@Article{info:doi/10.2196/59656,
author="Lu, Peng
and Qiu, Jiamin
and Huang, Shiqi
and Wang, Xinman
and Han, Shasha
and Zhu, Sui
and Ning, Youjing
and Zeng, Fang-fang
and Yuan, Yuan",
title="Interventions for Digital Addiction: Umbrella Review of Meta-Analyses",
journal="J Med Internet Res",
year="2025",
month="Feb",
day="11",
volume="27",
pages="e59656",
keywords="digital addiction",
keywords="interventions",
keywords="umbrella reviews",
keywords="systematic review",
keywords="internet addiction",
keywords="loneliness",
keywords="quality of life",
keywords="well-being",
keywords="internet",
keywords="psychological",
keywords="pharmacological treatment",
keywords="cognitive behavioral therapy",
abstract="Background: Numerous studies have explored interventions to reduce digital addiction outcomes, but inconclusive evidence makes it difficult for decision-makers, managers, and clinicians to become familiar with all available literature and find appropriate interventions. Objective: This study aims to summarize and assess the certainty of evidence of interventions proposed to decrease digital addiction from published meta-analyses. Methods: An umbrella review of published meta-analyses was performed. We searched PubMed, Cochrane Library, Web of Science, and Embase for meta-analyses published up to February 2024. Eligible studies evaluated interventions using randomized controlled trials, nonrandomized controlled trials, or quasi-experimental studies and were assessed for methodological quality using Assessment of Multiple Systematic Reviews version 2. A random effects model was used to analyze data, considering heterogeneity and publication bias. Grading of Recommendations, Assessment, Development, and Evaluations was applied to assess evidence with certainty. Results: A total of 5 studies assessing 21 associations were included in the umbrella review, of which 4 (80\%) were high-quality meta-analyses. Weak evidence was observed in 19 associations, whereas null associations appeared in the remaining 2 associations. These associations pertained to 8 interventions (group counseling, integrated internet addiction [IA] prevention programs, psychosocial interventions, reality therapy, self-control training programs, cognitive behavioral therapy, interventions to reduce screen time in children, and exercise) and 9 outcomes (self-control, self-esteem, internet gaming disorder symptoms, time spent gaming, IA scores, screen use time, interpersonal sensitivity longlines, anxiety, and depression). Cognitive behavioral therapy reduces anxiety (standardized mean difference [SMD] 0.939, 95\% CI 0.311 to 1.586), internet gaming disorder symptoms (SMD 1.394, 95\% CI 0.664 to 2.214), time spent gaming (SMD 1.259, 95\% CI, 0.311 to 2.206), and IA scores (SMD --2.097, 95\% CI --2.814 to --1.381). Group counseling had a large effect on improving self-control (SMD 1.296, 95\% CI 0.269 to 2.322) and reducing IA levels (SMD --1.417, 95\% CI --1.836 to --0.997). Exercise intervention reduced IA scores (SMD --2.322, 95\% CI --3.212 to --1.431), depression scores (SMD --1.421, 95\% CI --2.046 to --797), and interpersonal sensitivity scores (SMD --1.433, 95\% CI --2.239 to --0.627). Conclusions: The evidence indicates that current interventions to reduce digital addiction are weak. Data from more and better-designed studies with larger sample sizes are needed to establish robust evidence. Trial Registration: PROSPERO CRD42024528173; crd.york.ac.uk/PROSPERO/display\_record.php?RecordID=528173 ",
doi="10.2196/59656",
url="https://www.jmir.org/2025/1/e59656"
}


@Article{info:doi/10.2196/47927,
author="Duffy, Daniel
and Richards, Derek
and Hisler, Garrett
and Timulak, Ladislav",
title="Implementing Internet-Delivered Cognitive Behavioral Therapy for Depression and Anxiety in Adults: Systematic Review",
journal="J Med Internet Res",
year="2025",
month="Jan",
day="28",
volume="27",
pages="e47927",
keywords="mixed methods systematic review",
keywords="internet-delivered cognitive behavioral therapy",
keywords="iCBT",
keywords="implementation science",
keywords="implementation research",
keywords="depression",
keywords="anxiety",
abstract="Background: Scientific implementation findings relevant to the implementation of internet-delivered cognitive behavioral therapy (iCBT) for depression and anxiety in adults remain sparse and scattered across different sources of published information. Identifying evidence-based factors that influence the implementation of iCBT is key to successfully using iCBT in real-world clinical settings. Objective: This systematic review evaluated the following: (1) aspects that research articles postulate as important for the implementation of iCBT and (2) aspects relevant to the day-to-day running of iCBT services. A mixed methods systematic review using a convergent synthesis design was conducted to bring together evidence across this sparse literature consisting of divergent scientific article types to investigate the implementation of iCBT for depression and anxiety in adults. Methods: We searched the PsycINFO, PsycArticles, MEDLINE, CINAHL Complete, and Embase databases for any published peer-reviewed scientific articles that report on the implementation of iCBT for depression or anxiety disorders in adults. A total of 40 articles spanning the case study, commentary, meta-analysis, mixed methods study, pilot randomized controlled trial, randomized controlled trial, qualitative study, quantitative study, review, and systematic review article types were identified as eligible for this mixed methods review. Data were analyzed qualitatively using the descriptive-interpretive approach. Results: The first domain highlighted the impact of therapist and patient attitudes when implementing iCBT, the superiority of guided iCBT over unguided iCBT, its noninferiority to equivalent face-to-face treatments, and its utility outside of the original target of mild-to-moderate depression and anxiety. In total, 3 subdomains were identified under the second domain: (1) the management of iCBT in the workplace, detailing the importance of managing the iCBT service, related staff, and their motivations for using it; (2) the practice of iCBT in the workplace, describing the therapeutic aspects of iCBT provision, such as the provision of support, the background of supporters, and screening procedures; and (3) contextual considerations, detailing the impact of governmental legislation on therapy conducted over the internet, the lack of an iCBT workforce as a limiting factor, and the cost estimates associated with iCBT provision. Conclusions: Broadly, the findings describe several aspects that should be taken into account when researchers or practitioners implement iCBT as part of their work. However, the findings should be interpreted with caution, as the articles reviewed spanned many article types, and few of the included studies were directly focused on evaluating the implementation of iCBT. While findings provide insight into important factors to consider during iCBT implementation, these findings and their limitations highlight the need for more implementation-specific research in this area. ",
doi="10.2196/47927",
url="https://www.jmir.org/2025/1/e47927"
}


@Article{info:doi/10.2196/64959,
author="Snipes, Cassandra
and Dorner?Ciossek, Cornelia
and Hare, D. Brendan
and Besedina, Olya
and Campellone, Tim
and Petrova, Mariya
and Lakhan, E. Shaheen
and Pratap, Abhishek",
title="Establishment and Maintenance of a Digital Therapeutic Alliance in People Living With Negative Symptoms of Schizophrenia: Two Exploratory Single-Arm Studies",
journal="JMIR Ment Health",
year="2025",
month="Jan",
day="27",
volume="12",
pages="e64959",
keywords="therapeutic alliance",
keywords="digital working alliance",
keywords="experiential negative symptoms",
keywords="schizophrenia",
keywords="digital therapeutics",
keywords="digital literacy",
abstract="Background: Evidence-based digital therapeutics represent a new treatment modality in mental health, potentially providing cost-efficient, accessible means of augmenting existing treatments for chronic mental illnesses. CT-155/BI 3972080 is a prescription digital therapeutic under development as an adjunct to standard of care treatments for patients 18 years of age and older with experiential negative symptoms (ENS) of schizophrenia. Individual components of CT-155/BI 3972080 are designed based on the underlying principles of face-to-face treatment. A positive therapeutic alliance between patients and health care providers is linked with improved clinical outcomes in mental health. Likewise, establishing a similar therapeutic alliance with a digital therapeutic (ie, digital working alliance [DWA]) may be important for engagement and treatment effectiveness of this modality. Objective: This study aimed to investigate the establishment and maintenance of a DWA between a beta version of CT-155/BI 3972080 (CT-155 beta) and adults with ENS of schizophrenia. Methods: Two multicenter, exploratory, single-arm studies (study 1: CT-155-C-001 and study 2: CT-155-C-002) enrolled adults with schizophrenia and ENS receiving stable antipsychotic medication (?12 weeks). Participants had access to CT-155 beta and were presented with daily in-app activities during a 3-week orientation phase that included lessons designed to facilitate building of a DWA. In study 2, the 3-week orientation phase was followed by an abbreviated active 4-week phase. Digital literacy at baseline was evaluated using the Mobile Device Proficiency Questionnaire (MDPQ). The mobile Agnew Relationship Measure (mARM) was used to assess DWA establishment after 3 weeks in both studies, and after 7 weeks in study 2 to assess DWA maintenance. Participant safety, digital literacy, and correlations between negative symptom severity and DWA were assessed in both studies. Results: Of the enrolled participants, 94\% (46/49) and 86\% (43/50) completed studies 1 and 2, respectively. Most were male (study 1: 71\%, 35/49; study 2: 80\%, 40/50). The baseline digital literacy assessed through MDPQ score was comparable in both studies (study 1: mean 30.56, SD 8.06; study 2: mean 28.69, SD 8.31) indicating proficiency in mobile device use. After 3 weeks, mARM scores (study 1: mean 5.16, SD 0.8; study 2: mean 5.36, SD 1.06) indicated that a positive DWA was established in both studies. In study 2, the positive DWA established at week 3 was maintained at week 7 (mARM: mean 5.48, SD 0.97). There were no adverse events (AEs) in study 1, and 3 nonserious and nontreatment-related AEs in study 2. Conclusions: A positive DWA was established between participants and CT-155 beta within 3 weeks. The second 7-week study showed maintenance of the DWA to the end of the study. Results support the establishment and maintenance of a DWA between adults with ENS of schizophrenia and a beta version of CT-155/BI 3972080, a prescription digital therapeutic under development to target these symptoms. Trial Registration: Clinicaltrials.gov NCT05486312; https://clinicaltrials.gov/study/NCT05486312 ",
doi="10.2196/64959",
url="https://mental.jmir.org/2025/1/e64959"
}


