Filling the gaps in the evaluation and selection of mobile health technologies in respiratory medicine.

INTRODUCTION: Mobile health (mHealth) technology in respiratory medicine is a fast-growing and promising digital technology that is popular among patients and healthcare providers (HCPs). They provide reminders and step-by-step instructions for the correct inhalation technique, monitor patients' adherence to treatment, and facilitate communication between patients and HCPs. AREAS COVERED: While numerous mHealth apps have been developed over the years, most applications do not have supporting evidence. Selecting the best mHealth app in respiratory medicine is challenging due to limited studies carrying out mHealth app selection. Although mHealth technologies play an important part in the future of respiratory medicine, there is no single guide on the evaluation and selection of mHealth technologies for patients with pulmonary diseases. This paper aims to provide an overview of mHealth technologies, particularly emphasizing digital inhalers and standalone applications used in asthma. Additionally, it offers insights into the evaluation, selection, and pertinent considerations surrounding mHealth applications in respiratory medicine. EXPERT OPINION: Evaluating mHealth apps will take time, resources, and collaboration between stakeholders such as governmental regulatory bodies, subject-matter experts, and industry representatives. Filling the gaps in the evaluation and selection of the mHealth app will improve clinical decision-making, personalized treatments, self-management and disease monitoring in respiratory medicine.

Methods for the Clinical Validation of Digital Endpoints: Protocol for a Scoping Review Abstract.

BACKGROUND: Clinical trials often use digital technologies to collect data continuously outside the clinic and use the derived digital endpoints as trial endpoints. Digital endpoints are also being developed to support diagnosis, monitoring, or therapeutic interventions in clinical care. However, clinical validation stands as a significant challenge, as there are no specific guidelines orienting the validation of digital endpoints. OBJECTIVE: This paper presents the protocol for a scoping review that aims to map the existing methods for the clinical validation of digital endpoints. METHODS: The scoping review will comprise searches from the electronic literature databases MEDLINE (PubMed), Scopus (including conference proceedings), Embase, IEEE (Institute of Electrical and Electronics Engineers) Xplore, ACM (Association for Computing Machinery) Digital Library, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science Core Collection (including conference proceedings), and Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports. We will also include various sources of gray literature with search terms related to digital endpoints. The methodology will adhere to the Joanna Briggs Institute Scoping Review and the Guidance for Conducting Systematic Scoping Reviews. RESULTS: A search for reviews on the existing evidence related to this topic was conducted and has shown that no such review was previously undertaken. This review will provide a systematic assessment of the literature on methods for the clinical validation of digital endpoints and highlight any potential need for harmonization or reporting of methods. The results will include the methods for the clinical validation of digital endpoints according to device, digital endpoint, and clinical application goal of digital endpoints. The study started in January 2023 and is expected to end by December 2023, with results to be published in a peer-reviewed journal. CONCLUSIONS: A scoping review of methodologies that validate digital endpoints is necessary. This review will be unique in its breadth since it will comprise digital endpoints collected from several devices and not focus on a specific disease area. The results of our work should help guide researchers in choosing validation methods, identify potential gaps in the literature, or inform the development of novel methods to optimize the clinical validation of digital endpoints. Resolving these gaps is the key to presenting evidence in a consistent way to regulators and other parties and obtaining regulatory acceptance of digital endpoints for patient benefit. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47119.

The results of following type 2 diabetes patients with mobile health services during the COVID-19 pandemic.

OBJECTIVE: The aim of this study is to determine the level of compliance with treatment and achieving metabolic goals in type 2 diabetes mellitus (T2DM) patients who are remotely monitored with mobile health (mHealth) technologies during the pandemic. METHODS: A total number of 86 patients were included in the study. Data from two periods were used: from 1 month before the date when the first COVID-19 case in Turkiye was reported on March 11, 2020 (Febraury 10, 2020-March 31, 2020) and from the pandemic was severe between April 01, 2020 and May 31, 2020. Participants' mean blood glucose, step count, blood pressure, body weight, and diet compliance levels were evaluated. RESULTS: When the blood sugar, blood pressure, and weight averages of the patients were compared between the pre-pandemic period and the pandemic months separately, no significant difference was observed. However, it was observed that the number of steps decreased significantly compared to the period before the pandemic (p<0.05). It was determined that 88% of the participants were able to access health services without applying to the hospital. CONCLUSION: In this study, we showed that patients with T2DM who were followed up with mHealth technologies provided the necessary metabolic control and compliance with the treatment during the pandemic.

