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- Introduction
- The Opportunistic Approach
- Impetus for Change
- Deciding on the Model
- Implementing the Change to an Organised Approach
- Future Challenges
- References
Introduction
During the 1990s, Australia made a successful transition from opportunistic cervical screening to an organised public health programme. While challenging and controversial at times, overall the transition was remarkably smooth. This paper reviews the impetus for the change, the decision-making process that was adopted, how the change was implemented and the challenges that remain in the twenty-first century. Critical factors for success at each step of the change process are highlighted.
The Opportunistic Approach
The ability to prevent cervical cancer by the detection and management of asymptomatic precursor lesions was an exciting discovery in the mid-twentieth century. 1 It gave hope that other types of cancer could be controlled and possibly eradicated in a similar fashion to the dramatic achievements made against infectious diseases via antibiotics and vaccination. A Pap smear seemed a remarkably simple test to detect women who were at risk of cervical cancer. Even the treatment of detected lesions seemed straightforward, with local surgery to the cervix having little, if any, impact on a woman’s childbearing capacity.
Pap smear testing became available for Australian women in the 1960s. No formal programme was put in place, reflecting the prevailing mode of health care delivery at the time for both clinical medicine and public health. Ownership of and responsibility for screening were not given to any person or organisation, either in the government or non-government sector. Despite this, there was considerable local enthusiasm for the possibilities of controlling this cancer.
The Cancer Councils in the eight States and Territories of Australia began raising awareness of the test with medical practitioners and, to a lesser extent, with women. This work was predominantly financed from funds raised by public donation. While a gradual introduction of screening was envisaged, so as not to overload the infant screening services, the expectation appeared to be that, increasingly, women would appreciate the benefits to be gained and therefore present for regular screening.
A small number of pathologists and gynaecologists received training overseas in the interpretation of Pap smears and the treatment methods for women with abnormalities. Upon their return to Australia, they disseminated these skills more widely. Any pathology laboratory and any gynaecologist could be involved in the care of women.
No national policy was formulated on key issues such as the age range for screening, the interval between tests, the minimum degree of abnormality on a Pap smear that justified additional testing or the type of treatment to be offered to women with abnormalities.
Eventually this type of programme became known as opportunistic screening, the name reflecting the encouragement given to women and doctors for a Pap smear to be taken whenever the opportunity arose. Australia was by no means alone in having this type of screening programme in the 1960s to 1980s; a similar situation prevailed in most developed countries.
Impetus for Change
By the 1980s, it was impossible to ignore the limited success that opportunistic screening was having. Cervical cancer was still a distressingly frequent disease. Developments in both the local and international scenes demanded a rethink as to how cervical screening should be implemented.
At a local level, three factors were influential:
- Gynaecologists began to question whether optimal gains were being made. In particular, gynaecological oncologists seemed motivated to push for change by the apparently large numbers of women still presenting with what they considered to be a preventable disease. There were concerns that an epidemic of cervical cancer, particularly among younger women, was about to be experienced. 2
- Public health was emerging as an increasingly respectable and influential discipline. The breadth of expertise within public health practitioners widened and each sub-discipline was able to contribute a critical perspective. Epidemiologists, behavioural scientists, anthropologists and health economists became vocal.
Cancer Registries were established throughout Australia. For the first time, statistics about the incidence of cervical cancer were being published. Unfavourable comparisons were made with incidence rates overseas (especially in the Scandinavian countries and British Columbia) where more organised programmes had been implemented. - The women’s health movement was gaining momentum. Most Australian States and Territories established women’s health units within their Health Departments. The failure to deliver optimal gains from cervical screening was a respectable health issue to which the women’s health lobby could add its criticisms.
Internationally, cervical screening was under critical review in the US following a leading article in the Wall Street Journal. 3 The Cartwright Inquiry in New Zealand produced a number of recommendations relevant to Australia. 4 An editorial in the Lancet entitled “Death by Incompetence†seemed in many ways to be equally applicable to Australia as to the UK. 5
In 1986 a seminal publication by the International Agency for Research on Cancer, a World Health Organisation affiliate, identified eight essential elements for a successful screening programme. 6 Publication of this monograph by an internationally respected group provided a framework for change in the Australian setting.
