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

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)

Das Trebnitzer Rechnungsbuch von 1523-1524 und andere Quellen zur mittelalterlichen und fruehneuzeitlichen Besitzgeschichte eines schlesischen Zisterzienserinnenklosters

Bibliothek Weltwirtschaft Kiel B 221541 / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEDEGerman

Bestandsaufnahme vorliegender Ansaetze zur Bewertung und Aggregation von Informationen im Rahmen von Umweltvertraeglichkeitspruefungen

TIB Hannover: RN 5728(1990,1)+a / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEDEGerman

MOEMS laser projector for handheld devices featuring motion compensation

Laser projection has been realized using a 2d micromechanical scanner mirror. For handheld devices it is advantageous to compensate motion. This can be realized using inertial sensors for motion detection and the implementation of a compensation algorithms. The projector must provide sufficient dynamic range for the compensation. A demo system was realized and tested succesfully

Herstellung, Struktur und Eigenschaften von C-N-Schichten. Teilvorhaben: Herstellung von C-N-Schichten durch PACVD Schlussbericht

Available from TIB Hannover: F98B1976+a / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEBundesministerium fuer Bildung, Wissenschaft, Forschung und Technologie, Bonn (Germany)DEGerman

Bestandsaufnahme vorliegender Ansaetze zur Bewertung und Aggregation von Informationen im Rahmen von Umweltvertraeglichkeitspruefungen Schlussbericht

With 278 refs., 18 tabs., 38 figs.SIGLECopy held by FIZ Karlsruhe; available from UB/TIB Hannover / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekDEGerman

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