Detection of in situ and invasive endocervical adenocarcinoma on ThinPrep Pap Test: Morphologic analysis of false negative cases

Background: The goal of this study was to calculate the sensitivity and false negative (FN) rate of ThinPrep Pap Test (TPPT) and carefully analyze missed cases for educational purposes. Materials and Methods: Patients with histologically proven adenocarcinoma in-situ (AIS) or invasive endocervical adenocarcinoma (EAC) over a 17-year-period (1998-2015) were identified. The TPPT immediately preceding the histological diagnosis of AIS/ECA was designated as index Pap (IP). Paps up to 122 months before histologic diagnosis of AIS/ECA were considered for this study. All available negative and unsatisfactory TPPT were re-reviewed. Results: There were 78 patients with histologically-proven AIS (56) or ECA (22) with 184 TPPTs, and 95 of these TPPTs were abnormal. Of the abnormal cases, 55.7% TPPTs were diagnosed as endocervical cell abnormality (atypical endocervical cells/AIS/ECA). Notably, 44.2% of abnormal TPPTs were diagnosed as squamous cell abnormality (atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion/high grade squamous intraepithelial lesion). Including the diagnoses of squamous cell abnormality, the sensitivity of index TPPT for histologically-confirmed AIS/ECA was 88%. Eighty-eight of 184 TPPT, including 10 IP, were negative = 87, or unsatisfactory = 1. Forty-two of these slides were available for re-review. Upon review, 21 TPPT (50%) were confirmed negative and 21 TPPT (50%) were reclassified as abnormal = 20, or unsatisfactory = 1. Of the FN cases, the main difficulty in correct diagnosis was the presence of few diagnostic cell clusters which had less feathering, and consisted of smaller, rounder cells in small and tighter clusters, with nuclear overlap. In particular, nuclear overlap in three-dimensional groups precluded the accurate diagnosis. Rare FN cases showed squamous cell abnormality on re-review, and rare cases showed obscuring blood or inflammation. Conclusion: A significant proportion of AIS/EAC is discovered after Pap showing squamous cell abnormality. FN cases were most commonly related to nuclear overlap in tight three-dimensional clusters.

Download Full-text

Detection of Adenocarcinoma In Situ of the Cervix in Papanicolaou Tests: Comparison of Diagnostic Accuracy With Other High-Grade Lesions

Archives of Pathology & Laboratory Medicine ◽

10.5858/2004-128-153-doaiso ◽

2004 ◽

Vol 128 (2) ◽

pp. 153-157 ◽

Cited By ~ 5

Author(s):

Andrew A. Renshaw ◽

Dina R. Mody ◽

Richard L. Lozano ◽

Emily E. Volk ◽

Molly K. Walsh ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Cell Carcinoma ◽

