与中医结构化电子病历相结合的e-CRF研制思路与结合方式

当前，国际上日益重视临床试验或临床研究中电子病例报告表（e—CRF）的利用。就中医临床科研信息一体化采集系统（中医结构化电子病历）与中医e—CRF能否相结合，以及二者相结合的必要性、可行性、具体方法和模式、其中的关键环节，以及二者结合的价值、优势和意义等问题进行了思考和探讨。初步认为，结构化电子病历与e—CRF二者的结合是必要和可行的。具有一定优势和重要意义。具体模式可在开发平台、术语和接口三个方面进行。同时，二者结合可能是未来将临床结构化电子病历引入临床观察研究的一种形式；而且，未来二者结合的模式将更适于大规模复杂干预的临床研究，为中医临床研究带来更多实用和便捷，必将拥有广泛的应用前景。

Ideas and Ways in Designing the e-CRF Combined with the TCM Structured Electronic Medical Record and Research on the Combination Mode

At present, the importance attached to electronic case report form （e-CRF） in clinical trials or clinical studies is kept growing in the international world. In this paper, issues on combination of the TCM clinic and research information integration and sharing collection system （TCM-structured electronic medical record） and the Chinese e-CRF are considered and discussed, issues such as whether they can be combined, the necessity, feasibility, specific methods and models, key link in combination, as well as the value, advantages and significance of the combination. The preliminary view is that the combination is necessary and feasible, and has certain advantages and importance. The specific modes have three different ways in platform development, terminology, and interfaces. At the same time, we believe that a combination of both may be a form of introduction of structured electronic medical record to clinical studies in the future; and the combination models will be more suitable for large-scale clinical study of a complex intervention in the future, it will bring Chinese medicine clinical research more practical and convenient, and will have a more extensive application prospects.