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CDISC SDTM NPI Questionnaire Supplement (Version 1.0)

© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved

September 13, 2013

Neuropsychiatric Inventory (NPI)

Questionnaire Supplement to the Study Data

Tabulation Model Implementation Guide

for Human Clinical Trials

Prepared by

AD Standards Team and the CDISC Questionnaire Sub-team

notes to Readers

This 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

Date Version Summary of Changes

2013-07-10 1.0 Neuropsychiatric Inventory (NPI) Draft

2013-09-13 1.0 Neuropsychiatric Inventory (NPI)



September 13, 2013

1 Introduction This document describes the CDISC implementation of the Neuropsychiatric Inventory (NPI)

questionnaire, a standard questionnaire that is typically used in clinical trials to provide an assessment of psychopathology. It was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer’s disease and other

neurodegenerative disorders. The NPI has been used to characterize the neuropsychiatric symptom profiles in a variety of neurological diseases.

The NPI questionnaire preceded the CDISC CDASH CRF standards and based on its public domain status cannot be modified to CDASH standards.

The representation of data collected for this questionnaire is based on the Study Data Tabulation

Model Implementation Guide (SDTMIG) QS domain model, which can be found at the CDISC website at: (http://www.cdisc.org/sdtm).

These specific implementation details for this questionnaire are meant to be used in conjunction with the SDTMIG. All questionnaire documentation can be found on the CDISC web site at:

(http://www.cdisc.org/content2909). The CDISC Intellectual Property Policy can be found on the CDISC web site at:

(http://www.cdisc.org/bylaws-and-policies).

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the Study Data Tabulation Model Implementation Guide 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.

2 Copyright Status

This instrument is copyright approved. CDISC has included the Neuropsychiatric Inventory (NPI) as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and QSTEST for each

question based on the actual question text on the questionnaire. There may be many versions of this questionnaire in the public domain or copyright questionnaire. 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) case report forms annotated with the CDISC

SDTMIG submission values.

note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should be accessed through the CDISC website. (http://www.cdisc.org/terminology)

CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder.

http://www.cdisc.org/sdtm

http://www.cdisc.org/content2909

http://www.cdisc.org/bylaws-and-policies

http://www.cdisc.org/terminology



September 13, 2013

CDISC acknowledges Cummings, JL for the use of the Neuropsychiatric Inventory (NPI) (copyright JL Cummings, 1994, all rights reserved; permission for commercial use required; npitest.net) for the agreement to include the Neuropsychiatric Inventory in the CDISC data

standards.



September 13, 2013

3 The QS Domain Model

3.1 Assumptions for Questionnaire Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the Neuropsychiatric Inventory questionnaire are listed below.

Neuropsychiatric Inventory (NPI): NPI is a multiple choice questionnaire that clinicians use to provide an assessment of psychopathology. The NPI is based on responses from

an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient’s daytime and nighttime behaviors. If an

informed observer is not available, this instrument cannot be used or must be modified. The interview is best conducted with the caregiver in the absence of the patient to

facilitate an open discussion of behaviors that may be difficult to describe with the patient present.

The CRF consists of 12 question categories (i.e. Depression, Anxiety, Delusions) where

the observer is asked if the subject is experiencing these conditions. Some clinicians choose to use only the first ten categories. Each categorical question has a series of

“YES/NO” sub-questions if the respondent answers “YES” to the categorical question. These provide more detail on the nature of the subject’s condition. Additionally, if the subject answers “YES” to the categorical question, there are questions about frequency,

severity and distress caused by the condition.

1. The frequency and severity include a rating (e.g. “Mild”) and a definition of what is

represented by the rating (e.g. “occasionally- less than once a week; Moderate—delusions are distressing and disruptive). For NPI, QSORRES is populated with the rating only. The rating definition is considered a reference for the evaluator to use in

assigning a rating and is not submitted in SDTM.

2. If a categorical question is answered “NO” or “NA”, the sub-questions are not entered into SDTM, since they are not asked. Please refer to the annotated CRF and rows 14 and

50 of the example data below to determine how to correctly record these questions. “NO”

and “NA” do have a numeric code assigned to them. This is entered in QSSTRESC and QSSTRESN.

3. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled

terminology. b. A full list of value sets for qualifier, timing, result and unit fields is provided

in Section 4: SDTM Mapping Strategy.

4. (QSSCAT= SLEEP AND NIGHTTIME BEHAVIOR DISORDERS) and

(QSSCAT=APPETITE AND EATING DISORDERS) were added after the original publication of the NPI (Cummings et al,1994). They were included because they are common problem areas in Alzheimer’s disease and other dementias. They form part

of the depression syndrome in some patients and were specifically excluded from the dysphoria subscale of the NPI in order to allow that subscale to focus on mood



September 13, 2013

symptoms. These two symptoms are usually not included in the total NPI score and may not be included in all protocols



September 13, 2013

3.2 Example for Neuropsychiatric Inventory (NPI) QS Domain Model

The NPI example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for one subject collected

at visit=2 for a NPI questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. The QSBLFL variable is not shown, since the data is recorded at visitnum=2. All original results are represented with the terminology on the CRF in QSORRES. This result is then

transformed into a standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC. Each page of the CRF is a separate sub-category (QSSCAT) with sub-questions to be answered if the categorical question is answered “YES”. As stated in

assumption 4, QSSCAT= SLEEP AND NIGHTTIME BEHAVIOR DISORDERS) and (QSSCAT=APPETITE AND EATING DISORDERS) are not included in this example’s total score.

