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3.
J Visc Surg ; 157(4): 317-327, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32600823

RESUMO

Bariatric/metabolic surgery was paused during the Covid-19 pandemic. The impact of social confinement and the interruption of this surgery on the population with obesity has been underestimated, with weight gain and worsened comorbidities. Some candidates for this surgery are exposed to a high risk of mortality linked to the pandemic. Obesity and diabetes are two major risk factors for severe forms of Covid-19. The only currently effective treatment for obesity is metabolic surgery, which confers prompt, lasting benefits. It is thus necessary to resume such surgery. To ensure that this resumption is both gradual and well-founded, we have devised a priority ranking plan. The flow charts we propose will help centres to identify priority patients according to a benefit/risk assessment. Diabetes holds a central place in the decision tree. Resumption patterns will vary from one centre to another according to human, physical and medical resources, and will need adjustment as the epidemic unfolds. Specific informed consent will be required. Screening of patients with obesity should be considered, based on available knowledge. If Covid-19 is suspected, surgery must be postponed. Emphasis must be placed on infection control measures to protect patients and healthcare professionals. Confinement is strongly advocated for patients for the first month post-operatively. Patient follow-up should preferably be by teleconsultation.


Assuntos
Cirurgia Bariátrica/normas , Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Controle de Infecções/normas , Obesidade/cirurgia , Pandemias/prevenção & controle , Assistência Perioperatória/normas , Pneumonia Viral/prevenção & controle , Cirurgia Bariátrica/métodos , Infecções por Coronavirus/complicações , Infecções por Coronavirus/diagnóstico , Procedimentos Clínicos/normas , Humanos , Controle de Infecções/métodos , Consentimento Livre e Esclarecido/normas , Obesidade/complicações , Seleção de Pacientes , Assistência Perioperatória/métodos , Pneumonia Viral/complicações , Pneumonia Viral/diagnóstico
4.
Eur Heart J ; 41(22): 2109-2117, 2020 06 07.
Artigo em Inglês | MEDLINE | ID: covidwho-526858

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus , Insuficiência Cardíaca , Pandemias , Pneumonia Viral , Projetos de Pesquisa/normas , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Europa (Continente) , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/terapia , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Segurança do Paciente , Seleção de Pacientes/ética
5.
Medicine (Baltimore) ; 99(21): e20225, 2020 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-32481294

RESUMO

We examined the process of obtaining informed consent (IC) for clinical research purposes in long-term care facilities (LTCFs) in Rhode Island (RI), USA. We assessed factors that were associated with resident ability to consent, such as Brief Interview for Mental Status scores. We used a self-administered questionnaire to further understand the effect of LTCF staff evaluation of ability to consent on residents' autonomy and control over their medical decision making.Observational clinical studyLong-term care setting.LTCF personnel provided us with residents' names, as well as their professional assessment of resident ability to consent. We used Brief Interview for Mental Status (BIMS) scores to assess the cognitive capacity of all residents to assess, and compare it to the assessment provided by LTCF personnel. A logistic regression analysis was performed to determine the relationship between LTCF assessment of resident ability to consent and BIMS score or confirmed diagnosis of dementia as seen from residents' medical charts. A self-administered questionnaire was filled out by the personnel of 10 LTCFs across RI, USA.LTCF personnel in 9 out of 10 recruited facilities reported that their assessment of resident ability to consent was based on subjective assessment of the resident as alert and oriented. There was a statistically significant relationship between the LTCF assessment of resident ability to consent and previously diagnosed dementia (OR: 0.211, 95% CI 0.107-0.415). Therefore, as BIMS scores increased, the likelihood that the resident would be deemed able to consent by LTCF personnel also increased. Furthermore, there was a statistically significant relationship between LTCF assessment of resident ability to consent and BIMS scores (OR: 1.430, 95% CI 1.274-1.605).There is no standard on obtaining IC for research studies conducted in LTCFs. We recommend that standardizing the process of obtaining IC in LTCFs can enhance the ability to perform research with LTCF residents.


