Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

Background: This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design: Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms.Discussion: This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings

Risk of high-grade cervical dysplasia and gynaecological malignancies following the cytologic diagnosis of atypical endocervical cells of undetermined significance: A retrospective study of a state-wide screening population in Western Australia

Background: In 2006, Australia adopted a revised cervical cytology terminology system, known as the Australian Modified Bethesda System (AMBS). One substantial change in the AMBS was the introduction of the diagnostic category of atypical endocervical cells (AEC) of undetermined significance. Aim: The aim of this study was to investigate the incidence of histologically confirmed high-grade cervical dysplasia (cervical intra-epithelial neoplasia (CIN) grades 2 and 3 and adenocarcinoma in situ (ACIS)), cervical carcinoma and endometrial carcinoma in women presenting with AEC on cervical cytology. Methods: A seven-year retrospective study examining clinical outcomes of women with AEC on a screening cervical smear. Cytology and histology results were extracted from the Western Australia Cervical Screening Registry, and time-to-event analysis was used to predict the odds of having or developing in situ and invasive neoplasia.Results: AEC was reported in index smears from 0.093% (584/622754) women during the study period. No follow-up was available in 35 AEC cases. Sixty-five of the remaining 549 women (11.8%) had, or developed, high-grade cervical dysplasia within five years of their index AEC diagnosis. Endometrial cancer was diagnosed in 21 women and cervical cancer in four women during the follow-up period. Conclusion: Cytologic demonstration of AEC requires careful gynaecologic evaluation, particularly in younger women who may be found to have either high-grade squamous (CIN) or glandular (ACIS) lesions, while in older women, the possibility of endometrial neoplasia needs to be considered

Risk of persistent and recurrent cervical neoplasia following incidentally detected adenocarcinoma-in-situ.

BACKGROUND: Adenocarcinoma-in-situ (AIS) of the uterine cervix is a precursor to cervical adenocarcinoma and may co-exist with both adenocarcinoma and high-grade squamous dysplasia (cervical intraepithelial neoplasia (CIN) 2 and 3). Up to 60% of AIS lesions are detected incidentally following excisional biopsies performed for the treatment of CIN 2/3. To date there are no data regarding risk factors for persisting or progressive cervical neoplasia in these patients. OBJECTIVE: To investigate patient outcomes following incidentally detected cervical AIS after loop electrosurgical excision procedure (LEEP) or cold knife cone (CKC) biopsy performed for the treatment of high-grade cervical intraepithelial neoplasia (CIN). STUDY DESIGN: A retrospective, population-based cohort study of Western Australian patients with an incidental diagnosis of AIS between 2001 and 2012. Primary outcomes were persistent or recurrent CIN 2/3 and or AIS, and invasive adenocarcinoma during follow-up (<12 months) and surveillance (=12 months) periods. RESULTS: The cohort comprised 298 patients, with 228 (76.5%) treated initially by LEEP and 70 (23.5%) treated by CKC biopsy. The mean age was 31.2 years (range 18 to 68 years) and the median length of follow-up was 2.4 years (range 0.3 to 12.2 years). Overall, 11 (3.7%) patients had CIN 2/3, 23 (7.7%) had AIS and 3 (1.0%) had adenocarcinoma diagnosed during the follow-up and surveillance periods. Age over 30 years, pure AIS lesions and larger lesions (>8mm) were associated with a greater risk of disease persistence or recurrence. CONCLUSION(S): Following the incidental detection of AIS, age >30 years, pure AIS lesions and lesions >8mm, were significantly associated with disease persistence/recurrence. In younger women, incidentally detected AIS which co-exists with CIN 2/3 and is <8mm extent with clear margins may not require re-excision