Editorial checklist for clinical content review of archetypes


1.  Revise the archetype prior to sending out for a first review. Check the following:

  • The content of the archetype is consistent with its name - if the scope is incorrect at the beginning of the review, it will be harder to revise in the review process or after publication.  This is a good chance for a double check.
  • The scope of the archetype is for a single clinical concept
  • Focus is on universal use case.
  • Structure of data, protocol, state is tree for most situations.  This is not the default in older archetypes that are being revised.
  • Original author details are correct
  • Any comments that have been posted to CKM
  • Any ToDo tasks that have been entered by editors/administrators in CKM related to this archetype.
  • Identify any content within the archetype that has been modelled overtly here, but has subsequently been modelled as a separate archetype.  This will occur increasingly as we identify data that needs to be modelled for reuse in its own cluster or element archetypes.  Revise this content by adding a named slot in its place and including the appropriate archetype clusters or elements in the slot.
  • Identify specific questions that need to be clarified during the review process.

  2.  Identify potential members and create a team that will be assigned to reviewing this archetype:

  • All reviewers will be registered CKM users 
  • Include:
    • Any users who have adopted this archetype 
    • Technical experts as required and available - in order to
      • openEHR
      • HL7
      • Terminology
  • In addition, the best and most credible team will have the broadest range of professional expertise, health domain experience and geographical viewpoints as is possible.  Aim to balance the team by inviting other volunteer reviewers who:
    • enhance the scope of professions having input to the review - ensure a balance of generalists and specialists; medical, nursing, paramedical and others as appropriate;
    • broaden health domain experience - hospital, community, consumer;
    • provide input from a broad range of countries and cultures.

  3. Initiate the review:

  • Write a brief welcome and introduction to the review, highlighting the issues  and challenges and outlining timeframes.  This will form a major part of the invitation email sent out to potential reviewers and also be displayed at the beginning of the review process.
  • Select deadline times for reviewers to accept the invitation, and for completion of the review.
  • Insert special questions that are required as part of the review process.  In this way, you will either receive the feedback you have identified that you need to progress the archetype, or if no response, you will know that you need to seek answers external to the review group (and may need to expand the review team).
  • On initiation of the review, CKM will automatically set the status of the archetype to 'Team Review'.

 4.  CKM Notifications.

  • CKM will notify the editor of the following:
    • all reviewers who have been invited,
    • individual reviewer acceptance/decline of the invitation, and
    • when each reviewer has completed the review. 
  • In addition, CKM will send out a reminder to reviewers to complete their reviews 2 days prior to the completion deadline.

 5. Once the review deadline has passed, the editor can collate the feedback and revise the archetype based on the reviewer comments:

  • The archetype can be checked out for editing.
  • The editor can review the collective comments per data node, and for each special question. 
    • The editor can provide feedback on all the comments per datanode, and where appropriate make the required changes to the archetype.
    • If there is need for clarification the editor can email the reviewer directly requesting clarification
    • The feedback process can be saved and reopened on multiple occasions until the editor is satisfied that all issues have been completed.
  • The revised archetype can be checked back in to a branch in CKM, with appropriate comments outlining the changes made.  This can occur as many times as required, but will not be viewable by others until fully committed in the next step.
  • The revised archetype can be committed back to the main trunk for public view. 

 6.  The editor can initiate the next round of review on the revised archetype, and sending out the collated feedback, including the editorial response to each comment. 

 7. Steps 3 to 6 can be repeated as many times as is required until consensus is reached on the clinical content.

 8.  Once agreement is reached on the clinical content ie all (or the majority of, if consensus cannot be reached) reviewers 'Accept' the archetype, the status of the archetype can be set to 'Published'.

 9. Other reviewers can be added at any time in the review process, even in the middle of an existing review.

 10. Once the clinical content is agreed and fixed and thus effectively published, then additional work to incorporate translations and terminology coding can commence.

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In addition, consider the the same list provided to the reviewers, below.  In particular it will largely fall to the responsibility of the editor to ensure that the descriptions and options within the archetype are represented consistently, with similar phrasing, expression, grammar etc.

Concept  name

Is this appropriate?

Data - data elements

Are these complete?
Is there any content missing?
Are the datatypes appropriate?

Data - normal statements

Should normal statements be included in this archetype?
If present, are the normal statements appropriate?
What normal statements should be added?

Events

Should any event be available?
Are the specific point-in-time or interval events appropriate? 
What specific events should be added?
Are events present that only apply in limited use cases and should be left to a template?

Protocol

Are the Protocol data elements appropriate?
What other data elements should be added?

State

Are the State data elements appropriate?
Are the assumed values correct?
What other data elements should be added?

Slots

Are the slots named appropriately?
Are the ITEM archetypes selected as inclusions correct?
Are the ITEM archetypes selected as exclusions correct?

Comments

Check the correctness of any comments per data element

Cardinality

Check that cardinality is correct for Compositions, Sections, Clusters and Slots

Occurrences

Check the occurrences of data elements is correct

Metadata

Check completion and correctness of:

  • Concept Description
  • Purpose
  • Use
  • Misuse
  • References - Citation style
  • Keywords
  • Primary Author
  • Contributors

Punctuation and spelling

Check for correctness and consistency of punctuation and spelling

Phrasing and expression

Check for consistency of phrasing and expression, especially in data element naming and descriptions