Screening

Changes at the National Cervical Screening Programme

Changes to the National Cervical Screening Programme (NCSP) came into effect in early March. The changes are aimed at improving the quality, safety and effectiveness of the programmes and are a result of the Health (NCSP) Amendment Act passed in March 2004.

Amongst other things, the new Act allows evaluations and audits of the programme to be carried out without the consent of women whose records will be used in the evaluations. The records available to be used include access by auditors to women's files held by GPs and hospitals.
At the end of February, the NSCP sent a letter outlining the changes to all the women enrolled on the NCSP Register. This letter has become known as the million women letter as there are now over one million women enrolled in the NSCP.
The changes include:

• Making it clear who is responsible for running the programme, how it works and what the responsibilities are for the health professionals involved in it, including smear takers, laboratories and gynaecologists
• Making sure women get the information they need about the cervical screening programme, including their option to withdraw from it
• Changing the NCSP-Register withdrawal option from opting out of individual smears to withdrawing from the Programme as a whole
• Recording and monitoring of all cervical smear results except for those women who withdraw from the Programme
• Allowing access to personal health records by trained evaluators (without the consent or knowledge of the woman) so that Programme can be fully evaluated.
• Providing for regular external independent review of the NCSP

Changes for women wishing to 'opt-off' or withdraw

Women are either in or out of the NSCP now. If you are in, all your results must be recorded on the NSCP-Register. If you 'opt-off' or withdraw, none of your results are included and any results already on the register are destroyed. It is no longer possible to 'opt-off' individual smears.

Women who choose to withdraw from the NCSP do so by filling in the 'Withdraw from the Programme' form (available on the NCSP website: www.healthywomen.org.nz) or by writing to the NCSP asking to withdraw. Women are able to choose whether they want the paper records already on the NCSP-Register returned to them or destroyed. Prior to 7 March 2005 women were provided with a printout of the information held electronically about them on the NCSP-Register when they opted off. However, it is unclear whether this option is still available.

The Federation of Women's Health Councils is consulting with its membership prior to approaching the Director-General of Health, Dr Karen Poutasi, asking that the new process be amended. They want women who choose to withdraw from the programme given a printout of their NCSP-Register information prior to it being deleted. The Federation points out that while this is not a requirement of the new legislation, the law does not prevent the NCSP from doing this.

Information available for women and where to get it

• Pamphlets and booklets ' including Cervical Screening: A Guide for women. Cervical smear tests ' What women need to know. Cervical screening ' Understanding cervical smear test results. Colposcopy ' Information for women who have abnormal cervical smear results. Atawhaitia Te Wharetanga
• Posters ' My body, my health, my future. Atawhaitia Te Wharetanga. Pacific peoples cervical screening poster
• Questions and Answers on the new Act:www.healthywomen.org.nz. Click on the news button
• Fact sheets: 1.About the NCSP, 2. Purposes of the new Act, 3.Enrolment in the programme, 4. Benefits of the programme 5.Evaluation to ensure quality for Women, 6.The NCSP-Register
• Screening Matters newsletter ' a regular newsletter from the National Screening Unit

For further information on any of these resources: phone the NCSP freephone 0800 729 729 or visit: www.healthywomen.org.nz.

Uncertain future for womens health screening in New Zealand

Government has recently announced significant changes to our organised breast and cervical screening programmes. Breast cancer activists and researchers are delighted, so why is Women's Health Action so worried? Jo Fitzpatrick outlines concerns and suggests that proposed changes have the potential to be the nail in the coffin for our screening programmes. After such a difficult history, it seems our screening programmes may face an even more uncertain future.

Working in women's health is sometimes a somewhat dispiriting affair. The last month has been particularly difficult, as changes that we believe threaten the viability of the existing screening programmes have been introduced. For the cervical screening programme, there is the potential for backlash from women choosing to 'opt-off' rather than face the possibility of researchers and evaluators accessing their GP and other personal health records. The issue in breastscreening is altogether different. The age extension downwards to 45 years will put additional stress on an already fragile service. Under 50 years of age, there is clear evidence that the harms of screening outweigh the benefits. The Otago Daily Times editorial (See box: Why the rush?) is a clear-eyed examination of these issues.

The National Cervical Screening Programme

In the November 2003 WATCH, Sandra Coney outlined the proposed legislative changes to the National Cervical Screening Programme and their implications. In March this year the bill completed its third reading in the house and introduced changes which:

• Allow access without consent to all your health records, including GP and personal health care records, if you are enrolled in the programme or if you contract cervical cancer or its precursor. This pernicious little clause means that even if you 'opt-off', your records can still be accessed without your knowledge or consent if you get cervical cancer.
• The new law states that "Every health practitioner must make available, free of charge, to a screening programme evaluator, (¾¾) any health information and specimens that relate to a relevant woman." Making available includes the provision for the evaluator to take copies of all information and records to which the screening programme evaluator has access, ie your GP records.

