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Research Article

Observer variability in a phase II trial – assessing consistency in RECIST application

, , , , &
Pages 774-780 | Received 13 Dec 2011, Accepted 02 Feb 2012, Published online: 21 Mar 2012

Figures & data

Figure 1. Study flow chart. Flow chart showing how the CT scans (396) of all the patients (100) were prospectively interpreted by the readers, while the study was on-going, and then reviewed by the reviewer after the study was closed.

Figure 1. Study flow chart. Flow chart showing how the CT scans (396) of all the patients (100) were prospectively interpreted by the readers, while the study was on-going, and then reviewed by the reviewer after the study was closed.

Table I. Categorisation of discrepancies between readers and reviewer. BOR: best overall response.

Figure 2. Example of a discrepancy between a reader and the reviewer. The reader chose a radio frequency (RF) ablation cavity as a target lesion (solid line) mistaking it for a measurable liver metastasis. The region in the rim of the large RF cavity is tumour tissue (dotted line). Differentiating tumour tissue from a RF cavity can be very difficult and requires training and sufficient information of previous treatment from the referring physician. The patient changed BOR from SD before the review to PR after the review.

Figure 2. Example of a discrepancy between a reader and the reviewer. The reader chose a radio frequency (RF) ablation cavity as a target lesion (solid line) mistaking it for a measurable liver metastasis. The region in the rim of the large RF cavity is tumour tissue (dotted line). Differentiating tumour tissue from a RF cavity can be very difficult and requires training and sufficient information of previous treatment from the referring physician. The patient changed BOR from SD before the review to PR after the review.

Table II. Agreement (bold writing) between readers and reviewer on best overall response (BOR) of all patients.

Table III. Changes in BOR after the review.

Table IV. Agreement (bold writing) between readers and reviewer on best overall response (BOR) of responding patients (PRc + PRu).

Table V. Number of CT scans per patient correlated to part of patients with discrepancies.

Table VI. Number of different readers per patient correlated to part of patients with discrepancies.

Supplemental material

http://informahealthcare.com/doi/abs/10.3109/0284186X.2012.667149

Download PDF (131.2 KB)

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