Background: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for... Show moreBackground: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for themselves. In the FitKnip experiment, individuals were given access to a health app platform, where they could purchase reliable preselected health apps with a personal budget of €100 (US $107.35). By conducting a prospective study, we aimed to scientifically evaluate the FitKnip experiment as an innovative way to improve population health. Objective: The aim of the experiment was to scientifically evaluate the FitKnip experiment as an innovative way to improve population health. More specifically, we conducted an in-depth qualitative evaluation of the concept and acceptability of FitKnip, its perceived impact on health empowerment, as well as the roles of stakeholders for the future implementation of a health app platform through focus group interviews. Methods: This study followed a phenomenological research design and included 7 focus group interviews with end users and 1 with stakeholders, held between July and December 2020. End users were recruited through various institutions in the Netherlands, for example, insurance companies and local governments. All focus groups were semistructured using interview guides and were held via videoconferencing due to the COVID-19 pandemic measures. Each participant received access to a health app platform where they were enabled to purchase reliable, preselected health apps with a budget of €100 (US $107.35). The budget was valid for the entire research period. The health app platform offered 38 apps. A third party, a health care coalition, selected the apps to be included in FitKnip. The analyses were conducted according to the principles of the Framework Method. Results: A priori formulated themes were concept, acceptability, health empowerment, and outcomes, and the roles of stakeholders for the future implementation of a health app platform. Both end users (n=31) and stakeholders (n=5) were enthusiastic about the concept of a health app platform. End users indicated missing apps regarding physical health and lifestyle and needing more guidance toward suitable apps. End users saw health empowerment as a precondition to using a health app platform and achieving health outcomes depending on the purchased mobile apps. End users and stakeholders identified potential providers and financing parties of FitKnip. Stakeholders recommended the establishment of a reputable national or international quality guidelines or certification for health and wellbeing apps, that can demonstrate the quality and reliability of mobile health applications. Conclusions: This study showed the need for a personalized and flexible platform. Next to this, a deeper understanding of the roles of stakeholders in such initiatives is needed especially on financing and reimbursement of health promotion and digital health services. A personalized, flexible health app platform is a promising initiative to support individuals in their health. Show less
Hoogendoorn, P.; Versluis, A.; Kampen, S. van; McCay, C.; Leahy, M.; Bijlsma, M.; ... ; Chavannes, N.H. 2023
Background: The lack of an international standard for assessing and communicating health app quality and the lack of consensus about what makes a high-quality health app negatively affect the... Show moreBackground: The lack of an international standard for assessing and communicating health app quality and the lack of consensus about what makes a high-quality health app negatively affect the uptake of such apps. At the request of the European Commission, the international Standard Development Organizations (SDOs), European Committee for Standardization, International Organization for Standardization, and International Electrotechnical Commission have joined forces to develop a technical specification (TS) for assessing the quality and reliability of health and wellness apps.Objective: This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality.Methods: A 2-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42, 51%) or both (n=41, 49%) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the maximum 100 requirement questions for the uptake of apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries that participated in the SDO technical committees were invited to comment on 4 working drafts and subsequently vote on the TS.Results: The final quality assessment framework includes 81 questions, 67 (83%) of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as "Healthy and safe," "Easy to use," "Secure data," and "Robust build." The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2-4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs, including 6 of the 10 most populous countries worldwide.Conclusions: A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers enhance and efficiently demonstrate the quality of health apps, consumers, and health care professionals to make informed decisions on health apps. It will also help insurers to make reimbursement decisions on health apps. Show less
Willemsen, R.F.; Meijer, E.; Berg, L.N. van den; Burg, L. van der; Chavannes, N.H.; Aardoom, J.J. 2023
