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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 Status Approved Team Lung Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam Supplement Version 1.0 Status Final Date 20202022-0301-1006 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. This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-275 instrument.

Revision History

© 2020 2022 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.

...

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 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.
• 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

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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. 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 questionnaire to assess key symptoms 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. It consists of 7 items addressing the following 5 NSCLC concept domains: cough, pain, dyspnea, fatigue, and appetite.

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These concept domains are described in the manual which will be received upon user copyright approval.

1. Respondents respond to each of Each of the 7 items using 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. In most cases, the NSCLC-SAQ V1.0 will be administered electronically. No score is displayed for any item on the questionnaire instrument in either the paper form or the electronic format; however, the user manual for the CRF includes the standardized representation of 0 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 , 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 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 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.

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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 QSDRVFL

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      would be null (See SDTMIG Section : 4.1.8.1, Origin Metadata for Variables).

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

   1. 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 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 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 questions items 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 V1.0instrument

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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
title Subjects 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
Name qs
Dataset2 Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSSTAT QSLOBXFL VISITNUM QSDTC QSEVLINT 1 STUDYX QS 2324-P0001 1 NSCLC101 NSCLC1-Rate Coughing at Worst NSCLC-SAQ V1.0 Moderate Coughing 2 2 Y 1 2015-05-15 -P7D 2 STUDYX QS 2324-P0001 2 NSCLC102 NSCLC1-Rate Worst Pain in Chest NSCLC-SAQ V1.0 Mild Pain 1 1 Y 1 2015-05-15 -P7D 3 STUDYX QS 2324-P0001 3 NSCLC103 NSCLC1-Rate Worst Pain Other Than Chest NSCLC-SAQ V1.0 Mild Pain 1 1 Y 1 2015-05-15 -P7D 4 STUDYX QS 2324-P0001 4 NSCLC104 NSCLC1-Short of Breath Usual Activities NSCLC-SAQ V1.0 Sometimes 2 2 Y 1 2015-05-15 -P7D 5 STUDYX QS 2324-P0001 5 NSCLC105 NSCLC1-How Often Low Energy NSCLC-SAQ V1.0 Sometimes 2 2 Y 1 2015-05-15 -P7D 6 STUDYX QS 2324-P0001 6 NSCLC106 NSCLC1-How Often Tire Easily NSCLC-SAQ V1.0 Sometimes 2 2 Y 1 2015-05-15 -P7D 7 STUDYX QS 2324-P0001 7 NSCLC107 NSCLC1-How Often Poor Appetite NSCLC-SAQ V1.0 Never 0 0 Y 1 2015-05-15 -P7D 8 STUDYX QS 2324-P0001 8 NSCLC108 NSCLC1-Cough Domain Subscore NSCLC-SAQ V1.0 2 2 2 Y 1 2015-05-15 -P7D 9 STUDYX QS 2324-P0001 9 NSCLC109 NSCLC1-Fatigue Domain Subscore NSCLC-SAQ V1.0 2 2 2 Y 1 2015-05-15 -P7D 10 STUDYX QS 2324-P0001 10 NSCLC110 NSCLC1-Pain Domain Subscore NSCLC-SAQ V1.0 1 1 1 Y 1 2015-05-15 -P7D 11 STUDYX QS 2324-P0001 11 NSCLC111 NSCLC1-Dyspnea Domain Subscore NSCLC-SAQ V1.0 2 2 2 Y 1 2015-05-15 -P7D 12 STUDYX QS 2324-P0001 12 NSCLC112 NSCLC1-Appetite Domain Subscore NSCLC-SAQ V1.0 0 0 0 Y 1 2015-05-15 -P7D 13 STUDYX QS 2324-P0001 13 NSCLC108 NSCLC1-Total Score NSCLC-SAQ V1.0 7 7 7 Y 1 2015-05-15 -P7D 14 STUDYX QS 2324-P0002 1 NSCLC101 NSCLC1-Rate Coughing at Worst NSCLC-SAQ V1.0 NOT DONE 1 15 STUDYX QS 2324-P0002 2 NSCLC102 NSCLC1-Rate Worst Pain in Chest NSCLC-SAQ V1.0 NOT DONE 1 16 STUDYX QS 2324-P0002 3 NSCLC103 NSCLC1-Rate Worst Pain Other Than Chest NSCLC-SAQ V1.0 NOT DONE 1 ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 26 STUDYX QS 2324-P0002 13 NSCLC108 NSCLC1-Total Score NSCLC-SAQ V1.0 NOT DONE 1

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.

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