Informed consent deserves a little less respect

The conclusions of a ‘citizens’ jury’, reported recently in the British Medical Journal [1] shed light on some important weaknesses in the doctrine of ‘informed consent’. The doctrine is commonly thought of as canonical. Be careful about questioning its exalted status: you’ll be branded paternalistic at best, and the indictment may well involve unflattering comparisons with Dr. Mengele.

The ‘jury’, composed of 25 women,  commented on how a leaflet on breast cancer screening should be re-drafted. The jury preferred:

- the term ‘overtreatment’ to ‘over-diagnosis’

-to express benefits in the language of lives saved rather than deaths avoided

- to talk about ‘benefits’ and ‘risks’ rather than ‘pros’ and ‘cons’

- to begin the leaflet by an up-beat reference to the numbers of lives saved by screening, followed by the caveat that a small number of women would be over-treated.

What was the priority: reassurance or accuracy? The majority (15), wanted both; 3 thought that reassurance was most important; 7 thought that accuracy was the priority.

How should one list the benefits and harms? Four thought they should be listed together in the same sentence, 8 that they should be listed separately, and 12 for mentioning them first separately and then together.

The point of all this  is that there are innumerable different ways, all of which would be smiled on by Bolam [2], in which entirely accurate information can be conveyed. And yet tiny nuances are seen by the receivers of the information as significant.

This, of course, is common knowledge. I just cycled past a van which bore the slogan: ‘Bringing you the internet at up to 10GB [presumably per second]’. A slogan that said instead ‘Bringing you the internet no faster than 10 GB per second’ would have been vetoed by the company and would induce fewer contracts. The two slogans, obviously, make identical claims. Similarly  in medicine and surgery. You want to dissuade a patient from an operation? Tell her that 1 per cent of patients die on the table, and that, if she survives, there is only a 60% chance that the procedure will relieve her pain. You want to persuade her to have it? Tell her that the chances of dying intraoperatively are very, very small – just 1 per cent – and that the procedure is likely to render her pain free for life.

It’s not just linguistic nuances that matter. In fact, since the evidence suggests that only a fairly small proportion of verbally communicated information sinks in [3]  (we tend to hear either what we want to hear or what we fear hearing), non-verbal cues are crucially important. A raised eyebrow is worth any number of elegantly summarised RCTs.

Lawyers and ethicists have spent millions of words dissecting and refining the idea of informed consent. Of course the doctrine is  important. Some terrible things were and are done in the name of  paternalism. But the way in which medical information is necessarily transferred means that the doctrine cannot, in practice, have anything like the philosophical purity that warrants the theoretical refinement on which so many academic reputations have been built. What’s the point of blending your colours with exquisite care if, when you come to paint with them, you have to paint with a brush so big that they’re all mixed together?

So: keep the doctrine. It’s a vital bulwark against some nasty abuses, and an important vehicle for expressing the importance of patient autonomy. But don’t give it a status that, because of its rather iffy performance on the wards, it doesn’t deserve.

Exaggerated respect for informed consent can be dangerous in several ways. One is that it can make doctors jumpy. They can concentrate so hard on disgorging the information that they think will keep the lawyers off their backs that their humanity haemorrhages away at a time when  it is often needed the most. Informed consent can crystallize clinicians into technicians. Patients, as Onora O’Neill noted, [4] generally want to be able to trust their doctors far more than they want to have laid out before them the lavish smorgasbord of  clinical information that informed consent tends to suggest is mandatory. Patient appetite for that smorgasbord is likely to be suppressed by the inevitable circumstances of the consultation. Yes, accurate information provision is a part of that trust, but not the greater part.  Giving patients what they want in terms of a humane, sympathetic, trustworthy doctor shows much more respect for patient autonomy than the gabbling of a data sheet or the tedious rehearsal of audit statistics.

One legal corollary of this is that the Bolam test should apply without caveat to civil claims  involving the provision of information to patients. Lord Scarman (who, in the cornerstone case of Sidaway  [5] questioned Bolam‘s rule in such cases) has been in the ascendant over the last couple of decades [6]. His judgment should  be relegated to a box of legal curiosities so that it can no longer steal doctors’ sleep. Only Bolam knows what it’s really like out there. It allows decent doctors to be themselves, which is what patients generally want them to be.

References

1. BMJ 2012; 345:e8047 (1 December 2012, p. 6)

2. The principle in Bolam v Friern Hospital Management Committee [1957]  2 All ER (cp Bolitho v City and Hackney Health Authority [1998] AC 232, is that a doctor is not negligent if what he has done would be endorsed by a responsible body of medical opinion in the relevant specialty.

