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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.
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Notes on the use of quotation marks:
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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
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FACT-HEP V4 is a multiple-choice
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health-related quality of life questionnaire about problems associated with hepatobiliary cancer. It consists of
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45 items
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rated on a
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5-point scale
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.
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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
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= "Not at all", 4 = "Very much"). For
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the FACT-HEP V4, QSORRES is populated with the text description
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; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
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Include a description of the evaluation interval if one exists. This may be numeric (QSEVLINT) or text (QSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use QSEVINTX instead of "QSEVLINT field in ISO 8601 format" and replace "the past 7 days" with the text (e.g., "DAYTIME'". Refer to SDTMIG Section 2.2.5 Timing Variables for All Classes. The evaluation interval needs to be clearly defined on the CRF. Remove this point if it does not apply.:
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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 the item, this is noted with QSSTAT = "NOT DONE" and QSREASND = "PREFER NOT TO ANSWER". QSORRES, QSSTRESC, and QSSTRESN are all missing.
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").
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".
Records are created in qs.xpt for every item on the instrument:
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.
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.
Subscores and total scores are represented in QSORRES.
- If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
- Terminology
QSCAT, QSTESTCD, and QSTEST values
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Records are created in qs.xpt for every item on the instrument:
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 = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.
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If the instrument standards currently being developed includes logically skipped items, insert: Some items on the QRS Short_Name may be logically skipped per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a logically skipped item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min). A record is created in rs.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:
RSSTAT = "NOT DONE".
RSREASND = "LOGICALLY SKIPPED ITEM".
RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).
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Include this point if score(s) are submitted to SDTM. Update blue text: The QRS Short_Name instrument includes a total score (and other scores as needed. If so, change "that is" to "that are") that is considered as captured data on the CRF and is 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 [Insert copyright holder's name or other source.].
If operationally defined by the sponsor, it is the sponsor's responsibility to set the QSDRVFL 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 (QSDRVFL) 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 QSDRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).Subtotal and total scores are represented in QSORRES.- If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
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This language is currently under review. Evaluator information is only to be included when the information is collected directly on the CRF. instruments will no longer be using QSEVAL/QSEVALID; however RSEVAL/RSEVALID and FTEVAL/FTEVALID will continue to be used on Clinical Classifications and Functional Tests. Language for Clinical Classifications and Functional tests follows; language for instruments is currently under review. Remove this point if it does not apply.
For Clinical Classifications and Functional Tests (only when collected on the CRF): *** This section to be updated. QSEVAL/ID, FTEVAL/ID, and RSEVAL/ID will no longer be used. Supplemental qualifiers will represent this information. *** For QRS Short_Name, the evaluator is defined as the (the appropriate term from controlled terminology). Alternatively, if only evaluator name or initials could be collected: For QRS Short_Name, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. CDISC Controlled Terminology is available for Evaluator (e.g., --EVAL = "HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., --EVALID = "RATER 1"). To reiterate, only include this point if the evaluator/administrator is collected directly on the CRF.
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Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the QRS Short_Name will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.
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Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the QRS Short_Name items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit.
Terminology
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are included in CDISC Controlled Terminology.
A full list of value sets for
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the result field is provided in Section 4, SDTM Mapping Strategy
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3.2 Example for the QRS
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FACT-HEP V4 QS Domain Model
The QRS Short_Name 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 QRS Short_Name instrumentthe 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. When there are numeric results, then use this sentence next, "This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC." When the results are character only, then use these sentences next, "This result is then transformed into the standard character representation in QSSTRESC. QSSTRESN is null as there are no standardized numeric results for this instrument."
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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:
When the reason is collected for a not done visit, information or a row description should be added as follows:
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