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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
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).
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: Iodine deficiency disorders (IDD) represent a global health threat to individuals and societies. IDD prevention programmes have been introduced in many parts of the world. However, challenges remain, particularly in Europe due to fragmentation and diversity of approaches that are not harmonized. Objectives: This review is dedicated to the public-health impact of IDD prevention programmes. It sums up experiences collected by the EUthyroid consortium so far and provides information on stakeholders that should be involved in actions directed to improve the impact of IDD prevention. Methods: A joint European database for combining registry-based outcome and monitoring data as well as tools for harmonizing study methods were established. Methods for analyzing thyroglobulin from a dried blood spot are available for assessing the iodine status in the general population and at-risk groups. Mother-child cohorts are used for in-depth analysis of the potential impact of mild-to-moderate iodine deficiency on the neurocognitive development of the offspring. A decision-analytic model has been developed to evaluate the long-term effectiveness and cost effectiveness of IDD prevention programmes. Results: EUthyroid has produced tools and infrastructure to improve the quality of IDD monitoring and follows a dissemination strategy targeting policymakers and the general public. There are tight connections to major stakeholders in the field of IDD monitoring and prevention. Conclusions: EUthyroid has taken steps towards achieving a euthyroid Europe. Our challenge is to inspire a greater sense of urgency in both policymakers and the wider public to address this remediable deficit caused by IDD.
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).
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.
Mendelian randomization (MR) is a framework for assessing causal inference using cross-sectional data in combination with genetic information. This paper summarizes statistical methods commonly applied and strait forward to use for conducting MR analyses including those taking advantage of the rich dataset of SNP-trait associations that were revealed in the last decade through large-scale genome-wide association studies. Using these data, powerful MR studies are possible. However, the causal estimate may be biased in case the assumptions of MR are violated. The source and the type of this bias are described while providing a summary of the mathematical formulas that should help estimating the magnitude and direction of the potential bias depending on the specific research setting. Finally, methods for relaxing the assumptions and for conducting sensitivity analyses are discussed. Future researches in the field of MR include the assessment of non-linear causal effects, and automatic detection of invalid instruments.
Mendelian randomization (MR) is a framework for assessing causal inference using cross-sectional data in combination with genetic information. This paper summarizes statistical methods commonly applied and strait forward to use for conducting MR analyses including those taking advantage of the rich dataset of SNP-trait associations that were revealed in the last decade through large-scale genome-wide association studies. Using these data, powerful MR studies are possible. However, the causal estimate may be biased in case the assumptions of MR are violated. The source and the type of this bias are described while providing a summary of the mathematical formulas that should help estimating the magnitude and direction of the potential bias depending on the specific research setting. Finally, methods for relaxing the assumptions and for conducting sensitivity analyses are discussed. Future researches in the field of MR include the assessment of non-linear causal effects, and automatic detection of invalid instruments.
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.
Background
Pregnancy and the postpartum period are times when women are at increased risk for depression and mental problems. This may also negatively affect the foetus. Thus, there is a need for interventions with low-threshold access and care. Telemedicine interventions are a promising approach to address these issues. This systematic literature review examined the efficacy of telemedicine interventions for pregnant women and/or new mothers to address mental health-related outcomes. The primary objective was to analyse whether telemedicine interventions can reduce mental health problems in pregnant women and new mothers. The secondary aim was to clarify the impact of type of interventions, their frequency and their targets.
Methods
Inclusion criteria: randomized controlled trials, with participants being pregnant women and/or new mothers (with infants up to twelve months), involving telemedicine interventions of any kind (e.g. websites, apps, chats, telephone), and addressing any mental health-related outcomes like depression, postnatal depression, anxiety, stress and others. Search terms were pregnant women, new mothers, telemedicine, RCT (randomised controlled trials), mental stress as well as numerous synonyms including medical subject headings. The literature search was conducted within the databases PubMed, Cochrane Library, Web of Science and PsycINFO. Screening, inclusion of records and data extraction were performed by two researchers according to the PRISMA guidelines, using the online tool CADIMA.
Results
Forty four articles were included. A majority (62%) reported significantly improved mental health-related outcomes for participants receiving telemedicine interventions compared to control. In particular (internet-delivered) Cognitive Behavioural Therapy was successful for depression and stress, and peer support improved outcomes for postnatal depression and anxiety. Interventions with preventive approaches and interventions aimed at symptom reduction were largely successful. For the most part there was no significant improvement in the symptoms of anxiety.
Conclusion
Telemedicine interventions evaluated within RCTs were mostly successful. However, they need to be designed to specifically target a certain mental health issue because there is no one-size-fits-all approach. Further research should focus on which specific interventions are appropriate for which mental health outcomes in terms of intervention delivery modes, content, target approaches, etc. Further investigation is needed, in particular with regard to anxiety.
Background
In combination with systematic routine screening, brief alcohol interventions have the potential to promote population health. Little is known on the optimal screening interval. Therefore, this study pursued 2 research questions: (i) How stable are screening results for at‐risk drinking over 12 months? (ii) Can the transition from low‐risk to at‐risk drinking be predicted by gender, age, school education, employment, or past week alcohol use?
