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W2100444542 abstract "The Journal of Bone and Joint Surgery. British volumeVol. 88-B, No. 1 Review ArticleFree AccessInformed consent – a contemporary myth?R. LemaireR. LemaireHonorary ProfessorOrthopaedic Department University Hospital, CHU du Sart-Tilman, 4000 Liège, Belgium.Search for more papers by this authorPublished Online:1 Jan 2006https://doi.org/10.1302/0301-620X.88B1.16435AboutSectionsPDF/EPUB ToolsDownload CitationsTrack CitationsPermissionsAdd to Favourites ShareShare onFacebookTwitterLinked InRedditEmail In the absence of consent from the patient, in theory, every surgical procedure could be considered a criminal offence. Until recently, the patient’s consent was considered to have been implicitly granted as long as he or she presented at the appointed date for an elective surgical procedure. This situation no longer prevails and a patient’s consent now has to be explicitly and formally granted. In the event of subsequent litigation, the surgeon may be requested to provide evidence that the patient received thorough information on his or her pathology, on the treatment options, the reason the surgical intervention was decided upon, its potential outcome and possible complications. The surgeon may also be requested to provide evidence that the information was understandable to the patient, while being comprehensive and scientifically accurate, and that the patient was in a position to give informed consent.This requirement is based on the assumption that every adult has the intellectual capacity to comprehend and recall a large amount of technical information which was previously unknown to him or her and which, out of necessity, has been delivered in a short period of time during one or a limited number of consultations.There is no clear cut definition of what constitutes adequate information but it is commonly defined as what a reasonable person in the patient’s situation would need to make an appropriate decision. This is inevitably subjective and, if contested, the decision as to whether a specific patient was in a position to give informed consent may eventually reside with a judge or a jury. They will need to see themselves as potential patients, and accept there may be a limit to their capacity to understand and memorise technical information. Although the legal literature accepts in theory that too much information may be counterproductive, such common sense understanding of patient information may no longer prevail when it comes to judging a specific case, particularly if a patient has suffered a rare complication and the surgeon is unable to prove that adequate warning had been given.Some technical aspects of risk may only become understandable to a layman when they are markedly simplified. All surgeons are aware when they embark on highly-complex explanations, that a number of patients get out of their depth and the only way to re-establish contact is to simplify the issues and stick to the essential points. Different patients have different backgrounds and personalities and to some extent the clinician must tailor the information provided.Nevertheless, the law is clear in its requirement that information provided should extend to all significant complications of surgery, including those least likely to occur, and those related to non-surgical aspects of the treatment (tourniquet, drains, mechanical or pharmacological thromboembolism prophylaxis, antibiotics, analgesic medication, nursing care, rehabilitation, etc). Depending on the local organisation of health care, the type of anaesthesia to be used, and specific information on the risks involved in every type of anaesthesia may or may not be left to the anaesthetist. As pointed out by Lantos,1 if the goal of informed consent is risk-management, consent forms should be encyclopaedic. Unfortunately, few patients can cope with such a volume of information.In litigation cases the surgeon may be requested, sometimes years later, to provide evidence that he complied with his legal obligation, while having to contend with a patient’s lawyer who states the opposite.Denial by a patient that he or she received specific information on important topics may reflect absence of provision of such information, or that they have forgotten that it was provided. Both are difficult to prove. A number of studies have shown that retention of medical information by patients is at best fragmentary, and that it is selective and decreases over time.Studies on information retention by patients have been conducted in various surgical specialties such as general surgery,2,3 abdominal4–6 or thoracic surgery,7 cancer surgery,8,9 urology,10 orthopaedic and trauma surgery,11–22 plastic and maxillofacial surgery,23,24 dermatological surgery,25 neurosurgery,26,27 ophthalmology28–30 and oto-rhino-laryngology31,32 (Table I). Other similar studies have also been conducted in anaesthetics and various fields of internal medicine, including consent to participate in therapeutic trials with simple or double blinding or consent to undergo specific diagnostic investigations. This review does not survey such studies, as they do not refer to the everyday situations encountered by surgeons.The methodology used in studies on information retention has varied, but usually consists of registering the patients’ answers to a questionnaire at a variable interval after the pre-operative information was provided. Questioning took place before surgery in some studies but was post-surgical in the majority, with the time interval ranging from one day to several months. In a few studies, questioning was repeated after several time intervals.2,17,25 The findings are reported as either the proportion of items that were recalled by patients, or the proportion of patients who recalled each specific item. The pre-operative information had been given orally in most instances, usually by the surgeon who was to be in charge of the operation, but in other cases by junior surgical staff or specialised nursing personnel.11 In some studies, written information was also provided using a specific standardised form. Some publications assess the influence of added written material on patients’ recall of information.24,33 In other studies, patients were encouraged to ask for more specific