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 We included journal articles published in English and excluded non-peer-reviewed journal articles, unpublished manuscripts, and conference abstracts.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.

Blockchain innovation for consent self-management in health information exchanges
Chad Anderson, Arthur Carvalho, Mala Kaul, Jeffrey W. Merhout
Decision Support Systems, 30 May 2023
Abstract
With the increasing digitalization of health data, patients need to make informed decisions about the online sharing of their protected health information. This necessitates a robust technical infrastructure that enables patients to self-manage consent and the trusted exchange of this information across sharing entities. Unfortunately, current health information exchange systems in the U.S. are limited in both these regards. While there is recent work on digital patient consent management, there is limited work that provides effective solutions for patient self-management of consent. Further, interoperability issues in the way health information exchanges are currently architected and differences in regulations across localities exacerbate the challenges of consent management. In this research, we survey potential patients’ willingness to self-manage healthcare-related consent. Having established the desire for consent self-management, we propose a solution that enables the seamless sharing of patient consent across different healthcare providers and health information exchanges. Specifically, we use a rigorous design science approach to create a blockchain-based, self-managed patient consent system and we evaluate the design through an instantiated prototype. The results of our study should be useful to researchers in healthcare information management as well as to practitioners designing consent management systems. Our research contributes to design science research with an innovative, rigorously evaluated, design principles-based artifact that addresses a critical problem of sharing protected health information.

The evolution of informed consent in gastroenterology
Research Article
Fallon O’Neill, Parker O’Neill, Sierra Schaffer, Andrew Poullis
Medico-Legal Journal, 30 May 2023
Abstract
    With medical litigation on the rise, physicians require a nuanced understanding of the legalities of consenting patients to reduce their liability while practising evidence-based medicine. This study aims to a) clarify the legal duties of gastroenterologists in the UK and USA when gaining informed consent and b) provide recommendations at the international and physician level to improve the consent process and reduce liability.

A bibliometric analysis of the Web of Science database with the MeSH terms “gastroenterology” and “informed consent” yielded 383 articles, of which 228 were excluded due to not meeting the inclusion criteria. Of the top 50 articles, 48% were from American institutions and 16% were from the UK. Thematic analysis showed 72% of the articles discussed informed consent in relation to diagnostic procedures, 14% regarding treatment, and 14% regarding research participation.

Both the USA and the UK have progressed from previously paternalistic Natanson case (1960) and Bolam test (1957), respectively, where physicians were held to the standard of a “reasonable and prudent medical doctor”. The American Canterbury case (1972) and the British Montgomery case (2015) radically shifted the standard of disclosure during the consent process by requiring physicians to explain all information pertinent to a “reasonable patient”.

It is our recommendation that a two-pronged approach be taken; a) creation of international guidelines for consenting patients for invasive procedures in gastroenterology, and b) development of internationally standardised endoscopy consent forms containing all the details pertinent to a “reasonable patient”.