Effect of a reduction in glomerular filtration rate after nephrectomy on arterial stiffness and central hemodynamics: rationale and design of the EARNEST study

Background: There is strong evidence of an association between chronic kidney disease (CKD) and cardiovascular disease. To date, however, proof that a reduction in glomerular filtration rate (GFR) is a causative factor in cardiovascular disease is lacking. Kidney donors comprise a highly screened population without risk factors such as diabetes and inflammation, which invariably confound the association between CKD and cardiovascular disease. There is strong evidence that increased arterial stiffness and left ventricular hypertrophy and fibrosis, rather than atherosclerotic disease, mediate the adverse cardiovascular effects of CKD. The expanding practice of live kidney donation provides a unique opportunity to study the cardiovascular effects of an isolated reduction in GFR in a prospective fashion. At the same time, the proposed study will address ongoing safety concerns that persist because most longitudinal outcome studies have been undertaken at single centers and compared donor cohorts with an inappropriately selected control group.<p></p> Hypotheses: The reduction in GFR accompanying uninephrectomy causes (1) a pressure-independent increase in aortic stiffness (aortic pulse wave velocity) and (2) an increase in peripheral and central blood pressure.<p></p> Methods: This is a prospective, multicenter, longitudinal, parallel group study of 440 living kidney donors and 440 healthy controls. All controls will be eligible for living kidney donation using current UK transplant criteria. Investigations will be performed at baseline and repeated at 12 months in the first instance. These include measurement of arterial stiffness using applanation tonometry to determine pulse wave velocity and pulse wave analysis, office blood pressure, 24-hour ambulatory blood pressure monitoring, and a series of biomarkers for cardiovascular and bone mineral disease.<p></p> Conclusions: These data will prove valuable by characterizing the direction of causality between cardiovascular and renal disease. This should help inform whether targeting reduced GFR alongside more traditional cardiovascular risk factors is warranted. In addition, this study will contribute important safety data on living kidney donors by providing a longitudinal assessment of well-validated surrogate markers of cardiovascular disease, namely, blood pressure and arterial stiffness. If any adverse effects are detected, these may be potentially reversed with the early introduction of targeted therapy. This should ensure that kidney donors do not come to long-term harm and thereby preserve the ongoing expansion of the living donor transplant program.<p></p&gt

REveAL™ and CARElink™ (Real Care): Minimising the time taken to achieve a diagnosis in the implantable loop recorder population

Introduction Syncope accounts for ≈ 2.7/1000 population/year of presentations to UK healthcare, a figure believed to be underestimated by up to 30% due to misdiagnosis. For some patients the cause of their episode/s may remain unexplained. The implantable loop recorder (ILR) is effective for diagnosis of syncope and palpitations, with UK and European guidelines advising its use if symptoms are infrequent. However current follow-up regimes can lead to a slow diagnostic pathway for patients. Remote monitoring technology allows patients to send their ILR data to their clinic Research Questions 1) Does remote monitoring of ILRs reduce time to diagnosis and/or increase diagnostic yield? 2) What is the impact of remote monitoring on logged events requiring analysis? Method New ILR patients at a single implanting centre were recruited. Following informed consent, they were randomised into control or experimental groups. Patients in the control group were reviewed in the conventional manner with routine 6 monthly follow-ups plus additional ad hoc checks if symptoms occurred. Patients in the experimental group were asked to send transmissions fortnightly or following a symptom. All recordings were reviewed and classified as true or false events according to pre-defined criteria. Significant true event ECGs were reviewed blindly by a cardiologist. All data were verified by two physiologists or a physiologist and a cardiologist prior to analysis. The primary outcome variable was median time to clinical diagnosis. Results 37 patients were randomised, 19 to the control and 18 to the experimental group. The control group comprised 11 males and 8 females with a median age of 60 (36-86) years. The experimental group comprised 10 males and 8 females, median age 58 (36-84) years. Mann-Whitney U testing showed no significant differences in group demographics. Following randomisation 5526 events were logged, 1264 in the control and 4262 in the experimental group. 28 (76%) of patients had a true event, which led to a diagnosis in 23 (67%) of patients. There were 13 patients with true events and 10 diagnoses in the experimental group, with 15 true events and 13 diagnoses in the control group. Asystole was the most common event that led to a diagnosis, accounting for 35% of diagnoses. Kaplan-Meier analysis was used to assess the primary outcomes of time from event to follow-up, and time to clinical diagnosis. Compared to the control group, the median time from event to follow-up was reduced from 3 to 1 week (p=0.004). Median time to diagnosis was reduced from 13 to 6 weeks (p=0.049) when remote monitoring was used. Conclusion In patients with ILR, remote monitoring significantly reduced diagnostic delay although the overall diagnostic yield was not increased. However remote monitoring resulted in a three-fold increase in logged events that required analysis with only 1 in 328 proving to be true events: this will have significant resource implications

The holistic perspective of the INCISIVE Project: artificial intelligence in screening mammography