@Article{info:doi/10.2196/60150,
author="Tang, Dongmei
and Peng, Yuzhu
and Gu, Dantong
and Wu, Yongzhen
and Li, Huawei",
title="Digital Frequency Customized Relieving Sound for Chronic Subjective Tinnitus Management: Prospective Controlled Study",
journal="J Med Internet Res",
year="2025",
month="Jan",
day="17",
volume="27",
pages="e60150",
keywords="tinnitus",
keywords="digital frequency customized relieving sound",
keywords="unmodified music",
keywords="sound therapy",
keywords="prospective study",
keywords="mobile phone",
abstract="Background: Tinnitus is a major health issue, but currently no tinnitus elimination treatments exist for chronic subjective tinnitus. Acoustic therapy, especially personalized acoustic therapy, plays an increasingly important role in tinnitus treatment. With the application of smartphones, personalized acoustic stimulation combined with smartphone apps will be more conducive to the individualized treatment and management of patients with tinnitus. Objective: The aim of this study was to evaluate the efficacy of a new personalized approach known as the digital frequency customized relieving sound (DFCRS) for tinnitus treatment and to explore the factors that may influence its therapeutic effect. Methods: Patients with subjective tinnitus were enrolled in this study from July 14, 2020, to May 24, 2021, in the tinnitus specialist clinic of Eye and ENT Hospital, Fudan University, Shanghai, China. In this nonrandomized concurrent controlled trial, a total of 107 participants were assigned to listen to personalized DFCRS through our developed app, while the other 77 participants who did not want to download and use the app were assigned to listen to unmodified music (UM). All the recruits were instructed to listen to DFCRS or UM for at least 2 hours a day and complete follow-up assessments at baseline, 1, 2, and 3 months. Multidimensional assessment scales, that is, Tinnitus Handicapped Inventory (THI), Hospital Anxiety and Depression Scale (HADS), Athens Insomnia Scale (AIS), Fear of Tinnitus Questionnaire (FTQ), and Tinnitus Catastrophizing Scale (TCS) were used to evaluate the severity of tinnitus and the quality of life. Linear mixed models were used to test for changes in the THI scores across 3 months of acoustic treatment between group (DFCRS or UM treatment) and time. A multiclass logistic model was built with a stepwise function to determine the influence of the different covariates on the effects of acoustic treatment. Results: The results of the multidimensional assessment scales after 3 months of treatment showed that DFCRS-treated patients had significant tinnitus relief compared to those in the UM group. Linear mixed models revealed a significant reduction in the THI scores over time (P<.001), with the DFCRS group showing significantly greater improvement than the UM group (P<.001). At 3 months, 92.5\% (99/107) of the patients undergoing DFCRS reported tinnitus relief or disappearance, and longer daily treatment time was associated with better outcomes (P=.007). Multiclass logistic regression confirmed that longer treatment time (odds ratio [OR] 13.07-64.78; P<.001) and more severe tinnitus at baseline (OR 10.46-83.71; P<.001) predicted better treatment response. All secondary outcomes (HADS, AIS, FTQ, TCS) showed significant improvements over time (P<.001). Conclusions: Our study suggests that DFCRS is a new promising and noninvasive therapy for chronic tinnitus, and it can be delivered through a mobile app to bring more convenience to patients with tinnitus. ",
doi="10.2196/60150",
url="https://www.jmir.org/2025/1/e60150"
}


@Article{info:doi/10.2196/59027,
author="Liu, Shiyu
and Ma, Jingru
and Sun, Meichen
and Zhang, Chao
and Gao, Yujing
and Xu, Jinghong",
title="Mapping the Landscape of Digital Health Intervention Strategies: 25-Year Synthesis",
journal="J Med Internet Res",
year="2025",
month="Jan",
day="13",
volume="27",
pages="e59027",
keywords="digital health interventions",
keywords="intervention strategies",
keywords="behavior change",
keywords="mHealth",
keywords="eHealth",
keywords="randomized controlled trial",
abstract="Background: Digital health interventions have emerged as promising tools to promote health behavior change and improve health outcomes. However, a comprehensive synthesis of strategies contributing to these interventions is lacking. Objective: This study aims to (1) identify and categorize the strategies used in digital health interventions over the past 25 years; (2) explore the differences and changes in these strategies across time periods, countries, populations, delivery methods, and senders; and (3) serve as a valuable reference for future researchers and practitioners to improve the effectiveness of digital health interventions. Methods: This study followed a systematic review approach, complemented by close reading and text coding. A comprehensive search for published English academic papers from PubMed, Web of Science, and Scopus was conducted. The search employed a combination of digital health and intervention-related terms, along with database-specific subject headings and filters. The time span covered 25 years, from January 1, 1999, to March 10, 2024. Sample papers were selected based on study design, intervention details, and strategies. The strategies were identified and categorized based on the principles of Behavior Change Techniques and Behavior Strategies. Results: A total of 885 papers involving 954,847 participants met the eligibility criteria. We identified 173 unique strategies used in digital health interventions, categorized into 19 themes. The 3 most frequently used strategies in the sample papers were ``guide'' (n=492, 55.6\%), ``monitor'' (n=490, 55.4\%), and ``communication'' (n=392, 44.3\%). The number of strategies employed in each paper ranged from 1 to 32. Most interventions targeted clients (n=844, 95.4\%) and were carried out in hospitals (n=268, 30.3\%). High-income countries demonstrated a substantially higher number and diversity of identified strategies than low- and middle-income countries, and the number of studies targeting the public (n=647, 73.1\%) far exceeded those focusing on vulnerable groups (n=238, 26.9\%). Conclusions: Digital health interventions and strategies have undergone considerable development over the past 25 years. They have evolved from simple approaches to sophisticated, personalized techniques and are trending toward multifaceted interventions, leveraging advanced technologies for real-time monitoring and feedback. Future studies should focus on rigorous evaluations, long-term effectiveness, and tailored approaches for diverse populations, and more attention should be given to vulnerable groups. ",
doi="10.2196/59027",
url="https://www.jmir.org/2025/1/e59027",
url="http://www.ncbi.nlm.nih.gov/pubmed/39804697"
}


@Article{info:doi/10.2196/59093,
author="Zhang, Lin
and Huang, Shuang
and Liu, Sha
and Huang, Yuanxiu
and Chen, Shan
and Hu, Jinsong
and Xu, Mingzhong",
title="Effectiveness of an Internet-Based Acceptance and Commitment Therapy Intervention for Reducing Psychological Distress in Health Care Professionals: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2024",
month="Dec",
day="18",
volume="26",
pages="e59093",
keywords="acceptance and commitment therapy",
keywords="internet-based intervention",
keywords="stress",
keywords="anxiety",
keywords="depression",
keywords="burnout",
keywords="health care professionals",
keywords="randomized controlled trial",
abstract="Background: Psychological distress is prevalent among health care professionals and can lead to poor-quality patient care. Internet-based acceptance and commitment therapy (iACT) is a promising intervention for improving mental health due to its low cost and easy access. However, there is limited evidence of its effectiveness in reducing health care professionals' psychological distress. Objective: This study aims to examine the effects of iACT on psychological distress (stress, anxiety, and depression) among health care professionals in China. Methods: From October 2022 to February 2023, a total of 108 health care professionals were recruited via WeChat and randomized into a 6-week iACT intervention program with therapist support (n=54) or waitlist control group (n=54). The intervention included 21 self-guided sessions combining teaching videos, mindfulness practices, and journal writing, followed by 7 live conferences to share experiences and discuss questions, all conducted via WeChat. Primary outcomes (stress, anxiety, and depression) and secondary outcomes (burnout and psychological flexibility) were collected using the Sojump platform, the most popular web-based survey platform in China. Generalized estimating equations were used to compare the outcomes between groups and assess the effects of group, time, and group-by-time interaction. Subgroup and sensitive analyses were performed to test the robustness of our findings across various groups. Results: Among the 108 health care professionals, 68 (63\%) completed the follow-up assessment at week 10, including 35 (64.8\%) in the iACT group and 33 (61.1\%) in the waitlist control group. Of the 54 participants in the iACT group, all attended at least 2 sessions, and 25 attended all 28 sessions. On average, participants attended 20 (71\%) sessions. The iACT group showed significant improvement in the Depression Anxiety and Stress Scales-21 total score (d=0.82, 95\% CI 0.39-1.26), and the effects were sustained for 4 weeks after the intervention (d=1.08, 95\% CI 0.57-1.59). Compared to the control group, the iACT group showed significantly lower scores in burnout at week 6 (d=1.42, 95\% CI 0.95-1.89) and week 10 (d=1.52, 95\% CI 0.98-2.06). The iACT group showed significantly higher psychological flexibility at week 6 (d=1.23, 95\% CI 0.77-1.69) and week 10 (d=1.15, 95\% CI 0.64-1.66). Conclusions: The iACT effectively decreased health care professionals' psychological distress and burnout and improved their psychological flexibility. Our findings provide implications and guidance for the development and broad implementation of iACT in health care settings to improve the mental health of health care professionals. Trial Registration: Chinese Clinical Trial Register ChiCTR2400093584; https://tinyurl.com/38werwsk ",
doi="10.2196/59093",
url="https://www.jmir.org/2024/1/e59093",
url="http://www.ncbi.nlm.nih.gov/pubmed/39693127"
}


@Article{info:doi/10.2196/56574,
author="Ridout, J. Samuel
and Ridout, K. Kathryn
and Lin, Y. Teresa
and Campbell, I. Cynthia",
title="Clinical Use of Mental Health Digital Therapeutics in a Large Health Care Delivery System: Retrospective Patient Cohort Study and Provider Survey",
journal="JMIR Ment Health",
year="2024",
month="Oct",
day="2",
volume="11",
pages="e56574",
keywords="digital therapeutics",
keywords="depression",
keywords="anxiety",
keywords="mental health",
keywords="retrospective cohort",
keywords="electronic health record",
keywords="adults",
keywords="survey",
keywords="recommendation",
keywords="mobile phone",
abstract="Background: While the number of digital therapeutics (DTx) has proliferated, there is little real-world research on the characteristics of providers recommending DTx, their recommendation behaviors, or the characteristics of patients receiving recommendations in the clinical setting. Objective: The aim of this study was to characterize the clinical and demographic characteristics of patients receiving DTx recommendations and describe provider characteristics and behaviors regarding DTx. Methods: This retrospective cohort study used electronic health record data from a large, integrated health care delivery system. Demographic and clinical characteristics of adult patients recommended versus not recommended DTx by a mental health provider between May 2020 and December 2021 were examined. A cross-sectional survey of mental health providers providing these recommendations was conducted in December 2022 to assess the characteristics of providers and recommendation behaviors related to DTx. Parametric and nonparametric tests were used to examine statistical significance between groups. Results: Of 335,250 patients with a mental health appointment, 53,546 (16\%) received a DTx recommendation. Patients recommended to DTx were younger, were of Asian or Hispanic race or ethnicity, were female, were without medical comorbidities, and had commercial insurance compared to those without a DTx recommendation (P<.001). More patients receiving a DTx recommendation had anxiety or adjustment disorder diagnoses, but less had depression, bipolar, or psychotic disorder diagnoses (P<.001) versus matched controls not recommended to DTx. Overall, depression and anxiety symptom scores were lower in patients recommended to DTx compared to matched controls not receiving a recommendation, although female patients had a higher proportion of severe depression and anxiety scores compared to male patients. Provider survey results indicated a higher proportion of nonprescribers recommended DTx to patients compared to prescribers (P=.008). Of all providers, 29.4\% (45/153) reported using the suggested internal electronic health record--based tools (eg, smart text) to recommend DTx, and of providers recommending DTx resources to patients, 64.1\% (98/153) reported they follow up with patients to inquire on DTx benefits. Only 38.4\% (58/151) of respondents report recommending specific DTx modules, and of those, 58.6\% (34/58) report following up on the impact of these specific modules. Conclusions: DTx use in mental health was modest and varied by patient and provider characteristics. Providers do not appear to actively engage with these tools and integrate them into treatment plans. Providers, while expressing interest in potential benefits from DTx, may view DTx as a passive strategy to augment traditional treatment for select patients. ",
doi="10.2196/56574",
url="https://mental.jmir.org/2024/1/e56574"
}


