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 improvem...

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Main Authors: Moher, D, Schulz, K, Altman, D
Format: Journal article
Language:English
Published: 2002
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author Moher, D
Schulz, K
Altman, D
author_facet Moher, D
Schulz, K
Altman, D
author_sort Moher, D
collection OXFORD
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 here 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 Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect, or because 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 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly shows 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 done an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trials conduct and to assess the validity of its results.
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spelling oxford-uuid:025a654c-d132-42f4-b8cb-6c796a260b8f2022-03-26T08:40:16ZThe consort statement: Revised recommendations for improving the quality of reports of parallel-group randomized trialsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:025a654c-d132-42f4-b8cb-6c796a260b8fEnglishSymplectic Elements at Oxford2002Moher, DSchulz, KAltman, DTo 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 here 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 Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect, or because 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 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly shows 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 done an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trials conduct and to assess the validity of its results.
spellingShingle Moher, D
Schulz, K
Altman, D
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
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