Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum; Coordination Center for Clinical Trials of Philipps University Marburg; Institute of Clinical Epidemiology and Biometry, Julius Maximilian University Würzburg; BARMER Health Insurance Fund; The Ruhr District Rheumatology Center, Ruhr University Bochum; Johannes Wesling Minden Hospital, Germany, Department of Rheumatology and Physical Medicine; St. Marien Hospital Vreden, Department of Rheumatology; Specialist rheumatology practices in North Rhine-Westphalia and Lower Saxony.
Dtsch Arztebl Int. 2022 Mar 11;119(10):157-164. doi: 10.3238/arztebl.m2022.0109.
In some areas of Germany, there is a shortage of specialist physicians for patients with inflammatory rheumatic diseases. Delegating certain medical care services to qualified, specialized rheumatological assistants (SRAs) might be an effective way to supplement the available capacity for specialized medical care.
Patients under stable treatment for rheumatoid arthritis (RA) or psoriatic arthritis (PsA) were included in this trial, which was designed to demonstrate, in a first step, the non-inferiority of a form of care involving delegation of physicians' tasks to SRAs (team-based care), in comparison to standard care, with respect to changes in disease activity at one year. "Non-inferiority," in this context, means either superiority or else an irrelevant extent of inferiority. In a second step, in case non-inferiority could be shown, the superiority of team-based care with respect to changes in patients' health-related quality of life would be tested as well. Disease activity was measured with the Disease Activity Score 28, and health-related quality of life with the EQ-5D-5L. This was a randomized, multicenter, rater-blinded trial with two treatment arms (team-based care and standard care). The statistical analysis was performed with mixed linear models (DRKS00015526).
From September 2018 to June 2019, 601 patients from 14 rheumatological practices and 3 outpatient rheumatological clinics in the German states of North Rhine-Westphalia and Lower Saxony were randomized to either team-based or standard care. Team-based care was found to be non-inferior to standard care with respect to changes in disease activity (adjusted difference = -0.19; 95% confidence interval [-0.36; -0.02]; p <0.001 for non-inferiority). Superiority with respect to health-related quality of life was not demonstrated (adjusted difference = 0.02 [-0.02; 0.05], p = 0.285).
Team-based care, with greater integration of SRAs, is just as good as standard care in important respects. Trained SRAs can effectively support rheumatologists in the care of stable patients with RA or PsA.
在德国的一些地区，存在炎症性风湿病患者专科医生短缺的问题。将某些医疗护理服务委托给合格的、专业的风湿病助理（SRAs）可能是补充专科医疗服务能力的有效方法。
本试验纳入了正在接受稳定治疗的类风湿关节炎（RA）或银屑病关节炎（PsA）患者，旨在首先证明，与标准护理相比，将医生的任务委托给 SRAs（团队护理）的护理形式在一年时的疾病活动变化方面具有非劣效性。在这种情况下，“非劣效性”意味着具有优越性，或者是具有不相关的劣效性程度。在第二步，如果能够证明非劣效性，那么将测试团队护理在患者健康相关生活质量方面的变化是否具有优越性。疾病活动通过疾病活动评分 28（DAS28）进行测量，健康相关生活质量通过 EQ-5D-5L 进行测量。这是一项随机、多中心、评估者设盲的试验，分为两个治疗组（团队护理和标准护理）。统计分析采用混合线性模型（DRKS00015526）。
2018 年 9 月至 2019 年 6 月，来自德国北莱茵-威斯特法伦州和下萨克森州 14 个风湿病诊所和 3 个门诊风湿病诊所的 601 名患者被随机分配至团队护理或标准护理组。与标准护理相比，团队护理在疾病活动的变化方面具有非劣效性（调整差异=-0.19；95%置信区间[-0.36；-0.02]；p<0.001 表示非劣效性）。在健康相关生活质量方面未显示出优越性（调整差异=0.02[-0.02；0.05]，p=0.285）。
团队护理，即更多地整合 SRAs，可以在重要方面与标准护理一样好。经过培训的 SRAs 可以有效地支持风湿病专家为稳定的 RA 或 PsA 患者提供护理。
