Effects of an outpatient intervention comprising nurse-led non-invasive assessments, telemedicine support and remote cardiologists' decisions in patients with heart failure (AMULET study): a randomised controlled trial.

AIM: Prevention of heart failure (HF) hospitalisations and deaths constitutes a major therapeutic aim in patients with HF. The role of telemedicine in this context remains equivocal. We investigated whether an outpatient telecare based on nurse-led non-invasive assessments supporting remote therapeutic decisions (AMULET telecare) could improve clinical outcomes in patients after an episode of acute HF during 12-month follow-up. METHODS AND RESULTS: In this prospective randomised controlled trial, patients with HF and left ventricular ejection fraction (LVEF) ≤49%, after an episode of acute HF within the last 6 months, were randomly assigned to receive either an outpatient telecare based on nurse-led non-invasive assessments (n = 300) (AMULET model) or standard care (n = 305). The primary composite outcome of unplanned HF hospitalisation or cardiovascular death occurred in 51 (17.1%) patients in the telecare group and 73 (23.9%) patients in the standard care group up to 12 months after randomization [hazard ratio (HR) 0.69, 95% confidence interval (CI) 0.48-0.99; P = 0.044]. The implementation of AMULET telecare, as compared to standard care, reduced the risk of first unplanned HF hospitalisation (HR 0.62, 95% CI 0.42-0.91; P = 0.015) as well as the risk of total unplanned HF hospitalisations (HR 0.64, 95% CI 0.41-0.99; P = 0.044).There was no difference in cardiovascular mortality between the study groups (HR 1.03, 95% CI 0.54-1.67; P = 0.930). CONCLUSIONS: AMULET telecare as compared to standard care significantly reduced the risk of HF hospitalisation or cardiovascular death during 12-month follow-up among patients with HF and LVEF ≤49% after an episode of acute HF.

Noninvasive Bioimpedance Methods From the Viewpoint of Remote Monitoring in Heart Failure.

Heart failure (HF) is a major clinical, social, and economic problem. In view of the important role of fluid overload in the pathogenesis of HF exacerbation, early detection of fluid retention is of key importance in preventing emergency admissions for this reason. However, tools for monitoring volume status that could be widely used in the home setting are still missing. The physical properties of human tissues allow for the use of impedance-based noninvasive methods, whose different modifications are studied in patients with HF for the assessment of body hydration. The aim of this paper is to present the current state of knowledge on the possible applications of these methods for remote (home-based) monitoring of patients with HF.

Rationale and design of the AMULET study: A new Model of telemedical care in patients with heart failure.

AIMS: Heart failure (HF) is characterized by high mortality and hospital readmission rates. Limited access to cardiologists restricts the application of guideline-directed, patient-tailored medical therapy. Some telemedicine solutions and novel non-invasive diagnostic tools may facilitate real-time detection of early HF decompensation symptoms, prompt initiation of appropriate treatment, and optimal management of medical resources. We describe the rationale and design of the AMULET trial, which investigates the effect of comprehensive outpatient intervention, based on individualized haemodynamic assessment and teleconsultations, on cardiovascular mortality and unplanned hospitalizations in HF patients. METHODS AND RESULTS: The AMULET trial is a multicentre, prospective, randomized, open-label, and controlled parallel group trial (ClinicalTrials.gov Identifier: NCT03476590). Six hundred and five eligible patients with HF (left ventricular ejection fraction ≤49%, at least one hospitalization due to acute HF decompensation within 6 months prior to enrolment) were randomly assigned in a 1:1 ratio to either an intervention group or a standard care group. The planned follow-up is 12 months. The AMULET interventions are performed in ambulatory care points operated by nurses, with the remote support of cardiologists. The comprehensive clinical evaluation comprises measurements of heart rate, blood pressure, body mass, thoracic fluid content, and total body water. A recommendation support module based on these objective parameters is implemented in remote therapeutic decision-making. The primary complex endpoints are cardiovascular mortality and unplanned HF hospitalization. CONCLUSIONS: The AMULET trial will provide a prospective assessment of the effect of comprehensive ambulatory intervention, based on telemedicine and haemodynamically guided therapy, on mortality and readmissions in HF patients.

