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Queensland Cervical Screening Program - Handbook for Providers of Medical Practitioner Education. Second edition provides a review of current information relating to cervical cancer incidence and mortality, participation in cervical screening, Human Papillomavirus vaccination and new technologies. The second edition is produced in a CD format to facilitate wider distribution and easy access for students and all those involved in provision of medical education.
Queensland Cervical Screening Program - Handbook for Providers of Medical Practitioner Education. Second edition provides a review of current information relating to cervical cancer incidence and mortality, participation in cervical screening, Human Papillomavirus vaccination and new technologies. The second edition is produced in a CD format to facilitate wider distribution and easy access for students and all those involved in provision of medical education.
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Queensland Cervical Screening Program - Handbook for Providers of Medical Practitioner Education. Second edition provides a review of current information relating to cervical cancer incidence and mortality, participation in cervical screening, Human Papillomavirus vaccination and new technologies. The second edition is produced in a CD format to facilitate wider distribution and easy access for students and all those involved in provision of medical education.
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Revised Edition June 2009 Medical Practitioner Education Cervical Screening Program Queensland Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Acknowledgements Medical Practitioner Education CERVICAL SCREENING HANDBOOK FOR PROVIDERS OF ACKNOWLEDGEMENTS The production of the Cervical Screening Handbook for Providers of Medical Practitioner Education in Queensland has been made possible through the expert advice, guidance and support of the Queensland Cervical Screening Program Medical Practitioner Training Project Reference Group The Queensland Cervical Screening Program would like to acknowledge the following people for their contributions to the development of the Handbook: Dr Beris Joyner Dr Caroline Harvey Dr Glenda Nolan Dr Jill Thistlethwaite Dr Margaret Culpin Dr Marie-Louise Dick Dr Patricia Stuart Dr Patrick Byrnes Dr Tracey Chefns Dr Vivienne OConnor Ms Anna Voloschenko Ms Jennifer Muller Ms Kim Rogers Ms Leane Christie Ms Lisa Peberdy PowerPoint Presentation: Dr Kay Strom Dr James Nicklin Prof Ian Frazer North Queensland Works Unit The Cervical Screening Handbook for Providers of Medical Practitioner Education was endorsed in July 2006 by the Queensland Cervical Screening Program Quality Management Committee. The second edition was endorsed by the Queensland Cervical Screening Program Quality Management Committee on 9 April 2009. Queensland Cervical Screening Program Cancer Screening Services Unit Population Health Queensland PO Box 2368 Fortitude Valley BC QLD 4006 Telephone: (07) 3328 9467 Facsimile: (07) 3328 9487 ISBN 192 1021 500 June 2009 Page iv Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education FOREWORD The second edition of the Cervical Screening Handbook for Providers of Medical Education provides a review of current information relating to cervical cancer incidence and mortality, participation in cervical screening, Human Papillomavirus vaccination and new technologies. The second edition is produced in a CD format to facilitate wider distribution and easy access for students and all those involved in provision of medical education. The second edition of the Handbook can be sighted or downloaded from the Queensland Cervical Screening Program website: www.health.qld.gov.au/cervicalscreening Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 1 This Handbook has been conceived and produced to assist providers of medical education in Queensland with information about all aspects of cervical screening. The initiative for this project came from the Queensland Cervical Screening Program Medical Practitioner Education Project Reference Group whose task was to identify and propose strategies to ensure that medical practitioners practising in Queensland have access to appropriate training and continuing education in the area of cervical screening. An extensive needs analysis was conducted as part of this project to inform the scope and presentation of this Handbook. The following content areas were specied by the Reference Group as essential components that should be included in any Medical Practitioner cervical screening education program: incidence , mortality and aetiology of cervical cancer including the role of the Human papillomavirus (HPV) and other risk factors principles of population health and screening including systematic approaches to screening health promotion and cervical screening National Cervical Screening Policy for the prevention of cervical cancer and the NHMRC Guidelines for the treatment of asymptomatic women with screen detected abnormalities cervical screening pathway barriers affecting womens participation in regular cervical screening new technologies clinical skills including basic theory and clinical experience in performing a Pap smear, interaction and communication skills in performing sensitive gynaecological examinations, interpretation of cytology reports, follow-up and referral practices quality assurance activities including principles of risk management, recall and reminder systems, The Queensland Health Pap Smear Register, interpreting quality assurance reports and clinical audits. Introduction Cervical screening is a disease prevention activity that ts well into general practice. This Handbook for providers of medical education in Queensland has been prepared with this in mind. Page 2 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education To support registrars, supervisors and others who are involved in medical education this Handbook has utilised the concepts of The Royal Australian College of General Practitioners Training Programs Five Domains of general practice which are: 1. Communication skills and the patient-doctor relationship 2. Applied professional knowledge and skills 3. Population health and the context of general practice 4. Professional and ethical role 5. Organisational and Legal Dimensions. Table 1. This table illustrates how sections and learning objectives in this Handbook t into the RACGP Curriculum framework. The Handbook consists of ve sections. Each section has a Summary of Information which gives a prcis of the section, lists key concepts for inclusion in education programs and lists learning outcomes. Supporting Information in each section contains a summary of current information, references, additional readings and support materials that can be used to develop education sessions. The variety of materials contained in this Handbook can be adapted to many modes of presentation or preferred method of delivery e.g. small groups, lecture room delivery, self-directed or interactive learning. Furthermore it is recognised that the target audience will be at different levels of professional development such as medical students, registrars and general practitioners, and internationally trained medical graduates. The resource therefore has been designed to allow for the educator to choose the materials which are most suitable to the group that needs to be addressed. PowerPoint presentations relevant to each chapter are provided to assist with session preparation and presentation. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 3 Domains of General Practice Handbook Sections as they relate to the Domains of General Practice Communication Skills and the Doctor-Patient relationship communlcallon skllls ncccssary lo crorm scnslllvc gynaccologlcal examination such as a Pap smear (Section 4.1) skllls lo undcrlakc cccllvc hcallh cducallon and hcallh romollon within the context of cervical screening (Section 3) skllls lo undcrlakc oorlunlsllc ccrvlcal scrccnlng Sccllon 8} communlcallon wllh Aborlglnal and !orrcs Slrall lslandcr womcn, lesbian women, women with disabilities and women from culturally and linguistically diverse backgrounds ( Section 3.2) barrlcrs accllng womcn's arllclallon ln rcgular ccrvlcal scrccnlng (Section 3.2) Applied professional knowledge and skills knowlcdgc o ccrvlcal scrccnlng lncludlng lhc hallonal Scrccnlng Pollcy and screening pathway, NHMRC Guidelines (Sections 2.1,4.3,4.4) skllls ln undcrlaklng lhc Pa smcar roccdurc Sccllon 4.2} ncw lcchnologlcs Sccllon 4.} cllnlcal dcclslon maklng on lhc basls o rcsulls rccclvcd Sccllon 4.8} conllnully and lnlcgrallon o carc Sccllon 4.6} Population health in the context of General Practice rlncllcs o oulallon hcallh and oulallon scrccnlng Sccllons 2.1} demographics, epidemiology and aetiology of cervical cancer ( Section1.1, 1.2) dlscasc rcvcnllon and hcallh romollon ln conlcxl o ccrvlcal scrccnlng eg participation in community based prevention and education strategies ( Section 3) skllls ln advocacy and ln uslng communlly rcsourccs Sccllon 8} the importance of a public health perspective in general practice (Section 3) Professional and Ethical role rlsk managcmcnl Sccllon 6.1} cullurc and valucs and lhclr lmacl on lhc lhcracullc rclallonshl (Section 3.2) allcnls rlghl Sccllons 4.1,4.2,4.6,6.8} Table 1: Sections and learning objectives within the RACGP Curriculum framework. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 5 Contents Introduction 1 Contents 5 SECTION 1 Cervical Cancer Background Information 1.1 Cervical Cancer Incidence and Mortality 1.2 Aetiology of Cervical Cancer
7 15 SECTION 2 Population Screening for Cervical Cancer 2.1 Principles of Population Screening and the National Cervical Screening Program
21 SECTION 3 Health Promotion in the Context of Cervical Screening 3.1 Health Promotion and Cervical Screening 3.2 Barriers Affecting Womens Participation in Regular Cervical Screening
31 41 SECTION 4 Clinical Skills 4.1 Communication Skills Involved in Performing Sensitive Gynaecological Examinations 4.2 The Pap Smear 4.3 Interpretation of Cytology Reports 4.4 Management of Screen Detected Abnormalities 4.5 Follow up and Referral 4.6 New Technologies 4.7 HPV Vaccination and HPV DNA Testing
51 57 63 71 75 81 87 SECTION 5 Quality Assurance Activities 5.1 Risk Management 5.2 Clinical Audits 5.3 The Queensland Health Pap Smear Register
93 99 105 RESOURCES CD - Handbook, PowerPoint presentation and NHMRC Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities CD - Sensitive Examination Technique Cervical Cancer Background Information SECTION 1 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 7 1.1 Cervical Cancer Incidence and Mortality Key concepts the demographics of cervical cancer and cervical screening participation rates recent state, national and world-wide statistics relating to cervical cancer incidence, morbidity and mortality cervical screening participation rates of women in Queensland references for the most current statistics and research regarding cervical cancer. Learning outcomes Participants of cervical screening courses will be able to: describe the cervical cancer incidence and mortality in Queensland, Australia and other parts of the world recognise and explain the overall cervical screening participation rates in Queensland and the need for improvement, particularly among unscreened and under-screened women identify the disproportionate burden of disease experienced by Aboriginal and Torres Strait Islander women in Queensland know the sources of current statistical information relating to cervical cancer incidence and mortality using information technology. Cancer of the cervix is a preventable and curable cancer if detected early. Research suggests that up to 90% of the most common form of cervical cancer, squamous cell carcinoma, can be prevented if women have a regular Pap smear every two years. In Australia about $150 million a year is spent on preventing cervical cancer. Half of this is allocated to screening and early detection activities, and the remainder for investigating and treating women with screen detected abnormalities. The lifetime probability of an Australian woman (to age 75 years) developing cervical cancer is 1 in183. Invasive cervical cancer is virtually unknown in women under the age of 20 and is very rare before the age of 25. Between the ages of 25 and 50 there is a rapid increase in the incidence of invasive cervical cancer. For women of all ages incidence of cervical cancer was highest among women over 75 years with peak incidence of 16.2 per100,000 in the 80-84 age group. SUMMARY INFORMATION Cervical Cancer Background Information SECTION 1 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 9 1.1 Cervical Cancer Incidence and Mortality Cervical Cancer Background Information Cancer of the cervix is the only cancer for which the expected number of new cases in Australia is projected to decrease even with the expected ageing of the population. Squamous cell carcinoma is the most frequent type of cervical malignancy (80-85%) and has decreased in incidence in Australia over the last twenty years. It is most easily detected by the Papanicolaou (Pap) smear. 1 Adenocarcinomas account for the signicant minority of cervical cancers (22.4%). The incidence of adenocarcinoma has remained essentially unchanged since 1990 (2.2 per 100,000 in 2003) 1 and remains an outstanding challenge. The inability to improve the statistics for adenocarcinoma is generally attributed to difculties of sampling glandular lesions in the endocervical canal and difculties in interpretation of cytologic abnormalities where adenocarcinomas arise. 2
Recent state, national and world-wide statistics relating to cervical cancer incidence and mortality. Queensland In Queensland, cervical cancer was the 13th most common cancer diagnosed in women during 2006. In that year 186 Queensland women were diagnosed with cancer of the cervix and 60 women died as a result of this disease. 3 Over the last four available reporting periods (2003, 2004, 2005, 2006) for the Queensland Cervical Screening Program (QCSP) the incidence of cervical cancer was 8.1, 7.4, 8.7 and 9.0 (per 100,000 women) respectively. However SUPPORTING INFORMATION the incidence of cervical cancer in Queensland is higher than all other Australian States and Territories with the exception of the Northern Territory and Western Australia. The reported number of incident cases of cervical cancer in discrete rural and remote Aboriginal and Torres Strait Islander communities in Queensland between 1997 and 2002 was more than twice the expected number for the general Queensland population. The age-standardised mortality rate in the period 2000-2004 was more than four times higher in the Northern Territory, South Australia, Queensland and Western Australia (the only states where Indigenous mortality data is of sufcient quality) then in remaining states. 1 In previous studies, incidence rates were ve time higher and mortality at least 13-fold higher in Aboriginal and Torres Strait islander communities. 4
Mortality due to cervical cancer over the last four available reporting periods (2003, 2004, 2005, 2006) was 2.0, 2.3, 2.0 and 2.7 (per 100,000 women) respectively. 3 In 2006 cervical cancer was the 14 th most common cause of cancer death in Queensland women. 3 Mortality due to cervical cancer in Aboriginal communities was 13.3% higher than the rest of Queensland and in the Torres Strait Islands was 21.5 times higher. 4 Australia The number of new cases of cervical cancer in Australia has continued to decline. There were 734 new cases in Australia in 2006 compared Page 10 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education with 1,072 detected in 1989 prior to the start of the National Cervical Screening Program. Currently Australia has the second lowest incidence rate of cervical cancer (9.1 women per 100,000 women) in the world. 8
Cervical cancer is the 19th most common cause of cancer mortality in Australian women, and accounted for 224 deaths in 2006. The age standardised mortality from cervical cancer halved between 1991 and 2005 from 4.0 deaths per 100,000 to 1.9 per 100,000. During the same period, for women aged 20-69 years, the rate fell from 4.0 per 100,000 to 2.0 per 100,000 women. 1
There are variations in mortality rates from cervical cancer between metropolitan, regional and rural areas within Australia. Although overall death rates from cervical cancer have reduced, higher rates in remote and rural areas are observed. The 2000-2003 age standardised mortality rate was 2.4 per 100,000 for remote areas, 2.5 per 100,000 for regional areas compared with 1.9 per 100,000 in metropolitan areas. 1 The cervical cancer mortality rate in Australia for Aboriginal and Torres Strait Islander women is higher than for non-Indigenous women. During the period 2001-2004 the age standardised mortality rate for cervical cancer for Aboriginal and Torres Strait Islander women aged 20-69 years was more than four times the rate for non-Indigenous women, at 9.9 per 100,000 as compared to 2.1 per 100,000 for non indigenous women. 1 World Wide Cervical cancer has a major impact on womens lives worldwide, particularly in developing countries where it is a leading cause of death among women. 5 The world age-standardised incidence rate of cervical cancer is 16.2 women per 100,000 women and the mortality rate is 9.0 per 100,000. 6 This makes cervical cancer the second most common cancer affecting women after breast cancer and the third most common cause of cancer mortality in women worldwide. The incidence and mortality rates from cervical cancer however vary from country to country. According to the latest global estimates, 493,000 new cases of cervical cancer occur each year among women and 275,000 women die of the disease annually. 6 7 This represents nearly 10% of all cancers in women. Four out of ve new cases, and a similar proportion of deaths, occur in developing countries where screening programs are not established. The hardest-hit regions are among the worlds poorest including Central and South America, the Caribbean and sub-Saharan Africa. Because the disease progresses over many years, an estimated 1.4 million women worldwide are living with cervical cancer, and two to ve times more women (up to 7 million women worldwide) may have precancerous conditions. 5 The lack of effective screening and treatment strategies is a major reason for higher cervical cancer rates in developing countries compared with countries with screening programs. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 11 Cervical Cancer Background Information Cervical Screening Participation in Australia The National Cervical Screening Program was established as a joint initiative of the Commonwealth, State and Territory governments in 1991. Participation in the National Cervical Screening Program is measured by two-year participation rates. In 2006-2007 participation in cervical screening of Australian women aged 20-69 was 61.5%.1 For the rst time in 2005-2007 the Australian Institute of Health and Welfare reported three and ve year participation rates. Nationally the participation rates for women aged 20-69 years were 74% over three years and 86.4% over 5 years. 1
