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.
© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
This document describes the CDISC implementation of the Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-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 PARENT-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 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 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 PARENT-DDS in the CDISC data standards.
Reference for the Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS):
Hessler D, Fisher L, Polonsky W, Johnson N. Understanding the areas and correlates of diabetes-related distress in parents of teens with type 1 diabetes. Journal of Pediatric Psychology 2016; 41(7): 750-758.
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 PARENT-DDS are listed below.
The PARENT-DDS is a 20-item self-report scale that has 4 dimensions of parent-related distress: personal distress, teen management distress, parent/teen relationship distress, and healthcare team distress. A total scale score and 4 subscale scores are captured.
Respondents respond to each item using a 5-point verbal rating scale from "Not at all" to "A great deal". For the PARENT-DDS, QSORRES is populated with the text description of the rating scale response chosen.
For the PARENT-DDS no score is displayed for any item on the questionnaire; however, the reference article includes the standardized representation of 0 (i.e., "Not at all”) through 4 (i.e., “A great deal"). Because (a) electronic data submission is expected frequently, (b) instructions for scoring are provided in the reference article, 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 PARENT-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 PARENT-DDS is the past 1 month.
The PARENT-DDS instrument includes a total scale score and 4 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 4 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.
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 188.8.131.52, Origin Metadata for Variables).
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 PARENT-DDS QS Domain Model
The PARENT-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 a PARENT-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 PARENT-DDS form. Subscale scores and a total scale score are represented in rows 21-35.
|1||STUDYX||QS||2324-P0001||1||DDS0201||DDS02-Don't Work Well Together||PARENT-DDS||Somewhat||2||2||Y||1||2015-05-15||-P1M|
|2||STUDYX||QS||2324-P0001||2||DDS0202||DDS02-Unappreciated for Ways I Help||PARENT-DDS||A lot||3||3||Y||1||2015-05-15||-P1M|
|3||STUDYX||QS||2324-P0001||3||DDS0203||DDS02-Trust Teen Take Care of Diabetes||PARENT-DDS||Somewhat||2||2||Y||1||2015-05-15||-P1M|
|4||STUDYX||QS||2324-P0001||4||DDS0204||DDS02-Low Blood Sugars Away From Home||PARENT-DDS||A little||1||1||Y||1||2015-05-15||-P1M|
|5||STUDYX||QS||2324-P0001||5||DDS0205||DDS02-Teen Ignore/Forget Diabetes||PARENT-DDS||A little||1||1||Y||1||2015-05-15||-P1M|
|6||STUDYX||QS||2324-P0001||6||DDS0206||DDS02-Taking Too Much of My Energy||PARENT-DDS||Somewhat||2||2||Y||1||2015-05-15||-P1M|
|7||STUDYX||QS||2324-P0001||7||DDS0207||DDS02-Help Teen Is a Battle||PARENT-DDS||A lot||3||3||Y||1||2015-05-15||-P1M|
|8||STUDYX||QS||2324-P0001||8||DDS0208||DDS02-Low Blood Sugars When Sleeping||PARENT-DDS||A little||1||1||Y||1||2015-05-15||-P1M|
DDS02-No One Notices Diabetes Hard on Me
|10||STUDYX||QS||2324-P0001||10||DDS0210||DDS02-Doesn't Do Enough Manage Diabetes||PARENT-DDS||Somewhat||2||2||Y||1||2015-05-15||-P1M|
|11||STUDYX||QS||2324-P0001||11||DDS0211||DDS02-Teen Doesn't Have Right Doctor||PARENT-DDS||Not at all||0||0||Y||1||2015-05-15||-P1M|