In 1988 these pressures were responded to. A review of cervical screening in Australia was commissioned as a joint initiative of the Commonwealth, State and Territory health authorities.
Deciding on the Model
The review engaged a much wider audience in the debate about cervical screening. For the first time, monies were provided to the States and Territories for work in areas other than direct service delivery. The resulting diverse activities included the implementation and evaluation of a variety of recruitment programmes, an information infrastructure pilot in one State, economic modelling of a range of possible programmes was undertaken and a review of quality assurance within the pathology laboratories (now more than 150 in number) was performed. This formal involvement of a wider range of activities meant that cervical screening was no longer seen as encompassing just the taking and reporting of a Pap smear and the management of women with abnormalities.
A Screening Evaluation Coordination Unit (SECU) was established within the Australian Institute of Health for the duration of the pilot projects and the review of policy. SECU had a small staff including an epidemiologist, a behavioural scientist, a statistician, a general practitioner (GP) and a health economist.
A Steering Committee was established to oversee the review and to make recommendations back to government on the policy aspects of a national screening programme. The Steering Committee was diverse in its membership and only a minority of its members were medical practitioners. Lively, and at times heated, debate occurred, most particularly over the screening interval.
Against a prevailing background in Australia of screening every one or two years, the economic modelling by SECU suggested a three-year screening interval should be adopted. The public health members of the Steering Committee supported this view but the clinical members tended to favour a one-year screening policy. There was an impasse for many months until near the end of the Steering Committee’s tenure, when it agreed upon a compromise of two-yearly screening. This late decision was driven in part by concern that if the Steering Committee were unable to make a unanimous recommendation to government on this matter, government might decide on three-yearly screening on the basis of the economic evidence.
The Steering Committee’s “Options for Change†report debated the merits of establishing a completely new screening programme or of reforming the existing system. 7 The latter was recommended to government as being more likely to have support and, therefore, to succeed.
The recommendations in the “Options for Change†report were accepted by government. The Organised Approach to Cervical Cancer Screening became the screening programme’s formal name and it was progressively implemented from 1991.
Implementing the Change to an Organised Approach
For the first time, a national committee was established with a brief to advise government on policy and operational matters in relation to cervical screening. The National Advisory Committee (NAC) became a forum for energetic debate and change.
Throughout the 1990s, the work of the NAC was greatly assisted by the Commonwealth government continuing to make funds available to State and Territory governments for local efforts. These funds, though small in comparison with the cost to the Commonwealth of the screening programme’s clinical activities, were highly valued and facilitated a range of activities that had not been possible during the 1960s to the 1980s. These activities ranged from recruitment programmes, to the training and credentialling of nurse practitioners, the training of scientists and pathologists for the laboratory work and the support of the Pap Test Registers. Explicit performance indicators in the contracts between the Commonwealth and the States meant the Commonwealth still had considerable power to influence local activities. The provision of local monies for non-clinical activities ensured the continuing involvement of a wide range of players in the screening programme.
Medico-legal pressure also became a powerful influence in the 1990s. A variety of claims were made against pathology laboratories, GPs and specialists. Some successful claims were widely publicised and this brought an added pressure for reform and accountability.
The following are among the major achievements of the organised programme during the 1990s:
- With the adoption of the two-yearly policy, the NAC focussed on establishing a uniform terminology for the reporting of Pap smears and on management protocols for women with abnormal or unsatisfactory Pap smears. 8 Neither of these proved simple to achieve. There was much debate among pathologists about an appropriate terminology system for Australia, with a number of senior pathologists holding different views. A consensus position was not achieved for several years. Because the matter of terminology lay almost exclusively within the pathology community, no other discipline appeared able to assist in achieving a compromise position. The difficulty may have been compounded by this being the first time that many of the pathologists had been asked to agree on a single terminology, their usual work typically being performed in a highly individual fashion. Ultimately, a modification of an international terminology system was adopted and since July 1999 all pathology laboratories have been required to issue their reports using this system.
