First iteration of a User-Centered Design process to develop an in-bed leg press.

BACKGROUND: Physical inactivity is prevalent among hospitalized patients and the daytime spent lying should be utilised for exercise. However, implementing new interventions in hospitals' complex daily routines is difficult and requires a participatory approach. OBJECTIVE: Exploring clinical settings and clinicians' perspectives regarding exercise in hospitalized patients to gauge the potential of further development of an in-bed training device and to formulate development goals. METHODS: A User-Centered Design approach was employed, consisting of work shadowing and focus groups with physiotherapists and nurses. Content and network analyses of the focus group data were performed. Personas were then developed and used to create clinical scenarios. RESULTS: Some clinicians perceived in-bed exercise counterproductive, while others recognized potential for unsupervised training. The most important design characteristics appeared to be a small size, low weight and simplicity of use to facilitate storage, transportation, and administration, respectively. The scenarios revealed that the device's use could increase the physical activity time by 1.4%, although it would also increase the working time of clinicians. CONCLUSION: The study highlighted the difficulties in developing a usable training device but encouraged the authors to pursue their efforts under the strict condition of following the formulated development goals.

A User-Centered Data Visualization of Atherosclerotic Heart Disease Risk Factors.

High cholesterol levels significantly contribute to the risk of atherosclerotic cardiovascular disease (ACVD), with a notable portion of ischemic heart disease cases linked to elevated cholesterol levels. Effective graphical displays of lipid panel tests and other cardiac risk factors are crucial for quick and accurate data interpretation, enabling early intervention for individuals with hyperlipidemia. Applying design theories such as Gestalt and distributed cognitive theories is essential for creating user-centered graphical data displays in the context of cardiovascular (CV) risk factors. The proposed dashboard informed by these theories is expected to help healthcare providers better address cardiovascular disease (CVD), enhancing diagnosis, treatment, and prevention. Moreover, this approach may help alleviate clinical provider burnout, improve patient outcomes, and reduce provider stress, thus contributing to safer and more effective healthcare systems.

Friends, Family, and Food: Development of a Food Allergy Intervention, F3-App, for Children.

Objective: Despite a marked increase in the prevalence of pediatric IgE-mediated food allergy (FA) in recent decades, there is a dearth of age-appropriate management education and support tools for youth with FA. The purpose of this report is to detail our methods for intervention design and refinement of an interactive educational software program for school-aged children with FA. Methods: Development of the "Friends, Family and Food Application (F3-App)" employed an iterative, user-centered design approach with input from children with FA, their caregivers, and other key experts. Phase 1 (Prototype Development/Pilot Evaluation) involved family input on key themes and educational messages, development of a prototype, and pilot testing. Phase 2 (Full F3-App Development/Open Trial) included refinement and expansion of the prototype per advisory panel and end-user recommendations, followed by an open trial with additional iterative refinement. Results: Acceptability and credibility of the F3-App were rated highly by most participants. Relatively few technical challenges arose with F3-App installation or use. Follow up interviews with children and caregivers suggested that the F3-App was generally well-received, families found the content useful, and that it prompted family discussion about the child's FA management. Conclusions: User input is critical to developing family-friendly software to support management of pediatric chronic conditions. Interactive educational software can be a useful channel for children to practice skills and build confidence in disease self-management and to facilitate family communication regarding the stresses of FA management. Trial registration: ClinicalTrials.gov identifier: NCT05111938.

Applying a User-Centered Design Framework to Develop a Remote Research Assessment Protocol for a Randomized Clinical Trial for Toddlers with Early Autism Characteristics.

