Informed consent for total knee arthroplasty: exploration of patient`s information acquisition and decision-making processes—a qualitative study
Research Article
Sandro Zacher, Julia Lauberger, Carolin Thiel, Julia Lühnen, Anke Steckelberg
BMC Health Services, 11 September 2023; 23(978)
Open Access
Abstract
Background
Total knee arthroplasty (TKA) is an option for the treatment of knee osteoarthritis (OA). Patients have high expectations regarding the benefits of the actual operation. Patients can seek a second opinion on the indication for TKA. In a study, less than half of recommended TKAs were confirmed by the second opinion and conservative treatments are not fully utilized. Informed consent forms that are used in Germany usually do not meet the requirements to support informed decision-making. Our aim was to describe the process from the diagnosis of knee OA through the decision-making process to the informed consent process for TKA, and to understand when, how, and by whom decisions are made. Moreover, we wanted to describe patients’ information needs and preferences about knee OA and its treatment, including TKA, and find out what information is provided. We also wanted to find out what information was important for decision-making and identify barriers and facilitators for the optimal use of evidence-based informed consent forms in practice.
Methods
We chose a qualitative approach and conducted semi-structured interviews with patients who were going to receive, have received, or have declined TKA, and with general practitioners (GP), office-based as well as orthopaedists and anaesthesiologists in clinics who obtain informed consent. The interviews were audio-recorded, transcribed and analysed using qualitative content analysis.
Results
We conducted interviews with 13 patients, three GPs, four office-based orthopaedists and seven doctors in clinics who had obtained informed consent. Information needs were modelled on subjective disease theory and information conveyed by the doctors. Patients in this sample predominantly made their decisions without having received sufficient information. Trust in doctors and experiences seemed to be more relevant in this sample than fact-based information. Office-based (GPs, orthopaedists) and orthopaedists in clinics had different understandings of their roles and expectations in terms of providing information.
Conclusions
We were able to identify structural barriers and assumptions that hinder the implementation of evidence-based informed consent forms.

Optimizing Informed Consent Discussions: Developing a Narrative for Transfusion Consent
Michelle P. Zeller, Marissa Laureano, Aditi Khandelwal, Shannon J. Lane, Richard Haspel, Mark Fung
Transfusion Medicine Reviews, 9 September 2023
Abstract
    Ensuring patient informed consent is a key tenet of modern medicine. Although transfusion of blood products is among the most common medical procedures performed in hospitalized patients, there is evidence that informed consent for transfusion is at times incomplete, poorly understood, hurried and/or inaccurate. This study aimed to develop a narrative that can be used as a framework for practicing physicians and for educational purposes to optimize the process for obtaining informed consent for blood transfusion.

The narrative was developed using a modified-Delphi approach with 5 Rounds that included feedback from Transfusion Medicine (TM) experts, transfusion-provider physicians and lay people. The surveys collected qualitative and quantitative data analyzed using thematic content analysis and descriptive statistics, respectively. Results from Round 1 and 2 generated a draft narrative and rounds 3 to 5 informed further modifications.

Round 1 included draft narrative scripts from 28 TM experts; thematic coding generated 97 topics. In round 2, 22/28 of the initial experts rated items identified from Round 1. Those with a Content Validity Index (CVI) ≥ 0.8 were used by the authors to develop a narrative. In Round 3, 20/24 participants from Round 2 reviewed the narrative with 100% agreeing on the items included and 90% agreeing the flow was logical. In Round 4, 23 transfusion prescribers (non-TM physicians) reviewed the narrative for flow, manner, length and usability; there was 83% agreement with non-exclusion of important topics; 91% felt it would be effective for teaching trainees. Round 5 included 24 non-medical lay people of different demographics. Most participants (92%) thought that the script was appropriate in length and there were opportunities to ask questions. Participants could also identify the adverse transfusion reactions and understood that they could refuse the transfusion. A narrative for obtaining informed consent for blood transfusion was created through multiple rigorous iterations of review and feedback with both transfusion providers and the lay public. The narrative, developed for a specific clinical scenario, was well-received by medical and non-medical participants and can be used, and modified, to help ensure patients understand the risks and benefits of blood transfusion.

