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Background: Patients from rural and urban regions should have equitable access to health care. In Germany, the physician-patient-ratio and the supply of medical services vary greatly between urban and rural areas. The aim of our study was to explore the regional variations of the perceived health care problems in ambulatory care from the perspective of affected professionals and laypersons i.e. general practitioners and their patients. Methods: We conducted 27 focus groups with general practitioners (n = 65) and patients (n = 145) from urban areas, environs and rural areas in northern Germany. Discussions were facilitated by two researchers using a semi-structured guideline. The transcripts were content analyzed using deductive and inductive categories. Results: General practitioners and patients reported problems due to demographic change and patient behaviour, through structural inequalities and the ambulatory reimbursement system as well as with specialist care and inpatient care. A high physician density, associated with high competition between general practitioners, a high fluctuation of patients and a low status of general practitioners were the main problems reported in urban areas. In contrast, participants from rural areas reported an insufficient physician density, a lack of young recruits in primary care and a resulting increased workload as problematic. All regions are concerned with subjectively inadequate general practitioners' budgets, insufficiently compensated consultations and problems in the cooperation with specialists and inpatient care institutions. Most problems were mentioned by GPs and patients alike, but some (e.g. high competition rates in urban regions and problems with inpatient care) were only mentioned by GPs. Conclusions: While many problems arise in urban regions as well as in rural regions, our results support the notion that there is an urgent need for action in rural areas. Possible measures include the support of telemedicine, delegation of medical services and reoccupation of vacant practices. The attractiveness of working in rural areas for general practitioners, specialists and clinicians must be increased by consolidating and expanding rural infrastructure (e.g. child care and cultural life). The above mentioned results also indicate that the ambulatory reimbursement system should be examined regarding the reported inequalities. Measures to further enhance the cooperation between general practitioners, specialists and inpatient care should be taken to solve supra-regionally reported problems. Problems showing regional variations indicate the need for measures to balance these variations between the regions. This is the first German study to analyze subjective views of the stakeholders concerned on regionally variating problems in ambulatory care. Further studies are needed to quantify the extent of the identified problems and differences. A corresponding survey is currently under way. [ABSTRACT FROM AUTHOR]

BACKGROUND: To date, evidence-based recommendations help doctors to manage patients with heart failure (HF). However, the implementation of these recommendations in primary care is still problematic as beneficial drugs are infrequently prescribed. The aim of the study was to determine whether admission to hospital increases usage of beneficial HF medication and if this usage is maintained directly after discharge. METHODS: The study was conducted from November 2002 until January 2004. In 77 patients hospitalised with heart failure (HF), the medication prescribed by the referring general practitioner (GP) and drug treatment directed by the hospital physicians was documented. Information regarding the post-discharge (14 d) therapy by the GP was evaluated via a telephone interview. Ejection fraction values, comorbidity and specifics regarding diagnostic or therapeutic intervention were collected by chart review. RESULTS: When compared to the referring GPs, hospital physicians prescribed more ACE-inhibitors (58.4% vs. 76.6%; p = 0.001) and beta-blockers of proven efficacy in HF (metoprolol, bisoprolol, carvedilol; 58.4% vs. 81.8%). Aldosterone antagonists were also administered more frequently in the hospital setting compared to general practice (14.3% vs. 37.7%). The New York Heart Association classification for heart failure did not influence whether aldosterone antagonists were administered either in primary or secondary care. Fourteen days after discharge, there was no significant discontinuity in discharge medication. CONCLUSION: Patients suffering from HF were more likely to receive beneficial medication in hospital than prior to admission. The treatment regime then remained stable two weeks after discharge. We suggest that findings on drug continuation in different cardiovascular patients might be considered validated for patients with HF. [ABSTRACT FROM AUTHOR]

BACKGROUND: Screening of primary care patients at risk for left ventricular systolic dysfunction by a simple blood-test might reduce referral rates for echocardiography. Whether or not natriuretic peptide testing is a useful and cost-effective diagnostic instrument in primary care settings, however, is still a matter of debate. METHODS: N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, clinical information, and echocardiographic data of left ventricular systolic function were collected in 542 family practice patients with at least one cardiovascular risk factor. We determined the diagnostic power of the NT-proBNP assessment in ruling out left ventricular systolic dysfunction and compared it to a risk score derived from a logistic regression model of easily acquired clinical information. RESULTS: 23 of 542 patients showed left ventricular systolic dysfunction. Both NT-proBNP and the clinical risk score consisting of dyspnea at exertion and ankle swelling, coronary artery disease and diuretic treatment showed excellent diagnostic power for ruling out left ventricular systolic dysfunction. AUC of NT-proBNP was 0.83 (95% CI, 0.75 to 0.92) with a sensitivity of 0.91 (95% CI, 0.71 to 0.98) and a specificity of 0.46 (95% CI, 0.41 to 0.50). AUC of the clinical risk score was 0.85 (95% CI, 0.79 to 0.91) with a sensitivity of 0.91 (95% CI, 0.71 to 0.98) and a specificity of 0.64 (95% CI, 0.59 to 0.67). 148 misclassifications using NT-proBNP and 55 using the clinical risk score revealed a significant difference (McNemar test; p < 0.001) that was based on the higher specificity of the clinical risk score. CONCLUSION: The evaluation of clinical information is at least as effective as NT-proBNP testing in ruling out left ventricular systolic dysfunction in family practice patients at risk. If these results are confirmed in larger cohorts and in different samples, family physicians should be encouraged to rely on the diagnostic power of the clinical information from their patients. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization (WHO) has established a set of items related to study design and administrative information that should build the minimum set of data in a study register. A more comprehensive data set for registration is currently developed by the Ottawa Group. Since nothing is known about the attitudes of academic researchers towards prospective study registration, we surveyed academic researchers about their opinion regarding the registration of study details proposed by the WHO and the Ottawa Group.Methods: This was a web-based survey of academic researchers currently running an investigator-initiated clinical study which is registered with clinicaltrials.gov. In July 2006 we contacted 1299 principal investigators of clinical studies by e-mail explaining the purpose of the survey and a link to access a 52-item questionnaire based on the proposed minimum data set by the Ottawa Group. Two reminder e-mails were sent each two weeks apart. Association between willingness to disclose study details and study phase was assessed using the chi-squared test for trend. To explore the potential influence of non-response bias we used logistic regression to assess associations between factors associated with non-response and the willingness to register study details.Results: Overall response was low as only 282/1299 (22%) principal investigators participated in the survey. Disclosing study documents, in particular the study protocol and financial agreements, was found to be most problematic with only 31% of respondents willing to disclose these publicly. Consequently, only 34/282 (12%) agreed to disclose all details proposed by the Ottawa Group. Logistic regression indicated no association between characteristics of non-responders and willingness to disclose details.Conclusion: Principal investigators of non-industry sponsored studies are reluctant to disclose all data items proposed by the Ottawa Group. Disclosing the study protocol and financial agreements was found to be most problematic. Future discussions on trial registration should not only focus on industry but also on academic researchers. [ABSTRACT FROM AUTHOR]

