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1.
Article in German | MEDLINE | ID: mdl-37815611

ABSTRACT

Newborn screening from dried blood spots (NBS) is a highly effective secondary prevention measure that has been established for many years. Against the background of the inclusion of "new diseases" that meet the screening criteria, a concept for the further advancement of NBS was developed on behalf of the GKV-Spitzenverband. This was based on a systematic literature review and a survey of the status quo of NBS in Germany using quantitative and qualitative methods.It is essential for the success of NBS that all newborns affected by a target disease are diagnosed and treated at an early stage and that the harm to be expected with each screening (e.g., due to false positive findings) is kept as low as possible. This requires the organisation of screening in the sense of an integrated programme through central coordination with standardised structures, continuous quality management and digitalisation in line with data protection requirements.Although in general NBS is being implemented successfully in Germany, the research project presented here also reveals weaknesses and a need for action. Proposals and recommendations were compiled in a concept paper, which shows approaches for further development of NBS in line with the current state of research in consideration of changing demands on the infrastructure and processes in the health system. This review article summarises the challenges, current status and possible solutions for the central topics of the concept paper.


Subject(s)
Neonatal Screening , Total Quality Management , Humans , Infant, Newborn , Germany , Neonatal Screening/methods , Systematic Reviews as Topic
2.
Article in German | MEDLINE | ID: mdl-37843595

ABSTRACT

BACKGROUND: Newborn hearing screening (NHS) was introduced nationwide by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G­BA) in 2009. In this process, quality targets were also set in the pediatrics directive. In order to review the quality NHS in Germany, the G­BA commissioned a consortium to conduct an initial evaluation for the years 2011 and 2012 and a follow-up evaluation for 2017 and 2018. METHODS: The evaluations were based on NHS screening parameters (Sammelstatistiken) that must be documented by all obstetrics and neonatology departments as NHS providers and can also be compiled through cooperation with hearing screening centers (HSCs). Additional data were collected through questionnaires and interviews and routine data were used to evaluate the screening process. RESULTS: In 13 federal states, a total of 15 HSCs are involved in the screening process. Across Germany, an NHS screening rate of 86.1% was documented in 2018 (82.4% in 2012), but this differed significantly between the federal states. The specified quality targets could not yet be implemented everywhere. For example, only less than half of the obstetric departments achieved the specified screening rate of over 95%. A comparison of data from the follow-up evaluation and the first evaluation showed that the structural quality of NHS had improved, while the process quality remained the same or had deteriorated. The refer rate (children who were discharged without passing the screening) increased from 5.3% to 6.0%. DISCUSSION: To improve the quality of NHS, HSCs should be established nationwide and a second screening should be carried out more consistently before discharge in the case of a refer result in the initial screening.


Subject(s)
Hearing , Neonatal Screening , Infant, Newborn , Humans , Child , Germany , Neonatal Screening/methods
4.
J Inherit Metab Dis ; 46(6): 1043-1062, 2023 11.
Article in English | MEDLINE | ID: mdl-37603033

ABSTRACT

Analytical and therapeutic innovations led to a continuous but variable extension of newborn screening (NBS) programmes worldwide. Every extension requires a careful evaluation of feasibility, diagnostic (process) quality and possible health benefits to balance benefits and limitations. The aim of this study was to evaluate the suitability of 18 candidate diseases for inclusion in NBS programmes. Utilising tandem mass spectrometry as well as establishing specific diagnostic pathways with second-tier analyses, three German NBS centres designed and conducted an evaluation study for 18 candidate diseases, all of them inherited metabolic diseases. In total, 1 777 264 NBS samples were analysed. Overall, 441 positive NBS results were reported resulting in 68 confirmed diagnoses, 373 false-positive cases and an estimated cumulative prevalence of approximately 1 in 26 000 newborns. The positive predictive value ranged from 0.07 (carnitine transporter defect) to 0.67 (HMG-CoA lyase deficiency). Three individuals were missed and 14 individuals (21%) developed symptoms before the positive NBS results were reported. The majority of tested candidate diseases were found to be suitable for inclusion in NBS programmes, while multiple acyl-CoA dehydrogenase deficiency, isolated methylmalonic acidurias, propionic acidemia and malonyl-CoA decarboxylase deficiency showed some and carnitine transporter defect significant limitations. Evaluation studies are an important tool to assess the potential benefits and limitations of expanding NBS programmes to new diseases.


