Study protocol of the HessenKohorte2042: a prospective, longitudinal cohort study characterising quality of life in people with Parkinson's disease and their caregivers using a bio-psycho-social approach.

INTRODUCTION: Quality of life (QoL) is of paramount importance as an outcome to monitor and guide therapies for people with Parkinson's disease (PwPD). In particular, due to the heterogeneous symptoms that PwPD may experience during their disease course, QoL can deteriorate not only in patients but also in their caregivers, with a variety of psychosocial consequences. However, there is a lack of longitudinal studies that explore how QoL evolves over time and what factors are significant. Furthermore, holistic approaches that consider bio-psycho-social determinants are rare. In the worst cases, these gaps can lead to suboptimal care and therefore unmet needs for patients and their caregivers, resulting in unnecessary symptom burden and increased healthcare costs for society. METHODS AND ANALYSIS: This prospective, longitudinal study will follow 1000 PwPD along with their caregivers for 20 years, with up to 40 semi-annual assessments. Patient data and sample collection will include clinical assessments, self-reported outcome measures focusing on QoL, biospecimen collection and MRI. Caregiver burden will be systematically assessed through self-administered questionnaires. The use of digitised surveys will allow efficient data collection and convenient assessment at home. Our primary objective is to attain a holistic understanding of QoL in PwPD and establish a tool to measure it. The secondary objective is to explore the psycho-social and biological variables associated with QoL of patients and caregivers over the progression of the disease. This will provide key information for diagnostic and prognostic prediction, therapeutic patient stratification and adaptation of therapy in the future. ETHICS AND DISSEMINATION: The study was approved by the local ethics committee of the University Hospital of Marburg (study number: 209/19). The results will be disseminated by means of publication in peer-reviewed journals, international conference contributions, annual patient meetings and a dedicated website. TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00023598).

Long-term effects of a telemedically-assisted lifestyle intervention on glycemic control in patients with type 2 diabetes - A two-armed randomised controlled trial in Germany.

Purpose: Diabetes is considered one of the fastest growing diseases worldwide. Especially in the treatment of type 2 diabetes, lifestyle interventions have proven to be effective. However, long-term studies in real-world contexts are rare, which is why further research is needed. The aim of the present study is to investigate whether effects achieved in the context of a long-term lifestyle intervention can be sustained by patients in the long term. Methods: In a two-arm randomized trial we compared diabetes care as usual to a lifestyle intervention combining telemedically support and individual needs-based telephone coaching. The study included 151 patients with type 2 diabetes randomized to either the intervention or control group. Intervention Group (IG; N = 86, 80.2% male, mean age: 59.7) received telemedical devices and telephone coaching over a period of 12 months, Control Group (CG; N = 65, 83.1% male, mean age: 58,8) received care as usual. The primary outcome was chance in HbA1c. A follow-up survey was conducted after 24 months. Results: The intervention group showed significantly better HbA1c- values compared to the control group at both 12 and 24 months (12 M: - 0.52 (-0.73; - 0.32), p < .000; 24 M: - 0.38 (-0.61; - 0.15), p = .001). The strongest change was seen in the first three months, with the best value obtained at 6 months and stable thereafter. Conclusion: Combined telephone coaching with telemedicine support could lead to better long-term glycemic control in people with type 2 diabetes. In the future, more long-term studies should be conducted in real-world settings and lifestyle interventions should be offered more widely.

[Ethical Considerations of Including Minors in Clinical Trials Using the Example of the Indicated Prevention of Psychotic Disorders]. / Minderjährige in klinischen Prüfungen: Ethische Abwägungen ihres Einbezugs am Beispiel der indizierten Prävention psychotischer Erkrankungen.

Ethical Considerations of Including Minors in Clinical Trials Using the Example of the Indicated Prevention of Psychotic Disorders Abstract: As a vulnerable group, minors require special protection in studies. For this reason, researchers are often reluctant to initiate studies, and ethics committees are reluctant to authorize such studies. This often excludes minors from participating in clinical studies. This exclusion can lead to researchers and clinicians receiving only incomplete data or having to rely on adult-based findings in the treatment of minors. Using the example of the study "Computer-Assisted Risk Evaluation in the Early Detection of Psychotic Disorders" (CARE), which was conducted as an 'other clinical investigation' according to the Medical Device Regulation, we present a line of argumentation for the inclusion of minors which weighs the ethical principles of nonmaleficence (especially regarding possible stigmatization), beneficence, autonomy, and fairness. We show the necessity of including minors based on the development-specific differences in diagnostics and early intervention. Further, we present specific protective measures. This argumentation can also be transferred to other disorders with the onset in childhood and adolescence and thus help to avoid excluding minors from appropriate evidence-based care because of insufficient studies.

