POS1450 PATIENTS’ SAFETY SKILLS ASSESSMENT WITH BIOLOGICS AND JAK INHIBITORS: UPDATE OF THE BIOSECURE QUESTIONNAIRE
Authors: C. Beauvais, V. Gaud-Listrat, J. Sellam, F. Fayet, M. Beranger, N. Deparis, M. Antignac, C. Sordet, M. Rodere, L. Gossec
Journal: Annals of the Rheumatic Diseases (2021)

Background: Biologic disease-modifying anti-rheumatic drug (bDMARDs) and JAK inhibitors (JAKi) may lead to an increased risk of infections, which could be prevented by enhancing patients’ safety skills (ref). We developed a self-administered questionnaire (BioSecure1, ref) in 2013 to assess the patients’ safety skills (Table 1). Following the appearance of new bDMARDs and JAKi and new information on safety, this questionnaire needed updating. Table 1. Nine domains of core safety skills and number of corresponding questions in BioSecure questionnaires. Domain of competence BioSecure1 BioSecure2 General knowledge 4 2 Dealing with infectious symptoms and fever 10 11 Dealing with other infectious symptoms 4 4 Dealing with injuries, preventing infectious complications, vaccinations 8 8 Dental hygiene, preventing infectious complications, information to share with the dentist 2 2 Planning surgery, information to share with the surgeon/anesthesiologist 7 7 Planning child conception 2 1 Communication: who to contact? 2 2 Subcutaneous treatments: cold chain/cold storage, subcutaneous injection techniques 3 0 Objectives: To update the BioSecure questionnaire assessing patients’ safety skills Methods: Four steps by a 10 participants multidisciplinary steering committee. Step1: critical analysis of content and formulations of BioSecure1 on the basis of i) the participants’ own experience of the questionnaire use in current practice (5/10 participants) or research (6/10 participants) ii) assessment of BioSecure1 consistency with current guidelines for management of targeted drugs. Step2: development of a first updated version by a core group of 10 persons. Step3: comments by an extended panel of rheumatology teams interested in therapeutic patient education (TPE). Step4: testing of the final version (Biosecure2) by ten patients through cognitive debriefing. Results: In total, 10 rheumatologists, 6 rheumatology nurses, 1 pharmacist and 1 patient from a patient association participated. Inadequate formulations were reported regarding some situations for which recommendations had the most shifted since Biosecure1 development such as planning pregnancy, remission management and prevention measures before surgery. Features of some infectious conditions were clarified; barriers measures against infection and complications such as sigmoiditis and Herpes Zoster infection were added. BioSecure2 continues to assess the 9 domains of core safety skills (Table 1). The questionnaire was shortened to 50 items (mean filling in time is 10 minutes) with a good understanding and scoring was simplified (mean scoring time 3.5 minutes). Conclusion: BioSecure2 represents an updated outcome measure to evaluate the patient’s skills to prevent adverse events with targeted therapies. This questionnaire can be useful in the context of patient-health professional communication, and as a tool to measure TPE on safety issues. References: [1]Gossec et al, Joint Bone Spine. 2013;80:471–476 Disclosure of Interests: None declared