%0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e63704 %T Patient Acceptability and Technical Reliability of Wearable Devices Used for Monitoring People With Parkinson Disease: Survey Study %A Rookes,Tasmin Alanna %A Batla,Amit %A Armstrong,Megan %A Ambler,Gareth %A Walters,Kate %A Schrag,Anette %K Parkinson disease %K feasibility %K remote monitoring %K Parkinson %K acceptability %K reliability %K wearable devices %K wearable %K self-management %K quantitative assessments %K quantitative %K qualitative %K monitoring %K patient %D 2025 %7 25.3.2025 %9 %J JMIR Form Res %G English %X Background: Parkinson disease is a progressive neurodegenerative disorder with complex motor and nonmotor symptoms. To assess these, clinical assessments are completed, providing a snapshot of a person’s experience. Monitoring Parkinson disease using wearable devices can provide continuous and objective data and capture information on movement patterns in daily life. Objective: The aim of the study is to assess patient acceptability and technical reliability of 2 wearable devices used in clinical trials (ActivInsights and Axivity AX3). Methods: Participants in a feasibility study testing a self-management toolkit (PD-Care) optionally wore a wearable device for 1 week, providing feedback through an open- and closed-question survey conducted over the telephone about the acceptability of wearing the device. The closed questions used a Likert scale from 1 to 5 (with 1=strongly agree and 5=strongly disagree) asking whether (1) the device was comfortable to wear, (2) the device was easy to put on, (3) the device was easy to wear, (4) the device was embarrassing to wear, and (5) if they were happy to wear the device for longer than 7 days. Differences in acceptability between devices were analyzed using Mann-Whitney U tests and Wilcoxon matched pairs signed rank tests. These were followed by open-ended questions asking (1) How did you find wearing the device? (2) How did you find putting the device on? (3) Did you take it off and why? (4) What was your overall impression? (5) Did you prefer the wrist- or trunk-worn device and why (Axivity AX3 only)? Results: A total of 22 of 32 (69%) participants offered the device agreed to wear it. There were no significant differences in the demographic characteristics between those monitored and those who chose not to be. Acceptance with both devices was generally good. The ActivInsights device was more acceptable than the wrist- and trunk-worn Axivity AX3 devices, as more participants found it to be comfortable (n=15, 100% vs n=5, 71%; P=.02 and n=4, 57%; P=.004, respectively), easy to wear (n=15, 100% vs n=6, 86%; P=.048 and n=3, 43%; P=.004, respectively) and would wear for more than 7 days (n=13, 87% vs n=4, 57%; P=.02 and n=1, 14%; P<.001, respectively). The trunk-worn Axivity AX3 device had the lowest acceptance rates, but there were no statistical differences in acceptability between the wrist- and trunk-worn Axivity AX3 devices (all P>.05). There were issues with battery life and recording errors in 3 of 14 (21%) Axivity AX3 devices and upload failures in 3 of 15 (20%) ActivInsights devices. Conclusions: Acceptability of wearables for monitoring Parkinson was satisfactory, especially when wrist-worn, although a few participants experienced difficulties in correct use, and there were some errors with the data upload. Trial Registration: ISRCTN Registry ISRCTN92831552; https://www.isrctn.com/ISRCTN92831552 %R 10.2196/63704 %U https://formative.jmir.org/2025/1/e63704 %U https://doi.org/10.2196/63704 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e54560 %T User Experience of a Bespoke Videoconferencing System for Web-Based Family Visitation for Patients in an Intensive Care Unit: 1-Year Cross-Sectional Survey of Nursing Staff %A Murray,Aoife %A Conroy,Irial %A Kirrane,Frank %A Cullen,Leonie %A Worlikar,Hemendra %A O'Keeffe,Derek T %K telemedicine %K health %K telehealth %K videoconferencing %K web-based %K usability %K intensive care %K critical care %K communication %K COVID-19 %K SARS-COV-2 %K intensive care unit %K ICU %K cross-sectional survey %K nursing %K transmission %K transmission risk %K usability questionnaire %K questionnaire %K reliability %K satisfaction %K usefulness %K family %D 2025 %7 21.3.2025 %9 %J JMIR Hum Factors %G English %X Background: During the COVID-19 pandemic, in-person visitation within hospitals was restricted and sometimes eliminated to reduce the risk of transmission of SARS-CoV-2. Many health care professionals created novel strategies that were deployed to maintain a patient-centered approach. Although pandemic-related restrictions have eased, these systems, including videoconferencing or web-based bedside visits, remain relevant for visitors who cannot be present due to other reasons (lack of access to transport, socioeconomic restraints, geographical distance, etc). Objective: The aims of this study were (1) to report the experience of intensive care nursing staff using a bespoke videoconferencing system called ICU FamilyLink; (2) to examine the scenarios in which the nursing staff used the system; and (3) to assess the future use of videoconferencing systems to enhance communication with families. Methods: A modified Telehealth Usability questionnaire was administered to the nursing staff (N=22) of an intensive care unit in a model 4 tertiary hospital in Ireland 1 year after implementing the bespoke videoconferencing system. Results: In total, 22 nurses working in the intensive care department at University Hospital Galway, Ireland, responded to the survey. A total of 23% (n=5) of participants were between the ages of 25 and 34 years, 54% (n=12) were between 35 and 44 years, and 23% (n=5) were between 45 and 54 years. Most (n=15, 68%) of the participants reported never using videoconferencing in the intensive care setting to communicate with family members before March 2020. The modified Telehealth Usability Questionnaire showed overall satisfaction scores for each subcategory of ease of use and learnability, interface quality, interaction quality, reliability, satisfaction and future use, and usefulness. In total, 21 (95%) participants agreed or strongly agreed with the statement, “I would use the ICU FamilyLink system in future circumstances in which family members cannot be physically present (ie, pandemics, abroad, inability to travel, etc),” and 1 participant responded neutrally. One participant highlighted a common scenario in intensive care settings in which a videoconferencing system can be used “Even without COVID, web-based communication is important when patients become unexpectedly ill and when families are abroad.” Conclusions: This study provides valuable insights into health care professionals’ experience using a videoconferencing system to facilitate web-based visits for families. We conclude that videoconferencing systems when appropriately tailored to the environment with the users in mind can be an acceptable solution to maintain communication with family members who cannot be physically present at the bedside. The bespoke videoconferencing system had an overall positive response from 22 nursing staff who interacted with the system at varying frequency levels. %R 10.2196/54560 %U https://humanfactors.jmir.org/2025/1/e54560 %U https://doi.org/10.2196/54560 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e64664 %T Use of Wearable Transdermal Alcohol Sensors for Monitoring Alcohol Consumption After Detoxification With Contingency Management: Pilot Randomized Feasibility Trial %A Brobbin,Eileen %A Drummond,Colin %A Parkin,Stephen %A Deluca,Paolo %+ King's College London, 4 Windswor Walk, Denmark Hill, London, SE5 8BB, United Kingdom, 44 07758287265, eileen.brobbin@kcl.ac.uk %K alcohol %K alcohol dependence %K alcohol monitoring %K alcohol treatment %K contingency management %K transdermal alcohol sensor %K transdermal technology %K wearable %K wearable alcohol biosensor %D 2025 %7 14.3.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Wearable transdermal alcohol sensor (TAS) devices generate continuous data on alcohol consumption through the indiscernible sweat vapors on the skin. This continuous alcohol monitoring capability could provide a new method for alcohol services to monitor service users at various stages of their alcohol treatment. Objective: We aimed to assess the feasibility of using a TAS as part of alcohol treatment with alcohol service users using the device with or without contingency management (CM). Methods: A feasibility study was conducted of a convenience sample of 29 current service users from 3 South London alcohol services. Participants were randomized into either a control (treatment as usual) or CM group (treatment as usual+CM). We assessed the feasibility of enrollment, participation, device tampering and return, and device wearability and the accuracy of data capture. These data were reported descriptively where appropriate, the groups were compared, and alcohol self-report data were compared to the transdermal alcohol concentration to assess accuracy. Results: A total of 34 individuals were approached, and 32 (94%) were enrolled and randomized (n=17, 53% to the control group and n=15, 47% to the CM group) over 5 months. In total, 3 participants withdrew (n=2, 67% from the control group and n=1, 33% from the CM group). There was a total of 203 meetings arranged (29 participants × 7 meetings), and 185 (91.1%) were attended. Only 1 of the 29 participants (3%) admitted to turning the TAS off to avoid monitoring. There were some issues with the TAS not functioning properly and not being able to be cleaned. Removals were recorded, but the definition of TAS removal may need to be improved for future trials. There was a high TAS return rate (28/29, 97% of the participants returned the TAS). Secondary outcomes suggest that the BACtrack Skyn remains an accurate tool to monitor alcohol consumption compared to self-report data and that it is acceptable to wearers over 2 weeks, with many participants (27/28, 96%) answering that they would wear it again and for longer but that the CM procedure could be made clearer. Conclusions: The delivery of CM via a TAS was feasible in this study, but recommendations for a future larger trial include that the study design should be changed to provide an operationalized rather than manual method of checking whether TAS data meet CM criteria. This would reduce researcher burden and researcher and participant time. Current recruitment and research meeting design seem suitable for a future larger trial. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN46845361; https://www.isrctn.com/ISRCTN46845361 %M 40085839 %R 10.2196/64664 %U https://humanfactors.jmir.org/2025/1/e64664 %U https://doi.org/10.2196/64664 %U http://www.ncbi.nlm.nih.gov/pubmed/40085839 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e66634 %T Identifying Strategies for Home Management of Ostomy Care: Content Analysis of YouTube %A Haughey,Marketa %A Neyens,David M %A Hopkins,Casey S %A Gonzaga,Christofer %A Harman,Melinda %+ Department of Bioengineering, Clemson University, 301 Rhodes Engineering Research Center, Clemson, SC, 29634, United States, 1 8646564140, harman2@clemson.edu %K medical device usability %K digital health %K online support groups %K living with chronic medical conditions %K ostomy self-care %K YouTube %K patient education %K user needs assessment %K users experience %K social media %K ostomates %K colostomy %K ileostomy %K usability %K usefulness %K utility %K wearable device %K medical device %K support group %K socials %K social network %K ostomy %K digital %K digital technology %K digital intervention %D 2025 %7 6.3.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: The social media platform YouTube is a recognized educational resource for health information, but few studies have explored its value for conveying the lived experience of individuals managing chronic health conditions and end users’ interactions with medical device technology. Our study explores self-care strategies and end user needs of people living with a stoma because patient education and engagement in ostomy self-care are essential for avoiding ostomy-related complications. Ostomy surgery creates a stoma (an opening) in the abdomen to alter the route of excreta from digestive and urinary organs into a detachable external pouching system. After hospital discharge, people who have undergone ostomies perform critical self-care tasks including frequent ostomy appliance changes and stomal and peristomal skin maintenance. Objective: The purpose of this study was to systematically assess YouTube videos narrated by people who have undergone ostomies about their ostomy self-care in home (nonhospital) settings with a focus on identifying end user needs and different strategies used by people who have undergone ostomies during critical self-care tasks. Methods: Using predefined search terms and clear inclusion and exclusion criteria, we identified YouTube videos depicting narrators who have undergone ostomies and their ostomy self-care in home settings. Using a consensus coding approach among 3 independent reviewers, all videos were analyzed to collect metadata, data of narrators who have undergone ostomies, and specific content data. Results: There were 65 user-generated YouTube videos that met the inclusion and exclusion criteria. These videos were posted by 28 unique content creators representing a broad range of ages who used a variety of supplies. The common challenges discussed were peristomal skin complications, inadequate appliance adhesion and subsequent leakage, and supplies-related challenges. Narrators who have undergone ostomies discussed various expert tricks and tips to successfully combat these challenges. Conclusions: This study used a novel approach to gain insights about end user interactions with medical devices while performing ostomy self-care, which are difficult to gain using traditional behavioral techniques. The analysis revealed that people who have undergone ostomies are willing to share their personal experience with ostomy self-care on the web and that these videos are viewed by the public. User-generated videos demonstrated a variety of supplies used, end user needs, and different strategies for performing ostomy self-care. Future research should examine how these findings connect to YouTube ostomy self-care content generated by health care professionals and organizations and to guidelines for ostomy self-care. %M 40053741 %R 10.2196/66634 %U https://humanfactors.jmir.org/2025/1/e66634 %U https://doi.org/10.2196/66634 %U http://www.ncbi.nlm.nih.gov/pubmed/40053741 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e59780 %T The mChoice App, an mHealth Tool for the Monitoring of Preexposure Prophylaxis Adherence and Sexual Behaviors in Young Men Who Have Sex With Men: Usability Evaluation %A Dos Santos,Fabiana Cristina %A Brin,Maeve %A Tanner,Mary R %A Galindo,Carla A %A Schnall,Rebecca %K HIV prevention %K data visualization %K patient-reported health information %K mHealth %K digital health %K usability %K human immunodeficiency virus %K preexposure prophylaxis %K men who have sex with men %K apps %K HIV %K PrEP %D 2025 %7 28.2.2025 %9 %J JMIR Hum Factors %G English %X Background: Mobile health (mHealth) apps provide easy and quick access for end users to monitor their health-related activities. Features such as medication reminders help end users adhere to their medication schedules and automatically record these actions, thereby helping manage their overall health. Due to insufficient mHealth tools tailored for HIV preventive care in young men who have sex with men (MSM), our study evaluated the usability of the mChoice app, a tool designed to enhance preexposure prophylaxis (PrEP) adherence and promote sexual health (eg, encouraging the use of condoms and being aware of the partner’s HIV status and PrEP use). Objective: This study aimed to apply systematic usability evaluations to test the mChoice app and to refine the visualizations to better capture and display patient-reported health information. Methods: Usability testing involved heuristic evaluations conducted with 5 experts in informatics and user testing with 20 young MSM who were taking or were eligible to take PrEP. Results: End users demonstrated satisfaction with the appearance of the mChoice app, reporting that the app has an intuitive interface to track PrEP adherence. However, participants highlighted areas needing improvement, including chart titles and the inclusion of “undo” and “edit” buttons to improve user control when recording PrEP use. Conclusions: Usability evaluations involving heuristic experts and end users provided valuable insights into the mChoice app’s design. Areas for improvement were identified, such as enhancing chart readability and providing additional user controls. These findings will guide iterative refinements, ensuring that future versions of the app better address the needs of its target audience and effectively support HIV prevention. %R 10.2196/59780 %U https://humanfactors.jmir.org/2025/1/e59780 %U https://doi.org/10.2196/59780 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e60273 %T The Effects of Presenting AI Uncertainty Information on Pharmacists’ Trust in Automated Pill Recognition Technology: Exploratory Mixed Subjects Study %A Kim,Jin Yong %A Marshall,Vincent D %A Rowell,Brigid %A Chen,Qiyuan %A Zheng,Yifan %A Lee,John D %A Kontar,Raed Al %A Lester,Corey %A Yang,Xi Jessie %+ , Industrial and Operations Engineering, University of Michigan, 1640 IOE, 1205 Beal Avenue, Ann Arbor, MI, 48105, United States, 1 7347630541, xijyang@umich.edu %K artificial intelligence %K human-computer interaction %K uncertainty communication %K visualization %K medication errors %K safety %K artificial intelligence aid %K pharmacists %K pill verification %K automation %D 2025 %7 11.2.2025 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Dispensing errors significantly contribute to adverse drug events, resulting in substantial health care costs and patient harm. Automated pill verification technologies have been developed to aid pharmacists with medication dispensing. However, pharmacists’ trust in such automated technologies remains unexplored. Objective: This study aims to investigate pharmacists’ trust in automated pill verification technology designed to support medication dispensing. Methods: Thirty licensed pharmacists in the United States performed a web-based simulated pill verification task to determine whether an image of a filled medication bottle matched a known reference image. Participants completed a block of 100 verification trials without any help, and another block of 100 trials with the help of an imperfect artificial intelligence (AI) aid recommending acceptance or rejection of a filled medication bottle. The experiment used a mixed subjects design. The between-subjects factor was the AI aid type, with or without an AI uncertainty plot. The within-subjects factor was the four potential verification outcomes: (1) the AI rejects the incorrect drug, (2) the AI rejects the correct drug, (3) the AI approves the incorrect drug, and (4) the AI approves the correct drug. Participants’ trust in the AI system was measured. Mixed model (generalized linear models) tests were conducted with 2-tailed t tests to compare the means between the 2 AI aid types for each verification outcome. Results: Participants had an average trust propensity score of 72 (SD 18.08) out of 100, indicating a positive attitude toward trusting automated technologies. The introduction of an uncertainty plot to the AI aid significantly enhanced pharmacists’ end trust (t28=–1.854; P=.04). Trust dynamics were influenced by AI aid type and verification outcome. Specifically, pharmacists using the AI aid with the uncertainty plot had a significantly larger trust increment when the AI approved the correct drug (t78.98=3.93; P<.001) and a significantly larger trust decrement when the AI approved the incorrect drug (t2939.72=–4.78; P<.001). Intriguingly, the absence of the uncertainty plot led to an increase in trust when the AI correctly rejected an incorrect drug, whereas the presence of the plot resulted in a decrease in trust under the same circumstances (t509.77=–3.96; P<.001). A pronounced “negativity bias” was observed, where the degree of trust reduction when the AI made an error exceeded the trust gain when the AI made a correct decision (z=–11.30; P<.001). Conclusions: To the best of our knowledge, this study is the first attempt to examine pharmacists’ trust in automated pill verification technology. Our findings reveal that pharmacists have a favorable disposition toward trusting automation. Moreover, providing uncertainty information about the AI’s recommendation significantly boosts pharmacists’ trust in AI aid, highlighting the importance of developing transparent AI systems within health care. %M 39932773 %R 10.2196/60273 %U https://humanfactors.jmir.org/2025/1/e60273 %U https://doi.org/10.2196/60273 %U http://www.ncbi.nlm.nih.gov/pubmed/39932773 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 9 %N %P e58219 %T Technology Readiness Level and Self-Reported Health in Recipients of an Implantable Cardioverter Defibrillator: Cross-Sectional Study %A Rosenmeier,Natasha %A Busk,David %A Dichman,Camilla %A Nielsen,Kim Mechta %A Kayser,Lars %A Wagner,Mette Kirstine %+ Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Copenhagen, 1353, Denmark, 45 35334448, sncb91@gmail.com %K implantable cardioverter defibrillator %K health literacy %K self-management %K ICD rehabilitation %K digital health literacy %K patient-reported outcome measure %K self-reported %K self-rated %K exploratory %K interview %K sociodemographic %K survey %K cluster analysis %K mixed method %K cross-sectional %K Denmark %D 2025 %7 6.2.2025 %9 Original Paper %J JMIR Cardio %G English %X Background: Approximately 200,000 implantable cardioverter defibrillators (ICDs) are implanted annually worldwide, with around 20% of recipients experiencing significant psychological distress. Despite this, there are no ICD guidelines addressing mental health as part of rehabilitation programs, which primarily focus on educating patients about their condition and prognosis. There is a need to include elements such as emotional distress, social interactions, and the future use of technologies like apps and virtual communication in ICD rehabilitation, without increasing the burden on health care professionals. Objective: This study aimed to demonstrate how data from the Readiness for Health Technology Index (READHY), combined with sociodemographic characteristics and exploratory interviews, can be used to construct profiles of recipients of an ICD, describing their ability to manage their condition, their need for support, and their digital health literacy. This aims to enhance health care professionals’ understanding of different patient archetypes, serving as guidance in delivering personalized services tailored to the needs, resources, and capabilities of individual recipients of ICDs. Methods: Overall, 79 recipients of an ICD participated in a survey assessing technology readiness using the READHY. The survey also collected sociodemographic data such as age, sex, and educational level. Self-reported health was measured using a Likert scale. Cluster analysis categorized participants into profiles based on their READHY scores. Correlations between READHY scores and self-reported health were examined. In addition, qualitative interviews with representatives from different readiness profiles provided deeper insights. Results: Four technology readiness profiles were found: (1) profile 1 (low digital health literacy, insufficient on 5 dimensions), (2) profile 2 (sufficient on all dimensions), (3) profile 3 (consistently sufficient readiness on all dimensions), and (4) profile 4 (insufficient readiness on 9 dimensions). Participants in profile 4, characterized by the lowest readiness levels, were significantly younger (P=.03) and had lower self-reported health (P<.001) than those in profile 3. A correlation analysis revealed that higher READHY scores were associated with better self-reported health across all dimensions. Qualitative interviews highlighted differences in self-management approaches and the experience of support between profiles, emphasizing the essential role of social support toward the rehabilitation journeys of recipients of an ICD. Two patient vignettes were created based on the characteristics from the highest and lowest profiles. Conclusions: Using the READHY instrument to create patient profiles demonstrates how it can be used to make health care professionals aware of specific needs within the group of recipients of an ICD. %M 39913910 %R 10.2196/58219 %U https://cardio.jmir.org/2025/1/e58219 %U https://doi.org/10.2196/58219 %U http://www.ncbi.nlm.nih.gov/pubmed/39913910 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e67036 %T Device Failures and Adverse Events Associated With Rhinolaryngoscopes: Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database %A Chang,Shao-Hsuan %A Chen,Daishi %A Chen,Chi-Sheng %A Zhou,Dong %A Yeh,Lung-Kun %K medical device %K device malfunction %K rhinolaryngoscope %K adverse event %K MAUDE %K Manufacturer and User Facility Device Experience %D 2025 %7 5.2.2025 %9 %J JMIR Hum Factors %G English %X Background: Rhinolaryngoscopes are one of the most widely used tools by otolaryngologists and speech-language pathologists in current clinical practice. However, there is limited data on adverse events associated with or caused by the use of rhinolaryngoscopes. Objective: In this study, we used the Manufacturer and User Facility Device Experience (MAUDE) database with the aim of providing insights that may assist otolaryngologists in better understanding the limitations of these devices and selecting appropriate procedures for their specific clinical setting. Methods: We characterized complications associated with the postmarket use of rhinolaryngoscope devices from the US Food and Drug Administration MAUDE database from 2016 through 2023. Results: A total of 2591 reports were identified, including 2534 device malfunctions, 56 injuries, and 1 death, from 2016 through 2023. The most common device problem with rhinolaryngoscopes was breakage (n=1058 reports, 40.8%), followed by fluid leaks (n=632 reports, 24.4%). The third most common problem was poor image quality (n=467 reports, 18%). Other device issues included contamination or device reprocessing problems (n=127 reports, 4.9%), material deformation or wear (n=125 reports, 4.8%), and device detachment (n=73 reports, 2.8%). Of the 63 reported adverse events, the most common patient-related adverse event was hemorrhage or bleeding, accounting for 18 reports, with the root causes including material deformation or wear, breakage, wrinkled rubber, or improper operation. Conclusions: Our study offers valuable insights for endoscopists and manufacturers to recognize potential issues and adverse events associated with the use of rhinolaryngoscopes. It emphasizes the need for improving device reliability, training, and procedural protocols to enhance patient safety during diagnostic procedures. %R 10.2196/67036 %U https://humanfactors.jmir.org/2025/1/e67036 %U https://doi.org/10.2196/67036 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 14 %N %P e66694 %T The Evolution of Uroflowmetry and Bladder Diary and the Emerging Trend of Using Home Devices From Hospital to Home %A Li,Ming-wei %A Tsai,Yao-Chou %A Yang,Stephen Shei-Dei %A Pong,Yuan-Hung %A Tsai,Yu-Ting %A Tsai,Vincent Fang-Sheng %+ Division of Urology, Department of Surgery, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, 16F, No 289, Jianguo Road, New Taipei City, 231016, Taiwan, 886 952 691807, ntubala@gmail.com %K lower urinary tract symptoms %K uroflowmetry %K bladder diary %K home devices %K bladder %K noninvasive %K evaluations %K viewpoint %K diagnostic %K mobile health %D 2025 %7 28.1.2025 %9 Viewpoint %J Interact J Med Res %G English %X Although uroflowmetry and bladder diaries are widely used for noninvasive evaluation of lower urinary tract symptoms, they still have limitations in diagnostic capability and users’ convenience. The aim of this paper is to discuss potential solutions by reviewing (1) the evolution and current clinical use of uroflowmetry and bladder diary, including clinical guidelines, daily practice applications, and their historical development; (2) a growing trend toward using home devices with various technologies; and (3) a comprehensive comparison of the strengths and weaknesses of these home devices. In our opinion, the following points can be highlighted: (1) the emerging trend of using home devices can enhance diagnostic capabilities through repeated measurements and the convenience of at-home testing and (2) home devices, which provide both frequency-volume and uroflowmetry information, have the potential to transform the management of lower urinary tract symptoms. %M 39874564 %R 10.2196/66694 %U https://www.i-jmr.org/2025/1/e66694 %U https://doi.org/10.2196/66694 %U http://www.ncbi.nlm.nih.gov/pubmed/39874564 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e56039 %T Satisfactory Evaluation of Call Service Using AI After Ureteral Stent Insertion: Randomized Controlled Trial %A Cho,Ukrae %A Gwon,Yong Nam %A Chong,Seung Ryong %A Han,Ji Yeon %A Kim,Do Kyung %A Doo,Seung Whan %A Yang,Won Jae %A Kim,Kyeongmin %A Shim,Sung Ryul %A Jung,Jaehun %A Kim,Jae Heon %+ Department of Urology, Soonchunhyang University Seoul Hospital, Soonchunhyang University Medical College, 59 Daesagwan-ro, Yongsan-gu, Seoul, 04401, Republic of Korea, 82 2 709 9378, piacekjh@hanmail.net %K artificial intelligence %K AI %K ureteral stent %K complications %K randomized controlled trial %K urologic procedures %K urology %K patients %K information resources %D 2025 %7 21.1.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Ureteral stents, such as double-J stents, have become indispensable in urologic procedures but are associated with complications like hematuria and pain. While the advancement of artificial intelligence (AI) technology has led to its increasing application in the health sector, AI has not been used to provide information on potential complications and to facilitate subsequent measures in the event of such complications. Objective: This study aimed to assess the effectiveness of an AI-based prediction tool in providing patients with information about potential complications from ureteroscopy and ureteric stent placement and indicating the need for early additional therapy. Methods: Overall, 28 patients (aged 20-70 years) who underwent ureteral stent insertion for the first time without a history of psychological illness were consecutively included. A “reassurance-call” service was set up to equip patients with details about the procedure and postprocedure care, to monitor for complications and their severity. Patients were randomly allocated into 2 groups, reassurance-call by AI (group 1) and reassurance-call by humans (group 2). The primary outcome was the level of satisfaction with the reassurance-call service itself, measured using a Likert scale. Secondary outcomes included satisfaction with the AI-assisted reassurance-call service, also measured using a Likert scale, and the level of satisfaction (Likert scale and Visual Analogue Scale [VAS]) and anxiety (State-Trait Anxiety Inventory and VAS) related to managing complications for both groups. Results: Of the 28 recruited patients (14 in each group), 1 patient in group 2 dropped out. Baseline characteristics of patients showed no significant differences (all P>.05). Satisfaction with reassurance-call averaged 4.14 (SD 0.66; group 1) and 4.54 (SD 0.52; group 2), with no significant difference between AI and humans (P=.11). AI-assisted reassurance-call satisfaction averaged 3.43 (SD 0.94). Satisfaction about the management of complications using the Likert scale averaged 3.79 (SD 0.70) and 4.23 (SD 0.83), respectively, showing no significant difference (P=.14), but a significant difference was observed when using the VAS (P=.01), with 6.64 (SD 2.13) in group 1 and 8.69 (SD 1.80) in group 2. Anxiety about complications using the State-Trait Anxiety Inventory averaged 36.43 (SD 9.17) and 39.23 (SD 8.51; P=.33), while anxiety assessed with VAS averaged 4.86 (SD 2.28) and 3.46 (SD 3.38; P=.18), respectively, showing no significant differences. Multiple regression analysis was performed on all outcomes, and humans showed superior satisfaction than AI in the management of complications. Otherwise, most of the other variables showed no significant differences (P.>05). Conclusions: This is the first study to use AI for patient reassurance regarding complications after ureteric stent placement. The study found that patients were similarly satisfied for reassurance calls conducted by AI or humans. Further research in larger populations is warranted to confirm these findings. Trial Registration: Clinical Research Information System KCT0008062; https://tinyurl.com/4s8725w2 %M 39836955 %R 10.2196/56039 %U https://www.jmir.org/2025/1/e56039 %U https://doi.org/10.2196/56039 %U http://www.ncbi.nlm.nih.gov/pubmed/39836955 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e65142 %T Evaluating the Safety and Usability of an Over-the-Counter Medical Device for Adults With Mild to Moderate Hearing Loss: Formative and Summative Usability Testing %A Salwei,Megan Elizabeth %A Anders,Shilo %A Reale,Carrie %A Slagle,Jason M %A Ricketts,Todd %A Weinger,Matthew B %K usability %K human factors %K patient safety %K over-the-counter hearing aids %K direct-to-consumer hearing aids %K medical device %K hearing loss %K adult %K hearing impairment %K hearing aid use %K hearing care %K formative usability test %K safety %K mobile phone %D 2025 %7 20.1.2025 %9 %J JMIR Hum Factors %G English %X Background: Only 15% of the nearly 30 million Americans with hearing loss use hearing aids, partly due to high cost, stigma, and limited access to professional hearing care. Hearing impairment in adults can lead to social isolation and depression and is associated with an increased risk of falls. Given the persistent barriers to hearing aid use, the Food and Drug Administration issued a final rule to allow over-the-counter hearing aids to be sold directly to adult consumers with perceived mild to moderate hearing loss at pharmacies, stores, and online retailers without seeing a physician or licensed hearing health care professional. Objective: We evaluated the safety and usability of an over-the-counter hearing aid prior to Food and Drug Administration approval and market release. Methods: We first conducted a formative usability test of the device and associated app with 5 intended users to identify outstanding safety and usability issues (testing round 1). Following design modifications, we performed a summative usability test with 15 intended users of the device (testing round 2). We concurrently conducted a test with 21 nonintended users (ie, users with contraindications to use) to ascertain if consumers could determine when they should not use the device, based on the packaging, instructions, and labeling (testing round 3). Participants were asked to complete 2‐5 tasks, as if they were using the hearing aid in real life. After each task, participants rated the task difficulty. At the end of each session, participants completed a 10-question knowledge assessment and the System Usability Scale and then participated in debriefing interviews to gather qualitative feedback. All sessions were video recorded and analyzed to identify use errors and design improvement opportunities. Results: Usability issues were identified in all 3 usability testing rounds. There were minimal safety-related issues with the device. Round 1 testing led to several design modifications which then increased task success in round 2 testing. Participants had the most difficulty with the task of pairing the hearing aids to the cell phone. Participants also had difficulty distinguishing the right and left earbuds. Nonintended users did not always understand device contraindications (eg, tinnitus and severe hearing loss). Overall, test findings informed 9 actionable design modifications (eg, clarifying pairing steps and increasing font size) that improved device usability and safety. Conclusions: This study evaluated the usability and safety of an over-the-counter hearing aid for adults with mild to moderate hearing loss. Human factors engineering methods identified opportunities to improve the safety and usability of this direct-to-consumer medical device for individuals with perceived mild-moderate hearing loss. %R 10.2196/65142 %U https://humanfactors.jmir.org/2025/1/e65142 %U https://doi.org/10.2196/65142 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 12 %N %P e63641 %T User Acceptance of a Home Robotic Assistant for Individuals With Physical Disabilities: Explorative Qualitative Study %A Sørensen,Linda %A Sagen Johannesen,Dag Tomas %A Melkas,Helinä %A Johnsen,Hege Mari %+ Department of Health and Nursing Science, Faculty of Health and Sport Sciences, University of Agder, Postbox 422, Kristiansand, 4604, Norway, 47 99473420, linda.sorensen@uia.no %K physical artificial intelligence %K physical AI %K health care robotics %K assistive technology %K content analysis %K qualitative %K health care %K robotics %K assistive %K robot interaction %K physical disabilities %K readiness %K amputations %D 2025 %7 13.1.2025 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Health care is shifting toward 5 proactive approaches: personalized, participatory, preventive, predictive, and precision-focused services (P5 medicine). This patient-centered care leverages technologies such as artificial intelligence (AI)–powered robots, which can personalize and enhance services for users with disabilities. These advancements are crucial given the World Health Organization’s projection of a global shortage of up to 10 million health care workers by 2030. Objective: This study aimed to investigate the acceptance of a humanoid assistive robot among users with physical disabilities during (1) AI-powered (using a Wizard of Oz methodology) robotic performance of predefined personalized assistance tasks and (2) operator-controlled robotic performance (simulated distant service). Methods: An explorative qualitative design was used, involving user testing in a simulated home environment and individual interviews. Directed content analysis was based on the Almere model and the model of domestic social robot acceptance. Results: Nine participants with physical disabilities aged 27 to 78 years engaged in robot interactions. They shared their perceptions across 7 acceptance concepts: hedonic attitudes, utilitarian attitudes, personal norms, social norms, control beliefs, facilitating conditions, and intention to use. Participants valued the robot’s usefulness for practical services but not for personal care. They preferred automation but accepted remote control of the robot for some tasks. Privacy concerns were mixed. Conclusions: This study highlights the complex interplay of functional expectations, technological readiness, and personal and societal norms affecting the acceptance of physically assistive robots. Participants were generally positive about robotic assistance as it increases independence and lessens the need for human caregivers, although they acknowledged some current shortcomings. They were open to trying more home testing if future robots could perform most tasks autonomously. AI-powered robots offer new possibilities for creating more adaptable and personalized assistive technologies, potentially enhancing their effectiveness and viability for individuals with disabilities. %M 39805579 %R 10.2196/63641 %U https://rehab.jmir.org/2025/1/e63641 %U https://doi.org/10.2196/63641 %U http://www.ncbi.nlm.nih.gov/pubmed/39805579 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e62740 %T Measuring Bound Attention During Complex Liver Surgery Planning: Feasibility Study %A Schneider,Tim %A Cetin,Timur %A Uppenkamp,Stefan %A Weyhe,Dirk %A Muender,Thomas %A Reinschluessel,Anke V %A Salzmann,Daniela %A Uslar,Verena %+ University Hospital for Visceral Surgery, PIUS-Hospital, Department for Human Medicine, Faculty VI, University of Oldenburg, Ammerländer Heerstraße 114-118, Oldenburg, 26129, Germany, 49 4412292922, tim.schneider@uol.de %K workload measurement %K virtual reality %K VR %K augmented reality %K AR %K electroencephalography %K EEG %K event-related potential %K ERP %K auditory evoked potential %K AEP %K oddball experiment %K National Aeronautics and Space Administration Task Load Index %K NASA-TLX %K surgical planning %D 2025 %7 8.1.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: The integration of advanced technologies such as augmented reality (AR) and virtual reality (VR) into surgical procedures has garnered significant attention. However, the introduction of these innovations requires thorough evaluation in the context of human-machine interaction. Despite their potential benefits, new technologies can complicate surgical tasks and increase the cognitive load on surgeons, potentially offsetting their intended advantages. It is crucial to evaluate these technologies not only for their functional improvements but also for their impact on the surgeon’s workload in clinical settings. A surgical team today must increasingly navigate advanced technologies such as AR and VR, aiming to reduce surgical trauma and enhance patient safety. However, each innovation needs to be evaluated in terms of human-machine interaction. Even if an innovation appears to bring advancements to the field it is applied in, it may complicate the work and increase the surgeon’s workload rather than benefiting the surgeon. Objective: This study aims to establish a method for objectively determining the additional workload generated using AR or VR glasses in a clinical context for the first time. Methods: Electroencephalography (EEG) signals were recorded using a passive auditory oddball paradigm while 9 participants performed surgical planning for liver resection across 3 different conditions: (1) using AR glasses, (2) VR glasses, and (3) the conventional planning software on a computer. Results: The electrophysiological results, that is, the potentials evoked by the auditory stimulus, were compared with the subjectively perceived stress of the participants, as determined by the National Aeronautics and Space Administration-Task Load Index (NASA-TLX) questionnaire. The AR condition had the highest scores for mental demand (median 75, IQR 70-85), effort (median 55, IQR 30-65), and frustration (median 40, IQR 15-75) compared with the VR and PC conditions. The analysis of the EEG revealed a trend toward a lower amplitude of the N1 component as well as for the P3 component at the central electrodes in the AR condition, suggesting a higher workload for participants when using AR glasses. In addition, EEG components in the VR condition did not reveal any noticeable differences compared with the EEG components in the conventional planning condition. For the P1 component, the VR condition elicited significantly earlier latencies at the Fz electrode (mean 75.3 ms, SD 25.8 ms) compared with the PC condition (mean 99.4 ms, SD 28.6 ms). Conclusions: The results suggest a lower stress level when using VR glasses compared with AR glasses, likely due to the 3D visualization of the liver model. Additionally, the alignment between subjectively determined results and objectively determined results confirms the validity of the study design applied in this research. %M 39773449 %R 10.2196/62740 %U https://formative.jmir.org/2025/1/e62740 %U https://doi.org/10.2196/62740 %U http://www.ncbi.nlm.nih.gov/pubmed/39773449 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e55032 %T Collecting Feedback From Neurologists and Patients to Guide Development of a Parkinson Disease App (DigiPark): Qualitative, Noninterventional Study %A Duracinsky,Martin %A Brown Hajdukova,Eva %A Péretz,Fabienne %A Sauzin,Julie %A Gouider-Khouja,Neziha %A Atlani,Caroline %A Dalili,Djamchid %K DigiPark %K Parkinson disease %K patient-centered app %K smartphones %K usability testing %K mHealth %K mobile health %D 2024 %7 31.12.2024 %9 %J JMIR Hum Factors %G English %X Background: Parkinson disease (PD) is a worldwide, fast-growing, progressive neurodegenerative condition. Its multifaceted clinical presentation includes a wide range of motor and nonmotor symptoms. Smartphones present a potential solution to better monitor and subsequently alleviate PD symptoms. Objective: The aim of this study is to explore neurologists’ and patients’ needs and preferences regarding the design and functionality of a new smartphone app for PD, DigiPark. Methods: This qualitative, noninterventional study gathered data through two primary methods: (1) by conducting interviews with 9 neurologists and (2) through a usability test including 5 patients with PD. Results: The neurologists affirmed the necessity for a patient-centered app, highlighting the complexities of PD management. They advocated for personalized app functionalities to improve patients’ quality of life and emphasized the need for enhanced patient-provider communication. Feedback from the usability test indicated a preference for a clear, simple user interface, as well as elucidation of the app’s benefits. Concerns about the app’s time demands and the complexity of certain features like medication management were expressed. Furthermore, patients with PD consistently showed interest in features that could track and monitor their progress over time. This highlights the need to include clear benefits within the app to maintain user engagement and commitment. Conclusions: Neurologists’ and patients’ feedback on the design and functionality of the app complement each other. Collaborative efforts in shaping the app should better address genuine PD management needs. Future clinical trial inclusion can further validate the efficacy of DigiPark. %R 10.2196/55032 %U https://humanfactors.jmir.org/2024/1/e55032 %U https://doi.org/10.2196/55032 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e62959 %T Developing a Sleep Algorithm to Support a Digital Medicine System: Noninterventional, Observational Sleep Study %A Cochran,Jeffrey M %K actigraphy %K machine learning %K accelerometer %K sleep-wake cycles %K sleep monitoring %K sleep quality %K sleep disorder %K polysomnography %K wearable sensor %K electrocardiogram %D 2024 %7 20.12.2024 %9 %J JMIR Ment Health %G English %X Background: Sleep-wake patterns are important behavioral biomarkers for patients with serious mental illness (SMI), providing insight into their well-being. The gold standard for monitoring sleep is polysomnography (PSG), which requires a sleep lab facility; however, advances in wearable sensor technology allow for real-world sleep-wake monitoring. Objective: The goal of this study was to develop a PSG-validated sleep algorithm using accelerometer (ACC) and electrocardiogram (ECG) data from a wearable patch to accurately quantify sleep in a real-world setting. Methods: In this noninterventional, nonsignificant-risk, abbreviated investigational device exemption, single-site study, participants wore the reusable wearable sensor version 2 (RW2) patch. The RW2 patch is part of a digital medicine system (aripiprazole with sensor) designed to provide objective records of medication ingestion for patients with schizophrenia, bipolar I disorder, and major depressive disorder. This study developed a sleep algorithm from patch data and did not contain any study-related or digitized medication. Patch-acquired ACC and ECG data were compared against PSG data to build machine learning classification models to distinguish periods of wake from sleep. The PSG data provided sleep stage classifications at 30-second intervals, which were combined into 5-minute windows and labeled as sleep or wake based on the majority of sleep stages within the window. ACC and ECG features were derived for each 5-minute window. The algorithm that most accurately predicted sleep parameters against PSG data was compared to commercially available wearable devices to further benchmark model performance. Results: Of 80 participants enrolled, 60 had at least 1 night of analyzable ACC and ECG data (25 healthy volunteers