Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/web/20080616015712im_/http://www.bmj.com/icons/misc/sectionDOWN.gif)
creep before climb
- Jeffrey C McILwain (6 June 2008)
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GMC guidance on patient consent
- Jane O'Brien (6 June 2008)
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Timely proposal
- Penny Mellor (8 June 2008)
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Keep it simple ….. a dummies guide for taking informed consent
- Dhakshina Ganeshan (8 June 2008)
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patient consent
- John Pemberton (8 June 2008)
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Consent takes time – not high tech solutions
- John M Reynard (8 June 2008)
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Not so timely response
- Ed Cooper (9 June 2008)
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GMC guidance on patient consent
- Justine McCulloch (9 June 2008)
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Re: Not so timely response
- Penny Mellor (10 June 2008)
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Who does it?
- Daniel Garros (11 June 2008)
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The patient's agent
- Tom H Hughes-Davies (11 June 2008)
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Informed Consent: Of course, we MUST do better.
- Philip Harrison (11 June 2008)
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Media&Politician; Subservient GMC
- Harold Bourne (11 June 2008)
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Re: creep before climb
- Laura Hair (11 June 2008)
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Jeffrey C McILwain, Consultant, Clinical Risk Management St Helens & Knowsley Teaching Hospitals NHS Trust
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Professor Elwyn’s comment is interesting as an appeal. However, despite the referencing one wonders is this ideal a factual elution or a wish list? I would be interested to find his reference to the statement that “Consent is often completed a few hours before the intended procedure” comes from. Does he mean the re-affirmation, or, the primary consent taking process. In hospital practice the latter may actually be performed at the pre-operative assessment clinic several weeks before the intended procedure, not hours. Whilst the probability of harm, the relative and absolute risk rates are ideal events that should occur, in the real world patients and doctors do not understand, nor use these terms. On a practical nature this is unlikely to achieve “lift off”. Further Professor Elwyn’s idea of “a series of clinicians working to a common goal” suggests more cooks to spoil the broth. Many patients have difficulty relating to the understanding of one person seeking consent let alone being exposed to a legion of variables in quality and skill. There is no mention of providing a Patient Information Sheet that has a copy retained on file to ensure everyone knows the information imparted. Finally there remains the illusion that consent taking is peculiar to hospital practice and involves a written for. As Professor Elwyn works in primary care I would ask him how often a consent form is used for removal of tissue or intimate examination in the primary care setting including forms 2, 3 and 4 from the Department of Health. Further still, how many dentists require a consent form to be completed to Department of Health standards for say a Root Canal procedure? All of the above carry a risk. Yet there remains an embedded view that a consent form is essential, it is not, although the documentation of consent is; that a consent form is a right-of-passage to an operating theatre. Whereas consent, aside from the legal aspects of alleged assault and a transference of authority form patient to clinician is proportionate to the risks involved. In primary care a mole for removal will get minimal consent treatment compared to a mole in a hospital setting with attendant paperwork paraphernalia. The mole is the same, it is the setting (primary vs secondary care) that differs. Further a bunion operation that carries little risk will have a consent form for the procedure and general anaesthetic that must be completed, yet, on a ward a lumbar puncture or chest drain insertion will have no consent form completed, yet have much higher and graver attendant risks. How is this so? Is a consent form really a right-of-passage to have a general anaesthetic and to have the procedure in an operating theatre? Does primary care take consent for the same procedure albeit within a different setting but the same local anaesthetic? Whilst the GMC often draws much criticism, this is a step in the right direction, the matter is whether individual professionals, Royal Colleges and professional associations take up the baton of consent, or not. Academic frustration will remain ripe until consent gets its rightful place ahead of other things. We creep today but tomorrow we may walk before we climb. Competing interests: None declared |
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Jane O'Brien, Head of Standards and Ethics GMC, London
