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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.
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
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
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.
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=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=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