Effect of nurse-led care on outcomes in patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target: a multicentre randomised controlled trial

Autor: Jan Zeidler, Torsten Witte, Andreas Schwarting, Kirsten Hoeper, Dirk Meyer-Olson, Florian Schuch, Jörg Wendler, Juliana Rachel Hoeper, Sara Eileen Meyer, Georg Gauler, Patricia Steffens-Korbanka, Martin Welcker, Ulrich von Hinüber
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: RMD Open, Vol 7, Iss 1 (2021)
Druh dokumentu: article
ISSN: 2056-5933
DOI: 10.1136/rmdopen-2021-001627
Popis: Objective To determine the non-inferiority of nurse-led care (NLC) in patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations.Methods A multicentre, pragmatic randomised controlled trial was conducted to assess clinical effectiveness, anxiety, depression and patient satisfaction following a non-inferiority design. The participants were 224 adults with ACPA/RF-positive RA who were randomly assigned to either NLC or rheumatologist-led care (RLC). The primary outcome was the Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP) assessed at baseline and after 3, 6, 9 and 12 months. A DAS28-CRP difference of 0.6 was set as the non-inferiority margin. Mean differences between the groups were assessed following per-protocol and intention-to-treat strategies.Results Demographic data and baseline characteristics of patients in the NLC group (n=111) were comparable to those of patients in the RLC group (n=113). The improvement in disease activity (change in DAS28-CRP, primary outcome) over the course of 12 months was significant in both groups (p
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