Towards a common framework for defining ancillary material quality across the development spectrum.

Ancillary materials (AMs) play a critical role in the manufacture of cell and gene therapies, and best practices for their quality management are the subject of ongoing discussion. Given that the final product cannot be sterilized, AM quality becomes increasingly critical to the clinical advancement of cell and gene therapies. Despite a lack of direct legislative direction regarding AM quality, internationally harmonized guidance is available from several industry-standard bodies that describe the principles and application of a risk-based approach to AM qualification and related supply-chain risk management. According to a best-practice risk-based approach, AMs must be adequately qualified to a degree that reflects the level of risk the material presents to patient safety and the drug product's specification. This general approach can be implemented in different ways, and balancing quality with cost of goods is critical to the cost-effective manufacture of advanced therapy medicinal products. In some cases, it may be preferable or necessary to use AMs that are produced in compliance with current Good Manufacturing Practice. However, developers may be able to suppress manufacturing costs without undermining safety or regulatory compliance in the case that a material presents a lower risk profile. Despite a great deal of attention and interest in the quality of AMs in the cell and gene therapy space, there is still a need for greater harmonization to create a shared understanding of what constitutes a risk-based approach to AM production and sourcing. In this article, we propose a staged approach to AM quality that achieves a balance between the competing demands of risk mitigation and cost of goods containment at the various stages of AM quality development. Our novel, heuristic framework for communication among AM suppliers, users and regulators aims to bring down development and manufacturing costs and lessen the workload around regulatory compliance.

Full blood count as an ancillary test to support the diagnosis of giant cell arteritis.

BACKGROUND: Temporal artery biopsy is considered the investigation of choice to diagnose definitively giant cell arteritis (GCA) in patients with compatible symptoms. However it is invasive and not completely sensitive. Serum markers, particularly erythrocyte sedimentation rate (ESR), can be supportive, but are not definitive in individual cases. AIMS: To investigate whether indices derived from the full blood count, including neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) were associated with a positive biopsy in patients with suspected GCA. METHODS: The clinical and pathological details of 537 patients undergoing temporal artery biopsy at our institution from 1992 to 2015 were reviewed. RESULTS: In univariate analysis high platelets (odds ratio (OR) 4.44, P < 0.001), NLR (OR 1.81, P = 0.02), PLR (OR 3.25, P < 0.001), C-reactive protein (CRP) (OR 3.00, P < 0.001), ESR (OR 3.62, P < 0.001) and increased age (OR 1.03, P = 0.006) were strongly associated with a positive biopsy. In multivariate modelling only high platelets (P < 0.001) and ESR (P = 0.049) maintained significance. CONCLUSIONS: We conclude that the presence of thrombocytosis and high NLR, PLR, ESR and CRP can all be used clinically to support the diagnosis of GCA prior to biopsy. Of particular note, in multivariate modelling the presence of thrombocytosis is a stronger predictor of a positive temporal artery biopsy than ESR. Therefore, careful consideration of the findings in a full blood count can be used to predict the likelihood of a positive temporal artery biopsy in patients with suspected GCA.

Simulación médica en punción aspiración con aguja fina utilizando maniquíes. Experiencia docente universitaria / Medical simulation training in fine needle aspiration cytology using phantoms. University teaching experience

Introducción. La punción aspiración con aguja fina (PAAF) es un procedimiento diagnóstico mínimamente invasivo y extremadamente útil para tipificar lesiones. La limitación de medios en las prácticas de anatomía patológica ha dificultado su enseñanza. Describimos la incorporación de maniquíes diseñados para realizar PAAF en nuestro centro. Material y métodos. Los maniquíes consisten en 2 simuladores de tareas, artesanales y a tamaño natural, de las regiones facial/cervical (modelo de utilidad U201500372) y de torso, respectivamente, revestidos por silicona, simulando piel, con áreas tumorales. Permiten realizar PAAF (palpación, punción, aspiración, obtención de material y extensión sobre portaobjetos) y son reutilizables. La práctica se realizó durante 3 cursos académicos (2013-2016) y consistió en realizar PAAF de manera individualizada sobre contexto clínico, con ulterior correlación citológica. Resultados. Un total de 178 estudiantes de medicina de la Universidad de Murcia de tercer curso realizaron la práctica (28 grupos: 105 mujeres, 73 hombres). La tasa de acierto (punción, aspiración de material y extensión en portaobjetos) fue del 97,2% con la primera punción. Además, 13 estudiantes procedentes de otras 10 universidades (nacionales e internacionales) llevaron a cabo la práctica, refiriendo la no existencia en sus centros de procedencia. Fue considerada como de gran valor sobre encuesta anónima. Discusión. Las prácticas de PAAF son fácilmente implementables y potencialmente incorporables a los formatos evaluativos tipo examen clínico objetivo estructurado (ECOE). No existe una adecuada estandarización en las prácticas de diferentes centros universitarios. Las prácticas de PAAF mejoran la formación del estudiante y proporciona un mayor conocimiento y una mejor consideración de nuestra especialidad (AU)

Background. Fine needle aspiration cytology (FNAC) is a minimally invasive and extremely useful procedure. The characteristics of the practice of pathology, together with limited equipment, make teaching this technique difficult. We therefore have introduced phantoms designed to perform FNAC as part of the medical education programme in our hospital. Material and methods. Phantoms are two life-sized hand-made reproductions of an adult head & neck (utility model ES1140059) and a trunk, respectively, coated with silicone simulating skin and with inserted tumor areas. They allow the whole FNAC process (palpation, puncture, aspiration, placement of material on slide and smear preparation) to be performed and, furthermore, are reusable. During 3 academic years (2013-2016) FNAC samples have been obtained in this way by each student individually, in a clinical context and with subsequent cytological correlation. Results. A total of 178 third year medical students from the University of Murcia, Spain, took part in the FNAC training programme (28 groups: 105 women, 73 men). The success rate in the first attempt (puncture, aspiration of material, placing and extending the obtained material on slides) was 97.2%. Furthermore, 13 students from 10 other universities (national and international) also took part, not having such a programme in their medical schools. In an anonymous survey the consensus was that it was valuable practical training. Discussion. Training in FNAC techniques is easy to include in the undergraduate curriculum and also in the Objective Structured Clinical Examination (OSCE) evaluation format. There is no proper standardization in training among different universities. FNAC simulation provides students with greater knowledge and appreciation of our specialty (AU)

Work schedules in health care in France: very few changes between 1991 and 1998, according to national data.

It is important to know whether working time schemes offer, following the adoption of the 1990 ILO Night Work Convention, a better use of the actual knowledge in moderating the adverse effects of shiftwork for both sexes. The last two national studies on a representative sample, about working conditions in France (1991, 1998), show an increase of night work among female nursing staff. Long hours of work are becoming more common for nurses. The percentage of women health care workers not working the same number of days every week increased, with work weeks of 7 days or more. Few positive aspects exist such as a reduction in the proportion of those having to work 17 Sundays or more and a reduction of shifts beginning before 7 a.m. for female nurses. New negotiations, starting in 2001, should be an opportunity for improvements.

Plan de reconversión hospitalaria: Hospital Vélez Sarfield

Información sobre distintos servicios del hospital: Médicos de cabecera, turnos telefónicos, extensión horaria, informatización de servicios, internación domiciliaria, y participación comunitaria

Plan de reconversión hospitalaria: Hospital Vélez Sarfield

Información sobre distintos servicios del hospital: Médicos de cabecera, turnos telefónicos, extensión horaria, informatización de servicios, internación domiciliaria, y participación comunitaria