Factors Influencing Health-Related Quality of Life of Patients with Spinocerebellar Ataxia.

BACKGROUND: Little is known about the progression of health-related quality of life (HRQoL) and predicting factors in spinocerebellar ataxia (SCA). Such knowledge is crucial to identify modifiable factors promoting everyday life with SCA and attenuating HRQoL decline. OBJECTIVES: This study is to assess HRQoL progression and identify factors affecting SCA patients' HRQoL. METHODS: Longitudinal data (three-year follow-up) of 310 SCA patients of the European SCA3/Machado-Joseph-Disease Initiative (ESMI) (2016-2022) and 525 SCA patients (SCA1, SCA2, SCA3 or SCA6) of the EUROSCA natural history study cohort (2006-2015) were assessed. Both large cohort studies share standardized assessments of clinical measures, SARA, INAS, PHQ-9, and HRQoL (EQ-5D-3L). The association between HRQoL and clinical measures was assessed by Spearman Correlation (rs). Multivariable panel regression models were performed to evaluate the impact of patients' socio-demographics, age of onset, SCA type and body mass index (BMI), and clinical measures on HRQoL progression. RESULTS: HRQoL significantly decreased over one (- 0.014, p = 0.095), two (- 0.028, p = 0.003), and three years (- 0.032, p = 0.002). Ataxia severity and mental health strongly correlated with HRQoL (rsSARA = - 0.589; rsPHQ-9 = - 0.507). HRQoL more intensively declined in male (ß = - 0.024, p = 0.038) patients with an earlier age of onset (ß = 0.002, p = 0.058). Higher progression of ataxia severity (ß = - 0.010, p ≤ 0.001), mental health problems (ß = - 0.012, p < 0.001), and higher BMI (ß = - 0.003, p = 0.029) caused more severe decline of patients' HRQoL over time. DISCUSSION: In absence of curative treatments, stronger focus on mental health and weight influence could help clinical evaluation and accompany treatment improving SCA patients' HRQoL, especially in male patients with early disease onset.

Health Fluctuations in Dementia and its Impact on the Assessment of Health-Related Quality of Life Using the EQ-5D-5L.

OBJECTIVES: To quantify health fluctuations, identify affected health-related quality of life (HRQoL) dimensions, and evaluate if fluctuations affect the HRQoL instruments recall period adherence in people living with dementia (PlwD). METHODS: Caregivers of PlwD completed a daily diary for 14 days, documenting if PlwD's health was better or worse than the day before and the affected HRQoL dimensions. Health fluctuation was categorized into low (0-4 fluctuations in 14 days), moderate (5-8), and high (9-14). Also, caregivers and PlwD completed the EQ-5D-5L (proxy- and self-reported) on days 1, 7, and 14. Subsequently, caregivers were interviewed to determine whether recurrent fluctuations were considered in the EQ-5D-5L assessment of today's health (recall period adherence). RESULTS: Fluctuations were reported for 96% of PlwD, on average, for 7 of the 14 days. Dimensions most frequently triggering fluctuations included memory, mobility, concentration, sleep, pain, and usual activities. Fluctuations were associated with higher EQ-5D-5L health-states variation and nonadherence to the EQ-5D-5L recall period "today." PlwD with moderate to high fluctuation had the highest EQ-5D-5L utility change between day 1 and 14 (0.157 and 0.134) and recall period nonadherence (31% and 26%) compared with PlwD with low fluctuation (0.010; 17%). Recall period nonadherence was higher in PlwD with improved compared with those with deteriorated health in the diary (37% vs 9%). CONCLUSIONS: Health fluctuations frequently occur in dementia and strongly affect HRQoL assessments. Further research is needed to evaluate if more extended recall periods and multiple, consecutive assessments could capture health fluctuations more appropriately in dementia.

Health-Related Quality of Life in Patients with Spinocerebellar Ataxia: a Validation Study of the EQ-5D-3L.

