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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.
Dementia is a leading cause of disability and dependency in older people worldwide. As the number of people affected increases, so does the need for innovative care models. Dementia care management (DCM) is an empirically validated approach for improving the care and quality of life for people with dementia (PwD) and caregivers. The aim of this study is to investigate the influencing factors and critical pathways for the implementation of a regionally adapted DCM standard in the existing primary care structures in the German region of Siegen-Wittgenstein (SW). Utilizing participatory research methods, five local health care experts as co-researchers conducted N = 13 semi-structured interviews with 22 local professionals and one caregiver as peer reviewers. Data collection and analysis were based on the Consolidated Framework for Implementation Research (CFIR). Our results show that among the most mentioned influencing factors, three CFIR constructs can be identified as both barriers and facilitators: Patients’ needs and resources, Relative advantage, and Cosmopolitanism. The insufficient involvement of relevant stakeholders is the major barrier and the comprehensive consideration of patient needs through dementia care managers is the strongest facilitating factor. The study underlines the vital role of barrier analysis in site-specific DCM implementation.
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.
The associations of thyroid function parameters with non-alcoholic fatty liver disease (NAFLD) and hepatic iron overload are not entirely clear. We have cross-sectionally investigated these associations among 2734 participants of two population-based cross-sectional studies of the Study of Health in Pomerania. Serum levels of thyroid-stimulating hormone (TSH), free tri-iodothyronine (fT3), and free thyroxine (fT4) levels were measured. Liver fat content (by proton-density fat fraction) as well as hepatic iron content (by transverse relaxation rate; R2*) were assessed by quantitative MRI. Thyroid function parameters were associated with hepatic fat and iron contents by median and logistic regression models adjusted for confounding. There were no associations between serum TSH levels and liver fat content, NAFLD, or hepatic iron overload. Serum fT4 levels were inversely associated with liver fat content, NAFLD, hepatic iron contents, and hepatic iron overload. Serum fT3 levels as well as the fT3 to fT4 ratio were positively associated with hepatic fat, NAFLD, hepatic iron contents, but not with hepatic iron overload. Associations between fT3 levels and liver fat content were strongest in obese individuals, in which we also observed an inverse association between TSH levels and NAFLD. These findings might be the result of a higher conversion of fT4 to the biologically active form fT3. Our results suggest that a subclinical hyperthyroid state may be associated with NAFLD, particularly in obese individuals. Furthermore, thyroid hormone levels seem to be more strongly associated with increased liver fat content compared to hepatic iron content.
Abstract
The increasing global prevalence of dementia demands concrete actions that are aimed strategically at optimizing processes that drive clinical innovation. The first step in this direction requires outlining hurdles in the transition from research to practice. The different parties needed to support translational processes have communication mismatches; methodological gaps hamper evidence‐based decision‐making; and data are insufficient to provide reliable estimates of long‐term health benefits and costs in decisional models. Pilot projects are tackling some of these gaps, but appropriate methods often still need to be devised or adapted to the dementia field. A consistent implementation perspective along the whole translational continuum, explicitly defined and shared among the relevant stakeholders, should overcome the “research‐versus‐adoption” dichotomy, and tackle the implementation cliff early on. Concrete next steps may consist of providing tools that support the effective participation of heterogeneous stakeholders and agreeing on a definition of clinical significance that facilitates the selection of proper outcome measures.
Background
The care of palliative patients takes place as non-specialized and specialized care, in outpatient and inpatient settings. However, palliative care is largely provided as General Outpatient Palliative Care (GOPC). This study aimed to investigate whether the survival curves of GOPC patients differed from those of the more intensive palliative care modalities and whether GOPC palliative care was appropriate in terms of timing.
Methods
The study is based on claims data from a large statutory health insurance. The analysis included 4177 patients who received palliative care starting in 2015 and who were fully insured 1 year before and 1 year after palliative care or until death. The probability of survival was observed for 12 months. Patients were classified into group A, which consisted of patients who received palliative care only with GOPC, and group B including patients who received inpatient or specialized outpatient palliative care. Group A was further divided into two subgroups. Patients who received GOPC on only 1 day were assigned to subgroup A1, and patients who received GOPC on two or more days were assigned to subgroup A2. The survival analysis was carried out using Kaplan-Meier curves. The median survival times were compared with the log-rank test.
Results
The survival curves differed between groups A and B, except in the first quartile of the survival distribution. The median survival was significantly longer in group A (137 days, n = 2763) than in group B (47 days, n = 1424, p < 0.0001) and shorter in group A1 (35 days, n = 986) than in group A2 (217 days, n = 1767, p < 0.0001). The survival rate during the 12-month follow-up was higher in group A (42%) than in group B (11%) and lower in group A1 (38%) than in group A2 (44%).
Conclusions
The results of the analysis revealed that patients who received the first palliative care shortly before death suspected insufficient care, especially patients who received GOPC for only 1 day and no further palliative care until death or 12-month follow-up. Palliative care should start as early as necessary and be continuous until the end of life.
Background
Over the course of the COVID-19 pandemic, previous studies have shown that the physical as well as the mental health of children and adolescents significantly deteriorated. Future anxiety caused by the COVID-19 pandemic and its associations with quality of life has not previously been examined in school children.
Methods
As part of a cross-sectional web-based survey at schools in Mecklenburg-Western Pomerania, Germany, two years after the outbreak of the pandemic, school children were asked about COVID-19-related future anxiety using the German epidemic-related Dark Future Scale for children (eDFS-K). Health-related quality of life (HRQoL) was assessed using the self-reported KIDSCREEN-10. The eDFS-K was psychometrically analyzed (internal consistency and confirmatory factor analysis) and thereafter examined as a predictor of HRQoL in a general linear regression model.
Results
A total of N = 840 8–18-year-old children and adolescents were included in the analysis. The eDFS-K demonstrated adequate internal consistency reliability (Cronbach's α = 0.77), and the confirmatory factor analysis further supported the one-factor structure of the four-item scale with an acceptable model fit. Over 43% of students were found to have low HRQoL. In addition, 47% of the students sometimes to often reported COVID-19-related fears about the future. Children with COVID-19-related future anxiety had significantly lower HRQoL (B = – 0.94, p < 0.001). Other predictors of lower HRQoL were older age (B = – 0.63, p < 0.001), and female (B = – 3.12, p < 0.001) and diverse (B = – 6.82, p < 0.001) gender.
Conclusion
Two years after the outbreak of the pandemic, school-aged children continue to exhibit low HRQoL, which is further exacerbated in the presence of COVID-19-related future anxiety. Intervention programs with an increased focus on mental health also addressing future anxiety should be provided.
Literature shows that people with a migration background (PwM) with dementia are an especially vulnerable group. Data on the number of PwM with dementia in Germany is scarce meaning the healthcare system faces a challenge of an unknown magnitude. They are mostly not part of the healthcare landscape and lack knowledge about dementia and healthcare services. Healthcare professionals and services do not seem to be culturally sensitive enough and not adequately equipped to take care of PwM with dementia. Therefore, this work focuses on a) estimating the number of PwM with dementia broken down by country of origin and federal state; b) exploring the caregiving experience, barriers of healthcare utilisation and measures to increase utilisation; and c) determining the scope of culturally sensitive information and healthcare services as well as projects on dementia and migration in Germany. A combination of quantitative and qualitative research methods as well as a scoping review are applied to examine the research focus.
