Ethics and Bias in Clinical Trial Enrollment in Stroke.
Curr Cardiol Rep
; 21(6): 49, 2019 04 22.
Article
em En
| MEDLINE
| ID: mdl-31011843
ABSTRACT
PURPOSE OF REVIEW To familiarize the reader with ethical concerns and potential scientific bias in management and conduction of clinical stroke trials. RECENT FINDINGS:
The goal of clinical trials in stroke is to find effective interventions for stroke prevention, acute treatment, and rehabilitation and recovery. Acute trials must be designed in the context of the time-sensitivity of revascularization therapies. Standard ethical constraints apply. However, informed consent is hindered by tight time windows for reperfusion therapy and frequent cognitive impairment in patients. These might be mitigated by using visual decision aids. Non-traditional methods of consent such as utilization of surrogates, telemedicine, and exception from informed consent are critical for successful and unbiased conduction of stroke trials. Stroke centers must have an a priori plan for deciding which trial to offer multiple-trial eligible patients. Historic non-generalizability of stroke trials due to under-enrollment of women, racial minorities, and age extremes is improving, but adequate representative recruitment and retention require up-front planning and training. Stroke trials have become less biased and more representative in the last decades, but there is still research to be done to improve ethical and unbiased recruitment and retention.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Viés
/
Ensaios Clínicos como Assunto
/
Seleção de Pacientes
/
Acidente Vascular Cerebral
/
Consentimento Livre e Esclarecido
Tipo de estudo:
Prognostic_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article