title: Feasibility of management of high-grade cervical lesions in a single visit: a randomized controlled trial.
abstract: BACKGROUND
  The incidence of cervical cancer is higher among low-income and minority women who have never undergone a conventional Papanicolaou test or who do not follow up after testing. Screening has been shown to reduce cervical cancer incidence rates.
  
  
  OBJECTIVE
  To determine the feasibility and acceptability of immediately treating women with severely abnormal Papanicolaou test results by using a single-visit cervical cancer screening and treatment program and to compare treatment rates and 12-month follow-up rates with those of women who received usual care.
  
  
  METHODS
  Randomized controlled trial conducted among 3521 women aged 18 years or older recruited between January 1999 and April 2002 at US community health centers located in predominantly Latino underserved areas.
  
  
  METHODS
  Women randomized to usual care (n = 1805) were discharged immediately after examination. Women randomized to the single-visit group (n = 1716) remained at the clinic until the results of their conventional Papanicolaou test were available. Large loop electrosurgical excision procedure was performed in single-visit patients with either a diagnosis of a high-grade squamous intraepithelial lesion (HGSIL)/atypical glandular cells of undetermined significance (AGUS) or suspicion of carcinoma. All other patients with abnormal Papanicolaou test results were referred to abnormal cytology clinics or elected to receive follow-up care outside the study's medical system.
  
  
  METHODS
  Treatment rates for HGSIL/AGUS at 6 months, follow-up rates at 6 months for lower-grade lesions, and 1-year follow-up rates for all patients.
  
  
  RESULTS
  The rate of abnormal Papanicolaou test results was 4.1%. One percent of results showed high-grade lesions. In the single-visit group, the mean visit time was 2.8 hours and the mean time for delivery and processing of the Papanicolaou tests was 66 minutes. Six months after randomization, 14 (88%) of 16 single-visit and 10 (53%) of 19 usual care patients with HGSIL/AGUS had completed treatment. Fifty percent in the single-visit program and 53% of usual care with less abnormal Papanicolaou tests completed treatment within 6 months. Overall, 36% in each group presented for a follow-up Papanicolaou test 1 year later. Women in the single-visit group with high-grade lesions (10/16; 63%) were significantly more likely to attend follow-up for Papanicolaou tests 12 months later than women with similar lesions in the usual care group (4/19; 21%).
  
  
  CONCLUSIONS
  For cervical cancer screening, the single-visit program was feasible and the degree of acceptability was high in this underserved population. Single visit programs provide an opportunity to increase the rate of immediate treatment and follow-up of women with severely abnormal Papanicolaou test results. This strategy did not improve follow-up rates for women with less-abnormal results. Trial Registration http://ClinicalTrials.govIdentifier: NCT00237562.
authors.affiliation: Department of Medicine, School of Medicine, University of California, Irvine 92868-3200, USA. wrbrewst@uci.edu
authors.forename: Wendy R
authors.initials: WR
authors.lastname: Brewster
authors.forename: F Allan
authors.initials: FA
authors.lastname: Hubbell
authors.forename: Joan
authors.initials: J
authors.lastname: Largent
authors.forename: Argyrios
authors.initials: A
authors.lastname: Ziogas
authors.forename: Fritz
authors.initials: F
authors.lastname: Lin
authors.forename: Susan
authors.initials: S
authors.lastname: Howe
authors.forename: Theodore G
authors.initials: TG
authors.lastname: Ganiats
authors.forename: Hoda
authors.initials: H
authors.lastname: Anton-Culver
authors.forename: Alberto
authors.initials: A
authors.lastname: Manetta
mesh_terms: D000328:Adult; D002140:California; D003151:Community Health Centers; D004598:Electrosurgery; D005240:Feasibility Studies; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D008403:Mass Screening; D008507:Medically Underserved Area; D008875:Middle Aged; D009819:Office Visits; D065006:Papanicolaou Test; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000208:ethnology / Q000628:therapy*; D014626:Vaginal Smears