[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.

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.

"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.

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.

[Digital data for more efficient prevention: ethical and legal considerations regarding potentials and risks]. / Digitale Daten für eine effizientere Prävention: Ethische und rechtliche Überlegungen zu Potenzialen und Risiken.

Digitization offers considerable potential for strengthening prevention in the healthcare system. Data from various clinical and nonclinical sources can be collected in a structured way and systematically processed using algorithms. Prevention needs can thus be identified more quickly and precisely, and interventions can be planned, implemented, and evaluated for specific target groups. At the same time, however, it is necessary that data processing not only meets high technical but also ethical standards and legal data protection regulations in order to avoid or minimize risks.This discussion article examines the potentials and risks of digital prevention first from a "data perspective," which deals with the use of health-related data for the purpose of prevention, and second from an "algorithm perspective," which focuses on the use of algorithmic systems, including artificial intelligence, for the assessment of needs and evaluation of preventive measures, from an ethical and legal point of view. Finally, recommendations are formulated for framework conditions that should be created to strengthen the further development of prevention in the healthcare system.

[Spirituality in old age as dynamic aging task]. / Spiritualität im höheren Lebensalter als dynamische Alter(n)saufgabe.

BACKGROUND: A multitude of studies have demonstrated a positive effect of spirituality for dealing with difficult situations in life; however, specific studies on spirituality in older age are exceptionally rare within the German gerontological research landscape. The theory of gerotranscendence by Tornstam indicates that spirituality is of particular importance for maintaining life satisfaction especially in older age, due to a change in perspective. OBJECTIVES: This study looked into the research questions of how spirituality is presented in the oldest old (80 years and older) in Germany and to what extent its characteristics are specific to older age. MATERIAL AND METHODS: Problem-centered interviews were conducted with 20 oldest old subjects and evaluated using qualitative content analysis. RESULTS: Spirituality in itself is not specific to very old age. Its shaping, however, as an existential process of transformation and redefinition, is specific in the oldest old due to their socialization and biographical experiences over the life course impregnated by processes of subjectification and individualization. In addition, its relation to existential questions gains increasing relevance and priority in very old age in an affective, reflective and performative dimension, and the answers change between fragility and continuity. CONCLUSION: As a heterogeneous (intermediate) result of experiences over the life course against the background of socialization and individual existential interpretation of "Self" and "World", spirituality in the oldest old should be perceived in this diverse and dynamic manner in research and practice, in order to foster well-being in old age.

[Wearables to support self-management of older adults with chronic diseases : A qualitative study from the perspectives of patients and physicians]. / Wearables zur Unterstützung des Selbstmanagements von älteren Menschen mit chronischen Erkrankungen : Eine qualitative Studie aus der Perspektive von Patienten und Ärzten.

BACKGROUND: The use of wearable devices (WD) is discussed as an option to support elderly chronically ill people. These technologies lack essential research regarding the improvement of self-management. This study aimes to identify perspectives, expectations and their underlying background of patients and physicians with respect to the usage of WDs to enhance self-management. METHODS: In this study a total of 14 patients and physicians were surveyed using a semi-structured questionnaire design. The data were analyzed by qualitative content analysis. RESULTS: The participants have in general a positive attitude towards the use of WDs with respect to memory function, self-control, sense of security, documentation of vital parameters and communication about the disease, as well as suitability for everyday use; however, in many cases participants are concerned about the usage of WDs for a variety of reasons. They perceive the device as unnecessary or they lack technological self-confidence and felt controlled as well as data protection concerns. Participant responses show prerequisites which should be met for the usage of a WD requiring an individual needs assessment. CONCLUSION: The results show a potential of WDs to improve self-management. The usage of WD could have a positive effect on the course of the disease; however, personality and environmental factors should be taken into account to individually adjust and support the usage of WDs. Furthermore, the application of WDs should be integrated into a structured training program accompanied by healthcare professionals. For this purpose, funding and time-oriented framework conditions should be established.

Quality of life of the very old : Survey on quality of life and subjective well-being of the very old in North Rhine-Westphalia (NRW80+).

BACKGROUND: In Germany, the very old are the most rapidly growing proportion of the population. A comprehensive investigation of the conditions for a good quality of life in this group is relevant for both society and politics. OBJECTIVE: The project "Quality of life and subjective well-being of the very old in North Rhine-Westphalia" (NRW80+) at the University of Cologne surveys quality of life of the very old. Taking into account many specific methodological and theoretical challenges, it aims at setting up a specific theoretical framework and methodological approach. METHODS: Existing studies on quality of life in old age in Germany and abroad as well as models on quality of life are reviewed with respect to their relevance for the very old and their specific living conditions, needs and interests. A theoretical framework of quality of life in very old age is developed. The NRW80+ study combines three levels: the empirical level of description of life situations and conditions, the explanative level of evaluating models of quality of life and the normative level of societal and ethical standards and norms. RESULTS: Considering results of recently conducted studies with the very old, an integrative conceptual model for studying quality of life of very old persons is introduced. In the model of challenges and potentials (CHAPO), environmental and individual factors as well as life chances and life results are thereby taken into consideration from a subjective as well as an objective point of view, supplemented by the concept of successful life conduct. CONCLUSION: Starting from the CHAPO model of quality of life, the representative study NRW80+ aims at challenging methodological standards for the inclusion of the very old in social research thus providing the basis for further research as well as for sustainable social politics especially for the very old.