Nurse-led ambulatory care supported by non-invasive haemodynamic assessment after acute heart failure decompensation.

Heart failure (HF) is characterized by frequent decompensation and an unpredictable trajectory. To prevent early hospital readmission, coordinated discharge planning and individual therapeutic approach are recommended. AIMS: We aimed to assess the effect of 1 month of ambulatory care, led by nurses and supported by non-invasive haemodynamic assessment, on the functional status, well-being, and haemodynamic status of patients post-acute HF decompensation. METHODS AND RESULTS: This study had a multicentre, prospective, and observational design and included patients with at least one hospitalization due to acute HF decompensation within 6 months prior to enrolment. The 1 month ambulatory care included three visits led by a nurse when the haemodynamic state of each patient was assessed non-invasively by impedance cardiography, including thoracic fluid content assessment. The pharmacotherapy was modified basing on haemodynamic assessment. Sixty eight of 73 recruited patients (median age = 67 years; median left ventricular ejection fraction = 30%) finished 1 month follow-up. A significant improvement was observed in both the patients' functional status as defined by New York Heart Association class (P = 0.013) and sense of well-being as evaluated by a visual analogue score (P = 0.002). The detailed patients' assessment on subsequent visits resulted in changes of pharmacotherapy in a significant percentage of patients (Visit 2 = 39% and Visit 3 = 44%). CONCLUSIONS: The proposed model of nurse-led ambulatory care for patients after acute HF decompensation, with consequent assessment of the haemodynamic profile, resulted in: (i) improvement in the functional status, (ii) improvement in the well-being, and (iii) high rate of pharmacotherapy modifications.

The Prevalence of Cardiovascular Risk Factors among Polish Soldiers: The Results from the MIL-SCORE Program.

The MIL-SCORE (Equalization of Accessibility to Cardiology Prophylaxis and Care for Professional Soldiers) program was designed to assess the prevalence and management of cardiovascular risk factors in a population of Polish soldiers. We aimed to describe the prevalence of cardiovascular risk factors in the MIL-SCORE population with respect to age. This observational cross-sectional study enrolled 6440 soldiers (97% male) who underwent a medical history, physical examination, and laboratory tests to assess cardiovascular risk. Almost half of the recruited soldiers were past or current smokers (46%). A sedentary lifestyle was reported in almost one-third of those over 40 years of age. The prevalence of hypertension in a subgroup over 50 years of age was almost 45%. However, the percentage of unsatisfactory blood pressure control was higher among soldiers below 40 years of age. The prevalence of overweight and obese soldiers increased with age and reached 58% and 27%, respectively, in those over 50 years of age. Total cholesterol was increased in over one-half of subjects, and the prevalence of abnormal low-density lipoprotein cholesterol was even higher (60%). Triglycerides were increased in 36% of soldiers, and low high-density lipoprotein cholesterol and hyperglycemia were reported in 13% and 16% of soldiers, respectively. In the >50 years of age subgroup, high and very high cardiovascular risk scores were observed in almost one-third of soldiers. The relative risk assessed in younger subgroups was moderate or high. The results from the MIL-SCORE program suggest that Polish soldiers have multiple cardiovascular risk factors and mirror trends seen in the general population. Preventive programs aimed at early cardiovascular risk assessment and modification are strongly needed in this population.

Biological, Mechanical or Physical? Conservative Treatment of Cervical Radiculopathy.

