Data privacy and informed consent: A recap of the debate over draft NICE guidelines on fetal alcohol spectrum disorders
Health guidelines for England and Wales are expected to be finalised in the next year, providing much-needed direction on the diagnosis of fetal alcohol spectrum disorders. Yet, after two rounds of consultation, vociferous objections from women’s organisations, and a delay due to COVID-19, it is still far from clear what the final text will look like. Natalie Davies discusses the potential implications of the guidance below.
Dr Raja Mukherjee runs the only clinic in England for fetal alcohol spectrum disorders (FASD) – a group of lifelong behavioural, cognitive and physical disabilities caused by prenatal exposure to alcohol. He has warned that FASD is “hidden in plain sight”, and unless we start looking for it and diagnosing it, people with FASD and their families “will continue to be affected by a lack of support”. If his words were a call to action, they seem to have been heard. There has been significant movement towards addressing the ‘diagnostic deficit’ in the past few years.
In 2019, the Scottish Intercollegiate Guidelines Network (SIGN) published guidelines on “Children and young people exposed prenatally to alcohol”. These were complemented by a number of diagnostic tools for clinicians, including an FASD assessment form, a diagnostic flow chart, and a neurodevelopmental pathway. In 2020, the National Institute for Health and Care Excellence (NICE) followed suit, issuing draft guidelines for commissioning and providing FASD services in England and Wales. In the case of the NICE guidance, however, enthusiasm for its clinical steer on FASD was arguably overshadowed by concerns that women’s rights were being overlooked or sacrificed.
Greater focus on proving prenatal alcohol exposure
Diagnosing fetal alcohol spectrum disorders is “complicated”. The distinctive facial features once relied upon for diagnosing FASD are now understood to only affect a minority of people. The neurodevelopmental problems associated with FASD can overlap with other conditions, such as autism spectrum disorders. In most cases, FASD may be a diagnosis of exclusion, rather than an open-and-shut case.
“Diagnosing FASD is complicated, and there is no specific test for the condition. Identification is through recognition of expected characteristics while ruling out the impact of other causes that may better explain the presentation.” Department of Health and Social Care
One way to try and un-complicate this complicated issue is to shift focus to proving prenatal alcohol exposure – in other words, to document women’s alcohol consumption throughout their pregnancy (from conception to birth).
Scottish guidelines agree that “A reliable and accurate maternal alcohol history is the best screening tool for identifying risk of FASD”. But they also suggest that evidence of drinking during pregnancy is not enough to justify investigations for FASD. This is because, while alcohol is the sole cause of fetal alcohol spectrum disorders, it does not always cause fetal alcohol spectrum disorders.
In the UK, alcohol is consumed in an estimated 41% of pregnancies, which puts a large proportion at theoretical risk of FASD. The number of people in the general population thought to have FASD is probably much lower (although still uncomfortably high) at around 6%, with the figure rising considerably among children in the care system. While there is no ‘safe threshold’ for alcohol consumption in pregnancy, and there are many potential consequences beyond FASD (e.g. miscarriage and premature labour), this gap between those exposed to alcohol in utero and those with FASD suggests that proving prenatal alcohol exposure would be a blunt instrument for diagnosing alcohol-related harm in pregnancy.
Major changes in anticipation of harm
There is little evidence that low levels of alcohol consumption during pregnancy will cause harm to the developing embryo (first eight weeks after implantation) or fetus (nine weeks after implantation until birth). However, the draft NICE guidelines make the assumption that any alcohol consumption comes with a sufficient level of risk to justify major changes to antenatal care.
“Antenatal appointments allow questions on alcohol consumption to be asked as part of routine healthcare throughout pregnancy. The timing, quantity and frequency of alcohol use should be recorded in maternity records and then transferred to the child’s health records after birth.” National Institute for Health and Care Excellence
Almost in anticipation of harm or a negative outcome, the proposed NICE guidelines advocate repeatedly enquiring about alcohol consumption in all pregnancies, noting any and all disclosures down on women’s medical records, and putting a system in place to transfer this information to the child’s medical records after birth.
When so much about a child’s life chances can be determined before birth, there is a strong argument for ensuring that medical history pertinent to the start of the lifecourse follows the child. However, what the draft guidelines stated would have serious consequences for women’s reproductive healthcare and women’s rights, and it is not clear that this was given adequate (or indeed any) consideration.
