PATIENT_STATUS

Table Description:

Detailed notes for this table are included below.

1.0 Description: PATIENT_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
ENROLL_CAT	GENPD	Genetic Cohort PD
ENROLL_CAT	GENUN	Genetic Cohort Unaffected
ENROLL_CAT	HC	Healthy Control
ENROLL_CAT	PD	PD
ENROLL_CAT	PRODROMA	Prodromal
ENROLL_CAT	REGPD	Registry PD
ENROLL_CAT	REGUN	Registry Unaffected
ENROLL_CAT	SWEDD	SWEDD
IMAGING_CAT	GENPD	Genetic Cohort PD
IMAGING_CAT	GENUN	Genetic Cohort Unaffected
IMAGING_CAT	HC	Healthy Control
IMAGING_CAT	PD	PD
IMAGING_CAT	PRODROMA	Prodromal
IMAGING_CAT	REGPD	Registry PD
IMAGING_CAT	REGUN	Registry Unaffected
IMAGING_CAT	SWEDD	SWEDD
IMAGING_CAT	no image
RECRUITMENT_CAT	GENPD	Genetic Cohort PD
RECRUITMENT_CAT	GENUN	Genetic Cohort Unaffected
RECRUITMENT_CAT	HC	Healthy Control
RECRUITMENT_CAT	PD	PD
RECRUITMENT_CAT	PRODROMA	Prodromal
RECRUITMENT_CAT	REGPD	Registry PD
RECRUITMENT_CAT	REGUN	Registry Unaffected

Missing Columns

ITM_NAME	DSCR_1.0
CNO	Center Number
DESCRP_CAT	Description of Gene Category
ENROLL_CAT	Enrollment Category
ENROLL_DATE	Enrollment Date
ENROLL_STATUS	Enrollment Status
IMAGING_CAT	Imaging Category
PATNO	Patient Number
RECRUITMENT_CAT	Recruitment Category
STATUS_DATE	Date Enrollment Status Occurred

Details

In both PPMI 1.0 and 2.0, this table has not been associated with a specific CRF. This is a metadata table meant to capture information about participant’s enrollment through the duration of the study. The MOD_NAME for this table (PATIENT vs PARTICIPANT) is a legacy from PPMI 1.0.

Cohort and Subgroups at Enrollment

In PPMI 1.0 information on cohort and subgroups at enrollment were captured in 3 variables: APPDRX, P3GRP, and GENECAT:

• APPDRX : Appropriate Diagnosis

  • 1: Parkinson’s disease

  • 2: Healthy Control

  • 3: SWEDD

  • 4: Prodromal

  • 5: Genetic Cohort - PD

  • 6: Genetic Cohort - Unaffected

  • 7: Genetic Registry - PD

  • 8: Genetic Registry - Unaffected

  • 9: AV133

• P3GRP : Prodromal group type

  • 1: Hyposmia

  • 2: RBD

  • 3: LRRK2

• GENECAT : Gene Category

  • 1: LRRK2

  • 2: SNCA

In PPMI 2.0 cohort are subgroups are collected at participant creation, and can be edited until the participant has been enrolled (after completing their Baseline visit) according to the following rules:

• At participant creation:

  • Cohort is selected from Healthy Control, Parkinson’s Disease, Prodromal, SWEDD, Early Imaging (original study participants only), and Early Imaging 2.0.

    • Since Early Imaging 2.0 participants have to have PD, their cohort is changed to Parkinson’s Disease before transfer to LONI. The variable AV133STDY has been added to indicate whether the participant is also in the PPMI 2.0 Early Imaging Sub-Study.

  • Participants in the Healthy Control, SWEDD, Early Imaging (original study participants only), and Early Imaging 2.0 cohorts cannot select any subgroups.

  • Participants in the Parkinson’s Disease cohort do not need to select a subgroup but can choose between: Sporadic PD, LRRK2, GBA, SNCA, Parkin, and Pink1. If Sporadic PD is selected, no other subgroups can be added.

  • Participants in the Prodromal cohort must select at least one subgroup from the list: Hyposmia / Generalized Risk, RBD, LRRK2, GBA, SNCA, Parkin and Pink1.

• Before the Screening visit:

  • All subgroups can edited, following the same rules as at participant creation.

• After the Screening visit is started and before the Baseline visit is completed:

  • When the visit is started Inclusion/Exclusion criteria for the Parkinson’s Disease cohort is determined by subgroup. This is recorded in the INEXPAGE variable. Participants in the Sporadic PD subgroup recieve the INEXPD CRF, Participants in any of the SNCA/Parkin/Pink1 subgroups recieve the INEXSNCA CRF, and participants in either the LRRK2 or GBA subgroups recieve the INEXLRRK2 CRF. If a participant has some of both the SNCA/Parkin/Pink1 and LRRK2/GBA subgroups they will recieve the INEXSNCA` CRF.

    • Participants in the 2.0 Early Imaging Cohort recieve the INEXPD CRF. Participants in the Healthy Control and Prodromal cohorts recieve the INEXHC and INEXPRO CRFs respectively.

    • See INEX for details on Inclusion/Exclusion CRFs.

  • Subgroups for participants in the Parkinson’s Disease cohort can only be edited such that the Inclusion/Exclusion form would not change. That is, if a participant is recieving the INEXSNCA CRF all of the SNCA/Parkin/Pink1 subgroups cannot be removed and the LRRK2/GBA subgroups cannot be added, but if a participant is recieving the INEXLRRK2 CRF then all of the LRRK2/GBA subgroups cannot be removed and any of the SNCA/Parkin/Pink1 subgroups can be added.

  • Any subgroups can be edited for Prodromal participants, as long as at least 1 remains.

• After Enrollment (once the Baseline visit has ended):

  • No subgroups can be edited. This means that even if it was later discovered that a participant qualified for inclusion in another subgroup that this would not be reflected in these variables. These subgroup variables only represent subgroup status at the time of Enrollment, following the above rules.

Enrollment Status

The ENROLL_DATE records the date that the participant was enrolled in PPMI 2.0 and should remain the same throughout the study. The variables ENROLL_STATUS and STATUS_DATE however, capture the participant’s current enrollment status and the date that status was set.

Removed Variables

Participants in PPMI 1.0 were sorted into several different categories including Gene, Imaging, and Recruitment. In PPMI 2.0, we hope to capture all of this information through a combintaion of the COHORT and SUBGROUP variables.

Future State

In addition to future changes planned for COHORT and SUBGROUP described in the document linked above, we would like to be able keep a log of a participant’s enrollment status, rather than just a snapshot of a participant’s current status.