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.

Collaboration for Developing and Sustaining Community Dementia-Friendly Initiatives: A Realist Evaluation.

BACKGROUND: Dementia-friendly communities (DFCs) are seen as key to the inclusion and participation of people with dementia and carers. Dementia-friendly initiatives (DFIs) are important building blocks for the growth of DFCs. The collaboration between different stakeholders is a central aspect in developing and sustaining DFIs. AIM: This study tests and refines an initial theory about collaborating for DFIs with special attention for the involvement of people with dementia and their carers during the collaboration for DFIs. The realist approach is used for deepening contextual aspects, mechanisms, outcomes, and its explanatory power. METHODS: A participatory case study design using qualitative data (focus groups, observations, reflections, minutes from meetings, and exit interviews) was executed in four Dutch municipalities that have ambitions to become dementia- friendly communities. RESULTS: The refined theory on the collaboration for DFIs incorporates contextual aspects such as diversity, shared insights, and clarity. It draws attention to the importance of mechanisms such as the recognition of efforts and progress, informal distributed leadership, interdependency, belonging, significance, and commitment. These mechanisms resonate with feeling useful and feeling collectively powerful in the collaboration. The outcomes of collaboration were activation, getting new ideas, and fun. Our findings address how stakeholders' routines and perspectives impact the involvement of people with dementia and their carers during collaboration. CONCLUSION: This study provides detailed information about collaboration for DFIs. The collaboration for DFIs is largely influenced by feeling useful and collectively powerful. Further research is needed to understand how these mechanisms can be triggered with the involvement of people with dementia and their carers in the heart of the collaboration.

What matters in development and sustainment of community dementia friendly initiatives and why? A realist multiple case study.

BACKGROUND: Dementia friendly communities (DFCs) are seen as key to participation of people with dementia and carers. Dementia-friendly initiatives (DFI) are important building blocks for the growth of DFCs. Therefore, it is essential to understand how DFIs are developed and sustained to secure the growth of DFCs. This study identifies contextual factors and mechanisms that influence the development and sustainment of Dutch DFIs. It also explains how these contextual factors and mechanisms are interrelated and the outcomes to which they lead. METHODS: Mixed methods, namely interviews, observations, documentation and focus groups, were used for this realist multiple case study. Participants were professionals (n = 46), volunteers (n = 20), people with dementia (n = 1) and carers (n = 2) who were involved in development and sustainment of DFIs in four Dutch DFCs. RESULTS: This study revealed three middle-range program theories as final outcomes: development of a support base, collaboration, and participation in DFIs by people with dementia and carers. These theories address institutional, organisational, interpersonal and individual levels in the community that are essential in development and sustainment of DFIs. CONCLUSIONS: The development and sustainment of DFIs requires the development of a support base, collaboration, and participation in DFIs by people with dementia and their carers.

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.

Perceived added value of a decision support App for formal caregivers in community-based dementia care.

AIMS AND OBJECTIVES: To gain insight into the perceived added value of a decision support App for district nurses and case managers intended to support a problem assessment and the provision of advices on possible solutions to facilitate ageing in place of people with dementia, and to investigate how they would implement the App in daily practice. BACKGROUND: District nurses and case managers play an important role in facilitating ageing in place of people with dementia (PwD). Detecting practical problems preventing PwD from living at home and advising on possible solutions is complex and challenging tasks for nurses and case managers. To support them with these tasks, a decision support App was developed. METHODS: A qualitative study using semi-structured interviews was conducted. A photo-elicitation method and an interview guide were used to structure the interviews. The data were analysed according to the principles of content analysis. RESULTS: In five interviews with seven district nurses and case managers, the added value was described in terms of five themes: (a) providing a broader/better overview of possible solutions; (b) providing a guideline/checklist for problem assessment and advice on solutions; (c) supporting an in-depth problem assessment; (d) being a support tool for unexperienced case managers/district nurses; and (e) providing up-to-date information. The participants regarded the App as complementary to their current work procedure, which they would use in a flexible manner at different stages in the care continuum. CONCLUSIONS: The participants valued both parts, the problem assessment and the overview of possible solutions. An important requisite for the usage would be that the content is continuously updated. Before implementation of the App can be recommended, an evaluation of its effectiveness regarding decision-making should be conducted. RELEVANCE TO CLINICAL PRACTICE: This study underpins the need of nurses and case managers for decision support with regard to problem assessment and providing advices on possible solutions to facilitate ageing in place of PwD. There results also show the importance of listening to users experience and their perceived added value of decision support tools as this helps to explain the lack of statistically significant effects on quantitative outcome measure in contrast to a high willingness to use the App in a previous study.

