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© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1 June 30, 2014 Mayo-Portland Adaptability Inventory (MPAI-4) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by TBI 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 2014-05-28 1.0 Mayo-Portland Adaptability Inventory (MPAI-4) Draft 2014-06-30 1.0 Mayo-Portland Adaptability Inventory (MPAI-4)

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Page 1: Mayo-Portland Adaptability Inventory (MPAI-4) - CDISCportal.cdisc.org/Questionnaire Documentation/Mayo-Portland... · © 2014 Page Clinical Data Interchange Standards Consortium,

© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1 June 30, 2014

Mayo-Portland Adaptability Inventory

(MPAI-4)

Questionnaire Supplement to the Study Data

Tabulation Model Implementation Guide

for Human Clinical Trials

Prepared by

TBI 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

2014-05-28 1.0 Mayo-Portland Adaptability Inventory (MPAI-4) Draft

2014-06-30 1.0 Mayo-Portland Adaptability Inventory (MPAI-4)

Page 2: Mayo-Portland Adaptability Inventory (MPAI-4) - CDISCportal.cdisc.org/Questionnaire Documentation/Mayo-Portland... · © 2014 Page Clinical Data Interchange Standards Consortium,

CDISC SDTM MPAI-4 Questionnaire Supplement (Version 1.0)

© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2 June 30, 2014

1 Introduction This document describes the CDISC implementation of the Mayo-Portland Adaptability

Inventory (MPAI-4) questionnaire, an ordinal clinical rating scale developed to measure

accurately general functional changes over the course of recovery from a traumatic brain injury.

The Mayo-Portland Adaptability Inventory (MPAI-4) 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 in the public domain. CDISC has included the Mayo-Portland Adaptability

Inventory (MPAI-4) 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. 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)

The reference for this questionnaire is:

Malec, J. (2005). The Mayo-Portland Adaptability Inventory. The Center for Outcome

Measurement in Brain Injury. http://www.tbims.org/combi/mpai (accessed March 22,

2014 ).

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CDISC SDTM MPAI-4 Questionnaire Supplement (Version 1.0)

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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 Mayo-Portland Adaptability Inventory

(MPAI-4) questionnaire are listed below.

Mayo-Portland Adaptability Inventory (MPAI-4) is an ordinal clinical rating scale developed to

assist in the clinical evaluation of people during the post acute (post hospital) period following

acquired brain injury (ABI), and to assist in the evaluation of rehabilitation programs designed to

serve these people. There are 35 individual questions, some with multiple parts, each with

specific text and matching numeric answers.

1. The scale points include a rating (e.g. 0; 1) and a definition of what is represented by the

rating (e.g. “None”; “Mild problem but does not interfere with activities; may use assistive

device or medication”). For Mayo-Portland Adaptability Inventory (MPAI-4), QSORRES

is populated with the text for the rating definition. The definition of the area being rated is

considered as a reference for the investigator to use in selecting a rating and is not

submitted in SDTM. The numeric values are populated in QSSTRESC and QSSTRESN.

a. Multiple rating definitions. Questions 1 through 20 use the same rating scale and

definitions. Questions 21 through 35 use the same scale, but with different definitions.

b. Multiple parts within an item. Question 28 has three parts. Question 28A is clearly

labeled. Questions 28B and 28C are both contained within question 28B on the

questionnaire. Either 28A or 28B is answered, not both. Question 28C is the primary

desired social role which is requested within 28B. Question 28 C will have Null

values for QSSTRESN as no numerical ratings are provided on the MPAI-4 for this

item. Item 28C is not used in determining the overall score. Note that if a subject is

considered to be retired, but they are not over 60 years old, then unemployed should be

indicated for question 28A (QSORRES=UNEMPLOYED; EMPLOYED LESS THAN

3 HRS/WK when QSTESTCD=MPAI128A) and records for questions 28B & 28C are

not created, since 28A is answered.

c. Questions 30 through 35 are each rated according to pre-injury and post-injury status.

For purposes of standardization, pre-injury will be considered as the item number

followed by ‘A’ (e.g. item ‘30A’ when item 30 is about the pre-injury status) and post-

injury will be considered as the item number followed by ‘B’ (e.g. item ‘30B’ when

item 30 is about the post-injury status).

