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The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improveme...

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Autores principales: Moher, David, Schulz, Kenneth F, Altman, Douglas G
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2001
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC32201/
https://www.ncbi.nlm.nih.gov/pubmed/11336663
http://dx.doi.org/10.1186/1471-2288-1-2
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author Moher, David
Schulz, Kenneth F
Altman, Douglas G
author_facet Moher, David
Schulz, Kenneth F
Altman, Douglas G
author_sort Moher, David
collection PubMed
description To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results and Discussion. The revised checklist includes 22-items selected because empirical evidence indicates that not reporting the information is associated with biasedestimates of treatment effect or the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
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spelling pubmed-322012001-06-05 The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials Moher, David Schulz, Kenneth F Altman, Douglas G BMC Med Res Methodol Research Article To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results and Discussion. The revised checklist includes 22-items selected because empirical evidence indicates that not reporting the information is associated with biasedestimates of treatment effect or the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results. BioMed Central 2001-04-20 /pmc/articles/PMC32201/ /pubmed/11336663 http://dx.doi.org/10.1186/1471-2288-1-2 Text en Copyright © 2001 Moher et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.
spellingShingle Research Article
Moher, David
Schulz, Kenneth F
Altman, Douglas G
The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
title The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
title_full The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
title_fullStr The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
title_full_unstemmed The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
title_short The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
title_sort consort statement: revised recommendations for improving the quality of reports of parallel group randomized trials
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC32201/
https://www.ncbi.nlm.nih.gov/pubmed/11336663
http://dx.doi.org/10.1186/1471-2288-1-2
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