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

Autor: Thomas Loening, Tilmann Lantzsch, Alexander Kluttig, Andrea Schmidt-Pokrzywniak, Thomas Decker, Pietro Trocchi, Hans-Juergen Holzhausen, Steffen Hauptmann, Andreas Stang, Christoph Thomssen, Joerg Buchmann, A. Heinig, Werner Boecker, Christiane Taege
Rok vydání: 2007
Předmět:
medicine.medical_specialty
Cancer Research
Breast imaging
Breast Neoplasms
lcsh:RC254-282
Sensitivity and Specificity
Diagnosis
Differential
Stereotaxic Techniques
Breast Diseases
Study Protocol
Breast cancer
Germany
Biopsy
medicine
Genetics
Mammography
Humans
Mass Screening
False Positive Reactions
False Negative Reactions
Mass screening
Retrospective Studies
Observer Variation
medicine.diagnostic_test
business.industry
Carcinoma in situ
Biopsy
Needle
Carcinoma
Ductal
Breast
Calcinosis
Reproducibility of Results
Reference Standards
medicine.disease
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Immunohistochemistry
Surgery
Carcinoma
Lobular
Carcinoma
Intraductal
Noninfiltrating
Oncology
Stereotaxic technique
Female
Radiology
Differential diagnosis
business
Carcinoma in Situ
Zdroj: BMC Cancer
BMC Cancer, Vol 7, Iss 1, p 100 (2007)
ISSN: 1471-2407
Popis: Background 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. Methods/Design 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. Conclusion 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.
Databáze: OpenAIRE
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