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    The rheumatoid arthritis treat-to-target trial: a cluster randomized trial within the Corrona rheumatology network

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    Authors
    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.
    UMass Chan Affiliations
    Department of Orthopedics
    Document Type
    Journal Article
    Publication Date
    2014-11-21
    Keywords
    rheumatoid arthritis
    treat-to-target (T2T)
    Health Services Research
    Immune System Diseases
    Musculoskeletal Diseases
    Rheumatology
    
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    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.
    Source
    BMC Musculoskelet Disord. 2014 Nov 21;15:389. doi: 10.1186/1471-2474-15-389. Link to article on publisher's site
    DOI
    10.1186/1471-2474-15-389
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/30372
    PubMed ID
    25416400
    Related Resources
    Link to Article in PubMed
    Rights
    Copyright © Harrold et al.; licensee BioMed Central Ltd. 2014. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
    ae974a485f413a2113503eed53cd6c53
    10.1186/1471-2474-15-389
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