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 Page 2 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
CDISC SDTM UPDRS Questionnaire Supplement (Version 1.1)
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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.
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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
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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
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Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT
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
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Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT
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
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Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT
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
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Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT
FLUCTUATIONS
50 50 UPD137
UPD1-
Complications:Fluct
Unpredictable
UPDRS
IV. COMPLICATION
S OF THERAPY -
B. CLINICAL FLUCTUATIONS
No 0 0 INVESTIGATOR 1 -P1W
51 51 UPD138
UPD1-
Complications:Fluct Suddenly
UPDRS
IV.
COMPLICATION
S OF THERAPY - B. CLINICAL
FLUCTUATIONS
No 0 0 INVESTIGATOR 1 -P1W
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
No 0 0 INVESTIGATOR 1 -P1W
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
S OF THERAPY - C. OTHER
COMPLICATION
S
No 0 0 INVESTIGATOR 1 -P1W
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
115/77 mmHg 115/77 mmHg INVESTIGATOR 1 -P1W
58 58 UPD142C UPD1-Blood Pressure:
Standing UPDRS
IV.
COMPLICATIONS OF THERAPY -
117/78 mmHg 117/78 mmHg INVESTIGATOR 1 -P1W
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Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT
C. OTHER
COMPLICATIONS
59 59 UPD142D UPD1-Weight UPDRS
IV.
COMPLICATIONS OF THERAPY -
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
S OF THERAPY - C. OTHER
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
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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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
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QSTESTCD = UPD105 QSTEST =UPD1-Activities:Speech
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
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QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
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QSTESTCD = UPD116 QSTEST = UPD1-Activities:Tremor
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
Absent 0 0
Slight and infrequently present 1 1 Mild in amplitude and persistent. Or moderate in amplitude, but only
intermittently present 2 2
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QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
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
Severely impaired. Frequent hesitation in initiating movements or arrests in
ongoing movement 3 3
Can barely perform the task 4 4
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QSTESTCD = UPD125A QSTEST = UPD1-Motor:Hand Pronate/Supinate: Right
QSTESTCD = UPD125B QSTEST = UPD1-Motor:Hand Pronate/Supinate: 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
Severely impaired. Frequent hesitation in initiating movements or arrests in
ongoing movement 3 3
Can barely perform the task 4 4
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
Severely impaired. Frequent hesitation in initiating movements or arrests in
ongoing movement 3 3
Can barely perform the task 4 4
QSTESTCD = UPD127 QSTEST = UPD1-Motor:Arising from Chair
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
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QSORRES QSSTRESC QSSTRESN
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
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 = UPD133 QSTEST = UPD1-Complications:Dyskinesias Disable
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
No painful dyskinesias 0 0
Slight 1 1
Moderate 2 2
Severe 3 3
Marked 4 4
QSTESTCD = UPD135 QSTEST = UPD1-Complications:Dyskinesias Dystonia
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QSTESTCD = UPD136 QSTEST = UPD1-Complications:Fluct Predictable
QSTESTCD = UPD137 QSTEST = UPD1-Complications:Fluct Unpredictable
QSTESTCD = UPD138 QSTEST = UPD1-Complications:Fluct Suddenly
QSORRES QSSTRESC QSSTRESN
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
QSORRES QSSTRESC QSSTRESN
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
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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