COVID-19 required many research teams to shift from in-person to remote assessments, which posed both procedural and theoretical challenges. While research has explored the utility of remote assessments for autism diagnosis from the perspective of families and clinicians, less is known about their application in clinical trials. This paper describes the development of a remote research assessment protocol for a randomized clinical trial focusing on the implementation of reciprocal imitation teaching (RIT) with toddlers in Part C early intervention. This project spans two phases. For Phase 1, our team developed and documented a series of steps utilizing user-centered design (UCD) strategies (e.g., recruiting potential users, creating a prototype, engaging in iterative development) for the purpose of redesigning an assessment protocol for a remote environment. For Phase 2, we examined preliminary outcomes of the redesign process. Primary end users (assessors) rated post-redesign usability and acceptability, while acceptability was examined using attrition data from secondary end users (family participants). Preliminary fidelity of implementation was also examined. The iterative redesign process allowed the research team to refine aspects of the assessment that ultimately led to promising preliminary ratings of usability, acceptability, and feasibility, as well as high fidelity. Preliminary data suggest that the redesigned assessment appears to be an acceptable, feasible, and usable tool for autism clinical trial research and that assessors can use it with fidelity. Further research is needed to examine the reliability and validity of the assessment, as well as implementation characteristics on a larger scale.

A Digital Sexual Health Education Web Application for Resource-Poor Regions in Kenya: Implementation-Oriented Case Study Using the Intercultural Research Model.

BACKGROUND: Developing a digital educational application focused on sexual health education necessitates a framework that integrates cultural considerations effectively. Drawing from previous research, we identified the problem and essential requirements to incorporate cultural insights into the development of a solution. OBJECTIVE: This study aims to explore the Solution Room of the self-established Intercultural Research Model, with a focus on creating a reusable framework for developing and implementing a widely accessible digital educational tool for sexual health. The study centers on advancing from a low-fidelity prototype (She!Masomo) to a high-fidelity prototype (We!Masomo), while evaluating its system usability through differentiation. This research contributes to the pursuit of Sustainable Development Goals 3, 4, and 5. METHODS: The research methodology is anchored in the Solution Room of the self-expanded Intercultural Research Model, which integrates cultural considerations. It uses a multimethod, user-centered design thinking approach, focusing on extensive human involvement for the open web-based application. This includes gathering self-assessed textual user feedback, conducting a System Usability Scale (SUS) analysis, and conducting 4 face-to-face semistructured expert interviews, following COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. RESULTS: Based on the identified limitations of the low-fidelity prototype, She!Masomo (SUS score 67), which were highlighted through textual user feedback (63/77) and prototype feature comparisons, iterative development and improvement were implemented. This process led to the creation of an enhanced high-fidelity prototype (We!Masomo). The improved effectiveness of the enhanced prototype was evaluated using the qualitative SUS analysis (82/90), resulting in a favorable score of 77.3, compared with the previous SUS score of 67 for the low-fidelity prototype. Highlighting the importance of accessible digital educational tools, this study conducted 4 expert interviews (4/4) and reported e-survey results following the CHERRIES (Checklist for Reporting Results of Internet E-Surveys) guideline. The digital educational platform, We!Masomo, is specifically designed to promote universal and inclusive free access to information. Therefore, the developed high-fidelity prototype was implemented in Kenya. CONCLUSIONS: The primary outcome of this research provides a comprehensive exploration of utilizing a case study methodology to advance the development of digital educational web tools, particularly focusing on cultural sensitivity and sensitive educational subjects. It offers critical insights for effectively introducing such tools in regions with limited resources. Nonetheless, it is crucial to emphasize that the findings underscore the importance of integrating culture-specific components during the design phase. This highlights the necessity of conducting a thorough requirement engineering analysis and developing a low-fidelity prototype, followed by an SUS analysis. These measures are particularly critical when disseminating sensitive information, such as sexual health, through digital platforms. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12905-023-02839-6.

Augmenting clinicians' analytical workflow through task-based integration of data visualizations and algorithmic insights: a user-centered design study.