@Article{info:doi/10.2196/59013,
author="Goeldner, Moritz
and Gehder, Sara",
title="Digital Health Applications (DiGAs) on a Fast Track: Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024",
journal="J Med Internet Res",
year="2024",
month="Aug",
day="29",
volume="26",
pages="e59013",
keywords="digital health application",
keywords="DiGA",
keywords="data-driven analysis",
keywords="clinical evidence",
keywords="health economics",
keywords="positive care effect",
keywords="medical benefit",
keywords="patient-relevant structural and procedural improvements",
keywords="pSVV",
keywords="digital health care act",
abstract="Background: This study aimed to analyze the rapidly evolving ecosystem of digital health applications (Digitale Gesundheitsanwendung; DiGAs) in Germany, spurred by the 2019 Digital Healthcare Act. With over 73 million people in Germany now having access to DiGAs, these prescribable digital health apps and web-based applications represent a substantial stride in health care modernization, supporting both patients and health care providers with digital solutions for disease management and care improvement. Objective: Through a data-driven approach, this research aimed to unpack the complexities of DiGA market dynamics, economic factors, and clinical evidence, offering insights into their impact over the past years. Methods: The analysis draws from a range of public data sources, including the DiGA directory, statutory health insurance reports, app store feedback, and clinical study results. Results: As of July 1, 2024, there are 56 DiGAs listed by the Federal Institute for Drugs and Medical Devices (Bundesinstitut f{\"u}r Arzneimittel und Medizinprodukte), divided into 35 permanently and 21 preliminarily listed applications. Our findings reveal that a majority of DiGAs extend beyond the intended 1-year period to achieve permanent listing, reflecting the extensive effort required to demonstrate clinical efficacy. Economic analysis uncovered a dynamic pricing landscape, with initial prices ranging from approximately {\texteuro}200 to {\texteuro}700 ({\texteuro}1=US \$1.07), averaging at a median of {\texteuro}514 for a 3-month DiGA prescription. Following negotiations or arbitration board decisions, prices typically see a 50\% reduction, settling at a median of {\texteuro}221. Prescription data offer valuable insights into DiGA acceptance, with total prescriptions jumping from around 41,000 in the first period to 209,000 in the latest reporting period. The analysis of the top 15 DiGAs, representing 82\% of the total prescriptions, shows that these best-performing apps receive from a minimum of 8 to a maximum of 77 daily prescriptions, with native apps and early market entrants achieving higher rates. Clinical evidence from all 35 permanently listed DiGAs indicates a uniform preference for randomized controlled trials to validate primary end points, with no noteworthy use of alternative study designs encouraged in the Digital Healthcare Act and related regulations. Moreover, all evaluated DiGAs focused on medical benefits, with health status improvement as a key end point, suggesting an underuse of patient-relevant structural and procedural improvement in demonstrating health care impact. Conclusions: This study highlights the growth and challenges within the DiGA sector, suggesting areas for future research, such as the exploration of new study designs and the potential impact of patient-relevant structural and procedural improvements. For DiGA manufacturers, the strategic advantage of early market entry is emphasized. Overall, this paper underscores the evolving landscape of digital health, advocating for a nuanced understanding of digital health technology integration in Germany and beyond. ",
doi="10.2196/59013",
url="https://www.jmir.org/2024/1/e59013"
}


@Article{info:doi/10.2196/55366,
author="De Lucia, Annalisa
and Perlini, Cinzia
and Chiarotto, Alessandro
and Pachera, Sara
and Pasini, Ilenia
and Del Piccolo, Lidia
and Donisi, Valeria",
title="eHealth-Integrated Psychosocial and Physical Interventions for Chronic Pain in Older Adults: Scoping Review",
journal="J Med Internet Res",
year="2024",
month="Jul",
day="29",
volume="26",
pages="e55366",
keywords="chronic pain",
keywords="older adults",
keywords="eHealth",
keywords="scoping review",
keywords="psychological intervention",
keywords="physical intervention",
keywords="multimodal intervention",
keywords="biopsychosocial model for chronic pain",
keywords="self-management",
keywords="mobile phone",
abstract="Background: Chronic noncancer pain (CNCP) is highly present among older adults, affecting their physical, psychological, and social functioning. A biopsychosocial multimodal approach to CNCP management is currently extensively suggested by international clinical practice guidelines. Recently, the growing development and application of eHealth within pain management has yielded encouraging results in terms of effectiveness and feasibility; however, its use among the older population remains underexamined. Objective: The overall aim of this scoping review was to systematically map existing literature about eHealth multimodal interventions (including both physical and psychosocial components) targeting older adults with CNCP. Methods: This review adhered to the JBI methodology, a protocol was a priori registered as a preprint on the medRxiv platform, and the results were reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Four electronic databases (PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and PsycINFO) were systematically searched for relevant articles. Studies were included if they reported on multimodal interventions (including both physical and psychosocial components) delivered through any eHealth modality to an older population with any type of CNCP. Two reviewers selected the studies: first by screening titles and abstracts and second by screening full-text articles. The quality of the included studies was evaluated using the Quality Assessment Tool for Studies with Diverse Designs. The results of the studies were summarized narratively. Results: A total of 9 studies (n=6, 67\% published between 2021 and 2023) with quality rated as medium to high were included, of which 7 (78\%) were randomized controlled trials (n=5, 71\% were pilot and feasibility studies). All the included studies evaluated self-management interventions, most of them (n=7, 78\%) specifically designed for older adults. The participants were aged between 65 and 75 years on average (mean 68.5, SD 3.5 y) and had been diagnosed with different types of CNCP (eg, osteoarthritis and chronic low back pain). Most of the included studies (5/9, 56\%) involved the use of multiple eHealth modalities, with a higher use of web-based programs and video consulting. Only 1 (11\%) of the 9 studies involved a virtual reality--based intervention. The evaluated interventions showed signs of effectiveness in the targeted biopsychosocial outcomes, and the participants' engagement and ratings of satisfaction were generally positive. However, several research gaps were identified and discussed. Conclusions: Overall, of late, there has been a growing interest in the potential that eHealth multimodal interventions offer in terms of improving pain, physical, and psychosocial outcomes in older adults with CNCP. However, existing literature on this topic still seems scarce and highly heterogeneous, with few proper randomized controlled trials, precluding robust conclusions. Several gaps emerged in terms of the older population considered and the lack of evaluation of comorbidities. International Registered Report Identifier (IRRID): RR2-10.1101/2023.07.27.23293235 ",
doi="10.2196/55366",
url="https://www.jmir.org/2024/1/e55366",
url="http://www.ncbi.nlm.nih.gov/pubmed/39073865"
}


@Article{info:doi/10.2196/49982,
author="Giebel, Denk Godwin
and Abels, Carina
and Plescher, Felix
and Speckemeier, Christian
and Schrader, Frederik Nils
and B{\"o}rchers, Kirstin
and Wasem, J{\"u}rgen
and Neusser, Silke
and Blase, Nikola",
title="Problems and Barriers Related to the Use of mHealth Apps From the Perspective of Patients: Focus Group and Interview Study",
journal="J Med Internet Res",
year="2024",
month="Apr",
day="23",
volume="26",
pages="e49982",
keywords="mobile health",
keywords="mHealth",
keywords="mHealth app",
keywords="patient",
keywords="problems",
keywords="barriers",
keywords="digital health applications",
keywords="DiGA",
keywords="app",
keywords="barrier",
keywords="mobile app",
keywords="health care system",
keywords="economic outcome",
keywords="context",
keywords="mobile phone",
abstract="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. ",
doi="10.2196/49982",
url="https://www.jmir.org/2024/1/e49982",
url="http://www.ncbi.nlm.nih.gov/pubmed/38652508"
}


@Article{info:doi/10.2196/48345,
author="Schroeder, Tanja
and Haug, Maximilian
and Georgiou, Andrew
and Seaman, Karla
and Gewald, Heiko",
title="Evidence of How Physicians and Their Patients Adopt mHealth Apps in Germany: Exploratory Qualitative Study",
journal="JMIR Mhealth Uhealth",
year="2024",
month="Jan",
day="17",
volume="12",
pages="e48345",
keywords="mobile health apps",
keywords="DiGA",
keywords="adoption",
keywords="prescription",
keywords="mHealth",
keywords="aging and individual differences",
abstract="Background: The enactment of the ``Act to Improve Healthcare Provision through Digitalisation and Innovation '' (Digital Healthcare Act; Digitale-Versorgung-Gesetz [DVG]) in Germany has introduced a paradigm shift in medical practice, allowing physicians to prescribe mobile health (mHealth) apps alongside traditional medications. This transformation imposes a dual responsibility on physicians to acquaint themselves with qualifying apps and align them with patient diagnoses, while requiring patients to adhere to the prescribed app use, similar to pharmaceutical adherence. This transition, particularly challenging for older generations who are less skilled with technology, underscores a significant evolution in Germany's medical landscape. Objective: This study aims to investigate physicians' responses to this novel treatment option, their strategies for adapting to this form of prescription, and the willingness of patients to adhere to prescribed mHealth apps. Methods: Using an exploratory qualitative study design, we conducted semistructured interviews with 28 physicians and 30 potential patients aged 50 years and older from August 2020 to June 2021. Results: The findings reveal several factors influencing the adoption of mHealth apps, prompting a nuanced understanding of adoption research. Notably, both physicians and patients demonstrated a lack of information regarding mHealth apps and their positive health impacts, contributing to a deficiency in trust. Physicians' self-perceived digital competence and their evaluation of patients' digital proficiency emerge as pivotal factors influencing the prescription of mHealth apps. Conclusions: Our study provides comprehensive insights into the prescription process and the fundamental factors shaping the adoption of mHealth apps in Germany. The identified information gaps on both the physicians' and patients' sides contribute to a trust deficit and hindered digital competence. This research advances the understanding of adoption dynamics regarding digital health technologies and highlights crucial considerations for the successful integration of digital health apps into medical practice. ",
doi="10.2196/48345",
url="https://mhealth.jmir.org/2024/1/e48345",
url="http://www.ncbi.nlm.nih.gov/pubmed/38231550"
}


@Article{info:doi/10.2196/47407,
author="Sim, Boram
and Ju, Han Jin
and Kim, Byungsoo
and Lee, Yong Jin",
title="Stakeholders' Perceptions Regarding Digital Therapeutics Reimbursement in South Korea: Qualitative Study",
journal="JMIR Mhealth Uhealth",
year="2023",
month="Oct",
day="30",
volume="11",
pages="e47407",
keywords="digital therapeutics",
keywords="digital technology",
keywords="mobile applications",
keywords="internet-based intervention",
keywords="reimbursement mechanism",
keywords="qualitative research",
keywords="perception",
keywords="reimbursement",
keywords="software",
keywords="intervention",
keywords="stakeholder",
keywords="implementation",
keywords="opinion",
keywords="reimbursement method",
abstract="Background: Digital therapeutics (DTx) are therapeutic interventions driven by software and directly provided to patients, allowing them to manage their health with ease in any setting. A growing interest in DTx has spurred a discussion concerning their reimbursement pathways. However, DTx are still at a premature stage, with insufficient evidence on effectiveness, efficiency, and safety. Currently, although industries desire to quickly enter the market, especially by getting their products reimbursed by the National Health Insurance (NHI) fund, the NHI is cautious about DTx due to their uncertainties. Thus, public discussion and social consensus are crucial in deciding whether to reimburse DTx by the NHI fund. Objective: This study examined multiple stakeholders' awareness and attitudes toward DTx and perceptions of regulatory pathways for adopting DTx. Methods: In-depth interviews were conducted with 11 stakeholders in South Korea (industry: n=4, health care: n=3, academia: n=2, and consumer: n=2) using semistructured guidelines. They were purposively sampled to identify individuals with expertise in DTx and NHI policies. The interviews were conducted either in person or via a videoconference for 45-70 minutes. Qualitative data were analyzed using directed content analysis, which uses interview guidelines as an analytical framework. Results: Findings were divided into three categories: (1) awareness and attitude toward DTx, (2) perception of whether DTx are worth entering the market and being reimbursed by the NHI fund, and (3) perception of how to enter the market and how to reimburse DTx by the NHI fund if they are worth it. Although consumer stakeholders were not familiar with the basic concept of DTx, the other stakeholders understood it thoroughly. However, all participants showed positive attitudes and acceptance of DTx. Most of them responded that DTx are worth entering the market, but they could not reach an agreement on the pathways for DTx to enter the market. Although participants were in favor of the reimbursement of DTx in principle, they responded that a conservative approach is required due to insufficient clinical evidence for DTx. Conclusions: We found that stakeholders in South Korea had positive attitudes toward DTx, perceived them as worth using, and agreed to allow them to enter the market. The main issue was not the problem of the technology itself but the difference in opinion as to the pathways for reimbursement. Therefore, this study concluded that the NHI fund, which is operated very conservatively, is insufficient to quickly adopt and implement DTx. Various reimbursement methods, including tax-based financing, raising innovation funds for new technologies, and pilot studies using the NHI fund, should be used to rapidly generate clinical evidence and reduce the uncertainties of DTx to secure a stable market. ",
doi="10.2196/47407",
url="https://mhealth.jmir.org/2023/1/e47407"
}


