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Rapid Responses: Rapid Responses published:
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Updating Australian disclosure requirements
- Malcolm H Parker (26 September 2003)
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Is informed consent only a legal fiction ?
- Giuseppe Vetrugno, Achille M. Luongo, Leonardo Scorcelletti, Massimo Volpe (1 October 2003)
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Re: Is informed consent only a legal fiction ?
- Tom P Marshall (2 October 2003)
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Is informed consent only a legal fiction
- susanne McCabe (2 October 2003)
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Risk Communication: Consent Delayed is Consent Denied
- Mark Hochhauser (20 October 2003)
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Malcolm H Parker, Senior Lecturer, Ethics & Professional Development School of Medicine, University of Queensland, HERSTON 4006 Australia
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In "Influence of the law on risk and informed consent" (BMJ 2003; 327: 731-734), Mazur says that courts in Australia are moving towards a reasonable person standard in relation to disclosing risks of medical interventions. This is misleading. In 1992, the High Court, in the Rogers v Whitaker case, expanded the requirements placed on doctors to disclosing material risks, where such risks were defined as those which, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to, or those which the medical practitioner is aware, or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to. Recent legislation in some Australian states has reframed these requirements in terms of proactive and reactive duties, but the substantive requirements remain essentially as they have been for over a decade. Australia has therefore moved well beyond the reasonable person standard. Competing interests: None declared |
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Giuseppe Vetrugno, Forensic pathologist Policlinico "Agostino Gemelli", Univ. Catt. S. Cuore, Rome 00168, Achille M. Luongo, Leonardo Scorcelletti, Massimo Volpe
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In a BMJ editorial by Berwick and Leape written on July 1999 (1), the authors asked themselves how many people would remain sitting on a plane if the captain would reveal them that the chance of reaching their destination safely is just 97% and the probability of stewardess to make a severe mistake is 6.7%. Luckily, safety statistics in airline travel are far better than the figures previously showed. Those are in fact the figures of accidents in medical performances. Nevertheless, human life is at risk in both cases. No airline ever communicated statistics of adverse events to their passengers and the safety procedures didn’t change in the last two decades (we mean emergency exits, oxygen masks and so on). Why, then, it seems so important to communicate the risk level of a performance instead of another in health care? Do we really think that a patient, who is worried about his sickness and just hopes to recover, could reasonably decide whether a treatment should be performed or it’s really better than another? Isn’t it, on the contrary, that M.D. are simply afraid to be persecuted by legal suits if they don’t tell the patients the whole truth (2) and sometimes even more about risks? Following a written opinion of a appellate judge in California in 1957 (produced just to increase the amount of a damages compensation) M.D. believed that "informed consent" was the solution of an optimised relationship with patients (3). Our opinion is that the term "informed consent" is a myth (4). In fact the same patient could be persuaded by mass media (e.g. by a talk show) that a treatment is absolutely the best way to let him recover from sickness (even if no evidence of risks is referred at that time by talk show). In this and in many other similar situations, it seems very difficult for a patient to have the knowledge to express a really "informed consent". But, let’s suppose that patients are always aware of medical risk. How many cardiac patients would continue to assume ASA just to prevent stroke if they would really mind the advices printed on the notice paper of the drug? How many patients would accept to undergo a surgical treatment for "inguinal hernia" if they would mind risks listed by Burnham (5) to be ironic about this subject (see box below)? None we guess! Is the aim of a medical staff to make patients miss a good treatment because of their fear about communicated risks? In 1990 an Italian surgeon was condemned for chance-medley because he didn’t informed the patient - who died later – about a change of procedure at surgical time (colon resection instead of endoscopic polypectomy). In 2002, for a similar case, a different surgeon was acquitted under the same conditions (pancreatectomy instead of cholecystectomy). The last judge gave the following reason for his decision: "The informed consent that should draw up an alliance between doctor and patient has grown up to become an instrument of legal fights. The target of a professional Doctor is not to train his ability but to save the lives of patients or to improve their life conditions: these are the only decisions to take". It is amazing that even the judges, more than doctors, understand this truth.
