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  • PARCATy/PARAM/PARAMCD
    • Include PARCAT1 in ADQRS datasets in case multiple instruments are subsequently combined into a single dataset.  PARCAT1 contains the name of the instrument, and may come from QS.QSCAT.
    • PARCAT2 is allowed if needed, and should contain the subscale name (may come from QS.QSSCAT, but is driven by analysis/reporting needs).
    • Bring QSTEST and QSTESTCD directly into PARAM and PARAMCD, respectively, for maximum traceability back to QS.
    • Create new PARAM/PARAMCD values for subscale and total scores, and where items from different SDTM versions are combined for analysis purposes, such as CHART-SF, where the paper and interview versions are summarized together.  Submit requests for new PARAM/PARAMCD values to the QRS CT group.
    • When creating PARAMCD values for subscale scores, keep the SDTM QSTESTCD value, and abbreviate any published subscale codes.  Select values for PARCATy and PARAMCD such that the items are grouped in a logical order.
    • Use a completely different PARAMCD value for the computed total score than the SDTM QSTESTCD values.  That makes it easier to spot in the data set, and also distinguishes it from a collected total score that may be stored in SDTM.  For the GDS-SF, this will be called GDS02TS.  A new Controlled Terminology request should be submitted for computed score records.
  • AVAL/AVALC
    • Keep QSORRES, and use AVALC only if it differs from QSORRES.
    • Logically skipped items are now being captured in the QRS supplements (2021). We recommend that they are carried over from SDTM for traceability. In this case, the AVAL and AVALC is null, unless someone needs to summarize a count. In the latter case, we suggest to add AVALC of 'Logically Skipped Item' so that it may be counted. These items do not need to be carried over to additional summary datasets.

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  • Total and Subscale Scores
      Use a completely different PARAMCD value for the computed total score than the SDTM QSTESTCD values.  That makes it easier to spot in the data set, and also distinguishes it from a collected total score that may be stored in SDTM.  For the GDS-SF, this will be called GDS02TS.  A new Controlled Terminology request should be submitted for computed score records.
    • 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).

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