Informed Consent for Anterior Lumbar Access Surgery
Book Chapter
Steven E. Raper
Lumbar Spine Access Surgery, 21 February 2024 [Springer]
Abstract
Informed consent is a keystone of the surgeon-patient relationship rooted in the ethical principles of autonomy and beneficence. Many stakeholders (e.g., healthcare institutions, legislators, the courts, state and federal regulators, and professional societies) contribute to an informed consent process in constant evolution. Informed consent also remains important for patients undergoing spine access and spine surgery. Many of the material risks have been identified. Patients need to be told if their surgery will overlap with that of another. Medical malpractice lawsuits often allege lack of consent against neurosurgeons and orthopedic surgeons who perform spine surgery. Novel approaches are ongoing in the effort to improve the process of informed consent. Elements of social justice should be considered in spine access and spinal operations to ensure all patients can give fully informed consent. This chapter will touch upon all these elements of the informed consent process.

Quantifying the Effect of Consent for High–Kidney Donor Profile Index Deceased Donor Transplants in the United States
Jesse D. Schold, Kendra D. Conzen, James Cooper, Susana Arrigain, Rocio Lopez, Sumit Mohan, S. Ali Husain, Anne M. Huml, Peter T. Kennealey, Bruce Kaplan, Elizabeth A. Pomfret
Journal of the American Society of Nephrology, 13 February 2024
Abstract
Background
Despite known benefits of kidney transplantation, including transplantation from donors with increased risk factors, many waitlisted candidates die prior to transplantation. Consent to receive donor kidneys with lower expected survival (e.g. kidney donor profile index [KDPI]>85%) is typically obtained at waitlist placement. The presumed benefit of consent to receive high-KDPI donor kidneys is increased likelihood and timeliness of donor offers for transplantation. However, the specific impact of consent on access to transplantation is unclear. Our aims were to evaluate the characteristics of candidates consenting to high-KDPI donor kidneys and the likelihood of receiving a deceased donor transplant (DDTX) over time based on consent.
Methods
We used national Scientific Registry of Transplant Recipients data between 2015 and 2022(n=213,364). We evaluated the likelihood of consent using multivariable logistic models and time to DDTX with cumulative incidence plots accounting for competing risks and multivariable Cox models.
Results
Overall, high-KDPI consent was 41%, which was higher among candidates who were older, Black or Hispanic, had higher BMI, were diabetic, had vascular disease, and 12-48 months pre-listing dialysis time, with significant center-level variation. High-KDPI consent was associated with higher rates of DDTX(Adjusted Hazard Ratio=1.15,95% Confidence Interval=1.13,1.17) with no difference in likelihood of DDTX from donors with KDPI<85%. The effect of high-KDPI consent on higher rates of DDTx was higher among candidates ages >60 years and diabetic candidates and variable based on center characteristics.
Conclusions
There is significant variation of consent for high-KDPI donor kidneys and higher likelihood of transplantation associated with consent.

Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital
José Manuel García-Álvarez, Alfonso García-Sánchez
Nursing Reports, 4 January 2024; 14(1) pp 89-98
Abstract
Background
Because of their direct and continuous contact with the patient, nurses play a relevant role in ensuring that informed consent forms are complete and easy to read and comprehend. The objective of this study was to analyze the legibility and formal quality of informed consent forms for non-surgical procedures in a county hospital.
Methods
The readability of these forms was analyzed using the INFLESZ scale and the information they provided according to the formal quality criteria established for these forms.
Results
Readability was difficult in 78.08% of the forms analyzed. No form fulfilled all the criteria, the most non-compliant being the non-appearance of the verification of delivery of a copy to the patient (100%), the contraindications (94.59%), and the alternatives (83.78%) of the procedure. Statistically significant differences were observed between disciplines with respect to the INFLESZ readability score and the formal quality score, but no statistically significant correlation was found between the two scores.
Conclusions
The informed consent forms for non-surgical procedures analyzed presented mostly difficult readability and poor formal quality, making it difficult for patients to have understandable and complete information. Nursing professionals should be actively involved in their improvement to facilitate patient decision making.