Subject(s)
Metabolism, Inborn Errors , Propionic Acidemia , Humans , Infant, Newborn , Neonatal Screening/methods , Metabolism, Inborn Errors/diagnosis , Metabolism, Inborn Errors/epidemiology , Tandem Mass Spectrometry/methods , Carnitine/metabolism
5.
Int J Neonatal Screen ; 9(3)2023 Jun 22.
Article in English | MEDLINE | ID: mdl-37489488

ABSTRACT

Newborn screening using dried blood spots (NBS) is widely acknowledged as a highly successful procedure in secondary prevention. For a number of congenital disorders, severe disability or death are impressively prevented by early detection and early treatment through NBS. However, as with any other screening, NBS can also cause harm, and the principle that "the overall benefits of screening should outweigh the harms" must be considered when introducing and implementing NBS programmes. This publication compiles the results of a systematic literature research on requirements for NBS infrastructure and procedures which was conducted as part of a research project on the quality and shortcomings of the NBS pathway in Germany. The compilation contains the requirements and recommendations for realising the principle of "maximise benefits and minimise harms" in relevant NBS pathway components such as parental education and information, coverage, timeliness, laboratory quality assurance, follow-up of abnormal results, confirmatory diagnostics, documentation, and evaluation. The results reflect the complexity of NBS infrastructure, and thus, they illustrate the importance of considering and implementing NBS as a well-coordinated public health programme with continuous quality management. Special attention should be paid to the perspectives of parents and families. Some NBS issues can substantially benefit from digital instruments or international cooperation. The literature review presented here has contributed to a concept of proposals for the advancement of NBS in Germany, and despite different settings, it may as well be of interest for other countries to achieve the best possible course and outcome of NBS for each child.

6.
J Clin Immunol ; 43(5): 965-978, 2023 07.
Article in English | MEDLINE | ID: mdl-36843153

ABSTRACT

BACKGR OUND: T-cell receptor excision circle (TREC)-based newborn screening (NBS) for severe combined immunodeficiencies (SCID) was introduced in Germany in August 2019. METHODS: Children with abnormal TREC-NBS were referred to a newly established network of Combined Immunodeficiency (CID) Clinics and Centers. The Working Group for Pediatric Immunology (API) and German Society for Newborn Screening (DGNS) performed 6-monthly surveys to assess the TREC-NBS process after 2.5 years. RESULTS: Among 1.9 million screened newborns, 88 patients with congenital T-cell lymphocytopenia were identified (25 SCID, 17 leaky SCID/Omenn syndrome (OS)/idiopathic T-cell lymphocytopenia, and 46 syndromic disorders). A genetic diagnosis was established in 88%. Twenty-six patients underwent hematopoietic stem cell transplantation (HSCT), 23/26 within 4 months of life. Of these, 25/26 (96%) were alive at last follow-up. Two patients presented with in utero onset OS and died after birth. Five patients with syndromic disorders underwent thymus transplantation. Eight syndromic patients deceased, all from non-immunological complications. TREC-NBS missed one patient, who later presented clinically, and one tracking failure occurred after an inconclusive screening result. CONCLUSION: The German TREC-NBS represents the largest European SCID screening at this point. The incidence of SCID/leaky SCID/OS in Germany is approximately 1:54,000, very similar to previous observations from North American and European regions and countries where TREC-NBS was implemented. The newly founded API-CID network facilitates tracking and treatment of identified patients. Short-term HSCT outcome was excellent, but NBS and transplant registries will remain essential to evaluate the long-term outcome and to compare results across the rising numbers of TREC-NBS programs across Europe.


Subject(s)
Lymphopenia , Severe Combined Immunodeficiency , Child , Infant, Newborn , Humans , Neonatal Screening/methods , Severe Combined Immunodeficiency/diagnosis , Severe Combined Immunodeficiency/epidemiology , Severe Combined Immunodeficiency/therapy , Prospective Studies , Lymphopenia/diagnosis , DNA , Germany/epidemiology , Receptors, Antigen, T-Cell/genetics
7.
Article in German | MEDLINE | ID: mdl-36648498