In 2006-2007 two year participation rates by geographical regions were 62.5% for major cities, 61.2% for inner regional, 58.9% for outer regional 53.6% for remote locations and 54% for very remote areas. Cervical Screening participation by women from the highest level of socio-economic status was 71.5% while 57.3% of women from the lowest level of socio-economic status participated in cervical screening. 1 Cervical Screening Participation Rates in Queensland The state-wide participation rate for the target age group of women aged 20 to 69 years in 2006-2007 was 59.3% This is the second lowest participation rate after the Northern Territory and below the Australian rate of 61.5% (2006- 2007). 1 There are several factors that may have contributed to this; The geographical distribution of the population throughout Queensland A rapidly growing Queensland population and subsequent increase in the population of women eligible for screening A shortage of general practitioners(GPs), particularly female GPs in rural and remote areas Decreased numbers of GPs who bulk bill The relatively high number of international medical graduates in rural and remote areas, many of whom are from countries where there is no organised population screening and therefore there are limited opportunities for training. The percentage of women in Queensland who are Aboriginal and Torres Strait Islander women whose uptake rates are low in some areas. Page 12 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education The unscreened and underscreened groups in Queensland reect those identied nationally. The groups that are particularly underscreened are: Women over 50 years of age Women living in rural and remote areas Women from Culturally and Linguistically Diverse backgrounds Aboriginal and Torres Strait Islander women. Cervical Cancer in the future Despite successful screening programs and recently introduced HPV immunisation programs, cervical cancer will continue to exist though it may be classied as a rare cancer. Special care however will need to be taken to ensure that most marginalised and dispossessed women in our society are immunised, screened and treated. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 13 Cervical Cancer Background Information Additional Reading Jelfs P. (1995) Cervical Cancer in Australia. Australian Institute of Health and Welfare. Cancer Series Number 3, Canberra. (Chapter 3). Australian Institute of Health and Welfare (2005) Cancer Incidence Projections Australia 2002 to 2011. Australian Association of Cancer Registries. Cat. No CAN 25 Canberra. (Executive Summary and relevant tables that relate to Incidence and Mortality for cervical cancer). The Cancer Council Australia (2007) National Cancer Prevention Policy 2007-2009. Camperdown NSW. (Document can be downloaded: www.cancer.org.au) Zhang X, Condon J, Denpsey K and Garling L. (2008) Cancer Incidence and Mortality, Northern Territory 1991-2005. Department of Health and Families Darwin. Supporting Material PowerPoint Presentation 1.1: Cervical Screening Presentations: Part 2 Section of the Handbook. References 1. Australian Institute of Health and Welfare (AIHW) (2009) Cervical Screening in Australia 2006-2007, AIHW, Canberra. 2. Mitchell H, Hocking J and Saville M (2003) Improvement in protection against Adenocarcinoma of the Cervix Resulting from Participation in Cervical Screening. Cancer 99: 336-341. 3. Queensland Cancer Registry (2009) Cancer in Queensland, Incidence and Mortality 1982-2006, Queensland. The Cancer Council Queensland, Queensland Health, Brisbane. 4. Coory M, Fagan P Muller J and Dunn N (2002) Participation in cervical cancer screening by women in rural and remote Aboriginal communities in Queensland. Medical Journal of Australia, 177. 544-547 5. Ashford Land Collymore Y (2005) Preventing cervical Cancer Worldwide. Population Reference Bureau. Washington DC, USA. 6. Ferlay J (2002) Cancer Incidence, Mortality and Prevalence Worldwide. GLOBOCAN 2002, Lyon, France. 7. Huh WK, Kendrick JE, Alvares RD (2007) New advances in vaccine technology and improved cervical cancer prevention. Obstetrics and Gynaecology.109: 1187-1192. 8. Australian Government, National Health and Medical Research Council (2005) Screening to prevent cervical cancer: Guidelines for the management of asymptomatic women with screen detected abnormalities. Canberra. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 15 The aetiology of cervical cancer is important in understanding the disease and its prevention. Recent advances in knowledge and understanding of Human papillomavirus (HPV) and its role in cervical abnormalities and cervical cancer have led to a changed understanding of the aetiology of cervical cancer. Key concepts the aetiology of cervical cancer HPV and its role in the development of cervical cancer other risk factors implicated in the development of cervical cancer Learning outcomes Participants of cervical screening courses will be able to: describe the aetiology of cervical cancer discuss HPV and explain the role it plays in the development of cervical cancer list the risk factors for the development of cervical cancer in eligible women. SUMMARY INFORMATION 1.2 The Aetiology of Cervical Cancer Cervical Cancer Background Information Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 17 Cervical Cancer Background Information Human Papillomavirus There is overwhelming evidence that Human papillomavirus (HPV) is necessary for the development of cervical cancer. 1,2,3,4,5 Research using sensitive methods to detect HPV, demonstrate that over 99.7% of cervical cancers test positive for HPV DNA. 6 Furthermore, the National Institute of Health Consensus Conference on Cervical Cancer concluded that cervical cancer is unique in that it is the rst solid tumour to be shown to be virally induced in essentially every case. 7
More than 200 types of HPV have been identied of which almost 40 affect the genital tract. HPV types are classied as high risk (oncogenic) or low risk (non-oncogenic). Only high risk types of HPV have been associated with cervical cancer. There are over 15 high risk genital HPV types however, infection with HPV 16 is responsible for over 50% of cervical cancers and HPV 18 for an additional 20% of cancers. 8,9 Infection with high risk genital HPV is almost always sexually transmitted. 10 Low risk HPV types include types 6 and 11, which are linked to approximately 90% of genital warts cases and around 10% of low grade cervical abnormalities. 9
HPV infection is very common in the early years of a womens sexual activity and is an extremely common infection. 11 The peak prevalence of HPV infection occurs in women in their early 20s. Women have a 50% chance of becoming infected with HPV after one episode of SUPPORTING INFORMATION unprotected sexual intercourse. 11 A productive infection of HPV in the cervix often manifests itself as a low grade squamous intraepithelial lesion (LSIL) but can also lead to high grade squamous changes (HSIL). Cervical cancer however is a rare outcome of HPV infection. The modal age of rst infection (LSIL) with high risk genital HPV is between 15 and 25 years. 12 More than 95% of women who acquire a genital HPV infection clear the infection within 3 years and the median clearance time varies between 8 to 14 months. It is persistent HPV infection that may lead to the development of high-grade abnormalities and infections persisting beyond three years are unlikely to resolve spontaneously, however some women can have HPV infection for a lifetime without developing cervical cancer. 11
It has also been demonstrated that the prevalence of HPV in the community is extremely high, especially among young women; however the modal age of diagnosis with cervical cancer in unscreened women varies between 35 and 50. Less than 0.2% of cervical cancers occur in women under 25 years of age. 11 The lifetime risk of cervical cancer, given infection with high risk HPV, varies across geographical regions from 1 in 15 to 1 in 100. 11 In Australia the lifetime risk of a woman developing cervical cancer is about 1 in183. 12 Whilst persisting infection of the cervix with a high-risk HPV is necessary for the development of cervical cancer, it is not sufcient alone. 10
Other factors have been found to be positively 1.2 The Aetiology of Cervical Cancer Page 18 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education associated with a womens risk of persistent HPV infection and these include smoking (amount, duration and age at which smoking commenced) and immunosuppression. Progression to cervical cancer has been positively associated with age at diagnosis (over 30 years of age) and the size and extent of the cervical lesion. 12,13,14 There is evidence that cervical cancer may progress more rapidly in women infected with HPV if they are also oral contraceptive users. Oral contraceptives have not been found to increase the incidence of preinvasive cervical cancer, however there has been a signicant association found between the use of oral contraceptives and cervical cancer which increases with duration of use suggesting a promoting effect rather than carcinogenic action 15,16,18 . In recent years cervical infection with high risk HPV DNA has been linked to the development of most cervical adenocarcinomas and has been identied in the majority of lesions labelled as adenocarcinoma in situ. Cervical cancer There are two main types of cervical cancer. These are squamous cell carcinoma and adenocarcinoma. The most common form of cervical cancer is squamous cell carcinoma which starts in the squamous cells of the cervix. Adenocarcinoma is much less common and occurs in glandular cells. The Pap smear has lead to a decrease in the number of women with squamous cell cervical cancer, but it is not designed or able to detect glandular changes so the rate of glandular or adenocarcinoma in Australia has not decreased since the introduction of an organised approach to cervical screening. Squamous cell cervical cancers almost always arise in the transformation zone and it is therefore very important cells are taken from the transformation zone during a Pap smear, as this is the region most likely to undergo changes. 15,16 Because the Pap smear is able to detect premalignant squamous cell changes and there is a prolonged time period (approximately 10 years) before the majority of changes progress to invasive cancer, regular two-yearly Pap smears are an effective test for the screening and early detection of cervical abnormalities. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 19 Cervical Cancer Background Information References 1. Hulka B (1982) Risk factors for cervical cancer. Journal of Chronic Diseases 35: 5-11. 2. Villa L (1997) Human Papilloma viruses and cervical cancer. Advances in Cancer Research 71:321-42. 3. Turek L, Smith E (1996) The genetic program of genital human Papilloma viruses in infection and cancer. Obstetrics and Gynaecology Clinics of North America 23(4) 735-58. 4. Park T, Fijiwara Hand Wright T (1995). Molecular biology of cervical cancer and its precursors. Cancer 76: 1902-13. 5. Walboomers J , Meijer C (1997) Do HPV-Negative cervical carcinomas exist. Journal of Pathology 181: 253-54. 6. National Institutes of Health Consensus Development Conference Statement on Cervical Cancer (1997) Gynaecologic Oncology 66:351-61. 7. Bosch F (2000) Clinical cancer and HPV: a worldwide perspective. In: 4th International Multidisciplinary Congress, Eurogin 2000, Paris France. 8. Ho GY, Bierman R, Beardsley L, Chang CJ, and Burk RD (1998) Natural history of cervicovaginal Papillomavirus infection in young women. New England Journal of Medicine 338(7): 423-28. 9. Wain G ( 2008) HPV Vaccines and the Australian Human Papilloma virus(HPV) Vaccination Program. Cancer Forum.32:2;96-98. 10. Fairley CK, Tabrizi SN, McNeil JJ, Chen S, Borg AJ and Garland SM (1993) Is HPV always sexually acquired? Medical Journal of Australia 159(11- 12): 724-26. 11. Frazer I. Presentation at Wartfest on 07/02/2006, at Princess Alexandra Hospital , Brisbane. 12. Schiffman M and Kjaer SK (2003) Chapter 2: Natural History of anogenital human Papillomavirus infection and neoplasia. Journal of the National Cancer Institute Monographs (31):14-19. 13. Thomas D Ray r and World Health Organisation Collaborative Study of Neoplasia and Steroid Contraceptives (1996) American Journal of Epidemiology144(3); 281-89. 14. Australian Government, National Health and Medical Research Council (2005) Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities. Australian Government, National Health and Medical Research Council. Canberra. 15. Hammond I (2006) The Queensland Cervical Screening Program Update. QSCP Queensland Health, Brisbane. 16. International Collaboration of Epidemiological Studies of Cervical Cancer (2007) Comparison of risk factors for invasive squamous cell carcinoma and adenocarcinoma of the cervix: collaborative reanalysis of the individual data on 8,097 women with squamous cell carcinoma and 1,374 women with adenocarcinoma from 12 epidemiological studies. International Cancer Journal February 15; 120(4):885-91. 17. Lalonde ABand Reid R (2008) Position Statement. Birth Control Pill and Cancer. Council of the Society of Obstetricians and Gynaecologists of Canada.Current Opinion in Obstetrics and Gunaecology16:1; 27-29. 18. Hannaford PC, Sivasubramaniam S, Elliott AM, Angus V Ivarsen and L,Lee A J (2007) Cancer risk among users of oral contraceptives: cohort data from the Royal College of General Practitioners contraception study. British Medical Journal Online Page 20 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Additional Readings Commonwealth Department of Health and Family Services (1998) Screening for the Prevention of Cervical Cancer Australian Government, Canberra. National Health and Medical Research Council (2005) Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities Australian Government, Canberra. (Chapter 2) (This document can be sited or downloaded from NHMRC website: http://www.nhmrc.gov.au/ publications/synopses/wh39syn.htm Supporting Material PowerPoint Presentation 1.2: The Aetiology of Cervical Cancer. Part 2 Section of the Handbook CD. Population Screening for Cervical Cancer SECTION 2 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 21 Key concepts population screening in the context of cervical screening the cervical screening pathway the National Cervical Screening Policy Pap smear guidelines for women in special circumstances. Learning outcomes Participants of cervical screening courses will be able to: explain the core components of a screening program outline the principles of cervical screening in the context of population health discuss the role of medical practitioners in the cervical screening pathway identify the cervical screening target group and the frequency of screening according to the National Cervical Screening Policy explain the recommendations for screening women under special circumstances. Signicant reductions in morbidity and mortality from invasive cervical cancer have occurred in countries and communities which have developed an organised approach to cervical screening and have ensured a high proportion of eligible women have been screened regularly. The implementation of an organised, population based cervical screening program in Australia has been a successful public health program that has resulted in signicant reductions in cervical cancer incidence and mortality. SUMMARY INFORMATION Population Screening for Cervical Cancer 2.1 Principles of Population Screening and the National Cervical Screening Program SECTION 2 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 23 2.1 Principles of Population Screening and the National Cervical Screening Program Population Screening for Cervical Cancer Cervical cancer is the second most common cancer among women worldwide, with almost half a million new cases each year. 1 Prevention of cervical cancer centers on screening for abnormalities using the Pap smear, named after Dr George Papanicolaou. Dr Papanicolaou began the study of vaginal cytology in humans in 1920. Upon examination of a slide made from a patients vaginal uid he discovered that abnormal cancer cells could be observed under a microscope. The Pap smear was not accepted by the scientic community until the early 1950s when large scale screening began in America. This resulted in a historic drop in the incidence of cervical cancer among American women. Systematic cervical screening during the 1960s sharply reduced cervical cancer in Iceland and Finland which contrasted to a slow but steady increase of cervical cancer in Norway. 2 In 1990, Miller concluded that screening using the Pap smear plus adequate follow up therapy led to major reductions in cervical cancer incidence and mortality rates. 3
In 1998, the World Health Organization (WHO) published guidelines outlining the essential elements of population screening programs. 4
WHO advised that a number of factors should be taken into account when the adoption of any screening technique is being considered: sensitivity: the effectiveness of a test in detecting a cancer in those who have the disease specicity: the extent to which a test gives negative results in those that are free of the disease positive predictive value: the extent to which subjects have the disease in those that give a positive test result negative predictive value: the extent to which subjects are free of the disease in those that give a negative test result acceptability: the extent to which those for whom the test is designed agree to be tested. 4 In addition WHO outlined that the success of screening programes depends on a number of fundamental principles: the target disease should be a common form of cancer, with high associated morbidity or mortality effective treatment, capable of reducing morbidity and mortality, should be available test procedures should be acceptable, safe, and relatively inexpensive. 4
WHO has identied specic criteria that need to be considered before a screening program is instituted as a part of a national cancer control program: the condition to be detected is of public health importance the natural history of the condition is understood and there is an unsuspected but detectable (pre-clinical) stage SUPPORTING INFORMATION Population Screening for Cervical Cancer Page 24 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education there is an ethical, acceptable, safe and effective procedure for detecting the condition at a sufciently early stage to permit intervention there are ethical, acceptable, safe and effective preventive measures or treatments for the condition when it is detected at an early stage there is sufcient political will, and it is feasible to carry out the relevant screening, diagnostic and intervention practices in a population-based manner with existing resources or with resources that could be obtained during the planning period adoption and implementation of the screening, diagnostic and intervention practices will strengthen the development of the health system and overall societal development in a manner consistent with the principles of primary health care the cost of screening and intervention is warranted and reasonable compared with alternative uses of resources. 4 In October 2008, Australian Health Ministers Advisory Council Screening Subcommittee released Population Based Screening Framework document. 13 The purpose of the document is to inform decision makers on the key issues to be considered when assessing potential screening programs in Australia. The framework is underpinned by the principles of access and equity, fundamental elements to all population screening programs, and is intended to provide guidance and inform judgement. National Cervical Screening Program in Australia The major goals of the National Cervical Screening Program which was introduced in 1991 are to reduce incidence and mortality of cervical cancer in women. Cervical screening using the Pap smear detects abnormalities of the cervix at an early stage and medical intervention can avert the possible progression to cervical cancer. For the National Cervical Screening Program to be successful it is essential that it reaches all women who are eligible. Regular participation in cervical screening is the key to the prevention of cervical cancer and as such is the primary indicator used in monitoring the success of the program. In Australia the Pap smear became available in the 1960s. For more than 20 years screening was provided in an opportunistic manner, without a coherent national approach. Women were frequently provided with inconsistent and conicting messages. This resulted in unnecessary frequent screening of women at low risk, and failure to reach women at high risk. Moreover it was expensive and its effectiveness could not be measured. 5 As a result of the success of an organised approach to cervical screening in Nordic countries, the Australian Health Ministers Advisory Council (AHMAC) commissioned a review of cervical screening in 1988. Subsequent evaluation and pilot projects funded by the Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 25 Population Screening for Cervical Cancer Commonwealth found that Australia was preventing only 50% of all cases of cervical cancer when up to 90% of the most common form a cervical cancer, squamous cell carcinoma was believed possible with a systematic approach. 2 The Commonwealth then established a new program called Organised Approach to the Prevention of Cancer of the Cervix in 1991. 5
In 1995 this was renamed the National Cervical Screening Program which aims to reduce avoidable deaths from cervical cancer by: encouraging women at risk to have a Pap smear every two years improving accessibility and reliability of services for the provision and testing of Pap smears optimising the management of women with screen detected abnormalities improving monitoring and evaluation. Cervical screening in Australia does not operate through a separate dedicated screening and assessment service. Screening services are provided as part of the mainstream health services, with the great majority of Pap smears provided in the general practice setting. The National Cervical Screening Program has national and state and territory components. Although policy is usually decided at the national level, coordination of screening activity happens at the state and territory level. The National Cervical Screening Program has also overseen the establishment of Pap Smear Registers in each state and territory. These are condential databases of Pap smear results for the purposes of issuing reminder letters to women when their Pap smear is overdue and providing a safety net for the follow-up of women with abnormal Pap smears. The registers also provide information to laboratories, in the form of screening histories, to assist in the reporting of current tests, and quantitative data to manage quality assurance activities. The implementation of an organised, population based cervical screening program in Australia is one of the most successful public health programs of its time. 6 It has been estimated that cervical screening saves over 1,200 women from developing cervical cancer each year. 7 The Cervical Screening Pathway The organised approach to cervical screening encompasses more than the provision of Pap smears and is reected in the cervical screening pathway. It is essential that all aspects of the screening pathway are of high quality and function correctly for the population benet of cervical screening to be realised. The interface between screening services and treatment services is critically important and requires a partnership approach between government, non-government and private sector services, to ensure that the desired cancer control outcomes are achieved. 8 Page 26 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Recruitment of Women Community development processes and effective health promotion strategies to recruit unscreened and underscreened women into the cervical screening program. Monitor participation in cervical screening. Screening Intervals Know which women require Pap smears, as set out in the National Policy. Give women information about cervical cancer prevention. Recognise barriers to regular screening. Have a reminder system to ensure women are screened regularly. Inform women about the role and function of the Queensland Health Pap Smear Register Pap Smear Provision Ensure quality of Pap smears provided. Reporting of Pap Smears Ensure feedback and monitoring of Pap smear quality assurance. Follow-up of Results Have an efcient system for notifying results to women, identifying abnormal results and recalling women. Negative Smear Routine screening every two years. Reminder systems. Abnormal Smear Provide information to women. Manage and refer as per guidelines protocols. The steps of the cervical screening pathway are: Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 27 Population Screening for Cervical Cancer Cervical Screening in Special Circumstances Pap smears guidelines for women with special circumstances are included in the NHMRC guidelines: Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities. 9 In these circumstances the interval between Pap smears and recommendations relating to Pap smears differ as these women are not participating in population screening given their risk prole. The National Cervical Screening Policy is a key part of the Cervical Screening Pathway and recommends the following:. Routine screening with Pap smears should be carried out every two years All women aged 20 to 69 years who have ever been sexually active have a Pap smear every two years. Pap smears may cease at the age of 70 years for women who have had two negative Pap smears within the last ve years. Women over 70 years who have never had a Pap smear, or who request a Pap smear, should be screened. This policy applies only to women without symptoms that could be due to cervical pathology. Women with a past history of high grade cervical lesions, or who are being followed up for previous abnormal smears should be managed in accordance with the NHMRC guidelines: Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities. 9
