Limits to clinical trials in surgical areas

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Arquivos
art_DEMANGE_Limits_to_clinical_trials_in_surgical_areas_2011.PDF (49.24 KB)
Citações na Scopus
25
Tipo de produção
article
Data de publicação
2011
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
HOSPITAL CLINICAS, UNIV SAO PAULO
Autores
FREGNI, Felipe
Citação
CLINICS, v.66, n.1, p.159-161, 2011
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Randomized clinical trials are considered to be the gold standard of evidence-based medicine nowadays. However, it is important that we point out some limitations of randomized clinical trials relating to surgical interventions. There are limitations that affect the external and internal validity of many surgical study designs. Some limitations can be bypassed, but can make it more difficult for the study to be carried out. Other limitations cannot be bypassed. When it is intended to extrapolate the result of a randomized clinical trial, the premise is that the performed or to be performed intervention will be similar wherever applied and/or for every doctor using it. However, no matter how standardized the technique may be, the results are not similar for all surgeons, which implies a significant limitation to surgical randomized clinical trials concerning external validity. When considering the various limitations presented for performing surgical trials capable of generating scientific evidence within the patterns currently proposed in the evidence level classifications of medical publications, it is necessary to rethink whether those scientific evidence levels are similarly applicable to surgical works and to nonsurgical trials. We currently live in a time of supposed ""inferiority'' of surgical scientific works under the optics of the current quality criteria for a ""suitable'' clinical trial.
Palavras-chave
Clinical Trial, Surgery, Randomization, Blinding, Evidence Level
URI
https://observatorio.fm.usp.br/handle/OPI/23999
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Coleções
Artigos e Materiais de Revistas Científicas - HC/IOT
Artigos e Materiais de Revistas Científicas - LIM/41