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1.
Nat Commun ; 12(1): 801, 2021 02 05.
Artigo em Inglês | MEDLINE | ID: mdl-33547324

RESUMO

Most trials do not release interim summaries on efficacy and toxicity of the experimental treatments being tested, with this information only released to the public after the trial has ended. While early release of clinical trial data to physicians and patients can inform enrollment decision making, it may also affect key operating characteristics of the trial, statistical validity and trial duration. We investigate the public release of early efficacy and toxicity results, during ongoing clinical studies, to better inform patients about their enrollment options. We use simulation models of phase II glioblastoma (GBM) clinical trials in which early efficacy and toxicity estimates are periodically released accordingly to a pre-specified protocol. Patients can use the reported interim efficacy and toxicity information, with the support of physicians, to decide which trial to enroll in. We describe potential effects on various operating characteristics, including the study duration, selection bias and power.


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias Encefálicas/psicologia , Drogas em Investigação/uso terapêutico , Glioblastoma/psicologia , Disseminação de Informação/métodos , Modelagem Computacional Específica para o Paciente , Neoplasias Encefálicas/tratamento farmacológico , Neoplasias Encefálicas/mortalidade , Neoplasias Encefálicas/patologia , Ensaios Clínicos como Assunto , Tomada de Decisões , Glioblastoma/tratamento farmacológico , Glioblastoma/mortalidade , Glioblastoma/patologia , Humanos , Disseminação de Informação/ética , Segurança do Paciente , Seleção de Pacientes/ética , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento
3.
Nurs Res ; 70(1): 67-71, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-32991528

RESUMO

BACKGROUND: Social media platforms are useful for recruiting hard-to-reach populations, such as caregivers of children with cancer, for research. However, there are unique ethical considerations in using social media. OBJECTIVES: The aim of the study was to describe the methods used to recruit hard-to-reach caregivers (parents of children with cancer) for research and related ethical considerations. METHODS: We used The Belmont Report tenets (respect for persons, beneficence, and justice) as a guiding framework to identify issues relevant to social media recruitment of hard-to-reach populations and to describe how we addressed these issues in our study. RESULTS: We engaged leaders of two online communities that offer peer support for caregivers of children with cancer to help with recruitment to our study on financial effect of pediatric cancer. We identified issues in using social media for recruiting hard-to-reach populations in alignment with The Belmont Report, including risk for subject selection bias, privacy rights, protecting identity of participants, data security issues, and access to research. We addressed issues by deliberate study design decisions and engagement with online community advocates. DISCUSSION: Using social media to recruit hard-to-reach populations may be a successful way to engage them in research. Although researchers may remain compliant with the institutional review board of their facilities and are faithful to the tenets of The Belmont Report, unanticipated ethical issues may arise directly or indirectly as a result of using social media. This article identifies these issues and provides suggestions for dealing with them.


Assuntos
Cuidadores/ética , Cuidadores/estatística & dados numéricos , Crianças com Deficiência/estatística & dados numéricos , Neoplasias/enfermagem , Pesquisa em Enfermagem/métodos , Seleção de Pacientes/ética , Mídias Sociais/ética , Adolescente , Adulto , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Projetos de Pesquisa , Mídias Sociais/estatística & dados numéricos
4.
Vaccine ; 39(4): 633-640, 2021 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-33341309

RESUMO

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.


Assuntos
Pesquisa Biomédica/ética , /prevenção & controle , Experimentação Humana/ética , Consentimento Livre e Esclarecido/ética , /patogenicidade , Antivirais/administração & dosagem , /imunologia , Comitês de Ética em Pesquisa/organização & administração , Voluntários Saudáveis , Experimentação Humana/legislação & jurisprudência , Humanos , Seleção de Pacientes/ética , Vacinação/ética , Organização Mundial da Saúde
5.
Lancet Glob Health ; 9(3): e366-e371, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33340453

RESUMO

Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.


