Immediate referral to colposcopy versus cytological surveillance for minor cervical cytological abnormalities in the absence of HPV test

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Title: Immediate referral to colposcopy versus cytological surveillance for minor cervical cytological abnormalities in the absence of HPV test
Authors: Kyrgiou, M
Kalliala, I
Mitra, A
Fotopoulou, C
Ghaem-maghami, S
Martin-Hirsch, P
Cruickshank, M
Arbyn, M
Paraskevaidis, E
Item Type: Journal Article
Abstract: Background A significant number of women are diagnosed with minor cytologi cal abnormalities on cervical screening. Many authorities recom mend surveillance as spontaneous regression might occur. However, attendance for cytological follow-up decreases with time and mig ht put some women at risk of developing invasive disease. Objectives To assess the optimum management strategy for women with min or cervical cytological abnormalities (atypical squamous cells of undetermined significance - ASCUS or low-grade squamous intra-e pithelial lesions - LSIL) at primary screening in the absence o f HPV (human papillomavirus) DNA test. Search methods We searched the following electronic databases: Cochrane Cent ral Register of Controlled Trials (CENTRAL Issue 4 2016), MEDL INE, and Embase from inception to 21 April 2016. Selection criteria We included randomised controlled trials (RCTs) comparing imme diate colposcopy to cytological surveillance in women with atyp- ical squamous cells of undetermined significance (ASCUS/borderl ine) or low-grade squamous intra-epithelial lesions (LSIL/mi ld dyskaryosis). Data collection and analysis The primary outcome measure studied was the occurrence of cervical intra-epithelial neoplasia (CIN). The secondary outcome measur es studied included default rate, clinically significant anxiety a nd depression, and other self-reported adverse effects. We classified studies according to period of surveillance, at 6, 1 2, 24 or 36 months, as well as at 18 months, excluding a possible exit-examination. We calculated pooled risk ratios (RR) and 95% confidence intervals (CI) using a random-effects model with inver se variance weighting. Inter-study heterogeneity was assessed with I 2 statistics. Main results We identified five RCTs with 11,466 participants that fulfilled the inclusion criteria. There were 18 cases of invasive cervical ca ncer, seven in the immediate colposcopy and 11 in the cytological surve illance groups, respectively. Although immediate colposcopy d etects CIN2+ and CIN3+ earlier than cytology, the differences were no longer observed at 24 months (CIN2+: 3 studies, 4331 women; 17.9% versus 18.3%, RR 1.14, CI 0.66 to 1.97; CIN3+: 3 studies , 4331 women; 10.3% versus 11.9%, RR 1.02, CI 0.53 to 1.97). The inter-study heterogeneity was considerable (I 2 greater than 90%). Furthermore, the inclusion of the results o f the exit examinations at 24 months, which could inflate the CIN detection rate of cytolog ical surveillance, may have led to study design-derived bias; w e therefore considered the evidence to be of low quality. When we excluded the exit examination, the detection rate of hig h-grade lesions at the 18-month follow-up was higher after imme diate colposcopy (CIN2+: 2 studies, 4028 women; 14.3% versus 10.1%, R R 1.50, CI 1.12 to 2.01; CIN3+: 2 studies, 4028 women, 7.8% versus 6.9%, RR 1.24, CI 0.77 to 1.98) both had substantial in ter-study heterogeneity (I 2 greater than 60%) and we considered the evidence to be of moderate quality). The meta-analysis revealed that immediate referral to colpos copy significantly increased the detection of clinically insignifi cant cervical abnormalities, as opposed to repeat cytology after 24 months of surveillance (presence of koilocytosis: 2 studies, 656 women ; 32% versus 21%, RR 1.49, 95% CI 1.17 to 1.90; moderate-quality evi dence); incidence of any CIN: 2 studies, 656 women; 64% versus 32%, RR 2.02, 95% CI 1.33 to 3.08, low-quality evidence; inciden ce of CIN1: 2 studies, 656 women; 21% versus 8%, RR 2.58, 95% CI 1.69 to 3.94, moderate-quality evidence). Due to differences in trial designs and settings, there was la rge variation in default rates between the included studies. The risk for default was higher for the repeat cytology group, with a four-f old increase at 6 months, a six-fold at 12 and a 19-fold at 24 month s (6 months: 3 studies, 5117 women; 6.3% versus 13.3%, RR 3.85, 9 5% CI 1.27 to 11.63, moderate-quality evidence; 12 months: 3 studies, 5115 women; 6.3% versus 14.8%, RR 6.39, 95% CI 1.24 t o 32.95, moderate-quality evidence; 24 months: 3 studies, 433 1 women; 0.9% versus 16.1%, RR 19.1, 95% CI 9.02 to 40.43, moder ate-quality evidence). Authors’ conclusions Based on low- or moderate-quality evidence using the GRADE app roach and generally low risk of bias, the detection rate of CIN2 + or CIN3+ after two years does not appear to differ between imm ediate colposcopy and cytological surveillance in the absence of H PV testing, although women may default from follow-up. Immedia te colposcopy probably leads to earlier detection of high-grade lesions, but also detects more clinically insignificant low-grade lesions . Colposcopy may therefore be the first choice when good compliance is not assured. These results emphasize the need for an accurate r eflex HPV triage test to distinguish women who need diagnosti c follow- up from those who can return safely to routine recall.
Issue Date: 26-Jan-2017
Date of Acceptance: 5-Dec-2016
ISSN: 1469-493X
Publisher: Cochrane Collaboration
Journal / Book Title: Cochrane Database of Systematic Reviews
Volume: 1
Issue: 1
Copyright Statement: © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Sponsor/Funder: British Society for Colposcopy and Cervical Pathology
Imperial College Healthcare Charity
Imperial College Healthcare NHS Trust- BRC Funding
Genesis Research Trust
Sigrid Juselius Foundation
Imperial College Healthcare Charity
Funder's Grant Number: N/A
RDB01 79560
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
Cervical Intraepithelial Neoplasia
Patient Compliance
Precancerous Conditions
Randomized Controlled Trials as Topic
Referral and Consultation
Time Factors
Vaginal Smears
Watchful Waiting
11 Medical And Health Sciences
Publication Status: Published
Article Number: CD009836
Appears in Collections:Division of Surgery
Division of Cancer
Faculty of Medicine

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