Informe de resposta ràpida sobre l’ús de l’espirometria telemàtica autoadministrada en el seguiment de pacients amb fibrosi quística

Espirometria; Fibrosi quística; TelemedicinaEspirometría; Fibrosis quística; TelemedicinaSpirometry; Cystic fibrosis; TelemedicineL'objectiu d'aquest informe és analitzar les recomanacions sobre l’ús de l’espirometria telemàtica autoadministrada en el seguiment de pacients amb FQ d’acord amb les guies de pràctica clínica, documents de consens publicats i posicionaments de les societats científiques, posant èmfasi en aquelles que facin referència al context de la pandèmia per COVID-1

Analyse van klachten na sterilisatie met Essure® in Nederland : Gezondheidsproblemen na een niet chirurgische sterilisatie-ingreep bij vrouwen

alleen digitaal verschenenHet RIVM heeft klachten geanalyseerd van vrouwen die zijn gesteriliseerd met Essure®. Dit zijn metalen veertjes die via de baarmoeder in beide eileiders worden gebracht waardoor deze na ongeveer 3 maanden dichtgroeien. Het voordeel van deze sterilisatiemethode is, in vergelijking met de traditionele afsluiting van de eileiders, dat er geen chirurgische ingreep voor nodig is. Het aantal gemelde klachten komt van ruim 1,5 procent van de circa 30.000 vrouwen die in Nederland met Essure® zijn behandeld. De meest genoemde klachten zijn pijn en vermoeidheid. Bij de pijnklachten gaat het vooral om de buik, de rug en het hoofd. Daarnaast worden hevige bloedingen tijdens en tussen de menstruatie, stemmingswisselingen, geheugenverlies en concentratieproblemen gemeld. Het werkelijke aantal vrouwen met klachten is onbekend. Veel vrouwen geven aan dat deze klachten hun dagelijks leven negatief beïnvloeden. Ze voelen de veertjes zitten of ervaren beperkingen bij het bewegen. Verder kunnen ze de dagelijkse taken en de zorg voor kinderen vaak minder goed uitvoeren. Er zijn ook vrouwen die aangeven dat hun relatie lijdt onder de ontstane problemen. Bij 16 procent van de vrouwen die klachten gemeld hebben, is Essure® verwijderd naar aanleiding van de klachten. 38 procent van de vrouwen in dit onderzoek heeft een afspraak gemaakt om dat te laten doen. De klachten zijn gemeld nadat hieraan via diverse kanalen aandacht is besteed. De Nederlandse Vereniging voor Obstetrie en Gynaecologie (NVOG) heeft de resultaten van de analyse medisch geduid. Sommige klachten zijn mogelijk toe te wijzen aan de plaatsing van Essure®, zoals bepaalde pijnklachten. Bij andere klachten is het moeilijker om een direct verband te leggen omdat er ook andere zaken van invloed kunnen zijn, zoals stoppen met de pil waardoor menstruatieklachten kunnen verergeren. Daarnaast komen verschillende klachten, bijvoorbeeld gewichtsschommelingen en urinewegproblemen, ook met enige regelmaat voor bij vrouwen die geen Essure® hebben. De gemelde klachten komen van vrouwen die tussen 2001 en 2016 het implantaat hebben gekregen. Hun gemiddelde leeftijd was 37 jaar op het moment van de sterilisatie.The RIVM has analyzed the complaints reported by women sterilized using Essure®. Essure® is a sterilization method where two metal coils are placed into both fallopian tubes through the cervix and uterus, provoking those to become blocked after approximately 3 months. In comparison with the traditional sterilization methods, the advantage of the Essure® method is that no surgical procedure is required. The complaints that were received came from more than1,5 percent of the 30.000 women who are estimated to have been sterilized using Essure® in the Netherlands. Probably not all women with health problems have submitted a complaint; therefore, the actual number of women with health problems is unknown. The most frequently mentioned health problems are pain and tiredness. The pain is reported to be located mainly in the abdomen, back, and head. In addition, heavy bleeding during and between menstruations, mood swings, memory loss and concentration problems are also reported frequently. Many women indicated that these health problems negatively affect their daily life. They feel the coils in their body and often experience limitations when moving. They are often less able to adequately perform their daily tasks and take care of their children.There are also women that indicated that their relationship was negatively affected by the health problems. In 16 percent of the women in this study, Essure® has been removed because of the health problems and 38 percent of the women have made an appointment to have Essure® removed. The complaints were submitted, among other reasons, because the media attention on problems experienced by women following sterilization using Essure®. The Dutch Society of Obstetrics and Gyneacology (NVOG) contributed to the interpretation of the results from this study. Some health problems can be directly related to Essure®, for instance some kinds of pain. For other health problems it is more difficult to establish a direct link, because other factors may influence the health problems as well. For instance, heavier menstruation may also be explained by the fact that women stopped taking oral contraceptives following sterilization using Essure®.Furthermore, there are other health problems such as weight changes and urinary tract problems that are also regularly experienced by women not sterilized with Essure®. Women that submitted a complaint were sterilized using Essure between 2001 and 2016. Their mean age at implantation was 37 years.Dutch Health Care Inspectorat

