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1.
Niger J Clin Pract ; 23(6): 754-758, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32525107

RESUMO

Background: To evaluate the extent of recall of consent information by daycare prostate biopsy patients in our low-literacy setting. And to evaluate the role of a 3rd party check on patient's recall of consent information. Subjects and Methods: As part of our standard of care, a formal informed consent session for day care prostate biopsy takes place 3 days prior to the procedure. For this study, before leaving the outpatient clinic the same day, the patient acknowledged before a third-party that his concerns were or were not satisfactorily addressed. The extent of recall of consent information was assessed on the morning of the procedure using a researcher-administered questionnaire. Consecutive patients participated in this cross-sectional study for day care prostate biopsy at a tertiary hospital in southeast Nigeria from February to November 2015 after obtaining due consent. Results: The recall of the risks associated with the planned procedure was poorer than the recall of the nature of the disease condition or the nature of the planned procedure. However, it was observed that aggregate recall was significantly poorer among patients who negatively attested to a satisfying consent session (OR 0.125; P < 0.0005). Conclusion: The use of a third-party in determining patient satisfaction after a consent session may be a better indicator of patient comprehension and subsequent recall of consent information, especially in low-literacy settings. Using a third-party, in this manner, may assist in checking paternalism inherent in the patient-doctor relationship.


Assuntos
Compreensão , Hospital Dia/estatística & dados numéricos , Consentimento Livre e Esclarecido , Rememoração Mental , Satisfação do Paciente , Próstata/patologia , Idoso , Idoso de 80 Anos ou mais , Biópsia , Estudos Transversais , Feminino , Pesquisas sobre Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Nigéria , Relações Médico-Paciente , Consentimento do Representante Legal
3.
Am J Bioeth ; 20(2): 44-48, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31990251

RESUMO

Incapacitated adult patients are commonly divided into two groups for purposes of decision making; those with a surrogate and those without. Respectively, these groups are often referred to as represented and unrepresented, and the relative ethics of decision making between them raises two particular issues. The first issue involves the differential application of the best interests standard between groups. Second is the prevailing notion that representedness and unrepresentedness are categorical phenomena, though it is more aptly understood as a multidimensional and continuous variable based on relational moral authority. This paper examines the nature of representedness as it relates to ethical norms of surrogate decision making.


Assuntos
Tomada de Decisões/ética , Defesa do Paciente/classificação , Defesa do Paciente/normas , Procurador , Consentimento do Representante Legal/ética , Adulto , Idoso , Humanos , Princípios Morais , Normas Sociais
5.
Narrat Inq Bioeth ; 9(2): 173-177, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31447455

RESUMO

A living will is a document in which an individual can communicate his or her health care choices to loved ones in the event that he or she is unable to do so directly. Many surrogate decision-makers use living wills as guides; however, the existence of such documents does not entirely relieve them of their burden. Surrogate decision-makers often need to consider the impact of the personal and family burdens entailed by their decisions, and the stress accompanying these burdens regularly creates high levels of anxiety and depression. This stress can be exacerbated when two surrogate decision-makers are at loggerheads as to the best way forward. This case study illustrates the effects of stress accompanying disagreement among surrogate decision-makers-here, the patient's adult sons-and demonstrates that a process of listening can help the bioethicist identify the values that are important to the patient and, consequently, to the surrogate as well, and use these values to help address the issue.


Assuntos
Diretivas Antecipadas/ética , Cuidados Críticos/ética , Pai , Consentimento do Representante Legal/ética , Idoso , Dissidências e Disputas , Neoplasias de Cabeça e Pescoço/terapia , Humanos , Testamentos Quanto à Vida/ética , Masculino , Carcinoma de Células Escamosas de Cabeça e Pescoço/terapia
6.
Trials ; 20(1): 408, 2019 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-31288829

