scholarly journals CE accreditation and barriers to CE marking of paediatric drug calculators for mobile devices: a scoping review and qualitative analysis (Preprint)

Author(s):  
Charlotte Koldeweij ◽  
Jonathan Clarke ◽  
Joppe Nijman ◽  
Calandra Feather ◽  
Saskia de Wildt ◽  
...  
Healthcare ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. 96 ◽  
Author(s):  
Hannah Ramsden Marston ◽  
Robin Hadley ◽  
Duncan Banks ◽  
María Del Carmen Miranda Duro

The use and deployment of mobile devices across society is phenomenal with an increasing number of individuals using mobile devices to track their everyday health. However, there is a paucity of academic material examining this recent trend. Specifically, little is known about the use and deployment of mobile heart monitoring devices for measuring palpitations and arrhythmia. In this scoping literature review, we identify the contemporary evidence that reports the use of mobile heart monitoring to assess palpitations and arrhythmia across populations. The review was conducted between February and March 2018. Five electronic databases were searched: Association for Computing Machinery (ACM), CINHAL, Google Scholar, PubMed, and Scopus. A total of 981 records were identified and, following the inclusion and exclusion criteria, nine papers formed the final stage of the review. The results identified a total of six primary themes: purpose, environment, population, wearable devices, assessment, and study design. A further 24 secondary themes were identified across the primary themes. These included detection, cost effectiveness, recruitment, type of setting, type of assessment, and commercial or purpose-built mobile device. This scoping review highlights that further work is required to understand the impact of mobile heart monitoring devices on how arrhythmias and palpitations are assessed and measured across all populations and ages of society. A positive trend revealed by this review demonstrates how mobile heart monitoring devices can support primary care providers to deliver high levels of care at a low cost to the service provider. This has several benefits: alleviation of patient anxiety, lowering the risk of morbidity and mortality, while progressively influencing national and international care pathway guidelines. Limitations of this work include the paucity of knowledge and insight from primary care providers and lack of qualitative material. We argue that future studies consider qualitative and mixed methods approaches to complement quantitative methodologies and to ensure all actors’ experiences are recorded.


Sports ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. 66 ◽  
Author(s):  
Benjamin Raysmith ◽  
Jenny Jacobsson ◽  
Michael Drew ◽  
Toomas Timpka

Purpose: This review set out to summarise, define, and provide future direction towards the use of performance outcome measures as endpoints in research performed at international benchmark events in athletics. Methods: Scoping review methodology was applied through a search of the PubMed and Sports Discus databases and a systematic article selection procedure. Articles that met the inclusion criteria underwent triage for further quantitative and qualitative analysis. A concept chart was generated to describe the methods by which performance had been measured and introduce descriptive labels for theoretical and practical application. Results: None of 2972 articles primarily identified from the database search met the triage standards for quantitative data extraction. Eleven articles were included in a qualitative analysis. The analysis identified the common methods by which performance has been measured, reported and analysed. The resulting concept chart collates labels from the qualitative analysis (categories, themes, and constructs) with sports practice labels (performance metrics, framework, and analysis). Conclusions: The state of knowledge concerning methods to employ performance metrics as endpoints in studies performed at major competitions in athletics has been summarised. Constructing a methodology that combines the performance metric variables (continuous and ordinal) that are currently utilised as endpoints remains a challenge.


2014 ◽  
Vol 21 (4) ◽  
pp. 306-315 ◽  
Author(s):  
Judith W Dexheimer ◽  
Elizabeth M Borycki

2021 ◽  
Vol 11 (12) ◽  
pp. 5707
Author(s):  
Patricia Acosta-Vargas ◽  
Belén Salvador-Acosta ◽  
Luis Salvador-Ullauri ◽  
William Villegas-Ch. ◽  
Mario Gonzalez

