Selection of criteria for a telemedicine framework for designing, implementing, monitoring and evaluating telemedicine interventions: Validation using a modified Delphi process.

Objectives: The call to scale up telemedicine services globally as part of the digital health transformation lacks an agreed-upon set of constructs to guide the implementation process. A lack of guidance hinders the development, consolidation, sustainability and optimisation of telemedicine services. The study aims to reach consensus among telemedicine experts on a set of implementation constructs to be developed into an evidence-based support tool. Methods: A modified Delphi study was conducted to evaluate a set of evidence-informed telemedicine implementation constructs comprising cores, domains and items. The study evaluated the constructs consisting of five cores: Assessment of the Current Situation, Development of a Telemedicine Strategy, Development of Organisational Changes, Development of a Telemedicine Service, and Monitoring, Evaluation and Optimisation of Telemedicine Implementation; seven domains: Individual Readiness, Organisational Readiness, Clinical, Economic, Technological and Infrastructure, Regulation, and Monitoring, Evaluation and Optimisation; divided into 53 items. Global telemedicine specialists (n = 247) were invited to participate and evaluate 58 questions. Consensus was set at ≥70%. Results: Forty-five experts completed the survey. Consensus was reached on 78% of the constructs evaluated. Regarding the core constructs, Monitoring, Evaluation and Optimisation of Telemedicine Implementation was determined to be the most important one, and Development of a Telemedicine Strategy the least. As for the domains, the Clinical one had the highest level of consensus, and the Economic one had the lowest. Conclusions: This research advances the field of telemedicine, providing expert consensus on a set of implementation constructs. The findings also highlight considerable divergence in expert opinion on the constructs of reimbursement and incentive mechanisms, resistance to change, and telemedicine champions. The lack of agreement on these constructs warrants attention and may partly explain the barriers that telemedicine services continue to face in the implementation process.

Spanish and Catalan Versions of the eHealth Literacy Questionnaire: Translation, Cross-Cultural Adaptation, and Validation Study.

BACKGROUND: The rise of digital health services, especially following the outbreak of COVID-19, has led to a need for health literacy policies that respond to people's needs. Spain is a country with a highly developed digital health infrastructure, but there are currently no tools available to measure digital health literacy fully. A well-thought-through questionnaire with strong psychometric properties such as the eHealth Literacy Questionnaire (eHLQ) is important to assess people's eHealth literacy levels, especially in the context of a fast-growing field such as digital health. OBJECTIVE: This study aims to adapt the eHLQ and gather evidence of its psychometric quality in 2 of Spain's official languages: Spanish and Catalan. METHODS: A systematic cultural adaptation process was followed. Data from Spanish-speaking (n=400) and Catalan-speaking (n=400) people were collected. Confirmatory factor analysis was used to confirm the previously established factor structure. For reliability, the Cronbach α and categorical ω were obtained for every subscale. Evidence of convergent and discriminant validity was provided through the correlation with the total score of the eHealth Literacy Scale. Evidence based on relations to other variables was evaluated by examining extreme values for educational level, socioeconomic level, and use of technology variables. RESULTS: Regarding the confirmatory factor analysis, the 7-factor correlated model and the 7 one-factor models had adequate goodness-of-fit indexes for both Spanish and Catalan. Moreover, measurement invariance was established between the Spanish and Catalan versions. Reliability estimates were considered adequate as all the scales in both versions had values of >0.80. For convergent and discriminant validity evidence, the eHealth Literacy Scale showed moderate correlation with eHLQ scales in both versions (Spanish: range 0.57-0.76 and P<.001; Catalan: range 0.41-0.64 and P<.001). According to the relationship with external variables, all the eHLQ scales in both languages could discriminate between the maximum and minimum categories in level of education, socioeconomic level, and level of technology use. CONCLUSIONS: The Spanish and Catalan versions of the eHLQ appear to be psychometrically sound questionnaires for assessing digital health literacy. They could both be useful tools in Spain and Catalonia for researchers, policy makers, and health service managers to explore people's needs, skills, and competencies and provide interesting insights into their interactions and engagement regarding their own experiences with digital health services, especially in the context of digital health growth in Spain.

Efficacy, Safety, and Evaluation Criteria of mHealth Interventions for Depression: Systematic Review.

