TY - JOUR
T1 - Post-colposcopy Management of ASC-US and LSIL Pap Tests (PALS Trial)
T2 - Pilot RCT
AU - Saciragic, Lana
AU - Nelson, Gregg
AU - Chiarella-Redfern, Helene
AU - Kanarek, Norma
AU - Nation, Jill
AU - Duggan, Máire A.
N1 - Funding Information:
Financial support for this project was provided by an unrestricted research grant from the Tom Baker Cancer Centre. Tom Baker Cancer Centre had no role in study design, implementation, data analysis, or writing of this manuscript. The funds were used for logistical purchases related to study implementation (subscription to randomization tool Randomize.net and stationary). The authors would like to acknowledge non-financial support provided by Hologic, which arranged the HPV testing in an external laboratory of Rob Nicholson, Path QC, Montreal, QC. Hologic had no role in the analysis or interpretation of the data. The authors would like to thank Selphee Tang for her statistical support.
Publisher Copyright:
© 2019 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada.
PY - 2019/7
Y1 - 2019/7
N2 - Objective: Evidence supporting optimal follow-up of women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion cytology found to have low-grade disease or normal findings at initial colposcopy is weak. Surveillance options include continued colposcopy, discharge with Pap testing, or HPV testing at 12 months. This study was a pilot RCT comparing these three follow-up policies. The objectives were to determine the feasibility of an RCT and to compare the incidence of greater than or equal to high-grade squamous intraepithelial lesion (≥HSIL) in each of the follow-up policies. Methods: A total of 133 women referred with ASC-US or low-grade squamous intraepithelial lesion cytology between June and August 2012 underwent initial colposcopy where incident ≥HSIL histology was ruled out. Of these women, 125 were randomly assigned to colposcopic surveillance, Pap testing, or HPV testing. Patients with high-risk results at any point were treated according to standard of care. Patient recruitment and adherence to follow-up were calculated using descriptive statistics. Accuracy of the three follow-up arms was calculated (Canadian Task Force Classification: IC). Results: Recruitment rates were 80%, and adherence to protocol was 85% to 100%. Nine of 125 (7.2%) patients overall were found to have ≥HSIL histology at exit: one of 43 in the reference colposcopy group, and six of 41 and three of 41 in Pap and HPV arms, respectively. One early cancer was detected in the HPV arm. Sensitivity and specificity (CI) for each arm, respectively, were as follows: colposcopy N/A, 100% (88.1%–100%); Pap, 100% (47.8%–100%) and 85.7% (63.7%–97%); and HPV, 66.7% (9.4%–99.2%) and 68% (46.5%–85.1%). Conclusion: This pilot study demonstrated the operational and safety feasibility of an RCT in this patient population. Validation of clinical findings is necessary.
AB - Objective: Evidence supporting optimal follow-up of women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion cytology found to have low-grade disease or normal findings at initial colposcopy is weak. Surveillance options include continued colposcopy, discharge with Pap testing, or HPV testing at 12 months. This study was a pilot RCT comparing these three follow-up policies. The objectives were to determine the feasibility of an RCT and to compare the incidence of greater than or equal to high-grade squamous intraepithelial lesion (≥HSIL) in each of the follow-up policies. Methods: A total of 133 women referred with ASC-US or low-grade squamous intraepithelial lesion cytology between June and August 2012 underwent initial colposcopy where incident ≥HSIL histology was ruled out. Of these women, 125 were randomly assigned to colposcopic surveillance, Pap testing, or HPV testing. Patients with high-risk results at any point were treated according to standard of care. Patient recruitment and adherence to follow-up were calculated using descriptive statistics. Accuracy of the three follow-up arms was calculated (Canadian Task Force Classification: IC). Results: Recruitment rates were 80%, and adherence to protocol was 85% to 100%. Nine of 125 (7.2%) patients overall were found to have ≥HSIL histology at exit: one of 43 in the reference colposcopy group, and six of 41 and three of 41 in Pap and HPV arms, respectively. One early cancer was detected in the HPV arm. Sensitivity and specificity (CI) for each arm, respectively, were as follows: colposcopy N/A, 100% (88.1%–100%); Pap, 100% (47.8%–100%) and 85.7% (63.7%–97%); and HPV, 66.7% (9.4%–99.2%) and 68% (46.5%–85.1%). Conclusion: This pilot study demonstrated the operational and safety feasibility of an RCT in this patient population. Validation of clinical findings is necessary.
KW - Colposcopy
KW - HPV
KW - Papanicolaou test
KW - cervical intraepithelial neoplasia
KW - low-grade abnormalities
KW - uterine cervical neoplasm
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UR - http://www.scopus.com/inward/citedby.url?scp=85055638418&partnerID=8YFLogxK
U2 - 10.1016/j.jogc.2018.08.004
DO - 10.1016/j.jogc.2018.08.004
M3 - Article
C2 - 31230661
AN - SCOPUS:85055638418
SN - 1701-2163
VL - 41
SP - 916
EP - 925
JO - Journal of Obstetrics and Gynaecology Canada
JF - Journal of Obstetrics and Gynaecology Canada
IS - 7
ER -