Page 133 - Screening for Cervical Cancer: Systematic Evidence Review
P. 133

Appendix C.  Evidence Tables



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

                                                               Study Results &
                 Patients & Methods  Outcomes Measured           Limitations*         Quality Considerations
                ThinPrep 2000
               35,560 pairs received   No blind interpretation All discrepant results reviewed Quality Score=1.5
               from 500 practitioners                     by independent             Ref. Std: 0
               who chose to offer    Conventional smear   cytopathologist            Blind: 0
               ThinPrep along with   and ThinPrep                                    Verification: 0
               conventional smear.   thresholds of minor   Most of HSIL and inconclusive  Consecutive: 0
               24% of women          changes/HPV, LSIL,  results on either ThinPrep or  Spectrum: 0 Publication: 1
               undergoing screening   inconclusive        conventional smear had     Industry: .5
               pap, and 35% of       abnormality, HSIL,   histologic confirmation
               women needing referral  cytologic reference
               pap had both samples  standard for test    No test negatives verified, or
               taken                 negatives.  Histologic  those with LSIL
                                     reference standard for
                                     those with HSIL or   Relative True Positive rate
                                     inconclusive results   (ThinPrep)=178/158=1.13
                                     on either conventional
                                     smear or ThinPrep    Relative False Positive
                                                          rate(ThinPrep)=37/33=1.12





               39,408 conventional   No blind interpretation Screening test:  ThinPrep   Quality Score=4
               Paps, and 10,694                           Prevalence(not specified)=   Ref. Std: 2
               ThinPrep specimens,   Pap and ThinPrep     42/54=78%                  Blind: 0
               collected concurrently   specimen with     Se (LSIL,NS)=40/42=95%     Verification: 0
               in two patient        threshold of LSIL    Sp (LSIL,NS)=7/12=58%      Consecutive: 0
               populations, described                                                Spectrum: 0
               only by age           GS:  histology with   Screening test: Pap       Publication: 1
                                     threshold of "positive" Prevalence(NS)=67/89=75%  Industry: 1
                                                          Se (LSIL,NS)=57/67=85%
                                                          Sp (LSIL,NS)=8/22=36%






























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