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5.
PLoS One ; 16(9): e0256697, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34469482

RESUMO

BACKGROUND: The Mental Capacity Act (MCA, 2005) and its accompanying Code of Practice (2007), govern research participation for adults with capacity and communication difficulties in England and Wales. We conducted a systematic review and narrative synthesis to investigate the application of these provisions from 2007 to 2019. METHODS AND FINDINGS: We included studies with mental capacity in their criteria, involving participants aged 16 years and above, with capacity-affecting conditions and conducted in England and Wales after the implementation of the MCA. Clinical trials of medicines were excluded. We searched seven databases: Academic Search Complete, ASSIA, MEDLINE, CINAHL, PsycArticles, PsycINFO and Science Direct. We used narrative synthesis to report our results. Our review follows Preferred Reporting Items for Systematic Reviews and is registered on PROSPERO, CRD42020195652. 28 studies of various research designs met our eligibility criteria: 14 (50.0%) were quantitative, 12 (42.9%) qualitative and 2 (7.1%) mixed methods. Included participants were adults with intellectual disabilities (n = 12), dementia (n = 9), mental health disorders (n = 2), autism (n = 3) and aphasia after stroke (n = 2). We found no studies involving adults with acquired brain injury. Diverse strategies were used in the recruitment of adults with capacity and communication difficulties with seven studies excluding individuals deemed to lack capacity. CONCLUSIONS: We found relatively few studies including adults with capacity and communication difficulties with existing regulations interpreted variably. Limited use of consultees and exclusions on the basis of capacity and communication difficulties indicate that this group continue to be under-represented in research. If health and social interventions are to be effective for this population, they need to be included in primary research. The use of strategic adaptations and accommodations during the recruitment process, may serve to support their inclusion.


Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Deficiência Intelectual/psicologia , Seleção de Pacientes , Projetos de Pesquisa/estatística & dados numéricos , Consentimento do Representante Legal/estatística & dados numéricos , Adulto , Ensaios Clínicos como Assunto/legislação & jurisprudência , Tomada de Decisões , Inglaterra , Humanos , Deficiência Intelectual/terapia , Projetos de Pesquisa/legislação & jurisprudência , Consentimento do Representante Legal/legislação & jurisprudência , País de Gales
7.
J Am Heart Assoc ; 10(17): e020609, 2021 09 07.
Artigo em Inglês | MEDLINE | ID: mdl-34459246

RESUMO

Background Long-term outcomes of percutaneous coronary intervention (PCI) based on patients' decision-making ability have not been studied. Our objective was to assess long-term outcomes after PCI in patients who provided individual versus surrogate consent. Methods and Results Data were collected retrospectively for patients who underwent PCI at Cleveland Clinic between January 1, 2015 and December 31, 2016. Inclusion criteria consisted of hospitalized patients aged ≥20 years who had PCI. Patients with outpatient PCI, or major surgery 30 days before or 90 days after PCI, were excluded. Patients who underwent PCI with surrogate consent versus individual consent were matched using the propensity analysis. Kaplan-Meier, log rank, t-statistic, and χ2 tests were used for statistical analysis. The study was approved by the Institutional Review Board at Cleveland Clinic, Ohio. Of 3136 patients who underwent PCI during the study period, 183 had surrogate consent. Propensity matching yielded 149 patients from each group. Two-year all-cause mortality was significantly higher in the surrogate consent group (38 [25.5%] versus 16 [10.7%] deaths, log-rank χ2=10.16, P<0.001). The 2-year major adverse cardiac events rate was also significantly higher in the surrogate consent group (60 versus 36 events, log-rank χ2=8.36, P=0.003). Conclusions Patients with surrogate consent had significantly higher all-cause mortality and higher major adverse cardiac events when compared with patients with individual consent. This study emphasizes the fact that patients with an inability to give consent are at high risk and may need special attention in postprocedural and postdischarge care.


Assuntos
Doença da Artéria Coronariana , Tomada de Decisões , Intervenção Coronária Percutânea , Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Humanos , Consentimento Livre e Esclarecido , Estimativa de Kaplan-Meier , Intervenção Coronária Percutânea/efeitos adversos , Estudos Retrospectivos , Fatores de Risco , Consentimento do Representante Legal , Resultado do Tratamento
9.
Reprod Health ; 18(1): 82, 2021 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-33874969

