Circadian variation in QT dispersion determined from a 12-lead Holter recording

DEFF Research Database (Denmark)

Hansen, Stig; Rasmussen, Verner; Larsen, Klaus

2007-01-01

Background: QT dispersion is considered to reflect inhomogeneity of myocardial repolarization. Method: The circadian variation of QT interval dispersion was examined in 95 healthy subjects using 24-hour Holter monitoring. Three different methods of lead selection were applied: all 12 leads (QTdisp...... circadian variation using mean values of QTdisp 12, QTdisp 6, or QTdisp 2 obtained every hour, every 2, or every 4 hours, except in QTdisp 6, which demonstrated a significant circadian variation (P ... a significant circadian variation in QTdisp 12 and QTdisp 6 (P circadian variation was seen in QTdisp 2. A subdivision into 10-year age groups revealed that subjects at age >50 years had a significant circadian variation in QTdisp 12 and QTdisp 6, but not in QTdisp 2. Only in males...

Heritability of ECG Biomarkers in the Netherlands Twin Registry Measured from Holter ECGs.

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Emily C Hodkinson

2016-04-01

Full Text Available INTRODUCTIONThe resting ECG is the most commonly used tool to assess cardiac electrophysiology. Previous studies have estimated heritability of ECG parameters based on these snapshots of the cardiac electrical activity. In this study we set out to determine whether analysis of heart rate specific data from Holter ECGs allows more complete assessment of the heritability of ECG parameters.METHODS and RESULTSHolter ECGs were recorded from 221 twin pairs and analyzed using a multi-parameter beat binning approach. Heart rate dependent estimates of heritability for QRS duration, QT interval, Tpeak–Tend and Theight were calculated using structural equation modelling. QRS duration is largely determined by environmental factors whereas repolarization is primarily genetically determined. Heritability estimates of both QT interval and Theight were significantly higher when measured from Holter compared to resting ECGs and the heritability estimate of each was heart rate dependent. Analysis of the genetic contribution to correlation between repolarization parameters demonstrated that covariance of individual ECG parameters at different heart rates overlap but at each specific heart rate there was relatively little overlap in the genetic determinants of the different repolarization parameters.CONCLUSIONSHere we present the first study of heritability of repolarization parameters measured from Holter ECGs. Our data demonstrate that higher heritability can be estimated from the Holter than the resting ECG and reveals rate dependence in the genetic – environmental determinants of the ECG that has not previously been tractable. Future applications include deeper dissection of the ECG of participants with inherited cardiac electrical disease.

An update on insertable cardiac monitors

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

2015-01-01

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...... 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....

Design of a Holter for Electroencephalography and Polysomnography

International Nuclear Information System (INIS)

Martin Gonzalez, Francisco; Velarde Reyes, Ernesto

2009-01-01

This paper presents the design of a 40 digital channels Holter for ambulatory studies of electroencephalography(EEG) and polisomnography (PSG), specially for epilepsy and sleep disorders. It includes a revision of the market and technologies used in such equipment. The requirements of design are established, and solutions are presented. It shows a functional diagram of the system including technologies like wireless communication, reading and writing in USB flash devices and a new amplifier design with dynamic compensation of direct current polarization

Yield of atrial fibrillation detection with Textile Wearable Holter from the acute phase of stroke: Pilot study of Crypto-AF registry.

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Pagola, Jorge; Juega, Jesus; Francisco-Pascual, Jaume; Moya, Angel; Sanchis, Mireia; Bustamante, Alejandro; Penalba, Anna; Usero, Maria; Cortijo, Elisa; Arenillas, Juan F; Calleja, Ana I; Sandin-Fuentes, Maria; Rubio, Jeronimo; Mancha, Fernando; Escudero-Martinez, Irene; Moniche, Francisco; de Torres, Reyes; Pérez-Sánchez, Soledad; González-Matos, Carlos E; Vega, Ángela; Pedrote, Alonso A; Arana-Rueda, Eduardo; Montaner, Joan; Molina, Carlos A

2018-01-15

We describe the feasibility of monitoring with a Textile Wearable Holter (TWH) in patients included in Crypto AF registry. We monitored cryptogenic stroke patients from stroke onset (<3days) continuously during 28days. We employed a TWH composed by a garment and a recorder. We compared two garments (Lead and Vest) to assess rate of undiagnosed Atrial Fibrillation (AF) detection, monitoring compliance, comfortability (1 to 5 points), skin lesions, and time analyzed. We describe the timing of AF detection in three periods (0-3, 4-15 and 16-28days). The rate of undiagnosed AF detection with TWH was 21.9% (32 out of 146 patients who completed the monitoring). Global time compliance was 90% of the time expected (583/644h). The level of comfortability was 4 points (IQR 3-5). We detected reversible skin lesions in 5.47% (8/146). The comfortability was similar but time compliance (in hours) was longer in Vest group 591 (IQR [521-639]) vs. Lead 566 (IQR [397-620]) (p=0.025). Also, time analyzed was more prolonged in Vest group 497 (IQR [419-557]) vs. Lead (336h (IQR [140-520]) (p=0.001)). The incidence of AF increases from 5.6% (at 3days) to 17.5% (at 15th day) and up to 20.9% (at 28th day). The percentage of AF episodes detected only in each period was 12.5% (0-3days); 21.7% (4-15days) and 19% (16-28days). 28days Holter monitoring from the acute phase of the stroke was feasible with TWH. Following our protocol, only five patients were needed to screen to detected one case of AF. Copyright © 2017 Elsevier B.V. All rights reserved.

Atrial fibrillation detected by external loop recording for seven days or two-day simultaneous Holter recording: A comparison in patients with ischemic stroke or transient ischemic attack.

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Sejr, Michala Herskind; Nielsen, Jens Cosedis; Damgaard, Dorte; Sandal, Birgitte Forsom; May, Ole

Atrial fibrillation (AF) is the most common cardiac cause of ischemic stroke and transient ischemic attack (IS/TIA). To compare the diagnostic value of seven-day external loop recording (ELR) and two-day Holter recording for detecting AF after IS/TIA. 191 IS/TIA patients without AF history. Endpoint was AF >30s. We started two-day Holter recording and seven-day ELR simultaneously. Seven-day ELR and two-day Holter recording detected the same three AF patients. ELR detected another six patients with AF adjudicated by cardiologists, four detections after Holter (3 vs. 7, p=0.125) and two false-positive detections during Holter. Seven-day ELR automatically classified 50/191 patients (26%) with AF, but only 7/50 (14%) were confirmed as AF by cardiologists. Seven-day ELR did not detect significantly more patients with AF than two-day Holter recording. 86% of patients with ELR-classified AF were false positives, indicating a poor performance of the automatic AF detection algorithm used. Copyright © 2017 Elsevier Inc. All rights reserved.

45. Ezetimibe and statins yields on silent holter ambulatory myocardial ischemia

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W. Kadro

2016-07-01

Full Text Available Further cholestrol lowering may affect silent ischemia detected on holter monitoring. Cholesterol lowering is associated with a reduction in cardiovascular morbidity and mortality. Statins are the main drugs for cholesterol lowering. Ezetimibe when added to statins gives further reduction in cholesterol but its long-term effect on cardiovascular morbidity and mortality and ischemic events is not known. This study sought to determine whether further cholesterol lowering with ezitimibe will also results in a reduction of myocardial ischemia during daily life. We enrolled 50 patients with proven stable coronary artery disease (CAD and at least one episode of ST-segment depression on ambulatory ECG monitoring. All of them were receiving optimal therapy for CAD including statin therapy for cholesterol reduction. 25 patients were randomized to continue their statin therapy (Statin only group and 25 to recieve statin plus ezitimibe 10 mg/day (ezitimibe group. Serum cholesterol and LDL cholesterol levels and ambulatory monitoring were repeated after 4–6 months of therapy. The two groups were comparable with respect to baseline characteristics, number of episodes of ST-segment depression, and baseline serum cholesterol levels. The ezitimibe group had lower mean total and LDL cholesterol levels at study end and experienced a significant reduction in the number of episodes of ST-segment depression compared with the statin only group. ST-segment depression was completely resolved in 13 of 25 patients (52% in the ezitimibe group versus 3 of 25 (12% in the statin only group. The ezitimibe group exhibited a highly significant reduction in ambulatory ischemia (P < .001. By logistic regression, treatment with ezitimibe was an independent predictor of ischemia resolution. Further cholesterol lowering with ezitimibe can result in reduction or resolution of myocardial ischemia recorded as episodes of ST-segment depression in ambulatory monitoring of the ECG.

Clinical experience in extended cardiac monitoring with the SEEQ™ satellite wireless system

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Diego Vanegas-Cadavid

2018-05-01

Full Text Available Objectives: To present the clinical experience with a new extended (for 15 days, wireless, and satellite cardiac monitoring system in a group of patients with suspicion of cardiac arrhythmia. Method: The study included a cohort of 100 patients seen in the Cardiovascular Electrophysiology Unit of a reference hospital. They were suspected of having a cardiac arrhythmia, with no electrocardiographic diagnosis of the cause, despite previous examinations. They were subjected to SEEQ-type (Medtronic external cardiac monitoring for 15 days, with the outcomes recorded. Results: Of the total of 100 subjects studied, 51% were male, and the median age was 60 years (range: 5 - 91 years. The main symptoms were palpitation, and the most prevalent comorbidity was arterial hypertension (47%. Almost all (98% of them had a previous Holter study, and 46% had two studies, which were inconclusive in explaining the symptoms. The SEEQ monitoring recorded a significant electrocardiographic abnormality in 22% of the patients. A pacemaker implant was the treatment most applied and atrial fibrillation was the most frequent arrhythmia in 50% of the positive findings. There was a higher and significant percentage of positive diagnoses in males. Conclusions: External, satellite, wireless cardiac monitoring extended for 15 days, is a novel tool that can increase the probability of documenting a clinically significant electrocardiographic abnormality in those patients who suffer recurrent cardiovascular symptoms. Resumen: Objetivos: Dar a conocer la experiencia clínica con un nuevo sistema de monitorización cardiaca extendida (por 15 días, inalámbrica y satelital en un grupo de pacientes con sospecha de arritmias cardíacas. Metodología: Cohorte de 100 pacientes atendidos en la unidad de Electrofisiología cardiovascular de un centro de referencia, con sospecha de arritmia cardíaca, sin diagnóstico electrocardiográfico causal, a pesar de exámenes previos. Se les aplic

Evaluation of the indications and arrhythmic patterns of 24 hour Holter electrocardiography among hypertensive and diabetic patients seen at OAUTHC, Ile-Ife Nigeria

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Adebayo RA

2014-11-01

Full Text Available Rasaaq A Adebayo,1 Amanze N Ikwu,1 Michael O Balogun,1 Anthony O Akintomide,1 Tuoyo O Mene-Afejuku,1 Victor O Adeyeye,1 Olaniyi J Bamikole,1 Luqman A Bisiriyu,2 Olufemi E Ajayi,1 Suraj A Ogunyemi,1 Omolola A Oketona1 1Cardiology Unit, Department of Medicine, Obafemi Awolowo University Teaching Hospitals Complex, 2Department of Demography and Social Statistics, Obafemi Awolowo University, Ile-Ife, Osun State, Nigeria Background: There are very limited published studies in Nigeria on the use of 24 hour Holter electrocardiogram (Holter ECG in the arrhythmic evaluation of hypertensive and diabetic patients. Objective: To evaluate indications, arrhythmic pattern of Holter ECG, and heart rate variability (HRV among patients with hypertensive heart disease (HHD with or without heart failure and type 2 diabetes mellitus (T2DM seen in our cardiac care unit. Methods: Seventy-nine patients (32 males and 47 females were studied consecutively over a year using Schiller type (MT-101 Holter ECG machine. Results: Out of the 79 patients, 17 (21.5% had HHD without heart failure, 33 (41.8% had HHD with hypertensive heart failure (HHF, while 29 (36.7% were T2DM patients. The mean (standard deviation ages of HHD without heart failure, HHF and T2DM patients were 59.65 (±14.38, 65.15 (±14.30, and 54.66 (±8.88 respectively. The commonest indication for Holter ECG was palpitation (38%, followed by syncope (20.3%. Premature ventricular contraction was the commonest arrhythmic pattern among the 79 patients, especially among HHF patients. The HRV, using standard deviation of all normal-normal intervals was significantly reduced in T2DM patients (81.03±26.33, confidence interval [CI] =71.02–91.05 compared to the HHD without heart failure (119.65±29.86, CI =104.30–135.00 and HHF (107.03±62.50, CI =84.00–129.19. There was a negative correlation between the duration of T2DM and HRV (r=−0.613. Conclusion: Palpitation was the commonest Holter ECG indication and

Holter monitoring of central and peripheral temperature: possible uses and feasibility study in outpatient settings.

Science.gov (United States)

Varela, Manuel; Cuesta, David; Madrid, Juan Antonio; Churruca, Juan; Miro, Pau; Ruiz, Raul; Martinez, Carlos

2009-08-01

Conventional clinical thermometry has important limitations. A continuous monitoring of temperature may offer significant advantages, including the use of chronobiological and complexity analysis of temperature profile and eventually the identification of a "pre-febrile" pattern. We present a clinical model designed to measure, store and/or transmit in real time a central and a peripheral temperature reading. The results of its use in a healthy, free-living population is reported. Thirty subjects (15 women, 15 men, 20-70 years old), were monitored for 24 h while following their normal life. Temperatures were recorded every minute at the external auditory channel (EAC) and on the skin, at the intersection of the 5th intercostal space and the anterior axillary line. A Cosinor analysis and Approximate Entropy (ApEn) (m = 2, r = 0.15*SD, N = 180) were calculated for both temperatures. Median temperature was 35.55 degrees C [interquartile range (IR) 0.77 degrees C] in the external auditory channel (EAC) and 34.62 degrees C (IR 1.61) in the specified skin location. Median gradient between AEC and skin was 0.93 (IR 1.57). A circadian rhythm was present both in EAC and skin temperature, with a mean amplitude of 0.44 degrees C and an acrophase at 21:02 for the EAC and 0.70 degrees C and 00:42 for the skin. During the night there was a sizable increase in peripheral temperature, with a decrease in gradient and a loss of complexity in the temperature profile, most significantly in the peripheral temperature. Continuous monitoring of central and peripheral temperature may be a helpful tool in both ambulatory and admitted patients and may offer new approaches in clinical thermometry.

[Atypical sinus node dysfunction. Usefulness of implantable Holter. A case report].

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Martí Almor, J; Delclòs Urgell, J; Bruguera Cortada, J

2001-12-01

We present an 84 year-old female patient with repeated syncopes/presyncopes in the last nine years. All diagnosis tests were negative, including ECG, 24-hour Holter, tilt table test and EP study. Therefore, a subcutaneous insertable loop recorder was implanted (Reveal). The recording of three episodes showed the association of presyncope with the onset of atrial fibrilation and, in two syncopes, with an atrial pause between AF episodes. Probably an abnormal prolonged sinus node recovery time (more than 6 s) allowed AF to restart before the sinus rhythm.

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

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

2017-10-25

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

Effects of atomoxetine on heart rhythm in children and adolescents.

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Tanidir, Ibrahim Cansaran; Tanidir, Canan; Ozturk, Erkut; Bahali, Kayhan; Gunes, Hatice; Ergul, Yakup; Uneri, Ozden Sukran; Akdeniz, Celal; Tuzcu, Volkan

2015-12-01

The aim of this study was to examine the effects of atomoxetine on heart rhythm using 12-lead electrocardiography (ECG) and 24 h Holter monitoring. Children and adolescents who were diagnosed with attention deficit-hyperactivity disorder according to DSM-IV-TR were referred to a pediatric cardiology clinic for cardiologic examination before and after 4 or 5 weeks of atomoxetine treatment. Cardiac examination, complete blood count, biochemistry, thyroid function tests, 12-lead ECG and 24 h Holter monitoring were performed routinely in all patients. Each subject underwent 24 h Holter ECG monitoring before atomoxetine was started and after 4 or 5 weeks of effective dose atomoxetine treatment. Forty-one patients were included in this prospective study. No statistically significant change was found in QT, QTc or QT interval dispersion or blood pressure before and after 4 or 5 weeks of atomoxetine treatment. There was a statistically significant increase in heart rate (both during the day and at night) and QRS duration, and a statistically significant decrease in P wave dispersion. Three patients had rhythm disturbances. All of these three patients were asymptomatic and none of these arrhythmias reached clinical significance. Atomoxetine did not cause significant changes in ECG or Holter variables. In two patients, who had undiagnosed subclinical extrasystoles, extra beats were increased after 4th week of treatment, but still remained clinically insignificant. Before and after atomoxetine treatment, listening to the heart sounds for a longer time, may help clinicians to notice an extra beat. If an extra beat is identified then 24 Holter monitoring is recommended. © 2015 Japan Pediatric Society.

Multimodality assessment of cardiac involvement in Churg-Strauss syndrome patients in clinical remission

International Nuclear Information System (INIS)

Szczeklik, W.; Miszalski-Jamka, T.; Mastalerz, L.; Sokolowska, B.; Dropinski, J.; Musial, J.; Banys, R.; Hor, K.N.; Mazur, W.

2011-01-01

Cardiac involvement in Churg-Strauss syndrome (CSS) is not uncommon, but its frequency varies widely and may depend on the activity of the disease. Therefore, the cardiac involvement in CSS patients in clinical remission was assessed in the present study. In 20 CSS patients in remission and 20 sex- and age-matched healthy controls, an electrocardiogram (ECG) stress test, echocardiography, and 24-h ECG Holter monitoring were performed, together with cardiac magnetic resonance imaging (cMRI). Cardiac involvement was present in 90% (18/20) of CSS patients. Left ventricular ejection fraction (LVEF) was on average lower in the CSS group than in controls (P<0.05), with 7 patients showing systolic heart failure (LVEF <50%). cMRI changes included late gadolinium enhancement lesions in the LV in 89% of patients (17/19), present in all layers of the myocardium. Signs of ongoing inflammation (early gadolinium enhancement) and edema (T2-weighted imaging) were present in 6/19 patients. Holter monitoring revealed both supraventricular and ventricular arrhythmias more frequently in CSS patients when compared with controls (P<0.05). Absolute eosinophil count before the initiation of treatment was higher in rhythm disturbances (P<0.05), and inversely correlated with LV systolic function (rho -0.65). Heart involvement in CSS patients who are in clinical remission is very common. It is characterized not only by fibrosis, but also by an active inflammatory process. The latter finding might influence therapeutic decisions in CSS patients in full clinical remission. (author)

Multimodality assessment of cardiac involvement in Churg-Strauss syndrome patients in clinical remission

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Szczeklik, W; Miszalski-Jamka, T; Mastalerz, L; Sokolowska, B; Dropinski, J; Musial, J [Medical Coll., Jagiellonian Univ., Krakow (Poland); Banys, R [John Paul II Hospital, Krakow (Poland); Hor, K N [Cincinnati Children' s Medical Center, OH (United States); Mazur, W [Heart and Vascular Center at The Christ Hospitals, OH (United States)

2011-02-15

Cardiac involvement in Churg-Strauss syndrome (CSS) is not uncommon, but its frequency varies widely and may depend on the activity of the disease. Therefore, the cardiac involvement in CSS patients in clinical remission was assessed in the present study. In 20 CSS patients in remission and 20 sex- and age-matched healthy controls, an electrocardiogram (ECG) stress test, echocardiography, and 24-h ECG Holter monitoring were performed, together with cardiac magnetic resonance imaging (cMRI). Cardiac involvement was present in 90% (18/20) of CSS patients. Left ventricular ejection fraction (LVEF) was on average lower in the CSS group than in controls (P<0.05), with 7 patients showing systolic heart failure (LVEF <50%). cMRI changes included late gadolinium enhancement lesions in the LV in 89% of patients (17/19), present in all layers of the myocardium. Signs of ongoing inflammation (early gadolinium enhancement) and edema (T2-weighted imaging) were present in 6/19 patients. Holter monitoring revealed both supraventricular and ventricular arrhythmias more frequently in CSS patients when compared with controls (P<0.05). Absolute eosinophil count before the initiation of treatment was higher in rhythm disturbances (P<0.05), and inversely correlated with LV systolic function (rho -0.65). Heart involvement in CSS patients who are in clinical remission is very common. It is characterized not only by fibrosis, but also by an active inflammatory process. The latter finding might influence therapeutic decisions in CSS patients in full clinical remission. (author)

Predictive value of casual ECG-based resting heart rate compared with resting heart rate obtained from Holter recording

DEFF Research Database (Denmark)

Carlson, Nicholas; Dixen, Ulrik; Marott, Jacob L

2014-01-01

BACKGROUND: Elevated resting heart rate (RHR) is associated with cardiovascular mortality and morbidity. Assessment of heart rate (HR) from Holter recording may afford a more precise estimate of the effect of RHR on cardiovascular risk, as compared to casual RHR. Comparative analysis was carried ...

Development of an algorithm for heartbeats detection and classification in Holter records based on temporal and morphological features

International Nuclear Information System (INIS)

García, A; Romano, H; Laciar, E; Correa, R

2011-01-01

In this work a detection and classification algorithm for heartbeats analysis in Holter records was developed. First, a QRS complexes detector was implemented and their temporal and morphological characteristics were extracted. A vector was built with these features; this vector is the input of the classification module, based on discriminant analysis. The beats were classified in three groups: Premature Ventricular Contraction beat (PVC), Atrial Premature Contraction beat (APC) and Normal Beat (NB). These beat categories represent the most important groups of commercial Holter systems. The developed algorithms were evaluated in 76 ECG records of two validated open-access databases 'arrhythmias MIT BIH database' and M IT BIH supraventricular arrhythmias database . A total of 166343 beats were detected and analyzed, where the QRS detection algorithm provides a sensitivity of 99.69 % and a positive predictive value of 99.84 %. The classification stage gives sensitivities of 97.17% for NB, 97.67% for PCV and 92.78% for APC.

Syncope During Competitive Events: Interrogating Heart Rate Monitor Watches May Be Useful!

Science.gov (United States)

Thabouillot, Oscar; Bostanci, Kevin; Bouvier, Francois; Dumitrescu, Nicolae; Stéfuriac, Maria; Paule, Philippe; Roche, Nicolas-Charles

2017-12-01

This is a case report of a 45-year-old man who reported complete amnesia during the very first kilometer of a 10-km run. He was wearing a heart rate monitor (HRM). The interrogation of his HRM watch showed 200 bpm tachycardia beginning in the first kilometer and increasing up to 220 bpm during the last kilometer. The patient was asked to wear a Holter-monitor (Holter Research Laboratory; Helena, Montana USA) electrocardiogram (ECG) while practicing a training session. This examination allowed for the diagnosis of an adrenergic paroxysmal atrial fibrillation (AF) with an impressive auriculo-ventricular conduction over 260 bpm. This case highlights that non-medical devices, such as connected watches, can be helpful to diagnose arrhythmias. Thabouillot O , Bostanci K , Bouvier F , Dumitrescu N , Stéfuriac M , Paule P , Roche NC . Syncope during competitive events: interrogating heart rate monitor watches may be useful! Prehosp Disaster Med. 2017;32(6):691-693.

An Interoperable System toward Cardiac Risk Stratification from ECG Monitoring

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Cristina Soguero-Ruiz

2018-03-01

Full Text Available Many indices have been proposed for cardiovascular risk stratification from electrocardiogram signal processing, still with limited use in clinical practice. We created a system integrating the clinical definition of cardiac risk subdomains from ECGs and the use of diverse signal processing techniques. Three subdomains were defined from the joint analysis of the technical and clinical viewpoints. One subdomain was devoted to demographic and clinical data. The other two subdomains were intended to obtain widely defined risk indices from ECG monitoring: a simple-domain (heart rate turbulence (HRT, and a complex-domain (heart rate variability (HRV. Data provided by the three subdomains allowed for the generation of alerts with different intensity and nature, as well as for the grouping and scrutinization of patients according to the established processing and risk-thresholding criteria. The implemented system was tested by connecting data from real-world in-hospital electronic health records and ECG monitoring by considering standards for syntactic (HL7 messages and semantic interoperability (archetypes based on CEN/ISO EN13606 and SNOMED-CT. The system was able to provide risk indices and to generate alerts in the health records to support decision-making. Overall, the system allows for the agile interaction of research and clinical practice in the Holter-ECG-based cardiac risk domain.

An Interoperable System toward Cardiac Risk Stratification from ECG Monitoring

Science.gov (United States)

Mora-Jiménez, Inmaculada; Ramos-López, Javier; Quintanilla Fernández, Teresa; García-García, Antonio; Díez-Mazuela, Daniel; García-Alberola, Arcadi

2018-01-01

Many indices have been proposed for cardiovascular risk stratification from electrocardiogram signal processing, still with limited use in clinical practice. We created a system integrating the clinical definition of cardiac risk subdomains from ECGs and the use of diverse signal processing techniques. Three subdomains were defined from the joint analysis of the technical and clinical viewpoints. One subdomain was devoted to demographic and clinical data. The other two subdomains were intended to obtain widely defined risk indices from ECG monitoring: a simple-domain (heart rate turbulence (HRT)), and a complex-domain (heart rate variability (HRV)). Data provided by the three subdomains allowed for the generation of alerts with different intensity and nature, as well as for the grouping and scrutinization of patients according to the established processing and risk-thresholding criteria. The implemented system was tested by connecting data from real-world in-hospital electronic health records and ECG monitoring by considering standards for syntactic (HL7 messages) and semantic interoperability (archetypes based on CEN/ISO EN13606 and SNOMED-CT). The system was able to provide risk indices and to generate alerts in the health records to support decision-making. Overall, the system allows for the agile interaction of research and clinical practice in the Holter-ECG-based cardiac risk domain. PMID:29494497

Electrocardiographic Patch Devices and Contemporary Wireless Cardiac Monitoring

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Erik eFung

2015-05-01

Full Text Available Cardiac electrophysiologic derangements often coexist with disorders of the circulatory system. Capturing and diagnosing arrhythmias and conduction system disease may lead to a change in diagnosis, clinical management and patient outcomes. Standard 12-lead electrocardiogram (ECG, Holter monitors and event recorders have served as useful diagnostic tools over the last few decades. However, their shortcomings are only recently being addressed by emerging technologies. With advances in device miniaturization and wireless technologies, and changing consumer expectations, wearable ‘on-body’ ECG patch devices have evolved to meet contemporary needs. These devices are unobtrusive and easy to use, leading to increased device wear time and diagnostic yield. While becoming the standard for detecting arrhythmias and conduction system disorders in the outpatient setting where continuous ECG monitoring in the short to medium term (days to weeks is indicated, these cardiac devices and related digital mobile health technologies are reshaping the clinician-patient interface with important implications for future healthcare delivery.

Holter con memorias SD y sistema experto de evaluación cardíaca

OpenAIRE

Pfarher, Iván; Reula, Germán; Tovorosky, Pablo; Zanin, Miguel; Caballero, Raúl M.; Maggiolo, Gustavo Daniel

2006-01-01

Este desarrollo se enmarca dentro de las actividades de la cátedra de Técnicas Digitales de Ingeniería en Electrónica en UTN-FRP y tiene como objeto potenciar la capacidad de diseño de los alumnos. En este caso se ha desarrollado un sistema holter utilizando memorias SD comunes en el mercado de las cámaras fotográficas implementando además un sistema ordenador de control a partir del uso de un microcontrolador con el sistema de operación y de captura embebido correspondiente para la captura, ...

Ambulatory monitoring of myocardial ischemia in the 21st century-an opportunity for high frequency QRS analysis

Czech Academy of Sciences Publication Activity Database

Leinveber, Pavel; Halámek, Josef; Jurák, Pavel

2016-01-01

Roč. 49, č. 6 (2016), s. 902-906 ISSN 0022-0736 R&D Projects: GA MŠk(CZ) LO1212; GA MŠk ED0017/01/01 Institutional support: RVO:68081731 Keywords : ambulatory monitoring * HF-QRS * myocardial Ischemia * silent Ischemia * Holter monitoring Subject RIV: FA - Cardiovascular Diseases incl. Cardiotharic Surgery Impact factor: 1.514, year: 2016

The Telemetric and Holter ECG Warehouse Initiative (THEW): a Data Repository for the Design, Implementation and Validation of ECG-related Technologies

Science.gov (United States)

Couderc, Jean-Philippe

2011-01-01

We present an initiative supported by the National Heart Lung, and Blood Institute and the Food and Drug Administration for the development of a repository containing continuous electrocardiographic information to be shared with the worldwide scientific community. We believe that sharing data reinforces open scientific inquiry. It encourages diversity of analysis and opinion while promoting new research and facilitating the education of new researchers. In this paper, we present the resources available in this initiative for the scientific community. We describe the set of ECG signals currently hosted and we briefly discuss the associated clinical information (medical history. Disease and study-specific endpoints) and software tools we propose. Currently, the repository contains more than 250GB of data from eight clinical studies including healthy individuals and cardiac patients. This data is available for the development, implementation and validation of technologies related to body-surface ECGs. To conclude, the Telemetric and Holter ECG Warehouse (THEW) is an initiative developed to benefit the scientific community and to advance the field of quantitative electrocardiography and cardiac safety. PMID:21097349

[Evaluation of the radiofrequency ablation effectiveness in patients with the Wolff-Parkinson-White syndrome].

Science.gov (United States)

Ushakov, I B; Ardashev, A V; Ardashev, V N; Voronkov, Iu I; Sharoĭko, M V; Akimova, O S

2012-01-01

A one-year prospective study involved 22 patients with the Wolff-Parkinson-White syndrome (WPW) and 20 healthy people. Means age of patients was 34.3 +/- 16.3 years. All 22 patients were successfully treated with radiofrequency ablation (RFA) of additional pathways. RFA effectiveness was evaluated with the help of clinical questionnaire, data of ECG, EchoCG, heart rate variability (HRV), frequency response and nonlinear dynamics. Cardiac rhythm disturbances were verified using Holter monitoring applied to all patients. Positive clinical effect was achieved in all the WPW patients, as RFA arrested cardiac arrhythmias completely. Holter monitoring did not register cardiac disturbances which points to high RFA effectiveness in WPW patients. HRV, frequency response and nonlinear dynamics reassumed their normal patterns.

Psicologia aplicada à cardiologia: um estudo sobre emoções relatadas em exame de holter

OpenAIRE

Bonomo, Ana Myriam Sánchez; Araujo, Tereza Cristina Cavalcanti Ferreira de

2009-01-01

Estudos sobre fatores de risco associados a doenças do coração dão ênfase às emoções negativas e não esclarecem quanto aos efeitos cardíacos de vivências de alegria ou segurança. Realizou-se uma investigação com 30 pessoas submetidas ao exame de Holter 24 horas, visando identificar emoções e episódios de vida diária que ocorrem simultaneamente a arritmias cardíacas. Reuniram-se registros de arritmias, atividades e emoções, complementados por entrevistas semiestruturadas. Verificaram-se difere...

Useful clinical features for the selection of ideal patients with strial fibrillation for mapping and catheter ablation

Directory of Open Access Journals (Sweden)

Mehta Niraj

2002-01-01

Full Text Available OBJECTIVE: To identify useful clinical characteristics for selecting patients eligible for mapping and ablation of atrial fibrillation. METHODS: We studied 9 patients with atrial fibrillation, without structural heart disease, associated with: 1 antiarrhythmic drugs, 2 symptoms of low cardiac output, and 3 intention to treat. Seven patients had paroxysmal atrial fibrillation and 2 had recurrent atrial fibrillation. RESULTS: In the 6 patients who underwent mapping (all had paroxysmal atrial fibrillation, catheter ablation was successfully carried out in superior pulmonary veins in 5 patients (the first 3 in the left superior pulmonary vein and the last 2 in the right superior pulmonary vein. One patient experienced a recurrence of atrial fibrillation after 10 days. We observed that patients who had short episodes of atrial fibrillation on 24-hour Holter monitoring before the procedure were those in whom mapping the focus of tachycardia was possible. Tachycardia was successfully suppressed in 4 of 6 patients. The cause of failure was due to the impossibility of maintaining sinus rhythm long enough for efficient mapping. CONCLUSION: Patients experiencing short episodes of atrial fibrillation during 24-hour Holter monitoring were the most eligible for mapping and ablation, with a final success rate of 66%, versus the global success rate of 44%. Patients with persistent atrial fibrillation were not good candidates for focal ablation.

Atrial Fibrillation Detection During 24-Hour Ambulatory Blood Pressure Monitoring: Comparison With 24-Hour Electrocardiography.

Science.gov (United States)

Kollias, Anastasios; Destounis, Antonios; Kalogeropoulos, Petros; Kyriakoulis, Konstantinos G; Ntineri, Angeliki; Stergiou, George S

2018-07-01

This study assessed the diagnostic accuracy of a novel 24-hour ambulatory blood pressure (ABP) monitor (Microlife WatchBP O3 Afib) with implemented algorithm for automated atrial fibrillation (AF) detection during each ABP measurement. One hundred subjects (mean age 70.6±8.2 [SD] years; men 53%; hypertensives 85%; 17 with permanent AF; 4 paroxysmal AF; and 79 non-AF) had simultaneous 24-hour ABP monitoring and 24-hour Holter monitoring. Among a total of 6410 valid ABP readings, 1091 (17%) were taken in ECG AF rhythm. In reading-to-reading ABP analysis, the sensitivity, specificity, and accuracy of ABP monitoring in detecting AF were 93%, 87%, and 88%, respectively. In non-AF subjects, 12.8% of the 24-hour ABP readings indicated false-positive AF, of whom 27% were taken during supraventricular premature beats. There was a strong association between the proportion of false-positive AF readings and that of supraventricular premature beats ( r =0.67; P ABP monitoring had 100%/85% sensitivity/specificity (area under the curve 0.91; P ABP monitor with AF detector has high sensitivity and moderate specificity for AF screening during routine ABP monitoring. Thus, in elderly hypertensives, a 24-hour ABP recording with at least 26% of the readings suggesting AF indicates a high probability for AF diagnosis and should be regarded as an indication for performing 24-hour Holter monitoring. © 2018 American Heart Association, Inc.

Smartphone electrographic monitoring for atrial fibrillation in acute ischemic stroke and transient ischemic attack.

Science.gov (United States)

Tu, Hans T; Chen, Ziyuan; Swift, Corey; Churilov, Leonid; Guo, Ruibing; Liu, Xinfeng; Jannes, Jim; Mok, Vincent; Freedman, Ben; Davis, Stephen M; Yan, Bernard

2017-10-01

Rationale Paroxysmal atrial fibrillation is a common and preventable cause of devastating strokes. However, currently available monitoring methods, including Holter monitoring, cardiac telemetry and event loop recorders, have drawbacks that restrict their application in the general stroke population. AliveCor™ heart monitor, a novel device that embeds miniaturized electrocardiography (ECG) in a smartphone case coupled with an application to record and diagnose the ECG, has recently been shown to provide an accurate and sensitive single lead ECG diagnosis of atrial fibrillation. This device could be used by nurses to record a 30-s ECG instead of manual pulse taking and automatically provide a diagnosis of atrial fibrillation. Aims To compare the proportion of patients with paroxysmal atrial fibrillation detected by AliveCor™ ECG monitoring with current standard practice. Sample size 296 Patients. Design Consecutive ischemic stroke and transient ischemic attack patients presenting to participating stroke units without known atrial fibrillation will undergo intermittent AliveCor™ ECG monitoring administered by nursing staff at the same frequency as the vital observations of pulse and blood pressure until discharge, in addition to the standard testing paradigm of each participating stroke unit to detect paroxysmal atrial fibrillation. Study outcome Proportion of patients with paroxysmal atrial fibrillation detected by AliveCor™ ECG monitoring compared to 12-lead ECG, 24-h Holter monitoring and cardiac telemetry. Discussion Use of AliveCor™ heart monitor as part of routine stroke unit nursing observation has the potential to be an inexpensive non-invasive method to increase paroxysmal atrial fibrillation detection, leading to improvement in stroke secondary prevention.

The Brugada syndrome. Outcome of one case

Directory of Open Access Journals (Sweden)

Maia Ivan G.

2000-01-01

Full Text Available The Brugada syndrome is a rare condition, and due to its mutating manner of presentation it may be difficult to diagnose. We report one case and discuss the diagnostic aspects and the clinical outcome of one patient with characteristic findings of this syndrome. These findings are especially defined by J-ST elevation in the right leads of serial electrocardiographic records, wide oscillations of J points and ST segments during 24-hour Holter monitoring, and nocturnal sudden death. We stress the importance of the Holter monitor findings for diagnostic complementation. Through this method it is possible to establish a correlation between vigil activities and sleep and the variability of the degree of impairment in ventricular repolarization.

Monitoring and Detection Platform to Prevent Anomalous Situations in Home Care

Directory of Open Access Journals (Sweden)

Gabriel Villarrubia

2014-06-01

Full Text Available Monitoring and tracking people at home usually requires high cost hardware installations, which implies they are not affordable in many situations. This study/paper proposes a monitoring and tracking system for people with medical problems. A virtual organization of agents based on the PANGEA platform, which allows the easy integration of different devices, was created for this study. In this case, a virtual organization was implemented to track and monitor patients carrying a Holter monitor. The system includes the hardware and software required to perform: ECG measurements, monitoring through accelerometers and WiFi networks. Furthermore, the use of interactive television can moderate interactivity with the user. The system makes it possible to merge the information and facilitates patient tracking efficiently with low cost.

Arrhythmias and conduction abnormalities in children after repair of tetralogy of Fallot

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Kuzevska-Maneva Konstandina

2005-01-01

Full Text Available Aim. To find out types and frequency of cardiac arrhythmias and conduction abnormalities in the group of children who underwent surgery for tetralogy of Fallot (TOF. Methods. Fortysix pedicatric patients who underwent a complete repair of TOF at the age of 1 to 13 (mean 2.89 ± 2.36 were studied. Thirty-eight (82.60% had total correction and 8 (17.40% had palliative operation first, and total correction afterwards. Twenty-four-hour Holter ECG monitoring was performed in all 46 pediatric patients aged from 1 to 16 yrs (mean 6.48 ± 4.04 after surgery as follows: in 1 patient (2.17% after a year, in 20 patients (43.47% after 2 to 5 years and in 25 patients (54.34% after 5 years. Mean age of patients on Holter monitoring was 9.25 ± 4.39 (range 4−19. Twenty of them (43.47% were girls and 28 (56.53% were boys. All the patients were evaluated by standard methods (clinical signs, clinical findings, ECG before surgery, ECG before Holter monitoring and 2D Doppler echocardiography. Results. Types of heart rhythm found out by Holter monitoring were: sinus nodus dysfunction in 1 child (2.17%, significant premature atrial contraction (PAC in 8 (17.39%, supraventricular paroxysmal tachycardia in 3 (6.53%, transient nodal rhythm in 2 (4.34%, premature ventricular contraction (PVC Lown grade I-III in 9 (19.56% and Lown grade IV in 2 (4.34, atrioventricular (AV block grade I in 2, right bundle branch block (RBBB in all 46 (100% and RBBB + left anterior hemiblock (LAH in 4 (8.96%. There was no presence of atrial flutter, ventricular tachycardia or complete AV block. None of them experienced sudden death. Using cross procedure statistical methods, it was found that all the patients with PVC had right ventricular dilatation. There was no relation of other types of arrhythmia found on Holter monitoring to the other parameters from echocardiography, neither to the other standard methods. Children did not need the pace-maker, but 36.95% of the them required

Monitorização eletrocardiográfica ambulatorial por 24-horas em cães com cardiomiopatia dilatada idiopática Twenty-four-hour ambulatory electrocardiographic monitoring in dogs with idiopathic dilated cardiomyopathy

Directory of Open Access Journals (Sweden)

F.L. Yamaki

2007-12-01

Full Text Available Caracterizou-se monitorização eletrocardiográfica ambulatorial por 24 horas (ou monitorização Holter em cães com cardiomiopatia dilatada idiopática, visando principalmente à detecção de arritmias ventriculares não detectadas pela eletrocardiografia convencional (de repouso. Para tanto, avaliaram-se 40 pacientes com diagnóstico de cardiomiopatia dilatada idiopática, por meio de exame físico e mensuração indireta da pressão arterial, além de exames eletrocardiográfico, ecocardiográfico, radiográfico de tórax e da monitorização Holter. Extra-sístoles ventriculares foram detectadas, por monitorização Holter, em 97,5% dos animais e taquicardia ventricular, em 45%. Não houve correlação entre o número de extra-sístoles ventriculares e a fração de encurtamento. Considerando as manifestações clínicas, apenas houve associação entre presença de taquicardia ventricular e histórico de síncopes. Conclui-se que a incidência de arritmias ventriculares em cães com cardiomiopatia dilatada idiopática é bastante alta, sendo a taquicardia ventricular relativamente freqüente, ocorrendo mais sob a forma não sustentada.This study aimed to characterize 24-hour ambulatory electrocardiographic monitoring (Holter monitoring in dogs with idiopathic dilated cardiomyopathy. Physical examination and indirect (Doppler blood pressure measurement, and also electrocardiography, thoracic radiography, echocardiography, and 24-hour ambulatory electrocardiographic exams were performed in 40 dogs with idiopathic dilated cardiomyopathy. Ventricular extrasystoles were detected in 97.5% of the animals, and ventricular tachycardia in 45%. No correlation between the number of ventricular extrasystoles and the shortening fraction was observed. Concerning the clinical symptoms, there was only association between the presence of ventricular tachycardia and past report of syncope. It was concluded that the incidence of ventricular arrhythmias is

Practical clinical tool to monitor dementia symptoms: the HABC-Monitor

Directory of Open Access Journals (Sweden)

Monahan PO

2012-06-01

Full Text Available Patrick O Monahan,1 Malaz A Boustani,1–3,6 Catherine Alder,2,3,6 James E Galvin,7 Anthony J Perkins,2,3 Patrick Healey,4 Azita Chehresa,5 Polly Shepard,8 Corby Bubp,8 Amie Frame,2,3 Chris Callahan1–3,61Indiana University School of Medicine, 2Indiana University Center for Aging Research, 3Regenstrief Institute Inc, 4St Vincent’s Health Network, 5Community Health Network, 6Wishard Health Services, Eskenazi Health, Indianapolis IN, 7Alzheimer Disease Center, Departments of Neurology and Psychiatry, New York University School of Medicine, New York, NY, 8Memory Clinic of Indianapolis, Indianapolis, IN, USABackground: Dementia care providers need a clinical assessment tool similar to the blood pressure cuff (sphygmomanometer used by clinicians and patients for managing hypertension. A “blood pressure cuff” for dementia would be an inexpensive, simple, user-friendly, easily standardized, sensitive to change, and widely available multidomain instrument for providers and informal caregivers to measure severity of dementia symptoms. The purpose of this study was to assess the reliability and validity of the Healthy Aging Brain Care Monitor (HABC-Monitor for measuring and monitoring the severity of dementia symptoms through caregiver reports.Methods: The first prototype of the HABC-Monitor was developed in collaboration with the Indianapolis Discovery Network for Dementia, which includes 200 members representing 20 disciplines from 20 local organizations, and an expert panel of 22 experts in dementia care and research. The HABC-Monitor has three patient symptom domains (cognitive, functional, behavioral/psychological and a caregiver quality of life domain. Patients (n = 171 and their informal caregivers (n = 171 were consecutively approached and consented during, or by phone shortly following, a patient’s routine visit to their memory care provider.Results: The HABC-Monitor demonstrated good internal consistency (0.73–0.92; construct validity

Perfil clínico de pacientes chagásicos e não-chagásicos portadores de marca-passo cardíaco artificial Clinical profile of Chagas and non-Chagas' disease patients with cardiac pacemaker

Directory of Open Access Journals (Sweden)

Leonor Garcia Rincon

2006-06-01

Full Text Available O objetivo do estudo foi comparar pacientes chagásicos e não-chagásicos com marca-passo cardíaco artificial uni ou bicameral quanto à fração de ejeção do ventrículo esquerdo, o limiar de estimulação ventricular e a incidência de arritmias cardíacas. Entre janeiro/2001 e novembro/2002 foram avaliados 45 pacientes chagásicos e 35 não-chagásicos portadores de marca-passo quanto à história clínica, radiografia do tórax, ecocardiograma, Holter 24h e análise telemétrica do marca-passo. Embora os chagásicos fossem mais jovens, os dois grupos foram semelhantes quanto a variáveis radiológicas e o limiar de estimulação ventricular direito. Os chagásicos apresentaram menor fração de ejeção do ventrículo esquerdo ao ecocardiograma e maior incidência de arritmia ventricular ao Holter 24h. Observou-se correlação positiva entre a baixa fração de ejeção do ventrículo esquerdo e a intensidade da arritmia ventricular ao Holter 24h. Em pacientes com marca-passo, a doença de Chagas está associada a marcadores cardíacos de prognóstico adverso.The aim of this study was to compare Chagas and non-Chagas' disease patients using single or dual-chamber pacemaker in relation to the ejection fraction of the left ventricle, the ventricular stimulation threshold and the occurrence of ventricular arrhythmia. From January, 2001 to November, 2002, 45 Chagas' disease patients and 35 non-Chagas' disease patients, all pacemaker users, were evaluated considering clinical history, echocardiographic study, Holter monitoring and analysis of the pacemaker telemetry data. Chagas' disease patients were significantly younger, but both groups were similar when chest X-Ray variables and right ventricular stimulation threshold were analyzed. Chagas' disease patients had a lower left ventricular ejection fraction and more frequent ventricular arrhythmia during Holter monitoring. A positive correlation between the low ejection fraction of the left

Using business intelligence to monitor clinical quality metrics.

Science.gov (United States)

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.

Cardiotoxicity in Asymptomatic Patients Receiving Adjuvant 5-fluorouracil

DEFF Research Database (Denmark)

Nielsen, Karin; Polk, Anne; Nielsen, Dorte Lisbet

2014-01-01

Evolving evidence of cardiotoxicity in cancer patients treated with 5-fluorouracil (5-FU) has been reported. We report two different clinical manifestations of asymptomatic 5-FU-associated cardiotoxicity in patients operated for colorectal cancer and treated with adjuvant chemotherapy of 5-FU...... (bolus-injection and continuous infusion for 46 hours), folinic acid and oxaliplatin (FOLFOX). For a research study evaluating cardiac events during 5-FU treatment, Holter monitoring, electrocardiogram (ECG) and echocardiography were done and cardiac markers monitored before and during the first...... and hyperlipidemia as well as an incidental finding of negative T-waves in electrocardiogram years before 5-FU treatment. No subjective cardiac symptoms were described during infusion, but approximately 12 hours after infusion she suffered from cardiac arrest but was revived. Subsequent analysis of the Holter...

Electro-resistive bands for non-invasive cardiac and respiration monitoring, a feasibility study

International Nuclear Information System (INIS)

Gargiulo, Gaetano D; Breen, Paul P; O’Loughlin, Aiden

2015-01-01

Continuous unobtrusive monitoring of tidal volume, particularly for critical care patients (i.e. neonates and patients in intensive care) during sleep studies and during daily activities, is still an unresolved monitoring need. Also a successful monitoring solution is yet to be proposed for continuous non-invasive cardiac stroke volume monitoring that is a novel clinical need. In this paper we present the feasibility study for a wearable, non-invasive, non-contact and unobtrusive sensor (embedded in a standard T-shirt) based on four electro-resistive bands that simultaneously monitors tidal volume and cardiac stroke volume changes. This low power sensor system (requires only 100 mW and accepts a wide power supply range up to ±18 V); thus the sensor can be easily embedded in existing wearable solutions (i.e. Holter monitors). Moreover, being contactless, it can be worn over bandages or electrodes, and as it does not rely over the integrity of the garment to work, it allows practitioners to perform procedures during monitoring. For this preliminary evaluation, one subject has worn the sensor over the period of 24 h (removing it only to shower); the accuracy of the tidal volume tested against a portable spirometer reported a precision of ±10% also during physical activity; accuracy tests for cardiac output (as it may require invasive procedure) have not been carried out in this preliminary trial. (note)

A Unique Digital Electrocardiographic Repository for the Development of Quantitative Electrocardiography and Cardiac Safety: The Telemetric and Holter ECG Warehouse (THEW)

Science.gov (United States)

Couderc, Jean-Philippe

2010-01-01

The sharing of scientific data reinforces open scientific inquiry; it encourages diversity of analysis and opinion while promoting new research and facilitating the education of next generations of scientists. In this article, we present an initiative for the development of a repository containing continuous electrocardiographic information and their associated clinical information. This information is shared with the worldwide scientific community in order to improve quantitative electrocardiology and cardiac safety. First, we present the objectives of the initiative and its mission. Then, we describe the resources available in this initiative following three components: data, expertise and tools. The Data available in the Telemetric and Holter ECG Warehouse (THEW) includes continuous ECG signals and associated clinical information. The initiative attracted various academic and private partners whom expertise covers a large list of research arenas related to quantitative electrocardiography; their contribution to the THEW promotes cross-fertilization of scientific knowledge, resources, and ideas that will advance the field of quantitative electrocardiography. Finally, the tools of the THEW include software and servers to access and review the data available in the repository. To conclude, the THEW is an initiative developed to benefit the scientific community and to advance the field of quantitative electrocardiography and cardiac safety. It is a new repository designed to complement the existing ones such as Physionet, the AHA-BIH Arrhythmia Database, and the CSE database. The THEW hosts unique datasets from clinical trials and drug safety studies that, so far, were not available to the worldwide scientific community. PMID:20863512

Effects of citalopram on heart rate variability in women with generalized anxiety disorder

Directory of Open Access Journals (Sweden)

Fatemeh Ranjbar

2015-07-01

Full Text Available BACKGROUND: Heart rate variability (HRV is defined as variations in R-R interval with time. Dysautonomia is common in patients with psychiatric disorders such as depression and anxiety. Using HRV analysis, recent studies showed that in anxiety disorders, the vagal cardiac function decreases, and sympathetic function increases. This study aimed at investigating citalopram effects on HRV. METHODS: This before and after study was conducted in 25 generalized anxiety disorder (GAD patients. GAD was diagnosed based on clinical interview according to diagnostic and statistical manual of mental disorders IV-Text revised (DSM-IV-TR criteria using Structured Clinical Interview for DSM Disorders-I questionnaire. A cardiologist studied 24 h ambulatory monitoring of the electrocardiogram (Holter on all patients before the treatment. A volume of 20 mg of citalopram was administered to the subjects on a daily basis. Then, they were studied by Holter monitoring again after 1-month of administration of citalopram. RESULTS: The average age of participants was 35.32 ± 8.7. The average Holter monitoring time was 23.29 ± 1.14 h before treatment and 23.81 ± 0.68 after it. The 3 h low frequency/high frequency ratio was significantly different between 3 h segments of time before treatment (P < 0.001. This difference was even higher after treatment (P = 0.001. Data showed an increase in parasympathetic tone during sleep both before and after treatment. CONCLUSION: These patients showed some impairments of HRV indices that did not improve by citalopram in future, the clinical importance of such disturbances should be evaluated in details with prolonged follow-up and greater sample size.   

Recomendações da sociedade brasileira de arritmias cardíacas para serviços de holter

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Adalberto Lorga Filho

2013-08-01

Full Text Available FUNDAMENTOS: Inúmeros indicadores são utilizados para assegurar a qualidade de um serviço; entretanto, a competência médica e o adequado fluxo de realização de um procedimento são determinantes da qualidade final. Nesse contexto, a Sociedade Brasileira de Arritmias Cardíacas pretende recomendar parâmetros mínimos necessários para garantir a excelência dos serviços de monitorização eletrocardiográfica ambulatorial. OBJETIVOS: Recomendar competências médicas mínimas e as informações necessárias para emissão do laudo de Holter. MÉTODOS: O documento foi fundamentado no conceito de medicina baseada em evidência, e nas circunstâncias em que a evidência não estava disponível a opinião de uma comissão de redação foi utilizada para a formulação da recomendação. Essa comissão foi formada por profissionais que apresentam vivência nas dificuldades do método e gestão na prestação de serviços nessa área. RESULTADOS: O profissional responsável pela análise de Holter deve conhecer as patologias cardiovasculares e ter formação consistente em eletrocardiografia, incluindo arritmias cardíacas e seus diagnósticos diferenciais. O laudo deve ser redigido de forma clara e objetiva. Os parâmetros mínimos que devem constar no laudo incluem as estatísticas do exame, assim como quantificação e análise dos distúrbios do ritmo observados durante a monitorização. CONCLUSÃO: A monitorização eletrocardiográfica ambulatorial deve ser realizada por profissionais com vivência em análise eletrocardiográfica e o laudo deve conter os parâmetros mínimos mencionados nesse documento.

Tools for monitoring spondyloarthritis in clinical practice

NARCIS (Netherlands)

van Tubergen, Astrid M.; Landewé, Robert B. M.

2009-01-01

Spondyloarthritis (SpA) usually follows a chronic disease course that requires regular medical care and monitoring to control for increased disease activity and to maintain physical function. This Review describes the instruments and imaging techniques available for monitoring SpA in clinical

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

Science.gov (United States)

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 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.

Psicologia aplicada à cardiologia: um estudo sobre emoções relatadas em exame de holter

Directory of Open Access Journals (Sweden)

Ana Myriam Sánchez Bonomo

Full Text Available Estudos sobre fatores de risco associados a doenças do coração dão ênfase às emoções negativas e não esclarecem quanto aos efeitos cardíacos de vivências de alegria ou segurança. Realizou-se uma investigação com 30 pessoas submetidas ao exame de Holter 24 horas, visando identificar emoções e episódios de vida diária que ocorrem simultaneamente a arritmias cardíacas. Reuniram-se registros de arritmias, atividades e emoções, complementados por entrevistas semiestruturadas. Verificaram-se diferenças acentuadas entre gêneros: mulheres apresentaram mais arritmias que homens. Nas mulheres, arritmias ventriculares ocorreram mais simultaneamente à preocupação do que à ansiedade e não se mostraram relacionadas à raiva. A tristeza não foi associada a arritmias ventriculares por nenhum dos gêneros.

Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors.