Calculations show that an estimated 96,500 PwM have dementia, presumably mostly originating from Poland, Italy, Turkey, Romania, and the Russian Federation. The majority of affected PwM live in North Rhine-Westphalia, Baden-Württemberg, and Bavaria. Family members experience similar challenges and consequences as non-migrants in the care of a person with dementia. PwM lack sufficient knowledge of dementia and information regarding the available healthcare services. These are only two of the reasons why the healthcare system is not utilised. To increase utilisation, services should be culturally sensitive and information easily accessible. In addition, easier navigation and the expansion of existing healthcare structures is needed. The scoping review identified 48 culturally sensitive healthcare and information services and projects for PwM with dementia. The majority are located in North Rhine-Westphalia, Baden-Württemberg, Bavaria, and Hesse, which mirrors the distribution of PwM with dementia in Germany. For the most part, these services offer counselling in different languages. These results confirm that PwM (with dementia) and healthcare professionals need in-depth education on this topic. There should be a focus on the design of information and healthcare services that are tailored in a culturally sensitive way. This dissertation further indicates that culturally sensitive healthcare services, personalised for individual situations on site, should be expanded and also facilitated by not only healthcare professionals and service providers but also by law- and decision-makers. Furthermore, there is a need for cooperation between researchers, healthcare professionals, service providers, healthcare systems, law-makers, and other stakeholders in the field on a national and an international level.
Vulnerable Personengruppen werden häufig von Forschungsprojekten ausgeschlossen, weil es aufwendig und schwierig ist eine gesetzeskonforme Einwilligung zu erhalten. Zu der Gruppe vulnerabler Personen zählen z.B. Menschen mit psychischen Erkrankungen, neurologischen Defiziten oder Demenz. Häufig werden für diese Personen gesetzliche Betreuer bestellt. Aufgrund der Alterung der Gesellschaft ist von einer steigenden Anzahl pflege- und betreuungsbedürftiger Menschen auszugehen. Um die Anzahl vulnerabler Personen in medizinischen Forschungsprojekten erhöhen zu können, ist es wichtig, die Beweggründe für die Zustimmung oder Ablehnung einer Teilnahme an wissenschaftlichen Forschungsprojekten von gesetzlichen Betreuern und gesetzlich betreuten Personen zu verstehen.
Als Einschlusskriterium für die Teilnehmerinnen und Teilnehmer galt, als gesetzlicher Betreuer oder gesetzlich betreute Person registriert zu sein. Für die gesetzlichen Betreuer und die gesetzlich betreuten Personen wurden zwei separate Fragebögen entwickelt, um vorhandene Forschungserfahrungen und Gründe für Zustimmung oder Ablehnung einer Teilnahme an wissenschaftlichen Forschungsprojekten zu erfassen. Die gesetzlichen Betreuer wurden über verschiedene Betreuungsvereine und Betreuungsbehörden rekrutiert. Einige der gesetzlich betreuten Personen wurden über ihre gesetzlichen Betreuer rekrutiert. Weitere betreute Personen wurden aus der Tecla-Studie gewonnen, welche in der Vergangenheit am Institut für Community Medicine der Universitätsmedizin Greifswald durchgeführt wurde. Die Auswertung der erhobenen Daten erfolgte deskriptiv.
Insgesamt konnten 82 gesetzliche Betreuer und 20 gesetzlich betreute Personen rekrutiert werden. Davon konnten 13 der gesetzlichen Betreuer (15,6%) und 13 gesetzlich betreute Personen (65,0%) bereits Forschungserfahrung vorweisen. Die Mehrheit der gesetzlichen Betreuer mit Erfahrung in Forschungsprojekten hatte der Teilnahme ihrer betreuten Personen zugestimmt (n=12, 60,0%; insgesamt n=16 Zustimmungen). Eine zu große Belastung der teilnehmenden Person wurde sowohl von den Erziehungsberechtigten (n=44, 55,0%) als auch von den gesetzlich betreuten Personen (n=3, 30,0%) als häufigster Grund für eine Nicht-Teilnahme angegeben. Die häufigste Motivation zur Einwilligung in die Teilnahme an einem Forschungsprojekt war die Aussicht, anderen Leidenden durch den Erwerb neuer wissenschaftlicher Erkenntnisse helfen zu können (gesetzliche Betreuer: n =125, 78,1%; gesetzlich betreute Personen: n =10, 66,7%).
Insgesamt lässt sich bei den gesetzlichen Betreuern und den gesetzlich betreuten Personen eine offene Haltung gegenüber der medizinischen Forschung beobachten. Die Mehrheit derjenigen, die bereits über Forschungserfahrung verfügen, wäre bereit, sich erneut an einem Forschungsprojekt zu beteiligen. Die Informationen über den Inhalt von Forschungsprojekten sollten für die gesetzlichen Betreuer und die betreuten Personen gleichermaßen erfolgen, da neben der Einwilligung des gesetzlichen Betreuers, die Einwilligung der betreuten Personen im Sinne eines „informed consent“ eingeholt werden sollte. In diesem Zusammenhang sollten sowohl die möglichen Risiken, als auch der mögliche Nutzen einer Teilnahme dargelegt werden, da nur so eine adäquate Risiko-Nutzen-Abwägung erfolgen kann. Da von einer steigenden Zahl betreuungsbedürftiger Personen auszugehen ist, wird es zunehmend wichtiger, vulnerable Gruppen mit in die medizinische Forschung einzubeziehen. Nur auf diese Weise können bestehende Nachteile vulnerabler Personengruppen in Zukunft abgebaut werden.
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.
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.
Knowledge on differences in the severity and symptoms of infections with the SARS-CoV-2 Omicron variants BA.2 (Pango lineage B.1.529.2) and BA.5 (Pango lineage B.1.529.5) is still scarce. We investigated epidemiological data available from the public health authorities in Mecklenburg-Western Pomerania, Northeast Germany, between April and July 2022 retrospectively. Comparative analyses revealed significant differences between recorded symptoms of BA.2 and BA.5 infected individuals and found strong correlations of associations between symptoms. In particular, the symptoms ‘chills or sweating’, ‘freeze’ and ‘runny nose’ were more frequently reported in BA.2 infections. In contrast, ‘other clinical symptoms’ appeared more frequently in Omicron infections with BA.5. However, the results obtained in this study provide no evidence that BA.5 has a higher pathogenicity or causes a more severe course of infection than BA.2. To our knowledge, this is the first report on clinical differences between the current Omicron variants BA.2 and BA.5 using public health data. Our study highlights the value of timely investigations of data collected by public health authorities to gather detailed information on the clinical presentation of different SARS-CoV-2 subvariants at an early stage.
