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© 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) questionnaire.  

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 is based QRSSUPP-221 - Getting issue details... STATUS on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain mode QRSSUPP-222 - Getting issue details... STATUS l, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this questionnaire 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.

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.  QRSSUPP-224 - Getting issue details... STATUS

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.

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 Path Institute for approval QRSSUPP-225 - Getting issue details... STATUS 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): QRSSUPP-226 - Getting issue details... STATUS  

• QRSSUPP-227 - Getting issue details... STATUS
• 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 QRSSUPP-228 - Getting issue details... STATUS 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.

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.

QSTESTCD = "NSCLC101" QSTEST = "NSCLC1-Rate Coughing at Worst"

QSTESTCD = "NSCLC102" QSTEST = "NSCLC1-Rate Worst Pain in Chest"

QSTESTCD = "NSCLC103" QSTEST = "NSCLC1-Rate Worst Pain Other Than Chest"

QSTESTCD = "NSCLC104" QSTEST = "NSCLC1-Short of Breath Usual Activities"

QSTESTCD = "NSCLC105" QSTEST = "NSCLC1-How Often Low Energy"

QSTESTCD = "NSCLC106" QSTEST = "NSCLC1-How Often Tire Easily"

QSTESTCD = "NSCLC107" QSTEST = "NSCLC1-How Often Poor Appetite"

End of Document