Symptomatic women: it is important to remember that a woman with any abnormal symptoms (irregular bleeding or discharge) does not come under the National Cervical Screening Policy as this only applies to asymptomatic women. In such situations a Pap smear may be collected as part of the investigative workup that could include referral for further investigation. The National Cervical Screening Policy is under consideration in the light of new evidence pertaining to the natural history of human papilloma virus and its role in the development of cervical cancer. Furthermore introduction of the HPV vaccine and new technologies for detecting cervical abnormalities may lead to changes to National Cervical Screening Policy in the near future The National Cervical Screening Policy Page 28 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Cervical Screening in Pregnancy Queensland Health has a Policy and Protocol for Cervical Screening in Pregnancy. It states a Pap smear should be offered to every woman booking for antenatal care who has not had cervical screening within the past two years, and to any woman with a history of abnormal symptoms or treatment of cervical abnormalities who has not been followed up in accordance with national guidelines. It is recommended that Pap smears be offered to women where appropriate to at least 28 weeks of pregnancy and in selected other women into their third trimester, if it appears likely that they may have difculty presenting for screening in the post natal period. Pap smears have not been associated with an increased rate of miscarriage or pre-term labour. If a woman is concerned and is reluctant to agree to have a Pap smear, the provider should emphasise to the woman the importance of having a Pap smear performed at an early date in the post-natal period (no earlier than 12 weeks). It is also recommended that every woman with unexplained bleeding in early pregnancy should have her cervix visualised via a speculum to ensure that unexpected malignancy is not the cause. The Queensland Health has developed a Policy and Protocol for Cervical Screening in pregnancy which can be found on the website www.health.qld.gov.au/cervicalscreening The Policy outlines the Pap smear procedure to follow for a pregnant woman. 6 Cervical Screening after Hysterectomy A hysterectomy is the surgical removal of the uterus. Hysterectomies may be performed because of abnormal bleeding, prolapse, benign tumours such as broids, damage to the uterus during childbirth or surgical procedures, or because of cancer. As well as removing the uterus, the surgeon will usually remove the cervix, and in some cases the ovaries and fallopian tubes. 10 Whether a woman needs to have a Pap smear following hysterectomy depends on: whether she still has a cervix why the hysterectomy has been performed whether the Pap smear was negative before the surgery. When the cervix was removed during the operation, a woman MAY need to have Pap smears from the vault (top) of the vagina if: the hysterectomy was performed because of cancer of the uterus, cervix, ovaries or fallopian tubes, or abnormal cells were found at the time of surgery it is not known why the hysterectomy was performed the woman had abnormal Pap smears in the past the woman did not know if she had previously had abnormal Pap smears Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 29 Population Screening for Cervical Cancer the woman is taking medication which suppresses the immune system, eg cortisone prescribed for asthma or arthritis the woman was exposed to the drug Diethyl- stilboestrol before she was born. If a woman has a subtotal hysterectomy, where the cervix is not removed and is present then the normal screening regime applies. Guidelines for Immunosuppressed Women Immunosuppressed women are at increased risk of developing a persistent productive HPV infection that may develop into cervical cancer. 9
Women may be immunosuppressed because of HIV infection or the effect of drugs, such as those used to prevent rejection of transplanted organs/tissues or the treatment of autoimmune diseases such as systemic lupus erythematosus, ulcerative colitis or asthma. Immunosuppressed women have a 20% increased risk of intraepithelial neoplasia (compared with less than 5% for general population). 9 The management of these women is complex and should be carried out in specialist centres. Guidelines for women exposed in utero to diethylstilboestrol (DES) DES was given to pregnant women between 1940 and 1970 to provide luteal support to those with previous poor pregnancy outcome. 9
Although DES exposure in utero rarely leads to vaginal adenocarcinoma, vaginal adenosis occurs in 45% of these women and structural abnormalities are present in 25%. 11 DES-exposed women should be offered annual cytological screening and colposcopic examination of both the cervix and vagina with a clinician experienced in colposcopy of the lower genital tract. Screening should begin at any time at the womans request and continued indenitely. Symptomatic women It is important to remember that a woman with any abnormal symptoms (irregular bleeding or discharge) does not come under the National Cervical Screening Policy as this only applies to asymptomatic women. In such situations a Pap smear may be taken as part of the investigative workup that would include referral for further investigation. References 1. Ferlay J (2000) GLOBOCAN 2000: Cancer incidence mortality and prevalence worldwide. Lyon. IARC Cancer Base No5. 2. Hakama M (1982) Trends in the incidence of cervical cancer. In Magnus K, ed. Trends in cancer incidence. Washington DC, Hemisphere. 3. Miller (1990) Report of the workshop of the UICC project on evaluation of screening for cancer. International Journal of Cancer 46: 761-69. 4. World Health Organization (2002) National Cancer Control Programmes, Policies and Managerial Guidelines. World Health Organization, Geneva. 5. Australian Health Ministers Advisory Council (AHMAC) (1991) Cervical Cancer Screening Evaluation Committee Cervical Cancer Screening in Australia: Options for Change. Page 30 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Additional Readings Hakama M, Miller AB, Day NE (eds) (1986) Screening for Cancer of Uterine Cervix. International Agency for Research on Cancer, France. Wilson J, Junger G, (1968) Principles and Practice of Screening for Diseases. World Health Organisation, Geneva. (Chapter 2). World Health Organisation (2002) Cervical Cancer Screening in Developing Countries. A Report of WHO Consultation. World Health Organisation, Geneva. (Chapter 2). Commonwealth Department of Health and Family Services (1998) Screening for the Prevention of Cervical Cancer Australian Government, Canberra. Supporting Materials PowerPoint Presentation 2.1: Principals of Population Screening and the National Cervical Screening program .Presentation, Handbook CD Resources that contain Queensland Healths Policy and Protocols for Cervical Screening in Special Circumstances are found on the website www.health.qld.gov.au/cervicalscreening For more detailed information relating to National Cervical Screening Program see Australian Government Department of Health and Ageing website: www.cervicalcreening.gov.au Population Based Screening Framework document: www.cancerscreening.gov.au The Queensland Health Policy and Protocol for Cervical Screening in Pregnancy. This resource can be found on the Queensland Cervical Screening Program website: www.health.qld.gov.au/cervicalscreening 6. Australian Institute of Health: Prevention Program Evaluation Series No.2. QGPS, Canberra. 7. Mitchell HS (2003) How much cervical cancer is being prevented? Medical Journal of Australia, 178-298. 8. Commonwealth Department of Health and Family Services (1998) Screening for the Prevention of Cervical Cancer Australian Government, Canberra. 9. National Health and Medical Research Council (2005) Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities. Australian Government, Canberra. 10. Queensland Cervical Screening Program (2006) Queensland Health Policy and Protocol for Cervical Screening in Pregnancy. Queensland Health , Brisbane. 11. Queensland cervical Screening Program (2000) Are Pap Smears Necessary after Hysterectomy? Queensland Health, Brisbane. 12. Hacker NF (2000) Vaginal Carcinoma In: Practical Gynaecologic Oncology, 3rd Edition Berke JS and Hacker NF (eds.) Lippincott Williams and Wilkins, Philadelphia. 13. Australian Health Ministers Advisory Council Screening Subcommittee (2008) Population Based Screening Framework. Commonwealth of Australia. Health Promotion in the Context of Cervical Cancer SECTION 3 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 31 Health Promotion in the Context of Cervical Screening 3.1 Health Promotion and Cervical Screening Key concepts factors inuencing womens participation in cervical screening key principles of the Ottawa Charter of Health Promotion in the context of cervical screening evidence-based cervical screening health promotion activities for general practice advocacy and networking skills in the promotion of cervical screening in general practice cervical screening practice incentive payments the availability of relevant health promotion resources. Learning outcomes Participants of cervical screening courses will be able to: discuss the barriers affecting womens participation in cervical screening describe the key principles of the Ottawa Charter for Health Promotion and identify cervical screening prevention and education activities identify strategies for promoting participation in cervical screening including opportunistic and systematic cervical screening in medical settings identify and network with other medical practitioners and health care providers in the community who are involved in the provision of information or services relevant to cervical screening. Regular participation in cervical screening is the key to prevention of cervical cancer. In the context of general practice, cervical screening is an important component of the womens health care. Medical practitioners have a signicant health promotion role to play in inuencing a womans decision to participate in cervical screening. This not only requires the clinical knowledge necessary to perform the Pap smear, but also knowledge of cultural, religious, spiritual, economic, geographical and socio- political inuences that can play a part in womens participation in regular screening. SUMMARY INFORMATION SECTION 3 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 33 3.1 Health Promotion and Cervical Screening Health Promotion in the Context of Cervical Screening Health Promotion provides a framework for action in public health practice which recognises that inequalities in health are embedded in the way society lives and works, economically, politically and culturally. It is perhaps best described as a philosophy that supports the development of policy for the planning and delivery of health care services and recognises the importance of looking at health from a holistic perspective. Over the years the concept of public health has changed and expanded as the views of physicians and health planners have widened from an early focus on hygiene to encompass the prevention of disease. 1 Perhaps the most signicant recent evolution in the public health movement was the development of and commitment to the Ottawa Charter for Health Promotion which was developed at an international conference on Health Promotion held in Ottawa, Canada in 1986. The Ottawa Charter denes health promotion as the process of enabling individuals and communities to increase control over the determinants of health and thereby improve their health. 2
To reach a state of complete physical, mental and social well-being, an individual or group must be able to identify and recognise goals that satisfy their needs including coping with the environment. Health is seen as a part of everyday life and not the objective of living. The Ottawa Charter emphasizes the importance of using an all inclusive approach to the planning of public health policies and health promotion practice. The Key Principles of the Ottawa Charter are: build public policies that support health create supportive environments strengthen community action develop personal skills reorient health services. To facilitate effective and efcient health promotion in the ve areas mentioned above, the Charter urges the development and application of advocacy, mediation and enabling skills to ensure that all people are empowered to gain greater control over their lives and subsequently their health. The role of general practitioners in health promotion has been recognised in The Future of general practice. 3 Five specic strategies are proposed to encourage General Practitioners to be more active in health promotion. These strategies are: Supporting opportunistic health promotion which is about identifying risk factors in a patient if they exist, and encouraging preventive action if one is available. As Ellis and Leeder 4 point out the opportunity to introduce appropriate preventive action to 80 million health consultations a year is too good to waste. In the context of cervical screening, the GP can identify women who are unscreened or underscreened and encourage them to participate in cervical screening. SUPPORTING INFORMATION Page 34 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Improving education and information dissemination to general practitioners about health promotion. This relates to the provision of appropriate and relevant information when it becomes available through a variety of sources such as newsletters, conferences, update meetings, publications etc. For example disseminating information to women about cervical screening and the Pap Smear Register. Increasing and improving the use of record systems in general practice for the purpose of health promotion. Recall and reminder systems can be used to encourage womens participation in cervical screening and increase participation rate in screening of eligible women. Making health targets more relevant to general practice. This includes involving general practitioners in local planning and participation in specic health promotion activities. Providing support for general practitioners who want to be involved in population health promotion. This may involve provision of specially designed literature for patients, participation in health promotion campaigns and other relevant activities. For example GP can display and distribute literature about all aspects of cervical screening during an organised cervical screening campaign, or just keep the information in the surgery and distribute it when needed. Strategies for Promoting Participation in Cervical Screening Straton notes four categories of strategies for promoting participation in screening: (i) individual invitations (call and recall) (ii) improvement of opportunistic screening (iii) provision of special/acceptable and accessible screening services (iv) community and media based health education programs. 5 Individual invitation call and recall Approximately 30% of women say that forgetting is one of the main reasons they do not keep up to date with regular smears. 6 Most of these women also believe that Pap smear is worth while yet may require prompting to do so. General Practice has been recognised as a major focal point of screening service in Australia as approximately 80% of Pap smears are provided by GPs. 4 Reminder, call and recall systems set up by individual GPs have been successful in increasing screening rates. 7
There are many systems in place throughout Australia. Some GPs employ direct mail system that targets all eligible women in a specic target population, while others send out individualised invitations using data from electoral rolls, population registers, district registers, registers of cytology or general practice age-sex registers. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 35 Health Promotion in the Context of Cervical Screening Research has shown that GPs who employ a systematic approach within their practices generally were younger, had larger practices, were predominantly rural, employed a Practice Nurse and had a positive attitude towards the efcacy of screening. It has also been found that offering an appointment time when initially inviting women for screening made them more likely to have a smear. 8 The majority of general practices have reminder systems in place to encourage women to have regular Pap smears before their smear is due. These practices do not rely on the Pap Smear Register to remind women when they are overdue but use this as a back-up. Setting up a reminder service is not difcult. The RACGP patient record system has the provision for recording recall dates on the cover of womens le. There are also software programs which can assist in this. 8 Improving opportunistic screening Opportunistic prevention (screening) is dened as the identication of risk factors and the provision of an appropriate intervention during any medically related consultation, regardless of presenting symptoms. 9 There are limitations to opportunistic screening. The greatest limitation with relying on opportunistic screening is that only women who visit the health service have their screening history assessed. Usually those least likely to attend the practice are those that are least likely to be screened. 10
