Reliability and validity of needle biopsy evaluation of breast-abnormalities using the B-categorization – design and objectives of the Diagnosis Optimisation Study (DIOS)

<p>Abstract</p> <p>Background</p> <p>The planned nationwide implementation of mammography screening 2007 in Germany will increase the occurrence of mammographically detected breast abnormalities. These abnormalities are normally evaluated by minimal invasive core biopsy. To minimize false positive and false negative histological findings, quality assurance of the pathological evaluation of the biopsies is essential. Various guidelines for quality assurance in breast cancer diagnosis recommend applying the B-classification for histopathological categorization. However, to date there are only few studies that reported results about reliability and validity of B-classification. Therefore, objectives of our study are to determine the inter- and intraobserver variability (reliability study) and construct and predictive validity (validity study) of core biopsy evaluation of breast abnormalities. This paper describes the design and objectives of the DIOS Study.</p> <p>Methods/Design</p> <p>All consecutive asymptomatic and symptomatic women with breast imaging abnormalities who are referred to the University Hospital of Halle for core breast biopsy over a period of 24 months are eligible. According to the sample size calculation we need 800 women for the study. All patients in the study population underwent clinical and radiological examination. Core biopsy is performed by stereotactic-, ultrasound- or magnetic resonance (MR) guided automated gun method or vacuum assisted method. The histopathologic agreement (intra- and interobserver) of pathologists and the histopathologic validity will be evaluated. Two reference standards are implemented, a reference pathologist and in case of suspicious or malignant findings the histopathologic result of excision biopsy. Furthermore, a self administrated questionnaire which contains questions about potential risk factors of breast cancer, is sent to the participants approximately two weeks after core biopsy. This enables us to run a case-control-analysis (woman with breast cancer histological verified after excision are defined as cases, woman without malignant breast lesions are defined as controls) to investigate the predictive values of various risk factors on breast cancer risk.</p> <p>Conclusion</p> <p>The analysis of reliability and validity of the histopathological evaluation of core biopsy specimens of breast abnormalities is intended to provide important information needed for a high quality in breast cancer diagnostic and for planning of treatment strategies.</p

Impact of the estimation equation for GFR on population-based prevalence estimates of kidney dysfunction

Background: Estimating equations are recommended by clinical guidelines as the preferred method for assessment of glomerular filtration rate (GFR). The aim of the study was to compare population-based prevalence estimates of decreased kidney function in Germany defined by an estimated GFR (eGFR

Prävalenz der eingeschränkten Nierenfunktion

Hintergrund: Die Prävalenz von nichtdialysepflichtigen Nierenfunktionsstörungen bei Erwachsenen in Deutschland ist unbekannt. Ihre Kenntnis ist wichtig zur Abschätzung des Versorgungsbedarfs mit Nierenersatztherapien und von ungenutztem Präventionspotenzial. Auch ist die eingeschränkte Nierenfunktion ein wichtiger kardiovaskulärer Risikofaktor. Bisher wurden US-amerikanische Prävalenzschätzungen trotz begrenzter Vergleichbarkeit häufig auf Deutschland übertragen. Methoden: Ausgewertet wurden Daten zur Nierenfunktion aus der bundesweiten „Studie zur Gesundheit Erwachsener in Deutschland 2008–2011 (DEGS1)“ des Robert Koch-Instituts. Hierzu erfolgte eine Schätzung der glomerulären Filtrationsrate (eGFR) aus Serumkreatinin und Cystatin-C (CKD-EPI-Formel) sowie eine semiquantitative Albuminurie-Bestimmung. Zusammenhänge zwischen einer eingeschränkten Nierenfunktion und möglichen Determinanten wurden mittels adjustierter Prävalenzverhältnisse (PR) und 95-%-Konfidenzintervallen (95-%-KI) quantifiziert. Ergebnisse: Etwa 2,3 % (95-%-KI: [1,9; 2,6 ]) der Menschen im Alter von 18–79 Jahren wiesen eine eGFR 80 Jahre sind bundesweit mindestens 2 Millionen Menschen in Deutschland betroffen. Eine Albuminurie ≥ 30 mg/L weisen 11,5 % der Bevölkerung auf. Diabetes mellitus (PR = 2,25, 95-%-KI: [1,59; 3,16]) und arterielle Hypertonie (PR = 3,46, 95-%-KI: [1,95; 6,12]) sind wichtige Determinanten. Schlussfolgerungen: Erstmals liegt mit diesen Daten eine repräsentative Schätzung der Häufigkeit von Nierenfunktionsstörungen in Deutschland vor. Sie zeigt eine starke Altersabhängigkeit, ist jedoch niedriger, als sie auf der Basis US-amerikanischer Daten für Deutschland bislang angenommen wurde

No evidence for seasonal variations of the incidence of testicular germ cell tumours in Germany.