Methods
A sample of 831 adults (55% female; mean age = 30.8 years) from the general population was assessed 4 times over 12 months. The Alcohol Use Disorders Identification Test—Consumption was used to screen for at‐risk drinking each time. Participants were categorized either as low‐risk or at‐risk drinkers at baseline, 3, 6, and 12 months later. Stable and instable risk status trajectories were analyzed descriptively and graphically. Transitioning from low‐risk drinking at baseline to at‐risk drinking at any follow‐up was predicted using a logistic regression model.
Results
Consistent screening results over time were observed in 509 participants (61%). Of all baseline low‐risk drinkers, 113 (21%) received a positive screening result in 1 or more follow‐up assessments. Females (vs. males; OR = 1.66; 95% confidence intervals [95% CI] = 1.04; 2.64), 18‐ to 29‐year‐olds (vs. 30‐ to 45‐year‐olds; OR = 2.30; 95% CI = 1.26; 4.20), and those reporting 2 or more drinking days (vs. less than 2; OR = 3.11; 95% CI = 1.93; 5.01) and heavy episodic drinking (vs. none; OR = 2.35; 95% CI = 1.06; 5.20) in the week prior to the baseline assessment had increased odds for a transition to at‐risk drinking.
Conclusions
Our findings suggest that the widely used time frame of 1 year may be ambiguous regarding the screening for at‐risk alcohol use although generalizability may be limited due to higher‐educated people being overrepresented in our sample.
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.
Background: To reduce the burden of disease attributable to alcohol, screening for at-risk alcohol use in the general population is recommended. Screening is usually carried out at only one point in time although individual alcohol use may change over time and self-reported consumption may be biased by underreporting. However, there are gaps in research on temporal variability of alcohol use. Therefore, this cumulative dissertation investigated (1) changes in drinking patterns within 4 weeks; (2) changes in screening results within 12 months and factors predicting a transition from low-risk to at-risk alcohol use; (3) whether underreporting can be reduced by prompting respondents to recall their alcohol use in the past week prior to screening.
Methods: Participants were adults from the general population recruited in a municipal registry office. For the first paper, 288 alcohol users were assessed four times using Timeline Follow-Back, each one week apart. Changes in drinking patterns were analyzed using latent transition modeling. For the second paper, 831 control group participants of a randomized controlled trial were screened for at-risk alcohol use at baseline, 3, 6, and 12 months later using the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). The transition from low-risk to at-risk alcohol use was predicted using logistic regression. For the third paper, 2,379 alcohol users were screened for at-risk alcohol use using the AUDIT-C, either before or after receiving the prompt to recall their past week alcohol use. Data were analyzed using logistic regression.
Results: Within 4 weeks, 35 percent of alcohol users changed their drinking pattern. Changes were more likely for individuals with moderate or heavy compared to light drinking. Within 12 months, 30 percent of alcohol users changed their screening result. Changes were more likely for at-risk compared to low-risk alcohol users. Transitioning from low-risk to at-risk alcohol use was more likely for women (vs. men; Odds Ratio, OR = 1.66), 18- to 29-year-old adults (vs. 30- to 45-year-old adults; OR = 2.30), and individuals reporting two or more drinking days in the past week (vs. less than two; OR = 3.11). When respondents were prompted to recall their alcohol use in the past week prior to screening, they were less likely to report at-risk alcohol use compared to when the screening was conducted without prior prompt (OR = 0.83).
Conclusions: One in three alcohol users changed their consumption, some of them even within a period as short as 4 weeks. These changes might compromise the validity of screening that is commonly based on a single assessment of typical alcohol use. Furthermore, underreporting cannot be reduced by prompting individuals to recall their alcohol use in the past week prior to the screening for at-risk alcohol use. Rather, consecutive questionnaires addressing different aspects of alcohol use within a single survey might be a potential source of bias.
CFTR encodes for a chloride and bicarbonate channel expressed at the apical membrane of polarized epithelial cells. Transepithelial sodium transport mediated by the amiloride-sensitive sodium channel ENaC is thought to contribute to the manifestation of CF disease. Thus, ENaC is a therapeutic target in CF and a valid cystic fibrosis modifier gene. We have characterized SCNN1B as a genetic modifier in the three independent patient cohorts of F508del-CFTR homozygotes. We could identify a regulatory element at SCNN1B to the genomic segment rs168748-rs2303153-rs4968000 by fine-mapping (Pbest = 0.0177), consistently observing the risk allele rs2303153-C and the contrasting benign allele rs2303153-G in all three patient cohorts. Furthermore, our results show that expression levels of SCNN1B are associated with rs2303153 genotype in intestinal epithelia (P = 0.003). Our data confirm that the well-established biological role of SCNN1B can be recognized by an association study on informative endophenotypes in the rare disease cystic fibrosis and calls attention to reproducible results in association studies obtained from small, albeit carefully characterized patient populations.
Introduction: With the increased emergence of SARS-CoV-2 variants, the impact on schools and preschools remains a matter of debate. To ensure that schools and preschools are kept open safely, the identification of factors influencing the extent of outbreaks is of importance.
Aim: To monitor dynamics of COVID-19 infections in schools and preschools and identify factors influencing the extent of outbreaks.
