Five years of Hospital at Home adoption in Catalonia: impact, challenges, and proposals for quality assurance.

BACKGROUND: Hospital at home (HaH) was increasingly implemented in Catalonia (7.7 M citizens, Spain) achieving regional adoption within the 2011-2015 Health Plan. This study aimed to assess population-wide HaH outcomes over five years (2015-2019) in a consolidated regional program and provide context-independent recommendations for continuous quality improvement of the service. METHODS: A mixed-methods approach was adopted, combining population-based retrospective analyses of registry information with qualitative research. HaH (admission avoidance modality) was compared with a conventional hospitalization group using propensity score matching techniques. We evaluated the 12-month period before the admission, the hospitalization, and use of healthcare resources at 30 days after discharge. A panel of experts discussed the results and provided recommendations for monitoring HaH services. RESULTS: The adoption of HaH steadily increased from 5,185 episodes/year in 2015 to 8,086 episodes/year in 2019 (total episodes 31,901; mean age 73 (SD 17) years; 79% high-risk patients. Mortality rates were similar between HaH and conventional hospitalization within the episode [76 (0.31%) vs. 112 (0.45%)] and at 30-days after discharge [973(3.94%) vs. 1112(3.24%)]. Likewise, the rates of hospital re-admissions at 30 days after discharge were also similar between groups: 2,00 (8.08%) vs. 1,63 (6.58%)] or ER visits [4,11 (16.62%) vs. 3,97 (16.03%). The 27 hospitals assessed showed high variability in patients' age, multimorbidity, severity of episodes, recurrences, and length of stay of HaH episodes. Recommendations aiming at enhancing service delivery were produced. CONCLUSIONS: Besides confirming safety and value generation of HaH for selected patients, we found that this service is delivered in a case-mix of different scenarios, encouraging hospital-profiled monitoring of the service.

Consensus on post COVID in the Spanish national health system: Results of the CIBERPOSTCOVID eDelphi study.

BACKGROUND: In 2021, the Spanish Ministry of Health launched the CIBERPOSTCOVID project to establish what post COVID was. The present study reports the level of agreement among stakeholders on post COVID and its clinical and diagnostic characteristics in the Spanish health system. METHODS: The agreement on post COVID among clinicians, public health managers, researchers and patients' representatives was explored in a real-time, asynchronous online Delphi. In a two-wave consensus, respondents rated from 1 (total disagreement) to 6 (total agreement) 67 statements related to terminology, duration, etiology, symptoms, impact on quality of life, severity, elements to facilitate diagnosis, applicability in the pediatric population, and risk factors. Consensus was reached when 70 % of ratings for a statement were 5 or 6, with an interquartile range equal or less than 1. FINDINGS: A total of 333 professionals and patients participated in this eDelphi study. There was agreement that post COVID was "a set of multi-organic symptoms that persist or fluctuate after acute COVID-19 infection and are not attributable to other causes" with a minimum duration of 3 months. The highest levels of agreement were found in the most frequent symptoms and its impacts on everyday activities. Aspects related to the diagnostic process and the measurement of its severity reached a lower level of consensus. There was agreement on the need to rule out previous health problems and assess severity using validated functional scales. However, no agreement was reached on the risk factors or specific features in the pediatric population. INTERPRETATION: This policy-based consensus study has allowed the characterization of post COVID generating collective intelligence and has contributed to an operational definition applicable in clinical practice, health services management and useful for research purposes in Spain and abroad. Agreements are consistent with existing evidence and reference institutions at European and international level.

Cluster Analysis of Home Mechanical Ventilation in COPD Patients: A Picture of the Real World and Its Impact on Mortality.

