Clinical trials for elderly patients with multiple diseases (CHROMED) pilot study

The problem COPD (Chronic Obstructive Pulmonary Disease) is a significant socioeconomic burden which, particularly when associated with comorbidities such as Chronic Heart Failure (CHF), markedly affects patient outcomes. Care models based on telemedicine systems that enable early diagnosis and treatment of exacerbations are advocated to reduce the impact of chronic diseases on patient outcomes and health service costs. CHROMED (www.chromed.eu) is an international EU-funded project aimed at developing a multi-centre clinical trial to evaluate the impact of a new integrated home care approach to reduce care costs and improve quality of life in COPD. The approach We collaborated in a pilot study prior to the main trial which will include 300 patients from seven European countries (Italy, Spain, UK, Estonia, Slovenia, Sweden and Norway) with nine partners. The home monitoring system includes a novel forced oscillation technique (FOT) device for self-measurement of lung mechanics (RESMONPRO DIARY, Restech srl, Italy), a touch screen for collecting patients' symptoms and, where COPD is associated with CHF, by a device for measuring heart rate (HR), blood pressure (BP), pulse oximetry (SpO2) and body temperature (WRIST CLINIC, Medic4all, Israel). Findings The pilot included 16 patients (n=11 COPD, 5 COPD+CHF). The average monitoring period was 48.3±23.4 days resulting in a total of 504 patient days. The percentage of data correctly received within the period was: lung impedance and breathing pattern 90.0%; HR 91.7%, BP 91.7%; SpO2 74.0% and body temperature 71.4%. During the pilot, one patient was treated pharmacologically for an exacerbation of COPD. Offline processing demonstrated that the system identified warning of an exacerbation five days prior to admission. We also analysed qualitative data from patients and professionals about the acceptability of the telemedicine system and the interaction between patients, professionals and the monitoring system. Consequences The data suggest good acceptability and short-term compliance among patients with COPD. Lung function, HR and BP provided the most reliable data. The full RCT is currently under way and will be completed in August 2015

Characterization of speech and language phenotype in GLUT1DS

Background: To analyze the oral motor, speech and language phenotype in a sample of pediatric patients with GLUT 1 transporter deficiency syndrome (GLUT1DS). Methods: eight Italian-speaking children with GLUT1DS (aged 4.6–15.4 years) in stable treatment with ketogenic diet from a variable time underwent a specific and standardized speech and language assessment battery. Results: All patients showed deficits with different degrees of impairment in multiple speech and language areas. In particular, orofacial praxis, parallel and total movements were the most impaired in the oromotor domain; in the speech domain patients obtained a poor performance in the diadochokinesis rate and in the repetition of words that resulted as severely deficient in seven out of eight patients; in the language domain the most affected abilities were semantic/phonological fluency and receptive grammar. Conclusions: GLUT1DS is associated to different levels of speech and language impairment, which should guide diagnostic and therapeutic intervention. Larger population data are needed to identify more precisely a speech and language profile in GLUT1DS patients

Speckle tracking echocardiography in dogs with patent ductus arteriosus : effect of percutaneous closure on cardiac mechanics

Background : patent ductus arteriosus (PDA) is one of the most common congenital heart defects in the dog and percutaneous closure is effective in achieving ductal closure.PDA closure is associated with abrupt hemodynamic changes. Hypothesis: A marked reduction in standard parameters of systolic function as assessed by M/B mode after PDA closure was identified in previous studies. Speckle-tracking echocardiography(STE) can provide further insight into the effect of PDA closure on cardiac mechanics in dogs affected by PDA. Animals: 25 client owned dogs affected by PDA Methods: Prospective study. Complete echocardiographic evaluation was performed before and 24 hours after PDA closure, including standard (EDVIB/M, ESVIB/M, AlloD/S, Qp/Qs, SI, EF and FS) and STE (global longitudinal, radial, transversal and circumferential strain and strain rate). Results: PDA closure was associated with a statistically significant decrease in conventional echocardiographic parameters and a derease in the absolute values of radial, transversal and circumferential S and SR, while longitudinal S and SR did not change significantly. Conclusion and clinical importance: PDA closure by percutaneous approach is associated with a marked decrease of conventional echocardiographic parameters due to the changes in loading conditions, but no evidence of systolic dysfunction was identified by means of STE, as none of the S and SR values were below normal ranges. In the short term, contractility is enhanced in the long axis (as Long S/SR values were not statistically different before and after closure) and normalizes in the short axis (circumferential, radial and transversal S/SR decreased to normal reference range)

