Is there a role for more than one test case in pre-trial outlining assessment?
Session type: Poster / e-Poster / Silent Theatre session
The pre-trial quality assurance (QA) programme for SCOPE 1, a UK chemoradiotherapy trial of oesophageal cancer, included an outlining assessment based on a single mid-oesophageal cancer case. The purpose of this study is to determine if outlining can be adequately assessed on this single case.
12 UK investigators who achieved a Jaccard Conformity Index (JCI) of ≥0.7 against a pre-defined reference volume in the SCOPE 1 pre-trial test case (case one) re-outlined a GTV on this and 2 further mid-oesophageal cancer cases on a total of 2 occasions. Reference volumes for case two and three were defined in the same way as case one (by GJ and TC). JCI values of ≥0.7 and <0.5 were considered to be excellent and poor concordance respectively.
Median JCI for the 1st and 2nd attempts at case one were 0.73 (IQR 0.71-0.74) and 0.72 (0.64-0.74), case two 0.67 (0.64-0.73) and 0.70 (0.64-0.72) and case three 0.65 (0.58-0.68) and 0.61 (0.57-0.67) respectively.
Only one investigator achieved a JCI of ≥0.7 on all outlining attempts. No investigator achieved a JCI <0.5 on their 1st attempt but 2 investigators achieved JCI <0.5 on their 2nd attempt at case two and three respectively.
This data shows that there are differences in investigator performance, as measured by JCI, between 3 different mid-oesophageal cases, suggesting that there may be a role for more than one outlining assessments in trial QA programmes. Excellent performance in a single case does not guarantee excellent performance in subsequent outlining attempts at the same or other cases.