An incomplete equality impact assessment
The recommendations in the NICE guidelines appear to oblige midwives and other clinicians to screen for alcohol use throughout pregnancy, and do so without making any reference to the principle of informed consent (i.e. screening is something women should be informed about, and know that they have the right to opt-in or opt-out).
The recommendations in the NICE guidelines also appear to waive a woman’s right to medical confidentiality, by routinely sharing medical information with another patient and their healthcare providers. Although there are cases for disclosing medical information that affects another patient without prior consent, this applies where there is risk of death or serious harm, and neither would be the case in the context of these guidelines, where: (a) harm has not yet been demonstrated: and (b) proving alcohol consumption during pregnancy would not prevent death or serious harm.
None of these issues appear to have been discussed as part of the equality impact assessment for the guidelines. There was no mention of women. There was seemingly no consideration of the fact that women’s antenatal care would change, and their basic expectation and right to medical privacy would be compromised.
Focusing on the outcomes of the fetus
The only equality issue that was identified and addressed in the development of the guidelines was the difficulty in accessing appropriate care and support for children in the care system. This refers to the fact that it can be considerably more difficult for adoptive and foster families to get a diagnosis of FASD as they may not have any information about the biological mother’s drinking during pregnancy.
“Identifying children at risk of fetal alcohol spectrum disorder (FASD) depends on accurate recording of a mother’s alcohol consumption during pregnancy. A lack of this information is a barrier to a diagnosis of FASD […] This is particularly important for children no longer with their biological mother (such as adopted children and looked-after children).” National Institute for Health and Care Excellence
The equality impact assessment stated that NICE would “ensure that the mother’s alcohol consumption in pregnancy is recorded in the maternity notes and on the child’s health records”, in order to “alleviate barriers to, or difficulties with, access to services and thereby advance equality in access”.
The assessor’s view of equality was disappointingly incomplete. There was no mention of ‘women’, ‘sex’, or ‘gender’, which perhaps at least gives a useful window of insight into the development of the guidelines.
The guidelines were manifestly focused on the outcomes of the fetus, with little regard for the woman who carries the pregnancy. Speaking to Radio 4 in September 2020 about this, Clare Murphy, Chief Executive of the British Pregnancy Advisory Service, said, “Women don’t lose their right to medical privacy simply because they’re pregnant.” However, when guidelines deviate from the standard of woman-centred care in pregnancy, this may indeed be what’s at stake.
Screening in antenatal care
Women typically see their midwife more than any other healthcare professional during pregnancy, and “being a midwife is more than just delivering babies”.
“A midwife is usually the first and main contact for the woman during her pregnancy, throughout labour and the early postnatal period. She is responsible for providing care and supporting women to make informed choices about their care.” Royal College of Midwives
Midwives already routinely enquire about alcohol consumption – along with other lifestyle factors that could affect a woman’s overall health and wellbeing, as well as her pregnancy. For women who continue to drink during pregnancy, midwives are well-placed to offer advice, to deliver brief interventions aimed at helping them reduce their drinking or stop drinking altogether, and to refer them for specialist treatment and support if they have a drinking problem.
According to the draft NICE guidelines, midwives and other clinicians would be expected to repeatedly enquire about alcohol consumption, whether or not there is concern that women are still drinking or are causing harm to themselves and their pregnancies. The enquiries would not be prompted by the aim to reduce alcohol-related harm across the population, as with brief interventions. They would principally be to document evidence for a hypothetical future when a child and their family might need a diagnosis of FASD. It would be to document harm that women have potentially caused to their pregnancies.
Midwives are very skilled at having sensitive conversations with women about issues ranging from domestic abuse, to mental health problems, to pregnancy loss. This requires them to develop a relationship based on mutual trust and support with their patients. If women fear that there will be consequences based on what they say to their midwife, they may be less inclined to speak openly, which would not serve the goal of preventing alcohol-related harm, or any other kind of harm, during pregnancy.