- After the successful implementation of a Pap Test Register in Victoria during the pilot project phase of 1988–1991, Pap Test Registers were progressively established in all States and Territories of Australia. With hindsight, establishing these registers appears to represent a remarkably bold initiative.
The scope of controversial issues in relation to the Pap Test Registers was very broad, ranging from concern about the diversion of resources away from more pressing matters such as recruitment to concerns about privacy and the possible use of data for purposes other than those relevant to cervical screening. The establishment of a Pap Test Register required either legislative or regulatory change to allow personal information to be held and collated without the signed consent of the woman. Ultimately personal rights were catered for by using an “opt-off†system whereby any woman having a Pap Smear was informed that in the absence of her objecting, the pathology laboratory would pass her information to the local register. There was debate about the appropriateness of sending reminder letters directly to women who were overdue for screening as opposed to sending all reminder letters to the medical practitioner who took the last smear.
Weighing against these concerns was a widespread belief that it was not possible to implement an organised approach to cervical screening without a supporting information system such as a register. The alternative was to restrict Pap smear reporting in each State and Territory to just one laboratory, the records from which would therefore act as a de facto register. Not surprisingly, this suggestion was strongly opposed as it would have meant the closure of many pathology laboratories, most of which were in the private sector.
A critical factor in establishing the Pap Test Registers was their broad coalition of support, which included gynaecologists, pathologists, public health practitioners, women and bureaucrats. No single group was totally opposed to their establishment. Press coverage was generally favourable, with a respected newspaper even offering support via an editorial. 9 Against the pressure being generated, governments felt compelled to act. - The 1990s were characterised by a heightened emphasis on a systematic approach to increasing the level of participation in cervical screening. The establishment of the Pap Test Registers facilitated the recall of previously tested women by providing the means to track and send reminder letters to those who were overdue for their next test. A number of States were also given access to the electoral register for matching against the Pap Test Register. This allowed apparently unscreened women to be identified and sent an invitation for screening.
For the first time in Australia the media – print, radio and television – were widely used to encourage participation. Funding for community development work was provided.
Accurate information about the demographic profile of underscreened and unscreened women became available in a timely and comparatively cheap fashion through the Pap Test Registers and the National Health Surveys. Special programmes were implemented to increase participation from the groups of women identified as being underscreened. - Standard setting. The development and implementation of quantitative performance standards for the pathology laboratories that reported the Pap smears was a major achievement of the organised cervical screening programme. 10 The review of quality assurance activities performed as part of the SECU work in the late 1980s had revealed their fragmentary nature, partly resulting from structural difficulties, whereby even well-motivated laboratories faced daunting obstacles to collecting comprehensive information about the accuracy of their Pap smear reports. By contrast, the newly established Pap Test Registers formed a central database in each State and Territory. For the first time, pathology laboratories could have timely and comprehensive information about the outcome of their Pap smear reports. This allowed laboratories to focus on analysing and interpreting data rather than spending the majority of effort on collecting it.
A subcommittee of the NAC chaired by a Commonwealth Health Department staff member developed, pilot tested and, ultimately, recommended that the screening programme require all pathology laboratories to meet five performance targets. After a lead-in period of three years, the Federal Health Minister made it mandatory from July 1999 for all pathology laboratories that report Pap smears to meet those performance targets. The establishment of these performance targets stands as a major achievement of the organised programme.
Future Challenges
Australia now has a mature organised cervical screening programme. The programme’s success is demonstrated by the declining incidence and mortality rates from cervical cancer. 11 Commitment to the programme is high and broad-based. The essential elements for a successful programme that had been identified internationally in 1986 are mostly in place.
New challenges present themselves and these, like the challenges successfully faced in the 1990s, have applicability beyond cervical screening. I will conclude by briefly describing three of these challenges.
