Prenatal Screening: Undue Influence?



Prenatal Screening: Undue Influence?

Dr. James B. Robins MB ChB MPhil MRCOG

Consultant Obstetrician & Gynaecologist

Inverclyde Royal Hospital,

GREENOCK PA16 0XN

Tel: 01475 633777 Ext. 4512

Fax: 01475 656188

Email: James.Robins@irh.scot.nhs.uk

Introduction

Prenatal screening for fetal abnormality, and in particular Down syndrome, has become in the eyes of the Government, the public, the media and health service professionals alike an acceptable part of antenatal care. Yet there are harms that may arise from the offering of these tests. Whilst concerns regarding quality, effectiveness and reliability are regularly debated in the press and medical journals, other issues surrounding prenatal screening such as discrimination, coercion, loss of individual autonomy, and interference with reproductive choice have often been neglected.

Over deference to the scientific aspects of screening and the legitimising of technological innovation, have eroded individual rights to self-determination and autonomy. Of some concern has been the recent introduction of a series of initiatives to modernise antenatal screening that include moves to introduce routine first trimester screening for Down syndrome. The customary offering of this service within the antenatal care package reinforces compliant behaviour and presumes acceptance.

A presumption of acceptance…

Prenatal screening for Down syndrome is unusual as a medical service in that its value does not lie in managing or curing illness but instead in producing information that generates difficult choices for the patient. The information required to make these decisions is complex and technical, contrasting relative risks and involving terms and ideas that are not part of the everyday experience of the woman. Despite an intended neutrality the very act of offering Down syndrome screening, (be it serum screening, nuchal translucency measurement or both), intrinsically puts forth the assertion that possession of this knowledge will be beneficial and empowering.(1) In other words the potential damage of mandatory offering is that women can experience the process of receiving the offer of a test as compulsion. Women come to perceive screening for Down syndrome as an integral part of antenatal care and feel a responsibility to have it. (2)

…and an expectation of compliant behaviour

Recently a group of midwives from Sheffield have described ‘compliant behaviour’ in the antenatal setting.(3,4) Their studies suggest that inequalities in power and status in the maternity services have a greater influence on what happens to women giving birth than either their hopes and dreams or the choices that they feel informed to make. An offer that is made under conditions that take advantage of a woman’s vulnerabilities, when she is hoping for good care and attention and does not want to be seen to disappoint her obstetrician, midwife or general practitioner, does not respect her voluntariness. The woman may fear covertly expressed suggestions of rejection by the professional staff when she wants to be seen to be doing the best for her baby; her resistance is weakened by her desire for the complete antenatal care package, (which is after all almost entirely organized around the provision of prenatal screening tests – in itself a presumption of acceptance).

The woman’s participation in the decision-making process and ultimate choice regarding the administration of a screening test must be voluntary. The decision as to whether or not to be screened should rest on knowledge of potential benefits but remain free from social pressures and coercions. Yet how many simply acquiesce to meet the terms of the service provided?

Provision of information is only one of the necessary conditions – and not a sufficient condition – for informed choice in the context of health care. Competence, (of patients to understand choices), voluntariness (freedom from constraints and coercion), and decision-making ability are also necessary. (5)

Most antenatal patients are competent but in the context of pregnancy care in the United Kingdom it is doubtful whether all decisions are truly voluntary.(5) The real issue in this situation is whether the ‘informed’ choice is freely made. (6)

Consent and the requirement for voluntariness

In traditional medical practice patients ask doctors for advice and treatment for their complaints. The doctor’s duty is to do only that for which the patient has given consent. Screening for asymptomatic or occult disease differs from this: the contact is initiated by health care providers who seek out people who believe themselves to be well with an offer to optimise their future health. By offering to screen, however, the doctor assumes the same duty of care as if the patient had initiated the contact.(7)

Failure to obtain consent for a screening procedure is not only ethically unacceptable but also exposes the provider to the risk of litigation. A subject who has suffered unpleasant or hazardous procedures as a result of a screening test, or who was wrongly reassured by a false negative result, might bring a successful action if she can show that the nature and limitations of the screening process had not been adequately explained or that the test had not been correctly performed.(7)

To give a valid consent subjects must understand the nature of the screening process. In the context of antenatal screening the consequences of a positive screening result must be explained. These can be serious, entailing invasive investigations and possibly culminating in the loss of a normal infant because of a false positive result or a complication of the diagnostic procedure. In addition there is the possibility that a false negative result may be followed by the birth of a severely handicapped child with disastrous emotional and legal consequences. In this regard the Scottish case of McLelland v Greater Glasgow Health Board provides a recent example of a successful claim.(8)

There are three criteria that fall to be determined for legally valid consent to exist and all must be present. Firstly we have to consider whether the patient had both the competence and capacity to give consent. Then we have to ensure that the person giving consent was appropriately informed prior to making a decision. Lastly, the question of whether the consent was voluntarily given arises.

