GATEKEEPER's Strategy for the Multinational Large-Scale Piloting of an eHealth Platform: Tutorial on How to Identify Relevant Settings and Use Cases.

BACKGROUND: The World Health Organization's strategy toward healthy aging fosters person-centered integrated care sustained by eHealth systems. However, there is a need for standardized frameworks or platforms accommodating and interconnecting multiple of these systems while ensuring secure, relevant, fair, trust-based data sharing and use. The H2020 project GATEKEEPER aims to implement and test an open-source, European, standard-based, interoperable, and secure framework serving broad populations of aging citizens with heterogeneous health needs. OBJECTIVE: We aim to describe the rationale for the selection of an optimal group of settings for the multinational large-scale piloting of the GATEKEEPER platform. METHODS: The selection of implementation sites and reference use cases (RUCs) was based on the adoption of a double stratification pyramid reflecting the overall health of target populations and the intensity of proposed interventions; the identification of a principles guiding implementation site selection; and the elaboration of guidelines for RUC selection, ensuring clinical relevance and scientific excellence while covering the whole spectrum of citizen complexities and intervention intensities. RESULTS: Seven European countries were selected, covering Europe's geographical and socioeconomic heterogeneity: Cyprus, Germany, Greece, Italy, Poland, Spain, and the United Kingdom. These were complemented by the following 3 Asian pilots: Hong Kong, Singapore, and Taiwan. Implementation sites consisted of local ecosystems, including health care organizations and partners from industry, civil society, academia, and government, prioritizing the highly rated European Innovation Partnership on Active and Healthy Aging reference sites. RUCs covered the whole spectrum of chronic diseases, citizen complexities, and intervention intensities while privileging clinical relevance and scientific rigor. These included lifestyle-related early detection and interventions, using artificial intelligence-based digital coaches to promote healthy lifestyle and delay the onset or worsening of chronic diseases in healthy citizens; chronic obstructive pulmonary disease and heart failure decompensations management, proposing integrated care management based on advanced wearable monitoring and machine learning (ML) to predict decompensations; management of glycemic status in diabetes mellitus, based on beat to beat monitoring and short-term ML-based prediction of glycemic dynamics; treatment decision support systems for Parkinson disease, continuously monitoring motor and nonmotor complications to trigger enhanced treatment strategies; primary and secondary stroke prevention, using a coaching app and educational simulations with virtual and augmented reality; management of multimorbid older patients or patients with cancer, exploring novel chronic care models based on digital coaching, and advanced monitoring and ML; high blood pressure management, with ML-based predictions based on different intensities of monitoring through self-managed apps; and COVID-19 management, with integrated management tools limiting physical contact among actors. CONCLUSIONS: This paper provides a methodology for selecting adequate settings for the large-scale piloting of eHealth frameworks and exemplifies with the decisions taken in GATEKEEPER the current views of the WHO and European Commission while moving forward toward a European Data Space.

Playing with fruit: An experimental study to test the effectiveness of an online memory advergame to promote children's fruit consumption.

OBJECTIVE: Literature on food marketing targeting young people reveals that in the last years, sophisticated marketing techniques have been developed to market predominantly unhealthy food products. Much research has been conducted to test the impact of these techniques on subsequent product selection and intake. Less is known about the effects of promoting healthier foods, although the health-related benefits of eating more fruit and vegetables for children are important. The main aim of the present experiment was to examine if an online advergame promoting a fruit brand with food products increased subsequent fruit intake by children. METHODS: We used a randomized between-subject design with 123 children (age: 7-13 years) who played an advergame that promoted fruit (n = 43), non-food products (n = 40), or were in the control condition (n = 40). Subsequently, we measured the free intake of fruit as main outcome. RESULTS: Playing the advergame promoting fruit did not stimulate the subsequent intake of fruit. Children in the advergame with fruit ate similar amounts of fruit than children in the control condition. No moderation effects of BMI, hunger, sex and game attitude were found. In addition, Bayesian analyses have been conducted that support the null hypothesis. DISCUSSION: Previous research has shown that marketing of unhealthy products via advergames affects subsequent intake of the promoted product, but the same effect is not found for healthier foods. We suggest that future research should examine if longer exposure or different forms of novel food marketing are effective in increasing the intake of healthier foods. Until now, it is unclear if advergames as a marketing technique for healthy foods have the same effectiveness on the intake of healthier food products.

