Modified Hachinski Ischemic Scale:

NACC Version
(MHIS-NACC) v.1.0
Questionnaire Supplement to the Study Data
Tabulation Model Implementation Guide
for Human Clinical Trials
Prepared by
CAMD AD v2.0 Team and the CDISC Questionnaire Sub-team

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.

Revision History
Date
Version Summary of Changes
2013-08-29 0.1
Modified Hachinski Ischemic Scale-NACC Version
(MHIS-NACC)- Draft
2013-09-18 1.0
Modified Hachinski Ischemic Scale--NACC Version
(MHIS-NACC)

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CDISC SDTM MHIS-NACC Questionnaire Supplement (Version 1.0)

Introduction
This document describes the CDISC implementation of the Modified Hachinski Ischemic ScaleNACC Version (MHIS-NACC) questionnaire, a standard questionnaire that is typically used in
clinical trials as an assessment of functional disability used by clinicians. The information is
gathered from information obtained from history/physical/neurological exams and/or medical
records.

The MHIS-NACC questionnaire preceded the CDISC CDASH CRF standards and based on its
public domain status cannot be modified to CDASH standards.
The representation of data collected for this questionnaire is based on the Study Data Tabulation
Model Implementation Guide (SDTMIG) QS domain model, which can be found at the CDISC
website at: (http://www.cdisc.org/sdtm).
These specific implementation details for this questionnaire are meant to be used in conjunction
with the SDTMIG. All questionnaire documentation can be found on the CDISC web site at:
(http://www.cdisc.org/content2909).
The CDISC Intellectual Property Policy can be found on the CDISC web site at:
(http://www.cdisc.org/bylaws-and-policies).
Representations and Warranties, Limitations of Liability, and Disclaimers
This document is a supplement to the Study Data Tabulation Model Implementation Guide 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.

Copyright Status
This instrument is copyright approved. CDISC has included the Modified Hachinski Ischemic
Scale-NACC Version (MHIS-NACC) as part of CDISC Data Standards. Hence, CDISC developed
QSTESTCD and QSTEST for each question based on the actual question text on the questionnaire.
There may be many versions of this questionnaire in the public domain or copyright questionnaire.
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 forms annotated with the CDISC
SDTMIG submission values.
Note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should
be accessed through the CDISC website. (http://www.cdisc.org/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.
2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved

Sept 18, 2013

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CDISC SDTM MHIS-NACC Questionnaire Supplement (Version 1.0)

CDISC acknowledges John Wiley & Sons (Rosen Modification of Hachinski Ischemic Score
(Ann Neurol7:486-488, 1980). Copyright John Wiley & Sons, Inc. Reproduced by
permission.) for the agreement to include the Modified Hachinski Ischemic Scale (MHIS) in the
CDISC data standards.

(Reproduced with permission. Copyright 2011 University of Washington. Created and published
by the ADC Clinical Task Force (John C. Morris, MD, Chair) and the National Alzheimer's
Coordinating Center (Walter A. Kukull, PhD, Director). This publication was funded by the
National Institutes of Health through the National Institute on Aging (Cooperative Agreement
U01 AG016976).

3. The QS Domain Model

3.1 Assumptions for Questionnaire Domain Model
All assumptions and business rules described in the SDTMIG QS domain are applicable
to this supplement. Additional assumptions specific to the Modified Hachinski Ischemic
Scale-NACC Version (MHIS-NACC) questionnaire are listed below.
Modified Hachinski Ischemic Scale-NACC Version (MHIS-NACC) is a scale that
clinicians may use to provide an assessment of cognitive function and physical disability.
It consists of 8 items answered PRESENT or ABSENT. The information is gathered
from medical history, physical exam, neurological exams and other medical records.
1.

The total score is included as a field on this version of the CRF, therefore CDISC
controlled terminology has been created for it.

The questionnaire evaluator should be stored in QSEVAL. For MHIS-NACC, the

evaluator is usually defined as INVESTIGATOR. Additional identifying information to
further distinguish the rater in QSEVAL should be stored in QSEVALID. An example is
rater initials.
3. Terminology:
2.

a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled

terminology.
b. A full list of value sets for qualifier, timing, result and unit fields is provided
in Section 4: SDTM Mapping Strategy.

