[Integration of Inventory Data from Cohort and Registry Studies into an Existing Research Network: National Pandemic Cohort Network (NAPKON)]. / Integration von Bestandsdaten aus Kohorten- und Registerstudien in ein existierendes Forschungsnetzwerk: Nationales Pandemie Kohorten Netz (NAPKON).

In the early phase of the COVID-19 pandemic, many local collections of clinical data on patients infected with SARS-CoV-2 were initiated in Germany. As part of the National Pandemic Cohort Network (NAPKON) of the University Medicine Network, the "Integration Core" was established to design the legal, technical and organisational requirements for the integration of inventory data into ongoing prospective data collections and to test the feasibility of the newly developed solutions using use cases (UCs). Detailed study documents of the data collections were obtained. After structured document analysis, a review board evaluated the integrability of the data in NAPKON according to defined criteria. Of 30 university hospitals contacted, 20 responded to the request. Patient information and consent showed a heterogeneous picture with regard to the pseudonymised transfer of data to third parties and re-contact. The majority of the data collections (n=13) met the criteria for integration into NAPKON; four studies would require adjustments to the regulatory documents. Three cohorts were not suitable for inclusion in NAPKON. The legal framework for retrospective data integration and consent-free data use via research clauses (§27 BDSG) was elaborated by a legal opinion by TMF - Technology, Methods and Infrastructure for Networked Medical Research, Berlin. Two UCs selected by the NAPKON steering committee (CORKUM, LMU Munich; Pa-COVID-19, Charité- Universitätsmedizin Berlin) were used to demonstrate the feasibility of data integration in NAPKON by the end of 2021. Quality assurance and performance-based reimbursement of the cases were carried out according to the specifications. Based on the results, recommendations can be formulated for various contexts in order to create technical-operational prerequisites such as interoperability, interfaces and data models for data integration and to fulfil regulatory requirements on ethics, data protection, medical confidentiality and data access when integrating existing cohort data. The possible integration of data into research networks and their secondary use should be taken into account as early as the planning phase of a study - particularly with regard to informed consent - in order to maximise the benefits of the data collected.

Development of a Maturity Model for Medical Patient Registries - A Community Approach.

OBJECTIVE: Development of a generic model to visualize the potential for use and further development of registries to assess the suitability of the registry for a specific purpose. METHODS: Multi-stage community approach. RESULTS: The maturity model has 9 categories with 105 items. The purpose of the registry is mapped via potential usage dimensions. CONCLUSION: Important for acceptance is the appropriateness of the requirements in relation to the purposes.

General practitioners' perspectives on lifestyle interventions for cognitive preservation in dementia prevention.

BACKGROUND: General practitioners (GPs) play a crucial role in identifying cognitive impairment and dementia and providing post-diagnostic care. This study investigates (1) how promising GP consider lifestyle changes to maintain cognitive performance in general, (2) GP beliefs about the power of modifiable health and lifestyle factors to maintain cognitive performance, and (3) whether those beliefs vary by GP age. METHODS: As part of the AgeWell.de trial, GPs (n = 72) completed a process evaluation questionnaire assessing their perspectives on lifestyle changes to preserve cognitive performance in elderly patients. In greater detail, their perceived efficacy of established risk and protective factors was investigated using a 5-point Likert scale. Descriptive statistical analyses were performed for research question (1) and (2). Spearman´s rank correlations and ordinal logistic regressions were used to answer research question (3). All results were interpreted exploratively. RESULTS: GPs rated the overall chance of lifestyle changes maintaining cognitive performance quite neutral with a median score of 3.0 (IQR = 2.0). They rated the efficacy of all the modifiable health and lifestyle factors high, with increase in physical and social activity ((Mdn = 5.0, IQR = 1.0) receiving the highest ratings with the narrowest range. Spearman's rank correlation indicated a significant positive relationship between age and the belief in "Optimization of nutrition" for preventing cognitive decline and dementia (ρ = .255, p = .041). However, ordinal logistic regressions showed no significant relationships between age and GP ratings of lifestyle change efficacy. CONCLUSION: These findings highlight the positive perception of GPs on the efficacy of modifiable health and lifestyle factors for preventing cognitive decline and dementia. TRIAL REGISTRATION: The AgeWell.de trial is registered in the German Clinical Trials Register (DRKS; trial identifier: DRKS00013555, Registration Date 07 December 2017).