It appears that Maori women are offered very limited protection through the Kaitiaki regulations. The bill states that it does not affect the Kaitiaki regulations. However, the Kaitiaki regulations deal with release of information on groups of Maori women (aggregated data). The paradox is that this Act will allow access to the records of individual Maori women when evaluators decide that they or their records are relevant to their needs.

The assumption is that the act will only cover evaluation activities designed to improve the quality of service and that only information relevant to this will be accessed. In the Act, evaluate is defined as monitoring and assessing service delivery and outcomes so as to promote the fulfilment of NCSP objectives by determining whether there are any systemic issues to address with the programme or quality improvements that may be made to it. This is what the Act says about what an evaluation may entail:

An evaluation may, from time to time, include a review of, and an investigation into, the cases of

1. Any woman who is enrolled in the NCSP whether or not she has developed any cervical cancer; and
2. Any woman who has developed any cervical cancer whether or not she is enrolled in the NCSP; and
3. Any deceased person to whom 1. or 2. applied at the time of death

Who appoint 'evaluators' and decides on what they do?

Evaluators and their activities are the responsibility of the Director General of Health who may "designate persons on whatever terms and conditions the Director-General deems appropriate.'

A couple of 'feel good' clauses
In order to make us feel better about this, and in a neat little transfer of risk, your health care practitioner is allowed to supervise access by the evaluators to the records held in their data bases. Given the fact that they are required to provide the information 'free of charge', it is unlikely that they will be compensated for time spent on this and unreasonable to expect that they have the resources to build it into their practice. Nowhere in the act is there a requirement to tell you that copies of your records have been included in an evaluation so you may never know.

The other feel-good clause sets up a NCSP Review Committee. The Committee is no more than 3 people appointed by the Minister 'from time to time' but at least once every three years. Their task is to review the operation of the NCSP and any evaluation activities that 'have been carried out or are proposed to be carried out.' and to provide the Minister with a report. The danger is that most of their work will be a retrospective review of evaluation activities already completed or approved and underway. WHA would feel much better about this Committee if it operated continuously with responsibility for setting strategic directions for programme evaluation and had the authority to oversee and approve all proposed evaluation activities. We would also have more confidence in it if there was strong consumer representation mandated as part of its membership.

The role of evaluation
WHA supports research and evaluation to ensure that women are safe within the programme and that standards are being met. The Gisborne Inquiry was more about a failure of the programme to keep women safe than it was about the failure of one person within it. We need mechanisms to evaluate programme components and we accept that access to programme information for individual women is important. What we don't accept is that the only way to do this is to allow evaluators to access your GP records without you knowing, agreeing or being told about it.

There has been a strong lobby to persuade politicians that this is the only solution that will work and that it is necessary for successful evaluation, and the legislation now provides for this. The lobby in favour of this position is made up of researchers and health commissars.

They argue passionately on your behalf that their access to all your health records, without your consent, is the only way to effectively evaluate the programme.
This is rubbish.

The real agenda is that, access without consent opens up undreamt of research possibilities for them. Some of these may benefit you. They are delighted at having unfettered access to huge amounts of health information on women without the inconvenience of having to explain themselves, ask permission or inform the women whose information they want. Earlier versions of this bill suggested that these access provisions be extended to all screening programmes. This bill is the thin end of the wedge. For those of us who remember Cartwright, ghosts of the past hover on future horizons.

WHA is comfortable with provisions which allow access to information held by the register including access to laboratory records and information on the Cancer Registry. These are records women might reasonably expect to be part of their screening programme dossier. Barbara Beckford from the Federation of Women's Health Councils explains their position: 'Many women's groups believe access to primary care records should have an intervening step whereby informed consent is obtained first. Some women might refuse access to personal health records held outside the screening programme but most will agree. The key benefit will be that women will be aware that the audit is happening and there will be a benefit from reviewing aggregated data. If women are offended by the practice of evaluators looking through their personal health records without their consent, the risk is that they will opt off the programme and weaken the public good benefit. Individual women can still have regular smears without threat to their individual health benefit.'
What will women be told?

Currently there are more than one million New Zealand women enrolled on the programme. A review of consumer resources used by the NCSP show that women have consistently been told that their information is confidential. WHA believes that this bill is a breach of the social contract these women signed when they joined the programme. What and how will we be told?

There is a plan to send a letter to all women currently enrolled to inform them of the changes. Womens health groups believe that this letter should not just inform women of the changes and their implications but offer women the opportunity to opt-off the programme and give them instructions on how to do this. This is a huge undertaking and a logistical nightmare. It raises a number of ethical questions around the obligations to inform women, the best way to approach them and the use of public funds and health resources.