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Professor Glyn Elwyn is right to say that consent must become a ‘pathway’ with clear steps involving patients in decisions from the outset. Consent should no longer be seen as a bureaucratic task. He is also correct in his assertion that the advice in Consent: patients and doctors making decisions together provides ‘broad brushstrokes’ of advice. The guidance is not attempting to address every situation a doctor may face. Rather, it sets out a framework on which good clinical decisions should be based. The GMC has a statutory power to provide guidance to doctors and we do this by describing the high-level principles and values on which good practice is founded. In developing the guidance we engaged widely to find out what key issues doctors, patients, carers and others thought the guidance should address. The medical royal colleges are able to give specialty-specific advice where more details are necessary. We are pleased that Professor Elwyn believes the new guidance signals a ‘cultural change in how informed consent should be achieved’ and welcome any debate amongst the profession and with patients about how clinicians might meet this challenge. Competing interests: None declared |
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Penny Mellor, Campaigner medico/legal researcher Home WV9 5HX
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Is it beyond coincidence that these guidelines are being pushed at the same time as the ongoing GMC hearings about how consent was obtained in a clinical trial (CNEP) [1] or have I just become too cynical about the lack of expediency on the GMC's part to bring the Henshall's case to prosecution? I have a couple of questions to put to those that are interested in the patient's perspective. 1) Is it ethical to ask women who have just delivered a premature baby, who are either still under the influence of anaesthesia or pain relief, to sign a consent form for a clinical trial involving their baby? 2) Does a mother who has just given birth in the circumstances I have just described have the "mental capacity" to absorb, understand and make an informed decision about entering their baby into a clinical trial? For your consideration is the fact that in this country, you cannot sign your will whilst "under the influence", neither can you be interviewed under caution by the police until you are deemed "fit". I would also like to point out that given that opiates (the normal form of pain relief after a C Section) have been shown to enhance suggestibility, that further research needs to be undertaken into this particular aspect of whether or not you can give "informed" consent. [2] [1]http://www.gmcpressoffice.org.uk/apps/news/events/detail.php?key=2610 [2] http://www.erowid.org/psychoactives/law/law_article7.shtml Competing interests: I have a vested interest in how consent is sought from vulnerable patients |
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Dhakshina Ganeshan, Specialist registrar in radiology St Helen and knowsley hospital NHS Trust, Prescot, L35 5DR
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The article ‘’ Patient consent—decision or assumption ‘’is interesting but I wonder what I have learnt new (1) It is amazing to see the amount of attention that the medical consent procedure is receiving. Medicine is at its best when it is simple and that’s how it should be. As a patient, if I am gong to let anyone do any procedure on me, I need to know only these – why do I need it, what are the risks and complications, what alternatives are available and most importantly who is going to do it. The last point is the most important, I don’t care how many doctors speak to me and how many papers I sign, I need these information from the person who is actually going to perform the procedure – from the horse’s mouth. All the other rituals are only medico legal exercises. I suspect this is what the majority of patients would want. Now lets see from a doctor’s perspective. As the registrar or consultant who is going to perform the procedure, I may have got my SHO to speak to the patient and get the consent form signed - but I would definitely speak to the patient in detail and answer whatever questions he or she may have. And of course, I would see the consent form signed by the patient to make sure the details encrypted are right (after all, it is a legal document). This begs the question why ask the SHO to get the consent if I am going to do it anyway. I admit I don’t know the correct answer (if there is any) but if you think about it –it does serve some purposes. The facts are repeated to patient many times, giving him time to think about it and raise questions. This is repeated even more for elective procedure with preoperative clinics. This repetition also helps the junior doctors to learn about what a patient may want to know and serves as a valuable experience in training. I am fairly convinced that this is how things have been going on for a long time. I have read quite a few guidelines on this topic and I am yet to learn anything new. Am I missing anything here? Dhakshina Ganeshan, Specialist registrar in radiology 1 St Helen and Knowsley Hospital NHS Trust, L35 5DR drdakshin@yahoo.co.in Competing interests: None declared Reference: 1. Glyn Elwyn. Patient consent—decision or assumption? BMJ 2008; 336: 1259-1260 Competing interests: None declared |
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John Pemberton, retired iona cannonfields hope valley s32 1ag
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I think that this article is very timely and I hope that it will be acted upon Competing interests: None declared |