Quality of Mobile Apps for Child Development Support: Search in App Stores and Content Analysis.

BACKGROUND: Following increases in smartphone access, more parents seek parenting advice through internet sources, including blogs, web-based forums, or mobile apps. However, identifying quality apps (ones that respond to the diverse experiences of families) for guidance on child development can be challenging. OBJECTIVE: This review of mobile health apps aimed to document the landscape, design, and content of apps in the United States available to parents as they promote their child's developmental health. METHODS: To understand the availability and quality of apps for early childhood health promotion, we completed a content analysis of apps in 2 major app stores (Google Play and Apple App stores). RESULTS: We found that most apps do not provide tailored experiences to parents, including cultural considerations, and instead promote generic guidance that may be useful to parents in some contexts. We discuss the need for an evaluative framework to assess apps aimed to support parents on child development topics. CONCLUSIONS: Future work is needed on how to support designers in this area, specifically related to avoiding potential burdens on users and providing culturally informed and equity-driven experiences.

mHealth Technology Design and Evaluation for Early Childhood Health Promotion: Systematic Literature Review.

BACKGROUND: Recent increases in smartphone ownership among underserved populations have inspired researchers in medicine, computing, and health informatics to design and evaluate mobile health (mHealth) interventions, specifically for those supporting child development and growth. Although these interventions demonstrate possible effectiveness at larger scales, few of these interventions are evaluated to address racial disparities and health equity, which are known factors that affect relevance, uptake, and adherence in target populations. OBJECTIVE: In this study, we aimed to identify and document the current design and evaluation practices of mHealth technologies that promote early childhood health, with a specific focus on opportunities for those processes to address health disparities and health equity. METHODS: We completed a systematic literature review of studies that design and evaluate mHealth interventions for early childhood health promotion. We then analyzed these studies to identify opportunities to address racial disparities in early- and late-stage processes and to understand the potential efficacy of these interventions. RESULTS: Across the literature from medical, computing, and health informatics fields, we identified 15 articles that presented a design or evaluation of a parent-facing health intervention. We found that using mobile-based systems to deliver health interventions was generally well accepted by parents of children aged <5 years. We also found that, when measured, parenting knowledge of early childhood health topics and confidence to engage in health-promoting behaviors improved. Design and evaluation methods held internal consistency within disciplines (eg, experimental study designs were the most prevalent in medical literature, while computing researchers used user-centered design methods in computing fields). However, there is little consistency in design or evaluation methods across fields. CONCLUSIONS: To support more interventions with a comprehensive design and evaluation process, we recommend attention to design at the intervention (eg, reporting content sources) and system level; interdisciplinary collaboration in early childhood health intervention development can lead to large-scale deployment and success among populations. TRIAL REGISTRATION: PROSPERO CRD42022359797; https://tinyurl.com/586nx9a2.

Measuring Mobile Phone Application Usability for Anticoagulation from the Perspective of Patients, Caregivers, and Healthcare Professionals.

Oral anticoagulants (OAC) are recommended for preventing stroke and systemic embolism in atrial fibrillation. Proper use is imperative for maximizing anticoagulation therapy's effectiveness and safety. In preparation for the implementation of a smartphone-based SmartMed app (application) aiming to promote patient self-management, medication adherence, and data collection for patients on anticoagulation therapy, its usability assessment can ensure the value of OAC app development and adoption. We evaluated the SmartMed app's usability using the System Usability Scale (SUS) and the app-specific domain of the Mobile App Rating Scale (MARS) for its perceived impact on taking OAC regularly. We recruited 25 OAC users and their home caregivers and 59 healthcare professionals, including pharmacists, nurses, and cardiac surgeons from one medical center and one regional hospital in Taiwan. All participants (n = 84) thought the SmartMed app was useful, with mean SUS and MARS scores of 81.49 (±14.42) and 4.65 (±0.49), respectively. Usability evaluation revealed that fewer experiences with smartphone apps and different healthcare professionals (pharmacists versus nurses or cardiac surgeons) were associated with lower SUS scores and perceived impact. Throughout the evaluation process, the SmartMed app's design was considered helpful from multiple stakeholders' perspectives. Further ongoing mobile technology supports are necessary to establish the SmartMed app's effectiveness.

