Barnes Akathisia Rating Scale () Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by 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 2013-05-15 1.0 Barnes Akathisia Rating Scale () Draft 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1
1 Introduction This document describes the CDISC implementation of the Barnes Akathisia Rating Scale () questionnaire, a standard questionnaire that is typically used in clinical trials to provide an assessment of akathisia. The 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. CDISC has included the Barnes Akathisia Rating Scale () 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. 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. (http://www.cdisc.org/terminology) CDISC has developed this documentation at no cost to users of the instrument. The reference for this questionnaire is: Barnes Akathisia Rating Scale () (Barnes TR: A Rating Scale for Drug-Induced Akathisia. British Journal of Psychiatry 154:672-676, 1989). 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2
3 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 Barnes Akathisia Rating Scale are listed below. Barnes Akathisia Rating Scale (): is a multiple-choice questionnaire that clinicians may use to provide an assessment of akathisia. Akathisia is defined by www.dictionary.com as a state of motor restlessness, sometimes produced by neuroleptic medication that ranges from a feeling of inner distress to an inability to sit still. 1. The investigator is instructed to observe the subject while standing and while sitting, at least two minutes each. There are four areas where the subject is to be evaluated, one of these is objective, two are subjective, and the final is a global assessment. 2. Six of the textual assessments, one of the objective and five of the global, are greater than the 200 characters limit currently mandated by the FDA, and hence, CDISC. To accommodate these in QSORRES the QS subteam has decided to shorten the responses to accommodate the character limit. The original and shortened values are summarized in Section 5. 3. Because the four minutes that the investigator must observe the subject is a minimum observation period, and not the actual evaluation interval, coupled with the fact that the investigator may use additional observations from other situations, there is not a value for the evaluation interval (QSEVLINT). 4. For, the evaluator is usually defined as INVESTIGATOR. Additional identifying information to further distinguish the rater in QSEVAL should be stored in QSEVALID. An example is rater initials. 5. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for qualifier, timing, result and unit fields is provided in Section 4: SDTM Mapping Strategy. 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3
