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(PDF) Breaking down the RECIST 1.1 double read var

时间:2025-08-22 11:07来源: 作者:admin 点击: 3 次
Background: In clinical trials with imaging, Blinded Independent Central Review (BICR) with double reads ensures data blinding and reduces bias in dru

We documented double read features (displayed by column) for the five clinical trials (displayed by row). The two left-most columns display discrepancy features. Only for patients reported as having measurable diseases, the three right-most columns display the means of each reader's measurements (independent reader [IR]1 and 2), the p-value of the corresponding two-sample test of difference is indicated by asterisks: **, p<0.001; *, p<0.05; no asterisk means no statistically significant difference. The last row is the average overall measurements of both R1 and R2 with corresponding confidence intervals. 60.5% (229/378) Lung: 38.6 LN: 20.6 Bone: 10.8 Pleura: 4.8 LN: 14.8 Bone: 12.4 Lung: 6.9 Pleura: 6.1

Overall (N= 1720) 43.5

1121/1720) Lung: 32.7 LN: 28.3 Bone: 12.0 Pleura: 7.6 LN: 20.1 Bone: 12.2 Lung: 10.1 Pleura: 8.4 LN, Lymph node; TL, Target lesion; NTL, Non target lesion. For the five clinical trials (displayed in rows) we computed: The proportion of patients for which readers targeted all their TLs in totally different locations (DisLocTLAll); the proportion of patients for which readers targeted at least one TL (DisTLLoc) or NTL (DisLocNTL) at a different disease location; the top proportion of discrepancies in TL (TopDisLocTL), NTL (TopDisLocNTL) and disease locations (TopDisLocDisease) (

SOD, Sum of Diamters; TLNum, Number of target lesion. For seven readers (displayed in rows) involved in two or more trials, we reported in column 1) the number of assessed patients at baseline, 2) the average number of TLs selected in patients, 3) the average measured SOD, 4) the proportion of patients for whom nodal, bone, lung, pleura and infrequent disease were evaluated. Confidence intervals are provided in brackets.

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