Assuntos
/tratamento farmacológico , Ensaios Clínicos como Assunto/normas , Seleção de Pacientes/ética , Complicações Infecciosas na Gravidez/tratamento farmacológico , Ensaios Clínicos como Assunto/ética , Definição da Elegibilidade , Feminino , Humanos , Gravidez
7.
PLoS One ; 15(12): e0243562, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33382745

RESUMO

BACKGROUND: Recruitment of individuals with rare diseases for studies of real-world patient-reported outcomes is limited by small base populations. Myeloproliferative neoplasms (MPNs) are a group of rare, chronic, hematologic malignancies. In this study, recruitment strategies and geographic representativeness from the Living with MPNs survey are reported. METHODS: The Living with MPNs online cross-sectional survey was conducted between April and November 2016. Individuals 18 to 70 years of age living in the United States and diagnosed with an MPN were eligible to participate. Recruitment approaches included direct contact via emails and postcards; posts on MPN-focused social media and patient advocacy websites; postcard mailings to doctors' offices; and advertisements on medical websites, Google, and Facebook. Geographic representativeness was assessed based on the number of survey respondents living in each state or the District of Columbia and by the number of survey respondents per 10 million residents. RESULTS: A total of 904 respondents with MPNs completed the survey. The recruitment method yielding the greatest number of respondents was advertisements on MPN-focused social media (47.6% of respondents), followed by emails (35.1%) and postcards (13.9%) sent through MPN advocacy groups. Home state information was provided by 775 respondents from 46 states (range of respondents per state, 1-89). The number of respondents per 10 million residents in the 46 states with respondents ranged from 12.1 to 52.7. CONCLUSIONS: Recruitment using social media and communications through patient groups and advocacy organizations are effective in obtaining geographically representative samples of individuals with MPNs in the United States. These approaches may also be effective in other rare diseases.


Assuntos
Transtornos Mieloproliferativos/psicologia , Seleção de Pacientes/ética , Doenças Raras/psicologia , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/psicologia , Medidas de Resultados Relatados pelo Paciente , Doenças Raras/fisiopatologia , Mídias Sociais , Inquéritos e Questionários , Estados Unidos
8.
Bull Hosp Jt Dis (2013) ; 78(4): 221-226, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33207142

RESUMO

The COVID-19 pandemic has had unprecedented impact on the United States health care system. One of the consider-ations was the decision to halt elective orthopedic surgery to preserve consumption of scarce resources. However, as the number of COVID-19 cases decrease, there will be discus-sions regarding the modality of resuming elective orthopedic surgery. Ethical considerations will come to the forefront in terms of determining the best course of action, patient selection, resource rationing, and financial implications. These factors will be examined through the lens of the four tenets of bioethics, beneficence, maleficence, autonomy, and justice, to elucidate the best approach in ethically manag-ing elective orthopedic surgery during a global pandemic.


Assuntos
Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Procedimentos Cirúrgicos Eletivos/ética , Controle de Infecções/organização & administração , Procedimentos Ortopédicos/ética , Pandemias/prevenção & controle , Seleção de Pacientes/ética , Pneumonia Viral/prevenção & controle , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/transmissão , Humanos , Pneumonia Viral/epidemiologia , Pneumonia Viral/transmissão , Estados Unidos
10.
S Afr Med J ; 110(7): 625-628, 2020 06 17.
Artigo em Inglês | MEDLINE | ID: mdl-32880336

RESUMO

The COVID-19 pandemic has brought discussions around the appropriate and fair rationing of scare resources to the forefront. This is of special importance in a country such as South Africa (SA), where scarce resources interface with high levels of need. A large proportion of the SA population has risk factors associated with worse COVID-19 outcomes. Many people are also potentially medically and socially vulnerable secondary to the high levels of infection with HIV and tuberculosis (TB) in the country. This is the second of two articles. The first examined the clinical evidence regarding the inclusion of HIV and TB as comorbidities relevant to intensive care unit (ICU) admission triage criteria. Given the fact that patients with HIV or TB may potentially be excluded from admission to an ICU on the basis of an assumption of lack of clinical suitability for critical care, in this article we explore the ethicolegal implications of limiting ICU access of persons living with HIV or TB. We argue that all allocation and rationing decisions must be in terms of SA law, which prohibits unfair discrimination. In addition, ethical decision-making demands accurate and evidence-based strategies for the fair distribution of limited resources. Rationing decisions and processes should be fair and based on visible and consistent criteria that can be subjected to objective scrutiny, with the ultimate aim of ensuring accountability, equity and fairness.


