Traditionally, informed consent for clinical research involves the patient reading an approved Participant Information Sheet, considering the information presented and having as much time as they need to discuss the study information with their friends and relatives, their clinical care and the research teams. This system works well in the ‘planned’ or ‘elective’ setting. But what happens if the patient requires urgent treatment for an injury or emergency?. This article reviews the legal framework which governs informed consent in the emergency setting, discusses how the approach taken may vary according to the details of the emergency and the treatment required, and reports on the patients’ view of providing consent following a serious injury. We then provide some practical tips for managing the process of informed consent in the context of injuries and emergencies. Cite this article: Bone Joint J 2017;99-B:147–150

Informed consent is a very important part of surgical treatment. In this paper, we report a number of legal judgements in spinal surgery where there was no criticism of the surgical procedure itself. The fault that was identified was a failure to inform the patient of alternatives to, and material risks of, surgery, or overemphasizing the benefits of surgery. In one case, there was a promise that a specific surgeon was to perform the operation, which did not ensue. All of the faults in these cases were faults purely of the consenting process. In many cases, the surgeon claimed to have explained certain risks to the patient but was unable to provide proof of doing so. We propose a checklist that, if followed, would ensure that the surgeon would take their patients through the relevant matters but also, crucially, would act as strong evidence in any future court proceedings that the appropriate discussions had taken place. Although this article focuses on spinal surgery, the principles and messages are applicable to the whole of orthopaedic surgery. Cite this article: Bone Joint J 2019;101-B:355–360

Aims. Informed patient consent is a legal prerequisite endorsed by multiple regulatory institutions including the Royal College of Surgeons and the General Medical Council. It is also recommended that the provision of written information is available and may take the form of a Patient Information Leaflet (PIL) with multiple PILs available from leading orthopaedic institutions. PILs may empower the patient, improve compliance, and improve the patient experience. The national reading age in the United Kingdom is less than 12 years and therefore PILs should be written at a readability level not exceeding 12 years old. We aim to assess the readability of PILs currently provided by United Kingdom orthopaedic institutions. Patients and Methods. The readability of PILs on 58 common conditions provided by seven leading orthopaedic associations in January 2017, including the British Orthopaedic Association, British Hip Society, and the British Association of Spinal Surgeons, was assessed. All text in each PIL was analyzed using readability scores including the Flesch–Kincaid Grade Level (FKGL) and the Simple Measure of Gobbledygook (SMOG) test. Results. The mean FKGL was 10.4 (6.7 to 17.0), indicating a mean reading age of 15 years. The mean SMOG score was 12.8 (9.7 to 17.9) indicating a mean reading age of 17 years. Conclusion. Orthopaedic-related PILs do not comply with the recommended reading age, with some requiring graduate-level reading ability. Patients do not have access to appropriate orthopaedic-related PILs. Current publicly available PILs require further review to promote patient education and informed consent. Cite this article: Bone Joint J 2018;100-B:1253–9

Our aim in this paper was to investigate the guidelines and laws governing informed consent in the English-speaking world. We noted a recent divergence from medical paternalism within the United Kingdom, highlighted by the Montgomery v Lanarkshire Health Board ruling of 2015. We investigated the situation in the United Kingdom, Australia, New Zealand, Canada, and the United States of America. We read the national guidance regarding obtaining consent for surgical intervention for each country. We used the references from this guidance to identify the laws that helped inform the guidance, and reviewed the court documents for each case. There has been a trend towards a more patient-focused approach in consent in each country. Surgeons should be aware of the guidance and legal cases so that they can inform patients fully, and prevent legal problems if outdated practices are followed. Cite this article: Bone Joint J 2018;100-B:687–92

