Hammond P, Sergot M J, Wyatt J C
Brunel University, Uxbridge, UK.
Proc Annu Symp Comput Appl Med Care. 1995:253-7.
Written protocols are often employed to guide patient care. For treatment within a clinical trial, compliance with the trial protocol may be critical in ensuring efficacy and safety. Previous empirical work has established generic safety principles for reasoning about adverse events in clinical trials and their formalisation has been applied in a decision support system for managing treatment plans in oncology. The same generic knowledge can be reused to generate specific safety clauses when designing new treatment plans. Typically, clinicians devise trial protocols relatively infrequently and so software aids, especially those assisting with regulatory/safety conformance, will encourage more effective use of their time. A similar approach to the formalisation of safety knowledge in the control of hazardous industrial processes is discussed.
书面方案通常用于指导患者护理。对于临床试验中的治疗，遵循试验方案对于确保疗效和安全性可能至关重要。先前的实证研究已经确立了关于临床试验中不良事件推理的通用安全原则，并且其形式化已应用于肿瘤学治疗计划管理的决策支持系统中。在设计新的治疗计划时，可以重复使用相同的通用知识来生成特定的安全条款。通常，临床医生制定试验方案的频率相对较低，因此软件辅助工具，尤其是那些有助于符合监管/安全要求的工具，将鼓励更有效地利用他们的时间。本文还讨论了在危险工业过程控制中对安全知识进行形式化的类似方法。
