Informed Consent and Shared Decision-Making in Modern Medicine. Case-based Approach, Current Gaps and Practical Proposal
Giuseppe Tarantini, Chiara Fraccaro, Andrea Porzionato, Nicolas Van Mieghem, Hendrik Treede, Nicolas Shammas, Molly Szerlip, Vinod Thourani, Gino Gerosa, Alfredo Marchese, Giuseppe Speziale, Bertrand Ludes, Stephen Pollak, Peter Vanezis, Santo Davide Ferrara
The American Journal of Cardiology, 25 January 2025
Open Access
Abstract
Advances in personalized medicine and Systems Biology have introduced probabilistic models and error discovery to cardiovascular care, aiding disease prevention and procedural planning. However, clinical application faces cultural, technical, and methodological hurdles. Patient autonomy remains essential, with shared decision-making (SDM) gaining importance in managing complex cardiovascular treatment options. Effective SDM relies on collaboration between providers and patients, guided by P5 Medicine principles, which combine psycho-cognitive considerations with predictive, personalized, preventive, and participatory care. Here we propose a three-step methodological proposal for implementing SDM and enhancing consent acquisition in cardiovascular care. The approach emphasizes personalized patient engagement and the need for clear, comprehensive consent processes. It identifies and addresses significant gaps in current practices, including the complexity of consent language, information dispersion, and the specific needs of vulnerable populations. Issues of Medical Responsibility and/or Liability may raise in the case of absence of consent acquisition or invalid consent due to insufficient/incorrect information. The International Guidelines on Medico-Legal Methods of Ascertainment and Evaluation Criteria are reported. In conclusion, the paper proposes practical solutions, including the use of artificial intelligence (AI) to enhance decision-making and patient counseling, and strategies to ensure that consent processes are both thorough and legally sound and respectful to the individual’s autonomy.

Bridging gaps in surgical consent: an audit from the SNAPS department
Digital Poster
Alizay Rehman, Jennifer Billington, Simon Blackburn
BMJ Paediatrics Open, 17 January 2025
Open Access
Abstract
Introduction
Consent for surgical intervention involves providing patients and their families adequate information and time to make informed decision. An outpatient clinic appointment is crucial for sharing information about surgical diagnosis and necessary interventions. Our objective was to audit the consent process in the Specialist Neonatal and Paediatric Surgery (SNAPS) department at Great Ormond Street Hospital.
Method
The gold standards were consent guidelines by the Royal College of Surgeons, General Medical Council, and National Institute for Health and Care Excellence.1–3 Guidelines recommend taking consent in advance of surgery, such as in clinics, allowing patients ample time to make informed decisions. The consultation should share the following to meet guideline criteria: diagnosis, planned surgery, alternatives, risks, benefits, expected postoperative stay, preoperative instructions, and reading material, all documented in clinic letters. Patients’ notes (clinic letters, consent forms, date of surgery) were retrospectively assessed. During the implementation phase, consensus regarding guidelines was achieved across the surgical team. Smart phrases were created and shared for EPIC clinic letters, meeting guideline criteria, for common SNAPS surgical procedures, followed by a re-audit.
Results
Clinic letters of 70 patients were audited in first cycle. Only 27/70 (38.9%) letters met the criteria. 68/70 (97%) consents were signed on the day of surgery, 2/70 (3%) the day before, with 0/70 in clinic. The average duration between consultation and surgery was 5.39 months. The re-audit analysed 70 letters and demonstrated improvement of 11.1% with 35/70 (50%) letters meeting the criteria as per guidelines.
Conclusion
We demonstrated moderate improvement in surgical consultations by ensuring patients receive adequate information, in accordance with gold standards, with documented evidence in clinic letters. Further progress requires enhancing consent processes in clinics allowing sufficient time for patients to make decision, including consent guidelines in doctor inductions, access to smart phrases and re-auditing after some months.