Recommended steps to encourage cervical screening have been developed from published accounts of the success of the opportunistic approach in general practice. 11 The steps are: identify women at risk opportunistically check what the woman understands offer a Pap smear during the consultation or make another appointment offer written information or recommend a website. Providing special/acceptable and accessible services to women One of the most important components of successful cervical screening is providing women with acceptable and accessible services. 5 This includes the provision of accessible services in a variety of settings to promote access eg GP practice, hospital and special womens health clinics in rural and remote settings. Registered Nurse Pap Smear Providers For some time registered nurses have made a signicant contribution to the Queensland Cervical Screening Program. 12 They have been recognised as an important complementary service provider especially for their role in accessing women who have never had a Pap smear or who do not have regular Pap smears. Registered nurses have consistently demonstrated that they provide accessible, high quality services that women are highly satised with. 13 Queensland Registered Nurse Pap Smear Providers (RN PSP) undertake Page 36 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education specic training in cervical screening that is accredited with the Royal College of Nursing Australia Inc and are deemed competent in meeting the National Standards for Nurse Pap Smear Providers. 14 RN PSPs presently practice in a variety of settings and include, Mobile Womens Health Nurses, Sexual Health Nurses, Remote Area Nurses, Practice Nurses and nurses working in organisations such as Family Planning Queensland, community-controlled Aboriginal and Torres Strait Islander medical services and the Department of Defence Medical centres. Practice Nurse Pap Smear Providers In January 2005, Medicare Item Numbers 10998/9 were issued for cervical screening consultations provided by Practice Nurses (PNs) in regional and remote areas, provided the PN has completed an accredited program. This action has provided the opportunity for RNs working in General Practice to provide cervical screening services for women attending General Practice. The benets of a Practice Nurse providing Pap smears in general practice include: increased access to female Pap smear providers increased capacity of General Practice to offer cervical screening increased capacity to establish and monitor recall and reminder systems increased capacity for general practitioners to offer consultations for clients with complex health needs. Community Based Media and Health Education Programs Community and media based programs have been an integral part of raising the prole of cervical cancer on the public health agenda. Television and radio have been the most popular and thoroughly evaluated media and have the potential to reach large numbers of women as well as target specic groups. 15 Greater longevity of the message is achieved through the use of written material, such as newspapers and magazine articles. Community development strategies such as Pap smear clinics, educational talks, morning teas, distribution of brochures, posters, reminder cards and other relevant information are some of the strategies that can be used to increase participation. 16 Cervical Screening Practice Incentives In 2001-2002 the Australian Government Federal provided money over four years to increase cervical screening participation rates and improve the early detection of cervical abnormalities, thereby aiming to reduce deaths from cervical cancer. The implementation of this initiative supports and builds on the existing National Cervical Screening Program (NCSP) by recognising the role of general practitioners as the primary providers of cervical screening as well as targeting higher risk groups of women. Funding has continued beyond 2005 following an evaluation of the Cervical Screening Practice Incentive payments (PIP). Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 37 Health Promotion in the Context of Cervical Screening The Cervical Screening Incentive has three components: 1. Sign On Component (Practice Incentive Payment -PIP) To be eligible for the sign on payment, PIP practices are required to register for the Cervical Screening Incentive. The sign on payment recognises that practices may incur up-front costs in terms of both time and resources in preparing for the cervical screening incentive. In signing on practices agree: to participate in the cervical screening incentive scheme to have practice details provided to the State/Territory Cervical Screening Registers to receive information from the Registers and consider strategies they propose to improve the level and quality of participation in the NCSP, and that the State/Territory Cervical Screening Registers can provide information about the aggregate number of women screened in the practice to HIC for the calculation of the outcome incentive payment. 2. Service Incentive Payment (SIP-Cervical) GPs working in PIP practices receive a service incentive payment (SIP-Cervical) for screening women between 20 and 69 years who have not had a Pap smear within the last four years as these women are classied as high risk. 3. Outcomes Component A further payment through the PIP is made to practices that reach target levels of cervical screening for their female clients aged 20 to 69. In May 2006, 91.7% of practices in Australia were signed on to participate in these activities (Medicare Australia 2006). Further information about practice incentive payments can be obtained from the PIP enquiry line on 1800 222 032 or via http://www.medicareaustralia.gov.au. The Medical Benets Scheme (MBS Items) MBS items (10994 and 10995) apply to Pap smear and preventive checks provided by a practice nurse on behalf of general practitioner. Item number 10994 can be used by all practices and applies to female patients of any age, while item number 10995 is available only to GPs participating in the Practice Incentive Program (PIP) and generates a Service Incentive Payment (SIP). Item 10995 applies when a Pap smear is provided from a woman between the ages 20-69 who has not had a Pap smear in the last four years. MBS item numbers (10998, 10999) apply to Pap smears provided by Practice Nurses in regional, rural and remote areas. Both items are for Pap smears provided by the Practice Nurse on behalf of a GP. Item 10998 applies to a Practice Nurse who provides a Pap smear for a woman on behalf of the GP, while item number 10999 Page 38 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education References 1. Ferlay J (2000) GLOBOCAN 2000: Cancer incidence mortality and prevalence worldwide. Lyon. IARC CancerBase No5 2. Hakama M (1982) Trends in the incidence of cervical cancer.In Magnus K, ed. Trends in cancer incidence. Washington DC, Hemisphere. 3. Miller (1990) Report of the workshop of the UICC project on evaluation of screening for cancer. International Journal of Cancer 46: 761-69. 4. National Cancer Control Programmes, Policies and managerial guidelines (2002). World Health Organization, Geneva. 5. Straton, JAY (1994) Recruitment for Cervical Screening: a review of literature. Australian Government Publishing Service, Canberra 6. Australian Health MinistersAdvisory Council (AHMAC) (1991) Cervical Cancer Screening Evaluation Committee Cervical Cancer Screening in Australia: Options for Change. Australian Institute of Health: Prevention Program Evaluation Series No.2. QGPS, Canberra 7. Jelfs P (1995) Cervical Cancer in Australia. Australian Institute of Health and Welfare: Cancer Series No3. AIHW, Canberra. 8. Pritchard DA,Straton JAY, LeSeur H, Hyndman J(1994) Cervical Screening in general practice. Department of General Practice University of WA. 9. Stott N ,and Davis R (1979) The exceptional potential in each primary care consultation. Journal Royal College of General Practice. 29:201-05 applies when a Pap smear is provided by a Practice Nurse for a woman who has not had a Pap smear in the last four years and is between 20 and 69 years old. In order to be eligible for claims there are conditions attached. These conditions relate to qualications and training, quality assurance and medical indemnity. In addition Pap smears provided by a Practice Nurse on behalf of a GP count towards the PIP practices outcome component. Further information is available by calling 13 21 50 or the Medicare Australia website: http://www.medicareaustralia.gov.au/ medicareinitiatives Availability of Health Promotion Resources The National and Queensland Cervical Screening Programs produce and publish cervical screening resources for women and health professionals. These resources can be viewed on the Queensland Cervical Screening Program website www.health.qld.gov.au/cervicalscreening. They can be downloaded or ordered directly from the website free of charge. Cancer Council Queensland also has literature for women and those affected by cervical cancer. This information can be obtained by telephoning the HelpLine on 13 11 20 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 39 Health Promotion in the Context of Cervical Screening 10. Shelley J. (1992) Encouraging women to participate in Pap smear screening. Campaign Unit, Commonwealth Department of Health Housing and Community Services. Canberra. 11. Brett T (1992) Opportunistic cervical screening among 50-70 year olds: a prospective study in general practice. Australian Family Physician 21: 1781-84. 12. Cancer Screening Services Unit, Population Health Branch (2008) Queensland Cervical Screening Program Phase 4 State Plan 2007- 2011. Queensland Health, Brisbane 13. Kirk M, Hoban E, Dunne A and Manderson L (1998) Barriers to and Appropriate Delivery Systems for Cervical Cancer Screening in Indigenous Communities in Queensland. Australian Centre for International and Tropical Health and Nutrition., University of Queensland, Brisbane. 14. Commonwealth Department of Health and Community Services (1997) Standards of Practice in Making Quality Visible National Standards for Nurse Pap Smear Providers. 15. Mitchell H (1993) Pap smears collected by nurse practitioners: comparison to smears collected by medical practitioners. Oncology Nursing Forum 20(5): 807-810. 16. Byles J, Sanson-Fisher R (1996) Mass mailing campaign to promote screening for cervical cancer: do they work, and do they continue to work? Australian and New Zealand Journal of Public Health 20(3): 254-60. 17. Byrnes P,McGoldrick C,Crard and M,Peers M (2007) Cervical Screening in General Practice. Strategies for improving participation. Australian Family Physician 36: 3;183-192. Additional Readings The Cancer Council Australia 2007. National Cancer Prevention Policy 2007-09. NSW: The Cancer Council Australia. Straton JAY (1996) Recruitment for cervical screening. A review of the literature. National Cervical Screening Program. Australian Government Publishing Service (Refer to pages 4-29). Womens Cancer Screening Services (2002) Queensland Cervical Screening Program Phase 3, State Plan 2002-2006 Queensland Health, Queensland. OConnor, M.L, and Parker, E. (1995) Health promotion, principles and practice in the Australian context. Allen and Unwin Pty Ltd. St Leonards, NSW 2065 Australia (Chapter 1 and Chapter 10). Egger, G., Spark, R., Donovan ,R., (1999) Health promotion strategies and methods. Second Edition. The Mc Graw- Hill Companies Sydney Australia. (Chapters 1 and 2). Nutbeam D, Harris E. (2004) A practical guide to health promotion theories. McGraw-Hill Sydney Australia Pty Ltd. (Chapters 3, 5 and 6). Page 40 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Supporting Materials PowerPoint Presentation 3:2 Cervical Screening Presentations Part 2 Section of the Handbook CD. Pap Smear Prompt and Reminder Cards. The Queensland Cervical Screening Program produces Pap smear prompt and reminder cards which are available free of charge. These can be ordered directly from the website: www.health.qld.gov.au/ cervicalscreening. This resource can be used in two ways, rstly it can be given to women at the time of the Pap smear to identify the month and year that their next Pap smear is due. Alternately, it can be given as a prompt card to encourage and remind women who are identied as being due for a Pap smear and choose not to have the test performed at the time to make an appointment to have a Pap smear performed. Similar prompt cards and fridge magnets have been developed for Aboriginal and Torres Strait women. r Providers of Medical Practitioner Education Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 41 There are numerous barriers to regular participation in cervical screening that have been identied in the literature. Many of these barriers are complex and interrelated. Appreciation of the complexity of these barriers is important as it can lead to the provision of appropriate services and thus increase the rate of participation of eligible women in cervical screening. Key concepts cervical screening participation rates barriers affecting womens participation in cervical screening cervical screening for women with special needs including lesbian women , women with disabilities, Aboriginal and Torres Strait Islander women and women from culturally and linguistically diverse backgrounds (CALD). Learning outcomes Participants of cervical screening courses will be able to: know the cervical screening participation rates and know how to access them discuss the invasive and sensitive nature of cervical screening and gynaecological examination understand that cervical screening is an invasive and sensitive gynaecological examination identify factors and barriers affecting womens participation in cervical screening describe and understand the complexities and interactions that relate to the barriers to cervical screening. SUMMARY INFORMATION 3.2 Barriers Affecting Womens Participation in Regular Cervical Screening Health Promotion in the Context of Cervical Screening Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 43 Cervical Cancer Background Information Cervical Screening Participation Rates It is essential for the success of the National Cervical Screening Program that it reaches all women who are eligible. Regular participation in cervical screening is the key to the prevention of cervical cancer and as such is the primary indicator used in monitoring the success of the program. The current policy is that women should participate in screening once every two years, and participation is measured by rates. The participation rate in Queensland is calculated as a count of the participation of eligible women aged 20 to 69 who have had a Pap smear within a two-year period and who choose to be registered on the Queensland Health Pap Smear Register (PSR) as a proportion of the eligible population. Women who choose not to have their details sent or who choose to have their details removed from PSR are unable to be counted and therefore, are excluded from the rate. In Queensland the state-wide participation rate for the target age group of women aged 20 to 69 years in 2006-2007 was 59.3%. This is the second lowest participation rate of all the States and Territories and below the latest available Australian rate of 60.6% (2005/2006). 1
The Queensland Cervical Screening Program provides annual participation rates by Queensland Health Service Districts, statistical local areas and general practice divisions. These reports are available on the website: http://www.health.qld.gov.au/cervicalscreening/ health_professionals/stat_info.asp Barriers Affecting Womens Participation in Cervical Screening A review of the literature indicates numerous barriers to cervical screening. 2 Many of the identied barriers are complex and inter-related: Lauver 3 identied three types of barriers to cervical screening participation these were: (1) practitioner related barriers (2) system related barriers (3) client related barriers. 1. Practitioner related barriers These barriers include concerns about client embarrassment, lack of time and lack of discussion about screening between practitioner and client. General practitioners are well placed to provide cervical screening to clients in terms of their large female client base, however barriers are reected by ndings such as those documented by Cockburn et al. 4
These authors state, One of the disappointing ndings of the study, therefore, is the number of GPs who apparently take few smears or none at all. This nding is reinforced by Bowman, Redman, Reid and Sanson-Fisher who state, While general practitioners perceive themselves as the most appropriate providers of cervical screening, some currently are providing a less- than-adequate service to their patients. 5 Time and the pressures to restrict the duration of consultations are listed as signicant barriers to opportunistic screening in general practice. 6
Gender of the practitioner has also been identied as a practitioner related barrier. Studies have indicated that many women SUPPORTING INFORMATION 3.2 Barriers Affecting Womens Participation in Regular Cervical Screening Page 44 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education prefer a female practitioner to provide cervical screening. 6,7,8 This is particularly relevant for Aboriginal and Torres Strait Islander women and women from CALD. 8,9
Other practitioner related barriers identied include qualications of the practitioner, time available, interpersonal skills, comfort levels and knowledge. 10 2. System related barriers These include barriers such as accessibility of services in relation to location (the service is hard to get to), timing (many women work or care for children during ofce hours when most services are offered) and cost to the client of screening tests. Other identied system related barriers include the presence or absence of reminder systems and bulk billing. 10 The introduction of Registered Nurse Pap Smear Providers (RN PSPs) is one strategy aimed at improving the acceptability and accessibility of services. RN PSPs as mentioned in Section 3.1 have been described as providing accessible services especially to at risk groups, including remote, older and CALD women. 11 However, there appears to be a need for greater promotion of the role as identied in a cross-sectional survey of clients attending a large metropolitan Family Planning Clinic in Queensland highlighting a lack of awareness and uncertainty about the role of RN PSPs. 12 3. Client-related barriers These are associated with psycho social factors such as beliefs, norms and affect regarding screening. 3 Client related barriers have been specically identied for Australian women and were described under three broad categories by the Cervical Cancer Screening Evaluation Steering Committee. These were: womens knowledge, attitudes and beliefs about cervical screening womens perceptions of Pap smear services other reasons, such as forgetting or inadequate time. 13 In Australia, surveys have shown that ...while many women have a favourable attitude towards screening, many perceive the test to be embarrassing, uncomfortable, painful or anxiety provoking. 14
External factors such as the media, mixed messages and guilt may also impact on a womans attitude towards a screening program. 15 Cockburn 14 surveyed older women (aged 40 years and over) to explore barriers to screening and found two major barriers were anticipated, embarrassment and the perception that they were too busy. This was a recurring theme in the literature with Jirojwong, Maclennan and Manderson nding; embarrassment and fear of the diagnosis inhibited regular screening among Thai women in Brisbane. 16 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 45 Health Promotion in the Context of Cervical Screening Fear was identied by Seamark as an additional factor impacting on why women do not participate in cervical screening programs. 17 He describes fear from two perspectives. The rst is fear of the actual test that it may hurt or be embarrassing, the second is fear of the result and the lurking possibility of cancer. This was also the nding from a Scottish study of womens views of the Pap smear. 7
Cockburn found that lack of knowledge of cervical screening frequency and purpose is a signicant barrier for older women who often perceived the test to be for cancer and as they were asymptomatic, they did not believe the test was needed. 14 Cultural factors may play some part in this misunderstanding. The link between cervical cancer and HPV, a sexually transmitted infection may also increase resistance to screening. 17 Research conducted in the United Kingdom revealed that thirty-eight women (sixty-two percent of the sample) refused a Pap smear for inappropriate reasons. 18 The reasons cited included: had lived with same partner throughout adult life were not the type of woman to get this disease had not had intercourse for many years. Other client-related barriers which have been identied include issues such as the availability of child care and access to a female practitioner. 7, 8, 17, 19
Another important predictor of cervical screening behaviour is regularity and consistency of care. 20,21 In their study of sociodemographic predictors among White, Black and Hispanic women, Selvin and Brett stress the importance of targeting preventive care messages directly at women who do not have a regular source of care. Often these women do not attend for preventive care because they do not feel unwell and in some cases are unaware of screening procedures and programs. Cervical Screening and Women from Culturally and Linguistically Diverse (CALD) Backgrounds It needs to be realised that the concept of screening is often outside the traditional views of healing and health beliefs of women from many cultures. 18, 22 Poor understanding of or confusion about the Pap smear procedure among women from CALD backgrounds are potential obstacles to cervical screening. Because cancer is viewed in some cultures as a predestined and probably incurable disease, some women typically do not wish to know if they have cancer and are reluctant to discuss the topic. 2
Some believe that only God can save them from cancer and that cancer can be induced by talking or thinking about it. 24 Ansell, Lacey and Whitman argue that if access is difcult or restricted, participation in screening by CALD women is adversely affected. Further, familiarity with the medical system is a strong predictor of participation in cervical screening. 25 Page 46 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education As CALD women represent a diversity of cultures and beliefs, the most acceptable organised attempts to recruit CALD women involve the use of female Pap smear providers and bilingual educators who have received support from their community through a process of active networking and consultation. 26 Aboriginal and Torres Strait Islander Women Aboriginal and Torres Strait Islander women experience a higher incidence and mortality from cervical cancer than other Australian women especially if they live in rural and remote communities. 27 It has been suggested that it is due to several causes: poor socio-economic conditions late presentation of cervical cancer and its precursors lack of adequate medical services and personnel particularly in rural and remote areas a general lack of awareness of preventive behaviour such as screening that can reduce the risk of developing cervical cancer the presence of co-morbidities may predict poorer treatment outcomes in respect to cancer treatment and survival. 28 Aboriginal and Torres Strait Islander women have been shown to share many concerns of non-Indigenous women about Pap smears, such as shyness and lack of knowledge about Pap smears. Studies have shown that Aboriginal and Torres Strait Islander women also have culturally specic beliefs about their anatomy, the function of screening and their approach to health and prevention of illness. 27 The specic beliefs which are considered as barriers to screening among Aboriginal and Torres Strait Islander women are: cervical screening is womens business and should not be discussed with others Pap smears should be performed by women providers the association between cervical cancer and sexually transmitted infections adds to the stigma of screening and shame - in small communities, a woman with cervical cancer may be shunned or rejected women often have pre-existing health problems such as diabetes and renal disease and screening is not of high priority. It has been shown however that most barriers to screening can be overcome by the development and implementation of culturally appropriate screening programs involving trained staff who acknowledge the existence of barriers mentioned above. The provision of special clinics and mobile screening clinics staffed with female Pap smear providers and Aboriginal and Torres Strait Islander liaison ofcers/health workers are essential in increasing the participation of Aboriginal and Torres Strait Islander women in cervical screening. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 47 Health Promotion in the Context of Cervical Screening Women with Special Needs A key factor in reducing mortality from cervical cancer is to recruit all eligible women into the cervical screening program. To maximise recruitment, it is important to accommodate women with special needs including lesbian women and women with disabilities. For women with special needs, physical access to general practitioners including distance from the surgery, lack of female Pap smear providers, poor transport, lack of child care, difculties getting time off work and nancial problems are just as relevant and may be even more so. Depending on the nature of the disability however, cervical screening may be difcult to perform in general practice consulting rooms. It is important to know that some women with upper motor neurone lesions may be at increased risk for autonomic hyperreexia during pelvic examinations. Special guidelines have been published to assist in the provision of Pap smears for women with disabilities. 19 Research has shown that lesbians are less likely to have regular Pap smears than heterosexual women. Many health care providers and patients share the false assumption that because lesbians are not currently sexually active with men, they are not at risk for developing cervical cancer. As a result of this misinformation, lesbians may avoid medical services and health care providers may give incorrect advice so that lesbian women are under screened. However, lesbians, like all women, need regular Pap smears if they have been exposed to risks associated with acquiring HPV. 29