Science.gov (United States)

Pürerfellner, Helmut; Sanders, Prashanthan; Sarkar, Shantanu; Reisfeld, Erin; Reiland, Jerry; Koehler, Jodi; Pokushalov, Evgeny; Urban, Luboš; Dekker, Lukas R C

2017-10-03

Intermittent change in p-wave discernibility during periods of ectopy and sinus arrhythmia is a cause of inappropriate atrial fibrillation (AF) detection in insertable cardiac monitors (ICM). To address this, we developed and validated an enhanced AF detection algorithm. Atrial fibrillation detection in Reveal LINQ ICM uses patterns of incoherence in RR intervals and absence of P-wave evidence over a 2-min period. The enhanced algorithm includes P-wave evidence during RR irregularity as evidence of sinus arrhythmia or ectopy to adaptively optimize sensitivity for AF detection. The algorithm was developed and validated using Holter data from the XPECT and LINQ Usability studies which collected surface electrocardiogram (ECG) and continuous ICM ECG over a 24-48 h period. The algorithm detections were compared with Holter annotations, performed by multiple reviewers, to compute episode and duration detection performance. The validation dataset comprised of 3187 h of valid Holter and LINQ recordings from 138 patients, with true AF in 37 patients yielding 108 true AF episodes ≥2-min and 449 h of AF. The enhanced algorithm reduced inappropriately detected episodes by 49% and duration by 66% with adapts sensitivity for AF detection reduced inappropriately detected episodes and duration with minimal reduction in sensitivity. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Cardiology

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

Science.gov (United States)

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

Multiparametric monitoring of tissue vitality in clinical situations

Science.gov (United States)

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

2001-05-01

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

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

Science.gov (United States)

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.

Journal of Clinical Monitoring and Computing 2015 end of year summary : cardiovascular and hemodynamic monitoring

NARCIS (Netherlands)

Bendjelid, Karim; Rex, Steffen; Scheeren, Thomas; Saugel, Bernd

Hemodynamic monitoring is essential in critically ill patients. In this regard, the Journal of Clinical Monitoring and Computing (JCMC) has become an ideal platform for publishing cardiovascular and hemodynamic monitoring-related research, as reflected by an increasing number of articles related to

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

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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

Ambulatory monitoring of blood pressure and pregnancy outcome in pregnant women with white coat hypertension in the third trimester of pregnancy.

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Shahbazian, Nahid; Shahbazian, Heshmatollah; Mohammadjafari, Razieh; Mousavi, Mahsan

2013-01-01

Introduction: If the blood pressure of a pregnant woman is ≥140/90 mmHg at the clinic, but her ambulatory blood pressure is less coat hypertension. Objectives: To evaluate the value of ambulatory blood pressure monitoring in pregnant women. Patients and Methods: This prospective cohort study was conducted in Imam-Khomeini hospital of Ahwaz, Iran between 2011 to 2012. A total of 105 pregnant women who had blood pressure of higher than 140/90 mmHg during the third trimester of pregnancy were monitored. Thirty five women with white coat hypertension, 35 women with gestational hypertension and 35 women with normal blood pressure were followed. The data were analyzed using the Kolmogorov-Smirnov test, Pearson correlation coefficient and Chi-square tests. Results: The prevalence of white coat hypertension was 31.3%. The maternal and neonatal outcomes and laboratory examinations in white coat hypertension were similar to the normal blood pressure, but the frequency of caesarean section was more than the other two groups. Conclusion: The findings of the study indicate the efficacy of 24 hour holter monitoring of blood pressure and using it more comprehensively , compared to the limited visits.

Biosensors and invasive monitoring in clinical applications

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Córcoles, Emma P

2013-01-01

This volume examines the advances of invasive monitoring by means of biosensors and microdialysis. Physical and physiological parameters are commonly monitored in clinical settings using invasive techniques due to their positive outcome in patients’ diagnosis and treatment. Biochemical parameters, however, still rely on off-line measurements and require large pieces of equipment. Biosensing and sampling devices present excellent capabilities for their use in continuous monitoring of patients’ biochemical parameters. However, certain issues remain to be solved in order to ensure a more widespread use of these techniques in today’s medical practices.

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

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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

Radiation dose monitoring in the clinical routine

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Guberina, Nika [UK Essen (Germany). Radiology

2017-04-15

Here we describe the first clinical experiences regarding the use of an automated radiation dose management software to monitor the radiation dose of patients during routine examinations. Many software solutions for monitoring radiation dose have emerged in the last decade. The continuous progress in radiological techniques, new scan features, scanner generations and protocols are the primary challenge for radiation dose monitoring software systems. To simulate valid dose calculations, radiation dose monitoring systems have to follow current trends and stay constantly up-to-date. The dose management software is connected to all devices at our institute and conducts automatic data acquisition and radiation dose calculation. The system incorporates 18 virtual phantoms based on the Cristy phantom family, estimating doses in newborns to adults. Dose calculation relies on a Monte Carlo simulation engine. Our first practical experiences demonstrate that the software is capable of dose estimation in the clinical routine. Its implementation and use have some limitations that can be overcome. The software is promising and allows assessment of radiation doses, like organ and effective doses according to ICRP 60 and ICRP 103, patient radiation dose history and cumulative radiation doses. Furthermore, we are able to determine local diagnostic reference doses. The radiation dose monitoring software systems can facilitate networking between hospitals and radiological departments, thus refining radiation doses and implementing reference doses at substantially lower levels.

BioMEMS for multiparameter clinical monitoring

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Moser, Isabella

2003-01-01

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

Bedside identification of patients at risk for PVC-induced cardiomyopathy: Is ECG useful?

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Garster, Noelle C; Henrikson, Charles A

2017-07-01

Premature ventricular complexes (PVCs) are an underrecognized cause of cardiomyopathy. Standard 12-lead electrocardiogram (ECG) has potential to direct attention toward at-risk patients. We performed a single-center, retrospective chart review of 1,240 patients who completed ECG and Holter monitoring at Oregon Health and Science University Hospital between January 1, 2011 and December 31, 2013 to investigate the relationship of PVC frequency on ECG with burden on Holter. Primary outcome measures included PVC quantity on ECG, mean PVC quantity on Holter, and percentage of total beats on Holter recorded as PVCs. High PVC burden was defined as ≥10% of total beats. Weighted mean percentages of total beats on Holter monitor recorded as PVCs were calculated for 0, 1, 2, and ≥3 PVCs on ECG and found to be 1.4% (n = 1,128), 3.5% (n = 32), 4.3% (n = 25), and 16.6% (n = 55), respectively, which represent statistically significant differences (P ECG for ≥10% PVC Holter burden was 58%. Negative predictive value for 0 PVCs on ECG was 98%. The sensitivity and specificity of ECG to identify high PVC burden on Holter was 72% and 93.6%, respectively, when utilizing a positive ECG result as one PVC or more, and 44% and 98.9%, respectively, with ≥3 PVCs on ECG. The positive likelihood ratio corresponding to ≥3 PVCs on ECG was 40. These findings demonstrate that the number of PVCs on ECG can be utilized for quick bedside estimation of high PVC burden. © 2017 Wiley Periodicals, Inc.

Ambulatory Blood Pressure Monitoring – Clinical Practice Recommendations

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Katalin Mako

2016-09-01

Full Text Available Ambulatory blood pressure monitoring (ABPM became a subject of considerable scientific interest. Due to the increasing use of the ABPM in everyday clinical practice it is important that all the users have a correct knowledge on the clinical indications, the methodology of using the device including some technical issues and the interpretation of results. In the last years several guidelines and position papers have been published with recommendations for the monitoring process, reference values, for clinical practice and research. This paper represents a summary of the most important aspects related to the use of ABPM in daily practice, being a synthesis of recommendations from the recent published guidelines and position papers. This reference article presents the practical and technical issues of ABPM, the use of this method in special situations, the clinical interpretation of measured values including the presentation of different ABPM patterns, derived parameters, the prognostic significance and the limitations of this method.

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

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Zheng Hui

2009-12-01

Full Text Available Abstract 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.

Use of electronic monitoring in clinical nursing research.

Science.gov (United States)

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

2008-05-01

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

Comparison of two systems for long-term heart rate variability monitoring in free-living conditions - a pilot study

DEFF Research Database (Denmark)

Kristiansen, Jesper; Korshoj, Mette; Skotte, Jorgen H

2011-01-01

Actiheart and Holter recorders, and signals were processed to RR-interval time series. Segments of 5-minute duration were sampled every 30 minutes, and spectral components of the heart rate variability were calculated. Actiheart and Holter values were compared using Deming regression analysis and Bland...

Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring

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Fegert Joerg M

2008-09-01

Full Text Available Abstract The review presents pediatric adverse drug events from a historical perspective and focuses on selected safety issues associated with off-label use of medications for the psychiatric treatment of youth. Clinical monitoring procedures for major psychotropic drug classes are reviewed. Prior studies suggest that systematic treatment monitoring is warranted so as to both minimize risk of unexpected adverse events and exposures to ineffective treatments. Clinical trials to establish the efficacy and safety of drugs currently being used off-label in the pediatric population are needed. In the meantime, clinicians should consider the existing evidence-base for these drugs and institute close clinical monitoring.

[Limits of cardiac functional adaptation in "top level" resistance athletes].

Science.gov (United States)

Carù, B; Righetti, G; Bossi, M; Gerosa, C; Gazzotti, G; Maranetto, D

2001-02-01

Sports activity, particularly when performed at high level, provokes cardiovascular adjustments depending on the type of sport and on the level of the load. We evaluated 15 athletes from the Italian national team during a non-agonistic period of cross country skiing, with non-invasive tests including exercise test, color Doppler echocardiography, Holter monitoring, physical examination and standard rest electrocardiogram. Physical examination, rest electrocardiogram, exercise testing and echocardiography were all within the range of the expected values for this type of subjects. Holter monitoring recorded during the periods of agonistic activity revealed significant hypokinetic arrhythmias such as severe bradycardia, pauses, I and II degree atrioventricular blocks, and complete atrioventricular block in 2 cases; these features were not observed on Holter monitoring recorded during the non-agonistic period. The perfect health status of subjects and their racing results may bring about physiological functional adjustments, but these observations suggest the need for a follow-up to evaluate possible pathologic outcomes.

Ambulatory Blood Pressure Monitoring in Clinical Practice: A Review

Science.gov (United States)

Viera, Anthony J.; Shimbo, Daichi

2016-01-01

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

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

OpenAIRE

Boyer, S.; March, L.; Kouanfack, C.; Laborde-Balen, G.; Marino, P.; Aghokeng Fobang, Avelin; Mpoudi-Ngole, E.; Koulla-Shiro, S.; Delaporte, Eric; Carrieri, M. P.; Spire, B.; Laurent, Christian; Moatti, Jean-Paul

2013-01-01

Background In low-income countries, the use of laboratory monitoring of patients taking antiretroviral therapy (ART) remains controversial in view of persistent resource constraints. The Stratall trial did not show that clinical monitoring alone was non-inferior to laboratory and clinical monitoring in terms of immunological recovery. We aimed to evaluate the costs and cost-effectiveness of the ART monitoring approaches assessed in the Stratall trial. Methods The randomised, controlled, non-i...

Clinical implications of increased use of MRI in TIA.

Science.gov (United States)

Kvistad, C E; Thomassen, L; Waje-Andreassen, U; Moen, G; Logallo, N; Naess, H

2013-07-01

Transient ischemic attack has been redefined as a tissue-based diagnosis and MRI recommended as the preferred imaging modality. We aimed to investigate whether an increased use of MRI leads to a decrease in the proportion of TIA as compared to cerebral infarction. We also sought to see whether DWI-positive patients with transient ischemic symptoms TIA patients in terms of performed diagnostic investigations and clinical characteristics. Patients admitted with cerebral infarction or TIA in the period 2006-2011 were prospectively registered. The use of MRI in patients with transient ischemic symptoms TIA were annually recorded. DWI-positive and DWI-negative patients with transient ischemic symptoms TIA as compared to cerebral infarction decreased from 12.2% in 2006-2008 to 8.3% in 2009-2011 (P = 0.002). DWI-positive patients were more often examined with 24-h Holter monitoring (P TIA definition resulted in a decrease in the proportion of TIA at discharge as compared to cerebral infarction. DWI-positive patients had a more extensive cardiac work-up and were associated with lower age and prior myocardial infarction. © 2012 John Wiley & Sons A/S.

The clinical practice of intraoperative neurophysiological monitoring in Shanghai Huashan Hospital

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WU Jin-song

2012-12-01

Full Text Available Intraoperative neurophysiological monitoring (IONM is the gold standard of the intraoperative functional brain mapping. It employs various electrophysiological methods such as awake craniotomy, intraoperative somatosensory and motor evoked potentials monitoring, intraoperative cortical stimulation and sub-cortical stimulation to accurately map the cortical and sub-cortical nervous pathways so that the continuous assessment and real -time protection of the functional integrity of certain neural structures can be achieved during surgery. Based on decades of clinical practice, the Department of Neurosurgery of Shanghai Huashan Hospital has set up an "IONM clinical practice guideline" used in the institute. The clinical practice guideline covers technical and operation standards of IONM in all kinds of common neurosurgery diseases and does improve the clinical efficacy in neurosurgical procedures.

Clinical implications from monitoring fetal activity.

Science.gov (United States)

Rayburn, W F

1982-12-15

The monitoring of fetal motion in high-risk pregnancies has been shown to be worthwhile in predicting fetal distress and impending fetal death. The maternal recording of perceived fetal activity is an inexpensive surveillance technique which is most useful when there is chronic uteroplacental insufficiency or when a stillbirth may be expected. The presence of an active, vigorous fetus is reassuring, but documented fetal inactivity required a reassessment of the underlying antepartum complication and further fetal evaluation with real-time ultrasonography, fetal heart rate testing, and biochemical testing. Fetal distress from such acute changes as abruptio placentae or umbilical cord compression may not be predicted by monitoring fetal motion. Although not used for routine clinical investigation, electromechanical devices such as tocodynamometry have provided much insight into fetal behavioral patterns at many stages of pregnancy and in pregnancies with an antepartum complication.

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

Science.gov (United States)

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

2015-01-01

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

Therapeutic drug monitoring in epilepsy clinic: a multi-disciplinary approach

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Sunee Lertsinudom

2014-12-01

Full Text Available Epilepsy is a common public health problem and needs multi-disciplinary treatment. Therapeutic drug monitoring (TDM is one of step of the multi-disciplinary treatment in epilepsy at Epilepsy clinic, Khon Kaen University (Thailand. The TDM service has been established since 2008. Here, we aimed to study the roles of TDM order and epilepsy control. This is a prospective descriptive study in which data collection was done from January 1 to December 31, 2010, the period when pharmacists took part in assessing the appropriateness in measurement and interpretation of TDM in order to provide suggestions for physicians. The 112 patients under study had an average age of 38.21±15.36 years; 254 samples were collected for therapeutic drug monitoring; phenytoin was submitted mostly for drug monitoring at 46.46%; 44.49% of sub-missions for drug level monitoring were made owing to a suspected sub-therapeutic level. Associations were found between reasons of sending samples for drug level monitoring and the measured drug levels, i.e., 66.67% of drug levels found was so low that they were undetectable in sample for patients’ compliance investigation and 38.94% of the drug levels were found to be sub-therapeutic as for the case where submission of samples was done because of suspected sub-therapeutic level, 40% of the cases were found to be in toxicity range in the cases with suspected over-therapeutic levels and monitoring levels, 58.25% were found to be within the therapeutic range. Pharmacists used the interpreted results in patients’ care by recommending physicians to monitor therapeutic drug closely, to adjust the dosage of drugs, and to recommend checking patients’ compliance in their use of drugs at 56.5, 38.9, and 4.3%, respectively. Physicians’ responses were found to be absolute follow, partial follow and not follow at 77.95, 11.03, and 7.48%, respectively. In conclusion, associations were found between reasons of TDM order and measured drug

Reproducibility for Heart Rate Variability Analysis during 6-Min Walk Test in Patients with Heart Failure and Agreement between Devices.

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Braga, Lays Magalhães; Prado, Gustavo Faibischew; Umeda, Iracema Ioco Kikuchi; Kawauchi, Tatiana Satie; Taboada, Adriana Marques Fróes; Azevedo, Raymundo Soares; Pereira Filho, Horacio Gomes; Grupi, César José; Souza, Hayala Cristina Cavenague; Moreira, Dalmo Antônio Ribeiro; Nakagawa, Naomi Kondo

2016-01-01

Heart rate variability (HRV) analysis is a useful method to assess abnormal functioning in the autonomic nervous system and to predict cardiac events in patients with heart failure (HF). HRV measurements with heart rate monitors have been validated with an electrocardiograph in healthy subjects but not in patients with HF. We explored the reproducibility of HRV in two consecutive six-minute walk tests (6MW), 60-minute apart, using a heart rate monitor (PolarS810i) and a portable electrocardiograph (called Holter) in 50 HF patients (mean age 59 years, NYHA II, left ventricular ejection fraction ~35%). The reproducibility for each device was analysed using a paired t-test or the Wilcoxon signed-rank test. Additionally, we assessed the agreement between the two devices based on the HRV indices at rest, during the 6MW and during recovery using concordance correlation coefficients (CCC), 95% confidence intervals and Bland-Altman plots. The test-retest for the HRV analyses was reproducible using Holter and PolarS810i at rest but not during recovery. In the second 6MW, patients showed significant increases in rMSSD and walking distance. The PolarS810i measurements had remarkably high concordance correlation [0.86Holter at rest, during 6MW and recovery. At higher rates, a small effect in increasing differences between Holter and Polar in R-R intervals was observed. In conclusion, our study showed good reproducibility of HRV at rest in two consecutive 6MW using Holter and PolarS810i. Additionally, PolarS810i produced good agreements in short-term HRV indices based on Holter simultaneous recordings at rest, during the 6MW and recovery in HF patients.

A CLINICAL CASE OF ACUTE ALLERGIC MYOCARDITIS SIMULATING MYOCARDIAL INFARCTION

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N. A. Shostak

2015-01-01

Full Text Available Objective: to describe a clinical case of evolving acute eosinophilic myocarditis simulating coronary heart disease. Subjects and methods. Patient B. aged 62 years was admitted to Intensive Care Unit Fifteen, N.I. Pirogov First Moscow City Clinical Hospital, by being transferred from Thailand with a referral diagnosis of acute myocardial infarction made on November 1, 2012, with complaints of pressing and aching heart pains. At a Phuket hospital, his electrocardiogram recorded atrial fibrillation; indirect cardiac massage, electric pulse therapy, and mechanical ventilation were performed. After being admitted to the N.I. Pirogov First Moscow City Clinical Hospital, the patient underwent examination: estimation of laboratory indicators over time, electrocardiography (ECG, echocardiography, Holter ECG monitoring, and myocardial scintigraphy. Results. The patient had a history of an allergic reaction as urticaria to the ingestion of fish products. His examination showed practically all diagnostic criteria for allergic myocarditis: hypereosinophilia (the admission level of eosinophils was 9% with their further normalization; the characteristic clinical presentation of myocarditis (pressing retrosternal pain; elevated levels of cardiac specific enzymes (creatinine phosphokinase-MB, lactate dehydrogenase, troponin T; ECG changes – myocardial hypokinesis in the acute period, followed by its pattern normalization. of the pattern. Myocardial scintigraphy (by taking into account the fact that the patient had had a new allergic reaction episode, the investigators decided not to perform coronary angiography revealed decreased radiopharmaceutical accumulation in the lower left ventricular wall in the right coronary arterial bed; perfusion remained in the other myocardial walls. Conclusion. This clinical case reflects the specific features of the course of and difficulties in the diagnosis of acute allergic myocarditis that, in most cases, has no specific

Linear mixed-effects models for central statistical monitoring of multicenter clinical trials

OpenAIRE

Desmet, L.; Venet, D.; Doffagne, E.; Timmermans, C.; BURZYKOWSKI, Tomasz; LEGRAND, Catherine; BUYSE, Marc

2014-01-01

Multicenter studies are widely used to meet accrual targets in clinical trials. Clinical data monitoring is required to ensure the quality and validity of the data gathered across centers. One approach to this end is central statistical monitoring, which aims at detecting atypical patterns in the data by means of statistical methods. In this context, we consider the simple case of a continuous variable, and we propose a detection procedure based on a linear mixed-effects model to detect locat...

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

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Aaron DeVries

Full Text Available 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

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

Science.gov (United States)

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

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

Science.gov (United States)

Day, Roger S

2010-02-01

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

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

Science.gov (United States)

Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

2016-02-01

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

QTc interval prolongation in HIV-infected patients: a case–control study by 24-hour Holter ECG recording

Directory of Open Access Journals (Sweden)

Fiorentini Alessandra

2012-12-01

Full Text Available Abstract Background Aim of the study was to assess QTc interval by a 24-hour ECG recording in a group of HIV-infected individuals with a basal prolonged QTc. The risk factors associated with QTc prolongation and the indices of cardiovascular autonomic control were also evaluated. Methods A case–control study was performed using as cases 32 HIV-infected patients with prolonged (>440 msec QTc interval as assessed by Holter ECG, and as controls 64 HIV-infected subjects with normal QTc interval. Autonomic function was evaluated by heart rate variability analysis during 24-hour recording. Results Duration of HIV disease was significantly longer among cases than among controls (p=0.04. Waist/hip ratio was also higher among cases than among controls (p=0.05. Frequency domain analysis showed the absence of physiologic decrease of low frequency (LF in the night period in both cases and controls. The LF night in cases showed a statistically significant reduction when compared with controls (p=0.007. Conclusions In our study group, QTc interval prolongation was associated with a longer duration of HIV infection and with a greater waist/hip ratio. HIV patients with QTc interval prolongation and with a longer duration of HIV infection were more likely to have an impairment of parasympathetic and sympathetic cardiac component.

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

International Nuclear Information System (INIS)

Ng, J. A.; Booth, J. T.; O’Brien, R. T.; Huang, C.-Y.; Keall, P. J.; Colvill, E.; Poulsen, P. R.

2014-01-01

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

Ventricular Repolarization Evaluation From Surface ECG for Identification of the Patients With Increased Myocardial Electrical Instability

National Research Council Canada - National Science Library

Lass, Jaanus

2001-01-01

In order to reveal the possible correlation between the level of myocardial electrical instability assessed at Holter monitoring and certain ECG parameters characterizing ventricular repolarization...

The clinical utility of ambulatory blood pressure monitoring (ABPM): a review.

Science.gov (United States)

Harianto, Harry; Valente, Michael; Hoetomo, Soenarno; Anpalahan, Mahesan

2014-01-01

The current evidence suggests that ambulatory blood pressure monitoring (ABPM) should be an integral part of the diagnosis and management of hypertension. However, its uptake in routine clinical practice has been variable. This paper reviews the current evidence for the role of ABPM in clinical practice, including in hypotensive disorders and in specific comorbidities. It further discusses the clinical significance of abnormal ambulatory blood pressure patterns and hypertensive syndromes such as white coat, masked and resistant hypertension.

Benefit of general anesthesia monitored by bispectral index compared with monitoring guided only by clinical parameters. Systematic review and meta-analysis

Directory of Open Access Journals (Sweden)

Carlos Rogério Degrandi Oliveira

Full Text Available Abstract Background: The bispectral index parameter is used to guide the titration of general anesthesia; however, many studies have shown conflicting results regarding the benefits of bispectral index monitoring. The objective of this systematic review with meta-analysis is to evaluate the clinical impact of monitoring with the bispectral index parameter. Methods: The search for evidence in scientific information sources was conducted during December 2013 to January 2015, the following primary databases: Medline/PubMed, LILACS, Cochrane, CINAHL, Ovid, SCOPUS and TESES. The criteria for inclusion in the study were randomized controlled trials, comparing general anesthesia monitored, with bispectral index parameter with anesthesia guided solely by clinical parameters, and patients aged over 18 years. The criteria for exclusion were studies involving anesthesia or sedation for diagnostic procedures, and intraoperative wake-up test for surgery of the spine. Results: The use of monitoring with the bispectral index has shown benefits reducing time to extubation, orientation in time and place, and discharge from both the operating room and post anesthetic care unit. The risk of nausea and vomiting after surgery was reduced by 12% in patients monitored with bispectral index. Occurred a reduction of 3% in the risk of cognitive impairment postoperatively at 3 months postoperatively and 6% reduction in the risk of postoperative delirium in patients monitored with bispectral index. Furthermore, the risk of intraoperative memory has been reduced by 1%. Conclusion: Clinically, anesthesia monitoring with the BIS can be justified because it allows advantages from reducing the recovery time after waking, mainly by reducing the administration of general anesthetics as well as the risk of adverse events.

A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring

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Santos Cristina

2010-10-01

Full Text Available Abstract Background Intrapartum fetal hypoxia remains an important cause of death and permanent handicap and in a significant proportion of cases there is evidence of suboptimal care related to fetal surveillance. Cardiotocographic (CTG monitoring remains the basis of intrapartum surveillance, but its interpretation by healthcare professionals lacks reproducibility and the technology has not been shown to improve clinically important outcomes. The addition of fetal electrocardiogram analysis has increased the potential to avoid adverse outcomes, but CTG interpretation remains its main weakness. A program for computerised analysis of intrapartum fetal signals, incorporating real-time alerts for healthcare professionals, has recently been developed. There is a need to determine whether this technology can result in better perinatal outcomes. Methods/design This is a multicentre randomised clinical trial. Inclusion criteria are: women aged ≥ 16 years, able to provide written informed consent, singleton pregnancies ≥ 36 weeks, cephalic presentation, no known major fetal malformations, in labour but excluding active second stage, planned for continuous CTG monitoring, and no known contra-indication for vaginal delivery. Eligible women will be randomised using a computer-generated randomisation sequence to one of the two arms: continuous computer analysis of fetal monitoring signals with real-time alerts (intervention arm or continuous CTG monitoring as previously performed (control arm. Electrocardiographic monitoring and fetal scalp blood sampling will be available in both arms. The primary outcome measure is the incidence of fetal metabolic acidosis (umbilical artery pH ecf > 12 mmol/L. Secondary outcome measures are: caesarean section and instrumental vaginal delivery rates, use of fetal blood sampling, 5-minute Apgar score Discussion This study will provide evidence of the impact of intrapartum monitoring with computer analysis and real

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

OpenAIRE

Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

2016-01-01

Our interest lies in quality control for clinical trials, in the context of risk-based monitoring (RBM). We specifically study the use of central statistical monitoring (CSM) to support RBM. Under an RBM paradigm, we claim that CSM has a key role to play in identifying the "risks to the most critical data elements and processes" that will drive targeted oversight. In order to support this claim, we first see how to characterize the risks that may affect clinical trials. We then discuss how CS...

Clinical and biochemical monitoring of patients with fatty acid oxidation disorders

DEFF Research Database (Denmark)

Lund, Allan Meldgaard; Skovby, Flemming; Vestergaard, Helle

2010-01-01

complicated assessments by a neuropsychologist, speech therapist, or physical and occupational therapists. Paraclinical measurements are not used for short-chain and medium-chain disorders; electrocardiography (including 24 h monitoring) and echocardiography are done for most patients with long......Evidence-based guidelines for monitoring patients with disorders in fatty acid oxidation (FAO) are lacking, and most protocols are based on expert statements. Here, we describe our protocol for Danish patients. Clinical monitoring is the most important measure and has the main aims of checking...... carnitine is measured to monitor carnitine supplementation in patients with multiple acyl-coenzyme A dehydrogenase deficiency (MADD) and carnitine transporter deficiency (CTD) and to follow metabolic control and disclose deficiency states in other FAO disorders. We are evaluating long-chain acylcarnitines...

ELISPOT Assay for Monitoring Cytotoxic T Lymphocytes (CTL Activity in Cancer Vaccine Clinical Trials

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Thomas J. Sayers

2012-05-01

Full Text Available The profiling and monitoring of immune responses are key elements in the evaluation of the efficacy and development of new biotherapies, and a number of assays have been introduced for analyzing various immune parameters before, during, and after immunotherapy. The choice of immune assays for a given clinical trial depends on the known or suggested immunomodulating mechanisms associated with the tested therapeutic modality. Cell-mediated cytotoxicity represents a key mechanism in the immune response to various pathogens and tumors. Therefore, the selection of monitoring methods for the appropriate assessment of cell-mediated cytotoxicity is thought to be crucial. Assays that can detect both cytotoxic T lymphocytes (CTL frequency and function, such as the IFN-γ enzyme-linked immunospot assay (ELISPOT have gained increasing popularity for monitoring clinical trials and in basic research. Results from various clinical trials, including peptide and whole tumor cell vaccination and cytokine treatment, have shown the suitability of the IFN-γ ELISPOT assay for monitoring T cell responses. However, the Granzyme B ELISPOT assay and Perforin ELISPOT assay may represent a more direct analysis of cell-mediated cytotoxicity as compared to the IFN-γ ELISPOT, since Granzyme B and perforin are the key mediators of target cell death via the granule-mediated pathway. In this review we analyze our own data and the data reported by others with regard to the application of various modifications of ELISPOT assays for monitoring CTL activity in clinical vaccine trials.

Ambulatory blood pressure monitoring in clinical trials with antihypertensive agents

NARCIS (Netherlands)

A.H. van den Meiracker (Anton)

1995-01-01

textabstractAmbulatory blood pressure monitoring (ABPM) is being used increasingly for the evaluation of antihypertensive agents in clinical trials. In this brief review several aspects of ABPM are discussed. In particular, attention is paid to the extent to which ABPM is subject to a placebo

A wearable smartphone-based platform for real-time cardiovascular disease detection via electrocardiogram processing.

Science.gov (United States)

Oresko, Joseph J; Duschl, Heather; Cheng, Allen C

2010-05-01

Cardiovascular disease (CVD) is the single leading cause of global mortality and is projected to remain so. Cardiac arrhythmia is a very common type of CVD and may indicate an increased risk of stroke or sudden cardiac death. The ECG is the most widely adopted clinical tool to diagnose and assess the risk of arrhythmia. ECGs measure and display the electrical activity of the heart from the body surface. During patients' hospital visits, however, arrhythmias may not be detected on standard resting ECG machines, since the condition may not be present at that moment in time. While Holter-based portable monitoring solutions offer 24-48 h ECG recording, they lack the capability of providing any real-time feedback for the thousands of heart beats they record, which must be tediously analyzed offline. In this paper, we seek to unite the portability of Holter monitors and the real-time processing capability of state-of-the-art resting ECG machines to provide an assistive diagnosis solution using smartphones. Specifically, we developed two smartphone-based wearable CVD-detection platforms capable of performing real-time ECG acquisition and display, feature extraction, and beat classification. Furthermore, the same statistical summaries available on resting ECG machines are provided.

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

Science.gov (United States)

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 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.

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

Science.gov (United States)

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

2018-06-01

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

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

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Parmenion P. Tsitsopoulos

2017-11-01

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

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

Science.gov (United States)

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

2017-11-01

Non-invasive hemodynamic monitoring has the potential to be a valuable clinical tool for the screening and management of hypertensive disorders of pregnancy. The objective of this study was to validate the clinical utility of the non-invasive cardiac output monitoring (NICOM) system in pregnant women. Twenty healthy pregnant women with a singleton pregnancy at 22 to 26 weeks' gestation were enrolled in this study. Measures of heart rate, stroke volume, and cardiac output were obtained through NICOM and compared with Doppler echocardiography. NICOM significantly overestimated measures of both stroke volume and cardiac output compared with Doppler echocardiography (95 ± 4 vs. 73 ± 4 mL, P gold standard for the measurement of cardiac output in the setting of pregnancy. However, once normal values have been established, NICOM has the potential to be a useful clinical tool for monitoring maternal hemodynamics in pregnant women. Further investigation regarding the validity of NICOM is required in larger populations of healthy and hypertensive pregnant women to determine whether this device is appropriate for maternal hemodynamic assessment during pregnancy. Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

Accuracy of flash glucose monitoring and continuous glucose monitoring technologies: Implications for clinical practice.

Science.gov (United States)

Ajjan, Ramzi A; Cummings, Michael H; Jennings, Peter; Leelarathna, Lalantha; Rayman, Gerry; Wilmot, Emma G

2018-02-01

Continuous glucose monitoring and flash glucose monitoring technologies measure glucose in the interstitial fluid and are increasingly used in diabetes care. Their accuracy, key to effective glycaemic management, is usually measured using the mean absolute relative difference of the interstitial fluid sensor compared to reference blood glucose readings. However, mean absolute relative difference is not standardised and has limitations. This review aims to provide a consensus opinion on assessing accuracy of interstitial fluid glucose sensing technologies. Mean absolute relative difference is influenced by glucose distribution and rate of change; hence, we express caution on the reliability of comparing mean absolute relative difference data from different study systems and conditions. We also review the pitfalls associated with mean absolute relative difference at different glucose levels and explore additional ways of assessing accuracy of interstitial fluid devices. Importantly, much data indicate that current practice of assessing accuracy of different systems based on individualised mean absolute relative difference results has limitations, which have potential clinical implications. Healthcare professionals must understand the factors that influence mean absolute relative difference as a metric for accuracy and look at additional assessments, such as consensus error grid analysis, when evaluating continuous glucose monitoring and flash glucose monitoring systems in diabetes care. This in turn will ensure that management decisions based on interstitial fluid sensor data are both effective and safe.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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

2015-01-01

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

Conventional heart rate variability analysis of ambulatory electrocardiographic recordings fails to predict imminent ventricular fibrillation

Science.gov (United States)

Vybiral, T.; Glaeser, D. H.; Goldberger, A. L.; Rigney, D. R.; Hess, K. R.; Mietus, J.; Skinner, J. E.; Francis, M.; Pratt, C. M.

1993-01-01

OBJECTIVES. The purpose of this report was to study heart rate variability in Holter recordings of patients who experienced ventricular fibrillation during the recording. BACKGROUND. Decreased heart rate variability is recognized as a long-term predictor of overall and arrhythmic death after myocardial infarction. It was therefore postulated that heart rate variability would be lowest when measured immediately before ventricular fibrillation. METHODS. Conventional indexes of heart rate variability were calculated from Holter recordings of 24 patients with structural heart disease who had ventricular fibrillation during monitoring. The control group consisted of 19 patients with coronary artery disease, of comparable age and left ventricular ejection fraction, who had nonsustained ventricular tachycardia but no ventricular fibrillation. RESULTS. Heart rate variability did not differ between the two groups, and no consistent trends in heart rate variability were observed before ventricular fibrillation occurred. CONCLUSIONS. Although conventional heart rate variability is an independent long-term predictor of adverse outcome after myocardial infarction, its clinical utility as a short-term predictor of life-threatening arrhythmias remains to be elucidated.

Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA

Directory of Open Access Journals (Sweden)

Christie E Tung

2015-01-01

Full Text Available Background: It is important to evaluate patients with TIA or stroke for atrial fibrillation (AF because the detection of AF changes the recommended anti-thrombotic regimen from treatment with an antiplatelet agent to oral anticoagulation. This study describes the diagnostic yield of a patch-based, single-use, and water-resistant 14-day continuous cardiac rhythm monitor (ZIO Patch in patients with stroke or TIA.Methods: We obtained data from the manufacturer and servicer of the ZIO Patch (iRhythm Technologies. Patients who were monitored between January 2012 and June 2013 and whose indication for monitoring was TIA or stroke were included. The duration of monitoring, the number and type of arrhythmias, and the time to first arrhythmia were documented. Results: 1,171 monitoring reports were analyzed. The mean monitor wear time was 10.9 days and the median wear time was 13.0 days (interquartile range 7.2-14.0. The median analyzable time relative to the total wear time was 98.7% (IQR 96.0-99.5%. AF was present in 5.0% of all reports. The mean duration before the first episode of paroxysmal AF (PAF was 1.5 days and the median duration was 0.4 days. 14.3% of first PAF episodes occurred after 48 hours. The mean PAF burden was 12.7% of the total monitoring duration. Conclusion: Excellent quality of the recordings and very good patient compliance coupled with a substantial proportion of AF detection beyond the first 48 hours of monitoring suggest that the cardiac patch is superior to conventional 48-hour Holter monitors for AF detection in patients with stroke or TIA.

Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA.

Science.gov (United States)

Tung, Christie E; Su, Derek; Turakhia, Mintu P; Lansberg, Maarten G

2014-01-01

It is important to evaluate patients with transient ischemic attack (TIA) or stroke for atrial fibrillation (AF) because the detection of AF changes the recommended anti-thrombotic regimen from treatment with an antiplatelet agent to oral anticoagulation. This study describes the diagnostic yield of a patch-based, single-use, and water-resistant 14-day continuous cardiac rhythm monitor (ZIO Patch) in patients with stroke or TIA. We obtained data from the manufacturer and servicer of the ZIO Patch (iRhythm Technologies). Patients who were monitored between January 2012 and June 2013 and whose indication for monitoring was TIA or stroke were included. The duration of monitoring, the number and type of arrhythmias, and the time to first arrhythmia were documented. One thousand one hundred seventy-one monitoring reports were analyzed. The mean monitor wear time was 10.9 days and the median wear time was 13.0 days (interquartile range 7.2-14.0). The median analyzable time relative to the total wear time was 98.7% (IQR 96.0-99.5%). AF was present in 5.0% of all reports. The mean duration before the first episode of paroxysmal AF (PAF) was 1.5 days and the median duration was 0.4 days. 14.3% of first PAF episodes occurred after 48 h. The mean PAF burden was 12.7% of the total monitoring duration. Excellent quality of the recordings and very good patient compliance coupled with a substantial proportion of AF detection beyond the first 48 h of monitoring suggest that the cardiac patch is superior to conventional 48-h Holter monitors for AF detection in patients with stroke or TIA.

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

Science.gov (United States)

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

Clinical Use of Continuous Glucose Monitoring in Adults with Type 1 Diabetes.

Science.gov (United States)

Slattery, David; Choudhary, Pratik

2017-05-01

With the emphasis on intensive management of type 1 diabetes, data from studies support frequent monitoring of glucose levels to improve glycemic control and reduce glucose variability, which can be related to an increase in macro and microvascular complications. However, few perform capillary blood glucose that frequently. There are currently two available alternatives that this review will discuss, continuous glucose monitoring (CGM) and flash glucose monitoring. CGM has become an important diagnostic and therapeutic option in optimizing diabetes management. CGM systems are now more accurate, smaller, and easier to use compared to original models. Randomized controlled trials (RCTs) have demonstrated that CGM can improve Hemoglobin A1c (HbA1C) and reduce glucose variability in both continuous subcutaneous insulin infusion and multiple daily injection users. When used in an automated "insulin-suspend" system, reduced frequency of hypoglycemia and shorter time spent in hypoglycemic range have been demonstrated. Despite the potential benefits CGM has to offer in clinical practice, concerns exist on the accuracy of these devices and patient compliance with therapy, which may prevent the true clinical benefit of CGM being achieved, as observed in RCTs. Flash glucose monitoring systems FreeStyle ® Libre™ (Abbott Diabetes Care, Alameda, CA) are as accurate as many CGM systems available and have the added benefit of being factory calibrated. Studies have shown that flash glucose monitoring systems are very well tolerated by patients and effectively reduce glucose variability, increasing time in range.

Assesment of Rhythm Disorders in Classical and Nonclassical Mitral Valve Prolapse.

Science.gov (United States)

Hodzic, Enisa

2018-02-01

Mitral Valve Prolapse (MVP) is the most common cardiac valve pathology of to day. Aim of article was to identify the types and frequency of potentially malignant arrhythmia and atrial brillation in patients with MVP, to determine the differences in these arrhythmias between classical and non-classical MVP, to evaluate the correlation of potentially malignant arrhythmia and atrial fibrillation with MVP with possible clinical complications of arrhythmogenic sudden cardiac death and potential risk of thromboembolic vascular incident. Article has retrospective-prospective analytical character and present observational study on 239 patients (120 with MVP (66 with classical and 54 with non-classical MVP), who had a subjective feeling of palpitations and/or pain in the chest, and/or episode of syncope, and did not have ischemic heart disease or another valve pathology) and 119 healthy patients in the control group. All patients were analyzed by 24-hour ECG Holter. Signifficant difference in all analyzed arrhythmias between classical MVP and control group (p MVP (p = 0.016). The potential risk of cardiac death and vascular incidence is signi cantly higher in classical MVP than in non-classical MVP, implying the need for routine ECG-Holter monitoring in their diagnosis for timely prevention of clinical arrhythmogenic complications.

Impaired chronotropic response to physical activities in heart failure patients.

Science.gov (United States)

Shen, Hong; Zhao, Jianrong; Zhou, Xiaohong; Li, Jingbo; Wan, Qing; Huang, Jing; Li, Hui; Wu, Liqun; Yang, Shungang; Wang, Ping

2017-05-25

While exercise-based cardiac rehabilitation has a beneficial effect on heart failure hospitalization and mortality, it is limited by the presence of chronotropic incompetence (CI) in some patients. This study explored the feasibility of using wearable devices to assess impaired chronotropic response in heart failure patients. Forty patients with heart failure (left ventricular ejection fraction, LVEF: 44.6 ± 5.8; age: 54.4 ± 11.7) received ECG Holter and accelerometer to monitor heart rate (HR) and physical activities during symptom-limited treadmill exercise testing, 6-min hall walk (6MHW), and 24-h daily living. CI was defined as maximal HR during peak exercise testing failing to reach 70% of age-predicted maximal HR (APMHR, 220 - age). The correlation between HR and physical activities in Holter-accelerometer recording was analyzed. Of 40 enrolled patients, 26 were able to perform treadmill exercise testing. Based on exercise test reports, 13 (50%) of 26 patients did not achieve at least 70% of APMHR (CI patients). CI patients achieved a lower % APMHR (62.0 ± 6.3%) than non-CI patients who achieved 72.0 ± 1.2% of APMHR (P failure patients who took treadmill exercise testing. The wearable Holter-accelerometer recording could help to identify impaired chronotropic response to physical activities in heart failure patients. ClinicalTrials.gov ID NCT02358603 . Registered 16 May 2014.

Use of self-monitoring tools in a clinic sample of adults with type 2 diabetes.

Science.gov (United States)

Tanenbaum, Molly L; Bhatt, Harikrashna B; Thomas, Valerie A; Wing, Rena R

2017-06-01

Self-monitoring is an effective strategy for chronic disease management; many readily available mobile applications allow tracking of diabetes-related health behaviors but their use has not yet been integrated into routine clinical care. How patients engage with these applications in the real world is not well understood. The specific aim of this study is to survey adults with type 2 diabetes (T2D) regarding self-monitoring behaviors, including mobile application use. In 2015, we surveyed an adult diabetes clinic population (n = 96) regarding self-monitoring behaviors: diet, physical activity, weight, and blood glucose. Self-monitoring with any method ranged from 20-90 %. About half of the participants owned smartphones; few had mobile applications. The most common app-tracked behavior was physical activity, then weight and diet. Despite numerous available mobile health-tracking applications, few T2D adults from our sample used them, though many reported self-monitoring with other methods.

Monitoring worksite clinic performance using a cost-benefit tool.

Science.gov (United States)

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.

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

Science.gov (United States)

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

2018-05-01

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

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

Science.gov (United States)

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

2017-03-01

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

Change-Point Detection Method for Clinical Decision Support System Rule Monitoring.

Science.gov (United States)

Liu, Siqi; Wright, Adam; Hauskrecht, Milos

2017-06-01

A clinical decision support system (CDSS) and its components can malfunction due to various reasons. Monitoring the system and detecting its malfunctions can help one to avoid any potential mistakes and associated costs. In this paper, we investigate the problem of detecting changes in the CDSS operation, in particular its monitoring and alerting subsystem, by monitoring its rule firing counts. The detection should be performed online, that is whenever a new datum arrives, we want to have a score indicating how likely there is a change in the system. We develop a new method based on Seasonal-Trend decomposition and likelihood ratio statistics to detect the changes. Experiments on real and simulated data show that our method has a lower delay in detection compared with existing change-point detection methods.

Integrated monitoring: Setting new standards for the next decade of clinical trial practice

Directory of Open Access Journals (Sweden)

Kamala Rai

2011-01-01

Full Text Available The new age clinical research professional is now geared toward an "integrated monitoring" approach. A number of critical activities at the site level and at the sponsor′s organization need convergence to harness rich dividends in early study start and quick close of the study. The field monitor needs full integration to ensure standard of care, train the site in protocol, select the right site, ensure regulatory support, ensure excellent project management skills, coach, support the logistics team, manage the vendor, ensure good documentation practices, develop patient recruitment and retention, lean the applicable process, as well as ensure effective site management amongst the myriad activities assigned toward developing the drug in the clinic.

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

Science.gov (United States)

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

2018-04-17

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

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

Science.gov (United States)

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

2015-12-30

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

Monitoring antimalarial safety and tolerability in clinical trials: A case study from Uganda

Directory of Open Access Journals (Sweden)

Mpimbaza Arthur

2008-06-01

Full Text Available Abstract Background New antimalarial regimens, including artemisinin-based combination therapies (ACTs, have been adopted widely as first-line treatment for uncomplicated malaria. Although these drugs appear to be safe and well-tolerated, experience with their use in Africa is limited and continued assessment of safety is a priority. However, no standardized guidelines for evaluating drug safety and tolerability in malaria studies exist. A system for monitoring adverse events in antimalarial trials conducted in Uganda was developed. Here the reporting system is described, and difficulties faced in analysing and interpreting the safety results are illustrated, using data from the trials. Case description Between 2002 and 2007, eleven randomized, controlled clinical trials were conducted to compare the efficacy, safety, and tolerability of different antimalarial regimens for treatment of uncomplicated malaria in Uganda. The approach to adverse event monitoring was similar in all studies. A total of 5,614 treatments were evaluated in 4,876 patients. Differences in baseline characteristics and patterns of adverse event reporting were noted between the sites, which limited the ability to pool and analyse data. Clinical failure following antimalarial treatment confounded associations between treatment and adverse events that were also common symptoms of malaria, particularly in areas of lower transmission intensity. Discussion and evaluation Despite prospectively evaluating for adverse events, limitations in the monitoring system were identified. New standardized guidelines for monitoring safety and tolerability in antimalarial trials are needed, which should address how to detect events of greatest importance, including serious events, those with a causal relationship to the treatment, those which impact on adherence, and events not previously reported. Conclusion Although the World Health Organization has supported the development of

Resource reduction in pediatric chest pain: Standardized clinical assessment and management plan.

Science.gov (United States)

Saleeb, Susan F; McLaughlin, Sarah R; Graham, Dionne A; Friedman, Kevin G; Fulton, David R

2018-01-01

Using a Standardized Clinical Assessment and Management Plan (SCAMP) for pediatric patients presenting to clinic with chest pain, we evaluated the cost impact associated with implementation of the care algorithm. Prior to introduction of the SCAMP, we analyzed charges for 406 patients with chest pain, seen in 2009, and predicted 21% reduction of overall charges had the SCAMP methodology been used. The SCAMP recommended an echocardiogram for history, examination, or ECG findings suggestive of a cardiac etiology for chest pain. Resource utilization was reviewed for 1517 patients (7-21 years) enrolled in the SCAMP from July 2010 to April 2014. Compared to the 2009 historic cohort, patients evaluated by the SCAMP had higher rates of exertional chest pain (45% vs 37%) and positive family history (5% vs 1%). The SCAMP cohort had fewer abnormal physical examination findings (1% vs 6%) and abnormal electrocardiograms (3% vs 5%). Echocardiogram use increased in the SCAMP cohort compared to the 2009 historic cohort (45% vs 41%), whereas all other ancillary testing was reduced: exercise stress testing (4% SCAMP vs 28% historic), Holter (4% vs 7%), event monitors (3% vs 10%), and MRI (1% vs 2%). Total charges were reduced by 22% ($822 625) by use of the Chest Pain SCAMP, despite a higher percentage of patients for whom echocardiogram was recommended compared to the historic cohort. The Chest Pain SCAMP effectively streamlines cardiac testing and reduces resource utilization. Further reductions can be made by algorithm refinement regarding echocardiograms for exertional symptoms. © 2017 Wiley Periodicals, Inc.

Clinical outcomes of the inclusion of the therapeutic drug monitoring report in the electronic clinical record

Directory of Open Access Journals (Sweden)

Marina Sáez Belló

2016-12-01

Full Text Available Objectives: To assess the inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record (ECR. Method: An observational ambispective cohort study with a duration of 149 days: PRE (retrospective, 49 days with the TDMR printed in paper, and POST (prospective, 100 days with the TDMR included in the ECR. Exclusion criteria: Patients not hospitalized, applications for Therapeutic Drug Monitoring by Critical Care and Neonatal Units, as well as monitoring with an objective other than dose adjustment. Variables: Number of TDMRs prepared, number of patients admitted with TDMR, time of delay for treatment adjustment, defined as the number of adjustments made to the treatment within over or under 24 hours from the time of TDMR preparation, and medication errors (MEs associated with said delay, as well as the degree of acceptance of the TDMR. Results: 690 TDMRs were conducted in 391 patients, 339 in PRE (n = 206 and 351 in POST (n = 185. The number of treatment modifications made in under 24 hours increased from 73.9% in PRE to 87.3% in POST [RR = 1.2 (CI95% = 0.97-1.43. We identified 35 patients with ME, 9.7% of them in PRE and 8.1% in POST (RR = 0.84 (CI95% = 0.44-1.58]. The degree of acceptance of the pharmacist recommendation increased from 53.3% in PRE to 68.3% in POST [RR = 1.3 (CI95% = 1.02- 1.62]. Conclusions: The inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record increases the degree of acceptance of recommendations, and may reduce the delay in treatment modifications, reducing MEs and improving the process quality in terms of efficacy and safety

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

Science.gov (United States)

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

2017-06-01

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

Prosthetic Valve Endocarditis - Successful Management With Antimicrobial Treatment

Directory of Open Access Journals (Sweden)

Ashokan Nambiar C

2015-07-01

Full Text Available Middle aged male was admitted with high fever, rigor and chills of 2 days duration. He was seen in the clinic two years back for syncope. He gave history of Mitral (Starr-Edward and Aortic (Medtronic valve replacement ten years earlier from another center and was on regular anticoagulation with dose-adjusted acenocoumarol. On evaluation he had normal prosthetic valve function by trans-thoracic echo, but Holter monitoring showed Paroxysmal Atrial Fibrillation. He had mild wall motion abnormalities and left ventricular dysfunction suggestive of coronary artery disease also and was put on additional Metoprolol.

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

Science.gov (United States)

Garg, Uttam; Zhang, Yan Victoria

2016-01-01

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

Intermittent versus Persistent Wolff-Parkinson-White Syndrome in Children: Electrophysiologic Properties and Clinical Outcomes.

Science.gov (United States)

Kiger, Michelle E; McCanta, Anthony C; Tong, Suhong; Schaffer, Michael; Runciman, Martin; Collins, Kathryn K

2016-01-01

Intermittent Wolff-Parkinson-White (WPW) syndrome is considered to have a lower risk of sudden death. Fewer data exist regarding electrophysiologic (EP) characteristics and the natural history of intermittent WPW in children. All patients with WPW age 1-18 years at a single institution (1996-2013) were reviewed. Patients with intermittent preexcitation were compared to those with loss of preexcitation on Holter/exercise testing and those with persistent preexcitation. High-risk accessory pathway (AP) was defined as AP effective refractory period (APERP), block cycle length, or shortest preexcited RR interval during atrial fibrillation ≤250 ms. A total of 295 patients were included: 226 (76.6%) persistent, 39 (13.2%) intermittent, and 30 (10.2%) loss of preexcitation Holter/exercise. There were no differences in symptoms between groups. Median interquartile range APERP was significantly longer in intermittent WPW (380 [320, 488] ms vs 320 [300, 350] ms persistent, 310 [290, 330] ms loss of preexcitation Holter/exercise; P = 0.0008). At baseline, there was no difference between groups in frequency of high-risk pathways. However, when isoproterenol values were included, high-risk pathways were more frequent among patients with loss of preexcitation on Holter/exercise (54% vs 16% persistent, 11% intermittent; P = 0.005). There was one death in a patient with loss of preexcitation on exercise testing, no EP study, and prior drug use. A second patient with persistent WPW and APERP 270 ms required resuscitation following a methadone overdose. Intermittent preexcitation in children does not connote a lower risk AP by EP criteria or reduced symptoms. The low number of pediatric WPW patients who develop preexcited atrial fibrillation or sudden death warrants larger studies to investigate these outcomes. ©2015 Wiley Periodicals, Inc.

A comparison of internal versus external risk-adjustment for monitoring clinical outcomes

NARCIS (Netherlands)

Koetsier, Antonie; de Keizer, Nicolette; Peek, Niels

2011-01-01

Internal and external prognostic models can be used to calculate severity of illness adjusted mortality risks. However, it is unclear what the consequences are of using an external model instead of an internal model when monitoring an institution's clinical performance. Theoretically, using an

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

Science.gov (United States)

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.

Can individualized weight monitoring using the HeartPhone algorithm improve sensitivity for clinical deterioration of heart failure?

LENUS (Irish Health Repository)

Ledwidge, Mark T

2013-04-01

Previous studies have demonstrated poor sensitivity of guideline weight monitoring in predicting clinical deterioration of heart failure (HF). This study aimed to evaluate patterns of remotely transmitted daily weights in a high-risk HF population and also to compare guideline weight monitoring and an individualized weight monitoring algorithm.

Short-term biological variation of clinical chemical values in dumeril's monitors (Varanus dumerili)

DEFF Research Database (Denmark)

Bertelsen, Mads Frost; Kjelgaard-Hansen, Mads Jens; Howell, Jennifer R.

2007-01-01

Plasma biochemical values are routinely used in the medical management of ill reptiles, and for monitoring the health of clinically normal animals. Laboratory tests, including clinical biochemical values, are subject to biological and analytical variation, the magnitude of which determines the ut...

Noninvasive Strategy Based on Real-Time in Vivo Cataluminescence Monitoring for Clinical Breath Analysis.

