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Michigan Neuropathy Screening Instrument

(MNSI)

Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide

for Human Clinical Trials Prepared by

CDISC and Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)

Notes to Readers

This implementation guide 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 2012-03-03 0.1 Michigan Neuropathy Screening Instrument (MNSI) Draft 2012-08-07 1.0 Michigan Neuropathy Screening Instrument (MNSI)

CDISC SDTM MNSI Questionnaire Supplement (Version 1.0)

© 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved August 7, 2012

1 Introduction This document describes the CDISC implementation of the Michigan Neuropathy Screening Instrument (MNSI) questionnaire, a standard questionnaire administered on a CRF that is typically used in clinical trials to measure pain response. The MNSI CRF 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 table, which can be found at the CDISC website at http://www.cdisc.org/sdtm. These implementation details for this specific questionnaire are meant to be used in conjunction with the SDTMIG, but are recorded separately since this questionnaire may be used in many different therapeutic area implementations. All questionnaire documentation can be found on the CDISC web site (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).

1.1 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.

2 Copyright Status This instrument is in the public domain. CDISC has included the Michigan Neuropathy Screening Instrument (MNSI) as part of CDISC Data Standards. This means that 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. 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. CDISC acknowledges the MDRTC as the source of the items in the survey instruments that are included in the CDISC SDTM Pain Data Standards. Copyright information for the MNSI is: Michigan Neuropathy Screening Instrument (MNSI) (copyright University of Michigan, 2000) CDISC has developed this documentation at no cost to users of the instrument.



3 The QS Domain Model

3.1 Assumptions for Questionnaire Domain Model All assumptions for the QS domain from the SDTMIG apply for this supplemental implementation guide including those referenced in the CDISC notes. Additionally, the following assumption applies to the Michigan Neuropathy Screening Instrument (MNSI):

• Michigan Neuropathy Screening Instrument (MNSI): The Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The MNSI is designed to be used in an outpatient setting by primary care or other providers. The first part of the screening instrument consists of 15 self-administered "yes or no" questions on foot sensation including pain, numbness and temperature sensitivity. A higher score (out of a maximum of 13 points) indicates more neuropathic symptoms. The second part of the MNSI is a brief physical examination involving 1) inspection of the feet for deformities, dry skin, hair or nail abnormalities, callous or infection, 2) semi-quantitative assessment of vibration sensation at the dorsum of the great toe, 3) grading of ankle reflexes and 4) monofilament testing. Patients screening positive on the clinical portion of the MNSI (greater than 2 points on a 10 point scale) are considered neuropathic and referred for further evaluation.

• The evaluator of the questionnaire is stored in QSEVAL and for the MNSI form the Subject provides the evaluation on page 1 and the INVESTIGATOR provides the Physical Assessment evaluation on page 2.

• The MNSI CRF is to be provided at a baseline visit. QSTPT=Baseline provides that time point reference.

• Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. Additional standardization of the QSORRES, QSSTRESC and QSSTRESN fields

can be found in Section 4: Mapping Strategy.

3.2 Example for Michigan Neuropathy Screening Instrument Domain Model The MNSI example below shows the terminology for QSCAT, QSTEST, QSTESTCD and QSORRES that should be utilized for this scale. Values for QSORRES are for prospective data collection. Sponsors mapping legacy data should retain legacy values for QSORRES. A full list of value sets for QSORRES, QSSTRESC and QSSTRESN fields is provided in Section 4: Mapping strategy.



Example: Michigan Neuropathy Screening Instrument (MNSI) This example shows data from one subject collected at one visit for a MNSI questionnaire. The example uses standard CDISC controlled terminology for QSTESTCD, QSTEST and QSCAT. QSSCAT, QSORRES, QSSTRESC and QSSTRESN uses MNSI controlled terminology indicated in Section 4: Mapping Strategy. The scoring of the original results is based on the MNSI Scoring document on the Michigan Diabetes Research and Training center web site. Rows 1-37: Represent the questions from the MNSI Form for one visit for SUBJID= 2324-P0001. All original results are represented with the standard terminology in QSORRES. This result is then transformed into a standard numeric score in QSSTRESN. All summary scores can either be entered or they can be derived via the detailed questions for each summary score. When derived, QSDRVLFL is set to “Y” Rows 22, 28: Represent specify: “text” answers with no text provided in QSORRES. These records are for illustrative purposes in order to display the QSTESTCD/QSTEST values and contain the value of XXX, the actual missing record would not be created in the QS domain. Rows 16 and 37: Represent the summary scores. All summary scores can either be entered or they can be derived via the detailed questions for each summary score. When derived, QSDRVFL is set to “Y”.



