Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.

Detalhes bibliográficos
Autor(a) principal: Moreira Júnior, Edson Duarte
Data de Publicação: 2001
Outros Autores: Stein, Z, Susser, Ezra
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/5512
Resumo: Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
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spelling Moreira Júnior, Edson DuarteStein, ZSusser, Ezra2012-09-11T21:12:17Z2012-09-11T21:12:17Z2001MOREIRA, E. D.; STEIN, Z.; SUSSER, E. Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals. Brazilian Journal of Medical Biological Research, v. 34, p. 11, p. 1441-6, Nov. 2001.0100-879Xhttps://www.arca.fiocruz.br/handle/icict/5512engReporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilColumbia University. Department of Psychiatry. New York, NY, United States of AmericaColumbia University. School of Public Health. Division of Epidemiology. New York, NY,United States of AmericaResults of subgroup analysis (SA) reported in randomized clinical trials (RCT) cannot be adequately interpreted without information about the methods used in the study design and the data analysis. Our aim was to show how often inaccurate or incomplete reports occur. First, we selected eight methodological aspects of SA on the basis of their importance to a reader in determining the confidence that should be placed in the author’s conclusions regarding such analysis. Then, we reviewed the current practice of reporting these methodological aspects of SA in clinical trials in four leading journals, i.e., the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet, and the American Journal of Public Health. Eight consecutive reports from each journal published after July 1, 1998 were included. Of the 32 trials surveyed, 17 (53%) had at least one SA. Overall, the proportion of RCT reporting a particular methodological aspect ranged from 23 to 94%. Information on whether the SA preceded/followed the analysis was reported in only 7 (41%) of the studies. Of the total possible number of items to be reported, NEJM, JAMA, Lancet and AJPH clearly mentioned 59, 67, 58 and 72%, respectively. We conclude that current reporting of SA in RCT is incomplete and inaccurate. The results of such SA may have harmful effects on treatment recommendations if accepted without judicious scrutiny. We recommend that editors improve the reporting of SA in RCT by giving authors a list of the important items to be reported.Subgroup analysesRandomized clinical trialsResearch designEpidemiological methodsEffect modificationPublicações Periódicas como Assunto/normasEnsaios Clínicos Controlados Aleatórios como Assunto/normasInterpretação Estatística de DadosHumanosEnsaios Clínicos Controlados Aleatórios como Assunto/métodosProjetos de Pesquisa/normasinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALMoreira ED Jr Reporting on methods of ....pdfMoreira ED Jr Reporting on methods of ....pdfapplication/pdf37039https://www.arca.fiocruz.br/bitstream/icict/5512/1/Moreira%20ED%20Jr%20%20Reporting%20on%20methods%20of%20....pdf2fb7c4e9518b874f5071b119d9a04071MD51LICENSElicense.txtlicense.txttext/plain; charset=utf-82008https://www.arca.fiocruz.br/bitstream/icict/5512/2/license.txt06db3f0df647fd9ddff657403bbe0ee2MD52TEXTMoreira