The purpose of this study was (1) to evaluate the adequacy of informed consent documentation in the trauma setting for distal radius fracture surgery compared with the elective setting for total knee arthroplasty (TKA) at a large public hospital and (2) to explore the relevant guidelines in New Zealand relating to consent documentation. Consecutive adult patients (≥16 years) undergoing operations for distal radius fractures and elective TKA over a 12-month period in a single-centre were retrospectively identified. All medical records were reviewed for the risks and complications recorded. The consent form was analysed using the Flesch Reading Ease Score (FRES) and the Simple Measure of Gobbledygook (SMOG) index readability scores. A total of 133 patients undergoing 134 operations for 135 distal radius fractures and 239 patients undergoing 247 TKA were included. Specific risks of surgery were recorded significantly less frequently for distal radius fractures than TKA (43.3% versus 78.5%, P < 0.001). Significantly fewer risks were recorded in the trauma setting compared to the elective (2.35 ± 2.98 versus 4.95 ± 3.33, P < 0.001). The readability of the consent form was 40.5 using the FRES and 10.9 using the SMOG index, indicating a university undergraduate level of reading. This study has shown poor compliance in documenting risks of surgery during the informed consent process in an acute trauma setting compared to elective arthroplasty. Institutions must prioritise improving documentation of informed consent for orthopaedic trauma patients to ensure a patient-centred approach to healthcare

A recent Supreme Court ruling in the United Kingdom has significantly altered the emphasis of informed consent, moving from a historically ‘doctor-focused’ to a more ‘patient-focused’ approach, in line with the situation in other international jurisdictions. . The reasons for the change are discussed with some recommendations about how our attitudes need to change in the future. Cite this article: Bone Joint J 2015;97-B:1159–61

An informed consent document signed by a patient before surgery is supposed to provide evidence that he effectively received adequate information to be able to give informed consent. In fact, it only provides limited legal protection to the surgeon. Although the situation may vary from one country to another and, within each country, from one court to another, a standard consent form is usually considered inadequate, and a procedure-specific consent form appears as a minimal requirement. Even this will provide limited protection if a patient has presented a complication not listed. When confronted to a determined lawyer who pleads the absence of informed consent, a surgeon will most often not be able to give evidence for disclosure of some specific items to the patient. This raises a number of questions:. - How extensive should the information be? Should compliance with a legal obligation always prevail over common sense?. - How much information can the average patient understand, store up and recall? How make sure that information has transformed into knowledge?. - Is it fair to require a surgeon to decide himself that his patients have been adequately informed, without being suspected to have faced a conflict of interest? Or should an independent authority be responsible for attesting, after an examination interview, that patients have received adequate information and are eligible for surgery?. - Should disclosure of all complications be forced on a patient who does not wish to know about them? Common sense and legal obligations may diverge on this point. - Should preoperative consultations be (video) taped so as to procure objective evidence to serve in case of subsequent litigation?. In litigation cases, the burden of proof used to bear on the patient but has now more or less overtly been transferred to the surgeon, while he is not offered the possibility to face such demands in the current organisation of health care in most countries. Even though paternalistic medicine is no longer politically accepted, many patients still expect counselling rather than just information; law makers and lawyers have decided that these patients are wrong, but it is difficult for physicians who have been trained in the spirit of Hippocrates’ oath to behave merely as informers and technical care providers. Medical activity takes place nowadays under ambiguous conditions. There is a politically accepted vision of medicine in which choices and decisions are made by the patients, as it is supposedly possible to bring all of them to a level of knowledge and understanding which makes this possible; when going in the field, things are different, and most patients are still looking for expert counselling in addition to or in lieu of information. As compared to the situation which prevailed a few decades ago, patients are much less ignorant about medicine in general, but the problem is that medicine has progressed far more rapidly than the layman’s medical knowledge. Besides, a number of studies have shown that retention of information by patients decreases rapidly over time and is fragmentary, with potential benefits from surgery being recalled much better than possible complications. Patients have also been shown to ingenuously deny receiving information despite documented evidence; ingenuous fabrication, i.e. affirmation of an untruth, is also a classical observation. We know all too well that a number of our patients come to surgery without a proper comprehension of their pathology and therapy, and we have to pretend that we are not aware of it, otherwise we would have to deny those patients the benefit of surgery. To change this would require a major involvement not only of the medical profession but also of the almighty health care administrations and of the funds providers

