Development of diabetes complications within coordinated and structured primary healthcare (2011-2020): a 10 year retrospective cohort study of over 200,000 patients in Germany.

BACKGROUND: Diabetes is a growing, costly, and potentially preventable public health issue. In 2004, Germany introduced the GP-centred healthcare programme to strengthen primary care. AIM: To assess the hazards of the most common diabetes-related complications in patients enrolled in GP-centred healthcare in comparison to usual primary care. DESIGN & SETTING: A retrospective cohort study based on German claims data (4 million members) from 2011 to 2020. METHOD: 217,964 patients with diabetes were monitored from 2011-2020. Endpoints were blindness, amputation, myocardial infarction, stroke, coronary heart disease, dialysis, hypoglycaemia and all-case-mortality. Cox proportional-hazards regression models were used for multivariable analysis and adjusted for socio-demographic, practice- and disease-specific characteristics. RESULTS: Compared to usual care (n=98,609 patients), GP-centred healthcare (n=119,355 patients) showed a relative risk reduction of blindness of 12 %, and amputation of 20% over 10 years. The estimated impact of GP-centred healthcare on myocardial infarction, stroke, coronary artery disease, dialysis and mortality is significantly favourable in comparison to usual care. However, the proportional risk of hypoglycaemia (+1.2 %) in the interventional group is higher than in the usual care. CONCLUSIONS: Enrolment in GP-centred healthcare appears to result in a consistent reduction of the relative risk of diabetes-related complications over 10 years. The significant difference in contrast to usual care may be explained by robust, structured primary care provision, including the diabetes disease management programme and improved coordination and networking of care within primary and secondary care.

Digital Medication Management in Polypharmacy­Findings of a Cluster-Randomized, Controlled Trial With a Stepped-Wedge Design in Primary Care Practices (AdAM).

BACKGROUND: Inappropriate drug prescriptions for patients with polypharmacy can have avoidable adverse consequences. We studied the effects of a clinical decision-support system (CDSS) for medication management on hospitalizations and mortality. METHODS: This stepped-wedge, cluster-randomized, controlled trial involved an open cohort of adult patients with polypharmacy in primary care practices (=clusters) in Westphalia-Lippe, Germany. During the period of the intervention, their medication lists were checked annually using the CDSS. The CDSS warns against inappropriate prescriptions on the basis of patient-related health insurance data. The combined primary endpoint consisted of overall mortality and hospitalization for any reason. The secondary endpoints were mortality, hospitalizations, and high-risk prescription. We analyzed the quarterly health insurance data of the intention-to-treat population with a mixed logistic model taking account of clustering and repeated measurements. Sensitivity analyses addressed effects of the COVID-19 pandemic and other effects. RESULTS: 688 primary care practices were randomized, and data were obtained on 42 700 patients over 391 994 quarter years. No significant reduction was found in either the primary endpoint (odds ratio [OR] 1.00; 95% confidence interval [0.95; 1.04]; p = 0.8716) or the secondary endpoints (hospitalizations: OR 1.00 [0.95; 1.05]; mortality: OR 1.04 [0.92; 1.17]; high-risk prescription: OR 0.98 [0.92; 1.04]). CONCLUSION: The planned analyses did not reveal any significant effect of the intervention. Pandemic-adjusted analyses yielded evidence that the mortality of adult patients with polypharmacy might potentially be lowered by the CDSS. Controlled trials with appropriate follow-up are needed to prove that a CDSS has significant effects on mortality in patients with polypharmacy.

From niche topic to inclusion in the curriculum - design and evaluation of the elective course "climate change and health".

