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Information for Reviewers

Text in black is part of the template used to create this document and is not revised under CDISC internal or public review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Mini-Mental State Examination (MMSE)

CDISC ReferenceFunctional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

MMSE

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2023-08-24
Notes to ReadersThis 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.



Revision History

DateVersion
2023-08-241.0 Draft

© 2023 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 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.

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.

The CDISC Intellectual Property Policy can be found on the CDISC website 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 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 instrument and has granted CDISC permission to include this supplement in the CDISC inventory QRSSUPP-621 - Getting issue details... STATUS 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.

Copyright© 1975, 1998, 2001 by MinMental 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

QRSSUPP-623 - Getting issue details... STATUS

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.

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

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 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. QRSSUPP-622 - Getting issue details... STATUS
  • 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

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 0 for incorrect answers. The sum of the 30 tasks is captured as a total score (0-30). QRSSUPP-624 - Getting issue details... STATUS 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. QRSSUPP-625 - Getting issue details... STATUS QRSSUPP-628 - Getting issue details... STATUS QRSSUPP-626 - Getting issue details... STATUS

     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 subscore for either one of the two sets of questions used is represented by 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. 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 score generation processes, records are not included for derived subscores or total scores that are not provided.
  5. The MMSE instrument includes subscore QRSSUPP-629 - Getting issue details... STATUS and total scores 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. QRSSUPP-630 - Getting issue details... STATUS

    1. Subscore and total scores are represented in--ORRES, --STRESC, and --STRESN. QRSSUPP-631 - Getting issue details... STATUS
    2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM. QRSSUPP-632 - Getting issue details... STATUS It is the sponsors repsonsibility to do this verification based on the instrument's user 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.

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 3 subjects collected at the baseline visit for the MMSE instrument. The example uses CDISC controlled terminology for FTTESTCD, FTTEST, and FTCAT.  All original results, matching the CRF item response text, are represented in FTORRES. This result is then represented as a standard numeric score in FTSTRESN and as a standard character representation in FTSTRESC.

The table represents the items, subscore, 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.

ft.xpt

ft.xpt

RowSTUDYIDDOMAINUSUBJIDFTSEQFTTESTCDFTTESTFTCATFTSCATFTORRESFTSTRESCFTSTRESNFTSTATFTREASNDFTLOBXFLVISITNUMFTDTC
1STUDYXFT2324-P00011MMS101AMMS1-What Is the YearMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
2STUDYXFT2324-P00012MMS101BMMS1-What Is the SeasonMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
3STUDYXFT2324-P00013MMS101CMMS1-What Is the Month of YearMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
4STUDYXFT2324-P00014MMS101DMMS1-What Is the Day of WeekMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
5STUDYXFT2324-P00015MMS101EMMS1-What Is the DateMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
6STUDYXFT2324-P00016MMS102AMMS1-What Is the StateMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
7STUDYXFT2324-P00017MMS102BMMS1-What Is the CountyMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
8STUDYXFT2324-P00018MMS102CMMS1-What Is the City/TownMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
9STUDYXFT2324-P00019MMS102DMMS1-What Is the BuildingMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
10STUDYXFT2324-P000110MMS102EMMS1-What Is the FloorMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
11STUDYXFT2324-P000111MMS103AMMS1-Repeat Word 1MMSEREGISTRATIONCORRECT11

Y12015-05-15
12STUDYXFT2324-P000112MMS103BMMS1-Repeat Word 2MMSEREGISTRATIONCORRECT11

Y12015-05-15
13STUDYXFT2324-P000113MMS103CMMS1-Repeat Word 3MMSEREGISTRATIONCORRECT11

Y12015-05-15
14STUDYXFT2324-P000114MMS104AAMMS1-What is 100 Take Away 7MMSEATTENTION AND CALCULATIONCORRECT11

Y12015-05-15
15STUDYXFT2324-P000115MMS104ABMMS1-Keep Subtracting 7 Step 2 QRSSUPP-633 - Jira project doesn't exist or you don't have permission to view it. MMSEATTENTION AND CALCULATIONCORRECT11