Clinical Outcomes and Cost-Effectiveness of Collaborative Dementia Care: A Secondary Analysis of a Cluster Randomized Clinical Trial.

Importance: Long-term evidence for the effectiveness and cost-effectiveness of collaborative dementia care management (CDCM) is lacking. Objective: To evaluate whether 6 months of CDCM is associated with improved patient clinical outcomes and caregiver burden and is cost-effective compared with usual care over 36 months. Design, Setting, and Participants: This was a prespecified secondary analysis of a general practitioner (GP)-based, cluster randomized, 2-arm clinical trial conducted in Germany from January 1, 2012, to December 31, 2014, with follow-up until March 31, 2018. Participants were aged 70 years or older, lived at home, and screened positive for dementia. Data were analyzed from March 2011 to March 2018. Intervention: The intervention group received CDCM, comprising a comprehensive needs assessment and individualized interventions by nurses specifically qualified for dementia care collaborating with GPs and health care stakeholders over 6 months. The control group received usual care. Main Outcomes and Measures: Main outcomes were neuropsychiatric symptoms (Neuropsychiatric Inventory [NPI]), caregiver burden (Berlin Inventory of Caregivers' Burden in Dementia [BIZA-D]), health-related quality of life (HRQOL, measured by the Quality of Life in Alzheimer Disease scale and 12-Item Short-Form Health Survey [SF-12]), antidementia drug treatment, potentially inappropriate medication, and cost-effectiveness (incremental cost per quality-adjusted life year [QALY]) over 36 months. Outcomes between groups were compared using multivariate regression models adjusted for baseline scores. Results: A total of 308 patients, of whom 221 (71.8%) received CDCM (mean [SD] age, 80.1 [5.3] years; 142 [64.3%] women) and 87 (28.2%) received usual care (mean [SD] age, 79.2 [4.5] years; 50 [57.5%] women), were included in the clinical effectiveness analyses, and 428 (303 [70.8%] CDCM, 125 [29.2%] usual care) were included in the cost-effectiveness analysis (which included 120 patients who had died). Participants receiving CDCM showed significantly fewer behavioral and psychological symptoms (adjusted mean difference [AMD] in NPI score, -10.26 [95% CI, -16.95 to -3.58]; P = .003; Cohen d, -0.78 [95% CI, -1.09 to -0.46]), better mental health (AMD in SF-12 Mental Component Summary score, 2.26 [95% CI, 0.31-4.21]; P = .02; Cohen d, 0.26 [95% CI, -0.11 to 0.51]), and lower caregiver burden (AMD in BIZA-D score, -0.59 [95% CI, -0.81 to -0.37]; P < .001; Cohen d, -0.71 [95% CI, -1.03 to -0.40]). There was no difference between the CDCM group and usual care group in use of antidementia drugs (adjusted odds ratio, 1.91 [95% CI, 0.96-3.77]; P = .07; Cramér V, 0.12) after 36 months. There was no association with overall HRQOL, physical health, or use of potentially inappropriate medication. The CDCM group gained QALYs (0.137 [95% CI, 0.000 to 0.274]; P = .049; Cohen d, 0.20 [95% CI, -0.09 to 0.40]) but had no significant increase in costs (437€ [-5438€ to 6313€] [US $476 (95% CI, -$5927 to $6881)]; P = .87; Cohen d, 0.07 [95% CI, -0.14 to 0.28]), resulting in a cost-effectiveness ratio of 3186€ (US $3472) per QALY. Cost-effectiveness was significantly better for patients living alone (CDCM dominated, with lower costs and more QALYs gained) than for those living with a caregiver (47 538€ [US $51 816] per QALY). Conclusions and Relevance: In this secondary analysis of a cluster randomized clinical trial, CDCM was associated with improved patient, caregiver, and health system-relevant outcomes over 36 months beyond the intervention period. Therefore, it should become a health policy priority to initiate translation of CDCM into routine care. Trial Registration: ClinicalTrials.gov Identifier: NCT01401582.

