Barriers to and facilitators of paediatric medical device innovation: a scoping review protocol.

INTRODUCTION: The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials have been identified as a pain point, but components of effective clinical research infrastructure are poorly understood. As part of a multimodal research strategy, the Pediatric Device Consortia (PDC) will conduct a scoping review to better understand infrastructural barriers to and facilitators of paediatric medical device clinical research identified in the health sciences literature. METHODS AND ANALYSIS: The following databases will be included for this review: Medline, Embase, Cochrane CENTRAL, Web of Science and IEEE Xplore. Additional grey literature will be sought out through Google Scholar and reviewing the citations of included studies. Included studies will discuss medical devices according to the U.S. Food and Drug Administration classification, focus on the paediatric population (ages 0-21 years) and involve human premarket or postmarket research. All study types that were published in 2007-present in English, Spanish, French or Italian will be included. Using Covidence web-based software, two independent reviewers will screen the resulting titles, abstracts and the full text of potential studies. Conflicts will be resolved by the primary investigator during both phases. REDCap will be used for quantitative and qualitative data charting, generating data tables and narrative synthesis. ETHICS AND DISSEMINATION: This research did not require research ethics board consideration as it does not involve human participants and all data will be collected from published literature. We will share our findings through peer-reviewed manuscripts, clinical and research conference presentations and professional networks available to the PDC. STUDY REGISTRATION: Open Science Framework (https://osf.io/k72bn).

International Collaboration to Develop a Remote Monitoring Web App for COVID-19 Patients in Armenia: Design and Development With Agile Methodology.

BACKGROUND: COVID-19 has led to over 500 million cases and 6.2 million deaths around the world. Low- and middle-income countries (LMICs) like Armenia face unique infrastructure, financial, and capacity challenges that in many cases result in worse outcomes. Health care facilities across Armenia experienced a shortage of resources, including hospital beds and oxygen, which was further exacerbated by the war with neighboring Azerbaijan. Without a framework for home-based care, health care facilities were severely strained by COVID-19 patients who had prolonged oxygen requirements but were otherwise clinically stable. OBJECTIVE: This paper describes our approach to establishing an international collaboration to develop a web app to support home monitoring of patients with COVID-19 with persistent oxygen requirements. METHODS: The app was developed using a rapid, coordinated, and collaborative approach involving an international group of clinicians, developers, and collaborators. Health screening, monitoring, and discharge forms were developed into a lightweight OpenMRS web app and customized for the local Armenian context. RESULTS: The software was designed and developed over 2 months using human-centered design and agile sprints. Once live, 5087 patient records were created for 439 unique patients. CONCLUSIONS: This project suggests a promising framework for designing and implementing remote monitoring programs in LMICs, despite pandemic and geopolitical challenges.

Using a Facebook Virtual Examination Room to Enhance ROP Training in Armenia.

Purpose: Retinopathy of prematurity (ROP) is a leading cause of worldwide childhood blindness with increasing incidence in low and middle income countries (LMICs) due to advances in neonatal care. There are insufficient numbers of healthcare professionals specialized in ROP management and few local training opportunities in LMICs. Social media platforms provide a promising solution to enable interactive medical education across geographic and logistic barriers. As an adjunct to an ROP training program for ophthalmologists in Armenia, we implemented a Facebook Virtual Examination Room (VER) for case discussion with a global community of collaborators and preceptors. To evaluate training through VER, we operationalized engagement as a multilayer meta-construct that includes cognitive, behavioral, and social-emotional domains. Methods: A concurrent mixed methods approach was taken to collect and analyze data from comments and activities within VER. Quantitative data was analyzed for descriptive statistics on group utilization, participant activity, and clinical metrics. Qualitative data was analyzed by conducting thematic analysis involving initial and pattern coding. Results: Ten participants (7 trainees and 3 preceptors) interacted in the Facebook group across 153 unique cases, with 218 threads, 414 comments, and 216 likes. Of the 120 unique cases eligible for consensus evaluation, treatment was mentioned most frequently (87), followed by location (68), staging (65), and plus disease (31), with agreement ranging from 67% to 97%. Based on the qualitative analysis, the most common themes of discussion were clinical management, dilemma resolution, knowledge growth, and gratitude. Conclusion: A closed Facebook group for case-based discussions can be a useful adjunct to an existing ROP training program by engaging learners across social-emotional, behavioral, and cognitive domains. For international training partnerships, the financial and logistical advantages can be significant, though focus should remain on the primary curriculum and training modality.

Mentalizing imagery therapy to augment skills training for dementia caregivers: Protocol for a randomized, controlled trial of a mobile application and digital phenotyping.

More than 50 million people worldwide live with a dementia, and most are cared for by family members. Family caregivers often experience chronic stress and insomnia, resulting in decreased mental and physical health. Accessibility of in-person stress reduction therapy is limited due to caregiver time constraints and distance from therapy sites. Mentalizing imagery therapy (MIT) provides mindfulness and guided imagery tools to reduce stress, promote self and other understanding, and increase feelings of interconnectedness. Combining MIT with caregiver skills training might enable caregivers to both reduce stress and better utilize newly learned caregiving skills, but this has never been studied. Delivering MIT through a smartphone application (App) has the potential to overcome difficulties with scalability and dissemination and offers caregivers an easy-to-use format. Harnessing passive smartphone data provides an important opportunity to study behavioral changes continuously and with higher granularity than routine clinical assessments. This protocol describes a randomized, controlled, superiority trial in which 120 family dementia caregivers, aged 60 years or older, will be assigned to smartphone App delivery of caregiver skills with MIT (experimental condition) or without MIT (control condition). The primary objectives of the trial are to assess whether the experimental condition is superior to control on reducing family caregiver stress, insomnia and related outcomes and to demonstrate the feasibility of developing behavioral markers from passive smartphone data that predict health outcomes in older adults. Trial outcomes may inform the suitability of our intervention for caregivers and provide new methods for assessment of older adults.

