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1.
Artigo em Alemão | MEDLINE | ID: mdl-34507381

RESUMO

Many surgical procedures are followed by postoperative pain. Acute pain should be treated optimally for medical and ethical reasons. Different psychological, physical, interventional and pharmacological methods are employed in a procedure specific and institution specific matter. For optimum patient care, implementation of acute pain management concepts in recommendations on quality management in German hospitals and outpatient clinics was enacted in September 2020 by Gemeinsamer Bundessausschuss (G-BA). Implementation of discharge management had already been enacted in 2017 for structured prescription of medication after hospital discharge, among other things. On the other hand, new national and international developments require a new weighting of pharmacotherapy in particular. Examples include debates on the safe use of metamizol and the opioid crisis in the US. To address these issues adjustments in informed consent and patient information and education are necessary. This includes also the information and education of caregivers. This article describes the legal framework, technical solutions and the impact of placebo and nocebo effects on doctor-patient communication.


Assuntos
Manejo da Dor , Alta do Paciente , Humanos , Consentimento Livre e Esclarecido , Dor Pós-Operatória/tratamento farmacológico , Relações Médico-Paciente
2.
Trials ; 22(1): 589, 2021 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-34479612

RESUMO

BACKGROUND: Deferred consent is used to recruit patients in emergency research, when informed consent cannot be obtained prior to enrolment. This model of consent allows studies to recruit larger numbers of participants, especially where a surrogate-decision maker may be unavailable to provide consent. Whilst deferred consent offers the potential to promote trial diversity by including under-served groups, it is ethically complex and views about its use amongst these populations require further exploration. The aim of this article is to build upon recent initiatives to improve inclusivity in trials, such as the NIHR INCLUDE project, and consider whether trials methodology research is inclusive, focusing on ethnic minority populations' attitudes towards the use of deferred consent. MAIN TEXT: Findings from the literature suggest that research regarding attitudes toward recruitment methods like deferred consent largely fail to adequately represent ethnic minorities. Many studies fail to report the composition of patient samples or conduct analyses on any differences between specific patient groups. In those that do, the categorisation of ethnic groups is ambiguous. Frequently diversely different groups are considered as more homogenous than they are. Whilst deferred consent is deemed generally acceptable, analysis of patient sub-groups shows that this attitude is not universal. Those from racial and ethnic minority backgrounds reported higher levels of unacceptability, which was impacted by previous first or second-hand experience of its use and historical mistrust in research. However, whilst deferred consent was found to increase the numbers of black participants enrolled in some trials, their over-enrolment in other trials may raise further concerns. CONCLUSIONS: Inclusivity in clinical trials is important, as highlighted by the COVID-19 pandemic. To improve this, we must ensure that methodological studies such as those exploring attitudes to research are inclusive. More effort is needed to understand the views of under-served groups, such as ethnic minorities, toward research in order to improve participation in clinical trials. Our findings echo those from the INCLUDE project, in that better reporting is needed and increasing the confidence of ethnic minority groups in research requires improving representation throughout the research process. This will involve diversifying research teams and ethics committees.


Assuntos
Ensaios Clínicos como Assunto , Grupos Étnicos , Consentimento Livre e Esclarecido , Grupos Minoritários , Seleção de Pacientes , COVID-19 , Humanos , Pandemias
3.
Exp Clin Transplant ; 19(8): 753-762, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34407747

RESUMO

Vaccines are among some of the most efficacious medical and public health methods ever employed to contain a pandemic, in addition to providing protective and preventive measures. Evaluation of vaccineassociated adverse events through experimentation and empirical evidence is an integral part ofthoroughly assessing the safety of vaccines before authorization of their widespread use. History has highlighted the importance of continuous search for possible vaccine-related adverse effects and vaccine-induced immunogenicity long afterlicensure, suggesting that a primary concern with new vaccines is not only efficacy but also safety, particularly overthe long term. Many of the various anti-COVID-19 vaccines have used different types of technology, with some being introduced for the first time or rushed shortly into testing, bypassing animal experimentations. They have been adopted for use through emergency use authorizations, leading to a less than optimal collection of broad data on safety, immunogenicity, effectiveness, and time span of protection, as well as short follow-up of few months, despite many infectious disease experts arguing thatit takes 10 years to develop a vaccine. Given the valid concerns on well-recognized short-term and long-term safety issues, such as antibody-dependent enhancement and other processes like molecular mimicry and potential genomic transformation, the experimental nature of the vaccination process, the limited shortterm follow-up in the main trials, and the dismissal by law of pharma companies and health care providers from any medico-legal responsibilities, the application of an informed consent should become not only a necessity but also mandatory by law in accordance with all declarations on human rights. Such information should be provided to every potential recipient in the form of an official written digital consent prior to the registration for or the receipt of the vaccine.


