The Two Pillars of Intensive Care Medicine (II): The Patient’s Wishes and Consent
Book Chapter
Aimee B. Milliken, Nicholas Sadovnikoff
Ethics in Intensive Care Medicine, 20 July 2023 [Springer]
Abstract
In this chapter, we review the second pillar of intensive care medicine: the patient’s wishes and informed consent. First, we review the concept of respect for autonomy and then address its corollary, the concept of informed consent. We discuss decision-making capacity and voluntariness as essential preconditions to a fully informed consent. Finally, we address the practice of shared decision-making.

How surgeons use risk calculators and non-clinical factors for informed consent and shared decision making: A qualitative study
Original Research Article
Jasmine Panton, Brendin R. Beaulieu-Jones, Jayson S. Marwaha, Alison P. Woods, Drashko Nakikj, Nils Gehlenborg, Gabriel A. Brat
American Journal of Surgery, 10 July 2023
Abstract
Background
The discussion of risks, benefits, and alternatives to surgery with patients is a defining component of informed consent. As shared-decision making has become central to surgeon-patient communication, risk calculators have emerged as a tool to aid communication and decision-making. To optimize informed consent, it is necessary to understand how surgeons assess and communicate risk, and the role of risk calculators in this process.
Methods
We conducted interviews with 13 surgeons from two institutions to understand how surgeons assess risk, the role of risk calculators in decision-making, and how surgeons approach risk communication during informed consent. We performed a qualitative analysis of interviews based on SRQR guidelines.
Results
Our analysis yielded insights regarding (a) the landscape and approach to obtaining surgical consent; (b) detailed perceptions regarding the value and design of assessing and communicating risk; and (c) practical considerations regarding the future of personalized risk communication in decision-making. Above all, we found that non-clinical factors such as health and risk literacy are changing how surgeons assess and communicate risk, which diverges from traditional risk calculators.
Conclusion
Principally, we found that surgeons incorporate a range of clinical and non-clinical factors to risk stratify patients and determine how to optimally frame and discuss risk with individual patients. We observed that surgeons’ perception of risk communication, and the importance of eliciting patient preferences to direct shared-decision making, did not consistently align with patient priorities. This study underscored criticisms of risk calculators and novel decision-aids – which must be addressed prior to greater adoption.

Informed Consent for Image-Guided Procedures: A Nationwide Survey of Perceptions and Current Practices
Forsman, S. Silberstein, E.D. Cyphers, E.J. Keller, M.S. Makary
Clinical Radiology, 29 June 2023
Abstract
Aim
To characterise the current landscape of informed consent practices for image-guided procedures, including location of consent, guideline availability, and utility of decision-aid resources.
Materials and methods
A survey of 159 interventional radiologists was conducted from April through June 2022. The survey evaluated participant demographics (gender, practice type, and level of training) and consent practices. Fifteen questions investigated discussion of benefits, risks, and alternatives, who obtained consent, location of consent conversations, how decision-making capacity is assessed, availability of formal guidance on consent discussions, and if and how decision-aids are used.
Results
Most respondents (93.7%) were “extremely” or “very” comfortable discussing the benefits and risks of image-guided procedures during informed consent. Most respondents were “very” comfortable discussing alternative treatments within radiology (86.8%) while fewer felt confident regarding alternatives outside radiology (46.5%). Most respondents indicated obtaining consent in a pre-procedure area (89.9%,), while 12.7% of respondents obtained consent in the procedure room. Of the respondents, 66.7% did not have formal education or documented guidance on what providers should disclose during consent. Ninety-two respondents (57.9%) reported using decision aids. The type of decision aid varied, with most reporting using illustrations or drawings (46.6%). Decision aid utility was more prevalent in non-teaching/academic (71.4%) versus academic (61%) institutions (p=0.02).
Conclusion
Regardless of demographics, interventionalists are confident in discussing benefits, risks, and alternative image-guided therapies, but are less confident discussing alternative treatment options outside of radiology. Formal education on informed consent is less common, and the use of decision aids varies between teaching and non-teaching institutions.

Perspectives on Current Attitudes, Enablers, and Barriers to Obtaining Surgical Informed Consent for Doctors-in-Training
Mary Teoh, Daniel Jia Wei Lee, David Cooke, Munyaradzi G Nyandoro
Cureus, June 2023; 15(6)
Abstract
Background
Surgical informed consent (SIC) is paramount in modern-day litigious surgical practice, yet numerous complaints remain about the consenting process. This paper investigated current attitudes, enablers, and barriers to obtaining SIC in clinical practice for doctors-in-training (DiT).
Methodology
Self-reported SIC practice among DiT (N=1,652) across three metropolitan health service regions in Western Australia (WA) was surveyed using a de-identified 20-item multiple response ranking, dichotomous quantitative and qualitative online survey. Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 27 (IBM Corp., Armonk, NY, USA).
Results
The response rate was 23% (n=380). There was an even distribution of key demographics across all three health regions; the median postgraduate year (PGY) was two. Only 57.4% of DiT strongly felt comfortable and confident obtaining a SIC. Of the responders, 67.4% correctly identified key SIC components. There were significant positive associations between comfort and confidence with obtaining SIC and the seniority level of the DiT (p<0.001), identification of SIC components (p<0.001), and prior training in SIC (p<0.001). Most DiTs highlighted the necessity for formal SIC training with a preference for interactive workshops supported by e-learning modules.
Conclusions
Most DiTs can identify the key factors that constitute a valid SIC; however, the practical conversion of this skill could be better. The key enablers to improved SIC techniques were well-supported departments, with further training and clear guidelines within the institutions. The identified barriers were time constraints, inexperience, and a lack of senior support. Future practices and interventions should address these key barriers while promoting the enablers of sustainable and efficient SIC practice.

