Cervical Cancer Screening and Human Papillomavirus (HPV ... - KCE

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14 Cervical cancer screening and HPV KCE reports vol.38 Both study design have significant limitations. With split-sample studies, it is difficult to ensure that the two cytology specimens are comparable and this design would seem to lead to bias against LBC since only the material remnant on the sampling device after preparation of a conventional smear can be used for LBC. It is possible that some diagnostic elements included in the CP-split sample are not available anymore for the LBC. In the two-cohort design it has been argued that the historical controls introduce other biases as the comparability of the populations being compared and expectation bias. The other major limitations found in most of the studies evaluating LBC are the lack of comparison of test performance with a gold standard ( blinded colposcopy/biopsy) and study population of women followed-up for a previous abnormal test result rather than women undergoing routine screening. Large, randomized controlled clinical trials need to be conducted. One large randomized trial is currently ongoing in The Netherlands but the results are not yet available. 2.4.2 Performance 2.4.2.1 Test positivity rate of cytological abnormalities Hutchinson, 1991 Hutchinson, 1992 Awen, 1994 Wilbur, 1994 Aponte-C, 1995 Bur, 1995 Laverty, 1995 Sheets, 1995 Ferenczy, 1996 McGoogan, 1996 Tezuka, 1996 Wilbur, 1996 Lee, 1997 Roberts, 1997 Corkill, 1998 Boman, 1999 Hutchinson, 1999 Shield, 1999 Wang, 1999 Monsonego, 2001 Park, 2001 Armstrong, 2002 Biscotti, 2002 Grace, 2002 Luthra, 2002 Ring, 2002 Coste, 2003 Farnsworth, 2003 Harkness, 2003 Malle, 2003 Masumoto, 2003 Confortini, 2004 Combined Figure 1 and Figure 2 present the variation of the test positivity rate ratio for HSIL+ in studies with concomitant CP and LBC testing with respectively ThinPrep (n=32) and AutoCyte/SurePath (n=16). Figure 1. Forest plot of the ratio of the test positivity (defined as HSIL+) of liquid-based cytology over the test positivity of conventional smears derived from studies where both types of smears were prepared from the same women. LBC=ThinPrep Studies with concomitant testing, test+ rate (HSIL+) ThinPrep/CP .3 .5 .67 1 1.5 2 3 Ratio
KCE reports vol.38 Cervical cancer screening and HPV 15 Geyer, 1993 McGoogan, 1996 Sprenger, 1996 Vassilakos, 1996 Bishop, 1997 Laverty, 1997 Takahashi, 1997 Wilbur, 1997 Howell, 1998 Kunz, 1998 Stevens, 1998 Bishop/TriP, 1998 Minge, 2000 Bergeron, 2001 Hessling, 2001 Robyr, 2002 Combined Figure 2. Forest plot of the ratio of the test positivity (defined as HSIL+) of liquid-based cytology over the test positivity of conventional smears derived from studies where both types of smears were prepared from the same women. LBC=AutoCyte/SurePath Studies with concomitant testing, test+ rate (HSIL+) AutoCyte/CP The pooled ratio never was significantly different from unity: 1.02 (95% confidence interval [CI]: 0.97-1.08) for ThinPrep studies and 1.00 (CI: 0.94-1.06) in case of AutoCyte/SurePath. No significant inter-study heterogeneity was observed (p for Q test >0.6). Significantly more LSIL and LSIL+ lesions were found in both LBC systems. Less ASCUS was found in LBC compared to CP, but this difference was not significant. Similar results were found for the other LBC systems, at the exception of Longatto Filho, who reported significantly increased detection rate of ASCUS (ratio: 2.02; 95% CI: 1.94-2.10) using the DNA Cytoliq system 51 . In two-cohort studies, on average, 63% more HSIL is found in ThinPrep preparations (CI: 38-93%) and 46% in AutoCyte/SurePath (CI: 18-81%) compared to CP. As in studies with concomitant testing, also more LSIL is found in LBC, but the ratios are substantially higher in two-cohort studies: ratio of respectively 1.76 (CI: 1.52-2.03) for ThinPrep and 1.52 (CI: 1.31-1.76) in SurePath/AutoCyte. Less ASCUS is detected in LBC. However this difference was marginally non-significant for ThinPrep and nonsignificant for AutoCyte. The inter-study variation was large (p for Q-test always < 0.001). Bergeron, using CYTOscreen, found not significantly more HSIL and significantly more LSIL and ASCUS (ratios of respectively 1.51 (95% CI: 0.95-2.41); 1.27 (95% CI: 1.06-1.53) and 1.44 (95% CI: 1.26-1.65). 2.4.2.2 Positive predictive value .3 .5 .67 1 1.5 2 3 Ratio In concomitant testing studies, the PPV LBC/PPV CP ratio never differed from unity for whatever histological outcome or cytological cut-off, with the exception of AutoCyte at cut-off LSIL+ for an outcome of CIN2+. In this latter case, the pooled PPV of LBC was lower than that of CP (ratio: 0.92; CI: 0.85-1.00). We also pooled the relative PPV from a limited number of 2-cohort studies where the biopsy rate among cytological positive cases was higher than 80% and where the difference in biopsy rates between LBC and CP was less then 10%. Again, the relative PPVs never were significantly lower than one. Moreover, for ThinPrep smears, the PPV
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KCE reports 34 Trastuzumab in Early
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