Rows 1-13: Show categorical question and sub-questions for QSSCAT=DELUSIONS. Row 14: Shows a case where the categorical question (QSSCAT= HALLUCINATIONS) was answered “NO”. The sub- questions are not included in

the data, as per assumption number 5.

Rows 15-26: Show categorical question and the sub-questions for QSSCAT=AGITATION\AGGRESSION. Rows 27-38: Show categorical question and the sub-questions for QSSCAT= DEPRESSION/DYSPHORIA.

Rows 39-49: Show categorical question and the sub-questions for QSSCAT= ANXIETY. Row 50: Shows a case where the categorical question (QSSCAT=ELATION/EUPHORIA) was answered “NA”. The sub-questions are not included in

the data, as per assumption number 5.

Rows 51-62: Show categorical question and the sub-questions for QSSCAT= APATHY/INDIFFERENCE. Rows 63-73: Show categorical question and the sub-questions for QSSCAT= DISINHIBITION. Rows 74-84: Represent categorical question and the questions related to the QSSCAT= IRRATIBILITY/LABILITY.

Rows 85-95: Show categorical question and the sub-questions for QSSCAT= ABERRANT MOTOR BEHAVIOR. Rows 96-107: Show categorical question and the sub-questions for QSSCAT= SLEEP AND NIGHTTIME BEHAVIOR DISORDERS.

Rows 108-119: Show categorical question and the sub-questions for QSSCAT= APPETITE AND EATING DISORDERS. Rows 120-131: Show the (Frequency) times (Severity) scores for each category of questions. See the scoring instructions in the CRF for an explanation of

how to score these fields. Rows 121 and 125 are scored “0” since the sub-questions were not answered. See the explanations above for rows

14 and 50. Row 132: Shows the sum of all scores obtained in rows 120-130. Rows 130 and 131 are not included in the total score, per assumption 4.

Row 133: Shows the sum of all “Distress” scores for each category of questions. See the scoring instructions in the CRF for an explanation of how to score these fields.