QS.XPT Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN QSDRVFL

1 STUDYX QS 2324-P0001 1 MNSI101 MNSI1-Are Your Legs

and/or Feet Numb MNSI HISTORY Yes 1 1

2 STUDYX QS 2324-P0001 2 MNSI102 MNSI1-Ever Have

Burning Pain Legs/Feet MNSI HISTORY No 0 0

3 STUDYX QS 2324-P0001 3 MNSI103 MNSI1-Are Feet Too

Sensitive to Touch MNSI HISTORY No 0 0

4 STUDYX QS 2324-P0001 4 MNSI104 MNSI1-Get Muscle Cramps Legs/Feet

MNSI HISTORY No 0 0

5 STUDYX QS 2324-P0001 5 MNSI105 MNSI1-Ever Prickling

Feelings Legs/Feet MNSI HISTORY No 0 0

6 STUDYX QS 2324-P0001 6 MNSI106 MNSI1-Hurt When Bed

Covers Touch Skin MNSI HISTORY Yes 1 1

7 STUDYX QS 2324-P0001 7 MNSI107 MNSI1-Able to Tell Hot

from Cold Water MNSI HISTORY Yes 0 0

8 STUDYX QS 2324-P0001 8 MNSI108 MNSI1-Ever Had Open

Sore on Foot MNSI HISTORY Yes 1 1

9 STUDYX QS 2324-P0001 9 MNSI109 MNSI1-Doctor Says Diabetic Neuropathy

MNSI HISTORY No 0 0

10 STUDYX QS 2324-P0001 10 MNSI110 MNSI1-Feel Week All

Over Most Times MNSI HISTORY No 0 0

11 STUDYX QS 2324-P0001 11 MNSI111 MNSI1-Symptoms

Worse at Night MNSI HISTORY No 0 0

12 STUDYX QS 2324-P0001 12 MNSI112 MNSI1-Legs Hurt When

Walking MNSI HISTORY No 0 0

13 STUDYX QS 2324-P0001 13 MNSI113 MNSI1-Able to Sense Feet When Walking

MNSI HISTORY Yes 0 0

14 STUDYX QS 2324-P0001 14 MNSI114 MNSI1-Skin So Dry That

Feet Crack Open MNSI HISTORY Yes 1 1

15 STUDYX QS 2324-P0001 15 MNSI115 MNSI1-Ever Had

Amputation MNSI HISTORY Yes 1 1

16 STUDYX QS 2324-P0001 16 MNSI116 MNSI1-Total Patient

Score MNSI HISTORY 5 5 5 Y

17 STUDYX QS 2324-P0001 17 MNSI117 MNSI1-Right Foot Appears Normal

MNSI PHYSICAL ASSESSMENT

Yes 0 0

18 STUDYX QS 2324-P0001 18 MNSI118 MNSI1-Right Foot

Deformities MNSI PHYSICAL

ASSESSMENT Checked Checked

19 STUDYX QS 2324-P0001 19 MNSI119 MNSI1-Right Foot Dry

Skin, Callus MNSI PHYSICAL

ASSESSMENT Unchecked Unchecked


Infection MNSI PHYSICAL



Fissure MNSI PHYSICAL


22 STUDYX QS 2324-P0001 22 MNSI122 MNSI1-Right Foot Other

Abnormal Specify MNSI PHYSICAL

ASSESSMENT XXX

23 STUDYX QS 2324-P0001 23 MNSI123 MNSI1-Left Foot Appears Normal

MNSI PHYSICAL ASSESSMENT No 1 1



Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN QSDRVFL

24 STUDYX QS 2324-P0001 24 MNSI124 MNSI1-Left Foot

Deformities MNSI PHYSICAL


25 STUDYX QS 2324-P0001 25 MNSI125 MNSI1-Left Dry Skin,

Callus MNSI PHYSICAL



Infection MNSI PHYSICAL


