Safety of biologics: Elaboration and validation of a questionnaire assessing patients’ self-care safety skills: The BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section

BackgroundBiologics are known to entail specific risks (e.g. infections). Patients should possess self-care safety skills to develop appropriate behaviors in situations of risks (e.g. fever). To date, there is no adequate tool to assess these skills.ObjectivesTo elaborate a questionnaire to measure knowledge and skills regarding safety issues, for patients treated by biologics.MethodsThree-step process. (1) A steering group of 10 rheumatologists, one pharmacist and two allied health professionals elaborated an exhaustive list of safety skills. Through a 3-round Delphi process involving the steering group, 14 patients on biologics and 14 other allied health professionals, the list of skills was reduced. (2) A corresponding series of questions and of clinical situations with multiple-choice answers were designed. (3) Preliminary validation was performed against the physician's opinion on skills, and reliability was assessed.ResultsThe list includes 24 skills e.g. how to deal with fever, planned surgery, dental care, travel, minor traumas, and immunizations. A 55-question questionnaire was constructed. Preliminary validation (62 patients) showed the questionnaire was filled in 10 minutes (median) and correlated to the physician's opinion of skills (R = 0.47, P < 0.0001) but not to disease status or disease duration. The median score was 75% (range 20%–96%). The questionnaire was reliable: intraclass correlation coefficient, 0.83 (95% CI: 0.63–0.93).ConclusionA simple (multiple-choice questionnaire) and valid tool investigating a core set of safety skills has been developed. This tool could be useful to detect further educational needs regarding biologics safety, and to assess the efficacy of oriented educational interventions.