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Template_id Disease Group Data Element The question as it Data Element
Category Name appears on a form or CRF Definition
2 Parkinsonism Family History Family history Family history of the subject does or
of parkinsonism present does not endorse a
parkinsonism absent list all affected family history of
members Parkinsonism on
clincian interview
2 Parkinsonism Specific Parkinsonism Primary clinical diagnosis The clinician indicates
diagnosis clinical (check one) parkinson's which kind of
diagnosis disease progressive Parkinsonism the
supranuclear palsy, subject has by
diffuse Lewy body choosing one of the
disease, Multiple system offered diagnoses or
atrophy, other, present writing in if best
absent diagnosis not offered
2 Parkinsonism Age at Onset Age at Onset age at symtom onset the age at which the
subject themselves
first noted symptoms
of Parkinsonism,
based on clinician
interview
2 Parkinsonism Signs Asymmetric asymmetric onset present the clinician indicates
suggestive of onset absent if the onset of the
PD diagnosis Parkinsonism was
asymetric (started on
one side, and/or was
worse on one side
than the other); ifso,
then present is
checked. If not, then
absent is indicated
2 Parkinsonism Signs Bradykinesis Bradykinesis present the clinician indicates
suggestive of absent whether or not
PD diagnosis bradykinesis is present
on examination of the
subject, or if "on" from
medication at time of
evaluation, whether
this has ever been
observed as a part of
the subject's clinical
syndrome
2 Parkinsonism Signs Activation Activation Tremor present the clinician indicates
suggestive of tremor absent whether or not
PD diagnosis activation tremor is
present on
examination of the
subject.
2 Parkinsonism Signs Resting resting tremor present the clinician indicates
suggestive of Tremor absent whether or not 4-6 Hz
PD diagnosis resting tremor is
present on
examination of the
subject, or if "on" from
medication at time of
evaluation, whether
this has ever been
observed as a part of
the subject's clinical
syndrome.
2 Parkinsonism Signs Postural Postural instability present the clinician indicates
suggestive of Instability absent whether or not
PD diagnosis postural instability on
pull test is present on
examination of the
subject. If the subject
cannot stand, then the
clinician indicates
whether this has ever
been observed as part
of the subject's clinical
syndrome.
2 Parkinsonism Signs Rigidity rigidity present absent the clinician indicates
suggestive of whether or not rigidity
PD diagnosis is present on
examination of the
subject, or if "on" from
medication at time of
evaluation, whether
this has ever been
observed as a part of
the subject's clinical
syndrome.
2 Parkinsonism Signs Gait difficulties Gait difficulties present the clinician indicates
suggestive of absent whether or not gait
PD diagnosis difficulties are present
on examination of the
subject. If the subject
cannot stand, then the
clinician indicates
whether this has ever
been observed as part
of the subject's clinical
syndrome.
2 Parkinsonism Signs Response to Marked response to anti- the clinician indicates
suggestive of Anti- parkinsonism therapy whether or not the
PD diagnosis Parkinsonism subject has had at
Therapy least a 70%
improvement in motor
symptoms on
dopaminergic therapy,
including l-dopa,
dopamine agonists,
COMT and dopamine
reuptake inhibitors or
enhancers.
2 Parkinsonism Signs history of history of strokes or the clinician indicates
sugestive of strokes or stepwise deterioration if the subject has a
another stepwise present absent history of stroke
diagnosis deterioration causing a stepwise
course in progression
of parkinsonism; ie,
does the subject have
vascular
parkinsonism.
2 Parkinsonism Signs history of head history of head injury with the clinician indicates
sugestive of injury with loss loss of consciousness if the subject has a
another of present absent history of head injury
diagnosis consciousnes (including due to
s boxing) leading to loss
of conciousness
lasting more than 4
minutes, or more than
3 times over their
lifetime; present
indicates that this has
occurred, absent
indicates this subject
has not had this occur.
2 Parkinsonism Signs history of history of encephalitis the clinician indicates
sugestive of encephalitis present absent if the subject has a
another history of encephalitis
diagnosis (infection of the brain
tissue, requiring
hospitalization).
2 Parkinsonism Signs oculogyric oculogyric crisis present the clinician indicates
sugestive of crisis absent if the subject has a
another history of oculogyric
diagnosis crisis spontaneously or
secondary (for
example due to illness
such as encephalitis or
medication induced
phenomenae).
2 Parkinsonism Signs neuroleptic neuroleptic treatment at the clinician indicates
sugestive of treatment at time of symptom onset whether or not the
another time of present absent subject was treated
diagnosis symptom with neuroleptics or
onset related anti-emetics
which cause
parkinsonism at the
time of the onset of
parkinsonian
symptoms.