ED Jr Reporting on methods of ....pdf.txtMoreira ED Jr Reporting on methods of ....pdf.txtExtracted texttext/plain21483https://www.arca.fiocruz.br/bitstream/icict/5512/5/Moreira%20ED%20Jr%20%20Reporting%20on%20methods%20of%20....pdf.txtf5c41aa515069dd82229e65e1cf0236cMD55THUMBNAILMoreira ED Jr Reporting on methods of ....pdf.jpgMoreira ED Jr Reporting on methods of ....pdf.jpgGenerated Thumbnailimage/jpeg2224https://www.arca.fiocruz.br/bitstream/icict/5512/4/Moreira%20ED%20Jr%20%20Reporting%20on%20methods%20of%20....pdf.jpg32406f577c7d3bf8a3cf2c00195defafMD54icict/55122023-03-15 14:33:01.572oai:www.arca.fiocruz.br:icict/5512TElDRU7Dh0EgREUgRElTVFJJQlVJw4fDg08gTsODTy1FWENMVVNJVkEKCkFvIGFzc2luYXIgZSBlbnRyZWdhciBlc3RhIGxpY2Vuw6dhLCBvL2EgU3IuL1NyYS4gKGF1dG9yIG91IGRldGVudG9yIGRvcyBkaXJlaXRvcyBkbyBhdXRvcik6CgpBbyBjb25jb3JkYXIgZSBhY2VpdGFyIGVzdGEgbGljZW7Dp2Egdm9jw6ogKGF1dG9yIG91IGRldGVudG9yIGRvcyBkaXJlaXRvcyBhdXRvcmFpcyk6CgphKSBEZWNsYXJhIHF1ZSBjb25oZWNlIGEgcG9sw610aWNhIGRlIGNvcHlyaWdodCBkYSBlZGl0b3JhIGRvIHNldSBkb2N1bWVudG8uCgpiKSBEZWNsYXJhIHF1ZSBjb25oZWNlIGUgYWNlaXRhIGFzIERpcmV0cml6ZXMgcGFyYSBvIFJlcG9zaXTDs3JpbyBJbnN0aXR1Y2lvbmFsIGRhIEZ1bmRhw6fDo28gT3N3YWxkbyBDcnV6IChGSU9DUlVaKS4KCmMpIENvbmNlZGUgw6AgRklPQ1JVWiBvIGRpcmVpdG8gbsOjby1leGNsdXNpdm8gZGUgYXJxdWl2YXIsIHJlcHJvZHV6aXIsIGNvbnZlcnRlciAoY29tbyBkZWZpbmlkbyBhIHNlZ3VpciksIGNvbXVuaWNhcgogCmUvb3UgZGlzdHJpYnVpciBubyBSZXBvc2l0w7NyaW8gZGEgRklPQ1JVWiwgbyBkb2N1bWVudG8gZW50cmVndWUgKGluY2x1aW5kbyBvIHJlc3Vtby9hYnN0cmFjdCkgZW0gZm9ybWF0byBkaWdpdGFsIG91IAoKcG9yIHF1YWxxdWVyIG91dHJvIG1laW8uCgpkKSBEZWNsYXJhIHF1ZSBhdXRvcml6YSBhIEZJT0NSVVogYSBhcnF1aXZhciBtYWlzIGRlIHVtYSBjw7NwaWEgZGVzdGUgZG9jdW1lbnRvIGUgY29udmVydMOqLWxvLCBzZW0gYWx0ZXJhciBvIHNldSBjb250ZcO6ZG8sIAoKcGFyYSBxdWFscXVlciBmb3JtYXRvIGRlIGFycXVpdm8sIG1laW8gb3Ugc3Vwb3J0ZSwgcGFyYSBlZmVpdG9zIGRlIHNlZ3VyYW7Dp2EsIHByZXNlcnZhw6fDo28gKGJhY2t1cCkgZSBhY2Vzc28uCgplKSBEZWNsYXJhIHF1ZSBvIGRvY3VtZW50byBzdWJtZXRpZG8gw6kgbyBzZXUgdHJhYmFsaG8gb3JpZ2luYWwsIGUgcXVlIGRldMOpbSBvIGRpcmVpdG8gZGUgY29uY2VkZXIgYSB0ZXJjZWlyb3Mgb3MgZGlyZWl0b3MgCgpjb250aWRvcyBuZXN0YSBsaWNlbsOnYS4gRGVjbGFyYSB0YW1iw6ltIHF1ZSBhIGVudHJlZ2EgZG8gZG9jdW1lbnRvIG7Do28gaW5mcmluZ2Ugb3MgZGlyZWl0b3MgZGUgcXVhbHF1ZXIgb3V0cmEgcGVzc29hIG91IGVudGlkYWRlLgoKZikgRGVjbGFyYSBxdWUsIG5vIGNhc28gZG8gZG9jdW1lbnRvIHN1Ym1ldGlkbyBjb250ZXIgbWF0ZXJpYWwgZG8gcXVhbCBuw6NvIGRldMOpbSBvcyBkaXJlaXRvcyBkZSBhdXRvciwgb2J0ZXZlIGEgYXV0b3JpemHDp8OjbyAKCmlycmVzdHJpdGEgZG8gcmVzcGVjdGl2byBkZXRlbnRvciBkZXNzZXMgZGlyZWl0b3MsIHBhcmEgY2VkZXIgYSBGSU9DUlVaIG9zIGRpcmVpdG9zIHJlcXVlcmlkb3MgcG9yIGVzdGEgTGljZW7Dp2EgZSBhdXRvcml6YXIgYSAKCnV0aWxpesOhLWxvcyBsZWdhbG1lbnRlLiBEZWNsYXJhIHRhbWLDqW0gcXVlIGVzc2UgbWF0ZXJpYWwgY3Vqb3MgZGlyZWl0b3Mgc8OjbyBkZSB0ZXJjZWlyb3MgZXN0w6EgY2xhcmFtZW50ZSBpZGVudGlmaWNhZG8gZSByZWNvbmhlY2lkbyAKCm5vIHRleHRvIG91IGNvbnRlw7pkbyBkbyBkb2N1bWVudG8gZW50cmVndWUuCgpnKSBTRSBPIERPQ1VNRU5UTyBFTlRSRUdVRSDDiSBCQVNFQURPIEVNIFRSQUJBTEhPIEZJTkFOQ0lBRE8gT1UgQVBPSUFETyBQT1IgT1VUUkEgSU5TVElUVUnDh8ODTyBRVUUgTsODTyBBIEZJT0NSVVosIERFQ0xBUkEgUVVFIENVTVBSSVUgCgpRVUFJU1FVRVIgT0JSSUdBw4fDlUVTIEVYSUdJREFTIFBFTE8gUkVTUEVDVElWTyBDT05UUkFUTyBPVSBBQ09SRE8uIEEgRklPQ1JVWiBpZGVudGlmaWNhcsOhIGNsYXJhbWVudGUgbyhzKSBub21lKHMpIGRvKHMpIGF1dG9yKGVzKSBkb3MgCgpkaXJlaXRvcyBkbyBkb2N1bWVudG8gZW50cmVndWUgZSBuw6NvIGZhcsOhIHF1YWxxdWVyIGFsdGVyYcOnw6NvLCBwYXJhIGFsw6ltIGRvIHByZXZpc3RvIG5hIGFsw61uZWEgYykuCg==Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-03-15T17:33:01Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.
title Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.
spellingShingle Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.
Moreira Júnior, Edson Duarte
Subgroup analyses
Randomized clinical trials
Research design
Epidemiological methods
Effect modification
Publicações Periódicas como Assunto/normas
Ensaios Clínicos Controlados Aleatórios como Assunto/normas
Interpretação Estatística de Dados
Humanos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
Projetos de Pesquisa/normas
title_short Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.
title_full Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.
title_fullStr Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.
title_full_unstemmed Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.
title_sort Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.
author Moreira Júnior, Edson Duarte
author_facet Moreira Júnior, Edson Duarte
Stein, Z
Susser, Ezra
author_role author
author2 Stein, Z
Susser, Ezra
author2_role author
author
dc.contributor.author.fl_str_mv Moreira Júnior, Edson Duarte
Stein, Z
Susser, Ezra
dc.subject.en.pt_BR.fl_str_mv Subgroup analyses
Randomized clinical trials
Research design
Epidemiological methods
Effect modification
topic Subgroup analyses
Randomized clinical trials
Research design
Epidemiological methods
Effect modification
Publicações Periódicas como Assunto/normas
Ensaios Clínicos Controlados Aleatórios como Assunto/normas
Interpretação Estatística de Dados
Humanos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
Projetos de Pesquisa/normas
dc.subject.decs.pt_BR.fl_str_mv Publicações Periódicas como Assunto/normas
Ensaios Clínicos Controlados Aleatórios como Assunto/normas
Interpretação Estatística de Dados
Humanos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
Projetos de Pesquisa/normas
description Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
publishDate 2001
dc.date.issued.fl_str_mv 2001
dc.date.accessioned.fl_str_mv 2012-09-11T21:12:17Z
dc.date.available.fl_str_mv 2012-09-11T21:12:17Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.citation.fl_str_mv MOREIRA, E. D.; STEIN, Z.; SUSSER, E. Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals. Brazilian Journal of Medical Biological Research, v. 34, p. 11, p. 1441-6, Nov. 2001.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/5512
dc.identifier.issn.none.fl_str_mv 0100-879X
identifier_str_mv MOREIRA, E. D.; STEIN, Z.; SUSSER, E. Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals. Brazilian Journal of Medical Biological Research, v. 34, p. 11, p. 1441-6, Nov. 2001.
0100-879X
url https://www.arca.fiocruz.br/handle/icict/5512
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