What do I do when only half of the information in the CRF is supported by OMOP columns?

Implementers
1

Hi everyone,

I am very new to anything data related, so please forgive me if this is a very basic question.

I am helping plan the standardization of a CRF into the OMOP-CDM, and I ran into an issue. Please take a look at the following question:

“Has the subject experienced any relevant past and/or concomitant diseases / past surgeries that are considered to be clinically significant in the past 10 years?”

This is a simple yes or no question, and my understanding is that I can either create custom concepts and do my best to map them to standard concepts, or I could simply not map this question to any concept and any patient with an occurrence in the condition_occurrence table would be an automatic ‘yes’. No problem.

However, if the answer is yes, this of course creates a past condition to be placed in the condition_occurrence table. And indeed, these are the follow-up questions in the CRF:

IF YES, PLEASE RECORD BELOW: - History date
IF YES, PLEASE RECORD BELOW: - Date accuracy
IF YES, PLEASE RECORD BELOW: - Medical history detail
IF YES, PLEASE RECORD BELOW: - Medical history ongoing
IF YES, PLEASE RECORD BELOW: - End date
IF YES, PLEASE RECORD BELOW: - Date accuracy

Out of those, three of them aren’t covered by the columns in condition_occurrence: the ones about date accuracy, and the ‘medical history ongoing’. My understanding is that I can’t simply add a new column to the table without making a mess, so I was wondering if there was a workaround? I understand I could simply not include those in the standardization process, but I figured an answer to this could be relevant to other scenarios.

Thank you in advance!!

2

@Victor_Galvao:

The Clinical Trial Workgroup is the right place to discuss these. Because everybody has them.

However, the OMOP CDM doesn’t work like that where you can create any variable and combine variables with additional information. Every clinical fact, in this case a condition, that occurred at some time, is a single record with the condition encoded in the condition_concept_id, the date as condition_occurrence_start_date and the end date likewise as the condition_occurrence_end_date. No idea what “medical history ongoing” means, but probably if the condition is still going on. This is not necessary in OMOP. And “medical history detail” is completely undefined.

3

I understand, I will keep this in mind moving forward. Thank you!