提高中医电子CRF功能需求的研究与实践

针对提高中医e—CRF功能的两类特殊需求，即：设计与中医结构化电子病历相结合的e—CRF，使二者实现数据共享；对e—CRF模版进行一定的功能设计，包括操作中的便捷和智能功能设计，进行了研制新思路的探讨，并对实践结果加以总结。初步认为。这二个需求的满足对提高e—CRF使用的便捷性和顺应性具有重要意义；同时，实现二者数据共享。对于提高中医复杂干预和临床复杂评价方式介入的临床研究的便捷性具有重要价值。利用采集系统开发平台开发e—CRF，是解决这一问题的有效途径。具体实践中。还需对其中的操作细节给予关注和改善，以便扩大CRF的灵活性和可调性，达到实用性和数据共享的效果。

New Ideas and New Practices for Improving the Functional Requirements During Study and Manufacture of Traditional Chinese Medicine(TCM)Electronic Clinical Report Forms(e-CRF)

In this paper, new study and manufacture ideas are discussed aiming to meet the two types of special needs or requirements in increasing TCM e-CRF functions, and the related new practices results are reported. These two requirements are： the combination design of TCM structured electronic medical record with the TCM e-CRF, so that data sharing between them can be realized; a certain degree of functional designs in the e-CRF data collection template, including the convenience operation designs and smart features designs. In a preliminary view, both requirements may be of great importance in improving convenience and compliance in e-CRF use, especially the former is of great value in both realization of data sharing between them and improving convenience in clinical studies with traditional Chinese medicine complex interventions and complicated clinical evaluation. Using the collection system development platform to explore the e-CRFs is an effective way to solve these problems. Moreover, in concrete practice, operational details should be emphasised and improved, so that the flexibility and adjustability of e-CRFs can be expanded and satisfactory effects of their availability and data sharing may be achieved.