unified parkinson's disease rating scale updrsportal.cdisc.org/questionnaire...

Unified Parkinson's Disease Rating Scale

UPDRS

Questionnaire Supplement to the Study Data

Tabulation Model Implementation Guide

for Human Clinical Trials

Prepared by

CDISC and National Institute of Neurological Disorders and Strokes (NINDS)

Notes to Readers

This implementation guide 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

2012-08-09 1.0 Unified Parkinson's Disease Rating Scale (UPDRS) Draft

2012-12-18 1.0 Unified Parkinson's Disease Rating Scale (UPDRS)

2014-06-12 1.1 Unified Parkinson's Disease Rating Scale (UPDRS)

Updated Controlled Terminology (Package 15).

Uppercased QSSCAT values.

Removed use of QSGRPID and combined with QSSCAT.

Update assumption 3 to include QSEVAL of STUDY

SUBJECT in addition to INVESTIGATOR.

Revised QSSTREC/QSSTRESN values for UPD143.

Updated annotations and document to current standards.

CDISC SDTM UPDRS Questionnaire Supplement (Version 1.1)

© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Final June 12, 2014

1 Introduction This document describes the CDISC implementation of the UPDRS questionnaire, a standard

questionnaire administered on a CRF that is typically used in clinical trials. UPDRS contains

data elements about non-motor and motor features of Parkinson's disease. (Examples of CDEs

included: Non-motor examination; Motor examination; etc.).

The UPDRS CRF preceded the CDISC CDASH CRF standards and based on its copyright

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 table, which can be found at the CDISC

website at http://www.cdisc.org/sdtm.

These implementation details for this specific questionnaire are meant to be used in conjunction

with the SDTMIG. All questionnaire documentation can be found on the CDISC web site

(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 CDISC has obtained permission to include the UPDRS questionnaire as part of CDISC Data

Standards. This means that CDISC developed QSTESTCD and QSTEST for each question based

on the actual question text on the questionnaire. The instrument itself was not changed.

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. This is a separate document bundled with the UPDRS

documentation.

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 Fahn S, Marsden CD, Calne DB, Goldstein M, eds. (Recent

Developments in Parkinson's Disease, Vol 2. Florham Park, NJ. Macmillan Health Care

http://www.cdisc.org/sdtm

http://www.cdisc.org/content2909

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

http://www.cdisc.org/terminology



Information 1987, pp 15 3-163, 293-30) for the agreement to include the UPDSR scale in the

CDISC data standards. Copyright information for the UPDRS scale is: the Movement

Disorder Society (MDS), All Right Reserved.

The author’s consent ensures that the data captured using this instrument will be done so in a

standardized manner thereby facilitating collection, database storage, reporting and regulatory

review of that data. CDISC wants to emphasize that the existing copyright status as well as the

existing procedures for licensing fees and using the instrument will remain exactly as they have

been. Please follow the instrument owner’s own mechanisms for permissions and licenses if you

have a need to use this questionnaire.

3 The QS Domain Model

3.1 Assumptions for the UPDRS Questionnaire Domain Model

All assumptions for the QS domain from the SDTMIG apply for this supplemental

implementation guide including those referenced in the CDISC notes. Additionally, the

following assumptions apply to the Unified Parkinson's Disease Rating Scale:

1. The Unified Parkinson's Disease Rating Scale (UPDRS): The UPDRS is a rating tool

to follow the longitudinal course of Parkinson's Disease, it has six sections: Part I

(evaluation of Mentation, behavior, and mood), Part II (self-evaluation of the

activities of daily life (ADLs) including speech, swallowing, handwriting, dressing,

hygiene, falling, salivating, turning in bed, walking, cutting food), Part III (clinician-

scored motor evaluation), Part IV (complications of therapy in the past week), Part V

(Hoehn and Yahr stating of severity of Parkinson’s disease), Part VI (Schwab and

England ADL scale). These are evaluated by interview. Some sections require

multiple grades assigned to each extremity. The QSSCAT values representing the six

sections can be found in Section 4: SDTM Mapping Strategy.

2. The time period of evaluation is populated in the QSEVLINT field in ISO 8601

format when the evaluation interval can be precisely described as duration. Specific

points in time should use the QSDTC field.

3. The evaluator of the questionnaire is stored in QSEVAL. Part II is the self-evaluation

of the daily life portion of the UPDRS in which QSEVAL = STUDY SUBJECT. For

the remainder of the UPDRS form, the Investigator provides the evaluations.

4. 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.

3.2 Example for the UNIFIED PARKINSON’S DISEASE RATING SCALE Domain Model

The UPDRS example below shows the terminology for QSCAT, QSTEST, QSTESTCD,

QSORRESU, QSSTRESU and standard values QSORRES, QSSTRESC and QSSTRESN that

should be utilized for this scale. Values for QSORRES are for prospective data collection.

