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Description:

intecommrando 0.1.25

intecomm-rando
Randomization for INTECOMM trial
A dependency of the INTECOMM trial EDC.
The INTECOMM trial is a cluster randomized trial where the unit of randomization is the patient group.
At screening, data for individual potential participants are stored in the intecomm_screening.PatientLog model.
Eligible individual potential participants (model PatientLog) are added to a patient group (model intecomm_group.PatientGroup).
The data flow is PatientLog -> SubjectScreening -> if eligible -> SubjectConsent
Ideally, for a patient group to be considered for randomization, the group must contain
between 9-14 screened and consented members where a count of chronic conditions of those in the group meets an
approximate ratio of 2 : 1; that is, 2(DM/HTN) : 1(HIV). The site coordinators may override these values.
Once a PatientGroup is ready to randomize, the site staff open the PatientGroup form and click “randomize”.
In the background, the Randomizer class calls its method randomize_group. randomize_group picks the next
available record from the randomization_list (‘’intecomm_rando.RandomizationList``) and inserts a unique group_identifier value.
A records is available if group_identifier has not been set. Ordering is ascending by sid.
The PatientGroup is given its newly allocated group_identifier. The subjects in this group may now be
followed longitudinally starting with visit 1000.
The group_identifier, for subjects in a PatientGroup, is updated on the PatientLog record as well.

The RegisteredGroup model holds the sid to group_identifier relationship
The RandomizationList model holds the sid to assignment to group_identifier relationship
PatientLog links group_identifier and subject_identifier

See also tables:
• Intecomm_rando_registeredgroup
• Intecomm_rando_randomizationlist
• intecomm_screening_patientlog
• intecomm_group_patientlog