Measurement Equivalence of Standard and Zoom-Enabled Electronic Clinical Outcome Assessments: Implications for Patient Accessibility in Clinical Trials.

OBJECTIVES: Diversity and inclusion in clinical trials remains an important topic, particularly for participants with disabilities such as vision impairment. With advances in smartphone and tablet technologies, and their increasing use in clinical trials, accessibility features such as "pinch-to-zoom" are now at our fingertips. However, implementing such accessibility features when collecting electronic clinical outcomes assessments (eCOA) does not come without risks and must be designed with careful consideration and scientifically tested to ensure no impact to data integrity. Therefore, the objectives of this study were to determine the measurement equivalence of an eCOA questionnaire with and without a zoom accessibility feature and test its usability. METHODS: An eCOA app with a zoom accessibility feature was designed following industry standards for eCOA best design. Participants (n=53) with chronic or recent pain completed a questionnaire with standard response scales (verbal rating scale [VRS], numerical rating scale [NRS], visual analog scale [VAS]), with and without the zoom accessibility feature enabled, in a randomized crossover design. Intraclass Correlation Coefficients (ICCs) were determined. A subset of participants (n=10) with vision impairment participated in a usability testing interview. RESULTS: The ICC analysis showed high agreement (0.894-0.982) between zoomed and non-zoomed completions of the VRS, NRS and VAS. Participant usability testing showed good ease of use, ability to read the screen, and usefulness of the zoom feature, especially when not wearing corrective measures for vision impairment. CONCLUSIONS: These findings support the use of a specially designed eCOA zoom accessibility feature for use in clinical trials.

Electronic Patient-Reported Outcomes in Hidradenitis Suppurativa: Content Validity and Usability of the Electronic Hidradenitis Suppurativa Symptom Daily Diary, Hidradenitis Suppurativa Symptom Questionnaire, and Hidradenitis Suppurativa Quality of Life Questionnaire.

BACKGROUND: Hidradenitis suppurativa (HS), a chronic skin condition that causes pain and physical dysfunction, can impact significantly on quality of life. Disease-specific tools have been designed to assess the impact of HS on patients, including the HS Symptom Daily Diary (HSSDD), the HS Symptom Questionnaire (HSSQ), and the HS Quality of Life (HiSQOL©) questionnaire, which have been developed into electronic instruments (eHSSDD, eHSSQ, and eHiSQOL©). OBJECTIVES: The objective of this study was to establish the content validity of the electronic version of the HSSDD and HSSQ, and the acceptability and usability of the HSSDD, HSSQ, and HiSQOL©, using concept elicitation and cognitive debriefing interviews. METHODS: This was a non-interventional qualitative video interview study involving participants aged ≥18 years with moderate to severe HS recruited from a single clinical site in the USA. Interviews gathered feedback on participants' symptom experience, followed by training and completion of the eHSSDD, eHSSQ, and eHiSQOL© questionnaires on electronic handheld devices. Participants were then interviewed on the content of the eHSSDD and eHSSQ and the acceptability and usability of all three instruments. Interviews were transcribed and qualitatively analysed. RESULTS: Twenty participants with moderate to severe HS (median age: 41.5 [range: 20.0-64.0]; n = 16/20 female) were included. All participants found the eHSSDD, eHSSQ, and eHiSQOL© instructions clear and described the instruments as "easy", "simple" and "self-explanatory". Overall understanding of individual items within the eHSSDD and eHSSQ was high; however, 6/20 participants had difficulty in understanding the average skin pain item in the eHSSDD. All participants were able to accurately recall their symptoms within the recall periods of the eHSSDD and eHSSQ, although 4/20 participants found the 24-h recall period of the eHSSDD limiting. Completion time was quick across all instruments, and usability was high, with the majority of participants reporting no difficulty in completing questionnaires on electronic devices. CONCLUSION: The concepts covered in the eHSSDD and eHSSQ are relevant and important to patients, supporting their content validity. The findings also provide evidence of acceptability and usability of the eHSSDD, eHSSQ, and eHiSQOL©. A limitation was that all participants were recruited from a single site, which may have introduced selection bias and thus limited the generalisability of results.