Documentation of Consent in Appendicectomy: A Closed Loop Quality Improvement Project
Ismay Fabre, Kellie Bateman, Anil Ghosh
British Journal of Surgery, 17 January 2025
Abstract
Aim
The aim of this quality improvement project was to enhance documentation of informed consent for patients undergoing diagnostic laparoscopy and/or appendicectomy, ensuring compliance with legal standards and the Montgomery ruling.
Methods
Retrospective data were collected in an initial audit followed by two Plan-Do-Study-Act (PDSA) cycles from handwritten consent forms of adult patients listed for emergency diagnostic laparoscopy and/or appendicectomy. Data included: grade of consenting clinician, pre-operative imaging, and documentation of recognised risks, for example, conversion to open and drain insertion. Interventions implemented between cycles included providing EIDO leaflets on the surgical unit and teaching consent practices during induction.
Results
Data from 54 patients were analysed (Initial=18, Cycle1=15, Cycle2=21). Consent was performed by SHO’s in 38%-47%. Significant improvements were observed in documenting risks such as blood transfusion (0% to 71.4%), drain insertion (16.7% to 85.7%) and adhesions (38.9% to 76.2%). Documentation of risks such as damage to structures, bleeding and infection remained above 90% throughout. EIDO leaflet use increased from 11.1% to 80.0% within the first cycle but decreased (66.7%) in the second. Overall documentation of COVID risk decreased from 66.7% to 28.6%.
Conclusion
The initial cycle revealed poor documentation of risks, correlating with lack of informed consent. Subsequent PDSA cycles demonstrated significant improvement, particularly in recording recognised risks such as blood transfusion, drain insertion and adhesions. These improvements align with the Montgomery ruling, which requires detailed disclosure of risks to patients. Continued focus and further implementation of information leaflets/ digital resources is required to ensure consistent practice.

Survey of Clinical Specialties Performing Informed Consent for Endovascular Thrombectomy
Mbonde, A. A. Alsarah, B. Demaerschalk, A. A. Dmytriw, Q. J. Moyer, J. A. Hirsch, A. B. Singhal, T. M. Leslie‐Mazwi, N. S. Rost, A. B. Patel, M. J. Young, R. W. Regenhardt
Stroke: Vascular and Interventional Neurology, 15 January 2025
Open Access
Abstract
Introduction
Informed consent (IC) plays a central role in acute stroke care, especially endovascular thrombectomy (EVT). We investigated the clinical roles and medical specialties of individuals who obtain IC for EVT, aiming to provide insights for enhancing the process.
Methods
We conducted a survey from July to December 2023 among clinicians involved in acute stroke care. Utilizing Qualtrics, we disseminated a structured questionnaire through various national and international platforms. This analysis summarizes findings on the characteristics of those who obtain EVT IC at the respondents’ institution.
Results
Among 168 participants,71% were staff physicians, 70% practiced in the United States (US), and 70% were based at academic centers. The most common medical specialties obtaining EVT IC were neurology (77%), followed by neurosurgery (41%), radiology (30%) and emergency medicine (10%) (Table 1). Staff physician (61%) was the most common clinical role involved, followed by fellows (43%), residents (48%), and advanced practice providers (APP, 36%) (Table 2). Non‐US institutions were more likely to utilize a provider from neurology alone (50% vs. 31%, p=0.016) and staff physicians (76% vs. 54%, p=0.008), while US institutions were more likely to utilize providers from neurosurgery (51% vs. 18%, p<0.001), APPs (43 vs. 18%, p=0.002) and residents (56% vs. 28%, p=0.001). Non‐academic institutions more frequently used emergency medicine providers (25% vs. 5%, p<0.001) and APPs (50% vs. 31%, p=0.031), while academic institutions commonly utilized neurosurgery providers (48% vs. 18%, p=0.001), residents (59% vs. 13%, p<0.001) and fellows (52% vs. 18%, p<0.001).
Conclusion
This study highlights the diverse medical specialties and clinical roles of persons obtaining IC for EVT, with neurologists and staff physicians being the most frequently utilized. These variations likely reflect availability and capacity of certain providers in different settings. Future efforts to optimize the IC process should be multi‐disciplinary, with standardized content that addresses provider diversity.

