JMIR Publications

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  mHealth for Telemedicine and Homecare

  Jul 3, 2020

  Application and Preliminary Outcomes of Remote Diagnosis and Treatment During the COVID-19 Outbreak: Retrospective Cohort Study

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  Authors List:

  • Luwen Liu  
  • Jianqin Gu  
  • Fengmin Shao  
  • Xinliang Liang  
  • Lixia Yue  
  • Qiaomei Cheng  
  • Lianzhong Zhang  

  Abstract:

  Background: The coronavirus disease (COVID-19) pandemic, caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in the self-quarantine of countless people due to possible infection. This situation makes telemedicine necessary as it can overcome geographical barriers, increase the number of people served, and provide online clinical support for patients. However, the outcomes of telemedicine have not yet been evaluated. Objective: The aim of our study is to describe the epidemiological features and clinical symptoms of patients receiving remote diagnosis and treatment at the online outpatient clinic of our hospital, as well as to analyze the outcomes and advantages of telemedicine, during the COVID-19 pandemic. Methods: Data from patients receiving remote diagnosis and treatment via consultation services for COVID-19 concerns at the online outpatient clinic of Henan Provincial People's Hospital from January 24 to February 17, 2020, were collected. A retrospective analysis was performed on epidemiological features, clinical symptoms, and preliminary outcomes. Results: Online inquiry, consultation, and suggestions were provided for patient concerns related to COVID-19. Our hospital also offered offline noncontact drug delivery services following online ordering and payment. A total of 4589 patients receiving remote diagnosis and treatment were recruited. The daily number of online outpatient visits initially increased and then decreased, reaching its peak on January 28 when the daily number of online outpatient visits totaled 612. Of 4589 patients, 1940 (42.3%) were males and 2649 (57.7%) were females (age range: 78 days to 85 years). Most patients were aged 20-39 years (n=3714, 80.9%) and came from Henan Province (n=3898, 84.9%). The number of patients from other provinces was 691 (15.1%). During the online consultations, patients discussed the following symptoms: fever (n=2383), cough (n=1740), nasal obstruction (n=794), fatigue (n=503), and diarrhea (n=276). A total of 873 orders of noncontact drug delivery following online payment was completed. The daily number of such orders gradually stabilized after the initial, steady increase. For offline drug delivery orders, the median (IQR) was 36 (58). An online satisfaction survey was filled out postconsultation by patients; of the 985 responses received, 98.1% (n=966) of respondents were satisfied with the service they received. Conclusions: Remote diagnosis and treatment offered via online outpatient consultations effectively reduced the burden on hospitals, prevented overcrowding, reduced the risk of cross-infection, and relieved patients' anxiety during the COVID-19 outbreak. This plays an essential role in pandemic management.

  • JMIR Mhealth Uhealth 2020;8(7):e19417

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  Fitness Trackers and Smart...

  Jul 3, 2020

  Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial

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  Authors List:

  • Linda C Li  
  • Lynne M Feehan  
  • Hui Xie  
  • Na Lu  
  • Christopher D Shaw  
  • Diane Gromala  
  • Siyi Zhu  
  • J Antonio Aviña-Zubieta  
  • Alison M Hoens  
  • Cheryl Koehn  
  • Johnathan Tam  
  • Stephanie Therrien  
  • Anne F Townsend  
  • Gregory Noonan  
  • Catherine L Backman  

  Abstract:

  Background: Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control. Objective: This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA. Methods: This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index. Results: We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes. Conclusions: A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA. Trial Registration: ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323

  • JMIR Mhealth Uhealth 2020;8(7):e19116

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  mHealth for Wellness, Behavior Change...

