Afraid I don't know what they mean about Bolam and Montgomery tests! [Edited to add links of explanation at the end of this post.] But the need for consent to be based on being properly informed is so obvious it defies belief that, all these many years since consent became embedded in the legal/medical system, it is still necessary for papers like this.
It is iniquitous that patients have signed consent which is incomplete, inaccurate and misleading.
It continues to be iniquitous that thyroid hormone replacement post-thyroid surgery is not prominent in this paper.
Int J Surg. 2019 May 2. pii: S1743-9191(19)30098-6. doi: 10.1016/j.ijsu.2019.04.015. [Epub ahead of print]
A Critical Review of Thyroidectomy Consent in the UK.
2 Otolaryngology Department, Imperial College Healthcare NHS Trust.
Abstract
BACKGROUND:
In 2015-16, the National Health Service (NHS) Litigation Authority received 10,965 claims for clinical negligence with Surgery having the highest number of claims. Currently a sum amounting to 25% of the annual NHS budget has been ring-fenced to meet extant claims. Claims made on a basis of inadequate informed consent are increasingly seen with many achieving a successful plaintiff outcome. There are presently no UK guidelines for thyroidectomy consent.
METHOD:
A prospective study was performed to investigate current consent practice among the British Association of Endocrine and Thyroid Surgeons (BAETS) membership and patients having previously undergone thyroidectomy. For surgeons, the Bolam legal test applied where surgeons declared what risks and complications they routinely consented for during their practice. A study was also undertaken in patients who had previously undergone thyroidectomy for cancer applying the rule of Montgomery.
RESULTS:
Consent practice from 193 surgeons and data from 415 patients was analysed. In total thyroidectomy for cancer, 95% of surgeons consent for Recurrent Laryngeal Nerve (RLN) injury and temporary or permanent voice change. 70% specifically consent for External Laryngeal Nerve (ELN) injury, 50% for tracheostomy and 55% for general anaesthetic associated complications. Analysis of patient data showed they would like to be consented for far more risks than they are presently informed about in general medical practice. There was significant variation in the consenting practice in BAETS surgeons.
CONCLUSION:
A BAETS approved consensus guideline to standardise UK consent practice would be appropriate. This may reduce complaints, litigation claims and guide expert witnesses.
When I was doing sociological research before I got ill, the specific area was children's consent to take part in clinical trials. I was working in a group that was doing a lot of stuff around consent, but I was new to the field so was racing to catch up.
Since I've been ill I realise almost all the literature and research I was dealing with wasn't worth the paper its written on. I now really don't think there is much in medicine that most of us would consider high quality consent in normal life.
Its not even just about knowledge anddgunderstanding, although of course that is a large and difficult to achieve part. Consent can only be true and robust if people are completely free not to consent, to withdraw at any time, or to do so for 'stupid' reasons (I think that last one is very important. The person giving consent doesn't have to make a reasoned argument or persuade anyone - otherwise it's not their own consent decision). Not to mention, in a medical context, that there should be reasonable alternative treatment offered.
But as it is I think doctors choose the treatment they think is best, and patients get bundled through it in a box ticking exercsie. A big problem, to my mind, is that the whole of society just isn't good at talking about illness and treatments, so responses are very knee jerk. And because medics haven't had any philosophical ethics training, or studied the psychology of the situation, they are if anything more knee jerk than patients. This means they will be highlighting particular options as the correct one, even options that are often a bit naive or foolish. For example the way doctors assume everyone wants antibiotics, and contribute to a vicious cycle where people then do want antibiotics. I think a huge problem is that everyone tends to prefer aggressive treatments. Usually if a person is offered a choice between an aggressive treatment and a watch and wait., there's a huge imperative to choose the treatment. Altho I haven't seen any research on this, I'm suspicious doctors have a big influence over this.
Watch and wait suffers a major problem. The patient waits. No-one watches.
