Is there a role for more than one test case in pre-trial outlining assessment?


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Sarah Gwynne1,2, Emiliano Spezi2, George Joseph2, Chris Hurt3, John Staffurth2, Tom Crosby2,4
1Singleton Hospital, Swansea, UK, 2Velindre Cancer Centre, Cardiff, UK, 3Wales Cancer Trials Unit, Cardiff, UK, 4Cardiff University, Cardiff, UK

Background

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.

Method

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.

Results

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.

Conclusion

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.