Sponsors mapping legacy data should retain legacy values for QSORRES.

http://en.wikipedia.org/wiki/Hoehn_and_Yahr_scale

http://en.wikipedia.org/w/index.php?title=Schwab_and_England&action=edit&redlink=1

http://en.wikipedia.org/w/index.php?title=Schwab_and_England&action=edit&redlink=1

http://en.wikipedia.org/w/index.php?title=ADL_scale&action=edit&redlink=1



Example: The Unified Parkinson's Disease Rating Scale (UPDRS)

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

collected at one visit. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, QSCAT, QSORRESU and QSSTRESU. All original

results are represented with the preferred terminology in QSORRES. This result is then transformed into a standard numeric score in QSSTRESN and

character representation of the standard numeric score in QSSTRESC. QSEVLINT is only applicable to the section “IV. COMPLICATIONS OF

THERAPY”.

Rows 1-68: Represent the 68 questions from the UPDRS CRF. STUDYID=STUDY01, DOMAIN=QS, USUBJID=2324-P0001 and QSBLFL=Y are not

shown in the example due to the foot print of the table.

qs.xpt Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT

1 1 UPD101

UPD1-

Mentation:Intellectual

Impairment

UPDRS

I. MENTATION,

BEHAVIOR AND

MOOD

None 0 0 INVESTIGATOR 1

2 2 UPD102

UPD1-

Mentation:Thought

Disorder

UPDRS

I. MENTATION,

BEHAVIOR AND

MOOD

Vivid dreaming

1 1 INVESTIGATOR 1

3 3 UPD103 UPD1-

Mentation:Depression UPDRS

I. MENTATION,

BEHAVIOR AND

MOOD

Sustained

depression (1

week or more)

2 2 INVESTIGATOR 1

4 4 UPD104 UPD1-

Mentation:Motivation/Ini

tiative

UPDRS I. MENTATION,

BEHAVIOR AND

MOOD

Loss of initiative or

disinterest in

day to day (routine)

activities

3 3 INVESTIGATOR 1

5 5 UPD105 UPD1-Activities:Speech UPDRS

II. ACTIVITIES

OF DAILY

LIVING

Mildly affected. No

difficulty

being understood

1 1 STUDY

SUBJECT 1

6 6 UPD106 UPD1-

Activities:Salivation UPDRS

II. ACTIVITIES

OF DAILY

LIVING

Marked

excess of

saliva with some drooling

3 3 STUDY

SUBJECT 1

7 7 UPD107 UPD1-

Activities:Swallowing UPDRS

II. ACTIVITIES

OF DAILY LIVING

Occasional

choking 2 2

STUDY

SUBJECT 1

8 8 UPD108 UPD1-

Activities:Handwriting UPDRS

II. ACTIVITIES

OF DAILY

LIVING

The majority

of words are

not legible

4 4 STUDY

SUBJECT 1

9 9 UPD109 UPD1-Activities:Cut UPDRS II. ACTIVITIES Somewhat 1 1 STUDY 1



Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT

Food/Handle Utensil OF DAILY

LIVING

slow and

clumsy, but no help needed

SUBJECT

10 10 UPD110 UPD1-

Activities:Dressing UPDRS

II. ACTIVITIES

OF DAILY LIVING

Occasional

assistance with

buttoning,

getting arms in sleeves

2 2 STUDY

SUBJECT 1

11 11 UPD111 UPD1-Activities:Hygiene UPDRS

II. ACTIVITIES

OF DAILY

LIVING

Needs help to

shower or

bathe; or very

slow in

hygienic care

2 2 STUDY

SUBJECT 1

12 12 UPD112 UPD1-Activities:Turn

Bed/Adj Clothes UPDRS

II. ACTIVITIES

OF DAILY LIVING

Can initiate, but not turn or

adjust sheets

alone

3 3 STUDY

SUBJECT 1

13 13 UPD113 UPD1-Activities:Falling UPDRS II. ACTIVITIES

OF DAILY

LIVING

Rare falling 1 1 STUDY

SUBJECT 1

14 14 UPD114 UPD1-

Activities:Freezing When

Walking

UPDRS II. ACTIVITIES

OF DAILY

LIVING

Occasional freezing when

walking

2 2 STUDY

SUBJECT 1

15 15 UPD115 UPD1-Activities:Walking UPDRS II. ACTIVITIES

OF DAILY

LIVING

Mild

difficulty.

