BADBIR Adverse Events

1. BADBIR Adverse Events Collecting data in clinic

2. Contents • Aim of BADBIR • Definition of Adverse Events • Adverse events in BADBIR • Adverse event recording in hospital case notes • Examples of questions to ask patients • Conclusion

3. Aim of BADBIR • To investigate the long-term outcome of psoriasis patients treated with biologic agents, with particular reference to safety • Primary endpoints of interest • malignancy • infection requiring hospitalisation • serious adverse events • death

4. What is an Adverse Event? • Any untoward medical occurrence which affects the patient’s health whilst he/she is on BADBIR • e.g. Any new illness, diagnosis, symptoms, accidents, drug reactions, side effects, clinically significant lab results, hospitalisations, surgery including elective, exacerbations of any illness • Does not necessarily have causal relationship with treatment • Applies equally to Conventional Cohort and Biologic Cohort even if the patient is not currently on any systemic treatment

5. An event is serious if it results in.. • Death • Overnight hospitalisation / prolonging an existing hospitalisation • Significant loss of function or disability • Congenital malformation • Life threatening (immediately) • IV antibiotics / antifungals or antivirals • Medically important event (events of special interest)

6. Adverse Events in BADBIR • Frequently the person entering the data for BADBIR has not reviewed the patient in clinic; the data is collected via a case note review. • This review period may relate to a year or more of the entire patient case notes (not just the dermatology section) • It is essential that all adverse events are accurately recorded (with dates if possible) in the hospital case notes so that these can be entered onto the BADBIR database • It is important to ask the patient whether they suffered any adverse events at each BADBIR follow-up as those not requiring a hospital visit or appointment may not be recorded in the patient notes

7. Tips on what to ask Use a specific timeframe with the last BADBIR follow up date as a guide e.g. within the past 6 months Use clear and concise questions Ask the patient to be as specific as possible with dates, when the event occurred and for how long

8. Tips on what to ask Ask the patient: • If they suffered from any new illness even if they did not see a doctor - give examples including common coughs and colds • If they suffered relapses /exacerbations of any ongoing illnesses • If they attended any new GP or hospital appointments including visits to the Emergency Department? (might have resulted in a new diagnosis) • If they had any overnight stays in hospital • If they were prescribed any new medication or changes in current medication and why - include over the counter medicines

9. Example • Doctor: “How have you been feeling since your last appointment?” • Patient: “Apart from a cold last week, fine.” Limiting the question or keeping it too broad will often result in the patient not providing an accurate account of the adverse events.

10. Doctor: “Since your last appointment had you suffered any new illnesses, coughs, colds? Have you had any new appointments with your GP or hospital? Have you been prescribed any new medication or changed what you were previously on?” • Patient: “Yes, I had 3 bouts of colds and a chest infection, which I saw my GP about. He prescribed me antibiotics.” Asking specific questions and providing examples will help the patient understand the question and help them recall any adverse events that occurred.

11. Adverse Event Information collected on the BADBIR databaseat each patient follow up This level of detail needs to be recorded in the patient notes The amount of data collected often depends on the information available within the medical notes

12. Conclusion • Without accurate and complete adverse event data, safety analysis for the register could be incomplete • Patients needs to be asked specific questions about their health since their last follow-up • All adverse events need to be recorded whether or not they are related to the patient’s skin therapy (biologic or conventional) • All adverse events need to be documented accurately in the case notes