Assuntos
Vacinas contra COVID-19/uso terapêutico , COVID-19/prevenção & controle , Ensaios Clínicos como Assunto , Aprovação de Drogas , Consentimento Livre e Esclarecido , Vacinação , COVID-19/imunologia , COVID-19/virologia , Vacinas contra COVID-19/efeitos adversos , Humanos , Segurança do Paciente , Medição de Risco , Resultado do Tratamento , Vacinação/efeitos adversos
4.
BMC Med Ethics ; 22(1): 108, 2021 07 31.
Artigo em Inglês | MEDLINE | ID: mdl-34332572

RESUMO

BACKGROUND: The landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC. METHODS: Semi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method. RESULTS: Interviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States. CONCLUSIONS: Interviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research.


Assuntos
Consentimento Livre e Esclarecido , Projetos de Pesquisa , Comunicação , Eletrônica , Europa (Continente) , Humanos
6.
Trials ; 22(1): 541, 2021 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-34404466

RESUMO

BACKGROUND: In 1979, Marvin Zelen proposed a new design for randomized clinical trials intended to facilitate clinicians' and patients' participation. The defining innovation of Zelen's proposal was random assignment of treatment prior to patient or participant consent. Following randomization, a participant would receive information and asked to consent to the assigned treatment. METHODS: This narrative review examined recent examples of Zelen design trials evaluating clinical and public health interventions. RESULTS: Zelen designs have often been applied to questions regarding real-world treatment or intervention effects under conditions of incomplete adherence. Examples include evaluating outreach or engagement interventions (especially for stigmatized conditions), evaluating treatments for which benefit may vary according to participant motivation, and situations when assignment to a control or usual care condition might prompt a disappointment effect. Specific practical considerations determine whether a Zelen design is scientifically appropriate or practicable. Zelen design trials usually depend on identifying participants automatically from existing records rather than by advertising, referral, or active recruitment. Assessments of baseline or prognostic characteristics usually depend on available records data rather than research-specific assessments. Because investigators must consider how exposure to treatments or interventions might bias ascertainment of outcomes, assessment of outcomes from routinely created records is often necessary. A Zelen design requires a waiver of the usual requirement for informed consent prior to random assignment of treatment. The Revised Common Rule includes specific criteria for such a waiver, and those criteria are most often met for evaluation of a low-risk and potentially beneficial intervention added to usual care. Investigators and Institutional Review Boards must also consider whether the scientific or public health benefit of a Zelen design trial outweighs the autonomy interests of potential participants. Analysis of Zelen trials compares outcomes according to original assignment, regardless of any refusal to accept or participate in the assigned treatment. CONCLUSIONS: A Zelen design trial assesses the real-world consequences of a specific strategy to prompt or promote uptake of a specific treatment. While such trials are poorly suited to address explanatory or efficacy questions, they are often preferred for addressing pragmatic or policy questions.


Assuntos
Consentimento Livre e Esclarecido , Projetos de Pesquisa , Comitês de Ética em Pesquisa , Humanos
7.
Trials ; 22(1): 544, 2021 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-34407858

RESUMO

BACKGROUND: The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant's autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process. METHODS: Research staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically. RESULTS: Research participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources. CONCLUSIONS: Research participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques. TRIAL REGISTRATION: Not applicable.


Assuntos
Compreensão , Consentimento Livre e Esclarecido , Humanos , Irlanda , Pesquisa Qualitativa , Inquéritos e Questionários
9.
J Forensic Odontostomatol ; 2(39): 15-20, 2021 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-34419941

RESUMO

INTRODUCTION: The number of reported dental malpractice cases has increased in recent years. The aim of this study was to analyze the characteristics of Peruvian court sentences related to dental procedures. MATERIALS AND METHODS: In the present descriptive study, 33 sentences issued by the civil court of Peru, from 2011 to 2016 were collected. Useful information from the sentences was extracted and analyzed using the SPSS 18 software. RESULTS: Data showed that dentists were found guilty in 84.8% of sentences due to absence of suitability in dental treatment. Male dentists (61.1%) were involved in more cases than female dentists. Prosthodontics (33.3%) was the dental specialty subject to most claims. CONCLUSIONS: Dentists like other health professionals are regulated by legal rules in the country they practise. As part of dental practice and in order to avoid claims, having a full clinical history and informed consent should be mandatory.