What is voluntariness?

In the context of consent, "voluntariness" refers to a patient's right to make treatment decisions free of any undue influence. A patient's freedom to decide can be impinged upon by internal factors, such as anxiety, or by external factors. External factors include the ability of others to exert control over a patient by force, coercion or manipulation.

Typically, force requires the use of physical restraint or sedation to enable a treatment to be given whereas coercion involves the use of explicit or implicit threats to ensure that a treatment is accepted. Manipulation, however, involves the deliberate distortion or omission of information in an attempt to induce the patient to accept a treatment.(9) Issues of coercion and informational manipulation can arise in prenatal screening and in these circumstances voluntariness may be compromised.

Obviously, the requirement for voluntariness does not imply that clinicians should refrain from persuading patients to accept advice. Persuasion involves appealing to the patient’s reason in an attempt to convince her of the merits of a recommendation. Reasoned argument is never an unjustified form of influence. The goal in this situation is simply to avoid overwhelming the person with frightening information. In attempting to persuade the patient to follow a particular course of action, the clinician still leaves her free to accept or reject this advice.

Voluntariness is grounded in several related concepts, including freedom, autonomy and independence. Legally and ethically the principle of autonomy of the individual is central to any consideration of voluntariness. (9)

Autonomy & voluntariness

There are three primary concepts in the theory of autonomy: competence, freedom and respect. (10) A woman is autonomous if she is competent to make decisions about how she ought to live her life, is free to do so and is respected as an individual within society.

Autonomy involves competence or ability to rule one’s self. (11) Yet, although necessary, competence alone is not sufficient for an individual to be deemed autonomous. In addition to having the ability to formulate a life-plan an individual must also have the freedom to carry out that plan. A fully autonomous individual is free from both the controlling interferences of others and any personal limitations that may prevent meaningful choice.

It is this ability to act free from controlling influence that has been termed voluntariness. As already considered, freedom from external influence is a matter of degree.(12) However, in addition to freedom from control of others there is also the concept of internal freedom. A woman lacks autonomy if she allows intrinsic forces to subjugate her ability to reason. Thus a free individual is one who is free from both extrinsic forces such as deception and intrinsic forces such as fear, pain or discomfort. Autonomous persons typically consider the freedom to act as no less important than adequate understanding.

The final component of autonomy theory is respect. In order for a particular individual’s autonomy to flourish, other individuals and society as a whole must respect that autonomy. Respect for autonomy obligates professionals to disclose information to probe for and ensure understanding and voluntariness and to foster adequate decision-making.

Thus, when considered within the principle of autonomy, voluntariness may be better expressed in the statement “that a person acts voluntarily to the degree she wills the action without being under the control of another influence”.(12)

The legal significance of voluntariness

The ethical principle that each person has a right to autonomy finds its expression in law through the legal concept of consent,

“The fundamental principle underlying consent is said to be a right of self determination; the principle or value of choice of autonomy of the person… It is an ethical principle which is simply reflected in legal rules because our law has been developed by judges sensitive to the practical application of generally held community ethical principles”.(13)

The law has long recognized that a consent or refusal coerced by threats or manipulated by misrepresentations is invalid and seeks to protect autonomy by ensuring that a person’s decision is the product of her freely self-chosen and informed plan.

The terms “voluntariness” and “voluntary choice” are used in connection with matters relating to criminal proceedings – typically, and as in R v Gregory,(14) in relation to the defence of duress. Fortunately, duress, compulsion, force and deception are not usually features of medical practice. However, it would be wrong to forget that there are situations in which coercion may at least hover, typically when medical care is given in prison institutions.(15)

For example, an element of coercion is implicit in the prison doctor-patient relationship. In Freeman v Home Office (No.2),(16) an argument was advanced on behalf of the plaintiff, a prisoner serving a life sentence, who claimed that he had received medical treatment against his will. Freeman claimed that not only had he not consented but also that there were certain contexts in which consent could never be voluntary. It was agreed that whatever the circumstances the issue of voluntariness is a fact but, in the absence of overt coercion, the restricted circumstances in which a prisoner’s consent to treatment is given would be unlikely to affect the validity of that consent in law. However;

‘a court must be alive to the risk that what may appear on the face of it to be real consent is not so’.(16)

But when voluntariness is defined in such a way as to take account of the more subtle pressures to which patients may be exposed, there may be a role for the law in drawing a line between the permissible and the impermissible.(15) In drawing the line it is helpful to note that there are two contexts in which a claim of lack of voluntariness could arise. Firstly the patient may claim that she was treated after a consent that was improperly gained. Alternatively it may be alleged that the patient’s refusal or provision of consent was the consequence of improper pressure.