RESUMO

BACKGROUND: Supportive male involvement is strongly correlated with contraceptive use. In Rwanda, where the contraceptive prevalence rate among married women increased from 17 to 52% from 2005 to 2010, and stagnated at 53% in 2015, understanding the role of male partners in collaborative couple contraceptive use can help inform programs designed to further increase the use of contraception in Rwanda. METHODS: This study utilized qualitative methods in 2018, specifically 32 in-depth interviewers with mostly current users of modern contraceptive methods and eight focus group discussions with family planning providers-both family planning nurses and community health workers (CHWs). Respondents were from Musanze and Nyamasheke Districts, the districts with the highest and lowest modern contraceptive use, respectively, to explore the role of couple collaboration in family planning use in Rwanda. Data were analyzed using the thematic content approach in Atlas.ti (8). RESULTS: Findings demonstrate that some men are opposed to use of male methods of contraception, and some are opposed to any contraceptive use, which can lead to covert use. Women and providers prefer collaborative couple contraceptive use-as a result, providers advocate for and encourage male partner participation in contraceptive use. Women are most often burdened with seeking out information, initiating discussions, and sharing information discovered about contraceptive use with partners. Decision-making about contraceptive use, once discussed, can be collaborative and motivated by financial considerations. When couple contraceptive use is collaborative, benefits range from marital harmony to husband's support of sustained use through reminders about appointments, joint counseling, and support in managing side effects. CONCLUSION: Family planning providers at the community and clinic levels encourage collaborative contraceptive use among couples and some Rwandan couples communicate well about family planning use. Despite the positives, women are expected to source family planning information, share that information with their male partners, seek out family planning services, and use family planning. If more Rwandan male partners accepted use, used male methods of contraception, and participated even more in the work it takes to use family planning, the potential for sustained, and even enhanced, contraceptive use in Rwanda could be realized.


Assuntos
Comportamento Contraceptivo , Anticoncepção/estatística & dados numéricos , Serviços de Planejamento Familiar , Cônjuges/psicologia , Comunicação , Comportamento Cooperativo , Feminino , Humanos , Entrevistas como Assunto , Masculino , Ruanda , Consentimento do Representante Legal , Adulto Jovem
10.
Hastings Cent Rep ; 51(2): 16-21, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33840101

RESUMO

Harrowing stories reported in the media describe Covid-19 ravaging through families. This essay reports professional experiences of this phenomenon, family clustering, as encountered during the pandemic's spread across Southern California. We identify three ethical challenges following from it: Family clustering impedes shared decision-making by reducing available surrogate decision-makers for incapacitated patients, increases the emotional burdens of surrogate decision-makers, and exacerbates health disparities for and the suffering of people of color at increased likelihood of experiencing family clustering. We propose that, in response to these challenges, efforts in advance care planning be expanded, emotional support offered to surrogates and family members be increased, more robust state guidance be issued on ethical decision-making for unrepresented patients, ethics consultation be increased in the setting of conflict following from family clustering dynamics, and health care professionals pay more attention to systemic and personal racial biases and inequities that affect patient care and the surrogate experience.


Assuntos
Planejamento Antecipado de Cuidados , COVID-19/epidemiologia , Saúde da Família , Família/psicologia , Saúde das Minorias , Assistência ao Paciente , Planejamento Antecipado de Cuidados/ética , Planejamento Antecipado de Cuidados/legislação & jurisprudência , California/epidemiologia , Análise por Conglomerados , Tomada de Decisão Compartilhada , Saúde da Família/ética , Saúde da Família/etnologia , Disparidades nos Níveis de Saúde , Humanos , Saúde das Minorias/ética , Saúde das Minorias/etnologia , Assistência ao Paciente/ética , Assistência ao Paciente/psicologia , SARS-CoV-2 , Apoio Social , Consentimento do Representante Legal/ética
12.
Arch Dis Child Fetal Neonatal Ed ; 106(3): 244-250, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33139313

RESUMO

BACKGROUND: More effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form. OBJECTIVE: To explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials. METHODS: A qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis. SETTING: Eleven neonatal units in England. PARTICIPANTS: Eleven parents and ten health professionals with experience of simplified consent. RESULTS: Five themes emerged: 'opt-out consent operationalised as verbal opt-in consent', 'opt-out consent normalises participation while preserving parental choice', 'opt-out consent as an ongoing process of informed choice', 'consent without a consent form' and 'choosing to opt out of a comparative effectiveness trial', with two subthemes: 'wanting "normal care"' and 'a belief that feeding is better'. CONCLUSION: Introducing a novel form of consent proved challenging in practice. The principle of a simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as 'opt-out' can help to normalise participation and emphasise that parents can withdraw consent.