Promoting vigorous intermittent lifestyle physical activity (vilpa) in middle-aged adults: an evaluation of the movsnax mobile app.

BACKGROUND: Most adults fail to meet the moderate to vigorous physical activity-based recommendations needed to maintain or improve health. Vigorous Intermittent Lifestyle Physical Activity (VILPA) refers to short (1-2 min) high-intensity activities that are integrated into activities of daily living. VILPA has shown strong potential to improve health and addresses commonly reported barriers to physical activity. However, it is unknown how VILPA can best be promoted among the adult population. This study aimed to evaluate the usability, user engagement, and satisfaction of a mobile application (MovSnax) designed to promote VILPA. METHODS: A concurrent mixed methods design was used. It comprised four parts. Part A was a survey with n = 8 mHealth and physical activity experts who had used the app over 7-10 days. Part B was think-aloud interviews with n = 5 end-users aged 40-65 years old. Part C was a survey with a new group of 40-65-year-old end-users (n = 35) who had used the MovSnax app over 7-10 days. Part D was semi-structured interviews with n = 18 participants who took part in Part C. Directed content analysis was used to analyze the results from Parts A, B, and D, and descriptive statistics were used to analyze findings from Part C. RESULTS: Participants reported positive views on the MovSnax app for promoting VILPA but also identified usability issues such as unclear purpose, difficulties in manual data entry, and limited customization options. Across the different data collections, they consistently emphasized the need for more motivational features, clearer feedback, and gamification elements to enhance engagement. Quantitative assessment showed satisfactory scores on objective measures but lower ratings on subjective aspects, possibly due to unfamiliarity with the VILPA concept and/or technical barriers. CONCLUSIONS: The MovSnax app, tested in the present study, is the world's first digital tool aimed specifically at increasing VILPA. The findings of the present study underscore the need for further app refinement, focusing on clarifying its purpose and instructions, boosting user engagement through personalization and added motivational elements, enhancing accuracy in detecting VILPA bouts, implementing clearer feedback mechanisms, expanding customization choices (such as font size and comparative data), and ensuring transparent and meaningful activity tracking.

Evaluation of a digital patient education programme in patients with coronary artery disease, a survey-based study.

INTRODUCTION: Patient education programmes focusing on risk factor modification and lifestyle changes are well established as part of cardiac rehabilitation in patients with coronary artery disease (CAD). As participation rates are low, digital patient education programmes (DPE) are interesting alternatives to increase access. Understanding patients' perceptions of DPE are important in terms of successful implementation in clinical practice but are not well known. Therefore, the aim of this study was to assess patients' perceptions of using a DPE in terms of end-user acceptance and usability, perceived significance for lifestyle changes and secondary preventive goal fulfilment in patients with CAD. METHODS: This was a cross-sectional survey-based study. The survey was distributed to all 1625 patients with acute coronary syndrome or chronic CAD with revascularisation, who were registered users of the DPE between 2020 and 2022 as part of cardiac rehabilitation. The survey contained 64 questions about e.g., acceptance and usability, perceived significance for making lifestyle changes and secondary preventive goal fulfilment. Patients who had never logged in to the DPE received questions about their reasons for not logging in. Data were analysed descriptively. RESULTS: A total of 366 patients (mean age: 69.1 ± 11.3 years, 20% female) completed the survey and among those 207 patients (57%) had used the DPE. Patients reported that the DPE was simple to use (80%) and improved access to healthcare (67-75%). A total of 69% of the patients were generally satisfied with the DPE, > 60% reported that the DPE increased their knowledge about secondary preventive treatment goals and approximately 60% reported having a healthy lifestyle today. On the other hand, 35% of the patients would have preferred a hospital-based education programme. Among the 159 patients (43%) who had never used the DPE, the most reported reason was a perceived need for more information about how to use the DPE (52%). CONCLUSIONS: This study shows an overall high level of patient acceptance and usability of the DPE, which supports its continued development and long-term role in cardiac rehabilitation in patients with CAD. Future studies should assess associations between participation in the DPE and clinical outcomes, such as secondary preventive goal fulfilment and hospitalisation.