The English case of Re T (adult: refusal of medical treatment) has established the legal context in which voluntariness should be analysed in relation to medical practice.(17) In Re T the Court of Appeal recognised that for the most part claims of lack of voluntariness do not involve brute force or duress, instead the pressure may be more insidious.

The Court of Appeal in Re T applied a well-recognised and understood doctrine from contract law, that of ‘undue influence’. In applying this doctrine the Court widened the scope of the influences or circumstances that could render a patient’s consent invalid. This is because ‘undue influence’ is a more devious and subtle process than overt pressure and therefore calls for closer examination of the facts.

Re T concerned a young woman’s refusal of consent and whether it was voluntary in view of the influence exercised over her by her mother. The case stands as clear authority that involuntariness can be proved by evidence of undue influence as well as the more obvious examples of circumstances that might overbear the will of the patient. As such the case should be explored in more depth. However, it is first appropriate to briefly outline the concept of ‘undue influence’ that arises in contract law. The standard of ‘undue influence’ is a further example of how law flows from the theory of autonomy.

Vitiating Factors in Contract Law

There are a number of factors that may affect the validity of a contract even though the contract appears legitimate. These are known as ‘vitiating’ factors and normally arise from the circumstances in which the contract was made or from its purpose. Vitiating factors include error, misrepresentation and illegality. However, particularly relevant are the issues of force and fear, facility and circumvention and most importantly ‘undue influence’. They can be considered within the structure applied earlier to external factors affecting voluntariness – force, coercion and manipulation.

Obviously consent obtained by threats of, or actual, physical violence is in the eyes of the law, no consent at all and any contract obtained by such means will be void. The rule of force and fear extends to threats to close relatives and even threatened loss of employment.

The subtler concept of facility refers to frailty or weakness of mind that falls short of insanity but makes a person vulnerable to manipulation and as such would normally be considered an internal factor. Illness, old age, stress or bereavement might bring about this state of mind. It may be temporary or permanent but because it does not amount to insanity it does not remove capacity to contract. It is always considered in association with circumvention. Circumvention is misleading behaviour that falls short of actual fraud.(18) The combination of facility and circumvention can render any contract voidable at the instigation of the victim but there are few decided cases with MacGilvray v Gilmartin a rare modern example. (19)

Undue influence

Influence that prevents someone from exercising an independent judgment with respect to any transaction is considered undue influence. A contract or gift procured by the exercise of undue influence is liable to be set aside by the courts. The exercise of undue influence must normally be proved affirmatively – it must be shown that there is a dealing or transaction in which an unfair advantage has been taken of another person. Undue influence may, therefore, be difficult to prove directly.

However, a presumption of undue influence is made as a judicial tool when certain characteristics are present. Typically, and as established in Gray v Binny,(20) a confidential relationship exists in which one party is in a position of superiority over the other. When the relationship between the parties is such the contract may be voidable at the instance of the weaker party. Typically there will be some element of trust or confidence between the parties but no fraud or deceit, merely influence. Paradigmatic examples include the doctor-patient, lawyer-client and trustee-beneficiary relationships. These are confidential relationships where one person is dependent on another. In these circumstances it is argued that the vulnerable party may be susceptible to the influence of the dominant party. The dependent person may not be free from the control of the influencer because of her dependency. Undue influence does not require that the victim has facility, only that she has been improperly influenced.(18)

A classification of cases of undue influence was adopted by the Court of Appeal in Bank of Credit and Commerce International SA v Aboody, (21) and was quoted with approval by Lord-Browne-Wilkinson in Barclays Bank plc. v O’Brien.(22)

Class 1: Actual undue influence. In these cases it is necessary for the claimant to prove that the wrongdoer exerted undue influence on the complainant to enter into the particular transaction that is impugned.

Class 2: Presumed undue influence. In these cases the complainant only has to show that there was a relationship of trust and confidence between the complainant and the wrongdoer of such a nature that it would be fair to presume that the wrongdoer abused that relationship in procuring the complainant to enter into the impugned transaction. Once a confidential relationship has been proved, the burden then shifts to the wrongdoer to prove that the complainant entered into the impugned transaction freely. Such a confidential relationship can be established in two ways;

Class 2(A): Certain relationships (solicitor and client, medical adviser and patient) where as a matter of law the presumption is made that undue influence has been exercised.

