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: | Patricia Steffens-Korbanka, Georg Gauler, Jörg Wendler, Sara Eileen Meyer, M. Welcker, Kirsten Hoeper, Dirk Meyer-Olson, Jan Zeidler, Andreas Schwarting, F. Schuch, Juliana Rachel Hoeper, Torsten Witte, Ulrich von Hinüber |
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| Rok vydání: | 2021 |
| Předmět: |
musculoskeletal diseases
Adult medicine.medical_specialty Immunology Rheumatoid Arthritis Nurse's Role law.invention outcomes research Arthritis Rheumatoid Pharmacotherapy Patient satisfaction nursing Rheumatology Randomized controlled trial law Internal medicine medicine Humans Immunology and Allergy Rheumatoid factor biology business.industry C-reactive protein medicine.disease health services research Treatment Outcome Patient Satisfaction Antirheumatic Agents Rheumatoid arthritis biology.protein Medicine Anxiety medicine.symptom Outcomes research business |
| Zdroj: | RMD Open RMD Open, Vol 7, Iss 1 (2021) |
| ISSN: | 2056-5933 |
| DOI: | 10.1136/rmdopen-2021-001627 |
| Popis: | ObjectiveTo 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.MethodsA 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.ResultsDemographic 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 (pConclusionThis study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC.Trial registration numberDRKS00013055. |
| Databáze: | OpenAIRE |
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