#consented - A semantic consent code to facilitate consistent documentation and implementation of consent in collaborative medical research.

INTRODUCTION: In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out to what extent data from these networks can be used for a specific research project. To make the contents of the consents queryable, we aimed for a permission-based approach (Opt-In) that can map both the permission and the withdrawal of consent contents as well as make it queryable beyond project boundaries. MATERIALS AND METHODS: The current state of research was analysed in terms of approach and reusability. Selected process models for defining consent policies were abstracted in a next step. On this basis, a standardised semantic terminology for the description of consent policies was developed and initially agreed with experts. In a final step, the resulting code was evaluated with regards to different aspects of applicability. RESULTS: A first and extendable version for a Semantic Consent Code (SCC) based on 3-axis (CLASS, ACTION, PURPOSE) was developed, consolidated und published. The added value achieved by the SCC was illustrated using the example of real consents from large national research associations (Medical Informatics Initiative and NUM NAPKON/NUKLEUS). The applicability of the SCC was successfully evaluated in terms of the manual semantic mapping of consents by briefly trained personnel and the automated interpretability of consent policies according to the SCC (and vice versa). In addition, a concept for the use of the SCC to simplify consent queries in heterogeneous research scenarios was presented. CONCLUSIONS: The Semantic Consent Code has already successfully undergone initial evaluations. As the published 3-axis code SCC is an essential preliminary work to standardising initially diverse consent texts and contents and can iteratively be extended in multiple ways in terms of content and technical additions. It should be extended in cooperation with the potential user community.

Effects of a multidomain intervention against cognitive decline on dementia risk profiles - Results from the AgeWell.de trial.

INTRODUCTION: Dementia risk scores constitute promising surrogate outcomes for lifestyle interventions targeting cognitive function. We investigated whether dementia risk, assessed using the LIfestyle for BRAin health (LIBRA) index, was reduced by the AgeWell.de intervention. METHODS: Secondary analyses of the AgeWell trial, testing a multicomponent intervention (including optimization of nutrition, medication, and physical, social, and cognitive activity) in older adults with increased dementia risk. We analyzed data from n = 461 participants with complete information on risk/protective factors comprised by LIBRA at the 24-month follow-up. Intervention effects on LIBRA and LIBRA components were assessed using generalized linear models. RESULTS: The intervention reduced LIBRA scores, indicating decreased dementia risk at follow-up (b = -0.63, 95% confidence interval [CI]: -1.14, -0.12). Intervention effects were particularly due to improvements in diet (odds ratio [OR]: 1.60, 95% CI: 1.16, 2.22) and hypertension (OR: 1.61, 95% CI: 1.19, 2.18). DISCUSSION: The AgeWell.de intervention reduced dementia risk. However, several risk factors did not improve, possibly requiring more intensive interventions. HIGHLIGHTS: The AgeWell.de intervention reduced dementia risk according to LIfestyle for BRAin health (LIBRA) scores. Beneficial effects on LIBRA are mainly due to changes in diet and blood pressure. A pragmatic lifestyle intervention is apt to reduce dementia risk in an at-risk population.

Adherence to a lifestyle intervention - just a question of self-efficacy? Analysis of the AgeWell.de-intervention against cognitive decline.

BACKGROUND: Aim of this study was to detect predictors of better adherence to the AgeWell.de-intervention, a two-year randomized multi-domain lifestyle intervention against cognitive decline. METHODS: Data of 317 intervention group-participants comprising a risk group for dementia (Cardiovascular Risk Factors, Ageing and Dementia (CAIDE) score of ≥ 9; mean age 68.9 years, 49.5% women) from the AgeWell.de intervention study were analysed. Regression models with four blocks of predictors (sociodemographic, cognitive and psychosocial, lifestyle factors and chronic conditions) were run on adherence to the components of nutrition, enhancement of social and physical activity and cognitive training. Adherence to each component was operationalised by assessing the degree of goal achievement per component at up to seven time points during the intervention period, measured using a 5-point Likert scale (mean score of goal achievement). RESULTS: Increasing age was negatively associated with adherence, while higher education positively predicted adherence. Participants with better mental state (Montreal Cognitive Assessment (MoCA)-score > 25) at baseline and higher self-efficacy adhered better. Diabetes and cardiovascular conditions were not associated with adherence, whereas smoking negatively affected adherence. Highest education and quitting smoking in the past were the only predictors associated with all four intervention components. CONCLUSION: Results identified predictors for better and worse adherence. Particularly self-efficacy seems to be of considerable influence on adherence. This should be considered when designing future intervention trials. TRIAL REGISTRATION: German Clinical Trials Register (ref. number: DRKS00013555).

