Detectability of use errors in summative usability tests of medical devices: Impact of the test environment.

The regulations on summative usability evaluations of medical devices (MDs) emphasize that the test environment must have sufficient ecological validity for generalization to real-life use. Here, we examined the influence of environmental fidelity (a component of ecological validity) on the detectability of MD use errors. A total of 140 participants participated in a summative usability evaluation of an anaphylactic shock auto-injector device under either a high-fidelity condition or a condition acceptable from the manufacturer's perspective, lower-fidelity condition. The numbers of errors detected in each condition were compared by applying descriptive statistics and logistic and Poisson multivariate regressions. We found that the level of fidelity did not influence the overall number of use errors detected but did influence the detection of certain use errors. To optimize the test environment and increase the detection of use errors, each environmental feature's role in the test task should first be examined.

Use of a Semiautomatic Text Message System to Improve Satisfaction With Wait Time in the Adult Emergency Department: Cross-sectional Survey Study.

BACKGROUND: Many factors influence patient satisfaction during an emergency department (ED) visit, but the perception of wait time plays a central role. A long wait time in the waiting room increases the risk of hospital-acquired infection, as well as the risk of a patient leaving before being seen by a physician, particularly those with a lower level of urgency who may have to wait for a longer time. OBJECTIVE: We aimed to improve the perception of wait time through the implementation of a semiautomatic SMS text message system that allows patients to wait outside the hospital and facilitates the recall of patients closer to the scheduled time of meeting with the physician. METHODS: We performed a cross-sectional survey to evaluate the system using a tailored questionnaire to assess the patient perspective and the Unified Theory of Acceptance and Use of Technology questionnaire for the caregiver perspective. We also monitored the frequency of system use with logs. RESULTS: A total of 110 usable responses were collected (100 patients and 10 caregivers). Findings revealed that 97 of 100 (97%) patients were satisfied, with most patients waiting outside the ED but inside the hospital. The caregiver evaluation showed that it was very easy to use, but the adoption of the system was more problematic because of the perceived additional workload associated with its use. CONCLUSIONS: Although not suitable for all patients, our system allows those who have a low-severity condition to wait outside the waiting room and to be recalled according to the dedicated time defined in the Swiss Emergency Triage Scale. It not only has the potential to reduce the risk of hospital-acquired infection but also can enhance the patient experience; additionally, it was perceived as a real improvement. Further automation of the system needs to be explored to reduce caregiver workload and increase its use.

A National Survey Comparing Patients' and Transplant Professionals' Research Priorities in the Swiss Transplant Cohort Study.

We aimed to identify, assess, compare and map research priorities of patients and professionals in the Swiss Transplant Cohort Study. The project followed 3 steps. 1) Focus group interviews identified patients' (n = 22) research priorities. 2) A nationwide survey assessed and compared the priorities in 292 patients and 175 professionals. 3) Priorities were mapped to the 4 levels of Bronfenbrenner's ecological framework. The 13 research priorities (financial pressure, medication taking, continuity of care, emotional well-being, return to work, trustful relationships, person-centredness, organization of care, exercise and physical fitness, graft functioning, pregnancy, peer contact and public knowledge of transplantation), addressed all framework levels: patient (n = 7), micro (n = 3), meso (n = 2), and macro (n = 1). Comparing each group's top 10 priorities revealed that continuity of care received highest importance rating from both (92.2% patients, 92.5% professionals), with 3 more agreements between the groups. Otherwise, perspectives were more diverse than congruent: Patients emphasized patient level priorities (emotional well-being, graft functioning, return to work), professionals those on the meso level (continuity of care, organization of care). Patients' research priorities highlighted a need to expand research to the micro, meso and macro level. Discrepancies should be recognized to avoid understudying topics that are more important to professionals than to patients.

Usability Testing of a Patient-Centered Mobile Health App for Supporting and Guiding the Pediatric Emergency Department Patient Journey: Mixed Methods Study.

