The NIHR BioResource

Tags: LCBRU Study Category

The NIHR BioResource project was created under the Government's ​Strategy for UK Life Sciences published in December 2011.

The NIHR is investing £2.5m pump-priming this year in a new national NIHR BioResource. The Cambridge NIHR Biomedical Research Centre (BRC) is working with other NIHR BRCs in Oxford and London and with the NIHR Biomedical Research Unit in Leicester to develop this. The new capacity will help companies to recruit patients for stratified experimental medicine studies as well as providing the potential to study the molecular basis of disease, identify the most appropriate biomarkers for diagnosis and drug discovery, and to test the mechanism of action and effects of new drugs.

In Leicester, the LCBRU is participating firstly by approaching participants in existing studies (BRICCS Study, GENVASC Study and GRAPHIC2 Study) and inviting them to also register for the NIHR BioResource.

NIHR BioResource will use many of the LCBRU IT platform tools, in particular:

CiviCRM: For monitoring the invitation process and recruitment status of participants.
REDCap: For electronic data capture from the Bioresource questionnaire.
CaTissue: For sample management and inventory.

NIHR BioResource CiviCase object model

For the BioResource in CiviCRM, the following configurations will be needed.

• New Group for contacts: BioResource

CiviCase

• New Case Type: BioResource

• Standard timeline:
  • Enrol / Open Case
  • Invitation letter

• Recruited timeline:
  • Check study consent
  • Check questionnaire * NEW ACTIVITY
  • Input questionnaire data * NEW ACTIVITY

• Other activities:
  • Send replacement questionnaire * NEW ACTIVITY
  • Send replacement consent form * NEW ACTIVITY
  • Reminder letter

• Custom Fields for study enrollment:
  • NIHR BioResource
    • Consent Q1 Y/N
    • Consent Q2 Y/N
    • Consent Q3 Y/N
    • Consent Q4 Y/N
    • Consent Q5 Y/N
    • Consent Q6 Y/N
    • Date of consent
    • BioResource recruitment ID (must be last for barcode scanning)
  • NIHR BioResource Withdrawal:
    • NIHR BioResource Withdrawal status
      • NOT WITHDRAWN (default)
      • WITHDRAW - KEEP SAMPLES AND DATA
      • WITHDRAW - DESTROY SAMPLES AND DATA

Process

Groups of participants in BRICCS Study, GENVASC Study and other studies will be identified as being suitable for the NIHR Bioresource, and a bulk mailing despatched inviting them to participate. This will be recorded in CiviCRM as an 'activity', and the participant will be added to the Bioresource group, and a Study Enrolment creatd with status 'Recruitment pending'. If there is no response, a report can be generated of participants with status 'Recruitment pending' and a reminder can be sent to the result set.

Where a response is received, a Bioresource ID label should be attached to both the questionnaire and the consent form. The Study Enrolment should be updated to status 'Recruited', with the activities and custom data completed as required.

BioResource ID generation

The Bioresource will need each recruited participant to have a Bioresource ID. These do not need to be randomised, but they do need to be unique. IDs will be in the form "BRxxxxxxxx"

Labels will be printed with the ID in barcode and human-readable form. One to be attached to the consent form, and one to the questionnaire.

Labels will be printed in advance, attached to the paper forms on receipt and entered into CiviCRM and REDCap when the recruitment and questionnaire data is submitted.

The label module zipfile is attached to this page.

Bioresource REDCap questionnaire

The current version of the questionnaire paper form is attached to this page. This is represented in REDCap. The questionnaire was initially built in the Online Designer, then downloaded for additional fields to be added in Excel as a data dictionary, and finally re-uploaded. As of 20th March 2013, the questionnaire development was complete and the questionnaire was ready for testing.

Remaining issues are:

Medications, dose, frequency, cancer, neurological disorders and operations, and the fh_cancer questions all need enumerated answers. There are initial option sets in the questionnaire, but during the initial data entry period, any forms with answers in these categories should be retained, so a decision can be made regarding coding the data.

The family history section poses a problem - could we have a single row of data to collect FH, with a drop down for 'relation', and then the option to 'add more'? Or a question 'how many positive FH do you need to enter?' and then a set of data for each tick? How can matrix fields be used to help here?

GO LIVE

The NIHR BioResource questionnaire in REDCap was set to production status on 25 November 2013. There will need to be some ongoing maintenance of the option groups as above, but it is cleared for data entry.

Test Data

Data for testing the import of BioResource participants into CiviCRM are available at V:\NIHR BioResource\Random_data_for_civi_upload_testing.csv

Regression Test Plan / Summary of Functionality

Here is a list of the actions carried out by the import processes of the NIHR Bioresource CiviCRM module. The list can be used as the basis of a test plan.

