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Revision History

© 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 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 submission values.

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Adapted and reproduced by special permission of the Publisher, Psychological Assessment Resources, Inc. (PAR), 16204 North Florida Avenue, Lutz, Florida 33549, from the Mini Mental State Examination, by Marshal Folstein, MD and Susan Folstein, MD, Copyright 1975, 1998, 2001 by Mini Mental LLC, Inc. Published 2001 by Psychological Assessment Resources, Inc. Further reproduction is prohibited without permission of PAR, Inc. The MMSE can be purchased from PAR, Inc. online at www.parinc.com, or by calling (813) 968-3003.

3 The FT Domain Model

3.1 Assumptions for FT Domain Model

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The MMSE 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. The sum of the 30 tasks are captured 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 serial 7s and WORLD questions, the numeric rating is " 0-5", and the sub-score for these questions is represented where FTTESTCD="MMS104". For the MMSE, 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 instrument includes a total score that is considered as captured data on the CRF and is 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 score 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.

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The MMSE example below shows the terminology used to implement the instrument in the FT domain. This example shows the data for two subjects collected at the baseline visit for a and 1 subject that did not fill out the MMSE 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 questionsitems, subtotal and total scores from the MMSE forminstrument. USUBJID = "2324-P0001" performed the serial 7s portion of the MMSE. USUBJID = "2324-P0002" refused the serial 7s portion of the MMSE but performed the WORLD spelled backwards portion instead. USUBJID="2324-P0003" did not perform the MMSE.

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FTTESTCD = "MMS113"  FTTEST  FTTEST = "MMS1-Level of Consciousness"

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