Informed Consent in screening programmes

This is a copy of the paper presented by Ms Coney at the following workshop

Healthy Women Workshop Education & Training for Health Promotion

National Cervical Screening Programme and BreastScreen Aotearoa, Health Funding Authority

Sandra Coney Executive Director, Women's Health Action Trust

.Napier 23 June 2000

This important meeting of women involved in the breast and cervical screening programmes is taking place at the same time as the Gisborne Inquiry. The Inquiry is not just looking at missed smears at Gisborne, but the health of the whole screening programme. The stories of women have revealed problems at all levels and the difficulties women have had accessing information.

The lesson we have to take from the problems at Gisborne is that screening programmes are very hard to do. People don't always recognise this, they see screening as simply doing tests on women without recognising the challenges an organised screening programme presents.

Screening as a social contract

In screening we promise women we will make a difference. So we have obligations to all the women who take part. Thousands of women must take part in programmes to prevent a single case of cervical cancer or to prevent a single premature death from breast cancer. Many women will go through the anxiety and trauma of being recalled for further assessment, then be given the all clear. All women who take part in programmes risk a personal cost, even in the best run of programmes.

Screening programmes can be viewed as a form of social contract in which large numbers of women agree to participate to ultimately benefit a very few. We owe it to these women to ensure that they make a fully informed decision to participate and that the standards reached in programmes is high. We can only know that after thorough ongoing monitoring and evaluation. After a decade, this has not occurred in cervical screening and it is too early to know whether the processes put in place in breast screening will guarantee standards and goals for the programme are met.

Role of health educators

Health educators have a key role in addressing these challenges because they are often at the front line encouraging women to take part in screening and in giving women the information on which they choose whether to be screened.

A key concept in screening is that of the screening pathway that starts with inviting women to take part and ends with the treatment of women who have been found to have disease. We need to strive for excellence at every point along the pathway so that it is safe to invite women to take part.

This is not just the responsibility of those in health agencies organising programmes, but of all the people working in the programme. To act ethically, when we invite women we have to know that standards have been set at every level and that those standards are monitored to make sure that they are being met. Health educators need to be involved in setting standards, developing policy and ensuring that monitoring takes place.

This means being advocates for the programme and for women, and being political when we need to be. We need to make sure women can communicate with us when they have problems, and we need to be powerful enough to feel confident about taking up these issues on behalf of women and making sure they are resolved.

Reaching women

The health promotion concept that underlay the National Cervical Screening Programme was of a women-oriented programme. This means a programme organised around women's needs, one that is women centred but initiated by providers. Unless programmes are organised this way, they simply will not work as women will vote with their feet and stay away.

There will always be a core group of women who will attend for health checks without much prompting. These women tend to be educated and in higher socio-economic groups. Involving women who have other things that are more central in their lives, such as survival, is much more difficult. Women may have other values that they give priority over preventive health checks. When women do take part they often want to be confirmed as healthy, whereas screening is a hunt for disease. Research in cervical screening in New Zealand and overseas also shows that some women resist the implication of screening that they are sick.

This may be the point that some lead providers is breast screening have reached when they report that the numbers of women attending have fallen off. The Gisborne Inquiry has been blamed, just as increased numbers of abortions have been blamed on informing women about blood clots on the Pill.

Neither is true. Nationally collected data shows that the total number of women on the Pill stayed the same after the Pill scare, but that women shifted from the high risk Third Generation Pills to the safer, Second Generation brands.

The experience of cervical screening failures is that more women come forward to have smear tests as a result of such publicity, rather than fewer. The media coverage acts as a prompt, rather than making women think it is a waste of time.

Informed consent in screening

Screening failures such as Gisborne and those that have occurred overseas have led to soul searching about what we tell women when we invite them to take part. We have to remember that screening programmes internationally got underway in an era when there was not a great deal of thought about informed consent. The first cervical screening programmes started in the 1950's and they organised smear-taking activity that was already very widespread. The trials on which breast screening is based occurred in the 1970's and 80's.

In New Zealand we have prided ourselves on being ahead of the world on consent. The Nation Cervical Screening Programme has emphasised consent from the earliest days, but when you go back and look at the education materials, you will see that the emphasis is on consent to enrolling on the register and the programme, rather than consent to cervical screening itself.

We have the Code of Health and Disability Services Consumers' Rights which lays out what constitutes consent. However, the Code is not entirely adequate for screening. Screening differs from the usual relationship between providers and users of services in that the consumers are not sick people seeking treatment. They are well people who are invited by others to take part.

In the UK this has been formally recognised and special guidelines for informed consent to screening have been issued by the General Medical Council, the equivalent of our Medical Council. These guidelines stress that there are many uncertainties in screening and that some findings may have serious medical, social and financial consequences for individuals and their relatives.

Thus, said the Council, it is important that people make properly informed decisions and that providers ensure that screening will not be contrary to the person's interest. The information that the person wants or ought to have must be provided.

