caCDE-QA: A Quality Assurance Platform for Cancer Study Common Data Elements

caCDE-QA：癌症研究通用数据元素的质量保证平台

• 批准号: 8913908
• 负责人: Guoqian Jiang
• 金额: $ 41.24万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8913908
• 关键词: Address; Adopted; Algorithms; Clinical; Clinical Data; Clinical Research; Collaborations; Common Data Element; Communities; Community Services; Data; Data Element; Data Quality; Data Storage and Retrieval; Detection; Dictionary; Face; Fostering; Goals; Health; Internet; Life Cycle Stages; Malignant Neoplasms; Metadata; Methods; Modeling; National Cancer Institute; Network-based; Online Systems; Outcome; Performance; Publishing; Research; Semantics; Services; Standardization; Structure; Technology; Testing; The Cancer Genome Atlas; Unified Medical Language System; Validation; base; computer based Semantic Analysis; cost; data sharing; design; information model; novel; quality assurance; repository; research study; tool; usability; Address; Adopted; Algorithms; Clinical; Clinical Data; Clinical Research; Collaborations; Common Data Element; Communities; Community Services; Data; Data Element; Data Quality; Data Storage and Retrieval; Detection; Dictionary; Face; Fostering; Goals; Health; Internet; Life Cycle Stages; Malignant Neoplasms; Metadata; Methods; Modeling; National Cancer Institute; Network-based; Online Systems; Outcome; Performance; Publishing; Research; Semantics; Services; Standardization; Structure; Technology; Testing; The Cancer Genome Atlas; Unified Medical Language System; Validation; base; computer based Semantic Analysis; cost; data sharing; design; information model; novel; quality assurance; repository; research study; tool; usability

DESCRIPTION (provided by applicant): Domain-specific common data elements (CDEs) are emerging as an effective approach to standards-based clinical research data storage and retrieval and have been broadly adopted. For example, the National Cancer Institute (NCI) created the Cancer Data Standards Repository (caDSR) based on the ISO/IEC 11179 standard for metadata repositories. However, cancer clinical research community faces significant challenges related to scalability, governance, and data quality for CDE modeling. In particular, the lack of robust, principled and automated QA algorithms contributes to CDE content errors that can have a significant negative impact on downstream CDE uses. Our overall goal is to build a novel quality assurance (QA) framework to overcome methodological and computational challenges with respect to error detection in the modeling of common data elements (CDEs), recognition of duplicates or similar CDEs, and CDE usability, thereby producing high-quality CDEs for cancer clinical research studies. Our proposed approach is to design, develop and evaluate an integrative platform known as caCDE-QA that implements a suite of QA tools to audit experimental cancer study CDEs represented in a semantic web framework, deploying a QA web-portal with standard semantic services for community collaboration. Our specific aims are: (1) To develop a suite of QA tools for validation and harmonization of cancer study CDEs. (2) To apply the QA tools to audit experimental cancer study CDEs represented in a semantic web framework. We will also evaluate the performance of the QA tools in terms of efficiency, accuracy and usability by comparing with the baseline tools that exist in the NCI caDSR and CIMI communities. (3) To deploy and evaluate a QA web-portal for collaborative CDE review and harmonization. We will coordinate community-based efforts soliciting requirements regarding cancer study CDE discovery and harmonization and fostering a specification of the common data element services (CDES) standard. We will disseminate and test the newly developed QA methods and tools in collaboration with the Clinical Data Interchange Standards Consortium (CDISC) and CIMI Communities. This project will contribute novel QA methods and tools for validation and semantic harmonization of cancer study CDEs. This is of great significance in that it will be enabling efficient CDE modeling and producing high-quality reusable CDEs, which are critical for facilitating cancer clinical research data sharing and accelerating systematic clinical outcomes capturing.

描述（由申请人提供）：特定领域的共同数据元素（CD）已成为一种有效的基于标准的方法来解决基于标准的临床研究数据存储和检索，并且已广泛采用。例如，国家癌症研究所（NCI）基于ISO/IEC 11179元数据存储库标准创建了癌症数据标准库（CADSR）。但是，癌症临床研究社区面临着与CDE建模的可伸缩性，治理和数据质量有关的重大挑战。特别是，缺乏健壮，原则和自动化的QA算法会导致CDE含量误差，这可能会对下游CDE的使用产生重大的负面影响。我们的总体目标是建立一个新颖的质量保证（QA）框架，以克服通用数据元素（CDE）的误差检测（CDES），识别重复或类似CDE的方法论和计算挑战，并为CDE可用性以及CDE可用性，从而为癌症临床研究产生高质量的CDE。我们提出的方法是设计，开发和评估一个名为CACDE-QA的集成平台，该平台实现了一套QA工具来审核在语义Web框架中代表的实验癌症研究CDE，该CDES在语义网络框架中代表，部署了QA Web-portal，其中包含用于社区协作的标准语义服务。我们的具体目的是：（1）开发一套QA工具，用于验证和协调癌症研究CDES。 （2）将质量检查工具应用于语义网络框架中代表的实验癌症研究CDE。我们还将通过与NCI CADSR和CIMI社区中存在的基线工具进行比较，从效率，准确性和可用性方面评估质量检查工具的性能。 （3）部署和评估质量检查网站，以进行协作CDE审核和协调。我们将协调基于社区的努力征求有关癌症研究的要求CDE发现和协调并培养公共数据元素服务（CDES）标准的规范。我们将通过与临床数据交换标准联盟（CDISC）和CIMI社区合作进行传播和测试新开发的质量检查方法和工具。该项目将为验证和语义统一的癌症研究CDE的新型质量检查方法和工具提供贡献。这具有重要意义，因为它将实现有效的CDE建模并产生高质量的可重复使用CDE，这对于促进癌症临床研究数据共享和加速系统临床结果至关重要。