Review of Cytologic Slides from the National Women’s Hospital, New Zealand, Cohort of Women with Cervical Intraepithelial Neoplasia 3 Diagnosed in 1955–1976

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

“…It is unlikely that bias affected the comparisons according to time period or initial management. Careful reanalysis of medical records and examination of histopathology slides and cytology smears, with excellent retrieval of material stored for up to 40 years, 9,10 has provided an objective and systematic account of the medical experience of these women. The extent of follow‐up information was enhanced by a policy of (at least) annual visits to the hospital for examinations and smears.…”

“…The Victorian Cytology Service in Melbourne, Australia reviewed the cytology using the current Australian Modified Bethesda system, ‘blind’ with respect to the original report 10 . We deemed cytology to be ‘positive’ if assessed as Papanicolaou class 3, 4 or 5, or Modified Bethesda possible or definite high grade abnormality.…”

“…These women were closely observed, but treatment with curative intent was withheld initially, and often later. While analyses of the ethical failures of the clinical study have been influential in improving processes for the proper conduct of research, 4–6 and a number of independent studies have been published using the data, 7–10 no account has been given previously of the direct effects on the women who participated.…”

Outcomes for women without conventional treatment for stage 1A (microinvasive) carcinoma of the cervix

“…All smears in the first 24 months after initial diagnosis and subsequent smears for women who developed stage 1A or higher carcinoma of the lower genital tract were reviewed, blind to the original report, by the Victorian Cytology Service in Melbourne, Australia, using the Australian Modified Bethesda System (AMBS). There was good agreement between the original and review coding ( κ = 0.79) . For smears in the first 24 months we used the review cytology whenever it was available.…”