Department of Internal Medicine, The Ohio State University, A450B Starling Loving Hall Columbus, Columbus, OH, 43210, USA.
Department of Biomedical Informatics and Center for Biostatistics, The Ohio State University, A450B Starling Loving Hall Columbus, Columbus, OH, 43210, USA.
Cancer Immunol Immunother. 2021 Oct;70(10):2761-2769. doi: 10.1007/s00262-021-02880-0. Epub 2021 Feb 24.
The aim of this retrospective study was to demonstrate that irAEs, specifically gastrointestinal and pulmonary, examined through International Classification of Disease (ICD) data leads to underrepresentation of true irAEs and overrepresentation of false irAEs, thereby concluding that ICD claims data are a poor approach to electronic health record (EHR) data mining for irAEs in immunotherapy clinical research.
This retrospective analysis was conducted in 1,063 cancer patients who received ICIs between 2011 and 2017. We identified irAEs by manual review of medical records to determine the incidence of each of our endpoints, namely colitis, hepatitis, pneumonitis, other irAE, or no irAE. We then performed a secondary analysis utilizing ICD claims data alone using a broad range of symptom and disease-specific ICD codes representative of irAEs.
16% (n = 174/1,063) of the total study population was initially found to have either pneumonitis 3% (n = 37), colitis 7% (n = 81) or hepatitis 5% (n = 56) on manual review. Of these patients, 46% (n = 80/174) did not have ICD code evidence in the EHR reflecting their irAE. Of the total patients not found to have any irAEs during manual review, 61% (n = 459/748) of patients had ICD codes suggestive of possible irAE, yet were not identified as having an irAE during manual review.
Examining gastrointestinal and pulmonary irAEs through the International Classification of Disease (ICD) data leads to underrepresentation of true irAEs and overrepresentation of false irAEs.
本回顾性研究旨在证明，通过国际疾病分类（ICD）数据检查的 irAE，特别是胃肠道和肺部 irAE，会导致真实 irAE 被低估，而假 irAE 被高估，因此得出结论，ICD 索赔数据是免疫治疗临床研究中从电子健康记录（EHR）数据中挖掘 irAE 的一种不佳方法。
本回顾性分析纳入了 2011 年至 2017 年间接受 ICIs 治疗的 1063 例癌症患者。我们通过病历手动审查确定了 irAE 的发生率，以确定我们的各个终点，即结肠炎、肝炎、肺炎、其他 irAE 或无 irAE 的发生率。然后，我们使用 ICD 索赔数据进行了二次分析，使用了广泛的症状和疾病特异性 ICD 代码，代表了 irAE。
在总研究人群中，最初有 16%（n=174/1063）被发现患有肺炎（3%，n=37）、结肠炎（7%，n=81）或肝炎（5%，n=56）。在这些患者中，46%（n=80/174）的患者的 EHR 中没有反映其 irAE 的 ICD 代码证据。在手动审查未发现任何 irAE 的患者中，61%（n=459/748）的患者的 ICD 代码提示可能存在 irAE，但在手动审查中未被识别为存在 irAE。
通过国际疾病分类（ICD）数据检查胃肠道和肺部 irAE 会导致真实 irAE 被低估，而假 irAE 被高估。