Using Quality Improvement as a Mechanism for Fostering Partnerships and Promoting Equity in a Health System Change Model.

PURPOSE: Quality improvement (QI) processes provide a framework for systematically examining target outcomes and what changes can be made to result in improvement and ensure equity. We present a case study of how QI processes were used as a means of partnership building to enhance equity in designing materials for a Medicaid pilot program, North Carolina Integrated Care for Kids (NC InCK). DESCRIPTION: The NC InCK model addresses social determinants of health by providing structured care integration across core child health and social service areas and using an alternative payment model to incentivize high quality child outcomes. During the two-year planning period prior to the NC InCK model launch, we used Plan-Do-Study-Act (PDSA) cycles to conduct usability testing as a QI strategy for a component of the NC InCK model: the Shared Action Plan (SAP). ASSESSMENT: We conducted usability testing with four Family Council members, nine care managers, and one physician. Participants reviewed the SAP and provided feedback via a survey. After reviewing feedback with InCK leadership and the Family Council, we implemented recommendations that led to a SAP that uses clear and accessible language, that highlights family strengths and family-identified goals, and that is distinct from other care management plans. CONCLUSION: Usability testing forced refinement of materials before NC InCK launched, created opportunities for building and enhancing community partnerships and promoted equity within the NC InCK team and Family Council by considering multiple perspectives when deciding on SAP revisions.

Usability Evaluation Methods Used in Electronic Discharge Summaries: Literature Review.

BACKGROUND: With the widespread adoption of digital health records, including electronic discharge summaries (eDS), it is important to assess their usability in order to understand whether they meet the needs of the end users. While there are established approaches for evaluating the usability of electronic health records, there is a lack of knowledge regarding suitable evaluation methods specifically for eDS. OBJECTIVE: This literature review aims to identify the usability evaluation approaches used in eDS. METHODS: We conducted a comprehensive search of PubMed, CINAHL, Web of Science, ACM Digital Library, MEDLINE, and ProQuest databases from their inception until July 2023. The study information was extracted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). We included studies that assessed the usability of eDS, and the systems used to display eDS. RESULTS: A total of 12 records, including 11 studies and 1 thesis, met the inclusion criteria. The included studies used qualitative, quantitative, or mixed methods approaches and reported the use of various usability evaluation methods. Heuristic evaluation was the most used method to assess the usability of eDS systems (n=7), followed by the think-aloud approach (n=5) and laboratory testing (n=3). These methods were used either individually or in combination with usability questionnaires (n=3) and qualitative semistructured interviews (n=4) for evaluating eDS usability issues. The evaluation processes incorporated usability metrics such as user performance, satisfaction, efficiency, and impact rating. CONCLUSIONS: There are a limited number of studies focusing on usability evaluations of eDS. The identified studies used expert-based and user-centered approaches, which can be used either individually or in combination to identify usability issues. However, further research is needed to determine the most appropriate evaluation method which can assess the fitness for purpose of discharge summaries.

Researched Apps Used in Dementia Care for People Living With Dementia and Their Informal Caregivers: Systematic Review on App Features, Security, and Usability.

