Evidence map›Paper›PMID 33863842›Full record

Trial reportRMD open2021

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.

Juliana Rachel Hoeper, Jan Zeidler, Sara Eileen Meyer, Georg Gauler, Patricia Steffens-Korbanka, Martin Welcker, Jörg Wendler, Florian Schuch, Ulrich von Hinüber, Andreas Schwarting and 3 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in RMD open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 30 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

Juliana Rachel HoeperCenter for Health Economics Research Hannover (CHERH), Leibniz Universität Hannover, Hannover, Germany.
Jan ZeidlerCenter for Health Economics Research Hannover (CHERH), Leibniz Universität Hannover, Hannover, Germany.
Sara Eileen MeyerRheumatologie and Immunologie, Medizinische Hochschule Hannover, Hannover, Germany.
Georg GaulerRheumapraxis an der Hase, Osnabrück, Germany.
Patricia Steffens-KorbankaRheumapraxis an der Hase, Osnabrück, Germany.
Martin WelckerMVZ für Rheumatologie, Planegg, Germany.
Jörg WendlerInternistische Praxisgemeinschaft, Rheumatologie, Erlangen, Germany.
Florian SchuchInternistische Praxisgemeinschaft, Rheumatologie, Erlangen, Germany.
Ulrich von HinüberPraxis für Rheumatologie und Osteologie, Hildesheim, Germany.
Andreas SchwartingDivision of Rheumatology and Clinical Immunology, University Hospital Mainz, Mainz, Germany.
Torsten WitteRheumatologie and Immunologie, Medizinische Hochschule Hannover, Hannover, Germany.
Dirk Meyer-OlsonRheumatologie and Immunologie, Medizinische Hochschule Hannover, Hannover, Germany.
Kirsten HoeperRheumatologie and Immunologie, Medizinische Hochschule Hannover, Hannover, Germany hoeper.kirsten@mh-hannover.de.ORCID 0000-0002-4327-9836
Medizinische Hochschule Hannover · DELeibniz University Hannover · DEJohannes Gutenberg University Mainz · DEUniversity of Hildesheim · DEUrologische Klinik München · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 (p<0.001). No significant differences were observed between the NLC and RLC groups (p=0.317). Non-inferiority of NLC was shown for the primary outcome and all secondary outcomes.

conclusionThis 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 NUMBER: DRKS00013055.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAdultHumansNurse's RolePatient SatisfactionTreatment OutcomeAntirheumatic Agentshealth services researchnursingoutcomes researchrheumatoid arthritis

Identifiers

PMID33863842
PMCPMC8055148
OpenAlexW3154282415

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.