Y12015-05-15
16STUDYXFT2324-P000116MMS104ACMMS1-Keep Subtracting 7 Step 3MMSEATTENTION AND CALCULATIONCORRECT11

Y12015-05-15
17STUDYXFT2324-P000117MMS104ADMMS1-Keep Subtracting 7 Step 4MMSEATTENTION AND CALCULATIONINCORRECT00

Y12015-05-15
18STUDYXFT2324-P000118MMS104AEMMS1-Keep Subtracting 7 Step 5MMSEATTENTION AND CALCULATIONINCORRECT00

Y12015-05-15
19STUDYXFT2324-P000119MMS104BAMMS1-Spell Backward Letter 1MMSEATTENTION AND CALCULATION


NOT DONESUBJECT REFUSED TO ANSWERY12015-05-15
20STUDYXFT2324-P000120MMS104BBMMS1-Spell Backward Letter 2MMSEATTENTION AND CALCULATION


NOT DONESUBJECT REFUSED TO ANSWERY12015-05-15
21STUDYXFT2324-P000121MMS104BCMMS1-Spell Backward Letter 3MMSEATTENTION AND CALCULATION


NOT DONESUBJECT REFUSED TO ANSWERY12015-05-15
22STUDYXFT2324-P000122MMS104BDMMS1-Spell Backward Letter 4MMSEATTENTION AND CALCULATION


NOT DONESUBJECT REFUSED TO ANSWERY12015-05-15
23STUDYXFT2324-P000123MMS104BEMMS1-Spell Backward Letter 5MMSEATTENTION AND CALCULATION


NOT DONESUBJECT REFUSED TO ANSWERY12015-05-15
24STUDYXFT2324-P000124MMS104 QRSSUPP-634 - Jira project doesn't exist or you don't have permission to view it. MMS1-Attention and Calculation SubtotalMMSEATTENTION AND CALCULATION333

Y12015-05-15
25STUDYXFT2324-P000125MMS105AMMS1-Recall Word 1MMSERECALLCORRECT11

Y12015-05-15
26STUDYXFT2324-P000126MMS105BMMS1-Recall Word 2MMSERECALLCORRECT11

Y12015-05-15
27STUDYXFT2324-P000127MMS105CMMS1-Recall Word 3MMSERECALLCORRECT11

Y12015-05-15
28STUDYXFT2324-P000128MMS106AMMS1-Naming Object 1MMSENAMINGCORRECT11

Y12015-05-15
29STUDYXFT2324-P000129MMS106BMMS1-Naming Object 2MMSENAMINGINCORRECT00

Y12015-05-15
30STUDYXFT2324-P000130MMS107MMS1-Repeat What I SayMMSEREPETITIONCORRECT11

Y12015-05-15
31STUDYXFT2324-P000131MMS108AMMS1-Take in Right HandMMSECOMPREHENSIONCORRECT11

Y12015-05-15
32STUDYXFT2324-P000132MMS108BMMS1-Fold in HalfMMSECOMPREHENSIONCORRECT11

Y12015-05-15
33STUDYXFT2324-P000133MMS108CMMS1-Put on Floor (or Table)MMSECOMPREHENSIONCORRECT11

Y12015-05-15
34STUDYXFT2324-P000134MMS109MMS1-Read This and Do What It SaysMMSEREADINGINCORRECT00

Y12015-05-15
35STUDYXFT2324-P000135MMS110MMS1-Write a SentenceMMSEWRITINGCORRECT11

Y12015-05-15
36STUDYXFT2324-P000136MMS111MMS1-Copy This DesignMMSEDRAWINGINCORRECT00

Y12015-05-15
37STUDYXFT2324-P000137MMS112MMS1-Total ScoreMMSE
252525

Y12015-05-15
38STUDYXFT2324-P000138MMS113MMS1-Level of ConsciousnessMMSE
Alert/ResponsiveAlert/Responsive.

