We are excited to announce that OHDSI is performing another important COVID-19 study titled “Adverse Events of Special Interest within COVID-19 Subjects”. Extending on our previous work by Li et al. (1,2) that brought understanding to the incidence rates of adverse events of special interest (AESI) for COVID-19, this work will look at the rates of these AESIs in patients who had COVID-19 disease.
Please note you are responsible for local information governance. This includes any arrangements regarding ethics and/or data access requirements.
We will be collecting results between, November 28, 2021 until January 1, 2022. In order to participate you need to email Erica Voss (evoss3 (at) its. jnj. com) who will provide you an appropriate data partner ID and provide the private key needed to load the results.
If anyone is interested in “Adverse Events of Special Interest within COVID-19 Subjects” and you haven’t heard from me over email, please email me at Erica Voss (evoss3 (at) its. jnj. com).
Well, it’s too late, since we don’t want to touch the protocol when the study is run. The confusion I see is this:
You don’t call problems resulting from a disease “Adverse events”. For drugs and interventions, there are the desired effects, and then there are those that are undesired, or adverse. Diseases have courses (all the bad things the disease brings) or complications (direct consequences not part of the direct course) or sequelae (later consequences).
This is is a semantic (or you may want to say pedantic) difference, but it makes it unclear what you are studying: the rates of those things as part of Covid, as a direct consequence of Covid, or as a later problem (Long Covid). Or any of the above?
You also discuss the TAR, which would explain your motivation, but I couldn’t find where it actually is declared. Is it?
@Christian_Reich yeah, I’ve gotten similar feedback that title is confusing. Will change it moving forward but didn’t want to update the protocol unless absolutely necessary.
The TARs are explained in Section 7.4:
We will include seven TARs, relative to the COVID-19 index date, for this work.
Days 0 – 2 (to capture accute events)
Days 1 – 7 days (One Week)
Days 1 – 14 days (Two Weeks - to align with COVID-19 symptoms appearing [7])
Days 1 – 21 days (Three Weeks - this will likely be the target TAR post vaccines)
, thx for letting me know it bounced. I fixed it above, please shoot me an email so I can send you additional information.
