Evaluation of a Digital Dementia Registry's IT Architecture After a Three-Year Period in Practice: digiDEM Bayern.

INTRODUCTION: The project "digiDEM Bayern" aims to set up a registry with long-term follow-up data on people with dementia and their family caregivers. For that purpose an Electronic Data Capture (EDC) system linked with a Participant Management (PM) system has been established. This study evaluates the acceptance and usability of the IT tools supporting all data management processes in order to further improve the system and associated processes. METHODS: For this purpose we collected the key numbers of the registry, and used the System Usability Scale (SUS) to evaluate the interactions of the data management systems in a wide area. RESULTS: Thirty-six research partners (RP) and six study team (ST) members completed the anonymous online survey. The EDC system overall reached an average SUS score of 73.42 and the PM system of 77.92. DISCUSSION: The two systems fulfil their required task and, therefore, simplify the work of the RP in the data collection process and of the ST during the data quality checks. CONCLUSION: Integrating the used systems is therefore recommended for registry studies in other medical areas.

Does Voluntary Work Contribute to Cognitive Performance? - An International Systematic Review.

Introduction: There is a need for knowledge on activities that can reduce cognitive decline and dementia risk. Volunteering is a productive activity that entails social, physical, and cognitive functions. Therefore, volunteering could be a protective factor for cognitive loss. Thus, this review aims to examine the associations between volunteering and volunteers' cognition and to identify influencing variables. Methods: Six international literature databases were searched for relevant articles published between 2017 and 2021 (ALOIS, CENTRAL, CINAL, Embase, PsycINFO, PubMed). Quantitative studies of all study designs were included. The primary outcome was the volunteers' cognition measured by objective, internationally established psychometric function tests. Two authors independently assessed the eligibility and quality of the studies. A narrative synthesis was performed using all studies included in this review. The methodology was in line with the PRISMA guidelines. Results: Fourteen studies met the inclusion criteria and were included. Seven of the included studies confirmed that volunteering positively affects the volunteers' cognitive function. Two other studies identified an association between volunteer activity and volunteers' cognition using cross-sectional measurements. In particular, women and people with a low level of education benefit from the positive effects and associations. The study quality of the included articles was moderate to weak. Discussion: Our review suggests that volunteering can improve volunteers' cognition. Unfortunately, little attention is given to specific volunteer activities and the frequency of engagement. Additionally, more attention is needed on various risk factors of cognitive impairment.

[Scientific evidence and user quality in mobile health applications for people with cognitive impairments and their caregivers]. / Wissenschaftliche Evidenz und Nutzerqualität von Mobile-Health-Anwendungen für Menschen mit kognitiven Beeinträchtigungen und deren Angehörige.

INTRODUCTION: The range of health-related apps is large, but the scientific evidence for them is uncertain. The aim of this study is to evaluate the methodological quality of German-language mobile health apps for people with dementia and their caregivers. METHODS: The app search was conducted according to the PRISMA-P guidelines in the application stores (Google Play Store and Apple App Store) using the terms "Demenz", "Alzheimer", "Kognition" and "Kognitive Beeinträchtigung". A systematic literature search with subsequent assessment of the scientific evidence was performed. The user quality assessment was conducted using "The German Version of the Mobile App Rating Scale" (MARS-G). RESULTS: Scientific studies have been published for only 6 of the 20 apps identified. A total of 13 studies were included in the evaluation, whereby the app itself was the subject of investigation in only two publications. In addition, methodological weaknesses were often observed such as small group sizes, short study duration and/or insufficient comparative treatment. The overall quality of the apps can be rated as acceptable with a mean MARS rating of 3.38. Seven apps were able to achieve a score of over 4.0 and thus a good rating, but just as many apps fell below the acceptable limit of 3.0. DISCUSSION: The contents of most apps have not been scientifically tested. This identified lack of evidence is consistent with the information in the literature in other indication areas. A systematic and transparent evaluation of health applications is necessary to protect end-users and better support their selection process.

