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Autonomy (defined as self-governance; not equivalent to independence) is relevant to well-being and psychological functioning. However, there is a lack of research on individuals aged >85 years and their perception of autonomy when receiving informal care. This study aims to answer the question if and how the receipt of informal care is associated with perceived autonomy of individuals aged over 85 years.A cross-sectional study was conducted with data from follow-up 9 of the AgeQualiDe study (2015/2016), which is a multi-centric prospective cohort study in Germany. The analytical sample included 570 participants aged >85 years and with a score of ≥ 19 on the Mini-Mental-State-Examination. Perceived autonomy was assessed with the Perceived Autonomy in Old Age Scale. Receipt of care was assessed as performance of at least one care task (help with basic and instrumental activities of daily living, and supervision) by relatives or friends. Sociodemographic information, mental health, functional level and receipt of professional ambulatory care were controlled for.Unadjusted and adjusted linear regression analyses indicated a significant negative association between receipt of informal care and perceived autonomy. The results remained stable in sensitivity analyses; no significant interaction effect was found for gender or education.Findings indicate that informal care recipients aged >85 years perceive lower autonomy compared to those not receiving care. Additional or other forms of support, and improving the care relationship and communication might be considered to support autonomy of care recipients aged >85 years.

Objectives The aims of our study were to describe the effect of the COVID-19 pandemic and lockdown on primary care in Germany regarding the number of consultations, the prevalence of specific reasons for consultation presented by the patients, and the frequency of specific services performed by the GP. Methods We conducted a longitudinal observational study based on standardised GP interviews in a quota sampling design comparing the time before the COVID-19 pandemic (12 June 2015 to 27 April 2017) with the time during lockdown (21 April to 14 July 2020). The sample included GPs in urban and rural areas 120 km around Hamburg, Germany, and was stratified by region type and administrative districts. Differences in the consultation numbers were analysed by multivariate linear regressions in mixed models adjusted for random effects on the levels of the administrative districts and GP practices. Results One hundred ten GPs participated in the follow-up, corresponding to 52.1% of the baseline. Primary care practices in 32 of the 37 selected administrative districts (86.5%) could be represented in both assessments. At baseline, GPs reported 199.6 ± 96.9 consultations per week, which was significantly reduced during COVID-19 lockdown by 49.0% to 101.8 ± 67.6 consultations per week (p p Conclusions We observed a dramatic reduction of the number of consultations in primary care. This effect was independent of age, sex and specialty of the GP and independent of the practice location in urban or rural areas. Consultations for complaints like low back pain, gastrointestinal complaints, vertigo or fatigue and services like house calls/calls at nursing homes, wound treatments, pain therapy or screening examinations for the early detection of chronic diseases were particularly affected.

Background Patients with multiple long-term conditions often face a variety of challenges arising from the requirements of their health care. Knowledge of perceived treatment burden is crucial for optimizing treatment. In this study, we aimed to create a German version of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and to evaluate its validity. Methods The steps to translate the MTBQ included forward/back translation, cognitive interviews (n = 6) and a pilot test (n = 7). Psychometric properties of the scale were assessed in a cross-sectional survey with primary care patients aged 65 and older with at least 3 long-term conditions (n = 344). We examined the distribution of responses, dimensionality, internal reliability and construct validity. Results Cognitive interviewing and piloting led to minor modifications and showed overall good face validity and acceptability. As expected, we observed a positively skewed response distribution for all items. Reliability was acceptable with McDonald’s omega = 0.71. Factor analysis suggested one common factor while model fit indices were inconclusive. Predefined hypotheses regarding the construct validity were supported by negative associations between treatment burden and health-related quality of life, self-rated health, social support, patient activation and medication adherence, and positive associations between treatment burden and number of comorbidities. Treatment burden was found to be higher in female participants (Mdn1 = 6.82, Mdn2 = 4.55; U = 11,729, p = 0.001) and participants with mental health diagnoses (Mdn1 = 9.10, Mdn2 = 4.55; U = 3172, p = 0.024). Conclusions The German MTBQ exhibited good psychometric properties and can be used to assess the perceived treatment burden of patients with multimorbidity.

Objectives Previous studies have observed protective effects of high mental demands at work on cognitive functioning and dementia risk. However, it is unclear what types of demands drive this effect and whether this effect is subject to a person's genetic risk. We investigated to what extent eight different types of mental demands at work together with the APOE e4 allele, a major risk gene for late-onset Alzheimer's disease, affect cognitive functioning in late life. Methods/design The population-based German Study on Ageing, Cognition, and Dementia in Primary Care Patients (AgeCoDe, n=2,154) followed cognitively healthy individuals aged 75 years and older in seven assessment waves. Cognitive functioning was assessed via the mini-mental status examination. Results Mixed-effects modeling (adjusted for education, gender, marital status, stroke, depression, and diabetes) indicated that participants who had an occupational history of working in jobs with high compared to low demands in 'Language & Knowledge', 'Pattern detection', 'Information processing', and 'Service' had a slower cognitive decline. APOE e4-allele carriers had an accelerated cognitive decline, but this decline was significantly smaller if they had a medium compared to a low level of demands in contrast to non-carriers. Conclusions Our longitudinal observations suggest that cognitive decline could be slowed by an intellectually enriched lifestyle even in risk gene carriers. Fostering intellectual engagement throughout the life-course could be a key prevention initiative to promote better cognitive health in old age. This article is protected by copyright. All rights reserved.

Background In most countries, the general practitioner (GP) is the first point of contact in the healthcare system and coordinator of healthcare. However, in Germany it is possible to consult an outpatient specialist even without referral. Coordination by a GP might thus reduce health expenditures and inequalities in the healthcare system. The study describes the patients’ willingness/commitment to use the GP as coordinator of healthcare and identifies regional and patient-related factors associated with the aforementioned commitment to the GP. Methods Cross-sectional observational study using a standardised telephone patient survey in northern Germany. All counties and independent cities within a radius of 120 km around Hamburg were divided into three regional categories (urban areas, environs, rural areas) and stratified proportionally to the population size. Patients who had consulted the GP within the previous three months, and had been patients of the practice for at least three years were randomly selected from medical records of primary care practices in these districts and recruited for the study. Multivariate linear regression models adjusted for random effects at the level of federal states, administrative districts and practices were used as statistical analysis methods. Results Eight hundred eleven patients (25.1%) from 186 practices and 34 administrative districts were interviewed. The patient commitment to a GP attained an average of 20 out of 24 possible points. Significant differences were found by sex (male vs. female: + 1.14 points, p p = 0.043), education (high vs. low: − 1.74, p p = 0.004), regional category (urban areas: − 0.85, p = 0.022; environs: − 0.80, p = 0.045) and healthcare utilisation (each GP contact: + 0.30, p p = 0.018). Professional situation and age were not significantly associated with the GP commitment. Conclusion On average, the patients’ commitment to their GP was relatively strong, but there were large differences between patient groups. An increase in the patient commitment to the GP could be achieved through better patient information and targeted interventions, e.g. to women or patients from regions of higher urban density. Trial registration The study was registered in ClinicalTrials.gov (NCT02558322).

ObjectivesThis study aimed to explore the association between patient activation and patients’ experience of care among an elderly multimorbid population in Germany.DesignCross-sectional study.SettingPrimary care practices in two German settings.Participants346 patients with 3 or more chronic conditions aged 65 years and over from 36 primary care practices.Outcome measuresPatient activation was measured with the patient activation measure (PAM). To assess patient experiences with primary care, a set of questions concerning domains of primary care were included. Multilevel regression analyses were performed to examine which domains of care were associated with patient activation.ResultsOut of 1243 invited patients, a total of 346 took part in the study (participation rate 27.8 %). Mean PAM score was 76.1. Across all patients, 3.8% achieved PAM level 1, 7.5% level 2, 27.2% level 3% and 60.7% level 4. PAM scores suggest a highly activated patient group. In the regression analysis, three out ten domains of patients’ experiences showed an association with patient activation. The domains ‘being involved in decision as much as desired’ (B=−8.56, p=0.012) and ‘receiving a self-management plan’ (B=6.51, p=0.051) were associated with higher patient activation scores. Patients with an up-to-date medication plan had lower patient activation scores (B=−12.01, p=0.041).ConclusionSpecific domains of primary care were found to be associated with patient activation. To enhance patient activation, primary care physicians may increase involvement of patients in decisions. Future research should examine the causality of these associations.Trial registration numberDRKS00015718.

