Qualidade dos ensaios clínicos aleatórios em cirurgia plástica
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Arquivos
Data
2001
Autores
Veiga Filho, Joel [UNIFESP]
Orientadores
Ferreira, Lydia Masako [UNIFESP]
Tipo
Dissertação de mestrado
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ISSN da Revista
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Qualidade dos ensaios clinicos aleatorios em Cirurgia Plastica. Contexto. A avaliacao da qualidade dos ensaios clinicos aleatorios e importante, pois a observacao dos erros e falhas nos permite evita-los no planejamento. conducao, analise e publicacao de futuros estudos. E e fundamental para se determinar o grau de confiabilidade dos resultados dos estudos publicados. Objetivo. Avaliar a qualidade dos ensaios clinicos aleatorios em Cirurgia Plastica. A hipotese testada foi a de que os estudos sao de ma qualidade. Tipo de estudo. Estudo descritivo com a avaliacao realizada por dois pesquisadores, de maneira independente, seguida de uma reuniao de consenso. Selecao da amostra. Ensaios clinicos aleatorios em Cirurgia Plastica, com sigilo de alocacao descrito adequadamente, realizado por/ou com a participacao de pelo menos um cirurgiao plastico, foram identificados atraves da busca eletronica nas bases de dados LILACS, MEDLINE, EMBASE e CCTR. Variavel estudada. Qualidade dos ensaios clinicos aleatorios, por meio da Lista de Delphi, de uma escala de qualidade (JADAD et al., 1996) e de cinco itens complementares. Resultados. Dos 139 estudos publicados como ensaios clinicos aleatorios, 63 por cento (88/139) nao descreveram o sigilo de alocacao, em 17 por cento (23/139) o sigilo de alocacao foi inadequado e 20 por cento (28/139) descreveram o sigilo de alocacao adequadamente. Dos 28 ensaios clinicos aleatorios, com sigilo de alocacao descrito adequadamente, 25 por cento nao descreveram a geracao da sequencia de alocacao, 82 por cento nao descreveram as perdas e exclusoes, 68 por cento nao descreveram se os grupos eram comparaveis, 50 por cento nao especificaram os criterios de inclusao e exclusao, 68 por cento nao apresentaram as medidas de variabilidade e as estimativas dos pontos para a variavel primaria, 61 por cento nao apresentaram uma analise por intencao de tratar. Na pontuacao pela escala de qualidade (JADAD et al., 1996), 71 por cento (20/28) receberam dois ou menos pontos. Conclusao. Os ensaios clinicos aleatorios em Cirurgia Plastica sao de ma qualidade
Quality of randomized clinical trials in Plastic Surgery. Context. The valuation of the quality of the randomized clinical trials is important since the observation of the mistakes and failures allows us to avoid them during planning, performing, analysis and publishing of future studies. It is fundamental in order to determine the reliability degree of the results of the published studies. Objective. To evaluate the quality of randomized clinical trials in Plastic Surgery. The hypothesis tested was the one stating that the studies are low quality ones. Type of study. Descriptive study with the valuation performed by two appraisers, in an independent way, followed by a consensus meeting. Study selection. Randomized clinical trials in Plastic Surgery, with allocation concealment suitably described, performed by/or with the participation of, at least, one plastic surgeon, were identified through electronic search in the basis of LILACS, EMBASE, MEDLINE and CCTR data. Studied variable. Quality of the randomized clinical trials, through Delphi List, through a quality scale (JADAD et al., 1996) and five complementary items. Results. From 139 studies published as randomized clinical trials, 63% (88/139) didn’t describe allocation concealment, in 17% (23/139) it was unsuited and 20% described it suitably. From 28 randomized clinical trials with allocation concealment suitably described, 25% didn’t describe the formation of the allocation sequence, 82% didn’t describe the loss and exclusion, 68% didn’t describe if the groups were comparable, 50% didn’t specify the inclusion and exclusion criteria, 68% didn’t present the variability measures and the points estimation for a primary variable, 61% didn’t present an analysis for a treating intention. In the punctuation by the quality scale (JADAD et al., 1996), 71% (20/28) got two or less points. Conclusion. The randomized clinical trials in Plastic Surgery are low quality ones.
Quality of randomized clinical trials in Plastic Surgery. Context. The valuation of the quality of the randomized clinical trials is important since the observation of the mistakes and failures allows us to avoid them during planning, performing, analysis and publishing of future studies. It is fundamental in order to determine the reliability degree of the results of the published studies. Objective. To evaluate the quality of randomized clinical trials in Plastic Surgery. The hypothesis tested was the one stating that the studies are low quality ones. Type of study. Descriptive study with the valuation performed by two appraisers, in an independent way, followed by a consensus meeting. Study selection. Randomized clinical trials in Plastic Surgery, with allocation concealment suitably described, performed by/or with the participation of, at least, one plastic surgeon, were identified through electronic search in the basis of LILACS, EMBASE, MEDLINE and CCTR data. Studied variable. Quality of the randomized clinical trials, through Delphi List, through a quality scale (JADAD et al., 1996) and five complementary items. Results. From 139 studies published as randomized clinical trials, 63% (88/139) didn’t describe allocation concealment, in 17% (23/139) it was unsuited and 20% described it suitably. From 28 randomized clinical trials with allocation concealment suitably described, 25% didn’t describe the formation of the allocation sequence, 82% didn’t describe the loss and exclusion, 68% didn’t describe if the groups were comparable, 50% didn’t specify the inclusion and exclusion criteria, 68% didn’t present the variability measures and the points estimation for a primary variable, 61% didn’t present an analysis for a treating intention. In the punctuation by the quality scale (JADAD et al., 1996), 71% (20/28) got two or less points. Conclusion. The randomized clinical trials in Plastic Surgery are low quality ones.
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Citação
VEIGA, Joel. Qualidade dos ensaios clínicos aleatórios em cirurgia plástica 2001. 104 f . Dissertação (Mestrado em Ciências) - Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, 2001.