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Background: The rapid proliferation of medical apps has transformed the health care landscape by giving patients and health care providers unprecedented access to personalized health information and services. However, concerns regarding the effectiveness and safety of medical apps have raised questions regarding the efficacy of randomized controlled trials (RCTs) in the evaluation of such apps and as a requirement for their regulation as mobile medical devices., Objective: This study aims to address this issue by investigating alternative methods, apart from RCTs, for evaluating and regulating medical apps., Methods: Using a qualitative approach, a focus group study with 46 international and multidisciplinary public health experts was conducted at the 17th World Congress on Public Health in May 2023 in Rome, Italy. The group was split into 3 subgroups to gather in-depth insights into alternative approaches for evaluating and regulating medical apps. We conducted a policy analysis on the current regulation of medical apps as mobile medical devices for the 4 most represented countries in the workshop: Italy, Germany, Canada, and Australia. We developed a logic model that combines the evaluation and regulation domains on the basis of these findings., Results: The focus group discussions explored the strengths and limitations of the current evaluation and regulation methods and identified potential alternatives that could enhance the quality and safety of medical apps. Although RCTs were only explicitly mentioned in the German regulatory system as one of many options, an analysis of chosen evaluation methods for German apps on prescription pointed toward a "scientific reflex" where RCTs are always the chosen evaluation method. However, this method has substantial limitations when used to evaluate digital interventions such as medical apps. Comparable results were observed during the focus group discussions, where participants expressed similar experiences with their own evaluation approaches. In addition, the participants highlighted numerous alternatives to RCTs. These alternatives can be used at different points during the life cycle of a digital intervention to assess its efficacy and potential harm to users., Conclusions: It is crucial to recognize that unlike analog tools, digital interventions constantly evolve, posing challenges to inflexible evaluation methods such as RCTs. Potential risks include high dropout rates, decreased adherence, and nonsignificant results. However, existing regulations do not explicitly advocate for other evaluation methodologies. Our research highlighted the necessity of overcoming the gap between regulatory demands to demonstrate safety and efficacy of medical apps and evolving scientific practices, ensuring that digital health innovation is evaluated and regulated in a way that considers the unique characteristics of mobile medical devices., (©Laura Maaß, Robert Hrynyschyn, Martin Lange, Alexandra Löwe, Kathrin Burdenski, Kaley Butten, Sebastian Vorberg, Mariam Hachem, Aldo Gorga, Vittorio Grieco, Vincenzo Restivo, Giuseppe Vella, Marlien Varnfield, Felix Holl. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 30.09.2024.)

Background: Currently, there is a need to optimize knowledge on digital transformation in mental health care, including digital therapeutics (eg, prescription apps), in medical education. However, in Germany, digital health has not yet been systematically integrated into medical curricula and is taught in a relatively small number of electives. Challenges for lecturers include the dynamic field as well as lacking guidance on how to efficiently apply innovative teaching formats for these new digital competencies. Quality improvement projects provide options to pilot-test novel educational offerings, as little is known about the acceptability of participatory approaches in conventional medical education., Objective: This quality improvement project addressed the gap in medical school electives on digital health literacy by introducing and evaluating an elective scoping study on the systematic development of different health app concepts designed by students to cultivate essential skills for future health care professionals (ie, mobile health [mHealth] competencies)., Methods: This proof-of-concept study describes the development, optimization, implementation, and evaluation of a web-based elective on digital (mental) health competencies in medical education. Implemented as part of a quality improvement project, the elective aimed to guide medical students in developing app concepts applying a design thinking approach at a German medical school from January 2021 to January 2024. Topics included defining digital (mental) health, quality criteria for health apps, user perspective, persuasive design, and critical reflection on digitization in medical practice. The elective was offered 6 times within 36 months, with continuous evaluation and iterative optimization using both process and outcome measures, such as web-based questionnaires. We present examples of app concepts designed by students and summarize the quantitative and qualitative evaluation results., Results: In total, 60 students completed the elective and developed 25 health app concepts, most commonly targeting stress management and depression. In addition, disease management and prevention apps were designed for various somatic conditions such as diabetes and chronic pain. The results indicated high overall satisfaction across the 6 courses according to the evaluation questionnaire, with lower scores indicating higher satisfaction on a scale ranging from 1 to 6 (mean 1.70, SD 0.68). Students particularly valued the content, flexibility, support, and structure. While improvements in group work, submissions, and information transfer were suggested, the results underscore the usefulness of the web-based elective., Conclusions: This quality improvement project provides insights into relevant features for the successful user-centered and creative integration of mHealth competencies into medical education. Key factors for the satisfaction of students involved the participatory mindset, focus on competencies, discussions with app providers, and flexibility. Future efforts should define important learning objectives for digital health literacy and provide recommendations for integration rather than debating the need for digital health integration., (©Fatma Sahan, Lisa Guthardt, Karin Panitz, Anna Siegel-Kianer, Isabel Eichhof, Björn D Schmitt, Jennifer Apolinario-Hagen. Originally published in JMIR Medical Education (https://mededu.jmir.org), 20.09.2024.)

