Department of Medicine, University of Alabama, 510 20th Street South, FOT 805D, Birmingham, AL 35294, USA.
Arthritis Res Ther. 2011;13(5):R155. doi: 10.1186/ar3471. Epub 2011 Sep 20.
Administrative claims data have not commonly been used to study the clinical effectiveness of medications for rheumatoid arthritis (RA) because of the lack of a validated algorithm for this outcome. We created and tested a claims-based algorithm to serve as a proxy for the clinical effectiveness of RA medications.
We linked Veterans Health Administration (VHA) medical and pharmacy claims for RA patients participating in the longitudinal Department of Veterans Affairs (VA) RA registry (VARA). Among individuals for whom treatment with a new biologic agent or nonbiologic disease-modifying agent in rheumatic disease (DMARD) was being initiated and with registry follow-up at 1 year, VARA and administrative data were used to create a gold standard for the claims-based effectiveness algorithm. The gold standard outcome was low disease activity (LDA) (Disease Activity Score using 28 joint counts (DAS28) ≤ 3.2) or improvement in DAS28 by > 1.2 units at 12 ± 2 months, with high adherence to therapy. The claims-based effectiveness algorithm incorporated biologic dose escalation or switching, addition of new disease-modifying agents, increase in oral glucocorticoid use and dose as well as parenteral glucocorticoid injections.
Among 1,397 patients, we identified 305 eligible biologic or DMARD treatment episodes in 269 unique individuals. The patients were primarily men (94%) with a mean (± SD) age of 62 ± 10 years. At 1 year, 27% of treatment episodes achieved the effectiveness gold standard. The performance characteristics of the effectiveness algorithm were as follows: positive predictive value, 76% (95% confidence interval (95% CI) = 71% to 81%); negative predictive value, 90% (95% CI = 88% to 92%); sensitivity, 72% (95% CI = 67% to 77%); and specificity, 91% (95% CI = 89% to 93%).
Administrative claims data may be useful in evaluating the effectiveness of medications for RA. Further validation of this effectiveness algorithm will be useful in assessing its generalizability and performance in other populations.
由于缺乏针对该结局的验证算法,行政索赔数据通常未用于研究类风湿关节炎 (RA) 药物的临床疗效。我们创建并测试了一种基于索赔的算法,作为 RA 药物临床疗效的替代指标。
我们将参与纵向退伍军人事务部 (VA) RA 登记处 (VARA) 的 RA 患者的退伍军人健康管理局 (VHA) 医疗和药房索赔联系起来。在开始使用新的生物制剂或非生物改善病情的抗风湿药物 (DMARD) 治疗且在 1 年内有登记随访的患者中,使用 VARA 和行政数据为基于索赔的有效性算法创建黄金标准。黄金标准结局是低疾病活动度 (LDA)(28 个关节计数的疾病活动评分 (DAS28) ≤ 3.2)或在 12 ± 2 个月时 DAS28 改善> 1.2 单位,同时具有较高的治疗依从性。基于索赔的有效性算法纳入了生物剂量升级或转换、添加新的改善病情的抗风湿药物、增加口服糖皮质激素的使用和剂量以及静脉内糖皮质激素注射。
在 1397 名患者中,我们在 269 名个体中确定了 305 例符合条件的生物制剂或 DMARD 治疗发作。患者主要为男性(94%),平均(±标准差)年龄为 62 ± 10 岁。在 1 年时,27%的治疗发作达到了有效性黄金标准。有效性算法的性能特征如下:阳性预测值,76%(95%置信区间 (95%CI) = 71%至 81%);阴性预测值,90%(95%CI = 88%至 92%);敏感性,72%(95%CI = 67%至 77%);特异性,91%(95%CI = 89%至 93%)。
行政索赔数据可能有助于评估 RA 药物的疗效。进一步验证该有效性算法将有助于评估其在其他人群中的普遍性和性能。