Comparison of group versus individual patient education for promoting safety skills of patients with autoimmune rheumatic diseases treated with biologics: a multicentre randomised controlled trial.

objectiveTo 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.

methodsThis 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. Secondary outcomes were fear of disease, anxiety, depression, and arthritis helplessness.

resultsA total of 120 patients with rheumatoid arthritis and spondyloarthritis were included (60 in each arm) from 7 French rheumatology departments; 99 patients completed the study at 6 months and 83 at 12 months. The BioSecure score improved at 6 months in both arms (delta from baseline 14.9 ± 16.3 in face-to-face education and 16.0 ± 17.9 in combined education) and was maintained for 12 months but no significant difference was found between arms at 6 and 12 months (p = 0.35 and p = 0.13, respectively). Fear of disease, arthritis helplessness, and anxiety were improved at 6 and 12 months with no difference between arms.

conclusionEducating patients using individual nurse-led sessions or a combination of individual and group sessions increased their safety skills on biologics, with no superiority shown for the combined format. Given the time and resources required to educate patients, these results could lead to potential cost savings.

trial registrationClinical Trials: NCT03838939. Key Points • Face-to-face patient education has been shown effective in promoting safety skills of patients treated with biologics compared to information provided by the rheumatologist in usual care. • This randomised controlled trial showed that a patient education format combining one individual and one group session was not superior to two individual sessions regarding safety skills assessed at 6 and 12 months • Safety skills, fear of disease, arthritis helplessness, and anxiety were improved in both arms. • As the most common barriers to the implementation of patient education are constraints in time and resources, these results could lead to potential cost savings.