information during a further interview.An informed consent document was signed by the patients upon admission in most instances, mentioning the type of surgery to be performed and its possible major complications. Tape recording of the interview was made in the study by Robinson and Merav.7 In one study, the consultations were taped and given to the patients, so they could listen to them at home.34Analysis of studiesRetention of information by patients is usually poor, irrespective of the way in which it was delivered, the person who delivered it, and the time interval between information and questioning (Table I). This comes as no surprise, as it has also been shown that a patient’s recall of other items such as pre-operative pain and functional status shows poor to moderate agreement with what they had reported pre-operatively.15,35Retention of information is selective and the expected benefits of surgery are recalled much better than the potential risks,17,18 not only in the early post-operative period but also after considerable time has elapsed. This is a consistent feature of all studies that specifically considered this point, which makes it improbable that it could reflect biased patient information. In several studies, patients could not recall any single major risk of their operations despite having been informed of all of them, whereas the possible benefits from the operation were better recalled.The ability to remember information is reduced immediately and continues to decrease with the passage of time. Enquiries made on the same day the information was delivered showed 18% to 81% recall by patients;2,17,28 after one week, 25% to 58% of the information was recalled,2,25,33 after six weeks 40% to 48%2,26 and after six months 10% to 29%.2,7,17 Considering the varying methodologies used in these studies as well as the subjective aspect of the collection of data, it nevertheless appears that there is a deterioration in recall with time.In some studies, a significant proportion of patients failed to recall any of the major items that they were informed about, particularly those related to risks and complications.36 Similar observations have been made in many surgical specialties (Table I).Patient satisfaction with the quality of information provided, was usually high, despite frequent poor recall.9,12,37 Some patients even reported that they had received too much information.38 Some studies reported striking discrepancies between patient satisfaction about information and comprehension by patients of their medical situation. In a retrospective study of 350 consecutive patients who had undergone laparoscopic surgery for acute abdominal pain over the previous 3.5 years, Murphy et al5 found that 91.4% of the patients were happy with the information they had received, although 26.9% did not know or were incorrect about the surgical procedure performed, 20% did not know or were incorrect about the status of their appendix and 30% were incorrect about the diagnosis.Written or pictorial information, when supplemented to oral information, has been found to improve comprehension and retention,13,14,39,40 although no difference was noted in other studies.19,41,42 Some studies have reported that there is an extensive misunderstanding of the risks of surgery by most patients. Fuller, Dudley and Blacktop43 have suggested that pictorial descriptions of the risks should be used in order to improve comprehension.In several studies, a high proportion of patients signed an informed consent form without understanding all or part of it. In the study by Cassileth et al,8 only 40% of the patients had read the form carefully. When they did not understand some items, patients often denied receiving further information and said they trusted their surgeon anyway.10In some studies, patients positively denied having been informed about important specific points, although a tape recording of the consultation showed the opposite. In a study by Robinson and Merav,7 who tape recorded information sessions, 16 of 20 patients positively but wrongly denied that certain major items had been discussed. The next most common error noted in that study was fabrication, i.e. the assertion of an untruth, which was present in 13 of 20 patients. Two patients complained that the pre-operative interviews were too short and not informative, while the recorded portion of their informed consent interview was more than 20 minutes long.Understanding information was found to be directly related to age and education.20,31,44 A lower education level was found in most studies to have a negative influence on comprehension and memory.2,44 Recall of information was also negatively influenced by older age.44,45 Studies on elderly patients have shown that both comprehension and memory performance varied directly with vocabulary level. Repeated comprehension trials improved understanding at all vocabulary levels, but had no effect on memory.45Patients belonging to an ethnic minority may have even more difficulties understanding medical information,46 and the value of a consent form not written in their mother tongue may be questioned. In populations with poor reading skills, the use of animated cartoons has been suggested as a strategy to improve communication.47The quality of patient information may to some extent be related to the communication skills of the person who delivered the information: untrained individuals tend to focus on technical items and to overlook the associated psychological issues.48 Information given by surgical trainees appears to be more often insufficient and/or inappropriate than that given by experienced clinicians.49Although paternalistic medicine is no longer considered politically acceptable, this is nevertheless what many patients expect from their physicians and surgeons. They wish to receive some basic information about their surgery, but they often do not wish to receive more than elementary information about possible complications or failures, once the indication for surgery has been made clear.10,50 A confident patient-doctor relationship clearly remains a key factor in everyday practice, especially in surgery. There are exceptions to this rule, and surgeons are also likely to come across the occasional patient who wants to know everything, and arrives