Wariar Ramesh, Wen Gezheng, Jacobsen Caroline, Ruble Stephen, Boehmer John P
From the Boston Scientific Corporation, Rhythm Management Division, Arden Hills, Minnesota.
From the Boston Scientific Corporation, Rhythm Management Division, Arden Hills, Minnesota.
J Card Fail. 2022 May;28(5):756-764. doi: 10.1016/j.cardfail.2021.11.008. Epub 2021 Nov 11.
Although claims data provide a large and efficient source of clinical events, validation is needed prior to use in heart failure (HF) diagnostic development.
Data from the Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients (MultiSENSE) study, used to create the HeartLogic HF diagnostic, were linked with fee-for-service (FFS) Medicare claims. Events were matched by patient ID and date, and agreement was calculated between claims primary HF diagnosis codes and study event adjudication. HF events (HFEs) were defined as inpatient visits, or outpatient visits with intravenous decongestive therapy. Diagnostic performance was measured as HFE-detection sensitivity and false-positive rate (FPR). Linkage of 791 MultiSENSE subjects returned 320 FFS patients with an average follow-up duration of 0.94 years. Although study and claims deaths matched exactly (n = 14), matching was imperfect between study hospitalizations and acute inpatient claims events. Of 239 total events, 165 study hospitalizations (69%) matched inpatient claims events, 28 hospitalizations matched outpatient claims events (12%), 14 hospitalizations were study-unique (6%), and 32 inpatient events were claims-unique (13%). Inpatient HF classification had substantial agreement with study adjudication (κ = 0.823). Diagnostic performance was not different between claims and study events (sensitivity = 75.6% vs 77.6% and FPR = 1.539 vs 1.528 alerts/patient-year). HeartLogic-detected events contributed to > 90% of the HFE costs used for evaluation.
Acceptable event matching, good agreement of claims diagnostic codes with adjudication, and equivalent diagnostic performance support the validity of using claims for HF diagnostic development.
尽管索赔数据提供了大量且高效的临床事件来源，但在用于心力衰竭（HF）诊断开发之前需要进行验证。
来自门诊心力衰竭患者多传感器慢性评估（MultiSENSE）研究的数据（用于创建HeartLogic HF诊断）与按服务收费（FFS）的医疗保险索赔相关联。通过患者ID和日期匹配事件，并计算索赔原发性HF诊断代码与研究事件判定之间的一致性。HF事件（HFEs）定义为住院就诊或接受静脉充血治疗的门诊就诊。诊断性能以HFE检测敏感性和假阳性率（FPR）衡量。791名MultiSENSE受试者的数据关联返回了320名FFS患者，平均随访时间为0.94年。尽管研究和索赔中的死亡情况完全匹配（n = 14），但研究住院情况与急性住院索赔事件之间的匹配并不完美。在总共239起事件中，165例研究住院病例（69%）与住院索赔事件匹配，28例住院病例与门诊索赔事件匹配（12%），14例住院病例是研究中独有的（6%），32例住院事件是索赔中独有的（13%）。住院HF分类与研究判定有高度一致性（κ = 0.823）。索赔事件和研究事件之间的诊断性能没有差异（敏感性 = 75.6%对77.6%，FPR = 1.539对1.528次警报/患者年）。HeartLogic检测到的事件占用于评估的HFE成本的90%以上。
可接受的事件匹配、索赔诊断代码与判定的良好一致性以及等效的诊断性能支持使用索赔数据进行HF诊断开发的有效性。