Mixed methods study of the interfacility transfer system utilizing both patient-reported experiences and direct observation of the transfer consent process
L Stewart, D Bille, B Fields, L Kemper, C Pappa, E Orman, M Boustani, E Ramly, A Hybarger, A Watters, N Glober
The Joint Commission Journal on Quality and Patient Safety, 14 January 2025
Abstract
Background
Interfacility transfer is an integral component of the modern healthcare system. However, there are no commonly agreed-upon standards for interfacility processes or for patient engagement and shared decision-making in transfer, and little is known about their experience. This study used qualitative methods to better understand the patient and care partner experience with interfacility emergency department (ED)-to-ED transfer.
Methods
This mixed methods study used two distinct data sources: (1) semi-structured interviews of older adult patients and their care partners, performed at bedside in a large, tertiary care hospital (i.e., receiving facility) following interfacility transfer, and (2) direct observation of the transfer consent process at two community emergency departments (i.e., referring facilities) in the same health system.
Results
A total of 21 patients and 14 care partners were interviewed. We identified several common themes related to perceptions and experiences with interfacility transfer: (1) communication (e.g., perceived lack of agency), (2) logistics (e.g., wait times), (3) impacts on family (e.g., distance from home), (4) uncertainty about the bill (e.g., transfer-associated costs), and (5) quality of care (e.g., greater trust in tertiary care centers). We also conducted direct observations of the transfer consent process for 14 unique patient encounters. We observed considerable variability in practice patterns among sending clinicians and identified frequent patient-reported issues related to transfer logistics and effective communication, including distractions, lack of privacy, absence of support system, physical pain and/or psychological stress, preferred language, and health literacy.
Conclusions
These data suggest several potential areas for improvement in the care of patients requiring interfacility transfer, to increase engagement and allow patients and their care partners to make better-informed decisions most consistent with their goals of care.

Departmental practice on informed consent in radiotherapy departments: a UK evaluation
Marie Orr, Keeley Rosbottom
Journal of Radiotherapy in Practice, 9 January 2025
Abstract
Introduction
Valid and informed consent in healthcare is an ethical and legal requirement. This evaluation reports the practices within UK radiotherapy departments surrounding consent processes and therapeutic radiographer (TR) education. This article focuses on those patients who are considered to lack the capacity to consent.
Method
This service evaluation adopted a qualitative research design. Seventy-six radiotherapy department managers were sent the online survey: containing a combination of open, closed and free text questions relating to consent practices. Descriptive analysis using Microsoft Excel was performed; additional correlation analysis was attempted with Fisher’s exact test using Statistical Package for the Social Sciences.
Results
TRs from 39 radiotherapy departments (51%) completed the survey. Analysis of results demonstrated obtaining written consent before radiotherapy treatment was completed in all departments. Assessment methods used to determine capacity to consent varied across the departments. Responses identified 37 departments employ a different consent form for those considered to lack capacity. Thirty-eight departments have a policy surrounding consent; 16 departments reported no formal TR education in consent. Of the remaining 22 departments, 13 departments included lack of capacity within their education package.
Conclusion
To ensure best practice throughout the UK, is it recommended that radiotherapy departments review their consent processes to ensure they are in the best interests of the patient. It is recommended that TRs are familiar with their regulatory body standards and the ethical and legal issues surrounding consent; all departments should consider capacity and those considered to lack capacity within their education and training framework.

Informed Consent in Psychedelic-Assisted Therapy
Book Chapter
Mazdak M. Bradberry, Paul S. Appelbaum, Natalie Gukasyan
Current Topics in Behavioral Neurosciences, 31 December 2024 [Springer]
Abstract
Humans have long used classical serotonergic psychedelics, such as psilocybin, for a variety of purposes. Entactogens, such as methylenedioxymethamphetamine (MDMA), emerged during the twentieth century and have likewise seen use in a broad range of settings. Interest has arisen in the use of classical psychedelics and entactogens, together termed “psychedelics,” for therapeutic purposes in Western clinical settings. Care in these settings is governed by standards for the communication and assumption of risk in the process of informed consent. Rigorous informed consent standards in psychedelic medicine are not only essential for quality care but also critical to the mitigation of risk, particularly in research settings and for vulnerable individuals. This chapter describes practical elements of informed consent in psychedelic therapy, with a focus on effective communication of the risks and potential benefits of classical psychedelic and entactogen treatments as they are currently understood.

