Hamilton Depression Rating Scale -Item ( ) 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 Hamilton Depression Rating Scale -Item ( ) Draft 2012-08-07 1.0 Hamilton Depression Rating Scale -Item ( )
CDISC SDTM Questionnaire Supplement (Version 1.0) 1 Introduction This document describes the CDISC implementation of the Hamilton Depression Rating Scale -Item () 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 copyright 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 specific 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 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. CDISC has included the Hamilton Depression Rating Scale -Item ( ) 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 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 Hamilton Depression Rating Scale -Item: Hamilton Depression Rating Scale -Item ( ): is a multiple choice questionnaire that clinicians may use to rate the severity of a subject's major depression. It consists of questions, all of which contribute to the total score. Although the original Hamilton Depression Rating Scale had questions, others later developed with different numbers of questions. The time period of evaluation of the assessment is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. For the evaluation interval is over the past week. The evaluator of the questionnaire is stored in QSEVAL and for the form the INVESTIGATOR provides the evaluation. 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 Hamilton Depression Rating Scale -Item 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: Hamilton Depression Rating Scale -ITEM ( ) This example shows data from one subject collected at one visit for an questionnaire. The example uses standard controlled terminology for QSTESTCD, QSTEST, QSCAT and QSSORRES for the measure. is usually captured multiple times in a study. VISITNUM=1 is not displayed, due to the page width limitation. Rows 1-18: Represent the questions from the Form. All original results are represented with the standard terminology in QSORRES. This result is then transformed into a Standard Numeric score in QSSTRESN. Rows 19: Represents the summary score. 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. QS.XPT Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSDRVFL QSEVAL QSEVLINT 1 STUDYX QS 2 STUDYX QS 01 2 102 1-Depressed Mood 1-Feelings of Guilt INVESTIGATOR -P1W Self reproach, feels he/she has let people down Ideas or gestures suicide No difficulty falling asleep INVESTIGATOR -P1W 3 STUDYX QS 3 103 1-Suicide 3 3 INVESTIGATOR -P1W 1-Insomnia 4 STUDYX QS 4 104 Early - Early Night 0 0 INVESTIGATOR -P1W 1-Insomnia 5 STUDYX QS 5 105 Middle - Middle Night No difficulty 0 0 INVESTIGATOR -P1W 1-Insomnia 6 STUDYX QS 6 106 Early Hours -Morning No difficulty 0 0 INVESTIGATOR -P1W 1-Work and 7 STUDYX QS 7 107 Activities No difficulty 0 0 INVESTIGATOR -P1W 8 STUDYX QS 8 108 1-Retardation Complete stupor 4 4 INVESTIGATOR -P1W 9 STUDYX QS 9 109 1-Agitation Fidgetiness INVESTIGATOR -P1W 1-Anxiety 10 STUDYX QS 10 110 Psychic No difficulty 0 0 INVESTIGATOR -P1W 1-Anxiety 11 STUDYX QS 111 Somatic Moderate INVESTIGATOR -P1W 1-Somatic 12 STUDYX QS 12 112 Symptoms GI None 0 0 INVESTIGATOR -P1W 1-General 13 STUDYX QS 13 113 None 0 0 INVESTIGATOR -P1W Somatic Symptoms 14 STUDYX QS 14 114 1-Genital Mild INVESTIGATOR -P1W 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4
CDISC SDTM Questionnaire Supplement (Version 1.0) Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSDRVFL QSEVAL QSEVLINT Symptoms 1-15 STUDYX QS 15 115 Not present 0 0 INVESTIGATOR -P1W Hypochondriasis Definite (according 1-Loss of WT 16 STUDYX QS 16 116A to patient) weight INVESTIGATOR -P1W According to Patient loss STUDYX QS 18 STUDYX QS 19 STUDYX QS 116B 1-Loss of WT According to WK Meas 18 -Insight 19 118 1-Total Score Greater than 2 lb weight loss in week INVESTIGATOR -P1W Denies being ill at INVESTIGATOR -P1W all 18 18 18 Y INVESTIGATOR -P1W 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5