Class 2(B): Even if there is no relationship falling within Class 2(A) if the complainant proves the existence of a relationship under which the complainant usually reposed trust and confidence in the wrongdoer then the existence of such a relationship raises the presumption of undue influence.

Further qualifications to the standard of undue influence have been proposed. It is, for example, accepted as a general principle that actual undue influence may be exercised by the concealment of material facts.(23)

In Aboody it had been held that in all cases of undue influence it was necessary for the plaintiff to prove that the transaction was manifestly disadvantageous to her. However, in CIBC Mortgages plc v Pitt, (24) the House of Lords held that a plaintiff who proved Class 1 undue influence did not require also to prove that the transaction was manifestly disadvantageous although that requirement remained in Class 2 cases.

It has also been presumed that a necessary element of a case of undue influence was that the influence was brought to bear for the benefit of the person exercising it. However the cases of Allcard v Skinner,(25) Bullock v Lloyds Bank Ltd.,(26) and in Scotland Allan v Allan,(27) suggest that this is not a requirement and both the pursuers and the defenders in the more recent case of Isabella Doris Briggs or Broadway v Clydesdale Bank plc. ,(28) accepted that personal benefit gained by the person exercising the undue influence is not an essential feature of a case of undue influence.

Having now established the legal concept of undue influence we should return to the case of Re T to establish how this doctrine was applied to a non-contractual civil wrong.

Case Law: Re T (adult: refusal of medical treatment)

This was the first adult Jehovah’s Witness case to come before a British Court. In brief, Miss T, a pregnant woman at 34 weeks gestation, was involved in a car accident and after speaking with her mother, signed a form of refusal of blood transfusion. Following caesarean section and delivery of a stillborn baby, her condition deteriorated and a court order was obtained legalizing blood transfusion on the grounds that it was manifestly in her best interests.

The Court of Appeal held that there was no valid refusal of blood transfusion by Miss T and the appeal was dismissed. The Master of the Rolls, Lord Donaldson of Lymington and Lord Justice Butler-Sloss further held that Miss T had been subjected to the undue influence of her mother which vitiated her consent. Lord Justice Staughton, however, felt that cases on undue influence in the law of property and contract were not directly applicable in this context.

Lord Donaldson MR first outlined the history of case and all relevant details. Having made some comments on capacity to decide he went on to explain the vitiating factor of outside influence. This he considered was a special problem that may arise if, at the time the patient makes a decision, she has been subjected to the influence of another (third) party. It is relevant to consider whether the patient really means what she says or is she merely agreeing ‘for a quiet life’ or to satisfy someone else, or because the advice and persuasion to which she has been subjected is such that she can no longer think and decide for herself. In so doing he asked the question:

“Is it a decision expressed in form only, not in reality?” (29)

Lord Donaldson suggested that when considering the effect of outside influences there are two aspects that are of crucial importance. First he reflected on the strength of will of the patient. One who is very tired, in pain or depressed will be much less able to resist having her will overborne than one who is rested, free from pain and cheerful. Secondly the relationship of the persuader to the patient may be of singular importance.

“When considering the effect of outside influences, of crucial importance are the strength of will of the patient and the relationship of the ‘persuader’ to the patient”.(30)

He felt it wholly acceptable that the patient should be persuaded by others of the merits of the decision and have decided accordingly. Persuasion is a legitimate strategy provided it does not overbear the independence of the patient’s decision. Yet, persuasion based on religious belief was felt to be particularly compelling.

Lord Justice Butler-Sloss followed the argument laid out by Lord Donaldson. She considered that the intervention of the mother, who was alone with her daughter immediately before each of the two occasions when Miss T indicated her rejection of blood transfusion, was a most relevant factor in the appeal. In her decision she gave a more detailed account of the line of probate cases that had considered undue influence.

In doing so she agreed with Staughton LJ that the neither the probate line of cases nor the donor lines of cases was directly appropriate to the case in question. However, she contended that the decisions were helpful to demonstrate both at law and in equity that;

“it has long been recognized that an influence may be subtle, insidious, pervasive and where religious beliefs are involved especially powerful”.(31)

She thus came to the same conclusion as Lord Donaldson MR; namely that there was abundant evidence to justify the conclusion that Miss T was subjected to the undue influence of her mother, thus vitiating her decision.

Lord Justice Staughton also dismissed the appeal and agreed with Lord Donaldson MR and Butler-Sloss LJ that there was no valid refusal of consent, and that the doctors were justified in their treatment of Miss T under the principle of necessity. He did not follow the undue influence argument;

“The cases on undue influence in the law of property and contract are not, in my opinion, applicable in the different context of consent to medical or surgical treatment”.(32)

However, the decision of all three judges was clearly considered in this context.

