The GRAPHIC study

Contact for the GRAPHIC study is Jay Gracey.

Label printing

The second phase of GRAPHIC (GRAPHIC2) will use labels produced from the LCBRU portal.

Output from the 'graphic_label' module will be:

1 x label for pathology form (S number, lab ID, patient name, DOB, Address)
1 x label with GP details for pathology form (GP surgery name, GP surgery address)
1 x label for serum gel bottle for pathology (S number, lab ID, patient name, DOB)
1 x label for fluoride / glucose bottle for pathology (S number, lab ID, patient name, DOB)

1 x label for serum vaccutainer (lab ID, bottle ID barcode? G2-lab number-s)
2 x edta red (lab ID, bottle ID barcode? G2-labnumber-e1, G2-labnumber-e2)
1 x citrate green (lab ID, bottle ID barcode? G2-labnumber-c)
1 x Paxgene for RNA processing (lab ID, bottle ID barcode? G2-labnumber-p)

1 x urine sterile container (lab ID, bottle ID barcode? G2-labnumber-u)

1 x label for consent form (lab number, ID number, name, DOB)
1 x Physical activity form (lab number, ID number)
1 x Physical examination form (lab number, ID number)
1 x Patient Diary for ABPM (lab number, ID number)
1 x spare for paper version of the questionnaire if necessary (lab number, ID number)

15 labels in total per patient.

Contact with patients for GRAPHIC 2

The plan is to load the GRAPHIC patients into CiviCRM, use Civi to track invitations etc, and then point the label module to the CiviCRM database to access the patient identities.

We have already written to all the families in GRAPHIC 1 (i.e. a letter to each 'mother'). Replies indicate 1,000 willing participants for GRAPHIC 2 - could be isolated individuals, could be families. This was not an 'invitation' but a feasibility study. Now ethics approval has been received, the 1000 need to be invited. At the same time, those mothers who did not reply will get a reminder, asking them to consider participating.

The 1,000 are in an access database (including their GRAPHIC ID numbers). May need some work but could export it into CiviCRM. The data have been exported to a csv file, and we can load them into CiviCRM from there.

Activity schedule is really just a one visit, but ABPM might be done on a separate visit. The activities should only be added to the record once the patient is recruited, so as not to clog up the diary.

FBC samples will be processed in the LCB lab, but this will need a specific data acquisition process which Richard is working on. Other blood results will come from pathology system, using the same DWH approach into i2b2 that we use for BRICCS and GENVASC.

GRAPHIC 2 commits us to send a summary to the patient's GP containing their blood results and ABPM data. The blood results will go directly from the pathology department. A pro forma can be sent by the nurse, using CiviCRM, commenting that the GP should already have received the results, so there is no need to transcribe them.

Implications for the CiviCRM object model:

Custom group: GRAPHIC2 Custom fields: GRAPHIC2/GRAPHIC ID, GRAPHIC2/LAB ID, GRAPHIC2/FAMILY ID, GRAPHIC2/CONSENT FOR FURTHER STUDIES, GRAPHIC2/G1 BLOOD CONSENT, GRAPHIC2/ PRE CONSENT TO GRAPHIC 2

Study: GRAPHIC2

Standard activity timeline: Open Case. That's it. Nothing else.

Recruitment activity timeline: Recruitment Interview. ABPM fitting. ABPM collection. Letter to GP.

The study definition xml file will be attached to this page once completed.

Mapping of graphic participants source file to civicrm object model:

ID Number => GRAPHIC2 / GRAPHIC ID (needs CiviCase entry, maybe import programmatically?) AND / OR 'External Identifier' S Number DO NOT IMPORT Discovered S number => UHL S Number Lab Number => GRAPHIC2 / LAB ID (needs CiviCase entry, maybe import programmatically?) Family Number => GRAPHIC2 / FAMILY ID (needs CiviCase entry, maybe import programmatically?) Date of Letter DO NOT IMPORT Title => Prefix Surname => Last Name Forename => First Name Middle Name => Middle Name Date of Birth => Date of Birth Address 1 => NEEDS EDTING - SHOULD MATCH 'Additional Address 1' Address 2 => NEEDS CLEANING - SHOULD MATCH 'Street address' Address 3 => NEEDS CLEANING - SHOULD MATCH 'Additional Address 2' Address 4 => NEEDS CLEANING - SHOULD MATCH 'City' NEW COLUMN 'COUNTY' => COUNTY Post Code => Postal code Phone Number => Phone (HOME) Alternative contact no DO NOT IMPORT GP Title DO NOT IMPORT GP Surname DO NOT IMPORT GP Forename DO NOT IMPORT GP Address 1 DO NOT IMPORT GP Address 2 DO NOT IMPORT GP Address 3 DO NOT IMPORT GP Address 4 DO NOT IMPORT Height DO NOT IMPORT Weight DO NOT IMPORT BMI DO NOT IMPORT Mean 24hr BP DO NOT IMPORT Mean Day Time BP DO NOT IMPORT Mean Night Time BP DO NOT IMPORT Sodium DO NOT IMPORT Potassium DO NOT IMPORT Urea DO NOT IMPORT Creatinine DO NOT IMPORT Glucose DO NOT IMPORT Urate DO NOT IMPORT Albumin DO NOT IMPORT Adjusted Calcium DO NOT IMPORT Total Cholesterol DO NOT IMPORT HDL Cholesterol DO NOT IMPORT Current Smoker DO NOT IMPORT Advised to stop smoking DO NOT IMPORT Known Diabetic DO NOT IMPORT Known Hypertensive DO NOT IMPORT CHD risk DO NOT IMPORT Stroke risk DO NOT IMPORT Consent(1) for contact re further studies DO NOT IMPORT Consent(1a) for blood to be stored DO NOT IMPORT Consent(2) requested re further studies DO NOT IMPORT Consent2 (nurse/interview?) DO NOT IMPORT Response to consent(2) request DO NOT IMPORT Reminder letter (Sub Study) DO NOT IMPORT Sub Study letter to be sent DO NOT IMPORT Qualitative Study DO NOT IMPORT Flap Gene Study DO NOT IMPORT EPC in CAD Study (Mother) DO NOT IMPORT Position in family DO NOT IMPORT GRAPHIC2 (Mother) letter DO NOT IMPORT GRAPHIC2 response DO NOT IMPORT GRAPHIC2 No of participants DO NOT IMPORT Comments DO NOT IMPORT

Device driver installations

Spirometry (CareFusion) software and drivers will need installing on the two laptops AND on desktop machines in the TMF (room one and room three, and OP53) and in BRU2/CRF (room three).

ABPM software will also need to go on the same machines.

Jay will ask Graeme Deveraux to do this work, while he configures the laptops.