The Back Pain Consortium (BACPAC) Research Program Data Harmonization: Rationale for Data Elements and Standards.
The Back Pain Consortium (BACPAC) Research Program Data Harmonization: Rationale for Data Elements and Standards.
复制标题
背痛联盟 (BACPAC) 研究计划数据协调：数据元素和标准的基本原理。
DOI：
10.1093/pm/pnad008
复制
发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Wasserma
中科院分区：
文献类型：
--
作者：
Batorsky,Anna;Bowden,AntonE;Darwin,Jessa;Fields,AaronJ;Greco,CarolM;Harris,RichardE;Hue,TrishaF;Kakyomya,Joseph;Mehling,Wolf;O'Neill,Conor;Patterson,CharityG;Piva,SaraR;Sollmann,Nico;Toups,Vincent;Wasan,AjayD;Wasserma
背部疼痛联盟（BACPAC）研究计划的一个目标是开发一个由转化研究和临床试验的综合数据提供信息的慢性腰痛综合模型。我们描述的努力，以最大限度地提高数据的协调和可访问性，以促进Consortium-wide analysis.MethodsConsortium-wide工作组建立了统一的数据元素，收集在所有的研究和制定标准的表格和非表格数据（如，成像和组学）。开发的BACPAC数据门户网站，以促进整个Consortium.ResultsClinical专家开发的BACPAC最小数据集所需的域和结果的措施，通过使用问卷调查收集跨项目。其他不需要的特定领域的措施是由多项研究收集。为了优化交叉研究分析，在临床数据交换标准联盟研究数据制表模型的基础上开发了修改后的数据标准，以协调数据结构并促进基线特征、参与者报告的结局、慢性腰痛治疗、临床检查、功能表现、心理社会特征、定量感觉测试、成像和生物力学数据的整合。采用了适应慢性腰痛数据独特特征的标准。研究单位提交标准化的研究数据的BACPAC数据门户，开发作为一个安全的基于云的中央数据存储库和计算基础设施的研究人员访问和进行分析的数据收集或收购的BACPAC.ConclusionsBACPAC协调工作和数据标准作为一个创新的模式，数据集成，可用于其他财团的框架与多个，分散的研究计划。
ObjectiveOne aim of the Back Pain Consortium (BACPAC) Research Program is to develop an integrated model of chronic low back pain that is informed by combined data from translational research and clinical trials. We describe efforts to maximize data harmonization and accessibility to facilitate Consortium-wide analyses.MethodsConsortium-wide working groups established harmonized data elements to be collected in all studies and developed standards for tabular and nontabular data (eg, imaging and omics). The BACPAC Data Portal was developed to facilitate research collaboration across the Consortium.ResultsClinical experts developed the BACPAC Minimum Dataset with required domains and outcome measures to be collected by use of questionnaires across projects. Other nonrequired domain-specific measures are collected by multiple studies. To optimize cross-study analyses, a modified data standard was developed on the basis of the Clinical Data Interchange Standards Consortium Study Data Tabulation Model to harmonize data structures and facilitate integration of baseline characteristics, participant-reported outcomes, chronic low back pain treatments, clinical exam, functional performance, psychosocial characteristics, quantitative sensory testing, imaging, and biomechanical data. Standards to accommodate the unique features of chronic low back pain data were adopted. Research units submit standardized study data to the BACPAC Data Portal, developed as a secure cloud-based central data repository and computing infrastructure for researchers to access and conduct analyses on data collected by or acquired for BACPAC.ConclusionsBACPAC harmonization efforts and data standards serve as an innovative model for data integration that could be used as a framework for other consortia with multiple, decentralized research programs.