Science.gov (United States)

Zhang, Runkun; Huang, Wanting; Li, Gongke; Hu, Yufei

2017-03-21

The development of noninvasive methods for real-time in vivo analysis is of great significant, which provides powerful tools for medical research and clinical diagnosis. In the present work, we described a new strategy based on cataluminescence (CTL) for real-time in vivo clinical breath analysis. To illustrate such strategy, a homemade real-time CTL monitoring system characterized by coupling an online sampling device with a CTL sensor for sevoflurane (SVF) was designed, and a real-time in vivo method for the monitoring of SVF in exhaled breath was proposed. The accuracy of the method was evaluated by analyzing the real exhaled breath samples, and the results were compared with those obtained by GC/MS. The measured data obtained by the two methods were in good agreement. Subsequently, the method was applied to real-time monitoring of SVF in exhaled breath from rat models of the control group to investigate elimination pharmacokinetics. In order to further probe the potential of the method for clinical application, the elimination pharmacokinetics of SVF from rat models of control group, liver fibrosis group alcohol liver group, and nonalcoholic fatty liver group were monitored by the method. The raw data of pharmacokinetics of different groups were normalized and subsequently subjected to linear discriminant analysis (LDA). These data were transformed to canonical scores which were visualized as well-clustered with the classification accuracy of 100%, and the overall accuracy of leave-one-out cross-validation procedure is 88%, thereby indicating the utility of the potential of the method for liver disease diagnosis. Our strategy undoubtedly opens up a new door for real-time clinical analysis in a pain-free and noninvasive way and also guides a promising development direction for CTL.

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

Science.gov (United States)

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.

Intraesophageal impedance monitoring: clinical studies

NARCIS (Netherlands)

Conchillo Armendáriz, J.M.

2007-01-01

Electrical impedance (Z) between two electrodes is the ratio between applied voltage (U) and resulting current (I). In electrical impedance monitoring the resistance to electrical flow in an alternating current circuit is measured. Multichannel esophageal monitoring can be measured by using an

Clinical results from a noninvasive blood glucose monitor

Science.gov (United States)

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

2002-05-01

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

Monitoring cancer stem cells: insights into clinical oncology

Directory of Open Access Journals (Sweden)

Lin SC

2016-02-01

Full Text Available ShuChen Lin,1,* YingChun Xu,2,* ZhiHua Gan,1 Kun Han,1 HaiYan Hu,3 Yang Yao,3 MingZhu Huang,4 DaLiu Min1 1Department of Oncology, Shanghai Sixth People’s Hospital East Campus, Shanghai Jiao Tong University, 2Department of Oncology, Renji Hospital, Shanghai Jiao Tong University, 3Department of Oncology, The Sixth People’s Hospital, Shanghai Jiao Tong University, 4Department of Medical Oncology, Cancer Hospital of Fudan University, Shanghai, People’s Republic of China *These authors contributed equally to this work Abstract: Cancer stem cells (CSCs are a small, characteristically distinctive subset of tumor cells responsible for tumor initiation and progression. Several treatment modalities, such as surgery, glycolytic inhibition, driving CSC proliferation, immunotherapy, and hypofractionated radiotherapy, may have the potential to eradicate CSCs. We propose that monitoring CSCs is important in clinical oncology as CSC populations may reflect true treatment response and assist with managing treatment strategies, such as defining optimal chemotherapy cycles, permitting pretreatment cancer surveillance, conducting a comprehensive treatment plan, modifying radiation treatment, and deploying rechallenge chemotherapy. Then, we describe methods for monitoring CSCs. Keywords: cancer stem cells, glycolytic inhibition, watchful waiting, rechallenge, immunotherapy

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

DEFF Research Database (Denmark)

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

2014-01-01

is being piloted in a clinical trial for prostate cancer patients treated with VMAT (NCT01742403). The purpose of this work was to develop clinical process and quality assurance (QA) practices for the clinical implementation of KIM. Methods: Informed by and adapting existing guideline documents from other...... real-time monitoring systems, KIM-specific QA practices were developed. The following five KIM-specific QA tests were included: (1) static localization accuracy, (2) dynamic localization accuracy, (3) treatment interruption accuracy, (4) latency measurement, and (5) clinical conditions accuracy. Tests...... developed and implemented for prostate cancer VMAT....

CONTINUOUS HOLTER MONITORING OF PATIENTS WITH CARDIOVASCULAR DISEASES IN ORAL SURGERY

OpenAIRE

Hristo Daskalov; Lyudmila Vladimirova-Kitova; F. Nikolov; E. Sarachev

2011-01-01

Introduction. Pain control and anxiety management are important aspects of modern dental treatment. Although many local anesthetics and anesthesia techniques have so far been studied, there is still no clarity as to what anesthetic should be used in cardiovascularly compromised patients. This anesthetic and its dosage should be very carefully chosen to achieve optimal effective pain control; the possible side effects occurring mainly in morbidly compromised patients should also be well studie...

CONTINUOUS HOLTER MONITORING OF PATIENTS WITH CARDIOVASCULAR DISEASES IN ORAL SURGERY

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Hristo Daskalov

2011-09-01

Full Text Available Introduction. Pain control and anxiety management are important aspects of modern dental treatment. Although many local anesthetics and anesthesia techniques have so far been studied, there is still no clarity as to what anesthetic should be used in cardiovascularly compromised patients. This anesthetic and its dosage should be very carefully chosen to achieve optimal effective pain control; the possible side effects occurring mainly in morbidly compromised patients should also be well studied.Methods. The aim of this study was to study the effect of vasoconstrictors on local anesthetics in 18 patients with heart diseases. The study contingent was recruited from the patients visiting often their general dental practitioners and diagnosed with the following heart diseases: Heart failure (after 6 months; ischemic heart disease, including mild angina pectoris. Articaine was used as local anesthetic. Results. The ST segment on the ECG was used to detect myocardial ischemia and to study the effect of the administered local anesthesia.Conclusion. The study results suggest that pain control in a cardiovascularly compromised patient subjected to oral surgery should be carried out only after thorough analysis is conducted of the specific condition and current status of the patient. Additional hematological tests shoud be done to enable the dentist to build a viable treatment plan.

Cardiac asystole following cannabis (marijuana) usage--additional mechanism for sudden death?

Science.gov (United States)

Menahem, Samuel

2013-12-10

A 21 year old university student previously operated during infancy for an unobstructed total anomalous pulmonary venous drainage with an excellent result, was noted on a routine follow up 24 h Holter monitor to have multiple pauses related to cardiac asystole, the longest lasting 5.8 s and temporally related to marijuana inhalation. A repeat Holter was normal following a two week cessation of marijuana usage and again when carried out 3 months later. The documented periods of asystole may be a precursor of sudden death seen in addicts even without evidence of ischaemic heart disease. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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

Science.gov (United States)

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

2016-01-01

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

The Effect of Valsartan on Heart Rate Variability and Heart Rate Recovery in Patients with Mild to Moderate Mitral Stenosis

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Ali Metin Esen

2010-04-01

Full Text Available Summary: Atrial fibrillation (AF is known to be one of the most important complications of mitral stenosis (MS. It has been reported that autonomic nervous system (ANS had an effect on AF development, heart rate variability (HRV and heart rate recovery (HRR were under the control of ANS, and their disorders were present in MS. We studied the effect of Valsartan on HRV and HRT, and thus its effect on ANS. Methods: Eleven patients (39±8 years, 10 females with mild to moderate MS were included in the study. Sixteen volunteers (38±8 years, 14 females matched for age and sex were selected for control group. All subjects underwent transthoracic echocardiography (TTE, symptom-limited treadmill test and 24 hour Holter monitorization.The patients were administered 160 mg of Valsartan daily for 14 weeks. TTE, treadmill test and Holter monitorization were repeated at the end of treatment period. In Holter monitorization, the time and frequency domain analysis of HRV and in exercise test, HRR at first and third minutes (HRR1 and HRR3 were examined. Results: Before Valsartan treatment, no significant difference was found in HRR and HRV parameters between the two groups. Systolic and diastolic blood pressure, and also HRR1values were significantly decreased after treatment of Valsartan (117±6 vs. 107±4 mmHg p<0.002, 76±6 vs. 69±9 mmHg p<0.044, 44±14 vs. 33±12 p< 0.014, respectively, while the exercise time was significantly increased (786±114 vs. 846±95 sn p< 0.044. In Holter analysis neither time nor frequency domain of HRV parameters showed a meaningful change. Conclusion: In moderate MS, treatment with Valsartan improved the effort capacity, while autonomic function parameters have been defined on the base of HRV and HRR were not significantly different.

Ventricular arrhythmia burst is an independent indicator of larger infarct size even in optimal reperfusion in STEMI

NARCIS (Netherlands)

van der Weg, Kirian; Majidi, Mohamed; Haeck, Joost D. E.; Tijssen, Jan G. P.; Green, Cynthia L.; Koch, Karel T.; Kuijt, Wichert J.; Krucoff, Mitchell W.; Gorgels, Anton P. M.; de Winter, Robbert J.

2016-01-01

We hypothesized that ventricular arrhythmia (VA) bursts during reperfusion phase are a marker of larger infarct size despite optimal epicardial and microvascular perfusion. 126 STEMI patients were studied with 24h continuous, 12-lead Holter monitoring. Myocardial blush grade (MBG) was determined and

Use of left ventricular ejection fraction or wall-motion score index in predicting arrhythmic death in patients following an acute myocardial infarction. The TRACE Study Group

DEFF Research Database (Denmark)

Køber, L; Torp-Pedersen, C; Elming, H

1997-01-01

on the correlation between arrhythmic death and "sudden unexpected death" defined as death within 1 hour of onset of new symptoms. Assessment of late potentials, heart rate variability (HRV), T wave alternans, arrhythmias seen on Holter monitoring or during exercise testing, electrophysiological testing...

Independent academic Data Monitoring Committees for clinical trials in cardiovascular and cardiometabolic diseases

NARCIS (Netherlands)

Filippatos, Gerasimos S.; de Graeff, Pieter; Bax, Jeroen J.; Borg, John-Joseph; Cleland, John G. F.; Dargie, Henry J.; Flather, Marcus; Ford, Ian; Friede, Tim; Greenberg, Barry; Henon-Goburdhun, Cecile; Holcomb, Richard; Horst, Bradley; Lekakis, John; Mueller-Velten, Guenther; Papavassiliou, Athanasios G.; Prasad, Krishna; Rosano, Giuseppe M. C.; Severin, Thomas; Sherman, Warren; Stough, Wendy Gattis; Swedberg, Karl; Tavazzi, Luigi; Tousoulis, Dimitris; Vardas, Panagiotis; Ruschitzka, Frank; Anker, Stefan D.

Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study participants and to maintain a trial's scientific integrity. Generally accepted standards exist for DMC composition and operational conduct. However, some relevant issues are not

Echocardiographic and clinical findings in patients with Fabry disease during long-term enzyme replacement therapy

DEFF Research Database (Denmark)

Madsen, Christoffer Valdorff; Bundgaard, Henning; Rasmussen, Åse Krogh

2017-01-01

from baseline to follow-up; 30 mm [15-53] vs. 25 mm [3-44], p vs. 1520 mm·ms [550-5740], p within the non-ERT group. During follow-up, cardiac symptoms and use of cardiovascular procedures and -medication increased...... significantly in the ERT group, whereas no differences were observed within the non-ERT group. DISCUSSION: We raise concerns regarding the efficacy and benefit of ERT on cardiac involvement in Fabry disease and stress the need for further research....... and Holter-monitoring. RESULTS: We included 66 patients; 47 patients (27 women) received ERT (ERT group) and 19 patients (15 women) did not (non-ERT group). The groups were followed for a median of 8 [0-12] years and 6 [0-13] years, respectively. Comparison between ERT and non-ERT receiving patients by left...

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

Science.gov (United States)

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.

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

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Sourabh De

2011-01-01

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

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

Science.gov (United States)

De, Sourabh

2011-07-01

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

Clinical evaluation of a new intracranial pressure monitoring device.

Science.gov (United States)

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

2003-03-01

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

Immune Monitoring in Cancer Vaccine Clinical Trials: Critical Issues of Functional Flow Cytometry-Based Assays

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Iole Macchia

2013-01-01

Full Text Available The development of immune monitoring assays is essential to determine the immune responses against tumor-specific antigens (TSAs and tumor-associated antigens (TAAs and their possible correlation with clinical outcome in cancer patients receiving immunotherapies. Despite the wide range of techniques used, to date these assays have not shown consistent results among clinical trials and failed to define surrogate markers of clinical efficacy to antitumor vaccines. Multiparameter flow cytometry- (FCM- based assays combining different phenotypic and functional markers have been developed in the past decade for informative and longitudinal analysis of polyfunctional T-cells. These technologies were designed to address the complexity and functional heterogeneity of cancer biology and cellular immunity and to define biomarkers predicting clinical response to anticancer treatment. So far, there is still a lack of standardization of some of these immunological tests. The aim of this review is to overview the latest technologies for immune monitoring and to highlight critical steps involved in some of the FCM-based cellular immune assays. In particular, our laboratory is focused on melanoma vaccine research and thus our main goal was the validation of a functional multiparameter test (FMT combining different functional and lineage markers to be applied in clinical trials involving patients with melanoma.

Melatonin reduces cardiac morbidity and markers of myocardial ischemia after elective abdominal aortic aneurism repair

DEFF Research Database (Denmark)

Gögenür, Ismail; Kücükakin, Bülent; Panduro Jensen, Leif

2014-01-01

The aim was to examine the effect of perioperative melatonin treatment on clinical cardiac morbidity and markers of myocardial ischemia in patients undergoing elective surgery for abdominal aortic aneurism. Reperfusion injury results in increased cardiac morbidity in patients undergoing surgery...... for abdominal aortic aneurisms (AAA). A randomized, placebo-controlled, clinical trial including patients undergoing surgery for AAA was performed. The patients received by infusion over a 2-hr period either, 50 mg melatonin or placebo intra-operatively, and 10 mg melatonin or placebo orally, the first three...... by Holter monitoring. A total of 26 patients received melatonin, while 24 received placebo. A significant reduction in cardiac morbidity was seen in the melatonin-treated patients compared with those given placebo [4% versus 29% (P = 0.02)]. Five patients (19%) who received melatonin had increased Tp...

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

Science.gov (United States)

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

2015-08-01

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

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

Science.gov (United States)

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

2018-05-15

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

Complete paroxysmal atrioventricular block in a 2-year-old girl

DEFF Research Database (Denmark)

Holst, Line Marie; Dixen, Ulrik; Jeppesen, Dorthe L

2015-01-01

We present a case of atypical syncope in a 2-year-old, otherwise healthy girl. The patient presented with three episodes of syncope without any precipitating factors and no family history of sudden unexpected death. Holter monitoring revealed 24 events of complete atrioventricular block lasting up...

Cost effectiveness analysis of clinically driven versus routine laboratory monitoring of antiretroviral therapy in Uganda and Zimbabwe.

Directory of Open Access Journals (Sweden)

Antonieta Medina Lara

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

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

Science.gov (United States)

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

2017-01-01

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

24-HOUR ELECTROCARDIOGRAPHY IN CLINICAL HEALTHY CAVALIER KING CHARLES SPANIELS, WIRE-HAIRED DACHSHUNDS AND CAIRN TERRIERS

DEFF Research Database (Denmark)

Rasmussen, Caroline Elisabeth; Vesterholm, Stina; Ludvigsen, Trine Pagh

2010-01-01

analysis were analyzed for influence by breed, age, gender, relevant heart rate (HR) parameters and bodyweight. CKCS had a significantly higher HRex (mean 121 ± SD 12 bpm) compared to wD (94±18 bpm) (P>0.0001) and CT (102±16bpm) (P=0.0009). The minimum HR (HRmin) measured during Holter recording...... was significantly higher in CKCS (51±10 bpm) compared to wD (42±7 bpm) (P=0.001) and CT (45±7 bpm) (P=0.05). In addition, CKCS had a higher mean HR (HRmean) during Holter recording (83±13 bpm) compared to wD (68±8 bpm) (P>0.0001) and CT (75±10 bpm) (P=0.04). Both HRmean (P>0.0001) and HRmin (P=0.001) were...

The Healthy Aging Brain Care (HABC Monitor: validation of the Patient Self-Report Version of the clinical tool designed to measure and monitor cognitive, functional, and psychological health

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Monahan PO

2014-12-01

Full Text Available Patrick O Monahan,1 Catherine A Alder,2–4 Babar A Khan,1–3 Timothy Stump,1 Malaz A Boustani1–4 1Indiana University School of Medicine, Indianapolis, IN, USA; 2Indiana University Center for Aging Research, Indianapolis, IN, USA; 3Regenstrief Institute Inc., Indianapolis, IN, USA; 4Eskenazi Health, Indianapolis, IN, USA Background: Primary care providers need an inexpensive, simple, user-friendly, easily standardized, sensitive to change, and widely available multidomain instrument to measure the cognitive, functional, and psychological symptoms of patients suffering from multiple chronic conditions. We previously validated the Caregiver Report Version of the Healthy Aging Brain Care Monitor (HABC Monitor for measuring and monitoring the severity of symptoms through caregiver reports. The purpose of this study was to assess the reliability and validity of the Patient Self-Report Version of the HABC Monitor (Self-Report HABC Monitor.Design: Cross-sectional study.Setting: Primary care clinics affiliated with a safety net urban health care system in Indianapolis, Indiana, USA.Subjects: A total of 291 subjects aged ≥65 years with a mean age of 72.7 (standard deviation 6.2 years, 76% female, and 56% African Americans.Analysis: Psychometric validity and reliability of the Self-Report HABC Monitor.Results: Among 291 patients analyzed, the Self-Report HABC Monitor demonstrated excellent fit for the confirmatory factor analysis model (root mean square error of approximation =0.030, comparative fit index =0.974, weighted root mean square residual =0.837 and good internal consistency (0.78–0.92. Adequate convergent–divergent validity (differences between the Telephone Interview for Cognitive Status test-based cognitive function impairment versus nonimpairment groups was demonstrated only when patients were removed from analysis if they had both cognitive function test impairment and suspiciously perfect self-report HABC Monitor cognitive floor

Clinical implication of blood glucose monitoring in general dental offices: the Ehime Dental Diabetes Study

OpenAIRE

Harase, Tadahiro; Nishida, Wataru; Hamakawa, Tomohiro; Hino, Satoshi; Shigematsu, Kenji; Kobayashi, Satoru; Sako, Hirofumi; Ito, Shirou; Murakami, Hajime; Nishida, Kei; Inoue, Hiroshi; Fujisawa, Masahito; Yoshizu, Hiroshi; Kawamura, Ryoichi; Takata, Yasunori

2015-01-01

Objective We examined whether general dentists can contribute to the detection of patients with undiagnosed diabetes and prediabetes by monitoring blood glucose in dental clinics. Research design and methods A total of 716 patients who visited clinics for dental treatment were enrolled and classified into 3 groups (mild, moderate, and severe) according to Kornman's criteria for periodontitis. The correlations between the casual blood glucose level, presence or absence of the history of diabet...

Atrial Fibrillation in Hypertrophic Cardiomyopathy: Prevalence, Clinical Correlations, and Mortality in a Large High‐Risk Population

Science.gov (United States)

Siontis, Konstantinos C.; Geske, Jeffrey B.; Ong, Kevin; Nishimura, Rick A.; Ommen, Steve R.; Gersh, Bernard J.

2014-01-01

Background Atrial fibrillation (AF) is a common sequela of hypertrophic cardiomyopathy (HCM), but evidence on its prevalence, risk factors, and effect on mortality is sparse. We sought to evaluate the prevalence of AF, identify clinical and echocardiographic correlates, and assess its effect on mortality in a large high‐risk HCM population. Methods and Results We identified HCM patients who underwent evaluation at our institution from 1975 to 2012. AF was defined by known history (either chronic or paroxysmal), electrocardiogram, or Holter monitoring at index visit. We examined clinical and echocardiographic variables in association with AF. The effect of AF on overall and cause‐specific mortality was evaluated with multivariate Cox proportional hazards models. Of 3673 patients with HCM, 650 (18%) had AF. Patients with AF were older and more symptomatic (P<0.001). AF was less common among patients with obstructive HCM phenotype and was associated with larger left atria, higher E/e’ ratios, and worse cardiopulmonary exercise tolerance (all P values<0.001). During median (interquartile range) follow‐up of 4.1 (0.2 to 10) years, 1069 (29%) patients died. Patients with AF had worse survival compared to those without AF (P<0.001). In multivariate analysis adjusted for established risk factors of mortality in HCM, the hazard ratio (95% confidence interval) for the effect of AF on overall mortality was 1.48 (1.27 to 1.71). AF did not have an effect on sudden or nonsudden cardiac death. Conclusions In this large referral HCM population, approximately 1 in 5 patients had AF. AF was a strong predictor of mortality, even after adjustment for established risk factors. PMID:24965028

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

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Pfeiffer Yvonne

2010-12-01

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

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

Science.gov (United States)

Briner, Matthias; Kessler, Oliver; Pfeiffer, Yvonne; Wehner, Theo; Manser, Tanja

2010-12-13

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

α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (MACS) study.

Science.gov (United States)

Shimabukuro, Michio; Tanaka, Atsushi; Sata, Masataka; Dai, Kazuoki; Shibata, Yoshisato; Inoue, Yohei; Ikenaga, Hiroki; Kishimoto, Shinji; Ogasawara, Kozue; Takashima, Akira; Niki, Toshiyuki; Arasaki, Osamu; Oshiro, Koichi; Mori, Yutaka; Ishihara, Masaharu; Node, Koichi

2017-07-06

Little is known about clinical associations between glucose fluctuations including hypoglycemia, heart rate variability (HRV), and the activity of the sympathetic nervous system (SNS) in patients with acute phase of acute coronary syndrome (ACS). This pilot study aimed to evaluate the short-term effects of glucose fluctuations on HRV and SNS activity in type 2 diabetes mellitus (T2DM) patients with recent ACS. We also examined the effect of suppressing glucose fluctuations with miglitol on these variables. This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group comparative study included 39 T2DM patients with recent ACS, who were randomly assigned to either a miglitol group (n = 19) or a control group (n = 20). After initial 24-h Holter electrocardiogram (ECG) (Day 1), miglitol was commenced and another 24-h Holter ECG (Day 2) was recorded. In addition, continuous glucose monitoring (CGM) was performed throughout the Holter ECG. Although frequent episodes of subclinical hypoglycemia (≤4.44 mmo/L) during CGM were observed on Day 1 in the both groups (35% of patients in the control group and 31% in the miglitol group), glucose fluctuations were decreased and the minimum glucose level was increased with substantial reduction in the episodes of subclinical hypoglycemia to 7.7% in the miglitol group on Day 2. Holter ECG showed that the mean and maximum heart rate and mean LF/HF were increased on Day 2 in the control group, and these increases were attenuated by miglitol. When divided 24-h time periods into day-time (0700-1800 h), night-time (1800-0000 h), and bed-time (0000-0700 h), we found increased SNS activity during day-time, increased maximum heart rate during night-time, and glucose fluctuations during bed-time, which were attenuated by miglitol treatment. In T2DM patients with recent ACS, glucose fluctuations with subclinical hypoglycemia were associated with alterations of HRV and SNS activity, which were mitigated by

Use of electrical impedance tomography to monitor regional cerebral edema during clinical dehydration treatment.

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Feng Fu

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

Avaliação clínica e funcional tardia de arritmias em crianças operadas de Tetralogia de Fallot Evaluación clínica y funcional tardía de arritmias en niños operados de tetralogía de Fallot Late clinical and functional assessment of arrhythmias in children after repair of Tetralogy of Fallot

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Maria Eulália Thebit Pfeiffer

2010-09-01

undergoing repair of TF, and to associate them with clinical aspects and laboratory tests. METHODS: Cross-sectional study of 37 patients undergoing repair of TF at Instituto Estadual de Cardiologia Aloysio de Castro (Rio de Janeiro. After review of the medical records and clinical assessment, the patients underwent electrocardiography (ECG, echocardiography (Echo, 24-h Holter monitoring and exercise test (ET, whose results were subjected to statistical analysis. RESULTS: A total of 37 patients of whom 54% were males with a mean age of 9.7 ± 3.5 years and mean follow-up period of 4.7 ± 1.9 years were studied. The abnormalities most frequently found were: on ECG: right bundle branch block (89%; Echo: severe pulmonary regurgitation (43%, mild pulmonary stenosis (73%, moderate right ventricular hypertrophy (RVH, 57%; on ET: low exercise capacity (90%, impaired chronotropic response (40%, arrhythmias (20%; on Holter monitoring: arrhythmias (59%, of which 44% were ventricular, 38% supraventricular, and 24% both ventricular and supraventricular, with predominance of infrequent and benign ventricular premature beats. Five patients (15% presented with multiform ventricular premature beats. There was an association of ventricular arrhythmia with moderate and severe RVH (p=0.026, as well as with right ventricle-to-pulmonary artery gradient (RV/PA > 45 mmHg (p=0.004. The logistic regression analysis showed that increased RV/PA gradient was an independent predictor of ventricular arrhythmia (p=0.017. CONCLUSION: Cardiac arrhythmia was a common finding in a large proportion of children and adolescents after surgical repair of TF; however, it was infrequent and benign in most of the cases. The RV/PA gradient was considered a strong predictor of ventricular arrhythmia.

Calibration of area monitors for neutrons used in clinical linear accelerators; Calibracao de monitores de area para neutrons usados em aceleradores lineares clinicos

Energy Technology Data Exchange (ETDEWEB)

Salgado, Ana Paula; Pereira, Walsan Wagner; Patrao, Karla C. de Souza; Fonseca, Evaldo S. da, E-mail: asalgado@ird.gov.b [Instituto de Radioprotecao e Dosimetria (IRD/CNEN-RJ), Rio de Janeiro, RJ (Brazil); Batista, Delano V.S. [Instituto Nacional do Cancer (INCa), Rio de Janeiro, RJ (Brazil)

2009-07-01

This work demonstrates the complexity and the necessary cares for the realization of measurements of neutron fields in rooms for radiotherapy treatment containing clinical accelerators. The acquaintance of the technical characteristics of the monitors and the periodic calibration are actions and fundamental procedures to guarantee traceability and the reliability of measurements

Sibling teenage pregnancy and clinic-referred girls’ condom use: The protective role of maternal monitoring

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Nichols, Sara; Javdani, Shabnam; Rodriguez, Erin; Emerson, Erin; Donenberg, Geri

2016-01-01

Younger sisters of teenage parents have elevated rates of engaging in unprotected sex. This may result from changes in parenting behavior after a sibling becomes pregnant or impregnates a partner, and be particularly pronounced for girls seeking mental health treatment. The current study examines condom use over time in 211 African-American girls recruited from outpatient psychiatric clinics. Findings indicate that having a sibling with a teenage pregnancy history predicts less consistent condom use two years later. After accounting for earlier condom use and mental health problems, maternal monitoring moderates condom use such that for girls with a sibling with a pregnancy history, more vigilant maternal monitoring is associated with increased condom use, while for girls with no sibling pregnancy history, maternal monitoring is unrelated to adolescents’ condom use two years later. Findings suggest that targeted interventions to increase maternal monitoring of high-risk teens may be beneficial for girls with a sibling history of teenage pregnancy. PMID:27172111

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

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Setia S

2017-07-01

only 55% said that they had the ability to provide education on HBPM and BPV. Patient inertia, poor patient compliance, lack of medical consultation time, and poor patient access to a BP machine were the most common challenges for implementing out-of-office BP monitoring. Conclusion: Although physicians from Singapore do recommend out-of-office BP measurement to patients with hypertension, this survey identified several important gaps in knowledge and clinical practice. Keywords: hypertension, blood pressure monitoring, blood pressure variability, guidelines

A low-power and miniaturized electrocardiograph data collection system with smart textile electrodes for monitoring of cardiac function.

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Dai, Ming; Xiao, Xueliang; Chen, Xin; Lin, Haoming; Wu, Wanqing; Chen, Siping

2016-12-01

With the increasing aging population as well as health concerns, chronic heart disease has become the focus of public attention. A comfortable, low-powered, and wearable electrocardiogram (ECG) system for continuously monitoring the elderly's ECG signals over several hours is important for preventing cardiovascular diseases. Traditional ECG monitoring apparatus is often inconvenient to carry, has many electrodes to attach to the chest, and has a high-power consumption. There is also a challenge to design an electrocardiograph that satisfies requirements such as comfort, confinement, and compactness. Based on these considerations, this study presents a biosensor acquisition system for wearable, ubiquitous healthcare applications using three textile electrodes and a recording circuit specialized for ECG monitoring. In addition, several methods were adopted to reduce the power consumption of the device. The proposed system is composed of three parts: (1) an ECG analog front end (AFE), (2) digital signal processing and micro-control circuits, and (3) system software. Digital filter methods were used to eliminate the baseline wander, skin contact noise, and other interfering signals. A comparative study was conducted using this system to observe its performance with two commercial Holter monitors. The experimental results demonstrated that the total power consumption of this proposed system in a full round of ECG acquisition was only 29.74 mW. In addition, this low-power system performed well and stably measured the heart rate with an accuracy of 98.55 %. It can also contain a real-time dynamic display with organic light-emitting diodes (OLED) and wirelessly transmit information via a Bluetooth 4.0 module.

Clinical predictors and impact of ambulatory blood pressure monitoring in pediatric hypertension referrals.

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Davis, Marguerite L; Ferguson, Michael A; Zachariah, Justin P

2014-09-01

Elevated blood pressure (BP) is rising in children. Significant proportions of children have reactive hypertension or masked hypertension, making ambulatory BP monitoring (ABPM) a valuable tool, although with potential economic implications. In youth referred for elevated BP, we sought clinic BP combinations that obviated the need for ABPM and to specify the economic role of ABPM. In a retrospective pediatric referral cohort (N = 170), we examine clinic systolic BP (SBP) predictors of components of ABPM hypertension and their combination. In economic analyses, we compared effectiveness and charges of three diagnostic pathways: (1) clinic BP alone; (2) abnormal clinic BP prompting ABPM; or (3) universal ABPM. ABPM hypertension occurred in 55 (32.4%) and reactive hypertension in 37 (21.8%), average automated (β = 0.208; 95% confidence interval, 0.027, 0.389; P = .03) and maximum auscultatory clinic SBP (β = 0.160; 95% confidence interval 0.022, 0.299; P = .02) were associated with ABPM SBP mean, but none predicted SBP load. No clinic SBP combination was associated with ABPM hypertension. Universal ABPM accrued the lowest average charge per hypertensive youth identified ($10,948). We did not identify a clinic SBP combination that predicted ABPM hypertension in youth referred for elevated BP. Universal ABPM, in this context, may be the most economically and clinically efficient diagnostic strategy. Copyright © 2014 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

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

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

2016-01-01

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

Evaluation of the environmental equivalent dose rate using area monitors for neutrons in clinical linear accelerators

International Nuclear Information System (INIS)

Salgado, Ana Paula; Pereira, Walsan Wagner; Patrao, Karla C. de Souza; Fonseca, Evaldo S. da; Batista, Delano V.S.

2009-01-01

The Neutron Laboratory of the Radioprotection and Dosimetry Institute - IRD/CNEN, Rio de Janeiro, Brazil, initiated studies on the process of calibration of neutron area monitors and the results of the measurements performed at radiotherapy treatment rooms, containing clinical accelerators

Atrial fibrillation is not uncommon among patients with ischemic stroke and transient ischemic stroke in China.

Science.gov (United States)

Yang, Xiaomeng; Li, Shuya; Zhao, Xingquan; Liu, Liping; Jiang, Yong; Li, Zixiao; Wang, Yilong; Wang, Yongjun

2017-12-04

Atrial fibrillation (AF) is reported to be a less frequent cause of ischemic stroke in China than in Europe and North America, but it is not clear whether this is due to underestimation. Our aim was to define the true frequency of AF-associated stroke, to determine the yield of 6-day Holter ECG to detect AF in Chinese stroke patients, and to elucidate predictors of newly detected AF. Patients with acute ischemic stroke or transient ischemic attack (TIA) were enrolled in a prospective, multicenter cohort study of 6-day Holter monitoring within 7 days after stroke onset at 20 sites in China between 2013 and 2015. Independent predictors of newly-detected AF were determined by multivariate analysis. Among 1511 patients with ischemic stroke and TIA (mean age 63 years, 33.1% women), 305 (20.2%) had either previously known (196, 13.0%) or AF newly-detected by electrocardiography (53, 3.5%) or by 6-day Holter monitoring (56/1262, 4.4%). A history of heart failure (OR = 4.70, 95%CI, 1.64-13.5), advanced age (OR = 1.06, 95%CI, 1.04-1.09), NIHSS at admission (OR = 1.06, 95%CI, 1.02-1.10), blood high density lipoprotein (HDL) (OR = 1.52, 95%CI, 1.09-2.13), together with blood triglycerides (OR = 0.64, 95%CI, 0.45-0.91) were independently associated with newly-detected AF. Contrary to previous reports, AF-associated stroke is frequent (20%) in China if systemically sought. Prolonged noninvasive cardiac rhythm monitoring importantly increases AF detection in patients with recent ischemic stroke and TIA in China. Advanced age, history of heart failure, and higher admission NIHSS and higher level of HDL were independent indicators of newly-detected AF. NCT02156765 (June 5, 2014).

Ambulatory blood pressure monitoring in daily clinical practice - the Spanish ABPM Registry experience.

Science.gov (United States)

Gorostidi, Manuel; Banegas, José R; de la Sierra, Alejandro; Vinyoles, Ernest; Segura, Julián; Ruilope, Luis M

2016-01-01

Many patients are hypertensive at the medical settings but show normal blood pressure out of the doctor's office, and are classified as white-coat hypertensives. On the other hand, many patients with controlled hypertension at the clinic show ambulatory blood pressure levels above the thresholds considered for an adequate blood pressure control, known as having masked hypertension. Using data from the Spanish Ambulatory Blood Pressure Monitoring Registry (Spanish ABPM Registry), a national program developed to promote the use of the ambulatory technique for hypertension management in daily practice, we have reviewed the main strengths of this approach, that is the ability to detect discrepancies of blood pressure status with respect to office blood pressure measurement, and to better assess accurate rates of hypertension control. White-coat hypertension within patients with elevated office blood pressure, and masked hypertension within office-controlled patients affected one of three patients in each office status. On the other hand, rates of ambulatory blood pressure control (50%) doubled those of office blood pressure control (25%), still remaining half the patients uncontrolled. We think that a systematic use of ambulatory blood pressure monitoring, and strategies to improve blood pressure control constitute key priorities in hypertension management. © 2015 Stichting European Society for Clinical Investigation Journal Foundation.

Current investigation and management of patients with syncope

DEFF Research Database (Denmark)

Dagres, Nikolaos; Bongiorni, Maria Grazia; Dobreanu, Dan

2013-01-01

and indications for tilt table testing in neurally mediated syncope. The majority of centres reported using ECG, echocardiography, and Holter monitoring as their main diagnostic tools in patients with syncope, whereas a smaller proportion of centres applied specific assessment algorithms. Physical manoeuvres were...... almost uniformely reported as the standard treatment for neurally mediated syncope....

Heart rate turbulence after ventricular premature beats in healthy Doberman pinschers and those with dilated cardiomyopathy.

Science.gov (United States)

Harris, J D; Little, C J L; Dennis, J M; Patteson, M W

2017-10-01

To describe the measurement of heart rate turbulence (HRT) after ventricular premature beats and compare HRT in healthy Doberman pinschers and those with dilated cardiomyopathy (DCM), with and without congestive heart failure (CHF). Sixty-five client-owned Dobermans: 20 healthy (NORMAL), 31 with preclinical DCM and 14 with DCM and CHF (DCM + CHF). A retrospective study of data retrieved from clinical records and ambulatory ECG (Holter) archives, including data collected previously for a large-scale prospective study of Dobermans with preclinical DCM. Holter data were reanalysed quantitatively, including conventional time-domain heart rate variability and the HRT parameters turbulence onset and turbulence slope. Heart rate turbulence could be measured in 58/65 dogs. Six Holter recordings had inadequate ventricular premature contractions (VPCs) and one exhibited VPCs too similar to sinus morphology. Heart rate turbulence parameter, turbulence onset, was significantly reduced in DCM dogs, whereas conventional heart rate variability measures were not. Heart rate variability and HRT markers were reduced in DCM + CHF dogs as expected. Heart rate turbulence can be measured from the majority of good quality standard canine 24-hour Holter recordings with >5 VPCs. Turbulence onset is significantly reduced in Dobermans with preclinical DCM which indicates vagal withdrawal early in the course of disease. Heart rate turbulence is a powerful prognostic indicator in human cardiac disease which can be measured from standard 24-hour ambulatory ECG (Holter) recordings using appropriate computer software. Further studies are warranted to assess whether HRT may be of prognostic value in dogs with preclinical DCM and in other canine cardiac disease. Copyright © 2017 Elsevier B.V. All rights reserved.

The impact of clinical trial monitoring approaches on data integrity and cost--a review of current literature.

Science.gov (United States)

Olsen, Rasmus; Bihlet, Asger Reinstrup; Kalakou, Faidra; Andersen, Jeppe Ragnar

2016-04-01

Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety data, data integrity, and monitoring cost. The literature search was performed by keyword searches in MEDLINE and hand search of key journals. All publications were reviewed for details on how a monitoring approach impacted subject safety data, data integrity, or monitoring costs. Twenty-two publications were identified. Three publications showed that SDV has some value for detection of not initially reported adverse events and centralized statistical monitoring (CSM) captures atypical trends. Fourteen publications showed little objective evidence of improved data integrity with traditional monitoring such as 100 % SDV and sponsor queries as compared to reduced SDV, CSM, and remote monitoring. Eight publications proposed a potential for significant cost reductions of monitoring by reducing SDV without compromising the validity of the trial results. One hundred percent SDV is not a rational method of ensuring data integrity and subject safety based on the high cost, and this literature review indicates that reduced SDV is a viable monitoring method. Alternative methods of monitoring such as centralized monitoring utilizing statistical tests are promising alternatives but have limitations as stand-alone tools. Reduced SDV combined with a centralized, risk-based approach may be the ideal solution to reduce monitoring costs while improving essential data quality.

Low Incidence of Atrial Fibrillation in Patients with Transient Ischemic Attack

DEFF Research Database (Denmark)

Pedersen, Kenneth Bruun; Chemnitz, Alexander; Madsen, Charlotte

2016-01-01

on admission ECG. Another 2 (1.2%) were diagnosed with AF on Holter monitoring. In total, 6 patients (3.5%) were diagnosed with AF. Patients with AF were significantly older (mean age 79.4 [95% CI 65.1-93.6] years) than patients without AF (mean age 67.6 [95% CI 65.6-69.5] years) but otherwise showed...

Journal of Clinical Monitoring and Computing 2015 end of year summary : tissue oxygenation and microcirculation

NARCIS (Netherlands)

Scheeren, T W L

Last year we started this series of end of year summaries of papers published in the 2014 issues of the Journal Of Clinical Monitoring And Computing with a review on near infrared spectroscopy (Scheeren et al. in J Clin Monit Comput 29(2):217-220, 2015). This year we will broaden the scope and

Electrocardiogram Pattern Recognition and Analysis Based on Artificial Neural Networks and Support Vector Machines: A Review

Directory of Open Access Journals (Sweden)

Mario Sansone

2013-01-01

Full Text Available Computer systems for Electrocardiogram (ECG analysis support the clinician in tedious tasks (e.g., Holter ECG monitored in Intensive Care Units or in prompt detection of dangerous events (e.g., ventricular fibrillation. Together with clinical applications (arrhythmia detection and heart rate variability analysis, ECG is currently being investigated in biometrics (human identification, an emerging area receiving increasing attention. Methodologies for clinical applications can have both differences and similarities with respect to biometrics. This paper reviews methods of ECG processing from a pattern recognition perspective. In particular, we focus on features commonly used for heartbeat classification. Considering the vast literature in the field and the limited space of this review, we dedicated a detailed discussion only to a few classifiers (Artificial Neural Networks and Support Vector Machines because of their popularity; however, other techniques such as Hidden Markov Models and Kalman Filtering will be also mentioned.

Mass Spectrometry for Research and Application in Therapeutic Drug Monitoring or Clinical and Forensic Toxicology.

Science.gov (United States)

Maurer, Hans H

2018-04-30

This paper reviews current applications of various hyphenated low- and high-resolution mass spectrometry techniques in the field of therapeutic drug monitoring and clinical/forensic toxicology in both research and practice. They cover gas chromatography, liquid chromatography, matrix-assisted laser desorption ionization, or paper spray ionization coupled to quadrupole, ion trap, time-of-flight, or Orbitrap mass analyzers.

Early and late arrhythmogenic effects of doxorubicin.

Science.gov (United States)

Kilickap, Saadettin; Barista, Ibrahim; Akgul, Ebru; Aytemir, Kudret; Aksoy, Sercan; Tekuzman, Gulten

2007-03-01

To determine the incidence of early and late arrhythmogenic effects of doxorubicin-containing chemotherapy regimens. A prospective study including 29 patients who were treated with doxorubicin-containing regimens. Cardiac evaluation was based on 24-hour electrocardiographic monitorization (Holter), which was performed during the first cycle of doxorubicin-containing regimens, as well as after the last cycle of chemotherapy. The mean age of the patients was 45.8 +/- 15.1 (range 18-69). Holter records obtained during the first cycle of treatment revealed varying arrhythmias in 19 patients (65.5%) and in 18 (62.1%) patients after completion of therapy. One patient presented with syncope and both Mobitz Type 2 atrioventricular block and complete atrioventricular block were demonstrated. The patient subsequently underwent permanent pacemaker implantation. Doxorubicin may result in arrhythmias both in early and late periods of treatment. These arrhythmias are rarely life threatening.

Clinical validation study of the SignCare Vital Signs Monitor of Fundación Cardiovascular de Colombia

Directory of Open Access Journals (Sweden)

Leonardo Andrés Rodríguez-Salazar

2016-07-01

Conclusions: The SignCare device is as reliable as the commercial monitor in the qualitative detection of morphologic alterations of electrocardiogram records, as well as in breathing, temperature, oxygen saturation and blood pressure parameters, which makes it recommendable for clinical use in adult population.

Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support.

Science.gov (United States)

Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria

2018-01-01

This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collated data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data.

Evaluation of commercial self-monitoring devices for clinical purposes

DEFF Research Database (Denmark)

Leth, Søren; Hansen, John; Nielsen, Olav Wendelboe

2017-01-01

Commercial self-monitoring devices are becoming increasingly popular, and over the last decade, the use of self-monitoring technology has spread widely in both consumer and medical markets. The purpose of this study was to evaluate five commercially available self-monitoring devices for further...

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

Science.gov (United States)

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

2003-02-19

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

Reliability of clinical monitoring for the diagnosis of babesiosis in dogs in Nigeria

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Adebayo OO

2016-07-01

Full Text Available Olufunke Omowunmi Adebayo,1 Rasheed Adetola Ajadi,2 Temidayo Olutayo Omobowale,3 Samuel Olatunbosun Omotainse,4 Morenike Atinuke Dipeolu,5 Helen Oyebukola Nottidge,3 Ebenezer Babatunde Otesile2 1Veterinary Teaching Hospital, 2Department of Veterinary Medicine and Surgery, College of Veterinary Medicine, Federal University of Agriculture, Abeokuta, 3Faculty of Veterinary Medicine, University of Ibadan, Ibadan, 4Department of Veterinary Pathology, 5Department of Veterinary Public Health and Reproduction, College of Veterinary Medicine, Federal University of Agriculture, Abeokuta, Nigeria Abstract: Babesiosis accounts for a high percentage of hospital cases in canines in Africa, with about 40% mortality in the cases presented. In Nigeria, records show an estimated 30% annual morbidity when diagnosis is largely based on clinical and laboratory findings. This study monitored clinical indices associated with canine babesiosis. One hundred and three babesiosis-suspected dogs were selected on the basis of clinical signs of anorexia, fever, presence of ticks, and enlarged lymph nodes or spleen when clinical parameters were recorded at the time of presentation. Parasite detection was done using thin blood smears; that is, the presence of Babesia merozoites was compared between capillary and cephalic blood. Blood was also assayed for hematology and blood chemistry using automated blood analyzers. The babesiosis-infected dogs’ outcome was monitored. Data obtained were analyzed using chi-square test, analysis of variance, and Pearson’s correlation. Results based on thin blood smears showed that 61.1% of the dogs were positive for Babesia species. Breed disposition, sex, and age did not significantly influence the incidence of Babesia canis, while mean rectal temperatures did not differ significantly between the cases (P>0.05. Heart rate and pulse rates of Babesia-positive dogs were significantly (P<0.05 higher than those that were negative. The packed

Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials

OpenAIRE

Desmet, Lieven; Venet, David; Doffagne, Erik; Timmermans, Catherine; Legrand, Catherine; Burzykowski, Tomasz; Buyse, Marc

2017-01-01

As part of central statistical monitoring of multicenter clinical trial data, we propose a procedure based on the beta-binomial distribution for the detection of centers with atypical values for the probability of some event. The procedure makes no assumptions about the typical event proportion and uses the event counts from all centers to derive a reference model. The procedure is shown through simulations to have high sensitivity and high specificity if the contamination rate is small and t...

Severe abnormal Heart Rate Turbulence Onset is associated with deterioration of liver cirrhosis

DEFF Research Database (Denmark)

Jansen, Christian; Al-Kassou, Baravan; Lehmann, Jennifer

2018-01-01

BACKGROUND: In patients with liver cirrhosis, cardiac dysfunction is frequent and is associated with increased morbidity and mortality. Cardiac dysfunction in cirrhosis seems to be linked to autonomic dysfunction. This study investigates the role of autonomic dysfunction assessed by Heart Rate...... Turbulence (HRT) analyses in patients with liver cirrhosis. METHODS AND PATIENTS: Inclusion criteria was (1) diagnosis of cirrhosis by clinical, imaging or biopsy and (2) evaluation by standard 12-lead-ECG and 24h holter monitoring and (3) at least 3 premature ventricular contractions. The exclusion...... criterion was presence of cardiac diseases, independent of liver cirrhosis. Biochemical parameters were analysed using standard methods. HRT was assessed using Turbulence onset (TO) and slope (TS). The endpoint was deterioration of liver cirrhosis defined as increased MELD and readmission for complications...

Predicted Interval Plots (PIPS): A Graphical Tool for Data Monitoring of Clinical Trials.

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Li, Lingling; Evans, Scott R; Uno, Hajime; Wei, L J

2009-11-01

Group sequential designs are often used in clinical trials to evaluate efficacy and/or futility. Many methods have been developed for different types of endpoints and scenarios. However, few of these methods convey information regarding effect sizes (e.g., treatment differences) and none uses prediction to convey information regarding potential effect size estimates and associated precision, with trial continuation. To address these limitations, Evans et al. (2007) proposed to use prediction and predicted intervals as a flexible and practical tool for quantitative monitoring of clinical trials. In this article, we reaffirm the importance and usefulness of this innovative approach and introduce a graphical summary, predicted interval plots (PIPS), to display the information obtained in the prediction process in a straightforward yet comprehensive manner. We outline the construction of PIPS and apply this method in two examples. The results and the interpretations of the PIPS are discussed.

The clinical value of enzyme-multiplied immunoassay technique monitoring the plasma concentrations of cyclosporine A after renal transplantation

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Xiao-Hui Luo

2011-05-01

Full Text Available The feasibility and the clinical value of the enzyme-multiplied immunoassay technique (EMIT monitoring of blood concentrations of cyclosporine A (CsA in patients treated with CsA were investigated after kidney transplantation. The validation method was performed to the EMIT determination of CsA blood concentration, the CsA whole blood ‘trough concentrations (C0 of patients in different time periods after renal transplantation were monitored, and combined with the clinical complications, the statistical results were analyzed and compared. EMIT was precise, accurate and stable, also with a high quality control. The mean postoperative blood concentration of CsA was as follows: 12 months, (185.6 ± 28.1ng/mL. The toxic reaction rate of CsA blood concentration within the recommended therapeutic concentration was 14. 1%, significantly lower than that of the none-recommended dose group (37.2% (P < 0.05; the transplantation rejection rate was 4.4%, significantly lower than that of the none-recommended dose group (22.5% (P < 0.05. Using EMIT to monitor the blood concentration of CsA as the routine laboratory method is feasible, and is able to reduce the CsA toxicity and rejection significantly, leading to achieving the desired therapeutic effect. Keywords: enzyme-multiplied immunoassay technique, renal transplantation, cyclosporin A, blood concentration monitoring

Therapeutic Drug Monitoring of Venlafaxine in an Everyday Clinical Setting

DEFF Research Database (Denmark)

Hansen, Morten Rix; Kuhlmann, Ida Berglund; Pottegård, Anton

2017-01-01

Venlafaxine is a commonly used antidepressant agent. We aimed to provide detailed information on the associations between venlafaxine dose and concentrations of venlafaxine, by patient age and sex. From a therapeutic drug monitoring (TDM) database located at Odense University Hospital, Denmark, we...... identified all adults for whom the treating physician had requested clinical advice on the TDM result for venlafaxine between 2002 and 2012. We identified 1,077 TDM samples of venlafaxine from 334 males and 743 females (median age 45 years), and the median daily dose was 225 mg. Median plasma concentration...... of venlafaxine and o-desmethyvenlafaxine (ODV) were 306 nmol/L and 861 nmol/L, respectively. The median dose-corrected serum level for venlafaxine was 1.49 nmol/L/mg., while the dose-corrected serum level of men and women were 1.21 nmol/L/mg and 1.60 nmol/L/mg, respectively. The dose-corrected sum of venlafaxine...

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

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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

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

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

2018-01-01

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

Buerger's Disease and Anaesthesia: The Neglected Cardiac Angle

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Shagun Bhatia Shah

2015-08-01

Full Text Available Distal limb amputations and respiratory complications are common in patients with Buerger’s disease. Nicotine in cigarette is arrhythmogenic as it blocks cardiac potassium channels. Preoperative Holter ECG monitoring may be useful if preoperative electrocardiogram is normal. If the patient is undergoing major surgery, preservative free lignocaine & amiodarone infusions and a cardioverter defibrillator should be available for the intraoperative cardiac rhythm disturbances.

Comparison of the clinical information provided by the FreeStyle Navigator continuous interstitial glucose monitor versus traditional blood glucose readings.

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McGarraugh, Geoffrey V; Clarke, William L; Kovatchev, Boris P

2010-05-01

The purpose of the analysis was to compare the clinical utility of data from traditional self-monitoring of blood glucose (SMBG) to that of continuous glucose monitoring (CGM). A clinical study of the clinical accuracy of the FreeStyle Navigator CGM System (Abbott Diabetes Care, Alameda, CA), which includes SMBG capabilities, was conducted by comparison to the YSI blood glucose analyzer (YSI Inc., Yellow Springs, OH) using 58 subjects with type 1 diabetes. The Continuous Glucose-Error Grid Analysis (CG-EGA) was used as the analytical tool. Using CG-EGA, the "clinically accurate," "benign errors," and "clinical errors" were 86.8%, 8.7%, and 4.5% for SMBG and 92.7%, 3.7%, and 3.6% for CGM, respectively. If blood glucose is viewed as a process in time, SMBG would provide accurate information about this process 86.8% of the time, whereas CGM would provide accurate information about this process 92.7% of the time (P glucose values than CGM, control of blood glucose involves a system in flux, and CGM provides more detailed insight into the dynamics of that system. In the normal and elevated glucose ranges, the additional information about the direction and rate of glucose change provided by the FreeStyle Navigator CGM System increases the ability to make correct clinical decisions when compared to episodic SMBG tests.

Does the STAF score help detect paroxysmal atrial fibrillation in acute stroke patients?

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Horstmann, S; Rizos, T; Güntner, J; Hug, A; Jenetzky, E; Krumsdorf, U; Veltkamp, R

2013-01-01

Detecting paroxysmal atrial fibrillation (pAF) soon after acute cerebral ischaemia has a major impact on secondary stroke prevention. Recently, the STAF score, a composite of clinical and instrumental findings, was introduced to identify stroke patients at risk of pAF. We aimed to validate this score in an independent study population. Consecutive patients admitted to our stroke unit with acute ischaemic stroke were prospectively enrolled. The diagnostic work-up included neuroimaging, neuroultrasound, baseline 12-channel electrocardiogram (ECG), 24-h Holter ECG, continuous ECG monitoring, and echocardiography. Presence of AF was documented according to the medical history of each patient and after review of 12-lead ECG, 24-h Holter ECG, or continuous ECG monitoring performed during the stay on the ward. Additionally, a telephone follow-up visit was conducted for each patient after 3 months to inquire about newly diagnosed AF. Items for each patient-age, baseline NIHSS, left atrial dilatation, and stroke etiology according to the TOAST criteria - were assessed to calculate the STAF score. Overall, 584 patients were enrolled in our analysis. AF was documented in 183 (31.3%) patients. In multivariable analysis, age, NIHSS, left atrial dilatation, and absence of vascular etiology were independent predictors for AF. The logistic AF-prediction model of the STAF score revealed fair classification accuracy in receiver operating characteristic curve analysis with an area under the curve of 0.84. STAF scores of ≥5 had a sensitivity of 79% and a specificity of 74% for predicting AF. The value of the STAF score for predicting the risk of pAF in stroke patients is limited. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

Relationship between the mismatch of 123I-BMIPP and 201Tl myocardial single-photon emission computed tomography and autonomic nervous system activity in patients with acute myocardial infarction

International Nuclear Information System (INIS)

Yamanaka, Hiroyuki; Suzuki, Takeshi; Kishida, Hiroshi; Nagasawa, Koichi; Takano, Teruo

2006-01-01

The purpose of this study was to elucidate the relationship between the mismatch of thallium-201 (Tl) and iodine-123-beta-methyl-iodophenyl-pentadecanoic acid (BMIPP) myocardial single-photon emission computed tomography (SPECT) and autonomic nervous system activity in myocardial infarction (MI) patients. The subjects were 40 patients (34 males, 6 females) who underwent examinations by 123 I-BMIPP and 201 Tl myocardial SPECT imaging and 24-hour Holter monitoring within a 3-day period 3 weeks after the onset of their first MI. R-R intervals were analyzed every hour over a period of 24 hours by fast Fourier transformation (FFT). High frequency (HF) and low frequency (LF) were defined as markers of cardiac vagal activity in the former and the LF/HF ratio as sympathetic activity. Greater or more extensive decreases in the BMIPP image than that in the Tl image were defined as a positive mismatch. Patients were divided into positive and negative mismatch groups of 20 patients each. There were no significant differences between the 2 groups in age, sex, site of infarction, max CK (creatine kinase), max CK-MB, or left ventricular ejection fraction. The incidences of clinical signs suggesting residual myocardial ischemia were significantly greater in the positive than in the negative mismatch group (P 123 I-BMIPP and 201 Tl myocardial SPECT 3 weeks after a first acute myocardial infarction with uncomplicated moderate or severe heart failure and decreased heart rate variability are related to residual myocardial ischemia. A combined assessment of heart rate variability in 24 hour Holter electrocardiogram (ECG) monitoring and perfusion-metabolism mismatch in 123 I-BMIPP and 201 Tl myocardial SPECT is useful for determining residual myocardial ischemia in the follow-up of those with acute myocardial infarction. (author)

Monitoring in traumatic brain injury.