Use of Social Media for Implementing Diagnoses, Consultation, Training, and Case Reporting Among Medical Professionals to Improve Patient Care: Case Study of WeChat Groups Across Health Care Settings.

BACKGROUND: Health professionals in low- and middle-resource settings have limited access to up-to-date resources for diagnosing and treating illnesses, training medical staff, reviewing newly disseminated guidelines and publications, and preparing data for international disease reporting. A concomitant difficulty in high-resource settings is the need for continuing education and skills up-training in innovative procedures on unfamiliar social media platforms. These challenges can delay both patient care and epidemiological surveillance efforts. To overcome these challenges, health professionals have adapted WeChat Groups to implement timely, low-cost, and high-quality patient care. OBJECTIVE: The primary study aim was to describe the processes taken by medical professionals across their diverse physical and virtual networks in adapting a bottom-up approach to collectively overcome resource shortages. The secondary study aim was to delineate the pathways, procedures, and resource/information sharing implemented by medical professionals using an international publicly available popular social media app (WeChat) to enhance performance of facility-based procedures and protocols for improved patient care. METHODS: In-depth interviews, observations, and digital ethnography of WeChat Groups communications were collected from medical professionals in interconnected networks of health care facilities. Participants' WeChat Groups usage and observations of their professional functions in interconnected networks were collected from November 2018 to 2019. Qualitative analysis and thematic coding were used to develop constructs and themes in NVivo. Constructs incorporated descriptions for the implementation and uses of WeChat Groups for professional connections, health care procedures, and patient care. Themes supporting the constructs focused on the pathways and venues used by medical professionals to build trust, to establish and solidify online networks, and to identify requests and resource sharing within WeChat Groups. RESULTS: There were 58 participants (males 36 and females 22) distributed across 24 health care settings spanning geographical networks in south China. Analysis yielded 4 constructs and 11 themes delineating the bottom-up usage of WeChat Groups among clinicians, technicians, nurses, pharmacists, and public health administrators. Participants used WeChat Groups for collectively training hospital staff in complex new procedures, processing timely diagnoses of biological specimens, staying abreast of latest trends and clinical procedures and symptoms, and contributing to case reporting for emergent illnesses and international surveillance reporting. An unexpected strength of implementing clinical, training, and research support on a popular app with international coverage is the added ability to overcome administrative and geographic barriers in resource distribution. This advantage increased a network's access to WeChat Groups members both working within China and abroad, greatly expanding the scope of shared resources. CONCLUSIONS: The organic, bottom-up approach of repurposing extant social media apps is low cost and efficient for timely implementation to improve patient care. WeChat's international user base enables medical staff to access widespread professional networks across geographic, administrative, and economic barriers, with potential to reduce health disparities in low-resource settings.

PEGASO e-Diary: User Engagement and Dietary Behavior Change of a Mobile Food Record for Adolescents.