Background Patient numbers in emergency departments are on the rise. The DEMAND intervention aims to improve the efficacy of emergency services by computer-assisted structured initial assessment assigning patients to emergency departments or primary care practices. The aims of our study were to evaluate patient satisfaction with this intervention and to analyse if reduced patient satisfaction is predicted by sociodemographic data, health status or health literacy. Methods We conducted a cross-sectional patient survey in emergency departments and co-located primary care practices. Each intervention site was planned to participate for two observation periods, each with a duration of one full week. Study participants were recruited by the local staff. The patients filled out a written questionnaire during their waiting time. Patient satisfaction was assessed by agreement to four statements on a four point Likert scale. Predictors of patient satisfaction were identified by multilevel, multivariable logistic regression models adjusted for random effects at the intervention site level. Results The sample included 677 patients from 10 intervention sites. The patients had a mean age of 38.9 years and 59.0% were women. Between 67.5% and 55.0% were fully satisfied with aspects of the intervention. The most criticised aspect was that the staff showed too little interest in the patients’ personal situation. Full satisfaction (“clearly yes” to all items) was reported by 44.2%. Reduced patient satisfaction (at least one item rated as “rather yes”, “rather no”, “clearly no”) was predicted by lower age (odds ratio 0.79 for ten years difference, 95% confidence interval 0.67/0.95, p = 0.009), presenting with infections (3.08,1.18/8.05,p = 0.022) or injuries (3.46,1.01/11.82,p = 0.048), a higher natural logarithm of the symptom duration (1.23,1.07/1.30,p = 0.003) and a lower health literacy (0.71 for four points difference, 0.53/0.94,p = 0.019). Conclusions The patients were for the most part satisfied with the intervention. Assessment procedures should be evaluated a) regarding if all relevant patient-related aspects are included; and whether patient information can be improved b) for patients with strong opinions about cause, consequences and treatment options for their health problem; and c) for patients who have problems in the handling of information relevant to health and healthcare. Trial registration German Clinical Trials Register (https://www.drks.de/drks_web/setLocale_EN.do) no. DRKS00017014.

Background and Objectives Providing health care for older adults with multimorbidity is often complex, challenging, and prone to fragmentation. Although clinical decision making should take into account treatment interactions, individual burden, and resources, current approaches to assessing quality of care mostly rely on indicators for single conditions. The aim of this project was to develop a set of generic quality indicators for the management of patients aged 65 and older with multimorbidity that can be used in both health care research and clinical practice. Research Design and Methods Based on the findings of a systematic literature review and eight focus groups with patients with multimorbidity and their family members, we developed candidate indicators. Identified aspects of quality were mapped to core domains of health care to obtain a guiding framework for quality-of-care assessment. Using nominal group technique, indicators were rated by a multidisciplinary expert panel (n = 23) following standardized criteria. Results We derived 47 candidate quality indicators from the literature and 4 additional indicators from the results of the focus groups. The expert panel selected a set of 25 indicators, which can be assigned to the levels of patient factors, patient–provider communication, and context and organizational structures of the conceptual framework. Discussion and Implications We developed a comprehensive indicator set for the management of multimorbidity that can help to highlight areas with potential for improving the quality of care and support application of multimorbidity guidelines. Furthermore, this study may serve as a blueprint for participatory designs in the development of quality indicators.

BackgroundPrevalence of people with multimorbidity rises. Multimorbidity constitutes a challenge to the healthcare system, and treatment of patients with multimorbidity is prone to high-quality variations. Currently, no set of quality indicators (QIs) exists to assess quality of care, let alone incorporating the patient perspective. We therefore aim to identify aspects of quality of care relevant to the patients’ perspective and match them to a literature-based set of QIs.MethodsWe conducted eight focus groups with patients with multimorbidity and three focus groups with patients’ relatives using a semistructured guide. Data were analysed using Kuckartz’s qualitative content analysis. We derived deductive categories from the literature, added inductive categories (new quality aspects) and translated them into QI.ResultsWe created four new QIs based on the quality aspects relevant to patients/relatives. Two QIs (patient education/self-management, regular updates of medication plans) were consented by an expert panel, while two others were not (periodical check-ups, general practitioner-coordinated care). Half of the literature-based QIs, for example, assessment of biopsychosocial support needs, were supported by participants’ accounts, while more technical domains regarding assessment and treatment regimens were not addressed in the focus groups.ConclusionWe show that focus groups with patients and relatives adding relevant aspects in QI development should be incorporated by default in QI development processes and constitute a reasonable addition to traditional QI development. Our QI set constitutes a framework for assessing the quality of care in the German healthcare system. It will facilitate implementation of treatment standards and increase the use of existing guidelines, hereby helping to reduce overuse, underuse and misuse of healthcare resources in the treatment of patients with multimorbidity.Trial registration numberGerman clinical trials registry (DRKS00015718), Pre-Results.

Background Low health literacy is believed to be associated with behaviours that increase the risk of type 2 diabetes. But there is limited knowledge on the relation between health literacy (HL) and diabetes risk, and whether improving HL could be a potential prevention strategy. Therefore, the main purpose of this study was to examine the link between HL and diabetes risk among non-diabetic adults. Methods We used data from the Hamburg Diabetes Prevention Survey, a population-based cross-sectional study in Germany. One thousand, two hundred and fifty-five non-diabetic subjects aged 18–60 years were eligible. The German Diabetes Risk Score (GDRS, ranging 0 to 123 points) was used to determine the individual risk of type 2 diabetes. The short version of the European Health Literacy Questionnaire (HLS-EU-Q16, ranging 0 to 16 points) was applied to assess the individual self-reported HL. Subjects were asked to self-estimate their diabetes risk, which was then compared with the calculated GDRS. Descriptive statistics were calculated to investigate group differences in the GDRS and self-estimated diabetes risk. Linear as well as logistic regression models were performed to analyse potential influencing variables of the GDRS as well as incorrect self-estimated diabetes risk. In three nested statistical models for each outcome, these analyses were adjusted for age, gender, educational level and the presence of chronic conditions. Results According to the criteria of the GDRS, 996 (79.4%) subjects showed “low risk”, 176 (14.0%) “still low risk”, 53 (4.2%) “elevated risk”, and 30 (2.4%) “high to very high risk” to develop type 2 diabetes within the next 5 years. In the statistical models including all control variables, subjects with “inadequate HL” scored 2.38 points higher on the GDRS (95% CI 0.378 to 4.336; P = 0.020) and had a 2.04 greater chance to estimate their diabetes risk incorrectly (OR 2.04; 95% CI 1.33 to 3.14; P = 0.001) compared to those with “sufficient HL”. Conclusion The risk of type 2 diabetes is increased in people with inadequate self-reported HL. People with high diabetes risk and inadequate HL might be provided with educational programs to improve diabetes knowledge and reduce behavioural risk factors.

