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© 2021 2023 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.

CDISC does did not modify this QRS instruments 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.

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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.

CDISC specifies how to structure the data that 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.

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. PARCDISC 

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 variables with submission values. 

Note: CDISC controlled terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC  website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder.

CDISC acknowledges R. Bob Smith III, PhD, Chairman and CEO Psychological Assessment Resources, Inc. for the approval to implement the MMSE-2 STANDARD VERSION as CDISC data standard.

Reference for the MMSE-2 STANDARD VERSION:

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.

Copyright© 2010 by Mini Mental LLC, Inc. All rights reserved. Published 2010 by Psychological Assessment Resources, Inc. May not be reproduced in whole or in part in any form or by any means without written permission of Psychological Assessment Resources, Inc.

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.

Copyright© 2010 by Mini Mental LLC, Inc. All rights reserved. Published 2010 by Psychological Assessment Resources, Inc. May not be reproduced in whole or in part in any form or by any means without written permission of Psychological Assessment Resources, Inc.

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.

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 variables with submission values. 

Note: CDISC controlled terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC  website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder.

CDISC acknowledges R. Bob Smith III, PhD, Chairman and CEO Psychological Assessment Resources, Inc., for the approval to implement the MMSE-2 STANDARD VERSION as CDISC data standard.

Reference for the MMSE-2 STANDARD VERSION:

• 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 conline refernce to the MMSE-2 STANDARD VERSION: https://www.parinc.com/Products/Pkey/238

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.

MMSE-2 STANDARD VERSION is widely used to assess cognitive impairment and its progression over time. It includes It includes 30 tasks that are scored as a 1 for correct answers and 0 for incorrect answers. There is a a  brief version total raw score (0-16) at the bottom

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 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.

   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].

   2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
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 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 questions from the MMSE-2 STANDARD VERSION instrument. Rows 31 and 32 show the brief and standard total raw scores for USUBJID = "2324-P0001". USUBJID="2324-P0002" did not perform the MMSE-2 STANDARD VERSION.

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 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 = "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 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. Subscore and overall 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 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.

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.

The table represents the questions from the MMSE-2 STANDARD VERSION instrument. Rows 31 and 32 show the brief and standard total raw scores for USUBJID = "2324-P0001". USUBJID="2324-P0002" did not perform the MMSE-2 STANDARD VERSION at the scheduled visit.

The preprinted and collected administrator information is represented in the SUPPFT domain.