Background: Use of combustible cigarettes (CCs) and smokeless oral tobacco products are well documented risk factors for a variety of oral diseases. However, the potential oral health risks of using recently introduced (since about 2000) non-combustible tobacco/nicotine products (NCPs: electronic cigarettes (ECs), heated tobacco products (HTPs) and oral nicotine pouches (ONPs), remain poorly established., Methods: This review evaluates published human studies on detrimental oral health effects in people who use NCPs compared to those smoking cigarettes and those not using any tobacco/nicotine product (NU). We identified 52 studies, predominantly focusing on adults who used electronic cigarettes as an NCP. The studies exhibited significant heterogeneity regarding design, populations, endpoints and quality. Reported outcomes, based on both single and grouped endpoints were qualitatively evaluated by comparing people who use NCPs with NU and with people smoking CCs. Significant increases (indicating a worsening in oral health), significant decreases (indicating a lower level of detrimental effects) and no significant difference between groups were assigned scores of + 1, -1 and 0, respectively. Scores from studies belonging to the same single or grouped endpoints were averaged to a summary score ranging from - 1 to + 1., Results: The qualitative meta-analysis revealed that comparisons of EC versus NU groups yielded mean scores of 0.29 for pre-cancerous lesions (N = 14 observations), 0.27 for inflammatory processes (N = 83), 0.43 for oral clinical parameters (N = 93) and 0.70 for shifts in the oral microbiome (N = 10). The corresponding values for the EC versus CC group comparisons amounted to -0.33 (N = 15), -0.14 (N = 76), -0.27 (N = 78) and 0.57 (N = 7). Most studies had significant limitations regarding group sizes, duration of NCP use (mostly only a few years) and validity of self-reported exclusive NCP use. Notably, the implications of dual use (EC + CC) and prior CC use were often not adequately considered., Conclusions: The evaluated studies suggest that use of ECs is associated with relatively fewer detrimental oral health effects compared to smoking, yet oral health status remains poorer compared to not using any tobacco/nicotine products. These results have to be interpreted with caution due to a number of limitations and uncertainties in the underlying studies, particularly the potential biases and confounding factors inherent in cross-sectional study designs., Competing Interests: Declarations. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Background: Empathy plays an important role in the interaction and communication with patients. Physicians' empathy has various positive patients' and physicians' outcomes. Despite the inclusion of empathy in medical curricula and the relevance of empathy in general and physicians' concept of it to medical care, there is no common definition of empathy in the clinical context: definitions tend to be abstract and we do not know enough about medical students' conceptualization of clinical empathy. A clear and consensual definition of empathy is needed to be able to teach and measure empathy adequately. We aimed to explore German medical students' views and understanding of (clinical) empathy., Methods: We interviewed 24 students from the second half of the 3rd year and in their final clinical year (six female and male students in each subgroup) using a semi-structured interview guide. Interviews were digitally recorded and transcribed verbatim. We analysed the transcripts using thematic synthesis (Braun & Clarke)., Results: We found three overarching themes: (1) empathy means perceiving and understanding patients' needs and acting accordingly, (2) empathy as an interpersonal, intangible construct and (3) taking time for patients. Showing interests, impartiality and openness towards the patients as well as the need to take patients seriously, treating them with respect, having a holistic view on patients and generate some kind of closeness with patients are subthemes of the first overarching theme., Conclusions: Although it is often stated that the various existing definitions of empathy are abstract or far from practice, German medical students seem to have a good idea how to define empathy. Their definition resembles definitions known from the literature and used in education. Further research is needed to compare concepts of empathy of medical students from different countries and cultural backgrounds to inform research and teaching. It would also be interesting to investigate how concepts of empathy change over the course of study and affect perceptions of empathy in third party assessments., Competing Interests: Declarations. Ethics approval and consent to participate: No formal ethical approval process was performed after consulting the Ethics Committee of the Medical Association of Hamburg (no. PV5143). The study was conducted in accordance to the Declaration of Helsinki, including, but not limited to, the guaranteed anonymity of all participants and their informed consent. All students involved in the study took part voluntarily, gave their written informed consent and agreed to the publication of anonymous data. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests. Authors’ informations: NJP is a female trained psychologist and senior scientist with comprehensive experience in conducting focus groups and interviews as well as qualitative data analysis. AS holds a bachelor degree in physiotherapy and a master degree in health sciences, she is a female researcher with some experience in interviewing and qualitative data analysis. MS is a male full professor of Medicine and board certified in General Medicine., (© 2024. The Author(s).)

New types of nicotine and tobacco products like electronic cigarettes (ECs), heated tobacco products or nicotine pouches have been discussed as less harmful alternatives to combustible cigarettes and other toxic forms of tobacco products. Their harm reduction potential lay in the efficient transition away from smoking to those new products. Numerous studies addressing the cessation efficacy of ECs have been published with contradictory outcomes. Yet, a comprehensive Cochrane review concluded with high certainty on the cessation efficacy of ECs. This prompted us to perform a review to identify weaknesses in common study designs and to summarize best practices for the study design on the potential of new nicotine products as cessation aids. 120 articles retrieved from Medline were found to be eligible. Most of the studies in the field were interventional trials while observational studies played a minor role in the evaluation of smoking cessation. Efficacy was predominantly assessed for ECs in 77% of the reports while heated tobacco (17%) and non-combustible products (11%) were less frequently investigated up to now. Measures to determine the efficacy were questionnaire-based assessments as well as use documentation/prevalence and abstinence rates. Studies varied largely in their duration and sample size with medians of 3 months and 156.5 participants, respectively.With the help of this review, we identified several weaknesses in the common study designs. One major limitation in longitudinal trials was the lack of compliance measures suited to verify the use status over longer time periods, relying solely on self-reports. Moreover, the motivation of the participants to quit was rarely defined and a profound familiarization period was not taken into account for the majority of the studies. To what extent such weaknesses influence the outcome of the studies was beyond the scope of this review. We encourage researchers to consider the recommendations which resulted from this review in order to determine the abuse liability and cessation efficacy of the products in a more robust manner. Finally, we like to call attention to the missing data for low- and middle-income countries which would require quitting strategies most urgently to combat the tobacco smoking epidemic., (© 2024. The Author(s).)

Background: Older people receiving home-based care (HBC) often face barriers to access preventive oral health care (OHC) and dental treatments. Leading to deterioration of their oral healthcare. It is further deteriorated by factors such as increasing burden of systemic diseases, medicinal side effects, limited mobility, financial constraints and lack of professional OHC at home. Older people also struggle to maintain necessary daily oral hygiene, leading to malnutrition, weight loss, and a risk of a further health degradation. This cross-sectional survey aimed to investigate the oral health-related quality of life (OHRQoL) and their associated factors in HBC recipients., Methods: 5,280 older people (≥ 60 years) living in Hamburg, who were in need of care and insured with statutory health insurance DAK-Gesundheit received the questionnaire, which included the German version of the Oral Health Impact Profile (OHIP G-14) and, the EQ-5D health-related quality of life (HRQoL) measure as well as further questions regarding the extent of informal social support, subjective oral health status, oral health behaviour, subjective cognitive status, and socio-demographic variables., Results: The participants (n = 1,622) had a median age of 83.2 years, with 72.0% of the sample being female. Nearly two thirds of the sample reported that their independence or abilities were significantly impaired (care level 2). Regarding oral health impacts, 40.0% of the participants reported experiencing at least one of the fourteen possible prevalent impacts of the OHIP-G14 fairly often or very often. A multivariate regression model on the severity of oral health impacts revealed, that a better HRQoL, a positive perception of one's own dental status, fewer visits to dental practices, and no need for support in OHC were associated with better OHRQoL. Conversely, respondents with a negative perception of their oral health status, more frequent visits to a dental practice, a need for support in OHC, and subjective memory impairment showed poorer OHRQoL., Conclusions: The results highlight the risk for poor oral health among older people in HBC. We conclude that there is an urgent need to prioritise oral health, especially as poor oral health can further compromise the systemic wellbeing of these already care dependent population., (© 2024. The Author(s).)

Background: Immersive virtual reality (VR) is an innovative strategy for inpatient rehabilitation programs. Using immersive VR in early mobilization protocols has not yet been investigated in the setting of hospitalized patients with acute decompensated heart failure (ADHF), especially to improve perceived dyspnea, a common symptom of heart failure (HF)., Methods: This is a single-center parallel superiority randomized clinical trial. The study will be conducted at a public teaching hospital in Brazil from January 2023 to January 2024. The sample will include adult patients with ADHF hospitalized for at least 24 h, randomly assigned in a 1:1 ratio to the control (standard early mobilization protocol conducted in the intensive care unit (ICU)) or intervention group (the same standard early mobilization protocol but associated with immersive VR). The primary outcome will be assessing perceived dyspnea, and the secondary outcome will be assessing patient experience., Discussion: Using immersive VR in early mobilization protocols in the ICU is expected to improve perceived dyspnea in patients with ADHF as well as patient experience regarding care. This study has the potential to increase patient adherence to early mobilization protocols in the setting of ADHF as well as to promote a positive patient experience. Filling this gap could promote the rational incorporation of technologies in health care., Trial Registration: This study protocol is in its first version., Clinicaltrials: gov NCT05596292. Registered on 1 December 2022., (© 2023. The Author(s).)