2 Parkinsonism Signs sustained sustained remission the clinician indicates
sugestive of remission present absent whether or not on
another history or on
diagnosis longitudinal physical
examination, the
subject has had a
sustained remission of
the parkinsonism.
2 Parkinsonism Signs supranuclear gaze palsy present absent the clinician indicates
sugestive of gaze palsy whether or not on
another physical examination,
diagnosis the subject has a
supranuclear gaze
palsy.
2 Parkinsonism Signs cerebellar cerebellar signs present the clinician indicates
sugestive of signs (other absent whether or not on
another than activation physical examination,
diagnosis tremor) the subject has signs
of cerebellar
dysfunction, other than
activation tremor.
2 Parkinsonism Signs fluctuations fluctuations present the clinician indicates
sugestive of absent whether or not the
another subject has
diagnosis fluctuations in severity
of parkinsonism.
2 Parkinsonism Signs hallucinations hallucinations present the clinician indicates
sugestive of absent whether or not the
another subject has
diagnosis hallucinations either
independent of or
related to treatment for
parkinsonism.
2 Parkinsonism Signs dysautonomia dysautonomia present the clinician indicates
sugestive of absent whether or not the
another subject has
diagnosis dysautonomia,
including orthostatic
hypotension.
2 Parkinsonism Signs memory loss memory loss present the clinician indicates
sugestive of absent whether or not the
another subject has memory
diagnosis loss on history.
2 Parkinsonism Signs axial rigidity axial rigidity present the clinician indicates
sugestive of absent if rigidity exists axially
another on physical
diagnosis examination.
2 Parkinsonism Signs other other specify the clinician indicates,
sugestive of via comments, if they
another see other features
diagnosis suggestive of a
diagnosis other than
Parkinson's disease
which is not delineated
by the choices given.
2 Parkinsonism Optional data smoking smoking history current A record of an
history previous never individual's
background in regard
to smoking tobacco.
This would include
such factors as start
date, end date (if
applicable), number of
cigarette smoked,
attempts to quit, and
others.
2 Parkinsonism Optional data years smoking years smoking how many years did
the person smoke, if
the person is a current
or former smoker?
2 Parkinsonism Optional data Mini-mental min-mental status score The score on the
status score Folstein Mini-Mental
Status Score
2 Parkinsonism Optional data Hoehn and Hoehn and Yahr The score on the
Yahr Hoehn and Yahr scale
2 Parkinsonism Optional data UPDRS total UPDRS total score the score on the
motor score (indicate on/off) Unified Parkinson's
Disease Rating Scale
2 Parkinsonism Optional data Handedness handedness left right the hand preference of
ambidextrous the subject; the
subject's dominant
hand
Data type Enumerated Response Decimal High value (for Low value (for Permissible
(choice list) or Maximum places (for numeric data numeric data value on
Nonenumerat length numeric data type) type) choice list
ed? type)
varchar enumerated 225 present or
absent
varchar enumerated 225
varchar enumerated 225 2 120 0 0-120
varchar enumerated present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225
varchar enumerated 225
varchar enumerated 225
varchar enumerated 225
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 present or
absent
varchar enumerated 225 Current,
former, never
numeric nonenumerate 5 2 99 0 0-99
d
numeric nonenumerate 10 2 30 0 0-30 (or #/30)
d
numeric nonenumerate 10 2 5 1 1 through 5
d
numeric nonenumerate 10 3 0 0-199
d
varchar enumerated 225 right, left,
amibdextrous
Permisible value meaning Standard Source?
observed?
present indicates that the individual http://ncimeta.nci. MSH2005_2004_1
subject on clinician interview endorses nih.gov/indexMet 0_12
that there is a blood relative of that aphrase.html
subject who is known to have a history
or diagnosis of Parkinson's disease.
Absent indicates that they do not have a
known blood relative with this disorder.
if present, the clinician is to delineate
which blood relatives have this disorder
and their relationship to the proband.
the clinician chooses from the http://www.wemo http://www.wemov
enumerated list the diagnosis that best ve.org/glossary/, e.org/glossary/,
fits the subject at the time of the http://www.notting http://www.notting
interview. If there is no best fit, or the ham.ac.uk/pathol ham.ac.uk/patholo
diagnosis is not listed, the clinician ogy/lewy/lewyinfo. gy/lewy/lewyinfo.ht
writes this in as a comment. html ml
the number indicated is the age, in MSH2005_2004_ MSH2005_2004_1
years, of symptom onset, which the 10_12 0_12
subject themselves observe, based on
clinician interview
present indicates that the individual NCI2005_05
subject on examination has asymmetry,
with Parkinsonism worse on one side or
the other, or, if advanced, was the onset
asymetric based on clinician interview.
