Montgomery and informed consent: where are we now?

Dear Editor

How very sad that on entering the sixth year since the Judgement in Montgomery vs Lanarkshire Health Board was published, reporting on a July 2020 Review chaired by Baroness Julia Cumberlege, “Analysing the Cumberlege Review: who should join the dots for patient safety?” evidences the fact that huge failings are still taking place with patient consent not being properly engaged for many medical interventions, patients not receiving the correct level of information and being excluded from the decision making.(1)

How can it be, after all this time, we as nation still have not effectively learnt from past failures re informed consent and imposed higher standards and tighter controls since Montgomery? The legal and ethical requirements re the correct standards of pre intervention care, dialogue and discussion to ensure informed consent, are clearly laid out in Montgomery.

Why are there still an inexcusable number of occasions where informed consent has not been properly obtained, often with disastrous consequences for the patient and huge fines for the health care professionals and their employers for failing to do so? Research undertaken at Queen Mary University of London found that while the rate of increase of other claims has remained steady, cases relating to consent have risen four-fold since March 2015. (2)

Is it not time for the many bodies who support, insure and regulate health care professionals to take determined action to not only identify the root cause of this persistent failing but to effectively deal with it once and for all so as to protect patients and their rights hereafter?

How many more years of reports, reviews, findings and recommendations identifying failures associated with informed consent and the remedies required to tackle the problem will it take to bring an effective change in procedures and a resultant downward trend in the statistics?.

The Cumberlege Review focussed specifically on three interventions all of which have been in the news; hormone pregnancy tests, Sodium Valproate and pelvic mesh implants.

With regard to pelvic mesh implants, the authors of the Review stated that that they were “appalled by the numbers of women who have come forward to say they never knew they had had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh”

Patients who took Sodium Valproate for their epilepsy during pregnancy did so without knowing that they could harm their unborn babies.

Hormone pregnancy tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages were the third intervention considered in the review.

Reporting on the Review included Baroness Cumberlege’s assessment of the impact on patients.

“Commenting on the report’s publication, its Chair Baroness Julia Cumberlege emphasised the impact on those involved, reflecting on harrowing stories of “relationships destroyed, careers broken, and as a result financial ruin, with no income, many lost their homes, and faced their children being taken into care” (3)

Perhaps one of the most shocking revelations lies in doctors still failing to respect patient autonomy in excluding them from decision making processes.

There was evidence of……

“Patients not being informed of risks involved, with doctors giving “advice based on their own assumptions, without involving patients in the decision-making process”(4)

Paragraph 87 of the Judgement from Montgomery determined the right of the patient to decide which treatment to undergo with the doctors role confined to ensuring that the patient was made aware of the scope of treatments available and the risks involved.

“An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.”

The MDDUS following Montgomery advised their membership that……..

"The judgment also states that it cannot be left to the doctor to determine what is reasonable to disclose; the move is to what a patient would attach importance to”(5)

The Review, raises further concerns in highlighting the fact that since Montgomery there had been “a significant increase in patient safety leaflets sharing information on risks of specific treatments but that the sheer variety of these and differing consent forms can be “bewildering and a major source of confusion”, a practice which was not supported by the findings in Montgomery in 2015 and definitely incapable of satisfying the legal requirements today.

Paragraph 90 of the Judgement states that “bombarding” patients with technical information with they cannot be reasonably expected to grasp does not absolve the practitioner of his role in providing patient specific information so tailored so as to be comprehensible to the individual patient.

“This role will only be performed effectively if the information provided is comprehensible. The doctor’s duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp….”
It would be a matter of grave concern, particularly when considered in light of the findings from the Review, if the profession had sought to comply with Montgomery, not by improving personal doctor - patient access, and information sharing etc but by churning out an increased number of patient safety leaflets as a substitute.

As for the question “who should join the dots for patient safety?” The Cumberlege Review of 2020 clearly provides the answer just as Montgomery did back in 2015………….

