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Background: In the present study, we investigated the dynamics of immunity over time by measuring anti SARS-CoV-2 IgG antibodies and SARS-CoV-2 specific T-cell responses (interferon-gamma release assay) after two doses of vaccines in residents and health care workers (HCW). Mostly, 224 (98%) residents and 244 (89%) HCW received two doses of mRNA vaccine (BNT162b2, Pfizer-BioNTech); the rest of the participants received heterologous vaccinations with mRNA and vector vaccines. The study was conducted at the time when the Delta variant of SARS-CoV-2 prevailed.Methods: We analyzed blood samples of 228 residents (median age 83.8 years) and of 273 HCW (median age 49.7 years) from five nursing homes and one home for the elderly with assisted living support at one specific time point. Participants received two vaccinations. The blood samples were analyzed for SARS-CoV-2 specific IgG antibody and T-cell responses.Results: The initial immune responses in the younger participants were about 30% higher than in the older age group. Over time the estimated mean of the parameters (estimated from the study sample for the total population) decreased in all groups within the maximum observation period of 232 days. Comorbidities such as coronary heart disease or diabetes mellitus reduced the initial immune responses regardless of age. With regard to measured IgG antibody levels, absolute values decreased over time, whereas the interferon-gamma response remained at a constant level between day 120 and 180 and seemed to be less dependent on the time elapsed after vaccination.Conclusions: Based on our data, it does not seem possible to determine a reliable threshold of robust immunity, but we suggest that high titres of neutralizing capacity and interferon-gamma response might be an indicator of protection against severe COVID-19 courses.

For frequent pediatric chronic conditions, especially less common chronic conditions patient education programs are missing. A recently developed modular patient education approach (ModuS) combines disease-specific modules with generic psychosocial topics. ModuS was associated with increased disease-specific knowledge and improvements in families' well-being in children with asthma. In this study we tested if new developed ModuS programs for seven, mostly less common, chronic conditions show comparable program-associated effects. ModuS education programs were offered to the affected child and its parents. Disease-specific knowledge, children's health-related quality of life, life satisfaction and condition-specific burden were measured before, directly following and 6 weeks after participation in the program. The results were compared with families who received a ModuS asthma program. One hundred and sixty-eight children participated. Families were highly satisfied with the programs. Program participation was associated with increased families' knowledge, children`s self-reported health-related quality of life and reduced condition-specific burden. The results were comparable with the results of 230 families who participated in a ModuS asthma program. The ModuS approach allowed the development of patient education programs for children with a variety of chronic conditions. Therefore, ModuS closed an important healthcare gap. [Co-written with the ModuS Study Group.]

Abstract Background Missing data on tumour stage information is a common problem in population-based cancer registries. Statistical analyses on the level of tumour stage may be biased, if no adequate method for handling of missing data is applied. In order to determine a useful way to treat missing data on tumour stage, we examined different imputation models for multiple imputation with chained equations for analysing the stage-specific numbers of cases of malignant melanoma and female breast cancer. Methods This analysis was based on the malignant melanoma data set and the female breast cancer data set of the cancer registry Schleswig-Holstein, Germany. The cases with complete tumour stage information were extracted and their stage information partly removed according to a MAR missingness-pattern, resulting in five simulated data sets for each cancer entity. The missing tumour stage values were then treated with multiple imputation with chained equations, using polytomous regression, predictive mean matching, random forests and proportional sampling as imputation models. The estimated tumour stages, stage-specific numbers of cases and survival curves after multiple imputation were compared to the observed ones. Results The amount of missing values for malignant melanoma was too high to estimate a reasonable number of cases for each UICC stage. However, multiple imputation of missing stage values led to stage-specific numbers of cases of T-stage for malignant melanoma as well as T- and UICC-stage for breast cancer close to the observed numbers of cases. The observed tumour stages on the individual level, the stage-specific numbers of cases and the observed survival curves were best met with polytomous regression or predictive mean matching but not with random forest or proportional sampling as imputation models. Conclusions This limited simulation study indicates that multiple imputation with chained equations is an appropriate technique for dealing with missing information on tumour stage in population-based cancer registries, if the amount of unstaged cases is on a reasonable level.

Background. Shiga toxin-producing, enteroaggregative Escherichia coli was responsible for the 2011 outbreak of haemolytic uraemic syndrome (HUS). The present single-centre, observational study describes the 1-year course of the disease with an emphasis on kidney function. Outcome data after 1 year are associated with treatment and patient characteristics at onset of HUS. Methods. Patients were treated according to a standardized approach of supportive care, including a limited number of plasmapheresis. On top of this treatment, patients with severe HUS (n = 35) received eculizumab, a humanized anti-C5 monoclonal antibody inhibiting terminal complement activation. The per-protocol decision--to start or omit an extended therapy with eculizumab accompanied by azithromycin--separated the patients into two groups and marked Day 0 of the prospective study. Standardized visits assessed the patients' well-being, kidney function, neurological symptoms, haematological changes and blood pressure. Results. Fifty-six patients were regularly seen during the followup. All patients had survived without end-stage renal disease. Young(er) age alleviated restoring kidney function after acute kidney injury even in severe HUS. After 1 year, kidney function was affected with proteinuria [26.7%; 95% confidence interval (CI) 13.8-39.6], increased serum creatinine (4.4%, CI 0.0-10.4), increased cystatin C (46.7%, CI 32.1-61.3) and reduced (<90 mL/ min) estimated glomerular filtration rate (46.7%, CI 32.1-61.3). Nine of the 36 patients without previous hypertension developed de novo hypertension (25%, CI 10.9-39.1). All these patients had severe HUS. Conclusions. Although shiga toxin-producing Escherichia coli (STEC)-HUS induced by O104:H4 was a life-threatening acute disease, follow-up showed a good recovery of organ function in all patients. Whereas kidney function recovered even after longer duration of dialysis, chronic hypertension developed after severe HUS with neurological symptoms and could not be prevented by the extended therapy. [ABSTRACT FROM AUTHOR]

