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.
Joint Bone Spine. 2013 Oct;80(5):471-6. doi: 10.1016/j.jbspin.2012.11.009. Epub 2013 Aug 20.
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.
To elaborate a questionnaire to measure knowledge and skills regarding safety issues, for patients treated by biologics.
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.
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).
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.
生物制剂已知存在特定风险（例如感染）。患者应具备自我护理安全技能，以便在出现风险（例如发烧）时采取适当的行为。迄今为止，尚无评估这些技能的充分工具。
制定一种问卷来衡量接受生物制剂治疗的患者的安全问题知识和技能。
三步骤流程。（1）由 10 名风湿病专家、1 名药剂师和 2 名医疗保健专业人员组成的指导小组详细制定了安全技能清单。通过涉及指导小组、14 名接受生物制剂治疗的患者和 14 名其他医疗保健专业人员的 3 轮 Delphi 流程，技能清单得以简化。（2）设计了相应的一系列问题和多项选择题的临床情况。（3）初步验证基于医生对技能的意见，并评估了可靠性。
清单包括 24 项技能，例如如何应对发烧、计划手术、牙科保健、旅行、小创伤和免疫接种。构建了一个包含 55 个问题的问卷。初步验证（62 名患者）表明，问卷填写时间为 10 分钟（中位数），与医生对技能的意见相关（R=0.47，P<0.0001），但与疾病状况或疾病持续时间无关。中位数评分为 75%（范围 20%-96%）。问卷具有可靠性：组内相关系数为 0.83（95%置信区间：0.63-0.93）。
已经开发出一种简单（多项选择问卷）且有效的工具，用于调查一组核心安全技能。该工具可用于检测有关生物制剂安全性的进一步教育需求，并评估有针对性的教育干预的效果。
