Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study.

The potential of real-world data to inform clinical trial design and supplement control arms has gained much interest in recent years. The most common approach relies on reproducing control arm outcomes by matching real-world patient cohorts to clinical trial baseline populations. However, recent studies pointed out that there is a lack of replicability, generalisability, and consensus. In this article, we propose a novel approach that aims to explore and examine these discrepancies by concomitantly investigating the impact of selection criteria and operations on the measurements of outcomes from the patient data. We tested the approach on a dataset consisting of small-cell lung cancer patients receiving platinum-based chemotherapy regimens from a real-world data cohort (n = 223) and six clinical trial control arms (n = 1224). The results showed that the discrepancy between real-world and clinical trial data potentially depends on differences in both patient populations and operational conditions (e.g., frequency of assessments, and censoring), for which further investigation is required. Discovering and accounting for confounders, including hidden effects of differences in operations related to the treatment process and clinical trial study protocol, would potentially allow for improved translation between clinical trials and real-world data. Continued development of the method presented here to systematically explore and account for these differences could pave the way for transferring learning across clinical studies and developing mutual translation between the real-world and clinical trials to inform clinical study design.

Exploring Hospital Overcrowding with an Explainable Time-to-Event Machine Learning Approach.

Emergency department (ED) overcrowding is a complex problem that is intricately linked with the operations of other hospital departments. Leveraging ED real-world production data provides a unique opportunity to comprehend this multifaceted problem holistically. This paper introduces a novel approach to analyse healthcare production data, treating the length of stay of patients, and the follow up decision regarding discharge or admission to the hospital as a time-to-event analysis problem. Our methodology employs traditional survival estimators and machine learning models, and Shapley additive explanations values to interpret the model outcomes. The most relevant features influencing length of stay were whether the patient received a scan at the ED, emergency room urgent visit, age, triage level, and the medical alarm unit category. The clinical insights derived from the explanation of the models holds promise for increase understanding of the overcrowding from the data. Our work demonstrates that a time-to-event approach to the over- crowding serves as a valuable initial to uncover crucial insights for further investigation and policy design.

Diagnosing an overcrowded emergency department from its Electronic Health Records.

Emergency department overcrowding is a complex problem that persists globally. Data of visits constitute an opportunity to understand its dynamics. However, the gap between the collected information and the real-life clinical processes, and the lack of a whole-system perspective, still constitute a relevant limitation. An analytical pipeline was developed to analyse one-year of production data following the patients that came from the ED (n = 49,938) at Uppsala University Hospital (Uppsala, Sweden) by involving clinical experts in all the steps of the analysis. The key internal issues to the ED were the high volume of generic or non-specific diagnoses from non-urgent visits, and the delayed decision regarding hospital admission caused by several imaging assessments and lack of hospital beds. Furthermore, the external pressure of high frequent re-visits of geriatric, psychiatric, and patients with unspecified diagnoses dramatically contributed to the overcrowding. Our work demonstrates that through analysis of production data of the ED patient flow and participation of clinical experts in the pipeline, it was possible to identify systemic issues and directions for solutions. A critical factor was to take a whole systems perspective, as it opened the scope to the boundary effects of inflow and outflow in the whole healthcare system.

Tensions between real-world practices and the digitalization paradigm for data-driven services in eldercare: observations from an ethnographic study in Sweden.

BACKGROUND: The implementation of a data-driven approach within the health care system happens in a rapid pace; including in the eldercare sector. Within Swedish eldercare, data-driven health approach is not yet widely implemented. In the specific context of long-term care for older adults, quality of care is as much determined by how social care is being performed as it is by what kind medical care that is provided. In particular, relational aspects have been proven to have a crucial influence on the experience of quality of care for the actors involved. Drawing on ethnographic material collected at a Swedish nursing home, this paper explores in what way the relational aspects of care could potentially become affected by the increased use of a data-driven health approach. METHODS: An ethnographic approach was adopted in order to investigate the daily care work at a long-term care facility as it unfolded. Fieldwork was conducted at a somatic ward in a Swedish long-term care facility over 4 months (86 h in total), utilizing the methods of participant observation, informal interviews and document analysis. The material was analyzed iteratively throughout the entire research process adopting thematic analysis. RESULTS: Viewing our ethnographic material through an observational lense problematising the policy discourse around data-driven health approach, two propositions were developed. First, we propose that relational knowledge risk becoming less influential in shaping everyday care, when moving to a data-driven health approach. Second, we propose that quality of care risk becoming more directed on quality of medical care at the expense of quality of life. CONCLUSION: While the implementation of data-driven health approach within long-term care for older adults is not yet widespread, the general development within health care points towards a situation in which this will become reality. Our study highlights the importance of taking the relational aspects of care into consideration, both during the planning and implementation phase of this process. By doing this, the introduction of a data-driven health approach could serve to heighten the quality of care in a way which supports both quality of medical care and quality of life.