[How robust are studies of currently permanently included digital health applications (DiGA)? Methodological quality of studies demonstrating positive health care effects of DiGA]. / Wie belastbar sind Studien der aktuell dauerhaft aufgenommenen digitalen Gesundheitsanwendungen (DiGA)? Methodische Qualität der Studien zum Nachweis positiver Versorgungseffekte von DiGA.

INTRODUCTION: Since September 2020 digital health applications (DiGA) can be prescribed by physicians and psychotherapists and are reimbursed within the German Statutory Health Insurance (SHI) system for the first time worldwide. For full reimbursement, the manufacturers have to provide evidence based on scientific studies that the DiGA can provide 'positive health care effects'. This study aims to analyze and evaluate the methodological quality of efficacy studies of DiGA in the categories 'Nervensystem' and 'Psyche' of the DiGA register that are permanently accepted. METHODS: The methodological quality was assessed using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2). The risk of bias was assessed for the primary endpoint of each study according to an intention-to-treat analysis. RESULTS: Six DiGA were assessed for their methodological quality. Randomized controlled trials were conducted for all 6 DiGA that showed a high risk of bias, which was, in particular, due to a lack of blinding of the studies. In addition, drop-outs were significantly higher in the intervention group than in the control group in most studies. For most of the DiGA no published study protocol was available in advance so an analysis of a potential selective choice of the evaluation methodology was not possible. DISCUSSION: For reasons of transparency, verifiability, and comprehensibility of the study results, registration in a study registry and, more importantly, the publication of study protocols should be mandatory before the start of the studies. In addition, studies should be blinded by comparing the DiGA with a 'sham application' to reduce the high risk of bias. Differences in the drop-out rates of the investigated studies could indicate a lack of efficacy of the treatment in the intervention group, (technical) problems in the application of the DiGA, or a lack of motivation of the participants. CONCLUSION: The interim results 18 months after the introduction of DiGA in the German SHI system show that the studies on the evidence of the benefits of DiGA have a high potential for bias in certain areas. However, it should be positively emphasized that the manufacturers submitted randomized controlled trials to prove the medical benefit of the DiGAs investigated.

The Dementia Assessment of Service Needs (DEMAND): Development and Validation of a Standardized Needs Assessment Instrument.

BACKGROUND: Dementia is one of the main triggers for care dependency among older adults who are predominantly cared for at home by relatives. To provide support in the care situation, health systems need valid information about the central needs of the affected people. OBJECTIVE: The present study aimed to develop a research instrument to assess the most important needs of people with dementia and their family caregivers. METHODS: The development of the 'Dementia Assessment of Service Needs (DEMAND)' took place within the project 'Digital Dementia Registry Bavaria (digiDEM Bayern)'. A focus group and an online survey with dementia experts were conducted to identify the most relevant support services and to develop the design of the instrument. The questionnaire was deployed in the digiDEM baseline data collection. Participants were asked to evaluate the comprehensibility of the questionnaire. Readability was assessed using the Flesch reading ease score. RESULTS: Seventeen experts participated in the focus group and 59 people in the online survey. The final questionnaire included 13 support services. One hundred eighty-three participants (50 people with dementia and 133 family caregivers) completed the questionnaire at baseline. The mean comprehensibility score was 3.6 (SD = 2.3). The Flesch reading ease score result was 76. CONCLUSION: A research instrument could be developed, enabling people with dementia and family caregivers to directly express their individual needs for specific support services. Results show that the DEMAND is easy to understand and short in execution. Therefore, supply gaps can be identified and transformed into a specific health care plan.

The effects of exercise programs on cognition, activities of daily living, and neuropsychiatric symptoms in community-dwelling people with dementia-a systematic review.