Methods: In this prospective observational study we analyzed routine surveillance data of Mecklenburg-Western Pomerania, Germany, from calendar week (CW) 32, 2020 to CW19, 2021 regarding SARS-CoV-2 infection events in schools and preschools considering changes in infection control measures over time. A multivariate linear regression model was fitted to evaluate factors influencing the number of students, teachers and staff tested positive following index cases in schools and preschools. Due to an existing multicollinearity in the common multivariate regression model between the variables “face mask obligation for children” and “face mask obligation for adults”, two further separate regression models were set up (Multivariate Model Adults and Multivariate Model Children).
Results: We observed a significant increase in secondary cases in preschools in the first quarter of 2021 (CW8 to CW15, 2021), and simultaneously a decrease in secondary cases in schools. In multivariate regression analysis, the strongest predictor of the extent of the outbreaks was the teacher/ caregiver mask obligation (B = −1.9; 95% CI: −2.9 to −1.0; p < 0.001). Furthermore, adult index cases (adult only or child+adult combinations) increased the likelihood of secondary cases (B = 1.3; 95% CI: 0.9 to 1.8; p < 0.001). The face mask obligation for children also showed a significant reduction in the number of secondary cases (B = −0.6; 95% CI: −0.9 to −0.2; p = 0.004.
Conclusion: The present study indicates that outbreak events at schools and preschools are effectively contained by an obligation for adults and children to wear face masks.
Frequency of biopsies after the disclosure of incidental findings from whole-body research MRI
(2021)
Large-scale, population-based cohort studies gather a range of data from participants over extended periods of time with the goal of providing researchers with information regarding the health status, prevalence of disease, and risk factors in a regional population. Examinations conducted in the context of population-based studies include imaging and laboratory testing and may yield abnormal results, also called incidental findings. According to predetermined disclosure policies, incidental findings may be disclosed to study participants. Evidence shows that the disclosure of incidental findings results in medical follow-up as research participants and their physicians seek to clarify the significance of findings.
This work examined the effect of disclosing incidental findings from whole-body MRI (wb-MRI) on the frequency and organ system of biopsies in participants in the Study of Health in Pomerania (SHIP), a population-based cohort study in Mecklenburg-West Pomerania. As most of the incidental wb-MRI findings involved unclear masses and lesions, we hypothesized that the disclosure of wb-MRI findings would lead to an increase in diagnostic biopsies. Based on current data showing that the outcomes of incidental imaging findings are frequently clinically irrelevant, we further hypothesized that an increase in biopsies would not translate to a clinically relevant increase in diagnoses of malignancies. We also took disclosed laboratory findings into account, as they were disclosed to all SHIP participants and may play a role in the decision to pursue a biopsy.
We found that the rate of biopsies increased after participation in SHIP and disclosure of incidental MRI and laboratory findings. Overall, most biopsies showed nonmalignant findings, indicating likely overdiagnosis and overtesting resulting from the disclosure of incidental findings in our cohort. However, subgroups of participants with disclosed MRI findings had a higher proportion of biopsies revealing premalignant or malignant diagnoses after SHIP, indicating that the applied decision rules for disclosure of MRI findings led to the identification of individuals with an elevated risk for premalignant or malignant diagnoses. The clinical relevance of these diagnoses is unclear and overdiagnosis cannot be ruled out.
In summary, we recommend more restrictive disclosure policies for incidental imaging findings in research to protect research participants from overtesting and to reduce bias. Further studies regarding the long-term morbidity and mortality of participants are needed to better understand the therapeutic impact of the disclosure of incidental wb-MRI findings in the research setting.
Guidelines and Standard Frameworks for AI in Medicine: Protocol for a Systematic Literature Review
(2023)
Background: Applications of artificial intelligence (AI) are pervasive in modern biomedical science. In fact, research results suggesting algorithms and AI models for different target diseases and conditions are continuously increasing. While this situation undoubtedly improves the outcome of AI models, health care providers are increasingly unsure which AI model to use due to multiple alternatives for a specific target and the “black box” nature of AI. Moreover, the fact that studies rarely use guidelines in developing and reporting AI models poses additional challenges in trusting and adapting models for practical implementation.
Objective: This review protocol describes the planned steps and methods for a review of the synthesized evidence regarding the quality of available guidelines and frameworks to facilitate AI applications in medicine.
Methods: We will commence a systematic literature search using medical subject headings terms for medicine, guidelines, and machine learning (ML). All available guidelines, standard frameworks, best practices, checklists, and recommendations will be included, irrespective of the study design. The search will be conducted on web-based repositories such as PubMed, Web of Science, and the EQUATOR (Enhancing the Quality and Transparency of Health Research) network. After removing duplicate results, a preliminary scan for titles will be done by 2 reviewers. After the first scan, the reviewers will rescan the selected literature for abstract review, and any incongruities about whether to include the article for full-text review or not will be resolved by the third and fourth reviewer based on the predefined criteria. A Google Scholar (Google LLC) search will also be performed to identify gray literature. The quality of identified guidelines will be evaluated using the Appraisal of Guidelines, Research, and Evaluation (AGREE II) tool. A descriptive summary and narrative synthesis will be carried out, and the details of critical appraisal and subgroup synthesis findings will be presented.
Results: The results will be reported using the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses) reporting guidelines. Data analysis is currently underway, and we anticipate finalizing the review by November 2023.
