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

描述(由申请人提供)： 这项拟议的研究将开发和评估“住院患者监测不良事件(时间)的工具，以进行安全和适当的测试。”我们的研究假设是： (H1)治疗-实验室结果数据库将能够确定各种疗法的不良反应的时间进程、严重程度和共同决定因素(由临床实验室结果衡量)(即，该数据库可以为记录治疗-实验室效果配对提供循证机制)。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)了解H1与治疗相关的不良事件的准确时间和决定因素将使我们能够改变最终用户的订购行为，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到不良事件。我们将使用基于CPOE的干预措施具体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，其中包括住院患者的常见治疗干预命令和常见实验室结果报告。 目的2：使用样本病历审计验证数据库的代表性(1)确保存储在数据库中的治疗顺序是所实施治疗的合理替代，以及(2)验证目标实验室异常可靠地反映了给予感兴趣药物的患者的药物不良反应而不是其他异常。 目的3：展示数据库的实用性，以确定不良反应的发生率、严重性、时间进程和副反应的协变量决定因素，至少11个指定的众所周知的、通常监测的治疗-不良实验室结果对中的6个。 目的4：进行数据挖掘以发现新的治疗毒性和AIM 3毒性的共同决定因素。 目的5：展示数据库对调查治疗-实验室效果配对的一般效用，对于目标3的6个治疗实验室配对，通过当地的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，(B)防止测试过于频繁而无法检测到不良事件。这将包括详细分析至少一种此类干预措施的经济影响，并构建一个用于分析未来潜在干预措施的“通用模型”。 目的6：出版/为合格的研究人员提供对治疗实验室数据库匿名版本的访问，作为进一步研究不良反应监测策略的一般研究工具。

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.