DBT FT Evaluation

Proposal

The Digital Breast Tomosynthesis profile has been nominated for advancement to Final Text. (Advocate: Antje Schroeder) Per the Final Text Process, Items in blue text below warrant Committee discussion.

Technical Committee Checklist

• Are all significant CPs against the profile "closed"?

• There are no open DBT CPs

• Are all significant CPs against the underlying standards "closed"?

• There are no DBT related CPs in DICOM

• Have all significant comments been CP'd or rejected?

• Yes

• Have all open issues listed in the Supplement been closed?

• The first open issue can be closed, the supplement is aligned with DICOM CP 1342
• Open issue 2 (Should the Evidence Creator participate in the For Processing Breast Projection X-Ray Images Option? If so what transactions and functionality should it be required to support) is still open. However I recommend closing it based on the following reasons:

• The current option text is written without involvement of the evidence creator actor and we have not received any feedback regarding this issue yet.
• These images are generated at the Modality and are the original data, which are used to generate the DBT slices. There is no need for an evidence creator to be involved.
• If this functionality should be needed later on, it can be added via the CP process, since it does not change any mandatory behaviour.

• Have all significant issues at Connectathon been dealt with?

• After checking with Lynn Felhofer and David Clunie, no issues have been raised at the Connectathon.

• Gather feedback from implementers via a formal questionnaire to Connectathon participants

• See above

• Has the Connectathon Project Manager been queried and significant issues addressed?

• See above

Technical Committee Consensus

• The Technical Committee agreed to continue with the Final Text Process and continue with an evaluation by the Planning Committee

Planning Committee Checklist

• Has the profile been through a Connectathon in at least two regions?

• Yes (NA 2015 and 2016, and EU 2015 and 2016)

• Has the profile been successfully tested with all actors at least at one Connectathon?

• All major actors (Acquisition Modalities, Image Displays, Evidence Creators and Image Manager/Archives) have been tested. However Print Composers and Servers have not been tested

• Acquisition Modalities: GE, Fuji, Siemens
• Image Manager Archives: Agfa, GE, Dell, McKesson, Karos, Laitek, Visus, ...
• Image Displays: Tiani, Sectra, McKesson, Siemens, ...
• Evidence Creator: GE

• Even though the printer actors have not been tested in the scope of the DBT profile, they have been tested in the context of the Mammo Image profile. The functionality for printing the two different object types (Mammography Image and For Breast Tomosynthesis Image SOP Instances) is mainly the same. Difference in requirements pertain only to different attribute locations from which certain information has to be obtained. Therefore I would suggest to keep the two printing related actors as part of this profile.

• Have different implementations of each actor in the profile been tested?

• Yes (see above)

• Have all the options been tested successfully at at least one Connectathon?

• None of the options have been tested at the Connectathon. Options would be to either move them from the profile and get them in through CP later on if needed, or to keep them if functionality seems to be straight forward
• Evaluation of options

• Key Images option: This option is based on grouping with respective actors from the Key Image Note profile. The profile was frequently tested at Connectathons and the functionality is well understood. Therefore I would suggest to keep this option, since it does not impose any risks to keep it.
• Media Creation option: This option is based on grouping with respective actors from the Portable Data for Imaging profile. The profile was frequently tested at Connectathons and the functionality is well understood. The only additional requirements include viewers on the media, however addition of viewers is optional behavior. Therefore I would suggest to keep this option.
• User Annotation option: This option is based on grouping with respective actors from the Consistent Presentation of Images profile. The profile was frequently tested at Connectathons and the functionality is well understood. Therefore I would suggest to keep this option, since it does not impose any risks to keep it
• Partial View option: This option has been available in the Mammo Image Profile. The functionality is the same, therefore I would suggest to keep the option for symmetry reasons.
• For Processing and For Presentation Breast X-Ray Images options. These options define support (creation, storage and display) for two additional SOP classes, which is different from the other SOP classes, therefore I would suggest to remove them from the profile for now.

• Are there IHE-provided software testing tools to address all aspects of the profile?

• No specific test tools have been developed for the DBT profile, however existing tools are sufficient to cover the main aspects of the profile. Therefor this is not hindering, making the profile final text.

• Have the standards underlying the profile been implemented? In similar use cases? In healthcare? In general IT?

• The Breast Tomosynthesis Image Storage SOP Class has been supported by major vendors in this area.

• (Do you have concrete reason to believe that this works robustly in the Real World) / (Are any products available for purchase that implement the profile?)

• This profile is building upon the highly successful Mammography Image Profile and extends it to support Breast Tomosynthesis, which is gaining more and importance. Therefore it is assumed that the demand and support for this profile will increase.

• Have all issues that may have been raised about the profile been resolved?

No issues have been raised

• Has there been sufficient interest in the profile to generate a one-page overview of the profile

Yes, see DBT overview