The A3BC has commenced small-scale participant recruitment for pilot testing of study procedures at a small number of sites. Testing should be complete and full operations starting in late 2019. Please continue to check our website for updates on the official starting dates for recruitment at each clinical site.
Once your rheumatologist has determined that you meet the eligibility criteria you will be asked to provide your informed consent to enter the A3BC. This can occur either in-person or remotely depending on your and your rheumatologist’s preferences:
The rheumatologist and research team complete the A3BC Permission to Contact (PTC) form and Case Report Form (CRF) with you (or the parent/guardian) and discusses the A3BC Participant Information Sheet and Consent Form (PICF) with you (or the parent/guardian). You (or the parent/guardian) complete the consent form on paper or electronically to enter the A3BC and your/your child’s first blood collection is scheduled.
The rheumatologist and research team complete the A3BC Permission to Contact (PTC) form and Case Report Form (CRF) with you (or the parent/guardian) and then you go home. You (or the parent/guardian) receive an email link containing the A3BC Participant Information Sheet and Consent Form (PICF) and you complete it on your computer or mobile device to enter the A3BC. You (or the parent/guardian) is soon thereafter advised when/where your/your child’s first blood will be taken (usually part of routine care).
Once you consent to participate in the A3BC, you will be sent your first questionnaire and scheduled for your first blood collection.
Two defined recruitment/consent processes will occur for paediatric versus adult A3BC cases. As illustrated below, while adult cases will be recruited and consented directly into longitudinal sample and data collection with the A3BC, paediatric cases will be sequentially offered consent to 2 levels of participation in order to avoid over-burdening patients and their families. The 2 paediatric case participation levels are as follows:
1. Enrol to ANZ CLARITY
2. Enrol to A3BC Longitudinal
JIA participants will first be explained the purpose of both studies, and what their involvement would be, in similar detail. Following these explanations and allowance for questioning, the participant will first be asked if they consent to enter the once-off collection of the ANZ CLARITY study. If the participant agrees to enter the ANZ CLARITY, they will then immediately be asked if they would agree to extend their participation to longitudinal collection within the A3BC (and ARAD). If the participant agrees to enter the A3BC, they will follow the associated biospecimen and data protocol (described here, developed in consultation between the A3BC and ANZ CLARITY), and the baseline biospecimens and data will become a shared resource between the two groups. Of note, while the baseline biospecimens and data will become a shared resource, longitudinal biospecimens and data collection beyond baseline will be the responsibility and custodianship of the A3BC Consortium.
Once you have completed the A3BC PICF, you will be asked to provide the following:
- A small blood sample for processing and storage in the A3BC Biobank. Where possible, we will do this at the same time you are having one of your regular blood tests. That way, no extra needles or appointments are required. The study coordinator will coordinate with the blood collecting service at the time of your routine blood test. About 50-60mls of blood will be collected from you at 0, 6, 12 and 24 months from commencement of your treatment or enrolment in the biobank. Collection times may occasionally be adapted where significant unforeseen changes in disease (flares) or treatment status occur.
- Online questionnaires in which you answer questions about your symptoms, treatments, medical history, quality of life, lifestyle, occupational history, family history, environmental exposures and diet.
With your blood sample, we can learn how your immune system is working. We can look to see if there have been any changes in your DNA that might be relevant to developing immune system diseases. DNA is an essential molecule for life. Think of it like a recipe holding the instructions telling our bodies how to grow and work.
If collecting a blood sample at the same time as a routine blood test is not possible, with your consent, you can still provide a blood sample for the biobank. When it is convenient for you, a nurse trained in collecting blood will collect your blood sample. Before your blood test, the blood collection service, or our study nurse will offer to put a patch of numbing cream to the area of skin on your arm where the blood sample will be collected.
- If you are unable to give blood, you will be asked to collect a small sample of your saliva in a tube and post it back to the biobank. Blood is preferred wherever possible as much more information can be gained from blood.
- Synovial tissue and/or synovial fluid not needed as part of your care may be collected. This tissue or fluid collection will take place as part of joint tissue removal (called synovial biopsy – conducted using an arthroscope) or a joint injection (called synovial fluid aspiration), which is already being undertaken as part of your standard care. If you do not have a joint tissue removed or a joint injection, we will not collect a synovial tissue or fluid sample from you unless you are involved in an ethics-approved research project.
- Permission to access your Newborn Screening Card (NBS or also known as a Guthrie card) stored in State genetic health services. All newborn Australian babies have a heel prick blood test taken in the first few days of life by a midwife. Some blood is tested for serious and treatable diseases. The remaining blood is stored as an NBS card at State newborn screening services. Our ability to access to your NBS depends on how long each State keeps them after birth: VIC, SA, TA NT – indefinitely; QLD – 25 years, NSW – 18 years, and WA – 2 years. The NBS sample is important as it is a pre-disease blood sample, which may contain information about you before you were diagnosed with arthritis, which we can compare to post-diagnosis blood sample and data collected by this study. We would identify your NBS card using your name and date of birth (DOB), mother’s name (at time of your child’s birth) and DOB, and hospital where you were born.
- Depending on your treatment and/or condition, we may seek approval from Pathology Services (State-run and private) to access samples previously collected from you, which are no longer required for clinical/diagnostic purposes.
- Collected imagery. The A3BC may collect histology and radiology images for investigations such as X-ray, MRI, and ultrasound, from your physician or pathologist. Histology images can assist researchers in selecting the right sample from the biobank, and images may be used by researchers to look at how your anatomy and tissue are linked to other disease factors.
In completing the A3BC consent form, you are providing permission to access your health data through data linkage to:
- Commonwealth health data (MBS, PBS, Cancer registry)
- Electronic medical records (EMR) for clinical/medical data
- Rheumatologist clinics for clinical outcomes and histories
- Medical imaging centres for X-ray, MRI, CT or ultrasound data
- National registries, such as Cancer, Death, Joint Replacement
- Longitudinal/Lifecourse research studies (CLARITY, NWAHS, etc)
Access to the linked health datasets mentioned above will enable the A3BC to gain a comprehensive picture of participant health, so researchers can explore the links and causes of the wide-ranging health impacts that occur in people with arthritis. Without access to these broad datasets, it is more likely that important links will be missed. Information to be collected includes prescription, medical services/treatment, and clinical outcomes data. These are key for accurately linking clinical care choices to health outcomes, to inform policy and practice.
There are no additional costs associated with participating in the A3BC. And you will not be paid for participation. If you decide to participate in the A3BC project, we will notify your local doctor. Participation is completely voluntary and will have no impact on the quality of your care or relationship with your rheumatologist, however the more you are able to contribute to the project, the more valuable the A3BC will become for researchers and doctors. We encourage you to discuss your participation with your rheumatologist and/or research nurse. Alternatively, if you would like to learn more from A3BC staff, please email us at firstname.lastname@example.org