Transcription of Kurtzke Expanded Disability Status Scale (EDSS)
1 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1 October 23, 2013 Kurtzke Expanded Disability Status Scale (EDSS) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by Multiple Sclerosis Outcomes Assessment Consortium 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 2013-09-26 Kurtzke Expanded Disability Status Scale (EDSS) Draft 2013-10-23 Kurtzke Expanded Disability Status Scale (EDSS) CDISC SDTM EDSS Questionnaire Supplement (Version ) 2013 Clinical Data Interchange Standards Consortium, Inc.
2 All rights reserved Page 2 October 23, 2013 1 Introduction This document describes the CDISC implementation of the Kurtzke Expanded Disability Status Scale (EDSS) questionnaire, a standard questionnaire that is typically used in clinical trials to measure the Disability Status of people with Multiple Sclerosis. The EDSS 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: ( ). These specific implementation details for this questionnaire are meant to be used in conjunction with the SDTMIG.
3 All questionnaire documentation can be found on the CDISC web site at: ( ). The CDISC Intellectual Property Policy can be found on the CDISC web site at: ( ). 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 Kurtzke Expanded Disability Status Scale (EDSS) as part of CDISC Data Standards.
4 Hence, CDISC developed QSTESTCD and QSTEST for each question based on the actual question text on the questionna ire. There may be many versions of this questionna ire 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. Note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should be accessed through the CDISC website. ( ) The reference for this questionnaire is: Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an Expanded Disability Status Scale (EDSS).
5 Neurology. 1983 Nov;33(11):1444-52. CDISC SDTM EDSS Questionnaire Supplement (Version ) 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3 October 23, 2013 3 The QS Domain Model 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 Kurtzke Expanded Disability Status Scale questionnaire are listed below. Kurtzke Expanded Disability Status Scale (EDSS): The EDSS is an ordinal clinical rating Scale ranging from 0 to 10 in half-point increments that measures the Disability Status of people with Multiple Sclerosis. 1. The Scale points include a rating ( ) and a definition of what is represented by the rating ( totally helpless bed patient; unable to communicate effectively or eat/swallow; (Usual Functional System Score (FS) equivalents are combinations, almost all grade 4+) ).
6 For EDSS, QSORRES is populated with the rating definition. QSSTRESC and QSSTRESN are populated with the numerical rating only. 2. Three of the rating definitions are longer than the 200 character limit currently mandated by the FDA, and hence, CDISC. The QS sub-team has paraphrased the text to shorten the responses. The original and modified values are summarized in Section 5. 3. The questionnaire evaluator is stored in QSEVAL. For EDSS, the evaluator is defined as INVESTIGATOR. Additional identifying information to further distinguish the rater in QSEVAL should be stored in QSEVALID. An example is rater initials. 4. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for qualifier, result and fields is provided in Section 4: SDTM Mapping Strategy.
7 CDISC SDTM EDSS Questionnaire Supplement (Version ) 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4 October 23, 2013 Example for Kurtzke Expanded Disability Status Scale (EDSS) QS Domain Model The EDSS example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for twenty subjects collected at one visit for an EDSS questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. QSBLFL is NULL based on VISITNUM=2. 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.
8 The following EXPECTED QS fields are not included in the example due to the footprint of the page: QSBLFL, QSEVAL. Rows 1-20: Show the question from the EDSS form. An example of each possible answer is shown. Rows 8,9,14: Have QSORRES values that needed to be shortened in order to meet the 200 character SAS transport file V5 restriction. Row S TUDYID DO MAIN US UBJID Q S SEQ Q S TES TC D Q S TES T Q S C AT Q S O RRES Q S S TRES C Q S S TRES N VIS ITNUM Q S DTC 1 ST UDYX QS P 0001 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS Normal neurological exam. 0 2 2012-11-16 2 ST UDYX QS P 0002 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS No disabilit y, minimal signs in one FS. 1 2 2012-11-16 3 ST UDYX QS P 0003 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS No disabilit y, minimal signs in more t han one FS.
9 2 2012-11-16 4 ST UDYX QS P 0004 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS Minimal disabilit y in one FS. 2 2 2012-11-16 5 ST UDYX QS P 0005 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS Minimal disabilit y in t wo FS. 2 2012-11-16 6 ST UDYX QS P 0006 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS Moderat e disabilit y in one FS or mild disabilit y in t hree or four FS t hough fully ambulat ory. 3 2 2012-11-16 7 ST UDYX QS P 0007 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS Fully ambulat ory but wit h moderat e disabilit y in one FS and one or t wo FS grade 2; or t wo FS grade 3 or five grade 2. 2 2012-11-16 8 ST UDYX QS P 0008 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS Fully ambulat ory wit hout aid, self-sufficient , up and about some 12 hours a day despit e relat ively severe disabilit y; able t o walk wit hout aid or rest some 500 met ers.
10 4 2 2012-11-16 CDISC SDTM EDSS Questionnaire Supplement (Version ) 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5 October 23, 2013 Row S TUDYID DO MAIN US UBJID Q S SEQ Q S TES TC D Q S TES T Q S C AT Q S O RRES Q S S TRES C Q S S TRES N VIS ITNUM Q S DTC 9 ST UDYX QS P 0009 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS Fully ambulat ory wit hout aid, up much of t he day, able t o work a full day, may have some limit at ion of full act ivit y or require minimal assist ance; able t o walk wit hout aid or rest some 300 met ers. 2 2012-11-16 10 ST UDYX QS P 0010 1 EDSS0101 EDSS01- Expanded Disabilit y Score EDSS Ambulat ory wit hout aid or rest for about 200 met ers; disabilit y severe enough t o impair full daily act ivities ( , t o work a full day wit hout special provisions).