Background: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for... Show moreBackground: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for themselves. In the FitKnip experiment, individuals were given access to a health app platform, where they could purchase reliable preselected health apps with a personal budget of €100 (US $107.35). By conducting a prospective study, we aimed to scientifically evaluate the FitKnip experiment as an innovative way to improve population health.Objective: The aim of the experiment was to scientifically evaluate the FitKnip experiment as an innovative way to improve population health. More specifically, we conducted an in-depth qualitative evaluation of the concept and acceptability of FitKnip, its perceived impact on health empowerment, as well as the roles of stakeholders for the future implementation of a health app platform through focus group interviews.Methods: This study followed a phenomenological research design and included 7 focus group interviews with end users and 1 with stakeholders, held between July and December 2020. End users were recruited through various institutions in the Netherlands, for example, insurance companies and local governments. All focus groups were semistructured using interview guides and were held via videoconferencing due to the COVID-19 pandemic measures. Each participant received access to a health app platform where they were enabled to purchase reliable, preselected health apps with a budget of €100 (US $107.35). The budget was valid for the entire research period. The health app platform offered 38 apps. A third party, a health care coalition, selected the apps to be included in FitKnip. The analyses were conducted according to the principles of the Framework Method.Results: A priori formulated themes were concept, acceptability, health empowerment, and outcomes, and the roles of stakeholders for the future implementation of a health app platform. Both end users (n=31) and stakeholders (n=5) were enthusiastic about the concept of a health app platform. End users indicated missing apps regarding physical health and lifestyle and needing more guidance toward suitable apps. End users saw health empowerment as a precondition to using a health app platform and achieving health outcomes depending on the purchased mobile apps. End users and stakeholders identified potential providers and financing parties of FitKnip. Stakeholders recommended the establishment of a reputable national or international quality guidelines or certification for health and wellbeing apps, that can demonstrate the quality and reliability of mobile health applications.Conclusions: This study showed the need for a personalized and flexible platform. Next to this, a deeper understanding of the roles of stakeholders in such initiatives is needed especially on financing and reimbursement of health promotion and digital health services. A personalized, flexible health app platform is a promising initiative to support individuals in their health. Show less
Willemsen, R.F.; Meijer, E.; Berg, L.N. van den; Burg, L. van der; Chavannes, N.H.; Aardoom, J.J. 2023
Background: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for... Show moreBackground: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for themselves. In the FitKnip experiment, individuals were given access to a health app platform, where they could purchase reliable preselected health apps with a personal budget of euro100 (US $107.35). By conducting a prospective study, we aimed to scientifically evaluate the FitKnip experiment as an innovative way to improve population health.Objective: The aim of the experiment was to scientifically evaluate the FitKnip experiment as an innovative way to improve population health. More specifically, we conducted an in-depth qualitative evaluation of the concept and acceptability of FitKnip, its perceived impact on health empowerment, as well as the roles of stakeholders for the future implementation of a health app platform through focus group interviews.Methods: This study followed a phenomenological research design and included 7 focus group interviews with end users and 1 with stakeholders, held between July and December 2020. End users were recruited through various institutions in the Netherlands, for example, insurance companies and local governments. All focus groups were semistructured using interview guides and were held via videoconferencing due to the COVID-19 pandemic measures. Each participant received access to a health app platform where they were enabled to purchase reliable, preselected health apps with a budget of euro100 (US $107.35). The budget was valid for the entire research period. The health app platform offered 38 apps. A third party, a health care coalition, selected the apps to be included in FitKnip. The analyses were conducted according to the principles of the Framework Method.Results: A priori formulated themes were concept, acceptability, health empowerment, and outcomes, and the roles of stakeholders for the future implementation of a health app platform. Both end users (n=31) and stakeholders (n=5) were enthusiastic about the concept of a health app platform. End users indicated missing apps regarding physical health and lifestyle and needing more guidance toward suitable apps. End users saw health empowerment as a precondition to using a health app platform and achieving health outcomes depending on the purchased mobile apps. End users and stakeholders identified potential providers and financing parties of FitKnip. Stakeholders recommended the establishment of a reputable national or international quality guidelines or certification for health and wellbeing apps, that can demonstrate the quality and reliability of mobile health applications.Conclusions: This study showed the need for a personalized and flexible platform. Next to this, a deeper understanding of the roles of stakeholders in such initiatives is needed especially on financing and reimbursement of health promotion and digital health services. A personalized, flexible health app platform is a promising initiative to support individuals in their health. Show less
Willemsen, R.F.; Meijer, E.; Berg, L.N. van den; Burg, L. van der; Chavannes, N.H.; Aardoom, J.J. 2023