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Matz, P G; Pitts, L

1997-01-01

In the past several years, improvements in technology have advanced the monitoring capabilities for patients with TBI. The primary goal of monitoring the patient with TBI is to prevent secondary insults to the brain, primarily cerebral ischemia. Cerebral ischemia may occur early and without clinical correlation and portends a poor outcome. Measurement of ICP is the cornerstone of monitoring in the patient with TBI. Monitoring of ICP provides a measurement of CPP and a rough estimation of CBF. However, with alterations in pressure autoregulation, measurement of CPP does not always allow for determination of CBF. To circumvent this problem, direct measurements of CBF can be performed using clearance techniques (133Xe, N2O, Xe-CT) or invasive monitoring techniques (LDF, TDF, NIRS). Although direct and quantitative, clearance techniques do not allow for continuous monitoring. Invasive CBF monitoring techniques are new, and artifactual results can be problematic. The techniques of jugular venous saturation monitoring and TCD are well established and are powerful adjuncts to ICP monitoring. They allow the clinician to monitor cerebral oxygen extraction and blood flow velocity, respectively, for any given CPP. Use of TCD may predict posttraumatic vasospasm before clinical sequelae. Jugular venous saturation monitoring may detect clinically occult episodes of cerebral ischemia and increased oxygen extraction. Jugular venous saturation monitoring optimizes the use of hyperventilation in the treatment of intracranial hypertension. Although PET and SPECT scanning allow direct measurement of CMRO2, these techniques have limited application currently. Similarly, microdialysis is in its infancy but has demonstrated great promise for metabolic monitoring. EEG and SEP are excellent adjuncts to the monitoring arsenal and provide immediate information on current brain function. With improvements in electronic telemetry, functional monitoring by EEG or SEP may become an important

Assessment of three frequently used blood glucose monitoring devices in clinical routine.

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Zueger, Thomas; Schuler, Vanessa; Stettler, Christoph; Diem, Peter; Christ, Emanuel R

2012-07-12

Self-monitoring of blood glucose plays an important role in the management of diabetes and has been shown to improve metabolic control. The use of blood glucose meters in clinical practice requires sufficient reliability to allow adequate treatment. Direct comparison of different blood glucose meters in clinical practice, independent of the manufactures is scarce. We, therefore, aimed to evaluate three frequently used blood glucose meters in daily clinical practice. Capillary blood glucose was measured simultaneous using the following glucose meters: Contour® (Bayer Diabetes Care, Zürich, Switzerland), Accu-Chek® aviva (Roche Diagnostics, Rotkreuz, Switzerland), Free-Style® lite (Abbott Diabetes Care, Baar, Switzerland). The reference method consisted of the HemoCue® Glucose 201+ System (HemoCue® AB, Ängelholm, Sweden) with plasma conversion. The devices were assessed by comparison of the Mean Absolute Relative Differences (MARD), the Clarke Error Grid Analysis (EGA) and the compliance with the International Organization of Standardization criteria (ISO 15197:2003). Capillary blood samples were obtained from 150 patients. MARD was 10.1 ± 0.65%, 7.0 ± 0.62% and 7.8 ± 0.48% for Contour®, Accu-Chek® and Free-Style®, respectively. EGA showed 99.3% (Contour®), 98.7% (Accu-Chek®) and 100% (Free-Style®) of all measurements in zone A and B (clinically acceptable). The ISO criteria were fulfilled by Accu-Chek® (95.3%) and Free-Style® (96%), but not by Contour® (92%). In the present study the three glucose meters provided good agreement with the reference and reliable results in daily clinical routine. Overall, the Free-Style® and Accu-Chek® device slightly outperformed the Contour® device.

Clinical utility of early amplitude integrated EEG in monitoring term newborns at risk of neurological injury

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Paulina A. Toso

2014-04-01

Full Text Available OBJECTIVE: to test the clinical utility of an early amplitude-integrated electroencephalography (aEEG to predict short-term neurological outcome in term newborns at risk of neurology injury. METHODS: this was a prospective, descriptive study. The inclusion criteria were neonatal encephalopathy, neurologic disturbances, and severe respiratory distress syndrome. Sensitivity, specificity, positive and negative predictive values, and likelihood ratio (LR were calculated. Clinical and demographic data were analyzed. Neurological outcome was defined as the sum of clinical, electroimaging, and neuroimaging findings. RESULTS: ten of the 21 monitored infants (48% presented altered short-term neurologic outcome. The aEEG had 90% sensitivity, 82% specificity, 82% positive predictive value, and 90% negative predictive value. The positive LR was 4.95, and the negative LR was 0.12. In three of 12 (25% encephalopathic infants, the aEEG allowed for a better definition of the severity of their condition. Seizures were detected in eight infants (38%, all subclinical at baseline, and none had a normal aEEG background pattern. The status of three infants (43% evolved and required two or more drugs for treatment. CONCLUSIONS: in infants with encephalopathy or other severe illness, aEEG disturbances occur frequently. aEEG provided a better classification of the severity of encephalopathy, detected early subclinical seizures, and allowed for monitoring of the response to treatment. aEEG was a useful tool at the neonatal intensive care unit for predicting poor short-term neurological outcomes for all sick newborn.

Implementation of Out-of-Office Blood Pressure Monitoring in the Netherlands: From Clinical Guidelines to Patients’ Adoption of Innovation

NARCIS (Netherlands)

Carrera, Percivil Melendez; Lambooij, Mattijs S.

2015-01-01

Out-of-office blood pressure monitoring is promoted by various clinical guidelines toward properly diagnosing and effectively managing hypertension and engaging the patient in their care process. In the Netherlands, however, the Dutch cardiovascular risk management (CVRM) guidelines do not

The effects of early antithyroid therapy for endogenous subclinical hyperthyroidism in clinical and heart abnormalities.

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Sgarbi, José A; Villaça, Fábio G; Garbeline, Benito; Villar, Heloísa E; Romaldini, João H

2003-04-01

Subclinical hyperthyroidism has been associated with harmful cardiac effects, but its treatment remains controversial. This study was designed to assess the cardiac effects of the normalization of serum TSH concentration in patients with endogenous subclinical hyperthyroidism. Ten patients (median age, 59 yr; range, 16-72 yr) with normal serum free T(4) and free T(3) concentration and a stable suppression of serum TSH levels were evaluated by Doppler-echocardiography, by standard and 24-h electrocardiography monitoring (Holter), and by the clinical Wayne index. Ten subjects, matched for age and sex, were used as controls. Patients were reevaluated 6 months after achieving stabilized euthyroidism by using methimazole with a median initial dose of 20 mg daily (10-30 mg daily). After reaching euthyroidism, we found a significant decrease in the heart rate (P = 0.008), the total number of beats during 24 h (P = 0.004), and the number of atrial (P = 0.002) and ventricular (P = 0.003) premature beats. Echocardiographical data resulted in a reduction of the left ventricular mass index (P = 0.009), interventricular septum thickness (P = 0.008), and left ventricular posterior wall thickness (P = 0.004) at diastole. Furthermore, the early diastolic peak flow velocity deceleration rate was significantly higher (P = 0.02) in the untreated patients compared with controls. The Wayne clinical index was higher in patients than in controls (P = 0.001) and decreased after treatment (P = 0.004). Serum TSH concentration returned to normal values after 2.5 months (range, 1.0-7.0 months) on methimazole therapy (0.05 vs. 1.42 mU/liter; P = 0.002). Serum free T(4) values were normal in patients before treatment but significantly decreased after reaching the euthyroidism (16.9 vs. 11.5 pmol/liter; P = 0.002). In contrast, serum free T(3) concentration did not differ among the groups. In conclusion, our findings support that early antithyroid therapy should be considered in patients with

Clinical skills: cardiac rhythm recognition and monitoring.

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Sharman, Joanna

With technological advances, changes in provision of healthcare services and increasing pressure on critical care services, ward patients' severity of illness is ever increasing. As such, nurses need to develop their skills and knowledge to care for their client group. Competency in cardiac rhythm monitoring is beneficial to identify changes in cardiac status, assess response to treatment, diagnosis and post-surgical monitoring. This paper describes the basic anatomy and physiology of the heart and its conduction system, and explains a simple and easy to remember process of analysing cardiac rhythms (Resuscitation Council UK, 2000) that can be used in first-line assessment to assist healthcare practitioners in providing care to their patients.

Monitoring Student Immunization, Screening, and Training Records for Clinical Compliance: An Innovative Use of the Institutional Learning Management System.

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Elting, Julie Kientz

2017-12-13

Clinical compliance for nursing students is a complex process mandating them to meet facility employee occupational health requirements for immunization, screening, and training prior to patient contact. Nursing programs monitor clinical compliance with in-house management of student records, either paper or electronic, or by contracting with a vendor specializing in online record tracking. Regardless of method, the nursing program remains fully accountable for student preparation and bears the consequences of errors. This article describes how the institution's own learning management system can be used as an accurate, cost-neutral, user-friendly, and Federal Educational Rights Protection Act-compliant clinical compliance system.

CASE OF DIAGNOSIS OF APICAL FORM OF HYPERTROPHIC CARDIOMYOPATHY WITH A PATIENT WITH PROGRESSIVE ANGINA CLINIC

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N. S. Krylova

2015-01-01

Full Text Available Objective of work: to describe the apical form of hypertrophic cardiomyopathy (AFHC developing under the "mask" of the ischemic heart disease not diagnosed for a long period.Materials and methods. Patient B., 73 y.o., female, was brought to the cardiology department with complains of severe pressing pain behind the breastbone caused with no apparent reason and lasting for over 4 hours. The following examination of the patient was performed: electrocardiography (ECG, echocardiography (EchoCG, Holter ECG monitoring, coronary angiography (CAG, ventriculography.Results. The final diagnosis for the patient was set on the basis of the following readings: ECG data (basic rhythm – atrial fibrillation, left ventricle (LV hypertrophy, negative T-waves in leads V1–6, ST segment depression up to 1–2 mm in leads V4–6, EchoCG (hypertrophy of apical segments of the LV with decreasing of its cavity, moderate dilatation of the left atrium, intraventricular obstruction in the apical third of the LV with the maximum pressure gradient of up to 48 mm Hg., CAG (stenotic lesions of coronary arteries were found, ventriculography (LV volume is not increased, no violations of local contractility, narrowing of the LV cavity in the lower third is observed with thinning in the apex, which indicatesexpressed apical hypertrophy of the LV myocard. AFHC, apical form with moderate obstruction in the lower third of the left ventricle. Stress angina syndrome. CAG and ventriculography were main diagnostic methods that allowed setting the final diagnosis.Conclusion. The clinical case sets forth the peculiarities of diagnostics, therapy, and post-therapy management of patients with this form of AFHC.

Cardiac arrhythmias and left ventricular hypertrophy in systemic hypertension

International Nuclear Information System (INIS)

Sultana, R.; Sultana, N.; Rashid, A.; Rasheed, S.Z.; Ahmed, M.; Ishaq, M.; Samad, A.

2010-01-01

Background: Hypertensive left ventricular hypertrophy (LVH) is associated with increased risk of arrhythmias and mortality. Objective was to investigate the prevalence of cardiac arrhythmias and LVH in systemic hypertension. Methods: In all subjects blood pressure was measured, electrocardiography and echocardiography was done. Holter monitoring and exercise test perform in certain cases. There were 500 hypertensive patients, 156 (31.2%) men and 344 (69%) women >30 years of age in the study. Among them 177 (35.4%) were diabetic, 224 (45%) were dyslipidemia, 188 (37.6%) were smokers, and 14 (3%) had homocysteinemia. Mean systolic BP (SBP) was 180 +- 20 mm Hg and diastolic BP (DBP) was 95 +- 12 in male and female patients. Left ventricular mass index (LVMI) was 119.2 +- 30 2 2gm/m in male while 103 +- 22 gm/m in female patients. Palpitation was seen in 126 (25%) male and 299 (59.8%) female patients. Atrial fibrillation was noted in 108 (21.6%) male and 125 (25%) female patients, 30 (6%) male and 82 (16.4%) female patients had atrial flutter. Ventricular tachycardia was noted in 37 (7.4%) male and 59 (11.8%) female patients. Holter monitoring showed significant premature ventricular contractions (PVC'S) in 109 (21.8%) male and 128 (25.69%) female patients while Holter showed atrial arrhythmias (APC'S) in 89 (17.8%) males and 119 (23.8%) females. Angiography findings diagnosed coronary artery disease in 119 (23.8%) with CAD male and 225 (45%) without CAD while 47 (9.4%) females presented with CAD and 109 (21.8%) without CAD. Conclusion: A significant association has been demonstrated between hypertension and arrhythmias. Diastolic dysfunction of the left ventricle, left atrial size and function, as well as LVH have been suggested as the underlying risk factors for supraventricular, ventricular arrhythmias and sudden death in hypertensives with LVH. (author)

Cardiac arrhythmias and left ventricular hypertrophy in systemic hypertension

Energy Technology Data Exchange (ETDEWEB)

Sultana, R; Sultana, N; Rashid, A; Rasheed, S Z; Ahmed, M; Ishaq, M; Samad, A [Karachi Institute of Heart Diseases, Karachi (Pakistan)

2010-10-15

Background: Hypertensive left ventricular hypertrophy (LVH) is associated with increased risk of arrhythmias and mortality. Objective was to investigate the prevalence of cardiac arrhythmias and LVH in systemic hypertension. Methods: In all subjects blood pressure was measured, electrocardiography and echocardiography was done. Holter monitoring and exercise test perform in certain cases. There were 500 hypertensive patients, 156 (31.2%) men and 344 (69%) women >30 years of age in the study. Among them 177 (35.4%) were diabetic, 224 (45%) were dyslipidemia, 188 (37.6%) were smokers, and 14 (3%) had homocysteinemia. Mean systolic BP (SBP) was 180 +- 20 mm Hg and diastolic BP (DBP) was 95 +- 12 in male and female patients. Left ventricular mass index (LVMI) was 119.2 +- 30 2 2gm/m in male while 103 +- 22 gm/m in female patients. Palpitation was seen in 126 (25%) male and 299 (59.8%) female patients. Atrial fibrillation was noted in 108 (21.6%) male and 125 (25%) female patients, 30 (6%) male and 82 (16.4%) female patients had atrial flutter. Ventricular tachycardia was noted in 37 (7.4%) male and 59 (11.8%) female patients. Holter monitoring showed significant premature ventricular contractions (PVC'S) in 109 (21.8%) male and 128 (25.69%) female patients while Holter showed atrial arrhythmias (APC'S) in 89 (17.8%) males and 119 (23.8%) females. Angiography findings diagnosed coronary artery disease in 119 (23.8%) with CAD male and 225 (45%) without CAD while 47 (9.4%) females presented with CAD and 109 (21.8%) without CAD. Conclusion: A significant association has been demonstrated between hypertension and arrhythmias. Diastolic dysfunction of the left ventricle, left atrial size and function, as well as LVH have been suggested as the underlying risk factors for supraventricular, ventricular arrhythmias and sudden death in hypertensives with LVH. (author)

Durable usage of patient-reported outcome measures in clinical practice to monitor health-related quality of life in head and neck cancer patients.

Science.gov (United States)

Duman-Lubberding, S; van Uden-Kraan, C F; Jansen, F; Witte, B I; Eerenstein, S E J; van Weert, S; de Bree, R; Leemans, C R; Verdonck-de Leeuw, I M

2017-12-01

To investigate the long-term follow-up (5 years) of implementing patient-reported outcome measures (PROMs) in clinical practice to monitor health-related quality of life (HRQOL) in head and neck cancer (HNC) patients. A mixed method design was used. The usage rate of OncoQuest (a touch screen computer system to monitor HRQOL) and the subsequent nurse consultation was calculated among HNC patients who visited the outpatient clinic for regular follow-up, as well as differences between ever users and never users (sociodemographic and clinical characteristics). The content of the nurse consultation was investigated. Reasons for not using (barriers) or using (facilitators) OncoQuest and the nurse consultation were explored from the perspective of HNC patients, and of head and neck surgeons. Usage rate of OncoQuest was 67% and of the nurse consultation 79%. Usage of OncoQuest was significantly related to tumor subsite and tumor stage. Topics most frequently (>40%) discussed during the nurse consultation were global quality of life (97%), head and neck cancer related symptoms (82%), other physical symptoms such as pain (61%), and psychological problems such as anxiety (44%). Several barriers and facilitators to implement PROMs in clinical practice were reported by both patients and head and neck surgeons. Usage of PROMs in clinical practice and a nurse consultation is durable, even 5 years after the introduction. This study contributes to better insight into long-term follow-up of implementation, thereby guiding future research and projects that aim to implement PROMs in clinical practice to monitor HRQOL among (head and neck) cancer patients.

Quantifying temporal glucose variability in diabetes via continuous glucose monitoring: mathematical methods and clinical application.

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Kovatchev, Boris P; Clarke, William L; Breton, Marc; Brayman, Kenneth; McCall, Anthony

2005-12-01

Continuous glucose monitors (CGMs) collect detailed blood glucose (BG) time series, which carry significant information about the dynamics of BG fluctuations. In contrast, the methods for analysis of CGM data remain those developed for infrequent BG self-monitoring. As a result, important information about the temporal structure of the data is lost during the translation of raw sensor readings into clinically interpretable statistics and images. The following mathematical methods are introduced into the field of CGM data interpretation: (1) analysis of BG rate of change; (2) risk analysis using previously reported Low/High BG Indices and Poincare (lag) plot of risk associated with temporal BG variability; and (3) spatial aggregation of the process of BG fluctuations and its Markov chain visualization. The clinical application of these methods is illustrated by analysis of data of a patient with Type 1 diabetes mellitus who underwent islet transplantation and with data from clinical trials. Normative data [12,025 reference (YSI device, Yellow Springs Instruments, Yellow Springs, OH) BG determinations] in patients with Type 1 diabetes mellitus who underwent insulin and glucose challenges suggest that the 90%, 95%, and 99% confidence intervals of BG rate of change that could be maximally sustained over 15-30 min are [-2,2], [-3,3], and [-4,4] mg/dL/min, respectively. BG dynamics and risk parameters clearly differentiated the stages of transplantation and the effects of medication. Aspects of treatment were clearly visualized by graphs of BG rate of change and Low/High BG Indices, by a Poincare plot of risk for rapid BG fluctuations, and by a plot of the aggregated Markov process. Advanced analysis and visualization of CGM data allow for evaluation of dynamical characteristics of diabetes and reveal clinical information that is inaccessible via standard statistics, which do not take into account the temporal structure of the data. The use of such methods improves the

Limits to the Evaluation of the Accuracy of Continuous Glucose Monitoring Systems by Clinical Trials.

Science.gov (United States)

Schrangl, Patrick; Reiterer, Florian; Heinemann, Lutz; Freckmann, Guido; Del Re, Luigi

2018-05-18

Systems for continuous glucose monitoring (CGM) are evolving quickly, and the data obtained are expected to become the basis for clinical decisions for many patients with diabetes in the near future. However, this requires that their analytical accuracy is sufficient. This accuracy is usually determined with clinical studies by comparing the data obtained by the given CGM system with blood glucose (BG) point measurements made with a so-called reference method. The latter is assumed to indicate the correct value of the target quantity. Unfortunately, due to the nature of the clinical trials and the approach used, such a comparison is subject to several effects which may lead to misleading results. While some reasons for the differences between the values obtained with CGM and BG point measurements are relatively well-known (e.g., measurement in different body compartments), others related to the clinical study protocols are less visible, but also quite important. In this review, we present a general picture of the topic as well as tools which allow to correct or at least to estimate the uncertainty of measures of CGM system performance.

Clinical validation of a medical grade color monitor for chest radiology

Science.gov (United States)

Jacobs, J.; Zanca, F.; Verschakelen, J.; Marchal, G.; Bosmans, H.

2009-02-01

Until recently, the specifications of medical grade monochrome LCD monitors outperformed those of color LCD monitors. New generations of color LCD monitors, however, show specifications that are in many respects similar to those of monochrome monitors typically used in diagnostic workstations. The aim of present study was to evaluate the impact of different medical grade monitors in terms of detection of simulated lung nodules in chest x-ray images. Specifically, we wanted to compare a new medical grade color monitor (Barco Coronis 6MP color) to a medical grade grayscale monitor (Barco Coronis 3MP monochrome) and a consumer color monitor (Philips 200VW 1.7MP color) by means of an observer performance experiment. Using the free-response acquisition data paradigm, seven radiologists were asked to detect and locate lung nodules (170 in total), simulated in half of the 200 chest X-ray images used in the experiment. The jackknife free-response receiver operating characteristic (JAFROC) analysis of the data showed a statistically significant difference between at least two monitors, F-value=3.77 and p-value =0.0481. The different Figure of Merit values were 0.727, 0.723 and 0.697 for the new color LCD monitor, the medical grade monitor and the consumer color monitor respectively. There was no difference between the needed reading times but there was a difference between the mean calculated Euclidian distances between the position marked by the observers and the center of the simulated nodule, indicating a better accuracy with both medical grade monitors. Present data suggests that the new generation of medical grade color monitors could be used as diagnostic workstations.

Features of conngestive heart failure development in patients with post infarct cardiosclerosis concomitant with arrhythmias

International Nuclear Information System (INIS)

Zharov, E.I.; Martynov, A.I.; Vertkin, A.L.; Sergeeva, L.I.; Sedov, V.P.

1989-01-01

Two hundred and seventy seven patients with coronary heart disease, includng 182 with postinfarction cardiosclerosis undewent 24-hour Holter monitoring. A significant correlation was found between the number of coupled ventricular arrhythmias, ventricular tachycardia paroxysms and developmet of congestive heart failure in patients with postinfarct cardiosclerosis. With evolving metabolic deficiency as evidenced by thallium-201 myocardial scintigraphy, the incidence of congestive heart failure and ventricular arrhythmias increased among the patients

Safety measurement and monitoring in healthcare: a framework to guide clinical teams and healthcare organisations in maintaining safety

Science.gov (United States)

Vincent, Charles; Burnett, Susan; Carthey, Jane

2014-01-01

Patients, clinicians and managers all want to be reassured that their healthcare organisation is safe. But there is no consensus about what we mean when we ask whether a healthcare organisation is safe or how this is achieved. In the UK, the measurement of harm, so important in the evolution of patient safety, has been neglected in favour of incident reporting. The use of softer intelligence for monitoring and anticipation of problems receives little mention in official policy. The Francis Inquiry report into patient treatment at the Mid Staffordshire NHS Foundation Trust set out 29 recommendations on measurement, more than on any other topic, and set the measurement of safety an absolute priority for healthcare organisations. The Berwick review found that most healthcare organisations at present have very little capacity to analyse, monitor or learn from safety and quality information. This paper summarises the findings of a more extensive report and proposes a framework which can guide clinical teams and healthcare organisations in the measurement and monitoring of safety and in reviewing progress against safety objectives. The framework has been used so far to promote self-reflection at both board and clinical team level, to stimulate an organisational check or analysis in the gaps of information and to promote discussion of ‘what could we do differently’. PMID:24764136

Impact of space weather on human heart rate during the years 2011-2013

Science.gov (United States)

Galata, E.; Ioannidou, S.; Papailiou, M.; Mavromichalaki, H.; Paravolidakis, K.; Kouremeti, M.; Rentifis, L.; Simantirakis, E.; Trachanas, K.

2017-08-01

During the last years a possible link between different levels of solar and geomagnetic disturbances and human physiological parameters is suggested by several published studies. In this work the examination of the potential association between heart rate variations and specific space weather activities was performed. A total of 482 individuals treated at Hippocratio General Hospital in Athens, the Cardiology clinics of Nikaia General Hospital in Piraeus and the Heraklion University Hospital in Crete, Greece, were assessed from July 2011 to April 2013. The heart rate of the individuals was recorded by a Holter monitor on a n hourly basis, while the hourly variations of the cosmic ray intensity measured by the Neutron Monitor Station of the Athens University and of the geomagnetic index Dst provided by the Kyoto Observatory were used. The ANalysis Of VAriance (ANOVA) and the Multiple Linear Regression analysis were used for analysis of these data. A statistically significant effect of both cosmic rays and geomagnetic activity on heart rate was observed, which may indicate that changes in space weather could be linked to heart rate variations.

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.

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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.

Immunological monitoring for prediction of clinical response to antitumor vaccine therapy.

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Mikhaylova, Irina N; Shubina, Irina Zh; Chkadua, George Z; Petenko, Natalia N; Morozova, Lidia F; Burova, Olga S; Beabelashvili, Robert Sh; Parsunkova, Kermen A; Balatskaya, Natalia V; Chebanov, Dmitrii K; Pospelov, Vadim I; Nazarova, Valeria V; Vihrova, Anastasia S; Cheremushkin, Evgeny A; Molodyk, Alvina A; Kiselevsky, Mikhail V; Demidov, Lev V

2018-05-11

Immunotherapy has shown promising results in a variety of cancers, including melanoma. However, the responses to therapy are usually heterogeneous, and understanding the factors affecting clinical outcome is still not achieved. Here, we show that immunological monitoring of the vaccine therapy for melanoma patients may help to predict the clinical course of the disease. We studied cytokine profile of cellular Th1 (IL-2, IL-12, IFN-γ) and humoral Th2 (IL-4, IL-10) immune response, vascular endothelial growth factor (VEGFA), transforming growth factor-β 2 (TGF-β 2), S100 protein (S100A1B and S100BB), adhesion molecule CD44 and serum cytokines β2-microglobulin to analyze different peripheral blood mononuclear cell subpopuations of patients treated with dendritic vaccines and/or cyclophosphamide in melanoma patients in the course of adjuvant treatment. The obtained data indicate predominance of cellular immunity in the first adjuvant group of patients with durable time to progression and shift to humoral with low cellular immunity in patients with short-term period to progression (increased levels of IL-4 and IL- 10). Beta-2 microglobulin was differentially expressed in adjuvant subgroups: its higher levels correlated with shorter progression-free survival and the total follow-up time. Immunoregulatory index was overall higher in patients with disease progression compared to the group of patients with no signs of disease progression.

Monitoring and evaluation of sustained clinical performance and tuberculosis management in the South African mining industry

CSIR Research Space (South Africa)

Murray, J

2004-03-01

Full Text Available Advisory Committee Project Summary : SIM 02-08-02 Project Title: MONITORING AND EVALUATION OF SUSTAINED CLINICAL PERFORMANCE AND TUBERCULOSIS MANAGEMENT IN THE SA MINING INDUSTRY (22 pages) Author(s): Dr Jill Murray Dr Michelle Wong...-orientated data analyses. It was then possible to quantify the high proportion of pulmonary tuberculosis in miners that appeared to be undiagnosed during life (˜ 60%). SIMRAC Health 611 clearly demonstrated that significant problems exist with regard...

Accuracy of a radiofrequency identification (RFID) badge system to monitor hand hygiene behavior during routine clinical activities.

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Pineles, Lisa L; Morgan, Daniel J; Limper, Heather M; Weber, Stephen G; Thom, Kerri A; Perencevich, Eli N; Harris, Anthony D; Landon, Emily

2014-02-01

Hand hygiene (HH) is a critical part of infection prevention in health care settings. Hospitals around the world continuously struggle to improve health care personnel (HCP) HH compliance. The current gold standard for monitoring compliance is direct observation; however, this method is time-consuming and costly. One emerging area of interest involves automated systems for monitoring HH behavior such as radiofrequency identification (RFID) tracking systems. To assess the accuracy of a commercially available RFID system in detecting HCP HH behavior, we compared direct observation with data collected by the RFID system in a simulated validation setting and to a real-life clinical setting over 2 hospitals. A total of 1,554 HH events was observed. Accuracy for identifying HH events was high in the simulated validation setting (88.5%) but relatively low in the real-life clinical setting (52.4%). This difference was significant (P RFID system, almost half of the HH events were missed. More research is necessary to further develop these systems and improve accuracy prior to widespread adoption. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

High-throughput monitoring of integration site clonality in preclinical and clinical gene therapy studies

Directory of Open Access Journals (Sweden)

Frank A Giordano

Full Text Available Gene transfer to hematopoietic stem cells with integrating vectors not only allows sustained correction of monogenic diseases but also tracking of individual clones in vivo. Quantitative real-time PCR (qPCR has been shown to be an accurate method to quantify individual stem cell clones, yet due to frequently limited amounts of target material (especially in clinical studies, it is not useful for large-scale analyses. To explore whether vector integration site (IS recovery techniques may be suitable to describe clonal contributions if combined with next-generation sequencing techniques, we designed artificial ISs of different sizes which were mixed to simulate defined clonal situations in clinical settings. We subjected all mixes to either linear amplification–mediated PCR (LAM-PCR or nonrestrictive LAM-PCR (nrLAM-PCR, both combined with 454 sequencing. We showed that nrLAM-PCR/454-detected clonality allows estimating qPCR-detected clonality in vitro. We then followed the kinetics of two clones detected in a patient enrolled in a clinical gene therapy trial using both, nrLAM-PCR/454 and qPCR and also saw nrLAM-PCR/454 to correlate to qPCR-measured clonal contributions. The method presented here displays a feasible high-throughput strategy to monitor clonality in clinical gene therapy trials is at hand.

Initial clinical evaluation of PET-based ion beam therapy monitoring under consideration of organ motion.

Science.gov (United States)

Kurz, Christopher; Bauer, Julia; Unholtz, Daniel; Richter, Daniel; Herfarth, Klaus; Debus, Jürgen; Parodi, Katia

2016-02-01

Intrafractional organ motion imposes considerable challenges to scanned ion beam therapy and demands for a thorough verification of the applied treatment. At the Heidelberg Ion-Beam Therapy Center (HIT), the scanned ion beam delivery is verified by means of postirradiation positron-emission-tomography (PET) imaging. This work presents a first clinical evaluation of PET-based treatment monitoring in ion beam therapy under consideration of target motion. Three patients with mobile liver lesions underwent scanned carbon ion irradiation at HIT and postirradiation PET/CT (x-ray-computed-tomography) imaging with a commercial scanner. Respiratory motion was recorded during irradiation and subsequent image acquisition. This enabled a time-resolved (4D) calculation of the expected irradiation-induced activity pattern and, for one patient where an additional 4D CT was acquired at the PET/CT scanner after treatment, a motion-compensated PET image reconstruction. For the other patients, PET data were reconstructed statically. To verify the treatment, calculated prediction and reconstructed measurement were compared with a focus on the ion beam range. Results in the current three patients suggest that for motion amplitudes in the order of 2 mm there is no benefit from incorporating respiratory motion information into PET-based treatment monitoring. For a target motion in the order of 10 mm, motion-related effects become more severe and a time-resolved modeling of the expected activity distribution can lead to an improved data interpretation if a sufficient number of true coincidences is detected. Benefits from motion-compensated PET image reconstruction could not be shown conclusively at the current stage. The feasibility of clinical PET-based treatment verification under consideration of organ motion has been shown for the first time. Improvements in noise-robust 4D PET image reconstruction are deemed necessary to enhance the clinical potential.

Initial clinical evaluation of PET-based ion beam therapy monitoring under consideration of organ motion

International Nuclear Information System (INIS)

Kurz, Christopher; Bauer, Julia; Unholtz, Daniel; Herfarth, Klaus; Debus, Jürgen; Richter, Daniel; Parodi, Katia

2016-01-01

Purpose: Intrafractional organ motion imposes considerable challenges to scanned ion beam therapy and demands for a thorough verification of the applied treatment. At the Heidelberg Ion-Beam Therapy Center (HIT), the scanned ion beam delivery is verified by means of postirradiation positron-emission-tomography (PET) imaging. This work presents a first clinical evaluation of PET-based treatment monitoring in ion beam therapy under consideration of target motion. Methods: Three patients with mobile liver lesions underwent scanned carbon ion irradiation at HIT and postirradiation PET/CT (x-ray-computed-tomography) imaging with a commercial scanner. Respiratory motion was recorded during irradiation and subsequent image acquisition. This enabled a time-resolved (4D) calculation of the expected irradiation-induced activity pattern and, for one patient where an additional 4D CT was acquired at the PET/CT scanner after treatment, a motion-compensated PET image reconstruction. For the other patients, PET data were reconstructed statically. To verify the treatment, calculated prediction and reconstructed measurement were compared with a focus on the ion beam range. Results: Results in the current three patients suggest that for motion amplitudes in the order of 2 mm there is no benefit from incorporating respiratory motion information into PET-based treatment monitoring. For a target motion in the order of 10 mm, motion-related effects become more severe and a time-resolved modeling of the expected activity distribution can lead to an improved data interpretation if a sufficient number of true coincidences is detected. Benefits from motion-compensated PET image reconstruction could not be shown conclusively at the current stage. Conclusions: The feasibility of clinical PET-based treatment verification under consideration of organ motion has been shown for the first time. Improvements in noise-robust 4D PET image reconstruction are deemed necessary to enhance the

Numerical and clinical precision of continuous glucose monitoring in Colombian patients treated with insulin infusion pump with automated suspension in hypoglycemia.

Science.gov (United States)

Gómez, Ana M; Marín Sánchez, Alejandro; Muñoz, Oscar M; Colón Peña, Christian Alejandro

2015-12-01

Insulin pump therapy associated with continuous glucose monitoring has shown a positive clinical impact on diabetes control and reduction of hypoglycemia episodes. There are descriptions of the performance of this device in other populations, but its precision and accuracy in Colombia and Latin America are unknown, especially in the routine outpatient setting. Data from 33 type 1 and type 2 diabetes patients with sensor-augmented pump therapy with threshold suspend automation, MiniMed Paradigm® Veo™ (Medtronic, Northridge, California), managed at Hospital Universitario San Ignacio (Bogotá, Colombia) and receiving outpatient treatment, were analyzed. Simultaneous data from continuous glucose monitoring and capillary blood glucose were compared, and their precision and accuracy were calculating with different methods, including Clarke error grid. Analyses included 2,262 continuous glucose monitoring -reference paired glucose values. A mean absolute relative difference of 20.1% was found for all measurements, with a value higher than 23% for glucose levels ≤75mg/dL. Global compliance with the ISO criteria was 64.9%. It was higher for values >75mg/dl (68.3%, 1,308 of 1,916 readings), than for those ≤ 75mg/dl (49.4%, 171 of 346 readings). Clinical accuracy, as assessed by the Clarke error grid, showed that 91.77% of data were within the A and B zones (75.6% in hypoglycemia). A good numerical accuracy was found for continuous glucose monitoring in normo and hyperglycemia situations, with low precision in hypoglycemia. The clinical accuracy of the device was adequate, with no significant safety concerns for patients. Copyright © 2015 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study.

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Balsam, Paweł; Lodziński, Piotr; Tymińska, Agata; Ozierański, Krzysztof; Januszkiewicz, Łukasz; Główczyńska, Renata; Wesołowska, Katarzyna; Peller, Michał; Pietrzak, Radosław; Książczyk, Tomasz; Borodzicz, Sonia; Kołtowski, Łukasz; Borkowski, Mariusz; Werner, Bożena; Opolski, Grzegorz; Grabowski, Marcin

2018-01-01

Today, the main challenge for researchers is to develop new technologies which may help to improve the diagnoses of cardiovascular disease (CVD), thereby reducing healthcare costs and improving the quality of life for patients. This study aims to show the utility of biomedical shirt-based electrocardiography (ECG) monitoring of patients with CVD in different clinical situations using the Nuubo® ECG (nECG) system. An investigator-initiated, multicenter, prospective observational study was carried out in a cardiology (adult and pediatric) and cardiac rehabilitation wards. ECG monitoring was used with the biomedical shirt in the following four independent groups of patients: 1) 30 patients after pulmonary vein isolation (PVI), 2) 30 cardiac resynchronization therapy (CRT) recipients, 3) 120 patients during cardiac rehabilitation after myocardial infarction, and 4) 40 pediatric patients with supraventricular tachycardia (SVT) before electrophysiology study. Approval for all study groups was obtained from the institutional review board. The biomedical shirt captures the electrocardiographic signal via textile electrodes integrated into a garment. The software allows the visualization and analysis of data such as ECG, heart rate, arrhythmia detecting algorithm and relative position of the body is captured by an electronic device. The major advantages of the nECG system are continuous ECG monitoring during daily activities, high quality of ECG recordings, as well as assurance of a proper adherence due to adequate comfort while wearing the shirt. There are only a few studies that have examined wearable systems, especially in pediatric populations. This study is registered in ClinicalTrials.gov: Identifier NCT03068169. (Cardiol J 2018; 25, 1: 52-59).

Point-of-care coagulation monitoring: first clinical experience using a paper-based lateral flow diagnostic device.

Science.gov (United States)

Hegener, Michael A; Li, Hua; Han, Daewoo; Steckl, Andrew J; Pauletti, Giovanni M

2017-09-01

Vitamin K antagonists such as warfarin are the most widely used class of oral anticoagulants. Due to a narrow therapeutic window, patients on warfarin require regular monitoring. Self-testing using point-of-care (POC) diagnostic devices is available, but cost makes this monitoring method beyond reach for many. The main objective of this research was to assess the clinical utility of a low-cost, paper-based lateral flow POC diagnostic device developed for anticoagulation monitoring without the need for a separate electronic reader. Custom-fabricated lateral flow assay (LFA) test strips comprised of a glass fiber sample pad, a nitrocellulose analytical membrane, a cellulose wicking pad, and a plastic backing card were assembled in a plastic cassette. Healthy volunteers and patients on warfarin therapy were recruited for this prospective study. For each participant, a whole blood sample was collected via fingerstick to determine: (1) international normalized ratio (INR) using the CoaguChek® XS coagulometer, (2) hematocrit by centrifugation, and (3) red blood cell (RBC) travel distance on the experimental LFA device after 240 s using digital image analysis. RBC travel distance measured on the LFA device using blood samples obtained from warfarin patients positively correlated with increasing INR value and the LFA device had the capability to statistically distinguish between healthy volunteer INR values and those for patients groups with INR ≥ 2.6. From these data, it is predicted that this low-cost, paper-based LFA device can have clinical utility for identifying anticoagulated patients taking vitamin K antagonists who are outside of the desired therapeutic efficacy window.

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

Science.gov (United States)

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

2017-11-25

Monitoring fungal aerocontamination is an essential measure to prevent severe invasive aspergillosis (IA) infections in hospitals. One central block among 32 blocks of Edouard Herriot Hospital (EHH) was entirely demolished in 2015, while care activities continued in surrounding blocks. The main objective was to undertake broad environmental monitoring and clinical surveillance of IA cases to document fungal dispersion during major deconstruction work and to assess clinical risk. A daily environmental survey of fungal loads was conducted in eight wards located near the demolition site. Air was collected inside and outside selected wards by agar impact samplers. Daily spore concentrations were monitored continuously by volumetric samplers at a flow rate of 10 L.min -1 . Daily temperature, wind direction and speed as well as relative humidity were recorded by the French meteorological station Meteociel. Aspergillus fumigatus strains stored will be genotyped by multiple-locus, variable-number, tandem-repeat analysis. Antifungal susceptibility will be assessed by E-test strips on Roswell Park Memorial Institute medium supplemented with agar. Ascertaining the adequacy of current environmental monitoring techniques in hospital is of growing importance, considering the rising impact of fungal infections and of curative antifungal costs. The present study could improve the daily management of IA risk during major deconstruction work and generate new data to ameliorate and redefine current guidelines. This study was approved by the clinical research and ethics committees of EHH. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Clinical usefulness of 123I-MIBG myocardial spect in patients with cardiac sarcoidosis

International Nuclear Information System (INIS)

Kobayashi, Keiko; Hatsumi, Chie; Fujioka, Haruto

1996-01-01

This study was undertaken to assess whether 123 I-MIBG scintigraphy is useful to detect cardiac involvements of sarcoidosis. In 45 patients with sarcoidosis, dual SPECT with 123 I-MIBG and 201 Tl-Cl(Tl) were performed, and the findings were compared with electrocardiogram (ECG), 24 hour Holter ECG and ultrasound echocardiography. In order to evaluate cardiac involvements, Tl and MIBG extent score (E.S.) and severity score (S.S.) were calculated by a Bull's eye map in addition to visual evaluation. Abnormal findings were recognized in 8.9% of all subjects in echocardiography, in 22.2% of those in ECG and Holter ECG, in 40% of those in Tl scintigraphy, and in 64.4% of those in MIBG scintigraphy. All of the Tl and MIBG abnormalities were detected in left ventricles, especially at the basal septal wall. At the inferior wall, abnormalities were observed more frequently by MIBG than by Tl. Tl E.S., Tl S.S. and MIBG E.S. were significantly higher in 10 patients with abnormal ECG findings than in 35 patients with normal ECG findings. Also, all of 10 patients with abnormal ECG findings had abnormal MIBG image, but 3 of them showed normal Tl images. 11 of 35 patients with normal ECG findings showed abnormal Tl and MIBG images (group A), 8 of 35 patients showed normal Tl images and abnormal MIBG images (group B), and 16 of 35 patients showed normal Tl and MIBG images (group C). MIBG S.S. of group A (11.3±7.8) was significantly higher than that of group B (5.3±3.1) or group C (2.6±3.2). Furthermore, in group A, MIBG S.S. was significantly higher than Tl S.S. (5.5±2.8). In a case of normal ECG with abnormal MIBG images, we seriously suspect cardiac involvements and recommend repeated Holter ECG tests as necessary in order to detect critical arrythmia. MIBG scintigraphy appeared to be a sensitive and useful method for the early detection of cardiac sarcoidosis. (J.P.N.)

Clinical long-term outcome of septal myectomy for obstructive hypertrophic cardiomyopathy in infants.

Science.gov (United States)

Schleihauf, Julia; Cleuziou, Julie; Pabst von Ohain, Jelena; Meierhofer, Christian; Stern, Heiko; Shehu, Nerejda; Mkrtchyan, Naira; Kaltenecker, Emanuel; Kühn, Andreas; Nagdyman, Nicole; Hager, Alfred; Seidel, Heide; Lange, Rüdiger; Ewert, Peter; Wolf, Cordula M

2018-03-01

Surgical septal myectomy is performed to relieve left ventricular outflow tract narrowing in severe drug-refractory obstructive hypertrophic cardiomyopathy. The objective of this study was to assess the perioperative and long-term clinical outcome of this procedure performed during infancy. Clinical, transthoracic echocardiographic, electrocardiographic, 24-h Holter, cardiopulmonary exercise test and genetic data were extracted by medical record review. A subset of patients underwent additional prospective detailed clinical evaluation including cardiac magnetic resonance imaging with contrast. Surgery was performed in 23 paediatric patients between 1978 and 2015 at the German Heart Centre Munich. Twelve patients had undergone surgery during infancy (≤ 1 year) (Group A), 11 between 1 and 18 years of age (Group B). The underlying genetic diagnosis was Noonan syndrome spectrum and non-syndromic hypertrophic cardiomyopathy. As compared to Group B, patients in Group A showed more concomitant cardiac procedures and received more homologous transfusions. One perioperative death occurred in Group A, and none in Group B. Two patients in Group A but no patient in Group B required redo septal myectomy. The long-term clinical outcome was similar between the 2 groups. One patient in Group B required cardioverter-defibrillator/pacemaker implantation for higher degree atrioventricular block and none in Group A. There was no evidence of differences in myocardial fibrosis between groups on long-term follow-up magnetic resonance imaging. Surgical septal myectomy can be performed safely during infancy with favourable perioperative and long-term clinical outcome but with a trend towards a higher reoperation rate later in life. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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

Science.gov (United States)

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

2012-10-01

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

A mobile and web-based clinical decision support and monitoring system for diabetes mellitus patients in primary care: a study protocol for a randomized controlled trial.

Science.gov (United States)

Kart, Özge; Mevsim, Vildan; Kut, Alp; Yürek, İsmail; Altın, Ayşe Özge; Yılmaz, Oğuz

2017-11-29

Physicians' guideline use rates for diagnosis, treatment and monitoring of diabetes mellitus (DM) is very low. Time constraints, patient overpopulation, and complex guidelines require alternative solutions for real time patient monitoring. Rapidly evolving e-health technology combined with clinical decision support and monitoring systems (CDSMS) provides an effective solution to these problems. The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for the screening, diagnosis, treatment, and monitoring of DM diseases which is used by physicians and patients in primary care and to determine the effectiveness of the system. The CDSMS will be based on evidence-based guidelines for DM disease. A web and mobile-based application will be developed in which the physician will remotely monitor patient data through mobile applications in real time. The developed CDSMS will be tested in two stages. In the first stage, the usability, understandability, and adequacy of the application will be determined. Five primary care physicians will use the developed application for at least 16 DM patients. Necessary improvements will be made according to physician feedback. In the second phase, a parallel, single-blind, randomized controlled trial will be implemented. DM diagnosed patients will be recruited for the CDSMS trial by their primary care physicians. Ten physicians and their 439 patients will be involved in the study. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p system will make recommendations on patient monitoring, diagnosis, and treatment. These recommendations will be implemented at the physician's discretion. Patients in the control group will be treated by physicians according to current DM treatment standards. Patients in both groups will be monitored for 6�

Principles and strategies for monitoring data collection integrity in a multi-site randomized clinical trial of a behavioral intervention.

Science.gov (United States)

Phillips-Salimi, Celeste R; Donovan Stickler, Molly A; Stegenga, Kristin; Lee, Melissa; Haase, Joan E

2011-08-01

Although treatment fidelity strategies for enhancing the integrity of behavioral interventions have been well described, little has been written about monitoring data collection integrity. This article describes the principles and strategies developed to monitor data collection integrity of the "Stories and Music for Adolescent/Young Adult Resilience During Transplant" study (R01NR008583, U10CA098543, and U10CA095861)-a multi-site Children's Oncology Group randomized clinical trial of a music therapy intervention for adolescents and young adults undergoing stem cell transplant. The principles and strategies outlined in this article provide one model for development and evaluation of a data collection integrity monitoring plan for behavioral interventions that may be adapted by investigators and may be useful to funding agencies and grant application reviewers in evaluating proposals. Copyright © 2011 Wiley Periodicals, Inc.

Evaluation of a clinic-based cholinesterase test kit for the Washington State Cholinesterase Monitoring Program.

Science.gov (United States)

Hofmann, Jonathan N; Carden, Angela; Fenske, Richard A; Ruark, Harold E; Keifer, Matthew C

2008-07-01

The Washington State Cholinesterase Monitoring Program for pesticide handlers requires blood draws at local clinics, with samples tested at a central laboratory. At present, workers with inhibited cholinesterase activity may be re-exposed before they can be removed from work. In this study we explored the option of on-site testing at local clinics using the EQM Test-mate Kittrade mark, a portable cholinesterase test kit. Test kit cholinesterase activity measurements were performed on 50 blood samples by our research staff, and compared to measurements on the same samples by the Washington State Public Health Laboratory. Another set of samples was also analyzed with the test kit by medical staff at an eastern Washington clinic. Triplicate measurements with the test kit had a 3.3% average coefficient of variation (CV) for plasma cholinesterase (PChE), and a 3.5% average CV for erythrocyte cholinesterase (AChE) measurements. The kit's PChE measurements were similar to PHL measurements (average ratio of 0.98) when performed in the laboratory, but had a tendency to underestimate activity when used in the clinic setting (average ratio of 0.87). The kit systematically overestimated AChE activity by 42-48% relative to the PHL measurements, regardless of where the samples were analyzed. This easy-to-use test kit appeared to be a viable method for clinic-based PChE measurements, but was less consistent for AChE measurements performed in the clinic. Absolute measurements with the kit need to be evaluated carefully relative to standardized methods. (c) 2008 Wiley-Liss, Inc.

[Clinical utility of home blood pressure monitoring in patients under treatment].

Science.gov (United States)

Bauk, L; Costa, H A; Caligiuri, S I

2015-01-01

A low number of patients who are treated with antihypertensive drugs achieve therapeutic goals. Home blood pressure monitoring is an excellent tool for studying this population. To determine the prevalence of patients with controlled and uncontrolled hypertension, as well as white-coat-effect and masked hypertension, and to evaluate the relationship with target organ damage in different groups. Blood pressure readings were performed simultaneously in the clinic and in the home using the same validated oscillometric equipment on 83 hypertensive patients on treatment with 2 or more antihypertensive drugs. They were then classified into 4 groups according to the cut-off values of the clinic and home blood pressure measurements. Left ventricular mass index, carotid intima media thickness, and microalbuminuria as markers of target organ damage, were also evaluated. Controlled blood pressure was present in 32.5%, 30.2% had sustained hypertension. The white coat effect was seen in 26.5%, while 10.8% were masked uncontrolled hypertension. Left ventricular mass index was higher in patients with no ambulatory control compared to controlled patients, and carotid IMT was also higher too in uncontrolled and white coat effect groups than controlled patients. More than one third of our patients who were treated with 2 or more drugs were not properly controlled, and they had significantly greater target organ damage than controlled patients. Copyright © 2014 SEHLELHA. Published by Elsevier Espana. All rights reserved.

Diagnostic Dilemma of Cardiac Syncope in Pediatric Patients

Directory of Open Access Journals (Sweden)

Ranya A Hegazy

2008-02-01

Full Text Available Aims Syncope is defined as temporary loss of consciousness and postural tone resulting from an abrupt transient decrease in cerebral blood flow. The present work aimed at determining how diagnostic tests are used in the evaluation of pediatric syncope at a tertiary pediatric referral center and to report on the utility and the yield of these tests.Settings and Design Retrospective study conducted at a tertiary referral arrhythmolology serviceMethods and Material The clinical charts of 234 pediatric patients presenting with a primary complaint of syncope with an average age of 7.48 ± 3.82(3.5-16 years were reviewed by the investigators.Statistical analysis used Statistical Package of social science (SPSS version 9,0 was used for analysis of data.Results The commonest trigger for syncope in the study population was early following exercise (n=65 and the commonest prodrome was palpitation, noted in 25 patients. A murmur was present in 19 of our patients (8.3% while 10.7% (n=25 had abnormal ECGs. Of the 106 echocardiograms done, 14 (13.2% were abnormal. Only two of them were missed by ECG. All patients were offered ambulatory 24 hour ECG. One patient with sick sinus syndrome was diagnosed only with Holter.Conclusions Clues to the presence of cardiac syncope may include acute onset of syncope, frequent episodes, low difference between blood pressure readings in supine and erect positions (after standing for 2 minutes and most importantly an abnormal 12 lead ECG. Transthoracic echo and Holter monitoring have low yield in pediatric syncope.

Clinical Trials

Medline Plus

Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

Cost-effectiveness of monitoring free flaps.

Science.gov (United States)

Subramaniam, Shiva; Sharp, David; Jardim, Christopher; Batstone, Martin D

2016-06-01

Methods of free flap monitoring have become more sophisticated and expensive. This study aims to determine the cost of free flap monitoring and examine its cost effectiveness. We examined a group of patients who had had free flaps to the head and neck over a two-year period, and combined these results with costs obtained from business managers and staff. There were 132 free flaps with a success rate of 99%. The cost of monitoring was Aus $193/flap. Clinical monitoring during this time period cost Aus$25 476 and did not lead to the salvage of any free flaps. Cost equivalence is reached between monitoring and not monitoring only at a failure rate of 15.8%. This is to our knowledge the first study to calculate the cost of clinical monitoring of free flaps, and to examine its cost-effectiveness. Copyright © 2016 The British Association of Oral and Maxillofacial Surgeons. All rights reserved.

Chronic myelogenous leukemia: molecular monitoring in clinical practice

Directory of Open Access Journals (Sweden)

N. R. Ryabchikova

2013-01-01

Full Text Available Use of tyrosine kinase inhibitor imatinib has led to significant progress in chronic myeloid leukemia (CML treatment. To date, genetic monitoring is a mandatory attribute of therapy with tyrosine kinase inhibitors. The purpose of this study was to access the imatinib therapy efficacy in CML patients using complete molecular genetic monitoring by standard cytogenetics, realtime polymerase chain reaction and mutational analysis. Correlation between cytogenetic and molecular response was shown. Heterogeneity of molecular response in each patient group was revealed by expression of BCR-ABL. Kinase domain mutations were detected in 32 % of CML patients resistant to imatinib.

The potential of biosensor technology in clinical monitoring and experimental research

NARCIS (Netherlands)

Leegsma-Vogt, G; Rhemrev-Boom, MM; Tiessen, RG; Venema, K; Korf, J

2004-01-01

Glucose or lactate biosensors are very useful for monitoring metabolism. Continuous monitoring of glucose is for example very important in diabetic patients. The measurement of lactate, a marker for oxygen deficiency, is used in the intensive care unit to monitor the patients' condition. In our

Transcranial motor evoked potential monitoring outcome in the high-risk brain and spine surgeries: Correlation of clinical and neurophysiological data - An Indian perspective

Directory of Open Access Journals (Sweden)

Poornima Amit Shah

2013-01-01

Full Text Available Objective: The objective of this study is to assess the safety, feasibility and clinical value of transcranial motor evoked potential (MEP monitoring by electrical stimulation. Setting: Clinical neurophysiology department of tertiary reach hospital. Materials and Methods: MEP monitoring was attempted in 44 "high risk" patients. Intraoperative surgical, anesthesia and neurophysiological findings were documented prospectively. MEP monitoring results were correlated with motor outcome. Results: The success for reliable MEP recording from the lower limbs was 75%. Incidence of new permanent post-operative motor deficit was zero. Nearly, 76.5% of the cases (13 out of 17 cases who showed unobtainable and unstable MEP outcome had lesion location in the spine as compared with 23.5% (4 out of 17 cases that had lesion location in the brain. Chi-square test demonstrated a statistically significant difference between these two groups (P = 0.0020. Out of these 13 spine surgery cases, 8 (62% were operated for deformity. Seven out of 12 (60% patients less than 12 years of age had a poor MEP monitoring outcome suggesting that extremes of age and presence of a spine deformity may be associated with a lesser incidence of successful MEP monitoring. No complications related to the repetitive transcranial electrical stimulation for eliciting MEP were observed. Conclusion: MEP monitoring is safe. The protocol used in this study is simple, feasible for use and has a fairly high success rate form the lower limbs. Pediatric age group and spine lesions, particularly deformities have an adverse effect on stable MEP recording.