ABSTRACT

During the SARS-CoV­2 pandemic, various data had to be collected to support political decisions for pandemic preparedness and response. Nevertheless, using analogue tools like paper and pencil as well as sending files with media discontinuity that have to be merged later are not useful and can hardly provide usable data in real time. With the selected system architecture, the Bavarian Online Database for Corona Screening Tests (BayCoRei) is a central, Bavaria-wide, consistent digital solution that is agile and easy to use. BayCoRei uses established technical components and interfaces. Apart from this, the support of the individual stakeholders (e.g., health authorities, service providers, and district governments) plays a decisive role in the success of the solution. The present article describes BayCoRei and two other online databases as examples that comprise the technology and architecture that have proven to be (rapidly) deployable and points out the gap between intention and reality regarding pandemic management.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , COVID-19/epidemiology , Pandemics/prevention & control , Germany
8.
Pediatr Pulmonol ; 58(3): 844-852, 2023 03.
Article in English | MEDLINE | ID: mdl-36444714

ABSTRACT

PURPOSE: Cystic fibrosis (CF) was added to the German newborn bloodspot screening (NBS) panel in 2016. This study assesses parental perceptions of CF-NBS and confirmatory testing. METHODS: Prospective questionnaire-based survey administered to parents of children with positive CF-NBS over 40 months after initiation of CF-NBS in Southwest Germany. Parental perceptions were compared to results from Bavaria and Switzerland. RESULTS: Questionnaires with 29 standardized questions were sent to 343 families with children born between October 2016 and January 2020. A total of 178 (51.9%) replied. Although required by law, only a minority were informed about CF-NBS by a physician. The information provided about NBS was sufficient for 78% of parents. Regarding the information about positive CF-NBS, 52.9% were satisfied but the majority expressed negative emotions (89.5%). While most of these were resolved after confirmatory diagnostics, 17% of parents of children with false-positive CF-NBS and 66.7% of children confirmed with CF remained anxious. Waiting time for sweat testing was >3 days in 56.1%, considerably longer than in more centralized screening systems. Parents who waited for a maximum of 3 days were significantly more satisfied. 70.7% of parents were satisfied with the information given during confirmatory diagnostics and 91.4% were satisfied with participating in CF-NBS. CONCLUSIONS: CF-NBS stands in high regard with parents. Smooth organization, timely initiation of confirmatory testing, and professional communication are most important to limit parental anxiety. A more centralized system of confirmatory diagnostics appears advantageous in several regards as it reduces time from positive NBS to final diagnosis and increases parental satisfaction.


Subject(s)
Cystic Fibrosis , Neonatal Screening , Infant, Newborn , Child , Humans , Neonatal Screening/methods , Cystic Fibrosis/diagnosis , Cystic Fibrosis/psychology , Prospective Studies , Anxiety , Parents/psychology
9.
J Neuromuscul Dis ; 10(1): 55-65, 2023.
Article in English | MEDLINE | ID: mdl-36463459

ABSTRACT

Now that targeted therapies for spinal muscular atrophy are available, attempts are being made worldwide to include screening for spinal muscular atrophy in general newborn screening. In Germany, after pilot projects from 2018-2021, it was included in the general newborn screening from October 2021. To ensure a smooth transition, criteria for follow-up were developed together with key stakeholders. At the beginning of the transition to nationwide screening, false positive findings were reported in 3 patients. After optimization of the screening method in the laboratories concerned, all findings have been subsequently confirmed. On average, the first presentation to a neuromuscular center occurred on day 12 of life, and in patients with 2 or 3 SMN2 copies, therapy started on day 26 of life. Compared with the pilot project, there was no significant delay in timing.


Subject(s)
Muscular Atrophy, Spinal , Infant, Newborn , Humans , Pilot Projects , Muscular Atrophy, Spinal/diagnosis , Muscular Atrophy, Spinal/epidemiology , Muscular Atrophy, Spinal/therapy , Neonatal Screening/methods , Germany , Time
10.
BMC Med ; 20(1): 156, 2022 04 14.
Article in English | MEDLINE | ID: mdl-35418073