RESUMO

BACKGROUND: Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience additional distress. EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients' quality of life and death and dying as well as surrogates' mental health. METHODS: Clinician stakeholder and surrogate participant feedback (n = 15), as well as results from an open trial (n = 10), will be used to refine the intervention, which will then be evaluated through a multisite randomized controlled trial (RCT) (n = 60) to examine clinical superiority to usual care. Feasibility, tolerability, and acceptability of the intervention will be evaluated through self-report assessments. Hierarchical linear modeling will be used to adjust for clustering within interventionists to determine the effect of EMPOWER on surrogate differences in the primary outcome, peritraumatic stress. Secondary outcomes will include symptoms of post-traumatic stress disorder, prolonged grief disorder, and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at 1 and 3 months from post-intervention assessment. Linear regression models will examine the effects of assignment to EMPOWER versus the enhanced usual care group on patient quality of life or quality of death and intensity of care the patient received during the indexed ICU stay assessed at the time of the post-intervention assessment. Participant exit interviews will be conducted at the 3-month assessment time point and will be analyzed using qualitative thematic data analysis methods. DISCUSSION: The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver outcomes in the setting of critical illness. The experimental intervention will be strengthened through the input of a variety of ICU stakeholders, including behavioral health clinicians, physicians, bereaved informal caregivers, and open trial participants. Results of the RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03276559 . Retrospectively registered on 8 September 2017.


Assuntos
Cuidadores/psicologia , Comportamento de Escolha , Terapia Cognitivo-Comportamental , Cuidados Críticos , Emoções , Saúde Mental , Procurador/psicologia , Resiliência Psicológica , Estresse Psicológico/terapia , Consentimento do Representante Legal , Estudos de Equivalência como Asunto , Humanos , Unidades de Terapia Intensiva , Estudos Multicêntricos como Assunto , Cidade de Nova Iorque , Qualidade de Vida , Estresse Psicológico/etiologia , Estresse Psicológico/psicologia , Fatores de Tempo , Resultado do Tratamento
7.
Acad Emerg Med ; 26(10): 1158-1168, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31271691

RESUMO

OBJECTIVES: Community consultation is required for clinical trials considering federal exception from informed consent (EFIC) procedures. Questions remain about the value of the community consult process and whether it adds intended protections to study subjects. Public deliberation methods that provide baseline participant education and elicit values and opinions about consent options is a novel approach for community consultation. This study evaluated the use of structured public deliberation methods to assess a community's values and opinions about informed consent procedures for a pediatric trauma trial. METHODS: This was a mixed-methods descriptive study of public deliberation sessions assessing participants' opinions about informed consent procedures for a pediatric trauma randomized controlled trial (RCT). Participants from communities with high rates of pediatric trauma were recruited via community-based organizations and social media. Deliberation focused on three consent options for a proposed RCT: 1) enrollment using EFIC procedures with no attempt to obtain informed consent, 2) enrollment using EFIC procedures after attempting to reach a parent, or 3) enrollment only with informed consent. Participant demographic data and their opinions about the proposed study and deliberative session were also collected. RESULTS: There were 102 participants across eight sessions (range of nine to 15/session, mean of 13). Most participants were female (n = 78, 76%) and a plurality were black (n = 48, 47%). The majority of participants preferred enrollment using EFIC procedures only after an attempt was made to reach a parent and informed consent was not possible (n = 56, 55%), followed by enrollment using EFIC procedures with no attempt to obtain informed consent (n = 32, 32%), and enrollment only with written informed consent (n = 13, 13%). One participant declined all options. Eighty-four participants (82%) agreed or strongly agreed that the RCT was important to do, and 79 participants (77%) said that the sessions provided enough information to make an informed decision about the proposed RCT. CONCLUSIONS: Structured public deliberation is an effective approach when consulting communities for trials considering EFIC procedures. Future studies are needed to evaluate whether public deliberation methods provide participants with enhanced understanding of clinical trials compared to other community consultation methods.