Background: Specialized studies have shown that smartphone-based social interaction data are predictors of depressive and anxiety symptoms. Moreover, at times during the COVID-19 pandemic, social interaction took place primarily remotely. To appropriately test these objective data for their added value for epidemiological research during the pandemic, it is necessary to include established predictors., Objective: Using a comprehensive model, we investigated the extent to which smartphone-based social interaction data contribute to the prediction of depressive and anxiety symptoms, while also taking into account well-established predictors and relevant pandemic-specific factors., Methods: We developed the Corona Health App and obtained participation from 490 Android smartphone users who agreed to allow us to collect smartphone-based social interaction data between July 2020 and February 2021. Using a cross-sectional design, we automatically collected data concerning average app use in terms of the categories video calls and telephony, messenger use, social media use, and SMS text messaging use, as well as pandemic-specific predictors and sociodemographic covariates. We statistically predicted depressive and anxiety symptoms using elastic net regression. To exclude overfitting, we used 10-fold cross-validation., Results: The amount of variance explained (R 2 ) was 0.61 for the prediction of depressive symptoms and 0.57 for the prediction of anxiety symptoms. Of the smartphone-based social interaction data included, only messenger use proved to be a significant negative predictor of depressive and anxiety symptoms. Video calls were negative predictors only for depressive symptoms, and SMS text messaging use was a negative predictor only for anxiety symptoms., Conclusions: The results show the relevance of smartphone-based social interaction data in predicting depressive and anxiety symptoms. However, even taken together in the context of a comprehensive model with well-established predictors, the data only add a small amount of value., (©Johanna-Sophie Edler, Yannik Terhorst, Rüdiger Pryss, Harald Baumeister, Caroline Cohrdes. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 16.09.2024.)

Background: Although several digital health interventions (DHIs) have shown promise in the care of skin diseases their uptake in Germany has been limited. To fully understand the reasons for the low uptake, an in-depth analysis of patients' and health care providers' barriers and facilitators in dermatology is needed., Objective: The objective of this study was to explore and compare attitudes, acceptability, barriers, and facilitators of patients, dermatologists, and nurses toward DHIs in dermatology., Methods: We conducted 6 web-based focus groups each with patients (n=34), dermatologists (n=30), and nurses (n=30) using a semistructured interview guide with short descriptions of DHIs described in the literature. A content analysis was performed using deductive constructs, following the unified theory of acceptance and use of technology framework, and inductive categories., Results: Patients identified many positive performance expectancies, such as reduced travel times and improvement in follow-up appointments. Dermatologists also stated positive effects (eg, promotion of standardized care), but also negative implications of health care digitalization (eg, increased workload). All stakeholders reported that a DHI should bring additional value to all stakeholders. A lack of digital competence among patients was identified as the major barrier to adoption by all 3 groups. Nurses and dermatologists want apps that are easy to use and easy to implement into their daily routines. Trust in selected institutions, colleagues, and physicians was identified as a facilitator. Patients reported their dependence on the dermatologists' acceptance. All groups expressed concerns about data privacy risks and dermatologists stated insecurities toward data privacy laws., Conclusions: To ensure successful digitalization in dermatology, apps should be user-friendly, adapted to users' skill levels, and beneficial for all stakeholders. The incorporation of dermatologists' perspectives is especially important as their acceptance may impact use among patients and nurses. DHIs should ensure and be transparent about data privacy. The found barriers and facilitators can be used for implementation strategies., (©Patrick Reinders, Matthias Augustin, Anastasia Fleyder, Marina Otten. Originally published in JMIR Dermatology (http://derma.jmir.org), 03.09.2024.)

Background: Patient-reported outcomes are relevant in clinical practice showing patient benefits, supporting clinicians' decision-making, and contributing to the delivery of high standards of care. Digital monitoring of patient-reported outcomes is still rare. The Patient Benefit Index (PBI) measures benefits and goals from patients' views and may be relevant for regular documentation and shared decision-making., Objective: This study aimed to develop electronic versions of the PBI to examine their feasibility and acceptability in clinical practice for patients with psoriasis., Methods: We developed an app and a web version of the existing, valid PBI using focus groups and cognitive debriefings with patients before conducting a quantitative survey on its feasibility and acceptability. Conduction took part in an outpatient dermatology care unit in Germany. Descriptive and subgroup analyses were conducted., Results: A total of 139 patients completed the electronic PBIs (ePBIs) and took part in the survey. The ePBI was understandable (n=129-137, 92.8%-98.6%) and feasible, for example, easy to read (n=135, 97.1%) and simple to handle (n=137, 98.5%). Acceptability was also high, for example, patients can imagine using and discussing the ePBI data in practice (n=91, 65.5%) and documenting it regularly (n=88, 63.3%). They believe it could support treatment decisions (n=118, 84.9%) and improve communication with their physician (n=112, 81.3%). They can imagine filling in electronic questionnaires regularly (n=118, 84.9%), even preferring electronic over paper versions (n=113, 81.2%). Older and less educated people show less feasibility, but the latter expected the relationship with their physician to improve and would be more willing to invest time or effort., Conclusions: The app and web version of the PBI are usable and acceptable for patients offering comprehensive documentation and patient participation in practice. An implementation strategy should consider patients' needs, barriers, and facilitators but also physicians' attitudes and requirements from the health care system., (©Marina Otten, Vahid Djamei, Matthias Augustin. Originally published in JMIR Dermatology (http://derma.jmir.org), 09.08.2024.)