3.2 Example for Barnes Akathisia Rating Scale () QS Domain Model The example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for four subjects collected at one visit for a questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. Rows 1-16 represent the questions from the form. All original results are represented with preferred terminology in QSORRES. This result is then standardized into its numeric equivalent in the character field of QSSTRESC, and this value is then transferred to the QSSTRESN field, in numeric format. Rows 4, 8, 12, 13, and 16 had QSORRES values that needed to be shortened in order to meet the 200 character SAS transport file V5 restriction. QS.XPT ROW STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC 1 STUDY001 QS 001-001 1 0101 01-Objective 2 STUDY001 QS 001-001 2 0102 3 STUDY001 QS 001-001 3 0103 Awareness Distress NORMAL, OCCASIONAL FIDGETY MOVEMENTS OF THE LIMBS NON-SPECIFIC SENSE OF INNER RESTLESSNESS 1 MODERATE 2 0 4 STUDY001 QS 001-001 4 0104 01-Global Clinical Assessment MILD AKATHISIA. AWARE OF RESTLESSNESS IN THE LEGS AND/OR INNER RESTLESSNESS WORSE WHEN REQUIRED TO STAND STILL. FIDGETY MOVEMENTS, BUT RESTLESS MOVEMENTS NOT NECESSARILY OBSERVED. LITTLE/NO DISTRESS. 2 5 STUDY001 QS 001-002 1 0101 01-Objective PATIENT IS CONSTANTLY ENGAGED IN CHARACTERISTIC RESTLESS MOVEMENTS, AND/OR HAS THE INABILITY TO REMAIN SEATED OR STANDING WITHOUT WALKING OR PACING, DURING THE TIME OBSERVED 3 6 STUDY001 QS 001-002 2 0102 7 STUDY001 QS 001-002 3 0103 Awareness Distress AWARENESS OF INTENSE COMPULSION TO MOVE MOST OF THE TIME AND/OR REPORTS STRONG DESIRE TO WALK OR PACE MOST OF THE TIME MODERATE 2 3 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4
ROW STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC 8 STUDY001 QS 001-002 4 0104 01-Global Clinical Assessment SEVERE AKATHISIA. A STRONG COMPULSION TO PACE UP AND DOWN MOST OF THE TIME. UNABLE TO SIT OR LIE DOWN FOR MORE THAN A FEW MINUTES. CONSTANT RESTLESSNESS ASSOCIATED WITH INTENSE DISTRESS AND INSOMNIA. 5 9 STUDY001 QS 001-003 1 0101 01-Objective OBSERVED PHENOMENA, AS DESCRIBED IN (1) ABOVE, WHICH ARE PRESENT FOR AT LEAST HALF THE OBSERVATION PERIOD 2 10 STUDY001 QS 001-003 2 0102 Awareness THE PATIENT IS AWARE OF AN INABILITY TO KEEP THE LEGS STILL, OR A DESIRE TO MOVE THE LEGS, AND/OR COMPLAINS OF INNER RESTLESSNESS AGGRAVATED SPECIFICALLY BY BEING REQUIRED TO STAND STILL 2 11 STUDY001 QS 001-003 3 0103 Distress MILD 1 12 STUDY001 QS 001-003 4 0104 01-Global Clinical Assessment MODERATE AKATHISIA. AWAREOF RESTLESSNESS AS DESCRIBED FOR MILD AKATHISIA ABOVE, COMBINED WITH CHARACTERISTIC RESTLESS MOVEMENTS SUCH AS ROCKING FROM FOOT TO FOOT WHEN STANDING. CONDITION DISTRESSING 3 13 STUDY001 QS 001-004 1 0101 01-Objective RESTLESS MOVEMENTS: SHUFFLING OR TRAMPING MOVEMENTS. SWINGING OF ONE LEG WHILE SITTING, AND/OR ROCKING