Effect of Source Type and Protective Message on the Critical Evaluation of News Messages on Facebook: Randomized Controlled Trial in the Netherlands.

BACKGROUND: Disinformation has become an increasing societal concern, especially due to the speed that news is shared in the digital era. In particular, disinformation in the health care sector can lead to serious casualties, as the current COVID-19 crisis clearly shows. OBJECTIVE: The main aim of this study was to experimentally examine the effects of information about the source and a protective warning message on users' critical evaluation of news items, as well as the perception of accuracy of the news item. METHODS: A 3 (unreliable vs reliable vs no identified source) × 2 (with protective message vs without) between-subject design was conducted among 307 participants (mean age 29 (SD 10.9] years). RESULTS: The results showed a significant effect of source information on critical evaluation. In addition, including a protective message did not significantly affect critical evaluation. The results showed no interaction between type of source and protective message on critical evaluation. CONCLUSIONS: Based on these results, it is questionable whether including protective messages to improve critical evaluation is a way to move forward and improve critical evaluation of health-related news items, although effective methodologies to tackle the spread of disinformation are highly needed. TRIAL REGISTRATION: ClinicalTrials.gov NCT05030883; https://clinicaltrials.gov/ct2/show/NCT05030883.

Cost-utility analysis of a consensus and evidence-based medication review to optimize and potentially reduce psychotropic drug prescription in institutionalized dementia patients.

BACKGROUND: Growing evidence shows the effects of psychotropic drugs on the evolution of dementia. Until now, only a few studies have evaluated the cost-effectiveness of psychotropic drugs in institutionalized dementia patients. This study aims to assess the cost-utility of intervention performed in the metropolitan area of Barcelona (Spain) (MN) based on consensus between specialized caregivers involved in the management of dementia patients for optimizing and potentially reducing the prescription of inappropriate psychotropic drugs in this population. This analysis was conducted using the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing (MAFEIP) tool. METHODS: The MAFEIP tool builds up from a variety of surrogate endpoints commonly used across different studies in order to estimate health and economic outcomes in terms of incremental changes in quality adjusted life years (QALYs), as well as health and social care utilization. Cost estimates are based on scientific literature and expert opinion; they are direct costs and include medical visits, hospital care, medical tests and exams and drugs administered, among other concepts. The healthcare costs of patients using the intervention were calculated by means of a medication review that compared patients' drug-related costs before, during and after the use of the intervention conducted in MN between 2012 and 2014. The cost-utility analysis was performed from the perspective of a health care system with a time horizon of 12 months. RESULTS: The tool calculated the incremental cost-effectiveness ratio (ICER) of the intervention, revealing it to be dominant, or rather, better (more effective) and cheaper than the current (standard) care. The ICER of the intervention was in the lower right quadrant, making it an intervention that is always accepted even with the lowest given Willingness to Pay (WTP) threshold value (€15,000). CONCLUSIONS: The results of this study show that the intervention was dominant, or rather, better (more effective) and cheaper than the current (standard) care. This dominant intervention is therefore recommended to interested investors for systematic application.

Guided Internet-Based Cognitive Behavioral Therapy for Depression: Implementation Cost-Effectiveness Study.

