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Impact of HPV sample self-collection for underscreened women in the renewed Cervical Screening Program

Megan Smith, Jie Bin Lew, Kate Simms and Karen Canfell
Med J Aust 2016; 204 (5): 194. || doi: 10.5694/mja15.00912

Summary

Objectives: In 2017, the National Cervical Screening Program in Australia will transition to 5-yearly primary HPV screening for all women, irrespective of human papillomavirus (HPV) vaccination status. As an adjunct to the mainstream program, HPV testing on self-collected samples will be offered under practitioner supervision to all unscreened and underscreened women aged 30–74 years. We quantified how different screening decisions affect the future risk of cervical cancer.

Design: Simulation of outcomes for 100 000 previously unscreened women, aged 30 years and eligible for self-collection, using a well-established model of HPV natural history and cervical screening.

Main outcome measures: Cumulative cancer diagnoses and deaths averted (compared with remaining unscreened) to age 84, number needed to treat for pre-cancer (NNT) to avert each cancer diagnosis.

Results: One round of self-collected HPV screening at age 30 years would avert 908 cancer diagnoses and 364 cancer deaths in the cohort by age 84 (NNT, 5.8). Benefits would still be achieved were self-collected screening delayed to age 40 (922 fewer diagnoses; 426 fewer deaths; NNT, 3.7) or 50 (684 fewer diagnoses; 385 fewer deaths; NNT, 3.2). However, the benefits associated with joining the mainstream screening program would be substantially larger (2002, 1623 or 1091 fewer diagnoses and NNT of 4.9, 3.7 or 3.4 by joining at age 30, 40 or 50 years respectively). The relative benefits of joining the mainstream program were similar for cohorts who had been offered vaccination.

Conclusions: Offering HPV self-collection has the potential to considerably improve outcomes for unscreened and underscreened women. Nevertheless, these findings underscore the need for concerted strategies to encourage these women to join the mainstream HPV screening program.

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  • Megan Smith1,2
  • Jie Bin Lew1
  • Kate Simms1
  • Karen Canfell1

  • 1 Cancer Council NSW, Sydney, NSW
  • 2 University of Sydney, Sydney, NSW

Correspondence: megan.smith@nswcc.org.au

Acknowledgements: 

The Policy1 model platform was developed earlier with grants from the National Health and Medical Research Council and with funding from the Medical Services Advisory Committee and Cancer Council NSW. Karen Canfell receives salary support (Career Development Fellowship) from the National Health and Medical Research Council. Megan Smith was awarded funding by the University of Sydney Postgraduate Research Support Scheme to partially reimburse travel expenses incurred to present this (and other) research at HPV2015 (Lisbon, 2015).

Competing interests:

Karen Canfell is a co-principal investigator of an investigator-initiated trial of cytology and primary HPV screening in Australia (Compass; NCT02328872) conducted and funded by the Victorian Cytology Service (VCS), a government-funded health promotion charity. The VCS has received equipment and a funding contribution for the Compass trial from Roche Molecular Systems and Ventana Inc (USA). Karen Canfell did not receive direct funding from industry for this trial or any other project, nor did her institution (Cancer Council NSW) receive such funding on her behalf.

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access_time 03:46, 4 April 2016
Melody Abikhair

Offering an adjunctive self-collection screening program to previously under and unscreened individuals is likely to carry a significant survival benefit along with reduction in morbidity associated with missed cervical cancer diagnoses. [1] However, it is crucial that this is implemented with a focus on maintaining appropriate standards of quality in order to ensure a program that is safe, effective, patient-centred, timely, efficient and equitable. [2]

Australian and international data has shown self-collection samples to be as sensitive as clinician collected samples providing PCR testing is performed. [3, 4] Further, offering a less invasive testing option to those previously not participating in screening opens an opportunity to prevent a greater amount of missed diagnoses or identification of high risk cases in a greater percentage of the population. However, ensuring adequate follow up of positive results in these patients represents a quality and safety issue, and thus a strategy to deal with this must be included in the design of the proposed program.

In the recent Australian iPAP trial, 23% of previously under or unscreened women returned a self-collected swab sample, with 45 of these testing positive for high-risk HPV 16/18. [5] Of concern, 38% of these high-risk positive women failed to go on to attend for recommended colposcopy. It is therefore vital that an appropriate follow up service is implemented to counsel all women with positive high risk results in order to ensure equal access to the provision of safe, effective and high quality care despite the influence of individual circumstances.


References

1. Smith, M., et al. Impact of HPV sample self-collection for underscreened women in the renewed Cervical Screening Program. Med J Aust, 2016. 204, 194.
2. Corrigan, J., et al., Crossing the Quality Chasm: A New Health System for the 21st Century, in Committee on Quality of Health Care in America, Institute of Medicine2001, National Academy Press: Washington DC.
3. Arbyn, M. and P.E. Castle, Offering Self-Sampling Kits for HPV Testing to Reach Women Who Do Not Attend in the Regular Cervical Cancer Screening Program. Cancer Epidemiology Biomarkers & Prevention, 2015. 24(5): p. 769-772.
4. Australian Government Department of Health. National Cervical Screening Program. Overview of the Renewal. 2014; Available from: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/content/renewal-ncsp-pres.
5. Sultana, F., et al. Home-based HPV self-sampling improves participation by never-screened and under-screened women: Results from a large randomized trial (iPap) in Australia. International Journal of Cancer, 2016. DOI: 10.1002/ijc.30031.


