TIME:(Tools for Inpatient Monitoring using Evidence)for Safe & AppropriateTesting

TIME：（使用证据进行住院患者监测的工具）确保安全

• 批准号: 7012300
• 负责人: RANDOLPH A MILLER
• 金额: $ 33.18万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-02-01 至 2007-06-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7012300
• 关键词: clinical research; computer assisted medical decision making; computer assisted patient care; computer system design /evaluation; diagnosis quality /standard; drug adverse effect; health care facility information system; health economics; human data; information system analysis; patient care management; patient safety /medical error; therapy adverse effect

DESCRIPTION (provided by applicant): The proposed study will develop and evaluate "Tools for Inpatient Monitoring of adverse Events (TIME) for safe and appropriate testing." Our research hypotheses are: (H1) A therapy-lab result DB will enable determination of the time course, severity, and co-determinants of adverse effects (as measured by clinical laboratory results) of various therapies (i.e., the database can provide an evidence-based mechanism for documenting therapy-lab effect pairings). We will test this using six commonly recognized and frequently monitored therapy-effect pairs. (H2) Knowledge of the precise timing and determinants of therapy-related adverse events from H1 will enable us to alter end-user ordering behaviors in a manner to (a) decrease unnecessary testing and (b) prevent testing too infrequently to detect adverse events. We will specifically study the six therapy-lab pairs of the first hypothesis using CPOE-based interventions. The "TIME for safe and appropriate testing" project will accomplish the following objectives: Aim 1: Construct a secure and confidential reference database, covering August 1999- July 2003 inclusive, of orders for common therapeutic interventions and reports of common laboratory results for inpatients. Aim 2: Validate the representativeness of the database using sample patient chart audits (1) to ensure that the therapy orders stored in the database are a reasonable proxy for therapies administered, and (2) to verify that the targeted lab abnormalities reliably reflect adverse drug effects rather than other abnormalities in patients given the drugs of interest. Aim 3: Demonstrate database utility to define incidence, severity, time course, and covariate determinants of adverse effects for at least 6 out of 11 specified well known, commonly monitored therapy-adverse laboratory result pairs. Aim 4: Perform data mining to discover novel therapeutic toxicities and co-determinants of Aim 3 toxicities. Aim 5: Demonstrate the generic utility of the database for investigating therapy-lab effect pairings, for six of the therapy lab pairs of Aim 3, implement decision support tools via the local CPOE system to (a) decrease unnecessary adverse effect monitoring tests and (b) prevent testing too infrequently to detect adverse events. This will include detailed analysis of the economic impact of at least one such intervention, and construction of a "generic model" for analysis of potential future interventions. Aim 6: Publish/provide access for qualified researchers to an anonymous version of the therapy-lab database as a general research tool to further study adverse effect monitoring strategies.

描述（由申请人提供）： 拟议研究将开发和评价“住院患者不良事件监测工具（TIME），以进行安全和适当的测试。“我们的研究假设是： (H1)治疗-实验室结果DB将能够确定各种治疗（即，数据库可以提供用于记录治疗-实验室效应配对的基于证据的机制）。我们将使用六个公认的和经常监测的治疗效果对来测试这一点。 (H2)从H1中了解治疗相关不良事件的确切时间和决定因素将使我们能够改变最终用户订购行为，以（a）减少不必要的测试和（B）防止测试过于频繁而无法检测不良事件。 我们将使用基于CPOE的干预措施，专门研究第一个假设的六个治疗实验室对。“安全和适当测试的时间”项目将实现以下目标： 目标1：建立一个安全和保密的参考数据库，涵盖1999年8月至2003年7月，包括住院病人的常用治疗干预措施订单和常用实验室结果报告。 目标二：使用样本患者病历审核验证数据库的代表性，以（1）确保数据库中存储的治疗订单是所给予治疗的合理替代，以及（2）验证目标实验室异常可靠地反映了药物不良反应，而不是给予目标药物的患者的其他异常。 目标三：证明数据库可用于定义11个指定的已知、通常监测的治疗-不良实验室结果对中至少6个的不良反应的发生率、严重程度、时间进程和协变量决定因素。 目的4：进行数据挖掘，以发现新的治疗毒性和目的3毒性的共同决定因素。 目标5：证明数据库用于研究治疗-实验室效应配对的通用效用，对于目标3的6个治疗实验室配对，通过当地CPOE系统实施决策支持工具，以（a）减少不必要的不良反应监测测试和（B）防止测试过于频繁而无法检测不良事件。这将包括详细分析至少一项此类干预措施的经济影响，并构建一个“通用模型”，用于分析未来可能的干预措施。 目标六：发布/为合格的研究人员提供访问治疗实验室数据库的匿名版本，作为进一步研究不良反应监测策略的一般研究工具。