Discovery of novel eGFR-associated multiple independent signals using a quasi-adaptive method
(2022)
A decreased estimated glomerular filtration rate (eGFR) leading to chronic kidney disease is a significant public health problem. Kidney function is a heritable trait, and recent application of genome-wide association studies (GWAS) successfully identified multiple eGFR-associated genetic loci. To increase statistical power for detecting independent associations in GWAS loci, we improved our recently developed quasi-adaptive method estimating SNP-specific alpha levels for the conditional analysis, and applied it to the GWAS meta-analysis results of eGFR among 783,978 European-ancestry individuals. Among known eGFR loci, we revealed 19 new independent association signals that were subsequently replicated in the United Kingdom Biobank (n = 408,608). These associations have remained undetected by conditional analysis using the established conservative genome-wide significance level of 5 × 10–8. Functional characterization of known index SNPs and novel independent signals using colocalization of conditional eGFR association results and gene expression in cis across 51 human tissues identified two potentially causal genes across kidney tissues: TSPAN33 and TFDP2, and three candidate genes across other tissues: SLC22A2, LRP2, and CDKN1C. These colocalizations were not identified in the original GWAS. By applying our improved quasi-adaptive method, we successfully identified additional genetic variants associated with eGFR. Considering these signals in colocalization analyses can increase the precision of revealing potentially functional genes of GWAS loci.
Background
Numerous wearables are used in a research context to record cardiac activity although their validity and usability has not been fully investigated. The objectives of this study is the cross-model comparison of data quality at different realistic use cases (cognitive and physical tasks). The recording quality is expressed by the ability to accurately detect the QRS complex, the amount of noise in the data, and the quality of RR intervals.
Methods
Five ECG devices (eMotion Faros 360°, Hexoskin Hx1, NeXus-10 MKII, Polar RS800 Multi and SOMNOtouch NIBP) were attached and simultaneously tested in 13 participants. Used test conditions included: measurements during rest, treadmill walking/running, and a cognitive 2-back task. Signal quality was assessed by a new local morphological quality parameter morphSQ which is defined as a weighted peak noise-to-signal ratio on percentage scale. The QRS detection performance was evaluated with eplimited on synchronized data by comparison to ground truth annotations. A modification of the Smith-Waterman algorithm has been used to assess the RR interval quality and to classify incorrect beat annotations. Evaluation metrics includes the positive predictive value, false negative rates, and F1 scores for beat detection performance.
Results
All used devices achieved sufficient signal quality in non-movement conditions. Over all experimental phases, insufficient quality expressed by morphSQ values below 10% was only found in 1.22% of the recorded beats using eMotion Faros 360°whereas the rate was 8.67% with Hexoskin Hx1. Nevertheless, QRS detection performed well across all used devices with positive predictive values between 0.985 and 1.000. False negative rates are ranging between 0.003 and 0.017. eMotion Faros 360°achieved the most stable results among the tested devices with only 5 false positive and 19 misplaced beats across all recordings identified by the Smith-Waterman approach.
Conclusion
Data quality was assessed by two new approaches: analyzing the noise-to-signal ratio using morphSQ, and RR interval quality using Smith-Waterman. Both methods deliver comparable results. However the Smith-Waterman approach allows the direct comparison of RR intervals without the need for signal synchronization whereas morphSQ can be computed locally.
The Apolipoprotein E (APOE) gene polymorphism (rs429358 and rs7412) shows a well-established association with lipid profiles, but its effect on cardiovascular disease is still conflicting. Therefore, we examined the association of different APOE alleles with common carotid artery intima-media thickness (CCA-IMT), carotid plaques, incident myocardial infarction (MI) and stroke. We analyzed data from 3327 participants aged 20–79 years of the population-based Study of Health in Pomerania (SHIP) from Northeast Germany with a median follow-up time of 14.5 years. Linear, logistic, and Cox-regression models were used to assess the associations of the APOE polymorphism with CCA-IMT, carotid plaques, incident MI and stroke, respectively. In our study, the APOE E2 allele was associated with lower CCA-IMT at baseline compared to E3 homozygotes (β: − 0.02 [95% CI − 0.04, − 0.004]). Over the follow-up, 244 MI events and 218 stroke events were observed. APOE E2 and E4 allele were not associated with incident MI (E2 HR: 1.06 [95% CI 0.68, 1.66]; E4 HR: 1.03 [95% CI 0.73, 1.45]) and incident stroke (E2 HR: 0.79 [95% CI 0.48, 1.30]; E4 HR: 0.96 [95% CI 0.66, 1.38]) in any of the models adjusting for potential confounders. However, the positive association between CCA-IMT and incident MI was more pronounced in E2 carriers than E3 homozygotes. Thus, our study suggests that while APOE E2 allele may predispose individuals to lower CCA-IMT, E2 carriers may be more prone to MI than E3 homozygotes as the CCA-IMT increases. APOE E4 allele had no effect on CCA-IMT, plaques, MI or stroke.
Epidemiological data reveal that there is a need for prevention measures specifically targeted at children with low SES. In the German federal state Mecklenburg-Western Pomerania preschools in socially deprived regions can apply for additional funds to support children with developmental risks. Mandatory criteria for obtaining these funds involve an annual assessment of all children using the “Dortmunder Developmental Screening for Preschools (DESK 3–6 R).” This instrument can detect and monitor developmental risks in the domains fine motor skills, gross motor skills, language, cognition, and social development. In this study, we examine the domain “Attention and concentration,” which is included for the 5 to 6-year-old age group, using data from two consecutive survey waves (sw). Research questions: (1) Does the prevalence rate ratio (PRR) improve over time? (2) Is the rate of improvements (developmental risk at sw1, no developmental risk at sw2) higher than the rate of deteriorations (no developmental risk at sw1, developmental risk at sw2)? Prospective cohort analysis (n = 940). The prevalence rate of a developmental risk in this DESK domain decreases over time (PRR = 0.78; p = 0.019). The ratio of the rate of improvements is 8.47 times higher than the rate of deteriorations. The results provide evidence of the effectiveness of targeted intervention measures in preschools focusing on skills that improve attention and concentration. This is significant considering the small-time interval and the categorization method of DESK scores. Nevertheless, over the same time period, the DESK results of some children deteriorated. Therefore, preschools also have to be aware that it is natural for some children to show modest declines in their skills over time. German Clinical Trials Register, ID: DRKS00015134, Registered on 29 October 2018, retrospectively registered.
Objective
Whole-body MRI (wb-MRI) is increasingly used in research and screening but little is known about the effects of incidental findings (IFs) on health service utilisation and costs. Such effects are particularly critical in an observational study. Our principal research question was therefore how participation in a wb-MRI examination with its resemblance to a population-based health screening is associated with outpatient service costs.
Design
Prospective cohort study.
Setting
General population Mecklenburg-Vorpommern, Germany.
Participants
Analyses included 5019 participants of the Study of Health in Pomerania with statutory health insurance data. 2969 took part in a wb-MRI examination in addition to a clinical examination programme that was administered to all participants. MRI non-participants served as a quasi-experimental control group with propensity score weighting to account for baseline differences.Primary and secondary outcome measuresOutpatient costs (total healthcare usage, primary care, specialist care, laboratory tests, imaging) during 24 months after the examination were retrieved from claims data. Two-part models were used to compute treatment effects.