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. QSTESTCD=101 QSTEST= 1-Depressed Mood These feeling states indicated only on questioning These feeling states spontaneously reported verbally Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep 3 3 Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication 4 4 QSTESTCD=102 QSTEST= 1-Feelings of Guilt Self reproach, feels he/she has let people down Ideas of guilt or rumination over past errors or sinful deeds Present illness is a punishment. Delusions of guilt 3 3 Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations 4 4 QSTESTCD=103 QSTEST= 1-Suicide Feels life is not worth living Wishes he/she were dead or any thoughts of possible death to self Ideas or gestures of suicide 3 3 Attempts at suicide (any serious attempt rates 4) 4 4 QSTESTCD=104 QSTEST= 1-Insomnia Early - Early Night No difficulty falling asleep 0 0 Complains of occasional difficulty falling asleep, i.e. 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6
CDISC SDTM Questionnaire Supplement (Version 1.0) more than ½ hour Complains of nightly difficulty falling asleep QSTESTCD=105 QSTEST= 1-Insomnia Middle - Middle Night No difficulty 0 0 Patient complains of being restless and disturbed during the night Waking during the night any getting out of bed rates 2 (except for purposes of voiding) QSTESTCD=106 QSTEST= 1-Insomnia Early Hours - Morning No difficulty 0 0 Waking in early hours of the morning but goes back to sleep Unable to fall asleep again if he/she gets out of bed QSTESTCD=107 QSTEST= Work and Activities No difficulty 0 0 Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies Loss of interest in activity, hobbies or work either directly reported by patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities) Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding 3 3 routine chores Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted 4 4 QSTESTCD=108 QSTEST= 1-Retardation Normal speech and thought 0 0 Slight retardation during the interview Obvious retardation during the interview Interview difficult 3 3 Complete stupor 4 4 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7
CDISC SDTM Questionnaire Supplement (Version 1.0) QSTESTCD=109 QSTEST= 1-Agitation None 0 0 Fidgetiness Playing with hands, hair, etc. Moving about, can t sit still 3 3 Hand wringing, nail biting, hair-pulling, biting of lips 4 4 QSTESTCD=110 QSTEST= 1-Anxiety Psychic No difficulty 0 0 Subjective tension and irritability Worrying about minor matters Apprehensive attitude apparent in face or speech 3 3 Fears expressed without questioning 4 4 QSTESTCD=111 QSTEST= 1-Anxiety Somatic Mild Moderate Severe 3 3 Incapacitating 4 4 QSTESTCD=112 QSTEST= 1-Somatic Symptoms GI None 0 0 Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen Difficulty eating without staff urging. Requests or requires laxatives or medications for bowels or medication for gastro-intestinal symptoms QSTESTCD=113 QSTEST= 1-General Somatic Symptoms None 0 0 Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability Any clear-cut symptom rates 2 QSTESTCD=114 QSTEST= 1-Genital Symptoms Mild 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8
CDISC SDTM Questionnaire Supplement (Version 1.0) Severe QSTESTCD=115 QSTEST= 1-Hypochondriasis Not present 0 0 Self-absorption (bodily) Preoccupation with health Frequent complaints, requests for help, etc. 3 3 Hypochondriacal delusions 4 4 QSTESTCD=116A QSTEST= 1-Loss of WT According to Patient No weight loss 0 0 Probable weight loss associated with present illness Definite (according to patient) weight loss Not assessed 3 3 QSTESTCD=116B QSTEST= 1-Loss of WT According to WK Meas Less than 1 lb weight loss in week 0 0 Greater than 1 lb weight loss in week Greater than 2 lb weight loss in week Not assessed 3 3 QSTESTCD=1 QSTEST= 1-Insight Acknowledges being depressed and ill 0 0 Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc. Denies being ill at all End of Document 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9