scholarly journals P105 Ambulatory study center at the University of Basel Children’s Hospital (UKBB)

2019 ◽  
Vol 104 (6) ◽  
pp. e61.2-e62
Author(s):  
C Werner ◽  
R Santoro ◽  
J Bielicki
Keyword(s):  
Clinical Study ◽  
Clinical Research ◽  
Clinical Studies ◽  
Quality Management System ◽  
Full Range ◽  
The United States ◽  
University Hospital ◽  
Specialized Team ◽  
The University ◽  
Study Center

BackgroundMany drugs authorized in Europe and the United States are inadequately studied in children. SwissPedNet Funding has boosted the development of specialized and professional pediatric centers for clinical studies in Switzerland tasked with executing compliant, reliable and family-centered clinical research. The University of Basel Children`s Hospital (UKBB) is one of the pediatric clinical study centers.MethodsThe Department for Clinical Research in Basel consists of the study center for adults at University Hospital Basel (USB) and the Ambulatory Study Center (ASZ) focusing on pediatric studies at the UKBB. The latter was established in 2015, and consists of a specialized team, including a medical director, medical coordinator, medical specialists in pediatrics as well as a team of study nurses.The ASZ supports and promotes clinical studies with and for infants and children for external and internal sponsors in various therapeutic areas such as oncology, cardiology, pneumology, nephrology, neuropediatrics, orthopaedics and infectious diseases. The full range of activities for executing the approved clinical study protocol can be offered, including planning, implementation, budgeting, coordinating, monitoring and archiving as well as collaboration with all required hospital departments.ResultsUp to now, the ASZ has enrolled around 600 children in clinical trials, with 6 studies completed and 12 studies ongoing. A comprehensive Quality Management system was established and SOPs were jointly created with the adult study center. A digital clinical study request form is available for sponsors via the website.ConclusionWe see an increased demand for pediatric clinical studies across all age ranges and therapeutic areas. We envision a center of excellence with a pool of fully trained study nurses to accommodate and centrally organize all pediatric studies in the UKBB. Parent engagement and patient inclusion is one critical step to further improving healthcare for pediatric patients through highest quality clinical research.Disclosure(s)Nothing to disclose

User Evaluation of an Integrated Medical Workstation for Clinical Data Analysis

1993 ◽  
Vol 32 (05) ◽  
pp. 365-372 ◽  
Author(s):  
T. Timmeis ◽  
J. H. van Bemmel ◽  
E. M. van Mulligen
Keyword(s):  
Data Analysis ◽  
Clinical Research ◽  
Clinical Data ◽  
University Hospital ◽  
User Evaluation ◽  
Scientific Staff ◽  
Medical Institutions ◽  
Clinical Data Analysis ◽  
Research Problems ◽  
The University

AbstractResults are presented of the user evaluation of an integrated medical workstation for support of clinical research. Twenty-seven users were recruited from medical and scientific staff of the University Hospital Dijkzigt, the Faculty of Medicine of the Erasmus University Rotterdam, and from other Dutch medical institutions; and all were given a written, self-contained tutorial. Subsequently, an experiment was done in which six clinical data analysis problems had to be solved and an evaluation form was filled out. The aim of this user evaluation was to obtain insight in the benefits of integration for support of clinical data analysis for clinicians and biomedical researchers. The problems were divided into two sets, with gradually more complex problems. In the first set users were guided in a stepwise fashion to solve the problems. In the second set each stepwise problem had an open counterpart. During the evaluation, the workstation continuously recorded the user’s actions. From these results significant differences became apparent between clinicians and non-clinicians for the correctness (means 54% and 81%, respectively, p = 0.04), completeness (means 64% and 88%, respectively, p = 0.01), and number of problems solved (means 67% and 90%, respectively, p = 0.02). These differences were absent for the stepwise problems. Physicians tend to skip more problems than biomedical researchers. No statistically significant differences were found between users with and without clinical data analysis experience, for correctness (means 74% and 72%, respectively, p = 0.95), and completeness (means 82% and 79%, respectively, p = 0.40). It appeared that various clinical research problems can be solved easily with support of the workstation; the results of this experiment can be used as guidance for the development of the successor of this prototype workstation and serve as a reference for the assessment of next versions.

Commentary: An African Perspective on the Doha Round Negotiations

2005 ◽  
Vol 5 (4) ◽  
pp. 1850076
Author(s):  
Kwame Bawuah-Edusei
Keyword(s):  
Medical Center ◽  
The United States ◽  
University Hospital ◽  
Community Leader ◽  
Washington Dc ◽  
Medical Sciences ◽  
Energy Company ◽  
Army Hospital ◽  
Howard University ◽  
The University

An African commentary on the Doha Development Round. Kwame Bawuah-Edusei is Ambassador of Ghana to Switzerland and Austria and Permanent Representative of Ghana to the UN offices and international organizations in Geneva, including the WTO. He obtained his MD degree in 1982 at the University of Science and Technology, School of Medical Sciences, Kumasi Ghana, worked in Ghana for two years, and later studied in the United States. He specialized in Family Medicine at Howard University Hospital, Washington DC, and worked as a physician for the Dewitt Army Hospital in Fort Belvoir, Virginia. He subsequently practiced at Educe Medical Center in Alexandria, Virginia. During this period he was active in promoting business in his native Ghana and extensively involved in humanitarian work in the deprived Northern part of his country. He became a community leader in North America and was instrumental in institutionalizing democracy in Ghana. He became a Director of the EO group, an energy Company, and President of Educe Incorporated in Ghana.

scholarly journals Virtual reality exercise to help COVID patients with refractory breathlessness