Results
In total, 1366 potentially relevant IFs were disclosed to 948 MRI participants (32% of all participants); most concerned masses and lesions (769 participants, 81%). Costs for outpatient care during the 2-year observation period amounted to an average of €2547 (95% CI 2424 to 2671) for MRI non-participants and to €2839 (95% CI 2741 to 2936) for MRI participants, indicating an increase of €295 (95% CI 134 to 456) per participant which corresponds to 11.6% (95% CI 5.2% to 17.9%). The cost increase was sustained rather than being a short-term spike. Imaging and specialist care related costs were the main contributors to the increase in costs.
Conclusions
Communicated findings from population-based wb-MRI substantially impacted health service utilisation and costs. This introduced bias into the natural course of healthcare utilisation and should be taken care for in any longitudinal analyses.
Background: Patients of geriatrics are often treated by several health care providers at the same time. The spatial, informational, and organizational separation of these health care providers can hinder the effective treatment of these patients.
Objective: This study aimed to develop a regional health information exchange (HIE) system to improve HIE in geriatric treatment. This study also evaluated the usability of the regional HIE system and sought to identify barriers to and facilitators of its implementation.
Methods: The development of the regional HIE system followed the community-based participatory research approach. The primary outcomes were the usability of the regional HIE system, expected implementation barriers and facilitators, and the quality of the developmental process. Data were collected and analyzed using a mixed methods approach.
Results: A total of 3 focus regions were identified, 22 geriatric health care providers participated in the development of the regional HIE system, and 11 workshops were conducted between October 2019 and September 2020. In total, 12 participants responded to a questionnaire. The main results were that the regional HIE system should support the exchange of assessments, diagnoses, medication, assistive device supply, and social information. The regional HIE system was expected to be able to improve the quality and continuity of care. In total, 5 adoption facilitators were identified. The main points were adaptability of the regional HIE system to local needs, availability to different patient groups and treatment documents, web-based design, trust among the users, and computer literacy. A total of 13 barriers to adoption were identified. The main expected barriers to implementation were lack of resources, interoperability issues, computer illiteracy, lack of trust, privacy concerns, and ease-of-use issues.
Conclusions: Participating health care professionals shared similar motivations for developing the regional HIE system, including improved quality of care, reduction of unnecessary examinations, and more effective health care provision. An overly complicated registration process for health care professionals and the patients’ free choice of their health care providers hinder the effectiveness of the regional HIE system, resulting in incomplete patient health information. However, the web-based design of the system bridges interoperability problems that exist owing to the different technical and organizational structures of the health care facilities involved. The regional HIE system is better accepted by health care professionals who are already engaged in an interdisciplinary, geriatric-focused network. This might indicate that pre-existing cross-organizational structures and processes are prerequisites for using HIE systems. The participatory design supports the development of technologies that are adaptable to regional needs. Health care providers are interested in participating in the development of an HIE system, but they often lack the required time, knowledge, and resources.
Background
In non-randomized studies (NRSs) where a continuous outcome variable (e.g., depressive symptoms) is assessed at baseline and follow-up, it is common to observe imbalance of the baseline values between the treatment/exposure group and control group. This may bias the study and consequently a meta-analysis (MA) estimate. These estimates may differ across statistical methods used to deal with this issue. Analysis of individual participant data (IPD) allows standardization of methods across studies. We aimed to identify methods used in published IPD-MAs of NRSs for continuous outcomes, and to compare different methods to account for baseline values of outcome variables in IPD-MA of NRSs using two empirical examples from the Thyroid Studies Collaboration (TSC).
Methods
For the first aim we systematically searched in MEDLINE, EMBASE, and Cochrane from inception to February 2021 to identify published IPD-MAs of NRSs that adjusted for baseline outcome measures in the analysis of continuous outcomes. For the second aim, we applied analysis of covariance (ANCOVA), change score, propensity score and the naïve approach (ignores the baseline outcome data) in IPD-MA from NRSs on the association between subclinical hyperthyroidism and depressive symptoms and renal function. We estimated the study and meta-analytic mean difference (MD) and relative standard error (SE). We used both fixed- and random-effects MA.
Results
Ten of 18 (56%) of the included studies used the change score method, seven (39%) studies used ANCOVA and one the propensity score (5%). The study estimates were similar across the methods in studies in which groups were balanced at baseline with regard to outcome variables but differed in studies with baseline imbalance. In our empirical examples, ANCOVA and change score showed study results on the same direction, not the propensity score. In our applications, ANCOVA provided more precise estimates, both at study and meta-analytical level, in comparison to other methods. Heterogeneity was higher when change score was used as outcome, moderate for ANCOVA and null with the propensity score.
Conclusion
ANCOVA provided the most precise estimates at both study and meta-analytic level and thus seems preferable in the meta-analysis of IPD from non-randomized studies. For the studies that were well-balanced between groups, change score, and ANCOVA performed similarly.
Legal advice and care-effective use of care and case management: limits, risks and need for change
(2022)
Introduction
An important dimension of care and case managers is to support geriatric patients in obtaining social services in medical, nursing, therapeutic and social fields. To this, they advise and represent their patients.
Methods
The documentation of patient contacts with case managers of a network of physicians was evaluated. In particular, activities involving legal advice were analysed in detail, compared with the current legal situation in Germany and evaluated. In addition, qualitative expert interviews were conducted. The content and the legal requirements of legal services law were determined by applying legal interpretation methods (esp. wording, telos, systematics). The results of the evaluation of the documentation were compared with legal requirements.
Results
Care and case management touches activities in some fields of action without having a legal basis in legal services law. This leads to the fact that these services may not be provided and to - uninsured and uninsurable - liability risks.
Discussion
With the introduction of care and case management into standard care, both social law and the Legal Services Act must be adapted to enable the legally compliant use of care and case managers. Otherwise, certain services that are useful for the care of patients may not be provided.
Background
Although chronic kidney disease (CKD) is highly prevalent in the general population, little research has been conducted on CKD management in ambulatory care.
Objective was to assess management and quality of care by evaluating CKD coding in ambulatory care, patient diagnosis awareness, frequency of monitoring and whether appropriate patients are referred to nephrology.
Methods
Clinical data from the population-based cohort Study of Health in Pomerania (SHIP-START) were matched with claims data of the Association of Statutory Health Insurance Physicians. Quality of care was evaluated according international and German recommendations.
Results
Data from 1778 participants (56% female, mean age 59 years) were analysed. 10% had eGFR < 60 ml/min/1.73m2 (mean age 74 years), 15% had albuminuria. 21% had CKD as defined by KDIGO. 20% of these were coded and 7% self-reported having CKD. Coding increased with GFR stage (G3a 20%, G3b 61%, G4 75%, G5 100%). Serum creatinine and urinary dip stick testing were billed in the majority of all participants regardless of renal function. Testing frequency partially surpassed recommendations. Nephrology consultation was billed in few cases with stage G3b-G4.
Conclusion
CKD coding increased with stage and was performed reliably in stages ≥ G4, while CKD awareness was low. Adherence to monitoring and referral criteria varied, depending on the applicability of monitoring criteria. For assessing quality of care, consent on monitoring, patient education, referral criteria and coordination of care needs to be established, accounting for patient related factors, including age and comorbidity.
Trial registration
This study was prospectively registered as DRKS00009812 in the German Clinical Trials Register (DRKS).