Background: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for... Show moreBackground: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for themselves. In the FitKnip experiment, individuals were given access to a health app platform, where they could purchase reliable preselected health apps with a personal budget of €100 (US $107.35). By conducting a prospective study, we aimed to scientifically evaluate the FitKnip experiment as an innovative way to improve population health.Objective: The aim of the experiment was to scientifically evaluate the FitKnip experiment as an innovative way to improve population health. More specifically, we conducted an in-depth qualitative evaluation of the concept and acceptability of FitKnip, its perceived impact on health empowerment, as well as the roles of stakeholders for the future implementation of a health app platform through focus group interviews.Methods: This study followed a phenomenological research design and included 7 focus group interviews with end users and 1 with stakeholders, held between July and December 2020. End users were recruited through various institutions in the Netherlands, for example, insurance companies and local governments. All focus groups were semistructured using interview guides and were held via videoconferencing due to the COVID-19 pandemic measures. Each participant received access to a health app platform where they were enabled to purchase reliable, preselected health apps with a budget of €100 (US $107.35). The budget was valid for the entire research period. The health app platform offered 38 apps. A third party, a health care coalition, selected the apps to be included in FitKnip. The analyses were conducted according to the principles of the Framework Method.Results: A priori formulated themes were concept, acceptability, health empowerment, and outcomes, and the roles of stakeholders for the future implementation of a health app platform. Both end users (n=31) and stakeholders (n=5) were enthusiastic about the concept of a health app platform. End users indicated missing apps regarding physical health and lifestyle and needing more guidance toward suitable apps. End users saw health empowerment as a precondition to using a health app platform and achieving health outcomes depending on the purchased mobile apps. End users and stakeholders identified potential providers and financing parties of FitKnip. Stakeholders recommended the establishment of a reputable national or international quality guidelines or certification for health and wellbeing apps, that can demonstrate the quality and reliability of mobile health applications.Conclusions: This study showed the need for a personalized and flexible platform. Next to this, a deeper understanding of the roles of stakeholders in such initiatives is needed especially on financing and reimbursement of health promotion and digital health services. A personalized, flexible health app platform is a promising initiative to support individuals in their health. Show less
Willemsen, R.F.; Meijer, E.; Berg, L.N. van den; Burg, L. van der; Chavannes, N.H.; Aardoom, J.J. 2023
Background: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for... Show moreBackground: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for themselves. In the FitKnip experiment, individuals were given access to a health app platform, where they could purchase reliable preselected health apps with a personal budget of euro100 (US $107.35). By conducting a prospective study, we aimed to scientifically evaluate the FitKnip experiment as an innovative way to improve population health.Objective: The aim of the experiment was to scientifically evaluate the FitKnip experiment as an innovative way to improve population health. More specifically, we conducted an in-depth qualitative evaluation of the concept and acceptability of FitKnip, its perceived impact on health empowerment, as well as the roles of stakeholders for the future implementation of a health app platform through focus group interviews.Methods: This study followed a phenomenological research design and included 7 focus group interviews with end users and 1 with stakeholders, held between July and December 2020. End users were recruited through various institutions in the Netherlands, for example, insurance companies and local governments. All focus groups were semistructured using interview guides and were held via videoconferencing due to the COVID-19 pandemic measures. Each participant received access to a health app platform where they were enabled to purchase reliable, preselected health apps with a budget of euro100 (US $107.35). The budget was valid for the entire research period. The health app platform offered 38 apps. A third party, a health care coalition, selected the apps to be included in FitKnip. The analyses were conducted according to the principles of the Framework Method.Results: A priori formulated themes were concept, acceptability, health empowerment, and outcomes, and the roles of stakeholders for the future implementation of a health app platform. Both end users (n=31) and stakeholders (n=5) were enthusiastic about the concept of a health app platform. End users indicated missing apps regarding physical health and lifestyle and needing more guidance toward suitable apps. End users saw health empowerment as a precondition to using a health app platform and achieving health outcomes depending on the purchased mobile apps. End users and stakeholders identified potential providers and financing parties of FitKnip. Stakeholders recommended the establishment of a reputable national or international quality guidelines or certification for health and wellbeing apps, that can demonstrate the quality and reliability of mobile health applications.Conclusions: This study showed the need for a personalized and flexible platform. Next to this, a deeper understanding of the roles of stakeholders in such initiatives is needed especially on financing and reimbursement of health promotion and digital health services. A personalized, flexible health app platform is a promising initiative to support individuals in their health. Show less