@Article{info:doi/10.2196/43775,
author="Teepe, Wilhelm Gisbert
and Kowatsch, Tobias
and Hans, Patricius Felix
and Benning, Leo",
title="Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis",
journal="J Med Internet Res",
year="2023",
month="Feb",
day="27",
volume="25",
pages="e43775",
keywords="digital therapeutics",
keywords="digital health",
keywords="musculoskeletal diseases",
keywords="exercise training",
abstract="Background: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of ``Digitale Gesundheitsanwendungen'' (DiGAs; Digital Health Applications) as collectively funded medical services through the ``Digitale-Versorgung-Gesetz'' (Digital Health Care Act) in 2019. Objective: This article presents real-world prescription data collected through the smartphone-based home exercise program ``Vivira,'' a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. Methods: This study included 3629 patients (71.8\% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. Results: Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T3628=5308;?P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). Conclusions: This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care. Trial Registration: German Clinical Trials Register DRKS00024051; https://drks.de/search/en/trial/DRKS00024051 ",
doi="10.2196/43775",
url="https://www.jmir.org/2023/1/e43775",
url="http://www.ncbi.nlm.nih.gov/pubmed/36848211"
}


@Article{info:doi/10.2196/43561,
author="Alkhaldi, Ohoud
and McMillan, Brian
and Maddah, Noha
and Ainsworth, John",
title="Interventions Aimed at Enhancing Health Care Providers' Behavior Toward the Prescription of Mobile Health Apps: Systematic Review",
journal="JMIR Mhealth Uhealth",
year="2023",
month="Feb",
day="27",
volume="11",
pages="e43561",
keywords="mHealth",
keywords="mobile apps",
keywords="prescription",
keywords="behavioral change",
keywords="mobile phone",
abstract="Background: Mobile health (mHealth) apps have great potential to support the management of chronic conditions. Despite widespread acceptance of mHealth apps by the public, health care providers (HCPs) are reluctant to prescribe or recommend such apps to their patients. Objective: This study aimed to classify and evaluate interventions aimed at encouraging HCPs to prescribe mHealth apps. Methods: A systematic literature search was conducted to identify studies published from January 1, 2008, to August 5, 2022, using 4 electronic databases: MEDLINE, Scopus, CINAHL, and PsycINFO. We included studies that evaluated interventions encouraging HCPs to prescribe mHealth apps. Two review authors independently assessed the eligibility of the studies. The ``National Institute of Health's quality assessment tool for before-and-after (pretest-posttest design) studies with no control group'' and ``the mixed methods appraisal tool (MMAT)'' were used to assess the methodological quality. Owing to high levels of heterogeneity between interventions, measures of practice change, specialties of HCPs, and modes of delivery, we conducted a qualitative analysis. We adopted the behavior change wheel as a framework for classifying the included interventions according to intervention functions. Results: In total, 11 studies were included in this review. Most of the studies reported positive findings, with improvements in a number of outcomes, including increased knowledge of mHealth apps among clinicians, improved self-efficacy or confidence in prescribing, and an increased number of mHealth app prescriptions. On the basis of the behavior change wheel, 9 studies reported elements of environmental restructuring such as providing HCPs with lists of apps, technological systems, time, and resources. Furthermore, 9 studies included elements of education, particularly workshops, class lectures, individual sessions with HCPs, videos, or toolkits. Furthermore, training was incorporated in 8 studies using case studies or scenarios or app appraisal tools. Coercion and restriction were not reported in any of the interventions included. The quality of the studies was high in relation to the clarity of aims, interventions, and outcomes but weaker in terms of sample size, power calculations, and duration of follow-up. Conclusions: This study identified interventions to encourage app prescriptions by HCPs. Recommendations for future research should consider previously unexplored intervention functions such as restrictions and coercion. The findings of this review can help inform mHealth providers and policy makers regarding the key intervention strategies impacting mHealth prescriptions and assist them in making informed decisions to encourage this adoption. ",
doi="10.2196/43561",
url="https://mhealth.jmir.org/2023/1/e43561",
url="http://www.ncbi.nlm.nih.gov/pubmed/36848202"
}


@Article{info:doi/10.2196/38649,
author="Teepe, Wilhelm Gisbert
and Kowatsch, Tobias
and Hans, Patricius Felix
and Benning, Leo",
title="Preliminary Use and Outcome Data of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time Series and Matched Analysis",
journal="JMIR Mhealth Uhealth",
year="2022",
month="Dec",
day="2",
volume="10",
number="12",
pages="e38649",
keywords="digital health",
keywords="home exercise",
keywords="musculoskeletal conditions",
keywords="digital intervention",
keywords="exercise",
keywords="physical activity",
keywords="smartphone",
keywords="pain",
keywords="management",
keywords="back pain",
keywords="hip pain",
keywords="knee pain",
keywords="mobility",
keywords="intervention",
abstract="Background: Musculoskeletal conditions are among the main contributors to the global burden of disease. International guidelines consider patient education and movement exercises as the preferred therapeutic option for unspecific and degenerative musculoskeletal conditions. Innovative and decentralized therapeutic means are required to provide access to and availability of such care to meet the increasing therapeutic demand for this spectrum of conditions. Objective: This retrospective observational study of preliminary use and outcome data explores the clinical outcomes of Vivira (hereafter referred to as ``program''), a smartphone-based program for unspecific and degenerative pain in the back, hip, and knee before it received regulatory approval for use in the German statutory health insurance system. Methods: An incomplete matched block design was employed to assess pain score changes over the intended 12-week duration of the program. Post hoc analyses were performed. In addition, a matched comparison of self-reported functional scores and adherence rates is presented. Results: A total of 2517 participants met the inclusion criteria and provided sufficient data to be included in the analyses. Overall, initial self-reported pain scores decreased significantly from an average of 5.19 out of 10 (SD 1.96) to an average of 3.35 out of 10 (SD 2.38) after 12 weeks. Post hoc analyses indicate a particularly emphasized pain score reduction over the early use phases. Additionally, participants with back pain showed significant improvements in strength and mobility scores, whereas participants with hip or knee pain demonstrated significant improvements in their coordination scores. Across all pain areas and pain durations, a high yet expected attrition rate could be observed. Conclusions: This observational study provides the first insights into the clinical outcomes of an exercise program for unspecific and degenerative back, hip, and knee pain. Furthermore, it demonstrates a potential secondary benefit of improved functionality (ie, strength, mobility, coordination). However, as this study lacks confirmatory power, further research is required to substantiate the clinical outcomes of the program assessed. Trial Registration: German Clinical Trials Register DRKS00021785; https://drks.de/search/en/trial/DRKS00021785 ",
doi="10.2196/38649",
url="https://mhealth.jmir.org/2022/12/e38649",
url="http://www.ncbi.nlm.nih.gov/pubmed/36459399"
}


@Article{info:doi/10.2196/31744,
author="Taylor, Heather
and Cavanagh, Kate
and Field, P. Andy
and Strauss, Clara",
title="Health Care Workers' Need for Headspace: Findings From a Multisite Definitive Randomized Controlled Trial of an Unguided Digital Mindfulness-Based Self-help App to Reduce Healthcare Worker Stress",
journal="JMIR Mhealth Uhealth",
year="2022",
month="Aug",
day="25",
volume="10",
number="8",
pages="e31744",
keywords="self-help",
keywords="mindfulness",
keywords="randomized control trial",
keywords="health care worker",
keywords="National Health Service",
keywords="NHS",
keywords="doctors",
keywords="nurses",
keywords="stress",
keywords="mental health",
keywords="burnout",
keywords="mobile phone",
abstract="Background: Health care workers experience high stress. Accessible, affordable, and effective approaches to reducing stress are lacking. In-person mindfulness-based interventions can reduce health care worker stress but are not widely available or accessible to busy health care workers. Unguided, digital, mindfulness-based self-help (MBSH) interventions show promise and can be flexibly engaged with. However, their effectiveness in reducing health care worker stress has not yet been explored in a definitive trial. Objective: This study aimed to investigate the effectiveness of an unguided digital MBSH app (Headspace) in reducing health care worker stress. Methods: This was a definitive superiority randomized controlled trial with 2182 National Health Service staff in England recruited on the web and allocated in a 1:1 ratio to fully automated Headspace (n=1095, 50.18\%) or active control (Moodzone; n=1087, 49.82\%) for 4.5 months. Outcomes were subscales of the Depression, Anxiety, and Stress (primary outcome) Scale short form; Short Warwick Edinburgh Mental Well-being Scale; Maslach Burnout Inventory; 15-item Five-Facet Mindfulness Questionnaire minus Observe items; Self-Compassion Scale--Short Form; Compassionate Love Scale; Penn State Worry Questionnaire; Brooding subscale of the Ruminative Response Scale; and sickness absence. Results: Intention-to-treat analyses found that Headspace led to greater reductions in stress over time than Moodzone (b=--0.31, 95\% CI --0.47 to --0.14; P<.001), with small effects. Small effects of Headspace versus Moodzone were found for depression (b=--0.24, 95\% CI --0.40 to --0.08; P=.003), anxiety (b=--0.19, 95\% CI --0.32 to --0.06; P=.004), well-being (b=0.14, 95\% CI 0.05-0.23; P=.002), mindfulness (b=0.22, 95\% CI 0.09-0.34; P=.001), self-compassion (b=0.48, 95\% CI 0.33-0.64; P<.001), compassion for others (b=0.02, 95\% CI 0.00-0.04; P=.04), and worry (b=--0.30, 95\% CI --0.51 to --0.09; P=.005) but not for burnout (b=--0.19, --0.04, and 0.13, all 95\% CIs >0; P=.65, .67, and .35), ruminative brooding (b=--0.06, 95\% CI --0.12 to 0.00; P=.06), or sickness absence ($\gamma$=0.09, 95\% CI --0.18 to 0.34). Per-protocol effects of Headspace (454/1095, 41.46\%) versus Moodzone (283/1087, 26.03\%) over time were found for stress, self-compassion, and compassion for others but not for the other outcomes. Engagement (practice days per week) and improvements in self-compassion during the initial 1.5-month intervention period mediated pre- to postintervention improvements in stress. Improvements in mindfulness, rumination, and worry did not mediate pre- to postintervention improvements in stress. No serious adverse events were reported. Conclusions: An unguided digital MBSH intervention (Headspace) can reduce health care workers' stress. Effect sizes were small but could have population-level benefits. Unguided digital MBSH interventions can be part of the solution to reducing health care worker stress alongside potentially costlier but potentially more effective in-person mindfulness-based interventions, nonmindfulness courses, and organizational-level interventions. Trial Registration: International Standard Randomised Controlled Trial Number ISRCTN15424185; https://tinyurl.com/rv9en5kc ",
doi="10.2196/31744",
url="https://mhealth.jmir.org/2022/8/e31744",
url="http://www.ncbi.nlm.nih.gov/pubmed/36006668"
}


