Aportaciones a un modelo de inserción de servicios asistenciales basados en telemedicina para su uso y validación en el seguimiento de pacientes crónicos

Hoy en día, se dispone de evidencia suficiente acerca de cuáles deben ser los componentes básicos de los nuevos modelos de provisión de cuidados a pacientes crónicos, si bien se desconoce cómo éstos deben ser combinados de forma efectiva, coherente, y transferible. Está plenamente asumido que el componente “tecnología de la información y la comunicación”, actúa como pilar básico en la cohesión y articulación de los modelos propuestos, y en este ámbito, bajo el paraguas de e-salud, están emergiendo las propuestas más sólidas. Las intervenciones en este campo constituyen un contexto interdisciplinario, multifactorial y complejo, que implica cambios sustanciales en la organización, la provisión de cuidados, la redistribución de recursos, la aparición de nuevos roles, etc., y en él, las metodologías de evaluación tradicionales se muestran poco eficaces para la obtención de evidencia significativa. Inspirados en metodologías aplicadas en ámbitos diversos (industrial, empresarial, desarrollo de software y sistemas, investigación en servicios de salud, etc.), se han propuesto estrategias híbridas que adoptan para la evaluación enfoques holísticos combinando además procedimientos tradicionales ampliamente aceptados, como la metodología de ensayo clínico aleatorizado. Sin embargo, se trata aún de propuestas de carácter general, poco específicas, y que además se enfrentan al reto de llevarse a cabo sobre unos sistemas sanitarios no preparados para ello, ya que parten de un planteamiento que requiere la implementación plena de la intervención en la organización sanitaria durante todo el proceso de evaluación. Es ampliamente reconocido que la complejidad implícita de la organización sanitaria es la principal dificultad para llevar a cabo las evaluaciones de los nuevos modelos de provisión de cuidados. Esta dificultad se manifiesta con mayor repercusión durante el proceso de implementación de la intervención. La implementación constituye un proceso condicionado por numerosos factores que implican cambios en los ámbitos del profesional sanitario, de la propia organización, incluso del propio sistema sanitario. Llevar a cabo una implementación temprana y plena de la intervención implica afrontar de golpe toda la complejidad del proceso, y puede ser origen de factores que comprometan la validez interna y externa de la evaluación, e incluso su propia viabilidad. El objetivo de esta tesis doctoral es definir una estrategia de evaluación que posibilite la obtención de evidencia temprana sobre la eficacia sanitaria de las intervenciones en un contexto de complejidad contenida, a partir de una implementación mínima en la organización, que sea complementada mediante recursos e infraestructuras externas a ésta. Para ello se ha tomado como punto de partida un modelo organizativo de cuidados a crónicos [Wagn96a][Wagn96b], y un modelo híbrido de evaluación de servicios asistenciales basados en e-salud [Mont04]. El trabajo realizado incluye: - la definición de una metodología de evaluación de servicios asistenciales basados en telemedicina dirigidos a pacientes crónicos, - su puesta en práctica a partir de un modelo de provisión, y una plataforma de servicios de telemedicina, y - su validación en dos escenarios diferentes Las contribuciones más destacables de esta tesis son: - la definición de una metodología de evaluación de servicios asistenciales basados en telemedicina para el escenario de las enfermedades crónicas. Desde la perspectiva de las intervenciones complejas, esta metodología aborda la evaluación como un proceso en fases consecutivas para la obtención progresiva de conocimiento y evidencia a diferentes niveles (tecnológico, sanitario, y de implementación), manteniendo un efecto de contención de la complejidad hasta las fases finales, - la especificación de un modelo de provisión que establece el contexto normalizado en el que se llevan a cabo las intervenciones, y que minimiza los efectos de la complejidad en las fases iniciales de la evaluación, - el diseño y desarrollo de una plataforma de servicios de telemedicina que implementa el modelo de provisión, y soporta el despliegue simultáneo de las intervenciones y de los estudios experimentales de evaluación. Dicha plataforma, cuya arquitectura que responde a un modelo mashup/SOA, está basada en normas y estándares internacionales, software de código abierto, y tecnologías Web basadas en Internet y redes celulares digitales, y - la validación de la viabilidad y funcionalidad del marco conceptual conjunto compuesto por la metodología de evaluación, el modelo de provisión, y la plataforma de servicios, en los escenarios de la hipertensión arterial y el tratamiento de anticoagulación oral. Summary Today there is sufficient available evidence concerning the basic components required for the new models of care provision for chronically ill patients, although how they should be combined to achieve effective, coherent and transferable results remains unknown. It is fully assumed that the “information and communication technology” component serves as the central pillar in the cohesion and articulation of the proposed models, and in this setting, under the e-health umbrella, more solid proposals are emerging. Interventions in this field constitute an interdisciplinary, multifactorial and complex context that involves substantial changes in organization, care provision, redistribution of resources, the development of new roles, etc., and within this context, the traditional methods of evaluation have been found to be little effective for obtaining significant evidence. Inspired by methodologies applied in different settings (industry, business, software and systems development, research in healthcare services, etc.), hybrid strategies have been proposed that adopt holistic approaches to evaluation, while combining widely accepted traditional procedures, such as the randomized clinical trial methodology. However, these proposals continue to be of a general, little specific nature and, in addition, face the challenge of being carried out in healthcare systems that are not prepared for this situation, since they are based on an approach that requires full implementation of the intervention in the healthcare organization throughout the entire process of evaluation. It is a widely recognized fact that the implicit complexity of healthcare organization is the major obstacle to carrying out the evaluations of the new care provision models. This difficulty has a greater impact during the process of implementing the intervention. The implementation constitutes a process conditioned by numerous factors that involve changes in the settings of the healthcare professional, in the organization itself, and even in the very healthcare system. The achievement of an early and full implementation of the intervention entails taking on the entire complexity of the process immediately and face to face, and can originate factors that compromise the internal and external validity of the evaluation, and even its very viability. The objective of this doctoral thesis is to define an evaluation strategy that makes it possible to obtain early evidence concerning the clinical efficacy of the interventions, in a context of contained complexity, based on a minimal implementation in the organization, which would be complemented by means of external resources and infrastructures. For this purpose, the chosen starting point was an organizational model of care for chronically ill patients [Wagn96a][Wagn96b], and a hybrid model for the evaluation of healthcare services based on e-health [Mont04]. The study performed includes: - the definition of a methodology for the evaluation of telemedicine-based healthcare services, focusing on chronically ill patients, - putting it into practice on the basis of a provision model and a platform for telemedicine services, and - its validation in two different settings. The major contributions of this thesis are: - the definition of a methodology for the evaluation of telemedicine-based healthcare services for the chronic disease setting. From the perspective of complex interventions, this methodology focuses on evaluation as a process in consecutive phases for the progressive gathering of knowledge and evidence at different levels (technological, clinical and implementation), maintaining an effect of contention of the complexity until the final phases, - the specification of a provision model that establishes the normalized context in which the interventions are carried out and minimizes the effects of the complexity in the initial phases of the evaluation, - the design and development of a telemedicine service platform that implements the provision model and supports the simultaneous deployment of the interventions and the experimental evaluation studies. This platform, whose architecture corresponds to a mashup/SOA model, is based on international norms and standards, open source software and Web technologies based on the Internet and digital cellular networks, and, - the validation of the viability and functionality of the joint conceptual framework encompassing the evaluation methodology, the provision model and the service platform, in the arterial hypertension and oral anticoagulation therapy settings

