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Title

Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 (NSCLC-SAQ V1.0)

CDISC Reference

Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

QRS Short Name

NSCLC-SAQ V1.0

QRS Permission StatusApproved
TeamLung Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusFinal
Date20202022-0301-1006
Notes
  • This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

Revision History

...

  • This instrument is a US FDA Qualified Clinical Outcome Assessment (COA)
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    instrument.


Revision History

DateVersion
2022-01-061.0

© 2022 © 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 (NSCLC-SAQ V1.0), a patient-reported outcome (PRO) questionnaireinstrument

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.  

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 questionnaire instrument is based

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on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain modemodel,
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l, which  which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this questionnaire instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

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.

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

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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

Critical Path Institute owns the copyright for the NSCLC-SAQ V1.0 and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. 

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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.

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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 Critical acknowledges the Critical Path Institute for approval

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to include the NSCLC-SAQ V1.0 in the CDISC data standards.

Reference for the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 ( NSCLC-SAQ V1.0):

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  • Patient-Reported Outcome (PRO) Consortium - Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Provisional User Manual, Version 6: March 24, 2017.
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    Version 1.0 Copyright 2015 Critical Path Institute. All Rights Reserved.
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  • McCarrier KP, Atkinson TM, DeBusk KP, Liepa AM, Scanlon M, Coons SJ and on behalf of the Patient-Reported Outcome Consortium. Qualitative Development and Content Validity of the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), A Patient-reported Outcome Instrument. Clinical Therapeutics 2016; 38(4):794-810.
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    2016; 38(4):794-810.

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 NSCLC-SAQ V1.0 are listed below.

The NSCLC-SAQ V1.0 is a PRO questionnaire to assess key symptoms of advanced non-small cell lung cancer (NSCLC) over the past 7 days as an endpoint measure in clinical trials. It consists of 7 items addressing the following 5 NSCLC concept domains: cough, pain, dyspnea, fatigue, and appetite. These concept domains are described in the manual which will be received upon user copyright approval.

  1. Respondents respond to each of the 7 items using a 5-point verbal rating scale from either "No <symptom> at All" to "Very Severe <symptom>", or from "Never" to "Always", (depending on the item's question structure) relative to either intensity or frequency. For the NSCLC-SAQ V1.0, QSORRES is populated with the text description of the rating scale response chosen.  

  2. In most cases, the NSCLC-SAQ V1.0 will be administered electronically. No score is displayed for any item on the questionnaire in either the paper form or the electronic format; however, the user manual for the CRF includes the standardized representation of 0 (e.g., "No Coughing at All”, “No Pain at All”, “Never”) through 4 (e.g., “Very Severe Coughing”, "Very Severe Pain", “Always”). Because (a) electronic administration is expected frequently, (b) instructions are provided in the user manual for scoring from C-Path's PRO Consortium, and (c) the numeric score for each question is expected to be submitted with the data, CDISC will represent the standardized scores in QSSTRESC and QSSTRESN.

  3. The time period of evaluation for the NSCLC-SAQ 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 NSCLC-SAQ V1.0 is the past 7 days.

  4. A total score ranging from 0-20, not collected on the NSCLC-SAQ V1.0 CRF, may be submitted as an Electronic Data Transfer (eDT) along with the individual item data for the NSCLC-SAQ V1.0. This original result will be recorded in QSORRES and a standardized representation of the score will be populated in QSSTRESC and QSSTRESN when it is included. The NSCLC-SAQ V1.0 total score is considered as captured data on the CRF and is not considered as derived in the example below.

    1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score written on a CRF will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to Y. However, when the subtotal and total scores are received from a central provider or vendor, the value would go into QSORRES and QSDRVFL would be null (See SDTMIG Section: 4.1.8.1, Origin Metadata for Variables).

  5. Subscores for the NSCLC-SAQ V1.0 concept domains (e.g., cough) will be derived in the Analysis Data Model (ADaM).

  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 NSCLC-SAQ V1.0 QS Domain Model

The NSCLC-SAQ 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 visit for a NSCLC-SAQ 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.

The table represents the questions from the NSCLC-SAQ V1.0 form. This example is based on a questionnaire with an evaluation interval of the past 7 days. Row 8 shows the total score for the NSCLC-SAQ V1.0.

This instrument is intended to be administered electronically per the user manual but a paper option exists if electronic administration is not possible. See the user manual for further details.

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The NSCLC-SAQ V1.0 is a PRO instrument that assesses key symptoms

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of advanced non-small cell lung cancer (NSCLC) over the past 7 days as an endpoint measure in clinical trials.
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These concept domains are described in the manual which will be received upon user copyright approval.

  1. Each of the 7 items is rated on a 5-point verbal rating scale

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    from either "No <symptom> at All" to "Very Severe <symptom>", or from "Never" to "Always" (depending on the item's question structure), relative to either intensity or frequency. For the NSCLC-SAQ V1.0, QSORRES is populated with the text description of the rating scale response chosen.  

  2. No score is displayed for any item on the instrument in either the paper form or the electronic format; however, the user manual for the CRF includes the standardized representation of zero (e.g., "No Coughing at All”, “No Pain at All”, “Never”) through 4 (e.g., “Very Severe Coughing”, "Very Severe Pain", “Always”). Because (a) electronic administration is expected frequently, (b) instructions are provided in the user manual

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    for scoring from C-Path's PRO Consortium, and (c) the numeric score for each question is expected to be submitted with the data, CDISC will represent the standardized scores in QSSTRESC and QSSTRESN.

