Surgical Consent Research Articles

Parental Refusal of Consent for their Child's Medical Treatment: An Ethical, Professional and Legal Dilemma

AbstractParental refusal to consent for medical and surgical consent can present children's nurses with a professional dilemma and can potentially negatively impact the care provided for the both the paediatric patient and their family. With in this article, the legal, ethical and professional aspects associated with this dilemma are presented and discussed from the parental, child and nurse point of view.

Metastatic Lesions to the Liver

Welcome to this issue of International Journal of Hepatology. The focus will be on metastatic lesions to the liver. We are hopeful that this topic will be of interest to hepatobiliary surgeons, surgical oncologists, medical oncologists, and CT, MR, and interventional radiologists. Liang et al. review hepatic arterial infusion for liver lesions. This therapeutic modality has been propounded since the 1990s by Margaret and Nancy Kemeny, a surgical and medical oncologist, respectively. Liang et al. relate that hepatic arterial infusion may provide good locoregional control of liver tumors. It may be particularly beneficial for colorectal tumors in combination with systemic chemotherapy. Exciting new medications infused through the device may one day lead to stunning advances in this field. Kelly et al. review hepatobiliary contrast-enhanced magnetic resonance imaging for liver metastasis from colorectal cancer. They provide a succinct summary of this topic which should improve the surgeon's ability to plan the appropriate surgical approach and consent patients correctly. Kele et al. revealed a lack of anatomical concordance between preablation and postablation CT images, which may be a risk factor related to ablation site recurrence. This is very important since accurate ablation of metastatic lesions remains the cornerstone of excellent long-term outcomes. Additionally, early detection of recurrence and risk factors for said recurrence are necessary in order to initiate timely retreatment. Bacchetti et al. review, via a meta-analysis,surgical treatment and survival for metastatic neuroendocrine tumors. They found a significantly longer survival in patients treated surgically compared to those treated with embolization. This meta-analysis is another example of advances made in this field including transplantation and new medications. Nguyen-Khac et al. review hepatotoxicity (particularly sinusoidal dilatation) associated with chemotherapy. This is particularly important since many patients receive many courses of chemotherapy before and after surgical intervention. Hopefully, with the advent of new medications, these side effects will be attenuated. We believe this issue is just the beginning in a long line of special issues which will lead to greater understanding of complex hepatologic issues and improved outcomes for our patients.

Standard Operating Procedures for Peyronie's Disease

Peyronie's disease (PD) refers to a penile deformity that is associated with sexual dysfunction. To provide recommendations and Standard Operating Procedures (SOPs) based on best evidence for diagnosis and treatment of PD. Medical literature was reviewed and combined with expert opinion of the authors. Recommendations and SOPs based on grading of evidence-based medical literature. PD is a fibrotic wound-healing disorder involving the tunica albuginea of the corpora cavernosa. The resulting scar is responsible for a variety of deformities, including curvature, shortening, narrowing with hinge effect, and is frequently associated in the early phase with pain. Patients frequently experience diminished quality erections. All of these conditions can compromise sexual function for the affected male. The etiopathophysiology of PD has yet to be clarified and as a result, effective, reliable, mechanistic directed non-surgical therapy is lacking. The management of PD consists of proper diagnosis and treatment, ranging from non-surgical to surgical interventions. The main state of treatment for PD rests at this time on surgical correction that should be based on clear indications, involve surgical consent, and follow a surgical algorithm that includes tunica plication, plaque incision/partial excision and grafting, and penile prosthesis implantation.

Preceding the procedure: Medical devices and shared decision making

Carl Thomas is a man in his early fifties with osteoarthritis of the hip. He and his orthopedic surgeon, Dr. Jones, discuss various treatment options and ultimately decide on total hip replacement (THR). Dr. Jones reviews the procedure with him and confirms that he understands his options. Then Mr. Thomas signs the surgical consent form. This discussion appears to include all the elements of informed consent, but several ethical questions linger beneath the surface. Dr. Jones discussed the risks and benefits of total hip replacement in some detail to help Mr. Thomas decide whether or not to have surgery, but should Mr. Thomas also have participated in the decision about the specific implant to be used? This article teases out the ethical issues underlying the choice of a medical device for surgical procedures, using the example of total joint arthroplasty to illustrate the interactions between surgeons and their patients. We highlight shortcomings in the current regulatory process that result in a thin evidence base on which to anchor these technical decisions, and we note the potential for decisions to be influenced by the surgeon’s personal beliefs and possible conflicts of interest. We suggest that the informed consent process could be enriched with a greater focus on shared decision-making. This would include discussing the choice of implant and other technical decisions that may affect the outcome of the procedure, in addition to disclosing any relevant financial relationships. We note the challenge of providing patients with easily digestible information that helps them make decisions consistent with their own values. The Table highlights the most salient aspects of the conversations that we suggest occur between surgeons and their patients. We focus our discussion around the example of total joint replacement, but these issues are generalizable to decisions about non-orthopedic devices such as cardiac pacemakers, stents, and implantable defibrillators, as well as innovative, technically complex, and potentially risky non-surgical therapies like biologic agents for rheumatic conditions.

