Conducting BADBIR remotely

Guidance on recruitment, consent and follow-up, conducted remotely.

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.

Postal consent

Postal consent was introduced to BADBIR in Amendment 5 on 05/05/2011.

Eligibility criteria remains the same for patients recruited using postal consent. Please refer to the eligibility page for full information, but in summary:

• The patient has to sign the consent form within 6 months of starting their registration drug
• A DLQI is required for all registrations, dated as close to the start date of their registration drug as possible
• A PASI is required for all registrations, dated as close to the start date of their registration drug as possible

When you have identified a potential recruit for BADBIR, you can send them the patient invitation letter and the patient information sheet for them to look at, along with the consent form and baseline questionnaires to complete and return if they decide they would like to join.

When recruiting patients through postal consent, use the same consent materials as used in clinic. Localised versions can be found in your electronic site file.

When you are ready to send the documents to the patient, you can:

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

Email should only be used for sending or receiving consent forms if you have local approval to do so. If you have local approval, we have no objection. If email is used to exchange documentation, this must be in line with your local policies regarding information security.

For patients recruited through postal consent, it’s acceptable for the date of signature for patient and person-taking-consent to differ.

Baseline information

Here is the full list of items we require at baseline for all patients, including those recruited using postal consent:

• Standard clinical information, including:
  • Psoriasis history
  • Current drugs
  • Past psoriasis treatments
  • Comorbidities
  • Fitzpatrick skin type
  • History of lesions
  • Height measurement
  • PASI
• Patient Baseline Questionnaire
• DLQI

You may wish to consider sending the Patient Baseline Questionnaire and DLQI to the patient with the consent form, so that the patient can complete and return them at the same time. Alternatively, you can provide the patient with information on how to register for the Patient Portal, where they can complete their baseline questionnaires once you’ve added their registration to the database.

As the presence of the PASI and DLQI are necessary for registration, we recommend you have these ready as soon as you add the patient to the database. If there is a slight delay in getting the other information, such as a height measurement, this is acceptable but a query will be raised on the database to remind you that we need this information at some stage.

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.

When completing follow-ups remotely, as an alternative to a PASI and the Psoriasis Global Assessment (clinician PGA), we would encourage you to get a Patient Global Assessment (Patient PGA). Ask the patient “How would you currently rate your psoriasis?” and give them the following options:

• Severe
• Moderate
• Mild
• Almost clear
• Clear

Patient questionnaires

If a patient has a remote appointment, the easiest way for them to complete the patient questionnaires is through our Patient Portal. Full information on how the Portal works can be found in the linked webpage.

If, for whatever reason, the Patient Portal isn’t a feasible option for you or your patients, 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 the 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).