BACKGROUND: Depression is a significant public health issue that can lead to considerable disability and reduced quality of life. With the rise of technology, mobile health (mHealth) interventions, particularly smartphone apps, are emerging as a promising approach for addressing depression. However, the lack of standardized evaluation tools and evidence-based principles for these interventions remains a concern. OBJECTIVE: In this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of mHealth interventions for depression and identify the criteria and evaluation tools used for their assessment. METHODS: A systematic review and meta-analysis of the literature was carried out following the recommendations of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Studies that recruited adult patients exhibiting elevated depressive symptoms or those diagnosed with depressive disorders and aimed to assess the effectiveness or safety of mHealth interventions were eligible for consideration. The primary outcome of interest was the reduction of depressive symptoms, and only randomized controlled trials (RCTs) were included in the analysis. The risk of bias in the original RCTs was assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials. RESULTS: A total of 29 RCTs were included in the analysis after a comprehensive search of electronic databases and manual searches. The efficacy of mHealth interventions in reducing depressive symptoms was assessed using a random effects meta-analysis. In total, 20 RCTs had an unclear risk of bias and 9 were assessed as having a high risk of bias. The most common element in mHealth interventions was psychoeducation, followed by goal setting and gamification strategies. The meta-analysis revealed a significant effect for mHealth interventions in reducing depressive symptoms compared with nonactive control (Hedges g=-0.62, 95% CI -0.87 to -0.37, I2=87%). Hybrid interventions that combined mHealth with face-to-face sessions were found to be the most effective. Three studies compared mHealth interventions with active controls and reported overall positive results. Safety analyses showed that most studies did not report any study-related adverse events. CONCLUSIONS: This review suggests that mHealth interventions can be effective in reducing depressive symptoms, with hybrid interventions achieving the best results. However, the high level of heterogeneity in the characteristics and components of mHealth interventions indicates the need for personalized approaches that consider individual differences, preferences, and needs. It is also important to prioritize evidence-based principles and standardized evaluation tools for mHealth interventions to ensure their efficacy and safety in the treatment of depression. Overall, the findings of this study support the use of mHealth interventions as a viable method for delivering mental health care. TRIAL REGISTRATION: PROSPERO CRD42022304684; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=304684.

Identifying Activities from an Intervention to Promote Sleep in Hospitalised Patients Using the Focus Mapping Technique.

BACKGROUND: Sleep is an essential element for patients' recovery during a period of hospitalisation. Hospital Clínic de Barcelona has developed the ClíNit project to promote patients' sleep by identifying elements that affect the quality of sleep and implementing actions to improve rest at night. OBJECTIVE: Our aim is to select actions to improve sleep quality. METHODS: The study population included night-shift nurses from two clinical units where the pilot actions were to be carried out (n: 14). The nurses prioritised actions to improve sleep quality using the methodology proposed by Fogg: clarification, magic wand, crispification, and the focus-mapping technique. RESULTS: Two sessions were organised for each unit and 32 actions considered high impact and easy to implement were proposed, of which 43.75% (14/32) were directly dependent on nurses. It was then agreed to implement four of these pilot studies. CONCLUSIONS: One aspect worth highlighting is that using prioritization techniques such as the Fogg technique is a good strategy to implement the general objectives of intervention programmes in large organizations in an easy way.

Correction: Evaluation Criteria for Weight Management Apps: Validation Using a Modified Delphi Process.

[This corrects the article DOI: 10.2196/16899.].

Correction: Assessment of the Efficacy, Safety, and Effectiveness of Weight Control and Obesity Management Mobile Health Interventions: Systematic Review.

[This corrects the article DOI: 10.2196/12612.].

Barriers and facilitators for safe sex behaviors in students from universidad de Santiago de Chile (USACH) through the COM-B model.

BACKGROUND: Unsafe sex is one of the main morbidity and mortality risk factors associated with sexually transmitted infections (STIs) in young people. Behavioral change interventions for promoting safe sex have lacked specificity and theoretical elements about behavior in their designs, which may have affected the outcomes for HIV/AIDS and STI prevention, as well as for safe sex promotion. This study offers an analysis of the barriers and facilitators that, according to the university students who participated in the focus groups, impede or promote the success of interventions promoting healthy sexuality from the perspective of the actions stakeholders should undertake. In turn, this study proposes intervention hypotheses based on the Behavior Change Wheel which appears as a useful strategy for the design of intervention campaigns. METHODS: Two focus groups were organized with students from Universidad de Santiago de Chile (USACH). The focus groups gathered information about the perceptions of students about sex education and health, risk behaviors in youth sexuality, and rating of HIV/AIDS and STI prevention campaigns. In the focus groups, participants were offered the possibility of presenting solutions for the main problems and limitations detected. After identifying the emerging categories related to each dimension, a COM-B analysis was performed, identifying both the barriers and facilitators of safe sex behaviors that may help orient future interventions. RESULTS: Two focus groups were organized, which comprised 20 participants with different sexual orientations. After transcription of the dialogues, a qualitative analysis was performed based on three axes: perception about sex education, risk behaviors, and evaluation of HIV/AIDS and STI prevention campaigns. These axes were classified into two groups: barriers or facilitators for safe and healthy sexuality. Finally, based on the Behavior Change Wheel and specifically on its 'intervention functions', the barriers and facilitators were integrated into a series of actions to be taken by those responsible for promotion campaigns at Universidad de Santiago. The most prevalent intervention functions are: education (to increase the understanding and self-regulation of the behavior); persuasion (to influence emotional aspects to promote changes) and training (to facilitate the acquisition of skills). These functions indicate that specific actions are necessary for these dimensions to increase the success of promotional campaigns for healthy and safe sexuality. CONCLUSIONS: The content analysis of the focus groups was based on the intervention functions of the Behavior Change Wheel. Specifically, the identification by students of barriers and facilitators for the design of strategies for promoting healthy sexuality is a useful tool, which when complemented with other analyses, may contribute improving the design and implementation of healthy sexuality campaigns among university students.