Clinical Issues—December 2012

This MonthInformed consent for repeated proceduresKey words: informed consent, sequential procedures, serial procedures, repeat procedures, power of attorney.Obtaining informed consent after administration of preoperative sedationKey words: informed consent, surgical consent, preoperative sedation.Use of medical scribes in perioperative servicesKey words: medical scribes, clinical information managers, health care worker.

Informed Consent for Sacrocolpopexy

The purpose of the informed consent process is to reinforce a patient's understanding of her condition and treatment alternatives and to thoroughly review the chosen procedure with its risks and benefits. We aimed to evaluate how well women who consented to undergo sacrocolpopexy understood their planned procedure. We prospectively studied women who had undergone detailed informed consent in preparation for laparoscopic or robotic sacrocolpopexy. A 15-item questionnaire was developed and administered before surgery to assess the patients' comprehension of preoperative counseling. Fifty women were enrolled. The mean knowledge score was 69.7%. Sixty-four percent of the patients did not recall that they could have a prolapse repair without mesh, 44% did not understand the location of mesh attachment, and 34% believed there was no risk of recurrent prolapse. Women who completed the questionnaire within 3 weeks of signing the surgical consent had a higher mean score (78.5%) than women for whom 3 or more weeks elapsed (66.3%; P=0.02). Despite detailed preoperative discussion, women had deficiencies in their understanding of sacrocolpopexy. New methods to improve patient education and comprehension should be considered.

The numeric threshold for the disclosure of risk: outdated and inapplicable to surgical consent

The numeric threshold for the disclosure of risk: outdated and inapplicable to surgical consent

Soft tissue morphology of the naso-maxillary complex following surgical correction of maxillary hypoplasia

Orthognathic surgery is undergone to improve facial and dental aesthetics and to improve function. Three dimensional (3D) soft tissue analysis based on stereophotogrammetry provides a realistic measurement of facial morphology. There is a need for objective assessment of surgery outcomes. The study aim was to evaluate the 3D naso-maxillary complex soft tissue morphology following Le Fort I maxillary advancement and compare the findings with a local reference group. 3D images of 112 volunteers were captured using stereophotogrammetry and viewed by 8 lay people; 40 images (16 males and 24 females) were chosen as the reference group to have harmonious facial appearance. The linear and angular measurements of this group were compared with 35 patients (19 female and 16 male) who had maxillary advancement in the post-surgical group. Facial morphology post-surgery was similar to the reference group, except the nasal base width which was wider by 2.3mm in males and 2.6mm in females. In the orthognathic group, the females had a smaller nasolabial angle by 9.7° than the reference group. In conclusion, 3D imaging is a sensitive tool for analysing facial appearance. Compared with a control group, statistical differences were identified in soft tissue morphology which should be considered in surgical planning and patient consent.

Informed surgical consent for a mesh/graft-augmented vaginal repair of pelvic organ prolapse

Complex issues surround informed surgical consent for pelvic reconstructive surgery. Vaginally placed mesh/grafts are used with the intent to increase durability of the repair but potentially introduce unique complications, offering new challenges in informed surgical consent counseling. Informed consent is a process that takes place throughout the entire consultation with the patient. A written document often accompanies that process. This paper outlines necessary components of informed surgical consent and the theory behind each component. We explore elements that should be included in the consent process with regard to expected benefits, alternatives, and material risks that are specific to the use of a mesh/graft-augmented vaginal repair of prolapse. Included is an appendix that may serve as a template for the creation of a surgeon's own written informed consent document.

The numeric threshold for the disclosure of risk: outdated and inapplicable to surgical consent.

When describing the risks of surgery to a patient, there is a common and mistaken supposition by surgeons that there exists a numeric threshold of improbability beyond which there is no need to disclose. Where should the line be drawn?

The changing face of informed surgical consent

To determine whether procedure-specific brochures improve patients' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed 'Request for Treatment' consenting process is viable on a large scale. A prospective, questionnaire-based study of 100 patients admitted for selected, elective surgical procedures. In total, 99 per cent of patients were satisfied with the information received in the out-patient department, regarding the proposed procedure. However, 38 per cent were unable to correctly state the nature of the surgery or specific procedure they were scheduled to undergo. Although the vast majority of patients were able to state the intended benefits to be gained from the procedure, only 54 per cent were able to list at least one potential complication, and 80 per cent indicated that they wished to be informed about all potential complications, even if these occurred in less than 1 per cent of cases. The introduction of procedure-specific brochures improved patients' pre-operative knowledge. Although the failings of current consenting practice are clear, the Request for Treatment consenting process would not appear to be a viable alternative because of the large number of patients unable to accurately recall the nature of the proposed surgery or potential complications, following consent counselling.