Absent indicates that the parkinsonism
affects both sides of the subjects body
equally.
present indicates that the individual Bradley et al. http://www.wemov
subject on examination has Neurology in e.org/bradykinesia
bradykinesis. Absent indicates that there Clinical Practice /
is no bradykinesis. If the subject is fully Vol I, p 319.
medicated and no bradykinesis is
observed on examination, then postive
can be chosen if bradykinesis has been
observed with the subject in the "off"
state. Absent indicates that
bradykinesis is not part of this subjects
clinical syndrome.
present indicates that the individual Bradley et al. http://www.wemov
subject on examination has activation Neurology in e.org/tremor/
(action, postural) tremor. Absent Clinical Practice
indicates that there is no activation Vol I, p 320-322.
tremor.
present indicates that the individual Bradley et al. http://www.wemov
subject on examination has 4-6 Hz Neurology in e.org/tremor/
resting tremor. Absent indicates that Clinical Practice
there is no bradykinesis. If the subject Vol I, p 320.
is fully medicated and no resting tremor
is observed on examination, then
postive can be chosen if resting tremor
has been observed with the subject in
the "off" state. Absent indicates that
resting tremor is not part of this subjects
clinical syndrome.
present indicates that the individual Bradley et al. http://www.parkins
subject on examination has postural Neurology in on.org/site/pp.asp
instability on "pull test". Absent indicates Clinical Practice ?c=9dJFJLPwB&b
that there is no postural instability. If the Vol I, p 319. =123510
subject cannot stand, the clinician
indicates if postural stability has ever
been observed on clinical examination;
it is has been observed, this is present;
if never observed, then this is absent.
present indicates that the individual Bradley et al. http://www.parkins
subject on examination has rigidity. Neurology in on.org/site/pp.asp
Absent indicates that there is no rigidity. Clinical Practice ?c=9dJFJLPwB&b
If the subject is fully medicated and no Vol I, p 318. =123510
rigidity is observed on examination, then
postive can be chosen if rigidity has
been observed with the subject in the
"off" state. Absent indicates that rigidity
is not part of this subjects clinical
syndrome.
present indicates that the individual O'Sullivan JD et http://www.parkins
subject on examination has gait al, Movement on.org/site/apps/s/
difficulties on physical examination. Disord content.asp?c=9d
Absent indicates that there is no gait 1998;13(6):900- JFJLPwB&b=1082
difficulty. 906. 69&ct=149794
present indicates that at some point in Muenter MD. http://www.findarti
their therapy, the subject has had at Pharmacotherapy cles.com/p/articles
least a 70% improvement in motor : problems and /mi_m3225/is_n2_
symptoms on some form of anti- practices.Clin v41/ai_8563173
parkinsonism therapy, including l-dopa, Neuropharmacol. (Alskog et al
dopamine agonists, COMT and 1986;9 Suppl American Family
dopamine reuptake inhibitors or 1:S23-36. Physician, 1990).
enhancers. Absent indicates that the
subject has never had a response to
any anti-parkinsonian therapy of any
detectable magnitude.
present indicates that the subject has Winikates and MSH2005_2004_1
had a series of strokes leading to Jankovic Arch 0_12
parkinsonism with a stepwise course of Neurol
deterioration. Absent indicates that the 1999;56:98-102.
course has not been stepwise related to
stroke.
present indicates that on clinical Adams et al., MSH2005_2004_1
interview the subject endorses a history Principles of 0_12
of head injury (including due to boxing) Neurology, 6th
leading to loss of conciousness lasting ed, pp344-355
more than 4 minutes, or more than 3 and 749-751.
times over their lifetime. Absent
indicates the subject has not had this
occur.
present indicates that on clinical Adams et al., MSH2005_2004_1
interview the subject endorses a history Principles of 0_12
of encephalitis at some point in their Neurology, 6th
lifetime absent indicates that on clinician ed, pp 650-656.
interview, the subject denies any history
or encephalitis.
present indicates that on clinical Adams et al., ICPC2ICD10ENG
interview the subject endorses a history Principles of _200403 MDR-60
of oculogyric crisis, as determined by Neurology, 6th SNOMEDCT_200
the clinician explaning this in terms that ed, p 230. 4_01_31
the patient can understand. absent
indicates that on interview, the subject
denies any history of oculogyric crisis.
