You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 19 Next »

Data from QRS instruments are represented in the Functional Tests (FT), Questionnaires (QS), and the Disease Response and Clin Classification (RS) domains. Refer to Section 2.4, About Questionnaires, Ratings, and Scales for information.. 

There are no published CDISC QRS Supplements for the evaluation of sponsor-defined general single-item assessments. These instruments assess symptoms or other disease related items like overall quality of life, etc, and 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). . These assessments may be in the public domain or may be copyrighted. Sponsors are responsible for the appropriate usage of any copyrighted assessments. There may be examples of these assessments in the literature, but they are not considered CDISC QRS instruments for standard development purposes, due to the extreme variability in the methods of capturing these types of assessments.

These general single-item assessments are represented in the Findings About Events or Interventions (FA) domain.

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 VAS used to assess the level of craving (i.e., 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 FA domain was used to represent the assessment of craving. Applicants may represent findings data in a single FA dataset or split the FA domain into separate datasets. In this example, a FACE dataset was used, indicating that data are findings about clinical events. The craving itself is considered a clinical event, whereas craving at specific time points is considered findings about the clinical event. A parent record in the Clinical Events (CE) domain is not required.

Row 1:Shows the craving VAS for subject 001 at baseline
Row 2:

Shows the craving VAS for subject 001 at visit 12.

fa.xpt

face.xpt

RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESNFASTRESUFAMETHODFAEVALVISITNUMFADTCFAEVLINT
1TGI400FA0011SEVSEVERITY/INTENSITYCRAVING

SYMPTOM ASSESSMENT

98mm9898mmVISUAL ANALOG SCALE (100 MM)STUDY SUBJECT1

2015-06-15

-P24H
2

TGI400

FA0012SEVSEVERITY/INTENSITYCRAVINGSYMPTOM ASSESSMENT43mm4343mmVISUAL ANALOG SCALE (100 MM)STUDY SUBJECT122016-07-15-P24H
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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. 

$titleHtml

suppfa.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1TGI400FA001FASEQ1FAANTXLOANCHOR TEXT LOWNO CRAVINGASSIGNED
2TGI400FA001FASEQ1FAANVLLOANCHOR VALUE LOW0ASSIGNED
3TGI400FA001FASEQ1FAANTXHIANCHOR TEXT HIGHSTRONG CRAVINGASSIGNED
3TGI400FA001FASEQ1FAANVLHIANCHOR VALUE HIGH100ASSIGNED
$warningHtml



  • No labels