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The German Centre for Cardiovascular Research (DZHK) is one of the German Centres for Health Research and aims to conduct early and guideline-relevant studies to develop new therapies and diagnostics that impact the lives of people with cardiovascular disease. Therefore, DZHK members designed a collaboratively organised and integrated research platform connecting all sites and partners. The overarching objectives of the research platform are the standardisation of prospective data and biological sample collections among all studies and the development of a sustainable centrally standardised storage in compliance with general legal regulations and the FAIR principles. The main elements of the DZHK infrastructure are web-based and central units for data management, LIMS, IDMS, and transfer office, embedded in a framework consisting of the DZHK Use and Access Policy, and the Ethics and Data Protection Concept. This framework is characterised by a modular design allowing a high standardisation across all studies. For studies that require even tighter criteria additional quality levels are defined. In addition, the Public Open Data strategy is an important focus of DZHK. The DZHK operates as one legal entity holding all rights of data and biological sample usage, according to the DZHK Use and Access Policy. All DZHK studies collect a basic set of data and biosamples, accompanied by specific clinical and imaging data and biobanking. The DZHK infrastructure was constructed by scientists with the focus on the needs of scientists conducting clinical studies. Through this, the DZHK enables the interdisciplinary and multiple use of data and biological samples by scientists inside and outside the DZHK. So far, 27 DZHK studies recruited well over 11,200 participants suffering from major cardiovascular disorders such as myocardial infarction or heart failure. Currently, data and samples of five DZHK studies of the DZHK Heart Bank can be applied for.
Background
The COVID-19 pandemic and the imposed lockdowns severely affected routine care in general and specialized physician practices.
Objective
To describe the long-term impact of the COVID-19 pandemic on the physician services provision and disease recognition in German physician practices and perceived causes for the observed changes.
Design
Observational study based on medical record data and survey data of general practitioners and specialists' practices.
Participants
996 general practitioners (GPs) and 798 specialist practices, who documented 6.1 million treatment cases for medical record data analyses and 645 physicians for survey data analyses.
Main measures
Within the medical record data, consultations, specialist referrals, hospital admissions, and documented diagnoses were extracted for the pandemic (March 2020–September 2021) and compared to corresponding pre-pandemic months in 2019. The additional online survey was used to assess changes in practice management during the COVID-19 pandemic and physicians' perceived main causes of affected primary and specialized care provision.
Main results
Hospital admissions (GPs: −22% vs. specialists: −16%), specialist referrals (−6 vs. −3%) and recognized diseases (−9 vs. −8%) significantly decreased over the pandemic. GPs consultations initially decreased (2020: −7%) but compensated at the end of 2021 (+3%), while specialists' consultation did not (−2%). Physicians saw changes in patient behavior, like appointment cancellation, as the main cause of the decrease. Contrary to this, they also mentioned substantial modifications of practice management, like reduced (nursing) home visits (41%) and opening hours (40%), suspended checkups (43%), and delayed consultations for high-risk patients (71%).
Conclusion
The pandemic left its mark on primary and specialized healthcare provision and its utilization. Both patient behavior and organizational changes in practice management may have caused decreased and non-compensation of services. Evaluating the long-term effect on patient outcomes and identifying potential improvements are vital to better prepare for future pandemic waves.
Background
A redistribution of tasks between specialized nurses and primary care physicians, i.e., models of advanced nursing practice, has the potential to improve the treatment and care of the growing number of people with dementia (PwD). Especially in rural areas with limited access to primary care physicians and specialists, these models might improve PwD’s quality of life and well-being. However, such care models are not available in Germany in regular healthcare. This study examines the acceptance, safety, efficacy, and health economic efficiency of an advanced nursing practice model for PwD in the primary care setting in Germany.
Methods
InDePendent is a two-arm, multi-center, cluster-randomized controlled intervention study. Inclusion criteria are age ≥70 years, cognitively impaired (DemTect ≤8) or formally diagnosed with dementia, and living in the own home. Patients will be recruited by general practitioners or specialists. Randomization is carried out at the physicians’ level in a ratio of 1:2 (intervention vs. waiting-control group). After study inclusion, all participants will receive a baseline assessment and a follow-up assessment after 6 months. Patients of the intervention group will receive advanced dementia care management for 6 months, carried out by specialized nurses, who will conduct certain tasks, usually carried out by primary care physicians. This includes a standardized assessment of the patients’ unmet needs, the generation and implementation of an individualized care plan to address the patients’ needs in close coordination with the GP. PwD in the waiting-control group will receive routine care for 6 months and subsequently become part of the intervention group. The primary outcome is the number of unmet needs after 6 months measured by the Camberwell Assessment of Need for the Elderly (CANE). The primary analysis after 6 months is carried out using multilevel models and will be based on the intention-to-treat principle. Secondary outcomes are quality of life, caregiver burden, acceptance, and cost-effectiveness. In total, n=465 participants are needed to assess significant differences in the number of unmet needs between the intervention and control groups.
Discussion
The study will provide evidence about the acceptance, efficacy, and cost-effectiveness of an innovative interprofessional concept based on advanced nursing care. Results will contribute to the implementation of such models in the German healthcare system. The goal is to improve the current treatment and care situation for PwD and their caregivers and to expand nursing roles.