Mediating Factors Associated With Physical Activity in Older Adults at Increased Dementia Risk.

While regular physical-activity (PA) is beneficial, multimorbid individuals at increased dementia risk may exhibit reduced PA levels. Thus, a more comprehensive understanding of mediating factors responsible for inactivity in this population is needed. This study investigated the impact of a multimodal intervention on PA changes at 24-month follow-up and associated mediating factors among community-dwelling patients aged 60-77, with increased dementia risk determined by the CAIDE Dementia Risk Score. Of 1030 participants recruited, 819 completed the assessment. Thus, a generalized estimating equations model initially assessed differences in PA over 24 months, followed by a tree analysis identifying mediating factors influencing PA changes post-intervention. While no significant effect on regular PA was found during the follow-up (P = .674), subgroup analysis revealed improved self-efficacy (P = .000) associated with increased engagement in PA. Incorporating self-efficacy elements into future strategies is crucial for promoting PA among individuals with multimorbidity and at increased dementia risk.

Healthcare Needs Patterns and Pattern-Predicting Factors in Dementia: Results of the Comprehensive, Computerized Unmet Needs Assessment from the Randomized, Controlled Interventional Trial InDePendent.

Background: Determining unmet need patterns and associated factors in primary care can potentially specify assessment batteries and tailor interventions in dementia more efficiently. Objective: To identify latent unmet healthcare need patterns and associated sociodemographic and clinical factors. Methods: This Latent Class Analysis (LCA) includes n = 417 community-dwelling people living with dementia. Subjects completed a comprehensive, computer-assisted face-to-face interview to identify unmet needs. One-hundred-fifteen predefined unmet medical, medication, nursing, psychosocial, and social care needs were available. LCA and multivariate logistic regressions were performed to identify unmet needs patterns and patient characteristics belonging to a specific pattern, respectively. Results: Four profiles were identified: [1] "few needs without any psychosocial need" (n = 44 (11%); mean: 7.4 needs), [2] "some medical and nursing care needs only" (n = 135 (32%); 9.7 needs), [3] "some needs in all areas" (n = 139 (33%); 14.3 needs), and [4] "many medical and nursing needs" (n = 99 (24%); 19.1 needs). Whereas the first class with the lowest number of needs comprised younger, less cognitively impaired patients without depressive symptoms, the fourth class had the highest number of unmet needs, containing patients with lower health status, less social support and higher comorbidity and depressive symptoms. Better access to social care services and higher social support reduced unmet needs, distinguishing the second from the third class (9.7 versus 14.3 needs). Conclusions: Access to the social care system, social support and depressive symptoms should be assessed, and the patient's health status and comorbidities monitored to more comprehensively identify unmet needs patterns and more efficiently guide tailored interventions.

Discrepancies between self- and proxy-rated quality of life in people living with dementia.