@Article{info:doi/10.2196/31102,
author="Gerner, Maximilian
and Vuillerme, Nicolas
and Aubourg, Timoth{\'e}e
and Messner, Eva-Maria
and Terhorst, Yannik
and H{\"o}rmann, Verena
and Ganzleben, Ingo
and Schenker, Hannah
and Schett, Georg
and Atreya, Raja
and Neurath, F. Markus
and Knitza, Johannes
and Orlemann, Till",
title="Review and Analysis of German Mobile Apps for Inflammatory Bowel Disease Management Using the Mobile Application Rating Scale: Systematic Search in App Stores and Content Analysis",
journal="JMIR Mhealth Uhealth",
year="2022",
month="May",
day="3",
volume="10",
number="5",
pages="e31102",
keywords="mHealth",
keywords="IBD",
keywords="ulcerative colitis",
keywords="Crohn disease",
keywords="inflammatory bowel disease",
keywords="telemedicine",
keywords="mobile apps",
keywords="rating",
keywords="rating scale",
keywords="quality",
keywords="usability",
keywords="chronic disease",
keywords="IBS",
keywords="app store",
abstract="Background: Patients suffering from inflammatory bowel disease (IBD) frequently need long-term medical treatment. Mobile apps promise to complement and improve IBD management, but so far there has been no scientific analysis of their quality. Objective: This study evaluated the quality of German mobile apps targeting IBD patients and physicians treating IBD patients using the Mobile Application Rating Scale (MARS). Methods: The German Apple App Store and Google Play Store were systematically searched to identify German IBD mobile apps for patient and physician use. MARS was used by 6 physicians (3 using Android smartphones and 3 using iPhones) to independently assess app quality. Apps were randomly assigned so that the 4 apps with the most downloads were rated by all raters and the remaining apps were rated by 1 Android and 1 iOS user. Results: In total, we identified 1764 apps in the Apple App Store and Google Play Store. After removing apps that were not related to IBD (n=1386) or not available in German (n=317), 61 apps remained. After removing duplicates (n=3) and apps for congresses (n=7), journals (n=4), and clinical studies (n=6), as well as excluding apps that were available in only 1 of the 2 app stores (n=20) and apps that could only be used with an additional device (n=7), we included a total of 14 apps. The app ``CED Dokumentation und Tipps'' had the highest overall median MARS score at 4.11/5. On the whole, the median MARS scores of the 14 apps ranged between 2.38/5 and 4.11/5. As there was no significant difference between iPhone and Android raters, we used the Wilcoxon comparison test to calculate P values. Conclusions: The MARS ratings showed that the quality of German IBD apps varied. We also discovered a discrepancy between app store ratings and MARS ratings, highlighting the difficulty of assessing perceived app quality. Despite promising results from international studies, there is little evidence for the clinical benefits of German IBD apps. Clinical studies and patient inclusion in the app development process are needed to effectively implement mobile apps in routine care. ",
doi="10.2196/31102",
url="https://mhealth.jmir.org/2022/5/e31102",
url="http://www.ncbi.nlm.nih.gov/pubmed/35503246"
}


@Article{info:doi/10.2196/32702,
author="Giebel, Denk Godwin
and Speckemeier, Christian
and Abels, Carina
and B{\"o}rchers, Kirstin
and Wasem, J{\"u}rgen
and Blase, Nikola
and Neusser, Silke",
title="Problems and Barriers Related to the Use of Digital Health Applications: Protocol for a Scoping Review",
journal="JMIR Res Protoc",
year="2022",
month="Apr",
day="21",
volume="11",
number="4",
pages="e32702",
keywords="digital health application",
keywords="DHA",
keywords="mHealth, problems, barriers, scoping review",
keywords="mobile health",
keywords="health insurance",
keywords="electronic database",
keywords="health database",
keywords="mHealth app",
abstract="Background: The use of mobile health (mHealth) apps is increasing rapidly worldwide. More and more institutions and organizations develop regulations and guidelines to enable an evidence-based and safe use. In Germany, mHealth apps fulfilling predefined criteria (Digitale Gesundheitsanwendungen [DiGA]) can be prescribed and are reimbursable by the German statutory health insurance scheme. Due to the increasing distribution of DiGA, problems and barriers should receive special attention. Objective: This study aims to identify the relevant problems and barriers related to the use of mHealth apps fulfilling the criteria of DiGA. Methods: This scoping review will follow published methodological frameworks and the PRISMA-Scr (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews) criteria. Electronic databases (MEDLINE, EMBASE, PsycINFO, and JMIR), reference lists of relevant articles, and grey literature sources will be searched. Two reviewers will assess the eligibility of the articles by a two-stage (title and abstract as well as full text) screening process. Only problems and barriers related to mHealth apps fulfilling the criteria of DiGA are included for this research. The identified studies will be categorized and analyzed with MAXQDA. Results: This scoping review gives an overview of the available evidence and identifies research gaps regarding problems and barriers related to DiGA. The results are planned to be submitted to an indexed, peer-reviewed journal in the first quarter of 2022. Conclusions: This is the first review to identify the problems and barriers related to the use of mHealth apps fulfilling the German definition of DiGA. Nevertheless, the findings can be applied to other contexts and health care systems as well. International Registered Report Identifier (IRRID): DERR1-10.2196/32702 ",
doi="10.2196/32702",
url="https://www.researchprotocols.org/2022/4/e32702",
url="http://www.ncbi.nlm.nih.gov/pubmed/35451979"
}


@Article{info:doi/10.2196/26987,
author="Roy, Alexandra
and Hoge, A. Elizabeth
and Abrante, Pablo
and Druker, Susan
and Liu, Tao
and Brewer, A. Judson",
title="Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2021",
month="Dec",
day="2",
volume="23",
number="12",
pages="e26987",
keywords="anxiety",
keywords="generalized anxiety disorder",
keywords="worry",
keywords="mindfulness",
keywords="mHealth",
keywords="digital therapeutics",
keywords="mobile phone",
abstract="Background: Current treatments for generalized anxiety disorder (GAD) often yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (eg, avoidance reinforcement learning). Mindfulness training (MT) has shown efficacy for anxiety; yet, widespread adoption has been limited, partly because of the difficulty in scaling in-person--based delivery. Digital therapeutics are emerging as potentially viable treatments; however, very few have been empirically validated. Objective: The aim of this study is to test the efficacy and mechanism of an app-delivered MT that was designed to target a potential mechanism of anxiety (reinforcement learning), based on which previous studies have shown concern regarding feedback and the perpetuation of anxiety through negative reinforcement. Methods: Individuals with GAD were recruited using social media advertisements and randomized during an in-person visit to receive treatment as usual (n=33) or treatment as usual+app?delivered MT (Unwinding Anxiety; n=32). The latter was composed of 30 modules to be completed over a 2-month period. Associated changes in outcomes were assessed using self-report questionnaires 1 and 2 months after treatment initiation. Results: We randomized 65 participants in this study, and a modified intent-to-treat approach was used for analysis. The median number of modules completed by the MT group was 25.5 (IQR 17) out of 30; 46\% (13/28) of the participants completed the program. In addition, the MT group demonstrated a significant reduction in anxiety (GAD-7) compared with the control group at 2 months (67\% vs 14\%; median change in GAD-7: --8.5 [IQR 6.5] vs --1.0 [IQR 5.0]; P<.001; 95\% CI 6-10). Increases in mindfulness at 1 month (nonreactivity subscale) mediated decreases in worry at 2 months (Penn State Worry Questionnaire; P=.02) and decreases in worry at 1 month mediated reductions in anxiety at 2 months (P=.03). Conclusions: To our knowledge, this is the first report on the efficacy and mechanism of an app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT as a digital therapeutic for individuals with anxiety (number needed to treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways, resulting in tangible, clinically meaningful reductions in worry and anxiety. Evidence-based, mechanistically targeted digital therapeutics have the potential to improve health at a population level at a low cost. Trial Registration: ClinicalTrials.gov NCT03683472; https://clinicaltrials.gov/ct2/show/NCT03683472 ",
doi="10.2196/26987",
url="https://www.jmir.org/2021/12/e26987",
url="http://www.ncbi.nlm.nih.gov/pubmed/34860673"
}


@Article{info:doi/10.2196/15433,
author="Muro-Culebras, Antonio
and Escriche-Escuder, Adrian
and Martin-Martin, Jaime
and Rold{\'a}n-Jim{\'e}nez, Cristina
and De-Torres, Irene
and Ruiz-Mu{\~n}oz, Maria
and Gonzalez-Sanchez, Manuel
and Mayoral-Cleries, Fermin
and Bir{\'o}, Attila
and Tang, Wen
and Nikolova, Borjanka
and Salvatore, Alfredo
and Cuesta-Vargas, Ignacio Antonio",
title="Tools for Evaluating the Content, Efficacy, and Usability of Mobile Health Apps According to the Consensus-Based Standards for the Selection of Health Measurement Instruments: Systematic Review",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Dec",
day="1",
volume="9",
number="12",
pages="e15433",
keywords="mobile health",
keywords="mHealth",
keywords="eHealth",
keywords="mobile apps",
keywords="assessment",
keywords="rating",
keywords="smartphone",
keywords="questionnaire design",
keywords="mobile phone",
abstract="Background: There are several mobile health (mHealth) apps in mobile app stores. These apps enter the business-to-customer market with limited controls. Both, apps that users use autonomously and those designed to be recommended by practitioners require an end-user validation to minimize the risk of using apps that are ineffective or harmful. Prior studies have reviewed the most relevant aspects in a tool designed for assessing mHealth app quality, and different options have been developed for this purpose. However, the psychometric properties of the mHealth quality measurement tools, that is, the validity and reliability of the tools for their purpose, also need to be studied. The Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) initiative has developed tools for selecting the most suitable measurement instrument for health outcomes, and one of the main fields of study was their psychometric properties. Objective: This study aims to address and psychometrically analyze, following the COSMIN guideline, the quality of the tools that are used to measure the quality of mHealth apps. Methods: From February 1, 2019, to December 31, 2019, 2 reviewers searched PubMed and Embase databases, identifying mHealth app quality measurement tools and all the validation studies associated with each of them. For inclusion, the studies had to be meant to validate a tool designed to assess mHealth apps. Studies that used these tools for the assessment of mHealth apps but did not include any psychometric validation were excluded. The measurement tools were analyzed according to the 10 psychometric properties described in the COSMIN guideline. The dimensions and items analyzed in each tool were also analyzed. Results: The initial search showed 3372 articles. Only 10 finally met the inclusion criteria and were chosen for analysis in this review, analyzing 8 measurement tools. Of these tools, 4 validated ?5 psychometric properties defined in the COSMIN guideline. Although some of the tools only measure the usability dimension, other tools provide information such as engagement, esthetics, or functionality. Furthermore, 2 measurement tools, Mobile App Rating Scale and mHealth Apps Usability Questionnaire, have a user version, as well as a professional version. Conclusions: The Health Information Technology Usability Evaluation Scale and the Measurement Scales for Perceived Usefulness and Perceived Ease of Use were the most validated tools, but they were very focused on usability. The Mobile App Rating Scale showed a moderate number of validated psychometric properties, measures a significant number of quality dimensions, and has been validated in a large number of mHealth apps, and its use is widespread. It is suggested that the continuation of the validation of this tool in other psychometric properties could provide an appropriate option for evaluating the quality of mHealth apps. ",
doi="10.2196/15433",
url="https://mhealth.jmir.org/2021/12/e15433",
url="http://www.ncbi.nlm.nih.gov/pubmed/34855618"
}