Roles, Strengths and Challenges of Using Robots in Interventions for Children with Autism Spectrum Disorder (ASD).

The aim of this research was to study roles, strengths and challenges of robot-mediated interventions using robot KASPAR for children with autism spectrum disorder (ASD). Twelve focus group sessions were organized in which 70 ASD care and/or education professionals participated. Six roles for KASPAR were identified: provoker, reinforcer, trainer, mediator, prompter, and diagnostic information provider. Strengths of KASPAR are related to personalisation possibilities, its playfulness, the action-reaction principle, its neutral expression, consistent and repetitive application of actions, possibilities to vary behaviour in a controlled manner and having an extra hand. Challenges of working with KASPAR were: limited reaction possibilities, possibility of children being scared of KASPAR, difficulties with generalisation or transfer and finally potential dependence on KASPAR.

Evaluation of a decision support app for nurses and case managers to facilitate aging in place of people with dementia. A randomized controlled laboratory experiment.

Detecting practical problems of persons with dementia (PwD) experience at home, and advising them on solutions to facilitate aging in place are complex and challenging tasks for nurses and case managers. In this two group randomized, controlled laboratory experiment, the efficacy of a decision support application aiming to increase nurses' and case managers' confidence in clinical judgment and decision-making was tested. The participants (N = 67) assessed a case of a PwD within the problem domains: self-reliance, safety and informal care, and provided suggestions for possible solutions. Participants used either their regular procedure with (intervention group) or without the App (control group) to conduct these tasks. No statistically significant difference was found on the primary outcome measure, the overall level of confidence. However, nurses and case managers highly recommended use of the App in practice. To explain these results, more research on the potential added value of the App is needed.

Facilitating aging in place: A qualitative study of practical problems preventing people with dementia from living at home.

Although the majority of people with dementia wish to age in place, they are particularly susceptible to nursing home admission. Nurses can play an important role in detecting practical problems people with dementia and their informal caregivers are facing and in advising them on various ways to manage these problems at home. Six focus group interviews (n = 43) with formal and informal caregivers and experts in the field of assistive technology were conducted to gain insight into the most important practical problems preventing people with dementia from living at home. Problems within three domains were consistently described as most important: informal caregiver/social network-related problems (e.g. high load of care responsibility), safety-related problems (e.g. fall risk, wandering), and decreased self-reliance (e.g. problems regarding self-care, lack of day structure). To facilitate aging in place and/or to delay institutionalization, nurses in community-based dementia care should focus on assessing problems within those three domains and offer potential solutions.

Robot ZORA in rehabilitation and special education for children with severe physical disabilities: a pilot study.

The aim of this study was to explore the potential of ZORA robot-based interventions in rehabilitation and special education for children with severe physical disabilities. A two-centre explorative pilot study was carried out over a 2.5-month period involving children with severe physical disabilities with a developmental age ranging from 2 to 8 years. Children participated in six sessions with the ZORA robot in individual or in group sessions. Qualitative and quantitative methods were used to collect data on aspects of feasibility, usability, barriers and facilitators for the child as well as for the therapist and to obtain an indication of the effects on playfulness and the achievement of goals. In total, 17 children and seven professionals participated in the study. The results of this study show a positive contribution of ZORA in achieving therapy and educational goals. Moreover, sessions with ZORA were indicated as playful. Three main domains were indicated to be the most promising for the application of ZORA: movement skills, communication skills and cognitive skills. Furthermore, ZORA can contribute towards eliciting motivation, concentration, taking initiative and improving attention span of the children. On the basis of the results of the study, it can be concluded that ZORA has potential in therapy and education for children with severe physical disabilities. More research is needed to gain insight into how ZORA can be applied best in rehabilitation and special education.

