The validity of synthetic clinical data: a validation study of a leading synthetic data generator (Synthea) using clinical quality measures
The validity of synthetic clinical data: a validation study of a leading synthetic data generator (Synthea) using clinical quality measures
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DOI：
10.1186/s12911-019-0793-0
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发表时间：
2019-03-14
影响因子：
3.5
通讯作者：
James, Jesse
中科院分区：
文献类型：
--
作者：
Chen, Junqiao;Chun, David;James, Jesse
临床数据合成旨在为医疗研究、系统实施和培训生成真实的数据。它保护患者的机密性，加深了我们对医疗保健复杂性的理解，并且对于难以获得或不需要真实的世界数据的情况，它是一种有前途的工具。然而，它的有效性尚未得到充分研究，以前的研究也没有从医疗质量的角度验证它，这是医疗系统的一个关键方面。本研究通过使用合成数据计算临床质量指标填补了这一空白。我们研究了一个开源的有据可查的合成数据生成器Synthea，该生成器由这一新兴技术的关键进步组成。我们选择了由Synthea生成的具有代表性的120万马萨诸塞州患者队列。根据临床意义选择了四项质量指标，即结直肠癌筛查、慢性阻塞性肺疾病（COPD）30天死亡率、髋关节/膝关节置换术后并发症发生率和控制高血压。然后将计算出的发病率与基于马萨诸塞州和美国真实数据的公开报告的发病率进行比较。在合成马萨诸塞州总人口中（n = 1，193，439），394，476人符合“结直肠癌筛查”质量指标，248，433人（63%）被认为是依从性的，相比之下，公开报道的马萨诸塞州和全国失业率分别为77.3%和69.8%。在409例合格患者中，0.7%的患者在COPD加重后30天内死亡，而马萨诸塞州报告的死亡率为7%，全国为8%。使用扩展逻辑，这一比率增加到5.7%。没有Synthea居民在髋关节/膝关节置换术后出现并发症（马萨诸塞州：2.9%，全国：2.8%）或在被诊断为高血压后血压得到控制（马萨诸塞州：74.52%，全国：69.7%）。结果表明，Synthea在模拟人口统计数据和在平均医疗保健环境中提供服务的概率方面非常可靠。然而，它的能力，异构健康结果建模后的服务是有限的。合成和其他合成患者generators. Synthea目前没有模型的护理偏差和潜在的结果，可能会导致护理偏差。为了输出更真实的数据集，我们建议合成数据生成器在临床医生可能偏离标准实践时，应在其逻辑和模型中考虑重要的质量指标。
Clinical data synthesis aims at generating realistic data for healthcare research, system implementation and training. It protects patient confidentiality, deepens our understanding of the complexity in healthcare, and is a promising tool for situations where real world data is difficult to obtain or unnecessary. However, its validity has not been fully examined, and no previous study has validated it from the perspective of healthcare quality, a critical aspect of a healthcare system. This study fills this gap by calculating clinical quality measures using synthetic data.We examined an open-source well-documented synthetic data generator Synthea, which was composed of the key advancements in this emerging technique. We selected a representative 1.2-million Massachusetts patient cohort generated by Synthea. Four quality measures, Colorectal Cancer Screening, Chronic Obstructive Pulmonary Disease (COPD) 30-Day Mortality, Rate of Complications after Hip/Knee Replacement, and Controlling High Blood Pressure, were selected based on clinical significance. Calculated rates were then compared with publicly reported rates based on real-world data of Massachusetts and United States.Of the total Synthea Massachusetts population (n = 1,193,439), 394,476 were eligible for the "colorectal cancer screening" quality measure, and 248,433 (63%) were considered compliant, compared to the publicly reported Massachusetts and national rates being 77.3 and 69.8%, respectively. Of the 409 eligible patients, 0.7% of died within 30 days after COPD exacerbation, versus 7% reported in Massachusetts and 8% nationally. Using an expanded logic, this rate increased to 5.7%. No Synthea residents had complications after Hip/Knee Replacement (Massachusetts: 2.9%, national: 2.8%) or had their blood pressure controlled after being diagnosed with hypertension (Massachusetts: 74.52%, national: 69.7%). Results show that Synthea is quite reliable in modeling demographics and probabilities of services being offered in an average healthcare setting. However, its capabilities to model heterogeneous health outcomes post services are limited.Synthea and other synthetic patient generators do not currently model for deviations in care and the potential outcomes that may result from care deviations. To output a more realistic data set, we propose that synthetic data generators should consider important quality measures in their logic and model when clinicians may deviate from standard practice.