Pattern and prevalence of eye disorders and diseases in school-aged children: findings from the Nationwide School Sight Sampling Survey in Armenia.

Objective: This study aims to identify the prevalence of eye disorders and their causes among secondary schoolchildren aged 6-15 years old in Armenia, based on analysis of the Nationwide School Sight Sampling Survey. Methods and Analysis: A two-stage proportionate stratified cluster sample was designed for the survey. 22 600 students were screened for visual acuity in schools; 5944 of them were selected for analysis as a nationally representative sample. Those with 20/40 or worse vision were referred to photoscreening and rapid ophthalmic assessment in schools and then were provided with vouchers for free comprehensive eye examination in eye clinics. Data were collected through data collection forms and analysed using SPSS V.23. Results: While majority of the children (85%) had normal vision, 15% had a visual acuity ≤20/40. The prevalence of vision impairment (VI) in at least one eye was 9.7% and blindness in at least one eye was 0.05%. The prevalence of abnormal vision and VI was higher among girls and older children. VI was more prevalent in urban areas. The most common diagnoses were myopia (60%), astigmatism (33.7%), hyperopia (29.5%) and strabismus (3.8%). Conclusion: Majority of the vision abnormalities and VI among schoolchildren are a result of refractive error and are treatable. Our results highlight the importance of regular eye examinations for schoolchildren to detect and prevent VI. Raising awareness among parents, school staff and children about eye health is vital.

Assessing Health Data Security Risks in Global Health Partnerships: Development of a Conceptual Framework.

BACKGROUND: Health care databases contain a wealth of information that can be used to develop programs and mature health care systems. There is concern that the sensitive nature of health data (eg, ethnicity, reproductive health, sexually transmitted infections, and lifestyle information) can have significant impact on individuals if misused, particularly among vulnerable and marginalized populations. As academic institutions, nongovernmental organizations, and international agencies begin to collaborate with low- and middle-income countries to develop and deploy health information technology (HIT), it is important to understand the technical and practical security implications of these initiatives. OBJECTIVE: Our aim is to develop a conceptual framework for risk stratification of global health data partnerships and HIT projects. In addition to identifying key conceptual domains, we map each domain to a variety of publicly available indices that could be used to inform a quantitative model. METHODS: We conducted an overview of the literature to identify relevant publications, position statements, white papers, and reports. The research team reviewed all sources and used the framework method and conceptual framework analysis to name and categorize key concepts, integrate them into domains, and synthesize them into an overarching conceptual framework. Once key domains were identified, public international data sources were searched for relevant structured indices to generate quantitative counterparts. RESULTS: We identified 5 key domains to inform our conceptual framework: State of HIT, Economics of Health Care, Demographics and Equity, Societal Freedom and Safety, and Partnership and Trust. Each of these domains was mapped to a number of structured indices. CONCLUSIONS: There is a complex relationship among the legal, economic, and social domains of health care, which affects the state of HIT in low- and middle-income countries and associated data security risks. The strength of partnership and trust among collaborating organizations is an important moderating factor. Additional work is needed to formalize the assessment of partnership and trust and to develop a quantitative model of the conceptual framework that can help support organizational decision-making.

Mentalizing Imagery Therapy Mobile App to Enhance the Mood of Family Dementia Caregivers: Feasibility and Limited Efficacy Testing.

BACKGROUND: Family caregivers of patients with Alzheimer disease and related dementias (AD and ADRD) often experience high stress and are at high risk for depression. Technologically delivered therapy is attractive for AD and ADRD caregivers because of the time demands associated with in-person participation. OBJECTIVE: We aimed to study the feasibility and conduct limited efficacy testing of a mobile app intervention delivering mentalizing imagery therapy (MIT) for family caregivers. METHODS: A 4-week trial of the MIT app for family AD and ADRD caregivers was conducted to assess the feasibility of use and investigate changes in depression symptoms, mood, and caregiving experience. Semistructured interviews were conducted to characterize participants' perceived feasibility and benefits. RESULTS: A total of 17 of the 21 (80%) consented participants (mean age 67 years, range 54-79) utilized the app at least once and were further analyzed. Average usage of audio recordings was on 14 (SD 10) days out of 28 possible and comprised 29 (SD 28) individual sessions. There were improvements in depression with a large effect size for those who used the app at least moderately (P=.008), increases in positive mood postintervention (P<.05), and acute increases in mood following daily guided imagery practice (Stretching and Breathing, P<.001; Eye in the Center, P<.001; Nesting Doll, P=.002; Situation Solver, P=.003; and Life Globe, P=.006). Semistructured interviews revealed perceived benefits such as greater ability to remain "centered" despite caregiving challenges and positive reframing of the caregiver experience. CONCLUSIONS: App delivery of MIT is feasible for family AD and ADRD caregivers, including aging seniors. Results showed moderate to high usage of the app for a majority of users. Limited efficacy testing provides justification for studying the MIT app for AD and ADRD caregivers to improve mood and reduce depression in larger, controlled trials.