Do Patients with Luminal A Breast Cancer Profit from Adjuvant Systemic Therapy? A Retrospective Multicenter Study

Background Luminal A breast cancers respond well to anti-hormonal therapy (HT), are associated with a generally favorable prognosis and constitute the majority of breast cancer subtypes. HT is the mainstay of treatment of these patients, accompanied by an acceptable profile of side effects, whereas the added benefit of chemotherapy (CHT), including anthracycline and taxane-based programs, is less clear-cut and has undergone a process of critical revision. Methods In the framework of the BRENDA collective, we analyzed the benefits of CHT compared to HT in 4570 luminal A patients (pts) with primary diagnosis between 2001 and 2008. The results were adjusted by nodal status, age, tumor size and…

Epidemiologie und Molekulare Epidemiologie

The Role of Epidemiology in Cancer Risk Assessment of Nonionizing Radiation

Statistical power of disease cluster and clustering tests for rare diseases: A simulation study of point sources

Abstract Two recent epidemiological studies on clustering of childhood leukemia showed different results on the statistical power of disease cluster and clustering tests, possibly an effect of spatial data aggregation. Eight different leukemia cluster scenarios were simulated using individual addresses of all 1,009,332 children living in Denmark in 2006. For each scenario, a number of point sources were defined with an increased risk ratio at centroid, decreasing linearly to 1.0 at the edge; aggregation levels were administrative units of Danish municipalities and squares of 5, 12.5 and 25 km 2 . Six statistical methods were compared. Generally, statistical power decreased with increasing s…

Analysis of risk factors for neurological dysfunction in patients with acute aortic dissection type A: data from the German Registry for Acute Aortic Dissection Type A (GERAADA)

OBJECTIVES: Acute aortic dissection type A (AADA) is associated with major adverse events, such as transient or persistent neurological dysfunction (ND), which may be patient-, disease- or surgery-related. There is a lack of consensus regarding risk factors for ND in AADA patients. The aim of this study was to analyse and identify risk factors for new postoperative ND after aortic repair for AADA. METHODS: Between July 2006 and June 2010, 2137 AADA patients were enrolled in the multi-centre, prospective German Registry of AADA (GERAADA). Perioperative data were prospectively gathered from 50 institutes in Austria, Switzerland and Germany, and multivariate logistic regression analysis was pe…

Colorectal cancer stage at diagnosis in migrants versus non-migrants (KoMigra) : study protocol of a cross-sectional study in Germany

Background: In Germany, about 20% of the total population have a migration background. Differences exist between migrants and non-migrants in terms of health care access and utilisation. Colorectal cancer is the second most common malignant tumour in Germany, and incidence, staging and survival chances depend, amongst other things, on ethnicity and lifestyle. The current study investigates whether stage at diagnosis differs between migrants and non-migrants with colorectal cancer in an area of high migration and attempts to identify factors that can explain any differences. Methods/Design: Data on tumour and migration status will be collected for 1,200 consecutive patients that have receive…

Coagulation and inflammation in long‐term cancer survivors: results from the adult population

Essentials The increase of cancer survival remains curtailed by cardiovascular mortality. We studied a large range of inflammatory and coagulation biomarkers in long-term cancer survivors. Cancer history has an important impact on mortality independent of cardiovascular risk factors. Fibrinogen and von Willebrand factor are potential biomarkers in survivors of increased mortality. Summary Background The advances in cancer treatment and detection of early cancer have resulted in a steady increase in the number of of cancer survivors over the years. However, because of the long-term toxic effects of chemotherapy and radiotherapy, the incidence of cardiovascular disease (CVD) is increasing in …

Correction: Validation of Semantic Analyses of Unstructured Medical Data for Research Purposes.

Wichtige epidemiologische Studientypen

The effect of exposure to radiofrequency fields on cancer risk in the general and working population: A protocol for a systematic review of human observational studies

Highlights • RF-EMF was classified by IARC as possibly carcinogenic to humans (2B) in May 2011 • A systematic review of all subject-relevant epidemiological studies is now needed. • A detailed protocol ensures the review's transparency, utility and credibility. • Original study validity will be evaluated with a customized OHAT risk of bias tool. • Internal coherence and external plausibility will inform conclusions.

Emerging aspects of mobile phone use

The mobile phone is a modern-day invention, which has managed to reach many parts of the world enabling telecommunications across areas where it was not possible before. Although these devices have proved to be life saving in certain circumstances (e.g., after accidents) and helped improve the quality of life in some sectors, concerns continue to be raised about potential adverse health impacts associated with their use. These range from cancer and cognitive deficiencies to subjective effects, such as a feeling of warmth around the ear used, headache and fatigue. We provide an overview of the concerns raised and summarise what is known about them. We conducted a literature search in Pubmed/…

Temporal trends in the incidence rate of childhood cancer in Germany 1987-2004.

The German Childhood Cancer Registry regularly presents graphs of childhood cancer incidence rates by period, but no systematic analysis. The Automated Childhood Cancer Information System-project found an increasing trend in Europe. Against this background we present the first detailed trend analysis of childhood (aged under 15) malignancies in Germany. We examined incidence rates separately in western Germany 1987-2004 and eastern Germany 1991-2004. We analyzed all malignancies, all main diagnostic groups and relevant subsets using an age-period-cohort model. Additionally we fitted fractional polynomials to assess the linearity of the drift. All malignancies combined (excluding Central Ner…

Comparison of Studies on Mobile Phone Use and Risk of Tumors

published results of ameta-analysis of studies on mobile phone use and risk of tumors. Intheir analysis, the authors included 23 case-control studies, covering abroad spectrum of tumor entities including uveal melanoma, testicu-lar cancer, parotid gland tumors, and brain tumors.However, the authors give no rationale for pooling these hetero-geneous, biologically rather diverse cancer sites, for which the local-ized exposure from the use of mobile phones is completely different.The key difference between this particular meta-analysis com-pared with earlier ones is the use of a quality score. The use of qualityscoreshasbeenreportedtobea“formofsubjectivitymasqueradingasobjectivity”andithasbeen…

Regional deprivation and non-cancer related computed tomography use in pediatric patients in Germany: Cross-sectional analysis of cohort data.

BACKGROUND: Conflicting findings were observed in recent studies assessing the association between patients' area-level socio-economic status and the received number of computed tomography (CT) examinations in children. The aim was to investigate the association between area-level socio-economic status and variation in CT examination practice for pediatric patients in Germany. METHODS: Data from Radiology Information Systems for children aged 0 to < 15 years without cancer who had at least one CT examination between 2001 and 2010 were extracted in 20 hospitals across Germany. The small-area German Index of Multiple Deprivation (GIMD) was used to assess regional deprivation. The GIMD …

Validation of Semantic Analyses of Unstructured Medical Data for Research Purposes

BACKGROUND: In secondary data there are often unstructured free texts. The aim of this study was to validate a text mining system to extract unstructured medical data for research purposes. METHODS: From a radiological department, 1,000 out of 7,102 CT findings were randomly selected. These were manually divided into defined groups by 2 physicians. For automated tagging and reporting, the text analysis software Averbis Extraction Platform (AEP) was used. Special features of the system are a morphological analysis for the decomposition of compound words as well as the recognition of noun phrases, abbreviations and negated statements. Based on the extracted standardized keywords, findings rep…

Methods for evaluating causality in observational studies.

BACKGROUND: In clinical medical research, causality is demonstrated by randomized controlled trials (RCTs). Often, however, an RCT cannot be conducted for ethical reasons, and sometimes for practical reasons as well. In such cases, knowledge can be derived from an observational study instead. In this article, we present two methods that have not been widely used in medical research to date. METHODS: The methods of assessing causal inferences in observational studies are described on the basis of publications retrieved by a selective literature search. RESULTS: Two relatively new approaches—regression-discontinuity methods and interrupted time series—can be used to demonstrate a causal relat…

Socio-economic status and depression in adolescents

The INTERPHONE study: design, epidemiological methods, and description of the study population

The very rapid worldwide increase in mobile phone use in the last decade has generated considerable interest in the possible health effects of exposure to radio frequency (RF) fields. A multinational case-control study, INTERPHONE, was set-up to investigate whether mobile phone use increases the risk of cancer and, more specifically, whether the RF fields emitted by mobile phones are carcinogenic. The study focused on tumours arising in the tissues most exposed to RF fields from mobile phones: glioma, meningioma, acoustic neurinoma and parotid gland tumours. In addition to a detailed history of mobile phone use, information was collected on a number of known and potential risk factors for t…

Association of mental distress with smoking status in the community: Results from the Gutenberg Health Study.

Abstract Background Exposition to tobacco smoke is among the major modifiable risk factors in the general population. There is strong evidence for a close association between smoking exposure and mental disorders. Methods Cross-sectional associations of different conditions of smoking status (former, current, and second hand smoking (SHS)) with indicators of mental distress were analyzed in a sample of N =5000 participants (aged 35–74 years) of the population-based survey “Gutenberg Health Study”. Results In the general population clinically significant depression (OR 1.59, 95%CI 1.17–2.17) and a previous diagnosis of depression (OR 1.50, 95%CI 1.16–1.94) were associated with current smokin…

Additional file 9 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 9: Web Table 1B. Differentially expressed genes 4 h after exposure to low dose ionizing radiation (0.05 Gray).

Prevalence of refractive errors in the European adult population: the Gutenberg Health Study (GHS).

Objective To study the distribution of refractive errors among adults of European descent. Design Population-based eye study in Germany with15 010 participants aged 35–74 years. Methods The study participants underwent a detailed ophthalmic examination according to a standardised protocol. Refractive error was determined by an automatic refraction device (Humphrey HARK 599) without cycloplegia. Definitions for the analysis were myopia +0.5 D, astigmatism >0.5 cylinder D and anisometropia >1.0 D difference in the spherical equivalent between the eyes. Exclusion criterion was previous cataract or refractive surgery. Results 13 959 subjects were eligible. Refractive errors ranged from −21.5 to…

Occupational Exposure to Extremely Low-Frequency Magnetic Fields and Risk of Amyotrophic Lateral Sclerosis : Results of a Feasibility Study for a Pooled Analysis of Original Data

Bioelectromagnetics 42(4), 271-283 (2021). doi:10.1002/bem.22335

Tumor biology in older breast cancer patients – What is the impact on survival stratified for guideline adherence? A retrospective multi-centre cohort study of 5378 patients

Abstract Purpose The tumor biology of older breast cancer patients (oBCP) is usually less aggressive, however applied adjuvant treatment is often less potent resulting in an impaired disease free survival and overall survival in this group. This study tries to answer the following questions for the biological subtypes of oBCP (70+ y): (1) Is there a significant difference in the distribution of the biological subtypes of oBCP vs younger breast cancer patients (yBCP; 50–69 y)? (2) Which biological subtype has the highest rate of non-guideline-adherent-treatment (GL−) among oBCP? (3) Is a single GL− (i.e. radiotherapy/surgery/endocrine-therapy/chemotherapy) significantly associated with the s…

COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy.

5 Office-based Professional Association Gynecologic Oncologists e.V. in Germany (BNGO e.V.), Berlin; 6 Background: This prospective study evaluated the relationship between arthralgia and compliance during the first year of adjuvant anastrozole therapy in postmenopausal women with hormone receptor-positive early breast cancer. Patients and methods: COMPliance and Arthralgia in Clinical Therapy (COMPACT) was an open-label, multicenter, noninterventional study conducted in Germany. Patients had started adjuvant anastrozole 3-6 months before the study start. The primary end points were arthralgia, compliance, and the relationship between compliance and arthralgia, assessed at specific time poi…

Second follow-up of a German cohort on childhood cancer incidence after exposure to postnatal diagnostic x-ray.

Studies on children exposed to ionizing radiation by computed tomography (CT) indicate an increased risk of leukemia and central nervous system (CNS) tumors. Evidence of the risks associated with diagnostic X-ray examinations, the most frequent examination in pediatric radiology, in which the radiation dose is up to 750 times lower compared to CT examinations, is less clear.a#13; This study presents results of the second follow-up for the risk of childhood cancer in a cohort of children (alt;15 years) with diagnostic X-ray exposure at a large German hospital during 1976-2003 followed for additional 10 years until 2016.a#13; With a latency period of six months, 92,998 children contributed 79…

Is cancer risk of radiation workers larger than expected?

Occupational exposures to ionising radiation mainly occur at low-dose rates and may accumulate effective doses of up to several hundred milligray. The objective of the present study is to evaluate the evidence of cancer risks from such low-dose-rate, moderate-dose (LDRMD) exposures. Our literature search for primary epidemiological studies on cancer incidence and mortality risks from LDRMD exposures included publications from 2002 to 2007, and an update of the UK National Registry for Radiation Workers study. For each (LDRMD) study we calculated the risk for the same types of cancer among the atomic bomb survivors with the same gender proportion and matched quantities for dose, mean age att…

Pediatric Germ Cell Tumors From 1987 to 2011: Incidence Rates, Time Trends, and Survival

BACKGROUND: Malignant germ cell tumors (GCTs) are a rare and a heterogeneous group of pediatric cancers. The incidence rate has increased in some populations or subgroups. However, only a few recent publications on epidemiologic data showing the trends in incidence of pediatric GCTs are available. METHODS: We analyzed the incidence rates, time trends, and survival for 1366 GCTs in children 0 to 14 years old registered in the nationwide, population-based German Childhood Cancer Registry in 1987–2011. RESULTS: The incidence rate of GCTs was slightly higher in girls (age-standardized rate: girls, 5.3; boys, 4.4 per million). A bimodal age distribution was seen. In children aged <1 year…

Assessing Planning Ability Across the Adult Life Span in a Large Population-Representative Sample: Reliability Estimates and Normative Data for the Tower of London (TOL-F) Task

AbstractObjectives:The Tower of London (TOL) test has probably become the most often used task to assess planning ability in clinical and experimental settings. Since its implementation, efforts were made to provide a task version with adequate psychometric properties, but extensive normative data are not publicly available until now. The computerized TOL-Freiburg Version (TOL-F) was developed based on theory-grounded task analyses, and its psychometric adequacy has been repeatedly demonstrated in several studies but often with small and selective samples.Method:In the present study, we now report reliability estimates and normative data for the TOL-F stratified for age, sex, and education …

The Intracranial Distribution of Gliomas in Relation to Exposure From Mobile Phones: Analyses From the INTERPHONE Study

When investigating the association between brain tumors and use of mobile telephones, accurate data on tumor position are essential, due to the highly localized absorption of energy in the human brain from the radio-frequency fields emitted. We used a point process model to investigate this association using information that included tumor localization data from the INTERPHONE Study (Australia, Canada, Denmark, Finland, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Sweden, and the United Kingdom). Our main analysis included 792 regular mobile phone users diagnosed with a glioma between 2000 and 2004. Similar to earlier results, we found a statistically significant association …

46-MENTAL HEALTH IMPACT OF WAR AND VIOLENCE

Childhood Cancer Risk From Conventional Radiographic Examinations for Selected Referral Criteria: Results From a Large Cohort Study

OBJECTIVE: Little is known about the long-term effects of exposure to diagnostic ionizing radiation in childhood. Current estimates are made with models derived mainly from studies of atomic bomb survivors, a population that differs from today's patients in many respects. MATERIALS AND METHODS: We analyzed the cancer incidence among children who underwent diagnostic x-ray exposures between 1976 and 2003 in a large German university hospital. We reconstructed individual radiation doses for each examination and sorted results by groups of referral criteria for all cancers combined, solid tumors, and leukemia and lymphoma combined. RESULTS: A total of 68 incidence cancer cases between 1980…

Depression in the nursing home: a cluster-randomized study to probe the effectiveness of a novel case management approach to improve treatment (the DAVOS project)

Abstract Background Depression is the second most common psychiatric illness in old people. Up to 30% of nursing home residents suffer from minor or major depression. Although depressive disorders in old age can be improved and even cured with adequate therapy, they often go unnoticed in nursing home residents and remain untreated. This highlights a striking deficit in health care and might results not only in lower quality of life among those concerned but also in poor physical functioning, premature mortality and increased hospitalization rates. Methods The aim of the interdisciplinary research project DAVOS is to implement an innovative and stepped structural case management program to i…

Additional file 10 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 10: Web Table 1C. Differentially expressed genes 2 h after exposure to high dose ionizing radiation (2 Gray).