Prediction of depressive symptoms at high age (80+) by psychological, biological and functional factors.

BACKGROUND: Late-life depression (LLD) is highly prevalent, especially in people aged 80 years and older. We aimed to investigate predictors and their influence on depressive symptoms in LLD. METHODS: We analysed data from the NRW80+ study, a population-based cross-sectional study of individuals aged 80 years and older. Data from n = 926 cognitively unimpaired participants were included. We reduced 95 variables to 21 predictors of depressive symptoms by using a two-step cluster analysis (TSCA), which were assigned to one of four factors (function, values and lifestyle, autonomy and contentment, biological-somatic) according to a principal component analysis. A second TSCA with complete data sets (n = 879) was used to define clusters of participants. Using weighted mean composite scores (CS) for each factor group, binary logistic regression analyses were performed to predict depressive symptoms for each cluster and the total population. RESULTS: The second TSCA yielded two clusters (cluster 1 (n = 688), cluster 2 (n = 191)). The proportion of participants with depressive symptoms was significantly higher in cluster 2 compared to cluster 1 (39 % vs. 15 %; OR = 3.6; 95 % CI 2.5-5.1; p < .001). Participants in cluster 2 were significantly older (mean age 88 vs. 85 years; p < .001), with a higher proportion of women (56 % vs. 46 %; OR = 1.5; 95 % CI 1.1-2.0; p = .016), had a higher BMI (p = .017), lower financial resources (OR = 2.3; 95 % CI 1.6-3.5; p < .001), lower educational level (OR = 1.8; 95 % CI 1.2-2.5; p = .002), higher proportion of single, separated or widowed participants (OR = 1.9; 95 % CI 1.3-2.6; p < .001) and a smaller mean social network (p = .044) compared to cluster 1. Binary logistic regression analyses showed that the weighted mean CS including the autonomy and contentment predictors explained the largest proportion of variance (22.8 %) for depressive symptoms in the total population (Nagelkerke's R2 = 0.228, p < .001) and in both clusters (cluster 1: Nagelkerke's R2 = 0.171, p < .001; cluster 2: Nagelkerke's R2 = 0.213, p < .001), respectively. LIMITATIONS: The main limitations are the restriction to cognitively unimpaired individuals and the use of a self-rated questionnaire to assess depressive symptoms. CONCLUSIONS: Psychological factors such as autonomy and contentment are critical for the occurrence of depressive symptoms at higher age, independent of the functional and somatic status and may serve as specific targets for psychotherapy.

Interventions for improving health literacy in migrants.

