Development and validation of a novel non-contact monitor of nocturnal respiration for identifying sleep-disordered breathing in patients with heart failure

© 2016 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. Aims: At least 50% of patients with heart failure (HF) may have sleep-disordered breathing (SDB). Overnight in-hospital polysomnography (PSG) is considered the gold standard for diagnosis, but a lack of access to such testing contributes to under-diagnosis of SDB. Therefore, there is a need for simple and reliable validated methods to aid diagnosis in patients with HF. The aim of this study was to investigate the accuracy of a non-contact type IV screening device, SleepMinderTM (SM), compared with in-hospital PSG for detecting SDB in patients with HF. Methods and results: The study included 75 adult patients with systolic HF and suspected SDB who underwent simultaneous PSG and SM recordings. An algorithm was developed from the SM signals, using digital signal processing and pattern recognition techniques to calculate the SM apnoea-hypopnoea index (AHI). This was then compared with expert-scored PSGAHI. The SM algorithm had 70% sensitivity and 89% specificity for identifying patients with clinically significant SDB (AHI ≥ 15/h). At this threshold, it had a positive likelihood ratio of 6.3 and a negative likelihood ratio of 0.16. The overall accuracy of the SMAHI algorithm was 85.8% as shown by the area under a receiver operator characteristic curve. The mean AHI with SM was 3.8/h (95% confidence interval 0.5–7.1) lower than that with PSG. Conclusions: The accuracy of the non-contact type IV screening device SM is good for clinically significant SDB in patients with systolic HF and could be considered as a simple first step in the diagnostic pathway

Dietary exposures and allergy prevention in high-risk infants

Allergic conditions in children are a prevalent health concern in Canada. The burden of disease and the societal costs of proper diagnosis and management are considerable, making the primary prevention of allergic conditions a desirable health care objective. This position statement reviews current evidence on dietary exposures and allergy prevention in infants at high risk for developing allergic conditions. It revisits previous dietary recommendations for pregnancy, breastfeeding and formula feeding, and provides an approach for introducing solid foods to high-risk infants. While there is no evidence that delaying the introduction of any specific food beyond six months of age helps to prevent allergy, the protective effect of early introduction of potentially allergenic foods (at four to six months of age) remains under investigation. Recent research appears to suggest that regularly ingesting a new, potentially allergenic food may be as important as when that food is first introduced. © Canadian Paediatric Society 2013

The evolving value assessment of cancer therapies: Results from a modified Delphi study

The move toward early detection and treatment of cancer presents challenges for value assessment using traditional endpoints. Current cancer management rarely considers the full economic and societal benefits of therapies. Our study used a modified Delphi process to develop principles for defining and assessing value of cancer therapies that aligns with the current trajectory of oncology research and reflects broader notions of value. 24 experts participated in consensus-building activities across 5 months (16 took part in structured interactions, including a survey, plenary sessions, interviews, and off-line discussions, while 8 participated in interviews). Discussion focused on: 1) which oncology-relevant endpoints should be used for assessing treatments for early-stage cancer and access decisions for early-stage treatments, and 2) the importance of additional value components and how these can be integrated in value assessments. The expert group reached consensus on 4 principles in relation to the first area (consider oncology-relevant endpoints other than overall survival; build evidence for endpoints that provide earlier indication of efficacy; develop evidence for the next generation of predictive measures; use managed entry agreements supported by ongoing evidence collection to address decision-maker evidence needs) and 3 principles in relation to the second (routinely use patient reported outcomes in value assessments; assess broad economic impact of new medicines; consider other value aspects of relevance to patients and society)

The evolving value assessment of cancer therapies: Principles from the cancer community.