Finding new ways to cost-effectively facilitate population screening and improve cancer diagnoses at an early stage supported by data-driven AI models provides unprecedented opportunities to reduce cancer related mortality. This work presents the INCISIVE project initiative towards enhancing AI solutions for health imaging by unifying, harmonizing, and securely sharing scattered cancer-related data to ensure large datasets which are critically needed to develop and evaluate trustworthy AI models. The adopted solutions of the INCISIVE project have been outlined in terms of data collection, harmonization, data sharing, and federated data storage in compliance with legal, ethical, and FAIR principles. Experiences and examples feature breast cancer data integration and mammography collection, indicating the current progress, challenges, and future directions.This research received funding mainly from the European Union’s Horizon 2020 research and innovation program under grant agreement no 952179. It was also partially funded by the Ministry of Economy, Industry, and Competitiveness of Spain under contracts PID2019-107255GB and 2017-SGR-1414.Peer ReviewedArticle signat per 30 autors/es: Ivan Lazic (1), Ferran Agullo (2), Susanna Ausso (3), Bruno Alves (4), Caroline Barelle (4), Josep Ll. Berral (2), Paschalis Bizopoulos (5), Oana Bunduc (6), Ioanna Chouvarda (7), Didier Dominguez (3), Dimitrios Filos (7), Alberto Gutierrez-Torre (2), Iman Hesso (8), Nikša Jakovljević (1), Reem Kayyali (8), Magdalena Kogut-Czarkowska (9), Alexandra Kosvyra (7), Antonios Lalas (5) , Maria Lavdaniti (10,11), Tatjana Loncar-Turukalo (1),Sara Martinez-Alabart (3), Nassos Michas (4,12), Shereen Nabhani-Gebara (8), Andreas Raptopoulos (6), Yiannis Roussakis (13), Evangelia Stalika (7,11), Chrysostomos Symvoulidis (6,14), Olga Tsave (7), Konstantinos Votis (5) Andreas Charalambous (15) / (1) Faculty of Technical Sciences, University of Novi Sad, 21000 Novi Sad, Serbia; (2) Barcelona Supercomputing Center, 08034 Barcelona, Spain; (3) Fundació TIC Salut Social, Ministry of Health of Catalonia, 08005 Barcelona, Spain; (4) European Dynamics, 1466 Luxembourg, Luxembourg; (5) Centre for Research and Technology Hellas, 57001 Thessaloniki, Greece; (6) Telesto IoT Solutions, London N7 7PX, UK: (7) School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece; (8) Department of Pharmacy, Kingston University London, London KT1 2EE, UK; (9) Timelex BV/SRL, 1000 Brussels, Belgium; (10) Nursing Department, International Hellenic University, 57400 Thessaloniki, Greece; (11) Hellenic Cancer Society, 11521 Athens, Greece; (12) European Dynamics, 15124 Athens, Greece; (13) German Oncology Center, Department of Medical Physics, Limassol 4108, Cyprus; (14) Department of Digital Systems, University of Piraeus, 18534 Piraeus, Greece; (15) Department of Nursing, Cyprus University of Technology, Limassol 3036, CyprusPostprint (published version

Randomised controlled trials of complex interventions and large-scale transformation of services

Complex interventions and large-scale transformations of services are necessary to meet the health-care challenges of the 21st century. However, the evaluation of these types of interventions is challenging and requires methodological development. Innovations such as cluster randomised controlled trials, stepped-wedge designs, and non-randomised evaluations provide options to meet the needs of decision-makers. Adoption of theory and logic models can help clarify causal assumptions, and process evaluation can assist in understanding delivery in context. Issues of implementation must also be considered throughout intervention design and evaluation to ensure that results can be scaled for population benefit. Relevance requires evaluations conducted under real-world conditions, which in turn requires a pragmatic attitude to design. The increasing complexity of interventions and evaluations threatens the ability of researchers to meet the needs of decision-makers for rapid results. Improvements in efficiency are thus crucial, with electronic health records offering significant potential

Well-being of Canadian Armed Forces Veterans and Spouses of Veterans during the COVID-19 Pandemic: Protocol for a Prospective Longitudinal Survey

Background: The COVID-19 pandemic has resulted in significant changes to everyday life, including social distancing mandates, changes to health care, and a heightened risk of infection. Previous research has shown that Canadian Armed Forces (CAF) veterans are at higher risk of developing mental and physical health conditions. Veterans and their families may face unique social challenges that can compound with pandemic-related disruptions to negatively impact well-being. Objective: This study aims to longitudinally characterize the mental health of CAF veterans and spouses of CAF veterans throughout the pandemic and to understand the dynamic influences of pandemic-related stressors on psychological health over time. Methods: We employed a prospective longitudinal panel design using an online data collection platform. Study participation was open to all CAF veterans and spouses of CAF veterans residing in Canada. Participants were asked to complete a comprehensive battery of assessments representing psychological well-being, chronic pain, health care access patterns, physical environment, employment, social integration, and adjustment to pandemic-related lifestyle changes. Follow-up assessments were conducted every 3 months over an 18-month period. This study was approved by the Western University Health Sciences and Lawson Health Research Institute Research Ethics Boards. Results: Baseline data were collected between July 2020 and February 2021. There were 3 population segments that participated in the study: 1047 veterans, 366 spouses of veterans, and 125 veterans who are also spouses of veterans completed baseline data collection. As of November 2021, data collection is ongoing, with participants completing the 9-or 12-month follow-up surveys depending on their date of self-enrollment. Data collection across all time points will be complete in September 2022. Conclusions: This longitudinal survey is unique in its comprehensive assessment of domains relevant to veterans and spouses of veterans during the COVID-19 pandemic, ranging from occupational, demographic, social, mental, and physical domains, to perceptions and experiences with health care treatments and access. The results of this study will be used to inform policy for veteran and veteran family support, and to best prepare for similar emergencies should they occur in the future

Aerospace medicine and biology: A continuing bibliography with indexes

This bibliography lists 138 reports, articles, and other documents introduced into the NASA scientific and technical information system in Jun. 1980