Alcohol Use Disorder Identification Test Self-Report Version (AUDIT-SR)

Transcription

1 Alcohol Use Disorder Identification Test Self-Report Version (AUDIT-SR) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by TBI Standards Team and the CDISC COA 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 Alcohol Use Disorder Identification Test Self-Report Version (AUDIT-SR) Draft Alcohol Use Disorder Identification Test Self-Report Version (AUDIT-SR) 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1

2 1 Introduction This document describes the CDISC implementation of the Alcohol Use Disorder Identification Test Self-Report Version (AUDIT-SR) questionnaire. The AUDIT-SR is a 10-item questionnaire that can help identify individuals who are hazardous drinkers or have alcohol use disorders (including alcohol abuse or dependence). The AUDIT-SR 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. 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: ( 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 Alcohol Use Disorder Identification Test Self-Report Version 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 instrument. 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 form 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. ( CDISC acknowledges the World Health Organization and the authors of the scale: Saunders JB, Aasland, OG, Babor, TF, De La Fuente JR, Grant M Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2

3 References: Saunders JB, Aasland, OG, Babor, TF, De La Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with harmful Alcohol Consumption II. Addiction (1993) 88: 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 Alcohol Use Disorder Identification Test Self-Report Version (AUDIT-SR) questionnaire are listed below. Alcohol Use Disorder Identification Test Self-Report Version (AUDIT-SR): The AUDIT-SR consists of 10 multiple choice items. The first eight items are rated on a 5- point ordinal rating scale, though the precise meaning of each number on the scale is not the same for all questions. The remaining two questions are rated on a 3-point ordinal rating scale. This version of the questionnaire is completed by the patient. 1. For all AUDIT-SR questions, results have a description associated with a number (e.g. 2-3 times a week is associated with the number 3 ), QSORRES is populated with the text description. The associated number is represented in QSSTRESC and QSSTRESN. a. The response descriptions are unique for the first two items, the same for items 3 through 8, and the same for items 9 and The number of each response is totaled for all questions to achieve the Total score which is stored in QSORRES, QSSTRESC, and QSSTRESN when QSTESTCD = ADT Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for qualifier and result fields is provided in Section 4: SDTM Mapping Strategy Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3

4 3.2 Example for Alcohol Use Disorders Identification Test Self-Report Version (AUDIT-SR) QS Domain Model The AUDIT-SR example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for one subject collected at one visit for an AUDIT-SR questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. QSBLFL is Y based on VISITNUM=1. All original results are represented with standard values 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 1-10: Represent the questions from the AUDIT-SR CRF. Row 11: The total score for Subject P0001. qs.xpt Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT 1 STUDYX QS P ADT0101 ADT01-How Often Drink Alcohol AUDIT-SR 2-3 times a week STUDYX QS P ADT0102 ADT01-Alcohol Drinks on a Typical Day AUDIT-SR 3 or STUDYX QS P ADT0103 ADT01-Six or More Drinks One Occasion AUDIT-SR Never STUDYX QS P ADT0104 ADT01-Not Able Stop Drinking Once Start AUDIT-SR Never STUDYX QS P ADT0105 ADT01-Failed to Do as Expected AUDIT-SR Monthly STUDYX QS P ADT0106 ADT01-Need Drink Morning After Drinking AUDIT-SR Weekly STUDYX QS P ADT0107 ADT01-Feeling of Guilt or Remorse AUDIT-SR Less than monthly STUDYX QS P ADT0108 ADT01-Unable to Remember What Happened AUDIT-SR Daily or almost daily STUDYX QS P ADT0109 ADT01-Injured Because of Your Drinking AUDIT-SR No STUDYX QS P ADT0110 ADT01-Suggested to Cut Down AUDIT-SR Yes, but not in the last year STUDYX QS P ADT0111 ADT01-Total AUDIT-SR Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 Row QSBLFL QSEVAL VISIT NUM QSDTC 1 (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT (cont) Y STUDY SUBJECT Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

6 4 SDTM Mapping Strategy AUDIT-SR 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. QSTESTCD=ADT0101 QSTEST= ADT01-How Often Drink Alcohol Never 0 0 Monthly or less times a month times a week or more times a week 4 4 QSTESTCD=ADT0102 QSTEST= ADT01-Drinks on a Typical Day 1 or or or to or more 4 4 QSTESTCD=ADT0103 QSTEST= ADT01-Six or More Drinks One Occasion QSTESTCD=ADT0104 QSTEST= ADT01-Not Able Stop Drinking Once Start QSTESTCD=ADT0105 QSTEST= ADT01-Failed to Do as Expected QSTESTCD=ADT0106 QSTEST= ADT01-Need Drink Morning After Drinking QSTESTCD=ADT0107 QSTEST= ADT01-Feeling of Guilt or Remorse QSTESTCD=ADT0108 QSTEST= ADT01-Unable to Remember What Happened Never 0 0 Less than monthly 1 1 Monthly 2 2 Weekly 3 3 Daily or Almost Daily 4 4 QSTESTCD=ADT0109 QSTEST= ADT01-Injured Because of Your Drinking QSTESTCD=ADT0110 QSTEST= ADT01-Suggested to Cut Down No 0 0 Yes, but not in the last year 2 2 Yes, during the last year 4 4 End of Document 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6