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© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) instrument.

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The CDISC Intellectual Property Policy can be found on the CDISC web site at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

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Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

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 FTTESTCD and FTTEST for each item based on the actual text on the functional test.

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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-2, by Marshal Folstein, MD and Susan Folstein, MD, Copyright 2010 by Mini Mental LLC, Inc. Published 2010 by Psychological Assessment Resources, Inc. Further reproduction is prohibited without permission of PAR, Inc. The MMSE-2 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

All assumptions and business rules described in the SDTMIG FT domain are applicable to this supplement. Additional assumptions specific to the MMSE-2 STANDARD VERSION are listed below.

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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

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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. 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 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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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 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, matching the CRF item response text, are represented inFTORRES. This result is then represented as a standard numeric score inFTSTRESN and as a standard character representation inFTSTRESC.

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4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM FT domain. It also provides guidance on how the subcategories (FTSCAT) and result variables (FTORRES, FTSTRESC, and FTSTRESN) should be populated.

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5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for Functional Tests (SUPPFT) special purpose dataset.

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