Caregiver burden and the medical ethos.

Are physicians sometimes morally required to ease caregiver burden? In our paper we defend an affirmative answer to this question. First, we examine the well-established principle that medical care should be centered on the patient. We argue that although this principle seems to give physicians some leeway to lessen caregivers' suffering, it is very restrictive when spelled out precisely. Based on a critical analysis of existing cases for transcending patient-centeredness we then go on to argue that the medical ethos should indeed contain a rule requiring physicians to alleviate caregiver burden under certain circumstances. Finally, we apply our findings to deep brain stimulation (DBS) for Parkinson's disease. We present empirical data from a recent study of DBS indicating that spousal caregivers of Parkinson patients treated with DBS are sometimes deeply troubled by the effects of the therapy and discuss what moral obligations the treating physicians may have in such cases.

The role of nursing team continuity in the treatment of very-low-birth-weight infants: findings from a pilot study.

AIM: To assess the association between nursing team continuity and quality of care. BACKGROUND: Research on nurse staffing and its effect on quality of care is investigated to different degrees. However, very few studies have observed whether the continuous deployment of nursing staff is associated with quality of care. METHODS: This study was conducted in two university neonatal intensive care units (NICUs). We matched nurse schedule data for the NICUs with nursing-sensitive patient outcomes and quality of care, as perceived by parents. We used analysis of variance to analyse differences in nursing team continuity between NICUs and regression analyses to identify associations with the outcome measures. RESULTS: There were considerable differences between units in terms of team continuity of nursing staff. Positive associations were found between team continuity and a higher rate of non-invasive respiratory support as well as parents' perceptions of how well they knew their nurse. CONCLUSIONS: The findings show remarkable differences in staff assignment in the different NICUs. In addition to appropriate staffing levels, scheduling nursing teams continuously would appear to play a role in influencing treatment quality. IMPLICATIONS FOR NURSING MANAGEMENT: This paper emphasises the importance of carefully considered staff scheduling decisions.

Staff and parents are discriminators for outcomes in neonatal intensive care units.

AIM: We investigated the associations between staff work characteristics, parents' experiences and a number of medical outcome measures. METHODS: This explorative multicentre study took place in the neonatal intensive care units (NICUs) of five German university hospitals between 2009 and 2011. We assessed staff work characteristics by surveying 126 NICU nurses and 57 physicians and asked 214 parents about their relationships with staff. The outcome variables of 230 premature infants with birth weights of less than 1500 g were collected over a period of 18 months. We used analysis of variance (ANOVA) and regression analyses for statistical purposes. RESULTS: We found differences in outcome measures between the NICUs, particularly parameters of respiratory support, weight gain and length of stay. When we controlled for the NICUs' baseline factors, perceptions of the relationship between staff and parents (empathy, p < 0.001; conversation duration and frequency, p < 0.05; familiarity, p < 0.05) and staff work characteristics (workload, p < 0.05) were associated with at least one of these outcome measures. CONCLUSION: Staff and parents were discriminators for neonatal outcomes through perceptions of work characteristics and the relationship between staff and parents, respectively. Respiratory support and nutrition measures were particularly sensitive. This research has prompted a nationwide, multicentre study of 66 NICUs.

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.

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.

Patients' expectations of deep brain stimulation, and subjective perceived outcome related to clinical measures in Parkinson's disease: a mixed-method approach.

OBJECTIVE: To study patients' expectations of subthalamic deep brain stimulation (STN-DBS) and their subjective perceived outcome, by using qualitative and quantitative methods in Parkinson's disease (PD). METHODS: PD patients were prospectively examined before and 3 months after surgery. Semistructured interviews regarding preoperative expectations and postsurgical subjective perceived outcome were conducted. These were analysed using content analysis. For statistical analyses, patients were classified according to their subjective perceived outcome, resulting in three different subjective outcome groups (negative, mixed, positive outcome). The groups were used for multiple comparisons between and within each group regarding motor impairment, quality of life (QoL), neuropsychiatric status and cognitive functioning, using standard instruments. A logistic regression analysis was conducted to find predictors of subjective negative outcome. Receiver operating characteristic curves were used to analyse cut-off scores for predictive tests. RESULTS: Of the 30 PD patients participating, 8 had a subjective negative outcome, 8 a mixed and 14 a positive outcome. All groups significantly improved in motor functioning. Patients with subjective negative outcome were characterised by preoperative unrealistic expectations, no postsurgical improvement in QoL, and significantly higher presurgical and postsurgical apathy and depression scores. Higher preoperative apathy and depression scores were significant predictors of negative subjective outcome. Cut-off scores for apathy and depression were identified. CONCLUSIONS: The mixed-method approach proved useful in examining a patient's subjective perception of STN-DBS outcome. Our results show that significant motor improvement does not necessarily lead to a positive subjective outcome. Moreover, PD patients should be screened carefully before surgery regarding apathy and depression. (DRKS-ID: DRKS00003221).