The NSW Department of Health is clear in its documentation for consent: As a general rule, no operation, procedure or treatment may be undertaken without the consent of the patient, if the patient is a competent adult. Adequately informing patients and obtaining consent in regard to an operation, procedure or treatment is both a specific legal requirement and an accepted part of good medical practice… Failure to (obtain consent) could result in legal action for assault and battery against a practitioner who performs the procedure.
The obligation to obtain consent is distinct from the obligation to disclose information to a patient and warn a patient of material risks. As a rule, all patients have a choice as to whether or not to undergo a proposed procedure, operation or treatment. While a patient might consent to a procedure once he or she has been informed in broad terms of the nature of the procedure, this consent will not amount to the exercise of choice unless it is made based on relevant information and advice. Patients must also be provided with sufficient information about the condition, investigation options, treatment options, benefits, possible adverse effects or complications, and the likely result if treatment is not undertaken, in order to be able to make their own decision about undergoing an operation, procedure or treatment.
A medical practitioner has a legal duty to warn a patient of a material risk inherent in the proposed treatment. Failure to do this may be a breach of the practitioner’s duty of care to the patient and could give rise to legal action for negligence. Patients have a legal right to refuse treatment. Consent of the patient is therefore required to be obtained in nearly all cases.1
Obstetric care is unique in terms of medical and social expectations. The course of pregnancy, labour and vaginal delivery is considered ‘natural’, and interference with this ‘natural progression’ is viewed as an intervention.
We are not aware of what is happening elsewhere in Australia, but in our home state, NSW Health has produced a rather remarkable document titled Towards Normal Birth in NSW, (see boxed extract), which espouses the following themes:
- the promotion of birth as a natural event for most women;
- the need to minimise fear, particularly women’s fear, and improve support throughout labour and birth;
- the importance of consistent and balanced information for women and healthcare providers regarding vaginal birth after caesarean section (VBAC) and the potential risks associated with elective caesarean; and
- the need to develop programs of care, both midwifery and medical, that focus on providing continuity of care.
The document does not address the potential risks of labour and normal birth, and while a consent process is mandatory for caesarean section, there is no suggestion that this is required before a woman embarks upon labour. The document refers to the ‘potential risk’ of elective caesarean section, but does not appear to specifically mention the risks associated with VBAC.
The NSW Department of Health is explicit in its requirements around ‘normal delivery’:
Written consent is not required for a normal delivery. Should an operation such as a caesarean section or a blood transfusion be required, the consent process as detailed should be completed, insofar as it is practicable to do so in the circumstances. If implied or oral consent is given to a particular procedure, (such as the use of forceps) this should be noted in the patient’s medical record. Discussions about alternatives and material risks should be documented in the record. It may be appropriate for practitioners to discuss these additional procedures during the term of the pregnancy.2
To this end, caesarean section requires the written consent of the patient, whereas for the initiation of labour, management of labour and vaginal interventions for birth (for example, instrumental delivery and episiotomy) ‘implied consent’ is considered adequate. However, few would dispute that the course of labour involves inherent risk that may be material to the patient. This article concerns itself with the obstetrician’s duty of care to inform the patient of the risks involved. In particular, birth presents an alternative, that is, caesarean section.
Obstetric care is further complicated by the presence of two patients. By legal definition, the fetus does not have independent rights, although once born, as a separate entity, the child can claim that actions by others may have influenced a negative outcome. The interests of the fetus (or the subsequent neonate) may compete directly with the needs or wishes of the mother. The law is unequivocal in its recognition of the physician’s primary responsibility to the mother.
While there are specific risks associated with elective caesarean section, particularly in terms of future pregnancies, it appears inadequate to avoid discussion of the risks associated with labour and vaginal delivery. Even if one limited the discussion to the risk and consequences of perineal trauma, surely it is incumbent on the obstetrician to attempt to convey the material risk of urinary incontinence, anal sphincter injury, uterovaginal prolapse and sexual dysfunction to a patient planning a labour and vaginal delivery. Furthermore, the incidence of post-traumatic stress disorder, perinatal anxiety and depression, difficulty breastfeeding and impaired maternal-child bonding has been linked to a negative birth experience.