ABSTRACT

BACKGROUND: Obesity in pregnancy and related early-life factors place the offspring at the highest risk of being overweight. Despite convincing evidence on these associations, there is an unmet public health need to identify "high-risk" offspring by predicting very early deviations in weight gain patterns as a subclinical stage towards overweight. However, data and methods for individual risk prediction are lacking. We aimed to identify those infants exposed to obesity in pregnancy at ages 3 months, 1 year, and 2 years who likely will follow a higher-than-normal body mass index (BMI) growth trajectory towards manifest overweight by developing an early-risk quantification system. METHODS: This study uses data from the prospective mother-child cohort study Programming of Enhanced Adiposity Risk in CHildhood-Early Screening (PEACHES) comprising 1671 mothers with pre-conception obesity and without (controls) and their offspring. Exposures were pre- and postnatal risks documented in patient-held maternal and child health records. The main outcome was a "higher-than-normal BMI growth pattern" preceding overweight, defined as BMI z-score >1 SD (i.e., World Health Organization [WHO] cut-off "at risk of overweight") at least twice during consecutive offspring growth periods between age 6 months and 5 years. The independent cohort PErinatal Prevention of Obesity (PEPO) comprising 11,730 mother-child pairs recruited close to school entry (around age 6 years) was available for data validation. Cluster analysis and sequential prediction modelling were performed. RESULTS: Data of 1557 PEACHES mother-child pairs and the validation cohort were analyzed comprising more than 50,000 offspring BMI measurements. More than 1-in-5 offspring exposed to obesity in pregnancy belonged to an upper BMI z-score cluster as a distinct pattern of BMI development (above the cut-off of 1 SD) from the first months of life onwards resulting in preschool overweight/obesity (age 5 years: odds ratio [OR] 16.13; 95% confidence interval [CI] 9.98-26.05). Contributing early-life factors including excessive weight gain (OR 2.08; 95% CI 1.25-3.45) and smoking (OR 1.94; 95% CI 1.27-2.95) in pregnancy were instrumental in predicting a "higher-than-normal BMI growth pattern" at age 3 months and re-evaluating the risk at ages 1 year and 2 years (area under the receiver operating characteristic [AUROC] 0.69-0.79, sensitivity 70.7-76.0%, specificity 64.7-78.1%). External validation of prediction models demonstrated adequate predictive performances. CONCLUSIONS: We devised a novel sequential strategy of individual prediction and re-evaluation of a higher-than-normal weight gain in "high-risk" infants well before developing overweight to guide decision-making. The strategy holds promise to elaborate interventions in an early preventive manner for integration in systems of well-child care.


Subject(s)
Obesity, Maternal , Pediatric Obesity , Body Mass Index , Child , Child, Preschool , Cohort Studies , Female , Humans , Infant , Longitudinal Studies , Overweight/epidemiology , Pediatric Obesity/diagnosis , Pediatric Obesity/epidemiology , Pediatric Obesity/prevention & control , Pregnancy , Prospective Studies , Weight Gain
11.
Eur J Pediatr ; 181(6): 2415-2422, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35294644

ABSTRACT

Medium-chain acyl-coenzyme A dehydrogenase (MCAD) deficiency is the most common disorder of mitochondrial ß-oxidation of fatty acids resulting in hypoketotic hypoglycemia, hepatopathy, and often fatal outcome in undiagnosed children. Introduction of tandem mass spectrometry-based newborn screening programs in the late 1990s has significantly reduced morbidity and mortality in MCAD deficiency; however, neonatal death in individuals with early disease manifestation and severe hypoglycemia may still occur. We describe the fatal disease course in eight newborns with MCAD deficiency, aiming to raise awareness for early clinical symptoms and the life-saving treatment, and promote systematic post-mortem protocols for biochemical and genetic testing, necessary for correct diagnosis and counselling of the family if unexpected death occurred in the neonatal period.Conclusion: Early newborn screening and awareness for clinical symptoms is lifesaving in MCAD deficiency, which may present with fatal neonatal crisis. Systematic post-mortem diagnostic protocols are needed for sudden neonatal deaths.


Subject(s)
Hypoglycemia , Lipid Metabolism, Inborn Errors , Perinatal Death , Acyl-CoA Dehydrogenase/deficiency , Female , Humans , Infant, Newborn , Lipid Metabolism, Inborn Errors/complications , Lipid Metabolism, Inborn Errors/diagnosis , Neonatal Screening/methods
12.
J Asthma ; 59(7): 1343-1352, 2022 07.
Article in English | MEDLINE | ID: mdl-33998939