Background: In Germany, homeless people are entitled to health care within the regular health care system. However, due to their specific living conditions they make little use of these services. In 2013, three Medical centres for the homeless (MCH) were opened in Hamburg to provide general health care. This study aims to analyse the consultation reasons and diagnoses prevalent among the homeless in comparison to regular primary care patients. It also examines the means and obstacles of integrating the homeless into Germany's regular health care system., Methods: From 2013 to 2014, routine medical data of all patients of the MCH consenting to participate in the study were analysed descriptively, in particular consultation reasons (categorised by ICPC-2), ICD-10 diagnoses and data on health insurance status and the use of the regular health care system. Consultation reasons and diagnoses of homeless patients were compared descriptively with data from regular general practices. Additionally, anonymous data on patient numbers, gender and insurance status was exported from the MCH's software and analysed descriptively for the years 2013 to 2020., Results: A total of 840 homeless patients in 2013 and 2014 gave consent to the evaluation of consultation reasons and diagnoses. The most frequent consultation reasons in the MCH in 2013 were skin conditions (24%), musculoskeletal conditions (16%) and psychological disorders (14%), in GP practices these were musculoskeletal conditions (22%), conditions affecting the digestive system (14%) and skin conditions (12%). Essential (primary) hypertension, diabetes mellitus type 2 and back pain are among the top-10-diagnoses in GP practices, as well as in MCH. With regard to the other top-10-diagnoses, there are clear differences between GP practices and MCH: "Psychological behavioural disorder due to alcohol" and diagnoses in connection with trauma, skin infections and acute respiratory infections stand out in MCH. 35% of the homeless patients reported a lack of health insurance as the reason for "not making use of" the regular health care system, while 10% reported they were unable to visit a regular general practitioner due to physical or psychological reasons. In the years 2013-2020 46% to 73% of the 8.380 MCH patients had no health care insurance., Conclusion: Patients consulting the MCH suffer from medical conditions typical for the homeless, namely skin diseases, wounds, injuries and behavioural disorders due to alcohol abuse, but also from "typical" symptoms in regular GP care as cough or lower back symptoms. Consultation reasons mostly are acute illnesses. Chronic diseases are equally present in regular GP and MCH patients, but pose a great challenge for the homeless among other things due to their irregular contact with the health care system. The lack of health insurance poses the greatest hurdle to the integration of the homeless into the regular health care system., (© 2023. The Author(s).)

With the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), global researchers were confronted with major challenges. The German National Pandemic Cohort Network (NAPKON) was launched in fall 2020 to effectively leverage resources and bundle research activities in the fight against the coronavirus disease 2019 (COVID-19) pandemic. We analyzed the setup phase of NAPKON as an example for multicenter studies in Germany, highlighting challenges and optimization potential in connecting 59 university and nonuniversity study sites. We examined the ethics application process of 121 ethics submissions considering durations, annotations, and outcomes. Study site activation and recruitment processes were investigated and related to the incidence of SARS-CoV-2 infections. For all initial ethics applications, the median time to a positive ethics vote was less than two weeks and 30 of these study sites (65%) joined NAPKON within less than three weeks each. Electronic instead of postal ethics submission (9.5 days (Q1: 5.75, Q3: 17) vs. 14 days (Q1: 11, Q3: 26), p value = 0.01) and adoption of the primary ethics vote significantly accelerated the ethics application process. Each study center enrolled a median of 37 patients during the 14-month observation period, with large differences depending on the health sector. We found a positive correlation between recruitment performance and COVID-19 incidence as well as hospitalization incidence. Our analysis highlighted the challenges and opportunities of the federated system in Germany. Digital ethics application tools, adoption of a primary ethics vote and standardized formal requirements lead to harmonized and thus faster study initiation processes during a pandemic., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Fatty liver disease or the accumulation of fat in the liver, has been reported to affect the global population. This comes with an increased risk for the development of fibrosis, cirrhosis, and hepatocellular carcinoma. Yet, little is known about the effects of a diet containing high fat and alcohol towards epigenetic aging, with respect to changes in transcriptional and epigenomic profiles. In this study, we took up a multi-omics approach and integrated gene expression, methylation signals, and chromatin signals to study the epigenomic effects of a high-fat and alcohol-containing diet on mouse hepatocytes. We identified four relevant gene network clusters that were associated with relevant pathways that promote steatosis. Using a machine learning approach, we predict specific transcription factors that might be responsible to modulate the functionally relevant clusters. Finally, we discover four additional CpG loci and validate aging-related differential CpG methylation. Differential CpG methylation linked to aging showed minimal overlap with altered methylation in steatosis., (© 2023. The Author(s).)

Background: Older adults with multimorbidity represent a growing segment of the population. Metrics to assess quality, safety and effectiveness of care can support policy makers and healthcare providers in addressing patient needs. However, there is a lack of valid measures of quality of care for this population. In the MULTIqual project, 24 general practitioner (GP)-reported and 14 patient-reported quality indicators for the healthcare of older adults with multimorbidity were developed in Germany in a systematic approach. This study aimed to select, validate and pilot core sets of these indicators., Methods: In a cross-sectional observational study, we collected data in general practices (n = 35) and patients aged 65 years and older with three or more chronic conditions (n = 346). One-dimensional core sets for both perspectives were selected by stepwise backward selection based on corrected item-total correlations. We established structural validity, discriminative capacity, feasibility and patient-professional agreement for the selected indicators. Multilevel multivariable linear regression models adjusted for random effects at practice level were calculated to examine construct validity., Results: Twelve GP-reported and seven patient-reported indicators were selected, with item-total correlations ranging from 0.332 to 0.576. Fulfilment rates ranged from 24.6 to 89.0%. Between 0 and 12.7% of the values were missing. Seventeen indicators had agreement rates between patients and professionals of 24.1% to 75.9% and one had 90.7% positive and 5.1% negative agreement. Patients who were born abroad (- 1.04, 95% CI =  - 2.00/ - 0.08, p = 0.033) and had higher health-related quality of life (- 1.37, 95% CI =  - 2.39/ - 0.36, p = 0.008), fewer contacts with their GP (0.14, 95% CI = 0.04/0.23, p = 0.007) and lower willingness to use their GPs as coordinators of their care (0.13, 95% CI = 0.06/0.20, p < 0.001) were more likely to have lower GP-reported healthcare quality scores. Patients who had fewer GP contacts (0.12, 95% CI = 0.04/0.20, p = 0.002) and were less willing to use their GP to coordinate their care (0.16, 95% CI = 0.10/0.21, p < 0.001) were more likely to have lower patient-reported healthcare quality scores., Conclusions: The quality indicator core sets are the first brief measurement tools specifically designed to assess quality of care for patients with multimorbidity. The indicators can facilitate implementation of treatment standards and offer viable alternatives to the current practice of combining disease-related metrics with poor applicability to patients with multimorbidity., (© 2023. The Author(s).)

Background: Somatic symptom disorder (SSD) is the successor diagnosis of somatoform disorder in the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Relevance and frequency of SSD and its clinical symptoms in general practice are still unknown. We estimate frequencies of patients fulfilling the diagnostic criteria of SSD in general practice., Methods: Mailed and online survey with general practitioners (GP) in Germany using a cross-sectional representative sample from registries of statutory health insurance physicians. GPs estimated percentages of their patients who show the clinical symptoms of SSD according to DSM-5; that is, one or more burdensome somatic symptoms (A criterion), excessive symptom- or illness-related concern, anxiety, or behaviour (B criterion), and persistence of the symptoms over at least 6 months (C criterion). Statistical analysis used means and confidence intervals of estimated patient proportions showing SSD symptoms. Frequency of full-blown SSD was based on the products of these proportions calculated for each GP., Results: Responses from 1728 GPs were obtained. GPs saw the clinical symptoms of SSD fulfilled (A and B criteria) in 21.5% (95% CI: 20.6 to 22.3) of their patients. They further estimated that in 24.3% (95% CI: 23.3 to 25.2) of patients, symptoms would persist, yielding a total of 7.7% (95% CI: 7.1 to 8.4) of patients to have a full-blown SSD., Conclusions: We estimate a frequency of 7.7% of patients in general practice to fulfil the diagnostic criteria of SSD. This number may figure as a reference for the yet to be uncovered prevalence of SSD and it indicates a high clinical relevance of the clinical symptoms of SSD in general practice., Registration: German Clinical Trials Register (Deutschen Register Klinischer Studien, DRKS)., Drks-Id: DRKS00012942. The date the study was registered: October 2nd 2017. The date the first participant was enrolled: February 9th 2018., (© 2022. The Author(s).)