INTRODUCTION: The aim of this study was to analyze discrepancies between self- and proxy-rated health-related quality of life (HRQoL), measured with the EuroQol 5 Dimension 5 Level survey (EQ-5D-5L), in people living with dementia (PlwD) and their caregivers on an individual response level. METHODS: EQ-5D-5L, sociodemographic and clinical data were obtained from baseline data of n = 174 dyads of a cluster-randomized, controlled intervention trial. Self- and proxy-rated EQ-5D-5L health profiles were evaluated in terms of response distribution and agreement (weighted Kappa), and discrepancies in individual dimension level were analyzed using the Paretian Classification of Health Change (PCHC) as well as the presence and degree of inconsistencies between ratings. RESULTS: PlwD had a mean age of 80.1, nearly the half were female and 82.3% were mildly to moderately cognitively impaired. PlwD reported a higher utility index than caregiver proxies (mean 0.75 vs. 0.68, 83% of PlwD > 0.5). According to the PCHC and inconsistency approach, 95% of PlwD rated their health differently compared to proxies; 66% with divergent responses in at least three EQ-5D-5L dimensions. Nine dyads (5%) showed identical ratings. Discrepancies of one higher or lower EQ-5D-5L response represented the most frequent discrepancy (35.4%). Caregivers were two times more likely to report "moderate problems," representing the middle of the 5-point Likert scale. Usual activities had the lowest agreement between ratings (weighted kappa = 0.23). In PlwD reporting no or some problems in EQ-5D-5L-dimensions, proxies were more likely to report more problems and vice versa, especially in the more observable dimension usual activities and less likely in the less observable domains pain/discomfort and anxiety/depression. DISCUSSION: The central tendency bias observed in proxy-ratings could be associated with assessment uncertainties, resulting in an underestimation (overestimation) in PlwD reporting better (worse) health. This diverging trend extends the knowledge from previous studies and underlines the need for more methodological research in this area. Highlights: People living with dementia (PlwD) rate their health differently than proxies.Proxy-ratings over- or underestimate PlwD health when self-ratings are low or high.Proxies indicate a possible central tendency bias.Further research is needed to understand influencing factors.

Quality of life in a high-risk group of elderly primary care patients: characteristics and potential for improvement.

PURPOSE: Quality of Life (QoL) is associated with a bandwidth of lifestyle factors that can be subdivided into fixed and potentially modifiable ones. We know too little about the role of potentially modifiable factors in comparison to fixed ones. This study examines four aspects of QoL and its associations with 15 factors in a sample of elderly primary care patients with a high risk of dementia. The main objectives are (a) to determine the role of the factors in this particular group and (b) to assess the proportion of fixed and potentially modifiable factors. METHOD: A high-risk group of 1030 primary care patients aged between 60 and 77 years (52.1% females) were enrolled in "AgeWell.de," a cluster-randomized, controlled trial. This paper refers to the baseline data. The multi-component intervention targets to decrease the risk of dementia by optimization of associated lifestyle factors. 8 fixed and 7 modifiable factors potentially influencing QoL served as predictors in multiple linear regressions. RESULTS: The highest proportion of explained variance was found in psychological health and age-specific QoL. In comparison to health-related QoL and physical health, the modifiable predictors played a major role (corr. R2: 0.35/0.33 vs. 0.18), suggesting that they hold a greater potential for improving QoL. CONCLUSION: Social engagement, body weight, instrumental activities of daily living, and self-efficacy beliefs appeared as lifestyle factors eligible to be addressed in an intervention program for improving QoL. TRIAL REGISTRATION: German Clinical Trials Register, reference number: DRKS00013555. Date of registration: 07.12.2017.

Implementation of a telemedical urgency assessment procedure in the pediatric emergency room: evaluation results. / Implementation eines telemedizinischen Dringlichkeitseinschätzung-Verfahrens in der pädiatrischen Notaufnahme ­ Evaluationsergebnisse.

BACKGROUND: In rural areas in Germany, the number of emergency departments with pediatric expertise decreases. Telemedicine solutions are used sporadically, but they lack certain parameters for assessing a child's health status, such as touch and smell. We tested and evaluated the implementation of a telemedical, cross-hospital urgency assessment in pediatric emergency rooms. The telemedical urgency assessments were carried out via video conferences and were compared to the usual on-site procedure. Primary results of the concordance analysis have been published elsewhere. This work describes the results of the evaluation of the implementation. METHODS: The telemedical urgency assessment was carried out in 5 pediatric emergency departments during the years 2015-2019. Various methods were used to evaluate the implementation. The following reports are based on (a) a parent questionnaire with two statements to be evaluated (entire project duration), (b) a survey of the physicians using telemedicine after each case (entire project duration) and (c) detailed process documentation (July 2017 until end of the project). RESULTS: A total of 266 patients under 18 years old, recruited from four hospitals, were included in the study. (a) 210 parents completed the questionnaire. 78% of the parents felt adequately cared for and 70% could imagine telemedicine becoming established as a future supplementary care procedure. (b) The physicians' questionnaires for the telemedicine site were completed in 232 cases (87%). The average satisfaction rating was 1.8 on a 6-point-likert-scale (95% confidence interval: 1.64; 1.95). (c) The most frequent implementation problem concerned the technical implementation of the video conference. The evaluation of the accompanying documentation revealed in particular implementation barriers in the technical area (e. g. limited video and/or audio quality) and in the provision of human resources. CONCLUSION: Despite implementation barriers, the project showed that telemedical urgency assessment in acute pediatric care is a promising option for supporting care. Most of the participating clinicians needed a high level of support, which in some cases indicated a rather low level of digital competence. Increasing acceptance of telemedicine functionalities requires changes in society as a whole with improved framework conditions.