How to Implement Robots in Interventions for Children with Autism? A Co-creation Study Involving People with Autism, Parents and Professionals.

The aim of this study was to gain insight into how robots can be practically implemented into current education and therapy interventions for children with autism spectrum disorder (ASD). This qualitative study included focus groups and co-creation sessions. 73 Participants (professionals and adults with ASD) took part in 13 focus groups to elicit requirements for robot assisted interventions. Additionally, 22 participants (professionals, parents of children with ASD and adults with ASD) generated ideas for interventions using robot KASPAR in three co-creation sessions. This study resulted in: an overview of requirements concerning the robot, end-user, environment and practical implementation; a template to systematically describe robot interventions in general and for KASPAR in particular; and finally new interventions.

Can the IROMEC robot support play in children with severe physical disabilities? A pilot study.

The aim of this study was to explore the application of the IROMEC (Interactive social RObotic Mediators as Companions) robot to support play for children with severe physical disabilities in rehabilitation and special education. Within a 2-month pilot study, physically disabled children with a developmental age between 2 and 8 years participated in sessions with the robot. A combination of qualitative and quantitative outcome measures was used to collect data on aspects of feasibility, usability, barriers for the child as well as the therapist and an indication of the effects on playfulness and the achievement of therapeutic and educational goals. A total of 11 children participated in this study (four boys, seven girls). Individually Prioritized Problem Assessment scores indicated a positive effect of the IROMEC robot on the achievement of goals for the children. Professionals did observe meaningful application possibilities, but the lacking adaptability, expandability and technical stability of the robot platform make application in daily care practice impossible. The application of a robot like IROMEC for children with severe physical disabilities seems to be positive and worthwhile, but usability and feasibility aspects are crucial for success.

Mapping Robots to Therapy and Educational Objectives for Children with Autism Spectrum Disorder.

The aim of this study was to increase knowledge on therapy and educational objectives professionals work on with children with autism spectrum disorder (ASD) and to identify corresponding state of the art robots. Focus group sessions (n = 9) with ASD professionals (n = 53) from nine organisations were carried out to create an objectives overview, followed by a systematic literature study to identify state of the art robots matching these objectives. Professionals identified many ASD objectives (n = 74) in 9 different domains. State of the art robots addressed 24 of these objectives in 8 domains. Robots can potentially be applied to a large scope of objectives for children with ASD. This objectives overview functions as a base to guide development of robot interventions for these children.

Robots and ICT to support play in children with severe physical disabilities: a systematic review.

PURPOSE: Play is an essential part of children's lives. Children with physical disabilities experience difficulties in play, especially those with severe physical disabilities. With the progress of innovative technology, the possibilities to support play are increasing. The purpose of this literature study is to gain insight into the aims, control options and commercial availability of information and communication technology (ICT) and robots to support play (especially play for the sake of play) in children with severe physical disabilities. METHODS: A systematic literature search in the databases PubMed, CINAHL, IEEE and ERIC was carried out. Titles and abstracts were assessed independently by three reviewers. In addition, studies were selected using Google Scholar, conference proceedings and reference lists. RESULTS: Three main groups of technology for play could be distinguished: robots (n = 8), virtual reality systems (n = 15) and computer systems (n = 4). Besides, ICT and robots developed for specific therapy or educational goals using play-like activities, five of the in total 27 technologies in this study described the aim of "play for play's sake". CONCLUSIONS: Many ICT systems and robots to support play in children with physical disabilities were found. Numerous technologies use play-like activities to achieve therapeutic or educational goals. Robots especially are used for "play for play's sake". Implications for Rehabilitation This study gives insight into the aims, control options and commercial availability for application of robots and ICT to support play in children with severe physical disabilities. This overview can be used in both the fields of rehabilitation and special education to search for new innovative intervention options and it can stimulate them to use these innovative play materials. Especially robots may have great potential in supporting "play for play's sake".

Multidisciplinary Views on Applying Explicit and Implicit Motor Learning in Practice: An International Survey.

