Replication Data for: Quality control of cervical cytology using a 3-type HPV mRNA test increases screening program sensitivity of cervical intraepithelial neoplasia grade 2+ in young Norwegian women – a cohort study

The dataset comprise the variables necessary to replicate the results published.
Abstract: Within 2021, Norway intends to complete implementation of HPV DNA-based primary screening for cervical cancer for women 34-69 years, while continue cytology-based screening for women 25-33 years. Over the recent years, the incidence of cervical cancer has increased by 30% among women younger than 40 years. In this subset of women, nearly 30% were diagnosed with a normal smear, as most recent smear, prior the cancer diagnosis. This observation demands quality control of normal smears. The aim of this study was to assess increase in program sensitivity of CIN2+ after follow-up of women with false negative Pap-smears testing positive for a 3-type (-16, -18, -45) HPV mRNA test in a cohort design over one screening interval. 521 women, aged 23-39 years, and no prior history of CIN1+ or HSIL, with an ASC-US or worse smear (ASC-US+) and 1444 women with normal screening cytology comprised the study cohorts. The positivity rate for the 3-type HPV mRNA was 1.9% (28/1444). Rescreening revealed 23 women with ASC-US, two women with LSIL, two women with ASC-H, and one woman with AGUS. If the HPV mRNA-positivity rate and histology findings from samples rescreened were applied to all women with normal cytology, an estimated increase in screening sensitivity of 16.4% (95% CI:15.3 -17.5) for CIN2+ and 17.3% (95% CI:16.2-18.4) for CIN3+ were achieved. By rescreening less than 2% of women with normal cytology positive for a 3-type HPV mRNA test, we achieved a significant increase in screening program sensitivity.

本数据集包含了复现所发表结果所需的所有变量。摘要：在2021年，挪威计划完成对34至69岁女性基于HPV DNA的初级筛查以预防宫颈癌，同时对25至33岁女性继续进行基于细胞学的筛查。近年来，40岁以下女性宫颈癌的发病率上升了30%。在此亚组女性中，近30%在癌症诊断前的最近一次涂片检查中被诊断为正常，这一观察结果要求对正常涂片进行质量控制。本研究的目的是评估在一项队列设计中，对连续两次筛查间隔期间Pap-smear检查结果为假阴性的女性进行随访，并在CIN2+的筛查敏感性方面所取得的提高。研究纳入了521名23至39岁、无CIN1+或HSIL病史、ASC-US或更差的涂片（ASC-US+）的女性以及1444名筛查细胞学结果正常的女性。3型HPV mRNA的阳性率为1.9%（28/1444）。复筛结果显示，有23名女性ASC-US，两名女性LSIL，两名女性ASC-H，以及一名女性AGUS。如果将复筛中HPV mRNA阳性率和组织学检查结果应用于所有正常细胞学检查的女性，则估计CIN2+的筛查敏感性提高了16.4%（95% CI：15.3-17.5），CIN3+的筛查敏感性提高了17.3%（95% CI：16.2-18.4）。通过对正常细胞学且3型HPV mRNA测试结果为阳性的女性进行复筛，我们实现了筛查程序敏感性的显著提高。