Multivariate analysis of independent determinants of ADL/IADL and quality of life in the elderly
(2022)
Background
This study evaluated the determinants of disability and quality of life in elderly people who participated at the multi-centred RubiN project (Regional ununterbrochen betreut im Netz) in Germany.
Methods
Baseline data of the subjects aged 70 years and older of the RubiN project were used and only subjects with complete data sets were considered for the ensuing analysis (complete case analysis (CCA)).
Disability was examined using the concepts of ADL (activities of daily living) and IADL (instrumental activities of daily living). Subjects exhibiting one or more deficiencies in ADL respectively IADL were considered as ADL respectively IADL disabled. Quality of life was assessed using the WHOQOL-BREF and the WHOQOL-OLD. Applying multivariate analysis, sociodemographic factors, psychosocial characteristics as well as the functional, nutritional and cognitive status were explored as potential determinants of disability and quality of life in the elderly.
Results
One thousand three hundred seventy-five subjects from the RubiN project exhibited data completeness regarding baseline data. ADL and IADL disability were both associated with the respective other construct of disability, sex, a reduced cognitive and functional status as well as domains of the WHOQOL-BREF. Furthermore, ADL disability was related to social participation, while IADL disability was linked to age, education and social support. Sex, ADL and IADL disability, income, social support and social participation as well as the functional status were predictors of the domain ‘Physical Health’ (WHOQOL-BREF). The facet ‘Social Participation’ (WHOQOL-OLD) was affected by both ADL and IADL disability, income, social participation, the nutritional and also the functional status.
Conclusions
Several potential determinants of disability and quality of life were identified and confirmed in this study. Attention should be drawn to prevention schemes as many of these determinants appear to be at least partly modifiable.
Background: A large body of research indicates that the cognitions individuals have
about their own age and aging, so called self-perceptions of aging (SPA), predict health and
wellbeing in later life. However, much less is known about associations of SPA with
developmental correlates such as personality. Some initial studies have found cross-sectional
and longitudinal associations of the Big Five traits (openness to experience,
conscientiousness, extraversion, agreeableness, and neuroticism) with SPA. Building on these
findings, this thesis aimed at advancing knowledge on associations of personality with SPA.
To this end, cross-sectional associations of the meta-traits of agency, i.e., a focus on the self,
and communion, i.e., a focus on others, with SPA were examined in study 1, and longitudinal
associations of agentic and communal personal values with SPA were examined in study 2.
Study 3 aimed at expanding findings of previous studies on associations of SPA with selfreported
physical function to an objective indicator of physical function, namely, gait pattern.
In all studies, SPA were treated as a multidimensional construct comprising gains and losses.
Methods: Study 1 was based on data of 154 adults aged 75 and older that were
recruited in hospital. Data was collected one month after recruitment. In regression analyses,
associations of agentic and communal traits with SPA beyond health were examined. Study 2
was based on data of 6,089 adults aged 40 and older enrolled in the German Ageing Survey
(DEAS). Multiple regression analyses were used to test whether personal value priority
predicted change in SPA over three years beyond age stereotypes. For study 3, latent profile
analysis was employed to detect gait patterns based on data of 150 adults aged 70 and older
collected via an automated walkway at participants’ regular speed and individual maximum
speed. In a next step, associations of SPA with gait patterns beyond personality traits were
investigated in binary logistic regressions.
Results: Agentic and communal personality traits were associated with gain-, but not
loss-related SPA when controlling for health (study 1). In study 2, the value priority of
openness to change (self-direction, stimulation) predicted more gain-related SPA three years
later, while the value priority of conservation (tradition, security) was negatively associated
with gain-related SPA. The value priority of self-enhancement (achievement, power) was
associated with more loss-related SPA three years later. Finally, the value priority of selftranscendence
(universalism, benevolence), i.e. a concern for the well-being of others, was
associated with more gain- and less loss-related SPA at follow-up. In study 3, latent profile
analyses distinguished two groups with different gait patterns in both gait speed conditions.
One group exhibited a slower and less well-coordinated gait pattern, which reflected
functional limitations. The other group exhibited a faster and well-coordinated gait pattern,
which reflected better physical function. More loss-, but not gain-related SPA were associated
with higher likelihood to exhibit a functionally limited gait pattern at regular speed.
Conversely, gain- but not loss-related SPA were associated with higher likelihood to exhibit a
fit gait pattern at individual maximum speed.
Conclusion: Results of this thesis have three main implications for research on SPA.
First, agency and communion may constitute useful dimensions for further investigating SPA
domains, as both were associated with SPA in study 1. Second, findings of study 2 point to
the role of motivation for SPA that needs to be further explored. Third, findings of study 3
indicate that SPA are not only associated with self-reported, but also objectively measured
physical function, which stresses the importance of SPA for health in later life. As a practical
implication, the findings presented here suggest that interventions on SPA should consider
participants’ personality, both on the level of traits and values.
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).
The structure and content of the training phase following completion of medical school, referred to in most countries as postgraduate medical training, varies between countries. The purpose of this article is to give national and international readers an overview of the organisation and structure of postgraduate medical training in Germany.
The content and duration of postgraduate training in Germany are stipulated by state medical boards, officially termed associations (Landesärztekammer). In a periodically updated decree, the federal German medical association (Bundesärztekammer) provides a template for postgraduate medical training structure (Musterweiterbildungsordnung), which is adapted by the state medical associations. Admission to postgraduate medical training in Germany takes place by way of open, free-market selection. Based on the traditional assumption that junior doctors acquire all necessary clinical skills “on the job”, formal education in the form of seminars, lectures, or preorganised, detailed rotation plans through various specialties or wards is largely absent. Requirements for postgraduate medical training focus on the fulfilment of broad categories of rotations rather than specific content or gaining competencies. With few exceptions, no structured educational programs with curricular learning objectives exist. Limited funding impedes program development and expansion. Junior doctors bear the primary organisational responsibility in their training, which often results in extended training times and dissatisfaction. Structured training programs which prioritise skill-building and formal education are needed to support junior doctors and ensure their competence in primary and specialty care.
This is the first study to analyze the association of accelerometer-measured patterns of habitual physical activity (PA) and sedentary behavior (SB) with serum BDNF in individuals with coronary heart disease. A total of 30 individuals (M = 69.5 years; 80% men) participated in this pre-post study that aimed to test a multi-behavioral intervention. All participants underwent standardized measurement of anthropometric variables, blood collection, self-administered survey, and accelerometer-based measurement of PA and SB over seven days. Serum BDNF concentrations were measured using enzyme-linked immunosorbent assay kit. We applied separate multiple linear regression analysis to estimate the associations of baseline SB pattern measures, light and moderate-to-vigorous PA with serum BDNF (n = 29). Participants spent 508.7 ± 76.5 min/d in SB, 258.5 ± 71.2 min/d in light PA, and 21.2 ± 15.2 min/d in moderate-to-vigorous PA. Per day, individuals had 15.5 ± 3.2 numbers of 10-to-30 min bouts of SB (average length: 22.2 ± 2.1 min) and 3.4 ± 1.2 numbers of > 30 min bouts of SB (average length: 43.8 ± 2.4 min). Regression analysis revealed no significant associations between any of the accelerometer-based measures and serum BDNF. The findings of this study did not reveal an association of accelerometer-measured PA and SB pattern variables with serum BDNF in individuals with coronary heart disease. In addition, our data revealed a considerable variation of PA and SB which should be considered in future studies.