2. There is a scoring worksheet for research analysts to use in determining an overall score

for the Mayo-Portland Adaptability Inventory (MPAI-4). This scoring is represented in

ADaM, not SDTM. The questions are divided into four parts which are indicated by

QSSCAT levels in SDTM – Part A (Abilities), Part B (Adjustment), Part C

(Participation), and Part D (Pre-existing and associated conditions). Analysts will rescore

items 4, 16, 27, 28A, and 28B. They will then determine subscale scores for each part.

Item 28C and Part D (Pre-existing and associated conditions) are excluded from the total

score. Analysts should refer to the complete Scoring Worksheet at the back of the

questionnaire for complete details. The MPAI-4 rating must be reliable, i.e., obtained

while the individual is not under the influence of anesthesia, other mind-altering drugs,

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recent seizure, or recovering from surgical anesthesia. Refer to the MPAI-4 rating form

and manual for further analysis details.

3. The evaluator of the questionnaire is stored in QSEVAL. As per the MPAI-4 manual, the

preference is for the evaluation to take place by professional consensus. If the entire

questionnaire is completed by the same evaluator or group of evaluators, then the

evaluator(s) will be indicated as per controlled terminology. However, there can be up to

four evaluators (one for each part, or QSSCAT level), including the subject or a

"SIGNIFICANT OTHER". If this is done, each evaluator completes only the section(s)

of the questionnaire (ex. QSSCAT level) they are responsible for, and the partially

completed questionnaires are then used together to create one complete

questionnaire. See Section 4 for alignment to the controlled terminology evaluator

codelist for QSEVAL. If SIGNIFICANT OTHER is selected, the specifics are listed in

QSEVALID.

4. Comments located at the end of the MPAI-4 will be recorded in the Comments domain

(CO). All assumptions and business rules described in the SDTMIG CO domain are

applicable.

5. Terminology:

a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology.

b. A full list of value sets for qualifier and result fields is provided in Section 4: SDTM

Mapping Strategy.

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3.2 Example for Mayo-Portland Adaptability Inventory (MPAI-4) QS Domain Model

The Mayo-Portland Adaptability Inventory (MPAI-4) example below shows the terminology used to implement the questionnaire in the QS domain.

This example shows the data for a subject collected at the baseline visit for a Mayo-Portland Adaptability Inventory (MPAI-4) questionnaire. The

example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. QSBLFL is Y based on VISITNUM=1. All original results

are represented with preferred terminology 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.

Rows 1-42: Shows the questions from the Mayo-Portland Adaptability Inventory (MPAI-4) CRF for one subject. As stated before, the preference is

for the evaluation to take place by professional consensus (QSEVAL=PROFESSIONAL CONSENSUS), however the example for subject P0001

has multiple evaluators. The evaluator for Part C (Rows 22-30) was the patient’s spouse, thus QSEVAL=SIGNIFICANT OTHER and

QSEVALID=SPOUSE.

Row 29: This row contains the answer for question 28A since it was answered. There is no data for questions 28B and 28C since they were not

answered.

Rows 31-42: Rows 31, 33, 35, 37, 39, and 41 represent the status of subject P0001 pre-injury for questions 30 through 35 on the MPAI-4. Rows

32, 34, 36, 38, 40, and 42 represent the status of P0001 post-injury for questions 30 through 35.

qs.xpt Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN

1 STUDYX QS P0001 1 MPAI101 MPAI1-Mobility MPAI-4 ABILITIES None 0 0

2 STUDYX QS P0001 2 MPAI102 MPAI1-Use of Hands MPAI-4 ABILITIES

Mild problem but does not interfere

with activities; may use assistive device or medication

1 1

3 STUDYX QS P0001 3 MPAI103 MPAI1-Vision MPAI-4 ABILITIES Mild problem; interferes with

activities 5-24% of the time 2 2

4 STUDYX QS P0001 4 MPAI104 MPAI1-Audition MPAI-4 ABILITIES Moderate problem; interferes with

activities 25-75% of the time 3 3

5 STUDYX QS P0001 5 MPAI105 MPAI1-Dizziness MPAI-4 ABILITIES Moderate problem; interferes with

activities 25-75% of the time 3 3

6 STUDYX QS P0001 6 MPAI106 MPAI1-Motor Speech MPAI-4 ABILITIES Moderate problem; interferes with

activities 25-75% of the time 3 3

7 STUDYX QS P0001 7 MPAI107A MPAI1-Verbal

Communication MPAI-4 ABILITIES

Severe problem; interferes with

activities more than 75% of the time 4 4

8 STUDYX QS P0001 8 MPAI107B MPAI1-Nonverbal

Communication MPAI-4 ABILITIES

Mild problem; interferes with activities 5-24% of the time

2 2

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Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN

9 STUDYX QS P0001 9 MPAI108 MPAI1-

Attention/Concentration MPAI-4 ABILITIES

Mild problem; interferes with activities 5-24% of the time

2 2

10 STUDYX QS P0001 10 MPAI109 MPAI1-Memory MPAI-4 ABILITIES Moderate problem; interferes with

activities 25-75% of the time 3 3

11 STUDYX QS P0001 11 MPAI110 MPAI1-Fund of

Information MPAI-4 ABILITIES

Severe problem; interferes with

activities more than 75% of the time 4 4

12 STUDYX QS P0001 12 MPAI111 MPAI1-Novel Problem-

Solving MPAI-4 ABILITIES

Severe problem; interferes with activities more than 75% of the time

4 4

13 STUDYX QS P0001 13 MPAI112 MPAI1-Visuospatial

Abilities MPAI-4 ABILITIES

Mild problem but does not interfere

with activities; may use assistive device or medication

1 1

14 STUDYX QS P0001 14 MPAI113 MPAI1-Anxiety MPAI-4 ADJUSTMENT Moderate problem; interferes with

activities 25-75% of the time 3 3

15 STUDYX QS P0001 15 MPAI114 MPAI1-Depression MPAI-4 ADJUSTMENT None 0 0

16 STUDYX QS P0001 16 MPAI115 MPAI1-Irritability, Anger,

Aggression MPAI-4 ADJUSTMENT

Moderate problem; interferes with

activities 25-75% of the time 3 3

17 STUDYX QS P0001 17 MPAI116 MPAI1-Pain and Headache MPAI-4 ADJUSTMENT Moderate problem; interferes with

activities 25-75% of the time 3 3

18 STUDYX QS P0001 18 MPAI117 MPAI1-Fatigue MPAI-4 ADJUSTMENT Mild problem; interferes with activities 5-24% of the time

2 2

19 STUDYX QS P0001 19 MPAI118 MPAI1-Sensitivity to Mild

Symptoms MPAI-4 ADJUSTMENT

Moderate problem; interferes with

activities 25-75% of the time 3 3

20 STUDYX QS P0001 20 MPAI119 MPAI1-Inappropriate

Social Interaction MPAI-4 ADJUSTMENT

Mild problem; interferes with

activities 5-24% of the time 2 2

21 STUDYX QS P0001 21 MPAI120 MPAI1-Impaired Self-

Awareness MPAI-4 ADJUSTMENT

Mild problem; interferes with activities 5-24% of the time

2 2

22 STUDYX QS P0001 22 MPAI121 MPAI1-Family/Significant

Relationships MPAI-4 ADJUSTMENT

Mild stress that interferes with

family functioning 5-24% of the time

2 2

23 STUDYX QS P0001 23 MPAI122 MPAI1-Initiation MPAI-4 PARTICIPATION None 0 0

24 STUDYX QS P0001 24 MPAI123 MPAI1-Social Contact-

Friends/Coworkers MPAI-4 PARTICIPATION

Moderately limited involvement with others (25-74% of normal

interaction for age)

3 3

25 STUDYX QS P0001 25 MPAI124 MPAI1-Leisure and

Recreation Activities MPAI-4 PARTICIPATION

Mildly limited participation (75-

95% of normal participation for age) 2 2

26 STUDYX QS P0001 26 MPAI125 MPAI1-Self-Care MPAI-4 PARTICIPATION

Mild difficulty, occasional omissions or mildly slowed

completion of self-care; may use

assistive device or require occasional prompting

1 1

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Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN

27 STUDYX QS P0001 27 MPAI126 MPAI1-Residence MPAI-4 PARTICIPATION Independent; living without

supervision or concern from others 0 0

28 STUDYX QS P0001 28 MPAI127 MPAI1-Transportation MPAI-4 PARTICIPATION

Independent in all modes of

transportation, but others have concerns about safety

1 1

29 STUDYX QS P0001 29 MPAI128A MPAI1-Paid Employment MPAI-4 PARTICIPATION Part-time (3 to 30 hrs/wk) without

support 1 1

30 STUDYX QS P0001 32 MPAI129 MPAI1-Managing Money

and Finances MPAI-4 PARTICIPATION

Requires a little help or supervision

(5-24% of the time) with large

finances; independent with small purchases

2 2

31 STUDYX QS P0001 33 MPAI130A MPAI1-Alcohol Use-Pre-

Injury MPAI-4

PRE-EXISTING AND

ASSOCIATED CONDITIONS

No or socially acceptable use 0 0

32 STUDYX QS P0001 34 MPAI130B MPAI1-Alcohol Use-Post-

Injury MPAI-4

PRE-EXISTING AND ASSOCIATED

CONDITIONS

Occasionally exceeds socially

acceptable use but does not interfere with everyday functioning; current

problem under treatment or in

remission

1 1

33 STUDYX QS P0001 35 MPAI131A MPAI1-Drug Use-Pre-

Injury MPAI-4

PRE-EXISTING AND

ASSOCIATED

CONDITIONS

No or occasional use 0 0

34 STUDYX QS P0001 36 MPAI131B MPAI1-Drug Use-Post-

Injury MPAI-4

PRE-EXISTING AND

ASSOCIATED

CONDITIONS

No or occasional use 0 0

35 STUDYX QS P0001 37 MPAI132A MPAI1-Psychotic

Symptoms-Pre-Injury MPAI-4

PRE-EXISTING AND

ASSOCIATED

CONDITIONS

None 0 0

36 STUDYX QS P0001 38 MPAI132B MPAI1-Psychotic

Symptoms-Post-Injury MPAI-4

PRE-EXISTING AND ASSOCIATED

CONDITIONS

Symptoms occasionally interfere

with everyday functioning but no

additional evaluation or treatment recommended

2 2

37 STUDYX QS P0001 39 MPAI133A MPAI1-Law Violations-

Pre-Injury MPAI-4

PRE-EXISTING AND

ASSOCIATED CONDITIONS

None or minor traffic violations

only 0 0

38 STUDYX QS P0001 40 MPAI133B MPAI1-Law Violations-

Post-Injury MPAI-4

PRE-EXISTING AND ASSOCIATED

CONDITIONS

None or minor traffic violations

only 0 0

39 STUDYX QS P0001 41 MPAI134A MPAI1-Other Physical

Cond-Pre-Injury MPAI-4

PRE-EXISTING AND ASSOCIATED

CONDITIONS

None 0 0

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Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN

40 STUDYX QS P0001 42 MPAI134B MPAI1-Other Physical

Cond-Post-Injury MPAI-4

PRE-EXISTING AND ASSOCIATED

CONDITIONS

Mild problem but does not interfere with activities; may use assistive

device or medication

1 1

41 STUDYX QS P0001 43 MPAI135A MPAI1-Other Cognitive

Cond-Pre-Injury MPAI-4

PRE-EXISTING AND ASSOCIATED

CONDITIONS

None 0 0

42 STUDYX QS P0001 44 MPAI135B MPAI1-Other Cognitive

Cond-Post-Injury MPAI-4

PRE-EXISTING AND ASSOCIATED

CONDITIONS

None 0 0

Row QSBLFL QSEVAL QSEVALID VISITNUM QSDTC

1 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

2 (cont) Y HEALTH CARE PROFESSIONAL

1 2014-11-16

3 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

4 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

5 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

6 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

7 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

8 (cont) Y HEALTH CARE PROFESSIONAL

1 2014-11-16

9 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

10 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

11 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

12 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

13 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

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Row QSBLFL QSEVAL QSEVALID VISITNUM QSDTC