and 35 participants with diagnosed SMI). Overall, 10,574 valid 5-minute windows were identified (5854 from participants with SMI), and 84% (n=8830) were classified as greater than half sleep. Of the 3 models tested, the conditional random field algorithm provided the most robust sleep-wake classification. Performance was comparable to the middle 50% of commercial devices evaluated in a recent publication, providing a sleep detection performance of 0.93 (sensitivity) and wake detection performance of 0.60 (specificity) at a prediction probability threshold of 0.75. The conditional random field algorithm retained this performance for individual sleep parameters, including total sleep time, sleep efficiency, and wake after sleep onset (within the middle 50% to top 25% of the assessed devices). The only parameter where the model performance was lower was sleep onset latency (within the bottom 25% of all comparator devices). Conclusions: Using industry-best practices, we developed a sleep algorithm for use with the RW2 patch that can accurately detect sleep and wake windows compared to PSG-labeled sleep data. This algorithm may be used for a more complete understanding of well-being for patients with SMI in a real-world setting, without the need for PSG and a sleep lab. %R 10.2196/62959 %U https://mental.jmir.org/2024/1/e62959 %U https://doi.org/10.2196/62959 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 13 %N %P e57271 %T Unveiling the Influence of AI on Advancements in Respiratory Care: Narrative Review %A Alqahtani,Mohammed M %A Alanazi,Abdullah M M %A Algarni,Saleh S %A Aljohani,Hassan %A Alenezi,Faraj K %A F Alotaibi,Tareq %A Alotaibi,Mansour %A K Alqahtani,Mobarak %A Alahmari,Mushabbab %A S Alwadeai,Khalid %A M Alghamdi,Saeed %A Almeshari,Mohammed A %A Alshammari,Turki Faleh %A Mumenah,Noora %A Al Harbi,Ebtihal %A Al Nufaiei,Ziyad F %A Alhuthail,Eyas %A Alzahrani,Esam %A Alahmadi,Husam %A Alarifi,Abdulaziz %A Zaidan,Amal %A T Ismaeil,Taha %+ Department of Respiratory Therapy, College of Applied Medical Sciences, King Saud bin Abdulaziz University for Health Sciences, MC-3129, PO Box 3660, Riyadh, 11481, Saudi Arabia, 966 501407856, Qahtanimoh@ksau-hs.edu.sa %K artificial intelligence %K AI %K respiratory care %K machine learning %K digital health %K narrative review %D 2024 %7 20.12.2024 %9 Review %J Interact J Med Res %G English %X Background: Artificial intelligence is experiencing rapid growth, with continual innovation and advancements in the health care field. Objective: This study aims to evaluate the application of artificial intelligence technologies across various domains of respiratory care. Methods: We conducted a narrative review to examine the latest advancements in the use of artificial intelligence in the field of respiratory care. The search was independently conducted by respiratory care experts, each focusing on their respective scope of practice and area of interest. Results: This review illuminates the diverse applications of artificial intelligence, highlighting its use in areas associated with respiratory care. Artificial intelligence is harnessed across various areas in this field, including pulmonary diagnostics, respiratory care research, critical care or mechanical ventilation, pulmonary rehabilitation, telehealth, public health or health promotion, sleep clinics, home care, smoking or vaping behavior, and neonates and pediatrics. With its multifaceted utility, artificial intelligence can enhance the field of respiratory care, potentially leading to superior health outcomes for individuals under this extensive umbrella. Conclusions: As artificial intelligence advances, elevating academic standards in the respiratory care profession becomes imperative, allowing practitioners to contribute to research and understand artificial intelligence’s impact on respiratory care. The permanent integration of artificial intelligence into respiratory care creates the need for respiratory therapists to positively influence its progression. By participating in artificial intelligence development, respiratory therapists can augment their clinical capabilities, knowledge, and patient outcomes. %M 39705080 %R 10.2196/57271 %U https://www.i-jmr.org/2024/1/e57271 %U https://doi.org/10.2196/57271 %U http://www.ncbi.nlm.nih.gov/pubmed/39705080 %0 Journal Article %@ 2561-3278 %I JMIR Publications %V 9 %N %P e58166 %T User Perceptions of Wearability of Knitted Sensor Garments for Long-Term Monitoring of Breathing Health: Thematic Analysis of Focus Groups and a Questionnaire Survey %A Fobelets,Kristel %A Mohanty,Nikita %A Thielemans,Mara %A Thielemans,Lieze %A Lake-Thompson,Gillian %A Liu,Meijing %A Jopling,Kate %A Yang,Kai %+ Department of Electrical and Electronic Engineering, Imperial College London, Exhibition Road, South Kensington, SW7 2BT, United Kingdom, 44 02075946236, k.fobelets@imperial.ac.uk %K health technology %K wearability of knitted sensors %K focus groups %K asthma observation %K medical device %K wearable device %K medical instrument %K medical equipment %K medical tool %K sensor %K physiological sensor %K focus group %K breathing %K respiratory %K respirology %K lung %K monitoring %K monitor %K health monitoring %D 2024 %7 10.12.2024 %9 Original Paper %J JMIR Biomed Eng %G English %X Background: Long-term unobtrusive monitoring of breathing patterns can potentially give a more realistic insight into the respiratory health of people with asthma or chronic obstructive pulmonary disease than brief tests performed in medical environments. However, it is uncertain whether users would be willing to wear these sensor garments long term. Objective: Our objective was to explore whether users would wear ordinary looking knitted garments with unobtrusive knitted-in breathing sensors long term to monitor their lung health and under what conditions. Methods: Multiple knitted breathing sensor garments, developed and fabricated by the research team, were presented during a demonstration. Participants were encouraged to touch and feel the garments and ask questions. This was followed by two semistructured, independently led focus groups with a total of 16 adults, of whom 4 had asthma. The focus group conversations were recorded and transcribed. Thematic analysis was carried out by three independent researchers in 3 phases consisting of familiarization with the data, independent coding, and overarching theme definition. Participants also completed a web-based questionnaire to probe opinion about wearability and functionality of the garments. Quantitative analysis of the sensors’ performance was mapped to participants’ garment preference to support the feasibility of the technology for long-term wear. Results: Key points extracted from the qualitative data were (1) garments are more likely to be worn if medically prescribed, (2) a cotton vest worn as underwear was preferred, and (3) a breathing crisis warning system was seen as a promising application. The qualitative analysis showed a preference for a loose-fitting garment style with short sleeves (13/16 participants), 11 out of 16 would also wear snug fitting garments and none of the participants would wear tight-fitting garments over a long period of time. In total, 10 out of 16 participants would wear the snug fitting knitted garment for the whole day and 13 out of 16 would be happy to wear it only during the night if not too hot. The sensitivity demands on the knitted wearable sensors can be aligned with most users’ garment preferences (snug fit). Conclusions: There is an overall positive opinion about wearing a knitted sensor garment over a long period of time for monitoring respiratory health. The knit cannot be tight but a snugly fitted vest as underwear in a breathable material is acceptable for most participants. These requirements can be fulfilled with the proposed garments. Participants with asthma supported using it as a sensor garment connected to an asthma attack alert system. %M 39658003 %R 10.2196/58166 %U https://biomedeng.jmir.org/2024/1/e58166 %U https://doi.org/10.2196/58166 %U http://www.ncbi.nlm.nih.gov/pubmed/39658003 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60892 %T Accuracy, Reproducibility, and Responsiveness to Treatment of Home Spirometry in Cystic Fibrosis: Multicenter, Retrospective, Observational Study %A Oppelaar,Martinus C %A van Helvoort,Hanneke AC %A Bannier,Michiel AGE %A Reijers,Monique HE %A van der Vaart,Hester %A van der Meer,Renske %A Altenburg,Josje %A Conemans,Lennart %A Rottier,Bart L %A Nuijsink,Marianne %A van den Wijngaart,Lara S %A Merkus,Peter JFM %A Roukema,Jolt %+ Department of Pediatric Pulmonology, Amalia Children's Hospital, Radboud University Medical Center, Geert Grooteplein Zuid 10, Nijmegen, 6500 HB, Netherlands, +31 243614430, marc.oppelaar@radboudumc.nl %K telemonitoring %K digital health %K telespirometry %K remote monitoring %K cystic fibrosis %K pediatrics %K reliability %K mobile phone %K hereditary %K chronic pulmonary inflammation %K pulmonary infections %K morbidity %K mortality %K chronic respiratory disease %D 2024 %7 3.12.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Portable spirometers are increasingly used to measure lung function at home, but doubts about the accuracy of these devices persist. These doubts stand in the way of the digital transition of chronic respiratory disease care, hence there is a need to address the accuracy of home spirometry in routine care across multiple settings and ages. Objective: This study aimed to assess the accuracy, reproducibility, and responsiveness to the treatment of home spirometry in long-term pediatric and adult cystic fibrosis care. Methods: This retrospective observational study was carried out in 5 Dutch cystic fibrosis centers. Home spirometry outcomes (forced expiratory volume in one second [FEV1], and forced vital capacity [FVC]) for 601 anonymized users were collected during 3 years. For 81 users, data on clinic spirometry and elexacaftor/tezacaftor/ivacaftor (ETI) use were available. Accuracy was assessed using Bland-Altman plots for paired clinic-home measurements on the same day and within 7 days of each other (nearest neighbor). Intratest reproducibility was assessed using the American Thoracic Society/European Respiratory Society repeatability criteria, the coefficient of variation, and spirometry quality grades. Responsiveness was measured by the percentage change in home spirometry outcomes after the start of ETI. Results: Bland-Altman analysis was performed for 86 same-day clinic-home spirometry pairs and for 263 nearest neighbor clinic-home spirometry pairs (n=81). For both sets and for both FEV1 and FVC, no heteroscedasticity was present and hence the mean bias was expressed as an absolute value. Overall, home spirometry was significantly lower than clinic spirometry (mean ΔFEV1clinic-home 0.13 L, 95% CI 0.10 to 0.19; mean ΔFVCclinic-home 0.20 L, 95% CI 0.14 to 0.25) and remained lower than clinic spirometry independent of age and experience. One-way ANOVA with post hoc comparisons showed significantly lower differences in clinic-home spirometry in adults than in children (Δmean 0.11, 95% CI –0.20 to –0.01) and teenagers (Δmean 0.14, 95% CI –0.25 to –0.02). For reproducibility analyses, 2669 unique measurement days of 311 individuals were included. Overall, 87.3% (2331/2669) of FEV1 measurements and 74.3% (1985/2669) of FVC measurements met reproducibility criteria. Kruskal-Wallis with pairwise comparison demonstrated that for both FVC and FEV1, coefficient of variation was significantly lower in adults than in children and teenagers. A total of 5104 unique home measurements were graded. Grade E was given to 2435 tests as only one home measurement was performed. Of the remaining 2669 tests, 43.8% (1168/2669) and 43.6% (1163/2669) received grade A and B, respectively. The median percentage change in FEV1 from baseline after initiation of ETI was 19.2% after 7-14 days and remained stable thereafter (n=33). Conclusions: Home spirometry is feasible but not equal to clinic spirometry. Home spirometry can confirm whether lung functions remain stable, but the context of measurement and personal trends are more relevant than absolute outcomes. %M 39626236 %R 10.2196/60892 %U https://www.jmir.org/2024/1/e60892 %U https://doi.org/10.2196/60892 %U http://www.ncbi.nlm.nih.gov/pubmed/39626236 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 12 %N %P e55231 %T Incorporating an Intelligent Tutoring System Into a Game-Based Auditory Rehabilitation Training for Adult Cochlear Implant Recipients: Algorithm Development and Validation %A Gnadlinger,Florian %A Werminghaus,Maika %A Selmanagić,André %A Filla,Tim %A Richter,Jutta G %A Kriglstein,Simone %A Klenzner,Thomas %+ Faculty of Informatics, Masaryk University, Botanická 68a, Brno, 602 00, Czech Republic, 420 549 49 ext 4382, florian.gnadlinger@mail.muni.cz %K cochlear implant %K eHealth %K evidence-centered design %K hearing rehabilitation %K adaptive learning %K intelligent tutoring system %K game-based learning %D 2024 %7 3.12.2024 %9 Original Paper %J JMIR Serious Games %G English %X Background: Cochlear implants are implanted hearing devices; instead of amplifying sounds like common hearing aids, this technology delivers preprocessed sound information directly to the hearing (ie, auditory) nerves. After surgery and the first cochlear implant activation, patients must practice interpreting the new auditory sensations, especially for language comprehension. This rehabilitation process is accompanied by hearing therapy through face-to-face training with a therapist, self-directed training, and computer-based auditory training. Objective: In general, self-directed, computer-based auditory training tasks have already shown advantages. However, compliance of cochlear implant recipients is still a major factor, especially for self-directed training at home. Hence, we aimed to explore the combination of 2 techniques to enhance learner motivation in this context: adaptive learning (in the form of an intelligent tutoring system) and game-based learning (in the form of a serious game). Methods: Following the suggestions of the evidence-centered design framework, a domain analysis of hearing therapy was conducted, allowing us to partially describe human hearing skill as a probabilistic competence model (Bayesian network). We developed an algorithm that uses such a model to estimate the current competence level of a patient and create training recommendations. For training, our developed task system was based on 7 language comprehension task types that act as a blueprint for generating tasks of diverse difficulty automatically. To achieve this, 1053 audio assets with meta-information labels were created. We embedded the adaptive task system into a graphic novel–like mobile serious game. German-speaking cochlear implant recipients used the system during a feasibility study for 4 weeks. Results: The 23 adult participants (20 women; 3 men) fulfilled 2259 tasks. In total, 2004 (90.5%) tasks were solved correctly, and 255 (9.5%) tasks were solved incorrectly. A generalized additive model analysis of these tasks indicated that the system adapted to the estimated competency levels of the cochlear implant recipients more quickly in the beginning than at the end. Compared with a uniform distribution of all task types, the recommended task types differed (χ²6=86.713; P<.001), indicating that the system selected specific task types for each patient. This is underlined by the identified categories for the error proportions of the task types. Conclusions: This contribution demonstrates the feasibility of combining an intelligent tutoring system with a serious game in cochlear implant rehabilitation therapies. The findings presented here could lead to further advances in cochlear implant care and aural rehabilitation in general. Trial Registration: German Clinical Trials Register (DRKS) DRKS00022860; https://drks.de/search/en/trial/DRKS00022860 %M 39626219 %R 10.2196/55231 %U https://games.jmir.org/2024/1/e55231 %U https://doi.org/10.2196/55231 %U http://www.ncbi.nlm.nih.gov/pubmed/39626219 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 11 %N %P e55776 %T Navigation Training for Persons With Visual Disability Through Multisensory Assistive Technology: Mixed Methods Experimental Study %A Ricci,Fabiana Sofia %A Liguori,Lorenzo %A Palermo,Eduardo %A Rizzo,John-Ross %A Porfiri,Maurizio %+ Center for Urban Science and Progress, New York University Tandon School of Engineering, Brooklyn, New York, NY, United States, 1 646 997 3681, mporfiri@nyu.edu %K assistive technology %K human-computer interaction %K multisensory feedback %K virtual reality %K visual impairment %K haptic %D 2024 %7 18.11.2024 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Visual disability is a growing problem for many middle-aged and older adults. Conventional mobility aids, such as white canes and guide dogs, have notable limitations that have led to increasing interest in electronic travel aids (ETAs). Despite remarkable progress, current ETAs lack empirical evidence and realistic testing environments and often focus on the substitution or augmentation of a single sense. Objective: This study aims to (1) establish a novel virtual reality (VR) environment to test the efficacy of ETAs in complex urban environments for a simulated visual impairment (VI) and (2) evaluate the impact of haptic and audio feedback, individually and combined, on navigation performance, movement behavior, and perception. Through this study, we aim to address gaps to advance the pragmatic development of assistive technologies (ATs) for persons with VI. Methods: The VR platform was designed to resemble a subway station environment with the most common challenges faced by persons with VI during navigation. This environment was used to test our multisensory, AT-integrated VR platform among 72 healthy participants performing an obstacle avoidance task while experiencing symptoms of VI. Each participant performed the task 4 times: once with haptic feedback, once with audio feedback, once with both feedback types, and once without any feedback. Data analysis encompassed metrics such as completion time, head and body orientation, and trajectory length and smoothness. To evaluate the effectiveness and interaction of the 2 feedback modalities, we conducted a 2-way repeated measures ANOVA on continuous metrics and a Scheirer-Ray-Hare test on discrete ones. We also conducted a descriptive statistical analysis of participants’ answers to a questionnaire, assessing their experience and preference for feedback modalities. Results: Results from our study showed that haptic feedback significantly reduced collisions (P=.05) and the variability of the pitch angle of the head (P=.02). Audio feedback improved trajectory smoothness (P=.006) and mitigated the increase in the trajectory length from haptic feedback alone (P=.04). Participants reported a high level of engagement during the experiment (52/72, 72%) and found it interesting (42/72, 58%). However, when it came to feedback preferences, less than half of the participants (29/72, 40%) favored combined feedback modalities. This indicates that a majority preferred dedicated single modalities over combined ones. Conclusions: AT is crucial for individuals with VI; however, it often lacks user-centered design principles. Research should prioritize consumer-oriented methodologies, testing devices in a staged manner with progression toward more realistic, ecologically valid settings to ensure safety. Our multisensory, AT-integrated VR system takes a holistic approach, offering a first step toward enhancing users’ spatial awareness, promoting safer mobility, and holds potential for applications in medical treatment, training, and rehabilitation. Technological advancements can further refine such devices, significantly improving independence and quality of life for those with VI. %M 39556804 %R 10.2196/55776 %U https://rehab.jmir.org/2024/1/e55776 %U https://doi.org/10.2196/55776 %U http://www.ncbi.nlm.nih.gov/pubmed/39556804 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e54746 %T Comparison of Auscultation Quality Using Contemporary Digital Stethoscopes %A Saraya,Norah %A McBride,Jonathon %A Singh,Karandeep %A Sohail,Omar %A Das,Porag Jeet %+ Department of Learning Health Sciences, University of Michigan, North Ingalls Building, 300 N Ingalls St, Ann Arbor, MI, 48109, United States, 1 734 936 1649, karandeep@health.ucsd.edu %K auscultation %K digital stethoscopes %K valvular heart disease %D 2024 %7 8.11.2024 %9 Research Letter %J JMIR Cardio %G English %X %M 39514245 %R 10.2196/54746 %U https://cardio.jmir.org/2024/1/e54746 %U https://doi.org/10.2196/54746 %U http://www.ncbi.nlm.nih.gov/pubmed/39514245 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e54735 %T Using a Quality-Controlled Dataset From ViSi Mobile Monitoring for Analyzing Posture Patterns of Hospitalized Patients: Retrospective Observational Study %A Huang,Emily J %A Chen,Yuexin %A Clark,Clancy J %K posture monitoring %K ViSi mobile %K wearable device %K inpatient %K quality control %K observational study %K monitoring data %K inpatient monitoring %K wearables %K posture %D 2024 %7 6.11.2024 %9 %J JMIR Mhealth Uhealth %G English %X Background: ViSi Mobile has the capability of monitoring a patient’s posture continuously during hospitalization. Analysis of ViSi telemetry data enables researchers and health care providers to quantify an individual patient’s movement and investigate collective patterns of many patients. However, erroneous values can exist in routinely collected ViSi telemetry data. Data must be scrutinized to remove erroneous records before statistical analysis. Objective: The objectives of this study were to (1) develop a data cleaning procedure for a 1-year inpatient ViSi posture dataset, (2) consolidate posture codes into categories, (3) derive concise summary statistics from the continuous monitoring data, and (4) study types of patient posture habits using summary statistics of posture duration and transition frequency. Methods: This study examined the 2019 inpatient ViSi posture records from Atrium Health Wake Forest Baptist Medical Center. First, 2 types of errors, record overlap and time inconsistency, were identified. An automated procedure was designed to search all records for these errors. A data cleaning procedure removed erroneous records. Second, data preprocessing was conducted. Each patient’s categorical time series was simplified by consolidating the 185 ViSi codes into 5 categories (Lying, Reclined, Upright, Unknown, User-defined). A majority vote process was applied to remove bursts of short duration. Third, statistical analysis was conducted. For each patient, summary statistics were generated to measure average time duration of each posture and rate of posture transitions during the whole day and separately during daytime and nighttime. A k-means clustering analysis was performed to divide the patients into subgroups objectively. Results: The analysis used a sample of 690 patients, with a median of 3 days of extensive ViSi monitoring per patient. The median of posture durations was 10.2 hours/day for Lying, 8.0 hours/day for Reclined, and 2.5 hours/day for Upright. Lying had similar percentages of patients in low and high durations. Reclined showed a decrease in patients for higher durations. Upright had its peak at 0‐2 hours, with a decrease for higher durations. Scatter plots showed that patients could be divided into several subgroups with different posture habits. This was reinforced by the k-means analysis, which identified an active subgroup and two sedentary ones with different resting styles. Conclusions: Using a 1-year ViSi dataset from routine inpatient monitoring, we derived summary statistics of posture duration and posture transitions for each patient and analyzed the summary statistics to identify patterns in the patient population. This analysis revealed several types of patient posture habits. Before analysis, we also developed methodology to clean and preprocess routinely collected inpatient ViSi monitoring data, which is a major contribution of this study. The procedure developed for data cleaning and preprocessing can have broad application to other monitoring systems used in hospitals. %R 10.2196/54735 %U https://mhealth.jmir.org/2024/1/e54735 %U https://doi.org/10.2196/54735 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55880 %T The COSMOS Registry of CytoSorb Hemoadsorption Therapy in Critically Ill Patients: Protocol for an International, Prospective Registry %A Taccone,Fabio Silvio %A Brunkhorst,Frank Martin %A Bottari,Gabriella %A Hidalgo,Jorge %A Kribben,Andreas %A Teboul,Jean-Louis %A Tomescu,Dana %A Klaus,Teresa %A Scheier,Joerg %A Deliargyris,Efthymios %A Ferrer,Ricard %+ Intensive Care Department, Vall d'Hebron University Hospital, Shock, Organ Dysfunction and Resuscitation Research Group (SODIR), Pg. de la Vall d'Hebron, 119, Horta-Guinardó, Barcelona, 08035, Spain, 34 934893000, ricard.ferrer@vallhebron.cat %K extracorporeal blood purification %K CytoSorb %K hemoadsorption %K hemoperfusion %K adsorption %K hyperinflammation %K sepsis %K septic shock %K liver failure %K rhabdomyolysis %K hospital care %K mortality %D 2024 %7 5.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Extracorporeal blood purification with CytoSorb has been increasingly used as an adjunctive therapy in several hyperinflammatory critical care conditions, as well as to remove elevated levels of myoglobin or bilirubin in patients with rhabdomyolysis or liver failure. Despite the increasing worldwide use of hemoadsorption, data from large international multicenter studies are still lacking. Objective: The COSMOS (CytoSorb Treatment Of Critically Ill Patients) registry is a company-sponsored registry by CytoSorbents Corporation and CytoSorbents Medical Inc. and will provide a data repository and reporting infrastructure for the surveillance of CytoSorb use in real-world critical care settings in an unselected, critically ill patient population. The gathered data will serve as a comprehensive resource to assess the effects of such therapy on patients’ management. Methods: The international COSMOS registry is collecting prospective data for patients treated with CytoSorb during routine care in various critical care indications, based on the decision of the treating physicians. Data are collected at baseline, during CytoSorb therapy, 24 hours thereafter, at discharge from the intensive care unit and the hospital, and on day 90. Key outcomes assessed include change in inflammatory biomarkers, vasopressor requirements, fluid balance, organ function and organ support, length of intensive care unit and hospital stay, occurrence of adverse events, and mortality. Results: The COSMOS registry started with the inclusion of the first patient on July 15, 2022, and is now actively enrolling in 4 countries (Germany, Spain, Portugal, and Italy), with plans to expand to other countries outside of Europe. An initial readout is planned for presentation at an international Critical Care conference in 2024. Conclusions: The COSMOS registry is intended to provide comprehensive real-world data on patient outcomes with CytoSorb in various critical care indications, thereby contributing to optimization of patient selection, timing of initiation, and dosing of hemoadsorption treatment. Trial Registration: ClinicalTrials.gov NCT05146336; https://clinicaltrials.gov/study/NCT05146336 International Registered Report Identifier (IRRID): DERR1-10.2196/55880 %M 39500494 %R 10.2196/55880 %U https://www.researchprotocols.org/2024/1/e55880 %U https://doi.org/10.2196/55880 %U http://www.ncbi.nlm.nih.gov/pubmed/39500494 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e55754 %T A Compressive Armchair (OTO) to Perform Deep Pressure Therapy in Children With Autism Spectrum Disorder: User-Centered Design and Feasibility Study %A Gargot,Thomas %A Vachaud,Amandine %A Gilard,Clémence %A Audrain,Alexia %A Gomot,Marie %A Guidotti,Marco %A Briend,Frédéric %A Malvy,Joëlle %A Bonnet Brilhault,Frédérique %+ Child and Adolescent Psychiatry Department, University Hospital Tours, 2 Bd Tonnelle, Tours, 37000, France, 33 0234389435, gargot@univ-tours.fr %K deep pressure therapy %K proprioception %K compression %K autism spectrum disorder %D 2024 %7 5.11.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Deep pressure therapy (DPT) is widely used to reduce anxiety in children with autism spectrum disorder (ASD), but evidence of its efficacy is limited. Objective: This study aims to design a usable, nonstigmatizing compressive armchair that can be easily controlled, electronically, by the user. Methods: A user-centered approach was used to assess the usability of the device. Testing was carried out in a day hospital for children with ASD in France, with a convenience sample of children with severe forms of ASD and intellectual deficiency (N=39). The Witteman design guideline was used. The System Usability Scale and time of use were reported. Results: The final product is a compressive armchair designed to be user centered, with 4 different cells that can be inflated to induce tailored pressure on the body. The pressure level is recorded electronically. Usability was between good and excellent. The device was used by 39 children, once or twice weekly, over a period of 31 months. Each session lasted between 3 and 20 minutes. The armchair takes up less space than a hug machine. Performing sessions with the chair is feasible. Conclusions: First clinical impressions show a decrease in anxiety, improved emotional regulation, and improved attention. DPT is widely used in occupational therapy and frequently requested by parents, but efficacy studies are too scarce to make evidence-based recommendations for its use. The results presented here support further controlled efficacy studies of DPT in the treatment of anxiety in children with ASD. %M 39499911 %R 10.2196/55754 %U https://humanfactors.jmir.org/2024/1/e55754 %U https://doi.org/10.2196/55754 %U http://www.ncbi.nlm.nih.gov/pubmed/39499911 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58583 %T Accuracy of a Smart Diaper System for Nursing Home Residents for Automatically Detecting Voided Volume: Instrument Validation Study %A Kim,Jae Heon %A Lee,Ui Cheol %A Jeong,Byeong Hun %A Kang,Byeong Uk %A Shim,Sung Ryul %A Jeong,In Gab %+ Department of Biomedical Informatics, College of Medicine, Konyang University, 158 Gwanjeodong-ro, Seo-gu, Daejeon, 35365, Republic of Korea, 82 6008661, sungryul.shim@gmail.com %K smart diaper %K urinary incontinence %K medical device %K voided volume %K urine output %K nursing home %K older adults %D 2024 %7 24.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Diapers are commonly used by older patients with urination disorders. A smart diaper system (SDS) may be able to estimate the weight of urine comparably to conventional measurements made by weighing diapers. Objective: The aim of the current research is to determine the degree of accuracy of an SDS technology specifically designed for the management of urination routines and the use of incontinence pads in older adults. Methods: From January to December 2022, 97 older patients with at least 1 chronic disease from 3 nursing homes were included. In this study, the SDS was used for 1 month per patient after obtaining their consent; all patients originally used traditional diapers in the nursing home. The index test measured the change in electrical resistance of the SDS and the reference test measured the change in actual urine weight. When measuring the actual urine weight, the degree of absorption was directly confirmed with the naked eye because the expression value varied according to pressure changes caused by the user’s movement or position. The Pearson correlation was used to determine the correlation between the 2 test methods, the intraclass correlation coefficient (ICC) was used to check the degree of agreement between the evaluators, and the Bland-Altman test was used to confirm whether there was a significant difference between the 2 test methods. Results: The average age of the 97 participants was 86.48 (SD 6.26) years, with 10 men and 87 women. There were 73 patients (75%) with hypertension, 86 patients (88%) with dementia, and 86 patients (88%) with 2 or more comorbidities, accounting for the majority. The Pearson correlation coefficient and ICC were 0.971 and 0.985 (P<.001). In the Bland-Altman figure, the difference in the mean between the 2 tests was evenly scattered without showing a specific pattern, indicating that the SDS and actual urine weight were very consistent. The difference between the mean of the 2 tests was –0.045 of the standardized mean difference, and all measurements were located within the 95% CI, so this confirms that the 2 test methods are equivalent. Conclusions: Our study showed a fairly high correlation coefficient and ICC for all patient groups, which reveals that the 2 tests were very consistent and that the SDS can replace traditional diapers, even in a real clinical setting. This study shows the possibility that heath care professionals could be alerted by the SDS to the need for pad replacement due to incontinence, thus avoiding the development of dermatological complications. %M 39447169 %R 10.2196/58583 %U https://formative.jmir.org/2024/1/e58583 %U https://doi.org/10.2196/58583 %U http://www.ncbi.nlm.nih.gov/pubmed/39447169 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e57503 %T Comparison of the Burdens and Attitudes Between Standard and Web-Based Remote Programming for Deep Brain Stimulation in Parkinson Disease: Survey Study %A Wan,Xiaonan %A Lin,Zhengyu %A Duan,Chengcheng %A Zeng,Zhitong %A Zhang,Chencheng %A Li,Dianyou %K remote programming %K Parkinson disease %K deep brain stimulation %K telemedicine %K economic evaluation %D 2024 %7 23.10.2024 %9 %J JMIR Aging %G English %X Background: Remote programming enables physicians to adjust implantable pulse generators over the internet for patients with Parkinson disease who have undergone deep brain stimulation (DBS) surgery. Despite these technological advances, the demand for and attitudes toward remote programming compared with standard programming among patients with Parkinson disease are still not well understood. Objective: This study aims to investigate the preferences and perceptions associated with these 2 programming methods among patients with Parkinson disease through a web-based survey. Methods: A web-based survey was administered to 463 patients with Parkinson disease who have undergone DBS surgery. The survey aimed to assess the burdens associated with postoperative programming and to compare patients’ attitudes toward the 2 different programming methods. Results: A total of 225 patients completed the survey, all of whom had undergone standard programming, while 132 patients had also experienced remote programming. Among those who received standard programming, 191 (85%) patients required the support of more than 1 caregiver, 129 (58%) patients experienced over 2 days of lost work time, 98 (42%) patients incurred expenses ranging from US $42 to US $146, and 14 (6%) patients spent over US $421. Of the 132 patients who had used remote programming, 81 (62%) patients indicated a preference for remote programming in the future. However, challenges with remote programming persisted, including difficulties in obtaining official prescriptions, a lack of medical insurance coverage, and limited medical resources. Conclusions: Postoperative programming of DBS imposes significant burdens on patients and their caregivers during standard programming sessions—burdens that could be mitigated through remote programming. While patient satisfaction with remote programming is high, it is imperative for clinicians to develop personalized programming strategies tailored to the needs of different patients. %R 10.2196/57503 %U https://aging.jmir.org/2024/1/e57503 %U https://doi.org/10.2196/57503 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e62769 %T Impact of Skin Pigmentation on Pulse Oximetry Blood Oxygenation and Wearable Pulse Rate Accuracy: Systematic Review and Meta-Analysis %A Singh,Sanidhya %A Bennett,Miles Romney %A Chen,Chen %A Shin,Sooyoon %A Ghanbari,Hamid %A Nelson,Benjamin W %+ University of Michigan Medical School, 1301 Catherine Street, Ann Arbor, MI, 48109, United States, 1 7349364000, sansin@med.umich.edu %K photoplethysmography %K pulse oximetry %K arterial blood gas %K skin tone %K skin pigmentation %K bias %K digital technology %D 2024 %7 10.10.2024 %9 Review %J J Med Internet Res %G English %X Background: Photoplethysmography (PPG) is a technology routinely used in clinical practice to assess blood oxygenation (SpO2) and pulse rate (PR). Skin pigmentation may influence accuracy, leading to health outcomes disparities. Objective: This systematic review and meta-analysis primarily aimed to evaluate the accuracy of PPG-derived SpO2 and PR by skin pigmentation. Secondarily, we aimed to evaluate statistical biases and the clinical relevance of PPG-derived SpO2 and PR according to skin pigmentation. Methods: We identified 23 pulse oximetry studies (n=59,684; 197,353 paired SpO2-arterial blood observations) and 4 wearable PR studies (n=176; 140,771 paired PPG-electrocardiography observations). We evaluated accuracy according to skin pigmentation group by comparing SpO2 accuracy root-mean-square values to the regulatory threshold of 3% and PR 95% limits of agreement values to +5 or –5 beats per minute (bpm), according to the standards of the American National Standards Institute, Association for the Advancement of Medical Instrumentation, and the International Electrotechnical Commission. We evaluated biases and clinical relevance using mean bias and 95% CI. Results: For SpO2, accuracy root-mean-square values were 3.96%, 4.71%, and 4.15%, and pooled mean biases were 0.70% (95% CI 0.17%-1.22%), 0.27% (95% CI –0.64% to 1.19%), and 1.27% (95% CI 0.58%-1.95%) for light, medium, and dark pigmentation, respectively. For PR, 95% limits of agreement values were from –16.02 to 13.54, from –18.62 to 16.84, and from –33.69 to 32.54, and pooled mean biases were –1.24 (95% CI –5.31 to 2.83) bpm, –0.89 (95% CI –3.70 to 1.93) bpm, and –0.57 (95% CI –9.44 to 8.29) bpm for light, medium, and dark pigmentation, respectively. Conclusions: SpO2 and PR measurements may be inaccurate across all skin pigmentation groups, breaching U.S. Food and Drug Administration guidance and industry standard thresholds. Pulse oximeters significantly overestimate SpO2 for both light and dark skin pigmentation, but this overestimation may not be clinically relevant. PRs obtained from wearables exhibit no statistically or clinically significant bias based on skin pigmentation. %M 39388258 %R 10.2196/62769 %U https://www.jmir.org/2024/1/e62769 %U https://doi.org/10.2196/62769 %U http://www.ncbi.nlm.nih.gov/pubmed/39388258 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e60147 %T Integrating Real-Time Air Quality Monitoring, Ecological Momentary Assessment, and Spirometry to Evaluate Asthma Symptoms: Usability Study %A Polivka,Barbara %A Krueger,Kathryn %A Bimbi,Olivia %A Huntington-Moskos,Luz %A Nyenhuis,Sharmilee %A Cramer,Emily %A Eldeirawi,Kamal %+ School of Nursing, University of Kansas, 3901 Rainbow Blvd., School of Nursing, Kansas City, KS, 66160, United States, 1 9135881630, bpolivka@kumc.edu %K indoor air quality %K asthma %K real-time assessment %K EMA %K ecological momentary assessment %K mobile phone %K monitoring %K air quality %K real time %K spirometry %K acceptability %K usability %K residential toxins %K volatile organic compounds %K VOC %K adult %K female %K women %K college student %D 2024 %7 10.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals are exposed to a variety of indoor residential toxins including volatile organic compounds and particulates. In adults with asthma, such exposures are associated with asthma symptoms, asthma exacerbations, and decreased lung function. However, data on these exposures and asthma-related outcomes are generally collected at different times and not in real time. The integration of multiple platforms to collect real-time data on environmental exposure, asthma symptoms, and lung function has rarely been explored. Objective: This paper describes how adults with asthma perceive the acceptability and usability of three integrated devices: (1) residential indoor air quality monitor, (2) ecological momentary assessment (EMA) surveys delivered via a smartphone app, and (3) home spirometry, over 14 days. Methods: Participants (N=40) with uncontrolled asthma were mailed the Awair Omni indoor air quality monitor, ZEPHYRx home spirometer, and detailed instructions required for the in-home monitoring. The air quality monitor, spirometer, and EMA app were set up and tested during a videoconference or phone orientation with a research team member. Midway through the 14-day data collection period, participants completed an interview about the acceptability of the study devices or apps, instructional materials provided, and the setup process. At the end of the 14-day data collection period, participants completed a modified System Usability Scale. A random sample of 20 participants also completed a phone interview regarding the acceptability of the study and the impact of the study on their asthma. Results: Participants ranged in age from 26 to 77 (mean 45, SD 13.5) years and were primarily female (n=36, 90%), White (n=26, 67%), college graduates (n=25, 66%), and residing in a single-family home (n=30, 75%). Most indicated that the air quality monitor (n=23, 58%), the EMA (n=20, 50%), and the spirometer (n=17, 43%) were easy to set up and use. Challenges with the EMA included repetitive surveys, surveys arriving during the night, and technical issues. While the home spirometer was identified as a plausible means to evaluate lung function in real time, the interpretation of the readings was unclear, and several participants reported side effects from home spirometer use. Overall, the acceptability of the study and the System Usability Scale scores were high. Conclusions: The study devices were highly acceptable and usable. Participant feedback was instrumental in identifying technical challenges that should be addressed in future studies. %M 39388233 %R 10.2196/60147 %U https://formative.jmir.org/2024/1/e60147 %U https://doi.org/10.2196/60147 %U http://www.ncbi.nlm.nih.gov/pubmed/39388233 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 11 %N %P e60035 %T Using Biosensor Devices and Ecological Momentary Assessment to Measure Emotion Regulation Processes: Pilot Observational Study With Dialectical Behavior Therapy %A Rizvi,Shireen L %A Ruork,Allison K %A Yin,Qingqing %A Yeager,April %A Taylor,Madison E %A Kleiman,Evan M %K wearable device %K ecological momentary assessment %K emotion regulation %K psychotherapy mechanisms %K dialectical behavior therapy %K wearable %K wristwatch %K novel technology %K psychological %K treatment %K pilot study %K adult %K personality disorder %K mental health %K mobile phone %K EMA %K observational study %D 2024 %7 9.10.2024 %9 %J JMIR Ment Health %G English %X Background: Novel technologies, such as ecological momentary assessment (EMA) and wearable biosensor wristwatches, are increasingly being used to assess outcomes and mechanisms of change in psychological treatments. However, there is still a dearth of information on the feasibility and acceptability of these technologies and whether they can be reliably used to measure variables of interest. Objective: Our objectives were to assess the feasibility and acceptability of incorporating these technologies into dialectical behavior therapy and conduct a pilot evaluation of whether these technologies can be used to assess emotion regulation processes and associated problems over the course of treatment. Methods: A total of 20 adults with borderline personality disorder were enrolled in a 6-month course of dialectical behavior therapy. For 1 week out of every treatment month, participants were asked to complete EMA 6 times a day and to wear a biosensor watch. Each EMA assessment included measures of several negative affect and suicidal thinking, among other items. We used multilevel correlations to assess the contemporaneous association between electrodermal activity and 11 negative emotional states reported via EMA. A multilevel regression was conducted in which changes in composite ratings of suicidal thinking were regressed onto changes in negative affect. Results: On average, participants completed 54.39% (SD 33.1%) of all EMA (range 4.7%‐92.4%). They also wore the device for an average of 9.52 (SD 6.47) hours per day and for 92.6% of all days. Importantly, no associations were found between emotional state and electrodermal activity, whether examining a composite of all high-arousal negative emotions or individual emotional states (within-person r ranged from −0.026 to −0.109). Smaller changes in negative affect composite scores were associated with greater suicidal thinking ratings at the subsequent timepoint, beyond the effect of suicidal thinking at the initial timepoint. Conclusions: Results indicated moderate overall compliance with EMA and wearing the watch; however, there was no concurrence between EMA and wristwatch data on emotions. This pilot study raises questions about the reliability and validity of these technologies incorporated into treatment studies to evaluate emotion regulation mechanisms. %R 10.2196/60035 %U https://mental.jmir.org/2024/1/e60035 %U https://doi.org/10.2196/60035 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e56547 %T Feasibility of Monitoring Heart and Respiratory Rates Using Nonwearable Devices and Consistency of the Measured Parameters: Pilot Feasibility Study %A Ikuta,Kasumi %A Aishima,Miya %A Noguchi-Watanabe,Maiko %A Fukui,Sakiko %K heart rate %K older adults %K respiratory rate %K nonwearable devices %K vital signs %D 2024 %7 8.10.2024 %9 %J JMIR Hum Factors %G English %X Background: As Japan is the world’s fastest-aging society with a declining population, it is challenging to secure human resources for care providers. Therefore, the Japanese government is promoting digital transformation and the use of nursing care equipment, including nonwearable devices that monitor heart and respiratory rates. However, the feasibility of monitoring heart and respiratory rates with nonwearable devices and the consistency of the rates measured have not been reported. Objective: In this study, we focused on a sheet-type nonwearable device (Safety Sheep Sensor) introduced in many nursing homes. We evaluated the feasibility of monitoring heart rate (HR) and respiratory rate (RR) continuously using nonwearable devices and the consistency of the HR and RR measured. Methods: A sheet-type nonwearable device that measured HR and RR every minute through body vibrations was placed under the mattress of each participant. The participants in study 1 were healthy individuals aged 20‐60 years (n=21), while those in study 2 were older adults living in multidwelling houses and required nursing care (n=20). The HR was measured using standard methods by the nurse and using the wearable device (Silmee Bar-type Lite sensor), and RR was measured by the nurse. The primary outcome was the mean difference in HR and RR between nonwearable devices and standard methods. Results: The mean difference in HR was −0.32 (SD 3.12) in study 1 and 0.04 (SD: 3.98) in study 2; both the differences were within the predefined accepted discrepancies (<5 beats/min). The mean difference in RR was −0.98 (SD 3.01) in study 1 and −0.49 (SD 2.40) in study 2; both the differences were within the predefined accepted discrepancies (3 breaths/min). Conclusions: HR and RR measurements obtained using the nonwearable devices and the standard method were similar. Continuous monitoring of vital signs using nonwearable devices can aid in the early detection of abnormal conditions in older people. %R 10.2196/56547 %U https://humanfactors.jmir.org/2024/1/e56547 %U https://doi.org/10.2196/56547 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e57033 %T User Experience of a Large-Scale Smartphone-Based Observational Study in Multiple Sclerosis: Global, Open-Access, Digital-Only Study %A Galati,Adriano %A Kriara,Lito %A Lindemann,Michael %A Lehner,Rea %A Jones,JB %+ F Hoffmann-La Roche Ltd, Grenzacherstrasse 124, Basel, 4070, Switzerland, 41 61 682 25 79, adriano.galati@roche.com %K smartphone %K multiple sclerosis %K user experience %K retention %K digital health %K digital health technology %K mobile phone %D 2024 %7 11.9.