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Controversies |

Beyond CONSORT: Need for Improved Reporting Standards for Clinical Trials

Curtis L. Meinert, PhD
JAMA. 1998;279(18):1487-1489. doi:10.1001/jama.279.18.1487.
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THE INCREASING USE of trials as vehicles for choosing among treatments has fueled drives for standardizing the way trials are reported.15 These drives have been propelled by editors, frustrated readers, and meta-analysts desiring the same basic information and counts.

There is no doubt that all of these groups would benefit from better reporting of trials and by analyses subsumed under the heading analysis by treatment assignment or analysis by intention to treat.6 To that end, there are reasons to applaud the efforts of biomedical journals to support the Consolidated Standards of Reporting Trials (CONSORT) statement.1,2 Content suggestions and checklists are useful in preparing reports of trials.7 Hence, the CONSORT checklist is useful. A worthwhile addition to the list would be an item on treatment effects monitoring, since monitoring is part and parcel of most randomized trials.

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Progress through various stages of a trial, including flow of participants, withdrawals, and timing of primary and secondary outcome measures. The "R" indicates randomization. Reprinted with permission from Begg et al.1

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