27 STUDYX QS 2324-P0001 27 MNSI127 MNSI1-Left Foot Fissure MNSI PHYSICAL ASSESSMENT Unchecked Unchecked

28 STUDYX QS 2324-P0001 28 MNSI128 MNSI1-Left Foot Other

Abnormal Specify MNSI PHYSICAL

ASSESSMENT XXX


Ulceration MNSI PHYSICAL

ASSESSMENT Absent 0 0


Ulceration MNSI PHYSICAL

ASSESSMENT Present 1 1

31 STUDYX QS 2324-P0001 31 MNSI131 MNSI1-Right Ankle

Reflexes MNSI PHYSICAL

ASSESSMENT Present 0 0

32 STUDYX QS 2324-P0001 32 MNSI132 MNSI1-Left Ankle

Reflexes MNSI PHYSICAL

ASSESSMENT Present/Reinforcement

0.5 0.5

33 STUDYX QS 2324-P0001 33 MNSI133 MNSI1-Right Foot Vibration Great Toe

MNSI PHYSICAL ASSESSMENT Decreased 0.5 0.5


Vibration Great Toe MNSI PHYSICAL



Monofilament MNSI PHYSICAL

ASSESSMENT Normal 0 0


Monofilament MNSI PHYSICAL


37 STUDYX QS 2324-P0001 37 MNSI137 MNSI1-Total Clinical

Score MNSI PHYSICAL

ASSESSMENT 5 5 5 Y

Row QSEVAL VISITNUM QSETPT 1 (cont) SUBJECT 1 BASELINE 2 (cont) SUBJECT 1 BASELINE 3 (cont) SUBJECT 1 BASELINE 4 (cont) SUBJECT 1 BASELINE 5 (cont) SUBJECT 1 BASELINE 6 (cont) SUBJECT 1 BASELINE 7 (cont) SUBJECT 1 BASELINE 8 (cont) SUBJECT 1 BASELINE 9 (cont) SUBJECT 1 BASELINE 10 (cont) SUBJECT 1 BASELINE 11 (cont) SUBJECT 1 BASELINE 12 (cont) SUBJECT 1 BASELINE 13 (cont) SUBJECT 1 BASELINE 14 (cont) SUBJECT 1 BASELINE 15 (cont) SUBJECT 1 BASELINE



Row QSEVAL VISITNUM QSETPT 16 (cont) SUBJECT 1 BASELINE 17 (cont) INVESTIGATOR 1 BASELINE 18 (cont) INVESTIGATOR 1 BASELINE 19 (cont) INVESTIGATOR 1 BASELINE 20 (cont) INVESTIGATOR 1 BASELINE 21 (cont) INVESTIGATOR 1 BASELINE 22 (cont) INVESTIGATOR 1 BASELINE 23 (cont) INVESTIGATOR 1 BASELINE 24 (cont) INVESTIGATOR 1 BASELINE 25 (cont) INVESTIGATOR 1 BASELINE 26 (cont) INVESTIGATOR 1 BASELINE 27 (cont) INVESTIGATOR 1 BASELINE 28 (cont) INVESTIGATOR 1 BASELINE 29 (cont) INVESTIGATOR 1 BASELINE 30 (cont) INVESTIGATOR 1 BASELINE 31 (cont) INVESTIGATOR 1 BASELINE 32 (cont) INVESTIGATOR 1 BASELINE 33 (cont) INVESTIGATOR 1 BASELINE 34 (cont) INVESTIGATOR 1 BASELINE 35 (cont) INVESTIGATOR 1 BASELINE 36 (cont) INVESTIGATOR 1 BASELINE 37 (cont) INVESTIGATOR 1 BASELINE



4 SDTM Mapping Strategy MNSI 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, QSORRESU, QSSTRESC, QSSTRESN, and QSSTRESU) should be populated for each questionnaire. If a result variable is not included in the table for a questionnaire, it should not be populated. QSSCAT values

