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Understanding Mordel: obtaining informed consent for trisomy screening

02 February 2021
17 min read
Volume 29 · Issue 2

Abstract

The landmark decision of Montgomery has established that the patient's right to self-determination and autonomy underpins the doctrine of informed consent. The case of Mordel threw into question the process of obtaining informed consent and whether it was being sufficiently secured in the context of Down's syndrome screening. This case conveyed a paradigm shift to the role of the midwife and sonographers when obtaining consent for screening and the requisite legal standard of care they owe to expectant parents. However, many key issues remain unanswered from the decision in Mordel, in particular, what steps must healthcare professionals take to discharge their duty of care in the process of securing informed consent from expectant parents for screening.

Screening for fetal anomalies during the antenatal period remains a controversial issue in midwifery and reproductive health practice. The traditional ‘Down's syndrome’ antenatal screening pathway is currently going through a period of significant development across England and Wales. Between 2016–2018, following the UK National Screening Committee ([UK NSC], 2013) recommendations, both NHS England (2017) and Wales implemented the new ‘trisomy’ screening pathway (Antenatal Screening Wales, 2019).

‘Trisomy’ is the medical term used to describe the presence of an additional chromosome in some or all of the cells of a person. For example, trisomy 21, or Down's syndrome, is characterised by an additional chromosome 21. Under the new pathway, Down's syndrome (trisomy 21), the most common chromosomal condition detected antenatally would be joined by the second and third most commonly detected chromosomal conditions, Edwards' syndrome (trisomy 18) and Patau's syndrome (trisomy 13), to form the ‘trisomy’ screening pathway.

Modification to the screening pathway was also accompanied by the introduction of a new method of screening. This new method of screening is called non-invasive prenatal testing (NIPT). NIPT was introduced as a safer and more accurate method of screening for trisomies, circumventing the 0.5%–1% risk of procedural miscarriage associated with invasive diagnostic testing, such as amniocentesis and chorionic villus sampling (Alexander et al, 2015; Wulff et al, 2016). This was implemented by the NHS in Wales in 2018 (Antenatal Screening Wales, 2019); however, it is still in the process of being implemented by NHS England.

The introduction of Edwards' and Patau's syndromes to the pathway could warrant a restructure of the established process for obtaining informed consent from expectant parents. In England and Wales, expectant parents have the choice to screen for Down's syndrome only, Patau's and Edwards' syndrome together only, or all three conditions together (Antenatal Screening Wales, 2019; Fetal Anomaly Screening Programme, 2019). While these conditions are also ‘trisomies’, they are entirely different from Down's syndrome in aetiology, pathogenesis and prognosis. The inclusion of Edwards' syndrome and Patau's syndrome into the screening pathway will mean that counselling parents on informed choice and consent will vary significantly depending on which conditions they decide to screen for (Antenatal Screening Wales, 2019; Fetal Anomaly Screening Programme, 2019).

Ultimately, the role of midwives and all healthcare professionals is to respect autonomy and promote informed decision-making (Ahmed et al, 2013). However, the ideal and the reality are not often realised in practice. Cernat et al (2019) performed a systematic review and qualitative meta-analysis to explore the experiences of women in relation to informed choice in the context of NIPT. This study showed a lack of satisfaction towards the process, highlighting that the quality and quantity of information they received during counselling was not satisfactory (Cernat et al, 2019). The research demonstrated the individuality of women's personal circumstances in how they receive information, and the need for improved information-sharing and counselling (Cernat et al, 2019).

The addition of NIPT to the screening pathway could have an impact on the healthcare professionals duty to obtain informed consent from expectant parents (Nuffield Council, 2017; Brownsword and Wale, 2018; Antenatal Screening Wales, 2019). A concern exists that the purpose of NIPT is not being sufficiently explained, resulting in a misunderstanding amongst expectant parents that it is diagnostic due to its high rate of accuracy, quoted at 99% in various medical studies (van de Heuvel et al, 2009). The misrepresentation that NIPT is an alternative to invasive testing (amniocentesis) may result in consent not being fully informed, hindering reproductive autonomy (Silock et al, 2015).