Conclusions: Guidelines and recommended frameworks for developing, reporting, and implementing AI studies have been developed by different experts to facilitate the reliable assessment of validity and consistent interpretation of ML models for medical applications. We postulate that a guideline supports the assessment of an ML model only if the quality and reliability of the guideline are high. Assessing the quality and aspects of available guidelines, recommendations, checklists, and frameworks—as will be done in the proposed review—will provide comprehensive insights into current gaps and help to formulate future research directions.
International Registered Report Identifier (IRRID): DERR1-10.2196/47105
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: Securing future blood supply is a major issue of transfusion safety. In this prospective 10-year longitudinal study we enrolled all blood donation services and hospitals of the federal state Mecklenburg-Western Pomerania. Methods and Results: From 2005 to 2015 (time period with major demographic effects), whole blood donation numbers declined by 18%. In male donors this paralleled the demographic change, while donation rates of females declined 12.4% more than expected from demography. In parallel, red cell transfusion rates/1,000 population decreased from 2005 to 2015 from 56 to 51 (-8.4%), primarily due to less transfusions in patients >60 years. However, the transfusion demand declined much less than blood donation numbers: -13.5% versus -18%, and the population >65 years (highest transfusion demand) will further increase. The key question is whether the decline in transfusion demand observed over the previous years will further continue, hereby compensating for reduced blood donation numbers due to the demographic change. The population structure of Mecklenburg-Western Pomerania reflects all Eastern German federal states, while the Western German federal states will reach similar ratios of age groups 18-64 years / ≥65 years about 10 years later. Conclusions: Regular monitoring of age- and sex-specific donation and transfusion data is urgently required to allow transfusion services strategic planning for securing future blood supply.
Introduction
Stroke is the leading neurological cause of adult long-term disability in Europe. Even though functional consequences directly related to neurological impairment are well studied, post-stroke trajectories of functional health according to the International Classification of Functioning, Disability and Health are poorly understood. Particularly, no study investigated the relationship between post-stroke trajectories of activities of daily living (ADL) and self-rated health (SRH). However, such knowledge is of major importance to identify patients at risk of unfavourable courses. This prospective observational study aims to investigate trajectories of ADL and SRH, and their modifying factors in the course of the first year after stroke.
Methods and analysis
The study will consecutively enrol 300 patients admitted to a tertiary care hospital with acute ischaemic stroke or transient ischaemic attack (TIA; Age, Blood Pressure, Clinical Features, Duration of symptoms, Diabetes score ≥3). Patient inclusion is planned from May 2021 to September 2022. All participants will complete an interview assessing ADL, SRH, mental health, views on ageing and resilience-related concepts. Participants will be interviewed face-to-face 1–5 days post-stroke/TIA in the hospital; and will be followed up after 6 weeks, 3 months, 6 months and 12 months via telephone. The 12-month follow-up will also include a neurological assessment. Primary endpoints are ADL operationalised by modified Rankin Scale scores and SRH. Secondary outcomes are further measures of ADL, functional health, physical activity, falls and fatigue. Views on ageing, social support, resilience-related concepts, affect, frailty, illness perceptions and loneliness will be examined as modifying factors. Analyses will investigate the bidirectional relationship between SRH and ADL using bivariate latent change score models.
Ethics and dissemination
The study has been approved by the institutional review board of the University Medicine Greifswald (Ref. BB 237/20). The results will be disseminated through scientific publications, conferences and media. Moreover, study results and potential implications will be discussed with patient representatives.
Trial registration number NCT04704635.
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.
Type 2 diabetes mellitus is one of the most challenging health problems for the next decades. The impact of type 2 diabetes mellitus on health care systems is largely driven by the increasing prevalence, the management of the disease and subsequent comorbidities, even in people with prediabetes or undiagnosed type 2 diabetes mellitus. An early detection of high risk groups is necessary to identify and modify risk factors such as obesity, physical inactivity or cigarette smoking which showed regional disparities in their distribution within a country. This leads to the assumption that there might be regional disparities regarding the prevalence and incidence of type 2 diabetes mellitus as well. For Germany as for other countries, comparable data on possible regional disparities in the prevalence and incidence of type 2 diabetes mellitus are missing. The aim of the present dissertation is to estimate the prevalence and incidence of type 2 diabetes mellitus on regional level within Germany, and to estimate the smoking prevalence as a modifiable risk factor in individuals with type 2 diabetes mellitus using data from the Diabetes Collaborative Research of Epidemiologic Studies consortium (DIAB CORE) within the Competence Net Diabetes in Germany. Well comparable data of five regional studies and one nationwide reference study are included: the Study of Health in Pomerania (SHIP); the Cardiovascular Disease, Living and Ageing in Halle Study (CARLA); the Dortmund Health Study (DHS); the Heinz Nixdorf Recall Study (HNR); the Cooperative Health Research in the Region of Augsburg Study (KORA); and the German National Health Interview and Examination Survey 1998 (GNHIES 