Medical device regulation: requirements for occupational therapists in The Netherlands who prescribe and manufacture custom-made devices.

PURPOSE: To interpret the Medical Device Regulation for occupational therapists in the Netherlands involved in prescribing and manufacturing custom-made assistive devices and to develop a roadmap for implementation. MATERIALS AND METHODS: Four online iterative co-design workshops were organized under supervision of a senior quality manager to assist in the interpretation of the MDR framework with a focus on custom-made assistive devices; and to assist the implementation by generating guidelines and forms. The workshops for seven participating occupational therapists had an interactive character with Q&A, small and homework assignments, and oral evaluations. Next to occupational therapists, participants with different backgrounds joined such as 3D printing experts, engineers, managers, and researchers. RESULTS: The participants experienced the interpretation of the MDR as informative, but also as complex . Complying with the MDR requires considerable documentation activities that are currently not part of care professionals tasks. This initially raised concerns regarding implementation in daily practice. To facilitate the MDR implementation, forms were created and evaluated for a selected design case together with the participants for future reference. Additionally, instructions were given which forms should be filled out only once per organization, which forms could be reused for similar types of custom-made devices, and which forms should be filled out for each individual custom-made device. CONCLUSIONS: This study provides practical guidelines and forms to support occupational therapists in the Netherlands to prescribe and manufacture custom-made medical devices complying with the MDR. It is recommended to involve engineers and/or quality managers in this process.IMPLICATIONS FOR REHABILITATIONOccupational therapists are considered legal manufacturer when they prescribe and manufacture custom-made medical devices for their clients. As such they are legally obliged to meet the Medical Device Regulation (MDR).When designing and manufacturing "in-house" custom-made medical devices, care organizations need to follow and document activities to demonstrate compliance with the MDR. This study offers practical guidelines and forms to facilitate this.

Acceptance of 3D Printing by Occupational Therapists: An Exploratory Survey Study.

Do-it-yourself (DiY) assistive technology gained attention in accessibility literature recently, especially in relation to the rise of digital fabrication technologies, such as 3D printing. Previously, small-scale studies showed that care professionals generally respond positively towards the idea of creating DiY assistive devices for their clients. However, several barriers and concerns may hinder care professionals' actual adoption of digital fabrication technologies. To better understand occupational therapists' willingness to adopt 3D printing, we have conducted an exploratory survey study (N = 119) based on the unified theory of acceptance and use of technology (UTAUT). Confirming previous studies, occupational therapists in this study showed generally positive attitudes towards adopting 3D printing technology. Factors that may affect their intentions to use 3D printing technology include expectations regarding job performance, effort, social influence, and facilitating conditions, as well as one's tendency to adopt novel technologies. Furthermore, occupational therapists will likely experience difficulties when first using 3D printing technology, despite their overall positive expectations of the ease of use. Therefore, we recommend that further research should focus on training, but especially on effective ways to support occupational therapists on the job, for instance, by facilitating collaborations with 3D printing experts.

A Personal Health System for Self-Management of Congestive Heart Failure (HeartMan): Development, Technical Evaluation, and Proof-of-Concept Randomized Controlled Trial.

BACKGROUND: Congestive heart failure (CHF) is a disease that requires complex management involving multiple medications, exercise, and lifestyle changes. It mainly affects older patients with depression and anxiety, who commonly find management difficult. Existing mobile apps supporting the self-management of CHF have limited features and are inadequately validated. OBJECTIVE: The HeartMan project aims to develop a personal health system that would comprehensively address CHF self-management by using sensing devices and artificial intelligence methods. This paper presents the design of the system and reports on the accuracy of its patient-monitoring methods, overall effectiveness, and patient perceptions. METHODS: A mobile app was developed as the core of the HeartMan system, and the app was connected to a custom wristband and cloud services. The system features machine learning methods for patient monitoring: continuous blood pressure (BP) estimation, physical activity monitoring, and psychological profile recognition. These methods feed a decision support system that provides recommendations on physical health and psychological support. The system was designed using a human-centered methodology involving the patients throughout development. It was evaluated in a proof-of-concept trial with 56 patients. RESULTS: Fairly high accuracy of the patient-monitoring methods was observed. The mean absolute error of BP estimation was 9.0 mm Hg for systolic BP and 7.0 mm Hg for diastolic BP. The accuracy of psychological profile detection was 88.6%. The F-measure for physical activity recognition was 71%. The proof-of-concept clinical trial in 56 patients showed that the HeartMan system significantly improved self-care behavior (P=.02), whereas depression and anxiety rates were significantly reduced (P<.001), as were perceived sexual problems (P=.01). According to the Unified Theory of Acceptance and Use of Technology questionnaire, a positive attitude toward HeartMan was seen among end users, resulting in increased awareness, self-monitoring, and empowerment. CONCLUSIONS: The HeartMan project combined a range of advanced technologies with human-centered design to develop a complex system that was shown to help patients with CHF. More psychological than physical benefits were observed. TRIAL REGISTRATION: ClinicalTrials.gov NCT03497871; https://clinicaltrials.gov/ct2/history/NCT03497871. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12872-018-0921-2.