Research on transportation management model of COVID-19 medical waste: a case study in Beijing, China.

During the COVID-19 pandemic, disposable masks, protective clothing, gloves, and nasopharyngeal swabs collected by nucleic acid testing formed a large amount of medical waste. Medical waste has strict temporary storage time requirements in hospitals, which need to be transported to medical waste disposal plants within the specified time. However, as most of disposal plants are far away from downtown, they also need to be responsible for the transportation and disposal of medical waste in many hospitals, and put forward higher requirement for transportation routes. Rapid and safe disposal of all types of medical waste generated by COVID-19 is crucial to the prevention and control of the epidemic. This paper designs the transportation route optimization model using Anylogic simulation software based on the regional distribution of 118 tertiary hospitals and 2 large medical waste disposal plants in Beijing, China. At the same time, transportation routes of 118 tertiary hospitals in the morning peak, evening peak, all-day, and ordinary periods were simulated based on the Beijing traffic index in 2017. On this basis, through the analysis of the simulation data, the selection of medical waste transport routes for 118 tertiary hospitals in the morning peak, evening peak, all day, and ordinary periods is further clarified, so as to ensure that medical waste can be transported to the medical waste disposal plant in the shortest time. The shortest path and fastest speed transport mode, medical waste transport data set, and the selection of transport mode of 118 tertiary hospitals formed by this research provide certain reference experience for the rapid and safe transport of medical waste during the epidemic period, and also provides corresponding data support for medical waste transportation management in the post-epidemic era and medical waste transportation decision-making when facing major public health problems.

Investigating the Connections Between Delivery of Care, Reablement, Workload, and Organizational Factors in Home Care Services: Mixed Methods Study.

BACKGROUND: Home care is facing increasing demand due to an aging population. Several challenges have been identified in the provision of home care, such as the need for support and tailoring support to individual needs. Goal-oriented interventions, such as reablement, may provide a solution to some of these challenges. The reablement approach targets adaptation to disease and relearning of everyday life skills and has been found to improve health-related quality of life while reducing service use. OBJECTIVE: The objective of this study is to characterize home care system variables (elements) and their relationships (connections) relevant to home care staff workload, home care user needs and satisfaction, and the reablement approach. This is to examine the effects of improvement and interventions, such as the person-centered reablement approach, on the delivery of home care services, workload, work-related stress, home care user experience, and other organizational factors. The main focus was on Swedish home care and tax-funded universal welfare systems. METHODS: The study used a mixed methods approach where a causal loop diagram was developed grounded in participatory methods with academic health care science research experts in nursing, occupational therapy, aging, and the reablement approach. The approach was supplemented with theoretical models and the scientific literature. The developed model was verified by the same group of experts and empirical evidence. Finally, the model was analyzed qualitatively and through simulation methods. RESULTS: The final causal loop diagram included elements and connections across the categories: stress, home care staff, home care user, organization, social support network of the home care user, and societal level. The model was able to qualitatively describe observed intervention outcomes from the literature. The analysis suggested elements to target for improvement and the potential impact of relevant studied interventions. For example, the elements "workload" and "distress" were important determinants of home care staff health, provision, and quality of care. CONCLUSIONS: The developed model may be of value for informing hypothesis formulation, study design, and discourse within the context of improvement in home care. Further work will include a broader group of stakeholders to reduce the risk of bias. Translation into a quantitative model will be explored.

Application of Process Mining for Modelling Small Cell Lung Cancer Prognosis.

Process mining is a relatively new method that connects data science and process modelling. In the past years a series of applications with health care production data have been presented in process discovery, conformance check and system enhancement. In this paper we apply process mining on clinical oncological data with the purpose of studying survival outcomes and chemotherapy treatment decision in a real-world cohort of small cell lung cancer patients treated at Karolinska University Hospital (Stockholm, Sweden). The results highlighted the potential role of process mining in oncology to study prognosis and survival outcomes with longitudinal models directly extracted from clinical data derived from healthcare.