A Systematic Review of Wearable Patient Monitoring Systems - Current Challenges and Opportunities for Clinical Adoption.

Science.gov (United States)

Baig, Mirza Mansoor; GholamHosseini, Hamid; Moqeem, Aasia A; Mirza, Farhaan; Lindén, Maria

2017-07-01

The aim of this review is to investigate barriers and challenges of wearable patient monitoring (WPM) solutions adopted by clinicians in acute, as well as in community, care settings. Currently, healthcare providers are coping with ever-growing healthcare challenges including an ageing population, chronic diseases, the cost of hospitalization, and the risk of medical errors. WPM systems are a potential solution for addressing some of these challenges by enabling advanced sensors, wearable technology, and secure and effective communication platforms between the clinicians and patients. A total of 791 articles were screened and 20 were selected for this review. The most common publication venue was conference proceedings (13, 54%). This review only considered recent studies published between 2015 and 2017. The identified studies involved chronic conditions (6, 30%), rehabilitation (7, 35%), cardiovascular diseases (4, 20%), falls (2, 10%) and mental health (1, 5%). Most studies focussed on the system aspects of WPM solutions including advanced sensors, wireless data collection, communication platform and clinical usability based on a specific area or disease. The current studies are progressing with localized sensor-software integration to solve a specific use-case/health area using non-scalable and 'silo' solutions. There is further work required regarding interoperability and clinical acceptance challenges. The advancement of wearable technology and possibilities of using machine learning and artificial intelligence in healthcare is a concept that has been investigated by many studies. We believe future patient monitoring and medical treatments will build upon efficient and affordable solutions of wearable technology.

Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline.

Science.gov (United States)

Peters, Anne L; Ahmann, Andrew J; Battelino, Tadej; Evert, Alison; Hirsch, Irl B; Murad, M Hassan; Winter, William E; Wolpert, Howard

2016-11-01

To formulate clinical practice guidelines for the use of continuous glucose monitoring and continuous subcutaneous insulin infusion in adults with diabetes. The participants include an Endocrine Society-appointed Task Force of seven experts, a methodologist, and a medical writer. The American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology co-sponsored this guideline. The Task Force developed this evidence-based guideline using the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned one systematic review and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Continuous subcutaneous insulin infusion and continuous glucose monitoring have an important role in the treatment of diabetes. Data from randomized controlled trials are limited on the use of medical devices, but existing studies support the use of diabetes technology for a wide variety of indications. This guideline presents a review of the literature and practice recommendations for appropriate device use.

Structural and diffusion imaging versus clinical assessment to monitor amyotrophic lateral sclerosis

Directory of Open Access Journals (Sweden)

Arturo Cardenas-Blanco

2016-01-01

Full Text Available Amyotrophic lateral sclerosis is a progressive neurodegenerative disease that affects upper and lower motor neurons. Observational and intervention studies can be tracked using clinical measures such as the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R but for a complete understanding of disease progression, objective in vivo biomarkers of both central and peripheral motor pathway pathology are highly desirable. The aim of this study was to determine the utility of structural and diffusion imaging as central nervous system biomarkers compared to the standard clinical measure, ALSFRS-R, to track longitudinal evolution using three time-point measurements. N = 34 patients with ALS were scanned and clinically assessed three times at a mean of three month time intervals. The MRI biomarkers were structural T1-weighted volumes for cortical thickness measurement as well as deep grey matter volumetry, voxel-based morphometry and diffusion tensor imaging (DTI. Cortical thickness focused specifically on the precentral gyrus while quantitative DTI biomarkers focused on the corticospinal tracts. The evolution of imaging biomarkers and ALSFRS-R scores over time were analysed using a mixed effects model that accounted for the scanning interval as a fixed effect variable, and, the initial measurements and time from onset as random variables. The mixed effects model showed a significant decrease in the ALSFRS-R score, (p  0.5. In addition, deep grey matter volumetry and voxel-based morphometry also identified no significant changes. Furthermore, the availability of three time points was able to indicate that there was a linear progression in both clinical and fractional anisotropy measures adding to the validity of these results. The results indicate that DTI is clearly a superior imaging marker compared to atrophy for tracking the evolution of the disease and can act as a central nervous biomarker in longitudinal studies. It

Current concepts in blood glucose monitoring.

Science.gov (United States)

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

2013-12-01

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

Current concepts in blood glucose monitoring

Science.gov (United States)

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

2013-01-01

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

Current concepts in blood glucose monitoring

Directory of Open Access Journals (Sweden)

Kranti Shreesh Khadilkar

2013-01-01

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

Further contribution to the development of nuclear stethoscopic techniques

International Nuclear Information System (INIS)

Horvath, M.; Nemeth, L.; Kantor, E.; Kiss, J.; Bocsa, Z.; Sziberth, P.; Karman, M.

1991-01-01

After the introduction of radiocardiography (RCG) function analysis, the method has gradually been improved by applying scintillation probes, semiconductor detectors and computer evaluation. Miniature semiconductor detectors were fixed onto the chest, the detection efficiency and energy resolution was clarified to further improve the RCG technique. Various semiconductor devices were tested and compared. The RCG was combined with Holter monitoring and ECG. Photodiode RCG was extended to ergometric measurements. These new improvements were evaluated. (R.P.) 8 refs.; 8 figs

HEREDITARY INTRAVENTRICULAR CONDUCTION DISORDERS IN THE FAMILY FROM KRASNOYARSK

Directory of Open Access Journals (Sweden)

A. A. Chernova

2011-01-01

Full Text Available Pedigree of the family from Krasnoyarsk city with hereditary disorders of intracardiac conduction was studied. The diagnosis of each family member was verified by electrocardiography (ECG, echocardiography , bicycle ergometry , ECG Holter monitoring. The family 10-year follow-up showed familial aggregation of intracardiac conduction disorders in grandson, niece, son of the proband niece, ie, in the III-degree relatives. Family history of III-degree relatives with intracardiac conduction disorders and discordant pathology is identified.

A Psychological Factor Affecting a Cardiac Condition in a Psychotherapist

OpenAIRE

R Waxman; K Khorasani; A Lenny; S Bhalerao

2009-01-01

It has been established that intense emotions can affect the development and course of cardiac arrhythmias. This study sought to convey that a lack of expression of emotion can also have an effect on arrhythmias. A psychotherapist with Idiopathic Ventricular Fibrillation and an Implantable Cardioverter Defibrillator measured his rate of Premature Ventricular Contractions using a Holter monitor during three separate six-week periods and in three domains: A) work days vs. off days, B) a 27 hour...

Arrhythmia as a cardiac manifestation in MELAS syndrome.

Science.gov (United States)

Thomas, Tamara; Craigen, William J; Moore, Ryan; Czosek, Richard; Jefferies, John L

2015-09-01

A 44-year-old female with a diagnosis of mitochondrial myopathy, encephalopathy and stroke-like episodes (MELAS) syndrome had progressive left ventricular hypertrophy (LVH) on echocardiogram. A Holter monitor demonstrated episodes of non-sustained atrial tachycardia, a finding not been previously described in this population. This unique case of MELAS syndrome demonstrates the known associated cardiac manifestation of LVH and the new finding of atrial tachycardia which may represent the potential for subclinical arrhythmia in this population.

Evaluation of the environmental equivalent dose rate using area monitors for neutrons in clinical linear accelerators; Avaliacao da taxa de equivalente de dose ambiente utilizando monitores de area para neutrons em aceleradores lineares clinicos

Energy Technology Data Exchange (ETDEWEB)

Salgado, Ana Paula; Pereira, Walsan Wagner; Patrao, Karla C. de Souza; Fonseca, Evaldo S. da, E-mail: asalgado@ird.gov.b [Instituto de Radioprotecao e Dosimetria (IRD/CNEN-RJ), Rio de Janeiro, RJ (Brazil); Batista, Delano V.S. [Instituto Nacional do Cancer (INCa), Rio de Janeiro, RJ (Brazil)

2009-07-01

The Neutron Laboratory of the Radioprotection and Dosimetry Institute - IRD/CNEN, Rio de Janeiro, Brazil, initiated studies on the process of calibration of neutron area monitors and the results of the measurements performed at radiotherapy treatment rooms, containing clinical accelerators

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY 2018 POSITION STATEMENT ON INTEGRATION OF INSULIN PUMPS AND CONTINUOUS GLUCOSE MONITORING IN PATIENTS WITH DIABETES MELLITUS.

Science.gov (United States)

Grunberger, George; Handelsman, Yehuda; Bloomgarden, Zachary T; Fonseca, Vivian A; Garber, Alan J; Haas, Richard A; Roberts, Victor L; Umpierrez, Guillermo E

2018-03-01

This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there are no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician. AACE/ACE Task Force on Integration of Insulin Pumps and Continuous Glucose Monitoring in the Management of Patients With Diabetes Mellitus Chair George Grunberger, MD, FACP, FACE Task Force Members Yehuda Handelsman, MD, FACP, FNLA, MACE Zachary T. Bloomgarden, MD, MACE Vivian A. Fonseca, MD, FACE Alan J. Garber, MD, PhD, FACE Richard A. Haas, MD, FACE Victor L. Roberts, MD, MBA, FACP, FACE Guillermo E. Umpierrez, MD, CDE, FACP, FACE Abbreviations: AACE = American Association of Clinical Endocrinologists ACE = American College of Endocrinology A1C = glycated hemoglobin BGM = blood glucose monitoring CGM = continuous glucose monitoring CSII = continuous subcutaneous insulin infusion DM = diabetes mellitus FDA = Food & Drug Administration MDI = multiple daily injections T1DM = type 1 diabetes mellitus T2DM = type 2 diabetes mellitus SAP = sensor-augmented pump SMBG = self-monitoring of blood glucose STAR 3 = Sensor-Augmented Pump Therapy for A1C Reduction phase 3 trial.

Home-based mobile cardio-pulmonary rehabilitation consultant system.

Science.gov (United States)

Lee, Hsu-En; Wang, Wen-Chih; Lu, Shao-Wei; Wu, Bo-Yuan; Ko, Li-Wei

2011-01-01

Cardiovascular diseases are the most popular cause of death in the world recently. For postoperatives, cardiac rehabilitation is still asked to maintain at home (phase II) to improve cardiac function. However, only one third of outpatients do the exercise regularly, reflecting the difficulty for home-based healthcare: lacking of monitoring and motivation. Hence, a cardio-pulmonary rehabilitation system was proposed in this research to improve rehabilitation efficiency for better prognosis. The proposed system was built on mobile phone and receiving electrocardiograph (ECG) signal from a wireless ECG holter via Bluetooth connection. Apart from heart rate (HR) monitor, an ECG derived respiration (EDR) technique is also included to provide respiration rate (RR). Both HR and RR are the most important vital signs during exercise but only used one physiological signal recorder in this system. In clinical test, there were 15 subjects affording Bruce Task (treadmill) to simulate rehabilitation procedure. Correlation between this system and commercial product (Custo-Med) was up to 98% in HR and 81% in RR. Considering the prevention of sudden heart attack, an arrhythmia detection expert system and healthcare server at the backend were also integrated to this system for comprehensive cardio-pulmonary monitoring whenever and wherever doing the exercise.

Clinical trials using IFN-α as a vaccine adjuvant: new strategies for the molecular monitoring of the immune response

International Nuclear Information System (INIS)

Belardelli, F.; Arico, E.; Marincola, F.; Wang, E.

2009-01-01

The main general objective of this project was to define immunotherapy protocols based on the new concept of using IFN-a as and immune adjuvant, developing innovative methodologies suitable for predicting and monitoring the immunological and clinical responses. Specific aim of developing new micro arrays technologies particularly suitable for a molecular tracking and prediction of the response to IFN of cytokine-treated patients

Daily remote monitoring of implantable cardioverter-defibrillators

DEFF Research Database (Denmark)

Hindricks, Gerhard; Varma, Niraj; Kacet, Salem

2017-01-01

Aims: Remote monitoring of implantable cardioverter-defibrillators may improve clinical outcome. A recent meta-analysis of three randomized controlled trials (TRUST, ECOST, IN-TIME) using a specific remote monitoring system with daily transmissions [Biotronik Home Monitoring (HM)] demonstrated...

A thermal monitoring sheet with low influence from adjacent waterbolus for tissue surface thermometry during clinical hyperthermia.

Science.gov (United States)

Arunachalam, Kavitha; Maccarini, Paolo F; Stauffer, Paul R

2008-10-01

This paper presents a complete thermal analysis of a novel conformal surface thermometer design with directional sensitivity for real-time temperature monitoring during hyperthermia treatments of large superficial cancer. The thermal monitoring sheet (TMS) discussed in this paper consists of a 2-D array of fiberoptic sensors embedded between two layers of flexible, low-loss, and thermally conductive printed circuit board (PCB) film. Heat transfer across all interfaces from the tissue surface through multiple layers of insulating dielectrics surrounding the small buried temperature sensor and into an adjacent temperature-regulated water coupling bolus was studied using 3-D thermal simulation software. Theoretical analyses were carried out to identify the most effective differential TMS probe configuration possible with commercially available flexible PCB materials and to compare their thermal responses with omnidirectional probes commonly used in clinical hyperthermia. A TMS sensor design that employs 0.0508-mm Kapton MTB and 0.2032-mm Kapton HN flexible polyimide films is proposed for tissue surface thermometry with low influence from the adjacent waterbolus. Comparison of the thermal simulations with clinical probes indicates the new differential TMS probe design to outperform in terms of both transient response and steady-state accuracy in selectively reading the tissue surface temperature, while decreasing the overall thermal barrier of the probe between the coupling waterbolus and tissue surface.

Clinical Trials

Medline Plus

Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

Kilovoltage Intrafraction Monitoring for Prostate Intensity Modulated Arc Therapy: First Clinical Results

International Nuclear Information System (INIS)

Ng, Jin Aun; Booth, Jeremy T.; Poulsen, Per R.; Fledelius, Walther; Worm, Esben Schjødt; Eade, Thomas; Hegi, Fiona; Kneebone, Andrew; Kuncic, Zdenka; Keall, Paul J.

2012-01-01

Purpose: Most linear accelerators purchased today are equipped with a gantry-mounted kilovoltage X-ray imager which is typically used for patient imaging prior to therapy. A novel application of the X-ray system is kilovoltage intrafraction monitoring (KIM), in which the 3-dimensional (3D) tumor position is determined during treatment. In this paper, we report on the first use of KIM in a prospective clinical study of prostate cancer patients undergoing intensity modulated arc therapy (IMAT). Methods and Materials: Ten prostate cancer patients with implanted fiducial markers undergoing conventionally fractionated IMAT (RapidArc) were enrolled in an ethics-approved study of KIM. KIM involves acquiring kV images as the gantry rotates around the patient during treatment. Post-treatment, markers in these images were segmented to obtain 2D positions. From the 2D positions, a maximum likelihood estimation of a probability density function was used to obtain 3D prostate trajectories. The trajectories were analyzed to determine the motion type and the percentage of time the prostate was displaced ≥3, 5, 7, and 10 mm. Independent verification of KIM positional accuracy was performed using kV/MV triangulation. Results: KIM was performed for 268 fractions. Various prostate trajectories were observed (ie, continuous target drift, transient excursion, stable target position, persistent excursion, high-frequency excursions, and erratic behavior). For all patients, 3D displacements of ≥3, 5, 7, and 10 mm were observed 5.6%, 2.2%, 0.7% and 0.4% of the time, respectively. The average systematic accuracy of KIM was measured at 0.46 mm. Conclusions: KIM for prostate IMAT was successfully implemented clinically for the first time. Key advantages of this method are (1) submillimeter accuracy, (2) widespread applicability, and (3) a low barrier to clinical implementation. A disadvantage is that KIM delivers additional imaging dose to the patient.

Performance evaluation of enzyme immunoassay for voriconazole therapeutic drug monitoring with automated clinical chemistry analyzers

Directory of Open Access Journals (Sweden)

Yongbum Jeon

2017-08-01

Full Text Available Objective: Voriconazole is a triazole antifungal developed for the treatment of fungal infectious disease, and the clinical utility of its therapeutic drug monitoring has been evaluated. Recently, a new assay for analyzing the serum voriconazole concentration with an automated clinical chemistry analyzer was developed. We evaluated the performance of the new assay based on standardized protocols. Methods: The analytical performance of the assay was evaluated according to its precision, trueness by recovery, limit of quantitation, linearity, and correlation with results from liquid chromatography-tandem mass spectrometry (LC-MS/MS. The evaluation was performed with the same protocol on two different routine chemistry analyzers. All evaluations were performed according to CLSI Guidelines EP15, EP17, EP6, and EP9 [1–4]. Results: Coefficients of variation for within-run and between-day imprecision were 3.2–5.1% and 1.5–3.0%, respectively, on the two different analyzers for pooled serum samples. The recovery rates were in the range of 95.4–102.2%. The limit of blank was 0.0049 μg/mL, and the limit of detection of the samples was 0.0266–0.0376 μg/mL. The percent recovery at three LoQ levels were 67.9–74.6% for 0.50 μg/mL, 75.5–80.2% for 0.60 μg/mL, and 89.9–96.6% for 0.70 μg/mL. A linear relationship was demonstrated between 0.5 μg/mL and 16.0 μg/mL (R2=0.9995–0.9998. The assay correlated well with LC-MS/MS results (R2=0.9739–0.9828. Conclusions: The assay showed acceptable precision, trueness, linearity, and limit of quantification, and correlated well with LC-MS/MS. Therefore, its analytical performance is satisfactory for monitoring the drug concentration of voriconazole. Keywords: Voriconazole, Antifungal agents, Therapeutic drug monitoring

Monitoring Compliance to Promote Quality Assurance: Development of a Mental Health Clinical Chart Audit Tool in Belize, 2013.

Science.gov (United States)

Winer, Rachel A; Bennett, Eleanor; Murillo, Illouise; Schuetz-Mueller, Jan; Katz, Craig L

2015-09-01

Belize trained psychiatric nurse practitioners (PNPs) in the early 1990s to provide mental health services throughout the country. Despite overwhelming success, the program is limited by lack of monitoring, evaluation, and surveillance. To promote quality assurance, we developed a chart audit tool to monitor mental healthcare delivery compliance for initial psychiatric assessment notes completed by PNPs. After reviewing the Belize Health Information System electronic medical record system, we developed a clinical audit tool to capture 20 essential components for initial assessment clinical notes. The audit tool was then piloted for initial assessment notes completed during July through September of 2013. One hundred and thirty-four initial psychiatric interviews were audited. The average chart score among all PNPs was 9.57, ranging from 3 to 15. Twenty-three charts-or 17.2%-had a score of 14 or higher and met a 70% compliance benchmark goal. Among indicators most frequently omitted included labs ordered and named (15.7%) and psychiatric diagnosis (21.6%). Explicit statement of medications initiated with dose and frequency occurred in 47.0% of charts. Our findings provide direction for training and improvement, such as emphasizing the importance of naming labs ordered, medications and doses prescribed, and psychiatric diagnoses in initial assessment clinical notes. We hope this initial assessment helps enhance mental health delivery compliance by prompting creation of BHIS templates, development of audits tools for revisit follow-up visits, and establishment of corrective actions for low-scoring practitioners. These efforts may serve as a model for implementing quality assurance programming in other low resource settings.

A clinical decision-making mechanism for context-aware and patient-specific remote monitoring systems using the correlations of multiple vital signs.

Science.gov (United States)

Forkan, Abdur Rahim Mohammad; Khalil, Ibrahim

2017-02-01

In home-based context-aware monitoring patient's real-time data of multiple vital signs (e.g. heart rate, blood pressure) are continuously generated from wearable sensors. The changes in such vital parameters are highly correlated. They are also patient-centric and can be either recurrent or can fluctuate. The objective of this study is to develop an intelligent method for personalized monitoring and clinical decision support through early estimation of patient-specific vital sign values, and prediction of anomalies using the interrelation among multiple vital signs. In this paper, multi-label classification algorithms are applied in classifier design to forecast these values and related abnormalities. We proposed a completely new approach of patient-specific vital sign prediction system using their correlations. The developed technique can guide healthcare professionals to make accurate clinical decisions. Moreover, our model can support many patients with various clinical conditions concurrently by utilizing the power of cloud computing technology. The developed method also reduces the rate of false predictions in remote monitoring centres. In the experimental settings, the statistical features and correlations of six vital signs are formulated as multi-label classification problem. Eight multi-label classification algorithms along with three fundamental machine learning algorithms are used and tested on a public dataset of 85 patients. Different multi-label classification evaluation measures such as Hamming score, F1-micro average, and accuracy are used for interpreting the prediction performance of patient-specific situation classifications. We achieved 90-95% Hamming score values across 24 classifier combinations for 85 different patients used in our experiment. The results are compared with single-label classifiers and without considering the correlations among the vitals. The comparisons show that multi-label method is the best technique for this problem

Clinical monitoring of tooth wear progression in patients over a period of one year using CAD/CAM

OpenAIRE

Ahmed, Khaled E.; Whitters, John; Ju, Xiangyang; Pierce, S. Gareth; MacLeod, Charles N.; Murray, Colin A.

2017-01-01

Purpose: The aim of this study was to clinically monitor the progression of tooth wear over a period of 1 year in a cohort of referred tooth wear patients through the use of a computer-aided design/ computer-assisted manufacture (CAD/CAM) scanner and a standardized scanning/assessment methodology. Materials and Methods: Polyether impressions were made of 11 participants (130 teeth) at baseline and at 1 year. Impressions were poured in type IV dental stone and the anterior teeth were 3D scanne...

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

Science.gov (United States)

van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

2017-01-01

This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

Comparative study of two modes of gastroesophageal reflux measuring: conventional esophageal pH monitoring and wireless pH monitoring

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Rimon Sobhi Azzam

2012-06-01

Full Text Available CONTEXT: Esophageal pH monitoring is considered to be the gold standard for the diagnosis of gastroesophageal acid reflux. However, this method is very troublesome and considerably limits the patient's routine activities. Wireless pH monitoring was developed to avoid these restrictions. OBJECTIVE: To compare the first 24 hours of the conventional and wireless pH monitoring, positioned 3 cm above the lower esophageal sphincter, in relation to: the occurrence of relevant technical failures, the ability to detect reflux and the ability to correlate the clinical symptoms to reflux. METHODS: Twenty-five patients referred for esophageal pH monitoring and with typical symptoms of gastroesophageal reflux disease were studied prospectively, underwent clinical interview, endoscopy, esophageal manometry and were submitted, with a simultaneous initial period, to 24-hour catheter pH monitoring and 48-hour wireless pH monitoring. RESULTS: Early capsule detachment occurred in one (4% case and there were no technical failures with the catheter pH monitoring (P = 0.463. Percentages of reflux time (total, upright and supine were higher with the wireless pH monitoring (P < 0.05. Pathological gastroesophageal reflux occurred in 16 (64% patients submitted to catheter and in 19 (76% to the capsule (P = 0.355. The symptom index was positive in 12 (48% patients with catheter pH monitoring and in 13 (52% with wireless pH monitoring (P = 0.777. CONCLUSIONS: 1 No significant differences were reported between the two methods of pH monitoring (capsule vs catheter, in regard to relevant technical failures; 2 Wireless pH monitoring detected higher percentages of reflux time than the conventional pH-metry; 3 The two methods of pH monitoring were comparable in diagnosis of pathological gastroesophageal reflux and comparable in correlating the clinical symptoms with the gastroesophageal reflux.

Heart rate variability in healthy population

International Nuclear Information System (INIS)

Alamgir, M.; Hussain, M.M.

2010-01-01

Background: Heart rate variability has been considered as an indicator of autonomic status. Little work has been done on heart rate variability in normal healthy volunteers. We aimed at evolving the reference values of heart rate variability in our healthy population. Methods: Twenty-four hour holter monitoring of 37 healthy individuals was done using Holter ECG recorder 'Life card CF' from 'Reynolds Medical'. Heart rate variability in both time and frequency domains was analysed with 'Reynolds Medical Pathfinder Digital/700'. Results: The heart rate variability in normal healthy volunteers of our population was found in time domain using standard deviation of R-R intervals (SDNN), standard deviation of average NN intervals (SDANN), and Square root of the mean squared differences of successive NN intervals (RMSSD). Variation in heart rate variability indices was observed between local and foreign volunteers and RMSSD was found significantly increased (p<0.05) in local population. Conclusions: The values of heart rate variability (RMSSD) in healthy Pakistani volunteers were found increased compared to the foreign data reflecting parasympathetic dominance in our population. (author)

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

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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, Psmartphone (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, Psmartphone (beta=-.17, Psmartphone measurements, but not all smartphone measures predicted the occurrence of

Quantitative Clinical Imaging Methods for Monitoring Intratumoral Evolution.

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Kim, Joo Yeun; Gatenby, Robert A

2017-01-01

Solid tumors are multiscale, open, complex, dynamic systems: complex because they have many interacting components, dynamic because both the components and their interactions can change with time, and open because the tumor freely communicates with surrounding and even distant host tissue. Thus, it is not surprising that striking intratumoral variations are commonly observed in clinical imaging such as MRI and CT and that several recent studies found striking regional variations in the molecular properties of cancer cells from the same tumor. Interestingly, this spatial heterogeneity in molecular properties of tumor cells is typically ascribed to branching clonal evolution due to accumulating mutations while macroscopic variations observed in, for example, clinical MRI scans are usually viewed as functions of blood flow. The clinical significance of spatial heterogeneity has not been fully determined but there is a general consensus that the varying intratumoral landscape along with patient factors such as age, morbidity and lifestyle, contributes significantly to the often unpredictable response of individual patients within a disease cohort treated with the same standard-of-care therapy.Here we investigate the potential link between macroscopic tumor heterogeneity observed by clinical imaging and spatial variations in the observed molecular properties of cancer cells. We build on techniques developed in landscape ecology to link regional variations in the distribution of species with local environmental conditions that define their habitat. That is, we view each region of the tumor as a local ecosystem consisting of environmental conditions such as access to nutrients, oxygen, and means of waste clearance related to blood flow and the local population of tumor cells that both adapt to these conditions and, to some extent, change them through, for example, production of angiogenic factors. Furthermore, interactions among neighboring habitats can produce broader

Implantable sensors for heart failure monitoring

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P. Shasha Liu

2013-12-01

Implantable sensors in the CRT device offer a unique opportunity for continuous monitoring of a patient's clinical HF status by measuring cardiac rhythm, intracardiac pressures, cardiac events, and physical activity, as well as detecting any device malfunction. Detecting early signs of a deteriorating clinical condition allows prompt preemptive medical intervention to optimize HF management. As a result, not only healthcare professionals will benefit from a reduction in hospitalizations and routine in-office follow-ups, but also patients will benefit from efficient management of their HF. This review highlights the latest available device-based remote monitoring systems and the most up-to-date evidence for the use of remote monitoring in CRT.

Pharmacist-led implementation of a vancomycin guideline across medical and surgical units: impact on clinical behavior and therapeutic drug monitoring outcomes

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Phillips CJ

2015-10-01

Full Text Available Cameron J Phillips,1–3 David L Gordon3,4 1Division of Pharmacy, SA Pharmacy, Flinders Medical Centre, Bedford Park, 2School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, 3Department of Microbiology and Infectious Diseases, School of Medicine, Flinders University, Adelaide, 4Department of Microbiology and Infectious Diseases, SA Pathology, Flinders Medical Centre, Bedford Park, SA, Australia Background: Vancomycin is the antibiotic of choice for the treatment of serious infections such as methicillin-resistant Staphylococcus aureus (MRSA. Inappropriate prescribing of vancomycin can lead to therapeutic failure, antibiotic resistance, and drug toxicity. Objective: To examine the effectiveness of pharmacist-led implementation of a clinical practice guideline for vancomycin dosing and monitoring in a teaching hospital. Methods: An observational pre–post study design was undertaken to evaluate the implementation of the vancomycin guideline. The implementation strategy principally involved education, clinical vignettes, and provision of pocket guidelines to accompany release of the guideline to the hospital Intranet. The target cohort for clinical behavioral change was junior medical officers, as they perform the majority of prescribing and monitoring of vancomycin in hospitals. Assessment measures were recorded for vancomycin prescribing, therapeutic drug monitoring, and patient outcomes. Results: Ninety-nine patients, 53 pre- and 46 post-implementation, were included in the study. Prescribing of a loading dose increased from 9% to 28% (P=0.02, and guideline adherence to starting maintenance dosing increased from 53% to 63% (P=0.32. Dose adjustment by doctors when blood concentrations were outside target increased from 53% to 71% (P=0.12, and correct timing of initial concentration measurement increased from 43% to 57% (P=0.23. Appropriately timed trough concentrations improved from 73% to 81% (P=0.08. Pre-dose (trough

Utility of heart rate turbulence and T-Wave alternans to assess risk for Re-admission and cardiac death in hospitalized heart failure patients.

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Yamada, Shinya; Yoshihisa, Akiomi; Sato, Yu; Sato, Takamasa; Kamioka, Masashi; Kaneshiro, Takashi; Oikawa, Masayoshi; Kobayashi, Atsushi; Suzuki, Hitoshi; Ishida, Takafumi; Takeishi, Yasuchika

2018-05-18

Heart failure (HF) patients have a higher risk of recurrent HF and cardiac death, and electrical remodeling is considered to be an important factor for HF progression. The present study aimed to validate the utility of electrocardiogram and Holter monitoring for the risk stratification of HF patients. Our study comprised 215 patients (144 males, mean age 62 years) who had been hospitalized due to acute decompensated HF. Electrocardiogram (QRS duration and QTc interval) and 24-hour Holter monitoring (heart rate variability, heart rate turbulence and T-wave alternans [TWA]) were performed in stable condition before discharge. The clinical characteristics and outcomes were then investigated. During a median follow-up period of 2.7 years, there were 83 (38.6%) cardiac events (re-hospitalization due to worsening HF [n = 51] or cardiac death [n = 32]). The patients with cardiac events had a lower turbulence slope (TS) and higher TWA compared to those without cardiac events (TS, 3.0±5.5 ms/RR vs. 5.3±5.6 ms/RR, P = 0.001; TWA, 66.1±19.6 μV vs. 54.7±15.1 μV, P < 0.001). Univariable analysis showed that TS, TWA, QRS duration, and QTc interval were associated with cardiac events (P = 0.004, P < 0.001, P = 0.037 and P = 0.024, respectively), while the multivariable analysis after the adjustment of multiple confounders showed that TS and TWA were independent predictive factors of cardiac events with a hazard ratio of 0.936 and 1.015 (95% confidence interval [CI]: 0.860-0.974, P = 0.006; and 95% CI: 1.003-1.027, p = 0.016), respectively. The measurement of TS and TWA is useful for assessing risk for re-hospitalization and cardiac death in HF patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Electrical impedance tomography: A new monitoring of regional distribution of lung ventilation (principle of work and clinical application

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Vuković Rade

2017-01-01

Full Text Available Soon after it's discovery in the 1980s, the Electrical Impedance Tomography (EIT, became the topic of interest, primarily regarding its applicability in different diagnostic procedures and monitoring. EIT is a non-invasive procedure, with no additional harmful radiation, which can be used continuously to monitor regional distribution of ventilation, in contrast to the computerized tomography and other diagnostic procedures that have a single image of the respiratory system and its function. Additionally, EIT allows continuous visualization of the lung function at the patient bedside, with an immediate assessment of the respiratory therapeutic maneuvers effects. The results obtained by EIT are complementary to other pulmonary diagnostic procedures, primarily from radiology. In general, EIT provides additional information to the conventional pulmonary monitoring. Crucial to the implementation of lung protective ventilation concept is to determine the ideal alveolar recruitment, which maintains open and functional alveoli during ventilation, meanwhile carrying a minimal risk for lung injury with excessive breathing volume ('over distension'. EIT may be considered as a good guide for optimal adjustment of respiratory support parameters and selection of the ventilation mode. Nowadays, the technical and technological development, hardware and software improvements and experimental validation of the results in animals and volunteers, have enabled practical clinical use of EIT, a useful monitor of regional distribution of lungs ventilation.

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

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

2013-04-01

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

Assuring Quality Control of Clinical Education in Multiple Clinical Affiliates.

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Davis, Judith A.

A plan was developed to assure equivalency of clinical education among the medical laboratory technician (MLT) programs affiliated with Sandhills Community College. The plan was designed by faculty to monitor the quality of clinical courses offered by the clinical affiliates. The major strategies were to develop competencies, slide/tape modules, a…

Implantable Nanosensors: Towards Continuous Physiologic Monitoring

OpenAIRE

Ruckh, Timothy T.; Clark', Heather A.

2013-01-01

Continuous physiologic monitoring would add greatly to both home and clinical medical treatment for chronic conditions. Implantable nanosensors are a promising platform for designing continuous monitoring systems. This feature reviews design considerations and current approaches towards such devices.

CONTINUOUS GLUCOSE MONITORING: A CONSENSUS CONFERENCE OF THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY.

Science.gov (United States)

Fonseca, Vivian A; Grunberger, George; Anhalt, Henry; Bailey, Timothy S; Blevins, Thomas; Garg, Satish K; Handelsman, Yehuda; Hirsch, Irl B; Orzeck, Eric A; Roberts, Victor Lawrence; Tamborlane, William

2016-08-01

Barriers to continuous glucose monitoring (CGM) use continue to hamper adoption of this valuable technology for the management of diabetes. The American Association of Clinical Endocrinologists and the American College of Endocrinology convened a public consensus conference February 20, 2016, to review available CGM data and propose strategies for expanding CGM access. Conference participants agreed that evidence supports the benefits of CGM in type 1 diabetes and that these benefits are likely to apply whenever intensive insulin therapy is used, regardless of diabetes type. CGM is likely to reduce healthcare resource utilization for acute and chronic complications, although real-world analyses are needed to confirm potential cost savings and quality of life improvements. Ongoing technological advances have improved CGM accuracy and usability, but more innovations in human factors, data delivery, reporting, and interpretation are needed to foster expanded use. The development of a standardized data report using similar metrics across all devices would facilitate clinician and patient understanding and utilization of CGM. Expanded CGM coverage by government and private payers is an urgent need. CGM improves glycemic control, reduces hypoglycemia, and may reduce overall costs of diabetes management. Expanding CGM coverage and utilization is likely to improve the health outcomes of people with diabetes. A1C = glycated hemoglobin AACE = American Association of Clinical Endocrinologists ACE = American College of Endocrinology ASPIRE = Automation to Simulate Pancreatic Insulin Response CGM = continuous glucose monitoring HRQOL = health-related quality of life ICER = incremental cost-effectiveness ratio JDRF = Juvenile Diabetes Research Foundation MARD = mean absolute relative difference MDI = multiple daily injections QALY = quality-adjusted life years RCT = randomized, controlled trial SAP = sensor-augmented pump SMBG = self-monitoring of blood glucose STAR = Sensor

Performance evaluation of enzyme immunoassay for voriconazole therapeutic drug monitoring with automated clinical chemistry analyzers.

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Jeon, Yongbum; Han, Minje; Han, Eun Young; Lee, Kyunghoon; Song, Junghan; Song, Sang Hoon

2017-08-01

Voriconazole is a triazole antifungal developed for the treatment of fungal infectious disease, and the clinical utility of its therapeutic drug monitoring has been evaluated. Recently, a new assay for analyzing the serum voriconazole concentration with an automated clinical chemistry analyzer was developed. We evaluated the performance of the new assay based on standardized protocols. The analytical performance of the assay was evaluated according to its precision, trueness by recovery, limit of quantitation, linearity, and correlation with results from liquid chromatography-tandem mass spectrometry (LC-MS/MS). The evaluation was performed with the same protocol on two different routine chemistry analyzers. All evaluations were performed according to CLSI Guidelines EP15, EP17, EP6, and EP9 [1-4]. Coefficients of variation for within-run and between-day imprecision were 3.2-5.1% and 1.5-3.0%, respectively, on the two different analyzers for pooled serum samples. The recovery rates were in the range of 95.4-102.2%. The limit of blank was 0.0049 μg/mL, and the limit of detection of the samples was 0.0266-0.0376 μg/mL. The percent recovery at three LoQ levels were 67.9-74.6% for 0.50 μg/mL, 75.5-80.2% for 0.60 μg/mL, and 89.9-96.6% for 0.70 μg/mL. A linear relationship was demonstrated between 0.5 μg/mL and 16.0 μg/mL ( R 2 =0.9995-0.9998). The assay correlated well with LC-MS/MS results ( R 2 =0.9739-0.9828). The assay showed acceptable precision, trueness, linearity, and limit of quantification, and correlated well with LC-MS/MS. Therefore, its analytical performance is satisfactory for monitoring the drug concentration of voriconazole.

Ability of a 5-minute electrocardiography (ECG) for predicting arrhythmias in Doberman Pinschers with cardiomyopathy in comparison with a 24-hour ambulatory ECG.

Science.gov (United States)

Wess, G; Schulze, A; Geraghty, N; Hartmann, K

2010-01-01

Ventricular premature contractions (VPCs) are common in the occult stage of cardiomyopathy in Doberman Pinschers. Although the gold standard for detecting arrhythmia is the 24-hour ambulatory electrocardiography (ECG) (Holter), this method is more expensive, time-consuming and often not as readily available as common ECG. Comparison of 5-minute ECGs with Holter examinations. Eight hundred and seventy-five 5-minute ECGs and Holter examinations of 431 Doberman Pinschers. Each examination included a 5-minute ECG and Holter examination. A cut-off value of > 100 VPCs/24 hours using Holter was considered diagnostic for the presence of cardiomyopathy. Statistical evaluation included calculation of sensitivity, specificity, positive predictive value, and negative predictive value. Holter examinations revealed > 100 VPCs/24 hours in 204/875 examinations. At least 1 VPC during a 5-minute ECG was detected in 131 (64.2%) of these 204 examinations. No VPCs were found in the 5-minute ECG in 73 (35.8%) examinations of affected Doberman Pinschers. A 5-minute ECG with at least 1 VPC as cut-off had a sensitivity of 64.2%, a specificity of 96.7%, a positive predictive value of 85.6% and a negative predictive value of 89.9% for the presence of > 100 VPCs/24 hours. A 5-minute ECG is a rather insensitive method for detecting arrhythmias in Doberman Pinschers. However, the occurrence of at least 1 VPC in 5 minutes strongly warrants further examination of the dog, because specificity (96.7%) and positive predictive value (85.6%) are high and could suggest occult cardiomyopathy.

Satisfaction Survey on Information Technology-Based Glucose Monitoring System Targeting Diabetes Mellitus in Private Local Clinics in Korea

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Hun-Sung Kim

2017-06-01

Full Text Available BackgroundPrivate local clinics in Korea have little experience with information technology (IT-based glucose monitoring (ITGM. Our aim is to examine user satisfaction and the possibility of using ITGM service practically.MethodsPatients sent their blood glucose levels to physicians in local clinics. The physicians reviewed the blood glucose values online and provided personal consultations through text messaging or phone calls. Thereafter, a satisfaction survey on the ITGM service, the modified Morisky scale, and patient assessment of chronic illness care were administered.ResultsOne hundred and seventy patients from seven private local clinics used the ITGM. Overall satisfaction, including that about the ITGM service, the device, and its usefulness, was rated higher than “mostly satisfied” (score 4.2±0.8 out of 5.0 and even higher among the elderly. Satisfaction was positively associated with age, especially in those older than 60 years. The main reason for intent for future use of the service was the time/place flexibility. Highly motivated patients tended to answer positively regarding information satisfaction (P=0.0377.ConclusionOur study is the first to investigate ITGM satisfaction in private local clinics. The feasibility of users utilizing ITGM should be clarified, and future clinical research on the service's clinical effects and cost-benefit analysis is needed.

Perioperative Rosuvastatin in Cardiac Surgery.

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Zheng, Zhe; Jayaram, Raja; Jiang, Lixin; Emberson, Jonathan; Zhao, Yan; Li, Qi; Du, Juan; Guarguagli, Silvia; Hill, Michael; Chen, Zhengming; Collins, Rory; Casadei, Barbara

2016-05-05

Complications after cardiac surgery are common and lead to substantial increases in morbidity and mortality. Meta-analyses of small randomized trials have suggested that perioperative statin therapy can prevent some of these complications. We randomly assigned 1922 patients in sinus rhythm who were scheduled for elective cardiac surgery to receive perioperative rosuvastatin (at a dose of 20 mg daily) or placebo. The primary outcomes were postoperative atrial fibrillation within 5 days after surgery, as assessed by Holter electrocardiographic monitoring, and myocardial injury within 120 hours after surgery, as assessed by serial measurements of the cardiac troponin I concentration. Secondary outcomes included major in-hospital adverse events, duration of stay in the hospital and intensive care unit, left ventricular and renal function, and blood biomarkers. The concentrations of low-density lipoprotein cholesterol and C-reactive protein after surgery were lower in patients assigned to rosuvastatin than in those assigned to placebo (PSTICS ClinicalTrials.gov number, NCT01573143.).

[Non-invasive exploration methods of supraventricular arrhythmia in current practice].

Science.gov (United States)

Fauchier, J P; Fauchier, L; Babuty, D; Sirinelli, A; Cosnay, P

1993-06-15

In patients with supraventricular rhythm disorders ambulatory electro-cardiographic recording (Holter system) is an indispensable examination as it detects attacks that pass unrecorded by conventional ECG, being asymptomatic, too brief or too rare. It confirms the diagnosis, defines the factors triggering the attacks, detects the association of rhythm and conduction disorders, guides the treatment and monitors its effectiveness. Sequential ambulatory recording lends itself particularly well to this last objective. Biochemical examinations explain the cause of certain relapses (potassium depletion, high alcohol blood level) or detect the origin, clinically more or less obvious, of these disorders of rhythm (essays of thyroid hormones). Measuring blood levels of therapeutic drugs makes the handling of these various drugs safer. Finally, echocardiography detects an underlying heart disease, evaluates the size of the left atrium (a factor of relapse when it is dilated and of embolism when it harbours thrombi) and assesses the left ventricular function before administration of antiarrhythmics which, to varying extents, are all negative inotropic drugs.

Cryptogenic embolic stroke in a girl with a trisomy 21 mosaic.

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Stöllberger, Claudia; Weiss, Simone; Zlabinger, Gerhard; Finsterer, Josef

2012-06-01

Stroke in trisomy 21 may be due to cardioembolism, atherosclerosis, vasculitis, moyamoya disease, sinus venous thrombosis, internal carotid hypoplasia or infections like endocarditis with septic emboli, meningitis or brain abscess. In rare cases, however, stroke etiology remains unexplained. We present a 19 year old Caucasian girl with trisomy 21 with a 47XX+21 karyotype who suffered at age 11 years from a transient ischemic attack with left hemiparesis, and at age 17 years from an ischemic stroke in the territory of the right cerebral medial artery. She suffered from arterial hypertension, obesity and hypercholesterolemia. Since blood coagulation studies, immunologic parameters, blood cultures, 24-h Holter monitoring, transthoracic and transesophageal echocardiography, magnetic resonance angiography of the extra- and intracranial vessels, thoracic and abdominal aorta and renal arteries did not provide any explanation for the stroke, implantation of a loop recorder is considered in order to detect episodes of clinically silent atrial fibrillation.

Clinical validation of a body-fixed 3D accelerometer and algorithm for activity monitoring in orthopaedic patients

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Matthijs Lipperts

2017-10-01

Conclusion: Activity monitoring of orthopaedic patients by counting and timing a large set of relevant daily life events is feasible in a user- and patient-friendly way and at high clinical validity using a generic three-dimensional accelerometer and algorithms based on empirical and physical methods. The algorithms performed well for healthy individuals as well as patients recovering after total joint replacement in a challenging validation set-up. With such a simple and transparent method real-life activity parameters can be collected in orthopaedic practice for diagnostics, treatments, outcome assessment, or biofeedback.

Review of the clinical applications and technological advances of circulating tumor DNA in cancer monitoring.

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Chang, Yi; Tolani, Bhairavi; Nie, Xiuhong; Zhi, Xiuyi; Hu, Mu; He, Biao

2017-01-01

Circulating cell-free DNA (cfDNA) released by tumor cells, termed ctDNA, closely reflects the heterogeneity of primary cancers and their metastases. As a noninvasive, real-time monitoring biomarker, ctDNA is a promising tool for detecting driver gene mutations, assessing tumor burden and acquired resistance, and early diagnosis. However, isolation and enrichment of cfDNA is a big challenge due to the high degree of DNA fragmentation and its relatively low abundance in the bloodstream. This review aims to provide insights into the recent technological advances in acquisition of optimal quality cfDNA, the use of preservatives, isolation methods, processing timelines, and detection techniques. It also describes clinical applications of ctDNA in cancer patient management.

STRUCTURAL AND FUNCTIONAL CHANGES EVALUATED BY ECHOCARDIOGRAPHY IN PATIENTS WITH SYSTEMIC SCLEROSIS AND HEART RATE VARIABILITY

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E. O. Saad

2017-01-01

Full Text Available Objective: to estimate heart rate variability (HRV in patients with systemic sclerosis (SS and to investigate their relationship to echocardiographic structural and functional changes in the heart.Subjects and methods. The investigation enrolled 125 patients with SS and 50 gender- and age-matched apparently healthy individuals who made up a control group. In addition to clinical examinations, 73 patients underwent HRV assessment from 24-hour Holter electrocardiogram (ECG monitoring results and 121 patients had echocardiography (EchoCG. 24-hour Holter ECG monitoring was carried out in all control individuals.Results and discussion. Examination of the main parameters of time-domain HRV in patients with SS revealed a significant decline in all temporal and spectral indices, except for the mean R–R interval duration (meanNN, as compared with the control group. EchoCG detected a variety of changes, primarily the induration and calcification of aortic and mitral valves in most patients. Left ventricular diastolic dysfunction was encountered in almost half of the patients with SS. Eight patients had a lower left ventricular ejection fraction (LVEF, which was <55%. Studying the association of HRV values with separate EchoCG parameters revealed significant inverse correlations of the mean standard deviation of R–R intervals in 5-minute recording segments during 24 hours with the thickness of the interventricular septum (r = -0.18; p < 0.05 and with the induration of the aortic valve (r = -0.18; p < 0.05; the square root mean squared of successive differences (RMSSD, ms for R–R intervals and the percentage of adjacent R–R intervals that varied by more than 50 ms (pNN50 correlated with the induration of the aortic valve (r = -0.23; p<0.05 and r = -0.25; p < 0.05, respectively, with the presence of pericarditis (r = -0.24; p < 0.05 and r = -0,27; p < 0.05, respectively, and with the level of pulmonary artery systolic pressure (r = -0

Cardiac monitoring during adjuvant trastuzumab therapy: Guideline adherence in clinical practice

NARCIS (Netherlands)

Visser, Annemiek; van de Ven, Eline M. W.; Ruczynski, Larissa I. A.; Blaisse, Reinoud J. B.; van Halteren, Henk K.; Aben, Katja; van Laarhoven, Hanneke W. M.

2016-01-01

Cardiotoxicity is an important adverse effect of adjuvant breast cancer treatment with trastuzumab and three monthly left ventricular ejection fraction (LVEF) monitoring is considered mandatory. The purpose of this study was to gain insight into LVEF monitoring during adjuvant trastuzumab treatment

Exposure assessment and heart rate variability monitoring in workers handling titanium dioxide particles: a pilot study

Energy Technology Data Exchange (ETDEWEB)

Ichihara, Sahoko [Mie University, Graduate School of Regional Innovation Studies (Japan); Li, Weihua [WHO Collaborating Centre for Research in Human Reproduction, Shanghai Institute of Planned Parenthood Research (China); Omura, Seiichi [Tokyo Institute of Technology (Japan); Fujitani, Yuji [National Institute for Environmental Studies (Japan); Liu, Ying; Wang, Qiangyi [WHO Collaborating Centre for Research in Human Reproduction, Shanghai Institute of Planned Parenthood Research (China); Hiraku, Yusuke [Mie University Graduate School of Medicine, Department of Environmental and Molecular Medicine (Japan); Hisanaga, Naomi [Aichi Gakusen University, Faculty of Human Science and Design (Japan); Wakai, Kenji [Nagoya University Graduate School of Medicine, Department of Preventive Medicine (Japan); Ding, Xuncheng [WHO Collaborating Centre for Research in Human Reproduction, Shanghai Institute of Planned Parenthood Research (China); Kobayashi, Takahiro, E-mail: takakoba@airies.or.jp [Association for International Research Initiatives for Environmental Studies (Japan); Ichihara, Gaku, E-mail: gak@rs.tus.ac.jp [Tokyo University of Science, Department of Occupational and Environmental Health, Faculty of Pharmaceutical Sciences (Japan)

2016-03-15

Titanium dioxide (TiO{sub 2}) particles are used for surface coating and in a variety of products such as inks, fibers, food, and cosmetics. The present study investigated possible respiratory and cardiovascular effects of TiO{sub 2} particles in workers exposed to this particle at high concentration in a factory in China. The diameter of particles collected on filters was measured by scanning electron microscopy. Real-time size-dependent particle number concentration was monitored in the nostrils of four workers using condensation particle counter and optical particle counter. Electrocardiogram was recorded using Holter monitors for the same four workers to record heart rate variability. Sixteen workers underwent assessment of the respiratory and cardiovascular systems. Mass-based individual exposure levels were also measured with personal cascade impactors. The primary particle diameter ranged from 46 to 562 nm. Analysis of covariance of the pooled data of the four workers showed that number of particles with a diameter <300 nm was associated positively with total number of N–N and negatively with total number of increase or decrease in successive RR intervals greater than 50 ms (RR50+/−) or percentage of RR 50+/− that were parameters of parasympathetic function. The total mass concentration was 9.58–30.8 mg/m{sup 3} during work, but significantly less before work (0.36 mg/m{sup 3}). The clear abnormality in respiratory function was not observed in sixteen workers who had worked for 10 months to 13 years in the factory. The study showed that exposure to particles with a diameter <300 nm might affect HRV in workers handling TiO{sub 2} particles. The results highlight the need to investigate the possible impact of exposure to nano-scaled particles on the autonomic nervous system.

Wearable sensors for human health monitoring

Science.gov (United States)

Asada, H. Harry; Reisner, Andrew

2006-03-01

Wearable sensors for continuous monitoring of vital signs for extended periods of weeks or months are expected to revolutionize healthcare services in the home and workplace as well as in hospitals and nursing homes. This invited paper describes recent research progress in wearable health monitoring technology and its clinical applications, with emphasis on blood pressure and circulatory monitoring. First, a finger ring-type wearable blood pressure sensor based on photo plethysmogram is presented. Technical issues, including motion artifact reduction, power saving, and wearability enhancement, will be addressed. Second, sensor fusion and sensor networking for integrating multiple sensors with diverse modalities will be discussed for comprehensive monitoring and diagnosis of health status. Unlike traditional snap-shot measurements, continuous monitoring with wearable sensors opens up the possibility to treat the physiological system as a dynamical process. This allows us to apply powerful system dynamics and control methodologies, such as adaptive filtering, single- and multi-channel system identification, active noise cancellation, and adaptive control, to the monitoring and treatment of highly complex physiological systems. A few clinical trials illustrate the potentials of the wearable sensor technology for future heath care services.

Monitoring progression of clinical reasoning skills during health sciences education using the case method - a qualitative observational study.

Science.gov (United States)

Orban, Kristina; Ekelin, Maria; Edgren, Gudrun; Sandgren, Olof; Hovbrandt, Pia; Persson, Eva K

2017-09-11

Outcome- or competency-based education is well established in medical and health sciences education. Curricula are based on courses where students develop their competences and assessment is also usually course-based. Clinical reasoning is an important competence, and the aim of this study was to monitor and describe students' progression in professional clinical reasoning skills during health sciences education using observations of group discussions following the case method. In this qualitative study students from three different health education programmes were observed while discussing clinical cases in a modified Harvard case method session. A rubric with four dimensions - problem-solving process, disciplinary knowledge, character of discussion and communication - was used as an observational tool to identify clinical reasoning. A deductive content analysis was performed. The results revealed the students' transition over time from reasoning based strictly on theoretical knowledge to reasoning ability characterized by clinical considerations and experiences. Students who were approaching the end of their education immediately identified the most important problem and then focused on this in their discussion. Practice knowledge increased over time, which was seen as progression in the use of professional language, concepts, terms and the use of prior clinical experience. The character of the discussion evolved from theoretical considerations early in the education to clinical reasoning in later years. Communication within the groups was supportive and conducted with a professional tone. Our observations revealed progression in several aspects of students' clinical reasoning skills on a group level in their discussions of clinical cases. We suggest that the case method can be a useful tool in assessing quality in health sciences education.

Shear Wave Elastography (SWE) for Monitoring of Treatment of Tendinopathies: A Double-blinded, Longitudinal Clinical Study.