Background: Obesity amongst children and adolescents is becoming a major health problem globally and mobile food records can play a crucial role in promoting healthy dietary habits. Objective: To describe the methodology for the implementation of the e-Diary mobile food record, to assess its capability in promoting healthy eating habits, to evaluate the factors associated with its usage and engagement. Methods: This is a descriptive study that compared the characteristics of participants engaged in the e-Diary, which was part of the PEGASO project in which an app to provide proactive health promotion was given to 365 students at 4 European sites enrolled during October to December 2016: England (UK), Scotland (UK), Lombardy (Italy), and Catalonia (Spain). The e-Diary tracked the users' dietary habits in terms of food groups, dietary indexes, and 6 dietary target behaviors relating to consumption of: fruit; vegetable; breakfast; sugar-sweetened beverages; fast-food; and snacks. The e-Diary provided also personalized suggestions for the next meal and gamification. Results: The e-Diary was used for 6 months by 357 adolescents (53.8% females). The study showed that females used the e-Diary much more than males (aOR 3.8, 95% CI 1.6-8.8). Participants aged 14 years were more engaged in the e-Diary than older age groups (aOR 5.1, 95% CI 1.4-18.8) as were those with a very good/excellent self-perceived health status compared to their peers with fair/poor health perception (aOR 4.2, 95% CI 1.3-13.3). Compared to the intervention sites, those living in Catalonia (aOR 13.2 95% CI 2.5-68.8) were more engaged. In terms of behavior change, a significant positive correlation between fruit (p < 0.0001) and vegetables (p = 0.0087) intake was observed in association with increased engagement in the e-Diary. Similarly, adolescents who used the app for more than 2 weeks had significantly higher odds of not skipping breakfast over the study period (aOR 2.5, 95% CI 1.0-6.3). Conclusions: The users highly engaged with the e-Diary were associated with improved dietary behaviors: increased consumption of fruit and vegetables and reduced skipping of breakfast. Although the overall usage of the e-Diary was high during the first weeks, it declined thereafter. Future applications should foster user engagement, particularly targeting adolescents at high risk. Clinical Trial Registration: https://www.clinicaltrials.gov/, identifier: NCT02930148.

Mobile health assisted self-monitoring is acceptable for supporting weight loss in rural men: a pragmatic randomized controlled feasibility trial.

BACKGROUND: Addressing overweight and obesity among men at-risk for obesity-related diseases and disability in rural communities is a public health issue. Commercial smartphone applications (apps) that promote self-monitoring for weight loss are widely available. Evidence is lacking regarding what support is required to enhance user engagement with and effectiveness of those technologies. Pragmatically comparing these apps effectiveness, including rural men's desired forms of support when using them, can lead to greater weight loss intervention impact and reach. This study assessed the feasibility and acceptability of a mobile technology application applied differently across two groups for weight loss. METHODS: In a two-armed, pragmatic pilot feasibility study, 80 overweight and obese men aged 40-69 were randomized using a 1:1 ratio to either an enhanced Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention. The MT+ group had an enhanced smartphone app for self-monitoring (text messaging, discussion group, Wi-Fi scale) whereas the MT group received a basic app that allowed self-monitoring logging only. Assessments were collected at baseline, 3 and 6 months. App logs were analyzed to track engagement and adherence to self-monitoring. Acceptability was assessed via focus groups. Analysis included descriptive statistics and qualitative content analysis. RESULTS: Of 80 men recruited, forty were allocated to each arm. All were included in the primary analysis. Recruitment ended after 10 months with a 97.5 and 92.5% (3 month, 6 month) retention rate. Over 90% of men reported via survey and focus groups that Lose-It app and smart scale (MT+) was an acceptable way to self-monitor weight, dietary intake and physical activity. Adherence to daily app self-monitoring of at least 800 dietary calories or more (reported respectively as MT+, MT) was positive with 73.4, 51.6% tracking at least 5 days a week. Adherence to tracking activity via recorded steps four or more days weekly was positive, 87.8, 64.6%. Men also adhered to self-weighing at least once weekly, 64, 46.3%. At 6 months, an observed mean weight loss was 7.03 kg (95% CI: 3.67, 10.39) for MT+ group and 4.14 kg (95% CI: 2.22, 6.06) for MT group, with 42.9 and 34.2% meeting ≥5% weight loss, respectively. No adverse events were reported. CONCLUSIONS: This National Institutes of Health-funded pilot study using mobile technologies to support behavior change for weight loss was found to be feasible and acceptable among midlife and older rural men. The interventions demonstrated successful reductions in weight, noting differing adherence to lifestyle behaviors of eating, monitoring and activity between groups, with men in the MT+ having more favorable results. These findings will be used to inform the design of a larger scale, clinical trial. TRIAL REGISTRATION: The trial was prospectively registered with ClinicalTrials NCT03329079 . 11/1/2017.

Current challenges for hypertension management: From better hypertension diagnosis to improved patients' adherence and blood pressure control.

