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Revision History

© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Children's Depression Rating Scale, Revised (CDRS-R) instrument.

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These specific implementation details for this instrument 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/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC web site 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. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

Western Psychological Services (WPS) owns the copyright for the CDRS-R instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. WPS will distribute the CDISC supplement package to sponsors when they are approved to use this instrument. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument.

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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 license fees charged by the copyright holder.

CDISC acknowledges WPS for the approval to include the CDRS-R in the CDISC data standards.

Reference for the (CDRS CDRS-R):

• Children's Depression Rating Scale, Revised (CDRS-R). Copyright 1995 by WESTERN PSYCHOLOGICAL SERVICES. Not to be reproduced in whole or in part without written permission. All rights reserved.

• Children's Depression Rating Scale, Revised (CDRS-R) Manual, Elva O. Poznanski, M.D. and Hartmut B. Mokros, Ph.D., Copyright 1996 Western Psychological Services, All rights reserved.

• More information on the CDRS-R can be found on the WPS website at:https://www.wpspublish.com/store/p/2703/cdrs-r-childrens-depression-rating-scale-revised.

3 The RS Domain Model

3.1 Assumptions for RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the CDRS-R are listed below.

The CDRS-R is a instrument used for evaluating depression in children. It consists of 17 items, rated on either a 5- or 7-point rating scale. There are also 3 subtotals, a raw summary score ranging from 17-113, a T-Score, a percentile, and a categorical T-Score range, which are all considered as captured data on the CDRS-R. Separate interviews with a child and parent and/or other adult are suggested to be conducted. At the conclusion of the interviews, a "Best Description of Child" is rated by the properly trained rater.

1. The 17 scale points include a numeric rating (1-5 or 1-7) and a definition of what is represented by various ratings of either 1, 3, 5, or 7 (e.g., 1 = "Performance is consistent with ability", 3 = "Decrease in school performance and/or ability to concentrate", etc.). Not all scores in the rating of each symptom have a definition. For the CDRS-R, RSORRES is populated with the text description when it exists and is represented by the numeric value when there is no corresponding definition, while whereas only the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
   

   1. According to the CDRS-R manual, if a particular symptom area cannot be assigned a numeric rating on the basis of existing information, then the abbreviation "NR" (RSORRES = "Not Rated", RSSTRESC = "NR") should be written in the box where a rating is expected.

2. The RSSCAT variable represents the "Comparison of Symptom Ratings from All Sources" section on page 1 of the CRF. The RSSCAT response set includes "CHILD", "MOTHER", "FATHER", "COMBINED PARENTS", "PARENT", and "OTHER". Also included in RSSCAT is the "BEST DESCRIPTION OF CHILD" from this same section, which the examiner rates based on all of the interviewees' responses. 
   

3. The CDRS-R instrument includes 3 subtotals, a raw summary score (17-113), a T-Score, a percentile rank, and a categorical T-Score range that are collected on the CRF and considered as captured data on the CRF and is not considered as derived in the example below.
    These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from the user manual.
   

   1. These subtotals and summary results These subtotals and summary results are only captured on the child interview. Individual symptom scores can be compared between all interviewees on the first page of the Administration Booklet (i.e., CRF), in the section " Comparison of Symptom Ratings from All Sources "section.
   2. The Percentile percentile rank, T-Score, and T-Score range are obtained from the "scoring thermometer" and the " Interpretation of the CDRS-R T-Score " sections located section on the first page of the Administration Booklet. These results cannot be operationally derived.
   3. 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 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. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
4. If the interview was conducted by a parent or other adult, they stop rating the symptoms after symptom 14. Symptoms 15, 16, and 17, along with the raw summary score, T-Score, percentile rank, and categorical T-Score range are also not represented based on Chapter 3 of the user CDRS-R manual describing interpretative considerations.

5. Representation of printed admistrative information

   1. The CRF preprinted "Examiner" (i.e., administrator performing the evaluation) is represented in SUPPRS with the QNAM = “RSPPRADM” and QLABEL = “Preprinted Administrator”. The collected examiner name or initials is represented is presented in SUPPRS with the QNAM = “RSCOLAVL” and QLABEL = “Collected Administrator Value”. For the

   The evaluator is stored in RSEVAL. For CDRS-R, the evaluator is defined as the "EXAMINER". Alternatively, if only evaluator name or initials could be collected: For 

   1. CDRS-R, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator.

   CDISC Controlled Terminology is available for Evaluator (e.g., --EVAL = "HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., --EVALID = "RATER 1").

   1.  

      1. The CDRS-R manual defines the examiner as a
   The CDRS-R manual defines the examiner as a
   1. 1. properly trained professional, including psychiatric clinicians, family practitioner, social workers, pediatricians, school psychiatrists, and school nurses.
    The
   1. The CRF preprinted "Interviewee" (i.e., respondent providing the evaluation) is represented in SUPPRS with the QNAM = “RSPPRRES” and QLABEL = “Preprinted Respondent”. The set of individual
   Interviewee values displayed
   1. “Interviewee” responses listed on page 1 of the CRF are represented with a nonstandard variable QNAM = "
   RSINTRV"
   1. RSCOLRVL" and QLABEL = “Collected Respondent Value” in SUPPRS related to the RSSCAT variable. The QVAL responses include "CHILD", "MOTHER", "FATHER", "COMBINED PARENTS", and "OTHER". A new value of "
   combined parents
   1. COMBINED PARENTS" interview was added to indicate the parents conducted the interview together.
   The
   1. The "Other (specify):" item on the CRF is represented with the collected interviewee value that was written on the line represented with variable QNAM = "
   RSOTHSPC".
   1. RSOTHRSP" and QLABEL = "Other Respondent specify".
6. Some responses to the CDRS-R symptoms exceeded the 200-character limit for the RSORRES variable and needed to be reduced to 200 or less characters. Section 4, SDTM Mapping Strategy indicates which symptom responses were revised in order to fit the 200-character limit.

