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Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT)

CDISC ReferenceQuestionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

RAND SOCIAL SUPPORT SURVEY INSTRUMENT QRSSUPP-167 - Getting issue details... STATUS

QRS Permission StatusApproved
TeamPTSD Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2019-06-19
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease reas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical trials.


Revision History

DateVersion
2019-06-191.0 Draft

© 2019 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT) questionnaire.

CDISC does not modify 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 on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found at 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.

The RAND SOCIAL SUPPORT SURVEY INSTRUMENT is reproduced here with permission from the RAND Corporation. Copyright © the RAND Corporation. RAND's permission to reproduce the survey is not an endorsement of the products, services, or other uses in which the survey appears or is applied.

2 Copyright Status

The RAND Corporation owns the copyright for the RAND SOCIAL SUPPORT SURVEY INSTRUMENT and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the questionnaire. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

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 (RAND SOCIAL SUPPORT SURVEY INSTRUMENT Annotated CRF).

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 (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 licenses fees charged by the copyright holder.

CDISC acknowledges the RAND Corporation for the approval to include the RAND SOCIAL SUPPORT SURVEY INSTRUMENT in the CDISC data standards.

Reference for the RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT):

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 RAND SOCIAL SUPPORT SURVEY INSTRUMENT are listed below.

The RAND SOCIAL SUPPORT SURVEY INSTRUMENT is a multiple-choice questionnaire that may be used to assess the amount and types of social support available to a patient. It consists of 19 items, each rated on a 5-point scale.

  1. The scale points include a numeric rating (1-5) and a definition of what is represented by the rating (e.g., 1 = "None of the time"). For the RAND SOCIAL SUPPORT SURVEY INSTRUMENT, QSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

  2. Items on the RAND SOCIAL SUPPORT SURVEY INSTRUMENT are divided into subcategories by the type of support (i.e., "EMOTIONAL/INFORMATIONAL SUPPORT", "TANGIBLE SUPPORT", "AFFECTIONATE SUPPORT", "POSITIVE SOCIAL INTERACTION"), stored in QSSCAT, plus 1 additional item (QSSCAT = "ADDITIONAL ITEM")

  3. Terminology
    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier and result fields is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the RAND SOCIAL SUPPORT SURVEY INSTRUMENT QS Domain Model

The RAND SOCIAL SUPPORT SURVEY INSTRUMENT 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 the RAND SOCIAL SUPPORT SURVEY 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.

We are unable to make the example blue because of errors that would be created in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.


The table represents the questions from the RAND SOCIAL SUPPORT SURVEY INSTRUMENT form.