Promoting trans patient autonomy in surgical preparation for phalloplasty and metoidioplasty: results from a community-based cross-sectional survey and implications for preoperative assessments
Research
Leo L. Rutherford, Elijah R. Castle, Noah Adams, Logan Berrian, Linden Jennings, Ayden Scheim, Aaron Devor, Nathan J. Lachowsky
BMC Medical Ethics, 31 December 2024
Open Access
Abstract
Background
Some transgender and nonbinary people undergo phalloplasty and/or metoidioplasty as part of their medical transition process. Across surgical disciplines, a variety of resources are used to assist patients who are preparing for surgeries, including educational materials, workshops, peer support, and lifestyle changes. For gender-affirming surgeries, patients undergoing assessments to discern whether they are ready to undergo the surgery, and to assist them in achieving preparedness when needed. Little research investigates what resources are useful in helping patients to feel prepared to undergo phalloplasty or metoidioplasty, and how assessments and resources can promote patient autonomy in the process. Respect for patient autonomy is one of the central tenets of ethical healthcare, yet historically, scholarship related to pre-surgical assessments for gender-affirming surgery has focused determining the ideal surgical candidate rather than respecting patient autonomy and ascertaining individual patient needs.
Methods
This study sought to fill this gap by utilizing data from PROGRESS (Patient-Reported Outcomes of Genital Reconstruction and Experiences of Surgical Satisfaction), a cross-sectional, community-based survey of trans and nonbinary adults from the United States of America and Canada who had undergone one or more of these surgeries.
Results
Results revealed most participants (86%, n = 186) felt prepared to undergo surgery, though the majority of our sample (53%, n = 105) did not find referral letter assessments to be helpful. Peer support such as online resources/blogs were rated as highly useful, along with surgical consults. In a multivariable logistic regression, higher perceived preparedness was associated with identifying as queer (inclusive of gay, bi and pansexual compared to being straight), and feeling that one’s assessment process was useful (as opposed to not useful). Type of assessment was not significantly associated with preparedness; therefore, what is most useful when preparing for surgery may vary across individuals.
Conclusion
Healthcare professionals who interact with preparing patients should develop new or utilize existing resources to assist patients in identifying their preparation needs and achieving preparedness. Our data supports assessments that center surgical care planning rather than assessing level of gender dysphoria. Future longitudinal research could further refine which assessment processes are most effective in helping patients who are preparing for these surgeries. Assessments should ensure that patients are appropriately prepared to undergo and recover from surgery through a robust process of informed consent.

Maternity Care Informed Consent Practices and Perspectives: A Qualitative Study at a Tertiary Maternity Unit
Sally Ely, Susanne Langer, Hans Peter Dietz, Ka Lai Shek
The Australian & New Zealand Journal of Obstetrics & Gynaecology, 30 December 2024
Abstract
Background
Although consent has long been accepted as necessary in maternity care, the concept of informed consent for planned vaginal birth has polarised maternity politics. The publication of the NSW Consent Manual outlines new standards of informed consent, signalling the need for examination of current maternity consent practices.
Aims
To examine informed consent and disclosure of material risks in birth in a prospective qualitative study of midwives and obstetricians.
Materials and methods
Qualitative study using semi-structured interviews to examine practices and perspectives of obstetricians and midwives.
Results
Twenty-two telephone interviews were concluded. Five sub-themes were identified: (1) non-compliance with the NSW Consent Manual, (2) risk communication/informed consent in maternity care, (3) consent practices in instrumental birth, (4) who should deliver risk information and when (5) barriers to change in consent practice (obstetricians only).
Conclusions
One hundred per cent of participants (18 obstetricians, 4 midwives) described risk communication/informed consent practices that were non-complaint with the standards set out in the 2020 NSW Consent Manual. Eighty-three per cent (15/18) of obstetricians reported that current hospital-wide maternity care practices in risk communication/informed consent are inadequate. Sixty-one per cent (11/18) of obstetricians specifically singled out informed consent practices regarding instrumental birth to be inadequate. Ninety-four per cent (17/18) of obstetricians believe that maternity care consent practices need to be improved. The results of this study indicate that material risks of vaginal birth, caesarean section and instrumental birth, are not routinely disclosed during antenatal courses. Urgent resources and structural change are required to uphold women’s legal right to bodily autonomy.

Ethics of the fiduciary relationship between patient and physician: the case of informed consent
Extended essay
Sophie Ludewigs, Jonas Narchi, Lukas Kiefer, Eva C Winkler
Journal of Medical Ethics, 23 December 2024
Abstract
This paper serves two purposes: first, the proposition of an ethical fiduciary theory that substantiates the often-cited assertion that the patient–physician relationship is fiduciary in nature; and second, the application of this theory to the case of informed consent. Patients’ decision-making preferences vary significantly. While some seek fully autonomous decision-making, others prefer to delegate parts of their decision. Therefore, we propose an ethical fiduciary theory that allows physician and patient to jointly determine the physician’s role on a spectrum from fiduciary as advisor to fiduciary as agent. Drawing on legal concepts of the fiduciary relationship and on phenomenological accounts of obligation by Lévinas and Løgstrup, our theory relies on the key attributes of trust, vulnerability and otherness. Finally, practical implications of this theory for the informed consent process are developed: we propose a preassessment of patients’ risk and value profiles as well as a restructuring of the oral consent interview and the written consent materials.