A systematic review of cardiac in-silico clinical trials.
A systematic review of cardiac in-silico clinical trials.
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DOI：
10.1088/2516-1091/acdc71
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发表时间：
2023-07-01
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
心脏的计算模型现在被用于通过计算机模拟临床试验（ISCT）评估干预措施的有效性和可行性。随着越来越多的国家采用和接受信息系统支助小组，将出现报告方法和分析结果的最佳做法。我们以心脏病学领域为重点，旨在评估ISCT的类型、分析方法和报告标准。为此，我们按照系统综述和荟萃分析（PRISMA）的首选报告项目，对2012年1月1日至2022年1月1日期间的心脏ISCT进行了系统综述。我们考虑了人类患者队列的心脏ISCT，并排除了单个个体的研究和那些使用模型指导手术而不与对照组进行比较的研究。我们确定了36篇描述心脏ISCT的出版物，其中大部分研究来自美国和英国。在这些研究中，进行了验证步骤，尽管不同研究之间的具体验证类型不同。ANSYS FLUENT是ISCT中最常用的软件。研究中未报告使用的特定软件。与临床试验不同，我们发现缺乏对患者人口统计学的一致性报告，其中的研究没有报告。不确定性量化有限，仅在研究中进行了敏感性分析。在这些ISCT中，没有提供链接以方便访问研究中使用的数据或模型。对于可能被视为ISCT的广泛研究，研究类型的命名不一致。显然，社区需要就患者人口统计学的最低报告标准、ISCT队列质量控制的公认标准、不确定性量化以及增加模型和数据共享达成一致。
Computational models of the heart are now being used to assess the effectiveness and feasibility of interventions through in-silico clinical trials (ISCTs). As the adoption and acceptance of ISCTs increases, best practices for reporting the methodology and analysing the results will emerge. Focusing in the area of cardiology, we aim to evaluate the types of ISCTs, their analysis methods and their reporting standards. To this end, we conducted a systematic review of cardiac ISCTs over the period of 1 January 2012–1 January 2022, following the preferred reporting items for systematic reviews and meta-analysis (PRISMA). We considered cardiac ISCTs of human patient cohorts, and excluded studies of single individuals and those in which models were used to guide a procedure without comparing against a control group. We identified 36 publications that described cardiac ISCTs, with most of the studies coming from the US and the UK. In of the studies, a validation step was performed, although the specific type of validation varied between the studies. ANSYS FLUENT was the most commonly used software in of ISCTs. The specific software used was not reported in of the studies. Unlike clinical trials, we found a lack of consistent reporting of patient demographics, with of the studies not reporting them. Uncertainty quantification was limited, with sensitivity analysis performed in only of the studies. In of the ISCTs, no link was provided to provide easy access to the data or models used in the study. There was no consistent naming of study types with a wide range of studies that could potentially be considered ISCTs. There is a clear need for community agreement on minimal reporting standards on patient demographics, accepted standards for ISCT cohort quality control, uncertainty quantification, and increased model and data sharing.
影响因子：
7.7
作者：
Rodero C;Strocchi M;Lee AWC;Rinaldi CA;Vigmond EJ;Plank G;Lamata P;Niederer SA
通讯作者：
Niederer SA
影响因子：
3.4
作者：
Zheng B;Duffy D;Tricoci P;Kastrissios H;Pfister M;Wright SD;Gille A;Tortorici MA
通讯作者：
Tortorici MA