Wyatt J
ICRF Centre for Statistics in Medicine, Institute for Health Sciences, Headington, Oxford, UK.
Int J Med Inform. 1997 Dec;47(3):165-73. doi: 10.1016/s1386-5056(97)00100-7.
To ensure the correctness of publicity material ('truth in labelling') and to inform their licensing decisions, agencies certifying or regulating any clinical computer system will need information about the system's structure, performance and likely impact on users and the environment in which they work. This information must be reliable and complete, so it needs to be collected in a structured, rigorous evaluation programme. Clinical decision support systems are generally more complex and their effects less easy to predict than most other clinical software, so pose the greatest challenge to evaluators. They are therefore the focus of this paper.
为确保宣传材料的正确性（“标签内容属实”）并为其许可决策提供依据，对任何临床计算机系统进行认证或监管的机构将需要有关该系统的结构、性能以及对用户及其工作环境可能产生的影响的信息。此信息必须可靠且完整，因此需要通过结构化、严格的评估程序来收集。临床决策支持系统通常比大多数其他临床软件更为复杂，其效果也更难预测，因此对评估人员构成了最大的挑战。所以，它们是本文的重点。