Medical exposure to ionising radiation and the risk of brain tumours: Interphone study group, Germany

Abstract Background The role of exposure to low doses of ionising radiation in the aetiology of brain tumours has yet to be clarified. The objective of this study was to investigate the association between medically or occupationally related exposure to ionising radiation and brain tumours. Methods We used self-reported medical and occupational data collected during the German part of a multinational case–control study on mobile phone use and the risk of brain tumours (Interphone study) for the analyses. Results For any exposure to medical ionising radiation we found odds ratios (ORs) of 0.63 (95% confidence interval (CI) = 0.48–0.83), 1.08 (95% CI = 0.80–1.45) and 0.97 (95% CI = 0.54–1.75)…

Cellular Phones, Cordless Phones, and the Risks of Glioma and Meningioma (Interphone Study Group, Germany)

The widespread use of cellular telephones has generated concern about possible adverse health effects, particularly brain tumors. In this population-based case-control study carried out in three regions of Germany, all incident cases of glioma and meningioma among patients aged 30–69 years were ascertained during 2000–2003. Controls matched on age, gender, and region were randomly drawn from population registries. In total, 366 glioma cases, 381 meningioma cases, and 1,494 controls were interviewed. Overall use of a cellular phone was not associated with brain tumor risk; the respective odds ratios were 0.98 (95% confidence interval (CI): 0.74, 1.29) for glioma and 0.84 (95% CI: 0.62, 1.13)…

Lessons Learned from the German Registry for Acute Aortic Dissection Type A (GERAADA) and Expectations for the Future

The German Registry for Acute Aortic Dissection type A (GERAADA) is a prospective observational clinical multicenter registry that was launched in 2006. With more than 2,500 patients included from over 50 recruiting centers it is—to our knowledge—the most representative register for acute aortic dissection type A (AADA) currently available. We examined mortality and post-operative events as well as the influence of various pre- and intraoperative factors on these endpoints. Among patients registered, 30-day mortality is 15.9 %. 13.4 % of patients experienced postoperatively a new neurological deficit and a total of 10.5 % of patients suffered from permanent neurological impairment 30 days a…

Additional file 8 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 8: Web Table 1A. Differentially expressed genes 2 h after exposure to low dose ionizing radiation (0.05 Gray).

A Cohort Study of Childhood Cancer Incidence after Postnatal Diagnostic X-Ray Exposure

Ionizing radiation is an established cause of cancer, yet little is known about the health effects of doses from diagnostic examinations in children. The risk of childhood cancer was studied in a cohort of 92.957 children who had been examined with diagnostic X rays in a large German hospital during 1976-2003. Radiation doses were reconstructed using the individual dose area product and other exposure parameters, together with conversion coefficients developed specifically for the medical devices and standards used at the radiology department. Newly diagnosed cancers occurring between 1980 and 2006 were determined through record linkage to the German Childhood Cancer Registry. The median ra…

Cardiovascular medication and intraocular pressure: results from the Gutenberg Health Study

BACKGROUND Intraocular pressure (IOP) is well known to be associated with blood pressure and other cardiovascular risk factors. The influence of systemic cardiovascular, in particular antihypertensive, medication on IOP is still controversial. This study analyses the association between the use of cardiovascular medications and IOP in a large European cohort. METHODS The Gutenberg Health Study is a population-based, prospective,observational cohort study in mid-western Germany. IOP was measured using a non-contact tonometer. The medication classes examined were peripheral vasodilators, diuretics, β-blockers (overall, selective and non-selective), calcium channel blockers, renin-angiotensin …

Critical Appraisal of Scientific Articles

Despite the increasing number of scientific publications, many physicians find themselves with less and less time to read what others have written. Selection, reading, and critical appraisal of publications is, however, necessary to stay up to date in one’s field. This is also demanded by the precepts of evidence-based medicine (1, 2). Besides the medical content of a publication, its interpretation and evaluation also require understanding of the statistical methodology. Sadly, not even in science are all terms always used correctly. The word "significance," for example, has been overused because significant (or positive) results are easier to get published (3, 4). The aim of this article …

MENTAL HEALTH AND SUICIDAL IDEATION AMONG 1ST AND 2ND GENERATION MIGRANTS - Results from the Gutenberg Health Study

Mobile phone base stations and adverse health effects: phase 1 of a population-based, cross-sectional study in Germany

Objective: The aim of this first phase of a cross-sectional study from Germany was to investigate whether proximity of residence to mobile phone base stations as well as risk perception is associated with health complaints. Methods: The researchers conducted a population-based, multi-phase, cross-sectional study within the context of a large panel survey regularly carried out by a private research institute in Germany. In the initial phase, reported on in this paper, 30 047 persons from a total of 51 444 who took part in the nationwide survey also answered questions on how mobile phone base stations affected their health. A list of 38 health complaints was used. A multiple linear regression…

Generating survival times to simulate Cox proportional hazards models

Simulation studies present an important statistical tool to investigate the performance, properties and adequacy of statistical models in pre-specified situations. One of the most important statistical models in medical research is the proportional hazards model of Cox. In this paper, techniques to generate survival times for simulation studies regarding Cox proportional hazards models are presented. A general formula describing the relation between the hazard and the corresponding survival time of the Cox model is derived, which is useful in simulation studies. It is shown how the exponential, the Weibull and the Gompertz distribution can be applied to generate appropriate survival times f…

Meta-analysis of gene-environment-wide association scans accounting for education level identifies additional loci for refractive error

Myopia is the most common human eye disorder and it results from complex genetic and environmental causes. The rapidly increasing prevalence of myopia poses a major public health challenge. Here, the CREAM consortium performs a joint meta-analysis to test single-nucleotide polymorphism (SNP) main effects and SNP × education interaction effects on refractive error in 40,036 adults from 25 studies of European ancestry and 10,315 adults from 9 studies of Asian ancestry. In European ancestry individuals, we identify six novel loci (FAM150B-ACP1, LINC00340, FBN1, DIS3L-MAP2K1, ARID2-SNAT1 and SLC14A2) associated with refractive error. In Asian populations, three genome-wide significant loci AREG…

Factors influencing the development of visceral metastasis of breast cancer: A retrospective multi-center study.

Abstract Purpose Visceral metastasis of breast cancer (BC) is an alarming development and correlates with poor median overall survival. The purpose of this retrospective study is to examine the risk factors for developing visceral metastasis by considering tumor biology and patient characteristics. Methods Using the BRENDA database, the risk factors such as histological and intrinsic subtypes of BC, age at primary diagnosis, grading, nodal status, tumor size and year of primary diagnosis were examined in univariate and multivariate analysis. Categorical variables were compared by using χ2 tests. Furthermore, multivariate Cox proportional hazards regression models, Kaplan–Meier product-limit…

Occupational risk factors for low grade and high grade glioma: Results from an international case control study of adult brain tumours

The majority of suspected occupational risk factors for adult brain tumours have yet to be confirmed as etiologically relevant. Within an international case-control study on brain tumours, lifelong occupational histories and information on exposures to specific substances were obtained by direct interviews to further investigate occupational risk factors for glioma. This is one of the largest studies of brain tumours in adults, including 1,178 cases and 1987 population controls from 8 collaborating study centres matched for age, gender and centre. All occupational information, was aggregated into 16 occupational categories. In a pooled analysis, odds ratios (OR), adjusted for education, wer…

Prevalence of Cardiac Disease in Breast Cancer Patients at Time of Diagnosis Compared to the General Female Population in Germany.

<b><i>Background:</i></b> Advances in oncological therapy have significantly improved breast cancer survival; therefore comorbid conditions are becoming more relevant. We investigated the prevalence of prior cardiovascular diseases and risk factors in patients with breast cancer compared to those in the general female population in Germany. <b><i>Methods:</i></b> The PASSOS heart study is a retrospective multicenter cohort study on cardiac late effects in breast cancer patients treated between 1998 and 2008. We analyzed the frequencies of cardiac diseases and cardiovascular risk factors in patients from this cohort as documented in anesthesia …

Genetic variants associated with cardiac structure and function: a meta-analysis and replication of genome-wide association data.

Context Echocardiographic measures of left ventricular (LV) structure and function are heritable phenotypes of cardiovascular disease. Objective To identify common genetic variants associated with cardiac structure and function by conducting a meta-analysis of genome-wide association data in 5 population-based cohort studies (stage 1) with replication (stage 2) in 2 other community-based samples. Design, Setting, and Participants Within each of 5 community-based cohorts comprising the EchoGen consortium (stage 1; n = 12 612 individuals of European ancestry; 55% women, aged 26-95 years; examinations between 1978-2008), we estimated the association between approximately 2.5 million single-nuc…

Air pollution and airport apron workers: A neglected occupational setting in epidemiological research.

Abstract Introduction Airport apron workers are occupationally exposed to jet exhaust and major concern is related to the exposure to ultrafine particles (UFP) from aircrafts. To date, little attention has been given to occupational exposures to aircraft-related UFP, although aircraft engines have high emissions of ultrafine particles, which are orders of magnitude higher than residential exposure. UFP could possibly contribute to the development of cancer, heart disease, mental illness, and respiratory symptoms. In addition to particulate matter, apron workers are exposed to other polluting substances associated with vehicles, aircraft exhaust or direct fuel emissions. Methods We performed…

Association of low birth weight with myopic refractive error and lower visual acuity in adulthood: results from the population-based Gutenberg Health Study (GHS).

PurposeLow birth weight (BW) is linked to impaired organ development in childhood, including altered ocular morphological and functional development. The aim of this study was to evaluate whether low BW has long-term effects on visual acuity and refraction in adulthood.MethodsThe Gutenberg Health Study is a population-based, observational cohort study in Germany, including 15 010 participants aged between 35 and 74 years. These participants were divided into three different BW groups (low: <2500 g; normal: between 2500 and 4000 g; and high: >4000 g). Best-corrected visual acuity and objective refraction were examined. We used multivariable linear regression models with adjustment for …

Study Design in Medical Research

Medical research studies can be split into five phases—planning, performance, documentation, analysis, and publication (1, 2). Aside from financial, organizational, logistical and personnel questions, scientific study design is the most important aspect of study planning. The significance of study design for subsequent quality, the relability of the conclusions, and the ability to publish a study are often underestimated (1). Long before the volunteers are recruited, the study design has set the points for fulfilling the study objectives. In contrast to errors in the statistical evaluation, errors in design cannot be corrected after the study has been completed. This is why the study design…

Assessment of Quality of Life in Postmenopausal Women with Early Breast Cancer Participating in the PACT Trial: The Impact of Additional Patient Information Material Packages and Patient Compliance

<b><i>Background:</i></b> Breast cancer patients’ self-understanding of their disease can impact their quality of life (QoL); the relationship between compliance and QoL is poorly understood. <b><i>Patients and Methods:</i></b> The Patient’s Anastrozole Compliance to Therapy (PACT) program, a prospective, randomized study, investigated the effect of additional patient information material (IM) packages on compliance with adjuvant aromatase inhibitor (AI) therapy in postmenopausal women with hormone receptor-positive early breast cancer. The QoL subanalysis presented here examined the impact of IM packages on QoL and the association between QoL…

0109 Health effects of exposure to arsenic: a 39 years cohort study in manfredonia, italy

Background On September 26th 1976 an accident occurred in a chemical plant located in Manfredonia (Apulia region, Italy) where Caprolactam (plastic) and Urea (fertilisers) were produced. More than 12 tons of arsenic compounds, used in the production of Urea, were released in the atmosphere, contaminating the plant and surrounding areas. Our study investigates late effects of arsenic exposure among workers present on the day of the accident and during the site clearance. Methods We performed a historical cohort study including 1467 workers (39 females). Follow-up was performed by contacting municipalities of residence in Italy. Death certificates were collected. End of follow-up was either d…

The Link Between Local Recurrence and Distant Metastases in Patients With Rectal Cancer.

BACKGROUND/AIM The relationships between local recurrence (LR), the development of distant metastases (DM) and prognosis in patients with rectal cancer remain unclear. PATIENTS AND METHODS In 606 patients who underwent curative resection, the role of LR was assessed retrospectively by time-dependent multivariate Cox models with inverse probability of treatment weighting taking into account competing risks. RESULTS Patients with LR had more DM than patients without LR (49/79, 62% vs. 86/524, 16.4%; p<0.001); 37% of LR-associated DM developed before or at LR, 63% after diagnosis of LR. Fifty-five percent of patients without DM at diagnosis of LR later developed DM. In these patients, the inci…

Occupation and risk of glioma, meningioma and acoustic neuroma: results from a German case-control study (interphone study group, Germany)

Background: Several epidemiological studies have investigated the association between occupation and brain tumour risk, but results have been inconclusive. We investigated the association between six occupational categories defined a priori: chemical, metal, agricultural, construction, electrical/electronic and transport, and the risk of glioma, meningioma and acoustic neuroma. Methods: In a population-based case-control study involving a total of 844 cases and 1688 controls conducted from 2000 to 2003, detailed information on life-long job histories was collected during personal interviews and used to create job calendars for each participant. Job title, job activity, job number, and the s…

Pediatric bone tumors in Germany from 1987 to 2011: incidence rates, time trends and survival

AbstractBackground: Malignant bone tumors are a rare group of childhood cancer.Materials and methods: This study describes incidence rates, survival probabilities, and time trends for 1831 children below 15 years of age with a bone tumor registered at the population-based German Childhood Cancer Registry between 1987 and 2011.Results: Overall age-standardized annual incidence rate (ASR) was 5.5 per million. Osteosarcomas (ASR 2.8) and Ewing tumors (ASR 2.6) were the most frequent diagnostic groups. The incidence of bone tumors overall tended to increase slightly over time by 0.7% each year on average. Thirty-nine of the bone tumor cases reported were subsequent primaries and not included in…

Quality of Life in NSCLC Survivors - A Multicenter Cross-Sectional Study.

The objective was to assess quality of life (QoL) in lung cancer survivors, compare it to the general population, and identify factors associated with global QoL, physical functioning, emotional functioning, fatigue, pain, and dyspnea.Data from NSCLC patients who had survived 1 year or longer after diagnosis were collected cross-sectionally in a multicenter study. QoL was assessed with the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and the lung cancer module QLQ-LC13 across different clinical subgroups and compared to age- and sex-standardized general population reference values. Multivariable linear regression analyses wer…

Aggressive Intrinsic Subtypes in Breast Cancer: A Predictor of Guideline Adherence in Older Patients With Breast Cancer?