BACKGROUND: Major depressive disorder is a chronic condition; its prevalence is expected to grow with the aging trend of high-income countries. Internet-based cognitive-behavioral therapy has proven efficacy in treating major depressive disorder. OBJECTIVE: The objective of this study was to assess the cost-effectiveness of implementing a community internet-based cognitive behavioral therapy intervention (Super@, the Spanish program for the MasterMind project) for treating major depressive disorder. METHODS: The cost-effectiveness of the Super@ program was assessed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, using a 3-state Markov model. Data from the cost and effectiveness of the intervention were prospectively collected from the implementation of the program by a health care provider in Badalona, Spain; the corresponding data for usual care were gathered from the literature. The health states, transition probabilities, and utilities were computed using Patient Health Questionnaire-9 scores. RESULTS: The analysis was performed using data from 229 participants using the Super@ program. Results showed that the intervention was more costly than usual care; the discounted (3%) and nondiscounted incremental cost-effectiveness ratios were €29,367 and €26,484 per quality-adjusted life-year, respectively (approximately US $35,299 and $31,833, respectively). The intervention was cost-effective based on the €30,000 willingness-to-pay threshold typically applied in Spain (equivalent to approximately $36,060). According to the deterministic sensitivity analyses, the potential reduction of costs associated with intervention scale-up would reduce the incremental cost-effectiveness ratio of the intervention, although it remained more costly than usual care. A discount in the incremental effects up to 5% exceeded the willingness-to-pay threshold of €30,000. CONCLUSIONS: The Super@ program, an internet-based cognitive behavioral therapy intervention for treating major depressive disorder, cost more than treatment as usual. Nevertheless, its implementation in Spain would be cost-effective from health care and societal perspectives, given the willingness-to-pay threshold of €30,000 compared with treatment as usual.

An mHealth intervention for the treatment of patients with an eating disorder: A multicenter randomized controlled trial.

OBJECTIVE: The current multicentre randomized controlled trial assessed the clinical efficacy of a combined mHealth intervention for eating disorders (EDs) based on cognitive behavioral therapy (CBT). METHOD: A total of 106 ED patients from eight different public and private mental health services in Spain were randomly assigned to two parallel groups. Patients of the experimental group (N = 53) received standard face-to-face CBT plus a mobile intervention through an application called "TCApp," which provides self-monitoring and an online chat with the therapist. The control group (N = 53) received standard face-to-face CBT only. Patients completed self-report questionnaires on ED symptomatology, anxiety, depression, and quality of life, before and after treatment. RESULTS: Significant reductions in primary and secondary outcomes were observed for participants of both groups, with no differences between groups. Results also suggested that the frequency with which patients attended their referral mental health institution after the intervention was lower for patients in the experimental group than for those in the control group. DISCUSSION: The current study showed that CBT can help to reduce symptoms relating to ED, regardless of whether its delivery includes online components in addition to traditional face-to-face treatment. Besides, the additional component offered by the TCApp does not appear to be promising from a purely therapeutic perspective but perhaps as a cost-effective tool, reducing thus the costs and time burden associated with weekly visits to health professionals.

Promoting healthy foods in the new digital era on Instagram: an experimental study on the effect of a popular real versus fictitious fit influencer on brand attitude and purchase intentions.

BACKGROUND: Most studies on social influencer marketing techniques have focused on the promotion of unhealthy foods whereas little is known about the promotion of healthier foods. The present experimental study investigated whether a popular real versus fictitious fit influencer is more successful in promoting healthy food products. In addition, we examined the role of parasocial interaction as an underlying mechanism of healthy food product endorsement. METHODS: We used a randomized between-subject design with 154 participants (mean age: 24.0 years). Viewers' product attitude and purchase intention were tested after exposure to an Instagram post by a popular real fit influencer (n = 77) or fictitious fit influencer (n = 77). RESULTS: Results showed that parasocial interaction mediated the relation between the type of influencer and product attitude as well as purchase intention. Parasocial interaction was higher for participants exposed to the popular real fit influencer compared to the fictitious fit influencer, leading to higher healthy food brand attitude and purchase intention. DISCUSSION: The findings showed that it is crucial for social influencers to establish a warm personal relationship and connection with the their followers when promoting a healthy product successfully. We suggest that the promotion of healthy foods could be more successful in public health when using popular fit influencers.

Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial.