Objective: At the Medical Faculty of the Goethe University Frankfurt am Main, the elective course "climate change and health" was offered to students in the clinical phase of their medical studies for the first time in the winter semester 2021/22 (any unfilled places were made available to interested students studying other subjects). Despite attracting considerable attention, this topic has not yet been incorporated into the curriculum of medical studies. Our aim was therefore to teach students about climate change and discuss its effects on human health. The students evaluated the elective in terms of various factors relating to knowledge, attitudes and behavior. Project description: The elective focused on the concept of Planetary Health, with an emphasis on the health consequences of climate change, as well as possibilities for action and adaptation in clinical and practical settings. The course took place in three live, online sessions (with inputs, discussion, case studies and work in small groups), as well as online preparation and a final written assignment for which students were asked to reflect on the subject. The standardized teaching evaluation questionnaire (=didactic dimension) of Goethe University was used online to evaluate the elective, whereby the questionnaire was extended to include the measurement of changes in students' agreement with items (dimensions) relating to knowledge, attitudes and behavior (personal behavior and behavior as physicians) before and after the course (pre/post comparison). Results: Students expressed high levels of satisfaction with the course content, the presentation of the course, and the organization of the elective. This was reflected in very good to good overall ratings. The pre/post comparisons further showed a significant, positive shift in agreement ratings in almost all dimensions. The majority of respondents also wanted the topic to be firmly embedded in the medical curriculum. Conclusion: The evaluation shows that with respect to the impact of climate change on human health, the elective course had a clear influence on the knowledge, attitudes, and behaviors of the students. In view of the relevance of the topic, it is therefore important that this subject is included in medical curricula in the future.

Changes in the pattern of suicides and suicide attempt admissions in relation to the COVID-19 pandemic.

The consequences of the current COVID-19 pandemic for mental health remain unclear, especially regarding the effects on suicidal behaviors. To assess changes in the pattern of suicide attempt (SA) admissions and completed suicides (CS) in association with the COVID-19 pandemic. As part of a longitudinal study, SA admissions and CS are systematically documented and analyzed in all psychiatric hospitals in Frankfurt/Main (765.000 inhabitants). Number, sociodemographic factors, diagnoses and methods of SA and CS were compared between the periods of March-December 2019 and March-December 2020. The number of CS did not change, while the number of SA significantly decreased. Age, sex, occupational status, and psychiatric diagnoses did not change in SA, whereas the percentage of patients living alone while attempting suicide increased. The rate and number of intoxications as a SA method increased and more people attempted suicide in their own home, which was not observed in CS. Such a shift from public places to home is supported by the weekday of SA, as the rate of SA on weekends was significantly lower during the pandemic, likely because of lockdown measures. Only admissions to psychiatric hospitals were recorded, but not to other institutions. As it seems unlikely that the number of SA decreased while the number of CS remained unchanged, it is conceivable that the number of unreported SA cases increased during the pandemic. Our data suggest that a higher number of SA remained unnoticed during the pandemic because of their location and the use of methods associated with lower lethality.

Use of an Electronic Medication Management Support System in Patients with Polypharmacy in General Practice: A Quantitative Process Evaluation of the AdAM Trial.

Polypharmacy is associated with a risk of negative health outcomes. Potentially inappropriate medications, interactions resulting from contradicting medical guidelines, and inappropriate monitoring, all increase the risk. This process evaluation (PE) of the AdAM study investigates implementation and use of a computerized decision-support system (CDSS). The CDSS analyzes medication appropriateness by including claims data, and hence provides general practitioners (GPs) with full access to patients' medical treatments. We based our PE on pseudonymized logbook entries into the CDSS and used the four dimensions of the Medical Research Council PE framework. Reach, which examines the extent to which the intended study population was included, and Dose, Fidelity, and Tailoring, which examine how the software was actually used by GPs. The PE was explorative and descriptive. Study participants were representative of the target population, except for patients receiving a high level of nursing care, as they were treated less frequently. GPs identified and corrected inappropriate prescriptions flagged by the CDSS. The frequency and intensity of interventions documented in the form of logbook entries lagged behind expectations, raising questions about implementation barriers to the intervention and the limitations of the PE. Impossibility to connect the CDSS to GPs' electronic medical records (EMR) of GPs due to technical conditions in the German healthcare system may have hindered the implementation of the intervention. Data logged in the CDSS may underestimate medication changes in patients, as documentation was voluntary and already included in EMR.