BACKGROUND: There is equivocal evidence in support of the effectiveness of each of the three co-existing approaches to conservative treatment of cervical radiculopathy (CR): biological (regenerative), mechanical (decompression) and physical (analgesic and anti-inflammatory). The aim of the study was to compare the effectiveness of the three treatment approaches in CR. MATERIAL AND METHODS: A total of 90 patients were assigned to six treatment groups. Biological treatment: 4 ultra-sound-guided periradicular injections of ACS or PRP (1 per week); Mechanical treatment: manual therapy (MT) or traction therapy (TT) - 8 ses-sions (two per week); Physical treatment: laser therapy (LT) or collagen magnetophoresis (CM) - 8 sessions (two per week). As-sessment: before therapy (W0), after completion of the treatment (W1), two months after completion (W2). Assessment tools: NRS (0-10), NDI (0-50), cross section root area in mm2 in ultrasound examination (CRA) and hand sensorimotor function test (DPT). RESULTS: The largest reduction in mean NRS, NDI and CRA values at W2 was observed with the biological treatments (NRS: ACS 71.7%, PRP 70.6%, NDI: ACS 61.5%, PRP 56.6%, CRA: ACS 23.6 %, PRP 25%). Improvement of hand sensorimotor functions was observed at both W1 and W2 only in the PRP group. The PRP group demonstrated a stronger analgesic effect than the ACS group at W1 (58.82% compared to 43.39%), but ACS therapy had the same effectiveness during the follow-up period. Other methods reduced pain and disability at W1, but further reduction of mean NRS values during the follow-up period was only evident in the CM group (32.25%), very mild in the MM (19.35%) and LT groups (18.75%), and the TT group actually demonstrated a regression (-5.58%). In 3 cases, TT exacerbated the symptoms, which resulted in termination of the therapy. CONCLUSIONS: 1. Biological treatments were more effective than mechanical and physical therapies in reducing pain, im-proving the disability index and proprioception of the hand both immediately on completion of therapy and after a follow-up period, which may suggest their regenerative properties. 2. Physical and mechanical therapies produced improvement in the above-mentioned indicators on completion of the therapy, but subsequently exerted a very slight effect during the follow-up period without evident regenerative effects; moreover, a regression of the results was actually recorded for traction therapy. 3. Caution should be paid when using traction therapy in the acute period of root oedema, due to possible signs of intolerance of the procedure and exacerbation of the discomfort.

Frequency of infections caused by ESBL-producing bacteria in a pediatric ward - single-center five-year observation.

INTRODUCTION: Infections caused by Enterobacteriaceae producing extended-spectrum ß-lactamases (ESBLs) are a serious therapeutic and clinical problem. An increasing role of ESBL(+) pathogens is observed in both community- and hospital-acquired infections. The aim of the study was to assess the incidence and the risk factors for ESBL(+) bacteria infection in a pediatric ward during a 5-year period. MATERIAL AND METHODS: The medical documentation data of patients hospitalized in the Department of Pediatrics, Pediatric Nephrology and Allergology between 2011 and 2015 were subjected to a retrospective analysis. Cases of ESBL(+) bacterial infections were analyzed in detail. RESULTS: 0.57% (46) of all the hospitalizations (8015) during the 5-year observation period in our department were caused by ESBL (+) pathogens. It constituted 8.5% of all positive microbiological cultures obtained. The analysis revealed an increasing trend in the number of ESBL (+) infections throughout the observed period. 43.5% of patients were only asymptomatic carriers. In 71.7% urinary tract structural and functional abnormalities were present. 76.1% of patients had been hospitalized previously and 60.9% had undergone urinary tract invasive procedures. CONCLUSIONS: The results confirm the rising trend of ESBL (+) infections during the observed period. ESBL (+) bacteria were isolated primarily in previously hospitalized children with particular reference to urinary tract invasive procedures during hospitalizations. Moreover, the study showed that patients with urogenital disorders and non-urinary chronic diseases are more susceptible to these priority pathogen infections.

Assessment of Cross-correlations Between Selected Macromolecules in Urine of Children with Idiopathic Hypercalciuria.

PURPOSE: The aim of the study was assessment of four selected macromolecules level: osteopontin, calgranulin, uromodulin and bikunin in fresh morning urine sample in children with nephrolithiasis in the course of idiopathic hypercalciuria. MATERIALS AND METHODS: The study included 90 subjects aged from 12 months to 18 years. The study group comprised 57 subjects- children with urinary tract lithiasis in the course of idiopathic hypercalciuria and the control group - 33 healthy children with no history of urolithiasis. Determinations of osteopontin, calgranulin, uromodulin and bikunin levels in the first morning urine were performed. RESULTS: The study group had a significantly decreased osteopontin excretion and significantly increased bikuninexcretion, and increased, however statistically nonsignificant, calgranulin excretion in comparison with the control group. Uromodulin excretion did not differ between groups. In both groups a statistically significant positive correlation was observed between uromodulin and bikunin levels. CONCLUSION: Children with urinary tract lithiasis in the course of idiopathic hypercalciuria reveal a different distribution of the study proteins than a healthy population.