The Royal College of Midwives raised concerns about this during the consultation period on the NICE guidelines. The national voice for midwifery advised that the “proposed approach could cause women to be stigmatised, or cause self-stigmatisation, and may disrupt or prevent the development of a trusting relationship between a woman and her midwife”. They also cautioned that “the proposal may be self-defeating, as women who are in most need of help will feel the need to conceal the consumption of alcohol from their midwife.”
Who is really ‘at risk’?
While working to improve the diagnostic pathway for FASD in Scotland, the guideline development group were mindful of the need to make recommendations that were manageable in a clinical context. Their 2019 guidelines recommended that “a referral should not be made in the absence of accompanying physical or developmental concerns in the child or young person”. In practice, even disclosures of “significant amounts of alcohol during pregnancy” would not be sufficient to trigger an investigation for FASD. There had to be evidence of severe impairment. Without this, there could be “unmanageable increases in inappropriate referrals”.
The draft NICE guidelines on FASD also identified the need for diagnoses to be driven by clinical concerns, such as physical, developmental or behavioural difficulties in children and young people. However, the preceding recommendations suggested keeping extensive notes about all women’s drinking habits in pregnancy, in order to support future diagnoses of FASD. As the guidelines did not specify a baseline level of consumption, the implication is that all pregnancies exposed to alcohol (including a single glass of wine) signal a risk of FASD.
Colleagues in Canada have been very clear that there should be a threshold for a referral for a diagnosis of FASD, and for them that threshold is ‘exposure to alcohol at levels associated with physical or developmental effects’. This is obviously far removed from the example of a single glass of wine, and is useful as it shows how potentially wide (or small) policymakers can cast the net.
Doing more, but not necessarily doing the right thing
There is legitimate concern that, as a society, we are not doing enough to support those affected by fetal alcohol spectrum disorders. However, experts in Scotland have noted the absence of “[sufficient] relevant evidence of adequate quality” to guide clinicians on the identification of children at risk of FASD and criteria for diagnosis. The fact is that we need to do more, but we’re acting in a dearth of evidence.
Nonetheless, we can at least expect new guidelines to pass the test of proportionality (i.e. that the ends justify the means; that the action suggested is not excessive in relation to the goal it is serving).
The draft NICE guidelines arguably fail to demonstrate that the recommendation to record pregnant women’s alcohol consumption is a proportionate response. If implemented, the requirement for women’s alcohol consumption to be recorded throughout pregnancy and transferred to the child’s records after birth would bring a huge number of women and pregnancies under unnecessary scrutiny. This could cause needless distress and unintended consequences. It would undermine women’s expectations of, and rights to, medical confidentiality. And, it could compromise the ability of midwives to provide women-centred antenatal care.
Experts are right to point out that there is no known ‘safe’ level of drinking during pregnancy. The same is also true for the general population – there is no universally safe level of drinking. The difference, of course, is that drinking guidelines for pregnant women are principally driven by the impetus to protect the fetus from harm. The draft NICE guidelines were also principally driven by what was perceived to be best for the fetus, with little to no consideration for the pregnant woman.
Up to at least 2014, the position of the Royal College of Obstetricians and Gynaecologists and National Institute for Health and Care Excellence was that women should not drink at all during the first 12 weeks, and thereafter should limit consumption. Today, the advice is less equivocal. Across the board, official UK guidelines advise women who are pregnant or could get pregnant to abstain from alcohol (1 2 3).
Now it is becoming apparent that this shift from an informed-choice approach to a precautionary abstinence-ony approach had a ripple effect beyond public health advice. The draft NICE guidelines on fetal alcohol spectrum disorders operationalised the judgement that any alcohol in pregnancy confers a risk to the fetus, and in doing so, rendered ‘risk’ a nebulous concept. It arguably moved us further away from (not closer to) a scientifically-informed approach to addressing FASD, and supporting women to have healthy pregnancies.
Much like the rest of the population, pregnant women make decisions all the time based on an assessment of risk. This includes whether or how much to exercise, what to eat, and whether to be vaccinated. It includes whether to have a glass of wine, and whether to tell your midwife about it. Risk in pregnancy is ever present, and navigating risk is hard enough without expert guidance muddying the waters.
This article was published as part of The Pregnancy Edit for September 2021. If you are interested in writing a blog or participating in an interview about alcohol-related harm in pregnancy for the SSA website, please contact Natalie Davies at email@example.com.
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