Appendix J. Safety monitoring of the Renewed cervical screening program

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Background

The National Cervical Screening Program (NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears.) Safety Monitoring Committee (SMC) was established in 2005 in response to the National Health and Medical Research Council’s (NHMRCNational Health and Medical Research Council) 2005 Guidelines “Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen detected abnormalities.”[1]It was established due to concerns some stakeholders raised regarding the change in management of women with low grade abnormalities and treated high grade abnormalities, from the 1994 guidelines.

The safety monitoring methodology estimated 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. A cohort study design was used to select individuals who entered the study at a given time, either following a low-grade Pap test or a histologically confirmed high grade intraepithelial abnormality, and were followed up for five years. The number of women diagnosed with cervical cancer was counted during the follow up time and rate ratios (hazard rates) of cervical cancer were calculated using proportional hazards regression modelling.

Safety monitoring analyses to date have not raised any safety concerns and the outcomes have reassured stakeholders regarding the safety of the 2005 Guidelines.[2]Furthermore, the safety monitoring process has demonstrated the importance of monitoring the outcomes of the National Cervical Screening Program more broadly in a changing environment.

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Quality and Safety Monitoring Committee

The Quality and Safety Monitoring Committee (QSMC) was established in 2014 in response to the Medical Services Advisory Committee recommendations to replace the two yearly Pap test with a five yearly HPV test for the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears.. The QSMC replaced the SMC as it was recognised that this significant change to the screening program would require a broader remit than that of the SMC.

The QSMC has a role in monitoring the quality and safety of the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. and reports to the Standing Committee on Screening of the Australian Health Ministers’ Advisory Council. The QSMC is developing a quality and safety monitoring programme as part of a Quality Framework for the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears.. The Framework will be available from the cancerscreening.gov.au website following its approval by the Standing Committee on Screening.

The Quality Framework includes a set of Quality Standards, Measures and Benchmarks across the cervical screening pathway including colposcopy and these will be monitored by the QSMC on an annual basis. A process for the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. to address quality issues is also presented in the Framework.

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Safety Monitoring

The Quality Framework will also include safety monitoring parameters across the cervical screening pathway to ensure the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. remains safe at this time of significant change. The methodology for safety monitoring will be developed following the finalisation of these Clinical Management Guidelines however will be informed by the safety monitoring approach being undertaken as part of the COMPASS clinical trial in Victoria.[3]

The QSMC will review the safety monitoring parameters on an annual basis and provide advice to the Standing Committee on Screening should any safety concerns arise. Further information on this process is described in the Quality Framework.

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References

  1. National Health and Medical Research Council. Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen detected abnormalities. Canberra: NHMRCNational Health and Medical Research Council; 2005.
  2. Australian Institute of Health and Welfare. Report on monitoring activities of the National Cervical Screening Program Safety Monitoring Committee. Cancer series 80. Cat. no. CAN 77. Canberra: AIHWAustralian Institute of Health and Welfare; 2013 Available from: http://www.aihw.gov.au/publication-detail/?id=60129545158).
  3. Canfell K, Castle P, Caruana M, Gebski V, Darlington-Brown J, Heley S, Brotherton J, Gertig D, Saville M. Protocol for Compass: a randomised controlled trial of primary HPV vs. cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women in Australia. Victorian Cytology Service Inc and The University of Sydney 2014.