VISSTAT

Table Description: Visit Status

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

ITM_TYPE_1.0

VISTYPE

Visit type

NUMBER

VISOUC

Out of Clinic visit

BOOLEAN

VISOUCRSN

Reason for Out of Clinic visit

NUMBER

VISWW

Visit in window

BOOLEAN

VISOOWRSN

Reason for out of window visit

NUMBER

VISOOWCM

Other reason for out of window visit comment

TEXT

EVENT_START

Visit Start Date

DATE

EVENT_END

Visit End Date

DATE

VISMSRSN

Visit Missed Reason

NUMBER

CHAR

VISMSCM

Visit Missed Reason Comment

TEXT

CHAR

2.0 Code Book

ITM_NAME

CODE

DECODE_2.0

DECODE_1.0

VISMSRSN

1

Scheduling issue with participant/their caregiver

Scheduling issue with the subject

VISMSRSN

2

Scheduling issue with site staff

Scheduling issue with the staff.

VISMSRSN

3

Family/Social issues

Family / Social issues with the subject.

VISMSRSN

4

Participant did not return phone calls to schedule

Subject did not return phone calls

VISMSRSN

5

Transportation/travel issues

Travel Distance

VISMSRSN

6

Medical problems

Medical Problems

VISMSRSN

7

Military duty

Military Duty

VISMSRSN

8

Financial issues

Financial Issues

VISMSRSN

9

Hospitalized/Institutionalized

Lost to Follow up

VISMSRSN

10

Lost to follow-up

Other (specify)

VISMSRSN

11

Replaced by Symptomatic Therapy Visit

Institutionalized

VISMSRSN

12

Subject withdrawal

VISMSRSN

13

Replaced by Symptomatic Therapy Visit

VISMSRSN

20

Other

VISOOWRSN

1

Scheduling issue with participant/caregiver

VISOOWRSN

2

Scheduling issue with site

VISOOWRSN

3

Family/Social issues

VISOOWRSN

4

Could not contact participant within window

VISOOWRSN

5

Transportation/Travel issues

VISOOWRSN

6

Medical problems

VISOOWRSN

7

Military duty

VISOOWRSN

8

Financial issues

VISOOWRSN

9

Hospitalized/Institutionalized

VISOOWRSN

10

Other

VISOUC

0

No

VISOUC

1

Yes

VISOUCRSN

1

PD too advanced

VISOUCRSN

2

Due to other illness

VISOUCRSN

3

Family, Caregiver, or social issues

VISOUCRSN

4

Participant moved

VISOUCRSN

5

Transportation/Travel issues

VISOUCRSN

6

Hospitalized/Institutionalized

VISOUCRSN

7

Subject refused site visit

VISOUCRSN

8

Participant concern due to COVID-19

VISOUCRSN

9

Governmental restrictions due to COVID-19

VISOUCRSN

10

Site restrictions due to COVID-19

VISTYPE

1

Standard protocol visit

VISTYPE

2

Diagnostic visit

VISTYPE

3

Need for PD Therapy visit

VISTYPE

4

Premature Withdrawal visit

VISTYPE

5

Unscheduled visit

VISWW

0

No

VISWW

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

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.