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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.
Background: Alcohol consumption accounts for a high burden of disease. The general population of West Pomerania has been characterized as a population at risk with a high prevalence of behavioural risk factors such as alcohol risk drinking. This is reflected by the high proportion of patients being admitted to general hospitals due to alcohol-attributable diseases. The aims of the present dissertation were (a) to analyze dose-response relations between volume of alcohol drinking and the risk of diseases with different alcohol-attributable fractions (AAF) in general hospital inpatients (study 1); (b) to assess motivation to change drinking behaviour and motivation to seek help for alcohol problems during their hospital stay as well as changes in motivation to change drinking behaviour, motivation to seek help and changes in daily alcohol consumption across time according to diseases with different AAFs (study 2); and (c) to investigate the association of fatty liver disease (FLD) with blood pressure and hypertension in a general population sample and to test for the specific contribution of alcohol consumption to this association (study 3). Methods: For studies 1 and 2, data from 'Early Intervention at General Hospitals', a randomized controlled trial to test the effectiveness of brief intervention for alcohol problem drinking in general hospitals, were used. Study 1 comprised data from 846 inpatients, study 2 comprised data from 294 inpatients aged 18 to 64 years with alcohol problem drinking and alcohol-attributable diseases from four general hospitals in West Pomerania. Hospital diagnoses were classified according to their AAF: (1) diseases wholly attributable to alcohol consumption by definition (AAF=1), (2) diseases partially attributable to alcohol consumption (AAF<1), and (3) diseases with no relation to alcohol consumption or where alcohol consumption has been found to be a protective factor (AAF=0). Study 3 encompassed data from the 'Study of Health in Pomerania', a general population sample of 3191 adults aged 20-79 years. FLD was defined using ultrasound in combination with increased serum alanine aminotransferase levels. Results: Analyses showed that 46.8% of the general hospital inpatients had a disease attributable to alcohol consumption. There was a dose-response relationship between volume of alcohol drinking and the risk of diseases with different AAFs. Inpatients consuming >120 g and inpatients consuming 61-120 g of pure alcohol per day revealed significantly higher odds for diseases with AAF=1 compared to inpatients consuming 31-60 g of pure alcohol per day with odds ratios (OR) of 6.3 (95% CI 3.6-11.3) and 2.9 (95% CI 1.6-5.1), respectively. Regarding diseases with AAF<1, inpatients consuming >120 g of pure alcohol per day had significantly higher odds compared to inpatients consuming 31-60 g of pure alcohol per day (OR 2.0, CI 1.2-3.4). Analyses on motivation to change drinking behaviour and on motivation to seek help at hospitalization revealed that motivation to change drinking behaviour was higher among inpatients with alcohol-attributable diseases than among inpatients without alcohol-attributable diseases (p<.001). Among inpatients with AAF=1, motivation to seek help was higher than among inpatients with AAF<1 and AAF=0 (p<.001). While motivation to change drinking behaviour remained stable within one year after hospitalization in all three AAF groups, motivation to seek help decreased in this time period. The volume of alcohol consumed decreased in all three AAF groups within one year after hospitalization. Data from the general population study revealed that FLD was associated with blood pressure and hypertension at baseline and at five-year examination follow-up. For example, the chance of hypertension at both time points was threefold higher in individuals with FLD (OR 2.8, CI 1.3-6.2; OR 3.1, CI 1.7-5.8, respectively) compared to individuals without FLD. Analyses further revealed that the association of FLD with blood pressure and hypertension was independent of alcohol consumption. Conclusion: The results of the present dissertation provide relevant implications for public health. In view of the high proportion of general hospital inpatients with alcohol-attributable diseases, a screening procedure for problem drinking is needed. Furthermore, appropriate interventions considering the inpatient’s motivational level have to be implemented. The concept of AAFs to classify disease conditions according to their causal relationship with alcohol consumption might be a tool to detect inpatients with problem drinking. The results regarding FLD and its association with blood pressure and hypertension demonstrate that it is important to pay attention to alcohol-attributable diseases in the general population and that alcohol-attributable diseases are associated with subsequent serious sequelae. The results of the present work further indicate that the concept to distinguish between alcoholic and non-alcoholic origin of FLD might be obsolete and should be replaced by a concept that regards FLD as a multifactorial disease condition.
Previous studies on the antimicrobial activity of cold atmospheric pressure argon plasma showed varying effects against mecA<sup>+</sup> or mecA<sup>-</sup>Staphylococcus aureus strains. This observation may have important clinical and epidemiological implications. Here, the antibacterial activity of argon plasma was investigated against 78 genetically different S. aureus strains, stratified by mecA, luk-P, agr1-4, or the cell wall capsule polysaccharide types 5 and 8. kINPen09® served as the plasma source for all experiments. On agar plates, mecA<sup>+</sup>luk-P<sup>-</sup>S. aureus strains showed a decreased susceptibility against plasma compared to other S. aureus strains. This study underlines the high complexity of microbial defence against antimicrobial treatment and confirms a previously reported strain-dependent susceptibility of S. aureus to plasma treatment.
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.
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.
