Modified Hachinski Ischemic Scale: NACC Version (MHIS-NACC) v.1.0

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) 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1

Introduction This document describes the CDISC implementation of the Modified Hachinski Ischemic Scale- NACC 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 Page 2

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. 2. 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: 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. 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3

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: Represent the questions from the MHIS-NACC CRF. Row 9: The Total Score is recorded on the CRF. qs.xpt Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC 1 STUDYX QS P0001 1 MHIS0101 MHIS01-Abrupt Onset MHIS-NACC PRESENT 2 2 STUDYX QS P0001 2 MHIS0102 MHIS01-Stepwise Deterioration MHIS-NACC PRESENT 1 3 STUDYX QS P0001 3 MHIS0103 MHIS01-Somatic Complaints MHIS-NACC ABSENT 0 4 STUDYX QS P0001 4 MHIS0104 MHIS01-Emotional Incontinence MHIS-NACC PRESENT 1 5 STUDYX QS P0001 5 MHIS0105 MHIS01-History/Presence of Hypertension MHIS-NACC PRESENT 1 6 STUDYX QS P0001 6 MHIS0106 MHIS01-History of Stroke MHIS-NACC PRESENT 2 7 STUDYX QS P0001 7 MHIS0107 MHIS01-Focal Neurological Symptoms MHIS-NACC ABSENT 0 8 STUDYX QS P0001 8 MHIS0108 MHIS01-Focal Neurological Signs MHIS-NACC ABSENT 0 9 STUDYX QS P0001 9 MHIS0109 MHIS01-Total Score MHIS-NACC 7 7 qs.xpt cont. Row QSSTRESN QSBLFL QSEVAL QSEVALID VISITNUM QSDTC 1 (cont) 2 Y INVESTIGATOR BS 1 2012-11-16 2 (cont) 1 Y INVESTIGATOR BS 1 2012-11-16 3 (cont) 0 Y INVESTIGATOR BS 1 2012-11-16 4 (cont) 1 Y INVESTIGATOR BS 1 2012-11-16 5 (cont) 1 Y INVESTIGATOR BS 1 2012-11-16 6 (cont) 3 Y INVESTIGATOR BS 1 2012-11-16 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

Row QSSTRESN QSBLFL QSEVAL QSEVALID VISITNUM QSDTC 7 (cont) 0 Y INVESTIGATOR BS 1 2012-11-16 8 (cont) 0 Y INVESTIGATOR BS 1 2012-11-16 9 (cont) 7 Y INVESTIGATOR BS 1 2012-11-16 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

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 QSTEST = MHIS01-Stepwise Deterioration QSTESTCD=MHIS0103 QSTEST = MHIS01-Somatic Complaints QSTESTCD=MHIS0104 QSTEST = MHIS01-Emotional Incontinence QSTESTCD=MHIS0105 QSTEST = MHIS01-History/Presence of Hypertension QSORRES QSSTRESC QSSTRESN PRESENT 1 1 ABSENT 0 0 QSTESTCD=MHIS0101 QSTEST = MHIS01-Abrupt Onset QSTESTCD=MHIS0106 QSTEST = MHIS01-History of Stroke QSTESTCD=MHIS0107 QSTEST = MHIS01-Focal Neurological Symptoms QSTESTCD=MHIS0108 QSTEST = MHIS01-Focal Neurological Signs QSORRES QSSTRESC QSSTRESN PRESENT 2 2 ABSENT 0 0 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6

End of Document 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7