The implications of Re T.

This case has become a ‘benchmark’ for consent. It has established the absolute right of the competent adult to refuse life-saving treatment – an authority applied in the later case of Re C. Per Lord Donaldson MR;

“an adult patient who suffers from no mental incapacity has an absolute right to choose whether to consent to medical treatment, to refuse it … or choose one rather than another of the treatments being offered … this right of choice is not limited to decisions which others might regard as sensible”.(33)

The decision also made it clear that in the case of an adult patient, no other person, not even next of kin, has an automatic legal right to consent to or refuse consent to treatment.

However, Re T was in essence a piece of legal artifice. In effect the Court transformed involuntary treatment of a competent adult into non-voluntary treatment by the principle of necessity with ‘outside influence’ being taken into consideration.

Yet, the question remains as to whether the case really did decide the definition of undue influence within the context of medical litigation. One of the problems with Re T is that it concerned the influence of a third party, an individual out-with the doctor-patient relationship. Mason and McCall-Smith consider that neither Lord Donaldson nor Butler-Sloss LJ make it any easier by including parents and religious advisers among those who might, as a result of their relationship, lend themselves more readily than others to overbearing the patient’s will.(34)

It may be that the courts will be more eager to see lack of voluntariness when the patient is defying rather than agreeing to medical advice. Yet, now the test has been developed it cannot be limited to refusals only. Unlike Re T, most questions involving voluntariness arise in situations when it appears that the patient consented but the patient alleges that the consent was not freely given.

Voluntariness in other legal jurisdictions

Unlike the case of Freeman the Michigan Circuit Court saw the institutional setting as crucial in the case of Kaimowitz v Michighan Dept. of Mental Health.(35) Whereas it is often said that in Freeman the court dismissed the argument that the ‘institutional setting’ deprived him of his free will too readily, the court in Kaimowitz may have been over-protective. They applied Nuremberg Standards that require experimental subjects to be situated as to exercise free power and choice without the intervention of an element of fraud, force, deceit duress or other form of constraint or coercion. The court determined that involuntarily confined mental patients are not able to give informed consent because of the inherent inequality in their position.

Etchells and colleagues have reported on some earlier Canadian cases that consider issues surrounding voluntariness.(9) In Beausoleil v. Sisters of Charity,(36) a young woman about to undergo spinal surgery repeatedly requested a general anaesthetic and refused a spinal anaesthetic. After the patient had been sedated, the anaesthetist convinced her to have a spinal anaesthetic. The patient was subsequently paralyzed as a result of the procedure and successfully sued the anaesthetist. In testimony, a witness said that the patient;

"refused [the spinal anaesthetic], but they continued to offer it to her; finally she became tired and said: 'You do as you wish' or something like that".(37)

The judge stated that the patient's agreement to the spinal anaesthetic was involuntary, because it rested on

"words that denote defeat, exhaustion, and abandonment of the will power".(37)

Although predating Re T it is a clear example of Lord Donaldsons description of ‘a decision expressed in form only, and not reality’.(29)

Likewise in Ferguson v. Hamilton Civic Hospitals et al.,(38) there were issues regarding the timing of consent. In this case a patient unsuccessfully sued for battery after undergoing an angiogram that resulted in quadriplegia. Although the suit was unsuccessful, the court was critical of the circumstances in which the consent was obtained and suggested,

"the informing of a patient should occur at an earlier time than when he is on the table immediately before undergoing the procedure”.(39)

Clearly obtaining consent just before a major procedure is problematic because the setting and the immediacy of the medical procedure militate against a patient being able to make a free or voluntary decision. Similarly the way in which information is presented or a professional’s careful choice of words or nuances of tone and emphasis might present the situation in a manner calculated to heighten the appeal of a particular course of action.(9)

Voluntariness & prenatal screening

“It is my opinion that clients are more often bullied than informed into consent, their resistance weakened in part by their desire for the general service if not the specific procedure, in part by the oppressive setting they find themselves in, and in part by the calculated intimidation, restriction of information and covert threats of rejection by the professional staff itself”.(40)

To what extent can the definition of voluntariness arrived at in Re T be applied to prenatal screening? It would be highly misogynistic to suggest that pregnancy results in temporary facility; pregnant women are not incapable of sufficient understanding as a consequence of their condition. Yet, the pregnant woman may not be completely self-determining; she may be vulnerable under the circumstances that relate to the medicalization of her pregnancy.

