Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos / Methodological quality of an article on the treatment of gastric cancer adopted as protocol by some Chilean hospitals
Rev. méd. Chile
;
134(7): 920-926, jul. 2006. ilus
Artículo
en Español
| LILACS
| ID: lil-434595
RESUMO
Background:
Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC.Aim:
To determine methodological quality and internal and external validity of the Macdonald study. Material andmethod:
Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology.Results:
The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis.Conclusion:
The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the study.
Texto completo:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Proyectos de Investigación
/
Neoplasias Gástricas
/
Guías de Práctica Clínica como Asunto
/
Medicina Basada en la Evidencia
/
Investigación Biomédica
Tipo de estudio:
Ensayo Clínico Controlado
/
Guía de Práctica Clínica
/
Estudio pronóstico
Límite:
Humanos
País/Región como asunto:
America del Sur
/
Chile
Idioma:
Español
Revista:
Rev. méd. Chile
Asunto de la revista:
Medicina
Año:
2006
Tipo del documento:
Artículo
País de afiliación:
Chile
Institución/País de afiliación:
Universidad de La Frontera/CL
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