Squamous Cell ◽

Interlaboratory Comparison ◽

False Negative ◽

Adenocarcinoma In Situ ◽

High Grade ◽

Squamous Intraepithelial Lesion ◽

Intraepithelial Lesion

Abstract Context.—Adenocarcinoma in situ of the cervix is a recently recognized interpretation in the Bethesda 2001 system. Although specific morphologic criteria have been published, recognizing this entity is still difficult. Objective.—To compare pathologists' ability to correctly identify and categorize adenocarcinoma in situ with their ability to identify and categorize adenocarcinoma, high-grade squamous intraepithelial lesion, and squamous cell carcinoma. Design.—Pathologists' reviews in the 2001 and 2002 College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology Program, an interlaboratory comparison program for gynecologic cytology, were examined. Cases were usually reviewed by multiple pathologists. False-negative rates, the percentage of reviews with exact agreement with reference interpretations, and the percentage of cases in which all reviews were in exact agreement with the reference interpretation for adenocarcinoma in situ, adenocarcinoma, high-grade squamous intraepithelial lesion, and squamous cell carcinoma were compared. Results.—A total of 213 reviews of cases categorized as adenocarcinoma in situ were compared with 2821 reviews of adenocarcinoma, 7535 reviews of high-grade squamous intraepithelial lesion, and 1886 reviews of squamous cell carcinoma. The false-negative rate for adenocarcinoma in situ (11.7%) was significantly higher than that for high-grade squamous intraepithelial lesion (4.6%, P < .001) and squamous cell carcinoma (3.3%, P < .001) but not for adenocarcinoma (8.9%, P = .16). Of all the reviews of adenocarcinoma in situ cases, 46.5% were interpreted specifically as adenocarcinoma in situ, compared to 72.2% of reviews of adenocarcinoma, 73.2% of high-grade squamous intraepithelial lesion, and 75.1% of squamous cell carcinoma. No individual case of adenocarcinoma in situ was always specifically recognized as adenocarcinoma in situ; 26.5% of cases of adenocarcinoma were specifically recognized as such in all reviews. Findings were similar with and without the inclusion of high-grade squamous intraepithelial lesion/carcinoma, not otherwise specified, as an acceptable review interpretation for cases of adenocarcinoma, squamous cell carcinoma, and high-grade squamous intraepithelial lesion. Conclusion.—These data from expert-referenced and biopsy-proven cases suggest that adenocarcinoma in situ is not as easily recognized or categorized as other serious diagnoses.

Download Full-text

p16 is superior to Stathmin-1 and HSP27 in identifying cervical dysplasia

Diagnostic Pathology ◽

10.1186/s13000-021-01144-w ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Sofia Liou ◽

Neshat Nilforoushan ◽

Yuna Kang ◽

Neda A. Moatamed

Keyword(s):

Endometrial Adenocarcinoma ◽

Low Grade ◽

Adenocarcinoma In Situ ◽

High Grade ◽

Cervical Tissue ◽

Squamous Intraepithelial Lesion ◽

Endocervical Adenocarcinoma ◽

Stathmin 1 ◽

Intraepithelial Lesion

Abstract Background The aim of this study was to determine how Stathmin-1 and Heat Shock Protein 27 (HSP27) can be used as adjunctive biomarkers to differentiate high-grade dysplasia from benign/reactive lesions in cervical tissues. In addition, we aimed to see if any of these markers can differentiate endometrial from endocervical adenocarcinomas. Methods Fifty cases including benign cervical tissue, low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ of the endocervix, invasive endocervical adenocarcinoma, and endometrial adenocarcinoma were selected. Stathmin-1 and HSP27 immunohistochemistry (IHC) were performed for each case and the results were compared to the previously available p16 IHC stains. Results p16 stained positively in 100% of HSIL, endocervical adenocarcinoma in situ, and invasive endocervical cases. Stathmin-1 stained positively in 43% of HSIL and 90% of endocervical adenocarcinoma in situ and all invasive endocervical cases. Stathmin-1 and p16 were negative in all benign cervical samples. Stathmin-1, HSP27, and p16 stained 100% of LSIL cases. HSP27 stained indiscriminately, including 100% of benign cervical tissue. 87% of the endometrial adenocarcinomas stained positively for p16, Stathmin-1, and HSP27. Conclusion p16 remains superior to both Stathmin-1 and HSP27 in differentiating dysplasia from benign, reactive changes of the cervix.

Download Full-text

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

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2018-0003-cp ◽

2018 ◽

Vol 143 (1) ◽

pp. 81-85 ◽

Cited By ~ 2

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.

Download Full-text

Clinical study on primary screening of oral cancer and precancerous lesions by oral cytology

Diagnostic Pathology ◽

10.1186/s13000-020-01027-6 ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Shintaro Sukegawa ◽

Sawako Ono ◽

Keisuke Nakano ◽

Kiyofumi Takabatake ◽

Hotaka Kawai ◽

...

