Nationwide registry‐based trial of risk‐stratified cervical screening

Abstract

In well‐screened populations, most cervical cancers arise from small groups of women with inadequate screening. The present study aims to assess whether registry‐based cancer risk assessment could be used to increase screening intensity among high‐risk women. The National Cervical Screening Registry identified the 28,689 women residents in Sweden who had either no previous cervical screening or a screening history indicating high risk. We invited these women by SMS and/or physical letter to order a free human papillomavirus (HPV) self‐sampling kit. The Swedish national HPV reference laboratory performed extended HPV genotyping and referred high‐risk HPV‐positive women to their regional gynecologist. A total of 3691/28,689 (12.9%) women ordered a self‐sampling kit and 10.0% (2853/28,689) returned a sample for testing. Participation among women who had never attended screening was low, albeit improved. Up to 22.5% of women in other high‐risk groups attended. High‐risk HPV types were detected in 8.3% of samples. High‐risk HPV‐positive women (238/2853) were referred without further triaging and severe cervical precancer or cancer (HSIL+) in histopathology were detected in 36/158 (23%) of biopsied women. Repeat invitations gave modest additional participation. Nationwide contacting of women with high risk for cervical cancer with personal invitations to order HPV self‐sampling kits resulted in high yield of detected CIN2+. Further efforts to improve risk‐stratified screening strategies should be directed to improving (i) the precision of the risk‐stratification algorithm, (ii) the convenience for the women to participate and, (iii) ensuring that screen‐positive women are followed‐up.