BACKGROUND: Patient experience in emergency departments (EDs) remains often suboptimal and can be a source of stress, particularly in pediatric settings. In an attempt to support patients and their families before, during, and after their visit to a pediatric ED, a mobile health (mHealth) app was developed by a multidisciplinary team based on patient-centered care principles. OBJECTIVE: This study aims to evaluate the usability (effectiveness, efficiency, and satisfaction) of a new mHealth app, InfoKids, by potential end users through usability testing. METHODS: The app was assessed through an in-laboratory, video-recorded evaluation in which participants had to execute 9 goal-oriented tasks, ranging from account creation to the reception of a diagnostic sheet at the end of the emergency care episode. Effectiveness was measured based on the task completion rate, efficiency on time on task, and user satisfaction according to answers to the System Usability Scale questionnaire. Think-aloud usability sessions were also transcribed and analyzed. Usability problems were rated for their severity and categorized according to ergonomic criteria. RESULTS: A total of 17 parents participated in the study. The overall completion rate was 97.4% (149/153). Overall, they reported good effectiveness, with the task successfully completed in 88.2% (135/153) of cases (95% CI 83%-93%). Each task, with the exception of the first, created difficulties for some participants but did not prevent their completion by most participants. Users reported an overall good to excellent perceived usability of the app. However, ergonomic evaluation identified 14 usability problems occurring 81 time. Among these, 50% (7/14) were serious as their severity was rated as either major or catastrophic and indicated areas of improvements for the app. Following the suggested usability improvements by participants, mitigation measures were listed to further improve the app and avoid barriers to its adoption. CONCLUSIONS: Usability of the InfoKids app was evaluated as good to excellent by users. Areas of improvement were identified, and mitigation measures were proposed to inform its development toward a universal app for all ED patients visiting a digitalized institution. Its contribution could also be useful in paving the way for further research on mobile apps aimed at supporting and accompanying patients in their care episodes, as research in this area is scarce.

Applying the FAIR4Health Solution to Identify Multimorbidity Patterns and Their Association with Mortality through a Frequent Pattern Growth Association Algorithm.

The current availability of electronic health records represents an excellent research opportunity on multimorbidity, one of the most relevant public health problems nowadays. However, it also poses a methodological challenge due to the current lack of tools to access, harmonize and reuse research datasets. In FAIR4Health, a European Horizon 2020 project, a workflow to implement the FAIR (findability, accessibility, interoperability and reusability) principles on health datasets was developed, as well as two tools aimed at facilitating the transformation of raw datasets into FAIR ones and the preservation of data privacy. As part of this project, we conducted a multicentric retrospective observational study to apply the aforementioned FAIR implementation workflow and tools to five European health datasets for research on multimorbidity. We applied a federated frequent pattern growth association algorithm to identify the most frequent combinations of chronic diseases and their association with mortality risk. We identified several multimorbidity patterns clinically plausible and consistent with the bibliography, some of which were strongly associated with mortality. Our results show the usefulness of the solution developed in FAIR4Health to overcome the difficulties in data management and highlight the importance of implementing a FAIR data policy to accelerate responsible health research.

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

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

FAIR4Health: Findable, Accessible, Interoperable and Reusable data to foster Health Research.

Due to the nature of health data, its sharing and reuse for research are limited by ethical, legal and technical barriers. The FAIR4Health project facilitated and promoted the application of FAIR principles in health research data, derived from the publicly funded health research initiatives to make them Findable, Accessible, Interoperable, and Reusable (FAIR). To confirm the feasibility of the FAIR4Health solution, we performed two pathfinder case studies to carry out federated machine learning algorithms on FAIRified datasets from five health research organizations. The case studies demonstrated the potential impact of the developed FAIR4Health solution on health outcomes and social care research. Finally, we promoted the FAIRified data to share and reuse in the European Union Health Research community, defining an effective EU-wide strategy for the use of FAIR principles in health research and preparing the ground for a roadmap for health research institutions. This scientific report presents a general overview of the FAIR4Health solution: from the FAIRification workflow design to translate raw data/metadata to FAIR data/metadata in the health research domain to the FAIR4Health demonstrators' performance.

Designing an eHealth Coaching Solution to Improve Transitional Care of Seniors' with Heart Failure: End-User Needs.

Based on scientific studies, heart failure is the principal cause of hospitalization among seniors. More than 50% of elderly with heart failure are readmitted to hospital within six months. Readmission is linked with poor compliance with medical treatment and recommendations, emphasizing the need for a tool to help seniors better comply with post-discharge measures. The goal of this study was to identify end-user needs for the development of a coaching solution aiming to support elderly patients but also formal and informal caregivers. End-user needs were identified through interviews with the three end-user profiles: seniors with heart failure and formal and informal caregivers. The results present six categories of needs: daily treatment follow-up; healthcare network communication; transfer of information; synchronization with current digital tools; information access; and psychosocial support. The identified needs will help to develop an eHealth solution to improve care management and coaching after discharge.