Keyword(s):

False Positive ◽

Precancerous Lesions ◽

False Positive Rate ◽

False Negative ◽

False Negative Rate ◽

Clinical Findings ◽

Low Grade ◽

Severe Dysplasia ◽

Squamous Intraepithelial Lesion ◽

Intraepithelial Lesion

Abstract Background This study was conducted to compare the histological diagnostic accuracy of conventional oral-based cytology and liquid-based cytology (LBC) methods. Methods Histological diagnoses of 251 cases were classified as negative (no malignancy lesion, inflammation, or mild/moderate dysplasia) and positive [severe dysplasia/carcinoma in situ (CIS) and squamous cell carcinoma (SCC)]. Cytological diagnoses were classified as negative for intraepithelial lesion or malignancy (NILM), oral low-grade squamous intraepithelial lesion (OLSIL), oral high-grade squamous intraepithelial lesion (OHSIL), or SCC. Cytological diagnostic results were compared with histology results. Results Of NILM cytology cases, the most frequent case was negative [LBC n = 50 (90.9%), conventional n = 22 (95.7%)]. Among OLSIL cytodiagnoses, the most common was negative (LBC n = 34; 75.6%, conventional n = 14; 70.0%). Among OHSIL cytodiagnoses (LBC n = 51, conventional n = 23), SCC was the most frequent (LBC n = 31; 60.8%, conventional n = 7; 30.4%). Negative cases were common (LBC n = 13; 25.5%, conventional n = 14; 60.9%). Among SCC cytodiagnoses SCC was the most common (LBC n = 16; 88.9%, conventional n = 14; 87.5%). Regarding the diagnostic results of cytology, assuming OHSIL and SCC as cytologically positive, the LBC method/conventional method showed a sensitivity of 79.4%/76.7%, specificity of 85.1%/69.2%, false-positive rate of 14.9%/30.7%, and false-negative rate of 20.6%/23.3%. Conclusions LBC method was superior to conventional cytodiagnosis methods. It was especially superior for OLSIL and OHSIL. Because of the false-positive and false-negative cytodiagnoses, it is necessary to make a comprehensive diagnosis considering the clinical findings.

Download Full-text

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

Journal of the National Comprehensive Cancer Network ◽

10.6004/jnccn.2004.0050 ◽

2004 ◽

Vol 2 (6) ◽

pp. 597-611 ◽

Cited By ~ 20

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.

Download Full-text

Clinical study on primary screening of oral cancer and precancerous lesions by oral cytology

10.21203/rs.3.rs-34875/v2 ◽

2020 ◽

Author(s):

Shintaro Sukegawa ◽

Sawako Ono ◽

Keisuke Nakano ◽

Kiyofumi Takabatake ◽

Hotaka Kawai ◽

...

Keyword(s):

False Positive ◽

Precancerous Lesions ◽

False Positive Rate ◽

False Negative ◽

False Negative Rate ◽

Clinical Findings ◽

Low Grade ◽

Severe Dysplasia ◽

Squamous Intraepithelial Lesion ◽

Intraepithelial Lesion

Abstract BackgroundThis study was conducted to compare the histological diagnostic accuracy of conventional oral-based cytology and liquid-based cytology (LBC) methods.MethodsHistological diagnoses of 251 cases were classified as negative (no malignancy lesion, inflammation, or mild/moderate dysplasia) and positive [severe dysplasia/carcinoma in situ (CIS) and squamous cell carcinoma (SCC)]. Cytological diagnoses were classified as negative for intraepithelial lesion or malignancy (NILM), oral low-grade squamous intraepithelial lesion (OLSIL), oral high-grade squamous intraepithelial lesion (OHSIL), or SCC. Cytological diagnostic results were compared with histology results.ResultsOf NILM cytology cases, the most frequent case was negative [LBC n = 50 (90.9%), conventional n = 22 (95.7%)]. Among OLSIL cytodiagnoses, the most common was negative (LBC n = 34; 75.6%, conventional n = 14; 70.0%). Among OHSIL cytodiagnoses (LBC n = 51, conventional n = 23), SCC was the most frequent (LBC n = 31; 60.8%, conventional n = 7; 30.4%). Negative cases were common (LBC n = 13; 25.5%, conventional n = 14; 60.9%). Among SCC cytodiagnoses SCC was the most common (LBC n = 16; 88.9%, conventional n = 14; 87.5%). Regarding the diagnostic results of cytology, assuming OHSIL and SCC as cytologically positive, the LBC method/conventional method showed a sensitivity of 79.4%/76.7%, specificity of 85.1%/69.2%, false-positive rate of 14.9%/30.7%, and false-negative rate of 20.6%/23.3%.ConclusionsLBC method was superior to conventional cytodiagnosis methods. It was especially superior for OLSIL and OHSIL. Because of the false-positive and false-negative cytodiagnoses, it is necessary to make a comprehensive diagnosis considering the clinical findings.

