Eysenbach Gunther
Centre for Global eHealth Innovation & Techna Institute, University Health Network, Toronto, Canada.
Stud Health Technol Inform. 2013;192:657-61.
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.
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.
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.
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.
基于网络和移动设备的干预措施的随机试验带来了非常特殊的问题和挑战。2011年8月以草案形式、2011年12月以期刊文章形式（V1.6.1）发表的《CONSORT-EHEALTH声明》（电子和移动健康应用及在线远程医疗试验报告统一标准）最近总结了一套关于如何开展和报告此类试验的最佳实践。本报告的目的是回顾在领先的电子健康期刊《医学互联网研究杂志》（JMIR）进行的试点实施结果，2011年末在该杂志按照CONSORT-EHEALTH报告试验成为强制性要求。
要求所有提交给JMIR的随机试验的作者完成一份电子问卷，其中包括将相关的稿件部分复制到CONSORT EHEALTH数据库表格中，要求对CONSORT EHEALTH项目的重要性进行评分，并要求提供关于该过程价值的叙述性反馈。
在2011年8月至2012年11月期间，提交了67项随机试验，其中61项打算在JMIR上发表。作者报告说，完成清单（包括对手稿进行必要修改）花费的时间在1至16小时之间。72%（48/67）的作者报告他们对手稿进行了小的修改，6%（4/67）进行了重大修改。大多数作者认为这是一个有用的过程，改进了他们的稿件：63%（42/67）的人说这改进了他们的稿件，13%（9/67）的人说没有，12%（8/67）表示有一点改进。
CONSORT EHEALTH声明和清单似乎成功地提高了报告质量。该清单应得到其他期刊的作者和编辑的认可并使用。
