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

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

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Cervical Intraepithelial Neoplasia / virology
  • Female
  • Humans
  • Middle Aged
  • Papillomaviridae / isolation & purification*
  • Patient Satisfaction*
  • Physicians*
  • Polymerase Chain Reaction*
  • Self-Examination / methods
  • Self-Examination / standards*
  • Surgical Instruments
  • Tampons, Surgical
  • Uterine Cervical Neoplasms / virology
  • Vaginal Smears