|12||STUDYX||QS||2324-P0001||12||DDS0212||DDS02-Blame Me If Not Well-controlled||PARENT-DDS||A little||1||1||Y||1||2015-05-15||-P1M|
|13||STUDYX||QS||2324-P0001||13||DDS0213||DDS02-Leave Home and Cannot Protect Him||PARENT-DDS||A little||1||1||Y||1||2015-05-15||-P1M|
|14||STUDYX||QS||2324-P0001||14||DDS0214||DDS02-Teen Ignores My Suggestions||PARENT-DDS||Somewhat||2||2||Y||1||2015-05-15||-P1M|
|15||STUDYX||QS||2324-P0001||15||DDS0215||DDS02-Lack Support From Friends/Family||PARENT-DDS||Not at all||0||0||Y||1||2015-05-15||-P1M|
|16||STUDYX||QS||2324-P0001||16||DDS0216||DDS02-Doesn't Get Expert Medical Help||PARENT-DDS||Not at all||0||0||Y||1||2015-05-15||-P1M|
|17||STUDYX||QS||2324-P0001||17||DDS0217||DDS02-Motivate Teen Take Care Diabetes||PARENT-DDS||A little||1||1||Y||1||2015-05-15||-P1M|
|18||STUDYX||QS||2324-P0001||18||DDS0218||DDS02-Teen Not Prepared Once Adult||PARENT-DDS||Somewhat||2||2||Y||1||2015-05-15||-P1M|
|19||STUDYX||QS||2324-P0001||19||DDS0219||DDS02-Only One Takes Responsibility||PARENT-DDS||A little||1||1||Y||1||2015-05-15||-P1M|
|20||STUDYX||QS||2324-P0001||20||DDS0220||DDS02-My Nagging Hurting Relationship||PARENT-DDS||A little||1||1||Y||1||2015-05-15||-P1M|
|21||STUDYX||QS||2324-P0001||21||DDS0221||DDS02-Total DDS Score: Sum||PARENT-DDS||27||27||27||Y||1||2015-05-15||-P1M|
|22||STUDYX||QS||2324-P0001||22||DDS0222||DDS02-Total DDS Score: Mean||PARENT-DDS||1.35||1.35||1.35||Y||1||2015-05-15||-P1M|
|23||STUDYX||QS||2324-P0001||23||DDS0223||DDS02-Total DDS Score: Moderate||PARENT-DDS||no||N||Y||1||2015-05-15||-P1M|
|24||STUDYX||QS||2324-P0001||24||DDS0224||DDS02-Personal Distress: Sum||PARENT-DDS||8||8||8||Y||1||2015-05-15||-P1M|
|25||STUDYX||QS||2324-P0001||25||DDS0225||DDS02-Personal Distress: Mean||PARENT-DDS||1.3||1.3||1.3||Y||1||2015-05-15||-P1M|
|26||STUDYX||QS||2324-P0001||26||DDS0226||DDS02-Personal Distress: Moderate||PARENT-DDS||no||N||Y||1||2015-05-15||-P1M|
|27||STUDYX||QS||2324-P0001||27||DDS0227||DDS02-Teen Management Distress: Sum||PARENT-DDS||5||5||5||Y||1||2015-05-15||-P1M|
|28||STUDYX||QS||2324-P0001||28||DDS0228||DDS02-Teen Management Distress: Mean||PARENT-DDS||1.25||1.25||1.25||Y||1||2015-05-15||-P1M|
|29||STUDYX||QS||2324-P0001||29||DDS0229||DDS02-Teen Management Distress: Moderate||PARENT-DDS||no||N||Y||1||2015-05-15||-P1M|
|30||STUDYX||QS||2324-P0001||30||DDS0230||DDS02-Parent/Teen Rel Distress: Sum||PARENT-DDS||14||14||14||Y||1||2015-05-15||-P1M|
|31||STUDYX||QS||2324-P0001||31||DDS0231||DDS02-Parent/Teen Rel Distress: Mean||PARENT-DDS||1.75||1.75||1.75||Y||1||2015-05-15||-P1M|
|32||STUDYX||QS||2324-P0001||32||DDS0232||DDS02-Parent/Teen Rel Distress: Moderate||PARENT-DDS||no||N||Y||1||2015-05-15||-P1M|
|33||STUDYX||QS||2324-P0001||33||DDS0233||DDS02-Healthcare Team Distress: Sum||PARENT-DDS||0||0||0||Y||1||2015-05-15||-P1M|
|34||STUDYX||QS||2324-P0001||34||DDS0234||DDS02-Healthcare Team Distress: Mean||PARENT-DDS||0||0||0||Y||1||2015-05-15||-P1M|
|35||STUDYX||QS||2324-P0001||35||DDS0235||DDS02-Healthcare Team Distress: Moderate||PARENT-DDS||no||N||Y||1||2015-05-15||-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 = "DDS0201" QSTEST = "DDS02-Don't Work Well Together" through
QSTESTCD = "DDS0220" QSTEST = "DDS02-My Nagging Hurting Relationship"
|Not at all||0||0|
|A great deal||4||4|
QSTESTCD = "DDS0223" QSTEST = "DDS02-Total DDS Score: Moderate"
QSTESTCD = "DDS0226" QSTEST = "DDS02-Personal Distress: Moderate"
QSTESTCD = "DDS0229" QSTEST = "DDS02-Teen Management Distress: Moderate"
QSTESTCD = "DDS0232" QSTEST = "DDS02-Parent/Teen Rel Distress: Moderate"
QSTESTCD = "DDS0235" QSTEST = "DDS02-Healthcare Team Distress: Moderate"
End of Document