OBJECTIVES: To understand healthcare providers' experiences of using GlucoGuide, a mockup tool that integrates visual data analysis with algorithmic insights to support clinicians' use of patientgenerated data from Type 1 diabetes devices. MATERIALS AND METHODS: This qualitative study was conducted in three phases. In Phase 1, 11 clinicians reviewed data using commercial diabetes platforms in a think-aloud data walkthrough activity followed by semistructured interviews. In Phase 2, GlucoGuide was developed. In Phase 3, the same clinicians reviewed data using GlucoGuide in a think-aloud activity followed by semistructured interviews. Inductive thematic analysis was used to analyze transcripts of Phase 1 and Phase 3 think-aloud activity and interview. RESULTS: 3 high level tasks, 8 sub-tasks, and 4 challenges were identified in Phase 1. In Phase 2, 3 requirements for GlucoGuide were identified. Phase 3 results suggested that clinicians found GlucoGuide easier to use and experienced a lower cognitive burden as compared to the commercial diabetes data reports that were used in Phase 1. Additionally, GlucoGuide addressed the challenges experienced in Phase 1. DISCUSSION: The study suggests that the knowledge of analytical tasks and task-specific visualization strategies in implementing features of data interfaces can result in tools that lower the perceived burden of engaging with data. Additionally, supporting clinicians in contextualizing algorithmic insights by visual analysis of relevant data can positively influence clinicians' willingness to leverage algorithmic support. CONCLUSION: Task-aligned tools that combine multiple data-driven approaches, such as visualization strategies and algorithmic insights, can improve clinicians' experience in reviewing device data.

What helps, what hinders?-Focus group findings on barriers and facilitators for mobile service robot use in a psychosocial group therapy for people with dementia.

Introduction: Many countries are facing a shortage of healthcare workers. Furthermore, healthcare workers are experiencing many stressors, resulting in psychological issues, impaired health, and increased intentions to leave the workplace. In recent years, different technologies have been implemented to lighten workload on healthcare workers, such as electronic patient files. Robotic solutions are still rather uncommon. To help with acceptance and actual use of robots their functionalities should correspond to the users' needs. Method: In the pilot study Care4All-Initial, we developed and field-tested applications for a mobile service robot in a psychosocial, multimodal group therapy for people with dementia. To guide the process and assess possible facilitators and barriers, we conducted a reoccurring focus group including people with dementia, therapists, professional caregivers as well as researchers from different disciplines with a user-centered design approach. The focus group suggested and reviewed applications and discussed ethical implications. We recorded the focus group discussions in writing and used content analysis. Results: The focus group discussed 15 different topics regarding ethical concerns that we used as a framework for the research project: Ethical facilitators were respect for the autonomy of the people with dementia and their proxies regarding participating and data sharing. Furthermore, the robot had to be useful for the therapists and attendees. Ethical barriers were the deception and possible harm of the people with dementia or therapists. The focus group suggested 32 different applications. We implemented 13 applications that centered on the robot interacting with the people with dementia and lightening the workload off the therapists. The implemented applications were facilitated through utilizing existing hard- and software and building on applications. Barriers to implementation were due to hardware, software, or applications not fitting the scope of the project. Discussion: To prevent barriers of robot employment in a group therapy for people with dementia, the robot's applications have to be developed sufficiently for a flawless and safe use, the use of the robot should not cause irritation or agitation, but rather be meaningful and useful to its users. To facilitate the development sufficient time, money, expertise and planning is essential.

A study on the formative usability testing for modular powered wheelchair.

The increasing prevalence of mobility impairments underscores the urgent need for accessible and affordable mobility aids. To overcome the mobility limitations of people with disabilities, there is an increasing need for the development of lightweight and portable powered wheelchairs that can be easily loaded. This study aimed to perform an early health technology assessment and a formative usability evaluation on a modular (detachable) powered wheelchair. It aimed to gauge device satisfaction among users, pinpoint areas for improvement, and detect any unforeseen errors to inform future development. Engaging 16 participants, including powered wheelchair users, healthcare professionals, and caregivers, the research evaluated the wheelchair's functionality in various scenarios, emphasizing safety, effectiveness, and convenience. Statistical analyses of task performance and satisfaction surveys highlighted that, while powered wheelchair users successfully completed tasks focusing on driving and power control, healthcare professionals and caregivers encountered difficulties with the wheelchair's assembly and disassembly. Despite general positivity, the surveys indicated mixed satisfaction levels regarding safety, validity, and convenience, with specific issues related to frame durability, seat comfort, and control mechanisms. These findings suggest that refining the wheelchair's design and addressing user concerns could significantly enhance satisfaction and mobility services. Future efforts will include a thorough review of an advanced prototype and further satisfaction assessments.