Informed consent process for emergency surgery: A scoping review of stakeholders’ perspectives, challenges, ethical concepts, and policies
Olivia Kituuka, Ian Guyton Munabi, Erisa Sabakaki Mwaka, Moses Galukande, Michelle Harris, Nelson Sewankambo
SAGE Open Medicine, 16 June 2023
Open Access
Abstract
Background
A scoping review of literature about the informed consent process for emergency surgery from the perspectives of the patients, next of kin, emergency staff, and available guiding policies.
Objectives
To provide an overview of the informed consent process for emergency surgery; the challenges that arise from the perspectives of the patients, emergency staff, and next of kin; policies that guide informed consent for emergency surgery; and to identify any knowledge gaps that could guide further inquiry in this area.
Methods
We searched Google Scholar, PubMed/MEDLINE databases as well as Sheridan Libraries and Welch Medical Library from 1990 to 2021. We included journal articles published in English and excluded non-peer-reviewed journal articles, unpublished manuscripts, and conference abstracts. The themes explored were emergency surgery consent, ethical and theoretical concepts, stakeholders’ perceptions, challenges, and policies on emergency surgery. Articles were reviewed by three independent reviewers for relevance.
Results
Of the 65 articles retrieved, 18 articles were included. Of the 18 articles reviewed, 5 addressed emergency informed consent, 9 stakeholders’ perspectives, 7 the challenges of emergency informed consent, 3 ethical and theoretical concepts of emergency informed consent, and 3 articles addressed policies of emergency surgery informed consent.
Conclusion
There is poor satisfaction in the informed consent process in emergency surgery. Impaired capacity to consent and limited time are a challenge. Policies recommend that informed consent should not delay life-saving emergency care and patient’s best interests must be upheld.

Creation of a risk of harms informed consent form for dry needling: A nominal group technique
Edmund C. Ickert, David Griswold, Ken Learman, Chad Cook
Musculoskeletal Science and Practice, August 2023
Abstract
Background
When consenting patients to dry needling treatment, it is necessary to inform patients of potential risks of harms.
Objectives
The aim of this study was to identify elements and framework for an Informed Consent (IC) risk of harm statement to improve patient decision-making.
Design
A virtual Nominal Group Technique (vNGT) methodology was used to achieve consensus among participants to identify what needs to be on a consent form, how it should be framed, and what it should state so patients understand the true risks.
Methods
Eligible participants were identified as one of four groups: legal expert, policy expert, dry needling expert, or patient. The vNGT session consisted of 5 rounds of idea generation and final consensus voting which lasted for 2 h.
Results
Five individuals consented to participate. Of the 27 original ideas, 22 reached consensus including ones specifically related to a risk of harms statement: identifying risks and discomforts, identify different sensations, and using a classification to order risks by severity. Consensus was achieved with percent agreement of ≥ 80%. The constructed risk of harm statement had a reading level of grade 7 and provided a list of stratified risks associated with dry needling.
Conclusion
The generated risk of harm statement can be incorporated on IC forms that require disclosure of risks in both the clinical and research setting. Additionally, further elements were identified by panel participants about defining the framework for an IC form outside of the risk of harm statement.

Survey of Informed Consent Procedures in Urology: Disclosing Resident Participation to Patients
Eric A. Singer, Alexandra L. Tabakin, Arnav Srivastava, Labeeqa Khizir, Juliana E. Kim
Journal of Clinical Ethics, Summer 2023; 34(2) pp 190-195
Abstract
The American Urological Association (AUA) and American College of Surgeons (ACS) codes of professionalism require surgeons to disclose the specific roles and responsibilities of trainees to patients during the informed consent process. The objective of this study is to analyze how these requirements are met by urology training programs. An anonymous electronic survey was distributed to the program directors (PDs) of the 143 Accreditation Council for Graduate Medical Education urology residency programs in the United States in 2021. Information was collected regarding program demographics, aspects of the program’s consent process, and the disclosure to patients of the role and participation of residents in their surgery. There were 49 responses to the survey (34.3% response rate). Nearly 70 percent of PDs reported that attending physicians lead the consent process. The topics covered during consent discussion include possible complications (25%), expected recovery time (23%), length of the surgery (22%), the people involved (18%), and their specific roles (7%). Many PDs do not explicitly discuss trainee involvement (48.8%) or when a resident is to perform the majority of the case (87.8%). The majority of PDs (78.8%) communicate medical student involvement, but 73.2 percent reported having a patient decline participation of a trainee after describing their role. Despite the AUA and ACS codes of professionalism, many urologists do not disclose resident involvement in surgery to patients. Further discussions are needed to explore how to better balance resident education and patient autonomy.