BACKGROUND: Studies have shown that mobile apps have the potential to serve as nonpharmacological interventions for dementia care, improving the quality of life of people living with dementia and their informal caregivers. However, little is known about the needs for and privacy aspects of these mobile apps in dementia care. OBJECTIVE: This review seeks to understand the landscape of existing mobile apps in dementia care for people living with dementia and their caregivers with respect to app features, usability testing, privacy, and security. METHODS: ACM Digital Library, Cochrane Central Register of Controlled Trials, Compendex, Embase, Inspec, Ovid MEDLINE, PsycINFO, and Scopus were searched. Studies were included if they included people with dementia living in the community, their informal caregivers, or both; focused on apps in dementia care using smartphones or tablet computers; and covered usability evaluation of the app. Records were independently screened, and 2 reviewers extracted the data. The Centre for Evidence-Based Medicine critical appraisal tool and Mixed Methods Appraisal Tool were used to assess the risk of bias in the included studies. Thematic synthesis was used, and the findings were summarized and tabulated based on each research aim. RESULTS: Overall, 44 studies were included in this review, with 39 (89%) published after 2015. In total, 50 apps were included in the study, with more apps developed for people living with dementia as end users compared with caregivers. Most studies (27/44, 61%) used tablet computers. The most common app feature was cognitive stimulation. This review presented 9 app usability themes: user interface, physical considerations, screen size, interaction challenges, meeting user needs, lack of self-awareness of app needs, stigma, technological inexperience, and technical support. In total, 5 methods (questionnaires, interviews, observations, logging, and focus groups) were used to evaluate usability. There was little focus on the privacy and security aspects, including data transfer and protection, of mobile apps for people living with dementia. CONCLUSIONS: The limitations of this review include 1 reviewer conducting the full-text screening, its restriction to studies published in English, and the exclusion of apps that lacked empirical usability testing. As a result, there may be an incomplete representation of the available apps in the field of dementia care. However, this review highlights significant concerns related to the usability, privacy, and security of existing mobile apps for people living with dementia and their caregivers. The findings of this review provide a valuable framework to guide app developers and researchers in the areas of privacy policy development, app development strategies, and the importance of conducting thorough usability testing for their apps. By considering these factors, future work in this field can be advanced to enhance the quality and effectiveness of dementia care apps. TRIAL REGISTRATION: PROSPERO CRD42020216141; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=216141. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1159/000514838.

Development and usability evaluation of a mHealth application for albinism self-management.

BACKGROUND: Reduced or absence of melanin poses physical, social, and psychological challenges to individuals with albinism. Mobile health (mHealth) applications have the potential to improve the accessibility of information and services while reducing time and costs. This study aimed to develop and evaluate a mHealth application for self-management of albinism. METHODS: This applied study was conducted in two stages (development and evaluation) in 2022. Initially, the functional requirements were determined, and the conceptual model of the application was then developed using Microsoft Visio 2021. In the second phase, the application was evaluated using the Mobile Application Usability Questionnaire (MAUQ) involving patients with albinism to reflect their views on the usability of the application. RESULTS: The key capabilities of the application included: reminders, alerts, educational content, useful links, storage and exchange of images of skin lesions, specialist finder, and notifications for albinism-relevant events. Twenty-one users with albinism participated in the usability testing of the application. The users were predominantly satisfied with the application (5.53 ± 1.10; Max: 7.00). CONCLUSIONS: The findings of this study suggest that the developed mobile application could assist individuals with albinism to effectively manage their condition by considering the users' requirements and services that the application should deliver.

A WeChat applet-based national remote emergency system for malignant hyperthermia in China: a usability study.

