Implementing near real-time vaccine safety surveillance using the Clinical Practice Research Datalink (CPRD).

INTRODUCTION: Near real-time vaccine safety surveillance (NRTVSS) using electronic health records is increasingly used to rapidly detect vaccine safety signals. NRTVSS has not been fully implemented in the UK. We assessed the feasibility of implementing this surveillance using the UK Clinical Practice Research Datalink (CPRD). METHODS: We selected seasonal influenza vaccine/Guillain-Barré Syndrome (GBS) as an example of a rare outcome and measles-mumps-rubella (MMR) vaccine/febrile seizures as a positive control. For influenza/GBS we implemented a system for the 2013/2014 and 2014/2015 influenza seasons; for MMR/seizures the surveillance period was July 2014-June 2015. We used the continuous Poisson-based maximized sequential probability ratio test (PMaxSPRT), comparing observed-to-expected events, for both pairs. We calculated an age-sex-adjusted rate using 5years of historic data and used this rate to calculate the expected number of events in pre-specified post-vaccination risk-window (GBS: 0-42days, seizures: 6-21days). For MMR/seizures we also implemented the system using the Binominal-based maximized sequential probability ratio test (BMaxSPRT). For this, we compared seizures in the risk-window (6-21days) to a control window (0-5 and 22-32days). Delays in recording outcomes influence the data available, so we adjusted the expected number of events using a historical distribution of delays in recording GBS/febrile seizures. Analyses were run using data up to each CPRD monthly release. We also performed power calculations for detecting increases in relative risk (RR) from 1.5 to 10. RESULTS: For influenza/GBS we implemented a system in both seasons with no signal. Power to detect a signal was >80% for RR≥4. For MMR/seizures we were able to identify a signal with PMaxSPRT but not with BMaxSPRT. Power≥80% for RR≥2.5 for both tests. CONCLUSION: CPRD is a potential data source to implement NRTVSS to exclude large increases in the risk of rare outcomes after seasonal influenza and lower increases in risk for more frequent outcomes.

La salud digital como motor de cambio hacia nuevos modelos asistenciales y de relación entre los pacientes y los profesionales de la salud. La disrupción de los procesos asistenciales / No disponible

Nos encontramos al final de una época de asimetría en el dominio de la información de salud, donde la mayor parte de esta se halla bajo custodia del sistema sanitario. Cada vez más, el ciudadano reclama un papel central dentro del nuevo paradigma, que le posibilite ejercer adecuadamente el derecho de acceso a sus datos de salud y disponer de tecnologías fiables y seguras que contribuyan al manejo de su condición y la promoción de estilos de vida saludables. Hasta ahora, el plan estratégico TIC Salud se desarrollaba de forma independiente al Plan de Salud del Departament de Salut de la Generalitat de Catalunya, que marca la estrategia de las políticas de salud en el territorio catalán. Sin embargo, el nuevo Plan de Salud (2016- 2020) contempla desde su diseño inicial la incorporación de una nueva línea estratégica TIC (tecnologías de la información y la comunicación) denominada “Salud Digital”. Introducir las TIC en el Plan de Salud va a permitir que estas tecnologías sean integradas en todos los procesos asistenciales estratégicos, actuando como motor de cambio hacia nuevos modelos asistenciales y de relación entre los ciudadanos y los profesionales de la salud. La Salud Digital lleva consigo disrupción, por la convergencia de distintas tecnologías y su impacto positivo sobre la salud y los procesos asistenciales, por el acceso de todos los ciudadanos a la información sobre su salud y por la generación de nuevas oportunidades para la promoción de la salud y el paradigma salutogénico, que empodera al ciudadano en el desarrollo de su salud, bienestar y calidad de vida (AU)

We find ourselves at the end of an era of asymmetry in the domain of health information where the majority of this data is in the hands of the healthcare system. Increasingly, the public are calling for a more central role in the new paradigm that enables them to duly exercise their right of access to their health data while availing of more reliable and safer technologies which contribute to the management of their condition and promote healthy lifestyles. So far, the TIC Salud strategic plan has been developed independently from the Generalitat de Catalunya Health Department's Healthcare Plan, which sets out health policy strategy in Catalonia. However, from its initial design stage the new Healthcare Plan (2016- 2020) envisages incorporating a new strategic Information and communications technology (ICT) line called “Digital Health”. Incorporating ICT into the Health Plan will allow these technologies to become integral part of all strategic healthcare processes, acting as a driving force for a shift towards a new healthcare models and an innovative relationship between the public and healthcare professionals. The Digital Health implies a disruption in itself, by way of the convergence of several technologies and their positive impact on health and healthcare procedures, by way of the public's access to information concerning their health, and by creating new opportunities for promoting health and the salutogenic paradigm which empowers people to develop their health, welfare and quality of life (AU)

Legal Considerations for Electronic Health Records.