BACKGROUND: Health literacy (HL) is a determinant of health and important for autonomous decision-making. Migrants are at high risk for limited HL. Improving HL is important for equitable promotion of migrants' health. OBJECTIVES: To assess the effectiveness of interventions for improving HL in migrants. To assess whether female or male migrants respond differently to the identified interventions. SEARCH METHODS: We ran electronic searches to 2 February 2022 in CENTRAL, MEDLINE, Embase, PsycInfo and CINAHL. We also searched trial registries. We used a study filter for randomised controlled trials (RCTs) (RCT classifier). SELECTION CRITERIA: We included RCTs and cluster-RCTs addressing HL either as a concept or its components (access, understand, appraise, apply health information). DATA COLLECTION AND ANALYSIS: We used the methodological procedures recommended by Cochrane and followed the PRISMA-E guidelines. Outcome categories were: a) HL, b) quality of life (QoL), c) knowledge, d) health outcomes, e) health behaviour, f) self-efficacy, g) health service use and h) adverse events. We conducted meta-analysis where possible, and reported the remaining results as a narrative synthesis. MAIN RESULTS: We included 28 RCTs and six cluster-RCTs (8249 participants), all conducted in high-income countries. Participants were migrants with a wide range of conditions. All interventions were adapted to culture, language and literacy. We did not find evidence that HL interventions cause harm, but only two studies assessed adverse events (e.g. anxiety). Many studies reported results for short-term assessments (less than six weeks after total programme completion), reported here. For several comparisons, there were also findings at later time points, which are presented in the review text. Compared with no HL intervention (standard care/no intervention) or an unrelated HL intervention (similar intervention but different information topic) Self-management programmes (SMP) probably improve self-efficacy slightly (standardised mean difference (SMD) 0.28, 95% confidence interval (CI) 0.06 to 0.50; 2 studies, 333 participants; moderate certainty). SMP may improve HIV-related HL (understanding (mean difference (MD) 4.25, 95% CI 1.32 to 7.18); recognition of HIV terms (MD 3.32, 95% CI 1.28 to 5.36)) (1 study, 69 participants). SMP may slightly improve health behaviours (3 studies, 514 participants), but may have little or no effect on knowledge (2 studies, 321 participants) or subjective health status (MD 0.38, 95% CI -0.13 to 0.89; 1 study, 69 participants) (low certainty). We are uncertain of the effects of SMP on QoL, health service use or adverse events due to a lack of evidence. HL skills building courses (HLSBC) may improve knowledge (MD 10.87, 95% CI 5.69 to 16.06; 2 studies, 111 participants) and any generic HL (SMD 0.48, 95% CI 0.20 to 0.75; 2 studies, 229 participants), but may have little or no effect on depression literacy (MD 0.17, 95% CI -1.28 to 1.62) or any health behaviour (2 studies, 229 participants) (low certainty). We are uncertain if HLSBC improve QoL, health outcomes, health service use, self-efficacy or adverse events, due to very low-certainty or a lack of evidence. Audio-/visual education without personal feedback (AVE) probably improves depression literacy (MD 8.62, 95% CI 7.51 to 9.73; 1 study, 202 participants) and health service use (MD -0.59, 95% CI -1.11 to -0.07; 1 study, 157 participants), but probably has little or no effect on health behaviour (risk ratio (RR) 1.07, 95% CI 0.91 to 1.25; 1 study, 135 participants) (moderate certainty). AVE may improve self-efficacy (MD 3.51, 95% CI 2.53 to 4.49; 1 study, 133 participants) and may slightly improve knowledge (MD 8.44, 95% CI -2.56 to 19.44; 2 studies, 293 participants) and intention to seek depression treatment (MD 1.8, 95% CI 0.43 to 3.17), with little or no effect on depression (SMD -0.15, 95% CI -0.40 to 0.10) (low certainty). No evidence was found for QoL and adverse events. Adapted medical instruction may improve understanding of health information (3 studies, 478 participants), with little or no effect on medication adherence (MD 0.5, 95% CI -0.1 to 1.1; 1 study, 200 participants) (low certainty). No evidence was found for QoL, health outcomes, knowledge, health service use, self-efficacy or adverse events. Compared with written information on the same topic SMP probably improves health numeracy slightly (MD 0.7, 95% CI 0.15 to 1.25) and probably improves print literacy (MD 9, 95% CI 2.9 to 15.1; 1 study, 209 participants) and self-efficacy (SMD 0.47, 95% CI 0.3 to 0.64; 4 studies, 552 participants) (moderate certainty). SMP may improve any disease-specific HL (SMD 0.67, 95% CI 0.27 to 1.07; 4 studies, 955 participants), knowledge (MD 11.45, 95% CI 4.75 to 18.15; 6 studies, 1101 participants) and some health behaviours (4 studies, 797 participants), with little or no effect on health information appraisal (MD 1.15, 95% CI -0.23 to 2.53; 1 study, 329 participants) (low certainty). We are uncertain whether SMP improves QoL, health outcomes, health service use or adverse events, due to a lack of evidence or low/very low-certainty evidence. AVE probably has little or no effect on diabetes HL (MD 2, 95% CI -0.15 to 4.15; 1 study, 240 participants), but probably improves information appraisal (MD -9.88, 95% CI -12.87 to -6.89) and application (RR 1.51, 95% CI 1.29 to 1.77) (1 study, 608 participants; moderate certainty). AVE may slightly improve knowledge (MD 8.35, 95% CI -0.32 to 17.02; low certainty). No short-term evidence was found for QoL, depression, health behaviour, self-efficacy, health service use or adverse events. AVE compared with another AVE We are uncertain whether narrative videos are superior to factual knowledge videos as the evidence is of very low certainty. Gender differences Female migrants' diabetes HL may improve slightly more than that of males, when receiving AVE (MD 5.00, 95% CI 0.62 to 9.38; 1 study, 118 participants), but we do not know whether female or male migrants benefit differently from other interventions due to very low-certainty or a lack of evidence. AUTHORS' CONCLUSIONS: Adequately powered studies measuring long-term effects (more than six months) of HL interventions in female and male migrants are needed, using well-validated tools and representing various healthcare systems.