Download Full-text

Clinical study on primary screening of oral cancer and precancerous lesions by oral cytology

10.21203/rs.3.rs-34875/v1 ◽

2020 ◽

Author(s):

Shintaro Sukegawa ◽

Sawako Ono ◽

Keisuke Nakano ◽

Kiyofumi Takabatake ◽

Hotaka Kawai ◽

...

Keyword(s):

Conventional Method ◽

False Positive ◽

Precancerous Lesions ◽

False Positive Rate ◽

False Negative ◽

False Negative Rate ◽

Intraepithelial Neoplasia ◽

Low Grade ◽

Squamous Intraepithelial Lesion ◽

Intraepithelial Lesion

Abstract Background This study was conducted to compare histological diagnostic accuracy between conventional method and liquid-based cytology (LBC) method and to clarify the effectiveness of cytology. Methods Histological diagnoses of 251 cases were classified as negative (no malignancy lesion, inflammation, and mild/moderate dysplasia) and positive [oral intraepithelial neoplasia/carcinoma in situ (OIN/CIS) and squamous cell carcinoma (SCC)]. Cytological diagnoses were classified as negative for intraepithelial lesion or malignancy (NILM), oral low-grade squamous intraepithelial lesion (OLSIL), oral high-grade squamous intraepithelial lesion (OHSIL), or SCC. Cytological diagnostic results were compared with histology results. Results Of NILM cytology cases, the most frequent case was negative [LBC n = 50 (90.9%), conventional n = 22 (95.7%)]. Among OLSIL cytodiagnoses, the most common was negative (LBC n = 34; 75.6%, conventional n = 14; 70.0%). Among OHSIL cytodiagnoses (LBC n = 51, conventional n = 23), SCC was the most frequent (LBC n = 31; 60.8%, conventional n = 7; 30.4%). Negative cases were common (LBC n = 13; 25.5%, conventional n = 14; 60.9%). Among SCC cytodiagnoses SCC was the most common (LBC n = 16; 88.9%, conventional n = 14; 87.5%). Regarding the diagnostic results of cytology, assuming HSIL and SCC as cytologically positive, the LBC method/conventional method showed a sensitivity of 79.4%/76.7%, specificity of 85.1%/69.2%, false positive rate of 14.9%/30.7%, and false negative rate of 20.6%/23.3%. Conclusions LBC method was superior to conventional method in cytodiagnosis. It was especially superior for LSIL and HSIL. Because of the false positive and false negative cytodiagnoses, it is necessary to make a comprehensive diagnosis considering the clinical findings.

Download Full-text

Evaluation of the In Situ Hybridization Signal Patterns of Liquid-Based Cytological Human Papillomavirus Specimens for Diagnosing Squamous Intraepithelial Lesion

ISRN Pathology ◽

10.5402/2011/219790 ◽

2011 ◽

Vol 2011 ◽

pp. 1-9

Author(s):

Katsunari Ishida ◽

Makoto Nagasaki ◽

Masayuki Kobayashi ◽

Tatsushi Nakagawa ◽

Toru Nabika ◽

...