Assuntos
Consentimento Livre e Esclarecido , Consentimento do Representante Legal , Feminino , Humanos , Masculino , Seleção de Pacientes/ética , Pesquisa Qualitativa , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
9.
Trials ; 20(1): 233, 2019 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-31023383

RESUMO

BACKGROUND: Research involving adults who lack the capacity to provide informed consent can be challenging. In England and Wales there are legal provisions for consulting with others who know the person with impaired capacity. The role of the 'proxy' (or 'surrogate') is to advise researchers about the person's wishes and feelings or to provide consent on the person's behalf for a clinical trial of a medicine. Information about the study is usually provided to the proxy; however, little information is available to proxies about their role, or the appropriate legal and ethical basis for their decision, to help inform their decision-making. The aim of this study was to analyse the written information that is provided to consultees and legal representatives. METHODS: Studies including adults lacking capacity to consent which utilised consultees or legal representatives were identified using the UK Clinical Trials Gateway database. A representative sample (n = 30) were randomly selected. Information sheets and other study documents provided to proxies were obtained, and relevant content was extracted. Content analysis was conducted through four stages: decontextualisation of the unit of analysis, recontextualisation, categorisation, and compilation. The data were summarised narratively according to each theme and category. RESULTS: Considerable variation was found in the written information sheets provided to proxies. Most directed proxies to consider the wishes and feelings of the person who lacked capacity and to consult with others during the decision-making process. However, a small number of studies extended the scope of the proxy's role to consider the person's suitability or eligibility for the study. Particular discrepancies were found in information provided to those acting as consultees or legal representatives in a professional, as opposed to a personal, capacity. Incorrect uses of terminology were frequently found, and a small number of studies inaccurately interpreted the law. CONCLUSIONS: Despite undergoing ethical review, study documents lacked essential information, incorrectly used terminology, and conflated professionals' clinical and representation roles. Future recommendations include ensuring proxies are provided with adequate and accurate information which complies with the legal frameworks. Further research is needed to explore the information and decision-making needs of those acting as consultees and legal representatives.


Assuntos
Termos de Consentimento/legislação & jurisprudência , Disseminação de Informação/legislação & jurisprudência , Competência Mental/legislação & jurisprudência , Procurador/legislação & jurisprudência , Ensaios Clínicos Controlados Aleatórios como Assunto/legislação & jurisprudência , Projetos de Pesquisa/legislação & jurisprudência , Consentimento do Representante Legal/legislação & jurisprudência , Comportamento de Escolha , Definição da Elegibilidade/legislação & jurisprudência , Humanos , Reino Unido
11.
Transplant Proc ; 51(3): 619-624, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30979443

RESUMO

BACKGROUND: In 2010, the Chinese government started a pilot project of donation after Chinese citizens' death. Seeking the consent of the families of potential donors is an important task in the organ donation process. OBJECTIVE: We aimed to explore the factors that influence the families' decision-making for organ donation. METHODS: We performed a content analysis of 30 semistructured in-depth interviews with immediate family members who made the decision for an organ donation. The interviewees were asked questions such as how the decision to donate was made, what factors influenced the decision, and whether the decision was rejected by relatives and friends. RESULTS: The interviewees were the donors' parent (15; 50%), spouse (9; 30%), brother (3; 10%) or son (3; 10%), including 18 men and 12 women, with a mean age of 41.6 (standard deviation, 10.7) years; rural households accounted for 83.3%. Through analyzing the interview notes, 17 factors ware mentioned by interviewees, and 3 types of decision-making in organ donors' families were obtained. Then, the factors affecting the decisions of the donor families were classified into 3 categories and 11 subcategories. CONCLUSIONS: Factors influencing the families' decision-making for organ donation were analyzed preliminarily in this study.