Background: Early weight loss is an established predictor for treatment outcomes in weight management interventions for people with obesity. However, there is a paucity of additional, reliable, and clinically actionable early predictors in weight management interventions. Novel blended-care weight management interventions combine coach and app support and afford new means of structured, continuous data collection, informing research on treatment adherence and outcome prediction., Objective: Against this backdrop, this study analyzes app engagement as a predictor for weight loss in large-scale, real-world, blended-care interventions. We hypothesize that patients who engage more frequently in app usage in blended-care treatment (eg, higher logging activity) lose more weight than patients who engage comparably less frequently at 3 and 6 months of intervention., Methods: Real-world data from 19,211 patients in obesity treatment were analyzed retrospectively. Patients were treated with 3 different blended-care weight management interventions, offered in Switzerland, the United Kingdom, and Germany by a digital behavior change provider. The principal component analysis identified an overarching metric for app engagement based on app usage. A median split informed a distinction in higher and lower engagers among the patients. Both groups were matched through optimal propensity score matching for relevant characteristics (eg, gender, age, and start weight). A linear regression model, combining patient characteristics and app-derived data, was applied to identify predictors for weight loss outcomes., Results: For the entire sample (N=19,211), mean weight loss was -3.24% (SD 4.58%) at 3 months and -5.22% (SD 6.29%) at 6 months. Across countries, higher app engagement yielded more weight loss than lower engagement after 3 but not after 6 months of intervention (P 3 months <.001 and P 6 months =.59). Early app engagement within the first 3 months predicted percentage weight loss in Switzerland and Germany, but not in the United Kingdom (P Switzerland <.001, P United Kingdom =.12, and P Germany =.005). Higher age was associated with stronger weight loss in the 3-month period (P Switzerland =.001, P United Kingdom =.002, and P Germany <.001) and, for Germany, also in the 6-month period (P Switzerland =.09, P United Kingdom =.46, and P Germany =.03). In Switzerland, higher numbers of patients' messages to coaches were associated with higher weight loss (P 3 months <.001 and P 6 months <.001). Messages from coaches were not significantly associated with weight loss (all P>.05)., Conclusions: Early app engagement is a predictor of weight loss, with higher engagement yielding more weight loss than lower engagement in this analysis. This new predictor lends itself to automated monitoring and as a digital indicator for needed or adapted clinical action. Further research needs to establish the reliability of early app engagement as a predictor for treatment adherence and outcomes. In general, the obtained results testify to the potential of app-derived data to inform clinical monitoring practices and intervention design., (©Marco Lehmann, Lucy Jones, Felix Schirmann. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 07.06.2024.)

Background: Distress is highly prevalent among patients with cancer, but supportive care needs often go unmet. Digital therapeutics hold the potential to overcome barriers in cancer care and improve health outcomes., Objective: This study conducted a randomized controlled trial to investigate the efficacy of Mika, an app-based digital therapeutic designed to reduce distress across the cancer trajectory., Methods: This nationwide waitlist randomized controlled trial in Germany enrolled patients with cancer across all tumor entities diagnosed within the last 5 years. Participants were randomized into the intervention (Mika plus usual care) and control (usual care alone) groups. The participants completed web-based assessments at baseline and at 2, 6, and 12 weeks. The primary outcome was the change in distress from baseline to week 12, as measured by the National Comprehensive Cancer Network Distress Thermometer. Secondary outcomes included depression, anxiety (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and quality of life (Clinical Global Impression-Improvement Scale). Intention-to-treat and per-protocol analyses were performed. Analyses of covariance were used to test for outcome changes over time between the groups, controlling for baseline., Results: A total of 218 patients (intervention: n=99 and control: n=119) were included in the intention-to-treat analysis. Compared with the control group, the intervention group reported greater reductions in distress (P=.03; ηp²=0.02), depression (P<.001; ηp²=0.07), anxiety (P=.03; ηp²=0.02), and fatigue (P=.04; ηp²=0.02). Per-protocol analyses revealed more pronounced treatment effects, with the exception of fatigue. No group difference was found for quality of life., Conclusions: Mika effectively diminished distress in patients with cancer. As a digital therapeutic solution, Mika offers accessible, tailored psychosocial and self-management support to address the unmet needs in cancer care., Trial Registration: German Clinical Trials Register (DRKS) DRKS00026038; https://drks.de/search/en/trial/DRKS00026038., (©Franziska Springer, Ayline Maier, Michael Friedrich, Jan Simon Raue, Gandolf Finke, Florian Lordick, Guy Montgomery, Peter Esser, Hannah Brock, Anja Mehnert-Theuerkauf. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 25.04.2024.)

Background: Since fall 2020, mobile health (mHealth) apps have become an integral part of the German health care system. The belief that mHealth apps have the potential to make the health care system more efficient, close gaps in care, and improve the economic outcomes related to health is unwavering and already partially confirmed. Nevertheless, problems and barriers in the context of mHealth apps usually remain unconsidered., Objective: The focus groups and interviews conducted in this study aim to shed light on problems and barriers in the context of mHealth apps from the perspective of patients., Methods: Guided focus groups and individual interviews were conducted with patients with a disease for which an approved mHealth app was available at the time of the interviews. Participants were recruited via self-help groups. The interviews were recorded, transcribed, and subjected to a qualitative content analysis. The content analysis was based on 10 problem categories ("validity," "usability," "technology," "use and adherence," "data privacy and security," "patient-physician relationship," "knowledge and skills," "individuality," "implementation," and "costs") identified in a previously conducted scoping review. Participants were asked to fill out an additional questionnaire about their sociodemographic data and about their use of technology., Results: A total of 38 patients were interviewed in 5 focus groups (3 onsite and 2 web-based) and 5 individual web-based interviews. The additional questionnaire was completed by 32 of the participants. Patients presented with a variety of different diseases, such as arthrosis, tinnitus, depression, or lung cancer. Overall, 16% (5/32) of the participants had already been prescribed an app. During the interviews, all 10 problem categories were discussed and considered important by patients. A myriad of problem manifestations could be identified for each category. This study shows that there are relevant problems and barriers in the context of mHealth apps from the perspective of patients, which warrant further attention., Conclusions: There are essentially 3 different areas of problems in the context of mHealth apps that could be addressed to improve care: quality of the respective mHealth app, its integration into health care, and the expandable digital literacy of patients., (©Godwin Denk Giebel, Carina Abels, Felix Plescher, Christian Speckemeier, Nils Frederik Schrader, Kirstin Börchers, Jürgen Wasem, Silke Neusser, Nikola Blase. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 23.04.2024.)