BACKGROUND: During the last few decades, preventing the development of cardiovascular disease has become a mainstay for reducing cardiovascular morbidity and mortality. It has been suggested that interventions should focus more on committed approaches of self-care, such as electronic health techniques. OBJECTIVE: This study aimed to provide evidence to understand the financial consequences of implementing the "Do Cardiac Health: Advanced New Generation Ecosystem" (Do CHANGE 2) intervention, which was evaluated in a multisite randomized controlled trial to change the health behavior of patients with cardiovascular disease. METHODS: The cost-effectiveness analysis of the Do CHANGE 2 intervention was performed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, based on a Markov model of five health states. The following two types of costs were considered for both study groups: (1) health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities). RESULTS: The Do CHANGE 2 intervention was less costly in Spain (incremental cost was -€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively). Compared with treatment as usual, the effectiveness of the Do CHANGE 2 program in terms of an increase in quality-adjusted life-year gains was slightly higher in the Netherlands and lower in Spain and Taiwan. CONCLUSIONS: In general, we found that the incremental cost-effectiveness ratio strongly varied depending on the country where the intervention was applied. The Do CHANGE 2 intervention showed a positive cost-effectiveness ratio only when implemented in Spain, indicating that it saved financial costs in relation to the effect of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305.

Systematically testing the effects of promotion techniques on children's fruit and vegetables intake on the long term: a protocol study of a multicenter randomized controlled trial.

BACKGROUND: Eating a diet rich in fruit and vegetables is essential for healthy development, protects against chronicle diseases, and increases mental well-being. Numerous studies have consistently shown that children do not consume enough fruit and vegetables, especially among children from low socioeconomic status, while foods high in fat, sugar and salt are over-consumed. In order to improve children's eating behavior, there is an urgent need to systematically test novel and effective methods to make fruit and vegetables more appealing and increase the intake among children. Therefore, the main aim of the proposed project is to test if food promotion techniques increase children's fruit and vegetable intake, both on the short- and long-term. METHODS: Three studies will be conducted. First, to develop the vlogs in co-creation, multiple focus groups will be held with (1) children (N = 25, between 8 and 13 years), (2) parents (N = 10), (3) vloggers (N = 5), and (4) fruit and vegetable producers and marketers (N = 5). Second, a multicenter randomized clinical trial will be conducted among 10 primary schools. A mixed repeated measure design with three different conditions will be used: (1) control, (2) a vlog unboxing fruit and vegetables (preparing and tasting), and (3) a vlog doing a challenge with the fruit and vegetables (e.g., contests, tricks, games). Children between 7 and 13 will participate in the experiments (N = 350). Third, after 6 and 12 months follow-up measurements will take place. DISCUSSION: HFSS foods have higher intrinsically rewarding properties that make them more "wanted" and "liked" than fruit and vegetables, thereby inducing unhealthy eating behavior among children. Additionally, promotion for HFSS foods is omnipresent and increases the rewarding value of these foods. Moreover, some studies showed that the promotion of fruit and vegetables affects the intake, although a recent systematic review shows that evidence is inconclusive and a theoretical understanding for the underlying mechanism is missing. The current study aims to improve the existing knowledge by experimentally testing a newly developed theoretical model. TRIAL REGISTRATION: Netherlands Trial registration: NL8077, received on 12 October 2019.

The effect of a memory-game with images of vegetables on children's vegetable intake: An experimental study.

OBJECTIVE: Currently, children consume too much energy-dense snack food and not enough fruits and vegetables, thereby increasing their risk of developing chronic diseases. The aim of the present experiment was to examine if priming children with images of diverse vegetables by means of a memory game increased subsequent vegetable intake. METHODS: We conducted a randomized between-subject design with 100 children (age: 7-12 y) who played a memory-game, containing images of either vegetables (n = 47) or non-food items (n = 53). Free intake of vegetables served during the experiment session was measured. The children reported their gender, age and hunger upon arrival, and their height and weight were measured at the end of the experiment. RESULTS: Playing the memory-game containing vegetables did not stimulate vegetable intake. Children in the vegetable memory-game condition ate similar amounts of vegetables than children in the control condition. No moderation effects of BMI, baseline hunger, gender and game attitude were found. DISCUSSION: Unlike previous experiments in children observing increase in unhealthy food consumption subsequent to its promotion, we found no effect on immediate vegetable intake of priming children with images of vegetables. Additional research is needed to address the difficulty to enhance vegetable intake in children.