Designing a Patient Portal for Patient-Centered Care: Cross-Sectional Survey.

BACKGROUND: In recent literature, patient portals are considered as important tools for the delivery of patient-centered care. To date, it is not clear how patients would conceptualize a patient portal and which health information needs they have when doing so. OBJECTIVE: This study aimed (1) to investigate health information needs, expectations, and attitudes toward a patient portal and (2) to assess whether determinants, such as patient characteristics, health literacy, and empowerment status, can predict two different variables, namely the importance people attribute to obtaining health information when using a patient portal and the expectations concerning personal health care when using a patient portal. METHODS: We conducted a cross-sectional survey of the Flemish population on what patients prefer to know about their digital health data and their expectations and attitudes toward using a patient portal to access their electronic health record. People were invited to participate in the survey through newsletters, social media, and magazines. We used a questionnaire including demographics, health characteristics, health literacy, patient empowerment, and patient portal characteristics. RESULTS: We received 433 completed surveys. The health information needs included features such as being notified when one's health changes (371/396, 93.7%), being notified when physical parameters increase to dangerous levels (370/395, 93.7%), observing connections between one's symptoms or diseases or biological parameters (339/398, 85.2%), viewing the evolution of one's health in function of time (333/394, 84.5%), and viewing information about the expected effect of treatment (349/395, 88.4%). Almost 90% (369/412) of respondents were interested in using a patient portal. Determinants of patients' attachment for obtaining health information on a patient portal were (1) age between 45 and 54 years (P=.05); (2) neutral (P=.03) or interested attitude (P=.008) toward shared decision making; and (3) commitment to question physicians' decisions (P=.03, R2=0.122). Determinants of patients' expectations on improved health care by accessing a patient portal were (1) lower education level (P=.04); (2) neutral (P=.03) or interested attitude (P=.008) toward shared decision making; and (3) problems in understanding health information (P=.04; R2=0.106). CONCLUSIONS: The interest in using a patient portal is considerable in Flanders. People would like to receive alerts or some form of communication from a patient portal in case they need to act to manage their health. Determinants such as education, attached importance to shared decision making, difficulties in finding relevant health information, and the attached importance in questioning the decisions of physicians need to be considered in the design of a patient portal.

Lessons Learned from Participatory Design in Dementia Care: Placing Care Partners at the Centre.

In this paper we analyze the participatory design (PD) process of a health information technology (HIT) project. This project, AToM was situated in dementia care and involved partners from academia, industry and care. The analysis specifically focuses on the role of the care partners in the PD process. We will show that the conditions to enable 'good participatory design' were not fully met and we present a set of actions to prevent this in future HIT projects. Central to our recommended approach is placing the care partners at the centre of the PD project.

Are seat design processes of students similar to those of professionals?

BACKGROUND: Designers develop their basic competences during their design education and these competences are later amplified and refined during their professional career. Therefore, one could expect that the design processes of professionals and of student designers are conducted differently, and that these processes consist of different components (steps, actions, methods, tools, etc. used in the design process). OBJECTIVE: The differences and similarities between the design processes of design students and professionals were studied. In addition the effect of the designers experience on the design process is studied. METHODS: The design processes of seating products of 19 professional designers, 15 master students and 16 bachelor students were compared in order to understand the differences in the components they apply in their design process. RESULTS: The results showed significant differences between professional designers and design students for eight out of fifteen of the components. The components for which differences were found were applied more frequently by professionals than by students. For six of the components significant positive correlations were found with the designer's experience. CONCLUSIONS: There are significant differences between the design processes of design students as well as similarities. The differences amongst others related to the designers' experience.

The amount of ergonomics and user involvement in 151 design processes.