ABSTRACT

Introduction: Asthma is among the most common chronic conditions in children. The aim of this publication is to describe prevalence rates and factors associated with asthmatic or wheezing preschoolers and to evaluate medical care and treatment with regard to urban-rural differences.Methods: Data for this cross-sectional study were collected through a questionnaire, which was distributed to parents within the Health Monitoring Units in Bavaria (HMU), Germany. Data from 4767 children were available (2016/17). Those children were classified into four diagnostic groups: Unremitting Wheeze, International Study of Asthma and Allergies in Children (ISAAC) Asthma, Physician-diagnosed Asthma, and healthy control group. Urban-rural differences were tested by Pearson's chi-squared test or by Fisher's exact test. Independent variables were factors associated with health outcomes, for example, residency or migrant status. To examine associations between independent and outcome variables multivariate logistic regression analysis was performed.Results: Prevalence rates were 6.3% for 'Unremitting Wheeze', 5.2% for 'ISAAC Asthma', and 1.2% for 'Physician-diagnosed Asthma'. Factors associated with health outcomes were the occurrence of asthma in first-degree relatives, male sex, and migrant status. Generally, higher rates of doctor's visits, positive allergy tests, and corticosteroids intake in the diagnostic groups in rural compared to urban areas were observed. Rates of performed allergy tests were 55.6% for 'ISAAC Asthma' and 74.6% for 'Physician-diagnosed Asthma'.Conclusions: Prevalence rates of the diagnostic groups decreased compared to the HMU 2014/15. According to previous studies, factors associated with asthmatic or wheezing health outcomes could be confirmed. Children in rural areas generally received more medical care.Key pointsChildren's prevalence rates of asthma or wheezing disorders decreased in the past 2 years within Bavaria.This study is consistent with risk factors for asthma from the literature: asthma in the family, male gender, and migrant status.Children in rural areas receive more medical care than children in urban areas.There should me more allergy tests among children with medical diagnosis in Bavaria as low rates indicate gaps in care.


Subject(s)
Asthma , Hypersensitivity , Asthma/diagnosis , Asthma/epidemiology , Asthma/therapy , Child , Cross-Sectional Studies , Humans , Hypersensitivity/complications , Male , Outcome Assessment, Health Care , Prevalence , Respiratory Sounds/diagnosis , Risk Factors , Surveys and Questionnaires
13.
Nervenarzt ; 93(2): 135-141, 2022 Feb.
Article in German | MEDLINE | ID: mdl-34652481

ABSTRACT

BACKGROUND: The introduction of a comprehensive newborn screening program for spinal muscular atrophy (SMA), specifically for 5q-SMA, is planned for the end of 2021 in Germany. Several targeted treatment options have become available for all patients with SMA. MATERIAL AND METHODS: Newborn screening for 5q-SMA is based on the detection of a homozygous deletion of exon 7 in the SMN1 gene by molecular genetic analysis from the dried blood card. In all cases a second blood sample must be drawn as a part of confirmation diagnostics including the determination of the SMN2 copy numbers. RESULTS: Insights from pilot projects performed in parts of Germany are presented. Advantages and disadvantages of the screening project are discussed. CONCLUSION: Consultation and treatment should be carried out in a department of neuropediatrics with experience in the treatment of children with 5q-SMA, which is able to provide all current treatment options for the child, so that, when necessary, the treatment can be started within the first month of life.


Subject(s)
Muscular Atrophy, Spinal , Neonatal Screening , Child , Exons , Homozygote , Humans , Infant, Newborn , Muscular Atrophy, Spinal/diagnosis , Muscular Atrophy, Spinal/genetics , Muscular Atrophy, Spinal/therapy , Sequence Deletion
14.
Gesundheitswesen ; 84(2): 117-125, 2022 Feb.
Article in German | MEDLINE | ID: mdl-33951738

ABSTRACT

BACKGROUND: The aim of the newborn hearing screening (NHS) is to identify and treat children with bilateral hearing disorders early. The NHS is regulated in Germany by the Pediatric Directive, which recommends an evaluation after 5 years. This evaluation was performed for the first time nationwide for children born between 2011 and 2012 regarding structural, process and result quality. OBJECTIVES: Challenges in the collection of appropriate data as basis for evaluation are described and possible improvements are suggested. METHODS: All maternity and neonatology wards performing the NHS were identified and their documentations of the NHS analysed. In addition, all pediatric audiologists were identified to gather data on children with bilateral permanent congenital hearing disorder. RESULTS: The identification of relevant maternity and neonatology wards was very burdensome. More than half of them were not aware that NHS had to be documented. There was no documentation on more than 15% of the children that were to be screened. Furthermore, data concerning bilateral congenital hearing disorders was only accessible for 60% of the expected number of affected children. CONCLUSIONS: Data required for the evaluation of the NHS regarding structural, process and result quality were incomplete and missing. The database for evaluations should be defined precisely and structures needed to obtain meaningful results have to be established in advance. Nevertheless, the evaluation of the NHS provides meaningful results concerning the screening process in Germany.