September 13, 2013

qs.xpt

Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SSCAT Q SO RRES Q SSTRESC Q SSTRESN VISITNUM Q SDTC

1 STUDYX QS P0001 1 NPI1A NPI1-Beliefs Untrue NPI DELUSIONS YES Y 2

2012-11-

16

2 STUDYX QS P0001 2 NPI1A01 NPI1-In Danger NPI DELUSIONS YES Y 2 2012-11-

16

3 STUDYX QS P0001 3 NPI1A02 NPI1-Others Are

Stealing NPI DELUSIONS YES Y 2

2012-11-

16

4 STUDYX QS P0001 4 NPI1A03 NPI1-Spouse Having

Affair NPI DELUSIONS NO N 2

2012-11-

16

5 STUDYX QS P0001 5 NPI1A04 NPI1-Unwelcome

Guests in House NPI DELUSIONS NO N 2

2012-11-

16

6 STUDYX QS P0001 6 NPI1A05 NPI1-People Nt Who

They Claim NPI DELUSIONS YES Y 2

2012-11-

16

7 STUDYX QS P0001 7 NPI1A06 NPI1-House Nt Their

Home NPI DELUSIONS YES Y 2

2012-11-

16

8 STUDYX QS P0001 8 NPI1A07 NPI1-Family Plans to

Abandon NPI DELUSIONS NO N 2

2012-11-

16

9 STUDYX QS P0001 9 NPI1A08 NPI1-TV/Magazine

Figures Present NPI DELUSIONS NO N 2

2012-11-

16

10 STUDYX QS P0001 10 NPI1A09

NPI1-Other Unusual

Beliefs NPI DELUSIONS YES Y 2

2012-11-

16

11 STUDYX QS P0001 11 NPI1A10 NPI1-Delusions

Frequency NPI DELUSIONS Often 2 2 2

2012-11-

16

12 STUDYX QS P0001 12 NPI1A11 NPI1-Delusions Severity NPI DELUSIONS Moderate 2 2 2 2012-11-

16

13 STUDYX QS P0001 13 NPI1A12 NPI1-Delusions Distress NPI DELUSIONS Mildly 2 2 2 2012-11-

16

14 STUDYX QS P0001 14 NPI1B

NPI1-False Visions or

Voices NPI HALLUCINATIONS NO N 2

2012-11-

16



September 13, 2013


15 STUDYX QS P0001 15 NPI1C NPI1-Refuse to

Cooperate NPI

AGITATION/

AGGRESSION YES Y 2

2012-11-

16

16 STUDYX QS P0001 16 NPI1C01 NPI1-Get Upset with

Caregiver NPI

AGITATION/

AGGRESSION YES Y 2

2012-11-

16

17 STUDYX QS P0001 17 NPI1C02 NPI1-Stubborn NPI AGITATION/

AGGRESSION YES Y 2

2012-11-

16

18 STUDYX QS P0001 18 NPI1C03 NPI1-Uncooperative NPI AGITATION/

AGGRESSION NO N 2

2012-11-

16

19 STUDYX QS P0001 19 NPI1C04 NPI1-Other Behaviors

Hard to Handle NPI

AGITATION/

AGGRESSION NO N 2

2012-11-

16

20 STUDYX QS P0001 20 NPI1C05 NPI1-Shout or Curse

Angrily NPI

AGITATION/

AGGRESSION YES Y 2

2012-11-

16

21 STUDYX QS P0001 21 NPI1C06 NPI1-Slam, Kick or

Throw Things NPI

AGITATION/

AGGRESSION YES Y 2

2012-11-

16

22 STUDYX QS P0001 22 NPI1C07 NPI1-Hurt or Hit Others NPI AGITATION/

AGGRESSION YES Y 2

2012-11-

16

23 STUDYX QS P0001 23 NPI1C08

NPI1-Other Aggressive

Behavior NPI

AGITATION/

AGGRESSION NO N 2

2012-11-

16

24 STUDYX QS P0001 24 NPI1C09 NPI1-Agitation/

Aggression Frequency NPI

AGITATION/

AGGRESSION Very frequently 4 4 2

2012-11-

16

25 STUDYX QS P0001 25 NPI1C10

NPI1-Agitation/

Aggression Severity NPI

AGITATION/

AGGRESSION Moderate 2 2 2

2012-11-

16

26 STUDYX QS P0001 26 NPI1C11 NPI1-Agitation/

Aggression Distress NPI

AGITATION/

AGGRESSION Severely 4 4 2

2012-11-

16

27 STUDYX QS P0001 27 NPI1D NPI1-Sad or Depressed NPI

DEPRESSION/

DYSPHORIA YES Y 2

2012-11-

16

28 STUDYX QS P0001 28 NPI1D01 NPI1-Tearfulness or

Sobbing NPI

DEPRESSION/

DYSPHORIA NO N 2

2012-11-

16

29 STUDYX QS P0001 29 NPI1D02 NPI1-Say or Act in Low

Spirits NPI

DEPRESSION/

DYSPHORIA YES Y 2

2012-11-

16

30 STUDYX QS P0001 30 NPI1D03 NPI1-Feel Like a Failure NPI DEPRESSION/

DYSPHORIA YES Y 2

2012-11-

16



September 13, 2013


31 STUDYX QS P0001 31 NPI1D04 NPI1-Bad Person NPI DEPRESSION/ DYSPHORIA NO N 2 2012-11-

16

32 STUDYX QS P0001 32 NPI1D05 NPI1-Discouraged NPI DEPRESSION/

DYSPHORIA YES Y 2

2012-11-

16

33 STUDYX QS P0001 33 NPI1D06 NPI1-Burden to Family NPI DEPRESSION/

DYSPHORIA YES Y 2

2012-11-

16

34 STUDYX QS P0001 34 NPI1D07 NPI1-Wish for Death NPI DEPRESSION/

DYSPHORIA NO N 2

2012-11-

16

35 STUDYX QS P0001 35 NPI1D08 NPI1-Other Signs of