In rural areas, healthcare providers, patients and relatives have to cover long distances. For specialised ambulatory palliative care (SAPV), a supply radius of max. 30 km is recommended. The aim of this study was to analyse whether there are regional disparities in the supply of SAPV and whether it is associated with the distance between the SAPV team’s site and the patient’s location. Therefore, anonymised data of the Association of Statutory Health Insurance Physicians of the Federal State of Mecklenburg-Western Pomerania (M-V) were retrospectively analysed for the period of 2014–2017. Identification as a palliative patient was based on palliative-specific items from the ambulatory reimbursement catalogue. In total, 6940 SAPV patients were identified; thereof, 48.9% female. The mean age was 73.3 years. For 28.3% of the identified SAPV patients (n = 1961), the SAPV teams had a travel distance of >30 km. With increasing distance, the average number of treatment days per patient increased. It was found that there are regional disparities in the provision of SAPV services in M-V and that local structures have an important impact on regional supply patterns. The distance between the SAPV team’s site and the patient’s location is not the only determining factor; other causes must be considered.
Person-centered care (PCC) requires knowledge about patient preferences. An analytic hierarchy process (AHP) is one approach to quantify, weigh and rank patient preferences suitable for People living with Dementia (PlwD), due to simple pairwise comparisons of individual criteria from a complex decision problem. The objective of the present study was to design and pretest a dementia-friendly AHP survey. Methods: Two expert panels consisting of n = 4 Dementia Care Managers and n = 4 physicians to ensure content-validity, and “thinking-aloud” interviews with n = 11 PlwD and n = 3 family caregivers to ensure the face validity of the AHP survey. Following a semi-structured interview guide, PlwD were asked to assess appropriateness and comprehensibility. Data, field notes and partial interview transcripts were analyzed with a constant comparative approach, and feedback was incorporated continuously until PlwD had no further comments or struggles with survey completion. Consistency ratios (CRs) were calculated with Microsoft® Excel and ExpertChoice Comparion®. Results: Three main categories with sub-categories emerged: (1) Content: clear task introduction, (sub)criteria description, criteria homogeneity, (sub)criteria appropriateness, retest questions and sociodemography for heterogeneity; (2) Format: survey structure, pairwise comparison sequence, survey length, graphical design (incl. AHP scale), survey procedure explanation, survey assistance and response perspective; and (3) Layout: easy wording, short sentences and visual aids. Individual CRs ranged from 0.08 to 0.859, and the consolidated CR was 0.37 (0.038). Conclusions: Our formative qualitative study provides initial data for the design of a dementia-friendly AHP survey. Consideration of our findings may contribute to face and content validity in future quantitative preference research in dementia.
This study aims to describe social network and social participation and to assess associations with depressive symptoms in older persons with increased risk for dementia in Germany. We conducted a cross-sectional observational study in primary care patients (aged 60–77) as part of a multicenter cluster-randomized controlled trial (AgeWell.de). We present descriptive and multivariate analyses for social networks (Lubben Social Network Scale and subscales) and social participation (item list of social activities) and analyze associations of these variables with depressive symptoms (Geriatric Depression Scale). Of 1030 included patients, 17.2% were at risk for social isolation (Lubben Social Network Scale < 12). Looking at the subscales, a reduced non-family network was found almost twice as often as a reduced family network. Patients with depressive symptoms had significantly smaller social networks than patients without depression (p < 0.001). They rather engaged in social activities of low involvement level or no weekly social activity at all (p < 0.001). The study shows associations of depressive symptoms with a decreased social network and less social participation in elderly participants. Sufficient non-family contacts and weekly social activities seem to play an important role in mental health and should be encouraged in elderly primary care patients.
Background: Multimorbidity is a common issue in aging societies and is usually associated with dementia in older people. Physical activity (PA) may be a beneficial nonpharmacological strategy for patients with complex health needs. However, insufficient PA is predominant in this population. Thus, there is an evident need to expand the knowledge on potential determinants influencing PA engagement among elderly persons at risk of dementia and multimorbidity. Methods: We used baseline data from the multicenter, cluster-randomized controlled AgeWell.de study. The main aim was to describe PA engagement and identify potential PA determinants in a sample of community-dwelling Germans aged 60–77 years old with an increased risk of dementia and multimorbidity. Results: Of the 1030 included participants, approximately half (51.8%) engaged in PA ≥2 times/week for at least 30 min at baseline. We identified self-efficacy (beta = 0.202, (p < 0.001) and BMI (beta = −0.055, (p < 0.001) as potential PA determinants. Conclusions: The identified determinants, self-efficacy, and BMI are consistent with those reported in the literature. Specific knowledge on PA determinants and stages of change in persons with risk of dementia and multimorbidity might guide the development of effective future prevention measures and health services tailored to this population. Trial registration: German Clinical Trials Register (reference number: DRKS00013555).