May not

swing arms or may tend to

drag leg

1 1 STUDY

SUBJECT 1

16 16 UPD116 UPD1-Activities:Tremor UPDRS

II. ACTIVITIES

OF DAILY LIVING

Slight and

infrequently present

1 1 STUDY

SUBJECT 1

17 17 UPD117 UPD1-Activities:Sensory

Complaints UPDRS

II. ACTIVITIES

OF DAILY LIVING

None 0 0 STUDY

SUBJECT 1

18 18 UPD118 UPD1-Motor:Speech UPDRS III. MOTOR

EXAMINATION

Marked

impairment,

difficult to

understand

3 3 INVESTIGATOR 1

19 19 UPD119 UPD1-Motor:Facial

Expression UPDRS

III. MOTOR

EXAMINATION

Masked or

fixed facies with severe or

complete loss

of facial expression;

lips parted 1/4

inch or more

4 4 INVESTIGATOR 1

20 20 UPD120A UPD1-Motor:Tremor at UPDRS III. MOTOR Mild in 2 2 INVESTIGATOR 1




Rest:Face Lips Chin EXAMINATION amplitude and

persistent. Or moderate in

amplitude, but

only intermittently

present

21 21 UPD120B UPD1-Motor:Tremor at

Rest:Hands: Right UPDRS

III. MOTOR

EXAMINATION

Marked in amplitude and

present most

of the time

4 4 INVESTIGATOR 1

22 22 UPD120C UPD1-Motor:Tremor at

Rest:Hands: Left UPDRS

III. MOTOR

EXAMINATION Absent 0 0 INVESTIGATOR 1

23 23 UPD120D UPD1-Motor:Tremor at

Rest:Feet: Right UPDRS

III. MOTOR

EXAMINATION

Slight and

infrequently present

1 1 INVESTIGATOR 1

24 24 UPD120E UPD1-Motor:Tremor at

Rest:Feet: Left UPDRS

III. MOTOR

EXAMINATION

Moderate in

amplitude and

present most of the time

3 3 INVESTIGATOR 1

25 25 UPD121A UPD1--Motor:Action

Tremor:Hand: Right UPDRS

III. MOTOR

EXAMINATION

Slight; present

with action 1 1 INVESTIGATOR 1

26 26 UPD121B UPD1--Motor:Action

Tremor:Hand: Left UPDRS

III. MOTOR EXAMINATION

Moderate in amplitude

with posture

holding as

well as action

3 3 INVESTIGATOR 1

27 27 UPD122A UPD1-Motor:Rigidity

Neck UPDRS

III. MOTOR

EXAMINATION

Mild to

moderate 2 2 INVESTIGATOR 1

28 28 UPD122B UPD1-Motor:Rigidity

Upper Extrem: Right UPDRS

III. MOTOR

EXAMINATION

Severe, range

of motion

achieved with difficulty

4 4 INVESTIGATOR 1

29 29 UPD122C UPD1-Motor:Rigidity

Upper Extrem: Left UPDRS

III. MOTOR

EXAMINATION

Marked, but

full range of

motion easily achieved

3 3 INVESTIGATOR 1

30 30 UPD122D UPD1-Motor:Rigidity

Lower Extrem: Right UPDRS

III. MOTOR

EXAMINATION

Slight or

detectable

only when

activated by

mirror or other movements

1 1 INVESTIGATOR 1

31 31 UPD122E UPD1-Motor:Rigidity

Lower Extrem: Left UPDRS

III. MOTOR

EXAMINATION Absent 0 0 INVESTIGATOR 1

32 32 UPD123A UPD1-Motor:Finger

Taps: Right UPDRS

III. MOTOR EXAMINATION

Normal 0 0 INVESTIGATOR 1

33 33 UPD123B UPD1-Motor:Finger

Taps: Left UPDRS

III. MOTOR

EXAMINATION

Moderately

impaired. 2 2 INVESTIGATOR 1




Definite and

early fatiguing. May

have

occasional arrests in

movement

34 34 UPD124A UPD1-Motor:Hand

Grips: Right UPDRS

III. MOTOR

EXAMINATION

Severely impaired.

