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.

[Travel time to memory clinics in Bavaria: A geographical analyses within the framework of digiDEM Bayern]. / Räumliche Erreichbarkeit von Gedächtnisambulanzen ­ Eine geographische Analyse im Rahmen von digiDEM Bayern.

BACKGROUND: Memory clinics can contribute significantly to a qualified diagnosis of dementia. Since the accessibility of medical facilities is an important predictor for their utilisation, the aim of this study was to determine the accessibility of memory clinics for persons with dementia in Bavaria. METHODS: We used a Geographic Information System (GIS) to determine travel times to the nearest memory clinic for all Bavarian municipalities based on OpenStreetMap road network data. RESULTS: The majority of the modelled persons with dementia in Bavaria (40%; n = 93,950) live in communities with an average travel time of 20 to 40 minutes to the nearest memory clinic. Almost 7,000 (3%) require more than one hour. Especially persons from rural communities have to travel significantly longer distances than people from urban areas. CONCLUSION: In view of demographic developments, there is an urgent need for memory clinics to be accessible throughout the country for all persons with dementia, regardless of where they live. The systematic development of memory clinics in areas with long travel times or the establishment of mobile diagnostic services could help to improve dementia care.

[Can nursing home placement of people with dementia be delayed by case management? A Systematic Review of Randomized Controlled Trials]. / Kann Case Management den Umzug von Menschen mit Demenz in eine Pflegeeinrichtung verzögern? ­ Ein systematisches Review randomisiert kontrollierter Studien.

BACKGROUND: Dementia is one of the main reasons for care dependency in old age. Demographic changes will lead to decreased formal and informal care potential in Germany. The promotion of structured home care arrangements therefore becomes increasingly significant. The concept of case management (CM) aims at the efficient coordination of health care services based on the needs and resources of patients with chronic health issues and their caregivers. The objective of this review was to evaluate current studies on the effectiveness of outpatient CM approaches on delaying long-term care placement or reducing the risk of long-term care placement in people with dementia. METHODS: A systematic literature review of randomized controlled trials (RCTs) was conducted. Relevant electronic databases (Pubmed, CINAHL, PsycINFO, Scopus, CENTRAL, Gerolit, ALOIS) were systematically searched. Reporting and study quality was assessed using the CONSORT checklist and Jadad scale. RESULTS: The search strategies identified 6 RCTs relating to 5 different health care systems (Germany, USA, Netherlands, France, China). Three of the RCTs showed significant delays of long-term care placements and/or significantly reduced rates of long-term care placement in favor of the intervention groups. CONCLUSION: The outcomes suggest that CM approaches have the potential of promoting the length of time that people with dementia remain in their own domestic environments. Further establishment and evaluation of CM approaches should therefore be strongly encouraged on the part of healthcare decision-makers. When planning and evaluating CM approaches, specific barriers, and resources for the sustainable implementation of CM in existing care chains should be assessed and taken into account.

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.

Health Technology Assessment-Informed Decision Making by the Federal Joint Committee/Institute for Quality and Efficiency in Health Care in Germany and the National Institute for Health and Care Excellence in England: The Role of Budget Impact.

OBJECTIVES: This study aimed to test (official) evaluation criteria including the potential role of budget impact (BI) on health technology assessment (HTA) outcomes published by the Federal Joint Committee (Gemeinsamer Bundesausschuss [GBA]) and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) in Germany as well as the National Institute for Health and Care Excellence (NICE) in England. METHODS: Data were extracted from all publicly available GBA decisions and IQWiG assessments as well as NICE single technology appraisals between January 2011 and June 2018, and information with regard to evaluation criteria used by these agencies was collected. Data were analyzed using logistic regression to estimate the effect of the BI on the HTA outcomes while controlling for criteria used by GBA/IQWiG and NICE. RESULTS: NICE recommendations are largely driven by the incremental cost-effectiveness ratio and, if applicable, by end-of-life criteria (P < .01). While IQWiG assessments are significantly affected by the availability of randomized controlled trials and patient-relevant endpoints (P < .01), GBA appraisals primarily focus on endpoints (P < .01). The BI correlated with NICE single technology appraisals (inverted-U relationship, P < .1) and IQWiG recommendations (increasing linear relationship, P < .05), but not with GBA decisions (P > .1). Nevertheless, given that IQWiG assessments seem to be more rigorous than GBA appraisals regarding the consideration of evidence-based evaluation criteria, decisions by GBA might be negatively associated with the BI. CONCLUSIONS: Results reveal that GBA/IQWiG and NICE follow their official evaluation criteria consistently. After controlling for all significant variables, the BI seems to have an (independent) effect on HTA outcomes as well.

