Hospital Anxiety and Depression Scale (HADS)

Hospital Anxiety and Depression Scale (HADS) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by Business & Decision Life Sciences 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 2014-06-04 1.0 Hospital Anxiety and Depression Scale (HADS) Draft 2014-06-13 1.0 Hospital Anxiety and Depression Scale (HADS) 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved page 1

1 Introduction This document describes the CDISC implementation of the Hospital Anxiety and Depression Scale (HADS), a self-assessment scale that is typically used in clinical trials to detect states of depression and anxiety. The HADS 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: (http://www.cdisc.org/sdtm). 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: (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 or copyright approved. CDISC has included the Hospital Anxiety and Depression Scale (HADS) 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 questionnaire in the public domain or copyright questionnaire. 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 SDTM-IG submission values. Note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should be accessed through the CDISC website. (http://www.cdisc.org/terminology) CDISC has developed this documentation at no cost to users of the instrument. CDISC acknowledges A. S. Zigmond and R. P. Snaith The Hospital Anxiety and Depression Scale (HADS) (copyright 1983, 1992, 1994 by R.P. Snaith and A.S. Zigmond. All rights reserved)" for the agreement to include Hospital Anxiety and Depression Scale (HADS) in the CDISC data standards. 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved page 2

Further information about the development of the HADS can be found in the article The Hospital Anxiety and Depression Scale, A. S. Zigmond and R. P. Snaith, Acta psychiatrica Scandinavica. 1983:67:361-370.. 3 The QS Domain Model 3.1 Assumptions for Questionnaire Domain Model All assumptions and business rules described in the SDTM-IG QS domain are applicable to this supplement. Additional assumptions specific to the Hospital Anxiety and Depression Scale are listed below. Hospital Anxiety and Depression Scale (HADS): HADS is a self-report questionnaire consisting of 16 items, the first 14 of which are scored. Subjects rate the 14 items on a five-point scale (0-4). The 15 th and 16th items represent the total anxiety and depression score of the questionnaire. Completing the questionnaire by the patient is done in approximately 20 minutes. Scoring by the physician takes approximately 1 minute. 1. The time period of evaluation for the HADS is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. Typically, the evaluation interval for HADS is the past week. 2. The questionnaire method is stored in QSMETHOD. For HADS, the method is defined as the NUMERIC RATING SCALE 4-POINT. 3. The questionnaire evaluator is stored in QSEVAL. For HADS, the evaluator is defined as the STUDY SUBJECT for the first 14 questions, since the instrument is self-administered. For questions 15 and 16, the evaluator is defined as the INVESTIGATOR. 4. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for qualifier, timing and result fields is provided in Section 4: SDTM Mapping Strategy. 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved page 3

3.2 Example for Hospital Anxiety and Depression Scale (HADS) QS Domain Model The HADS 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 a HADS questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. This example is based on a questionnaire with an evaluation interval of the past week. QSBLFL is NULL based on VISITNUM = 2. All original text results are populated in QSORRES. A standard numeric score is represented in QSSTRESN and a character representation of the standard numeric score in QSSTRESC. Rows 1-14: Represents the questions from the HADS form. Rows 15, 16: Represents the anxiety and depression total scores, which can either be entered or may be derived from the individual questions on the HADS CRF. When derived, QSDRVFL is set to Y. All 7 questions for anxiety and depression are summed separately to obtain the total scores. qs.xpt Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT 1 STUDYX QS P0001 1 HADS0101 HADS01-I Feel Tense or Wound Up HADS ANXIETY Most of the time 3 3 2 STUDYX QS P0001 2 HADS0102 HADS01-Enjoy the Things I Used to Enjoy HADS DEPRESSION Only a little 2 2 3 STUDYX QS P0001 3 HADS0103 HADS01-Something Awful About to Happen HADS ANXIETY 4 STUDYX QS P0001 4 HADS0104 HADS01-I Can Laugh and See Funny Side HADS DEPRESSION Not quite so much now 1 1 5 STUDYX QS P0001 5 HADS0105 HADS01-Worrying Thoughts Go Through Mind HADS ANXIETY Not too often 1 1 6 STUDYX QS P0001 6 HADS0106 HADS01-I Feel Cheerful HADS DEPRESSION Never 3 3 7 STUDYX QS P0001 7 HADS0107 HADS01-Sit at Ease and Feel Relaxed HADS ANXIETY Usually 1 1 8 STUDYX QS P0001 8 HADS0108 HADS01-I Feel as if I am Slowed Down HADS DEPRESSION Very often 2 2 9 STUDYX QS P0001 9 HADS0109 HADS01-Butterflies in the Stomach HADS ANXIETY Very often 3 3 10 STUDYX QS P0001 10 HADS0110 HADS01-Lost Interest in My Appearance HADS DEPRESSION Definitely 3 3 11 STUDYX QS P0001 11 HADS0111 HADS01-Feel Restless be on the Move HADS ANXIETY Quite a lot 2 2 12 STUDYX QS P0001 12 HADS0112 HADS01-Look Forward with Enjoyment HADS DEPRESSION Hardly at all 3 3 13 STUDYX QS P0001 13 HADS0113 HADS01-I Get Sudden Feelings of Panic HADS ANXIETY Not a t all 0 0 14 STUDYX QS P0001 14 HADS0114 HADS01-Enjoy Good book/radio/television HADS DEPRESSION Often 0 0 15 STUDYX QS P0001 15 HADS0115 HADS01-Total Score Anxiety HADS ANXIETY 10 10 10 16 STUDYX QS P0001 16 HADS0116 HADS01-Total Score Depression HADS DEPRESSION 14 14 14 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

