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1.
J Am Med Inform Assoc ; 28(2): 377-383, 2021 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-33165614

RESUMO

Assuring the safety of both patients and healthcare workers (HCWs) in hospitals has been the primary focus of every healthcare organization during the COVID 19 pandemic. This article discusses the NIH Clinical Center's interdisciplinary approach to deploying an organizational Asymptomatic Staff Testing System.


Assuntos
Doenças Assintomáticas , Teste para COVID-19/métodos , COVID-19/diagnóstico , Registros Eletrônicos de Saúde , Pessoal de Saúde , Aplicações da Informática Médica , Vigilância em Saúde Pública/métodos , Humanos , Internet , National Institutes of Health (U.S.) , Software , Estados Unidos
2.
Contemp Clin Trials ; 48: 21-9, 2016 05.
Artigo em Inglês | MEDLINE | ID: mdl-27002223

RESUMO

Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings.


Assuntos
Lista de Checagem , Coleta de Dados/normas , Medidas de Resultados Relatados pelo Paciente , Pesquisadores , Pesquisa Biomédica , Ensaios Clínicos como Assunto , Humanos , Autorrelato
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