Assuntos
Protocolos Clínicos/normas , Demência/diagnóstico , Consentimento Livre e Esclarecido/normas , Assistência de Longa Duração/ética , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisão Clínica/métodos , Demência/psicologia , Feminino , Humanos , Assistência de Longa Duração/psicologia , Assistência de Longa Duração/estatística & dados numéricos , Masculino , Testes de Estado Mental e Demência/normas , Pessoa de Meia-Idade , Rhode Island/epidemiologia , Inquéritos e Questionários
6.
Eur Heart J ; 41(22): 2109-2117, 2020 06 07.
Artigo em Inglês | MEDLINE | ID: mdl-32498081

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus , Insuficiência Cardíaca , Pandemias , Pneumonia Viral , Projetos de Pesquisa/normas , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Europa (Continente) , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/terapia , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Segurança do Paciente , Seleção de Pacientes/ética
8.
J Med Internet Res ; 22(5): e16879, 2020 05 28.
Artigo em Inglês | MEDLINE | ID: mdl-32463372

RESUMO

Tremendous growth in the types of data that are collected and their interlinkage are enabling more predictions of individuals' behavior, health status, and diseases. Legislation in many countries treats health-related data as a special sensitive kind of data. Today's massive linkage of data, however, could transform "nonhealth" data into sensitive health data. In this paper, we argue that the notion of health data should be broadened and should also take into account past and future health data and indirect, inferred, and invisible health data. We also lay out the ethical and legal implications of our model.


Assuntos
Segurança Computacional/normas , Consentimento Livre e Esclarecido/normas , Humanos
11.
Rev Esp Salud Publica ; 942020 May 05.
Artigo em Espanhol | MEDLINE | ID: mdl-32382000

RESUMO

OBJECTIVE: Terminal patients and their relatives must know their real situation, and be treated according to the principle of autonomy, to establish therapeutic objectives adapted each one, according to their needs and decisions. The objective of this study is to identify the sufficient existence of records in the Medical Histories of terminal patients, which indicate their situation, such as the information given to the patients, or the LET, No-RCP or Z.51.5 codes, and the statistical relation they have with the sociodemographic and clinical variables. METHODS: Cross-sectional study in a third-level hospital, with patients admitted between January and December 2017, who died with terminal illness criteria. Data were collected from the medical records, and, fundamentally, from the nursing clinical notes. The statistical analysis was performed with the SPSS program, version 22. RESULTS: Participants were 140 people, 54.3% men, of 78.51 (SD=13.5) of middle age. People up to 70 years of age received less information (Odds ratio (OR): 0.077, 95% Confidence interval (CI): 0.015-0.390) and lower sedation (OR: 0.366, 95% CI: 0.149-0.899). Proceeding from city reduced the probability of receiving information (OR: 0.202; IC95%: 0.058-0.705). Presenting dyspnea reduced LTE (OR: 0.44, 95% CI: 0.20-093), No CPR (0.29, 95% CI: 0.12-0.68) and sedation (OR: 0.27; 95% CI: 0.12-060). Fatigue increased the probability of being Non-CPR (OR: 2.77, 95% CI: 1.166-6.627) and of receiving sedation (OR: 2.6, 95% CI: 1.065-6.331). CONCLUSIONS: Efforts to empower the patient in the decision of their process and the management of the information of their diagnosis and prognosis are still lacking. A greater and better clinical records facilitates knowing how actions are developed, allowing to identify and implement ethical and responsible interventions.


Assuntos
Diretivas Antecipadas/ética , Registros Médicos , Participação do Paciente , Autonomia Pessoal , Melhoria de Qualidade/ética , Assistência Terminal/ética , Centros de Atenção Terciária/ética , Adulto , Diretivas Antecipadas/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Tomada de Decisões/ética , Feminino , Hospitalização , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Consentimento Livre e Esclarecido/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Participação do Paciente/métodos , Participação do Paciente/estatística & dados numéricos , Melhoria de Qualidade/estatística & dados numéricos , Estudos Retrospectivos , Espanha , Assistência Terminal/normas , Assistência Terminal/estatística & dados numéricos , Centros de Atenção Terciária/normas , Centros de Atenção Terciária/estatística & dados numéricos
12.
JAMA Netw Open ; 3(5): e205435, 2020 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-32442291

RESUMO

Importance: Information to be included in advance informed consent forms for health care-associated pneumonia treatment trials remains to be determined. Objective: To identify and determine how to describe information to be included in an advance informed consent form for an early-enrollment noninferiority hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) clinical trial. Design, Setting, and Participants: A Delphi consensus process with stakeholders in HABP/VABP clinical trials was conducted using qualitative semistructured telephone interviews from June to August 2016, followed by 2 online surveys, the first from April to May 2017, and the second from September to October 2017. All stakeholders who participated in the interview were invited to participate in the first survey. Stakeholders who participated in the first survey were invited to participate in the second survey. Stakeholders were patients at risk of pneumonia, caregivers, representatives of institutional review boards, investigators, and study coordinators. Main Outcomes and Measures: Description and consensus of information to be included in advance informed consent forms for early enrollment in noninferiority HABP/VABP clinical trials. Results: Suggestions from 52 stakeholders about what key informed consent concepts to include and how to explain them were used to create 3 categories to be included in an advance consent form: (1) reassurances on patient health and treatment, (2) rationale for advance consent and early enrollment, and (3) an explanation of noninferiority. At the end of the Delphi process, at least 80% consensus was reached among the 40 stakeholders who participated in the second online survey on each of the statements to include in the proposed consent text. Throughout the process, however, describing and reaching consensus on statements about noninferiority was more problematic than the other categories. Conclusions and Relevance: The stakeholders endorsed consent language to be used in combination with a strategy for enrolling patients at highest risk for pneumonia before infection onset. Data-driven consent language may help potential participants make informed decisions about their involvement in clinical research and improve enrollment rates, which are necessary to evaluate new treatments and improve patient care. The proposed consent language may be adapted for other trials using an early enrollment strategy and for noninferiority trials.