Written Surgical Informed Consent Elements in Pediatric Differences of Sex Development: Pediatric Urologist and Endocrinologist Perspectives
Zoe K. Lapham,  Melissa Gardner, Sydney Sheinker,  Kristina I. Suorsa-Johnson, Barry A. Kogan, Peter A. Lee  David E. Sandberg
Frontiers in Urology, 2 June 2023
Abstract
Introduction
Elective aspects of surgical management of pediatric differences of sex development (DSD) are associated with controversy. We examined pediatric urologist and endocrinologist perspectives regarding recommended and existing informed consent elements for written consent documents prior to pediatric genital surgery.
Methods
Focus groups with pediatric urologist and endocrinologist members of the Societies for Pediatric Urology (SPU, n=8) or Pediatric Endocrine Society (PES, n=8) were held to identify elements of informed consent for DSD-related urogenital surgery. Elements were subsequently included in web-based surveys in 2003 and 2020 (SPU: n=121 and 143; PES: n=287 and 111, respectively). Participants rated their level of agreement with including each element in informed consent documents. In 2020, participants reported whether documents they use in clinical practice incorporate these elements.
Results
Groups identified four elements of informed consent: on-going debate over pediatric genital surgery; potential needs for multiple procedures; possible gender change and surgical reversal; and non-surgical alternatives. Across both years and both specialties, a majority (79% to 98%) endorsed the four elements, with significant between-group differences. Significantly more PES than SPU participants reported not knowing whether specific elements were included in current written informed consent; of those who knew, the majority (66% to 91%) reported inclusion.
Discussion
Specialists agree with including these four elements in written informed consent documents. Endocrinologists are not always familiar with the exact elements included. The degree to which non-surgeon members of the care team should be involved in the written informed consent process is an open question.

Surgical classification using natural language processing of informed consent forms in spine surgery
Michael D Shost, Seth M Meade, Michael P Steinmetz, Thomas E Mroz, Ghaith Habboub
Neurosurgical Focus, June 2023; 54(6)
Abstract
Objective
In clinical spine surgery research, manually reviewing surgical forms to categorize patients by their surgical characteristics is a crucial yet time-consuming task. Natural language processing (NLP) is a machine learning tool used to adaptively parse and categorize important features from text. These systems function by training on a large, labeled data set in which feature importance is learned prior to encountering a previously unseen data set. The authors aimed to design an NLP classifier for surgical information that can review consent forms and automatically classify patients by the surgical procedure performed.
Methods
Thirteen thousand two hundred sixty-eight patients who underwent 15,227 surgeries from January 1, 2012, to December 31, 2022, at a single institution were initially considered for inclusion. From these surgeries, 12,239 consent forms were classified based on the Current Procedural Terminology (CPT) code, categorizing them into 7 of the most frequently performed spine surgeries at this institution. This labeled data set was split 80%/20% into train and test subsets, respectively. The NLP classifier was then trained and the results demonstrated its performance on the test data set using CPT codes to determine accuracy.
Results
This NLP surgical classifier had an overall weighted accuracy rate of 91% for sorting consents into correct surgical categories. Anterior cervical discectomy and fusion had the highest positive predictive value (PPV; 96.8%), whereas lumbar microdiscectomy had the lowest PPV in the testing data (85.0%). Sensitivity was highest for lumbar laminectomy and fusion (96.7%) and lowest for the least common operation, cervical posterior foraminotomy (58.3%). Negative predictive value and specificity were > 95% for all surgical categories.
Conclusions
Utilizing NLP for text classification drastically improves the efficiency of classifying surgical procedures for research purposes. The ability to quickly classify surgical data can be significantly beneficial to institutions without a large database or substantial data review capabilities, as well as for trainees to track surgical experience, or practicing surgeons to evaluate and analyze their surgical volume. Additionally, the capability to quickly and accurately recognize the type of surgery will facilitate the extraction of new insights from the correlations between surgical interventions and patient outcomes. As the database of surgical information grows from this institution and others in spine surgery, the accuracy, usability, and applications of this model will continue to increase.

Exploring informed consent in midwifery care
Anna Madeley
British Journal of Midwifery, 31 May 2023; 31(6)
Abstract
One of the single most important tenets of healthcare ethics is that of informed consent. Situated in ethical, legal and human rights frameworks, informed consent at its core represents the ability to retain autonomy over one’s bodily integrity and to decide freely who can and cannot touch them. While consent at its simplest means being able to say yes or no, facilitating informed consent requires a more nuanced understanding of a dynamic process that, for midwives and other healthcare professionals, might seem challenging. The aim of this article is to provide a brief introduction to historical context and key legal cases that set the foundations for that which constitutes informed consent. This article focuses on what ‘informed’ means in relation to consent and, importantly, aims to dispel myths around receiving informed consent in contemporary midwifery practice.