Y12015-05-15
39STUDYXFT2324-P00021MMS101AMMS1-What Is the YearMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
40STUDYXFT2324-P00022MMS101BMMS1-What Is the SeasonMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
41STUDYXFT2324-P00023MMS101CMMS1-What Is the Month of YearMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
42STUDYXFT2324-P00024MMS101CMMS1-What Is the Month of YearMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
43STUDYXFT2324-P00025MMS101DMMS1-What Is the Day of WeekMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
44STUDYXFT2324-P00026MMS101EMMS1-What Is the DateMMSEORIENTATION TO TIMECORRECT11

Y12015-05-15
45STUDYXFT2324-P00027MMS102AMMS1-What Is the StateMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
46STUDYXFT2324-P00028MMS102BMMS1-What Is the CountyMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
47STUDYXFT2324-P00029MMS102CMMS1-What Is the City/TownMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
48STUDYXFT2324-P000210MMS102DMMS1-What Is the BuildingMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
49STUDYXFT2324-P000211MMS102EMMS1-What Is the FloorMMSEORIENTATION TO PLACECORRECT11

Y12015-05-15
50STUDYXFT2324-P000212MMS103AMMS1-Repeat Word 1MMSEREGISTRATIONCORRECT11

Y12015-05-15
51STUDYXFT2324-P000213MMS103BMMS1-Repeat Word 2MMSEREGISTRATIONCORRECT11

Y12015-05-15
52STUDYXFT2324-P000214MMS103CMMS1-Repeat Word 3MMSEREGISTRATIONCORRECT11

Y12015-05-15
53STUDYXFT2324-P000215MMS104AAMMS1-What is 100 Take Away 7MMSEATTENTION AND CALCULATION


NOT DONE

SUBJECT REFUSED TO ANSWER QRSSUPP-635 - Jira project doesn't exist or you don't have permission to view it.

Y12015-05-15
54STUDYXFT2324-P000216MMS104ABMMS1-Keep Subtracting 7 Step 2MMSEATTENTION AND CALCULATION


NOT DONESUBJECT REFUSED TO ANSWERY12015-05-15
55STUDYXFT2324-P000217MMS104ACMMS1-Keep Subtracting 7 Step 3MMSEATTENTION AND CALCULATION


NOT DONESUBJECT REFUSED TO ANSWERY12015-05-15
56STUDYXFT2324-P000218MMS104ADMMS1-Keep Subtracting 7 Step 4MMSEATTENTION AND CALCULATION


NOT DONESUBJECT REFUSED TO ANSWERY12015-05-15
57STUDYXFT2324-P000219MMS104AEMMS1-Keep Subtracting 7 Step 5MMSEATTENTION AND CALCULATION


NOT DONESUBJECT REFUSED TO ANSWERY12015-05-15
58STUDYXFT2324-P000220MMS104BAMMS1-Spell Backward  Letter 1MMSEATTENTION AND CALCULATIONCORRECT11

Y12015-05-15
59STUDYXFT2324-P000221MMS104BBMMS1-Spell Backward Letter 2MMSEATTENTION AND CALCULATIONCORRECT11

Y12015-05-15
60STUDYXFT2324-P000222MMS104BCMMS1-Spell Backward Letter 3MMSEATTENTION AND CALCULATIONINCORRECT00

Y12015-05-15
61STUDYXFT2324-P000223MMS104BDMMS1-Spell Backward Letter 4MMSEATTENTION AND CALCULATIONINCORRECT00

Y12015-05-15
62STUDYXFT2324-P000224MMS104BEMMS1-Spell Backward Letter 5MMSEATTENTION AND CALCULATIONCORRECT11

Y12015-05-15
63STUDYXFT2324-P000225MMS104MMS1-Attention and Calculation SubtotalMMSEATTENTION AND CALCULATION333

Y

QRSSUPP-636 - Jira project doesn't exist or you don't have permission to view it.

