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© 2022 Clinical 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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For the first version of a supplement, use the above Revision History table and delete this information box. When a previously published supplement is being revised, a modified "Revision History" table will need to be used. Add a new column at the right called "Summary of Changes" if this is the first revision to the supplement (see table below). Also add a new row under the column headers with the current information, keeping all rows previously added. The bottom row should be for Version 1.0, with subsequent versions added above each of the previous rows. If you are making changes to a supplement for the first time, put "Initial Final Version" in the Summary of Changes column for Version 1.0. Then add a row above with the new version number (1.1 if the changes are considered minor such as a typo, 2.0 if they are major such as variable changes) and summary of changes. Revision History
© 2022 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. |
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For public domain instruments use the following text: CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the QRS Short_Name 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. There may be many versions of this instrument. 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) CRF(s) annotated with the CDISC SDTMIG variables with submission values.
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The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF. |
Insert the CDISC copyright or Exempt from Copyright CDISC text that is included in each of the –CAT CT CDISC Definition. This same text is annotated as a text box on the annotated CRF.
These materials discuss and/or include one or more of the SF Health Surveys, which are owned exclusively by QualityMetric Incorporated. No part of the SF Health Surveys 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 QualityMetric Incorporated and payment of any applicable fees. Copyright QualityMetric Incorporated All rights reserved.
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: These materials discuss and/or include the Patient Health Questionnaire - 9 (PHQ-9) which is owned exclusively by the Pfizer. Inc. Use of the PHQ-9 is subject to Pfizer. Inc. terms of use. See (https://www.cdiscphqscreeners.org/standards/terminology/controlled-terminology.
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Include the following statements as standalone paragraphs for copyrighted instruments: 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 [insert the name of the copyright holder, in blue text] (e.g., Dr. A. J. Rush, at the UT Southwestern Medical Center) for the approval to include the QRS Short_Name in the CDISC data standards. |
Reference for the QRS Short_Name:
Rush, A.J., Carmody, T. and Reimitz, P.E. The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and self-report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9:45-59, 2000.
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This is an example only. Use the reference from the CDISC definition of the --CAT.
If there are multiple references, please use the following format: References for the QRS Short_Name:
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Notes on the use of quotation marks:
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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 QRS Short_Name are listed below.
The QRS Short_Name is a multiple-choice instrument that clinicians may use to assess the severity of depressive symptoms. It consists of 30 items, each rated on a 4-point scale. A total score between 0-84 is also captured.
com/select-screener). PHQ-9 copyright 2001, Pfizer. Inc.
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.
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The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF. |
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.
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Include the following statements as standalone paragraphs for copyrighted instruments: 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 [insert the name of the copyright holder, in blue text] (e.g., Dr. A. J. Rush, at the UT Southwestern Medical Center) for the approval to include the QRS Short_Name in the CDISC data standards. Only include the actual references and all material used in developing the supplement on the reference section below. This should be a reference paper or a website reference in place of a paper. |
Reference for the QRS Short_Name:
Rush, A.J., Carmody, T. and Reimitz, P.E. The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and self-report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9:45-59, 2000.
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This is an example only. Use the reference from the CDISC definition of the --CAT.
If there are multiple references, please use the following format: References for the QRS Short_Name:
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Notes on the use of quotation marks:
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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 QRS Short_Name are listed below.
The QRS Short_Name is a multiple-choice instrument that clinicians may use to assess the severity of depressive symptoms. It consists of 30 items, each rated on a 4-point scale. A total score between 0-84 is also captured.
Include a description of scale score or other possible responses (You may need multiple numbered points for this, tho the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleep"). For the QRS Short_Name, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. (replace this sentence for instruments with text only responses with “QSORRES and QSSTRESC are populated with the text description and QSSTRESN is not represented with a numeric value”.
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.:
If numeric use this wording: The time period of evaluation for theQRS Short_Name is populated in the --EVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the QRS Short_Name is the past 7 days (--EVLINT = "-P7D").