Suggestions for general practitioners to improve the screening rates of women with special needs: remain vigilant and offer cervical screening to women with special needs explain the importance of Pap smears and what is involved in the procedure ascertain whether the woman is comfortable with the setting where a Pap smear is provided and with the Pap smear provider make arrangements for informing the woman of her results and what they mean in a way that they can understand provide information on diagnosis and management options if they arise in relevant ways. Page 48 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education References 1. National Cervical Screening Program (2005) Cervical Screening in Australia. Australian Government, Cat No. CAN 26 Australian Institute of Health and Welfare. Canberra. 2. Forbes, C., Jepson, R., Martin-Hirsch, P (2004) Interventions targeted at women to encourage the uptake of cervical screening (Review): The Cochrane Collaboration. John Wiley & Sons, Ltd. 3. Lauver DR and Kane J (1992) A Motivational Message, External Barriers. Cancer Detection and Prevention 23 (3) 254-264. 4. Cockburn J, White V Hirst S and Hill D (1992) Barriers to Cervical Screening in Older Women Australian Family Physician 21: 973-78. 5. Byles JE, Redman S, Sanson Fisher R and Boyle C (1995) Effectiveness of two Direct-mail Strategies to Encourage Women to Have Cervical (Pap) Smears. Health Promotion International 10: 5-16. 6. Heywood A, Firman D & Ring I (1996) Factors Associated with Pap Smear Taking in General Practice: Focusing Public Health Initiatives. Australian & New Zealand Journal of Public Health 20(3): 260-265. 7. McKie L (1993) Womens views of the cervical smear test: implications for nursing practice women who have not had a smear test. Journal of Advanced Nursing 18: 972-979. 8. Mak D (1997) Why do(nt) aboriginal women have Pap smears? Australian Family Physician 26(6): 763. 9. Kirk M, Hoban E, Dunne A and Manderson L (1998) Barriers to, and appropriate delivery systems for, cervical cancer screening in Indigenous communities in Queensland. A report to Queensland Health. Queensland Health Department. 10. Bell J & Ward J (1998) Cervical screening: linking practice, policy and research in womens health. Cancer Forum 22: 6-11. 11. Womens Cancer Screening Services (2002) Queensland Cervical Cancer Screening State Plan 2002-2006. Queensland Health, Queensland. 12. Christie, L., Gamble, J and Creedy, DK (2005) Womens views of registered nurses on Papanicolau Smear providers: A pilot study. Contemporary Nurse 20 (2) 159-168. 13. Commonwealth Department of Human Services and Health, (1995) Report of the Evaluation of Steering Committee. The Interim Evaluation of the Organised Approach to Preventing Cancer of the Cervix 1991-1995. Australian Government Printing Service, Canberra. 14. Hill D, White V, Borland R & Cockburn J (1991) Cancer-related beliefs and behaviours in Australia. Australian Journal of Public Health 15(1): 14-23. 15. Harokopos, V., McDermott, R (1996) Cervical Cancer Screening: Benets and Barriers. Journal of Health Education 27(6) 351-6. 16. Jirojwong, S., Maclennan, R., Manderson, L (2001) Health Beliefs & Pap Smears among Thai women in Brisbane, Australia. Asia-Pacic Journal of Public Health 13 (1)20-23. 17. Seamark C (1996) Why women do not present for cervical smears - observations from general practice. The British Journal of Family Planning 22: 50-52. 18. Doyle Y (1991) A survey of cervical screening in London District, including reasons for non attendance, ethnic responses and views on the quality of service. Social Sciences and Medicine. 19. NSW Cervical Screening Program (2003) Preventative Womens Health Care for Women with Disabilities. Guidelines for General Practice. Sydney. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 49 Health Promotion in the Context of Cervical Screening 20. Selvin E., Brett, M (2003) Breast and Cervical Cancer Screening: Socio-demographic Predictors among White, Black and Hispanic Women. American Journal of Public Health 93 (4) 618-23. 21. Brett T (1992) Opportunistic cervical screening among 50-70 Year Olds: a Prospective Study in General Practice. Australian Family Physician 21: 1781-84. 22. Hoare T (1996) Breast screening and ethnic minorities. British Journal of Cancer 74: S38- S41. 23. Ling G et al (1996) Reducing the incidence and mortality from cervical cancer. Medical Journal of Australia 164(5): 318-19. 24. Gifford SM (1991) Culture and the provision of preventive health care: Implication for medical education. Cancer Forum 15: 73-80. 25. Ansell D, Lacey L Whitman S, Chen E and Phillips CA (1994) Nurse delivered intervention to reduce barriers to breast and cervical screening in Chicago inner city clinics. Public Health Reports 109: 104-111. 26. Wilcox LS and Mosher WD (1993) Factors associated with obtaining Health Screening among women of reproductive age. Public Health Reports 108: 76-86. 27. Jelfs P (1995) Cervical Cancer in Australia. Australian Institute of Health and Welfare Cancer Series Number 3, Australian Government Publishing Service, Canberra. 28. Valery P, Coory M, Stirling J & Green A (2006) Cancer diagnosis, treatment, and survival in Indigenous and non-Indigenous Australians: A matched cohort study. The Lancet 367, 1842-1848. 29. Rankow ET and Tossaro T (1998) Cervical cancer risk and Papanicolaou screening in sample of lesbian and bisexual women. Journal of Family Practice 47(2): 139-43. Additional Readings Royal College of Obstetricians and Gynaecologists (2002) Gynaecological Examinations: Guidelines for Specialised Practice. London. (This resource can be viewed and downloaded from the website, www. rcog.org.uk). Hill D, Borland R & Cockburn J (1991) Cancer-related beliefs and behaviours in Australia. Australian Journal of Public Health 15(1): 14-23. Straton J (1994) Recruitment for Cervical Screening. A review of literature. National Cervical Screening Program, Australian Government Publishing Service, Canberra. Supporting Materials PowerPoint Presentation 3:2 Barriers Affecting Womens participation in Cervical Screening: Part 2 Section of the Handbook CD. Clinical Skills SECTION 4 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 51 4.1 Communication skills involved in performing sensitive gynaecological examinations Key concepts communication skills involved in performing sensitive gynaecological procedures appropriate communication of issues regarding decision making relevant to cervical screening sensitive communication of abnormal Pap smear results to a woman who has undergone cervical screening. Learning outcomes Participants of cervical screening courses will: explain the procedure and its purpose and limitations to a woman discuss the cultural, social, psychological and emotional factors involved in a womans choice to have a Pap smear perform a Pap smear with sensitivity and care, providing a positive experience for the woman that allows her to understand the process and procedure obtain consent at all stages of the consultation offer a chaperone or companion for the woman communicate Pap smear results effectively and sensitively describe the sensitive issues that surround communication of abnormal Pap smear results to a woman. The Pap smear is a sensitive gynaecological examination, therefore it is important to ensure that women participating in cervical screening are physically and psychologically comfortable during the procedure. This information requires the use of appropriate interaction and communication skills which include cultural and language awareness as well as sensitivity to possible barriers to screening that may be present. Clear information in a format most accessible for the woman herself should be provided to convey what the woman needs to do and what will occur before, during and after the procedure. Communicating Pap smear results, especially abnormal results also requires specic skills and sensitivities to ensure effective communication occurs. The importance of obtaining consent at all stages in the consultation and offering the presence of a chaperone if relevant, contributes to the empowerment of the woman. Clinical Skills SUMMARY INFORMATION SECTION 4 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 53 4.1 Communication skills involved in performing sensitive gynaecological examinations Clinical Skills SUPPORTING INFORMATION Communication at the Time of the Pap Smear The Pap smear has been described as an intimate sensitive examination which involves invasion of personal space. Embarrassment has been shown to be a signicant barrier that discourages women from having a Pap smear. The procedure produces anxiety as it is physically uncomfortable and the examination position itself has been described as imposing directly upon traditional values such as modesty and respectability irrespective of culture, colour or creed. 1 The way that the Pap smear provider communicates with a woman has an inuence on how she feels about the procedure and whether she is likely to return for regular Pap smears. The following communication strategies may assist in ensuring the woman feels safe and does not experience pain during the procedure: Commence the consultation with a warm personal greeting before the examination begins to put the woman at ease and reduce anxiety. The woman should be invited to describe whether she has had a previous Pap smear and any concerns relating to the examination. Explore previous Pap smear experiences and if a woman expresses concerns these should be discussed further prior to commencing the examination. The Pap smear provider should describe the benets of regular cervical screening including that it is a preventive measure to detect changes in the cervix that if detected early can be treated before developing into cervical cancer. The Pap Smear Register should also be discussed at this time to ensure women are aware their results will be forwarded automatically to the register (unless she chooses to opt-off at this stage). The woman also should be advised of the limitations of the Pap smear, the benets of participating in regular cervical screening and the importance of returning if she experiences any abnormal symptoms such as abnormal bleeding. The Pap smear provider should offer to explain the procedure to a woman prior to commencing the examination. Anatomical models or diagrams are useful for this and showing women the specimen collection devices and speculum can also reduce anxiety. This also enables the Pap smear provider to ascertain the level of a womans understanding of the procedure. The woman should be advised that the procedure can be stopped at any stage at her request. Empowering a woman with a stop signal can signicantly reduce anxiety and discomfort as women who are tense tend to tighten their pelvic muscles which can also make the procedure more difcult. This can assist in reducing a womans vulnerability Page 54 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education A tissue should be offered at the end of the procedure to wipe away any lubricant and a place to dispose of it should be provided close to the examination couch. A panty liner or pad should also be available in case she experiences spotting. Further discussion of any abnormality that might have been observed, when the result will be available and how this can be obtained should be discussed after the woman is dressed and has returned to the consulting desk. If there is a language or a cultural barrier it may be necessary to determine the womans literacy and cultural values and if needed use the services of a translator/interpreter (Telephone Interpreter Service 13 14 50) or an appropriate community health worker in the area. Communication of Pap Smear Results The initial communication of an abnormal result is likely to create anxiety and in some women a desire for more information. Many women respond to the identication of an abnormality on their Pap smear by concluding they have cancer, rather than a treatable pre-cursor lesion. 2
About 18% of women with an abnormal result reported in one study that they did not know what the result meant. 3 and fear during the procedure. It is also important to warn a woman about visceral sensations she may experience during the procedure and that she may experience spotting after the procedure. The woman should be offered a chaperone or accompanying person to be present if she wishes. The issue of chaperones needs to be considered in the context of protection of the doctor-patient relationship. Chaperoning can be considered a risk management strategy as it may protect the doctor from allegations of inappropriate behaviour and misconduct, or from misconduct by the patient.2,3. Some hospitals have a policy regarding presence of chaperone during gynaecological examinations. Consent to proceed with the examination should be requested before the woman undresses and once she is lying on the couch. It is important that privacy is maintained at all times. The examination should be performed in a private room and a curtain should be available to allow the woman to undress and position herself on the examination table. A covering sheet should also be provided and clear directions about what clothing to remove should be discussed. Some women prefer to be involved in the process and nd the offer of a mirror to be able to see the cervix empowering. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 55 Human Papillomavirus When discussing abnormal Pap smear results with a woman it is necessary to discuss HPV. It has been demonstrated that some women do not associate cervical cancer with HPV and have low levels of awareness about this virus. It has been shown, that some women experience a range of negative emotions when told they have HPV so this subject needs to be addressed with sensitivity and tact, especially as HPV is a sexually transmitted infection. 4 Women who have been diagnosed with HPV have been found to experience: a negative impact on well-being anxiety, worry, upset, shock, distrust, fear of cancer, guilt/blame intrusive thoughts, somatic symptoms, stigma relating to having a sexually transmitted infection (STI), disclosure concerns concerns about transmission or reinfection by partner. 4 The key information that women want to know about HPV includes: HPV viral types avoid the use of the word warts when discussing HPV implications for sexual relationship prevalence, latency, regression treatment and management implications for cancer risk and fertility. 4 The National Cervical Screening Program has produced a brochure for women: The link between Cervical Cancer and HPV that can be used to assist with communicating these issues to women. It has also been demonstrated that the clinicians communication style affects womens responses to being told about HPV. Women preferred direct communication rather than a letter and reassurance and minimisation of the seriousness of the infection. 4 Clinical Skills Page 56 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education References 1. Mitchell H (1993) Pap Smears Collected by the Nurse Practitioners. Oncology Nurses Forum 20(5): 807-10. 2. http://medicalboardvic.org.au/content.php Accessed 30 January 2007 3. Howarth, G. Chaperone use in medical practice. Available at: www.medpharm.co.za/safp/2003/ mar/chaperone.html 4. Towler B, Irwing L and Shelley J (1993) The Adequacy of management of women with CIN2/3 Pap Smear Abnormalities. Medical Journal of Australia 159: 523-28. 5. Schiels MJ, Sanson-Fisher R, Haplin Sand Redman S (1994) Notication and follow-up of Pap Test Results: Current Practices and Womens Preferences. Preventive Medicine 23: 276-83. 6. Mc Caffrey K, Waller J, Forrest S, Cadman L, Szarewski A and Wardle J (2004) Testing Positive for Human Papillomavirus in Routine cervical Screening: Examination of Psychosocial Impact. BJOG: an International Journal of Obstetrics and Gynaecology;111: 1437-43. Additional Readings National Health and Medical Research Council (2005) Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected This document can be sited or downloaded from NHMRC website: http://www. nhmrc.gov.au/publications/synipses/wh39syn.htm Chapter 10. Kelaher M et al. (1997) The Impact of Culture and Ethnicity on cervical screening in Queensland. University of Queensland, Brisbane. Commonwealth Department of Human Services and Health (1994) Making the Pap Smear Better Report of the Steering Group of Quality Assurance in Screening for the Prevention of Cancer of the Cervix. Canberra. Department of Health, Housing. Local Government and Community Services (1991) Screening to Prevent Cancer of the Cervix. Canberra. Straton J (1994) Recruitment for Cervical Screening. A review of literature. National Cervical Screening Program. Australian Government Publishing Service, Canberra. Supporting Materials PowerPoint Presentation 4.1: Communication skills; Part 2 Section of the Handbook CD. The link between cervical cancer and HPV (human papilloma virus) brochure can be viewed on www. cancerscreening.gov.au or ordered from Queensland Cervical Screening Program website www.health.qld. gov.au/cervicalscreening Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 57 Clinical Skills 4.2 The Pap smear Key concepts the sensitivity and specicity of the Pap smear the importance of good Pap smear technique equipment used in providing a Pap smear steps in performing a Pap smear. Learning outcomes Participants of cervical screening courses will be able to: explain and understand the limitations of the Pap smear describe the basic techniques involved in providing a Pap smear identify equipment necessary to obtain a sample. Collecting an adequate sample of cells from the cervix is crucial to obtaining a satisfactory Pap smear. An optimal cytological sample of the cervix includes epithelium from the transformation zone, the squamous ectocervix distal to it and the columnar endocervix proximal to it using appropriate specimen collection devices. To ensure that an optimal specimen is obtained, adequate clinical training is required. SUMMARY INFORMATION Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 59 Clinical Skills 4.2 The Pap smear Accuracy of screening tests The Pap smear is a cytological test designed to detect abnormal cervical cells. It is also a test with inbuilt limitations. Even in the most highly trained and experienced hands false negative and a smaller number of false positive results will sometimes occur. Causes of false negative results include screening and interpretation errors. False negatives also result from sampling errors, where the actual lesion is not sampled or is not transferred from the sampling device to the slide or vial. There are two critical components that determine the tests accuracy: sensitivity and specicity. Sensitivity is the probability that the test is positive, given that the person has the disease. Specicity is the probability that the test is negative, given that the person does not have the disease. The Pap smear is generally considered to be a very specic test for high grade lesions or cancer, but only moderately sensitive. High specicity means that cytology correctly identies a high proportion of women who do not have high-grade lesions or cancer. Australian Health Technology Advisory Committee (AHTAC) reported an average specicity of 69% and an average sensitivity of 58% in 28 studies evaluating the accuracy of the Pap smear as a screening test. 1 Other studies have placed the specicity of the Pap smear as being as high as 80-95% for CIN 1 lesions or worse. This SUPPORTING INFORMATION highlights the importance of regular screening since the occurrence of a false negative is uncommon and there is every chance that the abnormality will be picked up at the next smear. It has been estimated that regular two-yearly screening prevents an adverse outcome from many false negatives and will prevent at least 90 percent of cervical cancers in the screened population. 1 The importance of good Pap smear collection technique The objective of a Pap smear is to sample cells from the transformation zone of the cervix. This is the site at which the cell abnormalities which precede the development of squamous cell carcinoma of the cervix are usually found. The quality of the Pap smear sample depends on the technique used and the adequacy of equipment. Health professionals who provide Pap smears should be trained in both the theoretical aspects of screening and clinical tuition that includes appropriate communication skills to ensure that all aspects of cervical screening are covered. What is a satisfactory Pap smear? There is consensus amongst cytologists that a satisfactory Pap smear should: contain sufcient cellular material sampled from the transformation zone be appropriately xed to ensure a good state of preservation Page 60 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education in a Pap smear include the use of bivalve rather than a Simms speculum, ensuring adequate visualisation of the cervix and the transformation zone where possible and using an appropriate device to sample the endocervix. 4