The objective of this scoping review is to characterize the current scenario of mobile applications considering accessibility issues for people with cognitive, motor, and sensory disabilities. Nowadays, mobile devices have grown exponentially, giving way to new ways of relating, managing, and working. In this context, mobile devices seek to democratize access to knowledge on different topics; however, the application of accessibility guidelines is neglected. The reviewers extracted the most relevant articles published between 2000 and 2020 from the ACM Digital Library, IEEE Xplore, ScienceDirect, Scopus, and Web of Science databases. In this scoping review, the PRISMA-ScR checklist was used to extract scientific articles; Cohen’s kappa coefficient = 0.4117 was applied, which implies moderate concordance of reviewers; 22 primary studies were extracted from a total of 211. The results obtained in this research suggest applying WCAG 2.1 in mobile applications to achieve an adequate level of accessibility. Future work suggests designing review tools that include machine learning based on artificial intelligence algorithms.


Author(s):  
Sachin K. Garg ◽  
Courtney R. Lyles ◽  
Sara Ackerman ◽  
Margaret A. Handley ◽  
Dean Schillinger ◽  
...  

2021 ◽  
Author(s):  
Charlotte Koldeweij ◽  
Jonathan Clarke ◽  
Joppe Nijman ◽  
Calandra Feather ◽  
Saskia de Wildt ◽  
...  

BACKGROUND Paediatric drug calculators (PDCs) intended for clinical use qualify as medical devices under the Medical Device Directive and the Medical Device Regulation. The extent to which they comply with European standards on quality and safety is unknown. OBJECTIVE Determine the number of PDCs available as mobile applications for use in the Netherlands that bear a CE mark and explore the factors influencing the CE marking of such devices among application developers. METHODS A scoping review of the Google Play and App stores was conducted to identify PDCs available for download in the Netherlands. CE accreditation of the sampled applications was determined by consulting the application landing pages on application stores, by screening the United Kingdom Medicines and Healthcare products Regulatory Agency online registry of medical devices and by surveying application developers. The barriers to CE accreditation were also explored through a survey of application developers. RESULTS Out of 632 screened applications, 74 were eligible, including 60 paediatric drug dosage calculators and 14 infusion rate calculators. One application was CE marked. Of the twenty (34%) respondents to the survey, eight considered their application not to be a medical device based on its intent of use or functionality. Three developers had not aimed to make their application available for use in Europe. Other barriers that may explain the limited CE accreditation of sampled PDC applications included poor awareness of European regulations among developers and a lack of restrictions when placing PDCs in application stores. CONCLUSIONS The compliance of paediatric drug calculators with European standards on medical devices is poor. This puts clinicians and their patients at risk of medical errors resulting from the largely unrestricted use of these applications.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 865-865
Author(s):  
Priyanka Mehta ◽  
Chalise Carlson ◽  
Jason Anderson ◽  
Ana Alfaro ◽  
Erin Sakai ◽  
...  

Abstract Many older veterans have access to mobile devices and are interested in using apps for mental health self-management, but few have ever downloaded health apps. To address the need for awareness of and access to VA mental health apps, we developed patient educational materials aimed towards older (or novice) users of mobile devices. The present study explored health care providers’ and staff’s perceptions about use of mental health mobile applications (apps) with older veterans and examined potential utility of these patient educational materials. Requestors of mobile device education materials (N = 90) were surveyed when ordering materials and again 4 months later. Baseline and follow-up surveys assessed frequency of app recommendation, and comfort recommending apps. Baseline surveys examined perceived advantages of apps; follow-up surveys examined perceived utility of the educational materials. Descriptive statistics and qualitative analysis were conducted. Most requesters (68.5%) initially were not comfortable using apps, yet perceived many advantages to using apps and hoped materials could facilitate app use. At follow-up, requestors felt more comfortable recommending apps alongside our materials. Qualitative analysis revealed perceived advantages to using the education materials. The benefits of developing and disseminating educational materials for providers to share with older veterans helped support older veterans’ app use, and potentially increased providers’ comfort with and frequency of recommending apps to their older patients. Access to educational materials can mitigate discomfort among providers in recommending apps to older users and may bring about valuable discussions about apps which support mental health.


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