Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos

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 qu...

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Autores principales:	Manterola,Carlos, Torres,Rodrigo, Burgos,Luis, Vial,Manuel, Pineda,Viviana
Lenguaje:	Spanish / Castilian
Publicado:	Sociedad Médica de Santiago 2006
Materias:	Controlled clinical trial Methods Stomach neoplasms, Antineoplastic Agents, Combined, Evidence-Based Medicine
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700017
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spelling	oai:scielo:S0034-988720060007000172006-08-29Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenosManterola,CarlosTorres,RodrigoBurgos,LuisVial,ManuelPineda,Viviana Controlled clinical trial Methods Stomach neoplasms, Antineoplastic Agents, Combined, Evidence-Based Medicine 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 and method: 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 theinfo:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.134 n.7 20062006-07-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700017es10.4067/S0034-98872006000700017
institution	Scielo Chile
collection	Scielo Chile
language	Spanish / Castilian
topic	Controlled clinical trial Methods Stomach neoplasms, Antineoplastic Agents, Combined, Evidence-Based Medicine
spellingShingle	Controlled clinical trial Methods Stomach neoplasms, Antineoplastic Agents, Combined, Evidence-Based Medicine Manterola,Carlos Torres,Rodrigo Burgos,Luis Vial,Manuel Pineda,Viviana Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos
description	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 and method: 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
author	Manterola,Carlos Torres,Rodrigo Burgos,Luis Vial,Manuel Pineda,Viviana
author_facet	Manterola,Carlos Torres,Rodrigo Burgos,Luis Vial,Manuel Pineda,Viviana
author_sort	Manterola,Carlos
title	Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos
title_short	Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos
title_full	Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos
title_fullStr	Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos
title_full_unstemmed	Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos
title_sort	calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos
publisher	Sociedad Médica de Santiago
publishDate	2006
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700017
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Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos

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