Defining the Learning Curve in Research Trials

定义研究试验中的学习曲线

• 批准号: 6945797
• 负责人: JEFFREY M TAEKMAN
• 金额: $ 16万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6945797
• 关键词: clinical research; clinical trials; computer simulation; data collection methodology /evaluation; data quality /integrity; human data; patient safety /medical error

DESCRIPTION (provided by applicant): Clinical trials play an important role in the advancement of medical care. Over $ 6 billion are spent annually on clinical research. Clinical protocols are increasingly complex. Data inaccuracy in the early phase of a new research trial is a commonly known, but incompletely described component of clinical research. These errors are likely a result of coordinators lacking mastery of the knowledge, skills, and attitudes needed to properly conduct the research protocol. Most historical studies on research integrity consider ethical issues associated with clinical trials and protocol design. Little attention has been paid to issues of data integrity and patient safety in the proper conduct of a trial. Modern theory stresses the importance of interactivity in learning. Simulation is considered a top methodology for learning complex behaviors. The use of high-fidelity patient simulation in clinical research training is expected to improve the coordinator's acquisition of the knowledge, skills, and behaviors needed to properly perform a protocol. Enhanced coordinator performance is expected to lead to improved data integrity and heightened patient safety. Recent efforts in our laboratory demonstrate marked improvement in coordinator confidence following high-fidelity simulation training (in their ability to properly conduct the trial). Objective measures of coordinator competence are now needed to properly assess the effects of simulation training on research integrity. One objective method of assessing coordinator competence is through queries of errors in the protocol's data record. The goal of this study is to first define a taxonomy to categorize and quantify clinical research errors rates in a reproducible fashion. We will then apply our taxonomy to define baseline error rates and the learning curve in a recently completed NIH funded multi-center trial. This proposal is intended to provide the groundwork for later studies investigating the impact of high-fidelity simulation on the competent performance of clinical trials.

描述（由申请人提供）： 临床试验在医疗保健的进步中发挥着重要作用。每年用于临床研究的费用超过60亿美元。临床方案越来越复杂。新研究试验早期阶段的数据不准确是临床研究中一个众所周知但描述不完整的组成部分。这些错误可能是协调员缺乏正确执行研究方案所需的知识、技能和态度的结果。大多数关于研究诚信的历史研究都考虑了与临床试验和方案设计相关的伦理问题。很少有人注意到数据完整性和患者安全性问题，在适当的试验进行。现代理论强调了互动在学习中的重要性。模拟被认为是学习复杂行为的顶级方法。在临床研究培训中使用高保真患者模拟有望提高协调员对正确执行方案所需的知识、技能和行为的掌握。增强协调员的性能，预计将导致改善数据的完整性和提高病人的安全。我们实验室最近的努力表明，在高保真模拟训练（正确进行试验的能力）后，协调员的信心有了显著提高。现在需要协调员能力的客观措施，以正确评估模拟训练对研究完整性的影响。评估协调员能力的一种客观方法是通过查询协议数据记录中的错误。本研究的目标是首先定义一个分类法，以可重复的方式对临床研究错误率进行分类和量化。然后，我们将在最近完成的NIH资助的多中心试验中应用我们的分类法来定义基线错误率和学习曲线。该建议旨在为后续研究提供基础，研究高保真模拟对临床试验性能的影响。

项目成果

Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve.

• DOI: 10.1136/qshc.2008.028605
• 发表时间: 2010-10
• 期刊: Quality & safety in health care
• 作者: Taekman JM;Stafford-Smith M;Velazquez EJ;Wright MC;Phillips-Bute BG;Pfeffer MA;Sellers MA;Pieper KS;Newman MF;Van de Werf F;Diaz R;Leimberger J;Califf RM
• 通讯作者: Califf RM