Objective The main purpose of skin cancer screening is melanoma mortality reduction. Before the implementation of nationwide German skin cancer screening, the pilot project SCREEN was conducted in Schleswig-Holstein in 2003–2004. We aimed to determine whether the pilot project had achieved a mortality reduction. Methods Using an incidence-based approach (patients with both melanoma diagnosis and death in 2003–2008), we compared the observed melanoma mortality of the SCREEN cohort to the melanoma mortality expected without screening in the general population of Saarland. Results The age- and sex-standardized melanoma mortality ratio (SMR) for 5.5 years of follow-up was 0.59 (95% confidence interval, 0.40–0.83). Conclusion Our results indicate reduced mortality in the SCREEN cohort. Several potential biases cannot be excluded, but most of them tend to inflate the SMR. [ABSTRACT FROM AUTHOR]

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Introduction: The advent of tyrosine kinase inhibitors has produced 5-year survival of 90 + % for chronic myelocytic leukemia (CML) patients in clinical trials. However, population level survival has been lower, especially in older patients. Here, we examine survival of patients with CML in Germany and compare it to survival of patients in the United States (US). Methods: Data were extracted from the Surveillance, Epidemiology, and End Results database in the US and 11 cancer registries in Germany. Patients 15-69 years old diagnosed with CML were included in the analysis. Period analysis for 2002-2006 was used to provide the most up-to-date possible estimates of five-year relative survival. Results: Five-year relative survival was 68.7% overall in Germany and 72.7% in the US. Survival was higher in the US for all age groups except for ages 15-39 years, but the difference was only statistically significant for ages 50- 59 years (at 67.5% vs 77.7% in Germany and the US, respectively). Survival decreased with age, ranging from 83.1% and 81.9%, respectively, in Germany and the US for patients 15-39 years old to 54.2% and 54.5%, respectively, in patients 65-69 years old. Survival increased between 2002 and 2006 by 12.0% points in Germany and 17.1% points in the US. Conclusions: Five-year survival estimates were higher in the US than in Germany overall, but the difference was only significant for ages 50-59 years. Survival did not equal that seen in clinical trials for either country, but strong improvement in survival was seen between 2002 and 2006. [ABSTRACT FROM AUTHOR]

Background: Infection with human papillomavirus (HPV) is one of the more common sexually transmitted diseases in Germany. Vaccination against HPV was introduced in Germany in 2007. In this study, we sought to detect a population-based decline in the incidence of cervical cancer in women under age 30 who were eligible for vaccination in the first 11 years after its introduction., Methods: Data on new diagnoses of HPV-associated cervical cancer from 2004 to 2018 were obtained from the cancer registries of the German federal states (Bundesländer) through the German Center for Cancer Registry Data (ZfKD). Trends in the incidence of invasive and in situ cervical cancer were determined with log-linear joinpoint regression and age-period-cohort models., Results: The incidence of cervical cancer, which had been rising in the previous decades, has been falling since 2010, with a marked decline among women in all age groups eligible for vaccination (e.g., from 70.0 to 41.8 cases per 100 000 persons per year from 2010 to 2018 in women aged 24 to 26). Women born in 1992 were the first to become eligible for vaccination and have a 24% lower incidence than the reference cohort of women born in 1989 (relative risk 0.76, 95% confidence interval [0.68; 0.86]). Larger effects were found in later birth cohorts, in which vaccination was more widespread., Conclusion: Eleven years after the introduction of HPV vaccination, a drop in the incidence of cervical cancer was observable at the population level in the birth cohorts eligible for vaccination.

Background: The introduction of continuous glucose monitoring (CGM) implies new challenges for diabetes care. As CGM systems are often directly linked to a web-based software solution, structured telemedicine care using a video-consultation may be a new option for families who care for children with type 1 diabetes mellitus (T1DM)., Methods: "ViDiKi" (Virtual Diabetes Outpatient Clinic for Children and Youth) is a multicenter controlled trial carried out in Northern Germany. ViDiKi will examine if monthly telemedical consultations, in addition to regular care, will improve glycemic control and psychosocial outcomes. The primary outcome is glycemic control as measured by a change in glycated hemoglobin (HbA1c). A total of 240 participants aged between one year and 16 years using a CGM with multiple daily injections (MDI) or insulin pump therapy were recruited and assigned to a starter group or a six-month waiting control group. The sample size is designed to detect a between-group difference of 0.5% in HbA1c change at six months. Secondary outcomes are variability of blood glucose, health-related quality of life, self-efficacy, and satisfaction with telemedicine. To gain deeper insight into the experience of using telemedicine, qualitative interviews will be conducted. In a health-economic analysis, the costs of telemedicine and a cost-of-care analysis will be calculated., Conclusions: The results from the ViDiKi study shall give important information on the feasibility and putative benefits of telemedicine in children with T1DM and their caregivers., German Clinical Trails Register (drks): DRKS00012645.