BACKGROUND: Malignant hyperthermia (MH) is a rare anesthetic emergency with a high mortality rate in China. We developed a WeChat applet-based National Remote Emergency System for Malignant Hyperthermia (MH-NRES) to provide a real-time emergency system to help Chinese anesthesiologists deal with MH crises. However, it is imperative that close attention should be paid to the usability of the applet. PURPOSE: The objectives of this study were to (1) evaluate the usability of the applet-based MH-NRES for anesthesiologists; and (2) to test the validity and reliability of a modified mHealth app usability questionnaire. METHODS: A modified User Version of the Mobile Application Rating Scale (uMARS) was designed. Together with System Usability Scale (SUS) and Post-Study System Usability Questionnaire (PSSUQ), another two well-validated questionnaires, uMARS were then used to evaluate the usability of MH-NRES. The Cronbach alpha of the total score and the subscales of uMARS was calculated to evaluate the internal consistency. The correlation coefficients among three questionnaires were calculated. RESULTS: In this study, 118 anesthesiologists provided responses to the questionnaire. The overall mean uMARS score was 4.43 ± 0.61, which ranged from 3 to 5. The mean PSSUQ score were in good to excellent range with mean of 6.02 ± 0.97, which ranged from 3.19 to 7. The overall SUS score was 76.0 ± 17.6, which ranged from 45 to 100. The total uMARS score had excellent internal consistency (Cronbach alpha = 0.984). uMARS and its subscales were strongly correlated with PSSUQ (coefficient 0.758-0.819, P < 0.001) and SUS (coefficient 0.535-0.561, P < 0.001), respectively. CONCLUSIONS: Data obtained from the usability evaluation questionnaires in this study indicated a high quality of the MH-NRES on the ease of use, satisfaction and perceived usefulness, which suggest this system might be a useful tool for anesthesiologists' education and management of MH crises. Future feedback from high-fidelity simulation and clinical scenarios are need for further usability evaluation of this system.

A qualitative study to elicit user requirements for lower limb wearable exoskeletons for gait rehabilitation in spinal cord injury.

OBJECTIVE: We aim to determine a comprehensive set of requirements, perceptions, and expectations that people with spinal cord injury (SCI) and the clinicians in charge of their rehabilitation have regarding the use of wearable robots (WR) for gait rehabilitation. BACKGROUND: There are concerns due to the limited user acceptance of WR for gait rehabilitation. Developers need to emphasize understanding the needs and constraints of all stakeholders involved, including the real-life dynamics of rehabilitation centers. METHODS: 15 people with SCI, 9 without experience with WR and 6 with experience with these technologies, and 10 clinicians from 3 rehabilitation centers in Spain were interviewed. A directed content analysis approach was used. RESULTS: 78 codes grouped into 9 categories (physical results, usability, psychology-related codes, technical characteristics, activities, acquisition issues, context of use, development of the technologies and clinical rehabilitation context) were expressed by at least 20% of the users interviewed, of whom 16 were not found in the literature. The agreement percentage between each group and subgroup included in the study, calculated as the number of codes that more than 20% of both groups expressed, divided over the total amount of codes any of those two groups agreed on (≥ 20%), showed limited agreement between patients and clinicians (50.00%) and between both types of patients (55.77%). The limited accessibility and availability of lower limb exoskeletons for gait rehabilitation arose in most of the interviews. CONCLUSIONS: The limited agreement percentage between patients and clinicians indicates that including both types of users in the design process of these technologies is important, given that their requirements are complementary. Engaging users with prior technology experience is recommended, as they often exhibit strong internal consensus and articulate well-defined requirements. This study adds up the knowledge available in the literature and the new codes found in our data, which enlighten important aspects that ought to be addressed in the field to develop technologies that respond to users' needs, are usable and feasible to implement in their intended contexts. APPLICATION: The set of criteria summarized in our study will be useful to guide the design, development, and evaluation of WR for gait rehabilitation to meet user's needs and allow them to be implemented in their intended context of use.

A Comparative Study of the Typing Performance of Two Mid-Air Text Input Methods in Virtual Environments.