14 (cont) Y HEALTH CARE PROFESSIONAL

1 2014-11-16

14 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

16 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

17 (cont) Y HEALTH CARE PROFESSIONAL

1 2014-11-16

18 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

19 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

20 (cont) Y HEALTH CARE PROFESSIONAL

1 2014-11-16

21 (cont) Y HEALTH CARE

PROFESSIONAL 1 2014-11-16

22 (cont) Y SIGNIFICANT OTHER SPOUSE 1 2014-11-16

23 (cont) Y SIGNIFICANT OTHER SPOUSE 1 2014-11-16

24 (cont) Y SIGNIFICANT OTHER SPOUSE 1 2014-11-16

25 (cont) Y SIGNIFICANT OTHER SPOUSE 1 2014-11-16

26 (cont) Y SIGNIFICANT OTHER SPOUSE 1 2014-11-16

27 (cont) Y SIGNIFICANT OTHER SPOUSE 1 2014-11-16

28 (cont) Y SIGNIFICANT OTHER SPOUSE 1 2014-11-16

29 (cont) Y SIGNIFICANT OTHER SPOUSE 1 2014-11-16

30 (cont) Y SIGNIFICANT OTHER SPOUSE 1 2014-11-16

31 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

32 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

33 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

34 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

35 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

36 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

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Row QSBLFL QSEVAL QSEVALID VISITNUM QSDTC

37 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

38 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

39 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

40 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

41 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

42 (cont) Y PROFESSIONAL

CONSENSUS 1 2014-11-16

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4 SDTM Mapping Strategy

Mayo-Portland Adaptability Inventory (MPAI-4) 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.

CRF Evaluator (QSEVAL) alignment to CDISC Controlled Terminology codelist (EVAL)

CRF Question: Person Reporting QSEVAL Single Professional HEALTH CARE PROFESSIONAL

Professional Consensus* PROFESSIONAL CONSENSUS

Person with brain injury STUDY SUBJECT

Significant other SIGNIFICANT OTHER

* MPAI-4 specific terminology

QSSCAT alignment with QSTESTCD

As stated in Assumption 2, the MPAI-4 CRF is grouped into sub-categories. The table below

includes the sub-category names along with the applicable question numbers for each category.

These values are used to populate QSSCAT and are annotated on the Case Report Form.

QSSCAT QSTESTCD

ABILITIES MPAI101 - MPAI112

ADJUSTMENT MPAI113 – MPAI121

PARTICIPATION MPAI122 – MPAI129 PRE-EXISTING AND ASSOCIATED CONDITIONS MPAI130A – MPAI135B

QSTESTCD=MPAI101 QSTEST=MPAI1-Mobility

QSTESTCD=MPAI102 QSTEST= MPAI1-Use of Hands

QSTESTCD=MPAI103 QSTEST= MPAI1-Vision

QSTESTCD=MPAI104 QSTEST= MPAI1-Audition

QSTESTCD=MPAI105 QSTEST= MPAI1-Dizziness

QSTESTCD=MPAI106 QSTEST= MPAI1-Motor Speech

QSTESTCD=MPAI107A QSTEST= MPAI1-Verbal Communication

QSTESTCD=MPAI107B QSTEST= MPAI1-Nonverbal Communication

QSTESTCD=MPAI108 QSTEST= MPAI1-Attention/Concentration

QSTESTCD=MPAI109 QSTEST= MPAI1-Memory

QSTESTCD=MPAI110 QSTEST= MPAI1-Fund of Information

QSTESTCD=MPAI111 QSTEST= MPAI1-Novel Problem-Solving

QSTESTCD=MPAI112 QSTEST= MPAI1-Visuospatial Abilities

QSTESTCD=MPAI113 QSTEST= MPAI1-Anxiety

QSTESTCD=MPAI114 QSTEST= MPAI1-Depression

QSTESTCD=MPAI115 QSTEST= MPAI1-Irritability, Anger, Aggression

QSTESTCD=MPAI116 QSTEST= MPAI1-Pain and Headache

QSTESTCD=MPAI117 QSTEST= MPAI1-Fatigue

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CDISC SDTM MPAI-4 Questionnaire Supplement (Version 1.0)

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QSTESTCD=MPAI118 QSTEST= MPAI1-Sensitivity to Mild Symptoms