Assuntos
Responsabilidade Legal , Imperícia , Odontólogos , Feminino , Humanos , Consentimento Livre e Esclarecido , Masculino , Peru
11.
Eur J Med Res ; 26(1): 87, 2021 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-34362461

RESUMO

BACKGROUND: COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2. METHODS: We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects. RESULTS: The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled. CONCLUSION: Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Consentimento Livre e Esclarecido/normas , Farmacovigilância , SARS-CoV-2/imunologia , Vacinação/normas , COVID-19/imunologia , COVID-19/virologia , Revelação , Humanos
12.
Ned Tijdschr Geneeskd ; 1652021 06 03.
Artigo em Holandês | MEDLINE | ID: mdl-34346617

RESUMO

Publishing a patient history or case report fulfills an important role in education and scientific research. However, this requires proper privacy protection. The main rule is that it must be nearly impossible to identify a patient in the presented case. If complete anonymity is not a possible, or if this is doubtful, publication is only possible after the patient's informed consent. But what if such authorization cannot be obtained, e.g. after a patient's death, or due to unknown whereabouts? In such a situation it should be possible to publish these cases, but only after careful consideration of all interests by authors and editorial board, possibly including opinions of the next of kin.


Assuntos
Consentimento Livre e Esclarecido , Privacidade , Humanos
13.
Ann R Coll Surg Engl ; 103(8): 615-620, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34464578

RESUMO

INTRODUCTION: The Future of Surgery report from the Royal College of Surgeons of England acknowledges the important role that three-dimensional imaging will play in support of personalised surgical interventions. One component of this is preoperative planning. We investigated surgeons' and patients' perceptions of this evolving technology. MATERIALS AND METHODS: Ethical approval was obtained. From a normal computed tomography scan, three-dimensional models of the stomach, pancreas and rectum were rendered and printed on an Ultimaker™ three-dimensional printer. Semi-structured interviews were performed with surgeons and patients to explore perceived model effectiveness and utility. Likert scales were used to grade responses (1 = strongly disagree; 10 = strongly agree) and qualitative responses recorded. RESULTS: A total of 26 surgeons (9 rectal, 9 oesophagogastric, 8 pancreatic) and 30 patients (median age 62 years, interquartile range, IQR, 68-72 years; 57% male) were recruited. Median surgeon scores were effectiveness for preoperative planning, 6 (IQR 3-7), authenticity, 5 (IQR 3-6), likability, 6 (IQR 4-7), promoting learning, 7 (IQR 5-8), utility, 6 (IQR 5-7) and helping patients, 7 (IQR 5-8). Median patient scores were usefulness to the surgeon, 8 (IQR 7-9), authenticity, 8 (IQR 6-8), likability, 8 (IQR 7-8), helping understanding of condition, 8 (IQR 8-9), helping understanding of surgery, 8 (IQR 7-9) and feeling uncomfortable, 1 (IQR 1-4). Median overall decisional conflict score (0 = no; 100 = high) was 22 (IQR 19-28) and decision effectiveness was 25 (IQR 19-30). DISCUSSION: Overall, patients and surgeons considered that three-dimensional printed models were effective and had potential utility in education and, to a lesser extent, preoperative planning. Patient decisional conflict and effectiveness scores were weighted towards certainty in decision making but had room for improvement, which three-dimensional models may help to facilitate.


Assuntos
Procedimentos Cirúrgicos do Sistema Digestório , Consentimento Livre e Esclarecido , Modelos Anatômicos , Cuidados Pré-Operatórios , Impressão Tridimensional , Idoso , Atitude do Pessoal de Saúde , Feminino , Neoplasias Gastrointestinais/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Pâncreas , Educação de Pacientes como Assunto , Reto , Estômago , Reino Unido
14.
Psychiatr Pol ; 55(3): 585-598, 2021 Jun 30.
Artigo em Inglês, Polonês | MEDLINE | ID: mdl-34460883

RESUMO

Within the scope of mental health protection, numerous practical problems arise concerning the issue of providing health services to a minor. Admission of a minor to a psychiatric hospital is associated in practice with numerous doubts. This part of the article describes the conditions of admission to hospital with the consent of the patient. It distinguishes and accurately describes situations where a minor is under or over 16 years of age. In addition, it explains situations where there is a contradiction of declarations of will by legal guardians in relation to admission, their inability to perform legal acts, or a contradiction of the statements of the minor and guardian. It also addresses the aspect of receiving written consent during the COVID-19 epidemic.