Depression NPI DEPRESSION/ DYSPHORIA NO N 2

2012-11-

16

36 STUDYX QS P0001 36 NPI1D09 NPI1-Depression/

Dysphoria Frequency NPI DEPRESSION/ DYSPHORIA Very frequently 4 4 2

2012-11-

16


Dysphoria Severity NPI DEPRESSION/ DYSPHORIA Marked 3 3 2

2012-11-

16


Dysphoria Distress NPI DEPRESSION/ DYSPHORIA Severely 4 4 2

2012-11-

16

39 STUDYX QS P0001 39 NPI1E

NPI1-Nervous or

Worried NPI ANXIETY YES Y 2

2012-11-

16

40 STUDYX QS P0001 40 NPI1E01 NPI1-Worried about

Planned Event NPI ANXIETY YES Y 2

2012-11-

16

41 STUDYX QS P0001 41 NPI1E02

NPI1-Shaky or Unable

to Relax NPI ANXIETY YES Y 2

2012-11-

16

42 STUDYX QS P0001 42 NPI1E03 NPI1-Short of Breath,

Gasp, Sigh NPI ANXIETY YES Y 2

2012-11-

16

43 STUDYX QS P0001 43 NPI1E04

NPI1-Butterfies or

Racing Heart NPI ANXIETY NO N 2

2012-11-

16

44 STUDYX QS P0001 44 NPI1E05 NPI1-Avoid Places or

Situations NPI ANXIETY YES Y 2

2012-11-

16

45 STUDYX QS P0001 45 NPI1E06 NPI1-Nervous when

Separated NPI ANXIETY YES Y 2

2012-11-

16

46 STUDYX QS P0001 46 NPI1E07 NPI1-Other Signs of

Anxiety NPI ANXIETY YES Y 2

2012-11-

16



September 13, 2013


47 STUDYX QS P0001 47 NPI1E08 NPI1-Anxiety

Frequency NPI ANXIETY Very frequently 4 4 2

2012-11-

16

48 STUDYX QS P0001 48 NPI1E09 NPI1-Anxiety Severity NPI ANXIETY Often 2 2 2 2012-11-

16

49 STUDYX QS P0001 49 NPI1E10 NPI1-Anxiety Distress NPI ANXIETY Moderately 3 3 2 2012-11-

16

50 STUDYX QS P0001 50 NPI1F NPI1-Too Cheerful or

Happy NPI ELATION/ EUPHORIA NA NA 2

2012-11-

16

51 STUDYX QS P0001 51 NPI1G NPI1-Lost Interest in

World NPI APATHY/ INDIFFERENCE YES Y 2

2012-11-

16

52 STUDYX QS P0001 52 NPI1G01 NPI1-Less Spontaneous

or Active NPI APATHY/ INDIFFERENCE YES Y 2

2012-11-

16

53 STUDYX QS P0001 53 NPI1G02 NPI1-Less Likely

Initiate Conversation NPI APATHY/ INDIFFERENCE YES Y 2

2012-11-

16

54 STUDYX QS P0001 54 NPI1G03 NPI1-Less Affectionate NPI APATHY/ INDIFFERENCE YES Y 2 2012-11-

16

55 STUDYX QS P0001 55 NPI1G04

NPI1-Contribute Less to

Chores NPI APATHY/INDIFFERENCE YES Y 2

2012-11-

16

56 STUDYX QS P0001 56 NPI1G05 NPI1-Less Interest in

Activities NPI APATHY/ INDIFFERENCE YES Y 2

2012-11-

16


NPI1-Lost Interest in

Friends NPI APATHY/ INDIFFERENCE YES Y 2

2012-11-

16

58 STUDYX QS P0001 58 NPI1G07 NPI1-Less Enthusiastic NPI APATHY/ INDIFFERENCE YES Y 2 2012-11-

16


NPI1-Other Signs of Nt

Caring NPI

APATHY/

INDIFFERENCE YES Y 2

2012-11-

16

60 STUDYX QS P0001 60 NPI1G09 NPI1-Apathy/

Indifference Frequency NPI

APATHY/

INDIFFERENCE Very frequently 4 4 2

2012-11-

16


Indifference Severity NPI APATHY/

INDIFFERENCE Marked 3 3 2

2012-11-

16


Indifference Distress NPI

APATHY/

INDIFFERENCE

Very severely or

extremely 5 5 2

2012-11-

16



September 13, 2013


63 STUDYX QS P0001 63 NPI1H NPI1-Act Impulsively NPI DISINHIBITION YES Y 2 2012-11-

16

64 STUDYX QS P0001 64 NPI1H01 NPI1-Act Impulsively

without Care NPI DISINHIBITION YES Y 2

2012-11-

16

65 STUDYX QS P0001 65 NPI1H02 NPI1-Talk to Strangers NPI DISINHIBITION NO N 2 2012-11-

16

66 STUDYX QS P0001 66 NPI1H03 NPI1-Say Insensitive

Things NPI DISINHIBITION NO N 2

2012-11-

16

67 STUDYX QS P0001 67 NPI1H04 NPI1-Make Crude

Remarks NPI DISINHIBITION NO N 2

2012-11-

16

68 STUDYX QS P0001 68 NPI1H05 NPI1-Talk Openly about

Private Matters NPI DISINHIBITION NO N 2

2012-11-

16

69 STUDYX QS P0001 69 NPI1H06 NPI1-Take Liberties or

Touch Others NPI DISINHIBITION NO N 2

2012-11-

16

70 STUDYX QS P0001 70 NPI1H07 NPI1-Other Signs of

Impulses NPI DISINHIBITION YES Y 2

2012-11-

16

71 STUDYX QS P0001 71 NPI1H08

NPI1-Disinhibition

Frequency NPI DISINHIBITION Occasionally 1 1 2

