Aims. The exact risk to patients undergoing surgery who develop COVID-19 is not yet fully known. This study aims to provide the current data to allow adequate consent regarding the risks of post-surgery COVID-19 infection and subsequent COVID-19-related mortality. Methods. All orthopaedic trauma cases at the Wrightington Wigan and Leigh NHS Foundation Trust from ‘lockdown’ (23 March 2020) to date (15 June 2020) were collated and split into three groups. Adult ambulatory trauma surgeries (upper limb trauma, ankle fracture, tibial plateau fracture) and regional-specific referrals (periprosthetic hip fracture) were performed at a stand-alone elective site that accepted COVID-19-negative patients. Neck of femur fractures (NOFF) and all remaining non-NOFF (paediatric trauma, long bone injury) surgeries were performed at an acute site hospital (mixed green/blue site). Patients were swabbed for COVID-19 before surgery on both sites. Age, sex, nature of surgery, American Society of Anaesthesiologists (ASA) grade, associated comorbidity, length of stay, development of post-surgical COVID-19 infection, and post-surgical COVID-19-related deaths were collected. Results. At the elective site, 225 patients underwent orthopaedic trauma surgery; two became COVID-19-positive (0.9%) in the immediate perioperative period, neither of which was fatal. At the acute site, 93 patients underwent non-NOFF trauma surgery, of whom six became COVID-19-positive (6.5%) and three died. A further 84 patients underwent NOFF surgery, seven becoming COVID-19 positive (8.3%) and five died. Conclusion. At the elective site, the rate of COVID-19 infection following orthopaedic trauma surgery was low, at 0.9%. At the acute mixed site (typical district general hospital), for non-NOFF surgery there was a 6.5% incidence of post-surgical COVID-19 infection (seven-fold higher risk) with 50% COVID-19 mortality; for NOFF surgery, there was an 8.3% incidence of post-surgical COVID-19 infection, with 71% COVID-19 mortality. This is likely to have significance when planning a resumption of elective orthopaedic surgery and for consent to the patient. Cite this article: Bone Joint Open 2020;1-9:556–561

Aims. Patient decision aids have previously demonstrated an improvement in the quality of the informed consent process. This study assessed the effectiveness of detailed written patient information, compared to standard verbal consent, in improving postoperative recall in adult orthopaedic trauma patients. Methods. This randomized controlled feasibility trial was conducted at two teaching hospitals within the South Eastern Sydney Local Health District. Adult patients (age ≥ 18 years) pending orthopaedic trauma surgery between March 2021 and September 2021 were recruited and randomized to detailed or standard methods of informed consent using a random sequence concealed in sealed, opaque envelopes. The detailed group received procedure-specific written information in addition to the standard verbal consent. The primary outcome was total recall, using a seven-point interview-administered recall questionnaire at 72 hours postoperatively. Points were awarded if the participant correctly recalled details of potential complications (maximum three points), implants used (maximum three points), and postoperative instructions (maximum one point). Secondary outcomes included the anxiety subscale of the Hospital and Anxiety Depression Scale (HADS-A) and visual analogue scale (VAS) for pain collected at 24 hours preoperatively and 72 hours postoperatively. Additionally, the Patient Satisfaction Questionnaire Short Form (PSQ-18) measured satisfaction at 72 hours postoperatively. Results. A total of 60 patients were randomized, 32 to the standard group and 28 to the detailed group. Patients in the detailed group had significantly higher total recall score compared to the standard group (mean difference 1.29 points (95% confidence interval (CI) 0.51 to 2.08); p = 0.002). There were no differences in HADS-A (mean difference 0.39 (95% CI -2.11 to 2.88); p = 0.757), VAS pain (mean difference 5.71 (95% CI -22.25 to 11.11); p = 0.499), or PSQ-18 (mean difference 0.499; 95% CI -1.6 to 3.42; p = 0.392). Conclusion. Detailed written tools are useful in improving postoperative recall in adult orthopaedic trauma patients. Cite this article: Bone Jt Open 2023;4(2):104–109