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: The Floodlight Open app is a digital health technology tool (DHTT) that comprises remote, smartphone sensor–based tests (daily activities) for assessing symptoms of multiple sclerosis (MS). User acquisition, engagement, and retention remain a barrier to successfully deploying such tools. Objective: This study aims to quantitatively and qualitatively investigate key user experience (UX) factors associated with the Floodlight Open app. Methods: Floodlight Open is a global, open-access, digital-only study designed to understand the drivers and barriers in deploying a DHTT in a naturalistic setting without supervision and onboarding by a clinician. Daily activities included tests assessing cognition (Information Processing Speed and Information Processing Speed Digit–Digit), hand-motor function (Pinching Test and Draw a Shape Test), and postural stability and gait (Static Balance Test, U-Turn Test, and Two-Minute Walk Test [2MWT]). All daily activities except the 2MWT were taken in a fixed sequence. Qualitative UX was studied through semistructured interviews in a substudy of US participants with MS. The quantitative UX analysis investigated the impact of new UX design features on user engagement and retention in US participants for 3 separate test series: all daily activities included in the fixed sequence (DA), all daily activities included in the fixed sequence except the Static Balance Test and U-Turn Test (DAx), and the 2MWT. Results: The qualitative UX substudy (N=22) revealed the need for 2 new UX design features: a more seamless user journey during the activation process that eliminates the requirement of switching back and forth between the app and the email that the participants received upon registration, and configurable reminders and push notifications to help plan and remind the participants to complete their daily activities. Both UX design features were assessed in the quantitative UX analysis. Introducing the more seamless user journey (original user journey: n=608; more seamless user journey: n=481) improved the conversion rate of participants who enrolled in the study and proceeded to successfully activate the app from 53.9% (328/608) to 74.6% (359/481). Introducing reminders and push notifications (with reminders and notifications: n=350; without reminders and notifications: n=172) improved continuous usage time (proportion of participants with ≥3 consecutive days of usage: DA and DAx: ~30% vs ~12%; 2MWT: ~30% vs ~20%); test completion rates (maximum number of test series completed: DA: 279 vs 64; DAx: 283 vs 126; 2MWT: 302 vs 76); and user retention rates (at day 30: DA: 53/172, 30.8% vs 34/350, 9.7%; DAx: 53/172, 30.8% vs 60/350, 17.1%; 2MWT: 39/172, 22.6% vs 22/350, 6.2%). Inactivity times remained comparable. Conclusions: The remote assessment of MS with DHTTs is a relatively nascent but growing field of research. The continued assessment and improvement of UX design features can play a crucial role in the successful long-term adoption of new DHTTs. %M 39259964 %R 10.2196/57033 %U https://humanfactors.jmir.org/2024/1/e57033 %U https://doi.org/10.2196/57033 %U http://www.ncbi.nlm.nih.gov/pubmed/39259964 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e56669 %T Improving the Social Well-Being of Single Older Adults Using the LOVOT Social Robot: Qualitative Phenomenological Study %A Tan,Cheng Kian %A Lou,Vivian W Q %A Cheng,Clio Yuen Man %A He,Phoebe Chu %A Khoo,Veronica Eng Joo %+ S R Nathan School of Human Development, Singapore University of Social Sciences, 463 Clementi Rd, Singapore, 599494, Singapore, 65 62489777, kelvintanck@suss.edu.sg %K companionship %K older adults %K social well-being %K pets %K social robots %K elderly %K wellbeing %K qualitative research %K robot %K companion %K body temperature %K development %K research design %K design %K interviews %K psychosocial support %K support %K psychosocial %K temperature regulation %K social %K care home %K aging %K ageing %K robotics %K older adults %K well-being %K loneliness %K technology %K mobile phone %D 2024 %7 23.8.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: This study examined the social well-being of single older adults through the companionship of a social robot, LOVOT (Love+Robot; Groove X). It is designed as a companion for older adults, providing love and affection through verbal and physical interaction. We investigated older adults’ perceptions of the technology and how they benefitted from interacting with LOVOT, to guide the future development of social robots. Objective: This study aimed to use a phenomenological research design to understand the participants’ experiences of companionship provided by the social robot. Our research focused on (1) examining the social well-being of single older adults through the companionship of social robots and (2) understanding the perceptions of single older adults when interacting with social robots. Given the prevalence of technology use to support aging, understanding single older adults’ social well-being and their perceptions of social robots is essential to guide future research on and design of social robots. Methods: A total of 5 single women, aged 60 to 75 years, participated in the study. The participants interacted independently with the robot for a week in their own homes and then participated in a poststudy interview to share their experiences. Results: In total, 4 main themes emerged from the participants’ interactions with LOVOT, such as caring for a social robot, comforting presence of the social robot, meaningful connections with the social robot, and preference for LOVOT over pets. Conclusions: The results indicate that single older adults can obtain psychosocial support by interacting with LOVOT. LOVOT is easily accepted as a companion and makes single older adults feel like they have a greater sense of purpose and someone to connect with. This study suggests that social robots can provide companionship to older adults who live alone. Social robots can help alleviate loneliness by allowing single older adults to form social connections with robots as companions. These findings are particularly important given the rapid aging of the population and the increasing number of single-person households in Singapore. %M 39178408 %R 10.2196/56669 %U https://humanfactors.jmir.org/2024/1/e56669 %U https://doi.org/10.2196/56669 %U http://www.ncbi.nlm.nih.gov/pubmed/39178408 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e53811 %T Perceived Benefit and Satisfaction With a Tablet Computer and an Emergency Smartwatch by Older Adults and Their Relatives: Prospective Real-World Pilot Study %A Wiegel,Patrick %A Fotteler,Marina Liselotte %A Kohn,Brigitte %A Mayer,Sarah %A Verri,Filippo Maria %A Dallmeier,Dhayana %A Denkinger,Michael %K assistive technology %K older adults %K caregiver %K benefits %K usability %K gerontechnology %D 2024 %7 2.8.2024 %9 %J JMIR Hum Factors %G English %X Background: Assistive technologies (ATs) have the potential to promote the quality of life and independent living of older adults and, further, to relieve the burden of formal and informal caregivers and relatives. Technological developments over the last decades have led to a boost of available ATs. However, evidence on the benefits and satisfaction with ATs in real-world applications remains scarce. Objective: This prospective, real-world, pilot study tested the perceived benefit and satisfaction with different ATs in the real-world environment. Methods: Community-dwelling adults aged ≥65 and their relatives tested a tablet computer with a simplified interface or a smartwatch with programmable emergency contacts for 8 weeks in their everyday life. Perceived benefits and satisfaction with ATs were assessed by all older adults and their relatives using different assessment tools before and after the intervention. Outcome measures included the Technology Usage Inventory, Quebec User Evaluation of Satisfaction with Assistive Technology 2.0, and Canadian Occupational Performance Measure. Results: A total of 17 older adults (tablet computer: n=8, 47% and smartwatch: n=9, 53%) and 16 relatives (tablet computer: n=7, 44% and smartwatch: n=9, 56%) were included in the study. The number of participants that were frail (according to the Clinical Frailty Scale) and received care was higher in the smartwatch group than in the tablet computer group. Older adults of the smartwatch group reported higher technology acceptance (Technology Usage Inventory) and satisfaction (Quebec User Evaluation of Satisfaction with Assistive Technology 2.0) scores than those of the tablet computer group, although the differences were not significant (all P>.05). In the tablet computer group, relatives had significantly higher ratings on the item intention to use than older adults (t12.3=3.3, P=.006). Identified everyday issues with the Canadian Occupational Performance Measure included contact/communication and entertainment/information for the tablet computer, safety and getting help in emergency situations for the smartwatch, and the usability of the AT for both devices. While the performance (t8=3.5, P=.008) and satisfaction (t8=3.2, P=.01) in these domains significantly improved in the smartwatch group, changes in the tablet computer group were inconsistent (all P>.05). Conclusions: This study highlights the remaining obstacles for the widespread and effective application of ATs in the everyday life of older adults and their relatives. While the results do not provide evidence for a positive effect regarding communication deficits, perceived benefits could be shown for the area of safety. Future research and technical developments need to consider not only the preferences, problems, and goals of older adults but also their relatives and caregivers to improve the acceptability and effectiveness of ATs. %R 10.2196/53811 %U https://humanfactors.jmir.org/2024/1/e53811 %U https://doi.org/10.2196/53811 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e56924 %T The Impact of Information Relevancy and Interactivity on Intensivists’ Trust in a Machine Learning–Based Bacteremia Prediction System: Simulation Study %A Katzburg,Omer %A Roimi,Michael %A Frenkel,Amit %A Ilan,Roy %A Bitan,Yuval %K user-interface design %K user-interface designs %K user interface %K human-automation interaction %K human-automation interactions %K trust in automation %K automation %K human-computer interaction %K human-computer interactions %K human-ML %K human-ML interaction %K human-ML interactions %K decision making %K decision support system %K clinical decision support %K decision support %K decision support systems %K machine learning %K ML %K artificial intelligence %K AI %K machine learning algorithm %K machine learning algorithms %K digitization %K digitization of information %D 2024 %7 1.8.2024 %9 %J JMIR Hum Factors %G English %X Background: The exponential growth in computing power and the increasing digitization of information have substantially advanced the machine learning (ML) research field. However, ML algorithms are often considered “black boxes,” and this fosters distrust. In medical domains, in which mistakes can result in fatal outcomes, practitioners may be especially reluctant to trust ML algorithms. Objective: The aim of this study is to explore the effect of user-interface design features on intensivists’ trust in an ML-based clinical decision support system. Methods: A total of 47 physicians from critical care specialties were presented with 3 patient cases of bacteremia in the setting of an ML-based simulation system. Three conditions of the simulation were tested according to combinations of information relevancy and interactivity. Participants’ trust in the system was assessed by their agreement with the system’s prediction and a postexperiment questionnaire. Linear regression models were applied to measure the effects. Results: Participants’ agreement with the system’s prediction did not differ according to the experimental conditions. However, in the postexperiment questionnaire, higher information relevancy ratings and interactivity ratings were associated with higher perceived trust in the system (P<.001 for both). The explicit visual presentation of the features of the ML algorithm on the user interface resulted in lower trust among the participants (P=.05). Conclusions: Information relevancy and interactivity features should be considered in the design of the user interface of ML-based clinical decision support systems to enhance intensivists’ trust. This study sheds light on the connection between information relevancy, interactivity, and trust in human-ML interaction, specifically in the intensive care unit environment. %R 10.2196/56924 %U https://humanfactors.jmir.org/2024/1/e56924 %U https://doi.org/10.2196/56924 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e53940 %T Effects of User Experience in Automated Information Processing on Perceived Usefulness of Digital Contact-Tracing Apps: Cross-Sectional Survey Study %A Schrills,Tim %A Kojan,Lilian %A Gruner,Marthe %A Calero Valdez,André %A Franke,Thomas %+ Institute for Multimedia and Interactive Systems, Universität zu Lübeck, Ratzeburger Allee 160, Lübeck, 23560, Germany, 49 451 3101 ext 5135, Tim.schrills@uni-luebeck.de %K COVID-19 %K contact tracing %K user experience %K trust %K health information processing %D 2024 %7 25.6.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: In pandemic situations, digital contact tracing (DCT) can be an effective way to assess one’s risk of infection and inform others in case of infection. DCT apps can support the information gathering and analysis processes of users aiming to trace contacts. However, users’ use intention and use of DCT information may depend on the perceived benefits of contact tracing. While existing research has examined acceptance in DCT, automation-related user experience factors have been overlooked. Objective: We pursued three goals: (1) to analyze how automation-related user experience (ie, perceived trustworthiness, traceability, and usefulness) relates to user behavior toward a DCT app, (2) to contextualize these effects with health behavior factors (ie, threat appraisal and moral obligation), and (3) to collect qualitative data on user demands for improved DCT communication. Methods: Survey data were collected from 317 users of a nationwide-distributed DCT app during the COVID-19 pandemic after it had been in app stores for >1 year using a web-based convenience sample. We assessed automation-related user experience. In addition, we assessed threat appraisal and moral obligation regarding DCT use to estimate a partial least squares structural equation model predicting use intention. To provide practical steps to improve the user experience, we surveyed users’ needs for improved communication of information via the app and analyzed their responses using thematic analysis. Results: Data validity and perceived usefulness showed a significant correlation of r=0.38 (P<.001), goal congruity and perceived usefulness correlated at r=0.47 (P<.001), and result diagnosticity and perceived usefulness had a strong correlation of r=0.56 (P<.001). In addition, a correlation of r=0.35 (P<.001) was observed between Subjective Information Processing Awareness and perceived usefulness, suggesting that automation-related changes might influence the perceived utility of DCT. Finally, a moderate positive correlation of r=0.47 (P<.001) was found between perceived usefulness and use intention, highlighting the connection between user experience variables and use intention. Partial least squares structural equation modeling explained 55.6% of the variance in use intention, with the strongest direct predictor being perceived trustworthiness (β=.54; P<.001) followed by moral obligation (β=.22; P<.001). Based on the qualitative data, users mainly demanded more detailed information about contacts (eg, place and time of contact). They also wanted to share information (eg, whether they wore a mask) to improve the accuracy and diagnosticity of risk calculation. Conclusions: The perceived result diagnosticity of DCT apps is crucial for perceived trustworthiness and use intention. By designing for high diagnosticity for the user, DCT apps could improve their support in the action regulation of users, resulting in higher perceived trustworthiness and use in pandemic situations. In general, automation-related user experience has greater importance for use intention than general health behavior or experience. %M 38916941 %R 10.2196/53940 %U https://humanfactors.jmir.org/2024/1/e53940 %U https://doi.org/10.2196/53940 %U http://www.ncbi.nlm.nih.gov/pubmed/38916941 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e56357 %T Interactive Electronic Pegboard for Enhancing Manual Dexterity and Cognitive Abilities: Instrument Usability Study %A Chien,Shih-Ying %A Wong,Alice MK %A Wu,Ching-Yi %A Beckman,Sara L %+ Department of Industrial Design, Chang Gung University, No.259, Wen-Hwa 1st Road, Kweishan, Taoyuan, 333, Taiwan, 886 3 2118800 ext 5669, shihying@mail.cgu.edu.tw %K interactive electronic pegboard %K stroke %K hand dexterity %K cognitive rehabilitation %K system %D 2024 %7 21.6.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Strokes pose a substantial health burden, impacting 1 in 6 people globally. One-tenth of patients will endure a second, often more severe, stroke within a year. Alarmingly, a younger demographic is being affected due to recent lifestyle changes. As fine motor and cognitive issues arise, patient disability as well as the strain on caregivers and health care resources is exacerbated. Contemporary occupational therapy assesses manual dexterity and cognitive functions through object manipulation and pen-and-paper recordings. However, these assessments are typically isolated, which makes it challenging for therapists to comprehensively evaluate specific patient conditions. Furthermore, the reliance on one-on-one training and assessment approaches on manual documentation is inefficient and prone to transcription errors. Objective: This study examines the feasibility of using an interactive electronic pegboard for stroke rehabilitation in clinical settings. Methods: A total of 10 patients with a history of stroke and 10 healthy older individuals were recruited. With a limit of 10 minutes, both groups of participants underwent a series of challenges involving tasks related to manual operation, shape recognition, and color discrimination. All participants underwent the Box and Block Test and the Purdue Pegboard Test to assess manual dexterity, as well as an array of cognitive assessments, including the Trail Making Test and the Mini-Mental Status Examination, which served as a basis to quantify participants’ attention, executive functioning, and cognitive abilities. Results: The findings validate the potential application of an interactive electronic pegboard for stroke rehabilitation in clinical contexts. Significant statistical differences (P<.01) were observed across all assessed variables, including age, Box and Block Test results, Purdue Pegboard Test outcomes, Trail Making Test-A scores, and Mini-Mental Status Examination performance, between patients with a history of stroke and their healthy older counterparts. Functional and task testing, along with questionnaire interviews, revealed that patients with a history of stroke demonstrated prolonged completion times and slightly inferior performance. Nonetheless, most patients perceived the prototype as user-friendly and engaging. Thus, in the context of patient rehabilitation interventions or the evaluation of patient cognition, physical functioning, or manual dexterity assessments, the developed pegboard could potentially serve as a valuable tool for hand function, attention, and cognitive rehabilitation, thereby mitigating the burden on health care professionals. Conclusions: Health care professionals can use digital electronic pegboards not only as a precise one-on-one training tool but also as a flexible system that can be configured for online or offline, single-player or multiplayer use. Through data analysis, a more informed examination of patients’ cognitive and functional issues can be conducted. Importantly, patient records will be fully retained throughout practices, exercises, or tests, and by leveraging the characteristics of big data, patients can receive the most accurate rehabilitation prescriptions, thereby assisting them in obtaining optimal care. %M 38904991 %R 10.2196/56357 %U https://humanfactors.jmir.org/2024/1/e56357 %U https://doi.org/10.2196/56357 %U http://www.ncbi.nlm.nih.gov/pubmed/38904991 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 11 %N %P e59315 %T Enabling People With Intellectual and Sensory Disabilities to Trigger a Tablet’s Delivery of Task Instructions by Walking to the Tablet: Proof-of-Concept Study %A Lancioni,Giulio E %A Singh,Nirbhay N %A O’Reilly,Mark F %A Sigafoos,Jeff %A Alberti,Gloria %A Orlando,Isabella %A Chiariello,Valeria %A Desideri,Lorenzo %+ Lega F D’Oro Research Center, Via Linguetta 3, Osimo, 60027, Italy, 39 3408323465, giulio.lancioni@uniba.it %K technology %K tablet %K task %K instructions %K intellectual disability, visual impairment, hearing impairment %D 2024 %7 12.6.2024 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: People with intellectual and sensory or sensory-motor disabilities tend to have problems performing multistep tasks. To alleviate their problems, technological solutions have been developed that provide task-step instructions. Instructions are generally delivered at people’s request (eg, as they touch an area of a computer or tablet screen) or automatically, at preset intervals. Objective: This study carried out a preliminary assessment of a new tablet-based technology system that presented task-step instructions when participants with intellectual and sensory disabilities walked close to the tablet (ie, did not require participants to perform fine motor responses on the tablet screen). Methods: The system entailed a tablet and a wireless camera and was programmed to present instructions when participants approached the tablet, that is, when the camera positioned in front of the tablet detected them. Two instructions were available for each task step. One instruction concerned the object(s) that the participants were to collect, and the other instruction concerned the “where” and “how” the object(s) collected would need to be used. For 3 of the six participants, the two instructions were presented in succession, with the second instruction presented once the required object(s) had been collected. For the other 3 participants, the two instructions were presented simultaneously. Instructions consisted of pictorial representations combined with brief verbal phrases. The impact of the system was assessed for each of the 2 groups of participants using a nonconcurrent multiple baseline design across individuals. Results: All participants were successful in using the system. Their mean frequency of correct task steps was close to or above 11.5 for tasks including 12 steps. Their level of correct performance tended to be much lower during the baseline phase when they were to receive the task-step instructions from a regular tablet through scrolling responses. Conclusions: The findings, which need to be interpreted with caution given the preliminary nature of the study, suggest that the new tablet-based technology system might be useful for helping people with intellectual and sensory disabilities perform multistep tasks. %M 38865701 %R 10.2196/59315 %U https://rehab.jmir.org/2024/1/e59315 %U https://doi.org/10.2196/59315 %U http://www.ncbi.nlm.nih.gov/pubmed/38865701 %0 Journal Article %@ 2369-2529 %I %V 11 %N %P e54699 %T Understanding the Sociocultural Challenges and Opportunities for Affordable Wearables to Support Poststroke Upper-Limb Rehabilitation: Qualitative Study %A Rony,Rahat Jahangir %A Amir,Shajnush %A Ahmed,Nova %A Atiba,Samuelson %A Verdezoto,Nervo %A Sparkes,Valerie %A Stawarz,Katarzyna %K rehabilitation %K wearables %K upper-limb rehabilitation %K user-centered design %K qualitative %K interviews %K experiences %K attitudes %K perceptions %K digital health %K health technology %K wearable %K user centered design %K design %K home %K stroke %K recovery %K affordable %K low income %K low resource %K Bangladesh %K physiotherapy %D 2024 %7 28.5.2024 %9 %J JMIR Rehabil Assist Technol %G English %X Background: People who survive a stroke in many cases require upper-limb rehabilitation (ULR), which plays a vital role in stroke recovery practices. However, rehabilitation services in the Global South are often not affordable or easily accessible. For example, in Bangladesh, the access to and use of rehabilitation services is limited and influenced by cultural factors and patients’ everyday lives. In addition, while wearable devices have been used to enhance ULR exercises to support self-directed home-based rehabilitation, this has primarily been applied in developed regions and is not common in many Global South countries due to potential costs and limited access to technology. Objective: Our goal was to better understand physiotherapists’, patients’, and caregivers’ experiences of rehabilitation in Bangladesh, existing rehabilitation practices, and how they differ from the rehabilitation approach in the United Kingdom. Understanding these differences and experiences would help to identify opportunities and requirements for developing affordable wearable devices that could support ULR in home settings. Methods: We conducted an exploratory study with 14 participants representing key stakeholder groups. We interviewed physiotherapists and patients in Bangladesh to understand their approaches, rehabilitation experiences and challenges, and technology use in this context. We also interviewed UK physiotherapists to explore the similarities and differences between the 2 countries and identify specific contextual and design requirements for low-cost wearables for ULR. Overall, we remotely interviewed 8 physiotherapists (4 in the United Kingdom, 4 in Bangladesh), 3 ULR patients in Bangladesh, and 3 caregivers in Bangladesh. Participants were recruited through formal communications and personal contacts. Each interview was conducted via videoconference, except for 2 interviews, and audio was recorded with consent. A total of 10 hours of discussions were transcribed. The results were analyzed using thematic analysis. Results: We identified several sociocultural factors that affect ULR and should be taken into account when developing technologies for the home: the important role of family, who may influence the treatment based on social and cultural perceptions; the impact of gender norms and their influence on attitudes toward rehabilitation and physiotherapists; and differences in approach to rehabilitation between the United Kingdom and Bangladesh, with Bangladeshi physiotherapists focusing on individual movements that are necessary to build strength in the affected parts and their British counterparts favoring a more holistic approach. We propose practical considerations and design recommendations for developing ULR devices for low-resource settings. Conclusions: Our work shows that while it is possible to build a low-cost wearable device, the difficulty lies in addressing sociotechnical challenges. When developing new health technologies, it is imperative to not only understand how well they could fit into patients’, caregivers’, and physiotherapists’ everyday lives, but also how they may influence any potential tensions concerning culture, religion, and the characteristics of the local health care system. %R 10.2196/54699 %U https://rehab.jmir.org/2024/1/e54699 %U https://doi.org/10.2196/54699 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e51518 %T Assessing Differences in mHealth Usability and App Experiences Among Young African American Women: Secondary Analysis of a Randomized Controlled Trial %A Opper,Claudia A %A Browne,Felicia A %A Howard,Brittni N %A Zule,William A %A Wechsberg,Wendee M %+ RTI International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC, 27709-2194, United States, 1 919 541 6596, fbrowne@rti.org %K HIV %K Black women %K mobile apps %K social determinants of health %K prevention %K substance use %K usability %D 2024 %7 16.4.2024 %9 Short Paper %J JMIR Hum Factors %G English %X Background: In North Carolina, HIV continues to disproportionately affect young African American women. Although mobile health (mHealth) technology appears to be a tool capable of making public health information more accessible for key populations, previous technology use and social determinants may impact users’ mHealth experiences. Objective: The objective of this study was to evaluate mHealth usability, assessing differences based on previous technology use and social determinants among a sample of African American women in emerging adulthood. Methods: As part of a National Institute on Drug Abuse–funded randomized controlled trial with African American women (aged 18-25 years), counties were assigned to receive an evidence-based HIV risk reduction intervention through mHealth and participants were asked to complete usability surveys at 6- and 12-month follow-ups. Participants’ first survey responses were analyzed through 2-tailed t tests and linear regression models to examine associations with previous technology use and social determinants (P<.05). Results: The mean System Usability Scale (SUS) score was 69.2 (SD 17.9; n=159), which was higher than the threshold of acceptability (68.0). Participants who had previously used a tablet indicated higher usability compared to participants without previous use (mean 72.9, SD 18.1 vs mean 57.6, SD 11.4; P<.001), and participants with previous smartphone use also reported higher usability compared to participants without previous use (mean 71.9, SD 18.3 vs mean 58.0, SD 10.7; P<.001). Differences in SUS scores were observed among those reporting homelessness (mean 58.3, SD 19.0 vs mean 70.8, SD 17.2; P=.01), unemployment (mean 65.9, SD 17.2 vs mean 71.6, SD 18.1; P=.04), or current school enrollment (mean 73.2, SD 18.5 vs mean 65.4, SD 16.5; P=.006). Statistically significant associations were not observed for food insecurity (mean 67.3, SD 18.6 vs mean 69.9, SD 17.7; P=.45). Conclusions: Although above-average usability was observed overall, these findings demonstrate differences in mHealth usability based on past and current life experiences. As mHealth interventions become more prevalent, these findings may have important implications for ensuring that mHealth apps improve the reach of evidence-based interventions. Trial Registration: ClinicalTrials.gov NCT02965014; https://clinicaltrials.gov/study/NCT02965014 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-018-5796-8 %M 38625721 %R 10.2196/51518 %U https://humanfactors.jmir.org/2024/1/e51518 %U https://doi.org/10.2196/51518 %U http://www.ncbi.nlm.nih.gov/pubmed/38625721 %0 Journal Article %@ 2561-3278 %I JMIR Publications %V 9 %N %P e51901 %T Preliminary Assessment of an Ambulatory Device Dedicated to Upper Airway Muscle Training in Patients With Sleep Apnea: Proof-of-Concept Study %A Roberge,Patrice %A Ruel,Jean %A Bégin-Drolet,André %A Lemay,Jean %A Gakwaya,Simon %A Masse,Jean-François %A Sériès,Frédéric %+ Mechanical Engineering Department, Université Laval, 1065 avenue de la Médecine, Quebec City, QC, G1V 0A6, Canada, 1 418 656 2131 ext 412245, Jean.Ruel@gmc.ulaval.ca %K obstructive sleep apnea/hypopnea syndrome %K OSAHS %K myofunctional therapy %K myotherapy %K oral %K orofacial %K myology %K musculature %K labial %K buccal %K lingual %K speech therapy %K physiotherapy %K physical therapy %K oropharyngeal exercises %K oropharyngeal %K pharyngeal %K pharynx %K hypopnea %K lip %K home-based %K portable device %K devices %K ambulatory %K portable %K monitoring %K apnea %K mouth %K lips %K tongue %K facial %K exercise %K exercises %K myofunctional %K continuous monitoring %K sleep-disordered breathing %K sleep %K breathing %K tongue exercise %K lip exercise %K mHealth %K muscle %K muscles %K muscular %K airway %K sleep apnea %D 2024 %7 15.4.2024 %9 Original Paper %J JMIR Biomed Eng %G English %X Background: Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a prevalent condition affecting a substantial portion of the global population, with its prevalence increasing over the past 2 decades. OSAHS is characterized by recurrent upper airway (UA) closure during sleep, leading to significant impacts on quality of life and heightened cardiovascular and metabolic morbidity. Despite continuous positive airway pressure (CPAP) being the gold standard treatment, patient adherence remains suboptimal due to various factors, such as discomfort, side effects, and treatment unacceptability. Objective: Considering the challenges associated with CPAP adherence, an alternative approach targeting the UA muscles through myofunctional therapy was explored. This noninvasive intervention involves exercises of the lips, tongue, or both to improve oropharyngeal functions and mitigate the severity of OSAHS. With the goal of developing a portable device for home-based myofunctional therapy with continuous monitoring of exercise performance and adherence, the primary outcome of this study was the degree of completion and adherence to a 4-week training session. Methods: This proof-of-concept study focused on a portable device that was designed to facilitate tongue and lip myofunctional therapy and enable precise monitoring of exercise performance and adherence. A clinical study was conducted to assess the effectiveness of this program in improving sleep-disordered breathing. Participants were instructed to perform tongue protrusion, lip pressure, and controlled breathing as part of various tasks 6 times a week for 4 weeks, with each session lasting approximately 35 minutes. Results: Ten participants were enrolled in the study (n=8 male; mean age 48, SD 22 years; mean BMI 29.3, SD 3.5 kg/m2; mean apnea-hypopnea index [AHI] 20.7, SD 17.8/hour). Among the 8 participants who completed the 4-week program, the overall compliance rate was 91% (175/192 sessions). For the tongue exercise, the success rate increased from 66% (211/320 exercises; SD 18%) on the first day to 85% (272/320 exercises; SD 17%) on the last day (P=.05). AHI did not change significantly after completion of training but a noteworthy correlation between successful lip exercise improvement and AHI reduction in the supine position was observed (Rs=–0.76; P=.03). These findings demonstrate the potential of the device for accurately monitoring participants’ performance in lip and tongue pressure exercises during myofunctional therapy. The diversity of the training program (it mixed exercises mixed training games), its ability to provide direct feedback for each exercise to the participants, and the easy measurement of treatment adherence are major strengths of our training program. Conclusions: The study’s portable device for home-based myofunctional therapy shows promise as a noninvasive alternative for reducing the severity of OSAHS, with a notable correlation between successful lip exercise improvement and AHI reduction, warranting further development and investigation. %M 38875673 %R 10.2196/51901 %U https://biomedeng.jmir.org/2024/1/e51901 %U https://doi.org/10.2196/51901 %U http://www.ncbi.nlm.nih.gov/pubmed/38875673 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52365 %T Innovative Design and Development of Personalized Ankle-Foot Orthoses for Survivors of Stroke With Equinovarus Foot: Protocol for a Feasibility and Comparative Trial %A Silva,Rui %A Morouço,Pedro %A Lains,Jorge %A Amorim,Paula %A Alves,Nuno %A Veloso,António Prieto %+ Centre for Rapid and Sustainable Product Development, Polytechnic University of Leiria, Rua de Portugal - Zona Industrial, Marinha Grande, 2430-028, Portugal, 351 244 569 441, rui.d.silva@ipleiria.pt %K 3D printing %K 3D scanner %K ankle foot orthosis %K biomechanical analysis %K equinovarus foot %D 2024 %7 2.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Ankle-foot orthoses (AFOs) are vital in gait rehabilitation for patients with stroke. However, many conventional AFO designs may not offer the required precision for optimized patient outcomes. With the advent of 3D scanning and printing technology, there is potential for more individualized AFO solutions, aiming to enhance the rehabilitative process. Objective: This nonrandomized trial seeks to introduce and validate a novel system for AFO design tailored to patients with stroke. By leveraging the capabilities of 3D scanning and bespoke software solutions, the aim is to produce orthoses that might surpass conventional designs in terms of biomechanical effectiveness and patient satisfaction. Methods: A distinctive 3D scanner, complemented by specialized software, will be developed to accurately capture the biomechanical data of leg movements during gait in patients with stroke. The acquired data will subsequently guide the creation of patient-specific AFO designs. These personalized orthoses will be provided to participants, and their efficacy will be compared with traditional AFO models. The qualitative dimensions of this experience will be evaluated using the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) assessment tool. Feedback from health care professionals and the participants will be considered throughout the trial to ensure a rounded understanding of the system’s implications. Results: Spatial-temporal parameters will be statistically compared using paired t tests to determine significant differences between walking with the personalized orthosis, the existing orthosis, and barefoot conditions. Significant differences will be identified based on P values, with P<.05 indicating statistical significance. The Statistical Parametric Mapping method will be applied to graphically compare kinematic and kinetic data across the entire gait cycle. QUEST responses will undergo statistical analysis to evaluate patient satisfaction, with scores ranging from 1 (not satisfied) to 5 (very satisfied). Satisfaction scores will be presented as mean and SD values. Significant variations in satisfaction levels between the personalized and existing orthosis will be assessed using a Wilcoxon signed rank test. The anticipation is that the AFOs crafted through this innovative system will either match or outperform existing orthoses in use, with higher patient satisfaction rates. Conclusions: Embracing the synergy of technology and biomechanics may hold the key to revolutionizing orthotic design, with the potential to set new standards in patient-centered orthotic solutions. However, as with all innovations, a balanced approach, considering both the technological possibilities and individual patient needs, will be paramount to achieving optimal outcomes. International Registered Report Identifier (IRRID): PRR1-10.2196/52365 %M 38564249 %R 10.2196/52365 %U https://www.researchprotocols.org/2024/1/e52365 %U https://doi.org/10.2196/52365 %U http://www.ncbi.nlm.nih.gov/pubmed/38564249 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e54425 %T User Experience Evaluation of a Spinal Surgery Robot: Workload, Usability, and Satisfaction Study %A Choi,Hyeonkyeong %A Kim,Seunghee %A Jang,Wonseuk %+ Department of Medical Device Engineering and Management, Yonsei University College of Medicine, 20 63rd Road, Unju-ro, Gangnam-gu, Seoul, 06229, Republic of Korea, 82 1091485404, WS.JANG@yuhs.ac %K robot spine surgery %K usability %K satisfaction %K System Usability Scale %K surgical navigation systems %K robotics %K surgery %K neurosurgery %D 2024 %7 1.4.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Robotic spine surgery has continued to evolve since its US Food and Drug Administration approval in 2004, with products now including real-time video guidance and navigation during surgery. As the market for robotic surgical devices evolves, it is important to consider usability factors. Objective: The primary objective of this study was to determine the user experience of a surgical-assistive robotic device. The secondary objective was to evaluate workload, usability, the After-Scenario Questionnaire (ASQ), and the System Usability Scale (SUS). In addition, this study compares the workload, usability, and satisfaction survey of the device among different occupational groups using the device. Methods: Doctors (n=15) and nurses (n=15), the intended users of the surgical assistant robot, participated in the usability evaluation. Participants performed essential scenarios for the surgical assistant robot and provided scenario-specific satisfaction (ASQ), workload (NASA Task Load Index), and usability (SUS) scores. Results: Both doctors and nurses had task success rates of 85% or higher for each scenario. ASQ results showed that both doctors and nurses were least satisfied with ease of completing the task of registration (group 1: mean 4.73, SD 1.57 and group 2: mean 4.47, SD 1.8), amount of time it took (group 1: mean 4.47, SD 1.63 and group 2: mean 4.40, SD 2.09), and support information satisfaction (group 1: mean 5.13, SD 1.50 and group 2: mean 5.13, SD 1.89). All participants had low workloads, and the overall Task Load Index score had a P value of .77, which is greater than .05. The SUS results showed that the overall usability mean for doctors was 64.17 (SD 16.52) and the mean for nurses was 61.67 (SD 19.18), with a P value of .84, which is greater than .05, indicating no difference between the 2 groups. Conclusions: In this study, doctors and nurses evaluated the interaction of the device in a simulated environment, the operating room. By evaluating the use experience and usability of the device with real intended users, we can develop a more effective and convenient user interface. %M 38432688 %R 10.2196/54425 %U https://humanfactors.jmir.org/2024/1/e54425 %U https://doi.org/10.2196/54425 %U http://www.ncbi.nlm.nih.gov/pubmed/38432688 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53402 %T Low-Fidelity Prototype of a Sensor-Dependent Interaction Platform: Formative Evaluation With Informal Caregivers of Older Adults With Cognitive Impairment %A Sharma,Nikita %A Grotenhuijs,Karen %A Gemert-Pijnen,J E W C van %A Oinas-Kukkonen,Harri %A Braakman-Jansen,L M A %+ Faculty of Behavioural, Management and Social Sciences, University of Twente, Zilverling, Hallenweg 19,, Enschede, 7522 NH, Netherlands, 31 534899111, n.sharma@utwente.nl %K older adult care %K informal caregivers %K cognitive impairment %K sensing solutions %K information communication platform %K low-fidelity %K lo-fi prototype %D 2024 %7 22.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Unobtrusive sensing technologies developed for monitoring deviant behaviors in older adult care require integration with an interaction platform to facilitate the flow of information between older adults and their caregivers. However, the continuous monitoring capabilities generate a considerable amount of data that must be interpreted, filtered, and personalized before being communicated to the informal caregivers based on their specific care needs and requirements. Objective: For the effective implementation of unobtrusive sensing solutions (USSs) in the care of older adults with cognitive impairment, we aimed to explore the expectations and preconditions regarding the implementation of USSs from the perspective of informal caregivers. Subsequently, we designed and evaluated a low-fidelity prototype of an interaction platform for its conceptual workflow and usability, incorporating persuasive system design features based on the needs and requirements of informal caregivers. Methods: Overall, 6 informal caregivers of older adults with cognitive impairment living alone participated in this qualitative interview study. We explored the expectation and preconditions regarding implementation through open-ended questions and conducted a formative evaluation (usability study with a think-aloud approach) to evaluate the conceptual workflow and used persuasive system design features in the interaction platform. Overall, a combination of inductive and thematic analyses was used to analyze the interviews. Results: The results of this study present both positive and negative outcome expectations regarding the implementation of USSs, highlighting benefits such as objective decision-making and peace of mind and concerns about information overload and the potential substitution of human contact. Strategic information communication agreements between informal and formal caregivers were deemed crucial for the successful implementation of USSs in care. Overall, informal caregivers had a positive experience with the low-fidelity prototype of the interaction platform, particularly valuing the personalization feature. Conclusions: In conclusion, to achieve successful implementation, a holistic design approach is necessary, and equal consideration should be given to the personalization-privacy paradox to balance users’ needs and privacy. %M 38517461 %R 10.2196/53402 %U https://formative.jmir.org/2024/1/e53402 %U https://doi.org/10.2196/53402 %U http://www.ncbi.nlm.nih.gov/pubmed/38517461 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e47809 %T Digital Care Pathway for Patients With Sleep Apnea in Specialized Care: Mixed Methods Study %A Haverinen,Jari %A Harju,Terttu %A Mikkonen,Hanna %A Liljamo,Pia %A Turpeinen,Miia %A Reponen,Jarmo %+ Finnish Coordinating Center for Health Technology Assessment, Oulu University Hospital, Kajaanintie 50, Oulu, PL10, Finland, 358 504095446, jari.haverinen@pohde.fi %K health services %K telehealth %K telemedicine %K health personnel %K sleep apnea syndromes %K mobile phone %D 2024 %7 22.2.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Sleep apnea is a significant public health disorder in Finland, with a prevalence of 3.7%. Continuous positive airway pressure (CPAP) therapy is the first-line treatment for moderate or severe sleep apnea. From November 18, 2019, all patients who started their CPAP therapy at Oulu University Hospital were attached to a sleep apnea digital care pathway (SA-DCP) and were instructed on its use. Some patients still did not use the SA-DCP although they had started their CPAP therapy. Objective: We aimed to study health care professionals’ (HCPs’) perspectives on the SA-DCP and its usefulness for their work; whether the main targets of SA-DCP can be reached: shortening the initial guiding sessions of CPAP therapy, reducing patient calls and contact with HCPs, and improving patients’ adherence to CPAP therapy; and patients’ perspectives on the SA-DCP and its usefulness to them. Methods: Overall, 6 HCPs were interviewed in May and June 2021. The survey for SA-DCP users (58/91, 64%) and SA-DCP nonusers (33/91, 36%) was conducted in 2 phases: from May to August 2021 and January to June 2022. CPAP device remote monitoring data were collected from SA-DCP users (80/170, 47.1%) and SA-DCP nonusers (90/170, 52.9%) in May 2021. The registered phone call data were collected during 2019, 2020, and 2021. Feedback on the SA-DCP was collected from 446 patients between February and March 2022. Results: According to HCPs, introducing the SA-DCP had not yet significantly improved their workload and work practices, but it had brought more flexibility in some communication situations. A larger proportion of SA-DCP users familiarized themselves with prior information about CPAP therapy before the initial guiding session than nonusers (43/58, 74% vs 16/33, 49%; P=.02). Some patients still had not received prior information about CPAP therapy; therefore, most of the sessions were carried out according to their needs. According to the patient survey and remote monitoring data of CPAP devices, adherence to CPAP therapy was high for both SA-DCP users and nonusers. The number of patients’ phone calls to HCPs did not decrease during the study. SA-DCP users perceived their abilities to use information and communications technology to be better than nonusers (mean 4.2, SD 0.8 vs mean 3.2, SD 1.2; P<.001). Conclusions: According to this study, not all the goals set for the introduction of the SA-DCP have been achieved. Despite using the SA-DCP, some patients still wanted to communicate with HCPs by phone. The most significant factors explaining the nonuse of the SA-DCP were lower digital literacy and older age of the patients. In the future, more attention should be paid to these user groups when designing and introducing upcoming digital care pathways. %M 38386368 %R 10.2196/47809 %U https://humanfactors.jmir.org/2024/1/e47809 %U https://doi.org/10.2196/47809 %U http://www.ncbi.nlm.nih.gov/pubmed/38386368 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e49549 %T Development of an App for Symptom Management in Women With Breast Cancer Receiving Maintenance Aromatase Inhibitors: Protocol for a Mixed Methods Feasibility Study %A Lund-Jacobsen,Trine %A Schwarz,Peter %A Martino,Gabriella %A Pappot,Helle %A Piil,Karin %+ Department of Endocrinology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, 2100, Denmark, 45 25318056, trine.lund-jacobsen@regionh.dk %K acceptability %K aromatase inhibitors %K breast cancer %K cancer %K chemotherapy %K disease %K feasibility %K inhibitor %K management %K mHealth %K postmenopausal %K psychosocial %K QoL %K quality of life %K radiation therapy %K symptom management %K symptom %K tool %K treatment %K usability %K user-friendliness %D 2024 %7 15.