2012-11-

16

72 STUDYX QS P0001 72 NPI1H09 NPI1-Disinhibition

Severity NPI DISINHIBITION Mild 1 1 2

2012-11-

16

73 STUDYX QS P0001 73 NPI1H10

NPI1-Disinhibition

Distress NPI DISINHIBITION Minimally 1 1 2

2012-11-

16

74 STUDYX QS P0001 74 NPI1I NPI1-Irritated and Easily

Disturbed NPI

IRRATIBILITY/

LABILITY YES Y 2

2012-11-

16

75 STUDYX QS P0001 75 NPI1I01 NPI1-Bad Temper NPI

IRRATIBILITY/

LABILITY YES Y 2

2012-11-

16

76 STUDYX QS P0001 76 NPI1I02 NPI1-Rapidly Change

Moods NPI

IRRATIBILITY/

LABILITY YES Y 2

2012-11-

16

77 STUDYX QS P0001 77 NPI1I03 NPI1-Sudden Anger NPI IRRATIBILITY/

LABILITY NO N 2

2012-11-

16

78 STUDYX QS P0001 78 NPI1I04 NPI1-Impatient NPI IRRATIBILITY/

LABILITY YES Y 2

2012-11-

16



September 13, 2013


79 STUDYX QS P0001 79 NPI1I05 NPI1-Cranky and

Irritable NPI

IRRATIBILITY/

LABILITY YES Y 2

2012-11-

16

80 STUDYX QS P0001 80 NPI1I06 NPI1-Argumentative NPI IRRATIBILITY/

LABILITY YES Y 2

2012-11-

16

81 STUDYX QS P0001 81 NPI1I07 NPI1-Other Signs of

Irritability NPI

IRRATIBILITY/

LABILITY YES Y 2

2012-11-

16

82 STUDYX QS P0001 82 NPI1I08 NPI1-Irritability/

Lability Frequency NPI

IRRATIBILITY/

LABILITY Very frequently 4 4 2

2012-11-

16


Lability Severity NPI IRRATIBILITY/

LABILITY Moderate 2 2 2

2012-11-

16


Lability Distress NPI

IRRATIBILITY/

LABILITY Moderately 3 3 2

2012-11-

16

85 STUDYX QS P0001 85 NPI1J NPI1-Do Things

Repeatedly NPI

ABERRANT MOTOR

BEHAVIOR YES Y 2

2012-11-

16

86 STUDYX QS P0001 86 NPI1J01 NPI1-Pace NPI ABERRANT MOTOR

BEHAVIOR YES Y 2

2012-11-

16

87 STUDYX QS P0001 87 NPI1J02

NPI1-Rummage Around

and Unpack NPI

ABERRANT MOTOR

BEHAVIOR YES Y 2

2012-11-

16

88 STUDYX QS P0001 88 NPI1J03 NPI1-Repeatedly

Change Clothing NPI

ABERRANT MOTOR

BEHAVIOR NO N 2

2012-11-

16

89 STUDYX QS P0001 89 NPI1J04

NPI1-Repetitive

Activities or Habits NPI

ABERRANT MOTOR

BEHAVIOR YES Y 2

2012-11-

16

90 STUDYX QS P0001 90 NPI1J05 NPI1-Repetitive

Activities NPI

ABERRANT MOTOR

BEHAVIOR YES Y 2

2012-11-

16

91 STUDYX QS P0001 91 NPI1J06 NPI1-Fidget Excessively NPI

ABERRANT MOTOR

BEHAVIOR YES Y 2

2012-11-

16

92 STUDYX QS P0001 92 NPI1J07 NPI1-Other Repetitive

Activities NPI

ABERRANT MOTOR

BEHAVIOR YES Y 2

2012-11-

16

93 STUDYX QS P0001 93 NPI1J08 NPI1-Aberrant Motor

Behavior Frequency NPI

ABERRANT MOTOR

BEHAVIOR Very frequently 4 4 2

2012-11-

16


Behavior Severity NPI

ABERRANT MOTOR

BEHAVIOR Moderate 2 2 2

2012-11-

16



September 13, 2013



Behavior Distress NPI

ABERRANT MOTOR

BEHAVIOR Severely 4 4 2

2012-11-

16

96 STUDYX QS P0001 96 NPI1K NPI1-Difficulty

Sleeping NPI

SLEEP AND NIGHTTIME

BEHAVIOR DISORDERS YES Y 2

2012-11-

16

97 STUDYX QS P0001 97 NPI1K01 NPI1-Difficulty Falling

Asleep NPI

SLEEP AND NIGHTTIME


2012-11-

16

98 STUDYX QS P0001 98 NPI1K02 NPI1-Get Up during

Night NPI

SLEEP AND NIGHTTIME


2012-11-

16

99 STUDYX QS P0001 99 NPI1K03 NPI1-Wander or Pace at

Night NPI

SLEEP AND NIGHTTIME


2012-11-

16

100 STUDYX QS P0001 100 NPI1K04 NPI1-Awaken Caregiver

during Night NPI

SLEEP AND NIGHTTIME


2012-11-

16

101 STUDYX QS P0001 101 NPI1K05 NPI1-Wake at Night and

Think Morning NPI

SLEEP AND NIGHTTIME


2012-11-

16

102 STUDYX QS P0001 102 NPI1K06 NPI1-Awaken Too Early

in Morning NPI

SLEEP AND NIGHTTIME


2012-11-

16

103 STUDYX QS P0001 103 NPI1K07

NPI1-Excessive Sleep

during Day NPI

SLEEP AND NIGHTTIME


2012-11-

16

104 STUDYX QS P0001 104 NPI1K08 NPI1-Other Nighttime

Behaviors NPI

SLEEP AND NIGHTTIME

BEHAVIOR DISORDERS NO N 2

2012-11-

16


NPI1-Sleep/

Nighttime Behavior

Frequency

NPI SLEEP AND NIGHTTIME

BEHAVIOR DISORDERS Very frequently 4 4 2