3. See, for instance, Turner P and Williams C, ‘Informed consent: patients listen and read, but what information do they retain?’ NZ Med J 2002: 115(1164); U218; Scheer et al, ‘The myth of informed consent in rectal cancer surgery: what do patients retain?’ Dis Colon Rectum 2012: 55(9); 970-5; Lemaire R, ‘Informed consent: A contemporary myth?’ J Bone Joint Surgery Br 2006: 88 – B(1); 2-7

4. Autonomy and Trust in Bioethics (Cambridge, CUP, 2002)

5. Sidaway v Bethlem Royal Hospital Governors [1985] AC 871

6. See, for instance, Smith v Tunbridge Wells HA [1994] 5 Med LR 334; Pearce v United Bristol Healthcare NHS Trust (1998) 48 BMLR 118;; Chester v Afshar [2004} 4 All ER 587; and, importantly, the GMC’s own guidelines on consent.  See too the discussion in Fovargue S and Miola J, ‘One step forward, two steps back: The GMC, the common law and ‘informed consent” (2010) Journal of Medical Ethics 36(8) 494-7

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11 Responses to Informed consent deserves a little less respect

  • Keith Tayler says:

    Sorry it’s me again – but I could not let this go without commenting.

    You finish with ‘Only Bolam knows what it’s really like out there. It allows decent doctors to be themselves, which is what patients generally want them to be.’ Of course patients want decent doctors but they also want to be protected from incompetent doctors. Surely one of the problems with Bolam is that he should have won his case. Friern Hospital gave Mr Bolam unmodified ECT (no use of muscle relaxant or anaesthetic) which was by then used by the minority of psychiatric hospitals. The Friern Hospital lawyers managed to pay enough expert witnesses (in the black arts of psychiatric quackery) to convince a jury (that had been instructed by Mc Nair J) to bring in a verdict of not liable.

    If only Bolam knows what it’s really like out there, what is stop another Bolam verdict? Indeed, if Bolam rules, what is to stop a competent decent doctor being found negligent because the claimant’s lawyers pay enough expert witnesses to say the doctor’s practice was not in accordance with proper and accepted medical practice?

    Sorry no – Bolam was a low point in medical practice and an even lower point in English law. Thankfully Bolam on its own does not rule and Lord Scarman’s judgment has not been relegated to a box of legal curiosities. Perhaps the best thing to come out of Bolam is that it hastened the end of unmodified ECT in those hospitals that still used it.

    I must confess to a bias. Modified ECT was used extensively in the hospitals I worked in and I knew many patients that had had unmodified ECT. Bolam should have informed about the risks of unmodified ECT. Obviously this could have been problematical but mental health care is difficult.

  • Charles Foster says:

    Keith: many thanks. You’re quite right that Bolam has often been abused. Bolitho v City and Hackney Health Authority, which is cited in the post, was intended to stamp out that abuse. And, by and large, it has. These days lawyers tend to use the expression ‘Bolam test’ as shorthand for ‘Bolam-as-read-through-the-lens-of-Bolitho’. What Bolitho did was to italicise the word ‘responsible’ which had long lain, scandalously unexamined, at the heart of the Bolam test.

    • Keith Tayler says:

      I do not think Bilitho does much to improve the situation. Lord Brown-Wilkinson set the tone by declaring a court would only rarely go against a ‘sound body of expert opinion‘. Without a root and branch reform of how expert witnesses are used in the courts we will continue in the dark shadow of Bolam. Experts witnesses should not give opinions that support their paymasters. I do not support court appointed EWs but I do have a cunning plan to reform the EW system (too cunning to reveal here). We also need to rein in the use of contingency fees, for as the Royal Commission on Legal Service 1979 put it when addressing CFs:

      The fact that the lawyer has a direct personal interest in the outcome of the case may lead to undesirable practices including the construction of evidence, the improper coaching of witnesses, the use of professionally partisan expert witnesses, especially medical witnesses, improper examination and cross-examination, groundless legal arguments, designed to lead the courts into error and competitive touting. (para. 16.4, p.177)

      On the issue of consent, I am reminded of Margaret Brazier’s call for a law and ethics commission to propose reforms to the law through statute. See her ‘Patient autonomy and consent to treatment: the role of the law?’ (Legal Studies, 1987. Vol. 7, Issue 2, 168-193). I also agree with Alasdair Maclean in his resent paper, ’From Sidaway to Pearce and beyond: Is the legal regulation of consent and better following a quarter of a century of judicial scrutiny?’ (Med. Law Review, 2012. 109(1) 40-46), that Margaret’s criticisms are for the most part still apposite.

      So there – I just about put the world to rights before it ends.

  • Anthony Drinkwater says:

    Thank you for your interesting post, Charles, but I’m not quite sure what you are arguing for.
    You seem to use two arguments :
    1, that it is difficult to give understandable, unbiased information to a patient for a host of reasons that you outline, and
    2, that a doctor can manipulate his presentation in such a way to bias the patient’s decision.

    On 1, I agree, but it is also the case that it is difficult for a prospective political election candidate to present his policies without bias, and I guess the situation is similar for a barrister defending his client – but these remarks do not render mistaken the practices or «doctrines» of democratic elections or trials.
    On 2, if you are right, then nothing is changed : the doctor either gives slanted information so that the patient accepts, or (if there is no requirement for informed consent) he does what he thinks to be in the patient’s best interests : ie the same treatment.