Service for the pseudonymization of electronic healthcare records based on ISO/EN 13606 for the secondary use of information

The availability of electronic health data favors scientific advance through the creation of repositories for secondary use. Data anonymization is a mandatory step to comply with current legislation. A service for the pseudonymization of electronic healthcare record (EHR) extracts aimed at facilitating the exchange of clinical information for secondary use in compliance with legislation on data protection is presented. According to ISO/TS 25237, pseudonymization is a particular type of anonymization. This tool performs the anonymizations by maintaining three quasi-identifiers (gender, date of birth and place of residence) with a degree of specification selected by the user. The developed system is based on the ISO/EN 13606 norm using its characteristics specifically favorable for anonymization. The service is made up of two independent modules: the demographic server and the pseudonymizing module. The demographic server supports the permanent storage of the demographic entities and the management of the identifiers. The pseudonymizing module anonymizes the ISO/EN 13606 extracts. The pseudonymizing process consists of four phases: the storage of the demographic information included in the extract, the substitution of the identifiers, the elimination of the demographic information of the extract and the elimination of key data in free-text fields. The described pseudonymizing system was used in three Telemedicine research projects with satisfactory results. A problem was detected with the type of data in a demographic data field and a proposal for modification was prepared for the group in charge of the drawing up and revision of the ISO/EN 13606 norm

How do women living with HIV experience menopause? Menopausal symptoms, anxiety and depression according to reproductive age in a multicenter cohort