FROM FOOT TO FOOT OR WALKING ON THE SPOT WHEN STANDING, PRESENT FOR LESS THAN HALF THE TIME 1 14 STUDY001 QS 001-004 2 0102 15 STUDY001 QS 001-004 3 0103 Awareness Distress NON-SPECIFIC SENSE OF INNER RESTLESSNESS 1 NO DISTRESS 0 16 STUDY001 QS 001-004 4 0104 01-Global Clinical Assessment ABSENT. NO EVIDENCE OF AWARENESS OF RESTLESSNESS. MOVEMENTS OF AKATHISIA IN THE ABSENCE OF INNER RESTLESSNESS OR COMPULSIVE DESIRE TO MOVE THE LEGS SHOULD BE CLASSIFIED AS PSEUDOAKATHISIA 0 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5
ROW QSSTRESN QSBLFL QSEVAL VISITNUM QSDTC 1 0 Y INVESTIGATOR 1 2013-01-08 2 1 Y INVESTIGATOR 1 2013-01-08 3 2 Y INVESTIGATOR 1 2013-01-08 4 2 Y INVESTIGATOR 1 2013-01-08 5 3 Y INVESTIGATOR 1 2013-01-08 6 3 Y INVESTIGATOR 1 2013-01-08 7 2 Y INVESTIGATOR 1 2013-01-08 8 5 Y INVESTIGATOR 1 2013-01-08 9 2 Y INVESTIGATOR 1 2013-01-10 10 2 Y INVESTIGATOR 1 2013-01-10 11 1 Y INVESTIGATOR 1 2013-01-10 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6
ROW QSSTRESN QSBLFL QSEVAL VISITNUM QSDTC 12 3 Y INVESTIGATOR 1 2013-01-10 13 1 Y INVESTIGATOR 1 2013-01-10 14 1 Y INVESTIGATOR 1 2013-01-10 15 0 Y INVESTIGATOR 1 2013-01-10 16 0 Y INVESTIGATOR 1 2013-01-10 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7
CDISC SDTM Questionnaire Supplement (Version 0.1) 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, QSSTRESC, and QSSTRESN) should be populated for the questionnaire. QSTESTCD=0101 QSTEST= 01-Objective QSORRES QSSTRESC QSSTRESN NORMAL, OCCASIONAL FIDGETY MOVEMENTS OF THE LIMBS 0 0 RESTLESS MOVEMENTS: SHUFFLING OR TRAMPING MOVEMENTS. SWINGING OF ONE LEG WHILE SITTING, AND/OR ROCKING FROM FOOT TO FOOT OR WALKING ON THE SPOT WHEN STANDING, PRESENT FOR LESS THAN HALF THE TIME OBSERVED PHENOMENA, AS DESCRIBED IN (1) ABOVE, WHICH ARE PRESENT FOR AT LEAST HALF THE OBSERVATION PERIOD PATIENT IS CONSTANTLY ENGAGED IN CHARACTERISTIC RESTLESS MOVEMENTS, AND/OR HAS THE INABILITY TO REMAIN SEATED OR STANDING WITHOUT WALKING OR PACING, DURING THE TIME OBSERVED 1 1 2 2 3 3 QSTESTCD=0102 QSTEST= Awareness QSORRES QSSTRESC QSSTRESN ABSENCE OF INNER RESTLESSNESS 0 0 NON-SPECIFIC SENSE OF INNER RESTLESSNESS 1 1 THE PATIENT IS AWARE OF AN INABILITY TO KEEP THE LEGS STILL, OR A DESIRE TO MOVE THE LEGS, AND/OR COMPLAINS OF INNER RESTLESSNESS AGGRAVATED SPECIFICALLY BY BEING REQUIRED TO STAND STILL AWARENESS OF INTENSE COMPULSION TO MOVE MOST OF THE TIME AND/OR REPORTS STRONG DESIRE TO WALK OR PACE MOST OF THE TIME 2 2 3 3 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8