2021 ◽  
Author(s):  
Sophie J A Betka ◽  
Oliver A Kannape ◽  
Jemina Fasola ◽  
Florian Lance ◽  
Sylvain Cardin ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Clinical Study ◽  
Sequence Data ◽  
University Hospital ◽  
Breathing Patterns ◽  
Experimental Conditions ◽  
Asynchronous Control ◽  
Respiratory Feedback ◽  
Control Feedback ◽  
The University

Background: Immersive virtual reality (iVR)-based digital therapeutics (DTx) are gaining clinical attention in the field of pain management. Based on known analogy between chronic pain and dyspnea, we investigated the effects of visual respiratory feedback in iVR, on refractory breathlessness in patients recovering from severe COVID-19 pneumonia. Methods: We performed a controlled, randomized, single-blind, cross-over clinical study to evaluate an iVR-based intervention to alleviate refractory breathlessness in patients recovering from COVID-19 pneumonia. The single-site study was conducted at the university hospital of Geneva, Switzerland. Patients reported refractory breathlessness (≥5 on a 10-point dyspnea scale) and had a MoCA score of ≥24. Cross-over groups were randomly assigned, concealed from the referring clinician. Participants received synchronous (intervention) or asynchronous (control) feedback of their breathing, embodied via a gender-matched avatar in iVR. Prior to the first exposure and following both experimental conditions, patients completed questionnaires. Breathing patterns were captured continuously. The COVVR clinical study is registered with ClinicalTrials.gov (NCT04844567) and is now closed. Findings: Study enrollment was open between November 2020 and April 2021. A total of 26 patients (27% women; age: mean=57, SD±12) were enrolled; 14 patients were randomly assigned to the ″synchronous/asynchronous″ sequence, 12 to the ″asynchronous/synchronous″ sequence. Data was available for all except two (7.7%) of 26 patients. The mean rating of breathing comfort was 0.1 at baseline, 0.8±1.8 for asynchronous, and 1.3±1.4 synchronous feedback (estimated difference of 0.5 (95%CI 0.05 to 1.04; p<0.05) between iVR conditions). Of all patients, 91.2% were satisfied with the intervention (1.8±1.6, t=5.201, p<0.0001, 95%CI 1.173 to inf) and 66.7% perceived it as beneficial for their breathing (0.7±1.9, t=1.806, p<0.05, 95%CI 0.036 to inf). No adverse events were reported. Interpretation: Based on these findings, we propose that our iVR-based DTx is a feasible and safe neuro-rehabilitation tool that improves breathing comfort in patients recovering from severe COVID-19 infection. More research is needed to generalize this tool in other groups of patients suffering from refractory breathlessness.

Journey across epidemiology’s third variables: an anesthesiologist’s guide for successfully navigating confounding, mediation, and effect modification

2021 ◽  
pp. rapm-2020-101984 ◽  
Author(s):  
Joshua Levy ◽  
Rebecca Lebeaux ◽  
Brock Christensen ◽  
Tor Tosteson ◽  
Yvon Bryan
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Patient Outcomes ◽  
Clinical Studies ◽  
Effect Modification ◽  
Medical Interventions ◽  
Patient Health ◽  
Independent Variable ◽  
The Relationship

Observational clinical research studies aim to assess which exposures (treatments or other factors; independent variable) affect patient outcomes (dependent variable). These exposures include medical interventions in situations where clinical trials are not possible or prior to their conduct and completion. However, the assessment of the relationship between exposures and outcomes is not straightforward, as other variables may need to be considered prior to reaching valid conclusions. Here, we present three hypothetical scenarios in regional anesthesia to review the epidemiological concepts of confounding, mediation, and effect modification. Understanding these concepts is critical for assessing the design, analysis, and interpretation of clinical studies. These terms may be confusing to anesthesiologists and researchers alike, where such confusion could affect the conclusions of a clinical study, mislead the target audience, and ultimately impact patient health.

Ransomware attacks in healthcare: vulnerabilities and technical countermeasures (Preprint)

2021 ◽  
Author(s):  
Hyeokchan Kwon ◽  
Byungho Chung
Keyword(s):  
Medical Devices ◽  
The United States ◽  
Point Of View ◽  
University Hospital ◽  
Security Technology ◽  
Intrusion Prevention ◽  
Medical Institutions ◽  
Intrusion Prevention System ◽  
The Cost ◽  
The University

UNSTRUCTURED Ransomware attacks, such as Conti, Ryuk, Petya, and Sodinokibi, that target medical institutions are increasing rapidly. In 2020, in the United States., ransomware attacks affected over 600 separate clinics, hospitals, and organizations, and more than 18 million patient records. The cost of these attacks is estimated to be almost $21 billion USD [1]. The first death related to ransomware attacks was reported by the University Hospital of Düsseldorf in Germany in 2020. The aim of this literature is to study vulnerabilities of cybersecurity in medical institutions, characteristics of ransomware aimed at medical institutions, and technical measures to prevent ransomware. From a security point of view, one of the most important targets of hackers against hospitals is medical devices. Many medical devices in hospitals are equipped with outdated software that is vulnerable to security and have many restrictions on security patches/updates. In addition, it is not easy to install even security functions such as antivirus due to the specificity of medical devices where availability is most important. As introduced in the Medjack report issued by TrapX Labs, in many cases, attackers target medical devices that are relatively insecure and then penetrate deep into more critical network infrastructure, such as EMR servers [2]. In this literature, we discuss various considerations to respond to ransomware while ensuring the availability of medical devices, and present AI-MDIPS (AI-based medical device intrusion prevention system) technology, a non-invasive and manageable security technology applicable to medical devices developed by the Korean government

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