Informed consent: perceptions and practice of orthopaedic trainees
Jodie Atkin, Ian W Incoll, John Owen, Chris Conyard
Australian and New Zealand journal of surgery, 4 February 2022
Abstract
Background
The purpose of informed consent is to provide patients with adequate information about a proposed plan or intervention, including the benefits and risks, so that they can make an informed decision about their medical treatment. The literature suggests that trainees are often delegated the task of obtaining consent with inadequate knowledge, skill or experience. The aim of this study is to determine the extent orthopaedic surgical trainees have been exposed to education about the informed consent, their perceived ability to obtain consent effectively and the frequency with which they routinely address elements of the process when consenting patients.
Methods
An eight-item questionnaire assessing trainees’ experience with informed consent was distributed to trainees undertaking Australian orthopaedic surgery training in 2019.
Results
Of the 239 trainees, 102 completed the questionnaire. Although 99% of trainees were confident that they can obtain valid consent from patients, when asked about aspects of the process, many trainees do not address them. Only 29% of trainees always ask patients about goals of care and 21% always advise the patient of who will be performing the procedure. Trainees who indicated that they had received education on informed consent during surgical training are significantly more likely to address key elements.
Conclusion
Trainees’ perceptions of their knowledge and skill in relation to informed consent does not align with their reported practice. Although the majority of trainees had received some education on informed consent, greater emphasis on explicit teaching and formal assessment should be undertaken during surgical training, prior to trainees completing this activity independently.
Year: 2022
Patient attitudes towards side effect information: An important foundation for the ethical discussion of the nocebo effect of informed consent
Patient attitudes towards side effect information: An important foundation for the ethical discussion of the nocebo effect of informed consent
Research Article
Mette Sieg, Lene Vase
Clinical Ethics, 1 February 2022
Abstract
A growing body of evidence suggests that the informed consent process, in which patients are warned about potential side effects of a treatment, can trigger a nocebo effect where expectations about side effects increase side effect occurrence. This has sparked an ethical debate about how much information patients ought to receive before a treatment while trying to balance the moral principles of patient autonomy and nonmaleficence. In keeping with the principle of patient autonomy, the opinion of patients themselves in relation to how much information they want about side effects is of utmost relevance in this debate. The literature was searched to identify surveys assessing patient attitudes towards side effect information. Across a broad variety of patient populations, treatment types, and countries, the majority of patients wished to be fully informed of potential side effects, particularly in relation to frequent and severe side effects, while only a small minority wanted minimal or no information at all. Results from this review suggest that nocebo research should focus on methods of avoiding nocebo effects of informed consent while ensuring that patients are well-informed about potential side effects.
Adults with capacity – a practical guide to gaining consent
Adults with capacity – a practical guide to gaining consent
Katie Crawley
Nature; BDJ Student, 31 January 2022; 29 pp 10
Introduction
Consent is an essential component of dentistry. Dental students often have very good theoretical knowledge of the consent process, but they may struggle to apply this knowledge practically within dental school. This article therefore presents a practical guide to obtaining valid consent from adults with capacity.
Living Kidney Donor Knowledge of Provided Information and Informed Consent: The PRINCE Study
Living Kidney Donor Knowledge of Provided Information and Informed Consent: The PRINCE Study
Article
Emerentia Q. W. Spoon, Kirsten Kortram, Sohal Y. Ismail, Daan Nieboer, Frank C. H. d’Ancona, Maarten H. L. Christiaans, Ruth E. Dam, Hendrik Sijbrand Hofker, Arjan W. J. Hoksbergen, Karlijn Ami van der Pant, Raechel J. Toorop, Jacqueline van de Wetering, Jan N. M. Ijzermans, Frank J. M. F. Dor
Journal of Clinical Medicine, 28 January 2022; 11(698)
Open Access
Abstract
Background
Informed consent for living kidney donation is paramount, as donors are healthy individuals undergoing surgery for the benefit of others. The informed consent process for living kidney donors is heterogenous, and the question concerns how well they are actually informed. Knowledge assessments, before and after donor education, can form the basis for a standardized informed consent procedure for live kidney donation.
Methods
In this prospective, a multicenter national cohort study conducted in all eight kidney transplant centers in The Netherlands, we assessed the current status of the informed consent practice for live donor nephrectomy. All of the potential living kidney donors in the participating centers were invited to participate. They completed a pop quiz during their first outpatient appointment (Cohort A). Living kidney donors completed the same pop quiz upon admission for donor nephrectomy (Cohort B).
