Click the links below to scroll to the question summary for each section:
- Summary of the changes included in Amendment 12 - Introduction to the BADBIR Patient App/Website
- Changes in practice since COVID-19 - how BADBIR can be conducted remotely
- The importance of collecting the correct trade name for patients on biologic therapy
- The new patient newsletter
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Summary of questions
Will the BADBIR patient app/webpage be accessible for new patients as well as those on follow-up?
Yes, it will be accessible to all patients registered onto BADBIR who have access to the internet.
Will there be an option to collect medical information e.g. adverse events/changes in medications via the BADBIR patient app/webpage?
The first phase will focus on the questionnaires and patient assessed version of the PASI only. The second phase which we are hoping to rollout in 2021 will include a section for reporting adverse events and other medically important information – this will require a further study amendment.
When completing questionnaires via the patient app/webpage, will it prompt the patient when they need to complete the questionnaires?
Initially the patient portal will be web based therefore we will rely on sites to notify the patient when they need to complete follow up questionnaires by accessing a web link. Future development in the second phase of the patient portal will allow for notifications or email prompts.
If we do not have a PASI for the patient’s follow-up will we not be paid for that follow-up?
Previously, money was only paid for follow-ups that provided a PASI score. As the majority of clinics are now remote and patient assessed PASI is not implemented, payment is now made for follow-ups without a PASI score if the follow-up has been marked as remote using the new dropdown box.
For a patient assessed PGA, if the patient states their skin is ‘clear’, is this OK to add directly to the database instead of in feedback? If however a patient gives a ‘woolly’ response, what should I do in this instance?
If the patient states that their skin is ‘clear’ then this is suitable to enter as the PGA. If however it is unclear in the notes we would suggest you mark this as missing. It may be worth asking the clinician to prompt the patient on their Psoriasis Global Assessment by providing them with the options of ‘clear’, ‘almost clear’, ‘moderate’ etc.
Conducting BADBIR Remotely
When entering follow up data from remote clinics I have been stating questionnaire information not available on the database, should we have been posting them out to patients instead?
This would be a centre decision on whether you wish to post questionnaires out to patients, you would need to follow local guidelines but BADBIR are happy for questionnaires to be posted out to patients, and would advise using BADBIR funds to pay for postage costs which can usually be accessed via internal trust R&D. More information can be found on the BADBIR website on conducting BADBIR remotely.
When sending questionnaires via post, how many days would you allow before marking the data as missed?
At baseline and follow-up the edit window on the database stays open for 21 days. If you do enter the clinical information and the patient questionnaires are returned after the edit window is closed, you can contact us and we can open the edit window to allow you to enter the patient questionnaires.
Should we be providing stamped envelopes to the patients in order for them to send the questionnaires back?
This would be a Trust decision but this would make it more likely that patients would return the questionnaires.
How would consenting via phone work? Can we take verbal consent and then proceed to ask questions related to the BADBIR study?
BADBIR are happy for you to explain the study to the patients over the phone and to ask permission to send further information in the post. We believe the clinical questionnaire does not include any questions that would not routinely be available in the notes therefore if you are doing a routine appointment you can collect the relevant information or you could follow-up with a further phone call after you have received the patients consent form.
When taking consent via post should the patient sign the consent form first and post back for the clinician to sign? This will mean the date of consent will be different for patient & clinician, is this OK?
The patient should sign the consent form first and post/email back to site. This will indeed mean the date of consent will be different for patient and clinician, we have therefore added a dropdown box onto the database which asks how the consent was taken: ‘Remotely (email/postal)’ should be selected in this scenario, which will mean we will not query a difference in dates.
Some patients change biologic half way through a follow-up period, is an estimation of date OK when adding start dates for biologics?
We encourage you to provide the most accurate date possible. In an absence of definitive information it is suitable to provide best possible estimate. It would be important if the patient suffered a serious adverse event during this time to establish which biologic or biosimilar the patient was taking at the time.
Could a list of biologic drugs be provided that are currently recruited for in BADBIR?
We have a list of drugs that BADBIR currently recruits for on the Eligibility page of the website. We would suggest speaking to your dermatology department as it would be more beneficial to identify which biologics and biosimilars are used within your trust.
Could we send the newsletter out with the patient questionnaires?
Yes, this would be helpful in disseminating the information to the patients. Currently we do not have the means to print the newsletter and send out to sites due to the BADBIR team working from home, but you can print from the website here: BADBIR Patient Newsletter 2020
Please provide feedback or suggestions for future training events to BADBIR@manchester.ac.uk.