I’ve been working on what is probably not the first (nor the last) implementation of RECIST v.1.1 in OpenClinica. The CRF setup is that target lesions are recorded in rows of a grid on one tab, and sum of lesion measurements field is on the following tab. I’d like to have some way to check that the measurements are totalled correctly by the user. Attached are a couple of screen shots of the CRF to illustrate.
- group-calculations don’t work if there is a null value in the array (the field returns ‘’), and
- the value of zero for measurements has a meaning (complete disappearance of the lesion) so zero can’t be used to avoid null, and
- it is appropriate to have a null value in some cases (the lesion was not assessed at the visit), and
- subjects can have 1, 2, 3, 4 or 5 target lesions evaluated throughout the study, but are only expected to add ‘enough’ rows;
the solution I’m thinking of is to write a rule to check whether or not the sum the user has entered is correct. However, rules also fail to run when null values are in the array, so I can’t just write the equivalent of:
‘does lesion 1 value + lesion 2 value + lesion 3 value + lesion 4 value + lesion 5 value = target lesion sum field’
So the rule it seems I need to write has to cover all the cases of there being a value and there being a null, for a minimum of 1 and maximum of 5 lesions, e.g.
- 1 lesion recorded:
- does lesion 1 value = sum
- 2 lesions recorded:
- does lesion 1 value + lesion 2 value = sum,
- does lesion 1 value = sum if lesion 2 value is null,
- does lesion 2 value = sum if lesion 1 value is null
- 3 lesions recorded:
- does lesion 1 value + lesion 2 value + lesion 3 value = sum,
- does lesion 1 value + lesion 3 value = sum if lesion 2 value is null,
- does lesion 2 value + lesion 3 value = sum if lesion 1 value is null
... and so on for all the combinations, for up to 5 lesions. I think works out to about 30 cases.
Before I go off and give myself a headache by writing this gargantuan rule, I wanted to check if anyone out there had come across a similar problem and were willing to share their solution, or if anyone had any insights on writing this rule that might simplify the rule expression.
Lindsay Stevens | Clinical Data Coordinator
NHMRC Clinical Trials Centre, THE UNIVERSITY OF SYDNEY
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tab with target lesion grid.JPG
tab with target lesion sum (response evaluation fields shown with rule).JPG
tab with target lesion grid.JPG 133 KB
tab with target lesion sum (response evaluation fields shown with rule).JPG 32.6 KB