 qs.xpt

qs.xpt

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSSCATQSORRESQSSTRESCQSSTRESNQSLOBXFLVISITNUMQSDTC
1STUDYXQS2324-P00011RSSS0101RSSS01-Count on to Listen to YouRAND SOCIAL SUPPORT SURVEY INSTRUMENTEMOTIONAL/INFORMATIONAL SUPPORTMost of the time44Y12015-05-15
2STUDYXQS2324-P00022RSSS0102RSSS01-Give You Info to Help UnderstandRAND SOCIAL SUPPORT SURVEY INSTRUMENTEMOTIONAL/INFORMATIONAL SUPPORTSome of the time33Y12015-05-15
3STUDYXQS2324-P00033RSSS0103RSSS01-Give You Advice About a CrisisRAND SOCIAL SUPPORT SURVEY INSTRUMENTEMOTIONAL/INFORMATIONAL SUPPORTMost of the time44Y12015-05-15
4STUDYXQS2324-P00044RSSS0104RSSS01-Confide in/Talk to About YourselfRAND SOCIAL SUPPORT SURVEY INSTRUMENTEMOTIONAL/INFORMATIONAL SUPPORTSome of the time33Y12015-05-15
5STUDYXQS2324-P00055RSSS0105RSSS01-Advice You Really WantRAND SOCIAL SUPPORT SURVEY INSTRUMENTEMOTIONAL/INFORMATIONAL SUPPORTSome of the time33Y12015-05-15
6STUDYXQS2324-P00066RSSS0106RSSS01-Share Your Private Worries/FearsRAND SOCIAL SUPPORT SURVEY INSTRUMENTEMOTIONAL/INFORMATIONAL SUPPORTMost of the time44Y12015-05-15
7STUDYXQS2324-P00077RSSS0107RSSS01-Turn to Suggestions Personal ProbRAND SOCIAL SUPPORT SURVEY INSTRUMENTEMOTIONAL/INFORMATIONAL SUPPORTMost of the time44Y12015-05-15
8STUDYXQS2324-P00088RSSS0108RSSS01-Understands Your ProblemsRAND SOCIAL SUPPORT SURVEY INSTRUMENTEMOTIONAL/INFORMATIONAL SUPPORTSome of the time33Y12015-05-15
9STUDYXQS2324-P00099RSSS0109RSSS01-Help If You Were Confined to BedRAND SOCIAL SUPPORT SURVEY INSTRUMENTTANGIBLE SUPPORTSome of the time33Y12015-05-15
10STUDYXQS2324-P001010RSSS0110RSSS01-Take You to the Doctor If NeededRAND SOCIAL SUPPORT SURVEY INSTRUMENTTANGIBLE SUPPORTSome of the time33Y12015-05-15
11STUDYXQS2324-P001111RSSS0111RSSS01-Prepare Your Meals If UnableRAND SOCIAL SUPPORT SURVEY INSTRUMENTTANGIBLE SUPPORTMost of the time44Y12015-05-15
12STUDYXQS2324-P001212RSSS0112RSSS01-Help With Daily Chores If SickRAND SOCIAL SUPPORT SURVEY INSTRUMENTTANGIBLE SUPPORTSome of the time33Y12015-05-15
13STUDYXQS2324-P001313RSSS0113RSSS01-Shows You Love and AffectionRAND SOCIAL SUPPORT SURVEY INSTRUMENTAFFECTIONATE SUPPORTMost of the time44Y12015-05-15
14STUDYXQS2324-P001414RSSS0114RSSS01-Love and Make You Feel WantedRAND SOCIAL SUPPORT SURVEY INSTRUMENTAFFECTIONATE SUPPORTAll of the time55Y12015-05-15
15STUDYXQS2324-P001515RSSS0115RSSS01-Hugs YouRAND SOCIAL SUPPORT SURVEY INSTRUMENTAFFECTIONATE SUPPORTMost of the time44Y12015-05-15
16STUDYXQS2324-P001616RSSS0116RSSS01-Have a Good Time WithRAND SOCIAL SUPPORT SURVEY INSTRUMENTPOSITIVE SOCIAL INTERACTIONMost of the time44Y12015-05-15
17STUDYXQS2324-P001717RSSS0117RSSS01-Get Together With for RelaxationRAND SOCIAL SUPPORT SURVEY INSTRUMENTPOSITIVE SOCIAL INTERACTIONSome of the time33Y12015-05-15
18STUDYXQS2324-P001818RSSS0118RSSS01-Do Something Enjoyable WithRAND SOCIAL SUPPORT SURVEY INSTRUMENTPOSITIVE SOCIAL INTERACTIONSome of the time33Y12015-05-15
19STUDYXQS2324-P001919RSSS0119RSSS01-Help You Get Your Mind Off ThingsRAND SOCIAL SUPPORT SURVEY INSTRUMENTADDITIONAL ITEMMost of the time44Y12015-05-15

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.

As stated in Section 3.1, Assumptions, items on the RAND SOCIAL SUPPORT SURVEY INSTRUMENT are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

QSSCAT alignment with QSTESTCD

QSSCAT

QSTESTCD

EMOTIONAL/INFORMATIONAL SUPPORTRSSS0101 - RSSS0108
TANGIBLE SUPPORTRSSS0109 - RSSS0112
AFFECTIONATE SUPPORTRSSS0113 - RSSS0115
POSITIVE SOCIAL INTERACTIONRSSS0116 - RSSS0118
ADDITIONAL ITEMRSSS0119


"ALL QSTESTCDs" QRSSUPP-168 - Getting issue details... STATUS

None of the time11
A little of the time22
Some of the time33
Most of the time44
All of the time55

QSORRES

QSSTRESC

QSSTRESN

End of Document

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