Van Heertum Ronald L, Scarimbolo Robert, Wolodzko John G, Klencke Barbara, Messmann Richard, Tunc Feza, Sokol Levi, Agarwal Rajan, Strafaci James A, O'Neal Michael
Medical Affairs, Bioclinica, Inc., Princeton, NJ.
Medical Affairs, Sierra Oncology, Brisbane, CA.
Drug Des Devel Ther. 2017 Jun 13;11:1719-1728. doi: 10.2147/DDDT.S136988. eCollection 2017.
An operationalized workflow paradigm is presented and validated with pilot subject data. This approach is reproducible with a high concordance rate between individual readers (kappa 0.73 [confidence interval 0.59-0.87; =<0.0001]) using a 5-point scale to assess [F] labeled fluorodeoxyglucose metabolic activity in lymphomatous lesions. These results suggest an operationally practical 5-point scale workflow paradigm for potential use in larger clinical trials evaluating lymphoma therapeutics.
提出了一种可操作的工作流程范式，并通过试点受试者数据进行了验证。这种方法具有可重复性，使用5分制评估淋巴瘤病变中[F]标记的氟脱氧葡萄糖代谢活性时，个体读者之间的一致性率很高（kappa 0.73[置信区间0.59 - 0.87；<=0.0001]）。这些结果表明，一种在操作上实用的5分制工作流程范式可用于评估淋巴瘤治疗方法的更大规模临床试验。