Preventing frailty with the support of a home-monitoring and communication platform among older adults-a study protocol for a randomised-controlled pilot study in Sweden.

BACKGROUND: POSITIVE (i.e. maintaining and imPrOving the intrinSIc capaciTy Involving primary care and caregiVErs) is a new intervention program consisting of home-monitoring equipment and a communication platform to support treatment of frailty symptoms initially in primary care and prevent disability in older adults. METHODS: The primary objectives are to estimate the potential efficacy of the POSITIVE system on improving frailty in at least one point in Fried's criteria and five points in Frailty Trait Scale. The secondary objectives are to (A) assess the recruitment, retention, drop-out rates, compliance with the intervention and the intervention mechanisms of impact; (B) evaluate the usability and acceptance of the POSITIVE system, and to get estimations on; (C) the potential efficacy of the intervention on improving the participants' physical performance, cognitive functions, mood, independency level in activities in daily living, the impact on quality of life and number of falls during the follow-up period; (D) the impact on the caregiver quality of life and caregiver burden; and (E) on the consumption of health care resources, participants' perception of health and level of care received, and healthcare professionals' workload and satisfaction. A randomised controlled, assessor-blinded pilot study design recruiting from a primary care centre in Stockholm Region will be conducted. Fifty older adults identified as pre-frail or frail will be randomised into a control or an intervention group. Both groups will receive a medical review, nutritional recommendations and Vivifrail physical exercise program. The intervention group will receive the POSITIVE-system including a tablet, the POSITIVE application and portable measurement devices. The participants receiving the POSITIVE program will be monitored remotely by a primary care nurse during a 6-month follow-up. Data will be collected at baseline, 3 and 6 months into the intervention though the platform, standardised assessments and surveys. A process evaluation as per Medical Research Council guidance will be conducted after the 6-month follow-up period. DISCUSSION: The implications of the study are to provide estimations on the potential efficacy of the POSITIVE system in improving frailty among older adults and to provide relevant data to inform powered studies of potential efficacy and effectiveness, as well as to inform about the feasibility of the current study design. TRIAL REGISTRATION: ClinicalTrials.gov. REGISTRATION NUMBER: NCT04592146 . October 19, 2020.

A novel analytical framework for risk stratification of real-world data using machine learning: A small cell lung cancer study.

In recent studies, small cell lung cancer (SCLC) treatment guidelines based on Veterans' Administration Lung Study Group limited/extensive disease staging and resulted in broad and inseparable prognostic subgroups. Evidence suggests that the eight versions of tumor, node, and metastasis (TNM) staging can play an important role to address this issue. The aim of the present study was to improve the detection of prognostic subgroups from a real-word data (RWD) cohort of patients and analyze their patterns using a development pipeline with thoracic oncologists and machine learning methods. The method detected subgroups of patients informing unsupervised learning (partition around medoids) including the impact of covariates on prognosis (Cox regression and random survival forest). An analysis was carried out using patients with SCLC (n = 636) with stage IIIA-IVB according to TNM classification. The analysis yielded k = 7 compacted and well-separated clusters of patients. Performance status (Eastern Cooperative Oncology Group-Performance Status), lactate dehydrogenase, spreading of metastasis, cancer stage, and CRP were the baselines that characterized the subgroups. The selected clustering method outperformed standard clustering techniques, which were not capable of detecting meaningful subgroups. From the analysis of cluster treatment decisions, we showed the potential of future RWD applications to understand disease, develop individualized therapies, and improve healthcare decision making.

ASSIST: a reablement program for older adults in Sweden - a feasibility study.