Treatment side effects, comorbidities, and guideline-adherent treatment (GL+) influence the oncologic outcome of older breast cancer patients (oBCP) (age ≥ 70 years). The focus of this analysis was to investigate the associations among tumor characteristics, guideline adherence, and outcome and to compare these associations between younger breast cancer patients (yBCP) (age 50-69 years) and oBCP.This is a retrospective multicenter cohort study with 17 participating certified breast cancer centers. The analysis of 10,897 patient records collected from 1992 to 2008 for GL+ and clinical outcome was performed. Tumor and patient characteristics and their associations with GL+ were compared betwe…

AB1394 Compliance and arthralgias in clinical therapy (compact): Assessment of the incidence of arthralgia, therapy costs and compliance within the first year of anastrozole therapy

Background Aromatase inhibitors (AI) are well established as adjuvant endocrine treatment for postmenopausal women with hormone receptor-positive (HR+) early breast cancer (EBC). Drug-induced myalgia or arthralgia is among the most frequently reported adverse drug reactions to AIs. Objectives Little is known about the pathomechanism by which AIs cause muscle and joint injury. The literature on skeletal muscle complaints with AIs is confusing, in part because of a lack of clear definitions. Myalgia/arthralgia is defined as muscle/joint pain and is likely to affect patients’ quality of life and compliance with AI medication . We designed a prospective trial to collect real world data on the e…

The Impact of Pre-Operative Malperfusion on Outcome in Acute Type A Aortic Dissection

Abstract Background Malperfusion adversely affects outcomes in patients with acute type A aortic dissection, but reliable quantitative data are lacking. Objectives The aim of this study was to analyze the impact of various forms of malperfusion on early outcome. Methods A total of 2,137 consecutive patients enrolled in GERAADA (German Registry for Acute Aortic Dissection Type A) who underwent surgery between 2006 and 2010, of whom 717 (33.6%) had any kind of pre-operative malperfusion, were retrospectively analyzed. Results All-cause 30-day mortality was 16.9% and varied substantially according to the number of organ systems affected by malperfusion (none, 12.6%; 1 system, 21.3%; 2 systems,…

Invitation to cervical cancer screening does increase participation in Germany: Results from the MARZY study

The effect of different invitation models on participation in cervical cancer screening (CCS) was investigated in a randomized population-based cohort study in Germany. Participants were randomly selected via population registries and randomized into intervention Arm A (invitation letter) and Arm B (invitation letter and information brochure) or control Arm C (no invitation). The intervention and control arms were compared with regard to 3-year participation and the two invitation models were compared between intervention arms. Of the 7,758 eligible women aged 30-65 years, living in the city of Mainz and in the rural region of Mainz-Bingen, 5,265 were included in the analysis. Differences i…

Sociodemographic factors associated with time to discharge for hospitalised patients with asthma and asthma exacerbation using the Ghana Health Service District Information Management System 2 (DHIMS-2) database, 2012–2017

ObjectiveData on asthma hospitalisations are a useful source of patient morbidity information. In Ghana, the length of stay (LoS) and sociodemographic factors of patients hospitalised for asthma and its exacerbation are understudied. We aimed to investigate the time to discharge and assessed factors associated with length of hospital stays of asthmatics in Ghana.MethodsRetrospective analysis of hospitalised patient with asthma records between 2012 and 2017 from the nationwide Ghana Health Service District Health Information Management System 2 database. We calculated the cumulative incidence function for discharge stratified by age group and sex. Multivariable Cox regression was used to inv…

Epidemiological studies of cancer in aircrew.

Exposure to cosmic ionising radiation, in addition to other specific occupational risks, is of concern to aircrew members. Epidemiological studies provide an objective way to assess the health of this occupational group. We systematically reviewed the epidemiological literature on health of aircrew members since 1990, focusing on cancer as the endpoint of interest. Sixty-five relevant publications were identified and reviewed. Whereas overall cancer incidence and mortality was generally lower than in the comparison population, consistently elevated risks were reported for breast cancer incidence in female aircrew members and for melanoma in both male and female aircrew members. Brain cancer…

Abstract 13257: FEV1 and FVC predict Mortality in Individuals Without Manifest Lung Disease Independent of Cardiac Performance - Results From the Population-based Gutenberg Health Study

Background: Pulmonary disease has consistently been related to increased mortality. We investigated central spirometry variables in relation to total mortality in individuals from the general population without diagnosed lung disease also accounting for cardiac function. Methods: In 15,010 individuals from the general population (mean age 55±11 years, age range 35-74 years, 50.5% men) in the Gutenberg Health Study we performed spirometry and multimodal transthoracic echocardiography. The biomarkers N-terminal pro-B-type natriuretic peptide (Nt-proBNP) and high-sensitive troponin I (TnI) were measured in the first 5000 individuals using commercially available assays. Multivariable Cox regre…

Assessing the impact of CMF/FEC/FEC-DOC/ETC (dose-dense) adjuvant chemotherapy in dependency of positive axillary lymph nodes on survival: A retrospective multicenter cohort study of 4,526 breast cancer patients receiving adjuvant chemotherapy.

1074 Background: Adjuvant chemotherapy has changed dramatically in the last decades. Anthracycline-/taxane-based and dose-dense chemotherapy regimens improved survival in node positive breast cancer. This study tries to answer the following questions: (1) Are there differences in survival dependent on chemotherapy regimens in 0/0-3/4-10/&lt;10 positive lymph nodes? (2) Is it possible to define a cut-off of positive lymph nodes for the use of Taxane-based and dose dense chemotherapy? Methods: This German is a multi-center [17 participating hospitals all are certified as breast cancer centers] retrospective cohort study. We included CMF (1.385), FEC (1.170), FEC-DOC (1.723), and dose-dense E…

Data Analysis of Epidemiological Studies

Epidemiology is used to describe the distribution of diseases in the population and to analyze the causes of these diseases. One important objective is to identify risk factors and to quantify their significance. A risk factor can influence the probability that a specific disease develops. Risk factors include: Environmental influences (for example, exposure to radon) Predisposition (for example, genes), or Behavioral characteristics (for example, hormone intake). Epidemiological research employs various different types of study (1–3), depending on the question asked. The most important are Cohort studies Case-control studies, and Cross-sectional studies In cohort studies, persons exposed t…

Second Malignancies Following Childhood Cancer Treatment in Germany From 1980 to 2014.

BACKGROUND Because of improvements in cancer treatment, more than 80% of all children with cancer now survive at least five years from the time of diagnosis. As a result, late sequelae of cancer and its treatment have become more common, particularly second malignancies. We studied the current incidence of second malignancies among childhood cancer survivors in Germany. METHODS This study is based on the cohort of the German Childhood Cancer Registry (Deutsches Kinderkrebsregister, DKKR). Persons given the diagnosis of a first malignancy at any time in the years 1980-2014 who were no more than 14 years old at the time of diagnosis and survived at least six months thereafter were included in…

Does chemotherapy improve survival in patients with nodal positive luminal A breast cancer? A retrospective Multicenter Study.

BackgroundIn this study based on the BRENDA data, we investigated the impact of endocrine ± chemotherapy for luminal A, nodal positive breast cancer on recurrence free (RFS) and overall survival (OS). In addition, we analysed if tumor size of luminal A breast cancer influences survival in patients with the same number of positive lymph nodes.MethodsIn this retrospective multi-centre cohort study data of 1376 nodal-positive patients with primary diagnosis of luminal A breast cancer during 2001-2008 were analysed. The results were stratified by therapy and adjusted by age, tumor size and number of affected lymph nodes.ResultsIn our study population, patients had a good to excellent prognosis …

Additional file 2 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 2: Web Figure 7. Shared pathways from low and high dose ionizing radiation experiments. Gy = Gray. Web Figure 8. Pathways only affected in high dose ionizing radiation experiments. Gy = Gray.

Biologically based models of cancer risk in radiation research

PURPOSE: In radiation risk analysis the state-of-the-art approach is based on descriptive models which link excess rates of cancer incidence and mortality to radiation exposure by statistical association. To estimate the number of sporadic and radiation-induced cases descriptive models apply parametric dose response function which directly determine the radiation risk. In biologically-based models of cancer risk (BBCR models) dose responses are implemented for key events on the biological level such as early mutations or clonal expansion of initiated cells. Influenced by radiation these events then shape the risk response on the epidemiological level. Although BBCR models facilitate a more …

Screening for breast and cervical cancer in a large German city: participation, motivation and knowledge of risk factors.

Few data exist on attendance for cervical and breast cancer screening, breast self-examination and knowledge about risk factors for cervical cancer among German women. A population-based survey was performed in the city of Bielefeld in Germany.A questionnaire was mailed to 1500 randomly selected women age 25 to 75. Of those, 540 questionnaires were returned and 532 were analysed.Women participating in the survey considered themselves well informed about possibilities for early detection of breast cancer (84.0%). Most information was received from office-based gynaecologists (82.4%). 82.8% had a breast examination by a medical doctor annually and 43.1% practised breast self-examination every…

Planning and Analysis of Trials Using a Stepped Wedge Design: Part 26 of a Series on Evaluation of Scientific Publications

Background The stepped-wedge design (SWD) of clinical trials has become very popular in recent years, particularly in health services research. Typically, study participants are randomly allotted in clusters to the different treatment options. Methods The basic principles of the stepped wedge design and related statistical techniques are described here on the basis of pertinent publications retrieved by a selective search in PubMed and in the CIS statistical literature database. Results In a typical SWD trial, the intervention is begun at a time point that varies from cluster to cluster. Until this time point is reached, all participants in the cluster belong to the control arm of the trial…

Association between chronic dental infection and acute myocardial infarction.

Introduction: In patients with cardiovascular diseases several risk factors such as high blood pressure, diabetes, smoking and drinking habits, genetic disposition, and chronic inflammation must be considered. The aim of this study was to investigate whether there is a correlation between dental origin infections and the presence of an acutemyocardialinfarction(AMI).Methods:Atotalof125 patients who had experienced a myocardial infarction and 125healthyindividualswereincludedinthisstudy.Theoral examination was carried out following the consent of the ethics committee and the National Board for Radiation Protection and included the number of teeth, endodontically treated teeth, periodontal sc…

Standard treatment of female patients with breast cancer decreases substantially for women aged 70 years and older: a German clinical cohort study

Standard treatment of patients with breast cancer decreases with age and older persons are mostly excluded from clinical trials. We hypothesized that non-adherence to treatment guidelines occurs for women agedor =70 years and changes overall survival (OAS) and disease-free survival (DFS).We enrolled 1922 women agedor =50 years with histologically confirmed invasive breast cancer treated at the University of Ulm from 1992 to 2005. Adherence to guidelines and effects on OAS and DFS for women agedor =70 years was compared with that for younger women (50-69 years).Women70 years less often received recommended breast-conserving therapy (70-79 years: 74%-83%;79 years: 54%) than women agedor =69 y…

Screening

Background The early detection of cancer and other diseases is generally considered beneficial, yet there is evidence that in some diseases screening may be of limited benefit. To clarify this issue, we present the statistical principles that underlie screening. Methods We define screening and discuss the conditions for its successful use. We give illustrative examples from among the currently recommended types of screening in Germany and from the recent medical literature, particularly with regard to mammography.

EPI-CT: design, challenges and epidemiological methods of an international study on cancer risk after paediatric and young adult CT

Computed tomography (CT) has great clinical utility and its usage has increased dramatically over the years. Concerns have been raised, however, about health impacts of ionising radiation exposure from CTs, particularly in children, who have a higher risk for some radiation induced diseases. Direct estimation of the health impact of these exposures is needed, but the conduct of epidemiological studies of paediatric CT populations poses a number of challenges which, if not addressed, could invalidate the results. The aim of the present paper is to review the main challenges of a study on the health impact of paediatric CTs and how the protocol of the European collaborative study EPI-CT, coor…

Aspirin use and breast cancer risk: a meta-analysis and meta-regression of observational studies from 2001 to 2005

Purpose To examine the recent epidemiological studies on aspirin use and breast cancer risk published from 2001 to 2005 within a meta-analysis, to investigate reasons for heterogeneity between the individual studies and to analyse a dose-response-relationship considering frequency and duration of use. Methods We systematically searched for cohort-studies and case-control-studies from 2001–2005, which evaluated the association between aspirin and breast cancer risk. We calculated a pooled estimate for the relative risk (RR) and investigated reasons for heterogeneity between the individual studies and analysed a dose-response-relationship using random effects mixed models. Results We identifi…

Depression in the nursing home: a cluster-randomized stepped-wedge study to probe the effectiveness of a novel case management approach to improve treatment (the DAVOS project)

Abstract Background Depression is the second most common psychiatric illness in old people. Up to 30% of nursing home residents suffer from minor or major depression. Although depressive disorders in old age can be improved and even cured with adequate therapy, they often go unnoticed in nursing home residents and remain untreated. This highlights a striking deficit in health care and might results not only in lower quality of life among those concerned but also in poor physical functioning, premature mortality and increased hospitalization rates. Methods The aim of the interdisciplinary research project DAVOS is to implement an innovative and stepped structural case management program to i…

Additional file 3 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 3: Web Figure 9. Predicted downsteam diseases and functions. Web Figure 10. Predicted upstream regulators. LDIR = Low dose of ionizing radiation (0.05 Gray), HDIR = High dose of ionizing radiation (2 Gray).

Iatrogenic acute aortic dissection type A: insight from the German Registry for Acute Aortic Dissection Type A (GERAADA)†

OBJECTIVES: Previous investigators have reported a grave prognosis for iatrogenic acute aortic dissection (iAADA), but such studies are limited by their small sample sizes. The purpose of the current study was to analyse the clinical characteristics, current management and surgical outcomes in a large number of iAADA patients identified through a multicentre registry. METHODS: Between July 2006 and June 2010, 50 centres participated in the German Registry for Acute Aortic Dissection Type A (GERAADA). Of the 2137 patients included, 100 (5%) had iAADA. We compared the clinical features and 30-day outcomes of patients with iatrogenic and spontaneous acute aortic dissection type A (sAADA). RESU…

Depression, Anxiety and Quality of Life in Long-Term Survivors of Malignant Melanoma: A Register-Based Cohort Study

Aim The purpose of the study was to determine anxiety and depression, quality of life, and their determinants in long-term survivors of malignant melanoma. Methods In a state cancer registry a cohort of survivors of malignant melanoma was contacted via the physician registered. Of 1302 contactable patients, 689 (52.2%) completed a questionnaire including the Patient Health Questionnaire with generalized anxiety (GAD-7) and depression (PHQ-9) and the EORTC Quality of Life Questionnaire (EORTC QLQ 30). Based on multiple regression analysis, predictors of quality of life and distress were identified. Comparison data were assessed in two waves of representative face-to-face household surveys of…

Shift Work and Prostate Cancer Incidence in Industrial Workers

In 2007 the International Agency for Research on Cancer (IARC) classified shift work involving circadian disruption as a probable human carcinogen (1). Most of the evidence for this is based on animal experiment models and only a few reliable epidemiological studies. The cancer best described to date is breast cancer; this has mainly been investigated in female nurses and flight attendants (2, 3). Shift work can also increase the incidence of prostate cancer, as plausibly described in a review article published in 2012 (4). Mechanistically, it is possible that nocturnal light exposure and disrupted circadian rhythms cause cancer, or that tumor growth is favored by hormonal mediation. Noctur…

Diagnostic radiological examinations and risk of intracranial tumours in adults—findings from the Interphone Study