Assuntos
Infecções por Coronavirus , Infecções por HIV/epidemiologia , Alocação de Recursos para a Atenção à Saúde/métodos , Unidades de Terapia Intensiva , Pandemias , Seleção de Pacientes/ética , Pneumonia Viral , Alocação de Recursos , Triagem , Tuberculose/epidemiologia , Betacoronavirus/isolamento & purificação , Coinfecção , Infecções por Coronavirus/economia , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Necessidades e Demandas de Serviços de Saúde/organização & administração , Humanos , Unidades de Terapia Intensiva/economia , Unidades de Terapia Intensiva/normas , Pandemias/economia , Pneumonia Viral/economia , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Alocação de Recursos/ética , Alocação de Recursos/legislação & jurisprudência , África do Sul/epidemiologia , Triagem/economia , Triagem/ética , Triagem/legislação & jurisprudência
12.
AIDS Patient Care STDS ; 34(9): 399-416, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32931317

RESUMO

HIV disproportionately impacts US racial and ethnic minorities but they participate in treatment and vaccine clinical trials at a lower rate than whites. To summarize barriers and facilitators to this participation we conducted a scoping review of the literature guided by the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. Studies published from January 2007 and September 2019 were reviewed. Thirty-one articles were identified from an initial pool of 325 records using three coders. All records were then assessed for barriers and facilitators and summarized. Results indicate that while racial and ethnic minority participation in these trials has increased over the past 10 years, rates still do not proportionately reflect their burden of HIV infection. While many of the barriers mirror those found in other disease clinical trials (e.g., cancer), HIV stigma is a unique and important barrier to participating in HIV clinical trials. Recommendations to improve recruitment and retention of racial and ethnic minorities include training health care providers on the importance of recruiting diverse participants, creating interdisciplinary research teams that better represent who is being recruited, and providing culturally competent trial designs. Despite the knowledge of how to better recruit racial and ethnic minorities, few interventions have been documented using these strategies. Based on the findings of this review, we recommend that future clinical trials engage community stakeholders in all stages of the research process through community-based participatory research approaches and promote culturally and linguistically appropriate recruitment and retention strategies for marginalized populations overly impacted by HIV.


Assuntos
Ensaios Clínicos como Assunto , Grupos Étnicos , Infecções por HIV/tratamento farmacológico , Grupos Minoritários , Participação do Paciente/psicologia , Grupos de Populações Continentais , Infecções por HIV/etnologia , Infecções por HIV/psicologia , Humanos , Grupos Minoritários/estatística & dados numéricos , Seleção de Pacientes/ética , Vacinas/administração & dosagem
13.
Rev. esp. med. legal ; 46(3): 119-126, jul.-sept. 2020.
Artigo em Espanhol | IBECS | ID: ibc-192313

RESUMO

La pandemia por COVID-19 ha suscitado problemas éticos y médico-legales, entre los que destaca la asignación equitativa de recursos sanitarios, sobre todo en relación a la priorización de pacientes y el racionamiento de recursos. El establecimiento de prioridades está siempre presente en los sistemas sanitarios y depende de la teoría de justicia aplicable en cada sociedad. El racionamiento de recursos ha sido necesario en la pandemia por COVID-19, por lo que se han publicado documentos de consenso para la toma de decisiones sustentadas en cuatro valores éticos fundamentales: maximización de los beneficios, tratar a las personas igualmente, contribuir en la creación de valor social y dar prioridad a la situación más grave. De ellos derivan recomendaciones específicas: maximizar beneficios; priorizar a los trabajadores de la salud; no priorizar la asistencia por orden de llegada; ser sensible a la evidencia científica; reconocer la participación en la investigación y aplicar los mismos principios a los pacientes COVID-19 que a los no-COVID-19


The COVID-19 pandemic has raised ethical and medico-legal problems, which include the equitable allocation of health resources, especially in relation to the prioritization of patients and the rationing of resources. Priority setting is always present in healthcare systems and depends on the theory of justice applicable in each society. Resource rationing has been necessary in the COVID-19 pandemic, and therefore consensus documents have been published for decision-making based on four fundamental ethical values: maximization of benefits, treating people equally, contributing to creating social value and giving priority to the worst off, from which specific recommendations derive: maximize benefits; prioritize health workers; do not prioritize attendance on a first-come, first-served basis; be sensitive to scientific evidence; recognize participation in research and apply the same principles to COVID-19 patients as to non-COVID-19 patients


