Can we do it better? Consent in dentoalveolar surgery
Short Communication
Jai Parkash Ramchandani, Miss Alice Cameron, Montey Garg, Laurence Newman
British Journal of Oral and Maxillofacial Surgery, 19 August 2023
Open Access
Abstract
Obtaining informed consent is essential for any medical or dental procedure. Dentoalveolar surgery poses numerous risks due to the complex environment and anatomy of the oral cavity. Failure to seek and correctly document consent may lead to claims in negligence, as demonstrated by the increasing litigation in OMFS. We audited dentoalveolar surgery consent forms at two different UK OMFS units and found that many forms failed to document important material risks associated with procedures. In attempt to improve the consent process, we developed a standardised form containing a list of risks for dentoalveolar surgery that can be affixed to the consent form. We suggest other OMFS units adopt this form to standardise the consent process and optimise patient care while protecting clinicians from medico-legal claims.

Transformative experience and the principle of informed consent in medicine
Original Research
Karl Egerton, Helen Capitelli-McMahon
Synthese, 18 August 2023; 202(65)
Open Access
Abstract
This paper explores how transformative experience generates decision-making problems of particular seriousness in medical settings. Potentially transformative experiences are especially likely to be encountered in medicine, and the associated decisions are confronted jointly by patients and clinicians in the context of an imbalance of power and expertise. However in such scenarios the principle of informed consent, which plays a central role in guiding clinicians, is unequal to the task. We detail how the principle’s assumptions about autonomy, rationality and information handle transformative experiences poorly, appealing to several difficult cases for medical decision-making to illustrate the resulting problem, and we consider how the existing literature on complications with consent fails to offer a resolution. We argue that recognition of the problem has a role to play in achieving a more effective response to transformative decisions. In Sect. 1 we introduce several representative cases of challenging patient decision-making that clinicians might face. In Sect. 2 we detail how transformative experience has been analysed in the recent literature, before outlining in Sect. 3 the theoretical basis of the principle of informed consent, which plays a central role in how clinicians are expected to support decision-making. In Sect. 4, having laid the groundwork for a clear description, we return to the cases given in Sect. 1 to confirm how their transformative nature presents a problem: either clinicians treat the decisions faced by these patients as ‘normal’, encouraging them to focus on information provision that patients may be unable to act on, or they treat them as transformative, in which case they lack the resources to recognise whether they are helping patients make (subjectively) good decisions. In Sect. 5 we argue that the existing literature does not offer any escape from this problem. We close in Sect. 6 by noting the significant impact that appreciating the problem of transformative experience could have on supporting transformative decisions in medicine and briefly suggesting how we might aim to develop new approaches to dealing with these.

Establishing an Ethics for Psychedelic Psychiatry
Brian Holoyda, Cameron Kiani
Psychiatric Services, 1 August 2023
Excerpt
…Informed consent, a cornerstone of ethical clinical practice, is particularly challenging in the context of psychedelic-assisted psychotherapy. The authors aptly point out that the potent effects of psychedelics necessitate an enhanced consent process to ensure understanding of risks and potential treatment outcomes. Patients should understand that acute and long-term emotional, cognitive, and perceptual changes may occur with psychedelic use. Although psychedelic journeys are positively transformative for many people, these journeys are not beneficial for everyone. Barber and Dike also note that psychedelics not only may be used to treat some mental disorders but also may lead to changes in personality and beliefs. Eliciting such changes could be outside the scope of psychiatric treatment; therefore, practitioners need to ensure that their patients’ understanding of the goals of treatment align with their own…

