Liquid-Based Cytology: Evaluation of Effectiveness, Cost-Effectiveness, and Application to Present Practice

2004 ◽  
Vol 2 (6) ◽  
pp. 597-611 ◽  
Author(s):  
J. Thomas Cox
Keyword(s):  
Cost Effectiveness ◽  
Cervical Screening ◽  
Pap Test ◽  
Representative Specimen ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Split Sample ◽  
Intraepithelial Lesion ◽  
Liquid Based Cytology

This article reviews the data available as of 2004 on the effectiveness and cost-effectiveness of cervical screening with the two available cytologic methods, the conventional Papanicolaou (Pap; CP) smear and liquid-based cytology (LBC), and discusses the application of LBC to current practice. The majority of LBC studies are on the ThinPrep Pap Test (CYTYC, Boxsborough, MA) and the remainder are on SurePath (TriPath, Burlington, NC), which was previously known as AutoCyte Prep. LBC identified more low-grade squamous intraepithelial lesion (LSIL) Pap test results compared with paired conventional cytology in 17 of 21 ThinPrep and 9 of 12 SurePath “split-sample” studies considered to fulfill the criteria for inclusion in the British NHS Health Technology Assessment (HTA) evaluation of cervical cytology. In four of the six recent ThinPrep and one of two SurePath split-sample studies, more high-grade squamous intraepithelial lesion-positive (HSIL+) results were identified by LBC than by CP. All 15 “direct-to vial studies” meeting HTA criteria reported more LSIL+ results for LBC compared with CP, and all eight of the direct-to-vial studies reporting HSIL+ results separately showed increased detection of high-grade cytology interpretations. Fifteen studies met the criteria for evaluating sensitivity and specificity. Aggregate sensitivity for the CP was 71.5% and for LBC was 80.1%. Indirect comparisons of the two LBC methods did not detect a difference in sensitivity, and a meta-analysis of the six studies comparing specificity between CP and LBC found no difference. Other capabilities of LBC are improved specimen adequacy and the ability to do ancillary testing out of the liquid-based vial. In cost-effective analyses based on models of disease natural history and/or the clinical effectiveness of each screening modality, screening with CP was always dominated by screening with LBC. Primary cervical screening guidelines issued by the American Cancer Society in 2002 recommend repeating the cytology biannually if liquid-based and annually if conventional. The gain in sensitivity, apparent cost-effectiveness, and advantage of having a representative specimen for ancillary testing, support the use of LBC.

Adjunctive Human Papillomavirus Testing in the 2-Year Follow-up of Women With Low-Grade Cervical Cytologic Abnormalities: A Randomized Trial and Economic Evaluation

2003 ◽  
Vol 127 (9) ◽  
pp. 1169-1175 ◽  
Author(s):  
Alice Lytwyn ◽  
John W. Sellors ◽  
James B. Mahony ◽  
Dean Daya ◽  
William Chapman ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Cervical Intraepithelial Neoplasia ◽  
Pap Test ◽  
Intraepithelial Neoplasia ◽  
Low Grade ◽  
High Grade ◽  
Hpv Testing ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion

Abstract Context.—Although human papillomavirus (HPV) testing may aid in managing low-grade abnormality on screening cervical cytology, patient compliance with repeat testing programs requires consideration. Objectives.—To determine effectiveness and costs of repeated Papanicolaou (Pap) test and oncogenic HPV testing for detecting cervical intraepithelial neoplasia 2 or 3. Design.—We conducted a randomized controlled trial of combined Pap test and cervical HPV testing by Hybrid Capture 1 test compared with Pap test alone; tests were performed every 6 months for up to 2 years. The study end point was colposcopic examination performed on all women at 2 years, or earlier if an HPV test was positive or if a Pap test showed high-grade squamous intraepithelial lesion. Setting.—Sixty-six community family practices. Participants.—Two hundred fifty-seven women with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion on screening cervical cytology. Main Outcome Measures.—Detection of histologically confirmed cervical intraepithelial neoplasia 2 or 3, fully allocated costs, and loss to follow-up. Results.—Combined Pap test and HPV testing detected 11 (100%) of 11 cases of cervical intraepithelial neoplasia 2/3, whereas Pap test alone detected 7 (63.6%) of these 11 cases (P = .14); corresponding specificities were 39 (46.4%) of 84 and 45 (71.4%) of 63 (P = .005). The cost-effectiveness ratio was Can $4456 per additional case of high-grade cervical intraepithelial neoplasia. Sixty-nine (26.8%) of the 257 women (24.6% combined group vs 29.1% Pap test only group, P = .41) defaulted from testing or from colposcopy when referred with an abnormal result. Conclusions.—Combined testing was more costly but may detect more cases of cervical intraepithelial neoplasia 2/3 than Pap test alone. However, poor adherence limits usefulness of a management strategy that requires repeated follow-up.

