Practice variation in the informed consent procedure for thrombolysis in acute ischemic stroke: a survey among neurologists and neurology residents
Research
Valentijn J. Zonjee, Jos P. L. Slenders, Frank de Beer, Marieke C. Visser, Bastiaan C. ter Meulen, Renske M. Van den Berg-Vos, Sander M. van Schaik
BMC Medical Ethics, 25 August 2021; 22(114)
Open Access
Abstract
Background
Obtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical practice. This study examines the procedure of informed consent for intravenous thrombolysis in acute ischemic stroke in high-volume stroke centers in the Netherlands.
Methods
In four high volume stroke centers, neurology residents and attending neurologists received an online questionnaire concerning informed consent for thrombolysis with tissue-type plasminogen activator (tPA). The respondents were asked to report their usual informed consent practice for tPA treatment and their considerations on whether informed consent should be obtained.
Results
From the 203 invited clinicians, 50% (n = 101) completed the questionnaire. One-third of the neurology residents (n = 21) and 21% of the neurologists (n = 8) reported that they always obtain informed consent for tPA treatment. If a patient is not capable of providing informed consent, 30% of the residents (n = 19) reported that they start tPA treatment without informed consent. In these circumstances, 53% of the neurologists (n = 20) reported that the resident under their supervision would start tPA treatment without informed consent. Most neurologists (n = 21; 55%) and neurology residents (n = 45; 72%) obtained informed consent within one minute. None of the respondents used more than five minutes for informed consent. Important themes regarding obtaining informed consent for treatment were patients’ capacity, and medical, ethical and legal considerations.
Conclusion
The current practice of informed consent for thrombolysis in acute ischemic stroke varies among neurologists and neurology residents. If informed consent is obtained, most clinicians stated to obtain informed consent within one minute. In the future, a shortened information provision process may be applied, making a shift from informed consent to informed refusal, while still considering the patient’s capacity, stroke severity, and possible treatment delays.
Month: September 2021
A Critical Appraisal of Variability in Informed Consent for Vascular Access Procedures
A Critical Appraisal of Variability in Informed Consent for Vascular Access Procedures
Research Article
Blake Hotchkiss, Judy Thompson
Journal of the Association for Vascular Access, 18 August 2021
Abstract
Background
Vascular access device insertion is one of the most performed procedures in healthcare today. With different device types available to provide infusion therapy, there are many different variables to consider, including the process of obtaining informed consent from patients. This literature review aims to discuss common themes present in current evidence-based practice and point out critical areas of variability that exist.
Methods
A literature review was conducted searching Cochrane Library, Joanna Briggs Institute for Evidence-Based Practice, Cumulative Index to Nursing and Allied Health Literature, PubMed, and Google Scholar databases for recently published articles in the English language and those written in English. Articles were screened to include those that describe informed consent within the context of vascular access or other invasive procedures. There were 35 articles and 5 systematic reviews identified that met criteria for inclusion in this literature review.
Discussion
The topics of ethics, legal responsibility, who provided consent, and how education about procedures was performed demonstrated clear insight into how to improve the consent process. Some areas in current evidence lack clear direction and create variability in the informed consent procedure. These included who should obtain consent from the patient and which vascular access devices required a written consent. Who obtains consent was found to be more related to current legal precedence and not the clinician inserting the device like that found when a nonphysician clinician performed the procedure. Vascular access device related variability in requiring written versus verbal consent was found to be rooted in the degree of complexity of the procedure, need for specialized training, and the inherent risk to the patient.
Conclusion
These two areas of variability described in current clinical practice require more research and consensus agreement to standardize the practice of obtaining informed consent in vascular access device insertion.
Does radiology require informed consent for radiation risk?
Does radiology require informed consent for radiation risk?