“ patients or their families should not be left to “join up the dots of patient safety” for patient safety”

The importance is not in asking the question over and over with similar debate and outcome but in asking…………who will heed the answer?

(1) https://www.patientsafetylearning.org/blog/analysing-the-cumberlege-revi...

(2) https://www.expressandstar.com/news/uk-news/2020/03/19/increase-in-negli...

(3) https://www.pslhub.org/learn/patient-engagement/consent-and-privacy/cons...

(4) https://www.patientsafetylearning.org/blog/analysing-the-cumberlege-revi...

(5) https://www.mddus.com/resources/resource-library/risk-articles/2015/marc...

As Hugo Wellesley (response 26 May) has commented, Montgomery is in line with other recent court rulings, in placing the emphasis on the situation as viewed from the perspective of the specific patient:

'a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.;

As Wellesley points out, the 'the particular patient would be likely to attach significance to it' wording is interesting 'logically' - 'this can seem like an impossibly high bar for doctors who cannot know exactly which details the particular patient in front of them may or may not consider significant'.

This 'doctors cannot know' is even more relevant when instead of Informed Consent the MCA's best-interests process is thought about, because recent rulings are making it increasingly clear that this same 'patient individuality' principle should guide best-interests decisions-making: logically therefore the people 'close to the patient' [the patient's close family and close friends], who do understand the patient's individuality far better than the patient's clinicians understand that individuality, should in fact be able to make better-considered best-interests decisions than the clinicians who are involved.

Professionals are resistant to that implication, which is one of many 'inconvenient conclusions' which follow if one reads the Mental Capacity Act in the context of its ethos of patient autonomy and 'patient individuality'. As I have pointed out previously, this change from an emphasis on clinical situations, to 'the autonomous decision of a mentally-capable patient [and for best-interests we have a similar if more complex situation, but still requiring an understanding of 'patient individuality'] within a clinical and wider-life situation' is something very challenging for working clinicians. In particular, one 'inconvenient conclusion' is that the MCA is a very hard read, if you are trying to fit it into a context of 'safeguarding'.

There is one fundamental difference between the application of 'individuality' within Informed Consent, or within best-interests decision-making. If the consultation had no time restriction and the patient is capacitous, then in theory an unlimited number of 'if you decide that, then '...' will be the result - do you understand that?' explanations/questions from the doctor, satisfy informed consent by eventually 'covering everything the patient needs to be aware of, in order to make an informed decision'. But this is not true, during best-interests decision-making: because during informed consent the patient only needs to express yes/no answers (consent or not) and the patient does not need to explain 'why I'm deciding as I am'. Whereas best-interests does require 'an understanding of the patient's mind' (that phrase is inexact - I can think of no precise and short phrase!) because the decision-maker has to incorporate that understanding into his own decision-making: during best-interests you cannot simply 'keep throwing in more clinical information, and finding out if the new information alters the patient's decision by simply asking the patient and seeing if his/her decision changes'

