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Event not scheduled because subject died

We have a CRF that has screening a pretreatment info at the beginning and the clinical reviews scheduled for +1hr, +4hrs, +8hrs, +24hrs and +48hrs. Let's say the clinical review CRF looks like this:
status: alive / dead
amount of fluid since last clinical review: ____ml
Take the example that the patient recieved fluid but died at 5 hours, you might have the following:
At +1hr you'd answer:
alive
250ml
At +4hrs you'd answer:
alive
250ml
At +8hrs you'd answer:
dead
70ml (because the patient did receive 70ml of fluid up until 5 hours when he died)
BUT thereafter you don't fill in the +24 and +48 hrs clinical reviews because he's now dead.
I have set up the events as Clinical Review + 1hr (non-repeating), Clinical Review + 4hrs (non-repeating), etc. That way OC gives me clear columns that show an orange icon if the event has had data entered and a blue icon if the event has not yet been scheduled. Firstly please comment on our architecture.
Secondly, the blue unscheduled icon is ambiguous for us because it can indicate to us either 1. we simply have not entered the data yet, or 2. we deliberately did not enter the data because we're trying to indicate that the subject has died. Does OC has an more elegant in-built way to show a subject has died? If not, and if we're on the right track here then what would you suggest as a very solid way to show that we have not scheduled the event because the subject has died?
Thanks,
Paul
Media & Software Studio
+254 736 998202

Comments

  • Hi Paul,

    OpenClinica does not have a status or way of showing the subject has died but let me know if the following work around will help you.

    There is a field called Secondary ID for study subjects, are you using this field right now? If not, you can enter Deceased (or any other value) in that field for this particular subject. In the unfortunate event you have another subject die, you can enter Deceased in the Secondary ID for the second subject because this field does not have to be unique per study subject.

    When you are in the subject matrix, you can select the Show More link. If you have version 2.5 or greater installed, you will see a column called Secondary Label. This is where the word Deceased would show up for the subject. A benefit to this work around is you could also sort by this column.

    Does anyone else on the list have any feedback for the way Paul set up his events in OpenClinica or other ways they have solved this problem?

    Thanks,
    Paul
    Sent: Thursday, December 18, 2008 7:58 AM
    To: [email protected]
    Subject: [Users] Event not scheduled because subject died

    We have a CRF that has screening a pretreatment info at the beginning and the clinical reviews scheduled for +1hr, +4hrs, +8hrs, +24hrs and +48hrs. Let's say the clinical review CRF looks like this:
    status: alive / dead
    amount of fluid since last clinical review: ____ml
    Take the example that the patient recieved fluid but died at 5 hours, you might have the following:
    At +1hr you'd answer:
    alive
    250ml
    At +4hrs you'd answer:
    alive
    250ml
    At +8hrs you'd answer:
    dead
    70ml (because the patient did receive 70ml of fluid up until 5 hours when he died)
    BUT thereafter you don't fill in the +24 and +48 hrs clinical reviews because he's now dead.
    I have set up the events as Clinical Review + 1hr (non-repeating), Clinical Review + 4hrs (non-repeating), etc. That way OC gives me clear columns that show an orange icon if the event has had data entered and a blue icon if the event has not yet been scheduled. Firstly please comment on our architecture.
    Secondly, the blue unscheduled icon is ambiguous for us because it can indicate to us either 1. we simply have not entered the data yet, or 2. we deliberately did not enter the data because we're trying to indicate that the subject has died. Does OC has an more elegant in-built way to show a subject has died? If not, and if we're on the right track here then what would you suggest as a very solid way to show that we have not scheduled the event because the subject has died?
    Thanks,
    Paul
    Media & Software Studio
    +254 736 998202
This discussion has been closed.