BACKGROUND: Western countries emphasise the provision of assistive home care by implementing reablement services. Reablement services are offered to a limited degree in Sweden, and systematic research regarding outcomes and how reablement can be tailored to maximize benefits for older adults has been lacking. This study aimed to evaluate the feasibility of a novel reablement program (ASSIST 1.0) regarding study design and outcome measures, as well as fidelity, adherence, and acceptability of the program in a Swedish context. METHOD: A non-randomised, quasi-experimental, mixed-method, pre/post-test design was applied with an intervention group receiving ASSIST 1.0 (n = 7) and a control group receiving regular home care (n = 10). ASSIST 1.0 was developed to empower older adults to increase their perceived performance and satisfaction of performing activities in everyday life as well as increase their perceived health, self-efficacy, and well-being. ASSIST 1.0 was founded on the concept of reablement and included three components: i) goal setting with The Canadian Occupational Performance Measure (COPM), ii) provided support to home care staff to enhance their provision of reablement, and iii) explored the incorporation and use of an information- and communication technology (ICT) to facilitate information transfer. RESULTS: Using COPM for goal setting with older adults and providing support to the staff via workshops were valuable components in the delivery of ASSIST 1.0. The ICT product encountered several challenges and could not be evaluated. COPM and EQ-5D were deemed the most important instruments. Organisational and political barriers affected the feasibility. Although, the fidelity and adherence were complied the staff perceived the program to be acceptable. CONCLUSION: The ASSIST 1.0 program was feasible in regard of study design, delivering the intervention, and evaluating instruments that detected a change. A logical progression would be to conduct a full-scale trial. In addition, a usability study to evaluate the technological component is also recommended. With minor improvements, the ASSIST 1.0 program has the potential to contribute to the development of a home care organisation that could enhance older adults possibility to age in place at home. TRIAL REGISTRATION NUMBER: NCT03505619.

User Experience in Remote Surgical Consultation: Survey Study of User Acceptance and Satisfaction in Real-Time Use of a Telemedicine Service.

BACKGROUND: Teleguidance, a promising telemedicine service for intraoperative surgical consultation, was planned to scale up at a major academic hospital in partnership with 5 other hospitals. If the service was adopted and used over time, it was expected to provide educational benefits and improve clinical outcomes during endoscopic retrograde cholangiopancreatography (ERCP), which is a technically advanced procedure for biliary and pancreatic disease. However, it is known that seemingly successful innovations can play out differently in new settings, which might cause variability in clinical outcomes. In addition, few telemedicine services survive long enough to deliver system-level outcomes, the causes of which are not well understood. OBJECTIVE: We were interested in factors related to usability and user experience of the telemedicine service, which might affect adoption. Therefore, we investigated perceptions and responses to the use and anticipated use of a system. Technology acceptance, a construct referring to how users perceive a technology's usefulness, is commonly considered to indicate whether a new technology will actually be used in a real-life setting. Satisfaction measures were used to investigate whether user expectations and needs have been met through the use of technology. In this study, we asked surgeons to rate the perceived usefulness of teleguidance, and their satisfaction with the telemedicine service in direct conjunction with real-time use during clinical procedures. METHODS: We designed domain-specific measures for perceived usefulness and satisfaction, based on performance and outcome measures for the clinical procedure. Surgeons were asked to rate their user experience with the telemedicine service in direct conjunction with real-time use during clinical procedures. RESULTS: In total, 142 remote intraoperative consultations were conducted during ERCP procedures at 5 hospitals. The demand for teleguidance was more pronounced in cases with higher complexity. Operating surgeons rated teleguidance to have contributed to performance and outcomes to a moderate or large extent in 111 of 140 (79.3%) cases. Specific examples were that teleguidance was rated as having contributed to intervention success and avoiding a repeated ERCP in 23 cases, avoiding 3 PTC, and 11 referrals, and in 11 cases, combinations of these outcomes. Preprocedure beliefs about the usefulness of teleguidance were generally lower than postprocedure satisfaction ratings. The usefulness of teleguidance was mainly experienced through practical advice from the consulting specialist (119/140, 85%) and support with assessment and decision-making (122/140, 87%). CONCLUSIONS: Users' satisfaction with teleguidance surpassed their initial expectations, mainly through contribution to nontechnical aspects of performance, and through help with general assessment. Teleguidance shows the potential to improve performance and outcomes during ERCP. However, it takes hands-on experience for practitioners to understand how the new telemedicine service contributes to performance and outcomes.

Context and Complexity in Telemedicine Evaluation: Work Domain Analysis in a Surgical Setting.

Many promising telemedicine innovations fail to be accepted and used over time, and there are longstanding questions about how to best evaluate telemedicine services and other health information technologies. In response to these challenges, there is a growing interest in how to take the sociotechnical complexity of health care into account during design, implementation, and evaluation. This paper discusses the methodological implications of this complexity and how the sociotechnical context holds the key to understanding the effects and outcomes of telemedicine. Examples from a work domain analysis of a surgical setting, where a telemedicine service for remote surgical consultation was to be introduced, are used to show how abstracted functional modeling can provide a structured and rigorous means to analyze and represent the implementation context in complex health care settings.

