Michigan Neuropathy Screening Instrument () 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 () Draft 2012-08-07 1.0 Michigan Neuropathy Screening Instrument ()
CDISC SDTM Questionnaire Supplement (Version 1.0) 1 Introduction This document describes the CDISC implementation of the Michigan Neuropathy Screening Instrument () questionnaire, a standard questionnaire administered on a CRF that is typically used in clinical trials to measure pain response. The 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 () 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 is: Michigan Neuropathy Screening Instrument () (copyright University of Michigan, 2000) CDISC has developed this documentation at no cost to users of the instrument. 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2
CDISC SDTM Questionnaire Supplement (Version 1.0) 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 (): Michigan Neuropathy Screening Instrument (): The Michigan Neuropathy Screening Instrument () is designed to screen for the presence of diabetic neuropathy. The 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 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 (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 form the Subject provides the evaluation on page 1 and the INVESTIGATOR provides the Physical Assessment evaluation on page 2. The 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 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. 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3
CDISC SDTM Questionnaire Supplement (Version 1.0) Example: Michigan Neuropathy Screening Instrument () This example shows data from one subject collected at one visit for a questionnaire. The example uses standard CDISC controlled terminology for QSTESTCD, QSTEST and QSCAT. QSSCAT, QSORRES, QSSTRESC and QSSTRESN uses controlled terminology indicated in Section 4: Mapping Strategy. The scoring of the original results is based on the Scoring document on the Michigan Diabetes Research and Training center web site. Rows 1-37: Represent the questions from the 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. 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4
CDISC SDTM Questionnaire Supplement (Version 1.0) QS.XPT Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSDRVFL 1 STUDYX QS 2324-P0001 1 101 1-Are Your Legs and/or Feet Numb HISTORY Yes 1 1 2 STUDYX QS 2324-P0001 2 102 1-Ever Have Burning Pain Legs/Feet HISTORY 3 STUDYX QS 2324-P0001 3 103 1-Are Feet Too Sensitive to Touch HISTORY 4 STUDYX QS 2324-P0001 4 104 1-Get Muscle Cramps Legs/Feet HISTORY 5 STUDYX QS 2324-P0001 5 105 1-Ever Prickling Feelings Legs/Feet HISTORY 6 STUDYX QS 2324-P0001 6 106 1-Hurt When Bed Covers Touch Skin HISTORY Yes 1 1 7 STUDYX QS 2324-P0001 7 107 1-Able to Tell Hot from Cold Water HISTORY 8 STUDYX QS 2324-P0001 8 108 1-Ever Had Open Sore on Foot HISTORY Yes 1 1 9 STUDYX QS 2324-P0001 9 109 1-Doctor Says Diabetic Neuropathy HISTORY 10 STUDYX QS 2324-P0001 10 110 1-Feel Week All Over Most Times HISTORY 11 STUDYX QS 2324-P0001 11 111 1-Symptoms Worse at Night HISTORY 12 STUDYX QS 2324-P0001 12 112 1-Legs Hurt When Walking HISTORY 13 STUDYX QS 2324-P0001 13 113 1-Able to Sense Feet When Walking HISTORY 14 STUDYX QS 2324-P0001 14 114 1-Skin So Dry That Feet Crack Open HISTORY Yes 1 1 15 STUDYX QS 2324-P0001 15 115 1-Ever Had Amputation HISTORY Yes 1 1 16 STUDYX QS 2324-P0001 16 116 1-Total Patient Score HISTORY 5 5 5 Y 17 STUDYX QS 2324-P0001 17 117 1-Right Foot Appears Normal 18 STUDYX QS 2324-P0001 18 118 1-Right Foot Deformities Checked Checked 19 STUDYX QS 2324-P0001 19 119 1-Right Foot Dry Skin, Callus Unchecked Unchecked 20 STUDYX QS 2324-P0001 20 120 1-Right Foot Infection Checked Checked 21 STUDYX QS 2324-P0001 21 121 1-Right Foot Fissure Unchecked Unchecked 22 STUDYX QS 2324-P0001 22 122 1-Right Foot Other Abnormal Specify XXX 23 STUDYX QS 2324-P0001 23 123 1-Left Foot Appears Normal No 1 1 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5