Row QSMETHOD QSBLFL QSEVAL VISITNUM QSDTC QSDY QSEVLINT 1 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 2 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 3 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 4 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 5 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 6 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 7 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 8 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 9 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 10 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 11 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 12 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 13 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 14 (cont) NUMERICAL RATING SCALE 4-POINT STUDY SUBJECT 2 2012-11-16 25 -P1W 15 (cont) INVESTIGATOR 2 2012-11-16 25 -P1W 16 (cont) INVESTIGATOR 2 2012-11-16 25 -P1W 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

4 SDTM Mapping Strategy HADS 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. If a result variable is not included in the table for a questionnaire, it should not be populated. QSSCAT ANXIETY DEPRESSION Applicable to QSTESTCD HADS0101-HADS0103-HADS0105- HADS0107-HADS0109-HADS0111- HADS0113 HADS0102-HADS0104-HADS0106- HADS0108-HADS0110-HADS0112- HADS0114 QSMETHOD NUMERICAL RATING SCALE 4-POINT Applicable to QSTESTCD HADS0101-HADS0114 QSTESTCD = HADS0101, QSTEST= HADS01-I Feel Tense or Wound Up From time to time, occasionally 1 1 A lot of the time 2 2 Most of the time 3 3 QSTESTCD = HADS0102, QSTEST= HADS01-Enjoy the Things I Used to Enjoy Definitely as much 0 0 Not quite so much 1 1 Only a little 2 2 Hardly at all 3 3 QSTESTCD = HADS0103, QSTEST= HADS01-Something Awful About to Happen A little, but it doesn t worry me 1 1 Yes, but not too badly 2 2 Very definitely quite badly 3 3 QSTESTCD = HADS0104, QSTEST= HADS01-I Can Laugh and See Funny Side As much as I always could 0 0 Not quite so much now 1 1 Definitely not so much now 2 2 Not at all 3 3 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6

QSTESTCD = HADS0105, QSTEST= HADS01-Worrying Thoughts Go Through Mind Very little 0 0 Not too often 1 1 A lot of the time 2 2 A great deal of the time 3 3 QSTESTCD = HADS0106, QSTEST= HADS01-I Feel Cheerful Most of the time 0 0 Sometimes 1 1 Not often 2 2 Never 3 3 QSTESTCD = HADS0107, QSTEST= HADS01-Sit at Ease and Feel Relaxed Definitely 0 0 Usually 1 1 Not often 2 2 Not at all 3 3 QSTESTCD = HADS0108, QSTEST= HADS01-I Feel as if I am Slowed Down Sometimes 1 1 Very often 2 2 Nearly all the time 3 3 QSTESTCD = HADS0109, QSTEST= HADS01-Butterflies in the Stomach Occasionally 1 1 Quite often 2 2 Very often 3 3 QSTESTCD = HADS0110, QSTEST= HADS01-Lost Interest in My Appearance I take just as much care as ever 0 0 I may not take quite as much care 1 1 I don t take as much care as I should 2 2 Definitely 3 3 QSTESTCD = HADS0111, QSTEST= HADS01-Feel Restless be on the Move Not very much 1 1 Quite a lot 2 2 Very much indeed 3 3 QSTESTCD = HADS0112, QSTEST= HADS01-Look Forward with Enjoyment 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7

As much as I ever did 0 0 Rather less than I used to 1 1 Definitely less than I used to 2 2 Hardly at all 3 3 QSTESTCD = HADS0113, QSTEST= HADS01-I Get Sudden Feelings of Panic Not very often 1 1 Quite often 2 2 Very often indeed 3 3 QSTESTCD = HADS0114, QSTEST= HADS01-Enjoy Good book/radio/television Often 0 0 Sometimes 1 1 Not often 2 2 Very seldom 3 3 End of Document 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8