Evidence map›Paper›PMID 25885677›Full record

Trial reportTrials2015

Can oral corticosteroids reduce the severity or duration of an acute cough, and the associated National Health Service and societal costs, in adults presenting to primary care? Study protocol for a randomised controlled trial.

Harriet E Downing, Fran Carroll, Sara T Brookes, Sandra Hollinghurst, David Timmins, Elizabeth Orton, Kay Wang, Denise Kendrick, Paul Little, Mike V Moore and 5 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 31% 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

2 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
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

15 authors at 4 institutions in 1 country.

Harriet E DowningCentre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. harriet.downing@bristol.ac.uk.
Fran CarrollCentre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. fran.carroll@bristol.ac.uk.
Sara T BrookesCentre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. s.t.brookes@bristol.ac.uk.
Sandra HollinghurstCentre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. s.p.hollinghurst@bristol.ac.uk.
David TimminsNuffield Department of Primary Care Health Sciences, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. david.timmins@phc.ox.ac.uk.
Elizabeth OrtonDivision of Primary Care, University of Nottingham, Floor 13, Tower Building, University Park, Nottingham, NG7 2RD, UK. elizabeth.orton@nottingham.ac.uk.
Kay WangNuffield Department of Primary Care Health Sciences, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. kay.wang@phc.ox.ac.uk.
Denise KendrickDivision of Primary Care, University of Nottingham, Floor 13, Tower Building, University Park, Nottingham, NG7 2RD, UK. denise.kendrick@nottingham.ac.uk.
Paul LittleUniversity of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO15 5ST, UK. p.little@soton.ac.uk.
Mike V MooreUniversity of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO15 5ST, UK. mvm198@soton.ac.uk.
Anthony HarndenNuffield Department of Primary Care Health Sciences, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. anthony.harnden@phc.ox.ac.uk.
Matthew ThompsonNuffield Department of Primary Care Health Sciences, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. matthew.thompson@phc.ox.ac.uk.
Margaret T MayCentre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. m.t.may@bristol.ac.uk.
Alastair D HayCentre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. alastair.hay@bristol.ac.uk.
OSAC trial team
University of Bristol · GBUniversity of Nottingham · GBJohn Radcliffe Hospital · GBUniversity of Southampton · GB

Funding

Department of Health NIHR-RP-02-12-012
6 · The paper itself

Abstract

backgroundAcute lower respiratory tract infection (LRTI) is one of the most common conditions managed internationally and is costly to health services and patients. Despite good evidence that antibiotics are not effective for improving the symptoms of uncomplicated LRTI, they are widely prescribed, contributing to antimicrobial resistance. Many of the symptoms observed in LRTI are mediated by inflammatory processes also observed in exacerbations of asthma, for which there is strong evidence of corticosteroid effectiveness. The primary aim of the OSAC (Oral Steroids for Acute Cough) Trial is to determine whether oral prednisolone (40 mg daily for 5 days) can reduce the duration of moderately bad (or worse) cough and the severity of all its associated symptoms on days 2 to 4 post-randomisation (day 1 is trial entry) by at least 20% in adults ≥18 years with acute LRTI presenting to primary care. METHODS/

designOSAC is a two-arm, multi-centre, placebo-controlled, randomised superiority trial. The target sample size is 436 patients, which allows for a 20% dropout rate. Patients will be recruited from primary care sites (General Practitioner surgeries) across England and followed up until symptom resolution. The two primary clinical outcomes are the duration of moderately bad (or worse) cough, and the severity of all its associated symptoms on days 2 to 4 post-randomisation. Secondary outcomes include: antibiotic consumption; symptom burden; adverse events; participant satisfaction with treatment and intention to consult for future similar illnesses. A parallel economic evaluation will investigate the cost-effectiveness of the intervention. DISCUSSION: Results from the OSAC trial will increase knowledge regarding the clinical and cost-effectiveness of corticosteroids for LRTI, and will establish the potential of a new treatment option that could substantially improve patient health. We have chosen a relatively high 'efficacy dose' as this will enable us to decide on the potential for further research into lower dose oral and/or inhaled corticosteroids. This trial will also contribute to a growing body of research investigating the natural course of this very common illness, as well as the effects of steroids on the undesirable inflammatory symptoms associated with infection.

trial registrationCurrent Controlled Trials ISRCTN57309858 (31 January 2013).

Indexed as

Clinical ProtocolsPrimary Health CareAcute DiseaseAdministration, OralAdrenal Cortex HormonesAdultCoughHealth Care CostsHumansNational Health ProgramsOutcome Assessment, Health CareRespiratory Tract InfectionsSample SizeTime FactorsAdrenal Cortex Hormones

Identifiers

PMID25885677
PMCPMC4358709
OpenAlexW1983263794

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.