2012-11-

16


NPI1-Sleep/

Nighttime Behavior

Severity

NPI SLEEP AND NIGHTTIME BEHAVIOR DISORDERS

Marked 3 3 2 2012-11-

16


NPI1-Sleep/

Nighttime Behavior

Distress

NPI SLEEP AND NIGHTTIME

BEHAVIOR DISORDERS

Very severely or

extremely 5 5 2

2012-11-

16

108 STUDYX QS P0001 108 NPI1L NPI1-Change in

Appetite or Weight NPI

APPETITE AND EATING

DISORDERS YES Y 2

2012-11-

16

109 STUDYX QS P0001 109 NPI1L01 NPI1-Loss of Appetite NPI APPETITE AND EATING

DISORDERS NO N 2

2012-11-

16



September 13, 2013


110 STUDYX QS P0001 110 NPI1L02 NPI1-Increase in

Appetite NPI

APPETITE AND EATING

DISORDERS YES Y 2

2012-11-

16

111 STUDYX QS P0001 111 NPI1L03 NPI1-Weight Loss NPI APPETITE AND EATING

DISORDERS NO N 2

2012-11-

16

112 STUDYX QS P0001 112 NPI1L04 NPI1-Weight Gain NPI APPETITE AND EATING

DISORDERS NO N 2

2012-11-

16

113 STUDYX QS P0001 113 NPI1L05 NPI1-Change in Eating

Behavior NPI

APPETITE AND EATING

DISORDERS NO N 2

2012-11-

16

114 STUDYX QS P0001 114 NPI1L06 NPI1-Change in Kind of

Food NPI

APPETITE AND EATING

DISORDERS NO N 2

2012-11-

16

115 STUDYX QS P0001 115 NPI1L07 NPI1-Develop Eating

Behaviors NPI

APPETITE AND EATING

DISORDERS NO N 2

2012-11-

16

116 STUDYX QS P0001 116 NPI1L08 NPI1-Other Changes in

Eating NPI

APPETITE AND EATING

DISORDERS NO N 2

2012-11-

16

117 STUDYX QS P0001 117 NPI1L09 NPI1-Appetite/Eating

Disorder Frequency NPI

APPETITE AND EATING

DISORDERS Frequently 3 3 2

2012-11-

16

118 STUDYX QS P0001 118 NPI1L10

NPI1-Appetite/Eating

Disorder Severity NPI APPETITE AND EATING

DISORDERS Mild. 1 1 2

2012-11-

16

119 STUDYX QS P0001 119 NPI1L11 NPI1-Appetite/Eating

Disorder Distress NPI

APPETITE AND EATING

DISORDERS Not at all 0 0 2

2012-11-

16

120 STUDYX QS P0001 120 NPI1AFS

NPI1-Delusions FxS

Score NPI DELUSIONS 4 4 4 2

2012-11-

16

121 STUDYX QS P0001 121 NPI1BFS NPI1-Hallucinations

FxS Score NPI HALLUCINATIONS 0 0 0 2

2012-11-

16

122 STUDYX QS P0001 122 NPI1CFS

NPI1-Agitation/

Aggression FxS Score NPI

AGITATION/

AGGRESSION 8 8 8 2

2012-11-

16

123 STUDYX QS P0001 123 NPI1DFS NPI1-Depression/

Dysphoria FxS Score NPI

DEPRESSION/

DYSPHORIA 12 12 12 2

2012-11-

16

124 STUDYX QS P0001 124 NPI1EFS NPI1-Anxiety FxS Score NPI ANXIETY 8 8 8 2 2012-11-

16

125 STUDYX QS P0001 125 NPI1FFS NPI1-Elation/Euphoria

FxS Score NPI ELATION/ EUPHORIA 0 0 0 2

2012-11-

16



September 13, 2013


126 STUDYX QS P0001 126 NPI1GFS NPI1-Apathy/

Indifference FxS Score NPI

APATHY/ INDIFFERENCE

12 12 12 2 2012-11-

16

127 STUDYX QS P0001 127 NPI1HFS NPI1-Disinhibition FxS

Score NPI DISINHIBITION 1 1 1 2

2012-11-

16

128 STUDYX QS P0001 128 NPI1IFS NPI1-Irritability/Lability

FxS Score NPI

IRRATIBILITY/

LABILITY 8 8 8 2

2012-11-

16

129 STUDYX QS P0001 129 NPI1JFS NPI1-Aberrant Motor

Behavior FxS Score NPI

ABERRANT MOTOR

BEHAVIOR 8 8 8 2

2012-11-

16

130 STUDYX QS P0001 130 NPI1KFS NPI1-Sleep/Night Behav

Disord FxS Score NPI

SLEEP AND NIGHTTIME

BEHAVIOR DISORDERS 12 12 12 2

2012-11-

16

131 STUDYX QS P0001 131 NPI1LFS NPI1-Appetite/Eating

Disorders FxS Score NPI

APPETITE AND EATING

DISORDERS 3 3 3 2

2012-11-

16

132 STUDYX QS P0001 132 NPI1TOT NPI1-NPI Total Score NPI 61 61 61 2 2012-11-

16

133 STUDYX QS P0001 133 NPI1DIST NPI1-NPI Total Distress

Score NPI 31 31 31 2

2012-11-

16



September 13, 2013

4 SDTM Mapping Strategy

NPI specific mapping strategy: This section is used for reference with the annotated CRF for further details on the CRF data capture and to understand the alignment of the questionnaire to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated for the questionnaire.

