Investigating a new tablet-based telerehabilitation app in patients with aphasia: a randomised, controlled, evaluator-blinded, multicentre trial protocol.

INTRODUCTION: Aphasia is a common language disorder acquired after stroke that reduces the quality of life of affected patients. The impairment is frequently accompanied by a deficit in cognitive functions. The state-of-the-art therapy is speech and language therapy but recent findings highlight positive effects of high-frequency therapy. Telerehabilitation has the potential to enable high-frequency therapy for patients at home. This study investigates the effects of high-frequency telerehabilitation speech and language therapy (teleSLT) on language functions in outpatients with aphasia compared with telerehabilitative cognitive training. We hypothesise that patients training with high-frequency teleSLT will show higher improvement in language functions and quality of life compared with patients with high-frequency tele-rehabilitative cognitive training (teleCT). METHODS AND ANALYSIS: This study is a randomised controlled, evaluator-blinded multicentre superiority trial comparing the outcomes following either high-frequency teleSLT or teleCT. A total of 100 outpatients with aphasia will be recruited and assigned in a 1:1 ratio stratified by trial site and severity of impairment to one of two parallel groups. Both groups will train over a period of 4 weeks for 2 hours per day. Patients in the experimental condition will devote 80% of their training time to teleSLT and the remaining 20% (24 min/day) to teleCT, vice versa for patients in the control condition. The primary outcome measure is the understandability of verbal communication on the Amsterdam Nijmegen Everyday Language Test and secondary outcome measures are intelligibility of the verbal communication, impairment of receptive and expressive language functions, confrontation naming. Other outcomes measures are quality of life and acceptance (usability and subjective experience) of the teleSLT system. ETHICS AND DISSEMINATION: This study is approved by the Ethics Committee Bern (ID 2016-01577). Results will be submitted to a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03228264.

Acceptance by laypersons and medical professionals of the personalized eHealth platform, eHealthMonitor.

INTRODUCTION AND BACKGROUND: Often, eHealth services are not accepted because of factors such as eHealth literacy or trust. Within this study, eHealthMonitor was evaluated in three European countries (Germany, Greece, and Poland) by medical professionals and laypersons with respect to numerous acceptance factors. METHODS: Questionnaires were created on the basis of factors from literature and with the help of scales which have already been validated. A qualitative survey was conducted in Germany, Poland, and Greece. RESULTS: The eHealth literacy of all participants was medium/high. Laypersons mostly agreed that they could easily become skillful with eHealthMonitor and that other people thought that they should use eHealthMonitor. Amongst medical professionals, a large number were afraid that eHealthMonitor could violate their privacy or the privacy of their patients. Overall, the participants thought that eHealthMonitor was a good concept and that they would use it. DISCUSSION AND CONCLUSION: The main hindrances to the use of eHealthMonitor were found in trust issues including data privacy. In the future, more research on the linkage of all measured factors is needed, for example, to address the question of whether highly educated people tend to mistrust eHealth information more than people with lower levels of education.

Usefulness of a Tailored eHealth Service for Informal Caregivers and Professionals in the Dementia Treatment and Care Setting: The eHealthMonitor Dementia Portal.

BACKGROUND: The European eHealthMonitor project (eHM) developed a user-sensitive and interactive Web portal for the dementia care setting called the eHM Dementia Portal (eHM-DP). It aims to provide targeted support for informal caregivers of persons with dementia and professionals. OBJECTIVE: The objective of this study was to assess the usefulness and impact of the eHM-DP service in the dementia care setting from two user perspectives: informal caregivers and professionals. METHODS: The evaluation study was conducted from June to September 2014 and followed a before-after, user-participatory, mixed-method design with questionnaires and interviews. The used intervention was the eHM-DP: an interactive Web portal for informal caregivers and professionals that was tested for a 12-week period. Primary outcomes for caregivers included empowerment, quality of life, caregiver burden, decision aid, as well as perceived usefulness and benefits of the eHM-DP. Primary outcomes for professionals involved decision aid, perceived usefulness, and benefits of the eHM-DP. RESULTS: A total of 25 informal caregivers and 6 professionals used the eHM-DP over the 12-week study period. Both professionals and informal caregivers indicated perceived benefits and support by the eHM-DP. In total, 65% (16/25) of informal caregivers would use the eHM-DP if they had access to it. Major perceived benefits were individualized information acquisition, improved interaction between informal caregivers and professionals, access to support from home, and empowerment in health-related decisions (PrepDM Score: 67.9). Professionals highlighted the improved treatment and care over the disease course (83%, 5/6) and improved health care access for people living in rural areas (67%, 4/6). However, there was no improvement in caregiver burden (Burden Scale for Family Caregivers) and quality of life (EuroQol-5D-5L) over the study period. CONCLUSIONS: Our study provides insight into the different user perspectives on an eHealth support service in the dementia treatment and care setting. These results are of importance for future developments and the uptake of eHealth solutions in the dementia domain and reinforce the importance of early user involvement. Turning to the primary target of the eHM-DP service, our findings suggest that the eHM-DP service proved to be a valuable post-diagnostic support service, in particular for the home-based care setting. Further research on a larger scale is needed to enhance the implementation in existing health care infrastructures.