Abstract Background Exposure to high doses of ionizing radiation is among the few well-established brain tumour risk factors. We used data from the Interphone study to evaluate the effects of exposure to low-dose radiation from diagnostic radiological examinations on glioma, meningioma and acoustic neuroma risk. Methods Brain tumour cases (2644 gliomas, 2236 meningiomas, 1083 neuromas) diagnosed in 2000–02 were identified through hospitals in 13 countries, and 6068 controls (population-based controls in most centres) were included in the analysis. Participation across all centres was 64% for glioma cases, 78% for meningioma cases, 82% for acoustic neuroma cases and 53% for controls. Informa…

Prevalence of cardiovascular late sequelae in long-term survivors of childhood cancer: A systematic review and meta-analysis

Background Cardiovascular diseases are well-known late effects of childhood cancer and research on these late effects is a highly important emerging field. We conducted a systematic review with a meta-analysis to give an overview of the current evidence and the prevalence of late cardiovascular events. Procedure We included publications in which the study populations were children and adolescents who survived cancer. Outcome was defined as all cardiovascular clinical and subclinical endpoints or diagnoses appearing at least one year after cancer diagnosis. A systematic overview is presented for all included studies. A quantitative meta-analysis was conducted for hypertension and stroke. Res…

Outcome after surgery for acute aortic dissection type A in patients over 70 years: data analysis from the German Registry for Acute Aortic Dissection Type A (GERAADA)☆

Objective: The number of elderly patients undergoing emergency surgery for acute aortic dissection type A (AADA) is rising. Published results report a higher risk for thesepatients comparedwith younger patients. The aim of our study wasto analyse the surgicaloutcomeof these patients and to identify those at risk. Methods: Between July 2006 and June 2009, 44 centres participating in the German Registry for Acute Aortic Dissection Type A (GERAADA) reported a total of 1558 patients. As many as 381 patients were between 70 and 80 years of age (septuagenarians), while 83 patients were 80 years and older (octogenarians). We compared the clinical features and events occurring 30 days after surgery…

Noise annoyance is associated with depression and anxiety in the general population : the contribution of aircraft noise

BACKGROUND: While noise annoyance has become recognized as an important environmental stressor, its association to mental health has hardly been studied. We therefore determined the association of noise annoyance to anxiety and depression and explored the contribution of diverse environmental sources to overall noise annoyance. PATIENTS AND METHODS: We investigated cross-sectional data of n = 15.010 participants of the Gutenberg Health Study (GHS), a population-based, prospective, single-center cohort study in Mid-Germany (age 35 to 74 years). Noise annoyance was assessed separately for road traffic, aircraft, railways, industrial, neighborhood indoor and outdoor noise ("during the day"; "i…

Subclinical impairment of lung function is related to mild cardiac dysfunction and manifest heart failure in the general population.

Lung function impairment has previously been related to heart failure, although no overt cardiovascular or structural heart disease is present. The extent to which pulmonary function is related to subclinical left ventricular impairment in the general population remains to be investigated.15010 individuals from the general population (mean age 55±11years, 50.5% men) in the Gutenberg Health Study underwent spirometry, transthoracic echocardiography and biomarker measurement. Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) in percent of the predicted value and FEV1/FVC ratio were associated with echocardiographic measures of cardiac structure, systolic and diastolic func…

Cohort study of occupational cosmic radiation dose and cancer mortality in German aircrew, 1960-2014.

ObjectivesTo determine cancer mortality compared with the general population and to examine dose-response relationships between cumulative occupational radiation dose and specific cancer outcomes in the German aircrew cohort.MethodsFor a cohort of 26 846 aircrew personnel, standardised mortality ratios (SMR) were calculated. Dose-response analyses were carried out using Poisson regression to assess dose-related cancer risks for the period 1960–2014. Exposure assessment comprises recently available dose register data for all cohort members and newly estimated retrospective cabin crew doses for 1960–2003.ResultsSMR for all-cause, specific cancer groups and most individual cancers were reduced…

Childhood Leukemia in the Vicinity of Nuclear Power Plants in Germany

SUMMARY The causes of leukemia are largely unclear. The question whether leukemia rates are increased near nuclear power plants is controversial. The German Childhood Cancer Registry has published an epidemiological case-control study on childhood cancer and nuclear power plants. Method: The study was based on the distance of children's residences from nuclear power plants and addressed the question whether children under age 5 with cancer live closer, on average, to nuclear power plants than randomly selected controls. Odds Ratios (OR) for distance categories and standardized incidence ratios (SIR) were calculated. Results: An association was found between the nearness of residence to nucl…

Cohort Profile: the EPI-CT study: a European pooled epidemiological study to quantify the risk of radiation-induced cancer from paediatric CT

International audience; •The multinational EPI-CT study was set-up in 2011 to provide direct estimates of risk of solid tumours and leukaemia among children and young adults who underwent computed tomography (CT) scanning and to consolidate the scientific basis for optimization of paediatric CT protocols and patient protection.•Under a common protocol, cohort studies were conducted in Belgium, Denmark, France, Germany, the Netherlands, Norway, Spain, Sweden and the United Kingdom, coordinated by the International Agency for Research on Cancer (IARC). •The study recruited a total of about 950,000 patients having undergone at least one CT-scan before the age of 22 years. A total of 8.7 millio…

Participation in adjuvant clinical breast cancer trials: Is there a difference in survival compared to guideline adherent adjuvant treatment? A retrospective multicenter cohort study of 5,326 patients.

1082 Background: Clinical trials (CT) usually compare a standard treatment regime versus innovative new substances or regimens. However participation in CT is available for only few patients and exclusion criteria is usually very strict. Therefore this study tries to answer the following questions: (1) Does participation in adjuvant CT improve survival in breast cancer (BC)? (2) Is there a difference in survival compared to guideline adherence and what is the role of the other treatments surrounding adjuvant breast cancer treatment? Methods: This German multi-center [17 participating hospitals all are certified as breast cancer centers] retrospective cohort study called BRENDA (BRENDA = qu…

Severe and uncontrolled adult asthma is associated with vitamin D insufficiency and deficiency

Background Vitamin D has effects on the innate and adaptive immune system. In asthmatic children low vitamin D levels are associated with poor asthma control, reduced lung function, increased medication intake, and exacerbations. Little is known about vitamin D in adult asthma patients or its association with asthma severity and control. Methods Clinical parameters of asthma control and 25-hydroxyvitamin D (25(OH)D) serum concentrations were evaluated in 280 adult asthma patients (mean ± SD: 45.0 ± 13.8 yrs., 40% male, FEV1 74.9 ± 23.4%, 55% severe, 51% uncontrolled). Results 25(OH)D concentrations in adult asthmatics were low (25.6 ±11.8 ng/ml) and vitamin D insufficiency or deficiency (vi…

Trends in hospitalization of patients with diabetes mellitus in Ghana from 2012 to 2017 with predictions to 2032

Abstract Background This study explores sociodemographic and health factors associated with hospitalizing diabetes mellitus (DM) patients and estimates the number of future hospitalizations for DM in Ghana. Methods We conducted a secondary analysis using nationally representative patient hospitalization data provided by the Ghana Health Service and projected population counts from the Ghana Statistical Service. Data were stratified by year, age, sex and region. We employed Poisson regression to determine associations between sociodemographic and health factors and hospitalization rates of DM patients. Using projected population counts, the number of DM-related hospitalizations for 2018 thro…

Participation in adjuvant clinical breast cancer trials: does study participation improve survival compared to guideline adherent adjuvant treatment? A retrospective multi-centre cohort study of 9,433 patients.

Abstract Adjuvant clinical trials (CTs) usually compare a standard treatment regime versus an innovative new substance or regimen. Participation in CT however, is available for only few patients and exclusion criteria are usually very strict. Therefore we used an unselected patient cohort to investigate the following questions: (1) Is participation in adjuvant CT associated with improved survival in breast cancer (BC)? (2) What is the impact of guideline conform therapy on survival in BC compared to that of participants in CT? Does guideline-conform adjuvant treatment provide an equal impact? Material and methods This German retrospective multi-centre cohort study included 9433 patients wit…

0329 Occupational exposure to metals and welding fumes, and risk of glioma in the interocc study

Background Brain tumouraetiology is poorly understood. Based on their ability to pass through the blood-brain barrier, it has been hypothesised that exposure to metals may increase the risk of brain cancer. Results from the few epidemiological studies on this issue are inconsistent. Methods We investigated the relationship between glioma risk and occupational exposure to five metals - lead, cadmium, nickel, chromium and iron- as well as to welding fumes, using data from the seven-country INTEROCC study. A total of 1800 incident glioma cases and 5160 controls aged 30–69 years were included in the analysis. Lifetime occupational exposure to the agents was assessed using the INTEROCC JEM, a mo…

Epidemiological investigations of aircrew: an occupational group with low-level cosmic radiation exposure.

Aircrew and passengers are exposed to low-level cosmic ionising radiation. Annual effective doses for flight crew have been estimated to be in the order of 2-5 mSv and can attain 75 mSv at career end. Epidemiological studies in this occupational group have been conducted over the last 15-20 years, usually with a focus on radiation-associated cancer. These studies are summarised in this note. Overall cancer risk was not elevated in most studies and subpopulations analysed, while malignant melanoma, other skin cancers and breast cancer in female aircrew have shown elevated incidence, with lesser risk elevations in terms of mortality. In some studies, including the large German cohort, brain c…

Additional file 1 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 1: Web Figure 1. Representative measurements of the cell cycle distribution of HOECHST33258-stained fibroblasts by flow cytometry during (A) log-phase growth or (B) after G0/1 synchronization over 14 days for radiation experiments. Web Figure 2. Total number of differentially expressed genes in human fibroblasts from cancer free-controls at 0.25 h, 2 h and 24 h after exposure to low (0.05 Gray (Gy)) or high dose (2Gy) of X-rays compared to unirradiated fibroblasts (N = 3). Web Figure 3. Correlation of RNA quality metrics (RIN, Qbit RNA-concentration), expression variation (PC1–3) and number of aligned reads (aligned reads, aligned reads normalized) for all experiments. The c…

The 15-Country Collaborative Study of Cancer Risk among Radiation Workers in the Nuclear Industry: Estimates of Radiation-Related Cancer Risks

International audience; A 15-Country collaborative cohort study was conducted to provide direct estimates of cancer risk following protracted low doses of ionizing radiation. Analyses included 407,391 nuclear industry workers monitored individually for external radiation and 5.2 million person-years of follow-up. A significant association was seen between radiation dose and all-cause mortality [excess relative risk (ERR) 0.42 per Sv, 90% CI 0.07, 0.79; 18,993 deaths]. This was mainly attributable to a dose-related increase in all cancer mortality (ERR/Sv 0.97, 90% CI 0.28, 1.77; 5233 deaths). Among 31 specific types of malignancies studied, a significant association was found for lung cance…

Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Abstract Background Exposure to ionizing radiation induces complex stress responses in cells, which can lead to adverse health effects such as cancer. Although a variety of studies investigated gene expression and affected pathways in human fibroblasts after exposure to ionizing radiation, the understanding of underlying mechanisms and biological effects is still incomplete due to different experimental settings and small sample sizes. Therefore, this study aims to identify the time point with the highest number of differentially expressed genes and corresponding pathways in primary human fibroblasts after irradiation at two preselected time points. Methods Fibroblasts from skin biopsies of…

Location of Gliomas in Relation to Mobile Telephone Use: A Case-Case and Case-Specular Analysis

The energy absorbed from the radio-frequency fields of mobile telephones depends strongly on distance from the source. The authors' objective in this study was to evaluate whether gliomas occur preferentially in the areas of the brain having the highest radio-frequency exposure. The authors used 2 approaches: In a case-case analysis, tumor locations were compared with varying exposure levels; in a case-specular analysis, a hypothetical reference location was assigned for each glioma, and the distances from the actual and specular locations to the handset were compared. The study included 888 gliomas from 7 European countries (2000-2004), with tumor midpoints defined on a 3-dimensional grid …

Inzidenz von Kinderkrebs nach Röntgendiagnostik im Patientenkollektiv der Jahre 1976 – 2003 einer Universitäts-Kinderklinik

Purpose: Although the carcinogenic effect of ionizing radiation is well known, knowledge gaps persist on the health effects of low-dose radiation, especially in children. The cancer incidence rate in a cohort of 92,957 children diagnosed using X-rays in the years 1976-2003 in the radiology department of a large university clinic was studied. Materials and Methods: Individual radiation doses per examination were reconstructed using an algorithm taking into account the dose area product and other exposure parameters together with conversion factors computed specifically for the equipment and protocols used in the radiology department. Incident cancer cases in the period 1980-2006 were identif…

Kontaktuntersuchungen bei aktiver Tuberkulose und Management latenter Tuberkulose: 5 Jahres-Analyse an einem deutschen Großstadt Gesundheitsamt

Zusammenfassung Hintergrund Im Rahmen der Tuberkulosekontrolle führen Gesundheitsämter auf Grundlage des Infektionsschutzgesetzes (IfSG) in Deutschland Untersuchungen bei Kontaktpersonen von Tuberkulosepatienten durch, um eine mögliche Infektion bei diesen Personen zu identifizieren. Ziel dieser Untersuchung war es, die Maßnahmen des Kölner Gesundheitsamtes bei neu diagnostizierten Fällen von latenter Tuberkulose Infektion (LTBI) über einen Zeitraum von 5 Jahren retrospektiv zu analysieren. Material und Methoden Daten des Kölner Gesundheitsamts von Untersuchungen bei Kontaktpersonen von Tuberkuloseerkrankten im Zeitraum 01.07.2012 bis 31.12.2016 wurden analysiert. Fehlende Zeichen einer akt…

Retrospektive Bestimmung der elektromagnetischen Exposition durch analoge Rundfunksender im Rahmen von KiSS

Im Rahmen einer epidemiologischen Fall-Kontroll-Studie zur Untersuchung eines möglichen Zusammenhangs zwischen der Häufigkeit kindlicher Leukämien und elektromagnetischer Strahlung (,,KiSS&quot; &amp;ndash; &lt;b&gt;Ki&lt;/b&gt;ndliche Leukämien und Expositionen in der Umgebung von hochfrequenten &lt;b&gt;S&lt;/b&gt;ende&lt;b&gt;s&lt;/b&gt;tationen) soll die Exposition durch leistungsstarke analoge Rundfunksender retrospektiv (Zeitraum 1982&amp;ndash;2003) quantifiziert werden. Die zu betrachtenden Sendernetze für AM-Hörfunk, FM-Hörfunk und analoges Fernsehen unterscheiden sich nicht nur hinsichtlich der Modulationsart und der von den Einzelsendern abgestrahlten Leistung, sondern auch in de…

Burden of cardiovascular risk factors and cardiovascular disease in childhood cancer survivors: Data from the German CVSS-study.

Aims: The cardiac and vascular late sequelae in long-term survivors of childhood cancer (CVSS)-study aimed to quantify the prevalence of cardiovascular risk factors (CVRF) and cardiovascular disease (CVD) in German childhood cancer survivors (CCS). Methods and results: In the CVSS-study (NCT02181049), 1002 CCS (age range 23-48 years) diagnosed with neoplasia prior to 15 years of age between 1980 and 1990 prospectively underwent a systematic, standardized clinical and laboratory cardiovascular screening, identical to the population-based Gutenberg Health Study (GHS) cohort. For 951 individuals, prevalences of CVRF and CVD were primarily compared to the GHS sample and to two further German po…

The Prevalence of Glaucoma in Young People.