QSSCAT HISTORY PHYSICAL ASSESSMENT QSTESTCD= MNSI101… MNSI103 QSTEST= MNSI1-Are Your Legs and/or Feet Numb… MNSI1-Are Feet Too Sensitive to Touch

QSORRES QSSTRESC QSSTRESN Yes 1 1 No 0 0 QSTESTCD= MNSI104 QSTEST= MNSI1-Get Muscle Cramps Legs/Feet

QSORRES QSSTRESC QSSTRESN Yes 0 0 No 0 0 QSTESTCD= MNSI105… MNSI106 QSTEST= MNSI1-Ever Prickling Feelings Legs/Feet… MNSI1-Hurt When Bed Covers Touch Skin

QSORRES QSSTRESC QSSTRESN Yes 1 1 No 0 0 QSTESTCD= MNSI107 QSTEST= MNSI1-Able to Tell Hot from Cold Water

QSORRES QSSTRESC QSSTRESN Yes 0 0 No 1 1 QSTESTCD= MNSI108… MNSI109 QSTEST= MNSI1-Ever Had Open Sore on Foot… MNSI1-Doctor Says Diabetic Neuropathy

QSORRES QSSTRESC QSSTRESN Yes 1 1 No 0 0 QSTESTCD= MNSI110 QSTEST= MNSI1-Feel Week All Over Most Times



QSORRES QSSTRESC QSSTRESN Yes 0 0 No 0 0 QSTESTCD= MNSI111… MNSI112 QSTEST= MNSI1-Symptoms Worse at Night… MNSI1-Legs Hurt When Walking

QSORRES QSSTRESC QSSTRESN Yes 1 1 No 0 0 QSTESTCD= MNSI113 QSTEST= MNSI1-Able to Sense Feet When Walking

QSORRES QSSTRESC QSSTRESN Yes 0 0 No 1 1 QSTESTCD= MNSI114… MNSI115 QSTEST= MNSI1-Skin So Dry That Feet Crack Open… MNSI1-Ever Had Amputation

QSORRES QSSTRESC QSSTRESN Yes 1 1 No 0 0 QSTESTCD= MNSI117 QSTEST= MNSI1-Right Foot Appears Normal

QSORRES QSSTRESC QSSTRESN Yes 0 0 No 1 1 QSTESTCD= MNSI118… MNSI121 QSTEST= MNSI1-Right Foot Deformities… MNSI1-Right Foot Fissure

QSORRES QSSTRESC QSSTRESN Checked Checked Unchecked Unchecked QSTESTCD= MNSI123 QSTEST= MNSI1-Left Foot Appears Normal

QSORRES QSSTRESC QSSTRESN Yes 0 0 No 1 1 QSTESTCD= MNSI124… MNSI127 QSTEST= MNSI1-Left Foot Deformities… MNSI1-Left Foot Fissure

QSORRES QSSTRESC QSSTRESN Checked Checked Unchecked Unchecked QSTESTCD= MNSI129… MNSI130 QSTEST= MNSI1-Right Foot Ulceration… MNSI1-Left Foot Ulceration



QSORRES QSSTRESC QSSTRESN Absent 0 0 Present 1 1 QSTESTCD= MNSI131… MNSI132 QSTEST= MNSI1-Right Ankle Reflexes… MNSI1-Left Ankle Reflexes

QSORRES QSSTRESC QSSTRESN Present 0 0 Present/Reinforcement 0.5 0.5 Absent 1 1 QSTESTCD= MNSI133… MNSI134 QSTEST= MNSI1-Right Foot Vibration Great Toe… MNSI1-Left Foot Vibration Great Toe

QSORRES QSSTRESC QSSTRESN Present 0 0 Decreased 0.5 0.5 Absent 1 1 QSTESTCD= MNSI135… MNSI136 QSTEST= MNSI1-Right Foot Monofilament… MNSI1-Left Foot Monofilament

QSORRES QSSTRESC QSSTRESN Normal 0 0 Reduced 0.5 0.5 Absent 1 1

End of Document

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