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Informed consent is critical as elective surgery resumes — healthcare company

With medical malpractice litigation in South Africa having more than doubled over the past two years, the added complication of COVID-19 raises a large red flag over minimum requirements for informed consent to surgical and medical treatment, writes Chris Bateman.

Patients need to insist on adequate information before undergoing any treatment or procedure, while surgeons and doctors need to ensure they get it and understand all the risks and implications involved – in the best interests of both parties. Vitally, this mutual understanding should be reached before patients sign any informed consent documents, because there are far-reaching legal implications.

A landmark court ruling in the UK in 1999, now integrated into South African law, has moved the test for informed consent from the “reasonable doctor” (acting on a responsible body of medical opinion), to the “reasonable patient” . This dramatic shift away from the doctor knows best, traditional approach, shifts the test of materiality towards the patient. The test is now whether, in the circumstances of a particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk.

This means it’s up to the doctor to be reasonably aware that the particular patient would be likely to attach significance to the risks outlined – and to record having obtained such informed consent. Failure to do so risks both debilitating outcomes and litigation should an adverse event, especially one with long-term or life-long effects, occur.

The change to informed consent is in line with the modern, now widely accepted “patient-centric” approach to medicine. It emphasises the importance of enriching the doctor-patient partnership, where both views are considered, and all necessary information is provided to enable an optimal outcome.

For some of the higher risk specialities like obstetrics and gynaecology, orthopaedics and neurology, the explosion of litigation in South Africa now threatens core healthcare delivery in a country with a quadruple burden of disease and a dire paucity of healthcare workers.

According to South African Treasury data early last year, a “near exponential” increase in medical negligence claims against the state left provincial health departments with R80.4bn in contingent liabilities, equivalent to more than 40% of total budgets for 2020. In February 2019, teams of outside experts began helping manage, negotiate and prepare for the defence of 14,000 outstanding cases of litigation against the State.

The slow build up to this crisis over the past decade means that consultants in obstetrics are now paying medical insurance subscriptions of over R1m rand per annum, with more and more at-risk senior specialists considering early retirement. Their younger colleagues are being driven to consider moving to greener, less-pressured and more ‘patient-friendly’ foreign climes, while qualified medical students are avoiding studying for high-risk specialities.

This has dire implications for the future of patient care in South Africa, prompting a headline in the SA Medical Journal of 2014, of “who, if anyone, will be performing deliveries in private practice by the end of the decade?”

Perhaps most significantly, a full 30% of medical malpractice claims handled by one of the world’s largest insurers and the leading one in South Africa, the UK-based Medical Protection Society (MPS), are related to either weak or absent informed consent.

The accelerating rate of South Africa is best illustrated with data from 2013 when claims exceeding R1m had increased by nearly 550% compared with those of the previous 10 years, while claims valued at over R5m had increased by 900% in the past 5 years. Media reports of high damages awarded for malpractice in public health institutions are now commonplace.

According to Eido Healthcare, a company specialising in informed consent and gold-standard leaflet-based advice, MPS claims experience in South Africa over the past five years shows that the alarming deterioration has gathered pace – so much so that over the past two years alone, the value of reported claims overall has more than doubled: an increase of 132%.

Add to this the risks and challenges posed by COVID-19-affected or infected patients needing surgery, whether urgent and possible or not (hospital C-19 patient burden-dependant). Co-morbidities and old age, (alone or together), are responsible for most COVID deaths.

At present in South Africa (with a second wave of the pandemic hopefully remaining at bay), long-postponed elective procedures have resumed with vigour as surgeons work through a backlog of afflictions, many of which worsened during the COVID lockdown.

Hospital C-19 patient infection risk is now thankfully hugely reduced through the application of a new-grown body of prevention and containment knowledge, not to mention vastly reduced COVID-19 patient numbers. However, initially this meant only urgent, (read emergency), surgical cases were admitted as the pandemic waxed to a peak before waning sufficiently. Surgical procedures were only conducted if the benefits outweighed the risks – something that surgeons had to carefully weigh up with patients to ensure their consent was based on a full understanding of both. All routine elective surgery was cancelled.

Eido Healthcare says it’s now mandatory in South Africa for every patient to be informed of their health status, the range of diagnostic procedures, and their treatment options. The company says every patient must be informed of the benefits, risks, costs, and consequences generally associated with each option. It stresses that the law prohibits any health service from being provided to a patient without his or her informed consent, meaning, in blunt terms that the patient should be the one who decides what happens to his or her body.

Patients must also be informed of their right to refuse health services – and the implications, risks and obligations of such refusal. Eido strongly recommends that the patient requests written documentation explaining all this, in a language they understand.

Says Matthew Blewett, MD of Eido Healthcare, South Africa, “it’s vitally important that clinicians understand the huge risk involved if they fail to inform their patients properly. On the other hand, the public has a right to know and better understand the risks and the procedure, and how it could affect their lifestyle going forward.”

 

The fundamental shift in informed consent is based on a successful British High Court claim , writes Bateman, brought in 1999 by Nadine Montgomery after she gave birth by vaginal delivery to her son, Sam. The delivery was complicated by shoulder dystocia (after vaginal delivery of the head, the baby's anterior shoulder gets caught above the mother's pubic bone). Medical staff performed the appropriate manoeuvres to release Sam, but during the 12-minute delay, he was deprived of oxygen and subsequently diagnosed with cerebral palsy.

Mrs Montgomery is diabetic and small in stature and the risk of shoulder dystocia was agreed to be 9-10%. Despite expressing concern to her consultant about whether she would be able to deliver her baby vaginally, the doctor failed to warn Mrs Montgomery of the risk of serious injury from shoulder dystocia – or the possibility of an elective caesarean section.

In her claim against the Lanarkshire Health Board, she said that she should have been advised of the 9-10% risk of shoulder dystocia associated with vaginal delivery even though that the risk of a grave outcome was small (less than 0.1% risk of cerebral palsy). Mrs Montgomery further contended that she should have been offered a caesarean section which would have prevented the child’s injury.

The High Court held that the central question should have been about Mrs Montgomery’s likely reaction if told of the risk of shoulder dystocia. The unequivocal position was that she would have chosen birth by caesarean section. The court ruled that Mrs Montgomery should have been informed of the risk of shoulder dystocia and given the option of a caesarean section. The judges awarded her £5.25m in damages (the equivalent of about R52,5m at the time).

 

[link url="https://en.wikipedia.org/wiki/Montgomery_v_Lanarkshire_Health_Board#:~:text=Montgomery%20v%20Lanarkshire%20Health%20Board%20%5B2015%5D%20UKSC%2011%20is%20a,criteria%20of%20an%20informed%20consent."]Montgomery v Lanarkshire Health Board Judgment on Wikipedia[/link]

 

See also from MedicalBrief archives:

 

[link url="https://www.medicalbrief.co.za/archives/provincial-health-services-risk-r80-4bn-medical-negligence-claims/"]Provincial health services at risk over R80.4bn in medical negligence claims[/link]

[link url="https://www.medicalbrief.co.za/archives/sca-dismisses-patients-appeal-informed-consent/"]SCA dismisses patient's appeal over informed consent [/link]

 

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