Background and Aims: Treatment with tumor necrosis factor α (TNFα) antagonists in IBD patients suffers from primary non-response rates of up to 40%. Biomarkers for early prediction of therapy success are missing. We investigated the dynamics of gene expression and DNA methylation in blood samples of IBD patients treated with the TNF antagonist infliximab and analyzed the predictive potential regarding therapy outcome., Methods: We performed a longitudinal, blood-based multi-omics study in two prospective IBD patient cohorts receiving first-time infliximab therapy (discovery: 14 patients, replication: 23 patients). Samples were collected at up to 7 time points (from baseline to 14 weeks after therapy induction). RNA-sequencing and genome-wide DNA methylation data were analyzed and correlated with clinical remission at week 14 as a primary endpoint., Results: We found no consistent ex ante predictive signature across the two cohorts. Longitudinally upregulated transcripts in the non-remitter group comprised TH2- and eosinophil-related genes including ALOX15, FCER1A, and OLIG2. Network construction identified transcript modules that were coherently expressed at baseline and in non-remitting patients but were disrupted at early time points in remitting patients. These modules reflected processes such as interferon signaling, erythropoiesis, and platelet aggregation. DNA methylation analysis identified remission-specific temporal changes, which partially overlapped with transcriptomic signals. Machine learning approaches identified features from differentially expressed genes cis-linked to DNA methylation changes at week 2 as a robust predictor of therapy outcome at week 14, which was validated in a publicly available dataset of 20 infliximab-treated CD patients., Conclusions: Integrative multi-omics analysis reveals early shifts of gene expression and DNA methylation as predictors for efficient response to anti-TNF treatment. Lack of such signatures might be used to identify patients with IBD unlikely to benefit from TNF antagonists at an early time point., (© 2022. The Author(s).)

Background: To improve interprofessional collaboration between registered nurses (RNs) and general practitioners (GPs) for nursing home residents (NHRs), the interprof ACT intervention package was developed. This complex intervention includes six components (e.g., shared goal setting, standardized procedures for GPs' nursing home visits) that can be locally adapted. The cluster-randomized interprof ACT trial evaluates the effects of this intervention on the cumulative incidence of hospital admissions (primary outcome) and secondary outcomes (e.g., length of hospital stays, utilization of emergency care services, and quality of life) within 12 months. It also includes a process evaluation which is subject of this protocol. The objectives of this evaluation are to assess the implementation of the interprof ACT intervention package and downstream effects on nurse-physician collaboration as well as preconditions and prospects for successive implementation into routine care., Methods: This study uses a mixed methods triangulation design involving all 34 participating nursing homes (clusters). The quantitative part comprises paper-based surveys among RNs, GPs, NHRs, and nursing home directors at baseline and 12 months. In the intervention group (17 clusters), data on the implementation of preplanned implementation strategies (training and supervision of nominated IPAVs, interprofessional kick-off meetings) and local implementation activities will be recorded. Major outcome domains are the dose, reach and fidelity of the implementation of the intervention package, changes in interprofessional collaboration, and contextual factors. The qualitative part will be conducted in a subsample of 8 nursing homes (4 per study group) and includes repeated non-participating observations and semistructured interviews on the interaction between involved health professionals and their work processes. Quantitative and qualitative data will be descriptively analyzed and then triangulated by means of joint displays and mixed methods informed regression models., Discussion: By integrating a variety of qualitative and quantitative data sources, this process evaluation will allow comprehensive assessment of the implementation of the interprof ACT intervention package, the changes induced in interprofessional collaboration, and the influence of contextual factors. These data will reveal expected and unexpected changes in the procedures of interprofessional care delivery and thus facilitate accurate conclusions for the further design of routine care services for NHRs., Trial Registration: ClinicalTrials.gov NCT03426475 . Registered on 07/02/2018., (© 2022. The Author(s).)

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 (Mdn 1  = 6.82, Mdn 2  = 4.55; U = 11,729, p = 0.001) and participants with mental health diagnoses (Mdn 1  = 9.10, Mdn 2  = 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., (© 2022. The Author(s).)

Background: The 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting., Methods: TOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination)., Results: PCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs)., Conclusions: CDC-guideline adherence can be promoted and measured, and is not associated with worsening of outcomes for people with HIV receiving LTOT for CP. Future work would be needed to document scalability of these results and to determine whether CDC-guideline adherence results in a positive effect on public health. Trial registration https://clinicaltrials.gov/ct2/show/NCT03669939 . Registration date: 9/13/2018., (© 2022. The Author(s).)

Background: Promoter methylation of the DNA repair gene O 6 -methylguanine-DNA methyltransferase (MGMT) is an acknowledged predictive epigenetic marker in glioblastoma multiforme and anaplastic astrocytoma. Patients with methylated CpGs in the MGMT promoter benefit from treatment with alkylating agents, such as temozolomide, and show an improved overall survival and progression-free interval. A precise determination of MGMT promoter methylation is of importance for diagnostic decisions. We experienced that different methods show partially divergent results in a daily routine. For an integrated neuropathological diagnosis of malignant gliomas, we therefore currently apply a combination of methylation-specific PCR assays and pyrosequencing., Results: To better rationalize the variation across assays, we compared these standard techniques and assays to deep bisulfite sequencing results in a cohort of 80 malignant astrocytomas. Our deep analysis covers 49 CpG sites of the expanded MGMT promoter, including exon 1, parts of intron 1 and a region upstream of the transcription start site (TSS). We observed that deep sequencing data are in general in agreement with CpG-specific pyrosequencing, while the most widely used MSP assays published by Esteller et al. (N Engl J Med 343(19):1350-1354, 2000. https://doi.org/10.1056/NEJM200011093431901 ) and Felsberg et al. (Clin Cancer Res 15(21):6683-6693, 2009. https://doi.org/10.1158/1078-0432.CCR-08-2801 ) resulted in partially discordant results in 22 tumors (27.5%). Local deep bisulfite sequencing (LDBS) revealed that CpGs located in exon 1 are suited best to discriminate methylated from unmethylated samples. Based on LDBS data, we propose an optimized MSP primer pair with 83% and 85% concordance to pyrosequencing and LDBS data. A hitherto neglected region upstream of the TSS, with an overall higher methylation compared to exon 1 and intron 1 of MGMT, is also able to discriminate the methylation status., Conclusion: Our integrated analysis allows to evaluate and redefine co-methylation domains within the MGMT promoter and to rationalize the practical impact on assays used in daily routine diagnostics., (© 2022. The Author(s).)

Background: Global migration trends have led to a more diverse population in health care services everywhere, which in turn has set off a paradigm shift away from medical paternalism toward more patient autonomy. Consequently, physicians need to provide a more precise patient-centred healthcare. Professional interpreting appears to play a crucial part in tackling the challenges of language barriers adequately. The aim of this study was to conduct process evaluation through the implementing of video remote interpreting (VR) and telephone remote interpreting (TR) within primary care facilities in the northern German metropolis of Hamburg., Methods: We conducted a three-armed exploratory pilot trial, which compared VR to TR and to a control group (CG) in different primary care settings. We assessed feasibility of implementation, as well as the acceptance of interpreting tools among their users. In addition, we compared the quality of communication as perceived by patients and physicians, as well as the enabling of patient-centred medicine over all three study groups using quantitative questionnaires., Results: 13 practices (7 GPs, 3 Gynaecologists, 3 Paediatricians) took part in this trial. 183 interpreting calls were documented, 178 physicians as well as 127 patients answered their respective questionnaires. The implementation of the VR- und TR-tools went smoothly and they were broadly accepted by their users. However, the tools were used significantly less often than we had anticipated. With regards to quantitative questionnaires, VR scored significantly better than the control group in terms of the perceived quality of communication by both, patients and physicians and enabled of patient-centred medicine., Conclusion: Our main findings were the discrepancy between the assumed high demand of professional interpreting solutions on the one hand and the low willingness of practices to participate on the other. The rather low utilisation rates were also noteworthy. This discrepancy indicates a lack of awareness concerning the adverse effects of using informal or no interpreter in medical settings, which needs to be rectified. Due to the small sample size, all statistical results must be viewed with caution. However, our results show that remote interpreting represents a promising approach to tackling language barriers in primary care settings., (© 2022. The Author(s).)