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John M Reynard, Consultant Urological Surgeon The Churchill Hospital, Oxford, OX3 7LJ
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I was bemused at a Professor of Primary Care’s perception of the consent process and his suggestions for enhancing it1. He admits the “consent discourse has hardly been studied in depth” so what evidence does he have that the giving of information is often only completed “a few hours before the intended procedure”? What does he think the function of the surgical outpatient consultation is – a one-way exercise in decision making by the surgeon with the patient remaining mute throughout? For many surgeons this is the time when the process of real (adequately informed) consent starts and the discussion is genuinely based around the patient’s concerns and goals. He states that “A signature on a consent form would no longer be sufficient evidence that the patient has been given accurate and tailored information”. A signature never has been, and still isn’t, evidence of consent. The evidence as any QC will tell you is the record (handwritten notes, diagrams, letters to patients, consent information proformas etc) of the discussion held between patient and surgeon. The Professor’s solutions that would require “considerable investment and expertise” are interesting, but unnecessary. A pen, a piece of paper and basic diagrams that need not overstretch the artistic skills of even the average surgeon are important. Simple, structured consent interviews and written consent information sheets enhance understanding and improve recall, in some cases substantially so2,3 and visual prompts (text with still images or videos) can enhance comprehension and retention of information (both during the consent consultation itself and for some time after). This is particularly so in patients with poorer reading skills4,5. None of this requires a high tech solution. The bottom line however, is that the real investment is in time, and as the old saying goes, time is money, which no-one ever parts with willingly! (1) Elwyn G. Patient consent – decision or assumption? BMJ 2008;336:1259- 60 (2) Dawes PJD, O'Keefe L, Adcock S et al. Informed consent: the assessment of two structured interview approaches compared to the current approach. J Laryngol Otol 1992;106:420-4 (3) Langdon IJ, Hardin R, Learmouth ID. Informed consent for total arthroplasty: does a written information sheet improve recall by patients. Ann R Coll Surg Engl 2002;84:404-408 (4) Chan Y, Irish JC, Wood SJ et al. Patient education and informed consent in head and neck surgery. Arch Otolaryngol Head Neck Surg 2002;128:1269- 1274 (5) Rossi M, McClellan R, Chou L, Davis K. Informed consent for ankle fracture surgery. Patient comprehension of verbal and videotaped information. Foot Ankle Int 2004;25:756-62 Competing interests: None declared |
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Ed Cooper, Retired paediatrician London N4
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Why waste anything one has written? Penny Mellor's two questions in her rapid response made me dig out a 1999 file from my computer. It was a letter written to the Lancet in response to its editorial in Volume 353, Number 9154 27 February 1999, on the CNEP trial and the then forthcoming Griffiths enquiry. It was not published. Editor As you say (The perils of paediatric research, February 27), trust in doctors is now under attack and there has been a sea-change in attitudes towards the ethics of clinical research (and to medical glasnost generally) during the decade since the Continuous Negative Extrathoracic Pressure (CNEP) trial was designed and started. However, this does not mean that doctors, who had it pretty good for a long time, must now become so craven that they start to lie down as soon as it looks as if somebody might be about to hit them. You say that the Griffiths inquiry must consider the validity of the conclusion of the Pediatrics paper in the light of the evidence published in the same paper. Why? What business of an inquiry is that? Readers of this accessible, peer-reviewed scientific report can see the data and make up their own minds. More germane, perhaps the only term of reference needed, is the question of the way consent was given at 2 to 4 hours into the neonate’s life. “The inquiry must consider how likely it was that informed consent could be achieved during this difficult time for parents”. I assume this is an open question with no element of rhetoric. If it is not, then it follows that neonatal therapeutic research is already intrinsically unacceptable and other research into emergency treatment as well. An inquiry may come up with helpful suggestions: allowance for cooling-off periods and reversal of decisions, access for relatives to a database, above all updating and review of the clinical situation in partnership between doctors and relatives. However, people in the midst of emergencies have as much right to make their potentially life-and-death decisions on their own family’s behalf as doctors have to make them for them. Who is to say they do not make them just as well, or that they should not share the responsibility for the consequences? Ed Cooper I think that stands up OK today. Competing interests: None declared |
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Justine McCulloch, Consultant Psychiatrist Forth Valley FK8 1RW