Assuntos
Internação Compulsória de Doente Mental/legislação & jurisprudência , Consentimento Livre e Esclarecido/legislação & jurisprudência , Tutores Legais/legislação & jurisprudência , Menores de Idade/legislação & jurisprudência , Admissão do Paciente/legislação & jurisprudência , Adolescente , COVID-19/epidemiologia , Hospitais Psiquiátricos/legislação & jurisprudência , Humanos , Transtornos Mentais/terapia , Polônia
15.
Artigo em Inglês | MEDLINE | ID: mdl-34360279

RESUMO

(1) Background: This study investigated parents' motives for enrolling preterm infants into music therapy intervention studies during Neonatal Intensive Care hospitalization. (2) Methods: We surveyed Israeli parents of preterm infants after they consented or refused to participate in such studies. The pre-piloted questionnaires evaluated attitudes toward research and music therapy intervention studies. The study included 116 (57%) parents who agreed to participate in music therapy studies and 87 (43%) who declined. (3) Results: Infants of those who agreed to participate were younger (17 ± 2.3 vs. 28 ± 4.7 days old, p = 0.03) and sicker (Clinical Risk Index for Babies score 6.1 ± 2.7 vs. 3.68 ± 4.1, p = 0.04). More single-parent families declined to participate (p = 0.05). Parents agreed to participate because they thought the study might help their child, would improve future care of preterm infants and increase medical knowledge (all p < 0.05). In addition, they perceived music as beneficial for brain development, thought it might improve bonding, and routinely listened to music daily. (4) Conclusions: When recruiting parents and preterm infants for music therapy intervention studies, one should highlight potential contributions to the child's health, future children's health and medical knowledge. Stressing music as a potential tool for brain development and augmenting bonding is important. The best time to recruit is when improvements are still anticipated.


Assuntos
Musicoterapia , Música , Atitude , Criança , Estudos Transversais , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Consentimento Livre e Esclarecido
16.
Artigo em Inglês | MEDLINE | ID: mdl-34360463

RESUMO

This study was conducted to evaluate the competency to consent to the treatment of psychiatric outpatients and to confirm the role of empowerment and emotional variables in the relationship between competency to consent to treatment and psychological well-being. The study participants consisted of 191 psychiatric outpatients who voluntarily consented to the study among psychiatric outpatients. As a result of competency to consent to treatment evaluation, the score of the psychiatric outpatient's consent to treatment was higher than the cut-off point for both the overall and sub-factors, confirming that they were overall good. In addition, the effect of the ability of application on psychological well-being among competency to consent to treatment was verified using PROCESS Macro, and the double mediation effect using empowerment and emotional variables was verified to provide an expanded understanding of this. As a result of the analysis, empowerment completely mediated the relation between the ability of application and psychological well-being, and the relation between the ability of application and psychological well-being was sequentially mediated by empowerment and emotion-related variables. Based on these findings, the implications and limitations of this study were discussed.


Assuntos
Emoções , Empoderamento , Humanos , Consentimento Livre e Esclarecido , Pacientes Ambulatoriais
17.
Artigo em Inglês | MEDLINE | ID: mdl-34360487

RESUMO

Background: Patients with advanced kidney disease have a symptomatic and psychological burden which warrant renal supportive care or palliative care. However, the impact of do-not-resuscitate consent type (signed by patients or surrogates) on end-of-life treatments in these patients remains unclear. Objective: We aim to identify influential factors correlated with different do-not-resuscitate consent types in patients with advanced kidney disease and the impact of do-not-resuscitate consent types on various life-prolonging treatments. Methods: This was a retrospective observational study. We included patients aged 20 years and over, diagnosed with advanced kidney disease and receiving palliative and hospice care consultation services between January 2014 and December 2018 in a tertiary teaching hospital in Taiwan. We reviewed medical records and used logistic regression to identify factors associated with do-not-resuscitate consent types and end-of-life treatments. Results: A total of 275 patients were included, in which 21% signed their do-not-resuscitate consents. A total of 233 patients were followed until death, and 32% of the decedents continued hemodialysis, 75% underwent nasogastric (NG) tube placement, and 70% took antibiotics in their final seven days of life. Do-not-resuscitate consents signed by patients were associated with reduced life-prolonging treatments including feeding tube placement and antibiotic use in the last seven days (odd ratio and 95% confidence interval were 0.16, 0.07-0.34 and 0.33, 0.16-0.69, respectively) compared to do-not-resuscitate consents signed by surrogates. Conclusions: Do-not-resuscitate consent signed by patients and not by surrogates may reflect better patients' autonomy and reduced life-prolonging treatments in the final seven days of patients with advanced kidney disease.


Assuntos
Cuidados Paliativos na Terminalidade da Vida , Nefropatias , Assistência Terminal , Humanos , Consentimento Livre e Esclarecido , Ordens quanto à Conduta (Ética Médica) , Estudos Retrospectivos
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