Too much information?

Too much information?

Too much information? Pro-VIDE Law, 1/10/2015 @ Weightmans, Liverpool. Participants Mr. Charles Feeny, barrister; Prof. Graeme Poston, Consultant Hepatobiliary Surgeon; and

Prof. Gus Baker, professor of ClinicalNeuropsychology at the University of Liverpool. The question in a nut shell Hippocratic Corpus Physicians are advised to reveal nothing to the patient of their present or future condition, for many patients through this cause have taken a turn

for the worse. Decorum XVI of the Hippocratic Corpus. Sidaway v Board of Governors of the Bethel Royal Hospital [1985] AC 871 3 different approaches coming out of the case. If, therefore, the failure to warn a patient of the risks inherent in the operation which is recommended does constitute a failure to respect the patients right to make his own decision, I can see no reason in principle

why, if the risk materialises and injury or damage is caused, the law should not recognise and enforce a right in the patient to compensation by way of damages. Per Lord Scarman at page 884-885. I am of opinion that the judge might in certain circumstances come to the conclusion that disclosure of a particular risk was so obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it. The kind of case I have in mind would be an operation involving a substantial risk of grave adverse consequences, as, for example, the 10% risk of a stroke from the operation In such a case, in the absence of some cogent clinical reason why the patient should not be informed, a doctor, recognising and

respecting his patients right of decision, could hardly fail to appreciate the necessity for an appropriate warning. Per Lord Bridge at page 900. Finally Lord Diplock But when it comes to warning about risks, the kind of training and experience that a judge will have undergone at the Bar makes it natural for him to say (correctly) it is my right to decide whether any particular thing is done to my body, and I want to be fully informed of any risks there may be involved of which I am not

already aware from my general knowledge as a highly educated man of experience, so that I may form my own judgment as to whether to refuse the advised treatment or not. Per Lord Diplock at page 895 Chester v Afshar [2004] UKHL 41 The Claimant suffered from back pain. Three days after consultation with Mr Afshar the Claimant was operated upon. It resulted in significant nerve damage and left her partially paralysed.

There was a 1-2% risk associated with the surgery. The Claimant was not informed of this risk and the trial judge accepted that the Claimant would not have had the operation immediately but would have had it at a later date. 3:2 split in the House of Lords (Lords Bingham and Hoffman dissenting). But if failure to warn and the occurrence of injury which should have been

the subject of the warning are, without more, enough to found a successful claim, the claimant would presumably succeed even in a case like Smith v Barking, Havering and Brentwood Health Authority [1994] 5 Med LR 285 , where it is found on the balance of probabilities that the claimant would have consented to the operation even if properly advised. That seems to me, with respect to those who hold otherwise, to be a substantial and unjustified departure from sound and established principle. Per Lord Bingham at paragraph 9. Montgomery v Lanarkshire Health Board [2015] UKSC 11 The Claimant sought damages from the Health Board on

behalf of her son who suffered severe problems as a result of shoulder dystocia. The Claimant was of small stature and diabetic. The treating doctor did not tell her that diabetic women had a 910% risk during a vaginal delivery of shoulder dystocia as, in her view, the risk of a grave problem resulting for the baby was very small and, if the condition were mentioned, most women would ask for a caesarean section, which was not in their interest. 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 test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patients 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. Per Lords Kerr and Reid at

paragraph 87. Implications What are the implications of Montgomery? Informed consent: where are we now? Graeme Poston Professor of Surgery

University of Liverpool Consultant Surgeon Aintree University Hospital, Liverpool A long time ago. I qualified in 1979 Informed consent in 1979 was signing a simple consent form stating the name of the proposed procedure, signed by the patient/guardian and countersigned by a doctor This remained largely unchanged until about 2000

In 2000 The consent form changed In addition to stating the proposed procedure, it now had to state: - the intended benefit(s) of the procedure - the well-recognised commonly occurring risks and complications of the procedure The assumption was that all wellrecognised complications that occurred with a frequency of >1% would be listed In 2000 The consent process changed

