BRICCS Study

Tags: LCBRU Study Category

BRICCS, the Biomedical Informatics Centre for Cardiovascular Science, is the founding project behind the BRICCS platform, now the LCBRU IT Platform. BRICCS is a cohort discovery project to accelerate recruitment into translational medicine studies, recruiting patients with cardiovascular conditions (ACS, Aortic Stenosis, CHD, heart failure, etc) into a population from which cohorts can be isolated for common phenotypes.

BRICCS uses - and provided the initial impetus for development of - most of the tools in the LCBRU IT Platform.

Onyx: For recruitment management and electronic data capture / questionnaire.
CiviCRM: For electronic data capture / questionnaire, from October 2014.
REDCap: For recruitment management, from October 2014.
CaTissue: For specimen collection management and inventory.
i2b2: For cohort discovery and clinical data integration.

Transition to REDCap

As from October 2014, recruitment into BRICCS will be performed using REDCap not Onyx. We will therefore need a revised process in CiviCRM to ensure that the full set of recruited participants is accurate in CiviCRM, which currently relies on an automated feed from the Onyx database to populate CiviCRM records.

CiviCRM

There is a basic case type definition for BRICCS in CiviCRM. This currently provides a standard timeline for only a 'Recruit and Interview' event and a 'Participant loaded into i2b2' event. There is also a 'Withdrawal' activity available.

This will need expanding to enable full study management in CiviCRM. Enrolments will need an activity or status to indicate that recruitment is completed, mirroring the 'available for cohorting' concept in GENVASC.

In the case type definition XML, the 'Recruit and Interview' activity should no longer be created in the 'Completed' state, but 'Scheduled'. Ultimately, the BRICCS module should enable data submitted in CiviCRM to be passed via the REDCap API to create a stub record in REDCap for data entry.

But as an interim, manual data entry in both CiviCRM and REDCap would be acceptable. Process should be: search for patient first in CiviCRM to ensure no duplicate entry, create a record in CiviCRM and enrol the participant in the BRICCS study, entering custom data manually. Then switch to REDCap and enter the questionnaire data (note that for the time being this involves a small amount of double entering of consent data etc).

When we roll out data flows between CiviCRM and REDCap, the process will be that administrators can create enrolments in CiviCRM at the time of invitations being issued, which automatically creates a stub record in REDCap. When the nurse interviews the participant in REDCap, the data flows back into CiviCRM to update the enrolment with custom data and an updated status.

We also need to verify that all Onyx data is accurately captured in CiviCRM. This can be performed as part of the 'Onyx closedown' process.

Remote sites

Multiple sites came on board with BRICCS in September 2014, using REDCap as the data collection tool on an externally-facing server accessed over the NHS N3 secure network. See External BRICCS Sites for details.

SUPERCEDED

See Northampton Recruitment into BRICCS for details of the parallel recruitment project, whereby patients are being recruited into the BRICCS population from non-UHL hospitals, initially Northampton General Hospital.

In addition we're planning to roll out recruitment to Leeds and potentially Derby, Burton and Kettering. For these sites recruitment will only be for Aortic Stenosis in the initial phase. As a result, a reduced recruitment questionnaire is needed to accelerate recruitment. Work on that BRICCS reduced questionnaire is ongoing.

Recruitment reporting

As from November 2014, recruitment is monitored in REDCap for all sites (excluding Northampton, which is still using Onyx). To collect recruitment monitoring data from REDCap, the REDCap logging table can be used.

November 2014 example - Leicester:

• mysql -h briccsdb -u auditor -p redcap -e "SELECT pk,project_id,ts from redcap_log_event where event = 'INSERT' and object_type = 'redcap_data' and project_id = '24' and ts > '20141101000000' and ts < '20141201000000' order by ts;" > briccs_enrolment_leicester_2014_11.txt

November 2014 example - external sites:

Note: Project ID 12 is the DEMO project. Watch that when other externally facing projects are set up, they don't mess with the reporting...

• mysql -h briccsdb -u auditor -p redcap_briccsext -e "SELECT pk,project_id,ts from redcap_log_event where event = 'INSERT' and object_type = 'redcap_data' and project_id <> '12' and ts > '20141101000000' and ts < '20141201000000' order by ts;" > briccs_enrolment_external_sites_2014_11.txt

SUPERCEDED As of February 2013, the BRICCS project was included in the Leicestershire, Northamptonshire and Rutland CLRN Portfolio. Monthly reporting is therefore required for the CLRN, starting with an initial report of recruitment from the start until the end of January:

• mysql -h briccsdb -u auditor -p briccs -e "SELECT barcode, start_date, status FROM participant ptone, interview WHERE NOT EXISTS (SELECT 1 FROM participant pttwo WHERE pttwo.enrollment_id = ptone.enrollment_id LIMIT 1, 1 ) AND barcode is not null AND status <> 'CANCELLED' AND ptone.id = interview.participant_id order by start_date;" > briccs_enrollment_to_date.txt

After that first report, each month the report should be re-populated with a specific month's recruitment FROM BOTH THE LEICESTER AND NORTHAMPTON DATABASES

Examples from Jan 2014:

• mysql -h briccsdb -u auditor -p briccs -e "SELECT barcode, site_no, start_date, status FROM participant ptone, interview WHERE NOT EXISTS (SELECT 1 FROM participant pttwo WHERE pttwo.enrollment_id = ptone.enrollment_id LIMIT 1, 1 ) AND barcode is not null AND status <> 'CANCELLED' AND start_date > '2014-01-01 00:00:00' AND start_date < '2014-02-01 00:00:00' AND ptone.id = interview.participant_id order by start_date;" > briccs_enrollment_leicester_2014_01.txt

• mysql -h briccsdb -u auditor -p briccs_northampton -e "SELECT barcode, site_no, start_date, status FROM participant ptone, interview WHERE NOT EXISTS (SELECT 1 FROM participant pttwo WHERE pttwo.enrollment_id = ptone.enrollment_id LIMIT 1, 1 ) AND barcode is not null AND status <> 'CANCELLED' AND start_date > '2014-01-01 00:00:00' AND start_date < '2014-02-01 00:00:00' AND ptone.id = interview.participant_id order by start_date;" > briccs_enrollment_northampton_2014_01.txt

Reports are generated and sent to Angel Christian at angel.christian@…

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