Data quality assessments (DQA) are necessary to ensure valid research results. Despite the growing availability of tools of relevance for DQA in the R language, a systematic comparison of their functionalities is missing. Therefore, we review R packages related to data quality (DQ) and assess their scope against a DQ framework for observational health studies. Based on a systematic search, we screened more than 140 R packages related to DQA in the Comprehensive R Archive Network. From these, we selected packages which target at least three of the four DQ dimensions (integrity, completeness, consistency, accuracy) in a reference framework. We evaluated the resulting 27 packages for general features (e.g., usability, metadata handling, output types, descriptive statistics) and the possible assessment’s breadth. To facilitate comparisons, we applied all packages to a publicly available dataset from a cohort study. We found that the packages’ scope varies considerably regarding functionalities and usability. Only three packages follow a DQ concept, and some offer an extensive rule-based issue analysis. However, the reference framework does not include a few implemented functionalities, and it should be broadened accordingly. Improved use of metadata to empower DQA and user-friendliness enhancement, such as GUIs and reports that grade the severity of DQ issues, stand out as the main directions for future developments.
Background
Clinical practice guidelines recommend specialist referral according to different criteria. The aim was to assess recommended and observed referral rate and health care expenditure according to recommendations from:
• Kidney Disease Improving Global Outcomes (KDIGO,2012)
• National Institute for Health and Care Excellence (NICE,2014)
• German Society of Nephrology/German Society of Internal Medicine (DGfN/DGIM,2015)
• German College of General Practitioners and Family Physicians (DEGAM,2019)
• Kidney failure risk equation (NICE,2021)
Methods
Data of the population-based cohort Study of Health in Pomerania were matched with claims data. Proportion of subjects meeting referral criteria and corresponding health care expenditures were calculated and projected to the population of Mecklenburg-Vorpommern.
Results
Data from 1927 subjects were analysed. Overall proportion of subjects meeting referral criteria ranged from 4.9% (DEGAM) to 8.3% (DGfN/DGIM). The majority of patients eligible for referral were ≥ 60 years. In subjects older than 60 years, differences were even more pronounced, and rates ranged from 9.7% (DEGAM) to 16.5% (DGfN/DGIM). Estimated population level costs varied between €1,432,440 (DEGAM) and €2,386,186 (DGfN/DGIM). From 190 patients with eGFR < 60 ml/min, 15 had a risk of end stage renal disease > 5% within the next 5 years.
Conclusions
Applying different referral criteria results in different referral rates and costs. Referral rates exceed actually observed consultation rates. Criteria need to be evaluated in terms of available workforce, resources and regarding over- and underutilization of nephrology services.
Background
Since the onset of the COVID-19 pandemic, children have been mentally and physically burdened, particularly due to school closures, with an associated loss of learning. Therefore, efficient testing strategies with high sensitivity are necessary to keep schools open. Apart from individual rapid antigen testing, various methods have been investigated, such as PCR-based pool-testing of nasopharyngeal swabs, gargle, or saliva samples. To date, previous validation studies have found the PCR-based saliva swab pool testing method to be an effective screening method, however, the acceptability and feasibility of a widespread implementation in the school-setting among stakeholders has not been comprehensively evaluated.
Methods
In this pilot study, SARS-CoV-2 saliva swab pool testing of up to 15 swabs per pool was conducted in ten primary and special schools in Mecklenburg-Western Pomerania, Germany, over a period of one month. Thereafter, parents, teachers and school principals of the participating schools as well as the participating laboratories were surveyed about the feasibility and acceptability of this method, its large-scale implementation and challenges. Data were analyzed quantitatively and qualitatively.
Results
During the study period, 1,630 saliva swab pools were analyzed, of which 22 tested SARS-CoV-2 positive (1.3%). A total of N = 315 participants took part in the survey. Across all groups, the saliva swab pool testing method was perceived as more child-friendly (>87%), convenient (>82%), and easier (>81%) compared to rapid antigen testing by an anterior nasal swab. Over 80% of all participants favored widespread, regular use of the saliva swab method.
Conclusion
In school settings in particular, a high acceptability of the test method is crucial for a successful SARS-CoV-2 surveillance strategy. All respondents clearly preferred the saliva swab method, which can be used safely without complications in children six years of age and older. Hurdles and suggestions for improvement of an area-wide implementation were outlined.
Background
Data collected during routine health care and ensuing analytical results bear the potential to provide valuable information to improve the overall health care of patients. However, little is known about how patients prefer to be informed about the possible usage of their routine data and/or biosamples for research purposes before reaching a consent decision. Specifically, we investigated the setting, the timing and the responsible staff for the information and consent process.
Methods
We performed a quasi-randomized controlled trial and compared the method by which patients were informed either in the patient admission area following patient admission by the same staff member (Group A) or in a separate room by another staff member (Group B). The consent decision was hypothetical in nature. Additionally, we evaluated if there was the need for additional time after the information session and before taking the consent decision. Data were collected during a structured interview based on questionnaires where participants reflected on the information and consent process they went through.
Results
Questionnaire data were obtained from 157 participants in Group A and 106 participants in Group B. Overall, participants in both groups were satisfied with their experienced process and with the way information was provided. They reported that their (hypothetical) consent decision was freely made. Approximately half of the interested participants in Group B did not show up in the separate room, while all interested participants in Group A could be informed about the secondary use of their routine data and left-over samples. No participants, except for one in Group B, wanted to take extra time for their consent decision. The hypothetical consent rate for both routine data and left-over samples was very high in both groups.
Conclusions
The willingness to support medical research by allowing the use of routine data and left-over samples seems to be widespread among patients. Information concerning this secondary data use may be given by trained administrative staff immediately following patient admission. Patients mainly prefer making a consent decision directly after information is provided and discussed. Furthermore, less patients are informed when the process is organized in a separate room.
Background
Missing data are ubiquitous in randomised controlled trials. Although sensitivity analyses for different missing data mechanisms (missing at random vs. missing not at random) are widely recommended, they are rarely conducted in practice. The aim of the present study was to demonstrate sensitivity analyses for different assumptions regarding the missing data mechanism for randomised controlled trials using latent growth modelling (LGM).
Methods
Data from a randomised controlled brief alcohol intervention trial was used. The sample included 1646 adults (56% female; mean age = 31.0 years) from the general population who had received up to three individualized alcohol feedback letters or assessment-only. Follow-up interviews were conducted after 12 and 36 months via telephone. The main outcome for the analysis was change in alcohol use over time. A three-step LGM approach was used. First, evidence about the process that generated the missing data was accumulated by analysing the extent of missing values in both study conditions, missing data patterns, and baseline variables that predicted participation in the two follow-up assessments using logistic regression. Second, growth models were calculated to analyse intervention effects over time. These models assumed that data were missing at random and applied full-information maximum likelihood estimation. Third, the findings were safeguarded by incorporating model components to account for the possibility that data were missing not at random. For that purpose, Diggle-Kenward selection, Wu-Carroll shared parameter and pattern mixture models were implemented.