Background It is almost unknown whether the driving status is associated with HRQOL among individuals in highest age. Aims Based on a multicenter prospective cohort study, the objective of this study was to examine whether the driving status is associated with health-related quality of life (HRQOL) among the oldest old in Germany. Methods Cross-sectional data from follow-up wave 9 (n = 544) were derived from the “Study on Needs, health service use, costs and health-related quality of life in a large sample of oldest-old primary care patients (85+)” (AgeQualiDe). Average age was 90.3 years (± 2.7; 86 to 101 years). The current driver status (no; yes) was used in our analysis. The EuroQoL EQ-5D questionnaire was used to assess HRQOL in this study. Results Regression analysis showed that being a current driver was associated with the absence of problems in ‘self-care’ [OR 0.41 (95%-CI 0.17 to 0.98)], and ‘usual activities’ [OR 0.48 (0.26 to 0.90)], whereas it was not significantly associated with problems in ‘pain/discomfort’ [OR 0.82 (0.47 to 1.45)] and ‘anxiety/depression’ [OR 0.71 (0.36 to 1.39)]. Being a current driver was marginally significantly associated with the absence of problems in ‘mobility’ [OR 0.60 (0.34 to 1.06)]. While being a current driver was not associated with the EQ-VAS in the main model, it was positively associated with the driving status (β = 5.00, p Discussion Our findings provide first evidence for an association between driving status and HRQOL among the oldest old. Conclusions Future longitudinal studies are required to evaluate a possible causal relationship between driving status and HRQOL in very old individuals.

ObjectivesThe aims of our study were to describe the disease spectrum of refugees, to analyse to what extent their healthcare needs could be met in an outpatient primary care walk-in clinic and which cases required additional services from secondary care (ie, outpatient specialists or hospitals).DesignRetrospective longitudinal observational study.SettingThe study was based on routine data from a walk-in clinic in the largest central first reception centre in Hamburg, Germany between 4 November 2015 and 21 July 2016.Participants1467 asylum seekers with 4006 episodes of care (ie, distinctive health problems) resulting in 5545 consultations. The patients were 60% men and had a mean age of 23.2 years. About 90% of the patients were from Central Asia or from the Middle East and North Africa.Primary and secondary outcome measuresThe endpoint of our analyses was referral to secondary care. Time to event was defined as days under treatment until the first referral. Predictor variables were the patients’ diagnoses grouped in 46 categories. The data set was analysed by Cox regression allowing for multiple failure times per patient. This analysis was adjusted for age, sex and country of origin.ResultsReferrals to secondary care occurred in 15.5% of the episodes. The diagnosis groups with the highest referral rates were ‘eye’ (HR 4.9; 95% CI 3.12 to 7.8; p≤0.001), ‘teeth/gum symptom/complaint or disease’ (3.51; 2.52 to 4.9; p≤0.001) and ‘urological system/female or male genital’ (2.50; 1.66 to 3.77; p≤0.001). Age, sex and country of origin had no significant effect on time until referral.ConclusionsIn most cases, the walk-in clinic physicians could provide first-line medical care for the health problems of patients not integrated in the German healthcare system. Additional resources were needed particularly not only for visual impairment and dental problems but also for psychological disorders, antenatal care and certain infections and injuries.

Background From 2015 to 2016 Germany faced an influx of 1.16 million asylum seekers. In the state of Hamburg Primary Care walk-in clinics (PCWC) were commissioned at refugee camps because the high number of residents (57,000 individuals) could not be provided with access to regular healthcare services. Our study aims were (1) to describe the utilization of a PCWC by camp residents, (2) to compare episodes of continuous care with shorter care episodes and (3) to analyse which diagnoses predict episodes of continuous care in this setting. Methods A retrospective longitudinal observational study was conducted by reviewing all anonymized electronic medical records of a PCWC that operated from 4th November 2015 to 22nd July 2016 at a refugee camp in Hamburg. Episodes of care (EOC) were extracted based on the international classification of primary care-2nd edition (ICPC-2). Outcome parameters were episode duration, principal diagnoses, and medical procedures. Results We analysed 5547 consultations of 1467 patients and extracted 4006 EOC. Mean patient age was 22.7 ± 14.8 years, 37.3% were female. Most common diagnoses were infections (44.7%), non-communicable diseases (22.2%), non-definitive diagnoses describing symptoms (22.0%), and injuries (5.7%). Most patients (52.4%) had only single encounters, whereas 19.8% had at least one EOC with a duration of ≥ 28 days (defined as continuous care). Several procedures were more prevalent in EOC with continuous care: Blood tests (5.2 times higher), administrative procedures (4.3), imaging (3.1) and referrals to secondary care providers (3.0). Twenty prevalent ICPC-2-diagnosis groups were associated with continuous care. The strongest associations were endocrine/metabolic system and nutritional disorders (hazard ratio 5.538, p Conclusion A wide spectrum of acute and chronic health conditions could be treated at a GP-led PCWC with few referrals or use of medical resources. But we also observed episodes of continuous care with more use of medical resources and referrals. Therefore, we conclude that principles of primary care like continuity of care, coordination of care and management of symptomatic complaints could complement future healthcare concepts for refugee camps.

To describe health status and health state utilities measured by the EQ-5D-3L in a population-based sample of individuals aged 85 + in Germany, and to analyze associations with basic socio-demographic variables. Cross-sectional data from follow-up wave 7 (n = 761) of the German AgeCoDe Study were used. The EQ-5D-3L questionnaire was used to record problems in five health dimensions, its visual analogue scale (EQ VAS) was used to record self-rated health status, and the German EQ-5D-3L index was used to derive health state utilities. Mean age of respondents was 88.9 years (SD 2.9; range 85 to 100), 67.4% were female. 81.9% reported problems in at least one of the EQ-5D dimensions, with 15.3% reporting extreme problems. Most frequent were problems with pain/discomfort (64.8%), followed by mobility (62.5%), usual activities (42.6%), self-care (28.2%), and anxiety/depression (20.5%). Mean EQ VAS score was 62.4 (SD 18.8), and mean EQ-5D index was 0.77 (SD 0.24). Multiple regression analysis showed associations of problem frequency in various EQ-5D dimensions with age, gender, living situation, marital status, and education. The EQ VAS score was negatively associated with age (β = − 0.56; p

Background Among other factors, the patients’ consultation reasons and GPs’ spectrum of services determine the process and outcome of the medical treatment. So far, however, there has been little information on differences in reasons for consultation and GPs’ services between urban and rural areas. Our study’s goal was thus to investigate these factors in relation to the regional location of GPs’ practices. Methods We conducted a cross-sectional observational study based on standardised GP interviews in a quota sampling design. All counties and independent cities within a radius of 120 km around Hamburg were divided into three regional categories (urban area, environs, rural area) and stratified proportionally to the population size. Differences in the number of reasons for consultation and services were analysed by multivariate linear regressions in mixed models adjusted for random effects on the levels of the German federal states and administrative districts. Differences in individual consultation reasons and services were identified by logistic regression via stepwise forward and backward selection. Results Primary care practices in 34 of the 37 selected administrative districts (91.9%) were represented in the dataset. In total, 211 GPs were personally interviewed. On average, GPs saw 344 patients per month with a slightly higher number of patients in rural areas. They reported 59.1 ± 15.4 different reasons for consultation and 30.3 ± 3.9 different services. There was no statistically significant regional variation in the number of different consultation reasons, but there was a broader service spectrum by rural GPs (ß = − 1.42; 95% confidence interval − 2.75/− 0.08; p = 0.038) which was statistically explained by a higher level of medical training. Additionally, there were differences in the frequency of individual consultation reasons and services between rural and urban areas. Conclusion GPs in rural areas performed more frequently services usually provided by medical specialists in urban areas. This might be caused by a low availability of specialists in rural areas. The association between medical training and service spectrum might imply that GPs compensate the specific needs of their patients by completing advanced medical training before or after setting up a medical practice. Trial registration The study was registered in ClinicalTrials.gov (NCT02558322).