[Mobile applications and self-management of chronic pain]. / Applications mobiles et autogestion des douleurs chroniques.

Self-management of chronic pain should enable patients to regain an acceptable quality of life, autonomy, and reduce the number of consultations. These strategies are increasingly available on mobile applications, which have been evaluated for their content and effectiveness in several reviews. The vast majority of applications offer only one self-management strategy, few opportunities for interactions, and have not involved patients and healthcare professionals in their development. It is therefore still difficult to determine their effectiveness in the self-management of chronic pain. However, mobile applications should not be neglected. On the contrary, it is necessary to develop validated applications in French considering the five criteria classically recommended for self-management. Then such applications can be prescribed by health professionals as part of the multimodal management of chronic pain.

L'autogestion des douleurs chroniques doit permettre aux patients de retrouver une qualité de vie acceptable, une autonomie, et de diminuer les consultations. Ces stratégies sont de plus en plus disponibles sur des applications mobiles dont plusieurs revues ont évalué le contenu et l'efficacité. Il en ressort que la grande majorité des applications ne proposent qu'une seule stratégie d'autogestion, offrent peu de possibilités d'interactions, et n'ont pas impliqué dans leur développement patients ou professionnels de la santé. Il est ainsi encore difficile de déterminer leur efficacité dans l'autogestion des douleurs chroniques. Cependant, les applications mobiles ne sont pas un moyen à négliger, il faut au contraire développer des applications validées en français tenant compte des cinq critères classiquement recommandés pour l'autogestion. Alors de telles applications pourront être prescrites par les professionnels de la santé dans le cadre de la prise en charge multimodale des douleurs chroniques.

Mixed and Augmented Reality Tools in the Medical Anatomy Curriculum.

The use of augmented reality (AR) in the medical field has grown since 2007-2013 and was first introduced in surgical departments. AR and mixed reality (MR) allow us to explore complex structures, observe phenomena that are difficult or impossible to see otherwise, and interact with the virtual structures they display. Recently, they are beginning to be adopted for education. This work examines whether new AR and MR technological tools, when used in the context of anatomical teaching, can allow for strengthening of teaching quality - for example by overcoming new or existing constraints such as the limited availability of dissection specimen. This work also considers how these technologies are to be applied efficiently and practically in teaching. An attempt is made to answer these questions in three stages: i) a non-systematic review of the literature ii) a review of augmented reality solutions for anatomy available on four different platforms iii) a 30-person study of the usability of augmented reality. The results show that there is potential for AR and MR to supplement anatomical teaching, but that traditional methods remain indispensable.

User Expectations and Willingness to Share Self-Collected Health Data.

The rapid improvement in mobile health technologies revolutionized what and how people can self-record and manage data. This massive amount of information accumulated by these technologies has potentially many applications beyond personal need, i.e. for public health. A challenge with collecting this data is to motivate people to share this data for the benefit of all. The purpose of this study is to survey and examine factors that may motivate sharing this data. We asked 447 participants four questions related to health data sharing and motivation. Participants with a chronic disease were concerned about data sharing but also willing to share health data if personalized feedback is provided. Functionality, ease of use, and privacy are regarded as crucial features of health apps.

User-Centred Approach to Design an Online Social Support Platform for Seniors : Identification of Users' Types and Their Requirements.

A well-designed social platform has the potential to reduce senior isolation and promote active ageing. However, to design tools that respond to the user need it is important to understand what types of seniors will use it and what are their needs. Through a user-oriented approach at several design stage: focus group, co-creation and usability test we were able to identify the different roles related to the use of the platform, which allowed us to classify them by type, each type having very specific needs. Among the types of users identified, "Active users" are looking for an efficient platform. "Socialiser users" are more passive and mainly interested to participate in activities and are sensitive to trust. "Low skilled users" have limited digital skills and must be accompanied to start with the platform. Finally, "Sporadic users" lack of time to actively use the platform but would use a platform involving a large number of stakeholders. It is important to include all these different types of users in the design phase to ensure the future success of the social platform.

Citizens' Participation in Health and Scientific Research in Switzerland.

Understanding motivation and resistance factors affecting citizen participation in health and scientific research allows to find solutions to improve citizen engagement and interest in science. Through a survey, we identified the main factors influencing citizens' participation in scientific research, and their wishes to be more informed. Results show that the respondents' reasons to participate in research were altruistic motivations, in line with other studies carried out in developed countries. The main factor influencing the non-participation is the lack of opportunity, highlighting the importance to better inform citizens about ongoing studies.