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients with postmenopausal nonmetastatic estrogen receptor–positive breast cancer often experience a reduced quality of life after primary treatment. The disease and treatment trajectory consists of surgery followed by chemotherapy or radiation therapy. Upon this, maintenance hormone therapy with an aromatase inhibitor can result in several physical and psychosocial symptoms. Optimal symptom control during maintenance therapy is central to maintaining the patient’s quality of life. Objective: This study aims to (1) develop an electronic symptom management tool for patients with postmenopausal early breast cancer receiving maintenance aromatase inhibitors with an endocrine aspect and (2) assess the feasibility, acceptability, and usability of the pilot version of the Bone@BC app. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal nonmetastatic estrogen receptor–positive breast cancer will be explored. Methods: This study follows a multistage research plan. In stage 1, a systematic literature review to establish an overview of aromatase inhibitor–related symptoms reported by postmenopausal women with nonmetastatic estrogen receptor–positive breast cancer will be completed. In stage 2, a comprehensive overview of symptoms related to aromatase inhibitors (letrozole, exemestane, and anastrozole) will be performed (eg, by reviewing medical leaflets and guidelines). In stage 3, an electronic app with a user-friendly Patient Concern Inventory list to comprise symptoms and concerns will be developed. Last, in stage 4, a convergent mixed methods feasibility study of the pilot version of the Bone@BC app will be conducted. A total of 45 patients with postmenopausal nonmetastatic estrogen receptor–positive breast cancer will use the app daily for symptom identification and respond to 6 serial patient-reported outcome measurements for 12 weeks. Finally, semistructured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using preestablished criteria on feasibility and a mixed methods approach for exploring acceptability. A patient advisory board consisting of 5 women with breast cancer is recruited to include their perspectives and experiences in the planning, organization, implementation, and dissemination of the research throughout the project. Results: At the time of submitting this paper (January 2024), a total of 23 patients have been included in the stage 2 medical audit over the recruitment period of 3 months (November 2022 to February 2023), and 19 patients have been enrolled in stage 2, the semistructured patient interviews. Conclusions: This protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect. Trial Registration: ClinicalTrails.gov NCT05367830; https://clinicaltrials.gov/ct2/show/NCT05367830 International Registered Report Identifier (IRRID): DERR1-10.2196/49549 %M 38358787 %R 10.2196/49549 %U https://www.researchprotocols.org/2024/1/e49549 %U https://doi.org/10.2196/49549 %U http://www.ncbi.nlm.nih.gov/pubmed/38358787 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e49316 %T Evaluating Users’ Experiences of a Child Multimodal Wearable Device: Mixed Methods Approach %A McElwain,Nancy L %A Fisher,Meghan C %A Nebeker,Camille %A Bodway,Jordan M %A Islam,Bashima %A Hasegawa-Johnson,Mark %+ Department of Human Development and Family Studies, University of Illinois Urbana-Champaign, 2004 Doris Christopher Hall, 904 West Nevada Street, Urbana, IL, 61801, United States, 1 217 244 7168, mcelwn@illinois.edu %K wearable devices %K multimodal sensing %K user experience %K usability %K privacy %K children %K mobile phone %D 2024 %7 8.2.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Wearable devices permit the continuous, unobtrusive collection of data from children in their natural environments and can transform our understanding of child development. Although the use of wearable devices has begun to emerge in research involving children, few studies have considered families’ experiences and perspectives of participating in research of this kind. Objective: Through a mixed methods approach, we assessed parents’ and children’s experiences of using a new wearable device in the home environment. The wearable device was designed specifically for use with infants and young children, and it integrates audio, electrocardiogram, and motion sensors. Methods: In study 1, semistructured phone interviews were conducted with 42 parents of children aged 1 month to 9.5 years who completed 2 day-long recordings using the device, which the children wore on a specially designed shirt. In study 2, a total of 110 parents of children aged 2 months to 5.5 years responded to a questionnaire assessing their experience of completing 3 day-long device recordings in the home. Guided by the Digital Health Checklist, we assessed parental responses from both studies in relation to the following three key domains: (1) access and usability, (2) privacy, and (3) risks and benefits. Results: In study 1, most parents viewed the device as easy to use and safe and remote visits as convenient. Parents’ views on privacy related to the audio recordings were more varied. The use of machine learning algorithms (vs human annotators) in the analysis of the audio data, the ability to stop recordings at any time, and the view that the recordings reflected ordinary family life were some reasons cited by parents who expressed minimal, if any, privacy concerns. Varied risks and benefits were also reported, including perceived child comfort or discomfort, the need to adjust routines to accommodate the study, the understanding gained from the study procedures, and the parent’s and child’s enjoyment of study participation. In study 2, parents’ ratings on 5 close-ended items yielded a similar pattern of findings. Compared with a “neutral” rating, parents were significantly more likely to agree that (1) device instructions were helpful and clear (t109=−45.98; P<.001), (2) they felt comfortable putting the device on their child (t109=−22.22; P<.001), and (3) they felt their child was safe while wearing the device (t109=−34.48; P<.001). They were also less likely to worry about the audio recordings gathered by the device (t108=6.14; P<.001), whereas parents’ rating of the burden of the study procedures did not differ significantly from a “neutral” rating (t109=−0.16; P=.87). Conclusions: On the basis of parents’ feedback, several concrete changes can be implemented to improve this new wearable platform and, ultimately, parents’ and children’s experiences of using child wearable devices in the home setting. %M 38329785 %R 10.2196/49316 %U https://humanfactors.jmir.org/2024/1/e49316 %U https://doi.org/10.2196/49316 %U http://www.ncbi.nlm.nih.gov/pubmed/38329785 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e47991 %T User Perceptions of Visual Clot in a High-Fidelity Simulation Study: Mixed Qualitative-Quantitative Study %A Gasciauskaite,Greta %A Castellucci,Clara %A Malorgio,Amos %A Budowski,Alexandra D %A Schweiger,Giovanna %A Kolbe,Michaela %A Fries,Daniel %A Grande,Bastian %A Nöthiger,Christoph B %A Spahn,Donat R %A Roche,Tadzio R %A Tscholl,David W %A Akbas,Samira %+ Institute of Anesthesiology, University Hospital Zurich, Raemistrasse 100, Zurich, 8091, Switzerland, 41 432532242, Samira.Akbas@usz.ch %K Visual Clot %K blood coagulation %K blood coagulation test %K hemostasis %K rotational thromboelastometry %K situation awareness %K user-centered design %K visualization %K user %K perception %K interpretation %K thromboelastography %K viscoelastic hemostatic %K technology %K coagulation %K quantitative information %D 2024 %7 11.1.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Viscoelastic hemostatic assays, such as rotational thromboelastometry (ROTEM) or thromboelastography, enable prompt diagnosis and accelerate targeted treatment. However, the complex interpretation of the results remains challenging. Visual Clot—a situation awareness-based visualization technology—was developed to assist clinicians in interpreting viscoelastic tests. Objective: Following a previous high-fidelity simulation study, we analyzed users’ perceptions of the technology, to identify its strengths and limitations from clinicians’ perspectives. Methods: This is a mixed qualitative-quantitative study consisting of interviews and a survey. After solving coagulation scenarios using Visual Clot in high-fidelity simulations, we interviewed anesthesia personnel about the perceived advantages and disadvantages of the new tool. We used a template approach to identify dominant themes in interview responses. From these themes, we defined 5 statements, which were then rated on Likert scales in a questionnaire. Results: We interviewed 77 participants and 23 completed the survey. We identified 9 frequently mentioned topics by analyzing the interview responses. The most common themes were “positive design features,” “intuitive and easy to learn,” and “lack of a quantitative component.” In the survey, 21 respondents agreed that Visual Clot is easy to learn and 16 respondents stated that a combination of Visual Clot and ROTEM would help them manage complex hemostatic situations. Conclusions: A group of anesthesia care providers found Visual Clot well-designed, intuitive, and easy to learn. Participants highlighted its usefulness in emergencies, especially for clinicians inexperienced in coagulation management. However, the lack of quantitative information is an area for improvement. %M 38206666 %R 10.2196/47991 %U https://humanfactors.jmir.org/2024/1/e47991 %U https://doi.org/10.2196/47991 %U http://www.ncbi.nlm.nih.gov/pubmed/38206666 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e46030 %T A Novel Continuous Real-Time Vital Signs Viewer for Intensive Care Units: Design and Evaluation Study %A Yang,Shiming %A Galvagno,Samuel %A Badjatia,Neeraj %A Stein,Deborah %A Teeter,William %A Scalea,Thomas %A Shackelford,Stacy %A Fang,Raymond %A Miller,Catriona %A Hu,Peter %A , %+ Department of Anesthesiology, University of Maryland School of Medicine, 11 S Paca St. LL01, Baltimore, MD, 21201, United States, 1 4103284179, syang@som.umaryland.edu %K clinical decision-making %K health information technology %K intensive care units %K patient care prioritization %K physiological monitoring %K visualization %K vital signs %D 2024 %7 5.1.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Clinicians working in intensive care units (ICUs) are immersed in a cacophony of alarms and a relentless onslaught of data. Within this frenetic environment, clinicians make high-stakes decisions using many data sources and are often oversaturated with information of varying quality. Traditional bedside monitors only depict static vital signs data, and these data are not easily viewable remotely. Clinicians must rely on separate nursing charts—handwritten or electric—to review physiological patterns, including signs of potential clinical deterioration. An automated physiological data viewer has been developed to provide at-a-glance summaries and to assist with prioritizing care for multiple patients who are critically ill. Objective: This study aims to evaluate a novel vital signs viewer system in a level 1 trauma center by subjectively assessing the viewer’s utility in a high-volume ICU setting. Methods: ICU attendings were surveyed during morning rounds. Physicians were asked to conduct rounds normally, using data reported from nurse charts and briefs from fellows to inform their clinical decisions. After the physician finished their assessment and plan for the patient, they were asked to complete a questionnaire. Following completion of the questionnaire, the viewer was presented to ICU physicians on a tablet personal computer that displayed the patient’s physiologic data (ie, shock index, blood pressure, heart rate, temperature, respiratory rate, and pulse oximetry), summarized for up to 72 hours. After examining the viewer, ICU physicians completed a postview questionnaire. In both questionnaires, the physicians were asked questions regarding the patient’s stability, status, and need for a higher or lower level of care. A hierarchical clustering analysis was used to group participating ICU physicians and assess their general reception of the viewer. Results: A total of 908 anonymous surveys were collected from 28 ICU physicians from February 2015 to June 2017. Regarding physicians’ perception of whether the viewer enhanced the ability to assess multiple patients in the ICU, 5% (45/908) strongly agreed, 56.6% (514/908) agreed, 35.3% (321/908) were neutral, 2.9% (26/908) disagreed, and 0.2% (2/908) strongly disagreed. Conclusions: Morning rounds in a trauma center ICU are conducted in a busy environment with many data sources. This study demonstrates that organized physiologic data and visual assessment can improve situation awareness, assist clinicians with recognizing changes in patient status, and prioritize care. %M 38180791 %R 10.2196/46030 %U https://humanfactors.jmir.org/2024/1/e46030 %U https://doi.org/10.2196/46030 %U http://www.ncbi.nlm.nih.gov/pubmed/38180791 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e44619 %T Acceptance and User Experiences of a Wearable Device for the Management of Hospitalized Patients in COVID-19–Designated Wards in Ho Chi Minh City, Vietnam: Action Learning Project %A Luu,An Phuoc %A Nguyen,Truong Thanh %A Cao,Van Thi Cam %A Ha,Trinh Hoang Diem %A Chung,Lien Thi Thu %A Truong,Trung Ngoc %A Nguyen Le Nhu,Tung %A Dao,Khoa Bach %A Nguyen,Hao Van %A Khanh,Phan Nguyen Quoc %A Le,Khanh Thuy Thuy %A Tran,Luu Hoai Bao %A Nhat,Phung Tran Huy %A Tran,Duc Minh %A Lam,Yen Minh %A Thwaites,Catherine Louise %A Mcknight,Jacob %A Vinh Chau,Nguyen Van %A Van Nuil,Jennifer Ilo %A , %+ Oxford University Clinical Research Unit, 764 Vo Van Kiet, Ho Chi Minh City, 70000, Vietnam, 84 362620124, jvannuil@oucru.org %K vital signs %K wearable devices %K action learning %K technology acceptance model %K TAM %K COVID-19 %K user-centered design %K wearables %K remote monitoring %K technology acceptance %K oximeter %D 2024 %7 5.1.2024 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Wearable devices have been used extensively both inside and outside of the hospital setting. During the COVID-19 pandemic, in some contexts, there was an increased need to remotely monitor pulse and saturated oxygen for patients due to the lack of staff and bedside monitors. Objective: A prototype of a remote monitoring system using wearable pulse oximeter devices was implemented at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam, from August to December 2021. The aim of this work was to support the ongoing implementation of the remote monitoring system. Methods: We used an action learning approach with rapid pragmatic methods, including informal discussions and observations as well as a feedback survey form designed based on the technology acceptance model to assess the use and acceptability of the system. Based on these results, we facilitated a meeting using user-centered design principles to explore user needs and ideas about its development in more detail. Results: In total, 21 users filled in the feedback form. The mean technology acceptance model scores ranged from 3.5 (for perceived ease of use) to 4.4 (for attitude) with behavioral intention (3.8) and perceived usefulness (4.2) scoring in between. Those working as nurses scored higher on perceived usefulness, attitude, and behavioral intention than did physicians. Based on informal discussions, we realized there was a mismatch between how we (ie, the research team) and the ward teams perceived the use and wider purpose of the technology. Conclusions: Designing and implementing the devices to be more nurse-centric from their introduction could have helped to increase their efficiency and use during the complex pandemic period. %M 38180799 %R 10.2196/44619 %U https://humanfactors.jmir.org/2024/1/e44619 %U https://doi.org/10.2196/44619 %U http://www.ncbi.nlm.nih.gov/pubmed/38180799 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 10 %N %P e49702 %T A Brain Computer Interface Neuromodulatory Device for Stroke Rehabilitation: Iterative User-Centered Design Approach %A Alder,Gemma %A Taylor,Denise %A Rashid,Usman %A Olsen,Sharon %A Brooks,Thonia %A Terry,Gareth %A Niazi,Imran Khan %A Signal,Nada %+ Rehabilitation Innovation Centre, Health and Rehabilitation Research Institute, Auckland University of Technology, (A-11), Private Bag 92006, Auckland, 1142, New Zealand, 64 9 921 9999 ext 7815, gemma.alder@aut.ac.nz %K user-centered design %K stroke %K rehabilitation technology %K wearable technology %K brain computer interface %K BCI %K mobile app %K think-aloud %K near live %K semistructured interviews %D 2023 %7 11.12.2023 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Rehabilitation technologies for people with stroke are rapidly evolving. These technologies have the potential to support higher volumes of rehabilitation to improve outcomes for people with stroke. Despite growing evidence of their efficacy, there is a lack of uptake and sustained use in stroke rehabilitation and a call for user-centered design approaches during technology design and development. This study focuses on a novel rehabilitation technology called exciteBCI, a complex neuromodulatory wearable technology in the prototype stage that augments locomotor rehabilitation for people with stroke. The exciteBCI consists of a brain computer interface, a muscle electrical stimulator, and a mobile app. Objective: This study presents the evaluation phase of an iterative user-centered design approach supported by a qualitative descriptive methodology that sought to (1) explore users’ perspectives and experiences of exciteBCI and how well it fits with rehabilitation, and (2) facilitate modifications to exciteBCI design features. Methods: The iterative usability evaluation of exciteBCI was conducted in 2 phases. Phase 1 consisted of 3 sprint cycles consisting of single usability sessions with people with stroke (n=4) and physiotherapists (n=4). During their interactions with exciteBCI, participants used a “think-aloud” approach, followed by a semistructured interview. At the end of each sprint cycle, device requirements were gathered and the device was modified in preparation for the next cycle. Phase 2 focused on a “near-live” approach in which 2 people with stroke and 1 physiotherapist participated in a 3-week program of rehabilitation augmented by exciteBCI (n=3). Participants completed a semistructured interview at the end of the program. Data were analyzed from both phases using conventional content analysis. Results: Overall, participants perceived and experienced exciteBCI positively, while providing guidance for iterative changes. Five interrelated themes were identified from the data: (1) “This is rehab” illustrated that participants viewed exciteBCI as having a good fit with rehabilitation practice; (2) “Getting the most out of rehab” highlighted that exciteBCI was perceived as a means to enhance rehabilitation through increased engagement and challenge; (3) “It is a tool not a therapist,” revealed views that the technology could either enhance or disrupt the therapeutic relationship; and (4) “Weighing up the benefits versus the burden” and (5) “Don’t make me look different” emphasized important design considerations related to device set-up, use, and social acceptability. Conclusions: This study offers several important findings that can inform the design and implementation of rehabilitation technologies. These include (1) the design of rehabilitation technology should support the therapeutic relationship between the patient and therapist, (2) social acceptability is a design priority in rehabilitation technology but its importance varies depending on the use context, and (3) there is value in using design research methods that support understanding usability in the context of sustained use. %M 38079202 %R 10.2196/49702 %U https://rehab.jmir.org/2023/1/e49702 %U https://doi.org/10.2196/49702 %U http://www.ncbi.nlm.nih.gov/pubmed/38079202 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48485 %T Progressive Transition From Supervised to Unsupervised Robot-Assisted Therapy After Stroke: Protocol for a Single-Group, Interventional Feasibility Study %A Devittori,Giada %A Ranzani,Raffaele %A Dinacci,Daria %A Romiti,Davide %A Califfi,Antonella %A Petrillo,Claudio %A Rossi,Paolo %A Gassert,Roger %A Lambercy,Olivier %+ Rehabilitation Engineering Laboratory, Swiss Federal Institute of Technology Zürich, BAA Lengghalde 5, Zurich, 8008, Switzerland, 41 44 510 72 34, giada.devittori@hest.ethz.ch %K technology-assisted rehabilitation %K unsupervised therapy %K self-directed therapy %K stroke %K neurorehabilitation %K neurocognitive rehabilitation %K robot-assisted therapy %K rehabilitation technology %K robot. %D 2023 %7 9.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Increasing the dose of therapy delivered to patients with stroke may improve functional outcomes and quality of life. Unsupervised technology-assisted rehabilitation is a promising way to increase the dose of therapy without dramatically increasing the burden on the health care system. Despite the many existing technologies for unsupervised rehabilitation, active rehabilitation robots have rarely been tested in a fully unsupervised way. Furthermore, the outcomes of unsupervised technology-assisted therapy (eg, feasibility, acceptance, and increase in therapy dose) vary widely. This might be due to the use of different technologies as well as to the broad range of methods applied to teach the patients how to independently train with a technology. Objective: This paper describes the study design of a clinical study investigating the feasibility of unsupervised therapy with an active robot and of a systematic approach for the progressive transition from supervised to unsupervised use of a rehabilitation technology in a clinical setting. The effect of unsupervised therapy on achievable therapy dose, user experience in this therapy setting, and the usability of the rehabilitation technology are also evaluated. Methods: Participants of the clinical study are inpatients of a rehabilitation clinic with subacute stroke undergoing a 4-week intervention where they train with a hand rehabilitation robot. The first week of the intervention is supervised by a therapist, who teaches participants how to interact and train with the device. The second week consists of minimally supervised therapy, where the therapist is present but intervenes only if needed as participants exercise with the device. If the participants properly learn how to train with the device, they proceed to the unsupervised phase and train without any supervision during the third and fourth weeks. Throughout the duration of the study, data on feasibility and therapy dose (ie, duration and repetitions) are collected. Usability and user experience are evaluated at the end of the second (ie, minimally supervised) and fourth (ie, unsupervised) weeks, allowing us to investigate the effect of therapist absence. Results: As of April 2023, 13 patients were recruited and completed the protocol, with no reported adverse events. Conclusions: This study will inform on the feasibility of fully unsupervised rehabilitation with an active rehabilitation robot in a clinical setting and its effect on therapy dose. Furthermore, if successful, the proposed systematic approach for a progressive transition from supervised to unsupervised technology-assisted rehabilitation could serve as a benchmark to allow for easier comparisons between different technologies. This approach could also be extended to the application of such technologies in the home environment, as the supervised and minimally supervised sessions could be performed in the clinic, followed by unsupervised therapy at home after discharge. Trial Registration: ClinicalTrials.gov NCT04388891; https://clinicaltrials.gov/study/NCT04388891 International Registered Report Identifier (IRRID): DERR1-10.2196/48485 %M 37943580 %R 10.2196/48485 %U https://www.researchprotocols.org/2023/1/e48485 %U https://doi.org/10.2196/48485 %U http://www.ncbi.nlm.nih.gov/pubmed/37943580 %0 Journal Article %@ 2561-3278 %I JMIR Publications %V 8 %N %P e46653 %T Development and Testing of a Data Capture Device for Use With Clinical Incentive Spirometers: Testing and Usability Study %A Burns,Michael L %A Sinha,Anik %A Hoffmann,Alexander %A Wu,Zewen %A Medina Inchauste,Tomas %A Retsky,Aaron %A Chesney,David %A Kheterpal,Sachin %A Shah,Nirav %+ Department of Anesthesiology, University of Michigan Health System, 1500 E Medical Center Drive, Ann Arbor, MI, 48109, United States, 1 734 936 4171, mlburns@med.umich.edu %K incentive %K spirometry %K Internet-of-Things %K electronic health records %K web-based intervention %K medical device %K medical tool %K data collection %K spirometry data %K incentive spirometer %K data analysis %K algorithm %K effectiveness %D 2023 %7 7.9.2023 %9 Original Paper %J JMIR Biomed Eng %G English %X Background: The incentive spirometer is a basic and common medical device from which electronic health care data cannot be directly collected. As a result, despite numerous studies investigating clinical use, there remains little consensus on optimal device use and sparse evidence supporting its intended benefits such as prevention of postoperative respiratory complications. Objective: The aim of the study is to develop and test an add-on hardware device for data capture of the incentive spirometer. Methods: An add-on device was designed, built, and tested using reflective optical sensors to identify the real-time location of the volume piston and flow bobbin of a common incentive spirometer. Investigators manually tested sensor level accuracies and triggering range calibrations using a digital flowmeter. A valid breath classification algorithm was created and tested to determine valid from invalid breath attempts. To assess real-time use, a video game was developed using the incentive spirometer and add-on device as a controller using the Apple iPad. Results: In user testing, sensor locations were captured at an accuracy of 99% (SD 1.4%) for volume and 100% accuracy for flow. Median and average volumes were within 7.5% (SD 6%) of target volume sensor levels, and maximum sensor triggering values seldom exceeded intended sensor levels, showing a good correlation to placement on 2 similar but distinct incentive spirometer designs. The breath classification algorithm displayed a 100% sensitivity and a 99% specificity on user testing, and the device operated as a video game controller in real time without noticeable interference or delay. Conclusions: An effective and reusable add-on device for the incentive spirometer was created to allow the collection of previously inaccessible incentive spirometer data and demonstrate Internet-of-Things use on a common hospital device. This design showed high sensor accuracies and the ability to use data in real-time applications, showing promise in the ability to capture currently inaccessible clinical data. Further use of this device could facilitate improved research into the incentive spirometer to improve adoption, incentivize adherence, and investigate the clinical effectiveness to help guide clinical care. %M 38875693 %R 10.2196/46653 %U https://biomedeng.jmir.org/2023/1/e46653 %U https://doi.org/10.2196/46653 %U http://www.ncbi.nlm.nih.gov/pubmed/38875693 %0 Journal Article %@ 2561-9128 %I JMIR Publications %V 6 %N %P e44483 %T Early Warning Scores to Support Continuous Wireless Vital Sign Monitoring for Complication Prediction in Patients on Surgical Wards: Retrospective Observational Study %A van Rossum,Mathilde C %A Bekhuis,Robin E M %A Wang,Ying %A Hegeman,Johannes H %A Folbert,Ellis C %A Vollenbroek-Hutten,Miriam M R %A Kalkman,Cornelis J %A Kouwenhoven,Ewout A %A Hermens,Hermie J %+ Department of Cardiovascular and Respiratory Physiology, University of Twente, PO box 217, Enschede, 7500 AE, Netherlands, 31 53 489 4152, m.c.vanrossum@utwente.nl %K early warning scores %K vital signs %K telemedicine %K physiological monitoring %K clinical alarms %K postoperative complications %K perioperative nursing %D 2023 %7 30.8.2023 %9 Original Paper %J JMIR Perioper Med %G English %X Background: Wireless vital sign sensors are increasingly being used to monitor patients on surgical wards. Although early warning scores (EWSs) are the current standard for the identification of patient deterioration in a ward setting, their usefulness for continuous monitoring is unknown. Objective: This study aimed to explore the usability and predictive value of high-rate EWSs obtained from continuous vital sign recordings for early identification of postoperative complications and compares the performance of a sensor-based EWS alarm system with manual intermittent EWS measurements and threshold alarms applied to individual vital sign recordings (single-parameter alarms). Methods: Continuous vital sign measurements (heart rate, respiratory rate, blood oxygen saturation, and axillary temperature) collected with wireless sensors in patients on surgical wards were used for retrospective simulation of EWSs (sensor EWSs) for different time windows (1-240 min), adopting criteria similar to EWSs based on manual vital signs measurements (nurse EWSs). Hourly sensor EWS measurements were compared between patients with (event group: 14/46, 30%) and without (control group: 32/46, 70%) postoperative complications. In addition, alarms were simulated for the sensor EWSs using a range of alarm thresholds (1-9) and compared with alarms based on nurse EWSs and single-parameter alarms. Alarm performance was evaluated using the sensitivity to predict complications within 24 hours, daily alarm rate, and false discovery rate (FDR). Results: The hourly sensor EWSs of the event group (median 3.4, IQR 3.1-4.1) was significantly higher (P<.004) compared with the control group (median 2.8, IQR 2.4-3.2). The alarm sensitivity of the hourly sensor EWSs was the highest (80%-67%) for thresholds of 3 to 5, which was associated with alarm rates of 2 (FDR=85%) to 1.2 (FDR=83%) alarms per patient per day respectively. The sensitivity of sensor EWS–based alarms was higher than that of nurse EWS–based alarms (maximum=40%) but lower than that of single-parameter alarms (87%) for all thresholds. In contrast, the (false) alarm rates of sensor EWS–based alarms were higher than that of nurse EWS–based alarms (maximum=0.6 alarm/patient/d; FDR=80%) but lower than that of single-parameter alarms (2 alarms/patient/d; FDR=84%) for most thresholds. Alarm rates for sensor EWSs increased for shorter time windows, reaching 70 alarms per patient per day when calculated every minute. Conclusions: EWSs obtained using wireless vital sign sensors may contribute to the early recognition of postoperative complications in a ward setting, with higher alarm sensitivity compared with manual EWS measurements. Although hourly sensor EWSs provide fewer alarms compared with single-parameter alarms, high false alarm rates can be expected when calculated over shorter time spans. Further studies are recommended to optimize care escalation criteria for continuous monitoring of vital signs in a ward setting and to evaluate the effects on patient outcomes. %M 37647104 %R 10.2196/44483 %U https://periop.jmir.org/2023/1/e44483 %U https://doi.org/10.2196/44483 %U http://www.ncbi.nlm.nih.gov/pubmed/37647104 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e44850 %T Perceived Use Cases, Barriers, and Requirements for a Smart Health-Tracking Toilet Seat: Qualitative Focus Group Study %A Hermsen,Sander %A Verbiest,Vera %A Buijs,Marije %A Wentink,Eva %+ OnePlanet Research Center, Bronland 10, Wageningen, 6708 WH, Netherlands, 31 317 791 009, sander.hermsen@imec.nl %K digital health %K internet of things %K human factors %K health tracking %K device %K automated %K biomarker %K personal health %K personal hygiene %K hygiene %K data %K privacy %K innovation %K mobile phone %D 2023 %7 11.8.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Smart bathroom technology offers unrivaled opportunities for the automated measurement of a range of biomarkers and other data. Unfortunately, efforts in this area are mostly driven by a technology push rather than market pull approach, which decreases the chances of successful adoption. As yet, little is known about the use cases, barriers, and desires that potential users of smart bathrooms perceive. Objective: This study aimed to investigate how participants from the general population experience using a smart sensor-equipped toilet seat installed in their home. The study contributes to answering the following questions: What use cases do citizens see for this innovation? and What are the limitations and barriers to its everyday use that they see, including concerns regarding privacy, the lack of fit with everyday practices, and unmet expectations for user experience? Methods: Overall, 31 participants from 30 households participated in a study consisting of 3 (partially overlapping) stages: sensitizing, in which participants filled out questionnaires to trigger their thoughts about smart bathroom use and personal health; provotyping, in which participants received a gentle provocation in the form of a smart toilet seat, which they used for 2 weeks; and discussion, in which participants took part in a web-based focus group session to discuss their experiences. Results: Participants mostly found the everyday use of the toilet, including installation and dismantling when necessary, to be relatively easy and free of complications. Where complications occurred, participants mentioned issues related to the design of the prototype, technology, or mismatches with normal practices in using toilets and hygiene. A broad range of use cases were mentioned, ranging from signaling potentially detrimental health conditions or exacerbations of existing conditions to documenting physical data to measuring biomarkers to inform a diagnosis and behavioral change. Participants differed greatly in whether they let others use, or even know about, the seat. Ownership and control over their own data were essential for most participants. Conclusions: This study showed that participants felt that a smart toilet seat could be acceptable and effective, as long as it fits everyday practices concerning toilet use and hygiene. The range of potential uses for a smart toilet seat is broad, as long as privacy and control over disclosure and data are warranted. %M 37566450 %R 10.2196/44850 %U https://humanfactors.jmir.org/2023/1/e44850 %U https://doi.org/10.2196/44850 %U http://www.ncbi.nlm.nih.gov/pubmed/37566450 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e46893 %T Evaluating the Usefulness and Ease of Use of a Next-Generation–Connected Drug Delivery Device for Growth Hormone Therapy: Qualitative Study of Health Care Professionals’ Perceptions %A Labarta,José I %A Dimitri,Paul %A Keiser,Matthew %A Koledova,Ekaterina %A Rivera-Romero,Octavio %+ Electronic Technology Department, Universidad de Sevilla, Avda. Reina Mercedes s/n, Seville, 41012, Spain, 34 954 55 27 89, orivera@us.es %K connected health %K growth hormone deficiency %K participatory health informatics %K recombinant human growth hormone %K technology acceptance %K mobile phone %D 2023 %7 2.8.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Digital solutions targeting children’s health have become an increasingly important element in the provision of integrated health care. For the treatment of growth hormone deficiency (GHD), a unique connected device is available to facilitate the delivery of recombinant human growth hormone (r-hGH) by automating the daily injection process and collecting injection data such that accurate adherence information is available to health care professionals (HCPs), caregivers, and patients. The adoption of such digital solutions requires a good understanding of the perspectives of HCPs as key stakeholders because they leverage data collection and prescribe these solutions to their patients. Objective: This study aimed to evaluate the third generation of the easypod device (EP3) for the delivery of r-hGH treatment from the HCP perspective, with a focus on perceived usefulness and ease of use. Methods: A qualitative study was conducted, based on a participatory workshop conducted in Zaragoza, Spain, with 10 HCPs experienced in the management of pediatric GHD from 7 reference hospitals in Spain. Several activities were designed to promote discussion among participants about predefined topics based on the Technology Acceptance Model and the Unified Theory of Acceptance and Use of Technology to provide their perceptions about the new device. Results: Participants reported 2 key advantages of EP3 over previous easypod generations: the touch screen interface and the real-time data transmission functionality. All participants (10/10, 100%) agreed that the new device should be part of a digital health ecosystem that provides complementary functionalities including data analysis. Conclusions: This study explored the perceived value of the EP3 autoinjector device for the treatment of GHD by HCPs. HCPs rated the new capabilities of the device as having substantial improvements and concluded that it was highly recommendable for clinical practice. EP3 will enhance decision-making and allow for more personalized care of patients receiving r-hGH. %M 37531173 %R 10.2196/46893 %U https://humanfactors.jmir.org/2023/1/e46893 %U https://doi.org/10.2196/46893 %U http://www.ncbi.nlm.nih.gov/pubmed/37531173 %0 Journal Article %@ 2561-9128 %I JMIR Publications %V 6 %N %P e40474 %T The Accuracy of Wrist-Worn Photoplethysmogram–Measured Heart and Respiratory Rates in Abdominal Surgery Patients: Observational Prospective Clinical Validation Study %A van der Stam,Jonna A %A Mestrom,Eveline H J %A Scheerhoorn,Jai %A Jacobs,Fleur E N B %A Nienhuijs,Simon %A Boer,Arjen-Kars %A van Riel,Natal A W %A de Morree,Helma M %A Bonomi,Alberto G %A Scharnhorst,Volkher %A Bouwman,R Arthur %+ Department of Biomedical Engineering, Eindhoven University of Technology, de Zaale, Eindhoven, 5612 AZ, Netherlands, 31 40 2398675, jonna.vd.stam@catharinaziekenhuis.nl %K Telemetry %K monitoring %K photoplethysmography %K PPG %K photoplethysmogram %K wearable monitoring %K vital parameter %K wearable sensor %K sensor %K heart rate %K respiratory Rate %K respiration %K respiratory %K breathing %K monitoring %K wearable %K postoperative %K post-operative %K vital sign %D 2023 %7 20.2.2023 %9 Original Paper %J JMIR Perioper Med %G English %X Background: Postoperative deterioration is often preceded by abnormal vital parameters. Therefore, vital parameters of postoperative patients are routinely measured by nursing staff. Wrist-worn sensors could potentially provide an alternative tool for the measurement of vital parameters in low-acuity settings. These devices would allow more frequent or even continuous measurements of vital parameters without relying on time-consuming manual measurements, provided their accuracy in this clinical population is established. Objective: This study aimed to assess the accuracy of heart rate (HR) and respiratory rate (RR) measures obtained via a wearable photoplethysmography (PPG) wristband in a cohort of postoperative patients. Methods: The accuracy of the wrist-worn PPG sensor was assessed in 62 post–abdominal surgery patients (mean age 55, SD 15 years; median BMI 34, IQR 25-40 kg/m2). The wearable obtained HR and RR measurements were compared to those of the reference monitor in the postanesthesia or intensive care unit. Bland-Altman and Clarke error grid analyses were performed to determine agreement and clinical accuracy. Results: Data were collected for a median of 1.2 hours per patient. With a coverage of 94% for HR and 34% for RR, the device was able to provide accurate measurements for the large majority of the measurements as 98% and 93% of the measurements were within 5 bpm or 3 rpm of the reference signal. Additionally, 100% of the HR and 98% of the RR measurements were clinically acceptable on Clarke error grid analysis. Conclusions: The wrist-worn PPG device is able to provide measurements of HR and RR that can be seen as sufficiently accurate for clinical applications. Considering the coverage, the device was able to continuously monitor HR and report RR when measurements of sufficient quality were obtained. Trial Registration: ClinicalTrials.gov NCT03923127; https://www.clinicaltrials.gov/ct2/show/NCT03923127 %M 36804173 %R 10.2196/40474 %U https://periop.jmir.org/2023/1/e40474 %U https://doi.org/10.2196/40474 %U http://www.ncbi.nlm.nih.gov/pubmed/36804173 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 4 %P e34823 %T Acceptability and Feasibility of a Low-Cost Device for Gestational Age Assessment in a Low-Resource Setting: Qualitative Study %A Koech,Angela %A Musitia,Peris Muoga %A Mwashigadi,Grace Mkanjala %A Kinshella,Mai-Lei Woo %A Vidler,Marianne %A Temmerman,Marleen %A Craik,Rachel %A von Dadelszen,Peter %A Noble,J Alison %A Papageorghiou,Aris T %A , %+ Centre of Excellence in Women & Child Health, Aga Khan University, 3rd Parklands Avenue, Limuru Road, P.O. Box 30270-00100, Nairobi, 4100, Kenya, 254 722 502602, angela.koech@aku.edu %K gestational age %K gestation %K gynecology %K gynecologist %K prenatal %K antenatal %K maternal %K fetus %K fetal %K ultrasound %K imaging %K pregnancy dating %K handheld %K portable %K trust %K artificial intelligence %K sub-Saharan Africa %K Africa %K low cost %K LMIC %K low income %K feasibility %K acceptability %K AI %K pregnancy %K pregnant %K maternity %K women's health %K obstetrics %K obstetrician %K rural %K remote %K remote location %K misconception %K eHealth %K digital health %D 2022 %7 27.12.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Ultrasound for gestational age (GA) assessment is not routinely available in resource-constrained settings, particularly in rural and remote locations. The TraCer device combines a handheld wireless ultrasound probe and a tablet with artificial intelligence (AI)-enabled software that obtains GA from videos of the fetal head by automated measurements of the fetal transcerebellar diameter and head circumference. Objective: The aim of this study was to assess the perceptions of pregnant women, their families, and health care workers regarding the feasibility and acceptability of the TraCer device in an appropriate setting. Methods: A descriptive study using qualitative methods was conducted in two public health facilities in Kilifi county in coastal Kenya prior to introduction of the new technology. Study participants were shown a video role-play of the use of TraCer at a typical antenatal clinic visit. Data were collected through 6 focus group discussions (N=52) and 18 in-depth interviews. Results: Overall, TraCer was found to be highly acceptable to women, their families, and health care workers, and its implementation at health care facilities was considered to be feasible. Its introduction was predicted to reduce anxiety regarding fetal well-being, increase antenatal care attendance, increase confidence by women in their care providers, as well as save time and cost by reducing unnecessary referrals. TraCer was felt to increase the self-image of health care workers and reduce time spent providing antenatal care. Some participants expressed hesitancy toward the new technology, indicating the need to test its performance over time before full acceptance by some users. The preferred cadre of health care professionals to use the device were antenatal clinic nurses. Important implementation considerations included adequate staff training and the need to ensure sustainability and consistency of the service. Misconceptions were common, with a tendency to overestimate the diagnostic capability, and expectations that it would provide complete reassurance of fetal and maternal well-being and not primarily the GA. Conclusions: This study shows a positive attitude toward TraCer and highlights the potential role of this innovation that uses AI-enabled automation to assess GA. Clarity of messaging about the tool and its role in pregnancy is essential to address misconceptions and prevent misuse. Further research on clinical validation and related usability and safety evaluations are recommended. %M 36574278 %R 10.2196/34823 %U https://humanfactors.jmir.org/2022/4/e34823 %U https://doi.org/10.2196/34823 %U http://www.ncbi.nlm.nih.gov/pubmed/36574278 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 4 %P e42057 %T Usability and Teachability of Continuous Glucose Monitoring Devices in Older Adults and Diabetes Educators: Task Analysis and Ease-of-Use Survey %A Psavko,Simon %A Katz,Noam %A Mirchi,Tina %A Green,Courtney R %+ Dexcom, Inc, 6340 Sequence Dr, San Diego, CA, 92121-4356, United States, 1 858 529 4128, courtney.green@dexcom.com %K medical devices %K wearable devices %K older adults %K task analysis %K usability testing %K continuous glucose monitoring %K glucose monitoring %K glucose levels %K diabetes %K usability %D 2022 %7 15.12.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Continuous glucose monitoring (CGM) devices continuously sense and relay glucose concentration data from the interstitial fluid to a mobile phone or receiver. Older adults benefit from this continuous monitoring of glucose levels. Proper deployment of the sensing wire is facilitated by a specialized applicator. Objective: Our aim was to assess a new seventh-generation (G7) CGM device (Dexcom, Inc) for use by adults 65 years of age or older and certified diabetes care and education specialists (CDCESs). Ease of use related to intradermal insertion and mobile app setup will be assessed and compared to the fifth- and sixth-generation systems. Methods: Formal task analysis was conducted to enumerate the number and complexity of tasks associated with CGM deployment. We recruited 10 older adults with no prior CGM experience and 10 CDCESs to assess ease of use through hands-on insertion and initiation of a G7 system followed by a survey and, for older adults, a system usability scale survey. Results: About half as many tasks are needed to deploy G7 compared to G6. Older adults and CDCESs reported overall high usability of the G7 CGM device. CDCESs noted G7’s easier setup compared to previous generations. The system usability scale score for the CGM system was 92.8, which reflects excellent usability. Conclusions: For CDCESs and for older adults using the G7 CGM system, cognitive burden is relatively low and reduced compared to previous CGM systems. Easing of this burden and simplification of the glucose monitoring aspect of proper diabetes management will likely contribute to improved outcomes in this population. %M 36347498 %R 10.2196/42057 %U https://humanfactors.jmir.org/2022/4/e42057 %U https://doi.org/10.2196/42057 %U http://www.ncbi.nlm.nih.gov/pubmed/36347498 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e37648 %T Differentiated Effects and Determinants of Home Blood Pressure Telemonitoring: Three-Year Cohort Study in Jieshou, Anhui, China %A Xue,Qun %A Zhang,Xuewu %A Liu,Rong %A Guan,Xiaoqin %A Li,Guocheng %A Zhao,Linhai %A Wang,Qian %A Wang,Debin %A Shen,Xingrong %+ School of Health Service Management, Anhui Medical University, 81 Meishan Road, Hefei, 230032, China, 86 13505612172, shenxr@ahmu.edu.cn %K blood pressure %K home telemonitoring %K effect %K influence factors %K China %D 2022 %7 11.10.