There is good evidence that social pressure can undermine the principle of informed and voluntary consent.(41)

“The worry about direct coercion was misplaced, but that did not mean influence was absent. Not at all. Social pressure soon turned into a routine ‘medically indicated’ procedure, as common and standard for a woman over the age of 35 as taking blood pressure. It takes a tough and determined woman these days to exercise the ‘free-choice’ of not choosing prenatal diagnosis … here, as elsewhere, social pressure can accomplish quite nicely and smoothly what could never be legislated directly”.(42)

Of further concern in antenatal screening, (and central to the ethical debate at the heart of all screening programmes), is the nature and use of the information provided. All information has value; information is not ethically neutral. With prenatal screening this information is presented as ‘risk’, a concept that is often difficult to grasp but one which all too readily implies vulnerability, susceptibility, jeopardy or hazard.

Gifford has argued that the ambiguity of an ‘at-risk’ result creates a state of being that is somewhere between health and disease.(43) For women, finding out that they were at risk had an iatrogenic effect, transforming a normal healthy pregnancy into a quasi-disease state that required further action to reinstate a sense of well-being.

Thus one of the central questions that requires to be answered is the issue of whether or not the woman is really in a position to give consent to a fairly technical procedure that provides an indication of ‘risk’.(41) Because it is the consequences of the action taken by the woman, (on the basis of the ‘risk’ information provided), that invoke moral consideration, the processes that go into obtaining and presenting that information become important.

These and other issues relating to voluntariness and prenatal screening can be explored by considering the recent development of first trimester Down syndrome screening strategies.

First Trimester Screening for Down Syndrome

It is becoming clear that screening for Down syndrome through ultrasound measurement of nuchal translucency (NT) during the first trimester has some value. Adding the measurement of serum pregnancy associated plasma protein A (PAPP-A) and the free ß-subunit of human chorionic gonadotrophin (FßhCG) at this time increases the sensitivity of first trimester screening to as high as 80%. This procedure is known as the first trimester combined test.

Pressure is currently being mounted by enthusiasts for either a first trimester combined test or an integrated test, (that involves both the first trimester combined test and second trimester serum screening), to be made available on the NHS.

“we have to perform these tests on a privately funded basis. The NHS will not pay for first trimester testing…it is a proven area and it is wrong not to make it available to pregnant women”.(44)

These strategies have been assessed, analysed and compared with respect to the effects, safety and cost effectiveness of the procedures involved.(45) The traditional outcome measures have been employed; uptake of the test, number of live born babies with Down syndrome, miscarriages due to amniocentesis, healthcare costs of screening and additional miscarriages per additional affected life birth prevented.

One such initiative has been the Scottish Combined Ultrasound and Biochemical Screening in Pregnancy (CUBS) project. This was a study to evaluate the use of a combination of ultrasound measurements of fetal nuchal translucency and other appropriate biochemical markers as a first trimester screening test for Down syndrome and other fetal abnormalities in a routine antenatal clinic setting. A total of 15 Scottish maternity units participated and 17,229 patients attending between 10 and 14 weeks gestation were recruited to the study over a two-year period.

Ultrasound nuchal translucency (NT) measurements were attempted in each pregnancy using a standardised protocol and blood and urine samples were collected for analysis of PAPP-A, FßhCG and the urinary markers ßhCG and urinary gonadotrophin peptide (UGP).

The full results of this study have recently been published.(46) Forty-five cases of Down syndrome were ascertained in the study group, (2.6/1000). Overall the detection rate for Down syndrome based on NT and maternal age was lower than previously reported. In this study NT and age combined would have detected 54% of the Down syndrome cases at a 5% follow-up rate. The addition of serum markers, however, results in a substantial increase in detection with 82% of Down syndrome cases ascertained for a false positive rate of 5%. This detection rate exceeds that reported for more traditional second trimester serum screening protocols, (typically 65-70%). CUB screening also has the potential to deliver a screening result to pregnant women around 4 weeks earlier than second trimester screening.

There are, however, problems associated with the introduction of this new screening technology. Recently a considerable amount of effort has gone into devolving maternity care to the community setting. Community midwives first see a significant proportion of maternity patients at home or in outlying clinics. However, due to the requirement for high quality ultrasound imaging and skilled scanning staff, all women wishing to have CUB screening will have to attend a hospital-based antenatal clinic. This is totally against prevailing attitudes to pregnancy care. In addition the need to attend a hospital antenatal clinic within the 11-13 week window will also mean that a proportion of the pregnant population who wish to have screening will present too late to their doctor.

Even so the hospital departments failed to obtain a single NT measurement in more than 27% of the pregnancies scanned. Yet the investigators felt that they had good reason to believe that this performance would improve in routine practice when results are being given to all patients.