Whereas previously consent could be obtained by any doctor, regardless of grade and specialty, it now had to be obtained by a doctor of appropriate seniority and experience to understand the procedure, its risks and benefits (but not necessarily to be able to do it unsupervised) Ideally consent should be obtained at some time before the procedure, and certainly >24 hours beforehand In 2000 The consent process changed But did not take into account material

risk: - Chester v Afshar Montgomery v Lanarkshire Health Board What then constitutes material risk in the light of: - Sidaway v Bethlam and the Maudsley? - Bolam v Friern Barnet? Hunter v Hanley? - Issues in Montgomery v Lanarkshire Mrs Montgomery studied molecular biology at

Glasgow University and had a BSc She worked as a hospital sales representative for a pharmaceutical company Both her mother and sister were medical practitioners She was an insulin dependent diabetic of short stature In 1999 she was expecting her first baby It is well-established that diabetic mothers tend to have larger than average sized babies Issues in Montgomery v Lanarkshire

Issues in Montgomery v Lanarkshire There was a misinterpretation of the antenatal imaging, leading to an inappropriate assumption that Mrs Montgomerys baby was not large for dates As such the risk of shoulder dystocia was never discussed during the pregnancy A decision was made to offer Mrs Montgomery an induced vaginal delivery in the 38th week of her pregnancy Issues in Montgomery v

Lanarkshire At 5.45 pm, during this attempted vaginal delivery the baby became impacted in Mrs Montgomerys pelvis (bilateral shoulder dystocia) This was only realised when half of the babys head had already delivered Dr McLellan had never dealt with this situation before, and applied significant traction to deliver the head During this time the placenta detached from the uterus so the baby was now being deprived of oxygenated blood

Issues in Montgomery v Lanarkshire No preparation had been made to convert from a vaginal delivery to a Caesarian section delivery Eventually, with just a huge adrenalin surge, Dr McLellan succeeded in pulling the baby free, and delivery was achieved at 5.57 pm. The baby had been deprived of oxygen for ~10 minutes and suffered: - cerebral palsy due to the oxygen deprivation - bilateral Erbs

palsies, both arms paralysed due to brachial plexi injuries because of the trauma of the delivery Issues in Montgomery v Lanarkshire Antenatal care: It was contended that Mrs Montgomery ought to have been given advice about the risk of shoulder dystocia (the inability of the babys shoulders to pass through the pelvis) which would be involved in vaginal birth, and of the alternative possibility of delivery by elective caesarean section.

The delivery: It was contended that Dr McLellan had negligently failed to perform a caesarean section in response to abnormalities indicated by cardiotocograph (CTG) traces. Issues in Montgomery v Lanarkshire According to Dr McLellans evidence, in some cases the mother may be entirely unaware that shoulder dystocia has occurred. Dr McLellan gave evidence: since I felt the risk of her baby having a significant enough shoulder dystocia to cause even a nerve

palsy or severe hypoxic damage to the baby was low I didnt raise it with her, and had I raised it with her then yes, she would have no doubt requested a caesarean section, as would any diabetic today. Judgement in Montgomery v Lanarkshire Mrs Montgomery was told that she was having a larger than usual baby. But she was not told about the risks of her experiencing mechanical problems during labour. In particular she was not told about the risk of shoulder dystocia.

It is agreed that that risk was 9-10% in the case of diabetic mothers. Unsurprisingly, Dr McLellan accepted that this was a high risk. But, despite the risk, Dr McLellan said that her practice was not to spend a lot of time, or indeed any time at all, discussing potential risks of shoulder dystocia. Judgement in Montgomery v Lanarkshire Dr McLellan explained that this was because, in her estimation, the risk of a grave problem for the baby resulting from shoulder dystocia was very small.

She considered, therefore, that if the condition was mentioned, most women will actually say, Id rather have a caesarean section. She went on to say that if you were to mention shoulder dystocia to every [diabetic] patient, if you were to mention to any mother who faces labour that there is a very small risk of the baby dying in labour, then everyone would ask for a caesarean section, and its not in the maternal interests for women to have caesarean sections. Judgement in Montgomery v Lanarkshire

Dr McLellan explained since I felt the risk of her baby having a significant enough shoulder dystocia to cause even a nerve palsy or severe hypoxic damage to the baby was low I didnt raise it with her, and had I raised it with her then yes, she would have no doubt requested a caesarean section, as would any diabetic today. Issues in Montgomery v Lanarkshire Counsel for the Defender to Mr Stewart, one of the Claimants Experts:

And if Dr McLellan had said your baby appears to be on the 95th centile or whatever, so its borderline large, it's the top end of the normal size, its largish We know that you are diabetic. We know you are whatever height you are, we've estimated the size as best we can all the way through, there are risks but I don't think the baby is so big that vaginal delivery is beyond you and I think we should try for vaginal delivery and if anything comes up we will go to caesarean section. Now if that was the general tenor of the discussion, could you criticise that? I know it's very vague and it's very difficult because it's another hypothesis, Mr Stewart and I appreciate that but yes I would ... are you able to answer that question?