Patient-centered empirical research on ethically relevant psychosocial and cultural aspects of cochlear, glaucoma and cardiovascular implants - a scoping review.

BACKGROUND: The significance of medical implants goes beyond technical functioning and reaches into everyday life, with consequences for individuals as well as society. Ethical aspects associated with the everyday use of implants are relevant for individuals' lifeworlds and need to be considered in implant care and in the course of technical developments. METHODS: This scoping review aimed to provide a synthesis of the existing evidence regarding ethically relevant psychosocial and cultural aspects in cochlear, glaucoma and cardiovascular implants in patient-centered empirical research. Systematic literature searches were conducted in EBSCOhost, Philpapers, PsycNET, Pubmed, Web of Science and BELIT databases. Eligible studies were articles in German or English language published since 2000 dealing with ethically relevant aspects of cochlear, glaucoma and passive cardiovascular implants based on empirical findings from the perspective of (prospective) implant-wearers and their significant others. Following a descriptive-analytical approach, a data extraction form was developed and relevant data were extracted accordingly. We combined a basic numerical analysis of study characteristics with a thematically organized narrative synthesis of the data. RESULTS: Sixty-nine studies were included in the present analysis. Fifty were in the field of cochlear implants, sixteen in the field of passive cardiovascular implants and three in the field of glaucoma implants. Implant-related aspects were mainly found in connection with autonomy, freedom, identity, participation and justice, whereas little to no data was found with regards to ethical principles of privacy, safety or sustainability. CONCLUSIONS: Empirical research on ethical aspects of implant use in everyday life is highly relevant, but marked by ambiguity and unclarity in the operationalization of ethical terms and contextualization. A transparent orientation framework for the exploration and acknowledgment of ethical aspects in "lived experiences" may contribute to the improvement of individual care, healthcare programs and research quality in this area. Ethics-sensitive care requires creating awareness for cultural and identity-related issues, promoting health literacy to strengthen patient autonomy as well as adjusting healthcare programs accordingly. More consideration needs to be given to sustainability issues in implant development and care according to an approach of ethics-by-design.

Patient Preferences for Long-Term Implant Care in Cochlear, Glaucoma and Cardiovascular Diseases.

In the process of developing and implementing innovative implant technologies the consideration of patient preferences can be beneficial for patients, doctors and developers. Nevertheless, in existing literature, there is still scarce knowledge of patients' perspectives on long-term implant care. In this study, three discrete choice experiments (DCEs) were conducted in the context of cochlear implants (CI, n = 92), glaucoma implants (GI, n = 21) and cardiovascular implants (CVI, n = 23), examining the relative importance of attributes of long-term implant care from the patients' perspective. The participants chose between differently shaped options for implant-related care. The attributes of these care options were generated and selected based on previous literature reviews, group discussions and a diary study with patients. The choice data were analyzed via binary logit regression. In CI-DCE, the technological compatibility of the implant with newer implant models, accessories or devices from other manufacturers was highly valued by participants, whereas in GI-DCE the (in)dependency on glaucoma medication post-implantation had the greatest influence on participants' choice behavior. In CVI-DCE, the attribute with the highest relative importance related to the means of securing long-term treatment success. In all three DCE, shared decision making was relatively important for participants. Our results emphasized the importance of an adequate transfer of technological advancements in implant care for promoting patient benefits, such as the availability of comprehensible, understandable, high-quality information about current developments. Similarly, promoting technological health literacy and further pushing the technological compatibility, durability and safety of implants are directions for future implant development in accordance with patients' preferences. Therefore, the participation of implant wearers in the development process is encouraged.

Ethical considerations for precision psychiatry: A roadmap for research and clinical practice.

Precision psychiatry is an emerging field with transformative opportunities for mental health. However, the use of clinical prediction models carries unprecedented ethical challenges, which must be addressed before accessing the potential benefits of precision psychiatry. This critical review covers multidisciplinary areas, including psychiatry, ethics, statistics and machine-learning, healthcare and academia, as well as input from people with lived experience of mental disorders, their family, and carers. We aimed to identify core ethical considerations for precision psychiatry and mitigate concerns by designing a roadmap for research and clinical practice. We identified priorities: learning from somatic medicine; identifying precision psychiatry use cases; enhancing transparency and generalizability; fostering implementation; promoting mental health literacy; communicating risk estimates; data protection and privacy; and fostering the equitable distribution of mental health care. We hope this blueprint will advance research and practice and enable people with mental health problems to benefit from precision psychiatry.