Methodological Frameworks and Dimensions to Be Taken Into Consideration in Digital Health Technology Assessment: protocol for a Scoping Review

Salut digital; eSalut; Intel·ligència artificial; Avaluació de tecnologies sanitàriesSalud digital; eSalud; Inteligencia artificial; Evaluación de tecnologias sanitariasDigital health; eHealth; Artificial intelligence; Health technology assessmentBackground: Health technology assessment (HTA) is one of the main tools that health systems have to appraise evidence and determine the value of a given health technology. Although the existing HTA frameworks are useful tools for the evaluation of a wide range of health technologies, more and more experts, organizations across the world, and HTA agencies are highlighting the need to update or develop specific methodological frameworks for the evaluation of digital health technologies in order to take into account additional domains that cover these technologies’ intrinsic characteristics. Objective: The purpose of our scoping review is to identify the methodological frameworks that are used worldwide for the assessment of digital health technologies; determine what dimensions and aspects are being considered; and generate, through a thematic analysis, a proposal for a methodological framework that is based on the most frequently described dimensions in the literature. Methods: The scoping review will be performed in accordance with the guidelines established in the updated statement of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). We will search for peer-reviewed and grey literature published between 2011 and the date of the search execution. The retrieved references will be reviewed in a single-blind manner by 2 independent authors, and their quality will be assessed by using the Critical Appraisal Skills Program tool. The ATLAS.ti software (Scientific Software Development GmbH) will be used for data extraction and to perform the thematic analysis. Results: The scoping review is currently (May 2022) in progress. It is expected to be completed in October 2022, and the final results of the research will be presented and published by November 2022. Conclusions: To our knowledge, no studies have been published to date that identify the existing methodological frameworks for digital HTA, determine which dimensions must be evaluated for correct decision-making, and serve as a basis for the development of a methodological framework of reference that health care systems can use to carry out this kind of assessment. This work is intended to address this knowledge gap of key relevance for the field of HTA.This research is framed within the budget of the work plan of the Spanish Network of Health Technology Assessment Agencies and Benefits of the National Health System

Genetic Variation in FADS Genes and Plasma Cholesterol Levels in 2-Year-Old Infants

Single nucleotide polymorphisms (SNPs) in genes involved in fatty acid metabolism (FADS1 FADS2 gene cluster) are associated with plasma lipid levels. We aimed to investigate whether these associations are already present early in life and compare the relative contribution of FADS SNPs vs traditional (non-genetic) factors as determinants of plasma lipid levels. Information on infants' plasma total cholesterol levels, genotypes of five FADS SNPs (rs174545, rs174546, rs174556, rs174561, and rs3834458), anthropometric data, maternal characteristics, and breastfeeding history was available for 521 2-year-old children from the KOALA Birth Cohort Study. For 295 of these 521 children, plasma HDLc and non-HDLc levels were also known. Multivariable linear regression analysis was used to study the associations of genetic and non-genetic determinants with cholesterol levels. All FADS SNPs were significantly associated with total cholesterol levels. Heterozygous and homozygous for the minor allele children had about 4% and 8% lower total cholesterol levels than major allele homozygotes. In addition, homozygous for the minor allele children had about 7% lower HDLc levels. This difference reached significance for the SNPs rs174546 and rs3834458. The associations went in the same direction for non-HDLc, but statistical significance was not reached. The percentage of total variance of total cholesterol levels explained by FADS SNPs was relatively low (lower than 3%) but of the same order as that explained by gender and the non-genetic determinants together. FADS SNPs are associated with plasma total cholesterol and HDLc levels in preschool children. This brings a new piece of evidence to explain how blood lipid levels may track from childhood to adulthood. Moreover, the finding that these SNPs explain a similar amount of variance in total cholesterol levels as the non-genetic determinants studied reveals the potential importance of investigating the effects of genetic variations in early life

Evaluación de la seguridad, la validez diagnóstica y la efectividad clínica de la medición transcutánea de la presión parcial de oxígeno en el manejo del pie diabético

