title: Estimate of false-positive breast cancer diagnoses from accuracy studies: a systematic review.
abstract: 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.
  
  
  RESULTS
  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.
authors.affiliation: Department of Cancer Screening, Centre for Epidemiology and Prevention in Oncology (CPO), University Hospital "Città della Salute e della Scienza di Torino", Turin, Italy.
authors.forename: Nereo
authors.initials: N
authors.lastname: Segnan
authors.affiliation: Department of Cancer Screening, Centre for Epidemiology and Prevention in Oncology (CPO), University Hospital "Città della Salute e della Scienza di Torino", Turin, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Minozzi
authors.affiliation: Department of Cancer Screening, Centre for Epidemiology and Prevention in Oncology (CPO), University Hospital "Città della Salute e della Scienza di Torino", Turin, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Ponti
authors.affiliation: Department of Cancer Screening, Centre for Epidemiology and Prevention in Oncology (CPO), University Hospital "Città della Salute e della Scienza di Torino", Turin, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Bellisario
authors.affiliation: Department of Cancer Screening, Centre for Epidemiology and Prevention in Oncology (CPO), University Hospital "Città della Salute e della Scienza di Torino", Turin, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Balduzzi
authors.affiliation: Department of Cancer Screening, Centre for Epidemiology and Prevention in Oncology (CPO), University Hospital "Città della Salute e della Scienza di Torino", Turin, Italy.
authors.forename: Marien
authors.initials: M
authors.lastname: González-Lorenzo
authors.affiliation: IRCCS Galeazzi Orthopaedic Institute, Unit of Clinical Epidemiology, Milan, Italy.|Center of Biostatistics for Clinical Epidemiology, School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Gianola
authors.affiliation: Department of Cancer Screening, Centre for Epidemiology and Prevention in Oncology (CPO), University Hospital "Città della Salute e della Scienza di Torino", Turin, Italy.
authors.forename: Paola
authors.identifier: http://orcid.org/0000-0001-8965-4307
authors.initials: P
authors.lastname: Armaroli
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis*; D005189:False Positive Reactions; D005260:Female; D006801:Humans
keywords: BREAST CANCER; DIAGNOSIS; EPIDEMIOLOGY