The Current Status of Telemedicine Technology Use Across the World Health Organization European Region: An Overview of Systematic Reviews.

BACKGROUND: Several systematic reviews evaluating the use of telemedicine by clinicians, patients, and health authorities to improve the delivery of care in the 53 member states of the World Health Organization (WHO) European Region have been conducted in recent years. However, a study summarizing the findings of these reviews has not been conducted. OBJECTIVE: This overview of systematic reviews aimed to summarize findings regarding the use of telemedicine across the 53 member states and identify the medical fields and levels of care in and at which the effectiveness, feasibility, and applicability of telemedicine have been demonstrated. The barriers to and facilitators of telemedicine use were also evaluated and collated to help with the design and implementation of telemedicine interventions. METHODS: Through a comprehensive systematic evaluation of the published and unpublished literature, we extracted clinical, epidemiological, and technology-related data from each review included in the study. We focused on evaluating the barriers to and facilitators of the use of telemedicine apps across the 53 member states considered. We rated the methodological quality of each of the included reviews based on A Measurement Tool to Assess Systematic Review 2 approach and judged the overall certainty of evidence by using the Grading of Recommendations, Assessment, Development, and Evaluations methodology. The entire process was performed by 2 independent authors. RESULTS: This overview drew on data from >2239 primary studies, with >20,000 enrolled patients in total, within the WHO European Region. On the basis of data from randomized trials, observational studies, and economic evaluations from several countries, the results show a clear benefit of telemedicine technologies in the screening, diagnosis, management, treatment, and long-term follow-up of a series of chronic diseases. However, we were unable to pool the results into a reliable numeric parameter because of the high heterogeneity of intervention methodologies, scheduling, primary study design discrepancies, settings, and geographical locations. In addition to the clinical outcomes of the interventions, the social and economic outcomes are highlighted. CONCLUSIONS: The application of telemedicine is well established across countries in the WHO European Region; however, some countries could still benefit from the many uses of these digital solutions. Barriers related to users, technology, and infrastructure were the largest. Conversely, the provision of health services using technological devices was found to significantly enhance patients' clinical outcomes, improve the long-term follow-up of patients by medical professionals, and offer logistical benefits for both patients and health workers. TRIAL REGISTRATION: PROSPERO (International Prospective Register of Systematic Reviews) CRD42022309375; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=309375.

Codesign and Feasibility Testing of a Tool to Evaluate Overweight and Obesity Apps.

BACKGROUND: Digital health interventions and mobile technologies can help to reduce the rates of obesity and overweight conditions. Although weight management apps are widely used, they usually lack professional content and evaluation, so the quality of these apps cannot be guaranteed. The EVALAPPS project aims to design and validate a tool to assess the safety and effectiveness of health-related apps whose main goal is to manage and prevent obesity and overweight conditions. OBJECTIVE: The aim of this paper is two-fold: (a) to co-create and codesign the EVALAPPS assessment tool and (b) to pilot its feasibility among overweight and obese individuals that use weight control apps. METHODS: A mixed-methods approach was used. A multidisciplinary team (n = 12) participated in a co-creation workshop to provide proposals and inputs about the look and feel of the content, usability aspects, appearance, sections, and main features of the EVALAPPS tool. The tool was tested for its feasibility among 31 overweight and obese individuals, attending the CP Endocrinologia i Nutrició SL Clinic for the first time. Participants were asked to use a specific weight control app [Yazio (YAZIO GmbH, Erfurt, Germany), My FitnessPal (MyFitnessPal, Austin, TX, USA) or MyPlate (MyPlate, Santa Monica, CA, USA)] for two weeks and then evaluate them by using the EVALAPPS (EVALAPPS, David Ganyan, Barcelona, Spain) (June 2020, David Ganyan, Barcelona, Spain) tool. Seven participants were phone interviewed to gain more insight into the use of the EVALAPPS tool. RESULTS: The co-creation workshop allowed conceptualizing the EVALAPPS tool. The feasibility study showed that all criteria from the Usability and Functionality dimensions had valid answers, while Reliability, Security, Privacy, and Health indicators were the dimensions with less valid answers. In all three apps, the dimension with the highest score was Usability/functionality, followed by app purpose. Clinical effectiveness and Development were the dimensions with the lowest scores in all three tested weight control apps. CONCLUSIONS: The participation of the multidisciplinary team and end-users in the conceptualization and testing of a tool to assess health apps was feasible and relevant for the usability of the tool.

