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Trials Jan 2021Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and... (Review)
Review
BACKGROUND
Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients' comprehension of an informed consent's basic components shows that their level of understanding is limited.
METHODS
Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients' comprehension of specific informed consent components.
RESULTS
In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators' blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects.
CONCLUSIONS
We found that participants' comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients' full and genuine involvement in a shared medical decision-making process.
Topics: Comprehension; Humans; Informed Consent
PubMed: 33446265
DOI: 10.1186/s13063-020-04969-w -
Orthopaedics & Traumatology, Surgery &... Feb 2021Patient information is now an ethical and legal obligation in France; it is the physician who is required to provide proof. The Law of March 4, 2002 and the code of... (Review)
Review
Patient information is now an ethical and legal obligation in France; it is the physician who is required to provide proof. The Law of March 4, 2002 and the code of ethics and main legal and regulatory texts are, however, imprecise on some points. Written documents, although not stipulated in law, are in practice essential, supplementing the indispensable oral information given by the surgeon in individual personalized interview. Patients remember only some of this information, and overestimate their own understanding of it. Written documents are therefore essential to compensate for this. Their contents need validation by scientific societies. In case of disagreement, the medical file is the essential means of assessing information quality, and should be kept up to date as rigorously as possible. A key document is the letter summarizing the preoperative consultation, validating surgery, which should be drawn up in a manner that meets the obligation to inform. Signed consent is not mandatory in law, but is necessary in practice and should be archived. For judges, proof of information is based on several elements: the complete structured letter to the patient and community physician plus the signed information sheet and consent form constitute solid evidence and all three should be included in the medical file. Information has now become a part of health-care in itself. In a context of increasing litigation, "defensive medicine" is still to be avoided but physicians should have their own check-lists so as to be in a position to prove delivery of structured information if called upon to do so. In the absence of proven information, patients can plead loss of chance and/or prejudice for lack of preparation and/or infringement of dignity, and claim damages from the courts.
Topics: France; Humans; Informed Consent
PubMed: 33321239
DOI: 10.1016/j.otsr.2020.102771 -
British Dental Journal Jan 2021
Topics: Disclosure; Informed Consent
PubMed: 33483636
DOI: 10.1038/s41415-021-2614-y -
Frontiers in Public Health 2022We describe relevant interfaces between law and psychiatry and current ethical and legal views and changes within the past decades. Ideas of patient autonomy and...
We describe relevant interfaces between law and psychiatry and current ethical and legal views and changes within the past decades. Ideas of patient autonomy and patients' rights have been major drivers of changes in legal frameworks. We describe developments in the areas of patient information and informed consent, involuntary placement and involuntary treatment, use of coercive measures, forensic psychiatry, digital mental health, data privacy, physician liability, suicide, assisted suicide, euthanasia, end of life decision-making, advance directives, legal and illegal drugs, and delegation and substitution of professional activities. There is no unidirectional pathway between law and ethics. Views, conflicts, and requirements differ between countries and within countries and will need to be balanced according to the societies' changing values also in the future.
Topics: Advance Directives; Humans; Informed Consent; Mental Health; Physicians; Psychiatry
PubMed: 36091517
DOI: 10.3389/fpubh.2022.968168 -
Family Medicine Jan 2023
Topics: Humans; Clothing; Informed Consent
PubMed: 36656890
DOI: 10.22454/FamMed.55.410985 -
Revista Da Escola de Enfermagem Da U S P 2021To synthesize current evidence on nurses' attitudes and/or knowledge on the entire spectrum of patient rights.
OBJECTIVE
To synthesize current evidence on nurses' attitudes and/or knowledge on the entire spectrum of patient rights.
METHOD
A systematic search of the literature was performed in Web of Science, PubMed, Scopus and CINAHL. Studies were selected according to pre-defined inclusion/exclusion criteria. The Cochrane and PRISMA guidelines, including templates for systematic reviews, were applied. For rigor assessment, the Critical Appraisal Skills Program Qualitative Research Checklist, and the Center for Evidence-Based Management tool were employed.
RESULTS
Thirteen studies were included, that exhibited important methodological limitations, such as convenience sampling, mediocre response rates and inadequate instrument validity. Findings indicated: a) low level of awareness regarding patient rights among nurses, b) knowledge discrepancies on specific aspects of patient rights, c) low priority ascribed to a patient's right to access information, and d) insufficient evidence on formal educational sources of knowledge on the topic of patient rights.