Willemsen, R.F.; Meijer, E.; Berg, L.N. van den; Burg, L. van der; Chavannes, N.H.; Aardoom, J.J. 2023
Background: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for... Show moreBackground: eHealth has the potential to improve health outcomes. However, this potential is largely untapped. Individuals face an overload of apps and have difficulties choosing suitable apps for themselves. In the FitKnip experiment, individuals were given access to a health app platform, where they could purchase reliable preselected health apps with a personal budget of €100 (US $107.35). By conducting a prospective study, we aimed to scientifically evaluate the FitKnip experiment as an innovative way to improve population health.Objective: The aim of the experiment was to scientifically evaluate the FitKnip experiment as an innovative way to improve population health. More specifically, we conducted an in-depth qualitative evaluation of the concept and acceptability of FitKnip, its perceived impact on health empowerment, as well as the roles of stakeholders for the future implementation of a health app platform through focus group interviews.Methods: This study followed a phenomenological research design and included 7 focus group interviews with end users and 1 with stakeholders, held between July and December 2020. End users were recruited through various institutions in the Netherlands, for example, insurance companies and local governments. All focus groups were semistructured using interview guides and were held via videoconferencing due to the COVID-19 pandemic measures. Each participant received access to a health app platform where they were enabled to purchase reliable, preselected health apps with a budget of €100 (US $107.35). The budget was valid for the entire research period. The health app platform offered 38 apps. A third party, a health care coalition, selected the apps to be included in FitKnip. The analyses were conducted according to the principles of the Framework Method.Results: A priori formulated themes were concept, acceptability, health empowerment, and outcomes, and the roles of stakeholders for the future implementation of a health app platform. Both end users (n=31) and stakeholders (n=5) were enthusiastic about the concept of a health app platform. End users indicated missing apps regarding physical health and lifestyle and needing more guidance toward suitable apps. End users saw health empowerment as a precondition to using a health app platform and achieving health outcomes depending on the purchased mobile apps. End users and stakeholders identified potential providers and financing parties of FitKnip. Stakeholders recommended the establishment of a reputable national or international quality guidelines or certification for health and wellbeing apps, that can demonstrate the quality and reliability of mobile health applications.Conclusions: This study showed the need for a personalized and flexible platform. Next to this, a deeper understanding of the roles of stakeholders in such initiatives is needed especially on financing and reimbursement of health promotion and digital health services. A personalized, flexible health app platform is a promising initiative to support individuals in their health. Show less
Background: Facioscapulohumeral muscular dystrophy (FSHD) is a progressive neuromuscular disease. Its slow and variable progression makes the development of new treatments highly dependent on... Show moreBackground: Facioscapulohumeral muscular dystrophy (FSHD) is a progressive neuromuscular disease. Its slow and variable progression makes the development of new treatments highly dependent on validated biomarkers that can quantify disease progression and response to drug interventions.Objective: We aimed to build a tool that estimates FSHD clinical severity based on behavioral features captured using smartphone and remote sensor data. The adoption of remote monitoring tools, such as smartphones and wearables, would provide a novel opportunity for continuous, passive, and objective monitoring of FSHD symptom severity outside the clinic.Methods: In total, 38 genetically confirmed patients with FSHD were enrolled. The FSHD Clinical Score and the Timed Up and Go (TUG) test were used to assess FSHD symptom severity at days 0 and 42. Remote sensor data were collected using an Android smartphone, Withings Steel HR+, Body+, and BPM Connect+ for 6 continuous weeks. We created 2 single-task regression models that estimated the FSHD Clinical Score and TUG separately. Further, we built 1 multitask regression model that estimated the 2 clinical assessments simultaneously. Further, we assessed how an increasingly incremental time window affected the model performance. To do so, we trained the models on an incrementally increasing time window (from day 1 until day 14) and evaluated the predictions of the clinical severity on the remaining 4 weeks of data.Results: The single-task regression models achieved an R2 of 0.57 and 0.59 and a root-mean-square error (RMSE) of 2.09 and 1.66 when estimating FSHD Clinical Score and TUG, respectively. Time spent at a health-related location (such as a gym or hospital) and call duration were features that were predictive of both clinical assessments. The multitask model achieved an R2 of 0.66 and 0.81 and an RMSE of 1.97 and 1.61 for the FSHD Clinical Score