Mobile Applications in Mood Disorders and Mental Health: Systematic Search in Apple App Store and Google Play Store and Review of the Literature.

OBJECTIVES: The main objective of this work was to explore and characterize the current landscape of mobile applications available to treat mood disorders such as depression, bipolar disorder, and dysthymia. METHODS: We developed a tool that makes both the Apple App Store and the Google Play Store searchable using keywords and that facilitates the extraction of basic app information of the search results. All app results were filtered using various inclusion and exclusion criteria. We characterized all resultant applications according to their technical details. Furthermore, we searched for scientific publications on each app's website and PubMed, to understand whether any of the apps were supported by any type of scientific evidence on their acceptability, validation, use, effectiveness, etc. Results: Thirty apps were identified that fit the inclusion and exclusion criteria. The literature search yielded 27 publications related to the apps. However, these did not exclusively concern mood disorders. 6 were randomized studies and the rest included a protocol, pilot-, feasibility, case-, or qualitative studies, among others. The majority of studies were conducted on relatively small scales and 9 of the 27 studies did not explicitly study the effects of mobile application use on mental wellbeing. CONCLUSION: While there exists a wealth of mobile applications aimed at the treatment of mental health disorders, including mood disorders, this study showed that only a handful of these are backed by robust scientific evidence. This result uncovers a need for further clinically oriented and systematic validation and testing of such apps.

Estudio sobre telemedicina internacional en América Latina: motivaciones, usos, resultados, estrategias y políticas / Study on international telemedicine in Latin America: motivations, uses, results, strategies and policies

Este trabajo presenta una identificación de las principales cuestiones relacionadas con el desarrollo de la telemedicina, en especial políticas, aspectos regulatorios y legales, y problemas de salud susceptibles de ser abordados mediante el uso de la telemedicina en América Latina. Seguidamente realiza una identificación de los factores que impulsan y debilitan el comercio internacional de telemedicina en América Latina y el Caribe y delinea recomendaciones estratégicas y de política pública que impulsen la adopción de la telemedicina internacional en la región

Relationship of problematic cannabis use among youth in Spain with perceived risk, environmental factors and sociodemographic factors. / Relación del consumo problemático de cannabis en la población joven de España con el riesgo percibido, los factores ambientales y los factores sociodemográficos.

The relationship of problematic cannabis consumption with perceived risk, socioenvironmental and sociodemographic factors among youth in Spain is not well known. The aims of this study are: 1) to describe the patterns of cannabis consumption (problematic and non-problematic) in Spanish youth, and 2) to explore whether problematic cannabis consumption is related to perceived risk, environmental factors and individual sociodemographic characteristics. A cross-sectional design based on data from the 2015/16 Spanish Household Survey on Alcohol and Drugs (EDADES) was performed. Individuals between 15 and 35 years old having used cannabis during the last year with a complete Cannabis Abuse Screening Test (CAST) were included (N = 1,674). Problematic consumption (CAST >= 7) was considered as dependent variable. Perceived risk, environmental factors (availability of the substance and exposure to consumption situations) and sociodemographic factors were taken as independent variables. Descriptive analyses of consumption patterns were performed and univariable and multivariable Poisson regression models were done. All analyses were stratified by gender. Problematic cannabis consumption was more frequent among men (38.9 %) than among women (23.2 %). While among men, problematic use was related to environmental factors and educational level, among women it was associated with perceived risk and unemployment. Problematic cannabis consumption among Spanish youth is associated with different types of gender-related factors. Due to its representativeness at the population level and the validity of the measures, these results might have important implications on the development of prevention strategies targeted at problematic cannabis consumption.