A Pilot Study On The Global Practice On Informed Consent In Paediatric Dentistry
Original Research
Nicoline Potgieter, Gemma Bridge, Marlies Elfrink, Morenike O. Folayan, Sherry Shiqian Gao,  Sonia Groisman, Ashwin Jawdekar, Arthur M. Kemoli, David Lim, Phuong Ly, Shani Mani, Ray M. Masumo, Joana Monteiro, Majorie K. Muasya, Ambrina Qureshi, Norman Tinanoff
Frontiers in Oral Health, 2024
Abstract
Background
Conducting oral treatment early in the disease course is encouraged for better health outcomes. Obtaining informed consent is an essential part of medical practice, protecting the legal rights of patients and guiding the ethical practice of medicine. In practice, consent means different things in different contexts. Silver Diamine Fluoride (SDF) and Silver Fluoride (SF) are becoming popular and cost-effective methods to manage carious lesions, however, cause black discolouration of lesions treated. Obtaining informed consent and assent is crucial for any dental treatment and has specific relevance with SDF/ SF treatments.
Methods
The aim of this paper is to describe informed consent regulations for dental care in a selection of countries, focusing on children and patients with special healthcare needs. An online survey was shared with a convenience sample of dental professionals from 13 countries. The information was explored and the processes of consent were compared.
Results
Findings suggest that there are variations in terms of informed consent for medical practice. In Tanzania, South Africa, India, Kenya, Malaysia and Brazil age is the determining factor for competence and the ability to give self-consent. In other countries, other factors are considered alongside age. For example, in Singapore, the United Kingdom, and the United States the principle of Gillick Competence is applied. Many countries’ laws and regulations do not specify when a dentist may overrule general consent to act in the “best interest” of the patient.
Conclusion
It is recommended that it is clarified globally when a dentist may act in the “best interest” of the patient, and that guidance is produced to indicate what constitutes a dental emergency. The insights gathered provide insights on international practice of obtaining informed consent and to identify areas for change, to more efficient and ethical treatment for children and patients with special needs. A larger follow up study is recommended to include more or all countries.

Implementing co-production to enhance patient safety: the introduction of the Patient Safety Consent tool, an example of a simple local solution to a common challenge
Abdulelah Alhawsawi, David Greenfield
International Journal for Quality in Health Care, 28 December 2023
Abstract
Zero harm is one of the priorities that all healthcare systems are aspiring for. However, more than two decades after ‘To Err is Human’ report, many systems are struggling to identify or implement strategies to achieve this important goal. One of the very powerful, yet underutilized strategies towards transforming patient safety and achieving Zero Harm is ‘co–production’. Co-production of health is defined as ‘the interdependent work of users and professionals who are creating, designing, producing, delivering, assessing, and evaluating the relationships and actions that contribute to the health of individuals and populations’. Simply put, co-production means that patients contribute alongside professionals to the provision of health services. While we know the importance and potential value of co-production, many health systems are underutilizing the approach. Actions to effectively implement and sustain changes to service provision to use co-production are elusive. To realize improvements, a key requirement for health professionals is addressing the question: how can we implement and sustain co-production in efficient, effective ways? To address this challenge, and thereby improve patient safety and work towards zero harm, we introduce the ‘Patient Safety Consent’ (PSC) tool, a simple co-production tool to empower patients and families to become more active members in their own healthcare. Implementing the co-production of care, requires a shift in the traditional attitudes and power dynamics between healthcare professionals and patients. Professionals explicitly share service information, diagnosis assessments, treatment options, decision-making and involve patients and their families in determining the direction and actions for their care; conversely, patients and families take on an active role in engaging in discussions, potential care pathways, and ongoing decisions about their treatment and care. Hence, the PSC tool is a direct, engaging, comprehensive and, where used effectively, a powerful strategy for changing the dynamics and outcomes of care…

Probability and informed consent
Book Chapter
Nir Ben-Moshe, Benjamin A. Levinstein, Jonathan Livengood
Theoretical Medicine and Bioethics, 8 August 2023 [Springer]
Abstract
In this paper, we illustrate some serious difficulties involved in conveying information about uncertain risks and securing informed consent for risky interventions in a clinical setting. We argue that in order to secure informed consent for a medical intervention, physicians often need to do more than report a bare, numerical probability value. When probabilities are given, securing informed consent generally requires communicating how probability expressions are to be interpreted and communicating something about the quality and quantity of the evidence for the probabilities reported. Patients may also require guidance on how probability claims may or may not be relevant to their decisions, and physicians should be ready to help patients understand these issues.