Frequent

hesitation in initiating

movements or

arrests in ongoing

movement

3 3 INVESTIGATOR 1

35 35 UPD124B UPD1-Motor:Hand

Grips: Left UPDRS

III. MOTOR

EXAMINATION

Moderately

impaired. Definite and

early

fatiguing. May have

occasional

arrests in movement

2 2 INVESTIGATOR 1

36 36 UPD125A UPD1-Motor:Hand

Pronate/Supinate: Right UPDRS

III. MOTOR

EXAMINATION Normal 0 0 INVESTIGATOR 1

37 37 UPD125B UPD1-Motor:Hand

Pronate/Supinate: Left UPDRS

III. MOTOR

EXAMINATION

Mild slowing

and/or

reduction in amplitude

walking aid

1 1 INVESTIGATOR 1

38 38 UPD126A UPD1-Motor:Leg

Agility: Right UPDRS

III. MOTOR

EXAMINATION

Can barely

perform the task

4 4 INVESTIGATOR 1

39 39 UPD126B UPD1-Motor:Leg

Agility: Left UPDRS

III. MOTOR

EXAMINATION

Severely

impaired. Frequent

hesitation in

initiating movements or

arrests in

ongoing movement

3 3 INVESTIGATOR 1

40 40 UPD127 UPD1-Motor:Arising

from Chair UPDRS

III. MOTOR

EXAMINATION

Slow; or may

need more

than one attempt

1 1 INVESTIGATOR 1

41 41 UPD128 UPD1-Motor:Posture UPDRS III. MOTOR Moderately 2 2 INVESTIGATOR 1




EXAMINATION stooped

posture, definitely

abnormal; can

be slightly leaning to one

side

42 42 UPD129 UPD1-Motor:Gait UPDRS III. MOTOR

EXAMINATION

Severe disturbance of

gait, requiring

assistance.

3 3 INVESTIGATOR 1

43 43 UPD130 UPD1-Motor:Postural

Stability UPDRS

III. MOTOR

EXAMINATION

Absence of

postural

response;

would fall if not caught by

examiner

2 2 INVESTIGATOR 1

44 44 UPD131 UPD1-

Motor:Bradykinesia and

Hypokinesia

UPDRS III. MOTOR

EXAMINATION

Minimal slowness,

giving

movement a deliberate

character;

could be normal for

some persons.

Possibly reduced

amplitude

1 1 INVESTIGATOR 1

45 45 UPD132

UPD1-

Complications:Dyskinesias Duration

UPDRS

IV. COMPLICATION

S OF THERAPY -

A. DYSKINESIA

26-50% of day 2 2 INVESTIGATOR 1 -P1W

46 46 UPD133

UPD1-

Complications:Dyskinesias Disable

UPDRS

IV. COMPLICATION

S OF THERAPY -

A. DYSKINESIA

Moderately

disabling 2 2 INVESTIGATOR 1 -P1W

47 47 UPD134 UPD1-

Complications:Dyskinesi

as Painful

UPDRS

IV.

COMPLICATION

S OF THERAPY - A. DYSKINESIA

Slight 1 1 INVESTIGATOR 1 -P1W

48 48 UPD135 UPD1-

Complications:Dyskinesi

as Dystonia

UPDRS

IV.

COMPLICATION

S OF THERAPY - A. DYSKINESIA

No 0 0 INVESTIGATOR 1 -P1W

49 49 UPD136

UPD1-

Complications:Fluct

Predictable

UPDRS

IV.

COMPLICATIONS OF THERAPY -

B. CLINICAL

Yes 1 1 INVESTIGATOR 1 -P1W




FLUCTUATIONS

50 50 UPD137

UPD1-

Complications:Fluct

Unpredictable

UPDRS

IV. COMPLICATION

S OF THERAPY -

B. CLINICAL FLUCTUATIONS


51 51 UPD138

UPD1-

Complications:Fluct Suddenly

UPDRS

IV.

COMPLICATION

S OF THERAPY - B. CLINICAL

FLUCTUATIONS


52 52 UPD139

UPD1-

Complications:Fluct

Average

UPDRS

IV. COMPLICATION

S OF THERAPY -

B. CLINICAL FLUCTUATIONS

26-50% of day 2 2 INVESTIGATOR 1 -P1W

53 53 UPD140

UPD1-

Complications:Anorex

Nausea Vomit

UPDRS

IV.

COMPLICATION

S OF THERAPY - C. OTHER

COMPLICATION

S


54 54 UPD141

UPD1-

Complications:Insomnia

Hypersomnol

UPDRS

IV.

COMPLICATION

S OF THERAPY -

C. OTHER

COMPLICATION

S

Yes 1 1 INVESTIGATOR 1 -P1W

55 55 UPD142

UPD1-

Complications:Symptom

Orthostasis

UPDRS

IV.

COMPLICATION


COMPLICATION

S


56 56 UPD142A UPD1-Blood Pressure:

Seated UPDRS

IV. COMPLICATION

S OF THERAPY -

C. OTHER COMPLICATION

S

120/80 mmHg 120/80 mmHg INVESTIGATOR 1 -P1W

57 57 UPD142B UPD1-Blood Pressure:

Supine UPDRS

IV. COMPLICATION

S OF THERAPY -

C. OTHER COMPLICATION

S


58 58 UPD142C UPD1-Blood Pressure:

Standing UPDRS

IV.






C. OTHER

COMPLICATIONS

59 59 UPD142D UPD1-Weight UPDRS

IV.