Background: The use of eHealth technology in cardiac rehabilitation (CR) is a promising approach to enhance patient outcomes since adherence to healthy lifestyles and risk factor management during phase III CR maintenance is often poorly supported. However, patients' needs and expectations have not been extensively analyzed to inform the design of such eHealth solutions., Objective: The goal of this study was to provide a detailed patient perspective on the most important functionalities to include in an eHealth solution to assist them in phase III CR maintenance., Methods: A guided survey as part of a Living Lab approach was conducted in Germany (n=49) and Spain (n=30) involving women (16/79, 20%) and men (63/79, 80%) with coronary artery disease (mean age 57 years, SD 9 years) participating in a structured center-based CR program. The survey covered patients' perceived importance of different CR components in general, current usage of technology/technical devices, and helpfulness of the potential features of eHealth in CR. Questionnaires were used to identify personality traits (psychological flexibility, optimism/pessimism, positive/negative affect), potentially predisposing patients to acceptance of an app/monitoring devices., Results: All the patients in this study owned a smartphone, while 30%-40% used smartwatches and fitness trackers. Patients expressed the need for an eHealth platform that is user-friendly, personalized, and easily accessible, and 71% (56/79) of the patients believed that technology could help them to maintain health goals after CR. Among the offered components, support for regular physical exercise, including updated schedules and progress documentation, was rated the highest. In addition, patients rated the availability of information on diagnosis, current medication, test results, and risk scores as (very) useful. Of note, for each item, except smoking cessation, 35%-50% of the patients indicated a high need for support to achieve their long-term health goals, suggesting the need for individualized care. No major differences were detected between Spanish and German patients (all P>.05) and only younger age (P=.03) but not sex, education level, or personality traits (all P>.05) were associated with the acceptance of eHealth components., Conclusions: The patient perspectives collected in this study indicate high acceptance of personalized user-friendly eHealth platforms with remote monitoring to improve adherence to healthy lifestyles among patients with coronary artery disease during phase III CR maintenance. The identified patient needs comprise support in physical exercise, including regular updates on personalized training recommendations. Availability of diagnoses, laboratory results, and medications, as part of a mobile electronic health record were also rated as very useful., Trial Registration: ClinicalTrials.gov NCT05461729; https://clinicaltrials.gov/study/NCT05461729., (©Boris Schmitz, Svenja Wirtz, Manuela Sestayo-Fernández, Hendrik Schäfer, Emma R Douma, Marta Alonso Vazquez, Violeta González-Salvado, Mirela Habibovic, Dimitris Gatsios, Willem Johan Kop, Carlos Peña-Gil, Frank Mooren. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 22.02.2024.)

Background: Smartphone apps, including those for digital contact tracing (DCT), played a crucial role in containing infections during the COVID-19 pandemic. Their primary function is to generate and disseminate information to disrupt transmissions based on various events, such as encounters, vaccinations, locations, or infections. Although the functionality of these apps has been extensively studied, there is still a lack of qualitative research addressing critical issues., Objective: We will demonstrate that the use of DCT presents a challenge due to the tension between continuous health monitoring and uncertainties related to transparency and user sovereignty. On one hand, DCT enables the monitoring of various risk factors, including data-based calculations of infection probabilities. On the other hand, continuous risk management is intertwined with several uncertainties, including the unclear storage of personal data, who has access to it, and how it will be used in the future., Methods: We focus on the German "Corona-Warn-App" and support our argument with empirical data from 19 expert interviews conducted between 2020 and 2021. The interviews were conducted using a semistructured questionnaire and analyzed according to the principles of grounded theory., Results: Our data underscores 3 dimensions: transparency, data sovereignty, and the east-west divide. While transparency is considered an essential foundation for establishing trust in the use of DCT by providing a sense of security, data sovereignty is seen as a high value during the pandemic, protecting users from an undesired loss of control. The aspect of the east-west divide highlights the idea of incorporating sociocultural values and standards into technology, emphasizing that algorithms and data-driven elements, such as distance indicators, encounters, and isolations, are also influenced by sociocultural factors., Conclusions: The effective use of DCT for pandemic containment relies on achieving a balance between individual control and technological prevention. Maximizing the technological benefits of these tools is crucial. However, users must also be mindful of the information they share and maintain control over their shared data., (©Dennis Krämer, Elisabeth Brachem, Lydia Schneider-Reuter, Isabella D'Angelo, Jochen Vollmann, Joschka Haltaufderheide. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 20.10.2023.)