Subject(s)
Hearing Tests , Neonatal Screening , Child , Female , Germany/epidemiology , Hearing , Hearing Disorders/diagnosis , Hearing Disorders/epidemiology , Hospitals , Humans , Infant, Newborn , Pregnancy
16.
BMC Public Health ; 21(1): 2134, 2021 11 20.
Article in English | MEDLINE | ID: mdl-34801027

ABSTRACT

BACKGROUND: Concerns about smoking displacement from public places to private amenities aroused following smoking ban implementation in Bavaria in 2008. We analysed children's exposure to second-hand smoke (SHS) before and after the ban, its effect on children's health and prevalence of active smoking in adults. METHODS: Six cross-sectional surveys (n = 32,443) on pre-school children in Bavaria were analysed, two surveys before the smoking ban in years 2004 and 2005 (S1 and S2) and four after the ban in 2008, 2012, 2014 and 2016 (S4, S6, S7 and S8). Using multivariable logistic regression, we analysed change in children's intra- and extrauterine SHS exposure and its adverse health effects (Asthma, wheezing, bronchitis and neurodermatitis) as well as change in parental active smoking. RESULTS: The response rates were 78% for S1, 73% for S2, 61% for S4, 62% for S6, 56% for S7 and 54% for S8. Odds of parents never smoked at home in presence of children increased significantly from before to after the ban with odds ratios (OR) 1.17 (CI95% 1.01-1.35), 1.65 (CI95% 1.39-1.95), 2.85 (CI95% 2.32-3.51), 2.24 (CI95% 1.84-2.72) and 3.66 (CI95% 2.89-4.63) for S2, S4, S6, S7 and S8, respectively with S1 as reference. Compared to S4, odds of parents who were not actively smoking is significantly higher in S7 (OR = 1.13 (CI95% 1.03-1.24)) and S8 (OR = 1.24 (CI95% 1.13-1.36)). The odds of mothers who never smoked during pregnancy increased over time with OR = 1.22 (CI95% 1.06-1.40) for S2 and 1.57 (CI95% 1.33-1.86) for S8 compared to S1. Adverse health effects related to children's exposure to SHS are significantly less in S8 compared to S1. CONCLUSION: After 11 years of smoking ban in Bavaria, smoking displacement to homes was disproved. Exposure of children to SHS intrauterine and at home is decreasing. Number of parents who are not actively smoking is increasing over time. Prevalence of health problems in children related to exposure to SHS is decreasing.


Subject(s)
Smoke-Free Policy , Tobacco Smoke Pollution , Adult , Child , Child Health , Child, Preschool , Cross-Sectional Studies , Environmental Exposure/analysis , Environmental Exposure/statistics & numerical data , Female , Humans , Parents , Smoking/epidemiology , Tobacco Smoke Pollution/adverse effects , Tobacco Smoke Pollution/statistics & numerical data
17.
PLoS One ; 16(11): e0259370, 2021.
Article in English | MEDLINE | ID: mdl-34739520

ABSTRACT

BACKGROUND: The efficacy of the BioNTech-Pfizer BNT162b2 vaccination in the elderly (≥80 years) could not be fully assessed in the BioNTech-Pfizer trial due to low numbers in this age group. We aimed to evaluate the effectiveness of the BioNTech-Pfizer (BNT162b2) vaccine to prevent SARS-CoV-2 infection and severe outcomes in octo- and novo-generians in a German state setting. METHODS AND FINDINGS: A prospective observational study of 708,187 persons aged ≥80 years living in Bavaria, Germany, was conducted between Jan 9 to Apr 11, 2021. We assessed the vaccine effectiveness (VE) for two doses of the BNT162b2 vaccine with respect to SARS-CoV-2 infection and related hospitalisations and mortality. Additionally, differences in VE by age groups ≥80 to ≤89 years and ≥90 years were studied. Analyses were adjusted by sex. By the end of follow-up, 63.8% of the Bavarian population ≥80 years had received one dose, and 52.7% two doses, of the BNT162b2 vaccine. Two doses of the BNT162b2 vaccine lowered the proportion of SARS-CoV-2 infections and related outcomes, resulting in VE estimates of 68.3% (95% confidence interval (CI) 65.5%, 70.9%) for infection, 73.2% (95% CI 65.3%, 79.3%) for hospitalisation, and 85.1% (95% CI 80.0%, 89.0%) for mortality. Sex differences in the risk of COVID-19 outcomes observed among unvaccinated persons disappeared after two BNT162b2 vaccine doses. Overall, the BNT162b2 vaccine was equally effective in octo- and novo-genarians. CONCLUSIONS: Two doses of BioNTech-Pfizer's BNT162b2 vaccine is highly effective against COVID-19 outcomes in elderly persons.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Age Factors , Aged , Aged, 80 and over , BNT162 Vaccine , Female , Germany/epidemiology , Hospitalization , Humans , Immunization Programs , Male , Prospective Studies , SARS-CoV-2 , Sex Factors , Treatment Outcome , Vaccination
18.
Int J Neonatal Screen ; 7(4)2021 Oct 13.
Article in English | MEDLINE | ID: mdl-34698071

