Differences between the real and the desired worlds in the results of clinical trials

• Autor(a) principal: Dib, Regina El
• Data de Publicação: 2015
• Outros Autores: Jorge, Eliane Chaves, Kamegasawa, Amélia, Daher, Solange Ramires, Spagnuolo, Regina Stella, Silva, Marise Pereira da, Braga, Gabriel Pereira, Volpato, Enilze, Módolo, Norma Sueli Pinheiro, Betini, Marluci, Valle, Adriana do, Corrêa, Ione, Bazan, Rodrigo, Almeida, Ricardo Augusto MB, Weber, Silke Anna Theresa, Molina, Silvana, Yoo, Hugo, Boas, Paulo Villas, Corrente, José Eduardo, Mathew, Joseph, Kapoor, Anil, Carvalho, Raíssa Pierri, Vital, Roberto Bezerra, Braz, Leandro Gobbo, Nascimento Junior, Paulo
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Clinics
• Texto Completo: https://www.revistas.usp.br/clinics/article/view/103927

OBJECTIVE:We refer to the effectiveness (known as pragmatic or real world) and efficacy (known as explanatory or desired or ideal world) of interventions. However, these terms seem to be randomly chosen by investigators who design clinical trials and do not always reflect the true purpose of the study. A pragmatic-explanatory continuum indicator summary tool was thus developed with the aim of identifying the characteristics of clinical trials that distinguish between effectiveness and efficacy issues. We verified whether clinical trials used the criteria proposed by the indicator summary tool, and we categorized these clinical trials according to a new classification.METHOD:A systematic survey of randomized clinical trials was performed. We added a score ranging from 0 (more efficacious) to 10 (more effective) to each domain of the indicator summary tool and proposed the following classifications: high efficacy (