The case of Mordel v Royal Berkshire NHS Foundation Trust (2019) threw into question the process of obtaining informed consent, and whether it was being sufficiently secured by healthcare professionals in the context of Down's syndrome screening. It is highly probable, as a consequence to the transforming landscape of the new trisomy screening regime, that the courts will be confronted with a case of this nature in the near future unless pre-emptive action is taken. It is essential that we explore the amended duty imposed by Mordel onto midwives and sonographers who play an integral role in obtaining informed consent for trisomy screening.

The symbolic significance of Mordel (2019)

The case of Mordel was very emotive, highly publicised and divisive. Due to the sensitive nature of the case, labelled ‘wrongful birth’ by the press, it was widely criticised by the general public, including Down's syndrome campaign groups. However, the ruling was timely for the purposes of illustrating the vulnerability of those healthcare professionals when required to obtain the expectant parents' informed consent for trisomy screening.

Facts

In 2015 (under the old Down's syndrome screening pathway), the baby Aleksander Mordel, was born with trisomy 21 or Down's syndrome (Mordel v Royal Berkshire NHS Foundation Trust, 2019). It was Mrs Mordel's first pregnancy. Mrs Mordel sought damages for clinical negligence against the hospital (Royal Berkshire Trust) as they had negligently missed two opportunities to perform screening for Down's syndrome which, had this taken place, she would have terminated the pregnancy (Mordel, 2019).

The precise course of events was that Mrs Mordel attended her booking appointment (23 June 2014) and had ‘accepted’ all six methods of screening, which included the combined test commonly used as a method of screening for Down's syndrome in the first trimester (Mordel, 2019). Mrs Mordel was booked in to have her nuchal translucency (NT) scan a month later (22 July 2014) which forms part of the combined screening (Mordel, 2019). Mrs Mordel arrived at the hospital to have her 12-week dating scan performed but the sonographer reported, on the basis that she selected the drop-down computer options, that the Down's syndrome screening – a measurement of the NT – had been declined (Mordel, 2019). An overall health check of the baby was still performed at the 12-week scan. Mrs Mordel also declined having her bloods taken which would have formed the other part of the combined test (Mordel, 2019). Therefore, both aspects of the combined test – NT measurements and bloods – had been declined (Mordel, 2019).

A month later (11 August 2014), Mrs Mordel returned to see the midwife but the quadruple test (second trimester screening for Down's syndrome) was not offered (Mordel, 2019). Mrs Mordel did undergo the 20-week fetal anomaly scan but this was considered unremarkable (Mordel, 2019). This is not used as a recommended method of screening for Down's syndrome as it is not sufficiently accurate to identify the condition. A caesarean section was performed and Aleksander was born safely.

Issues

There were six key issues for the judiciary (Mordel, 2019):

  • (a) Did the sonographer offer Down's syndrome screening on 22 July 2014 and, if she did, what exactly did she say? (b) did Mrs Mordel appear to decline the offer and, if she did, what exactly did she say?
  • Did the sonographer discharge her duty to Mrs Mordel in terms of obtaining the latter's informed consent?
  • If the answer to (1)(a) and (b) is ‘yes’ and (2) is ‘no’, was it in fact Mrs Mordel's wish not to undergo Down's syndrome screening on this occasion?
  • Did the midwife discharge her duty to Mrs Mordel on 11 August 2014 in not exploring why the combined test had not been carried out?
  • If the answer to (4) is ‘no’, would Mrs Mordel have informed the midwife pursuant to the exploration that ex hypothesi the latter should have conducted that she wanted Down's syndrome screening (ie the quad test)?
  • In the event that the answer to (3) is ‘no’ and/or to (5) is ‘yes’ (on the assumption that either or both of these questions arise), would Mrs Mordel have consented to invasive testing and a termination of the pregnancy?

Held

Issue (1): Mrs Mordel said that there was no discussion between herself and the sonographer at the appointment on Down's syndrome screening (Mordel, 2019). The sonographer argued that Mrs Mordel declined screening, evidenced by her action to select the drop-down menu which stated ‘Down's syndrome screening declined’(Mordel, 2019). It was submitted that the drop-down section would not have been selected if the patient wanted Down's syndrome screening (Mordel v, 2019). Jay LJ found Mrs Mordel's aspect of the evidence difficult to accept as it would be grossly negligent and would be a significant departure from the sonographer's standard practice (Mordel, 2019). He concluded that the process of selecting the drop-down option weighed in the sonographer's favour (Mordel, 2019). The basis of this finding was germane to reliability of recollection as opposed to Mrs Mordel's credibility (Mordel, 2019).