Risk-Adjusted Cancer Screening and Prevention (RiskAP): Complementing Screening for Early Disease Detection by a Learning Screening Based on Risk Factors.

Background: Risk-adjusted cancer screening and prevention is a promising and continuously emerging option for improving cancer prevention. It is driven by increasing knowledge of risk factors and the ability to determine them for individual risk prediction. However, there is a knowledge gap between evidence of increased risk and evidence of the effectiveness and efficiency of clinical preventive interventions based on increased risk. This gap is, in particular, aggravated by the extensive availability of genetic risk factor diagnostics, since the question of appropriate preventive measures immediately arises when an increased risk is identified. However, collecting proof of effective preventive measures, ideally by prospective randomized preventive studies, typically requires very long periods of time, while the knowledge about an increased risk immediately creates a high demand for action. Summary: Therefore, we propose a risk-adjusted prevention concept that is based on the best current evidence making needed and appropriate preventive measures available, and which is constantly evaluated through outcome evaluation, and continuously improved based on these results. We further discuss the structural and procedural requirements as well as legal and socioeconomical aspects relevant for the implementation of this concept.

Health Literacy in the Context of Implant Care-Perspectives of (Prospective) Implant Wearers on Individual and Organisational Factors.

The continuous development of medical implants offers various benefits for persons with chronic conditions but also challenges an individual's, and the healthcare system's, ability to deal with technical innovation. Accessing and understanding new information, navigating healthcare, and appraising the role of the implant in body perceptions and everyday life requires health literacy (HL) of those affected as well as an HL-responsive healthcare system. The interconnectedness of these aspects to ethically relevant values such as health, dependence, responsibility and self-determination reinforces the need to address HL in implant care. Following a qualitative approach, we conducted group discussions and a diary study among wearers of a cochlear, glaucoma or cardiovascular implant (or their parents). Data were analysed using the documentary method and grounded theory. The data reveal the perceptions of implant wearers regarding the implant on (1) the ability to handle technical and ambiguous information; (2) dependence and responsibility within the healthcare system; and (3) the ethical aspects of HL. Knowing more about the experiences and values of implant wearers is highly beneficial to develop HL from an ethical perspective. Respective interventions need to initially address ethically relevant values in counselling processes and implant care.

The Deep Brain Stimulation Impairment Scale: A useful complement in assessment of well-being and functioning in DBS-patients - Results from a large multicentre survey in patients with Parkinson's disease.

BACKGROUND: Deep Brain Stimulation (DBS) has been proven to alleviate motor symptoms in Parkinson's Disease (PD). Regarding non-motor symptoms, however, inconsistencies have been reported, on whether DBS causes reductions in well-being and functioning. To assess motor and non-motor impairment in DBS-patients, the Deep Brain Stimulation Impairment Scale (DBS-IS) has been developed. Yet, the extent to which the DBS-IS detects impairment in DBS-patients and thus could serve as a useful tool that complements the PDQ-39 (gold standard) in assessment of well-being and functioning in PD-patients has not been shown. OBJECTIVES: By comparing DBS and non-DBS-patients we aimed to identify DBS-specific symptoms. We thereby aimed to show in how far the DBS-IS complements the PDQ-39 in assessing well-being and functioning in PD patients under DBS. METHODS: In a cross-sectional study, 186 DBS-patients were matched (for age, disease duration and sex) to 186 non-DBS-patients (N = 372) and the two groups were compared regarding well-being and functioning: Impairment was assessed via DBS-IS and overall Quality of Life (QoL) was assessed via PDQ-39. Additionally, we analyzed differences in impairment between age and disease duration clusters. RESULTS: DBS-patients showed significantly higher total impairment (DBS-IS) and significantly higher impairment on the subscales Postural Instability and Gait difficulties and speaking difficulties than non-DBS-patients. Impairment increased with age and disease duration and, overall, differences in impairment rose by age. Overall QoL (PDQ-39) was non-significantly lower in DBS-patients. CONCLUSION: Since there is evidence that the PDQ-39 misses some DBS-specific symptoms, the DBS-IS is recommended to complement the PDQ-39 when assessing DBS-patients.

Development of a Multidimensional Assessment Tool for the Evaluation of Holistic Quality of Life in Parkinson's Disease.

