Informed Consent and Risk Management

Shah, Vidhi V.; Wolverton, Stephen E.; Kapp, Marshall B.

doi:10.1016/b978-0-323-61211-1.00068-1

Cited by 4 publications

(6 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Optimal care should be characterized by scientific discourse and inquiry, reliance on the highest levels of evidence, individualized care, and informed consent (Chow & Gallo et al, 2018;Madden & Bhandari, 2020;Shah & Turrin et al, 2021). Because COVID-19 is no longer a risk to the population at large, due to the arrival of less virulent strains like Omicron, or the latest B.2 variant, and due to widespread populationbased immunity, it is time to abandon such outdated vaccine mandates and return to solid medical practices and established standards of care.…”

Section: Discussionmentioning

confidence: 99%

Dispelling the Myth of a Pandemic of the Unvaccinated

McLeod¹,

Martins²,

Pelech³

et al. 2022

Vaccine Theory Prac & Res

View full text Add to dashboard Cite

We have reanalyzed the Ontario Science Table data on hospitalizations for COVID-19 in COVID-19 vaccinated versus unvaccinated patients admitted to hospital during various waves of the pandemic. In spite of the Ontario Science Table and the mass media claims that the unvaccinated were the dominant population being hospitalized, a more rigorous evaluation of the existing data shows that this narrative is not correct for the latter waves of COVID-19. We identify a series of methodological issues that may have led to their conclusions and why such issues may have resulted in policies that have been largely ineffective.

show abstract

Section: Discussionmentioning

confidence: 99%

Dispelling the Myth of a Pandemic of the Unvaccinated

McLeod¹,

Martins²,

Pelech³

et al. 2022

Vaccine Theory Prac & Res

View full text Add to dashboard Cite

show abstract

“…There is already a deficit in providing the necessary information to patients. 5 This is in part due to the already-existing barriers clinicians encounter when communicating with patients, which include time constraints. 39 Many practitioners maintain that obtaining informed consent every time ML is used is very time consuming and could take up time from the conversation about care.…”

Section: Practical Considerationsmentioning

confidence: 99%

“…The practitioner informs the patient, in a simple and understandable language, about the procedure and associated risks and benefits, possible alternatives, prognosis, and consequences of each clinical decision. [4][5][6] It is difficult to define the details of what ought to be disclosed; generally, clinicians need to disclose everything that a reasonable patient would want and need to know to understand their clinical situation and consequentially make an informed decision. 5,[7][8][9] However, this rule is very broad-what matters varies depending on the case-and can still result in paternalism since it is the clinician who decides which information is indispensable.…”

Section: Introductionmentioning

confidence: 99%

“…[4][5][6] It is difficult to define the details of what ought to be disclosed; generally, clinicians need to disclose everything that a reasonable patient would want and need to know to understand their clinical situation and consequentially make an informed decision. 5,[7][8][9] However, this rule is very broad-what matters varies depending on the case-and can still result in paternalism since it is the clinician who decides which information is indispensable. 10 This highlights the asymmetry of power and information between doctors and their patients.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Machine learning applications in healthcare and the role of informed consent: Ethical and practical considerations

et al. 2022

View full text Add to dashboard Cite

Informed consent is at the core of the clinical relationship. With the introduction of machine learning (ML) in healthcare, the role of informed consent is challenged. This paper addresses the issue of whether patients must be informed about medical ML applications and asked for consent. It aims to expose the discrepancy between ethical and practical considerations, while arguing that this polarization is a false dichotomy: in reality, ethics is applied to specific contexts and situations. Bridging this gap and considering the whole picture is essential for advancing the debate. In the light of the possible future developments of the situation and the technologies, as well as the benefits that informed consent for ML can bring to shared decision-making, the present analysis concludes that it is necessary to prepare the ground for a possible future requirement of informed consent for medical ML.

show abstract

“… 5 As not all stroke patients are able to consent to IVT, the treating physicians are forced to evaluate the presumed will of the patient and to obtain patients’ informed consent. 6 – 8 According to German law (BGB §630e), the Mental Capacity Act 2005 in UK and the principle of informed consent in the United States, 9 the treating physician is obliged to inform the patient on type, scope, implementation, expected consequences, and risks of the medical measure as well as its necessity, urgency, suitability, and prospects of success, which regularly prolongs the door-to-needle time. 10 Also in line with German law, the US emergency doctrine of implied consent and the guidelines of the American Medical Association/American Stroke Association, the treating physician is not obliged to obtain the patient’s consent in emergency situations before a medical intervention, if the intervention cannot be postponed.…”

Section: Introductionmentioning

confidence: 99%

Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study

Schuster

Essig

Daneshkhah

et al. 2023

European Stroke Journal

View full text Add to dashboard Cite

Introduction: Intravenous thrombolysis (IVT) is an on label treatment for selected patients with acute ischemic stroke (AIS). As major bleeding or allergic shock may occur, the need to ensure patients’ informed consent for IVT is a matter of debate. Patients and methods: Prospective investigator-initiated multi-center observational study to assess the ability of AIS patients to recall information, provided by a physician during a standardized educational talk (SET) on IVT use. The recall of 20 pre-defined items was assessed in AIS after 60–90 min ( n = 93) or 23–25 h ( n = 40) after SET. About 40 patients with subacute stroke, 40 non-stroke patients, and 23 relatives of AIS patients served as controls, and were surveyed 60–90 min after SET. Results: Within 60–90 min after SET, AIS patients (median age 70 years, 31% female, median NIHSS score on admission 3 points) who were considered capable to provide informed consent recalled 55% (IQR 40%–66.7%) of the provided SET items. In multivariable linear regression analysis recapitulation by AIS patients was associated with their educational level (β = 6.497, p < 0.001), self-reported excitement level (β = 1.879, p = 0.011) and NIHSS score on admission (β = −1.186, p = 0.001). Patients with subacute stroke (70 years, 40% female, median NIHSS = 2) recalled 70% (IQR 55.7%–83.6%), non-stroke patients (75 years, 40% female) 70% (IQR 60%–78.7%), and AIS relatives (58 years, 83% female) 70% (IQR 60%–85%). Compared to subacute stroke patients, AIS patients less often recalled the frequency of IVT-related bleeding (21% vs 43%), allergic shock (15% vs 39%), and bleeding-related morbidity and mortality (44% vs 78%). AIS patients recalled 50% (IQR 42.3%–67.5%) of the provided items 23–25 h after SET. Conclusion: AIS patients eligible for IVT remember about half of all SET-items after 60–90 min or 23–25 h, respectively. The fact that the recapitulation of IVT-associated risks is particularly poor should be given special consideration.

show abstract

Informed Consent and Risk Management

Cited by 4 publications

References 21 publications

Dispelling the Myth of a Pandemic of the Unvaccinated

Dispelling the Myth of a Pandemic of the Unvaccinated

Machine learning applications in healthcare and the role of informed consent: Ethical and practical considerations

Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study

Contact Info

Product

Resources

About