Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Pharmacoepidemiol Drug Saf. 2023 May;32(5):586-591. doi: 10.1002/pds.5597. Epub 2023 Feb 16.
To determine the accuracy of International Classification of Diseases- Tenth Revision (ICD-10) diagnosis codes for rheumatoid arthritis (RA) serostatus using a U.S. claims database (Optum Clinformatics Data Mart, Optum) and to compare the results to a previous validation study performed in IBM Marketscan Research Database (sensitivity 73%, positive predictive value, PPV, 84%).
In Optum (01/01/2016-03/31/2020) linked with laboratory results, we selected RA patients based on ≥2 ICD-10 diagnosis codes for RA (M05 or M06) and at least one dispensing of RA treatments. We included individuals with at least one laboratory result for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) performed 365 days prior to and including the cohort entry date. An individual was "seropositive" if at least one of the 2 diagnosis codes used to define RA status was M05. "Seronegative" patients were required to have only M06. Secondary analyses were performed using subsets of M05 and M06 diagnosis codes. We calculated the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa of M05 and M06 against the prespecified reference standard laboratory data.
We identified 14 490 adult RA patients who had at least 1 RF or anti-CCP result. The number of patients identified for each reference standard definition ranged from 3315 (reference standard definition: high + anti-CCP) to 13 636 (any + RF). PPV for seropositive RA, M05, was 77.1%. The PPV of M06 for seronegative RA was 61.6%. When we applied more restricted definitions of M05 and M06, the PPV for seropositive RA increased to 79.2%. The PPV for seronegative RA also notably increased to 89.5%.
ICD-10 codes (M05 and M06) can help identify RA serostatus in claims data, but their limitations should be acknowledged. The PPVs for seropositive and seronegative RA found in the Optum database were lower than those found in MarketScan, perhaps related to database variability or differing patient characteristics and clinical practice. When more restricted definitions of M05 and M06 were used, the PPVs for seropositive and seronegative RA improved to 79.2% and 89.5%, respectively.
使用美国索赔数据库（Optum Clinformatics Data Mart，Optum）确定国际疾病分类第十版（ICD-10）诊断代码对类风湿关节炎（RA）血清状态的准确性，并将结果与之前在 IBM Marketscan Research Database 进行的验证研究进行比较（敏感性为 73%，阳性预测值，PPV，84%）。
在 Optum（2016 年 1 月 1 日至 2020 年 3 月 31 日）中，我们结合实验室结果，根据至少 2 个 RA 的 ICD-10 诊断代码（M05 或 M06）和至少一种 RA 治疗药物的配药，选择 RA 患者。我们纳入了至少有一次实验室检测结果的个体，结果为类风湿因子（RF）或抗环瓜氨酸肽（CCP），检测时间在队列入组日期之前 365 天内或包括该日期。如果至少有一个用于定义 RA 状态的 2 个诊断代码之一为 M05，则个体被定义为“血清阳性”。“血清阴性”患者需要仅为 M06。我们使用 M05 和 M06 诊断代码的子集进行了二次分析。我们计算了 M05 和 M06 对预设参考标准实验室数据的敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）和kappa。
我们确定了 14490 名成年 RA 患者，他们至少有一次 RF 或抗 CCP 结果。根据每个参考标准定义确定的患者数量从 3315 人（参考标准定义：高+抗 CCP）到 13636 人（任何+RF）不等。血清阳性 RA（M05）的 PPV 为 77.1%。血清阴性 RA 的 M06 的 PPV 为 61.6%。当我们应用更严格的 M05 和 M06 定义时，血清阳性 RA 的 PPV 增加到 79.2%。血清阴性 RA 的 PPV 也显著增加到 89.5%。
ICD-10 代码（M05 和 M06）可用于在索赔数据中识别 RA 血清状态，但应承认其局限性。在 Optum 数据库中发现的血清阳性和血清阴性 RA 的 PPV 低于 MarketScan 中的 PPV，这可能与数据库变异性或不同的患者特征和临床实践有关。当使用更严格的 M05 和 M06 定义时，血清阳性和血清阴性 RA 的 PPV 分别提高到 79.2%和 89.5%。
