Informed Consent

Given the recent admission
Andrew Goddard:
"There is reasonable evidence, for example, that graded exercise therapy helps a group of patients with ME/CFS and, while not without risk, our experts strongly support its ongoing use as an option in this condition".


from NHS website

"
Overview - Consent to treatment


Consent to treatment means a person must give permission before they receive any type of medical treatment, test or examination.

This must be done on the basis of an explanation by a clinician.

Consent from a patient is needed regardless of the procedure, whether it's a physical examination, organ donation or something else.

The principle of consent is an important part of medical ethics and international human rights law."

"
Defining consent
For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision.

The meaning of these terms are:

• voluntary – the decision to either consent or not to consent to treatment must be made by the person, and must not be influenced by pressure from medical staff, friends or family
• informed – the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead
• capacity – the person must be capable of giving consent, which means they understand the information given to them and can use it to make an informed decision"

https://www.nhs.uk/conditions/consent-to-treatment/

does this not apply to GET?


see also
https://www.s4me.info/threads/evide...e-imperatives-of-informed-consent-2016.21089/

@Valerie Eliot Smith

eta: I was prompted to start this thread after watching some of the recent interview of James Badenoch QC by the RSM

Code:

https://www.youtube.com/watch?v=ag4DPjdF5H4

 

@Sly Saint See edits - have tried to clarify a bit.

Thanks, @Sly Saint

Informed consent [ETA: or lack of it] is one aspect of medical negligence. It would be for any legal team conducting an action on behalf of an ME patient who was alleging harm as a result of GET to decide whether consent is an issue in the case. That decision would depend on the available evidence.

I haven't watched the video you mention but I would guess that James Badenoch talks about the Montgomery case from 2015. It was certainly a significant case but, as a Scottish case, it is only persuasive, not binding in English law.

In any event, there have been further cases on informed consent since then and things have moved on (in broadly the right direction).

Brain-fog bad - hope that makes sense. Not at my most eloquent today!

ETA: informed consent doesn't operate proactively. If you know enough to reject treatment then, by definition, you must be "informed". If you don't, and you accept treatment which can later be shown to have caused harm, then it may form part of an action in medical negligence, depending on the circumstances and evidence (as above).

 

For those unfamiliar with the Montgomery v South Lanarkshire case a summary from BMJ ( though still 2017 so may be further nuances)

https://www.bmj.com/content/357/bmj.j2224

And Supreme Court summary
https://www.supremecourt.uk/cases/uksc-2013-0136.html

 

I am not sure what 'operating proactively' means but perhaps Valerie can clarify.

At least when I practiced most medicines were given without any formal consent process. The patient should have been informed of the reasons for taking the treatment but they did to sign a form to say they had been informed. They did for surgery or spinal injections or trials but not for medicines or physio. I don't know about CBT.

I indicated in my evidence to NICE that I thought continued use of GET was unethical. I still do. The proposed guideline does not recommend GET. But it does allow activity management.

I would not want to add a suggested information sheet for GET to the guideline. However, thinking about it one might suggest adding an information sheet template for any physio programme for ME, indicating the information that would be minimum for informed consent.

So one could start considering what such an information sheet should include.
Perhaps to start with it should include a statement indicating that we have no reliable evidence either way as to what sort of activity level should be recommended but large numbers of patients have found that limiting activity in a pacing format serves them best.
I think the sheet should also include a statement that the evidence for using incremental or increasing activity/exercise as a way to recovery is not supported by any reliable evidence, with trials tending to suggest that there is either no benefit in terms of being able to do more or too little benefit to be worthwhile. Moreover, large numbers of patients report being made worse by exercise programmes.
It could include a statement about increasing activity for patients who feel well enough to do so, as a plan for returning to nearer normal activity once well enough, which might also include cautions about patients experiencing worsening if they do not take things very carefully. (In other words that feeling well enough may not be enough to be sure relapse wi not occur with activity.)

I don't even know if any of the ME service departments have information sheets at present.I guess maybe they do. It might be fairly easy to demonstrate that they are not providing adequate information for informed consent.

 

afaik the only thing that patients have been informed of is that increase in pain and fatigue post activity is 'perfectly normal', and if the patient experiences any deterioration all that is required is to go back to 'baseline' and try again.

(The WHO guidelines for Long Covid patients included a section warning against exercise if they have post-exertional malaise (PEM)
https://www.s4me.info/threads/nice-...ue-17th-august-2021.21897/page-81#post-369828)

 

Scanning on Google is interesting. Information packs seem to give no indication of the grounds for GET or risks. One says:

You may be worried that any increase in exercise or physical activity could make your condition worse. Be reassured - research has shown that a guided, gradual exercise programme can help people who suffer from CFS/ME without causing ill effects.

 

Pretty incriminating I'd think.

 

Also @Sly Saint

Apologies - I'm not explaining this very well. Informed consent is an issue which is raised on a regular basis in the ME patient community - with good reason.