Although health-related quality of life (HRQoL) has developed into a crucial outcome parameter in clinical research, evidence of the EQ-5D-3L validation performance is lacking in patients with spinocerebellar ataxia (SCA) types 1, 2, 3, and 6. The objective of this study is to assess the acceptability, validity, reliability, and responsiveness of the EQ-5D-3L. For n = 842 predominantly European SCA patients of two longitudinal cohort studies, the EQ-5D-3L, PHQ-9 (Patient Health Questionnaire), and ataxia-specific clinical assessments (SARA: Scale for Assessment and Rating of Ataxia; ADL: activities of daily living as part of Friedreich's Ataxia Rating Scale; INAS: Inventory of Non-Ataxia Signs) were assessed at baseline and multiple annual follow-ups. The EQ-5D-3L was evaluated regarding acceptability, distribution properties, convergent and known-groups validity, test-retest reliability, and effect size measures to analyze health changes. The non-item response was low (EQ-5D-3L index: 0.8%; EQ-VAS: 3.4%). Ceiling effects occurred in 9.9% (EQ-5D-3L) and 3.0% (EQ-VAS) with a mean EQ-5D-3L index of 0.65 ± 0.21. In total, convergent validity showed moderate to strong Spearman's rho (rs > 0.3) coefficients comparing EQ-5D-3L and EQ-VAS with PHQ-9, SARA, ADL, and INAS. EQ-5D-3L could discriminate between groups of age, SARA, ADL, and INAS. Intra-class correlation coefficients (EQ-5D-3LICC: 0.95/EQ-VASICC: 0.88) and Kappa statistics (range 0.44 to 0.93 for EQ-5D-3L items) indicated tolerable reliability. EQ-5D-3L shows small (effect size < 0.3) to moderate (effect size 0.3-0.59) health changes regarding ataxia severity. The analysis confirms an acceptable, reliable, valid, and responsive recommended EQ-5D-3L in SCA patients, measuring the HRQoL adequately, besides well-established clinical instruments.

Impact of low-value medications on quality of life, hospitalization and costs - A longitudinal analysis of patients living with dementia.

INTRODUCTION: This study aimed to analyze the impact of low-value medications (Lvm), that is, medications unlikely to benefit patients but to cause harm, on patient-centered outcomes over 24 months. METHODS: This longitudinal analysis was based on baseline, 12 and 24 months follow-up data of 352 patients with dementia. The impact of Lvm on health-related quality of life (HRQoL), hospitalizations, and health care costs were assessed using multiple panel-specific regression models. RESULTS: Over 24 months, 182 patients (52%) received Lvm at least once and 56 (16%) continuously. Lvm significantly increased the risk of hospitalization by 49% (odds ratio, confidence interval [CI] 95% 1.06-2.09; p = 0.022), increased health care costs by €6810 (CI 95% -707€-14,27€; p = 0.076), and reduced patients' HRQoL (b = -1.55; CI 95% -2.76 to -0.35; p = 0.011). DISCUSSION: More than every second patient received Lvm, negatively impacting patient-reported HRQoL, hospitalizations, and costs. Innovative approaches are needed to encourage prescribers to avoid and replace Lvm in dementia care. HIGHLIGHTS: Over 24 months, more than every second patient received low-value medications (Lvm). Lvm negatively impact physical, psychological, and financial outcomes. Appropriate measures are needed to change prescription behaviors.

What difference does multiple imputation make in longitudinal modeling of EQ-5D-5L data? Empirical analyses of simulated and observed missing data patterns.

PURPOSE: Although multiple imputation is the state-of-the-art method for managing missing data, mixed models without multiple imputation may be equally valid for longitudinal data. Additionally, it is not clear whether missing values in multi-item instruments should be imputed at item or score-level. We therefore explored the differences in analyzing the scores of a health-related quality of life questionnaire (EQ-5D-5L) using four approaches in two empirical datasets. METHODS: We used simulated (GR dataset) and observed missingness patterns (ABCD dataset) in EQ-5D-5L scores to investigate the following approaches: approach-1) mixed models using respondents with complete cases, approach-2) mixed models using all available data, approach-3) mixed models after multiple imputation of the EQ-5D-5L scores, and approach-4) mixed models after multiple imputation of EQ-5D 5L items. RESULTS: Approach-1 yielded the highest estimates of all approaches (ABCD, GR), increasingly overestimating the EQ-5D-5L score with higher percentages of missing data (GR). Approach-4 produced the lowest scores at follow-up evaluations (ABCD, GR). Standard errors (0.006-0.008) and mean squared errors (0.032-0.035) increased with increasing percentages of simulated missing GR data. Approaches 2 and 3 showed similar results (both datasets). CONCLUSION: Complete cases analyses overestimated the scores and mixed models after multiple imputation by items yielded the lowest scores. As there was no loss of accuracy, mixed models without multiple imputation, when baseline covariates are complete, might be the most parsimonious choice to deal with missing data. However, multiple imputation may be needed when baseline covariates are missing and/or more than two timepoints are considered.