If, should things get worse, you can readily get another appointment, and then the appropriate treatment, it would be a step forward. If we had it explained what we should look out for, critical symptoms, etc., that might also help.
So much "home doctor" type of advice, even when it is published on the NHS website, persuades us to seek medical advice because it cannot bear the responsibility of being wrong.
The one thing that seems almost universally watch and wait is treatment for hypothyroidism! Mainly wait - until TSH is at least 10.
Being a sociological researcher I'm sure you ascertained that it depends who does the research that counts . In my thyroid journey I learned after having TT that research papers don't have that much credence as much as being our own lab rats .
You're right, its very important who does the research, and the findings will only be as hight quality as the question that is asked.
Interestingly, in that case I was working in a department of Public Health. They had incredible access to clinical trial units and other hospital departments. IAt first I could hardly believe it, as for sociologists getting access to things like hospitals is extremely difficult. But I eventually found out part of the reason - the Public Health field is enormously from the doctor's point of view and on the doctor's side.
I was trying to get a piece of research started looking at how doctors have emotions and can make human mistakes just like the rest of us, and it was seen as a very innovative thing to say!
The Montgomery case addresses most of the issues you posted about. So does the Mental Capacity Act 2010. Provided you have Mental Capacity no one can make decisions on your behalf. Only you make decisions about you. You are free to NOT take a course of treatment if you don't want it.
The case highlighted the fact that you can refuse or seek treatment that includes non medical reasons. the doctor only provides medical advice for you to consider taking in to account all your own factors.
I agree with you that that is the idea, but my view is that in real life this doesn't happen in a meaningful way.
Just the right to say 'no' is a very fragile and inadequate version of consent, because at the end of the day if people are sick and need treatment they need SOMETHING. It's not enough to have only the option to accept treatment, OR... Maybe nothing?
It's also my belief that patients are v rarely given all the information. A simple example is that it seems common practice, for thyroid cancer patients consenting to a thyroidectomy, not to mention that the full treatment includes RAI. This is only mentioned AFTER the thyroidectomy. Many courses of treatment proceed in this way. Its a lot easier for doctors not to have to explain the whole, lengthy treatment process.
Any time a doctor treats patients manipulatively, in my opinion, consent has been violated. Just as it would in a common sense context.
That is the struggle we have. A lot of doctors live in the past and are paternalistic in their approach.
The Montgomery case has blown that out of the water.
I accept that doctors should know this and adjust their practice. There some good doctors who do.
But a lot of doctors are professionally arrogant and wont change or adapt to patient knowledge or the courts. They will only change when threatened with formal action themselves. it is my view that patients have to initiate the first steps.
This is why patient support groups are so important.
To disseminate knowledge and therefore power.
To empower patients to challenge negligent behaviour and spread good practice.
To help patients challenge poor practice
But most of all to help patients on the path to recovery.
i am also aware that challenging poor practice is daunting at the best of times which is why I post as much as I do.
The information and the tools are out there. We have to learn to be positive and to use the information and tools.
My personal opinion is that we need a lot more... Perhaps even ethicists on staff (altho all my dreams require more money and resources). I just think doctors don't consider it their job to communicate with patients, and are more interested in getting through the their own treatment flowchart
I may agree with you but as I said before us patients are best placed to tell the doctor that he is not providing Good Medical Practice and not providing consent in the way that Supreme Court has ordered him to.
Why? because the Supreme Court recognised that patients are more informed about their diseases than they ever have been thanks to patient support groups and the internet. the GMC also accepts that patients know about their condition and expects doctors to listen to their patients. Even though many think they don't have to.
you are right. that is completely agaisnt the GMC guidance and the Montgomery case. any doctor who does not give the full information as you describe could face court action for negligence.
its up to us as recipients of negligent practice to challenge it and take formal action if necessary.