Role of Nitric Oxide Pathway in Development and Progression of Chronic Kidney Disease in Rats Sensitive and Resistant to its Occurrence in an Experimental Model of 5/6 Nephrectomy.

BACKGROUND Understanding the mechanisms conditioning development of chronic kidney disease (CKD) is still a challenge. The aim of this study was to evaluate the activity of the intrarenal nitric oxide (NO) pathway in the context of sensitivity or resistance of different animal strains to the development and degree of renal failure. MATERIAL AND METHODS Two rat strains were used: Wistar (WR) and Sprague-Dawley rats (SDR) in a model of CKD - 5/6 nephrectomy. We assessed parameters of renal failure and expression of nitric oxide synthase (NOS) isoforms in renal cortex and medulla. RESULTS We did not observe renal failure in WR, and CKD developed in SDR with increase of creatinine and urea concentration as well as decrease of diuresis and glomerular filtration. In the renal cortex, baseline expression of NOS2 was higher in WR than in SDR. 5/6 nephrectomy resulted in reduction of NOS2 in both strains and NOS3 in WR. In the renal medulla, baseline NOS2 expression was higher in SDR, and nephrectomy resulted in its decrease only in SDR. Although baseline NOS3 expression was higher in SDR, the NOS3 expression after nephrectomy was higher in WR rats. CONCLUSIONS In model of CKD - 5/6 nephrectomy, SDR proved to be sensitive and WR resistant to development of CKD. The intrarenal activity of the nitric oxide pathway was the factor that differentiated both strains. This mechanism may be responsible for insensitivity of WR to development of renal failure in this model of CKD.

Evaluation of selected immunological parameters and the concentration of vitamin D in children with asthma. Case-control study.

Due to the increased incidence of allergic diseases and emerging effects of unsatisfactory control of asthma, new mechanisms for supervising the immune system should be searched. The aim of the study was to analyze the percentage of CD3, CD4, CD8, CD19, CD16/56, NKT, CD3 anti-HLADR3 and Foxp3 regulatory lymphocytes in patients with asthma. Additionally the correlation between immune parameters, severity of asthma and serum concentration of vitamin D was performed. 25 children diagnosed with asthma were enrolled. Disease severity was assessed with the Asthma Control Test (ACT) and spirometry. The control group consisted of 15 healthy children. Venous blood from each patient was collected on EDTA or on "clott". Phenotypes of lymphocytes were evaluated by flow cytometry. Vitamin D concentration was assessed by chemiluminescent immunoassay (CLIA) technology. There was a significant decrease in the percentage of T regulatory cells (p < 0.006) in children with asthma compared to the control group. There were no significant differences in the other investigated immunological parameters. In addition, in asthma group statistically significant decreased of vitamin D concentration (p < 0.04) was observed. There were also no significant correlations between vitamin D3 concentration and the course of asthma or percentage of regulatory cells. The results confirmed the role of regulatory T cells in the pathogenesis of asthma. Effects of vitamin D on the severity of the disease has not been proven.

Functional Assessment of Synoptic Pathology Reporting for Ovarian Cancer.

BACKGROUND: Ovarian cancer has one of the highest death/incidence rates and is commonly diagnosed at an advanced stage. In the recent WHO classification, new histotypes were classified which respond differently to chemotherapy. The e-standardized synoptic cancer pathology reports offer the clinicians essential and reliable information. The aim of our project was to develop an e-template for the standardized synoptic pathology reporting of ovarian carcinoma [based on the checklist of the College of American Pathologists (CAP) and the recent WHO/FIGO classification] to introduce a uniform and improved quality of cancer pathology reports. A functional and qualitative evaluation of the synoptic reporting was performed. METHODS: An indispensable module for e-synoptic reporting was developed and integrated into the Hospital Information System (HIS). The electronic pathology system used a standardized structure with drop-down lists of defined elements to ensure completeness and consistency of reporting practices with the required guidelines. All ovarian cancer pathology reports (partial and final) with the corresponding glass slides selected from a 1-year current workflow were revised for the standard structured reports, and 42 tumors [13 borderline tumors and 29 carcinomas (mainly serous)] were included in the study. RESULTS: Analysis of the reports for completeness against the CAP checklist standard showed a lack of pTNM staging in 80% of the partial or final unstructured reports; ICD-O coding was missing in 83%. Much less frequently missed or unstated data were: ovarian capsule infiltration, angioinvasion and implant evaluation. The e-records of ovarian tumors were supplemented with digital macro- and micro-images and whole-slide images. CONCLUSIONS: The e-module developed for synoptic ovarian cancer pathology reporting was easily incorporated into HIS.CGM CliniNet and facilitated comprehensive reporting; it also provided open access to the database for concerned recipients. The e-synoptic pathology reports appeared more accurate, clear and conclusive than traditional narrative reports. Standardizing structured reporting and electronic tools allows open access and downstream utilization of pathology data for clinicians and tumor registries.

