Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.
J Am Med Inform Assoc. 2013 May 1;20(3):568-76. doi: 10.1136/amiajnl-2012-001175. Epub 2012 Oct 13.
The internet is increasingly being used to conduct randomized controlled trials (RCTs). Knowledge of the types of interventions evaluated and the methodological quality of these trials could inform decisions about whether to conduct future trials using conventional methods, fully online or a mixture of the two.
To identify and describe the scope of internet-based RCTs for human health condition interventions and evaluate their methodological quality.
A systematic review of RCTs of any health intervention conducted fully or primarily on the internet was carried out.
23 fully and 27 primarily internet-based RCTs were identified. The first was conducted in 2000. The majority of trials evaluated interventions that involved providing health information to participants, but a few evaluated self-administered interventions (eg, valerian, stretching). Methodological quality was variable and the methods were generally poorly reported. The risk of bias was low in only a small number of trials; most had substantial methodological shortcomings. Only one trial was identified as meeting all criteria for adequate methodological quality. A particular problem was high rates of loss to follow-up (fully online: mean 47%; primarily online: mean 36%).
It is theoretically possible but perhaps difficult to test the effectiveness of health interventions rigorously with RCTs conducted fully or primarily over the internet. The use of the internet to conduct trials is more suited to pragmatic rather than explanatory trials. The main limitation of these trials is that they typically experience high rates of loss to follow-up. Methodological standards now accepted for traditional RCTs needs to be evident for online RCTs as well, especially in reporting of their methods.
互联网越来越多地被用于开展随机对照试验（RCT）。了解评估的干预措施类型和这些试验的方法学质量，可以为是否使用传统方法、完全在线或两者混合的方式进行未来试验做出决策。
确定并描述基于互联网的人类健康状况干预措施 RCT 的范围，并评估其方法学质量。
对完全或主要在互联网上进行的任何健康干预 RCT 进行系统评价。
确定了 23 项完全基于互联网和 27 项主要基于互联网的 RCT。第一项试验于 2000 年进行。大多数试验评估了向参与者提供健康信息的干预措施，但也有一些评估了自我管理干预措施（例如缬草根、伸展运动）。方法学质量参差不齐，方法通常报告得很差。只有少数试验的偏倚风险较低；大多数试验都存在严重的方法学缺陷。只有一项试验被确定为符合充分方法学质量的所有标准。一个特别的问题是失访率高（完全在线：平均 47%；主要在线：平均 36%）。
理论上可以，但可能很难通过完全或主要通过互联网进行的 RCT 严格测试健康干预措施的有效性。使用互联网进行试验更适合实用性而不是解释性试验。这些试验的主要限制是它们通常会出现较高的失访率。现在为传统 RCT 接受的方法学标准也需要在线 RCT 中得到体现，尤其是在其方法的报告中。
