...

...

Revision History

© 2022 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.

...

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.

...

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.

...

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.

...

1. The scale points include a 4-point Likert scale (1-4) and a 7-point numeric rating (1-7), with 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.

2.  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".

3. QSTESTCD = "EOR0215" item is represented as a Numeric Rating Scale 7-Point item. Visual analog or numeric rating scales used within a questionnaire with a range of text and numeric values are indicated in the SUPPQS domain with:

   QNAM=QSANTXLO      QNAM=QSANTXHI

   QNAM=QSANVLLO     QNAM=QSANVLHI

   By storing this information in SUPPQS, it is available for interpretation purposes.  The SDS QS Team is researching alternative methods to handle this data in the future, but until a new method is identified, this will be the recommended approach.

   1. The low and high anchor text is stored in QSORRES with the numeric values stored in QSSTRESC and QSSTRESN.  All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN.

4. Terminology

   1. QSCAT, QSTESTCD, and QSTEST 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 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, matching the CRF item response text, are represented in QSORRES.This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.

...

The table represents the items from the EORTC QLQ-C15-PAL V1.0 instrument instrument. The subject did not fill out the instrument at the scheduled VISITNUM = 2Rows 16-30 show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

The anchor text and numeric values for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

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.

...

5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

...