Evidence map›Paper›PMID 21334623›Full record

Trial reportInternational journal of nursing studies2011

A randomised, controlled study of outcome and cost effectiveness for RA patients attending nurse-led rheumatology clinics: study protocol of an ongoing nationwide multi-centre study.

Mwidimi Ndosi, Martyn Lewis, Claire Hale, Helen Quinn, Sarah Ryan, Paul Emery, Howard Bird, Jackie Hill

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of nursing studies, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 21% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
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

8 authors at 4 institutions in 1 country.

Mwidimi NdosiAcademic & Clinical Unit for Musculoskeletal Nursing, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK. M.E.Ndosi@Leeds.ac.uk
Martyn Lewis
Claire Hale
Helen Quinn
Sarah Ryan
Paul Emery
Howard Bird
Jackie Hill
NIHR Leeds Musculoskeletal Biomedical Research Unit · GBUniversity of Leeds · GBHaywood Community Hospital · GBKeele University · GB

Funding

Versus Arthritis 18475
6 · The paper itself

Abstract

backgroundThe rise in the number of patients with arthritis coupled with understaffing of medical services has seen the deployment of Clinical Nurse Specialists in running nurse-led clinics alongside the rheumatologist clinics. There are no systematic reviews of nurse-led care effectiveness in rheumatoid arthritis. Few published RCTs exist and they have shown positive results for nurse-led care but they have several limitations and there has been no economic assessment of rheumatology nurse-led care in the UK.

objectiveThis paper outlines the study protocol and methodology currently being used to evaluate the outcomes and cost effectiveness for patients attending rheumatology nurse-led clinics. DESIGN AND

methodsA multi-centred, pragmatic randomised controlled trial with a non-inferiority design; the null hypothesis being that of 'inferiority' of nurse-led clinics compared to physician-led clinics. The primary outcome is rheumatoid arthritis disease activity (measured by DAS28 score) and secondary outcomes are quality of life, self-efficacy, disability, psychological well-being, satisfaction, pain, fatigue and stiffness. Cost effectiveness will be measured using the EQ-5D, DAS28 and cost profile for each centre. POWER CALCULATIONS: In this trial, a DAS28 change of 0.6 is considered to be the threshold for clinical distinction of 'inferiority'. A sample size of 180 participants (90 per treatment arm) is needed to reject the null hypothesis of 'inferiority', given 90% power. Primary analysis will focus on 2-sided 95% confidence interval evaluation of between-group differences in DAS28 change scores averaged over 4 equidistant follow up time points (13, 26, 39 and 52 weeks). Cost effectiveness will be evaluated assessing the joint parameterisation of costs and effects.

resultsThe study started in July 2007 and the results are expected after July 2011.

trial registrationThe International Standard Randomised Controlled Trial Number ISRCTN29803766.

Indexed as

Cost-Benefit AnalysisTreatment OutcomeAmbulatory Care FacilitiesArthritis, RheumatoidHumansUnited Kingdom

Identifiers

PMID21334623
PMCPMC3629570
OpenAlexW2008805522

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.