[Transfer of Physicians' Tasks to Nurses in the Care of People with Dementia]. / Aufgabenübertragung ärztlicher Tätigkeiten in der Versorgung von Menschen mit Demenz auf Pflegefachpersonen in Substitution und Delegation.

THE AIM OF THE STUDY: A transfer of medical activities to nurses and thus the redistribution of tasks has been discussed for almost 15 years. A legal base for model projects has been enacted. However, clearly defined tasks for substitution are still lacking. The aim of this study was to solicit opinions of general practitioners, nurses, people with dementia (PwD) and their relatives about the possibility of a large number of specific General practitioner (GP) tasks being performed by nurses in outpatient dementia care. METHODS: A mixed-methods study with a sequential in-depth design was conducted. The analysis presented here refers to the quantitative survey of the four participant groups. 865 participants were asked about the acceptance of substitution of assessments, primary and follow-up prescriptions, health monitoring measures and other activities currently performed by physicians. RESULTS: Across all groups of subjects, the highest level of approval for substitution was achieved for the assessment of mobility restrictions, everyday competencies, nutritional abnormalities, prescription of transportation, nursing aids, home nursing services and drawing of blood samples. Among PwD and relatives, the level of acceptance for substitution was very high. 88% of the PwD and relatives indicated that many activities can be substituted while the general practitioner remained their first point of contact. More GPs (63.2%) than nurses (56.7%) would accept the substitution. CONCLUSION: The results indicate that a large number of GPs, nurses, patients and their relatives welcome substitution. However, PwD and relatives have a significantly more positive attitude towards substitution.

Translation and adaptation of the German version of the Veterans Rand-36/12 Item Health Survey.

BACKGROUND: The translated and culturally adapted German version of the Veterans Rand 36 Items Health Survey (VR-36), and its short form, the VR-12 counterpart, were validated in a German sample of orthopedic (n = 399) and psychosomatic (n = 292) inpatient rehabilitation patients. METHODS: The instruments were analyzed regarding their acceptance, distributional properties, validity, responsiveness and ability to discriminate between groups by age, sex and clinically specific groups. Eligible study participants completed the VR-36 (n = 169) and the VR-12 (n = 177). They also completed validated patient-reported outcome measures (PROs) including the Euroqol-5 Dimensions 5 Level (EQ-5D-5L); Depression, Anxiety and Stress Scale (DASS); Hannover Functional Abilities Questionnaire (HFAQ); and CDC Healthy Days. The VR-12 and the VR-36 were compared to the reference instruments MOS Short Form-12 Items Health Survey (SF-12) version 1.0 and MOS Short Form-36 Items Health Survey (SF-36) version 1.0, using percent of completed items, distributional properties, correlation patterns, distribution measures of known groups validity, and effect size measures. RESULTS: Item non-response varied between 1.8%/1.1% (SFVR-36/RESF-36) and 6.5%/8.6% (GHVR-36/GHSF-36). PCS was normally distributed (Kolmogorov-Smirnov tests: p > 0.05) with means, standard deviations and ranges very similar between SF-36 (37.5 ± 11.7 [13.8-66.1]) and VR-36 (38.5 ± 10.1 [11.7-67.8]), SF-12 (36.9 ± 10.9 [15.5-61.6]) and VR-12 (36.2 ± 11.5 [12.7-59.3]). MCS was not normally distributed with slightly differing means and ranges between the instruments (MCSVR-36: 36.2 ± 14.2 [12.9-66.6], MCSSF-36: 39.0 ± 15.6 [2.0-73.2], MCSVR-12: 37.2 ± 13.8 [8.4-70.2], MCSSF-12: 39.0 ± 12.3 [17.6-65.4]). Construct validity was established by comparing correlation patterns of the MCSVR and PCSVR with measures of physical and mental health. For both PCSVR and MCSVR there were moderate (≥ 0.3) to high (≥ 0.5) correlations with convergent (PCSVR: 0.55-0.76, MCSVR: 0.60-0.78) and small correlations (< 0.1) with divergent (PCSVR: < 0.12, MCSVR: < 0.16) self-report measures. Known-groups validity was demonstrated for both VR-12 and VR-36 (MCS and PCS) via comparisons of distribution parameters with significant higher mean PCS and MCS scores in both VR instruments found in younger patients with fewer sick days in the last year and a shorter duration of rehabilitation. CONCLUSIONS: The psychometric analysis confirmed that the German VR is a valid and reliable instrument for use in orthopedic and psychosomatic rehabilitation. Yet further research is needed to evaluate its usefulness in other populations.