Background: The implementation of care concepts fitting the needs of patients with chronic heart failure (HF) remains challenging. In this context, psycho-emotional well-being is not routinely assessed, and under-researched despite indications that it is of great relevance for, e.g., acceptance, adherence, and prognosis. The aim of this study was to observe clinical characteristics for their prognostic utility in HF patients, and to compare the patients' health-related quality of life (QoL) with German population norm values., Methods: The current post-hoc analysis was performed on data collected amongst participants of the RECODE-HF study who had fully answered the EQ-5D-5L™ items at both baseline and 12 months (n = 2354). The status in the patients' self-assessment items, EQ-5D visual analog scale (VAS) and EQ-5D index was categorized into worse/unchanged/improved. General linear mixed models (GLMM) with logit link were applied. Subgroups included 630 patients (26.8%) screened positive and 1724 patients (73.2%) screened negative for psychosocial distress (PSD)., Results: The 12-months change in EQ-5D index, generally resulting from change in individual EQ-5D items, additionally associated not only with high NYHA class but sociodemographics (employment/living alone/GP practice years) (96.2% correctly classified in GLMM). The 12- months change in individual QoL aspects showed associations with age*NYHA, gender, body-mass index, and comorbidities dyslipidemia, myocardial infarction, asthma/chronic pulmonary disease. Important social roles were reflected in particular when HF patients lived alone or the doctor mentioned to the patient that the patient had HF. Patients with/without PSD differed in some sociodemographic and clinical parameters. However, no influence of PSD could be demonstrated in the 12-month follow-up of the EQ-5D-5L™. Nonetheless, comparison of the 12-months QoL with general German population norm values by age groups < 75 years and 75+ showed markedly health restrictions in HF patients in all EQ-5D-5L™ aspects., Conclusion: Our analysis revealed different prognostic factors primarily associated with change of burden in different QoL aspects in HF patients. In GP practice it is important to consider in addition to the overall day-related VAS all the individual health-related QoL aspects to take a holistic view of the patient, as well as to pay particular attention to the interrelation of individual characteristics., (© 2021. The Author(s).)

Background: Understanding the influence of genetic variants on DNA methylation is fundamental for the interpretation of epigenomic data in the context of disease. There is a need for systematic approaches not only for determining methylation quantitative trait loci (methQTL), but also for discriminating general from cell type-specific effects., Results: Here, we present a two-step computational framework MAGAR ( https://bioconductor.org/packages/MAGAR ), which fully supports the identification of methQTLs from matched genotyping and DNA methylation data, and additionally allows for illuminating cell type-specific methQTL effects. In a pilot analysis, we apply MAGAR on data in four tissues (ileum, rectum, T cells, B cells) from healthy individuals and demonstrate the discrimination of common from cell type-specific methQTLs. We experimentally validate both types of methQTLs in an independent data set comprising additional cell types and tissues. Finally, we validate selected methQTLs located in the PON1, ZNF155, and NRG2 genes by ultra-deep local sequencing. In line with previous reports, we find cell type-specific methQTLs to be preferentially located in enhancer elements., Conclusions: Our analysis demonstrates that a systematic analysis of methQTLs provides important new insights on the influences of genetic variants to cell type-specific epigenomic variation., (© 2021. The Author(s).)

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 < 0.001). During lockdown, the frequency of five reasons for consultation (-43.0% to -31.5%) and eleven services (-56.6% to -33.5%) had significantly decreased. The multilevel, multivariable analyses showed an average reduction of 94.6 consultations per week (p < 0.001)., 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: Many patients consult their primary care physician with persistent somatic symptoms such as pain or sickness. Quite often these consultations and further diagnostic measures yield no medical explanation for the symptoms - patients and physicians are left in uncertainty. In fact, diagnostic and treatment barriers in primary care hinder timely health-care provision for patients suffering from persistent somatic symptoms (PSS). The significance of individual barriers is still unknown. We compare and quantify these barriers from the perspective of primary care physicians and identify subpopulations of primary care physicians who experience particular barriers as most severe., Methods: We mailed a questionnaire to primary care physicians (PCP) in Germany and asked them which barriers they consider most important. We invited a random sample of 12,004 primary care physicians in eight federal states in Germany. Physicians provided anonymous mailed or online responses. We also mailed a postcard to announce the survey and a mail reminder. Main measures were Likert rating scales of items relating to barriers in the diagnosis and treatment of PSS in primary care. Information on demography and medical practice were also collected., Results: We analyzed 1719 data sets from 1829 respondents. PCPs showed strongest agreement with statements regarding (1.) their lack of knowledge about treatment guidelines, (2.) their perceptions that patients with PSS would expect symptom relief, (3.) their concern to overlook physical disease in these patients, and (4.) their usage of psychotropic drugs with these patients. More experienced PCPs were better able to cope with the possibility of overlooking physical disease than those less experienced., Conclusions: The PCPs in our survey answered that the obligation to rule out severe physical disease and the demand to relieve patients from symptoms belong to the most severe barriers for adequate treatment and diagnosis. Moreover, many physicians admitted to not knowing the appropriate treatment guidelines for these patients. Based on our results, raising awareness of guidelines and improving knowledge about the management of persistent somatic symptoms appear to be promising approaches for overcoming the barriers to diagnosis and treatment of persistent somatic symptoms in primary care., Trial Registration: German Clinical Trials Register (Deutschen Register Klinischer Studien, DRKS) https://www.drks.de/drks&#95;web/setLocale&#95;EN.do The date the study was registered: October 2 nd 2017 The date the first participant was enrolled: February 9 th 2018 DRKS-ID: DRKS00012942.

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: In Germany, up to 50% of nursing home residents are admitted to a hospital at least once a year. It is often unclear whether this is beneficial or even harmful. Successful interprofessional collaboration and communication involving general practitioners (GPs) and nurses may improve medical care of nursing home residents. In the previous interprof study, the six-component intervention package interprof ACT was developed to facilitate collaboration of GPs and nurses in nursing homes. The aim of this study is to evaluate the effectiveness of the interprof ACT intervention., Methods: This multicentre, cluster randomised controlled trial compares nursing homes receiving the interprof ACT intervention package for a duration of 12 months (e.g. comprising appointment of mutual contact persons, shared goal setting, standardised GPs' home visits) with a control group (care as usual). A total of 34 nursing homes are randomised, and overall 680 residents recruited. The intervention package is presented in a kick-off meeting to GPs, nurses, residents/relatives or their representatives. Nursing home nurses act as change agents to support local adaption and implementation of the intervention measures. Primary outcome is the cumulative incidence of hospitalisation within 12 months. Secondary outcomes include admissions to hospital, days admitted to hospital, use of other medical services, prevalence of potentially inappropriate medication and quality of life. Additionally, health economic and a mixed methods process evaluation will be performed., Discussion: This study investigates a complex intervention tailored to local needs of nursing homes. Outcomes reflect the healthcare and health of nursing home residents, as well as the feasibility of the intervention package and its impact on interprofessional communication and collaboration. Because of its systematic development and its flexible nature, interprof ACT is expected to be viable for large-scale implementation in routine care services regardless of local organisational conditions and resources available for medical care for nursing home residents on a regular basis. Recommendations will be made for an improved organisation of primary care for nursing home residents. In addition, the results may provide important knowledge and data for the development and evaluation of further strategies to improve outpatient care for elderly care-receivers., Trial Registration: ClinicalTrials.gov NCT03426475 . Initially registered on 7 February 2018.