The Pap smear procedure Equipment used to collect a Pap smear There are a number of different sampling instruments that are used in performing a Pap smear. These instruments include: Ayres Spatula to collect ectocervical cells (this device should be used in conjunction with a device to collect endocervical cells, eg Cytobrush) Cytobrush to collect endocervical cells (this device should be used in conjunction with a device to collect ectocervical cells, eg Ayres spatula) Cervex sampler to collect both ectocervical and endocervical cells*. 5 *In some cases it may be appropriate to use a Cytobrush in conjunction with a Cervex sampler. Steps in collecting a Pap smear The steps for collecting a Pap smear are contained in the booklet, Screening for the Prevention of Cervical Cancer which is available from the National Cervical Screening Program, call 13 15 56. have clearly visible cellular material which is not obscured by blood or inammatory cells. 2
If unsatisfactory the laboratory report will state why and will provide recommendations on when the Pap smear should be repeated and any treatment, for example, local oestrogens, that may assist in increasing the quality of the repeat Pap smear. In relation to sufciency of cellular material sampled, an unsatisfactory Pap smear has been dened as a smear that contains fewer than 10,000 well visualised endocervical cells and/ or squamous epithelial cells (or 5,000 for liquid based preparations). 3
There has been much debate about the presence of endocervical cells in the Pap smear. Endocervical cells are a good indicator that the transformation has been sampled and it is recommended that a practitioners smears should have an endocervical component in at least 85% of the smears they collect. 4 However, it is more important that the practitioner is certain that they have visualised and sampled the transformation zone. If this is the case then the Pap smear does not need to be repeated if no endocervical cells are present as there may be physiological factors that reduce the ability to sample the endocervix such as cervical stenosis. The proportion of smears containing an endocervical component is highest in young women and it decreases with age of a woman. Practitioner-related factors that inuence the likelihood of endocervical cells being present Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 61 References 1. Australian Health Technology Advisory Committee (1998) Review of automated and semi-automated cervical screening devices, Commonwealth of Australia, Canberra. 2. Commonwealth Department of Human Services and Health (1994) Making the Pap Smear Better Report of the Steering Group of Quality Assurance in Screening for the Prevention of Cancer of the Cervix. Commonwealth Department of Human Services and Health, Canberra. 3. Australian Government, National Health and Medical Research Council (2005) Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities. Australian Government, Canberra. 4. Commonwealth Department of Health and Family Services (1998) Screening for the Prevention of Cervical Cancer, Australian Government, Canberra. 5. Royal College of Obstetricians and Gynaecologists (2002) Gynaecological Examinations: Guidelines for Specialist Practice London. Website www.rcog.org.uk Clinical Skills Additional Readings Commonwealth of Australia, Commonwealth Department of Health and Family Services(2005) titled Screening for the Prevention of Cervical Cancer at www.cancerscreening.gov.au Supporting Materials PowerPoint Presentation 4.2 Part 2 Section of the Handbook CD. Also view separate CD titled Sensitive Examination Technique in the DVD case. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 63 4.3 Interpretation of Cytology Reports Clinical Skills Understanding the Pap smear result is crucial to the provision of cervical screening. Changes to the terminology for Pap smears came into effect in July 2006 with the implementation of the NHMRC Guidelines for the Management of Asymptomatic Women with Screen-detected Abnormalities. 1
In addition, the Pap smear provider can assist the cytologist to interpret the Pap smear and the pathologist to make appropriate recommendations for individual women by including appropriate information on the Pap smear request form. SUMMARY INFORMATION Key concepts Australian Modied Bethesda System (AMBS) 2004 terminology the Pap smear report common Pap smear results common information to include on the Pap smear request form. Learning outcomes Participants of cervical screening courses will be able to: understand and explain Pap smear reports in the context of new terminology interpret a Pap smear report complete a Pap smear request form with the appropriate relevant information required by the laboratory. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 65 Australian Modied Bethesda System (AMBS) 2004 terminology The terminology for the reporting of cervical cytology was changed in July 2006 to be closer to the internationally accepted Bethesda system allowing meaningful interpretation of international research data. It was also recognised that there was poor reproducibility for distinguishing between the subtypes (Nonspecic minor change (NSMC), HPV and Cervical intraepithelial neoplasia 1 (CIN 1) of low grade cytology and that this low grade report mostly represents the changes of a productive HPV infection in squamous cells. 1
The terminology for cervical histology, however, remains unchanged. Therefore intraepithelial lesions conrmed histologically will still be reported according the Systematised Nomenclature of Medicine (SNOMED) terms, i.e. CIN 1, 2 and 3 etc. 1 The Australian Modied Bethesda System 2004 is outlined in the table below which highlights the comparison with previous terminology. SUPPORTING INFORMATION New Australian NHMRC terminology AMBS 2004 1994 Australian NHMRC terminology Squamous abnormalities Possible low-grade squamous intraepithelial lesion (possible LSIL) Low-grade epithelial abnormality Low-grade squamous intraepithelial lesion (LSIL) Low-grade epithelial abnormality Possible high-grade squamous lesion (possible HSIL) Inconclusive, possible high- grade squamous abnormality High-grade squamous intraepithelial lesion (HSIL) High-grade epithelial abnormality Squamous cell carcinoma High-grade epithelial abnormality Glandular abnormalities Atypical endocervical cells of undetermined signicance Low-grade epithelial abnormality Atypical glandular cells of undetermined signicance Low-grade epithelial abnormality Possible high-grade glandular lesion Inconclusive, possible high- grade glandular abnormality Endocervical adenocarcinoma in situ High-grade epithelial abnormality Adenocarcinoma High-grade epithelial abnormality Clinical Skills 4.3 Interpretation of Cytology Reports Table 2: Terminology of Cervical Abnormalities Page 66 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education The Pap smear report The Pap smear provider will usually receive the Pap smear result within two to 14 days depending upon where the specimen was collected and where it was examined. Pap Smear Report Forms Pap smear report forms differ in their format however, they contain similar information. The information on a Pap smear report includes: Specimen: Identies the site of the cytology samples. Possible explanations are: Slide Pap Smear - Cervical Slide Pap Smear - Vault This section will also note whether it is a conventional Pap smear sample or a Thin Prep sample. Result: Identies if the result is negative or abnormal. Possible results include: Negative for Intraepithelial Lesion or malignancy Possible Low-Grade Squamous Intraepithelial Lesion Low-Grade Squamous Intraepithelial Lesion Possible High-Grade Squamous Lesion High-Grade Squamous Intraepithelial Lesion Unsatisfactory Specic diagnosis: A more detailed description of the result is given in this section of the report. Along with the report on the presence or absence of any cellular abnormality, the coexisting presence of specic microorganisms may be given. This part of the report also includes a comment on the presence or absence of an endocervical component. Recommendations: These are according to the current NHMRC guidelines. For example, a negative smear result from women who has no symptoms or history of cervical pathology would have a recommendation of: Repeat in 2 years. Common Pap smear results About one in every ten Pap smear results will have a comment or indicate some kind of problem. Many of these are not serious, and most cell changes in the cervix are not due to cancer. Unsatisfactory Pap Smears Sometimes the Pap smear report will indicate that the sample was unsatisfactory. This may happen for a variety of reasons: the cells may be obscured by blood or inammation / mucous Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 67 there may not be enough cells on the sample to give an accurate assessment the cells may be atrophic and difcult to interpret the smear may not have been properly prepared, or the slide may have been broken during transit to the laboratory. If any of these problems occur, a woman will be asked to have another Pap smear in approximately six to 12 weeks. This allows time for the cells of the cervix to be renewed so that there will be sufcient cells available to obtain a satisfactory sample. An atrophic smear can be difcult for the cytologist to interpret. Atrophic Pap smears are often seen in post-menopausal and post natal- women, particularly if they are breastfeeding. These Pap smears result from decreased oestrogen levels. It is recommended that if the Pap smear is unsatisfactory due to atrophic changes, the woman has a repeat Pap smear in 3 months after being treated with local oestrogen. Clinical Skills Inammatory Pap Smears Sometimes a Pap smear will show signs of inammation. This may be caused by an infection caused by a micro-organism such as Candida Albicans or Trichomonas. Sometimes the cause of the inammation may be detected by the Pap smear; however additional investigations should be undertaken to identify and treat the cause. Squamous and Glandular Abnormalities There are two types of cervical abnormalities: squamous and glandular which are described in Table 3. Important information to include on the Pap smear Request Form The following information will assist the laboratory to interpret the Pap smear and make recommendations that are appropriate for each womans specic history. These include: medical record number name (previous surname if applicable) date of birth address date of Pap smear collector date of the last Normal Menstrual Period (LNMP) site: cervical or vaginal vault Page 68 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education hormonal therapy: Hormone Replacement Therapy, Oral Contraceptive Pill, Implanon, Depo Provera etc hysterectomy abnormal history of symptoms* such as post coital bleeding (PCB) and intermenstrual bleeding (IMB) abnormal or suspicious appearance of the cervix* pregnancy (gestation) Aboriginal and Torres Strait Islander status. *NOTE: the Pap smear may be part of the investigations for abnormal symptoms or appearances and in itself does not provide a diagnosis for signs or symptoms that should be explored further. A normal Pap test can be obtained in the presence of an invasive cancer. Histology results Prior to the introduction of the NHMRC guidelines in 2006, abnormal Pap smear results were described as cervical intraepithelial neoplasia (CIN) under the 1994 Australian NHMRC endorsed terminology. From 3 July 2006 cytology results are reported using the Australian Modied Bethesda System 2004 and will incorporate terminology such as LSIL and HSIL. CIN may be reported on cytology results under Specic Diagnosis and CIN will continue to be used to report histological cervical cell changes. CIN is graded into CIN 1 (mild), CIN 2 (moderate) and CIN 3 (severe) cervical cell changes. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 69 Terms used in describing results What it means Squamous abnormalities Possible low-grade squamous intraepithelial lesion (Possible LSIL) Non-specic minor squamous cell changes Low-grade squamous intraepithelial lesion (LSIL) A low grade squamous abnormality of the cervix consistent with HPV infection Possible high-grade squamous lesion (Possible HSIL) Changes that suggest, but fall short of a high-grade squamous intraepithelial lesion or SCC High-grade squamous intraepithelial lesion (HSIL) High grade pre-cancerous change consistent with CIN2, CIN3 Squamous cell carcinoma The presence of cancer in the squamous cells Glandular abnormalities Atypical endocervical cells of undetermined signicance Non-specic minor cell changes in endocervical cells Atypical glandular cells of undetermined signicance Non-specic minor cell changes in glandular cells Possible high grade glandular lesion Changes that suggest, but fall short of, adenocarcinoma in situ or adenocarcinoma Endocervical adenocarcinoma in situ Adenocarcinoma in situ (abnormal cells are restricted to the surface epithelium) Adenocarcinoma High grade abnormality affecting the glandular or columnar cells of the cervix (adenocarcinoma) (Source. Queensland Health Fact Sheet, Cervical Screening Program 2000) Table 3: Types of Cervical Abnormalities Page 70 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education References 1. Australian Government, National Health and Medical Research Council (2005) Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities. Australian Government, Canberra. Supporting Materials PowerPoint Presentation 4.3 Interpretation of Cytology Reports. Part 2 Section of the Handbook CD. The National Screening Program produces two booklets for women: Larly uclccllon ls lhc 8csl Prolccllon An Abnormal Pa Smcar Pcsull These can be viewed or downloaded from the website www.cancerscreening.gov.au If quantities are required they can be ordered from the Queensland Cervical Screening program website: www.health.qld.gov.au/cancerscreening Brochure Brochure Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 71 Clinical Skills 4.4 The Management of Screen Detected Abnormalities Key concepts the difference between recommendations for asymptomatic women and symptomatic women overview of the NHMRC Guidelines Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities. Learning outcomes Participants of cervical screening courses will be able to: differentiate between and explain the signicance of asymptomatic and symptomatic women know where to source guidelines relating to the management of asymptomatic women with screen detected abnormalities. The management and treatment of screen-detected abnormalities involves low grade squamous abnormalities, high-grade squamous abnormalities and cervical glandular abnormalities. SUMMARY INFORMATION Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 73 Clinical Skills 4.4 The Management of Screen Detected Abnormalities SUPPORTING INFORMATION The National Health and Medical Research Council (NHMRC) Guidelines Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities, are for the management of asymptomatic women with screen detected abnormalities. Therefore women who are symptomatic need to be managed in accordance with their presenting history and symptoms. Symptoms that may require specic management outside the NHMRC guidelines include women who present with symptoms such as: intermenstrual bleeding post-coital bleeding post-menopausal bleeding. Women with any of the above signs or symptoms or any other signs or symptoms of concern should be referred for further tests to a specialist gynaecologist so that their condition can be assessed and appropriate management plan formulated. Women with intermenstrual bleeding or post-coital bleeding should be managed in accordance with the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) Guidelines for the management of intermenstrual and postmenopausal bleeding. These guidelines recommend appropriate management of women presenting with intermenstrual bleeding or post-coital bleeding and referral indications. 2 Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities About two million Australian women have a Pap smear each year. 1 The clinical management of women that present with an abnormal Pap smear involves health professionals that work across many sectors and disciplines. In July 2006, the NHMRC released guidelines Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities. These guidelines are a population health package encompassing: new terminology for the reporting of Pap smears (The Modied Bethesda System 2004) information about the natural history of cervical cancer and HPV infection the management of squamous and glandular abnormalities management for special clinical circumstances which include: - pregnancy - immunosuppressed women - women following hysterectomy - postmenopausal women with normal endometrial cells - women exposed to diethylstilboestrol (DES) in utero Page 74 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education monitoring and implementation. The NHMRC guidelines are integral to the Australian National Cervical Screening Program with a short two-year screening interval. It is important to remember that these guidelines are not prescriptive, except to laboratories, and clinicians and women can still customise management to suite individual circumstances. References and Additional Reading 1. Australian Government, National Health and Medical Research Council (2005) Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities. This document can be sited or downloaded from NHMRC website: http://www.nhmrc.gov.au/publications/ synopses/wh39syn.htm 2. The Royal Australian College and New Zealand College of Obstetricians and Gynaecologists, College Statement July 2004. Supporting Materials PowerPoint Presentation 4.4: Management of Screen Detected Abnormalities. Part 2 Section of the Handbook CD. Extensive information relating to the new NHMRC guidelines has been prepared to assist general practitioners and women by the National Cervical Screening Program. www.cervicalscreening.gov.au Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 75 Key concepts follow-up and duty of care follow-up protocols and processes. Learning outcomes Participants of cervical screening courses will be able to: explain the importance of follow up procedures for abnormal Pap smear results discuss the importance of follow-up protocols and processes. It is essential that Pap smear providers understand Pap smear results and have an effective system for communicating results to women. This is particularly crucial where the result is abnormal. Medico- legal cases have resulted from women not being informed of an abnormal Pap smear result and consequently not receiving appropriate management. To ensure appropriate follow-up occurs, medical practitioners should establish systems and standards for the review and processing of all Pap smear reports. An appropriate explanation of the Pap smear result and any subsequent follow-up should be given to women in lay terms. It is recommended that abnormal Pap smear results, options for further investigations / treatment, referral and other relevant issues be discussed directly with the woman. SUMMARY INFORMATION Clinical Skills 4.5 Follow Up and Referral Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 77 Clinical Skills 4.5 Follow Up and Referral Laboratories are responsible for communicating Pap smear results, in writing, directly to the Pap smear provider. Laboratories can also supply copies of reports to other medical practitioners when requested by the Pap smear provider or by the woman who has had a Pap smear. It is not the responsibility of the laboratory to notify women directly, or to provide them with a copy of their report. It is a requirement of National Pathology Accreditation Advisory Council (NPAAC) that laboratories process 90% of smears within ve working days. The turnaround time for Pap smear results may vary from ve days to 14 days depending on the location of the Pap smear provider and laboratory workload. This allows for the prompt follow-up of abnormalities. Where a Pap smear provider is not the womans usual GP, he /she should ask the laboratory to forward a copy to the womans nominated GP (if the woman consents to this) to ensure continuity of care. It is the responsibility of the Pap smear provider to establish with a woman a mutually acceptable method of obtaining the results of her Pap smear. It is a womans responsibility to follow this advice and ensure the Pap smear provider has her current details such as her current address, telephone number etc. It is appropriate for a woman, if she requests, to be given a copy of her Pap smear result. SUPPORTING INFORMATION All Pap smear reports should be reviewed by the Pap smear provider. Whilst reports include a recommendation based on the NHMRC Guidelines, it is important that this recommendation is considered in view of the womans history and presentation, as the laboratory does not necessarily have access to this information. The Pap smear provider on review of the results and recommendations needs to establish a process for the communication of results to women and decide which results need further discussion/action. An explanation of the results should be given to a woman in the language that she can understand. The date for the next Pap smear should also be advised at that time. Fail safe procedures must exist to ensure that every woman with an abnormal result is informed of this result with sensitivity and once a choice of referral is made, that her prompt attendance for assessment is monitored. If the woman with an abnormal Pap smear has not made contact as arranged, the Pap smear provider, should make every attempt to notify her by telephone or mail and should keep a record of such attempts. The most frequent legal claims initiated against doctors concerning Pap smears arise from the failure to communicate test ndings to the client. 