Prospective Evaluation of Patient Comprehension of Informed Consent

Physicians and society may overestimate the level of patient comprehension during the process of obtaining informed consent for medical and surgical treatment. The purpose of this study was to prospectively measure the immediate level of patient comprehension at the time that surgical consent is obtained and the effect of time on this level of understanding. In addition, we studied the effect of sex, education level, and age on comprehension. One hundred patients scheduled for elective orthopaedic surgery were enrolled voluntarily into this study. Following discussion of risks and benefits with the surgeon and a reading and explanation of the entire consent form, each patient immediately completed a questionnaire to test recall of the information that had just been reviewed. The same questionnaire was administered to each patient at the first postoperative visit and, if applicable, again at the second postoperative visit. Age, sex, education level, and questionnaire scores were recorded. Ninety-eight patients completed the questionnaire preoperatively and scored an average of 70.7% correct answers. Seventy-five patients completed the first postoperative questionnaire, scoring an average of 59.5%. Thirty-nine patients completed the second postoperative questionnaire, scoring an average of 60.8%. The decline between the preoperative and the first postoperative score was significant. The mean score did not differ significantly according to sex at any time point. College-educated patients scored higher than patients without a college education did on both the preoperative and postoperative questionnaires, with the difference in the preoperative score being significant. Patients who were less than fifty years old scored higher than older patients did, with the difference in the postoperative score being significant. Patient comprehension and recall immediately following a thorough discussion of the consent form was unexpectedly low. This poor recall deteriorated further between the preoperative visit and the first postoperative visit (a period of no more than two weeks). Greater age and lower education level were associated with poorer comprehension. Sex did not affect any of the scores.

Clinical Ethics Committee Case 15: A case study in surgical consent – Mr X's appendix

Clinical Ethics Committee Case 15: A case study in surgical consent – Mr X's appendix

Clinical Issues—May 2011

This MonthFormalin storage and handlingKey words: formalin, formaldehyde, specimen handling.Immediate‐use sterilizationKey words: flash sterilization, immediate‐use sterilization.Precautions for treating patients with multidrug‐resistant organismsKey words: multidrug‐resistant organisms, MDRO, methicillin‐resistant Staphylococcus aureus, MRSA.Cleaning privacy curtainsKey words: environmental cleaning, privacy curtains, laundering, commercial laundry.Informed consentsKey words: surgical consent, implants, brand names, generic names.

Contents and readability of currently used surgical/procedure informed consent forms in Nigerian tertiary health institutions

Surgical informed consent forms should have evidence that their use will enhance a shared decision-making which is the fundamental objective of informed consent in clinical practice. In the absence of any guideline in Nigeria on the content and language of informed consent forms, we sort to examine the surgical and procedure consent forms used by Federal tertiary health institutions in Nigeria, to know whether they fulfill the basic elements of informed consent. The surgical and procedure informed consent forms of 33 tertiary health institutions in Nigeria were assessed for their readability and contents. Adequacy of their content was evaluated based on provision for 28 content items identified as necessary information to be provided in a good consent form. The potential of the forms to be comprehended were assessed with Flesch readability formula. The contents of majority of the forms were scant. None of the forms made provision for documentation of the patient's permission for blood transfusion, tissue disposal, awareness of the risks of not undergoing the prescribed treatment, and the risk of anesthesia. Risk disclosures were only mentioned in specific terms in 11.4% of the forms. Less than 10% of the forms made provisions for an interpreter, signature of anesthetists, alternative to the procedure to be mentioned, and answering of the patient's questions. The Flesch reading ease scores of the forms ranged from 34.1 (Difficult) to 67.5 (Standard), with a mean score of 55.2 (Fairly difficult level). Field evaluation of the forms show that they shall be partly understood by 13- to 15-year-old patients with basic education but are best understood by literate adult patients. The content of majority of the informed consent forms used in Nigerian tertiary health institutions are poor and their readability scores are not better than those used in developed parts of the world. Health Institutions in Nigeria should revise their informed consent forms to improve their contents and do a usability trial on the sample forms before deployment in order to ensure that they are comprehensible for their patient population.

Surgery in an Afghan population: is pictorial consent and injury pattern recognition identification of patients appropriate?

