CONSORT-EHEALTH: implementation of a checklist for authors and editors to improve reporting of web-based and mobile randomized controlled trials.

BACKGROUND

Randomized trials of web-based and mobile interventions pose very specific issues and challenges. A set of best practices on how to conduct and report such trials was recently summarized in the CONSORT-EHEALTH statement (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), published in August 2011 as draft and in December 2011 as journal article (V1.6.1). The purpose of this presentation is to review the results of the pilot implementation at the Journal of Medical Internet Research (JMIR), a leading eHealth journal, where reporting of trials in accordance with CONSORT-EHEALTH became mandatory in late 2011.

METHODS

Authors of all randomized trials submitted to JMIR were asked to complete an electronic questionnaire, which involved copying pertinent manuscript sections into a CONSORT EHEALTH database form, were asked to score the importance of CONSORT EHEALTH items, and were asked to provide narrative feedback on the value of the process.

RESULTS

Between August 2011 and November 2012, 67 randomized trials were submitted, of which 61 were intended for publication in JMIR. Authors reported that it took between 1 and 16 hours to complete the checklist including making required changes to their manuscripts. 72% (48/67) of authors reported they made minor changes to the manuscript, 6% (4/67) made major changes. Most authors felt it was a useful process that improved their manuscripts: 63% (42/67) said it improved their manuscript, 13% (9/67) said it did not, 12% (8/67) indicated that it had improved a little.

CONCLUSIONS

The CONSORT EHEALTH statement and checklist appeared successful in improving the quality of reporting. The checklist should be endorsed and used by authors and editors of other journals.