Every surgical act could be considered a criminal offence, were it not for the patient’s consent. The latter formerly used to be considered implicit but it now has to be made explicit, which may include signing an informed consent document. In case of litigation, the surgeon may be required to provide evidence that the patient received full information and was in a position to give informed consent. Every adult individual is supposedly able to understand and to recall technical information on any specific operation; we know how unrealistic this is. The information should be complete, including on complications least likely to occur; it should also be made understandable to the patient. Assuming this would be possible, the surgeon may be requested later on to provide evidence that such information was provided. How to prove this remains an unsolved problem. A stereotyped informed consent document will be no obstacle to a determined lawyer. Unless every patient receives a customised information booklet written with assistance from a lawyer, the surgeon will always have difficulties in providing evidence that the patient was fully informed. Litigation will often end up with patient and surgeon presenting two irreconcilable versions. One of the reasons is poor retention of information by the patient. A number of studies all showed that retention of basic information is poor and falls down to 50 % after one week and 18 % after 6 months; besides, any “unpleasant” information will be selectively forgotten. In countries that do not have a no-fault compensation system, the only way for some patients to obtain compensation for a disability or financial harm following surgery is to sue the surgeon for malpractice. Lawyers have found out that it was easier to plead the absence of informed consent. We have no real possibility to prevent this, and the quest for absolute security would be hopeless and would result in a paranoid behaviour on the part of the surgeons. 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. It is best to treat only patients with whom a confident relationship appears possible, as we know that they will usually not quite understand what is going on and will anyway forget most of the information provided

Abstract. Introduction. The risk of Covid-19 community and hospital acquired infection (HAI) on patient outcomes in trauma is still relevant. Patient's should be routinely consented for this risk to ensure informed consent for perioperative contraction. Method. A prospective audit was completed from December-March 2022 examining a consecutive series of patient admissions with capacity to consent. The standards for compliance was RCOS Toolkit 5#3 stating the importance of enhanced consent for risk of contraction, in operating and changes to care pathways. The target was 95% compliance. 2/2 contingency tables were generated to determine odds ratio for compliance versus Covid+ rate. Results. This audit generated 80 consecutive patients from which 28 were excluded as non-operative or lacking capacity. It was found that 25% (13/52) had been specifically consented for risks of Covid-19. The rate of PCR-positive results was 15% (8/52) with a mortality of 25%. Approximately 2% of patients in this series were informed of the risk and had a positive Covid-PCR. An odds ratio of 0.38 indicates that being informed of the risk is not associated with rate of infection e.g by adopting enhanced personal protective measures. Conclusions. The pandemic recovery has not removed this substantial community and nosocomial risk. Our results demonstrate poor compliance with RCS guidance despite ongoing relevance to care. Consent includes the counselling of a patient to specific Covid-related risks including thrombosis & death. Dissemination of these results will be followed by completion of the audit cycle to look for improvements in compliance