7. Terminology:

   1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

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

3.2 Example for the Disease Response and Clin Classification Domain Model

The following CDRS-R example below shows the terminology used to implement the measure in the RS domain. This example shows the data for 1 subject collected by the "CHILD",   "MOTHER", and "OTHER" interviews at the baseline visit for a CDRS-R measure. The "BEST DESCRIPTION OF CHILD" category is also represented. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES and RSSTRESC. 

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The table represents the symptoms the items from the CDRS-R instrument. USUBJID = "2324-P0001" includes the items from the CDRS-R instrument for the three 3 interviews plus the "Best Description of Child" that are distinguished by values in the variable RSSCAT. Actual comments for the 17 symptoms are represented with values of "Comment text" in the example. If a comment was not made, it would not be represented in the dataset. The "MOTHER", "OTHER", and "BEST DESCRIPTION OF CHILD" interview symptoms are abbreviated to show the range of symptoms for those interviews in order to maintain a manageable example.

The interviewees question at the top of the CRF is a more detailed representation of the interviewees listed in the "Comparison of Symptom Ratings from All Sources" section on page 1 of the CRF. This is represented with the QNAM = "RSTINRV". The Other specify interview is represented in SUPPRS with the QNAM = "RSOTHSPC", QLABEL = "Other specify" and QVAL = "TEACHER" in this example. The "When Sleep Disturbance Occurs"  in QSTESTCD = "CDRS104", three SUPPRS variables are needed to indicate the "all that apply" results with QNAM = " RSSLPDS1"," RSSLPDS2", and" RSSLPDS3". The "Type of Appetite Disturbance"  is also a non-standard variable related to QSTESTCD = "CDRS105" and represented in SUPPRS with QNAM = "RSAPPDST" respectively.

The CRF preprinted "Examiner" (i.e., administrator performing the evaluation) and preprinted " Interviewee” (i.e., respondent providing responses) are represented in SUPPRS. The collected interviewees listed at the top of the CRF are a more detailed representation of the interviewees listed in the Comparison of Symptom Ratings from All Sources section on page 1 of the CRF. This is represented with the QNAM = "RSPPRRES". The "Other (specify):" interviewee is represented in SUPPRS with the QNAM = "RSOTHRSP", QLABEL = "Other Respondent specify" and QVAL = "TEACHER" in this example. The "When Sleep Disturbance Occurs" in RSTESTCD = "CDRS104", 3 SUPPRS variables are needed to indicate the "all that apply" results with QNAM = " RSSLPDS1"," RSSLPDS2", and" RSSLPDS3". The "Type of Appetite Disturbance" is also a non-standard variable related to RSTESTCD = "CDRS105" and represented in SUPPRS with QNAM = "RSAPPDST", respectively.

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 RS domain. It also provides guidance on how the result variables (RSORRES and RSSTRESC) should be populated.

Some of the responses for RSTESTCD = “CDRS102”, “CDRS115”, and “CDRS116” exceeded the 200-character original response limit. These responses were shortened to fit within the 200-character limit. For theses these RSTESTCDs in the table below, the CRF Response column labeled “CRF Response” represents the original response from the CRF that is over 200 characters. The RSORRES column represents the truncated response.

RSTESTCD = "CDRS101"    RSTEST = "CDRS1-Impaired Schoolwork"

RSTESTCD = "CDRS102"    RSTEST = "CDRS1-Difficulty Having Fun"

RSTESTCD = "CDRS103"    RSTEST = "CDRS1-Social Withdrawal"

RSTESTCD = "CDRS104"    RSTEST = "CDRS1-Sleep Disturbance"

RSTESTCD = "CDRS105"    RSTEST = "CDRS1-Appetite Disturbance"

RSTESTCD = "CDRS106"    RSTEST = "CDRS1-Excessive Fatigue"

RSTESTCD = "CDRS107"    RSTEST = "CDRS1-Physical Complaints"

RSTESTCD = "CDRS108"    RSTEST = "CDRS1-Irritability"

RSTESTCD = "CDRS109"    RSTEST = "CDRS1-Excessive Guilt"

RSTESTCD = "CDRS110"    RSTEST = "CDRS1-Low Self-esteem"

RSTESTCD = "CDRS111"    RSTEST = "CDRS1-Depressed Feelings"

RSTESTCD = "CDRS112"    RSTEST = "CDRS1-Morbid Ideation"

RSTESTCD = "CDRS113"    RSTEST = "CDRS1-Suicidal Ideation"

RSTESTCD = "CDRS114"    RSTEST = "CDRS1-Excessive Weeping"

RSTESTCD = "CDRS115"    RSTEST = "CDRS1-Depressed Facial Affect"

RSTESTCD = "CDRS116"    RSTEST = "CDRS1-Listless Speech"

RSTESTCD = "CDRS117"    RSTEST = "CDRS1-Hypoactivity"

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5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the CDRS-R Supplement Qualifiers for Clinical Classifications (SUPPRS) special purpose dataset.

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