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Home blood pressure telemonitoring (HBPT) is witnessing rapid diffusion worldwide. Contemporary studies documented mainly short-term (6-12 months) effects of HBPT, and there are limited data about its uptake. Objective: The aim of this study was to explore the 3-year use and determinants of HBPT, and the interactions with systolic and diastolic blood pressure (SBP/DBP) and overall blood pressure (BP) control rate. Methods: HBPT records were obtained from a 3-year cohort of 5658 patients with hypertension in Jieshou, Anhui, China, and data from a structured household survey of a random sample (n=3005) of the cohort. The data analysis comprised (1) timeline trajectories of the rates of monthly active HBPT and mean SBP/DBP for overall and subgroups of patients with varied start-month SBP/DBP; and (2) multivariable linear, logistic, and percentile regression analyses using SBP/DBP, BP control rate, and yearly times of HBPT as the dependent variable, respectively. Results: HBPT was followed by mixed changes in mean monthly SBP/DBP for varied patient groups. The magnitude of changes ranged from –43 to +39 mmHg for SBP and from –27 to +15 mmHg for DBP. The monthly rates of active HBPT all exhibited a rapid and then gradually slower decline. When controlled for commonly reported confounders, times of HBPT in the last year were found to have decreasing correlation coefficients for SBP/DBP (from 0.16 to –0.35 and from 0.11 to –0.35, respectively) and for BP control rate (from 0.53 to –0.62). Conclusions: HBPT had major and “target-converging” effects on SBP/DBP. The magnitude of changes was much greater than commonly reported. BP, variation in BP, and time were the most important determinants of HBPT uptake. Age, education, duration of hypertension, family history, and diagnosis of hypertension complications were also linked to the uptake but at weaker strength. There is a clear need for differentiated thinking over the application and assessment of HBPT, and for identifying and correcting/leveraging potential outdated/new opportunities or beliefs. %M 36114000 %R 10.2196/37648 %U https://www.jmir.org/2022/10/e37648 %U https://doi.org/10.2196/37648 %U http://www.ncbi.nlm.nih.gov/pubmed/36114000 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e38664 %T Development of a Noninvasive Blood Glucose Monitoring System Prototype: Pilot Study %A Valero,Maria %A Pola,Priyanka %A Falaiye,Oluwaseyi %A Ingram,Katherine H %A Zhao,Liang %A Shahriar,Hossain %A Ahamed,Sheikh Iqbal %+ Department of Information Technology, Kennesaw State University, 680 Arntson Drive, Suite J312, Marietta, GA, 30060, United States, 1 470 578 4552, mvalero2@kennesaw.edu %K diabetes %K deep learning %K machine learning %K glucose concentration %K noninvasive monitoring %K optical sensors %K glucose monitoring %D 2022 %7 26.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Diabetes mellitus is a severe disease characterized by high blood glucose levels resulting from dysregulation of the hormone insulin. Diabetes is managed through physical activity and dietary modification and requires careful monitoring of blood glucose concentration. Blood glucose concentration is typically monitored throughout the day by analyzing a sample of blood drawn from a finger prick using a commercially available glucometer. However, this process is invasive and painful, and leads to a risk of infection. Therefore, there is an urgent need for noninvasive, inexpensive, novel platforms for continuous blood sugar monitoring. Objective: Our study aimed to describe a pilot test to test the accuracy of a noninvasive glucose monitoring prototype that uses laser technology based on near-infrared spectroscopy. Methods: Our system is based on Raspberry Pi, a portable camera (Raspberry Pi camera), and a visible light laser. The Raspberry Pi camera captures a set of images when a visible light laser passes through skin tissue. The glucose concentration is estimated by an artificial neural network model using the absorption and scattering of light in the skin tissue. This prototype was developed using TensorFlow, Keras, and Python code. A pilot study was run with 8 volunteers that used the prototype on their fingers and ears. Blood glucose values obtained by the prototype were compared with commercially available glucometers to estimate accuracy. Results: When using images from the finger, the accuracy of the prototype is 79%. Taken from the ear, the accuracy is attenuated to 62%. Though the current data set is limited, these results are encouraging. However, three main limitations need to be addressed in future studies of the prototype: (1) increase the size of the database to improve the robustness of the artificial neural network model; (2) analyze the impact of external factors such as skin color, skin thickness, and ambient temperature in the current prototype; and (3) improve the prototype enclosure to make it suitable for easy finger and ear placement. Conclusions: Our pilot study demonstrates that blood glucose concentration can be estimated using a small hardware prototype that uses infrared images of human tissue. Although more studies need to be conducted to overcome limitations, this pilot study shows that an affordable device can be used to avoid the use of blood and multiple finger pricks for blood glucose monitoring in the diabetic population. %M 36018623 %R 10.2196/38664 %U https://formative.jmir.org/2022/8/e38664 %U https://doi.org/10.2196/38664 %U http://www.ncbi.nlm.nih.gov/pubmed/36018623 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 3 %P e31529 %T Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study %A Schwartz-Lasfargues,Christel %A Roux-Gendron,Camille %A Edomskis,Pim %A Marque,Isabelle %A Bayon,Yves %A Lange,Johan F %A Faucheron,Jean Luc %A Trilling,Bertrand %+ Public Health Department, CHU Grenoble Alpes, Pavillon Taillefer, Grenoble, 38700, France, 33 476767961, imarque1@chu-grenoble.fr %K user-centered design %K usability %K formative evaluation %K medical device %K innovation %K Internet of Things %K IoT %K colorectal surgery %K colorectal anastomotic leakage %K mobile phone %D 2022 %7 8.7.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: A successful innovative medical device is not only technically challenging to develop but must also be readily usable to be integrated into health care professionals’ daily practice. Through a user-centered design (UCD) approach, usability can be improved. However, this type of approach is not widely implemented from the early stages of medical device development. Objective: The case study presented here shows how UCD may be applied at the very early stage of the design of a disruptive medical device used in a complex hospital environment, while no functional device is available yet. The device under study is a connected sensor system to detect colorectal anastomotic leakage, the most detrimental complication following colorectal surgery, which has a high medical cost. We also aimed to provide usability guidelines for the initial design of other innovative medical devices. Methods: UCD was implemented by actively involving health care professionals and all the industrial partners of the project. The methodology was conducted in 2 European hospitals: Grenoble-Alpes University Hospital (France) and Erasmus Medical Center Rotterdam (the Netherlands). A total of 6 elective colorectal procedures and 5 ward shifts were observed. In total, 4 workshops were conducted with project partners and clinicians. A formative evaluation was performed based on 5 usability tests using nonfunctional prototype systems. The case study was completed within 12 months. Results: Functional specifications were defined for the various components of the medical device: device weight, size, design, device attachment, and display module. These specifications consider the future integration of the medical device into current clinical practice (for use in an operating room and patient follow-up inside the hospital) and interactions between surgeons, nurses, nurse assistants, and patients. By avoiding irrelevant technical development, this approach helps to promote cost-effective design. Conclusions: This paper presents the successful deployment over 12 months of a UCD methodology for the design of an innovative medical device during its early development phase. To help in reusing this methodology to design other innovative medical devices, we suggested best practices based on this case. %M 35802406 %R 10.2196/31529 %U https://humanfactors.jmir.org/2022/3/e31529 %U https://doi.org/10.2196/31529 %U http://www.ncbi.nlm.nih.gov/pubmed/35802406 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e36831 %T Use of Health Care Chatbots Among Young People in China During the Omicron Wave of COVID-19: Evaluation of the User Experience of and Satisfaction With the Technology %A Shan,Yi %A Ji,Meng %A Xie,Wenxiu %A Zhang,Xiaomin %A Qian,Xiaobo %A Li,Rongying %A Hao,Tianyong %+ School of Foreign Studies, Nantong University, No. 9, Seyuan Rd, Nantong, 226019, China, 86 15558121896, victorsyhz@hotmail.com %K health care chatbots %K COVID-19 %K user experience %K user satisfaction %K theory of consumption values %K chatbots %K adolescent %K youth %K digital health %K health care %K omicron wave %K omicron %K health care system %K conversational agent %D 2022 %7 9.6.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Long before the outbreak of COVID-19, chatbots had been playing an increasingly crucial role and gaining growing popularity in health care. In the current omicron waves of this pandemic when the most resilient health care systems at the time are increasingly being overburdened, these conversational agents (CA) are being resorted to as preferred alternatives for health care information. For many people, especially adolescents and the middle-aged, mobile phones are the most favored source of information. As a result of this, it is more important than ever to investigate the user experience of and satisfaction with chatbots on mobile phones. Objective: The objective of this study was twofold: (1) Informed by Deneche and Warren’s evaluation framework, Zhu et al’s measures of variables, and the theory of consumption values (TCV), we designed a new assessment model for evaluating the user experience of and satisfaction with chatbots on mobile phones, and (2) we aimed to validate the newly developed model and use it to gain an understanding of the user experience of and satisfaction with popular health care chatbots that are available for use by young people aged 17-35 years in southeast China in self-diagnosis and for acquiring information about COVID-19 and virus variants that are currently spreading. Methods: First, to assess user experience and satisfaction, we established an assessment model based on relevant literature and TCV. Second, the chatbots were prescreened and selected for investigation. Subsequently, 413 informants were recruited from Nantong University, China. This was followed by a questionnaire survey soliciting the participants’ experience of and satisfaction with the selected health care chatbots via wenjuanxing, an online questionnaire survey platform. Finally, quantitative and qualitative analyses were conducted to find the informants’ perception. Results: The data collected were highly reliable (Cronbach α=.986) and valid: communalities=0.632-0.823, Kaiser-Meyer-Olkin (KMO)=0.980, and percentage of cumulative variance (rotated)=75.257% (P<.001). The findings of this study suggest a considerable positive impact of functional, epistemic, emotional, social, and conditional values on the participants’ overall user experience and satisfaction and a positive correlation between these values and user experience and satisfaction (Pearson correlation P<.001). The functional values (mean 1.762, SD 0.630) and epistemic values (mean 1.834, SD 0.654) of the selected chatbots were relatively more important contributors to the students’ positive experience and overall satisfaction than the emotional values (mean 1.993, SD 0.683), conditional values (mean 1.995, SD 0.718), and social values (mean 1.998, SD 0.696). All the participants (n=413, 100%) had a positive experience and were thus satisfied with the selected health care chatbots. The 5 grade categories of participants showed different degrees of user experience and satisfaction: Seniors (mean 1.853, SD 0.108) were the most receptive to health care chatbots for COVID-19 self-diagnosis and information, and second-year graduate candidates (mean 2.069, SD 0.133) were the least receptive; freshmen (mean 1.883, SD 0.114) and juniors (mean 1.925, SD 0.087) felt slightly more positive than sophomores (mean 1.989, SD 0.092) and first-year graduate candidates (mean 1.992, SD 0.116) when engaged in conversations with the chatbots. In addition, female informants (mean 1.931, SD 0.098) showed a relatively more receptive attitude toward the selected chatbots than male respondents (mean 1.999, SD 0.051). Conclusions: This study investigated the use of health care chatbots among young people (aged 17-35 years) in China, focusing on their user experience and satisfaction examined through an assessment framework. The findings show that the 5 domains in the new assessment model all have a positive impact on the participants’ user experience and satisfaction. In this paper, we examined the usability of health care chatbots as well as actual chatbots used for other purposes, enriching the literature on the subject. This study also provides practical implication for designers and developers as well as for governments of all countries, especially in the critical period of the omicron waves of COVID-19 and other future public health crises. %M 35576058 %R 10.2196/36831 %U https://humanfactors.jmir.org/2022/2/e36831 %U https://doi.org/10.2196/36831 %U http://www.ncbi.nlm.nih.gov/pubmed/35576058 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 6 %N 1 %P e35615 %T Surveillance of Arrhythmia in Patients After Myocardial Infarction Using Wearable Electrocardiogram Patch Devices: Prospective Cohort Study %A Kwun,Ju-Seung %A Yoon,Chang-Hwan %A Kim,Sun-Hwa %A Jeon,Ki-Hyun %A Kang,Si-Hyuck %A Lee,Wonjae %A Youn,Tae-Jin %A Chae,In-Ho %+ Seoul National University Bundang Hospital, 82 Gumi-Ro 173 Beon-Gil Bundang-Gu, Gyeonggi-Do, Seongnam-Si, 13620, Republic of Korea, 82 31 787 7052, changhwanyoon@gmail.com %K myocardial infarction %K arrhythmia %K wearable electronic device %K wearable %K ECG %K electrocardiogram %K patch %K patch devices %K atrial fibrillation %K heart %K rhythm %K cardiology %K cardiologist %K cohort study %K tachycardia %K beta-blocker %D 2022 %7 9.6.2022 %9 Original Paper %J JMIR Cardio %G English %X Background: Acute myocardial infarction may be associated with new-onset arrhythmias. Patients with myocardial infarction may manifest serious arrhythmias such as ventricular tachyarrhythmias or atrial fibrillation. Frequent, prolonged electrocardiogram (ECG) monitoring can prevent devastating outcomes caused by these arrhythmias. Objective: We aimed to investigate the incidence of arrhythmias in patients following myocardial infarction using a patch-type device—AT-Patch (ATP-C120; ATsens). Methods: This study is a nonrandomized, single-center, prospective cohort study. We evaluated 71 patients who had had a myocardial infarction and had been admitted to our hospital. The ATP-C120 device was attached to the patient for 11 days and analyzed by 2 cardiologists for new-onset arrhythmic events. Results: One participant was concordantly diagnosed with atrial fibrillation. The cardiologists diagnosed atrial premature beats in 65 (92%) and 60 (85%) of 71 participants, and ventricular premature beats in 38 (54%) and 44 (62%) participants, respectively. Interestingly, 40 (56%) patients showed less than 2 minutes of sustained paroxysmal atrial tachycardia confirmed by both cardiologists. Among participants with atrial tachycardia, the use of β-blockers was significantly lower compared with patients without tachycardia (70% vs 90%, P=.04). However, different dosages of β-blockers did not make a significant difference. Conclusions: Wearable ECG monitoring patch devices are easy to apply and can correlate symptoms and ECG rhythm disturbances in patients following myocardial infarction. Further study is necessary regarding clinical implications and appropriate therapies for arrhythmias detected early after myocardial infarction to prevent adverse outcomes. %M 35679117 %R 10.2196/35615 %U https://cardio.jmir.org/2022/1/e35615 %U https://doi.org/10.2196/35615 %U http://www.ncbi.nlm.nih.gov/pubmed/35679117 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e33706 %T Adoption of a Postoperative Pain Self-Report Tool: Qualitative Study %A Thiel,Bram %A Iao,Inez %A Smid,Joris %A de Wit,Emmy %A Koopman,Seppe %A Geerts,Bart %A Godfried,Marc %A Kalkman,Cor %+ Department of Anesthesiology, OLVG Hospital, Oosterpark 9, Amsterdam, 1091AC, Netherlands, 31 0205994773, b.thiel@olvg.nl %K innovation %K eHealth adoption model, mobile health %K pain %K self-report %K perioperative medicine %K postoperative pain %K surgery %D 2022 %7 26.4.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: With electronic technologies, patients are provided with tools to easily acquire information and to manage and record their own health status. eHealth interventions are already broadly applied to perioperative care. In a similar way, we aimed to utilize a smartphone application to enable postoperative patients to partially self-manage their postoperative pain. The results of a previously performed proof-of-concept study regarding the application were promising, and nurses as well as patients were optimistic regarding this innovative mobile application. Nevertheless, in reality, it appears that the usage and overall implementation of this application have stagnated since its introduction. Problems with innovation adoption are not novel; various studies have been conducted to explore the reasons for low implementation success of eHealth applications and indicated that adoption is influenced by multiple organizational factors. This study investigated the influence of these organizational factors on the adoption process, aiming to provide more insight in the dos and don’ts for implementing eHealth in the working processes of hospital care. Objective: This study aimed to provide insight in how to successfully implement a technological eHealth innovation in a general nonacademic hospital. Methods: A qualitative study was conducted to explore organizational factors affecting the innovation adoption process. Data were collected by conducting semistructured one-on-one interviews with 11 stakeholders. The data were analyzed using thematic analysis identifying overarching themes. Results: Absorptive capacity, referred to as an organization’s dynamic capability pertaining to knowledge creation and utilization that enhances an organization’s ability to gain and sustain a competitive advantage, was regarded as the most influential factor on the application’s adoption. Accordingly, it appeared that innovation adoption is mainly determined by the capability and willingness to assimilate and transform new information into productive use and the ability to absorb a novel innovation. Absorptive capacity was found to be influenced by the innovation’s benefit and the sense of ownership and responsibility. Organizational readiness and management support were also regarded as essential since absorptive capacity seemed to be mediated by these factors. The size of the hospital influenced eHealth adoption by the amount of resources available and by its organizational structure. Conclusions: In conclusion, absorptive capacity is essential for eHealth adoption, and it is mediated by management support and organizational readiness. It is recommended to increase the degree of willingness and ability to adopt an eHealth innovation by enhancing the relevance, engaging stakeholders, and assigning appropriate leaders to offer guidance. %M 35471472 %R 10.2196/33706 %U https://humanfactors.jmir.org/2022/2/e33706 %U https://doi.org/10.2196/33706 %U http://www.ncbi.nlm.nih.gov/pubmed/35471472 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e34677 %T User Perceptions of Different Vital Signs Monitor Modalities During High-Fidelity Simulation: Semiquantitative Analysis %A Akbas,Samira %A Said,Sadiq %A Roche,Tadzio Raoul %A Nöthiger,Christoph B %A Spahn,Donat R %A Tscholl,David W %A Bergauer,Lisa %+ Institute of Anesthesiology, University of Zurich, University Hospital Zurich, Raemistrasse 100, Zurich, 8091, Switzerland, 41 432539451, david.tscholl@usz.ch %K avatar %K patient monitoring %K semiquantitative research %K simulation study %K situation awareness %K user-centered design %K visual-patient-avatar %D 2022 %7 18.3.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Patient safety during anesthesia is crucially dependent on the monitoring of vital signs. However, the values obtained must also be perceived and correctly classified by the attending care providers. To facilitate these processes, we developed Visual-Patient-avatar, an animated virtual model of the monitored patient, which innovatively presents numerical and waveform data following user-centered design principles. After a high-fidelity simulation study, we analyzed the participants’ perceptions of 3 different monitor modalities, including this newly introduced technique. Objective: The aim of this study was to collect and evaluate participants’ opinions and experiences regarding 3 different monitor modalities, which are Visual-Patient-avatar, Split Screen (avatar and Conventional monitor alongside each other), and Conventional monitor after using them during simulated critical anesthetic events. Methods: This study was a researcher-initiated, single-center, semiquantitative study. We asked 92 care providers right after finishing 3 simulated emergency scenarios about their positive and negative opinions concerning the different monitor modalities. We processed the field notes obtained and derived the main categories and corresponding subthemes following qualitative research methods. Results: We gained a total of 307 statements. Through a context-based analysis, we identified the 3 main categories of “Visual-Patient-avatar,” “Split Screen,” and “Conventional monitor” and divided them into 11 positive and negative subthemes. We achieved substantial interrater reliability in assigning the statements to 1 of the topics. Most of the statements concerned the design and usability features of the avatar or the Split Screen mode. Conclusions: This study semiquantitatively reviewed the clinical applicability of the Visual-Patient-avatar technique in a high-fidelity simulation study and revealed the strengths and limitations of the avatar only and Split Screen modality. In addition to valuable suggestions for improving the design, the requirement for training prior to clinical implementation was emphasized. The responses to the Split Screen suggest that this symbiotic modality generates better situation awareness in combination with numerical data and accurate curves. As a subsequent development step, a real-life introduction study is planned, where we will test the avatar in Split Screen mode under actual clinical conditions. %M 35119375 %R 10.2196/34677 %U https://humanfactors.jmir.org/2022/1/e34677 %U https://doi.org/10.2196/34677 %U http://www.ncbi.nlm.nih.gov/pubmed/35119375 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e30091 %T Usability of Wearable Multiparameter Technology to Continuously Monitor Free-Living Vital Signs in People Living With Chronic Obstructive Pulmonary Disease: Prospective Observational Study %A Hawthorne,Grace %A Greening,Neil %A Esliger,Dale %A Briggs-Price,Samuel %A Richardson,Matthew %A Chaplin,Emma %A Clinch,Lisa %A Steiner,Michael C %A Singh,Sally J %A Orme,Mark W %+ Centre for Exercise and Rehabilitation Science, National Institute for Health Research Leicester Biomedical Research Centre – Respiratory, University Hospitals of Leicester National Health Service Trust, Groby Road, Leicester, LE3 9QP, United Kingdom, 44 116258 ext 3035, grace.france1@nhs.net %K chronic obstructive pulmonary disease %K digital health %K physical activity %K respiratory rate %K wearable technology %K wearable device %K vital signs monitor %D 2022 %7 16.2.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Vital signs monitoring (VSM) is routine for inpatients, but monitoring during free-living conditions is largely untested in chronic obstructive pulmonary disease (COPD). Objective: This study investigated the usability and acceptability of continuous VSM for people with COPD using wearable multiparameter technology. Methods: In total, 50 people following hospitalization for an acute exacerbation of COPD (AECOPD) and 50 people with stable COPD symptoms were asked to wear an Equivital LifeMonitor during waking hours for 6 weeks (42 days). The device recorded heart rate (HR), respiratory rate (RR), skin temperature, and physical activity. Adherence was defined by the number of days the vest was worn and daily wear time. Signal quality was examined, with thresholds of ≥85% for HR and ≥80% for RR, based on the device’s proprietary confidence algorithm. Data quality was calculated as the percentage of wear time with acceptable signal quality. Participant feedback was assessed during follow-up phone calls. Results: In total, 84% of participants provided data, with average daily wear time of 11.8 (SD 2.2) hours for 32 (SD 11) days (average of study duration 76%, SD 26%). There was greater adherence in the stable group than in the post-AECOPD group (≥5 weeks wear: 71.4% vs 45.7%; P=.02). For all 84 participants, the median HR signal quality was 90% (IQR 80%-94%) and the median RR signal quality was 93% (IQR 92%-95%). The median HR data quality was 81% (IQR 58%-91%), and the median RR data quality was 85% (IQR 77%-91%). Stable group BMI was associated with HR signal quality (rs=0.45, P=.008) and HR data quality (rs=0.44, P=.008). For the AECOPD group, RR data quality was associated with waist circumference and BMI (rs=–0.49, P=.009; rs=–0.44, P=.02). In total, 36 (74%) participants in the Stable group and 21 (60%) participants in the AECOPD group accepted the technology, but 10 participants (12%) expressed concerns with wearing a device around their chest. Conclusions: This wearable multiparametric technology showed good user acceptance and was able to measure vital signs in a COPD population. Data quality was generally high but was influenced by body composition. Overall, it was feasible to continuously measure vital signs during free-living conditions in people with COPD symptoms but with additional challenges in the post-AECOPD context. %M 35171101 %R 10.2196/30091 %U https://humanfactors.jmir.org/2022/1/e30091 %U https://doi.org/10.2196/30091 %U http://www.ncbi.nlm.nih.gov/pubmed/35171101 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e27487 %T Accuracy Assessment of Oura Ring Nocturnal Heart Rate and Heart Rate Variability in Comparison With Electrocardiography in Time and Frequency Domains: Comprehensive Analysis %A Cao,Rui %A Azimi,Iman %A Sarhaddi,Fatemeh %A Niela-Vilen,Hannakaisa %A Axelin,Anna %A Liljeberg,Pasi %A Rahmani,Amir M %+ Department of Electrical Engineering and Computer Science, University of California, 1407 Palo Verde Rd, Irvine, CA, 92617, United States, 1 6266883017, caor6@uci.edu %K electrocardiography %K ECG %K wearable device %K heart rate variability %K Oura smart ring %D 2022 %7 18.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Photoplethysmography is a noninvasive and low-cost method to remotely and continuously track vital signs. The Oura Ring is a compact photoplethysmography-based smart ring, which has recently drawn attention to remote health monitoring and wellness applications. The ring is used to acquire nocturnal heart rate (HR) and HR variability (HRV) parameters ubiquitously. However, these parameters are highly susceptible to motion artifacts and environmental noise. Therefore, a validity assessment of the parameters is required in everyday settings. Objective: This study aims to evaluate the accuracy of HR and time domain and frequency domain HRV parameters collected by the Oura Ring against a medical grade chest electrocardiogram monitor. Methods: We conducted overnight home-based monitoring using an Oura Ring and a Shimmer3 electrocardiogram device. The nocturnal HR and HRV parameters of 35 healthy individuals were collected and assessed. We evaluated the parameters within 2 tests, that is, values collected from 5-minute recordings (ie, short-term HRV analysis) and the average values per night sleep. A linear regression method, the Pearson correlation coefficient, and the Bland–Altman plot were used to compare the measurements of the 2 devices. Results: Our findings showed low mean biases of the HR and HRV parameters collected by the Oura Ring in both the 5-minute and average-per-night tests. In the 5-minute test, the error variances of the parameters were different. The parameters provided by the Oura Ring dashboard (ie, HR and root mean square of successive differences [RMSSD]) showed relatively low error variance compared with the HRV parameters extracted from the normal interbeat interval signals. The Pearson correlation coefficient tests (P<.001) indicated that HR, RMSSD, average of normal heart beat intervals (AVNN), and percentage of successive normal beat-to-beat intervals that differ by more than 50 ms (pNN50) had high positive correlations with the baseline values; SD of normal beat-to-beat intervals (SDNN) and high frequency (HF) had moderate positive correlations, and low frequency (LF) and LF:HF ratio had low positive correlations. The HR, RMSSD, AVNN, and pNN50 had narrow 95% CIs; however, SDNN, LF, HF, and LF:HF ratio had relatively wider 95% CIs. In contrast, the average-per-night test showed that the HR, RMSSD, SDNN, AVNN, pNN50, LF, and HF had high positive relationships (P<.001), and the LF:HF ratio had a moderate positive relationship (P<.001). The average-per-night test also indicated considerably lower error variances than the 5-minute test for the parameters. Conclusions: The Oura Ring could accurately measure nocturnal HR and RMSSD in both the 5-minute and average-per-night tests. It provided acceptable nocturnal AVNN, pNN50, HF, and SDNN accuracy in the average-per-night test but not in the 5-minute test. In contrast, the LF and LF:HF ratio of the ring had high error rates in both tests. %M 35040799 %R 10.2196/27487 %U https://www.jmir.org/2022/1/e27487 %U https://doi.org/10.2196/27487 %U http://www.ncbi.nlm.nih.gov/pubmed/35040799 %0 Journal Article %@ 2369-2529 %I JMIR Publications %V 8 %N 4 %P e29610 %T Adaptability of Assistive Mobility Devices and the Role of the Internet of Medical Things: Comprehensive Review %A Oladele,Daniel Ayo %A Markus,Elisha Didam %A Abu-Mahfouz,Adnan M %+ Department of Electrical, Electronic and Computer Engineering, Central University of Technology, 20 President Brand St, Bloemfontein Central, Bloemfontein, 9301, South Africa, 27 744062563, emarkus@cut.ac.za %K internet of medical things framework %K internet of things %K adaptability %K multisensor fusion %K mobility aids %K user system interface %K assistive mobility devices %K mobile phone %D 2021 %7 15.11.2021 %9 Review %J JMIR Rehabil Assist Technol %G English %X Background: With the projected upsurge in the percentage of people with some form of disability, there has been a significant increase in the need for assistive mobility devices. However, for mobility aids to be effective, such devices should be adapted to the user’s needs. This can be achieved by improving the confidence of the acquired information (interaction between the user, the environment, and the device) following design specifications. Therefore, there is a need for literature review on the adaptability of assistive mobility devices. Objective: In this study, we aim to review the adaptability of assistive mobility devices and the role of the internet of medical things in terms of the acquired information for assistive mobility devices. We review internet-enabled assistive mobility technologies and non–internet of things (IoT) assistive mobility devices. These technologies will provide awareness of the status of adaptive mobility technology and serve as a source and reference regarding information to health care professionals and researchers. Methods: We performed a literature review search on the following databases of academic references and journals: Google Scholar, ScienceDirect, Institute of Electrical and Electronics Engineers, Springer, and websites of assistive mobility and foundations presenting studies on assistive mobility found through a generic Google search (including the World Health Organization website). The following keywords were used: assistive mobility OR assistive robots, assistive mobility devices, internet-enabled assistive mobility technologies, IoT Framework OR IoT Architecture AND for Healthcare, assisted navigation OR autonomous navigation, mobility AND aids OR devices, adaptability of assistive technology, adaptive mobility devices, pattern recognition, autonomous navigational systems, human-robot interfaces, motor rehabilitation devices, perception, and ambient assisted living. Results: We identified 13,286 results (excluding titles that were not relevant to this study). Then, through a narrative review, we selected 189 potential studies (189/13,286, 1.42%) from the existing literature on the adaptability of assistive mobility devices and IoT frameworks for assistive mobility and conducted a critical analysis. Of the 189 potential studies, 82 (43.4%) were selected for analysis after meeting the inclusion criteria. On the basis of the type of technologies presented in the reviewed articles, we proposed a categorization of the adaptability of smart assistive mobility devices in terms of their interaction with the user (user system interface), perception techniques, and communication and sensing frameworks. Conclusions: We discussed notable limitations of the reviewed literature studies. The findings revealed that an improvement in the adaptation of assistive mobility systems would require a reduction in training time and avoidance of cognitive overload. Furthermore, sensor fusion and classification accuracy are critical for achieving real-world testing requirements. Finally, the trade-off between cost and performance should be considered in the commercialization of these devices. %M 34779786 %R 10.2196/29610 %U https://rehab.jmir.org/2021/4/e29610 %U https://doi.org/10.2196/29610 %U http://www.ncbi.nlm.nih.gov/pubmed/34779786 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 4 %P e30786 %T A Novel Digital Pill System for Medication Adherence Measurement and Reporting: Usability Validation Study %A Baumgartner,Susan L %A Buffkin Jr,D Eric %A Rukavina,Elise %A Jones,Jason %A Weiler,Elizabeth %A Carnes,Tony C %+ etectRx, Inc., 747 SW 2nd Avenue, Suite 365T, IMB 24, Gainesville, FL, 32601, United States, 1 678 602 5701, susan.baumgartner@etectrx.com %K digital pills %K digital medication %K ingestible event marker %K ingestible sensor %K human factors %K usability %K validation study %K medication adherence %K medication nonadherence %K remote patient monitoring %K mobile phone %D 2021 %7 8.11.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Medication nonadherence is a costly problem that is common in clinical use and clinical trials alike, with significant adverse consequences. Digital pill systems have proved to be effective and safe solutions to the challenges of nonadherence, with documented success in improving adherence and health outcomes. Objective: The aim of this human factors validation study is to evaluate a novel digital pill system, the ID-Cap System from etectRx, for usability among patient users in a simulated real-world use environment. Methods: A total of 17 patients with diverse backgrounds who regularly take oral prescription medications were recruited. After training and a period of training decay, the participants were asked to complete 12 patient-use scenarios during which errors or difficulties were logged. The participants were also interviewed about their experiences with the ID-Cap System. Results: The participants ranged in age from 27 to 74 years (mean 51 years, SD 13.8 years), and they were heterogeneous in other demographic factors as well, such as education level, handedness, and sex. In this human factors validation study, the patient users completed 97.5% (196/201) of the total use scenarios successfully; 75.1% (151/201) were completed without any failures or errors. The participants found the ID-Cap System easy to use, and they were able to accurately and proficiently record ingestion events using the device. Conclusions: The participants demonstrated the ability to safely and effectively use the ID-Cap System for its intended use. The ID-Cap System has great potential as a useful tool for encouraging medication adherence and can be easily implemented by patient users. %M 34747709 %R 10.2196/30786 %U https://humanfactors.jmir.org/2021/4/e30786 %U https://doi.org/10.2196/30786 %U http://www.ncbi.nlm.nih.gov/pubmed/34747709 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e31224 %T A Wi-Fi–Based Mask-Type Laryngoscope for Telediagnosis During the COVID-19 Pandemic: Instrument Validation Study %A Moon,Youngjin %A Hyun,Jaeho %A Oh,Jeongmin %A Lee,Kwanhee %A Lee,Yoon Se %A Kim,Jun Ki %+ Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-Gu, Seoul, Republic of Korea, 82 230108619, kim@amc.seoul.kr %K smartphone-based endoscope %K mobile health %K telediagnosis %K continuum segment %K articulable endoscope %K COVID-19 %K point-of-care diagnostics %K validation %K medical device %K endoscope %K sensor %K innovation %K video %K transmission %D 2021 %7 18.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Owing to the COVID-19 pandemic, social distancing has become mandatory. Wireless endoscopy in contactless examinations promises to protect health care workers and reduce viral spread. Objective: This study aimed to introduce a contactless endoscopic diagnosis system using a wireless endoscope resembling a mask. Methods: The Wi-Fi–based contactless mask endoscopy system comprises a disposable endoscope and a controller. First, the effective force applied by the tip during insertion was evaluated in a simple transoral model consisting of a force sensor on a simulated oropharynx wall. Second, the delay in video streaming was evaluated by comparing the frame rate and delays between a movement and its image over direct and Wi-Fi connections. Third, the system was applied to a detailed laryngopharyngeal tract phantom. Results: The smartphone-controlled wireless endoscopy system was successfully evaluated. The mean, maximum, and minimum collision forces against the wall of the transoral model were 296 mN (30 gf), 363 mN (37 gf), and 235 mN (24 gf), respectively. The delay resulting from the wireless connection was 0.72 seconds. Using the phantom, an inexperienced user took around 1 minute to orient the endoscope to a desired area via the app. Conclusions: Device articulation does not pose a significant risk of laryngopharyngeal wall penetration, and latency does not significantly impede its use. Contactless wireless video streaming was successful within the access point range regardless of the presence of walls. The mask endoscope can be controlled and articulated wirelessly, minimizing contact between patients and device operators. By minimizing contact, the device can protect health care workers from infectious viruses like the coronavirus. %M 34518154 %R 10.2196/31224 %U https://www.jmir.org/2021/10/e31224 %U https://doi.org/10.2196/31224 %U http://www.ncbi.nlm.nih.gov/pubmed/34518154 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 10 %P e33009 %T Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study %A Mathews,Simon C %A Templeton,Sandy %A Taylor,Stephanie K %A Harris,Sten %A Stewart,Margaret %A Raja,Shruti M %+ Johns Hopkins Medicine, 1800 Orleans St, Baltimore, MD, 21287, United States, 1 410 955 5000, smathe14@jhmi.edu %K digital health %K lactose intolerance %K digestive disease %K evaluation %K medical device %K detection %K diagnostic %K digestion %K testing %K performance %K gastrointestinal %K diagnosis %D 2021 %7 18.10.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Lactose malabsorption is a common condition that affects a broad segment of the population. Clinical diagnosis based on symptom recall can be unreliable and conventional testing can be inconvenient, requiring expensive laboratory-based equipment and conduction of the testing in a clinical setting. Objective: The aim of this study is to assess the performance of a digital handheld hydrogen breath monitor (GIMate) in diagnosing lactose malabsorption compared to a US Food and Drug Administration (FDA)–cleared device (H2 Check) for the same indication. Methods: An interventional crossover study was performed in adult participants with a prior confirmed diagnosis of lactose malabsorption or a suspected history of lactose intolerance. Results: A total of 31 participants (mean age 33.9 years) were enrolled in the study. There was 100% positive percent agreement and 100% negative percent agreement between the GIMate monitor and the H2 Check. Correlation between gastrointestinal symptoms and hydrogen values was positive at 0.82 (P<.001). Conclusions: The digital handheld GIMate breath monitor achieved equivalent diagnostic performance to that of an FDA-cleared device in the diagnosis of lactose malabsorption. Trial Registration: ClinicalTrials.gov NCT04754724; https://clinicaltrials.gov/ct2/show/NCT04754724 %M 34544034 %R 10.2196/33009 %U https://formative.jmir.org/2021/10/e33009 %U https://doi.org/10.2196/33009 %U http://www.ncbi.nlm.nih.gov/pubmed/34544034 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 3 %P e25356 %T Applying Mobile Technology to Sustain Physical Activity After Completion of Cardiac Rehabilitation: Acceptability Study %A Elnaggar,Abdelaziz %A von Oppenfeld,Julia %A Whooley,Mary A %A Merek,Stephanie %A Park,Linda G %+ Department of Community Health Systems, School of Nursing, University of California San Francisco, 2 Koret Way, Room 531A, San Francisco, CA, 94143-0610, United States, 1 415 502 6616, linda.park@ucsf.edu %K physical activity %K cardiac rehabilitation %K digital health %K mobile app %K wearable device, mHealth %K mobile phone %D 2021 %7 2.9.