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Dirrichs, Timm; Quack, Valentin; Gatz, Matthias; Tingart, Markus; Rath, Björn; Betsch, Marcel; Kuhl, Christiane K; Schrading, Simone

2018-03-01

We aimed to investigate the diagnostic accuracy with which shear wave elastography (SWE) can be used to monitor response to treatment of tendinopathies, and to compare it to conventional ultrasound (US)-imaging methods (B-mode US (B-US) and power Doppler US (PD-US)). A prospective Institutional Review Board-approved longitudinal study on 35 patients with 47 symptomatic tendons (17 Achilles-, 15 patellar-, and 15 humeral-epicondylar) who underwent standardized multimodal US and standardized clinical assessment before and after 6 months of treatment (tailored stretching exercise, sport break, and local Polidocanol) was carried out. All US studies were performed by radiologists blinded to the clinical symptoms on both tendon sides to avoid biased interpretations, by B-US, PD-US, and SWE, conducted in the same order, using a high-resolution linear 15 MHz probe (Aixplorer). Orthopedic surgeons who were in turn blinded to US imaging results used established orthopedic scores (Victorian Institute of Sports Assessment questionnaire for Achilles, Victorian Institute of Sports Assessment questionnaire for patellar tendons, and Disability Arm Shoulder Hand scoring system) to rate presence, degree, and possible resolution of symptoms. We analyzed the diagnostic accuracy with which the different US imaging methods were able to detect symptomatic tendons at baseline as well as treatment effects, with orthopedic scores serving as reference standard. B-US, PD-US, and SWE detected symptomatic tendons with a sensitivity of 66% (31 of 47), 72% (34 of 47), and 87.5% (41 of 47), respectively. Positive predictive value was 0.67 for B-US, 0.87 for PD-US, and 1 for SWE. After treatment, clinical scores improved in 68% (32 of 47) of tendons. Treatment effects were observable by B-US, PD-US, and SWE with a sensitivity of 3.1% (1 of 32), 28.1% (9 of 32), and 81.3% (26 of 32), respectively. B-US was false-positive in 68.8% (20 of 32), PD-US in 46.9% (15 of 32), and SWE in 12.5% (4 of 32

Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial.

Science.gov (United States)

Lind, Marcus; Polonsky, William; Hirsch, Irl B; Heise, Tim; Bolinder, Jan; Dahlqvist, Sofia; Schwarz, Erik; Ólafsdóttir, Arndís Finna; Frid, Anders; Wedel, Hans; Ahlén, Elsa; Nyström, Thomas; Hellman, Jarl

2017-01-24

The majority of individuals with type 1 diabetes do not meet recommended glycemic targets. To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections. Open-label crossover randomized clinical trial conducted in 15 diabetes outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 that included 161 individuals with type 1 diabetes and hemoglobin A1c (HbA1c) of at least 7.5% (58 mmol/mol) treated with multiple daily insulin injections. Participants were randomized to receive treatment using a continuous glucose monitoring system or conventional treatment for 26 weeks, separated by a washout period of 17 weeks. Difference in HbA1c between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied. Among 161 randomized participants, mean age was 43.7 years, 45.3% were women, and mean HbA1c was 8.6% (70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA1c was 7.92% (63 mmol/mol) during continuous glucose monitoring use and 8.35% (68 mmol/mol) during conventional treatment (mean difference, -0.43% [95% CI, -0.57% to -0.29%] or -4.7 [-6.3 to -3.1 mmol/mol]; P < .001). Of 19 secondary end points comprising psychosocial and various glycemic measures, 6 met the hierarchical testing criteria of statistical significance, favoring continuous glucose monitoring compared with conventional treatment. Five patients in the conventional treatment group and 1 patient in the continuous glucose monitoring group had severe hypoglycemia. During washout when patients used conventional therapy, 7 patients had severe hypoglycemia. Among patients with inadequately controlled type 1 diabetes treated with multiple daily insulin injections, the use of continuous glucose monitoring compared with conventional treatment for 26 weeks resulted in lower HbA1c. Further research is needed to assess clinical outcomes and longer

The Johns Hopkins RTR Consortium: A Collaborative Approach to Advance Translational Science and Standardize Clinical Monitoring of Restorative Transplantation - Immunomodulation and Tolerance Induction after VCA using Biologic Agent (cTLA4-Ig) and Donor Bone Marrow Cells

Science.gov (United States)

2014-10-01

Standardize Clinical Monitoring of Restorative Transplantation – Immunomodulation and Tolerance Induction after VCA using Biologic Agent (cTLA4-Ig) and...Translational Science and Standardize Clinical Monitoring of Restorative Transplantation – Immunomodulation and Tolerance Induction after VCA using Biologic...wider application. Thus the purpose of this project is to develop novel clinically relevant regimens for immunomodulation and tolerance induction after

Outcomes from monitoring of patients on antiretroviral therapy in resource-limited settings with viral load, CD4 cell count, or clinical observation alone: a computer simulation model

DEFF Research Database (Denmark)

Phillips, Andrew N; Pillay, Deenan; Miners, Alec H

2008-01-01

BACKGROUND: In lower-income countries, WHO recommends a population-based approach to antiretroviral treatment with standardised regimens and clinical decision making based on clinical status and, where available CD4 cell count, rather than viral load. Our aim was to study the potential consequenc...... laboratory monitoring-is currently the highest priority....

[Good clinical practices in clinical trials: the responsibility of the researcher. A survey of 827 hospital physicians (I). Availability. Monitoring. Safety. Contract].

Science.gov (United States)

Dal-Ré, R

1993-03-06

The Law of Medicaments establishes that clinical trials (CT) with drugs must be carried out following the of Good Clinical Practice guidelines (GCP). The attitude of hospital physicians to the GCP prior to its implementation as mandatory in accordance with Spanish legislation was considered to be of interest. An anonymous survey was used with closed response questions. Questions referring to the responsibilities of the investigator included in the GCP were included. From December 1988 to February 1990 the survey was distributed among 1,706 hospital medical staff members, of any specialty, who had or had not participated in CT. In this article the results of the questions regarding the availability of the investigative team, CT monitorization, management of adverse reactions, the safety of the participants in the CT and the contract between the sponsor and the researcher are presented. A total of 827 hospital doctors replied to the survey. Fifty-nine percent had intervened in CT with drugs. At least 94% of those surveyed considered that the researcher must have the time and number of eligible patients which the CT requires. There was high acceptance (> or = 78%) of the clinical audits to be performed by the health authorities and the sponsor company of the CT. The need of urgent communication of the severe adverse reactions is admitted by a great majority (> or = 95%) of those surveyed. Eighty-five percent believe that patients should be insured against damage derived from CT with 76% considering that the investigator should sign a contract with the sponsor; 68% and 59% would hand in a copy of the same to the CT committee and the remainder of the research team, respectively. According to the Good Clinical Practice dealt with in this article, the responsibilities of the investigator have been widely accepted by the hospital physicians surveyed, therefore no problems should be expected upon the implementation of the same in this country. However, the economic

Pathology consultation on anticoagulation monitoring: factor X-related assays.

Science.gov (United States)

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.

Using a portable sulfide monitor as a motivational tool: a clinical study.

Science.gov (United States)

Uppal, Ranjit Singh; Malhotra, Ranjan; Grover, Vishakha; Grover, Deepak

2012-01-01

Bad breath has a significant impact on daily life of those who suffer from it. Oral malodor may rank only behind dental caries and periodontal disease as the cause of patient's visit to dentist. An aim of this study was to use a portable sulfide monitor as a motivational tool for encouraging the patients towards the better oral hygiene by correlating the plaque scores with sulfide monitor scores, and comparing the sulfide monitor scores before and after complete prophylaxis and 3 months after patient motivation. 30 patients with chronic periodontitis, having chief complaint of oral malodor participated in this study. At first visit, the plaque scores (P1) and sulfide monitor scores before (BCR1) and after complete oral prophylaxis (BCR2) were taken. Then the patients were motivated towards the better oral hygiene. After 3 months, plaque scores (P2) and sulfide monitor scores (BCR3) were recorded again. It was done using SPSS (student package software for statistical analysis). Paired sample test was performed. Statistically significant reduction in sulfide monitor scores was reported after the complete oral prophylaxis and 3 months after patient motivation. Plaque scores were significantly reduced after a period of 3 months. Plaque scores and breathchecker scores were positively correlated. An intensity of the oral malodor was positively correlated with the plaque scores. The portable sulfide monitor was efficacious in motivating the patients towards the better oral hygiene.

Arrhythmogenic effects of hypoglycemia in children and adolescents with type 1 diabetes mellitus

Directory of Open Access Journals (Sweden)

Dmitriy Nikitich Laptev

2013-12-01

Full Text Available Aim. To determine the effects of hypoglycemia on the duration of QT interval, heart rate variability (HRV and frequency of arrhythmic events, as well as to closer investigate the factors associated with the development of various heart rhythm disorders in children and adolescents with type 1 diabetes mellitus (T1DM. Materials and methods.  The study included 150 children and adolescents with T1DM at the age of 6?18 years. All participants underwent Holter monitoring and continuous glucose monitoring (CGM for 24 hours. QTc and HRV parameters (SDNN, RMSSD, SVVR were calculated automatically. Data was averaged for 5?-interval and juxtaposed with CGM. Patients identified with hypoglycemic events (blood glucose

Clinical use of continuous glucose monitoring in adults with type 1 diabetes

OpenAIRE

Slattery, David; Choudhary, Pratik

2017-01-01

With the emphasis on intensive management of type 1 diabetes, data from studies support frequent monitoring of glucose levels to improve glycemic control and reduce glucose variability, which can be related to an increase in macro and microvascular complications. However, few perform capillary blood glucose that frequently. There are currently two available alternatives that this review will discuss, continuous glucose monitoring (CGM) and flash glucose monitoring. CGM has become an important...

Clinical value of Flash glucose monitoring in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion.

Science.gov (United States)

Moreno-Fernandez, Jesus; Pazos-Couselo, Marcos; González-Rodriguez, Maria; Rozas, Pedro; Delgado, Manuel; Aguirre, Miguel; Garcia-Lopez, Jose Manuel

2018-06-12

To analyze the clinical impact of the Flash glucose monitoring system in patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII). A 24-week retrospective cohort study in CSII-treated T1DM patients exposed (1:1) to the Flash glucose monitoring system vs. self-monitoring of capillary blood glucose (SMBG). The primary outcome was the difference in hemoglobin A1c (HbA1c) levels between both groups at the end of the study. Thirty-six patients with a mean age of 38.2 years (range 22-55) and a mean T1DM duration of 20.9±7.8 years, treated with CSII for 7.1±5.4 years, were enrolled into the study. At the end of the study, mean HbA1c levels improved in patients in the Flash group (7.1±0.7 vs. 7.8±1.0, p=0.04). Only the Flash group showed a significant decrease in HbA1c levels of -0.4% (95% CI, -0.6, -0.2; p=0.004) during follow-up. Flash patients captured 93.9% of data through 17.8±9.9 scans daily. In fact, the Flash cohort showed a three-fold increase in daily self-monitoring of glucose, while daily frequency of SMBG decreased during the study (-1.8 tests/24h (95% CI -3, -0.7; p=0.01). No safety issues related to Flash use were recorded. The Flash glucose monitoring system is a novel approach to improve blood glucose control in CSII-treated T1DM patients. Randomized controlled trials are needed to assess the effectiveness of this system in CSII-treated T1DM patients. Copyright © 2018 SEEN y SED. Publicado por Elsevier España, S.L.U. All rights reserved.

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

Science.gov (United States)

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

2016-11-01

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

Monitoring CSF proteome alterations in amyotrophic lateral sclerosis: obstacles and perspectives in translating a novel marker panel to the clinic.

Directory of Open Access Journals (Sweden)

Nils von Neuhoff

Full Text Available BACKGROUND: Amyotrophic lateral sclerosis (ALS is a fatal disorder of the motor neuron system with poor prognosis and marginal therapeutic options. Current clinical diagnostic criteria are based on electrophysiological examination and exclusion of other ALS-mimicking conditions. Neuroprotective treatments are, however, most promising in early disease stages. Identification of disease-specific CSF biomarkers and associated biochemical pathways is therefore most relevant to monitor disease progression, response to neuroprotective agents and to enable early inclusion of patients into clinical trials. METHODS AND FINDINGS: CSF from 35 patients with ALS diagnosed according to the revised El Escorial criteria and 23 age-matched controls was processed using paramagnetic bead chromatography for protein isolation and subsequently analyzed by MALDI-TOF mass spectrometry. CSF protein profiles were integrated into a Random Forest model constructed from 153 mass peaks. After reducing this peak set to the top 25%, a classifier was built which enabled prediction of ALS with high accuracy, sensitivity and specificity. Further analysis of the identified peptides resulted in a panel of five highly sensitive ALS biomarkers. Upregulation of secreted phosphoprotein 1 in ALS-CSF samples was confirmed by univariate analysis of ELISA and mass spectrometry data. Further quantitative validation of the five biomarkers was achieved in an 80-plex Multiple Reaction Monitoring mass spectrometry assay. CONCLUSIONS: ALS classification based on the CSF biomarker panel proposed in this study could become a valuable predictive tool for early clinical risk stratification. Of the numerous CSF proteins identified, many have putative roles in ALS-related metabolic processes, particularly in chromogranin-mediated secretion signaling pathways. While a stand-alone clinical application of this classifier will only be possible after further validation and a multicenter trial, it could be

Investigating the application of motion accelerometers as a sleep monitoring technique and the clinical burden of the intensive care environment on sleep quality: study protocol for a prospective observational study in Australia.

Science.gov (United States)

Delaney, Lori J; Currie, Marian J; Huang, Hsin-Chia Carol; Litton, Edward; Wibrow, Bradley; Lopez, Violeta; Haren, Frank Van

2018-01-21

Sleep is a state of quiescence that facilitates the significant restorative processes that enhance individuals' physiological and psychological well-being. Patients admitted to the intensive care unit (ICU) experience substantial sleep disturbance. Despite the biological importance of sleep, sleep monitoring does not form part of standard clinical care for critically ill patients. There exists an unmet need to assess the feasibility and accuracy of a range of sleep assessment techniques that have the potential to allow widespread implementation of sleep monitoring in the ICU. The coprimary outcome measures of this study are to: determine the accuracy and feasibility of motion accelerometer monitoring (ie, actigraphy) and subjective assessments of sleep (nursing-based observations and patient self-reports) to the gold standard of sleep monitoring (ie, polysomnography) in evaluating sleep continuity and disturbance. The secondary outcome measures of the study will include: (1) the association between sleep disturbance and environmental factors (eg, noise, light and clinical interactions) and (2) to describe the sleep architecture of intensive care patients. A prospective, single centre observational design with a within subjects' assessment of sleep monitoring techniques. The sample will comprise 80 adults (aged 18 years or more) inclusive of ventilated and non-ventilated patients, admitted to a tertiary ICU with a Richmond Agitation-Sedation Scale score between +2 (agitated) and -3 (moderate sedation) and an anticipated length of stay >24 hours. Patients' sleep quality, total sleep time and sleep fragmentations will be continuously monitored for 24 hours using polysomnography and actigraphy. Behavioural assessments (nursing observations) and patients' self-reports of sleep quality will be assessed during the 24-hour period using the Richards-Campbell Sleep Questionnaire, subjective sleepiness evaluated via the Karolinska Sleepiness Scale, along with a

Monitoring additive manufacturing based products in clinical trials

NARCIS (Netherlands)

Marinakis, Yorgos; Harms, Rainer; Walsh, Steven Thomas

2017-01-01

Under U.S. federal regulation 31 CFR §312, medical interventions must report on a series of clinical trials phases before being submitted for approval for release to the U.S. market. Clinical trials are now being performed on medical interventions that were constructed through additive

Clinical indicators to monitor patients with risk for ineffective cerebral tissue perfusion

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Miriam de Abreu Almeida

2015-04-01

Full Text Available Objective. Select and validate the clinical indicators to monitor patients on risk for ineffective cerebral tissue perfusion, according to the Nursing Outcomes Classification (NOC. Methodology. Validation study carried out between November 2012 and August 2013, in a Brazilian hospital. Seventeen judges nurses evaluated the clinical indicators of Nursing Outcomes, according to NOC for patients on risk for ineffective cerebral tissue perfusion. In the first stage, were selected the nursing results for the assessment of the studied diagnosis and, in the second nurses assessment the importance of the indicators of the validated results in the previous step through a five points Likert scale (1 = not important to 5 = extremely important. Were used the content validity index (CVI that corresponds to the calculation of weighted averages of them marks awarded for each indicator, as it considered the following weights: 1=0.00, 2=0.25, 3=0.50; 4=0.75; 5=1.00. For categorization, the CVI considered as critical = ≥0.80; supplementary =≥0.50 to 0.79 and were disposed results <0.50. Results. Of the 9 nursing results, only the cerebral tissue perfusion obtained a 100% consensus. The CVI of the 18 indicators of this result showed that five were validated as critical (impaired neurological reflexes, systolic blood pressure, diastolic blood pressure, reduced level of consciousness and mean arterial pressure, 12 were validated as supplementary (Agitation, Impaired cognition, Intracranial pressure, Syncope, Vomiting, Findings of cerebral angiography, Headache, Restlessness, Fever, Unexplained anxiety, listlessness and Hiccughs and one was disposed (carotid bruit. Conclusions. The validation of information about the conditions of risk may allow early intervention to minimize the consequences of ineffective cerebral tissue perfusion.

Amikacin Dosing and Monitoring in Spinal Cord Injury Patients: Variation in Clinical Practice Between Spinal Injury Units and Differences in Experts' Recommendations

Directory of Open Access Journals (Sweden)

Subramanian Vaidyanathan

2006-01-01

Full Text Available The objective of this article was to determine the current practice on amikacin dosing and monitoring in spinal cord injury patients from spinal cord physicians and experts. Physicians from spinal units and clinical pharmacologists were asked to provide protocol for dosing and monitoring of amikacin therapy in spinal cord injury patients. In a spinal unit in Poland, amikacin is administered usually 0.5 g twice daily. A once-daily regimen of amikacin is never used and amikacin concentrations are not determined. In Belgium, Southport (U.K., Spain, and the VA McGuire Medical Center (Richmond, Virginia, amikacin is given once daily. Whereas peak and trough concentrations are determined in Belgium, only trough concentration is measured in Southport. In both these spinal units, modification of the dose is not routinely done with a nomogram. In Spain and the VA McGuire Medical Center, monitoring of serum amikacin concentration is not done unless a patient has renal impairment. In contrast, the dose/interval of amikacin is adjusted according to pharmacokinetic parameters at the Edward Hines VA Hospital (Hines, Illinois, where amikacin is administered q24h or q48h, depending on creatinine clearance. Spinal cord physicians from Denmark, Germany, and the Kessler Institute for Rehabilitation (West Orange, New Jersey state that they do not use amikacin in spinal injury patients. An expert from Canada does not recommend determining serum concentrations of amikacin, but emphasizes the value of monitoring ototoxicity and nephrotoxicity. Experts from New Zealand recommend amikacin in conventional twice- or thrice-daily dosing because of the theoretical increased risk of neuromuscular blockade and apnea with larger daily doses in spinal cord injury patients. On the contrary, experts from Greece, Israel, and the U.S. recommend once-daily dosing and determining amikacin pharmacokinetic parameters for each patient. As there is considerable variation in clinical

Syncope in children with hypertrophic cardiomyopathy

Directory of Open Access Journals (Sweden)

I. V. Leontyeva

2014-01-01

Full Text Available Seventy children aged 7 to 17 years with hypertrophic cardiomyopathy (HCM were examined; among them there were 11 syncope patients and 5 presyncope patients. The screening program included standard electrocardiography (ECG, Doppler echocardiogra-phy, 24-hour Holter ECG monitoring, and an incremental exercise testing (Bruce treadmill test. The markers of myocardial electrical instability were determined. In the children with HCM, syncope was established to be heterogeneous; it had an arrhythmogenic origin and, in most cases, occurred in the presence of tachyarrhythmia (44% or bradyarrythmia (25%; its vasovagal genesis was probable in one third of the examinees. The children with syncope were typified by the asymmetric, obstructive form of HCM, at the same tone there was most commonly left ventricular hypertrophy concurrent with left atrial enlargement. 24-hour Holter monitoring showed that bradycardia was prevalent in the patients, 3 patients were found to have more than 2-second cardiac rhythm pauses caused by second-degree atrioventricular block in 1 case or by sick sinus syndrome in 2. Nonsustained ventricular tachycardia was noted in two patients. The children with syncope were typified by the signs of myocardial electrical instability as a reduction in the early phase of heart rate turbulence and by impaired QT/RR interval adaptation as hyperadaptation. The paper presents the developed management tactics for children with syncope and indications for the implantation of a cardioverter defibrillator, a pacemaker, or an ECG loop recorder.

Concurrent measurement of "real-world" stress and arousal in individuals with psychosis: assessing the feasibility and validity of a novel methodology.

Science.gov (United States)

Kimhy, David; Delespaul, Philippe; Ahn, Hongshik; Cai, Shengnan; Shikhman, Marina; Lieberman, Jeffrey A; Malaspina, Dolores; Sloan, Richard P

2010-11-01

Psychosis has been repeatedly suggested to be affected by increases in stress and arousal. However, there is a dearth of evidence supporting the temporal link between stress, arousal, and psychosis during "real-world" functioning. This paucity of evidence may stem from limitations of current research methodologies. Our aim is to the test the feasibility and validity of a novel methodology designed to measure concurrent stress and arousal in individuals with psychosis during "real-world" daily functioning. Twenty patients with psychosis completed a 36-hour ambulatory assessment of stress and arousal. We used experience sampling method with palm computers to assess stress (10 times per day, 10 AM → 10 PM) along with concurrent ambulatory measurement of cardiac autonomic regulation using a Holter monitor. The clocks of the palm computer and Holter monitor were synchronized, allowing the temporal linking of the stress and arousal data. We used power spectral analysis to determine the parasympathetic contributions to autonomic regulation and sympathovagal balance during 5 minutes before and after each experience sample. Patients completed 79% of the experience samples (75% with a valid concurrent arousal data). Momentary increases in stress had inverse correlation with concurrent parasympathetic activity (ρ = -.27, P feasibility and validity of our methodology in individuals with psychosis. The methodology offers a novel way to study in high time resolution the concurrent, "real-world" interactions between stress, arousal, and psychosis. The authors discuss the methodology's potential applications and future research directions.

Depressed heart rate variability as an independent predictor of death in chronic congestive heart failure secondary to ischemic or idiopathic dilated cardiomyopathy.

Science.gov (United States)

Ponikowski, P; Anker, S D; Chua, T P; Szelemej, R; Piepoli, M; Adamopoulos, S; Webb-Peploe, K; Harrington, D; Banasiak, W; Wrabec, K; Coats, A J

1997-06-15

After acute myocardial infarction, depressed heart rate variability (HRV) has been proven to be a powerful independent predictor of a poor outcome. Although patients with chronic congestive heart failure (CHF) have also markedly impaired HRV, the prognostic value of HRV analysis in these patients remains unknown. The aim of this study was to investigate whether HRV parameters could predict survival in 102 consecutive patients with moderate to severe CHF (90 men, mean age 58 years, New York Heart Association [NYHA] class II to IV, CHF due to idiopathic dilated cardiomyopathy in 24 patients and ischemic heart disease in 78 patients, ejection fraction [EF], 26%; peak oxygen consumption, 16.9 ml/kg/min) after exclusion of patients in atrial fibrilation with diabetes or with chronic renal failure. In the prognostic analysis (Cox proportional-hazards model, Kaplan-Meier survival analysis), the following factors were investigated: age, CHF etiology, NYHA class, EF, peak oxygen consumption, presence of ventricular tachycardia on Holter monitoring, and HRV measures derived from 24-hour electrocardiography monitoring, calculated in the time (standard deviation of all normal RR intervals [SDNN], standard deviation of 5-minute RR intervals [SDANN], mean of all 5-minute standard deviations of RR intervals [SD], root-mean-square of difference of successive RR intervals [rMSSD], and percentage of adjacent RR intervals >50 ms different [pNN50]) and frequency domain (total power [TP], power within low-frequency band [LF], and power within high-frequency band [HF]). During follow-up of 584 +/- 405 days (365 days in all who survived), 19 patients (19%) died (mean time to death: 307 +/- 315 days, range 3 to 989). Cox's univariate analysis identified the following factors to be predictors of death: NYHA (p = 0.003), peak oxygen consumption (p = 0.01), EF (p = 0.02), ventricular tachycardia on Holter monitoring (p = 0.05), and among HRV measures: SDNN (p = 0.004), SDANN (p = 0.003), SD

The Clinical Utilisation of Respiratory Elastance Software (CURE Soft): a bedside software for real-time respiratory mechanics monitoring and mechanical ventilation management.

Science.gov (United States)

Szlavecz, Akos; Chiew, Yeong Shiong; Redmond, Daniel; Beatson, Alex; Glassenbury, Daniel; Corbett, Simon; Major, Vincent; Pretty, Christopher; Shaw, Geoffrey M; Benyo, Balazs; Desaive, Thomas; Chase, J Geoffrey

2014-09-30

Real-time patient respiratory mechanics estimation can be used to guide mechanical ventilation settings, particularly, positive end-expiratory pressure (PEEP). This work presents a software, Clinical Utilisation of Respiratory Elastance (CURE Soft), using a time-varying respiratory elastance model to offer this ability to aid in mechanical ventilation treatment. CURE Soft is a desktop application developed in JAVA. It has two modes of operation, 1) Online real-time monitoring decision support and, 2) Offline for user education purposes, auditing, or reviewing patient care. The CURE Soft has been tested in mechanically ventilated patients with respiratory failure. The clinical protocol, software testing and use of the data were approved by the New Zealand Southern Regional Ethics Committee. Using CURE Soft, patient's respiratory mechanics response to treatment and clinical protocol were monitored. Results showed that the patient's respiratory elastance (Stiffness) changed with the use of muscle relaxants, and responded differently to ventilator settings. This information can be used to guide mechanical ventilation therapy and titrate optimal ventilator PEEP. CURE Soft enables real-time calculation of model-based respiratory mechanics for mechanically ventilated patients. Results showed that the system is able to provide detailed, previously unavailable information on patient-specific respiratory mechanics and response to therapy in real-time. The additional insight available to clinicians provides the potential for improved decision-making, and thus improved patient care and outcomes.

Comparison of image quality between mammography dedicated monitor and UHD 4K monitor, using standard mammographic phantom: A preliminary study

Energy Technology Data Exchange (ETDEWEB)

Lee, Ji Young; Cha, Soon Joo; Hong, Sung Hwan; Kim, Su Young; Kim, Yong Hoon; Kim, You Sung; Kim, Jeong A [Dept. of Radiology, Inje Unveristy Ilsan Paik Hospital, Goyang (Korea, Republic of)

2017-03-15

Using standard mammographic phantom images, we compared the image quality obtained between a mammography dedicated 5 megapixel monitor (5M) and a UHD 4K (4K) monitor with digital imaging and communications in medicine display, to investigate the possibility of clinical application of 4K monitors. Three different exposures (autoexposure, overexposure and underexposure) images of mammographic phantom were obtained, and six radiologists independently evaluated the images in 5M and 4K without image modulation, by scoring of fibers, groups of specks and masses within the phantom image. The mean score of each object on both monitors was independently analyzed, using t-test and interobserver reliability by intraclass correlation coefficient (ICC) of SPSS. The overall mean scores of fiber, group of specks, and mass in 5M were 4.25, 3.92, and 3.28 respectively, and scores obtained in 4K monitor were 3.81, 3.58, and 3.14, respectively. No statistical difference was seen in scores of fiber and mass between the two monitors at all exposure conditions, but the score of group of specks in 4K was statistically lower in the overall (p = 0.0492) and in underexposure conditions (p = 0.012). The ICC for interobserver reliability was excellent (0.874). Our study suggests that since the mammographic phantom images are appropriate with no significant difference in image quality observed between the two monitors, the 4K monitor could be used for clinical studies. Since this is a small preliminary study using phantom images, the result may differ in actual mammographic images, and subsequent investigation with clinical mammographic images is required.

Silent ischemia in patients after the acute myocardial infarction

International Nuclear Information System (INIS)

Samarzija, M.

1991-01-01

The purpose of this study was to determine the frequency and importance of silent ischemia in patients (pts) after acute myocardial infarction (AMI) as well as to establish diagnostic and prognostic values of exercise stress test (EST), Holter (H) monitoring and thallium-201 (Tl) scintigraphy. All the tests were performed 2-4 months following the AMI. The criterion for diagnostic myocardial ischemia on EST and H is 1 mm or more of horizontal or down-sloping ST depression. Additional criteria for Holter imply that the ischemic episode should last one minute and be separated from other episodes by at least one minute. Planar thallium images were performed 5-10 minutes after the stress test; the delayed images were obtained after 3-6 hours. Visual and quantitative methods were employed in the analysis of Tl-scintigraphy. Scintigraphy was considered positive if exercise-induced perfusion defects showed redistribution. The study included 74 asymptomatic patients after the AMI. The patients were divided into two groups by results of quantitative Tl-scintigraphy: Group I - 44 pts with silent ischemia, Group II - 30 pts without ischemia. In Group I, out of 44 pts, 9 had a positive exercise stress test, 4 showed a painless ST depression on Holter and 7 had both tests positive, whereas 24 pts had only scintigraphy positive. In Group II one patient had positive EST and H. Sensitivity and specificity were determined by results of coronary arteriography performed on 33 pts: EST (Se=40%, Sp=80%), H (Se=21%, Sp=100%) and scintigraphy (Se=93%, Sp=80%). During the follow-up period lasting at least 12 months, in Group I 3 pts died, 1 developed a new myocardial infarction and 15 pts had painful ischemic occurrences. In Group II only 3 pts developed symptoms of angina pectoris. Tl-scintigraphy was the only non-invasive test showing significant correlation with the follow-up outcomes. The diagnostic and prognostic superiority of Tl-scintigraphy justifies its value as an initial

Silent ischemia in patients after uncomplicated myocardial infarction

International Nuclear Information System (INIS)

Samarzija, M.; Tezak, S.

1994-01-01

The purpose of this study was to determine the frequency and importance of silent ischemia in patients (pts) after the acute myocardial infarction (A MI) as well as to establish diagnostic and prognostic value of exercise stress test (EST), Holter (H) monitoring and thallium-201 (Tl) scintigraphy. All the three tests were performed 2-4 months following the AMI. The criterion for diagnosing myocardial ischemia on EST and H is 1 mm or more of horizontal or down-sloping ST depression. Additional criteria for Holter imply the ischemic episode should last one minute and be separated from other episodes by at least one minute. Planar thallium images were performed 5-10 minute after the stress test; the delayed images were obtained after 3-6 hours. Visual and quantitative methods were employed in the analysis of TI-scintigraphy. Scintigraphy was considered positive if exercise- induced perfusion defects showed redistribution. The study included 74 asymptomatic patients after the AMI. The patients were divided into two groups by results of quantitative Tl-scintigraphy: Group I - 44 pts with silent ischemia, Group II - 30 pts without ischemia. In Group I, out of 44 pts, 9 had a positive exercise stress, 4 showed a painless ST depression on Holter and 7 had both tests positive, whereas 24 pts had only scintigraphy positive. In Group II one patient had positive EST and H. Sensitivity and specificity were determined by results of coronary arteriography performed on 33 pts: EST (Se=40%, Sp=80%), H (Se=219, Sp=100%) and scintigraphy (Se=93%, Sp =80%). During the follow-up period lasting at least 12 months, in Group I 3 pts died, 1 developed a new myocardial infarction and 15 pts had painful ischemic occurrences. In Group II only 3 pts developed symptoms of angina pectoris. Tl-scintigraphy was the only non-invasive test showing significant correlation with the follow-up outcomes. The diagnostic and prognostic superiority of Tl-scintigraphy justifies its value as the initial

Clinical Significance of Monitoring Serum β-HCG in the Conservative Treatment of Ectopic Pregnancy

International Nuclear Information System (INIS)

Chen Xue

2010-01-01

To explore the clinical value of the serum β-HCG (human chorionic gonadotrophin) in the conservative treatment of ectopic pregnancy, the serum β-HCG levels in 118 patients with ectopic pregnancy were measured with RIA. The results showed that the serum β-HCG levels in patients with successful conservative treatment of ectopic pregnancy were all less than 200mIU/mL. The patients require a surgical treatment to reach <200mIU/mL serum β-HCG concentration were only 26.3%. There was significant difference between two groups (P<0.01). The monitoring of serum β-HCG was very useful in the diagnosis, the choice of treatment measures and the evaluation of conservative treatment effect of ectopic pregnancy. In the course of treatment of ectopic pregnancy, serum β-HCG is a good marker in determining the success or failure of treatment. (authors)

Multimodal brain monitoring in fulminant hepatic failure

Science.gov (United States)

Paschoal Jr, Fernando Mendes; Nogueira, Ricardo Carvalho; Ronconi, Karla De Almeida Lins; de Lima Oliveira, Marcelo; Teixeira, Manoel Jacobsen; Bor-Seng-Shu, Edson

2016-01-01

Acute liver failure, also known as fulminant hepatic failure (FHF), embraces a spectrum of clinical entities characterized by acute liver injury, severe hepatocellular dysfunction, and hepatic encephalopathy. Cerebral edema and intracranial hypertension are common causes of mortality in patients with FHF. The management of patients who present acute liver failure starts with determining the cause and an initial evaluation of prognosis. Regardless of whether or not patients are listed for liver transplantation, they should still be monitored for recovery, death, or transplantation. In the past, neuromonitoring was restricted to serial clinical neurologic examination and, in some cases, intracranial pressure monitoring. Over the years, this monitoring has proven insufficient, as brain abnormalities were detected at late and irreversible stages. The need for real-time monitoring of brain functions to favor prompt treatment and avert irreversible brain injuries led to the concepts of multimodal monitoring and neurophysiological decision support. New monitoring techniques, such as brain tissue oxygen tension, continuous electroencephalogram, transcranial Doppler, and cerebral microdialysis, have been developed. These techniques enable early diagnosis of brain hemodynamic, electrical, and biochemical changes, allow brain anatomical and physiological monitoring-guided therapy, and have improved patient survival rates. The purpose of this review is to discuss the multimodality methods available for monitoring patients with FHF in the neurocritical care setting. PMID:27574545

VLSI in medicine

CERN Document Server

Einspruch, Norman G

1989-01-01

VLSI Electronics Microstructure Science, Volume 17: VLSI in Medicine deals with the more important applications of VLSI in medical devices and instruments.This volume is comprised of 11 chapters. It begins with an article about medical electronics. The following three chapters cover diagnostic imaging, focusing on such medical devices as magnetic resonance imaging, neurometric analyzer, and ultrasound. Chapters 5, 6, and 7 present the impact of VLSI in cardiology. The electrocardiograph, implantable cardiac pacemaker, and the use of VLSI in Holter monitoring are detailed in these chapters. The

A passive acoustic monitor of treatment effectiveness during extracorporeal lithotripsy

Science.gov (United States)

Fedele, F.; Thomas, K.; Leighton, T. G.; Ryves, S.; Phillips, D.; Coleman, A. J.

2011-02-01

Although extracorporeal shockwave lithotripsy (ESWL) has now been in the clinic for at least three decades, there has been little advance in efforts (i) to estimate the efficacy of the treatment whilst it is in progress, or (ii) to determine the end-point of a treatment session in terms of the degree of stone fragmentation achieved. Previous in vitro experimentation and clinical trials have shown that a passive acoustic monitor has the potential to provide evidence of the effectiveness and end-point of lithotripsy. The system exploits secondary emissions generated during shock-tissue interaction, whose features depend on the quality of tissue at the beam focus. This prototype was developed into the first commercially available clinical ESWL treatment monitor (Precision Acoustic Ltd, Dorchester, UK), and a unit has been acquired and tested in the clinical routine by urologists at Guy's and St Thomas NHS Trust in March 2009. This paper critically assesses the performance of the new system for the first 25 treatments monitored. The ESWL monitor correctly predicted the treatment outcome of 15 of the 18 treatments that were followed-up clinically. In addition, it was noted that the measure of treatment effectiveness provided by the monitor after 500 shocks was predictive of the final treatment outcome (p ESWL or if the patient should be sent for surgery.

Disease management: atrial fibrillation and home monitoring.

Science.gov (United States)

Ricci, Renato Pietro

2013-06-01

Device-detected atrial fibrillation (AF) episodes predict poor clinical outcome regardless of symptoms. Potential benefits of remote monitoring are early arrhythmia detection and patient continuous monitoring. Several studies of device remote monitoring consistently demonstrated that AF represents the most common clinical alert and that detailed information on arrhythmia onset, duration, and burden as well as on the ventricular rate may be early available for clinical evaluation. Reaction time to AF alerts was very short in all series involving either pacemakers or defibrillators and action ability of AF alerts was very high. In the Home Guide Registry, in which 1650 patients were enrolled, AF was detected in 16.3% of patients and represented 36% of all cardiovascular events during the follow-up. Timely anticoagulation introduction in asymptomatic patients may impact on the stroke rate. According to the results of repeated Monte Carlo simulations based on a real population of 166 patients, daily monitoring may reduce the 2-year stroke risk by 9-18% with an absolute reduction of 0.2-0.6%, compared with conventional inter-visit intervals of 6-12 months. In the COMPAS trial, the incidence of hospitalizations for atrial arrhythmias and related stroke was significantly higher in the control group than in the remote monitoring group. Major questions will be addressed by the ongoing IMPACT trial in which a remote monitoring guided anticoagulation strategy based on AF detection will be compared with a physician-directed standard strategy. In patients with heart failure, AF early detection combined with other indexes may help prevent hospitalizations.

Side effects of ambulatory blood pressure monitoring.

NARCIS (Netherlands)

Steen, M.S. van der; Lenders, J.W.M.; Thien, Th.

2005-01-01

OBJECTIVE: To study the experiences and complaints of patients who underwent 24 h blood pressure monitoring. METHODS: Two groups of hypertensive patients of a tertiary outpatient clinic were asked to fill in a nine-item questionnaire about the side effects of ambulatory blood pressure monitoring

Ambulatory ST segment monitoring after myocardial infarction

DEFF Research Database (Denmark)

Mickley, H

1994-01-01

as important reasons for the inconsistent findings. The precise role of ambulatory ST segment monitoring in clinical practice has yet to be established. Direct comparisons with exercise stress testing may not be appropriate for two reasons. Firstly, the main advantage of ambulatory monitoring may...

Relative value of clinical variables, bicycle ergometry, rest radionuclide ventriculography and 24 hour ambulatory electrocardiographic monitoring at discharge to predict 1 year survival after myocardial infarction

NARCIS (Netherlands)

P.M. Fioretti (Paolo); R.W. Brower (Ronald); M.L. Simoons (Maarten); H.J. ten Katen (Harald); A. Beelen (Anita); T. Baardman (Taco); J. Lubsen (Jacob); P.G. Hugenholtz (Paul)

1986-01-01

textabstractThe relative value of predischarge clinical variables, bicycle ergometry, radionuclide ventriculography and 24 hour ambulatory electrocardiographic monitoring for predicting survival during the first year in 351 hospital survivors of acute myocardial infarction was assessed. Discriminant

Electronic monitoring in bipolar disorder.

Science.gov (United States)

Faurholt-Jepsen, Maria

2018-03-01

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

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

Clinical presentation of terbinafine-induced severe liver injury and the value of laboratory monitoring: a Critically Appraised Topic.

Science.gov (United States)

Kramer, O N; Albrecht, J

2017-11-01

Many physicians monitor liver function tests during terbinafine therapy. To evaluate the symptoms of published cases of terbinafine-associated severe drug-induced liver injury (DILI) to assess the utility of laboratory monitoring. We based our search on the LiverTox database of the National Institutes of Health, but we also searched both PubMed and Embase. In addition, we hand searched the references of the papers we found. All reports of patients with DILI on terbinafine and with reported clinical symptoms, or absence thereof, were evaluated. Two independent reviewers (J.A. and O.N.K.) assessed articles for eligibility of inclusion, and collected and evaluated the data. Thirty-eight papers fulfilled the inclusion criteria, with reports of 69 symptomatic patients. The mean duration of terbinafine treatment until onset of symptoms was 30·2 days (range 5-84). Symptoms in order of frequency were jaundice, flu-like symptoms, dark urine and pruritus. Patients experienced symptoms for a mean and median of 14·8 and 16 days, respectively (range 0-42) until seeking medical attention. Patients who had DILI were symptomatic, usually with jaundice, abdominal pain and general malaise, but also with severe pruritus. No asymptomatic patient was identified through laboratory screening. The timeline of DILI onset varies significantly, but most cases occur between 4 and 6 weeks. There was no time point at which monitoring was meaningful, and we do not recommend monitoring of liver function tests on terbinafine; however, patients should be advised to discontinue treatment and look for medical care when symptoms of DILI occur. © 2017 British Association of Dermatologists.

Tools in a clinical information system supporting clinical trials at a Swiss University Hospital.

Science.gov (United States)

Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg

2014-12-01

Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient-trial-assignment-tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of

Patients' experiences with routine outcome monitoring and clinical feedback systems: A systematic review and synthesis of qualitative empirical literature.

Science.gov (United States)

Solstad, Stig Magne; Castonguay, Louis Georges; Moltu, Christian

2017-05-19

Routine outcome monitoring (ROM) and clinical feedback (CF) systems have become important tools for psychological therapies, but there are challenges for their successful implementation. To overcome these challenges, a greater understanding is needed about how patients experience the use of ROM/CF. We conducted a systematic literature search of qualitative studies on patient experiences with the use of ROM/CF in mental health services. The findings from 16 studies were synthesized, resulting in four meta-themes: (1) Suspicion towards service providers, (2) Flexibility and support to capture complexity, (3) Empowering patients, and (4) Developing collaborative practice. We discuss the implications of these meta-themes for further development and implementation of ROM/CF into clinical practice, acknowledging the limitations of our review and suggesting avenues for further research. Clinical or methodological significance of this article: This article provides useful and actionable knowledge about the patient perspective on ROM/CF, an important discussion on the current state of research in this area, and useful and concrete suggestions for further avenues of research.

Year in review in journal of clinical monitoring and computing 2014 : cardiovascular and hemodynamic monitoring

NARCIS (Netherlands)

Bendjelid, Karim; Rex, Steffen; Scheeren, Thomas; Critchley, Lester

Hemodynamic instability is a common sign in critically ill patients and its importance has been increasingly recognized during the last 20 years. Indeed, It is now appreciated that an adequate hemodynamic monitoring associated to reactive vigorous therapy is able to decrease the present ominous

Clinical usefulness of therapeutic drug monitoring of voriconazole in a university hospital.

Science.gov (United States)

Cabral-Galeano, Evelyn; Ruiz-Camps, Isabel; Len-Abad, Oscar; Pou-Clavé, Leonor; Sordé-Masip, Roger; Meije-Castillo, Yolanda; Blanco-Grau, Albert; Barba-Suñol, Pere; Monforte-Torres, Victor; Román-Broto, Antonio; Pahissa-Berga, Albert; Gavaldà-Santapau, Joan

2015-05-01

The aim of this study was to assess the clinical usefulness of therapeutic drug monitoring (TDM) of voriconazole (VOR) in a university hospital. A retrospective review was conducted on the clinical records of 52 patients treated with VOR and on whom TDM was performed. Steady-state trough plasma VOR concentration was measured at least 5 days after starting treatment. The therapeutic range of plasma VOR concentration was defined as 1-5.5μg/mL. The most frequent underlying conditions in the study population were lung transplant (48.1%) and hematological malignancies (26.9%). At the first TDM in each patient, VOR levels were outside the therapeutic range in 16 (30.7%) cases: 5.5μg/mL in 6 (11.5%). Eleven patients (21.2%) experienced severe muscle weakness and had considerable difficulty walking. All these patients were receiving concomitant treatment with corticosteroids. Age younger than 30 years (p=.005) and cystic fibrosis as the underlying disease (p=.04) were factors associated with low VOR levels. Almost all patients who had VOR concentrations >1μg/mL at the first TDM had a successful outcome (96%). Plasma VOR concentrations were outside the therapeutic range at the first TDM in 30% (16/52) of patients. Age younger than 30 years and cystic fibrosis were factors associated with low VOR levels. The potential interactions between corticosteroids and VOR should be highlighted, as they could be responsible for a high rate of muscle weakness observed in our patients. Prospective trials are needed to investigate VOR TDM and corticosteroid pharmacokinetics. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Implementation of Out-of-Office Blood Pressure Monitoring in the Netherlands: From Clinical Guidelines to Patients' Adoption of Innovation.

Science.gov (United States)

Carrera, Pricivel M; Lambooij, Mattijs S

2015-10-01

Out-of-office blood pressure monitoring is promoted by various clinical guidelines toward properly diagnosing and effectively managing hypertension and engaging the patient in their care process. In the Netherlands, however, the Dutch cardiovascular risk management (CVRM) guidelines do not explicitly prescribe 24-hour ambulatory blood pressure measurement (ABPM) and home BP measurement (HBPM). The aim of this descriptive study was to develop an understanding of patients' and physicians' acceptance and use of out-of-office BP monitoring in the Netherlands given the CVRM recommendations.Three small focus group discussions (FGDs) with patients and 1 FGD with physicians were conducted to explore the mechanisms behind the acceptance and use of out-of-office BP monitoring and reveal real-world challenges that limit the implementation of out-of-office BP monitoring methods. To facilitate the FGDs, an analytical framework based on the technology acceptance model (TAM), the theory of planned behavior and the model of personal computing utilization was developed to guide the FGDs and analysis of the transcriptions of each FGD.ABPM was the out-of-office BP monitoring method prescribed by physicians and used by patients. HBPM was not offered to patients even with patients' feedback of poor tolerance of ABPM. Even as there was little awareness about HBPM among patients, there were a few patients who owned and used sphygmomanometers. Patients professed and seemed to exhibit self-efficacy, whereas physicians had reservations about (all of their) patients' self-efficacy in properly using ABPM. Since negative experience with ABPM impacted patients' acceptance of ABPM, the interaction of factors that determined acceptance and use was found to be dynamic among patients but not for physicians.In reference to the CVRM guidelines, physicians implemented out-of-office BP monitoring but showed a strong preference for ABPM even where there is poor tolerance of the method. We found that

Assessment of readiness for clinical decision support to aid laboratory monitoring of immunosuppressive care at U.S. liver transplant centers.

Science.gov (United States)

Jacobs, J; Weir, C; Evans, R S; Staes, C

2014-01-01

Following liver transplantation, patients require lifelong immunosuppressive care and monitoring. Computerized clinical decision support (CDS) has been shown to improve post-transplant immunosuppressive care processes and outcomes. The readiness of transplant information systems to implement computerized CDS to support post-transplant care is unknown. a) Describe the current clinical information system functionality and manual and automated processes for laboratory monitoring of immunosuppressive care, b) describe the use of guidelines that may be used to produce computable logic and the use of computerized alerts to support guideline adherence, and c) explore barriers to implementation of CDS in U.S. liver transplant centers. We developed a web-based survey using cognitive interviewing techniques. We surveyed 119 U.S. transplant programs that performed at least five liver transplantations per year during 2010-2012. Responses were summarized using descriptive analyses; barriers were identified using qualitative methods. Respondents from 80 programs (67% response rate) completed the survey. While 98% of programs reported having an electronic health record (EHR), all programs used paper-based manual processes to receive or track immunosuppressive laboratory results. Most programs (85%) reported that 30% or more of their patients used external laboratories for routine testing. Few programs (19%) received most external laboratory results as discrete data via electronic interfaces while most (80%) manually entered laboratory results into the EHR; less than half (42%) could integrate internal and external laboratory results. Nearly all programs had guidelines regarding pre-specified target ranges (92%) or testing schedules (97%) for managing immunosuppressive care. Few programs used computerized alerting to notify transplant coordinators of out-of-range (27%) or overdue laboratory results (20%). Use of EHRs is common, yet all liver transplant programs were largely

Smart health monitoring systems: an overview of design and modeling.

Science.gov (United States)

Baig, Mirza Mansoor; Gholamhosseini, Hamid

2013-04-01

Health monitoring systems have rapidly evolved during the past two decades and have the potential to change the way health care is currently delivered. Although smart health monitoring systems automate patient monitoring tasks and, thereby improve the patient workflow management, their efficiency in clinical settings is still debatable. This paper presents a review of smart health monitoring systems and an overview of their design and modeling. Furthermore, a critical analysis of the efficiency, clinical acceptability, strategies and recommendations on improving current health monitoring systems will be presented. The main aim is to review current state of the art monitoring systems and to perform extensive and an in-depth analysis of the findings in the area of smart health monitoring systems. In order to achieve this, over fifty different monitoring systems have been selected, categorized, classified and compared. Finally, major advances in the system design level have been discussed, current issues facing health care providers, as well as the potential challenges to health monitoring field will be identified and compared to other similar systems.

Clinical impact of laboratory error on therapeutic drug monitoring of once-daily tobramycin in cystic fibrosis: Case series

Directory of Open Access Journals (Sweden)

William A Prescott

2014-01-01

Full Text Available Once-daily dosing intravenous tobramycin is commonly used to treat cystic fibrosis pulmonary exacerbations. Clinicians often utilize historical therapeutic drug monitoring data to individualize the dose among patients who have been treated with tobramycin previously. This case series involves three patients with cystic fibrosis who had supra-therapeutic tobramycin levels despite use of a once-daily dosing that produced therapeutic drug levels during a previous hospital admission, raising questions about the validity of these levels. Investigation into several potential sources of error led to the discovery of an analyzer error in the laboratory. Once the laboratory’s tobramycin analyzer was recalibrated, the reported levels were comparable to historical levels. This case series emphasizes the clinical importance of critically analyzing reported levels, and specifically, the importance of utilizing past therapeutic drug monitoring data, if available, for all patients treated with intravenous tobramycin. If a patient was therapeutic on a similar dose of tobramycin during a previous admission, a dose adjustment may not be necessary, and clinicians should consider repeating levels while pursuing alternative explanations for the discrepant serum levels.

Clinical significance of monitoring of serum TRAb in pregnant women with graves' disease treated by propylthiouracil

International Nuclear Information System (INIS)

Zou Jinhai; Li Xue; Wang Yansheng; Zhang Qingfeng; Wang Jianchun

2011-01-01

Objective: To discuss the change of serum TRAb and changeable regularity of thyroid function and clinical significance of pregnant women with Graves' diease treated by propylthiouracil. Methods: Detecting the serum TRAb, FT 3 , FT 4 , TSH levels of pregnant women with Graves' disease treated by propylthiouracil using radioreceptor assay and electro chemiluminescence. Results: The serum TRAb level of the pregnant women with Graves' disease in early gestation treated by propylthiouracil descended much more than that in the initial diagnosis (P<0.01). The positive rates of TRAb in the women before treated by propylthiouracil and treated 3 months, 6 months, 8 months were 90.2%, 82.9%, 68.2% and 21.9% separately. The activity of TRAb descended slightly 3 months latter after treated. The activity of TRAb descend obviously and the positive rates changed largely 8 months after treated. Conclusion: There is very important clinical significance of monitoring of serum TRAb in pregnant women with Graves' disease in diagnosis and differential diagnosis and observation of therapeutic effects. Also, a favourable prognosis judgement. Meanwhile, provides significant reference index of pathogenetic condition judgement and drug discontinuance whether or not for the clinician. (authors)

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

Science.gov (United States)

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

2014-12-15

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

Early monitoring of PtiO2, PtiCO2, pH and brain temperat ure in patients with brain injuries and the clinical significanc e

Institute of Scientific and Technical Information of China (English)

无

2001-01-01

Objective:　To explore the regulation of early br ain tissue metabolic changing after brain injuries and the clinical significance . 　　Methods:　There were 17 patients with brain injuries. Early dire ct monitoring of PtiO2, PtiCO2, pH and brain temperature, dynami c observation of the relation between various parameters and clinics after brai n injuries were performed. 　　Results:　Early changes of PtiO2, PtiCO2 and pH we re closely correlated with outcome. The death rate obviously increased when P tiO2 was continuously lower than 9 mm?Hg within 24 hours after injuries. Secondary brain injury prolonged and aggravated brain tissue metabolic disturban ce. When intracerebral pressure was over 30 mm?Hg PtiO2 began to de crea se. The brain temperature in brain death patients was evidently lower than axill ary temperature. 　　Conclusions:　The direct monitoring of PtiO2, PtiC O2, pH and brain temperature is safe and accurate and can find early anoxia da mage to brain tissue and provide reliable basis for clinical therapy. It ha s an instructive significance in selecting and studying a new treatment method i n brain injuries. And it can be taken as a criterion in clinical judging brain d eaths.

On the slow diffusion of Point of Care systems in Therapeutic Drug Monitoring

Directory of Open Access Journals (Sweden)

Barbara eSanavio

2015-02-01

Full Text Available Recent advancements in point-of-care technologies show great transformative promises for personalized preventative and predictive medicine. However, fields like therapeutic drug monitoring, that first allowed for personalized treatment of patient’ disease, still lag behind in the widespread application of point-of-care devices for monitoring of patients. Surprisingly, very few applications in commonly monitored drugs, such as anti-epileptics, are paving the way for a point of care (PoC approach to patient’ therapy monitoring, compared to other fields –like intensive care cardiac markers monitoring, glycemic controls in diabetes, or bench-top hematological parameters analysis at the local drug store. Such delay in the development of portable fast clinically effective drug monitoring devices is in our opinion due more to an inertial drag on the pervasiveness of these new devices into the clinical field than a lack of technical capability. At the same time, some very promising technologies failed in the clinical practice for inadequate understanding of the outcome parameters necessary for a relevant technological breakthrough that has superior clinical performance. We hope, by overviewing both therapeutic drug monitoring practice and its yet unmet needs and latest advancement in micro and nanotechnology applications to PoC clinical devices, to help bridging the two communities, the one exploiting analytical technologies and the one mastering the most advanced techniques, into translating existing and forthcoming technologies in effective devices.

MR-monitored LITT as a palliative concept in patients with high grade gliomas: preliminary clinical experience.