Background: Fatigue, dyspnea, and lack of energy and concentration are commonly interpreted as indicative of symptomatic anemia and may thus play a role in diagnostic and therapeutic decisions. Objective: To investigate the association between symptoms commonly attributed to anemia and the actual presence of anemia. Methods: Data from two independent cohorts of the Study of Health in Pomerania (SHIP) were analyzed. Interview data, laboratory data, and physical examination were individually linked with claims data from the Association of Statutory Health Insurance Physicians. A complete case analysis using logistic regression models was performed to evaluate the association of anemia with symptoms commonly attributed to anemia. The models were adjusted for confounders such as depression, medication, insomnia, and other medical conditions. Results: A total of 5979 participants (53% female, median age 55) were included in the analysis. Of those, 30% reported fatigue, 16% reported lack of energy, 16% reported lack of concentration, and 29% reported dyspnea and/or weakness. Anemia was prevalent in about 6% (379). The symptoms were more prevalent in participants with anemia. However, participants with anemia were older and had a poorer health status. There was no association in multivariate logistic regression models between the symptoms fatigue, lack of concentration, dyspnea, and/or weakness and anemia. Anemia was associated (OR: 1.45; 95% CI: 1.13–1.86) with lack of energy in the multivariate analysis. Other factors such as depression, insomnia, and medication were more strongly associated with the symptoms. Conclusion: The clinical symptoms commonly attributed to anemia are unspecific and highly prevalent both in non-anemic and anemic persons. Even in the presence of anemia, other diagnoses should be considered as causes such as depression, heart failure, asthma, and COPD, which are more closely associated with the symptoms. Further diagnostic research is warranted to explore the association of symptoms in different subgroups and settings in order to help clinical decision making.
Background
Long periods of uninterrupted sitting, i.e., sedentary bouts, and their relationship with adverse health outcomes have moved into focus of public health recommendations. However, evidence on associations between sedentary bouts and adiposity markers is limited. Our aim was to investigate associations of the daily number of sedentary bouts with waist circumference (WC) and body mass index (BMI) in a sample of middle-aged to older adults.
Methods
In this cross-sectional study, data were collected from three different studies that took place in the area of Greifswald, Northern Germany, between 2012 and 2018. In total, 460 adults from the general population aged 40 to 75 years and without known cardiovascular disease wore tri-axial accelerometers (ActiGraph Model GT3X+, Pensacola, FL) on the hip for seven consecutive days. A wear time of ≥ 10 h on ≥ 4 days was required for analyses. WC (cm) and BMI (kg m− 2) were measured in a standardized way. Separate multilevel mixed-effects linear regression analyses were used to investigate associations of sedentary bouts (1 to 10 min, >10 to 30 min, and >30 min) with WC and BMI. Models were adjusted for potential confounders including sex, age, school education, employment, current smoking, season of data collection, and composition of accelerometer-based time use.
Results
Participants (66% females) were on average 57.1 (standard deviation, SD 8.5) years old and 36% had a school education >10 years. The mean number of sedentary bouts per day was 95.1 (SD 25.0) for 1-to-10-minute bouts, 13.3 (SD 3.4) for >10-to-30-minute bouts and 3.5 (SD 1.9) for >30-minute bouts. Mean WC was 91.1 cm (SD 12.3) and mean BMI was 26.9 kg m− 2 (SD 3.8). The daily number of 1-to-10-minute bouts was inversely associated with BMI (b = -0.027; p = 0.047) and the daily number of >30-minute bouts was positively associated with WC (b = 0.330; p = 0.001). All other associations were not statistically significant.
Conclusion
The findings provide some evidence on favourable associations of short sedentary bouts as well as unfavourable associations of long sedentary bouts with adiposity markers. Our results may contribute to a growing body of literature that can help to define public health recommendations for interrupting prolonged sedentary periods.
Trial registration
Study 1: German Clinical Trials Register (DRKS00010996); study 2: ClinicalTrials.gov (NCT02990039); study 3: ClinicalTrials.gov (NCT03539237).
Liver dysfunctions are commonly associated with diabetes and mortality in the general
population. However, previous studies lack to define these disorders with hepatic markers from
MRI, which have been shown to be more accurate and sensitive than hepatic ultrasound and
laboratory markers. Further, previous studies defining different categories of prediabetes by oral
glucose tolerance states revealed controversial findings. Hence, this dissertation contributed to
understand the associations of liver dysfunctions with glucose intolerance states and all-cause
mortality in the general population.
In the first part of the dissertation, the associations of MRI-related hepatic steatosis and hepatic
iron overload with prediabetes were investigated. Prediabetes was categorized into IFG, IGT,
(alone or in combination) or previously unknown type 2 diabetes mellitus using OGGT data, as
suggested by the ADA. For analyses, we included 1632 subjects with MRI who participated in
an OGTT and reported no type 2 diabetes mellitus. We found that hepatic steatosis was
positively associated with continuous markers of glucose metabolism. Similarly, subjects with
hepatic steatosis as defined by MRI had a higher relative risk ratio to be in the prediabetes
groups (i-IFG, i-IGT and IFG + IGT) or having undiagnosed diabetes than individuals without
this condition. The observed associations were more obvious for MRI-derived hepatic steatosis
compared to ultrasound. In comparison to hepatic steatosis, we found that MRI-assessed hepatic
iron overload was positively associated only with both 2-hour plasma glucose and the combined
IFG + IGT category. There were no significant associations between hepatic iron overload and
other glucose tolerance states or biomarkers of glucose metabolism, regardless of possible
confounding factors.