Assuntos
Tomada de Decisões , Consentimento do Representante Legal , Doadores de Tecidos/psicologia , Doadores de Tecidos/provisão & distribução , Obtenção de Tecidos e Órgãos , Adulto , Criança , China , Família/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transplante de Órgãos/psicologia , Projetos Piloto
12.
Exp Clin Transplant ; 17(Suppl 1): 110-112, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30777533

RESUMO

OBJECTIVES: The method of obtaining family consent for organ donation after occurrence of brain death in Iran is an opt-in process. Because of complicated cultural, legal, religious, and familial structures in Iran, it is not simple to take consent for organ donation in brain death situations. The process needs the professional staff to be experienced and have an appropriate personality to obtain consent. MATERIALS AND METHODS: We previous used a limited number of experienced coordinators to take consent. We revised our decision 2 years ago because of lack of trained personnel. From the beginning of 2017, we have started training courses regarding approaching families for donations for all interested coordinators. After participants finished the theoretical and practical training, we allowed them to interview themselves to practice a first evaluation for a suitable potential donor. We have continued this strategy and have gathered feedback from participating coordinators. RESULTS: At the beginning of 2017, 9 coordinators who were previously qualified for handling other steps of organ donation were put into a compact training program to train for family interviews. In 2016, the experienced interviewers had a 88% success rate compared with a success rate of 83% in 2017 for inexperienced interviewers (P = .1). No significant differences were shown. Despite younger ages of donors obtained in 2017, median donated organs per donor decreased from 2.81 to 2.66. The average time interval between first contact with families and establishment of family consent was not significantly different between experienced and inexperienced coordinators (9.2 vs 8.7 h). CONCLUSIONS: Although with the new strategy we experiensed a decrease in the consent rate, we believe this strategy will have long-term beneficial effects for our organization and the decreased rate will be a temporary decline. Interviews showed that this strategy made our coordinators more motivated and responsible for their job. As a result, both volume and quality of organ procurement activities will be increased.


Assuntos
Morte Encefálica , Comunicação , Família/psicologia , Pessoal de Saúde/educação , Capacitação em Serviço/métodos , Consentimento do Representante Legal , Doadores de Tecidos/provisão & distribução , Obtenção de Tecidos e Órgãos , Conhecimentos, Atitudes e Prática em Saúde , Pessoal de Saúde/organização & administração , Humanos , Irã (Geográfico) , Relações Profissional-Família , Obtenção de Tecidos e Órgãos/organização & administração
13.
Clin Transplant ; 33(3): e13488, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30689228

RESUMO

The current study evaluates the Positive Deviance Donation Collaborative, a communication training program designed to identify and disseminate behaviors of requesters with above-average rates of familial authorization to organ donation. The program initiated with a cohort of 99 requesters from 11 OPOs. Requesters' quarterly authorization rates were monitored for 33 months, and their pre-/post-intervention skills in active-empathic listening and self-efficacy to request donation were assessed. Overall, requesters' mean quarterly authorization rate was 53.69% (SD = 4.54). Multilevel models were used to examine change in authorization rates and communication skills, as well as associations between skills and authorization. Low intraclass correlation coefficients for authorization rates established that most variance was due to within-requester variation, rather than OPOs (ρ = 0.0129) or requesters within OPOs (ρ = 0.0221). Models indicated that authorization rates and communication skills failed to improve following intervention and did not identify an association between post-intervention communication skills and authorization. Results provide a framework to discuss programmatic challenges including extensive requester turnover (ie, ~60%), management of data collection across multi-site interventions, and program content.


Assuntos
Comunicação , Tomada de Decisões , Família/psicologia , Transplante de Órgãos , Consentimento do Representante Legal/estatística & dados numéricos , Doadores de Tecidos/psicologia , Obtenção de Tecidos e Órgãos/estatística & dados numéricos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
14.
J Crit Care ; 49: 155-157, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30439630

RESUMO

Critical care physicians may hear a surrogate decision-maker ask, "What would you do if she was your mother?" or "What if your father was this sick?" These kinds of questions ask more of the critical care physician than the surrogate might realize. There are deep-seated ethical, professional, and personal complexities that can challenge critical care physicians to answer these questions with honesty. This essay offers practical guidance for critical care physicians who aim to respond to such queries with honesty and beneficence. We discuss a variety of motivations that can accompany this unique kind of question from a surrogate. The surrogate may be seeking moral guidance-the true question being, "What should I do?" We offer a number of questions that the critical care physician might ask of the surrogate in order to attend to both the surrogate's moral dilemma and the patient's values and preferences for medical interventions. We also offer a number of questions to promote contemplation of these issues by the critical care physician herself. We argue that until the critical care physician: discovers the surrogate's motivation, connects this motivation to patient preferences, and asks herself important questions regarding death and dying, the physician's responses will not adequately attend to the issues prompted by such questions.