Informal Caregivers of People with Dementia in Germany: Psychosocial Characteristics and Unmet Needs.

Background: Caregivers of people with dementia living at home (CPwDh) are likely to be affected by a range of health problems. However, CPwDh are often regarded as accompanying persons and receive less attention in research and care. Little is known about this population and their needs in Germany. However, better knowledge of CPwDH is needed to design effective interventions. Objective: The objective of this report is to describe the situation of CPwDh and highlight differences based on sex and living situation. Methods: This was a cross-sectional analysis of the psychosocial characteristics of participants in the GAIN trial, a cluster-randomized, controlled intervention trial investigating the effectiveness of a care management program. A total of n = 192 CPwDh were recruited in GP offices, memory clinics or through public campaigns in the German federal state of Mecklenburg-Western Pomerania. The inclusion criteria were an age of 18 years or above, being a CPwDh, written informed consent. In a comprehensive digital assessment, psychosocial variables, burden, and care needs were assessed. Results: Partners, women, and people living in the same household represented the majority of caregivers, and their mean number of needs was 8.7. Overall, participants indicated a mild to moderate burden. There are differences in burden based on sex and living situation, with caregivers living with people with dementia showing less burden and different psychosocial demographics. Conclusions: There is a need for interventions to reduce caregivers' unmet needs in the CPwDh. Such interventions should consider differences in sex and living situation to better address individual caregiver needs.

Outpatient geriatric health care in the German federal state of Mecklenburg-Western Pomerania: a population-based spatial analysis of claims data.

BACKGROUND: Due to unidentified geriatric needs, elderly patients have a higher risk for developing chronic conditions and acute medical complications. Early geriatric screenings and assessments help to identify geriatric needs. Holistic and coordinated therapeutic approaches addressing those needs maintain the independence of elderly patients and avoid adverse effects. General practitioners are important for the timely identification of geriatric needs. The aims of this study are to examine the spatial distribution of the utilization of outpatient geriatric services in the very rural Federal State of Mecklenburg-Western Pomerania in the Northeast of Germany and to identify regional disparities. METHODS: Geographical analysis and cartographic visualization of the spatial distribution of outpatient geriatric services of patients who are eligible to receive basic geriatric care (BGC) or specialized geriatric care (SGC) were carried out. Claims data of the Association of Statutory Health Insurance Physicians in Mecklenburg-Western Pomerania were analysed on the level of postcode areas for the quarter periods between 01/2014 and 04/2017. A Moran's I analysis was carried out to identify clusters of utilization rates. RESULTS: Of all patients who were eligible for BGC in 2017, 58.3% (n = 129,283/221,654) received at least one BCG service. 77.2% (n = 73,442/95,171) of the patients who were eligible for SGC, received any geriatric service (BGC or SGC). 0.4% (n = 414/95,171) of the patients eligible for SGC, received SGC services. Among the postcode areas in the study region, the proportion of patients who received a basic geriatric assessment ranged from 3.4 to 86.7%. Several regions with statistically significant Clusters of utilization rates were identified. CONCLUSIONS: The widely varying utilization rates and the local segregation of high and low rates indicate that the provision of outpatient geriatric care may depend to a large extent on local structures (e.g., multiprofessional, integrated networks or innovative projects or initiatives). The great overall variation in the provision of BGC services implicates that the identification of geriatric needs in GPs' practices should be more standardized. In order to reduce regional disparities in the provision of BGC and SGC services, innovative solutions and a promotion of specialized geriatric networks or healthcare providers are necessary.