Preliminary Investigation of Cardiovascular–Renal Disorders in Dogs with Chronic Mitral Valve Disease

Background: Veterinary literature lacks data about cardiovascular\u2013renal disorders (CvRD) and cardiorenal-anemia syndrome (CRAS) in dogs. Hypothesis: A direct correlation exists between ACVIM class and IRIS stage; chronic kidney disease (CKD) complicates chronic mitral valve disease (CMVD) more often than does anemia in dogs. Animals: One hundred and fifty-eight client-owned dogs with CMVD. Methods: Signalment, physical examination findings, electrocardiography, thoracic radiographs, echocardiography, and blood analysis were retrospectively evaluated to assess the prevalence of CKD and anemia in dogs with CMVD and to investigate the relationships among ACVIM class, IRIS stage, and survival. Results: The prevalence of CKD and anemia in dogs with CMVD was significantly higher than in the general population of dogs. Dogs being treated for heart failure had a significantly higher prevalence of CKD than did dogs that had not received treatment. A statistically significant direct correlation was found between ACVIM class and IRIS stage. Severe heart disease, severe renal disease or both, furosemide administration, and advanced age at diagnosis of heart disease were associated with shorter survival time. Survival time of dogs affected by CvRD was statistically shorter than survival time of dogs affected by CMVD alone. Conclusion and Clinical Relevance: Chronic mitral valve disease is associated with increased prevalence of CKD and anemia in dogs. Treatment for medical management of heart failure may play a role in inducing CKD. Class of heart disease and IRIS stage were directly correlated. Cardiovascular\u2013renal disorders decrease survival time compared to the only presence of CMVD alone, whereas anemia does not play a central role in worsening heart function

Telemonitoring in Chronic Obstructive Pulmonary Disease (CHROMED). A Randomized Clinical Trial

Rationale: Early detection of COPD exacerbations using tele-monitoring of physiological variables might reduce the frequency of hospitalisation. Objectives: To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique (FOT) and cardiac parameters in older COPD patients with co-morbidities. Methods: This multicentre, randomized clinical trial recruited 312 GOLD grade II-IV COPD patients (median age 71 years [IQR:66-76], 49.6% grade II, 50.4% grade III-IV), with a history of exacerbation in the previous year and at least one non-pulmonary co-morbidity. Patients were randomised to usual care (n=158) or tele-monitoring (n=154) and followed for 9 months. All tele-monitoring patients self-assessed lung mechanics daily and in a subgroup with congestive heart failure (n=37) cardiac parameters were also monitored. An algorithm identified deterioration, triggering a telephone contact to determine appropriate interventions. Measurements and Main results: Primary outcomes were time to first hospitalisation (TTFH) and change in EQ-5D utility index score. Secondary outcomes included: rate of antibiotic/corticosteroid prescriptions, hospitalisation, CAT, PHQ-9 and MLHF questionnaire scores, quality-adjusted life years and healthcare costs. Tele-monitoring did not affect TTFH, EQ-5D utility index score, antibiotic prescriptions, hospitalization rate and questionnaire scores. In an exploratory analysis, tele-medicine was associated with fewer repeat hospitalizations (-54%, p=0.017). Conclusions: In older COPD patients with co-morbidities remote monitoring of lung function by FOT and cardiac parameters did not change TTFH and EQ-5D. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01960907

Upgraded Pulsating Heat Pipe Only For Space (U-Phos): Results of the 22nd Rexus Sounding Rocket Campaign

A large tube may still behave, to a certain extent, as a capillary in a micro-gravity environment. This very basic concept is here applied to a two-phase passive heat transfer devices in order to obtain a new family of hybrid wickless heat pipes. Indeed, a Loop Thermosyphon, which usually consists of a large tube, closed end to end in a loop, evacuated and partially filled with a working fluid and intrinsically gravity assisted, may become a capillary tube in space condition and turn its thermo-fluidic behavior into a so called Pulsating Heat Pipe (PHP), or better, a Space Pulsating Heat Pipe (SPHP). Since the objective of the present work is to experimentally demonstrate the feasibility of such a hybrid device, a SPHP has been designed, built, instrumented and tested both on ground and microgravity conditions on the 22nd ESA REXUS Sounding Rocket Campaign. Ground tests demonstrate that the device effectively work as a gravity assisted loop thermosyphon, whether the sounding rocket data clearly reveal a change in the thermal hydraulic behavior very similar to the PHP. Since a microgravity period of approximately 120s is not sufficient to reach a pseudo steady state regime, further investigation on a longer term weightless condition is mandatory