[Advance Directives and Palliative Medical Care in Nursing Homes: A Study on Everyday Life and Relevance in Out-of-Hours Medical Care]. / Patientenverfügungen und palliative ärztliche Versorgung in Pflegeheimen ­ Studie zu Alltag und Relevanz außerhalb regulärer Praxiszeiten.

BACKGROUND: The percentage of nursing home residents that have documented advance directives (AD) is increasing. However, there are no studies concerning the consideration of these directives within the out-of-hours primary care or the emergency service. There is also a lack of information on the differences in the attitudes of doctors on duty in various disciplines towards therapeutic options in palliative situations. METHODS: In the context of research about the medical care of nursing home residents outside regular practice hours, the existence of AD and their consideration by the doctors on duty or emergency doctors was investigated (n=101). Furthermore, the attitudes of the doctors on duty (n=60) and of a reference group of palliative doctors (n=19) towards experience in palliative medicine, asking for AD of the patients and the approach in a fictive palliative case were recorded. RESULTS: 71% of the 82 residents had documented a living will. In 54% of the 101 cases, the doctors on duty and emergency doctorsmade enquiries about AD. In 92% of cases, the doctors followed the given directives. Significant differences between doctors on duty and emergency doctors could not be confirmed. Given a fictive palliative case, 92% of the doctors on duty and 95% of the reference group stated they would enquire about an AD. In acute palliative situations, general practitioners, internists and palliative physicians were more likely to use rapid-acting opioids and anxiolytics, were less likely to call the emergency doctor and were less likely to admit patients to hospital. This distinguishes them from other disciplines. CONCLUSIONS: In only 54% of all contacts between patient and doctors on duty or emergency doctors, enquiries were about an AD. That is why doctors need to be further sensitized on the issue of making enquiries about AD from unknown. Additionally, the patient's will should be visible in short form in the respective patient file. Arrangements made with foresight, early involvement of doctors with palliative experience (AAPV, SAPV) as well as increased palliative medical training could improve the care of nursing home residents.

[Current Evidence for Assessing Fitness to Drive of People with Cognitive Impairment: A Systematic Review]. / Aktuelle Evidenzlage zur Beurteilung der Fahrtauglichkeit von Menschen mit kognitiven Einschränkungen: Ein systematisches Review.

BACKGROUND: Assessment of driving ability in people with cognitive impairment is a topic of great social relevance due to the high prevalence of dementia. METHODS: A comprehensive systematic literature review was conducted on the research question, "Which evidence-based methods are suitable for assessing the fitness to drive of people with dementia or mild cognitive impairment?" for the period 2015-2020. The search was conducted in the Medline, PsycINFO, LIVIVO, PubPsych, Scopus, Cinahl, and CENTRAL databases. RESULTS: Thirty studies were included in the qualitative analysis. Driving ability can be assessed with practice-based testing procedures such as On-road Driving, Simulator, and Naturalistic Driving. Theory-based methods include neuropsychological testing, driving-specific testing, and self-assessment questionnaires. Studies show that single neuropsychological tests are not sufficient to determine fitness to drive. Practice-based test procedures, driving-specific tests, and combinations of evidence-based methods have a higher informative value. CONCLUSIONS: In view of the progressive course of dementia, the assessment of driving ability of people with cognitive impairment should be performed in a close-meshed way by a combination of theory- and practice-based methods.

