Infrainguinal Bypass Informed Consent: An Audit Driven Standardisation Of Perioperative Risk Profiling
K Muhammad, H Al-Khaffaf
British Journal of Surgery, 12 October 2021; 108 (Supplement 6)
Abstract
Introduction
It is a fundamental good clinical practice in our medicolegal rights era to obtain standard, adequate, and transparent informed consent before any planned intervention. Currently, there are neither national approved vascular intervention-specific consents nor explicit guidelines for it. We aim to achieve a standardisation of perioperative risk profiling of infrainguinal bypass surgical consents and produce a model one.
Method
A retrospective analysis of 45 infrainguinal bypass consents (audit/reaudit) between (2013-2019) retrieved to evaluate quality and completeness against GMC 2008 guidance: “Consent: patients and doctors making decisions together”. Data included basic consent requirements according to guidelines and specific risks of infrainguinal bypass. It was registered with the Trust Clinical Audit Department.
Results
(100%) of audit and reaudit consents documented the intended benefits of surgery. Inclusion into the National Vascular Registry (NVR) was achieved (0%) in audit vs (80%) in reaudit forms. Of the 19 documented postoperative complications, reaudit significant improvement observed in % of documenting 16 items with 9 complications recorded above 50%. The maximum number of audit documented risks was 15 (79%), the median 8 (42%), and the least was 3 (16%) compared to maximum 16 (84%), the median 10 (53%) and the least was 4 (21%) when reaudited, respectively.
Conclusions
Deficiencies in performing and adequately completing surgical consents still occur. Introducing a national pre-printed vascular intervention-specific consent is vital for accomplishing and maintaining a good clinical practice. It should include all complications with relative % risk to minimise errors, provide good quality consent, and promote clinical practice at a national level.

A Question of Consent—Coercion and Consent to Lobotomy, 1946–1958 [BOOK CHAPTER]
Jesper Vaczy Kragh
Lobotomy Nation, 10 October 2021; pp 291-335 [Springer]
Abstract
This chapter investigates a topic that has not been addressed in the literature on psychosurgery, i.e. the question of consent to lobotomy. The performance of lobotomy required the psychiatrist to obtain the consent of the patient, or his or her next of kin, to the treatment. The chapter analyses the role played by the consent requirement when neurosurgery was being considered. The consent issue gives an insight into the patient-doctor relationship and how psychiatrists interpreted patients’ rights in the 1940s and 1950s. In addition, consent practices show that there were tensions between psychiatrists and neurosurgeons who had different views about this. The consent question was significant to the discontinuation of psychosurgery, since the initial criticism of the treatment was raised due to complaints concerning lacking consent.

Rehearsal’s effect on long-term recall and comprehension of orthodontic informed consent
Original Article
American Journal of Orthodontics and Dentofacial Orthopedics, 5 October 2021
Alexander R. Desman, Henry W. Fields, Andy Ni, Fonda G. Robinson, Brennan Skulski, Allen R. Firestone, David J. Heinlein
Abstract
Introduction
The purpose of this study was to determine if written rehearsal of informed consent improved 6-month recall and comprehension compared with the current best practices.
Methods
A consultation was provided and subjects read the modified informed consent document. They were randomized to group A (received the core and up to 4 custom elements of treatment, wrote what each image displayed) or group B (presentation of the 18 elements with core elements chunked at the end followed by up to 4 custom elements). Interviews recording knowledge recall/comprehension occurred immediately and after months later.
Results
Overall, no significant differences in baseline or 6-month follow-up scores were found between groups. Initially, group A outperformed group B in some core domains. There were no significant differences between groups in the change of scores from initial to follow-up. Follow-up scores were significantly lower than baseline scores (P <0.05). Higher initial scores were associated with larger drops at follow-up. A decrease in knowledge >20% was common.
Conclusions
Overall the methods are comparable at baseline and 6-months. Initial content retention was roughly 60+%, with 6%-9% deterioration. For areas of treatment methods, risk, discomfort, and resorption at 6-months, the current processes failed the patient and left the practitioner vulnerable to risk management issues. Results support the rehearsal method with immediate feedback for misunderstandings as the preferred method for informed consent.

