intecomm-edc 0.1.81

INTECOMM Trial EDC (http://www.isrctn.com/ISRCTN76157257)

intecomm-edc

Controlling chronic diseases in Africa: Development and evaluation of an integrated community-based management model for HIV, Diabetes and Hypertension in Tanzania and Uganda (INTE-COMM study)

Liverpool School of Tropical Medicine

University College London (UCL)

http://www.isrctn.com/ISRCTN15319595

See also https://github.com/clinicedc/edc

• Django 4.2 / python 3.11

• EDC (see setup.cfg for version)

• We run live and UAT on Ubuntu with nginx/gunicorn/mysql 8.1

Basic install

conda create -n edc python=3.11
conda activate edc
git clone https://github.com/intecomm-trial/intecomm-edc.git ~/apps
cd ~/apps
pip install -U .
python manage.py migrate
# run migrate a second time for post-migrate signals
python manage.py migrate

Randomization

Groups of patients are randomized to community integrated care (intervention) or facility integrated care (control).

A patient group is represented by the PatientGroup model. A PatientGroup model instance contains patients who are represented by PatientLog model instances.

Before a group is “ready” to randomize:

• the group membership must meet the ratio of HIV, HTN, DM or multi-morbidity patients.

• the group must meet the minimum group size.

• all patients must be screened as eligible and consented

If “ready”, the patient group is randomized when the PatientGroup model instance saves succcessfully with field randomize_now set to YES.

Randomization occurs in the signal randomize_patient_group_on_post_save. The signal leaves most of the work to the class RandomizeGroup. RandomizeGroup calls it’s randomize method does the following:

• The group is randomized to intervention or control;

• PatientGroup model instance is allocated a group_identifier;

• Each PatientGroup model instance in the group is updated with the group_identifier;

• Each SubjectConsent model instance in the group is updated with the group_identifier (which triggers another signal associated with the subject consent. This signal puts the subject on schedule);

• Each RegisteredSubject model instance in the group is updated with the group_identifier;