103 research outputs found

    Communication and patient safety in gynecology and obstetrics - study protocol of an intervention study.

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    BACKGROUND: Patient safety is a key target in public health, health services and medicine. Communication between all parties involved in gynecology and obstetrics (clinical staff/professionals, expectant mothers/patients and their partners, close relatives or friends providing social support) should be improved to ensure patient safety, including the avoidance of preventable adverse events (pAEs). Therefore, interventions including an app will be developed in this project through a participatory approach integrating two theoretical models. The interventions will be designed to support participants in their communication with each other and to overcome difficulties in everyday hospital life. The aim is to foster effective communication in order to reduce the frequency of pAEs. If communication is improved, clinical staff should show an increase in work satisfaction and patients should show an increase in patient satisfaction. METHODS: The study will take place in two maternity clinics in Germany. In line with previous studies of complex interventions, it is divided into three interdependent phases. Each phase provides its own methods and data. Phase 1: Needs assessment and a training for staff (n = 140) tested in a pre-experimental study with a pre/post-design. Phase 2: Assessment of communication training for patients and their social support providers (n = 423) in a randomized controlled study. Phase 3: Assessment of an app supporting the communication between staff, patients, and their social support providers (n = 423) in a case-control study. The primary outcome is improvement of communication competencies. A range of other implementation outcomes will also be assessed (i.e. pAEs, patient/treatment satisfaction, work satisfaction, safety culture, training-related outcomes). DISCUSSION: This is the first large intervention study on communication and patient safety in gynecology and obstetrics integrating two theoretical models that have not been applied to this setting. It is expected that the interventions, including the app, will improve communication practice which is linked to a lower probability of pAEs. The app will offer an effective and inexpensive way to promote effective communication independent of users' motivation. Insights gained from this study can inform other patient safety interventions and health policy developments. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03855735; date of registration: February 27, 2019

    Evolution of the geomagnetic daily variation at Tatuoca, Brazil, from 1957 to 2019: a transition from Sq to EEJ

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    The magnetic equator in the Brazilian region has moved over 1,100 km northward since 1957, passing the geomagnetic observatory Tatuoca (TTB), in northern Brazil, around 2013. We recovered and processed TTB hourly mean values of the geomagnetic field horizontal (H) component from 1957 until 2019, allowing the investigation of long‐term changes in the daily variation due to the influence of secular variation, solar activity, season, and lunar phase. The H day‐to‐day variability and the occurrence of the counter electrojet at TTB were also investigated. Until the 1990s, ionospheric solar quiet currents dominated the quiet‐time daily variation at TTB. After 2000, the magnitude of the daily variation became appreciably greater due to the equatorial electrojet (EEJ) contribution. The H seasonal and day‐to‐day variability increased as the magnetic equator approached, but their amplitudes normalized to the average daily variation remained at similar levels. Meanwhile, the amplitude of the lunar variation, normalized in the same way, increased from 5% to 12%. Within the EEJ region, the occurrence rate of the morning counter electrojet (MCEJ) increased with proximity to the magnetic equator, while the afternoon counter electrojet (ACEJ) did not. EEJ currents derived from CHAMP and Swarm satellite data revealed that the MCEJ rate varies with magnetic latitude within the EEJ region while the ACEJ rate is largely constant. Simulations with the Thermosphere‐Ionosphere‐Electrodynamics General Circulation Model based on different geomagnetic main field configurations suggest that long‐term changes in the geomagnetic daily variation at TTB can be attributed to the main field secular variation

    Virtual slides in peer reviewed, open access medical publication

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    <p>Abstract</p> <p>Background</p> <p>Application of virtual slides (VS), the digitalization of complete glass slides, is in its infancy to be implemented in routine diagnostic surgical pathology and to issues that are related to tissue-based diagnosis, such as education and scientific publication.</p> <p>Approach</p> <p>Electronic publication in Pathology offers new features of scientific communication in pathology that cannot be obtained by conventional paper based journals. Most of these features are based upon completely open or partly directed interaction between the reader and the system that distributes the article. One of these interactions can be applied to microscopic images allowing the reader to navigate and magnify the presented images. VS and interactive Virtual Microscopy (VM) are a tool to increase the scientific value of microscopic images.</p> <p>Technology and Performance</p> <p>The open access journal Diagnostic Pathology <url>http://www.diagnosticpathology.org</url> has existed for about five years. It is a peer reviewed journal that publishes all types of scientific contributions, including original scientific work, case reports and review articles. In addition to digitized still images the authors of appropriate articles are requested to submit the underlying glass slides to an institution (DiagnomX.eu, and Leica.com) for digitalization and documentation. The images are stored in a separate image data bank which is adequately linked to the article. The normal review process is not involved. Both processes (peer review and VS acquisition) are performed contemporaneously in order to minimize a potential publication delay. VS are not provided with a DOI index (digital object identifier). The first articles that include VS were published in March 2011.</p> <p>Results and Perspectives</p> <p>Several logistic constraints had to be overcome until the first articles including VS could be published. Step by step an automated acquisition and distribution system had to be implemented to the corresponding article. The acceptance of VS by the reader is high as well as by the authors. Of specific value are the increased confidence to and reputation of authors as well as the presented information to the reader. Additional associated functions such as access to author-owned related image collections, reader-controlled automated image measurements and image transformations are in preparation.</p> <p>Virtual Slides</p> <p>The virtual slide(s) for this article can be found here: <url>http://www.diagnosticpathology.diagnomx.eu/vs/1232133347629819</url>.</p

    Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

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    Pitfalls in assessing stromal tumor infiltrating lymphocytes (sTILs) in breast cancer

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    Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

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    Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting

    Report on computational assessment of Tumor Infiltrating Lymphocytes from the International Immuno-Oncology Biomarker Working Group.

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    Funder: U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI)Funder: National Center for Research Resources under award number 1 C06 RR12463-01, VA Merit Review Award IBX004121A from the United States Department of Veterans Affairs Biomedical Laboratory Research and Development Service, the DOD Prostate Cancer Idea Development Award (W81XWH-15-1-0558), the DOD Lung Cancer Investigator-Initiated Translational Research Award (W81XWH-18-1-0440), the DOD Peer Reviewed Cancer Research Program (W81XWH-16-1-0329), the Ohio Third Frontier Technology Validation Fund, the Wallace H. Coulter Foundation Program in the Department of Biomedical Engineering and the Clinical and Translational Science Award Program (CTSA) at Case Western Reserve University.Funder: Susan G Komen Foundation (CCR CCR18547966) and a Young Investigator Grant from the Breast Cancer Alliance.Funder: The Canadian Cancer SocietyFunder: Breast Cancer Research Foundation (BCRF), Grant No. 17-194Assessment of tumor-infiltrating lymphocytes (TILs) is increasingly recognized as an integral part of the prognostic workflow in triple-negative (TNBC) and HER2-positive breast cancer, as well as many other solid tumors. This recognition has come about thanks to standardized visual reporting guidelines, which helped to reduce inter-reader variability. Now, there are ripe opportunities to employ computational methods that extract spatio-morphologic predictive features, enabling computer-aided diagnostics. We detail the benefits of computational TILs assessment, the readiness of TILs scoring for computational assessment, and outline considerations for overcoming key barriers to clinical translation in this arena. Specifically, we discuss: 1. ensuring computational workflows closely capture visual guidelines and standards; 2. challenges and thoughts standards for assessment of algorithms including training, preanalytical, analytical, and clinical validation; 3. perspectives on how to realize the potential of machine learning models and to overcome the perceptual and practical limits of visual scoring
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