2015-05-15
64STUDYXFT2324-P000226MMS105AMMS1-Recall Word 1MMSERECALLCORRECT11

Y12015-05-15
65STUDYXFT2324-P000227MMS105BMMS1-Recall Word 2MMSERECALLCORRECT11

Y12015-05-15
66STUDYXFT2324-P000228MMS105CMMS1-Recall Word 3MMSERECALLCORRECT11

Y12015-05-15
67STUDYXFT2324-P000229MMS106AMMS1-Naming Object 1MMSENAMINGCORRECT11

Y12015-05-15
68STUDYXFT2324-P000230MMS106BMMS1-Naming Object 2MMSENAMINGINCORRECT00

Y12015-05-15
69STUDYXFT2324-P000231MMS107MMS1-Repeat What I SayMMSEREPETITIONCORRECT11

Y12015-05-15
70STUDYXFT2324-P000232MMS108AMMS1-Take in Right HandMMSECOMPREHENSIONCORRECT11

Y12015-05-15
71STUDYXFT2324-P000233MMS108BMMS1-Fold in HalfMMSECOMPREHENSIONCORRECT11

Y12015-05-15
72STUDYXFT2324-P000234MMS108CMMS1-Put on Floor (or Table)MMSECOMPREHENSIONCORRECT11

Y12015-05-15
73STUDYXFT2324-P000235MMS109MMS1-Read This and Do What It SaysMMSEREADINGINCORRECT00

Y12015-05-15
74STUDYXFT2324-P000236MMS110MMS1-Write a SentenceMMSEWRITINGCORRECT11

Y12015-05-15
75STUDYXFT2324-P000237MMS111MMS1-Copy This DesignMMSEDRAWINGINCORRECT00

Y12015-05-15
76STUDYXFT2324-P000238MMS112MMS1-Total ScoreMMSE
262626

Y12015-05-15
77STUDYXFT2324-P000239MMS113MMS1-Level of ConsciousnessMMSE
DrowsyDrowsy.

Y12015-05-15
78STUDYXFT2324-P00031MMS101AMMS1-What Is the YearMMSEORIENTATION TO TIME


NOT DONE

12015-05-15
79STUDYXFT2324-P00032MMS101BMMS1-What Is the SeasonMMSEORIENTATION TO TIME


NOT DONE

12015-05-15
80STUDYXFT2324-P00033MMS101CMMS1-What Is the Month of YearMMSEORIENTATION TO TIME


NOT DONE

12015-05-15
81STUDYXFT2324-P00034MMS101DMMS1-What Is the Day of WeekMMSEORIENTATION TO TIME


NOT DONE

12015-05-15
82STUDYXFT2324-P00035MMS101EMMS1-What Is the DateMMSEORIENTATION TO TIME


NOT DONE

12015-05-15
83STUDYXFT2324-P00036MMS102AMMS1-What Is the StateMMSEORIENTATION TO PLACE


NOT DONE

12015-05-15
84STUDYXFT2324-P00037MMS102BMMS1-What Is the CountyMMSEORIENTATION TO PLACE


NOT DONE

12015-05-15
85STUDYXFT2324-P00038MMS102CMMS1-What Is the City/TownMMSEORIENTATION TO PLACE


NOT DONE

12015-05-15
86STUDYXFT2324-P00039MMS102DMMS1-What Is the BuildingMMSEORIENTATION TO PLACE


NOT DONE

12015-05-15
87STUDYXFT2324-P000310MMS102EMMS1-What Is the FloorMMSEORIENTATION TO PLACE


NOT DONE

12015-05-15
88STUDYXFT2324-P000311MMS103AMMS1-Repeat Word 1MMSEREGISTRATION


NOT DONE

12015-05-15
89STUDYXFT2324-P000312MMS103BMMS1-Repeat Word 2MMSEREGISTRATION


NOT DONE

12015-05-15
90STUDYXFT2324-P000313MMS103CMMS1-Repeat Word 3MMSEREGISTRATION


NOT DONE

12015-05-15
91STUDYXFT2324-P000314MMS104AAMMS1-What is 100 Take Away 7MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
92STUDYXFT2324-P000315MMS104ABMMS1-Keep Subtracting 7 Step 2MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
93STUDYXFT2324-P000316MMS104ACMMS1-Keep Subtracting 7 Step 3MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
94STUDYXFT2324-P000317MMS104ADMMS1-Keep Subtracting 7 Step 4MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
95STUDYXFT2324-P000318MMS104AEMMS1-Keep Subtracting 7 Step 5MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
96STUDYXFT2324-P000319MMS104BAMMS1-Spell Backward Letter 1MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
97STUDYXFT2324-P000320MMS104BBMMS1-Spell Backward Letter 2MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
98STUDYXFT2324-P000321MMS104BCMMS1-Spell Backward Letter 3MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
99STUDYXFT2324-P000322MMS104BDMMS1-Spell Backward Letter 4MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
100STUDYXFT2324-P000323MMS104BEMMS1-Spell Backward Letter 5MMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
101STUDYXFT2324-P000324MMS104MMS1-Attention and Calculation SubtotalMMSEATTENTION AND CALCULATION