Assuntos
Humanos , Valor da Vida , Administração dos Cuidados ao Paciente/legislação & jurisprudência , Seleção de Pacientes/ética , Infecções por Coronavirus , Cuidados Paliativos na Terminalidade da Vida/ética , Cuidados para Prolongar a Vida/ética , Pandemias/legislação & jurisprudência , Tomada de Decisões/ética , Temas Bioéticos , Revisão da Utilização de Recursos de Saúde/legislação & jurisprudência , Alocação de Recursos/legislação & jurisprudência , Recusa do Médico a Tratar/ética , Recusa do Médico a Tratar/legislação & jurisprudência
18.
PLoS One ; 15(6): e0234309, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32520955

RESUMO

A lack of data on patient choices and outcomes at the time of pre-dialysis planning limits meaningful shared decision making, particularly in older frailer patients. In this large retrospective cohort study of patients aged over 70 seen by the pre-dialysis clinic (2004-2016) of a large single centre in the United Kingdom (1,216 patients), age, sex, comorbidity, poverty and frailty were used to predict choice of renal replacement therapy (RRT) over maximum conservative management (MCM). The impact of patient choice of RRT versus MCM was used to predict survival from the time of choice using multivariable Cox proportional hazards regression. Older age, female sex, greater poverty and greater frailty were associated with choosing MCM, whilst comorbidity had no significant impact on choice. At 5 years of follow up, 49% of all patients had died without receiving RRT. Over 70% of the patients choosing MCM died with better kidney function than the median level at which those starting RRT initiated treatment. Frailty and age were better predictors of survival than comorbidity and in patients with at least moderate frailty, RRT offered no survival benefit over MCM. In conclusion, analysing outcomes from the time of choice may improve shared decision making. Frailty should be routinely assessed and collected and further work may help predict which patients are unlikely to survive or progress to end stage renal disease and may not need to be burdened with making a pre-dialysis choice.


Assuntos
Nefropatias/psicologia , Seleção de Pacientes/ética , Terapia de Substituição Renal/ética , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Comorbidade , Tratamento Conservador , Feminino , Humanos , Rim/patologia , Falência Renal Crônica/terapia , Masculino , Diálise Renal/métodos , Terapia de Substituição Renal/mortalidade , Estudos Retrospectivos , Reino Unido
19.
Scand J Trauma Resusc Emerg Med ; 28(1): 51, 2020 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-32513204

RESUMO

BACKGROUND: Clinical research in severely ill or injured patients is required to improve healthcare but may be challenging to perform in practice. The aim of this study was to analyse barriers and challenges in the process of including critically ill patients in clinical studies. METHODS: Data from critically ill patients considered for inclusion in an observational study of venous thromboembolism in Norway were analysed. This included quantitative and qualitative information from the screening log, consent forms and research notes. RESULTS: Among 279 eligible critically ill patients, 204 (73%) were omitted from the study due to challenges and barriers in the inclusion process. Reasons for omission were categorised as practical in 133 (65%), medical in 31 (15%), and legal or ethical in 40 (20%) of the patients. Among 70 included patients, 29 (41%) consents were from patients and 41 (59%) from their next of kin. Several challenges were described herein; these included whether patients were competent to give consent, and which next of kin that should represent the patient. Furthermore, some included patients were unable to recall what they have consented, and some appeared unable to separate research from treatment. CONCLUSIONS: Barriers and challenges in the inclusion process led to the omission of near three out of four eligible patients. This analysis provided information about where the problem resides and may be solved. The majority of challenges among included patients were related to issues of autonomy and validity of consent. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03405766).


Assuntos
Estado Terminal/terapia , Dalteparina/uso terapêutico , Fibrinolíticos/uso terapêutico , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Seleção de Pacientes/ética , Adulto , Feminino , Humanos , Masculino , Noruega
20.
J Heart Lung Transplant ; 39(7): 619-626, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32505492

RESUMO

To understand the challenges for thoracic transplantation and mechanical circulatory support during the current coronavirus disease 2019 pandemic, we propose separating the effects of the pandemic into 5 distinct stages from a healthcare system perspective. We discuss how the classical ethical principles of utility, justice, and efficiency may need to be adapted, and we give specific recommendations for thoracic transplantation and mechanical circulatory support centers to balance their clinical decisions and strategies for advanced heart and lung disease during the current pandemic.


Assuntos
Circulação Assistida/ética , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Acesso aos Serviços de Saúde/ética , Transplante de Coração/ética , Transplante de Pulmão/ética , Pneumonia Viral/epidemiologia , Humanos , Pandemias , Seleção de Pacientes/ética
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