Search

Radio irregularity phenomenon is often considered as a shortcoming of wireless networks. In this paper, the method of using radio irregularity as an efficient human presence detection sensor in smart homes is presented. The method is mainly based on monitoring variations of the received signal strength indicator (RSSI) within the messages used for the communication between wireless smart power outlets. The radio signals used for the inter-outlets communication can be absorbed, diffracted or reflected by objects in their propagation paths. When a human enters the existing radio communication field, the variation of the signal strength at the receiver is even more expressed. Based on the detected changes and compared to the initial thresholds set during the initialization phase, the system detects human presence. The proposed solution increases user awareness and automates the power control in households, with the primary goal to contribute in residential energy savings. Compared to conventional sensor networks, this approach preserves the sensorial intelligence, simplicity and low installation costs, without the need for additional sensors integration.

Real-world data (RWD) can provide intel (real-world evidence, RWE) for research and development, as well as policy and regulatory decision-making along the full spectrum of health care. Despite calls from global regulators for international collaborations to integrate RWE into regulatory decision-making and to bridge knowledge gaps, some challenges remain. In this work, we performed an evaluation of Austrian RWD sources using a multilateral query approach, crosschecked against previously published RWD criteria and conducted direct interviews with representative RWD source samples. This article provides an overview of 73 out of 104 RWD sources in a national legislative setting where major attempts are made to enable secondary use of RWD (e.g. law on the organisation of research, "Forschungsorganisationsgesetz"). We were able to detect omnipresent challenges associated with data silos, variable standardisation efforts and governance issues. Our findings suggest a strong need for a national health data strategy and data governance framework, which should inform researchers, as well as policy- and decision-makers, to improve RWD-based research in the healthcare sector to ultimately support actual regulatory decision-making and provide strategic information for governmental health data policies., (© 2024. The Author(s).)

Real-world data (RWD) collected in routine health care processes and transformed to real-world evidence have become increasingly interesting within the research and medical communities to enhance medical research and support regulatory decision-making. Despite numerous European initiatives, there is still no cross-border consensus or guideline determining which qualities RWD must meet in order to be acceptable for decision-making within regulatory or routine clinical decision support. In the absence of guidelines defining the quality standards for RWD, an overview and first recommendations for quality criteria for RWD in pharmaceutical research and health care decision-making is needed in Austria. An Austrian multistakeholder expert group led by Gesellschaft für Pharmazeutische Medizin (Austrian Society for Pharmaceutical Medicine) met regularly; reviewed and discussed guidelines, frameworks, use cases, or viewpoints; and agreed unanimously on a set of quality criteria for RWD. This consensus statement was derived from the quality criteria for RWD to be used more effectively for medical research purposes beyond the registry-based studies discussed in the European Medicines Agency guideline for registry-based studies. This paper summarizes the recommendations for the quality criteria of RWD, which represents a minimum set of requirements. In order to future-proof registry-based studies, RWD should follow high-quality standards and be subjected to the quality assurance measures needed to underpin data quality. Furthermore, specific RWD quality aspects for individual use cases (eg, medical or pharmacoeconomic research), market authorization processes, or postmarket authorization phases have yet to be elaborated., (©Peter Klimek, Dejan Baltic, Martin Brunner, Alexander Degelsegger-Marquez, Gerhard Garhöfer, Ghazaleh Gouya-Lechner, Arnold Herzog, Bernd Jilma, Stefan Kähler, Veronika Mikl, Bernhard Mraz, Herwig Ostermann, Claas Röhl, Robert Scharinger, Tanja Stamm, Michael Strassnig, Christa Wirthumer-Hoche, Johannes Pleiner-Duxneuner. Originally published in JMIR Medical Informatics (https://medinform.jmir.org), 17.06.2022.)

Background: STEPAUT, an Austrian non-interventional study, evaluated the safety and efficacy of everolimus plus exemestane in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) recurring/progressing on/after nonsteroidal aromatase inhibitors (NSAIs) in routine clinical practice., Methods: Postmenopausal women with HR+, HER2- ABC progressing on/after NSAIs receiving everolimus plus exemestane in accordance with routine practice and the current version of Summary of Product Characteristics were eligible. Planned individual observation period corresponded to the duration of treatment until formal study end., Results: Overall, 236 patients (median age: 65 years) were enrolled at 17 sites across Austria. The median progression-free survival (mPFS) in the overall population was 9.5 months (95% confidence interval [CI]: 8.6-10.7 months). The mPFS (95% CI) in patients who received everolimus 10 and 5 mg was 9.9 months (7.3-11.5 months) and 8 months (4.7-10.7 months), respectively. The median time to progression was numerically longer in patients who had a therapy break (11.9 months, 95% CI: 10.0-14.6 months) versus those who did not have any therapy break (10.7 months, 95% CI: 8.9-12.6 months). Patients experienced grade 1 (53.7%), grade 2 (35.9%), grade 3 (9.9%), grade 4 (0.2%) adverse events (AEs). The most common AEs of any grade were stomatitis, mucositis (53.8%), rash, exanthema (29.7%), loss of appetite, nausea (28.4%)., Conclusions: Real-world safety and efficacy data from STEPAUT were consistent with results from BOLERO-2, supporting everolimus plus exemestane as a suitable treatment option for HR+, HER2- ABC recurring/progressing on/after NSAIs., Competing Interests: Declaration of competing interest GS has received grants and personal fees from Novartis during the conduct of this study; DE has received personal fees and non-financial support from Pfizer and Novartis and personal fees from Roche, Celgene, and Pierre Fabre, outside the submitted work; RB has received grants and personal fees from Novartis during the conduct of the study; personal fees from AstraZeneca, Eli Lilly, Celgene, EISAI, Daiichi, Pfizer, and Roche, outside the submitted work; GP has received honoraria from Novartis, Amgen, Roche, Pfizer, and AstraZeneca, outside the conduct of this study; EP has received honoraria from Novartis during the conduct of the study; RG has received grant and personal fees from Roche, Celgene, Merck, Astra Zeneca, Novartis, Amgen, AbbVie, BMS, MSD, Takeda, Merck, Sandoz, outside the conduct of this study; AL has received grants from Novartis during the conduct of the study; KH, MH, and BM report employment with Novartis Pharma GmbH during the conduct of this study; MG has received grants from AstraZeneca, Novartis, Pfizer, and Roche; and personal fees from Accelsiors, Amgen, AstraZeneca, Celgene, Eli-Lilly, Ipsen, Nano String Technologies, Novartis, Pfizer, and Roche, outside the submitted work. All remaining authors have declared no conflicts of interest., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)