Issue (2): an expert witness for Mrs Mordel deemed the initial question, ‘Do you want the Down's screening’, as insufficient (Mordel, 2019). The expert used the example that some women enter the room under the presumption of having the ‘needle test’ (amniocentesis), rather than combined screening (Mordel, 2019).

The expert witness for the sonographer explained that it was not the role of the sonographer to re-counsel the patient or to provide further information (Mordel, 2019). Another witness for the sonographer explained that the patient does not provide their informed consent at the booking appointment, rather they are given an informed offer for screening (Mordel, 2019). An important consideration was that change of mind would not be rare on part of the patient and the expert witness frequently encountered this in practice (Mordel, 2019). Because of this, he said he would ask patients carefully about their choice regarding screening (Mordel, 2019).

This issue related to whether the sonographer's practice was ir responsible, unreasonable and unrespectable, if not illogical, in the light of the duty to take reasonable steps to secure consent (Mordel, 2019). Jay LJ argued that consent is a fundamental principle of the modern NHS and that it would be unrealistic to expect policy documents to prescribe how consent should be obtained (Mordel, 2019). He found that the sonographer had overstated the difficulty in exploring the patient's level of understanding without appearing to undermine her decision (Mordel, 2019). Jay LJ highlighted that it is not the patient's reasons for accepting or rejecting screening which needs dissecting by the healthcare professionals but rather a ‘gentle exploration’ of patient's state of mind (Mordel, 2019). He believed that patient autonomy is rarely undermined by gentle inquiry, arguing that this increases autonomy by enhancing patient understanding (Mordel, 2019).

What was in dispute was not what constitutes informed consent but the nature of the steps required to secure it. The undertaking of reasonable steps was desired as the NHS could not operate if the law required guarantees and complete ‘fail-safes’ (Mordel, 2019). Jay LJ stated that what is reasonable cannot depend on the attributes and characteristics of any particular patient, as an examination of Mrs Mordel's actual wishes is highly germane to causation but it has no relevance to the issue in question (Mordel, 2019).

The court concluded that it is the duty of the sonographer to satisfy themselves, by taking reasonable steps, that the patient is consenting, or in this case not consenting, to the procedure (Mordel, 2019). This involves (i) checking that there has been a discussion between patient and midwife, (ii) checking that the patient has been supplied with the NHS booklet, and (iii) ascertaining by brief questioning that the patient understands the essential elements and purposes of scanning for Down's syndrome (Mordel, 2019). Evaluating the facts against this approach, common sense and expert evidence dictated that informed consent had not been obtained (Mordel, 2019).

Issue (3): the defence argued that Mrs Mordel had bitterly regretted her change of mind to not have screening and ‘persuaded herself that events happened as she would have wished’ due to the outcome (Mordel, 2019). However, it was argued that Mrs Mordel reasonably believed, in the heat of the moment, that she was undertaking screening as the sonographer's actions were consistent with the NT measurement being undertaken (Mordel, 2019). Jay LJ found in favour of Mrs Mordel for this issue.

Issue (4): the expert witness for Mrs Mordel was asked about the National Institute for Health and Care Excellence (NICE) guidelines in the context of decision-making for Down's syndrome screening (Mordel, 2019). The expert agreed that it is the patient's right to choose following sections 7 and 8 of NICE, and that asking a limited number of questions should not impede on the patient's autonomy or free choice (Mordel, 2019). Jay LJ explained that it cannot be incumbent on the midwife to undertake lengthy inquiry or to delve into the patient's reasoning process but where the patient was booked to have the combined test and did not receive it, the midwife should not have left the matter there (Mordel, 2019). It was concluded that the failure of the midwife to establish patient understanding, by gentle questioning, constituted sub-standard care and therefore failed to discharge her duty (Mordel, 2019).

Issue (5): Jay LJ concluded that the answer to this question was, ‘yes’ (Mordel, 2019).

