Page 129 - Screening for Cervical Cancer: Systematic Evidence Review

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
19,805 Pap smears with No. of FN/No. FN yield (single cytologist): Quality Score=5
2 negative manual rescreened 212/19805 (1.1%) Ref. Std: 0
screens Blind: 0
GS: cytology (panel). FN yield (cytology panel): Verification: 1
No verification of 162/212 (0.82%) Consecutive: 1
rescreen negatives. Spectrum: 1
Histologic validation of FN yield (histology): Publication: 1
some rescreen 14/26 high-grade and 33/102 Industry: 1
positives low-grade abnormalities
histologically confirmed

5478 consecutive Pap No. FN/No. Papnet identified 1614 (29%) Quality Score=5
smears read as normal rescreened of slides requiring review; Ref. Std: 0
or benign cell changes 1166 because no endocervical Blind: 0
on initial and random GS: cytology component was identified. Verification: 1
rescreening (independent panel). 448 (8% of total) Only 11 Consecutive: 1
Verification of cases demonstrated abnormal Spectrum: 1
discrepant cases only cells (5 ASCUS, 1 AGUS, 6 Publication: 1 Industry: 1
LSIL+) 11/5478 (0.2%)

2,200 archival slides All Pap results: Prevalence (artificially set): Quality Score=
selected: 2000 normals, Bethesda method LSIL=52/2195=2.4% 7
200 abnormals HSIL=62/2195=2.8% Ref. Std:1
Reference standard: Ca=39/2195=1.8% Blind:2
Negative, Verification:1
ASCUS/AGUS, LSIL, Se (ASCUS/AGUS, Consecutive:0
HSIL, Ca LSIL+)=72.7% Spectrum:1
Sp (ASCUS/AGUS, Publication:1
LSIL+)=99.4% Industry:1

Se (LSIL, LSIL+)=87.2%
Sp (LSIL, LSIL+)=99.9%

Se (HSIL, HSIL+)=98.2%
Sp (HSIL, HSIL+)=99.9%

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