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Many patients do not meet the recommended levels of physical activity after completing a cardiac rehabilitation (CR) program. Wearable activity trackers and mobile phone apps are promising potential self-management tools for maintaining physical activity after CR completion. Objective: This study aims to evaluate the acceptability of a wearable device, mobile app, and push messages to facilitate physical activity following CR completion. Methods: We used semistructured interviews to assess the acceptability of various mobile technologies after participation in a pilot randomized controlled trial. Intervention patients in the randomized controlled trial wore the Fitbit Charge 2, used the Movn mobile app, and received push messages on cardiovascular disease prevention and physical activity for over 2 months. We asked 26 intervention group participants for feedback about their experience with the technology and conducted semistructured individual interviews with 7 representative participants. We used thematic analysis to create the main themes from individual interviews. Results: Our sample included participants with a mean age of 66.7 (SD 8.6) years; 23% (6/26) were female. Overall, there were varying levels of satisfaction with different technology components. There were 7 participants who completed the satisfaction questionnaires and participated in the interviews. The Fitbit and Movn mobile app received high satisfaction scores of 4.86 and 4.5, respectively, whereas push messages had a score of 3.14 out of 5. We identified four main themes through the interviews: technology use increased motivation to be physically active, technology use served as a reminder to be physically active, recommendations for technology to improve user experience, and desire for personal feedback. Conclusions: By applying a wearable activity tracker, mobile phone app, and push messages, our study showed strong potential for the adoption of new technologies by older adults to maintain physical activity after CR completion. Future research should include a larger sample over a longer period using a mixed methods approach to assess the efficacy of technology use for promoting long-term physical activity behavior in older adults. %M 34473064 %R 10.2196/25356 %U https://humanfactors.jmir.org/2021/3/e25356 %U https://doi.org/10.2196/25356 %U http://www.ncbi.nlm.nih.gov/pubmed/34473064 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 5 %N 2 %P e21186 %T User Perceptions and Experiences of a Handheld 12-Lead Electrocardiographic Device in a Clinical Setting: Usability Evaluation %A Wong,Kam Cheong %A Thiagalingam,Aravinda %A Kumar,Saurabh %A Marschner,Simone %A Kunwar,Ritu %A Bailey,Jannine %A Kok,Cindy %A Usherwood,Tim %A Chow,Clara K %+ Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Level 6, Block K, Entrance 10, Westmead Hospital, Hawkesbury Road, Westmead, 2145, Australia, 61 2 8890 3125, kam.wong@sydney.edu.au %K handheld %K electrocardiogram %K ECG %K acceptability %K usability %K user perception %K user experience %K atrial fibrillation %K long QT %K screening %D 2021 %7 26.8.2021 %9 Original Paper %J JMIR Cardio %G English %X Background: Cardiac arrhythmias are a leading cause of death. The mainstay method for diagnosing arrhythmias (eg, atrial fibrillation) and cardiac conduction disorders (eg, prolonged corrected QT interval [QTc]) is by using 12-lead electrocardiography (ECG). Handheld 12-lead ECG devices are emerging in the market. In tandem with emerging technology options, evaluations of device usability should go beyond validation of the device in a controlled laboratory setting and assess user perceptions and experiences, which are crucial for successful implementation in clinical practice. Objective: This study aimed to evaluate clinician and patient perceptions and experiences, regarding the usability of a handheld 12-lead ECG device compared to a conventional 12-lead ECG machine, and generalizability of this user-centered approach. Methods: International Organization for Standardization Guidelines on Usability and the Technology Acceptance Model were integrated to form the framework for this study, which was conducted in outpatient clinics and cardiology wards at Westmead Hospital, New South Wales, Australia. Each patient underwent 2 ECGs (1 by each device) in 2 postures (supine and standing) acquired in random sequence. The times taken by clinicians to acquire the first ECG (efficiency) using the devices were analyzed using linear regression. Electrocardiographic parameters (QT interval, QTc interval, heart rate, PR interval, QRS interval) and participant satisfaction surveys were collected. Device reliability was assessed by evaluating the mean difference of QTc measurements within ±15 ms, intraclass correlation coefficient, and level of agreement of the devices in detecting atrial fibrillation and prolonged QTc. Clinicians’ perceptions and feedback were assessed with semistructured interviews based on the Technology Acceptance Model. Results: A total of 100 patients (age: mean 57.9 years, SD 15.2; sex: male: n=64, female n=36) and 11 clinicians (experience acquiring ECGs daily or weekly 10/11, 91%) participated, and 783 ECGs were acquired. Mean differences in QTc measurements of both handheld and conventional devices were within ±15 ms with high intraclass correlation coefficients (range 0.90-0.96), and the devices had a good level of agreement in diagnosing atrial fibrillation and prolonged QTc (κ=0.68-0.93). Regardless of device, QTc measurements when patients were standing were longer duration than QTc measurements when patients were supine. Clinicians’ ECG acquisition times improved with usage (P<.001). Clinicians reported that device characteristics (small size, light weight, portability, and wireless ECG transmission) were highly desired features. Most clinicians agreed that the handheld device could be used for clinician-led mass screening with enhancement in efficiency by increasing user training. Regardless of device, patients reported that they felt comfortable when they were connected to the ECG devices. Conclusions: Reliability and usability of the handheld 12-lead ECG device were comparable to those of a conventional ECG machine. The user-centered evaluation approach helped us identify remediable action to improve the efficiency in using the device and identified highly desirable device features that could potentially help mass screening and remote assessment of patients. The approach could be applied to evaluate and better understand the acceptability and usability of new medical devices. %M 34435958 %R 10.2196/21186 %U https://cardio.jmir.org/2021/2/e21186 %U https://doi.org/10.2196/21186 %U http://www.ncbi.nlm.nih.gov/pubmed/34435958 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 9 %N 7 %P e24633 %T Digital Medical Device Companion (MyIUS) for New Users of Intrauterine Systems: App Development Study %A Karakoyun,Toeresin %A Podhaisky,Hans-Peter %A Frenz,Ann-Kathrin %A Schuhmann-Giampieri,Gabriele %A Ushikusa,Thais %A Schröder,Daniel %A Zvolanek,Michal %A Lopes Da Silva Filho,Agnaldo %+ eHealth and Medical Software Solutions, Bayer AG, eHealth & Medical Software Solutions, Building 0459, Wuppertal, 42096, Germany, 49 152 23914568, toeresin.karakoyun@bayer.com %K medical device %K levonorgestrel-releasing intrauterine system %K mobile medical app %K mobile phone %D 2021 %7 13.7.2021 %9 Original Paper %J JMIR Med Inform %G English %X Background: Women choosing a levonorgestrel-releasing intrauterine system may experience changes in their menstrual bleeding pattern during the first months following placement. Objective: Although health care professionals (HCPs) can provide counseling, no method of providing individualized information on the expected bleeding pattern or continued support is currently available for women experiencing postplacement bleeding changes. We aim to develop a mobile phone–based medical app (MyIUS) to meet this need and provide a digital companion to women after the placement of the intrauterine system. Methods: The MyIUS app is classified as a medical device and uses an artificial intelligence–based bleeding pattern prediction algorithm to estimate a woman’s future bleeding pattern in terms of intensity and regularity. We developed the app with the help of a multidisciplinary team by using a robust and high-quality design process in the context of a constantly evolving regulatory landscape. The development framework consisted of a phased approach including ideation, feasibility and concept finalization, product development, and product deployment or localization stages. Results: The MyIUS app was considered useful by HCPs and easy to use by women who were consulted during the development process. Following the launch of the sustainable app in selected pilot countries, performance metrics will be gathered to facilitate further technical and feature updates and enhancements. A real-world performance study will also be conducted to allow us to upgrade the app in accordance with the new European Commission Medical Device legislation and to validate the bleeding pattern prediction algorithm in a real-world setting. Conclusions: By providing a meaningful estimation of bleeding patterns and allowing an individualized approach to counseling and discussions about contraceptive method choice, the MyIUS app offers a useful tool that may benefit both women and HCPs. Further work is needed to validate the performance of the prediction algorithm and MyIUS app in a real-world setting. %M 34255688 %R 10.2196/24633 %U https://medinform.jmir.org/2021/7/e24633 %U https://doi.org/10.2196/24633 %U http://www.ncbi.nlm.nih.gov/pubmed/34255688 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 2 %P e28236 %T Research Trends in Artificial Intelligence Applications in Human Factors Health Care: Mapping Review %A Asan,Onur %A Choudhury,Avishek %+ School of Systems and Enterprises, Stevens Institute of Technology, 1 Castle Point Terrace, Hoboken, NJ, 07030, United States, 1 4145264330, oasan@stevens.edu %K artificial intelligence %K human factors %K health care systems %K ecological validity %K usability %K trust %K perception %K workload %D 2021 %7 18.6.2021 %9 Review %J JMIR Hum Factors %G English %X Background: Despite advancements in artificial intelligence (AI) to develop prediction and classification models, little research has been devoted to real-world translations with a user-centered design approach. AI development studies in the health care context have often ignored two critical factors of ecological validity and human cognition, creating challenges at the interface with clinicians and the clinical environment. Objective: The aim of this literature review was to investigate the contributions made by major human factors communities in health care AI applications. This review also discusses emerging research gaps, and provides future research directions to facilitate a safer and user-centered integration of AI into the clinical workflow. Methods: We performed an extensive mapping review to capture all relevant articles published within the last 10 years in the major human factors journals and conference proceedings listed in the “Human Factors and Ergonomics” category of the Scopus Master List. In each published volume, we searched for studies reporting qualitative or quantitative findings in the context of AI in health care. Studies are discussed based on the key principles such as evaluating workload, usability, trust in technology, perception, and user-centered design. Results: Forty-eight articles were included in the final review. Most of the studies emphasized user perception, the usability of AI-based devices or technologies, cognitive workload, and user’s trust in AI. The review revealed a nascent but growing body of literature focusing on augmenting health care AI; however, little effort has been made to ensure ecological validity with user-centered design approaches. Moreover, few studies (n=5 against clinical/baseline standards, n=5 against clinicians) compared their AI models against a standard measure. Conclusions: Human factors researchers should actively be part of efforts in AI design and implementation, as well as dynamic assessments of AI systems’ effects on interaction, workflow, and patient outcomes. An AI system is part of a greater sociotechnical system. Investigators with human factors and ergonomics expertise are essential when defining the dynamic interaction of AI within each element, process, and result of the work system. %M 34142968 %R 10.2196/28236 %U https://humanfactors.jmir.org/2021/2/e28236 %U https://doi.org/10.2196/28236 %U http://www.ncbi.nlm.nih.gov/pubmed/34142968 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 5 %N 1 %P e21055 %T Implantation of an Innovative Intracardiac Microcomputer System for Web-Based Real-Time Monitoring of Heart Failure: Usability and Patients’ Attitudes %A D´Ancona,Giuseppe %A Murero,Monica %A Feickert,Sebastian %A Kaplan,Hilmi %A Öner,Alper %A Ortak,Jasmin %A Ince,Hueseyin %+ Department of Cardiology, Vivantes Hospital Am Urban, Dieffenbachstraße 1, Berlin, 10967, Germany, 49 (030) 130 22 5, rgea@hotmail.com %K heart %K failure %K left atrial %K pressure %K intracardiac %K device %K monitoring %K implantable %K wireless %K transmission %K web-based %D 2021 %7 21.4.2021 %9 Original Paper %J JMIR Cardio %G English %X Background: Heart failure (HF) management guided by the measurement of intracardiac and pulmonary pressure values obtained through innovative permanent intracardiac microsensors has been recently proposed as a valid strategy to individualize treatment and anticipate hemodynamic destabilization. These sensors have potential to reduce patient hospitalization rates and optimize quality of life. Objective: The aim of this study was to evaluate the usability and patients’ attitudes toward a new permanent intracardiac device implanted to remotely monitor left intra-atrial pressures (V-LAP, Vectorious Medical Technologies, Tel Aviv, Israel) in patients with chronic HF. Methods: The V-LAP system is a miniaturized sensor implanted percutaneously across the interatrial septum. The system communicates wirelessly with a “companion device” (a wearable belt) that is placed on the patient’s chest at the time of acquisition/transmission of left heart pressure measurements. At first follow-up after implantation, the patients and health care providers were asked to fill out a questionnaire on the usability of the system, ease in performing the various required tasks (data acquisition and transmission), and overall satisfaction. Replies to the questions were mainly given using a 5-point Likert scale (1: very poor, 2: poor, 3: average, 4: good, 5: excellent). Further patient follow-ups were performed at 3, 6, and 12 months. Results: Use and acceptance of the first 14 patients receiving the V-LAP technology worldwide and related health care providers have been analyzed to date. No periprocedural morbidity/mortality was observed. Before discharge, a tailored educational session was performed after device implantation with the patients and their health care providers. At the first follow-up, the mean score for overall comfort in technology use was 3.7 (SD 1.2) with 93% (13/14) of patients succeeding in applying and operating the system independently. For health care providers, the mean score for overall ease and comfort in use of the technology was 4.2 (SD 0.8). No significant differences were found between the patients’ and health care providers’ replies to the questionnaires. There was a general trend for higher scores in patients’ usability reports at later follow-ups, in which the score related to overall comfort with using the technology increased from 3.0 (SD 1.4) to 4.0 (SD 0.7) (P=.40) and comfort with wearing and adjusting the measuring thoracic belt increased from 2.8 (SD 1.0) to 4.2 (SD 0.4) (P=.02). Conclusions: Despite the gravity of their HF pathology and the complexity of their comorbid profile, patients are comfortable in using the V-LAP technology and, in the majority of cases, they can correctly and consistently acquire and transmit hemodynamic data. Although the overall patient/care provider satisfaction with the V-LAP system seems to be acceptable, improvements can be achieved after ameliorating the design of the measuring tools. Trial Registration: ClincalTrials.gov NCT03775161; https://clinicaltrials.gov/ct2/show/NCT03775161 %M 33881400 %R 10.2196/21055 %U https://cardio.jmir.org/2021/1/e21055 %U https://doi.org/10.2196/21055 %U http://www.ncbi.nlm.nih.gov/pubmed/33881400 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 4 %P e24142 %T Twelve-Lead Electrocardiogram Acquisition With a Patchy-Type Wireless Device in Ambulance Transport: Simulation-Based Randomized Controlled Trial %A Yoon,Sunyoung %A Kim,Taerim %A Roh,Taehwan %A Chang,Hansol %A Hwang,Sung Yeon %A Yoon,Hee %A Shin,Tae Gun %A Sim,Min Seob %A Jo,Ik Joon %A Cha,Won Chul %+ Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea, 82 2 3410 2053, docchaster@gmail.com %K 12-lead electrocardiogram %K electrocardiogram transmission %K prehospital %K wearable patch device %K wearable %K electrocardiogram %K ECG %K cardiovascular %K efficiency %K feasibility %K EMT %D 2021 %7 1.4.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Cardiovascular disease is the leading cause of death worldwide. Early recognition, diagnosis, and reperfusion are the key elements of treatment for ST-segment elevation myocardial infarction. The absence of a prehospital 12-lead electrocardiogram (P12ECG) can cause definitive treatment delay and repeated transfer. Although guidelines highly recommend the measurement and transmission of P12ECG data, P12ECG use has not been widely established. Objective: The aim of this study was to verify the time-efficiency and feasibility of the use of a patchy-type 12-lead ECG measuring and transmitting device (P-ECG) by an emergency medical technician (EMT) in an ambulance during patient transport. Methods: This was a simulation-based prospective randomized crossover-controlled study that included EMTs. The participants were randomly assigned to one of two groups. Group A began the experiment with a conventional 12-lead ECG (C-ECG) device and then switched to the intervention device (P-ECG), whereas group B began the experiment with the P-ECG and then switched to the C-ECG. All simulations were performed inside an ambulance driving at 30 km/h. The time interval was measured from the beginning of ECG application to completion of sending the results. After the simulation, participants were administered the System Usability Scale questionnaire about usability of the P-ECG. Results: A total of 18 EMTs were recruited for this study with a median age of 35 years. The overall interval time for the C-ECG was 254 seconds (IQR 247-270), whereas the overall interval time for the P-ECG was 130 seconds (IQR 112-150), with a significant difference (P<.001). Significant differences between the C-ECG and P-ECG were identified at all time intervals, in which the P-ECG device was significantly faster in all intervals, except for the preparation interval in which the C-ECG was faster (P=.03). Conclusions: Performance of 12-lead ECG examination and transmission of the results using P-ECG are faster than those of C-ECG during ambulance transport. With the additional time afforded, EMTs can provide more care to patients and transport patients more rapidly, which may help reduce the symptoms-to-balloon time for patients with acute coronary syndrome. Trial Registration: ClinicalTrials.gov NCT04114760; https://www.clinicaltrials.gov/ct2/show/NCT04114760 %M 33792550 %R 10.2196/24142 %U https://mhealth.jmir.org/2021/4/e24142 %U https://doi.org/10.2196/24142 %U http://www.ncbi.nlm.nih.gov/pubmed/33792550 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 3 %P e25406 %T Digital Health Integration Assessment and Maturity of the United States Biopharmaceutical Industry: Forces Driving the Next Generation of Connected Autoinjectable Devices %A Rafiei,Ramin %A Williams,Chelsea %A Jiang,Jeannette %A Aungst,Timothy Dy %A Durrer,Matthias %A Tran,Dao %A Howald,Ralph %+ SHL Medical, Gubelstrasse 22, 6300, Zug, Switzerland, 1 5617135654, chelsea.williams@shl-medical.com %K digital health %K artificial intelligence %K drug delivery %K biopharma %K autoinjector %K injectable devices %K disease management %K autoimmune %K oncology %K rare diseases %D 2021 %7 18.3.2021 %9 Viewpoint %J JMIR Mhealth Uhealth %G English %X Autoinjectable devices continue to provide real-life benefits for patients with chronic conditions since their widespread adoption 30 years ago with the rise of macromolecules. Nonetheless, issues surrounding adherence, patient administration techniques, disease self-management, and data outcomes at scale persist despite product design innovation. The interface of drug device combination products and digital health technologies formulates a value proposition for next-generation autoinjectable devices to power the delivery of precision care at home and achieve the full potential of biologics. Success will largely be dependent on biopharma’s digital health maturity to implement this framework. This viewpoint measures the digital health maturity of the top 15 biopharmaceutical companies in the US biologics autoinjector market and establishes the framework for next-generation autoinjectable devices powering home-based precision care and the need for formal digital health training. %M 33621188 %R 10.2196/25406 %U https://mhealth.jmir.org/2021/3/e25406 %U https://doi.org/10.2196/25406 %U http://www.ncbi.nlm.nih.gov/pubmed/33621188 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 1 %P e24846 %T Effects of User Characteristics on the Usability of a Home-Connected Medical Device (Smart Angel) for Ambulatory Monitoring: Usability Study %A Chaniaud,Noémie %A Megalakaki,Olga %A Capo,Sophie %A Loup-Escande,Emilie %+ Centre de Recherche en Psychologie: Cognition, Psychisme et Organisations, Université de Picardie Jules Verne, Chemin du Thil, Amiens, UR UPJV 7273, France, 33 3 22 82 70 59, noemie.chaniaud@u-picardie.fr %K user characteristics %K health literacy %K home medical devices %K usability study %K remote health %K home health %D 2021 %7 17.3.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: The Smart Angel home medical device allows ambulatory surgery patients to monitor their own health by taking their blood pressure and oxygen levels and answering a health questionnaire from home. Currently, this device is a prototype in the design phase, and no usability evaluation has been performed. This preventive device must be usable by patients with different profiles; however, it is important to select patients carefully to ensure their safety when using the device. As such, it would be interesting to know how to select or exclude patients. However, the links between user characteristics and the usability of this home medical device remain unclear. Objective: This study aims to better understand the links between certain characteristics of potential patients (ie, age, education, technophilia, and health literacy) and the usability (ie, effectiveness, efficiency, and satisfaction) of Smart Angel, as defined by the ISO 9241-11. Methods: We conducted an experimental study involving 36 participants investigating the effects of 4 patient characteristics (ie, age, education, technophilia, and health literacy) on usability, measured in terms of effectiveness, efficiency, and satisfaction. A mixed methods approach (subjective vs objective) using a variety of standard instruments was adopted (direct observation, video analysis, and questionnaires). First, to help participants project themselves into the real use of the Smart Angel device, they watched a scenario in a video. Second, the participants completed a set of questionnaires to show the extent of their health literacy level (Newest Vital Sign [NVS] and the Health Literacy Survey [HLS]) and then operated Smart Angel devices. Efficiency (ie, handling time) and effectiveness (ie, number of handling errors) measures were collected by video analysis. Satisfaction measures were collected by a questionnaire (System Usability Scale [SUS]). The qualitative observational data were coded using inductive analysis by 2 independent researchers specialized in cognitive psychology and cognitive ergonomics. Results: The results show a moderate and positive correlation between age and effectiveness (r=0.359; P=.03) and efficiency (r=0.357; P=.03). There is strong correlation between health literacy scored by the NVS and effectiveness (r=0.417; P=.01), efficiency (r=-0.38; P=.02), and satisfaction (r=0.45; P=.006). However, there is a weak correlation between technophilia and usability and no relationship between education level and usability. Conclusions: Our results show that literacy level and age are 2 important factors to consider when selecting future users of the Smart Angel device to ensure patient safety. This study also serves as an example promoting mixed methodologies in assessments of medical device usability that cannot be performed under real-world conditions. %M 33729161 %R 10.2196/24846 %U https://humanfactors.jmir.org/2021/1/e24846 %U https://doi.org/10.2196/24846 %U http://www.ncbi.nlm.nih.gov/pubmed/33729161 %0 Journal Article %@ 2562-7600 %I JMIR Publications %V 4 %N 1 %P e20584 %T Improving the Safety, Effectiveness, and Efficiency of Clinical Alarm Systems: Simulation-Based Usability Testing of Physiologic Monitors %A Sowan,Azizeh K %A Staggers,Nancy %A Berndt,Andrea %A Austin,Tommye %A Reed,Charles C %A Malshe,Ashwin %A Kilger,Max %A Fonseca,Elma %A Vera,Ana %A Chen,Qian %+ School of Nursing, University of Texas Health at San Antonio, 7703 Floyd Curl Dr - MC 7975, San Antonio, TX, 78229-3900, United States, 1 210 567 5799, Sowan@uthscsa.edu %K usability testing %K clinical alarms %K fatigue %K critical care %K patient safety %K nursing %D 2021 %7 3.2.2021 %9 Original Paper %J JMIR Nursing %G English %X Background: Clinical alarm system safety is a national patient safety goal in the United States. Physiologic monitors are associated with the highest number of device alarms and alarm-related deaths. However, research involving nurses’ use of physiologic monitors is rare. Hence, the identification of critical usability issues for monitors, especially those related to patient safety, is a nursing imperative. Objective: This study examined nurses’ usability of physiologic monitors in intensive care units with respect to the effectiveness and efficiency of monitor use. Methods: In total, 30 nurses from 4 adult intensive care units completed 40 tasks in a simulation environment. The tasks were common monitoring tasks that were crucial for appropriate monitoring and safe alarm management across four categories of competencies: admitting, transferring, and discharging patients using the monitors (7 tasks); managing measurements and monitor settings (23 tasks); performing electrocardiogram (ECG) analysis (7 tasks); and troubleshooting alarm conditions (3 tasks). The nurse-monitor interaction was video-recorded. The principal investigator and two expert intensive care units nurse educators identified, classified, and validated task success (effectiveness) and the time of task completion (efficiency). Results: Among the 40 tasks, only 2 (5%) were successfully completed by all the nurses. At least 1-27 (3%-90%) nurses abandoned or did not correctly perform 38 tasks. The task with the shortest completion time was “take monitor out of standby” (mean 0:02, SD 0:01 min:s), whereas the task “record a 25 mm/s ECG strip of any of the ECG leads” had the longest completion time (mean 1:14, SD 0:32 min:s). The total time to complete 37 navigation-related tasks ranged from a minimum of 3 min 57 s to a maximum of 32 min 42 s. Regression analysis showed that it took 6 s per click or step to successfully complete a task. To understand the nurses’ thought processes during monitor navigation, the authors analyzed the paths of the 2 tasks with the lowest successful completion rates, where only 13% (4/30) of the nurses correctly completed these 2 tasks. Although 30% (9/30) of the nurses accessed the correct screen first for task 1 and task 2, they could not find their way easily from there to successfully complete the 2 tasks. Conclusions: Usability testing of physiologic monitors revealed major ineffectiveness and inefficiencies in the current nurse-monitor interactions. The results indicate the potential for safety and productivity issues in completing routine tasks. Training on monitor use should include critical monitoring functions that are necessary for safe, effective, efficient, and appropriate monitoring to include knowledge of the shortest navigation path. It is imperative that vendors’ future monitor designs mimic clinicians’ thought processes for successful, safe, and efficient monitor navigation. %M 34345793 %R 10.2196/20584 %U https://nursing.jmir.org/2021/1/e20584/ %U https://doi.org/10.2196/20584 %U http://www.ncbi.nlm.nih.gov/pubmed/34345793 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e17436 %T Effects of the Argus II Retinal Prosthesis System on the Quality of Life of Patients With Ultra-Low Vision Due to Retinitis Pigmentosa: Protocol for a Single-Arm, Mixed Methods Study %A White,Judith %A Knight,Laura %A da Cruz,Lyndon %A Stanga,Paulo E %A Patrick,Hannah %A Powell,Helen %A Berry,Lee %A Withers,Kathleen %A Carolan-Rees,Grace %A Jackson,Timothy L %+ Cedar, Cardiff & Vale University Health Board, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, United Kingdom, 44 02920744771, judith.white3@wales.nhs.uk %K patient-reported outcomes %K quality of life %K qualitative methods %K artificial vision %K visual function %K functional vision %K ultra-low vision %K low vision %K visual function questionnaire %D 2021 %7 20.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients’ quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England’s Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. Objective: The aim of this study was to assess the effect of the Argus II device on patient’s daily activities and quality of life. Methods: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users’ experiences with the procedure, the device, and rehabilitation. The effect of the device on patients’ functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. Results: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. Conclusions: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants’ quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work. International Registered Report Identifier (IRRID): PRR1-10.2196/17436 %M 33470946 %R 10.2196/17436 %U http://www.researchprotocols.org/2021/1/e17436/ %U https://doi.org/10.2196/17436 %U http://www.ncbi.nlm.nih.gov/pubmed/33470946 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 9 %N 1 %P e22753 %T A Low-Cost, Ear-Contactless Electronic Stethoscope Powered by Raspberry Pi for Auscultation of Patients With COVID-19: Prototype Development and Feasibility Study %A Yang,Chuan %A Zhang,Wei %A Pang,Zhixuan %A Zhang,Jing %A Zou,Deling %A Zhang,Xinzhong %A Guo,Sicong %A Wan,Jiye %A Wang,Ke %A Pang,Wenyue %+ Department of Cardiology, Shengjing Hospital of China Medical University, 36 Sanhao Street, Shenyang, 110004, China, 86 18940258063, pangwy@sj-hospital.org %K stethoscope %K auscultation %K COVID-19 %K Raspberry Pi %K Python %K ear-contactless %K low-cost %K phonocardiogram %K digital health %D 2021 %7 19.1.2021 %9 Original Paper %J JMIR Med Inform %G English %X Background: Chest examination by auscultation is essential in patients with COVID-19, especially those with poor respiratory conditions, such as severe pneumonia and respiratory dysfunction, and intensive cases who are intubated and whose breathing is assisted with a ventilator. However, proper auscultation of these patients is difficult when medical workers wear personal protective equipment and when it is necessary to minimize contact with patients. Objective: The objective of our study was to design and develop a low-cost electronic stethoscope enabling ear-contactless auscultation and digital storage of data for further analysis. The clinical feasibility of our device was assessed in comparison to a standard electronic stethoscope. Methods: We developed a prototype of the ear-contactless electronic stethoscope, called Auscul Pi, powered by Raspberry Pi and Python. Our device enables real-time capture of auscultation sounds with a microspeaker instead of an earpiece, and it can store data files for later analysis. We assessed the feasibility of using this stethoscope by detecting abnormal heart and respiratory sounds from 8 patients with heart failure or structural heart diseases and from 2 healthy volunteers and by comparing the results with those from a 3M Littmann electronic stethoscope. Results: We were able to conveniently operate Auscul Pi and precisely record the patients’ auscultation sounds. Auscul Pi showed similar real-time recording and playback performance to the Littmann stethoscope. The phonocardiograms of data obtained with the two stethoscopes were consistent and could be aligned with the cardiac cycles of the corresponding electrocardiograms. Pearson correlation analysis of amplitude data from the two types of phonocardiograms showed that Auscul Pi was correlated with the Littmann stethoscope with coefficients of 0.3245-0.5570 for healthy participants (P<.001) and of 0.3449-0.5138 among 4 patients (P<.001). Conclusions: Auscul Pi can be used for auscultation in clinical practice by applying real-time ear-contactless playback followed by quantitative analysis. Auscul Pi may allow accurate auscultation when medical workers are wearing protective suits and have difficulties in examining patients with COVID-19. Trial Registration: ChiCTR.org.cn ChiCTR2000033830; http://www.chictr.org.cn/showproj.aspx?proj=54971. %M 33436354 %R 10.2196/22753 %U https://medinform.jmir.org/2021/1/e22753 %U https://doi.org/10.2196/22753 %U http://www.ncbi.nlm.nih.gov/pubmed/33436354 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 4 %N 1 %P e20633 %T A Novel Virtual Reality Medical Image Display System for Group Discussions of Congenital Heart Disease: Development and Usability Testing %A Kim,Byeol %A Loke,Yue-Hin %A Mass,Paige %A Irwin,Matthew R %A Capeland,Conrad %A Olivieri,Laura %A Krieger,Axel %+ University of Maryland, 2181 Glenn L Martin Hall, University of Maryland, College Park, MD, 20742, United States, 1 516 428 3217, star@umd.edu %K virtual reality %K cardiac diagnostics %K usability study %K congenital heart disease %K group collaboration %D 2020 %7 8.12.2020 %9 Original Paper %J JMIR Cardio %G English %X Background: The complex 3-dimensional (3D) nature of anatomical abnormalities in congenital heart disease (CHD) necessitates multidisciplinary group discussions centered around the review of medical images such as magnetic resonance imaging. Currently, group viewings of medical images are constrained to 2-dimensional (2D) cross-sectional displays of 3D scans. However, 2D display methods could introduce additional challenges since they require physicians to accurately reconstruct the images mentally into 3D anatomies for diagnosis, staging, and planning of surgery or other therapies. Virtual reality (VR) software may enhance diagnosis and care of CHD via 3D visualization of medical images. Yet, present-day VR developments for medicine lack the emphasis on multiuser collaborative environments, and the effect of displays and level of immersion for diagnosing CHDs have not been studied. Objective: The objective of the study was to evaluate and compare the diagnostic accuracies and preferences of various display systems, including the conventional 2D display and a novel group VR software, in group discussions of CHD. Methods: A total of 22 medical trainees consisting of 1 first-year, 10 second-year, 4 third-year, and 1 fourth-year residents and 6 medical students, who volunteered for the study, were formed into groups of 4 to 5 participants. Each group discussed three diagnostic cases of CHD with varying structural complexity using conventional 2D display and group VR software. A group VR software, Cardiac Review 3D, was developed by our team using the Unity engine. By using different display hardware, VR was classified into nonimmersive and full-immersive settings. The discussion time, diagnostic accuracy score, and peer assessment were collected to capture the group and individual diagnostic performances. The diagnostic accuracies for each participant were scored by two experienced cardiologists following a predetermined answer rubric. At the end of the study, all participants were provided a survey to rank their preferences of the display systems for performing group medical discussions. Results: Diagnostic accuracies were highest when groups used the full-immersive VR compared with the conventional and nonimmersive VR (χ22=9.0, P=.01) displays. Differences between the display systems were more prominent with increasing case complexity (χ22=14.1, P<.001) where full-immersive VR had accuracy scores that were 54.49% and 146.82% higher than conventional and nonimmersive VR, respectively. The diagnostic accuracies provided by the two cardiologists for each participant did not statistically differ from each other (t=–1.01, P=.31). The full-immersive VR was ranked as the most preferred display for performing group CHD discussions by 68% of the participants. Conclusions: The most preferred display system among medical trainees for visualizing medical images during group diagnostic discussions is full-immersive VR, with a trend toward improved diagnostic accuracy in complex anatomical abnormalities. Immersion is a crucial feature of displays of medical images for diagnostic accuracy in collaborative discussions. %M 33289675 %R 10.2196/20633 %U http://cardio.jmir.org/2020/1/e20633/ %U https://doi.org/10.2196/20633 %U http://www.ncbi.nlm.nih.gov/pubmed/33289675 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 9 %P e17983 %T Effect of Prior Health Knowledge on the Usability of Two Home Medical Devices: Usability Study %A Chaniaud,Noémie %A Métayer,Natacha %A Megalakaki,Olga %A Loup-Escande,Emilie %+ Centre de Rercherche en Psychologie: Cognition Psychisme et Organisations, Université Picardie Jules Verne, Pôle Campus Sud - Bâtiment E - 3ème étage 1, Chemin du Thil - CS 52 501, Amiens, 80 025 CEDEX 1, France, 33 3 22 82 70 59, noemie.chaniaud@u-picardie.fr %K usability %K prior health knowledge %K mHealth %K home medical devices %K blood pressure monitor %K pulse oximeter %D 2020 %7 21.9.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Studies on the usability of health care devices are becoming more common, although usability standards are not necessarily specified and followed. Yet, there is little knowledge about the impact of the context of use on the usability outcome. It is specified in the usability standard (ISO 9241-11, 2018) of a device that it may be affected by its context of use and especially by the characteristics of its users. Among these, prior health knowledge (ie, knowledge about human body functioning) is crucial. However, no study has shown that prior health knowledge influences the usability of medical devices.  Objective: Our study aimed to fill this gap by analyzing the relationship between the usability of two home medical devices (soon to be used in the context of ambulatory surgery) and prior health knowledge through an experimental approach. Methods: For assessing the usability of two home medical devices (blood pressure monitor and pulse oximeter), user tests were conducted among 149 students. A mixed-methods approach (subjective vs objective) using a variety of standard instruments was adopted (direct observation, video analysis, and questionnaires). Participants completed a questionnaire to show the extent of their previous health knowledge and then operated both devices randomly. Efficiency (ie, handling time) and effectiveness (ie, number of handling errors) measures were collected by video analysis. Satisfaction measures were collected by a questionnaire (system usability scale [SUS]). The qualitative observational data were coded using inductive analysis by two independent researchers specialized in cognitive psychology and cognitive ergonomics. Correlational analyses and clusters were performed to test how usability relates to sociodemographic characteristics and prior health knowledge. Results: The results indicated a lack of usability for both devices. Regarding the blood pressure monitor (137 participants), users made approximately 0.77 errors (SD 1.49), and the mean SUS score was 72.4 (SD 21.07), which is considered “satisfactory.” The pulse oximeter (147 participants) appeared easier to use, but participants made more errors (mean 0.99, SD 0.92), and the mean SUS score was 71.52 (SD 17.29), which is considered “satisfactory.” The results showed a low negative and significant correlation only between the effectiveness of the two devices and previous knowledge (blood pressure monitor: r=−0.191, P=.03; pulse oximeter: r=−0.263, P=.001). More subtly, we experimentally identified the existence of a threshold level (χ²2,146=10.9, P=.004) for health knowledge to correctly use the pulse oximeter, but this was missing for the blood pressure monitor. Conclusions: This study has the following two contributions: (1) a theoretical interest highlighting the importance of user characteristics including prior health knowledge on usability outcomes and (2) an applied interest to provide recommendations to designers and medical staff. %M 32955454 %R 10.2196/17983 %U http://mhealth.jmir.org/2020/9/e17983/ %U https://doi.org/10.2196/17983 %U http://www.ncbi.nlm.nih.gov/pubmed/32955454 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 7 %N 3 %P e17416 %T Embedding the Pillars of Quality in Health Information Technology Solutions Using “Integrated Patient Journey Mapping” (IPJM): Case Study %A McCarthy,Stephen %A O'Raghallaigh,Paidi %A Woodworth,Simon %A Lim,Yoke Yin %A Kenny,Louise C %A Adam,Frédéric %+ Department of Business Information Systems, Cork University Business School, University College Cork, Western Road, Cork, T12 K8AF, Ireland, 353 21 490 ext 3214, stephen.mccarthy@ucc.ie %K health information technology %K health care quality %K data analytics %K multidisciplinary research %K mobile phone %D 2020 %7 17.9.2020 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Health information technology (HIT) and associated data analytics offer significant opportunities for tackling some of the more complex challenges currently facing the health care sector. However, to deliver robust health care service improvements, it is essential that HIT solutions be designed by parallelly considering the 3 core pillars of health care quality: clinical effectiveness, patient safety, and patient experience. This requires multidisciplinary teams to design interventions that both adhere to medical protocols and achieve the tripartite goals of effectiveness, safety, and experience. Objective: In this paper, we present a design tool called Integrated Patient Journey Mapping (IPJM) that was developed to assist multidisciplinary teams in designing effective HIT solutions to address the 3 core pillars of health care quality. IPJM is intended to support the analysis of requirements as well as to promote empathy and the emergence of shared commitment and understanding among multidisciplinary teams. Methods: A 6-month, in-depth case study was conducted to derive findings on the use of IPJM during Learning to Evaluate Blood Pressure at Home (LEANBH), a connected health project that developed an HIT solution for the perinatal health context. Data were collected from over 700 hours of participant observations and 10 semistructured interviews. Results: The findings indicate that IPJM offered a constructive tool for multidisciplinary teams to work together in designing an HIT solution, through mapping the physical and emotional journey of patients for both the current service and the proposed connected health service. This allowed team members to consider the goals, tasks, constraints, and actors involved in the delivery of this journey and to capture requirements for the digital touchpoints of the connected health service. Conclusions: Overall, IPJM facilitates the design and implementation of complex HITs that require multidisciplinary participation. %M 32940610 %R 10.2196/17416 %U http://humanfactors.jmir.org/2020/3/e17416/ %U https://doi.org/10.2196/17416 %U http://www.ncbi.nlm.nih.gov/pubmed/32940610 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 9 %P e17057 %T Cost-Effective Smartphone-Based Articulable Endoscope Systems for Developing Countries: Instrument Validation Study %A Moon,Youngjin %A Oh,Jeongmin %A Hyun,Jaeho %A Kim,Youngkyu %A Choi,Jaesoon %A Namgoong,Jeongman %A Kim,Jun Ki %+ Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-Gu, Seoul, , Republic of Korea, 82 23 010 8619, kim@amc.seoul.kr %K smartphone-based endoscope %K mobile health %K low-resource settings %K continuum body %K articulable endoscope %K low-cost medical device %K point of care diagnostics %D 2020 %7 10.9.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Endoscopes are widely used for visualizing the respiratory tract, urinary tract, uterus, and gastrointestinal tracts. Despite high demand, people in underdeveloped and developing countries cannot obtain proper access to endoscopy. Moreover, commercially available endoscopes are mostly nonarticulable as well as not actively controlled, limiting their use. Articulating endoscopes are required for some diagnosis procedures, due to their ability to image wide areas of internal organs. Furthermore, actively controlled articulating endoscopes are less likely to harm the lumen than rigid endoscopes because they can avoid contact with endothelial tissues. Objective: The study aimed to demonstrate the feasibility and acceptability of smartphone-based wide-field articulable endoscope system for minimally invasive clinical applications in developing and less developed countries. Methods: A thin articulable endoscope system that can be attached to and actively controlled by a smartphone was designed and constructed. The system consists of a flexible endoscopic probe with a continuum mechanism, 4 motor modules for articulation, a microprocessor for controlling the motor with a smartphone, and a homebuilt app for streaming, capturing, adjusting images and video, and controlling the motor module with a joystick-like user interface. The smartphone and motor module are connected via an integrated C-type On-The-Go (OTG) USB hub. Results: We tested the device in several human-organ phantoms to evaluate the usability and utility of the smartphone-based articulating endoscope system. The resolution (960 × 720 pixels) of the device was found to be acceptable for medical diagnosis. The maximum bending angle of 110° was designed. The distance from the base of the articulating module to the tip of the endoscope was 45 mm. The angle of the virtual arc was 40.0°, for a curvature of 0.013. The finest articulation resolution was 8.9°. The articulating module succeeded in imaging all 8 octants of a spherical target, as well as all 4 quadrants of the indices marked in human phantoms. Conclusions: The portable wide-field endoscope was successfully controlled using a smartphone, yielding clear images with a resolution of 960 × 720 pixels at realistic focal distances. Actively and precisely controlled articulating movements have resulted in minimally invasive monitoring in the narrow space of internal organs providing a wide-area view. We found our smartphone-based active articulated endoscope to be suitable for point-of-care applications in developing and less developed countries. %M 32909951 %R 10.2196/17057 %U http://mhealth.jmir.org/2020/9/e17057/ %U https://doi.org/10.2196/17057 %U http://www.ncbi.nlm.nih.gov/pubmed/32909951 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e19472 %T Validation of the Raw National Aeronautics and Space Administration Task Load Index (NASA-TLX) Questionnaire to Assess Perceived Workload in Patient Monitoring Tasks: Pooled Analysis Study Using Mixed Models %A Said,Sadiq %A Gozdzik,Malgorzata %A Roche,Tadzio Raoul %A Braun,Julia %A Rössler,Julian %A Kaserer,Alexander %A Spahn,Donat R %A Nöthiger,Christoph B %A Tscholl,David Werner %+ Department of Anesthesiology, University Hospital Zurich, Raemistrasse 100, Zurich, 8091, Switzerland, 41 786718911, sadiq.said@usz.ch %K workload %K questionnaires %K National Aeronautics and Space Administration Task Load Index %K awareness %K situation awareness %K patient monitoring %K thromboelastometry %D 2020 %7 7.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Patient monitoring is indispensable in any operating room to follow the patient’s current health state based on measured physiological parameters. Reducing workload helps to free cognitive resources and thus influences human performance, which ultimately improves the quality of care. Among the many methods available to assess perceived workload, the National Aeronautics and Space Administration Task Load Index (NASA-TLX) provides the most widely accepted tool. However, only few studies have investigated the validity of the NASA-TLX in the health care sector. Objective: This study aimed to validate a modified version of the raw NASA-TLX in patient monitoring tasks by investigating its correspondence with expected lower and higher workload situations and its robustness against nonworkload-related covariates. This defines criterion validity. Methods: In this pooled analysis, we evaluated raw NASA-TLX scores collected after performing patient monitoring tasks in four different investigator-initiated, computer-based, prospective, multicenter studies. All of them were conducted in three hospitals with a high standard of care in central Europe. In these already published studies, we compared conventional patient monitoring with two newly developed situation awareness–oriented monitoring technologies called Visual Patient and Visual Clot. The participants were resident and staff anesthesia and intensive care physicians, and nurse anesthetists with completed specialization qualification. We analyzed the raw NASA-TLX scores by fitting mixed linear regression models and univariate models with different covariates. Results: We assessed a total of 1160 raw NASA-TLX questionnaires after performing specific patient monitoring tasks. Good test performance and higher self-rated diagnostic confidence correlated significantly with lower raw NASA-TLX scores and the subscores (all P<.001). Staff physicians rated significantly lower workload scores than residents (P=.001), whereas nurse anesthetists did not show any difference in the same comparison (P=.83). Standardized distraction resulted in higher rated total raw NASA-TLX scores (P<.001) and subscores. There was no gender difference regarding perceived workload (P=.26). The new visualization technologies Visual Patient and Visual Clot resulted in significantly lower total raw NASA-TLX scores and all subscores, including high self-rated performance, when compared with conventional monitoring (all P<.001). Conclusions: This study validated a modified raw NASA-TLX questionnaire for patient monitoring tasks. The scores obtained correctly represented the assumed influences of the examined covariates on the perceived workload. We reported high criterion validity. The NASA-TLX questionnaire appears to be a reliable tool for measuring subjective workload. Further research should focus on its applicability in a clinical setting. %M 32780712 %R 10.2196/19472 %U http://www.jmir.org/2020/9/e19472/ %U https://doi.org/10.2196/19472 %U http://www.ncbi.nlm.nih.gov/pubmed/32780712 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e18570 %T DenTiUS Plaque, a Web-Based Application for the Quantification of Bacterial Plaque: Development and Usability Study %A Vila-Blanco,Nicolás %A Freire,Vicente %A Balsa-Castro,Carlos %A Tomás,Inmaculada %A Carreira,María J %+ Centro Singular de Investigación en Tecnoloxías Intelixentes, Universidade de Santiago de Compostela, C/Jenaro de la Fuente, s/n, Santiago de Compostela, E15782, Spain, 34 881816430, mariajose.carreira@usc.es %K computer-aided diagnoses %K computer-based biomedical applications %K dental health %K dental plaque quantification %K web-based tools %K medical informatics %D 2020 %7 3.