Cytologic Features of Low-Grade Squamous Intraepithelial Lesion in ThinPrep Papanicolaou Test Slides and Conventional Smears: Comparison of Cases That Performed Poorly With Those That Performed Well in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology

2005 ◽  
Vol 129 (1) ◽  
pp. 23-25 ◽  
Author(s):  
Andrew A. Renshaw ◽  
Barbara Dubray-Benstein ◽  
Jennifer Haja ◽  
Jonathan H. Hughes
Keyword(s):  
Interlaboratory Comparison ◽  
Pap Test ◽  
Median Number ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Papanicolaou Test ◽  
Abnormal Cells ◽  
Intraepithelial Lesion ◽  
Intraepithelial Lesions

Abstract Context.—Both conventional and ThinPrep Papanicolaou smears with high-grade squamous intraepithelial lesions that are frequently missed are known to have relatively few abnormal cells. Whether this is also true of cases of low-grade squamous intraepithelial lesion is not known. Objective.—To compare the cytologic features of cases of low-grade squamous intraepithelial lesion that perform poorly with the features of cases that perform well. Design.—The cytologic features of 10 ThinPrep Pap Test and conventional smear cases of low-grade squamous intraepithelial lesion that performed poorly in the College of American Pathologists Interlaboratory Comparison Program were compared with 46 ThinPrep Pap Test and conventional smear cases that performed extremely well. The numbers of abnormal cells were categorized into less than 50, 51 to 100, 101 to 250, 251 to 500, and more than 500. Results.—The median number of abnormal cells for cases that performed poorly was less than 50, whereas the median number of abnormal cells for cases that performed well was between 101 and 250. Overall, cases that performed poorly were significantly more likely to have less than 50, less than 100, and less than 250 abnormal cells than cases that performed well (P < .001, P < .001, and P = .009, respectively). A minority of cases performed well even with very few abnormal cells and groups. The same findings were present when conventional smears and ThinPrep specimens were analyzed separately. Conclusions.—ThinPrep Pap Test cases and conventional smears with a diagnosis of low-grade squamous intraepithelial lesion that perform poorly in this program have significantly fewer abnormal cells than those that perform well. The median number of abnormal cells in cases that performed well is lower than that of comparable high-grade cases in the program.

scholarly journals Trends in Cervical Cytology Screening and Reporting Practices: Results From the College of American Pathologists 2011 PAP Education Supplemental Questionnaire

2015 ◽  
Vol 140 (1) ◽  
pp. 13-21 ◽  
Author(s):  
Barbara A. Crothers ◽  
Teresa M. Darragh ◽  
Rosemary H. Tambouret ◽  
Ritu Nayar ◽  
Guliz A. Barkan ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Reporting Practices ◽  
Quality Assurance Measure ◽  
Intraepithelial Lesion ◽  
Liquid Based Cytology

Context The College of American Pathologists periodically surveys laboratories to determine changes in cytopathology practices. We report the results of a 2011 gynecologic cytology survey. Objective To provide a cross-sectional survey of gynecologic cytology practices in 2010. Design In 2011, a survey was sent to 1604 laboratories participating in the College of American Pathologists gynecologic cytology interlaboratory comparison education program and proficiency testing programs requesting data from 2010 on the following topics: terminology/reporting, cytotechnologist workload, quality assurance, reagents, and ancillary testing. Results Six hundred and twenty-five laboratories (39%) replied to the survey. The nonstandard use of “low-grade squamous intraepithelial lesion cannot exclude high-grade squamous intraepithelial lesion” is used by most laboratories to report the presence of low-grade squamous intraepithelial lesion with possibility of high-grade squamous intraepithelial lesion. Most laboratories also report the presence or absence of cells from the transformation zone. Most respondents do not limit cytotechnologist screening workload during the work shift. Only about one-third of laboratories (188 of 582; 32%) use image-assisted screening devices. Rapid prescreening as a quality assurance measure is used by only 3.5% (21 of 594) of the laboratories. When used for screening, most laboratories use the imager for retrospective review of slides to detect human locator and interpretive errors. Most laboratories receive both liquid-based cytology samples (mainly ThinPrep, Hologic, Marlborough, Massachusetts) and conventional Papanicolaou tests. Expiration dates of liquid-based cytology test vials are not usually recorded. Conclusions The field of gynecologic cytology is evolving rapidly. These survey results offer a snapshot of national gynecologic cytology practices in 2010.

