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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

Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)

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

T1-DDS

QRS Permission StatusApproved
TeamType 1 Diabetes Standards team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2020-03-25
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


Revision History

DateVersion
2020-03-25
1.0 Draft

© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) 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 on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, 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.

2 Copyright Status

Behavioral Diabetes Institute owns the copyright for the T1-DDS instrument and has granted CDISC permission to include this supplement in the CDISC collection 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.

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated

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 Behavioral Diabetes Institute for the approval to include the T1-DDS in the CDISC data standards.

Reference for the Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS):

Fisher L, Polonsky WH, Hessler DM, Masharani U, Blumer I, Peters AL, Strycker LA, Bowyer V. Understanding the sources of diabetes distress in adults with type 1 diabetes. J Diabetes Complications 2015; 29(4): 572-7.

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 T1-DDS are listed below.

The T1-DDS is a 28-item self-report scale that highlights 7 critical dimensions of distress: powerlessness, management distress, hypoglycemia distress, negative social perceptions, eating distress, physician distress, and friend/family distress. A total scale score and 7 subscale scores are also captured.

  1. The scale points include a numeric rating (1-6) and a definition of what is represented by the rating (e.g., 1 = "Not a problem"). For the T1-DDS, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

  2. The time period of evaluation for the T1-DDS 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 T1-DDS is the past 1 month.

  3. The T1-DDS instrument includes a total scale score and 7 subscale scores that are considered as captured data on the CRF and are not considered as derived in the example below. The total scale score and 7 subscale scores are considered as captured data when provided as part of Electronic Data Transfer (eDT) 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 --ORRES and --DRVFL would be null (See SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

  4. 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 T1-DDS QS Domain Model

The T1-DDS 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 T1-DDS 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 consistently show blue 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 items from the T1-DDS form. Subscale scores and a total scale score are represented in rows 29-36.

 qs.xpt

qs.xpt

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011DDS0101DDS01-Not Skilled at Managing DiabetesT1-DDSA slight problem22Y12015-05-15-P1M
2STUDYXQS2324-P00012DDS0102DDS01-I Don't Eat Carefully as I ShouldT1-DDSA moderate problem33Y12015-05-15-P1M
3STUDYXQS2324-P00013DDS0103DDS01-Don't Notice Signs of HypoglycemiaT1-DDSA slight problem22Y12015-05-15-P1M
4STUDYXQS2324-P00014DDS0104DDS01-People Treat Me DifferentlyT1-DDSNot a problem11Y12015-05-15-P1M
5STUDYXQS2324-P00015DDS0105DDS01-Discouraged See High Blood GlucoseT1-DDSA moderate problem33Y12015-05-15-P1M
6STUDYXQS2324-P00016DDS0106DDS01-Family Make Bigger Deal DiabetesT1-DDSA slight problem22Y12015-05-15-P1M
7STUDYXQS2324-P00017DDS0107DDS01-Can't Tell Doctor What on My MindT1-DDSA slight problem22Y12015-05-15-P1M
8STUDYXQS2324-P00018DDS0108DDS01-Not Taking Insulin as I ShouldT1-DDSNot a problem11Y12015-05-15-P1M
9STUDYXQS2324-P00019DDS0109