The pathogenesis of testicular germ cell tumours (GCTs) is still incompletely understood. Any progress in its understanding must derive from observational studies. Recently, it has been suggested that the incidence of GCTs may follow a seasonal pattern based on circannual changes in the Vitamin D serum levels, with maximum incidence rates in winter months. To examine this promising hypothesis, we studied monthly incidence rates of testicular GCTs in Germany by analysing 30,988 GCT cases aged 15-69 years, diagnosed during 2009-2019. Monthly incident case numbers with data regarding histology and patient age were obtained from the Robert Koch Institut, Berlin, along with annual male population counts. We used precision weighting for deriving pooled monthly incidence rates for GCTs of the period 2009-2019. We stratified pooled rates by histology (seminoma and nonseminoma) and age (15-39 and 40-69 years). By assuming a cyclical effect, we used an estimator of the intensity of seasonal occurrence and report seasonal relative risks (RR). The mean monthly incidence rate was 11.93/105 person-months. The seasonal RR for testicular cancer over-all is 1.022 (95% CI 1.000-1.054). The highest seasonal RR was found in the subgroup of nonseminoma aged 15-39 years, with a RR 1.044 (95% CI 1.000-1.112). The comparison of the pooled monthly rates of the winter months (October-March) with the summer months (April-September) revealed a maximum relative difference of 5% (95% CI 1-10%) for nonseminoma, aged 15-39 years. We conclude that there is no evidence of a seasonal variation of incidence rates of testicular cancer. Our results are at odds with an Austrian study, but the present data appear sound because the results were obtained with precision weighted monthly incidence rates in a large population of GCT cases

Age-incidence patterns of seminoma and nonseminoma among males and females in Germany and the United States, 2008–2016

Background & objectives: The comparison of the incidence of gonadal germ cell tumors among males and females can provide insights that cannot be gained by separately studying these tumors. Material and methods: Incidence data on male and female gonadal germ cell tumors were drawn from the cancer registries of North Rhine-Westphalia, Germany, and the United States Surveillance, Epidemiology and End Results program, for non-Hispanic White persons only, for the years 2008–2016. We estimated age-standardized and age-, and histology-specific incidence rates. Results: We included 21,840 male and 716 female gonadal germ cell tumors. Incidence rates among males were higher in Germany (95.8 per million, standard error [SE] 1.1) than in the United States (68.0, SE 0.6), while incidence rates among females were lower in Germany (1.9, SE 0.2) than in the United States (2.6, SE 0.1). The characteristic peak of infantile (age 0–4 years) germ cell tumors among males were missing among females. The age peak of ovarian germ cell tumors occurred 15–20 years earlier (Germany: 10–14 years, United States: 15–19 years) than the age peak of testicular germ cell tumors (30–34 years). The three most common testicular germ cell tumors histologies were seminoma, mixed germ cell tumors, and embryonal carcinoma Among females, the three most common ovarian germ cell tumors histologies were teratoma, yolk sac tumor, monodermal teratomas, and somatic-type tumors arising from dermoid cysts in both countries. Discussion: The characteristic peak of infantile (age 0–4 years) germ cell tumors among males was missing among females. The shapes of the age-specific incidence curves are similar for males and females in Germany and the United States, though with much lower incidence rates in females, suggesting a common pathogenesis. Conclusion: The lower rates among females may be due to the lower number of initiated tumors in the absence of the Y-chromosome, and the earlier peak among females may be due to a younger age at puberty

Additional file 1: Figure S1. of Impact of the estimation equation for GFR on population-based prevalence estimates of kidney dysfunction

Bland-Altman plots for comparison between Full Age Spectrum creatinine equation (FAScre) and the other equations used to estimate GFR among 7001 adults aged 18–79 in Germany 2008–2011 (DEGS1). MDRD: Modification of Diet in Renal Disease study equation; CKD-EPIcre: Chronic Kidney Disease Epidemiology Collaboration creatinine equation; CKD-EPIcys: Chronic Kidney Disease Epidemiology Collaboration cystatin C equation; CKD-EPIcrecys: Chronic Kidney Disease Epidemiology Collaboration creatinine and cystatin C equation; LM: Lund-Malmö equation; FAScre: Full Age Spectrum creatinine equation. Solid, horizontal lines represent the mean difference between the eGFR. Dashed, horizontal lines represent the limit of agreement between the equations. Solid, vertical lines represent the eGFR cut-off value of a decreased kidney function (60 ml/min/1.73m2). (PDF 422 kb

Risk of second primary cancers after testicular cancer in East and West Germany: A focus on contralateral testicular cancers

Testicular cancer survival rates improved dramatically after cisplatin-based therapy was introduced in the 1970s. However, chemotherapy and radiation therapy are potentially carcinogenic. The purpose of this study was to estimate the risk of developing second primary cancers including the risk associated with primary histologic type (seminoma and non-seminoma) among testicular cancer survivors in Germany. We identified 16 990 and 1401 cases of testicular cancer in population-based cancer registries of East Germany (1961-1989 and 1996-2008) and Saarland (a federal state in West Germany; 1970-2008), respectively. We estimated the risk of a second primary cancer using standardized incidence ratios (SIRs) with 95% confidence intervals (95% CIs). To determine trends, we plotted model-based estimated annual SIRs. In East Germany, a total of 301 second primary cancers of any location were observed between 1961 and 1989 (SIR: 1.9; 95% CI: 1.7-2.1), and 159 cancers (any location) were observed between 1996 and 2008 (SIR: 1.7; 95% CI: 1.4-2.0). The SIRs for contralateral testicular cancer were increased in the registries with a range from 6.0 in Saarland to 13.9 in East Germany. The SIR for seminoma, in particular, was higher in East Germany compared to the other registries. We observed constant trends in the model-based SIRs for contralateral testicular cancers. The majority of reported SIRs of other cancer sites including histology-specific risks showed low precisions of estimated effects, likely due to small sample sizes. Testicular cancer patients are at increased risk especially for cancers of the contralateral testis and should receive intensive follow-ups