BACKGROUND: The prevalence of dementia is expected to increase dramatically. Due to a lack of pharmacological treatment options for people with dementia, non-pharmacological treatments such as exercise programs have been recommended to improve cognition, activities of daily living, and neuropsychiatric symptoms. However, inconsistent results have been reported across different trials, mainly because of the high heterogeneity of exercise modalities. Thus, this systematic review aims to answer the questions whether exercise programs improve cognition, activities of daily living as well as neuropsychiatric symptoms in community-dwelling people with dementia. METHODS: Eight databases were searched for articles published between 2016 and 2021 (ALOIS, CENTRAL, CINAHL, Embase, MEDLINE, PsycINFO, PubMed, Web of Science). Randomized controlled trials evaluating the effects of any type of physical activity on cognition, activities of daily living, or neuropsychiatric symptoms in community-dwelling people with a formal diagnosis of dementia were included in this systematic review. Two authors independently assessed eligibility and quality of the studies. The methodology was in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. RESULTS: Eight publications covering seven trials were included in this review with the majority investigating either a combination of strength and aerobic exercise or aerobic exercise alone. This review revealed that there is no clear evidence for the beneficial effects of exercise on cognition. None of the included trials found an impact on activities of daily living. Although different randomized controlled trials reported inconsistent results, one trial indicated that especially aerobic exercise may improve neuropsychiatric symptoms. CONCLUSION: Our systematic review did not confirm the impact of exercise on cognition and activities of daily living in community-dwelling people with dementia. The results suggested that aerobic exercise might be effective to reduce neuropsychiatric symptoms. Well-designed trials including only community-dwelling people with a formal diagnosis of dementia, large samples, long-term follow-ups, and detailed description of adherence to the intervention are needed to improve the scientific evidence on the best type of exercise modality. TRIAL REGISTRATION: PROSPERO, CRD42021246598 .

Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern.

BACKGROUND: Registries are an essential research tool to investigate the long-term course of diseases and their impact on the affected. The project digiDEM Bayern will set up a prospective dementia registry to collect long-term data of people with dementia and their caregivers in Bavaria (Germany) supported by more than 300 research partners. OBJECTIVE: The objective of this article is to outline an information technology (IT) architecture for the integration of a registry and comprehensive participant management in a dementia study. Measures to ensure high data quality, study governance, along with data privacy, and security are to be included in the architecture. METHODS: The architecture was developed based on an iterative, stakeholder-oriented process. The development was inspired by the Twin Peaks Model that focuses on the codevelopment of requirements and architecture. We gradually moved from a general to a detailed understanding of both the requirements and design through a series of iterations. The experience learned from the pilot phase was integrated into a further iterative process of continuous improvement of the architecture. RESULTS: The infrastructure provides a standardized workflow to support the electronic data collection and trace each participant's study process. Therefore, the implementation consists of three systems: (1) electronic data capture system for Web-based or offline app-based data collection; (2) participant management system for the administration of the identity data of participants and research partners as well as of the overall study governance process; and (3) videoconferencing software for conducting interviews online. First experiences in the pilot phase have proven the feasibility of the framework. CONCLUSION: This article outlines an IT architecture to integrate a registry and participant management in a dementia research project. The framework was discussed and developed with the involvement of numerous stakeholders. Due to its adaptability of used software systems, a transfer to other projects should be easily possible.

eHealth Interventions for Dementia - Using WordPress Plugins as a Flexible Dissemination for Dementia Service Providers.

The benefits of eHealth interventions for people with dementia and their informal caregivers have been demonstrated in several studies. In times of contact restrictions, digital solutions have become increasingly important, especially for people with dementia and their mostly elderly caregiving relatives, which are at increased risk of severe illness from COVID-19. As in many other health areas, there is a lack of digital interventions in the dementia landscape that are successfully implemented (i.e., put into practice), especially digital interventions that are scientifically evaluated. Evaluated and proven effective digital interventions exist, but these often do not find their way from research into practice and stay on low-level implementation readiness. Within the project digiDEM Bayern, a digital platform with digital services and interventions for people affected by dementia (people with dementia, caregivers, volunteers and interested citizens) is established. As one digital intervention for informal caregivers, the 'Angehörigenampel' (caregivers' traffic-light) was developed, which is able to assess the physical and psychological burden of caregivers. This can help to counteract the health effects of caregiving burden early on before it is too late. The development of the digital intervention as a WordPress-plugin was kept generic so that it can easily be adapted to other languages on further websites. The 'intervention as a plugin' approach demonstrates an easy and flexible way of deploying eHealth interventions to other service providers, especially from other countries. The implementation barriers for other service providers are low enough for them to be able to easily integrate the eHealth intervention on their website, enabling more caregivers to benefit from the disseminated eHealth intervention.