  Jul 3, 2020

  Maintaining Physical Activity Level Through Team-Based Walking With a Mobile Health Intervention: Cross-Sectional Observational Study

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  Authors List:

  • Yuri Hamamatsu  
  • Hiroo Ide  
  • Michiru Kakinuma  
  • Yuji Furui  

  Abstract:

  Background: The health conditions of Japanese salespersons may be adversely affected by their lifestyle. Face-to-face or on-site health interventions are not convenient for salespersons because of their tendency for out-of-office sales. Previous studies showed that mobile health (mHealth) interventions (compared to usual practice) have great potential to promote physical activity. For Japanese salespersons, mHealth can offer additional convenience to change their physical activity habits because they can access the mHealth contents anytime and anywhere. However, the specific elements that are most important to maintain physical activity levels using an mHealth approach remain unclear. Objective: We aimed to identify elements that account for both a high average physical activity level and can help to prevent a decrease in physical activity during a 9-week intervention period. Methods: Salespersons were recruited from 11 Japanese companies. A team-based walking intervention was held from October to December 2018 (for a total of 9 weeks), during which the walking step data were recorded by smartphone apps. Average walking steps of each participant during the intervention and the difference in walking steps between the initial and the final week were respectively used as dependent variables. The effects of team characteristics (ie, frequency of communication with team members and team size) and behavioral characteristics (ie, number of days with recorded steps on the apps) on the average walking steps, and the difference in walking steps between the initial and the final week were estimated using multiple and multilevel regression analyses. Results: Of the 416 participants, walking step data of 203 participants who completed postintervention assessments were included in the analyses. Multiple regression analysis of the average walking steps showed that the number of days with recorded steps was positively correlated with the log-transformed average walking steps (β=.01, P<.001). Multilevel analysis of the average walking steps considering the company level estimated that the intraclass correlation coefficient was 37%. This means that belonging to the same company largely affected an individual’s average walking steps. Multiple regression analysis of the difference in walking steps showed that communication with team members once or twice a week correlated with preventing a decrease in walking steps from the initial to the final week (β=1539.4, P=.03), and being on a larger team correlated with a decrease in walking steps from the initial to the final week (β=–328.4, P=.01). Conclusions: This study showed that the elements accounting for high average walking steps and those preventing the decrease in walking steps from the initial to the final week differed. Behavioral characteristics correlated positively with average walking steps. Team characteristics (ie, regular communication and a smaller team size) significantly correlated with preventing a decrease in walking steps.

  • JMIR Mhealth Uhealth 2020;8(7):e16159

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  Security and Privacy of mHealth and...

  Jul 2, 2020

  Privacy Assessment in Mobile Health Apps: Scoping Review

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  Authors List:

  • Jaime Benjumea  
  • Jorge Ropero  
  • Octavio Rivera-Romero  
  • Enrique Dorronzoro-Zubiete  
  • Alejandro Carrasco  

  Abstract:

  Background: Privacy has always been a concern, especially in the health domain. The proliferation of mobile health (mHealth) apps has led to a large amount of sensitive data being generated. Some authors have performed privacy assessments of mHealth apps. They have evaluated diverse privacy components; however, different authors have used different criteria for their assessments. Objective: This scoping review aims to understand how privacy is assessed for mHealth apps, focusing on the components, scales, criteria, and scoring methods used. A simple taxonomy to categorize the privacy assessments of mHealth apps based on component evaluation is also proposed. Methods: We followed the methodology defined by Arksey and O’Malley to conduct a scoping review. Included studies were categorized based on the privacy component, which was assessed using the proposed taxonomy. Results: The database searches retrieved a total of 710 citations—24 of them met the defined selection criteria, and data were extracted from them. Even though the inclusion criteria considered articles published since 2009, all the studies that were ultimately included were published from 2014 onward. Although 12 papers out of 24 (50%) analyzed only privacy, 8 (33%) analyzed both privacy and security. Moreover, 4 papers (17%) analyzed full apps, with privacy being just part of the assessment. The evaluation criteria used by authors were heterogeneous and were based on their experience, the literature, and/or existing legal frameworks. Regarding the set of items used for the assessments, each article defined a different one. Items included app permissions, analysis of the destination, analysis of the content of communications, study of the privacy policy, use of remote storage, and existence of a password to access the app, among many others. Most of the included studies provided a scoring method that enables the comparison of privacy among apps. Conclusions: The privacy assessment of mHealth apps is a complex task, as the criteria used by different authors for their evaluations are very heterogeneous. Although some studies about privacy assessment have been conducted, a very large set of items to evaluate privacy has been used up until now. In-app information and privacy policies are primarily utilized by the scientific community to extract privacy information from mHealth apps. The creation of a scale based on more objective criteria is a desirable step forward for privacy assessment in the future.