Preliminary Evaluation of a mHealth Coaching Conversational Artificial Intelligence for the Self-Care Management of People with Sickle-Cell Disease.

Adherence to the complex set of recommended self-care practices among people with Sickle-Cell Disease (SCD) positively impacts health outcomes. However, few patients possess the required skills (i.e. disease-specific knowledge, adequate levels of self-efficacy). Consequently, adherence rates remain low and only 1% of patients are empowered enough to master the self-care practices. Health coaching and therapeutic patient education have emerged as new approaches to enhance patients' self-management and support health behavior changes. This preliminary feasibility study examined patients' perceived usefulness of the information provided by a chatbot we developed following patient-important requirements collected during our preliminary studies. Participants tested the chatbot and completed a post-test survey. A total of 19 patients were enrolled and 2 withdrew. 15 respondents (15/17, 88%) gave a score of at least 3/4 to the question "The chatbot contains all the information I need". Results suggest that mHealth coaching apps could be used to promote the knowledge acquisition of recommended health behaviors related to the prevention of SCD main symptoms.

Factors Influencing Motivation and Engagement in Mobile Health Among Patients With Sickle Cell Disease in Low-Prevalence, High-Income Countries: Qualitative Exploration of Patient Requirements.

BACKGROUND: Sickle cell disease (SCD) is a hematological genetic disease affecting over 25 million people worldwide. The main clinical manifestations of SCD, hemolytic anemia and vaso-occlusion, lead to chronic pain and organ damages. With recent advances in childhood care, high-income countries have seen SCD drift from a disease of early childhood mortality to a neglected chronic disease of adulthood. In particular, coordinated, preventive, and comprehensive care for adults with SCD is largely underresourced. Consequently, patients are left to self-manage. Mobile health (mHealth) apps for chronic disease self-management are now flooding app stores. However, evidence remains unclear about their effectiveness, and the literature indicates low user engagement and poor adoption rates. Finally, few apps have been developed for people with SCD and none encompasses their numerous and complex self-care management needs. OBJECTIVE: This study aimed to identify factors that may influence the long-term engagement and user adoption of mHealth among the particularly isolated community of adult patients with SCD living in low-prevalence, high-income countries. METHODS: Semistructured interviews were conducted. Interviews were audiotaped, transcribed verbatim, and analyzed using thematic analysis. Analysis was informed by the Braun and Clarke framework and mapped to the COM-B model (capability, opportunity, motivation, and behavior). Results were classified into high-level functional requirements (FRs) and nonfunctional requirements (NFRs) to guide the development of future mHealth interventions. RESULTS: Overall, 6 males and 4 females were interviewed (aged between 21 and 55 years). Thirty FRs and 31 NFRs were extracted from the analysis. Most participants (8/10) were concerned about increasing their physical capabilities being able to stop pain symptoms quickly. Regarding the psychological capability aspects, all interviewees desired to receive trustworthy feedback on their self-care management practices. About their physical opportunities, most (7/10) expressed a strong desire to receive alerts when they would reach their own physiological limitations (ie, during physical activity). Concerning social opportunity, most (9/10) reported wanting to learn about the self-care practices of other patients. Relating to motivational aspects, many interviewees (6/10) stressed their need to learn how to avoid the symptoms and live as normal a life as possible. Finally, NFRs included inconspicuousness and customizability of user experience, automatic data collection, data shareability, and data privacy. CONCLUSIONS: Our findings suggest that motivation and engagement with mHealth technologies among the studied population could be increased by providing features that clearly benefit them. Self-management support and self-care decision aid are patients' major demands. As the complexity of SCD self-management requires a high cognitive load, pervasive health technologies such as wearable sensors, implantable devices, or inconspicuous conversational user interfaces should be explored to ease it. Some of the required technologies already exist but must be integrated, bundled, adapted, or improved to meet the specific needs of people with SCD.

Patients' time perception in the waiting room of an ambulatory emergency unit: a cross-sectional study.

BACKGROUND: Patient satisfaction has become an increasingly important element in a service-oriented healthcare market. Although satisfaction is influenced by many factors, the waiting time to be seen by medical staff has been shown to be one of the key criteria. However, waiting is not an objective experience and several factors can influence its perception. METHODS: We conducted a questionnaire-based, cross-sectional study among patients attending the emergency unit of a Swiss university hospital in order to explore the key factors influencing wait perception. RESULTS: A total of 509 patients participated in the study. Appropriate assessment of emergency level by caregivers, the feeling of being forgotten, respect of privacy, and lack of information on the exact waiting time were identified as significant variables for wait perception. CONCLUSIONS: Our study confirmed the existence of a 'golden hour' when the patient is willing to wait until the medical encounter. In case the wait cannot be limited, an appropriate assessment of the emergency level by caregivers and avoiding the patients of feeling being forgotten are very important factors to avoid a negative perception of the waiting time before seeing a doctor. TRIAL REGISTRATION: (ID REQ-2016-00555).