- If text use this wording: The time period of evaluation for the QRS Short_Name is populated in the --EVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the QRS Short_Name is "LIFETIME" (--EVINTX = "LIFETIME"
Include a description of scale score or other possible responses (You may need multiple numbered points for this, tho the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleep"). For the QRS Short_Name, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. (replace this sentence for instruments with text only responses with “QSORRES and QSSTRESC are populated with the text description and QSSTRESN is not represented with a numeric value”.
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.:
- If numeric use this wording: The time period of evaluation for theQRS Short_Name is populated in the --EVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the QRS Short_Name is the past 7 days (--EVLINT = "-P7D"). If text use this wording: The time period of evaluation for the QRS Short_Name is populated in the --EVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the QRS Short_Name is "LIFETIME" (--EVINTX = "LIFETIME").
- If there are subcategories, include a note that subcategories will be represented in QSSCAT. Also provide a list of the subcategories unless one is already provided in the description preceding the assumptions. Remove this point if it does not apply. For example: 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 = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.
If the instrument standards currently being developed includes logically skipped conditionally branched items, insert: Some items on the QRS Short_Name may be logically skipped conditionally branched 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 conditionally branched 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 a conditionally branched item, it is represented as follows::
When assigned conditionally branched responses are not documented in the instrument’s instructions or a user manual:
- QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y” (this is a QS supplemental qualifier variable related to the record).
- QSORRES, QSSTRESC, and QSSTRESN
RSSTAT = "NOT DONE".
RSREASND = "LOGICALLY SKIPPED ITEM".
- RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).
When assigned conditionally branched responses are documented in instructions or a user manual:
- QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y” (this is a QS supplemental qualifier variable).
- The QSORRES responses are represented as follows:
- For severity items, QSORRES = "None".
- For interference items, QSORRES = "Not at all".
- If numeric response values are assigned, they are represented here: QSSTRESC = 0 and QSSTRESN = 0.
or If no numeric responses are assigned: QSSTRESC = NULL and QSSTRESN = NULL.
Include this point if score(s) are submitted to SDTM. Update blue text: The QRS Short_Name instrument includes a total score (and subscores or other scores as needed. If so, change "that is" to "that are") that is considered as captured data on the instrument 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.].
- Subtotal and total scores are represented in--ORRES, --STRESC, and --STRESN.
- If scores are received or derived by the
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 ADaM whenever feasible.
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,Please review the decision on not including –EVAL and --EVALID in the QRS Supplement Best Practices topic “--EVAL/–EVALID not included in QRS domains/datasets”.Now we only represent administrative information if it is explicitly collected on an instrument. No assumptions are made for this data; if it's not on the instrument, it's not in the data.
The SUPPQUAL variables used are a series of non-standard variables that represent collected administrator information, administration device, etc., and these updated SUPPQUAL variables are included in the WIKI non-standard variable registry (Non-standard Variable Registry). For example:
- PPRAID which is "Preprinted Administrator Identifier".
- COLAVL which is "Collected Administrator Value".
The supplement version 1.0 of the FAS-NACC UDS V3.0 instrument shows an implementation example.
The QRS Short_Name instrument collects administrative information as the preprinted examiner’s initials and the collected response. This is represented in the SUPPQUAL variable QNAM = --PPRAID” with QNAM = “Preprinted Administrator Identifier” and QVAL = “EXAMINER’S INITIALS”. The collected initials response is represented with QNAM = “--COLAID” and QNAM = “Collected Administrator Identifier” and QVAL = “ADM1”.
This is part of the data example for the SUPPQUAL variables.
The SUPPRS table represents the preprinted and collected administrative items represented on the CRF.
supprs.xpt
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.STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
STUDYX
RS
100-10001
RSCAT
FAS-NACC UDS V3.0
RSPPRAID
Preprinted Administrator Identifier
EXAMINER'S INITIALS
CRF
STUDYX
RS
100-10001
RSCAT
FAS-NACC UDS V3.0
RSCOLAID
Collected Administrator Identifier
ADM1
CRF
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.
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
QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN (and other variables such as QSORRESU as needed; only include QSORRES, QSSTRESC, and QSSTRESN if the responses are published in CT with public domains instruments) values are included in CDISC Controlled Terminology.
A full list of value sets for the qualifier, timing, result, and unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)
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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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