NUPDRS3
Table Description:
Detailed notes for this table are included below.
1.0 Description: nUPDRS Part III
View Source CRFs
2.0 CRFs: Click on any PAG_NAME link below to be taken to a screenshot of how this eCRF is currently implemented in the PPMI 2.0 Study.
2.0 Data Dictionary
Table Constraints:
2.0 Code Book
ITM_NAME |
CODE |
DECODE_1.0 |
---|---|---|
DYSKIRAT |
0 |
No |
DYSKIRAT |
1 |
Yes |
DYSKPRES |
0 |
No |
DYSKPRES |
1 |
Yes |
PDSTATE |
1 |
Fluctuator - ON during exam |
PDSTATE |
3 |
Fluctuator - OFF during exam |
Missing Columns
ITM_NAME |
DSCR_1.0 |
---|---|
ANNUAL_TIME_BTW_DOSE_NUP |
Hours between dose and NUPDRS (max 99) |
DBS_STATUS |
0 = OFF, 1 = ON |
DYSKIRAT |
3.20 Did movements interfere with rating |
DYSKPRES |
3.19 Were dyskinesias present |
EXAMTM |
Time Part III was administered |
NHY |
3.21 Hoehn and Yahr Stage |
NP3BRADY |
3.14 Global spontaneity of movement |
NP3FACXP |
3.2 Facial expression |
NP3FRZGT |
3.11 Freezing of gait |
NP3FTAPL |
3.4b Finger Tapping Left Hand |
NP3FTAPR |
3.4a Finger Tapping Right Hand |
NP3GAIT |
3.10 Gait |
NP3HMOVL |
3.5b Hand movements - Left Hand |
NP3HMOVR |
3.5a Hand movements - Right Hand |
NP3KTRML |
3.16b Kinetic tremor - Left hand |
NP3KTRMR |
3.16a Kinetic tremor - Right hand |
NP3LGAGL |
3.8b Leg agility - Left leg |
NP3LGAGR |
3.8a Leg agility - Right leg |
NP3POSTR |
3.13 Posture |
NP3PRSPL |
3.6b Pronation-Supination - Left Hand |
NP3PRSPR |
3.6a Pronation-Supination - Right Hand |
NP3PSTBL |
3.12 Postural stability |
NP3PTRML |
3.15b Postural tremor - Left hand |
NP3PTRMR |
3.15a Postural tremor - Right Hand |
NP3RIGLL |
3.3e Rigidity - LLE |
NP3RIGLU |
3.3c Rigidity - LUE |
NP3RIGN |
3.3a Rigidity - Neck |
NP3RIGRU |
3.3b Rigidity - RUE |
NP3RISNG |
3.9 Arising from chair |
NP3RTALJ |
3.17e Rest tremor amplitude - Lip/jaw |
NP3RTALL |
3.17d Rest tremor amplitude - LLE |
NP3RTALU |
3.17b Rest tremor amplitude - LUE |
NP3RTARL |
3.17c Rest tremor amplitude - RLE |
NP3RTARU |
3.17a Rest tremor amplitude - RUE |
NP3RTCON |
3.18 Constancy of rest |
NP3SPCH |
3.1 Speech |
NP3TTAPL |
3.7b Toe tapping - Left foot |
NP3TTAPR |
3.7a Toe tapping - Right foot |
ON_OFF_DOSE |
PD Med None=” “,>=6 hr or PDSTATE OFF and >=3 hr=”1”,<6 hr=”2” |
PDMEDDT |
Date of most recent PD med dose |
PDMEDTM |
Time of most recent PD med dose |
PDSTATE |
Subject’s PD state during examination |
PD_MED_USE |
0=No,1=Lv,2=Ag,3=Oth,4=1+3,5=1+2,6=2+3,7=1+2+3 |
PN3RIGRL |
3.3d Rigidity - RLE |
STAFFCD |
Examiner |
Details
This table is a combination, in PPMI 2.0, of 3 CRFs: MDS UPDRS Part III (No Treatment), (OFF State), and (ON State)
. The CRF used for each record in this table is recorded in PAG_NAME
(not listed below since it is a standard variable present in all tables derived from CRFs). Users of the EDC decide which form to complete based on information captured in NUPDRDOSE (NUPDRDOSER
at remote visits):
Participants not taking a Levodopa-Equivalent treatment will complete the (No Treatment) CRF.