  • JMIR Mhealth Uhealth 2020;8(7):e18868

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  mHealth for Symptom and Disease...

  Jun 30, 2020

  A Web-Based Mobile App (INTERACCT App) for Adolescents Undergoing Cancer and Hematopoietic Stem Cell Transplantation Aftercare to Improve the Quality of...

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  Authors List:

  • Anita Lawitschka  
  • Stephanie Buehrer  
  • Dorothea Bauer  
  • Konrad Peters  
  • Marisa Silbernagl  
  • Natalia Zubarovskaya  
  • Barbara Brunmair  
  • Fares Kayali  
  • Helmut Hlavacs  
  • Ruth Mateus-Berr  
  • David Riedl  
  • Gerhard Rumpold  
  • Christina Peters  

  Abstract:

  Background: A growing number of cancer and hematopoietic stem cell transplant (HSCT) survivors require long-term follow-up with optimal communication schemes, and patients' compliance is crucial. Adolescents have various unmet needs. Regarding self-report of symptoms and health status, users of mobile apps showed enhanced compliance. Currently, HSCT aftercare at the HSCT outpatient clinic of the St. Anna Children’s Hospital in Vienna, Austria, is based on handwritten diaries, carrying various disadvantages. Recently, we developed the prototype of a web-based, self-monitoring gamified mobile app tailored for adolescents: the INTERACCT (Integrating Entertainment and Reaction Assessment into Child Cancer Therapy) app. Objective: This observational, prospective study evaluated the usability of the INTERACCT app for tracking real-time self-reported symptoms and health status data in adolescent HSCT patients and a healthy matched control group. The primary outcome of the study was the quality of the self-reported medical information. We hypothesized that the mobile app would provide superior medical information for the clinicians than would the handwritten diaries. Methods: Health data were reported via paper diary and mobile app for 5 consecutive days each. The quality of medical information was rated on a 5-point scale independently and blinded by two HSCT clinicians, and the duration of use was evaluated. A total of 52 participant questionnaires were assessed for gaming patterns and device preferences, self-efficacy, users’ satisfaction, acceptability, and suggestions for improvement of the mobile app. Interrater reliability was calculated with the intraclass correlation coefficient, based on a two-way mixed model; one-way repeated-measures analysis of variance and t tests were conducted post hoc. Descriptive methods were used for correlation with participants’ demographics. For users’ satisfaction and acceptability of the mobile app, the median and the IQR were calculated. Results: Data from 42 participants—15 patients and 27 healthy students—with comparable demographics were evaluated. The results of our study indicated a superiority of the quality of self-reported medical data in the INTERACCT app over traditional paper-and-pencil assessment (mobile app: 4.14 points, vs paper-based diary: 3.77 points, P=.02). The mobile app outperformed paper-and-pencil assessments mainly among the patients, in particular among patients with treatment-associated complications (mobile app: 4.43 points, vs paper-based diary: 3.73 points, P=.01). The mobile app was used significantly longer by adolescents (≥14 years: 4.57 days, vs ≤13 years: 3.14 days, P=.03) and females (4.76 days for females vs 2.95 days for males, P=.004). This corresponds with a longer duration of use among impaired patients with comorbidities. User satisfaction and acceptability ratings for the mobile app were high across all groups, but adherence to entering a large amount of data decreased over time. Based on our results, we developed a case vignette of the target group. Conclusions: Our study was the first to show that the quality of patient-reported medical information submitted via the INTERACCT app embedded in a serious game is superior to that submitted via a handwritten diary. In light of these results, a refinement of the mobile app supported by a machine learning approach is planned within an international research project.

  • JMIR Mhealth Uhealth 2020;8(6):e18781

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  mHealth for Symptom and Disease...

