Clinical Global Impression (CGI)

Transcription

1 Clinical Global Impression (CGI) 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 Clinical Global Impression Questionnaire (CGI) Draft Clinical Global Impression Questionnaire (CGI)

2 1 Introduction This document describes the CDISC implementation of the Clinical Global Impression questionnaire, a standard questionnaire administered on a CRF that is typically used in clinical trials to measure pain response. The CGI CRF 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 table, which can be found at the CDISC website at These 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 ( 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 Clinical Global Impression Questionnaire (CGI) 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. The reference for this questionnaire is: Guy W, editor. ECDEU Assessment Manual for Psychopharmacology Rockville, MD, U.S. Department of Health, Education, and Welfare 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2

3 3 The QS Domain Model 3.1 Assumptions for the CGI 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 assumptions apply to the Clinical Global Impression Questionnaire: Clinical Global Impression Questionnaire (CGI): CGI is amongst the most widely used of extant brief assessment tools in psychiatry. The CGI is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response. The illness severity and improvement sections of the instrument are used more frequently than the therapeutic response section in both clinical and research settings. The Early Clinical Drug Evaluation Program (ECDEU) version of the CGI (reproduced here) is the most widely used format, and asks that the clinician rate the patient relative to their past experience with other patients with the same diagnosis, with or without collateral information. The CGI has proved to be a robust measure of efficacy in many clinical drug trials, and is easy and quick to administer, provided that the clinician knows the patient well The evaluator of the questionnaire is stored in QSEVAL and for the GCI form the INVESTIGATOR is the primary evaluator, but flexibility is provided for the evaluation by the SUBJECT also. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for QSORRES, QSSTRESC and QSSTRESN fields is provided in Section 4: Mapping Strategy Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3

4 3.2 Example for CLINICAL GLOBAL IMPRESSION QUESTIONNAIRE Domain Model The CGI 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. Example: Clinical Global Impression Questionnaire (CGI) This example shows data from one subject collected at two visits for a CGI questionnaire. The example uses standard controlled terminology for QSTESTCD, QSTEST, QSCAT and QSSORRES for the CGI measure. QSORRESU and QSSTRESU are not displayed, since there are no unit values used in this questionnaire. Rows 1-6: Represent the 3 detail questions from the CGI Form. All original results are represented with the standard terminology in QSORRES. This result is then transformed into a Standard Numeric score in QSSTRESN. QS.XPT Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSEVAL VISITNUM 1 STUDYX QS 1 CGI0101 Severity of CGI Severely ill 6 6 INVESTIGATOR 1 illness Global 2 STUDYX QS 2 CGI0102 CGI Much worse 6 6 INVESTIGATOR 1 improvement 3 STUDYX QS 4 STUDYX QS 5 STUDYX QS 6 STUDYX QS 3 CGI CGI CGI CGI0103 Efficacy index Severity of illness Global improvement Efficacy index CGI Unchanged or worse - None INVESTIGATOR 1 CGI Markedly ill 5 5 INVESTIGATOR 2 CGI Minimally worse 5 5 INVESTIGATOR 2 CGI Minimal - Do not significantly interfere with patient s functioning INVESTIGATOR Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 4 SDTM Mapping Strategy CGI 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= CGI0101 QSTEST= Severity of illness QSORRES QSSTRESC QSSTRESN Not assessed 0 0 Normal, not at all ill 1 1 Borderline mentally ill 2 2 Mildly ill 3 3 Moderately ill 4 4 Markedly ill 5 5 Severely ill 6 6 Among the most extremely ill patients 7 7 QSTESTCD= CGI0102 QSTEST= Global improvement QSORRES QSSTRESC QSSTRESN Not assessed 0 0 Very much improved 1 1 Much improved 2 2 Minimally improved 3 3 No change 4 4 Minimally worse 5 5 Much worse 6 6 Very much worse 7 7 QSTESTCD= CGI0103 QSTEST= Efficacy index The Efficacy Index is determined by the intersection of a Therapeutic Effect and Side Effects result on the CRF. QSORRES QSSTRESC QSSTRESN Not accessed 0 0 Marked - None 1 1 Marked - Do not significantly interfere with patient s functioning 2 2 Marked - Significantly interferes with patient s functioning 3 3 Marked Outweighs therapeutic effect 4 4 Moderate - None 5 5 Moderate - Do not significantly interfere with patient s functioning 6 6 Moderate - Significantly interferes with patient s functioning Clinical Data Interchange Standards Consortium, Inc. All rights reserved

6 QSORRES QSSTRESC QSSTRESN Moderate Outweighs therapeutic effect 8 8 Minimal - None 9 9 Minimal - Do not significantly interfere with patient s functioning Minimal - Significantly interferes with patient s functioning Minimal Outweighs therapeutic effect Unchanged or worse - None Unchanged or worse - Do not significantly interfere with patient s functioning Unchanged or worse - Significantly interferes with patient s functioning Unchanged or worse Outweighs therapeutic effect End of Document 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6