Attitudes towards advanced nursing roles in primary dementia care - Results of an observational study in Germany.

AIMS: To demonstrate the attitudes of general practitioners (GPs), nurses, persons with dementia, and caregiver towards suitable tasks and qualification needs for and the acceptance and impact of advanced nursing roles in German dementia primary care. DESIGN: Observational study using a questionnaire survey with 225 GPs, 232 nurses, 211 persons with dementia, and 197 caregivers, conducted between December 2017-August 2018. METHODS: A questionnaire was generated that includes specific assessment, prescription, and monitoring tasks of advanced nursing roles in dementia primary care as well as qualification requirements for and the acceptance and the impact of advanced nursing roles. Data were analysed using descriptive statistics. Group differences were assessed using the Fisher's exact test. RESULTS: Advanced nursing roles were highly appreciated across all groups. Assessment and monitoring tasks were rated as highly suitable, and prescription authorities as moderately suitable. Nurses felt less confident in assessment and monitoring, but more confident in prescribing as practitioners expected. Patients and caregivers would appreciate a takeover of tasks by nurses; nurses and practitioners preferred a delegation. A dementia-specific qualification was rated as best suitable for advanced nursing roles, followed by 'no specific qualification' if medical tasks that only can be carried out by practitioners were delegated and an academic degree if tasks were substituted. Advanced nursing roles were rated as beneficial, strengthening the confidence in nursing care and improving the cooperation between professionals and the treatment. Practitioners assumed that advanced nursing roles would improve job satisfaction of nurses, which was not confirmed by nurses. CONCLUSION: There is an extended consensus towards the enlargement of advanced nursing roles, represented by high endorsement, acceptance, and willingness to reorganize tasks. IMPACT: Results debunk the common notion that German practitioners would be reluctant towards advanced nursing roles and a takeover of current practitioner tasks, supporting the implementation of advanced nursing roles in Germany.

Concepts of health in long-term home care: An empirical-ethical exploration.

BACKGROUND: Concepts of health have been widely discussed in the philosophy and ethics of medicine. Parallel to these theoretical debates, numerous empirical research projects have focused on subjective concepts of health and shown their significance for individuals and society at various levels. Only a few studies have so far investigated the concepts of health of non-professionals and professionals involved in long-term home care and discussed these empirical perspectives regarding moral responsibilities. OBJECTIVES: To identify the subjective concepts of the health of non-professionals (care recipients, informal caregivers) and professionals (registered nurses) involved in long-term home care and to discuss them against the background of existing normative guidelines addressing non-professionals and professionals' responsibilities and rights concerning health. RESEARCH DESIGN: A qualitative design was chosen to explore subjective concepts of health. Data were collected by semi-structured interviews; content analysis was applied according to Mayring. PARTICIPANTS AND RESEARCH CONTEXT: Twenty-eight interviews were conducted with non-professionals and professionals in long-term home care arrangements in Northern Germany. ETHICAL CONSIDERATIONS: Ethics approval was obtained from the Institutional Review Board at the University Medicine Greifswald (BB123/16). FINDINGS: Non-professionals and professionals consider health as a capability that enables them to participate in social activities and live their own lives according to their preferences. The former regard health particularly as a feeling and an attitude, the latter as the absence of disease with a focus on mental and emotional well-being. Both groups highlight the unsurpassable value of health and the personal responsibility for it. DISCUSSION: Normative guidelines applicable to practice in long-term home care discuss responsibilities and rights unevenly and raise several problems regarding non-professionals and professionals' subjective concepts of health. CONCLUSION: Individuals' concepts of health are relevant for the subsequent interpretation of rights and responsibilities and should, thus, be reflected upon to address health-related needs effectively.