Consent for septoplasty: Are we meeting patients’ expectations?
Research Article
Haseem Raja, Rishi Talwar
Medico-Legal Journal, 4 October 2021
Abstract
The requirements for informed consent were modified in 2015 following the UK Supreme Court judgment of Montgomery v Lanarkshire Health Board. This marked a decisive shift from the traditional paternalistic ‘doctor knows best’ model towards a more patient-centred approach. This study examines the current standard of consent for septoplasty and whether it complies with the law. We also report whether the ‘reasonable patient’ and surgeon agree about which risks should be discussed during the consent process. Ten complications were identified as common or serious via a literature search. Using questionnaires, 21 Ears, Nose and Throat surgeons were asked which of these they routinely discussed, and 103 patients were asked how seriously they regarded those complications. Results were compared using the Test of Proportions. Most surgeons routinely discuss all risks except negative change in sense of smell and numbness of upper incisors. The ‘reasonable patient’ regarded these two complications as serious or very serious. However, less than 70% of surgeons mentioned them. A significant proportion of Ears, Nose and Throat surgeons do not routinely mention all the risks that the ‘reasonable patient’ would want to know about before undergoing a septoplasty. This may result in more clinical negligence claims, as managing a patient’s reasonable expectations is an important factor.

Informed Consent, Advance Directives, and Shared Care Planning [BOOK CHAPTER]
Giuseppe Renato Gristina
Palliative Care in Cardiac Intensive Care Units, 30 September 2021; pp 83-97 [Springer]
Abstract
Knowing patient wishes regarding treatment acceptance or refusal is an essential aspect of care strategy, based on the principle of autonomy. In clinical practice, ignoring patient wishes or not taking them into proper consideration can lead to ethical and legal issues. In most cases patients hospitalized in general or specialized intensive care units (e.g., ICUs or cardiac intensive care units—CICUs), are unable to make autonomous decisions regarding their treatment due to disease severity. As a consequence, advance directives (ADs) could be a particularly effective tool to adequately guide doctor conduct with respect to patient values and wishes. In the USA and in many European countries, ADs have now been integrated in their legal systems but, despite their popularity, ADs have not yet achieved the expected result. In contrast, shared care planning (SCP) has been more successful. SCP is the process by which the quality of future patient care is discussed and planned according to the patient’s values and preferences. Planning involves the patient, the healthcare professionals, and the family members. On one hand SCP can improve planning of future care for patients with advanced cardiovascular disease and document their preferences; on the other hand, it is unclear what role SCP has in improving the quality of patient life, reducing depression often associated with the disease, and increasing the caregiver satisfaction.

The Principle of Consensualism in Informed Consent Between Doctor and Patient
Lintang Yudhantaka, Mas Anienda Tien Fitriyah, Rosalia Dika Agustanti
Hang Tuah Law Journal, 20 September 2021; 5(1) [Indonesia]
Abstract
The term informed consent or consent for particular medical treatment was familiar in medical world. It brought security for both doctors who did their profession and patients who got information about the illness they were suffering from along with any medical treatment they would have. In fact, there were still many problems issued due to less-well implementation of informed consent. Therefore, this study aimed to analyze the characteristics of informed consent as the legal basis between doctor and patient and verify the establishment of agreement (i.e., consensus) in informed consent. It was a juridical-normative research with conceptual and statute approaches. The result of this study found that informed consent had distinctive characteristics compared with any other common agreements, in particular to its subject, object, and cause. Towards the establishment of consensus, it referred to the doctor’s offering to do any medical treatment and patient’s acceptance to have that treatment.

Patients’ understanding of “informed consent” in plastic surgery
José Neder, Netto Roberto, Augusto de Carvalho Campos, Reginaldo Raimundo Fujita
Revista da Associação Médica Brasileira, August 2021; 67(8) [Brazil]
Summary
Objective
To assess the patient’s understanding of the informed consent form before and after plastic surgery.
Methods
This was a prospective analytical descriptive study that utilized a questionnaire on informed consent before and after plastic surgery procedures.
Results
Comprehension of informed consent was higher before surgery than after surgery (p=0.016; question 15). The higher the scholarity, the higher the comprehension (s=0.151; p=0.045) before surgery (question 4). For the other questions, it was not possible to find a difference in the pattern of understanding and in the association with the educational attainment level after surgery (s=0.180; p=0.046; question 1).
Conclutions
The patients’ level of comprehension of the details, outcomes, possible complications, and postoperative evolutions of surgical procedures, as stated by the informed consent form, is high.

Do hospital consent forms for cardiology procedures meet health literacy standards? Evaluation of understandability and readability
Ruwani Peiris, Samuel Cornell, Kim Greaves, Carissa Bonner
Patient Education and Counseling, 14 September 2021
Abstract
Objectives
Consent forms that are difficult to understand may jeopardize informed consent. The aim of this study was to determine whether consent documents for cardiology-related procedures could be easily read and understood by patients with low health literacy.
Methods
All 37 cardiology-related consent forms with patient information material were retrieved from a publicly available suite of documents from one state in Australia. Two raters independently assessed documents and resolved discrepancies through discussion. Understandability was assessed using the Patient Education Materials Assessment Tool for Printed materials (PEMAT-P). Readability was assessed using the Gunning Fog Index, SMOG and Flesch Reading Ease formulas. Images were assessed using the 5C Image checklist. Results were analyzed descriptively.
Results
Only 1 of 37 forms met the general PEMAT-P threshold (70%) for being ‘understandable’. The average readability score was high, requiring a grade 10–12 level of education to understand. Most images lacked useful captions, had low visual clarity, and were not purpose-designed for the material.
Conclusions
The current format for cardiology consent forms does not meet recommended standards for understandability and readability.
Practice implications
Development of consent forms would benefit from taking health literacy principles into account with patient input, and purpose-designed images should be included in all forms to reinforce text.