La relación entre el consumo problemático de cannabis, el riesgo percibido y los factores socioambientales y sociodemográficos no es clara actualmente. Los objetivos del estudio son: describir los patrones de consumo de cannabis (problemático y no problemático) en la población joven de España y explorar como el consumo problemático se relaciona con el riesgo percibido, y los factores ambientales y sociodemográficos. Se llevó a cabo un diseño transversal basado en datos de la edición de 2015/2016 de la Encuesta Domiciliaria sobre Alcohol y Drogas (EDADES). La encuesta incluyó participantes de entre 15 y 35 años que habían consumido cannabis en al menos una ocasión durante el último año y que completaron el Cannabis Abuse Screening Test (CAST) (N = 1674). Se consideró el consumo problemático (CAST >= 7) como variable dependiente. Como variables independientes se consideraron el riesgo percibido, los factores ambientales (disponibilidad de la sustancia y exposición a situaciones de consumo) y los factores sociodemográficos. Se llevaron a cabo análisis descriptivos de los patrones de consumo y se realizaron modelos univariables y multivariables de Poisson. Todos los análisis se estratificaron por género. El consumo problemático fue más frecuente en hombres (38,9 %) que en mujeres (23,2 %). Mientras en hombres el consumo problemático se relacionó con factores ambientales y nivel educativo, en mujeres se asoció con riesgo percibido y desempleo. Dada la representatividad de los datos y la validez de las medidas, estos resultados podrían tener importantes implicaciones para el desarrollo de medidas preventivas contra el consumo problemático de cannabis.

Relación del consumo problemático de cannabis en la población joven de España con el riesgo percibido, los factores ambientales y los factores sociodemográficos / Relationship of problematic cannabis use among youth in Spain with perceived risk, environmental factors and sociodemographic factors

La relación entre el consumo problemático de cannabis, el riesgo percibido y los factores socioambientales y sociodemográficos no es clara actualmente. Los objetivos del estudio son: describir los patrones de consumo de cannabis (problemático y no problemático) en la población joven de España y explorar como el consumo problemático se relaciona con el riesgo percibido, y los factores ambientales y sociodemográficos. Se llevó a cabo un diseño transversal basado en datos de la edición de 2015/2016 de la Encuesta Domiciliaria sobre Alcohol y Drogas (EDADES). La encuesta incluyó participantes de entre 15 y 35 años que habían consumido cannabis en al menos una ocasión durante el último año y que completaron el Cannabis Abuse Screening Test (CAST) (N = 1674). Se consideró el consumo problemático (CAST >= 7) como variable dependiente. Como variables independientes se consideraron el riesgo percibido, los factores ambientales (disponibilidad de la sustancia y exposición a situaciones de consumo) y los factores sociodemográficos. Se llevaron a cabo análisis descriptivos de los patrones de consumo y se realizaron modelos univariables y multivariables de Poisson. Todos los análisis se estratificaron por género. El consumo problemático fue más frecuente en hombres (38,9 %) que en mujeres (23,2 %). Mientras en hombres el consumo problemático se relacionó con factores ambientales y nivel educativo, en mujeres se asoció con riesgo percibido y desempleo. Dada la representatividad de los datos y la validez de las medidas, estos resultados podrían tener importantes implicaciones para el desarrollo de medidas preventivas contra el consumo problemático de cannabis

The relationship of problematic cannabis consumption with perceived risk, socioenvironmental and sociodemographic factors among youth in Spain is not well known. The aims of this study are: 1) to describe the patterns of cannabis consumption (problematic and non-problematic) in Spanish youth, and 2) to explore whether problematic cannabis consumption is related to perceived risk, environmental factors and individual sociodemographic characteristics. A cross-sectional design based on data from the 2015/16 Spanish Household Survey on Alcohol and Drugs (EDADES) was performed. Individuals between 15 and 35 years old having used cannabis during the last year with a complete Cannabis Abuse Screening Test (CAST) were included (N = 1,674). Problematic consumption (CAST >= 7) was considered as dependent variable. Perceived risk, environmental factors (availability of the substance and exposure to consumption situations) and sociodemographic factors were taken as independent variables. Descriptive analyses of consumption patterns were performed and univariable and multivariable Poisson regression models were done. All analyses were stratified by gender. Problematic cannabis consumption was more frequent among men (38.9 %) than among women (23.2 %). While among men, problematic use was related to environmental factors and educational level, among women it was associated with perceived risk and unemployment. Problematic cannabis consumption among Spanish youth is associated with different types of gender-related factors. Due to its representativeness at the population level and the validity of the measures, these results might have important implications on the development of prevention strategies targeted at problematic cannabis consumption

Mobile Health Strategies to Tackle Skin Neglected Tropical Diseases With Recommendations From Innovative Experiences: Systematic Review.

