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.