at the consultation with a mass of information of uneven value which he or she has gained from the internet or from non-scientific magazines. In such cases, it may be a painstaking experience to come to a reasonable understanding with the patient and if this appears impossible, it may be wise to avoid treating him or her. Conversely, surgeons are also confronted with the occasional patient who does not wish to hear about possible risks and complications. What is to be done in such cases remains a matter for discussion, and the answer may be different in various countries and societies. Complete risk disclosure has been made a legal obligation in some countries, irrespective of the patients’ personal preference. In other legal environments, the patient has the right to deny risk disclosure, but the surgeon should take a formal record of the patient’s decision, to gain relative protection against legal action at some future time.How far should patient information go? It has been argued that it should also include information on the comparative clinical performance of available surgeons,51 which raises the issue of how objective information on this topic can be procured. Several studies have shown that there is a relationship between surgical volume and outcome, for such operations as total hip or knee replacement.12,52 Patients should, in theory, be made aware of this, even though most may anyway opt for the convenient solution of having surgery in their community hospital.In countries which do not have a no-fault compensation system, the only way for some patients to receive compensation for a disability or financial harm following a complication of surgery is to sue the surgeon for malpractice. Lawyers have frequently pleaded inadequate informed consent, knowing that surgeons will often be unable to provide evidence that they have provided enough information. To the determined lawyer who wants to win the case at any cost, this may appear as a providential opportunity. It is no surprise that, in a study which tried to determine factors influencing the incidence of malpractice claims, the only factor that appeared to be significantly linked to the incidence of such claims was the density of lawyers in the geographical area studied.53 There is no way to avoid this, and the quest for absolute security is hopeless and would result in paranoid behaviour on the part of the surgeons. In litigation cases, a standardised informed consent form will often not be accepted as evidence that the patient was adequately informed. To achieve this would require a much more elaborate document, comparable to a standard insurance contract, with general clauses and others specific to the individual patient, prepared jointly by the surgeon and a specialised legal expert from his institution. Besides being unrealistic, this would take us far away from the traditional patient-doctor relationship in which we have been educated.Some studies have shown that regional variations in rates of surgery for some conditions (e.g lumbar disc surgery) are directly correlated to the number of orthopaedic surgeons per capita.54,55 Keller et al56 studied population-based variations in rates of operations for lumbar disc herniation and spinal stenosis in the state of Maine, USA. They found rates ranging from 38% below to 72% above the average rate, and noted that patients in the highest-rate areas generally had less severe symptoms and signs. They also had inferior outcomes, compared to those in the lowest-rate areas.56 It is somewhat surprising that the indication for surgery itself is rarely questioned in malpractice claims, although this is directly linked to the issue of patient information. Not surprisingly, improved patient information with use of a procedure-specific interactive video disc program was found, in one study, to reduce the rate of surgery for herniated discs without diminishing patient outcomes.57 In a prospective randomised controlled trial comparing outcomes after arthroscopic lavage, arthroscopic debridement and placebo surgery in patients with osteoarthritis of the knee, Moseley et al58 found comparable outcomes in the three groups, which casts some doubt on the relevance of some indications for the first two interventions.A complete disclosure of all the risks associated with a particular procedure to the patient should be viewed as both an ethical and a legal obligation. The surgeon is sometimes asked “what would you do if you were me, doctor”? Ethically surgeons should feel completely comfortable with their advice whilst imagining themselves to be in the patient’s position. The legal position is more complicated. Some legal experts will accept that information has been adequate when deemed sufficient to allow a reasonable person to make an informed decision. Others will assert that the risk of all potential complications must be disclosed and made understandable to the patient.We know all too well that most of our patients come to surgery with only minimal and often inadequate understanding of their pathology and treatment. Most surgeons consider this unsatisfactory, but they accept to work under such conditions because they believe that it cannot be otherwise. Full compliance with the legal obligation for information, as well as securing sufficient evidence for effective medicolegal protection, simply cannot always be achieved.Surgeons are given the responsibility of deciding whether their own patients are in a position to give informed consent. It is possible, but time consuming and costly, to test patients’ knowledge of the consent process. In a study of HIV transmission in Haiti, Fitzgerald et al59 required that participants pass an oral examination on the contents of the consent form, with a passing score of 12 of 15 before enrolment; only three (20%) passed, but the proportion was increased to 80% after improving the information program. Unfortunately there is no indication that improving the pre-operative knowledge of the patients will result in improved recall of information. In their study on patients undergoing total joint replacement, Hutson and Blaha17 gave pre-operative tutoring to their patients who were not consented until they could answer all questions correctly. Despite this, the recall of risks ranged between 2.5% and 25% six months