1 In one study it was found that 93% of women with an abnormal Pap smear result reported having been notied of their result while 11% of women whose result was abnormal were unaware that an abnormality had been detected. 2 Page 78 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education References 1. Towler B, Irwing L and Shelley J (1993) The Adequacy of management of women with CIN2/3 Pap Smear Abnormalities. Medical Journal of Australia 159: 523-28 2. Schiels MJ, Sanson-Fisher R, Haplin Sand Redman S (1994) Notication and Follow-up of Pap Test Results: Current Practices and Womens Preferences. Preventive Medicine 23: 276-83 3. Commonwealth Department of Human Services and Health (1994) Making the Pap Smear Better Report of the Steering Group of Quality Assurance in Screening for the Prevention of Cancer of the Cervix. Commonwealth Department of Human Services and Health, Canberra. Considerations should always be given to maintaining womans condentiality when providing results. For example a woman may wish to have her results sent to an address other than her residential address. Those details should be established at the time of providing a Pap smear. Recall Systems As mentioned above, laboratories are responsible for communicating Pap smear results to a Pap smear provider who in turn is a responsible for communicating Pap smear results to women. It is the responsibility of the Pap smear provider to establish with a woman a mutually acceptable method for obtaining the results of her Pap smear. This highlights the importance of ensuring the Pap smear provider has the womans current contact details such as address, telephone number etc. 3 If a woman with an abnormal Pap smear has not made contact as arranged, the medical practitioner has a duty of care to ensure she is notied of this and should attempt to notify her by telephone or mail and keep a record of such attempts. A protocol for notifying women of abnormal results and a documented recall system is an important risk management strategy that can assist in ensuring women with abnormalities are appropriately followed up. In many practices, the Practice Nurse coordinates this recall system. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 79 Clinical Skills Supporting Materials PowerPoint Presentation 4.6 Follow up and Referral Part 2 Section of the Handbook CD. A client booklet: An Abnormal Pap Smear, what it means for you (Commonwealth of Australia 2006) has been developed for women who have an abnormal Pap smear result. This publication is available from the Queensland Cervical Screening Program website www.health.qld.gov.au/ cervicalscreening and from the National Cervical Screening Program www.cervicalscreening.gov.au Shorter version of this information is available from the Queensland Cervical Screening Program . It can be viewed or ordered from the website www.health.qld.gov.au/cervicalscreening Additional Readings Commonwealth Department of Human Services and Health (1994) Making the Pap Smear Better Report of the Steering Group of Quality Assurance in Screening for the Prevention of Cancer of the Cervix. Commonwealth Department of Human Services and Health, Canberra. Britten N (1988) Personal View. British Medical Journal 296: 1191. Grimes D (1988) Value of negative Smear. British Medical Journal 296: 1363. National Cervical Screening Program (2006) Pap smear results: A Guide For Women With An Abnormal Pap Smear. Straton JAY (1994) Recruitment for Cervical Screening. A Review of Literature. National Cervical Screening Program. Australian Government Publishing Service. Canberra. (Pages 17-29). Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 81 4.6 New Technologies Clinical Skills Since 1991 the National Screening Program has promoted two-yearly screening of eligible women using the Papanicolaou (Pap) smear. This strategy has been very successful in decreasing the incidence and mortality from cervical cancer. The limitations of the Pap smear have generated the development of devices to improve the sensitivity and specicity of the Pap smear and also address workforce shortages of cytologists. These include the automated thin layer slide preparation system (ThinPrep) and image analysis devices to screen slides. A number of these technologies are actively promoted to health professionals and consumers. Many laboratories in Australia offer one or more of these tests on request, for an additional fee which is not refunded through Medicare Australia or private health funds. SUMMARY INFORMATION Key concepts liquid based cytology automated and semi automated cervical screening devices. Learning outcomes Participants of cervical screening courses will be able to: identify and critically evaluate new technologies that are available for cervical screening discuss the advantages and disadvantages of different technologies and their use. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 83 The National Cervical Screening Program recommends Pap smears be used as the primary method for screening until there is sufcient evidence indicating the cost- effectiveness of new cervical screening technologies. 1 New technologies have been explored to automate cervical screening which has until recently remained largely a manual procedure in the Australian setting. Attempts to increase the sensitivity and automate cervical screening have led to the development of a number of new technologies. These include liquid-based cytology, such as ThinPrep and SurePath and automated screening devices, for example the Thin-Prep Imager and FocalPoint. Liquid- based cytology is not publicly funded in Australia at present as a review conducted by the Medical Screening Advisory Committee (MSAC) in 1998 determined there would be limited benet and substantial cost involved in publicly funding these technologies given the effectiveness of the NCSP using the conventional Pap smear (Australian Health Technology Advisory Committee, 1998). 2 MSAC is presently reviewing Automated Liquid Based Cytology in Australia. Liquid based cytology Liquid-based cytology (LBC) whether ThinPrep or SurePath thinlayer technology is the production of a thin layer of cervical cells on a microscope slide, suitable for diagnosis of cytological abnormalities. These preparations can be screened manually or by automated screening which is supplemented by manual screening. In the Private Sector, Liquid Based Cytology (usually ThinPrep in Qld) has an additional charge to the woman of approximately $30. There is no Medicare rebate. In the public sector, liquid based cytology is offered free of charge to the woman if the criteria for an adjunctive test is met as stated in the Queensland Health Policy and Protocol for the use of ThinPrep www.health.qld.gov.au/cervicalscreening Automated Screening Technology The Thin Prep Imaging System The ThinPrep Imaging System is an automated imaging and review system for use with ThinPrep thin-layer slides. It combines imaging technology to identify microscopic elds of diagnostic interest with automated stage movement of a microscope in order to locate these elds. In routine use, the ThinPrep Imaging system selects 22 elds of view for a Cytotechnologist to review. Following review of these elds, the Cytotechnologist will either complete the diagnosis if no abnormalities are identied or review the entire slide if any abnormalities are identied (Cytec, 2002). SUPPORTING INFORMATION Clinical Skills 4.6 New Technologies Page 84 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Diagram of ThinPrep vial and automated machine FocalPoint Slide Proler The FocalPoint Slide Proler prioritises the slides based on the likelihood of abnormality to help cytotechnologists reduce the incidence of false negatives, by directing attention to slides most likely to contain abnormality. In the private sector, these methods of computer-assisted screening have an additional charge to the woman of approximately $30. This technology is not available in private or public labs in Queensland. Optoelectronic Screening (TruScreen) TruScreen is a relatively new Australian- developed device that is used in conjunction with the conventional Pap smear. The TruScreen system consists of a portable console, a handpiece and a single use sensor. TruScreen uses a probe to emit electrical and light signals onto the cervix. The sensor then measures the reection and the computer analyses whether the cells are normal or abnormal. The TruScreen procedure takes an additional 1 2 minutes after the conventional Pap smear collection (Polartechnics). TruScreen is slowly being released onto the Australian market at an additional cost of approximately $35 to the woman. There is no Medicare rebate. The evidence in support of Truscreen is somewhat variable. In the context of the National Cervical Screening Program there is no evidence to support TruScreen use nor is there any obvious benet to women who are having regular Pap smears. 8 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 85 The new technologies aim to improve the quality of the cervical cell preparation, increase human screener productivity, decrease the unsatisfactory rate and increase the sensitivity of the test. NEW TESTS FOR CERVICAL CANCER SCREENING Test Goals Advantages Disadvantages Liquid-based/thin- layer preparations (e.g., ThinPrep, AutoCyte Prep) Improve the quality of the Pap smear Decrease unsatisfactory Pap smears Increase detection of cancer precursors High-quality smear for review Improved transfer of cells from collection device Residual material may be used for HPV testing Cost Increased detection of low-grade lesions in initial studies* Retraining of cytotechnologists Computer-assisted screening (AutoCyte Screen) Improve Pap smear interpretation Increase laboratory productivity Increase detection of cancer precursors Increase cytotechnologist productivity May decrease false-negative reports Cost From studies on PAPNET, increased detection of low- grade lesion* *--There is controversy about whether this signicantly benets patients. Advantages and Disadvantages of New Technologies 7 Clinical Skills Page 86 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education References 1. National Cervical Screening Program (2009) New Technologies for Cervical Screening. Australian Government Department of Health and Ageing. 1. Australian Health Technology Advisory Committee (1998) Automated and semi- automated cervical screening devices a summary Australian Health Technology Advisory Committee, Canberra. 2. The Medical Services Advisory Committee Reference 12a Assessment Report (2002) Liquid Based Cytology for Cervical Screening, Canberra. 3. Davey E, Barratt A, Inwig L, Chan SF, Macaskill P, Mannes P and Vaville M (2006) Effect of Study Design and Quality on Unsatisfactory Rates, Cytology Classications, and Accuracy in Liquid-Based Versus Conventional Cytology : A Systematic Review Lancet 367:122-132. 5. Arbyn M,Bergeron CH, Klinkhamer P, Martin- Hirsch P,Siebers G and Bulten J (2008) Liquid Compared with Conventional Cervical Cytology. A Systematic Review and Meta-analysis. Obstetrics and Gynaecology 111: 1; 167-177. 4. Cytec Corporation (2002) Thin Prep Imaging System. Cytec United Kingdom. 5. Queensland Cervical Screening Program (2002) Queensland Health Policy and Protocol for the use of Thin Prep. Queensland Health, Brisbane. 8. Singer A, Coppleson M Canfell K, Skladnev V, Mackellar G and Pisal N (2003) A real time optoelectronic device as an adjunct to the Pap smear for cervical screening: A multicentre evaluation. International Journal of Gynaecological Cancer, 13: 804-811. Supporting Materials PowerPoint Presentation 4.6 New Technologies Part 2 Section of the Handbook CD. Queensland Health Policy and Protocol for the Use of Liquid Based Cytology (LBC), Information Sheet see website www.health.qld.gov.au/cervicalscreening Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 87 4.7 HPV Vaccination and HPV DNA Testing Clinical Skills Infection with Human papillomavirus (HPV) is a major risk factor for cervical cancer. There are over a 200 strains of genotypes of HPV however infection with HPV 16 is responsible for 50% of cervical cancers and HPV 18 is responsible for an additional 20% of cancers. 1 Vaccines have been developed for preventing infection with high risk HPV 16 and 18. HPV DNA testing is available to identify if a woman has HPV and whether it is a high risk type HPV or a low risk HPV. This test is has been approved for use as a test of cure for women following treatment of a high-grade cervical abnormality. Key concepts HPV vaccination HPV DNA testing. Learning outcomes Participants of cervical screening courses will be able to: explain the concept and purpose of HPV vaccine describe the National HPV Vaccination Program explain the HPV test of cure for women treated for high-grade cervical abnormalities. SUMMARY INFORMATION Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 89 Persistent infection with high risk HPV types can cause cell changes that may lead to cervical cancer over a period of about 10 years. High risk HPV types 16 and 18 are linked to 70-80% of cervical cancers and about 50% of high grade cervical pre-cancerous lesions in Australia. HPV types 16 and 18 also account for about 25% of low grade cervical abnormalities.. Low risk HPV types include type 6 and 11 which are linked to approximately 90% of genital warts cases and around 10% of low grade cervical abnormalities. 1 Two vaccines for prevention of infection with high risk HPV have been developed and are currently available in Australia; a quadrivalent vaccine against types 6/11/16 and 18 called Gardasil and a bivalent vaccine against 16 and 18 called Cervarix. Gardasil is licensed for use in Australia for females aged 9 to 26 years and males aged 9 to 15 years. Cervarix is licensed for use in Australia for women aged 10 to 45 years. Both vaccines are comprised of three doses to ensure optimal protection. 2 These vaccines are most effective when given before exposure to HPV (that is, before any sexual activity takes place) to produce immunity to HPV. The vaccines assist the womans immune system to destroy the virus before an infection becomes fully established. The HPV vaccine should not be seen as a replacement for Pap smears. Being vaccinated lowers the chances of becoming infected with the high risk HPV types contained in the vaccine. Women who have ever had sex need to continue with two-yearly Pap smears so that any changes to the cells of the cervix can be detected and if necessary, treated in accordance with the NHMRC Guidelines for Asymptomatic Women with Screen Detected Abnormalities. www.nhmrc.gov.au/publications The duration of immunity from vaccination with Gardasil is not yet known, but research has shown that Gardasil confers protective immunity and efcacy for at least ve years and there is no indication currently that boosters will be needed. In addition, there is evidence of immune memory response, so long term protection is likely. Clinical trials are continuing and the results will be monitored to determine whether booster doses will be needed in the future. 3
To date Gardasil is the only vaccine to be included on the Australian National HPV Vaccination program. It is estimated that the vaccination program will reduce the lifetime risk of cervical cancer by 48%, compared to the current screening system. This estimate is based on data from the National Cervical Screening Program in Australia, 100% vaccine effectiveness, lifetime duration of efcacy and 80% coverage. The vaccine should also substantially reduce the incidence of cervical precursor lesions and related interventions. 4 SUPPORTING INFORMATION Clinical Skills 4.7 HPV Vaccination and HPV DNA Testing As HPV vaccines do not protect against all cancer-causing HPV types, vaccinated women still need to have regular Pap smears through the National Cervical Screening Program to ensure early detection and treatment of cervical lesions. Page 90 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education As Australia is the rst country in the world to commence a national vaccination program against HPV, Australian women will be the rst cohort of young women in the world where further reductions in cervical cancer mortality and morbidity are likely to be observed. 4 The National HPV Vaccination Program Implementation of a vaccination program for 12 to 26 year old women has been shown to be cost effective in Australia. 4 The National HPV Program is funded by the Australian Government. The school based program commenced in April 2007 and the community based program in July that year. Under the program, the HPV quadrivalent vaccine Gardasil is provided free to girls and women aged 12 to 26 years. There are three aspects to the program: an ongoing vaccination program for all 12 year olds girls a two year catch-up program for school girls aged 13-18 and a general practitioner based program for women aged 19 to 26 years. The catch-up and general practitioner based programs ended in June 2009. The National HPV Vaccination program represents an additional prevention strategy against cervical cancer and other HPV related diseases and will complement the National Cervical Screening Program. A National HPV Vaccination Program Register Legislation was passed by the Australian Government in 2007 to establish a HPV Program Register which would receive data from all states and territories. Personal details are kept condential and only used to evaluate the impact of the HPV Vaccination program on cervical cancer rates, to issue reminders if the course is incomplete, to issue conrmation the course is complete and to contact vaccine recipients should booster doses be required. 3
For more information see website: www.hpvregister.org.au HPV DNA Testing As mentioned earlier there is a well established link between cervical cancer and infection with HPV. A number of types of HPV (commonly referred to a high risk or oncogenic HPV) are associated with cervical cancer (primarily, HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68). A test is available to detect HPV, called an HPV DNA test. This test identies if a woman has HPV and whether it is a high risk type of HPV or a low risk HPV. The test is usually collected at the same time as a Pap smear using the same or similar collection devices. This test is available in Australia but is quite expensive (approximately $80.00) and is only subsidised by the government as a test of cure. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 91 References 1. Clifford GM, Franceschi S, Diaz M et al. (2006) HPV type-distribution in women with and without neoplastic diseases. Vaccine 24 Supplement 3: s26-34 2. Australian Government, Department of Health and Ageing (2009) National Cervical Screening Program. www.cancerscreening.gov.au 3. Wain G 2008 HPV Vaccines and the Australian Human Papillomavirus (HPV) Vaccination program. Cancer Forum, 32;2: 96-98 4. Kulasingam S, Connelly L, Conway E et al .2007 A cost-effectiveness analysis of adding human papilloma virus vaccine to the Australian National Cervical Screening Program. Sexual Health, 4 165-17. 5. MSAC Reference 12a Assessment report (2002) Liquid based cytology for cervical screening. Commonwealth of Australia, Canberra. 6. Davy M (2006) The Queensland Cervical Screening Program Update. Queensland Health, Brisbane. 7. Mc Crory DC, Matchar DB et al (1999) Evaluation of cervical cytology. Agency for Health Care Policy and Research, Publication No. 990E010, Rockville, MD. 8. Garland S M (2006) Human Papillomavirus Vaccines: Challenges to Implementation. CSIRO Publishing and MINNIS Communications Sexual Health, 3: 63-65. HPV DNA testing in Australia is recommended under the National Health and Medical Council (NHMRC) Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities who have had treatment for HSIL in order to identify those women who are at risk of further high-grade disease. www.nhmrc.gov.au/publications HPV DNA Test of Cure is only covered by Medicare for women with a biopsy-proven HSIL following treatment. For these women it is recommended that HPV DNA testing should be performed in addition to a Pap smear 12 months after treatment and then again annually with a conventional Pap smear until both tests appear normal on two consecutive occasions. 1,6
