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© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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Psychological Assessment Resources, Inc. (PAR) owns the copyright for the MMSE-2 STANDARD VERSION instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. PAR will distribute the CDISC supplement package to sponsors when they are approved to use this instrument. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the functional test. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) case report form(s) annotated with the CDISC SDTMIG variables with submission values. 

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MMSE-2 STANDARD VERSION is widely used to assess cognitive impairment and its progression over time. It includes 30 tasks that are scored as a " 1 " for correct answers and zero 0 for incorrect answers. There is a brief version score ("0-16") at the bottom of the first page which is the sum of the first 16 tasks. The sum of the full 30 tasks is captured at the bottom of the second page as a total score ("0-30").

1.  The scale points include a numeric rating ("0-1") and a description of what is represented by the rating (e.g., " 0 " = "INCORRECT", " 1 " = "CORRECT"). For the MMSE-2 STANDARD VERSION, FTORRES is populated with the text description of "INCORRECT" or "CORRECT". The numeric rating is represented in FTSTRESC and FTSTRESN. The actual result answers to each question are not represented in the dataset, only whether the answer is "CORRECT" or "INCORRECT" is represented.
   

2. The MMSE-2 STANDARD VERSION instrument includes a brief version total score and a standard version total score that are considered as captured data on the CRF and are not considered as derived in the example below.

   1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotal and total scores. An investigator derived score written on a CRF will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to Y. However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null [See SDTMIG Section 4, 4.1.8.1, Origin Metadata for Variables].

3. Terminology:
   

   1. FTCAT, FTTESTCD and FTTEST values are included in CDISC controlled terminology.

   2. A full list of value sets for result field is provided in Section 4: , SDTM Mapping Strategy.

3.2 Example for the MMSE-2 STANDARD VERSION FT Domain Model

The MMSE-2 STANDARD VERSION example below shows the terminology used to implement the instrument in the FT domain. This example shows the data for one subject 2 subjects collected at the baseline visit for a MMSE-2 STANDARD VERSION instrument. The example uses CDISC controlled terminology for FTTESTCD, FTTEST, and FTCAT. All original results are represented with preferred terminology in FTORRES. This result is then transformed into the standard numeric score in FTSTRESN and a character representation of the standard numeric score in FTSTRESC.

The table represents the questions from the MMSE-2 STANDARD VERSION forminstrument. Rows 31 and 32 show the brief and standard total raw scores for USUBJID = "2324-P0001". USUBJID="2324-P0002" did not perform the MMSE.

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FTTESTCD = "MMS214"   FTTEST = "MMS2-Level of Consciousness"

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