Patients Are Still Misinformed About Electroconvusive Therapy

Informed consent is a core ethical principle of all mental health professionals. The World Psychiatric Association’s Code of Ethics (2020) states: 'In pursuing informed consent, psychiatrists should offer patients accurate information about their diagnoses, proposed treatments, risks, potential benefits and alternatives'.

Two years ago I reported, here, on our survey of patient information leaflets about electroconvulsive therapy (ECT) in England. On the basis of leaflets from 36 of 51 clinics (71%), we concluded that informed consent is not being complied with, because: ‘Patients are being misled about the risks they are taking and the limited nature of ECT’s benefits’.

This month sees the publication of two follow up papers. The first¹ is a replication of our first audit, in ECT clinics in Northern Ireland, Scotland and Wales. Of the 26 ECT facilities, 23 (88%) provided their leaflet. These were scored, by two independent raters, on the same 40-item accuracy measure used in the England audit.

The idea for the study came from our co-author Lisa Morrison who has had 96 ECTs herself.

The results were almost as disappointing as the England audit. The number of accurate statements (out of a possible 29) ranged from seven to 20, with an average of 16.9. The most frequently omitted crucial pieces of information were: cardiovascular risks (included by only five leaflets), that it is not known how ECT works (3), risk of mortality (2), risks from multiple general anaesthetic procedures (2), how to access a legal advocate (2), and that that there is no evidence of long-term benefits (1).

The leaflets also made between six and nine inaccurate statements (out of 11) with an average of 7.0. Nineteen minimised memory loss, blamed the memory loss on depression, claimed that ECT is the ‘most effective treatment’, and asserted it has very high response rates without mentioning similar placebo response rates. All 23 leaflets told patients that ECT saves lives, although almost all studies either find no difference between ECT and non-ECT groups, or that the ECT group has higher suicide rates.

We recommended:

• ‘Psychologists and other mental health professionals have a shared responsibility to implement the ethical principle of informed consent.
• All mental health professionals need to inform themselves of the research evidence for the efficacy and safety of all treatments offered to their patients.
• Managers of mental health services, and government agencies, need to actively oversee ECT clinics, including the information given to patients.’

The second paper² reports on our efforts to use the 2021 England audit to improve the accuracy of leaflets. My colleague, Dr Chis Harrop, wrote to the managers of all 51 England NHS Trusts, summarising our audit’s findings and detailing the accuracy of their own Trust’s leaflet. We asked what changes would be undertaken.

The responses could be described, at best, as mixed. While only nine of the 51 responded, three made a clear commitment to improve their leaflet, and to include patients in the process:

‘We will be acting on your recommendations, particularly as a co-designed leaflet seems like a really good idea.’

‘We are acting to strengthen our informed consent processes immediately and also through co-creation with patients and carers of an updated information leaflet that accommodates your findings, for use within the trust’

‘In direct response to your correspondence, we have committed to completely re-write our patient information leaflet, ensuring that it is co-produced with service users having lived experience of receiving ECT at the trust.’

Meanwhile, the Royal College of Psychiatrists also committed to updating its own leaflet (used by some of the clinics) as a result of our 2021 audit. Their leaflet at the time of our 2021 audit had 15 accurate (out of 29) and seven inaccurate statements (Harrop et al, 2021). Their amended leaflet added five new accurate statements including:

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• Information about rights under the Mental Health Act
• Memory loss is more common in women and older people
• Mention of psychosocial causes of depression rather than just portraying depression as an ‘illness’

It still, however, had seven misleading statements, including:

• Minimizing size/strength of electric current (‘use of small, very small or other diminutive terms’)
• False claims of ‘most effective’ treatment
• False claim that ECT is life-saving
• Claims that ECT corrects biological deficits
• Minimisation of memory loss (re severity or prevalence)

The minimisation of risks is not uncommon in ECT practice and research. Two recent studies of ECT on adolescents (mostly girls) in China described rates of 68% and 69% memory impairment as ‘acceptable’ (Chen et al 2022), and indicative of a ‘high’ degree of safety (Li et al. 2023), respectively. We have objected to this approach to the developing brains of teenagers.

In other ECT related news, the first of several ECT legal cases in the UK, USA and Canada made it to court last month, in Florida. I served as an expert witness regarding safety and efficacy. The jury found that Somatics, a manufacturer of ECT machines, failed to adequately warn about the risks associated with its device. The jury also concluded, however, that this failure was not a ‘proximate cause’ of the plaintiff’s injuries. (The plaintiff's lawyers have just filed for a new trial on procedural grounds). In a previous case, Somatics settled out of court but subsequently added ‘permanent memory loss and brain damage’ to their list of adverse effects.

Meanwhile, the campaign for an independent inquiry into how ECT is administered, monitored and regulated in the UK continues.

Potential ECT patients, and their, families have a right to accurate, evidence-based information. Mental health professionals are obliged to implement the ethical principle of informed consent. It seems neither is happening yet.