Revision History

© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Mini-Mental State Examination (MMSE) instrument.

 CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this functional test 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 specific implementation details for this functional test 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/foundational/qrs).

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 has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

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 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 QSTESTCD and QSTEST for each item based on the actual text on the functional test. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

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 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 (https://www.cdisc.org/standards/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 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.

Copyright© 1975, 1998, 2001 by Mini Mental LLC, Inc. All rights reserved. Published 2001 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, by Marshal Folstein, MD and Susan Folstein, MD, Copyright 1975, 1998, 2001 by Mini Mental LLC, Inc. Published 2001 by Psychological Assessment Resources, Inc. Further reproduction is prohibited without permission of PAR, Inc. The MMSE 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 are listed below.

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

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 serial 7s and WORLD questions, the numeric rating is "0-5", and the sub-score for these questions is represented where 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. The MMSE instrument includes a total score that is considered as captured data on the CRF and is not considered as derived in the example below.

   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 written on a CRF 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 Section 4, 4.1.8.1, Origin Metadata for Variables].

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 FT Domain Model

The MMSE example below shows the terminology used to implement the instrument in the FT domain. This example shows the data for two subjects collected at the baseline visit for a MMSE 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, subtotal and total scores from the MMSE form. 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.

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 the result variables (FTORRES, FTSTRESC and FTSTRESN) should be populated.

FTTESTCD = "MMS101A" FTTEST = "MMS1-What Is the Year"... FTTESTCD = "MMS103C" FTTEST = "MMS1-Repeat Word 3"

FTTESTCD = "MMS104AA" FTTEST = "MMS1-What is 100 Take Away 7" ... FTTESTCD = "MMS111" FTTEST = "MMS1-Copy This Design"

FTTESTCD = "MMS113"  FTTEST = "MMS1-Level of Consciousness"

End of Document