Background: Digital contact tracing algorithms (DCTAs) have emerged as a means of supporting pandemic containment strategies and protecting populations from the adverse effects of COVID-19. However, the impact of DCTAs on users' privacy and autonomy has been heavily debated. Although privacy is often viewed as the ability to control access to information, recent approaches consider it as a norm that structures social life. In this regard, cultural factors are crucial in evaluating the appropriateness of information flows in DCTAs. Hence, an important part of ethical evaluations of DCTAs is to develop an understanding of their information flow and their contextual situatedness to be able to adequately evaluate questions about privacy. However, only limited studies and conceptual approaches are currently available in this regard., Objective: This study aimed to develop a case study methodology to include contextual cultural factors in ethical analysis and present exemplary results of a subsequent analysis of 2 different DCTAs following this approach., Methods: We conducted a comparative qualitative case study of the algorithm of the Google Apple Exposure Notification Framework as exemplified in the German Corona Warn App and the Japanese approach of Computation of Infection Risk via Confidential Locational Entries (CIRCLE) method. The methodology was based on a postphenomenological perspective, combined with empirical investigations of the technological artifacts within their context of use. An ethics of disclosure approach was used to focus on the social ontologies created by the algorithms and highlight their connection to the question about privacy., Results: Both algorithms use the idea of representing a social encounter of 2 subjects. These subjects gain significance in terms of risk against the background of a representation of their temporal and spatial properties. However, the comparative analysis reveals 2 major differences. Google Apple Exposure Notification Framework prioritizes temporality over spatiality. In contrast, the representation of spatiality is reduced to distance without any direction or orientation. However, the CIRCLE framework prioritizes spatiality over temporality. These different concepts and prioritizations can be seen to align with important cultural differences in considering basic concepts such as subject, time, and space in Eastern and Western thought., Conclusions: The differences noted in this study essentially lead to 2 different ethical questions about privacy that are raised against the respective backgrounds. These findings have important implications for the ethical evaluation of DCTAs, suggesting that a culture-sensitive assessment is required to ensure that technologies fit into their context and create less concern regarding their ethical acceptability. Methodologically, our study provides a basis for an intercultural approach to the ethics of disclosure, allowing for cross-cultural dialogue that can overcome mutual implicit biases and blind spots based on cultural differences., (©Joschka Haltaufderheide, Davide Viero, Dennis Krämer. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 28.06.2023.)

Background: The digitization of health care led to a steady increase in the adoption and use of mobile health (mHealth) apps. Germany is the first country in the world to cover the costs of mHealth apps through statutory health insurance. Although the benefits of mHealth apps are discussed in detail, aspects of problems and barriers are rarely studied., Objective: This scoping review aimed to map and categorize the evidence on problems and barriers related to the use of mHealth apps., Methods: Systematic searches were conducted in the MEDLINE, Embase, and PsycINFO databases. Additional searches were conducted on JMIR Publications and on websites of relevant international organizations. The inclusion criteria were publications dealing with apps similar to those approved in the German health care system, publications addressing problems and barriers related to the use of mHealth apps, and articles published between January 1, 2015, and June 8, 2021. Study selection was performed by 2 reviewers. The manuscript was drafted according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The analysis of the included publications and categorization of problems and hurdles were performed using MAXQDA (VERBI Software GmbH)., Results: The database search identified 1479 publications. Of the 1479 publications, 21 (1.42%) met the inclusion criteria. A further 8 publications were included from citation searching and searching in JMIR Publications. The identified publications were analyzed for problems and barriers. Problems and barriers were classified into 10 categories ("validity," "usability," "technology," "use and adherence," "data privacy and security," "patient-physician relationship," "knowledge and skills," "individuality," "implementation," and "costs"). The most frequently mentioned categories were use and adherence (eg, incorporating the app into daily life or dropouts from use; n=22) and usability (eg, ease of use and design; n=19)., Conclusions: The search identified various problems and barriers in the context of mHealth apps. Although problems at the app level (such as usability) are studied frequently, problems at the system level are addressed rather vaguely. To ensure optimal use of and care with mHealth apps, it is essential to consider all types of problems and barriers. Therefore, researchers and policy makers should have a special focus on this issue to identify the needs for quality assurance., International Registered Report Identifier (irrid): RR2-10.2196/32702., (©Godwin Denk Giebel, Christian Speckemeier, Carina Abels, Felix Plescher, Kirstin Börchers, Jürgen Wasem, Nikola Blase, Silke Neusser. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 12.05.2023.)

Background: Telemedicine can help mitigate important health care challenges, such as demographic changes and the current COVID-19 pandemic, in high-income countries such as Germany. It gives physicians and patients the opportunity to interact via video consultations, regardless of their location, thus offering cost and time savings for both sides., Objective: We aimed to investigate whether telemedicine can be implemented efficiently in the follow-up care for patients in orthopedic and trauma surgery, with respect to patient satisfaction, physician satisfaction, and quality of care., Methods: We conducted a prospective randomized controlled trial in a German university hospital and enrolled 60 patients with different knee and shoulder conditions. For follow-up appointments, patients received either an in-person consultation in the clinic (control group) or a video consultation with their physician (telemedicine group). Patients' and physicians' subsequent evaluations of these follow-up appointments were collected and assessed using separate questionnaires., Results: On the basis of data from 52 consultations after 8 withdrawals, it was found that patients were slightly more satisfied with video consultations (mean 1.58, SD 0.643) than with in-clinic consultations (mean 1.64, SD 0.569), although the difference was not statistically significant (P=.69). After excluding video consultations marred by technical problems, no significant difference was found in physician satisfaction between the groups (mean 1.47, SD 0.516 vs mean 1.32, SD 0.557; P=.31). Further analysis indicated that telemedicine can be applied to broader groups of patients and that patients who have prior experience with telemedicine are more willing to use telemedicine for follow-up care., Conclusions: Telemedicine can be an alternative and efficient form of follow-up care for patients in orthopedic and trauma surgery in Germany, and it has no significant disadvantages compared with in-person consultations in the clinic., Trial Registration: German Clinical Trials Register DRKS00023445; https://www.drks.de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00023445., (©Jennifer Muschol, Martin Heinrich, Christian Heiss, Gero Knapp, Holger Repp, Henning Schneider, Ulrich Thormann, Johanna Uhlar, Kai Unzeitig, Christian Gissel. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 27.07.2022.)

