Feasibility of Management of High-Grade Cervical Lesions in a Single Visit: A Randomized Controlled Trial

Abstract

In this randomized, controlled trial, women from underserved neighborhoods who underwent cervical screening were either managed in the usual fashion and notified of their results with a recommendation for follow up at a later visit or treated in the same visit. Women in the “usual-care” group were dismissed after pelvic examination and Pap smear, and test results were mailed to them. If the smears were abnormal, they were contacted by phone and referred for additional evaluation either within the authors’ clinical system or to their primary care physician with a written copy of their test results. Follow-up information for usual-care patients with abnormal test results was obtained from the patient and from a review of medical records. Participants were told to return for a follow-up examination in 12 months. Women randomized to the “single-visit” group remained after the examination until the results of the cervical smear were known. If the findings were atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous epithelial lesion (LGSIL), the women were referred for additional evaluation as in the usual group. Patients whose smears were positive for high-grade squamous intraepithelial lesion (HGSIL), atypical glandular cells (AGUS), or carcinoma underwent immediate treatment with cervical loop electrosurgical procedure (LEEP). Neither colposcopy nor endocervical excision was performed; however, endometrial biopsies were taken in patients with AGUS. All LEEP patients were asked to return in 2 weeks and at 3 and 12 months for follow up. A total of 3521 women recruited from community health centers in primarily Latino neighborhoods participated in the study. One thousand seven hundred sixteen were randomly assigned to the single-visit group, and 1805 were assigned to the usual group. There was no difference in the rate of abnormal cervical smears (approximately 4% each) or in the rate of high-grade lesions (1%) between the two groups. Fourteen of 16 (88%) women with high-grade lesions in the single-visit group received definitive treatment compared with 10 of 19 (53%) women with a similar diagnosis in the usual-care group (P = .04). One of the two single-visit patients left before her results were known, and one refused treatment. Thirteen of 19 usual-care patients were evaluated with colposcopy within 6 months of the cervical screening, but only 10 were treated as recommended. Treatment and evaluation of low-grade abnormalities were similar for both groups of patients. Two patients, one in the single-visit group and one in the usual-care group, were found to have invasive cancer in the LEEP specimen. Thirty-six percent of patients in each treatment group returned for the follow-up Pap smear at 12 months. Among women with high-grade lesions, more patients in the single-visit group attended the 1-year examination (10 of 16, 63%) than did women in the usual-care group (4 of 19, 21%) (P = .02). The time each woman spent in the clinic was recorded. The mean time from registration to discharge was 2.8 hours for single-visit patients and 1.25 hours for usual-care patients. Responses on a patient questionnaire indicated that 76% of single-visit patients felt that the duration of the first visit was acceptable compared with 89% of those in the usual-care group (P < .001). Ninety-five percent of single-visit women would choose to have a single-visit screening again, and 67% of usual-care patients indicated they would have preferred to wait for results at the same visit.