@Article{info:doi/10.2196/33012,
author="Dahlhausen, Florian
and Zinner, Maximillian
and Bieske, Linn
and Ehlers, P. Jan
and Boehme, Philip
and Fehring, Leonard",
title="Physicians' Attitudes Toward Prescribable mHealth Apps and Implications for Adoption in Germany: Mixed Methods Study",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Nov",
day="23",
volume="9",
number="11",
pages="e33012",
keywords="mobile health",
keywords="mHealth",
keywords="digital health",
keywords="apps",
keywords="physicians",
keywords="general practitioners",
keywords="technology acceptance",
keywords="adoption",
abstract="Background: In October 2020, Germany became the first country, worldwide, to approve certain mobile health (mHealth) apps, referred to as DiGA (Digitale Gesundheitsanwendungen, in German, meaning digital health applications), for prescription with costs covered by standard statutory health insurance. Yet, this option has only been used to a limited extent so far. Objective: The aim of this study was to investigate physicians' and psychotherapists' current attitudes toward mHealth apps, barriers to adoption, and potential remedies. Methods: We conducted a two-stage sequential mixed methods study. In phase one, semistructured interviews were conducted with physicians and psychotherapists for questionnaire design. In phase two, an online survey was conducted among general practitioners, physicians, and psychotherapists. Results: A total of 1308 survey responses by mostly outpatient-care general practitioners, physicians, and psychotherapists from across Germany who could prescribe DiGA were recorded, making this the largest study on mHealth prescriptions to date. A total of 62.1\% (807/1299) of respondents supported the opportunity to prescribe DiGA. Improved adherence (997/1294, 77.0\%), health literacy (842/1294, 65.1\%), and disease management (783/1294, 60.5\%) were most frequently seen as benefits of DiGA. However, only 30.3\% (393/1299) of respondents planned to prescribe DiGA, varying greatly by medical specialty. Professionals are still facing substantial barriers, such as insufficient information (1135/1295, 87.6\%), reimbursement for DiGA-related medical services (716/1299, 55.1\%), medical evidence (712/1298, 54.9\%), legal uncertainties (680/1299, 52.3\%), and technological uncertainties (658/1299, 50.7\%). To support professionals who are unsure of prescribing DiGA, extended information campaigns (1104/1297, 85.1\%) as well as recommendations from medical associations (1041/1297, 80.3\%) and medical colleagues (1024/1297, 79.0\%) were seen as the most impactful remedies. Conclusions: To realize the benefits from DiGA through increased adoption, additional information sharing about DiGA from trusted bodies, reimbursement for DiGA-related medical services, and further medical evidence are recommended. ",
doi="10.2196/33012",
url="https://mhealth.jmir.org/2021/11/e33012",
url="http://www.ncbi.nlm.nih.gov/pubmed/34817385"
}


@Article{info:doi/10.2196/27995,
author="Mu{\~n}oz-Mancisidor, Aranzazu
and Martin-Payo, Ruben
and Gonzalez-Mendez, Xana
and Fern{\'a}ndez-{\'A}lvarez, Mar Mar{\'i}a Del",
title="Content, Behavior Change Techniques, and Quality of Pregnancy Apps in Spain: Systematic Search on App Stores",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Nov",
day="17",
volume="9",
number="11",
pages="e27995",
keywords="pregnancy",
keywords="mobile apps",
keywords="behavior",
keywords="technology assessment, biomedical",
keywords="telemedicine",
abstract="Background: Women consult information in mobile apps (apps) during pregnancy, and even obstetrics specialists highlight that pregnancy is the ideal moment for the use of apps as consultation sources. However, the high number of apps designed for pregnancy requires a careful assessment to determine their suitability before recommendation. Objective: The aim of this study is to identify the apps available in Spanish that can be recommended based on their content, behavior change techniques (BCTs), and quality as a complementary tool during pregnancy. Methods: A systematic search on app stores to identify apps was performed in the Apple App Store and Google Play with the subject term ``pregnancy.'' The apps meeting the following criteria were chosen: pregnancy-related content, free, and available in Spanish. An app was excluded if it was classified as a game or entertainment and thus lacking an educational or health aim and if it did not target the population under study. The selected apps were downloaded, and their quality was assessed using the Mobile Application Rating Scale (MARS), with the BCTs included evaluated using the BCT taxonomy version 1 and its content. Results: A total of 457 apps were identified, 25 of which were downloaded for assessment (5.6\%). The median for objective and subjective quality was 2.94 (IQR 2.71-3.46) and 1.75 (IQR 1.25-2.25), respectively. Regarding content, the median of topics included in the apps was 23 (IQR 16-23), with weight gain, nutrition, fetal development, and physical activity being the most common. The median number of BCTs was 12 (IQR 0.5-3.5). The most frequently identified BCTs in the apps were ``Self-Monitoring of Outcomes,'' followed by ``Goal Behavior'' and ``Instructions.'' Statistically significant correlations were observed between objective quality and content ($\rho$=0.624; P=.001), subjective quality and content ($\rho$=0.638; P=.001), objective quality and BCTs ($\rho$=0.672; P<.001), subjective quality and BCTs ($\rho$=0.623; P<.001), and BCTs and content ($\rho$=0.580; P=.002). Conclusions: The results of this study suggest that only a small percentage of free pregnancy apps available in Spanish should be recommended. The apps with the best MARS scores were those that addressed a higher number of topics and included a higher number of BCTs. Those with the best content and quality, and a higher number of BCTs included could be recommended by health professionals. ",
doi="10.2196/27995",
url="https://mhealth.jmir.org/2021/11/e27995",
url="http://www.ncbi.nlm.nih.gov/pubmed/34787587"
}


@Article{info:doi/10.2196/25453,
author="Jain, Deeptee
and Norman, Kevin
and Werner, Zachary
and Makovoz, Bar
and Baker, Turner
and Huber, Stephan",
title="Using Postmarket Surveillance to Assess Safety-Related Events in a Digital Rehabilitation App (Kaia App): Observational Study",
journal="JMIR Hum Factors",
year="2021",
month="Nov",
day="9",
volume="8",
number="4",
pages="e25453",
keywords="lower back pain",
keywords="digital therapeutics",
keywords="adverse event",
keywords="pain",
keywords="safety",
keywords="digital health",
keywords="multidisciplinary pain treatment",
abstract="Background: Low back pain (LBP) affects nearly 4 out of 5 individuals during their lifetime and is the leading cause of disability globally. Digital therapeutics are emerging as effective treatment options for individuals experiencing LBP. Despite the growth of evidence demonstrating the benefits of these therapeutics in reducing LBP and improving functional outcomes, little data has been systematically collected on their safety profiles. Objective: This study aims to evaluate the safety profile of a multidisciplinary digital therapeutic for LBP, the Kaia App, by performing a comprehensive assessment of reported adverse events (AEs) by users as captured by a standardized process for postmarket surveillance. Methods: All users of a multidisciplinary digital app that includes physiotherapy, mindfulness techniques, and education for LBP (Kaia App) from 2018 to 2019 were included. Relevant messages sent by users via the app were collected according to a standard operating procedure regulating postmarket surveillance of the device. These messages were then analyzed to determine if they described an adverse event (AE). Messages describing an AE were then categorized based on the type of AE, its seriousness, and its relatedness to the app, and they were described by numerical counts. User demographics, including age and gender, and data on app use were collected and evaluated to determine if they were risk factors for increased AE reporting. Results: Of the 138,337 active users of the Kaia App, 125 (0.09\%) reported at least one AE. Users reported 0.00014 AEs per active day on the app. The most common nonserious AE reported was increased pain. Other nonserious AEs reported included muscle issues, unpleasant sensations, headache, dizziness, and sleep disturbances. One serious AE, a surgery, was reported. Details of the event and its connection to the intervention were not obtainable, as the user did not provide more information when asked to do so; therefore, it was considered to be possibly related to the intervention. There was no relationship between gender and AE reporting (P>.99). Users aged 25 to 34 years had reduced odds (odds ratio [OR] 0.31, 95\% CI 0.08-0.95; P=.03) of reporting AEs, while users aged 55 to 65 years (OR 2.53, 95\% CI 1.36-4.84, P=.002) and ?75 years (OR 4.36, 95\% CI 1.07-13.26; P=.02) had increased odds. AEs were most frequently reported by users who had 0 to 99 active days on the app, and less frequently reported by users with more active days on the app. Conclusions: This study on the Kaia App provides the first comprehensive assessment of reported AEs associated with real-world use of digital therapeutics for lower back pain. The overall rate of reported AEs was very low, but significant reporting bias is likely to be present. The AEs reported were generally consistent with those described for in-person therapies for LBP. ",
doi="10.2196/25453",
url="https://humanfactors.jmir.org/2021/4/e25453",
url="http://www.ncbi.nlm.nih.gov/pubmed/34751664"
}


@Article{info:doi/10.2196/31173,
author="Meyer, Bj{\"o}rn
and Utter, Geri-Lynn
and Hillman, Catherine",
title="A Personalized, Interactive, Cognitive Behavioral Therapy--Based Digital Therapeutic (MODIA) for Adjunctive Treatment of Opioid Use Disorder: Development Study",
journal="JMIR Ment Health",
year="2021",
month="Oct",
day="8",
volume="8",
number="10",
pages="e31173",
keywords="MODIA",
keywords="opioid use disorder",
keywords="digital therapeutic",
keywords="cognitive behavioral therapy",
keywords="medication-assisted treatment",
keywords="Broca",
abstract="Background: Opioid use disorder (OUD) is characterized by the inability to control opioid use despite attempts to stop use and negative consequences to oneself and others. The burden of opioid misuse and OUD is a national crisis in the United States with substantial public health, social, and economic implications. Although medication-assisted treatment (MAT) has demonstrated efficacy in the management of OUD, access to effective counseling and psychosocial support is a limiting factor and a significant problem for many patients and physicians. Digital therapeutics are an innovative class of interventions that help prevent, manage, or treat diseases by delivering therapy using software programs. These applications can circumvent barriers to uptake, improve treatment adherence, and enable broad delivery of evidence-based management strategies to meet service gaps. However, few digital therapeutics specifically targeting OUD are available, and additional options are needed. Objective: To this end, we describe the development of the novel digital therapeutic MODIA. Methods: MODIA was developed by an international, multidisciplinary team that aims to provide effective, accessible, and sustainable management for patients with OUD. Although MODIA is aligned with principles of cognitive behavioral therapy, it was not designed to present any 1 specific treatment and uses a broad range of evidence-based behavior change techniques drawn from cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and motivational interviewing. Results: MODIA uses proprietary software that dynamically tailors content to the users' responses. The MODIA program comprises 24 modules or ``chats'' that patients are instructed to work through independently. Patient responses dictate subsequent content, creating a ``simulated dialogue'' experience between the patient and program. MODIA also includes brief motivational text messages that are sent regularly to prompt patients to use the program and help them transfer therapeutic techniques into their daily routines. Thus, MODIA offers individuals with OUD a custom-tailored, interactive digital psychotherapy intervention that maximizes the personal relevance and emotional impact of the interaction. Conclusions: As part of a clinician-supervised MAT program, MODIA will allow more patients to begin psychotherapy concurrently with opioid maintenance treatment. We expect access to MODIA will improve the OUD management experience and provide sustainable positive outcomes for patients. ",
doi="10.2196/31173",
url="https://mental.jmir.org/2021/10/e31173",
url="http://www.ncbi.nlm.nih.gov/pubmed/34623309"
}


