Assessment of an electronic system for research ethics committees document management: An observational study.

Since 1 January 2020, the Central Research Ethics Committee of the Health Ministry implemented PRIISA.BA, an in-house developed electronic system for online submission of health research applications to the 63 public and private research ethics committees (RECs) of Buenos Aires City, Argentina. This study though to compare the times to first review and the time to approval among applications submitted prior to PRIISA.BA and thereafter, across public RECs. All public RECs of the city were invited to participate. Overall, 453 applications from 10 RECs (242 pre- and 211 post-PRIISA.BA) were available for the analyses. There was a decrease in the time to first review and an increase in the time to approval after PRIISA.BA implementation. The increase in time to approval was transient and limited to the first three months. The results were consistent with analyses limited to non-COVID applications. Our results show an increase in the times to approval after the implementation of an electronic system for online submission of health research applications that, although transient, was significant. These data could be relevant to other RECs implementing this technology since it emphasizes the need of monitoring potential unnecessary delays in reviews during the critical initial period.

The Effect of Shared Decisionmaking on Patients' Likelihood of Filing a Complaint or Lawsuit: A Simulation Study.

STUDY OBJECTIVE: Shared decisionmaking has been promoted as a method to increase the patient-centeredness of medical decisionmaking and decrease low-yield testing, but little is known about its medicolegal ramifications in the setting of an adverse outcome. We seek to determine whether the use of shared decisionmaking changes perceptions of fault and liability in the case of an adverse outcome. METHODS: This was a randomized controlled simulation experiment conducted by survey, using clinical vignettes featuring no shared decisionmaking, brief shared decisionmaking, or thorough shared decisionmaking. Participants were adult US citizens recruited through an online crowd-sourcing platform. Participants were randomized to vignettes portraying 1 of 3 levels of shared decisionmaking. All other information given was identical, including the final clinical decision and the adverse outcome. The primary outcome was reported likelihood of pursuing legal action. Secondary outcomes included perceptions of fault, quality of care, and trust in physician. RESULTS: We recruited 804 participants. Participants exposed to shared decisionmaking (brief and thorough) were 80% less likely to report a plan to contact a lawyer than those not exposed to shared decisionmaking (12% and 11% versus 41%; odds ratio 0.2; 95% confidence interval 0.12 to 0.31). Participants exposed to either level of shared decisionmaking reported higher trust, rated their physicians more highly, and were less likely to fault their physicians for the adverse outcome compared with those exposed to the no shared decisionmaking vignette. CONCLUSION: In the setting of an adverse outcome from a missed diagnosis, use of shared decisionmaking may affect patients' perceptions of fault and liability.

Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs.

This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF. The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs.

Aportaciones de la Armada española en la introducción de la anestesia en España. La ciencia médica en el último tercio del siglo xix / Contributions of the Spanish Navy to the introduction of anaesthesia in Spain. Medical science in the last third of the xix century

Las últimas décadas del siglo xix son años de resurgimiento y progreso en el ámbito de la Sanidad Naval, encontrándose a la vanguardia de las estructuras sanitarias europeas del momento. En esta época, los médicos de la armada desarrollaron unos documentos conocidos como «Memorias Clínicas», establecidas previamente como obligatorias en sus reglamentos y ordenanzas. Preciosos documentos de la ciencia médica y arte de curar que se encuentran depositados en el Archivo General de la Marina (Viso del Marqués, Ciudad Real). Si bien la información recogida en estas Memorias es muy variada, hemos centrado el interés en aquellas que versan sobre el descubrimiento y desarrollo de la anestesia. La implantación de la misma en España estuvo rodeada de una inmensa polémica, con defensores y detractores. La exclusividad de los documentos que aquí se presentan es testimonio original del saber médico-quirúrgico de la época y sitúan la Sanidad Naval española a la vanguardia de las estructuras sanitarias europeas del momento(AU)

The last decades of the xix century were years of resurgence and progress in the field of Naval Health, which was in the vanguard of European health structures at that time. In this era, the navy physicians produced some documents known as “Memorias Clínicas” (Clinical Reports), previously established as obligatory in their rules and regulations. Valuable documents on medical science and the art of healing are deposited in the Archivo General de la Marina (Viso del Marqués, Ciudad Real). Although the information recorded in these Reports varies considerably, we have centred our interest on those that focus on the discovery and development of anaesthesia. The introduction of these discoveries was surrounded by immense controversy, with its defenders and critics. The exclusiveness of the documents presented here is an original testimony to the medical-surgical knowledge of the era and places Naval Health in the vanguard of European health structures at that time(AU)

Practical aspects of the preparation and filing of patent applications.

This chapter is intended to give a brief introduction into the most important patent basics. More importantly, it provides some practical advice to scientists on various considerations when contemplating and preparing the filing of a patent application, irrespective of whether this is assisted by a patent professional or not.