BACKGROUND: Parkinsonian syndromes are heterogeneous chronic neurodegenerative disorders associated with both motor and non-motor symptoms. The symptoms have major psychosocial effects on the quality of life of patients and can be a burden for caregivers. So far, several questionnaires have been developed to assess quality of life in Parkinsonism, but none of these include the positive sides on well-being such as personal and social resilience factors. OBJECTIVE: The aim of this study is to develop a digital framework for a longitudinal assessment of quality of life during the progression of Parkinson's disease. METHODS: The CHAPO model (Challenges and Potentials) has been established in a vast study by Wagner et al. to assess the quality of life of older people. This model includes environmental and individual factors, life chances, and life results, such as individual life evaluation, from a subjective as well as an objective point of view. Therefore, it has been adapted in several development steps to include the specific aspects that affect quality of life in Parkinsonian syndromes. The development process included 6 steps: definition, refinement, operationalization, piloting/debriefing, adjustment, and integration. RESULTS: The development of the CHAPO-PD model has been completed and it represents the first main result of this study. CONCLUSION: By taking a holistic understanding of quality of life into account, we expect to detect previously unrecognized factors, which correlate to the subjective well-being of Parkinson's disease patients, and aim to use these findings to improve the health care structures for patients with Parkinson's disease and related disorders.

Gender differences of health literacy in persons with a migration background: a systematic review and meta-analysis.

OBJECTIVE: To investigate gender differences of health literacy in individuals with a migration background. DESIGN: Systematic review and meta-analysis. OVID/MEDLINE, PsycINFO and CINAHL were searched in March 2018 and July 2020. SETTING: Studies had to provide health literacy data for adult women and men with a migration background, collected with a standardised instrument, or report results that demonstrated the collection of such data. Health literacy data were extracted from eligible studies or requested from the respective authors. Using a random-effects model, a meta-analysis was conducted to assess standardised mean differences (SMDs) of health literacy in men and women. Two researchers independently assessed risk of bias for each included study using the Appraisal Tool for Cross-Sectional Studies. RESULTS: Twenty-four studies were included in this systematic review. Thereof, 22 studies (8012 female and 5380 male participants) were included in the meta-analyses. In six studies, gender-specific health literacy scores were reported. The authors of additional 15 studies provided their data upon request and for one further study data were available online. Women achieved higher health literacy scores than men: SMD=0.08, 95% CI 0.002 to 0.159, p=0.04, I2=65%. Another 27 studies reported data on female participants only and could not be included due to a lack of comparable studies with male participants only. Authors of 56 other eligible studies were asked for data, but without success. CONCLUSION: Men with a migration background-while being much less frequently examined-may have lower health literacy than women. As heterogeneity between studies was high and the difference became statistically insignificant when excluding studies with a high risk of bias, this result must be interpreted with caution. There is a paucity of research on the social and relational aspects of gender in relation to health literacy among people with a migration background, especially for men. PROSPERO REGISTRATION NUMBER: CRD42018085555.

Individual values and spirituality and their meaning for affective well-being and engagement with life in very old age.

BACKGROUND: Individuals' ideals and aspirations are considered to constitute a central reference frame for subjective evaluations of their perceived reality, and, thus, to be crucial for individual quality of life (QoL) outcomes. By examining individual values and spirituality in very old people, the aim of this study was to describe two constructs representing the aspirations of the individual, as well as the relation of these constructs to both hedonic and eudaimonic QoL outcomes in very old age (VOA). MATERIAL AND METHODS: Cross-sectional data from a representative survey of people in VOA (NRW80+, n = 1863) were used. Individual values were assessed based on the Portrait Value Questionnaire. A revised questionnaire was developed drawing on the Spiritual Health and Life-Orientation Measure. Individual values and spirituality were studied using descriptive statistics, and hierarchical linear regression models were used to analyze their predictive value for two QoL outcomes: 1) affective well-being as an indicator of hedonic QoL, which was assessed using the positive affect subscale of the short form of the Positive and Negative Affect Schedule, and 2) engagement with life, which captures eudaimonic aspects and which was measured with a subscale of the Valuation of Life Scale. RESULTS: The most important values were both protection and growth-oriented values with a social focus. However, only values representing strivings for growth had a positive association with QoL outcomes. Spirituality was of high relevance to very old people, although not in the sense of religious institutions or practices. Rather, it predominantly consisted in environmental, interpersonal, and transcendental connectedness, all of which were positively connected to QoL outcomes. CONCLUSION: Individual values and spirituality can be an important resource for hedonic as well as eudaimonic QoL; however, age-related losses may lead to an emphasis of protective values that are not beneficial in terms of QoL. To support older people on their spiritual journey, a broad concept of spirituality needs to be established among researchers as well as practitioners.

