Standardising neonatal and paediatric antibiotic clinical trial design and conduct: the PENTA-ID network view.

Antimicrobial development for children remains challenging due to multiple barriers to conducting randomised clinical trials (CTs). There is currently considerable heterogeneity in the design and conduct of paediatric antibiotic studies, hampering comparison and meta-analytic approaches. The board of the European networks for paediatric research at the European Medicines Agency (EMA), in collaboration with the Paediatric European Network for Treatments of AIDS-Infectious Diseases network (www.penta-id.org), recently developed a Working Group on paediatric antibiotic CT design, involving academic, regulatory and industry representatives. The evidence base for any specific criteria for the design and conduct of efficacy and safety antibiotic trials for children is very limited and will evolve over time as further studies are conducted. The suggestions being put forward here are based on the adult EMA guidance, adapted for neonates and children. In particular, this document provides suggested guidance on the general principles of harmonisation between regulatory and strategic trials, including (1) standardised key inclusion/exclusion criteria and widely applicable outcome measures for specific clinical infectious syndromes (CIS) to be used in CTs on efficacy of antibiotic in children; (2) key components of safety that should be reported in paediatric antibiotic CTs; (3) standardised sample sizes for safety studies. Summarising views from a range of key stakeholders, specific criteria for the design and conduct of efficacy and safety antibiotic trials in specific CIS for children have been suggested. The recommended criteria are intended to be applicable to both regulatory and clinical investigator-led strategic trials and could be the basis for harmonisation in the design and conduct of CTs on antibiotics in children. The next step is further discussion internationally with investigators, paediatric CTs networks and regulators

Using geographical information systems for management of back-pain data

This is the post-print version of the Article. The official published version can be accessed from the link below - Copyright @ 2002 MCB UP LtdIn the medical world, statistical visualisation has largely been confined to the realm of relatively simple geographical applications. This remains the case, even though hospitals have been collecting spatial data relating to patients. In particular, hospitals have a wealth of back pain information, which includes pain drawings, usually detailing the spatial distribution and type of pain suffered by back-pain patients. Proposes several technological solutions, which permit data within back-pain datasets to be digitally linked to the pain drawings in order to provide methods of computer-based data management and analysis. In particular, proposes the use of geographical information systems (GIS), up till now a tool used mainly in the geographic and cartographic domains, to provide novel and powerful ways of visualising and managing back-pain data. A comparative evaluation of the proposed solutions shows that, although adding complexity and cost, the GIS-based solution is the one most appropriate for visualisation and analysis of back-pain datasets

Brucellosis Control in Malta and Serbia: A One Health Evaluation

Brucellosis, also known as \u201cundulant fever\u201d or \u201cMalta fever\u201d, is a zoonotic infection caused by microorganisms belonging to Brucella, a genus of gram-negative coccobacilli that behave as facultative intracellular pathogens of ruminants, swine and other animals. Brucellosis is a threat to public health, hence identifying the optimal way of preventing disease spread is important. Under certain circumstances, integrated, multidisciplinary \u201cOne Health\u201d (OH) initiatives provide added value compared to unidisciplinary or conventional health initiatives. Conceptualizing and conducting evaluations of OH approaches may help facilitate decisions on resource allocation. This article historically describes and compares Malta's 1995\u20131997 with Serbia's 2004\u20132006 brucellosis control programmes and quantitatively assesses the extent to which they were compliant with a OH approach. For both case studies, we describe the OH initiative and the system within which it operates. Characteristic OH operations (i.e., thinking, planning, working) and supporting infrastructures (to allow sharing, learning and systemic organization) were evaluated. We scored the different aspects of these programmes, with values ranging from zero to one (1 = strong integration of OH). Malta demonstrated a higher OH index (0.54) and ratio (1.37) than Serbia (0.49 and 1.14 respectively). We conclude that context and timing are key to determining how, when and why a One Health approach should be applied. The adoption of a true OH approach that involved systemic organization, leadership clarity and transdisciplinary communication, collaboration, and co-ordination was essential to Malta's successful eradication of brucellosis after several failed attempts. In contrast, contextual factors in Serbia permitted the successful adoption of a primarily sectorial approach for short term control of brucellosis. However, while a fully-fledged transdisciplinary OH approach was not initially required, it is likely to be key to maintenance of brucellosis control in the medium and long term. Through these two case studies, we demonstrate that One Health initiatives should be applied at the right place, at the right time, with the right people and using the appropriate conditions/infrastructure. Lastly, OH evaluations should include economic assessments to identify optimal of resources in these situations, thereby justifying funding and political support required

ACTIVITIES OF NURSE PRACTITIONERS AS IDENTIFIED BY MEDICAL DIRECTORS OF UNIVERSITY STUDENT HEALTH SERVICES

University health services play a very important role in the general health, performance, and well-being of the students, the university itself, and the community. As stated by the American College Health Association, the goal of a university health service is to promote and maintain those conditions which will permit and encourage each individual to realize optimum physical, emotional, intellectual, and social well-being. University students have special health care needs such as drug and alcohol abuses, emotional problems, and gynecological, sexual, and contraceptive problems. It is the goal of the health professionals involved with students to meet those needs. Because of these special health care needs, the increasing number of university students, and the present problems associated with medical care and medical distribution, nurse practitioners have become involved in some university percent of these nurse practitioners are in college health services.3 It was believed by the investigators of this study that nurse practitioners could play a special role in this area of health care. As student health medical directors are key persons in defining nurse practitioner activities, the purpose of this study was to determine the activities the directors identified as appropriate for nurse practitioners to perform in a university health care setting. The type of activities identified by them may be crucial in the decision to utilize nurse practitioners in the university student health setting

PadChest: A large chest x-ray image dataset with multi-label annotated reports

We present a labeled large-scale, high resolution chest x-ray dataset for the automated exploration of medical images along with their associated reports. This dataset includes more than 160,000 images obtained from 67,000 patients that were interpreted and reported by radiologists at Hospital San Juan Hospital (Spain) from 2009 to 2017, covering six different position views and additional information on image acquisition and patient demography. The reports were labeled with 174 different radiographic findings, 19 differential diagnoses and 104 anatomic locations organized as a hierarchical taxonomy and mapped onto standard Unified Medical Language System (UMLS) terminology. Of these reports, 27% were manually annotated by trained physicians and the remaining set was labeled using a supervised method based on a recurrent neural network with attention mechanisms. The labels generated were then validated in an independent test set achieving a 0.93 Micro-F1 score. To the best of our knowledge, this is one of the largest public chest x-ray database suitable for training supervised models concerning radiographs, and the first to contain radiographic reports in Spanish. The PadChest dataset can be downloaded from http://bimcv.cipf.es/bimcv-projects/padchest/