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  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 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.

    1. 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 in the section "Comparison of Symptom Ratings from All Sources".
    2. The 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 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 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 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 CDRS-R, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. 

      1. The CDRS-R manual defines the examiner as a properly trained professional, including psychiatric clinicians, family practitioner, social workers, pediatricians, school psychiatrists, and school nurses.
    2. The CRF preprinted "Interviewee" (i.e., resondent providing the evaluation) is represented in SUPPRS with the QNAM = “RSPPRRES” and QLABEL = “Preprinted Respondent”. The set of individual “Interviewee” responses listed on page 1 of the CRF are represented with a nonstandard variable QNAM = "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" interview was added to indicate the parents conducted the interview together. The "Other (specify):" item on the CRF is represented with the collected interviewee value that was written on the line represented with variable QNAM = "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. list of value sets for the qualifier and result field is provided in Section 4, SDTM Mapping Strategy.

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The 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 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", three SUPPRS variables are needed to indicate the "all that apply" results with QNAM = RSSLPDS1",RSSLPDS2", andRSSLPDS3". The "Type of Appetite Disturbance"   is also a non-standard variable related to RSTESTCD = "CDRS105" and represented in SUPPRS with QNAM = "RSAPPDST" respectively.

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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 RSTESTCDs in the table below, the 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"

RSORRES

RSSTRESC

RSSTRESN

Performance is consistent with ability

1

1

 2

2

2

Decrease in school performance and/or ability to concentrate

3

3

4

4

Major interference with performance in most studies

5

5

6

6

No motivation to perform

7

7


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

CRF Response

RSORRES

RSSTRESC

RSSTRESN

Interest and activities realistically appropriate for age, personality, and social environment. No appreciable change from usual behavior during at least the past 2 weeks. Any feelings of boredom are seen as transient.

Interest and activities realistically appropriate for age, personality, and social environment. No appreciable change from usual behavior during at least the past 2 weeks.

1

1

 

 2

2

2

 

Describes some activities as enjoyable that are realistically available several times a week but not on a daily basis. Shows interest but not enthusiasm.

3

3

 

 4

4

4

Is easily bored. Complains of “nothing to do” as characteristic of daily experience. Participates in structured activities with a “going through the motions” attitude. May express interest primarily in activities that are (realistically) unavailable on a daily or weekly basis.

Is easily bored. Complains of “nothing to do” as characteristic of daily experience. Participates in structured activities with a “going through the motions” attitude.

5

5

 

 6

6

6

Has no initiative to become involved in any activities. Describes himself/herself as primarily passive. Watches others play or watches TV but shows little interest. Requires coaxing and/or pushing to get involved in activity. Shows no enthusiasm or real interest. Has difficulty naming activities.

Has no initiative to become involved in any activities. Describes himself/herself as primarily passive. Watches others play or watches TV but shows little interest.

7

7


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

RSORRES

RSSTRESC

RSSTRESN

 Enjoys friendship with peers at school and at home.

1

1

 2

2

2

Does not actively seek out friendships but waits instead for others to initiate a relationship. Occasionally rejects opportunities to play, without having a describable alternative.

3

3

 4

4

4

Frequently avoids or refuses opportunities for desirable interaction with others and/or sets up situations where rejection is inevitable.

5

5

 6

6

6

Does not currently relate to other children. States that he/she has “no friends” or actively rejects new or former friends.

7

7


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

RSORRES

RSSTRESC

RSSTRESN

No difficulty or occasional difficulty that is situationally explainable11
222
Frequently has mild difficulty with sleep33
444
Has difficulty with sleep nearly every night55


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

RSORRES

RSSTRESC

RSSTRESN

No problems or changes in eating pattern

1

1

 2

2

2

 Mild but notable change from usual eating habits

3

3

 4

4

4

Avoids eating and/or is not hungry most of the time OR describes a noteworthy increase in appetite and/or excessive food intake

5

5


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

RSORRES

RSSTRESC

RSSTRESN

No unusual complaints of “feeling tired” during the day

1

1

 2

2

2

Complaints of fatigue seen somewhat excessive and are not related to boredom or increased activity levels

3

3

 4

4

4

Daily complaints of feeling tired

5

5

 6

6

6

Complains of feeling tired most of the day. May voluntarily take long naps without feeling refreshed. Degree of fatigue interferes with play activities.

7

7


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

RSORRES

RSSTRESC

RSSTRESN

Occasional complaints that do not appear to be excessive

1

1

 2

2

2

Complaints appear mildly excessive

3

3

 4

4

4

Complains daily of aches and pains. These occasionally interfere with his/her ability to function

5

5

 6

6

6

Preoccupied with aches and pains. These regularly interfere with play activities.