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Jane O’Brien comments that, “In developing the guidance we engaged widely to find out what key issues doctors, patients, carers and others thought the guidance should address” was echoed at Wednesday’s Scottish launch. The Glasgow event of the GMC Theatreworks in June last year was at best bemusing. The GMC’s commissioned workshop of a clinical scenario played out by actors while inviting audience participation and discussion, advocated seeking consent for appendicectomy to treat acute appendicitis. I am a psychiatrist and as such I do not treat appendicitis; I thought of a psychiatric analogy and contemplated how I would convince my patient that insulin therapy was the treatment of choice. This seemed a reasonable parallel as most people know leeching is no longer in vogue. Consent, as the GMC advise us, consists of three components: information disclosure; lack of coercion, and the patient having the capacity to make the decision in question. I found I could not complete my self-appointed task of formulating a justification for my proposed insulin/leech therapy; I had no evidence to ground my discussion and no information to disclose. I concluded that my difficulty lay in that I am not particularly prone to flights of fancy within my clinical role, I am pragmatic and I work with my patients to make the right evidence based treatment choices that fit their lives. Most of my colleagues do the same. The ‘consultation’ exercise served to demonstrate how badly the consent process can derail but we were ill served by those at the GMC who failed to highlight this medical inaccuracy to the workshop author. In retrospect, rather than try and participate in the event, the medical answer to, “Doctor, I don’t want an operation....” should have been, “Quite right; I’d report whoever recommended it to the GMC.” Further, Jane O’Brien writes, “Consent should no longer be seen as a bureaucratic task.” In my view, the process of deciding on a line of treatment with which the patient is in agreement is the practice of medicine; however, the documentation of that decision is highly bureaucratic, to say otherwise seems misleading. The guidance itself seems a well constructed update in the area. Competing interests: None declared |
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Penny Mellor, Campaigner/Medico/researcher Home WV9 5HX
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Dr Cooper does not address the specific questions I asked. Men don't have babies, that's a medical fact, men don't know what it's like to give birth, how it feels, what your emotions are like; under normal circumstances there is euphoria mixed in with a deep seated fear that your baby may have something wrong with it. Your first question is "is he/she alright?" Would a mother, having just given birth by caesarean section, knowing her baby is it at great risk due to prematurity, and still under the influence of narcotics, not be at her most vulnerable? I cannot say if I could give "informed" consent, panicked consent, certainly, but not, in my opinion, informed, the fear of my child dying would overwhelm me, just as it used to when I thought they had stopped breathing when they were babies, or went missing for a split second when I was out shopping. I am not talking about routine oerations or life saving treatment for either baby or mother post partum, I am talking about a clinical trial, the unknown and consent being asked at a time when sheer panic has set in. I have discussed the ethics of the CNEP trial at length with criminal barristers and a Queen's Council, it is their legal opnion, that in a criminal setting if a mother, in these circumstances, were to be interviewed by the police and confessed to a crime and signed the confession that this confession would be deemed as being inadmissable due to two factors, one, being under the influence and the second that it would be deemed as coerced. We are talking about somebody giving up their sick baby to a clinical trial, not to have its appendix taken out, we are talking about asking for consent at a point in which the parents of that baby are highly suggestible to anything that they think will give that baby a better chance of living and that's without any effect the drugs may have on mother's capacity, it is a very narrow remit, not to be confused with emergency treatment. Human research is not the same at all. Two of the mothers weren't even adults, they were just 17 years old, one had only just turned 17. Clinical trials require that an appropriate adult is present when informed consent is being asked for, I suppose it just slipped everyone's mind that children were signing off their own children with no appropriate independent adult and that, I am afraid, is not acceptable practice. I, as a mother, want my child's rights protected when I am at my most vulnerable. Is that too much to ask? If you can't sign away your wordly goods in your will under these circumstances, why on earth would it be OK to sign away your child to a clinical trial, the outcome of which was unknown? Competing interests: I gave evidence to the Girffiths Inquiry that Dr Cooper mentions an am a mother to 8 children |
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Daniel Garros, Associate Professor of Pediatrics, Pediatric ICU staff Stollery Children's Hospital, Edmonton AB, Canada T6G 2B7
