The clinical course of untreated CIN2 (HPV16/18+) under active monitoring: A protocol of systematic reviews and meta-analysis

Cervical cancer (CC) is one of the most prevalent and fatal cancers among women. Nearly all forms of CC are related to HPV, and 70% of invasive CCs are associated with HPV16 and HPV18. A histologically confirmed case of cervical intraepithelial neoplasia (CIN)2 or a more severe histological diagnosis is considered to be the demarcation point for treatment, but overtreatment will increases the risk of preterm birth in subsequent pregnancies. This study will evaluate the progress of CIN2 (progression, persistence, or regression) in HPV16/18(+) CIN2 patients who were managed conservatively for 3 months. METHODS: PubMed, Cochrane Library, China National Knowledge Infrastructure, Cumulative Index for Nursing and Allied Health Literature (CINAHL), and the Excerpta Medica Database will be searched. We will include studies reporting on women with CIN2 and HPV16/18(+), conservative treatment for 3 to 60 months with disease outcomes including progression (CIN3 or worse), persistence (CIN2), and regression rates (CIN1 or less). The primary outcome will be the progress of CIN2. Two authors will search the relevant literature, extract the data, and assess the risk of bias. A funnel chart will be used to identify publication or other reporting biases, and the AHRQ guidelines will be used to assess the risk of bias in each included study. The I(2) statistic will be used to assess heterogeneity. If there is a high degree of heterogeneity between the studies, the random effects model will be used; otherwise, a fixed effects model will be used. RESULTS: The results of this systematic review will be published in a peer-reviewed journal. CONCLUSION: This systematic review will evaluate the clinical development of patients with conservatively monitored histologically confirmed HPV16/18+ CIN2.