The aim of this study was to develop a safe way to obtain informed consent and ensure the correct patient was operated on in a generally poorly educated, non-English speaking Afghan patient population admitted to a military role 2 (enhanced) hospital facility. Prior to Herrick 9, surgical consent for Afghan patients was obtained via an interpreter in the traditional manner and documented on a U.K. formatted consent form (MOD form 660) (group 1) with patient identification largely being the responsibility of the interpreter. Patient agreement was documented by placing a thumbprint on the form. During Herrick 9, pictorial consent and injury pattern recognition (IPR) identification of patients was introduced. The consent was written as part of the case note narrative with diagrammatic representation of the injuries and the proposed surgery, which was explained by the interpreter (Group 2). We compared the consent and identification process for ten consecutive patients from each group. Each method of consent was examined for documentary evidence of the procedure, patient identification and method of patient agreement. The senior Afghan interpreter was asked for his personal views on the benefit or otherwise of the pictorial consent. For group 1, each of the nine MOD form 660s were completed in English by the operating surgeon and included details of the procedure. Seven had been signed by the interpreter. Each had a thumbprint on the form but there was no name or date alongside it. There was no way of confirming that the thumbprint was that of a particular patient. For group 2, pictorial consent was documented in the narrative with specific documentation of the injury pattern of that patient. Confirmation of consent and patient identification by IPR was by the operating surgeon. When possible, informed consent is required for all patients undergoing surgery in line with Department of Health guidelines. The use of pictorial consent and IPR identification, as part of patient documentation, would appear to be superior in this particular environment.

Clinical Issues—November 2010

This MonthResponsibility for obtaining the surgical informed consentKey words: surgical consent, consent for surgery, informed consent.Requirement for a history and physical examination before minor surgeryKey words: patient history, physical examination, H&P, minor surgical procedures.Marking instruments with color‐coded tapeKey words: instrument tape, color‐coded tape, sterilization.Wearing perfume in the perioperative settingKey words: perfume, fragrance‐free health care environments, sensory hyperreactivity.

Changes in surgical consent practices for common otolaryngology procedures: impact of Modernising Medical Careers

To assess elective surgery consent practices amongst senior house officers from a selection of UK ENT departments, and to compare results with similar surveys in 2002 and 2005. A telephone survey of senior house officers in 40 UK ENT departments was conducted to assess departmental consent policies and knowledge of complications of common ENT operations. A total of 77.5 per cent of responding senior house officers were responsible for consenting, reduced from 92.5 per cent in 2002 (p = 0.06). There had been a significant improvement in the use of patient information sheets, from 25 per cent of departments in 2002 to 65 per cent in 2008 (p = 0.0002). There had been no improvement in training or in the use of standard National Health Service consent forms, and the senior house officers' knowledge of specific complications remained poor. Of the senior house officers surveyed, 37.5 per cent were foundation trainees. There has been some improvement in information delivery to patients during the consent process, in accordance with General Medical Council, Department of Health and Modernising Medical Careers guidelines. However, most senior house officers are still required to obtain patient consent without appropriate training.

Capacity to Give Surgical Consent Does Not Imply Capacity to Give Anesthesia Consent: Implications for Anesthesiologists

There is precedent in medicine for recognizing and accepting intact decisional capacity and the subsequent ability to provide valid consent in one treatment domain, while simultaneously recognizing that the patient lacks decisional capacity in other domains. As such, obtaining consent for anesthesia for a surgical procedure is a separate entity from obtaining consent for the surgery itself. Anesthesia for surgery and the surgical procedure itself are separate treatment domains and as such require separate consents. Anesthesiologists should understand the independence of these functionally linked consent processes and be vigilant with respect to the informed consent process. The cases reported in this article show that capacity for surgical consent may be inadequate for consent to anesthesia because anesthesia involves more abstract concepts requiring a higher cognitive state than surgery, thus requiring a higher state of cognitive capacity for understanding.

Evaluación y mejora del manejo del consentimiento informado en urgencias

To assess the preoperative management in our emergency surgical service and to improve the quality of the care provided to patients. In order to find the causes of non-compliance, the Ishikawa Fishbone diagram was used and eight assessment criteria were chosen. The first assessment includes 120 patients operated on from January to April 2007. Corrective measures were implemented, which consisted of meetings and conferences with doctors and nurses, insisting on the importance of the informed consent as a legal document which must be signed by patients, and the obligation of giving a copy to patients or relatives. The second assessment includes the period from July to October 2007 (n=120). We observed a high non-compliance of C1 signing of surgical consent (CRITERION 1: all patients or relatives have to sign the surgical informed consent for the operation to be performed [27.5%]) and C2 giving a copy of the surgical consent (CRITERION 2: all patients or relatives must have received a copy of the surgical informed consent for the Surgery to be performed [72.5%]) and C4 anaesthetic consent copy (CRITERION 4: all patients or relatives must have received a copy of the Anaesthesia informed consent corresponding to the operation performed [90%]). After implementing corrective measures a significant improvement was observed in the compliance of C2 and C4. In C1 there was an improvement without statistical significance. The carrying out of an improvement cycle enabled the main objective of this paper to be achieved: to improve the management of informed consent and the quality of the care and information provided to our patients.