Results
In total, 656 pop quizzes were completed (417 in Cohort A, and 239 in Cohort B). The average donor knowledge score was 7.0/25.0 (±3.9, range 0–18) in Cohort A, and 10.5/25.0 (±2.8, range 0–17.5) in Cohort B. Cohort B scored significantly higher on overall knowledge, preparedness, and the individual item scores (p < 0.0001), except for the long-term complications (p = 0.91).
Conclusions
Donor knowledge generally improves during the live donor workup, but it is still quite disappointing. Long-term complications, especially, deserve more attention during living kidney donor education.
Respecting Patient Autonomy: Voluntary Informed Consent in Modern Medicine
Respecting Patient Autonomy: Voluntary Informed Consent in Modern Medicine
Original Research
Grebenshchikova EG, Chuchalin AG
Medical Ethics, January 2021
Open Access
Abstract
The article reveals the most influential in modern bioethics approach to understanding voluntary informed consent as a way to implement the principle of respect for patient autonomy, which is determined by both legal regulation and socio-cultural factors. The authors discuss the main elements of informed consent, its specificity in clinical trials, and criteria for autonomous choice.
Types of Off-Label Drug Use and Informed Consent Doctrine When Prescribing Them
Types of Off-Label Drug Use and Informed Consent Doctrine When Prescribing Them
M. Drogovoz, V. M. Khomenko, V. V. Krynychko, M. Barus, A. Kovpak, M. O. Ostapets, T. O. Artiukh
Pharmacology Online, 2021; 3
Open Access
Abstract
Today, medicine does not have a sufficient arsenal of drugs for the personalized treatment of cancer, neurological, psychiatric, pediatric patients, HIV-infected patients. An important aspect of informed consent when prescribing drugs off label is informing patients about potentially unknown risks, as well as about the existence of a rationale for such prescription of the drug. Thus, the doctrine of informed consent means, on the one hand, the doctor provides the patient with complete information about the use of an off label drug, an alternative method of treatment, the risks and potential benefits of such an alternative, and on the other hand, the patient decides whether he is ready to be treated with a drug that will be used off label, and confirms this with informed consent. In modern good medical practice, the patient’s rights take precedence over the opinion of the medical practitioner. Informed consent is an integral component of the modern relationship between doctors and their patients and a means of ensuring that the doctor’s beliefs do not override the patient’s right to self-determination and personal integrity.
Consent [BOOK CHAPTER]
Consent [BOOK CHAPTER]
Kate McCombe
Quick Hits in Obstetric Anesthesia, 1 January 2022; pp 93-96 [Springer]
Abstract
Adult patients with capacity have absolute autonomy over their bodies and so we must seek valid consent before any medical intervention. Failing to gain consent risks criminal prosecution for battery (harmful or offensive contact with another person), a civil claim in medical negligence for financial compensation, and disciplinary action from the professional regulators e.g. the General Medical Council (GMC) in the UK.
Informed Consent: A Monthly Review
___________________________
February 2022
This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_February 2022
Medical research, data sharing, and properly informed consent
Medical research, data sharing, and properly informed consent
Notebook
Sheila M. Bird
Royal Statistical Society, 25 January 2022
Abstract
When Sheila M. Bird agreed to participate in a Covid surveillance study, she did not realise her negative test result and personal details would be passed to NHS Test and Trace. Here, she calls for closer scrutiny of privacy policies by research ethics committees, and clearer communication with study participants
Informed consent during pandemics: Experimental medicine, experienced consent
Informed consent during pandemics: Experimental medicine, experienced consent
M. Botes
South African Journal of Bioethics and Law, 2021; 14(3) pp 93-96
Abstract
No known cure exists for COVID-19, and medical practitioners are exhausted and at their wits’ end trying to find treatments that prevent patients from ending up in hospital or intensive care, or even dying. A variety of treatments tried by medical practitioners include standard registered medicine, investigational or so-called experimental, unapproved or preapproved medicines, emergency or compassionate-use authorised medicine and pre-market approved medicine. However, the medicines that can be accessed via each of these categories are at different stages of efficacy testing and knowledge about adverse effects, dosages and risks. To obtain ethical and legal informed consent, medical practitioners must deal with a lot of medical uncertainty, and care must be taken to ensure that the patient understands the difference in risks they may be willing to take depending on the medicine’s stage of development. Often additional information is required to obtain ethical consent as opposed to legal consent. A purely legal approach to informed consent, especially when dealing with the medical uncertainties of health emergencies and pandemics, may lead to patients’ consent lacking in enough substance to be truly considered legal and ethical. Informed consent as respect for autonomy in this sense requires more than the patient’s explicit agreement or compliance with a certain treatment proposal. This article explains the difference in consent content attached to each different stage of a medicine’s development, especially considering the additional difficulties posed by obtaining truly informed consent during a pandemic with uncertain characteristics, treatment and solutions.