Hypertension control still remains a largely unmet challenge for public health systems. Despite the progress in blood pressure (BP) measurement techniques, and the availability of effective and safe antihypertensive drugs, a large number of hypertensive patients are not properly identified, and a significant proportion of those who receive antihypertensive treatment fail to achieve satisfactory control of their BP levels. It is thus not surprising that hypertension is still a major contributor to disease burden and disability worlwide, even in developed countries. This paper will address current challenges in hypertension management and potential strategies for an improvement in this field. In its first part relevant issues related to hypertension diagnosis will be addressed, in particular how to improve identification of sustained BP elevation and specific BP phenotypes such as white coat and masked hypertension trough the combined use of office and out-of-office BP monitoring techniques. In its second part focus will be on how to improve achievement of hypertension control in treated patients by optimization and simplification of medication regimens, including more efficient selection and titration of antihypertensive drugs and their combinations, aimed at achieving a more consistent 24hBP control; and by favoring a more active patients' and physicians' involvement in hypertension management also through BP telemonitoring and mobile health technologies.

Maternal health-related barriers and the potentials of mobile health technologies: Qualitative findings from a pilot randomized controlled trial in rural Southwestern Uganda.

BACKGROUND: Maternal mortality rate remains unacceptably high in Uganda. In-depth evidence about the barriers to access and utilization of maternal health services specifically among the rural illiterate pregnant women remains lacking. The potentials of mobile health technologies in addressing the maternal health challenges remain unclear. AIM: To explore the maternal health-related barriers among illiterate pregnant women in rural Southwestern Uganda and highlight the potentials of mobile health technologies. MATERIAL AND METHODS: This is a midline qualitative study conducted with the participants of a pilot randomized controlled trial. Between October 2019 and December 2019, we carried out semi-structured interviews with 30 illiterate pregnant mothers. Interviews elicited information on the barriers to access and utilization of maternal health services. An inductive, content analytic approach was used to analyze qualitative data. Quantitative sociodemographic and socioeconomic data were summarized descriptively. RESULTS: Participants reported that lack of money (for transport and medical costs), unfriendly maternal health services, and delays at the maternal health clinic constrain access and utilization of maternal health services. Given their widespread adoption, mobile technologies can potentially address some of these barriers e.g., money for transport or microenterprise start-up can be sent to women through their mobile phones or maternal health-related services (such as health education and consultation) can be provided electronically. CONCLUSION: Future efforts should focus on utilizing mobile health technologies to not only enable women overcome the critical financial challenges but also facilitate remote access and utilization of maternal health services.

Mobile phone-based Multimedia Application Could improve Maternal Health in Rural Southwestern Uganda: Mixed Methods Study.

Background: Reducing maternal and infant mortality rates remains challenging. Illiteracy, lack of reliable information, long distances to health centers continue to limit access to quality maternal healthcare in Uganda. Mobile health technologies could be promising affordable strategies for enhancing access to maternal health services. However, there is lack of studies assessing the experiences of illiterate rural pregnant women regarding these technologies. Objective: To explore how illiterate pregnant women perceive a maternal health mobile application composed of tailored video and audio messages, appointment reminders and calling function. Methods: We purposively sampled illiterate pregnant women initiating antenatal care at Mbarara Regional Referral Hospital. We carried out three focus group discussions with 14 women to elicit information on perceptions of the proposed mobile phone based multimedia application. We used STATA 13 to describe study participants and their preferences. Results: Pregnant women anticipated that intervention would enhance maternal health by reminding them to attend antenatal appointments, enabling transport cost and time saving, providing tailored information that is easy to understand, and recall. However, financial constraints and phone sharing would limit the functionality. Conclusion: Mhealth application may provide acceptable and affordable alternative approaches to providing maternal health services, especially in settings where face-to-face approaches are challenging.

Client preferences and perceptions regarding a written home exercise program or video self-modeling: A cross-sectional study.