Patients’ Information before invasive coronary procedures, when signing a written consent is challenging!
Kallel, O. Haddar, Y. Mallek, W. Abbes, H. Denguir, H. Barhoumi, H. Ben Ahmed
Archives of Cardiovascular Diseases, January 2024
Abstract
Introduction
Despite the progress in Invasive coronary procedures, patients‘ anxiety is still of concern. This anxiety may compromise adherence to the exam and the signature of the written consent. This latter is a relatively emergent culture to the Tunisian patient. We noticed a discordance in patients attitude expressing oral consent and reticent to sign a written one.
Objective
We investigated the role of standardized oral information in reducing anxiety of patients before invasive coronary procedures, improving knowledge and signing written consent rate.
Method
We conducted an experimental randomized, prospective study including patients scheduled for coronary artery procedures over 4 weeks. The intervention consisted in a standardized oral information. We compared the level of anxiety, the level of knowledge and the rate of written consent’s signature, before and after the intervention. Information was conducted by either a doctor or a nurse according to coin tossing randomization. Anxiety was measured with Visual analogical scale (VAS), and the State Anxiety Inventory (STAI-S). Knowledge was assessed via 10 yes or No questions about coronary artery procedure (utility, access route, X rays, Contrast solution injection, stent implantation, possible outcomes). Were excluded, patients with emergent procedures and patients that refused to participate.
Results
We included 39 patients, males in 89.7% of cases, mean age was 64.5 ± 7.8 ans. Clinical presentation was a stabilized acute coronary artery syndrome in 92.3% of cases. Patients were illiterates in 23.1%, with low instructive level in 46.2% of cases. In their history, patients were asked to sign a written consent in only 2.6% of cases. Level of anxiety evaluated via VAS was significantly improved (2.91/10 before, 2.47/10 after, p = 0.041). there was no significant difference according to STAI-S score (44.44 before, 44.85 after, p = 0.39). Level of information get better (2.94/10 before, 7.71/10 after, p < 0.0001). The rate of written consent ‘signature improved significantly from 41% to 76% (p < 0.004). There was no difference between nurse and doctor in proceeding to oral information and asking for signing the written consent (73.9% with nurse versus 86.6% with doctor, p = 0.44)
Conclusion
Oral standardized information helped to improve level of knowledge of patients ongoing non emergent invasive coronary procedures, to reduce anxiety and to get a better adherence to exam attested by the signature of the written consent. Other types of information, especially with audio-visual support, may be more efficient and need to be tested.

Parturients feel capable of giving informed consent for epidural analgesia: A qualitative and quantitative analysis
Oliver Bastian Christoffersen, Ann Merete Møller, Laerke Vinberg Moestrup, Kim Wildgaard
Scandinavian Society of Anaesthesiology and Intensive Care Medicine, 27 December 2023
Abstract
Introduction
The patient’s right to autonomy confirmed by informed consent is a cornerstone in modern medicine. Epidural analgesia is increasingly popular in obstetric analgesia, but physicians disagree whether labour pain impairs parturient decision-making. We investigated the fraction of parturients feeling capable of giving informed consent including their knowledge of risks.
Methods
Bedside survey postpartum women at the Herlev Hospital, Denmark. The inclusion criteria were recipient of epidural analgesia during labour. A power calculation based on the recognition of genuine and false side effects required the inclusion of 50 participants.
Results
Forty out of fifty (80%) of the participants felt they could make a judicious consent during labour and 46 out of 50 (92%) felt they knew enough about epidural analgesia to give consent to the procedure again if necessary. Participants spontaneously reported a median of two risks associated with epidural analgesia. Additionally, when prompted with a cued list of true and false risks from epidural analgesia, the participants reported on average 5.1 genuine risks compared with 0.4 made-up risks. The difference (4.7) suggests the included women could discern genuine risks from made-up risks.
Discussion
The majority of participants reported the capacity to give informed consent. Our quantitative results show the participants could clearly distinguish genuine risks of epidural labour analgesia from made-up risks. Our qualitative data likewise suggest that participants understood the information and consequently their informed consent was genuine. Accordingly, parturients are able to give informed consent. This is supported by parturients’ ability to identify risks from epidural labour analgesia.