To clarify the link between depressive symptoms and functional impairment among the oldest old longitudinally.Longitudinal data (n = 1,272) were taken from a multicenter prospective cohort study ("Study on Needs, health service use, costs and health-related quality of life in a large sample of oldest-old primary care patients (85+)" [AgeQualiDe]). Functional decline was assessed using the Lawton and Brody Instrumental Activities of Daily Living scale, and the Geriatric Depression Scale was used to measure depressive symptoms.While initial increases in depressive symptoms were associated with subsequent increases in functional impairment, initial increases in functional impairment were not associated with subsequent increases in depressive symptoms.Our results stress the relevance of increases in depressive symptoms for upcoming functional decline among the oldest old. Further longitudinal studies are required to replicate our findings.Analyse der Beziehung zwischen depressiven Symptomen und funktionellen Beeinträchtigungen bei Hochaltrigen (85+) im Längsschnitt.Drei Wellen der multizentrischen prospektiven Kohortenstudie AgeQualiDe wurden genutzt (n = 1272 Beobachtungen). Die Geriatrische Depressionsskala wurde zur Erfassung depressiver Symptome verwendet. Die Instrumental Activities of Daily Living von Lawton und Brody wurde zur Messung funktioneller Beeinträchtigungen eingesetzt.Anfängliche Steigerungen in depressiven Symptomen gehen mit späteren Steigerungen funktioneller Beeinträchtigungen einher. Hingegen hängen anfängliche Steigerungen funktioneller Beeinträchtigungen nicht mit späteren Steigerungen in depressiven Symptomen zusammen.Unsere Ergebnisse deuten darauf hin, dass anfängliche Steigerungen depressiver Symptome mit einer Zunahme funktioneller Beeinträchtigungen bei Hochaltrigen zusammenhängen.

Introduction: There is a lack of studies investigating the link between time-varying factors associated with changes in frailty scores in very old age longitudinally. This is important because the level of frailty is associated with subsequent morbidity and mortality. Objective: To examine time-dependent predictors of frailty among the oldest old using a longitudinal approach. Methods: Longitudinal data were drawn from the multicentre prospective cohort study “Study on Needs, health service use, costs and health-related quality of life in a large sample of oldest-old primary care patients (85+)” (AgeQualiDe), covering primary care patients aged 85 years and over. Three waves were used (from follow-up, FU, wave 7 to FU wave 9 [with 10 months between each wave]; 1,301 observations in the analytical sample). Frailty was assessed using the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale (CFS). As explanatory variables, we included sociodemographic factors (marital status and age), social isolation as well as health-related variables (depression, dementia, and chronic diseases) in a regression analysis. Results: In total, 18.9% of the individuals were mildly frail, 12.4% of the individuals were moderately frail, and 0.4% of the individuals were severely frail at FU wave 7. Fixed effects regressions revealed that increases in frailty were associated with increases in age (β = 0.23, p < 0.001), and dementia (β = 0.84, p < 0.01), as well as increases in chronic conditions (β = 0.03, p = 0.058). Conclusion: The study findings particularly emphasize the importance of changes in age, probably chronic conditions as well as dementia for frailty. Future research is required to elucidate the underlying mechanisms. Furthermore, future longitudinal studies based on panel regression models are required to confirm our findings.

Zusammenfassung Ziel der Studie Analyse der Beziehung zwischen depressiven Symptomen und funktionellen Beeinträchtigungen bei Hochaltrigen (85+) im Längsschnitt. Methodik Drei Wellen der multizentrischen prospektiven Kohortenstudie AgeQualiDe wurden genutzt (n = 1272 Beobachtungen). Die Geriatrische Depressionsskala wurde zur Erfassung depressiver Symptome verwendet. Die Instrumental Activities of Daily Living von Lawton und Brody wurde zur Messung funktioneller Beeinträchtigungen eingesetzt. Ergebnisse Anfängliche Steigerungen in depressiven Symptomen gehen mit späteren Steigerungen funktioneller Beeinträchtigungen einher. Hingegen hängen anfängliche Steigerungen funktioneller Beeinträchtigungen nicht mit späteren Steigerungen in depressiven Symptomen zusammen. Schlussfolgerung Unsere Ergebnisse deuten darauf hin, dass anfängliche Steigerungen depressiver Symptome mit einer Zunahme funktioneller Beeinträchtigungen bei Hochaltrigen zusammenhängen.

Background Initiatives such as “Choosing Wisely” in the USA and “Smarter Medicine” in Switzerland have published lists of widely overused health care services. The German initiative “Choosing Wisely Together (Gemeinsam Klug Entscheiden)” follows this example. The goal of our study was to prioritize important recommendations against the overuse and underuse of health care services. The final list of recommendations will be published in the German guideline “Protection against the overuse and underuse of health care”. Methods First, a multidisciplinary expert panel established a catalogue of prioritization criteria. Second, we extracted all the recommendations from evidence- and consensus-based German College of General Practice and Family Medicine (DEGAM) guidelines and National Health Care Guidelines (NVL). Third, the recommendations were rated by two independent panels (general practitioners and other health care professionals involved/not involved in guideline development). The prioritization process was finalized in a consensus conference held by DEGAM’s Standing Guideline Committee (SLK). Results Eleven prioritization criteria were established. A total of 782 recommendations were extracted and rated by 98 physicians and other health care professionals in a survey. In the voting process, more than 80% of the recommendations were eliminated. After the final consensus conference, twelve recommendations from DEGAM guidelines, nine DEGAM addenda and 17 NVL recommendations were chosen for inclusion in the guideline, for a total of 38 recommendations. Conclusion The selection procedure proved helpful in identifying the highest priority recommendations with which to combat the overuse and underuse of health care services. To date, in Germany there has been no attempt to compile such a list by using a systematic and transparent methodology. Hence, the guideline that results from this process can fill an important gap.

Background Traumatic events like critical illness and intensive care are threats to life and bodily integrity and pose a risk factor for posttraumatic stress disorder (PTSD). PTSD affects the quality of life and morbidity and may increase health-care costs. Limited access to specialist care results in PTSD patients being treated in primary care settings. Narrative exposure therapy (NET) is based on the principles of cognitive behavioral therapy and has shown positive effects when delivered by health-care professionals other than psychologists. The primary aims of the PICTURE trial (from “PTSD after ICU survival”) are to investigate the effectiveness and applicability of NET adapted for primary care with case management in adults diagnosed with PTSD after intensive care. Methods/design This is an investigator-initiated, multi-center, primary care-based, randomized controlled two-arm parallel group, observer-blinded superiority trial conducted throughout Germany. In total, 340 adult patients with a total score of at least 20 points on the posttraumatic diagnostic scale (PDS-5) 3 months after receiving intensive care treatment will be equally randomized to two groups: NET combined with case management and improved treatment as usual (iTAU). All primary care physicians (PCPs) involved will be instructed in the diagnosis and treatment of PTSD according to current German guidelines. PCPs in the iTAU group will deliver usual care during three consultations. In the experimental group, PCPs will additionally be trained to deliver an adapted version of NET (three sessions) supported by phone-based case management by a medical assistant. At 6 and 12 months after randomization, structured blinded telephone interviews will assess patient-reported outcomes. The primary composite endpoint is the absolute change from baseline at month 6 in PTSD symptom severity measured by the PDS-5 total score, which also incorporates the death of any study patients. Secondary outcomes cover the domains depression, anxiety, disability, health-related quality-of-life, and cost-effectiveness. The principal analysis is by intention to treat. Discussion If the superiority of the experimental intervention over usual care can be demonstrated, the combination of brief NET and case management could be a treatment option to relieve PTSD-related symptoms and to improve primary care after intensive care. Trial registration ClinicalTrials.gov, NCT03315390. Registered on 10 October 2017. German Clinical Trials Register, DRKS00012589. Registered on 17 October 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-2853-7) contains supplementary material, which is available to authorized users.

