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Posters. P2 Randomized controlled trial of the adequacy of cytological sampling with the cervex brush and aylesbury spatula: results of long‐term follow‐up
Author(s) -
Dey P.,
Stocks S. J.,
Collins S.,
Desai M.,
Wright Y.,
Woodman C.
Publication year - 2003
Publication title -
cytopathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.512
H-Index - 48
eISSN - 1365-2303
pISSN - 0956-5507
DOI - 10.1046/j.1365-2303.14.s1.1_18.x
Subject(s) - medicine , randomized controlled trial , gynecology , significant difference , brush , obstetrics , surgery , electrical engineering , engineering
A randomized controlled trial comparing the adequacy of cytological sampling using the Cervex brush and the Aylesbury spatula, published in 1996, revealed that the Cervex brush did not reduce the inadequate smear rate but smears were more likely to contain cytological abnormalities (odds ratio 1.19; P = 0.05). We report the long‐term follow‐up of women who had a normal smear during the trial. Methods The trial has been described elsewhere. 1 Matching of trial and laboratory databases identified follow‐up smears taken before 31/12/2000 from women with a normal smear during the trial. The analysis was restricted to 66 centres using the laboratory during the follow‐up period when all were supplied with the Aylesbury spatula. The Kaplan–Meier method was used to estimate the cumulative risk of cytological abnormality following a normal smear. The difference between study arms was estimated using the hazards ratio (HR) derived from a Cox proportional hazards model adjusted for the cluster‐randomized design and controlling for centre type. Results A total of 7129 women had at least one follow‐up smear: 3716 were first sampled with the Cervex brush and 3413 with the Aylesbury spatula. There was no difference between study groups in the incidence of any cytological abnormality (HR 1.11; 95% CI 0.92–1.34) or of moderate dyskaryosis or worse (HR 1.02; 95% CI 0.70–1.49). Conclusion The excess of abnormal smears observed during the trial in women sampled with the Cervex brush is unlikely to be due to earlier detection, because the incidence of cytological abnormality following a normal smear was similar in the two study arms.