Background of study. Following the Montgomery ruling, consent is now a matter of law. The medical professionals have to show proof that risks and implications and material risks are explained to the patient and that they have accepted to go ahead with surgery. Materials and Methods. We devised a free web based programme (. www.consentplus.com. ) which introduces a documented checkpoint to the consent process in hip and knee replacement surgery. It enables reproducible high-quality bite-sized information delivery to patients and their families in an optimal environment. It utilises the flip classroom principle to facilitate dialogue between doctors and patients. It generates physical documentation to show patients’ knowledge and understanding of the risks; to produce a truly informed consent. Results. 1567 users completed the Consent PLUS process over 28 hospitals across the UK. 98.1% of users were satisfied with Consent PLUS in terms of quality of service and information delivered. Users’ self-rated knowledge increased by 29%, independent of age group, prior knowledge or check-point scores. Supportive documentation for 100% of the users, which facilitated the consent process but did not replace the consultation. 60% of users accessed the system via desktop computers, 23% via tablet and 17% via mobile phone. 55 consultant surgeons and 28 hospitals have been registered into the system by the users. 96.9% of users found Consent PLUS useful and 96.3% would recommend it to their friends. 92.6% would use it again. Conclusion. Consent PLUS can facilitate information delivery and improve patients’ understanding of the risks of surgery and its implications subjectively and objectively. Consent PLUS is a tool designed to enhance and facilitate the consent process, not to replace the current consent forms

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

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

Two discrete legal factors enable the surgeon to treat an injured patient the fully informed, autonomous consent of the adult patient with capacity via civil law; and the medical exception to the criminal law. This article discusses current concepts in consent in trauma; and also considers the perhaps less well known medical exception to the Offences against the Person Act 1861, which exempts surgeons from criminal liability as long as they provide ‘proper medical treatment’. Cite this article: Bone Jt Open 2024;5(7):565–569

Introduction: There is paucity in guidance on when and what should be said or who should take the consent for patients undergoing lower limb arthroplasty. Never before, the specialists been contacted for current practice and their recommendations on the content and timing of obtaining the consent in these patients. Materials and Methods: A postal questionnaire was sent to 154 Orthopaedic consultants in the 14 units in NorthWestern region of England. We acquired information on their current practice, awareness of the guidelines and their preferences and recommendations. Results: A total of 117/154 (76%) consultants responded, of which 84 (55%) fulfilled the inclusion criteria. Currently, 36% patients are consented at preoperative assessment clinic and 40% on admission. 75% of the consultant consent themselves or are consented by their registrars. 70% were aware of local or national policies on who should consent patients and 40% on what should be explained and documented. 75% recommended that operating surgeon should obtain consent. The recommended time for the consent was at preoperative assessment by 57%. Discussion: If the act of signing the consent form is to be more meaningful it should be signed by the surgeon who is going to perform the operation. This study demonstrates that the consultants agree on the common complications but have a varied threshold for giving the less common risks. With shortening of the waiting time, there is a growing body of surgeons suggesting that the consent should be done at the listing itself

Introduction. The case of Montgomery in 2015 considered standards of risk disclosure, whether alternative treatments had been discussed, standards of professional performance, and the importance of patient autonomy. Methods. A survey was devised to investigate orthopaedic surgeons' knowledge of the law of consent and risk disclosure and distributed by Survey Monkey. Results. 194 respondents from a total of 365 consultant orthopaedic surgeons contacted (53%). 85% of respondents were aware that Montgomery is primarily an obstetric case, 14.5% thought it was a spinal surgery case, and 1 respondent (0.5%) thought it was a paediatric surgery case. 99% correctly defined the Bolam test, but 57% erroneously believed that Bolam was still applicable in consent cases. 7% of respondents believed that it was not necessary to disclose a risk of surgery if the risk was less than 1%, and 4% of respondents if the risk was less than 10%. The legal test of materiality was correctly identified by 86% of respondents where a reasonable person in the patient's position would be likely to attach significance to the risk. 5% erroneously believed that provision of a standardised, printed information booklet provides sufficient risk disclosure for the individual patient to give their informed consent. 97% were aware that the surgeon must discuss reasonable alternative treatments including ‘no treatment’. Only 28% were aware that when a surgeon refers a patient for an interventional radiology procedure, it is the referring doctor who should formally hold and document the initial consent discussion. Discussion. General awareness of Montgomery was satisfactory, including the need to discuss alternative treatments including ‘no treatment’, and the qualitative concept of material risk. There was less understanding that material risk is independent of any quantitative rate of occurrence. Over half of consultants erroneously believed that the Bolam test was still applicable in consent cases. Small numbers of respondents erroneously thought that an information booklet constituted sufficient information disclosure. There was widespread misunderstanding that if a consultant surgeon refers an individual for an interventional radiology investigation it is in fact for the referring doctor to hold the initial consent discussion. Further training is required in respect of several issues raised by Montgomery