We believe that our study makes a significant contribution to the literature by addressing a critical gap in the understanding of user-centric design and usability testing for powered wheelchairs.By emphasizing the importance of early assessments and incorporating user feedback into the development process, our research offers practical insights for creating more accessible and user-friendly mobility solutions.This contribution is particularly relevant in the context of advancing assistive technology and improving the quality of life for individuals with disabilities.

A user-inspired mobility experience of the future: a qualitative investigation.

Wheelchair users (WCUs) face additional challenges than non-WCU to multi-tasking (i.e. open doors, cook, use a cell-phone) while navigating their environments. While assistive devices have attempted to provide WCUs with mobility solutions that enable multi-tasking capabilities, current devices have been developed without the input of end-users and have proven to be non-usable. More balanced approaches that integrate the end-users' voices may improve current assistive technology usability trends. This study sought to empathically understand the lived experience of WCUs, their needs towards a mobility device, and their perceptions towards hands-free mobility. Full-time WCUs and care providers participated in semi-structured interviews examining wheelchair use and perceptions towards current and future mobility devices. Thematic analysis was used to analyze interview data. 9 WCUs (aged 32.1 ± 7.0 years; wheelchair experience 17.9 ± 11.6 years) and five care providers (years caring for WCU 3.75 ± 0.96 years) participated in the study. The most common disability type was spinal cord injury (WCUs: n = 3; care providers: n = 3). Qualitative analysis revealed four key themes: (1) Current wheelchair usage, (2) WCU and care provider perspectives, (3) Future wheelchair, and (4) Hands-free wheelchair. Accordingly, participants desire bespoke, light-weight mobility devices that can through tight spaces, access uneven terrain, and free the hands during navigation. This study provides meaningful insight into the needs of WCUs and care providers that assistive technology innovators can use to develop more usable assistive technologies. Amongst study participants, the concept of a hands-free mobility device appears to be usable and desirable.

Integrating end-users' voices into the development of assistive technology may improve current usability trendsWheelchair users desire access to their hands and the ability to multi-task while navigating their wheelchairsThe development of a hands-free mobility device may profoundly improve the quality of life of wheelchair users.

A practical guide for selecting continuous monitoring wearable devices for community-dwelling adults.

Importance: The burgeoning landscape of wearable devices warrants a guide for the selection of devices. Existing guidelines and recommendations provide evaluation frameworks with theoretical principles but tend to lack a pragmatic application and systematic approach for device selection. While fitness trackers exemplify the convenience of wearable technologies, their selection for specific health monitoring purposes demands a nuanced understanding of varying functionalities and user compatibilities. Objective: The objective is to develop and present a practical guide for researchers, healthcare professionals, and device users to systematically select wearable devices for continuous monitoring in community-dwelling adults. Methods & results: Based on diverse sources, such as the United States Food and Drug Administration (FDA), the Clinical Trials Transformation Initiative (CTTI), the Electronic Patient-Reported Outcome (ePRO) Consortium, and comparative analyses of wearable technology performances from feasibility and usability studies, the guide incorporates five core criteria: continuous monitoring capability, device availability and suitability, technical performance (accuracy and precision), feasibility of use, and cost evaluation. The structured criteria can be applied in device selection as well as device evaluation. Conclusions: This practical guide provides a step-by-step solution for researchers, healthcare professionals, and device users to choose suitable wearable devices for continuous monitoring. It provides a comprehensive starting point, outlining how to effectively navigate the selection process for wearable devices amidst a plethora of similar options.

Development of a Novel Mobile Health App to Empower Young People With Type 1 Diabetes to Exercise Safely: Co-Design Approach.