Background: Health self-tracking is an evidence-based approach to optimize health and well-being for personal self-improvement through lifestyle changes. At the same time, user-generated health-related data can be of particular value for (health care) research. As longitudinal data, these data can provide evidence for developing better and new medications, diagnosing rare diseases faster, or treating chronic diseases., Objective: This quantitative study aims to investigate the impact of digital forced-choice nudges on the willingness of German health self-trackers to donate self-tracked health-related data for research. This study contributes to the body of knowledge on the effectiveness of nonmonetary incentives. Our study enables a gender-specific statement on influencing factors on the voluntary donation of personal health data and, at the same time, on the effectiveness of digital forced-choice nudges within tracking apps., Methods: We implemented a digital experiment using a web-based questionnaire by graphical manipulation of the Runtastic tracking app interface. We asked 5 groups independently to indicate their willingness to donate tracked data for research. We used a digital forced-choice nudge via a pop-up window, which framed the data donation request with 4 different counter values. We generated the counter values according to the specific target group needs identified from the research literature., Results: A sample of 919 was generated, of which, 625 (68%) were women and 294 (32%) were men. By dividing the sample into male and female participants, we take into account research on gender differences in privacy tendencies on the web and offline, showing that female participants display higher privacy concerns than male participants. A statistical group comparison shows that with a small effect size (r=0.21), men are significantly more likely (P=.04) to donate their self-tracked data for research if the need to take on social responsibility is addressed (the prosocial counter value in this case-contributing to society) compared with the control group without counter value. Selfish or pseudoprosocial counter values had no significant effect on willingness to donate health data among male or female health self-trackers in Germany when presented as a forced-choice nudge within a tracking app., Conclusions: Although surveys regularly reveal an 80% to 95% willingness to donate data on average in the population, our results show that only 41% (377/919) of the health self-trackers would donate their self-collected health data to research. Although selfish motives do not significantly influence willingness to donate, linking data donation to added societal value could significantly increase the likelihood of donating among male self-trackers by 15.5%. Thus, addressing the need to contribute to society promotes the willingness to donate data among male health self-trackers. The implementation of forced-choice framing nudges within tracking apps presented in a pop-up window can add to the accessibility of user-generated health-related data for research., (©Katharina Pilgrim, Sabine Bohnet-Joschko. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 21.02.2022.)

Background: Participatory epidemiology is an emerging field harnessing consumer data entries of symptoms. The free app Ada allows users to enter the symptoms they are experiencing and applies a probabilistic reasoning model to provide a list of possible causes for these symptoms., Objective: The objective of our study is to explore the potential contribution of Ada data to syndromic surveillance by comparing symptoms of influenza-like illness (ILI) entered by Ada users in Germany with data from a national population-based reporting system called GrippeWeb., Methods: We extracted data for all assessments performed by Ada users in Germany over 3 seasons (2017/18, 2018/19, and 2019/20) and identified those with ILI (report of fever with cough or sore throat). The weekly proportion of assessments in which ILI was reported was calculated (overall and stratified by age group), standardized for the German population, and compared with trends in ILI rates reported by GrippeWeb using time series graphs, scatterplots, and Pearson correlation coefficient., Results: In total, 2.1 million Ada assessments (for any symptoms) were included. Within seasons and across age groups, the Ada data broadly replicated trends in estimated weekly ILI rates when compared with GrippeWeb data (Pearson correlation-2017-18: r=0.86, 95% CI 0.76-0.92; P<.001; 2018-19: r=0.90, 95% CI 0.84-0.94; P<.001; 2019-20: r=0.64, 95% CI 0.44-0.78; P<.001). However, there were differences in the exact timing and nature of the epidemic curves between years., Conclusions: With careful interpretation, Ada data could contribute to identifying broad ILI trends in countries without existing population-based monitoring systems or to the syndromic surveillance of symptoms not covered by existing systems., (©Caoimhe Cawley, François Bergey, Alicia Mehl, Ashlee Finckh, Andreas Gilsdorf. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 04.11.2021.)