As with many legal questions, the answer is not straightforward (and would be explained differently by different lawyers). It is difficult to address effectively in this format - it's easier in a live lecture/seminar so questions can be answered as they arise. I'll give it another go!

Informed consent (or lack of it) becomes an issue after the event - ie. after harm has been caused. If no harm has been done, then it doesn't come into play, other than in general compliance with the guidance of the professional bodies (eg. GMC) and healthcare practitioners' common law duty not to cause harm.

The case law, as in Montgomery (now superseded by more recent English cases), is dealing with cases where the harm has already been caused and the patient is claiming they were not properly informed about the risks, either deliberately or negligently. All the case law in the world isn't going to prevent a lack of informed consent in advance. It can only be used to clarify the law and address the harm caused afterwards.

As a matter of common sense, HCP's will not be deliberately risking their practices by failing to comply with their general duty to provide proper information to patients about treatment, however informal that process may be, as @Jonathan Edwards says.

If an HCP treats a patient with GET and the patient complains, then, as things stand at the moment, the HCP simply points to the still current 2007 NICE guideline and says, quite legitimately, "I was only following this guideline which doesn't say that this treatment is harmful".

As to the wider issues of NICE's liability for harm caused, that's where the situation becomes more complicated. I've alluded to it in some blog posts and I'll leave it at that because that is a separate complex legal question which would need specialist advice and possibly a novel approach to be constructed. It might be possible - but I'm not sure how with the way things stand at the moment.

However, this is where the ForwardME 2019 patient survey on harm from GET becomes very important because a) NICE requested it for the guideline review and b) NICE has been on notice since then of the potential for harms with GET (although patient surveys have a limited evidential value).

Treatments recommended by NICE are prima facie not unlawful unless and until the recommendations change (contrary to what some people are saying on social media). That is why this is such a critical time for the ME community.

It's imperative that the focus right now should be on the failure of due process in the fiasco of recent events.

--------------------------------------------------------

On a separate note: I'm going into hospital tomorrow for an operation so I won't be around much for the next week or two.

 

@Valerie Eliot Smith, thank you for all the effort you are putting into informing us on these issues and best wishes to you for tomorrow onwards.

 

Thank you for that clarification @Valerie Eliot Smith

 

But the 2007 NICE CFS/ME guideline specifies:

So surely this means that the guidelines even back in 2007 recognised that there were potential risks involved in GET, or am I missing something?

 

An example of NICE's response to the below stakeholder concern to GET in the 2007 draft.

Example stakeholder comment (BRAME Blue Ribbon for the Awareness of ME):

Example NICE's responses:

These comments come from Chapter 6 of the table of 2006 stakeholder comments, there are several similar comments made by NICE in relation to the concerns raised by patient groups to GET.

 

many thanks @Valerie Eliot Smith ; hope all goes well with your op.

 

Most, if not all the young people are given no option but to take up the treatment, how does this impact on the young patient and their families where the use of fabrication or inducing illness is used as a control on the parent? The other issue is taking diagnosis away from the young person. So let us say the young person was diagnosed with ME/cfs but took it away and refused to write down their other diagnosis as this would label them in later life?

 

Not sure I understand the question but a couple of links from another thread may help: : https://www.nhs.uk/conditions/consent-to-treatment/children/ and https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4962726/

 

Not so much a question as a statement of facts.

Young people are not afforded consent as they are not given the opportunity and cannot refuse treatment and therefore have no means of consent.

 

So - as per the links, how does that happen in the UK contrary to Gillick competence ? I'm not saying there aren't problems I'm just trying to understand how it can be so absolute given that there are independent points of support e.g https://www.pohwer.net/childrens-and-young-peoples-advocacy

 

FII cases seem to have some geographical specificity .
Not consenting can have serious consequences. For many it is Hobson' s choice.

The FII procedures had input from EC' s team.

 

It is good to ask questions and make it as clear as possible.

The Social Services are being reviewed and I am not sure they realised the enormity of the problem and ME is not the only complex condition that is being targeted the Autistic society are aware of the issues and the problems which is not ideal

Family Courts are known to have problems too and rely mostly on community paediatricians 101 things to say about that too but we need to focus on the issues of ME.

In most cases young people are denied advocates, and anyone who supports them against all the legislation and the laws are taken down to.

The second issue with Advocates is that they are mostly given the title of independent but are paid by the LA. There is no one who is truly independent working for the YP and they may never meet their solicitor.

There is a statutory framework for provision of children's independent advocacy, England but who is making sure it works for the children? There is no scrutiny and no redress when things go wrong.

As an Advocate with 8 years experience I know more about the legislation law and what a Social Worker should do than almost all those in the industry.

If the information is wrong and there is no accountability, scrutiny and transparency, with full control in the hands of the services backed by the LA it does go horribly wrong. You think the PACE trial or the way Prof Crawley behaves is bad you have not seen anything until you sit in a child Protection meeting or a family meeting with those who quote the research to young children or young people and blame the parents.