Tailored e-Health services for the dementia care setting: a pilot study of 'eHealthMonitor'.

BACKGROUND: The European eHealthMonitor project (eHM) developed a user-sensitive and interactive web portal for dementia care: the eHM Dementia Portal (eHM-DP). It aims to provide targeted and personalized support for informal caregivers of people with dementia in a home-based care setting. The objective of the pilot study was to obtain feedback on the eHM-DP from two user perspectives (caregivers and medical professionals), focusing on caregiver empowerment, decision aid, and the perceived benefits of the eHM-DP. METHODS: The study on the eHM-DP was conducted from March 2014 to June 2014. The methodological approach followed a user-participatory design with a total number of 42 participants. The study included caregivers of people with dementia and medical professionals (MPs) from the metropolitan region of Erlangen-Nürnberg (Bavaria, Germany). Study participants were interviewed face-to-face with semi-structured, written interviews. RESULTS: Caregivers indicated a high degree of perceived support by the eHM-DP and of provided decision aid. In total, 89 % of caregivers and 54 % of MPs would use the eHM-DP if access were provided. The primary benefits participants perceived were the acquisition of individualized information, computerized interaction between caregivers and MPs, empowerment in health-related decisions and comprehensive insights into the progress of the disease. Major recommendations for improving the eHM-DP encompassed: an active search functionality based on predefined terms, the implementation of a chatroom for caregivers, an upload function and alerts for MPs, as well as the overall design. CONCLUSIONS: Our study is the first to have provided new insights and results on an interactive and needs-oriented web portal, endeavouring towards empowerment and assistance in decision making for caregivers as well as MPs within the realm of caring for patients with dementia. The acceptance and willingness to use the eHM-DP emphasizes the potential of eHealth services for community-based dementia care settings.

Recalls of cardiac implants in the last decade: what lessons can we learn?

BACKGROUND: Due to an ageing population and demographic changes worldwide, a higher prevalence of heart disease is forecasted, which causes an even higher demand for cardiac implants in future. The increasing high incidence of clinical adverse events attributed especially to high-risk medical devices has led an advocated change from many stakeholders. This holds especially true for devices like cardiac implants, with their high-risk nature and high complication rates associated with considerable mortality, due to their frequent use in older populations with frequent co-morbidities. To ensure patients' safety, the objective of this study is to analyze different cardiac implants recall reasons and different recall systems, based on an overview of the recalls of cardiac implant medical devices in the last decade. On the basis of the results from this structured analysis, this study provides recommendations on how to avoid such recalls from a manufacturer perspective, as well as how to timely react to an adverse event from a post-surveillance system perspective. METHODS AND FINDINGS: A systematic search of cardiac implant recalls information has been performed in the PubMed, ScienceDirect and Scopus databases, as well as data sources in regulatory authorities from 193 UN Member States. Data has been extracted for the years 2004-2014 with the following criteria applied: cardiac implant medical device recalls and reasons for recall, associated harm or risk to patients. From the data sources described above, eleven regulatory authorities and 103 recall reports have been included in this study. The largest cardiac implant categories include ICDs 40.8%, pacemakers 14.5% and stents 14.5%. Regarding the recall reasons, the majority of reports were related to device battery problems (33.0%) and incorrect therapy delivery (31.1%). From a total of 103 recall reports, five reported death and serious injuries. Our review highlights weaknesses in the current cardiac implant recall system, including data reporting and management issues and provides recommendations for the improvement of safety information and management. CONCLUSION: Due to the mortality associated with the nature of cardiac implants, the traceability and transparency of safety hazards information is crucial. By a structured analysis of recall reasons and their efficient management, important knowledge is gained to inform an effective safety-reporting system for monitoring the safety of cardiac implanted patients, ideally by building up cardiac implant registries worldwide in the future.

Exploring the perspectives and preferences for HTA across German healthcare stakeholders using a multi-criteria assessment of a pulmonary heart sensor as a case study.

