The University of Dundee Centre for Primary Care and Population Research, Health Informatics Centre, Scottish Dental Clinical Effectiveness Programme, Dental Health Services & Research Unit, Dundee, UK.
J Am Med Inform Assoc. 2011 Mar-Apr;18(2):173-80. doi: 10.1136/jamia.2010.010306. Epub 2011 Jan 26.
There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit.
在医学信息学界，有一小部分人一直认为随机对照试验（RCT）在评估临床信息系统方面的作用有限。怀疑论者普遍认为，这些系统与药物干预有根本的不同，因此 RCT 是不相关的。鉴于向基于证据的政策转变以及需要证明这些系统的成本效益，迫切需要促进 RCT 的使用。作者建议回归基本原则，并认为需要明确如何将方法与评估问题相匹配。作者解决了关于 RCT 的常见问题，以及它们在多大程度上是错误的，还讨论了在信息学中进行 RCT 以及在随机试验不可行时替代研究设计的挑战。虽然 RCT 不是一种完美或普遍的评估方法，但它是评估者工具包的重要组成部分。