BACKGROUND: Treatment of chronic hypercapnic failure in COPD patients with home noninvasive ventilation (HNIV) remains unclear. AIM: To create a curated cohort of all COPD patients on HNIV in Catalonia, perform a cluster analysis, and evaluate mortality evolution. STUDY DESIGN AND METHODS: This study was a multicenter, observational study including all COPD patients on HNIV on 1st January of 2018. Patients were selected through the Catalan Health Service, and administrative and clinical data were obtained in the previous four years. Principal component analysis of mixed data and hierarchical clustering were performed to identify clusters of patients. Mortality was evaluated from 1 January 2018 until 31 December 2020. RESULTS: A total of 247 patients were enrolled. They were mostly male (78.1%), with a median (SD) age of 70.4 (9.4) years old. In 60%, 55% and 29% of patients, obesity, sleep apnea and heart failure coexisted, respectively. Cluster analysis identified four well-differentiated groups labeled for their clinical characteristics: (1) obese smokers, (2) very severe COPD, (3) sleep apnea and (4) older comorbid males. Patients belonging to Clusters (2) and (4) had a worse prognosis than patients in Clusters (1) and (3). INTERPRETATION: A high heterogeneity in the prescription of HNIV was demonstrated. Cluster analysis identifies four different groups, of which only one had COPD as the main cause of ventilation, while the other three clusters showed a predominance of other comorbidities. This leads to different survival outcomes, including an overlapping phenotype of obesity-related disease and sleep apnea with better survival.

Coste-efectividad del desfibrilador automático implantable para la prevención primaria de la muerte súbita cardiaca / Cost-effectiveness of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death

Introducción y objetivos: El desfibrilador automático implantable (DAI) es una alternativa coste-efectiva para la prevención secundaria de la muerte súbita cardiaca, pero sigue habiendo dudas sobre su eficiencia en prevención primaria, sobre todo en pacientes con cardiopatía no isquémica.Métodos: Análisis de coste-utilidad del DAI más tratamiento médico convencional frente a tratamiento médico convencional para la prevención primaria de arritmias cardiacas desde la perspectiva del Sistema Nacional de Salud. Se simuló el curso de la enfermedad mediante modelos de Markov en pacientes con y sin cardiopatía isquémica. Los parámetros del modelo se basaron en los resultados obtenidos mediante metanálisis de los ensayos clínicos publicados entre 1996 y 2018 en los que se comparaba el DAI con el tratamiento médico convencional, los resultados de seguridad del ensayo DANISH y el análisis de la práctica clínica habitual en un hospital terciario.Resultados: Se estimó un beneficio del DAI sobre la muerte por cualquier causa con HR = 0,70 (IC95%, 0,58-0,85) en cardiopatía isquémica y HR = 0,79 (IC95%, 0,66-0,96) en no isquémica. La razón de coste-efectividad incremental estimada mediante análisis probabilístico fue de 19.171 euros/año de vida ajustado por calidad (AVAC) en pacientes con cardiopatía isquémica, 31.084 euros/AVAC en pacientes con miocardiopatía dilatada no isquémica y 23.230 euros/AVAC en los menores de 68 años.Conclusiones: La eficiencia del DAI monocameral ha mejorado en la última década y este resulta coste-efectivo para los pacientes con disfunción ventricular izquierda de origen isquémico o no isquémico menores de 68 años considerando una disposición a pagar 25.000 euros/AVAC. En pacientes no isquémicos mayores, la razón de coste-efectividad incremental estimada se sitúa alrededor de los 30.000 euros/AVAC (AU)

Introduction and objective: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain.Methods: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital.Results: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66–0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years.Conclusions: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY (AU)

Daily sitting time and its association with non-communicable diseases and multimorbidity in Catalonia.

BACKGROUND: Non-communicable diseases (NCDs) account for 71% of deaths worldwide and individual behaviours such as sedentariness play an important role on their development and management. However, the detrimental effect of daily sitting on multiple NCDs has rarely been studied. This study sought (i) to investigate the association between sitting time and main NCDs and multimorbidity in the population of Catalonia and (ii) to explore the effect of physical activity as a modifier of the associations between sitting time and health outcomes. METHODS: Cross-sectional data from the 2016 National Health Survey of Catalonia were analyzed, and multivariable logistic regression, adjusting for socio-demographics and individual risk factors (tobacco and alcohol consumption, diet, hyperlipidaemia, hypertension, body mass index) was used to estimated odds ratios (ORs) and 95% confidence intervals (CIs) of the association between sitting time and NCDs. RESULTS: A total of 3320 people ≥15 years old were included in the study. Sitting more than 5 h/day was associated with a higher risk of cardiovascular disease (OR 1.90, 95% CI: 1.21-2.97), respiratory disease (OR 1.61, 95% CI: 1.13-2.30) and multimorbidity (OR 2.80, 95% CI: 1.53-5.15). Sitting more than 3 h/day was also associated with a higher risk of multimorbidity (OR 2.26, 95% CI: 1.23-4.16). Physical activity did not modify the associations between sitting time and any of the outcomes. CONCLUSIONS: Daily sitting time might be an independent risk factor for some NCDs, such as cardiovascular disease, respiratory disease and multimorbidity, independently of the level risk of physical inactivity.