ObjectivesAim of this study was to analyse if subjectively perceived treatment urgency of patients in emergency departments is associated with self-reported health literacy and the willingness to use the general practitioner (GP) as coordinator of treatment.DesignA multicentre, cross-sectional, observational study.SettingEmergency departments in five hospitals. Each hospital was visited 14 times representing two 8-hour shifts on each day of the week. Calendar dates were randomly assigned.ParticipantsAll patients of legal age registered at the emergency department or hospital reception desk. Exclusion criteria included immediate or very urgent need of treatment, high level of symptom burden and severe functional impairments in terms of hearing, vision and speech. We conducted standardised personal interviews. Additionally, clinical data were extracted from patient records.Primary and secondary outcome measuresOur target variable was subjectively perceived treatment urgency. Predictor variables included age, sex, education, health-related quality of life (EuroQol Five-Dimension Scale, value set UK), anxiety and depression (Hospital Anxiety and Depression Scale), somatic symptoms (Patient Health Questionnaire, 15 items version), self-reported health literacy (European Health Literacy Questionnaire, 16 questions version) and the commitment to the GP (Fragebogen zur Intensität der Hausarztbindung, ‘F-HaBi’). Data were analysed by multilevel, multivariable linear regression adjusted for random effects at the hospital level.ResultsOur sample comprised 276 patients with a mean age of 50.1 years and 51.8% women. A low treatment urgency (defined as 0–5 points on a Numerical Rating Scale) was reported by 111 patients (40.2%). In the final model, lower subjective treatment urgency was associated with male sex (β=0.84; 95% CI 0.11/1.57, p=0.024), higher health-related quality of life (−2.27 to –3.39/−1.15, pConclusionsA lower level of subjectively perceived treatment urgency was predicted by a lower willingness to use the GP as coordinator of treatment. Self-reported health literacy did not predict the patients’ urgency rating.

Purpose To investigate the association between health-related quality of life and ego integrity among the oldest old. Materials and methods Cross-sectional data were taken from follow-up wave 9 of the multicenter prospective cohort study “Needs, health service use, costs and health-related quality of life in a large sample of oldest-old primary care patients (85+)” (AgeQualiDe). Our analytical sample comprised n = 495 observations. Mean age was 90.2 years (SD: 2.7 years). Health-related quality of life was quantified using the EQ-5D-3L questionnaire (including the visual analogue scale EQ-VAS). Ego integrity was measured using the Ego Integrity Scale. Results Regressions showed an association between decreased ego integrity and problems with ‘usual activities’, ‘pain/discomfort’ and ‘anxiety/depression’. Furthermore, regressions showed a marginally significant association between decreased ego integrity and problems with ‘mobility’ and a decreased EQ-VAS score. Ego integrity was not significantly associated with problems with ‘self-care’. Conclusions Findings stress the importance of health-related quality of life for ego integrity among the oldest old. Future studies are required to clarify the underlying mechanisms.

To determine the prevalence of overweight and obesity, and to identify factors associated with obesity, among the oldest old.For this study, data from follow-up (FU) wave 7 and FU wave 8 of the 'Study on Needs, Health Service Use, Costs and Health-Related Quality of Life in a Large Sample of Oldest-Old Primary Care Patients (85+)' (AgeQualiDe) were used. At FU wave 7, the mean age was 88.9 years (SD: 2.9; 85-100 years). Body-mass-index (BMI) categories were defined according to the World Health Organization (WHO) thresholds: underweight (BMI < 18.5 kg/m²), normal weight (18.5 kg/m² ≤ BMI < 25 kg/m²), overweight (25 kg/m² ≤ BMI < 30 kg/m²), and obesity (BMI ≥ 30 kg/m²). Longitudinal regression analysis was used to determine factors associated with obesity.At FU wave 7, 3.0 % were underweight, 48.9 % were normal weight, 37.9 % were overweight, and 10.2 % were obese. Regressions showed that the probability of obesity decreased with age (OR: 0.77 [95 % CI: .593-.999]) and less chronic conditions (OR: 1.32 [95 % CI: 1.11-1.57]). The probability of obesity was not associated with sex, educational level, marital status, social isolation, visual impairment, hearing impairment, depression, and dementia.Nearly half of the individuals in very late life had excess weight. Thus, excess weight remains a major challenge, even in very old age. Given the demographic ageing in upcoming decades, this is an issue which we should be aware of.

The number of patients in emergency rooms without a medical emergency is increasing. Outpatient services for mutual support and relief between the in-patient and out-patient sector are not yet fully established.The aim was to determine the extent to which patients in emergency rooms have real medical emergencies by comparing patients with at least two and those with a maximum of one chronic illness. An additional aim was to identify factors influencing the previous use of outpatient structures.The study participants included emergency room patients from the cross-sectional study "PiNo-Nord." All persons in five emergency rooms in northern Germany between October 2015 and July 2016 who were not treated as "immediate" or "very urgent" were interviewed. An exploratory data analysis and multivariate logistic regression were performed.The 293 patients with ≥2 chronic diseases were just as often a medical emergency compared to the 847 patients with a maximum of 1 chronic disease. The most frequent occasions for consultation were musculoskeletal trauma (33%, n = 293 vs. 42%, n = 847) or trauma of the skin (11%, n = 293 vs. 13%, n = 847). In both groups, the general practitioner or specialist caregiver, as well as diagnostic or treatment options, rarely played a role in visiting the emergency department. The strongest predictors of previous outpatient treatment were the duration of the appeal in the last six months, a high subjective treatment urgency, the presence of at least two chronic conditions, and a consultation event concerning the musculoskeletal injuries.In both patient groups, no evidence of unnecessary visits to the emergency room was found. For the most part, outpatient structures are used in advance and the emergency department is only visited in the event of an actual medical emergency.

ObjectivesThe aim of our study was to explore patient types in general practitioner (GP) practices and to quantify the regional differences of the frequencies of these patient types in northern Germany.Design and settingWe conducted a mixed-methods study based on focus groups and standardised interviews with GPs. All counties and independent cities within a radius of 120 km around Hamburg were assigned one of three regional categories (urban areas, environs, rural areas). The focus groups were analysed using qualitative content analysis. Relative frequencies of consultations by patient types and differences between the regions were calculated. Logistic regression analyses were used to identify differences among regions.ParticipantsNine focus groups with 65 GPs (67.7% male). From the 280 initially recruited GPs 211 (65.4% male) could be personally interviewed.ResultsFour themes with 27 patient types were derived from the focus groups: patients classified by morbidity, sociodemographic characteristics, special care needs and patient behaviour. Five patient characteristics were significantly more prevalent in urban areas than rural areas: patients with migration background and culturally different disease concepts (OR 1.23; 95% CI 1.06 to 1.42), privately insured patients (OR 1.17; 95% CI 1.05 to 1.31), educationally disadvantaged patients with low health literacy (OR 1.11; 95% CI 1.04 to 1.19), patients with psychiatric disorders (OR 1.07; 95% CI 1.02 to 1.12) and senior citizens living on their own without caregivers (OR 1.05; 95% CI 1.05 to 1.31). Three patient types were significantly less prevalent in urban areas: minors accompanied by their parents (OR 0.71; 95% CI 0.61 to 0.83), patients with poor therapy adherence (OR 0.87, 95% CI 0.80 to 0.95) and patients with dementia (OR 0.90; 95% CI 0.82 to 0.99).ConclusionsGPs could compensate the specific needs of their patients with medical training aligned with the requirements of their region. Urban GPs need skills treating patients with psychiatric, social and cultural problems, rural GPs regarding the care for children or noncompliant patients.Trial registration numberNCT02558322

Objective The purpose of this study was to examine the impact of falls on depressive symptoms among the oldest old in Germany longitudinally. Methods Data were used from 2 waves of the multicenter prospective cohort "Study on needs, health service use, costs and health-related quality of life in a large sample of oldest-old primary care patients (85+)" (AgeQualiDe). This study covers primary care patients ≥85 years (at baseline: n = 547, average age of 88.9 ± 3.0 years; ranging from 85 to 100 years). General practitioner-diagnosed falls were used as explanatory variable. The Geriatric Depression Scale was used as outcome measure. Results Linear fixed effects regressions showed that the occurrence of falls is associated with an increase in depressive symptoms (β = .60, P = .02), whereas changes in marital status, ageing, social support, functional decline (instrumental activity of daily living), cognitive impairment, and an increase in chronic diseases did not affect depressive symptoms. In sensitivity analysis, an increase in depressive symptoms was associated with functional impairment (basic activities of daily living; Barthel index; β = -.04, P = .005). Conclusions Based on a large, population-based longitudinal study, this study underlined the impact of falls on depressive symptoms and consequently extended previous knowledge about an association between falls and depressive symptoms in the oldest old. Developing strategies to prevent falls might also help to prevent depressive symptoms.