Background: Contact tracing apps are considered useful means to monitor SARS-CoV-2 infections during the off-peak stages of the COVID-19 pandemic. Their effectiveness is, however, dependent on the uptake of such COVID-19 apps., Objective: We examined the role of individuals' general health status in their willingness to use a COVID-19 tracing app as well as the roles of socioeconomic characteristics and COVID-19 proximity., Methods: We drew data from the WageIndicator Foundation Living and Working in Coronavirus Times survey. The survey collected data on labor market status as well as the potential confounders of the relationship between general health and COVID-19 tracing app usage, such as sociodemographics and regular smartphone usage data. The survey also contained information that allowed us to examine the role of COVID-19 proximity, such as whether an individual has contracted SARS-CoV-2, whether an individual has family members and colleagues with COVID-19, and whether an individual exhibits COVID-19 pandemic-induced depressive and anxiety symptoms. We selected data that were collected in Spain, Italy, Germany, and the Netherlands from individuals aged between 18 and 70 years (N=4504). Logistic regressions were used to measure individuals' willingness to use a COVID-19 tracing app., Results: We found that the influence that socioeconomic factors have on COVID-19 tracing app usage varied dramatically between the four countries, although individuals experiencing forms of not being employed (ie, recent job loss and inactivity) consistently had a lower willingness to use a contact tracing app (effect size: 24.6%) compared to that of employees (effect size: 33.4%; P<.001). Among the selected COVID-19 proximity indicators, having a close family member with SARS-CoV-2 infection was associated with higher contact tracing app usage (effect size: 36.3% vs 27.1%; P<.001). After accounting for these proximity factors and the country-based variations therein, we found that having a poorer general health status was significantly associated with a much higher likelihood of contact tracing app usage; compared to a self-reported "very good" health status (estimated probability of contact tracing app use: 29.6%), the "good" (estimated probability: +4.6%; 95% CI 1.2%-8.1%) and "fair or bad" (estimated probability: +6.3%; 95% CI 2.3%-10.3%) health statuses were associated with a markedly higher willingness to use a COVID-19 tracing app., Conclusions: Current public health policies aim to promote the use of smartphone-based contact tracing apps during the off-peak periods of the COVID-19 pandemic. Campaigns that emphasize the health benefits of COVID-19 tracing apps may contribute the most to the uptake of such apps. Public health campaigns that rely on digital platforms would also benefit from seriously considering the country-specific distribution of privacy concerns., (©Dirk Witteveen, Pablo de Pedraza. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 18.08.2021.)

Background: During the COVID-19 pandemic, one way to reduce further transmissions of SARS-CoV-2 is the widespread use of contact tracing apps. Such apps keep track of proximity contacts and warn contacts of persons who tested positive for an infection., Objective: In this study, we analyzed potential barriers to the large-scale adoption of the official contact tracing app that was introduced in Germany on June 16, 2020., Methods: Survey data were collected from 3276 adults during the week the app was introduced using an offline-recruited, probability-based online panel of the general adult population in Germany., Results: We estimate that 81% of the population aged 18 to 77 years possess the devices and ability to install the official app and that 35% are also willing to install and use it. Potential spreaders show high access to devices required to install the app (92%) and high ability to install the app (91%) but low willingness (31%) to correctly adopt the app, whereas for vulnerable groups, the main barrier is access (62%)., Conclusions: The findings suggest a pessimistic view on the effectiveness of app-based contact tracing to contain the COVID-19 pandemic. We recommend targeting information campaigns at groups with a high potential to spread the virus but who are unwilling to install and correctly use the app, in particular men and those aged between 30 and 59 years. In addition, vulnerable groups, in particular older individuals and those in lower-income households, may be provided with equipment and support to overcome their barriers to app adoption., (©Annelies G Blom, Alexander Wenz, Carina Cornesse, Tobias Rettig, Marina Fikel, Sabine Friedel, Katja Möhring, Elias Naumann, Maximiliane Reifenscheid, Ulrich Krieger. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 02.03.2021.)

Background: Mobile health (mHealth) tools have shown promise in clinical photo and wound documentation for their potential to improve workflows, expand access to care, and improve the quality of patient care. However, some barriers to adoption persist., Objective: This study aims to understand the social, organizational, and technical factors affecting clinicians' adoption of a clinical photo documentation mHealth app and its implications for clinical workflows and quality of care., Methods: A qualitative case study of a clinical photo and wound documentation app called imitoCam was conducted. The data were collected through 20 in-depth interviews with mHealth providers, clinicians, and medical informatics experts from 8 clinics and hospitals in Switzerland and Germany., Results: According to the study participants, the use of mHealth in clinical photo and wound documentation provides numerous benefits such as time-saving and efficacy, better patient safety and quality of care, enhanced data security and validation, and better accessibility. The clinical workflow may also improve when the app is a good fit, resulting in better collaboration and transparency, streamlined daily work, clinician empowerment, and improved quality of care. The findings included important factors that may contribute to or hinder adoption. Factors may be related to the material nature of the tool, such as the perceived usefulness, ease of use, interoperability, cost, or security of the app, or social aspects such as personal experience, attitudes, awareness, or culture. Organizational and policy barriers include the available clinical practice infrastructure, workload and resources, the complexity of decision making, training, and ambiguity or lack of regulations. User engagement in the development and implementation process is a vital contributor to the successful adoption of mHealth apps., Conclusions: The promising potential of mHealth in clinical photo and wound documentation is clear and may enhance clinical workflow and quality of care; however, the factors affecting adoption go beyond the technical features of the tool itself to embrace significant social and organizational elements. Technology providers, clinicians, and decision makers should work together to carefully address any barriers to improve adoption and harness the potential of these tools., (©Christine Jacob, Antonio Sanchez-Vazquez, Chris Ivory. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 23.09.2020.)