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 < 0.001), dermatitis/atopic eczema (4.279, p < 0.001) and psychological disorders (4.056, p < 0.001)., 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.

Background: Some studies, mainly coming from the U.S., indicate disparities in heart failure (HF) treatment according to migration/ethnicity. However, respective results are inconsistent and cannot be transferred to other health care systems. Thus, we will address the following research question: Are there differences in the diagnosis and management of HF between patients with and without a Turkish migration background in Germany?, Methods: A factorial experimental design with video vignettes was applied. In the filmed simulated initial encounters, professional actors played patients, who consulted a primary care physician because of typical HF symptoms. While the dialog was identical in all videos, patients differed in terms of Turkish migration history (no/yes), sex (male/female), and age (55 years/75 years). After viewing the video, primary care physicians (N = 128) were asked standardized and open ended questions concerning their decisions on diagnosis and therapy., Results: Analyses revealed no statistically significant differences (p < 0.05), but a consistent tendency: Primary care doctors more often asked lifestyle and psychosocial questions, they more often diagnosed HF, they gave more advice to rest and how to behave in case of deterioration, they more often auscultated the lung, and more often referred to a specialist when the patient has a Turkish migration history compared to a non-migrant patient. Differences in the medical decisions between the two groups ranged between 1.6 and 15.8%. In 10 out of 12 comparisons, differences were below 10%., Conclusions: Our results indicate that are no significant inequalities in diagnosis and management of HF according to a Turkish migration background in Germany. Primary care physicians' behaviour and medical decision making do not seem to be influenced by the migration background of the patients. Future studies are needed to verify this result and to address inequalities in HF therapy in an advanced disease stage.

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 < 0.001), morbidity (+ 0.10 per disease, p = 0.043), education (high vs. low: - 1.74, p < 0.001), logarithmised household net adjusted disposable income (- 0.93 per step on the logarithmic scale, 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 < 0.001; each contact to a medical specialist: - 0.75, 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).

Background: Studies investigating the longitudinal predictive value of burnout on both effort-reward imbalance (within the working place) and work-family conflict (between work and private life) in residents are lacking. Former cross-sectional studies showed an association of effort-reward imbalance and work family conflict with an elevated burnout risk in physicians., Methods: Data acquisition was carried out within the multi-centric, longitudinal, and prospective "KarMed" study in Germany from 2009 until 2016. Yearly surveys including validated scales: the Maslach Burnout Inventory with its three subscales (emotional exhaustion, personal accomplishment, depersonalisation), the Work-Family Conflict Scale, and the Effort-Reward Imbalance Inventory. Further independent variables were gender and parental status.The analyses were based on general linear models and general linear mixed models with repeated measures designs., Results: Significant time-fixed effects were found for all three subscales of the Maslach Burnout Inventory, with gender effects on the subscales emotional exhaustion and depersonalisation. The parental status had no significant effect on burnout. All estimated means for burnout during 6 years of post-graduate training were higher when work-family conflict and gratification crisis were taken into account. Personal accomplishment increased continuously over time as well showing neither gender differences nor influences by the parental status., Conclusions: Personal accomplishments might act as a buffer compensating to some extent for the physicians' stress experience. Given that burnout may be associated with poor patient care, there is a need to reduce burnout rates and their associated factors in resident physicians.

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).

Background: Cell-type heterogeneity of tumors is a key factor in tumor progression and response to chemotherapy. Tumor cell-type heterogeneity, defined as the proportion of the various cell-types in a tumor, can be inferred from DNA methylation of surgical specimens. However, confounding factors known to associate with methylation values, such as age and sex, complicate accurate inference of cell-type proportions. While reference-free algorithms have been developed to infer cell-type proportions from DNA methylation, a comparative evaluation of the performance of these methods is still lacking., Results: Here we use simulations to evaluate several computational pipelines based on the software packages MeDeCom, EDec, and RefFreeEWAS. We identify that accounting for confounders, feature selection, and the choice of the number of estimated cell types are critical steps for inferring cell-type proportions. We find that removal of methylation probes which are correlated with confounder variables reduces the error of inference by 30-35%, and that selection of cell-type informative probes has similar effect. We show that Cattell's rule based on the scree plot is a powerful tool to determine the number of cell-types. Once the pre-processing steps are achieved, the three deconvolution methods provide comparable results. We observe that all the algorithms' performance improves when inter-sample variation of cell-type proportions is large or when the number of available samples is large. We find that under specific circumstances the methods are sensitive to the initialization method, suggesting that averaging different solutions or optimizing initialization is an avenue for future research., Conclusion: Based on the lessons learned, to facilitate pipeline validation and catalyze further pipeline improvement by the community, we develop a benchmark pipeline for inference of cell-type proportions and implement it in the R package medepir.

Background: Trisomy 21 (T21) is associated with intellectual disability that ranges from mild to profound with an average intellectual quotient of around 50. Furthermore, T21 patients have a high risk of developing Alzheimer's disease (AD) early in life, characterized by the presence of senile plaques of amyloid protein and neurofibrillary tangles, leading to neuronal loss and cognitive decline. We postulate that epigenetic factors contribute to the observed variability in intellectual disability, as well as at the level of neurodegeneration seen in T21 individuals., Materials and Methods: A genome-wide DNA methylation study was performed using Illumina Infinium® MethylationEPIC BeadChips on whole blood DNA of 3 male T21 patients with low IQ, 8 T21 patients with high IQ (4 males and 4 females), and 21 age- and sex-matched control samples (12 males and 9 females) in order to determine whether DNA methylation alterations could help explain variation in cognitive impairment between individuals with T21. In view of the increased risk of developing AD in T21 individuals, we additionally investigated the T21-associated sites in published blood DNA methylation data from the AgeCoDe cohort (German study on Ageing, Cognition, and Dementia). AgeCoDe represents a prospective longitudinal study including non-demented individuals at baseline of which a part develops AD dementia at follow-up., Results: Two thousand seven hundred sixteen differentially methylated sites and regions discriminating T21 and healthy individuals were identified. In the T21 high and low IQ comparison, a single CpG located in the promoter of PELI1 was differentially methylated after multiple testing adjustment. For the same contrast, 69 differentially methylated regions were identified. Performing a targeted association analysis for the significant T21-associated CpG sites in the AgeCoDe cohort, we found that 9 showed significant methylation differences related to AD dementia, including one in the ADAM10 gene. This gene has previously been shown to play a role in the prevention of amyloid plaque formation in the brain., Conclusion: The differentially methylated regions may help understand the interaction between methylation alterations and cognitive function. In addition, ADAM10 might be a valuable blood-based biomarker for at least the early detection of AD.

Background: Chronic heart failure patients typically suffer from tremendous strain and are managed mainly in primary care. New care concepts adapted to the severity of heart failure are a challenge and need to consider health-related quality of life aspects. This is the first psychometric validation of the German EQ-5D-5L™ as a generic instrument for assessing health-related quality of life (HRQOL) in a primary care heart failure patient sample., Methods: Confirmatory factor analysis (CFA) was performed on the baseline EQ-5D-5L™ data from the RECODE-HF study (responses to all items from n = 3225 of 3778 patients). Basic CFA models for HRQOL were calculated based on the EQ-5D-5L™ items using the maximum likelihood (ML) and the asymptotic distribution-free method. In an extended CFA, physical activity and depression were added. The basic CFA ML model was verified for the reduced number of cases of the extended CFA model (n = 3064). In analyses of variance the association of the EQ-5D-5L™ visual analogue scale (VAS) and both the German and the British EQ-5D-5L™ crosswalk index with the SF-36 measure of general health were examined. The discriminant validity was analysed using Pearson's chi-squared tests applying the New York Heart Association classification, for the VAS and indices analyses of variance were calculated., Results: In the basic CFA models the root mean square error of approximation was 0.095 with the ML method, and 0.081 with the asymptotic distribution-free method (Comparative Fit Index > 0.90 for both). Physical activity and depression were confirmed as influential factors in the extended model. The VAS and indices were strongly associated with the SF-36 measure of general health (partial eta-squared 0.525/0.454/0.481; all p <  0.001; n = 3155/3210/3210, respectively), also for physical activity and depression when included together (partial eta-squared 0.050, 0.200/0.047, 0.213/0.051 and 0.270; all p <  0.001; n = 3015/n = 3064/n = 3064, respectively). The discriminant validity analyses showed p-values < 0.001 and small to moderate effect sizes for all EQ-5D-5L™ items. Analyses of variance demonstrated moderate effect sizes for the VAS and indices (0.067/0.087/0.084; all p <  0.001; n = 3110/3171/3171)., Conclusion: The German EQ-5D-5L™ is a suitable method for assessing HRQOL in heart failure patients.

