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Title Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) CDISC Reference Functional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials QRS Short Name MMSE-2 STANDARD VERSION QRS Permission Status Approved Team CDISC Questionnaires, Ratings, and Scales (QRS) Subteam Supplement Version 1.0 Status DRAFT Date 2023-0809-1507 Notes to Readers This 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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© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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 0 for incorrect answers. There is a  brief version total raw score (0-16)

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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

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(0-30). With a standard version that is equivalent to the original MMSE and brief and expanded forms, the MMSE-2 retains clinical utility and efficiency while expanding the original’s usefulness in populations with milder forms of cognitive impairment, including subcortical dementia. 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.

1.  The scale points 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 subtotal for ubscore for either one of the two sets of questions used is represented by FTTESTCD = "MMS204". 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. 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. 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 or total overall scores that are not provided.

4. The MMSE-2 STANDARD VERSION instrument includes a brief version total raw score of the 1st 16 items and a standard version total raw score

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   that are considered as captured data on the CRF and are 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 Subscore and totaloverall scores are represented in--ORRES, --STRESC, and --STRESN.

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   2. If subscores and overall scores are received by the sponsor, it is recommended that they are submitted to SDTM andSDTM and verified in ADaM whenever feasible. It is the sponsors repsonsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.

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5. 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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