Assuntos
Atitude do Pessoal de Saúde , Nutrição Enteral/métodos , Enterocolite Necrosante/terapia , Pais , Seleção de Pacientes/ética , Suspensão de Tratamento , Adulto , Atitude Frente a Saúde , Feminino , Humanos , Recém-Nascido , Cuidados para Prolongar a Vida/métodos , Masculino , Neonatologia/ética , Neonatologia/métodos , Pais/educação , Pais/psicologia , Pesquisa Qualitativa , Consentimento do Representante Legal
13.
Arch Dis Child Fetal Neonatal Ed ; 106(3): 258-264, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33127737

RESUMO

OBJECTIVE: To evaluate the opinions of parents of newborns following their infant's enrolment into a neonatal research study through the process of deferred consent. DESIGN: Mixed-methods, observational study, interviewing 100 parents recently approached for deferred consent. SETTING: Tertiary-level neonatal intensive care unit, Melbourne, Australia. RESULTS: All 100 parents interviewed had consented to the study/studies using deferred consent; 62% had also experienced a prospective neonatal consent process. Eighty-nine per cent were 'satisfied' with the deferred consent process. The most common reason given for consenting was 'to help future babies'. Negative comments regarding deferred consent mostly related to the timing of the consent approach, and some related to a perceived loss of parental rights. A deferred approach was preferred by 51%, 24% preferred a prospective approach and 25% were unsure. Those who thought prospective consent would not have been preferable cited impaired decision-making, inappropriate timing of an approach before birth and their preference for removal of the decision-making burden via deferred consent. Seventy-seven per cent thought they would have given the same response if approached prospectively; those who would have declined reported that a prospective approach under stressful conditions was unwelcome and too overwhelming. CONCLUSION: In our sample, 89% of parents of infants enrolled in neonatal research using deferred consent considered it acceptable and half would not have preferred prospective consent. The ability to make a more considered decision under less stressful circumstances was key to the acceptability of deferred consent.


Assuntos
Pesquisa Biomédica , Termos de Consentimento , Pesquisa sobre Serviços de Saúde , Neonatologia/métodos , Pais/psicologia , Consentimento do Representante Legal/ética , Adulto , Austrália , Pesquisa Biomédica/ética , Pesquisa Biomédica/métodos , Feminino , Pesquisa sobre Serviços de Saúde/ética , Pesquisa sobre Serviços de Saúde/métodos , Humanos , Recém-Nascido , Masculino , Seleção de Pacientes , Pesquisa Qualitativa , Percepção Social/psicologia , Fatores de Tempo
14.
Bioethics ; 35(3): 255-261, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33078429

RESUMO

Community engagement is increasingly defended as an ethical requirement for biomedical research. Some forms of community engagement involve asking the consent of community leaders prior to seeking informed consent from community members. Although community consent does not replace individual consent, it could problematically restrict the autonomy of community members by precluding them from research when community leaders withhold their permission. Community consent is therefore at odds with one of the central principles of bioethics: respecting autonomy. This raises the question as to how community consent can be justified or even required. This paper aims to provide an answer to this question by arguing, based on the work of Taylor and Kymlicka, that community practices are important for the identity and autonomy of community members. When these practices are incompatible with a solitary focus on individual informed consent, they need to be protected by making these decision-making practices (including asking permission to community authorities) part of the consent process. Since these decision-making practices are important for the autonomy of community members, community consent with the goal of protecting these practices is not necessarily in conflict with autonomy.


Assuntos
Pesquisa Biomédica , Consentimento do Representante Legal , Humanos , Consentimento Livre e Esclarecido , Princípios Morais , Autonomia Pessoal
15.
J Am Geriatr Soc ; 69(2): 342-348, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33170957

RESUMO

BACKGROUND/OBJECTIVES: Experts have suggested that patients represented by professional guardians receive higher intensity end-of-life treatment than other patients, but there is little corresponding empirical data. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: Among veterans aged 65 and older who died from 2011 to 2013, we used Minimum Data Set assessments to identify those who were nursing home residents and had moderately severe or severe dementia. We applied methods developed in prior work to determine which of these veterans had professional guardians. Decedent veterans with professional guardians were matched to decedent veterans without guardians in a 1:4 ratio, according to age, sex, race, dementia severity, and nursing facility type (VA based vs non-VA). MEASUREMENTS: Our primary outcome was intensive care unit (ICU) admission in the last 30 days of life. Secondary outcomes included mechanical ventilation and cardiopulmonary resuscitation in the last 30 days of life, feeding tube placement in the last 90 days of life, three or more nursing home-to-hospital transfers in the last 90 days of life, and in-hospital death. RESULTS: ICU admission was more common among patients with professional guardians than matched controls (17.5% vs 13.7%), but the difference was not statistically significant (adjusted odds ratio = 1.33; 95% confidence interval = .89-1.99). There were no significant differences in receipt of any other treatment; nor was there a consistent pattern. Mechanical ventilation and cardiopulmonary resuscitation were more common among patients with professional guardians, and feeding tube placement, three or more end-of-life hospitalizations, and in-hospital death were more common among matched controls. CONCLUSION: Rates of high-intensity treatment were similar whether or not a nursing home resident with dementia was represented by a professional guardian. This is in part because high-intensity treatment occurred more frequently than expected among patients without guardians.