Minimum standard assessment of informed consent for internal medicine transition to residency program: A cohort study
Mannat Marwaha, Raman Bhalla, Shivani Rao, Catherine Chen
Health Science Reports, 10 August 2023
Abstract
Background and Aims
Interns must be proficient in obtaining informed consent (IC), which is the Association of American Medical College’s 11th of 13 Entrustable Professional Activities (EPAs). Medical students have limited opportunity to practice IC during clerkships, resulting in inconsistent proficiency. We aimed to create a tool to assess whether our transition to residency (TTR) workshop enables fourth‐year medical students to meet a minimum standard of obtaining IC.
Methods
Sixty fourth‐year medical students were enrolled in the internal medicine virtual TTR course during AY2021. The curriculum prioritizes deliberate practice activities. Pre‐ and postworkshop assignments involved students typing verbatim what they would say during IC encounters. We modified an IC abstraction tool created by Spatz et al. to assess a minimum standard for students’ IC assignments. Our final 7‐item tool consisted of the following domains: “What,” “Why,” “How,” “Benefits,” “Quantitative Risks,” “Qualitative Risks,” and “Alternatives,” weighing 1 point each. A minimum standard was obtained with a score of 6 or more points by appropriately discussing at least one domain involving risk and all other domains.
Results
Students scored highly on the prework domains pertaining to “What,” “Why,” and “How” of the procedure with no significant difference on postwork. Significant improvement was achieved on postwork domains covering “Benefits” (p = 0.039) and “Alternatives” (p = 0.031). For domains involving “Qualitative” and “Quantitative Risks,” there were no statistically significant improvements from pre‐ to postwork scores. Fifteen and 22 students met the minimum standard for IC on pre‐ and postwork, respectively.
Conclusion
Our students demonstrated a good a priori understanding of the “What,” “Why,” and “How” domains. After the workshop, they more reliably discussed “Benefits” and “Alternatives.” Our abstraction tool helped assess the strengths and weaknesses in our students’ IC skillset and helped recognize areas of our curriculum that will benefit from improvements to bring students to meet the minimum standard.

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.

Angiography Consent—Communicating Risk Versus Benefit
Reynolds, G. Armstrong, R. Newcombe, T. Wijohn
Heart Lung and Circulation, July 2023; 32(3)
Abstract
Background and Aim
To produce health health-literate patient resources takes a village! It requires many iterations, opinions and feedback from writers, experts and, most importantly, consumers. This poster focuses on the health literacy input, breaking down medical terminology and complex words, seeking consumer feedback and adding images, to enable wider comprehension whilst developing a resource aimed at patient education prior to the consent process for invasive coronary angiography.
Context
The proportion of adults in Australia and New Zealand with reading at levels one or two is similar, at around 44%, meaning they are likely to struggle to understand sufficient health information to make truly informed choices; further compounded in indigenous people and residents with English as a second language. Our Cardiology team at Te Whatu Ora-Waitemata and from the University of Auckland noted a gap at our hospitals; patients had limited access to cardiology staff in wards outside the Cardiology department and largely had no pre-procedural information prior to arriving at the cath lab and being consented.
Progress
We are developing an accessible resource for people awaiting angiography as in-patients, to be educated concerning the process and risks involved for this procedure from the referral time, to enable informed and meaningful consent. The team researched patient understanding of statistical presentation of risk; this will also be available at this meeting.

Why don’t we inform patients about the risk of diagnostic errors?
Ömer Kasalak, Jan P. Pennings, Jeroen W. Op den Akker, Derya Yakar, Thomas C. Kwee
European Journal of Radiology, August 2023
Abstract
The principles of autonomy and informed consent dictate that patients who undergo a radiological examination should actually be informed about the risk of diagnostic errors. Implementing such a policy could potentially increase the quality of care. However, due to the vast number of radiological examinations that are performed in each hospital each day, financial constraints, and the risk of losing trust, patients, and income if the requirement for informed consent is not imposed by law on a state or national level, it may be challenging to inform patients about the risk of diagnostic errors. Future research is necessary to determine if and how an informed consent procedure for diagnostic errors can be implemented in clinical practice.