Queensland Health has developed a Policy and Procedure for HPV DNA Test of Cure. www.health.qld.gov.au/cervicalscreening Additional applications of HPV DNA testing are to be explored further in the Australian setting in view of the implementation of the National HPV Vaccination Program. Clinical Skills Page 92 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Supporting Materials PowerPoint Presentation 4.7 HPV Vaccine and HPV Testing Presentations: Part 2 Section of Handbook CD. Information Sheet: Queensland Health Policy and Procedure for HPV DNA Test of Cure www.health.qld.gov.au/cervicalscreening Quality Assurance Activities SECTION 5 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 93 Key concepts medico-legal aspects of cervical screening risk management strategies indemnity procedure guidelines quality assurance check list. Learning outcomes Participants of cervical screening courses will be able to: describe the key components of a high quality system for cervical screening within medical practice discuss the medico-legal aspects and risk management strategies for cervical screening explain how they would seek advice on both individual and practice indemnity situations. The provision of high quality cervical screening is essential in achieving positive outcomes for eligible women. A number of medico-legal issues have been associated with cervical screening which Pap smear providers need to be aware of. Claims have been made against Pap smear providers and laboratories. A number of key principles need to be taken into consideration as part of risk management to ensure that service providers are meeting their legal responsibilities for cervical screening. SUMMARY INFORMATION 5.1 Risk Management Quality Assurance Activities SECTION 5 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 95 5.1 Risk Management Quality Assurance Activities Delay in diagnosis or failure to diagnose cancer are the main causes of medically related litigation. 1 Claims against Pap smear providers can allege: failure to offer cervical screening failure to investigate vaginal bleeding, particularly post coital bleeding failure to collect appropriate cells during the procedure failure to arrange specialist care when there is vaginal bleeding or any other concerning symptom/s failure to inform a woman of an abnormal Pap smear result and to arrange for appropriate care. 2
Claims against laboratories can allege: failure to detect and report abnormal cells on a Pap smear failure to report a specimen as unsatisfactory For the claim of negligence to succeed, the plaintiff must prove that: a duty of care was owed and what the standard of that duty was the care offered was less than a reasonable standard for the duty of care the illness experienced was a direct consequence of that failure of the duty of care. 2
Within the cervical screening program, the area of contention relates to the reasonable standard for the duty of care for both the medical practitioner and the laboratory. To date, little progress has been made in dening objective standards of care. Several reasonably high- prole cases have proceeded to trial, most have found in favour of the plaintiff. Other cases have been settled out of court. This means that each case of alleged negligence still has to be defended on an individual basis. 2 In the present highly litigious world all those involved in cervical screening have their own professional indemnity insurance to ensure that their personal nancial interests are adequately protected. It is vital that medical Pap smear providers have proper protection against the costs associated with defending a legal action. Whether the action has any basis in truth or not, it will still be an expensive exercise to prove their innocence. 3 There are various medical indemnity insurers that can be accessed. The Royal Australian College of General Practitioners provides advice on medical insurers. 3 Managing risk in General Practice appropriate training is vital ensuring women are aware the Pap smear is not perfect but regular screening offers the best protection against cervical cancer good Pap smear technique SUPPORTING INFORMATION Page 96 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education It is important to review these reports and identify any areas where the indicators differ from the average results provided. For example, a high number of Pap smears without an endocervical component could indicate that the transformation zone is not being sampled adequately and may indicate the need for further training in Pap smear technique. Participating in Quality Assurance Activities Pap smear providers should be encouraged to participate in quality assurance activities, e.g. Pap smear audits or specic training programs. Credits often apply for participation in these activities which contribute to continued vocational registration for medical practitioners or continued fellowship of the Royal Australian College of General Practitioners (RACGP) and Royal Australian and New Zealand College of Obstetricians and Gynaecologists ( RANZCOG). 4 Laboratory Quality Assurance Pathology laboratories must be registered with the National Association of Testing Authorities (NATA). A list of registered pathology laboratories is available from NATA, RACGP and RANZCOG. NATA requires all cytology laboratories to have internal quality assurance mechanisms and to be actively involved in The Royal College of Pathologists of Australia (RCPA) external quality assurance program. 5,6,7 following the recommendations for the treatment and management of asymptomatic women with screen-detected abnormalities investigation of women with symptoms or signs even if the Pap smear is reported as negative referral for a specialist assessment when indicated establishing practice standards for: - the return of results - the notication of results - follow-up processes for abnormal results - recall and reminder systems advising women of the Pap Smear Register (PSR) and promoting the benets of the PSR as a back-up reminder system and safety net. 4 Quality assurance mechanisms Obtaining a Quality Pap Smear It has been demonstrated that feedback improves the performance of Pap smear providers. 4 Laboratories provide regular feedback to Pap smear providers about the following: the proportion of unsatisfactory smears the proportion of smears that lack an endocervical component the proportion of Pap smears showing abnormalities. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 97 References 1. Curtis P, Varenholt JJ Skinner B Addison L, Resnick J and Kebede M (1993) Development of Pap Smear Quality Assurance System in Family Practice. Clinical Research and Methods. 25:135-39. 2. Kearney MA (1996) Is There a Medical Litigation Crisis. Medical Journal of Australia 164: 178-182. 3. Australian Doctor (1998) Litigation is becoming an issue. An article. March 1998. 4. www.racgp.org.au 5. www.ranzcog.edu.au 6. www.rcpaqap.com.au 4. Commonwealth Department of Human Services and Health (1994) Making the Pap Smear Better Report of the Steering Group of Quality Assurance in Screening for the Prevention of Cancer of the Cervix. Commonwealth Department of Human Services and Health, Canberra. Quality Assurance Activities Additional Readings Commonwealth Department of Human Services and Health (1994) Making the Pap Smear Better Report of the Steering Group of Quality Assurance in Screening for the Prevention of Cancer of the Cervix. Commonwealth Department of Human Services and Health, Canberra. (Chapter 2) Supporting Materials PowerPoint Presentation 5.1: Risk Management Presentations: Part 2 Section of the Handbook CD. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 99 Quality Assurance Activities General practitioners play a central role in cervical screening and are in an ideal position to encourage women to participate in cervical screening. A clinical audit gives general practitioners an opportunity to enhance their awareness of cervical screening rates, the cytological quality of Pap smears performed and management of women with screen detected abnormalities in their practice. More importantly clinical audits allow general practitioners to compare their practice with an accepted standard and develop strategies to modify practice if necessary. It has been demonstrated that such activities improve performance and maintain it at a high level. 1 In addition to this, Pap smear providers should be encouraged to participate in update training programs related to Pap smear audits. SUMMARY INFORMATION Key concepts rationale and process for clinical audits in medical practice information about Continued Professional Development (CPD) activities relating to clinical audits and how to participate. Learning outcomes Participants of the cervical screening course will be able to: explain how they will utilise reports from cytology providers to improve their own practise describe how they will undertake regular audits within their own practice describe how they will identify under- screened women in their own practice as a result of the audit participate effectively in Continued Professional Development (CPD) activities relating to clinical audits. 5.2 Clinical Audits Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 101 A clinical audit is a planned medical education activity designed to help general practitioners review aspects of their own clinical performance in practice with the aim of improving patient care. 1 A clinical audit has two main components: an evaluation of the care that the individual general practitioner provides a quality improvement process. A clinical audit compares actual clinical practice against established standards of practice. A clinical audit is not the same as research. 2 The following information provides an example of SUPPORTING INFORMATION Step 1 Needs assessment Step 2 Identify standards Step 5 Monitor progress analysis Step 3 Data collection Step 4 Identifying and implementing change Quality Assurance Activities 5.2 Clinical Audits a clinical audit and has been obtained from RACGP. RACGP has kindly given Queensland Cervical Screening Program permission to reproduce this information. Why do a clinical audit? Research into evidence-based medicine shows that a clinical audit is more likely to result in changes in general practitioners behaviour and improvement in practice than traditional didactic medical education methods. As a quality improvement tool, a clinical audit is accepted internationally and supported by research. Clinical audit activities are based on the following cycle: Page 102 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Who participates in the clinical audit? Clinical audits are designed to seek the participation of a group of general practitioners. Small group audits may be designed by the group itself or may be externally designed by an education provider. (A small group consists of 4-10 participants of which 50% of those must be general practitioners). Individual general practitioners may design their own audits which may be specic to their own practice. Who organises the clinical audit? An education provider develops the audit tools, and advertises and recruits individual GPs. Many ready made clinical audits are provided by various groups, eg. divisions of General Practice, universities, RACGP and other organisations. Practice-based groups are encouraged to develop clinical audits to investigate issues of relevance to their practice. A small group clinical audit template is available on the RACGP website to assist with this development. Mode of delivery Data may be collected and collated on-line or be paper-based. Feedback mechanisms vary and may be face-to-face, on-line or via paper based materials. Program duration Clinical audits can either be of xed time duration, or by certain number of patients, depending on the prevalence of the condition or the issues for audit, eg. if presentation is quite rare, the audit may continue for more than 1 year. Other audits are structured around patient numbers, which may include large numbers collected over a short period of time, eg a practice that performs a large number of Pap smears over 3 to 6 months. Points allocation Points are allocated according to the relevant organisations standards. Information is usually readily available on-line, for example RACGP allocates 30 points to Steps 1-5 of the audit described in the Clincal Audit activities diagram on page 101. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 103 References 1. Williams PA, Williams M (1988) Barriers and Incentives for Primary Care Physicians. In Cancer Prevention and Detection. Cancer 61: 2382-90. 2. The Royal Australian College of General Practitioners 2007 QA and CPD Quality Assurance and Continuing Professional Development Program handbook 2008-2010 Triennium. The Royal Australian College of General Practitioners, Melbourne. http://www.racgp.org.au The Royal Australian College of General Practitioners has kindly given Queensland Cervical Screening Program permission to reproduce the section on Clinical Audits. Quality Assurance Activities Additional Readings Commonwealth Department of Human Services and Health (1994) Making the Pap Smear Better. Report of the Steering Group on Quality Assurance in Screening for the Prevention of Cancer of the Cervix. Commonwealth Department of Human Services and Health. Canberra. NSW Cervical Screening Program (2002) Opportunistic Cervical Screening in General Practice NSW Cervical Screening Program. Westmead Hospital, Sydney. www.csp.nsw.gov.au Supporting Material PowerPoint Presentation 5.3 Clinical Audits Presentations: Part 2 Section of the Handbook CD. Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 105 Key concepts information about the Queensland Health Pap Smear Register (PSR), its function and role Pap smear providers legal obligations with respect to the PSR. Learning outcomes Participants of cervical screening courses will be able to: explain the role and benets of the PSR encourage women to participate in the PSR explain the opt-off process to prevent the transfer of data to the PSR know how to access PSR and complete necessary documentation explain their legal obligations in relation to the PSR Cytology registers have an important role both in quality assurance and in the recruitment of women into the cervical screening program. An accurate register that identies all eligible women who are having Pap smears and how often they are having them, is essential to achieve rates of participation in a successful screening program. Registers also enable the identication of eligible women who are not having Pap smears, using population registers, such as the electoral roll, and provide a basis for targeted recruitment programs. SUMMARY INFORMATION 5.3 The Queensland Health Pap Smear Register Quality Assurance Activities Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 107 5.3 The Queensland Health Pap Smear Register Quality Assurance Activities The Queensland Health Pap Smear Register (PSR) commenced operations on 8 February 1999 under Amendments to the Health Act 1937. Provisions were then updated and transferred into the Public Health Act 2005. The current provisions commenced on 1 December 2005. The Legislation requires: 1) Pathology laboratories to provide information to the PSR 2) Protect the privacy and condentiality of womens data and support the opt-off principle 3) Pap smear providers to inform women about the PSR. Under this legislation, Pap smear providers, pathology laboratories and the PSR have legislative obligations to ensure women are correctly placed on the register. The legislation also ensures that womans information is strictly condential and access to womens information is restricted to her health care provider, and pathology laboratories. The information included on the PSR is obtained by electronic transfer from pathology laboratories which interpret Pap smears and related cervical tests. For this reason it is essential that the personal information provided about the woman is accurate to ensure her results can be matched to any previous results on the PSR. SUPPORTING INFORMATION The Functions of the PSR The PSR provides: reminders to women who are overdue for their next Pap smear as a back-up to existing reminder systems mechanisms to help ensure that women with abnormal Pap smear results or technically unsatisfactory Pap smears are advised to receive appropriate follow-up (acts as a safety net) data to help monitor and evaluate the effectiveness of the cervical screening program screening histories to assist pathology laboratories to interpret a womans current Pap smear and make clinical management recommendations screening histories for Pap smear providers to assist in clinical management. information to assist in the development of recruitment strategies for unscreened and under-screened women. Pathology Laboratory Responsibilities Pathology laboratories are required to provide Pap smear and related histology results to the PSR, no later than 4 weeks after the results of the tests are given to the person who asked for the test, unless there is a notation on the pathology request form to indicate that the womans information must not be given to the PSR. Page 108 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Pap smear provider responsibilities It is the Pap smear providers responsibility under the Public Health Act to inform each woman having a Pap smear, HPV DNA test, cervical/ vaginal biopsy and other related procedures about the PSR. This includes: the existence and purposes of the PSR, and the identifying and clinical information about the woman that may be recorded in the PSR, and that the woman may elect for her identifying and clinical information not to be automatically included in the PSR. GP information kits are available for Pap smear providers to assist them in fullling their responsibility in informing women about the PSR. (Freecall 1800 777 790 or visit www.health.qld.gov.au/cervicalscreening) Unless the woman opts-off, her identifying information and Pap smear, HPV DNA test or histology results will automatically be provided to the PSR by the pathology laboratory reading the sample. Pap smear providers who fail to inform women about the PSR will incur no penalties. The results extracted must be the nal results that have been quality assured for women who usually reside in Queensland. Pathology laboratories have a responsibility to ensure that if a woman has opted-off the PSR, her identifying information and results will be excluded from the pathology laboratory data extraction for the register. Pap Smear Register responsibilities The PSR will ensure that information is provided to Pap smear providers to assist them in fullling their responsibility in informing women about the register. The PSR will ensure that information is provided to the Laboratories to assist them in fullling their responsibility in forwarding Pap smear results to the register, for women who have not chosen to opt-off. After a womans identication is included on the PSR, the Register will send the appropriate Welcome letter to the woman stating her information has been included in the Register. Enrolment of Women on the Pap Smear Register Women are registered on the PSR when they have a Pap smear, HPV DNA Test or cervical/ vaginal histology performed. Inclusion is by an opt-off system where women are automatically included on the Register unless they specically elect for their information not be provided to the PSR. 1 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education Page 109 Quality Assurance Activities Refusal to give consent (woman wishes to opt- off) If a woman indicates she chooses not to be included on the Pap Smear Register, the Pap smear provider should write or attach a sticker -NOT FOR PAP SMEAR REGISTER on the pathology request form. The Pap smear provider will also make a notation in the womans health record or ll out an Exclusion from the Pap Smear Registry form to record the womans decision to opt-off and that the womans identifying and clinical information must not be given to the PSR. Women who have opted-off previously For women who have opted off previously, the Pap smear provider must ask the woman whether she wants to reconsider her decision each time she has a Pap smear or related test. If the woman still does not want to be included on the PSR, the Pap smear provider should write or attach a sticker NOT FOR PAP SMEAR REGISTER on the pathology request form. If the woman reconsiders her decision and tells the Pap smear provider she now wants her identifying and clinical information to be forwarded to the PSR, the provider must: make a notation in the womans health record or note on the existing (original) Exclusion form the womans decision and that the womans identifying and clinical information must now be forwarded to the PSR, and send the sample and the pathology request form to the pathology laboratory without a NOT FOR PAP SMEAR REGISTER sticker. Welcome letters When the womans rst results (either Pap smear, HPV DNA test, biopsy or hysterectomy) are received and they are registered on the PSR, a Welcome letter is automatically generated. The Welcome letter states: the information has been included in the PSR the woman may have her screening history removed from the PSR the woman may have her identifying information changed if she considers the information is incorrect, and the way the woman may have her registered screening history removed or her identifying information changed. The Welcome letter also informs the woman: what information is collected by the PSR the benets of being on the PSR Page 110 Queensland Cervical Screening Program Handbook for Providers of Medical Practitioner Education how women can access their own records from the PSR, and who can access her information and what it can be used for. Welcome letters are sent to addresses provided by the pathology laboratories. Privacy concerns For women concerned about receiving mail from the PSR, the following processes have been implemented: all PSR mail addressed to women is in a window face envelope with no items identifying the PSR. References 1. Queensland Cervical Screening Program (2005) The Queensland Health Pap Smear Register. Queensland Health, Brisbane. Additional Readings Commonwealth Department of Human Services and Health (1994) Making the Pap Smear Better. Report of the Steering Group on Quality Assurance in Screening for the Prevention of Cancer of the Cervix Commonwealth Department of Human Services and Health, Canberra. Supporting Materials PowerPoint Presentations 5.4 Queensland Health Pap Smear Register: Part 2 Section of the Handbook CD.