Dear Razeen

Sorry, I can't help you, it is totally outside my field.

thanks Dirk

Do a search for "adverse event" in the official REDCap forums (see link below), they have many workarounds there.

Instead of using a form for each episode of peritonitis, you could use one general adverse event form, add many adverse event variables (let's say 10), and use branching logic in order to hide the variables that aren't needed. You can always add more variables if needed.

Check out the REDCap shared library, you can find some useful templates for Adverse Events (there's even one with branching logic).

Hope this helps,

Hendrick.

https://groups.google.com/forum/?hl=en#!forum/project-redcap

https://redcap.vanderbilt.edu/consortium/library/search.php

Hello Razeen,

Several months ago I reasearched this problem as well, but I didn't find any ideal solutions. One person works on a trial that collects adverse events (AEs) used Arm 2 for AEs only. She put 20 AE forms on the schedule between each chemo visit. Of course, sometimes not all are used, and there could be more that 20 AEs in some periods. (I know you don't plan to use a schedule, but our databases currently do.)

I have only worked with AEs on a database custom-designed by a 3rd party, which was very simple to use. We had 100 to 150 AEs for some patients, and could always create another form to populate the AE list for each patient. Not so with RedCAP.

My project is to track surgical outcomes for patients as long as possible. I don't need AE forms specifically, but I do have a problem of needing an unknown number of forms to enter follow-up data. Our goal is to record follow up every 6 months at miniumum, so I have 8 full followup forms scheduled after surgery, then a "Survival Followup" listing page to list Name, Date, Status (NED, AWD, DOD, DOC), Treatment (if any), and a comment field to catch details that would vary from patient to patient. Not many patients are into these Survival listings yet, but the tests are working okay. (By "listing," I mean this form collects patient visits beyond the first 8, which are recorded on individual forms.)

To avoid a huge amount of missing data though, you need to use RedCAP logic, which is why my first 8 followup forms have about 10 fields but the ones on my Survival Listing form just have Name, Date, Treatment, Status, and Comments--because we will probably only sort by Name, Date, Treatment, or Status, and I can free-text search in Comments if we are careful about terminology and spelling. Clunky, yes. If you're collecting AEs for FDA, I'm sure you would have to have more searchable fields to generate reports.

Well, those are a few thoughts. The next decision is how many copies of the form you want to put on the page. I'm only doing 10, because I know that I can add without messing up prior data, as long as each successive form has unique field names (sur_status1, sur_status2...surv_status19 etc). Do you want to hide them unless you have data to enter? That should take your unused AE forms out of missing data.  I've tried it with unused survival follow-up, but I had a lot of tedious cleanup to get it right. My compromise--I do quality control on my required data and none of those fields are required.

In summary, I don't know a GOOD way to capture an unknown number of AEs, ConMeds, or Follow-Up visits in RedCAP!

--Suzanne

Thank you, Suzanne and Hendrick, for your very useful comments.

For now, I have decided to start with 10 separate but identical forms for peritonitis episodes and will see how this works.

Regards

Razeen

Razeen,

I would create a single instrument with the fields needed to be filled for each adverse event (AE). Then, I would activate the auto-numbering option in the Project Configuration window - this way each record in your instrument would be an adverse event.

Since you want to link each AE to a given person, make sure to add at least one individual identification field in the instrument. Hence, by creating a record (i.e. adverse event) you will fill the identification information such as the social security number (SSN) of the person to link their multiple records (AEs) afterwards. This way, each person can have 1 to many records (AEs), although you can filter by their unique identification number (SSN) to check how many and which AEs each person had.

Thank you very much Cauane, this is a really good suggestion.

Best regards

Razeen