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Estimate of false-positive breast cancer diagnoses from accuracy studies: a systematic review
  1. Nereo Segnan1,
  2. Silvia Minozzi1,
  3. Antonio Ponti1,
  4. Cristina Bellisario1,
  5. Sara Balduzzi1,
  6. Marien González-Lorenzo1,
  7. Silvia Gianola2,3,
  8. Paola Armaroli1
  1. 1Department of Cancer Screening, Centre for Epidemiology and Prevention in Oncology (CPO), University Hospital “Città della Salute e della Scienza di Torino”, Turin, Italy
  2. 2IRCCS Galeazzi Orthopaedic Institute, Unit of Clinical Epidemiology, Milan, Italy.
  3. 3Center of Biostatistics for Clinical Epidemiology, School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
  1. Correspondence to Dr Paola Armaroli, Department of Cancer Screening, Centre for Epidemiology and Prevention in Oncology (CPO), University Hospital “Città della Salute e della Scienza di Torino”, Via Cavour 31, Turin 10123, Italy; paola.armaroli{at}


Background False-positive histological diagnoses have the same consequences of overdiagnosis in terms of unnecessary treatment. The aim of this systematic review is to assess their frequency at needle core biopsy (CB) and/or surgical excision of the breast.

Methods PubMed, Embase, Cochrane Library were systematically searched up to 30 October 2015. Eligibility criteria: cross-sectional studies assessing diagnostic accuracy of CB compared with surgical excision; studies assessing reproducibility of pathologists reading the same slides. Outcomes: false-positive rates; Misclassification of Benign as Malignant (MBM) histological diagnosis; K statistic. Independent reviewers extracted data and assessed quality using an adapted QUADAS-2 tool.

Results Sixteen studies assessed CB false-positive rates. In 10 studies (41 989 screen-detected lesions), the range of false-positive rates was 0%–7.1%. Twenty-seven studies assessed pathologists' reproducibility. Studies with consecutive, random or stratified samples of all the specimens: at CB the MBM range was 0.25%–2.4% (K values 0.83–0.98); at surgical excision, it was 0.67%–1.2% (K values 0.86–0.94). Studies with enriched samples: the MBM range was 1.4%–6.2% (K values 0.57–0.86). Studies of cases selected for second opinion: the MBM range was 0.29%–12.2% (K values 0.48 and 0.50).

Conclusions High heterogeneity of the included studies precluded formal pooling estimates. When considering studies of higher sample size or methodological quality, false-positive rates and MBM are around 1%. The impact of false-positive histological diagnoses of breast cancer on unnecessary treatment, as well as that of overdiagnosis, is not negligible and is of importance in clinical practice.


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  • Correction notice This article has been corrected since it was published Online First. Author, Silvia Gianola's affiliations has been corrected.

  • Handling editor Cheok Soon Lee

  • Contributors All the authors contributed in conceptualising the work, performing abstract and full-text review, synthesising the results and drafting and reviewing the manuscript. NS: developed the hypothesis of the study. PA, AP: contributed to study concept. SM: coordinated and revised the review process. CB: performed the literature search. SB: statistical support. SM, CB, PA, MG-L, SG: screened articles for inclusion, abstracted and synthesised data, assessed the methodological quality.

  • Funding This work was supported by the Centre for Epidemiology and Prevention in Oncology—Piedmont (year 2014, N. 188), National Health Service.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Technical appendices are available from the corresponding author at