Background: To estimate the prevalence and severity of menopausal symptoms and anxiety/depression and to assess the differences according to menopausal status among women living with HIV aged 45-60 years from the cohort of Spanish HIV/AIDS Research Network (CoRIS). Methods: Women were interviewed by phone between September 2017 and December 2018 to determine whether they had experienced menopausal symptoms and anxiety/depression. The Menopause Rating Scale was used to evaluate the prevalence and severity of symptoms related to menopause in three subscales: somatic, psychologic and urogenital; and the 4-item Patient Health Questionnaire was used for anxiety/depression. Logistic regression models were used to estimate odds ratios (ORs) of association between menopausal status, and other potential risk factors, the presence and severity of somatic, psychological and urogenital symptoms and of anxiety/depression. Results: Of 251 women included, 137 (54.6%) were post-, 70 (27.9%) peri- and 44 (17.5%) pre-menopausal, respectively. Median age of onset menopause was 48 years (IQR 45-50). The proportions of pre-, peri- and post-menopausal women who had experienced any menopausal symptoms were 45.5%, 60.0% and 66.4%, respectively. Both peri- and post-menopause were associated with a higher likelihood of having somatic symptoms (aOR 3.01; 95% CI 1.38-6.55 and 2.63; 1.44-4.81, respectively), while post-menopause increased the likelihood of having psychological (2.16; 1.13-4.14) and urogenital symptoms (2.54; 1.42-4.85). By other hand, post-menopausal women had a statistically significant five-fold increase in the likelihood of presenting severe urogenital symptoms than pre-menopausal women (4.90; 1.74-13.84). No significant differences by menopausal status were found for anxiety/depression. Joint/muscle problems, exhaustion and sleeping disorders were the most commonly reported symptoms among all women. Differences in the prevalences of vaginal dryness (p = 0.002), joint/muscle complaints (p = 0.032), and sweating/flush (p = 0.032) were found among the three groups. Conclusions: Women living with HIV experienced a wide variety of menopausal symptoms, some of them initiated before women had any menstrual irregularity. We found a higher likelihood of somatic symptoms in peri- and post-menopausal women, while a higher likelihood of psychological and urogenital symptoms was found in post-menopausal women. Most somatic symptoms were of low or moderate severity, probably due to the good clinical and immunological situation of these women.This work was supported by the Instituto de Salud Carlos III through the Red Temática de Investigación Cooperativa en Sida (RD06/006, RD12/0017/0018 and RD16/0002/0006) as part of the Plan Nacional I + D + I and cofinanced by ISCIII-Subdirección General de Evaluación and the Fondo Europeo de Desarrollo Regional (FEDER) and Accion Estrategica en Salud Intramural (PI15CIII/00027).S

How patients with COVID-19 managed the disease at home during the first wave in Spain: a cross-sectional study.

Most patients with mild COVID-19 had to stay at home trying to implement an optimal quarantine. The aim of this study was to describe the COVID-19 cases during the first wave of the pandemic in Spain, how they managed the disease at home, focusing on differences by age, as well as differences in knowledge, attitudes and preventive practices, compared with the uninfected population. An online survey was used to conduct a cross-sectional study of individuals who were 14 years or older living in Spain during the COVID-19 lockdown. The main variable was a COVID-19 case. Logistic regression models for COVID-19 cases were obtained using a backward stepwise procedure to assess the association between social variables, disease knowledge, attitudes, prevention practices and emotional impact. 3398 people completed the survey. Participants' mean age was 49.6 (SD=14.3). COVID-19 was significantly more prevalent among married people (5.3%) and those currently doing an on-site work (8.7%). Most of the COVID-19 cases stayed at home (84.0%) during the episode. There were significant age-based differences with regard to self-isolation conditions at home during the disease. COVID-19 cases showed better attitudes, practices and knowledge about disease symptoms and transmission than the uninfected population. COVID-19 cases also felt more depressed (adjusted OR: 3.46, 95% CI 1.45 to 8.26) and had better preventive behaviour than the uninfected population, such as always wearing a mask outside the home (adjusted OR 1.58, 95% CI 1.06 to 2.30). COVID-19 cases found it difficult to comply with recommended home self-isolation conditions, with differences by age group. COVID-19 had an important impact on care dependency in non-hospitalised patients, who were mostly dependent on their families for care. It is necessary to reinforce social and health services and to be ready to meet the care needs of populations during the different waves or in future epidemics.This work was supported by Instituto de Salud Carlos III through the National Tropical Diseases Research Network (RD16CIII/003/001RICET). The funders had no role in study design or in the collection, analysis and interpretation of data, or the decision to submit the article for publication.S

EXTRAE: EXTRaction of Associations between Diseases and Other Medical Concepts

El propósito de este proyecto es investigar en la mejora de las técnicas de extracción de Reglas de Asociación (RA) entre enfermedades, o entre enfermedades y otros conceptos médicos. Estas reglas permiten representar el conocimiento médico subyacente a un conjunto de Historias Clínica Electrónica (HCE). Concretamente nos planteamos explorar técnicas semisupervisadas que nos permitan alcanzar resultados equiparables a los de las técnicas supervisadas con una mínima supervisión. El proyecto se propone realizar avances significativos en la selección de reglas de asociación relevantes en el dominio de la salud, que pueden tener una alta aplicabilidad en la ayuda al diagnóstico y en la prevención de enfermedades.This project aims to improve the techniques for extracting Association Rules (AR) between diseases, or between diseases and other medical concepts. These rules allow the representation of medical knowledge underlying a set of Electronic Medical Records (EHR). Particularly, we plan to explore semi-supervised techniques that allow us to achieve similar results to those obtained using supervised techniques, but requiring minimal supervision. The project intends to make significant progress in the selection of relevant AR, which may be applied in the health domain for developing diagnostic help systems, or for disease prevention.Este trabajo ha sido parcialmente financiado por los proyectos EXTRAE (IMIENS 2017) y PROSA-MED (TIN2016-77820-C3-2-R)