There is a legal and ethical obligation to gain informed consent before treatment commences. A number of bodies have issued guidelines for obtaining consent and these include the Department of Health, the GMC, The Royal College Surgeons of England, and the B.O.A. For a patient to give their informed consent to surgery they must receive sufficient information about their illness, proposed treatment and its prognosis. There are no specific guidelines regarding joint replacement. With this in mind a retrospective case note study was undertaken involving 100 patients who had undergone a hip replacement. Noting the documented discussion at all stages of patient contact.Fifty percent of patients had been seen and listed in the Outpatients by a Consultant, 25% were discussed with the Consultant responsible and the remainder were listed without Consultant input. In only 33 % of cases were any specific risks recorded. This had fallen to 4% on their visit to pre operative assessment clinic. All the consent forms were completed at the time of admission for surgery. Forty percent of these on the day of surgery. The majority were completed by SHOs (58%), while only 4% were completed by consultants. None of the forms noted the lead surgeon. All the consent forms noted some frequently occurring risks. However there was a large variance in the details recorded. The study highlights that the majority of complications are only documented on the consent form, with little note of the dialogue leading up to it. It is also apparent that there is no agreement as to what represents a significant or frequent complication. This review raises a number of important issues. There needs to be a national standardisation of the process of consent. We propose the introduction of a specific consent form for hip replacements that provide improved documentation of the standardised risks involved. This should also include guidelines regarding prosthesis choice, surgical approach and the extent of trainee involvement. In addition we would also suggest there is a need to improve sequential documented discussion up to the point of surgery and introduce specific training for juniors carrying out consent

To explore whether the fundamental concepts of informed consent and patient autonomy are acceptable and practical from a surgeon’s point of view. One hundred and fifty three questionnaires distributed to Orthopaedic Surgeons in NZ were analysed statistically. Seventy six percent of the surgeons guided their patients towards a particular procedure. Fifty five percent spent between 10% and 25% of their consultation time on obtaining informed consent. Forty eight percent of the surgeons felt that the patient did not have sufficient autonomy to choose to undergo a particular procedure, while 76% felt that it was impractical to offer all necessary information needed for that patient to choose the procedure. Although the length of time that a surgeon had been in practice did not influence the practice of obtaining consent or his/her opinion of the patient’s self autonomy, the degree of his/her specialisation did (P< 0.05). There was no correlation between the time spent on obtaining consent and the degree of specialisation. There was a very strong correlation between the surgeon’s belief in patient autonomy, the practicality of offering all the necessary information and the method of obtaining consent (P< 0.0001). The majority of Orthopaedic Surgeons in NZ do not believe it was practical to offer all the necessary information to a patient and to expect that patient to be fully autonomous in choosing to undergo a particular procedure. This indicates that it is time for re-evaluation of the practice of modern day informed consent based on its original concept

The process of obtaining informed consent is an important and complex pursuit, especially within a paediatric setting. Medical governing bodies have stated that the role of the trainee surgeon must be explained to patients and their families during the consent process. Despite this, attitudes and practices of surgeons and their trainees regarding disclosure of the trainee's participation during the consent process has not been reported in the paediatric setting. Nineteen face-to-face interviews were conducted with surgical trainees and staff surgeons at a tertiary level paediatric hospital in Toronto, Canada. These were transcribed and subsequently thematically coded by three reviewers. Five main themes were identified from the interviews. 1) Surgeons do not consistently disclose the role of surgical trainees to parents. 2) Surgical trainees are purposefully vague in disclosing their role during the consent discussion without being misleading. 3) Surgeons and surgical trainees believe parents do not fully understand the specific role of surgical trainees. 4) Graduated responsibility is an important aspect of training surgeons. 5) Surgeons feel a responsibility towards both their patients and their trainees. Surgeons don't explicitly inform patients about the involvement of trainees, believing there is a lack of understanding of the training process. Trainee perspectives reflect this, with the view that families are aware of their participation but likely underestimate their role, and suggest that information is kept purposely vague to reduce anxiety. The majority of surgeons and surgical trainees do not voluntarily disclose the degree of trainee participation in surgery during the informed consent discussion with parents. An open and honest discussion should occur, allowing for parents to make an informed decision regarding their child's care. Further patient education regarding trainees' roles would help develop a more thorough and patient centred informed consent process

