Abstract:
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.
journal_name
BMC Musculoskelet Disordjournal_title
BMC musculoskeletal disordersauthors
Harrold LR,Reed GW,Harrington JT,Barr CJ,Saunders KC,Gibofsky A,Greenberg JD,John A,Devenport J,Kremer JMdoi
10.1186/1471-2474-15-389subject
Has Abstractpub_date
2014-11-21 00:00:00pages
389issn
1471-2474pii
1471-2474-15-389journal_volume
15pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:Of all athletic knee injuries an anterior cruciate ligament (ACL) rupture results in the longest time loss from sport. Regardless of the therapy chosen, conservative or reconstructive, athletes are often forced to reduce their level of physical activity and their involvement in sport. Moreover, a recent revi...
journal_title:BMC musculoskeletal disorders
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pub_type: 杂志文章,多中心研究,随机对照试验
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