scholarly journals Evidence for increasing usage of low-grade squamous intraepithelial lesion, cannot exclude high-grade squamous intraepithelial lesion (LSIL-H) Pap test interpretations

2013 ◽  
Vol 122 (2) ◽  
pp. 123-127 ◽  
Author(s):  
Vighnesh Walavalkar ◽  
Douglas Tommet ◽  
Andrew H. Fischer ◽  
Yuxin Liu ◽  
Debra M. Papa ◽  
...  
Keyword(s):  
Pap Test ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion

Low Utility in Colposcopy-directed Biopsies for Non-high Grade Cytological Abnormalities on PAP Smear

2020 ◽  
Vol 16 (1) ◽  
pp. 18-22
Author(s):  
Eronmwon E. Gbinigie ◽  
Joshua Fogel ◽  
Maggie Tetrokalashvili
Keyword(s):  
Pap Smear ◽  
Multinomial Logistic Regression ◽  
Cervical Dysplasia ◽  
Outcome Variable ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion ◽  
Cytologic Abnormalities ◽  
Cytology Screening

Background: Clinicians commonly perform colposcopy directed biopsies on patients with low grade squamous intraepithelial lesion (LSIL) on PAP cytology even when not consistent with clinical guidelines. Objective: We study the association of PAP cytology screening results with cervical intra-epithelia neoplasia (CIN) 2-3 high-grade dysplasia, as confirmed by colposcopy-directed biopsy. Methods: A retrospective study of 263 women with an abnormality on the PAP smear. Multinomial logistic regression was performed with predictors of PAP cytology screening results with the outcome variable of colposcopy-directed biopsy. Results: High grade squamous intraepithelial lesion (HSIL) had significantly increased relative risk for CIN 2-3 (RR: 9.85, 95% CI: 1.84, 52.79, p=0.008). LSIL was not significantly associated with CIN 2-3. In the comparisons of negative with CIN-1, both HSIL and LSIL were not significantly associated with a negative biopsy. Conclusion: HSIL is associated with cervical dysplasia of CIN 2-3 while LSIL is not associated with cervical dysplasia of CIN 2-3. We do not recommend routine biopsies in patients with LSIL cytologic abnormalities unless additional compelling factors exist.

scholarly journals Low-Grade Squamous Intraepithelial Lesion or High-Grade Squamous Intraepithelial Lesion? Concordance Between the Interpretation of Low-Grade Squamous Intraepithelial Lesion and High-Grade Squamous Intraepithelial Lesion in Papanicolaou Tests: Results From the College of American Pathologists PAP Education Program

2018 ◽  
Vol 143 (1) ◽  
pp. 81-85 ◽  
Author(s):  
Barbara A. Crothers ◽  
Mohiedean Ghofrani ◽  
Chengquan Zhao ◽  
Leslie G. Dodd ◽  
Kelly Goodrich ◽  
...  
Keyword(s):  
Education Program ◽  
Repeated Measures ◽  
False Negative ◽  
Misclassification Rate ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Significant Difference ◽  
Intraepithelial Lesion ◽  
Diagnostic Concordance