C. OTHER

COMPLICATIONS

67 kg 67 67 kg INVESTIGATOR 1 -P1W

60 60 UPD142E UPD1-Pulse: Seated UPDRS

IV.

COMPLICATION

S OF THERAPY -

C. OTHER

COMPLICATION

S

55 BEATS/MIN 55 55 BEATS/MIN INVESTIGATOR 1 -P1W

61 61 UPD142F UPD1-Pulse: Standing UPDRS

IV.

COMPLICATION


COMPLICATION

S

57 BEATS/MIN 57 57 BEATS/MIN INVESTIGATOR 1 -P1W

62 62 UPD143 UPD1-Modified Hoehn

and Yahr Staging UPDRS

V. MODIFIED HOEHN AND

YAHR STAGING

Unilateral plus axial

involvement.

STAGE 1.5 INVESTIGATOR 1

63 63 UPD144A

UPD1-

Schwab/England % ADL

Score (PD)

UPDRS

VI. SCHWAB AND ENGLAND

ACTIVITIES OF

DAILY LIVING SCALE

Completely

independent in

most chores.

Takes twice as long.

Conscious of

difficulty and slowness

80 80 % INVESTIGATOR 1

64 64 UPD144B

UPD1-

Schwab/England % ADL

(Dyskinesia)

UPDRS

VI. SCHWAB AND ENGLAND

ACTIVITIES OF

DAILY LIVING SCALE

With effort,

now and then does a few

chores alone

or begins alone. Much

help needed

30 30 % INVESTIGATOR 1

65 65 UPD145

UPD1-Mentation,

Behavior, Mood Sub-Total

UPDRS

I. MENTATION,

BEHAVIOR AND MOOD

6 6 6 INVESTIGATOR 1

66 66 UPD146 UPD1-Activities Daily

Living Sub-Total UPDRS

II. ACTIVITIES

OF DAILY LIVING

23 23 23 INVESTIGATOR 1

67 67 UPD147 UPD1-Motor

Examination Sub-Total UPDRS

III. MOTOR

EXAMINATION 54 54 54 INVESTIGATOR 1

68 68 UPD148 UPD1-UPDRS Total UPDRS 83 83 83 INVESTIGATOR 1



4 SDTM Mapping Strategy UPDRS 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 QSSCAT and result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated for

the questionnaire. If a result variable is not included in the table for a questionnaire, it should not be populated.

QSTESTCD = UPD101 QSTEST = UPD1-Mentation:Intellectual Impairment

QSORRES QSSTRESC QSSTRESN

None 0 0 Mild. Consistent forgetfulness with partial recollection of events and no other

difficulties 1 1

Moderate memory loss, with disorientation and moderate difficulty handling

complex problems. Mild but definite impairment of function at home with need

of occasional prompting 2 2

Severe memory loss with disorientation for time and often to place. Severe

impairment in handling problems 3 3

Severe memory loss with orientation preserved to person only. Unable to make

judgements or solve problems. Requires much help with personal care. Cannot

be left alone at all 4 4

QSTESTCD = UPD102 QSTEST = UPD1-Mentation:Thought Disorder


None 0 0 Vivid dreaming 1 1

"Benign" hallucinations with insight retained 2 2 Occasional to frequent hallucinations or delusions; without insight; could

interfere with daily activities 3 3

Persistent hallucinations, delusions, or florrid psychosis. Not able to care for

self 4 4

QSTESTCD = UPD103 QSTEST = UPD1-Mentation:Depression


None 0 0 Periods of sadness or guilt greater than normal, never sustained for days or

weeks 1 1

Sustained depression (1 week or more) 2 2 Sustained depression with vegetative symptoms (insomnia, anorexia, weight

loss, loss of interest) 3 3

Sustained depression with vegetative symptoms and suicidal thoughts or intent 4 4

QSTESTCD = UPD104 QSTEST = UPD1-Mentation:Motivation/Initiative


Normal 0 0

Less assertive than usual; more passive 1 1

Loss of initiative or disinterest in elective (nonroutine) activities 2 2 Loss of initiative or disinterest in day to day (routine) activities 3 3

Withdrawn, complete loss of motivation 4 4



QSTESTCD = UPD105 QSTEST =UPD1-Activities:Speech


Normal 0 0

Mildly affected. No difficulty being understood 1 1

Moderately affected. Sometimes asked to repeat statements 2 2 Severely affected. Frequently asked to repeat statements 3 3

Unintelligible most of the time 4 4

QSTESTCD = UPD106 QSTEST = UPD1-Activities:Salivation


Normal 0 0

Slight but definite excess of saliva in mouth; may have nighttime drooling 1 1

Moderately excessive saliva; may have minimal drooling 2 2 Marked excess of saliva with some drooling 3 3