BACKGROUND: A variety of options and techniques for causing implicit and explicit motor learning have been described in the literature. The aim of the current paper was to provide clearer guidance for practitioners on how to apply motor learning in practice by exploring experts' opinions and experiences, using the distinction between implicit and explicit motor learning as a conceptual departure point. METHODS: A survey was designed to collect and aggregate informed opinions and experiences from 40 international respondents who had demonstrable expertise related to motor learning in practice and/or research. The survey was administered through an online survey tool and addressed potential options and learning strategies for applying implicit and explicit motor learning. Responses were analysed in terms of consensus (≥ 70%) and trends (≥ 50%). A summary figure was developed to illustrate a taxonomy of the different learning strategies and options indicated by the experts in the survey. RESULTS: Answers of experts were widely distributed. No consensus was found regarding the application of implicit and explicit motor learning. Some trends were identified: Explicit motor learning can be promoted by using instructions and various types of feedback, but when promoting implicit motor learning, instructions and feedback should be restricted. Further, for implicit motor learning, an external focus of attention should be considered, as well as practicing the entire skill. Experts agreed on three factors that influence motor learning choices: the learner's abilities, the type of task, and the stage of motor learning (94.5%; n = 34/36). Most experts agreed with the summary figure (64.7%; n = 22/34). CONCLUSION: The results provide an overview of possible ways to cause implicit or explicit motor learning, signposting examples from practice and factors that influence day-to-day motor learning decisions.

An overview of potential labor-saving and quality-improving innovations in long-term care for older people.

OBJECTIVES: Increasing demands in long-term care for older people and a decrease in workforce availability can be expected in the future. These developments challenge the sustainability and quality of long-term care for older people. To address these challenges, long-term care organizations are forced to innovate. The aim of this study is to provide an overview of potential labor-saving and quality-improving innovations long-term care organizations are working on and to assess the self-reported extent of effectiveness. DESIGN: This is a descriptive cross-sectional study. METHODS: In total, 32 long-term care organizations in the region of Limburg in The Netherlands were invited to participate in the study. The inventory was performed by means of semistructured interviews with chief executive officers, managers, and staff members of the long-term care organizations. Based on the interview data, all innovations were described in a standardized form and subsequently checked by the participants. All innovations were clustered into product, process, organizational, and marketing innovations. RESULTS: In total, 26 long-term care organizations delivering home and/or institutional long-term care for older people participated in the study. Overall, 228 innovations were identified; some innovations were described in a similar way by different organizations. The majority of innovations were product innovations (n = 96), followed by organizational innovations (n = 75), and process innovations (n = 42). In addition to the main types, 15 other innovations incorporating characteristics of different types of innovations were detected. Little evidence about the effectiveness of the innovations was reported by the organizations. CONCLUSIONS: This study shows that a large number and a broad variety of innovations have been implemented or are currently being developed in long-term care organizations for older people. However, according to the organizations, there is relatively little (scientific) evidence confirming the effectiveness of these innovations. More research is needed to evaluate the effects of the innovations and to indicate whether they provide real solutions to future challenges.

Literature review on monitoring technologies and their outcomes in independently living elderly people.

PURPOSE: To obtain insight into what kind of monitoring technologies exist to monitor activity in-home, what the characteristics and aims of applying these technologies are, what kind of research has been conducted on their effects and what kind of outcomes are reported. METHODS: A systematic document search was conducted within the scientific databases Pubmed, Embase, Cochrane, PsycINFO and Cinahl, complemented by Google Scholar. Documents were included in this review if they reported on monitoring technologies that detect activities of daily living (ADL) or significant events, e.g. falls, of elderly people in-home, with the aim of prolonging independent living. RESULTS: Five main types of monitoring technologies were identified: PIR motion sensors, body-worn sensors, pressure sensors, video monitoring and sound recognition. In addition, multicomponent technologies and smart home technologies were identified. Research into the use of monitoring technologies is widespread, but in its infancy, consisting mainly of small-scale studies and including few longitudinal studies. CONCLUSIONS: Monitoring technology is a promising field, with applications to the long-term care of elderly persons. However, monitoring technologies have to be brought to the next level, with longitudinal studies that evaluate their (cost-) effectiveness to demonstrate the potential to prolong independent living of elderly persons. [Box: see text].

Prevention of long-term sickness absence and major depression in high-risk employees: a randomised controlled trial.

