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Background
The Federal Ministry of Education and Research of Germany (BMBF) funds a network of university medicines (NUM) to support COVID-19 and pandemic research at national level. The “COVID-19 Data Exchange Platform” (CODEX) as part of NUM establishes a harmonised infrastructure that supports research use of COVID-19 datasets. The broad consent (BC) of the Medical Informatics Initiative (MII) is agreed by all German federal states and forms the legal base for data processing. All 34 participating university hospitals (NUM sites) work upon a harmonised infrastructural as well as legal basis for their data protection-compliant collection and transfer of their research dataset to the central CODEX platform. Each NUM site ensures that the exchanged consent information conforms to the already-balloted HL7 FHIR consent profiles and the interoperability concept of the MII Task Force “Consent Implementation” (TFCI). The Independent Trusted Third-Party (TTP) of the University Medicine Greifswald supports data protection-compliant data processing and provides the consent management solutions gICS.
Methods
Based on a stakeholder dialogue a required set of FHIR-functionalities was identified and technically specified supported by official FHIR experts. Next, a “TTP-FHIR Gateway” for the HL7 FHIR-compliant exchange of consent information using gICS was implemented. A last step included external integration tests and the development of a pre-configured consent template for the BC for the NUM sites.
Results
A FHIR-compliant gICS-release and a corresponding consent template for the BC were provided to all NUM sites in June 2021. All FHIR functionalities comply with the already-balloted FHIR consent profiles of the HL7 Working Group Consent Management. The consent template simplifies the technical BC rollout and the corresponding implementation of the TFCI interoperability concept at the NUM sites.
Conclusions
This article shows that a HL7 FHIR-compliant and interoperable nationwide exchange of consent information could be built using of the consent management software gICS and the provided TTP-FHIR Gateway. The initial functional scope of the solution covers the requirements identified in the NUM-CODEX setting. The semantic correctness of these functionalities was validated by project-partners from the Ludwig-Maximilian University in Munich. The production rollout of the solution package to all NUM sites has started successfully.
Background: A telemedicine care concept based on telephone contacts and individualized text messages was developed for patients with mental disorders to continue treatment after therapy in a psychiatric day hospital. The primary objective of this study was to evaluate the effectiveness of the telemedicine interventions. Methods: The study had a 3-armed, randomized design with 2 intervention arms (intervention 1: telephone contacts; intervention 2: telephone contacts and short text messages; both took place over a period of 6 months and in addition to usual care), and a control group with usual care. Primary outcomes were 18-item Brief Symptom Inventory (BSI-18) scores for anxiety, depression and somatization. All participants were recruited from psychiatric day hospitals. The study was registered in the German Clinical Trials Register (DRKS00000662). Results: 113 participants were analyzed 6 months after starting the intervention. The average BSI-18 anxiety score after 6 months was -2.04 points lower in intervention group 2 than in the control group (p value: 0.042). The difference in BSI depression score between these two groups was marginally significant (p value: 0.1), with an average treatment effect of -1.73. In an exploratory sensitivity analysis restricted to the 75% of patients with the highest symptom scores at baseline, intervention group 1 yielded a significant effect for anxiety and depression compared to the control group (p = 0.036 and 0.046, respectively). Conclusions: Telemedicine provides a novel option in psychiatric ambulatory care with statistically significant effects on anxiety. A positive tendency was observed for depression, especially in cases with higher symptom load at baseline.
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.
Introduction: Hearing and vision loss are highly prevalent in elderly adults, and thus frequently occur in conjunction with cognitive impairments. Studies have shown that hearing impairment is associated with a higher risk of dementia. However, evidence concerning the association between vision loss and dementia, as well as the co-occurrence of vision and hearing loss and dementia, has been inconclusive.
Objectives: To assess the association between: (i) either hearing or vision loss and the risk of dementia, as well as between; and (ii) the combination of both sensory impairments and the risk of dementia.
Methods: This case-control study was based on a 5-year data set that included patients aged 65 years and older who had initially been diagnosed with dementia diseases by one of 1,203 general practitioners in Germany between January 2013 and December 2017. In total, 61,354 identified dementia cases were matched to non-dementia controls, resulting in a sample size of 122,708 individuals. Hearing loss and vision loss were identified using the ICD-10 diagnoses documented in the general practitioners’ files prior to the initial dementia diagnosis. Multivariate logistic regression models were fitted to evaluate the associations between visual and/or hearing impairment and the risk of dementia and controlled for sociodemographic and clinical variables.
Results: Hearing impairment was documented in 11.2% of patients with a dementia diagnosis and 9.5% of patients without such a diagnosis. Some form of vision impairment was documented in 28.4% of patients diagnosed with dementia and 28.8% of controls. Visual impairment was not significantly associated with dementia (OR = 0.97, CI = 95% 0.97–1.02, p = 0.219). However, patients with hearing impairment were at a significantly higher risk of developing dementia (OR = 1.26, CI = 95% 1.15–1.38, p < 0.001), a finding that very likely led to the observed significant association of the combination of both visual and hearing impairments and the risk of dementia (OR = 1.14, CI = 95% 1.04–1.24, p = 0.005).
Discussion: This analysis adds important evidence that contributes to the limited body of knowledge about the association between hearing and/or vision loss and dementia. It further demonstrates that, of the two, only hearing impairment affects patients’ cognition and thus contributes to dementia risk.
Background
Vulnerable groups, e.g. persons with mental illness, neurological deficits or dementia, are often excluded as participants from research projects because obtaining informed consent can be difficult and tedious. This may have the consequence that vulnerable groups benefit less from medical progress. Vulnerable persons are often supported by a legal guardian in one or more demands of their daily life. We examined the attitudes of legal guardians and legally supervised persons towards medical research and the conditions and motivations to participate in studies.