98). First, the prevalence of type 2 diabetes mellitus was estimated. Data from five regional population-based studies and one nationwide study conducted between 1997 and 2006 with participants aged 45 to 74 years were analyzed. Type 2 diabetes mellitus prevalence estimates based on self-reports (standardized to the German population for the regional studies, reference date 2007/12/31) were compared. Of 11,688 participants of the regional studies, 1,008 had a known type 2 diabetes mellitus, corresponding to a prevalence of 8.6% (95% confidence interval [CI] 8.1% 9.1%). The standardized prevalence was highest in the East with 12.0% (95% CI 10.3% 13.7%) and lowest in the South of Germany with 5.8% (95% CI 4.9% 6.7%).Second, the incidence of type 2 diabetes mellitus was estimated. Data from participants (baseline age 45 to 74 years) from five regional population-based studies were included. The incidence rates per 1,000 person-years (95% CI) and the cumulative incidence (95% CI) from regional studies were directly standardized to the German population (reference date 2007/12/31) and weighted by inverse probability weights for losses to follow-up. Of 8,787 participants, 521 (5.9%) developed type 2 diabetes mellitus corresponding to an incidence rate of 11.8 per 1,000 person-years (95% CI 10.8 12.9). The incidence of known type 2 diabetes mellitus showed regional disparities within Germany. The incidence was highest in the East and lowest in the South of Germany with 16.9 (95% CI 13.3 21.8) vs. 9.0 (95% CI 7.4 11.1) per 1,000 person-years, respectively. Third, the smoking prevalence in participants aged 20 to 79 years with type 2 diabetes mellitus in the regional SHIP and the nationwide GNHIES 98 was estimated. Prevalence estimates of cigarette smoking were calculated using weights reflecting the European adult population (reference date 2005/12/31). The overall prevalence of current smoking was lower among participants with type 2 diabetes mellitus than among participants without type 2 diabetes mellitus (17.3% vs. 38.0% in SHIP and 24.7% vs. 32.1% in GNHIES 98). In both studies, the prevalence of current smoking was highest in men aged 20 to 39 years, in particular among men with type 2 diabetes mellitus. To conclude, considerable disparities in prevalence and incidence of type 2 diabetes mellitus indicate the need for interventions on the regional level within Germany. Former smoking was more prevalent among both men and women with type 2 diabetes mellitus in comparison to current and non-smoking. This finding probably reflects behavioural changes secondary to the disease onset and medical counselling. The finding that men aged 20 to 39 years with type 2 diabetes mellitus were more often current smokers than men without type 2 diabetes mellitus underpins the importance of smoking as one of the main modifiable risk factors for type 2 diabetes mellitus.
Due to demographic changes, medical and nursing care in Germany faces new challenges. Combined with the aging of the population, an increase in age-associated diseases, including dementia, is to be expected. In addition to the increase in the number of persons with certain age-specific diseases, the aging of the German population also results in an increase in the number of persons with multiple diseases. The coexistence of dementia and comorbidity in people with dementia creates complex challenges for ambulatory and clinical care. The existence of comorbidity also leads to significantly higher medical costs.
Implementing new collaborative care programs and redistributing the responsibilities among outpatient care providers in the ambulatory care of patients may be one approach to ensure and improve the life and care situation of people with dementia. Collaborative Dementia Care Management, with the concept of support of general practitioners by specific qualified nurses demonstrated an adequate and effective approach for the compensation of supply deficits of PwD in the primary care sector. The aim of the dissertation is the health economic analysis of comorbidities in dementia and the evaluated Dementia Care Management of the DelpHi-MV study as an innovative approach for care and treatment of comorbidities in people with dementia. It is assumed that the cost of care for PwD varies depending on comorbidity and socio-demographic and clinical characteristics. Therefore, the health care costs of people with dementia are calculated and the association between these care costs and comorbidity and socio-demographic and clinical factors of PwD was analyzed. In addition, we aimed to detect important subgroups (e.g. PwD with low, high or very high comorbidity) who benefit most from the DCM intervention and for whom a significant effect on costs, Quality-adjusted Life Years (QALY) and on the individual cost-effectiveness could be achieved, considering different sociodemographic and clinical characteristics like comorbidity.
In the sample of PwD comorbidity was highly prevalent. 47% of PwD had a very high, 37% a high and only 16% a low comorbidity in addition to dementia. The most prevalent co-existing comorbidity were diabetes mellitus (42%), peripheral vascular disease (28%) and cerebrovascular disease (25%). Total costs significantly increased by 528 € (SE=214, CI 95%=109-947, p=0.014) with each further comorbidity, especially due to significantly higher cost for medication and medical aids. Compared with a low comorbidity, a very high comorbidity was significantly associated with 818 € (SE=168, CI 95%= 489-1147, p<0.001) higher medication costs and 336 € (SE=161, CI 95%=20-652, p=0.037) higher cost for medical aids. There was no significant association between a higher comorbidity and cost for formal care services. The probability of DCM being cost-effective at a willingness-to-pay of 40,000€/QALY was higher especially in PwD having a high comorbidity (96% vs. 26% for patients with a low comorbidity), in females (96% vs. 16% for males), in those living alone (96% vs. 26% for those living not alone) and in those being moderately to severely cognitively (100% vs. 3% for patients without cognitive impairment) and functionally impaired (97% vs. 16% for patients without functional impairment).
