title: 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.
abstract: BACKGROUND
  Biologics 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.
  
  
  OBJECTIVE
  To elaborate a questionnaire to measure knowledge and skills regarding safety issues, for patients treated by biologics.
  
  
  METHODS
  Three-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.
  
  
  RESULTS
  The 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).
  
  
  CONCLUSIONS
  A 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.
authors: Université Pierre et Marie Curie (UPMC) - Paris 6, GRC-UMPC 08 (EEMOIS), AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, 83, boulevard de l'hôpital, 75013 Paris, France. Electronic address: Laure.gossec@psl.aphp.fr.
authors: Laure
authors: L
authors: Gossec
authors: Bruno
authors: B
authors: Fautrel
authors: Élisabeth
authors: É
authors: Flipon
authors: France
authors: F
authors: Lecoq d'André
authors: Laurent
authors: L
authors: Marguerie
authors: Henri
authors: H
authors: Nataf
authors: Béatrice
authors: B
authors: Pallot Prades
authors: Muriel
authors: M
authors: Piperno
authors: Rose-Marie
authors: RM
authors: Poilverd
authors: Anne-Christine
authors: AC
authors: Rat
authors: Fatiha
authors: F
authors: Sadji
authors: Christelle
authors: C
authors: Sordet
authors: Corinne
authors: C
authors: Thevenot
authors: Catherine
authors: C
authors: Beauvais
mesh_terms: D000328:Adult; D001168:Arthritis / Q000628:therapy*; D001691:Biological Therapy / Q000009:adverse effects; D003430:Cross-Sectional Studies; D003697:Delphi Technique; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D012648:Self Care / Q000592:standards*; D011795:Surveys and Questionnaires
keywords: Biological therapy; Injections; Outcome assessment; Patient education