What question did this study set out to answer?

To expand the CONSORT statement to improve the quality, completeness, and transparency of harms-related data reporting in randomized controlled trials.

November 16, 2004Annals of Internal Medicine

Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

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Authors

JIJohn P. A. Ioannidis

Discussion

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Overview

Consensus guideline introduces 10 recommendations for reporting harms in randomized trials, highlighting the need for transparent safety data alongside trial efficacy results.

Key Points

To expand the CONSORT statement to improve the quality, completeness, and transparency of harms-related data reporting in randomized controlled trials.
Convened an international panel of CONSORT Group members, journal editors, and scientists in May 2003 in Montebello, Canada.
Evaluated current deficits in adverse event reporting and expanded the standard 22-item CONSORT checklist to address safety evaluation.
Formulated 10 new harms-related recommendations integrated into the standard CONSORT framework.
Provided explanatory text and practical examples to guide researchers in properly describing adverse events, safety analyses, and trial participant withdrawals.

Cite This Study

John P. A. Ioannidis (2004) studied this question.

synapsesocial.com/papers/6a7cccf4e7df423ee14c7fd7 https://doi.org/10.7326/0003-4819-141-10-200411160-00009

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November 16, 2004Annals of Internal Medicine

Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

View Full Paper

Ask AI

Bookmark

Authors

JIJohn P. A. Ioannidis

Discussion

Member takes

Overview

Consensus guideline introduces 10 recommendations for reporting harms in randomized trials, highlighting the need for transparent safety data alongside trial efficacy results.

Key Points

To expand the CONSORT statement to improve the quality, completeness, and transparency of harms-related data reporting in randomized controlled trials.
Convened an international panel of CONSORT Group members, journal editors, and scientists in May 2003 in Montebello, Canada.
Evaluated current deficits in adverse event reporting and expanded the standard 22-item CONSORT checklist to address safety evaluation.
Formulated 10 new harms-related recommendations integrated into the standard CONSORT framework.
Provided explanatory text and practical examples to guide researchers in properly describing adverse events, safety analyses, and trial participant withdrawals.

Cite This Study

John P. A. Ioannidis (2004) studied this question.

synapsesocial.com/papers/6a7cccf4e7df423ee14c7fd7 https://doi.org/10.7326/0003-4819-141-10-200411160-00009

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