Conclusion
Barbara Beckford , co-convenor of the Federation of Women's Health Councils, contends there are more than just scientific values to be considered here. 'How a programme is organised, monitored and reviewed and its transparency and accountability to consumers is critical. The way it involves women in a collaborative partnership is a significant factor to maintain and increase buy-in. The current level of enrolment is already lower than desirable for an effective screening programme. It is simply incomprehensible that the Minister should further compromise this by ignoring women's views on informed consent.'
The Ministry media release (www.csi.org.nz/other_reports/HMA QuestionsnAnswers.htm ) states 'It is well recognised that high enrolment and participation rates help screening programmes to achieve their aims of improving the health of populations.' All screening is a carefully weighted assessment of balance against harm. In the case of cervical screening, the medical benefits outweigh the harms in a convincing fashion. When you identify the obvious precursors to cancer and treat them appropriately, you avoid the development of a life threatening disease and save women's lives.

The tragedy is described by Sue Kedgley in her speech to the house as this bill was introduced : we are 'presenting women in New Zealand with a cruel Hobson's choice. Either they stay on what is otherwise a good and useful programme, surrender their right to informed consent, and allow access to their personal health-care records without their knowledge or explicit consent, or they opt-off the programme and risk their own health and the efficacy of the programme as a whole. 'In fact, women can protect their own health by opting off the programme but ensuring regular screening through their current smeartaker. It is the programme which comes under threat.

A call to action
The Minister has said privately that she is prepared to review the legislation in eighteen months time as she is concerned about the possibility of these measures compromising the programme. The Ministers fears are well founded. WHA has received a number of calls from women who want to take their names off the NCSP register. We have been reluctant to encourage this and have pointed out that it will make no difference if women develop cervical cancer. We support the programme and believe it has much to offer.

Some women are investigating the possibility of working with their GPs to minimise the impact of the legislation. The more dramatic way of doing this is to hold your GP records yourself and take them along to appointments. These are patient-held records and the women looking into this possibility are those who feel very strongly about the issue or who have information on their files that they feel needs to be kept safe. (Most commonly these relate to information on familial family abuse.) The alternative is to ask your GP to place a note on your file stating that the files are not to be accessed without your permission or that, if they are, you are to be told.

Auckland woman Conni Brady is circulating a petition. WHA endorses the general intent of the petition that consent should be obtained to examine primary health records.
For those wishing to take direct action to register their protest at the legislative changes should opt-off the register as soon as possible so that all hard copies of their data will be returned to them. Beyond 12 months after the Act receives the Royal Assent the NCSP manager may retain information in hard copy format that relates to women who cancel enrolment in the NCSP.

Women can re-enrol at any time if they decide that future changes to, or participation in, the screening programme meets their needs. For more information: Phone, fax or email WHA

HIV screening in Pregnancy

When pregnant, almost all women have contact with health professionals. Most women are well and deliver healthy babies. However, between one and four per 10,000 pregnant women is HIV positive and some will not know. The National Health Committee is currently considering proposals to offer HIV screening to all pregnant women. We asked Jo Fitzpatrick about the issues for women.

What is the prevalence of HIV in women in New Zealand?

HIV has been associated with specific at risk groups but this pattern is changing and the HIV-infected population in New Zealand now includes more women. Between 1996 and 2002, 152 (24%) of 640 newly diagnosed cases of HIV were in women. Of course, not all of these women are of childbearing age.

What happens now with pregnant women?

The current policy is to offer HIV testing to women thought to be at high or uncertain risk but this is not well done. Eighty per cent of maternity providers rarely or never assess HIV risk in their antenatal patients because of the personal nature of the questions; a reluctance to cause anxiety in pregnant women; the low prevalence of HIV amongst women; and privacy concerns.3 A similar study in 2001 found that 66% of midwives, GPs and obstetricians in the Upper South Island assessed HIV risk in less than 10% of their patients.4 It would be interesting to see if the results of this study were replicated in regions where there are likely to be greater numbers of people in the high risk population.

What is the high risk population?

Most (over 85%) of the 139 women diagnosed with HIV between 1995 and mid 2002 were infected by male partners and two thirds were infected in Asia and Africa. Of the thirty women to have been infected through heterosexual contact here in New Zealand, nearly half had sexual contact with a male partner from these high prevalence areas. At least another 10 had sexual contact with a partner known to be at risk either through sexual contact with another man or an injecting drug user, often from overseas. 5

Why is it important to identify HIV in pregnant women ?

An average of one in four children born to untreated HIV positive women will contract the infection, and this is preventable. A recent review looked at effective interventions and found that drug therapies (zidovudine and nevirapine) and delivery by elective caesarean section significantly reduce the risk of mother to child transmission.6 The greatest transmission risk is at birth but the NZ guidelines also say that HIV infected women should not breastfeed. However two recent studies7 suggest that all mothers should be encouraged to breastfeed exclusively for the first six months, regardless of HIV status, and then wean their babies rapidly. This recommendation is based on findings that 118 babies of HIV infected mothers exclusively breastfed for the first six months of life had no increased risk when compared to 157 babies of HIV infected mothers who were given no breast milk. Significantly higher rates of infection occurred when babies were both breast and bottlefed and at weaning.