Results
Although the true data generating process remained unknown, the evidence was unequivocal: both the intervention and control group reduced their alcohol use over time, but no significant group differences emerged. There was no clear evidence for intervention efficacy, neither in the growth models that assumed the missing data to be at random nor those that assumed the missing data to be not at random.
Conclusion
The illustrated approach allows the assessment of how sensitive conclusions about the efficacy of an intervention are to different assumptions regarding the missing data mechanism. For researchers familiar with LGM, it is a valuable statistical supplement to safeguard their findings against the possibility of nonignorable missingness.
Severity of alcohol dependence and mortality after 20 years in an adult general population sample
(2022)
Objectives
To estimate mortality on grounds of the severity of alcohol dependence which has been assessed by two approaches: the frequency of alcohol dependence symptoms (FADS) and the number of alcohol dependence criteria (NADC).
Methods
A random sample of adult community residents in northern Germany at age 18 to 64 had been interviewed in 1996. Among 4075 study participants at baseline, for 4028 vital status was ascertained 20 years later. The FADS was assessed by the Severity of Alcohol Dependence Scale among the 780 study participants who had one or more symptoms of alcohol dependence or abuse and vital status information. The NADC was estimated by the Munich Composite International Diagnostic Interview among 4028 study participants with vital status information. Cox proportional hazard models were used.
Results
The age-adjusted hazard ratio for the FADS (value range: 0–79) was 1.02 (95% confidence interval, CI: 1.016–1.028), for the NADC (value range: 0–7) it was 1.25 (CI: 1.19–1.32).
Conclusions
The FADS and NADC predicted time to death in a dose-dependent manner in this adult general population sample.
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
Multiple Sclerosis is an autoimmune inflammatory disease of the central nervous system that often leads to premature incapacity for work. Therefore, the MSnetWork project implements a new form of care and pursues the goal of maintaining or even improving the state of health of MS patients and having a positive influence on their ability to work as well as their participation in social life. A network of neurologists, occupational health and rehabilitation physicians, psychologists, and social insurance suppliers provide patients with targeted services that have not previously been part of standard care. According to the patient’s needs treatment options will be identified and initiated.
Methods
The MSnetWork study is designed as a multicenter randomized controlled trial, with two parallel groups (randomization at the patient level with 1:1 allocation ratio, planned N = 950, duration of study participation 24 months). After 12 months, the patients in the control group will also receive the interventions. The primary outcome is the number of sick leave days. Secondary outcomes are health-related quality of life, physical, affective and cognitive status, fatigue, costs of incapacity to work, treatment costs, out-of-pocket costs, self-efficacy, and patient satisfaction with therapy.
Intervention effects are analyzed by a parallel-group comparison between the intervention and the control group. Furthermore, the long-term effects within the intervention group will be observed and a pre-post comparison of the control group, before and after receiving the intervention in MSnetWork, will be performed.
Discussion
Due to the multiple approaches to patient-centered, multidisciplinary MS care, MSnetWork can be considered a complex intervention. The study design and linkage of comprehensive, patient-specific primary and secondary data in an outpatient setting enable the evaluation of this complex intervention, both on a qualitative and quantitative level. The basic assumption is a positive effect on the prevention or reduction of incapacity for work as well as on the patients’ quality of life. If the project proves to be a success, MSnetWork could be adapted for the treatment of other chronic diseases with an impact on the ability to work and quality of life.
Trial registration
The trial MSnetWork has been retrospectively registered in the German Clinical Trials Register (DRKS) since 08.07.2022 with the ID DRKS00025451.
Teaching is amongst the six professions with the highest stress levels and lowest job satisfaction, leading to a high turnover rate and teacher shortages. During the pandemic, teachers and school principals were confronted with new regulations and teaching methods. This study aims to examine post-pandemic stress levels, as well as resilience factors to proactively cope with stress and thoughts of leaving the profession among teachers and school principals. We used a cross-sectional online survey. The validated instruments Perceived Stress Scale (PSS-10) and Proactive Coping Subscale (PCI) were used. We included 471 teachers and 113 school principals in the analysis. Overall, respondents had a moderate stress level. During the pandemic, every fourth teacher (27.2%) and every third principal (32.7%) had serious thoughts of leaving the profession. More perceived helplessness (OR = 1.2, p < 0.001), less self-efficacy (OR = 0.8, p = 0.002), and poorer coping skills (OR = 0.96, p = 0.044) were associated with a higher likelihood of thoughts of leaving the profession for teachers, whereas for school principals, only higher perceived helplessness (OR = 1.2, p = 0.008) contributed significantly. To prevent further teacher attrition, teachers and school principals need support to decrease stress and increase their ability to cope.
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.
Introduction: The aim of this study was to test whether brief alcohol interventions at general hospitals work equally well for males and females and across age-groups.
Methods: The current study includes a reanalysis of data reported in the PECO study (testing delivery channels of individualized motivationally tailored alcohol interventions among general hospital patients: in PErson vs. COmputer-based) and is therefore of exploratory nature. At-risk drinking general hospital patients aged 18–64 years (N = 961) were randomized to in-person counseling, computer-generated individualized feedback letters, or assessment only. Both interventions were delivered on the ward and 1 and 3 months later. Follow-ups were conducted at months 6, 12, 18, and 24. The outcome was grams of alcohol/day. Study group × sex and study group × age interactions were tested as predictors of change in grams of alcohol/day over 24 months in latent growth models. If rescaled likelihood ratio tests indicated improved model fit due to the inclusion of interactions, moderator level-specific net changes were calculated.
Results: Model fit was not significantly improved due to the inclusion of interaction terms between study group and sex (χ2[6] = 5.9, p = 0.439) or age (χ2[6] = 5.5, p = 0.485).
Discussion: Both in-person counseling and computer-generated feedback letters may work equally well among males and females as well as among different age-groups. Therefore, widespread delivery of brief alcohol interventions at general hospitals may be unlikely to widen sex and age inequalities in alcohol-related harm.
Background
Few studies have assessed trajectories of alcohol use in the general population, and even fewer studies have assessed the impact of brief intervention on the trajectories. Especially for low-risk drinkers, it is unclear what trajectories occur, whether they benefit from intervention, and if so, when and how long. The aims were first, to identify alcohol use trajectories among at-risk and among low-risk drinkers, second, to explore potential effects of brief alcohol intervention and, third, to identify predictors of trajectories.
Methods
Adults aged 18-64 years were screened for alcohol use at a municipal registration office. Those with alcohol use in the past 12 months (N = 1646; participation rate: 67%) were randomized to assessment plus computer-generated individualized feedback letters or assessment only. Outcome was drinks/week assessed at months 3, 6, 12, and 36. Alcohol risk group (at-risk/low-risk) was determined using the Alcohol Use Disorders Identification Test–Consumption. Latent class growth models were estimated to identify alcohol use trajectories among each alcohol risk group. Sex, age, school education, employment status, self-reported health, and smoking status were tested as predictors.