Commentary
Elizabeth M Davies, Andrew J Bridges, Emma ML Chung
The British Institute of Radiology, 6 August 2021
Abstract
Recent trends in medical decision-making have moved from paternalistic doctor-patient relations to shared decision-making. Informed consent is fundamental to this process and to ensuring patients’ ongoing trust in the health-care profession. It cannot be assumed that patients consent to the risk associated with medical exposures, unless they have been provided with the information to make that decision. This position is supported by both the legal and ethical framework around Radiation Protection detailed in this commentary.
Are patients truly informed? A retrospective chart review of the documentation of informed consent in laparoscopic cholecystectomy
Are patients truly informed? A retrospective chart review of the documentation of informed consent in laparoscopic cholecystectomy
Erin Williams, Raj Selvam, Wilma Hopman, Sulaiman Nanji
Canadian Journal of Surgery, 29 July 2021; 64(4)
Abstract
Background
Research on informed consent (IC) has traditionally focused on the documentation of the discussion with patients of potential complications. We sought to examine the completeness of documentation for all elements of IC for laparoscopic cholecystectomy (LC): potential complications, alternatives to LC and details of the procedure. Differences in the documentation of IC for elective and emergent LC were examined.
Methods
A retrospective chart review of patients undergoing LC at our institution between 2015 and 2017 was performed. Completeness of documentation was defined as documentation of all 3 elements of IC in the clinic note, the operating room note or the consent form itself. Data were analyzed descriptively. We compared documention for emergent and elective cases as well as documentation by residents and attending physicians using t tests.
Results
A total of 270 patients were included in the analysis. Only 5 (2%) had complete documentation of all elements of IC. Documentation of potential complications was noted in 232 cases (86%), of which 58 (25%) were elective and 174 (75%) were emergent. Details were noted in 28 (10%) cases, of which 21 (75%) were elective and 7 (25%) were emergent. Alternatives were documented the least frequently: they were documented in 23 cases (9%), of which 20 (87%) were elective and 3 (13%) were emergent. Residents performed better than attending physicians in documenting IC discussions in clinic notes and on consent forms, but not in operating room notes.
Conclusion
Documentation of the elements of IC for LC was poor. Potential complications were the most frequently documented element of IC; alternatives and details were often omitted. Future studies comparing audiotaped IC conversations with the documentation of IC are warranted. The use of procedure-specific consent forms for LC may facilitate documentation.
Soft Tissue Filler Therapy and Informed Consent – A Canadian Review
Soft Tissue Filler Therapy and Informed Consent – A Canadian Review
Review Article
John P. Arlette, Andrea L. Froese, Jaspreet K. Singh
Journal of Cutaneous Medicine and Surgery, 26 July 2021
Abstract
Soft Tissue Filler (STF) Therapy for cosmetic facial rejuvenation is associated with known complications. The manifestation of these known complications can lead to patients commencing civil litigation actions or making complaints to provincial regulatory authorities and alleging that the practitioner failed to obtain the patient’s informed consent to the therapy. Data provided by the Canadian Medical Protective Association (CMPA) on medical-legal cases arising from the provision of STF therapy between 2005 and 2019 are presented. Select reported case law decisions from Canadian courts and regulatory bodies addressing the concept of informed consent are reviewed. Insights about the risk factors pertaining to the process of obtaining informed consent for STF therapy are presented to increase an understanding of the elements of communication and documentation needed to ensure patients are aware of the consequences of this treatment.
An Evaluation of the Comprehensibility Levels of Ophthalmology Surgical Consent Forms
An Evaluation of the Comprehensibility Levels of Ophthalmology Surgical Consent Forms
Original Article
Ibrahim Ethem Ay, Mustafa Doğan
Cureus, 26 July 2021
Abstract
Background/Aim
This study aimed to evaluate the comprehensibility of the consent forms used for interventional procedures in the ophthalmology clinic of a university hospital and to determine which texts could be read according to patient age and education level.
Materials and methods
Forty separate consent forms used as the standard for various interventional procedures in the ophthalmology department of a university hospital were evaluated. The comprehensibility formulas used were developed for the Turkish language by Ateşman and Bezirci-Yilmaz.