Exploring physicians and patients' perspectives for current interventions on thyroid nodules using a MCDA method.

BACKGROUND: The detection of thyroid cancer has rapidly increased over last few decades without an increase in disease specific mortality. Several studies claim that the diagnose of thyroid nodules through routine ultrasound imaging is often the trigger for cascade effects leading to unnecessary follow-up over many years or to invasive treatment. The objective of this study was to explore physicians' and patients' insights and preferences regarding the current interventions on thyroid nodules. METHODS: An online survey was developed using a comprehensive multi-criteria decision analysis (MCDA) framework, the EVIdence based Decision-Making (EVIDEM). The EVIDEM core model used in this study encompassed 13 quantitative criteria and four qualitative criteria. Participants were asked to provide weights referring to what matters most important in general for each criterion, performance scores for appraising the interventions on thyroid nodules and their consideration of impact of contextual criteria. Normalized weights and standardized scores were combined to calculate a value contribution across all participants, additionally differences across physicians and patients' group were explored. RESULTS: 48 patients and 31 physicians were included in the analysis. The value estimate of the interventions on thyroid nodules reached 0.549 for patients' group and 0.5 was reported by the physicians' group, compared to 0.543 for all participants. The highest value contributor was 'Comparative effectiveness' (0.073 ± 0.020). For the physicians' group, 'Comparative safety' (0.050 ± 0.023) was given with higher value. And for the patients' group, 'Type of preventive benefits' (0.059 ± 0.022) contributed more positively to the value estimation. 51% participants considered 'Population priorities and access' having a negative impact on the interventions of nodules.66% participants thought that the 'system capacity' had a negative impact. CONCLUSION: Our study shows participants' preferences on each criterion, i.e., physician indicated keeping the interventions safe and effective more important, patients indicated quality of life after receiving interventions more important. Through comparison among participants, differences have been highlighted, which can make better communication between physicians and patients. This study provides a supportive decision-making for healthcare providers when they explored the interventions on thyroid nodules.

Predictors of the one-year-change in depressiveness in informal caregivers of community-dwelling people with dementia.

BACKGROUND: The care of people with dementia is usually carried out by their family members, which can cause objective und subjective burden and raise their risk of depressiveness. Thus, the aim of this study is to identify predictors of the change in depressiveness of informal caregivers over 1 year in order to be able to derive hypotheses for interventions that promise success. METHODS: The Bavarian Dementia Survey (BayDem) is a multi-center, longitudinal study conducted at three different sites in Bavaria, Germany. Participants were people with dementia and their informal caregivers. Data was collected at baseline and after 12 months by standardized face-to-face interviews in cooperation with local players. The informal caregivers' depressiveness was assessed with the WHO-5. Data was also collected on the people with dementia's cognition (MMSE), behavioral symptoms (NPI) and comorbidities (Charlson Comorbidity Index) as well as caregivers' social inclusion (LSNS), time spent on care and care contribution (RUD). For statistical analysis, a multiple regression model was used. RESULTS: The data of 166 people with dementia and their informal caregivers was analyzed. Of the latter, 46% were categorized as "likely depressed". The change in depressiveness over a year was significantly predicted by baseline depressiveness as well as an increase in the time informal caregivers spent supervising the person with dementia. CONCLUSIONS: Informal caregivers of people with dementia are at high risk of depression. The time spent supervising the person with dementia has a significant impact on increasing depressiveness. This highlights the importance of support services to provide the informal caregiver with relief and possibly reduce depressiveness.

Digital Dementia Registry Bavaria-digiDEM Bayern: study protocol for a multicentre, prospective, longitudinal register study.