Cost-effectiveness of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death.

INTRODUCTION AND OBJECTIVES: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain. METHODS: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital. RESULTS: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66-0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years. CONCLUSIONS: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY.

Measuring Older Peoples' Experiences of Person-Centred Coordinated Care: Experience and Methodological Reflections from Applying a Patient Reported Experience Measure in SUSTAIN.

INTRODUCTION: While several evaluation studies on (cost-)effectiveness of integrated care have been conducted in recent years, more insight is deemed necessary into integrated care from the perspective of service users. In the context of a European project on integrated care for older people living at home (SUSTAIN), this paper shares the experience and methodological reflections from applying a Patient Reported Experience Measure (PREM) on person-centred coordinated care -the P3CEQ- among this population. METHODS: A combination of quantitative and qualitative data and analysis methods was used to assess the usability and the quality of applying a PREM among older people presenting complex care needs, using the P3CEQ delivery in SUSTAIN as a case study. 228 service users completed the P3CEQ and nine SUSTAIN researchers participated in a consultation about their experience administering the questionnaire. P3CEQ scores were analysed quantitatively using principal component analysis and multilevel linear regression. P3CEQ open responses and researcher notes collected when administering the questionnaire were thematically analysed. RESULTS: Service user inclusion was high and most P3CEQ items had low non-response rates. Quantitative analysis and researcher experience indicate the relevance of face-to-face administration for obtaining such an amount of data in this population group. The presence of a carer increased inclusion of more vulnerable respondents, such as the cognitively impaired, but posed a challenge in data interpretation. Although several P3CEQ items were generally understood as intended by questionnaire developers, the analysis of open responses highlights how questions can lead to diverging and sometimes narrow interpretations by respondents. Cognitive impairment and a higher educational attainment were associated with lower levels of perceived person-centredness of care. CONCLUSION: This study shows essential preconditions to meaningfully collect and analyse PREM data on older peoples' experiences with integrated care: face-to-face administration away from care providers, collection of reasons for non-response and open comments providing nuances to answers, and multilevel modelling taking into account diversity in the target population. Several areas of improvement for future PREM use in this population have been identified: use of administration and coding guides, inclusion of clear and easy to understand definitions and examples illustrating what questions do and do not mean, measures of the expectations of person-centred coordinated care, and procedures ensuring sound ethical research. These methodological learnings can enhance future evaluation of integrated care from a service user perspective.

Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

Systematic review on abdominal aortic aneurysm screening cost-efficiency and methodological quality assessment.

INTRODUCTION: Abdominal aortic aneurysm (AAA) is a silent, progressive disease that can lead to death. It is easily diagnosed with noninvasive methods and its routine treatment has excellent results. This creates an optimal situation for population screening programs. The aim of this paper was to assess results and methodological quality of cost-utility studies on screening versus no screening scenarios for AAA to assess future establishment of new AAA screening programs. EVIDENCE ACQUISITON: A systematic review of efficiency (cost-effectiveness and cost-utility) studies was performed, finally selecting cost-utility studies on AAA screening versus no screening. Papers were selected that dealt with efficiency of screening for AAA according to PICOTS framework and the methodological quality assessed according to the economic evaluation analyses described by Drummond and Caro. Two independent reviewers were involved in the procedure. EVIDENCE SYNTHESIS: Research retrieved 88 studies. From those, 26 showed cost-effectiveness and cost-utility results. Finally, 10 studies had cost-utility results and suited criteria (published in the last 10 years; time-horizon: 10 years or more) for exhaustive analysis. All publications, except one, showed adequate incremental cost-utility ratios according to different national perspectives. Methodological assessment showed some quality limitations, but the majority of items analyzed were favorably answered after applying the questionnaires. CONCLUSIONS: Confirmation of the cost-utility results in this revision at a national/regional level should be the basis for the implantation of new national screening programs worldwide. The methodological evaluation applied in this revision is crucial for the corresponding future piggy-back trials to assess routine application of national AAA screening programs.