Modeling the Implementation Context of a Telemedicine Service: Work Domain Analysis in a Surgical Setting.

BACKGROUND: A telemedicine service enabling remote surgical consultation had shown promising results. When the service was to be scaled up, it was unclear how contextual variations among different clinical sites could affect the clinical outcomes and implementation of the service. It is generally recognized that contextual factors and work system complexities affect the implementation and outcomes of telemedicine. However, it is methodologically challenging to account for context in complex health care settings. We conducted a work domain analysis (WDA), an engineering method for modeling and analyzing complex work environments, to investigate and represent contextual influences when a telemedicine service was to be scaled up to multiple hospitals. OBJECTIVE: We wanted to systematically characterize the implementation contexts at the clinics participating in the scale-up process. Conducting a WDA would allow us to identify, in a systematic manner, the functional constraints that shape clinical work at the implementation sites and set the sites apart. The findings could then be valuable for informed implementation and assessment of the telemedicine service. METHODS: We conducted observations and semistructured interviews with a variety of stakeholders. Thematic analysis was guided by concepts derived from the WDA framework. We identified objects, functions, priorities, and values that shape clinical procedures. An iterative "discovery and modeling" approach allowed us to first focus on one clinic and then readjust the scope as our understanding of the work systems deepened. RESULTS: We characterized three sets of constraints (ie, facets) in the domain: the treatment facet, administrative facet (providing resources for procedures), and development facet (training, quality improvement, and research). The constraints included medical equipment affecting treatment options; administrative processes affecting access to staff and facilities; values and priorities affecting assessments during endoscopic retrograde cholangiopancreatography; and resources for conducting the procedure. CONCLUSIONS: The surgical work system is embedded in multiple sets of constraints that can be modeled as facets of the system. We found variations between the implementation sites that might interact negatively with the telemedicine service. However, there may be enough motivation and resources to overcome these initial disruptions given that values and priorities are shared across the sites. Contrasting the development facets at different sites highlighted the differences in resources for training and research. In some cases, this could indicate a risk that organizational demands for efficiency and effectiveness might be prioritized over the long-term outcomes provided by the telemedicine service, or a reduced willingness or ability to accept a service that is not yet fully developed or adapted. WDA proved effective in representing and analyzing these complex clinical contexts in the face of technological change. The models serve as examples of how to analyze and represent a complex sociotechnical context during telemedicine design, implementation, and assessment.

Current Competencies of Game Facilitators and Their Potential Optimization in Higher Education: Multimethod Study.

BACKGROUND: Serious games can be a powerful learning tool in higher education. However, the literature indicates that the learning outcome in a serious game depends on the facilitators' competencies. Although professional facilitators in commercial game-based training have undergone specific instruction, facilitators in higher education cannot rely on such formal instruction, as game facilitation is only an occasional part of their teaching activities. OBJECTIVE: This study aimed to address the actual competencies of occasional game facilitators and their perceived competency deficits. METHODS: Having many years of experience as professional and occasional facilitators, we (n=7) defined requirements for the occasional game facilitator using individual reflection and focus discussion. Based on these results, guided interviews were conducted with additional occasional game facilitators (n=4) to check and extend the requirements. Finally, a group of occasional game facilitators (n=30) answered an online questionnaire based on the results of the requirement analysis and existing competency models. RESULTS: Our review produced the following questions: Which competencies are needed by facilitators and what are their training needs? What do current training courses for occasional game facilitators in higher education look like? How do the competencies of occasional game facilitators differ from other competencies required in higher education? The key findings of our analysis are that a mix of managerial and technical competencies is required for facilitating serious games in higher educational contexts. Further, there is a limited or no general competence model for game facilitators, and casual game facilitators rarely undergo any specific, formal training. CONCLUSIONS: The results identified the competencies that game facilitators require and a demand for specific formal training. Thus, the study contributes to the further development of a competency model for game facilitators and enhances the efficiency of serious games.

Game Experience and Learning Effects of a Scoring-Based Mechanic for Logistical Aspects of Pediatric Emergency Medicine: Development and Feasibility Study.