BACKGROUND: Health technology assessment and healthcare decision-making are based on multiple criteria and evidence, and heterogeneous opinions of participating stakeholders. Multi-criteria decision analysis (MCDA) offers a potential framework to systematize this process and take different perspectives into account. The objectives of this study were to explore perspectives and preferences across German stakeholders when appraising healthcare interventions, using multi-criteria assessment of a heart pulmonary sensor as a case study. METHODS: An online survey of 100 German healthcare stakeholders was conducted using a comprehensive MCDA framework (EVIDEM V2.2). Participants were asked to provide i) relative weights for each criterion of the framework; ii) performance scores for a health pulmonary sensor, based on available data synthesized for each criterion; and iii) qualitative feedback on the consideration of contextual criteria. Normalized weights and scores were combined using a linear model to calculate a value estimate across different stakeholders. Differences across types of stakeholders were explored. RESULTS: The survey was completed by 54 participants. The most important criteria were efficacy, patient reported outcomes, disease severity, safety, and quality of evidence (relative weight >0.075 each). Compared to all participants, policymakers gave more weight to budget impact and quality of evidence. The quantitative appraisal of a pulmonary heart sensor revealed differences in scoring performance of this intervention at the criteria level between stakeholder groups. The highest value estimate of the sensor reached 0.68 (on a scale of 0 to 1, 1 representing maximum value) for industry representatives and the lowest value of 0.40 was reported for policymakers, compared to 0.48 for all participants. Participants indicated that most qualitative criteria should be considered and their impact on the quantitative appraisal was captured transparently. CONCLUSIONS: The study identified important variations in perspectives across German stakeholders when appraising a healthcare intervention and revealed that MCDA can demonstrate the value of a specified technology for all participating stakeholders. Better understanding of these differences at the criteria level, in particular between policymakers and industry representatives, is important to focus innovation aligned with patient health and healthcare system values and constraints.

The main cost drivers in dementia: a systematic review.

OBJECTIVES: Because of the increasing prevalence of dementia worldwide, combined with limited healthcare expenditures, a better understanding of the main cost drivers of dementia in different care settings is needed. METHODS: A systematic review of cost-of-illness (COI) studies in dementia was conducted from 2003 to 2012, searching the following databases: PubMed (Medline), Cochrane Library, ScienceDirect (Embase) and National Health Service Economic Evaluations Database. Costs (per patient) by care setting were analyzed for total, direct, indirect and informal costs and related to the following: (1) cost perspective and (2) disease severity. RESULTS: In total, 27 studies from 14 different healthcare systems were evaluated. In the included studies, total annual costs for dementia of up to $70,911 per patient (mixed setting) were estimated (average estimate of total costs = $30,554). The shares of cost categories in the total costs for dementia indicate significant differences for different care settings. Overall main cost drivers of dementia are informal costs due to home based long term care and nursing home expenditures rather than direct medical costs (inpatient and outpatient services, medication). CONCLUSIONS: The results of this review highlight the significant economic burden of dementia for patients, families and healthcare systems and thus are important for future health policy planning. The significant variation of cost estimates for different care settings underlines the need to understand and address the financial burden of dementia from both perspectives. For health policy planning in dementia, future COI studies should follow a quality standard protocol with clearly defined cost components and separate estimates by care setting and disease severity.

Clinical assessment of amyloid imaging in Alzheimer's disease: a systematic review of the literature.

BACKGROUND/AIMS: Healthcare systems face an increased prevalence of Alzheimer's disease and increasing costs. The use of molecular biomarkers and imaging could offer an effective solution for these issues. The objective of this study was to assess amyloid imaging regarding clinical utility and impact. METHODS: A literature search was performed in several databases, searching articles between 2008 and January 2013 following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The results are reported according to the clinical correlates of amyloid imaging. RESULTS: Thirty-three studies were included in the final analysis. Five studies evaluated amyloid imaging for diagnosis. Nine studies assessed the prognostic value. Twenty-two studies provided correlations to cognitive measures. Amyloid imaging provides a high reliability in diagnosis and prognosis, but cognitive measures only showed weak correlations. CONCLUSION: The evidence clearly indicated that amyloid imaging has not arrived yet in clinical practice. However, it can provide substantial benefits in special aspects of diagnostic accuracy and for a diagnosis up to 10 years before clinical diagnosis. This can be a base for early preventive treatment strategies such as anti-amyloid therapy. In this context, amyloid imaging is crucial to understand the early pathologic process in Alzheimer's disease.