Assuntos
Cuidados Críticos , Demência , Tutores Legais/estatística & dados numéricos , Casas de Saúde , Assistência Terminal , Serviços de Saúde para Veteranos Militares/estatística & dados numéricos , Idoso , Cuidados Críticos/legislação & jurisprudência , Cuidados Críticos/métodos , Cuidados Críticos/estatística & dados numéricos , Demência/mortalidade , Demência/terapia , Feminino , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Masculino , Casas de Saúde/organização & administração , Casas de Saúde/estatística & dados numéricos , Transferência de Pacientes/legislação & jurisprudência , Transferência de Pacientes/estatística & dados numéricos , Estudos Retrospectivos , Índice de Gravidade de Doença , Assistência Terminal/métodos , Assistência Terminal/organização & administração , Assistência Terminal/estatística & dados numéricos , Consentimento do Representante Legal , Estados Unidos/epidemiologia
16.
Cuad Bioet ; 31(103): 309-317, 2020.
Artigo em Espanhol | MEDLINE | ID: mdl-33375798

RESUMO

Lately, number of divorces is increasing, nevertheless, a parents' divorce can become a traumatic problem for paediatric patients. Consequently, the aim of this study was to analyze the ethical conflicts that appear in the relationship between physician/parents/son/daughter, and more specifically those that a divorce generates. A descriptive study was developed through a survey composed by 39 items. Previously, an exhaustive bibliographic analysis was carried out. Our results show that only 35% of paediatricians interviewed have been educated in bioethics although this issue is important in daily practice. Other items show that 57,5% would not cancel a pharmacological treatment in order to improve quality of life. Also, they would react against a wrong parents' decision (82,5%). They give low value to the minor`s decision (6,05%), and rarely inform exclusively to adolescents (5%). In contrast, paediatricians sometimes ask to adolescents (20%) in first place and involved them to decide in 90% of cases. Besides, there are differences in the relation with fathers and mothers, 17,5% of mothers are informed exclusively, a fact that never happens with fathers. Ethics has an intrinsic value very important in daily clinical decisions in order to respect the rules and to adapt them to the situation of every paediatric patient. When an important ethical conflict become, as a divorce is, it is essential to know who must be informed and the rights everyone has to make a decision. It is complicated to the paediatricians yet to develop 41/2002 law for Patient's autonomy.


Assuntos
Divórcio/ética , Negociação , Adolescente , Fatores Etários , Bioética/educação , Criança , Custódia da Criança/ética , Direitos Civis , Tomada de Decisão Clínica , Divórcio/legislação & jurisprudência , Educação Médica , Pai , Feminino , Humanos , Consentimento Livre e Esclarecido , Masculino , Mães , Pediatras/educação , Papel do Médico , Relações Profissional-Família , Psicologia do Adolescente , Psicologia da Criança , Consentimento do Representante Legal/ética , Consentimento do Representante Legal/legislação & jurisprudência , Revelação da Verdade/ética
17.
Pediatrics ; 146(5)2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33028661

RESUMO

The current coronavirus disease 2019 (COVID-19) pandemic has triggered an intense global research effort to inform the life-saving work of frontline clinicians who need reliable information as soon as possible. Yet research done in pressured circumstances can lead to ethical dilemmas, especially for vulnerable research subjects. We present the case of a child with neurocognitive impairment who is diagnosed with COVID-19 infection after presenting with fever and a seizure. The child lives in a group home and is in the custody of the state; her parents lost parental rights many years ago. Some members of the health care team want to enroll her in a randomized clinical trial evaluating an experimental treatment of COVID-19. For minor patients to enroll in this clinical trial, the institutional review board requires assent of patients and consent of guardians. An ethics consult is called to help identify relevant concerns in enrollment. In the accompanying case discussion, we address historical perspectives on research involving people with disabilities; proper management of research participation for people with disabilities including consent by proxy, therapeutic misconception, and other threats to the ethical validity of clinical trials; and the potentially conflicting obligations of researchers and clinicians.