  3. The time period of evaluation for the NSCLC-SAQ 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 NSCLC-SAQ V1.0 is the past 7 days.

  4. If no response is provided for an item, then QSORRES, QSSTRESC, and QSSTRESN are all set to null and QSSTAT = “NOT DONE”.

  5. A total score, ranging from 0-20, and 5 subscores, not collected on the NSCLC-SAQ V1.0 CRF but documented in the user manual, are considered as captured data and are not considered as derived in the example below.

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     These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from  user manual.

    1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL 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 (--DRVFL) is set to Y.

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      However, when the subtotal and total scores are received from a central provider or vendor, the value would go into QSORRES and
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      would be null (See SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

    2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.

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  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 NSCLC-SAQ V1.0 QS Domain Model

The NSCLC-SAQ V1.0 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 2 subjects collected at the baseline visit for a NSCLC-SAQ 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.

The table represents the items from the NSCLC-SAQ V1.0 instrument

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Rows 14-26 show the subject was not evaluated on this instrument at visit 1. Because the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. 
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Subtotal and total score calculations are referenced in the copyrighted user manual.

Info
titleSubjects missing visit information abbreviate

The second subject's missing VISITNUM-1 items were abbreviated by representing the first 3 items and then using the "..." approach to indicate that all items up to the last item represented were missing. We would like input regarding whether you (1) agree with this approach or (2) prefer that all items should be listed in the missing-visit use case moving forward.

Dataset wrap
Nameqs
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011NSCLC101NSCLC1-Rate Coughing at WorstNSCLC-SAQ V1.0Moderate Coughing22
Y1

2015-05-15

-P7D
2STUDYXQS2324-P00012NSCLC102NSCLC1-Rate Worst Pain in Chest

NSCLC-SAQ V1.0

Mild Pain11
Y12015-05-15-P7D
3STUDYXQS2324-P00013NSCLC103NSCLC1-Rate Worst Pain Other Than ChestNSCLC-SAQ V1.0Mild Pain11
Y12015-05-15-P7D
4STUDYXQS2324-P00014NSCLC104NSCLC1-Short of Breath Usual ActivitiesNSCLC-SAQ V1.0Sometimes22
Y12015-05-15-P7D
5STUDYXQS2324-P00015NSCLC105NSCLC1-How Often Low EnergyNSCLC-SAQ V1.0Sometimes22
Y12015-05-15-P7D
6STUDYXQS2324-P00016NSCLC106NSCLC1-How Often Tire EasilyNSCLC-SAQ V1.0Sometimes22
Y12015-05-15-P7D
7STUDYXQS2324-P00017NSCLC107NSCLC1-How Often Poor AppetiteNSCLC-SAQ V1.0Never00
Y12015-05-15-P7D
8STUDYXQS2324-P00018NSCLC108NSCLC1-Cough Domain SubscoreNSCLC-SAQ V1.0222
Y12015-05-15-P7D
9STUDYXQS2324-P00019NSCLC109NSCLC1-Fatigue Domain SubscoreNSCLC-SAQ V1.0222
Y12015-05-15-P7D
10STUDYXQS2324-P000110NSCLC110NSCLC1-Pain Domain SubscoreNSCLC-SAQ V1.0111
Y12015-05-15-P7D
11STUDYXQS2324-P000111NSCLC111NSCLC1-Dyspnea Domain SubscoreNSCLC-SAQ V1.02
Dataset wrap
Nameqs
Dataset2
1YY
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011NSCLC101NSCLC1-Rate Coughing at WorstNSCLC-SAQ V1.0Moderate Coughing22
Y12015-05-15-P7D
212STUDYXQS2324-P0001212NSCLC102NSCLC112NSCLC1-Rate Worst Pain in ChestAppetite Domain SubscoreNSCLC-SAQ V1.0Mild Pain0100
Y12015-05-15-P7D
313STUDYXQS2324-P0001313NSCLC103NSCLC108NSCLC1-Rate Worst Pain Other Than ChestTotal ScoreNSCLC-SAQ V1.0Mild Pain

7

1717
Y12015-05-15-P7D
414STUDYXQS2324-P0001P000241NSCLC104NSCLC101NSCLC1-Short of Breath Usual ActivitiesRate Coughing at WorstNSCLC-SAQ V1.0Sometimes22Y


NOT DONE
1



2015-05-15-P7D5STUDYXQS2324-P0001P000252NSCLC105NSCLC102NSCLC1-How Often Low EnergyRate Worst Pain in Chest

NSCLC-SAQ V1.0

Sometimes22


NOT DONE
12015-05-15-P7D

616STUDYXQS2324-P0001P000263NSCLC106NSCLC103NSCLC1-How Often Tire EasilyRate Worst Pain Other Than ChestNSCLC-SAQ V1.0Sometimes22


NOT DONE
12015-05-15-P7D
7STUDYXQS2324-P00017NSCLC107NSCLC1-How Often Poor AppetiteNSCLC-SAQ V1.0Never00Y12015-05-15-P7D


................................................
268STUDYXQS2324-P0001P0002813NSCLC108NSCLC1-Total ScoreNSCLC-SAQ V1.0

7

77Y12015-05-15




NOT DONE
1-P7D


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.

...