and TUG, respectively, and therefore outperformed the single-task models in estimating clinical severity. The 3 most important features selected by the multitask model were light sleep duration, total steps per day, and mean steps per minute. Using an increasing time window (starting from day 1 to day 14) for the FSHD Clinical Score, TUG, and multitask estimation yielded an average R2 of 0.65, 0.79, and 0.76 and an average RMSE of 3.37, 2.05, and 4.37, respectively. Conclusions: We demonstrated that smartphone and remote sensor data could be used to estimate FSHD clinical severity and therefore complement the assessment of FSHD outside the clinic. In addition, our results illustrated that training the models on the first week of data allows for consistent and stable prediction of FSHD symptom severity. Longitudinal follow-up studies should be conducted to further validate the reliability and validity of the multitask model as a tool to monitor disease progression over a longer period. Show less
Background: Digital technologies have the potential to provide objective and precise tools to detect depression-related symptoms. Deployment of digital technologies in clinical research can enable... Show moreBackground: Digital technologies have the potential to provide objective and precise tools to detect depression-related symptoms. Deployment of digital technologies in clinical research can enable collection of large volumes of clinically relevant data that may not be captured using conventional psychometric questionnaires and patient-reported outcomes. Rigorous methodology studies to develop novel digital endpoints in depression are warranted.Objective: We conducted an exploratory, cross-sectional study to evaluate several digital technologies in subjects with major depressive disorder (MDD) and persistent depressive disorder (PDD), and healthy controls. The study aimed at assessing utility and accuracy of the digital technologies as potential diagnostic tools for unipolar depression, as well as correlating digital biomarkers to clinically validated psychometric questionnaires in depression.Methods: A cross-sectional, non-interventional study of 20 participants with unipolar depression (MDD and PDD/dysthymia) and 20 healthy controls was conducted at the Centre for Human Drug Research (CHDR), the Netherlands. Eligible participants attended three in-clinic visits (days 1, 7, and 14), at which they underwent a series of assessments, including conventional clinical psychometric questionnaires and digital technologies. Between the visits, there was at-home collection of data through mobile applications. In all, seven digital technologies were evaluated in this study. Three technologies were administered via mobile applications: an interactive tool for the self-assessment of mood, and a cognitive test; a passive behavioral monitor to assess social interactions and global mobility; and a platform to perform voice recordings and obtain vocal biomarkers. Four technologies were evaluated in the clinic: a neuropsychological test battery; an eye motor tracking system; a standard high-density electroencephalogram (EEG)-based technology to analyze the brain network activity during cognitive testing; and a task quantifying bias in emotion perception.Results: Our data analysis was organized by technology - to better understand individual features of various technologies. In many cases, we obtained simple, parsimonious models that have reasonably high diagnostic accuracy and potential to predict standard clinical outcome in depression.Conclusion: This study generated many useful insights for future methodology studies of digital technologies and proof-of-concept clinical trials in depression and possibly other indications. Show less
Background: Mobile health can be used to generate innovative insights into optimizing treatment to improve allergic rhinitis (AR) control.Objectives: A cross-sectional real-world observational... Show moreBackground: Mobile health can be used to generate innovative insights into optimizing treatment to improve allergic rhinitis (AR) control.Objectives: A cross-sectional real-world observational study was undertaken in 22 countries to complement a pilot study and provide novel information on medication use, disease control, and work productivity in the everyday life of patients with AR.Methods: A mobile phone app (Allergy Diary, which is freely available on Google Play and Apple stores) was used to collect the data of daily visual analogue scale (VAS) scores for (1) overall allergic symptoms; (2) nasal, ocular, and asthma symptoms; (3) work; and (4) medication use by using a treatment scroll list including all allergy medications (prescribed and over-the-counter) customized for 22 countries. The 4 most common intranasal medications containing intranasal corticosteroids and 8 oral H-1-antihistamines were studied.Results: Nine thousand one hundred twenty-two users filled in 112,054 days of VASs in 2016 and 2017. Assessment of days was informative. Control of days with rhinitis differed between no (best control), single (good control for intranasal corticosteroid-treated days), or multiple (worst control) treatments. Users with the worst control increased the range of treatments being used. The same trend was found for asthma, eye symptoms, and work productivity. Differences between oral H-1-antihistamines were found.Conclusions: This study confirms the usefulness of the Allergy Diary in accessing and assessing behavior in patients with AR. This observational study using a very simple assessment tool (VAS) on a mobile phone had the potential to answer questions previously thought infeasible. Show less
Bruining, N.; Caiani, E.; Chronaki, C.; Guzik, P.; Velde, E. van der 2014
