Guidance for Questionnaires, Ratings, and Scales

Questionnaires, ratings, and scales (QRS) are standardized and often validated instruments. Given this, implementation of collection, tabulation, and analysis standards per this guide is specialized to maintain standardization inherent to instruments and, when applicable, the validity of validated instruments. CDISC provides descriptions for different types of QRS instruments and develops and publishes supplemental guidance for individual QRS instruments when the instrument is in the public domain or when permission has been granted by the copyright holder. CDISC QRS Supplements are maintained as stand-alone guides on the CDISC website at https://www.cdisc.org/foundational/qrs.

The TIG provides general guidance for

QRS Supplements support guidance in the TIG by providing a single source for annotated CRFs, tabulation and analysis dataset content conventions, and examples for QRS instruments. 

The following table lists assessments that are being pursued as potential supplements as part of the development work for this guide. Supplements may or may not be finalized at the time of publication of this guide and depend on copyright approval where applicable. CDISC cannot produce supplements for copyrighted measures without the express permission of the copyright holder. Users of this guide can refer to the QRS page of the CDISC website if a measure of interest is not included in the table, as it may have been developed outside of the scope for this guide; new measures are implemented an ongoing basis by the CDISC QRS Terminology and Standards Development subteams. See CDISC COP 001 at https://www.cdisc.org/about/bylaws for details on implementing or requesting development of CDISC standards.

and the data collected using them are represented in tabulation domains datasets Questionnaires (QS), Disease Response and Clin Classification (RS), and Functional Tests (FT).

See the SDTMIG or the QRS web page (https://www.cdisc.org/foundational/qrs) for complete information on these domains. CDISC publishes supplemental specifications called QRS supplements, including example annotated CRFs (aCRFs) for many of these instruments.

The CDISC QRS web page describes the development methodology for new QRS terminology. Because the nature of QRS precludes implementers from modifying the published data collection structure, the CDASHIG metadata table does not include specifications for QRS. Instead, implementers should refer to instrument-specific QRS supplements on the QRS web page for example aCRFs, instrument-specific assumptions, and data examples.

Assumptions for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain 

1. CDISC standards for QRS include controlled terminology for test codes (--TESTCD), test names (--TEST), standard timing values, standard results for database values, and an aCRF with SDTMIG domain variable names. These standards can be used to create an electronic data collection (EDC) structure following the same conventions that would be used for any Findings class domain. The SDTMIG QS, RS, and FT domains utilize a normalized data structure; that is, 1 variable (--TEST) is used to capture the test name and another variable (--ORRES) is used to capture the result. Even though these domain variables are presented as a normalized structure in the CDASHIG metadata table, implementers using a denormalized structure (1 variable for each test) should create variable names that mirror the values in QRS Controlled Terminology (e.g., QSTESTCD, RSTESTCD, FTTESTCD).
2. Electronic representations of QRS instruments should reflect the title, subheadings, and exact numbering and wording of questions as they appear in original versions.
3. Electronic response fields should allow either the original response (--ORRES) or coded value (--STRESC) to be input—but usually not both, to avoid discrepancies.
4. Checkboxes that appear on validated QRS instruments should remain checkboxes in the CRF/eCRF.
5. Copyrighted instruments may include the copyright notice on the eCRF/CRF. For more copyright Information about QRS instruments, see the QRS web page. 
6. Instrument-specific assumptions are included in the QRS supplements posted on the QRS web page.

Guidance for 

General guidance for use of controlled terminology and formats is provided in this section with detailed instructions provided as part of sections specific to collection, 

Standard conventions for implementation 

Tabulation and analysis standards for questionnaires, ratings, and scales (QRS) are maintained as stand-alone supplemental guides on the CDISC website at https://www.cdisc.org/foundational/qrs.

CDISC QRS Supplements guide implementation of tabulation and analysis standards and should be referred to as supplemental materials to this guide.  

There are no published CDISC QRS Supplements for the evaluation of sponsor-defined general single-item assessments as they are not considered standard QRS instruments, but assess symptoms or other disease related items like overall quality of life, etc. These assessments may be evaluated using sponsor-defined general codelist scales, visual analog scales (VAS) or numeric rating scales (NRS). VAS and NRS Scales use various methods for describing the anchor points and may have descriptor anchors (e.g., beginning, middle and end) for various gradations or numbers). There may be examples of these assessments in the literature, but they are not considered CDISC QRS standard instruments, due to the extreme variability in the methods of capturing these types of assessments. These assessments may be in the public domain or may be copyrighted. Sponsors are responsible for the appropriate usage of any copyrighted assessments. These general single-item assessments are represented in the FA-- domain. 