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CDISC SDTM MHIS Questionnaire Supplement (Version 1.0)

Example for the Modified Hachinski Ischemic Scale-NACC Version (MHIS-NACC)) QS Domain Model
The MHIS-NACC example below shows the terminology used to implement the questionnaire in the QS domain. This example shows
the data for one subject collected at the baseline visit for a (MHIS-NACC) questionnaire. The example uses CDISC controlled
terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES.
This result is then transformed into a standard numeric score in QSSTRESN and a character representation of the standard numeric
score in QSSTRESC.
Rows 1-8:
Row 9:

Represent the questions from the MHIS-NACC CRF.

The Total Score is recorded on the CRF.

qs.xpt
Row

STUDYID

DOMAIN

USUBJID

QSSEQ

QSTESTCD

QSTEST

QSCAT

QSORRES

QSSTRESC

STUDYX

QS

P0001

MHIS0101

MHIS01-Abrupt Onset

MHIS-NACC

PRESENT

STUDYX

QS

P0001

MHIS0102

MHIS01-Stepwise Deterioration

MHIS-NACC

PRESENT

STUDYX

QS

P0001

MHIS0103

MHIS01-Somatic Complaints

MHIS-NACC

ABSENT

STUDYX

QS

P0001

MHIS0104

MHIS01-Emotional Incontinence

MHIS-NACC

PRESENT

STUDYX

QS

P0001

MHIS0105

MHIS01-History/Presence of Hypertension

MHIS-NACC

PRESENT

STUDYX

QS

P0001

MHIS0106

MHIS01-History of Stroke

MHIS-NACC

PRESENT

STUDYX

QS

P0001

MHIS0107

MHIS01-Focal Neurological Symptoms

MHIS-NACC

ABSENT

STUDYX

QS

P0001

MHIS0108

MHIS01-Focal Neurological Signs

MHIS-NACC

ABSENT

STUDYX

QS

P0001

MHIS0109

MHIS01-Total Score

MHIS-NACC

qs.xpt cont.
Row

QSSTRESN

QSBLFL

QSEVAL

QSEVALID

VISITNUM

QSDTC

1 (cont)

INVESTIGATOR

BS

2012-11-16

2 (cont)

INVESTIGATOR

BS

2012-11-16

3 (cont)

INVESTIGATOR

BS

2012-11-16

4 (cont)

INVESTIGATOR

BS

2012-11-16

5 (cont)

INVESTIGATOR

BS

2012-11-16

6 (cont)

INVESTIGATOR

BS

2012-11-16

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CDISC SDTM MHIS-NACC Questionnaire Supplement (Version 1.0)

Row

QSSTRESN

QSBLFL

QSEVAL

QSEVALID

VISITNUM

QSDTC

7 (cont)

INVESTIGATOR

BS

2012-11-16

8 (cont)

INVESTIGATOR

BS

2012-11-16

9 (cont)

INVESTIGATOR

BS

2012-11-16

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CDISC SDTM MHIS-NACC Questionnaire Supplement (Version 1.0)

Section 4: SDTM Mapping Strategy

MHIS-NACC specific mapping strategy: This section is used for reference with the annotated CRF for further details on the CRF data
capture and to understand the alignment of the questionnaire to the SDTM QS domain. It also provides guidance on how the result
variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated for the questionnaire. For all questions, the following scale
should be used.

QSTESTCD=MHIS0102
QSTESTCD=MHIS0103
QSTESTCD=MHIS0104
QSTESTCD=MHIS0105

QSTEST = MHIS01-Stepwise Deterioration

QSTEST = MHIS01-Somatic Complaints
QSTEST = MHIS01-Emotional Incontinence
QSTEST = MHIS01-History/Presence of Hypertension

QSORRES QSSTRESC QSSTRESN

PRESENT
1
1
ABSENT
0
0

QSTESTCD=MHIS0101
QSTESTCD=MHIS0106
QSTESTCD=MHIS0107
QSTESTCD=MHIS0108

QSTEST = MHIS01-Abrupt Onset

QSTEST = MHIS01-History of Stroke
QSTEST = MHIS01-Focal Neurological Symptoms
QSTEST = MHIS01-Focal Neurological Signs

QSORRES QSSTRESC QSSTRESN

PRESENT
2
2
ABSENT
0
0

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CDISC SDTM MHIS-NACC Questionnaire Supplement (Version 1.0)

End of Document

2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved

Sept 18, 2013

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