类风湿关节炎达标治疗试验：Corrona风湿病网络内的一项整群随机试验。
The rheumatoid arthritis treat-to-target trial: a cluster randomized trial within the Corrona rheumatology network.
作者信息
Harrold Leslie R, Reed George W, Harrington J Timothy, Barr Christine J, Saunders Katherine C, Gibofsky Allan, Greenberg Jeffrey D, John Ani, Devenport Jenny, Kremer Joel M
机构信息
Department of Orthopedics, University of Massachusetts Medical School, Worcester, MA 01655, USA.
出版信息
BMC Musculoskelet Disord. 2014 Nov 21;15:389. doi: 10.1186/1471-2474-15-389.
BACKGROUND
The treat-to-target (T2T) approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity, frequent follow-up visits for patients with moderate to high disease activity, and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores. The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices. It is designed to identify patient and provider barriers to implementing T2T management. This initial paper focuses on the novel study design and methods created to provide these insights.
METHODS/DESIGN: This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T2T or usual care (UC) for qualified patients who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity. Specific medication choices are left to the investigator and patient, rather than being specified in the protocol. Enrollment is expected to be completed by the end of 2013, with 30 practices randomized and enrolling a minimum of 530 patients. During the 12-month follow-up, visits are mandated as frequently as monthly in patients with active disease in the T2T group and every 3 months for the UC group. Safety data are collected at each visit. The coprimary endpoints include a comparison of the proportion of patients achieving low disease activity in the T2T and UC groups and assessment of the feasibility of implementing T2T in rheumatology practices, specifically assessment of the rates of treatment acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity in the 2 groups.
DISCUSSION
This cluster-randomized behavioral intervention study will provide valuable insights on the outcomes and feasibility of employing a T2T treatment approach in clinical practice in the United States.
TRIAL REGISTRATION
NCT01407419.
背景
类风湿关节炎患者的治疗达标（T2T）方法包括使用经过验证的指标来衡量疾病活动度，对中度至高度疾病活动的患者进行频繁随访，以及当患者根据标准疾病活动评分显示治疗反应不足时加大治疗力度。所描述的这项研究是一项新启动的整群随机行为干预研究，旨在评估T2T方法在美国风湿病诊疗实践中的可行性和有效性。其目的是确定实施T2T管理的患者和医疗服务提供者方面的障碍。这篇初始论文重点关注为提供这些见解而创建的新颖研究设计和方法。
方法/设计：该试验将来自现有的Corrona私立和学术机构网络中的风湿病诊疗机构进行整群随机分组，而不是对机构内的患者或个体研究者进行随机分组，以便为符合2010年修订的美国风湿病学会类风湿关节炎诊断标准且疾病活动度为中度至高度的合格患者提供T2T或常规治疗（UC）。具体的药物选择由研究者和患者决定，而非在方案中指定。预计到2013年底完成入组，30个诊疗机构被随机分组，至少招募530名患者。在12个月的随访期间，T2T组中疾病活动的患者每月必须就诊一次，UC组每3个月就诊一次。每次就诊时收集安全性数据。共同主要终点包括比较T2T组和UC组中达到低疾病活动度的患者比例，以及评估在风湿病诊疗实践中实施T2T的可行性，具体评估两组中治疗加速率、就诊频率、根据疾病活动度确定的下次就诊时间以及根据疾病活动度确定的加速概率。
讨论
这项整群随机行为干预研究将为在美国临床实践中采用T2T治疗方法的结果和可行性提供有价值的见解。
试验注册
NCT01407419。
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