Comorbidity in PwD represents a substantial financial burden on healthcare payer’s and is a challenge for patients, healthcare providers and the health system. Innovative approaches are needed to achieve a patient-oriented management of treatment and care in comorbid PwD to reduce long-term costs. Collaborative dementia care management is one approach to solve these problems in dementia care. Thereby, patients characteristics significantly affect the cost-effectiveness of collaborative care. Female patients, patients living alone, and those with a high comorbidity as well as those being moderately cognitively and functionally impaired benefit most from DCM. For those subgroups of patients, healthcare payers could gain the highest cost savings and the highest effects on QALYs when the DCM approach will be implemented.
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
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.
Scope
Previous work identified three metabolically homogeneous subgroups of individuals (“metabotypes”) using k‐means cluster analysis based on fasting serum levels of triacylglycerol, total cholesterol, HDL cholesterol, and glucose. The aim is to reproduce these findings and describe metabotype groups by dietary habits and by incident disease occurrence.
Methods and results
1744 participants from the KORA F4 study and 2221 participants from the KORA FF4 study are assigned to the three metabotype clusters previously identified by minimizing the Euclidean distances. In both KORA studies, the assignment of participants results in three metabolically distinct clusters, with cluster 3 representing the group of participants with the most unfavorable metabolic characteristics. Individuals of cluster 3 are further characterized by the highest incident disease occurrence during follow‐up; they also reveal the most unfavorable diet with significantly lowest intakes of vegetables, dairy products, and fibers, and highest intakes of total, red, and processed meat.
Conclusion
The three metabotypes originally identified in an Irish population are successfully reproduced. In addition to this validation approach, the observed differences in disease incidence across metabotypes represent an important new finding that strongly supports the metabotyping approach as a tool for risk stratification.
(1) Background: Predicting chronic low back pain (LBP) is of clinical and economic interest as LBP leads to disabilities and health service utilization. This study aims to build a competitive and interpretable prediction model; (2) Methods: We used clinical and claims data of 3837 participants of a population-based cohort study to predict future LBP consultations (ICD-10: M40.XX-M54.XX). Best subset selection (BSS) was applied in repeated random samples of training data (75% of data); scoring rules were used to identify the best subset of predictors. The rediction accuracy of BSS was compared to randomforest and support vector machines (SVM) in the validation data (25% of data); (3) Results: The best subset comprised 16 out of 32 predictors. Previous occurrence of LBP increased the odds for future LBP consultations (odds ratio (OR) 6.91 [5.05; 9.45]), while concomitant diseases reduced the odds (1 vs. 0, OR: 0.74 [0.57; 0.98], >1 vs. 0: 0.37 [0.21; 0.67]). The area-under-curve (AUC) of BSS was acceptable (0.78 [0.74; 0.82]) and comparable with SVM (0.78 [0.74; 0.82]) and randomforest (0.79 [0.75; 0.83]); (4) Conclusions: Regarding prediction accuracy, BSS has been considered competitive with established machine-learning approaches. Nonetheless, considerable misclassification is inherent and further refinements are required to improve predictions.
Objectives: An inverse relationship between education and cardiovascular risk has been described, however, the combined association of education, income, and neighborhood socioeconomic status with macrovascular disease is less clear. The aim of this study was to evaluate the association of educational level, equivalent household income and area deprivation with macrovascular disease in Germany.
Methods: Cross-sectional data from two representative German population-based studies, SHIP-TREND (n = 3,731) and KORA-F4 (n = 2,870), were analyzed. Multivariable logistic regression models were applied to estimate odds ratios and 95% confidence intervals for the association between socioeconomic determinants and macrovascular disease (defined as self-reported myocardial infarction or stroke).
Results: The study showed a higher odds of prevalent macrovascular disease in men with low and middle educational level compared to men with high education. Area deprivation and equivalent income were not related to myocardial infarction or stroke in any of the models.
Conclusion: Educational level, but not income or area deprivation, is significantly related to the macrovascular disease in men. Effective prevention of macrovascular disease should therefore start with investing in individual education.
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.
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.
Obesity and diabetes have reached epidemic proportions and have emerged as massive public health problems globally. The etiology of both obesity and diabetes are related, multifactorial, highly complex, and involves interplay of genetic, environmental, socio-economic and physiological factors, which calls for a more extensive research in understanding the risk factors and biological pathways. Hence, this dissertation contributed in part to understanding the role of iron markers in the development of type 2 diabetes mellitus and the role of intrauterine hyperglycemia in influencing the risk of offspring obesity along with investigating potential pathways.
In the first part of my dissertation, the associations of iron markers (ferritin and transferrin) with type 2 diabetes mellitus and metabolic syndrome were investigated using the population-based Study of Health in Pomerania. The present analyses were based on 3,232 participants aged 20-81 years with a follow-up time of nearly 11 years. The results suggest that serum ferritin concentrations were associated with a higher prevalence of type 2 diabetes mellitus and metabolic syndrome in the total population as well as in men. However, the effects of serum ferritin on incident type 2 diabetes mellitus were observed only in women, while the effects on incident metabolic syndrome were seen in the total population. Serum ferritin is also known to reflect systemic inflammation or hepatic dysfunction in addition to increased iron stores. Hence, upon further analyses, the associations were found to be attenuated after adjustment for hepatic enzymes but not after adjustment for inflammation. Transferrin was not associated with any of the outcomes. Thus, our study provides evidence for a link between the iron marker ferritin and type 2 diabetes mellitus and metabolic syndrome, although the association seemed to vary by sex. Moreover, hepatic dysfunction seems likely to be in the pathway between ferritin and type 2 diabetes mellitus and metabolic syndrome.
