VISSTAT

Table Description:

Detailed notes for this table are included below.

1.0 Description: Visit Status

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

ASSESCMP

0

No

ASSESCMP

1

Yes

ASSESTYP

1

In person

ASSESTYP

2

By phone

CGASTYP

1

In person

CGASTYP

2

By phone

CGINPUT

0

No

CGINPUT

1

Yes

EXCMEDYN

0

No

EXCMEDYN

1

Yes

LGAE2

1

Updated log at this visit

LGAE2

2

No data updates, log not blank

LGAE2

3

No events reported, log is blank

LGCMED2

1

Updated log at this visit

LGCMED2

2

No data updates, log not blank

LGCMED2

3

No con meds reported, log is blank

LGCONDTN

1

Updated log at this visit

LGCONDTN

2

No data updates, log not blank

LGCONDTN

3

No med conditions reported, log is blank

LGFAMHX

1

Updated log at this visit

LGFAMHX

2

No data updates, log not blank

LGFAMHX

3

No family history reported, log is blank

VISCMPLT

0

No

VISCMPLT

1

Yes

VISMSRSN

1

Scheduling issue with the subject

VISMSRSN

2

Scheduling issue with the staff.

VISMSRSN

3

Family / Social issues with the subject.

VISMSRSN

4

Subject did not return phone calls

VISMSRSN

5

Travel Distance

VISMSRSN

6

Medical Problems

VISMSRSN

7

Military Duty

VISMSRSN

8

Financial Issues

VISMSRSN

9

Lost to Follow up

VISMSRSN

10

Other (specify)

VISMSRSN

11

Institutionalized

VISMSRSN

13

Replaced by Symptomatic Therapy Visit

VSBYCOCO

0

No

VSBYCOCO

1

Yes

VSBYCOOR

0

No

VSBYCOOR

1

Yes

VSBYINV

0

No

VSBYINV

1

Yes

VSBYSUBI

0

No

VSBYSUBI

1

Yes

Missing Columns

ITM_NAME

DSCR_1.0

ASSESCMP

Were all assessments for visit completed

ASSESTYP

Assessments performed 1=in per, 2=phone

CGASTYP

Caregiver input 1=in person, 2=phone

CGINPUT

Caregiver input obtained

COMM

Comments

EXCMEDYN

Advised excl meds is a withdrawal

LGAE2

Reviewed AE -2

LGCMED2

Reviewed ConMed -2

LGCONDTN

Reviewed Med Conditions

LGFAMHX

Reviewed Family History

VISCMPLT

Visit Completed

VISMSCM

Visit Missed Reason Comment

VISMSRSN

Visit Missed Reason

VSBYCOCO

Visit conducted by co-coordinator

VSBYCOOR

Visit conducted by coordinator

VSBYINV

Visit conducted by investigator

VSBYSUBI

Visit conducted by sub-investigator

Details

In PPMI 1.0, the VISSTAT table had no directly corresponding CRF, though many of the variables in the VISSTAT table had similarities to those captured in the SIG table (which did have an associated CRF). In PPMI 2.0, VISSTAT has a CRF associated with it, and the SIG table has been removed entirely from the schema.

The VISSTAT CRF directly captures the following: VISTYPE, VISOUC, VISOUCRSN, VISWW, VISOOWRSN, and VISOOWCM

EDC Metadata

The other variables that exist in the VISSTAT table (EVENT_START, EVENT_END, VISMSRSN, VISMSCM) are all collected through the metadata of the EDC system.

Out of Clinic Visits

VISOUC was added partway through the study on 2020/11/11. The “Out of Clinic” (5) option was removed from VISTYPE. To resolve difference between version of this form:

  • Previous “Out of Clinic” responses to VISTYPE are turned into “Yes” responses to VISOUC in processing prior to transfer to LONI.

  • Codes for VISTYPE are remapped to remove option 5 (out of clinic). Values of 5 are removed as described in the above point and values of 6 are changed to 5.

Overlap with SIG in 1.0

  • In 1.0, VISMSRSN and VISMSCM were collected through the SIG CRF (these variables also existed in 1.0’s VISSTAT table, though there was no associated VISSTAT CRF). These variables capture the reason a visit was missed, and any associated comments. These variables are also captured in 2.0, though they are captured through the EDC metadata (as stated above).

  • In 1.0, VISSTAT and VISSTCM were collected through the SIG CRF. VISSTAT collects information about when a visit was completed (e.g. out of window, unscheduled, etc.) and who completed it. VISSTCM collects any additional comments. In 2.0, the type of visit is largely captured through VISTYPE, and information on a visit’s out of window status is captured through VISOUCRSN.

  • The possible values in VISMSRSN have been harmonized to account for versions of the question that existed both in SIG in the original phase of PPMI and in VISSTAT in the extended phase. “Other” in the extended version has been recoded from 11 to 20 and a new code 11 was added to account for a possible value in the original version.

Other Removed Columns

Many additional variables that existed in PPMI 1.0 were removed from the VISSTAT table in PPMI 2.0. In many cases, this was done because the information captured by these variables was either redundant, or was removed to help simplify the table.