Cognitive Therapy for Dementia Patients: A Systematic Review.

BACKGROUND: Cognitive therapy is a well-established intervention for treating elderly suffering from dementia. In particular, reality orientation and skills training seem to be effective interventions for reversing cognitive impairment among elderly, although findings are inconclusive. Therefore, a systematic update of the existing evidence of cognitive therapy for people suffering from dementia is needed. AIM: To review existing scientific evidence regarding the efficacy of cognitive therapies for elderly suffering from dementia. METHODS: Studies were retrieved from several bibliographic databases (January 2009 to December 2017) with prespecified selection criteria, data extraction, and methodological quality assessment. RESULTS: In total, 10 reality orientation, 25 skills training, and 12 mixed trials were identified as meeting the inclusion criteria and were systematically reviewed. Results from reality orientation trials showed minor effects for cognitive assessments, while skills training trials and mixed trials showed contradicting effects on cognition. Effects on other outcomes (e.g., daily functioning, depression, language) were limited or not found. CONCLUSIONS: Skills training trials and mixed trials seem to affect cognitive impairment in a positive way, although the results are inconclusive. Comparison between studies was difficult due to differences in form of intervention. Because findings are inconclusive, more structuralized and comparable randomized controlled trials are needed.

The persuasive effect of advergames promoting unhealthy foods among children: A meta-analysis.

Multiple studies have examined the effects of advergames promoting unhealthy foods on eating behavior among children. Although the individual results of the existing studies suggest that advergames have a significant influence on (predictors of) eating behavior, a lack of clarity concerning the size of the effect may impede policy actions. Therefore, a meta-analysis was conducted to examine the strength of the effect of playing advergames that promote unhealthy foods on (predictors of) eating behavior among children. Five electronic databases were searched for relevant publications (Web of Science, PsychInfo, Pubmed, JSTOR, and SCOPUS). Fifteen articles were considered eligible for inclusion and analyzed in the meta-analysis. Employing a random-effects model to estimate the composite effect of advergames yielded a small-to-moderate and significant effect of g = 0.30. Results showed that advergames promoting unhealthy foods induced unhealthy eating behavior among children. Although only a limited number of studies were included, this meta-analysis supports public health policy action that seeks to reduce children's exposure to unhealthy digital food marketing. Stricter regulation to protect children against new forms of (online) marketing techniques that promote unhealthy foods should be developed and implemented.

Investigating the impact of a health game on implicit attitudes towards food and food choice behaviour of young adults.

Improving diets by stimulating fruit and vegetable consumption might be beneficial, in particular when they substitute energy-dense products. The aim of present study was to investigate whether a health game can be used to positively affect healthy implicit attitudes (IAs) towards food and subsequent food choice behaviour of young adults. A 2 (Time: baseline vs. post-test) x 2 (Condition: health game vs. control game) x 2 (Baseline IAs: healthy IAs vs. less healthy IAs) mixed-subjects design was used with 125 participants (age: M = 20.17, SD = 1.88). IAs towards food were assessed at baseline and post-test using an Implicit Association Test (IAT). Additionally, food choice behaviour was assessed after game play. At baseline, the majority of participants had healthy IAs (i.e., favouring fruit over chocolate snacks). At post-test, significantly less healthy IAs were observed in the control condition, while this reduction was not significant in the health game condition. Regarding food choice behaviour, participants with healthy baseline IAs were more likely to select fruit in the health game condition than participants with healthy baseline IAs in the control game condition. However, participants with less healthy baseline IAs were less likely to select fruit in the health game condition than in the control condition. We found tentative support that health games can be used to influence IAs towards food and positively affect food choice behaviour. However, this influence was only observed for those with healthy baseline IAs. The current version of the health game would primarily benefit those already healthy and could negatively affect those that need the intervention most, so modifications are recommendable.

A systematic review of mHealth interventions for the support of eating disorders.

