ADAS-Cog Questionnaire Supplement to the Study Data ...

1 CDISC SDTM ADAS-Cog Questionnaire Supplement (Version ) 2011 Clinical data Interchange Standards Consortium, Inc. All rights reserved ADAS-Cog Questionnaire Supplement to the Study data tabulation model Implementation Guide Prepared by the Coalition Against Major Diseases (CAMD) Notes to Readers This implementation guide follows version ( ) of the CDISC Submission data Standards and domain models. Revision History Date Version Summary of Changes 2011-09-09 Draft Alzheimer s Disease Assessment Scale-Cognitive ( ADAS-Cog ) Questionnaire 2011-12-27 Alzheimer s Disease Assessment Scale-Cognitive ( ADAS-Cog ) Questionnaire release 2012-01-26 Alzheimer s Disease Assessment Scale-Cognitive ( ADAS-Cog ) Questionnaire release revised with inclusion of copyright appendix Note: Please see 1570 HAppendix F for Representations and Warranties, Limitations of Liability, and Disclaimers.

2 CDISC SDTM ADAS-Cog Questionnaire Supplement (Version ) Page 2 2011 Clinical data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011 CONTENTS 6 DOMAIN MODELS BASED ON THE GENERAL OBSERVATION CLASSES .. 3 FINDINGS .. 3 Questionnaire QS Alzheimer s Disease Assessment Scale Cognitive ( ADAS-Cog ) .. 3 Assumptions for Questionnaire Domain model .. 3 Examples for Alzheimer s Disease ASSESSMENT SCALE Questionnaire Domain model .. 4 APPENDICES .. 13 Appendix 2: Mapping Strategy for SDTM Variables .. 14 Appendix 3: SUPPLEMENTAL Qualifiers Name Codes .. 20 Appendix F: Representations and Warranties, Limitations of Liability, and Disclaimers .. 21 CDISC SDTM ADAS-Cog Questionnaire Supplement (Version ) 2011 Clinical data Interchange Standards Consortium, Inc.

3 All rights reserved Page 3 January 26, 2011 6 Domain Models Based on the General Observation Classes FINDINGS Questionnaire QS ALZHEIMER S DISEASE ASSESSMENT SCALE COGNITIVE ( ADAS-Cog ) See SDTMIG for QS domain table. The documentation for this Questionnaire is located on the CDISC website in the Members Only Section. The link is: All Questionnaire documentation is being stored together in a separate location because many questionnaires are utilized across many different disease areas. The CDISC Questionnaire Terminology Team is in the process of assessing copyright issues and developing controlled terminology for additional questionnaires. This site will be updated on a regular basis with new questionnaires.. CDISC acknowledges Dr.

4 Richard Mohs for his agreement to include the ADAS-Cog scale in the CDISC data standards. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. 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 assumptions apply to Alzheimer s disease Assessment Scale Cognitive. 1. Alzheimer s Disease Assessment Scale Cognitive ( ADAS-Cog ): ADAS-Cog is a standard clinical scale used in Alzheimer s disease studies. ADAS-Cog scale has been implemented in a number of different methods. The most common implementation is to collect a subset of the 15 summary questions.

5 A certified reviewer provides the scores based on a worksheet which contains all the detailed information recorded in the sub-items. In this approach the sub-item scores are not recorded. The certified reviewer enters the summary scores on the CRF/eCRF. In this case QSDRVFL is NULL. Another approach is to collect the detailed results which include individual sub-items that are used to derive the summary questions. This includes the results of individual trials of specific questions within the ADAS-Cog scale. Summary scores are derived by the sponsor via the detailed questions. In this case QSDRVFL is set to Y for the derived summary record. CDISC SDTM ADAS-Cog Questionnaire Supplement (Version ) Page 4 2011 Clinical data Interchange Standards Consortium, Inc.

