ouhft / COPE

Project Repository for Work Package 4 of the COPE Transplant Trial
https://cope.nds.ox.ac.uk
1 stars 0 forks source link

Cold Storage Validation #146

Open marshalc opened 7 years ago

marshalc commented 7 years ago
1.  Cold storages: When a kidney is cold stored, no machine data will be entered. Forms can’t be closed without entering timings of kidney coming of the machine etc. There should be a formal box to check cold storage. Preparation of the previous DMC report also has taught us that cold storage kidneys (that do not adhere to trial requirements but are taken forward in the intention-to-treat-analysis) cannot be fished out of the database. 
 
=> In Github issue 45 it was mentioned that only when a kidney is machine perfused machine data are compulsory. 

There is a question that asks “Was the kidney cold stored?” in the online database but no record of an issue in the repository regarding the inability to close forms or a request to make changes to allow this.

There are only four checks in place on attempting to close a Transplantation Form, as agreed by Sarah and Ina on the v0.5.0 release sign off:

Solution as suggested needs to be reconsidered in light of what actually exists in the present system.

My guess is that the test for repercussion_started_at needs to have an additional condition related to the cold storage answer, but will need this confirmed by someone else. Until then, this issue is on hold.

mertenssarah commented 7 years ago

You could relate to information given in the donor form where you need to answer if the kidney was cold stored?

marshalc commented 7 years ago

So the proposed validation test would be:

reperfusion_started_at is empty AND organ_cold_stored is True (REv05)

Does that cover all eventualities?

ij-cope commented 7 years ago

@marshalc - No, reperfusion_started_at (REv05) refers to the organ being reperfused with blood at time of transplantation. It is a variable that has nothing to do with preservation.

Virginia has also let me know that - based on the data reports she received from Carl for the DMC preparation - she too has trouble finding which kidneys were cold stored by which we mean a kidney not placed on the machine or when the machine did not circulate the preservation fluid through the kidney (so a machine error). I have opened issue #166 to elaborate.

When the validation checks were set in place we did not keep in mind that some kidneys would not be able to undergo machine perfusion. Nevertheless, this has proven to happen in about 10% of cases.

REv02 can be removed for cold stored kidneys as this is a senseless question for these kidneys. For kidneys that were machine perfused REv01 and REv02 are, however, important data point. Issue #166 gives detail on how Cold Stored kidneys could be flagged for this validation rule as well as for the creation of data reports and easier data analysis.

Does this help?

marshalc commented 7 years ago

Modify REv02 and REv05 to be dependant on organ.was_cold_stored being false.

marshalc commented 7 years ago

This is related to further discussion in Issue #166. Hold off on pushing this change to test until 166 is resolved.

marshalc commented 7 years ago

Conditions for Cold Storage still need to be determined, following the Data Cleanup tasks to work out what constitutes actually cold stored, and for what context (i.e. partial cold storage vs only cold-storage)