U-PHOS Project: Development of a Large Diameter Pulsating Heat Pipe Experiment on board REXUS 22

U-PHOS Project aims to analyse and characterise the behaviour of a large diameter Pulsating Heat Pipe (PHP) on board REXUS 22 sounding rocket. A PHP is a passive thermal control device consisting of a serpentine capillary tube, evacuated, partially filled with a working fluid and finally sealed. In this configuration, the liquid and vapour phases are randomly distributed in the form of liquid slugs and vapour plugs. The heat is efficiently transported by means of the self-sustained oscillatory fluid motion driven by the phase change phenomena. On ground conditions, a small diameter is required in order to obtain a confined slug flow regime. In milli-gravity conditions, buoyancy forces become less intense and the PHP diameter may be increased still maintaining the slug/plug flow configuration typical of the PHP operation. Consequently, the PHP heat power capability may be increased too. U-PHOS aims at proving that a Large Diameter PHP effectively works in milli-g conditions by characterizing its thermal response during a sounding rocket flight. The actual PHP tube is made of aluminum (3 mm inner diameter, filled with FC-72), heated at the evaporator by a compact electrical resistance, cooled at the condenser by a Phase Change Material (PCM) embedded in a metallic foam. The tube wall temperatures are recorded by means of Fibre Bragg Grating (FBG) sensors; the local fluid pressure is acquired by means of a pressure transducer. The present work intends to report the actual status of the project, focusing in particular on the experiment improvements with respect to the previous campaign

World Federation of Pediatric Imaging (WFPI) volunteer outreach through tele-reading: the pilot project in South Africa

BackgroundShortages in radiology services are estimated to affect 3.5-4.7 billion people worldwide. Teleradiology is a potential means of alleviating this shortage.ObjectiveThis paper examines the practicality and sustainability of a pilot pediatric teleradiology project at the Khayelitsha District Hospital in sub-Saharan Africa. We analyze how this World Federation of Pediatric Imaging (WFPI) program fares against the global challenges described in the current literature facing these practice types.Materials and methodsA teleradiology pilot was developed to provide coverage to the Khayelitsha District Hospital after the district pediatrician requested assistance in interpreting radiographs. This program utilized a network of WFPI volunteer pediatric radiologists, direct JPEG conversion of digital radiographic images, and an e-mail delivery system of images, referral requests and teleradiology opinion. Data were collected retrospectively from referral cards and JPEG images of radiographs, as well as from the volunteer officer database.ResultsA total of 555 referral cards and 1,106 radiographs were submitted for teleradiology opinion during the course of this pilot program; 74.6% of requests for image interpretation were chest radiographs and 14.2% of those were for the evaluation of tuberculosis. There were 40 volunteer teleradiologists from 17 countries; all spoke English, and 14 were bilingual (8 fluent in Spanish, 5 in Portuguese, and 1 in Italian).ConclusionTeleradiology is a viable option to alleviate radiologist shortages in underserved areas, but there are many challenges to designing an adequate teleradiology system. The WFPI pilot teleradiology program can be considered a successful one

Quality of Life in Chronic Ketogenic Diet Treatment : the GLUT1DS Population Perspective

BACKGROUND: Glucose transporter type 1 deficiency syndrome (GLUT1DS) is a rare, genetically determined neurological disorder, for which Ketogenic Diet (KD) represents the gold standard life-long treatment. The aim of this study is to investigate health related quality of life in a well characterized cohort of patients affected by GLUT1DS treated with KD, evaluating factors that can influence patients' and parents' quality of life perception. METHODS: This is a double center exploratory research study. A postal survey with auto-administrable questionnaires was conducted among 17 subjects (aged 3-22 years) with diagnosis of GLUT1DS, receiving a stable KD treatment for more than 1 year. The Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales was adopted. Clinical variables analyzed in relation to quality of life were frequency of epileptic seizures and movement disorder since KD introduction, presence of intellectual disability (ID), and KD ratio. RESULTS: Quality of life global scores were impaired both in parents' and children's perspectives, with a significant concordance. Taking into consideration subscales, the average was 64.17 (range 10-100) for physical functioning, 74.23 (range 30-100) for emotional functioning, 62.64 (range 10-100) for social functioning, and 56 (range 15-92) for school functioning. CONCLUSIONS: In patients with GLUT1DS the quality of life perception is comparable to that of other patients with chronic disease. In our sample, the presence of movement disorder seems to be a crucial element in quality of life perception