Randomized clinical trial of PCR—determined human papillomavirus detection methods: Self-sampling versus clinician-directed—Biologic concordance and women's preferences

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OBJECTIVEThe 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 DESIGNOne 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.RESULTSAll 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 χ2 test). Ninety-four percent of women would accept self-sampling for their yearly cervical screen.CONCLUSIONSelf-sampling is equivalent to clinician sampling for the detection of high-risk human papillomavirus and is acceptable to women as a yearly screen. (Am J Obstet Gynecol 2002;186:365-73.)

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