title: Conclusions for mammography screening after 25-year follow-up of the Canadian National Breast Cancer Screening Study (CNBSS).
abstract: Twenty-five-year follow-up data of the Canadian National Breast Cancer Screening Study (CNBSS) indicated no mortality reduction. What conclusions should be drawn? After conducting a systematic literature search and narrative analysis, we wish to recapitulate important details of this study, which may have been neglected: Sixty-eight percent of all included cancers were palpable, a situation that does not allow testing the value of early detection. Randomisation was performed at the sites after palpation, while blinding was not guaranteed. In the first round, this "randomisation" assigned 19/24 late stage cancers to the mammography group and only five to the control group, supporting the suspicion of severe errors in the randomisation process. The responsible physicist rated mammography quality as "far below state of the art of that time". Radiological advisors resigned during the study due to unacceptable image quality, training, and medical quality assurance. Each described problem may strongly influence the results between study and control groups. Twenty-five years of follow-up cannot heal these fundamental problems. This study is inappropriate for evidence-based conclusions. The technology and quality assurance of the diagnostic chain is shown to be contrary to today's screening programmes, and the results of the CNBSS are not applicable to them.
  
  
  CONCLUSIONS
  • The evidence base of the Canadian study (CNBSS) has to be questioned.• Severe flaws in the randomization process and test methods occurred. • Problems were criticized during and after conclusion of the trial by experts.• The results are not applicable to quality-assured screening programs. • The evidence base of this study must be re-analyzed.
authors.affiliation: Ntl. Reference Centre Mammography Munich, Sonnenstr. 29, 80331, Munich, Germany. sylvia.heywang@referenzzentrum-muenchen.de.
authors.forename: S H
authors.initials: SH
authors.lastname: Heywang-Köbrunner
authors.affiliation: Radiologische Allianz Hamburg, Schäferkampsallee 5 - 7, 220357, Hamburg, Germany. ingrid.schreer@hamburg.de.
authors.forename: I
authors.initials: I
authors.lastname: Schreer
authors.affiliation: Ntl. Reference Centre Mammography Munich, Sonnenstr. 29, 80331, Munich, Germany. astrid.hacker@referenzzentrum-muenchen.de.
authors.forename: A
authors.initials: A
authors.lastname: Hacker
authors.affiliation: Institut für Sozialmedizin und Epidemiologie, Universität zu Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. maria.noftz@uksh.de.
authors.forename: M R
authors.initials: MR
authors.lastname: Noftz
authors.affiliation: Institut für Sozialmedizin und Epidemiologie, Universität zu Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. alexander.katalinic@uksh.de.
authors.forename: A
authors.initials: A
authors.lastname: Katalinic
mesh_terms: D001943:Breast Neoplasms / Q000000981:diagnostic imaging*; D002170:Canada; D055088:Early Detection of Cancer / Q000379:methods*; D019317:Evidence-Based Medicine / Q000592:standards; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008327:Mammography / Q000379:methods*; D010173:Palpation; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012107:Research Design
keywords: Breast cancer; Canadian National Breast Cancer Screening Study (CNBSS); Image quality; Mammography screening; Randomization