Once años de evaluaciones económicas de productos sanitarios en la Red de Agencias de Evaluación. Calidad metodológica e impacto del coste-utilidad / Eleven years of economic evaluations of medical devices by the Spanish Network of Assessment Agencies. Methodological quality and cost-utility impact

OBJETIVO: Analizar la calidad y el impacto de los análisis de coste-utilidad de productos sanitarios realizados por la Red de Agencias de Evaluación (RedETS). MÉTODO: Los análisis de coste-utilidad de productos sanitarios se identificaron buscando entre los informes de evaluación de la base de datos de la web de RedETS (2006-2016). La calidad se evaluó con un listado de verificación de calidad de RedETS, y su impacto, comparando resultados de coste-utilidad y la inclusión en la cartera común de servicios del Sistema Nacional de Salud. Se analizó la inclusión en la cartera común si la ratio de coste-efectividad incremental superaba o no los 25.000 € por año de vida ajustado por calidad. RESULTADOS: Se encontraron 25 análisis de coste-utilidad de productos sanitarios (12 de coste-utilidad, 10 de coste-efectividad y 3 de ambos). De ellos, 15 estudios con 19 ratios de coste-utilidad seleccionados cumplían al menos 18 de 25 criterios de verificación. Asimismo, 12 de los 15 estudios cumplían 18 de los 25 criterios. Sobre el impacto, en 6 de los 19 resultados se incluyó el producto en cartera aunque la ratio superó los 25.000 € por año de vida ajustado por calidad. En tres casos se está en proceso de reevaluación; en otro, de replanteamiento una vez realizados los informes de eficacia-seguridad de nuevos dispositivos; y en dos casos se señala en la cartera que debe seguirse un protocolo. CONCLUSIONES: La mayoría de los análisis de coste-utilidad de productos sanitarios analizados cumplieron casi todos los ítems del listado de verificación y, por tanto, fueron exhaustivos. Estos análisis de coste-utilidad de productos sanitarios fueron coherentes con el marco de toma de decisiones para manejar eficientemente la cartera del Sistema Nacional de Salud

OBJECTIVE: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS). METHOD: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years. RESULTS: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required. CONCLUSIONS: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio

Impact of comorbidity on the short- and medium-term risk of revision in total hip and knee arthroplasty.

BACKGROUND: The impact of comorbidity on the risk of revision in patients undergoing Total Knee arthroplasty (TKA) and Total Hip Arthroplasty (THA) is not currently well known. The aim of this study was to analyze the impact of comorbidity on the risk of revision in TKA and THA. METHODS: Patients recorded in the Catalan Arthroplasty Register (RACat) between 01/01/2005 and 31/12/2016 undergoing TKA (n = 49,701) and THA (n = 17,923) caused by osteoarthritis were included. As main explanatory factors, comorbidity burden was assessed by the Elixhauser index, categorized, and specific comorbidities from the index were taken into account. Descriptive analyses for comorbidity burden and specific conditions were done. Additionally, incidence at 1 and 5 years' follow-up was calculated, and adjusted Competing Risks models were fitted. RESULTS: A higher incidence of revision was observed when the number of comorbidities was high, both at 1 and 5 years for THA, but only at 1 year for TKA. Of the specific conditions, only obesity was related to the incidence of revision at 1 year in both joints, and at 5 years in TKA. The risk of revision was related to deficiency anemia and liver diseases in TKA, while in THA, it was related to peripheral vascular disorders, metastatic cancer and psychoses. CONCLUSIONS: Different conditions, depending on the joint, might be related to higher revision rates. This information could be relevant for clinical decision-making, patient-specific information and improving the results of both TKA and THA.

Relationship Between Depression and the Use of Mobile Technologies and Social Media Among Adolescents: Umbrella Review.

