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Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study.
PLoS One. 2013; 8(12):e82115.Plos

Abstract

Self-sampling could increase cervical cancer screening uptake. While methods have been identified for human papillomavirus (HPV) testing, to date, self-sampling has not provided adequate specimens for cytology. We piloted the validity and reliability of using a self-lavaging device for cervical cytology and HPV testing. We enrolled 198 women in New York City in 2008-2009 from three ambulatory clinics where they received cervical cancer screening. All were asked to use the Delphi Screener™ to self-lavage 1-3 months after clinician-collected index cytological smear (100 normal; 98 abnormal). Women with abnormal cytology results from either specimen underwent colposcopy; 10 women with normal results from both specimens also underwent colposcopy. We calculated sensitivity of self-collected cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. One hundred and ninety-seven (99.5%) women self-collected a lavage. Seventy-five percent had moderate to excellent cellularity, two specimens were unsatisfactory for cytology. Seven of 167 (4%) women with definitive results had CIN2+; one had normal and six abnormal cytology results with the self-lavage (sensitivity = 86%, 95% Confidence Interval, CI: 42, 100). The kappa for paired cytology was low (0.36; 95% CI: 0.25, 0.47) primarily due to clinician specimens with atypical squamous cells of undetermined significance (ASC-US) and low grade squamous intraepithelial lesion (LSIL) coded as normal using Screener specimens. However, three cases of HSIL were coded as ASC-US and one as normal using Screener specimens. Seventy-three women had paired high-risk HPV tests with a kappa of 0.66 (95% CI: 0.49, 0.84). Based on these preliminary findings, a larger study to estimate the performance of the Screener for co-testing cytology and HPV or for HPV testing with cytology triage is warranted.

TRIAL REGISTRATION

ClinicalTrials.gov NCT00702208.

Authors+Show Affiliations

Department of Obstetrics & Gynecology, Columbia University Medical Center, New York, New York, United States of America ; Epidemiology & Biostatistics Program, City University of New York School of Public Health and Hunter College, New York, New York, United States of America.Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York, United States of America.Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York, United States of America.Department of Obstetrics & Gynecology, Columbia University Medical Center, New York, New York, United States of America.

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

24376516

Citation

Jones, Heidi E., et al. "Validity and Reliability of Using a Self-lavaging Device for Cytology and HPV Testing for Cervical Cancer Screening: Findings From a Pilot Study." PloS One, vol. 8, no. 12, 2013, pp. e82115.
Jones HE, Mansukhani MM, Tong GX, et al. Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study. PLoS ONE. 2013;8(12):e82115.
Jones, H. E., Mansukhani, M. M., Tong, G. X., & Westhoff, C. L. (2013). Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study. PloS One, 8(12), e82115. https://doi.org/10.1371/journal.pone.0082115
Jones HE, et al. Validity and Reliability of Using a Self-lavaging Device for Cytology and HPV Testing for Cervical Cancer Screening: Findings From a Pilot Study. PLoS ONE. 2013;8(12):e82115. PubMed PMID: 24376516.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study. AU - Jones,Heidi E, AU - Mansukhani,Mahesh M, AU - Tong,Guo-Xia, AU - Westhoff,Carolyn L, Y1 - 2013/12/20/ PY - 2013/06/26/received PY - 2013/10/16/accepted PY - 2013/12/31/entrez PY - 2014/1/1/pubmed PY - 2015/3/4/medline SP - e82115 EP - e82115 JF - PloS one JO - PLoS ONE VL - 8 IS - 12 N2 - UNLABELLED: Self-sampling could increase cervical cancer screening uptake. While methods have been identified for human papillomavirus (HPV) testing, to date, self-sampling has not provided adequate specimens for cytology. We piloted the validity and reliability of using a self-lavaging device for cervical cytology and HPV testing. We enrolled 198 women in New York City in 2008-2009 from three ambulatory clinics where they received cervical cancer screening. All were asked to use the Delphi Screener™ to self-lavage 1-3 months after clinician-collected index cytological smear (100 normal; 98 abnormal). Women with abnormal cytology results from either specimen underwent colposcopy; 10 women with normal results from both specimens also underwent colposcopy. We calculated sensitivity of self-collected cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. One hundred and ninety-seven (99.5%) women self-collected a lavage. Seventy-five percent had moderate to excellent cellularity, two specimens were unsatisfactory for cytology. Seven of 167 (4%) women with definitive results had CIN2+; one had normal and six abnormal cytology results with the self-lavage (sensitivity = 86%, 95% Confidence Interval, CI: 42, 100). The kappa for paired cytology was low (0.36; 95% CI: 0.25, 0.47) primarily due to clinician specimens with atypical squamous cells of undetermined significance (ASC-US) and low grade squamous intraepithelial lesion (LSIL) coded as normal using Screener specimens. However, three cases of HSIL were coded as ASC-US and one as normal using Screener specimens. Seventy-three women had paired high-risk HPV tests with a kappa of 0.66 (95% CI: 0.49, 0.84). Based on these preliminary findings, a larger study to estimate the performance of the Screener for co-testing cytology and HPV or for HPV testing with cytology triage is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT00702208. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/24376516/Validity_and_reliability_of_using_a_self_lavaging_device_for_cytology_and_HPV_testing_for_cervical_cancer_screening:_findings_from_a_pilot_study_ L2 - http://dx.plos.org/10.1371/journal.pone.0082115 DB - PRIME DP - Unbound Medicine ER -