Bibliography Competing interests: None declared |
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Tom P Marshall, Harkness Fellow Brigham & Women's Hospital, Boston MA
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A comparison between the airline industry and the medical profession is instructive. And it is indeed striking that informing passengers of their safety record forms no part of their improvement strategy. But how has the airline industry made such dramatic improvements in safety and reductions in errors? There are three important differences between the industry and the medical profession. First the airline industry operates as a system with a common commitment to safety. Second it monitors its performance internally, investigates errors and learns how to change procedures to avoid future errors. Thirdly, having agreed on the necessary changes (whether these mean new equipment, retraining, changing staff roles) it makes sure that they happen. In the medical profession, by contrast, different physicians have different priorities. Performance monitoring has been resisted and when it has happened tends to have been imposed from outside. There is no systematic attempt to learn from performance variations between teams of health professionals. On the rare occasions that lessons are learned, professional bodies are reluctant to insist that necessary changes happen in case this threatens clinical autonomy. Instead, professional bodies have subscribed to a philosophy of inspection and revalidation - which bears an uncertain relationship to improving safety. Competing interests: None declared |
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susanne McCabe, retired home
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Yes for as long as practitioners prefer to get away with it - there is no monitoring of this in practice and mny avoid learning the requisite skills, which includes 'experience and intuition, reflexive practice'. As ever it relies on what people do not know equals the potential to be exploited or denied the right to proper consent. An Open University course 'Professional Judgment and Decision Making' has been discontinued now but this invaluable course may perhaps be found through SESAME for those interested in treating people in less patronising ways than the contributor from Italy.Frankly his phrase 'how many patients would undergo risk..'none we GUESS' is very telling, guesswork is not good practice. The course compilers were very passionate about promoting the use of decison aids but ended up dissillusioned by the reluctance of so many practitioners, not the public, to use them. No practitioner can hold all the information needed to make complex judgements in their head or convey it to people effectively just verbally. Few service users will be aware decision aids but most people are able to handle the concept of risk in their everyday life, it would be useful to learn new tools.- do doctors refuse to take medication because they are aware of the risks? They are often no more competent at judging risk than others yet hardly any will use numerical concepts in the clinic eg one lady described her pain as 'sore' the consultant replied 'well what does that mean'? there are lists of descriptions of pain he could have used; he could have asked how painful on a scale of 1 - 10. He could have used a simple decision tree but what still happens far too often is the doctor decides without reference to the need to give information to people so that they can make decisions - which may include leaving it to a practitioner - whatever the decisions shold be clear and able to be defended. If practitioners still wish to take all the decisons they may find themselves taking all the responsibility too - that is not a good idea in our legalistic culture. Competing interests: None declared |
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Mark Hochhauser, Readability Consultant Golden Valley, MN 55422
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Risk communication is a key part of the informed consent process. But when during that process are the risks communicated? Earlier this year I had my first mid-life colonoscopy at a local medical clinic. Everything went well, but I experienced several risk communication problems due to timing of the informed consent procedure that may create ethical and legal problems for physicians and health care facilities. When does the procedure begin? About two weeks before the colonoscopy, the clinic mailed me information about how to prepare for my colonoscopy, including laxatives, enemas, and fasting. But no informed consent was included, although I suppose that my verbal willingness to go through the preparation and based my understanding of the written risks could be considered "implied" consent. I completed the preparation without going through a formal informed consent process or signing a consent form. What patient rights do I have? Upon arrival at the Clinic, I was given the legally required 10-page, 4,221 words, Minnesota "Patient Bill of Rights" booklet that described my patient rights under Minnesota and federal law. However, based on four readability and writing style software programs (Prose: Readability Analyst, Grammatik 6.0, WStyle Writing Analyst and Correct Grammar) these materials are not well written, making them difficult (if not impossible) for most patients to understand. In terms of readability, while a Flesch Reading Ease Score of about 60 or better (about eighth grade) is recommended, this patient rights document scored 21 (very difficult) at a graduate school reading level. In terms of writing style, although