Science.gov (United States)

Reimer, P; Bremer, C; Horch, C; Morgenroth, C; Allkemper, T; Schuierer, G

1998-01-01

The purpose of this study was to evaluate the clinical utility of laser-induced thermotherapy (LITT) as a palliative treatment for patients with high-grade gliomas. Four consenting patients with recurrent high grade III/IV gliomas near the primary language or motor areas were palliatively treated with LITT (2-5 W, 3-13 minutes; Neodym YAG Laser, Dornier, Friedrichshafen, Germany). Temperature monitoring was performed by T1-weighted turbo-fast low-angle shot (FLASH) imaging at 1.5 T (Siemens Magnetom SP 4000, Siemens, Erlangen, Germany). MRI studies before LITT included contrast-enhanced conventional scans and functional activation studies to localize the primary motor cortex or language areas using an echo-planar imaging (EPI) spin-echo (SE) sequence. Follow-up studies consisted of contrast-enhanced conventional scans as well as diffusion studies (contrast-enhanced Fourier-acquired steady-state technique and EPI-SE) and perfusion studies (EPI-SE with .2 mmol of gadolinium (Gd)/kg body weight) to differentiate post-therapeutic effects from residual or recurrent tumor growth. Local tumor control was achieved in areas with laser energy deposition with clinically stable conditions > or = 6 months. Conventional contrast-enhanced scans demonstrated strong enhancement surrounding ablated tumor components, which showed a reduction in CBV/CBF. Perfusion studies were useful to discriminate granulomatous tissue enhancement from residual or recurrent tumor growth. Careful application of LITT may evolve as an alternative palliative concept for patients with end-stage high-grade cerebral gliomas reducing clinical symptoms from circumscribed areas of pathology.

Sympathetic overactivity and arrhythmias in tetanus: electrocardiographic analysis Hiperatividade simpática e arritmias no tétano: análise eletrocardiográfica

Directory of Open Access Journals (Sweden)

Gustavo Trindade Henriques Filho

2007-02-01

Full Text Available As a result of the advances in the control of pulmonary insufficiency in tetanus, the cardiovascular system has increasingly been shown to be a determining factor in morbidity and mortality but detailed knowledge of the cardiovascular complications in tetanus is scanty. The 24h-Holter was carried out in order to detect arrhythmias and sympathetic overactivity in 38 tetanus patients admitted to an ICU. The SDNN Index (standard deviation from the normal R-to-R intervals, was useful in detecting adrenergic tonus, and ranged from 64.1 ± 27 in the more severe forms of tetanus to 125 ± 69 in the milder ones. Sympathetic overactivity occurred in 86.2% of the more severe forms of the disease, but was also detected in 33% of the milder forms. Half the patients had their sympathetic overactivity detected only by the Holter. The most frequent arrhythmias were isolated supraventricular (55.2% and ventricular (39.4% extrasystoles. There was no association of the arrhythmias with the clinical form of tetanus or with the presence of sympathetic overactivity. The present study demonstrated that major cardiovascular dysfunction, particularly sympathetic overactivity, occurs in all forms of tetanus, even in the milder ones. This has not been effectively detected with traditional monitoring in ICU and may not be properly treated.Com os avanços no controle da insuficiência respiratória no tétano, o sistema cardiovascular tem participado de forma crescente na morbidade e mortalidade da doença, mas o conhecimento dessas complicações é escasso. No intuito de detectar arritmias e hiperatividade simpática, o holter de 24 h foi utilizado em 38 pacientes com tétano admitidos numa UTI de doenças infecciosas. O índice SDNN (desvio standard dos intervalos normais R-a-R, foi útil na detecção do tônus adrenérgico, e variou de 64,1 ± 27 nas formas mais severas de tétano a 125 ± 69 nas formas mais leves. Hiperatividade simpática ocorreu em 86,2% das formas

A passive acoustic monitor of treatment effectiveness during extracorporeal lithotripsy

International Nuclear Information System (INIS)

Fedele, F; Coleman, A J; Thomas, K; Ryves, S; Phillips, D; Leighton, T G

2011-01-01

Although extracorporeal shockwave lithotripsy (ESWL) has now been in the clinic for at least three decades, there has been little advance in efforts (i) to estimate the efficacy of the treatment whilst it is in progress, or (ii) to determine the end-point of a treatment session in terms of the degree of stone fragmentation achieved. Previous in vitro experimentation and clinical trials have shown that a passive acoustic monitor has the potential to provide evidence of the effectiveness and end-point of lithotripsy. The system exploits secondary emissions generated during shock-tissue interaction, whose features depend on the quality of tissue at the beam focus. This prototype was developed into the first commercially available clinical ESWL treatment monitor (Precision Acoustic Ltd, Dorchester, UK), and a unit has been acquired and tested in the clinical routine by urologists at Guy's and St Thomas NHS Trust in March 2009. This paper critically assesses the performance of the new system for the first 25 treatments monitored. The ESWL monitor correctly predicted the treatment outcome of 15 of the 18 treatments that were followed-up clinically. In addition, it was noted that the measure of treatment effectiveness provided by the monitor after 500 shocks was predictive of the final treatment outcome (p < 0.001). This suggests that the system could be used in pre-assessment; indicating if the stone is susceptible to ESWL or if the patient should be sent for surgery.

A passive acoustic monitor of treatment effectiveness during extracorporeal lithotripsy

Energy Technology Data Exchange (ETDEWEB)

Fedele, F; Coleman, A J [Medical Physics Department, Guy' s and St Thomas NHS Foundation Trust, Westminster Bridge Road, SE1 7EH, London (United Kingdom); Thomas, K; Ryves, S; Phillips, D [Urology Department, Guy' s and St Thomas NHS Foundation Trust, Great Maze Pond, SE1 9RT, London (United Kingdom); Leighton, T G, E-mail: fiammetta.fedele@gstt.nhs.uk [Institute of Sound and Vibration Research, University of Southampton, Highfield, S017 1BJ, Southampton (United Kingdom)

2011-02-01

Although extracorporeal shockwave lithotripsy (ESWL) has now been in the clinic for at least three decades, there has been little advance in efforts (i) to estimate the efficacy of the treatment whilst it is in progress, or (ii) to determine the end-point of a treatment session in terms of the degree of stone fragmentation achieved. Previous in vitro experimentation and clinical trials have shown that a passive acoustic monitor has the potential to provide evidence of the effectiveness and end-point of lithotripsy. The system exploits secondary emissions generated during shock-tissue interaction, whose features depend on the quality of tissue at the beam focus. This prototype was developed into the first commercially available clinical ESWL treatment monitor (Precision Acoustic Ltd, Dorchester, UK), and a unit has been acquired and tested in the clinical routine by urologists at Guy's and St Thomas NHS Trust in March 2009. This paper critically assesses the performance of the new system for the first 25 treatments monitored. The ESWL monitor correctly predicted the treatment outcome of 15 of the 18 treatments that were followed-up clinically. In addition, it was noted that the measure of treatment effectiveness provided by the monitor after 500 shocks was predictive of the final treatment outcome (p < 0.001). This suggests that the system could be used in pre-assessment; indicating if the stone is susceptible to ESWL or if the patient should be sent for surgery.

A passive acoustic monitor of treatment effectiveness during extracorporeal lithotripsy

Energy Technology Data Exchange (ETDEWEB)

Fedele, F; Coleman, A J [Medical Physics Department, Guy' s and St Thomas NHS Foundation Trust, Westminster Bridge Road, SE1 7EH, London (United Kingdom); Thomas, K; Ryves, S; Phillips, D [Urology Department, Guy' s and St Thomas NHS Foundation Trust, Great Maze Pond, SE1 9RT, London (United Kingdom); Leighton, T G, E-mail: fiammetta.fedele@gstt.nhs.uk [Institute of Sound and Vibration Research, University of Southampton, Highfield, S017 1BJ, Southampton (United Kingdom)

2011-02-01

Although extracorporeal shockwave lithotripsy (ESWL) has now been in the clinic for at least three decades, there has been little advance in efforts (i) to estimate the efficacy of the treatment whilst it is in progress, or (ii) to determine the end-point of a treatment session in terms of the degree of stone fragmentation achieved. Previous in vitro experimentation and clinical trials have shown that a passive acoustic monitor has the potential to provide evidence of the effectiveness and end-point of lithotripsy. The system exploits secondary emissions generated during shock-tissue interaction, whose features depend on the quality of tissue at the beam focus. This prototype was developed into the first commercially available clinical ESWL treatment monitor (Precision Acoustic Ltd, Dorchester, UK), and a unit has been acquired and tested in the clinical routine by urologists at Guy's and St Thomas NHS Trust in March 2009. This paper critically assesses the performance of the new system for the first 25 treatments monitored. The ESWL monitor correctly predicted the treatment outcome of 15 of the 18 treatments that were followed-up clinically. In addition, it was noted that the measure of treatment effectiveness provided by the monitor after 500 shocks was predictive of the final treatment outcome (p < 0.001). This suggests that the system could be used in pre-assessment; indicating if the stone is susceptible to ESWL or if the patient should be sent for surgery.

Investigation progress of imaging techniques monitoring stem cell therapy

International Nuclear Information System (INIS)

Wu Jun; An Rui

2006-01-01

Recently stem cell therapy has showed potential clinical application in diabetes mellitus, cardiovascular diseases, malignant tumor and trauma. Efficient techniques of non-invasively monitoring stem cell transplants will accelerate the development of stem cell therapies. This paper briefly reviews the clinical practice of stem cell, in addition, makes a review of monitoring methods including magnetic resonance and radionuclide imaging which have been used in stem cell therapy. (authors)

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

Science.gov (United States)

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

[Advances of portable electrocardiogram monitor design].

Science.gov (United States)

Ding, Shenping; Wang, Yinghai; Wu, Weirong; Deng, Lingli; Lu, Jidong

2014-06-01

Portable electrocardiogram monitor is an important equipment in the clinical diagnosis of cardiovascular diseases due to its portable, real-time features. It has a broad application and development prospects in China. In the present review, previous researches on the portable electrocardiogram monitors have been arranged, analyzed and summarized. According to the characteristics of the electrocardiogram (ECG), this paper discusses the ergonomic design of the portable electrocardiogram monitor, including hardware and software. The circuit components and software modules were parsed from the ECG features and system functions. Finally, the development trend and reference are provided for the portable electrocardiogram monitors and for the subsequent research and product design.

Clinical application of 99mTc-HYNIC-TOC SPECT/CT in diagnosing and monitoring of pancreatic neuroendocrine neoplasms.

Science.gov (United States)

Xu, Junyan; Li, Yi; Xu, Xiaoping; Zhang, Jiangang; Zhang, Yingjian; Yu, Xianjun; Huang, Dan

2018-06-20

Our aim of this research was to determine the value of SPECT/CT with 99m Tc-HYNIC-TOC for evaluation of the pancreatic masses which were suspected as neuroendocrine neoplasms and follow-up of patients with pancreatic neuroendocrine neoplasms. We retrospectively analyzed 184 patients who performed 99m Tc-HYNIC-TOC SPECT/CT. All the patients were divided into two groups: one for assessment of diagnostic efficiency for pancreatic suspected masses (n = 140) and another for monitoring recurrence after surgery (n = 44). The image findings acquired at 2 h postinjection were compared to final diagnoses from pathological results and clinical follow-up. Then, the correlation between ratios of tumor-to-background (TBR) and tumor grade was analyzed. In group 1, 95/140 (67.9%) patients were confirmed as neuroendocrine neoplasms including 85 neuroendocrine tumors and 10 neuroendocrine carcinomas. Patient-based analysis showed that the sensitivity, specificity and accuracy of diagnosing neuroendocrine neoplasms with SPECT/CT were 81.1, 84.4 and 82.1%. There was significant difference of TBRs among G1, G2 and G3 (F = 3.175, P = 0.048). In group 2, 22/44 (50.0%) patients occurred metastasis mainly in liver. The sensitivity, specificity and accuracy of monitoring recurrence were 87.0, 100 and 93.2%. 99m Tc-HYNIC-TOC SPECT/CT is a reliable method of diagnosing and monitoring of pancreatic neuroendocrine neoplasms, especially neuroendocrine tumors.

Film-Screen Mammography versus digital storage plate mammography: Hard copy and monitor display of microcalcifications and focal findings - A retrospective clinical and histologic analysis

International Nuclear Information System (INIS)

Schulz-Wendtland, R.; Wenkel, E.; Aichinger, U.; Tartsch, M.; Kuchar, I.; Bautz, W.

2003-01-01

Purpose: A retrospective clinical-histological study to determine the diagnostic accuracy of mammography using conventional screen-film cassettes (hard copy), high-resolution digital phosphor storage plates (hard copy) and monitor display (soft copy) for microcalcifications and focal lesions (BI-RADS TM category 4 or 5). Materials and methods: From April to November 2001, 76 patients underwent conventional film-screen mammography and, after diagnosis and preoperative wire localization, digital mammography with the same exposure parameters. Five investigators retrospectively determined the diagnosis after the operation from randomly distributed mediolateral views (hard-copy reading) and from the monitor display (soft-copy reading). These results were correlated with the final histology. Results: The accuracy of conventional screen-film mammography, digital mammography and monitor-displayed mammography was 67%, 65% and 68% for all findings, (n = 76), 59%, 59% and 68% for microcalcifications (n = 44) and 75%, 72% and 63% for focal lesions (n = 32). The overall results showed no difference. Conclusions: Our findings indicate equivalence of conventional screen-film mammography, high-resolution digital phosphor storage plate mammography and monitor-displayed mammography. (orig.) [de

Medical application and clinical validation for reliable and trustworthy physiological monitoring using functional textiles: experience from the HeartCycle and MyHeart project.

Science.gov (United States)

Reiter, Harald; Muehlsteff, Jens; Sipilä, Auli

2011-01-01

Functional textiles are seen as promising technology to enable healthcare services and medical care outside hospitals due to their ability to integrate textile-based sensing and monitoring technologies into the daily life. In the past much effort has been spent onto basic functional textile research already showing that reliable monitoring solutions can be realized. The challenge remains to find and develop suited medical application and to fulfil the boundary conditions for medical endorsement and exploitation. The HeartCycle vest described in this abstract will serve as an example for a functional textile carefully developed according to the requirements of a specific medical application, its clinical validation, the related certification aspects and the next improvement steps towards exploitation.

Electrostatic discharges and their effect on the validity of registered values in intracranial pressure monitors

DEFF Research Database (Denmark)

Andresen, Morten; Thomsen, Ole Cornelius; Juhler, Marianne

2013-01-01

Object Intracranial pressure (ICP) monitoring is used extensively in clinical practice, and as such, the accuracy of registered ICP values is paramount. Clinical observations of nonphysiological changes in ICP have called into question the accuracy of registered ICP values. Subsequently, the auth......Object Intracranial pressure (ICP) monitoring is used extensively in clinical practice, and as such, the accuracy of registered ICP values is paramount. Clinical observations of nonphysiological changes in ICP have called into question the accuracy of registered ICP values. Subsequently......, the authors have tried to determine if the ICP monitors from major manufacturers were affected by electrostatic discharges (ESDs), if the changes were permanent or transient in nature, and if the changes were modified by the addition of different electrical appliances normally used in the neurointensive care....... Results Five pressure monitors from 4 manufacturers were evaluated. Three monitors containing electrical circuitry at the tip of the transducer were all affected by ESDs. Clinically significant permanent changes in the reported ICP values for 1 pressure monitor were observed, as well as temporary...

Intraoperative cranial nerve monitoring.

Science.gov (United States)

Harper, C Michel

2004-03-01

The purpose of intraoperative monitoring is to preserve function and prevent injury to the nervous system at a time when clinical examination is not possible. Cranial nerves are delicate structures and are susceptible to damage by mechanical trauma or ischemia during intracranial and extracranial surgery. A number of reliable electrodiagnostic techniques, including nerve conduction studies, electromyography, and the recording of evoked potentials have been adapted to the study of cranial nerve function during surgery. A growing body of evidence supports the utility of intraoperative monitoring of cranial nerve nerves during selected surgical procedures.

Environmental monitoring for krypton-85

International Nuclear Information System (INIS)

Barber, D.E.

1973-01-01

85 Kr presents unique environmental monitoring problems because it does not react with other elements and compounds at normal ambient temperatures and pressures. However, elaborate means are available to manage the 85 Kr problem, but a simpler, inexpensive approach is required if monitoring is to be accomplished at many sampling locations. This work shows that environmental monitoring for 85 Kr is possible by collecting air samples in thin plastic bags, and counting the bags for beta particle activity. The direct counting of contained samples of this type makes it possible to detect concentrations less than the public MPC for 85 Kr. The bagged-sample technique is readily adaptable to any environmental monitoring station with power to run a low-volume air pump. The idea of counting the bagged-sample directly is a new, low-cost, approach to environmental gas monitoring which may have application in environmental, clinical, and industrial situations

Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial.

Science.gov (United States)

Hirshberg, Adi; Downes, Katheryne; Srinivas, Sindhu

2018-04-27

Monitoring blood pressure at 72 hours and 7-10 days post partum in women with hypertensive disorders is recommended to decrease morbidity. However, there are no recommendations as to how to achieve this. To compare the effectiveness of text-based blood pressure monitoring to in-person visits for women with hypertensive disorders of pregnancy in the immediate postpartum period. Randomised clinical trial among 206 postpartum women with pregnancy-related hypertension diagnosed during the delivery admission between August 2016 and January 2017. Women were randomised to 2 weeks of text-based surveillance using a home blood pressure cuff and previously tested automated platform or usual care blood pressure check at their prenatal clinic 4-6 days following discharge. The primary study outcome was a single recorded blood pressure in the first 10 days post partum. The ability to meet American Congress of Obstetricians and Gynecologists (ACOG) guidelines, defined as having a blood pressure recorded on postpartum days 3-4 and 7-10 was evaluated in the text message group. The study was powered to detect a 1.4-fold increase in a single recorded blood pressure using text messaging. All outcomes were analysed as intention to treat. 206 women were randomised (103 in each arm). Baseline characteristics were similar. There was a statistically significant increase in a single blood pressure obtained in the texting group in the first 10 days post partum as compared with the office group (92.2% vs 43.7%; adjusted OR 58.2 (16.2-208.1), p<0.001). Eighty-four per cent of patients undergoing text-based surveillance met ACOG criteria for blood pressures at both recommended points. Text-based monitoring is more effective in obtaining blood pressures and meeting current clinical guidelines in the immediate postdischarge period in women with pregnancy-related hypertension compared with traditional office-based follow-up. NCT03185455, Remote Surveillance of Postpartum Hypertension (Text

Clinical Trials

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Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...

Clinical Trials

Medline Plus

Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

Clinical evaluation of monitor unit software and the application of action levels

International Nuclear Information System (INIS)

Georg, Dietmar; Nyholm, Tufve; Olofsson, Joergen; Kjaer-Kristoffersen, Flemming; Schnekenburger, Bruno; Winkler, Peter; Nystroem, Hakan; Ahnesjoe, Anders; Karlsson, Mikael

2007-01-01

Purpose: The aim of this study was the clinical evaluation of an independent dose and monitor unit verification (MUV) software which is based on sophisticated semi-analytical modelling. The software was developed within the framework of an ESTRO project. Finally, consistent handling of dose calculation deviations applying individual action levels is discussed. Materials and methods: A Matlab-based software ('MUV') was distributed to five well-established treatment centres in Europe (Vienna, Graz, Basel, Copenhagen, and Umea) and evaluated as a quality assurance (QA) tool in clinical routine. Results were acquired for 226 individual treatment plans including a total of 815 radiation fields. About 150 beam verification measurements were performed for a portion of the individual treatment plans, mainly with time variable fluence patterns. The deviations between dose calculations performed with a treatment planning system (TPS) and the MUV software were scored with respect to treatment area, treatment technique, geometrical depth, radiological depth, etc. Results: In general good agreement was found between calculations performed with the different TPSs and MUV, with a mean deviation per field of 0.2 ± 3.5% (1 SD) and mean deviations of 0.2 ± 2.2% for composite treatment plans. For pelvic treatments less than 10% of all fields showed deviations larger than 3%. In general, when using the radiological depth for verification calculations the results and the spread in the results improved significantly, especially for head-and-neck and for thorax treatments. For IMRT head-and-neck beams, mean deviations between MUV and the local TPS were -1.0 ± 7.3% for dynamic, and -1.3 ± 3.2% for step-and-shoot IMRT delivery. For dynamic IMRT beams in the pelvis good agreement was obtained between MUV and the local TPS (mean: -1.6 ± 1.5%). Treatment site and treatment technique dependent action levels between ±3% and ±5% seem to be clinically realistic if a radiological depth

Comprehensive in-hospital monitoring in acute heart failure: applications for clinical practice and future directions for research. A statement from the Acute Heart Failure Committee of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).

Science.gov (United States)

Harjola, Veli-Pekka; Parissis, John; Brunner-La Rocca, Hans-Peter; Čelutkienė, Jelena; Chioncel, Ovidiu; Collins, Sean P; De Backer, Daniel; Filippatos, Gerasimos S; Gayat, Etienne; Hill, Loreena; Lainscak, Mitja; Lassus, Johan; Masip, Josep; Mebazaa, Alexandre; Miró, Òscar; Mortara, Andrea; Mueller, Christian; Mullens, Wilfried; Nieminen, Markku S; Rudiger, Alain; Ruschitzka, Frank; Seferovic, Petar M; Sionis, Alessandro; Vieillard-Baron, Antoine; Weinstein, Jean Marc; de Boer, Rudolf A; Crespo Leiro, Maria G; Piepoli, Massimo; Riley, Jillian P

2018-04-30

This paper provides a practical clinical application of guideline recommendations relating to the inpatient monitoring of patients with acute heart failure, through the evaluation of various clinical, biomarker, imaging, invasive and non-invasive approaches. Comprehensive inpatient monitoring is crucial to the optimal management of acute heart failure patients. The European Society of Cardiology heart failure guidelines provide recommendations for the inpatient monitoring of acute heart failure, but the level of evidence underpinning most recommendations is limited. Many tools are available for the in-hospital monitoring of patients with acute heart failure, and each plays a role at various points throughout the patient's treatment course, including the emergency department, intensive care or coronary care unit, and the general ward. Clinical judgment is the preeminent factor guiding application of inpatient monitoring tools, as the various techniques have different patient population targets. When applied appropriately, these techniques enable decision making. However, there is limited evidence demonstrating that implementation of these tools improves patient outcome. Research priorities are identified to address these gaps in evidence. Future research initiatives should aim to identify the optimal in-hospital monitoring strategies that decrease morbidity and prolong survival in patients with acute heart failure. © 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.

Blood pressure monitoring: theory and practice. European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability Teaching Course Proceedings.

Science.gov (United States)

Stergiou, George S; Palatini, Paolo; Asmar, Roland; Bilo, Grzegorz; de la Sierra, Alejandro; Head, Geoff; Kario, Kazuomi; Mihailidou, Anastasia; Wang, Jiguang; Mancia, Giuseppe; O'Brien, Eoin; Parati, Gianfranco

2018-02-01

The European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and Cardiovascular Variability organized a Teaching Course on 'Blood Pressure Monitoring: Theory and Practice' during the 2017 ESH Meeting in Milan, Italy. This course performed by 11 international BP monitoring experts covered key topics of BP monitoring, including office BP measurement, ambulatory BP monitoring, home BP monitoring, ambulatory versus home BP, white-coat and masked hypertension, cuff use, and BP variability. This article presents a summary of the proceedings of the ESH BP Monitoring Teaching Course, including essential information, practical issues, and recommendations on the clinical application of BP monitoring methods, aiming to the optimal management of patients with suspected or diagnosed hypertension.

Workup and management of patients with frequent premature ventricular contractions.

Science.gov (United States)

Giles, Katie; Green, Martin S

2013-11-01

Premature ventricular contractions (PVCs) are a frequently encountered entity in clinical cardiology. They rarely affect prognosis or management. However, they might produce bothersome symptoms and, in select individuals with a high PVC burden, they might contribute to left ventricular (LV) dysfunction. Workup of patients with very frequent PVCs consists of a thorough history and physical examination to screen for underlying cardiac disease and potential triggers. Routine investigations include a standard 12-lead electrocardiogram, as well as an echocardiogram. A Holter monitor should be performed in those with severe symptoms, a history of syncope, or a malignant family history. Exercise stress testing has a role in evaluating for ischemia and in the assessment of patients with exertional symptoms. More advanced testing is not warranted if these initial investigations are reassuring. Referral to an arrhythmia specialist should be considered in patients with LV dysfunction whose PVC burden exceeds 15%. Frequent ventricular ectopy represents a rare, but reversible cause of LV dysfunction and these patients should be further evaluated for possible catheter ablation. Copyright © 2013 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Monitoring and Management of Toxicities of Novel B Cell Signaling Agents.

Science.gov (United States)

Rhodes, Joanna; Mato, Anthony; Sharman, Jeff P

2018-04-11

B cell signaling agents, including ibrutinib, idelalisib, and the BCL-2 inhibitor venetoclax have become an integral part of therapy for patients with non-Hodgkin's lymphomas. The toxicity profiles of these medications is distinct from chemoimmunotherapy. Here, we will review the mechanism of action of these drugs, their efficacy, and toxicity management. Ibrutinib use is associated with increased risk of atrial fibrillation and bleeding which can be managed using dose interruptions and modifications. Patients on idelalisib require close clinical and frequent laboratory monitoring, particularly of liver function tests to ensure there are no serious adverse events. Monitoring for infections is important in patients on both idelalisib and ibrutinib. Venetoclax requires close clinical and laboratory monitoring to prevent significant tumor lysis. Targeted B cell receptor therapies each have unique side effect profiles which require careful clinical monitoring. As we continue to use these therapies, optimal management strategies will continue to be elucidated.

Self-monitoring of blood glucose in diabetes mellitus: arguments for an individualized approach.

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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.

Clinical utility of therapeutic drug monitoring in biological disease modifying anti-rheumatic drug treatment of rheumatic disorders: a systematic narrative review.

Science.gov (United States)

Van Herwaarden, Noortje; Van Den Bemt, Bart J F; Wientjes, Maike H M; Kramers, Cornelis; Den Broeder, Alfons A

2017-08-01

Biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) have improved the treatment outcomes of inflammatory rheumatic diseases including Rheumatoid Arthritis and spondyloarthropathies. Inter-individual variation exists in (maintenance of) response to bDMARDs. Therapeutic Drug Monitoring (TDM) of bDMARDs could potentially help in optimizing treatment for the individual patient. Areas covered: Evidence of clinical utility of TDM in bDMARD treatment is reviewed. Different clinical scenarios will be discussed, including: prediction of response after start of treatment, prediction of response to a next bDMARD in case of treatment failure of the first, prediction of successful dose reduction or discontinuation in case of low disease activity, prediction of response to dose-escalation in case of active disease and prediction of response to bDMARD in case of flare in disease activity. Expert opinion: The limited available evidence does often not report important outcomes for diagnostic studies, such as sensitivity and specificity. In most clinical relevant scenarios, predictive value of serum (anti-) drug levels is absent, therefore the use of TDM of bDMARDs cannot be advocated. Well-designed prospective studies should be done to further investigate the promising scenarios to determine the place of TDM in clinical practice.

Clinical application of maternal serum HPL and INS levels determination for fetal health monitoring during perinatal period

International Nuclear Information System (INIS)

Xiang Xu; Tian Ying; Li Baoping; Luo Pengxiang; Wang Hong; Zhang Su'e; Chen Qiaozhi; Wang Xiaohua

2007-01-01

Objective: To investigate the possible applicability of maternal serum human placental lactogen (HPL) and insulin levels determination for fetal health monitoring. Methods: Maternal serum HPL and insulin levels were determined with RIA in (1) 70 pregnant women clinically diagnosed as with gestational diabetes (2) 66 pregnant women with hypertension and (3) 110 normal pregnant women as controls. Results: Serum HPL and insulin levels in the women with gestational diabetes were significantly higher than those in the controls (P 0.05). Conclusion: Detection of abnormally high or low levels of serum HPL and insulin in pregnant women suggested presence of maternal diseases which might affect fetal development (over weight or growth restriction). This approach was much more sensitive than conventional sonographic examination of fetus. (authors)

Routine intracranial pressure monitoring in acute coma.

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Forsyth, Rob J; Raper, Joseph; Todhunter, Emma

2015-11-02

We know that the brain damage resulting from traumatic and other insults is not due solely to the direct consequences of the primary injury. A significant and potentially preventable contribution to the overall morbidity arises from secondary hypoxic-ischaemic damage. Brain swelling accompanied by raised intracranial pressure (ICP) prevents adequate cerebral perfusion with well-oxygenated blood.Detection of raised ICP could be useful in alerting clinicians to the need to improve cerebral perfusion, with consequent reductions in brain injury. To determine whether routine ICP monitoring in severe coma of any cause reduces the risk of all-cause mortality or severe disability at final follow-up. We searched the Cochrane Injuries Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL Plus, ISI Web of Science (SCI-EXPANDED & CPCI-S), clinical trials registries and reference lists. We ran the most recent search on 22 May 2015. All randomised controlled studies of real-time ICP monitoring by invasive or semi-invasive means in acute coma (traumatic or non-traumatic aetiology) versus clinical care without ICP monitoring (that is, guided only by clinical or radiological inference of the presence of raised ICP). Two authors (ET and RF) worked independently to identify the one study that met inclusion criteria. JR and RF independently extracted data and assessed risk of bias. We contacted study authors for additional information, including details of methods and outcome data. One randomized controlled trial (RCT) meeting the selection criteria has been identified to date.The included study had 324 participants. We judged risk of bias to be low for all categories except blinding of participants and personnel, which is not feasible for this intervention. There were few missing data, and we analysed all on an intention-to-treat basis.Participants could be 13 years of age or older (mean age of sample 29

Telemetric implantable pressure sensor for short- and long-term monitoring of intracranial pressure.

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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.

Evaluating clinical accuracy of continuous glucose monitoring devices: other methods

NARCIS (Netherlands)

Wentholt, Iris M. E.; Hart, August A.; Hoekstra, Joost B. L.; DeVries, J. Hans

2008-01-01

With more and more continuous glucose monitoring devices entering the market, the importance of adequate accuracy assessment grows. This review discusses pros and cons of Regression Analysis and Correlation Coefficient, Relative Difference measures, Bland Altman plot, ISO criteria, combined curve

Serumferritin - diagnostic relevance and clinical usefulness

Energy Technology Data Exchange (ETDEWEB)

Linkesch, W [Vienna Univ. (Austria). 2. Medizinische Klinik

1984-01-01

The introduction of a WHO Standard for serumferritin effected a standardisation of different methods, improving quality and security for clinical routine diagnostic purposes. Therefore the clinical evaluation of serumferritin gained even more importance. For evaluation of iron stores of children, pregnant women, population studies, patients on hemodialysis or patients with rheumatoid arthritis low serumferritin values give safe results. In addition serumferritin is of clinical usefulness in monitoring therapy of both iron deficiency and iron overload. Evaluating a single serumferritin value one should consider the total clinical situation of the patient. As some tumors can produce and secrete serumferritin, e.g. acute myeloblastic leukemia, germ cell tumors, malignant melanoma, serumferritin might be helpful in monitoring the malignant disease. The ongoing characterization of tissue isoferritin, especially acidic isoferritin, may eventually lead to a clinically significant diagnostic marker of neoplasia.

Serumferritin - diagnostic relevance and clinical usefulness

International Nuclear Information System (INIS)

Linkesch, W.

1984-01-01

The introduction of a WHO Standard for serumferritin effected a standardisation of different methods, improving quality and security for clinical routine diagnostic purposes. Therefore the clinical evaluation of serumferritin gained even more importance. For evaluation of iron stores of children, pregnant women, population studies, patients on hemodialysis or patients with rheumatoid arthritis low serumferritin values give safe results. In addition serumferritin is of clinical usefulness in monitoring therapy of both iron deficiency and iron overload. Evaluating a single serumferritin value on should consider the total clinical situation of the patient. As some tumors can produce and secrete serumferritin, e. g. acute myeloblastic leukemia, germ cell tumors, malignant melanoma, serumferritin might be helpful in monitoring the malignant disease. The ongoing characterization of tissue isoferritin, especially acidic isoferritin, may eventually lead to a clinically significant diagnostic marker of neoplasia. (Author)

Arrhythmogenic right ventricular dysplasia: Atypical clinical presentation.

Science.gov (United States)

Marçalo, José; Menezes Falcão, Luiz

2017-03-01

A 67-year-old man was admitted to our hospital after episodes of syncope preceded by malaise and diffuse neck and chest discomfort. No family history of cardiac disease was reported. Laboratory workup was within normal limits, including D-dimers, serum troponin I and arterial blood gases. The electrocardiogram showed sinus rhythm with T-wave inversion in leads V1 to V3. Computed tomography angiography to investigate pulmonary embolism showed no abnormal findings. Transthoracic echocardiography (TTE) displayed massive enlargement of the right ventricle with intact interatrial septum and no pulmonary hypertension. Cardiac magnetic resonance imaging (MRI) confirmed right ventricular (RV) dilatation and revealed marked hypokinesia/akinesia of the lateral wall. Exercise stress testing was negative for ischemia. According to the 2010 Task Force criteria for arrhythmogenic right ventricular dysplasia (ARVD), this patient presented two major criteria (global or regional dysfunction and structural alterations: by MRI, regional RV akinesia or dyskinesia or dyssynchronous RV contraction and RV ejection fraction ≤40%, and repolarization abnormalities: inverted T waves in right precordial leads [V1, V2, and V3]); and one minor criterion (>500 ventricular extrasystoles per 24 hours by Holter), and so a diagnosis of ARVD was made. After electrophysiologic study (EPS) the patient received an implantable cardioverter-defibrillator (ICD). This late clinical presentation of ARVD highlights the importance of TTE screening, possibly complemented by MRI. The associated risk of sudden death was assessed by EPS leading to the implantation of an ICD. Genetic association studies should be offered to the offspring of all ARVD patients. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

Browser Based Platform in Maintaining Clinical Activities - Use of The iPads in Head and Neck Clinics

Science.gov (United States)

Yang, W. Y.; Moore, J.; Quon, H.; Evans, K.; Sharabi, A.; Herman, J.; Hacker-Prietz, A.; McNutt, T.

2014-03-01

Purpose: Incompatibility between documentation and clinical workflow causes physician resistance in organized data collection, which in turn complicates the use of data in patient care improvement. To resolve the gap, we developed an iPad compatible in situ browser-based platform that integrates clinical activity with data collection and analysis presentation. The ability to perform in-clinic activities and monitor decision making using the iPad was evaluated. Methods: A browser-based platform that can exchange and present analysed data from the MOSAIQ database was developed in situ, the iPads were distributed in head and neck clinics to present the browser for clinical activities, data collection and assessment monitoring. Performance of the iPads for in-clinic activities was observed. Results: All in-clinic documentation activities can be performed without workstation computers. Accessing patient record and previous assessments was significantly faster without having to open the MOSAIQ application. Patient assessments can be completed with the physician facing the patient. Graphical presentation of toxicity progression and patient radiation plans to the patient can be performed in single interface without patient leaving the seating area. Updates in patient treatment status and medical history were presented in real time without having to move paper charts around. Conclusions: The iPad can be used in clinical activities independent of computer workstations. Improvements in clinical workflow can be critical in reducing physician resistance in data maintenance. Using the iPad in providing real-time quality monitoring is intuitive to both providers and patients.

Cost-benefit and cost-savings analyses of antiarrhythmic medication monitoring.

Science.gov (United States)

Snider, Melissa; Carnes, Cynthia; Grover, Janel; Davis, Rich; Kalbfleisch, Steven

2012-09-15

The economic impact of pharmacist-managed antiarrhythmic drug therapy monitoring on an academic medical center's electrophysiology (EP) program was investigated. Data were collected for the initial two years of patient visits (n = 816) to a pharmacist-run clinic for antiarrhythmic drug therapy monitoring. A retrospective cost analysis was conducted to assess the direct costs associated with three appointment models: (1) a clinic office visit only, (2) a clinic visit involving electrocardiography and basic laboratory tests, and (3) a clinic visit including pulmonary function testing and chest x-rays in addition to electrocardiography and laboratory testing. A subset of patient cases (n = 18) were included in a crossover analysis comparing pharmacist clinic care and usual care in an EP physician clinic. The primary endpoints were the cost benefits and cost savings associated with pharmacy-clinic care versus usual care. A secondary endpoint was improvement of overall EP program efficiency. The payer mix was 61.6% (n = 498) Medicare, 33.2% (n = 268) managed care, and 5.2% (n = 42) other. Positive contribution margins were demonstrated for all appointment models. The pharmacist-managed clinic also yielded cost savings by reducing overall patient care charges by 21% relative to usual care. By the second year, the pharmacy clinic improved EP program efficiency by scheduling an average of 24 patients per week, in effect freeing up one day per week of EP physician time to spend on other clinical activities. Pharmacist monitoring of antiarrhythmic drug therapy in an out-patient clinic provided cost benefits, cost savings, and improved overall EP program efficiency.

Metabolic monitoring in New Zealand district health board mental health services.

Science.gov (United States)

Staveley, Aimee; Soosay, Ian; O'Brien, Anthony J

2017-11-10

To audit New Zealand district health boards' (DHBs) metabolic monitoring policies in relation to consumers prescribed second-generation antipsychotic medications using a best practice guideline. Metabolic monitoring policies from DHBs and one private clinic were analysed in relation to a best practice standard developed from the current literature and published guidelines relevant to metabolic syndrome. Fourteen of New Zealand's 20 DHBs currently have metabolic monitoring policies for consumers prescribed antipsychotic medication. Two of those policies are consistent with the literature-based guideline. Eight policies include actions to be taken when consumers meet criteria for metabolic syndrome. Four DHBs have systems for measuring their rates of metabolic monitoring. There is no consensus on who is clinically responsible for metabolic monitoring. Metabolic monitoring by mental health services in New Zealand reflects international experience that current levels of monitoring are low and policies are not always in place. Collaboration across the mental health and primary care sectors together with the adoption of a consensus guideline is needed to improve rates of monitoring and reduce current rates of physical health morbidities.

Are Changes in Heart Rate Variability During Hypoglycemia Confounded by the Presence of Cardiovascular Autonomic Neuropathy in Patients with Diabetes?

DEFF Research Database (Denmark)

Cichosz, Simon Lebech; Frystyk, Jan; Tarnow, Lise

2017-01-01

BACKGROUND: We have recently shown how the combination of information from continuous glucose monitor (CGM) and heart rate variability (HRV) measurements can be used to construct an algorithm for prediction of hypoglycemia in both bedbound and active patients with type 1 diabetes (T1D). Questions...... with CGM and a Holter device while they performed normal daily activities. CAN was diagnosed using two cardiac reflex tests: (1) deep breathing and (2) orthostatic hypotension and end organ symptoms. Early CAN was defined as the presence of one abnormal reflex test and severe CAN was defined as two...

[Clinical and monitoring experience of isotretinoin in Italy].

Science.gov (United States)

Cavicchini, S; Bottoni, A; Caputo, R

1989-01-01

We report the results of a multicentric evaluation on effectiveness and safety of isotretinoin in severe acne, recalcitrant to traditional treatments. 208 patients, suffering especially from cystic acne, have been enrolled in a post-marketing clinical trial in 11 Dermatological Italian Departments. The clinical effectiveness of isotretinoin has been very good in 77% of patients, good in 16% and sufficient in 4%. The tolerability of the drug was considered good in 90% of patients. Finally, isotretinoin might be considered as one of the most effective drugs in the therapy of severe forms of acne, resistant to usual treatment, and often affecting patients on the physical and psychological side.

Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study

Science.gov (United States)

Lee, Jie-Eun; Lee, Dong Hwa; Oh, Tae Jung; Kim, Kyoung Min; Choi, Sung Hee; Lim, Soo; Park, Young Joo; Park, Do Joon; Jang, Hak Chul

2018-01-01

Background Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrotoxicosis can be detected by currently available wearable activity trackers, there have been few trials of the clinical application of wearable devices in patients with thyrotoxicosis. Objective The aim of this study is to investigate the clinical applicability of wearable device-generated data to the management of thyrotoxicosis. We are analyzing continuously monitored data for heart rate, physical activity, and sleep in patients with thyrotoxicosis during their clinical course after treatment. Methods Thirty thyrotoxic patients and 10 control subjects were enrolled in this study at Seoul National University Bundang Hospital. Heart rate, physical activity, and sleep are being monitored using a Fitbit Charge HR or Fitbit Charge 2. Clinical data including anthropometric measures, thyroid function test, and hyperthyroidism symptom scale are recorded. Results Study enrollment began in December 2016, and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by September 2017. Conclusions This study will provide a foundational feasibility trial of the clinical applications of biosignal measurements to the differential diagnosis, prediction of clinical course, early detection of recurrence, and treatment in patients with thyrotoxicosis. Trial Registration ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2) PMID:29467121

Calmodulin 2 Mutation N98S Is Associated with Unexplained Cardiac Arrest in Infants Due to Low Clinical Penetrance Electrical Disorders.

Directory of Open Access Journals (Sweden)

Juan Jiménez-Jáimez

Full Text Available Calmodulin 1, 2 and 3 (CALM mutations have been found to cause cardiac arrest in children at a very early age. The underlying aetiology described is long QT syndrome (LQTS, catecholaminergic polymorphic ventricular tachycardia (CPVT and idiopathic ventricular fibrillation (IVF. Little phenotypical data about CALM2 mutations is available.The aim of this paper is to describe the clinical manifestations of the Asn98Ser mutation in CALM2 in two unrelated children in southern Spain with apparently unexplained cardiac arrest/death.Two unrelated children aged 4 and 7, who were born to healthy parents, were studied. Both presented with sudden cardiac arrest. The first was resuscitated after a VF episode, and the second died suddenly. In both cases the baseline QTc interval was within normal limits. Peripheral blood DNA was available to perform targeted gene sequencing.The surviving 4-year-old girl had a positive epinephrine test for LQTS, and polymorphic ventricular ectopic beats were seen on a previous 24-hour Holter recording from the deceased 7-year-old boy, suggestive of a possible underlying CPVT phenotype. A p.Asn98Ser mutation in CALM2 was detected in both cases. This affected a highly conserved across species residue, and the location in the protein was adjacent to critical calcium binding loops in the calmodulin carboxyl-terminal domain, predicting a high pathogenic effect.Human calmodulin 2 mutation p.Asn98Ser is associated with sudden cardiac death in childhood with a variable clinical penetrance. Our results provide new phenotypical information about clinical behaviour of this mutation.

Core Components for a Clinically Integrated mHealth App for Asthma Symptom Monitoring.

Science.gov (United States)

Rudin, Robert S; Fanta, Christopher H; Predmore, Zachary; Kron, Kevin; Edelen, Maria O; Landman, Adam B; Zimlichman, Eyal; Bates, David W

2017-10-01

Background mHealth apps may be useful tools for supporting chronic disease management. Objective Our aim was to apply user-centered design principles to efficiently identify core components for an mHealth-based asthma symptom–monitoring intervention using patient-reported outcomes (PROs). Methods We iteratively combined principles of qualitative research, user-centered design, and “gamification” to understand patients' and providers' needs, develop and refine intervention components, develop prototypes, and create a usable mobile app to integrate with clinical workflows. We identified anticipated benefits and burdens for stakeholders. Results We conducted 19 individual design sessions with nine adult patients and seven clinicians from an academic medical center (some were included multiple times). We identified four core intervention components: (1) Invitation—patients are invited by their physicians. (2) Symptom checks—patients receive weekly five-item questionnaires via the app with 48 hours to respond. Depending on symptoms, patients may be given the option to request a call from a nurse or receive one automatically. (3) Patient review—in the app, patients can view their self-reported data graphically. (4) In-person visit—physicians have access to patient-reported symptoms in the electronic health record (EHR) where they can review them before in-person visits. As there is currently no location in the EHR where physicians would consistently notice these data, recording a recent note was the best option. Benefits to patients may include helping decide when to call their provider and facilitating shared decision making. Benefits to providers may include saving time discussing symptoms. Provider organizations may need to pay nurses extra, but those costs may be offset by reduced visits and hospitalizations. Conclusion Recent systematic reviews show inconsistent outcomes and little insight into functionalities required for mHealth asthma

A case of delayed cardiac perforation of active ventricular lead

Directory of Open Access Journals (Sweden)

Hangyuan Guo

2011-12-01

Full Text Available A 65-year-old man was admitted as for one month of repetitive dizziness and one episode of syncope. Electrocardiogram showed sinus bradycardia and his Holter monitoring also showed sinus bradycardia with sinus arrest, sino-atrial block and a longest pause of 4.3 s. Then sick sinus syndrome and Adam-Stokes syndrome were diagnosed. Then a dual chamber pacemaker (Medtronic SDR303 was implanted and the parameters were normal by detection. The patient was discharged 1 week later with suture removed. Then 1.5 month late the patient was presented to hospital once again for sudden onset of chest pain with exacerbation after taking deep breath. Pacemaker programming showed both pacing and sensing abnormality with threshold of?5.0V and resistance of 1200?. Lead perforation was revealed by chest X-ray and confirmed by echocardiogram. Considering the fact that there was high risk to remove ventricular lead, spiral tip of previous ventricular lead was withdrew followed by implantation of a new ventricular active lead to the septum. Previous ventricular lead was maintained. As we know that the complications of lead perforation in the clinic was rare. Here we discuss the clinical management and the possible reasons for cardiac perforation of active ventricular lead.

Near Infrared Spectroscopy as a Hemodynamic Monitor in Critical Illness.

Science.gov (United States)

Ghanayem, Nancy S; Hoffman, George M

2016-08-01

The objectives of this review are to discuss the technology and clinical interpretation of near infrared spectroscopy oximetry and its clinical application in patients with congenital heart disease. MEDLINE and PubMed. Near infrared spectroscopy provides a continuous noninvasive assessment of tissue oxygenation. Over 20 years ago, near infrared spectroscopy was introduced into clinical practice for monitoring cerebral oxygenation during cardiopulmonary bypass in adults. Since that time, the utilization of near infrared spectroscopy has extended into the realm of pediatric cardiac surgery and is increasingly being used in the cardiac ICU to monitor tissue oxygenation perioperatively.

Remote patient monitoring in chronic heart failure.

Science.gov (United States)

Palaniswamy, Chandrasekar; Mishkin, Aaron; Aronow, Wilbert S; Kalra, Ankur; Frishman, William H

2013-01-01

Heart failure (HF) poses a significant economic burden on our health-care resources with very high readmission rates. Remote monitoring has a substantial potential to improve the management and outcome of patients with HF. Readmission for decompensated HF is often preceded by a stage of subclinical hemodynamic decompensation, where therapeutic interventions would prevent subsequent clinical decompensation and hospitalization. Various methods of remote patient monitoring include structured telephone support, advanced telemonitoring technologies, remote monitoring of patients with implanted cardiac devices such as pacemakers and defibrillators, and implantable hemodynamic monitors. Current data examining the efficacy of remote monitoring technologies in improving outcomes have shown inconsistent results. Various medicolegal and financial issues need to be addressed before widespread implementation of this exciting technology can take place.

Clinical review: Update on hemodynamic monitoring - a consensus of 16.

NARCIS (Netherlands)

Vincent, J.L.; Rhodes, A.; Perel, A.; Martin, G.S.; Rocca, G.D.; Vallet, B.; Pinsky, M.R.; Hofer, C.K.; Teboul, J.L.; Boode, W.P. de; Scolletta, S.; Viellard-Baron, A.; Backer, D. de; Walley, K.R.; Maggiorini, M.; Singer, M.

2011-01-01

Hemodynamic monitoring plays a fundamental role in the management of acutely ill patients. With increased concerns about the use of invasive techniques, notably the pulmonary artery catheter, to measure cardiac output, recent years have seen an influx of new, less-invasive means of measuring

Impaired self-monitoring of inner speech in schizophrenia patients with verbal hallucinations and in non-clinical individuals prone to hallucinations

Directory of Open Access Journals (Sweden)

Gildas Brébion

2016-09-01

Full Text Available Background: Previous research has shown that various memory errors reflecting failure in the self-monitoring of speech were associated with auditory/verbal hallucinations in schizophrenia patients and with proneness to hallucinations in non-clinical individuals. Method: We administered to 57 schizophrenia patients and 60 healthy participants a verbal memory task involving free recall and recognition of lists of words with different structures (high-frequency, low-frequency, and semantically-organisable words. Extra-list intrusions in free recall were tallied, and the response bias reflecting tendency to make false recognitions of non-presented words was computed for each list. Results: In the male patient subsample, extra-list intrusions were positively associated with verbal hallucinations and inversely associated with negative symptoms. In the healthy participants the extra-list intrusions were positively associated with proneness to hallucinations. A liberal response bias in the recognition of the high-frequency words was associated with verbal hallucinations in male patients and with proneness to hallucinations in healthy men. Meanwhile, a conservative response bias for these high-frequency words was associated with negative symptoms in male patients and with social anhedonia in healthy men. Conclusions: Misattribution of inner speech to an external source, reflected by false recollection of familiar material, seems to underlie both clinical and non-clinical hallucinations. Further, both clinical and non-clinical negative symptoms may exert on verbal memory errors an effect opposite to that of hallucinations.

Monitoring of patients in the Oncology department of the Clinical Hospital

International Nuclear Information System (INIS)

De Quiroz, J.

2010-01-01

An important number of patients that visit the Oncology department o the Clinicas Hospital lost sight at some stage of their evolution. Our objective was to quantify the proportion of patients who are lost and describe the time spent in the service and its relationship with variables such as age, sex, origin of the patient and progress of the disease, for which we performed a descriptive observational study with an analytical component of 435 stories clinics patients with confirmed diagnosis of cancer, treated from January 2001 to December 2004, in order to have a minimum of 5 years of follow-up potential. Data were processed with Excel 2003. Patients had between 15-85 years old with a mean and median of 52 ± 14 years DS. Two hundred Seventy women and 165 were men, 232 were from the metropolitan area. The time of length of service was 0-114 months with a median of 8 and an average DS 21 months ± 27 months. As of December 2009 31 117 patients had died 36 remained in control and 282 were lost from sight. We found no relationship between age (p = 0.1) nor the state of progress of the disease at diagnosis (p = 0.21) If there were significant differences with greater probability of loss tracking men (p = 0.009) and from sites outside the metropolitan area (p = 0.04). The number of patients who are lost is very large and we must develop strategies more effective monitoring

Evaluation of the photon monitor backscatter in medical electron accelerators

International Nuclear Information System (INIS)

Zrenner, M.; Krieger, H.

1999-01-01

Background: Modern linear accelerators permit the use of irregular fields due to their flexible collimator systems with separately movable jaws or multileaf collimators. When using such irregular fields in the clinical practice output factors have to be corrected for enhanced backscatter to the dose monitor as compared with the conventional block shieldings. Methods: A method is presented to detect the monitor backscatter contributions to the output factor for irregular field settings. Results: The monitor backscatter factors have been measured using a telescopic device for 2 different treatment head geometries (Varian Clinac 2100C/D, General Electric Saturne 15) and for 3 photon radiation qualities (nominal energies X6, X18, X12). A method is introduced to calculate the monitor backscatter for arbitrary irregular treatment fields from the experimental data for square or rectangular fields. Conclusions: Besides the corrections for changes in phantom scatter and changes in the aperture, corrections for monitor backscatter have to be taken into account in many clinical cases. They can contribute up to more than 10% compared with the monitor values for free regular fields. (orig.) [de

Carlos Chagas Discoveries as a Drop Back to Scientific Construction of Chronic Chagas Heart Disease.

Science.gov (United States)

Bestetti, Reinaldo B; Restini, Carolina Baraldi A; Couto, Lucélio B

2016-07-01

The scientific construction of chronic Chagas heart disease (CCHD) started in 1910 when Carlos Chagas highlighted the presence of cardiac arrhythmia during physical examination of patients with chronic Chagas disease, and described a case of heart failure associated with myocardial inflammation and nests of parasites at autopsy. He described sudden cardiac death associated with arrhythmias in 1911, and its association with complete AV block detected by Jacquet's polygraph as Chagas reported in 1912. Chagas showed the presence of myocardial fibrosis underlying the clinical picture of CCHD in 1916, he presented a full characterization of the clinical aspects of CCHD in 1922. In 1928, Chagas detected fibrosis of the conductive system, and pointed out the presence of marked cardiomegaly at the chest X-Ray associated with minimal symptomatology. The use of serological reaction to diagnose CCHD was put into clinical practice in 1936, after Chagas' death, which along with the 12-lead ECG, revealed the epidemiological importance of CCHD in 1945. In 1953, the long period between initial infection and appearance of CCHD was established, whereas the annual incidence of CCHD from patients with the indeterminate form of the disease was established in 1956. The use of heart catheterization in 1965, exercise stress testing in 1973, Holter monitoring in 1975, Electrophysiologic testing in 1973, echocardiography in 1975, endomyocardial biopsy in 1981, and Magnetic Resonance Imaging in 1995, added to the fundamental clinical aspects of CCHD as described by Carlos Chagas.

Carlos Chagas Discoveries as a Drop Back to Scientific Construction of Chronic Chagas Heart Disease

Energy Technology Data Exchange (ETDEWEB)

Bestetti, Reinaldo B., E-mail: rbestetti44@gmail.com; Restini, Carolina Baraldi A.; Couto, Lucélio B. [Universidade de Ribeirão Preto, Ribeirão Preto, São Paulo, SP (Brazil)

2016-07-15

The scientific construction of chronic Chagas heart disease (CCHD) started in 1910 when Carlos Chagas highlighted the presence of cardiac arrhythmia during physical examination of patients with chronic Chagas disease, and described a case of heart failure associated with myocardial inflammation and nests of parasites at autopsy. He described sudden cardiac death associated with arrhythmias in 1911, and its association with complete AV block detected by Jacquet's polygraph as Chagas reported in 1912. Chagas showed the presence of myocardial fibrosis underlying the clinical picture of CCHD in 1916, he presented a full characterization of the clinical aspects of CCHD in 1922. In 1928, Chagas detected fibrosis of the conductive system, and pointed out the presence of marked cardiomegaly at the chest X-Ray associated with minimal symptomatology. The use of serological reaction to diagnose CCHD was put into clinical practice in 1936, after Chagas' death, which along with the 12-lead ECG, revealed the epidemiological importance of CCHD in 1945. In 1953, the long period between initial infection and appearance of CCHD was established, whereas the annual incidence of CCHD from patients with the indeterminate form of the disease was established in 1956. The use of heart catheterization in 1965, exercise stress testing in 1973, Holter monitoring in 1975, Electrophysiologic testing in 1973, echocardiography in 1975, endomyocardial biopsy in 1981, and Magnetic Resonance Imaging in 1995, added to the fundamental clinical aspects of CCHD as described by Carlos Chagas.