QSSCAT VALUES

Following is a list of QSSCAT values and the range of QSTESCDs they include: QSSCAT=DELUSIONS QSTESTCD=NPI1A01-NPI1A12

QSSCAT=HALLUCINATIONS QSTESTCD=NPI1B01-NPI1B10

QSSCAT=AGITATION/AGGRESSION QSTESTCD=NPI1C01-NPI1C11

QSSCAT=DEPRESSION/DYSPHORIA QSTESTCD=NPI1D01-NPI1D11

QSSCAT=ANXIETY QSTESTCD=NPI1E01-NPI1E10

QSSCAT=ELATION/EUPHORIA QSTESTCD=NPI1F01-NPI1F10

QSSCAT=APATHY/INDIFFERENCE QSTESTCD=NPI1G01-NPI1G11 QSSCAT=DISINHIBITION QSTESTCD=NPI1H01-NPI1H10

QSSCAT=IRRITABILITY/LABILITY QSTESTCD=NPI1I01-NPI1I11

QSSCAT=ABERRANT MOTOR BEHAVIOR QSTESTCD=NPI1J01-NPI1J10

QSSCAT=SLEEP AND NIGHTTIME BEHAVIOR DISORDERS QSTESTCD=NPI1K01-NPI1K11

QSSCAT=APPETITE AND EATING DISORDERS QSTESTCD=NPI1L01-NPI1L11

YES/NO answers

QSSCAT=DELUSIONS QSTESTCD=NPI1A01-NPI1A09 QSSCAT=HALLUCINATIONS QSTESTCD=NPI1B01-NPI1B07

QSSCAT=AGITATION/AGGRESSION QSTESTCD=NPI1C01-NPI1C08

QSSCAT=DEPRESSION/DYSPHORIA QSTESTCD=NPI1D01-NPI1D08

QSSCAT=ANXIETY QSTESTCD=NPI1E01-NPI1E07

QSSCAT=ELATION/EUPHORIA QSTESTCD=NPI1F01-NPI1F07

QSSCAT=APATHY/INDIFFERENCE QSTESTCD=NPI1G01-NPI1G08

QSSCAT=DISINHIBITION QSTESTCD=NPI1H01-NPI1H07 QSSCAT=IRRITABILITY/LABILITY QSTESTCD=NPI1I01-NPI1I07

QSSCAT=ABERRANT MOTOR BEHAVIOR QSTESTCD=NPI1J01-NPI1J07

QSSCAT=SLEEP AND NIGHTTIME BEHAVIOR DISORDERS QSTESTCD=NPI1K01-NPI1K08

QSSCAT=APPETITE AND EATING DISORDERS QSTESTCD=NPI1L01-NPI1L08



September 13, 2013

QSORRES QSSTRESC QSSTRESN

YES Y NO N

QSSCAT=DELUSIONS QSTESTCD=NPI1A QSTEST=NPI1-Beliefs Untrue

QSSCAT=HALLUCINATIONS QSTESTCD=NPI1B QSTEST=NPI1-False Visions or Voices QSSCAT=AGITATION/AGGRESSION QSTESTCD=NPI1C QSTEST=NPI1-Refuse to Cooperate

QSSCAT=DEPRESSION/DYSPHORIA QSTESTCD=NPI1D QSTEST=NPI1-Sad or Depressed

QSSCAT=ANXIETY QSTESTCD=NPI1E QSTEST=NPI1-Nervous or Worried

QSSCAT=ELATION/EUPHORIA QSTESTCD=NPI1F QSTEST=NPI1-Too Cheerful or Happy

QSSCAT=APATHY/INDIFFERENCE QSTESTCD=NPI1G QSTEST=NPI1-Lost Interest in World

QSSCAT=DISINHIBITION QSTESTCD=NPI1H QSTEST=NPI1-Act Impulsively

QSSCAT=IRRITABILITY/LABILITY QSTESTCD=NPI1I QSTEST=NPI1-Irritated and Easily Disturbed

QSSCAT=ABERRANT MOTOR BEHAVIOR QSTESTCD=NPI1J QSTEST=NPI1-Do Things Repeatedly QSSCAT=SLEEP AND NIGHTTIME BEHAVIOR DISORDERS QSTESTCD=NPI1K QSTEST=NPI1-Difficulty Sleeping

QSSCAT=APPETITE AND EATING DISORDERS QSTESTCD=NPI1L QSTEST=NPI1-Change in Appetite or Weight

QSORRES QSSTRESC QSSTRESN YES Y

NO N NA NA

QSSCAT=DELUSIONS QSTESTCD=NPI1A10 QSTEST=NPI1-Delusions Frequency QSSCAT=HALLUCINATIONS QSTESTCD=NPI1B08 QSTEST=NPI1-Hallucinations Frequency

QSSCAT=AGITATION/AGGRESSION QSTESTCD=NPI1C09 QSTEST=NPI1-Agitation/Aggression Frequency

QSSCAT=DEPRESSION/DYSPHORIA QSTESTCD=NPI1D09 QSTEST=NPI1-Depression/Dysphoria Frequency