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: In the dentistry field, the analysis of dental plaque is vital because it is the main etiological factor in the 2 most prevalent oral diseases: caries and periodontitis. In most of the papers published in the dental literature, the quantification of dental plaque is carried out using traditional, non-automated, and time-consuming indices. Therefore, the development of an automated plaque quantification tool would be of great value to clinicians and researchers. Objective: This study aimed to develop a web-based tool called DenTiUS and various clinical indices to evaluate dental plaque levels using image analysis techniques. Methods: The tool was executed as a web-based application to facilitate its use by researchers. Expert users are free to define experiments, including images from either a single patient (to observe an individual plaque growth pattern) or several patients (to perform a group characterization) at a particular moment or over time. A novel approach for detecting visible plaque has been developed as well as a new concept known as nonvisible plaque. This new term implies the classification of the remaining dental area into 3 subregions according to the risk of accumulating plaque in the near future. New metrics have also been created to describe visible and nonvisible plaque levels. Results: The system generates results tables of the quantitative analysis with absolute averages obtained in each image (indices about visible plaque) and relative measurements (indices about visible and nonvisible plaque) relating to the reference moment. The clinical indices that can be calculated are the following: plaque index of an area per intensity (API index, a value between 0 and 100), area growth index (growth rate of plaque per unit of time in hours; percentage area/hour), and area time index (the time in days needed to achieve a plaque area of 100% concerning the initial area at the same moment). Images and graphics can be obtained for a moment from a patient in addition to a full report presenting all the processing data. Dentistry experts evaluated the DenTiUS Plaque software through a usability test, with the best-scoring questions those related to the workflow efficiency, value of the online help, attractiveness of the user interface, and overall satisfaction. Conclusions: The DenTiUS Plaque software allows automatic, reliable, and repeatable quantification of dental plaque levels, providing information about area, intensity, and growth pattern. Dentistry experts recognized that this software is suitable for quantification of dental plaque levels. Consequently, its application in the analysis of plaque evolution patterns associated with different oral conditions, as well as to evaluate the effectiveness of various oral hygiene measures, can represent an improvement in the clinical setting and the methodological quality of research studies. %M 32663148 %R 10.2196/18570 %U https://www.jmir.org/2020/9/e18570 %U https://doi.org/10.2196/18570 %U http://www.ncbi.nlm.nih.gov/pubmed/32663148 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 8 %N 9 %P e19774 %T Integrating and Evaluating the Data Quality and Utility of Smart Pump Information in Detecting Medication Administration Errors: Evaluation Study %A Ni,Yizhao %A Lingren,Todd %A Huth,Hannah %A Timmons,Kristen %A Melton,Krisin %A Kirkendall,Eric %+ Division of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC 7024, Cincinnati, OH, 45229, United States, 1 5138034269, yizhao.ni@cchmc.org %K medication administration errors %K smart infusion pumps %K electronic health records %K concordance %D 2020 %7 2.9.2020 %9 Original Paper %J JMIR Med Inform %G English %X Background: At present, electronic health records (EHRs) are the central focus of clinical informatics given their role as the primary source of clinical data. Despite their granularity, the EHR data heavily rely on manual input and are prone to human errors. Many other sources of data exist in the clinical setting, including digital medical devices such as smart infusion pumps. When incorporated with prescribing data from EHRs, smart pump records (SPRs) are capable of shedding light on actions that take place during the medication use process. However, harmoniz-ing the 2 sources is hindered by multiple technical challenges, and the data quality and utility of SPRs have not been fully realized. Objective: This study aims to evaluate the quality and utility of SPRs incorporated with EHR data in detecting medication administration errors. Our overarching hypothesis is that SPRs would contribute unique information in the med-ication use process, enabling more comprehensive detection of discrepancies and potential errors in medication administration. Methods: We evaluated the medication use process of 9 high-risk medications for patients admitted to the neonatal inten-sive care unit during a 1-year period. An automated algorithm was developed to align SPRs with their medica-tion orders in the EHRs using patient ID, medication name, and timestamp. The aligned data were manually re-viewed by a clinical research coordinator and 2 pediatric physicians to identify discrepancies in medication ad-ministration. The data quality of SPRs was assessed with the proportion of information that was linked to valid EHR orders. To evaluate their utility, we compared the frequency and severity of discrepancies captured by the SPR and EHR data, respectively. A novel concordance assessment was also developed to understand the detec-tion power and capabilities of SPR and EHR data. Results: Approximately 70% of the SPRs contained valid patient IDs and medication names, making them feasible for data integration. After combining the 2 sources, the investigative team reviewed 2307 medication orders with 10,575 medication administration records (MARs) and 23,397 SPRs. A total of 321 MAR and 682 SPR dis-crepancies were identified, with vasopressors showing the highest discrepancy rates, followed by narcotics and total parenteral nutrition. Compared with EHR MARs, substantial dosing discrepancies were more commonly detectable using the SPRs. The concordance analysis showed little overlap between MAR and SPR discrepan-cies, with most discrepancies captured by the SPR data. Conclusions: We integrated smart infusion pump information with EHR data to analyze the most error-prone phases of the medication lifecycle. The findings suggested that SPRs could be a more reliable data source for medication error detection. Ultimately, it is imperative to integrate SPR information with EHR data to fully detect and mitigate medication administration errors in the clinical setting. %M 32876578 %R 10.2196/19774 %U https://medinform.jmir.org/2020/9/e19774 %U https://doi.org/10.2196/19774 %U http://www.ncbi.nlm.nih.gov/pubmed/32876578 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 7 %N 3 %P e20364 %T Twelve-Month Review of Infusion Pump Near-Miss Medication and Dose Selection Errors and User-Initiated “Good Save” Corrections: Retrospective Study %A Waterson,James %A Al-Jaber,Rania %A Kassab,Tarek %A Al-Jazairi,Abdulrazaq S %+ Medication Management Solutions, Becton, Dickinson & Company, LLC, 11 Floor, Blue Bay Tower, Business Bay, Dubai, 1197, United Arab Emirates, 971 566035154, redheroes67@icloud.com %K medication library %K smart infusion pumps %K near-miss error %K medication safety %K lookalike-soundalike %D 2020 %7 11.8.2020 %9 Original Paper %J JMIR Hum Factors %G English %X Background: There is a paucity of quantitative evidence in the current literature on the incidence of wrong medication and wrong dose administration of intravenous medications by clinicians. The difficulties of obtaining reliable data are related to the fact that at this stage of the medication administration chain, detection of errors is extremely difficult. Smart pump medication library logs and their reporting software record medication and dose selections made by users, as well as cancellations of selections and the time between these actions. Analysis of these data adds quantitative data to the detection of these kinds of errors. Objective: We aimed to establish, in a reproducible and reliable study, baseline data to show how metrics in the set-up and programming phase of intravenous medication administration can be produced from medication library near-miss error reports from infusion pumps. Methods: We performed a 12-month retrospective review of medication library reports from infusion pumps from across a facility to obtain metrics on the set-up phase of intravenous medication administration. Cancelled infusions and resolutions of all infusion alerts by users were analyzed. Decision times of clinicians were calculated from the time-date stamps of the pumps’ logs. Results: Incorrect medication selections represented 3.45% (10,017/290,807) of all medication library alerts and 22.40% (10,017/44,721) of all cancelled infusions. Of these cancelled medications, all high-risk medications, oncology medications, and all intravenous medications delivered to pediatric patients and neonates required a two-nurse check according to the local policy. Wrong dose selection was responsible for 2.93% (8533/290,807) of all alarms and 19.08% (8533/44,721) of infusion cancellations. Average error recognition to cancellation and correction times were 27.00 s (SD 22.25) for medication error correction and 26.52 s (SD 24.71) for dose correction. The mean character count of medications corrected from initial lookalike-soundalike selection errors was 13.04, with a heavier distribution toward higher character counts. The position of the word/phrase error was spread among name beginning (6991/10,017, 69.79%), middle (2144/10,017, 21.40%), and end (882/10,017, 8.80%). Conclusions: The study identified a high number of lookalike-soundalike near miss errors, with cancellation of one medication being rapidly followed by the programming of a second. This phenomenon was largely centered on initial misreadings of the beginning of the medication name, with some incidences of misreading in the middle and end portions of medication nomenclature. The value of an infusion pump showing the entire medication name complete with TALLman lettering on the interface matching that of medication labeling is supported by these findings. The study provides a quantitative appraisal of an area that has been resistant to study and measurement, which is the number of intravenous medication administration errors of wrong medication and wrong dose that occur in clinical settings. %M 32667895 %R 10.2196/20364 %U http://humanfactors.jmir.org/2020/3/e20364/ %U https://doi.org/10.2196/20364 %U http://www.ncbi.nlm.nih.gov/pubmed/32667895 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 7 %N 2 %P e15581 %T Value of Eye-Tracking Data for Classification of Information Processing–Intensive Handling Tasks: Quasi-Experimental Study on Cognition and User Interface Design %A Wegner,Stephan %A Lohmeyer,Quentin %A Wahlen,Dimitri %A Neumann,Sandra %A Groebli,Jean-Claude %A Meboldt,Mirko %+ Product Development Group Zurich, Institute of Design, Materials and Fabrication, Department of Mechanical and Process Engineering, Swiss Federal Institute of Technology in Zurich, Leonhardstrasse 21, Zürich, 8092, Switzerland, 41 446324862, stehess@ethz.ch %K human factors engineering %K mobile eye tracking %K benchmarking %K home care %K usability %K self-management %K quantitative research %K quantitative evaluation %D 2020 %7 3.6.2020 %9 Original Paper %J JMIR Hum Factors %G English %X Background: In order to give a wide range of people the opportunity to ensure and support home care, one approach is to develop medical devices that are as user-friendly as possible. This allows nonexperts to use medical devices that were originally too complicated to use. For a user-centric development of such medical devices, it is essential to understand which user interface design best supports patients, caregivers, and health care professionals. Objective: Using the benefits of mobile eye tracking, this work aims to gain a deeper understanding of the challenges of user cognition. As a consequence, its goal is to identify the obstacles to the usability of the features of two different designs of a single medical device user interface. The medical device is a patient assistance device for home use in peritoneal dialysis therapy. Methods: A total of 16 participants, with a subset of seniors (8/16, mean age 73.7 years) and young adults (8/16, mean age 25.0 years), were recruited and participated in this study. The handling cycle consisted of seven main tasks. Data analysis started with the analysis of task effectiveness for searching for error-related tasks. Subsequently, the in-depth gaze data analysis focused on these identified critical tasks. In order to understand the challenges of user cognition in critical tasks, gaze data were analyzed with respect to individual user interface features of the medical device system. Therefore, it focused on the two dimensions of dwell time and fixation duration of the gaze. Results: In total, 97% of the handling steps for design 1 and 96% for design 2 were performed correctly, with the main challenges being task 1 insert, task 2 connect, and task 6 disconnect for both designs. In order to understand the two analyzed dimensions of the physiological measurements simultaneously, the authors propose a new graphical representation. It distinguishes four different patterns to compare the eye movements associated with the two designs. The patterns identified for the critical tasks are consistent with the results of the task performance. Conclusions: This study showed that mobile eye tracking provides insights into information processing in intensive handling tasks related to individual user interface features. The evaluation of each feature of the user interface promises an optimal design by combining the best found features. In this way, manufacturers are able to develop products that can be used by untrained people without prior knowledge. This would allow home care to be provided not only by highly qualified nurses and caregivers, but also by patients themselves, partners, children, or neighbors. %M 32490840 %R 10.2196/15581 %U http://humanfactors.jmir.org/2020/2/e15581/ %U https://doi.org/10.2196/15581 %U http://www.ncbi.nlm.nih.gov/pubmed/32490840 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e18073 %T A Prospective Study of Usability and Workload of Electronic Medication Adherence Products by Older Adults, Caregivers, and Health Care Providers %A Patel,Tejal %A Ivo,Jessica %A Faisal,Sadaf %A McDougall,Aidan %A Carducci,Jillian %A Pritchard,Sarah %A Chang,Feng %+ School of Pharmacy, University of Waterloo, 10 Victoria St S, Kitchener, ON, N2G 1C5, Canada, 1 519 888 4567 ext 21337, t5patel@uwaterloo.ca %K electronic medication adherence %K usability %K workload %K geriatrics %K older adults %K mobile phone %D 2020 %7 2.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: A decreased capacity to self-manage medications results in nonadherence, medication errors, and drug-related problems in older adults. Previous research identified 80 electronic medication adherence products available to assist patients with self-management of medications. Unfortunately, the usability and workload of these products are unknown. Objective: This study aimed to examine the usability and workload of a sample of electronic medication adherence products. Methods: In a prospective, mixed methods study, a sample of older adults, health care professionals, and caregivers tested the usability and workload of 21 electronic medication adherence products. Each participant tested 5 products, one at a time, after which they completed the system usability scale (SUS) and NASA-task load index (NASA-TLX), instruments that measure the usability and workload involved in using a product. Higher SUS scores indicate more user-friendliness, whereas lower NASA-TLX raw scores indicate less workload when using a product. Results: Electronic medication adherence products required a mean of 12.7 steps (range 5-20) for the appropriate use and took, on average, 15.19 min to complete the setup tasks (range 1-56). Participants were able to complete all steps without assistance 55.3% of the time (103 out of the 186 tests were completed by 39 participants; range 0%-100%). The mean SUS and NASA-TLX raw scores were 52.8 (SD 28.7; range 0-100) and 50.0 (SD 25.7; range 4.2-99.2), respectively, revealing significant variability among the electronic medication adherence products. The most user-friendly products were found to be TimerCap travel size (mean 78.67, SD 15.57; P=.03) and eNNOVEA Weekly Planner with Advanced Auto Reminder (mean 78.13, SD 14.13; P=.049) as compared with MedReady 1700 automated medication dispenser (mean 28.63, SD 21.24). Similarly, MedReady (72.92, SD 18.69) was found to be significantly more work intensive when compared with TimerCap (29.35, SD 20.35; P=.03), e-pill MedGlider home medication management system (28.43, SD 20.80; P=.02), and eNNOVEA (28.65, SD 14.97; P=.03). The e-pill MedTime Station automatic pill dispenser with tipper (71.77, SD 21.98) had significantly more workload than TimerCap (P=.04), MedGlider (P=.03), and eNNOVEA (P=.04). Conclusions: This study demonstrated that variability exists in the usability and workload of different electronic medication adherence products among older adults, caregivers, and clinicians. With few studies having investigated the usability and workload of electronic medication adherence products, no benchmarks exist to compare the usability and workload of these products. However, our study highlights the need to assess the usability and workload of different products marketed to assist with medication taking and provides guidance to clinicians regarding electronic medication adherence product recommendations for their patients. Future development of electronic medication adherence products should ensure that the target populations of patients are able to use these products adequately to improve medication management. %M 32348292 %R 10.2196/18073 %U https://www.jmir.org/2020/6/e18073 %U https://doi.org/10.2196/18073 %U http://www.ncbi.nlm.nih.gov/pubmed/32348292 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 5 %P e17804 %T Augmented Reality–Based Rehabilitation of Gait Impairments: Case Report %A Held,Jeremia Philipp Oskar %A Yu,Kevin %A Pyles,Connor %A Veerbeek,Janne Marieke %A Bork,Felix %A Heining,Sandro-Michael %A Navab,Nassir %A Luft,Andreas Rüdiger %+ Division of Vascular Neurology and Neurorehabilitation, Department of Neurology, University of Zurich and University Hospital Zurich, Frauenklinikstrasse 26, Zurich, 8091, Switzerland, 41 44 255 5645, jeremia.held@uzh.ch %K HoloLens 2 %K gait %K rehabilitation %K stroke %K augmented reality %K sensors %D 2020 %7 26.5.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Gait and balance impairments are common in neurological diseases, including stroke, and negatively affect patients’ quality of life. Improving balance and gait are among the main goals of rehabilitation. Rehabilitation is mainly performed in clinics, which lack context specificity; therefore, training in the patient’s home environment is preferable. In the last decade, developed rehabilitation technologies such as virtual reality and augmented reality (AR) have enabled gait and balance training outside clinics. Here, we propose a new method for gait rehabilitation in persons who have had a stroke in which mobile AR technology and a sensor-based motion capture system are combined to provide fine-grained feedback on gait performance in real time. Objective: The aims of this study were (1) to investigate manipulation of the gait pattern of persons who have had a stroke based on virtual augmentation during overground walking compared to walking without AR performance feedback and (2) to investigate the usability of the AR system. Methods: We developed the ARISE (Augmented Reality for gait Impairments after StrokE) system, in which we combined a development version of HoloLens 2 smart glasses (Microsoft Corporation) with a sensor-based motion capture system. One patient with chronic minor gait impairment poststroke completed clinical gait assessments and an AR parkour course with patient-centered performance gait feedback. The movement kinematics during gait as well as the usability and safety of the system were evaluated. Results: The patient changed his gait pattern during AR parkour compared to the pattern observed during the clinical gait assessments. He recognized the virtual objects and ranked the usability of the ARISE system as excellent. In addition, the patient stated that the system would complement his standard gait therapy. Except for the symptom of exhilaration, no adverse events occurred. Conclusions: This project provided the first evidence of gait adaptation during overground walking based on real-time feedback through visual and auditory augmentation. The system has potential to provide gait and balance rehabilitation outside the clinic. This initial investigation of AR rehabilitation may aid the development and investigation of new gait and balance therapies. %M 32452815 %R 10.2196/17804 %U http://mhealth.jmir.org/2020/5/e17804/ %U https://doi.org/10.2196/17804 %U http://www.ncbi.nlm.nih.gov/pubmed/32452815 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 3 %P e14405 %T Automated Respiratory Rate Counter to Assess Children for Symptoms of Pneumonia: Protocol for Cross-Sectional Usability and Acceptability Studies in Ethiopia and Nepal %A Baker,Kevin %A Maurel,Alice %A Ward,Charlotte %A Getachew,Dawit %A Habte,Tedila %A McWhorter,Cindy %A LaBarre,Paul %A Karlström,Jonas %A Petzold,Max %A Källander,Karin %+ Malaria Consortium, The Green House, 224-254 Cambridge Heath Road, London, E2 9DA, United Kingdom, 44 781 126 6539, k.baker@malariaconsortium.org %K community health worker %K pneumonia %K child %K respiratory rate %K Nepal %K Ethiopia %D 2020 %7 30.3.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Manually counting a child’s respiratory rate (RR) for 60 seconds using an acute respiratory infection timer is the World Health Organization (WHO) recommended method for detecting fast breathing as a sign of pneumonia. However, counting the RR is challenging and misclassification of an observed rate is common, often leading to inappropriate treatment. To address this gap, the acute respiratory infection diagnostic aid (ARIDA) project was initiated in response to a call for better pneumonia diagnostic aids and aimed to identify and assess automated RR counters for classifying fast breathing pneumonia when used by front-line health workers in resource-limited community settings and health facilities. The Children’s Automated Respiration Monitor (ChARM), an automated RR diagnostic aid using accelerometer technology developed by Koninklijke Philips NV, and the Rad-G, a multimodal RR diagnostic and pulse oximeter developed by Masimo, were the two devices tested in these studies conducted in the Southern Nations, Nationalities, and Peoples’ Region in Ethiopia and in the Karnali region in Nepal. Objective: In these studies, we aimed to understand the usability of two new automated RR diagnostic aids for community health workers (CHWs; health extension workers [Ethiopia] and female community health volunteers [Nepal]) and their acceptability to CHWs in Ethiopia and Nepal, first-level health facility workers (FLHFWs) in Ethiopia only, and caregivers in both Ethiopia and Nepal. Methods: This was a prospective, cross-sectional study with a mixed methods design. CHWs and FLHFWs were trained to use both devices and provided with refresher training on all WHO requirements to assess fast breathing. Immediately after training, CHWs were observed using ARIDA on two children. Routine pneumonia case management consultations for children aged 5 years and younger and the device used for these consultations between the first and second consultations were recorded by CHWs in their patient log books. CHWs were observed a second time after 2 months. Semistructured interviews were also conducted with CHWs, FLHFWs, and caregivers. The proportion of consultations with children aged 5 years and younger where CHWs using an ARIDA and adhered to all WHO requirements to assess fast breathing and device manufacturer instructions for use after 2 months will be calculated. Qualitative data from semistructured interviews will be analyzed using a thematic framework approach. Results: The ARIDA project was funded in November 2015, and data collection was conducted between April and December 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in 2020. Conclusions: This is the first time the usability and acceptability of automated RR counters in low-resource settings have been evaluated. Outcomes will be relevant for policy makers and are important for future research of this new class of diagnostic aids for the management of children with suspected pneumonia. International Registered Report Identifier (IRRID): DERR1-10.2196/14405 %M 32224491 %R 10.2196/14405 %U http://www.researchprotocols.org/2007/3/e14405/ %U https://doi.org/10.2196/14405 %U http://www.ncbi.nlm.nih.gov/pubmed/32224491 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 2 %P e14189 %T Usability of the Turkish Translation of the Dutch Talking Touch Screen Questionnaire for Physical Therapy Patients With a Turkish Background: Qualitative Study %A Welbie,Marlies %A Wittink,Harriet %A Bozkurt,Sahin %A Coban,Tugba %A Devillé,Walter LJM %+ Research Group Lifestyle and Health, Research Center Healthy and Sustainable Living, Utrecht University of Applied Sciences, Postbus 12011, Utrecht, 3501 AA Utrecht, Netherlands, 31 638192100, marlies.welbie@hu.nl %K mHealth %K eHealth %K surveys and questionnaires %K physical therapy specialty %K qualitative research %D 2020 %7 13.2.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: The Turkish translation of the Dutch Talking Touch Screen Questionnaire (TTSQ) has been developed to help physical therapy patients with a Turkish background in the Netherlands to autonomously elucidate their health problems and impairments and set treatment goals, regardless of their level of health literacy. Objective: The aim of this study was to evaluate the usability of the Turkish TTSQ for physical therapy patients with a Turkish background with diverse levels of health literacy and experience in using mobile technology. Methods: The qualitative Three-Step Test-Interview method was carried out to gain insight into the usability of the Turkish TTSQ. A total of 10 physical therapy patients participated. The interview data were analyzed using a thematic content analysis approach aimed at determining the accuracy and completeness with which participants completed the questionnaire (effectiveness), the time it took participants to complete the questionnaire (efficiency), and the extent to which the participants were satisfied with the ease of use of the questionnaire (satisfaction). The problems encountered by the participants in this study were given a severity rating, which was used to provide a rough estimate of the need for additional usability improvements. Results: No participant in this study was able to complete the questionnaire without encountering at least one usability problem. A total of 17 different kinds of problems were found. On the basis of their severity score, 3 problems that should be addressed during future development of the tool were “Not using the navigation function of the photo gallery in Question 4 causing the participant to not see all presented response items;” “Touching the text underneath a photo in Question 4 to select an activity instead of touching the photo itself, causing the activity not to be selected;” and “Pushing too hard or tapping too softly on the touch screen causing the touch screen to not respond.” The data on efficiency within this study were not valid and are, therefore, not reported in this study. No participant was completely satisfied or dissatisfied with the overall ease of use of the Turkish TTSQ. Two participants with no prior experience of using tablet computers felt that, regardless of what kinds of improvement might be made, it would just be too difficult for them to learn to work with the device. Conclusions: As with the Dutch TTSQ, the Turkish TTSQ needs improvement before it can be released. The results of this study confirm the conclusion of the Dutch TTSQ study that participants with low levels of education and little experience in using mobile technology are less able to operate the TTSQ effectively. Using a Dutch speaking interviewer and Turkish interpreter has had a negative effect on data collection in this study. %M 32053112 %R 10.2196/14189 %U http://formative.jmir.org/2020/2/e14189/ %U https://doi.org/10.2196/14189 %U http://www.ncbi.nlm.nih.gov/pubmed/32053112 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 6 %N 4 %P e15103 %T Remote Patient Monitoring in Adults Receiving Transfusion or Infusion for Hematological Disorders Using the VitalPatch and accelerateIQ Monitoring System: Quantitative Feasibility Study %A Tonino,Rik Paulus Bernardus %A Larimer,Karen %A Eissen,Okke %A Schipperus,Martin Roelof %+ Haga Teaching Hospital, Els Borst-Eilersplein 275, The Hague, 2545 AA, Netherlands, 31 623248432, Toninorik@gmail.com %K infusions, intravenous %K erythrocyte transfusion %K transfusion reaction %K wearable electronic devices %K telemedicine %D 2019 %7 2.12.2019 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Frequent vital sign monitoring during and after transfusion of blood products and certain chemotherapies or immunotherapies is critical for detecting infusion reactions and treatment management in patients. Currently, patients return home with instructions to contact the clinic if they feel unwell. Continuous monitoring of vital signs for hematological patients treated with immunotherapy or chemotherapy or receiving blood transfusions using wearable electronic biosensors during and post treatment may improve the safety of these treatments and make remote data collection in an outpatient care setting possible. Objective: This study aimed to evaluate patient experiences with the VitalPatch wearable sensor (VitalConnect) and to evaluate the usability of data generated by the physIQ accelerateIQ monitoring system for the investigator and nurse. Methods: A total of 12 patients with hematological disorders receiving red blood cell transfusions, an intravenous (IV) proteasome inhibitor, or an IV immunotherapy agent were included in the study and wore the VitalPatch for 12 days. Patients completed questionnaires focusing on wearability and nurses completed questionnaires focusing on the usability of the VitalPatch. Results: A total of 12 patients were enrolled over 9 months, with 4 receiving red blood cell transfusions, 4 receiving IV proteasome inhibitors, and 4 receiving IV immunotherapy. These patients were treated for diseases such as multiple myeloma, myelodysplastic syndrome, and non-Hodgkin lymphoma. Of these patients, 83% (10/12) were aged 60 years and older. A total of 4 patients (4/12, 33%) withdrew from the study (3 because of skin irritation and 1 because of patch connection issues). Patients wore biosensor patches at baseline and for 1-week post administration. Patient-reported outcomes (PROs) were collected at baseline, day 1, day 5, and day 8. No difference in the PRO was observed when nurses or patients applied the patch. PRO data indicated minimal impact on the patient’s life. Ease of use, influence on sleep, impact on follow-up of health, or discomfort with continuous monitoring did not change between baseline and day 8. Changes in PRO were observed on day 5, where a 20% (2/10) increase in skin irritation was reported. Withdrawals because of skin irritation were reported in all cases when wearing the second patch. Nurses reported the placement of the VitalPatch to be easy and felt measurements to be reliable. Conclusions: Generally, the VitalPatch was well tolerated and shown to be an attractive device because of its wearability and low impact on daily activities in patients, therefore making it suitable for implementation in future studies. %M 31789596 %R 10.2196/15103 %U http://humanfactors.jmir.org/2019/4/e15103/ %U https://doi.org/10.2196/15103 %U http://www.ncbi.nlm.nih.gov/pubmed/31789596 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 9 %P e14474 %T User Experience of 7 Mobile Electroencephalography Devices: Comparative Study %A Radüntz,Thea %A Meffert,Beate %+ Mental Health and Cognitive Capacity, Federal Institute for Occupational Safety and Health, Nöldnerstr 40-42, Berlin, 10317, Germany, 49 30 51548 4418, raduentz.thea@baua.bund.de %K wearable devices %K user experience %K electroencephalography %K mobile applications %K electrodes %K dry electrodes %D 2019 %7 03.09.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Registration of brain activity has become increasingly popular and offers a way to identify the mental state of the user, prevent inappropriate workload, and control other devices by means of brain-computer interfaces. However, electroencephalography (EEG) is often related to user acceptance issues regarding the measuring technique. Meanwhile, emerging mobile EEG technology offers the possibility of gel-free signal acquisition and wireless signal transmission. Nonetheless, user experience research about the new devices is lacking. Objective: This study aimed to evaluate user experience aspects of emerging mobile EEG devices and, in particular, to investigate wearing comfort and issues related to emotional design. Methods: We considered 7 mobile EEG devices and compared them for their wearing comfort, type of electrodes, visual appearance, and subjects’ preference for daily use. A total of 24 subjects participated in our study and tested every device independently of the others. The devices were selected in a randomized order and worn on consecutive day sessions of 60-min duration. At the end of each session, subjects rated the devices by means of questionnaires. Results: Results indicated a highly significant change in maximal possible wearing duration among the EEG devices (χ26=40.2, n=24; P<.001). Regarding the visual perception of devices’ headset design, results indicated a significant change in the subjects’ ratings (χ26=78.7, n=24; P<.001). Results of the subjects’ ratings regarding the practicability of the devices indicated highly significant differences among the EEG devices (χ26=83.2, n=24; P<.001). Ranking order and posthoc tests offered more insight and indicated that pin electrodes had the lowest wearing comfort, in particular, when coupled with a rigid, heavy headset. Finally, multiple linear regression for each device separately revealed that users were not willing to accept less comfort for a more attractive headset design. Conclusions: The study offers a differentiated look at emerging mobile and gel-free EEG technology and the relation between user experience aspects and device preference. Our research could be seen as a precondition for the development of usable applications with wearables and contributes to consumer health informatics and health-enabling technologies. Furthermore, our results provided guidance for the technological development direction of new EEG devices related to the aspects of emotional design. %M 31482852 %R 10.2196/14474 %U https://mhealth.jmir.org/2019/9/e14474/ %U https://doi.org/10.2196/14474 %U http://www.ncbi.nlm.nih.gov/pubmed/31482852 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 6 %N 2 %P e12055 %T Development of a Clinical Interface for a Novel Newborn Resuscitation Device: Human Factors Approach to Understanding Cognitive User Requirements %A Pickup,Laura %A Lang,Alexandra %A Shipley,Lara %A Henry,Caroline %A Carpenter,James %A McCartney,Damon %A Butler,Matthew %A Hayes-Gill,Barrie %A Sharkey,Don %+ Optics and Photonics Research Group, Department of Electrical and Electronic Engineering, University of Nottingham, University Park, Nottingham, NG7 2RD, United Kingdom, 01159515547, Barrie.Hayes-Gill@nottingham.ac.uk %K neonatal resuscitation %K medical device %K human factors %K user-centred design %K applied cognitive task analysis %D 2019 %7 8.6.2019 %9 Original Paper %J JMIR Hum Factors %G English %X Background: A novel medical device has been developed to address an unmet need of standardizing and facilitating heart rate recording during neonatal resuscitation. In a time-critical emergency resuscitation, where failure can mean death of an infant, it is vital that clinicians are provided with information in a timely, precise, and clear manner to capacitate appropriate decision making. This new technology provides a hands-free, wireless heart rate monitoring solution that easily fits the clinical pathway and procedure for neonatal resuscitation. Objective: This study aimed to understand the requirements of the interface design for a new device by using a human factors approach. This approach combined a traditional user-centered design approach with an applied cognitive task analysis to understand the tasks involved, the cognitive requirements, and the potential for error during a neonatal resuscitation scenario. Methods: Fourteen clinical staff were involved in producing the final design requirements. Two pediatric doctors supported the development of a visual representation of the activities associated with neonatal resuscitation. This design was used to develop a scenario-based workshop. Two workshops were carried out in parallel and involved three pediatric doctors, three neonatal nurses, two advance neonatal practitioners, and four midwives. Both groups came together at the end to reflect on the findings from the separate sessions. Results: The outputs of this study have provided a comprehensive description of information requirements during neonatal resuscitation and enabled product developers to understand the preferred requirements of the user interface design for the device. The study raised three key areas for the designers to consider, which had not previously been highlighted: (1) interface layout and information priority, as heart rate should be central and occupy two-thirds of the screen; (2) size and portability, to enable positioning of the product local to the baby’s head and allow visibility from all angles; and (3) auditory feedback, to support visual information on heart rate rhythm and reliability of the trace with an early alert for intervention while avoiding parental distress. Conclusions: This study demonstrates the application of human factors and the applied cognitive task analysis method, which identified previously unidentified user requirements. This methodology provides a useful approach to aid development of the clinical interface for medical devices. %M 31199321 %R 10.2196/12055 %U http://humanfactors.jmir.org/2019/2/e12055/ %U https://doi.org/10.2196/12055 %U http://www.ncbi.nlm.nih.gov/pubmed/31199321 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 6 %N 2 %P e10366 %T A Hazard Analysis of Class I Recalls of Infusion Pumps %A Gao,Xuemei %A Wen,Qiang %A Duan,Xiaolian %A Jin,Wei %A Tang,Xiaohong %A Zhong,Ling %A Xia,Shitao %A Feng,Hailing %A Zhong,Daidi %+ Bioengineering College, Chongqing University, Shazheng Street 174, Shapingba, Chongqing, 400044, China, 86 2365102507, daidi.zhong@hotmail.com %K infusion pump %K risk management %K equipment failure %K hazard analysis and critical control points %K man-machine systems %D 2019 %7 03.05.2019 %9 Original Paper %J JMIR Hum Factors %G English %X Background: The adverse event report of medical devices is one of the postmarket surveillance tools used by regulators to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. However, with the development of the related technologies and market, the number of adverse events has also been on the rise, which in turn results in the need to develop efficient tools that help to analyze adverse events monitoring data and to identify risk signals. Objective: This study aimed to establish a hazard classification framework of medical devices and to apply it over practical adverse event data on infusion pumps. Subsequently, it aimed to analyze the risks of infusion pumps and to provide a reference for the risk management of this type of device. Methods: The authors define a general hierarchical classification of medical device hazards. This classification is combined with the Trace Intersecting Theory to form a human-machine-environment interaction model. Such a model was applied to the dataset of 2001 to 2017 class I infusion pump recalls extracted from the Food and Drug Administration (FDA) website. This dataset does not include cases involving illegal factors. Results: The proposed model was used for conducting hazard analysis on 70 cases of class I infusion pump recalls by the FDA. According to the analytical results, an important source of product technical risk was that the infusion pumps did not infuse accurate dosage (ie, over- or underdelivery of fluid). In addition, energy hazard and product component failure were identified as the major hazard form associated with infusion pump use and as the main direct cause for adverse events in the studied cases, respectively. Conclusions: The proposed human-machine-environment interaction model, when applied to adverse event data, can help to identify the hazard forms and direct causes of adverse events associated with medical device use. %M 31066695 %R 10.2196/10366 %U http://humanfactors.jmir.org/2019/2/e10366/ %U https://doi.org/10.2196/10366 %U http://www.ncbi.nlm.nih.gov/pubmed/31066695 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 6 %N 2 %P e12553 %T Evaluation of an Anesthesia Dashboard Functional Model Based on a Manufacturer-Independent Communication Standard: Comparative Feasibility Study %A Ohligs,Marian %A Pereira,Carina %A Voigt,Verena %A Koeny,Marcus %A Janß,Armin %A Rossaint,Rolf %A Czaplik,Michael %+ Department of Anesthesiology, Faculty of Medicine, Rheinisch-Westfälische Technische Hochschule Aachen University, Pauwelsstrasse 30, Aachen, 52074, Germany, 49 241 80 ext 83136, mohligs@ukaachen.de %K operating room %K anesthesia %K interconnection %K networking %K human-computer interaction %K process optimization %K intelligent alarms %K decision-support systems %K 11073 SDC %K service-oriented device connectivity %D 2019 %7 01.05.2019 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Current anesthesia workspaces consist of several technical devices, such as patient monitors, anesthesia machines, among others. Commonly, they are produced by different manufacturers; thus, they differ in terms of their modus operandi, user interface, and representation of alarms. Merging the information from these devices using a single joint protocol and displaying it in a single graphical user interface could lead to a general improvement in perioperative management. For this purpose, the recently approved and published Institute of Electrical and Electronics Engineers 11073 service-oriented device connectivity standard was implemented. Objective: This paper aims to develop and then evaluate an anesthesia workstation (ANWS) functional model in terms of usability, fulfillment of clinical requirements, and expected improvements in patient safety. Methods: To compare the self-developed ANWS with the conventional system, a pilot observational study was conducted at the University Hospital Aachen, Germany. A total of 5 anesthesiologists were asked to perform different tasks using the ANWS and then the conventional setup. For evaluation purposes, response times were measured and an interaction-centered usability test with an eye-tracking system was carried out. Finally, the subjects were asked to fill in a questionnaire in order to measure user satisfaction. Results: Response times were significantly higher when using the ANWS, but decreased considerably after one repetition. Furthermore, usability was rated as excellent (≥95) according to the System Usability Scale score, and the majority of clinical requirements were met. Conclusions: In general, the results were highly encouraging, considering that the ANWS was only a functional model, as well as the lack of training of the participants. However, further studies are necessary to improve the universal user interface and the interplay of the various networked devices. %M 31042150 %R 10.2196/12553 %U http://humanfactors.jmir.org/2019/2/e12553/ %U https://doi.org/10.2196/12553 %U http://www.ncbi.nlm.nih.gov/pubmed/31042150 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 6 %N 1 %P e11598 %T Supporting Older Adults in Exercising With a Tablet: A Usability Study %A Mehra,Sumit %A Visser,Bart %A Cila,Nazli %A van den Helder,Jantine %A Engelbert,Raoul HH %A Weijs,Peter JM %A Kröse,Ben JA %+ CREATE-IT Applied Research Centre, Faculty of Digital Media and Creative Industries, Amsterdam University of Applied Sciences, Wibautstraat 2-4, Amsterdam, 1091GM, Netherlands, 31 0621156956, s.mehra@hva.nl %K frail elderly %K aged %K activities of daily living %K exercise %K health behavior %K telemedicine %K mobile devices %K tablet computers %K usability testing %K mobile phone %D 2019 %7 01.02.2019 %9 Original Paper %J JMIR Hum Factors %G English %X Background: For older adults, physical activity is vital for maintaining their health and ability to live independently. Home-based programs can help them achieve the recommended exercise frequency. An application for a tablet computer was developed to support older adults in following a personal training program. It featured goal setting, tailoring, progress tracking, and remote feedback. Objective: In line with the Medical Research Council Framework, which prescribes thorough testing before evaluating the efficacy with a randomized controlled trial, the aim of this study was to assess the usability of a tablet-based app that was designed to support older adults in doing exercises at home. Methods: A total of 15 older adults, age ranging from 69 to 99 years old, participated in a usability study that utilized a mixed-methods approach. In a laboratory setting, novice users were asked to complete a series of tasks while verbalizing their ongoing thoughts. The tasks ranged from looking up information about exercises and executing them to tailoring a weekly exercise schedule. Performance errors and time-on-task were calculated as proxies of effective and efficient usage. Overall satisfaction was assessed with a posttest interview. All responses were analyzed independently by 2 researchers. Results: The participants spent 13-85 seconds time-on-task. Moreover, 79% (11/14)-100% (14/14) participants completed the basic tasks with either no help or after having received 1 hint. For expert tasks, they needed a few more hints. During the posttest interview, the participants made 3 times more positive remarks about the app than negative remarks. Conclusions: The app that was developed to support older adults in doing exercises at home is usable by the target audience. First-time users were able to perform basic tasks in an effective and efficient manner. In general, they were satisfied with the app. Tasks that were associated with behavior execution and evaluation were performed with ease. Complex tasks such as tailoring a personal training schedule needed more effort. Learning effects, usefulness, and long-term satisfaction will be investigated through longitudinal follow-up studies. %M 30707106 %R 10.2196/11598 %U http://humanfactors.jmir.org/2019/1/e11598/ %U https://doi.org/10.2196/11598 %U http://www.ncbi.nlm.nih.gov/pubmed/30707106 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 11 %P e191 %T Experience of Emergency Department Patients With Using the Talking Pole Device: Prospective Interventional Descriptive Study %A Yoo,Junsang %A Soh,Ji Yeong %A Lee,Wan Hyoung %A Chang,Dong Kyung %A Lee,Se Uk %A Cha,Won Chul %+ Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea, 82 234102053, wc.cha@samsung.com %K emergency department %K health information technology %K Internet of Things %K mobile phone %K patient engagement %D 2018 %7 22.11.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Patient engagement is important. However, it can be difficult in emergency departments (EDs). Objective: The aim of this study was to evaluate the satisfaction of ED patients using a patient-friendly health information technology (HIT) device, the “Talking Pole,” and to assess the factors relevant to their satisfaction. Methods: This study was conducted in May 2017 at the ED of a tertiary hospital. The “Talking Pole” is a smartphone-based device attached to a intravenous infusion pole with sensors. It is capable of sensing patient movement and fluid dynamics. In addition, it provides clinical information from electronic medical records to patients and serves as a wireless communication tool between patients and nurses. Patients and caregivers who entered the observation room of the ED were selected for the study. The “Talking Pole” devices were provided to all participants, regardless of their need for an intravenous pole upon admittance to the ED. After 2 hours, each participant was given an 18-item questionnaire created for this research, measured on a 5-point Likert scale, regarding their satisfaction with “Talking Pole.” Results: Among 52 participants recruited, 54% (28/52) were patients and the remaining were caregivers. In total, 38% (20/52) were male participants; the average age was 54.6 (SD 12.9) years, and 63% (33/52) of the participants were oncology patients and their caregivers. The overall satisfaction rate was 4.17 (SD 0.79 ) points. Spearman correlation coefficient showed a strong association of “overall satisfaction” with “comparison to the previous visit” (ρ=.73 ), “perceived benefit” (ρ=.73), “information satisfaction” (ρ=.70), and “efficiency” (ρ=.70). Conclusions: In this study, we introduced a patient-friendly HIT device, the “Talking Pole.” Its architecture focused on enhancing information delivery, which is regarded as a bottleneck toward achieving patient engagement in EDs. Patient and caregiver satisfaction with the “Talking Pole” was positive in the ED environment. In particular, correlation coefficient results improved our understanding about patients’ satisfaction, HIT devices, and services used in the ED. %M 30467105 %R 10.2196/mhealth.9676 %U http://mhealth.jmir.org/2018/11/e191/ %U https://doi.org/10.2196/mhealth.9676 %U http://www.ncbi.nlm.nih.gov/pubmed/30467105 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 7 %P e10126 %T A Novel 12-Lead Electrocardiographic System for Home Use: Development and Usability Testing %A Steijlen,Annemarijn SM %A Jansen,Kaspar MB %A Albayrak,Armagan %A Verschure,Derk O %A Van Wijk,Diederik F %+ Design Engineering, Faculty of Industrial Design Engineering, Delft University of Technology, 32-B-3-040, Landbergstraat 15, Delft, 2628 CE, Netherlands, 31 152781819, a.s.m.steijlen@tudelft.nl %K 12-lead ECG system %K electrocardiography %K home use %K handheld %K user-centered design %D 2018 %7 30.07.