Results
As a result of the evaluation of the consent forms in this study, a mean of 55.6±5.73 points was obtained according to the Ateşman comprehensibility index, and this value was found to correspond to being understood by eleventh and twelfth-grade school students. According to the Bezirci-Yilmaz comprehensibility index, the mean points of the consent forms were 10.05±2, which corresponded to a level that could be understood by 10th and 11th-grade students.
Conclusion
The comprehensibility level of the consent forms given to patients was found to be low in this study, which was similar to the findings of previous studies in the literature. When preparing informed consent forms, the education level of the country must be taken into consideration.
Does the General Medical Council’s 2020 guidance on consent advance on its 2008 guidance?
Does the General Medical Council’s 2020 guidance on consent advance on its 2008 guidance?
Clinical Ethicsz
Abeezar I Sarela
Journal of Medical Ethics, 23 August 2021
Abstract
The General Medical Council renewed its guidance on consent in 2020. In this essay, I argue that the 2020 guidance does not advance on the earlier, 2008 guidance in regard to treatments that doctors are obliged to offer to patients. In both, doctors are instructed to not provide treatments that are not in the overall benefit, or clinical interests, of the patient; although, patients are absolutely entitled to decline treatment. As such, consent has two aspects, and different standards apply to each aspect. To explore this paradigm, I propose the reconceptualisation of consent as a person’s freedom to achieve treatment, using Amartya Sen’s approach. Sen explains that freedom has two aspects: process and opportunity. Accordingly, a patient’s freedom to achieve treatment would comprise a process for the identification of proper treatment, followed by an opportunity for the patient to accept or decline this treatment. As per Sen, the opportunity aspect is to be assessed by the standard of public reason, whereas the standard for the process aspect is variable and contingent on the task at hand. I then use this reconceptualised view of consent to analyse case law. I show that senior judges have conceived the patient’s opportunity to be encompassed in information, which is to be decided by public reason. On the other hand, the process aspect relies on the private reason of medical professionals. Given the nature of professionalism, this reliance is inescapable, and it is maintained in the case law that is cited in both guidances.
Consent is an organizational behavior issue
Consent is an organizational behavior issue
Vanessa K.Bohns, RachelSchlund
Research in Organizational Behavior, 18 August 2021
Abstract
Consent is central to many organizational interactions and obligations. Employees consent to various terms of employment, both formal (contractual obligations) and informal (extra-role responsibilities, interpersonal requests). Yet consent has traditionally been considered a legal matter, unrelated to organizational behavior. In this article, we make a case for why, and how, organizational behavior scholars should undertake the study of consent. We first review scholarship on the legal understanding of consent. We argue that the traditional legal understanding is an incomplete way to think about consent in organizations, and we call for a more nuanced understanding that incorporates psychological and philosophical insights about consent—particularly consent in employer-employee relationships. We then connect this understanding of consent to traditional organizational behavior topics (autonomy, fairness, and trust) and examine these connections within three organizational domains (employee surveillance, excessive work demands, and sexual harassment). We conclude with future directions for research on consent in organizations.
ICME: an informed consent management engine for conformance in smart building environments [CONFERENCE PAPER]
ICME: an informed consent management engine for conformance in smart building environments [CONFERENCE PAPER]
Chehara Pathmabandu, John Grundy, Mohan Baruwal Chhetri, Zubair Baig
ESEC/FSE 2021: Proceedings of the 29th ACM Joint Meeting on European Software Engineering Conference and Symposium on the Foundations of Software Engineering, August 2021; pp 1545–1549
Open Access
Abstract
Smart buildings can reveal highly sensitive insights about their inhabitants and expose them to new privacy threats and vulnerabilities. Yet, convenience overrides privacy concerns and most people remain ignorant about this issue. We propose a novel Informed Consent Management Engine (ICME) that aims to: (a) increase users’ awareness about privacy issues and data collection practices in their smart building environments, (b) provide fine-grained visibility into privacy conformance and infringement by these devices, (c) recommend and visualise corrective user actions through “digital nudging”, and (d) support the monitoring and management of personal data disclosure in a shared space. We present a reference architecture for ICME that can be used by software engineers to implement diverse end-user consent management solutions for smart buildings. We also provide a proof-of-concept prototype to demonstrate how the ICME approach works in a shared smart workplace. Demo: <a>https://youtu.be/5y6CdyWAdgY</a>
Communication and Libertarianism [BOOK]
Communication and Libertarianism [BOOK]
Pavel Slutskiy
Springer, 3 August 2021
Editor’s note: In Communication and libertarianism, which covers a range of themes, the four chapters below were relevant to consent.