Introduction. Appropriate consenting is part of good medical practice and is a medico-legal necessity for invasive procedures. The BOA recently created generic consent forms covering the relevant complications for orthopaedic procedures, thus providing a standard for all orthopaedic consent. This study aims to assess the quality of consent in orthopaedic practice. Materials/Methods. The most common elective and trauma procedures were identified over a one year period and consent forms for all patients undergoing these procedures were assessed against BOA ortho-consent forms. Data was compiled from elective total hip replacements (THR) and trauma ankle open reduction and internal fixations (ORIF), and analysed in excel. Results. Forty ORIF's and forty-one THR's were considered totalling eighty-one cases. The average percentage of total complications included per form was 50%. Consultants had a higher average percentage of documented complications to all other grades (56%)(graph 1). Elective cases had a higher percentage of total complications included (59%) than trauma cases (40%). All consent forms included the risk of infection. Only 2.5% of THR consent forms included the risk of death and none of the ORIF consent forms included the risk of numbness post-op. All other complications were variably included (graphs 2 and 3). The most common grade to fill in consent forms were SHO's making up 60% of the forms (Chart 1). Conclusion. Consent forms are not being filled in appropriately. This is a medico-legal risk we should be aware of and we would recommend the use or provision of ortho-consent forms as routine practice

The purpose of this study is to evaluate prospectively the comprehension of a specific, detailed and fully informative consent in a standardized manner using a validated tool. The Deaconess Informed Consent Comprehension Test, a set of standardized questions related to eight domains of informed consent was used to survey nearly one hundred patients in a randomized controlled trial (RCT) over a year. The results of our survey demonstrate the lack of comprehension of respondents regarding most of the domains of “informed” consent. This study highlights the limitations of informed consent and the need of alternative concepts, such as entrustment/valid consent. The purpose of this study was to evaluate prospectively the comprehension of a specific, detailed and fully informative consent in a standardized manner using a validated tool. The results of our survey clearly demonstrate the lack of comprehension of the respondents regarding most of the domains of the “informed” consent. We are therefore concerned about the moral value of such consent. This study highlights the importance of discussing the limitations of informed consent and the need of alternative concepts, such as entrustment and valid consent. We surveyed nearly one hundred patients enrolled in a randomized controlled trial (RCT) over a year. All received their own copy of a specific, detailed, fully informative explanatory letter, the consent form and a patient’s guide to medical research. The Deaconess Informed Consent Comprehension Test, a set of standardized questions related to eight domains of informed consent, was used to evaluate the comprehension of research participants. Although over half of the research participants had retained a copy of the explanatory letter, the consent form and the guide, nearly 40% did not understand the purpose of the RCT. An overwhelming majority (greater than 90%) failed to identify the risks/discomforts associated with the study, while almost 60% of respondents could not identify potential benefits of their participation in the RCT. A mere 56% could provide a clear explanation of randomization. However, over 75% could identify the appropriate persons/process in case they had queries or concerns about the study

Abstract. Background. Whilst the literature abounds with patient reported outcomes following total knee replacement (TKR) there is a paucity of literature covering objective functional outcomes. Awareness of objective functional outcomes following TKR is key to the consent process and relating it to pre-operative function enables a tailored approach to consent. Objectives. Identify trends in a range of functional outcomes prior to and following TKR up to one year post-operatively. Methods. We prospectively gathered data from 82 patients undergoing TKR, examining over 20 functional measures preoperatively and postoperatively at 6 weeks, 3, 6 and 12 months. Our functional lab incorporated validated assessments and assessments selected by surgeons & physiotherapists seen to be critical to outcomes following TKR, such as: kneeling ability, 6 minute walking distance, time to ascend/descend stairs, quadricep moment strength, single stance difficulty, ability to walk on an uneven surface, “Time to get up and go”, upslope/downslope speed. Results. Our results demonstrated that if a patient was able to kneel preoperatively they had an 82.5% chance of being able to kneel postoperatively; if they could not kneel preoperatively this dropped to only 50% but overall over two-thirds of patients were able to kneel at 1 year postoperatively. Other selected results include: 49% increase in 6-minute walking distance, 45% reduction in time to ascend then descend stairs, over 50% increase in quadriceps moment strength, over 40% increase in both upslope/downslope speed and over 70% reduction in difficulty walking on an uneven surface. Conclusions. With these results we can not only discuss specific functional outcomes following TKR but also relate these to preoperative functional level, enabling a more tailored, detailed and robust consent process. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