Effectiveness evaluation for short-term group pre-deployment VR computer-assisted stress inoculation training provided to Polish ISAF soldiers.

The goal of this study was to assess effectiveness of a short collective stress inoculation training (SIT) conducted according to the methodology of the Virtual Reality Medical Center of San Diego (Training of Physiological Control Exposure to Virtual Stressor while Maintaining Physiological Control). The results obtained indicate a short-term effectiveness of the training as a method of tension reduction. However, in the long-term perspective these results are ambiguous and they suggest a need of further research. In order to extend the analysis effects of temperamental factors on training effectiveness was presented.

Accuracy of a remote quantitative image analysis in the whole slide images.

The rationale for choosing a remote quantitative method supporting a diagnostic decision requires some empirical studies and knowledge on scenarios including valid telepathology standards. The tumours of the central nervous system [CNS] are graded on the base of the morphological features and the Ki-67 labelling Index [Ki-67 LI]. Various methods have been applied for Ki-67 LI estimation. Recently we have introduced the Computerized Analysis of Medical Images [CAMI] software for an automated Ki-67 LI counting in the digital images. Aims of our study was to explore the accuracy and reliability of a remote assessment of Ki-67 LI with CAMI software applied to the whole slide images [WSI]. The WSI representing CNS tumours: 18 meningiomas and 10 oligodendrogliomas were stored on the server of the Warsaw University of Technology. The digital copies of entire glass slides were created automatically by the Aperio ScanScope CS with objective 20x or 40x. Aperio's Image Scope software provided functionality for a remote viewing of WSI. The Ki-67 LI assessment was carried on within 2 out of 20 selected fields of view (objective 40x) representing the highest labelling areas in each WSI. The Ki-67 LI counting was performed by 3 various methods: 1) the manual reading in the light microscope - LM, 2) the automated counting with CAMI software on the digital images - DI , and 3) the remote quantitation on the WSIs - as WSI method. The quality of WSIs and technical efficiency of the on-line system were analysed. The comparative statistical analysis was performed for the results obtained by 3 methods of Ki-67 LI counting. The preliminary analysis showed that in 18% of WSI the results of Ki-67 LI differed from those obtained in other 2 methods of counting when the quality of the glass slides was below the standard range. The results of our investigations indicate that the remote automated Ki-67 LI analysis performed with the CAMI algorithm on the whole slide images of meningiomas and oligodendrogliomas could be successfully used as an alternative method to the manual reading as well as to the digital images quantitation with CAMI software. According to our observation a need of a remote supervision/consultation and training for the effective use of remote quantitative analysis of WSI is necessary.

[The usefulness of thermography in the diagnostics of dry eye syndrome]. / Przydatnosc termografii w diagnostyce zespolu suchego oka.

PURPOSE: The aim of the study was to evaluate corneal temperature in patients with dry eye syndrome, and in normal subjects by measuring with infrared radiation thermography. MATERIAL AND METHODS: Each eye of 9 patients with dry eye syndrome and each eye of 13 normal subjects, were evaluated in this study. The corneal surface temperature was measured during 15 seconds after opening the eye. RESULTS: Mean corneal temperature was lower in the dry eye syndrome patients compared with the control group. Decrease in time of mean corneal temperature in patients with dry eye syndrome, was lesser than in the control group. CONCLUSIONS: The study shows the usefulness of thermography in the diagnosis of dry eye syndrome.