BACKGROUND: Blood glucose management around exercise is challenging for youth with type 1 diabetes (T1D). Previous research has indicated interventions including decision-support aids to better support youth to effectively contextualize blood glucose results and take appropriate action to optimize glucose levels during and after exercise. Mobile health (mHealth) apps help deliver health behavior interventions to youth with T1D, given the use of technology for glucose monitoring, insulin dosing, and carbohydrate counting. OBJECTIVE: We aimed to develop a novel prototype mHealth app to support exercise management among youth with T1D, detail the application of a co-design process and design thinking principles to inform app design and development, and identify app content and functionality that youth with T1D need to meet their physical activity goals. METHODS: A co-design approach with a user-centered design thinking framework was used to develop a prototype mHealth app "acT1ve" during the 18-month design process (March 2018 to September 2019). To better understand and respond to the challenges among youth with diabetes when physically active, 10 focus groups were conducted with youth aged 13-25 years with T1D and parents of youth with T1D. Thereafter, we conducted participatory design workshops with youth to identify key app features that would support individual needs when physically active. These features were incorporated into a wireframe, which was critically reviewed by participants. A beta version of "acT1ve" was built in iOS and android operating systems, which underwent critical review by end users, clinicians, researchers, experts in exercise and T1D, and app designers. RESULTS: Sixty youth with T1D, 14 parents, 6 researchers, and 10 clinicians were engaged in the development of "acT1ve." acT1ve included key features identified by youth, which would support their individual needs when physically active. It provided advice on carbohydrates and insulin during exercise, information on hypoglycemia treatment, pre- and postexercise advice, and an educational food guide regarding exercise management. "acT1ve" contained an exercise advisor algorithm comprising 240 pathways developed by experts in diabetes and exercise research. Based on participant input during exercise, acT1ve provided personalized insulin and carbohydrate advice for exercise lasting up to 60 minutes. It also contains other features including an activity log, which displays a complete record of the end users' activities and associated exercise advice provided by the app's algorithm for later reference, and regular reminder notifications for end users to check or monitor their glucose levels. CONCLUSIONS: The co-design approach and the practical application of the user-centered design thinking framework were successfully applied in developing "acT1ve." The design thinking processes allowed youth with T1D to identify app features that would support them to be physically active, and particularly enabled the delivery of individualized advice. Furthermore, app development has been described in detail to help guide others embarking on a similar project. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001414101; https://tinyurl.com/mu9jvn2d.

Implementing a clinical decision support tool to increase early peanut introduction guidance.

BACKGROUND: General pediatric providers are the front line for early peanut introduction discussions, but many providers believe that they are ill-equipped to handle such discussions, as the guidelines have changed quickly. OBJECTIVE: We hypothesized that a clinical decision support (CDS) tool could improve discussions of peanut introduction. METHODS: CDS tools were designed by stakeholders, improved through usability testing, and integrated into the current note templates. On the basis of queries of electronic health records, we did a preperformance versus postperformance evaluation of conversations regarding peanut introduction, barriers to peanut introduction, and percentage of 12-month well-child checkups (WCCs) that resulted in successful introduction of peanut. Providers completed surveys before and after intervention to assess their awareness of early peanut introduction and comfort using the CDS tools. RESULTS: Providers' awareness of early peanut introduction guidelines increased from 17.8% to 66.7% after the CDS tool was implemented; 79.1% of the providers were comfortable using the tool. The CDS tool improved peanut introduction conversations at the 4-month WCC from 2.4% to 81.2%, at the 6-month WCC from 3.0% to 84.2%, and at the 12-month WCC from 2.7% to 82.9%. In all, 56.6% of families had a plan to introduce peanut at the 4-month WCC. Of those who did not have a plan, the most common barrier was the family's unawareness of the benefits of early peanut introduction. At the 12-month WCC, 62.8% of families had introduced peanut without concerns. CONCLUSION: A point-of-care CDS tool encouraged more discussions of early peanut introduction between general pediatric providers and all patients. CDS tools should be considered in quality improvement projects as an implementation method for the most up-to-date guidelines.

Co-designing a cardiac rehabilitation program with knowledge users for patients with cardiovascular disease from a remote area.

