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Simple Summary: High-dose therapy with melphalan followed by autologous stem cell transplantation and lenalidomide maintenance has long been the standard of care for newly diagnosed patients with multiple myeloma. However, it is unclear how lenalidomide dosage or experienced side effects govern patients' quality of life during long-term treatment. The LenaMain trial (NCT00891384) investigated lenalidomide maintenance at a high (25 mg) and a low dose (5 mg) and demonstrated that dosage had no impact on patients' quality of life. Instead, high baseline scores for global health were maintained throughout the trial without difference between treatment arms which supports the feasibility of continuous lenalidomide treatment with a dose tailored to patients' quality of life. Introduction: The LenaMain trial (NCT00891384) reported increased progression-free survival with 25 mg of lenalidomide maintenance compared to 5 mg. Here, we report the patient-reported outcomes. Materials and Methods: Scores obtained from the EORTC Quality of Life Questionnaire C30 were analyzed for longitudinal changes from baseline within the groups as well as cross-sectional scores. Results: Compliance rates were high, with 95.7% at baseline and 70% during maintenance. At study entry, scores were high for functioning and low for symptoms. During maintenance, the median global health status/quality of life (GHS/QoL) was constant, without significant differences over time (median GHS/QoL: 68 at baseline and 58 for Len high and 68 for Len low at 2 years) and between treatment arms (mean change < 2). Similarly, most functional scale domains were constant. Notably, diarrhea increased consistently for both treatment arms (baseline: −1.905 (range: −5.78–1.97); end of year 2: 16.071 (range: 5.72–26.42); p < 0.05). The subgroup analysis showed that neither disease activity, duration of treatment, nor adverse events affected the health-related quality of life (HR-QoL) or utility. Conclusion: High baseline scores were maintained throughout the trial without significant differences between the Len dosages, which supports continuous treatment with a dose tailored to patients' HR-QoL. [ABSTRACT FROM AUTHOR]

Recognizing the ageing of populations and expected increase in prevalence of dementia, the necessity of research involving persons with dementia is widely agreed upon. Autonomy is key to nursing home residents' well-being and quality of life, but this phenomenon has not been thoroughly assessed from the residents' perspective. The aim of this cross-sectional study was to investigate perceived autonomy of nursing home residents. Data on 560 randomly selected residents in 40 nursing homes in two German federal states were generated by face-to-face interviews, psychological and physical assessments, analysis of nursing records, and acquisition of institutional parameters. This paper reports on a subsample ( n = 179) that met screening requirements, including subjects with and without mild cognitive impairment ( Mini Mental Status Examination score 30-18), who completed the Hertz Perceived Enactment of Autonomy Scale ( HPEAS). The mean score of HPEAS was 101.1 ± 14.5 (range 54-122). In our population, Cronbach's alpha was 0.89. Scores in HPEAS were not related to demographical factors but positively associated with increasing self-efficacy and absence of pain. The novel findings contribute to an understanding of autonomy from the residents' perspective. [ABSTRACT FROM AUTHOR]

Objectives: The aim of the present paper was, first, to analyze a four level biopsychosocial model to examine the interaction of various initial health behaviors and, second, their consequences with respect to the course of physical fitness (PF) and health of adults over the course of 18 years. Design: Longitudinal study based on medical examinations and self-ratings. Method: Path analysis along with latent growth curve analysis was based on the German study about the relationship of physical activity, fitness and health (1992–2010). Data were collected from 495 adults (243 women) with an average age of 45.03 years in 1992 (SD = 7.45). Participants were randomly selected from the official registers of local residents' registration offices in the community of Bad Schönborn. Results: For the mean PF and health levels in 1992, direct and indirect influences were shown on four levels including socioeconomic status and immigration on the first level, outcome expectations and stress coping strategies on the second level as well as eating patterns and physical activity on the third level; furthermore, the course of PF and the course of health (from 1992 until 2010) were affected by the initial behaviors (physical activity and eating patterns in 1992); finally PF and health were not related. Conclusions: Influences on four levels provided evidence for the complexity of PF and health (outcome level). Initial behaviors predicted current PF and health status, as well as their course. Thus, preventive measures should ensure that healthy behaviors are adopted early in adulthood. [Copyright &y& Elsevier]