Participants being treated will ideally arrive to their annual visit in the OFF State (not having recently taken medication or not responding to their medication) and will complete the OFF State CRF.
Participants being treated will subsequently take their medication and complete the ON State CRF while in the ON State (having recently taken medication and responding well to it).
No source CRF is listed for PPMI 1.0 since the standard MDS-UPDRS Scale was used.
Definition of ON and OFF State
The definition of ON and OFF States have changed slightly from PPMI 1.0 to 2.0. In PPMI 1.0 more emphasis was put on marking a completed asssessment as having been in the ON or OFF state based on the time since a participant’s last dose of medication. In 2.0 the emphasis is more on a participant’s response to the treatment and while the time since last dose is recorded in NUPDRDOSE
, the ON or OFF State CRF is completed based on whether the participant is experiencing a treatment response at the time of the exam.
The PDTRTMNT
variable is collected in all of the NUPDRS3 forms and indicates whether the participant is being treated for Parkinson’s Disease. The PDSTATE
variable is asked in the ON and OFF NUPDRS3 forms and asks whether the particiapnt is ON or OFF of PD treatment, according to the above definition.
The HRPOSTMED
, HRDBSOFF
, and HRDBSON
variables indicate the amount of time between a change in treatment state (taking medication or turning on or off the DBS machine) and the NUPDRS3 exam. They are calculated by comparing PDMEDTM
(if PDMEDDT
is the same as INFODT
), DBSOFFTM
, or DBSONTM
to EXAMTM
, all of which are derived from information in the NUPDRDOSE form.
Remote Visits
At remote visits the MDS-UPDRS Part III is ideally not repeated as it is at annual visits. Participants being treated should be in the ON State. Since the assessment is not conducted in person, Rigidity (NP3RIGN
, NP3RIGRU
, NP3RIGLU
, NP3RIGRL
. and NP3RIGLL
) and Postural Stability (NP3PSTBL
) will be marked as “Unable to Rate”. The entire assessment will be skipped if the visit can only be conducted over the phone and without video.
In PPMI 1.0 the MDS-UPDRS Part III was not captured at remote (telephone) visits at all.
ITM_TYPE
ITM_TYPE
has changed for nearly every variable because in PPMI 2.0 the “Unable to Rate” option is captured in the list of possible values as “UR”, while in PPMI 1.0 only the numeric option 0-4 were listed.
NP3RIGRL
This variable is listed as ADDED because in PPMI 1.0 it was erroneously named PN3RIGRL
(listed here under Missing Columns).
Codebook
Besides DYSKIRAT
, no variables from the NUPDRS3 table were included in PPMI 1.0’s Code List. In 2.0, all variables from the NUPDRS3 table have been added to the codebook to allow for documentation on what the different codes mean for each question. The DIFF REASON of “DESIGN” indicates that these were added to the code book as a result of the design of the CRF in the EDC which includes both the numeric and text option.
NP3TOT
The total score is the sum of NP3SPCH
, NP3FACXP
, NP3RIGN
, NP3RIGRU
, NP3RIGLU
, PN3RIGRL
, NP3RIGLL
, NP3FTAPR
, NP3FTAPL
, NP3HMOVR
, NP3HMOVL
, NP3PRSPR
, NP3PRSPL
, NP3TTAPR
, NP3TTAPL
, NP3LGAGR
, NP3LGAGL
, NP3RISNG
, NP3GAIT
, NP3FRZGT
, NP3PSTBL
, NP3POSTR
, NP3BRADY
, NP3PTRMR
, NP3PTRML
, NP3KTRMR
, NP3KTRML
, NP3RTARU
, NP3RTALU
, NP3RTARL
, NP3RTALL
, NP3RTALJ
, and NP3RTCON
. It will not be computed if there are missing values in any of these columns. This includes all remote visits, where some questions will never be completed.