Objective: To evaluate the effectiveness of a nurse-led intervention combining face-to-face and group education sessions for the acquisition of safety skills by patients with autoimmune rheumatic diseases treated with biologics.
Methods: This multicentre randomised controlled trial compared two individual patient education sessions against a combination of an individual session at baseline and a group session 3 months later. The primary outcome was a validated questionnaire (BioSecure) scored at 6 and 12 months that assessed competencies and problem-solving abilities to deal with fever, infection, vaccination, and daily situations.