Background: Time constraints during patient visits play a major role for the work stress of primary care physicians. Several studies suggest that there is a critical situation in terms of time constraints in primary care in Germany. Therefore, the following research questions are addressed: (1) What is the time allocated and needed for different types of consultations among primary care physicians in an urban area in Germany? (2) What is the extent of time stress? (3) Are there differences in time stress according to physician characteristics (gender and length of experience) and practice type (single vs. group/shared practice)?, Methods: Data stem from a face-to-face survey of primary care doctors in Hamburg and adjacent regions. A sample of 128 physicians stratified by a combination of physicians' gender and length of experience (≤15 years or > 15 years) was used. Physicians were asked about the time needed (in minutes) to provide high quality of care for patients regarding six types of consultations: (1) new patient appointment, (2) routine consultation, (3) complete physical examination, (4) symptom-oriented examination, (5) check-up, and (6) home visit (without drive). Afterwards, they were asked about the average minutes allocated for the six consultations. Time stress was measured by calculating minutes needed minus minutes available., Results: Average perceived time needed was higher than time allocated for all six types of consultation. However, there were differences in the magnitude of time stress between the consultation types. Time stress was most pronounced and most prevalent in case of a new patient visit. No significant differences in time stress between male and female primary care physicians were found, while less experienced physicians reported more time stress than those with more experience (> 15 years). Physicians working in a single practice had less time stress than those working in a group or shared practice in case of a check-up visit., Conclusions: Perceived time needed is higher than time allocated for various types of consultation among primary care physicians in Germany. Time stress in primary care is particularly pronounced in case of new patient appointments. Early-career physicians are particularly affected by time stress.

Whole-genome sequencing analysis of Vancomycin-resistant Enterococcus faecium isolates from the Frankfurt metropolitan region revealed that 78/94 isolates were MLST type ST117, cgMLST complex type CT71 with a common van B chromosomal insertion site. This indicates circulation of a single VRE clone in a catchment area of 5,000-km 2 with 3 million inhabitants., Competing Interests: Competing interestsThe authors declare that they have no competing interests.

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: The level of quality of care of ambulatory services in Switzerland is almost completely unknown. By adapting existing instruments to the Swiss national context, the present project aimed to define quality indicators (QI) for the measurement of quality of primary care for use on health insurance claims data. These data are pre-existing and available nationwide which provides an excellent opportunity for their use in the context of health care quality assurance., Methods: Pragmatic 6-step process based on informal consensus. Potential QI consisted of recommendations extracted from internationally accepted medical practice guidelines and pre-existing QI for primary care. An independent interdisciplinary group of experts rated potential QI based on explicit criteria related to evidence, relevance for Swiss public health, and controllability in the Swiss primary care context. Feasibility of a preliminary set of QI was tested using claims data of persons with basic mandatory health insurance with insurance at one of the largest Swiss health insurers. This test built the basis for expert consensus on the final set of QI., Results: Of 49 potential indicators, 23 were selected for feasibility testing based on claims data. The expert group consented a final set of 24 QI covering the domains general aspects/ efficiency (7 QI), drug safety (2), geriatric care (4), respiratory disease (2), diabetes (5) and cardiovascular disease (4)., Conclusions: The present project provides the first nationwide applicable explicit evidence-based criteria to measure quality of care of ambulatory primary care in Switzerland. The set intends to increase transparency related to quality and variance of care in Switzerland.

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.

Background: Oldest-old persons frequently receive potentially inappropriate medication. Medication use takes place under the patients' informal caregivers' influence. We explored informal caregivers' perspectives on medication of (relatively) independent oldest-old persons to identify starting points for safer medication prescription/handling., Methods: In this exploratory qualitative interview study we interviewed 45 informal caregivers of 45 oldest-old persons (23 with potentially inappropriate medication/22 without potentially inappropriate medication). Interviews were recorded, transcribed and content analyzed (deductive/inductive coding)., Results: Interviewees had little knowledge about/influence on oldest-old persons' medication, but declared to monitor oldest-old persons' needs for assistance. They were unaware of the concept of potentially inappropriate medication but sometimes sensitive to substance dependency. Most informal caregivers were satisfied with the oldest-old persons' medication and viewed medication as increasing the patients' quality of life. Inadequate communication was found between informal caregivers and general practitioners., Conclusions: Influence of informal caregivers on (relatively) independent oldest-old persons' medication seems low. Stakeholders need to be aware that there is a transitional period where independency of oldest-old persons decreases and support needs increase which may be missed by (in-)formal caregivers or concealed by oldest-old persons. Monitoring patients' medication competencies; measures supporting communication between informal caregivers and health care professionals; provision of educational and support resources for informal caregivers and the acceptance of oldest-old persons' increasing assistance needs may increase medication safety.

Background: The prevalence of pain is very common in the oldest age group. Managing pain successfully is a key topic in primary care, especially within the ageing population. Different care settings might have an impact on the prevalence of pain and everyday life., Methods: Participants from the German longitudinal 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) were asked to rate their severity of pain as well as the impairment with daily activities. Besides gender, age, education, BMI and use of analgesics we focused on the current housing situation and on cognitive state. Associations of the dependent measures were tested using four ordinal logistic regression models. Model 1 and 4 consisted of the overall sample, model 2 and 3 were divided according to no cognitive impairment (NCI) and mild cognitive impairment (MCI)., Results: Results show a decline in pain at very old age but nonetheless a high prevalence among the 85+ year olds. Sixty-three per cent of the participants report mild to severe pain and 69% of the participants mild to extreme impairment due to pain with daily activities. Use of analgesics, depression and living at home with care support are significantly associated with higher and male gender with lower pain ratings., Conclusions: Sufficient pain management among the oldest age group is inevitable. Outpatient care settings are at risk of overlooking pain. Therefore focus should be set on pain management in these settings.

Background: Given both the increase of nursing home residents forecast and challenges of current interprofessional interactions, we developed and tested measures to improve collaboration and communication between nurses and general practitioners (GPs) in this setting. Our multicentre study has been funded by the German Federal Ministry of Education and Research (FK 01GY1124)., Methods: The measures were developed iteratively in a continuous process, which is the focus of this article. In part 1 "exploration of the situation", interviews were conducted with GPs, nurses, nursing home residents and their relatives focusing on interprofessional interactions and medical care. They were analysed qualitatively. Based on these results, in part 2 "development of measures to improve collaboration", ideas for improvement were developed in nine focus groups with GPs and nurses. These ideas were revisited in a final expert workshop. We analysed the focus groups and expert workshop using mind mapping methods, and finally drew up the compilation of measures. In an exploratory pilot study "study part 3" four nursing homes chose the measures they wanted to adopt. These were tested for three months. Feasibility and acceptance of the measures were evaluated via guideline interviews with the stakeholders which were analysed by content analyses., Results: Six measures were generated: meetings to establish common goals, main contact person, standardised pro re nata medication, introduction of name badges, improved availability of nurse/GP and standardised scheduling/ procedure for nursing home visits. In the pilot study, the measures were implemented in four nursing homes. GPs and nurses reviewed five measures as feasible and acceptable, only the designation of a "main contact person" was not considered as an improvement., Conclusions: Six measures to improve collaboration and communication could be compiled in a multistep qualitative process respecting the perspectives of involved stakeholders. Five of the six measures were positively assessed in an exploratory pilot study. They could easily be transferred into the daily routine of other nursing homes, as no special models have to exist in advance. Impact of the measures on patient oriented outcomes should be examined in further research., Trial Registration: Not applicable.

