Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database

CONTEXT AND OBJECTIVE: Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between stud...

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Detalles Bibliográficos
Autores: Ferreira, Christiane Alves [UNIFESP], Loureiro, Carlos Alfredo Salles [UNIFESP], Saconato, Humberto, Atallah, Álvaro Nagib [UNIFESP]
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2011
País:Brasil
Institución:Universidade Federal de São Paulo (UNIFESP)
Repositorio:Repositório Institucional da UNIFESP
Idioma:inglés
OAI Identifier:oai:repositorio.unifesp.br:11600/6339
Acceso en línea:http://dx.doi.org/10.1590/S1516-31802011000200006
http://repositorio.unifesp.br/handle/11600/6339
Access Level:acceso abierto
Palabra clave:Randomized controlled trial [publication type]
Selection bias
Double-blind method
Evidence-based dentistry
Empirical research
Ensaio clínico controlado aleatório
Viés de seleção
Método duplo-cego
Odontologia baseada em evidências
Pesquisa empírica
Descripción
Sumario:CONTEXT AND OBJECTIVE: Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. DESIGN AND SETTING: This was a methodology study conducted at Universidade Federal de São Paulo (UNIFESP) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. RESULTS: Out of the 4,503 articles classified, only 10 studies (0.22%) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. CONCLUSION: The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.