Informed Consent in Italy—Traditional Versus the Law: A Gordian Knot

Turillazzi, Emanuela; Neri, Margherita; Riezzo, Irene; Frati, Paola; Fineschi, Vittorio

doi:10.1007/s00266-014-0337-z

Cited by 5 publications

(3 citation statements)

References 18 publications

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“…It would be an unforgivable error to allow the vaccination rates to decline below the critical percentages of herd immunity; it is probable that if this happens, VPD outbreaks will be serious enough to force governments to re-establish compulsoriness as in this case it would seem ethically justifiable [81]. This would constitute a double failure, considering on the one hand the morbidity and mortality that could otherwise be prevented and on the other the legal disregard of the individual's self-determination and freedom of choice [82]. On the contrary, the achievement of the programmed vaccination coverage following a non-compulsory administration would represent a win-win situation for the health of the community and the right to self-determination of each individual.…”

Section: Discussionmentioning

confidence: 99%

The Model of “Informed Refusal” for Vaccination: How to Fight against Anti-Vaccinationist Misinformation without Disregarding the Principle of Self-Determination

et al. 2021

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Vaccines are arguably a public health success story as well as an incredibly cost-effective medical resource. Despite this, worldwide concerns about their safety are growing, with the risk of increased morbidity and mortality in vaccine-preventable diseases because of vaccine refusal. The global political trend in developed countries is to increasingly reduce mandates and the compulsory nature of vaccination programs. This is due to strong opposition from anti-vaccination movements and groups. While these have existed since the beginnings of vaccinology, they have recently gained a strong foothold through massive exploitation of the media and especially the internet. This has led to widespread misinformation and greater difficulty for governments and health institutions in dealing with parents’ concerns and misconceptions. Common strategies in order to maintain a high degree of public acceptance of vaccines include the enhancement of adverse effect reporting systems, the enrichment of scientific literature, and the dissemination of targeted information to parents and health care providers. Vaccine risk perception, in fact, largely exceeds the evidence and is linked to well-known general population cognitive bias, which must be recognized and corrected. Although there is no doubt about the convenience of universal vaccination, a lively international debate is underway with regard to the legitimacy of mandatory vaccination programs. Most scientists agree that the individual’s right to self-determination should be preserved. The only way to simultaneously protect the right to health is to introduce an informed refusal model, which aims to guarantee the highest coverage rates for vaccination.

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Section: Discussionmentioning

confidence: 99%

The Model of “Informed Refusal” for Vaccination: How to Fight against Anti-Vaccinationist Misinformation without Disregarding the Principle of Self-Determination

et al. 2021

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“…Consequently, a gray area is identified in which the person does not own the right to choose to end his life, while maintaining those fundamental characteristics of dignity. Patient's chances would therefore be limited to the possibility of accelerating death through suspension of terminal care, when already experiencing late phases of illness and suffering (20,21).…”

Section: Discussionmentioning

confidence: 99%

European Countries' Different Legal Orientation About End-of-Life Issues in Patients Affected With Neurological/Psychiatric Diseases: Does Italian Law n.219/2017 Provide Adequate Options for This Fragile Category of Patients?

et al. 2021

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“…In the healthcare context, mental capacity is primarily based on the competence to complete informed consent regarding diagnostic and therapeutic procedures, to participate in research, and to establish advanced directives [3].…”

Section: Introductionmentioning

confidence: 99%

Capacity to Consent in Healthcare: A Systematic Review and Meta-Analysis Comparing Patients with Bipolar Disorders and Schizophrenia Spectrum Disorders

Morena,

Lippi,

Di Fazio

et al. 2024

Medicina

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Background: Mental capacity is a fundamental aspect that enables patients to fully participate in various healthcare procedures. To assist healthcare professionals (HCPs) in assessing patients’ capacity, especially in the mental health field, several standardized tools have been developed. These tools include the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), and the Competence Assessment Tool for Psychiatric Advance Directives (CAT-PAD). The core dimensions explored by these tools include Understanding, Appreciation, Reasoning, and Expression of a choice. Objective: This meta-analysis aimed to investigate potential differences in decision-making capacity within the healthcare context among groups of patients with bipolar disorders (BD) and schizophrenia spectrum disorders (SSD). Methods: A systematic search was conducted on Medline/Pubmed, and Scopus. Additionally, Google Scholar was manually inspected, and a manual search of emerging reviews and reference lists of the retrieved papers was performed. Eligible studies were specifically cross-sectional, utilizing standardized assessment tools, and involving patients diagnosed with BD and SSD. Data from the studies were independently extracted and pooled using random-effect models. Hedges’ g was used as a measure for outcomes. Results: Six studies were identified, with three studies using the MacCAT-CR, two studies the MacCAT-T, and one the CAT-PAD. The participants included 189 individuals with BD and 324 individuals with SSD. The meta-analysis revealed that patients with BD performed slightly better compared to patients with SSD, with the difference being statistically significant in the domain of Appreciation (ES = 0.23, 95% CI: 0.01 to 0.04, p = 0.037). There was no statistically significant difference between the two groups for Understanding (ES = 0.09, 95% CI:−0.10 to 0.27, p = 0.352), Reasoning (ES = 0.18, 95% CI: −0.12 to 0.47, p = 0.074), and Expression of a choice (ES = 0.23, 95% CI: −0.01 to 0.48, p = 0.60). In the sensitivity analysis, furthermore, when considering only studies involving patients in symptomatic remission, the difference for Appreciation also resulted in non-significant (ES = 0.21, 95% CI: −0.04 to 0.46, p = 0.102). Conclusions: These findings indicate that there are no significant differences between patients with BD and SSD during remission phases, while differences are minimal during acute phases. The usefulness of standardized assessment of capacity at any stage of the illness should be considered, both for diagnostic-therapeutic phases and for research and advance directives. Further studies are necessary to understand the reasons for the overlap in capacity between the two diagnostic categories compared in this study.

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Informed Consent in Italy—Traditional Versus the Law: A Gordian Knot

Abstract: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Cited by 5 publications

References 18 publications

The Model of “Informed Refusal” for Vaccination: How to Fight against Anti-Vaccinationist Misinformation without Disregarding the Principle of Self-Determination

The Model of “Informed Refusal” for Vaccination: How to Fight against Anti-Vaccinationist Misinformation without Disregarding the Principle of Self-Determination

European Countries' Different Legal Orientation About End-of-Life Issues in Patients Affected With Neurological/Psychiatric Diseases: Does Italian Law n.219/2017 Provide Adequate Options for This Fragile Category of Patients?

Capacity to Consent in Healthcare: A Systematic Review and Meta-Analysis Comparing Patients with Bipolar Disorders and Schizophrenia Spectrum Disorders

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