The ethics of informed consent and shared decision-making in pediatric surgery
Deborah S. Loeff, Baddr A. Shakhsheer
Seminars in Pediatric Surgery, 5 September 2021
Abstract
Informed consent is a required feature in the practice of pediatric surgery. Surgeons cannot practice the trade without it and most of us learned to do it as part of our “apprenticeship” in surgical training. We were bystanders when the senior resident or attending spoke to the patient and family and we were silent witnesses to the signing of the document called a “consent.” Intentional instruction about informed consent is rudimentary in most residencies. By the time we become surgical fellows, it is assumed that we have the requisite skill set to perform this “task” so we can get on with what we like to do best; operating. For many, it is viewed as a perfunctory step which, if done properly, will comply with hospital policies, might someday be exhibited during medical litigation, and ultimately it will occupy a tiny bit of memory in the hospital EMR system. However, this “thing” called the informed consent is much more than an item on a pre-op check list. The re-branding of the term “informed consent” into “shared decision-making” underscores the “re-evolution” that has occurred in thought and practice from the act of obtaining an individual’s permission for treatment toward the process leading up to that act.1 It reflects some of our most important ethical values in healthcare and is still the source of scholarly inquiry and controversy. In this paper, the terms “informed consent” and “shared decision-making” will be used interchangeably but the intention is focused on the process of how physicians and their patients make choices together. If you have not thought about this topic recently, I encourage you to take a moment and explore some of the interesting and challenging questions which are still unanswered. Although the ethical principles underlying informed consent are shared by adult and pediatric medicine, there are many aspects which are unique to the medical care of children. This article highlights some of those challenges and controversies illustrated by two case studies and viewed through the lens of bioethics.

A Survey to Assess the Informed Consent Practices of Physicians Caring for oocyte Donors
Christina Shields, Winifred Mak
Fertility and Sterility, 1 September 2021; 116(3)
Abstract
Objective
With increasing demand for donor oocytes, appropriate informed consent of oocyte donors (OD) is a priority as these women assume risk for a procedure that does not directly benefit them. Our study sought to investigate how physicians counsel on risks as part of informed consent of OD.
Materials and Methods
Physicians involved in the care of OD were invited to complete an anonymous 17-question online survey which included demographic variables and assessment of counseling practices such as whether short- and long-term complications are discussed with OD. The University of Texas Institutional Review Board approved the study.
Results
96 physicians responded (estimated response rate 17%). Respondents work in academic institutions (48%), private fertility clinics (46%), practices affiliated with commercial egg banks (6%), practices affiliated with academic institutions (11%), and are located across the Northeast (30%), Southeast (23%), Midwest (27%), Southwest (8%), and West (12%). Respondents in our study most often obtain consent either in person only or in person with other educational material. 98% responded that they always counsel on short-term potential side effects, versus 70% who always counsel on long-term potential side effects. A majority reported counseling on the incidence of ovarian hyperstimulation syndrome (OHSS) as 1-5% and acute serious complication (ASC) as <0.5% in accordance with the American Society for Reproductive Medicine (ASRM) bulletin on oocyte donation. The most discussed side effects are moderate pain / discomfort (100%), OHSS (96%), bloating (93%), intraperitoneal bleeding (79%), infection (78%), and ovarian torsion (78%). Interestingly, 21% also discussed general risk of cancer and 26% discussed risk of ovarian cancer. Regarding the maximum number of oocyte donation cycles, 65% of physicians recommend no more than 6 cycles and 32% recommend 3-5 cycles. Only 56% of respondents are aware of literature investigating long-term health outcomes of OD. Finally, 78% agree or strongly agree there should be a modality to track long-term health outcomes of OD.
Conclusions
Reassuringly, the majority of the physicians in our study counsel OD appropriately according to the ASRM guidelines and therefore from a physician’s perspective, appropriate informed consent is being obtained. There is a knowledge gap on long-term health outcomes of OD, likely due to lack of research in this area. Most physicians caring for OD agree that long-term health outcomes should be tracked.