1. [x] If the patient already exists, the module will update the details of the patient.
2. [x] If the patient does not already exist, the patient is created.
3. [x] S Number is invalid, an error should be produced (On screen and in watchdog) and continue to the next patient.
4. [x] The patient's prefix (title) should be set correctly.
5. [x] Address details for the patient should be created for a new patient.
6. [x] Address details will be amended for an existing patient, but will not be duplicated.
7. [x] The bioresource contact group should be created when the module is enabled.
8. [x] Patients should be added to the bioresource contact group
9. [x] If the patient already exists, it should not create a duplicate membership of the group.
10. Where the Letter Type = 'Invitation Letter'
    1. [x] If the received date is valid, all activities are created on the received date.
    2. [x] If the received date is invalid but the consent date is valid, all activities are created on the consent date.
    3. [x] If the received date and the consent date are invalid, all activities are created on the 1st Jan of the year the import is run.
    4. [x] A new bioresource study enrollment should be created for the patient.
    5. [x] If a bioresource enrollment for the patient already exists, an error should be produced (On screen and in watchdog) and continue to the next patient.
    6. [x] Creates an invitation letter activity against the enrollment.
    7. [x] If Check Questionnaire is checked, creates a check questionnaire activity - 'completed'.
    8. [x] If check questionnaire is checked, creates a check consent activity - 'scheduled'.
    9. [x] If check questionnaire is checked, creates an import study data activity - 'scheduled'.
    10. [x] If Declined checked, creates a check consent activity.
    11. [x] If Declined checked, changes the enrollment status to 'Declined' and creates an activity for change of status, using the consent date.
    12. [x] If Declined is checked, creates a check study questionnaire activity - 'scheduled'
    13. [x] If Declined is checked, creates an import study data activity - 'scheduled'
    14. [x] If Consent checked, creates a check consent activity - 'completed'.
    15. [x] If consent checked, changes the enrollment status to 'Recruited' and creates an activity for change of status.
    16. [x] If the consent is checked and the consent date is valid, sets the consent date custom value.
    17. [x] If the consent is checked but the consent date is invalid, does not set the consent date.
    18. [x] If the consent is checked, creates a check study questionnaire activity - 'scheduled'
    19. [x] If the consent is checked, creates an import study data activity - 'scheduled'
11. Where the Letter Type = 'Reminder Letter'
    1. [x] If the enrollment does not exist, an error should be produced (On screen and in watchdog) and continue to the next patient.
    2. [x] Creates a reminder letter activity against the enrollment.
    3. [x] If consent, declined or questionnaire checked columns are 'Y', not activities or enrollment statuses are changed.

Identification of Patient's Eligible for Invitation to the Bio-Resource

Patients from various studies can be invited to join the bio-resource. The process for this is:

1. Identify patients from a study that are eligible to join other studies.
2. Identify patients eligible to join other studies that have not already been invited into the Bio-Resource.
3. Check the patients are still alive and get their current address.
4. Create the invitations for these patients and record that they have been invited.

Each of the studies have slightly different criteria for eligibility into the bio-resource.

All Studies

• Contact Type: Subject
• Deceased: No

GENVASC Study

• Study Status: Available for Cohort
• Box 7: Yes

GRAPHIC2 Study

• Study Status: Recruited
• Consent for further studies: Yes
• Activity: Thank you Letter (Completed)

BRICCS Study

• Study Status: Recruited
• Consent Q4: Yes

1. Identify patients from a study that are eligible to join other studies

Goal: Each study has a group called something like 'Study Name available for other studies'.

GENVASC Study & BRICCS Study

1. Create a smart group in the advanced search.

GRAPHIC2 Study

1. Run an Enrollment Activity Search for the completed Thank You letter activity and create a group from the results.
2. Create a smart group based on the Thank You letter group combined with the other criteria.

2. Identify patients eligible to join other studies that have not already been invited into the Bio-Resource.

1. Run a Got This Not That search against one or more of the above groups where:
   1. The patient is not deceased.
   2. GOT (in the primary study enrolment) 'enrol into study'.
   3. GOT (in the primary study enrolment) another guaranteed activity, as appropriate.
   4. NOT GOT (in a BioResource enrolment) 'invitation letter sent'.
2. For the resultant contacts run a Update Demographics (Deceased and Address) task.
3. Rerun the search from step 1.
4. For the resultant contacts, run a task to create the PDF invitation letters.
5. For the resultant contacts, run a task to create a Bio-Resource case for each contact.
6. For the resultant contacts, run a task to add the contact to the Bio-Resource group.

NOTE: The 'Got This, Not That' isn't the most efficient way of searching for these contacts. Refactor this later.

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