Consent: the view of the GMC The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. The patient weighs up the potential benefits, risks and burdens of the various options as well as any non-clinical issues that are relevant to them.

The patient decides whether to accept any of the options and, if so, which one. Consent: patients and doctors making decisions together (2008)(para. 5) But how does a patient view risk? Especially material risk? If you were going on a picnic this afternoon and the chance of rain was 10% you would probably go? If you were flying to New York this afternoon and the chance of the plane crashing was 10% you probably wouldnt board it? Clinical risk sits somewhere between these two extremes and depends on:

- the significance of the benefit to be gained (e.g. cured of cancer) - the impact of the known complications, if they were to happen But how does a patient view risk? Especially material risk? All surgery carries risk of complications For major operations this is ~40% for all risks Some are generic e.g.: - wound infection - bleeding - DVT/PE complications relating to general anaesthesia

Some are operation specific e.g.: - bile duct injury during cholecystectomy - chronic pain after groin hernia surgery - 10% operative mortality for cholangiocarcinoma surgery But how does a patient view risk? Especially material risk? How does the patient balance risk vs benefit? Risks: Operative death Heart attack Stroke

Major incapacity Benefits: Cured of cancer Relief from pain Restoration of function Ability to work Future consent form? State the condition as well as the procedure? State the intended benefits? State the material risks as agreed between clinician and patient? (but how assessed?) State the probability of the proposed treatment

being successful, especially in cancer surgery? State the alternative treatment strategies, including doing nothing? State the risks and successes of the alternate strategies, including doing nothing? But does this go beyond just informed consent? In 2005 the Parliamentary Health Select Committee produced a report critical of the NHS because 25,000 people were dying from preventable and treatable veno-thrombotic embolism (VTE) each year following admission to English hospitals.

The Committee instructed NICE to issue guidance to attempt to reduce the incidence of this problem NICE issued guidance (CG46) in 2007 which identified patients at high risk for VTE, how to evaluate them, and how to offer VTE prophylaxis But does this go beyond just informed consent? However, nearly 25,000 people a year kept on dying NICE reconvened the Guideline Development Group who published further guidance (CG92) in January 2010 This guidance was very similar to CG46 but with the

additional statement that patients not deemed to be at high risk of VTE but were being admitted to a hospital bed should be advised, ideally in leaflet form, of the symptoms of VTE (swollen painful calf, painfully coughing up blood) prior to discharge if so then seek prompt medical attention But does this go beyond just informed consent? Mr Spencer was a 49 year old senior manager with no significant or relevant past medical history In January 2010 he presented to Hillingdon Hospital with a symptomatic right inguinal

(groin) hernia When examined he was found to have an asymptomatic left inguinal hernia as well He was listed for laparoscopic repair of both hernias under general anaesthetic But does this go beyond just informed consent? He was on the cusp of being at higher risk of a VTE in a number of areas: - BMI 29.7 (limit <30) - abdominal procedure (laparoscopic v open surgery) - anaesthetic

possibly >60 minutes However no VTE assessment was undertaken but pneumatic boot were placed during surgery At surgery on 1st February 2010 the laparoscopic procedure was abandoned due to bleeding, and the symptomatic left side repaired using traditional open surgery But does this go beyond just informed consent? He was discharged to home later that day with a generic patient information form stating that if he had concerns then contact either the day unit or the hospital switchboard

Mrs Spencer contacted the day unit on 2 occasions: - 1st post-op day because of confusion - 3rd day because of wound redness On the 5th day his left calf became swollen and painful which he ascribed to stiffness from being bed-bound, it appeared to resolve spontaneously But does this go beyond just informed consent? On 23rd April he suffered a massive near-fatal PE, for which he was anticoagulated

Two weeks later suffered further PEs and is now anticoagulated for life Mr Spencer argued that regardless of how small the risk of VTE, had he been told of the symptoms to look out for, he would have proceeded with surgery, but would have sought immediate medical help when his calf became swollen He would have required anticoagulation, but on balance, would have avoided the PEs, and subsequent lifetime anticoagulation (and its But does this go beyond just informed consent?