Evolución de la ciencia archivística / Evolution of the Archive Science

Se estudia la evolución histórica de la ciencia archivística, sus principales conceptos; así como las etapas de su desarrollo. Se examinan los paradigmas transitados por esta ciencia, a saber: paradigma clásico y paradigma social(AU)

The historical evolution of the Archive Science, its main concepts and the stages of its development are studied. The paradigms through which this science has gone through, that is, classic paradigm and social paradigm, are examined(AU)

Evolución de la ciencia archivística / Evolution of the Archive Science

Se estudia la evolución histórica de la ciencia archivística, sus principales conceptos; así como las etapas de su desarrollo. Se examinan los paradigmas transitados por esta ciencia, a saber: paradigma clásico y paradigma social.

The historical evolution of the Archive Science, its main concepts and the stages of its development are studied. The paradigms through which this science has gone through, that is, classic paradigm and social paradigm, are examined.

[Relevance of the hemovigilance regional database for the shared medical file identity server]. / Intérêt de la base de données régionale d'hémovigilance pour le serveur d'identités de la plate-forme régionale de dossier médical partagé.

The French Health Products Safety Agency coordinates the national initiative of computerization of blood products traceability within regional blood banks and public and private hospitals. The Auvergne-Loire Regional French Blood Service, based in Saint-Etienne, together with a number of public hospitals set up a transfusion data network named EDITAL. After four years of progressive implementation and experimentation, a software enabling standardized data exchange has built up a regional nominative database, endorsed by the Traceability Computerization National Committee in 2004. This database now provides secured web access to a regional transfusion history enabling biologists and all hospital and family practitioners to take in charge the patient follow-up. By running independently from the softwares of its partners, EDITAL database provides reference for the regional identity server.

Archivo de Archivos: 2007 / The archivos archive, 2007

No disponible

No disponible

Tomás Navarro Tomás y los orígenes de a fonética experimental en la JAE / Tomás Navarro Tomás and the origins of experimental phonetics at the JAe

La introducción en España de la fonética experimental, una rama de la lingüística fronteriza con las ciencias, tuvo como uno de sus principales protagonistas a Tomás Navarro Tomás, que dirigió un Laboratorio de Fonética en el Centro de Estudios Históricos de la Junta para Ampliación de Estudios. En este artículo se reconstruye una parte esencial de la formación de Navarro Tomás en ese campo, utilizando para ello las cartas que envió a Ramón Menéndez Pidal mientras estuvo pensionado en el extranjero (Francia y Alemania) por la Junta en 1912-1913. Se trata de una correspondencia que, además, presenta una excelente visión de la comunidad fonética europea de la época (AU)

The introduction in Spain of experimental phonetics, a branch of linguistic close to science, had as one of its main protagonists Tomás Navarro Tomás, who was the director of a Laboratory of Phonetics at the Historical Studies Center of the Junta para Ampliación de Estudios. In this article, we study Navarro Tomás’s education in that field, making use of the letters he sent to Ramón Menéndez Pidal while he was abroad (France and Germany) supported by the Junta in 1912-1913. Besides, that correspondence presents an splendid view of the European phonetic community of the time (AU)

Managing your paperwork.

The possibilities for better handling of the career's necessary paperwork are endless. The important first step is a commitment to improve, one habit or aspect at a time. Change is not easy, but your time is worth it.

Patient information extraction in digitized radiography.

Digital imagery is gradually replacing the traditional radiograph with the development of digital radiography and film scanner. This report presents a new method to extract the patient information number (PIN) field automatically from the film-scanned image using image analysis technique. To evaluate the PIN field extraction algorithm, 2 formats of label acquired from 2 different hospitals are tested. Given the available films with no constraints on the way the labels are written and positioned, the correct extraction rates are 73% and 84%, respectively. This extracted PIN information can link with Radiology Information System (RIS) or Hospital Information System (HIS), and the image scanned from the film then can be filed into the database automatically. The efficiency this method offers can simplify greatly the image filing process and improve the user friendliness of the overall image digitization system. Moreover, compared with the bar code reader, it solves the automatic information input problem in a very economical way. The authors believe the success of this technique will benefit the development of the PACS (Picture Archiving and Communication System) and teleradiology.

A new approach to the film library: time-unit filing.

The installation of a new radiology information system (RIS) at Children's Hospital Medical Center of Akron in Akron, Ohio, took the radiology department into a new world of technology, but raised issues we never anticipated. The major problem the new RIS forced the department to overcome was how to eliminate the film file's reliance on a proprietary radiology numbering system. Previously, the department had used its own numbering system--a proprietary x-ray number--to file film jackets and had used the hospital-issued medical record number to access patient and payer information from the hospital information system. It became clear that we should use a single number--the medical record number--to access all data, but we wondered how that would affect our film file room. An RIS consultant suggested that we consider filing films by last date of service, a system called "time-unit filing." Time-unit filing means keeping the most recent two-weeks worth of films in the main file room. They are organized by gender in blue or pink jackets and marked alphabetically by the patient's last name in a way that makes mis-files easy to see. If a patient's film jacket is activated again, it is refiled in the current two-week time unit. Inactive jackets remain in their two-week time unit indefinitely. Time-unit filing has had many benefits for the radiology department at Children's Hospital Medical Center of Akron: fewer mis-files, less time needed for filing and searching, and successful implementation of the new RIS.