ABSTRACT

After several decades of successful newborn screening (NBS) for congenital hypothyroidism, the optimal hypothyroidism NBS algorithm for very preterm infants is still controversial. Due to concerns about an elevated risk of a false-negative initial thyroid-stimulation hormone (TSH) screening, repeat NBS has been implemented for this group. While transient hypothyroidism is known to be more frequent among very preterm infants, the prevalence of permanent hypothyroidism is generally assumed to be the same as in more mature newborns. This study analyses screening and long-term follow-up data from the population-based cohort of 51 infants born from 1999-2017 at less than 32 weeks of gestation and diagnosed with hypothyroidism after NBS in the German Federal State of Bavaria (total number of infants screened 2,107,864). Severe permanent hypothyroidism was always detected at initial TSH screening unless there was a known confounding factor. Cases detected by repeat screening after a negative initial screen most frequently proved to be transient, less frequently mild permanent, or a definitive diagnosis was not possible because of inadequate re-evaluation of the thyroid axis. The prevalence of both permanent and transient hypothyroidism was elevated compared to a cohort of children from the same region born at a higher gestational age. The results seem to support the need for the repeated NBS of very preterm infants. However, as the recommendation to treat mild hypothyroidism is not based on high quality evidence, important issues for future research include treatment outcome studies or even a general review of whether this diagnosis meets the screening criteria. Meanwhile, involving a paediatric endocrinologist in treatment decisions is crucial for optimising the benefit of hypothyroidism screening for this particularly vulnerable group.

19.
Dtsch Arztebl Int ; 118(27-28): 486, 2021 07 12.
Article in English | MEDLINE | ID: mdl-34491164

Subject(s)
Adult , Humans
20.
Eur J Public Health ; 31(4): 770-775, 2021 10 11.
Article in English | MEDLINE | ID: mdl-34436561

ABSTRACT

BACKGROUND: Atopic diseases are among the most common chronic conditions in childhood. Causes of allergies are manifold. The aim of this paper is to evaluate risk factors for atopic diseases and unremitting wheeze and to examine if there is an association between measles, mumps and rubella (MMR) vaccination and atopic dermatitis, asthma and unremitting wheeze in Bavarian pre-schoolers. METHODS: Parents filled out a questionnaire on children's health and environmental and socioeconomic factors. The questionnaire was administered within the Health Monitoring Units in a cross-sectional study in Bavaria, Germany (2014/2015). Data on vaccinations were obtained via the School Entrance Examination, a mandatory examination for pre-school children in Bavaria. Rates of influential factors of atopic diseases and wheeze, MMR and DTP (diphtheria, pertussis and tetanus) vaccination were calculated for all children stratified by health outcomes. To examine if there is an association between MMR vaccination and health outcomes, a multiple logistic regression analysis was performed. RESULTS: Data were available for 3237 individuals. Symptoms and diseases were more frequent in boys. Higher parental education was associated with a higher prevalence of atopic dermatitis. There were no significant associations between any of the health outcome groups and MMR vaccination in the multiple logistic regression models with adjustment for potential confounders. CONCLUSIONS: The present study is in line with the current state of research that MMR vaccination is not associated with atopic diseases.


Subject(s)
Mumps , Rubella , Child , Cross-Sectional Studies , Humans , Immunization , Male , Measles-Mumps-Rubella Vaccine , Vaccination
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