BACKGROUND: Cardiovascular disease is the leading cause of death worldwide. Cardiac rehabilitation (CR) programs are recognized as effective in reducing the burden of cardiovascular disease. However, CR programs are offered inequitably across regions and are available in less than 15% of remote areas worldwide. The main goal of this study was to design a CR program adapted to the contexts of remote areas to improve the service offered to patients. METHODS: We used an iterative user-centered design approach to understand the user context and services offered in cardiac rehabilitation in remote areas. We conducted two co-design processes with knowledge users in two remote regions. Two advisory committees were created in each of these regions, comprising managers (n = 6), healthcare professionals (n = 12) and patients (n = 2). We utilized the BACPR guidelines and the Hautes Autorités de santé operational model to support data collection in coding sessions to develop the CR program. We conducted four cycles of co-design with each of the committees to develop the cardiac rehabilitation program. Qualitative data were analyzed iteratively after each cycle. RESULTS: The co-design process resulted in developing a prototype cardiac rehabilitation program similar in both regions. It is based on a contextualized six-phase pathway of care designed for remote regions. For each phase 0 to 6 of the care pathway, knowledge users were asked to describe how to offer these phases in remote areas. Participants made structural changes to phases 0, 2, 3 and 4 in order to overcome staffing shortages in remote areas. These changes make it possible to decentralize cardiac rehabilitation expertise away from specialized centers, to ensure equity of service across the territory. Therapeutic patient education was integrated into phase 4 to meet patients' needs. Participants suggested that three follow-up offerings could come from nursing services to increase access to the cardiac rehabilitation program (primary care, home care, special chronic disease programs) in patients' home communities. CONCLUSION: The co-design process enables us to meet the needs of remote regions in program development. This final program can be the subject of future implementation research.

Smartwatch-Based Interventions for People With Dementia: User-Centered Design Approach.

BACKGROUND: Assistive technologies can help people living with dementia maintain their everyday activities. Nevertheless, there is a gap between the potential and use of these materials. Involving future users may help close this gap, but the impact on people with dementia is unclear. OBJECTIVE: We aimed to determine if user-centered development of smartwatch-based interventions together with people with dementia is feasible. In addition, we evaluated the extent to which user feedback is plausible and therefore helpful for technological improvements. METHODS: We examined the interactions between smartwatches and people with dementia or people with mild cognitive impairment. All participants were prompted to complete 2 tasks (drinking water and a specific cognitive task). Prompts were triggered using a smartphone as a remote control and were repeated up to 3 times if participants failed to complete a task. Overall, 50% (20/40) of the participants received regular prompts, and 50% (20/40) received intensive audiovisual prompts to perform everyday tasks. Participants' reactions were observed remotely via cameras. User feedback was captured via questionnaires, which included topics like usability, design, usefulness, and concerns. The internal consistency of the subscales was calculated. Plausibility was also checked using qualitative approaches. RESULTS: Participants noted their preferences for particular functions and improvements. Patients struggled with rating using the Likert scale; therefore, we assisted them with completing the questionnaire. Usability (mean 78 out of 100, SD 15.22) and usefulness (mean 9 out of 12) were rated high. The smartwatch design was appealing to most participants (31/40, 76%). Only a few participants (6/40, 15%) were concerned about using the watch. Better usability was associated with better cognition. The observed success and self-rated task comprehension were in agreement for most participants (32/40, 80%). In different qualitative analyses, participants' responses were, in most cases, plausible. Only 8% (3/40) of the participants were completely unaware of their irregular task performance. CONCLUSIONS: People with dementia can have positive experiences with smartwatches. Most people with dementia provided valuable information. Developing assistive technologies together with people with dementia can help to prioritize the future development of functional and nonfunctional features.

Supporting Teams with Designing for Dissemination and Sustainability: the Design, Development, and Usability of a Digital Interactive Platform.