Background: Repeatedly pushing high-calorie food stimuli away based on joystick movements has been found to reduce approach biases toward these stimuli. Some studies also found that such avoidance training reduced consumption of high-calorie foods., Objective: This study aimed to test effects of a smartphone-based approach-avoidance intervention on chocolate craving and consumption, to make such interventions suitable for daily use., Methods: Within a 10-day period, regular chocolate eaters (n=105, 86% female) performed five sessions during which they continuously avoided (ie, swiped upward) chocolate stimuli (experimental group, n=35), performed five sessions during which they approached and avoided chocolate stimuli equally often (placebo control group, n=35), or did not perform any training sessions (inactive control group, n=35). Training effects were measured during laboratory sessions before and after the intervention period and further continuously through daily ecological momentary assessment., Results: Self-reported chocolate craving and consumption as well as body fat mass significantly decreased from pre- to postmeasurement across all groups. Ecological momentary assessment reports evidenced no differences in chocolate craving and consumption between intervention days and rest days as a function of the group., Conclusions: A smartphone-based approach-avoidance training did not affect eating-related and anthropometric measures over and above measurement-based changes in this study. Future controlled studies need to examine whether other techniques of modifying food approach tendencies show an add-on benefit over conventional, monitoring-based intervention effects., Trial Registration: AsPredicted 8203; https://aspredicted.org/pt9df.pdf., (©Adrian Meule, Anna Richard, Radomir Dinic, Jens Blechert. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 01.11.2019.)

Background: Mobile technologies are increasingly being used to manage chronic diseases, including cancer, with the promise of improving the efficiency and effectiveness of care. Among the myriad of mobile technologies in health care, we have seen an explosion of mobile apps. The rapid increase in digital health apps is not paralleled by a similar trend in usage statistics by clinicians and patients. Little is known about how much and in what ways mobile health (mHealth) apps are used by clinicians and patients for cancer care, what variables affect their use of mHealth, and what patients' and clinicians' expectations of mHealth apps are., Objective: This study aimed to describe the patient and clinician population that uses mHealth in cancer care and to provide recommendations to app developers and regulators to generally increase the use and efficacy of mHealth apps., Methods: Through a cross-sectional Web-based survey, we explored the current utilization rates of mHealth in cancer care and factors that explain the differences in utilization by patients and clinicians across the United States and 5 different countries in Europe. In addition, we conducted an international workshop with more than 100 stakeholders and a roundtable with key representatives of international organizations of clinicians and patients to solicit feedback on the survey results and develop insights into mHealth app development practices., Results: A total of 1033 patients and 1116 clinicians participated in the survey. The proportion of cancer patients using mHealth (294/1033, 28.46%) was far lower than that of clinicians (859/1116, 76.97%). Accounting for age and salary level, the marginal probabilities of use at means are still significantly different between the 2 groups and were 69.8% for clinicians and 38.7% for patients using the propensity score-based regression adjustment with weighting technique. Moreover, our analysis identified a gap between basic and advanced users, with a prevalent use for activities related to the automation of processes and the interaction with other individuals and a limited adoption for side-effect management and compliance monitoring in both groups., Conclusions: mHealth apps can provide access to clinical and economic data that are low cost, easy to access, and personalized. The benefits can go as far as increasing patients' chances of overall survival. However, despite its potential, evidence on the actual use of mobile technologies in cancer care is not promising. If the promise of mHealth is to be fulfilled, clinician and patient usage rates will need to converge. Ideally, cancer apps should be designed in ways that strengthen the patient-physician relationship, ease physicians' workload, be tested for validity and effectiveness, and fit the criteria for reimbursement., (©Rosanna Tarricone, Maria Cucciniello, Patrizio Armeni, Francesco Petracca, Kevin C Desouza, Leslie Kelly Hall, Dorothy Keefe. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 06.09.2019.)

Objective: For dietary assessment, mobile devices with a camera can be used as an alternative to hand-written paper records. The Nutritional Tracking Information Smartphone (Nutris-Phone) study aimed to examine relative validity and feasibility of a photo-based dietary record in everyday life., Design: Parallel to the photo-based technique, a weighed record was performed. Participant satisfaction was assessed by questionnaire. A trained nutrition scientist evaluated portion sizes and nutrient content was calculated (DGExpert). Spearman correlation and Bland-Altman analyses were applied., Setting: Healthy, non-pregnant volunteers (≥18 years) without intent to lose weight recruited at Ulm University, Germany., Subjects: Sixty-six participants (36 % males, median age 22·0 (interquartile range 20·0-25·0) years) took pictures of foods and beverages consumed with a commercially available mobile phone., Results: Significant correlation between the photo-based and weighed record was observed: energy (r=0·991), carbohydrate (r=0·980), fat (r=0·972), protein (r=0·988), fibre (r=0·941). Bland-Altman analyses indicated comparable means and acceptable 95 % limits of agreement (energy: -345·2 to 302·9 kJ (-82·5 to 72·4 kcal); carbohydrate: -15·2 to 13·1 g; fat: -6·4 to 6·4 g; protein: -5·9 to 5·6 g; fibre: -2·7 to 2·5 g). However, with increasing intake level, underestimation by the digital method was present (except for fat, all P&lt;0·01). Over 80 % of participants were satisfied with the photo-based record. In nearly 90 %, technical implementation was without major problems., Conclusions: Compared with a weighed record, the photo-based dietary record seems to be valid, feasible and user-friendly to estimate energy, macronutrient and fibre intakes, although a systematic bias with increasing levels of intake should be kept in mind.