Should Obtaining Informed Consent Be Considered an Entrustable Professional Activity? Insights From Whether and How Attendings Entrust Surgical Trainees
Research Report
Erin M. White, Andrew C. Esposito, Peter S. Yoo
Academic Medicine, 19 December 2023
Abstract
Purpose
Because residents are frequently delegated the task of obtaining consent early in their training, the American Association of Medical Colleges describes “obtaining informed consent” as a core entrustable professional activity (EPA) for medical school graduates. However, prior studies demonstrated that residents frequently perform this task without receiving formal instruction or assessment of competency. This study sought to understand how attending physicians decide to delegate obtaining informed consent for surgical procedures to trainees.
Method
The authors conducted a survey of attending surgeons at a university-based health care system of 6 affiliated teaching hospitals (October–December 2020) to collect data about current entrustment practices and attendings’ knowledge, experience, and attitudes surrounding the informed consent process. Summary statistics and bivariate analyses were applied.
Results
Eighty-five attending surgeons participated (response rate, 49.4%) from diverse specialties, practice types, and years in practice. Fifty-eight of 85 (68.2%) stated they “never” granted responsibility for the consent conversation to a trainee and 74/81 (91.4%) reported they typically repeated their own consent conversation whenever a trainee already obtained consent. The most common reasons they retained responsibility for consent were ethical duty (69/82, 84.1%) and the patient relationship (65/82, 79.3%), while less than half (40/82, 48.8%) described concerns about trainee competency. Reflecting on hypothetical clinical scenarios, increased resident competency did not correspond with increased entrustment (P = 0.27 – 0.62). Nearly all respondents (83/85, 97.7%) believed residents should receive formal training, however, only 41/85 (48.2%) felt additional training and assessment of residents might change their current entrustment practices.
Conclusions
Attendings view informed consent as an ethical and professional obligation that typically cannot be entrusted to trainees. This practice is discordant with previous literature studying residents’ perspectives. Furthermore, resident competency does not play a predominant role in this decision, calling into question whether informed consent can be considered an EPA.

Informed Written Consent for Emergency and Elective General Surgery at a Model 4 Hospital: A Closed-Loop Audit
Ke En Oh, Nikhil Vasandani, Afiq Anwar, Babak Meshkat
Cureus, 27 November 2023; 15(11)
Abstract
Introduction
The objective of this investigation was to conduct an audit of the consent form standards signed by patients before elective or emergency general surgery at our institution. The investigation involved a comparison of these standards with those outlined in the “HSE National Consent Policy 2022” established by the Health Service Executive (HSE) and the Royal College of Surgeons in Ireland (RCSI). In the event of discrepancies, we intended to complete the audit loop by educating general surgeons on the essential standards for obtaining written consent in both elective and emergency general surgical procedures.
Methods
To assess the quality of patient consent, a pre-interventional phase was conducted over one week. Information was gathered exclusively through electronic medical record systems. Subsequent to the data analysis, an in-person educational session was conducted to enlighten non-consultant hospital doctors (NCHDs) in surgery about the significance of informed written consent and the criteria for lawful consent according to local guidelines established by the HSE and the RCSI. Three months following the intervention, a follow-up cycle was carried out to evaluate whether there were any improvements in the standards of consent.
Results
In the initial phase, prior to intervention, a total of 95 consent forms were collected. The patient’s name, date of birth (DOB), and hospital board number (BN) were accurately recorded in all consent forms. However, only 66% (n=63) were accurately documented without the use of abbreviations or acronyms. Following the intervention, 145 consent forms were gathered. All appropriately indicated the patient’s name, DOB, and BN. However, 84% (n=122) of consent forms were correctly labeled without the use of abbreviations or acronyms (p=0.0017).
Conclusion
This closed-loop review illustrates that the quality of consent can be notably enhanced through a straightforward educational intervention led by NCHDs in general surgery. Such interventions can be instructive, leading to improved consent form documentation. This, in turn, enhances patient safety and helps prevent potential medico-legal repercussions for both healthcare providers and institutions.