  Jun 29, 2020

  Feasibility and Utility of mHealth for the Remote Monitoring of Parkinson Disease: Ancillary Study of the PD_manager Randomized Controlled Trial

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  Authors List:

  • Dimitris Gatsios  
  • Angelo Antonini  
  • Giovanni Gentile  
  • Andrea Marcante  
  • Clelia Pellicano  
  • Lucia Macchiusi  
  • Francesca Assogna  
  • Gianfranco Spalletta  
  • Heather Gage  
  • Morro Touray  
  • Lada Timotijevic  
  • Charo Hodgkins  
  • Maria Chondrogiorgi  
  • George Rigas  
  • Dimitrios I Fotiadis  
  • Spyridon Konitsiotis  

  Abstract:

  Background: Mobile health, predominantly wearable technology and mobile apps, have been considered in Parkinson disease to provide valuable ecological data between face-to-face visits and improve monitoring of motor symptoms remotely. Objective: We explored the feasibility of using a technology-based mHealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in this study as the PD_manager system, to collect clinically meaningful data. We also explored outcomes and disease-related factors that are important determinants to establish feasibility. Finally, we further validated a tremor evaluation method with data collected while patients performed their daily activities. Methods: PD_manager trial was an open-label parallel group randomized study.The mHealth platform consists of a wristband, a pair of sensor insoles, a smartphone (with dedicated mobile Android apps) and a knowledge platform serving as the cloud backend. Compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson’s Disease Rating Scale estimations by clinicians were explored. Results: Of the 75 study participants, 65 (87%) completed the protocol. They used the PD_manager system for a median 11.57 (SD 3.15) days. Regression analysis suggests that the main factor associated with high use was caregivers’ burden. Motor Aspects of Experiences of Daily Living and patients’ self-rated health status also influence the system’s use. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor. Conclusions: We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11 to 14 days. The study further supports that mHealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mHealth platform can improve disease management and care.

  • JMIR Mhealth Uhealth 2020;8(6):e16414

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  mHealth for Wellness, Behavior Change...

  Jun 29, 2020

  Designing for the Co-Use of Consumer Health Technology in Self-Management of Adolescent Overweight and Obesity: Mixed Methods Qualitative Study

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  Authors List:

  • Cynthia M LeRouge  
  • Hyeyoung Hah  
  • Gloria J Deckard  
  • Haoqiang Jiang  

  Abstract:

  Background: Overweight and obesity in adolescents has reached epidemic proportions in the United States. Consumer health technology (CHT) can serve as a behavioral and social support tool for the management of overweight in adolescence. Recognizing CHT as a social support tool during design enables input from multiple stakeholders who engage in shared co-use to reinforce and empower adolescents in their self-management efforts. Objective: This study aimed to explore design requirements and enabling factors for the use of CHT as a social support tool for patients (as primary users) and parents and health care providers (as co-users). Our model incorporates key components of the unified theory of acceptance and use of technology (UTAUT) within the framework of the obesity care model (OCM) by recognizing patient self-management as the central process with the influence of their care support network on CHT use and outcomes. Methods: This study was part of a larger two-staged usability study combining focus group, semistructured interviews, and usability walkthroughs of CHT mockups from adolescents (BMI in the 85th-99th percentile range), parents, and physicians. In phase 1, 48 adolescents between the ages of 12 and 17 years, 10 of their parents, and 6 health care providers participated in identifying design requirements and enabling factors for the use of a potential CHT. In phase 2, 70 adolescents and 10 health care providers evaluated the CHT mockups and indicated enabling factors and willingness to use the proposed CHT. Results: Our qualitative analysis identified adolescents’ intention for the use of CHT in alignment with UTAUT elements of performance expectancy, effort expectancy, and facilitating conditions. Our reconceptualization of social influence identified the expectations and envisioned roles of parents and health care providers as co-users and influencing factors on the co-use of CHT in managing overweight in adolescence. Parents were expected to monitor, to provide guidance and motivation, and to suggest modifications in daily habits, for example, recipes and meals, whereas health care providers were expected to encourage and monitor progress in a clinical setting. These expected roles and co-use patterns were congruent among all 3 stakeholders; the co-use of CHT was desired to be minimally invasive for parents and health care providers and controlled by the adolescents. Conclusions: Our study integrates and extends the perspectives of 2 seminal models to explore design features and social influence roles for the successful user-centered design of CHT for weight self-management in adolescents. Although the co-users (ie, adolescents, parents, health care providers) suggested differing features consistent with their roles, role definitions were congruent. All users recognized the adolescent as the primary user with differential, supportive use from parents and health care providers. This multistakeholder approach can guide successful CHT design that reinforces the collective perspective of self-management.