Background: The use of Designing for Dissemination and Sustainability (D4DS) principles and methods can support the development of research products (interventions, tools, findings) to match well with the needs and context of the intended audience and setting. D4DS principles and methods are not well-known or used during clinical and public health research; research teams would benefit from applying D4DS. This paper presents the development of a new digital platform for teams to learn and apply a D4DS process to their work. Methods: A user-centered design (UCD) approach engaged users (n=14) and an expert panel (n=6) in an iterative design process from discovery to prototyping and testing. We led five design sessions using Zoom and Figma software over a 5-month period. Users (71% academics; 29% practitioners) participated in at least 2 sessions. Following design sessions, feedback from users were summarized and discussed to generate design decisions. A prototype was then built and heuristically tested with 11 users who were asked to complete multiple tasks within the platform while verbalizing their decision-making using the 'think aloud' procedure. The System Usability Scale (SUS) was administered at the end of each testing session. After refinements to the platform were made, usability was reassessed with 7 of 11 same users to examine changes. Results: The interactive digital platform (the D4DS Planner) has two main components: 1) the Education Hub (e.g., searchable platform with literature, videos, websites) and 2) the Action Planner. The Action Planner includes 7 interactive steps that walk users through a set of activities to generate a downloadable D4DS action plan for their project. Participants reported that the prototype tool was moderately usable (SUS=66) but improved following refinements (SUS=71). Conclusions: This is a first of its kind tool that supports research teams in learning about and explicitly applying D4DS to their work. The use of this publicly available tool may increase the adoption, impact, and sustainment of a wide range of research products. The use of UCD yielded a tool that is easy to use. The future use and impact of this tool will be evaluated, and the tool will continue to be refined and improved.

Multi-stage optimization strategy based on contextual analysis to create M-health components for case management model in breast cancer transitional care: the CMBM study as an example.

BACKGROUND: None of the early M-Health applications are designed for case management care services. This study aims to describe the process of developing a M-health component for the case management model in breast cancer transitional care and to highlight methods for solving the common obstacles faced during the application of M-health nursing service. METHODS: We followed a four-step process: (a) Forming a cross-functional interdisciplinary development team containing two sub-teams, one for content development and the other for software development. (b) Applying self-management theory as the theoretical framework to develop the M-health application, using contextual analysis to gain a comprehensive understanding of the case management needs of oncology nursing specialists and the supportive care needs of out-of-hospital breast cancer patients. We validated the preliminary concepts of the framework and functionality of the M-health application through multiple interdisciplinary team discussions. (c) Adopting a multi-stage optimization strategy consisting of three progressive stages: screening, refining, and confirmation to develop and continually improve the WeChat mini-programs. (d) Following the user-centered principle throughout the development process and involving oncology nursing specialists and breast cancer patients at every stage. RESULTS: Through a continuous, iterative development process and rigorous testing, we have developed patient-end and nurse-end program for breast cancer case management. The patient-end program contains four functional modules: "Information", "Interaction", "Management", and "My", while the nurse-end program includes three functional modules: "Consultation", "Management", and "My". The patient-end program scored 78.75 on the System Usability Scale and showed a 100% task passing rate, indicating that the programs were easy to use. CONCLUSIONS: Based on the contextual analysis, multi-stage optimization strategy, and interdisciplinary team work, a WeChat mini-program has been developed tailored to the requirements of the nurses and patients. This approach leverages the expertise of professionals from multiple disciplines to create effective and evidence-based solutions that can improve patient outcomes and quality of care.

Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.

BACKGROUND: Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the recommended first-line treatment. However, multiple individual and institutional barriers impede women's access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, although these technologies have not yet been leveraged at scale. OBJECTIVE: The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success. METHODS: This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis. RESULTS: Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated. CONCLUSIONS: This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.

Improving the Acceptability and Implementation of Information and Communication Technology-Based Health Care Platforms for Older People With Dementia or Parkinson Disease: Qualitative Study Results of Key Stakeholders.

