Evidence map›Paper›PMID 31335316›Full record

Trial reportBMJ (Clinical research ed.)2019

Long term tapering versus standard prednisolone treatment for first episode of childhood nephrotic syndrome: phase III randomised controlled trial and economic evaluation.

Nicholas J A Webb, Rebecca L Woolley, Tosin Lambe, Emma Frew, Elizabeth A Brettell, Emma N Barsoum, Richard S Trompeter, Carole Cummins, Jonathan J Deeks, Keith Wheatley and 2 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

34 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2024
    Pooled it
  4. Guideline
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  6. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2020
    Pooled it
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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

12 authors.

Nicholas J A WebbDepartment of Paediatric Nephrology, Royal Manchester Children's Hospital, Manchester, UK nicholas.webb@mft.nhs.uk.ORCID 0000-0001-8572-5446
Rebecca L WoolleyBirmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Tosin LambeHealth Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Emma FrewHealth Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Elizabeth A BrettellBirmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Emma N BarsoumBirmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Richard S TrompeterCentre for Nephrology, University College London, London, UK.
Carole CumminsInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Jonathan J DeeksBirmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Keith WheatleyCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Natalie J IvesBirmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
PREDNOS Collaborative Group

Funding

Medical Research Council G0800200Medical Research Council G0800571Medical Research Council MR/L002418/1Medical Research Council MR/P024297/1Medical Research Council MR/R003017/1Medical Research Council MR/R013942/1
6 · The paper itself

Abstract

objectiveTo determine whether extending initial prednisolone treatment from eight to 16 weeks in children with idiopathic steroid sensitive nephrotic syndrome improves the pattern of disease relapse.

designDouble blind, parallel group, phase III randomised placebo controlled trial, including a cost effectiveness analysis.

setting125 UK National Health Service district general hospitals and tertiary paediatric nephrology centres.

participants237 children aged 1-14 years with a first episode of steroid sensitive nephrotic syndrome.

interventionsChildren were randomised to receive an extended 16 week course of prednisolone (total dose 3150 mg/m

main outcome measuresThe primary outcome measure was time to first relapse over a minimum follow-up of 24 months. Secondary outcome measures were relapse rate, incidence of frequently relapsing nephrotic syndrome and steroid dependent nephrotic syndrome, use of alternative immunosuppressive treatment, rates of adverse events, behavioural change using the Achenbach child behaviour checklist, quality adjusted life years, and cost effectiveness from a healthcare perspective. Analysis was by intention to treat.

resultsNo significant difference was found in time to first relapse (hazard ratio 0.87, 95% confidence interval 0.65 to 1.17, log rank P=0.28) or in the incidence of frequently relapsing nephrotic syndrome (extended course 60/114 (53%)

conclusionsClinical outcomes did not improve when the initial course of prednisolone treatment was extended from eight to 16 weeks in UK children with steroid sensitive nephrotic syndrome. However, evidence was found of a short term health economic benefit through reduced resource use and increased quality of life.

trial registrationISRCTN16645249; EudraCT 2010-022489-29.

Indexed as

Long-Term CareNephrotic SyndromePrednisoloneQuality of LifeSecondary PreventionAdolescentChildChild, PreschoolCost-Benefit AnalysisDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug MonitoringFemaleGlucocorticoidsHumansGlucocorticoidsImmunosuppressive AgentsPrednisolone

Identifiers

PMID31335316
PMCPMC6531851

What OpenQuestion holds

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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.