INTRODUCTION: Dementia is one of the most relevant widespread diseases, with a prevalence of currently 50 million people with dementia worldwide. The care of people with dementia will be one of the major challenges for healthcare systems worldwide. Digitalisation offers new possibilities to improve both dementia healthcare and health outcomes research as a fundament for national healthcare planning. The 'Digital Dementia Registry Bavaria-digiDEM Bayern' aims to improve the understanding of the complexity and long-term progression of dementia and the current care situation in Bavaria. Moreover, by offering digital services, digiDEM will actively contribute to improving the care situation in Bavaria. METHODS AND ANALYSIS: digiDEM will recruit people with dementia and their family caregivers in all administrative regions of Bavaria. All participants will undergo dementia screening prior to study inclusion in order to identify people with mild cognitive impairment and mild-to-moderate dementia. Participants will be followed up over a period of three years. Sociodemographic data, type of dementia, symptoms, diagnosis, cognitive trajectories, activities of daily living, behavioural and psychological symptoms, falls, resource utilisation, caregiver burden, quality of life, needs of people with dementia and their caregivers, mobility, use of media and sources of information will be assessed. The project will implement a digital web-based platform for data collection. Data will be collected by means of standardised online or face-to-face interviews. ETHICS AND DISSEMINATION: The study obtained ethical approval from the Ethics Committee of the Medical Faculty of Friedrich-Alexander-University Erlangen-Nürnberg (FAU) (application number: 253_20 B). Findings will be used for evidence-based decision-making for health decision-makers in order to optimise dementia healthcare in the state of Bavaria. Specific analyses will be conducted for the participating research partners. Results of the study will be published in peer-reviewed journals.

Twenty-Year Time Trends in Long-Term Case-Fatality and Recurrence Rates After Ischemic Stroke Stratified by Etiology.

BACKGROUND AND PURPOSE: Data on long-term survival and recurrence after stroke are lacking. We investigated time trends in ischemic stroke case-fatality and recurrence rates over 20-years stratified by etiological subtype according to the Trial of ORG 10172 in Acute Stroke Treatment classification within a population-based stroke register in Germany. METHODS: Data was collected within the Erlangen Stroke Project, a prospective, population-based stroke register covering a source population of 105 164 inhabitants (2010). Case fatality and recurrence rates for 3 months, 1 year, and 5 years were estimated with Kaplan-Meier estimates. Sex-specific time trends for case-fatality and recurrence rates were estimated with Cox regression. We adjusted for age, sex, and year of event and stratified for etiological subtypes. A sensitivity analysis with competing risk analysis for time trends in recurrence were performed. RESULTS: Between 1996 and 2015, 3346 patients with first ischemic stroke were included; age-standardized incidence per 100 000 was 75.8 in women and 131.6 in men (2015). Overall, 5-year survival probabilities were 50.4% (95% CI, 47.9-53.1) in women and 59.2% (95% CI, 56.4-62.0) in men; 5-year survival was highest in patients with first stroke due to small-artery occlusion (women, 71.8% [95% CI, 67.1-76.9]; men, 75.9% [95% CI, 71.3-80.9]) and lowest in cardioembolic stroke (women, 35.7% [95% CI, 31.0-41.1]; men, 47.8% [95% CI, 42.2-54.3]). Five-year recurrence rates were 20.1% (95% CI, 17.5-22.6) in women and 20.1% (95% CI, 17.5-22.7) in men; 5-year recurrence rate was lowest in women in stroke due to small artery occlusion 16.0% (95% CI, 11.7-20.1) and in men in large-artery atherosclerosis 16.6% (95% CI, 8.7-23.9); highest risk of recurrence was observed in undefined strokes (women, 22.3% [95% CI, 17.8-26.6]; men, 21.4% [95% CI, 16.7-25.9]). Cox regression revealed improvements in case-fatality rates over time with differences in stroke causes. No time trends in recurrence rates were observed. CONCLUSIONS: Long-term survival and recurrence varied substantially by first stroke cause. Survival probabilities improved over the past 2 decades; no major trends in stroke recurrence rates were observed.

Stakeholder Perspectives on the Key Components of a Digital Service Platform Supporting Dementia - digiDEM Bayern.

The increasing number of people with dementia and caregiving relatives will require a change in the provision of dementia-related services in the future. Digital technologies are a force for change. The new project digiDEM Bayern with its digital services on a digital platform and a digital patient registry should help to improve the situation for people with dementia and their caregivers especially in rural settings. An online survey among service providers for people with dementia and caregiving relatives in Bavaria was conducted to find out how they assess the current landscape of digital and non-digital service offers for people with dementia and their caregivers. The results of the survey have revealed that there is currently a large gap in the provision of digital services varying between the different categories surveyed. digiDEM Bayern addresses this gap with its digital dementia-related service platform.