Relationships and burden: An empirical-ethical investigation of lived experience in home nursing arrangements.

Quantitative research has called attention to the burden associated with informal caregiving in home nursing arrangements. Less emphasis has been placed, however, on care recipients' subjective feelings of being a burden and on caregivers' willingness to carry the burden in home care. This article uses empirical material from semi-structured interviews conducted with older people affected by multiple chronic conditions and in need of long-term home care, and with informal and professional caregivers, as two groups of relevant others. The high burden of home-care arrangements is unanimously stressed by all three groups involved in the triangle of care. An empirical-ethical investigation of what can be legitimately expected from family members and informal caregivers, informed by Frith's symbiotic empirical ethics approach, was undertaken. Key tenets from the special goods theory and nursing professionalism are used as analytical tools. The study concludes that the current situation may hinder professional development and can reinforce feelings of being a burden to relevant others.

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.

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.

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.

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.

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.

Patient-reported, health economic and psychosocial outcomes in patients with Friedreich ataxia (PROFA): protocol of an observational study using momentary data assessments via mobile health app.

INTRODUCTION: Friedreich ataxia (FA) is the most common hereditary ataxia in Europe, characterised by progressively worsening movement and speech impairments with a typical onset before the age of 25 years. The symptoms affect the patients' health-related quality of life (HRQoL) and psychosocial health. FA leads to an increasing need for care, associated with an economic burden. Little is known about the impact of FA on daily lives and HRQoL. To fill that gap, we will assess patient-reported, psychosocial and economic outcomes using momentary data assessment via a mobile health application (app). METHODS AND ANALYSIS: The PROFA Study is a prospective observational study. Patients with FA (n=200) will be recruited at six European study centres (Germany, France and Austria). We will interview patients at baseline in the study centre and subsequently assess the patients' health at home via mobile health app. Patients will self-report ataxia severity, HRQoL, speech and hearing disabilities, coping strategies and well-being, health services usage, adverse health events and productivity losses due to informal care on a daily to monthly basis on the app for 6 months. Our study aims to (1) validate measurements of HRQoL and psychosocial health, (2) assess the usability of the mobile health app, and (3) use descriptive and multivariate statistics to analyse patient-reported and economic outcomes and the interaction effects between these outcomes. Insights into the app's usability could be used for future studies using momentary data assessments to measure outcomes of patients with FA. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Committee of the University Medicine of Greifswald, (BB096/22a, 26 October 2022) and from all local ethics committees of the participating study sites. Findings of the study will be published in peer-reviewed journals, presented at relevant international/national congresses and disseminated to German and French Patient Advocacy Organizations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05943002); Pre-results.

Associations of Depressive Symptoms with Subjective Cognitive Decline in Elderly People-A Cross-Sectional Analysis from the AgeWell.de-Study.

To develop effective dementia prevention strategies, it is necessary to understand risk factors, associated factors and early signs of dementia. Subjective cognitive decline (SCD) is the earliest form of dementia. The aim of this study is to assess depression as a factor that is significantly associated with SCD. The data of 1030 general practitioner patients from the AgeWell.de-study (60-77 years; CAIDE dementia risk score ≥ 9) were analysed. A descriptive analysis was conducted using validated instruments like the Geriatric depression scale (GDS), Lubben social network scale (LSNS-6) and education classes according to CASMIN (Comparative Analysis of Social Mobility in Industrial Nations). A multivariate regression model with the dependent variable SCD was calculated. Of the 1030 participants, 5.9% had depressive symptoms and 31.3% SCD. The group with depressive symptoms showed significantly higher body-mass-index (p = 0.005), lower education class (p = 0.022), lower LSNS-6 score (p < 0.001), higher sports activity (p < 0.001), and more sleeping problems (p = 0.026). In the regression model a higher GDS-score [Odds ratio (OR): 1.219 (p < 0.001)], more sleeping problems [OR: 1.550 (p = 0.017)] and higher education class [middle/high: OR: 1.474/1.875 (p = 0.037/0.004)] were significantly associated with SCD. This study identified depressive symptoms, sleeping problems, and higher education classes as factors associated with SCD, which can represent an early form of dementia.