BACKGROUND: Neglected tropical diseases (NTDs) represent a diverse group of 20 communicable diseases that occur in tropical and subtropical areas in 149 countries, affecting over 1 billion people and costing developing economies billions of dollars every year. Within these diseases, those that present lesions on the skin surface are classified as skin NTDs (sNTDs). Mobile health interventions are currently being used worldwide to manage skin diseases and can be a good strategy in the epidemiological and clinical management of sNTDs. OBJECTIVE: We aimed to analyze existing evidence about mobile health interventions to control and manage sNTDs in low- and middle-income countries (LMICs) and make recommendations for what should be considered in future interventions. METHODS: A systematic review was conducted of the MEDLINE, Embase, and Scopus databases over 10 years up to April 30, 2020. All types of clinical studies were considered. Data were synthesized into evidence tables. Apps were selected through a comprehensive systematic search in the Google Play Store and Apple App Store conducted between March 20 and April 15, 2020. RESULTS: From 133 potentially relevant publications, 13 studies met our criteria (9.8%). These analyzed eight different interventions (three SMS text messaging interventions and five app interventions). Six of the 13 (46%) studies were community-based cross-sectional studies intended to epidemiologically map a specific disease, mainly lymphatic filariasis, but also cutaneous leishmaniasis, leprosy, and NTDs, as well as sNTDs in general. Most of the studies were considered to have a high (5/13, 39%) or moderate (4/13, 31%) risk of bias. Fifteen apps were identified in the Google Play Store, of which three were also in the Apple App Store. Most of the apps (11/15, 73%) were targeted at health care professionals, with only four targeted at patients. The apps focused on scabies (3/15, 20%), lymphatic filariasis (3/15, 20%), cutaneous leishmaniasis (1/15, 7%), leprosy (1/15, 7%), yaws and Buruli ulcer (1/15, 7%), tropical diseases including more than one sNTDs (3/15, 20%), and NTDs including sNTDs (2/15, 13%). Only 1 (7%) app focused on the clinical management of sNTDs. CONCLUSIONS: All mobile health interventions that were identified face technological, legal, final user, and organizational issues. There was a remarkable heterogeneity among studies, and the majority had methodological limitations that leave considerable room for improvement. Based on existing evidence, eight recommendations have been made for future interventions.

Evaluation Criteria for Weight Management Apps: Validation Using a Modified Delphi Process.

BACKGROUND: The use of apps for weight management has increased over recent years; however, there is a lack of evidence regarding the efficacy and safety of these apps. The EVALAPPS project will develop and validate an assessment instrument to specifically assess the safety and efficacy of weight management apps. OBJECTIVE: The aim of this study was to reach a consensus among stakeholders on a comprehensive set of criteria to guide development of the EVALAPPS assessment instrument. A modified Delphi process was used in order to verify the robustness of the criteria that had been identified through a literature review and to prioritize a set of the identified criteria. METHODS: Stakeholders (n=31) were invited to participate in a 2-round Delphi process with 114 initial criteria that had been identified from the literature. In round 1, participants rated criteria according to relevance on a scale from 0 ("I suggest this criterion is excluded") to 5 ("This criterion is extremely relevant"). A criterion was accepted if the median rating was 4 or higher and if the relative intraquartile range was equal to 0.67 or lower. In round 2, participants were asked about criteria that had been discarded in round 1. A prioritization strategy was used to identify crucial criteria according to (1) the importance attributed by participants (criteria with a mean rating of 4.00 or higher), (2) the level of consensus (criteria with a score of 4 or 5 by at least 80% of the participants). RESULTS: The response rate was 83.9% (26/31) in round 1 and 90.3% (28/31) in round 2. A total of 107 out of 114 criteria (93.9%) were accepted by consensus-105 criteria in round 1 and 2 criteria in round 2. After prioritization, 53 criteria were deemed crucial. These related mainly to the dimensions of security and privacy (13/53, 24.5%) and usability (9/53, 17.0%), followed by activity data (5/53, 9.4%), clinical effectiveness (5/53, 9.4%), and reliability (5/53, 9.4%). CONCLUSIONS: Results confirmed the robustness of the criteria that were identified, with those relating to security and privacy being deemed most relevant by stakeholders. Additionally, a specific set of criteria based on health indicators (activity data, physical state data, and personal data) was also prioritized.

Assessment of the Efficacy, Safety, and Effectiveness of Weight Control and Obesity Management Mobile Health Interventions: Systematic Review.

