PROELIG¶
Table Description: Prodromal Cohort Eligibility
Detailed notes for this table are included below.
2.0 Data Dictionary¶
Table Constraints: PATNO, VISIT_ID
ITM_NAME |
DSCR |
ITM_TYPE |
|---|---|---|
UPSITENRL_FORMVER |
Version of the UPSIT that was administered |
NUMBER |
UPSITENRL_TOTAL_CORRECT |
Enrollment UPSIT Total Correct Items 0 - 40 REVISED scores are adjusted according to UPSITENRL_ADJVER |
NUMBER |
UPSITENRL_ADJVER |
Version of the Enrollment UPSIT - REVISED Total Score Adjustment for Eligibility - Date received |
TEXT |
UPSITENRL_PRCNTGE |
Enrollment UPSIT Percentage 0 - 100 |
NUMBER |
UPSITENRL_PRCTVER |
Version of the Enrollment UPSIT Percentile Lookup - Date received |
TEXT |
UPSITENRL_ELIGBL |
Prodromal participant was eligible at enrollment for participation in PPMI 2.0 based on UPSIT percentile |
BOOLEAN |
UPSITENRL_ELIGWAIV |
Waiver applied to override disqualifying UPSIT percentile and make prodromal participant eligible at enrollment |
BOOLEAN |
2.0 Code Book¶
ITM_NAME |
CODE |
DECODE_2.0 |
|---|---|---|
UPSITENRL_ELIGBL |
0 |
No |
UPSITENRL_ELIGBL |
1 |
Yes |
UPSITENRL_ELIGWAIV |
0 |
No |
UPSITENRL_ELIGWAIV |
1 |
Yes |
UPSITENRL_FORMVER |
1 |
Original |
UPSITENRL_FORMVER |
2 |
Revised |
Details¶
This table is meant to capture metadata around eligibility for prodromal participants. While variables are derived from data captured in other tables, this table is not associated with a single CRF.
UPSIT Variables
The UPSIT assessment is collected for non-remote prodromal participants at Screening. The indivdiual items are captured in the UPSIT table. The results of the assessment are used to determine eligibility include:
UPSITENRL_TOTAL_CORRECT: Total number of correct items at enrollment
UPSITENRL_ADJVER: The date Blackfynn received the version of the algorithm used to adjust REVISED UPSIT total scores before determing percentile. This adjustment is applied because of the percentile lookup table was developed for the Original version of the UPSIT. At Screening, the UPSIT percentile is used to determine eligibility for Prodromal participants; the adjustment is used only before calcualting the percentile for these particiapnts who are using the Revised UPSIT to prevent them from being excluded unduly.
UPSITENRL_PRCNTGE: UPSIT percentile at enrollment
UPSITENRL_PRCTVER: The date Blackfynn received the version of the lookup table that was used to calculate the participant’s UPSIT percentile at enrollment.
UPSITENRL_ELIGBL: A boolean (True/False) indicator of a participant’s eligibility which is based on their enrollment UPSIT score and percentile (as calculated by the EDC). If a participant’s UPSIT percentile is less than or equal to 10, they are considered ineligible for the study.
UPSITENRL_ELIGWAIV: A boolean (True/False) indicating whether ineligibility based on UPSITENRL_PRCNTGE was overridden. UPSITENRL_ELIGBL will be True in this case, even though UPSITENRL_PRCNTGE is outside the eligibile range.