Safety Monitoring Committee
In late 2005, the Safety Monitoring Committee (SMC) was established to monitor the safety of the Guideline recommendations for the management of women with low grade cervical cytology results and women treated with high grade intra epithelial disease, and provide timely review of policy as needed.
Membership of the Committee consists of:
- Statisticians;
- Epidemiologists;
- a representative of the Royal Australian College of General Practitioners (RACGP);
- a representative of the Royal College of Pathologists of Australia (RCPA);
- a representative of the Royal Australian and New Zealand College Obstetricians and Gynaecologists (RANZCOG);
- a National Cervical Screening Program (NCSP) program manager and data manager;
- a representative of the Australian Society for Colposcopy and Cervical Pathology (ASCCP);
- a representative of the Australasian Association of Cancer Registers(AACR);
- a representative of the Australian Institute of Health and Welfare (AIHW);
- a consumer representative; and
- officers of the Department of Health and Ageing.
The Safety Monitoring Methodology
One of the first tasks of the SMC was to identify a method for monitoring the safety of the Guidelines. Dr Mark Clements of the National Centre for Epidemiology and Population Health at the Australian National University was engaged to investigate possible methodologies. A final methodology was developed and accepted by the Safety Monitoring Committee at its 20 July 2007 meeting.The methodology estimates the change in rate of cervical cancer incidence following low grade cytology or a treated high-grade intraepithelial abnormality under the 2005 Guidelines relative to the 1994 Guidelines. This statistical approach does not take account of mortality or other forms of burden of disease and may require further investigation in order to explain any changes over time.
A cohort study design is being used to select individuals who enter the study at a given time, either following a low-grade Pap test or a histologically confirmed high grade intraepithelial abnormality, and are followed up for five years. The number of women diagnosed with cervical cancer will be counted during the follow up time and rate ratios (hazard rates) of cervical cancer will be calculated using proportional hazards regression modelling. Due to the sequential nature of the monitoring process an adjustment is being made to account for the errors associated with multiple testing.
In addition to the cohort analyses, a review of all cancers arising in women following an incident low grade Pap test or histologically confirmed high-grade intra-epithelial abnormality, both pre and post guidelines, is being conducted. This review will provide additional information about the circumstances in which these cancers arose, based on data provided by the Pap test registries, and will supplement the statistical analyses.
A detectable difference in the rate ratios will be determined given a fixed sample size, α-level of significance and power. The SMC agreed that a ‘warning’ flag would be raised if safety monitoring parameters exceeded the 10% (adjusted) α-level and an ‘immediate action required’ flag if the parameters exceeded the 5% (adjusted) α-level. If either of these flags are triggered the SMC would immediately notify the Screening Subcommittee and provide advice on whether there was a need to re-evaluate the Guidelines.
Data Collection and Analysis
The Department of Health and Ageing engaged the Australian Institute of Health and Welfare (AIHW) to act as the monitoring body for the SMC. The AIHW is responsible for the collection of data, statistical analysis, monitoring of parameters and reporting to the SMC on the analyses.Data are being collected for periods both pre- and post-Guidelines implementation. Pre Guidelines data will act as baseline information and be used to measure cervical cancer incidence for women in the cohorts prior to the implementation of the Guidelines. The SMC methodology allows for a six-month change over period, during which clinical practice may be expected to reflect a mixture of both 1994 and 2005 Guidelines practice; therefore post-Guidelines data collection for safety monitoring will begin from 1 January 2007.
Page currency, Latest update: 03 February, 2012