Use of an electronic medication management support system in patients with polypharmacy in general practice: study protocol of a quantitative process evaluation of the AdAM trial.

BACKGROUND: Interventional studies on polypharmacy often fail to significantly improve patient-relevant outcomes, or confine themselves to measuring surrogate parameters. Interventions and settings are complex, with many factors affecting results. The AdAM study's aim is to reduce hospitalization and death by requiring general practitioners (GPs) to use a computerized decision-support system (CDSS). The study will undergo a process evaluation to identify factors for successful implementation and to assess whether the intervention was implemented as intended. OBJECTIVE: To evaluate our complex intervention, based on the Medical Research Council's guideline dimensions. RESEARCH QUESTIONS: We will assess implementation (reach, fidelity, dose, tailoring) by asking: (1) Who took part in the intervention (proportion of GPs using the CDSS, proportion of patients enrolled in them)? Information on GPs' and patients' characteristics will also be collected. (2) How many and which medication alerts were dealt with? (3) Was the intervention implemented as intended? (4) On what days did GPs use the intervention tool? METHODS: The process evaluation is part of a stepped-wedge cluster-randomized controlled trial. Characteristics of practices, GPs and patients using the CDSS will be compared with the non-participating population. CDSS log data will be analyzed to evaluate how the number of medication alerts changed between baseline and 2 months later, and to identify the kind of alerts that were dealt with. Comparison of enrolled patients on weekdays versus weekends will shed light on GPs' use of the CDSS in the absence or presence of patients. Outcomes will be presented using descriptive statistics, and significance tests will be used to identify associations between them. We will conduct subgroup analyses, including time effects to account for software improvements. DISCUSSION: This study protocol is the basis for conducting analyses of the quantitative process evaluation. By providing insight into how GPs conduct medication reviews, the evaluation will provide context to the trial results and support their interpretation. The evaluation relies on the proper documentation by GPs, potentially limiting its explanatory power.

Patient Safety and the COVID-19 Pandemic in Germany: A Repeated Population-Based Cross-Sectional Survey.

The coronavirus (COVID-19) has presented Germany with major challenges and has led to concerns about patient safety. We conducted an observational, population-based, nationwide, repeated cross-sectional survey on patient safety in Germany in 2019, 2020, and 2021. Each of the three samples consisted of 1000 randomly recruited adults. Self-reported data via computer-assisted telephone interviews were taken from TK Monitor of Patient Safety. Perceptions, experience, and knowledge relating to patient safety were assessed. The majority of respondents considered medical treatment to involve risks to patient safety. This proportion decreased during the pandemic. The majority also had a high degree of self-efficacy regarding the prevention of medical errors, whereby the percentage that felt well informed with regard to patient safety rose throughout the pandemic. The proportion of persons that suspected they had in the past experienced an error in their treatment remained steady at one third as well as the reported errors. In 2020, 65% of respondents thought health communication with service providers (e.g., extent and comprehensibility of information) remained unchanged during the pandemic, while 35% reported that medical appointments had been cancelled or postponed. This study is the first to assess patient safety from a general population perspective during the coronavirus pandemic in Germany. COVID-19 had a positive impact on perceived patient safety but no impact on suspected and reported errors. Self-efficacy with regard to medical error prevention steadily increased in the general population, and people considered themselves well informed.

[Subjective and objective work stress among ophthalmologists in private practice in Thuringia : Results of a state-wide survey]. / Subjektive und objektive Arbeitsbelastung niedergelassener Augenärzte in Thüringen : Ergebnisse einer landesweiten Untersuchung.