BACKGROUND Earlier information on the prevalence of glaucoma among children in Germany was based solely on estimates. Reported values for congenital glaucoma range from 1 in 10 000 to 1 in 68 000 depending on ethnic origin. The estimate for juvenile glaucoma is 1 in 44 000. METHODS The Gutenberg Health Study is a populationbased, prospective, monocentric cohort study with 15 010 participants aged 35 to 74. To determine the history-based prevalence of childhood glaucoma, participants were asked about the diagnosis of glaucoma, any operations for glaucoma that were performed, regular use of drugs for glaucoma, and the age of onset of glaucoma. The affected individuals were classified in four …

Reply to ‘Comment on: Baaken D, Hammer GP, Seidenbusch MC, Schneider K, Spix C, Blettner M, Pokora R and Lorenz E 2019 Second follow-up of a German cohort on childhood cancer after exposure to postnatal diagnostic x-ray J. Radiol. Prot. 39 1074–91’

Kosmische Strahlung und Gesundheit bei Flugreisen

No evidence for an association of plasma homocysteine levels and refractive error – Results from the population-based Gutenberg Health Study (GHS)

Purpose There is a strong association between severe hyperhomocysteinemia and myopia. Thus we studied the hypothesis that even moderately increased levels of homocysteine (Hcy) might be a potentially treatable risk factor for myopia. Methods The Gutenberg Health Study (GHS) is a population-based, prospective, observational cohort study in Germany, including 15,010 participants aged between 35 and 74 at recruitment. The baseline examination was conducted from 2007–2012. Refraction was measured using autorefraction (HARK 599, Carl Zeiss AG, Jena, Germany). Hcy was measured by an immunoassay. We included only phakic participants without a history of corneal surgery or corneal laser treatment. …

The course of psychiatric co-morbidity in patients with breast cancer - results from the prospective multi-centre BRENDA II study

Purpose This study examined the frequency of psychiatric co-morbidity in patients with breast cancer, its changes over time and predictors for these changes. Methods In a prospective study with measurements before surgery (t1, baseline), 1 month (t2) and 8 months thereafter (t3) using the Patient Health Questionnaire, we examined the course of psychiatric co-morbidity in breast cancer patients. The co-morbidity courses were grouped into healthy (no co-morbidity during the study), acute (co-morbidity at t1 and/or t2, but not at t3), emerging (no co-morbidity at t1, but at t3) and chronic (co-morbidity at t1 and t3). Results Of the 598 participants, 19% had acute, 10% emerging and 9% chronic …

Calculating confidence intervals for impact numbers

Abstract Background Standard effect measures such as risk difference and attributable risk are frequently used in epidemiological studies and public health research to describe the effect of exposures. Recently, so-called impact numbers have been proposed, which express the population impact of exposures in form of specific person or case numbers. To describe estimation uncertainty, it is necessary to calculate confidence intervals for these new effect measures. In this paper, we present methods to calculate confidence intervals for the new impact numbers in the situation of cohort studies. Methods Beside the exposure impact number (EIN), which is equivalent to the well-known number needed …

Kindliche Leukämien und EMF-Expositionen in der Umgebung hochfrequenter Sendestationen (KiSS) &ndash; Fragestellung und Studienbeschreibung

Abstract. Im Rahmen einer Fall-Kontroll-Studie wird untersucht, ob es einen Zusammenhang zwischen dem Leukämierisiko bei Kindern und der Exposition gegenüber elektromagnetischen Feldern in der Umgebung leistungsstarker Sendestationen von Rundfunk und Fernsehen gibt. Bislang wurden fünf Studien im Umkreis von Rundfunksendeanlagen durchgeführt. Deren Aussagekraft ist jedoch durch eine grobe Expositionsabschätzung und ihren ökologischen Studienansatz ohne individuelle Expositionsbestimmung limitiert. Wesentliches Element der hier vorgestellten Studie ist dagegen eine individuelle Expositionsabschätzung, die zum einen auf der Geocodierung von Wohnadressen und Expositionspunktquellen und zum and…

Cluster-Randomized Studies.

Background Cluster-randomized trials (CRT) are needed to compare interventions that are allocated to entire groups of subjects, rather than to individuals. Publications about CRT have become steadily more common over the past decade. Readers of such publications should be able to categorize and interpret the findings of CRT correctly while considering the methodological requirements applicable to this type of study. Methods This review is based on a selection of pertinent literature and on the authors' expertise. CRT-specific methodological aspects of the planning, performance, and interpretation of studies are discussed. Results Readers of publications on CRT should check whether due consi…

Correlation between fecal incontinence and quality of life after low anterior resection for rectal cancer

SUMMARY Aim: The purpose of this study was to investigate the correlation between fecal incontinence and quality of life after low anterior resection and long-term follow-up. Methods: For 72 patients with coloanal or low colorectal anastomosis, the quality of life was determined by the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires C-30 and CR-38. The Vaizey score was used for assessment of fecal incontinence. Results: The risk of fecal incontinence significantly increased with a lower level of anastomosis (p &lt; 0.001). The QLQ CR-38 did not discern differences between patients. The OLQ C-30 only found significantly worse social and role function in pat…

Mortality in patients with acute aortic dissection type A: analysis of pre- and intraoperative risk factors from the German Registry for Acute Aortic Dissection Type A (GERAADA)

Acute aortic dissection type A (AADA) is an emergency with excessive mortality if surgery is delayed. Knowledge about independent predictors of mortality on surgically treated AADA patients is scarce. Therefore, this study was conducted to identify pre- and intraoperative risk factors for death.Between July 2006 and June 2010, 2137 surgically treated patients with AADA were enrolled in a multicentre, prospective German Registry for Acute Aortic Dissection type A (GERAADA), presenting perioperative status, operative strategies, postoperative outcomes and AADA-related risk factors for death. Multiple logistic regression analysis was performed to identify the influence of different parameters …

Intraoperative neuroprotective drugs without beneficial effects? Results of the German Registry for Acute Aortic Dissection Type A (GERAADA).

OBJECTIVES: Cerebral protection during acute aortic dissection Type A (AADA) surgery may be affected by perfusion strategies and ischaemic protective drugs. METHODS: We analysed the impact of intraoperative barbiturate, steroid and mannitol use and adjunctive cerebral perfusion (CP), on 30-day mortality and new postoperative mortality-corrected permanent neurological dysfunction (PNDmc) in the German Registry for Acute Aortic Dissection Type A. RESULTS: Two thousand one hundred and thirty-seven AADA patients were registered over a 4-year period. The overall 30-day mortality was 16.9%, and the overall rate of PNDmc was 10.0%. A total of 48% of patients received no neuroprotective drugs (cont…

Establishing Equivalence or Non-Inferiority in Clinical Trials

Background: An increasing number of clinical trials are being performed to show the absence of relevant differences between the effects of two treatments. The primary care physician makes use of the results of so-called equivalence studies, at least indirectly, practically every day. Equally important are active control clinical trials in which the efficacy of a new treatment has to be proven through demonstrating non-inferiority as compared to a standard treatment. Methods: Explanation of basic principles and statistical techniques with reference to the original literature; selective searches in the medical literature. Results: First of all, a suitable distributional parameter must be chos…

Big Data in Medical Science–a Biostatistical View

Big data” is a universal buzzword in business and science, referring to the retrieval and handling of ever-growing amounts of information. It can be assumed, for example, that a typical hospital generates hundreds of terabytes (1 TB = 1012 bytes) of data annually in the course of patient care (1). For instance, exome sequencing, which results in 5 gigabytes (1 GB = 109 bytes) of data per patient, is on the way to becoming routine (2). The analysis of such enormous volumes of information, i.e., organization and description of the data and the drawing of (scientifically valid) conclusions, can already hardly be accomplished with the traditional tools of computer science and statistics. For ex…

The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer.

BACKGROUND Compliance and persistence are often overlooked in adjuvant breast cancer treatment. PATIENTS AND METHODS PACT was a prospective, multicenter, randomized, open, parallel-group study assessing whether educational materials (EMs) enhanced compliance with aromatase inhibitor (AI) therapy in postmenopausal women with early, hormone-receptor-positive (HR+) breast cancer. The primary end points were compliance (proportion taking ≥ 80% anastrozole) at 12 months and persistence (proportion reporting anastrozole intake during the study period). RESULTS Four thousand eight hundred and forty-four patients were randomly assigned 1:1 to receive standard therapy or standard therapy with EMs. T…

The merits and limits of pooling data from nuclear power worker studies

Meta-Analysis in Epidemiology

The use of meta-analyses in order to synthesise the evidence from epidemiological studies has become more and more popular recently. It has been estimated by Egger et al. (1998) that from articles retrieved by MEDLINE with the medical subject heading (MeSH) term “meta-analysis” some 33% reported results of a meta-analysis from randomised clinical trials and nearly the same proportion (27%) were from observational studies, including 12% papers in which the aetiology of a disease was investigated. The remaining papers include methodological publications or review articles. Reasons for the popularity of meta-analyses are the growing information in the scientific literature and the need of time…

Sero-epidemiological analysis of the risk of virus infections for childhood leukaemia.

Virus infections have been thought to be involved in the development of childhood leukaemia. In order to address this issue we determined, in a case-control study, the prevalence of antibodies to viruses infecting blood or bone-marrow cells [Epstein-Barr virsus (EBV), human herpes virus type 6 (HHV-6), parvovirus B19] as well as to the human virus known for its tumour-suppressive properties, the adeno-associated virus type 2 (AAV-2), in the sera of 121 children with leukaemia in Germany, and in 197 control individuals, hospitalized for other reasons, and matched for age and gender to the cases. In addition, we developed a questionnaire to be answered by the children's parents, in order to g…

Knowledge about infection with human papillomavirus: a systematic review.

Abstract Objective. Human papillomavirus (HPV) is a necessary cause of cervical cancer and genital warts. The aim of this systematic literature review was to provide an overview of knowledge about HPV infection among the public, students, patients and health professionals. Method. PubMed searches were performed and the results of studies were reported by age, gender, study population, country, recruitment score and year of study conduct. The recruitment score covered the mode of recruitment, study size and response rate. Results. We included 39 studies published between 1992 and 2006 covering a total of 19,986 participants. The proportion of participants who had heard of HPV varied from 13%…

Cervical Cancer Screening: Comparison of Conventional Pap Smear Test, Liquid-Based Cytology, and Human Papillomavirus Testing as Stand-alone or Cotesting Strategies

Abstract Background: Some countries have implemented stand-alone human papillomavirus (HPV) testing while others consider cotesting for cervical cancer screening. We compared both strategies within a population-based study. Methods: The MARZY cohort study was conducted in Germany. Randomly selected women from population registries aged ≥30 years (n = 5,275) were invited to screening with Pap smear, liquid-based cytology (LBC, ThinPrep), and HPV testing (Hybrid Capture2, HC2). Screen-positive participants [ASC-US+ or high-risk HC2 (hrHC2)] and a random 5% sample of screen-negatives were referred to colposcopy. Post hoc HPV genotyping was conducted by GP5+/6+ PCR-EIA with reverse line blottin…

Sun exposure and malignant lymphoma: A population-based case–control study in Germany

Although some causes for malignant lymphoma are known their etiology is not well understood so far. We analyze the relationship between sun exposure and malignant lymphoma in a multicenter, population-based case-control study. Patients with malignant lymphoma (n = 710, 18-80 years) were prospectively recruited in 6 study regions in Germany. For each case, a gender, region and age-matched control was drawn from population-registers. In personal interviews, lifetime holidays spent in sunny climate, outdoor leisure activities and sunbed or sunlamp use were recorded. On basis of job task-specific supplementary questionnaires, an occupational physician assessed the cumulative working time outsid…

Compliance and arthralgias in clinical therapy (COMPACT): Assessment of the incidence of arthralgia, therapy costs, and compliance in the first year of adjuvant anastrozole.

e11040^ Background: Aromatase Inhibitors (AI) are well established as adjuvant endocrine treatment for postmenopausal women with HR+ early breast cancer (EBC). However, clinical trial data show higher frequently of arthralgia with AI than tamoxifen. As arthralgia may be greatly influencing compliance to adjuvant therapy, we designed a prospective trial to collect real world data on the effects of AI-associated arthralgia on patient compliance, patient outcomes and treatment costs of arthralgia. Methods: COMPACT is an open, prospective non-interventional study (NCT00857012) assessing the incidence of arthralgia, therapy costs, and compliance within the first year of adjuvant anastrozole (AN…

TP53 codon 72 polymorphism and cervical cancer

Background Cervical cancer is caused primarily by human papillomaviruses (HPV). The polymorphism rs1042522 at codon 72 of the TP53 tumour-suppressor gene has been investigated as a genetic cofactor. More than 80 studies were done between 1998 and 2006, after it was initially reported that women who are homozygous for the arginine allele had a risk for cervical cancer seven times higher than women who were heterozygous for the allele. However, results have been inconsistent. Here we analyse pooled data from 49 studies to determine whether there is an association between TP53 codon 72 polymorphism and cervical cancer.Methods Individual data on 7946 cases and 7888 controls from 49 different st…

Epidemiological Measures in the Context of the COVID-19 Pandemic.

BACKGROUND: The various epidemiological indicators used to communicate the impact of COVID-19 have different strengths and limitations. METHODS: We conducted a selective literature review to identify the indicators used and to derive appropriate definitions. We calculated crude and age-adjusted indicators for selected countries. RESULTS: The proportion of deaths (case fatality proportion [CFP]; number of deaths/total number of cases) is commonly used to estimate the severity of a disease. If the CFP is used for purposes of comparison, the existence of heterogeneity in the detection and registration of cases and deaths has to be taken into account. In the early phase of an epidemic, when cas…

Evaluation of the methodological quality of articles on autologous breast reconstruction

Abstract Background Breast cancer remains the most common cancer among women worldwide. Autologous breast reconstruction may contribute toward restoring body image and improving quality of life after mastectomy. This systematic literature review describes differences in the quality and type of studies investigating autologous breast reconstruction techniques over time. Methods MEDLINE was searched for articles related to the surgical techniques, namely, TRAM, LADO, DIEP, and SGAP/IGAP, for the periods 1970 to 2007 and 2008 to 2010. The quality and type of studies were compared across the two time periods. Full-texts were evaluated according to prespecified quality criteria. Results The MEDL…

Distribution and categorization of left ventricular measurements in the general population: results from the population-based Gutenberg Heart Study.

Background— Echocardiography, the dominant imaging modality for quantification of left ventricular metrics, has undergone continuing development in the past few decades. However, given the lack of population-based data, current guidelines are still based on restricted and small data sets analyzed with methods including expert opinion. This work presents empirically derived reference values from a large-scale, epidemiologic study conducted with state-of-the-art imaging technology and methods. Methods and Results— The distribution of echocardiographic measurements of the left ventricle was analyzed in a population-based sample of 5000 mid-Europeans from the Gutenberg Heart Study in Germany. …

The 15-Country Collaborative Study of Cancer Risk Among Radiation Workers in the Nuclear Industry: design, epidemiological methods and descriptive results.

International audience; Radiation protection standards are based mainly on risk estimates from studies of atomic bomb survivors in Japan. The validity of extrapolations from the relatively high-dose acute exposures in this population to the low-dose, protracted or fractionated environmental and occupational exposures of primary public health concern has long been the subject of controversy. A collaborative retrospective cohort study was conducted to provide direct estimates of cancer risk after low-dose protracted exposures. The study included nearly 600,000 workers employed in 154 facilities in 15 countries. This paper describes the design, methods and results of descriptive analyses of th…

Is guideline-adherent adjuvant treatment an equivalent option for elderly patients who cannot participate in adjuvant clinical breast cancer trials? A retrospective multicenter cohort study of 4,142 patients.