I have posted a lot about the Bolam test and the Montgomery test. The long route would be to trawl through them for detailed explanations
BUT
in essence, the Bolam test was a test to establish if a doctor was negligent in his practice. What the courts decided was that it the doctor followed course of conduct that was followed by a "respectable body of medical opinion", then the doctor was not guilty of negligence. In other words, if some doctors did the same thing as the accused doctor then the accused doctor was not guilty of negligence.
This judgement has been criticised over the years. It allows doctors regulate themselves taking the judgement away from the courts. It also allows bad practice. For an extreme example, if a group of doctors advocated prescribing drug x to pregnant women and drug x was known to cause birth defects, he would not be found guilty if he was doing what a respectable body of medical opinion would do. It also allows over reliance on guidance on guidelines resulting in defensive medicine at the expense of patients.
the courts recognised this in the Bolitho case and modified the Bolam test so that the "respectable body of medical opinion" must be logical. I have written about the need for logic in many of my posts, it WOULD be worth trawling for that. in short though, the current way most doctors diagnose thyroid disorders is not logical and therefore would not pass the Bolitho test.
However, in the Montgomery case the Supreme Court have overturned the Bolam test. It is no longer a "respectable body of medical opinion " that decides if a doctor is negligent or not. It is the courts who decide based on the evidence put before them.
The Montgomery case also clarified that the person who makes decisions about a patients care is THE PATIENT. A doctor can offer his expert help but the ultimate decision is the patients. This clearly has ramifications when a GP decides that he wants to reduce a patients thyroid medication. Again I have many posts on this.
So now, if a doctor doesn't give a patient ALL the treatment options about say the management of hypothyroidism such as T4, T4/T3 or T3 alone, he may be negligent in his practice because he is not allowing the patient to make an informed decision about her treatment.
This is why patients need to informed about their condition and the treatment options, and not be totally reliant on the doctor. as most forum users know, doctors do not know a lot about thyroid matters and therefore are likely to be negligent. the Supreme Court was very careful to acknowledge the role of the internet and support groups as sources of information.
The Montgomery case is one of the most important medical cases in recent times.
I think that all the administrators of patients support groups should read the judgement of the Montgomery case. It is written in plain English and is one of the most accessible medical judgements I have read. The link is here supremecourt.uk/decided-cas...
The work of Diogenes and Professor Rudoelf Hoermann, the work of the late Dr John Lowe and the books by Paul Robinson is a good starting point!!
Most of this has been posted on this site.
Their work logically dismantles the unthinking doctors mantra on using TSH as the only diagnostic tool, not treating patients whose lab results are within the reference range and only prescribing T4 and shows it to be illogical.
Even the BTA is changing its tune. One of their last research papers showed that most GPs in their survey over relied on TSH for diagnosis and did not consider signs and symptoms - in their opinion.
The information is out there, we need to use it properly.
How do we use it? We use the information to counter the bad doctors claims, by referring to Bolitho, Montgomery, the doctors Code of Practice "Good Medical Practice" and the Mental Capacity Act.
Ok do you have a link to the bta research by any chance. I saw one along those lines I think published in BJGP, but it was talking about over-reliance on tsh over symptoms in treatment and monitoring rather than diagnosis.
That's the one I'm thinking of. i'm at work now so i don't have access to the material but a search of my posts and diogenes' posts will offer up lots of the material i have in mind.
Plus there are lots of other posts with evidence on relying on TSH is illogical. the search box is on the top right of the page.
The full article is not available so I cant see the full range of what they are consenting for.
It is alarming that they think the Bolam test is still applicable in some consent cases but not in others but still are aware of Montgomery.
It appears that they are only discussing the risks of injury during surgery. I think that they should be discussing risks and benefits of all forms of treatment after surgery with patients.
A quick look at the BAETS website and their guidance for surgeons shows they are behind the times with regard to recent advances reported on this forum.
Medical negligence lawyers will rubbing their hands!!
To be honest, this is the first time I've heard of the BAETS being focused on the BTA. it should be another group of doctors that the patient support groups need to reach out to.