BACKGROUND: The use of apps to tackle overweight and obesity by tracking physical and dietary patterns and providing recommendations and motivation strategies to achieve personalized goals has increased over recent years. However, evidence of the efficacy, effectiveness, and safety of these apps is severely lacking. OBJECTIVE: The aim of this study was to identify efficacy, safety, and effectiveness criteria used to assess weight control, overweight, and obesity management in mobile health (mHealth) interventions through a systematic review. METHODS: PubMed, PsycINFO, Scopus, UK Trial Database, ClinicalTrials.gov, and the Cochrane Library were surveyed up to May 2018. All types of clinical studies were considered. A total of 2 independent reviewers assessed quality using Scottish Intercollegiate Guidelines Network (SIGN) criteria. Ratings were used to provide an overall score for each study (low, moderate, or high). Data were synthesized in evidence tables. RESULTS: From 233 potentially relevant publications, only 28 studies were included. Of these, 13 (46%) were randomized control trials, 11 were single-arm studies (39%), 3 were nonrandomized controlled trials (11%), and 1 study was a cluster randomized trial (4%). The studies were classified as low (15), high (7), and moderate (6) quality according to SIGN criteria. All studies focused on efficacy, with only 1 trial mentioning safety and another 1 effectiveness. In 11 studies, the apps were used as stand-alone interventions, the others were multicomponent studies that included other tools for support such as sensors or websites. The main management tool included in the apps was feedback messaging (24), followed by goal-setting mechanisms (20) and self-monitoring (19). The majority of studies took weight or body mass index loss as the main outcome (22) followed by changes in physical activity (14) and diet (12). Regarding outputs, usability, adherence, and engagement (17) were the most reported, followed by satisfaction (7) and acceptability (4). CONCLUSIONS: There is a remarkable heterogeneity among these studies and the majority have methodological limitations that leave considerable room for improvement. Further research is required to identify all relevant criteria for assessing the efficacy of mHealth interventions in the management of overweight and obesity. TRIAL REGISTRATION: PROSPERO CRD42017056761; https://tinyurl.com/y2zhxtjx.

Evaluation of the effectiveness of hip and knee implant models used in Catalonia: a protocol for a prospective registry-based study.

BACKGROUND: Monitoring results regarding the effectiveness of knee and hip arthroplasties may be useful at the clinical, economic and patient level and help reduce the number of prosthesis revisions. In Spain, and specifically in Catalonia, there is currently no systematic monitoring of the different prosthesis models available on the market. Within this context, the aim of the project presented in this protocol is to evaluate the short- and medium-term effectiveness of knee and hip models implanted in Catalonia and to identify where the results could be better or worse than expected. METHODS: A prospective observational design will be drawn up based on data from a population-based arthroplasty register for hip and knee replacements that includes data from 53 of the 61 public hospitals in Catalonia. The knee and hip prosthesis models used will be identified and classified according to the type of prosthesis, fixation and, in total hip replacements, the bearing surface. For the data analysis, two methodological approaches will be used sequentially: first, an approach based on a survival analysis, followed by an approach based on standardised revision ratios and funnel plots. Following the analyses, a panel of experts will evaluate the results to identify possible sources of bias. Lastly, those models with results better or worse than expected compared to those from the comparison group will be valued, and strengths and difficulties for routine implementation of this methodology within the Catalan Arthroplasty Register will be identified. DISCUSSION: The study presented in this protocol will allow us to identify the hip and knee prosthesis models whose results might be better or worse than expected. This information could have a potential impact at the patient, orthopaedic surgeon, healthcare manager, decision-making and industry levels, both in the short term and in the medium and long term.

Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project).

BACKGROUND: Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases. METHODS: This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice. DISCUSSION: This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases. TRIAL REGISTRATION: ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016.

[Development of a Conceptual Framework for the Assessment of Chronic Care in the Spanish National Health System]. / Desarrollo de un marco conceptual para la evaluación de la atención a la cronicidad en el sistema nacional de salud.

The aim was to develop a conceptual framework for the assessment of new healthcare initiatives on chronic diseases within the Spanish National Health System. A comprehensive literature review between 2002 and 2013, including systematic reviews, meta-analysis, and reports with evaluation frameworks and/or assessment of initiatives was carried out; integrated care initiatives established in Catalonia were studied and described; and semistructured interviews with key stakeholders were performed. The scope and conceptual framework were defined by using the brainstorming approach.Of 910 abstracts identified, a total of 116 studies were included. They referred to several conceptual frameworks and/or assessment indicators at a national and international level. An overall of 24 established chronic care initiatives were identified (9 integrated care initiatives); 10 in-depth interviews were carried out. The proposed conceptual framework envisages: 1)the target population according to complexity levels; 2)an evaluation approach of the structure, processes, and outcomes considering the health status achieved, the recovery process and the maintenance of health; and 3)the dimensions or attributes to be assessed. The proposed conceptual framework will be helpful has been useful to develop indicators and implement them with a community-based and result-oriented approach and a territorial or population-based perspective within the Spanish Health System. This will be essential to know which are the most effective strategies, what are the key elements that determine greater success and what are the groups of patients who can most benefit.

