantly higher in those with microbiologically documented infections. Mean and median PCT levels were significantly higher in cases with bacteremia. There was no significant difference between hemoculture-positive and-negative patients in terms of CRP levels. Monitoring serum H-ficolin levels was shown to be of no benefit in terms of predicting severe infection. Low baseline MBL levels were correlated with high risk of gram-negative bacteremia; however, no significant correlation was shown in the follow-up. Close monitoring of PCT levels is warranted to provide more accurate and specific data while monitoring cases of bacteremia.

Post-prandial reflux suppression by a raft-forming alginate (Gaviscon Advance) compared to a simple antacid documented by magnetic resonance imaging and pH-impedance monitoring: mechanistic assessment in healthy volunteers and randomised, controlled, double-blind study in reflux patients.

PubMed

Sweis, R; Kaufman, E; Anggiansah, A; Wong, T; Dettmar, P; Fried, M; Schwizer, W; Avvari, R K; Pal, A; Fox, M

2013-06-01

Alginates form a raft above the gastric contents, which may suppress gastro-oesophageal reflux; however, inconsistent effects have been reported in mechanistic and clinical studies. To visualise reflux suppression by an alginate-antacid [Gaviscon Advance (GA), Reckitt Benckiser, UK] compared with a nonraft-forming antacid using magnetic resonance imaging (MRI), and to determine the feasibility of pH-impedance monitoring for assessment of reflux suppression by alginates. Two studies were performed: (i) GA and antacid (Alucol, Wander Ltd, Switzerland) were visualised in the stomach after ingestion in 12 healthy volunteers over 30 min after a meal by MRI, with reflux events documented by manometry. (ii) A randomised controlled, double-blind cross-over trial of post-prandial reflux suppression documented by pH-impedance in 20 patients randomised to GA or antacid (Milk of Magnesia; Boots, UK) after two meals taken 24 h apart. MRI visualized a "mass" of GA form at the oesophago-gastric junction (OGJ); simple antacid sank to the distal stomach. The number of post-prandial common cavity reflux events was less with GA than antacid [median 2 (0-5) vs. 5 (1-11); P < 0.035]. Distal reflux events and acid exposure measured by pH-impedance were similar after GA and antacid. There was a trend to reduced proximal reflux events with GA compared with antacid [10.5 (8.9) vs. 13.9 (8.3); P = 0.070]. Gaviscon Advance forms a 'mass' close to the OGJ and significantly suppresses reflux compared with a nonraft-forming antacid. Standard pH-impedance monitoring is suitable for clinical studies of GA in gastro-oesophageal reflux disease patients where proximal reflux is the primary outcome. © 2013 Blackwell Publishing Ltd.

The impact of continuous versus intermittent vital signs monitoring in hospitals: A systematic review and narrative synthesis.

PubMed

Downey, C L; Chapman, S; Randell, R; Brown, J M; Jayne, D G

2018-08-01

Continuous vital signs monitoring on general hospital wards may allow earlier detection of patient deterioration and improve patient outcomes. This systematic review will assess if continuous monitoring is practical outside of the critical care setting, and whether it confers any clinical benefit to patients. MEDLINE ® , MEDLINE ® In-Process, EMBASE, CINAHL and The Cochrane Library were searched for articles that evaluated the clinical or non-clinical outcomes of continuous vital signs monitoring in adults outside of the critical care setting. The protocol was registered with PROSPERO (CRD42017058098). Twenty-four studies met the inclusion criteria and reported outcomes on a total of 40,274 patients and 59 ward staff in nine countries. The majority of studies showed benefits in terms of critical care use and length of hospital stay. Larger studies were more likely to demonstrate clinical benefit, particularly critical care use and length of hospital stay. Three studies showed cost-effectiveness. Barriers to implementation included nursing and patient satisfaction and the burden of false alerts. Continuous vital signs monitoring outside the critical care setting is feasible and may provide a benefit in terms of improved patient outcomes and cost efficiency. Large, well-controlled studies in high-risk populations are required to evaluate the clinical benefit of continuous monitoring systems. Copyright © 2018 Elsevier Ltd. All rights reserved.

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 routine clinical practice. The technique is ripe for widespread application.

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. Copyright © 2018 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Remotely Monitored Sealing Array Software

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

2012-09-12

The Remotely Monitored Sealing Array (RMSA) utilizes the Secure Sensor Platform (SSP) framework to establish the fundamental operating capabilities for communication, security, power management, and cryptography. In addition to the SSP framework the RMSA software has unique capabilities to support monitoring a fiber optic seal. Fiber monitoring includes open and closed as well as parametric monitoring to detect tampering attacks. The fiber monitoring techniques, using the SSP power management processes, allow the seals to last for years while maintaining the security requirements of the monitoring application. The seal is enclosed in a tamper resistant housing with software to support activemore » tamper monitoring. New features include LED notification of fiber closure, the ability to retrieve the entire fiber optic history via translator command, separate memory storage for fiber optic events, and a more robust method for tracking and resending failed messages.« less

Atrial fibrillation ablation using a closed irrigation radiofrequency ablation catheter.

PubMed

Golden, Keith; Mounsey, John Paul; Chung, Eugene; Roomiani, Pahresah; Morse, Michael Andew; Patel, Ankit; Gehi, Anil

2012-05-01

Catheter ablation is an effective therapy for symptomatic, medically refractory atrial fibrillation (AF). Open-irrigated radiofrequency (RF) ablation catheters produce transmural lesions at the cost of increased fluid delivery. In vivo models suggest closed-irrigated RF catheters create equivalent lesions, but clinical outcomes are limited. A cohort of 195 sequential patients with symptomatic AF underwent stepwise AF ablation (AFA) using a closed-irrigation ablation catheter. Recurrence of AF was monitored and outcomes were evaluated using Kaplan-Meier survival analysis and Cox proportional hazards models. Mean age was 59.0 years, 74.9% were male, 56.4% of patients were paroxysmal and mean duration of AF was 5.4 years. Patients had multiple comorbidities including hypertension (76.4%), tobacco abuse (42.1%), diabetes (17.4%), and obesity (mean body mass index 30.8). The median follow-up was 55.8 weeks. Overall event-free survival was 73.6% with one ablation and 77.4% after reablation (reablation rate was 8.7%). Median time to recurrence was 26.9 weeks. AF was more likely to recur in patients being treated with antiarrhythmic therapy at the time of last follow-up (recurrence rate 30.3% with antiarrhythmic drugs, 13.2% without antiarrhythmic drugs; hazard ratio [HR] 2.2, 95% confidence interval [CI] 1.1-4.4, P = 0.024) and in those with a history of AF greater than 2 years duration (HR 2.7, 95% CI 1.1-6.9, P = 0.038). Our study represents the largest cohort of patients receiving AFA with closed-irrigation ablation catheters. We demonstrate comparable outcomes to those previously reported in studies of open-irrigation ablation catheters. Given the theoretical benefits of a closed-irrigation system, a large head-to-head comparison using this catheter is warranted. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.