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

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

Introduction. Guidelines from the North American Spine Society (2009 and 2013) are the best evidence-based instructions on venous thromboembolism (VTE) and antibiotic prophylaxis in spinal surgery. NICE guidelines exist for VTE prophylaxis but do not specifically address spinal surgery. In addition, the ruling of the UK Supreme Court in 2015 resulted in new guidance on consent being published by the Royal College of Surgeons of England (RCSEng). This study assesses our compliance in antibiotic, VTE prophylaxis and consent in spinal surgery against both US and UK standards. Methods. Retrospective review of spinal operations performed between August and December 2016. Case notes, consent forms and operation notes were analysed for consent, peri-operative antibiotic prescribing and post-operative VTE instructions. Results. Four Spinal surgeons performed 45 operations during this period. 31 patients (69%) received a copy of the signed consent with this process being formally documented in 22 (71%) of those cases. All patients were consented by a competent surgeon. 82% of cases consented prior to the date of procedure were countersigned on the day of operation. There was a mean time of 25.3 days between initial consent and operation (Range: 0–170). 37 (82%) cases had clear instructions for VTE and antibiotic prophylaxis. All prescribed post-operative antibiotics were administered. Discussion. The North American Guidelines state that prophylactic antibiotic is appropriate in all spinal surgery with prolonged cases requiring intraoperative re-dosing and only complex cases needing a postoperative regimen. Eight patients underwent a complex procedure and 7 appropriately received postoperative antibiotics. Of the 29 patients that underwent a simple procedure, 12 did not receive post-operative regimen, in line with the guidelines. However, the remainder 17 were over treated. The US Guidelines recommend mechanical VTE prophylaxis only in elective spinal surgery except in high risk patients. All our patients received VTE mechanical prophylaxis. RCSEng guidelines require consent being taken prior to procedure by a competent surgeon and confirmed on day of procedure. All patients in our cohort were consented prior to the date of operation allowing time for considering options and independent research. 82% of patients had consent confirmed on day of operation. Conclusion. This study demonstrates that we met guideline advice for all patients with regards VTE prophylaxis. We have a tendency to over treat with post-operative antibiotics and not all patients had their consent confirmed on day of procedure but was consented well before day of operation. North America still lead the way with guidelines on spinal surgery to which we should adhere, with NICE guidelines providing limited instructions. New consenting guidelines from RCSEng may not be currently widely known and thus should be a source of education for all surgeons

Purpose: The aim of this survey was to assess the practice of obtaining informed consent for Total Knee Replacement Surgery in the United Kingdom. Method: A postal questionnaire was distributed to consultant members of the British Orthopaedic Association. They were questioned regarding their practice for obtaining informed consent for Total Knee Replacement Surgery. Results: Of the 1571 consultant members contacted 34% (526) replied. From these 76% (400) performed total knee replacements. Informed consent was obtained in a pre-operative assessment clinic in 64%, on admission in 32.5% and during the first clinic visit in 3.5% of cases. Consent was routinely obtained by Consultants in 76%, Senior House Officers in 38%, Pre-Registration House Officers in 4% and Specialist Nurses in 5% of cases. Consultants warned of the following complications: Infection 99.2%, Stiffness 70.5%, Aseptic loosening 81.6%, neurovascular damage 56.9%, DVT 96.5%, PE 88.5%, Wear 61.2% and Mortality 67.4%. Patient information leaflets were provided by 71.5% of consultants for Total Knee Replacement. Conclusions: This survey has identified inconsistencies in the complications described to patients. Junior practitioners are continuing to obtain informed consent. Informed consent should be obtained by a suitably experienced practitioner. Patient information leaflets should be provided to patients at the time of listing. We recommend national guidelines relating to obtaining consent for Total Knee Replacement should be published by the BASK. These could be incorporated into their best practice document regarding Total Knee Replacement Surgery