Assuntos
Relações Profissional-Família , Assistência Terminal/ética , Tomada de Decisão Clínica/ética , Cuidados Críticos/ética , Dissidências e Disputas , Humanos , Princípios Morais , Médicos , Consentimento do Representante Legal
15.
Med Klin Intensivmed Notfmed ; 114(2): 122-127, 2019 03.
Artigo em Alemão | MEDLINE | ID: mdl-30465267

RESUMO

BACKGROUND: Communication with relatives is a central part of the decision-making process. In the absence of the patient's direct consent to a potential organ donation, the next of kin must provide information about a potential wish to donate and give permission in the context of an extended consent solution. At the same time, family members must also cope with the death of a loved one. OBJECTIVE: To determine how relatives can be optimally supported during the decision-making process. MATERIALS AND METHODS: Narrative review. RESULTS: In the context of potential or confirmed irreversible brain death, communication with family members or legal representatives serves to deliver bad news as well as to determine whether the patient had a wish to donate his/her organs and to clarify the resultant steps. Communication strategies such as the SPIKES or VALUE models provide emotional and cognitive support for relatives and strengthen clinicians' communication skills. Clinicians' behavior towards patients, deceased, and next of kin may influence relatives' decision-making; respectful and competent behavior seems to contribute towards relatives granting permission for organ donation. CONCLUSION: Clinicians must be trained and skilled in communication strategies which are used in critical situations to provide emotional support to relatives during the organ donation decision-making process. Relatives are more likely to achieve a satisfying and sustainable decision if a strong relationship exists between clinicians and relatives based on information giving, openness, trust, and empathy.


Assuntos
Comunicação , Família/psicologia , Doadores de Tecidos , Obtenção de Tecidos e Órgãos , Morte Encefálica , Morte , Tomada de Decisões , Feminino , Humanos , Masculino , Consentimento do Representante Legal
16.
J Med Ethics ; 45(1): 18-21, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30219797

RESUMO

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.


Assuntos
Ensaios Clínicos como Assunto/ética , Serviços Médicos de Emergência , Consentimento Livre e Esclarecido/ética , Lesões Encefálicas/terapia , Ensaios Clínicos como Assunto/legislação & jurisprudência , Serviços Médicos de Emergência/ética , Serviços Médicos de Emergência/legislação & jurisprudência , Regulamentação Governamental , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Infarto do Miocárdio/terapia , Seleção de Pacientes/ética , Choque Hemorrágico/terapia , Consentimento do Representante Legal/ética , Consentimento do Representante Legal/legislação & jurisprudência , Estados Unidos , Ferimentos e Lesões/terapia
19.
Narrat Inq Bioeth ; 9(3): 247-257, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31956129

RESUMO

This case study concerns the predicaments faced by two women who each had been advised by her physicians to have a gangrenous foot amputated to prevent the potentially fatal spread of infection. In both cases, the determination of the patients' decisional capacity was a critical component in judging whether or not to honor their medical treatment decisions. The communicative complexity of navigating a double bind, a situation in which a person confronts a choice between two undesirable courses of action, is also discussed. The patients in these cases had no medically appropriate choice that also respected other valued outcomes, such as independence, a sense of dignity, or control over one's destiny. Taken together, these cases raise issues about the context-specific meaning of decisional capacity and its role in informed consent.


Assuntos
Amputação , Tomada de Decisões/ética , Consentimento Livre e Esclarecido/psicologia , Consentimento do Representante Legal/ética , Recusa do Paciente ao Tratamento/psicologia , Idoso , Análise Ética , Feminino , Humanos , Pessoa de Meia-Idade
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