OBJECTIVES: To examine the efficacy of early intervention on the prevention of long-term sickness absence and major depression among employees at high risk of future sickness absence and with mild to severe depressive complaints. METHODS: Randomised controlled trial conducted among employees working in an office environment. 139 employees were identified both at high risk of future sickness absence and with mild to severe depressive complaints through screening. Subsequently, they were randomly assigned to the intervention group (n = 69) or the control group (n = 70). Objective sickness absence was analysed at 12 and 18 months of follow-up. Depressive complaints were assessed by the Beck Depression Inventory (BDI-II) at baseline, and at 6 and 12 months of follow-up. RESULTS: Intention-to-treat analyses showed a significant difference in total sickness absence duration between the intervention (27.5 calendar days (SD 44.7)) and control group (50.8 days (SD 75.8)) over 12 months of follow-up, a reduction of 46% (p = 0.017). The intervention group showed a non-significantly lower proportion of long-term sickness absence spells compared with the control group (p = 0.127). Statistically significant and clinically relevant differences in depressive complaints were found after both 6 months (p = 0.001) and 12 months (p = 0.005) of follow-up, in favour of the intervention group. Relative risk reductions (RRR) were 19.2% and 19.8% respectively. Sickness absence data were available for all participants over 18 months of follow-up. Questionnaire data were available for 99 (at 6 months) and 90 participants (at 12 months). No adverse events or side effects occurred. CONCLUSIONS: Early intervention in employees with mild to severe depressive complaints and high risk of future long-term sickness absence proved to be effective in preventing/reducing both sickness absence and depressive complaints.

Impact of chronic total occlusions on markers of reperfusion, infarct size, and long-term mortality: a substudy from the TAPAS-trial.

OBJECTIVES: This study evaluated the impact of a chronic total occlusion (CTO) in a non-infarct related coronary artery (IRA) on markers of reperfusion, infarct size, and long-term cardiac mortality in patients with ST-elevation myocardial infarction (STEMI). BACKGROUND: A concurrent CTO in STEMI patients has been associated with impaired left ventricular function and outcome. However, the impact on markers of reperfusion is unknown. METHODS: All 1,071 STEMI patients included in the TAPAS-trial between January 2005 and December 2006 were used for this substudy. Endpoints were the association between a CTO in a non-IRA and myocardial blush grade (MBG) of the IRA, ST-segment elevation resolution (STR), enzymatic infarct size, and clinical outcome. RESULTS: A total of 90 patients (8.4%) had a CTO. MBG 0 or 1 occurred more often in the CTO group (34.2% versus 20.6% (Odds Ratio [OR] 2.00, 95% confidence interval [CI]: 1.22-3.23, P = 0.006)). Incomplete STR occurred more often in the CTO group, (63.6% versus 48.2% [OR 1.96, 95% CI: 1.22-3.13, P = 0.005]). Median level of maximal myocardial-band of creatinin kinase (CK-MB) in the CTO group was 75 µg/l (IQR 28-136) and 51 µg/l (IQR 18-97) in the no-CTO group (P = 0.021). The presence of a CTO in a non-IRA in STEMI patients was an independent risk factor for cardiac mortality (HR 2.41, 95% CI: 1.26-4.61, P = 0.008) at 25 months follow-up. CONCLUSION: A CTO in a non-IRA is associated with impaired reperfusion markers and impaired long-term outcome in STEMI patients.

Depressive complaints as a predictor of sickness absence among the working population.

OBJECTIVE: To study the relationship between depressive complaints and sickness absence in the working population. METHODS: Data from a prospective epidemiological cohort (n = 3339) were used. Depressive complaints were measured with the Hospital Anxiety and Depression (HAD-D) Scale. Sickness absence was assessed objectively through individual record linkage with the company registers. RESULTS: Higher levels of depressive complaints were associated with a shorter time to first sickness absence spell and a longer duration of sickness absence. In women with mild depressive complaints, the average number of sickness absence days over 10 months follow-up was 27.37 (SD = 64.73) days versus 11.01 (SD = 30.03) days (P < 0.001) in employees scoring within the reference range. In men this was 14.48 (SD = 38.73) days versus 7.67 (SD = 25.80) days (P < 0.001). CONCLUSIONS: Prevention of mild depressive complaints might be beneficial in preventing future sickness absence.