Results
For at-risk drinkers, a light-stable class (46%), a medium-stable class (46%), and a high-decreasing class (8%) emerged. The light-stable class tended to benefit from intervention after 3 years (Incidence Rate Ratio, IRR=1.96; 95% Confidence Interval, CI: 1.14–3.37). Male sex, higher age, more years of school, and current smoking decreased the probability of belonging to the light-stable class (p-values<0.05). For low-risk drinkers, a very light-slightly increasing class (72%) and a light-increasing class (28%) emerged. The very light-slightly increasing class tended to benefit from intervention after 6 months (IRR=1.60; 95% CI: 1.12–2.28). Male sex and more years of school increased the probability of belonging to the light-increasing class (p-value < 0.05).
Conclusion
Most at-risk drinkers did not change, whereas the majority of low-risk drinkers increased alcohol use. There may be effects of alcohol feedback, with greater long-term benefits among persons with low drinking amounts. Our findings may help to identify refinements in the development of individualized interventions to reduce alcohol use.
Aims
To examine whether inactive nurses are willing to return to nursing during the COVID-19 pandemic, the reasons for or against their decision and further, possibly relevant factors.
Design
Cross-sectional online survey.
Methods
We developed a questionnaire, addressing registration, professional experiences, anticipations, and internal and external factors that might affect the decision of inactive nurses to return to nursing during the pandemic. Between 27 April and 15 June 2020, we recruited participants in Germany via social networks, organizations and institutions and asked them to forward the link to wherever other inactive nurses might be reached.
Results
Three hundred and thirty-two participants (73% female) could be included in the analysis. The majority of the participants (n = 262, 79%) were general nurses. The main reason for registering was ‘want to do my bit to manage the crisis’ (n = 73, 22.8%). More than two thirds of the participants (n = 230, 69%) were not or not yet registered. One hundred and twelve (49%) out of 220 participants, who gave reasons why they did not register, selected they ‘could not see a necessity at that time’. The few inactive nurses who were deployed reported a variety of experiences.
Conclusions
Different factors influence the nurses’ decision to register or not. A critical factor for their decision was previous experiences that had made them leave the job and prevented a return—even for a limited time in a special situation.
Impact
From the responses of the participants in this study, it can be deduced that: negative experiences made while working in nursing influence the willingness to volunteer for a deployment; only one-third of the inactive nurses would be willing to return to the nursing profession to help manage the Corona pandemic; policymakers and nursing leaders should not rely on the availability of inactive nurses in a crisis.
In 2009, the Democratic Republic of Congo (DRC) started its journey towards achieving Universal Health Coverage (UHC). This study examines the evolution of financial risk protection and health outcomes indicators in the context of the commitment of DRC to UHC. To measure the effects of such a commitment on financial risk protection and health outcomes indicators, we analyse whether changes have occurred over the last two decades and, if applicable, when these changes happened. Using five variables as indicators for the measurement of the financial risk protection component, there as well retained three indicators to measure health outcomes. To identify time-related effects, we applied the parametric approach of breakpoint regression to detect whether the UHC journey has brought change and when exactly the change has occurred.
Although there is a slight improvement in the financial risk protection indicators, we found that the adopted strategies have fostered access to healthcare for the wealthiest quantile of the population while neglecting the majority of the poorest. The government did not thrive persistently over the past decade to meet its commitment to allocate adequate funds to health expenditures. In addition, the support from donors appears to be unstable, unpredictable and unsustainable. We found a slight improvement in health outcomes attributable to direct investment in building health centres by the private sector and international organizations. Overall, our findings reveal that the prevention of catastrophic health expenditure is still not sufficiently prioritized by the country, and mostly for the majority of the poorest. Therefore, our work suggests that DRC’s UHC journey has slightly contributed to improve the financial risk protection and health outcomes indicators but much effort should be undertaken.
Background
In the German health care system, parents with an acutely ill child can visit an emergency room (ER) 24 hours a day, seven days a week. At the ER, the patient receives a medical consultation. Many parents use these facilities as they do not know how urgently their child requires medical attention. In recent years, paediatric departments in smaller hospitals have been closed, particularly in rural regions. As a result of this, the distances that patients must travel to paediatric care facilities in these regions are increasing, causing more children to visit an ER for adults. However, paediatric expertise is often required in order to assess how quickly the patient requires treatment and select an adequate treatment. This decision is made by a doctor in German ERs. We have examined whether remote paediatricians can perform a standardised urgency assessment (triage) using a video conferencing system.
Methods
Only acutely ill patients who were brought to a paediatric emergency room (paedER) by their parents or carers, without prior medical consultation, have been included in this study. First, an on-site paediatrician assessed the urgency of each case using a standardised triage. In order to do this, the Paediatric Canadian Triage and Acuity Scale (PaedCTAS) was translated into German and adapted for use in a standardised IT-based data collection tool. After the initial on-site triage, a telemedicine paediatrician, based in a different hospital, repeated the triage using a video conferencing system. Both paediatricians used the same triage procedure. The primary outcome was the degree of concordance and interobserver agreement, measured using Cohen’s kappa, between the two paediatricians. We have also included patient and assessor demographics.
Results
A total of 266 patients were included in the study. Of these, 227 cases were eligible for the concordance analysis. In n = 154 cases (68%), there was concordance between the on-site paediatrician’s and telemedicine paediatrician’s urgency assessments. In n = 50 cases (22%), the telemedicine paediatrician rated the urgency of the patient’s condition higher (overtriage); in 23 cases (10%), the assessment indicated a lower urgency (undertriage). Nineteen medical doctors were included in the study, mostly trained paediatric specialists. Some of them acted as an on-site doctor and telemedicine doctor. Cohen’s weighted kappa was 0.64 (95% CI: 0.49–0.79), indicating a substantial agreement between the specialists.
Conclusions
Telemedical triage can assist in providing acute paediatric care in regions with a low density of paediatric care facilities. The next steps are further developing the triage tool and implementing telemedicine urgency assessment in a larger network of hospitals in order to improve the integration of telemedicine into hospitals’ organisational processes. The processes should include intensive training for the doctors involved in telemedical triage.
Metabolites are intermediates or end products of biochemical processes involved in both health and disease. Here, we take advantage of the well-characterized Cooperative Health Research in South Tyrol (CHRIS) study to perform an exome-wide association study (ExWAS) on absolute concentrations of 175 metabolites in 3294 individuals. To increase power, we imputed the identified variants into an additional 2211 genotyped individuals of CHRIS. In the resulting dataset of 5505 individuals, we identified 85 single-variant genetic associations, of which 39 have not been reported previously. Fifteen associations emerged at ten variants with >5-fold enrichment in CHRIS compared to non-Finnish Europeans reported in the gnomAD database. For example, the CHRIS-enriched ETFDH stop gain variant p.Trp286Ter (rs1235904433-hexanoylcarnitine) and the MCCC2 stop lost variant p.Ter564GlnextTer3 (rs751970792-carnitine) have been found in patients with glutaric acidemia type II and 3-methylcrotonylglycinuria, respectively, but the loci have not been associated with the respective metabolites in a genome-wide association study (GWAS) previously. We further identified three gene-trait associations, where multiple rare variants contribute to the signal. These results not only provide further evidence for previously described associations, but also describe novel genes and mechanisms for diseases and disease-related traits.