Information for Reviewers
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Revision History
| Date | Version |
|---|---|
| 2021-03-01 | 1.0 Draft |
© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
1 Introduction
This document describes the CDISC implementation of the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Palliative Care Version 1.0 (EORTC QLQ-C15-PAL V1.0) 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) Questionnaires (QS) 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 web site at: https://www.cdisc.org/standards/foundational/qrs.
The CDISC Intellectual Property Policy can be found on the CDISC web site 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
EORTC owns the copyright for the EORTC QLQ-C15-PAL V1.0 instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. EORTC will distribute the CDISC supplement package to sponsors when they are approved to use this instrument. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.
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.
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/controlled-terminology.
CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.
CDISC acknowledges Andrew Bottomley at EORTC for the approval to include the EORTC QLQ-C15-PAL V1.0 in the CDISC data standards.
Reference for the EORTC QLQ-C15-PAL V1.0:
Copyright 1995 and 2005 EORTC Quality of Life Group. All rights reserved. Version 1.0.
3 The QS Domain Model
3.1 Assumptions for the QS Domain Model
All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the EORTC QLQ-C15-PAL V1.0 are listed below.
The EORTC QLQ-C15-PAL V1.0 is a multiple-choice instrument that that clinicians may use to assess the quality of life of palliative cancer care subjects. It consists of 14 items, each rated on a 4-point Likert scale plus 1 item rated on a 7-point numeric rating scale.
The scale points include a 4-point Likert scale (1-4) and a 7-point numeric rating (1-7) and a definition of what is represented by the rating (e.g., 1 = "Not at all"). For the EORTC QLQ-C15-PAL V1.0, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
The time period of evaluation for the EORTC QLQ-C15-PAL V1.0 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the EORTC QLQ-C15-PAL V1.0 is the past week for QSTESTCD="EOR0204" thru "EOR0215".
Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.
3.2 Example for the EORTC QLQ-C15-PAL V1.0 QS Domain Model
The EORTC QLQ-C15-PAL V1.0 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline and the second visit for a EORTC QLQ-C15-PAL V1.0 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.
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 EORTC QLQ-C15-PAL V1.0 instrument. The subject did not fill out the instrument at VISITNUM = 2.
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 QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.
QSTESTCD ="EOR0201" QSTEST = "EOR02-Trouble Taking Short Walk Outside" through
QSTESTCD = "EOR0214" QSTEST = "EOR02-Did You Feel Depressed"
| QSORRES | QSSTRESC | QSSTRESN |
| Not at All | 1 | 1 |
| A Little | 2 | 2 |
| Quite a Bit | 3 | 3 |
| Very Much | 4 | 4 |
QSTESTCD = "EOR0215" QSTEST = "EOR02-Rate Your Overall Quality of Life"
| QSORRES | QSSTRESC | QSSTRESN |
| Very poor | 1 | 1 |
| 2 | 2 | 2 |
| 3 | 3 | 3 |
| 4 | 4 | 4 |
| 5 | 5 | 5 |
| 6 | 6 | 6 |
| Excellent | 7 | 7 |
End of Document
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