STUDY DESIGN: This was a cross-sectional study. INTRODUCTION: Home exercise programs (HEPs) are frequently prescribed to maximize a patient's recovery and ensure maintenance of therapeutic gains produced during supervised treatment. Improved understanding of patient preferences and incorporation of simple mobile health technologies may be beneficial strategies for improving patient HEP adherence. PURPOSE: The purpose of this study was to determine client's preferred mode of home exercise program delivery when offered a choice between a cellular video and paper handout. METHODS: A convenience sample was recruited from clients receiving services at an upper extremity rehabilitation facility. Participants were provided a paper handout with written instructions and an audiovisual recording of themselves performing the exercises. A questionnaire was developed to compare clients' preferences and perceptions. Quantitative data regarding patient preference were gathered and analyzed with descriptive statistics. Collected qualitative data were themed to determine the characteristics of home exercise programs (HEPs) perceived by patients. RESULTS: A total of 30 patients participated in the study. Of the 29 responses regarding patient preference of HEP mode, 20 (69%) patients preferred a video, 4 (14%) patients preferred a paper handout, and 5 (17%) patients preferred both paper and video HEP. Patients with preference to a paper HEP reported the handout was helpful to be accessed in a simple manner and could be displayed as a visual reminder to perform the exercises. Those who preferred the cellular video reported increased understanding and confidence with accurate performance of exercises using audiovisual instructions. DISCUSSION: HEP adherence enhancement techniques include improved understanding of patient preferences in order to facilitate customized client-centered treatment. CONCLUSION: The majority of participants in this study preferred a mobile-based video HEP. Participants perceived the video as visually appealing and a more effective mode of instruction than paper handouts.

Feasibility of Atrial Fibrillation Screening With Mobile Health Technologies at Pharmacies.

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac arrhythmia. Thus, the aim of our study was to evaluate the smartphone-based electrocardiogram (ECG) recordings aimed at AF screening at Polish pharmacies. METHODS: Prospective AF screening among patients aged ≥65 years was conducted at 10 pharmacies using Kardia Mobile with a dedicated application (Kardia app). Prior AF was a study exclusion criterion. CHA2DS2-VASc score (congestive heart failure, hypertension, age, diabetes mellitus, previous stroke/transient ischemic attack, female sex, and vascular disease) has been collected from every patient. A single-lead ECG has been acquired by the placement of fingers from each hand on the pads. Kardia app diagnosis has been evaluated by the cardiologist. RESULTS: A total of 525 ECGs were performed. Kardia app diagnosis was provided in 490 cases. In 437 (89.18%) cases, it was "normal" rhythm, in 17 (3.47%) recordings "possible AF," in 23 (4.69%) ECGs "unreadable," and in 13 (2.65%) "unclassified". After the cardiologist reevaluation, the new AF was identified in 7 (1.33%) patients. Sensitivity and specificity of Kardia app in detecting AF was 100% (95% confidence interval [CI]: 71.5%-100%) and 98.7% (95% CI: 97.3%-99.5%), respectively. The positive predictive value was 64.7% (95% CI: 38.3%-85.7%) and the negative predictive value was 100% (95% CI: 99.2%-100%). CHA2DS2-VASc score was 2.14 ± 0.69 for those with new AF and 3.33 ± 1.26 in the non-AF group. CONCLUSION: Kardia app is capable of fast screening and detecting AF with high sensitivity and specificity. The possible diagnosis of AF deserves additional cardiological evaluation. The results obtained in patients with low CHA2DS2-VASc score and "silent" AF confirm the importance of routine AF screening. Cardiovascular screening with the use of mobile health technology is feasible at pharmacies.

Critical barriers for preeclampsia diagnosis and treatment in low-resource settings: An example from Bolivia.

The goals of the United Nation's Millennium Summit for reducing maternal mortality have proven difficult to achieve. In Bolivia, where maternal mortality is twice the South American average, improving the diagnosis, treatment and ultimately prevention of preeclampsia is key for achieving targeted reductions. We held a workshop in La Paz, Bolivia to review recent revisions in the diagnosis and treatment of preeclampsia, barriers for their implementation, and means for overcoming them. While physicians are generally aware of current recommendations, substantial barriers exist for their implementation due to geographic factors increasing disease prevalence and limiting health-care access, cultural and economic factors affecting the care provided, and infrastructure deficits impeding diagnosis and treatment. Means for overcoming such barriers include changes in the culture of health care, use of standardized diagnostic protocols, the adoption of low-cost technologies for improving the diagnosis and referral of preeclamptic cases to specialized treatment centers, training programs to foster multidisciplinary team approaches, and efforts to enhance local research capacity. While challenging, the synergistic nature of current barriers for preeclampsia diagnosis and treatment also affords opportunities for making far-reaching improvements in maternal, infant and lifelong health.