In the second part, the associations of liver volume and other markers of hepatic steatosis with
all-cause mortality in the general population were investigated. We included 2769 middle-aged
German subjects with a median follow-up of 8.9 years (23,898 person-years). Serum liver
enzymes and FIB-4 score were used as quantitative markers, while MRI measurements of liver
fat content and total liver volume included as qualitative markers of hepatic steatosis. Compared
to other markers of hepatic steatosis, larger liver volumes were significantly associated with a
nearly three-fold increase in the long-term risk of all-cause mortality. Furthermore, this
association was consistent across all subgroups considered (men vs. women; presence or absence
of metabolic syndrome or type 2 diabetes at baseline). A positive association between FIB-4
score and all-cause mortality was found both in the entire cohort and in women. Likewise,
positive associations of higher serum AST and GGT levels with all-cause mortality were found
in the entire cohort and in men.
To conclude, this dissertation acknowledges the fact that prevention and early intervention of
liver dysfunction has major impact to reduce the burden of public health problems. Thus, our
findings suggest that hepatic markers contributes to an increased risk of prediabetes and all-cause
mortality, which might be helpful to identify high risk groups who need closer attention with
respect to prevention of liver disorders and diabetes.
Background: The aim of our study was to investigate associations of spleen volume with blood count markers and lipid profile in the general population.
Materials & methods: Cross-sectional data from 1,106 individuals aged 30–90 years from the population-based Study of Health in Pomerania (SHIP-START-2) were analyzed. Blood count markers included red blood cell (RBC) counts, hemoglobin, platelet count, and white blood cell (WBC) counts. Lipid profile included total-cholesterol, high-density lipoprotein-cholesterol (HDL-C), and low-density lipoprotein-cholesterol (LDL-C) as well as triglycerides. Linear regression models adjusted for age, sex, body height, and weight were used to associate standardized spleen volume with blood counts and lipid profile markers.
Results: Spleen volume was positively associated with RBC (β = 0.05; 95% confidence interval [CI] = 0.03 to 0.08) and hemoglobin (β = 0.05; 95% CI = 0.01 to 0.09) but inversely with platelet count (β = −16.3; 95% CI = –20.5 to −12.1) and WBC (β = −0.25; 95% CI = −0.37 to −0.14). Furthermore, spleen volume showed inverse associations with total cholesterol (β = −0.17; 95% CI = −0.24 to −0.09), HDL-C (β = −0.08; 95% CI = −0.10 to −0.05), and LDL-C (β = −0.12; 95% CI = −0.17 to −0.06). There was no significant association of spleen volume with triglycerides.
Conclusion: Our study showed that the spleen volume is associated with markers of the blood count and lipid profile in the general population.
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.
Frontotemporal lobar degeneration (FTLD) is likely to be the second-most common cause of dementia in individuals under 65 years of age. Pathognomonic changes in personality, behavior and motivation are known to lead to high caregiver stress and burden, with little support being available. The aim of this work is to present the current state of knowledge on the characteristics, challenges and unmet needs of caregivers as well as on possible interventions.
Two scoping reviews on caregiver burden using the PRISMA checklist for scoping reviews were conducted using PubMed, Web of Science and ScienceDirect in April 2017 and November 2019, respectively. A total of 107 articles were considered eligible and were analyzed qualitatively and summarized.
Our results show that caregivers of patients with FTLD are often female, spouses of the PwD, younger in age, have underage children and provide care at home. Behavioral and motivational disturbances in the PwD are perceived to be the most burdensome aspects of caregiving. Those caring for an individual with the bvFTD subtype thus report higher levels of burden than caregivers of an individual with a form of PPA. With rising dementia severity, caregivers report higher levels of burden. Many caregivers experience a decline in their own physical and mental health as well as a significant financial burden resulting from care duties. The deterioration of the relationship between the PwD and their caregivers is a main burdensome aspect. Only few interventions were conducted so far, and none of those that were identified were designed as an RCT. The most efficacious interventions were those aimed directly at caregivers, whereas interventions aiming at the amelioration of symptoms in the PwD showed little effect.
Further research should reproduce and validate efficacious interventions and establish new interventional approaches. Another focus should be set on the situation of underage children of individuals with FTLD and relatives of a person with hereditary FTD. More research from non-Western countries is needed in order to identify culture-specific factors of caregiver burden. Along those lines, support structures for FTLD caregivers should be assessed on a local basis and extended accordingly. So far, no study has assessed the relationship between caregiver burden and possible consequences for the quality of care provided to the PwD in FTLD specifically. Awareness both in the wider population and among healthcare professionals is an urgent need for the future since FTLD is often misdiagnosed, leading to a delay in obtaining the correct diagnosis and access to suitable support.
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.
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.
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).