Issue (6): Jay LJ had the task to resolve whether, on the balance of probabilities had there been no breach(es) of duty, would have (i) consented to invasive testing (amniocentesis), and then (ii) sought a termination (Mordel, 2019). It was concluded that, on the balance, Mrs Mordel probably would have proceeded to have invasive testing had she been aware of the high-risk, and then sought a termination (Mordel, 2019).

Discussion

Mordel underlined the need for healthcare professionals to establish informed consent by taking reasonable steps to support patient understanding and autonomy. The decision proved to be a paradigm shift in the context of the sonographer's role to obtain informed consent from expectant parents. However, the judgment left key issues unresolved, leaving it for future courts to unpick. It also leaves questions for healthcare professionals and expectant parents in relation to who should be involved in supporting decision-making. The outstanding issues I have identified from the decision are discussed below.

Residue of Bolam on issues of information disclosure

Bolam was considered as the gold standard by the UK courts for a long time to resolve issues of information disclosure and consent (Bolam v Friern Hospital Management Committee, 1957). Application of this standard meant that the court would assess whether a medical practitioner had acted negligently in accordance to whether the practice was accepted as proper by a responsible body of medical professionals skilled in that particular area, ‘…a doctor is not negligent if he is acting in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art’ (Bolam, 1957).

In a post-Montgomery era (Montgomery v Lanarkshire Health Board, 2015), case law has long attributed to the inappropriateness of the Bolam test to resolve issues of information disclosure and consent as it was said to encourage a culture of paternalism, the antithesis to patient choice and autonomy.

The landmark decision of Montgomery recognised that current models of care are underpinned by the patients' right to self-determination and autonomy (Montgomery, 2015). This ruling also highlighted the importance of taking reasonable steps to support the particular patient's understanding of a proposed intervention when securing informed consent (Montgomery, 2015). The duty of healthcare professionals extends to disclosing information on the material risks, benefits and alternative healthcare options (Montgomery, 2015). Montgomery brought the law into line with the guidance published by the General Medical Council (2008) on informed consent.

Despite the obvious temptation of LJ to apply Bolam to the question of information disclosure in Mordel, he referred to the application of Montgomery to explore the issue of informed consent, to which he emphasised that, ‘…the need for it to be truly informed is a question of right rather than discretion; and that the patient must be provided with sufficient information to make an informed decision’ (Mordel, 2019). Tavares QC (2019) explained that this case to practitioners, ‘…gives another example of the application of Montgomery’.

English language competency

The press and initially the courts focused unduly on Mrs Mordel's standard of English, suggesting this was the reason behind the misunderstanding. It was said in the case that her English language was good but not excellent (Mordel, 2019). Indeed, this factor, choreographed by the defence, was used in an attempt to influence the court into believing that a relaxation to the duty of care owed to Mrs Mordel is justifiable. However, this observation was not germane to the standard owed to Mrs Mordel by the healthcare professionals, nor the outcome of the case (Mordel, 2019). Reviewers of this case must not get distracted by this factor as it had little if any influence on the subsequent decision, nor on the duty imposed by Montgomery on healthcare professionals for obtaining informed consent. From a legal and moral perspective, the burden should not rest on Mrs Mordel to show whether she understood the information by challenging her English competency. Although the patient's ability to comprehend the information is part of the process which may be impacted by language barriers, healthcare professionals must still owe the same duty of care to all patients (General Medical Council, 2008; Nursing and Midwifery Council, 2018; Ikhilor et al, 2019).

The demand of satisfying the duty of care in the context of this case may require the taking of extra steps by healthcare professionals to support patient understanding (Cramer, 2017; Nursing and Midwifery Council, 2018; Ikhilor et al, 2019). This may be to provide accurately translated materials or seek the assistance of a translator (Haith-Cooper, 2014; Nursing and Midwifery Council, 2018). However, it is not desirable for family or friends to act as translators. This is because (i) a risk exists that the information may be misinterpreted, (ii) material information is at risk of being lost in translation, and (iii) the perception of the family member may differ to that of the healthcare professionals in terms of what information is relevant to the patient (Haith-Cooper, 2014; Nursing and Midwifery Council, 2018; Ikhilor et al, 2019).