BACKGROUND: Despite the relevance of mobile technologies and social media (MTSM) for adolescents, their association with depressive disorders in this population remains unclear. While there are previous reviews that have identified the use of MTSM as a risk factor for developing depression, other reviews have indicated their possible preventive effect. OBJECTIVE: The aim of this review was to synthesize the current evidence on the association between MTSM use and the development or prevention of depressive disorders in adolescents. METHODS: An umbrella review was conducted using information published up to June 2019 from PubMed/MEDLINE, PsycINFO, Web of Science, and The Cochrane Library. Systematic reviews focusing on the adolescent population (up to 20 years old) and depression and its potential relationship with MTSM use were included. Screening of titles, abstracts, and full texts was performed. After selecting the reviews and given the heterogeneity of the outcome variables and exposures, a narrative synthesis of the results was carried out. RESULTS: The search retrieved 338 documents, from which 7 systematic reviews (3 meta-analyses) were selected for data extraction. There were 11-70 studies and 5582-46,015 participants included in the 7 reviews. All reviews included quantitative research, and 2 reviews also included qualitative studies. A statistically significant association between social media and developing depressive symptoms was reported in 2 reviews, while 5 reviews reported mixed results. CONCLUSIONS: Excessive social comparison and personal involvement when using MTSM could be associated with the development of depressive symptomatology. Nevertheless, MTSM might promote social support and even become a point of assistance for people with depression. Due to the mixed results, prospective research could be valuable for providing stronger evidence.

Differences in Results and Related Factors Between Hospital-at-Home Modalities in Catalonia: A Cross-Sectional Study.

Hospital-at-home (HaH) is a healthcare modality that provides active treatment by healthcare staff in the patient's home for a condition that would otherwise require hospitalization. The aims were to describe the characteristics of different types of hospital-at-home (HaH), assess their results, and examine which factors could be related to these results. A cross-sectional study based on data from all 2014 HaH contacts from Catalonia was designed. The following HaH modalities were considered-admission avoidance (n = 7,214; 75.1%) and early assisted discharge (n = 2,387; 24.9%). The main outcome indicators were readmission, mortality, and length of stay (days). Multivariable models were fitted to assess the association between explanatory factors and outcomes. Hospital admission avoidance is a scheme in which, instead of being admitted to acute care hospitals, patients are directly treated in their own homes. Early assisted discharge is a scheme in which hospital in-care patients continue their treatment at home. In the hospital avoidance modality, there were 8.3% readmissions, 0.9% mortality, and a mean length of stay (SD) of 9.6 (10.6) days. In the early assisted discharge modality, these figures were 7.9%, 0.5%, and 9.8 (11.1), respectively. In both modalities, readmission and mean length of stay were related to comorbidity and type of hospital, and mortality with age. The results of HaH in Catalonia are similar to those observed in other contexts. The factors related to these results identified might help to improve the effectiveness and efficiency of the different HaH modalities.

A Mobile Phone Intervention to Improve Obesity-Related Health Behaviors of Adolescents Across Europe: Iterative Co-Design and Feasibility Study.

BACKGROUND: Promotion of physical activity, healthy eating, adequate sleep, and reduced sedentary behavior in adolescents is a major priority globally given the current increase in population health challenges of noncommunicable diseases and risk factors such as obesity. Adolescents are highly engaged with mobile technology, but the challenge is to engage them with mobile health (mHealth) technology. Recent innovations in mobile technology provide opportunities to promote a healthy lifestyle in adolescents. An increasingly utilized approach to facilitate increased engagement with mHealth technology is to involve potential users in the creation of the technology. OBJECTIVE: This study aimed to describe the process of and findings from co-designing and prototyping components of the PEGASO Fit for Future (F4F) mHealth intervention for adolescents from different cultural backgrounds. METHODS: A total of 74 adolescents aged 13 to 16 years from Spain, Italy, and the United Kingdom participated in the co-design of the PEGASO F4F technology. In 3 iterative cycles over 12 months, participants were involved in the co-design, refinement, and feasibility testing of a system consisting of diverse mobile apps with a variety of functions and facilities to encourage healthy weight-promoting behaviors. In the first iteration, participants attended a single workshop session and were presented with mock-ups or early-version prototypes of different apps for user requirements assessment and review. During the second iteration, prototypes of all apps were tested by participants for 1 week at home or school. In the third iteration, further developed prototypes were tested for 2 weeks. Participants' user experience feedback and development ideas were collected through focus groups and completion of questionnaires. RESULTS: For the PEGASO F4F technology to be motivating and engaging, participants suggested that it should (1) allow personalization of the interface, (2) have age-appropriate and easy-to-understand language (of icons, labels, instructions, and notifications), (3) provide easily accessible tutorials on how to use the app or navigate through a game, (4) present a clear purpose and end goal, (5) have an appealing and self-explanatory reward system, (6) offer variation in gamified activities within apps and the serious game, and (7) allow to seek peer support and connect with peers for competitive activities within the technology. CONCLUSIONS: Incorporating adolescents' preferences, the PEGASO F4F technology combines the functions of a self-monitoring, entertainment, advisory, and social support tool. This was the first study demonstrating that it is possible to develop a complex mobile phone-based technological system applying the principles of co-design to mHealth technology with adolescents across 3 countries. The findings from this study informed the development of an mHealth system for healthy weight promotion to be tested in a controlled multinational pilot trial.