To investigate how visual impairment affects social ties in late life longitudinally. Population-based prospective cohort study. Individuals in old age were recruited via general practitioners’ offices (at six study centers) in Germany. They were interviewed every 18 months. Individuals aged 75 years and above at baseline. Follow-up wave 2 (36 months after baseline, n=2,443) and wave 4 (72 months after baseline, n=1,618) were used for the analyses presented here. Social ties were assessed using the 14-item form of the questionnaire for social support (F-SozU K-14). Visual impairment was self-rated on a three level Likert scale (no impairment, mild visual impairment, or severe/profound visual impairment). Adjusting for sociodemographic factors, hearing impairment and comorbidity, fixed effects regressions revealed that the onset of mild visual impairment decreased the social support score, in particular the emotional support score. Additionally, the onset of mild hearing impairment decreased the social support score in men. Moreover, increasing age decreased the social support score in the total sample and in both sexes. Loss of spouse and increasing comorbidity did not affect the social support score. Our results highlight the importance of visual impairment for social ties in late life. Consequently, appropriate strategies in order to delay visual impairment might help to maintain social ties in old age.

Background:Most of the previous studies attempted to disentangle the relationship between disability and depressive symptoms were limited to observation periods of only few years. Moreover, evidence is missing regarding the complex co-occurrence of disability and depressive symptoms in old age in Germany. In order to close the research gap, we aimed at disentangling the complex co-occurrence of disability and depressive symptoms in old age in Germany over a longer time frame.Methods:Based on data from a representative survey of the German general population aged 75 years and older, the course of disability as well as depressive symptoms was observed every 1.5 years over six waves. While disability was quantified by the Lawton and Brody Instrumental Activities of Daily Living scale, the Geriatric Depression Scale was used to measure depressive symptoms. Taking into account the complex co-occurrence of depressive symptoms and disability, a panel vector autoregressive model was used. By taking the first differences, unobserved heterogeneity was taken into account.Results:In the total sample and in both sexes, we revealed a robust positive association between an initial change in depressive symptoms and subsequent changes in disability. No robust association between an initial change in disability and a subsequent change in depressive symptoms was detected.Conclusion:Our findings highlight the importance of changes in depressive symptoms for future changes in disability in old age.

Background: In the future, an increase in health care needs in the elderly is expected. Reports on unmet care needs of the oldest old with cognitive disorders are pending. This study aims at exploring unmet needs in the oldest old primary care patients with mild cognitive impairment (MCI) and dementia. Furthermore, the association between sociodemographic and clinical factors and unmet needs ought to be analyzed. Methods: Based on the study “Needs, Health Service Use, Costs and Health-Related Quality of Life in a Large Sample of Oldest-Old Primary Care Patients (85+)” (AgeQualiDe), 749 patients (unimpaired, MCI, and dementia) aged 85 years and older, their relatives (n = 421), and general practitioners (GPs) (n = 607) were assessed. Descriptive, inferential, and regression analyses were run. Results: Most unmet needs were observed in dementia patients, although needs were less frequently rated as unmet by dementia patients themselves as compared to relatives and GPs. Unmet needs were associated with MCI and dementia; other risk factors were age, education, and marital status. Conclusion: This study provides first data on unmet needs according to different perceptions in the elderly with MCI and dementia in Germany. Need assessments should be part of medical examinations to ensure a high-quality health care in the elderly.

Introduction Inappropriate supply and an increasing demand on the healthcare system have been of concern for health policy in Germany for at least 15 years. In the primary care setting, this especially relates to an undersupply of general practitioners (GPs) in the countryside. In addition, there seem to be other regional differences, for example, a difference in accessing primary and secondary care between rural and urban areas. Despite these findings, regional differences in health services have not been studied extensively in Germany. Therefore, this study aims to explore regional variations of patient populations and reasons for accessing primary medical care. Methods and analysis We will conduct a cross-sectional observational study based on standardised interviews with 240 GPs and ∼1200 patients. Data collection started on 10 June 2015 and will probably be completed by 31 October 2016. We will include all districts and cities within 100 km from Hamburg and assign them according to the type of regions: rural, urban and environs. All eligible GPs will be invited to participate. Each practice will recruit up to 15 patients, aged 18 years or older. Questionnaires are based on a preliminary qualitative study and were pretested. Data will be analysed with descriptive statistics and regression modelling strategies adjusted for confounders and the GP-induced cluster structure. Ethics and dissemination Our study was approved by the Ethics Committee of the Medical Association of Hamburg and is conducted in accordance with the Declaration of Helsinki. Study participants give written informed consent before data collection and data is pseudonymised. Survey data and person identifiers are stored separately in locked cabinets and have restricted availability. The results of our study will be presented at conferences and published in peer-reviewed journals. Trial registration number NCT02558322; Pre-results.

Objective The study aimed to develop a comprehensive algorithm (meta-algorithm) for primary care encounters of patients with multimorbidity. We used a novel, case-based and evidence-based procedure to overcome methodological difficulties in guideline development for patients with complex care needs. Study design Systematic guideline development methodology including systematic evidence retrieval (guideline synopses), expert opinions and informal and formal consensus procedures. Setting Primary care. Intervention The meta-algorithm was developed in six steps:1. Designing 10 case vignettes of patients with multimorbidity (common, epidemiologically confirmed disease patterns and/or particularly challenging health care needs) in a multidisciplinary workshop.2. Based on the main diagnoses, a systematic guideline synopsis of evidence-based and consensus-based clinical practice guidelines was prepared. The recommendations were prioritised according to the clinical and psychosocial characteristics of the case vignettes.3. Case vignettes along with the respective guideline recommendations were validated and specifically commented on by an external panel of practicing general practitioners (GPs).4. Guideline recommendations and experts’ opinions were summarised as case specific management recommendations (N-of-one guidelines).5. Healthcare preferences of patients with multimorbidity were elicited from a systematic literature review and supplemented with information from qualitative interviews.6. All N-of-one guidelines were analysed using pattern recognition to identify common decision nodes and care elements. These elements were put together to form a generic meta-algorithm. Results The resulting meta-algorithm reflects the logic of a GP9s encounter of a patient with multimorbidity regarding decision-making situations, communication needs and priorities. It can be filled with the complex problems of individual patients and hereby offer guidance to the practitioner. Contrary to simple, symptom-oriented algorithms, the meta-algorithm illustrates a superordinate process that permanently keeps the entire patient in view. Conclusion The meta-algorithm represents the back bone of the multimorbidity guideline of the German College of General Practitioners and Family Physicians. This article presents solely the development phase; the meta-algorithm needs to be piloted before it can be implemented.