BACKGROUND: Physicians are highly vulnerable to work-related stress; however, little is known about the workload of ophthalmologists. MATERIAL AND METHODS: In March 2017 a cross-sectional and paper-based survey of all practice-based ophthalmologists in the federal state of Thuringia was conducted. Additionally, data from 2016 and 2009 using physician fee schedule datasets provided by the Thuringian Association of Statutory Health Insurance Physicians were analyzed. RESULTS: The response rate was 27% (n = 42 ophthalmologists) of which 95% (n = 40) exceeded the effort-reward cut-off value (>1) indicating a high level of work stress. The overall number of treatment cases did not show a statistically significant difference between 2016 and 2009 (n = 118 ophthalmologists, p = 0.412). In contrast, the number of treatment cases of patients with type 2 diabetes mellitus and essential (primary) hypertension was statistically significantly higher in 2016 compared to 2009 (n = 118 ophthalmologists, p < 0.05). CONCLUSION: Almost all respondents reported a high level of work stress and this was reflected in the number of treatment cases of patients with type 2 diabetes mellitus and essential hypertension, which was statistically significantly higher in 2016 than in 2009. The results suggest that working conditions should be adapted to meet the needs of chronically ill patients and reduce physicians' workload at the same time.

Incidence and Mortality Trends in German Women with Breast Cancer Using Age, Period and Cohort 1999 to 2008.

Longitudinal analysis investigates period (P), often as years. Additional scales of time are age (A) and birth cohort (C) Aim of our study was to use ecological APC analysis for women breast cancer incidence and mortality in Germany. Nation-wide new cases and deaths were obtained from Robert Koch Institute and female population from federal statistics, 1999-2008. Data was stratified into ten 5-years age-groups starting 20-24 years, ten birth cohorts starting 1939-43, and two calendar periods 1999-2003 and 2004-2008. Annual incidence and mortality were calculated: cases to 100,000 women per year. Data was analyzed using glm and apc packages of R. Breast cancer incidence and mortality increased with age. Secular rise in breast cancer incidence and decline in mortality was observed for period 1999-2008. Breast cancer incidence and mortality declined with cohorts; cohorts 1950s showed highest incidence and mortality. Age-cohort best explained incidence and mortality followed by age-period-cohort with overall declining trends. Declining age-cohort mortality could be probable. Declining age-cohort incidence would require future biological explanations or rendered statistical artefact. Cohorts 1949-1958 could be unique in having highest incidence and mortality in recent time or future period associations could emerge relatively stronger to cohort to provide additional explanation of temporal change over cohorts.

Small-area spatio-temporal analyses of participation rates in the mammography screening program in the city of Dortmund (NW Germany).

BACKGROUND: The population-based mammography screening program (MSP) was implemented by the end of 2005 in Germany, and all women between 50 and 69 years are actively invited to a free biennial screening examination. However, despite the expected benefits, the overall participation rates range only between 50 and 55%. There is also increasing evidence that belonging to a vulnerable population, such as ethnic minorities or low income groups, is associated with a decreased likelihood of participating in screening programs. This study aimed to analyze in more detail the intra-urban variation of MSP uptake at the neighborhood level (i.e. statistical districts) for the city of Dortmund in northwest Germany and to identify demographic and socioeconomic risk factors that contribute to non-response to screening invitations. METHODS: The numbers of participants by statistical district were aggregated over the three periods 2007/2008, 2009/2010, and 2011/2012. Participation rates were calculated as numbers of participants per female resident population averaged over each 2-year period. Bayesian hierarchical spatial models extended with a temporal and spatio-temporal interaction effect were used to analyze the participation rates applying integrated nested Laplace approximations (INLA). The model included explanatory covariates taken from the atlas of social structure of Dortmund. RESULTS: Generally, participation rates rose for all districts over the time periods. However, participation was persistently lowest in the inner city of Dortmund. Multivariable regression analysis showed that migrant status and long-term unemployment were associated with significant increases of non-attendance in the MSP. CONCLUSION: Low income groups and immigrant populations are clustered in the inner city of Dortmund and the observed spatial pattern of persistently low participation in the city center is likely linked to the underlying socioeconomic gradient. This corresponds with the findings of the ecological regression analysis manifesting socioeconomically deprived neighborhoods as risk factors for low attendance in the MSP. Spatio-temporal surveillance of participation in cancer screening programs may be used to identify spatial inequalities in screening uptake and plan spatially focused interventions.