- Cervical screening in Australia has a low cost efficiency. 12 The two major contributors to this are the high proportion of women who are screened more frequently than once every two years and the exceedingly large number of women who undergo treatment for abnormal Pap smears. Neither problem can be easily addressed. In terms of reducing the problem of excessive early rescreening, the choice appears to be between a voluntary conformity to the two-year interval by women and practitioners or a restriction of the government subsidy to one smear every two years. The former will be difficult to achieve because it will require the co-operation of more than 100 laboratories, 20,000 general practitioners, 1,000 obstetricians and gynaecologists and 5,000,000 women. The latter option will be controversial to both women and clinicians. Pathology laboratories could find themselves reporting smears without knowing whether the government will reimburse them for their work or whether they will have to bill the woman. Despite these difficulties, a solution must be found, as it is untenable in the long term to continue spending large amounts of money on inefficient health initiatives.
- Despite the impressive progress made in performance measures for pathology laboratories, there is, as yet, no agreement on what should happen to a laboratory that fails to meet those standards. This issue is being addressed currently. While pathologists’ support for any proposed approach may be given in theory, it is likely this support will be shaken when laboratories become individually vulnerable. Any system adopted must be accountable to both the women of Australia, who need to be able to believe that their Pap smears are being competently reported, and to the pathology industry.
- As with all areas of health care, new technologies are emerging that could challenge approaches. Evidence-based decision-making requires that large multicentred clinical trials be performed to compare the new practices with the old. These will be both complex to deliver and expensive. Unfortunately, many of the new technologies will require evaluation in an Australian setting as it is not possible to rely totally on international evidence because of substantive programme differences between countries. Issues of particular relevance include obtaining agreement on what outcome measures in trials should be, provision for the informed consent of women (given the rarity of the outcome measures, these trials may need to involve hundreds of thousands of women), and the long-term nature of the trial (for example, a trial of vaccination against human papillomavirus to replace Pap smear screening may need to run for more than a decade). For credibility’s sake, proponents of evidence-based medicine must successfully address these and other similarly complex issues.
Looking back over the past 12 years, I believe the three essential ingredients for the successful changes that have occurred include forming and maintaining critical coalitions across diverse disciplines and interest groups, leadership by government, and the provision of funding to trial new approaches. Australia will need to maintain these three ingredients if it is to achieve even more success in its cervical screening programme.
The views expressed in this article are a personal perspective of the author and do not necessarily represent those of her employer or any other body or organisation.
References
- Pund ER, Nieburgs H, Nettles JB, et al. Preinvasive carcinoma of the cervix uteri: seven cases in which it was detected by examination of routine endocervical smears. Arch Pathol Lab Med 1947; 44:571–577
- Coppleson M, Elliott P, Reid BL. Puzzling changes in cervical cancer in young women. Med J Aust 1987; 146:405–6
- Wall Street Journal, 2 November 1987, p. 1
- The report of the Committee of Inquiry into allegations concerning the treatment of cervical cancer at National Women’s Hospital and into other related matters. Auckland, New Zealand: The Committee; 1988
- Editorial. Cancer of the cervix: death by incompetence. Lancet 1985; ii:363–4
- Hakama M, Miller AB, Day NE. Screening for cancer of the uterine cervix. IARC Scientific Publication No 76. Lyon; 1986
- Cervical cancer screening in Australia: options for change. Australian Institute of Health: Prevention Program Evaluation Series No 2. Canberra: AGPS; 1991
- National Health and Medical Research Council. Guidelines for the management of women with screen detected abnormalities. Canberra: AGPS; 1994
- Backing for a vital health measure. The Age, 7 February 1989
- National Cervical Screening Program. Performance standards for Australian laboratories reporting cervical cytology. Canberra: AGPS; 1996
- Breast and cervical cancer screening in Australia 1996–1997. Canberra: Australian Institute of Health; 1998
- Report of the Evaluation Steering Committee. The interim evaluation of the organised approach to preventing cancer of the cervix 1991–95. Canberra: AGPS; 1995