Marked drooling, requires constant tissue or handkerchief 4 4

QSTESTCD = UPD107 QSTEST = UPD1-Activities:Swallowing


Normal 0 0

Rare choking 1 1

Occasional choking 2 2

Requires soft food 3 3

Requires NG tube or gastrotomy feeding 4 4

QSTESTCD = UPD108 QSTEST = UPD1-Activities:Handwriting


Normal 0 0 Slightly slow or small 1 1

Moderately slow or small; all words are legible 2 2

Severely affected; not all words are legible 3 3

The majority of words are not legible 4 4

QSTESTCD = UPD109 QSTEST = UPD1-Activities:Cut Food/Handle Utensil

QSORRES QSSTRESC QSSTRESN Normal 0 0 Somewhat slow and clumsy, but no help needed 1 1

Can cut most foods, although clumsy and slow; some help needed 2 2

Food must be cut by someone, but can still feed slowly 3 3

Needs to be fed 4 4

QSTESTCD = UPD110 QSTEST = UPD1-Activities:Dressing

QSORRES QSSTRESC QSSTRESN Normal 0 0 Somewhat slow, but no help needed 1 1




Occasional assistance with buttoning, getting arms in sleeves 2 2

Considerable help required, but can do some things alone 3 3

Helpless 4 4

QSTESTCD = UPD111 QSTEST = UPD1-Activities:Hygiene


Normal 0 0

Somewhat slow, but no help needed 1 1

Needs help to shower or bathe; or very slow in hygienic care 2 2 Requires assistance for washing, brushing teeth, combing hair, going to

bathroom 3 3

Foley catheter or other mechanical aids 4 4

QSTESTCD = UPD112 QSTEST = UPD1-Activities:Turn Bed/Adj Clothes

QSORRES QSSTRESC QSSTRESN Normal. 0 0

Somewhat slow and clumsy, but no help needed 1 1

Can turn alone or adjust sheets, but with great difficulty 2 2

Can initiate, but not turn or adjust sheets alone 3 3

Helpless 4 4

QSTESTCD = UPD113 QSTEST = UPD1-Activities:Falling


None 0 0

Rare falling 1 1

Occasionally falls, less than once per day 2 2

Falls an average of once daily 3 3

Falls more than once daily 4 4

QSTESTCD = UPD114 QSTEST = UPD1-Activities:Freezing When Walking


None 0 0

Rare freezing when walking; may have starthesitation 1 1

Occasional freezing when walking 2 2

Frequent freezing. Occasionally falls from freezing 3 3

Frequent falls from freezing 4 4

QSTESTCD = UPD115 QSTEST = UPD1-Activities:Walking


Normal 0 0

Mild difficulty. May not swing arms or may tend to drag leg 1 1

Moderate difficulty, but requires little or no assistance 2 2

Severe disturbance of walking, requiring assistance 3 3 Cannot walk at all, even with assistance 4 4



QSTESTCD = UPD116 QSTEST = UPD1-Activities:Tremor


Absent 0 0

Slight and infrequently present 1 1

Moderate; bothersome to patient 2 2 Severe; interferes with many activities 3 3

Marked; interferes with most activities 4 4

QSTESTCD = UPD117 QSTEST = UPD1-Activities:Sensory Complaints


None 0 0

Occasionally has numbness, tingling, or mild aching 1 1

Frequently has numbness, tingling, or aching; not distressing 2 2 Frequent painful sensations 3 3

Excruciating pain 4 4

QSTESTCD = UPD118 QSTEST = UPD1-Motor:Speech


Normal 0 0

Slight loss of expression, diction and/or volume 1 1

Monotone, slurred but understandable; moderately impaired 2 2

Marked impairment, difficult to understand 3 3

Unintelligible 4 4

QSTESTCD = UPD119 QSTEST = UPD1-Motor:Facial Expression


Normal 0 0 Minimal hypomimia, could be normal "Poker Face" 1 1

Slight but definitely abnormal diminution of facial expression 2 2

Moderate hypomimia; lips parted some of the time 3 3 Masked or fixed facies with severe or complete loss of facial expression; lips

parted 1/4 inch or more 4 4

QSTESTCD = UPD120A QSTEST =UPD1-Motor:Tremor at Rest:Face Lips Chin

QSTESTCD = UPD120B QSTEST =UPD1-Motor:Tremor at Rest:Hands: Right

QSTESTCD = UPD120C QSTEST =UPD1-Motor:Tremor at Rest:Hands: Left

QSTESTCD = UPD120D QSTEST =UPD1-Motor:Tremor at Rest:Feet: Right

QSTESTCD = UPD120E QSTEST =UPD1-Motor:Tremor at Rest:Feet: Left


Absent 0 0

Slight and infrequently present 1 1 Mild in amplitude and persistent. Or moderate in amplitude, but only