    However, I personally prefer the risks of informed consent to paternalism (you’re right of course to state that it’s not infallible, but neither are the alternatives).
    And the doctrine doesn’t prevent doctors being humane, sympathetic or trustworthy : on the contrary, my intuition is that these qualities are more likely to prevail in an atmosphere of informed consent.

  • Charles Foster says:

    Thanks Anthony. I’m arguing that Informed consent is (1) an impossible ideal, (2) potentially a harmful doctrine. in the light of those two facts, it needs to be kept in check. In particular there should be a rapid retreat from the madness of Chester v Afshar. The best way of calling informed consent to heel is by using Bolam in a way that is currently, in the context of consent cases, unfashionable.

  • Charles Foster says:

    Keith: thanks again. In fact Bolitho has changed the legal zeitgeist considerably.
    I agree with a lot of what Margot Brazier says in that famous paper.
    The battle on contingency fees has been lost, I’m afraid. I hate the idea too.

  • Keith Tayler says:

    Damn – I had hoped the world would have ended by now.

    I still have my doubts about Bolitho. As to CFs – the battle may be lost but the war should go on. CFs are nothing more than jumped up maintenance and champerty. The legislation outlawing maintenance and champerty was not repealed until The Criminal Law Act of 1967, there being reasons why, for example, some maintenance should be allowed. But the last forty years has been a succession of lost battles. If previous generations were able to outlaw maintenance and champerty, I think we should make some little effort to at least contain CFs. Given our EW system and CFs, I am not so optimistic about the present zeitgeist.

  • JC says:

    Correct me if I’m wrong Charles (and I’m not particularly experienced in medical law so Its more than likely I am), but you say Scarman’s verdict in Sidaway is on the ascendency but the only case that could possibly support that claim is Chester v Afshar – On that basis that it failed to mention Bolam in its verdict. Smith is commonly believed to have been a prelude to Bolitho and Pearce, it must be emphasised, favoured Lord Bridge’s statement in Sidaway which was a modified Bolam test – certainly not Scarman’s. Ethically there may be a ‘doctrine of informed consent’ but I don’t believe such a doctrine formally exists in UK law at the moment. But I am interested to hear your reply.

  • Charles Foster says:

    JC: thank you. Of the post-Sidaeay cases you cite, Chester is of course the only HL authority, and is certainly authority for the proposition that Scarman’s on the way back. Yes, Pearce expressly endorsed Lord Bridge’s view, but this is what Lord Woolf MR said: ‘In a case where it is being alleged that a plaintiff has been deprived of the opportunity to make a proper decision as to what course of action he or she should take in relation to treatment, it seems to me to be the law….that if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of the doctor to inform the patient of that risk, if the information is needed so that the patient can determine for him or herself as to what course he or she would adopt.’ Some commentators have taken this to mean that the doctrine of informed consent, in the full-blooded US sense, is part of English law. Whether or not that’s true, my assertion about the ascendancy of Scarman is now pretty orthodox. Here, for instance, are Mason and Laurie in the 8th edition of Mason and McCall Smith, para 4.129: ‘….there is no doubt that a movement away from Bolam has developed in the last 10-15 years and that rigid adherence to the Bolam standard in disputes over information disclosure is no longer the approach of the UK courts.’
    In my view the main agent of this change has been Bolam itself, in partnership with the GMC. The GMC has urged the adoption of a standard of counselling in which is embodied something very close to that adopted in strict ‘informed consent’ jurisdictions (I don’t see eye to eye with Fovargue and Miola in their reading of the GMC’s demands). Bolam says: ‘Responsible doctors do what the GMC requires.’ Thus something like informed consent has been imported into medical law on the back of Bolam. One might see that as Bolam putting itself out of a job. Or possibly as just redefining its job description.

    • Keith Tayler says:

      Just some final passing thoughts. Is not one of the main driving forces towards the doctrine of informed consent the BMA’s adoption of Lord Scarman’s dissenting judgement as a ’practice ideal’? Does not the problem of subjective causation , which favours the claimant, mean that the courts may keep Bolam in order to protect the medical profession?

      No need to reply, I think this is getting too complex for a time of merriment and good cheer.

      Also, my apologises to Margot Brazier for calling her Margaret in an earlier post. A combination of over aggressive corrective software and dyslexia means these things happen all too often.

      Happy New Year.

  • Charles Foster says:

    Keith: many thanks. Yes, the BMA’s view is important, but the mechanism by which it becomes important legally as opposed to ethically is, as I argued in an earlier comment, Bolam itself. Bolam has taken some knocks, but will be impossible to knock out. I think it’s slightly too cynical (or perhaps too broad brush) to say that Bolam’s persistence is a consequence of the courts ‘protecting’ the medical profession, but I agree that that’s how it is generally perceived.
    No need to apologise to Margot Brazier: she publishes under the name of Margaret.
    All best wishes.
    C

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