A roadmap for implementation of patient-centered digital outcome measures in Parkinson's disease obtained using mobile health technologies.

Obtaining reliable longitudinal information about everyday functioning from individuals with Parkinson's disease (PD) in natural environments is critical for clinical care and research. Despite advances in mobile health technologies, the implementation of digital outcome measures is hindered by a lack of consensus on the type and scope of measures, the most appropriate approach for data capture (eg, in clinic or at home), and the extraction of timely information that meets the needs of patients, clinicians, caregivers, and health care regulators. The Movement Disorder Society Task Force on Technology proposes the following objectives to facilitate the adoption of mobile health technologies: (1) identification of patient-centered and clinically relevant digital outcomes; (2) selection criteria for device combinations that offer an acceptable benefit-to-burden ratio to patients and that deliver reliable, clinically relevant insights; (3) development of an accessible, scalable, and secure platform for data integration and data analytics; and (4) agreement on a pathway for approval by regulators, adoption into e-health systems and implementation by health care organizations. We have developed a tentative roadmap that addresses these needs by providing the following deliverables: (1) results and interpretation of an online survey to define patient-relevant endpoints, (2) agreement on the selection criteria for use of device combinations, (3) an example of an open-source platform for integrating mobile health technology output, and (4) recommendations for assessing readiness for deployment of promising devices and algorithms suitable for regulatory approval. This concrete implementation guidance, harmonizing the collaborative endeavor among stakeholders, can improve assessments of individuals with PD, tailor symptomatic therapy, and enhance health care outcomes. © 2019 International Parkinson and Movement Disorder Society.

Heart Rate Variability: An Old Metric with New Meaning in the Era of Using mHealth technologies for Health and Exercise Training Guidance. Part Two: Prognosis and Training.

It has been demonstrated that heart rate variability (HRV) is predictive of all-cause and cardiovascular mortality using clinical ECG recordings. This is true for rest, exercise and ambulatory HRV clinical ECG device recordings in prospective cohorts. Recently, there has been a rapid increase in the use of mobile health technologies (mHealth) and commercial wearable fitness devices. Most of these devices use ECG or photo-based plethysmography and both are validated for providing accurate heart rate measurements. This offers the opportunity to make risk information from HRV more widely available. The physiology of HRV and the available technology by which it can be assessed has been summarised in Part 1 of this review. In Part 2 the association between HRV and risk stratification is addressed by reviewing the current evidence from data acquired by resting ECG, exercise ECG and medical ambulatory devices. This is followed by a discussion of the use of HRV to guide the training of athletes and as a part of fitness programmes.

Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial.

BACKGROUND: Wireless electronic adherence monitors can detect antiretroviral therapy (ART) adherence lapses and trigger interventions in real time, thus potentially avoiding unnecessary HIV viremia. Evidence about the acceptability and feasibility of these monitors and associated interventions, however, is limited. OBJECTIVE: The aim of this study was to assess the acceptability and feasibility of real-time adherence monitoring linked to text messaging (short message service, SMS) reminders and notifications to support adherence among individuals living with HIV who are taking ART in rural southwestern Uganda. METHODS: Individuals living with HIV who were initiating ART were enrolled in a pilot randomized controlled trial and followed up for 9 months. Participants received a real-time adherence monitor and were randomized to one of the following study arms: (1) scheduled SMS, (2) SMS triggered by missed or delayed doses, or (3) no SMS. SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses in the scheduled SMS and triggered SMS arms. Study participants and social supporters participated in qualitative semistructured in-depth interviews on acceptability and feasibility of this technology. An inductive, content analytic approach, framed by the unified theory of acceptance and use of technology model, was used to analyze qualitative data. Quantitative feasibility data, including device functionality and SMS tracking data, were recorded based upon device metrics collected electronically and summarized descriptively. RESULTS: A total of 63 participants participated in the study. Participants reported that real-time monitoring intervention linked to SMS reminders and notifications are generally acceptable; the predominant feedback was perceived utility-the intervention was beneficial in motivating and reminding patients to take medication, as well as enabling provision of social support. The intervention was found to be technically feasible, as data were obtained from most participants as expected most of the time. Potential challenges included the impact of the technology on confidentiality, shared phone ownership, usability skills, and availability of electricity. CONCLUSIONS: Real-time adherence monitoring integrated with SMS reminders and social support notifications is a generally acceptable (based primarily on perceived utility) and feasible intervention in a resource-limited country. Future efforts should focus on optimized device design, user training to overcome the challenges we encountered, cost effectiveness studies, as well as studying the monitoring aspect of the device without accompanying interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT01957865; https://clinicaltrials.gov/ct2/show/NCT01957865 (Archived by WebCite at http://www.webcitation.org/6zFiDlXDa).

