ABSTRACT
OBJECTIVE: To develop and validate the content of workflows for trial participants care in a clinical research center during the Covid-19 pandemic. METHOD: development study by consensus of experts carried out from March to July 2020 in southern Brazil. The flowcharts were developed following literature and validated by specialists considering comprehensiveness, clarity and pertinence, obtaining a 100% agreement index on each item of the developed instruments. The study was approved by the Ethics Committee of the institution. RESULTS: two flowcharts of care were elaborated and validated: "Flow diagram to conduct protocols with research participant " and "Flow diagram in protocols with research participant with suspected or confirmed COVID-19 infection"; which describes activities to ensure continuity of care. FINAL CONSIDERATIONS: a routine workflow can promote the continuity and safety of clinical research protocols. It is expected that the adopted flowcharts in this study can guide other institutions with a similar research profile.
Subject(s)
COVID-19 , Clinical Trials as Topic/methods , Pandemics , Practice Guidelines as Topic , Workflow , COVID-19/epidemiology , COVID-19/prevention & control , Humans , Reproducibility of Results , Research Personnel , SARS-CoV-2ABSTRACT
Objective: To develop and validate the content of care flowcharts in a Clinical Research Center during the Covid-19 pandemic.Method: development study by consensus of experts carried out from March to July/2020 in southern Brazil. The flowcharts were developed from the literature and validated by specialists considering comprehensiveness, clarity and pertinence, obtaining a 100% agreement index, on each item of the developed instruments. The study was approved by the Ethics Committee of the institution.Results: two flowcharts of care were elaborated and validated: General care to the research participant (without suspicion of Covid-19) and assistance to the research participant with suspicion or Covid-19 confirmed; which describe activities to ensure continuity of care. Conclusion: flowcharts can promote the continuity and security of research protocols. It is expected that the flows adopted can guide other institutions with a similar profile of care.
Objetivo: Desarrollar y validar el contenido de diagramas de flujo de atención en Centro de Investigación Clínica durante la pandemia de Covid-19.Método: Estudio de desarrollo por consenso de expertos realizado de marzo a julio / 2020 en el sur de Brasil. En el estudio participaron doce expertos de diferentes áreas. Los diagramas de flujo fueron desarrollados a partir de la literatura y validados por especialistas considerando la amplitud, claridad y pertinencia, obteniendo un índice de concordancia del 100%, en cada ítem de los instrumentos desarrollados. Estudio fue aprobado por el Comité de ética de la institución.Resultados: Se elaboraron y validaron dos diagramas de atención: Atención general al participante en la investigación (sin sospecha de Covid-19) y asistencia al participante en investigación con sospecha o Covid-19 confirmada; que describen actividades para asegurar la continuidad de la atención.Conclusión: Los diagramas de flujo pueden promover la continuidad y seguridad de los protocolos de investigación. Se espera que los flujos adoptados puedan guiar a otras instituciones con un perfil similar de atención.
Objetivo: Desenvolver e validar o conteúdo de fluxogramas de atendimento em Centro de Pesquisa Clínica durante a pandemia Covid-19 Método: Estudo de desenvolvimento e validação por consenso de especialistas realizado de março a julho/2020 no sul do Brasil. Participaram do estudo 12 especialistas de diferentes áreas. Os fluxogramas foram desenvolvidos a partir da literatura e validados por especialistas considerando abrangência, clareza e pertinência, obtendo-se índice de concordância de 100%, sobre cada item dos instrumentos desenvolvidos. Estudo aprovado no Comitê de Ética da instituição.Resultados: Construiu-se dois fluxogramas: "Atendimento geral ao participante de pesquisa (sem suspeita de Covid-19)" e "Atendimento ao participante de pesquisa com suspeita ou Covid-19 confirmado"; os quais descrevem atividades visando assegurar a continuidade do cuidado. Conclusão: os fluxogramas permitem que a continuidade e segurança dos protocolos de pesquisa sejam mantidos. Espera-se que os fluxos adotados possam nortear outras instituições com perfil semelhante de atendimento.