Methods
We conducted a cross-sectional study with standardized surveys of legal guardians and legally supervised persons. Two separate questionnaires were developed for the legal guardians and the supervised persons to asses previous experiences with research projects and the reasons for participation or non-participation. The legal guardians were recruited through various guardianship organizations. The supervised persons were recruited through their legal guardian and from a previous study among psychiatric patients. The data were analysed descriptively.
Results
Alltogether, 82 legal guardians and 20 legally supervised persons could be recruited. Thereof 13 legal guardians (15.6%) and 13 legally supervised persons (65.0%) had previous experience with research projects. The majority of the guardians with experience in research projects had consented the participation of their supervised persons (n = 12 guardians, 60.0%; in total n = 16 approvals). The possible burden on the participating person was given as the most frequent reason not to participate both by the guardians (n = 44, 54.4%) and by the supervised persons (n = 3, 30.0%). The most frequent motivation to provide consent to participate in a research study was the desire to help other patients by gaining new scientific knowledge (guardians: n = 125, 78.1%; supervised persons: n = 10, 66.6%).
Conclusions
Overall, an open attitude towards medical research can be observed both among legal guardians and supervised persons. Perceived risks and no sense recognized in the study are reasons for not participating in medical research projects.
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.
The impact of the COVID-19 pandemic on social-emotional developmental risks (SE-DR) of preschool children is largely unknown. Therefore, the aim of this prospective longitudinal dynamic cohort study was to assess changes in preschoolers’ SE-DR from before the pandemic to after the first COVID-19 wave. SE-DR were assessed annually with the instrument “Dortmund Developmental Screening for Preschools” (DESK). Longitudinal DESK data from 3- to 4-year-old children who participated both in survey wave (SW) three (DESK-SW3, 2019) and SW four (DESK-SW4, 2020) from August 1 to November 30 were used, respectively. Additionally, data from previous pre-pandemic SW were analyzed to contextualize the observed changes (SW1: 2017; SW2: 2018). A total of N = 786 children were included in the analysis. In the pre-pandemic DESK-SW3, the proportion of children with SE-DR was 18.2%, whereas in DESK-SW4 after the first COVID-19 wave, the proportion decreased to 12.4% (p = 0.001). Thus, the prevalence rate ratio (PRR) was 0.68. Compared to data from previous SW (SW1-SW2: PRR = 0.88; SW2-SW3: PRR = 0.82), this result represents a notable improvement. However, only short-term effects were described, and the study region had one of the highest preschool return rates in Germany. Further studies are needed to examine long-term effects of the pandemic on preschoolers’ SE-DR.
Background: Annual transfusion rates in many European countries range between 25 and 35 red blood cell concentrates (RBCs)/1,000 population.It is unclear why transfusion rates in Germany are considerably higher (approx. 50–55 RBCs/1,000 population). Methods: We assessed the characteristics of transfusion recipients at all hospitals of the German federal state Mecklenburg-Western Pomerania during a 10-year longitudinal study. Results: Although 75% of patients received ≤4 RBCs/patient in 2015 (1 RBC: 11.3%; 2 RBCs: 42.6%; 3 RBCs: 6.3%; 4 RBCs: 15.0%), the mean transfusion index was 4.6 RBCs due to a minority of patients with a high transfusion demand. Two thirds of all RBCs were transfused to only 25% of RBC recipients. Consistently, male patients received a higher number of RBCs (2005: 54.2%; 2015: 56.8%) and had a higher mean transfusion index than female patients (mean 5.1 ± 7.2; median 2; inter-quartile range [IQR] 2–4 vs. mean 4.0 ± 5.8; median 2; IQR 2–4). The absolute transfusion demand decreased between 2005 and 2015 by 13.5% due to a composite of active reduction (clinical practice change) and population decline in the 65- to 75-year age group (lower birth rate cohort 1940–1950); however, with major differences between hospitals (range from –61.0 to +41.4%). Conclusion: Transfusion demand in a population could largely be driven by patients with high transfusion demand. Different treatment practices in this group of patients probably add to the major differences in transfusion demand per 1,000 individuals between countries. The available data cannot prove this hypothesis. Implementation of a diagnosis-related group-based monitoring system is urgently needed to allow informative monitoring on the population level and meaningful comparisons between transfusion practices.
This dynamic cohort was established to evaluate the targeted individual promotion of children affected by developmental risks as part of the German federal state law for child day-care and preschools in Mecklenburg-Western Pomerania. The project has been conducted in preschools in regions with a low socio-economic profile since 2011. Since 2017, the revision of the standardized Dortmund Developmental Screening for Preschools (DESK 3–6 R) has been applied. Developmental risks of 3 to 6-year-old children in the domains of motor, linguistic, cognitive and social competencies are monitored. The cohort is followed up annually. In 2020, n = 7,678 children from n = 152 preschools participated. At the baseline (2017), n = 8,439 children participated. Due to the defined age range of this screening, 3,000 to 4,000 5-6-year-old children leave the cohort annually. Simultaneously, an approximately equal number of 3-year-old children enters the cohort per survey wave. N = 702 children participated in all 4 survey waves. On the basis of DESK 3–6 R scores available from survey waves 2017 to 2019 it is possible to compute expected values for the survey wave 2020 and to compare those with the measured values to evaluate the effects of the COVID-19 pandemic (i.e. parental home care due to restrictions related to COVID-19).