CDISC SDTM Questionnaire Supplement (Version 1.0) Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSDRVFL 24 STUDYX QS 2324-P0001 24 124 1-Left Foot Deformities Checked Checked 25 STUDYX QS 2324-P0001 25 125 1-Left Dry Skin, Callus Unchecked Unchecked 26 STUDYX QS 2324-P0001 26 126 1-Left Foot Infection Checked Checked 27 STUDYX QS 2324-P0001 27 127 1-Left Foot Fissure Unchecked Unchecked 28 STUDYX QS 2324-P0001 28 128 1-Left Foot Other Abnormal Specify XXX 29 STUDYX QS 2324-P0001 29 129 1-Right Foot Ulceration Absent 0 0 30 STUDYX QS 2324-P0001 30 130 1-Left Foot Ulceration Present 1 1 31 STUDYX QS 2324-P0001 31 131 1-Right Ankle Reflexes Present 0 0 32 STUDYX QS 2324-P0001 32 132 1-Left Ankle Present/Rei Reflexes nforcement 0.5 0.5 33 STUDYX QS 2324-P0001 33 133 1-Right Foot Vibration Great Toe Decreased 0.5 0.5 34 STUDYX QS 2324-P0001 34 134 1-Left Foot Vibration Great Toe Absent 1 1 35 STUDYX QS 2324-P0001 35 135 1-Right Foot Monofilament Normal 0 0 36 STUDYX QS 2324-P0001 36 136 1-Left Foot Monofilament Absent 1 1 37 STUDYX QS 2324-P0001 37 137 1-Total Clinical Score 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 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6
CDISC SDTM Questionnaire Supplement (Version 1.0) 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 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7
CDISC SDTM Questionnaire Supplement (Version 1.0) 4 SDTM Mapping Strategy 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 QSTESTCD= 101 103 QSTEST= 1-Are Your Legs and/or Feet Numb 1-Are Feet Too Sensitive to Touch Yes 1 1 QSTESTCD= 104 QSTEST= 1-Get Muscle Cramps Legs/Feet QSTESTCD= 105 106 QSTEST= 1-Ever Prickling Feelings Legs/Feet 1-Hurt When Bed Covers Touch Skin Yes 1 1 QSTESTCD= 107 QSTEST= 1-Able to Tell Hot from Cold Water No 1 1 QSTESTCD= 108 109 QSTEST= 1-Ever Had Open Sore on Foot 1-Doctor Says Diabetic Neuropathy Yes 1 1 QSTESTCD= 110 QSTEST= 1-Feel Week All Over Most Times 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8
CDISC SDTM Questionnaire Supplement (Version 1.0) QSTESTCD= 111 112 QSTEST= 1-Symptoms Worse at Night 1-Legs Hurt When Walking Yes 1 1 QSTESTCD= 113 QSTEST= 1-Able to Sense Feet When Walking No 1 1 QSTESTCD= 114 115 QSTEST= 1-Skin So Dry That Feet Crack Open 1-Ever Had Amputation Yes 1 1 QSTESTCD= 117 QSTEST= 1-Right Foot Appears Normal No 1 1 QSTESTCD= 118 121 QSTEST= 1-Right Foot Deformities 1-Right Foot Fissure Checked Checked Unchecked Unchecked QSTESTCD= 123 QSTEST= 1-Left Foot Appears Normal No 1 1 QSTESTCD= 124 127 QSTEST= 1-Left Foot Deformities 1-Left Foot Fissure Checked Checked Unchecked Unchecked QSTESTCD= 129 130 1-Left Foot Ulceration QSTEST= 1-Right Foot Ulceration 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9
CDISC SDTM Questionnaire Supplement (Version 1.0) Absent 0 0 Present 1 1 QSTESTCD= 131 132 QSTEST= 1-Right Ankle Reflexes 1-Left Ankle Reflexes Present 0 0 Present/Reinforcement 0.5 0.5 Absent 1 1 QSTESTCD= 133 134 QSTEST= 1-Right Foot Vibration Great Toe 1-Left Foot Vibration Great Toe Present 0 0 Decreased 0.5 0.5 Absent 1 1 QSTESTCD= 135 136 QSTEST= 1-Right Foot Monofilament 1-Left Foot Monofilament Normal 0 0 Reduced 0.5 0.5 Absent 1 1 End of Document 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 10