CONCLUSION
Narrow geographical localization, heterogeneity and methodological limitations render generalizability of the conclusions difficult. Further research based on robust methodology is proposed.
Topics: Attitude; Humans; Nurses; Patient Rights; Qualitative Research
PubMed: 33825782
DOI: 10.1590/S1980-220X2019037603678 -
Ugeskrift For Laeger Feb 2021Decentralised clinical trials are a modification of traditional clinical trials, which make studies cost-effective, time-saving and easier for participants. The use of... (Review)
Review
Decentralised clinical trials are a modification of traditional clinical trials, which make studies cost-effective, time-saving and easier for participants. The use of digital solutions and health technologies in part or the entire trial process from patient recruitment, participant information, obtaining informed consent, clinical site visits, trial procedures, sampling, medication administration and safety monitoring enables for more effective conduct of the trial. Collecting data from multiple digital platforms allows for better and continuous monitoring of trial participants. In this review, we summarise those points.
Topics: Humans; Informed Consent; Patient Selection
PubMed: 33660601
DOI: No ID Found -
The Lancet. Digital Health Jun 2023Fuelled by adaptations to clinical trial implementation during the COVID-19 pandemic, decentralised clinical trials are burgeoning. Decentralised clinical trials involve... (Review)
Review
Fuelled by adaptations to clinical trial implementation during the COVID-19 pandemic, decentralised clinical trials are burgeoning. Decentralised clinical trials involve many digital tools to facilitate research without physical contact between research teams and participants at various stages, such as recruitment, enrolment, informed consent, administering study interventions, obtaining patient-reported outcome measures, and safety monitoring. These tools can provide ways of ensuring participants' safety and research integrity, while sometimes reducing participant burden and trial cost. Research sponsors and investigators are interested in expanding the use of decentralised clinical trials. The US Food and Drug Administration and other regulators worldwide have issued guidance on how to implement such adaptations. However, there has been little focus on the distinct ethical challenges these trials pose. In this Health Policy report, which is informed by both traditional research ethics and digital ethics frameworks, we group the related ethical issues under three areas requiring increased ethical vigilance: participants' safety and rights, scientific validity, and ethics oversight. Our aim is to describe these issues, offer practical means of addressing them, and prompt the delineation of ethical standards for decentralised trials.
Topics: Humans; Pandemics; COVID-19; Informed Consent; Ethics, Research; Research Personnel
PubMed: 37105800
DOI: 10.1016/S2589-7500(23)00052-3 -
American Journal of Public Health Feb 2022
Topics: Humans; Vaccination; Vaccination Hesitancy; Vaccination Refusal
PubMed: 35080931
DOI: 10.2105/AJPH.2021.306636 -
Arquivos de Neuro-psiquiatria 2019Patients with epilepsy face innumerable obstacles in daily life, related to work, permission to drive and interpersonal relationships, which require medical guidance.... (Review)
Review
Patients with epilepsy face innumerable obstacles in daily life, related to work, permission to drive and interpersonal relationships, which require medical guidance. This paper reports a literature review based on scientific articles and civil and traffic system, as a way to resolve doubts about medical obligations in the patient's permission to drive and work. An employment agreement requires the contractor to guarantee safety conditions as well as requiring the patient, at the pre-employment medical examination, to let the physician know previous medical conditions, including epilepsy. More than 90% of patients with epilepsy omit this information during the application assessment, thus being subject to imputation of ideological falsehood crime as disposied on article 299 of Brazilian Penal Code. Medical confidentiality breaches may only occur in specific situations. In Brazil, the authorization and driver's license renewal is governed by the Brazilian Traffic Code (Federal Law n° 9503/1997). For patient evaluations, two groups are considered: those on antiepileptic medication and those on medication withdrawal. A favorable report from the attending physician is also required, in both categories. Seizures that occur exclusively during sleep, and focal aware events or prolonged aura are not differentiated from other seizure types disposed in the traffic law. It is the responsibility of the attending physician to analyze each patient individually to resolve conflicts between public safety and the individual patient's independence. A frank and honest doctor-patient relationship is essential for the patient to understand the public and individual consequences of epileptic seizures and to feel comfortable seeking medical help.
Topics: Automobile Driving; Brazil; Epilepsy; Ethics, Medical; Humans; Neurologists; Patient Rights; Right to Work
PubMed: 31664350
DOI: 10.1590/0004-282X20190133