intermittently present 2 2




Moderate in amplitude and present most of the time 3 3

Marked in amplitude and present most of the time 4 4

QSTESTCD = UPD121A QSTEST = UPD1--Motor:Action Tremor:Hand: Right

QSTESTCD = UPD121B QSTEST = UPD1--Motor:Action Tremor:Hand: Left


Absent 0 0

Slight; present with action 1 1

Moderate in amplitude, present with action 2 2

Moderate in amplitude with posture holding as well as action 3 3

Marked in amplitude; interferes with feeding 4 4

QSTESTCD = UPD122A QSTEST = UPD1-Motor:Rigidity Neck

QSTESTCD = UPD122B QSTEST = UPD1-Motor:Rigidity Upper Extrem: Right

QSTESTCD = UPD122C QSTEST = UPD1-Motor:Rigidity Upper Extrem: Left

QSTESTCD = UPD122E QSTEST = UPD1-Motor:Rigidity Lower Extrem: Right

QSTESTCD = UPD122F QSTEST = UPD1-Motor:Rigidity Lower Extrem: Left


Absent 0 0

Slight or detectable only when activated by mirror or other movements 1 1

Mild to moderate 2 2

Marked, but full range of motion easily achieved 3 3

Severe, range of motion achieved with difficulty 4 4

QSTESTCD = UPD123A QSTEST = UPD1-Motor:Finger Taps: Right

QSTESTCD = UPD123B QSTEST = UPD1-Motor:Finger Taps: Left


Norma 0 0

Mild slowing and/or reduction in amplitude 1 1 Moderately impaired. Definite and early fatiguing. May have occasional arrests

in movement 2 2

Severely impaired. Frequent hesitation in initiating movements or arrests in

ongoing movement 3 3

Can barely perform the task 4 4

QSTESTCD = UPD124A QSTEST = UPD1-Motor:Hand Grips: Right

QSTESTCD = UPD124B QSTEST = UPD1-Motor:Hand Grips: Left


Normal 0 0


in movement 2 2






QSTESTCD = UPD125A QSTEST = UPD1-Motor:Hand Pronate/Supinate: Right

QSTESTCD = UPD125B QSTEST = UPD1-Motor:Hand Pronate/Supinate: Left


Normal 0 0


in movement 2 2




QSTESTCD = UPD126A QSTEST = UPD1-Motor:Leg Agility: Right

QSTESTCD = UPD126B QSTEST = UPD1-Motor:Leg Agility: Left

QSORRES QSSTRESC QSSTRESN Normal 0 0 Mild slowing and/or reduction in amplitude 1 1 Moderately impaired. Definite and early fatiguing. May have occasional arrests

in movement 2 2




QSTESTCD = UPD127 QSTEST = UPD1-Motor:Arising from Chair


Normal 0 0

Slow; or may need more than one attempt 1 1

Pushes self up from arms of seat 2 2 Tends to fall back and may have to try more than one time, but can get up

without help 3 3

Unable to arise without help 4 4

QSTESTCD = UPD128 QSTEST = UPD1-Motor:Posture

QSORRES QSSTRESC QSSTRESN Normal erect 1 1

Not quite erect, slightly stooped posture; could be normal for older person 0 0 Moderately stooped posture, definitely abnormal; can be slightly leaning to one

side 2 2

Severely stooped posture with kyphosis; can be moderately leaning to one side 3 3

Marked flexion with extreme abnormality of posture 4 4

QSTESTCD = UPD129 QSTEST = UPD1-Motor:Gait


Normal 0 0 Walks slowly, may shuffle with short steps, but no festination (hastening steps)

or propulsion 1 1

Walks with difficulty, but requires little or no assistance; may have some

festination, short steps, or propulsion 2 2

Severe disturbance of gait, requiring assistance 3 3




Cannot walk at all, even with assistance 4 4

QSTESTCD = UPD130 QSTEST = UPD1-Motor:Postural Stability

QSORRES QSSTRESC QSSTRESN Normal 0 0

Retropulsion, but recovers unaided 1 1

Absence of postural response; would fall if not caught by examiner 2 2

Very unstable, tends to lose balance spontaneously 3 3

Unable to stand without assistance 4 4

QSTESTCD = UPD131 QSTEST = UPD1-Motor:Bradykinesia and Hypokinesia

QSORRES QSSTRESC QSSTRESN None 0 0 Minimal slowness, giving movement a deliberate character; could be normal

for some persons. Possibly reduced amplitude 1 1

Mild degree of slowness and poverty of movement which is definitely

abnormal. Alternatively, some reduced amplitude 2 2

Moderate slowness, poverty or small amplitude of movement 3 3 Marked slowness, poverty or small amplitude of movement 4 4

