Trials publishes first extended protocol

Yesterday, Trials published a substantially extended version of Zinkstok and colleagues’ protocol for a randomized controlled trial of a new combination therapy for ischemic stoke, which was originally published in Cerebrovascular Diseases. In this extended protocol, the authors expand upon key methodological elements of their study, giving full details of enrollment procedures, outcome measures and planned statistical analyses as well as providing example data collection forms as additional files.

A
randomised controlled trial of antiplatelet therapy in combination with
Rt-PA thrombolysis in ischemic stroke: rationale and design of the
ARTIS-Trial

S M Zinkstok, M Vermeulen, J Stam, R J de Haan, Y B Roos, Artis Study group
Trials 2010, 11:51 (12 May 2010)

Transparency and completeness in published protocols helps to maintain an accurate record of clinical trials that have been undertaken and allows for the critical evaluation of published results papers. Similarly, complete disclosure of trial results in line with reporting guidelines is essential if we are to prevent bias in the scientific literature. As part of our commitment to improving the performance and reporting of clinical trials – and given that the space available for publication in the journal is almost limitless – Trials actively encourages the submission of extended protocols and expanded reports of completed trials, provided that they make a significant additional contribution to the scientific record.

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