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Date and time

2018-12-17 20.00 UTC

Objectives

Discussion items


ItemDescriptionOwnerNotesAction
1Welcome & apologies
  • Remember recording!



2Conflicts of interest
  • None stated


3Previous minutes




4Susceptibility test products

Draft editorial guidelines: Editorial Guidelines for Diagnostic Products Used for Susceptibility Testing

It was decided to recommend representation the physical form of the susceptibility test product, and also to use the | has presentation strenght... | attributes (as opposed to other strength attributes).

Two issues were discovered while re-reading the Inception/Elaboration document for susceptibility testing: 1. "oral form antibiotic susceptibility" exists as components in LOINC tests. 2. when other methods than culture are used, e.g. PCR or sequencing, to determine susceptibility, we might need to use another way of modeling, e.g. beta-lactamase producing ~ resistance towards beta-lactam antibiotics.

While the Susceptibility test products are needed for the mycobacteria tests (with strength-specified antibiotics), we might reconsider the approach for other cases, and use substances where products are not needed, together with a role chain | towards | o | ingredient | → | towards |.

Rob: Aren't all susceptibility tests strength-specified, even though the strength is not part of the definition?

Xavier: EUCAST breakpoint for diffusion disks : http://www.eucast.org/clinical_breakpoints/ the xls is at http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Breakpoint_tables/Preliminary_v_9.0_Breakpoint_Tables_for_consultation.xlsx breakpoint requires a definite antibio amount in the disk.

Most tests (mycobacteria tests being an exception) are based on there being a concentration gradient (e.g. disk diffusion, etest, MIC procedures) and thus not a single concentration.


5MRCM rules update

See 2018-10-16 - OBSERVABLE Face-to-face Meeting, Item 6.

  • Update of | technique | to include | Assessment scale | in range.
  • Allow use of | direct substance | to model observables.

What are the requirements for testing MRCM change proposals?

  • Daniel Karlsson will provide some test examples for the | technique | attribute.

6Diastolic arterial pressure and how to go forward with existing Observables

See comments on this page.

The FSNs are generally under-specified compared to how concepts have been used. We need to decide whether to retire, rename, remodel, add or leave as is.

E.g. the blood pressure observables FSNs do not specify time aspect. Can we assume that they are single point in time or not?

The guidance given by the EAG was that we should allow more consideration of reasonable clinical interpretation and also to allow updating and clarification of FSNs if deemed necessary. Data concerning clinical use of the concepts should be used to inform decisions. Ambiguous concepts which are not in significant use may be retired.

As this might disrupt implementations the updated guidance should be discussed with the MF and CMAG. A briefing note has been sent out. Comments from MF and CMAG should be provided by 2019-01-31.



7New-project proposals

1) Pragmatic lab/clinical observables ontology for interoperation


2) Neuropathology database for Alzheimers disease registry

UNMC has received support for a new project including pathology/autopsy observables.



8Target observables


Copied from the Vital signs incept./elaborat. document:

Target observables

Among the 46680005 | Vital sign (observable entity) | observables, there are a few "target" observables: 428420003 | Target heart rate (observable entity) |, 315612005 | Target systolic blood pressure (observable entity) |, and 315613000 | Target diastolic blood pressure (observable entity) |. These concepts would not be considered vital signs according to the definition used in this document. While the representation of such targets have not yet been elaborated on, it is clear that a target observable is distinct from a "ordinary" observable, particularly true for e.g. 390734006 | Target weight (observable entity) | and 27113001 | Body weight (observable entity) |. There are related JIRA tickets: IHTSDO-457PCP-5IHTSDO-39 and also some potentially related tickets: IHTSDO-356IHTSDO-308.

Here is a presentation from a previous Observables meeting.

Here is an updated presentation. This was presented and discussed.

Likely, Observables and Settables should be disjoint.

Quick comments during the meeting supported the separation of "observation observables" from "observation targets".



10Observables for clinical trials


11Next meeting
  • Next meeting will be 2019-01-21



12AOB
  • Season's Greetings


Meeting Files

  File Modified
PDF File 07.0 Briefing Note Observables.pdf 2018-Dec-14 by Daniel Karlsson

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2 Comments

  1. here is the link to the EUCAST breakpoint for diffusion disks : http://www.eucast.org/clinical_breakpoints/

    the xls is at http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Breakpoint_tables/Preliminary_v_9.0_Breakpoint_Tables_for_consultation.xlsx

    breakpoint requires a define antibio amount in the disk.

    Xavier

  2. I am not able to edit the page so I am using a comment.

    For observable in trials: We hope to express trial lab results using SCT expression language. We have several datasets with CDISC CT lab results from Project Data Sphere. The main problem is that trial team may not have resources to fully express their lab tests and may simply use partial expression. (e.g., HIV viral load in blood).