Background: Depression is one of the most common mental disorders in old age and is associated with various negative health consequences for the affected individual. Studies suggest that patients' views on depression have an impact on help-seeking behaviour and treatment. It is thus important to investigate the patient's perspective in order to ascertain optimum management of depression in late life. However, studies on depression and its treatment exploring the perspectives of primary care patients 75 years or older, are rare., Methods: Qualitative data was collected in semi-structured interviews with 12 primary care patients 75 years of age or older with symptoms of depression. Data was analysed using qualitative content analysis., Results: The study's results show the multifaceted views on and treatment of depression in primary care patients 75 years of age or older. Some patients seemed well informed about depression and believed in the efficacy of different treatments, such as medications or psychotherapy. However, some individuals had misconceptions about depression and its treatments. Patients mentioned that they would rather avoid talking about depression within their social network, in part of fear of negative reactions. Furthermore, participants believed that other people had little understanding for people with depression. Patients had different views on the relevance of the general practitioner's (GP) role in treating depression; some patients believed that the GP had little importance in the treatment of depression., Conclusions: This study identified positive views of primary care patients 75 years of age or older towards depression as well as views that might hinder optimal treatments. Exemplary implications for an improved management of depression are: educating older adults about depression via age-specific information and having professionals encourage patients in believing that depression is a recognised disorder.

Background: Depression is a common comorbidity in patients with chronic heart failure (HF) and linked to a wider range of symptoms which, in turn, are linked to a decreased health-related quality of life (HRQOL). Treatment of depression might improve HRQOL but detecting depression is difficult due to the symptom overlap between HF and depression. Therefore, clinical guidelines recommend to routinely screen for depression in HF patients. No studies have so far investigated the treatment after getting aware of a depressive symptomatology and its correlation with HRQOL in primary care HF patients. Therefore, we examined the factors linked to depression treatment and those linked to HRQOL in HF patients. We hypothesized that GPs' awareness of depressive symptomatology was associated with depression treatment and HRQOL in HF patients., Methods: For this observational study, HF patients were recruited in primary care practices and filled out a questionnaire including PHQ-9 and HADS. A total of 574 patients screened positive for depressive symptomatology. Their GPs were interviewed by phone regarding the patients' comorbidities and potential depression treatment. Descriptive and regression analysis were performed., Results: GPs reported various types of depression treatments (including dialogue/counselling by the GP him/herself in 31.8% of the patients). The reported rates differed considerably between GP-reported initiated treatment and patient-reported utilised treatment regarding psychotherapy (16.4% vs. 9.5%) and pharmacotherapy (61.2% vs. 30.3%). The GPs' awareness of depressive symptomatology was significantly associated with the likelihood of receiving pharmacotherapy (OR 2.8; p < 0.001) but not psychotherapy. The patient's HRQOL was not significantly associated with the GPs' awareness of depression., Conclusion: GPs should be aware of the gap between GP-initiated and patient-utilised depression treatments in patients with chronic HF, which might lead to an undersupply of depression treatment. It remains to be investigated why GPs' awareness of depressive symptomatology is not linked to patients' HRQOL. We hypothesize that GPs are aware of cases with reduced HRQOL (which improves under depression treatment) and unaware of cases whose depression do not significantly impair HRQOL, resulting in comparable levels of HRQOL in both groups. This hypothesis needs to be further investigated.

Background: Dementia is an irreversible chronic disease with wide-ranging effects on patients', caregivers' and families' lives. Hospitalizations are significant events for people with dementia. They tend to have poorer outcomes compared to those without dementia. Most of the previous studies focused on diagnoses leading to hospitalizations using claims data. Further factors (e.g. context factors) for hospitalizations are not reproduced in this data. Therefore, we investigated the factors leading to hospitalization with an explorative, qualitative study design., Methods: We interviewed informal caregivers (N = 12), general practitioners (GPs, N = 12) and formal caregivers (N = 5) of 12 persons with dementia using a semi-structured interview guideline. The persons with dementia were sampled using criteria regarding their living situation (home care vs. nursing home care) and gender. The transcripts were analyzed using the method of structuring content analysis., Results: Almost none of the hospitalizations, discussed with the (in-)formal caregivers and GPs, seemed to have been preventable or seemed unjustifiable from the interviewees' points of view. We identified several dementia-specific factors promoting hospitalizations (e.g. the neglect of constricted mobility, the declining ability to communicate about symptoms/accidents and the shift of responsibility from person with dementia to informal or formal caregivers) and context-specific factors promoting hospitalizations (e.g. qualification of nursing home personal, the non-availability of the GP and hospitalizations for examinations/treatments also available in ambulatory settings). Hospitalizations were always the result of the interrelation of two factors: illnesses/accidents and context factors. The impact of both seems to be stronger in presence of dementia., Conclusions: Points for action in terms of reducing hospitalization rates were: better qualified nurses, a 24-h-GP-emergency service and better compensation for ambulatory monitoring/treatments and house calls. Many hospitalizations of people with dementia cannot be prevented. Therefore, hospital staffs need to be better prepared to handle patients with dementia in order to reduce the negative effects of hospitalizations.

Background: Thus far, only a few longitudinal studies investigated the impact of social engagement on health-related quality of life (HRQoL) and depressive symptoms in old age. Therefore, we aimed to examine the impact of social engagement on HRQoL and depressive symptoms in late life., Methods: Individuals aged 75 years and over at baseline were interviewed every 1.5 years in a multicenter prospective cohort study in Germany. While HRQoL was quantified by using the Visual Analogue Scale (EQ VAS) of the EQ-5D instrument, depressive symptoms was assessed by using the Geriatric Depression Scale (GDS). Individuals reported the frequency ("never" to "every day") of social engagement (e.g., engagement in the church, as a volunteer, in a party, or in a club) in the last four weeks. Fixed effects regressions were used to estimate the effect of social engagement on the outcome variables., Results: After adjusting for age, marital status, functional status and chronic diseases, fixed effects regressions revealed that the onset of social engagement markedly increased HRQoL and considerably decreased depressive symptoms in the total sample and in women, but not men., Conclusions: Our findings corroborate the relevance of social engagement for HRQoL and depressive symptoms in old age. Encouraging the individuals to start, maintain and expand social engagement in late life might help to maintain and improve HRQoL and decrease depressive symptoms.

Background: Depression is more prevalent in patients with heart failure (HF) than in those without, but its detection is complicated by the symptom overlap between the two diseases. General practitioners (GPs) are the first point of contact for patients with HF. Therefore, this study aims to investigate GPs' awareness of depression in their HF patients and factors associated with this awareness., Methods: In this cross-sectional, observational study 3224 primary care patients with HF were screened for depressive symptomatology using an algorithm based on the Hospital Anxiety and Depression Scale, the 9-item subscale on Depression of the Patient Health Questionnaire, and selected items from the PROMIS Depression and Anxiety scales. The 272 GPs of all patients involved in the study were interviewed by telephone regarding their patients' somatic and psychological comorbidities. The awareness rates of depressive symptomatology by the patients' GPs are analyzed using descriptive statistics. Logistic regression analyses are applied to investigate the patient- and GP-based factors associated with the GPs' awareness of depressive symptomatology., Results: GPs were aware of their patients' depressive symptomatology in 35% of all cases. Factors associated with the awareness of depressive symptomatology were: higher patient education levels, a history of depression known to the GP, GP-consultations due to emotional distress within the last 6 months, a higher frequency of GP-contacts within the last 6 months, a higher New York Heart Association (NYHA) classification and more severe depressive symptomatology. The GPs' characteristics, including further education in psychology/psychiatry, were not associated with GP awareness., Conclusions: Many aspects, including the definition of awareness and the practical issues in primary care, may contribute to the unexpectedly low awareness rates of depressive symptomatology in HF patients in primary care. Awareness rates might increase, if GPs encouraged their patients to talk about emotional distress, held detailed medical interviews including a patient's history of depression and payed special attention to HF patients with low education levels. However, it remains to be investigated whether GPs' judgement of depressive symptomatology is a better or worse indicator for the future prognosis and quality of life of HF patients than psychiatry based diagnostic criteria.