Assuntos
Antivirais/uso terapêutico , Betacoronavirus , Infecções por Coronavirus/tratamento farmacológico , Competência Mental , Transtornos Neurocognitivos/complicações , Pneumonia Viral/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Consentimento do Representante Legal/ética , COVID-19 , Criança , Infecções por Coronavirus/complicações , Feminino , Humanos , Pandemias , Pneumonia Viral/complicações , SARS-CoV-2
18.
Am J Public Health ; 110(12): 1786-1789, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33058705

RESUMO

Unaccompanied migrant children seeking asylum status in the United States are often forced to undergo dental radiographs, or x-rays, to verify that they are younger than 18 years.The application of third molar dental radiographs is methodologically flawed and should not be employed as a determinant of chronological age. Furthermore, the use of such tests without obtaining informed consent from either the youth or an objective advocate is unethical.Finally, the legal and health consequences of these inappropriately applied tests are severe and jeopardize the safety and security of these vulnerable minors.


Assuntos
Determinação da Idade pelos Dentes/métodos , Radiografia Dentária/ética , Refugiados , Adolescente , Criança , Humanos , Dente Serotino/diagnóstico por imagem , Radiografia Dentária/efeitos adversos , Radiografia Dentária/métodos , Consentimento do Representante Legal/ética
19.
Med Law Rev ; 28(4): 817-826, 2020 Dec 17.
Artigo em Inglês | MEDLINE | ID: mdl-33001196

RESUMO

In Re H (A Child) (Parental Responsibility: Vaccination), the Court of Appeal decided that vaccination did not represent 'grave' or 'serious' medical treatment and determined that, in the case of a child under the care of a Local Authority, court authorization for consent to and arrangement of vaccination is no longer required. This is due to the strong medical evidence in support of vaccination. Thus, with due reference to 33(3)(b) Children Act 1989 and while considering proportionality and, particularly, the proportionate response to interference with the parents' right to respect for private and family life under Article 8 of the European Convention on Human Rights, the court held that vaccination is in line with the best interests of the child. This commentary supports this judgment but identifies a slight prospective anomaly in the approach adopted to children in care and those who are not in care. The resolution of this dichotomy lies in broadening the scope of King LJ's approach in this case.


Assuntos
Relações Pais-Filho/legislação & jurisprudência , Consentimento do Representante Legal/legislação & jurisprudência , Recusa do Paciente ao Tratamento/legislação & jurisprudência , Vacinação/legislação & jurisprudência , Reino Unido
20.
Ethiop J Health Sci ; 30(3): 377-386, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32874081

RESUMO

BACKGROUND: Postmortem examination is necessary to diagnose the cause of sudden death, and family caregivers are expected to consent to this examination. This study assessed knowledge, attitude, practices and willingness of family caregivers to consent to postmortem examination of their relative if they die suddenly in a Nigerian tertiary hospital. METHODS: Descriptive cross-sectional study of family caregivers of our patients that completed an interviewer administered semistructured questionnaire assessing their knowledge, attitude, practices and willingness to consent to postmortem examination of their relative if they die suddenly. Data were analyzed using descriptive and inferential statistics. RESULTS: A total of 224 caregivers were interviewed. The mean age (SD) was 34.95 (11.74), ranging 22-75 years. They were parents (32.6%), siblings (37.9%), spouses (11.2%) and other relatives (18.3%). Only 17% had adequate knowledge, 44.6% positive attitude and 11.2% good practices to postmortem examination of sudden death. The majority (75.9%) would consent to postmortem examination of their relatives if they die suddenly. Sociodemographic variables associated with willingness to consent to postmortem examination after relative's sudden death include being male (AOR 3.61; 95%CI 3.09-8.92; p=0.001), having tertiary education (AOR 4.83; 95%CI 1.01-8.29; p=0.034), Christianity (AOR 2.59; 95%CI 1.25-5.35; p=0.010) and skilled worker (AOR 1.43; 95%CI 1.33-3.80; p=0.020). CONCLUSION: Some family caregivers would not consent to postmortem examination of their relatives when they die suddenly. Sensitization programs targeting family caregivers are necessary to increase knowledge and enhance prevention of sudden death as well as improve willingness to consent to postmortem examination when their relatives die suddenly.


Assuntos
Autopsia , Morte Súbita , Família/psicologia , Consentimento Livre e Esclarecido/psicologia , Consentimento do Representante Legal , Adulto , Idoso , Estudos Transversais , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Nigéria , Inquéritos e Questionários , Centros de Atenção Terciária , Adulto Jovem
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