In the second part of my dissertation, the association between maternal hyperglycemia and the risk of offspring overweight and obesity were investigated using three different cohorts: TEDDY, TEENDIAB and BABYDIAB/BABYDIET. The present analyses were based on a total of 8,103 children who were followed until 6 years of age in TEDDY study and until 18 years of age in TEENDIAB and BABYDIAB/BABYDIET studies. The dissertation revealed that maternal hyperglycemia in general may be associated with increased risk for childhood overweight and obesity, and that the association gets stronger as children grow older, with the risk being clearly evident at late childhood and adolescence. Moreover, this dissertation adds that this association can be driven by different pathways based on the type of maternal diabetes to which the offspring was exposed. The association of maternal gestational diabetes mellitus with offspring overweight can be largely explained by the confounding influence of maternal BMI, whereas the association of maternal type 1 diabetes mellitus with offspring overweight can be substantially explained by birthweight in all three studies. In our attempt to understand biological pathways at a cellular level, we found that the offspring metabolome was unlikely to be in the causal pathway between maternal type 1 diabetes mellitus and overweight, because this association could not be explained by any of the potentially relevant metabolites.
To conclude, this dissertation acknowledges the fact that prevention and early intervention of obesity and diabetes is of paramount importance to lessen the impact of these public health problems. Thus, our findings of the role of ferritin in increasing the risk of type 2 diabetes mellitus/ metabolic syndrome and the role of intrauterine hyperglycemia in increasing the risk of offspring overweight helped to identify particular risk groups who may need closer attention with respect to prevention of obesity and diabetes.
Context: 3,5-Diiodo-<smlcap>L</smlcap>-thyronine (3,5-T<sub>2</sub>) is a thyroid hormone metabolite which exhibited versatile effects in rodent models, including the prevention of insulin resistance or hepatic steatosis typically forced by a high-fat diet. With respect to euthyroid humans, we recently observed a putative link between serum 3,5-T<sub>2</sub> and glucose but not lipid metabolism. Objective: The aim of the present study was to widely screen the urine metabolome for associations with serum 3,5-T<sub>2</sub> concentrations in healthy individuals. Study Design and Methods: Urine metabolites of 715 euthyroid participants of the population-based Study of Health in Pomerania (SHIP-TREND) were analyzed by <sup>1</sup>H-NMR spectroscopy. Multinomial logistic and multivariate linear regression models were used to detect associations between urine metabolites and serum 3,5-T<sub>2</sub> concentrations. Results: Serum 3,5-T<sub>2</sub> concentrations were positively associated with urinary levels of trigonelline, pyroglutamate, acetone and hippurate. In detail, the odds for intermediate or suppressed serum 3,5-T<sub>2</sub> concentrations doubled owing to a 1-standard deviation (SD) decrease in urine trigonelline levels, or increased by 29-50% in relation to a 1-SD decrease in urine pyroglutamate, acetone and hippurate levels. Conclusion: Our findings in humans confirmed the metabolic effects of circulating 3,5-T<sub>2</sub> on glucose and lipid metabolism, oxidative stress and enhanced drug metabolism as postulated before based on interventional pharmacological studies in rodents. Of note, 3,5-T<sub>2</sub> exhibited a unique urinary metabolic profile distinct from previously published results for the classical thyroid hormones.
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.
SummaryBackground: According to the literature, ductoscopy is gaining increasing importance in the diagnosis of intraductal anomalies in cases of pathologic nipple discharge. In a multicenter study, the impact of this method was assessed in comparison with that of standard diagnostics. Patients and Methods: Between 09/2006 and 05/2009, a total of 214 patients from 7 German breast centers were included. All patients underwent elective ductoscopy and subsequent ductal excision because of pathologic nipple discharge. Ductoscopy was compared with the following standard diagnostics: breast sonography, mammography, magnetic resonance imaging (MRI), galactography, cytologic nipple swab, and ductal lavage cytology. The histological and imaging results were compared and contrasted to the results obtained from the nipple swab and cytologic assessment. Results: Sonography had the highest (82.9%) sensitivity, followed by MRI (82.5%), galactography (81.3%), ductoscopy (71.2%), lavage cytology (57.8%), mammography (57.1%), and nipple swab (22.8%). Nipple swabs had the highest (85.5%) specificity, followed by lavage cytology (85.2%), ductoscopy (49.4%), galactography (44.4%), mammography (33.3%), sonography (17.9%), and MRI (11.8%). Conclusion: Currently, ductoscopy provides a direct intraoperative visualization of intraductal lesions. Sensitivity and specificity are similar to those of standard diagnostics. The technique supports selective duct excision, in contrast to the unselective technique according to Urban. Therefore, ductoscopy extends the interventional/diagnostic armamentarium.
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: 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.
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.