Competing Interests: No relevant disclosures

Dr Melody Abikhair
Monash University

access_time 11:43, 6 April 2016
Jane Williams

This paper and editorial (1) are based on two under-explored assumptions: 1) in-clinic self-testing will increase recruitment; and 2) women who self-test will receive adequate follow-up.
1. Both papers cite evidence that self-testing uptake is higher than Pap testing uptake in un- and under-screened populations; however these sources report studies of women self-testing at home, not in-clinic. The generalisability across these settings is unclear, and can reasonably be doubted. Barriers to screening have been classified into test-related, clinical, and personal barriers.(2) Self-testing may overcome test-related barriers. However in-clinic self-testing seems unlikely to overcome clinical barriers (e.g. lack of family physician, inconvenient hours, lack of transportation), or personal barriers (e.g. cultural beliefs, language barriers, lack of knowledge of cervical screening).
2. Women from the lowest SES quintile are least likely to 1) be screened,(3) and 2) to receive follow-up investigation and treatment.(4, 5) Even if in-clinic self-testing increases participation in screening for these under-served women, they will require substantial structural intervention to increase participation in follow-up. Such intervention does not appear to be included in the renewal plan. As screening is non-beneficial without follow-up, failure to improve follow-up means clinic-based self-testing may not offer additional benefit to under-served women.
Flexibility in screening pathways could potentially make cervical screening relevant to more Australian women, and this would be welcome. It is not clear, however, how well offers of in-clinic self-testing will translate into benefits for women.


1. Farnsworth A. Self-sampling HPV testing versus mainstream cervical screening and HPV testing. Med J Aust. 2016;204(5):171.
2. Racey C, Withrow D, Gesink D. Self-collected HPV Testing Improves Participation in Cervical Cancer Screening: A Systematic Review and Meta-analysis. Canadian Journal of Public Health. 2013;104(2):e159-e66.
3. Australian Institute of Health and Welfare. Cervical screening in Australia 2012-2013. Canberra: 2015.
4. Giorgi Rossi P, Baldacchini F, Ronco G. The Possible Effects on Socio-Economic Inequalities of Introducing HPV Testing as Primary Test in Cervical Cancer Screening Programs. Frontiers in oncology. 2014;4:20.
5. Douglas E, Wardle J, Massat NJ, Waller J. Colposcopy attendance and deprivation: A retrospective analysis of 27,193 women in the NHS Cervical Screening Programme. Br J Cancer. 2015;113(1):119-22.


Competing Interests: No relevant disclosures

Ms Jane Williams
Centre for Values, Ethics & Law in Medicine (VELiM), University of Sydney

access_time 09:03, 2 May 2016
Megan Smith

We agree with Abikhair and Williams that quality standards and broader program issues will be critical to the success of HPV self-collection. Quality standards, clinical guidelines and training materials are currently being developed, as is legislation to support the National Cancer Register(1). The new National Cancer Register will play a key role in the follow-up of screen-positive women, which we agree is essential. The iPap trial found that 76% of screen-positive women received appropriate clinical follow-up within six months, but that Pap test results appeared to influence colposcopy referral among women who tested positive for HPV16/18(2). However since this trial, clear guidelines have been developed recommending that women with HPV16/18 detected in a self-collected sample be referred directly to colposcopy and that a cytology sample should be obtained at colposcopy (rather than before)(3).

While self-collection (home- or clinic-based) can address multiple identified barriers to screening, such as those related to the physical or emotional experience of the test or specific to providers (4), we agree with Williams that self-collection cannot address them all. However not understanding the benefit of screening is another important barrier (4); this is where we hope the quantitative results of this analysis could help, for example via a decision aid. Our study makes no assumptions about the proportion of under/unscreened women in the population who would accept self-collection; rather, the explicit aim of our analysis was to explore the ramifications of making different choices to assist women and providers and inform decision-making(5).

References
1. Department of Health. Renewal of the National Cervical Screening Program Partner Reference Group E-newsletter – February 2016. Available from: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/52DF583BA30DCAD4CA257CED00801847/$File/2016-02-17-Partner-Reference-Group-E-newsletter.pdf.
2. Sultana F, English DR, Simpson JA, Drennan KT, Mullins R, Brotherton JM, et al. Home-based HPV self-sampling improves participation by never- and under-screened women: Results from a large randomised trial (iPap) in Australia. Int J Cancer. 2016 doi: 10.1002/ijc.30031
3. Cancer Council Australia Cervical Cancer Prevention Guidelines Working Party. Draft clinical management guidelines for the prevention of cervical cancer. 2016 [cited 18/2/2016]; Available from: http://wiki.cancer.org.au/australia/Guidelines:Cervical_cancer/Prevention.
4. Chorley AJ, Marlow LAV, Forster AS, Haddrell JB, Waller J. Experiences of cervical screening and barriers to participation in the context of an organised programme: a systematic review and thematic synthesis. Psycho-Oncology. 2016. doi: 10.1002/pon.4126
5. Smith M, Lew JB, Simms K, Canfell K. Impact of HPV sample self-collection for underscreened women in the renewed Cervical Screening Program. MJA 2016;21;204:194. doi: 10.5694/mja15.009

Competing Interests: KC is co-PI of an investigator-initiated trial of cytology and primary HPV screening in Australia (‘Compass’) (ACTRN12613001207707 and NCT02328872), which is conducted and funded by the Victorian Cytology Service (VCS) Inc Ltd., a government-funded health promotion charity. The VCS Inc Ltd. have received equipment and a funding contribution for the Compass trial from Roche Molecular Systems and Ventana Inc USA. KC is also a PI on Compass in New Zealand, (‘Compass NZ’) (ACTRN12614000714684) which is conducted and funded by Diagnostic Medlab, now Auckland District Health Board. DML received an equipment and a funding contribution for the Compass trial from Roche Molecular Systems. However neither KC nor her institution on her behalf (Cancer Council NSW) receive direct or indirect funding from industry for Compass Australia or NZ or any other project.

Ms Megan Smith
Cancer Council NSW, University of Sydney

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