title: Randomized clinical trial of PCR-determined human papillomavirus detection methods: self-sampling versus clinician-directed--biologic concordance and women's preferences.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Self-sampling is equivalent to clinician sampling for the detection of high-risk human papillomavirus and is acceptable to women as a yearly screen.
authors.affiliation: Department of Obstetrics and Gynecology, Dartmouth Medical School, Hannover, NH, USA. Diane.M.Harper@Darmouth.edu
authors.forename: Diane M
authors.initials: DM
authors.lastname: Harper
authors.forename: Walter W
authors.initials: WW
authors.lastname: Noll
authors.forename: Dorothy R
authors.initials: DR
authors.lastname: Belloni
authors.forename: Bernard F
authors.initials: BF
authors.lastname: Cole
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D017060:Patient Satisfaction; D010820:Physicians; D016133:Polymerase Chain Reaction; D016353:Self-Examination / Q000379:methods / Q000592:standards*; D013525:Surgical Instruments; D013630:Tampons, Surgical; D002583:Uterine Cervical Neoplasms / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000821:virology