El objetivo del trabajo fue desarrollar un marco conceptual para la evaluación de nuevos programas de gestión clínica y asistencial de carácter integrado en el Sistema Nacional de Salud para la atención a las personas con enfermedades crónicas. Se realizó una revisión exhaustiva de la literatura entre 2002-2013 incluyendo revisiones sistemáticas, metaanálisis e informes con modelos de evaluación y/o evaluaciones de programas. Se estudiaron y describieron programas locales de atención a la cronicidad implementados en Cataluña y se realizaron entrevistas semiestructuradas con expertos clave en el ámbito catalán. El alcance y el marco conceptual se definieron mediante la técnica del brainstorming. De 910 resúmenes identificados, se incluyeron 116 documentos que se referían a marcos conceptuales e indicadores de evaluación a nivel español e internacional. Se identificaron 24 programas de atención a la cronicidad (9 de carácter integrado). El marco conceptual propuesto contempló: 1) la población diana según niveles de complejidad; 2) un enfoque de evaluación de la estructura, procesos y resultados teniendo en cuenta el estado de salud conseguido, el proceso de recuperación y mantenimiento de la salud; y 3) las dimensiones o atributos que se deben evaluar. El marco conceptual propuesto permite desarrollar indicadores e implementarlos con un enfoque comunitario, orientados a los resultados y tener una visión territorial o poblacional, que será imprescindible para saber cuál es la estrategia más efectiva, cuáles son los elementos que determinan un mayor éxito y cuáles son los grupos de pacientes que más se pueden beneficiar.

Desarrollo de un marco conceptual para la evaluación de la atención a la cronicidad en el Sistema Nacional del Salud / Development of a conceptual framework for the assessment of chronic care in the Sapanish National Health System

El objetivo del trabajo fue desarrollar un marco conceptual para la evaluación de nuevos programas de gestión clínica y asistencial de carácter integrado en el Sistema Nacional de Salud para la atención a las personas con enfermedades crónicas. Se realizó una revisión exhaustiva de la literatura entre 2002-2013 incluyendo revisiones sistemáticas, metaanálisis e informes con modelos de evaluación y/o evaluaciones de programas. Se estudiaron y describieron programas locales de atención a la cronicidad implementados en Cataluña y se realizaron entrevistas semiestructuradas con expertos clave en el ámbito catalán. El alcance y el marco conceptual se definieron mediante la técnica del brainstorming. De 910 resúmenes identificados, se incluyeron 116 documentos que se referían a marcos conceptuales e indicadores de evaluación a nivel español e internacional. Se identificaron 24 programas de atención a la cronicidad (9 de carácter integrado). El marco conceptual propuesto contempló: 1) la población diana según niveles de complejidad; 2) un enfoque de evaluación de la estructura, procesos y resultados teniendo en cuenta el estado de salud conseguido, el proceso de recuperación y mantenimiento de la salud; y 3) las dimensiones o atributos que se deben evaluar. El marco conceptual propuesto permitirá desarrollar indicadores e implementarlos con un enfoque comunitario, orientados a los resultados y tener una visión territorial o poblacional, que será imprescindible para saber cuál es la estrategia más efectiva, cuáles son los elementos que determinan un mayor éxito y cuáles son los grupos de pacientes que más se pueden beneficiar (AU)

The aim was to develop a conceptual framework for the assessment of new healthcare initiatives on chronic diseases within the Spanish National Health System. A comprehensive literature review between 2002 and 2013, including systematic reviews, meta-analysis, and reports with evaluation frameworks and/or assessment of initiatives was carried out; integrated care initiatives established in Catalonia were studied and described; and semistructured interviews with key stakeholders were performed. The scope and conceptual framework were defined by using the brainstorming approach. Of 910 abstracts identified, a total of 116 studies were included. They referred to several conceptual frameworks and/or assessment indicators at a national and international level. An overall of 24 established chronic care initiatives were identified (9 integrated care initiatives); 10 in-depth interviews were carried out. The proposed conceptual framework envisages: 1)the target population according to complexity levels; 2)an evaluation approach of the structure, processes, and outcomes considering the health status achieved, the recovery process and the maintenance of health; and 3)the dimensions or attributes to be assessed. The proposed conceptual framework will be helpful develop indicators and implement them with a community-based and result-oriented approach and a territorial or population-based perspective within the Spanish Health System. This will be essential to know which are the most effective strategies, what are the key elements that determine greater success and what are the groups of patients who can most benefit (AU)