It really hit me when you said "It appears that they are only discussing the risks of injury during surgery.". It think this immediately highlights one of the huge issues with how consent works in practice.
The medics are only considering a very limited range of risks, and reasons patients might decide not to consent. Which pushes the notion of consent into this very limited domain.
A counter example of some of the issues that came up working with children: wanting to miss as little school as possible, wanting to take part in sports teams or other activities that helped them feel like a normal child, difficulties of parents hoping/needing to work being interrupted by driving their sick child to appointments all week.
These 'soft' issues tend to be ignored by both medics and public health researchers.
which is what Montgomery was about. it appears that the doctor for Mrs Montgomery withheld information regarding the birth of Mrs Montgomery's child. This is similar to the thyroid surgeons not discuss treatment options after surgery. As we know may thyroidectomy patients suffer from hypothyroidism that is under treated with only T4.
Not discussing treatment after surgery is negligent in my view.
the surgeons will try to update their consent guidance in the hope that they can rely on the guidance as a Bolam type defence if things go wrong - i.e. most other surgeons (a body of respectable medical opinion) would do this surgery or only talk about risks to surgery. But Montgomery has supported the notion that the doctors must discuss ALL risks. in my view, this includes treatment after surgery. To not do this would be negligent - in my view.
55% for general anaesthetic associated complications
We see (both here and over on Pernicious Anaemia Society) questions over the impact on nitrous oxide on B12. This could easily be classed as a general anaesthetic complication. But as it is a known effect of nitrous oxide, it is known (at least by the anaesthetist) whether nitrous oxide was used, and there should be fairly straightforward ways of ameliorating the issue. (Whether that is by taking B12 tablets for a month, an injection or two, or some other approach. Surely it is known how best to tackle this?)
It shouldn't be a complication as such, it should only be an issue if the required care is not delivered simply because the rest of the time that care is properly delivered. Shame that seems very much not to be the case.
I’ve had Graves for 7 years with 2 relapses. Every time I see the Endo he pushes for RAI or TT surgery. Never once have any of the risks been explained to me, I only know what I have found out from my own research. He says breezy things like “let’s get our excellent surgeon to whip it out for you”. Like I’m having a stray hair plucked out or something similar. I always politely refuse and ask to stay on low dose ATDs (perfectly safe long term as per latest research). I always get a very loaded reply “well it’s the patient’s choice of course” in such a tone as to suggest it’s anything but, and he’s just humouring me until I eventually see the light and give in. I personally think it’s quite deliberate that they don’t lay out all the risks carefully, as they’d have a much lower take-up on definitive procedures if they did. Oh wait, he does continually bang on about the (very low) risk of complications with ATDs, and warns that I’ll develop TED if I don’t act soon, in the vain hope that it will scare me into doing the other options. When I pointed out TED could actually be triggered by RAI or surgery he said I was wrong (a lie). He complained about how big my file was getting the last time I saw him; I kid you not, it was a slippery fish with about 10 pieces of paper in it. He’d have a fit if he saw the size of the files I keep on my health journey at home! The point is, they’re just trying to get rid of you off their books back into primary care in my experience. Informed consent has nothing to do with it. Let’s scare them off the things we don’t want them to do, and sugar coat the things we do want.
Thanks for writing up such a detailed description of your experience. This is very similar to my experience with consultants and treatment.
Doctors actually have quite strong opinions on which treatment the patient should opt for, and they make no secret of it. What makes me angry is all the patients in exactly your situation, seeing that Endo, but who don't have the ability to do the research you've done and stand up for themselves. They'll all have given into it and had their thyroid whipped out, because that's what he's pushing
I agree with you that getting us off their books is a big motivator, and a careful balance of the risks and benefits and our own individual set of needs is not as important And they know their arse is covered because they're pushing for the most conventional treatment, even if it's not ideal for us.
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