NOT DONE

12015-05-15
102STUDYXFT2324-P000325MMS105AMMS1-Recall Word 1MMSERECALL


NOT DONE

12015-05-15
103STUDYXFT2324-P000326MMS105BMMS1-Recall Word 2MMSERECALL


NOT DONE

12015-05-15
104STUDYXFT2324-P000327MMS105CMMS1-Recall Word 3MMSERECALL


NOT DONE

12015-05-15
105STUDYXFT2324-P000328MMS106AMMS1-Naming Object 1MMSENAMING


NOT DONE

12015-05-15
106STUDYXFT2324-P000329MMS106BMMS1-Naming Object 2MMSENAMING


NOT DONE

12015-05-15
107STUDYXFT2324-P000330MMS107MMS1-Repeat What I SayMMSEREPETITION


NOT DONE

12015-05-15
108STUDYXFT2324-P000331MMS108AMMS1-Take in Right HandMMSECOMPREHENSION


NOT DONE

12015-05-15
109STUDYXFT2324-P000332MMS108BMMS1-Fold in HalfMMSECOMPREHENSION


NOT DONE

12015-05-15
110STUDYXFT2324-P000333MMS108CMMS1-Put on Floor (or Table)MMSECOMPREHENSION


NOT DONE

12015-05-15
111STUDYXFT2324-P000334MMS109MMS1-Read This and Do What It SaysMMSEREADING


NOT DONE

12015-05-15
112STUDYXFT2324-P000335MMS110MMS1-Write a SentenceMMSEWRITING


NOT DONE

12015-05-15
113STUDYXFT2324-P000336MMS111MMS1-Copy This DesignMMSEDRAWING


NOT DONE

12015-05-15
114STUDYXFT2324-P000337MMS112MMS1-Total ScoreMMSE



NOT DONE

12015-05-15
115STUDYXFT2324-P000338MMS113MMS1-Level of ConsciousnessMMSE



NOT DONE

12015-05-15

Dataset Debug Messages

  • When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.
  • There is a leading, trailing, or non-breaking space in the dataset.

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

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suppft.xpt

STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
STUDYXFT2324-P0003FTCATMMSEFTPPRAIDPreprinted Administrator IdentifierEXAMINERCRF
STUDYXFT2324-P0003FTCATMMSEFTCOLAIDCollected Administrator IdentifierADM1CRF
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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 the result variables (FTORRES, FTSTRESC, and FTSTRESN) should be populated.

FTSCATFTTESTCD
ORIENTATION TO TIME
MMS101A-MMS101E
ORIENTATION TO PLACE
MMS102A-MMS102E
REGISTRATIONMMS103A-MMS103C
ATTENTION AND CALCULATIONMMS104AA-MMS104AE, MMS104BA-MMS104BE, MMS104
RECALLMMS105A-MMS105C
NAMINGMMS106A-MMS106B
REPETITIONMMS107
COMPREHENSIONMMS108A-MMS108C
READINGMMS109
WRITINGMMS110
DRAWINGMMS111


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"

FTORRESFTSTRESCFTSTRESN
INCORRECT
00
CORRECT
11


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

FTORRESFTSTRESC
Alert/Responsive
Alert/Responsive
Drowsy
Drowsy
Stuporous
Stuporous
Comatose/UnresponsiveComatose/Unresponsive


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.

QNAMQLABELQVAL
FTPPRAIDPreprinted Administrator IdentifierEXAMINER
FTCOLAIDCollected Administrator IdentifierADM1

End of Document


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