Fayet Francoise, Beauvais Catherine, Pereira Bruno, Béranger Martine, Rodere Malory, Pallot-Prades Béatrice, Peyrard Patricia, Pouplin Sophie, Grandjean Marine, Chu Miow Lin Delphine, Ardizzone Marc, Cherillat Marie Sophie, Tournadre Anne, Fan Angélique, Soubrier Martin
Rheumatology Department, CHU Clermont-Ferrand, 58 Rue Montalembert, Clermont-Ferrand, France.
Rheumatology Department, APHP, Saint Antoine Hospital, Sorbonne University, Paris, France.
Clin Rheumatol. 2025 Jan;44(1):487-494. doi: 10.1007/s10067-024-07218-6. Epub 2024 Nov 5.
To 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.
This 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.
A 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.
Educating 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.
Clinical 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.
评估由护士主导的、结合面对面教育和小组教育课程的干预措施，对接受生物制剂治疗的自身免疫性风湿病患者获取安全技能的有效性。
这项多中心随机对照试验将两次个体患者教育课程与基线时的一次个体课程加3个月后的一次小组课程进行了比较。主要结局是一份经过验证的问卷（BioSecure），在6个月和12个月时进行评分，评估应对发热、感染、疫苗接种和日常情况的能力及解决问题的能力。次要结局包括对疾病的恐惧、焦虑、抑郁和关节炎无助感。
来自法国7个风湿病科的120例类风湿关节炎和脊柱关节炎患者被纳入研究（每组60例）；99例患者在6个月时完成研究，83例在12个月时完成研究。两组在6个月时BioSecure评分均有所改善（面对面教育组较基线增加14.9±16.3，联合教育组增加16.0±17.9），并维持至12个月，但两组在6个月和12个月时无显著差异（分别为p = 0.35和p = 0.13）。对疾病的恐惧、关节炎无助感和焦虑在6个月和12个月时均有所改善，两组间无差异。
采用由护士主导的个体课程或个体与小组课程相结合的方式对患者进行教育，可提高他们使用生物制剂的安全技能，联合形式并未显示出优势。鉴于对患者进行教育所需的时间和资源，这些结果可能会带来潜在的成本节约。
临床试验：NCT03838939。要点 • 与常规护理中风湿病学家提供的信息相比，面对面患者教育已被证明可有效提高接受生物制剂治疗患者的安全技能。 • 这项随机对照试验表明，就6个月和12个月时评估的安全技能而言，将一次个体课程和一次小组课程相结合的患者教育形式并不优于两次个体课程。 • 两组的安全技能、对疾病的恐惧、关节炎无助感和焦虑均有所改善。 • 由于实施患者教育最常见的障碍是时间和资源限制，这些结果可能会带来潜在的成本节约。
