From the PERUKI webinar held on 7th December 2022
Which are the inclusion criteria? Are you collecting only cases that meet the A/B/C criteria for anaphylaxis? Or are you also collecting milder allergic reactions that might involve only GI tract and skin, for example? We are collecting severe allergen-induced reactions with an emphasis on those with features of anaphylaxis. Where the clinician is confident that no allergen exposure is likely to be involved e.g., Idiopathic urticaria, then absolutely no need to report. The priority for reporting is:
Do you want to collect information about patients who have anaphylaxis during hospital food challenges? We are only collecting information on “unintended” allergic reactions, either to food or non-food triggers occurring outside hospital. We are NOT collecting information on deliberate challenges that take place in hospital.
If a patient has multiple episodes, should we enrol them multiple times (i.e. is the registry for per patient, or per episode, data collection)? Per episode. If a patient has multiple episodes, we are very happy to have a case report for each episode.
What identifiable data is collected? Only date of reaction, age in years, and sex will be collected in the case report form.
Can the form be filled in retrospectively with patients in clinic or research visits if the episode is within the last 12 months, but the form wasn’t completed in ED? Yes, it is possible but please remember that you need to seek verbal consent and the email of the patient to be able to have access to the Case Report form and this must be done by the members of the active clinical team that liaise with potential patients in the first instance. If someone who is a member of the research team (or indeed, a different clinical team not involved in that patient’s care) contacts the person who had the allergic reaction (or their parent/carer etc), then they do not have legal consent to access that person’s details and would therefore be breaking data protection legislation. This can only be for episodes that occurred within the previous 12 months.
How long will it take me to complete the case report form? This depends on the complexity of the case. The case report has branching logic, but the average completion time for the form is around 5-8 mins for the A&E case report and 10-15 mins for the clinic Case report. We’ve tried to make it as quick as possible.
If consent is not received, do we still complete the CRF? Yes, please fill out the CRF. Once the email to the patients is sent, they have 28 days to click on the link, read the PIS and give consent. After this period the link will expire, and the Registry can retain the data inserted in the CRF indefinitely as verbal consent was sought initially with the email address.
Can the form be completed by research nurse from notes? Yes. Please set up a centre-based account if you want to share within your team (nurses as well).
Could we complete the paper proforma whilst seeing the patient and then dispose/shred if the family do not consent to participation? Yes. However the paper form will not have the same branching logic as the online version. You are not required to keep the paper copy in your records.
Can we use the output to paste this into our electronic records? Yes. If you feel the output form provided at the end of data entry is sufficient for medical records at your site, you are welcome to do so.
We have been let down before with accruals for data collection studies. Is this a promise or a definite?The Registry is included on the NIHR-CRN portfolio. For each completed CRF, the local centre will receive accruals. The Registry team will log cases centrally and upload them manually on CPMS.
Will you get accrual at the initial registration or only when patient consents? When the case report is completed and submitted, no need of patient consents.
Will we need to get official approval (eg confirmation of capability and capacity) from our trust before we can enrol patients? The UK Anaphylaxis Registry has been approved by a Research Ethics Committee as a Research Database. Under HRA processes for Research Databases, UK Healthcare Professionals can register via the online system, and HRA approval is not required https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/research-tissue-banks-and-research-databases/. Local R&D review is not necessary (similarly, there is no need for site-specific contracts with us, or “green light”). We interact directly with the Healthcare Professionals that want to report allergic reactions and to do so they need to submit their request to become a Contributor using https://bit.ly/uk-anaphylaxis.
Will we have the HRA approval paperwork to at least show R&D? All study documents are available at UK Anaphylaxis Registry: REC documents. if you cannot access this we can provide them by email on request from [email protected].
I’m surprised that we don’t need to have local R&D approvals for this work, given we are asking families to read a PIS and to provide consent. There is no hardcopy (paper) PIS for the patient/family, but this is sent to them electronically using the email you enter after receiving verbal consent to do so. They then have the opportunity to consent to, or decline, participation in the study via this email link.
Regarding GDPR, specifically on gaining email address and consent to contact, does that need to be documented? Is that covered through the HRA approval? There is no need to document the verbal consent and the email. When healthcare professionals have identified a potential case, they need to seek verbal consent from the parent and their email address. The email is necessary for the user of the Registry platform to have access to the CRF and therefore to prove that the family has been informed about the study. Once the user logs in the Registry, the platform will generate an automatic email to be sent to the patient (using the email address gained during verbal consent). As soon as sent out the email will disappear from the platform, and we will not have access to this information. This process is covered through the REC approval.
Is GCP required and training requirements? It is not necessary for a clinician to hold current GCP training in order to complete the Case Report Form and enrol a patient. However as verbal consent needs to be obtained from patients/families, individuals should be given appropriate training to do so – this may include GCP or local study-specific training.
Scotland may have different approval requirements. Do you know if these have been sought? There are not different approval requirements for Scotland as this is a Research database and the approval covers the healthcare professional across the UK.