@Article{info:doi/10.2196/28538,
author="Silfee, Valerie
and Williams, Kelly
and Leber, Brett
and Kogan, Jane
and Nikolajski, Cara
and Szigethy, Eva
and Serio, Catherine",
title="Health Care Provider Perspectives on the Use of a Digital Behavioral Health App to Support Patients: Qualitative Study",
journal="JMIR Form Res",
year="2021",
month="Sep",
day="28",
volume="5",
number="9",
pages="e28538",
keywords="digital health",
keywords="mHealth",
keywords="implementation",
keywords="cognitive behavioral therapy",
keywords="anxiety",
keywords="depression",
keywords="smartphone",
keywords="mobile phone",
abstract="Background: Despite the growing evidence indicating the efficacy of digital cognitive behavioral interventions (dCBIs) for behavioral health (BH) treatment, broad and consistent use of such interventions has been limited by knowledge obtained in real-world settings, including factors that impact provider uptake/referral. Engaging providers early in the implementation process offers an opportunity to explore their needs and behaviors, integrate interventions into workflows, and better understand provider setting capabilities. Objective: This study assessed providers' views on the feasibility and acceptability of delivering a cognitive behavioral therapy (CBT)-based mobile app in multiple care settings. Methods: Participating providers included BH and physical health (PH) providers from a women's health center, an outpatient BH clinic, and both rural/urban primary care settings. All participating providers cocreated workflows through facilitated workshops, including establishing feedback loops between the project team and providers and identifying clinical champions at each site. Over a 12-week period, the providers referred adult patients experiencing anxiety or depression to a mobile app-based dCBI, RxWell, and provided other indicated treatments as part of usual care. Referrals were completed by the providers through the electronic medical record. To better understand facilitators of and challenges in integrating RxWell into routine practice and perceptions of sustainability, a series of qualitative interviews was conducted. Interview data were analyzed to identify major themes using an inductive content analysis approach. Results: A total of 19 provider interviews were conducted to discover motivators and barriers for referring RxWell. The providers benefited from a focused discussion on how to incorporate the referral process into their workflow, and knowing the app content was rooted in evidence. Although the providers believed engaging in experiential learning was important, they indicated that more education on the digital health coach role and how to monitor patient progress is needed. The providers thought patient engagement may be impacted by motivation, a lack of comfort using a smartphone, or preference for in-person therapy. The providers also expressed enthusiasm in continuing to refer the app. They liked the ability to provide patients with support between sessions, to have an extra treatment option that teaches BH exercises, and to have a CBT treatment option that overcomes barriers (eg, wait times, copays, travel) to traditional therapy modalities. Conclusions: Digital intervention success in health care settings relies heavily on engagement of key stakeholders, such as providers, in both design and implementation of the intervention and focused evaluation within intended care setting(s). Scaling digital interventions to meet the mental health needs of patients in usual care settings leans on thoughtfully constructed and streamlined workflows to enable seamless referral of patients by providers. Our findings strongly suggest that providers are supportive of digital tool integration to support the mental health of patients and endorse its use within their routine workflow. ",
doi="10.2196/28538",
url="https://formative.jmir.org/2021/9/e28538",
url="http://www.ncbi.nlm.nih.gov/pubmed/34529583"
}


@Article{info:doi/10.2196/25751,
author="Summers, Charlotte
and Tobin, Simon
and Unwin, David",
title="Evaluation of the Low Carb Program Digital Intervention for the Self-Management of Type 2 Diabetes and Prediabetes in an NHS England General Practice: Single-Arm Prospective Study",
journal="JMIR Diabetes",
year="2021",
month="Sep",
day="9",
volume="6",
number="3",
pages="e25751",
keywords="Low Carb Program",
keywords="low carbohydrate",
keywords="diabetes",
keywords="type 2 diabetes intervention",
keywords="diabetes prevention",
keywords="self-management",
keywords="behavior change",
keywords="prediabetes",
abstract="Background: Type 2 diabetes mellitus has serious health consequences, including blindness, amputation, and stroke. Researchers and clinicians are increasingly in agreement that type 2 diabetes may be effectively treated with a carbohydrate-reduced diet. Digital apps are increasingly used as an adjunct to traditional health care provisions to support remote self-management of long-term health conditions. Objective: Our objective was to evaluate the real-world 12-month outcomes of patients prescribed the Low Carb Program digital health intervention at a primary care National Health Service (NHS) site. The Low Carb Program is a nutritionally focused, 12-session, digitally delivered, educational behavior change intervention for glycemic control and weight loss for adults with prediabetes and type 2 diabetes. The program educates and supports sustainable dietary changes focused on carbohydrate restriction by utilizing behavior change techniques, including goal setting, peer support, and behavioral self-monitoring, as well as personalized downloadable resources, including recipes and meal plans tailored to ethnicity, weekly shopping budget, and dietary preferences. Methods: This study evaluated the real-world outcomes of patients recruited to the Low Carb Program at an NHS general practice in Southport, United Kingdom. All of the NHS patients recruited to the program were diagnosed with type 2 diabetes or prediabetes and were given access to the program at no cost. A total of 45 participants, with a mean age of 54.8 years (SD 13.2), were included in the study. Women made up 42\% (19/45) of the sample. The mean hemoglobin A1c (HbA1c) of the sample was 56.7 mmol/mol (SD 16.95) and the mean body weight was 89.4 kg (SD 13.8). Results: Of the 45 study participants recruited to the program, all of them (100\%) activated their accounts and 37 (82\%) individuals reported outcomes at 12 months. All 45 (100\%) patients completed at least 40\% of the lessons and 32 (71\%) individuals completed more than nine out of 12 core lessons of the program. Glycemic control and weight loss improved, particularly for participants who completed more than nine core lessons in the program over 12 months. The mean HbA1c went from 58.8 mmol/mol at baseline to 54.0 mmol/mol, representing a mean reduction of 4.78 mmol/mol (SD 4.60; t31=5.87; P<.001). Results showed an average total body weight reduction of 4.17\%, with an average weight reduction of 3.85 kg (SD 2.49; t31=9.27; P<.001) at the 12-month follow-up point. Conclusions: A digital app prescribed to adults with type 2 diabetes and prediabetes in a primary care setting supporting a transition to a low-carbohydrate diet has been shown to be effective in improving glycemic control and enabling weight loss. Further research to understand more about factors affecting engagement with the app and further positive health implications would be valuable. ",
doi="10.2196/25751",
url="https://diabetes.jmir.org/2021/3/e25751",
url="http://www.ncbi.nlm.nih.gov/pubmed/34499035"
}


@Article{info:doi/10.2196/24633,
author="Karakoyun, Toeresin
and Podhaisky, Hans-Peter
and Frenz, Ann-Kathrin
and Schuhmann-Giampieri, Gabriele
and Ushikusa, Thais
and Schr{\"o}der, Daniel
and Zvolanek, Michal
and Lopes Da Silva Filho, Agnaldo",
title="Digital Medical Device Companion (MyIUS) for New Users of Intrauterine Systems: App Development Study",
journal="JMIR Med Inform",
year="2021",
month="Jul",
day="13",
volume="9",
number="7",
pages="e24633",
keywords="medical device",
keywords="levonorgestrel-releasing intrauterine system",
keywords="mobile medical app",
keywords="mobile phone",
abstract="Background: Women choosing a levonorgestrel-releasing intrauterine system may experience changes in their menstrual bleeding pattern during the first months following placement. Objective: Although health care professionals (HCPs) can provide counseling, no method of providing individualized information on the expected bleeding pattern or continued support is currently available for women experiencing postplacement bleeding changes. We aim to develop a mobile phone--based medical app (MyIUS) to meet this need and provide a digital companion to women after the placement of the intrauterine system. Methods: The MyIUS app is classified as a medical device and uses an artificial intelligence--based bleeding pattern prediction algorithm to estimate a woman's future bleeding pattern in terms of intensity and regularity. We developed the app with the help of a multidisciplinary team by using a robust and high-quality design process in the context of a constantly evolving regulatory landscape. The development framework consisted of a phased approach including ideation, feasibility and concept finalization, product development, and product deployment or localization stages. Results: The MyIUS app was considered useful by HCPs and easy to use by women who were consulted during the development process. Following the launch of the sustainable app in selected pilot countries, performance metrics will be gathered to facilitate further technical and feature updates and enhancements. A real-world performance study will also be conducted to allow us to upgrade the app in accordance with the new European Commission Medical Device legislation and to validate the bleeding pattern prediction algorithm in a real-world setting. Conclusions: By providing a meaningful estimation of bleeding patterns and allowing an individualized approach to counseling and discussions about contraceptive method choice, the MyIUS app offers a useful tool that may benefit both women and HCPs. Further work is needed to validate the performance of the prediction algorithm and MyIUS app in a real-world setting. ",
doi="10.2196/24633",
url="https://medinform.jmir.org/2021/7/e24633",
url="http://www.ncbi.nlm.nih.gov/pubmed/34255688"
}


@Article{info:doi/10.2196/26152,
author="Hunt, Melissa
and Miguez, Sofia
and Dukas, Benji
and Onwude, Obinna
and White, Sarah",
title="Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial",
journal="JMIR Mhealth Uhealth",
year="2021",
month="May",
day="20",
volume="9",
number="5",
pages="e26152",
keywords="digital health",
keywords="irritable bowel syndrome",
keywords="cognitive behavioral therapy",
keywords="CBT",
keywords="efficacy",
keywords="mHealth",
keywords="self-management",
keywords="IBS",
keywords="randomized controlled trial",
keywords="app",
abstract="Background: Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety, which can result in reduced productivity and impaired health-related quality of life (HRQL). Cognitive behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have potential to increase access to guided CBT at scale, but require careful study to assess their benefits and risks. Objective: The aim of this study was to test the efficacy of a novel app, Zemedy, as a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. Methods: This was a crossover randomized controlled trial. Participants were recruited online and randomly allocated to either immediate treatment (n=62) or waitlist control (n=59) groups. The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy, behavioral experiments, and information about diet.  Users interact with a chatbot that presents the information and encourages specific plans, homework, and exercises. The treatment was fully automated, with no therapist involvement or communication.  At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life [IBS-QOL], Gastrointestinal Symptom Rating Scale [GSRS]) and secondary (Fear of Food Questionnaire [FFQ], Visceral Sensitivity Index [VSI], Gastrointestinal Cognition Questionnaire [GI-COG], Depression Anxiety Stress Scale [DASS], and Patient Health Questionnaire-9 [PHQ-9]) outcome measures. Waitlist controls were then offered the opportunity to crossover to treatment. All participants were assessed once more at 3 months posttreatment. Results: Both intention-to-treat and completer analyses at posttreatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months posttreatment. Scores on the GSRS, IBS-QoL, GI-COG, VSI, and FFQ all improved significantly more in the treatment group (F1,79=20.49, P<.001, Cohen d=1.01; F1,79=20.12, P<.001, d=1.25; F1,79=34.71, P<.001, d=1.47; F1,79=18.7, P<.001, d=1.07; and F1,79=12.13, P=.001, d=0.62, respectively). Depression improved significantly as measured by the PHQ-9 (F1,79=10.5, P=.002, d=1.07), and the DASS Depression (F1,79=6.03, P=.02, d=.83) and Stress (F1,79=4.47, P=.04, d=0.65) subscales in the completer analysis but not in the intention-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. Conclusions: Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence-based treatment. Trial Registration: ClinicalTrials.gov NCT04170686; https://www.clinicaltrials.gov/ct2/show/NCT04170686 ",
doi="10.2196/26152",
url="https://mhealth.jmir.org/2021/5/e26152",
url="http://www.ncbi.nlm.nih.gov/pubmed/33872182"
}


