NUPDRDOSE

Table Description: MDS-UPDRS Part III ON/OFF Determination & Dosing

Detailed notes for this table are included below.

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: PATNO, VISIT_ID

ITM_NAME

DSCR

ITM_TYPE

PDMEDYN

Is participant on medication for PD?

BOOLEAN

DBSYN

Does participant have DBS

BOOLEAN

ONOFFORDER

First Part III exam OFF or ON

NUMBER

OFFEXAM

OFF exam performed

BOOLEAN

OFFNORSN

Reason OFF exam not performed

NUMBER

OFFNORNCM

Other OFF exam not performed comment

TEXT

OFFPDMEDDT

Date of most recent PD med dose before OFF exam

DATE

OFFPDMEDTM

Time of most recent PD med dose before OFF exam

TIME

DBSOFFTM

Time DBS turned off before OFF exam

TIME

OFFEXAMTM

Time OFF exam was administered

TIME

ONEXAM

ON exam performed

BOOLEAN

ONNORSN

Reason ON exam not performed

NUMBER

ONNORNCM

Other ON exam not performed comment

TEXT

ONPDMEDDT

Date of most recent PD med dose before ON exam

DATE

ONPDMEDTM

Time of most recent PD med dose before ON exam

TIME

DBSONTM

Time DBS turned on before ON exam

TIME

ONEXAMTM

Time ON exam was administered

TIME

RMEXAM

MDS-UPDRS Part III examination administered at remote visit

BOOLEAN

RMNOPRT3

Reason MDS-UPDRS Part III examination not administered at remote visit

NUMBER

RMNOPRT3CM

Other reason MDS-UPDRS Part III examination not administered at remote visit comment

TEXT

RMONOFF

MDS-UPDRS part III will be ON or OFF at remote visit

NUMBER

RMTOFFRSN

Reason OFF exam performed at remote visit

NUMBER

RMTOFFRSNCM

Other reason OFF exam performed at remote visit comment

TEXT

2.0 Code Book

ITM_NAME

CODE

DECODE_2.0

DBSYN

0

No

DBSYN

1

Yes

OFFEXAM

0

No

OFFEXAM

1

Yes

OFFNORSN

1

Disease severity preventing participant from staying off medications/turning off DBS

OFFNORSN

2

Participant did not bring medication to clinic to turn ON

OFFNORSN

3

Participant forgot to refrain from taking medications and cannot stay long enough to reverse the order of testing

OFFNORSN

4

Participant does not feel comfortable turning off DBS

OFFNORSN

5

Participant/Site forgot to turn off DBS

OFFNORSN

6

Participant forgot to bring DBS remote to visit

OFFNORSN

7

Investigator was unable to determine if participant was fully OFF (extended release medication formulations, etc.)

OFFNORSN

8

Site scheduling issues during completion of visit

OFFNORSN

9

Other reason

ONEXAM

0

No

ONEXAM

1

Yes

ONNORSN

1

Typical ON state was not reached

ONNORSN

2

Scheduling issues

ONNORSN

3

Other reason

ONOFFORDER

1

OFF

ONOFFORDER

2

ON

PDMEDYN

0

No

PDMEDYN

1

Yes

RMEXAM

0

No

RMEXAM

1

Yes

RMNOPRT3

1

Visit was not conducted with video

RMNOPRT3

2

Scheduling issues

RMNOPRT3

3

Other reason

RMONOFF

1

OFF

RMONOFF

2

ON

RMTOFFRSN

1

Typical ON state was not reached

RMTOFFRSN

2

Scheduling issues

RMTOFFRSN

3

Other reason

Details

This form was added in PPMI 2.0 to assist in the MDS-UPDRS Part III workflow. Its purpose is to direct users to the correct Part III forms, and to properly document the medication context for those forms. See NUPDRS3 for details on how it should be repeated.

An alternate version of this form (PAG_NAME is NUPDRDOSER) is used at Remote visits. Details on how the MDS-UPDRS Part III should be collected can again be found in NUPDRS3.

Future State

This form will eventually be removed and its content will be integrated into the NUPDRS3 forms automatically as the As Needed functionality is improved.