Stereotypes about very old people and perceived societal appreciation in very old age.

BACKGROUND: People in very old age (VOA) are expected to be confronted with particularly negative stereotypes. These influence societally shared behavior towards and judgements about them. Such external evaluations of individuals' lives are considered a crucial part of their quality of life (QoL). OBJECTIVE: The present study elaborated a) the societal appreciation perceived by people in VOA and b) the stereotypes about people in VOA held by stakeholders from key societal areas. The aim was to discuss possible connections between these external standards and individual life results. MATERIAL AND METHODS: A parallel mixed methods design was employed. Cross-sectional data from a representative survey of people aged 80 years and older (n = 1863) were analyzed by means of χ2-tests and Kruskal-Wallis tests to examine differences in perceived societal appreciation (PSA) by characteristics of the person, their biography, and current lifestyle. Linear regression models were used to investigate the impact of these characteristics on PSA. Regarding stereotypes about people in VOA, semi-structured interviews with stakeholders from key societal areas (n = 22) were analyzed using qualitative content analysis. The quantitative and qualitative findings were juxtaposed for comparison. RESULTS: PSA was predicted by health-related variables and productive activities. Several societal stakeholders highlighted that age-related losses pose challenges on very old individuals, their families, and society, whereas remaining potentials in VOA can and should be used for the benefit of others; however, stakeholders' perceptions differed by the extent of their professional contact with (very) old people. Different pathways were proposed through which the observed stereotypes and determinants of PSA might be connected (e.g., stereotype internalization). CONCLUSION: Our study illustrates the relevance of external standards for individual QoL and highlights the need for a normative perspective in the discussion about QoL and its enhancement.

[The flourishing life : Society, politics and the practice of old age]. / Das gute Leben : Gesellschaft, Politik und die Praxis des hohen Alters.

In the final article the authors focus on the concept of "flourishing life". The core results of the preceding articles are summarized and placed in this concept in the context of a critical discussion. Against the background, recommendations are formulated for the political and societal shaping of framework conditions, which are conducive for and promote a good life in very old age.

The NRW80+ study: conceptual background and study groups.

BACKGROUND: The study "Quality of life and well-being of the very old in North Rhine-Westphalia NRW80+" aims at giving a representative picture of the quality of life (QoL) in this population. Conceptually, QoL research has rarely considered the values of older individuals themselves and societal values, and their relevance for successful life conduct. Empirically, comparisons of different age groups over the age of 80 years are rare and hampered by quickly decreasing numbers of individuals in oldest age groups in the population of very old individuals. STUDY DESIGN AND THEORETICAL FRAMEWORK: This paper describes the population of the NRW80+ study and different age groups of very old individuals with respect to biographical background. Furthermore, using the challenges and potentials model of QoL in very old age (CHAPO), key aspects of QoL in late life are discussed and the importance of normative stipulations of what constitutes a successful life conduct are highlighted. In the NRW80+ study older age groups (i.e., 85-89 years, 90+ years) were deliberately overrepresented in the survey sample to enable robust cross-group comparison. Individuals willing to participate in the study but unable to participate in the interview themselves for health reasons were included by means of proxy interviews. The total sample included 1863 individuals and 176 individuals were represented by proxy interviews. Pronounced differences were observed between age groups 80-84 years (born 1933-1937, N = 1012), 85-89 years (born 1928-1932, N = 573), and 90 years or older (*born before 1927, N = 278) with respect to education, employment and the timing of major life events (e.g., childbirth). CONCLUSION: Different life courses and resulting living conditions should be considered when discussing QoL disparities in very old age.

"The system has to be health literate, too" - perspectives among healthcare professionals on health literacy in transcultural treatment settings.