• The Findings About Events or Interventions (FA–)  is a specialization of the Findings general observation class. As such, it shares all qualities and conventions of Findings observations but is specialized by the addition of the --OBJ variable.

Example

This is an example of a single item visual analog scale (VAS) used to assess the level of craving based on response to the question “ In the past 24 hours, how strong is your craving for cigarettes?” on a scale from “no craving” to “strong craving” by measuring the number of millimeters (0–100 mm) from the “no craving” dot to the point at which the drawn line intersected the scale.

The Findings About Events or Interventions (FA) domain was used to represent the assessment of craving. Sponsors may represent findings data in a single FA dataset or split the FA domain into separate datasets, following the guidance in the guide. In this example, a FACE dataset was used. The craving itself is considered a clinical event, whereas the evaluation of craving at specific time points are considered findings about the clinical event.  A parent record in the CE domain is not required.

This example illustrates how information on the scale scoring may be represented as supplemental qualifier variables. A record in a SUPPFA dataset relates back to the parent record(s) via the key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. Here the parent domain (RDOMAIN) is FA, and IDVAR is FASEQ. QNAM holds the name of the supplemental qualifier variable being defined. 

All QRS questions and reply choices are presented as validated in the CRF to maintain the validity. In some cases, this may result in CRFs that do not conform to CDASH best practices. The use of such questionnaires in their native format should not be considered to affect conformance to CDASH.

All QRS questions and reply choices are presented as validated in the CRF to maintain the validity of a validated instrument. In some cases, this may result in CRFs that do not conform to CDASH best practices; however, restructuring these questionnaires should not be done because it could invalidate them. The use of such questionnaires in their native format should not be considered to affect conformance to CDASH.

Description/Overview for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain

Questionnaires, ratings, and scales (QRS) are standardized and often validated instruments, and the data collected using them are represented in SDTMIG domains including Questionnaires (QS), Disease Response and Clin Classification (RS), and Functional Tests (FT). See the SDTMIG or the QRS web page (https://www.cdisc.org/foundational/qrs) for complete information on these domains. CDISC publishes supplemental specifications called QRS supplements, including example annotated CRFs (aCRFs) for many of these instruments.

The CDISC QRS web page describes the development methodology for new QRS terminology. Because the nature of QRS precludes implementers from modifying the published data collection structure, the CDASHIG metadata table does not include specifications for QRS. Instead, implementers should refer to instrument-specific QRS supplements on the QRS web page for example aCRFs, instrument-specific assumptions, and data examples.

For definitions and descriptions of the different types of questionnaires, ratings, and scales, visit the QRS web page.

The released QRS documentation is maintained on the CDISC QRS web page.

Specification for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain

Reference the QRS supplements posted on the QRS web page and the specifications for specific domains (QS, RS, and FT) in the SDTMIG.

Assumptions for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain 

1. CDISC standards for QRS include controlled terminology for test codes (--TESTCD), test names (--TEST), standard timing values, standard results for database values, and an aCRF with SDTMIG domain variable names. These standards can be used to create an electronic data collection (EDC) structure following the same conventions that would be used for any Findings class domain. The SDTMIG QS, RS, and FT domains utilize a normalized data structure; that is, 1 variable (--TEST) is used to capture the test name and another variable (--ORRES) is used to capture the result. Even though these domain variables are presented as a normalized structure in the CDASHIG metadata table, implementers using a denormalized structure (1 variable for each test) should create variable names that mirror the values in QRS Controlled Terminology (e.g., QSTESTCD, RSTESTCD, FTTESTCD).
2. Electronic representations of QRS instruments should reflect the title, subheadings, and exact numbering and wording of questions as they appear in original versions.
3. Electronic response fields should allow either the original response (--ORRES) or coded value (--STRESC) to be input—but usually not both, to avoid discrepancies.
4. Checkboxes that appear on validated QRS instruments should remain checkboxes in the CRF/eCRF.
5. Copyrighted instruments may include the copyright notice on the eCRF/CRF. For more copyright Information about QRS instruments, see the QRS web page. 
6. Instrument-specific assumptions are included in the QRS supplements posted on the QRS web page.