QSTESTCD=MPAI119 QSTEST= MPAI1-Inappropriate Social Interaction

QSTESTCD=MPAI120 QSTEST= MPAI1-Impaired Self-Awareness

QSORRES QSSTRESC QSSTRESN None 0 0

Mild problem but does not interfere with activities; may use assistive device or

medication 1 1

Mild problem; interferes with activities 5-24% of the time 2 2

Moderate problem; interferes with activities 25-75% of the time 3 3

Severe problem; interferes with activities more than 75% of the time 4 4

QSTESTCD=MPAI121 QSTEST= MPAI1-Family/Significant Relationships

QSORRES QSSTRESC QSSTRESN Normal stress within family or other close network of relationships 0 0

Mild stress that does not interfere with family functioning 1 1

Mild stress that interferes with family functioning 5-24% of the time 2 2

Moderate stress that interferes with family functioning 25-75% of the time 3 3

Severe stress that interferes with family functioning more than 75% of the time 4 4

QSTESTCD=MPAI122 QSTEST= MPAI1-Initiation

QSORRES QSSTRESC QSSTRESN None 0 0

Mild problem but does not interfere with activities; may use assistive device or

medication 1 1

Mild problem; interferes with activities 5-24% of the time 2 2

Moderate problem; interferes with activities 25-75% of the time 3 3

Severe problem; interferes with activities more than 75% of the time 4 4

QSTESTCD=MPAI123 QSTEST= MPAI1-Social Contact-Friends/Coworkers

QSORRES QSSTRESC QSSTRESN Normal involvement with others 0 0

Mild difficulty in social situations but maintains normal involvement with others 1 1

Mildly limited involvement with others (75-95% of normal interaction for age) 2 2

Moderately limited involvement with others (25-74% of normal interaction for

age) 3 3

No or rare involvement with others (less than 25% of normal interaction for age) 4 4

QSTESTCD=MPAI124 QSTEST= MPAI1-Leisure and Recreational Activities

QSORRES QSSTRESC QSSTRESN Normal participation in leisure activities for age 0 0

Mild difficulty in these activities but maintains normal participation 1 1

Mildly limited participation (75-95% of normal participation for age) 2 2

Moderately limited participation (25-74% of normal participation for age) 3 3

No or rare participation (less than 25% of normal participation for age) 4 4

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CDISC SDTM MPAI-4 Questionnaire Supplement (Version 1.0)

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QSTESTCD=MPAI125 QSTEST= MPAI1-Self-Care

QSORRES QSSTRESC QSSTRESN Independent completion of self-care activities 0 0

Mild difficulty, occasional omissions or mildly slowed completion of self-care;

may use assistive device or require occasional prompting 1 1

Requires a little assistance or supervision from others (5-24% of the time)

including frequent prompting 2 2

Requires moderate assistance or supervision from others (25-75% of the time) 3 3

Requires extensive assistance or supervision from others (more than 75% of the

time) 4 4

QSTESTCD=MPAI126 QSTEST= MPAI1-Residence

QSORRES QSSTRESC QSSTRESN Independent; living without supervision or concern from others 0 0

Living without supervision but others have concerns about safety or managing

responsibilities 1 1

Requires a little assistance or supervision from others (5-24% of the time) 2 2

Requires moderate assistance or supervision from others (25-75% of the time) 3 3

Requires extensive assistance or supervision from others (more than 75% of the

time) 4 4

QSTESTCD=MPAI127 QSTEST= MPAI1-Transportation

QSORRES QSSTRESC QSSTRESN Independent in all modes of transportation including independent ability to operate

a personal motor vehicle 0 0

Independent in all modes of transportation, but others have concerns about safety 1 1

Requires a little assistance or supervision from others (5-24% of the time); cannot

drive 2 2

Requires moderate assistance or supervision from others (25-75% of the time);

cannot drive 3 3

Requires extensive assistance or supervision from others (more than 75% of the

time); cannot drive 4 4

QSTESTCD=MPAI128A QSTEST= MPAI1-Paid Employment

QSORRES QSSTRESC QSSTRESN Full-time (more than 30 hrs/wk) without support 0 0

Part-time (3 to 30 hrs/wk) without support 1 1

Full-time or part-time with support 2 2

Sheltered work 3 3

Unemployed; employed less than 3 hours per week 4 4

QSTESTCD=MPAI128B QSTEST= MPAI1-Other Employment

QSORRES QSSTRESC QSSTRESN Full-time (more than 30 hrs/wk) without support; full-time course load for students 0 0