Regulations and in force laws impose to obtain an informed consent prior to any care, especially in surgical setting. Such consent must be informed, explicit, personal, specific and aware. Aim of the present study was the drawing of an informed consent form to be used in external fixation. The possible drawbacks of using external fixation have been divided in three main groups: general biological, local biological and external fixation related. Moreover, within this consent, a detailed patient compliance section has been included because of this particular fixation system, with regard on nursing, medications and treatment time. As for the specificity of indications in trauma, the pre-existing of risk factors as cigarette smoking or open fracture has been clearly stressed. Finally, the consent for hardware removal has been predisposed, too

Aim. To investigate the role of websites in enhancing patients' understanding of reason and risk of surgery as a part of informed consent for elective un-instrumented lumbar spine surgery (EULSS). Methodology. This was a National Research Ethical Committee approved RCT study. 63 patients underwent EULSS, out of which 14(29%) declined participation and 14(29%) were excluded. One did not have surgery therefore 34 were randomised to Standard (S) and intervention group (I) using sealed envelope. Standard group were given verbal information & leaflet while the Intervention group were given information on relevant section of . www.eurospine.org. and . www.spinesurgeons.ac.uk. websites. A 13 item Informed Consent Questionnaire (ICQ) was used to collect data. The primary outcomes were patients' perceived understanding of reason and risk of EULSS. Results. Average age was 54 (21–82) years, with similar demographics in both groups. Complete data was available for 20 (13 Standard and 7 Intervention group). No difference (χ. 2. = 0.42, df=1, p= 0.52) was observed on perception of reason and risk of surgery between two groups. Website usage increased from 30% to 50% in intervention group who continued to use the website. Conclusion. Website use appears to be useful to participants. Although support has not been found to accept the experimental hypothesis, valuable information has been gained that will serve to facilitate larger study to further explore the effectiveness of websites in enhancing of EULSS. No Conflict of interest. No funding obtained. This abstract has not been previously published in whole or substantial part nor has it been presented previously at a national meeting

The process of gaining informed consent can be a complex and much debated pursuit, especially within a paediatric setting. The role of the trainee surgeon and its explanation to children and their families prior to an operation has not been explored from the resident surgeons' point of view. Ten face-to-face interviews were conducted with orthopaedic surgery trainees at a tertiary level paediatric hospital in Toronto, Canada. These were transcribed and subsequently thematically coded by 3 reviewers. Three main themes were identified from the interviews. 1) Surgical trainees feel their level of participation and autonomy gradually increases dependent on their observed skills and level of training. 2) Trainees feel the consent process is adequate but acknowledge it is often purposely vague with regards to their intra-operative involvement as this is often unpredictable and it avoids patient/family anxiety. 3) Trainees believe families are aware of their participation however most likely underestimate their role during operations. Trainees in surgical specialties believe their level of autonomy is variable dependent on a number of factors and that this impacts on the ability to be more specific when gaining informed consent. This must be balanced with a family's right to an appropriate understanding of their child's operation and who is performing it. It may be that further patient education regarding trainees and their role in operations would help develop a more thorough and patient centred informed consent process

Objective: To determine whether patient information leaflets improve patient recall during the process of informed consent. Design: Prospective randomised controlled trial which compared a group of patients who were posted a patient information leaflet with those given verbal consent only. Setting: Orthopaedic Unit of a District General Hospital. Patients: 110 patients were selected, of which 57 were randomly allocated to receive patient information leaflets through the post and 53 were given verbal consent only. Outcome Measure: The recall of information given to the patient. This was tested using a questionnaire on admission. Each patient was allocated a score out of ten. Results: There was a significant difference between the group who received patient information leaflets compared to those who did not (P< 0.0001, CI 2.0 to 3.1). Conclusion: Patient information leaflets are a useful tool for the surgeon to improve the recall of the information given to the patient, in order to facilitate informed consent