@Article{info:doi/10.2196/25401,
author="Sinha, Ranjan
and Kachru, Dashyanng
and Ricchetti, Ray Roshni
and Singh-Rambiritch, Simitha
and Muthukumar, Marimuthu Karthik
and Singaravel, Vidhya
and Irudayanathan, Carmel
and Reddy-Sinha, Chandana
and Junaid, Imran
and Sharma, Garima
and Francis-Lyon, Alice Patricia",
title="Leveraging Genomic Associations in Precision Digital Care for Weight Loss: Cohort Study",
journal="J Med Internet Res",
year="2021",
month="May",
day="19",
volume="23",
number="5",
pages="e25401",
keywords="obesity",
keywords="digital therapeutics",
keywords="precision nutrition",
keywords="nutrigenomics",
keywords="personalized nutrition",
keywords="mHealth",
keywords="mobile apps",
keywords="gut microbiota",
keywords="machine learning",
keywords="health coaching",
keywords="lifestyle medicine",
keywords="mobile phone",
abstract="Background: The COVID-19 pandemic has highlighted the urgency of addressing an epidemic of obesity and associated inflammatory illnesses. Previous studies have demonstrated that interactions between single-nucleotide polymorphisms (SNPs) and lifestyle interventions such as food and exercise may vary metabolic outcomes, contributing to obesity. However, there is a paucity of research relating outcomes from digital therapeutics to the inclusion of genetic data in care interventions. Objective: This study aims to describe and model the weight loss of participants enrolled in a precision digital weight loss program informed by the machine learning analysis of their data, including genomic data. It was hypothesized that weight loss models would exhibit a better fit when incorporating genomic data versus demographic and engagement variables alone. Methods: A cohort of 393 participants enrolled in Digbi Health's personalized digital care program for 120 days was analyzed retrospectively. The care protocol used participant data to inform precision coaching by mobile app and personal coach. Linear regression models were fit of weight loss (pounds lost and percentage lost) as a function of demographic and behavioral engagement variables. Genomic-enhanced models were built by adding 197 SNPs from participant genomic data as predictors and refitted using Lasso regression on SNPs for variable selection. Success or failure logistic regression models were also fit with and without genomic data. Results: Overall, 72.0\% (n=283) of the 393 participants in this cohort lost weight, whereas 17.3\% (n=68) maintained stable weight. A total of 142 participants lost 5\% bodyweight within 120 days. Models described the impact of demographic and clinical factors, behavioral engagement, and genomic risk on weight loss. Incorporating genomic predictors improved the mean squared error of weight loss models (pounds lost and percent) from 70 to 60 and 16 to 13, respectively. The logistic model improved the pseudo R2 value from 0.193 to 0.285. Gender, engagement, and specific SNPs were significantly associated with weight loss. SNPs within genes involved in metabolic pathways processing food and regulating fat storage were associated with weight loss in this cohort: rs17300539\_G (insulin resistance and monounsaturated fat metabolism), rs2016520\_C (BMI, waist circumference, and cholesterol metabolism), and rs4074995\_A (calcium-potassium transport and serum calcium levels). The models described greater average weight loss for participants with more risk alleles. Notably, coaching for dietary modification was personalized to these genetic risks. Conclusions: Including genomic information when modeling outcomes of a digital precision weight loss program greatly enhanced the model accuracy. Interpretable weight loss models indicated the efficacy of coaching informed by participants' genomic risk, accompanied by active engagement of participants in their own success. Although large-scale validation is needed, our study preliminarily supports precision dietary interventions for weight loss using genetic risk, with digitally delivered recommendations alongside health coaching to improve intervention efficacy. ",
doi="10.2196/25401",
url="https://www.jmir.org/2021/5/e25401",
url="http://www.ncbi.nlm.nih.gov/pubmed/33849843"
}


@Article{info:doi/10.2196/21795,
author="Sarradon-Eck, Aline
and Bouchez, Tiphanie
and Auroy, Lola
and Schuers, Matthieu
and Darmon, David",
title="Attitudes of General Practitioners Toward Prescription of Mobile Health Apps: Qualitative Study",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Mar",
day="4",
volume="9",
number="3",
pages="e21795",
keywords="mobile applications",
keywords="qualitative research",
keywords="general practitioners",
keywords="France",
keywords="mobile phone",
abstract="Background: Mobile health (mHealth) apps are a potential means of empowering patients, especially in the case of multimorbidity, which complicates patients' care needs. Previous studies have shown that general practitioners (GPs) have both expectations and concerns regarding patients' use of mHealth apps that could impact their willingness to recommend the apps to patients. Objective: The aim of this qualitative study is to investigate French GPs' attitudes toward the prescription of mHealth apps or devices aimed toward patients by analyzing GPs' perceptions and expectations of mHealth technologies. Methods: A total of 36 GPs were interviewed individually (n=20) or in a discussion group (n=16). All participants were in private practice. A qualitative analysis of each interview and focus group was conducted using grounded theory analysis. Results: Considering the value assigned to mHealth apps by participants and their willingness or resistance to prescribe them, 3 groups were defined based on the attitudes or positions adopted by GPs: digital engagement (favorable attitude; mHealth apps are perceived as additional resources and complementary tools that facilitate the medical work, the follow-up care, and the monitoring of patients; and apps increase patients' compliance and empowerment); patient protection (related to the management of patient care and fear of risks for patients, concerns about patient data privacy and security, doubt about the usefulness for empowering patients, standardization of the medical decision process, overmedicalization, risks for individual freedom, and increasing social inequalities in health); doctor protection (fear of additional tasks and burden, doubt about the actionability of patient-gathered health data, risk for medical liability, dehumanization of the patient-doctor relationship, fear of increased drug prescription, and commodification of patient data). Conclusions: A deep understanding of both the expectations and fears of GPs is essential to motivate them to recommend mHealth apps to their patients. The results of this study show the need to provide appropriate education and training to enhance GPs' digital skills. Certification of the apps by an independent authority should be encouraged to reassure physicians about ethical and data security issues. Our results highlight the need to overcome technical issues such as interoperability between data collection and medical records to limit the disruption of medical work because of data flow. ",
doi="10.2196/21795",
url="https://mhealth.jmir.org/2021/3/e21795",
url="http://www.ncbi.nlm.nih.gov/pubmed/33661123"
}


@Article{info:doi/10.2196/17447,
author="Byambasuren, Oyungerel
and Beller, Elaine
and Hoffmann, Tammy
and Glasziou, Paul",
title="Barriers to and Facilitators of the Prescription of mHealth Apps in Australian General Practice: Qualitative Study",
journal="JMIR Mhealth Uhealth",
year="2020",
month="Jul",
day="30",
volume="8",
number="7",
pages="e17447",
keywords="mobile apps",
keywords="mHealth",
keywords="apps",
keywords="app prescription",
keywords="general practice",
abstract="Background: The ubiquity of smartphones and health apps make them a potential self-management tool for patients that could be prescribed by medical professionals. However, little is known about how Australian general practitioners and their patients view the possibility of prescribing mobile health (mHealth) apps as a nondrug intervention. Objective: This study aimed to determine barriers and facilitators to prescribing mHealth apps in Australian general practice from the perspective of general practitioners and their patients. Methods: We conducted semistructured interviews in Australian general practice settings with purposively sampled general practitioners and patients. The audio-recorded interviews were transcribed, coded, and thematically analyzed by two researchers. Results: Interview participants included 20 general practitioners and 15 adult patients. General practitioners' perceived barriers to prescribing apps included a generational difference in the digital propensity for providers and patients; lack of knowledge of prescribable apps and trustworthy sources to access them; the time commitment required of providers and patients to learn and use the apps; and concerns about privacy, safety, and trustworthiness of health apps. General practitioners perceived facilitators as trustworthy sources to access prescribable apps and information, and younger generation and widespread smartphone ownership. For patients, the main barriers were older age and usability of mHealth apps. Patients were not concerned about privacy and data safety issues regarding health app use. Facilitators for patients included the ubiquity of smartphones and apps, especially for the younger generation and recommendation of apps by doctors. We identified evidence of effectiveness as an independent theme from both the provider and patient perspectives. Conclusions: mHealth app prescription appears to be feasible in general practice. The barriers and facilitators identified by the providers and patients overlapped, though privacy was of less concern to patients. The involvement of health professionals and patients is vital for the successful integration of effective, evidence-based mHealth apps with clinical practice. ",
doi="10.2196/17447",
url="http://mhealth.jmir.org/2020/7/e17447/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32729839"
}


@Article{info:doi/10.2196/16497,
author="Byambasuren, Oyungerel
and Beller, Elaine
and Hoffmann, Tammy
and Glasziou, Paul",
title="mHealth App Prescription in Australian General Practice: Pre-Post Study",
journal="JMIR Mhealth Uhealth",
year="2020",
month="Jun",
day="1",
volume="8",
number="6",
pages="e16497",
keywords="mHealth apps",
keywords="app prescription",
keywords="general practice",
abstract="Background: Evidence of effectiveness of mobile health (mHealth) apps as well as their usability as non-drug interventions in primary care are emerging around the globe. Objective: This study aimed to explore the feasibility of mHealth app prescription by general practitioners (GPs) and to evaluate the effectiveness of an implementation intervention to increase app prescription. Methods: A single-group, before-and-after study was conducted in Australian general practice. GPs were given prescription pads for 6 mHealth apps and reported the number of prescriptions dispensed for 4 months. After the reporting of month 2, a 2-minute video of one of the apps was randomly selected and sent to each GP. Data were collected through a prestudy questionnaire, monthly electronic reporting, and end-of-study interviews. The primary outcome was the number of app prescriptions (total, monthly, per GP, and per GP per fortnight). Secondary outcomes included confidence in prescribing apps (0-5 scale), the impact of the intervention video on subsequent prescription numbers, and acceptability of the interventions. Results: Of 40 GPs recruited, 39 commenced, and 36 completed the study. In total, 1324 app prescriptions were dispensed over 4 months. The median number of apps prescribed per GP was 30 (range 6-111 apps). The median number of apps prescribed per GP per fortnight increased from the pre-study level of 1.7 to 4.1. Confidence about prescribing apps doubled from a mean of 2 (not so confident) to 4 (very confident). App videos did not affect subsequent prescription rates substantially. Post-study interviews revealed that the intervention was highly acceptable. Conclusions: mHealth app prescription in general practice is feasible, and our implementation intervention was effective in increasing app prescription. GPs need more tailored education and training on the value of mHealth apps and knowledge of prescribable apps to be able to successfully change their prescribing habits to include apps. The future of sustainable and scalable app prescription requires a trustworthy electronic app repository of prescribable mHealth apps for GPs. ",
doi="10.2196/16497",
url="https://mhealth.jmir.org/2020/6/e16497",
url="http://www.ncbi.nlm.nih.gov/pubmed/32478660"
}