Electronic health record (EHR) solutions provide many potential benefits for dental practices, whether those programs run internally on a dental practice's computers or are cloud-based solutions. However, these programs also create new risks for a dental practice, which may be mitigated through due diligence and adequate contractual provisions to ensure protection for dentists. This article addresses the legal considerations associated with a dentist entering into a service contract with an EHR vendor.

Maintaining proper dental records.

Referred to as Standard of Care, the legal duty of a dentist requires exercising the degree of skill and care that would be exhibited by other prudent dentists faced with the same patient-care situation. Primarily, the goal of keeping good dental records is to maintain continuity of care. Diligent and complete documentation and charting procedures are essential to fulfilling the Standard of Care. Secondly, because dental records are considered legal documents they help protect the interest of the dentist and/or the patient by establishing the details of the services rendered. Patients today are better educated and more assertive than ever before and dentists must be equipped to protect themselves against malpractice claims. Every record component must be handled as if it could be summoned to a court room and scrutinized by an attorney, judge or jury. Complete, accurate, objective and honest entries in a patient record are the only way to defend against any clinical and/or legal problems that might arise. Most medical and dental malpractice claims arise from an unfavorable interaction with the dentist and not from a poor treatment outcome. By implementing the suggestions mentioned in this course, dental health care professionals can minimize the legal risks associated with the delivery of dental care to promote greater understanding for patients of their rights and privileges to their complete record.

Efectos de variables tecnológicas y de la titulación universitaria en la creatividad ideacional / Effects of tecnological variables and the university degree in the creativity ideational

El objetivo del presente estudio fue examinar los efectos de tres variables -herramientas informáticas, objetos tecnológicos y titulación universitaria- en la generación de ideas creativas tanto a nivel individual como grupal. La investigación se llevó a cabo con una muestra de 112 alumnos de la Universidad Pública de Navarra (España) organizados en diferentes grupos experimentales y de control según las exigencias de las hipótesis planteadas. La intervención consistió en la ejecución de actividades que requerían a los sujetos la elaboración de ideas sobre los siguientes campos: soluciones a un problema, utilidades de algunos objetos y mejoras de otros objetos. Los resultados revelaron que los sujetos que trabajaron tanto con herramientas informáticas como con objetos tecnológicos y que pertenecían a la titulación de Ingeniería Técnica en Informática de Gestión, enunciaron mayor número de ideas en las distintas actividades de intervención que los sujetos que trabajaron sin herramientas informáticas, con objetos convencionales y que pertenecían a la titulación de Trabajo Social. Finalmente, se ofrecen en este estudio algunas conclusiones relevantes (AU)

The aim of the present study was to examine the effects of three variables -computer tools, technological objects and university degree- in the generation of creative ideas so much to individual level as group. The research was carried out by a sample of 112 pupils of the Public University of Navarre (Spain) organized in different experimental and control groups according to the requirements of the raised hypotheses. The intervention consisted of the execution of activities that required the subjects the development of ideas on the following fields: solutions to a problem, utilities of some objects and improvements of other objects. The results revealed that the subjects that worked both with computer tools and with technological objects and that belonged to the degree of Technical Engineering in Computer Science of Management, enunciated major number of ideas in the different activities of intervention that the subjects that worked without computer tools, with conventional objects and that belonged to the degree of Social Work. Finally, some relevant conclusions offer in this study (AU)

Copyright in the digital classroom.

Copyright law was developed to protect the rights of authors. Many educators are aware of copyright law, but they may not be aware of how it applies to them or of the law's scope in regards to computer technology. As the computer is used increasingly to disseminate information, teaching professionals also must have knowledge of the applications of the law to this developing technology. This article reviews the laws defining copyright and fair use. It examines case law regarding copyright, computers, and the Internet. Recommendations for using computers to disseminate class materials to students are discussed.

[Harmonization criteria for inspection procedures. Italian Group for Quality Assurance in Research]. / Criteri di armonizzazione delle modalità ispettive. GIQAR.

In order to achieve higher levels of harmonisation for the application of the principles of good laboratory practice (GLP), the monitoring Authority has set up for the inspectors some guidelines to conduct inspections, as approved by the National co-ordination committee. The extension of these guidelines should allow for an improved application of the GLP principles taking into account actual situations detected during inspections carried out over the past years. In this respect a great number of observations formulated by the inspectors after inspecting several test facilities have been examined without revealing laboratories' and inspectors' identities. In addition to this, the observations made by the inspectors during the annual training course at the Istituto Superiore di Sanità in 2000 have been carefully considered.

HIPAA is larger and more complex than Y2K.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a larger and more complex problem than Y2K ever was. According to the author, the costs associated with a project of such unending scope and in support of intrusion into both information and operational systems of every health care transaction will be incalculable. Some estimate that the administrative simplification policies implemented through HIPAA will save billions of dollars annually, but it remains to be seen whether the savings will outweigh implementation and ongoing expenses associated with systemwide application of the regulations. This article addresses the rules established for electronic data interchange, data set standards for diagnostic and procedure codes, unique identifiers, coordination of benefits, privacy of individual health care information, electronic signatures, and security requirements.