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Cardiovascular diseases (CVD) are the leading cause of morbidity and mortality worldwide. Early diagnosis is of pivotal importance for patients with cardiac arrhythmias and ischemia to minimize the consequences like strokes and myocardial infarctions. The chance of capturing signals of arrhythmias or ischemia is substantially high when a 12-lead electrocardiogram (ECG) can be recorded at the moment when a patient experiences the symptoms. However, until now, available diagnostic systems (Holter monitors and other wearable ECG sensors) have not enabled patients to record a reliable 12-lead ECG at home. Objective: The objective of this project was to develop a user-friendly system that enables persons with cardiac complaints to record a reliable 12-lead ECG at home to improve the diagnostic process and, consequently, reduce the time between the onset of symptoms and adequate treatment. Methods: Using an iterative design approach, ECGraph was developed. The system consists of an ECG measurement system and a mobile app, which were developed with the help of several concept tests. To evaluate the design, a prototype of the final design was built and a final technical performance test and usability test were executed. Results: The ECG measurement system consists of a belt and 4 limb straps. Ten wet Ag/AgCl electrodes are placed in the belt to optimize skin-electrode contact. The product is controlled via an app on the mobile phone of the user. Once a person experiences symptoms, he or she can put on the belt and record ECGs within a few minutes. Short instructions, supported by visualizations, offer guidance during use. ECGs are sent wirelessly to the caregiver, and the designated expert can quickly interpret the results. Usability tests with the final prototype (n=6) showed that the participants were able to put on the product within 8 minutes during first-time use. However, we expect that the placement of the product can be executed faster when the user becomes more familiar with the product. Areas of improvement focus mainly on confidence during product use. In the technical performance test, a 12-lead ECG was made and reproduced 6 times. Conclusions: We developed a new 12-lead ECG system for home use. The product is expected to be more user-friendly than current hospital ECG systems and is designed to record more reliable data than current ECG systems for home use, which makes it suitable for expert interpretation. The system has great potential to be incorporated into an outpatient practice, so that arrhythmias and ischemia can be diagnosed and treated as early as possible. %M 30061094 %R 10.2196/10126 %U http://mhealth.jmir.org/2018/7/e10126/ %U https://doi.org/10.2196/10126 %U http://www.ncbi.nlm.nih.gov/pubmed/30061094 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 1 %N 2 %P e10975 %T Usability and Acceptability of a Home Blood Pressure Telemonitoring Device Among Community-Dwelling Senior Citizens With Hypertension: Qualitative Study %A Albrecht,Lauren %A Wood,Peter W %A Fradette,Miriam %A McAlister,Finlay A %A Rabi,Doreen %A Boulanger,Pierre %A Padwal,Raj %+ Department of Pediatrics, University of Alberta, 5-147 Edmonton Clinic Health Academy, Edmonton, AB, T6G 1C9, Canada, 1 780 492 9682, lauren.albrecht@ualberta.ca %K blood pressure %K telemonitoring %K community-dwelling %K qualitative %D 2018 %7 24.07.2018 %9 Original Paper %J JMIR Aging %G English %X Background: Hypertension is a major cause of cardiovascular disease in older individuals. To ensure that blood pressure (BP) levels are within the optimal range, accurate BP monitoring is required. Contemporary hypertension clinical practice guidelines strongly endorse the use of home BP measurement as a preferred method of BP monitoring for individuals with hypertension. The benefits of home BP monitoring may be optimized when measurements are telemonitored to care providers; however, this may be challenging for older individuals with less technological capabilities. Objective: The objective of this qualitative study was to examine the usability and acceptability of a home BP telemonitoring device among senior citizens. Methods: We conducted a qualitative descriptive study. Following a 1-week period of device use, individual, semistructured interviews were conducted. Interview audio recordings were anonymized, de-identified, and transcribed verbatim. We performed thematic analysis on interview transcripts. Results: Seven senior citizens participated in the usability testing of the home BP telemonitoring device. Participants comprised females (n=4) and males (n=3) with a mean age of 86 years (range, 70-95 years). Overall, eight main themes were identified from the interviews: (1) positive features of the device; (2) difficulties or problems with the device; (3) device was simple to use; (4) comments about wireless capability and components; (5) would recommend device to someone else; (6) would use device in future; (7) suggestions for improving the device; and (8) assistance to use device. Additional subthemes were also identified. Conclusions: Overall, the home BP telemonitoring device had very good usability and acceptability among community-dwelling senior citizens with hypertension. To enhance its long-term use, few improvements were noted that may mitigate some of the relatively minor challenges encountered by the target population. %M 31518242 %R 10.2196/10975 %U http://aging.jmir.org/2018/2/e10975/ %U https://doi.org/10.2196/10975 %U http://www.ncbi.nlm.nih.gov/pubmed/31518242 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 3 %N 1 %P e1 %T Health Care Professionals’ Clinical Perspectives on Glycemic Control and Satisfaction With a New Blood Glucose Meter With a Color Range Indicator: Online Evaluation in India, Russia, China, and the United States %A Grady,Mike %A Katz,Laurence Barry %A Anderson,Pamela %A Levy,Brian Leonard %+ LifeScan Scotland Ltd, Beechwood Park North, Inverness, IV2 3ED, United Kingdom, 44 1463 721889 ext 1889, mgrady@its.jnj.com %K color range indicator %K blood glucose meter %K self-monitoring of blood glucose %K health care professionals %D 2018 %7 09.01.2018 %9 Original Paper %J JMIR Diabetes %G English %X Background: We previously demonstrated in patients with diabetes that displaying blood glucose results in association with color improved their ability to interpret glucose results. Objective: The objective of this study was to investigate the perceptions of health care professionals (HCPs) in specific countries about the value of color on a new glucose meter and to determine if HCP perspectives among countries differ on the value of this approach in clinical practice. Methods: A total of 180 HCPs, including 105 endocrinologists, 34 primary care physicians, 25 diabetes educators, and 16 pharmacists, were recruited from India (n=50), Russia (n=50), China (n=50), and the United States (n=30). These HCPs experienced the OneTouch Select Plus Simple glucose meter online from their own office computer using interactive demonstrations (webpages, meter simulator, and video clips). After providing demographic and current clinical practice insights, HCPs responded to questions about the utility of the color-enhanced glucose meter. Results: Mean age and years in their current professional role for the 180 HCPs was 41.3 (SD 8.1) and 13.3 (SD 6.8) years for endocrinologists, 41.3 (SD 8.3) and 14.1 (SD 6.8) years for primary care physicians, 37.5 (SD 8.7) and 12.7 (SD 6.8) years for diabetes educators, and 35.9 (SD 5.3) and 9.5 (SD 5.2) years for pharmacists. In all, 88% (44/50) of Russian and 83% (25/30) of American HCPs said their patients find it easy to recognize low, in-range, or high blood glucose results compared to 56% (28/50) of HCPs in China and 42% (21/50) in India. Regardless of country, HCPs had less confidence that their patients act on blood glucose results with 52% (26/50) in Russia, 63% (19/30) in the United States, 60% (30/50) in China, and 40% (20/50) in India responding positively. During the interactive online meter experience, HCPs from all countries responded positively to questions about a meter with color features. After reflecting on the value of this meter, most HCPs strongly agreed or agreed their patients would be more inclined to act on results using a meter with color features (Russia: 92%, 46/50; United States: 70%, 21/30; China: 98%, 49/50; India: 94%, 47/50). They also said that color was particularly useful for patients with lower numeracy or education who may struggle with interpreting results (Russia: 98%, 49/50; United States: 77%, 23/30; China: 100%, 50/50; India: 82%, 41/50). Conclusions: This multicountry online study provides evidence that HCPs had high overall satisfaction with the OneTouch Select Plus glucose meter, which uses color-coded information to assist patients with interpreting blood glucose results. This may be especially helpful in patient populations with low numeracy or literacy and limited access to health care and direct interaction with HCPs. %M 30291071 %R 10.2196/diabetes.9143 %U http://diabetes.jmir.org/2018/1/e1/ %U https://doi.org/10.2196/diabetes.9143 %U http://www.ncbi.nlm.nih.gov/pubmed/30291071 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 5 %N 1 %P e1 %T Second Version of Google Glass as a Wearable Socio-Affective Aid: Positive School Desirability, High Usability, and Theoretical Framework in a Sample of Children with Autism %A Sahin,Ned T %A Keshav,Neha U %A Salisbury,Joseph P %A Vahabzadeh,Arshya %+ Brain Power, 1 Broadway, Cambridge, MA,, United States, 1 617 514 7300, sahin@post.harvard.edu %K autism %K technology %K digital health %K augmented reality %K virtual reality %K smartglasses %K usability %K schools %K education %K classroom %K IDEA %K IEP %K special education %D 2018 %7 04.01.2018 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Computerized smartglasses are being developed as an assistive technology for daily activities in children and adults with autism spectrum disorder (ASD). While smartglasses may be able to help with educational and behavioral needs, their usability and acceptability in children with ASD is largely unknown. There have been reports of negative social perceptions surrounding smartglasses use in mainstream populations, a concern given that assistive technologies may already carry their own stigma. Children with ASD may also have a range of additional behavioral, developmental, and social challenges when asked to use this emerging technology in school and home settings. Objective: The usability and acceptability of Glass Enterprise Edition (Glass), the successor to Google Glass smartglasses, were explored in children with ASD and their caregivers. Methods: Eight children with ASD and their caregivers were recruited to attend a demonstration session with Glass smartglasses the week they were publicly released. The children had a wide range of ability, including limited speech to speaking, and represented a full range of school ages (6 to 17 years). Children and caregivers were interviewed about their experience of using the smartglasses and whether they would use them at school and home. Results: All 8 children succeeded in using Glass and did not feel stressed (8/8, 100%) or experience any overwhelming sensory or emotional issues during the session (8/8, 100%). All 8 children (8/8, 100%) endorsed that they would be willing to wear and use the device in both home and school settings. Caregivers felt the experience was fun for the children (8/8, 100%), and most caregivers felt the experience was better than they had expected (6/8, 75%). Conclusions: A wide age and ability range of children with ASD used Glass immediately after it was released and found it to be usable and acceptable. Despite concerns about potential stigma or social acceptability, all of the children were prepared to use the technology in both home and school settings. Encouragingly, most caregivers noted a very positive response. There were no behavioral, developmental, or social- or stigma-related concerns during or after the session. Smartglasses may be a useful future technology for children with ASD and are readily accepted for use by children with ASD and their caregivers. %M 29301738 %R 10.2196/humanfactors.8785 %U http://humanfactors.jmir.org/2018/1/e1/ %U https://doi.org/10.2196/humanfactors.8785 %U http://www.ncbi.nlm.nih.gov/pubmed/29301738 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 4 %N 4 %P e31 %T Challenges During Implementation of a Patient-Facing Mobile App for Surgical Rehabilitation: Feasibility Study %A Lau,Annie YS %A Piper,Kalman %A Bokor,Desmond %A Martin,Paige %A Lau,Victor SL %A Coiera,Enrico %+ Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University, Level 6/75 Talavera Rd Macquarie Park, Sydney, 2109, Australia, 61 431599890, annie.lau@mq.edu.au %K mobile application %K mobile health %K personal health record %K patients %K health services %K medical informatics %K surgery %K orthopedics %K shoulder %K rotator cuff %K rehabilitation %D 2017 %7 07.12.2017 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Translating research into practice, especially the implementation of digital health technologies in routine care, is increasingly important. Yet, there are few studies examining the challenges of implementing patient-facing digital technologies in health care settings. Objective: The aim of this study was to report challenges experienced when implementing mobile apps for patients to support their postsurgical rehabilitation in an orthopedic setting. Methods: A mobile app was tailored to the needs of patients undergoing rotator cuff repair. A 30-min usability session and a 12-week feasibility study were conducted with patients to evaluate the app in routine care. Implementation records (observation reports, issues log, and email correspondence) explored factors that hindered or facilitated patient acceptance. Interviews with clinicians explored factors that influenced app integration in routine care. Results: Participant completion was low (47%, 9/19). Factors that affected patient acceptance included digital literacy, health status, information technology (IT) infrastructure at home, privacy concerns, time limitations, the role of a caregiver, inconsistencies in instruction received from clinicians and the app, and app advice not reflective of patient progress over time. Factors that negatively influenced app integration in routine care included competing demands among clinicians, IT infrastructure in health care settings, identifying the right time to introduce the app to patients, user interface complexity for older patients, lack of coordination among multidisciplinary clinicians, and technical issues with app installation. Conclusions: Three insights were identified for mobile app implementation in routine care: (1) apps for patients need to reflect their journey over time and in particular, postoperative apps ought to be introduced as part of preoperative care with opportunities for patients to learn and adopt the app during their postoperative journey; (2) strategies to address digital literacy issues among patients and clinicians are essential; and (3) impact of the app on patient outcomes and clinician workflow needs to be communicated, monitored, and reviewed. Lastly, digital health interventions should supplement but not replace patient interaction with clinicians. %M 29217504 %R 10.2196/humanfactors.8096 %U http://humanfactors.jmir.org/2017/4/e31/ %U https://doi.org/10.2196/humanfactors.8096 %U http://www.ncbi.nlm.nih.gov/pubmed/29217504 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 4 %N 4 %P e29 %T Enhancing the Usability of an Optical Reader System to Support Point-of-Care Rapid Diagnostic Testing: An Iterative Design Approach %A Hohenstein,Jess %A O'Dell,Dakota %A Murnane,Elizabeth L %A Lu,Zhengda %A Erickson,David %A Gay,Geri %+ Department of Information Science, Cornell University, 343 Campus Rd, Ithaca, NY, 14853, United States, 1 607 254 5347, jch378@cornell.edu %K telemedicine %K point-of-care systems %K self care %K biomedical technology %D 2017 %7 21.11.2017 %9 Original Paper %J JMIR Hum Factors %G English %X Background: In today’s health care environment, increasing costs and inadequate medical resources have created a worldwide need for more affordable diagnostic tools that are also portable, fast, and easy to use. To address this issue, numerous research and commercial efforts have focused on developing rapid diagnostic technologies; however, the efficacy of existing systems has been hindered by usability problems or high production costs, making them infeasible for deployment in at-home, point-of-care (POC), or resource-limited settings. Objective: The aim of this study was to create a low-cost optical reader system that integrates with any smart device and accepts any type of rapid diagnostic test strip to provide fast and accurate data collection, sample analysis, and diagnostic result reporting. Methods: An iterative design methodology was employed by a multidisciplinary research team to engineer three versions of a portable diagnostic testing device that were evaluated for usability and overall user receptivity. Results: Repeated design critiques and usability studies identified a number of system requirements and considerations (eg, software compatibility, biomatter contamination, and physical footprint) that we worked to incrementally incorporate into successive system variants. Our final design phase culminated in the development of Tidbit, a reader that is compatible with any Wi-Fi-enabled device and test strip format. The Tidbit includes various features that support intuitive operation, including a straightforward test strip insertion point, external indicator lights, concealed electronic components, and an asymmetric shape, which inherently signals correct device orientation. Usability testing of the Tidbit indicates high usability for potential user communities. Conclusions: This study presents the design process, specification, and user reception of the Tidbit, an inexpensive, easy-to-use, portable optical reader for fast, accurate quantification of rapid diagnostic test results. Usability testing suggests that the reader is usable among and can benefit a wide group of potential users, including in POC contexts. Generally, the methodology of this study demonstrates the importance of testing these types of systems with potential users and exemplifies how iterative design processes can be employed by multidisciplinary research teams to produce compelling technological solutions. %M 29162559 %R 10.2196/humanfactors.8621 %U http://humanfactors.jmir.org/2017/4/e29/ %U https://doi.org/10.2196/humanfactors.8621 %U http://www.ncbi.nlm.nih.gov/pubmed/29162559 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 9 %P e166 %T Protocol for Usability Testing and Validation of the ISO Draft International Standard 19223 for Lung Ventilators %A Minotra,Dev %A Dain,Steven L %A Burns,Catherine M %+ Department of Systems Design Engineering, University of Waterloo, 200 University Ave. W, Waterloo, ON,, Canada, 1 5198884567 ext 33903, catherine.burns@uwaterloo.ca %K usability %K terminology %K standardization %K lung ventilators %D 2017 %7 08.09.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Clinicians, such as respiratory therapists and physicians, are often required to set up pieces of medical equipment that use inconsistent terminology. Current lung ventilator terminology that is used by different manufacturers contributes to the risk of usage errors, and in turn the risk of ventilator-associated lung injuries and other conditions. Human factors and communication issues are often associated with ventilator-related sentinel events, and inconsistent ventilator terminology compounds these issues. This paper describes our proposed protocol, which will be implemented at the University of Waterloo, Canada when this project is externally funded. Objective: We propose to determine whether a standardized vocabulary improves the ease of use, safety, and utility as it relates to the usability of medical devices, compared to legacy medical devices from multiple manufacturers, which use different terms. Methods: We hypothesize that usage errors by clinicians will be lower when standardization is consistently applied by all manufacturers. The proposed study will experimentally examine the impact of standardized nomenclature on performance declines in the use of an unfamiliar ventilator product in clinically relevant scenarios. Participants will be respiratory therapy practitioners and trainees, and we propose studying approximately 60 participants. Results: The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Conclusions: The proposed study will help us better understand the effects of standardization on medical device usability. The study will also help identify any terms in the International Organization for Standardization (ISO) Draft International Standard (DIS) 19223 that may be associated with recurrent errors. Amendments to the standard will be proposed if recurrent errors are identified. This report contributes a protocol that can be used to assess the effect of standardization in any given domain that involves equipment, multiple manufacturers, inconsistent vocabulary, symbology, audio tones, or patterns in interface navigation. Second, the protocol can be used to experimentally evaluate the ISO DIS 19223 for its effectiveness, as researchers around the world may wish to conduct such tests and compare results. %M 28887292 %R 10.2196/resprot.7298 %U https://www.researchprotocols.org/2017/9/e166/ %U https://doi.org/10.2196/resprot.7298 %U http://www.ncbi.nlm.nih.gov/pubmed/28887292 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 5 %P e85 %T A New Cuffless Device for Measuring Blood Pressure: A Real-Life Validation Study %A Schoot,Tessa S %A Weenk,Mariska %A van de Belt,Tom H %A Engelen,Lucien JLPG %A van Goor,Harry %A Bredie,Sebastian JH %+ Radboud University Medical Center, Department of Internal Medicine and Radboud REshape Innovation Center, Radboud University, PO Box 9101, Nijmegen, 6533 AR, Netherlands, 31 243618819, bas.bredie@radboudumc.nl %K hypertension %K cuffless blood pressure monitor %K wearable device %K cardiovascular risk management %K patient empowerment %D 2016 %7 05.05.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Cuffless blood pressure (BP) monitoring devices, based on pulse transit time, are being developed as an easy-to-use, more convenient, fast, and relatively cheap alternative to conventional BP measuring devices based on cuff occlusion. Thereby they may provide a great alternative to BP self-measurement. Objective: The objective of our study was to evaluate the performance of the first release of the Checkme Health Monitor (Viatom Technology), a cuffless BP monitor, in a real-life setting. Furthermore, we wanted to investigate whether the posture of the volunteer and the position of the device relative to the heart level would influence its outcomes. Methods: Study volunteers fell into 3 BP ranges: high (>160 mmHg), normal (130–160 mmHg), and low (<130 mmHg). All requirements for test environment, observer qualification, volunteer recruitment, and BP measurements were met according to the European Society of Hypertension International Protocol (ESH-IP) for the validation of BP measurement devices. After calibrating the Checkme device, we measured systolic BP with Checkme and a validated, oscillometric reference BP monitor (RM). Measurements were performed in randomized order both in supine and in sitting position, and with Checkme at and above heart level. Results: We recruited 52 volunteers, of whom we excluded 15 (12 due to calibration failure with Checkme, 3 due to a variety of reasons). The remaining 37 volunteers were divided into low (n=14), medium (n=13), and high (n=10) BP ranges. There were 18 men and 19 women, with a mean age of 54.1 (SD 14.5) years, and mean recruitment systolic BP of 141.7 (SD 24.7) mmHg. BP results obtained by RM and Checkme correlated well. In the supine position, the difference between the RM and Checkme was >5 mmHg in 17 of 37 volunteers (46%), of whom 9 of 37 (24%) had a difference >10 mmHg and 5 of 37 (14%) had a difference >15 mmHg. Conclusions: BP obtained with Checkme correlated well with RM BP, particularly in the position (supine) in which the device was calibrated. These preliminary results are promising for conducting further research on cuffless BP measurement in the clinical and outpatient settings. %M 27150527 %R 10.2196/jmir.5414 %U http://www.jmir.org/2016/5/e85/ %U https://doi.org/10.2196/jmir.5414 %U http://www.ncbi.nlm.nih.gov/pubmed/27150527 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 4 %N 2 %P e45 %T Development of a Wearable Cardiac Monitoring System for Behavioral Neurocardiac Training: A Usability Study %A Uddin,Akib A %A Morita,Plinio P %A Tallevi,Kevin %A Armour,Kevin %A Li,John %A Nolan,Robert P %A Cafazzo,Joseph A %+ Centre for Global eHealth Innovation, Techna Institute, University Health Network, TGH/RFE Bldg, 4th Fl., 190 Elizabeth St, Toronto, ON, M5G 2C4, Canada, 1 416 340 4800 ext 4765, akib.uddin@uhn.ca %K mobile health %K smartphones %K sensor devices and platforms %K wireless technology %K mobile applications %K electrocardiography %K biofeedback, psychology %K blood pressure %K stress, physiological %K relaxation %D 2016 %7 22.04.2016 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Elevated blood pressure is one of the main risk factors for death globally. Behavioral neurocardiac training (BNT) is a complementary approach to blood pressure and stress management that is intended to exercise the autonomic reflexes, improve stress recovery, and lower blood pressure. BNT involves cognitive-behavioral therapy with a paced breathing technique and heart rate variability biofeedback. BNT is limited to in-clinic delivery and faces an accessibility barrier because of the need for clinical oversight and the use of complex monitoring tools. Objective: The objective of this project was to design, develop, and evaluate a wearable electrocardiographic (ECG) sensor system for the delivery of BNT in a home setting. Methods: The wearable sensor system, Beat, consists of an ECG sensor and a mobile app. It was developed iteratively using the principles of test-driven Agile development and user-centered design. A usability study was conducted at Toronto General Hospital to evaluate feasibility and user experience and identify areas of improvement. Results: The Beat sensor was designed as a modular patch to be worn on the user’s chest and uses standard ECG electrodes. It streams a single-lead ECG wirelessly to a mobile phone using Bluetooth Low Energy. The use of small, low-power electronics, a low device profile, and a tapered enclosure allowed for a device that can be unobtrusively worn under clothing. The sensor was designed to operate with a mobile app that guides users through the BNT exercises to train them to a slow-paced breathing technique for stress recovery. The BNT app uses the ECG captured by the sensor to provide heart rate variability biofeedback in the form of a real-time heart rate waveform to complement and reinforce the impact of the training. Usability testing (n=6) indicated that the overall response to the design and user experience of the system was perceived positively. All participants indicated that the system had a positive effect on stress management and that they would use it at home. Areas of improvement were identified, which focused primarily on the delivery of training and education on BNT through the app. Conclusions: The outcome of this project was a wearable sensor system to deliver BNT at home. The system has the potential to offer a complementary approach to blood pressure and stress management at home and reduce current accessibility barriers. %M 27106171 %R 10.2196/mhealth.5288 %U http://mhealth.jmir.org/2002/2/e45/ %U https://doi.org/10.2196/mhealth.5288 %U http://www.ncbi.nlm.nih.gov/pubmed/27106171 %0 Journal Article %@ 2292-9495 %I Gunther Eysenbach %V 3 %N 1 %P e1 %T Changes in Default Alarm Settings and Standard In-Service are Insufficient to Improve Alarm Fatigue in an Intensive Care Unit: A Pilot Project %A Sowan,Azizeh Khaled %A Gomez,Tiffany Michelle %A Tarriela,Albert Fajardo %A Reed,Charles Calhoun %A Paper,Bruce Michael %+ Department of Health Restoration and Care Systems Management, School of Nursing, University of Texas Health Science Center at San Antonio, Suite 2.628, 7703 Floyd Curl Dr. - MC 7975, San Antonio, TX, 78229-3900, United States, 1 210 567 5799, sowan@uthscsa.edu %K cardiac monitors %K default alarm settings %K alarm fatigue %K intensive care unit %K nursing %K in-service %K survey %D 2016 %7 11.01.2016 %9 Original Paper %J JMIR Human Factors %G English %X Background: Clinical alarm systems safety is a national concern, specifically in intensive care units (ICUs) where alarm rates are known to be the highest. Interventional projects that examined the effect of changing default alarm settings on overall alarm rate and on clinicians’ attitudes and practices toward clinical alarms and alarm fatigue are scarce. Objective: To examine if (1) a change in default alarm settings of the cardiac monitors and (2) in-service nursing education on cardiac monitor use in an ICU would result in reducing alarm rate and in improving nurses’ attitudes and practices toward clinical alarms. Methods: This quality improvement project took place in a 20-bed transplant/cardiac ICU with a total of 39 nurses. We implemented a unit-wide change of default alarm settings involving 17 parameters of the cardiac monitors. All nurses received an in-service education on monitor use. Alarm data were collected from the audit log of the cardiac monitors 10 weeks before and 10 weeks after the change in monitors’ parameters. Nurses’ attitudes and practices toward clinical alarms were measured using the Healthcare Technology Foundation National Clinical Alarms Survey, pre- and postintervention. Results: Alarm rate was 87.86 alarms/patient day (a total of 64,500 alarms) at the preintervention period compared to 59.18 alarms/patient day (49,319 alarms) postintervention (P=.01). At baseline, Arterial Blood Pressure (ABP), Pair Premature Ventricular Contractions (PVCs), and Peripheral Capillary Oxygen Saturation (SpO2) alarms were the highest. ABP and SpO2 alarms remained among the top three at the postproject period. Out of the 39 ICU nurses, 24 (62%) provided complete pre- and postproject survey questionnaires. Compared to the preintervention survey, no remarkable changes in the postproject period were reported in nurses’ attitudes. Themes in the narrative data were related to poor usability of cardiac monitors and the frequent alarms. The data showed great variation among nurses in terms of changing alarm parameters and frequency of replacing patients' electrodes. Despite the in-service, 50% (12/24) of the nurses specified their need for more training on cardiac monitors in the postproject period. Conclusions: Changing default alarm settings and standard in-service education on cardiac monitor use are insufficient to improve alarm systems safety. Alarm management in ICUs is very complex, involving alarm management practices by clinicians, availability of unit policies and procedures, unit layout, complexity and usability of monitoring devices, and adequacy of training on system use. The complexity of the newer monitoring systems requires urgent usability testing and multidimensional interventions to improve alarm systems safety and to attain the Joint Commission National Patient Safety Goal on alarm systems safety in critical care units. %M 27036170 %R 10.2196/humanfactors.5098 %U http://humanfactors.jmir.org/2016/1/e1/ %U https://doi.org/10.2196/humanfactors.5098 %U http://www.ncbi.nlm.nih.gov/pubmed/27036170 %0 Journal Article %@ 2369-2529 %I JMIR Publications Inc. %V 2 %N 2 %P e10 %T Are Virtual Rehabilitation Technologies Feasible Models to Scale an Evidence-Based Fall Prevention Program? A Pilot Study Using the Kinect Camera %A Shubert,Tiffany E %A Basnett,Jeanna %A Chokshi,Anang %A Barrett,Mark %A Komatireddy,Ravi %+ Shubert Consulting, 1 Coggins Mine Ct, Chapel Hill, NC, North Carolina, United States, 1 919 360 1970, tiffany@shubertconsulting.net %K aging, fall prevention, technology, evidence-based, Kinect, falls %D 2015 %7 05.11.2015 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Falls in older adults are a significant public health issue. Interventions have been developed and proven effective to reduce falls in older adults, but these programs typically last several months and can be resource intensive. Virtual rehabilitation technologies may offer a solution to bring these programs to scale. Off-the-shelf and custom exergames have demonstrated to be a feasible adjunct to rehabilitation with older adults. However, it is not known if older adults will be able or willing to use a virtual rehabilitation technology to participate in an evidence-based fall prevention program. To have the greatest impact, virtual rehabilitation technologies need to be acceptable to older adults from different backgrounds and level of fall risk. If these technologies prove to be a feasible option, they offer a new distribution channel to disseminate fall prevention programs. Objective: Stand Tall (ST) is a virtual translation of the Otago Exercise Program (OEP), an evidence-based fall prevention program. Stand Tall was developed using the Virtual Exercise Rehabilitation Assistant (VERA) software, which uses a Kinect camera and a laptop to deliver physical therapy exercise programs. Our purpose in this pilot study was to explore if ST could be a feasible platform to deliver the OEP to older adults from a variety of fall risk levels, education backgrounds, and self-described level of computer expertise. Methods: Adults age 60 and over were recruited to participate in a one-time usability study. The study included orientation to the program, navigation to exercises, and completion of a series of strength and balance exercises. Quantitative analysis described participants and the user experience. Results: A diverse group of individuals participated in the study. Twenty-one potential participants (14 women, 7 men) met the inclusion criteria. The mean age was 69.2 (± 5.8) years, 38% had a high school education, 24% had a graduate degree, and 66% classified as “at risk for falls”. Eighteen participants agreed they would like to use ST to help improve their balance, and 17 agreed or strongly agreed they would feel confident using the system in either the senior center or the home. Thirteen participants felt confident they could actually set up the system in their home. The mean System Usability Scale (SUS) score was 65.5 ± 21.2 with a range of 32.5 to 97.5. Ten participants scored ST as an above average usability experience compared to other technologies and 5 participants scored a less than optimal experience. Exploratory analysis revealed no significant relationships between user experience, education background, self-described computer experience, and fall risk. Conclusions: Results support the virtual delivery of the OEP by a Kinect camera and an avatar may be acceptable to older adults from a variety of backgrounds. Virtual technologies, like Stand Tall, could offer an efficient and effective approach to bring evidence-based fall prevention programs to scale to address the problem of falls and fall-related injuries. Next steps include determining if similar or better outcomes are achieved by older adults using the virtual OEP, Stand Tall, compared to the standard of care. %M 28582244 %R 10.2196/rehab.4776 %U http://rehab.jmir.org/2015/2/e10/ %U https://doi.org/10.2196/rehab.4776 %U http://www.ncbi.nlm.nih.gov/pubmed/28582244 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 8 %P e202 %T “You Get Reminded You’re a Sick Person”: Personal Data Tracking and Patients With Multiple Chronic Conditions %A Ancker,Jessica S %A Witteman,Holly O %A Hafeez,Baria %A Provencher,Thierry %A Van de Graaf,Mary %A Wei,Esther %+ Weill Cornell Medical College, Department of Healthcare Policy and Research, Division of Health Informatics, 425 E. 61st St., Suite 301, New York, NY, 10065, United States, 1 646 962 9404, jsa7002@med.cornell.edu %K medical informatics %K consumer health information %K health knowledge, attitudes, practices %K self-care %K chronic disease %D 2015 %7 19.08.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Consumer health information technologies (HIT) that encourage self-tracking, such as diet and fitness tracking apps and disease journals, are attracting widespread interest among technology-oriented consumers (such as “quantified self” advocates), entrepreneurs, and the health care industry. Such electronic technologies could potentially benefit the growing population of patients with multiple chronic conditions (MCC). However, MCC is predominantly a condition of the elderly and disproportionately affects the less affluent, so it also seems possible that the barriers to use of consumer HIT would be particularly severe for this patient population. Objective: Our aim was to explore the perspectives of individuals with MCC using a semistructured interview study. Our research questions were (1) How do individuals with MCC track their own health and medical data? and (2) How do patients and providers perceive and use patient-tracked data? Methods: We used semistructured interviews with patients with multiple chronic diseases and providers with experience caring for such patients, as well as participation in a diabetes education group to triangulate emerging themes. Data were analyzed using grounded theory and thematic analysis. Recruitment and analysis took place iteratively until thematic saturation was reached. Results: Interviews were conducted with 22 patients and 7 health care providers. The patients had an average of 3.5 chronic conditions, including type 2 diabetes, heart disease, chronic pain, and depression, and had regular relationships with an average of 5 providers. Four major themes arose from the interviews: (1) tracking this data feels like work for many patients, (2) personal medical data for individuals with chronic conditions are not simply objective facts, but instead provoke strong positive and negative emotions, value judgments, and diverse interpretations, (3) patients track for different purposes, ranging from sense-making to self-management to reporting to the doctor, and (4) patients often notice that physicians trust technologically measured data such as lab reports over patients’ self-tracked data. Conclusions: Developers of consumer health information technologies for data tracking (such as diet and exercise apps or blood glucose logs) often assume patients have unlimited enthusiasm for tracking their own health data via technology. However, our findings potentially explain relatively low adoption of consumer HIT, as they suggest that patients with multiple chronic illnesses consider it work to track their own data, that the data can be emotionally charged, and that they may perceive that providers do not welcome it. Similar themes have been found in some individual chronic diseases but appeared more complex because patients often encountered “illness work” connected to multiple diseases simultaneously and frequently faced additional challenges from aging or difficult comorbidities such as chronic pain, depression, and anxiety. We suggest that to make a public health impact, consumer HIT developers should engage creatively with these pragmatic and emotional issues to reach an audience that is broader than technologically sophisticated early adopters. Novel technologies are likely to be successful only if they clearly reduce patient inconvenience and burden, helping them to accomplish their “illness work” more efficiently and effectively. %M 26290186 %R 10.2196/jmir.4209 %U http://www.jmir.org/2015/8/e202/ %U https://doi.org/10.2196/jmir.4209 %U http://www.ncbi.nlm.nih.gov/pubmed/26290186 %0 Journal Article %@ 2292-9495 %I Gunther Eysenbach %V 2 %N 1 %P e11 %T Usability and Acceptability of ASSESS MS: Assessment of Motor Dysfunction in Multiple Sclerosis Using Depth-Sensing Computer Vision %A Morrison,Cecily %A D'Souza,Marcus %A Huckvale,Kit %A Dorn,Jonas F %A Burggraaff,Jessica %A Kamm,Christian Philipp %A Steinheimer,Saskia Marie %A Kontschieder,Peter %A Criminisi,Antonio %A Uitdehaag,Bernard %A Dahlke,Frank %A Kappos,Ludwig %A Sellen,Abigail %+ Microsoft Research, Human Experience & Design, 21 Station Road, Cambridge, , United Kingdom, 44 1223 479951, cecilym@microsoft.com %K depth-sensing computer vision %K information interfaces and presentation %K Kinect %K motor skills %K multiple sclerosis %K rehabilitation %D 2015 %7 24.06.2015 %9 Original Paper %J JMIR Human Factors %G English %X Background: Sensor-based recordings of human movements are becoming increasingly important for the assessment of motor symptoms in neurological disorders beyond rehabilitative purposes. ASSESS MS is a movement recording and analysis system being developed to automate the classification of motor dysfunction in patients with multiple sclerosis (MS) using depth-sensing computer vision. It aims to provide a more consistent and finer-grained measurement of motor dysfunction than currently possible. Objective: To test the usability and acceptability of ASSESS MS with health professionals and patients with MS. Methods: A prospective, mixed-methods study was carried out at 3 centers. After a 1-hour training session, a convenience sample of 12 health professionals (6 neurologists and 6 nurses) used ASSESS MS to capture recordings of standardized movements performed by 51 volunteer patients. Metrics for effectiveness, efficiency, and acceptability were defined and used to analyze data captured by ASSESS MS, video recordings of each examination, feedback questionnaires, and follow-up interviews. Results: All health professionals were able to complete recordings using ASSESS MS, achieving high levels of standardization on 3 of 4 metrics (movement performance, lateral positioning, and clear camera view but not distance positioning). Results were unaffected by patients’ level of physical or cognitive disability. ASSESS MS was perceived as easy to use by both patients and health professionals with high scores on the Likert-scale questions and positive interview commentary. ASSESS MS was highly acceptable to patients on all dimensions considered, including attitudes to future use, interaction (with health professionals), and overall perceptions of ASSESS MS. Health professionals also accepted ASSESS MS, but with greater ambivalence arising from the need to alter patient interaction styles. There was little variation in results across participating centers, and no differences between neurologists and nurses. Conclusions: In typical clinical settings, ASSESS MS is usable and acceptable to both patients and health professionals, generating data of a quality suitable for clinical analysis. An iterative design process appears to have been successful in accounting for factors that permit ASSESS MS to be used by a range of health professionals in new settings with minimal training. The study shows the potential of shifting ubiquitous sensing technologies from research into the clinic through a design approach that gives appropriate attention to the clinic environment. %M 27025782 %R 10.2196/humanfactors.4129 %U http://humanfactors.jmir.org/2015/1/e11/ %U https://doi.org/10.2196/humanfactors.4129 %U http://www.ncbi.nlm.nih.gov/pubmed/27025782 %0 Journal Article %@ 2292-9495 %I Gunther Eysenbach %V 2 %N 1 %P e3 %T Nurses' Perceptions and Practices Toward Clinical Alarms in a Transplant Cardiac Intensive Care Unit: Exploring Key Issues Leading to Alarm Fatigue %A Sowan,Azizeh Khaled %A Tarriela,Albert Fajardo %A Gomez,Tiffany Michelle %A Reed,Charles Calhoun %A Rapp,Kami Marie %+ University of Texas Health Science Center at San Antonio, School of Nursing, Department of Health Restoration and Care Systems Management, School of Nursing, 7703 Floyd Curl Dr. - MC 7975, San Antonio, TX, 78229-3900, United States, 1 210 567 5799, sowan@uthscsa.edu %K clinical alarms %K alarm fatigue %K critical care %K physiologic monitors %K nursing %K survey %D 2015 %7 16.03.2015 %9 Original Paper %J JMIR Human Factors %G English %X Background: Intensive care units (ICUs) are complex work environments where false alarms occur more frequently than on non-critical care units. The Joint Commission National Patient Safety Goal .06.01.01 targeted improving the safety of clinical alarm systems and required health care facilities to establish alarm systems safety as a hospital priority by July 2014. An important initial step toward this requirement is identifying ICU nurses’ perceptions and common clinical practices toward clinical alarms, where little information is available. Objective: Our aim was to determine perceptions and practices of transplant/cardiac ICU (TCICU) nurses toward clinical alarms and benchmark the results against the 2011 Healthcare Technology Foundation’s (HTF) Clinical Alarms Committee Survey. Methods: A quality improvement project was conducted on a 20-bed TCICU with 39 full- and part-time nurses. Nurses were surveyed about their perceptions and attitudes toward and practices on clinical alarms using an adapted HTF clinical alarms survey. Results were compared to the 2011 HTF data. Correlations among variables were examined. Results: All TCICU nurses provided usable responses (N=39, 100%). Almost all nurses (95%-98%) believed that false alarms are frequent, disrupt care, and reduce trust in alarm systems, causing nurses to inappropriately disable them. Unlike the 2011 HTF clinical alarms survey results, a significantly higher percentage of our TCICU nurses believed that existing devices are complex, questioned the ability and adequacy of the new monitoring systems to solve alarm management issues, pointed to the lack of prompt response to alarms, and indicated the lack of clinical policy on alarm management (P<.01). Major themes in the narrative data focused on nurses’ frustration related to the excessive number of alarms and poor usability of the cardiac monitors. A lack of standardized approaches exists in changing patients’ electrodes and individualizing parameters. Around 60% of nurses indicated they received insufficient training on bedside and central cardiac monitors. A correlation also showed the need for training on cardiac monitors, specifically for older nurses (P=.01). Conclusions: False and non-actionable alarms continue to desensitize TCICU nurses, perhaps resulting in missing fatal alarms. Nurses’ attitudes and practices related to clinical alarms are key elements for designing contextually sensitive quality initiatives to fight alarm fatigue. Alarm management in ICUs is a multidimensional complex process involving usability of monitoring devices, and unit, clinicians, training, and policy-related factors. This indicates the need for a multi-method approach to decrease alarm fatigue and improve alarm systems safety. %M 27025940 %R 10.2196/humanfactors.4196 %U http://humanfactors.jmir.org/2015/1/e3/ %U https://doi.org/10.2196/humanfactors.4196 %U http://www.ncbi.nlm.nih.gov/pubmed/27025940