Longitudinal Data Discontinuity in Electronic Health Records and Consequences for Medication Effectiveness Studies.

Longitudinal Data Discontinuity in Electronic Health Records and Consequences for Medication Effectiveness Studies.
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DOI:
10.1002/cpt.2400
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发表时间:
2022-01
影响因子:
6.7
通讯作者:
Schneeweiss S
Schneeweiss S
中科院分区:
医学2区
文献类型:
--
作者:
Joshua Lin K;Jin Y;Gagne J;Glynn RJ;Murphy SN;Tong A;Schneeweiss S

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电子健康记录(EHR)的不连续性,即在所研究的EHR系统之外接受医疗服务,可能导致基于EHR的真实世界证据(RWE)研究出现信息偏差。此前已经开发出一种算法来识别电子健康记录连续性高的患者。我们试图评估在4个RWE实例中,将此算法应用于患者选择以纳入研究是否能够减少由数据不连续性导致的偏差。在2007年至2014年年龄≥65岁的医疗保险受益人中,我们分别建立了四个队列来评估药物对短期或长期结果的影响。我们将索赔数据与两个美国的EHR系统相联系,并计算了仅基于EHR数据与基于关联的EHR - 索赔数据的多变量调整效应估计值的偏差百分比,因为关联数据涵盖了在研究的EHR系统之外记录的医疗信息。我们的研究队列在系统1中包括77288名患者,在系统2中包括60309名患者。我们发现电子健康记录连续性处于最低四分位数的亚队列涵盖了72 - 81%的短期结果事件,但仅涵盖21 - 31%的长期结果事件,导致短期结果实例的偏差百分比为6 - 99%,长期结果实例的偏差百分比为62 - 112%。这种趋势在使用非使用者比较而非积极比较的实例中似乎更为明显。在实证实例中,对于大多数亚组,我们没有发现因电子健康记录连续性而导致的治疗效果异质性具有显著性。在基于EHR的RWE研究中,研究人员可能会考虑排除算法预测的电子健康记录连续性低的患者,因为EHR数据所涵盖的他们的实际结果相对较少,并且这些患者的治疗效果估计可能不可靠。
Electronic health records (EHR) discontinuity, i.e., receiving care outside of the study EHR system, can lead to information bias in EHR-based real-world evidence (RWE) studies. An algorithm has been previously developed to identify patients with high EHR-continuity. We sought to assess whether applying this algorithm to patient selection for inclusion can reduce bias caused by data-discontinuity in 4 RWE examples. Among Medicare beneficiaries aged >=65 years from 2007 to 2014, we established four cohorts assessing drug effects on short-term or long-term outcomes, respectively. We linked claims data with two US EHR systems and calculated %bias of the multivariable-adjusted effect estimates based on only EHR vs. linked EHR-claims data since the linked data capture medical information recorded outside of the study EHR. Our study cohort included 77,288 patients in system 1 and 60,309 in system 2. We found the sub-cohort in the lowest quartile of EHR-continuity captured 72–81% of the short-term and only 21–31% of the long-term outcome events, leading to %bias of 6–99% for the short-term and 62–112% for the long-term outcome examples. This trend appeared to be more pronounced in the example using a non-user comparison rather than an active comparison. We did not find significant treatment effect heterogeneity by EHR-continuity for most subgroups across empirical examples. In EHR-based RWE studies, investigators may consider excluding patients with low algorithm-predicted EHR-continuity as the EHR data capture relatively few of their actual outcomes, and treatment effect estimates in these patients may be unreliable.
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