1063 Background: It is well accepted that innovation in oncology is transported through randomized clinical trials (CT). However, elderly patients (>65) are usually excluded from CT. Therefore this...

Smoking differently modifies suicide risk of affective disorders, substance use disorders, and social factors

Abstract Background Although an association between smoking and suicide has repeatedly been shown, information about a modifying influence of smoking on other risk factors for suicide is lacking. Methods Axis I and Axis II disorders, sociodemographic factors, and tobacco use were assessed by a semi-structured interview including the Structured Clinical Interview for DSM-IV Axis I (SCID-I) and Personality Disorders (SCID-II) in 163 suicides (mean age 49.6 +/− 19.3 years; 64.4% men;) by psychological autopsy method and by personal interview in 396 living population-based control persons (mean age 51.6 +/− 17.0 years; 55.8% men). Results Smoking status (current smokers, lifetime non-smokers, a…

The Prevalence of Visual Impairment in the Adult Population

Background The distribution of visual impairment is an indicator of the health status of the population and for the frequency of diseases of the eye. Methods The Gutenberg Health Study (GHS) is a population-based cohort study in Germany concerning adults aged 35 to 74. 15 010 subjects from the Mainz-Bingen region underwent general medical and ophthalmological examination, with measurement of the distance-corrected visual acuity in each eye separately. As per the World Health Organization criteria, visual impairment was defined as an acuity below 0.3 in the better eye, and blindness as an acuity below 0.05. All patients who were found to be visually impaired or blind underwent further indivi…

Integration of a radiation biomarker into modeling of thyroid carcinogenesis and post-Chernobyl risk assessment

Strong evidence for the statistical association between radiation exposure and disease has been produced for thyroid cancer by epidemiological studies after the Chernobyl accident. However, limitations of the epidemiological approach in order to explore health risks especially at low doses of radiation appear obvious. Statistical fluctuations due to small case numbers dominate the uncertainty of risk estimates. Molecular radiation markers have been searched extensively to separate radiation-induced cancer cases from sporadic cases. The overexpression of the CLIP2 gene is the most promising of these markers. It was found in the majority of papillary thyroid cancers (PTCs) from young patients…

Atrial Fibrillation Manifestations Risk Factors and Sex Differences in a Population-Based Cohort (From the Gutenberg Health Study)

Sex differences in cardiovascular risk factors, cardiac structure and function, and disease and symptom burden in the common arrhythmia atrial fibrillation (AF) have not been investigated systematically at the population level. Cross-sectional data of 14,796 subjects (age range 35 to 74 years, 50.5% men) from the population-based Gutenberg Health Study were examined to show the distribution of cardiovascular risk factors by AF status and sex, and to determine sex-specific predictors for AF. The prevalence of AF was higher in men (4.3%) than in women (1.9%). Men had a worse cardiovascular risk factor profile, a higher prevalence of cardiovascular disease, but fewer symptoms than women. Age-a…

Association of Type D personality with cognitive functioning in individuals with and without cardiovascular disease: The Gutenberg health study

ObjectiveDistressed (‘Type D’) personality is associated with adverse health outcomes in patients with cardiovascular disease (CVD). While personality traits from the Five-Factor Model are related to cognitive functioning, neither Type D personality nor its underlying traits negative affectivity (NA) and social inhibition (SI) have been investigated regarding cognition. We therefore compared the predictive value of Type D classification and its subcomponents NA and SI on planning performance in individuals with and without CVD.MethodsType D personality traits (DS14) were determined in a population-based sample of 4026 participants (including 549 with CVD) aged 40–80 years from the Gutenberg…

Comorbidity-dependent adherence to guidelines and survival in breast cancer-Is there a role for guideline adherence in comorbid breast cancer patients? A retrospective cohort study with 2137 patients.

In the treatment of breast cancer, decisions on adjuvant treatment reflect individual patient characteristics like age and comorbidity. This study assessed the association between adherence to guidelines for adjuvant treatment and survival while taking into account age at diagnosis and comorbidities. We collected the Charlson comorbidity index at baseline for 2179 women treated for primary breast cancer from 1992 to 2008 who participated in a German retrospective multicenter cohort study. We assessed subsequent adjuvant therapy guideline adherence and survival in relation to baseline comorbidities. Guidelines for adjuvant chemotherapy and radiotherapy were more often violated in patients wi…

Role of C-reactive protein in atherogenesis: can the apolipoprotein E knockout mouse provide the answer?

Objective—Human C-reactive protein (CRP) was reported to accelerate atherosclerotic lesion development in male but not in female apolipoprotein E (apoE) knockout mice. Here, mice expressing rabbit CRP (rbCRP) were crossbred onto apoE knockout animals, and the effect on atherogenesis was studied.Methods and Results—Hemolytic complement activity could not be detected in apoE knockout mice. Furthermore, in contrast to human complement, neither rabbit nor human CRP complexed to modified low-density lipoprotein–activated murine complement. At 52 weeks, rbCRP levels were similar in male and female transgenic animals. Serum cholesterol levels were equivalent in female animals irrespective of rbCRP…

Armbrust et al. 2015: Randomization questionable

It is certainly possible that Cesarean delivery modifications like the one described by Armbrust, Hinkson, von Wiezsacker, and Henrich [1] are well received by mothers and partners, but some seriou...

Testicular cancer risk associated with occupational radiation exposure: a systematic literature review.

Testicular cancer is a rare disease, affecting mainly young men aged 15-49. There have been some recent reports that it might be associated with radiation exposure. We have systematically reviewed this topic. English-language articles published between 1990 and 2008 studying the relationship between occupational radiation exposure and testicular cancer were included. Risk of bias was assessed using a modified version of the EPHPP checklist. For ionising radiation we subdivided study populations into occupational groups. No pooled analysis was performed due to the heterogeneity of studies. Seven case-control and 30 cohort studies were included in the review. For radiation workers, one incide…

Is extracapsular nodal extension in sentinel nodes a predictor for nonsentinel metastasis and is there an impact on survival parameters?-A retrospective single center cohort study with 324 patients

The Z0011 trial has fundamentally changed axillary management in breast cancer patients. However, some important questions remain, like the role of extracapsular nodal extension (ENE) in positive sentinel nodes and the need for further axillary treatment. In this retrospective cohort study, we reviewed and analyzed data from 342 clinically node negative (cN0) breast cancer patients with a positive sentinel node and subsequent axillary lymph node dissection (ALND) from the BRENDA data base. The 104 (30.4%) ENE positive patients had a significantly higher proportion of ≥3 positive axillary lymph nodes (65.0%) compared to ENE negative patients with a positive sentinel node (21.4%). Likewise, E…

976Screening for cervical cancer with Human Papillomavirus testing: stand-alone is preferable over co-testing with cytology

Abstract Background Cervical cancer screening can be conducted with cytology and Human Papillomavirus (HPV) testing but few studies have compared the latter directly to concomitant testing (co-testing). We compared these strategies to determine appropriate screening. Methods Within a randomised population-based cohort study conducted around Mainz, Germany, eligible women (≥30 years) were screened via Pap smear, liquid-based cytology (LBC) and HPV testing (HC2) and HPV genotyped post hoc (PCR). These tests formed three strategies: cytology (Pap or LBC) and HPV (HC2 or PCR) stand-alone and co-testing. Screen positives and 5% negative women were invited to colposcopy. Absolute and relative sen…

Which patient- and physician-related factors influence guideline adherence in adjuvant endocrine therapy?: Results of the prospective multi-center cohort study BRENDA II.

e11544 Background: This study examined the question, which factors influence patients’ and physicians’ decisions associated with guideline adherent adjuvant endocrine therapy (ET). Methods: In a pr...

Incidence of childhood cancer of the head and neck in Germany.

Background: Only very limited data are available in the literature on the incidence of childhood cancer of the head and neck worldwide. Methods: Based on data obtained from the national German Childhood Cancer Registry, a total of 370 malignancies of the head and neck in children under the age of 15 (199 boys and 171 girls), which were reported to this institution between 1994 and 2003, were analysed in this study. Results: The overall incidence of malignancies of specific sites of the head and neck in Germany is 4.48 per 100000 children. The most frequently observed entities, representing primary tumours, are soft tissue sarcomas (0.39/100000), lymphomas (0.09/100000) and thyroid carcinoma…

Vascular Leakage in Severe Dengue Virus Infections: A Potential Role for the Nonstructural Viral Protein NS1 and Complement

Background Vascular leakage and shock are the major causes of death in patients with dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS). Thirty years ago, complement activation was proposed to be a key underlying event, but the cause of complement activation has remained unknown. Methods The major nonstructural dengue virus (DV) protein NS1 was tested for its capacity to activate human complement in its membrane-associated and soluble forms. Plasma samples from 163 patients with DV infection and from 19 patients with other febrile illnesses were prospectively analyzed for viral load and for levels of NS1 and complement-activation products. Blood and pleural fluids from 9 patient…

Confidence Interval or P-Value?: Part 4 of a Series on Evaluation of Scientific Publications

An understanding of p-values and confidence intervals is necessary for the evaluation of scientific articles. This article will inform the reader of the meaning and interpretation of these two statistical concepts.The uses of these two statistical concepts and the differences between them are discussed on the basis of a selective literature search concerning the methods employed in scientific articles.P-values in scientific studies are used to determine whether a null hypothesis formulated before the performance of the study is to be accepted or rejected. In exploratory studies, p-values enable the recognition of any statistically noteworthy findings. Confidence intervals provide informatio…

Dose-dependent expression of CLIP2 in post-Chernobyl papillary thyroid carcinomas

Summary This study showed a clear dose-response relationship for the CLIP2 radiation marker in post-Chernobyl papillary thyroid carcinoma cohorts for young patients and hints to different molecular mechanisms in tumors induced at low doses compared to moderate/high doses.

Quality control for exposure assessment in epidemiological studies

In the framework of an epidemiological study, dosemeters were used for the assessment of radio frequency electromagnetic field exposure. To check the correct dosemeter's performance in terms of consistency of recorded field values over the entire study period, a quality control strategy was developed. In this paper, the concept of quality control and its results is described. From the 20 dosemeters used, 19 were very stable and reproducible, with deviations of a maximum of +/- 1 dB compared with their initial state. One device was found to be faulty and its measurement data had to be excluded from the analysis. As a result of continuous quality control procedures, the confidence in the meas…

Association between cognitive impairment and guideline adherence for application of chemotherapy in older patients with breast cancer: Results from the prospective multicenter BRENDA II study

Background This study examined the association between cognitive impairment and guideline adherence for application of chemotherapy in older patients with breast cancer. Patients and methods In the prospective multicenter cohort study BRENDA II, patients aged ≥65 years with primary breast cancer were sampled over a period of 4 years (2009-2012). A multiprofessional team (tumor board) discussed recommendation for adjuvant chemotherapy according to the German S3 guideline. Cognitive impairment was screened by the clock-drawing test (CDT) prior to adjuvant treatment. Results Two hundred and sixty-three patients were included in the study and CDT data were available for 193 patients. Thirty-one…

Estimated radiation exposure of German commercial airline cabin crew in the years 1960-2003 modeled using dose registry data for 2004-2015.

Exposure to ionizing radiation of cosmic origin is an occupational risk factor in commercial aircrew. In a historic cohort of 26,774 German aircrew, radiation exposure was previously estimated only for cockpit crew using a job-exposure matrix (JEM). Here, a new method for retrospectively estimating cabin crew dose is developed. The German Federal Radiation Registry (SSR) documents individual monthly effective doses for all aircrew. SSR-provided doses on 12,941 aircrew from 2004 to 2015 were used to model cabin crew dose as a function of age, sex, job category, solar activity, and male pilots' dose; the mean annual effective dose was 2.25 mSv (range 0.01–6.39 mSv). In addition to an inverse …

Influence of operative strategy for the aortic arch in DeBakey type I aortic dissection: Analysis of the German Registry for Acute Aortic Dissection Type A

Objective Patients treated with an extensive approach including total aortic arch replacement for acute aortic dissection type A may have a favorable long-term prognosis by treating the residual false lumen. Our goal was to analyze the operative strategy for treatment of type I DeBakey aortic dissection from the German Registry for Acute Aortic Dissection Type A (GERAADA) data. Methods A total of 658 patients with type I DeBakey aortic dissection and entry only in the ascending aorta were identified in the GERAADA. Patients in group A underwent replacement of the ascending aorta with hemiarch replacement. Patients in group B received extensive treatment with total arch replacement or conven…

Association between socioeconomic factors and sleep quality in an urban population-based sample in Germany.

BACKGROUND: Good sleep quality is essential for recovery. The risk factors of sleep disorders have been extensively investigated, but there is sparse information on the association of socioeconomic factors with a person's sleep quality. The aim of the present analysis is to investigate this association, taking particularly the effect of health confounders into consideration.METHODS: The data were extracted from the cross-sectional QUEBEB Study. In total, the study sample consisted of 3281 participants (1817 women and 1464 men, aged 16-72 years). Here socioeconomic status (SES) was collected from the baseline survey taken in 2004. Sleep quality for the same participants was measured with in-…

Breast Cancer Patients' Fear of Treatment: Results from the Multicenter Longitudinal Study BRENDA II.

Background: Fear of cancer treatment can become overwhelming. It is important to understand what patients are mainly afraid of and what factors are correlated with intense fear of treatment. Methods: Patients with primary breast cancer (n = 761) completed questionnaires about fear of treatment before surgery (t1), and before (t2) and after (t3) adjuvant treatment. Psychological co-morbidity was assessed using the Patient Health Questionnaire. Logistic regression identified predictors of intense fear of treatment. Results: Patients were most afraid of chemotherapy (mean score 3.5), and fear remained high throughout follow-up; fear of radiotherapy and of surgery was lower and decreased over t…

The association between extremely low-frequency electromagnetic fields and childhood leukaemia in epidemiology: enough is enough?

Background: Previous pooled analyses have reported an association between magnetic fields and childhood leukaemia. We present a pooled analysis based on primary data from studies on residential magnetic fields and childhood leukaemia published after 2000. Methods: Seven studies with a total of 10 865 cases and 12 853 controls were included. The main analysis focused on 24-h magnetic field measurements or calculated fields in residences. Results: In the combined results, risk increased with increase in exposure, but the estimates were imprecise. The odds ratios for exposure categories of 0.1–0.2 μT, 0.2–0.3 μT and ⩾0.3 μT, compared with <0.1 μT, were 1.07 (95% CI 0.81–1.41), 1.16 (0.69–1.93)…

Testicular cancer and viral infections: A systematic literature review and meta-analysis

In 1984, Newell and coworkers were the first to suggest that testicular cancer might have a viral etiology since it showed similar characteristics to Hodgkin's lymphoma. A systematic literature review and meta-analysis was conducted to investigate a possible association between viral infections (EBV, CMV, Parvovirus B19, HPV, and HIV) and testicular cancer. Articles published from 1985 through June 2010 were located from MEDLINE and EMBASE databases, 21 articles were finally included in the review. For infection with EBV, CMV, Parvovirus B19, and HIV the pooled OR were 4.80 (95% CI 0.98–23.54), 1.85 (95% CI 0.92–3.70), 2.86 (95% CI 0.35–23.17), and 1.79 (95% CI 1.45–2.21) respectively. No p…

Additional file 5 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 5: Web Figure 12. Comparison of predicted downstream diseases and functions in different data sets.