Association between Alcohol Consumption and Health-Related Quality of Life among Hospital and Ambulatory Care Patients with Past Year Depressive Symptoms.

BACKGROUND: Little is known about how substance use affects health-related quality of life (HRQOL) in depressed individuals. Here, associations between alcohol consumption and HRQOL in hospital and ambulatory care patients with past-year depressive symptoms are analyzed. METHOD: The sample consisted of 590 participants (26.8% non-drinkers) recruited via consecutive screenings. Individuals with alcohol use disorders were excluded. HRQOL was assessed with the Veterans Rand 12-item health survey (VR-12). Multivariable fractional polynomials (MFP) regression analyses were conducted (1) to test for non-linear associations between average daily consumption and HRQOL and (2) to analyze associations between alcohol consumption and the physical and mental health component summaries of the VR-12 and their subdomains. RESULTS: Alcohol consumption was positively associated with the physical health component summary of the VR-12 (p = 0.001) and its subdomains general health (p = 0.006), physical functioning (p < 0.001), and bodily pain (p = 0.017), but not with the mental health component summary (p = 0.941) or any of its subdomains. Average daily alcohol consumption was not associated with HRQOL. CONCLUSION: Alcohol consumption was associated with better physical HRQOL. Findings do not justify ascribing alcohol positive effects on HRQOL. Data indicate that non-drinkers may suffer from serious health disorders. The results of this study can inform the development of future alcohol- and depression-related interventions.

[Qualification requirements for the re-delegation of medical activities to nursing professionals (with extended competencies)]. / Qualifikationsbedarf für Pflegefachpersonen (mit erweiterten Kompetenzen) bei einer Aufgabenneuverteilung ärztlicher Tätigkeiten.

BACKGROUND: For many years, the redistribution of tasks and thus a transfer of medical activities to nursing professionals with extended competencies has been discussed in Germany and is currently being regulated by the federal government. OBJECTIVES: The aim of this study was to record the opinions of GPs and nurses on the qualification requirements for possible delegable and substitutable medical activities to nurses using the example of outpatient dementia care. METHOD: In the context of a quantitative survey, the qualification requirements for the delegation of 30 different activities to nurses were collected from primary care physicians and nurses. A total of 1,634 questionnaires was distributed. The response rate was 28.0 % (primary care physicians: n=225, and nursing specialists: n=232). The analyses were carried out descriptively using SPSS software (version 25, IBM Corp., 2017). RESULTS: 45.1% of the respondents said they needed additional qualification prior to such a task transfer. This need primarily relates to further training (37.3%). Those seeking a university education (36.2%), will either pursue a Bachelor's (15.6%) or a Master's degree (20.6%) to obtain the necessary qualification. CONCLUSION: The results of this study can help define the activity profiles of academically qualified nursing professionals and inform the development of curricula for their university education. Furthermore, they will support the further development of the legal framework.

Social Network and Participation in Elderly Primary Care Patients in Germany and Associations with Depressive Symptoms-A Cross-Sectional Analysis from the AgeWell.de Study.

This study aims to describe social network and social participation and to assess associations with depressive symptoms in older persons with increased risk for dementia in Germany. We conducted a cross-sectional observational study in primary care patients (aged 60−77) as part of a multicenter cluster-randomized controlled trial (AgeWell.de). We present descriptive and multivariate analyses for social networks (Lubben Social Network Scale and subscales) and social participation (item list of social activities) and analyze associations of these variables with depressive symptoms (Geriatric Depression Scale). Of 1030 included patients, 17.2% were at risk for social isolation (Lubben Social Network Scale < 12). Looking at the subscales, a reduced non-family network was found almost twice as often as a reduced family network. Patients with depressive symptoms had significantly smaller social networks than patients without depression (p < 0.001). They rather engaged in social activities of low involvement level or no weekly social activity at all (p < 0.001). The study shows associations of depressive symptoms with a decreased social network and less social participation in elderly participants. Sufficient non-family contacts and weekly social activities seem to play an important role in mental health and should be encouraged in elderly primary care patients.