Randomized clinical trial of PCR–determined human papillomavirus detection methods: Self-sampling versus clinician-directed–Biologic concordance and womenʹs preferences

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 womenʹs 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 McNemarʹs χ2 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. (Am J Obstet Gynecol 2002;186:365-73.)