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  • Total and Subscale Scores
    • Document instrument scoring instructions in define.xml.
    • Even if SDTM has computed a total score, keep a separate ADaM total score record in the analysis dataset. Also keep the total score from SDTM which has a different parameter.
    • Use of "concept domain" and "dimension" in a supplement should be consistent with any published scoring instructions or other references. However, if "dimension" appears in the published references, add "(concept domain)" in parentheses to the supplement the first time "dimension" is used so an individual reviewing and familiar with that terminology will understand that the two terms can be used interchangeably (or vice versa, if "concept domain" or "domain" appears in the published references).

Tabled Items

  • Need to develop list of expected variables for all ADQRS datasets.
  • How much manipulation can be done on AVAL for records coming from SDTM before a new parameter should be used instead of copying QSTEST/QSTESTCD into PARAM/PARAMCD?  For example, what if SDTM only collects character values (<=15 minutes, 15-30 minutes, etc.), but numeric codes are required for analysis- can those go into AVAL?  What would be imputed- the character or the numeric value?  Does this change if we are transforming or reversing collected scores for analysis?
  • How should author codes (question codes pre-printed on the instruments) be handled?  Sometimes the same question can be used on different instruments that are related;  if the data is being pooled across studies for integration, and some of the items are the same, it may be possible to combine data from those items via the author codes.
  • PARCAT1 holds the instrument name, and PARCATy holds the subscale name(s) associated with the item.  How should items contributing to multiple subscale calculations be modeled?