Conducting BADBIR Remotely

Contents

This page aims to provide guidance and advice for recruiting patients to BADBIR using postal consent and conducting follow-ups remotely. It is based on the most common questions received from centres on best practice. The following areas are covered, but please contact the BADBIR office if you have any queries:

Postage

Unfortunately we can’t provide additional funding for postage or pre-paid envelopes. If you require funding for postage costs, we suggest contacting your R&D department to ask if you can be allocated money from BADBIR payments for this purpose.

Completing Follow-up Remotely

When you are gathering information for a follow-up remotely, your priorities should be:

  • Drug changes
  • Adverse events

PASI

One of the changes included in Amendment 12 is the ability for us to collect self-assessed PASI from patients. The data entry system to collect SAPASI directly from participants is currently in development and more information will follow soon. If you are already collecting SAPASI routinely at your centre, we can accept them.

If you can’t get a PASI from clinic, at present we’re still paying for follow-ups which are conducted remotely. Make sure that you indicate that the follow-up was conducted remotely when you enter it onto the database.


Patient questionnaires

We are working on an app and web portal for patients to complete the questionnaires at home. We will provide more information when possible.

To collect the patient completed questionnaires in the interim, centres have used the following methods. Please note these have been done by local arrangement at centres and are not mandated in the BADBIR protocol:

  • Post the questionnaires to the patient for them to complete and return to you through post
  • Post the questionnaires to the patient for them to complete before taking a photo/scan and emailing it back to the dermatology department
  • Email the questionnaires to the patient for them to print out and complete, before taking a photo/scan to email back to the dermatology department

The following methods are not recommended:

  • Completing the questionnaires with the patient over the phone
  • The patient typing out their answers to the questionnaires in an email to you

If you can’t get the patient completed questionnaires, please mark as ‘Not completed’ when you enter the follow-up onto the database.

We have heard from some BADBIR centres who have telephoned participants for additional information outside of their normal appointment. For example, when the person conducting the original appointment didn’t get everything required for BADBIR (e.g. additional details on adverse events). If choosing to do this it is entirely your decision. As long as you have local approval to make this additional contact, then we don’t have any objections.

Adverse Events

As the patient is not being seen in person it is important to ask them whether they have had any adverse events since their last BADBIR follow up.

This includes:

  • Coughs, colds, chest infections
  • Any new diagnoses or exacerbations of comorbidities
  • Any new injuries, fractures or visits to A&E
  • Any overnight hospitalisations, IV antivirals, pregnancies or cancers (including skin cancers)
  • Any new COVID-19 diagnoses or suspected cases (please specify whether the patient tested positive or not)

It is important to obtain as much detail as possible about adverse events, including the dates of events (estimated where necessary).