A survey conducted in 2011/12 on evidence-based medicine teaching activities in Germany, Austria and Switzerland shows an apparent increase of undergraduate and postgraduate teaching activities addressing different target groups. The potential target-group specific or generalised nature of teaching activities in EbM were explored by comparing the contents and structures of educational offers in order to detect differences and commonalities.First, several large institutions of the healthcare system were contacted. In addition, the participants of the EbM Academy were consulted as key informants, and the members of the German-speaking colleges of general practitioners and the German Network for EBM were asked to identify potential providers of EbM teaching activities. In the second step pretested detailed questionnaires were sent out that allowed a target-group specific analysis of contents, structures and didactic methods.Altogether, 185 teaching activities in EbM are described; 117 (6.8%) of these address students, 70 (37.8%) physicians and 55 (29.7%) caregivers and members of other healthcare professions. Further target groups include people interested in the healthcare system with a total of 38 (i.e., 20.5%) and patients with 18 (9.7%) teaching activities (multiple responses allowed). Students are mainly taught in obligatory seminars, courses or lectures with a high number of participants, whereas teaching activities addressing other target groups are mostly offered to small groups of participants in the form of optional seminars, courses or workshops lasting a similar length of time. As regards the content, attendees from all target groups with only little previous knowledge are taught the first three steps of EbM according to Sackett. Specialised contents are not distributed evenly and reveal some adaptation to the respective target groups.Structural differences between the target groups are most likely attributed to distinct framework conditions in education and career. Parallels in content demonstrate high rates of conformity concerning the teaching of basic knowledge, though, while individually selecting particular focus areas of special expertise.

In the last 15 years Evidence-based Medicine (EbM) has gained much publicity in the German-speaking countries, but it is currently difficult to conclude how much the contents of EbM with its five steps according to Sackett have spread. Data from the year 2006 show that less than half of all medical faculties in Germany have introduced EbM into undergraduate teaching and that there is a shortage in EbM teaching activities for graduates in the German-speaking countries as well. The goal of this survey is to display the undergraduate and graduate Evidence-based Practice teaching activities in the German-speaking countries.In a two-step survey, we first sent out a total of 551 letters to medical faculties, colleges, boards of physicians, the German Hospital Association, the associations of statutory health insurance physicians in Germany, the Medical Service of the German health insurances and asked the 30 participants of the 2011 EbM Academy as key informants in writing to give details about potential providers of EbM teaching activities. Via email we also consulted the members of the German-speaking colleges of general practitioners and family medicine and the German Network for EBM, course participants and contact persons of familiar teaching activities. In a second step a pre-tested detailed questionnaire with 36 items in the five categories framework and structure, participant characterisation, contents and didactics, evaluation and publication, and planning and publicity was sent to potential providers.Altogether 185 teaching activities were identified, 80 % of which were located in Germany, 13 % in Austria and 7 % in Switzerland. In 82.6 % of the cases it was either a seminar, a course or a workshop with a median of 20 participants and an average duration of 17.9hours. The teaching activities mainly addressed students (63.2 %), physicians (37.8 %), caregivers and members of other health care professions with little or no prior knowledge of EbM. The first three steps of EbM (formulating clinical questions, search for and appraisal of the literature) were taught in more than 75 % of the teaching activities, whereas steps four and five (integration of results, evaluation) were only taught in 53.9 % and 33.3 % of the cases, respectively.Compared to 2006, a remarkable increase in EbM teaching activities was observed in the German-speaking areas. These activities address different target audiences; the main content focus is on the first steps of EbM.

Disease Management Programmes (DMPs) are structured treatment programmes for chronic diseases. The DMP requirements are primarily derived from evidence-based guidelines. DMPs are regularly revised to ensure that they reflect current best practice and medical knowledge. The aim of this study was to assess the need for updating the German DMP module on heart failure by comparing it to relevant guidelines and identifying recommendations that should be revised.We systematically searched for clinical guidelines on heart failure published in German, English or French, and extracted relevant guideline recommendations. All included guidelines were assessed for methodological quality. To identify revision needs in the DMP, we performed a synoptic analysis of the extracted guideline recommendations and DMP requirements.27 guidelines were included. The extracted recommendations covered all aspects of the management of heart failure. The comparison of guideline recommendations with DMP requirements showed that, overall, guideline recommendations were more detailed than DMP requirements, and that the guidelines covered topics not included in the DMP module.The DMP module is largely consistent with current guidelines on heart failure. We did not identify any need for significant revision of the DMP requirements. However, some specific recommendations of the DMP module could benefit from revision.

Background An ageing population, a growing prevalence of chronic diseases and limited financial resources for health care underpin the importance of prevention of disabling health disorders and care dependency in the elderly. A wide variety of measures is generally available for the prevention of falls and fall-related injuries. The spectrum ranges from diagnostic procedures for identifying individuals at risk of falling to complex interventions for the removal or reduction of identified risk factors. However, the clinical and economic effectiveness of the majority of recommended strategies for fall prevention is unclear. Against this background, the literature analyses in this HTA report aim to support decision-making for effective and efficient fall prevention. Research questions The pivotal research question addresses the effectiveness of single interventions and complex programmes for the prevention of falls and fall-related injuries. The target population are the elderly (> 60 years), living in their own housing or in long term care facilities. Further research questions refer to the cost-effectiveness of fall prevention measures, and their ethical, social and legal implications. Methods Systematic literature searches were performed in 31 databases covering the publication period from January 2003 to January 2010. While the effectiveness of interventions is solely assessed on the basis of randomised controlled trials (RCT), the assessment of the effectiveness of diagnostic procedures also considers prospective accuracy studies. In order to clarify social, ethical and legal aspects all studies deemed relevant with regard to content were taken into consideration, irrespective of their study design. Study selection and critical appraisal were conducted by two independent assessors. Due to clinical heterogeneity of the studies no meta-analyses were performed. Results Out of 12,000 references retrieved by literature searches, 184 meet the inclusion criteria. However, to a variable degree the validity of their results must be rated as compromised due to different biasing factors. In summary, it appears that the performance of tests or the application of parameters to identify individuals at risk of falling yields little or no clinically relevant information. Positive effects of exercise interventions may be expected in relatively young and healthy seniors, while studies indicate opposite effects in the fragile elderly. For this specific vulnerable population the modification of the housing environment shows protective effects. A low number of studies, low quality of studies or inconsistent results lead to the conclusion that the effectiveness of the following interventions has to be rated unclear yet: correction of vision disorders, modification of psychotropic medication, vitamin D supplementation, nutritional supplements, psychological interventions, education of nursing personnel, multiple and multifactorial programs as well as the application of hip protectors. For the context of the German health care system the economic evaluations of fall prevention retrieved by the literature searches yield very few useful results. Cost-effectiveness calculations of fall prevention are mostly based on weak effectiveness data as well as on epidemiological and cost data from foreign health care systems. Ethical analysis demonstrates ambivalent views of the target population concerning fall risk and the necessity of fall prevention. The willingness to take up preventive measures depends on a variety of personal factors, the quality of information, guidance and decision-making, the prevention program itself and social support. The analysis of papers regarding legal issues shows three main challenges: the uncertainty of which standard of care has to be expected with regard to fall prevention, the necessity to consider the specific conditions of every single case when measures for fall prevention are applied, and the difficulty to balance the rights to autonomous decision making and physical integrity. Discussion and conclusions The assessment of clinical effectiveness of interventions for fall prevention is complicated by inherent methodological problems (esp. absence of blinding) and meaningful clinical heterogeneity of available studies. Therefore meta-analyses are not appropriate, and single study results are difficult to interpret. Both problems also impair the informative value of economic analyses. With this background it has to be stated that current recommendations regarding fall prevention in the elderly are not fully supported by scientific evidence. In particular, for the generation of new recommendations the dependency of probable effects on specific characteristics of the target populations or care settings should be taken into consideration. This also applies to the variable factors influencing the willingness of the target population to take up and pursue preventive measures. In the planning of future studies equal weight should be placed on methodological rigour (freedom from biases) and transferability of results into routine care. Economic analyses require input of German data, either in form of a “piggy back study“ or in form of a modelling study that reflects the structures of the German health care system and is based on German epidemiological and cost data., GMS Health Technology Assessment; 8:Doc01; ISSN 1861-8863

