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).

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.