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Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

BPRS 1988 VERSION

QRS Permission StatusPublic Domain
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2020-12-11
NotesThis 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

DateVersion
2020-12-11
1.0 Draft

© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION) instrument.

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG 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.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

CDISC believes this instrument is to be in the public domain, but you should perform your own assessment. CDISC has included the BPRS 1988 VERSION in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. 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) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology.

Reference for the BPRS 1988 VERSION:

Overall, JE, Gorham DR: The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertainment and scaling. Psychopharmacology Bulletin 24:97-99, 1988.

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the BPRS 1988 VERSION are listed below.

The BPRS 1988 VERSION is a multiple-choice instrument that clinicians may use to record the severity of 18 distinct signs and symptoms of psychopathology based on clinical interview of a subject. It consists of 18 items, each rated on an 8-point scale. A total score between 0-126 is also captured.

  1. The scale points include a numeric rating (0-7) and a definition of what is represented by the rating (e.g., 0 = "Not assessed"). For the BPRS 1988 VERSION, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.

  2. The BPRS 1988 VERSION instrument includes a total score that is considered as captured data on the CRF and is not considered as derived in the example below.

    1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (See SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

  3. Terminology

    1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy. 

3.2 Example for the BPRS 1988 VERSION RS Domain Model

The BPRS 1988 VERSION example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit for the BPRS 1988 VERSION instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC.

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.


The table represents the items from the BPRS 1988 VERSION instrument.

rs.xpt

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSLOBXFLVISITNUMRSDTC
1STUDYXRSP00011BPRS0101BPRS01-Somatic ConcernBPRS 1988 VERSIONNot assessed00Y1

2015-11-01

2STUDYXRSP00012BPRS0102BPRS01-AnxietyBPRS 1988 VERSIONNot present11Y12015-11-01
3STUDYXRSP00013BPRS0103BPRS01-Emotional WithdrawalBPRS 1988 VERSIONVery mild22Y12015-11-01
4STUDYXRSP00014BPRS0104BPRS01-Conceptual DisorganizationBPRS 1988 VERSIONMild33Y12015-11-01
5STUDYXRSP00015BPRS0105BPRS01-Guilt FeelingsBPRS 1988 VERSIONModerate44Y12015-11-01
6STUDYXRSP00016BPRS0106BPRS01-TensionBPRS 1988 VERSIONModerately severe55Y12015-11-01
7STUDYXRSP00017BPRS0107BPRS01-Mannerisms and PosturingBPRS 1988 VERSIONSevere66Y12015-11-01
8STUDYXRSP00018BPRS0108BPRS01-GrandiosityBPRS 1988 VERSIONExtremely severe77Y12015-11-01
9STUDYXRSP00019BPRS0109BPRS01-Depressive MoodBPRS 1988 VERSIONNot present11Y12015-11-01
10STUDYXRSP000110BPRS0110BPRS01-HostilityBPRS 1988 VERSIONVery mild22Y12015-11-01
11STUDYXRSP000111BPRS0111BPRS01-SuspiciousnessBPRS 1988 VERSIONModerate44Y12015-11-01
12STUDYXRSP000112BPRS0112BPRS01-Hallucinatory BehaviorBPRS 1988 VERSIONModerately severe55Y12015-11-01
13STUDYXRSP000113BPRS0113BPRS01-Motor RetardationBPRS 1988 VERSIONSevere66Y12015-11-01
14STUDYXRSP000114BPRS0114BPRS01-UncooperativenessBPRS 1988 VERSIONExtremely severe77Y12015-11-01
15STUDYXRSP000115BPRS0115BPRS01-Unusual Thought ContentBPRS 1988 VERSIONMild33Y12015-11-01
16STUDYXRSP000116BPRS0116BPRS01-Blunted AffectBPRS 1988 VERSIONModerate44Y12015-11-01
17STUDYXRSP000117BPRS0117BPRS01-ExcitementBPRS 1988 VERSIONNot present11Y12015-11-01
18STUDYXRSP000118BPRS0118BPRS01-DisorientationBPRS 1988 VERSIONVery mild22Y12015-11-01
19STUDYXRSP000119BPRS0119BPRS01-Total ScoreBPRS 1988 VERSION636363Y12015-11-01
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4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.

RSTESTCD = "BPRS0101" RSTEST = "BPRS01-Somatic Concern" through

RSTESTCD = "BPRS0118" RSTEST = "BPRS01-Disorientation"


RSORRESRSSTRESCRSSTRESN
Not assessed00
Not present11
Very mild22
Mild33
Moderate44
Moderately severe55
Severe66
Extremely severe77


End of Document

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