Electronic Clinical Records for Medical Research

医学研究电子临床记录

• 批准号: 6899348
• 负责人: RICHARD L TANNEN
• 金额: $ 59.9万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-15 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6899348
• 关键词: automated medical record system; behavioral /social science research tag; cardiovascular disorder; clinical research; clinical trials; computer assisted medical decision making; data management; drug screening /evaluation; health care policy; health care professional practice; health care service evaluation; health science research analysis /evaluation; human data; human therapy evaluation; meta analysis; outcomes research; outpatient care; patient care planning; statistics /biometry

DESCRIPTION (provided by applicant): The implementation of clinical practice electronic records will provide access to comprehensive data of outcomes in response to clinical interventions for large populations. Analyzed appropriately, this information compiled into databases will have enormous potential to assess treatment effectiveness, both expanding and complementing the results of Randomized Controlled Trials (RCTs). However, because of pitfalls with observational Studies and validity of data from clinical records, proof of principle is needed prior to capitalizing appropriately on the enormous potential of this data. Our long-term goal is to determine whether and how non-experimental data from an electronic Ambulatory Medical Record Database can be used to reliably inform the practice of medicine. This application will examine the validity of Observational Studies using data from the UK General Practice Research Database (GPRD) to assess treatment effectiveness based on rigorous comparisons with published RCTs of cardiovascular disease. Each GPRD Study will use a modeled prospective cohort design that, to the extent possible, will reconstruct the RCT with the exception of randomization, by employing similar inclusion/exclusion criteria, treatment protocol and outcome measures. Outcomes will be analyzed by adjustment for measured confounders using propensity scores and/or multivariable regression. We also will test whether specific study characteristics predict the likelihood for obtaining a valid result with a GPRD Study. Therefore the aggregated results from 20 RCTGPRD comparative studies will be examined for predictors of concordance. If individual GPRD Studies are concordant, they will be repeated using broader entry criteria in order to examine their utility to expand generalizability. The expanded GPRD study will be compared with the initial restricted Study and with meta-analyses relevant to the comparable RCT to examine their usefulness for this purpose. Thus the Specific Aims of this study will be to assess: 1. Concordance between outcomes to therapy when GPRD Studies are subjected to rigorous comparison with comparable published RCTs of cardiovascular disease, 2. Whether particular characteristics predict concordance (or lack thereof) between results of RCTs and GPRD Studies 3. Whether GPRD Studies can verify as well as expand the generalizability of findings from RCTs.

描述（由申请人提供）：临床实践电子记录的实施将提供针对大量人群的临床干预结果的综合结果数据。经过适当的分析，这些被编入数据库的信息将具有评估治疗效果的巨大潜力，既扩展又补充了随机对照试验（RCT）的结果。然而，由于观察性研究的缺陷和临床记录数据的有效性，在适当利用这些数据的巨大潜力之前需要进行原理证明。我们的长期目标是确定是否以及如何使用电子流动病历数据库中的非实验数据来可靠地为医学实践提供信息。 该应用程序将使用英国全科医学研究数据库 (GPRD) 的数据来检查观察性研究的有效性，以根据与已发表的心血管疾病随机对照试验的严格比较来评估治疗效果。每项 GPRD 研究将使用建模的前瞻性队列设计，通过采用类似的纳入/排除标准、治疗方案和结果测量，尽可能重建随机对照试验（随机化除外）。将使用倾向评分和/或多变量回归通过调整测量的混杂因素来分析结果。我们还将测试特定的研究特征是否可以预测通过 GPRD 研究获得有效结果的可能性。因此，将对 20 项 RCTGRD 比较研究的汇总结果进行一致性预测。如果个别 GPRD 研究是一致的，将使用更广泛的进入标准重复它们，以检查其实用性以扩大普遍性。扩展的 GPRD 研究将与最初的限制性研究以及与可比 RCT 相关的荟萃分析进行比较，以检查其为此目的的有用性。因此，本研究的具体目标将是评估： 1. 当 GPRD 研究与已发表的心血管疾病随机对照试验进行严格比较时，治疗结果之间的一致性， 2. 特定特征是否预测结果之间的一致性（或缺乏一致性） RCT 和 GPRD 研究 3. GPRD 研究是否可以验证并扩大 RCT 结果的普遍性。