Co-creation Initiatives in Healthcare in Small Communities

The uses of technology in public spaces are not new, but now we find new forms of social interactions and practices, socio-spatial representations and relationships. The close relationship between real and virtual worlds also opens up new ways of advancing knowledge. In order to facilitate the implementation of Open Science, we explore different co-creation methods with multiple stakeholders. All groups are involved and have influence throughout the project lifecycle: from the beginning, to planning, to implementation, to dissemination. Research activities should involve a wide variety of stakeholders interested, including government, educators, nurses, charities, civil societies, patient groups and the publics, based in a way to (1) obtaining contributions by customers, (2) selecting the best of these contributions, and (3) incorporating these selected contributions into products, processes, or services. Interactions between Information and Communication Technologies (ICT), public spaces, and healthcare are considered as s a tool for connecting people in small communities (enhancing participation). A Platform (DXP - Digital eXperience Platform) through “headless” technologies may provide content management capabilities and easy integration with devices and various sources, driven by user needs and developed with the concept of “Community in mind” in order to create strong and active communities and transform our small communities into more human environments, rather than just more high-tech places, and to understand that “smartness” should be people-friendly. It was applies the Responsible Research and Innovation (RRI) principles on the scientific process and governance, identify drivers and barriers, interests and values for current and future societal challenges.This research was financially supported by the European Union’s Horizon 2020 research and innovation programme under the grant agreement No 741527 (project ORION).S

Follow-up with Telemedicine in Early Discharge for COPD Exacerbations: Randomized Clinical Trial (TELEMEDCOPD-Trial)

The results reported by different studies on telemonitoring in patients with chronic obstructive pulmonary disease (COPD) have been contradictory, without showing clear benefits to date. The objective of this study was to ascertain whether an early discharge and home hospitalization telehealth program for patients with COPD exacerbation is as effective as and more efficient than a traditional early discharge and home hospitalization program. A prospective experimental non-inferiority study, randomized into two groups (telemedicine/control) was conducted. The telemedicine group underwent monitoring and was required to transmit data on vital constants and ECGs twice per day, with a subsequent telephone call and 2 home visits by healthcare staff (intermediate and at discharge). The control group received daily visits. The main variable was time until first exacerbation. The secondary variables were: number of exacerbations; use of healthcare resources; satisfaction; quality of life; anxiety-depression; and therapeutic adherence, measured at one and 6 months of hospital discharge. A total of 116 patients were randomized (58 to each group) without significant differences in baseline characteristics or time until first exacerbation, i.e. median 48 days (pp. 25-75:23-120) in the control group, and 47 days (pp. 25-75:19-102) in the intervention group; p = 0.52). A significant decrease in the number of visits was observed in the intervention versus the control group, 3.8 ± 1 vs 5.1 ± 2(p = 0.001), without significant differences in the number of exacerbations. In conclusion follow-up via a telemedicine program in early discharge after hospitalization is as effective as conventional home follow up, being the cost of either strategy not significantly different.This study was awarded a Health Research Fund (Fondo de Investigaciones Sanitarias/FIS) grant, dossier No. PI12/01161 of the Carlos III Institute of Health and the Ministry of Sciences, Innovation and Universities.S

A study protocol for development and validation of a clinical prediction model for frailty (ModulEn): a new European commitment to tackling frailty

There is a growing need to implement and evaluate the technological solutions that allow the early detection of age-related frailty and enable assessment of the predictive values of frailty components. The broad use of these solutions may ensure an efficient and sustainable response of health and social care systems to the challenges related to demographic aging. In this paper, we present the protocol of the ModulEn study that aims to develop and validate a predictive model for frailty. For this purpose, the sample composed by older adults aged 65-80 years and recruited from the community will be invited to use an electronic device ACM Kronowise® 2.0. This device allows proactive and continuous monitoring of circadian health, physical activity, and sleep and eating habits. It will be used during a period of seven to ten days. The participants will also be given the questionnaires evaluating the variables of interest, including frailty level, as well as their experience and satisfaction with the device use. Data provided from these two sources will be combined and the relevant associations will be identified. In our view, the implications of this study' findings for clinical practice include the possibility to develop and validate tools for timely prevention of frailty progress. In the long term, the ModulEn may contribute to the critical reduction of frailty burden in Europe