It was not accepted by the Defendant in the course of the trial that Mr Spencer suffered the symptoms he described in his legs shortly after his discharge home. His Honour Judge Collender QC observed: Mr Spencer gave a reasonable explanation as to why he did not make the association; he attributed the calf symptoms simply to being laid up as a result of the operation and not taking exercise. The fact that the symptoms were remote from the operation site is of significance. But does this go beyond just informed consent?

Professor Poston giving evidence on behalf of the Claimant said: The Guidance is intended to encompass those patients on the cusp of the very specific risk factors for increased risk of DVT stated in both guidelines, which in the Claimants case was at attempted laparoscopic procedure, an anaesthetic time of just under 1 hour in a patient whose BMI was just less than 30. But does this go beyond just informed consent? Mr Thomas giving evidence on behalf of the

Defendant said: In my opinion the best advice is to say that if the patient does have any further or future problems, that they should contact the GP or A+E department. It is impossible to either ask or give advice as to every possible complication that can occur after hernia operation or anaesthetic. The list would be huge furthermore the patient would not be able to take such a list in. Therefore patients are only warned or questioned over common complications after such surgery. But does this go beyond just informed consent?

HHJ Collender QC considered: In the light of the Montgomery decision already discussed above, I would express the test that I should apply to be the Bolam test with the added gloss that I should pay regard to what the ordinary sensible patient would expect to have been told. Put in the form of a question, the test I consider to be, would the ordinary sensible patient be justifiably aggrieved not to have been given the information at the heart of this case when fully appraised of the significance of it? But does this go beyond just informed consent? HHJ Collender QC considered:

I ask myself the question, would the ordinary sensible patient expect to have been given the information contended for; put another way I ask myself, would such a patient feel justifiably aggrieved not to have been given on discharge the information contended if appraised of the significance of such information. I consider that, on the evidence before me, the answer to both questions should be in the affirmative. But does this go beyond just informed consent? HHJ Collender QC consided:

I consider that modern, safe and responsible medical practice should be to give such advice to patients undergoing general anaesthetic. to inform such patients of the very particular signs and symptoms of those conditions is a precaution that can save lives and should be given. HHJ Collender QC ruled in favour of the Claimant Consent: Psychological perspective The process of making a decision Professor Gus A Baker

Professor of Clinical Neuropsychology Simple decision! G&T Vs Wine Complex decision Australian Chardonnay

Pinot Noir What decisions do clients have to make when giving consent? Clinical Decisions relating to consent treatment Decisions in relation to instructing legal representatives Decisions in respect of managing finances. Decision Making How do people make decisions in relation to consent?

How do they sift through the information without drowning in a sea of alternatives? And what are the factors that lead them in a certain direction? 48 Capacity in a Clinical Setting Neuropsychological factors Memory Attention/ concentration

Crystallised intelligence Dysexecutive syndrome Case of Mr P Personality Factors Introvert versus Extrovert

Confident versus lack of confidence Risk taker versus non risk taker Optimist versus pessimist Vulnerable or not Emotional factors Depression Anxiety

Low self-esteem Case of Mr S [no decision] Authority figures The individual Partner

Judge Headmaste r Barrister Lawyer Parent Jacoby and Baker study Importance of the decision

Major medical procedure Large amounts of money Personal relationships OUTCOMES How can we help Improve understanding of risk by: Provide simple but appropriate explanation of the decision to be made Discuss the risks of making or not making a decision

Discuss the potential outcomes of the decision Ask the decision maker to feedback about their understanding of the decision Allow time for further consideration and/or discussion with others Summary Determine the question that needs to be addressed or the consent that has to be given Consider multiple information sources Consider the individual [intellect, personality etc]

Rehearse the decision stages Rely on your own judgment about whether the person is capable of making a decision or giving consent 55 Decision making

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