Real-world evidence derived from electronic health records (EHRs) is increasingly recognized as a supplement to evidence generated from traditional clinical trials. In oncology, tumor-based Response Evaluation Criteria in Solid Tumors (RECIST) endpoints are collected in clinical trials. The best approach for collecting similar endpoints from EHRs remains unknown.We evaluated the feasibility of a traditional RECIST-based methodology to assess EHR-derived real-world progression (rwP) and explored non-RECIST-based approaches. In this retrospective study, cohorts were randomly selected from Flatiron Health's database of patient-level EHR data in advanced non-small cell lung cancer. A RECIST-based approach was tested for feasibility (N=26). Three non-RECIST abstraction approaches were tested for feasibility, reliability, and validity (N=200): (1) radiology-anchored, (2) clinician-anchored, and (3) combined.RECIST-based cancer progression could be ascertained from the EHRs of 23% of patients (6/26).In 87% of patients (173/200), at least one rwP event was identified using both the radiologyand clinician-anchored approaches. rwP dates matched 90% of the time. In 72% of patients (124/173), the first clinician-anchored rwP event was accompanied by a downstream event (e.g., treatment change); the association was slightly lower for the radiology-anchored approach (67%; 121/180). Median overall survival (OS) was 17 months (95% confidence interval [CI]: 14, 19). Median real-world progression-free survival (rwPFS) was 5.5 (95% CI: 4.6, 6.3) and 4.9 months (95% CI: 4.2, 5.6) for clinician-anchored and radiology-anchored approaches, respectively. Correlations between rwPFS and OS were similar across approaches (Spearman's rho: 0.65-0.66). Abstractors preferred the clinician-anchored approach as it provided more
Evaluation of long t e r n growth response to hGH treatment. The growth velocity (GV, cm/y) Induced by hGH treatment was evaluated i n 85 h(;H deficient patients classified i n t o 4 groups. Gr. A: Isolated hGH deflclency (IGHD), males, n-22; age a t s t a r t o f therapy (age): 0.8-19.6 (~9. 6~). Gr. B: IGHD, females, n= 19; age 0.4-16.9 y (mm8.6 yf. Gr. C: Multiple p i t u i t a r y h o m n e deficiencies (MPHD). males, n-30; age 1.3-21.4 y (r11.7 y). Gr. D: MPHD, females, n. 14; age 2.5-18.3 y (~1 0. 3 y). Followup ranged from 1-12 y with actual treatment amountlng t o 40-601 o f the tlme. Treatment was given I n courses o f 3-24 months. 2-6 Ux3/wk with intervals o f 2-14 mos. The regresslon equation o f GV (cm/y) as a function o f age and age2 was calculated using program BKIPPR (Dixon & Brown, 1979). The2fonnula i s : GV = K1 + K2 x Age + K3 (Age-12.5) K1 K2 K3 roUP
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