Part-time (3 to 30 hrs/wk) without support 1 1

Full-time or part-time with support 2 2

Activities in a supervised environment other than a sheltered workshop 3 3

Inactive; involved in role-appropriate activities less than 3 hours per week 4 4

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CDISC SDTM MPAI-4 Questionnaire Supplement (Version 1.0)

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QSTESTCD=MPAI128C QSTEST= MPAI1-Other Employment-Social Role

QSORRES QSSTRESC Childrearing/care-giving Childrearing/care-giving

Homemaker, no childrearing or care-giving Homemaker, no childrearing or care-giving

Student Student

Volunteer Volunteer

Retired Retired

QSTESTCD=MPAI129 QSTEST= MPAI1-Managing Money and Finances

QSORRES QSSTRESC QSSTRESN Independent, manages small purchases and personal finances without supervision

or concern from others 0 0

Manages money independently but others have concerns about larger financial

decisions 1 1

Requires a little help or supervision (5-24% of the time) with large finances;

independent with small purchases 2 2

Requires moderate help or supervision (25-75% of the time) with large finances;

some help with small purchases 3 3

Requires extensive help or supervision (more than 75% of the time) with large

finances; frequent help with small purchases 4 4

QSTESTCD=MPAI130A QSTEST=MPAI1-Alcohol Use-Pre-Injury

QSTESTCD=MPAI130B QSTEST=MPAI1-Alcohol Use-Post-Injury

QSORRES QSSTRESC QSSTRESN No or socially acceptable use 0 0

Occasionally exceeds socially acceptable use but does not interfere with everyday

functioning; current problem under treatment or in remission 1 1

Frequent excessive use that occasionally interferes with everyday functioning;

possible dependence 2 2

Use or dependence interferes with everyday functioning, additional treatment

recommended 3 3

Inpatient or residential treatment required 4 4

QSTESTCD=MPAI131A QSTEST=MPAI1-Drug Use-Pre-Injury

QSTESTCD=MPAI131B QSTEST=MPAI1-Drug Use-Post-Injury

QSORRES QSSTRESC QSSTRESN No or occasional use 0 0

Occasional use does not interfere with everyday functioning; current problem

under treatment or in remission 1 1

Frequent excessive use that occasionally interferes with everyday functioning;

possible dependence 2 2

Use or dependence interferes with everyday functioning, additional treatment

recommended 3 3

Inpatient or residential treatment required 4 4

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CDISC SDTM MPAI-4 Questionnaire Supplement (Version 1.0)

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QSTESTCD=MPAI32A QSTEST=MPAI1-Psychotic Symptoms-Pre-Injury

QSTESTCD=MPAI32B QSTEST=MPAI1-Psychotic Symptoms-Post-Injury

QSORRES QSSTRESC QSSTRESN None 0 0

Current problem under treatment or in remission; symptoms do not interfere with

everyday functioning 1 1

Symptoms occasionally interfere with everyday functioning but no additional

evaluation or treatment recommended 2 2

Symptoms interfere with everyday functioning; additional treatment

recommended 3 3

Inpatient or residential treatment required 4 4

QSTESTCD=MPAI33A QSTEST=MPAI1-Law Violations-Pre-Injury

QSTESTCD=MPAI33B QSTEST=MPAI1-Law Violations-Post-Injury

QSORRES QSSTRESC QSSTRESN None or minor traffic violations only 0 0

Conviction on one or two misdemeanors other than minor traffic violations 1 1

History of more than two misdemeanors other than minor traffic violations 2 2

Single felony conviction 3 3

Repeat felony convictions 4 4

QSTESTCD=MPAI34A QSTEST=MPAI1-Other Physical Cond-Pre-Injury

QSTESTCD=MPAI34B QSTEST=MPAI1-Other Physical Cond-Post-Injury

QSTESTCD=MPAI35A QSTEST=MPAI1-Other Cognitive Cond-Pre-Injury

QSTESTCD=MPAI35B QSTEST=MPAI1-Other Cognitive Cond-Post-Injury

QSORRES QSSTRESC QSSTRESN None 0 0

Mild problem does not interfere with activities; may use assistive device or

medication 1 1

Mild problem; interferes with activities 5-24% of the time 2 2

Moderate problem; interferes with activities 25-75% of the time 3 3

Severe problem; interferes with activities more than 75% of the time 4 4

End of Document