[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 .

Prediction of Recurrent Ischemic Stroke Using Registry Data and Machine Learning Methods: The Erlangen Stroke Registry.

BACKGROUND: There have been multiple efforts toward individual prediction of recurrent strokes based on structured clinical and imaging data using machine learning algorithms. Some of these efforts resulted in relatively accurate prediction models. However, acquiring clinical and imaging data is typically possible at provider sites only and is associated with additional costs. Therefore, we developed recurrent stroke prediction models based solely on data easily obtained from the patient at home. METHODS: Data from 384 patients with ischemic stroke were obtained from the Erlangen Stroke Registry. Patients were followed at 3 and 12 months after first stroke and then annually, for about 2 years on average. Multiple machine learning algorithms were applied to train predictive models for estimating individual risk of recurrent stroke within 1 year. Double nested cross-validation was utilized for conservative performance estimation and models' learning capabilities were assessed by learning curves. Predicted probabilities were calibrated, and relative variable importance was assessed using explainable artificial intelligence techniques. RESULTS: The best model achieved the area under the curve of 0.70 (95% CI, 0.64-0.76) and relatively good probability calibration. The most predictive factors included patient's family and housing circumstances, rehabilitative measures, age, high calorie diet, systolic and diastolic blood pressures, percutaneous endoscopic gastrotomy, number of family doctor's home visits, and patient's mental state. CONCLUSIONS: Developing fairly accurate models for individual risk prediction of recurrent ischemic stroke within 1 year solely based on registry data is feasible. Such models could be applied in a home setting to provide an initial risk assessment and identify high-risk patients early.

Usability Evaluation of an Offline Electronic Data Capture App in a Prospective Multicenter Dementia Registry (digiDEM Bayern): Mixed Method Study.

BACKGROUND: Digital registries have been shown to provide an efficient way of gaining a better understanding of the clinical complexity and long-term progression of diseases. The paperless method of electronic data capture (EDC) during a patient interview saves both time and resources. In the prospective multicenter project "Digital Dementia Registry Bavaria (digiDEM Bayern)," interviews are also performed on site in rural areas with unreliable internet connectivity. It must be ensured that EDC can still be performed in such a context and that there is no need to fall back on paper-based questionnaires. In addition to a web-based data collection solution, the EDC system REDCap (Research Electronic Data Capture) offers the option to collect data offline via an app and to synchronize it afterward. OBJECTIVE: The aim of this study was to evaluate the usability of the REDCap app as an offline EDC option for a lay user group and to examine the necessary technology acceptance of using mobile devices for data collection. The feasibility of the app-based offline data collection in the digiDEM Bayern dementia registry project was then evaluated before going live. METHODS: An exploratory mixed method design was employed in the form of an on-site usability test with the "Thinking Aloud" method combined with an online questionnaire including the System Usability Scale (SUS). The acceptance of mobile devices for data collection was surveyed based on five categories of the technology acceptance model. RESULTS: Using the "Thinking Aloud" method, usability issues were identified and solutions were accordingly derived. Evaluation of the REDCap app resulted in a SUS score of 74, which represents "good" usability. After evaluating the technology acceptance questionnaire, it can be concluded that the lay user group is open to mobile devices as interview tools. CONCLUSIONS: The usability evaluation results show that a lay user group generally agree that data collecting partners in the digiDEM project can handle the REDCap app well. The usability evaluation provided statements about positive aspects and could also identify usability issues relating to the REDCap app. In addition, the current technology acceptance in the sample showed that heterogeneous groups of different ages with diverse experiences in handling mobile devices are also ready for the use of app-based EDC systems. Based on these results, it can be assumed that the offline use of an app-based EDC system on mobile devices is a viable solution for collecting data in a decentralized registry-based research project.

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.