Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.
Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.
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DOI：
10.1002/pds.4295
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发表时间：
2017-09
影响因子：
2.6
通讯作者：
joint ISPE-ISPOR Special Task Force on Real World Evidence in Health Care Decision Making
中科院分区：
文献类型：
--
作者：
Wang SV;Schneeweiss S;Berger ML;Brown J;de Vries F;Douglas I;Gagne JJ;Gini R;Klungel O;Mullins CD;Nguyen MD;Rassen JA;Smeeth L;Sturkenboom M;joint ISPE-ISPOR Special Task Force on Real World Evidence in Health Care Decision Making
定义研究人群并从纵向医疗保健数据库创建分析数据集涉及许多决策。我们的目标是将支持研究执行的科学决策编目，这些决策应该被报告，以促进复制并能够评估在大型医疗保健数据库中进行的研究的有效性。我们回顾了运行宏和软件工具样本所需的关键研究人员决策，这些工具旨在从医疗保健数据的纵向流中创建和分析分析队列。一个由医疗保健数据库分析方面的学术、监管和行业专家组成的小组进行了讨论，并将其添加到此列表中。决策者越来越多地寻求从大型医疗保健遭遇和报销数据库中产生的证据。世界各地对相同的概念使用了不同的术语。商定术语以及大型目录中哪些参数是报告可复制研究的最重要参数将提高透明度并促进有效性评估。至少，在创建分析数据集时，数据库研究报告应提供关键时间锚的操作定义及其相互关系的清晰度，并附有消耗表和设计图。通过提高用于从纵向医疗数据库创建分析数据集的操作研究参数的透明度，可以在从医疗保健数据库生成的真实世界证据的重复性、精确性和置信度方面实现实质性改进。
Defining a study population and creating an analytic dataset from longitudinal healthcare databases involves many decisions. Our objective was to catalogue scientific decisions underpinning study execution that should be reported to facilitate replication and enable assessment of validity of studies conducted in large healthcare databases. We reviewed key investigator decisions required to operate a sample of macros and software tools designed to create and analyze analytic cohorts from longitudinal streams of healthcare data. A panel of academic, regulatory, and industry experts in healthcare database analytics discussed and added to this list. Evidence generated from large healthcare encounter and reimbursement databases is increasingly being sought by decision‐makers. Varied terminology is used around the world for the same concepts. Agreeing on terminology and which parameters from a large catalogue are the most essential to report for replicable research would improve transparency and facilitate assessment of validity. At a minimum, reporting for a database study should provide clarity regarding operational definitions for key temporal anchors and their relation to each other when creating the analytic dataset, accompanied by an attrition table and a design diagram. A substantial improvement in reproducibility, rigor and confidence in real world evidence generated from healthcare databases could be achieved with greater transparency about operational study parameters used to create analytic datasets from longitudinal healthcare databases.
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影响因子：
3
作者：
Brookhart MA;Stürmer T;Glynn RJ;Rassen J;Schneeweiss S
通讯作者：
Schneeweiss S
影响因子：
2.6
作者：
Berger, Marc L.;Sox, Harold;Daniel Mullins, C.
通讯作者：
Daniel Mullins, C.
影响因子：
64.8
作者：
Collins, Francis S.;Tabak, Lawrence A.
通讯作者：
Tabak, Lawrence A.
影响因子：
3.4
作者：
Engel, Pierre;Almas, Mariana Ferreira;Dreyer, Nancy Ann
通讯作者：
Dreyer, Nancy Ann
影响因子：
15.8
作者：
Bouwmeester W;Zuithoff NP;Mallett S;Geerlings MI;Vergouwe Y;Steyerberg EW;Altman DG;Moons KG
通讯作者：
Moons KG