Rubin D L, Gennari J, Musen M A
Center for Health Care Evaluation, VA Palo Alto Health Care System, Palo Alto, CA, USA.
Proc AMIA Symp. 2000:724-8.
The increasing complexities of clinical trials have led to increasing costs for investigators and organizations that author and administer those trials. The process of authoring a clinical trial protocol, the document that specifies the details of the study, is usually a manual task, and thus authors may introduce subtle errors in medical and procedural content. We have created a protocol inspection and critiquing tool (PICASSO) that evaluates the procedural aspects of a clinical trial protocol. To implement this tool, we developed a knowledge base for clinical trials that contains knowledge of the medical domain (diseases, drugs, lab tests, etc.) and of specific requirements for clinical trial protocols (eligibility criteria, patient treatments, and monitoring activities). We also developed a set of constraints, expressed in a formal language, that describe appropriate practices for authoring clinical trials. If a clinical trial designed with PICASSO violates any of these constraints, PICASSO generates a message to the user and a list of inconsistencies for each violated constraint. To test our methodology, we encoded portions of a hypothetical protocol and implemented designs consistent and inconsistent with known clinical trial practice. Our hope is that this methodology will be useful for standardizing new protocols and improving their quality.
临床试验日益复杂，导致开展和管理这些试验的研究人员及机构成本不断增加。撰写临床试验方案（即规定研究细节的文件）的过程通常是一项手工任务，因此作者可能会在医学和程序内容中引入细微错误。我们创建了一个方案检查与评估工具（PICASSO），用于评估临床试验方案的程序方面。为实现此工具，我们开发了一个临床试验知识库，其中包含医学领域知识（疾病、药物、实验室检查等）以及临床试验方案的特定要求（入选标准、患者治疗和监测活动）。我们还开发了一组用形式语言表达的约束条件，用于描述撰写临床试验的适当做法。如果使用PICASSO设计的临床试验违反了任何这些约束条件，PICASSO会向用户生成一条消息，并列出每个违反约束条件的不一致之处。为测试我们的方法，我们对一个假设方案的部分内容进行了编码，并实施了与已知临床试验实践一致和不一致的设计。我们希望这种方法将有助于规范新方案并提高其质量。
