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PS1-43: Validation of Colony Stimulating Factor (CSF) Data within the HMORN Virtual Data Warehouse

机译:PS1-43:验证HMORN虚拟数据仓库中的菌落刺激因子(CSF)数据

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Background/AimsThe colony stimulating factors (CSFs), filgrastim and its long-acting form, pegfilgrastim, are indicated by the Food and Drug Administration to decrease infections in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy. Roughly 25-40% of treatment-naive patients receiving common chemotherapy regimens develop febrile neutropenia (FN). FN is associated with treatment delays, dose reductions, hospitalizations, and a high cost burden. CSFs decrease the incidence, length and severity of chemotherapy-related neutropenia in several solid tumors and prophylactically, decrease infection rates and neutropenia, infection-related mortality, and early deaths associated with chemotherapy. A reduction in absolute and relative risk for all-cause mortality is associated with CSF use and in combination with antibiotics for the treatment of FN, CSFs decrease the length of hospitalization; however, recent studies have shown these agents are frequently administered in a manner inconsistent with the recommended guidelines. The high costs associated with FN treatment, the high cost of CSFs and administration of CSFs in a manner inconsistent with scientific evidence creates both a clinical and economic challenge for health plans. To date, CSF data within the Virtual Data Warehouse (VDW) has not been evaluated for accuracy. MethodsWe are conducting a validation study using tumor registry data and medical record abstraction (gold standard) to evaluate 100 patients within our Cancer Center who received a new chemotherapy and initial treatment with a CSF from 01/01/2012-12/31/2012 with 100 patients matched on age, diagnosis, stage and treatment who did not receive CSFs to verify the VDW CSF data. We will compute the sensitivity, specificity, and positive predictive value of the VDW data to determine the concordance between the gold standard tumor registry and chart review data and the VDW data. ResultsChart review is currently ongoing and the VDW patient population is being assembled for comparison with abstracted data. ConclusionsUltimately, we plan to evaluate CSF use among HMORN sites and use CSF data within the VDW for studies among cancer patients within the HMORN.
机译:背景/目的食品和药物管理局指出,集落刺激因子(CSF),非格司亭及其长效形式pegfilgrastim可以减少接受骨髓抑制性化疗的非髓样恶性肿瘤患者的感染。约有25-40%的未接受过普通化疗的未治疗患者会出现发热性中性粒细胞减少症(FN)。 FN与治疗延误,剂量减少,住院和高昂的费用负担相关。脑脊液可降低一些实体瘤中与化疗相关的中性粒细胞减少症的发生率,持续时间和严重性,并预防性地降低感染率和中性粒细胞减少症,与感染相关的死亡率以及与化疗相关的早期死亡。全因死亡率的绝对和相对风险的降低与脑脊液的使用有关,并与抗生素治疗FN结合使用,脑脊液可缩短住院时间;但是,最近的研究表明,这些药物经常以与推荐指南不一致的方式给药。 FN治疗相关的高成本,CSF的高成本以及以与科学证据不一致的方式进行CSF的给药,给健康计划带来了临床和经济挑战。迄今为止,尚未评估虚拟数据仓库(VDW)中的CSF数据的准确性。方法我们正在使用肿瘤登记数据和病历摘要(金标准)进行验证研究,以评估我们癌症中心内100名从01/01 / 2012-12 / 31/2012开始接受新化学疗法和CSF初始治疗的患者。 100名年龄,诊断,分期和治疗匹配的患者未接受CSF验证VDW CSF数据。我们将计算VDW数据的敏感性,特异性和阳性预测值,以确定金标准肿瘤登记册和图表审查数据与VDW数据之间的一致性。结果目前正在进行图表审查,并且正在组装VDW患者人群以与抽象数据进行比较。结论最终,我们计划评估HMORN站点之间的CSF使用情况,并在VDW中使用CSF数据进行HMORN内癌症患者之间的研究。

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