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One interesting aspect not addressed in the article about obtaining consent is "who" should obtain it? Within the critical care environment (CCU) for example, procedures done by radiologists and surgeons outside the actual unit are a constant. It is not uncommon that the CCU physician is asked, as the patient is leaving the unit, to quickly obtain consent from families. If I am not actually the physician doing the procedure, should I obtain consent for it? Should a nurse, in charge of the radiololgy department that day, obtain consent? Should a doctor in training (resident, fellow, junior registrar) obtain consent in behalf of his supervisor? Informed consent becomes a formality, without real meaning, if the person doing the procedure is not the one obtaining it! Surely this issue is a practical one, and it needs to be properly addressed by hospital administrators. Competing interests: None declared |
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Tom H Hughes-Davies, Retired paediatrician SP6 2EJ
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The patient is asking for help, not submitting to another's decision. We should use request rather than consent forms to make this clear. Competing interests: None declared |
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Philip Harrison, General Practitioner New Zealand
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Professor Elwyn's thesis may create more problems than answers and create dichotomy in the appropriate use of the written word, but informed consent, is a well worn track and an established province of clinical (therapeutic) trials. If we mistrust the pharmaceutical industry so much what is so perfect about our own profession (whom collaborate so closely). So what is so difficult? Surely, communication to patients is more important than our own desired endpoints as clinicians? If we cannot take the patient with us in our medical philosophy, are we fit to be their doctors? And, if documentation is "bureaucratic" then so be it. We are in a progressively accountable world and doctors (and other health care workers) are not in a position to know what is right from knowledge alone. What about the patients belief systems? Is it our place to question them even if we vehemently disagree? No we are THEIR servants, they are not ours. We advise them. They accept or reject. And we record what they understand and accept what limitations this process may have. Limited yes! But better than nothing! And, where the alternative could well be confusion, collusion and unethical behaviour. Yes, we may all mean well but IS THAT ENOUGH? The GMC is scraping the surface of a minefield. Underneath are the skeletons of deceit, misinformation, miscommunication, paternalism, arrogance, incompetence, misguided benevolence and 'professionalism'. Yes, and most of us try to be good doctors. And we all fail. To err is human. Excellence must acknowledge this. Written proof of understanding, even prior to a simple general anaesthetic, for example, allow us busy people to stop and think and say, "what if it was my sister?". What if they do not understand they could die? The publications of Goodyear-Smith *1, following on from Paling*2 and Gigerenzer*3 show we communicate very poorly what evidence supports our intentions. We doctors are also creatures of habit and we need to be more accountable in our own medical belief systems. The GMC have not really done enough but, perhaps, the process has started and I wait with baited breath as it all evolves into our 'Brave New World' which we appear to fear. Philip Harrison
*1 "Patients Prefer Pictures to Numbers to Express Cardiovascular Benefit From Treatment" Goodyear-Smith F; Arroll B, Chan L; Jackson R; Wells S; Kenedy T: Annals of Family Medicine Vol 6, No 3, May/Jun 2008 *2 "Helping Patients Understand Risk" Paling J. BMJ, 2003; 327 (7417): 745-748 *3 "Simple Tools for understanding Risks"; from innumercy to insights. BMJ. 2003; 327 (7417); 741-744 Competing interests: None declared |
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Harold Bourne, Private Practice Rome Italy
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Guidelines betray ignorance of,if not indifference to the psychological needs of seriously ill people.They are usually anxiously dependent,awaiting medical rescue,or even magic,with no appetite for earnest clinical debate.It is realistic to understand this instead of leaning over backwards against paternalism.The GMC,scared of media scandal and of being disempowered by populist politicians,is remarkably lacking in any solidarity with the rest of us out at day and night work in the actual field .. hence these oh so solemn guidelines.. Competing interests: None declared |
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Laura Hair, Salaried GP Pinfold Surgery, Methley, LS26 9AB
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There seems to be an assumption within this article that consent is a less formal process in primary care. Although standards will vary from surgery to surgery, it seems unfair to imply that the process is less vigorous than in the hospital setting. If anything, the patient is much more likely to have consent taken from the person actually performing the procedure, rather than a hospital junior. The setting may be different, but primary care doctors still follow GMC guidance. Competing interests: None declared |
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