later. Pre-operative testing of patients for understanding of information could be extended to all surgical patients, but would be time-consuming and costly. Moreover, in order to waive any suspicion of a possible conflict of interest, one could also argue that the examination should be given by an independent authority, which would declare the patient informed and therefore eligible for surgery. This may be viewed as science fiction, but it would be more rational than the current system, in which we know that we operate on a number of patients who would not pass such an examination. This would raise further questions. What about those patients who would fail the examination repeatedly? Would they be denied the benefit of surgery or would they have unregulated surgery?The idea that all patients, if properly informed, will become competent to sign a consent form and able to recall the information for a reasonable period of time, is flawed. Improving patient knowledge is both desirable and possible and can be achieved by the use of better communication strategies. But society at large should decide whether it is prepared to provide financial funding for the resources required to produce a perfect system. Besides, we may be wrong in assuming that all patients have the capacity to transform information into knowledge. In the past few years, cognitive psychologists have analysed how people perceive and code risks and then use this information in decision making.60,61 An individual’s decision making is not strictly rational but is subject to systematic biases, because he uses short cuts, called heuristics in the psychologists’ terminology, in order to simplify the decision-making process. These heuristics lead to over-or underestimation of risks. The perception of risk is also affected by a number of factors such as the fact that the risk was known or unknown (the ‘availability heuristic’), its immediacy of effect, and its catastrophic or more subtle presentation. Judgements tend to be anchored on pre-existing convictions. The way in which risks are presented or framed can also affect people’s perceptions of them: a 90% survival rate for total knee replacement after 15 years will be better accepted than the corresponding 10% rate of failure. It is also a common observation that most patients have difficulties understanding the meaning of rates or proportions, added to the fact that they commonly view hazards as more risky for others than for themselves. As we have seen, patients tend to overestimate benefits and underestimate the risks of treatment. This was also noted in a study on cancer patients by Gattellari et al,62 who recorded that, despite proper information about their condition and its prognosis, 80% of patients had unrealistic expectations from the treatment. In their study, regression analyses showed that misunderstanding was predicted by denial, or cognitive avoidance, rather than by factors associated with the communication process. Denial is used unconsciously as an adaptive tool to reduce the emotional impact of unpleasant information. As pointed out by Lloyd,61 it appears that, regardless of how well a risk communication strategy is developed, there may be patient-specific factors which limit its effectiveness.Despite clear-cut affirmation of the opposite by law makers and magistrates, researchers in health care and cognitive psychology accept that it remains unclear whether patients can understand or recall information about the risks of surgery.60 As we have seen, a number of studies have shown that information retention is poor, and the scarce data available on comprehension of information are also not encouraging. Systematic pre-operative testing of a patients’ understanding of their medical situation by an independent authority would probably show this clearly, and this is sufficient reason never to establish such a system of testing. Surgeons must continue only to operate on patients who have given informed consent – a legal prerequisite for their activity – despite being aware that this will turn them into scapegoats if anything goes wrong.Judiciary insecurity has become part of our everyday life and we must cope with it. No-fault compensation systems may improve this, but only to some extent, as financial compensation may not be the only motivation of those patients or relatives who take legal action against a surgeon.63 No-fault compensation systems nevertheless appear as one of the very few solutions available to restore a confident patient-physician relationship. They have proved efficient in the countries where they have been implemented, without resulting in a decrease in the quality of health care.64 It is best only to treat patients with whom a confident relationship appears possible, as we know that they will usually fail to understand completely all the issues and will rapidly forget most of the information provided.Table I. Overview of available data on information recall by surgical patientsAuthor/sSurgical specialtyType info*Time intervalRecall† (%)* O, oral information; W, written information; V, video information† some papers refer to percentage of information recalled, and some papers to the percentage of patients able to recall information; please see individual papers for specific guidelinesLavelle-Jones et al2General surgeryO< 1 day81< 7 days584 to 6 weeks406 months10Askew et al33O2 to 7 days69O, W2 to 7 days97Kriwanek et al4Abdominal surgeryO, W5 days30Leeb et al23Plastic surgery< 7 days35Makdessian et al24Maxillofacial surgeryO2 weeks30O, W2 weeks50Villar and Hume21Orthopaedic surgeryO< 2 weeks40O, W< 2 weeks44Hutson and Blaha171 hour416 months16Savornin et al18< 7 days55Shurnas and Coughlin19OFinal follow-up9O, VFinal follow-up8.5Langdon et al14O18 days38O, W18 days48Saw et al10UrologyPriluck et al29OphthalmologyO2 to 7 days57Morgan and Schwab28O1 day37Hekkenberg et al31Oto-rhino-laryngologic surgeryO1 to 8 weeks48Chan39O9 months29.5O, W9 months50.3Brown et al41O, W20 days29Krupp et al27NeurosurgeryO, V2 hours18Herz et al26O< 2 hours43.5Robinson and Merav7Thoracic surgeryO4 to 6 months29Cassileth et al8Oncologic surgeryW1 day55Lloyd et al60Vascular surgeryFleischmann and Garcia25Dermatological surgeryO, W< 1 day26.51 week24.4References1 Lantos J. 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