Interesting judgment and discussion about the ethics of not informing pregnant patients about facts that are relevant to them. Here in the Netherlands, I am hoping women (or their descendants) will start a few court cases about this, in particular because they were not informed antenatally about the option of a tubal ligation (TL) in case their deliveries became a caesarean section (CS), as FIGO advises to discuss long before term (1), and a study in the Netherlands shows most women with ≥1 children would desire (2). This can have serious consequences because without the TL there is of course much more risk of an unintended/ unwanted pregnancy (such women are regularly seen in abortion clinics, and are often particularly upset (2)). Risks related to pregnancy are larger for these if-given-the-option-would-have-chosen-a-TL-women compared to the risks in average pregnancies because of the uterine scar, because of possible recurrent complications related to the CS indication (e.g. diabetes, hypertension, >BMI) and because these women are on average older(3). On top of that, there are the costs and side effects (e.g. thrombosis on the pill especially in smokers when they get older) and anxieties related to contraception for the next 10-15 years. With leftover sutures from the uterine closure, the TL is gratis, unlike with clips or with hysteroscopic sterilisations later on: and at least as reliable (3). Moreover, a very likely benefit of TL, i.e. a significant reduction in subsequent ovarian carcinoma risk, is withheld ― bilateral total salpingectomy is probably most effective for this effect, and easily performed during a CS. These malignancies apparently often originate in the tubes and there is no good method (like with breast and cervix carcinoma) to detect with screening these neoplasms when still relatively harmless (3). Conversely, serious TL regret is of course a risk, but many gynaecologists, or their mentors, were trained at a time when regret was more likely: women were more easily coerced; under five mortality was higher; serious congenital abnormalities were easier missed antenatally; IVF was not so mainstream; and women were on average much younger when they delivered their ≥2 child. Indeed, regret is not so much related to parity but very significantly to age (3). One can’t help but wonder if one woman with regret who is offered free IVF is worse: ethically; from a medical-complications perspective; and in light of financial considerations, than say 10 unintended pregnancies.
In the Commonwealth countries, Brazil, Spain, Switzerland (reputed to have the lowest induced abortion rate in the world), and the USA, most women know very well that a TL during a CS for a soon-expected-to-be-complete family is a popular option. This TO option is more or less understood to be on the table antenatally. Many doctors in the Netherlands, France, Germany, Eastern Europe and Belgium think it is unwise, unethical or even financially disadvantageous for them to offer the TO option under the above circumstances and most women are not well-informed enough to demand it or to insist. There is also very subtle TO counter-propaganda by cat food producers, where it hurts most, see photo (3). Not giving the TO option also has serious consequences for, for example, Africa where the medical norms are often related to those in Europe, where there is often no guaranteed access to a repeat CSs let alone NIPT and where millions of women have an unmet need for contraception and save abortion. A few court cases in Europe might help. In sub-Saharan Africa uterine scars can carry a similar risk to landmines: they can “explode” even 10 years after the last CS (3). Who knows whether the medical services will be in that particular region adequate then?

(1) Dickens B. Female contraceptive sterilisation: International Federation of Gynecology and Obstetrics (FIGO) Committee for the Ethical Aspects of Human Reproduction and Women's Health. Int J Gynaecol Obstet 2011;115:88–9.
(2) Verkuyl DA, van Goor GM, Hanssen MJ, Miedema MT, Koppe M. The right to informed choice. A study and opinion poll of women who were or were not given the option of a sterilisation with their Caesarean Section. PLoS ONE 2011;6:e14776. doi:10.1371/journal.pone.0014776. PMID: 21445338 http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0014776
(3) Verkuyl DA. Recent developments have made female permanent contraception an increasingly attractive option, and pregnant women in particular ought to be counselled about it. Contraception and Reproductive Medicine (2016) 1:23 DOI 10.1186/s40834-016-0034-1 (open access)

I find it strange that David A. Stephenson, Q.C., asks (12 May):

‘First, the decision in Montgomery purports to accord with the current (2008) GMC guidance on consent. If this is so, one might then wonder why change to the GMC’s guidance would be required in the light of Montgomery.’

Well, the Mental Capacity Act’s section 3 enshrined Informed Consent in English and Welsh law just before 2008: although the MCA does not use the term, it clearly did that [even if many people failed to notice].

Montgomery has more recently made it clear that Informed Consent is in fact the law for the whole of the UK (and has been since before the year 2000).

The GMC writes guidance which covers all of the UK.

Did I misunderstand why the question was posed [and I could not read the full article] ?

PS Although the above analysis is I think correct, I would point out that I consider the GMC's '2008 interpretation' of parts of the MCA - in particular how the Act applies to family carers - to be flawed, and therefore that it does need alteration.

Mike Stone mhsatstokelib@yahoo.co.uk @MikeStone_EoL