Aims The aim of this study was to estimate the frequencies and patterns of skin care and applied skin care products in the home care nursing setting in Germany. Background Skin care belongs to the core activities of nursing practice. Especially in aged and long-term care settings, clients are vulnerable to various skin conditions. Dry skin is one of the most prevalent problems. Using mild skin cleansers and the regular application of moisturizing leave-on products is recommended. Until today, there are no quantitative empirical data about nursing skin care practice at home in the community. Design A multicentre cross-sectional study was conducted in July 2012. Methods Home care clients from the German home care nursing setting were randomly selected. Instructed nurse raters performed the data collection using standardized forms. Variables included demographics, skin care needs and skin caring activities. Results Approximately 60% of home care clients received skin care interventions. The majority were washed and two-thirds received a leave-on product once daily. There was large heterogeneity in cleansing and skin care product use. Most often the product labels were unknown or product types were selected haphazardly. Conclusion Skin care interventions play a significant role in home care and nurses have a considerable responsibility for skin health. Skin care provided does not meet recent recommendations. The importance of targeted skin cleansing and care might be underestimated. There are a confusing variety of skin care products available and often the labels provide little information regarding the ingredients or guidance about how they affect skin health. [ABSTRACT FROM AUTHOR]

Aims: First, the influence of determinants on the waiting times of chronically ill patients in the ambulatory sector is investigated. The determinants are subdivided into four groups: (1) need, (2) socio-economic factors, (3) health system and (4) patient time pressures. Next, the influence of waiting times on the annual number of consultations is examined to assess whether the existing variation in waiting times influences the frequency of medical examinations. The waiting times of chronically ill patients are analysed since regular ambulatory care for this patient group could both improve treatment outcomes and lower costs. Data sources: Individual data from the 2010 Representative Survey conducted by the National Association of Statutory Health Insurance Physicians (KBV) together with regional data from the Federal Office of Construction and Regional Planning. Study design: This is a retrospective observational study. The dependent variables are waiting times in the ambulatory sector and the number of consultations of General Practitioners (GPs) and specialist physicians in the year 2010. The explanatory variables of interest are 'need' and 'health system' in the first model and 'length of waiting times' in the second. Negative binomial models with random effects are used to estimate the incidence rate ratios of increased waiting times and number of consultations. Subsequently, the models are stratified by urban and rural areas. Results: In the pooled regression the factor 'privately insured' shortens the waiting time for treatment by a specialist by approximately 28% (about 3 days) in comparison with members of the statutory health insurance system. The category of insurance has no influence on the number of consultations of GPs. In addition, the regression results stratified by urban and rural areas show that in urban areas the factor 'privately insured' reduces the waiting time for specialists by approximately 35% (about 3.3 days) while in rural areas there is no evidence of statistical influence. In neither of the models, however, does the waiting time have a documentable effect on the number of consultations in the ambulatory sector. Conclusions: In our random sample, characteristics of the health care system have an influence on the waiting time for specialists, but the waiting time has no documentable effect on the number of consultations in the ambulatory sector. In the present analysis this applies to consultations of both GPs and specialists. Nevertheless, it does not rule out the possibility that the length of waiting times might influence the treatment outcomes of certain patient populations. [ABSTRACT FROM AUTHOR]