Cardiac implant registries 2006-2016: a systematic review and summary of global experiences.

OBJECTIVES: The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006-2016) and to provide recommendations on 'best practice' approaches. SETTINGS AND PARTICIPANTS: A systematic search on CIR was employed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect and the Scopus database, EMBASE. After identifying the existing CIRs, an aggregative approach will be used to explore key elements emerging in the identified registries. RESULTS: The following 82 registries were identified: 18 implantable cardioverterdefibrillator (ICD) registries, 7 cardiac resynchronisation therapy (CRT) registries, 5 pacemaker registries and 6 cardiovascular implantable electronic device registries which combined ICD, pacemaker and CRT implantation data; as well as 22 coronary stent registries and 24 transcatheteraortic heart valve implantation registries. While 71 national or local registries are from a single country, 44 are from European countries and 9 are located in USA. The following criteria have been summarised from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis. CONCLUSIONS: Registries provide a 'real-world' picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and therefore approval issues of the medical device; for payers CIRs provide evidence on the medical device benefit and drive the decision whether the product should be reimbursed or not; for hospitals CIRs' data are important for sound procurement decisions, and CIRs also help patients and their physicians to joint decision-making which of the products is the most appropriate.

Health economic evaluations of non-pharmacological interventions for persons with dementia and their informal caregivers: a systematic review.

BACKGROUND: This systematic review aims to review the literature on trial-based economic evaluations of non-pharmacological interventions directly targeted at persons with dementia as well as persons with mild cognitive impairment and their respective caregivers. METHODS: A systematic literature research was conducted for the timeframe from 2010 to 2016 in the following databases: Centre for Reviews and Dissemination, EconLit, Embase, Cochrane Library, PsycINFO and PubMed. Study quality was assessed according to the Drummond criteria. RESULTS: In total sixteen publications were identified. Health economic evaluations indicated the cost-effectiveness of physical exercise interventions and occupational therapy. There was also evidence to suggest that psychological and behavioral therapies are cost-effective. Health economic studies investigating psychosocial interventions mainly targeted towards informal caregivers showed inconsistent results. CONCLUSIONS: Due to the increasing prevalence of dementia non-pharmacological interventions and their health economic impact are of increasing importance for health care decision-makers and HTA agencies.

Diagnosis of cognitive decline and dementia in rural areas - A scoping review.

OBJECTIVES: Due to the demographic change, the global prevalence of dementia will continually rise. Barriers to diagnosis and care are still high. But timely diagnosis is associated with valuable benefits and can promote timely and optimal management. Receiving an early diagnosis is especially in rural areas a problem due to the limited access to assessments. Therefore, the aim of our scoping review is to investigate different interventions targeted at rural living elderly to screen and diagnose cognitive decline and dementia. METHODS: A scoping review was conducted in line with the framework of Arksey and O'Malley. The following databases were systematically searched: PubMed, PsycINFO, Cochrane Library, and ScienceDirect. The interventions were categorized in four main categories (interventions for general practitioners/institutions; online/mobile offers; telehealth applications; telephone-based screenings). RESULTS: Thirty studies were included. The four categories show different scopes of application. Telehealth applications show that it is feasible and valid to diagnose dementia via videoconference. Assessments described in three other categories show that remotely used tools are appropriate to screen for mild cognitive impairment or cognitive decline, but are not valid to establish a dementia diagnosis. CONCLUSIONS: Telehealth applications can appropriately be used to diagnose dementia. However, most of the studies included only small sample sizes and did not test the applications explicitly in rural or remote populations. Therefore, studies taking these limitations into account are needed. On top, only two RCTs are included in this review indicating that more high quality studies in this field are needed.

Advance Directives as Support of Autonomy for Persons with Dementia? A Pilot Study among Persons with Dementia and Their Informal Caregivers.

