My name is Gery and I am a registered nurse in Canberra Australia, caring for Oncology/Haematology patients undergoing cancer treatment with CAR T Cell therapy and bi specific antibody therapy.
I regularly document Cytokine release syndrome (CRS) and I am quite interested in developing an openEHR template that would capture instances of CRS, and structure it in a way that would be useful for clinicians (nurses, doctors, emergency department staff, community nurses) to pick up on possible patient episodes of CRS, and to inform them on what steps to take if a suspected episode is occurring.
Any input or directions is greatly appreciated
Kind regards
Gery
I’m not sure I understand your use case completely. Do you want to be able to document an identified episode of CRS, or document symptoms or signs in order to predict an episode before it happens? Or both, or something else entirely?
CRS is an adverse event that occurs after the infusion of specific drugs that is used to treat certain types of cancer.
So technically, I would like to be able to document episodes CRS, in a way that would inform the treating team so that the patient can be treated promptly, but also be able to pick up possible episodes of CRS when entering the patient’s observation readings (blood pressure, temperature and oxygen saturation).
So, this may still require you to organize your scenarios and needs, and then use CKM to collect the required raw forms, and utilize relevant modeling tools to build one or more templates aimed at meeting your needs.
Okay, that’s helpful. So how would you normally document an episode of CRS? For example, do you describe symptoms? Record specific vital signs such as the ones you mentioned? Do you observe the patient for a duration of time during and after the drug infusions? How long after the infusion do you normally get CRS episodes?
Agree - if you can provide a typical form or data collection protocol, this would be really helpful in orienting us to what you need.
A very common issue is that people go looking for something in ‘openEHR about CRS’ and do not find anything specific, when in fact most of the content probably exists already, e.g vital signs. symptoms etc - they just need to be shaped to fit your use case - which is where templates come in.
Currently we document/write notes on episodes of CRS using free text on our electronic health record system, that is after we identify that the patient is having a CRS episode based off the vital signs taken (low O2, low BP, high temperature).
A Grade 1 CRS is specified as having a fever (temperature equal to and greater than 38 degrees Celsius), with no hypotension and no hypoxia.
A Grade 2 CRS is specified as having a fever + hypotension (not requiring vasopressors, systolic BP is above 90 mmHg) + hypoxia (O2 saturation of 92% to 90% requiring low flow nasal cannula)
A Grade 3 CRS is specified as having a fever + hypertension (requiring vasopressors ± vasopressin) + hypoxia requiring high flow nasal cannula
(Pt to be transferred to ICU)
A Grade 4 CRS is specified as having a fever + hypotension requiring vasopressors including vasopressin + hypoxia requiring positive pressure (CPAP, BiPAP, intubation, mechanical ventilation)
The onset of CRS occurrence depends on the type of drug that is being administered, there are 2 types.
Bispecific antibodies can cause CRS within 4 to 16 hours post infusion, with some delayed onset up to 48 hours.
CAR T Cell therapy infusion can cause CRS within 2 - 3 days and lasting up to 8 days.
Thank you for the responses, very much appreciate the replies!
Okay, I quickly made up a rough template from my understanding of the requirements. It enables documenting the monitoring interval during and after administration of the drug, whether a reaction occurred, as well as details of the reaction and associated vital signs measurements.
(I also made up the CRS grading archetype, but the other archetypes in the template are all published ones)
Certainly, this is how new archetypes are born and teased out. Not all newbies know. Even the oldies among us sometimes need a reminder to not use archetypes in draft status.
The following diagram is taken from Hay on FHIR, showing the typical structure of a FHIR based clinical document. Maybe it would also help you understand your requirements and show how to build your template(s) using openEHR Archetypes, although the diagram for FHIR document.
Hi Silje, thank you for your reply!
I am having some difficulty re-creating the template with some additional requirements using Better, would you happen to be available for consultation via email or direct message by any chance?
I’m unfortunately not available for consultation work, but you may have better (no pun intended) luck with this template file set: Cytokine release syndrome monitoring.zip (239.1 KB)
If you have further questions, both myself and others will be happy to respond here in this topic
Thank you Silje, and everyone who responded to my post.
I have made an attempt of a draft of the CRS template, and would like inputs from the experts here on whether I have done it properly or if it needed corrections.
Unfortunately new users like me are not allowed to upload files, I am wondering how I would be able to show my work for the community to see if what I have done is correct or not.
Hi - the easiest approach is to generate a link to the template in Archetype Designer - this allows people ot view the template read-only. Otherwise, create an Export→ Template Fileset as a zip file and link to that e.g in Google Drive/Dropbox etc
This looks pretty good @Gery_Sinaga. Remember that you can use the template layer to ‘remove’ optional data points from the archetypes that you do not require - do this by setting occurrences to 0..0. There is also a quick button to set 0..1 on the node toolbar.
Thank You for Your feedback Ian, very much appreciated!
I would like to also know, is there a way for me to test out my draft template in a sandbox-like environment that would allow me to check whether it’s functioning as I intended it to be (or whether it’s functioning at all) ?.
