Revision History
| Date | Version |
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| 2021-12-17 | 1.0 |
© 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) instrument QRSSUPP-268 - Getting issue details... STATUS .
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 instrument is based QRSSUPP-221 - Getting issue details... STATUS on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, QRSSUPP-222 - Getting issue details... STATUS which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.
These specific implementation details for this 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 QRSSUPP-274 - Getting issue details... STATUS 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. QRSSUPP-224 - Getting issue details... STATUS 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.
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 the 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 NSCLC-SAQ V1.0: QRSSUPP-226 - Getting issue details... STATUS
- Patient-Reported Outcome (PRO) Consortium - Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Provisional User Manual, Version 6: March 24, 2017. 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
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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.
QRSSUPP-232 - Getting issue details... STATUS
The NSCLC-SAQ V1.0 is a PRO instrument that assesses key symptoms QRSSUPP-229 - Getting issue details... STATUS of advanced non-small cell lung cancer (NSCLC) over the past 7 days as an endpoint measure in clinical trials. QRSSUPP-230 - Getting issue details... STATUS These concept domains are described in the manual which will be received upon user copyright approval.
Each of the 7 items is rated on a 5-point verbal rating scale QRSSUPP-231 - Getting issue details... STATUS 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.
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 QRSSUPP-233 - Getting issue details... STATUS 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.
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.
If no response is provided for an item, then QSORRES, QSSTRESC, and QSSTRESN are all set to null and QSSTAT = “NOT DONE”.
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. QRSSUPP-234 - Getting issue details... STATUS QRSSUPP-235 - Getting issue details... STATUS These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from user manual.
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. QRSSUPP-236 - Getting issue details... STATUS However, when the subtotal and total scores are received from a central provider or vendor, the value would go into QSORRES and QRSSUPP-237 - Getting issue details... STATUS would be null (See SDTMIG Section: 4.1.8.1, Origin Metadata for Variables).
If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM. QRSSUPP-238 - Getting issue details... STATUS
QRSSUPP-239 - Getting issue details... STATUS
- Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
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 QRSSUPP-240 - Getting issue details... STATUS . Rows 14-26 show the subject was not evaluated on this instrument at visit 1. Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. QRSSUPP-241 - Getting issue details... STATUS Subtotal and total score calculations are referenced in the copyrighted user manual.
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.
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"
| No Coughing at All | 0 | 0 |
| Mild Coughing | 1 | 1 |
| Moderate Coughing | 2 | 2 |
| Severe Coughing | 3 | 3 |
| Very Severe Coughing | 4 | 4 |
QSORRES | QSSTRESC | QSSTRESN |
|---|
QSTESTCD = "NSCLC102" QSTEST = "NSCLC1-Rate Worst Pain in Chest"
QSTESTCD = "NSCLC103" QSTEST = "NSCLC1-Rate Worst Pain Other Than Chest"
| No Pain at All | 0 | 0 |
| Mild Pain | 1 | 1 |
| Moderate Pain | 2 | 2 |
| Severe Pain | 3 | 3 |
| Very Severe Pain | 4 | 4 |
QSORRES | QSSTRESC | QSSTRESN |
|---|
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"
| Never | 0 | 0 |
| Rarely | 1 | 1 |
| Sometimes | 2 | 2 |
| Often | 3 | 3 |
| Always | 4 | 4 |
QSORRES | QSSTRESC | QSSTRESN |
|---|
End of Document
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