Aims and objectives The aim of this research is to investigate the degree of distress experienced by nurses in response to the challenging behaviour of nursing home residents (residents' challenging behaviour) and their impact on nurses individual resources (general health, burnout and work ability). Background Because of the increasing and ageing population of nursing home residents, professional nursing care faces several challenges. One highly prevalent issue among nursing home residents is the so-called 'challenging behaviour'. However, to date, 'challenging behaviour' has not yet been recognised as an occupational stressor, and the extent of the impact of 'challenging behaviour' on nurses' well-being and functioning is not well understood. Design Cross-sectional study. Method Self-report questionnaire data collected from 731 registered nurses and nursing aides in 56 German nursing homes were used in a secondary data analysis. The level of residents' challenging behaviour-related distress that nurses experienced was assessed using a scale consisting of nine questions. Validated instruments were used for the assessment of individual resources. Results The mean score for residents' challenging behaviour-related distress was 41·3 ( SD 21·2). Twenty-seven per cent of all nurses reported over 50 residents' challenging behaviour. Residents' challenging behaviour had a significant impact on all three measures of individual resources. Specifically, nurses exposed to frequent residents' challenging behaviour reported a significantly lower quality of general health, reduced workability and high burnout levels. Conclusion Our findings indicate that residents' challenging behaviour-related distress is a significant work place stressor for nurses in nursing homes with a clear impact on general health, the risk of burnout and work ability. Relevance to clinical practice Our findings suggest that residents' challenging behaviour is a stressor for nurses in nursing homes. Further scientific and practical attention is necessary from the point of view of working conditions for nurses. The development of preventive concepts for nursing staff and residents is recommended. [ABSTRACT FROM AUTHOR]

Background Several studies have assessed the effect of cost sharing on health service utilization (HSU), mostly in the USA. Results are heterogeneous, showing different effects. Whereas previous studies compared insurants within one health care system but different modes of insurance, we aimed at comparing two different health care systems in Europe: Germany and Switzerland. Furthermore, we assessed the impact of cost sharing depending on socio-demographic factors as well as health status. Methods Two representative samples of 5197 Swiss insurants with and 5197 German insurants without cost sharing were used to assess the independent association between cost sharing and the use of outpatient care. To minimize confounding, we performed cross-sectional analyses between propensity score matched Swiss and German insurants. We investigated subgroups according to health and socio-economic status to assess a potential social gradient in HSU. Results We found a significant association between health insurance scheme and the use of outpatient services. German insurants without cost sharing (visit rate: 4.8 per year) consulted a general practitioner or specialist more frequently than Swiss insurants with cost sharing (visit rate: 3.0 per year; P < 0.01). Subgroup analyses showed that vulnerable populations were differently affected by cost sharing. In the group of respondents with poor health and low socio-economic status, the cost-sharing effect was strongest. Conclusion Cost-sharing models reduce HSU. The challenge is to create cost-sharing models which do not preclude vulnerable populations from seeking essential health care. [ABSTRACT FROM AUTHOR]

Objectives To determine the efficacy of multimodal, nondrug therapy on symptoms of dementia and need for care in institutionalized individuals with degenerative dementia. Design Randomized, controlled, longitudinal trial. Data were analyzed using multiple linear regression. Setting Five German nursing homes. Participants One hundred thirty-nine nursing home residents with primary degenerative dementia ( Mini- Mental State Examination score < 24). Intervention The 6-month intervention comprised three components: motor stimulation, activities of daily living, and cognitive stimulation ( MAKS). Groups of 10 patients led by two therapists participated in the standardized intervention for 2 hours, 6 days a week. The intervention was described in detail in an intervention manual. Adherence to the manual was high. Controls received treatment as usual. Measurements Overall geriatric symptoms were recorded using the Nurses' Observation Scale for Geriatric Patients, functional independence using the Barthel Index, and care time using the Resource Utilization in Dementia- Formal Care. Results Of 646 individuals screened, 146 were eligible, and 130 were included in the intention-to-treat analysis. At 6 months, results of the per-protocol analysis (n = 119) showed improvement in overall dementia symptoms in the MAKS group and no change in the control group (adjusted mean difference ( AMD) = −6.8, 95% confidence interval ( CI) = −10.3 to −3.3; P < .001, Cohen d = 0.66). This effect was greatest on the social behavior ( AMD = −1.9, 95% CI = −2.9 to −0.8; P < .001; Cohen d = 0.54) and instrumental activity of daily living ( IADL) ( AMD = −1.4, 95% CI = −2.5 to −0.30; P = .01; Cohen d = 0.43) subscales. No effect was seen on functional independence or total care time. Conclusion This 6-month nondrug multimodal intervention improved dementia symptoms in nursing home residents, especially in social behavior and IADL capabilities. Registration Identifier: ISRCTN87391496. [ABSTRACT FROM AUTHOR]