Ethical and Psychosocial Factors in the Decision-Making and Informed Consent Process for Upper Extremity Vascularized Composite Allotransplantation: A Mixed-Methods Study
Elisa J. Gordon, Jessica Gacki-Smith, Brianna R. Kuramitsu, Max Downey, Karen B. Vanterpool, Michelle J. Nordstrom, Tiffany Riggleman, Carisa M. Cooney, Sally Jensen, Gregory Dumanian, Scott Tintle, Macey Levan, Gerald Brandacher
Transplantation Direct, August 2023; 9(8)
Abstract
Background
Although upper extremity (UE) vascularized composite allotransplantation (VCA) aims to improve quality of life, relatively few have been performed worldwide to support evidence-based treatment and informed decision-making.
Methods
We qualitatively examined factors contributing to anticipated and actual decision-making about UE VCA and perceptions of the elements of informed consent among people with UE amputations, and UE VCA candidates, participants, and recipients through in-depth interviews. Thematic analysis was used to analyze qualitative data.
Results
Fifty individuals participated; most were male (78%) and had a mean age of 45 y and a unilateral amputation (84%). One-third (35%) were “a lot” or “completely” willing to pursue UE VCA. UE VCA decision-making themes included the utility of UE VCA, psychosocial impact of UE VCA and amputation on individuals’ lives, altruism, and anticipated burden of UE VCA on lifestyle. Most respondents who underwent UE VCA evaluation (n = 8/10) perceived having no reasonable treatment alternatives. Generally, respondents (n = 50) recognized the potential for familial, societal, cultural, medical, and self-driven pressures to pursue UE VCA among individuals with amputations. Some (n = 9/50, 18%) reported personally feeling “a little,” “somewhat,” “a lot,” or “completely” pressured to pursue UE VCA. Respondents recommended that individuals be informed about the option of UE VCA near the amputation date.
Conclusions
Our study identified psychosocial and other factors affecting decision-making about UE VCA, which should be addressed to enhance informed consent. Study participants’ perceptions and preferences about UE VCA suggest re-examination of assumptions guiding the UE VCA clinical evaluation process.

Impacting Risk Communication: Educating Providers to Improve Informed Consent Conversations in Procedural Sedation
Book Chapter
Raquel M. Schears, Fernanda Bellolio
The New Science of Medicine, 25 July 2023; pp 237–249 [Springer]
Abstract
    Patients that require procedural sedation (PS) in the emergency department (ED) are at risk of complications from emergency medical conditions that bring them to the ED plus the need for pain and anxiety management to successfully accomplish an intervention or diagnostic procedure. Explanation of the purpose, risks and benefits of PS is part of the informed consent. To participate in informed consent, patients need to understand what it is that they are agreeing to, and what are the risks and benefits of the procedure. Common challenges in these scenarios are that clinicians might not know the research evidence surrounding the risks and adverse events of the procedure, and present harms and benefits in general terms. Another challenge is that patients might not understand medical evidence when it is shared. To perform informed consent patients and providers need to actively participate sharing information and answering questions. Patients must have sufficient information if they are to make decisions that reflect their own values and preferences, and physicians play a key role as educators in this process.

We identified a gap in our process of informed consent for PS. To fill this gap, we examined the prior literature to gain insight regarding incidence of adverse events in sedation when performed in the ED setting. Baseline provider knowledge was assessed with a pretest, thereafter didactic presentations on PS risks were provided and followed up with a posttest 6 months later. In the interim, we gave providers an evidence-based risk of adverse events card to facilitate informed consent conversations with patients undergoing PS in the ED. Because providers may find it difficult to strike a balance between too much and too little information, we also made a video on how to incorporate serious adverse events (SAEs) risks in an informed consent process for PS and made it available online for review.

Lastly, an evidence-based visual decision aid (DA) was developed out of a 3-round iterative process using a modified Delphi exercise, and created as an adjunct to supplement (rather than replace) clinician counselling about the spectrum of sedation risks for use by providers with identified patients. The visual aid became the focal point of the new informed consent process for PS implemented in 2017. The genesis of the DA, was based on PS survey feedback and patients and providers’ perceptions of evidence-based audiovisual aids utility (study card, didactic presentation, informed consent simulation) judged to be helpful in communicating sedation risks, when obtaining consent in the ED.

Visual aids help to increase the knowledge of providers and patients when communicating the risks of procedures. Risks can be estimated and consistently reported by trained providers and can help engage patients in relevant risk conversation in routine practice. In other acute settings, DAs have been shown to improve information recall, have clear potential to alter patient experience and likely impact their perception of quality of care. The sustainability of ED provider-facilitated use of an evidence-based visual DA for PS with patients requires ongoing investigation. If interactive repetition builds on the value of evidence-based communication, then the impact of patient understanding regarding the risks of sedation may actually translate validity to the informed consent process.