Inputting text is a prevalent requirement among various virtual reality (VR) applications, including VR-based remote collaboration. In order to eliminate the need for complex rules and handheld devices for typing within virtual environments, researchers have proposed two mid-air input methods-the trace and tap methods. However, the specific impact of these input methods on performance in VR remains unknown. In this study, typing tasks were used to compare the performance, subjective report, and cognitive load of two mid-air input methods in VR. While the trace input method was more efficient and novel, it also entailed greater frustration and cognitive workload. Fortunately, the levels of frustration and cognitive load associated with the trace input method could be reduced to the same level as those of the tap input method via familiarity with VR. These findings could aid the design of virtual input methods, particularly for VR applications with varying text input demands.

Software Usability Testing Using EEG-Based Emotion Detection and Deep Learning.

It is becoming increasingly attractive to detect human emotions using electroencephalography (EEG) brain signals. EEG is a reliable and cost-effective technology used to measure brain activities. This paper proposes an original framework for usability testing based on emotion detection using EEG signals, which can significantly affect software production and user satisfaction. This approach can provide an in-depth understanding of user satisfaction accurately and precisely, making it a valuable tool in software development. The proposed framework includes a recurrent neural network algorithm as a classifier, a feature extraction algorithm based on event-related desynchronization and event-related synchronization analysis, and a new method for selecting EEG sources adaptively for emotion recognition. The framework results are promising, achieving 92.13%, 92.67%, and 92.24% for the valence-arousal-dominance dimensions, respectively.

User Experiences of Well-Being Chatbots.

OBJECTIVE: The current paper conducted two parallel studies to explore user experiences of well-being conversational agents (CAs) and identify important features for engagement. BACKGROUND: Students transitioning into university life take on greater responsibility, yet tend to sacrifice healthy behaviors to strive for academic and financial gain. Additionally, students faced an unprecedented pandemic, leading to remote courses and reduced access to healthcare services. One tool designed to improve healthcare accessibility is well-being CAs. CAs have addressed mental health support in the general population but have yet to address physical well-being support and accessibility to those in disadvantaged socio-economic backgrounds where healthcare access is further limited. METHOD: Study One comprised a thematic analysis of mental health applications featuring CAs from the public forum, Reddit. Study Two explored emerging usability themes of an SMS-based CA designed to improve accessibility to well-being services alongside a commercially available CA, Woebot. RESULTS: Study One identified several themes, including accessibility and availability, communication style, and anthropomorphism as important features. Study Two identified themes such as user response modality, perceived CA role, question specificity, and conversation flow control as critical for user engagement. CONCLUSION: Various themes emerged from individuals' experiences regarding CA features, functionality, and responses. The mixed experiences relevant to the communication and conversational styles between the CA and the user suggest varied motivations for using CAs for mental and physical well-being. APPLICATION: Practical recommendations to encourage continued use include providing dynamic response modalities, anthropomorphizing the chatbot, and calibrating expectations early.

One Website to Gather them All: Usability Testing of the New German SKin Cancer INFOrmation (SKINFO) Website-A Mixed-methods Approach.

Skin cancer patients increasingly search the internet to acquire disease-related information. However, information on the internet may be misleading. Recently, SKINFO has been launched, a website exclusively created for German-speaking skin cancer patients providing information as well as additional resources of verified quality. Here, we describe the results of the first usability test of SKINFO using a mixed-methods approach. Ten adult patients with skin cancer were recruited for usability testing in the skin cancer units of the University Hospitals of Erlangen and Dresden, Germany. Testing consisted of three different scenarios where patients were asked to find specific information on the SKINFO website guided by the think-aloud method. Descriptive analysis and content analyses were performed. All patients would recommend SKINFO and appreciated its content, design, and structure. Think-aloud analysis identified the topics layout, navigation, and content and structure which would benefit from refinement. Major criticism included the navigation through the website, and the desire for more specific information addressing patients' relatives and the latest, up-to-date information. Overall, usability testing showed that the unique web-based information platform has the potential to support patients coping with skin cancer and thus strengthen informed decision-making.

Remote usability testing carried out during the COVID-19 pandemic on the example of Primo VE implementation in an Academic Library.