BACKGROUND: Using serious games for learning in operations management is well established. However, especially for logistics skills in health care operations, there is little work on the design of game mechanics for learning engagement and the achievement of the desired learning goals. OBJECTIVE: This contribution presents a serious game design representing patient flow characteristics, systemic resource configurations, and the roles of the players based on a real Swedish emergency ward. The game was tested in a set of game-based learning practices in the modalities of a physical board game and an online multiplayer serious game that implemented the same game structure. METHODS: First, survey scores were collected using the Game Experience Questionnaire Core and Social Presence Modules to evaluate the experience and acceptance of the proposed design to gamify real processes in emergency care. Second, lag sequential analysis was applied to analyze the impact of the game mechanics on learning behavior transitions. Lastly, regression analysis was used to understand whether learning engagement attributes could potentially serve as significant predicting variables for logistical performance in a simulated learning environment. RESULTS: A total of 36 students from courses in engineering and management at KTH Royal Institute of Technology participated in both game-based learning practices during the autumn and spring semesters of 2019 and 2020. For the Core Module, significant differences were found for the scores for negative affect and tension compared with the rest of the module. For the Social Presence Module, significant differences were found in the scores for the psychological involvement - negative feelings dimension compared with the rest of the module. During the process of content generation, the participant had access to circulating management resources and could edit profiles. The standard regression analysis output yielded a ΔR2 of 0.796 (F14,31=2725.49, P<.001) for the board version and 0.702 (F24,31=2635.31, P<.001) for the multiplayer online version after the learning engagement attributes. CONCLUSIONS: The high scores of positive affect and immersion compared to the low scores of negative feelings demonstrated the motivating and cognitive involvement impact of the game. The proposed game mechanics have visible effects on significant correlation parameters between the majority of scoring features and changes in learning engagement attributes. Therefore, we conclude that for enhancing learning in logistical aspects of health care, serious games that are steered by well-designed scoring mechanisms can be used.

Telemedicine for Remote Surgical Guidance in Endoscopic Retrograde Cholangiopancreatography: Mixed Methods Study of Practitioner Attitudes.

BACKGROUND: Telemedicine innovations are rarely adopted into routine health care, the reasons for which are not well understood. Teleguidance, a promising service for remote surgical guidance during endoscopic retrograde cholangiopancreatography (ERCP) was due to be scaled up, but there were concerns that user attitudes might influence adoption. OBJECTIVE: Our objective was to gain a deeper understanding of ERCP practitioners' attitudes toward teleguidance. These findings could inform the implementation process and future evaluations. METHODS: We conducted semistructured interviews with ERCP staff about challenges during work and beliefs about teleguidance. Theoretical constructs from the technology acceptance model (TAM) guided the thematic analysis. Our findings became input to a 16-item questionnaire, investigating surgeons' beliefs about teleguidance's contribution to performance and factors that might interact with implementation. RESULTS: Results from 20 interviews with ERCP staff from 5 hospitals were used to adapt a TAM questionnaire, exchanging the standard "Ease of Use" items for "Compatibility and Implementation Climate." In total, 23 ERCP specialists from 15 ERCP clinics responded to the questionnaire: 9 novices (<500 ERCP procedures) and 14 experts (>500 ERCP procedures). The average agreement ratings for usefulness items were 64% (~9/14) among experts and 75% (~7/9) among novices. The average agreement ratings for compatibility items were somewhat lower (experts 64% [~9/14], novices 69% [~6/9]). The averages have been calculated from the sum of several items and therefore, they only approximate the actual values. While 11 of the 14 experts (79%) and 8 of the 9 novices (89%) agreed that teleguidance could improve overall quality and patient safety during ERCP procedures, only 8 of the 14 experts (57%) and 6 of the 9 novices (67%) agreed that teleguidance would not create new patient safety risks. Only 5 of the 14 experts (36%) and 3 of the 9 novices (33%) were convinced that video and image transmission would function well. Similarly, only 6 of the 14 experts (43%) and 6 of the 9 novices (67%) agreed that administration would work smoothly. There were no statistically significant differences between the experts and novices on any of the 16 items (P<.05). CONCLUSIONS: Both novices and experts in ERCP procedures had concerns that teleguidance might disrupt existing work practices. However, novices were generally more positive toward teleguidance than experts, especially with regard to the possibility of developing technical skills and work practices. While newly trained specialists were the main target for teleguidance, the experts were also intended users. As experts are more likely to be key decision makers, their attitudes may have a greater relative impact on adoption. We present suggestions to address these concerns. We conclude that using the TAM as a conceptual framework can support user-centered inquiry into telemedicine design and implementation by connecting qualitative findings to well-known analytical themes.

