A randomized trial comparing conventional cytology to liquid‐based cytology and computer assistance

Abstract

Liquid-based cytology (LBC) has replaced conventional cytology (CC) for cervical cancer screening in some countries. However, it remains unclear whether LBC is superior to CC. A randomized controlled trial was conducted between August 2007 and March 2009 in Germany to compare LBC, alone and in combination with computer-assisted imaging technology (CAS), to CC in the detection of histologically confirmed cervical intraepithelial neoplasia (CIN). The main outcome measures were detection rates, relative sensitivities, positive predictive values (PPVs) and relative PPVs comparing LBC without and with CAS to CC. Primary histological outcome was CIN2 or higher. Included were 20,627 women participating in opportunistic cervical cancer screening at 20 gynecologic practices. The practices were randomized weekly to use LBC (n 5 11,331) or CC (n 5 9,296). Patients with positive findings were invited to expert colposcopy. The relative sensitivity of LBC versus CC using the CIN21 cut-off was 2.74 (95% confidence interval [CI] 1.66-4.53). The relative sensitivity of LBC/CAS versus CC for CIN21 was 3.17 (95% CI 1. 94-5.19). The PPV of LBC and CC for CIN21 was 48% and 38%, respectively. The PPV ratio did not differ significantly from unity. Differences between LBC and CC were smaller in some sensitivity and subgroup analyses; however, relative sensitivity of LBC remained increased. LBC without and with CAS compared with CC under the field conditions of an opportunistic screening system had a significantly higher sensitivity for the detection of CIN without deterioration of PPVs. Additional use of CAS did not further improve sensitivity of LBC. V C 2012 Wiley Periodicals, Inc.Key words: randomized controlled trial, early detection of cancer, uterine cervical neoplasm, Papanicolaou smear, liquid-based cytology, computer-assisted imaging technology Additional Supporting Information may be found in the online version of this article. Stefanie J. Klug, Jochem K€ onig and Hans Ikenberg had full access to all the data of the study. They take responsibility for the integrity of the data and the accuracy of the data analysis. Hans Ikenberg, Stefanie J. Klug, Klaus J. Neis and Werner Harlfinger take responsibility for the study concept and design. Werner Harlfinger and Klaus J. Neis take responsibility for the acquisition of data. Stefanie J. Klug, Jochem K€ onig, Veronika Weyer and Hans Ikenberg take responsibility for the analysis and interpretation of data. Stefanie J. Klug and Hans Ikenberg take responsibility for the drafting of the manuscript. All are responsible for the critical revision of the manuscript for important intellectual content. Jochem K€ onig, Veronika Weyer and Stefanie J. Klug did the statistical analysis. Werner Harlfinger, Klaus J. Neis, Armin Malter and Hans Ikenberg obtained funding. Sibylle Spieth, Friederike Brinkmann-Smetanay and Friedrich Kommoss had the administrative, technical or material support. Study supervision is by Hans Ikenberg, Werner Harlfinger, Klaus J. Neis and Stefanie J. Klug. Stefanie J. Klu...

Cervical cancer incidence after normal cytological sample in routine screening using SurePath, ThinPrep, and conventional cytology: population based study

“…Moreover, multiple studies have shown that CIN II + detection was unaffected or slightly decreased by adding automated assisted reading to ThinPrep or SurePath. [32][33][34] Secondly, as we did not have a unique identification code (the identification code was based on the first eight letters of the (maiden) family name and birth date), tests belonging to different women may have been allocated to a single woman (so-called fusions). However, we think it unlikely that these fusions would be correlated with the type of cytology test used.…”

HPV vaccine impact in Australian women: ready for an HPV‐based screening program

“…Since there is no local data available to inform the unsatisfactory rate of manually-read LBC in Australia, we used 1.8 per cent as the base case unsatisfactory rate for manually-read LBC, based on the image-read LBC unsatisfactory rate observed in an Australian study (Davey et al 2007a) (Table 87). The range selected for sensitivity analyses was based on the lowest (0.31%) (Klug et al 2013) and the highest rate (2.57%) (Ronco et al 2007) observed among international randomised controlled trials included in the review of evidence for the National Cervical Screening Program Renewal (MSAC 2013). Image-read LBC…”

<p>Cost-Effectiveness and Cost-Benefit of Cervical Cancer Screening with Liquid Based Cytology Compared with Conventional Cytology in Germany</p>

“…10 There are multiple screening techniques including conventional cytology (CC) and liquid based cytology (LBC). 2 CC, also called the Papanicolaou or Pap test has been around for over 50 years and has been the standard screening technique in Germany since screening began in the 1970s. 2,11,12 The test involves a sample of cells being taken from the cervix and smeared directly onto a glass slide.…”

“…2 CC, also called the Papanicolaou or Pap test has been around for over 50 years and has been the standard screening technique in Germany since screening began in the 1970s. 2,11,12 The test involves a sample of cells being taken from the cervix and smeared directly onto a glass slide. 13 Since then, LBC has been introduced in a number of developed countries, such as New Zealand, the United Kingdom and the United States of America.…”