Informed consent would involve information about:

• the purpose of screening
• the likelihood of false negatives and false positives
• the uncertainties and risks of screening
• the significant medical, social or financial implications
• follow up plans including the availability of counselling and support services.

There is a need for such formal guidance in New Zealand, not just for medical providers, but for all health workers involved in screening. Women's Health Action has raised this with the Ministry of Health and with the new Health Commissioner. The Ministry has asked the Medical Council of New Zealand to comment and seems favourably disposed to the issuing of guidelines. Eventually we would like to see consent guidelines for screening included in the Code, or if not there, in guidelines of some sort as well as in standards for screening.

The uptake mentality

Consent in screening is not a straightforward area. There is an inherent tension in screening that has not always received a great deal of attention, but has, internationally, recently come under critical review.

This is the desire for screening programmes to reach targets for screening coverage to ensure they reach their goals. Sometimes these targets are tied to incentives, including financial incentives. People are paid for smears taken, or women who have mammograms.

In capitated primary medical care models such as New Zealand is moving towards with Labour's Primary Care Strategy, targets can be performance measures built into contracts.

If we take informed consent seriously, performance measures should relate to the provision of services that give women the opportunity to make an informed choice to take part, rather than actually having the intervention.

Target approaches can lead to an 'uptake mentality' where the goal is getting as many women participating as possible. Women are 'recruited', as if it is a religious mission or a marketing drive.

Health education materials can be biased towards stressing only the positive aspects of screening so as not to raise questions and reduce coverage. The prevailing paternalistic assumption is that screening is beneficial and that consumers should be persuaded to take part for their own good.

Health education theories that have been popular in the past have also undercut informed consent. Models such as the 'health belief model', which was first proposed in the 1960's, describes the progression of steps that occurs in a person's thinking before she makes behavioural changes around health care. Health education interventions based on the health belief model try to change a person's behaviour by exploiting anxieties about health. The aim is to encourage people to adopt what others consider beneficial behaviours.

This approach is out of date in the year 2000.

It does not recognise the autonomy of individuals. It does not observe people's human rights. It does not recognise that communities are diverse and that the values of individuals and groups may differ from those of the organisers of programmes.

Information needs of women

What has happened at Gisborne reinforces the need to ensure that women have sufficient information to make their own decisions about taking part. Internationally there has been increasing recognition about the possible harms and failures of screening. These are:

• Anxiety, for those recalled, but even for those simply invited to take part
• False negatives where women have a clear test but actually have abnormalities or disease.
• False positives, where screening tests suggest a problem where none exists
• Over-diagnosis and over-treatment where women receive treatment for conditions which may have not have progressed or which may have regressed.
• Some women have treatment but develop recurrent disease.
• The psychological cost of labelling people as having an illness
• The certificate of health effect where a negative screen reinforces an unhealthy lifestyle.

There has been a tendency not to tell women about these negative aspects. Indeed some providers are very resistant to doing so on the grounds that it may put women off. There are opponents of telling women about standards that have been set by programmes. They maintain these will not be of interest to women or that they are a provider matter.

Information about standards will not be of interest to all women, but that is not a reason not to offer it. It is up to women to decide the level of information they want. For some women, such as those being referred for further assessment, standards are important, as they provide valuable information which women can use to protect themselves, such as waiting times for colposcopy, or the qualifications of the person reading mammograms or performing the ultrasound.

Recently Women's Health Action has carried out a project on cervical screening educational resources for the National Cervical Screening Programme and the Health Funding Authority. This has involved a review of both local and international literature on resources, looking at the existing resources and redeveloping the colposcopy resource. What stands out, despite over 40 years of providing programmes, is the lack of adequate information given to women to make informed choices.

Internationally women have not been given adequate information and New Zealand is no different. Smear tests are usually described as able to prevent cervical cancer, or, at least, the most common form of cervical cancer. But there is virtually no information about the limitations and risks of screening or even explicit information about the benefits.

It is common in both cervical and breast screening to gloss over the discomfort, even pain of the test, especially for particular groups. For instance, postmenopausal women commonly find a smear test painful, they may bleed after it, yet they are not told about it. To experience these without warning, will be more off-putting for women than being frank about what they may expect beforehand.

Some of the information that women need is very hard to find.

It is even difficult to find what the benefit of cervical screening is. In fact the benefit is substantial. Women having regular smears reduce their risk of dying from cervical cancer by over 90%. This is a very significant benefit and contrasts with the benefit of regular breast screening which is around 25 to 30%. Of course breast cancer is a more common disease, especially in older women.

The first step for women making a choice about whether to be screened is to understand their underlying risk, yet this is an area where women have a very poor understanding and screening programmes make very little attempt to enlighten women.

The average 20-year-old woman has about a 250 in 10,000 chance of developing cervical cancer and about a 118 in 10,000 chance of dying from it. Regular screening at least every three years from 20 to 75 years reduces the risk of developing cancer by about 215 in 10,000 and the risk of dying by 107 in 10,000. The average 50-year-old woman has a one in 42 chance of dying of breast cancer before she turns 75. Regular screening reduces this risk to one in 60. *

Information given to women about the benefits of screening tends to talk in terms of relative risks, but overseas research, as well as home-grown research, conducted in Wellington, has shown that people take different understandings from benefits framed as relative risks, compared to risks framed as absolute risks. A 50% reduction in disease will have a different meaning if the disease is common, compared to if the risk is rare.