Pre-emptive action must be taken to ensure that this risk is minimised in the future, requiring healthcare professionals to take reasonable steps to accommodate any barriers to communication (Sanders et al, 2016; Nursing and Midwifery Council, 2018). This reflects the primacy of the service user or patient and the need to ensure practice is beneficent and reflects professional codes of ethics (Moyo et al, 2016). However, it does not resolve some of the historical issues in relation to power, control and the culture of medical hegemony which continues to assume authority over healthcare decision-making (Diamond-Brown, 2018).

Discussion of mental capacity fell outside the ambit of this case, however, the question remained whether Mrs Mordel would have understood the information materials on screening even if she had received and read this information in her first language, or alternatively, had been provided with a translator to support her understanding.

Obtaining consent: reasonable steps and the ‘gentle exploration’ requirement

The newly imposed ‘gentle exploration’ requirement in the context of taking reasonable steps necessary to obtain informed consent remains an unresolved issue in this judgement (Mordel, 2019). As the law currently stands, effective execution of this requirement is entirely dependent on the interpretation of the healthcare profession due to the courts failure to establish the requisite threshold.

It is understandable that producing a set of guidelines which would satisfy this definition of a ‘gentle exploration’ is not desirable, as the process of obtaining informed consent should not be proscriptive (Mordel, 2019). However, in the absence of tool or mechanism forged by the court, this term becomes entirely discretionary, enabling healthcare professionals to adopt a carte blanche approach to formulate or tailor their approach subject to the particular patient. Although this could allow for greater flexibility and service-user autonomy, a foreseeable side-effect to this is the potential for a wide range of interpretations and outcomes (Moyo et al, 2016). Indeed, a complete misinterpretation, or improper execution of this requirement is a foreseeable risk in these circumstances. This requirement, as it stands, is unhelpful to healthcare professionals in fulfilling their duty to obtain the patients' consent.

In an effort to address this issue, Jay LJ explained that it would be inappropriate to pry into the patient's reasons as this could undermine patient choice (Mordel, 2019). He explained that this risk of undermining patient choice will only arise in the event of ‘maladroit or insensitive interrogation, and NHS professionals are well habituated to avoid that’ (Mordel, 2019). However, this flippant conclusion is rather naïve. This raises the question whether NHS professionals truly feel ‘well habituated’ to avoid this risk. Jay LJ's assumption is contrary to the experience of the sonographer who highlighted the difficulty in exploring the patient's level of understanding without appearing to undermine her decision (Mordel, 2019). This risk increases when exploring the patient's state of mind after declining screening.

Jay LJ's point that Mrs Mordel's actual wishes had no relevance to the second issue was fundamentally flawed and could have serious implications to practicing healthcare professionals (Mordel, 2019). Given that the underlying principle of consent is that of self-determination and patient autonomy, Montgomery (2015) illustrated that the particular patient's wishes and needs are central to informed decision-making and consent. Therefore, Montgomery, interpreted correctly, would mandate that without reasonable exploration of the particular patients' needs or wishes, the sonographer is unable to discharge her duty in relation to obtaining informed consent (General Medical Council, 2008; Nursing and Midwifery Council, 2018). To proceed on such a basis would deprive the particular patient of their right to make a truly informed decision.

Mordel also raises the question whether sonographers, who are technicians by trade, feel equipped to deal with counselling patients on matters of consent. After an exploration of the patient's state of mind, the reasonable steps sonographers must take are not entirely clear if the patient has not understood the information. While Jay LJ explained that these patients should return to their midwife for further counselling on decision-making ‘preferably on the same day’ (Mordel, 2019), under the current time constraints experienced by the NHS, this is at best idealistic, and at worse, entirely impractical and unlikely (Cioffi, 2012).

Midwives receive robust training on the interaction between patient and professional during pre- and post-screening counselling, and also the requisite duty imposed by law to inform patients about screening (Nursing and Midwifery Council, 2018; Fetal Anomaly Screening Programme, 2019; Antenatal Screening Wales, 2019). This begs the question whether the training provided to sonographers should be brought into line with the training midwives receive on counselling patients to ensure that sonographers are well-equipped to navigate their new role imposed by the decision. It might be that instead, the role of midwives should be extended to include involvement at this stage of the care journey. Employing midwives specifically to address issues of consent on the day of the 12-week scan could enable midwives to take a specialist role in supporting parental decision-making, providing consistency in provision of counselling and assurance of individuality for the purposes of securing consent.