Assuntos
Ensaios Clínicos como Assunto/ética , Pneumonia Associada a Assistência à Saúde/terapia , Consentimento Livre e Esclarecido/normas , Adulto , Idoso , Ensaios Clínicos como Assunto/métodos , Termos de Consentimento/normas , Técnica Delfos , Feminino , Humanos , Idioma , Masculino , Pessoa de Meia-Idade , Pneumonia Associada à Ventilação Mecânica/terapia , Participação dos Interessados
14.
Plast Reconstr Surg ; 145(5): 1323-1330, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32332559

RESUMO

Clinical research remains at the forefront of academic practice and evidence-based medicine. Unfortunately, history has shown that human subjects are vulnerable to experimentation without regard for their own dignity and informed decision-making. Subsequently, it is vital for research institutes to uphold safeguards and ethical conscientiousness toward human subjects. The establishment of federal regulations and the development of institutional review boards have set guidance on these processes. On January 21, 2019, final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") went into effect. The purpose of this article is to review changes to the Common Rule and discuss their impact on plastic surgery research.


Assuntos
Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa/normas , Experimentação Humana/ética , Projetos de Pesquisa/normas , Cirurgia Plástica/ética , Academias e Institutos/ética , Academias e Institutos/normas , Pesquisa Biomédica/normas , Medicina Baseada em Evidências/ética , Medicina Baseada em Evidências/normas , Experimentação Humana/normas , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Cirurgia Plástica/normas , Estados Unidos
16.
Educ. med. (Ed. impr.) ; 21(2): 106-111, mar.-abr. 2020. graf, tab
Artigo em Inglês | IBECS | ID: ibc-194477

RESUMO

INTRODUCTION: Training through medical simulation allows for continuous learning under controlled conditions. Simulation-based training activities can be used simultaneously with other educational strategies to strengthen the attitudinal skills needed to develop an informed consent process in the context of health research. OBJECTIVE: To facilitate learning in undergraduate medicine students, and to evaluate their competences to carry out an informed consent process in a scenario that resembles reality. MATERIALS AND METHODS: In this semi-longitudinal study, a simulation-based activity was conducted with 136 medical students of the fourth (Group A) and fifth year (Group B) of the Marist University of Mérida, in southern Mexico. RESULTS: The mean score for both groups was 72.48 ± 1.05 (95% CI = 70.4-74.5); 86.2 ± 0.96 (95% CI = 84.2-88.0); and 77.7 ± 0.72 (95% CI = 76.3-79.1), in the pre-test, the simulation and the post-test, respectively. The students of group A self-evaluated their performance with 3.93/5.00, and those of Group B, 4.04/5.00. DISCUSSION: This study showed that Group A students did not score lower on simulation-based activity when compared to students in Group B, suggesting that before the fifth year of undergraduate medical education, students could properly develop an informed consent-process for health research if they receive early education about medical ethics and research bioethics. Issues related to bioethics in human health research can be included as soon as medical students initiate research methodology courses


INTRODUCCIÓN: La capacitación mediante la simulación médica permite un aprendizaje continuo bajo condiciones controladas. Las actividades de capacitación basadas en simulación se pueden utilizar simultáneamente con otras estrategias educativas para fortalecer las habilidades actitudinales que se necesitan para desarrollar un proceso de consentimiento informado en el contexto de la investigación en salud. OBJETIVO: Facilitar un aprendizaje en estudiantes de medicina de pregrado y evaluar sus competencias para llevar a cabo un proceso de consentimiento informado en un escenario que semeje la realidad. MATERIALES Y MÉTODOS: En este estudio semilongitudinal desarrollamos una actividad basada en simulación con 136 estudiantes de medicina de cuarto (grupo A) y quinto año (grupo B) de la Universidad Marista de Mérida, al sur de México. RESULTADOS: El puntaje promedio para ambos grupos fue 72,48 ± 1,05 (IC 95% = 70,4-74,5); 86,2 ± 0,96 (IC 95% = 84,2-88,0), y 77,7 ± 0 72 (IC 95% = 76,3-79,1) en el pre-test, la simulación y el pos-test, respectivamente. Los estudiantes del grupo A se autoevaluaron con 3,93/5,00 y los del grupo B, 4,04/5,00. DISCUSIÓN: Nuestro estudio mostró que los estudiantes del grupo A no tenían puntajes más bajos en la actividad basada en simulación al compararlos con los estudiantes en el grupo B, sugiriendo que antes del quinto año de educación médica de pregrado los estudiantes podrían desarrollar adecuadamente un proceso de consentimiento siempre que reciban educación temprana sobre ética médica y bioética de investigación. Los temas relacionados con la bioética en la investigación en salud humana pueden incluirse tan pronto como los estudiantes de medicina inician los cursos de metodología de la investigación