6 All rights reserved January 26, 2011 The ADAS-Cog example below shows the correct terminology for QSCAT, QSSCAT, QSTEST, QSTESTCD and QSORRES that should be utilized for this scale. Values for QSORRES are for prospective data collection. Sponsors mapping legacy data may retain legacy values for QSORRES. 2. The ADAS-Cog scale collects the reason why specific questions were not completed. The sponsor specifc terminology for the reason the question was not answered are condensed to be either Cognitive reasons or Non-Cognitive reasons as part of the ADAS-Cog data standard. The following table indicates how the QSSTAT and QSREASND fields are populated when the detailed questions are captured and the summary questions are derived. Based on SDTM rules for these fields, the QSORRES field is blank when QSSTAT=Y or a result is derived (SDTMIG page 47).

7 In the ADAS-Cog scale, when the summary question is NOT DONE for Cognitive reasons , the derived score is populated with the worse value (.ex 5 ) as follows: QSORRES=NULL QSSTRESC=5 QSSTRESN=5 QSDRVFL=Y QSSTAT=NULL QSREASND=NULL. If the NOT DONE reason is Non-Cognitive reasons , a missing value (.ex NULL ) is derived as follows: QSORRES=NULL QSSTRESC=NULL QSSTRESN=NULL QSDRVFL=Y QSSTAT=NULL QSREASND=NULL. This logic indicates that it is not the derivation that is NOT DONE ; but it the underlying detailed questions used as the source data for the derivation that were NOT DONE . Those detail records would be marked as NOT DONE as follows: QSORRES=NULL QSSTRESC=NULL QSSTRESN=NULL QSDRVFL=NULL QSSTAT=NOT DONE QSREASND= Cognitive reasons or Non-Cognitive reasons.

8 The interpretation of these derived summary question results is based on the detailed question results. For derived summary questions with QSSTRESN=5 or NULL, the interpretation of the not done result is based on the QSSTAT and QSREASND values of the detailed questions results. When the ADAS-Cog data is collected by a certified reviewer, who enters the summary question results, the population of QSSTAT and QSREASND is handled as follows QSORRES=NULL QSSTRESC=5 QSSTRESN=5 QSDRVFL=NULL QSSTAT=NOT DONE QSREASND=Cognitive reasons or QSORRES=NULL QSSTRESC=NULL QSSTRESN=NULL QSDRVFL=NULL QSSTAT=NOT DONE QSREASND=Non-Cognitive reasons. 3. QS ADAS-Cog specific mapping strategy for the following fields is listed in Appendix 1. a. QSTPT, QSTPTNUM, QSORRES, QSSTRESC and QSSTRESN EXAMPLES FOR ALZHEIMER S DISEASE ASSESSMENT SCALE Questionnaire DOMAIN model Example 1: Alzheimer s disease Assessment Scale Cognitive ( ADAS-Cog ) CDISC SDTM ADAS-Cog Questionnaire Supplement (Version ) 2011 Clinical data Interchange Standards Consortium, Inc.

9 All rights reserved Page 5 January 26, 2011 This example shows data from two subjects collected at one visit for an ADAS-Cog Questionnaire with the detailed questions collected and the the summary question derived. The example uses standard controlled terminology for QSSPID, QSTESTCD, QSTEST, QSCAT and QSSCAT for the ADAS-Cog scale. Summary rows are shaded and detailed rows are not shaded. In order to show the concepts and for ease of use in review not all of the detailed rows are shown; these rows have .. in them. For example, rows 4-11 are represented by one row and use the .. notation. In these rows, STUDYID, DOMAIN, USUBJID, QSCAT, and QSSCAT do not change with regards to row 3. However, QSSEQ, QSSPID, QSTESTCD, and QSTEST with .. all increment by 1 following the same naming convention as the previous value.

10 QSORRES and QSTRESC would be populated with the actual data . The variables STUDYID=STUDYX, DOMAIN=QS and QSSTRESN are not shown in the example due to page width limitations. Rows 1, 35, 53, 59, 70, 76, 82, 91, 167-172, 176: Represent the 15 possible summary questions from the ADAS-Cog Form. All original results are represented with the standard terminology in QSORRES. This result is then transformed into a Standard Numeric score from 0-5 in QSSTRESN, which is then also copied to a standard character value in QSSTRESC. All summary scores can either be entered by a certified evaluator or they can be derived via the detailed questions for each summary score. When derived, QSDRVLFL is set to Y . Rows 2-12, 13-23, 24-34: Represent the 3 possible Word Recall trials.