This risk of negligence is pertinent to the introduction of the amended trisomy screening pathway. Counselling will need to be tailored depending on which conditions parents decide to screen for (Nuffield Council, 2017; Nursing and Midwifery Council, 2018; FASP, 2019). Training must reflect that the nature of the discussion and the counselling healthcare professionals deliver on Edwards' and Patau's syndrome should, due to their prognosis, be vastly different to that on Down's syndrome (Nuffield Council, 2017; Fetal Anomaly Screening Programme, 2019; Antenatal Screening Wales, 2019). This issue must be addressed as, without clear guidance from the courts, the risk of being insensitive or maladroit will significantly increase under the amended trisomy pathway.

Conclusion

There is an emergent need here to review and perhaps improve the ways in which midwives are both prepared for and supported in providing information, guidance, counselling and support for parents in relation to decision-making around antenatal screening. The complexity and sensitivity of the legal requirements, combined with ethical and professional codes that place the onus on the pregnant person, may require midwives to take more time with their clients to support understanding and decision-making, enhanced by continued professional development and education in this regard (Antenatal Screening Wales, 2019; Fetal Anomaly Screening Programme, 2019).

Obtaining informed consent is a process and not just a one-off event. The booking appointment is considered to be an informed offer of trisomy screening, requiring sonographers to obtain consent on the day of the 12-week scan (Mordel, 2019). Mordel underlined that healthcare professionals should not cross-examine the patient on the reasons for undertaking or declining screening but rather establish that the patient understands the purpose of screening and what it involves (Mordel, 2019).

The ruling in Mordel conveyed that the healthcare professionals duty of care extends to disclosing clear and accurate information during counselling on the methods of screening and the conditions being screened for (Mordel, 2019). Under the amended trisomy screening pathway, this now requires healthcare professionals to accurately discuss NIPT and the option of screening for Edwards' and Patau's syndrome (Antenatal Screening Wales, 2019; Fetal Anomaly Screening Programme, 2019).

It is paramount that healthcare professionals should take consideration of the reformed duty placed on sonographers and midwives in the process of obtaining informed consent from expectant parents on trisomy screening. Healthcare professionals must critically evaluate the ‘gentle exploration’ requirement, in the context of examining the patient's state of mind, for the purposes of establishing consent (Mordel, 2019). Identifying that what is reasonable in relation to the second issue – did the sonographer discharge her duty to Mrs Mordel in terms of obtaining the latter's informed consent – should depend on the attributes and characteristics of any particular patient following the fundamental principles from Montgomery (2015) on consent (General Medical Council, 2008).

Consideration is required of whether training for sonographers on counselling patients for trisomy screening should be brought in line to that provided to midwives. An alternative may be to extend the role of midwives to include involvement at the day of the 12-week scan to specifically address the provision of securing expectant parents consent for screening. Training must be amended subject to the formation of the trisomy screening pathway and should reflect its new implications (Antenatal Screening Wales, 2019; Fetal Anomaly Screening Programme, 2019).

Key points

  • Ensuring that the expectant parent has understood the information on trisomy screening is a key consideration in the context of the healthcare professionals duty of care when securing informed consent
  • Obtaining consent from the expectant parent for trisomy screening is a process and not just a one-off event at the booking appointment. The booking appointment is now considered to be an informed offer of trisomy screening, requiring the sonographer to secure informed consent on the day of the 12-week scan
  • The reformed duty imposed by Mordel on midwives and sonographers requires that reasonable steps are taken, by conducting a ‘gentle exploration’ into the expectant parent's state of mind, to ensure patient understanding and that valid consent has been obtained
  • Mordel raises the question whether the training provided to sonographers should be brought into line to that provided to midwives on counselling expectant parents for trisomy screening

CPD reflective questions

  • How can I successfully implement these amendments to my duty of care for the purposes of securing informed consent in clinical practice?
  • Is there anymore I could do to ensure that expectant parents have got sufficient information to support informed decision-making?
  • How can I ensure that I have taken reasonable steps to identify whether the expectant parent needs more support to understand the information they have been given?
  • How can I overcome any barriers to communication in the process of securing informed consent?