OBJECTIVE: To systematically review the existing evidence of mobile health (mHealth) tools for the treatment of eating disorders (ED). METHOD: Electronic databases (Pubmed, PsycInfo, and SCOPUS) were searched, and PRISMA guidelines were followed. Selected studies were divided into three categories according to the intended purpose of the mHealth tools used: (a) sole means of support, (b) complementary to standard face-to-face treatment, and (c) for relapse prevention. Additionally, studies were assessed on efficacy, qualitative information, and methodological quality. RESULTS: Fifteen studies were identified. Most studies using mHealth as a sole means of intervention or adjunct to traditional therapy showed no effects, although an improvement at postassessment was present in vodcast, smartphone application, and text-messaging interventions. Between group effects were only found for a text-messaging intervention for relapse prevention. Qualitative analyses showed that most mHealth interventions were considered as acceptable, supporting, and motivating by patients and therapists, although different important problems were observed in individual studies. CONCLUSIONS: Limited effects were found for mHealth interventions to reduce ED-related symptoms. A common evaluation framework for ED mHealth interventions should be proposed to assess the validity of interventions before implementing them on a larger scale in clinical practice.

Does a 'protective' message reduce the impact of an advergame promoting unhealthy foods to children? An experimental study in Spain and The Netherlands.

The weight of evidence points to the advertising of food affecting food consumption, especially among children. Such advertising often promotes unhealthy foods. Current policy deliberations focus on developing effective 'protective' messages to increase advertising literacy and consequent scepticism about advertising targeting children. This study examined whether incorporating a 'protective' message in an advergame promoting energy-dense snacks would reduce children's snack intake. A randomized between-subject design was conducted in the Netherlands (N = 215) and Spain (N = 382) with an advergame promoting either energy-dense snacks or nonfood products. The results showed that playing an advergame promoting energy-dense snacks increased caloric intake in both countries, irrespective of whether the 'protective' message was present or not. These results point to the limitations of 'protective' messages and advertising literacy and provide policy makers with a rationale for extending the current prohibition of food advertising to young children in the terrestrial media to online environments.

The association between BMI development among young children and (un)healthy food choices in response to food advertisements: a longitudinal study.

BACKGROUND: Previous studies have focused on the acute effects of food advertisements on the caloric intake of children; however, the long-term effects of this food cue reactivity on weight gain have not been examined. The main aim of this study was to explore if reactivity to food cues in an advertisement was associated with weight status two years later. METHODS: Children wo had previously taken part in an experiment investigating the impact of advergames on food intake had their height and weight re-measured two years later, for assessment of body mass index (BMI). A within-subject design was used to test the associations between food choices and BMI over time. In the previous experiment, children played an advergame that promoted energy-dense snacks, fruit, or nonfood products, or did not play an advergame (control condition). After playing the game, the free intake of energy-dense snacks and fruits was measured. RESULTS: Children who ate more apple after playing an advergame promoting energy-dense snacks had a lower BMI two years later. Consumption of energy-dense snacks after playing an advergame promoting energy-dense snacks was not associated with BMI two years later. In other condition, no association was found between food intake and BMI after two years . CONCLUSIONS: The findings suggest that coping with environmental cues that trigger unhealthy eating behavior is associated with the body mass index of young children two years later. This might imply that learning to respond to food cues by choosing healthy options might prevent children from excessive weight gain. This trial was registered at as ISRCTN17013832 .

The role of attentional bias in the effect of food advertising on actual food intake among children.

This study examined the potential moderating role of attentional bias (i.e., gaze duration, number of fixations, latency of initial fixation) in the effect of advergames promoting energy-dense snacks on children's snack intake. A randomized between-subject design was conducted with 92 children who played an advergame that promoted either energy-dense snacks or nonfood products. Eye movements and reaction times to food and nonfood cues were recorded to assess attentional bias during playtime using eye-tracking methods. Children could eat freely after playing the game. The results showed that playing an advergame containing food cues increased total intake. Furthermore, children with a higher gaze duration for the food cues ate more of the advertised snacks. In addition, children with a faster latency of initial fixation to the food cues ate more in total and ate more of the advertised snacks. The number of fixations on the food cues did not increase actual snack intake. Food advertisements are designed to grab attention, and this study shows that the extent to which a child's attention is directed to a food cue increases the effect of the advertisement.