Objective: To determine whether patient information leaflets improve patient recall during the process of informed consent. Design: Prospective randomised controlled trial which compared a group of patients who were posted a patient information leaflet with those given verbal consent only. Setting: Orthopaedic Unit of a District General Hospital. Patients: 110 patients were selected, of which 57 were randomly allocated to receive patient information leaflets through the post and 53 were given verbal consent only. Outcome Measure: The recall of information given to the patient. This was tested using a questionnaire on admission. Each patient was allocated a score out of ten. Results: There was a significant difference between the group who received patient information leaflets compared to those who did not (P< 0.0001, CI 2.0 to 3.1). Conclusion: Patient information leaflets are a useful tool for the surgeon to improve the recall of the information given to the patient, in order to facilitate informed consent

Study Design: A prospective cohort study of patients undergoing surgery for prolapsed intervertebral disc. Objective: To assess a patient’s ability to recall information discussed pre-operatively at the time of informed consent six weeks following surgery. Subjects: Sixty-one consecutive patients undergoing discectomy for prolapsed intervertebral disc with follow up six weeks after surgery. Outcome measures: Patients were assessed, using a pre-prepared questionnaire, to establish their understanding of disc surgery prior to signing a consent form. All information on the questionnaire had previously been given to the patient at the time of being put on the waiting list via a copy of the clinic letter to the general practitioner. If patients were unable to complete the questionnaire, they were then tutored using visual aids such as posters and models until they were able to answer the questions correctly. The consent form was then signed. Six weeks following surgery, patients were then asked the same questionnaire to establish their ability to recall the information discussed pre-operatively about disc surgery. Results: Prior to tutoring, 20 % of patients were unable to recall that their symptoms were due to disc pathology and that surgery to remove the disc would relieve their symptoms. They were also unable to recall the success rate of surgery. Following surgery, only half of this group of patients could recall these facts. Only 32% of patients were able to recall two or more risk factors of surgery prior to tutoring. This improved to 45% following surgery. Pre- and post-operative questionnaire scores were analysed using a paired t-test. There was no statistical improvement in questionnaire scores long term following tutoring. Conclusion: In this group of patients, extensive tutoring with the use of visual aids as an adjunct, does not statistically improve their ability to recall important information about surgery for prolapsed intervertebral disc and the risks associated with it

Obtaining informed consent for an operation is a fundamental daily interaction between orthopaedic surgeon and patient. It is based on a patient's capacity to understand and retain information about the proposed procedure, the potential consequences of having it and the alternative options available. We used validated tests of memory on 59 patients undergoing lower limb arthroplasty to assess how well they learned and recalled information about their planned procedure. All patients showed an ability to learn new material, however, younger age and higher educational achievement correlated with better performance. These results have serious implications for orthopaedic surgeons discussing planned procedures. They identify groups of patients who may require enhanced methods of communicating the objectives, risks and alternatives to surgery. Further research is necessary to assess interventions to improve communication prior to surgery

Our aim was to determine from the general community an understanding of the implications of informed consent, expectations in regard to self-autonomy, appreciation of risk in surgery, the implications of surgical complications, the degree of acceptability of risk for a given complication and views on surgeon liability. One thousand questionnaires were distributed to members of the general public attending the Palmerston North Hospital as outpatients or visitors (inpatients were excluded). Less than 20% of respondents appreciated the concepts of battery, negligence, self-autonomy and confidentiality. 59% wanted to know about potential complications in order to assist them in making a decision on whether or not to proceed with surgery. Given options and a discussion of the risks, 64% wished to take responsibility for which surgical procedure they would undergo. 9% were unaware that surgical procedures had risks of serious complications. 10% would not undertake surgery if the risk of a serious complication was one in a million, while 30% would undertake surgery regardless of the risk involved. 21% felt the surgeon would be liable in the event of an unmentioned rare complication. The grasp of the perceived objective of informed consent is poor amongst the general population. The tolerance for medical negligence is low and expectations in regard to self-autonomy seem unrealistically high. We feel it is necessary to revisit ‘informed consent’ and for the public (and the legal profession) to make ‘informed consent’ a practical goal-orientated patient/doctor friendly process rather than the existing ‘legal obstacle’ that it is