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Title

Mini-Mental State Examination (MMSE)

CDISC ReferenceFunctional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

MMSE

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2023-0307-2919
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

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Revision History

DateVersion
2023-0307-29191.0 Draft

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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 0 for incorrect answers. The sum of the 30 tasks is captured as a total score (0-30).

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The MMSE user manual requires a purchase and could not be obtained, so no statements are made on missing data. ADaM analysis will follow the user manual rules as needed to check against the collected score, based on the rules.

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     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 subscore for ubtotal for either one of the two sets of questions used is represented by 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. Items are divided into 11 subcategories represented in FTSCAT: "ORIENTATION TO TIME", "ORIENTATION TO PLACE", "REGISTRATION", "ATTENTION AND CALCULATION", "RECALL", "NAMING", "REPETITION", "COMPREHENSION", "READING", "WRITING", and "DRAWING".

  3. One item on the MMSE may be conditionally branched per the instrument instructions. Alternative item (WORLD backward) should only be administered if the examinee refuses to perform the Serial 7s task. A record is created in rs.xpt for all items. When an item is considered a conditionally branched item, it is represented as follows:

    1. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y” (this is a QS supplemental qualifier variable related to the record).
    2. QSORRES, QSSTRESC, and QSSTRESN are set to null (missing).
    3. QSREASND = "SUBJECT REFUSED TO ANSWER"

  4. Records are created in qs.xpt for every collected item on the instrument: 

    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

    2. Due to the variability of copyright holder and public domain derived score generation processes, records are not included for derived subscores or total scores that are not provided.

  5. The MMSE instrument includes subtotal

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    and total scores that are considered as captured data on the CRF and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from the CRF.
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    1. Subtotal and total scores are represented in--ORRES, --STRESC, and --STRESNIf 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 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 4.1.8.1, Origin Metadata for Variables).
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    2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
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      It is the sponsors repsonsibility to do this verificstin based on the instrument's user manual or instructiosn from the copyright owner.
  6. 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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