Specifically they argued that these problems could be resolved by re-organizing the provision of a maternity service: antenatal attendance schedules can be altered to compensate for any deficiencies. For example, increasing the amount of time available to the sonographer to complete the nuchal translucency measurement will increase the percentage acquisition. There are obvious resource implications - for a booking population of 3000 women this would amount to an additional 9 hours per week of scanning time.

But in reshaping the service provided we presume that patients want to participate in this screening without actually seeking their consent. There is an expectation of compliant behaviour.

The fact that an ultrasound scan is performed as part of the screening process is a crucial factor. An ultrasound scan may be difficult to refuse. Women look on it as a pleasant and positive event. Serum screening is far more often connected with the finding of disease or abnormality than an ultrasound scan.(47) It has been suggested that one way to facilitate informed choice is to separate ‘scanning’ (to monitor the pregnancy) from ‘screening’ (for fetal anomalies) but this is not always feasible.

Obviously more time is required for counselling. However the test is introduced to women by midwifery staff at their first prenatal appointment at the same time as a general health history is obtained and when routine information about the remainder of the woman’s prenatal care regime is being provided. The option to undergo screening may be sandwiched between discussion of other blood tests, which are ’routine’ but often not presented as voluntary.(48) The nature of the interchange may make a clear assumption that the test is going to be done. Furthermore constraints of timing put pressure on women to make a decision. Both the setting and immediacy may mitigate against the woman making a fully voluntary choice. It is known, for example, that many people accept cystic fibrosis testing offered immediately but do not return on another day for the same free test.(49)

Enhanced provision of written information is particularly important when a new screening test is introduced since the risk of compliant behaviour is highest at this stage.(50) The enthusiasts explain that information is provided before the clinic visit. However, when prior information is sent it accompanies the usual routine documentation. The fact that the information comes in this way further legitimises the test – the maternity unit itself is seen to endorse the testing. Previously published literature on MSAFP uptake implies a direct relationship between a commitment to screening by the health care providers and higher rates of acceptance by women.(48)

There are other practical issues and some of these warrant consideration. For example, by participating in this screening there will be a tendency for some cases of spina bifida to be missed, as maternal serum AFP measurements are no longer part of the screening protocol. Ensuring that all women who have CUB screening also have a second trimester MSAFP test and a detailed ultrasound scan at 20 weeks gestation can provide protection against loss of NTD detection but only by further medicalizing the pregnancy. Lastly the hope that early diagnosis would allow the ‘less traumatic’ option of a first trimester abortion has not been realized.

The practical issues are one thing but does this strategy offer real choice?

Can there be a ‘real choice’?

“That is the worst thing about being a middle-class woman…you have more knowledge of yourself and the world: you are equipped to make choices, but there are none left to make”.(51)

Simplistically it might seem unarguable that the new technologies do offer increased choice but a real choice demands an element of control. Control is predicated on the availability of information and the power to contribute to the ways in which services are offered and organized.(52)

A study, conducted in Glasgow by Grewal and colleagues, assessed women’s knowledge of the antenatal serum screening test and the implications of the results.(53) Two thirds of women surveyed knew that serum screening was undertaken for Down syndrome risk and 81% for spina bifida. Half the women were unaware that a positive result could occur without abnormality or that a negative result could be falsely reassuring. Socio-economic deprivation was associated with a poorer knowledge but not lower uptake. Once again the conclusion that can be taken from this study is that high uptake rates of antenatal screening reflect compliance rather than knowledge.

“Advocates often argue that these technologies do, in fact, bring women new options and choices. But … have pointed out that any discussion of rights and choices assumes a society in which there are no serious differences of power and authority between individuals. Where power differences do prevail, coercion (subtle or otherwise) is apt to prevail”.(52)

Perhaps prenatal screening is an offer that is extremely difficult to refuse. The current ‘opt-out’ system of routine screening achieves high rates of use but only at the expense of informed choice for some participants.(54) Counselling inevitably contains a directive element because of the nature of the information covered and women participate in prenatal screening for a variety of reasons.(55) In a recent survey of almost 1000 women reassurance was the personal reason most often mentioned and nobody mentioned the finding of specific diseases or abnormal conditions as a personal reason for participation.(47)

Maybe this is not the complete picture. Most research on prenatal fetal testing in general, and MSAFP screening in particular, has focused on women who accept and even actively seek prenatal diagnosis. Perhaps one of the consequences of this approach is that the results have suggested that agreeing to prenatal screening is inextricably linked to the processes associated with the medicalization of reproduction and that most women do not see refusal as an option.