For decades various pressure ulcer risk assessment scales (PURAS) have been developed and implemented into nursing practice despite uncertainty whether use of these tools helps to prevent pressure ulcers. According to current methodological standards, randomised controlled trials (RCTs) are required to conclusively determine the clinical efficacy and safety of this risk assessment strategy. In these trials, PURAS-aided risk assessment has to be compared to nurses' clinical judgment alone in terms of its impact on pressure ulcer incidence and adverse outcomes. However, RCTs evaluating diagnostic procedures are prone to specific risks of bias and threats to the statistical power which may challenge their validity and feasibility. This discussion paper critically reflects on the rigour and feasibility of experimental research needed to substantiate the clinical efficacy of PURAS-aided risk assessment. Based on reflections of the methodological literature, a critical appraisal of available trials on this subject and an analysis of a protocol developed for a methodologically robust cluster-RCT, this paper arrives at the following conclusions: First, available trials do not provide reliable estimates of the impact of PURAS-aided risk assessment on pressure ulcer incidence compared to nurses' clinical judgement alone due to serious risks of bias and insufficient sample size. Second, it seems infeasible to assess this impact by means of rigorous experimental studies since sample size would become extremely high if likely threats to validity and power are properly taken into account. Third, means of evidence linkages seem to currently be the most promising approaches for evaluating the clinical efficacy and safety of PURAS-aided risk assessment. With this kind of secondary research, the downstream effect of use of PURAS on pressure ulcer incidence could be modelled by combining best available evidence for single parts of this pathway. However, to yield reliable modelling results, more robust experimental research evaluating specific parts of the pressure ulcer risk assessment-prevention pathway is needed.

In December 2010, the Institutes for Social Medicine and Cancer Epidemiology of the University of Lübeck hosted the first Workshop for Early Career Investigators in the area of Health Services Research. This workshop was funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) with the aim to promote young scientists and researchers that wish to pursue research in the field of Health Services Research in an early phase of their career. The following report addresses the background, concept and progress of the initiative. All applicants had to submit a detailed project proposal and underwent a rigorous selection process. The projects presented at the workshop covered a wide range of topics, such as, for example, access to health care, common elements of mental illnesses and psychosomatic disorders, quality assurance in medical practices (i.e., evaluation of disease management programmes) and targets in rehabilitation. A major subject was migration as a challenge to Health Services Research. The 20 best applicants out of 121 were invited to attend the programme. During five days the participants had the opportunity to present their projects and discuss current issues as well as fundamental themes in study design. At the same time, national and international leading experts gave a series of lectures on current topics of Health Services Research. In numerous discussion groups and topical workshops participants and speakers explored and sought solutions to specific research issues. Following the programme participants are expected to finalise their research proposals and apply for funding to the DFG. To foster networking among early-career researchers, an alumni meeting is scheduled after 12 months. The DFG Workshop for Early Career Investigators was the first of its kind in the field of Health Services Research in Germany. However, evidence of its sustainability will have to be obtained from the future development of the German Health Services Research.

Health technology assessment (HTA) is the multidisciplinary study of the implications of the development, diffusion and use of health technologies. It supports health-policy decisions by providing a joint knowledge base for decision-makers. To increase its policy relevance, HTA tries to extend beyond effectiveness and costs to also considering the social, organizational and ethical implications of technologies. However, a commonly accepted method for analysing the ethical aspects of health technologies is lacking. This paper describes a model for ethical analysis of health technology that is easy and flexible to use in different organizational settings and cultures. The model is part of the EUnetHTA project, which focuses on the transferability of HTAs between countries. The EUnetHTA ethics model is based on the insight that the whole HTA process is value laden. It is not sufficient to only analyse the ethical consequences of a technology, but also the ethical issues of the whole HTA process must be considered. Selection of assessment topics, methods and outcomes is essentially a value-laden decision. Health technologies may challenge moral or cultural values and beliefs, and their implementation may also have significant impact on people other than the patient. These are essential considerations for health policy. The ethics model is structured around key ethical questions rather than philosophical theories, to be applicable to different cultures and usable by non-philosophers. Integrating ethical considerations into HTA can improve the relevance of technology assessments for health care and health policy in both developed and developing countries.

Objective We aimed to evaluate and compare the efficacy of the bicaval and the biatrial standard techniques in orthotopic heart transplantation. Methods A systematic review with meta-analysis was performed. As data sources, we used the electronic databases EMBASE and Medline (1966–August 2006), hand searching in 4 journals, expert consultation, and reference lists of reviews. Observational and randomized and prospective and retrospective controlled trials that reported outcomes on the 2 techniques of heart transplantation were considered. Results A total of 23 retrospective and 18 prospective studies were included. Meta-analyses of prospective trials including between 228 and 472 patients revealed significant superiority of the bicaval technique in comparison with the biatrial procedure for early atrial pressure (weighted mean difference, −3.95; 95% confidence interval, −6.50 to −1.40), perioperative mortality (odds ratio, 0.41; 95% confidence interval, 0.17 to 0.98), tricuspid valve regurgitation (odds ratio, 0.23; 95% confidence interval, 0.15 to 0.36), and sinus rhythm (odds ratio, 7.01; 95% confidence interval, 2.57 to 19.13). The latter also showed a significant difference in the analysis of retrospective studies (odds ratio, 2.69; 95% confidence interval, 1.55 to 4.66). Conclusion In summary, this systematic review and meta-analysis provides evidence of clinically relevant beneficial effects of the bicaval technique in comparison with those of the standard technique. Nevertheless, the longer-term beneficial effects of the bicaval technique remain to be evaluated.

Information derived from Health Technology Assessment (HTA) reports is increasingly used for decision-making in healthcare. The production of HTA reports requires well-qualified interdisciplinarily working specialists who are not yet available in sufficient number. The German HTA Society and the German Network for Evidence Based Medicine have now developed an HTA curriculum which may serve as a basis for training courses for users of HTA information as well as HTA authors. Structure and content of the curriculum were inspired by internationally established training courses. However, the specific aspects of technology regulation and decision-making in the healthcare systems of German-speaking countries are emphasised. The curriculum is subdivided into a total of 11 modules. These include principles of HTA, status and regulation of technologies, priority setting, management of knowledge and information, methods of conducting HTA reports and project management. In the next step, the application of the curriculum into an Internet-based training course is planned.

Evidence-based medicine is not self-explaining. But due to the use of methodological, technical and statistical terms beginners might find it difficult to get access to EbM. To overcome this hurdle, a working group of practising physicians and methodologists have developed a glossary for the German Network Evidence-based Medicine covering the most important terms and providing explanations by giving practical examples. Access is also possible through www.ebm-netzwerk.de/glossar.htm. The present glossary is just a start, though. Over the coming years more terms will have to be added according to the needs and suggestions of our readership. We thus call on active participation of its users.

In 2002 the German "Curriculum Evidence-based Medicine" was made available by the Agency for Quality in Medicine and the German Network for Evidence-based Medicine. Its primary aim was to train practising medical doctors. We adapted the curriculum for participants of a postgraduate Master of Public Health course and a course for medical students. The two groups differ from the main target group regarding both their baseline knowledge and the objectives of their respective training courses. Here we report how the curriculum was adapted. The curriculum was adjusted in several ways: The postgraduate course focused on case studies with public health relevance. Beyond the obligatory modules, the focus was on training skills in searching and assessing secondary and tertiary evidence like systematic reviews or health technology assessments. In addition, the health policy context for evidence based medicine in Germany was analysed. In the course that aimed at medical students we included the module "Critical Appraisal of a Survey". At the beginning of each case study, the frequency and relevance of the health problems were elaborated. Apart from case studies on therapeutic interventions we also presented studies on diagnosis, prognosis and screening to demonstrate that evidence-based clinical decision making is feasible for the whole spectrum of questions arising from patient care. The curriculum proved to be adaptive to the needs of heterogeneous groups of participants. In this article we provide a detailed list of practical recommendations for courses for students of Public Health and Medicine.