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Note the below modeling approach applies to can be used in all body-system domains when abnormalities are identified through examination of an image produced by an imaging procedure.

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•  Controlled terminology: finalize the details for the test = Examination for Abnormality.
•  Team needs to think about the implication of this approach. The cardiovascular common data element projects (both CV-imaging common data element and Endpoints TAs) contained many "indicator" values such as the following: aneurysm indicator, Cusp Prolapse Indicator, Cardiac Muscle Hypertrophy Indicator, Aortic Coarctation Indicator, Mitral valve stenosis Indicator, Mitral valve regurgitation indicator, pleural effusion indicator, etc, where the responses are "Y/N". At the time (well, still) CDISC treated this type of data as "pre-specified findings" and the modeling approach was to create "XXX Indicator" type of questions. However, the question has always been: are there really "pre-specified findings" from observing an image? Did you plan to find an aneurysm from the chest CT scan? Did you plan to find pleural effusion in the pleural cavity? What was planned was a an imaging procedure, such as a chest CT scan, and during this diagnostic procedure, abnormalities were identified. The observed abnormalities are results from an examination of examining the image, then is it correct to treat them as TEST values these "results" as TESTs by creating pre-specified finding indicator questions, i.e. aneurysm indicator?
  •  If what we proposed below is the way forward, CDISC will move away from creating "Indicator" type of questions for findings resulted from examination of an image.

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