BACKGROUND: The management of neurodegenerative diseases (NDDs) in older populations is usually demanding and involves care provision by various health care services, resulting in a greater burden on health care systems in terms of costs and resources. The convergence of various health services within integrated health care models, which are enabled and adopted jointly with information and communication technologies (ICTs), has been identified as an effective alternative health care solution. However, its widespread implementation faces formidable challenges. Both the development and implementation of integrated ICTs are linked to the collaboration and acceptance of different groups of stakeholders beyond patients and health care professionals, with reported discrepancies in the needs and preferences among these groups. OBJECTIVE: Complementing a previous publication, which reported on the needs and requirements of end users in the development of the European Union-funded project PROCare4Life (Personalized Integrated Care Promoting Quality of Life for Older People), this paper aimed to report on the opinions of other key stakeholders from various fields, including academia, media, market, and decision making, for improving the acceptability and implementation of an integrated ICT-based health care platform supporting the management of NDDs. METHODS: The study included 30 individual semistructured interviews that took place between June and August 2020 in 5 European countries (Germany, Italy, Portugal, Romania, and Spain). Interviews were mostly conducted online, except in cases where participants requested to be interviewed in person. In these cases, COVID-19 PROCare4Life safety procedures were applied. RESULTS: This study identified 2 themes and 5 subthemes. User engagement, providing training and education, and the role played by the media were identified as strategic measures to ensure the acceptability of ICT-based health care platforms. Sustainable funding and cooperation with authorities were foreseen as additional points to be considered in the implementation process. CONCLUSIONS: The importance of the user-centered design approach in ensuring the involvement of users in the development of ICT-based platforms has been highlighted. The most common challenges that hinder the acceptability and implementation of ICT-based health care platforms can be addressed by creating synergies among the efforts of users, academic stakeholders, developers, policy makers, and decision makers. To support future projects in developing ICT-based health care platforms, this study outlined the following recommendations that can be integrated when conducting research on users' needs: (1) properly identify the particular challenges faced by future user groups without neglecting their social and clinical contexts; (2) iteratively assess the digital skills of future users and their acceptance of the proposed platform; (3) align the functionalities of the ICT platform with the real needs of future users; and (4) involve key stakeholders to guide the reflection on how to implement the platform in the future. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/22463.

Introducing a Remote Patient Monitoring Usability Impact Model to Overcome Challenges.

Telehealth and remote patient monitoring (RPM), in particular, have been through a massive surge of adoption since 2020. This initiative has proven potential for the patient and the healthcare provider in areas such as reductions in the cost of care. While home-use medical devices or wearables have been shown to be beneficial, a literature review illustrates challenges with the data generated, driven by limited device usability. This could lead to inaccurate data when an exam is completed without clinical supervision, with the consequence that incorrect data lead to improper treatment. Upon further analysis of the existing literature, the RPM Usability Impact model is introduced. The goal is to guide researchers and device manufacturers to increase the usability of wearable and home-use medical devices in the future. The importance of this model is highlighted when the user-centered design process is integrated, which is needed to develop these types of devices to provide the proper user experience.

Expert review of child and caregiver critiques of a therapeutic guided imagery therapy mobile application targeting disorders of gut-brain interaction in children.

Background: A guided imagery therapy mobile application (GIT App) is a novel platform for treating children with disorders of gut-brain interaction (DGBI). Previous feedback from child/caregiver dyads suggested modifications for our App prototype. However, their feedback had the potential to affect the intervention's efficacy. Thus, we aimed to have their critiques vetted by relevant experts prior to further App refinement. Objective: Compare expert reviews of the GIT App with end-users' (i.e., child/caregiver dyads') feedback. Methods: This mixed-methods study with experts included a hands-on App evaluation, a survey assessing usability, and focus groups comparing their perspectives with those previously provided by end-users. Results: Eight medical and technology experts were enrolled. Their average usability survey score of the GIT App was 69.0 ± 27.7, which was marginally above the 50th percentile. While the expert and end-user usability assessments were generally favorable, both groups agreed that the App's reminder notification feature location was not intuitive, detracting from its usability. Experts agreed with end-users that the App's aesthetics were acceptable and suggested increasing icon and font sizes. Like the end-users, the experts did not achieve consensus regarding the ideal session length or inclusion of background sounds and screen animations. Lastly, the experts agreed with end-users that gamification techniques (e.g., gift cards and virtual badges) would promote user engagement. Conclusion: An expert review of our therapeutic App revealed findings consistent with end-users and provided insight for modifying the interface and GIT sessions. Based on this experience, we recommend expert vetting of end-user suggestions as a routine checkpoint when developing therapeutic Apps.