Communicating Consent
Abstract
The libertarian non-aggression principle rests on two concepts: the concept of property rights, which defines the borders of individual autonomy, and the concept of consent, which defines unwarranted intrusion. Both concepts depend on communication—borders of property need to be publicly manifested on the one hand, and consent needs to be expressed in order to exist in the reality of human action on the other. Unless consent is manifested, it remains hypothetical, and hypothetical consent is never valid. Even if an action based on hypothetical consent coincides with the preferences of the consent-giver, it happens to be so only by coincidence. Counting on such hypothetical consent is risky, and the actor who takes the risk bears full responsibility for potential mistakes which may lead to uninvited interference. Hypothetical consent needs to be separated from tacit and implied consent, both of which can be valid. Internal “mental” aspects of consent may be important felicity conditions for consent, but they are not enough for a successful performance of the act of consenting. It is “external” or expressive aspects of consenting which are crucial for making the preferences of the consent-giver identifiable to another agent, thus changing the status of his actions. Only communicated consent is capable of performing the “magic” of making actions permissible, and only communicated consent can be used by actors to defend against potential accusations in rights violation.
Communication Ethics: Consent as the Foundation of Non-aggression
Abstract
One of the major challenges for political philosophy is the postulated impossibility of building a sound theory without a solid foundation in ethics. Ethical questions of what is good and what is bad arise within the context of social interactions—in relation to actions unto other people. But judgements on what is good and what is bad are necessarily subjective. This, however, does not mean that this subjective judgement is not true. Man’s opinion about what is a bad action unto him is a correct evaluation of the action in question. For an acting agent, the opinion of the action’s recipient is thus the source of the correct ethical assessment of the action. This assessment can only become known to the acting agent by the means of communication. Communicating a subjective value judgement on what is good and what is bad gives the other agent knowledge about the ethical value of the intended action. Acting unto another man against his consent thus implies wrongdoing.
Manipulation of Consent
Abstract
This chapter examines several criticisms of non-fraudulent commercial speech. According to critics, even if business propaganda does not constitute fraud by intentionally misleading consumers, it still may be illegitimate for other reasons. Advertising is accused of coercion through manipulative persuasion, exaggeration and puffery. Other charges include accusations of promoting products and services that are harmful for consumers who therefore later regret purchasing them, and this regret invalidates the consent given at the moment of making the purchase. These accusations are examined from the property rights perspective as well from the communication perspective.
The Role of Property Rights in the Ethics of Consent
Abstract
Consent is what allows us to tell others whether their actions unto us are acceptable from our point of view. Proceeding with an action without our consent, or after consent has been refused, would constitute a moral wrongdoing. However, consent is only required for giving moral evaluation to actions that are directed towards other actors and affect them. An action can be considered as intended towards another person if it interferes with this person’s “zones of control”—borders of physical objects with which one creates a particular relationship. This relationship is ownership—it assumes that any hindrance to the use of the object without the consent of the owner is a wrongdoing. Ownership comes from the direct control of bodies, and original appropriation of external objects and voluntary transfers forms the foundation of property rights—violation against property is a violation against the owner. A legal system based on the idea that property rights violations constitute an offence recognises the validity of the non-aggression principle. The non-aggression principle prohibits the initiation of force, which is understood as an action of border crossing without the owner’s consent. The concept of consent and the concept of borders are ontologically based on communication, which means that communication is the basis of the non-aggression principle.
Center for Informed Consent Integrity 