Assuntos
Humanos , Masculino , Adulto Jovem , Adulto , Treinamento por Simulação/métodos , Educação de Graduação em Medicina/métodos , Consentimento Livre e Esclarecido/normas , Pesquisa Biomédica/normas , Estudos Longitudinais
17.
J Med Internet Res ; 22(3): e17612, 2020 03 30.
Artigo em Inglês | MEDLINE | ID: mdl-32224492

RESUMO

BACKGROUND: Connected medical technology is increasingly prevalent and offers both a host of new therapeutic potentials and cybersecurity-related considerations. Current practice largely does not include discussions of cybersecurity issues when clinicians obtain informed consent. OBJECTIVE: This paper aims to raise awareness about cybersecurity considerations for connected medical technology as they relate to informed consent discussions between patients and clinicians. METHODS: Clinicians, health care cybersecurity researchers, and informed consent experts propose the concept of a cybersecurity informed consent for connected medical technology. RESULTS: This viewpoint discusses concepts designed to facilitate further discussion on the need, development, and execution of cybersecurity informed consent. CONCLUSIONS: Cybersecurity informed consent may be a necessary component of informed consent practices, as connected medical technology proliferates in the health care environment.


Assuntos
Segurança Computacional/normas , Consentimento Livre e Esclarecido/normas , Humanos
18.
NeuroRehabilitation ; 46(2): 255-257, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32145004

RESUMO

BACKGROUND: Multiple sclerosis (MS) is one of the major causes of chronic neurologic disability in young adults. OBJECTIVE: To evaluate the effectiveness of information provision interventions for people with MS that aim to promote informed choice and improve patient-relevant outcomes. METHODS: To summarize and to discuss the rehabilitation perspective on the published Cochrane Review "Information provision for people with multiple sclerosis" by Köpke S et al. RESULTS: 11 studies (with 1387 participants) with important clinical heterogeneity on the definitions of interventions and outcomes assessed were included, showing that information provision interventions vs optimized standard care probably slightly increase patients' knowledge and may make little or no difference to decision making and quality of life. CONCLUSIONS: It is very important to provide information to patients for informed consent and to increase their knowledge and decision-making capacity.


Assuntos
Tomada de Decisões , Consentimento Livre e Esclarecido/psicologia , Esclerose Múltipla/psicologia , Esclerose Múltipla/terapia , Qualidade de Vida/psicologia , Tomada de Decisões/fisiologia , Humanos , Consentimento Livre e Esclarecido/normas , Educação de Pacientes como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Resultado do Tratamento
20.
New Bioeth ; 26(1): 3-16, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32072871

RESUMO

Experimental therapies with embryonic stem cells (hESCs) and, more recently, human induced pluripotent stem cells (hiPSCs) are steadily gaining ground in clinical practice. The implementation of such novel high-risk/high-potential treatments calls for proper safeguards for the interests of the public and, most importantly, of research participants directly affected by the design and outcomes of trials. We argue that the active involvement of stakeholders in decision-making is ethically required. Public and patient involvement is a necessary prerequisite for dealing responsibly with high-risk/high-potential clinical research such as stem-cell research. Moreover, there is an urgent need for public debate, regionally and globally, about the present and future value of such types of research. A stakeholder approach that pays attention to all of the people and institutions involved, including patients and their organizations, will guide the translational process and maintain the public's trust in such a rapidly evolving scientific field.


Assuntos
Ensaios Clínicos como Assunto/ética , Células-Tronco Embrionárias , Células-Tronco Pluripotentes Induzidas , Participação dos Interessados , Pesquisa com Células-Tronco/ética , Pesquisa Médica Translacional/ética , Tomada de Decisões , Humanos , Consentimento Livre e Esclarecido/normas , Setor Público , Sujeitos da Pesquisa/psicologia , Medição de Risco , Doadores de Tecidos/psicologia
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