Comparing adaptive and fixed bandwidth-based kernel density estimates in spatial cancer epidemiology.

BACKGROUND: Monitoring spatial disease risk (e.g. identifying risk areas) is of great relevance in public health research, especially in cancer epidemiology. A common strategy uses case-control studies and estimates a spatial relative risk function (sRRF) via kernel density estimation (KDE). This study was set up to evaluate the sRRF estimation methods, comparing fixed with adaptive bandwidth-based KDE, and how they were able to detect 'risk areas' with case data from a population-based cancer registry. METHODS: The sRRF were estimated within a defined area, using locational information on incident cancer cases and on a spatial sample of controls, drawn from a high-resolution population grid recognized as underestimating the resident population in urban centers. The spatial extensions of these areas with underestimated resident population were quantified with population reference data and used in this study as 'true risk areas'. Sensitivity and specificity analyses were conducted by spatial overlay of the 'true risk areas' and the significant (α=.05) p-contour lines obtained from the sRRF. RESULTS: We observed that the fixed bandwidth-based sRRF was distinguished by a conservative behavior in identifying these urban 'risk areas', that is, a reduced sensitivity but increased specificity due to oversmoothing as compared to the adaptive risk estimator. In contrast, the latter appeared more competitive through variance stabilization, resulting in a higher sensitivity, while the specificity was equal as compared to the fixed risk estimator. Halving the originally determined bandwidths led to a simultaneous improvement of sensitivity and specificity of the adaptive sRRF, while the specificity was reduced for the fixed estimator. CONCLUSION: The fixed risk estimator contrasts with an oversmoothing tendency in urban areas, while overestimating the risk in rural areas. The use of an adaptive bandwidth regime attenuated this pattern, but led in general to a higher false positive rate, because, in our study design, the majority of true risk areas were located in urban areas. However, there is a strong need for further optimizing the bandwidth selection methods, especially for the adaptive sRRF.

Detecting cancer clusters in a regional population with local cluster tests and Bayesian smoothing methods: a simulation study.

BACKGROUND: There is a rising public and political demand for prospective cancer cluster monitoring. But there is little empirical evidence on the performance of established cluster detection tests under conditions of small and heterogeneous sample sizes and varying spatial scales, such as are the case for most existing population-based cancer registries. Therefore this simulation study aims to evaluate different cluster detection methods, implemented in the open source environment R, in their ability to identify clusters of lung cancer using real-life data from an epidemiological cancer registry in Germany. METHODS: Risk surfaces were constructed with two different spatial cluster types, representing a relative risk of RR = 2.0 or of RR = 4.0, in relation to the overall background incidence of lung cancer, separately for men and women. Lung cancer cases were sampled from this risk surface as geocodes using an inhomogeneous Poisson process. The realisations of the cancer cases were analysed within small spatial (census tracts, N = 1983) and within aggregated large spatial scales (communities, N = 78). Subsequently, they were submitted to the cluster detection methods. The test accuracy for cluster location was determined in terms of detection rates (DR), false-positive (FP) rates and positive predictive values. The Bayesian smoothing models were evaluated using ROC curves. RESULTS: With moderate risk increase (RR = 2.0), local cluster tests showed better DR (for both spatial aggregation scales > 0.90) and lower FP rates (both < 0.05) than the Bayesian smoothing methods. When the cluster RR was raised four-fold, the local cluster tests showed better DR with lower FPs only for the small spatial scale. At a large spatial scale, the Bayesian smoothing methods, especially those implementing a spatial neighbourhood, showed a substantially lower FP rate than the cluster tests. However, the risk increases at this scale were mostly diluted by data aggregation. CONCLUSION: High resolution spatial scales seem more appropriate as data base for cancer cluster testing and monitoring than the commonly used aggregated scales. We suggest the development of a two-stage approach that combines methods with high detection rates as a first-line screening with methods of higher predictive ability at the second stage.