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Consequences in women of participating in a study of the natural history of cervical intraepithelial neoplasia 3.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	McCredie, Margaret R. E. Paul, Charlotte Sharples, Katrina J. Baranyai, Judith Medley, Gabriele Skegg, David C. G. Jones, Ronald W.
Spatial Coverage	New Zealand
Description	Country affiliation: New Zealand Author Affiliation: McCredie MR ( Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.)
Abstract	BACKGROUND: A retrospective cohort study was performed in 1063 women diagnosed with cervical intraepithelial neoplasia grade 3 (CIN3) (previously termed carcinoma in situ- CIS) in the National Women's Hospital, Auckland, New Zealand. The study describes the clinical management and outcomes for women with CIN3 diagnosed in the decade of 1965-1974, when treatment with curative intent was withheld in an unethical clinical study of the natural history of CIS. A comparison is made with women who were diagnosed earlier (1955-1964) and later (1975-1976). AIMS: The aim of the study is to record the medical encounters, frequency and management of cytological abnormalities and the occurrence of invasive cancers. The medical records, cytology and histopathology were reviewed and data linked with cancer and death registers. RESULTS: Women diagnosed with CIN3 in 1965-1974 (n = 422), compared with those diagnosed earlier (n = 385) or later (n = 256): (i) were less likely to have initial treatment with curative intent (51% vs 95 and 85%, respectively); (ii) had more follow-up biopsies (P < 0.0005); (iii) were more likely to have positive cytology during follow-up (P < 0.005) and positive smears that were not followed within six months by a treatment with curative intent (P < 0.005); and (iv) experienced a higher risk of cancer of the cervix or vaginal vault (RR = 3.3 compared with the first period, 95% CI: 1.7-5.3). Among women diagnosed in 1965-1974, those initially managed by punch or wedge biopsy alone had a cancer risk ten times (95% CI: 3.9-25.7) higher than women initially treated with curative intent. CONCLUSIONS: During the 'clinical study' (1965-1974), women underwent numerous interventions that were aimed to observe rather than treat their condition, and their risk of cancer was substantially increased.
File Format	HTM / HTML
ISSN	00048666
Issue Number	4
Volume Number	50
e-ISSN	1479828X
Journal	Australian and New Zealand Journal of Obstetrics and Gynaecology
Language	English
Publisher	Wiley
Publisher Date	2010-08-01
Publisher Place	Australia
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Obstetrics Discipline Gynecology Cervical Intraepithelial Neoplasia Pathology Uterine Cervical Neoplasms Adolescent Adult Aged Biopsy Mortality Therapy Disease Management Disease Progression Female Humans Incidence Kaplan-meier Estimate Middle Aged Neoplasm Invasiveness New Zealand Refusal To Treat Ethics Time Factors Vaginal Neoplasms Vaginal Smears Young Adult Comparative Study Journal Article Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Obstetrics and Gynecology

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