QSSCAT=ANXIETY QSTESTCD=NPI1E08 QSTEST=NPI1-Anxiety Frequency

QSSCAT=ELATION/EUPHORIA QSTESTCD=NPI1F08 QSTEST=NPI1-Elation/Euphoria Frequency

QSSCAT=APATHY/INDIFFERENCE QSTESTCD=NPI1G09 QSTEST=NPI1-Apathy/Indifference Frequency

QSSCAT=DISINHIBITION QSTESTCD=NPI1H08 QSTEST=NPI1-Disinhibition

QSSCAT=IRRITABILITY/LABILITY QSTESTCD=NPI1I08 QSTEST=NPI1-Irritability/Lability Frequency QSSCAT=ABERRANT MOTOR BEHAVIOR QSTESTCD=NPI1J08 QSTEST=NPI1-Aberrant Motor Behavior Frequency

QSSCAT=SLEEP AND NIGHTTIME BEHAVIOR QSTESTCD=NPI1K09 QSTEST=Sleep/Nighttime Behavior Frequency

DISORDERS

QSSCAT=APPETITE AND EATING DISORDERS QSTESTCD=NPI1L09 QSTEST=NPI1-Irritability/Lability Frequency



September 13, 2013


Occasionally 1 1 Often 2 2

Frequently 3 3 Very frequently 4 4

QSSCAT=DELUSIONS QSTESTCD=NPI1A11 QSTEST=NPI1-Delusions Distress

QSSCAT=HALLUCINATIONS QSTESTCD=NPI1B09 QSTEST=NPI1-Hallucinations Distress QSSCAT=AGITATION/AGGRESSION QSTESTCD=NPI1C10 QSTEST=NPI1-Agitation/Aggression Distress

QSSCAT=DEPRESSION/DYSPHORIA QSTESTCD=NPI1D10 QSTEST=NPI1-Depression/Dysphoria Distress QSSCAT=ANXIETY QSTESTCD=NPI1E09 QSTEST=NPI1-Anxiety Distress

QSSCAT=ELATION/EUPHORIA QSTESTCD=NPI1F09 QSTEST=NPI1-Elation/Euphoria Distress

QSSCAT=APATHY/INDIFFERENCE QSTESTCD=NPI1G10 QSTEST=NPI1-Apathy/Indifference Distress

QSSCAT=DISINHIBITION QSTESTCD=NPI1H09 QSTEST=NPI1-Disinhibition Distress

QSSCAT=IRRITABILITY/LABILITY QSTESTCD=NPI1I09 QSTEST=NPI1-Irritability/Lability Distress

QSSCAT=ABERRANT MOTOR BEHAVIOR QSTESTCD=NPI1J09 QSTEST=NPI1-Aberrant Motor Behavior Distress QSSCAT=SLEEP AND NIGHTTIME BEHAVIOR QSTESTCD=NPI1K10 QSTEST=NPI1-Sleep/Nighttime Behavior Distress

DISORDERS

QSSCAT=APPETITE AND EATING DISORDERS QSTESTCD=NPI1L10 QSTEST=NPI1-Appetite/Eating Disorder Distress


Mild 1 1 Moderate 2 2

Marked 3 3

QSSCAT=DELUSIONS QSTESTCD=NPI1A12 QSTEST=NPI1-Delusions Distress

QSSCAT=HALLUCINATIONS QSTESTCD=NPI1B10 QSTEST=NPI1-Hallucinations Distress

QSSCAT=AGITATION/AGGRESSION QSTESTCD=NPI1C11 QSTEST=NPI1-Agitation/Aggression Distress

QSSCAT=DEPRESSION/DYSPHORIA QSTESTCD=NPI1D11 QSTEST=NPI1-Depression/Dysphoria Distress QSSCAT=ANXIETY QSTESTCD=NPI1E10 QSTEST=NPI1-Anxiety Distress

QSSCAT=ELATION/EUPHORIA QSTESTCD=NPI1F10 QSTEST=NPI1-Elation/Euphoria Distress QSSCAT=APATHY/INDIFFERENCE QSTESTCD=NPI1G11 QSTEST=NPI1-Apathy/Indifference Distress

QSSCAT=DISINHIBITION QSTESTCD=NPI1H10 QSTEST=NPI1-Disinhibition Distress

QSSCAT=IRRITABILITY/LABILITY QSTESTCD=NPI1I10 QSTEST=NPI1-Irritability/Lability Distress



September 13, 2013

QSSCAT=ABERRANT MOTOR BEHAVIOR QSTESTCD=NPI1J10 QSTEST=NPI1-Aberrant Motor Behavior Distress

QSSCAT=SLEEP AND NIGHTTIME BEHAVIOR QSTESTCD=NPI1K11 QSTEST=NPI1-Sleep/Nighttime Behavior Distress DISORDERS

QSSCAT=APPETITE AND EATING DISORDERS QSTESTCD=NPI1L11 QSTEST=NPI1-Appetite/Eating Disorder Distress

QSORRES QSSTRESC QSSTRESN Not at all 0 0

Minimally 1 1 Mildly 2 2

Moderately 3 3 Severely 4 4

Very severely or extremely 5 5

End of Document

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