Ergonomics, usability and user-centered design are terms that are well known among designers. Yet, products often seem to fail to meet the users' needs, resulting in a gap between expected and experienced usability. To understand the possible causes of this gap the actions taken by the designer during the design process are studied in this paper. This can show whether and how certain actions influence the user-friendliness of the design products. The aim of this research was to understand whether ergonomic principles and methods are included in the design process, whether users are involved in this process and whether the experience of the designer (in ergonomics/user involvement) has an effect on the end product usability. In this study the design processes of 151 tangible products of students in design were analyzed. It showed that in 75% of the cases some ergonomic principles were applied. User involvement was performed in only 1/3 of the design cases. Hardly any correlation was found between the designers' experience in ergonomic principles and the way they applied it and no correlations were found between the designers' experience in user involvement and the users' involvement in the design process.

The use of standard calendar software by individuals with acquired brain injury and cognitive complaints: a mixed methods study.

PURPOSE: To explore the actual use of standard calendar software by people with acquired brain injury (ABI) and healthy individuals. METHOD: Mixed methods design with qualitative and quantitative analyses of the respondents' use of calendar software. Fifteen individuals with ABI and 15 healthy participants were enrolled. Participants were asked to execute five consecutive tasks using standard calendar software, which resembled everyday use of an electronic calendar. RESULTS: The core processes "task execution" and "information processing" were influenced by internal factors (cognitive and emotional processes and fatigue) as well as environmental factors (software features and distractions). Results obtained by qualitative and quantitative methods showed similar reaction patterns in both groups. However, ABI patients had more cognitive problems and showed stronger emotions during task performance than healthy participants. Healthy participants were more successful and needed less time and mental effort to perform a task. CONCLUSIONS: Although ABI patients were able to use standard calendar software, they became upset more easily, needed more effort, became tired sooner and more suddenly. Strategies to support ABI patients in the use of calendar software are suggested from multi-disciplinary perspectives.

Effects of computer training and internet usage on cognitive abilities in older adults: a randomized controlled study.

BACKGROUND AND AIMS: According to the concepts of 'use it or lose it' and cognitive reserve, cognitively challenging activities may boost cognitive abilities in older adults. Using computers and the internet provides divergent cognitive challenges to older persons, and the positive effects of computers and internet use on the quality of life have been found in earlier studies. METHODS: We investigated whether prolonged guided computer use by healthy older adults (64-75) may be beneficial to cognitive ability in a randomized controlled study. The intervention consisted of brief training and subsequent use of a personal computer with an internet connection at home for a 12-month period. 191 participants were randomly assigned to three groups: Intervention, Training/No intervention, or No training/No intervention. A fourth group consisted of 45 participants with no interest in computer use. The effect of the intervention was assessed by a range of well-established cognitive instruments that probed verbal memory, information processing speed, and cognitive flexibility. Data were collected at baseline and after four and twelve months. RESULTS: Intensive interaction with a personal computer with standard software applications had no effect on cognitive measures; no differences in changes in cognitive parameters over time were found between groups. CONCLUSION: Learning to use a computer and the internet does not benefit healthy, communitydwelling older adults with respect to many domains of cognitive functions. The implications of these findings for future studies that use cognitive challenge to counteract usual cognitive aging are discussed.

Effects of computer training and Internet usage on the well-being and quality of life of older adults: a randomized, controlled study.

The quality of life of older adults may be improved by the use of computer or Web-based services. A limited number of experimental studies on this topic have shown mixed results. We carried out a randomized, controlled intervention study that aimed to examine the causal relationship between computer use and measures of physical well-being, social well-being, emotional well-being, development and activity, and autonomy. We randomly assigned a group of 191 participants to an intervention group, a training-no intervention group, or a no training-no intervention group. A fourth group consisted of 45 participants with no interest in computer use. We collected data at baseline, after 4 months, and after 12 months. The results showed that using computers and the Internet neither positively nor negatively influenced everyday functioning, well-being and mood, and the social network of healthy older individuals. We discuss possibilities for future studies.

Risk of upper limb complaints due to computer use in older persons: a randomized study.

BACKGROUND: We studied whether the twelve-month use of a standard computer would induce complaints of upper limb pain or functional limitations in older novice computer users. METHODS: Participants between 64 and 76 of age were randomly assigned to an Intervention group (n = 62), whose members received a personal computer and fast Internet access at their homes, or a No Intervention control group (n = 61), whose members refrained from computer use during the twelve month study period. RESULTS: Difference scores between baseline and twelve months assessments on both complaint (SFS) and functional health scales (SF-36) did not differ between groups (all p > .05). CONCLUSION: Prolonged, self-paced use of a standard computer interface does not put older persons at a risk of upper limb complaints or reduce functional health in older adults.