How to store the reason of drug discontinuation in DRUG_EXPOSURE.stop_reason field

[jiawei-qian]

How to store the reason of drug discontinuation in DRUG_EXPOSURE.stop_reason field

CDM or THEMIS convention?

THEMIS

Table or Field level?

Field

Is this a general convention?

No

Summary of issues

1. In OHDSI Forum, someone want to store drug discontinuation reason in CDM v6.0 but found the DRUG_EXPOSURE.stop_reason is deprecated. Then how to store the stop reason now?

2. How to store the "drug suspension due to unknown reason" and "drug suspension due to adverse effect" in DRUG_EXPOSURE.stop_reason field?

Summary of answer

1. Now the active version is v5.4. Can use the stop_reason field in DRUG_EXPOSURE table.

For "drug suspension due to unknown reason" situation: need to fix the drug_exposure_end_date. If there is no reason, don't populate stop_reason field (rather than saying "no reason").
For "drug suspension due to adverse effect" situation: Christian says it's better not to store adverse effect reason into stop_reason field. Because the idea of the OMOP CDM and the expectation of the analyst, is to store the medical fact, not some intensions of some doctors.

For example, the patient stopped mesalazine due to nausea. Although there is a reason given here, but its value is low: Whether or not the nausea is due to the drug or something else - neither the patient nor the doctor knows. It’s a guess. At the end of the day it is not possible to know if something is an adverse effect. Only statistics of a population can tell us if there is a risk. Which means, it is the outcome of the research, not the input.

Bottom line: Write Nausea into CONDITION_OCCURRENCE at the date the drug was stopped and be done with it. Feel free to add it as a stop reason, but probably nobody will ever pick it up for research.

3. For fixing the drug_exposure_end_date, if we only know the decision (datetime) to stop the treatment was taken, but it does not specify when the action was applied? Christian suggests, typically, if the decision is taken it takes effect immediately.

Related links

OHDSI Forum: https://forums.ohdsi.org/t/alternative-to-v6-0-deprecation-of-cdm-drug-exposure-stop-reason-column/20905

Other comments/notes

Although Chtistian suggests not to store "adverse effect" reason into stop_reason field, he also says feel free to add it as a stop reason but probably nobody will ever pick it up for reasearch. In my opinion, some people/institutions may want to store stop reason for their own use. Thus, if we create THEMIS convension, I think we can say: although it is not suggested to store adverse effect into stop_reason field, it also depends on their own decision whether want to store adverse effect into stop_reason field.

A good idea is also to store the stop reason: adverse effect (e.g. Nausea) into the CONDITION_OCCURRENCE table.

[clairblacketer]

Thanks @jiawei-qian ! I think this is more of a CDM documentation issue so I am going to transfer it there.

[clairblacketer]

I am still thinking about how to document this one. I am going to move it to the needs more work column