  • JMIR Mhealth Uhealth 2020;8(6):e18391

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  mHealth in a Clinical Setting

  Jun 26, 2020

  Assessing the Impact of Patient-Facing Mobile Health Technology on Patient Outcomes: Retrospective Observational Cohort Study

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  Authors List:

  • Courtenay R Bruce  
  • Patricia Harrison  
  • Tariq Nisar  
  • Charlie Giammattei  
  • Neema M Tan  
  • Caitlin Bliven  
  • Jamie Shallcross  
  • Aroub Khleif  
  • Nhan Tran  
  • Sayali Kelkar  
  • Noreen Tobias  
  • Ana E Chavez  
  • Dana Rivera  
  • Angela Leong  
  • Angela Romano  
  • S Nicholas Desai  
  • Josh R Sol  
  • Kayla Gutierrez  
  • Christopher Rappel  
  • Eric Haas  
  • Feibi Zheng  
  • Kwan J Park  
  • Stephen Jones  
  • Paul Barach  
  • Roberta Schwartz  

  Abstract:

  Background: Despite the growth of and media hype about mobile health (mHealth), there is a paucity of literature supporting the effectiveness of widespread implementation of mHealth technologies. Objective: This study aimed to assess whether an innovative mHealth technology system with several overlapping purposes can impact (1) clinical outcomes (ie, readmission rates, revisit rates, and length of stay) and (2) patient-centered care outcomes (ie, patient engagement, patient experience, and patient satisfaction). Methods: We compared all patients (2059 patients) of participating orthopedic surgeons using mHealth technology with all patients of nonparticipating orthopedic surgeons (2554 patients). The analyses included Wilcoxon rank-sum tests, Kruskal-Wallis tests for continuous variables, and chi-square tests for categorical variables. Logistic regression models were performed on categorical outcomes and a gamma-distributed model for continuous variables. All models were adjusted for patient demographics and comorbidities. Results: The inpatient readmission rates for the nonparticipating group when compared with the participating group were higher and demonstrated higher odds ratios (ORs) for 30-day inpatient readmissions (nonparticipating group 106/2636, 4.02% and participating group 54/2048, 2.64%; OR 1.48, 95% CI 1.03 to 2.13; P=.04), 60-day inpatient readmissions (nonparticipating group 194/2636, 7.36% and participating group 85/2048, 4.15%; OR 1.79, 95% CI 1.32 to 2.39; P<.001), and 90-day inpatient readmissions (nonparticipating group 261/2636, 9.90% and participating group 115/2048, 5.62%; OR 1.81, 95% CI 1.40 to 2.34; P<.001). The length of stay for the nonparticipating cohort was longer at 1.90 days, whereas the length of stay for the participating cohort was 1.50 days (mean 1.87, SD 2 vs mean 1.50, SD 1.37; P<.001). Patients treated by participating surgeons received and read text messages using mHealth 83% of the time and read emails 84% of the time. Patients responded to 60% of the text messages and 53% of the email surveys. Patients were least responsive to digital monitoring questions when the hospital asked them to do something, and they were most engaged with emails that did not require action, including informational content. A total of 96% (558/580) of patients indicated high satisfaction with using mHealth technology to support their care. Only 0.40% (75/2059) patients opted-out of the mHealth technology program after enrollment. Conclusions: A novel, multicomponent, pathway-driven, patient-facing mHealth technology can positively impact patient outcomes and patient-reported experiences. These technologies can empower patients to play a more active and meaningful role in improving their outcomes. There is a deep need, however, for a better understanding of the interactions between patients, technology, and health care providers. Future research is needed to (1) help identify, address, and improve technology usability and effectiveness; (2) understand patient and provider attributes that support adoption, uptake, and sustainability; and (3) understand the factors that contribute to barriers of technology adoption and how best to overcome them.

