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Revision History

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

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 CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards. The PAR provided CRF has updated the item names represented on the CRF that were described in the original reference.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Functional Tests (FT) domain model, which can be found at the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These The specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC web site at: https://www.cdisc.org/standards/foundational/qrs.

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CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols. CDISC disclaims any liability for your use of this material.

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CDISC acknowledges R. Bob Smith III, PhD, Chairman and CEO Psychological Assessment Resources, Inc., for the approval to include the MMSE in the CDISC data standards.

References for the MMSE:

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189‒198.

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• The PAR website reference for the MMSE is: https://www.parinc.com/Products/Pkey/237.

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 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 numeric rating is 0-5

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   626, and jira

   628

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    The original scores 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 either one of the two sets of questions used is represented by FTTESTCD = "MMS104". 628. 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 representedrepresented
   

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. As described on the CRF, an alternative item (spell 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 Flag “, 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 subscore and overall score generation processes, records are not included for derived subscores and overall scores that are not provided.

5. The MMSE instrument includes subtotalsubscore

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   and total scores overall score 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. Subscore and overall 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 subscores or overall scores are received by the sponsor, it is recommended that they are submitted to SDTM and SDTM and verified in ADaM.

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      It is the sponsors repsonsibility to do this verification based on the instrument's usesr manual or instructions 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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The table represents the items, subtotalsubscore, and total scores from the MMSE instrument. 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 at the scheduled visit.

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