Introduction: The aim of this study was to assess the practice of obtaining informed consent for Total Hip Replacement Surgery in the United Kingdom. Methods and results: 1571 consultant members of the BOA were surveyed by postal questionnaire regarding their practice towards obtaining informed consent for total hip replacement surgery. 524 (33.3%) replies were received. 368 (23.4%) of the 524 consultants who replied still performed total hip replacement surgery. In obtaining informed consent for hip replacement surgery consultants warned of the following complications: Infection 99.7%, Dislocation 98.9%, Leg length discrepancy 75.2%, Aseptic loosening 85.8%, neurovascular damage 61.9%, Wear 63.2%, DVT 96.0%, PE 89.0% and Mortality 71.6%. Consent was routinely obtained by Senior House Officers in 38.7%, by Pre-Registration House Officer in 3.8% and by specialist nurses in 5.4% of cases. Patient information leaflets were provided by 72.0% of consultants for Hip Replacement. Discussion: We recommend national guidelines relating to obtaining consent for hip replacement should be published by the British Hip Society. This should be incorporated into their best practice documents regarding Hip replacement Surgery. Consent should also be obtained by a suitably experienced practitioner

We hypothesise that patients are unable to recall much of the information imparted during the informed consent procedure. This may have important medico-legal consequences and increase patient anxiety. Receiving the information in a written format may improve patient recall. There have been no previous studies testing recall or information sheets for British orthopaedic patients. We performed a randomised controlled trial of consent for total hip arthroplasty, with one group of patients receiving a written information sheet with explanation as necessary, and the control group receiving the same information verbally. The consent was obtained at a pre-operative assessment clinic approximately three weeks before admission. On admission, a questionnaire was filled in both groups of patients to assess recall. There were no significant differences between the two groups with regard to type of arthroplasty (revision or primary), age, or days from consent to admission. The group receiving written information performed better in the recall questionnaire. This group were pleased to have received the information sheet, there were no negative comments about the sheet. In the group who received verbal information, most expressed a desire to receive a written information sheet. One patient stated that she would rather know nothing about the operation and would have refused a sheet. We conclude that patient information sheets are an acceptable and appropriate method of imparting the necessary information for informed consent for total hip arthroplasty, and are more effective than standard verbal informed consent. Medico-legally, the sheet could be a permanent record of what was discussed. This should prevent disputes and claims due to poor recall of the consent procedure

Introduction: Spinal surgical procedures are associated with significant morbidity. It is vital the patients are aware of the potential complications and the implications. The General Medical Council published guidelines regarding consent in June 2008. Aim: To examine the adequacy for consenting for spinal surgical procedures and focussing on documentation of serious risks. Methods: Case notes of seventy consecutive patients who had undergone spinal surgery were retrospectively reviewed. The consent forms were examined for documented procedures, complications, grade of the consenting member and timing of the consent. Results: The documented procedure on the consent form and the operation sheet matched in all seventy cases (100%). Consent was taken by the consultant in 50% of the patients, 30% were consented by middle grade doctors and 20% were consented by the junior doctor. The consenting person was present at the procedure in 63% of the cases. Sixty percent (60%) of the patients were consented in the pre-admission clinic, 23% were consented on the day before the procedure and 17% were consented on the day of the procedure. Common and serious complications such as infection (84%), bleeding (76%), pain (67%), bladder and bowel problems (84%), paralysis (70%) and nerve root damage (67%) were clearly documented. Conclusion: Two-thirds of the patients are given adequate information to obtain informed consent in the pre-admission clinic. Majority of the patients are aware of the common and the serious risks associated prior to the procedure. Interests: None. Ethics approval: None

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

One of the ethical and legal requirements of valid consent for treatment is that patients must be fully informed about the complications involved. The General Medical Council (UK) insists that all adverse outcomes of a treatment, which are serious or frequently occurring, must be discussed with the patient. Previous studies have found a large variance in the risks documented on consent forms for orthopaedic hip operations. The aim of this study was to compare the risks documented for three orthopaedic hip operations against pre-constructed operation-specific consent forms endorsed by the British Orthopaedic Association. We retrospectively analysed 300 consent forms for total hip replacements, hip hemiarthoplasties and dynamic hip screw operations (n=100 for each) and noted the risks documented, whether the form was completely legible, the grade of the Doctor obtaining consent and whether a copy of the consent form was given to the patient. We found that of the 300 operations, only 43.1% of the complications were documented as recommended by the British Orthopaedic Association. Furthermore, 26.3 % of consent forms were illegible, 72.7% of patients were consented by the Senior House Officer and only 13.7% of patients were offered a copy of the consent form. Our results indicate that the Methods: of obtaining consent and filling in the consent forms for orthopaedic hip operations could be vastly improved. One method which could be utilized to achieve this would be the incorporation of procedure specific templates in the consenting process. These templates are already in the public domain and free to use at . www.orthoconsent.com. This would allow the patient to weigh up the risks and make a valid informed decision about their treatment and also protect the Doctors from any possible litigation