Medición transcutánea; Presión parcial de oxígeno; Pie diabéticoTranscutaneous measurement; Partial pressure of oxygen; Diabetic footMesurament transcutani; Pressió parcial d'oxigen; Peu diabèticEl objetivo general del presente informe es evaluar el uso de la medición de TcPO2 en el manejo del pie diabético y comparar su seguridad, validez diagnóstica, utilidad pronóstica en la evolución del pie diabético, y utilidad predictiva en el tratamiento vascular del pie diabético respecto a otras pruebas utilizadas en la evaluación del estado vascular del paciente, principalmente el ITB.L’objectiu general d’aquest informe és avaluar l’ús de la mesura de TcPO2 en el tractament del peu diabètic i comparar la seva seguretat, validesa diagnòstica, utilitat pronòstica en l’evolució del peu diabètic i utilitat predictiva en el tractament vascular del peu diabètic en comparació amb altres proves utilitzades per avaluar l’estat vascular del pacient, principalment l’ITB.The overall aim of this report is to evaluate the use of TcPO2 measurement in diabetic foot management and to compare its safety, diagnostic validity, prognostic utility in diabetic foot outcomes, and predictive utility in diabetic foot vascular management with other tests used to assess the patient’s vascular status, primarily ABI

SAR interferometry at Venus for topography and change detection

AbstractSince the Magellan radar mapping of Venus in the early 1990’s, techniques of synthetic aperture radar interferometry (InSAR) have become the standard approach to mapping topography and topographic change on Earth. Here we investigate a hypothetical radar mission to Venus that exploits these new methods. We focus on a single spacecraft repeat-pass InSAR mission and investigate the radar and mission parameters that would provide both high spatial resolution topography as well as the ability to detect subtle variations in the surface. Our preferred scenario is a longer-wavelength radar (S or L-band) placed in a near-circular orbit at 600km altitude. Using longer wavelengths minimizes the required radar bandwidth and thus the amount of data that will be transmitted back to earth; it relaxes orbital control and knowledge requirements. During the first mapping cycle a global topography map would be assembled from interferograms taken from adjacent orbits. This approach is viable due to the slow rotation rate of Venus, causing the interferometric baseline between adjacent orbits to vary from only 11km at the equator to zero at the inclination latitude. To overcome baseline decorrelation at lower latitudes, the center frequency of a repeated pass will be adjusted relative to the center frequency of its reference pass. During subsequent mapping cycles, small baseline SAR acquisitions will be used to search for surface decorrelation due to lava flows. While InSAR methods are used routinely on Earth, their application to Venus could be complicated by phase distortions caused by the thick Venus atmosphere

Marc metodològic per a l’avaluació de tecnologies de salut digital

Tecnologies de salut digital; Avaluació; Sistema Nacional de SalutDigital health technologies; Evaluation; National Health SystemTecnologías de salud digital; Evaluación; Sistema Nacional de SaludEl Ple del Consell de la Xarxa Espanyola d’Agències d’Avaluació de Tecnologies Sanitàries i Prestacions del Sistema Nacional de Salut (RedETS, per la seva denominació en castellà) va encarregar a l’Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS) desenvolupar, amb la col·laboració de les altres agències que conformen la RedETS, un marc d’avaluació adaptat a les TSD que detallés els dominis i dimensions a avaluar, així com els estàndards d’evidència a considerar, per determinar el valor de les TSD. En aquest article es descriu la metodologia utilitzada pel seu desenvolupament, així com les característiques principals que el defineixen

Técnicas endoscópicas bariátricas primarias en personas adultas con o sin diabetes mellitus tipo 2

Tècniques endoscòpiques bariàtriques; Adults; Diabetis mellitus tipus 2Técnicas endoscópicas bariátricas; Adultos; Diabetes mellitus tipo 2Bariatric endoscopic techniques; Adults; Diabetes mellitus type 2L'objectiu d’aquest informe és identificar i avaluar l’evidència disponible sobre l’eficàcia, efectivitat i seguretat de les tècniques endoscòpiques en el tractament primari de persones adultes amb obesitat, amb DM tipus 2 o sense, i formular recomanacions sobre la seva inclusió o no a la Cartera Comú de Serveis del Sistema Nacional de Salut espanyol.El objetivo de este informe es identificar y evaluar la evidencia disponible sobre la eficacia, efectividad y seguridad de las técnicas endoscópicas en el tratamiento primario de personas adultas con obesidad con o sin DM tipo 2 y formular recomendaciones sobre su inclusión o no en la cartera de servicios comunes del Sistema Nacional de Salud español.The aim of this report is to identify and evaluate all available evidence on efficacy, effectiveness and security of endoscopic techniques in primary treatment of adults with obesity with or without type 2 DM and to draw up recommendations on including them or not in the Health Portfolio of the Spanish National Health System