Fascinatingly, NSW Health insists on consent for major medical treatments. Examples relevant to obstetrics and gynaecology include:3
- any treatment that involves the administration of a long-acting injectable hormonal substance for the purpose of contraception or menstrual regulation
- administration of a long-acting injectable hormonal substance for the purpose of contraception or menstrual regulation• any treatment that involves the administration of a general anesthetic or other sedation
- any treatment used for the purpose of eliminating menstruation
- any treatment that involves a substantial risk to the patient (thatis, risk that amounts to more than a mere possibility) of: (a) death; or (b) brain damage; or (c) paralysis; or(d) permanent loss of function of any organ or limb; or (e) permanent and disfiguring scarring; or (f) exacerbation of the conditions being treated; or (g) an unusually prolonged period of recovery; or (h) a detrimental change of personality; or (i) a high level of pain and stress
It is of interest to note that in NSW, a consent form is required before administration of anti-D to a pregnant woman can be undertaken, in circumstances where long-term data demonstrates great efficacy and safety with this product, but ‘written consent is not required for a normal delivery’.4
Obstetric care often (not always) offers multiple opportunities for informative discussion. The National Health & Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research, 2007 advises, ‘Respect for human beings involves giving due scope to people’s capacity to make their own decisions’.5 While outcomes are not always predictable, many obstetric outcomes are foreseeable. Indeed, the outcome for elective caesarean section, for example, is fairly standardised.
The debate about how women should be cared for in pregnancy, labour and birth will continue. However, recognition of the woman’s autonomy, right to be informed and right to informed choice should be paramount and amounts simply to fair, reasonable and ethical care. In the normal course of obstetric care, we suggest that women should formally consent to labour and vaginal delivery.
Consent is required for a surgical procedure such as caesarean section, because of the inherent risks, both immediate and future. Labour and vaginal delivery, too, carries inherent physical and psychological risk. In standard clinical practice understanding of those risks is assumed. However, we would argue that this is unreasonable. A woman with no prior experience of birth cannot reasonably be expected to have an understanding of the potential pain, fatigue, risk of emergency caesarean section, risk of perineal trauma or risk of postpartum haemorrhage.
The NHMRC in 1993 produced a set of guidelines for medical practitioners on providing information to patients which is largely in accord with the findings in Rogers V. Whitaker.
The NHMRC recommends that practitioners discuss:
(i) the possible or likely nature of the illness;
(ii) the proposed approach to investigation and treatment including:
– what the proposed approach entails,
– the expected benefits;
– common side effects and material risks;
– whether the procedure is conventional or experimental; and
– who will undertake the intervention.
(iii) other options for diagnosis and treatment;
(iv) the degree of uncertainty of the diagnosis and any therapeutic outcome;
(v) the likely outcome of not having the diagnostic procedure or treatment, or of not
having any procedure or treatment at all;
(vi) any significant long term physical, emotional, mental, social, sexual, or other
outcome which may be associated with the proposed intervention; and
(vii) the time and cost involved including any out of pocket expenses.
The NHMRC guidelines note that a practitioner’s judgment about how to convey risks will be influenced by a number of factors. These include: the seriousness of the patient’s condition, the nature of the intervention (complex interventions require more information); the likelihood of harm and the degree of possible harm; the questions asked by the patient; the patient’s temperament, attitude and level of understanding (including literacy and intelligence level); and accepted medical practice. Information should be provided in a form and manner which helps patients to understand the problem and the treatment options available, and which is appropriate to the patient’s circumstances.
References
- Consent to Medical Treatment – Patient Information Document Number PD2005_406 Publication date 27-Jan-2005. NSW Health. www0.health.nsw.gov. au/policies/PD/2005/pdf/PD2005_406.pdf.
- Consent to Medical Treatment – Patient Information Document Number PD2005_406 Publication date 27-Jan-2005. NSW Health. www0.health.nsw.gov. au/policies/PD/2005/pdf/PD2005_406.pdf.
- Consent to Medical Treatment – Patient Information Document Number PD2005_406 Publication date 27-Jan-2005. NSW Health. www0.health.nsw.gov. au/policies/PD/2005/pdf/PD2005_406.pdf.
- Consent to Medical Treatment – Patient Information Document Number PD2005_406 Publication date 27-Jan-2005. NSW Health. www0.health.nsw.gov. au/policies/PD/2005/pdf/PD2005_406.pdf.
- National Statement on Ethical Conduct in Human Research (2007) (Updated May 2015) NHMRC. www.nhmrc.gov.au/book/national-statement-ethical-conduct-human-research.
- Consent to Medical Treatment – Patient Information Document Number PD2005_406 Publication date 27-Jan-2005. NSW Health. www0.health.nsw.gov.au/policies/PD/2005/pdf/PD2005_406.pdf.
Leave a Reply