  • JMIR Mhealth Uhealth 2020;8(6):e19333

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  Viewpoint

  Jun 26, 2020

  Medical Device Apps: An Introduction to Regulatory Affairs for Developers

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  Authors List:

  • Lina Keutzer  
  • Ulrika SH Simonsson  

  Abstract:

  The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017. After a transition period of 3 years, the regulations must be implemented in all EU and European Economic Area member states. The implementation of this regulation bears many changes for medical device development and marketing, including medical device software and mobile apps. Medical device development and marketing is a complex process by which manufacturers must keep many regulatory requirements and obligations in mind. The objective of this paper is to provide an introduction and overview of regulatory affairs for manufacturers that are new to the field of medical device software and apps with a specific focus on the new MDR, accompanying harmonized standards, and guidance documents from the European Commission. This work provides a concise overview of the qualification and classification of medical device software and apps, conformity assessment routes, technical documentation, clinical evaluation, the involvement of notified bodies, and the unique device identifier. Compared to the previous Medical Device Directive (MDD) 93/42/EEC, the MDR provides greater detail about the requirements for software qualification and classification. In particular, rule 11 sets specific rules for the classification of medical device software and will be described in this paper. In comparison to the previous MDD, the MDR is more stringent, especially regarding the classification of health apps and software. The implementation of the MDR in May 2020 and its interpretation by the authorities will demonstrate how app and software manufacturers as well as patients will be affected by the regulation.

  • JMIR Mhealth Uhealth 2020;8(6):e17567

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  mHealth for Wellness, Behavior Change...

  Jun 26, 2020

  Evaluation of the Tobbstop Mobile App for Smoking Cessation: Cluster Randomized Controlled Clinical Trial

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  Authors List:

  • Meritxell Pallejà-Millán  
  • Cristina Rey-Reñones  
  • Maria Luisa Barrera Uriarte  
  • Esther Granado-Font  
  • Josep Basora  
  • Gemma Flores-Mateo  
  • Jordi Duch  

  Abstract:

  Background: Mobile apps provide an accessible way to test new health-related methodologies. Tobacco is still the primary preventable cause of death in industrialized countries, constituting an important public health issue. New technologies provide novel opportunities that are effective in the cessation of smoking tobacco. Objective: This paper aims to evaluate the efficacy and usage of a mobile app for assisting adult smokers to quit smoking. Methods: We conducted a cluster randomized clinical trial. We included smokers older than 18 years who were motivated to stop smoking and used a mobile phone compatible with our mobile app. We carried out follow-up visits at 15, 30, and 45 days, and at 2, 3, 6, and 12 months. Participants of the intervention group had access to the Tobbstop mobile app designed by the research team. The primary outcomes were continuous smoking abstinence at 3 and 12 months. Results: A total of 773 participants were included in the trial, of which 602 (77.9%) began the study on their D-Day. Of participants in the intervention group, 34.15% (97/284) did not use the app. The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01). Participants in the intervention group who used the app regularly and correctly had a higher probability of not being smokers at 12 months (OR 7.20, 95% CI 2.14-24.20; P=.001) than the participants of the CG. Conclusions: Regular use of an app for smoking cessation is effective in comparison with standard clinical practice. Trial Registration: Clinicaltrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421

  • JMIR Mhealth Uhealth 2020;8(6):e15951

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  Digital Biomarkers and Digital...

  Jun 26, 2020

  Testing Suicide Risk Prediction Algorithms Using Phone Measurements With Patients in Acute Mental Health Settings: Feasibility Study

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  Authors List:

  • Alina Haines-Delmont  
  • Gurdit Chahal  
  • Ashley Jane Bruen  
  • Abbie Wall  
  • Christina Tara Khan  
  • Ramesh Sadashiv  
  • David Fearnley  

  Abstract:

