title: Impact of p16(INK4a) immunohistochemistry staining on interobserver agreement on the diagnosis of cervical intraepithelial neoplasia.
abstract: OBJECTIVE
  This study aimed to compare the interobserver Cohen κ on H&E staining and on H&E plus p16(INK4a) staining of all cervical biopsy specimens in a population-based screening program.
  
  
  METHODS
  All the colposcopy-guided biopsies generated by the routine screening of 23,258 women aged 25 to 64 years were stained with H&E and H&E plus p16. Biopsy specimens were reviewed by six external experts.
  
  
  RESULTS
  The four diagnoses were available in 441 cases. The interobserver κ values were 0.52 (95% confidence interval [CI], 0.45-0.58) and 0.48 (95% CI, 0.42-0.56) with H&E and H&E + p16, respectively, when using a five-group classification (normal, CIN 1, CIN 2, CIN 3, and cancer); adopting a two-group classification (≤CIN 1 and ≥CIN 2), the values were 0.75 (95% CI, 0.66-0.82) and 0.70 (95% CI, 0.61-0.79), respectively.
  
  
  CONCLUSIONS
  The use of p16 on all cervical biopsy specimens in a screening program showed virtually no effect on reproducibility of the histologic diagnosis.
authors: Servizio Interaziendale di Epidemiologia, AUSL Reggio Emilia, Via Amendola 2, 42122, Reggio Emilia, Italy; paolo.giorgirossi@ausl.re.it.
authors: Alberto
authors: A
authors: Pacchiarotti
authors: Simona
authors: S
authors: Galeotti
authors: Paola
authors: P
authors: Bellardini
authors: Francesco
authors: F
authors: Chini
authors: Guido
authors: G
authors: Collina
authors: Paolo
authors: P
authors: Dalla Palma
authors: Bruno
authors: B
authors: Ghiringhello
authors: Vincenzo
authors: V
authors: Maccallini
authors: Fabio
authors: F
authors: Musolino
authors: Giovanni
authors: G
authors: Negri
authors: Roberto
authors: R
authors: Pisa
authors: Ilaria
authors: I
authors: Sabatucci
authors: Paolo
authors: P
authors: Giorgi Rossi
mesh_terms: D000328:Adult; D014408:Biomarkers, Tumor / Q000378:metabolism*; D019941:Cyclin-Dependent Kinase Inhibitor p16 / Q000378:metabolism*; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D008875:Middle Aged; D015588:Observer Variation; D015203:Reproducibility of Results; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000378:metabolism / Q000473:pathology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000378:metabolism / Q000473:pathology
chemical_list: D014408:Biomarkers, Tumor; D019941:Cyclin-Dependent Kinase Inhibitor p16
keywords: Cervical cancer; Cervical intraepithelial neoplasia; Immunohistochemistry; Mass screening; Reproducibility; p16 protein/p16INK4a (cyclin-dependent kinase inhibitor)