All these concepts are quite difficult to understand and even more difficult to convey, but if we are to undertake screening we must finds ways of conveying this information. While information should be conveyed simply in the first instance, women must be able to access more in-depth information easily, whether it is through health educators or health education materials such as detailed booklets and web sites.

Reaching quality standards

When we offer benefits, there are also issues around whether, in practice, we can measure up to the results that have been reached within the organised randomised controlled trials that have formed the basis of New Zealand programmes. Standards have been set in breast screening, and we know what has been achievable overseas, but only experience will show if we are able to reach them. In the meantime we are promising women results we do not know if we can achieve. This is of course what has happened in cervical screening. Women were promised the benefits of an organised programme, but the programme failed to carry out the necessary work. Under-staffing and under-resourcing were issues as well a general failure to recognise the science of screening programmes at a planning and a political level.

Disclosing the screening pathway

This also requires disclosing to women the potential repercussions of taking part in screening. There has been a tendency in breast and cervical screening to inform women just about each step at a time, to seek consent only the screening test. Having a smear or a mammogram is just one step on the screening pathway. For women who are recalled, there will be other decisions to be made. It is a critical part of informed consent for women to know about the entire screening pathway and the possible things that might occur before they take the first step. This is a complex form of informed consent because it requires potential participants to be able to imagine themselves in situations that might occur before they are faced with them.

This is important for consent but it is also important to prepare women for the possibility of an abnormal result and for recall. In research on screening programmes women have consistently said that they want more information and they want information at the time of the initial screening test about the meaning of an abnormal result and what will happen after that.

Lack of understanding of screening

Another challenge of health education is that people do not understand screening well. I am not aware of any research in New Zealand, but in Australia national research by the Anti-Cancer Council of Victoria found that people had difficulty distinguishing mass screening from treatment of disease. They found that 68% of people had heard of screening tests but only 21% understood that screening tests were for asymptomatic people. Research in the US and New Zealand has shown that women over- estimate how effective mammography screening is.

People tend to see screening as much more precise than it is and they tend to interpret a positive result or recall as a verdict of cancer. The challenge is to educate women so that they understand that screening is not a precise art, it is simply about dividing people into groups of people who are unlikely to have disease or who possibly have disease.

The partnership approach

Behind any successful programme is the concept of partnership or co-ownership when women feel they have a stake in a programme, that it is a joint enterprise with providers then they are more likely to take part. The health promotion principals of

• building healthy public policy,
• creating supportive environments,
• strengthening action,
• developing personal skills
• and reorienting health services

are critical to the success of screening programmes.

The principles of the Treaty of Waitangi are just as relevant and these have been emphasised at this workshop.

A partnership approach means working with communities of women not imposing services on them from a medical focus.

There has been a move internationally to reinforce a partnership approach to health care. In New Zealand women have been actively promoting this model for some decades and this was given a great boost by the Cartwright Inquiry.

Evidence-based consumer information

Sharing information underlies the partnership approach. A partnership approach must take into account the movement for evidence based health care which includes recognition that information for consumers should similarly be evidence based.

This is seen as consistent with the rise of consumerism, greater recognition of human rights and an emphasis on preserving individual autonomy.

The movement for evidence based consumer information is new and there are reports that both consumer interests and providers can have difficulty with it. Consumers, because the evidence may conflict with long held beliefs, and providers for the same reason as well as a reluctance to share all information with consumers. A first step for health educators is to be clear themselves about the evidence behind the information they are giving. That involves a self-responsibility as well as one to women, to keeping up-to-date with the science behind the intervention being offered.

Various overseas researchers have begun to define what evidence based patient choice means. One group has proposed the following three criteria for evidence based consumer choice:

1. The decision is about which health care intervention or pattern a person will or will not receive
2. The person concerned is given researched-based information about the effectiveness including likely outcomes, benefits and risks of at least two alternative interventions which may include the option of no intervention.
3. The decision is in some way shared between the health professional and the consumer.

These criteria have been designed for treatment choices but they are highly relevant to screening choices.

Conclusion

All of us who promote screening for women do so believing that it will benefit women. We must not use that belief to persuade, pressure or instruct women to take part. Our role is to provide the best information and environment for women to make their own choices.

Our role is to be advocates for women in ensuring that programmes deliver on their promises. We must reduce barriers to screening but finally we must respect the freedom of women to make their own choices. If we can achieve that we will have done our jobs.

* The figures for cervical screening were taken from Eddy DM (199) Screening for cervical cancer Ann Int Med 113: 214-26. The figures for breast screening were worked out by Dr Brian Cox for the BreastScreen Aotearoa resource More about breast screening and the National Breast Screening Programme, and are based on women who have screening from 50-64 years of age.