Context.— Obtaining diagnostic concordance for squamous intraepithelial lesions in cytology can be challenging. Objective.— To determine diagnostic concordance for biopsy-proven low-grade squamous intraepithelial lesion (LSIL) and high-grade squamous intraepithelial lesion (HSIL) Papanicolaou test slides in the College of American Pathologists PAP Education program. Design.— We analyzed 121 059 responses from 4251 LSIL and HSIL slides for the interval 2004 to 2013 using a nonlinear mixed-model fit for reference diagnosis, preparation type, and participant type. We evaluated interactions between the reference diagnosis and the other 2 factors in addition to a repeated-measures component to adjust for slide-specific performance. Results.— There was a statistically significant difference between misclassification of LSIL (2.4%; 1384 of 57 664) and HSIL (4.4%; 2762 of 63 395). There was no performance difference between pathologists and cytotechnologists for LSIL, but cytotechnologists had a significantly higher HSIL misclassification rate than pathologists (5.5%; 1437 of 27 534 versus 4.0%; 1032 of 25 630; P = .01), and both were more likely to misrepresent HSIL as LSIL (P < .001) than the reverse. ThinPrep LSIL slides were more likely to be misclassified as HSIL (2.4%; 920 of 38 582) than SurePath LSIL slides (1.5%; 198 of 13 196), but conventional slides were the most likely to be misclassified in both categories (4.5%; 266 of 5886 for LSIL, and 6.5%; 573 of 8825 for HSIL). Conclusions.— More participants undercalled HSIL as LSIL (false-negative) than overcalled LSIL as HSIL (false-positive) in the PAP Education program, with conventional slides more likely to be misclassified than ThinPrep or SurePath slides. Pathologists and cytotechnologists classify LSIL equally well, but cytotechnologists are significantly more likely to undercall HSIL as LSIL than are pathologists.

scholarly journals Adenoid Basal Carcinoma of Cervix: A Rare Case Report

2020 ◽  
Vol 3 (2) ◽  
pp. 392-394
Author(s):  
Alina Karna ◽  
Nisha Sharma
Keyword(s):  
Pap Smear ◽  
Total Abdominal Hysterectomy ◽  
Abdominal Hysterectomy ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Adenoid Cystic ◽  
Carcinoma Of Cervix ◽  
Rare Case Report ◽  
Intraepithelial Lesion

Adenoid basal carcinoma of the uterine cervix is a rare low-grade tumor and its cell origin is still obscure. Adenoid basal carcinoma can be confused with adenoid basal hyperplasia, adenoid cystic carcinoma, and basaloid squamous cell carcinoma of the cervix. We present here a case of a 59 year-old-female who initially presented with a high-grade squamous intraepithelial lesion on Pap smear. Total abdominal hysterectomy with bilateral salpingo-oophorectomy was performed. Histopathology revealed focal invasive adenoid basal carcinoma with extensive areas of a high-grade squamous intraepithelial lesion involving the endocervical gland. The immunohistochemical stain was positive for p16.

scholarly journals A multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira®) as a novel treatment in patients with high grade squamous intraepithelial lesion: APRICITY Phase 3 study protocol

2021 ◽  
Author(s):  
Fei Chen ◽  
Zoltán Novák ◽  
Christian Dannecker ◽  
Long Sui ◽  
Youzhong Zhang ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Low Grade ◽  
High Grade ◽  
Efficacy And Safety ◽  
Squamous Intraepithelial Lesion ◽  
Phase 3 ◽  
Link Type ◽  
Surgical Methods ◽  
Intraepithelial Lesion ◽  
Randomised Controlled

AbstractIntroductionHigh-risk human papilloma virus (HPV)-associated cervical cancer is the fourth most common cancer in women worldwide. Current treatments of high grade squamous intraepithelial lesion (HSIL) of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality.ObjectiveAPRICITY is a multicentre, prospective, double-blind, randomised controlled Phase 3 study further evaluating the efficacy and safety of Cevira®, an integrated drug- and light-delivery device for hexaminolevulinate photodynamic therapy, which shows promise as a novel, non-invasive therapy for women with HSIL.Methods and analysisPatients with biopsy-confirmed HSIL histology are invited to participate in the study currently being conducted at 47 sites in China and 25 sites in Ukraine, Russia and European Union. The aim is to include at least 384 patients which will be randomised to either Cevira® or placebo group (2:1). All patients will be assessed 3 months after first treatment and a second treatment will be administered in patients who are HPV positive or have at least low grade squamous intraepithelial lesion (LSIL). Primary endpoint is the proportion of the responders at 6 months after first treatment. Secondary efficacy endpoints and safety endpoints will be assessed at 6 months, and data for secondary performance endpoints for Cevira® device will be collected at 3 months and 6 months, in case second treatment was administered. All patients in the Cevira® group will be enrolled in an open, long-term extension study following patients for further 6 months to collect additional efficacy and safety data (study extension endpoints).ConclusionDue to its non-invasiveness and convenient application, Cevira® may be a favourable alternative to surgical methods in treatment of patients with HSIL.Ethics and disseminationThe study was approved by the ethics committee of the Peking Union Medical College Hospital and Hannover Medical University, Germany. Findings will be disseminated through peer review publications and conference presentations.Trial registration numberclinicaltrials.govNCT04484415

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