BACKGROUND: Effective communication is a central aspect of organizational health literacy. Healthcare professionals are expected to ensure an effective and satisfactory flow of information and to support their patients in accessing, understanding, appraising, and applying health information. This qualitative study aimed to examine the health literacy-related challenges, needs, and applied solutions of healthcare professionals when engaging with persons with a migrant background. Based on the integrated model of health literacy (Sørensen et al., BMC Public Health 12:80, 2012), we focused on environmental, personal, and situational factors that shape health literacy in transcultural treatment settings. METHODS: We conducted five focus group discussions with healthcare professionals (N = 31) who are in regular contact with persons with a migrant background. Discussions were transcribed verbatim and analyzed using qualitative content analysis by applying a deductive-inductive categorization procedure. Deductive categories were derived from the integrated model of health literacy. RESULTS: Challenges included a mismatch in the provision and use of health services. Participants regarded easily accessible services and outreach counselling as helpful solutions. Further challenges were the migrant patients' distrust in healthcare professionals and the German healthcare system, the participants' uncertainty in dealing with patients' expectations and needs, and the patients' non-compliance with appointments. Environmental factors included systemic lack of time and economic pressure. Both were reported as impeding the flow of information in all treatment settings. Participants with a migrant background themselves (n = 16) regarded this personal factor as an opportunity that increased patients' trust in them. They also reported challenges such as high levels of responsibility felt when ad hoc interpreting for colleagues. CONCLUSIONS: Known issues observed in the delivery of healthcare for the majority population (i.e., systemic lack of time, economic pressure) appear to be intensified in the context of migration. An increasingly diverse patient clientele indicates a growing need for culture-sensitive, health-literate healthcare organizations. A corresponding diversity of the health workforce is desirable and should be strengthened by national finance and educational programs. Healthcare professionals who interpret for colleagues should be given the necessary time. Further studies are needed to develop appropriate interventions for improving health literacy at individual and organizational levels. Funding for interpreting services should be expanded.

The effects of webcams on German neonatal intensive care units - study protocol of a randomised crossover trial (Neo-CamCare).

BACKGROUND: The separation of parents and their prematurely born children during care in a neonatal intensive care unit (NICU) can have far-reaching consequences for the well-being of the parents and also of the children. The aim of this study is to evaluate the use of webcams on NICUs and to conduct a systematic assessment of their possible effects on parents and clinical staff. In addition, it aims at determining the need for webcams  in German NICUs and to identify possible barriers and moderators. The development and evaluation of practical guidance for the use of webcams will enable the comprehensive education of clinical staff and parents and, as a result, is intended to mitigate any potential undesirable consequences. METHODS: The study will be based on a mixed methods approach including all groups concerned in the care. Qualitative data will be collected in interviews and focus groups and evaluated using content analysis. The collection of quantitative data will be based on written questionnaires and will aim to assess the status quo as regards the use of webcams on German NICUs and the effects on parents, physicians, and nursing staff. These effects will be assessed in a randomised cross-over design. Four NICUs will be involved in the study and, in total, the parents of 730 premature babies will be invited to take part in the study. The effects on the nursing staff, such as additional workload and interruptions in workflows, will be evaluated on the basis of observation data. DISCUSSION: This study will be the largest multicentre study known to us that systematically evaluates the use of webcams in neonatal intensive care units. The effects of the  implementation of webcams on both parents and care providers will be considered. The results provide evidence to decide whether to promote the use of webcams on NICUs or not and what to consider when implementing them. TRIAL REGISTRATION: The trial has been registered at the German Clinical Trial Register (DRKS). Number of registration: DRKS00017755 , date of registration: 25.09.2019.

Biomarker-Based Risk Prediction of Alzheimer's Disease Dementia in Mild Cognitive Impairment: Psychosocial, Ethical, and Legal Aspects.

BACKGROUND: Today, a growing number of individuals with mild cognitive impairment (MCI) wish to assess their risk of developing Alzheimer's disease (AD) dementia. The expectations as well as the effects on quality of life (QoL) in MCI patients and their close others through biomarker-based dementia risk estimation are not well studied. OBJECTIVE: The PreDADQoL project aims at providing empirical data on effects of such prediction on QoL and at developing an ethical and legal framework of biomarker-based dementia risk estimation in MCI. METHODS: In the empirical study, 100 MCI-patients and their close others will be recruited from two sites (Germany and Spain). They receive standardized counselling on cerebrospinal fluid (CSF) biomarker-based prediction of AD dementia and a risk disclosure based on their AD biomarker status. A mixed methods approach will be applied to assess outcomes. RESULTS: The pilot-study yielded a specification of the research topics and newly developed questionnaires for the main assessment. Within this binational quantitative and qualitative study, data on attitudes and expectations toward AD risk prediction, QoL, risk communication, coping strategies, mental health, lifestyle changes, and healthcare resource utilization will be obtained. Together with the normative part of the project, an empirically informed ethical and legal framework for biomarker-based dementia risk estimation will be developed. CONCLUSION: The empirical research of the PreDADQoL study together with the ethical and legal considerations and implications will help to improve the process of counselling and risk disclosure and thereby positively affect QoL and health of MCI-patients and their close others in the context of biomarker-based dementia risk estimation.