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.