Diabetic Retinopathy is a complication of diabetes that can cause severe vision impairment or even blindness. The condition is treatable in early stages, but it often progresses asymptomatic and undetected. Once the symptoms become noticeable, damage in the retina might already be permanent, thus many countries have implemented retinal imaging screening programmes for their diabetic population. However, existing screening programmes are not reaching all patients, and Diabetic Retinopathy stands as a leading cause of preventable blindness in the active population. We contend that the existing technological infrastructures and clinical processes may be hindering the coverage of Diabetic Retinopathy screening programmes. This paper presents EyeFundusScopeNEO, a Tele-Ophthalmology system based on a screening information system and a mobile fundus camera, which shall support opportunistic and planned screening in primary care, using cameras that are handheld, non-invasive, avoid drug-induced pupil dilation, are usable by clinicians who are not specialised in Ophthalmology, and that cost a fraction of existing table-top fundus cameras. Preliminary studies indicate the potential of the system to increase the reach of screening programmes and clinical research field trials are under preparation.

Common characteristics of older adults have led to the rise of recommendations to conduct user research and testing with this particular age group. Even though guidelines exist regarding human-centred design with older adults, there are not many reports on experiences with creating and maintaining elderly user groups for design and research purposes. This paper reviews previous reports in the literature about user groups and adds i) results of qualitative research about the experience of researchers who built their entire professional experience with user groups of older adults, along with ii) the authors’ own account of building and maintaining an elderly user group for years. The paper provides recommendations for recruiting, maintaining and motivating elderly user groups towards participation in HCI design and research activities, along with suggestions of strategies to use during field work.

Background: According to the United Nations, it is estimated that by 2050, the number of people aged 80 years and older will have increased by 3 times. Increased longevity is often accompanied by structural and functional changes that occur throughout an individual’s lifespan. These changes are often aggravated by chronic comorbidities, adopted behaviors or lifestyles, and environmental exposure, among other factors. Some of the related outcomes are loss of muscle strength, decreased balance control, and mobility impairments, which are strongly associated with the occurrence of falls in the elderly. Despite the continued undervaluation of the importance of knowledge on fall prevention among the elderly population by primary care health professionals, several evidence-based (single or multifaceted) fall prevention programs such as the Otago Exercise Program (OEP) have demonstrated a significant reduction in the risk of falls and fall-related injuries in the elderly within community settings. Recent studies have strived to integrate technology into physical exercise programs, which is effective for adherence and overcoming barriers to exercise, as well as improving physical functioning. Objective: This study aims to assess the impact of the OEP on the functionality of home-dwelling elderly using a common technological platform. Particularly, the impact on muscle strength, balance, mobility, risk of falling, the perception of fear of falling, and the perception of the elderly regarding the ease of use of technology are being examined in this study. Methods: A quasi-experimental study (before and after; single group) will be conducted with male and female participants aged 65 years or older living at home in the district of Porto. Participants will be recruited through the network COLABORAR, with a minimum of 30 participants meeting the study inclusion and exclusion criteria. All participants will sign informed consent forms. The data collection instrument consists of sociodemographic and clinical variables (self-reported), functional evaluation variables, and environmental risk variables. The data collection tool integrates primary and secondary outcome variables. The primary outcome is gait (timed-up and go test; normal step). The secondary outcome variables are lower limb strength and muscle resistance (30-second chair stand test), balance (4-stage balance test), frequency of falls, functional capacity (Lawton and Brody - Portuguese version), fear of falling (Falls Efficacy Scale International - Portuguese version), usability of the technology (System Usability Scale - Portuguese version), and environmental risk variables (home fall prevention checklist for older adults). Technological solutions, such as the FallSensing Home application and Kallisto wearable device, will be used, which will allow the detection and prevention of falls. The intervention is characterized by conducting the OEP through a common technological platform 3 times a week for 8 weeks. Throughout these weeks, the participants will be followed up in person or by telephone contact by the rehabilitation nurse. Considering the COVID-19 outbreak, all guidelines from the National Health Service will be followed. The project was funded by InnoStars, in collaboration with the Local EIT Health Regional Innovation Scheme Hub of the University of Porto. Results: This study was approved on October 9, 2020 by the Ethics Committee of Escola Superior de Enfermagem do Porto (ESEP). The recruitment process was meant to start in October, but due to the COVID-19 pandemic, it was suspended. We expect to restart the study by the beginning of the third quarter of 2021. Conclusions: The findings of this study protocol will contribute to the design and development of future robust studies for technological tests in a clinical context. Trial Registration: ISRCTN 15895163; https://www.isrctn.com/ISRCTN15895163 International Registered Report Identifier (IRRID): PRR1-10.2196/25781

Screening diabetic retinopathy, a major cause of blindness, is time-consuming for ophthalmologists and has some constrains in achieving full coverage and attendance. The handheld fundus camera EyeFundusScope was recently developed to expand the scale of screening, drawing on images acquired in primary care and telescreening made by ophthalmologists or a computer-aided diagnosis (CADx) system. This study aims to assess the diagnostic accuracy of the interpretation of images captured using EyeFundusScope and perform its technical evaluation, including image quality, functionality, usability, and acceptance in a real-world clinical setting. Physicians and nurses without training in ophthalmology will use EyeFundusScope to take pictures of the retinas of patients with diabetes and the images will be classified for the presence or absence of diabetic retinopathy and image quality by a panel of ophthalmologists. A subgroup of patients will also be examined with the reference standard tabletop fundus camera. Screening results provided by the CADx system on images taken with EyeFundusScope will be compared against the ophthalmologists’ analysis of images taken with the tabletop fundus camera. Diagnostic accuracy measures with 95% confidence intervals (CIs) will be calculated for positive and negative test results. Proportion of each category of image quality will be presented. Usability and acceptance results will be presented qualitatively.

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

Background/Objectives: Digital health applications (DHAs) promise to improve disease self-management, but adherence remains suboptimal. We aimed to explore self-monitoring practices of rheumatic and musculoskeletal diseases (RMD) patients. A web-survey was conducted over 7 months including RMD patients to study their self-monitoring practices and the potential of DHAs. Methods: Health, sociodemographic, and technology adherence indicators were retrieved for comparison. Regression analyses and unsupervised profiling were performed to investigate multiple patient profiles. Results: From 228 responses gathered, most reported willingness to use DHAs to monitor their condition (78% agreement), although the majority rarely/never tracked symptoms (64%), often due to stable condition or no perceived value (62%). Of those tracking regularly, 52% used non-digital means. Participants with regular self-monitoring practices were more open to use a self-monitoring app (OR = 0.8 [0.6, 0.9]; p = 0.008) and be embedded in multidisciplinary care (OR = 1.4 [1.1, 1.6]; p < 0.001), but showed worse health status (g = 0.4; p = 0.006). Cluster analyses revealed three distinct groups of reasons for not tracking regularly (${\chi }^2$ = 174.4; p < 0.001), two characterised by perceived low disease activity. Conclusions: Effective use of DHAs remains limited and non-digital means prevail in symptom monitoring. Findings suggest that better patient engagement strategies and passive monitoring should be adopted in early development stages of DHAs for better long-term disease self-care.