The article presents usability tests of Primo VE carried out as part of the implementation of the Alma library services platform at the Nicolaus Copernicus University Library. Remote usability tests were carried out during the COVID-19 pandemic. The aim of the tests was to assess the ease of use of selected system functionalities and the ease of learning how to use them by users. The method of remote usability testing using the Office365 application package, including MS Teams, was used. The tests allowed for the preparation of a report that took into account the identified problems and became the basis for introducing modifications to the configuration of the system's functionality and some elements of its interface, as well as for the preparation of instructional materials. The results indicate a fairly high level of intuitiveness of the interface and the analyzed functionalities. Test participants had no major problems with using Primo, apart from handling facets and full record services.

Development of a customizable interactions questionnaire (CIQ) for evaluating interactions with objects in augmented/virtual reality.

As new methods for interacting with systems are being developed for use within augmented or virtual reality, their impact on the quality of the user's experience needs to be assessed. Although many instruments exist for evaluating the overall user experience or the computer interface used to complete tasks, few provide measures that can be used to evaluate the specific forms of interaction typically used in these environments. This paper describes the development of a customizable questionnaire for measuring the subjective user experience that focuses on the quality of the interactions with objects in augmented reality/virtual reality (AR/VR) worlds, which we are calling the Customizable Interactions Questionnaire, or (CIQ). The final questionnaire measures five factors that are related to user satisfaction while using the system: quality of interactions, assessment of task performance, comfort, quality of sensory enhancements, and consistency with expectations.

The Optimal Sample Size for Usability Testing, From the Manufacturer's Perspective: A Value-of-Information Approach.

OBJECTIVES: For medical devices, a usability assessment is mandatory for market access; the objective is to detect potentially harmful use errors that stem from the device's design. The manufacturer assesses the final version of the device and determines the risk-benefit ratio for remaining errors. Nevertheless, the decision rule currently used to determine the sample size for this testing has statistical limitations and the lack of a clear decision-making perspective. METHODS: As an alternative, we developed a value-of-information analysis from the medical device manufacturer's perspective. The consequences of use errors not detected during usability testing and the errors' probability of occurrence were embedded in a loss function. The value of further testing was assessed as a reduction in the expected loss for the manufacturer. The optimal sample size was determined using the expected net benefit of sampling (ENBS) (the difference between the value provided by new participants and the cost of their inclusion). RESULTS: The value-of-information approach was applied to a real usability test of a needle-free adrenaline autoinjector. The initial estimate (performed on the first n = 20 participants) gave an optimal sample size of 100 participants and an ENBS of €255 453. This estimation was updated iteratively as new participants were included. After the inclusion of 90 participants, the ENBS was null for any sample size; hence, the cost of adding more participants outweighed the expected value of information, and therefore, the study could be stopped. CONCLUSIONS: On the basis of these results, our method seems to be highly suitable for sample size estimation in the usability testing of medical devices before market access.

Development and initial testing of a multi-stakeholder intervention for Lynch syndrome cascade screening: an intervention mapping approach.