What options are being considered by the National Health Committee for HIV testing in New Zealand ?

1. Voluntary testing offered to women with identified risk factors.
   This is the current system in NZ but it is not being done well. With this approach the test should only be done with the specific informed consent of the woman, which includes pre and post test counselling.
2. Voluntary testing offered to all pregnant women.
   An HIV test is offered to all pregnant women whether or not there are identified risk factors for HIV infection. Specific informed consent and counselling is required. The quality and quantity of counselling before and after testing affect the levels of test acceptability and satisfaction rates.8
3. Routine testing of all pregnant women.
   An HIV test would be added to the standard request form for antenatal blood tests as a matter of routine. In theory, informed consent and counselling are required and women would be able to opt out of the test. The NHC discussion document believes that under this approach women must be notified that an HIV test is included, is considered routine and that they can refuse testing. They also say ¾ there would be no requirement for formalised counselling or written consent. However, the generic expectations to obtain informed consent that is required by the Code of Health and Disability Services Consumers Rights should apply.9
   This is difficult as responsible screening requires a health care system capable of supporting all necessary elements of the screening pathway, including diagnosis follow-up and programme evaluation. The New Zealand College of Midwives currently does not support routine HIV testing in pregnancy as done properly routine HIV testing requires longer and more difficult antenatal consultations and changes the emphasis of care. There is concern about the additional time and training resources needed for maternity care professionals if screening is introduced.10
   Routine screening would involve testing 20,000 30,000 women a year to prevent HIV in one baby. The danger is that HIV screening in pregnancy will become part of the routine bloods. Already there is an admission that: There is a need for a clear review of antenatal blood tests currently offered and the provision of guidelines and education of all New Zealand health providers who might order these tests.11 The danger is that it will be routinely added without womens consent and that the consequences of a positive test only dealt with when this occurs.
4. Mandatory testing of all pregnant women
   While mentioned as an option in the NHC discussion paper, this option is ruled out because it is performed without voluntary, specific and informed consent and without any counselling. If a woman refused the test it would be done against her will and women may avoid antenatal care.

What are the issues for women?

The main issues for pregnant women are around informed consent and counselling. These two issues are related. HIV testing needs to be accompanied by detailed pre-test counselling to assess the risk and examine the consequences of a positive diagnosis to ensure fully informed consent.

For the antenatal workforce, there are questions around the extra resources HIV screening would require. Whatever option is chosen, workforce training and support are needed in how to approach the difficult issues.

Where to now?

HIV is not a women's issue. We need to identify, educate and treat all members of high risk populations. This is a sensitive area and stigmatisation is a risk and a reality. In African communities, the person testing positive first is blamed so it is important to test couples together. Ideally, with systems in place to identify HIV infected people long before conception occurs, we can invest in education around responsible and informed decisions in relation to safe sex and the possibility of conception.

The NHC is considering the report from its Scientific Expert Advisory group12 and submissions to the discussion document. 13 They will then give advice to the Minister of Health for consideration.

References

Full references are available from Women's Health Action. Email: info@womens-health.org.nz .

[CHPR] Fact Sheet Released on Cancer Screening Rates Among Asian Ethnic Groups - November 2003

A new fact sheet from the UCLA Center for Health Policy Research, titled "Cancer Screening Rates Among Asian Ethnic Groups," finds that, within the Asian population, ethnic subgroups differ substantially in their receipt of cancer screenings at recommended intervals. In additional, screening rates for cervical and breast cancer are generally lower for members of Asian ethnic groups with limited English proficiency. Using data from the 2001 California Health Interview Survey (CHIS 2001), the fact sheet examines cancer screening rates for cervical cancer (Pap test), breast cancer (mammogram), and colorectal cancer (fecal occult blood test, colonoscopy, or sigmoidoscopy) among Asian ethnic subgroups.
This fact sheet also examines cancer screening rates among adults with limited English proficiency.
Key findings from this fact sheet include:

* Cambodian and Korean women have rates of screening for breast cancer that are far below the average rate for California.
* Less than 40% of Cambodian and Korean men and women over the age of 50 report a recent colorectal cancer screening.
* Among Chinese women, the proportion reporting a Pap test is significantly lower for limited English proficient (LEP) women than for English proficient women.
* While 63.8% of English proficient Korean women report a mammogram in the past two years, this rate drops to 45.4% among those with limited English proficiency.

A copy of the fact sheet can be downloaded at http://www.healthpolicy.ucla.edu/pubs/publication.asp?pubID=82