Digital Remote Monitoring Using an mHealth Solution for Survivors of Cancer: Protocol for a Pilot Observational Study.

BACKGROUND: Healthy lifestyle interventions have a positive impact on multiple disease trajectories, including cancer-related outcomes. Specifically, appropriate habitual physical activity, adequate sleep, and a regular wholesome diet are of paramount importance for the wellness and supportive care of survivors of cancer. Mobile health (mHealth) apps have the potential to support novel tailored lifestyle interventions. OBJECTIVE: This observational pilot study aims to assess the feasibility of mHealth multidimensional longitudinal monitoring in survivors of cancer. The primary objective is to test the compliance (user engagement) with the monitoring solution. Secondary objectives include recording clinically relevant subjective and objective measures collected through the digital solution. METHODS: This is a monocentric pilot study taking place in Bangor, Wales, United Kingdom. We plan to enroll up to 100 adult survivors of cancer not receiving toxic anticancer treatment, who will provide self-reported behavioral data recorded via a dedicated app and validated questionnaires and objective data automatically collected by a paired smartwatch over 16 weeks. The participants will continue with their normal routine surveillance care for their cancer. The primary end point is feasibility (eg, mHealth monitoring acceptability). Composite secondary end points include clinically relevant patient-reported outcome measures (eg, the Edmonton Symptom Assessment System score) and objective physiological measures (eg, step counts). This trial received a favorable ethical review in May 2023 (Integrated Research Application System 301068). RESULTS: This study is part of an array of pilots within a European Union funded project, entitled "GATEKEEPER," conducted at different sites across Europe and covering various chronic diseases. Study accrual is anticipated to commence in January 2024 and continue until June 2024. It is hypothesized that mHealth monitoring will be feasible in survivors of cancer; specifically, at least 50% (50/100) of the participants will engage with the app at least once a week in 8 of the 16 study weeks. CONCLUSIONS: In a population with potentially complex clinical needs, this pilot study will test the feasibility of multidimensional remote monitoring of patient-reported outcomes and physiological parameters. Satisfactory compliance with the use of the app and smartwatch, whether confirmed or infirmed through this study, will be propaedeutic to the development of innovative mHealth interventions in survivors of cancer. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52957.

A systematic review on experimental studies about patient adherence to treatment.

A better understanding of patients' adherence to treatment is a prerequisite to maximize the benefit of healthcare provision for patients, reduce treatment costs, and is a key factor in a variety of subsequent health outcomes. We aim to understand the state of the art of scientific evidence about which factors influence patients' adherence to treatment. A systematic literature review was conducted using PRISMA guidelines in five separate electronic databases of scientific publications: PubMed, PsycINFO (ProQuest), Cochrane library (Ovid), Google Scholar, and Web of Science. The search focused on literature reporting the significance of factors in adherence to treatment between 2011 and 2021, including only experimental studies (e.g., randomized controlled trials [RCT], clinical trials, etc.). We included 47 experimental studies. The results of the systematic review (SR) are grouped according to predetermined categories of the World Health Organization (WHO): socioeconomic, treatment, condition, personal, and healthcare-related factors. This review gives an actual overview of evidence-based studies on adherence and analyzed the significance of factors defined by the WHO classification. By showing the strength of certain factors in several independent studies and concomitantly uncovering gaps in research, these insights could serve as a basis for the design of future adherence studies and models.

The impact of labour market shocks on mental health: evidence from the Covid-19 first wave.

In this study, we estimate the effect of a negative labour market shock on individuals' levels of stress, anxiety, and depression. We use a dataset collected during the first wave of the Covid-19 pandemic, on a representative sample of citizens from Italy, Spain, and the United Kingdom, interviewed on three occasions. We measure stress, anxiety and depression and labour shocks using validated scales. Our research design is a standard difference-in-differences model: we leverage the differential timing of shocks to identify the impact on mental health. In our estimations, a negative labour shock increases the measure of stress, anxiety, and depression by 16% of a standard deviation computed from the baseline.