Keyword(s):

Human Papillomavirus ◽

Low Grade ◽

Squamous Intraepithelial Lesion ◽

Routine Testing ◽

Squamous Cells ◽

Intraepithelial Lesion ◽

Liquid Based Cytology ◽

Undetermined Significance

To examine the diagnostic utility for squamous intraepithelial lesion (SIL) by cytological in situ hybridization (c-ISH) for the human papillomavirus using liquid-based cytology specimens, we investigated c-ISH signal patterns in the cases of low-grade SIL (LSIL), atypical squamous cells of undetermined significance (ASC-US), and high-grade SIL (HSIL). Episomal (E) and/or integrated (I) signals were observed. Two signal patterns (E≧I or I>E) were obtained by counting the number of E+ or I+ cells. E≧I was specific to LSIL and ASC-US (10/12); I>E, to HSIL (9/11) (P<0.01, χ2 test), suggesting significant utility of c-ISH in diagnosing SIL. In the cell fraction, E≧I in large cells was dominant in LSIL. Two cases of I>E in large cells of LSIL showed HPV persistence and/or progression during follow-up. Thus, c-ISH is useful in routine testing for diagnosing cervical dysplastic lesions, especially for detecting LSIL suspected for progression.

Download Full-text

Comparison of Performance of Conventional and ThinPrep Gynecologic Preparations in the College of American Pathologists Gynecologic Cytology Program

Archives of Pathology & Laboratory Medicine ◽

10.5858/2004-128-17-copoca ◽

2004 ◽

Vol 128 (1) ◽

pp. 17-22 ◽

Cited By ~ 8

Author(s):

Andrew A. Renshaw ◽

Nancy A. Young ◽

George G. Birdsong ◽

Patricia E. Styer ◽

Diane D. Davey ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Cell Carcinoma ◽

Squamous Cell ◽

Error Rate ◽

False Negative ◽

Error Rates ◽

High Grade ◽

Squamous Intraepithelial Lesion ◽

Exact Match ◽

Intraepithelial Lesion

Abstract Context.—Results of clinical trials suggest that interpretation of liquid-based cytology preparations is more accurate and is associated with less screening error than interpretation of conventional preparations. Objective.—In this study, the performance of participants in interpreting ThinPrep (TP) preparations was compared with participants' performance on conventional Papanicolaou tests in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology (PAP). Design.—The results of the PAP from the year 2002 were reviewed, and the discordancies to series and exact-match error rates for the 2 cytologic methods were compared. Results.—For this study, a total of 89 815 interpretations from conventional smears and 20 886 interpretations from TP samples were analyzed. Overall, interpretations of TP preparations had both significantly fewer false-positive (1.6%) and false-negative (1.3%) rates than those of conventional smears (P = .001 and P = .02, respectively) for validated or validated-equivalent slides, as assessed by concordance with the correct diagnostic series. In this assessment of concordance to series, interpretations of educational TP and conventional preparations were similar, except for high-grade squamous intraepithelial lesion, in which the performance was significantly worse for educational TP preparations (false-negative rate of 8.1% vs 4.1% for conventional smears, P < .001). When interpretations were matched to the exact diagnosis, validated-equivalent TP preparations were generally more accurate for diagnoses in the 100 series and 200 series than were conventional smears. Notably, for the reference diagnosis of squamous cell carcinoma, the exact-match error rate on validated equivalent TP slides was significantly greater than that of conventional slides (44.5% vs 23.1%, P < .001). Interpretations of educational TP preparations also had a significantly higher error rate in matching to the exact reference diagnosis for squamous cell carcinoma (33.7% vs 22.8%, P = .007). Conclusions.—Overall, TP preparations in this program were associated with significantly lower error rates than conventional smears for both validated and educational cases. However, unlike the negative for intraepithelial lesion and malignancy, not otherwise specified, low-grade squamous intraepithelial lesion, and adenocarcinoma cytodiagnostic challenges, participants' responses indicated some difficulty in recognizing high-grade squamous intraepithelial lesion and squamous cell carcinoma.

Download Full-text

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

Archives of Pathology & Laboratory Medicine ◽

10.5858/2003-127-1169-ahptit ◽

2003 ◽

Vol 127 (9) ◽

pp. 1169-1175 ◽

Cited By ~ 2

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.

Download Full-text