7

7


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

RSORRES

RSSTRESC

RSSTRESN

Rarely irritable

1

1

 2

2

2

Easily irritable. Periods of irritability occur several times a week, but do not last long.

3

3

 4

4

4

Frequently irritable. Extended periods of irritability occur several times a week and are difficult to break out of.

5

5

 6

6

6

Constant experience of irritability. Nothing changes this mood.

7

7


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

RSORRES

RSSTRESC

RSSTRESN

Does not express any undue feeling of guilt. Reported guilt appears appropriate to precipitating event.

1

1

 2

2

2

Exaggerates guilt and/or shame out of proportion to the event described.

3

3

 4

4

4

Feels guilt over things not under his/her control. These feelings interfere with everyday functioning.

5

5

 6

6

6

Severe delusions of guilt.

7

7


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

RSORRES

RSSTRESC

RSSTRESN

Describes himself/herself in primarily positive terms

1

1

 2

2

2

Describes one important or prominent area where he/she feels there is a deficit

3

3

 4

4

4

Describes himself/herself in predominantly negative terms or gives bland answers to questions asked

5

5

 6

6

6

Refers to himself/herself in derogatory terms. Reports that other children frequently refer to him/her by using derogatory nicknames. Puts himself/herself down.

7

7


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

RSORRES

RSSTRESC

RSSTRESN

Occasional feelings of unhappiness that quickly disappear

1

1

 2

2

2

Describes sustained periods of unhappiness that appear excessive for events described

3

3

 4

4

4

Feels unhappy most of the time without a major precipitating cause

5

5

 6

6

6

Feels unhappy all of the time; characterized by a sense of psychic pain (e.g., "I can't stand it")

7

7


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

RSORRES

RSSTRESC

RSSTRESN

No morbid thinking reported

1

1

Strongly denies morbid thoughts

2

2

Discusses morbid thoughts that relate to a real event but seem excessive

3

3

 4

4

4

Describes preoccupation with morbid thoughts several times a week. These morbid thoughts extend beyond external reality.

5

5

 6

6

6

Preoccupied on a daily basis with death themes or morbid thoughts that are elaborate, extensive, or bizarre

7

7


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

RSORRES

RSSTRESC

RSSTRESN

Understands the word suicide, but does not apply the term to himself/herself

1

1

Sharp denial of suicidal thoughts

2

2

Has thoughts about suicide, or of hurting himself/herself (if he/she does not understand the concept of suicide), usually when angry

3

3

 4

4

4

Has recurrent thoughts of suicide

5

5

 6

6

6

Has made a suicide attempt within the last month or is actively suicidal

7

7


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

RSORRES

RSSTRESC

RSSTRESN

Report appears normal for age

1

1

Suggestive statements that he/she cries, or feels like crying, more frequently than peers

2

2

Cries more often than peers, occasionally without clear precipitant

3

3

 4

4

4

Cried or feels like crying frequently (several times a week). Admits to crying without knowing the reason why.

5

5

 6

6

6

Cries nearly every day

7

7


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

CRF Response

RSORRES

RSSTRESC

RSSTRESN

 

Facial expression and voice animated during the interview. No sign of depressed affect.

1

1

 

Mild suppression of affect. Some loss of spontaneity.

2

2

Overall loss of spontaneity. Looks unhappy during parts of the interview (e.g., sullen face, lowered eyes, lack of animation in face). Is capable of smiling, however, and does not avoid eye contact when discussing nonthreatening areas.

Overall loss of spontaneity. Looks unhappy during parts of the interview (e.g., sullen face, lowered eyes, lack of animation in face).

3

3

 

 4

4

4

 

Moderate restriction of affect throughout most of the interview. Has long and frequent periods of looking distinctly unhappy. Nothing seems to enliven him/her.

5

5

 

 6

6

6

 

Severe restriction of affect. Looks distinctly sad and withdrawn. Minimal verbal interaction throughout the interview. Cries or may appear tearful.

7

7


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

CRF Response

RSORRES

RSSTRESC

RSSTRESN

 

Quality of speech seems situationally sensitive without any noteworthy deviations

1

1

 

Slowed tempo, monotone or overly soft speech

2

2

Slowed tempo with many pauses where he/she appears to drift. Hesitations include sighing. Voice qualities are distinctly monotonic and unanimated, and convey a sense of distress and psychic discomfort.

Slowed tempo with many pauses where he/she appears to drift. Hesitations include sighing.

3

3

 

 4

4

4

 

Extreme sense of psychic distress exhibited in voice or by a profound sense of hollowness or emptiness. Has difficulty conducting the interview.

5

5


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

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