A pilot study of a smartphone application supporting recovery from drug addiction.

BACKGROUND: Mobile health (mHealth) technologies have the potential to facilitate self-monitoring and self-management for individuals with substance use disorders (SUD). S-Health is a bilingual smartphone application based on cognitive behavioral principles and is designed to support recovery from drug addiction by trigger recognition so as to allow practice in-the-moment coping to prevent relapse. METHOD: For this pilot randomized controlled study, 75 participants were recruited from methadone maintenance treatment clinics and the social worker consortium in Shanghai, China. Participants in the control group (N=25) received text messages from S-Health (e.g., HIV prevention and other educational materials). Participants in the intervention group (N=50) received both text messages and daily surveys on cravings, affects, triggers, responses to triggers, and social contexts. RESULTS: At the end of the 1-month study trial, 26.2% of the intervention group and 50% of the control group had positive urine test results (p=0.06). Also, the number of days using drug in the past week was significantly lower among participants in the intervention group (Mean=0.71, SD=1.87) relative to the control group (Mean=2.20, SD=3.06) (p<0.05). The two groups did not differ in slopes (i.e., rates of change in outcomes measured weekly) based on the mixed effects model. Participants in the intervention group also preferred answering questions on the cellphone (46.8%) relative to in-person interviews (36.2%). CONCLUSIONS: This pilot demonstrated the feasibility and potential benefits to deliver mobile health intervention among participants with SUD. Further research with larger samples over a longer period of time is needed to test the effectiveness of S-Health as a self-monitoring tool supporting recovery from addiction.

Preparing for the Future of Rare Diseases.

Members of the rare disease community have devoted significant financial and personnel resources to address the numerous issues surrounding rare diseases. The past has been devoted to developing an emphasis on rare diseases including an emphasis on research studies or locating information on rare diseases and the requirements and limitations of conducting clinical trials with small patient populations. The expanded role of patient advocacy organizations and patient engagement in all aspects of clinical research continues to gain acceptance within the research community. The future will require a greater understanding and interpretation of available information from multiple sources including electronic health records and big data sources. The pipeline of potential orphan products continues to grow significantly and holds great promise for novel interventions due to advances in clinical trial design and data analyses. Expanding diagnostic procedures with improved sequencing methods will speed up the diagnosis or rare diseases. Accepting agreed upon nomenclature and codification of rare diseases will assist in differentiating diseases and identifying selected sub-populations of rare diseases. Improvements in patient recruitment and increased flexibility in the product review and approval procedures by regulatory agencies will facilitate product approvals. Children particularly will need help and assistance dealing with feelings of isolation from their peers due to their rare disease. During the transition from childhood to adolescence to adult, difficulties of fitting in with peers and not wanting to be different are a major concern. In response to increasing costs of treatments, Value-Based Care is gaining greater acceptance by the reimbursement and the payer community as a basis for payment for interventions. Mobile Health (M-health) Technologies have the potential to revolutionize how clinical research is conducted in the future. Wearable devices, remote sensors, and the development of mobile device applications (apps) will all assist in constant monitoring of patients for safety and efficacy of approved and investigational compounds. Tele Health and Tele Medicine may provide the necessary access to expert clinicians with a better understanding of individual rare diseases. The future promises great advances and even greater personalized treatments with the introduction of novel treatments and approaches to care.