CDISC SDTM Questionnaire Supplement (Version 0.1) QSTESTCD=0103 QSTEST= Distress QSORRES QSSTRESC QSSTRESN NO DISTRESS 0 0 MILD 1 1 MODERATE 2 2 SEVERE 3 3 QSTESTCD=0104 QSTEST= 01-Global Clinical Assessment QSORRES QSSTRESC QSSTRESN ABSENT. NO EVIDENCE OF AWARENESS OF RESTLESSNESS. MOVEMENTS OF AKATHISIA IN THE ABSENCE OF INNER RESTLESSNESS OR COMPULSIVE DESIRE TO MOVE THE LEGS SHOULD BE CLASSIFIED AS PSEUDOAKATHISIA 0 0 QUESTIONABLE. NON-SPECIFIC INNER TENSION AND FIDGETY MOVEMENTS 1 1 MILD AKATHISIA. AWARE OF RESTLESSNESS IN THE LEGS AND/OR INNER RESTLESSNESS WORSE WHEN REQUIRED TO STAND STILL. FIDGETY MOVEMENTS, BUT RESTLESS MOVEMENTS NOT NECESSARILY OBSERVED. LITTLE/NO DISTRESS. MODERATE AKATHISIA. AWAREOF RESTLESSNESS AS DESCRIBED FOR MILD AKATHISIA ABOVE, COMBINED WITH CHARACTERISTIC RESTLESS MOVEMENTS SUCH AS ROCKING FROM FOOT TO FOOT WHEN STANDING. CONDITION DISTRESSING MARKED AKATHISIA. RESTLESSNESS INCLUDES A COMPULSIVE DESIRE TO WALK OR PACE. HOWEVER, THE PATIENT IS ABLE TO REMAIN SEATED FOR AT LEAST FIVE MINUTES. THE CONDITION IS OBVIOUSLY DISTRESSING. SEVERE AKATHISIA. A STRONG COMPULSION TO PACE UP AND DOWN MOST OF THE TIME. UNABLE TO SIT OR LIE DOWN FOR MORE THAN A FEW MINUTES. CONSTANT RESTLESSNESS ASSOCIATED WITH INTENSE DISTRESS AND INSOMNIA. 2 2 3 3 4 4 5 5 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9
CDISC SDTM Questionnaire Supplement (Version 0.1) 5 Original and QSORRES Comparison 01-Objective (Original) NORMAL, OCCASIONAL FIDGETY MOVEMENTS OF THE LIMBS PRESENCE OF CHARACTERISTIC RESTLESS MOVEMENTS: SHUFFLING OR TRAMPING MOVEMENTS OF THE LEGS/FEET, OR SWINGING OF ONE LEG WHILE SITTING, AND/OR ROCKING FROM FOOT TO FOOT OR WALKING ON THE SPOT WHEN STANDING, BUT MOVEMENTS PRESENT FOR LESS THAN HALF THE TIME OBSERVED QSORRES Value NORMAL, OCCASIONAL FIDGETY MOVEMENTS OF THE LIMBS RESTLESS MOVEMENTS: SHUFFLING OR TRAMPING MOVEMENTS. SWINGING OF ONE LEG WHILE SITTING, AND/OR ROCKING FROM FOOT TO FOOT OR WALKING ON THE SPOT WHEN STANDING, PRESENT FOR LESS THAN HALF THE TIME OBSERVED PHENOMENA, AS DESCRIBED IN (1) ABOVE, WHICH ARE PRESENT FOR AT LEAST HALF THE OBSERVATION PERIOD PATIENT IS CONSTANTLY ENGAGED IN CHARACTERISTIC RESTLESS MOVEMENTS, AND/OR HAS THE INABILITY TO REMAIN SEATED OR STANDING WITHOUT WALKING OR PACING, DURING THE TIME OBSERVED Awareness (Original) ABSENCE OF INNER RESTLESSNESS NON-SPECIFIC SENSE OF INNER RESTLESSNESS THE PATIENT IS AWARE OF AN INABILITY TO KEEP THE LEGS STILL, OR A DESIRE TO MOVE THE LEGS, AND/OR COMPLAINS OF INNER RESTLESSNESS AGGRAVATED SPECIFICALLY BY BEING REQUIRED TO STAND STILL AWARENESS OF INTENSE COMPULSION TO MOVE MOST OF THE TIME AND/OR REPORTS STRONG DESIRE TO WALK OR PACE MOST OF THE TIME Distress (Original) NO DISTRESS MILD MODERATE SEVERE OBSERVED PHENOMENA, AS DESCRIBED IN (1) ABOVE, WHICH ARE PRESENT FOR AT LEAST HALF THE OBSERVATION PERIOD PATIENT IS CONSTANTLY ENGAGED IN CHARACTERISTIC RESTLESS MOVEMENTS, AND/OR HAS THE INABILITY TO REMAIN SEATED OR STANDING WITHOUT WALKING OR PACING, DURING THE TIME OBSERVED QSORRES Value ABSENCE OF INNER RESTLESSNESS NON-SPECIFIC SENSE OF INNER RESTLESSNESS THE PATIENT IS AWARE OF AN INABILITY TO KEEP THE LEGS STILL, OR A DESIRE TO MOVE THE LEGS, AND/OR COMPLAINS OF INNER RESTLESSNESS AGGRAVATED SPECIFICALLY BY BEING REQUIRED TO STAND STILL AWARENESS OF INTENSE COMPULSION TO MOVE MOST OF THE TIME AND/OR REPORTS STRONG DESIRE TO WALK OR PACE MOST OF THE TIME QSORRES Value NO DISTRESS MILD MODERATE SEVERE 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 10