Background: Oncology-relevant measures of disease and treatment support earlier detection, accelerated drug development, and inform treatment pathways. To advance access to transformative treatments for people with cancer, especially those for early-stage cancers where medical intervention has the greatest opportunity to impact the course of the disease, the cancer community identified seven principles that support the evolution of value assessment frameworks. Here we summarize the five key principles. Methods: A group of 24 cancer community experts (9 oncologists, 6 patient advocacy leaders, 1 former regulator, 6 former payers, and 4 health economists) from 14 countries came together to discuss and build consensus on oncology-relevant value principles. Over five months, the expert group engaged via surveys, virtual discussion panels, and interviews. Results: The expert group developed seven consensus principles covering two areas: oncology-relevant endpoints to assess the value of treatments; and additional important value components and how they can be integrated into value assessments. The key 5 principles were oncology-relevant endpoints assessing clinical effectiveness, including the following three items. 1) Consider oncology-relevant endpoints, other than Overall Survival (OS), with intrinsic value for decision-making e.g., Event-, Disease-, or Relapse-Free Survival. 2) Continue to build evidence for endpoints that indicate treatment efficacy earlier e.g., pathologic Complete Response. 3) Develop evidence for the next generation of predictive measures that detect and monitor disease, e.g., circulating tumor DNA and Minimal Residual Disease. Additional value components supporting patient access include the following two items. 1) Use managed entry (type of access) agreements supported by ongoing real world evidence collection to help address decision-maker (regulator and Health Technology Assessment body) evidence needs. 2) Routinely use Patient Reported Outcomes (PROs) in value assessments. Conclusions: To achieve the common goal of all cancer community stakeholders—improved outcomes for people with cancer—collaboration across the cancer community is essential to define how value is assessed, especially for early-stage cancer treatments. This is particularly important since mature OS data is not always available during initial decision-making, and decision-makers need to evolve which are the most appropriate endpoints. This supports measuring clinical impact, but also broader social, financial and ethical impact for patients, caregivers, healthcare systems, society, and the economy (not considered in this abstract). To achieve these goals, the expert group recommends: 1) increasing awareness and systematically engaging people with cancer in value assessments, 2) leveraging PROs in those assessments, and 3) further validation in clinical trials of oncology-relevant endpoints that could provide an earlier indication of clinical outcomes

Cell transformation and activation of pp60c-src by overexpression of a protein tyrosine phosphatase

Nature3596393336-339NATU

Modellversuch zur Einrichtung und Erprobung regionaler Beobachtungspraxen zwecks Erhebung umweltbezogner Gesundheitsstoerungen (MORBUS) Endbericht

Available from TIB Hannover: F97B1731+a / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEBundesministerium fuer Bildung, Wissenschaft, Forschung und Technologie, Bonn (Germany)DEGerman

Nutrition and dietary intake and their association with mortality and hospitalisation in adults with chronic kidney disease treated with haemodialysis: protocol for DIET-HD, a prospective multinational cohort study

INTRODUCTION: Adults with end-stage kidney disease (ESKD) treated with haemodialysis experience mortality of between 15% and 20% each year. Effective interventions that improve health outcomes for long-term dialysis patients remain unproven. Novel and testable determinants of health in dialysis are needed. Nutrition and dietary patterns are potential factors influencing health in other health settings that warrant exploration in multinational studies in men and women treated with dialysis. We report the protocol of the "DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated with HaemoDialysis (DIET-HD) study," a multinational prospective cohort study. DIET-HD will describe associations of nutrition and dietary patterns with major health outcomes for adults treated with dialysis in several countries.METHODS AND ANALYSIS: DIET-HD will recruit approximately 10,000 adults who have ESKD treated by clinics administered by a single dialysis provider in Argentina, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, Sweden and Turkey. Recruitment will take place between March 2014 and June 2015. The study has currently recruited 8000 participants who have completed baseline data. Nutritional intake and dietary patterns will be measured using the Global Allergy and Asthma European Network (GA(2)LEN) food frequency questionnaire. The primary dietary exposures will be n-3 and n-6 polyunsaturated fatty acid consumption. The primary outcome will be cardiovascular mortality and secondary outcomes will be all-cause mortality, infection-related mortality and hospitalisation.ETHICS AND DISSEMINATION: The study is approved by the relevant Ethics Committees in participating countries. All participants will provide written informed consent and be free to withdraw their data at any time. The findings of the study will be disseminated through peer-reviewed journals, conference presentations and to participants via regular newsletters. We expect that the DIET-HD study will inform large pragmatic trials of nutrition or dietary interventions in the setting of advanced kidney disease

Dietary Patterns and Mortality in a Multinational Cohort of Adults Receiving Hemodialysis

Clinical practice guidelines for dietary intake in hemodialysis focus on individual nutrients. Little is known about associations of dietary patterns with survival. We evaluated the associations of dietary patterns with cardiovascular and all-cause mortality among adults treated by hemodialysis