Activation of trace amine-associated receptor 1 (TAAR1) in endocrine pancreas is involved in weight regulation and glucose homeostasis. The purpose of this study was the identification and characterization of potential TAAR1 variants in patients with overweight/obesity and disturbed glucose homeostasis. Screening for TAAR1 variants was performed in 314 obese or overweight patients with impaired insulin secretion. The detected variants were functionally characterized concerning TAAR1 cell surface expression and signaling properties and their allele frequencies were determined in the population-based Study of Health in Pomerania (SHIP). Three heterozygous carriers of the single nucleotide missense variants p.Arg23Cys (R23C, rs8192618), p.Ser49Leu (S49L, rs140960896), and p.Ille171Leu (I171L, rs200795344) were detected in the patient cohort. While p.Ser49Leu and p.Ille171Leu were found in obese/overweight patients with slightly impaired glucose homeostasis, p.Arg23Cys was identified in a patient with a complete loss of insulin production. Functional in vitro characterization revealed a like wild-type function for I171L, partial loss of function for S49L and a complete loss of function for R23C. The frequency of the R23C variant in 2018 non-diabetic control individuals aged 60 years and older in the general population-based SHIP cohort was lower than in the analyzed patient sample. Both variants are rare in the general population indicating a recent origin in the general gene pool and/or the consequence of pronounced purifying selection, in line with the obvious detrimental effect of the mutations. In conclusion, our study provides hints for the existence of naturally occurring TAAR1 variants with potential relevance for weight regulation and glucose homeostasis.
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.
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.
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.
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.
Background & Aim: Person-Centered-Care (PCC) requires knowledge about patient preferences. Among People living with Dementia (PlwD) only limited evidence about patient preferences, more specifically quantitative preferences, is available. Additionally, data on congruence of patient preferences with physicians’ judgements are missing. Information on patient preferences and their congruence with physicians’ judgements is expected to support Shared Decision-Making and respectively support the implementation of PCC in dementia. The aim of this dissertation was to analyze patient preferences and physicians’ judgements for PCC, including an assessment of their congruence, based on data from the mixed-methods PreDemCare-study. (Funding: Doctoral Scholarship from the Hans & Ilse Breuer-Stiftung.)
Methods: Development and conduct of a cross-sectional Analytic Hierarchy Process (AHP) survey with n=50 PlwD and n=25 physicians. Individual AHP-weights were calculated with the principal right eigenvector method and aggregated per group by Aggregation of Individual Priorities (AIP) mode. Individual consistency ratios (CRs) were calculated and aggregated per group. Group differences were analyzed descriptively by AIP-derived means and standard deviations of AHP-weights, resulting ranks, and boxplots. Additionally, differences between groups were investigated with independent paired t-tests or Mann Whitney-U tests. The sensitivity of AHP-results at the level of criteria was tested by an exclusion of inconsistent respondents in both groups, with an accepted threshold of the individual CR at ≤ 0.3 for PlwD and ≤ 0.2 for physicians.
Results: Contrary to expectation, PlwD’s and physician’s ranking of AHP-elements did not differ meaningfully. Memory Exercises was the only AHP-criterion, for which a significant difference in AHP-weights could be identified (p-value = 0.01). After inconsistent participants had been excluded, no rank reversals occurred. At the level of criteria, the mean CR for PlwD was 0.261 and 0.181 for physicians, id est (i.e.) below the
defined threshold.
Conclusion: In the selected study setting of the PreDemCare-study, patient preferences and physicians’ judgements for elements of PCC in dementia aligned well, contrary to expectations. Subject to restrictions by small sample sizes, the findings may form a basis to guide the implementation of preference-based, person-centered dementia care.
Introduction: Hearing and vision loss are highly prevalent in elderly adults, and thus frequently occur in conjunction with cognitive impairments. Studies have shown that hearing impairment is associated with a higher risk of dementia. However, evidence concerning the association between vision loss and dementia, as well as the co-occurrence of vision and hearing loss and dementia, has been inconclusive.
Objectives: To assess the association between: (i) either hearing or vision loss and the risk of dementia, as well as between; and (ii) the combination of both sensory impairments and the risk of dementia.
Methods: This case-control study was based on a 5-year data set that included patients aged 65 years and older who had initially been diagnosed with dementia diseases by one of 1,203 general practitioners in Germany between January 2013 and December 2017. In total, 61,354 identified dementia cases were matched to non-dementia controls, resulting in a sample size of 122,708 individuals. Hearing loss and vision loss were identified using the ICD-10 diagnoses documented in the general practitioners’ files prior to the initial dementia diagnosis. Multivariate logistic regression models were fitted to evaluate the associations between visual and/or hearing impairment and the risk of dementia and controlled for sociodemographic and clinical variables.
Results: Hearing impairment was documented in 11.2% of patients with a dementia diagnosis and 9.5% of patients without such a diagnosis. Some form of vision impairment was documented in 28.4% of patients diagnosed with dementia and 28.8% of controls. Visual impairment was not significantly associated with dementia (OR = 0.97, CI = 95% 0.97–1.02, p = 0.219). However, patients with hearing impairment were at a significantly higher risk of developing dementia (OR = 1.26, CI = 95% 1.15–1.38, p < 0.001), a finding that very likely led to the observed significant association of the combination of both visual and hearing impairments and the risk of dementia (OR = 1.14, CI = 95% 1.04–1.24, p = 0.005).
Discussion: This analysis adds important evidence that contributes to the limited body of knowledge about the association between hearing and/or vision loss and dementia. It further demonstrates that, of the two, only hearing impairment affects patients’ cognition and thus contributes to dementia risk.
Background
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.