BACKGROUND: Lynch syndrome is an underdiagnosed hereditary condition carrying an increased lifetime risk for colorectal and endometrial cancer and affecting nearly 1 million people in the United States. Cascade screening, systematic screening through family members of affected patients, could improve identification of Lynch syndrome, but this strategy is underused due to multi-level barriers including low knowledge about Lynch syndrome, low access to genetics services, and challenging family dynamics. METHODS: We used intervention mapping, a 6-step methodology to create stakeholder-driven interventions that meet the needs of a target population, to develop an intervention to improve cascade screening for Lynch syndrome. The intervention development process was guided by input from key stakeholders in Lynch syndrome care and patients. We conducted usability testing on the intervention with Lynch syndrome patients using qualitative semi-structured interviewing and rapid qualitative analysis. RESULTS: We developed a workbook intervention named Let's Talk that addresses gaps in knowledge, skills, self-efficacy, outcome expectancy and other perceived barriers to cascade screening for Lynch syndrome. Let's Talk contained educational content, goal setting activities, communication planning prompts and supplemental resources for patients to plan family communication. Evidence-based methods used in the workbook included information chunking, guided practice, goal setting and gain-framing. We conducted usability testing focused on the complexity and relative advantage of the intervention through 45-min virtual interviews with 10 adult patients with Lynch syndrome recruited from a national advocacy organization in the United States. Usability testing results suggested the intervention was acceptable in terms of complexity and relative advantage to other available resources, but additional information for communication with young or distant family members and a web-based platform could enhance the intervention's usability. CONCLUSIONS: Intervention mapping provided a framework for intervention development that addressed the unique needs of Lynch syndrome patients in overcoming barriers to cascade screening. Future work is needed to transform Let's Talk into a web-based tool and evaluate the effectiveness of the intervention in clinical practice with patients and genetic counselors. Intervention mapping can be useful to researchers as an evidence-based technique to develop stakeholder-centered interventions for addressing the needs of other unique populations.

User experience and acceptance of a device assisting persons with dementia in daily life: a multicenter field study.

BACKGROUND: Assistive technologies have the potential to facilitate everyday life of people with dementia and their families. Close collaboration with affected people and interdisciplinary research are essential to understand and address the needs of prospective users. In this study, we present the results of the evaluation of such an assistive system prototype. AIMS: Challenges from the patient and caregiver side, technical and design problems and acceptance and usability with regard to our special target group were evaluated. METHODS: MEMENTO, a system of two e-ink tablets and a smartwatch, was tested in the domestic environment of dementia patients. Thirty participants from Italy, Spain and Austria took part in a 3-month field trial and compared the MEMENTO system to traditional strategies in everyday life. Quantitative and qualitative data were collected and frequency of use of the system was monitored. RESULTS: There were no significant changes in quantitative measurements, such as activities of daily living and caregiver burden over the duration of the 3-month field trial. More frequent usage was significantly correlated with positive attitude towards technology (r = 0.723, p < 0.05), but not with age. The design of the system was positively emphasized, reducing fear of the technology on the one hand and stigmatization on the other. CONCLUSION: We show that a positive attitude towards technology is the essential variable for successful implementation of such systems, regardless of age. Participants showed great interest in digital solutions and agreed that technological systems will help in maintaining independency of persons with cognitive dysfunction in the future.

Improving usability of Electronic Health Records in a UK Mental Health setting: a feasibility study.

BACKGROUND: Electronic Health Records (EHRs) can help clinicians to plan, document and deliver care for patients in healthcare services. When used consistently, EHRs can advance patient safety and quality, and reduce clinician's workload. However, usability problems can make it difficult for clinicians to use EHRs effectively, which can negatively impact both healthcare professionals and patients. OBJECTIVE: To improve usability of EHRs within a mental health service in the UK. METHODS: This was a feasibility study conducted with two mental health teams. A mixed-methods approach was employed. Focus group discussions with clinicians identified existing usability problems in EHRs and changes were made to address these problems. Updated EHR assessment forms were evaluated by comparing the following measures pre and post changes: (1) usability testing to monitor time spent completing and duplicating patient information in EHRs, (2) clinician's experience of using EHRs, and (3) proportion of completed EHR assessment forms. RESULTS: Usability testing with clinicians (n = 3) showed that the time taken to complete EHR assessment forms and time spent duplicating patient information decreased. Clinician's experience of completing EHR assessment forms also significantly improved post changes compared to baseline (n = 71; p < 0.005). There was a significant increase in completion of most EHR forms by both teams after EHR usability improvements (all at p < 0.01). CONCLUSIONS: Usability improvements to EHRs can reduce the time taken to complete forms, advance clinician's experience and increase usage of EHRs. It is important to engage healthcare professionals in the usability improvement process of EHRs in mental health services.