Voluntariness as a legal issue in prenatal screening

The issue of voluntariness received detailed consideration by the President’s Commission in the 1983 Report ‘Making Health Care Decisions’.

“Since voluntariness is one of the foundation stones of … consent, professionals have a high ethical obligation to avoid coercion and manipulation of their patients. The law penalizes those who ignore the requirements of consent or who directly coerce it, but can do little about subtle manipulations without incurring severe disruptions … and so the duty is best thought of primarily in ethical terms”.(56)

Could voluntariness become an issue in the courts? So far Re T has not been applied to prenatal screening. Yet there are scenarios in which a woman could claim that she received prenatal screening without her consent and they do not necessarily require the birth of an abnormal child. Dr. Josephine Venn-Treloar, a general practitioner assistant from London described her personal experience of ‘covert’ first trimester screening in the British Medical Journal. She clearly felt that screening for nuchal translucency had been performed without her consent.

“I believe that many mothers attend for ultrasound diagnosis, believing that the test is designed to confirm that the baby is well. It is only when they are presented with an abnormal scan result that they start to consider what it means. By that time they have already been offered advice on amniocentesis and are well on the way to an abortion”.(57)

Her experience heightened her awareness of the ethical problems surrounding antenatal testing. This issue was debated further in the correspondence that followed. It emerged that although most women are enthusiastic about having an ultrasound scan this is because they do not directly associate scans with screening as they might a blood test.(58,59)

Some respondents, however, suggested that ultrasound scanning is just an extension of the consultation and if done properly the patient would be under no pressure to choose an option contrary to her beliefs,

“By presenting themselves for consultation or ultrasound scan patients indicate that they are willing to have the examination. To insist on written consent would slow the process considerably”.(60)

Surely, in the context of first trimester screening for aneuploidy this view is no longer tenable. Whilst adding a component to a routinely established process will not always affect the attributes of that process, the effect of any change is context dependent. With nuchal translucency scanning the aim and the purpose of the ‘dating’ ultrasound examination is changed. The variation in the procedure is sufficient to invalidate the patient’s prior consent to routine booking investigations.(61) Specific consent should be sought for these procedures.

Of course, undue influence can work in the other direction. A well meaning midwife, obstetrician or general practitioner with strong religious conviction and anti-abortion beliefs may encourage rejection of the screening test – a situation where Re T would perhaps be of more direct relevance - as indeed would the circumstances where a woman is unduly influenced by her partner to either accept or reject screening.

Conclusions

It is widely agreed that the decision about whether to undergo prenatal screening should be made by the pregnant woman on the basis of good information.(62,63) Prenatal screening choices are primarily a matter for private decision-making. There is no moral problem when a competent person understands the implications and risks and voluntarily consents to a procedure that doctors can provide in good conscience.

Yet, and as we have seen, prenatal screening is difficult to introduce in a way that guarantees informed choice for all women. Priority has been given to implementing the practicalities of testing and there has been little attention paid to appropriate counselling. If prenatal screening tests are introduced into clinical practice adequate resources should be allocated to ensure that healthcare workers will have the time to take into consideration each woman’s personal situation when giving counselling about the nature of the screening tests and possible diagnostic tests.(47)

With regard to the newer techniques that extend Down syndrome screening into the first trimester, these programmes should be regarded as research procedures until their value and safety are firmly established.(64) More importantly there should also be evidence that the complete screening programme is socially and ethically acceptable to health professionals and the public.(65)

Whilst high uptake rates of first trimester screening have been equated with the screening service being viewed very favourably by women, (66) it remains to be seen whether uptake under conditions such as this results in the most informed choices.(67) The potential for coercion, for disvaluing and for discrimination is a feature of our not too distant past. The pressures on women may have become subtler, less overt, and more technological but it would be naïve to insist that they have simply and miraculously vanished.

Clearly there is a difference between deciding for women - either overtly or covertly - in their ‘best interests’ and deciding in partnership with women at their request. Shakespeare suggests that rather than evaluating screening programmes in terms of the number of individuals who undergo diagnostic testing or terminate affected pregnancies, evaluation is better made in terms of the proportion of people who were able to make a free and informed choice about their pregnancy.(68)

JBR 2002

It was a pamphlet produced by Prof. Jim Thornton that provided the original idea for this dissertation. I am grateful to him for not only supplying the concept but for continuing to challenge my values and beliefs. Thereafter, Prof. Priscilla Alderson provided early help and instruction. Prof. Sheila McLean maintained the impetus with constant advice and encouragement. Without her supervision and guidance a coherent argument would never have emerged.

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