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Randomized clinical trial of PCR-determined human papillomavirus detection methods: self-sampling versus clinician-directed--biologic concordance and women's preferences.

作者信息

Harper Diane M, Noll Walter W, Belloni Dorothy R, Cole Bernard F

机构信息

Department of Obstetrics and Gynecology, Dartmouth Medical School, Hannover, NH, USA.

出版信息

Am J Obstet Gynecol. 2002 Mar;186(3):365-73. doi: 10.1067/mob.2002.121076.

DOI:10.1067/mob.2002.121076
PMID:11904593
Abstract

OBJECTIVE

The purpose of this study was to compare the high-risk human papillomavirus detection rates from self-sampled swabs and tampons with standard clinician-directed speculum sampling and to assess women's acceptance of self-sampling methods.

STUDY DESIGN

One hundred three women who required a colposcopy underwent order randomization of the human papillomavirus sampling technique. Kappa and McNemar test statistical results were used to measure the agreement between clinician-directed and self-sampling techniques for high-risk types of human papillomavirus and the acceptance of self-sampling techniques.

RESULTS

All self-directed samplings were equivalent to clinician sampling for all cervical intraepithelial neoplasia disease states. High-risk human papillomavirus was detected by self- and clinician-directed methods in 83% of the women with cervical intraepithelial neoplasia, grade 2/3. The 2 sequential swabs trend toward better detection of high-risk types of human papillomavirus than all other techniques for women with normal histologic factors (P =.0736, by McNemar's chi2 test). Ninety-four percent of women would accept self-sampling for their yearly cervical screen.

CONCLUSION

Self-sampling is equivalent to clinician sampling for the detection of high-risk human papillomavirus and is acceptable to women as a yearly screen.

摘要

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