present indicates that on clinical Bradley et al. MSH2005_2004_1
interview, the subject endorses that they Neurology in 0_12
were under treatment with neuroleptics Clinical Practice
or related anti-emetics at the time of or Vol I, p 318-319.
had treatment preceding the onset of
parkinsonism. Absent indicates no
history of neuroleptic or anti-emetic
induced parkinsonism.
present indicates that the clinician notes NCI2005_05 NCI2005_05
that on history or on longitudinal
physical examination, the subject has
had a sustained remission of the
parkinsonism. Absent indicates that on
interview and examination, there is no
remission of parkinsonism, but rather,
that the disorder in this subject is
progressive.
present indicates that the clinician notes Litvan et al. http://pspinformati
supranuclear gaze palsy on physical Neurology on.com/disease/p
examination. Absent indicates that 1996;119(pt sp/whatispsp.shtm
examination of the extraocular eye 3):831-839. l
movements has been done and no
supranuclear gaze palsy is observed.
present indicates that the clinician notes Gilman et al. Clin MSH2005_2004_1
cerebellar signs, excluding activation Auton Res 0_12
tremor on physical examination. Absent 1998;8:(6):359-
indicates that examination no cerebellar 362.
signs, or none except for activation
tremor.
present indicates that the subject has McKeith et al. http://www.notting
periods in which the parkinsonism is Consensus ham.ac.uk/patholo
dramatically worse, or dramatically guidelines for the gy/lewy/lewyinfo.ht
better, or, periods where any co-existent clinical and ml
dementia fluctuates. Absent indicates pathologic
that parkinsonism is gradually diagnosis of
progressive without fluctuations. dementia with
Lewy bodies
(DLB): report of
the consortium on
DLB international
workshop.
Neurology
1996;47:1113-
1124
present indicates that the subject or Bradley et al. MSH2005_2004_1
caregiver endorses that the subject Neurology in 0_12
suffers hallucinations. Absent indicates Clinical Practice
that the subject denies hallucinations. Vol I, p 92-95.
present indicates that the subject has Gilman et al. Clin MSH2005_2004_1
symptoms or signs of dysautonomia. Auton Res 0_12
Absent indicates that the subject does 1998;8:(6):359-
not have any symptoms or signs 362.
suggestive of dysautonomia.
present indicates that the subject has Bradley et al. CSP2004
memory loss based on clinical Neurology in
evaluation. If present, the clinician is Clinical Practice
encouraged to include a mini-mental Vol I, p 78-79.
status score. Absent indicates that the
clinician detects no evidence of memory
loss in the subject.
present indicates that the subject has Litvan et al. http://pspinformati
axial rigidity on clinical evaluation. Neurology on.com/disease/p
Absent indicates that there is no axial 1996;119(pt sp/whatispsp.shtm
rigidity on physical examination. 3):831-839. l
present indicates that there are features Litvan et al. Mov http://www.wemov
that the the clinician notes to be present Disord e.org/glossary/
which are indicative of a diagnosis other 2003;18(5):467-
than Parkinson's disease, and the 486. Hughes and
clinician indicates, via comments, the Lees. JNNP
specifics of these. Absent indicates the 1999;55:1;81-
clinician observes no other features 184.
suggestive of a diagnosis other than
Parkinson's disease.
Current indicates is a current smoker; http://ncimeta.nci. NCI05
former indicates the subject smoked in nih.gov/indexMet
the past but does not smoke now; never aphrase.html
indicates that the individual has never
smoked.
number of years smoked total http://ncimeta.nci. NCI05
nih.gov/indexMet
aphrase.html
the subject has a score on the Folstein Folstein. J n/a
Mini mental status exam as specified Psychiatr Res
1975;12:189-98
the subject has a score on the Hoehn Hoehn MM, Yahr http://www.parkins
and Yahr scale as specified MD. on.org/site/apps/s/
Parkinsonism: content.asp?c=9d
onset, JFJLPwB&b=1082
progression and 69&ct=149794
mortality.Neurolo
the subject has a score on the Unified gy. 1967 http://www.parkins
Parkinson's Disease Rating Scale as May;17(5):427- on.org/site/apps/s/
specified 42. content.asp?c=9d
JFJLPwB&b=1082
69&ct=149794
the subject has a right hand dominance MSH2005_2004_10_1
or preference if right is indicated; the 2:NCI 05
subject has a left hand preference or
dominance if left is indicated; the
indivdual uses either hand
interchangably and has no hand
preference if ambidextrous is chosen
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