Post‐treatment CIN: Randomised clinical trial using hrHPV testing for prediction of residual/recurrent disease

We investigated in a randomised clinical trial whether addition of hrHPV testing (high‐risk human papillomavirus) to cytological follow‐up after treatment for high‐grade CIN (cervical intraepithelial neoplasia 2/3) can lead to a better selection of women at risk for residual/recurrent CIN. We included 210 women with high‐grade CIN undergoing treatment in outpatient clinics in The Netherlands. Follow‐up was based on cytology alone and cytology combined with hrHPV detection. Our primary outcome measurement was improving specificity for residual/recurrent CIN after treatment. Secondary, we compared health‐care costs and impact of individual hrHPV type on the risk of residual/recurrent CIN. Follow‐up by abnormal cytology alone (6, 12 and 24 months after treatment according to the Dutch protocol) showed a lower specificity for detection of residual/recurrent CIN than follow‐up by abnormal cytology and presence of hrHPV (80 vs. 91%, relative risk 0.87 (95% CI 0.77–0.99)). Both methods showed no significant difference in sensitivity ((86 vs. 100%) RR 0.86 (95% CI 0.63–1.16)). Comparing different post hoc modifications in the strategy of combined testing showed similar test characteristics when low‐risk women (normal cytology and hrHPV negative at 6 months) omitted the 12 months visit (specificity 91%, p = 1.00 z = 0.00). Prediction of residual/recurrent CIN by typing of hrHPV could not be confirmed. Total health‐care costs using cytology and hrHPV testing during follow‐up decreased when low‐risk women omit the 12 months visit. Follow‐up after treatment for high‐grade CIN can be improved by combining cytology with hrHPV testing. We advise combined cytology and hrHPV testing at 6, 12 and 24 months after treatment. Low‐risk women may omit the 12 months visit, resulting in cost reduction. © 2008 Wiley‐Liss, Inc.