Background
The national Network Genomic Medicine (nNGM) Lung Cancer provides comprehensive and high-quality multiplex molecular diagnostics and standardized personalized treatment recommendation for patients with advanced non-small cell lung cancer (aNSCLC) in Germany. The primary aim of this study was to investigate the effectiveness of the nNGM precision medicine program in terms of overall survival (OS) using real-world data (RWD).
Methods
A historical nationwide cohort analysis of patients with aNSCLC and initial diagnosis between 04/2019 and 06/2020 was conducted to compare treatment and OS of patients with and without nNGM-participation. Patients participating within the nNGM (nNGM group) were selected based on a prospective nNGM database. The electronic health records (EHR) of the prospective nNGM database were case-specifically linked to claims data (AOK, German health insurance). The control group was selected from claims data of patients receiving usual care without nNGM-participation (non-nNGM group). The minimum follow-up period was six months.
Findings
Overall, n = 509 patients in the nNGM group and n = 7213 patients in the non-nNGM group met the inclusion criteria. Patients participating in the nNGM had a significantly improved OS compared to the non-nNGM group (median OS: 10.5 months vs. 8.7 months, p = 0.008, HR = 0.84, 95% CI: 0.74–0.95). The 1-year survival rates were 46.8% (nNGM) and 41.3% (non-nNGM). The use of approved tyrosine kinase inhibitors (TKI) in the first-line setting was significantly higher in the nNGM group than in the non-nNGM group (nNGM: 8.4% (43/509) vs. non-nNGM: 5.1% (366/7213), p = 0.001). Overall, patients receiving first-line TKI treatment had significantly higher 1-year OS rates than patients treated with PD-1/PD-L1 inhibitors and/or chemotherapy (67.2% vs. 40.2%, p < 0.001).
Interpretation
This is the first study to demonstrate a significant survival benefit and higher utilization of targeted therapies for aNSCLC patients participating within nNGM. Our data indicate that precision medicine programs can enhance collaborative personalized lung cancer care and promote the implementation of treatment innovations and the latest scientific knowledge into clinical routine care.
Funding
The study was funded by the AOK Federal Association Germany.
Background: Person-centered care (PCC) requires knowledge about patient preferences. This formative qualitative study aimed to identify (sub)criteria of PCC for the design of a quantitative, choice-based instrument to elicit patient preferences for person-centered dementia care. Method: Interviews were conducted with n = 2 dementia care managers, n = 10 People living with Dementia (PlwD), and n = 3 caregivers (CGs), which followed a semi-structured interview guide including a card game with PCC criteria identified from the literature. Criteria cards were shown to explore the PlwD’s conception. PlwD were asked to rank the cards to identify patient-relevant criteria of PCC. Audios were verbatim-transcribed and analyzed with qualitative content analysis. Card game results were coded on a 10-point-scale, and sums and means for criteria were calculated. Results: Six criteria with two sub-criteria emerged from the analysis; social relationships (indirect contact, direct contact), cognitive training (passive, active), organization of care (decentralized structures and no shared decision making, centralized structures and shared decision making), assistance with daily activities (professional, family member), characteristics of care professionals (empathy, education and work experience) and physical activities (alone, group). Dementia-sensitive wording and balance between comprehensibility vs. completeness of the (sub)criteria emerged as additional themes. Conclusions: Our formative study provides initial data about patient-relevant criteria of PCC to design a quantitative patient preference instrument. Future research may want to consider the balance between (sub)criteria comprehensibility vs. completeness.
Abstract
Aims
To demonstrate the attitudes of general practitioners (GPs), nurses, persons with dementia, and caregiver towards suitable tasks and qualification needs for and the acceptance and impact of advanced nursing roles in German dementia primary care.
Design
Observational study using a questionnaire survey with 225 GPs, 232 nurses, 211 persons with dementia, and 197 caregivers, conducted between December 2017–August 2018.
Methods
A questionnaire was generated that includes specific assessment, prescription, and monitoring tasks of advanced nursing roles in dementia primary care as well as qualification requirements for and the acceptance and the impact of advanced nursing roles. Data were analysed using descriptive statistics. Group differences were assessed using the Fisher's exact test.
Results
Advanced nursing roles were highly appreciated across all groups. Assessment and monitoring tasks were rated as highly suitable, and prescription authorities as moderately suitable. Nurses felt less confident in assessment and monitoring, but more confident in prescribing as practitioners expected. Patients and caregivers would appreciate a takeover of tasks by nurses; nurses and practitioners preferred a delegation. A dementia‐specific qualification was rated as best suitable for advanced nursing roles, followed by ‘no specific qualification’ if medical tasks that only can be carried out by practitioners were delegated and an academic degree if tasks were substituted. Advanced nursing roles were rated as beneficial, strengthening the confidence in nursing care and improving the cooperation between professionals and the treatment. Practitioners assumed that advanced nursing roles would improve job satisfaction of nurses, which was not confirmed by nurses.
Conclusion
There is an extended consensus towards the enlargement of advanced nursing roles, represented by high endorsement, acceptance, and willingness to reorganize tasks.
Impact
Results debunk the common notion that German practitioners would be reluctant towards advanced nursing roles and a takeover of current practitioner tasks, supporting the implementation of advanced nursing roles in Germany.