Implementation of the individual placement and support pilot program in Spain.

OBJECTIVE: This article describes the adoption of Individual Placement and Support (IPS) supported employment between 2013 and 2017 in Catalonia (Spain) in the context of high unemployment and a predominance of traditional preemployment training approaches. It reports the experience of implementing IPS to promote competitive job placement of people with mental disorders. METHOD: The Avedis Donabedian Research Institute (FAD) designed, trained, implemented, and evaluated the project. We used a longitudinal, mixed-methods approach. RESULTS: The demonstration project comprised 7 employment services and 12 ambulatory mental health centers. It followed up programs and participants from October 2013 to December 2017. The project added 1,188 new competitive jobs, increased the rate of competitive employment from 16% to 43%, and improved the fidelity of IPS by 44% on the organizational dimension and by 34% on services dimension. The quality of employment was similar to the overall employment market, with 94% of temporary jobs. The qualitative analysis confirmed several areas of improvement, including the vision of recovery, collaborations between vocational and mental health services, work patterns of practitioners, and views of work as an important treatment. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: A strong leadership team, consistent training, and commitment to model fidelity have established IPS in the pilot region as an important intervention to obtain and maintain competitive employment and recovery for people with a mental health condition. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

[Eleven years of economic evaluations of medical devices by the Spanish Network of Assessment Agencies. Methodological quality and cost-utility impact]. / Once años de evaluaciones económicas de productos sanitarios en la Red de Agencias de Evaluación. Calidad metodológica e impacto del coste-utilidad.

OBJECTIVE: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS). METHOD: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years. RESULTS: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required. CONCLUSIONS: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio.

Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial.

BACKGROUND: Behaviour change interventions targeting physical activity, diet, sleep and sedentary behaviour of teenagers show promise when delivered through smartphones. However, to date there is no evidence of effectiveness of multicomponent smartphone-based interventions. Utilising a user-centred design approach, we developed a theory-based, multi-dimensional system, PEGASO Fit For Future (PEGASO F4F), which exploits sophisticated game mechanics involving smartphone applications, a smartphone game and activity sensors to motivate teenagers to take an active role in adopting and maintaining a healthy lifestyle. This paper describes the study protocol to assess the feasibility, usability and effectiveness (knowledge/awareness and behavioural change in lifestyle) of the PEGASO system. METHODS: We are conducting a quasi-experimental controlled cluster trial in 4 sites in Spain, Italy, and UK (England, Scotland) over 6 months. We plan to recruit 525, in a 2:1 basis, teenagers aged 13-16 years from secondary schools. The intervention group is provided with the PEGASO system whereas the comparison group continues their usual educational routine. Outcomes include feasibility, acceptance, and usability of the PEGASO system as well as between and within group changes in motivation, self-reported diet, physical activity, sedentary and sleeping behaviour, anthropometric measures and knowledge about a healthy lifestyle. DISCUSSION: PEGASO F4F will provide evidence into the cross-cultural similarities and differences in the feasibility, acceptability and usability of a multi-dimensional smartphone based behaviour change intervention for teenagers. The study will explore facilitating factors, challenges and barriers of engaging teenagers to adapt and maintain a healthy lifestyle when using smartphone technology. Positive results from this ICT based multi component intervention may have significant implications both at clinical level, improving teenagers health and at public health level since it can present an influential tool against the development of chronic disease during adulthood. TRIAL REGISTRATION: https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.

Hospitalización domiciliaria sustitutiva del ingreso y facilitadora del alta: resultados y factores relacionados / Early-discharge and admission-avoidance hospital-at-home programs: outcomes and associated factors

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