Page 127 - Screening for Cervical Cancer: Systematic Evidence Review
P. 127

Appendix C.  Evidence Tables



               Evidence Table 2.  New Methods for Preparing or Evaluating Cervical Cytology (cont'd)

                 Patients & Methods  Outcomes Measured Study Results & Limitations* Quality Considerations
               Papnet
               1200 smears            No. of FN/No.        Papnet  rescreening:        Quality Score=7
               516 with histologically   rescreened        Se(LSIL+) = 26/29 = 89%     Ref. Std: 2
               proven diagnosis; 29 of                                                 Blind: 2
               which had been         GS:  Histological    In primary screening:       Verification: 1
               manually screened as   validation.          2 independent  Papnet reviews  Consecutive: 0
               negative               No validation of test   identified 435 & 469 of 516   Spectrum: 0
                                      negatives            (91% & 84%)                 Publication: 1
                                                                                       Industry: 1
                                                           Manual screening:
                                                           403/561 (78.1%)
                                                           Relative TPR 1.08-1.16
                                                           Papnet compared to manual
                                                           screening



               160 women with         Blind interpretation    Prevalence(CIN1)=69/160=43 Quality Score=10
               colposcopy and biopsy                       %                           Ref. Std: 2
               within 1 year of a smear  Papnet diagnosis   Se (LSIL,CIN1)=26/69=38%   Blind: 2
               initially reported as   (ASCUS/ AGUS, LSIL, Sp (LSIL,CIN1)=84/91=92%    Verification: 2
               ASCUS                  HSIL, Ca)                                        Consecutive: 2
                                                           Prevalence(CIN2/3)=22/160=  Spectrum: 1
                                      GS:  colposcope-     14%                         Publication: 1
                                      directed biopsy      Se (LSIL,CIN2/3)=9/22=41%   Industry: 0
                                      (normal, HPV, CIN 1,  Sp
                                      CIN 2, CIN 3)        (LSIL,CIN2/3)=114/138=83%

                                                           Limitations:  Narrow spectrum
                                                           of disease (ASCUS/AGUS)

               2293 smears underwent  No. of FN/No.        Papnet:                     Quality Score=4
               Papnet rescreening;    rescreened           FN yield (ASCUS+)142/2293   Ref. Std: 0
               13761 underwent                             (6.3%)                      Blind: 0
               manual rescreening     GS:  cytology (single   FN yield (LSIL+) 48/2293   Verification: 1
                                      pathologist).        (2.1%)                      Consecutive: 1
                                      No verification of                               Spectrum: 1
                                      rescreen negatives.   Manual rescreen:           Publication: 1
                                      No histological      FN yield (ASCUS+) 82/13761  Industry: 0
                                      validation           (0.6%)
                                                           FN yield (LSIL+) 36/13761
                                                           (0.3%)


















                                                            C-33
   122   123   124   125   126   127   128   129   130   131   132