Thursday, September 8, 2016

--LOBXFL: a follow up

Recently, my French colleague Thierry Lambert noticed "It is often not possible to derive EPOCH in a generic manner: at baseline, you assign "SCREENING" to observations done on the day of treatment start because you know from the protocol and the CRF they were done before the first drug intake. The dates being the same, you cannot assign EPOCH automatically in this kind of case."

The same essentially applies to --LOBXFL: If you only know the date of the observation (without the time), and the observation is on the same date as the first exposure/treatment, you cannot know whether the observation was before or after the first exposure. So, it would essentially be impossible to assign a value of --LOBXFL at all, unless you know that the protocol stated that the observations had to be made before the first exposure, and you trust that the investigator did exactly as is stated in the protocol. However ... trust is good, control is better ...

So, I decided to slightly change the algorithm for assigning baseline "last observation before exposure" records in the "Smart Dataset-XML Viewer". What I did is that when the last observation before exposure is clearly before first exposure, either because for both the time part is available, or the observation was on another day, being before the first exposure day, then all is safe, and the record is marked as "last observation before exposure".

If however, we do not have the time of the observation, and the date is the same as the first exposure date, this means that we cannot be 100% sure that the observation was before the first exposure. In that case, we mark the record using a different color, and provide a tooltip providing a warning.

Let us take an example. First we inspect the DM dataset:

For subject 1015, we see that the date of first exposure is "2014-01-02". This indeed corresponds exactly with the earliest exposure record for that subject in EX.

Let us now take some laboratory (LB) records:

We see that some "last observation before treatment" records have automatically been assigned. For both in this picture, the observation date(time) is clearly before the date of first observation, and in both cases the following record is clearly after the first exposure date. So this is safe.
Let us also have a look at the vital signs (VS) dataset:

Also here, for the last "HEIGHT" measurement before first treatment, the assignment is safe, as the measurement was done a week before first treatment. A bit further we do however find:

We notice that the pulse rate measurements were performed on the same date as first treatment, but as no time part is given, we do not know exactly when. We could suppose that they were done before the first exposure, but we cannot be 100% sure. Even when the first exposures were exactly registered (including a time part), we still could not be 100% sure, as the VSDTCs all have a missing time part. So in this case, we are not safe.
So the software treats this differently, another background color is assigned, an a warning tooltip is provided.

Can the FDA tools do this?

I am uploading the new executables as well as the source code to SourceForge later today. Please feel free to use the software, use the source code in any way you would like. It's Open Source!

I think my next blog entry might get the title "--LOBXFL can seriously damage your health" ...

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