CDISC SDTM Questionnaire Supplement (Version 0.1) 01-Global Clinical Assessment ABSENT. NO EVIDENCE OF AWARENESS OF RESTLESSNESS. OBSERVATION OF CHARACTERISTIC MOVEMENTS OF AKATHISIA IN THE ABSENCE OF A SUBJECTIVE REPORT OF INNER RESTLESSNESS OR COMPULSIVE DESIRE TO MOVE THE LEGS SHOULD BE CLASSIFIED AS PSEUDOAKATHISIA QSORRES Value ABSENT. NO EVIDENCE OF AWARENESS OF RESTLESSNESS. MOVEMENTS OF AKATHISIA IN THE ABSENCE OF INNER RESTLESSNESS OR COMPULSIVE DESIRE TO MOVE THE LEGS SHOULD BE CLASSIFIED AS PSEUDOAKATHISIA QUESTIONABLE. NON-SPECIFIC INNER TENSION AND FIDGETY MOVEMENTS MILD AKATHISIA. AWARENESS OF RESTLESSNESS IN THE LEGS AND/OR INNER RESTLESSNESS WORSE WHEN REQUIRED TO STAND STILL. FIDGETY MOVEMENTS PRESENT, BUT CHARACTERISTIC RESTLESS MOVEMENTS OF AKATHISIA NOT NECESSARILY OBSERVED. CONDITION CAUSES LITTLE OR NO DISTRESS. QUESTIONABLE. NON-SPECIFIC INNER TENSION AND FIDGETY MOVEMENTS MILD AKATHISIA. AWARE OF RESTLESSNESS IN THE LEGS AND/OR INNER RESTLESSNESS WORSE WHEN REQUIRED TO STAND STILL. FIDGETY MOVEMENTS, BUT RESTLESS MOVEMENTS NOT NECESSARILY OBSERVED. LITTLE/NO DISTRESS. MODERATE AKATHISIA. AWARENESS OF RESTLESSNESS AS DESCRIBED FOR MILD AKATHISIA ABOVE, COMBINED WITH CHARACTERISTIC RESTLESS MOVEMENTS SUCH AS ROCKING FROM FOOT TO FOOT WHEN STANDING. PATIENT FINDS THE CONDITION DISTRESSING MARKED AKATHISIA. SUBJECTIVE EXPERIENCE OF RESTLESSNESS INCLUDES A COMPULSIVE DESIRE TO WALK OR PACE. HOWEVER, THE PATIENT IS ABLE TO REMAIN SEATED FOR AT LEAST FIVE MINUTES. THE CONDITION IS OBVIOUSLY DISTRESSING. SEVERE AKATHISIA. THE PATIENT REPORTS A STRONG COMPULSION TO PACE UP AND DOWN MOST OF THE TIME. UNABLE TO SIT OR LIE DOWN FOR MORE THAN A FEW MINUTES. CONSTANT RESTLESSNESS WHICH IS ASSOCIATED WITH INTENSE DISTRESS AND INSOMNIA. MODERATE AKATHISIA. AWAREOF RESTLESSNESS AS DESCRIBED FOR MILD AKATHISIA ABOVE, COMBINED WITH CHARACTERISTIC RESTLESS MOVEMENTS SUCH AS ROCKING FROM FOOT TO FOOT WHEN STANDING. CONDITION DISTRESSING MARKED AKATHISIA. RESTLESSNESS INCLUDES A COMPULSIVE DESIRE TO WALK OR PACE. HOWEVER, THE PATIENT IS ABLE TO REMAIN SEATED FOR AT LEAST FIVE MINUTES. THE CONDITION IS OBVIOUSLY DISTRESSING. SEVERE AKATHISIA. A STRONG COMPULSION TO PACE UP AND DOWN MOST OF THE TIME. UNABLE TO SIT OR LIE DOWN FOR MORE THAN A FEW MINUTES. CONSTANT RESTLESSNESS ASSOCIATED WITH INTENSE DISTRESS AND INSOMNIA. End of Document 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 11