  Background: Digital phenotyping and machine learning are currently being used to augment or even replace traditional analytic procedures in many domains, including health care. Given the heavy reliance on smartphones and mobile devices around the world, this readily available source of data is an important and highly underutilized source that has the potential to improve mental health risk prediction and prevention and advance mental health globally. Objective: This study aimed to apply machine learning in an acute mental health setting for suicide risk prediction. This study uses a nascent approach, adding to existing knowledge by using data collected through a smartphone in place of clinical data, which have typically been collected from health care records. Methods: We created a smartphone app called Strength Within Me, which was linked to Fitbit, Apple Health kit, and Facebook, to collect salient clinical information such as sleep behavior and mood, step frequency and count, and engagement patterns with the phone from a cohort of inpatients with acute mental health (n=66). In addition, clinical research interviews were used to assess mood, sleep, and suicide risk. Multiple machine learning algorithms were tested to determine the best fit. Results: K-nearest neighbors (KNN; k=2) with uniform weighting and the Euclidean distance metric emerged as the most promising algorithm, with 68% mean accuracy (averaged over 10,000 simulations of splitting the training and testing data via 10-fold cross-validation) and an average area under the curve of 0.65. We applied a combined 5×2 F test to test the model performance of KNN against the baseline classifier that guesses training majority, random forest, support vector machine and logistic regression, and achieved F statistics of 10.7 (P=.009) and 17.6 (P=.003) for training majority and random forest, respectively, rejecting the null of performance being the same. Therefore, we have taken the first steps in prototyping a system that could continuously and accurately assess the risk of suicide via mobile devices. Conclusions: Predicting for suicidality is an underaddressed area of research to which this paper makes a useful contribution. This is part of the first generation of studies to suggest that it is feasible to utilize smartphone-generated user input and passive sensor data to generate a risk algorithm among inpatients at suicide risk. The model reveals fair concordance between phone-derived and research-generated clinical data, and with iterative development, it has the potential for accurate discriminant risk prediction. However, although full automation and independence of clinical judgment or input would be a worthy development for those individuals who are less likely to access specialist mental health services, and for providing a timely response in a crisis situation, the ethical and legal implications of such advances in the field of psychiatry need to be acknowledged. Trial Registration:

  • JMIR Mhealth Uhealth 2020;8(6):e15901

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  mHealth for Telemedicine and Homecare

  Jun 25, 2020

  Telemedicine in Chronic Wound Management: Systematic Review And Meta-Analysis

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  Authors List:

  • Lihong Chen  
  • Lihui Cheng  
  • Wei Gao  
  • Dawei Chen  
  • Chun Wang  
  • Xingwu Ran  

  Abstract:

  Background: Chronic wounds have been a great burden to patients and the health care system. The popularity of the internet and smart devices, such as mobile phones and tablets, has made it possible to adopt telemedicine (TM) to improve the management of chronic wounds. However, studies conducted by different researchers have reported contradictory results on the effect of TM on chronic wound management. Objective: The aim of this work was to evaluate the efficacy and safety of TM in chronic wound management. Methods: We systematically searched multiple electronic databases (MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials [CENTRAL]) to identify eligible studies published from inception to June 12, 2019. Inclusion criteria were randomized controlled trials (RCTs) and interventional cohort studies that investigated the use of TM in chronic wound management. RCT and observational data were analyzed separately. A meta-analysis and qualitative analysis were conducted to estimate endpoints. Results: A total of 6 RCTs and 6 cohort studies including 3913 patients were included. Of these, 4 studies used tablets or mobile phones programmed with apps, such as Skype and specialized interactive systems, whereas the remaining 8 studies used email, telephone, and videoconferencing to facilitate the implementation of TM using a specialized system. Efficacy outcomes in RCTs showed no significant differences in wound healing (hazard ratio [HR] 1.16, 95% CI 0.96-1.39; P=.13), and wound healing around 1 year (risk ratio [RR] 1.05, 95% CI 0.89-1.23; P=.15). Noninferiority criteria of TM were met. A decreased risk of amputation in patients receiving TM was revealed (RR 0.45, 95% CI 0.29-0.71; P=.001). The result of cohort studies showed that TM was more effective than standard care (HR 1.74, 95% CI 1.43-2.12; P<.001), whereas the outcome efficacy RR of wound healing around 1 year (RR 1.21, 95% CI 0.96-1.53; P=.56) and 3 months (RR 1.24, 95% CI 0.47-3.3; P=.67) was not significantly different between TM and standard care. Noninferiority criteria of TM were met for wound healing around 1 year in cohort studies. Conclusions: Currently available evidence suggests that TM seems to have similar efficacy and safety, and met noninferiority criteria with conventional standard care of chronic wounds. Large-scale, well-designed RCTs are warranted.

  • JMIR Mhealth Uhealth 2020;8(6):e15574

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