Fatores essenciais de segurança e eficácia dos produtos assistivos prioritários selecionados: revisão de escopo
DOI:
https://doi.org/10.11606/issn.2317-0190.v32i4a245841Palavras-chave:
Pessoas com Deficiência, Tecnologia Assistiva, Segurança, EficáciaResumo
Objetivo: Identificar os fatores essenciais de segurança e eficácia de produtos assistivos de modo a apoiar as ações governamentais de produção, dispensação e vigilância destes produtos. Método: O presente estudo foi comissionado pela Agência Nacional de Vigilância Sanitária com o propósito de apoiar a tomada de decisão informada por evidências científicas dentro do órgão. Dessa forma, por ser um produto técnico voltado à gestão, o qual necessita ser realizado em um curto período, optou-se pela escolha do método de resposta rápida. A pergunta de pesquisa foi desenvolvida por meio do acrônimo PCC (População, Conceito e Contexto). As buscas foram realizadas no Clinical Trials, International Clinical Trials Registry Platform (ICTRP) e Registro Brasileiro de Ensaios Clínicos (REBEC). Resultados: Foram identificados 539 registros nas três bases de dados incluídas: 491 no Clinical Trials, 29 no International Clinical Trials Registry Platform (ICTRP) e 19 no Registro Brasileiro de Ensaios Clínicos (REBEC). Dois registros foram excluídos por serem duplicatas. Ao final do processo de seleção, 485 foram excluídos por não atenderem aos critérios de elegibilidade. Dessa forma, 52 estudos foram incluídos na presente resposta rápida. Conclusão: Com base nos registros incluídos, foi possível identificar e categorizar 241 fatores de eficácia. Os resultados foram organizados em um menu de desfechos, e as informações descritas por tipo de produto e categoria. O mesmo foi feito para os fatores de segurança, os quais apareceram em um número muito menor de avaliações.
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Referências
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