Time trends, sociodemographic and health factors associated with discharge and length of stay of hospitalised patients with sickle cell disease in Ghana: a retrospective analysis of national routine health database

ObjectivePatients with sickle cell disease (SCD) are prone to multiple episodes resulting in frequent hospital visits. We determined the time trends, sociodemographic and health factors associated with length of stay (LoS) for patients with SCD in Ghana.Design, participants, settingWe retrospectively analysed SCD hospitalisation records of 22 680 patients from a nationwide database of the Ghana Health Service from 2012 to 2017.Outcome measuresFactors associated with LoS were estimated using Cox regression, while the cumulative incidence of being discharged alive was estimated with in-hospital death as a competing risk.ResultsPatients admitted for SCD over 6 years constituted 22 680 (0.8%) o…

Additional file 6 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 6: Web Figure 13. Comparison of predicted upstream regulators in different data sets.

Substance use disorders as risk factors for suicide in an Eastern and a Central European city (Tallinn and Frankfurt/Main)

Cultural and regional differences on the well-known elevated suicide risk in substance use disorders have not been clarified yet. Therefore, the suicide risk associated with substance use disorders in a society of transition and in a socially and economically stable society should be identified and compared. Data from two population-based matched case-control studies were used to analyse the association between alcohol and other substance consumption and the risk of suicide. Data in Frankfurt were obtained by a semi-structured interview including the Structured Clinical Interview for DSM-IV Axis I (SCID-I) in 163 suicides that occurred in 1999 and 2000, and data from Tallinn were collected …

Überlegungen des Expertenbeirats zu Anträgen im Rahmen des Innovationsfonds

Zusammenfassung Der Innovationsfonds schafft Anreize zur Entwicklung und Erprobung von Versorgungsinnovationen im Bereich der gesetzlichen Krankenversicherung (GKV) mit dem Ziel einer qualitativen Weiterentwicklung der Versorgung in Deutschland. Uber einen Zeitraum von zunachst vier Jahren (2016-19) werden jahrlich 300 Millionen Euro fur Projekte zu „Neuen Versorgungsformen“ und zur „Versorgungsforschung“ bereitgestellt. Der vom Bundesministerium fur Gesundheit (BMG) berufene zehn-kopfige Expertenbeirat begutachtet in einem formalisierten Verfahren alle Antrage anhand verschiedener Kriterien auf wissenschaftliche Gute, Innovationsgehalt, Versorgungsrelevanz und Implementierbarkeit. Das vorl…

P5361The diabetic continuum and its relation with cardiovascular disease: results from the population-based Gutenberg health study

Abstract 1832: Associations between ovarian cancer and other malignant neoplasms in an international population-based study

Abstract Recent studies have suggested that different histological types of ovarian cancer develop via different pathways. Large epidemiological studies of first and second malignant neoplasms associated with ovarian cancer can quantify such risk and may provide etiologic clues in understanding these complex pathways. We analyzed ovarian cancer data from 13 different cancer registries in Europe, Australia, Canada and Singapore from 1943-2000. Cumulative risks were calculated using a competing risk model, and standardized incidence ratios (SIR) for 34 cancers were estimated based on the observed numbers of second malignancies and the expected numbers obtained from population-specific inciden…

Randomized Controlled Trials

Background In clinical research, randomized controlled trials (RCTs) are the best way to study the safety and efficacy of new treatments. RCTs are used to answer patient-related questions and are required by governmental regulatory bodies as the basis for approval decisions.

Mobile Phones and Health Risks

Epidemiological studies which have been conducted up to date have found little evidence linking short-term mobile phone use to an increased risk of brain tumors. Some studies have shown slight increases in risk for long-term mobile phone users (>10 years). These results are however based on small numbers and need confirmation. Keywords: mobile phones; health risks; brain tumors; epidemiological studies

FEV1 and FVC predict all-cause mortality independent of cardiac function - Results from the population-based Gutenberg Health Study.

Abstract Background Lung function has previously been related to increased mortality. Whether pulmonary impairment is associated with an increased mortality independent of cardiac dysfunction remains unclear. Methods In 15010 individuals from the general population (age range 35–74years, 51% men) in the Gutenberg Health Study we performed spirometry and transthoracic echocardiography. N-terminal pro-B-type natriuretic peptide (Nt-proBNP) and high-sensitive troponin I (hsTnI) were measured in all individuals. 1819 individuals with pulmonary diseases were excluded from further analysis. Results The median for forced expiratory volume in 1s (FEV1) was 94.2% and for forced vital capacity (FVC) …

Concordance Analysis

Background In this article, we describe qualitative and quantitative methods for assessing the degree of agreement (concordance) between two measuring or rating techniques. An assessment of concordance is particularly important when a new measuring technique is introduced.

Methodological considerations for interrupted time series analysis in radiation epidemiology: an overview

Interrupted time series analysis (ITSA) is a method that can be applied to evaluate health outcomes in populations exposed to ionizing radiation following major radiological events. Using aggregated time series data, ITSA evaluates whether the time trend of a health indicator shows a change associated with the radiological event. That is, ITSA checks whether there is a statistically significant discrepancy between the projection of a pre-event trend and the data empirically observed after the event. Conducting ITSA requires one to consider specific methodological issues due to unique threats to internal validity that make ITSA prone to bias. We here discuss the strengths and limitations of …

Acute Aortic Dissection Type A : Age-related Management and Outcomes Reported in the German Registry for Acute Aortic Dissection Type A (GERAADA) of Over 2000 Patients

To determine the association between age and clinical presentation, management and surgical outcomes in a large contemporary, prospective cohort of patients with acute aortic dissection type A (AADA).AADA is one of the most life-threatening cardiovascular diseases, and delayed surgery or overly conservative management can result in sudden death.The perioperative and intraoperative conditions of 2137 patients prospectively reported to the multicenter German Registry for Acute Aortic Dissection Type A were analyzed.Of all patients with AADA, 640 (30%) were 70 years or older and 160 patients (7%) were younger than 40 years. The probability of aortic dissection extension to the supra-aortic ves…

Annoyance to different noise sources is associated with atrial fibrillation in the Gutenberg Health Study

Abstract Background Annoyance is a common reaction in populations exposed to environmental noise and is associated with cardiovascular diseases. We investigated for the first time the existence of an association between noise annoyance and atrial fibrillation (AF). Methods and results Cross-sectional data from 14,639 participants of the Gutenberg Health Study were collected between 2007 and 2012. Annoyance from road traffic, aircraft, railways, industrial/construction and neighbourhood noise during daytime and sleep were collected from all participants through questionnaires using a 5-point scale. AF was assessed via self-reported medical history and/or documentation of AF on the study elec…

The distribution of whole blood viscosity, its determinants and relationship with arterial blood pressure in the community: cross-sectional analysis from the Gutenberg Health Study.

Background: Blood viscosity has a role in modulating cardiovascular homeostasis; changes in this parameter have been associated with cardiovascular mortality and morbidity. However, it remains unclear whether these changes are (1) involved in the pathophysiology of disease, (2) an epiphenomenon, or (3) the expression of counterregulatory mechanisms. We report data on the normal values of blood viscosity and its association with cardiovascular risk factors, prevalent cardiovascular disease, and blood pressure in a large population-based cohort study. Methods and results: Viscosity was calculated using validated formulae and its associations were explored in 15,010 participants (mean 55.0, mi…

Radiofrequency electromagnetic fields emitted from base stations of DECT cordless phones and the risk of glioma and meningioma (Interphone Study Group, Germany)

The objective of this study was to test the hypothesis that exposure to continuous low-level radiofrequency electromagnetic fields (RF EMFs) increases the risk of glioma and meningioma. Participants in a population-based case-control study in Germany on the risk of brain tumors in relation to cellular phone use were 747 incident brain tumor cases between the ages of 30 and 69 years and 1494 matched controls. The exposure measure of this analysis was the location of a base station of a DECT (Digital Enhanced Cordless Telecommunications) cordless phone close to the bed, which was used as a proxy for continuous low-level exposure to RF EMFs during the night. Estimated odds ratios were 0.82 (95…

Influence of GSM signals on human peripheral lymphocytes: study of genotoxicity.

Exposure to radiofrequency (RF) electromagnetic fields (EMF) is continuously increasing worldwide. Yet, conflicting results of a possible genotoxic effect of RF EMF continue to be discussed. In the present study, a possible genotoxic effect of RF EMF (GSM, 1,800 MHz) in human lymphocytes was investigated by a collaboration of six independent institutes (institutes a, b, c, d, e, h). Peripheral blood of 20 healthy, nonsmoking volunteers of two age groups (10 volunteers 16-20 years old and 10 volunteers 50-65 years old) was taken, stimulated and intermittently exposed to three specific absorption rates (SARs) of RF EMF (0.2 W/kg, 2 W/kg, 10 W/kg) and sham for 28 h (institute a). The exposures…

Assessment of radiofrequency exposure from cellular telephone daily use in an epidemiological study: German Validation study of the international case-control study of cancers of the brain--INTERPHONE-Study.

The objective of the study is to validate self-reported cellular phone use information by comparing it with the cumulative emitted power and duration of calls measured by software-modified cellular phones (SMP). The information was obtained using a questionnaire developed for the international case-control study on the risk of the use of mobile phones in tumours of the brain or salivary gland (INTERPHONE-study).The study was conducted in Bielefeld, Germany. Volunteers were asked to use SMPs instead of their own cellular phones for a period of 1 month. The SMP recorded the power emitted by the mobile phone handset during each base station contact. Information on cellular phone use for the sa…

Ionising radiation and lens opacities in interventional physicians: results of a German pilot study

We assessed the feasibility of an epidemiological study on the risk of radiation-related lens opacities among interventional physicians in Germany. In a regional multi-centre pilot study associated with a European project, we tested the recruitment strategy, a European questionnaire on work history for the latter dosimetry calculation and the endpoint assessment. 263 interventional physicians and 129 non-exposed colleagues were invited. Questionnaires assessed eligibility criteria, risk factors for cataract, and work history relating to occupational exposure to ionising radiation, including details on type and amount of procedures performed, radiation sources, and use of protective equipmen…

Colony-Stimulating Factor-1

A noninvasive means to predict the onset and recurrence of lupus nephritis (LN) before overt renal injury is needed to optimize and individualize treatment. Colony-stimulating factor-1 (CSF-1) is expressed by kidney tubules at the onset of LN, increases with disease progression, and spills into the circulation in lupus-prone mice. We tested the hypothesis that amplified expression of CSF-1 detected in the serum or urine correlates with intrarenal CSF-1 expression and histopathology (increased macrophage accumulation, activity indices) and clinical kidney disease activity and predicts the onset and recurrence of nephritis in patients with systemic lupus erythematosus (SLE). We found increase…

Incidence and time trends of soft tissue sarcomas in German children 1985-2004 - a report from the population-based German Childhood Cancer Registry.

Abstract The incidence of soft tissue sarcoma (STS) in Europe is increasing, but it is unclear whether this increase can also be seen in Germany. We analysed the heterogeneous group of STS recorded to the German Childhood Cancer Registry (GCCR) between 1985 and 2004 with respect to incidence data. Age-specific, age-standardised and cumulative incidence rates were calculated. Additionally, the average annual percent change (AAPC), derived from a Poisson regression model, was estimated, using time in years as the explanatory, continuous variable. Two thousand sixty-one children were diagnosed at a median age of 72 months. Most common are rhabdomyosarcomas (RMS) (n = 1202) and fibrosarcomas (n…

Prevalence of Wine Intolerance

Background Wine is an ancient food product, ubiquitous across cultures all over the world. Its effects on health have been extensively studied, yet there have been only a few case reports of wine intolerance or wine allergy. We studied the prevalence of self-reported wine intolerance in the adult population of Mainz, Germany.

Symptoms of depersonalization/derealization are independent risk factors for the development or persistence of psychological distress in the general population: Results from the Gutenberg health study

Abstract Background Symptoms of depersonalization (DP) and derealization (DR) have a high prevalence in patient and community samples. Previous studies suggested that DP/DR symptoms might represent a marker of disease severity and poor prognosis. However, population-based studies investigating the impact of DP/DR symptoms on the course of depression and anxiety are sparse. Therefore, we aimed to analyze whether symptoms of DP/DR are longitudinally associated with the persistence or incidence of elevated symptoms of depression/anxiety. Methods We analyzed observational data from a sample of 13.182 participants of the Gutenberg Health Study. The outcomes were elevated symptoms of depression/a…

Descriptive Statistics

A set of medical data is based on a collection of the data of individual cases or objects, also called observation units or statistical units. Every case, for example every study participant, patient, every experimental animal, every tooth or every cell shows comparable parameters (such as body weight, gender, erosion, pH). Each of these parameters, also called variables, has a specific parameter value (gender = male, age = 30 years, weight = 70 kg) for each observation unit (for example the patient). The aim of descriptive statistics is to summarize the data, so that they can be clearly illustrated (1–3). The property of a parameter is specified by its so-called scale of measure. Generally…

Type D personality as a cardiovascular risk marker in the general population: results from the Gutenberg health study.

&lt;i&gt;Background:&lt;/i&gt; Type D personality is considered as an independent risk factor for morbidity and mortality in cardiovascular patients and a vulnerability factor for distress in the general population. Because representative community studies are rare, we sought to determine the prevalence of type D personality and its relationship with demographic characteristics, different features of mental disorders, cardiovascular risk factors, health behavior, endothelial function and cardiovascular biomarkers in the general population. &lt;i&gt;Methods:&lt;/i&gt; The prevalence of type D personality and its correlates were analyzed cross-sectionally in a population-based sample of 5,000…

Feasibility of a cohort study on health risks caused by occupational exposure to radiofrequency electromagnetic fields.

Abstract Background The aim of this study was to examine the feasibility of performing a cohort study on health risks from occupational exposure to radiofrequency electromagnetic fields (RF-EMF) in Germany. Methods A set of criteria was developed to evaluate the feasibility of such a cohort study. The criteria aimed at conditions of exposure and exposure assessment (level, duration, preferably on an individual basis), the possibility to assemble a cohort and the feasibility of ascertaining various disease endpoints. Results Twenty occupational settings with workers potentially exposed to RF-EMF and, in addition, a cohort of amateur radio operators were considered. Based on expert ratings, l…

Qualitätssicherung in einer epidemiologischen Kohortenstudie: Durchführung von on-site Monitoring in gynäkologischen Arztpraxen

Quality assurance is required for all relevant instruments and procedures in epidemiological studies just like for clinical trials. The structure and complexity of the monitoring was developed based on the monitoring in clinical trials and applied to an epidemiological cohort study on early detection of cervical cancer (MARZY Study). Analyses of the on-site monitoring in participating gynaecological practices during the baseline investigation of the MARZY cohort were presented. The baseline investigation of the MARZY study was conducted between 2005 and 2007 in the city of Mainz, the rural district of Mainz-Bingen and surrounding areas. Women, who were randomly selected via population regis…

Is the p-Value a Suitable Basis for the Construction of Measures of Evidence? Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”

Dr. Gibson has to be congratulated for having enriched the wealth of articles written in response to the ASA statement on p-values of 2016 by a valuable and thoughtful contribution. We particularly...