Corporate Voice software suggests about 80% "simple" and "normal" sentences, only 33% of the sentences were so written. While no more than 10% of sentences should be "pompous" and "complicated," 68% were so written. Where a score of 100 = most complex (Grammatik 6.0), sentence complexity = 84 and vocabulary complexity = 62. Finally, although ProScribe software recommends most sentences be written at about an eighth grade reading level, only 8% of the sentences were at grades 8-10, while 55% were written at a graduate school reading level. Even with my PhD, I could not understand it that morning given my somewhat confused state of mind after a preparation day of laxatives, enemas, and no food. Does it make any sense at all to hand out unreadable documents to confused patients and expect them to read and understand them? Health care facilities can say that they’re in compliance with federal and state law because they’re handing out "Patient Bill of Rights" booklets to each patient. But what rights do patients really have if they can’t understand those rights? I signed the consent form when? A nurse took me from the waiting area to the examining room where I changed into a hospital gown, robe and slippers, had my vital signs taken and an IV line inserted into my right hand. I still hadn’t seen an informed consent form. From the examining room, I walked to the room where the colonoscopy would be done, laid down on a table, and talked briefly with my doctor and nurse. I mentioned doing readability research on informed consent forms; my doctor confessed that he was dissatisfied with the consent form and felt that it should be re-written. (How would that conversation sound in a court case?) Finally, I was given the consent form to sign just moments before the procedure began. Even though I’ve written extensively about informed consent, I confess that I didn’t actually read the consent form. I just signed it. I was so tired and physically drained from the colonoscopy preparation that I probably wasn’t even mentally competent to sign a consent form. I don’t know if the consent form contained risk information that was not in preparation sheet I had already read. To be fair, my memory is dimmed a little by the drugs they gave me through the IV line. I do not remember if I signed the consent form before the amnestic was run into the IV line or after the IV was started, although I was later told that the drug was not started until after I signed the consent form. Are questions a substitute for informed consent? A clinic nurse did call me several days before the procedure to ask if I had any questions. I did not, probably because the only information I had about the procedure was the information they had mailed me; I had not yet seen the consent form or talked (or even met) with the doctor. At best, my information about the procedure could be described as "limited." Yet the purpose of informed consent is to give patients the opportunity to make an informed decision about a procedure based on a thorough understanding of the risks and benefits of that procedure. Giving the consent form this late in the process is coercive. Is there any way that I would have refused to sign the consent form after all that I’d been through? Would any patient refuse the colonoscopy, get up off the table, go back to the examining room, change clothes and leave the clinic? When I signed the consent form I had no real opportunity to competently discuss any of the risks and benefits of the procedure within the context of informed consent. I do not know if the consent form contained information that was not included in the materials mailed to me earlier. I signed the consent form because at that moment I just wanted to get the colonoscopy over with. At best, my consent was uninformed consent, or partially informed consent: It was not informed consent. When should patients sign consent forms? Many clinic procedures are probably done this way, where patients are asked to sign a consent form just before the procedure starts. I believe that the colonoscopy procedure actually started when I began the preparation at home the day before. If I had passed out during the potentially risky preparation, wouldn’t that have been part of the procedure? Supposed I passed out, fell, hit my head, and wound up in the Emergency Room, or even died--all with no documented informed consent for the procedure. Is the clinic or doctor responsible for such events? Perhaps clinics and hospitals should send out consent forms (and return envelopes) with the instructions for the procedure so that they have a signed consent before the patient begins the procedure. Even giving patients the consent form when they check into the clinic the day of the procedure is better than waiting to get consent 10 seconds before starting the procedure. If something goes terribly wrong during a colonoscopy and a patient later dies, a malpractice lawyer would probably be able to successfully sue over the way "informed" consent was obtained. Delaying informed consent is a major risk management issue that should be reviewed, lest medical mistakes lead to legal and public relations nightmares for the clinic or hospital. Can physicians defend a delayed consent process such as I’ve described in court and in the media? What would the public relations fallout be if your local or national media reported that patients were asked to sign consent forms just a few seconds before a procedure? Competing interests: Mark Hochhauser is a psychologist in Minnesota who researches, writes, and consults on document readability and writing style. |
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