QSTESTCD = UPD132 QSTEST = UPD1-Complications:Dyskinesias Duration


None 0 0

1-25% of day 1 1

26-50% of day 2 2 51-75% of day 3 3 76-100% of day 4 4

QSTESTCD = UPD133 QSTEST = UPD1-Complications:Dyskinesias Disable


Not disabling 0 0

Mildly disabling 1 1

Moderately disabling 2 2 Severely disabling 3 3

Completely disabled 4 4

QSTESTCD= UPD134 QSTEST = UPD1-Complications:Dyskinesias Painful


No painful dyskinesias 0 0

Slight 1 1

Moderate 2 2

Severe 3 3

Marked 4 4

QSTESTCD = UPD135 QSTEST = UPD1-Complications:Dyskinesias Dystonia



QSTESTCD = UPD136 QSTEST = UPD1-Complications:Fluct Predictable

QSTESTCD = UPD137 QSTEST = UPD1-Complications:Fluct Unpredictable

QSTESTCD = UPD138 QSTEST = UPD1-Complications:Fluct Suddenly


No 0 0

Yes 1 1

QSTESTCD = UPD139 QSTEST = UPD1-Complications:Fluct Average

QSORRES QSSTRESC QSSTRESN None 0 0

1-25% of day 1 1

26-50% of day 2 2

51-75% of day 3 3

76-100% of day 4 4

QSTESTCD = UPD140 QSTEST = UPD1-Complications:Anorex Nausea Vomit

QSTESTCD = UPD141 QSTEST = UPD1-Complications:Insomnia Hypersomnol

QSTESTCD = UPD142 QSTEST = UPD1-Complications:Symptom Orthostasis


No 0 0

Yes 1 1

QSTESTCD = UPD143 QSTEST = UPD1-Modified Hoehn and Yahr Staging

QSORRES QSSTRESC

No signs of disease STAGE 0 Unilateral disease STAGE 1 Unilateral plus axial involvement STAGE 1.5

Bilateral disease, without impairment of balance STAGE 2

Mild bilateral disease, with recovery on pull test STAGE 2.5

Mild to moderate bilateral disease; some postural instability; physically independent STAGE 3

Severe disability; still able to walk or stand unassisted STAGE 4 Wheelchair bound or bedridden unless aided STAGE 5



QSTESTCD = UPD144A QSTEST = UPD1-Schwab/England % ADL Score (PD)

QSTESTCD = UPD144B QSTEST = UPD1-Schwab/England % ADL (Dyskinesia) QSORRES QSSTRESC QSSTRESN QSSTRESU

Completely independent. Able to do all chores without slowness, difficulty or impairment.

Essentially normal. Unaware of any difficulty 100 100 %

Completely independent. Able to do all chores with some degree of slowness, difficulty and

impairment. Might take twice as long. Beginning to be aware of difficulty 90 90 %

Completely independent in most chores. Takes twice as long. Conscious of difficulty and

slowness. 80 80 %

Not completely independent. More difficulty with some chores. Three to four times as long in

some. Must spend a large part of the day with chores 70 70 %

Some dependency. Can do most chores, but exceedingly slowly and with much effort. Errors;

some impossible 60 60 %

More dependent. Help with half, slower, etc. Difficulty with everything 50 50 %

Very dependent. Can assist with all chores, but few alone 40 40 %

With effort, now and then does a few chores alone or begins alone. Much help needed 30 30 %

Nothing alone. Can be a slight help with some chores. Severe invalid 20 20 %

Totally dependent, helpless. Complete invalid 10 10 %

Vegetative functions such as swallowing, bladder and bowel functions are not functioning.

Bedridden 0 0 %

As stated in Assumption 1, the UPDRS is grouped into categories. The table below includes the 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

I. MENTATION, BEHAVIOR AND MOOD UPD101 - UPD104

II. ACTIVITIES OF DAILY LIVING UPD105 – UPD117

III. MOTOR EXAMINATION UPD118 – UPD131

IV. COMPLICATIONS OF THERAPY - A. DYSKINESIA UPD132 – UPD135 IV. COMPLICATIONS OF THERAPY - B. CLINICAL FLUCTUATIONS UPD136 – UPD139 IV. COMPLICATIONS OF THERAPY - C. OTHER COMPLICATIONS UPD140 – UPD142F

V. MODIFIED HOEHN AND YAHR STAGING UPD143

VI. SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE UPD144A – UPD144B

I. MENTATION, BEHAVIOR AND MOOD UPD145

II. ACTIVITIES OF DAILY LIVING UPD146 III. MOTOR EXAMINATION UPD147

End of Document

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