[InfoKids: changing the patients' journey paradigm in an Emergency Department]. / InfoKids : changement de paradigme du parcours patients dans un service d'urgences.

Nowadays, citizens are little supported to decide whether they should consult the Emergency Departments (ED) in case of illness or trauma. Moreover, once in the ED, they often must deal with overcrowding, long waiting times, the acute nature of the visits, administrative data management, and a lack of follow-up after the visit. To improve this situation, we have developed an e-health solution delivering a more patient-centered experience by connecting patients, caregivers, and administrative clerks through a web and mobile applications. This innovative system is intended to improve the entire emergency care process, facilitating the caregiver and administrative work and supporting patients before, during, and after their ED consultation.

De nos jours, les citoyens sont peu soutenus en cas de maladie ou de traumatisme pour décider si leur état de santé justifie une consultation aux urgences. Arrivés aux urgences, les patients doivent faire face à des délais d'attente, au stress engendré par une urgence médicale et au manque d'information concernant le suivi à domicile. Afin d'améliorer cette situation, nous avons développé une solution d'e-santé, composée d'applications web et mobiles, guidant le patient de manière personnalisée tout au long de son parcours et connectant patients, soignants et employés administratifs. Ce système novateur améliore l'ensemble du processus de soins d'urgence en facilitant le travail des soignants, des administratifs et en soutenant les patients avant, pendant et après leurs consultations aux urgences.

Designing an Online Social Support Platform Through Co-Creation with Seniors.

The high number of seniors that feels excluded of society highlights the necessity to promote active ageing. This intention can be supported through online platforms that encourage participation in social activities. The goal of the present study was to identify design principles of online support platforms for seniors through focus groups and to ideate the platform through co-creation sessions. The results show that a social platform for seniors must, among other, help to foster contact between users, and must provide services and meaningful activities. A first mock-up of the platform's design has been created based on the co-creation sessions and will be iteratively evaluated and enhanced in future studies in four countries across Europe. Our findings are in line with those of other studies demonstrating that seniors attach importance to trustworthiness and need to maintain social ties.

Connecting Parents to a Pediatric Emergency Department: Designing a Mobile App Based on Patient Centred Care Principles.

INTRODUCTION: Patient centred care fosters a holistic approach of care switching the focus from a disease perspective to a patient's experience perspective. Patient centred care is of particular importance in the context of paediatric emergency medicine. Indeed, parents entering a paediatric emergency department (PED) are usually under stress caused by their children's illness, the unfamiliar setting of the PED and delays of care. All these factors can deteriorate their experience as well as the relationships between healthcare providers, the patients and their parents. METHODS: We explore potential areas to improve the patient experience during his journey into PED. The dimensions of the picker's patient centred care are used to guide observations, conduct interviews and focus groups. The areas of improvement are then operationalized through their translation into app functionalities. RESULTS: Our novel application allows supporting users on 7 of the 8 dimensions of picker's patient centred care model. The app supports parents in their decision-making to consult a PED, it provides relevant medical information to avoid unrealistic expectations and accompany the family after discharge thanks to tailored information sheets about diagnostics. CONCLUSION: Our mobile app allows to make a big step toward the improvement of the patient-caregiver relationship. The direct benefits will be shared by patients and caregivers, as well as the institution.

Communication of Children Symptoms in Emergency: Classification of the Terminology.

The significant part of non-urgent visits to the emergency highlight the necessity to advise people on the actions to take according to their symptoms. Although information sources are accessible through different channels their content often employs medical terminologies that are difficult to understand by laypersons. Our goal is to provide a terminology of the most common symptoms in pediatric emergency adapted to laypersons. This terminology is organized in a hierarchy by the mean of a card-sorting study. The resulting classification separates the symptoms into two main categories: "accident" and "illness" that are subdivided in 9 and 10 sub-categories. The study also revealed that some symptoms were not understood by the participants and had to be reformulated, confirming the importance of user-centered method. The classification resulting from this study will be evaluated through a tree-test.