Ruhr Universität Bochum, Germany; Rheumazentrum Ruhrgebiet, Claudiusstr.45, Herne 44649, Germany.
Ruhr Universität Bochum, Germany; Rheumazentrum Ruhrgebiet, Claudiusstr.45, Herne 44649, Germany.
Semin Arthritis Rheum. 2022 Dec;57:152119. doi: 10.1016/j.semarthrit.2022.152119. Epub 2022 Oct 26.
To study the knowledge of patients with chronic inflammatory rheumatic diseases (CIRD) about biosimilars (bsDMARDs), assess patients' satisfaction after being educated about switching of bsDMARDs by rheumatologists compared to nurse specialists, and to explore the impact of multiple switches on patient satisfaction.
Adult patients with CIRD who underwent a non-medical switch from the adalimumab bsDMARDs GP2017 to the adalimumab bsDMARDs MSB 11022 were 1:1 randomized with randomly selected block sizes into two groups in which information about multiple switching of bsDMARDs was provided by either a nurse specialist or a rheumatologist. Validated outcome tools and standardized parameters for disease activity and function were assessed at baseline and 12 weeks after the switch. The primary endpoint was to evaluate whether satisfaction with care differs when education about switching is provided by rheumatologists or nurse specialists. Secondary endpoints were patients' knowledge about bsDMARDs and the efficacy and safety of switching in routine care. Patients' satisfaction with care was assessed by the Leeds Satisfaction Questionnaire. A structured questionnaire was used to assess the patient's knowledge.
A total of 102 patients was randomized, with 40 educated by rheumatologists (39.2%) and 62 by nurse specialists (60.8%). Patients had moderate to low disease activity and limited impairment of physical function without progression on follow-up, implying that switching did not affected disease activity. Almost half of the patients (n = 50, 49%) had undergone one and 52 multiple switches (51%), respectively. Less than one-third of patients were able to correctly answer questions on manufacturing, effectiveness, clinical trial evidence, and cost of bsDMARDs. Patients were generally satisfied with the education - irrespective of whether the information had been provided by nurses or rheumatologists. No relevant differences in the outcomes assessed were observed. Efficacy and safety results were consistent with previously published data.
Patient satisfaction after education about bsDMARDs and multiple switching by nurses and rheumatologists was equally good. Multiple switches had no negative impact on patient satisfaction, and outcomes after switching of bsDMARDs did not significantly worsen. Patients' knowledge about bsDMARDS was limited.
研究慢性炎症性风湿病(CIRD)患者对生物类似药(bsDMARDs)的认知,评估与由护士专家相比,风湿病医生为患者提供关于 bsDMARDs 转换的教育后患者满意度的差异,并探讨多次转换对患者满意度的影响。
纳入接受非医学性阿达木单抗 bsDMARDs GP2017 至阿达木单抗 bsDMARDs MSB 11022 转换的 CIRD 成年患者,按照随机区组大小 1:1 随机分组,两组患者分别由护士专家或风湿病医生提供关于 bsDMARDs 多次转换的信息。在转换前和转换后 12 周,采用经过验证的结局工具和疾病活动度及功能的标准化参数进行评估。主要终点为评估由风湿病医生或护士专家提供关于转换的教育时,患者对护理的满意度是否存在差异。次要终点为常规护理中患者对 bsDMARDs 的认知以及转换的疗效和安全性。采用利兹满意度问卷评估患者对护理的满意度。采用结构化问卷评估患者的知识。
共纳入 102 例患者,其中 40 例由风湿病医生(39.2%)、62 例由护士专家(60.8%)进行教育。患者的疾病活动度处于中度至低度,且在随访期间未出现功能障碍进展,表明转换并未影响疾病活动度。近一半的患者(n=50,49%)经历过一次转换,52 例患者(51%)经历过多次转换。不到三分之一的患者能够正确回答关于制造、有效性、临床试验证据和 bsDMARDs 成本的问题。无论信息由护士还是风湿病医生提供,患者对教育的总体满意度都较高。评估的结局未见明显差异。疗效和安全性结果与之前发表的数据一致。
由护士和风湿病医生提供 bsDMARDs 相关教育和多次转换的信息后,患者的满意度相当。多次转换对患者满意度没有负面影响,bsDMARDs 转换后的结局并未显著恶化。患者对 bsDMARDs 的认知有限。