Systematic Literature Reviews and Meta-Analyses

SUMMARY Background: Because of the rising number of scientific publications, it is important to have a means of jointly summarizing and assessing different studies on a single topic. Systematic literature reviews, meta-analyses of published data, and meta-analyses of individual data (pooled reanalyses) are now being published with increasing frequency. We here describe the essential features of these methods and discuss their strengths and weaknesses. Methods: This article is based on a selective literature search. The different types of review and meta-analysis are described, the methods used in each are outlined so that they can be evaluated, and a checklist is given for the assessment of…

Linear Regression Analysis

SUMMARY Background: Regression analysis is an important statistical method for the analysis of medical data. It enables the identification and characterization of relationships among multiple factors. It also enables the identification of prognostically relevant risk factors and the calculation of risk scores for individual prognostication. Methods: This article is based on selected textbooks of statistics, a selective review of the literature, and our own experience. Results: After a brief introduction of the uni- and multivariable regression models, illustrative examples are given to explain what the important considerations are before a regression analysis is performed, and how the resul…

Additional file 7 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 7: Gene expression in the "Not a Number" pathways (blue = downregulation, red = upregulation). Web Figure 14. Base excision repair (BER) system. Web Fig. 15. Molecular mechanisms of cancer. Web Fig. 16. Assembly of RNA polymerase III complex. Web Fig. 17. DNA double-strand break repair by homologous recombination. Web Fig. 18. Interleukin 4 (IL-4) signaling. Web Fig. 19. Interleukin 17 (IL-17) signaling. Web Fig. 20. Interleukin 17A (IL-17A) signaling in fibroblasts. Web Fig. 21. Mitochondrial dysfunction. Web Fig. 22. Myc mediated apoptosis signaling. Web Fig. 23.Nucleotide excision repair. Web Fig. 24. Protein ubiquitination. Web Fig. 25. Retinoic acid receptor (RAR) activ…

Additional file 4 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 4: Web Figure 11. Comparison of affected pathways in different data sets.

Assessing Planning Ability Across the Adult Life Span: Population-Representative and Age-Adjusted Reliability Estimates for the Tower of London (TOL-F).

Planning ahead the consequences of future actions is a prototypical executive function. In clinical and experimental neuropsychology, disc-transfer tasks like the Tower of London (TOL) are commonly used for the assessment of planning ability. Previous psychometric evaluations have, however, yielded a poor reliability of measuring planning performance with the TOL. Based on theory-grounded task analyses and a systematic problem selection, the computerized TOL-Freiburg version (TOL-F) was developed to improve the task's psychometric properties for diagnostic applications. Here, we report reliability estimates for the TOL-F from two large samples collected in Mainz, Germany (n = 3,770; 40-80 y…

Generating survival times to simulate Cox proportional hazards models by Ralf Bender, Thomas Augustin and Maria Blettner,Statistics in Medicine 2005;24:1713–1723

Genetic associations at 53 loci highlight cell types and biological pathways relevant for kidney function

Reduced glomerular filtration rate defines chronic kidney disease and is associated with cardiovascular and all-cause mortality. We conducted a meta-analysis of genome-wide association studies for estimated glomerular filtration rate (eGFR), combining data across 133,413 individuals with replication in up to 42,166 individuals. We identify 24 new and confirm 29 previously identified loci. Of these 53 loci, 19 associate with eGFR among individuals with diabetes. Using bioinformatics, we show that identified genes at eGFR loci are enriched for expression in kidney tissues and in pathways relevant for kidney development and transmembrane transporter activity, kidney structure, and regulation o…

History of depression but not current depression is associated with signs of atherosclerosis: data from the Gutenberg Health Study.

ObjectivesTo test the vascular depression hypothesis in the general population, we analyzed the association between current depression, medical history of depression, cognitive and somatic depressive symptom dimensions and measures of atherosclerosis [intima–media thickness (IMT) and carotid plaques].MethodWe included a representative sample of 5000 participants from the Gutenberg Health Study (GHS). Depression was assessed by the nine-item Patient Health Questionnaire (PHQ-9), and IMT and carotid plaques were measured at both common carotid arteries using an edge detection system. Regression analyses were performed separately for participants with and without cardiovascular disease, adjust…

Radiation dose distribution in functional heart regions from tangential breast cancer radiotherapy

Abstract Background and purpose To analyze the distribution of individually-determined radiation dose to the heart and its functional sub-structures after radiotherapy in breast cancer patients treated in Germany during 1998–2008. Material and methods We obtained electronic treatment planning records for 769 female breast cancer patients treated with megavoltage tangential field radiotherapy. All dose distributions were re-calculated using Eclipse with the anisotropic analytical algorithm (AAA) for photon fields, and the electron Monte Carlo algorithm for electron boost fields. Based on individual dose volume histograms for the complete heart and several functional sub-structures, we estima…

Avoiding Bias in Observational Studies

Background Many questions in human health research can only be answered with observational studies. In contrast to controlled experiments or well-planned, experimental randomized clinical trials, observational studies are subject to a number of potential problems that may bias their results.

Telephone Consultation

The article by Martina Albrecht and her co-authors (1) addresses an important aspect of patient-oriented medical decision making in Germany: to what extent does the advice dispensed by the freely accessible telephone consultation services correspond with the evidence? In other words: Can people who turn to these services understand and trust the information they are given? Only six of 293 consultations fulfilled the criteria defined by the authors—on the face of it, an alarming outcome.

Eight-year trends in food, energy and macronutrient intake in a sample of elderly German subjects.

Time trends in the food and the corresponding energy and macronutrient intake between 1994 and 2002 are investigated as part of the longitudinal study on nutrition and health status in an ageing population in Giessen, Germany (GISELA study). The dietary intake is assessed via a 3 d estimated dietary record especially developed and validated for this study. A total of 2135 records from 532 subjects, aged 60 years and over, are analysed separately according to sex and age groups (born 1904–1928 and born 1929–1942). Results show that the food, energy and macronutrient intake of the GISELA subjects stayed fairly stable over the study period. However, some significant changes in the consumption …

Additional file 11 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 11: Web Table 1D. Differentially expressed genes 4 h after exposure to high dose ionizing radiation (2 Gray).

Occupational solvent exposure and risk of glioma in the INTEROCC study

BACKGROUND: The aetiology of glioma remains largely unknown. Occupational solvent exposure has been suggested as a putative cause of glioma, but past studies have been inconsistent. We examined the association between a range of solvents and glioma risk within the INTEROCC project, a study of brain tumours and occupational exposures based on data from seven national case-control studies conducted in the framework of the INTERPHONE study. We also investigated associations according to tumour grade.METHODS: Data from the seven countries were standardised and then combined into one aggregate data set. Pooled odds ratios (ORs) were estimated for adjusted models that included sex, age, country-r…

Additional file 12 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 12: Web Table 2. Differential expression activity in cellular pathways and involved molecules

Environmental risk factors for sporadic acoustic neuroma (Interphone Study Group, Germany)

The only known risk factor for sporadic acoustic neuroma is high-dose ionising radiation. Environmental exposures, such as radiofrequency electromagnetic fields and noise are under discussion, as well as an association with allergic diseases. We performed a population-based case-control study in Germany investigating these risk factors in 97 cases with acoustic neuroma, aged 30 to 69 years, and in 194 matched controls. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated in multiple logistic regression models. Increased risks were found for exposure to persistent noise (OR=2.31; 95% CI 1.15-4.66), and for hay fever (OR=2.20; 95% CI 1.09-4.45), but not for ionising radiation …

Clinical Determinants of Thrombin Generation Measured in Presence and Absence of Platelets-Results from the Gutenberg Health Study.

AbstractThe tendency of a plasma sample to generate thrombin, a central enzyme in blood coagulation, might be an important indicator of prothrombotic risk linked to cardiovascular disease (CVD), but the presence of platelets may be a critical determinant. Clinical data, laboratory markers and thrombin generation (TG), investigated in both platelet-rich plasma (PRP) and platelet-free plasma (PFP) at 1 pM TF, were available in 407 individuals from the Gutenberg Health Study. Given the well-known effect of anticoagulants on TG, subjects taking anticoagulants (n = 15) have been excluded resulting in 392 subjects for further analysis. Lag time, endogenous thrombin potential (ETP) and peak height…

Vitamin D Insufficiency In Adult Asthma Is Associated With Asthma Severity And Control

Data in asthmatic children suggest that low vitamin D levels are associated with poor asthma control, reduced lung function, and increased medication intake. To investigate the role of vitamin D insufficiency in adult asthmatics 25-hydroxyvitamin D was measured in 280 adult patients with asthma (mean±SEM: 45.0±0.8 yrs., 40% male, FEV1 74.9±1.4%) and correlated with clinical parameters of asthma control. The majority of patients had severe asthma (n=155, 55%) and were uncontrolled (n=144, 51%). Serum levels of vitamin D were significantly related to asthma severity (mean±SEM: intermittent 31.1±3.2 ng/ml, mild 27.3±1.6 ng/ml, moderate 26.5±1.5, severe 24.0±0.9, p=0.046) and asthma control (co…

Psychological distress in lung cancer survivors at least 1 year after diagnosis-Results of a German multicenter cross-sectional study.

Cancer risk among residents of Rhineland-Palatinate winegrowing communities: a cancer-registry based ecological study

Abstract Aim To investigate the cancer risk among residents of Rhineland-Palatinate winegrowing communities in an ecological study. Methods On the basis of the Rhineland-Palatinate cancer-registry, we calculated age-adjusted incidence rate ratios for communities with a medium area under wine cultivation (&gt;5 to 20 percent) and a large area under wine cultivation (&gt;20 percent) in comparison with communities with a small area under wine cultivation (&gt;0 to 5 percent). In a side analysis, standardized cancer incidence ratios (SIR) were computed separately for winegrowing communities with small, medium and large area under wine cultivation using estimated German incidence rates as refere…

Codierung der Tätigkeitsangaben im Basiskollektiv der Gutenberg-Gesundheitsstudie unter Anwendung der Klassifikation der Berufe KldB 2010 — Darstellung des Vorgehens und der Datenqualität

In der Basiserhebung der Gutenberg- Gesundheitsstudie Mainz wurden die Berufsbiografien von 15.010 Probanden erfasst. Um die Textangaben aus 67.389 einzelnen Tatigkeitsphasen fur epidemiologische Auswertungen nutzen zu konnen, wurde eine Codierung nach der deutschen Klassifikation der Berufe KldB 2010 durchgefuhrt. Ziel des Artikels ist, das methodische Vorgehen und die Qualitat der angewandten Berufscodierung darzustellen.

Mortality from cancer and other causes in commercial airline crews: a joint analysis of cohorts from 10 countries.

Background Commercial airline crew is one of the occupational groups with the highest exposures to ionising radiation. Crew members are also exposed to other physical risk factors and subject to potential disruption of circadian rhythms. Methods This study analyses mortality in a pooled cohort of 93 771 crew members from 10 countries. The cohort was followed for a mean of 21.7 years (2.0 million person-years), during which 5508 deaths occurred. Results The overall mortality was strongly reduced in male cockpit (SMR 0.56) and female cabin crews (SMR 0.73). The mortality from radiation-related cancers was also reduced in male cockpit crew (SMR 0.73), but not in female or male cabin crews (SMR…

Participation in cervical cancer screening in Germany.

Additional file 13 of Comparison of time and dose dependent gene expression and affected pathways in primary human fibroblasts after exposure to ionizing radiation

Additional file 13: Supplement file 1. Settings for comparison analyses in IPA.

Distinctiveness and overlap of depersonalization with anxiety and depression in a community sample: results from the Gutenberg Heart Study.

Depersonalization disorder is considered to be a common clinical phenomenon and disorder with an enormous gap between prevalence and detection partly due to the common interpretation of depersonalization (DP) being a negligible variant of anxiety and depression. Therefore, we sought to analyze (1) the prevalence rate of DP in a large community sample (n=5000) according to a recently developed ultra brief two-item depersonalization screener; (2) the associations with depression, anxiety, physical and mental health status; and 93) whether DP contributes independently to the health status beyond anxiety and depression. The prevalence of clinically significant DP was 0.8% (n=41), and 8.5% (n=42…

Self-reported consumption of wine and other alcoholic beverages in a German wine area

Petra Fronk,1 Maria Blettner,2 Heinz Decker1 1Institute for Molecular Biophysics, Johannes Gutenberg University of Mainz, Mainz, Germany; 2Institute for Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg University of Mainz, Mainz, Germany Purpose: To describe the consumption of alcoholic beverages in a German wine area, with special attention to the number of people drinking more than the tolerable upper alcohol intake level (TUAL). Methods: A cross-sectional study was conducted using a mailed questionnaire, to investigate the weekly consumption of wine, beer, and spirits during the preceding 12 months in Mainz, the state capital of Rhineland-Palatinate, Germany. The a…

Probability of hysterectomy in Germany

Introduction Hysterectomy is the most common gynecological surgery in many industrialized countries. In Germany, the hysterectomy rate is high in comparison to other European countries. The aim of this analysis was to determine the distribution of age at hysterectomy as well as the age-specific probability of undergoing a hysterectomy between the ages of 0–64 in the German female population. Methods Analyses were based on data from the MARZY study, a prospective, randomized, population-based cohort study investigating early detection of cervical cancer in western Germany. At baseline, 6429 women were invited to attend cervical cancer screening. The distribution of age at hysterectomy as wel…

Long-term Oncologic Outcome After Transanal Endoscopic Microsurgery for Rectal Carcinoma

Transanal endoscopic microsurgery is superior to other methods of local excision of rectal cancer, but few studies report long-term follow-up data.This study investigated the use of transanal endoscopic microsurgery alone as curative and compromise therapy based on long-term disease recurrence and mortality.This was a retrospective review of prospectively collected data.The study was conducted at a tertiary care university medical center.The study included 133 patients treated between 1985 and 2007. There were 3 groups, including transanal endoscopic microsurgery in curative intent (low-risk rectal carcinoma, including pT1, G1/2, L0, and LX with clear margins and a minimal distance between …

How Do Cancer Registries in Europe Estimate Completeness of Registration?

Summary Objectives: Several methods for estimating completeness in cancer registries have been proposed. Little is known about their relative merits. Before embarking on a systematic comparison of methods we wanted to know which indicators were currently in use and whether there had been comparative investigations of estimation methods. Methods: We performed a survey among European cancer registries asking which methods for estimating completeness they used and whether they had performed comparisons of methods. Results: One hundred and ninety-five European cancer registries were contacted after identification using membership directories of the European Network of Cancer Registries (ENCR) a…

Long-term effect of arsenic exposure: Results from an occupational cohort study

Background In 1976 in Manfredonia (Italy), arsenic was released into the atmosphere due to an accident in a petrochemical plant. We aimed to analyze the mortality of workers involved in the factory for the site cleaning activities. Methods The cohort consisted of 1467 workers grouped into contract, fertilizer, and plastic workers. The outcome of interest was mortality for specific causes. Standardized mortality ratios (SMR) and 95% confidence intervals (95%CI) were computed. Results For all workers and all causes of death combined, the SMR was less than 1.0. Mortality ratios were increased for malignant neoplasms of the pleura, bone and melanoma of the skin. Contract workers, the group most…

Biologically based models of cancer risk in radiation research

Biologically based models of cancer risk in radiation research

Biologically-based models of cancer risk in radiation research

Purpose: In radiation risk analysis the state-of-the-art approach is based on descriptive models which link excess rates of cancer incidence and mortality to radiation exposure by statistical association. To estimate the number of sporadic and radiation-induced cases descriptive models apply parametric dose response function which directly determine the radiation risk. In biologically-based models of cancer risk (BBCR models) dose responses are implemented for key events on the biological level such as early mutations or clonal expansion of initiated cells. Influenced by radiation these events then shape the risk response on the epidemiological level. Although BBCR models facilitate a more …