Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.

Adequate reporting of randomized, controlled trials (RCTs) is necessary to allow accurate critical appraisal of the validity and applicability of the results. The CONSORT (Consolidated Standards of Reporting Trials) Statement, a 22-item checklist and flow diagram, is intended to address this problem...

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Main Authors: Boutron, I, Moher, D, Altman, D, Schulz, K, Ravaud, P
Format: Journal article
Language:English
Published: 2008
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author Boutron, I
Moher, D
Altman, D
Schulz, K
Ravaud, P
author_facet Boutron, I
Moher, D
Altman, D
Schulz, K
Ravaud, P
author_sort Boutron, I
collection OXFORD
description Adequate reporting of randomized, controlled trials (RCTs) is necessary to allow accurate critical appraisal of the validity and applicability of the results. The CONSORT (Consolidated Standards of Reporting Trials) Statement, a 22-item checklist and flow diagram, is intended to address this problem by improving the reporting of RCTs. However, some specific issues that apply to trials of nonpharmacologic treatments (for example, surgery, technical interventions, devices, rehabilitation, psychotherapy, and behavioral intervention) are not specifically addressed in the CONSORT Statement. Furthermore, considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement. Therefore, the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments. A consensus meeting of 33 experts was organized in Paris, France, in February 2006, to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments. The participants extended 11 items from the CONSORT Statement, added 1 item, and developed a modified flow diagram. To allow adequate understanding and implementation of the CONSORT extension, the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting. This extension, in conjunction with the main CONSORT Statement and other CONSORT extensions, should help to improve the reporting of RCTs performed in this field.
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spelling oxford-uuid:a5ba7899-11df-4bb6-b93a-cc1d6f73a0492022-03-27T02:42:21ZExtending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:a5ba7899-11df-4bb6-b93a-cc1d6f73a049EnglishSymplectic Elements at Oxford2008Boutron, IMoher, DAltman, DSchulz, KRavaud, PAdequate reporting of randomized, controlled trials (RCTs) is necessary to allow accurate critical appraisal of the validity and applicability of the results. The CONSORT (Consolidated Standards of Reporting Trials) Statement, a 22-item checklist and flow diagram, is intended to address this problem by improving the reporting of RCTs. However, some specific issues that apply to trials of nonpharmacologic treatments (for example, surgery, technical interventions, devices, rehabilitation, psychotherapy, and behavioral intervention) are not specifically addressed in the CONSORT Statement. Furthermore, considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement. Therefore, the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments. A consensus meeting of 33 experts was organized in Paris, France, in February 2006, to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments. The participants extended 11 items from the CONSORT Statement, added 1 item, and developed a modified flow diagram. To allow adequate understanding and implementation of the CONSORT extension, the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting. This extension, in conjunction with the main CONSORT Statement and other CONSORT extensions, should help to improve the reporting of RCTs performed in this field.
spellingShingle Boutron, I
Moher, D
Altman, D
Schulz, K
Ravaud, P
Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
title Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
title_full Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
title_fullStr Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
title_full_unstemmed Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
title_short Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
title_sort extending the consort statement to randomized trials of nonpharmacologic treatment explanation and elaboration
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