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Revision History

© 2022 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Functional Assessment of Cancer Therapy-Hepatobiliary Version 4 (FACT-HEP V4)

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

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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.

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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

David Cella, PhD. , owns the copyright for the FACT-HEP V4 instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. 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.

These materials discuss and/or include the FACIT Measurement System, which is owned exclusively by Dr. David Cella. No part of the FACIT Measurement System may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Dr. David Cella and payment of any applicable fees. Copyright Dr. David Cella. All rights reserved.  Copyright 1987, 1997 David Cella, PhD.

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 Dr. David Cella and FACIT.org for CDISC acknowledges Dr. David Cella and FACIT.org, for the approval to include the FACT-HEP V4 in the CDISC data standards.

Reference for the FACT-HEP V4:

• Copyright 1987, 1997 David Cella, Ph.D.
• These materials discuss and/or include FACIT Measurement System, which is owned exclusively by Dr. David Cella. No part of the FACIT Measurement System may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Dr. David Cella and payment of any applicable fees. Copyright Dr. David Cella. All rights reserved.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

• FACIT.org for more information as well as the scoring guide.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the FACT-HEP V4 are listed below.

The FACT-HEP V4 is a multiple-choice health-related quality of life questionnaire about problems associated with hepatobiliary cancer. It consists of 45 items rated on a 5-point scale. The FACT-G is included as the first 27 items in the FACT-HEP V4. 

1. All All items rated on a 5-point scale include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "Not at all", 4 = "Very much"). For the FACT-HEP V4, QSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

   1. FAC01514 may be rated on a 5-point scale or the subject may prefer not to answer. When the checkbox is marked that the subject prefers not to rate answer the item, this is noted with QSSTAT = "NOT DONE" and QSREASND = "PREFER NOT TO ANSWER". QSORRES, QSSTRESC, and QSSTRESN are all missing.

2. The time period of evaluation for the FACT-HEP V4 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 FACT-HEP V4 is the past 7 days (QSEVLINT = "-P7D").

3. Items are divided into 5 subcategories represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".

4. Records are created in qs.xpt for every item on the instrument: 

   1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE".  If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "LOGICALLY SKIPPED ITEM" or QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

5. The FACT-HEP V4 instrument includes subscale scores for each subcategory in addition to trial outcome index, FACT-G, and total scores per FACIT.org's scoring materials and are considered as captured data on the CRF and are not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from FACIT.org.

   1. Subscores and total scores are represented in QSORRES.

   2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
6. 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 QRS FACT-HEP V4 QS Domain Model

The FACT-HEP V4 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 visit for the FACT-HEP V4 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.

Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.

For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:

The following table represents the items from the FACT-HEP V4 instrument. 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, and no date is assumed for when the visit would have occurred.

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When the reason is collected for a not done visit, information or a row description should be added as follows:

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