Care of family caregivers of persons with dementia (CaFCa) through a tailor-made mobile app: study protocol of a complex intervention study.

BACKGROUND: Globally, family members account for the main source of caregiving of persons with dementia living at home. Providing care to family members with dementia often has negative health consequences for caregivers such as stress, depression and low quality of life. Yet, formal support for family caregivers (FCs) is limited. Telehealth technology has the potential to provide health care and social support to FCs. This study aims to assess the effectiveness of providing support by healthcare professionals (HPs) through a mobile app in reducing stress, depressive symptoms and loneliness, and improving mental health and quality of life of FCs of persons with dementia. METHODS: Using a pragmatic intervention design, this study will use pre- and post-intervention assessment to evaluate the effectiveness of the proposed intervention in a sample of 78 FCs of persons with dementia (PWD). The intervention will be implemented by approximately 5 HPs specialized in dementia care based in the municipalities in Sweden. The main thrust of the intervention is to provide professional support, with help of an interactive mobile app, to family members in their caregiving role for PWDs. Qualitative interviews with HPs and FCs form the groundwork of the development of the mobile app. By using the app on smart phone or tablet, the FC, in groups of 8-10, will communicate with peers and a HP exchanging ideas on how to deal with PWD's behavioral and cognitive changes and get support. They will also be able to discuss stressful events and access mindfulness exercises focused on themselves. Quantitative data will be collected before and at three time points after the 8-week intervention to assess changes in the health outcomes of the FCs. In-depth interviews will be conducted after the intervention to capture the experiences of FCs and HPs regarding the ease of use and acceptability of the app. DISCUSSION: This tailor-made mobile app has the high potential to be a practical platform for supporting FCs to alleviate stress and improve mental health irrespective of distance to the nearest health care or social service center. TRIAL REGISTRATION: ISRCTN, ISRCTN46137262 . Registered 10 October 2019.

A System of Systems of Mental Health in Cities, Digging Deep into the Origins of Complexity.

Mental health in urban environments is often treated from a healthcare provision perspective. Research in recent decades showed that mental illness in cities is a result of dysfunctional coordination between different city systems and structures. Given the nature of the city as a system of systems, this work builds through a participatory method, a general system dynamic model of factors that affect mental health in urban and regional environments. Through this method, we investigated the challenges of the application of such methodology to identify essential factors, feedback loops, and dependencies between systems to move forward in planning for mental health in cities. The outcome is a general model that showed the importance of factors that vary from individuals, families to communities and feedback loops that span multiple systems such as the city physical infrastructures, social environments, schools, labor market, and healthcare provision.

Evaluation of an intervention addressing a reablement programme for older, community-dwelling persons in Sweden (ASSIST 1.0): a protocol for a feasibility study.

INTRODUCTION: Older persons with functional limitations often need assistance from home care staff to thrive and continue to live in their home environments. Reablement, a proactive, preventative approach administered by home care staff, stimulating active engagement of the older person, is often recommended. Even though reablement has a potential to become a new rehabilitation model and has been implemented in different countries in various degrees, there is a lack of knowledge regarding the process of establishing reablement, the theoretical underpinnings and the conditionality and outcomes in different contexts. This knowledge is needed before full-scale recommendations can be made for implementation in specific contexts. AIM: This study protocol aims to present a feasibility study of the intervention, ASSIST 1.0, a theory-based reablement programme, which includes coaching of home care staff and digitally based smart products, in a Swedish context. METHODS AND ANALYSIS: This feasibility study will evaluate the perceived value and acceptability of ASSIST 1.0 intervention programme regarding fidelity, reach and dose, and potential outcomes by using a pretest and post-test design involving an intervention group and a control group (n=30) of older persons living at home, needing home care services. Qualitative interviews with home care staff delivering ASSIST and the older adults receiving the intervention as well as their significant others will be conducted to explore aspects affecting the intervention. ETHICS AND DISSEMINATION: This study has been approved by the regional ethics board. The results of the feasibility study will form the base for refinement of the ASSIST programme and for the subsequent planning of a full-scale randomised controlled trial investigating the effect of the programme on a larger scale. Dissemination will include peer-reviewed publications and presentations at national and international conferences as well as information to involved stakeholders. TRIAL REGISTRATION NUMBER: NCT03505619.