DDS01-Too Much Diabetes Equipment w/Me

T1-DDSA slight problem22Y12015-05-15-P1M
10STUDYXQS2324-P000110DDS0110DDS01-Have to Hide My DiabetesT1-DDSNot a problem11Y12015-05-15-P1M
11STUDYXQS2324-P000111DDS0111DDS01-Family Worry About HypoglycemsiaT1-DDSA moderate problem33Y12015-05-15-P1M
12STUDYXQS2324-P000112DDS0112DDS01-Don't Check Glucose as I ShouldT1-DDSA slight problem22Y12015-05-15-P1M
13STUDYXQS2324-P000113DDS0113DDS01-Worried Develop ComplicationsT1-DDSNot a problem11Y12015-05-15-P1M
14STUDYXQS2324-P000114DDS0114DDS01-Don't Get Help From DoctorT1-DDSNot a problem11Y12015-05-15-P1M
15STUDYXQS2324-P000115DDS0115DDS01-Hypoglycemic Event When AsleepT1-DDSA slight problem22Y12015-05-15-P1M
16STUDYXQS2324-P000116DDS0116DDS01-Food and Eating Control My LifeT1-DDSA moderate problem33Y12015-05-15-P1M
17STUDYXQS2324-P000117DDS0117DDS01-Family Treat Me More FragileT1-DDSA slight problem22Y12015-05-15-P1M
18STUDYXQS2324-P000118DDS0118DDS01-Doctor Doesn't UnderstandT1-DDSNot a problem11Y12015-05-15-P1M
19STUDYXQS2324-P000119DDS0119DDS01-Less Attractive to EmployersT1-DDSA slight problem22Y12015-05-15-P1M
20STUDYXQS2324-P000120DDS0120DDS01-Family Act Like Diabetes PoliceT1-DDSA slight problem22Y12015-05-15-P1M
21STUDYXQS2324-P000121DDS0121DDS01-Be Perfect w/Diabetes ManagementT1-DDSA somewhat serious problem44Y12015-05-15-P1M
22STUDYXQS2324-P000122DDS0122DDS01-Hypoglycemic Event While DrivingT1-DDSA slight problem22Y12015-05-15-P1M
23STUDYXQS2324-P000123DDS0123DDS01-Eating Is Out of ControlT1-DDSA slight problem22Y12015-05-15-P1M
24STUDYXQS2324-P000124DDS0124DDS01-People Think Less of MeT1-DDSNot a problem11Y12015-05-15-P1M
25STUDYXQS2324-P000125DDS0125DDS01-Never Be Good EnoughT1-DDSA somewhat serious problem44Y12015-05-15-P1M
26STUDYXQS2324-P000126DDS0126DDS01-Doctor Doesn't Know EnoughT1-DDSNot a problem11Y12015-05-15-P1M
27STUDYXQS2324-P000127DDS0127DDS01-Be Safe From Hypoglycemic EventT1-DDSA slight problem22Y12015-05-15-P1M
28STUDYXQS2324-P000128DDS0128DDS01-Don't Give Diabetes AttentionT1-DDSA moderate problem33Y12015-05-15-P1M
29STUDYXQS2324-P000129DDS0129DDS01-Total ScaleT1-DDS2.042.042.04Y12015-05-15-P1M
30STUDYXQS2324-P000130DDS0130DDS01-Subscale 1: PowerlessnessT1-DDS2.82.82.8Y12015-05-15-P1M
31STUDYXQS2324-P000131DDS0131DDS01-Subscale 2: Management DistressT1-DDS222Y12015-05-15-P1M
32STUDYXQS2324-P000132DDS0132DDS01-Subscale 3: Hypoglycemia DistressT1-DDS222Y12015-05-15-P1M
33STUDYXQS2324-P000133DDS0133DDS01-Subscale 4: Neg Social PerceptionsT1-DDS1.251.251.25Y12015-05-15-P1M
34STUDYXQS2324-P000134DDS0134DDS01-Subscale 5: Eating DistressT1-DDS2.672.672.67Y12015-05-15-P1M
35STUDYXQS2324-P000135DDS0135DDS01-Subscale 6: Physician DistressT1-DDS1.251.251.25Y12015-05-15-P1M
36STUDYXQS2324-P000136DDS0136DDS01-Subscale 7: Friend/Family DistressT1-DDS2.252.252.25Y12015-05-15-P1M

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 = "DDS0101" QSTEST = "DDS01-Not Skilled at Managing Diabetes" through

QSTESTCD = "DDS0128" QSTEST = "DDS01-Don't Give Diabetes Attention"

QSORRESQSSTRESCQSSTRESN
Not a problem
11
A slight problem
22
A moderate problem
33
A somewhat serious problem
44
A serious problem55
A very serious problem66



End of Document

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