Health technology assessment framework: adaptation for digital health technology assessment

Tecnologia de salut digital; Avaluació de tecnologia sanitària; MetodologiaTecnología de salud digital; Evaluación de tecnología sanitaria; MetodologíaDigital health technology; Health technology assessment; MethodologyEl objetivo principal de este encargo es desarrollar un marco metodológico específico para la ETS de salud digital (ETSd) y se concreta en los siguientes objetivos específicos: determinar qué dominios, dimensiones y subdimensiones debe considerar la ETSd, con especial atención a los modelos de atención no presencial (MANP), la sald móvil (mSalud) y la inteligencia artificial (IA); definir un marco de estándares de evidencia que deben alcanzar estas tecnologías según la clasificación del riesgo que deriva de su uso.L’objectiu principal d’aquest encàrrec és desenvolupar un marc metodològic específic per a l’ATSd i es concreta en els següents objectius específics: determinar quins dominis, dimensions i subdimensions ha de considerar l’ATSd, amb especial atenció als models d’atenció no presencial (MANP), la salut mòbil (mSalut) i la intel·ligència artificial (IA); definir un marc d’estàndards d’evidència que han d’assolir aquestes tecnologies segons la classificació del risc que deriva del seu ús.The main objective of this assignment is to develop a specific methodological framework for the evaluation of digital health technologies (DHTs), and is specified in the following specific objectives: to determine which domains, dimensions, and sub-dimensions should be considered in DHT evaluation, with special attention to non-face-to-face care models (NFTC), mobile health (mHealth), and artificial intelligence (AI); to define a framework of evidence standards that these technologies must achieve according to the risk classification derived from their use

Telemonitorización de la función pulmonar a través de la espirometría autoadministrada en pacientes con asma, enfermedad pulmonar obstructiva crónica o fibrosis quística: evaluación de la seguridad, la eficacia clínica y aspectos de implementación

Malaltia pulmonar obstructiva crònica; Asma; EspirometriaEnfermedad pulmonar obstructiva crónica; Asma; EspirometríaChronic obstructive pulmonary disease; Asthma; SpirometryAquest informe es va plantejar amb la finalitat d’obtenir informació rellevant per determinar si l’espirometria telemàtica autoadministrada per part dels pacients amb asma, MPOC o FQ s’hauria d’oferir dins de la cartera de serveis comuns del Sistema Nacional de Salut (SNS). L’objectiu general de l’informe va ser avaluar la seguretat, l’eficàcia i els aspectes econòmics, organitzatius, socials, legals i ètics de la implementació de l’espirometria telemàtica autoadministrada per part dels pacients per al seguiment de les MRC en comparació de l’espirometria convencional feta per personal d’infermeria o tècnics especialitzats en una consulta de pneumologia hospitalària o al centre d’atenció primària, segons el protocol de seguiment del centre en qüestió, centrant-se en pacients de qualsevol edat amb asma o FQ i en adults amb MPOC.El presente informe se planteó con la finalidad de obtener información relevante para determinar si la espirometría telemática autoadministrada por parte de los pacientes con asma, EPOC o FQ, debería ofrecerse dentro de la cartera de servicios comunes del Sistema Nacional de Salud (SNS). El objetivo general del informe fue evaluar la seguridad, la eficacia y los aspectos económicos, organizativos, sociales, legales y éticos de la implementación de la espirometría telemática autoadministrada por parte de los pacientes para el seguimiento de las ERC en comparación con la espirometría convencional realizada por personal de enfermería o técnicos especializados en una consulta de neumología hospitalaria o en el centro de atención primaria, según el protocolo de seguimiento del centro en cuestión, centrándose en pacientes de cualquier edad con asma o FQ y adultos con EPOC.The present report was carried out to obtain relevant information with a view to determining whether asthma, COPD or CF patient self-performed telematic spirometry should be offered among the common services of the Spanish National Health System (Sistema Nacional de Salud [SNS]). The general objective of the report was to assess the safety, efficacy and economic, organizational, social, legal and ethical aspects of the adoption of patient self-performed telematic spirometry for the monitoring of CRDs versus conventional spirometry performed by nursing staff or specialized technicians in the hospital pneumology or primary care setting, based on the monitoring protocol of the centre involved, and focused on patients of any age with asthma or CF, and on adults with COPD