Factors Associated with Lower Social Activity in German Older Adults at Increased Risk of Dementia: A Cross-Sectional Analysis.

Background: Studies demonstrate associations between low social activity in older adults and cognitive decline. Little has been investigated regarding which factors are associated with low social activity in older adults at increased risk of dementia. Objective: We investigate which sociodemographic, psychological, health-related, and environmental factors are associated with low social activity in older adults at increased risk of dementia. Additionally, we describe the stages of health behavior change, the types of social activities, and the duration of the current level of social activity. Methods: We used baseline data of 1,015 participants from the AgeWell.de trial. We conducted logistic and Poisson regression analyses to investigate factors associated with low social activity. We report descriptive statistics on the stages of change in the sample, the types of social activities most frequently pursued, and the duration of the current level of social activity. Results: Lower income, non-usage of public transport, depressive symptoms, cognitive, mobility, and hearing impairment were negatively associated with social activity. The majority of the sample was in the maintenance stage, followed by the precontemplation stage. The most common social activities were traveling and hobbies with others. Participants have maintained their current level of social activity for several years. Conclusions: We identified a lack of resources (income, transport), depressive symptoms and poorer health (cognitive, mobility and hearing impairment) as barriers to social activity. Interventions promoting social activity in older adults at risk of dementia may specifically target individuals with these risk factors. Low-threshold opportunities for social activity may be particularly beneficial.

Sociodemographic and Clinical Characteristics of People Living with Dementia and Their Associations with Unmet Healthcare Needs: Insights from the Baseline Assessment of the InDePendent Study.

Background: The healthcare needs of People living with Dementia (PlwD) (such as Alzheimer's disease) are often unmet. Information about the needs of community-dwelling PlwD and their association with sociodemographic and clinical characteristics is needed to fill the knowledge gap regarding factors influencing unmet needs among PlwD and to conduct a comprehensive needs assessment to develop tailored interventions. Objective: To describe sociodemographic and clinical characteristics of the InDePendent study population with particular reference to determinants of unmet needs. Methods: We analyzed baseline data of the multi-centre cluster-randomized controlled trial (InDePendent) using descriptive statistics to describe patients' sociodemographic and clinical characteristics and Poisson regression models to predict unmet needs, separated by sex. Data were collected personally via face-to-face interviews. Results: Most of the n = 417 participating PlwD were mild to moderately cognitively impaired, were not depressed, had an average of 10.8 diagnoses, took 6.7 medications, and had, on average, 2.4 unmet needs (62% of PlwD had at least one unmet need) measured by the Camberwell Assessment of Need for the Elderly (CANE). Low social support, a high body-mass-index, a lower education, functional impairment, and worse health status were associated with more unmet needs, regardless of sex. In women, higher unmet needs were associated with more depressive symptoms, a poor financial situation, living alone and not being recently treated by a general practitioner. In males, unmet needs increased with the number of medications taken. Conclusions: PlwD had a broad array of unmet healthcare needs, indicating primary healthcare provision improvement potentials. The results underscore the significance of early assessment of patient's clinical characteristics and unmet needs as a basis for individualized gender-sensible intervention strategies.∥ClinicalTrials.gov Identifier: NCT04741932, Registered on February 5, 2021.

Physicochemical and Sensory Characterization of Whey Protein-Enriched Semihard Cheese.

In view of potential future changes of German food legislation with regard to cheese product quality parameters, this study aimed to evaluate the quality of whey protein-enriched semihard cheese (WPEC). Model WPEC was produced in a pilot plant and on an industrial scale by adding defined amounts of high-heat (HH) milk to the cheese milk and comprehensively analyzed during cheese processing. The dry matter, total protein, pure protein, fat, and sodium chloride content of six-week ripened cheese samples were not significantly different (p < 0.05) when the technologically necessary heating of the curd was adapted to the amount of HH milk. However, the ripening, firmness, and melting behavior of WPEC was different compared to cheese without HH milk. During ripening, no formation of whey protein peptides was observed, but differences in the amount of some bitter peptides deriving from the casein fraction were found. Sensory data suggested a slightly more bitter taste perception by the panelists for the WPEC. Further technological adjustments are recommended to obtain marketable WPEC.