BACKGROUND: Advance directives could be an important instrument to support a person's will once he/she is not able to consent anymore - if composed competently. A survey was conducted to identify the level of knowledge concerning possibilities and limits of advance directives. METHODS: The study was conducted as part of the Bavarian Dementia Survey (BayDem). Data were collected from January 2014 to December 2015 by structured face-to-face interviews. Study participants were persons with dementia and their informal caregivers (n = 74). RESULTS: In total, 66% reported having written an advance directive. Concerning the participants' knowledge about possibilities and limitations of advance directives, a lack of knowledge was noted about the possibility to revoke an advance directive. Furthermore, 70% of informal caregivers and 56% of persons with dementia were not aware of the possibility to include dementia-specific terms in the advance directive. CONCLUSION: It is necessary to optimize structures for public information and education concerning the topic of advance directives for persons with dementia.

Incidence and relative risk of stroke in the diabetic and the non-diabetic population between 1998 and 2014: A community-based stroke register.

One major objective of the St. Vincent Declaration was to reduce excess risk of stroke in people with diabetes mellitus. The aim of this study is to estimate the trend of incidence and relative risk of stroke in the diabetic and the non-diabetic populations in Germany over a 17-year period. We estimated age-sex standardised incidence rates of all stroke and ischaemic stroke in people with and without diabetes based on an ongoing prospective community-based stroke register covering 105,000 inhabitants. Time trends were analysed using Poisson regression. In total, 3,111 individuals (diabetes: 28.4%, men 46.9%, mean age 73.1 years (SD 13.2)) had a first stroke, 84.9% of which were ischaemic stroke. Among people with diabetes we observed a significant reduction in all stroke incidence by 1.5% per year (relative risk: 0.985; 95% confidence interval 0.972-0.9995) Likewise, this incidence tended to decrease for ischaemic stroke by 1% per year (0.993; 0.979-1.008). In contrast, the incidence rate for all stroke remained nearly stable among people without diabetes (1.003; 0.993-1.013) and for ischaemic stroke (1.002; 0.991-1.013). The relative risk comparing diabetic and non-diabetic population decreased for all stroke (two percent annual reduction) but not for ischaemic stroke. Time trends were similar for both sexes regarding all and ischaemic strokes. We found a reduction in risk of stroke in the diabetic population while this rate did not materially change in the non-diabetic population.

How TAVI registries report clinical outcomes-A systematic review of endpoints based on VARC-2 definitions.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for severe aortic stenosis in patients considered as high surgical risk. Since its first human implantation by Cribier et al., TAVI has been shown to increase survival rate and quality of life for high surgical risks patients. The objective of this study is to provide an overview of TAVI registries and the reporting clinical outcomes based on the VARC-2 definitions. In addition, the comparability and adherence of VARC-2 reporting within the identified TAVI registries was reviewed. MATERIALS AND METHODS: A systematic review of TAVI registries reporting VARC-2 definitions has been performed in line with PRISMA guidelines in PubMed, ScienceDirect, Scopus databases and EMBASE. Based on VARC-2, patients' characteristics and procedure characteristics, 30-day clinical outcomes, 1-year mortality and composited endpoints were extracted from each registry's publications. RESULTS: This review identified 466 studies that were potentially relevant, and 20 TAVI registries reported VARC-2 definitions involved in our present review. Of all 20 registries, an overall sample size of 12,583 patients was involved. The 30-day all-cause mortality ranged from 0 to 12.7%. From 20 registries, 14 registries reported the cardiovascular mortality at 30 days. 9 registries reported myocardial infarction (MI) rate based on VARC-2 definitions, and 7 registries reported peri-procedural MI rate (<72h). In our review, most of registries presented MI rates ranging from 0.5% to 2%. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation. CONCLUSION: Since the introduction of VARC definitions from 2011, VARC and VARC-2 definitions are still not systematically used by all TAVI studies. These endpoint definitions warrant a concise and systemic analysis of outcome measures. Reporting TAVI-outcome uniformly makes study result comparison feasible. This definitely will increase patient safety, additionally to provide sufficient evidence to support decision makers like regulatory bodies, HTA agencies, payers.