Carlos Chagas Discoveries as a Drop Back to Scientific Construction of Chronic Chagas Heart Disease

Directory of Open Access Journals (Sweden)

Reinaldo B. Bestetti

2016-01-01

Full Text Available Abstract The scientific construction of chronic Chagas heart disease (CCHD started in 1910 when Carlos Chagas highlighted the presence of cardiac arrhythmia during physical examination of patients with chronic Chagas disease, and described a case of heart failure associated with myocardial inflammation and nests of parasites at autopsy. He described sudden cardiac death associated with arrhythmias in 1911, and its association with complete AV block detected by Jacquet's polygraph as Chagas reported in 1912. Chagas showed the presence of myocardial fibrosis underlying the clinical picture of CCHD in 1916, he presented a full characterization of the clinical aspects of CCHD in 1922. In 1928, Chagas detected fibrosis of the conductive system, and pointed out the presence of marked cardiomegaly at the chest X-Ray associated with minimal symptomatology. The use of serological reaction to diagnose CCHD was put into clinical practice in 1936, after Chagas' death, which along with the 12-lead ECG, revealed the epidemiological importance of CCHD in 1945. In 1953, the long period between initial infection and appearance of CCHD was established, whereas the annual incidence of CCHD from patients with the indeterminate form of the disease was established in 1956. The use of heart catheterization in 1965, exercise stress testing in 1973, Holter monitoring in 1975, Electrophysiologic testing in 1973, echocardiography in 1975, endomyocardial biopsy in 1981, and Magnetic Resonance Imaging in 1995, added to the fundamental clinical aspects of CCHD as described by Carlos Chagas.

Optimal use of MRI in clinical trials, clinical care and clinical registries of patients with rheumatoid arthritis

DEFF Research Database (Denmark)

Østergaard, Mikkel; Møller-Bisgaard, Signe

2014-01-01

the benefits of including MRI in treat-to-target strategies. The benefits of incorporating MRI into clinical registries are not yet known, but may include improved knowledge about the real-life advantages of MRI, as well as opportunities to develop better clinical and laboratory composite measures to monitor......Magnetic resonance imaging (MRI) clearly is more sensitive than clinical examination and conventional radiography (x-ray) for detection of inflammation (synovitis, bone marrow oedema (osteitis) and tenosynovitis) and damage (bone erosion and cartilage loss/joint space narrowing) in patients...... with rheumatoid arthritis (RA). The question is when and how MRI should be used. The present article reviews our knowledge about, and provides suggestions for, the use of MRI in clinical trials, clinical care and clinical registries. In clinical trials, the OMERACT RA MRI scoring system (RAMRIS) is a thoroughly...

Browser based platform in maintaining clinical activities – use of the iPads in head and neck clinics

International Nuclear Information System (INIS)

Yang, W Y; Moore, J; Quon, H; Evans, K; Sharabi, A; Herman, J; Hacker-Prietz, A; McNutt, T

2014-01-01

Purpose: Incompatibility between documentation and clinical workflow causes physician resistance in organized data collection, which in turn complicates the use of data in patient care improvement. To resolve the gap, we developed an iPad compatible in situ browser-based platform that integrates clinical activity with data collection and analysis presentation. The ability to perform in-clinic activities and monitor decision making using the iPad was evaluated. Methods: A browser-based platform that can exchange and present analysed data from the MOSAIQ database was developed in situ, the iPads were distributed in head and neck clinics to present the browser for clinical activities, data collection and assessment monitoring. Performance of the iPads for in-clinic activities was observed. Results: All in-clinic documentation activities can be performed without workstation computers. Accessing patient record and previous assessments was significantly faster without having to open the MOSAIQ application. Patient assessments can be completed with the physician facing the patient. Graphical presentation of toxicity progression and patient radiation plans to the patient can be performed in single interface without patient leaving the seating area. Updates in patient treatment status and medical history were presented in real time without having to move paper charts around. Conclusions: The iPad can be used in clinical activities independent of computer workstations. Improvements in clinical workflow can be critical in reducing physician resistance in data maintenance. Using the iPad in providing real-time quality monitoring is intuitive to both providers and patients.

Nebulized formoterol: a review of clinical efficacy and safety in COPD

Directory of Open Access Journals (Sweden)

Nicholas J Gross

2010-06-01

Full Text Available Nicholas J Gross1, James F Donohue21Hines VA Hospital, Stritch Loyola School of Medicine, Hines, IL, USA; 2University of North Carolina School of Medicine, Chapel Hill, NC, USAAbstract: A nebulized formulation of formoterol, Perforomist®, 20 μg/2 ml, has been available since 2007 for the maintenance treatment of chronic obstructive pulmonary disease (COPD. We review the safety and efficacy data obtained during its development. In a dose-finding study, formoterol inhalation solution (FFIS was similar to the formoterol originator, Foradil® 12 μg DPI (FA in patients with COPD. In a 12-week efficacy study, FFIS manifested a rapid onset of action and FEV1 peak, AUC0–12, and trough levels similar to FA. No loss of efficacy, tachyphylaxis, was observed over 12 weeks of regular administration. In placebo-controlled studies in COPD patients receiving maintenance tiotropium, the addition of FFIS significantly augmented bronchodilation over the 6-week treatment duration, signifying that nebulized formoterol can further improve lung function in patients who are receiving tiotropium without an observed increase in adverse reactions. The safety profile of FFIS during 12-week and 1-year studies revealed adverse events that were similar to those of placebo and FA. Cardiac rhythm studies, including frequent ECGs and Holter monitoring, did not indicate any increase in rate or rhythm disturbances greater than placebo or FA. We conclude that maintenance use of Perforomist® is appropriate for patients with COPD who require or prefer a nebulizer for management of their disease.Keywords: long-acting bronchodilator, β-agonist, chronic bronchitis, pulmonary emphysema, Perforomist®, chronic obstructive pulmonary disease

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

Science.gov (United States)

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.

iAssist: a software framework for intelligent patient monitoring.

Science.gov (United States)

Brouse, Christopher; Dumont, Guy; Yang, Ping; Lim, Joanne; Ansermino, J Mark

2007-01-01

A software framework (iAssist) has been developed for intelligent patient monitoring, and forms the foundation of a clinical monitoring expert system. The framework is extensible, flexible, and interoperable. It supports plugins to perform data acquisition, signal processing, graphical display, data storage, and output to external devices. iAssist currently incorporates two plugins to detect change point events in physiological trends. In 38 surgical cases, iAssist detected 868 events, of which clinicians rated more than 50% as clinically significant and less than 7% as artifacts. Clinicians found iAssist intuitive and easy to use.

Safety Evaluation of an Automated Remote Monitoring System for Heart Failure in an Urban, Indigent Population.

Science.gov (United States)

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.

Improving metabolic monitoring in patients maintained on antipsychotics in Penang, Malaysia.

Science.gov (United States)

Hor, Esther Sl; Subramaniam, Sivasangari; Koay, Jun Min; Bharathy, Arokiamary; Vasudevan, Umadevi; Panickulam, Joseph J; Ng, InnTiong; Arif, Nor Hayati; Russell, Vincent

2016-02-01

To evaluate the monitoring of metabolic parameters among outpatients maintained on antipsychotic medications in a general hospital setting in Malaysia and to assess the impact of a local monitoring protocol. By performing a baseline audit of files from a random sample of 300 patients prescribed antipsychotic medications for at least 1 year; we determined the frequency of metabolic monitoring. The findings informed the design of a new local protocol, on which clinical staff was briefed. We re-evaluated metabolic monitoring immediately after implementation, in a small sample of new referrals and current patients. We explored staff perceptions of the initiative with a follow-up focus group, 6 months post-implementation. The baseline audit revealed a sub-optimal frequency of metabolic parameter recording. Re-audit, following implementation of the new protocol, revealed improved monitoring but persisting deficits. Dialogue with the clinical staff led to further protocol modification, clearer definition of staff roles and use of a standard recording template. Focus group findings revealed positive perceptions of the initiative, but persisting implementation barriers, including cultural issues surrounding waist circumference measurement. Responding to challenges in achieving improved routine metabolic monitoring of patients maintained on antipsychotics required on-going dialogue with the clinical staff, in order to address both service pressures and cultural concerns. © The Royal Australian and New Zealand College of Psychiatrists 2015.

Video-based respiration monitoring with automatic region of interest detection

NARCIS (Netherlands)

Janssen, R.J.M.; Wang, Wenjin; Moço, A.; de Haan, G.

2016-01-01

Vital signs monitoring is ubiquitous in clinical environments and emerging in home-based healthcare applications. Still, since current monitoring methods require uncomfortable sensors, respiration rate remains the least measured vital sign. In this paper, we propose a video-based respiration

Challenges of monitoring reproductive health services: a case study ...

African Journals Online (AJOL)

Challenges of monitoring reproductive health services: a case study of antenatal clinics in Kinondoni municipality, Dar Es Salaam. ... was descriptive cross sectional employing both qualitative and quantitative methods. The sample population included nurse-midwives who manage ANC clinics in Kinondoni Municipality.

Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study.

Science.gov (United States)

Lee, Jie-Eun; Lee, Dong Hwa; Oh, Tae Jung; Kim, Kyoung Min; Choi, Sung Hee; Lim, Soo; Park, Young Joo; Park, Do Joon; Jang, Hak Chul; Moon, Jae Hoon

2018-02-21

Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrotoxicosis can be detected by currently available wearable activity trackers, there have been few trials of the clinical application of wearable devices in patients with thyrotoxicosis. The aim of this study is to investigate the clinical applicability of wearable device-generated data to the management of thyrotoxicosis. We are analyzing continuously monitored data for heart rate, physical activity, and sleep in patients with thyrotoxicosis during their clinical course after treatment. Thirty thyrotoxic patients and 10 control subjects were enrolled in this study at Seoul National University Bundang Hospital. Heart rate, physical activity, and sleep are being monitored using a Fitbit Charge HR or Fitbit Charge 2. Clinical data including anthropometric measures, thyroid function test, and hyperthyroidism symptom scale are recorded. Study enrollment began in December 2016, and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by September 2017. This study will provide a foundational feasibility trial of the clinical applications of biosignal measurements to the differential diagnosis, prediction of clinical course, early detection of recurrence, and treatment in patients with thyrotoxicosis. ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2). ©Jie-Eun Lee, Dong Hwa Lee, Tae Jung Oh, Kyoung Min Kim, Sung Hee Choi, Soo Lim, Young Joo Park, Do

Developments in clinical trials: a Pharma Matters report.

Science.gov (United States)

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

2014-08-01

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

Changes in the Skin Conductance Monitor as an End Point for Sympathetic Nerve Blocks.

Science.gov (United States)

Gungor, Semih; Rana, Bhumika; Fields, Kara; Bae, James J; Mount, Lauren; Buschiazzo, Valeria; Storm, Hanne

2017-11-01

There is a lack of objective methods for determining the achievement of sympathetic block. This study validates the skin conductance monitor (SCM) as an end point indicator of successful sympathetic blockade as compared with traditional monitors. This interventional study included 13 patients undergoing 25 lumbar sympathetic blocks to compare time to indication of successful blockade between the SCM indices and traditional measures, clinically visible hyperemia, clinically visible engorgement of veins, subjective skin temperature difference, unilateral thermometry monitoring, bilateral comparative thermometry monitoring, and change in waveform amplitude in pulse oximetry plethysmography, within a 30-minute observation period. Differences in the SCM indices were studied pre- and postblock to validate the SCM. SCM showed substantially greater odds of indicating achievement of sympathetic block in the next moment (i.e., hazard rate) compared with all traditional measures (clinically visible hyperemia, clinically visible engorgement of veins, subjective temperature difference, unilateral thermometry monitoring, bilateral comparative thermometry monitoring, and change in waveform amplitude in pulse oximetry plethysmography; P ≤ 0.011). SCM indicated successful block for all (100%) procedures, while the traditional measures failed to indicate successful blocks in 16-84% of procedures. The SCM indices were significantly higher in preblock compared with postblock measurements (P SCM is a more reliable and rapid response indicator of a successful sympathetic blockade when compared with traditional monitors. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Do adjunctive flap-monitoring technologies impact clinical decision making? An analysis of microsurgeon preferences and behavior by body region.

Science.gov (United States)

Bellamy, Justin L; Mundinger, Gerhard S; Flores, José M; Wimmers, Eric G; Yalanis, Georgia C; Rodriguez, Eduardo D; Sacks, Justin M

2015-03-01

Multiple perfusion assessment technologies exist to identify compromised microvascular free flaps. The effectiveness, operability, and cost of each technology vary. The authors investigated surgeon preference and clinical behavior with several perfusion assessment technologies. A questionnaire was sent to members of the American Society for Reconstructive Microsurgery concerning perceptions and frequency of use of several technologies in varied clinical situations. Demographic information was also collected. Adjusted odds ratios were calculated using multinomial logistic regression accounting for clustering of similar practices within institutions/regions. The questionnaire was completed by 157 of 389 participants (40.4 percent response rate). Handheld Doppler was the most commonly preferred free flap-monitoring technology (56.1 percent), followed by implantable Doppler (22.9 percent) and cutaneous tissue oximetry (16.6 percent). Surgeons were significantly more likely to opt for immediate take-back to the operating room when presented with a concerning tissue oximetry readout compared with a concerning handheld Doppler signal (OR, 2.82; p decision making did not significantly differ by demographics, training, or practice setup. Although most surgeons still prefer to use standard handheld Doppler for free flap assessment, respondents were significantly more likely to opt for immediate return to the operating room for a concerning tissue oximetry reading than an abnormal Doppler signal. This suggests that tissue oximetry may have the greatest impact on clinical decision making in the postoperative period.

Handgrip strength test as a complementary tool in monitoring asthma in daily clinical practice in children.

Science.gov (United States)

Latorre-Román, Pedro Ángel; Navarro-Martínez, Ana Vanesa; Mañas-Bastidas, Alfonso; García-Pinillos, Felipe

2014-12-01

The aim of this study was to demonstrate that handgrip strength test can discriminate the presence/absence of asthma and between intermittent and moderate persistent asthma in children. 140 children (70 healthy and 70 with asthma) completed the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and performed the handgrip strength test. Forty-eight hours later, subjects performed spirometry. The results showed Handgrip strength was significantly lower (pstrength test was a predictive factor for asthma (cut-off at 16.84 kg) and for severity of pathology (cut-off at 15.06 kg). Handgrip strength was reduced in children with asthma. Handgrip strength was positively associated with lung capacity and quality of life. The fact that the handgrip strength test was able to discriminate between presence/absence of asthma and between intermittent and moderate persistent asthma in children suggested that this test could be used as a complementary tool in the monitoring of asthma in daily clinical practice.

Consumption of Caffeinated Products and Cardiac Ectopy.

Science.gov (United States)

Dixit, Shalini; Stein, Phyllis K; Dewland, Thomas A; Dukes, Jonathan W; Vittinghoff, Eric; Heckbert, Susan R; Marcus, Gregory M

2016-01-26

Premature cardiac contractions are associated with increased morbidity and mortality. Though experts associate premature atrial contractions (PACs) and premature ventricular contractions (PVCs) with caffeine, there are no data to support this relationship in the general population. As certain caffeinated products may have cardiovascular benefits, recommendations against them may be detrimental. We studied Cardiovascular Health Study participants with a baseline food frequency assessment, 24-hour ambulatory electrocardiography (Holter) monitoring, and without persistent atrial fibrillation. Frequencies of habitual coffee, tea, and chocolate consumption were assessed using a picture-sort food frequency survey. The main outcomes were PACs/h and PVCs/hour. Among 1388 participants (46% male, mean age 72 years), 840 (61%) consumed ≥1 caffeinated product per day. The median numbers of PACs and PVCs/h and interquartile ranges were 3 (1-12) and 1 (0-7), respectively. There were no differences in the number of PACs or PVCs/h across levels of coffee, tea, and chocolate consumption. After adjustment for potential confounders, more frequent consumption of these products was not associated with ectopy. In examining combined dietary intake of coffee, tea, and chocolate as a continuous measure, no relationships were observed after multivariable adjustment: 0.48% fewer PACs/h (95% CI -4.60 to 3.64) and 2.87% fewer PVCs/h (95% CI -8.18 to 2.43) per 1-serving/week increase in consumption. In the largest study to evaluate dietary patterns and quantify cardiac ectopy using 24-hour Holter monitoring, we found no relationship between chronic consumption of caffeinated products and ectopy. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

A critical assessment of antipsychotic drug monitoring.

Science.gov (United States)

Waraska, J; Nagle, J D

1987-06-01

Analytic problems associated with monitoring antipsychotic drug levels have largely been resolved. Despite the establishment of target values for some drugs, the clinical utility of such levels remains to be determined.

Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder—the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes)

DEFF Research Database (Denmark)

Faurholt-Jepsen, Maria; Vinberg, Maj; Christensen, Ellen Margrethe

2013-01-01

Electronic self-monitoring of affective symptoms using cell phones is suggested as a practical and inexpensive way to monitor illness activity and identify early signs of affective symptoms. It has never been tested in a randomised clinical trial whether electronic self-monitoring improves outcomes...... in bipolar disorder. We are conducting a trial testing the effect of using a Smartphone for self-monitoring in bipolar disorder....

Current and future technologies for remote monitoring in cardiology and evidence from trial data.

Science.gov (United States)

Acosta-Lobos, Andres; Riley, Jillian P; Cowie, Martin R

2012-05-01

All major manufacturers of implantable pacing or defibrillator technologies support remote monitoring of their devices. Integration of signals from several monitored variables can facilitate earlier detection of arrhythmia or technical problems, and can also identify patients at risk of deterioration. Meta-analyses of randomized studies of remote monitoring of heart failure using standalone systems suggest considerable clinical benefit when compared with usual care. However, there may be little to be gained by frequently monitoring patients with well-treated stable disease. Trials of implantable monitoring-only devices suggest that there is a subgroup of patients that may benefit from such remote monitoring. Remote monitoring is still not widely adopted due to a number of social, technological and reimbursement issues, but this is likely to change rapidly. Remote monitoring will not replace face-to-face clinical review, but it will be part of the solution to ever increasing numbers of patients with heart failure and/or an implantable device requiring expert input to their care.

Clinical and biochemical monitoring of patients with fatty acid oxidation disorders

DEFF Research Database (Denmark)

Lund, Allan Meldgaard; Skovby, Flemming; Vestergaard, Helle

2010-01-01

carnitine is measured to monitor carnitine supplementation in patients with multiple acyl-coenzyme A dehydrogenase deficiency (MADD) and carnitine transporter deficiency (CTD) and to follow metabolic control and disclose deficiency states in other FAO disorders. We are evaluating long-chain acylcarnitines...

Quantitative optical diagnostics in pathology recognition and monitoring of tissue reaction to PDT

Science.gov (United States)

Kirillin, Mikhail; Shakhova, Maria; Meller, Alina; Sapunov, Dmitry; Agrba, Pavel; Khilov, Alexander; Pasukhin, Mikhail; Kondratieva, Olga; Chikalova, Ksenia; Motovilova, Tatiana; Sergeeva, Ekaterina; Turchin, Ilya; Shakhova, Natalia

2017-07-01

Optical coherence tomography (OCT) is currently actively introduced into clinical practice. Besides diagnostics, it can be efficiently employed for treatment monitoring allowing for timely correction of the treatment procedure. In monitoring of photodynamic therapy (PDT) traditionally employed fluorescence imaging (FI) can benefit from complementary use of OCT. Additional diagnostic efficiency can be derived from numerical processing of optical diagnostics data providing more information compared to visual evaluation. In this paper we report on application of OCT together with numerical processing for clinical diagnostic in gynecology and otolaryngology, for monitoring of PDT in otolaryngology and on OCT and FI applications in clinical and aesthetic dermatology. Image numerical processing and quantification provides increase in diagnostic accuracy. Keywords: optical coherence tomography, fluorescence imaging, photod

Recognition of clinical deterioration: a clinical leadership opportunity for nurse executive.

Science.gov (United States)

Swartz, Colleen

2013-01-01

Recognition and avoidance of further clinical deterioration can be termed a critical success factor in every care delivery model. As care resources become more constrained and allocated to the most critical of patients, some patients are being shifted to less intense and costly care settings where continuous physiologic monitoring may not be an option. Nurse executives are facing these complex issues as they work with clinical experts to develop systems of safety in the patient care arena. A systematic review of the literature related to the recognition of clinical deterioration is needed to identify areas for further leadership, research, and practice advancements.

Performance and Logistical Challenges of Alternative HIV-1 Virological Monitoring Options in a Clinical Setting of Harare, Zimbabwe

Directory of Open Access Journals (Sweden)

Pascale Ondoa

2014-01-01

Full Text Available We evaluated a low-cost virological failure assay (VFA on plasma and dried blood spot (DBS specimens from HIV-1 infected patients attending an HIV clinic in Harare. The results were compared to the performance of the ultrasensitive heat-denatured p24 assay (p24. The COBAS AmpliPrep/COBAS TaqMan HIV-1 test, version 2.0, served as the gold standard. Using a cutoff of 5,000 copies/mL, the plasma VFA had a sensitivity of 94.5% and specificity of 92.7% and was largely superior to the VFA on DBS (sensitivity = 61.9%; specificity = 99.0% or to the p24 (sensitivity = 54.3%; specificity = 82.3% when tested on 302 HIV treated and untreated patients. However, among the 202 long-term ART-exposed patients, the sensitivity of the VFA decreased to 72.7% and to 35.7% using a threshold of 5,000 and 1,000 RNA copies/mL, respectively. We show that the VFA (either on plasma or on DBS and the p24 are not reliable to monitor long-term treated, HIV-1 infected patients. Moreover, achieving acceptable assay sensitivity using DBS proved technically difficult in a less-experienced laboratory. Importantly, the high level of virological suppression (93% indicated that quality care focused on treatment adherence limits virological failure even when PCR-based viral load monitoring is not available.

Electronically implemented clinical indicators based on a data warehouse in a tertiary hospital: its clinical benefit and effectiveness.

Science.gov (United States)

Yoo, Sooyoung; Kim, Seok; Lee, Kee-Hyuck; Jeong, Chang Wook; Youn, Sang Woong; Park, Kyoung Un; Moon, So Young; Hwang, Hee

2014-07-01

Assessing and monitoring care and service using clinical indicators (CIs) can allow the measurement of and lead to improvements in the quality of care. However, the management and maintenance of CI data has been shown to be difficult because the data are usually collected and provided manually. In this study, for the purpose of efficient managing quality indicators, a data warehouse (DW)-based CI monitoring system was developed. The clinical effectiveness and efficiency of a DW-based CI monitoring was investigated through several case studies of the system's operation at a tertiary hospital. This study analyzed the CIs that have been developed over the past 8 years at a 1340-bed tertiary general university hospital in South Korea to improve and monitor the quality of care and patient safety. The hospital was opened as a fully digital hospital in 2003, and the CIs were computerized in 2005 by implementing a DW-based CI monitoring system. We classified the computerized CIs and evaluated the monitoring results for several representative CIs, such as the optimal prescribing of preventive antibiotics, the average length of stay, the mortality rate, and the rehospitalization rate. During the development of the system in 2005, 12 of 19 CIs were computerized, and this number gradually increased until 299 of 335 CIs were computerized by 2012. In addition, among the CIs built computationally through the CI task force team, focal CIs subject to monitoring were selected annually, and the results of this monitoring were shared with all of the staff or the related department and its staff. By providing some examples of our CI monitoring results, we showed the feasibility of improving the quality of care, and maintaining the optimum level of patient care with less labor. The results of this study provide evidence regarding the clinical effectiveness and efficiency as well as the systems operation experience of a DW-based CI monitoring system. These findings may aid medical

Exercise-Induced Ventricular Fibrillation: Seven Years Follow-Up

Directory of Open Access Journals (Sweden)

Gökmen Gemici

2011-11-01

Full Text Available We present a 7-year follow-up of a 55-year-old male who experienced ventricular fibrillation during the recovery period of exercise testing and refused implantation of an ICD. Normal left ventricular systolic function was found on echocardiographic examination, and coronary angiography revealed only a side branch disease with a vessel diameter of less than 2 millimeters. The patient was discharged on metoprolol and ASA in addition to his previous treatment with lisinopril and simvastatin. Outpatient cardiac evaluation by repeated 24-hour ECG monitorizations (Holter revealed normal findings. On follow up visits every six months for the past seven years, the patient was found to be asymptomatic.

Eccentric apical hypertrophic cardiomyopathy unmasked by multimodality imaging: an uncommon but missed cause of out of hospital cardiac arrest

Science.gov (United States)

Towe, Eric; Sharma, Saurabh; Geske, Jeffrey; Ackerman, Michael J

2015-01-01

A woman in her late 50s experienced a witnessed, sudden out of hospital cardiac arrest. Initial workup included coronary angiography, transthoracic echocardiogram and a CT scan of the chest to rule out pulmonary embolus. She was subsequently discharged home without an implantable cardioverter defibrillator (ICD) or a life vest. On follow-up at another facility, an ICD was placed and a Holter monitor showed no ventricular ectopy. Further transthoracic echocardiographic images were obtained, which were suggestive of apical hypertrophic cardiomyopathy. A limited transthoracic echocardiogram with contrast was performed, which did not elucidate the hypertrophy. However, eccentric left ventricular apical wall hypertrophy was visualised by a coronary CT scan. PMID:26153133

Electronic monitoring in bipolar disorder

DEFF Research Database (Denmark)

Faurholt-Jepsen, Maria

2018-01-01

generated data (e.g. the number of text messages sent/day; the number of incoming and outgoing calls/day; the number of changes in cell tower IDs/day; and voice features) seem to reflect clinically assessed depressive and manic symptoms in bipolar disorder; 3) smartphone-based electronic self-monitoring had...

Applicability of structured telephone monitoring to follow up heart ...

African Journals Online (AJOL)

Over 90% of the contacted patients gave valuable information regarding their clinical status. Conclusion: Majority of HF patients can be contacted and provide valuable clinical information through mobile phones within a month post discharge from the national hospital in Tanzania. Structured telephone monitoring could be ...

77 FR 60440 - Clinical Investigator Training Course

Science.gov (United States)

2012-10-03

... concerns, adverse event monitoring, compliance with the legal and ethical obligations of clinical research... with knowledge, experience, and commitment to investigational medicine; Promote communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in experimental medicine...

Monitoring of performance management using Quality Assurance Indicators and ISO requirement

Directory of Open Access Journals (Sweden)

Dargahi H

2007-06-01

Full Text Available Background: Quality assurance is a prevention-oriented system that can be used to improve the quality of care, increase productivity and monitor the performance management in clinical laboratories. ISO 9001: 2000 requirements are a collection of management and technical systems designed to implement quality assurance and monitor performance management in organizations. Methods: A checklist was prepared to monitor the preanalytical, analytical and postanalytical stages of laboratory performance management in 16 areas and all laboratory activities in 14 of the clinical laboratories of the Tehran University of Medical Sciences (TUMS hospitals. Collected data were stored and statistically analyzed using SPSS software. Results: The best performance, in which 77.73% of quality assurance indicators were observed, was found in Sina Hospital. However, only 57.56% of these indicators were fulfilled at Farabi Hospital, with the lowest-level performance among the clinical laboratories of TUMS hospitals. The highest level of compliance with quality assurance indicators was in the hematology departments and for facility demands in management areas. Overall, quality assurance indicators were appropriately followed in only 7% of the clinical laboratories. Conclusion: The average quality assurance observation rate in the clinical laboratories studied was 67.22%, which is insufficient and must be remedied with stricter enforcement of the ISO 9001: 2000 regulations.

[Development of automatic urine monitoring system].

Science.gov (United States)

Wei, Liang; Li, Yongqin; Chen, Bihua

2014-03-01

An automatic urine monitoring system is presented to replace manual operation. The system is composed of the flow sensor, MSP430f149 single chip microcomputer, human-computer interaction module, LCD module, clock module and memory module. The signal of urine volume is captured when the urine flows through the flow sensor and then displayed on the LCD after data processing. The experiment results suggest that the design of the monitor provides a high stability, accurate measurement and good real-time, and meets the demand of the clinical application.

Clinical Studies of Real-Time Monitoring of Lithotripter Performance Using Passive Acoustic Sensors

Science.gov (United States)

Leighton, T. G.; Fedele, F.; Coleman, A. J.; McCarthy, C.; Ryves, S.; Hurrell, A. M.; De Stefano, A.; White, P. R.

2008-09-01

This paper describes the development and clinical testing of a passive device which monitors the passive acoustic emissions generated within the patient's body during Extracorporeal Shock Wave Lithotripsy (ESWL). Designed and clinically tested so that it can be operated by a nurse, the device analyses the echoes generated in the body in response to each ESWL shock, and so gives real time shock-by-shock feedback on whether the stone was at the focus of the lithotripter, and if so whether the previous shock contributed to stone fragmentation when that shock reached the focus. A shock is defined as being `effective' if these two conditions are satisfied. Not only can the device provide real-time feedback to the operator, but the trends in shock `effectiveness' can inform treatment. In particular, at any time during the treatment (once a statistically significant number of shocks have been delivered), the percentage of shocks which were `effective' provides a treatment score TS(t) which reflects the effectiveness of the treatment up to that point. The TS(t) figure is automatically delivered by the device without user intervention. Two clinical studies of the device were conducted, the ethics guidelines permitting only use of the value of TS(t) obtained at the end of treatment (this value is termed the treatment score TS0). The acoustically-derived treatment score was compared with the treatment score CTS2 given by the consultant urologist at the three-week patient's follow-up appointment. In the first clinical study (phase 1), records could be compared for 30 out of the 118 patients originally recruited, and the results of phase 1 were used to refine the parameter values (the `rules') with which the acoustic device provides its treatment score. These rules were tested in phase 2, for which records were compared for 49 of the 85 patients recruited. Considering just the phase 2 results (since the phase 1 data were used to draw up the `rules' under which phase 2 operated

Electronic monitoring of adherence to inhaled corticosteroids: an essential tool in identifying severe asthma in children.

Science.gov (United States)

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.

76 FR 45577 - Clinical Investigator Training Course

Science.gov (United States)

2011-07-29

... concerns, adverse event monitoring, compliance with the legal and ethical obligations of clinical research... knowledge, experience, and commitment to investigational medicine; Promote communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in experimental medicine; and Improve...

Clinical dosimetry

International Nuclear Information System (INIS)

Rassow, J.

1973-01-01

The main point of this paper on clinical dosimetry which is to be understood here as application of physical dosimetry on accelerators in medical practice, is based on dosimetric methodics. Following an explanation of the dose parameters and description of the dose distribution important for clinical practice as well as geometric irradiation parameters, the significance of a series of physical parameters such as accelerator energy, surface energy of average stopping power etc. is dealt with in detail. Following a section on field homogenization with bremsstrahlung and electron radiation, details on dosimetry in clinical practice are given. Finally, a few problems of dosemeter or monitor calibration on accelerators are described. The explanations are supplemented by a series of diagrams and tables. (ORU/LH) [de

Analysis of clinical data to determine the minimum number of sensors required for adequate skin temperature monitoring of superficial hyperthermia treatments.

Science.gov (United States)

Bakker, Akke; Holman, Rebecca; Rodrigues, Dario B; Dobšíček Trefná, Hana; Stauffer, Paul R; van Tienhoven, Geertjan; Rasch, Coen R N; Crezee, Hans

2018-04-27

Tumor response and treatment toxicity are related to minimum and maximum tissue temperatures during hyperthermia, respectively. Using a large set of clinical data, we analyzed the number of sensors required to adequately monitor skin temperature during superficial hyperthermia treatment of breast cancer patients. Hyperthermia treatments monitored with >60 stationary temperature sensors were selected from a database of patients with recurrent breast cancer treated with re-irradiation (23 × 2 Gy) and hyperthermia using single 434 MHz applicators (effective field size 351-396 cm 2 ). Reduced temperature monitoring schemes involved randomly selected subsets of stationary skin sensors, and another subset simulating continuous thermal mapping of the skin. Temperature differences (ΔT) between subsets and complete sets of sensors were evaluated in terms of overall minimum (T min ) and maximum (T max ) temperature, as well as T90 and T10. Eighty patients were included yielding a total of 400 hyperthermia sessions. Median ΔT was 50 sensors were used. Subsets of sensors result in underestimation of T max up to -2.1 °C (ΔT 95%CI), which decreased to -0.5 °C when >50 sensors were used. Thermal profiles (8-21 probes) yielded a median ΔT 50 stationary sensors or thermal profiles. Adequate coverage of the skin temperature distribution during superficial hyperthermia treatment requires the use of >50 stationary sensors per 400 cm 2 applicator. Thermal mapping is a valid alternative.

Noninvasive diagnosis of allograft vascular disease after heart transplantation

Directory of Open Access Journals (Sweden)

Fernando Bacal

2001-01-01

Full Text Available OBJECTIVE: To determine the predictive values of noninvasive tests for the detection of allograft vascular disease. METHODS: We studied 39 patients with mean ages of 48±13 years and a follow-up period of 86±13 months. The diagnosis of allograft vascular disease was made by cine-coronary arteriography, and it was considered as positive if lesions existed that caused > or = 50% obstruction of the lumen. Patients underwent 24h Holter monitoring, thallium scintigraphy, a treadmill stress test, and dobutamine stress echocardiography. Sensitivity, specificity, and positive and negative predictive values were determined in percentages for each method, as compared with the cine-coronary arteriography results. RESULTS: Allograft vascular disease was found in 15 (38% patients. The Holter test showed 15.4% sensitivity, 95.5% specificity. For the treadmill stress test, sensitivity was 10%, specificity was 100%. When thallium scintigraphy was used, sensitivity was 40%, specificity 95.8%. On echocardiography with dobutamine, we found a 63.6% sensitivity, 91.3% specificity. When the dobutamine echocardiogram was associated with scintigraphy, sensitivity was 71.4%, specificity was 87%. CONCLUSION: In this group of patients, the combination of two noninvasive methods (dobutamine echocardiography and thallium scintigraphy may be a good alternative for the detection of allograft vascular disease in asymptomatic patients with normal ventricular function.

A dose monitoring system for dental radiography

Energy Technology Data Exchange (ETDEWEB)

Lee, Chena; Lee, Sam Sun; Kim, Jo Eun; Huh, Kyung Hoe; Yi, Woo Jin; Heo, Min Suk; Choi, Soon Chul [Dept. of Oral and Maxillofacial Radiology and Dental Research Institute, School of Dentistry, Seoul National University, Seoul (Korea, Republic of); Symkhampha, Khanthaly [Dept. of Oral and Maxillofacial Radiology, Department of Basic Science, Faculty of Dentistry, University of Health Sciences, Vientiane (Lao People' s Democratic Republic); Lee, Woo Jin [Dept. of Interdisciplinary Program in Radiation, Applied Life Sciences Major, College of Medicine, BK21, and Dental Research Institute, Seoul National University, Seoul (Korea, Republic of); Yeom, Heon Young [School of Computer Science Engineering, Seoul National University, Seoul (Korea, Republic of)

2016-06-15

The current study investigates the feasibility of a platform for a nationwide dose monitoring system for dental radiography. The essential elements for an unerring system are also assessed. An intraoral radiographic machine with 14 X-ray generators and five sensors, 45 panoramic radiographic machines, and 23 cone-beam computed tomography (CBCT) models used in Korean dental clinics were surveyed to investigate the type of dose report. A main server for storing the dose data from each radiographic machine was prepared. The dose report transfer pathways from the radiographic machine to the main sever were constructed. An effective dose calculation method was created based on the machine specifications and the exposure parameters of three intraoral radiographic machines, five panoramic radiographic machines, and four CBCTs. A viewing system was developed for both dentists and patients to view the calculated effective dose. Each procedure and the main server were integrated into one system. The dose data from each type of radiographic machine was successfully transferred to the main server and converted into an effective dose. The effective dose stored in the main server is automatically connected to a viewing program for dentist and patient access. A patient radiation dose monitoring system is feasible for dental clinics. Future research in cooperation with clinicians, industry, and radiologists is needed to ensure format convertibility for an efficient dose monitoring system to monitor unexpected radiation dose.

Monitoring asthma in childhood: management-related issues

Directory of Open Access Journals (Sweden)

Bart L. Rottier

2015-06-01

Full Text Available Management-related issues are an important aspect of monitoring asthma in children in clinical practice. This review summarises the literature on practical aspects of monitoring including adherence to treatment, inhalation technique, ongoing exposure to allergens and irritants, comorbid conditions and side-effects of treatment, as agreed by the European Respiratory Society Task Force on Monitoring Asthma in Childhood. The evidence indicates that it is important to discuss adherence to treatment in a non-confrontational way at every clinic visit, and take into account a patient's illness and medication beliefs. All task force members teach inhalation techniques at least twice when introducing a new inhalation device and then at least annually. Exposure to second-hand tobacco smoke, combustion-derived air pollutants, house dust mites, fungal spores, pollens and pet dander deserve regular attention during follow-up according to most task force members. In addition, allergic rhinitis should be considered as a cause for poor asthma control. Task force members do not screen for gastro-oesophageal reflux and food allergy. Height and weight are generally measured at least annually to identify individuals who are susceptible to adrenal suppression and to calculate body mass index, even though causality between obesity and asthma has not been established. In cases of poor asthma control, before stepping up treatment the above aspects of monitoring deserve closer attention.

A dose monitoring system for dental radiography

International Nuclear Information System (INIS)

Lee, Chena; Lee, Sam Sun; Kim, Jo Eun; Huh, Kyung Hoe; Yi, Woo Jin; Heo, Min Suk; Choi, Soon Chul; Symkhampha, Khanthaly; Lee, Woo Jin; Yeom, Heon Young

2016-01-01

The current study investigates the feasibility of a platform for a nationwide dose monitoring system for dental radiography. The essential elements for an unerring system are also assessed. An intraoral radiographic machine with 14 X-ray generators and five sensors, 45 panoramic radiographic machines, and 23 cone-beam computed tomography (CBCT) models used in Korean dental clinics were surveyed to investigate the type of dose report. A main server for storing the dose data from each radiographic machine was prepared. The dose report transfer pathways from the radiographic machine to the main sever were constructed. An effective dose calculation method was created based on the machine specifications and the exposure parameters of three intraoral radiographic machines, five panoramic radiographic machines, and four CBCTs. A viewing system was developed for both dentists and patients to view the calculated effective dose. Each procedure and the main server were integrated into one system. The dose data from each type of radiographic machine was successfully transferred to the main server and converted into an effective dose. The effective dose stored in the main server is automatically connected to a viewing program for dentist and patient access. A patient radiation dose monitoring system is feasible for dental clinics. Future research in cooperation with clinicians, industry, and radiologists is needed to ensure format convertibility for an efficient dose monitoring system to monitor unexpected radiation dose

Experiencia clínica en monitorización cardiaca extendida con el sistema inalámbrico satelital tipo SEEQ

Directory of Open Access Journals (Sweden)

Diego Vanegas-Cadavid

2018-05-01

Full Text Available Resumen: Objetivos: Dar a conocer la experiencia clínica con un nuevo sistema de monitorización cardiaca extendida (por 15 días, inalámbrica y satelital en un grupo de pacientes con sospecha de arritmias cardíacas. Metodología: Cohorte de 100 pacientes atendidos en la unidad de Electrofisiología cardiovascular de un centro de referencia, con sospecha de arritmia cardíaca, sin diagnóstico electrocardiográfico causal, a pesar de exámenes previos. Se les aplicó una monitorización cardiaca externa tipo SEEQ (Medtronic por 15 días y se registró el desenlace. Resultados: De un total de 100 sujetos estudiados, 51% eran hombres, con mediana de edad de 60 años (rango: 5 - 91 años. El principal síntoma fueron las palpitaciones (42% y la comorbilidad más prevalente la hipertensión arterial (47%; 98% tenían estudio de Holter previo y 46% dos estudios sin resultado conclusivo que explicara los síntomas. La monitorización tipo SEEQ documentó anormalidad electrocardiográfica significativa en 22% de los pacientes. El implante de marcapaso fue el tratamiento más aplicado y la fibrilación auricular fue la arritmia más frecuente en el 50% de los hallazgos positivos. Hubo una proporción mayor y significativa de diagnósticos positivos en el sexo masculino. Conclusiones: La monitorización cardiaca externa inalámbrica, satelital, extendida por 15 días es una herramienta novedosa que incrementa la probabilidad de documentar una anormalidad electrocardiográfica clínicamente significativa en quienes padecen síntomas cardiovasculares recurrentes. Abstract: Objectives: To present the clinical experience with a new extended (for 15 days, wireless, and satellite cardiac monitoring system in a group of patients with suspicion of cardiac arrhythmia. Method: The study included a cohort of 100 patients seen in the Cardiovascular Electrophysiology Unit of a reference hospital. They were suspected of having a cardiac arrhythmia, with no

Monitoring long-term oral corticosteroids.

Science.gov (United States)

Mundell, Lewis; Lindemann, Roberta; Douglas, James

2017-01-01

Corticosteroids are synthetic analogues of human hormones normally produced by the adrenal cortex. They have both glucocorticoid and mineralocorticoid properties. The glucocortoid components are anti-inflammatory, immunosuppressive, anti-proliferative and vasoconstrictive. They influence the metabolism of carbohydrate and protein, in addition to playing a key role in the body's stress response. Mineralocorticoid's main significance is in the balance of salt and water concentrations. Due to the combination of these effects, corticosteroids can cause many adverse effects. Oral corticosteroids are absorbed systemically and are therefore more likely to cause adverse effects than topical or inhaled corticosteroids. Furthermore, it is assumed that greater duration of treatment will lead to a greater number of adverse effects, and therefore the most at risk group are those taking high dose, long-term oral corticosteroids (LTOC). High dose is defined as a prescription of >5 mg oral prednisolone and long term as duration of treatment >1 month (based on National Institute for Health and Care Excellence guidance for patient's 'at risk' of systemic side effects). Parameters to be monitored in primary care include weight, blood pressure, triglycerides, glucose and urea and electrolytes. From clinical experience within the general practice setting, the authors propose that these patients do not receive adequate baseline monitoring before starting corticosteroids nor are these markers monitored consistently thereafter. This project intended to evidence this claim, evaluate the adverse effect profile and improve monitoring in this patient group. The initial audit of 22 patients, within a single general practice, detected at least one documented adverse effect in 64% of patients, while 41% reported more than one adverse effect. 45% had recorded weight gain, 18% had recorded osteoporosis, 18% had at least one recorded cataract, 14% had recorded Hypertension, 14% had recorded

A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

DEFF Research Database (Denmark)

Rasmussen, Benjamin S B; Froekjaer, Johnny; Bjerregaard, Mads R

2015-01-01

OBJECTIVE: The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS: Of the 736 screened...... individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted...... monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical...

Continuous Glucose Monitoring (CGM) or Blood Glucose Monitoring (BGM): Interactions and Implications.

Science.gov (United States)

Heinemann, Lutz

2018-04-01

At the 2017 10th annual International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Paris, France, four speakers presented their perspectives on the roles of continuous glucose monitoring (CGM) and of blood glucose monitoring (BGM) in patient management within one symposium. These presentations included discussions of the differences in the accuracy of CGM and BGM, a clinical perspective on the physiological reasons behind differences in CGM and BGM values, and an overview of the impact of variations in device accuracy on patients with diabetes. Subsequently a short summary of these presentations is given, highlighting the value of good accuracy of BGM or CGM systems and the ongoing need for standardization. The important role of both BGM and CGM in patient management was a theme across all presentations.

Caries assessment: establishing mathematical link of clinical and benchtop method

Science.gov (United States)

Amaechi, Bennett T.

2009-02-01

It is well established that the development of new technologies for early detection and quantitative monitoring of dental caries at its early stage could provide health and economic benefits ranging from timely preventive interventions to reduction of the time required for clinical trials of anti-caries agents. However, the new technologies currently used in clinical setting cannot assess and monitor caries using the actual mineral concentration within the lesion, while a laboratory-based microcomputed tomography (MCT) has been shown to possess this capability. Thus we envision the establishment of mathematical equations relating the measurements of each of the clinical technologies to that of MCT will enable the mineral concentration of lesions detected and assessed in clinical practice to be extrapolated from the equation, and this will facilitate preventitive care in dentistry to lower treatment cost. We utilize MCT and the two prominent clinical caries assessment devices (Quantitative Light-induced Fluorescence [QLF] and Diagnodent) to longitudinally monitor the development of caries in a continuous flow mixed-organisms biofilm model (artificial mouth), and then used the collected data to establish mathematical equation relating the measurements of each of the clinical technologies to that of MCT. A linear correlation was observed between the measurements of MicroCT and that of QLF and Diagnodent. Thus mineral density in a carious lesion detected and measured using QLF or Diagnodent can be extrapolated using the developed equation. This highlights the usefulness of MCT for monitoring the progress of an early caries being treated with therapeutic agents in clinical practice or trials.

Electronic monitoring of patients with bipolar affective disorder

DEFF Research Database (Denmark)

Jacoby, Anne Sophie; Faurholt-Jepsen, Maria; Vinberg, Maj

2012-01-01

Bipolar disorder is a great challenge to patients, relatives and clinicians, and there is a need for development of new methods to identify prodromal symptoms of affective episodes in order to provide efficient preventive medical and behavioural intervention. Clinical trials prove that electronic...... monitoring is a feasible, valid and acceptable method. Hence it is recommended, that controlled trials on the effect of electronic monitoring on patients' course of illness, level of function and quality of life are conducted.......Bipolar disorder is a great challenge to patients, relatives and clinicians, and there is a need for development of new methods to identify prodromal symptoms of affective episodes in order to provide efficient preventive medical and behavioural intervention. Clinical trials prove that electronic...

The North Zealand CAP Monitor

DEFF Research Database (Denmark)

Nielsen, Minna; Ravn, Pernille; Notander Clausen, Lise

with CAP. We started with 34 audit variables. Through repeated cycles of testing, feedback and discussions, we reduced the number of indicators to 22 and time per audit from 20 to 10 minutes. Strategy for change To link the monitoring system with our patient pathway for CAP we established an improvement...... Designing a database Designing and testing a dashboard to present indicators in a balanced way Messages for others Auditing patients with a common disease as CAP is useful to identify areas for improvement for a large group of patients. The baseline audit can serve as a basis for a monitoring system......Contect We describe how we developed a monitoring system for community acquired pneumonia (CAP) at North Zealand Regional hospital. We serve 310.000 inhabitants and annually around 3200 patients with CAP are admitted. As part of a program of clinical pathways for common conditions, a pathway...

Monitoring health related quality of life in adolescents with diabetes

DEFF Research Database (Denmark)

de Wit, M; Delemarre-van de Waal, Henriette A; Pouwer, F

2007-01-01

Particularly in chronic conditions, monitoring health related quality of life (HRQoL) of adolescents in clinical practice is increasingly advocated. We set out to identify and review the clinical utility of available generic and diabetes specific HRQoL questionnaires suitable for use in adolescents...

PHOX2B mutation-confirmed congenital central hypoventilation syndrome in a Chinese family: presentation from newborn to adulthood.

Science.gov (United States)

Lee, Peilin; Su, Yi-Ning; Yu, Chong-Jen; Yang, Pan-Chyr; Wu, Huey-Dong

2009-02-01

Congenital central hypoventilation syndrome (CCHS) is characterized by compromised chemoreflexes resulting in sleep hypoventilation. We report a Chinese family with paired-like homeobox 2B (PHOX2B) mutation-confirmed CCHS, with a clinical spectrum from newborn to adulthood, to increase awareness of its various manifestations. After identifying central hypoventilation in an adult man (index case), clinical evaluation was performed on the complete family, which consisted of the parents, five siblings, and five offspring. Pulmonary function tests, overnight polysomnography, arterial blood gas measurements, hypercapnia ventilatory response, and PHOX2B gene mutation screening were performed on living family members. Brain MRI, 24-h Holter monitoring, and echocardiography were performed on members with clinically diagnosed central hypoventilation. The index patient and four offspring manifested clinical features of central hypoventilation. The index patients had hypoxia and hypercapnia while awake, polycythemia, and hematocrit levels of 70%. The first and fourth children had frequent cyanotic spells, and both died of respiratory failure. The second and third children remained asymptomatic until adulthood, when they experienced impaired hypercapnic ventilatory response. The third child had nocturnal hypoventilation with nadir pulse oximetric saturation of 59%. Adult-onset CCHS with PHOX2B gene mutation of the + 5 alanine expansions were confirmed in the index patient and the second and third children. The index patient and the third child received ventilator support system bilevel positive airway pressure treatment, which improved the hypoxemia, hypercapnia, and polycythemia without altering their chemosensitivity. Transmission of late-onset CCHS is autosomal-dominant. Genetic screening of family members of CCHS probands allows for early diagnosis and treatment.

Heart rate autonomic regulation system at rest and during paced breathing among patients with CRPS as compared to age-matched healthy controls.

Science.gov (United States)

Bartur, Gadi; Vatine, Jean-Jacques; Raphaely-Beer, Noa; Peleg, Sara; Katz-Leurer, Michal

2014-09-01

The objective of this study is to assess the autonomic nerve heart rate regulation system at rest and its immediate response to paced breathing among patients with complex regional pain syndrome (CRPS) as compared with age-matched healthy controls. Quasiexperimental. Outpatient clinic. Ten patients with CRPS and 10 age- and sex-matched controls. Participants underwent Holter ECG (NorthEast Monitoring, Inc., Maynard, MA, USA) recording during rest and biofeedback-paced breathing session. Heart rate variability (HRV), time, and frequency measures were assessed. HRV and time domain values were significantly lower at rest among patients with CRPS as compared with controls. A significant association was noted between pain rank and HRV frequency measures at rest and during paced breathing; although both groups reduced breathing rate significantly during paced breathing, HRV time domain parameters increased only among the control group. The increased heart rate and decreased HRV at rest in patients with CRPS suggest a general autonomic imbalance. The inability of the patients to increase HRV time domain values during paced breathing may suggest that these patients have sustained stress response with minimal changeability in response to slow-paced breathing stimuli. Wiley Periodicals, Inc.

Electrocardiogram PR Interval Is a Surrogate Marker to Predict New Occurrence of Atrial Fibrillation in Patients with Frequent Premature Atrial Contractions.

Science.gov (United States)

Chun, Kwang Jin; Hwang, Jin Kyung; Choi, So Ra; Park, Seung-Jung; On, Young Keun; Kim, June Soo; Park, Kyoung-Min

2016-04-01

The clinical significance of prolonged PR interval has not been evaluated in patients with frequent premature atrial contractions (PACs). We investigated whether prolonged PR interval could predict new occurrence of atrial fibrillation (AF) in patients with frequent PACs. We retrospectively analyzed 684 patients with frequent PACs (> 100 PACs/day) who performed repeated 24-hour Holter monitoring. Prolonged PR interval was defined as longer than 200 msec. Among 684 patients, 626 patients had normal PR intervals (group A) and 58 patients had prolonged PR intervals (group B). After a mean follow-up of 59.3 months, 14 patients (24.1%) in group B developed AF compared to 50 patients (8.0%) in group A (P PR interval (hazard ratio [HR], 1.950; 95% CI, 1.029-3.698; P = 0.041), age (HR, 1.033; 95% CI, 1.006-1.060; P = 0.015), and left atrial (LA) dimension (HR, 1.061; 95% CI, 1.012-1.112; P = 0.015) were associated with AF occurrence. Prolonged PR interval, advanced age, and enlarged LA dimension are independent risk factors of AF occurrence in patients with frequent PACs.

Testing telehealth using technology-enhanced nurse monitoring.

Science.gov (United States)

Grant, Leslie A; Rockwood, Todd; Stennes, Leif

2014-10-01

Technology-enhanced nurse monitoring is a telehealth solution that helps nurses with assessment, diagnosis, and triage of older adults living in community-based settings. This technology links biometric and nonbiometric sensors to a data management system that is monitored remotely by RNs and unlicensed support staff. Nurses faced a number of challenges related to data interpretation, including making clinical inferences from nonbiometric data, integrating data generated by three different telehealth applications into a clinically meaningful cognitive framework, and figuring out how best to use nursing judgment to make valid inferences from online reporting systems. Nurses developed expertise over the course of the current study. The sponsoring organization achieved a high degree of organizational knowledge about how to use these systems more effectively. Nurses saw tremendous value in the telehealth applications. The challenges, learning curve, and organizational improvements are described. Copyright 2014, SLACK Incorporated.

Machine Learning Techniques in Clinical Vision Sciences.

Science.gov (United States)

Caixinha, Miguel; Nunes, Sandrina

2017-01-01

This review presents and discusses the contribution of machine learning techniques for diagnosis and disease monitoring in the context of clinical vision science. Many ocular diseases leading to blindness can be halted or delayed when detected and treated at its earliest stages. With the recent developments in diagnostic devices, imaging and genomics, new sources of data for early disease detection and patients' management are now available. Machine learning techniques emerged in the biomedical sciences as clinical decision-support techniques to improve sensitivity and specificity of disease detection and monitoring, increasing objectively the clinical decision-making process. This manuscript presents a review in multimodal ocular disease diagnosis and monitoring based on machine learning approaches. In the first section, the technical issues related to the different machine learning approaches will be present. Machine learning techniques are used to automatically recognize complex patterns in a given dataset. These techniques allows creating homogeneous groups (unsupervised learning), or creating a classifier predicting group membership of new cases (supervised learning), when a group label is available for each case. To ensure a good performance of the machine learning techniques in a given dataset, all possible sources of bias should be removed or minimized. For that, the representativeness of the input dataset for the true population should be confirmed, the noise should be removed, the missing data should be treated and the data dimensionally (i.e., the number of parameters/features and the number of cases in the dataset) should be adjusted. The application of machine learning techniques in ocular disease diagnosis and monitoring will be presented and discussed in the second section of this manuscript. To show the clinical benefits of machine learning in clinical vision sciences, several examples will be presented in glaucoma, age-related macular degeneration