Evidence map›Paper›PMID 25748415›Full record

Trial reportBMJ open2015

Adherence-adjusted estimates of benefits and harms from treatment with amoxicillin for LRTI: secondary analysis of a 12-country randomised placebo-controlled trial using randomisation-based efficacy estimators.

David Gillespie, Kerenza Hood, Daniel Farewell, Christopher C Butler, Theo Verheij, Herman Goossens, Beth Stuart, Mark Mullee, Paul Little, GRACE consortium

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Bronchitis (acute).BMJ clinical evidence · 2015
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. 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

10 authors at 5 institutions in 3 countries.

David GillespieSouth East Wales Trials Unit (SEWTU), Institute of Primary Care & Public Health, Cardiff University School of Medicine, Cardiff, UK.
Kerenza HoodSouth East Wales Trials Unit (SEWTU), Institute of Primary Care & Public Health, Cardiff University School of Medicine, Cardiff, UK.
Daniel FarewellInstitute of Primary Care & Public Health, Cardiff University School of Medicine, Cardiff, UK.
Christopher C ButlerInstitute of Primary Care & Public Health, Cardiff University School of Medicine, Cardiff, UK Department of Primary Care Health Sciences, Oxford University, Oxford, UK.
Theo VerheijUniversity Medical Center Utrecht, Julius Center for Health, Sciences and Primary Care, Utrecht, The Netherlands.
Herman GoossensLaboratory of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.
Beth StuartPrimary Care and Population Sciences Division, University of Southampton, Southampton, UK.
Mark MulleePrimary Care and Population Sciences Division, University of Southampton, Southampton, UK.
Paul LittleDepartment of Primary Medical Care, Aldermoor Health Centre, Southampton, UK.
GRACE consortium
Cardiff University · GBUniversity of Southampton · GBUniversity Medical Center Utrecht · NLUniversity of Antwerp · BEUniversity of Oxford · GB

Funding

Medical Research Council G0902108
6 · The paper itself

Abstract

objectivesEstimate the efficacy of amoxicillin for acute uncomplicated lower-respiratory-tract infection (LRTI) in primary care and demonstrate the use of randomisation-based efficacy estimators.

designSecondary analysis of a two-arm individually-randomised placebo-controlled trial.

settingPrimary care practices in 12 European countries.

participantsPatients aged 18 or older consulting with an acute LRTI in whom pneumonia was not suspected by the clinician.

interventionsAmoxicillin (two 500 mg tablets three times a day for 7 days) or matched placebo.

main outcome measuresClinician-rated symptom severity between days 2-4; new/worsening symptoms and presence of side effects at 4-weeks. Adherence was captured using self-report and tablet counts.

results2061 participants were randomised to the amoxicillin or placebo group. On average, 88% of the prescribed amoxicillin was taken. The original analysis demonstrated small increases in both benefits and harms from amoxicillin. Minor improvements in the benefits of amoxicillin were observed when an adjustments for adherence were made (mean difference in symptom severity -0.08, 95% CI -0.17 to 0.01, OR for new/worsening symptoms 0.81, 95% CI 0.66 to 0.98) as well as minor increases in harms (OR for side effects 1.32, 95% CI 1.12 to 1.57).

conclusionsAdherence to amoxicillin was high, and the findings from the original analysis were robust to non-adherence. Participants consulting to primary care with an acute uncomplicated LRTI can on average expect minor improvements in outcome from taking amoxicillin. However, they are also at an increased risk of experiencing side effects. TRIAL REGISTRATION NUMBERS: Eudract-CT 2007-001586-15 and ISRCTN52261229. The trial was registered at EudraCT in 2007 due to an administrative misunderstanding that EudraCT was a suitable registry--which it was not in 2007, but has become since. On discovery of this error, the trial was also registered at ISRCTN (January 2009). Trial procedures did not change between the two registrations.

Indexed as

AmoxicillinAnti-Bacterial AgentsDrug-Related Side Effects and Adverse ReactionsMedication AdherenceAcute DiseaseAdultAgedEuropeFemaleHumansMalePneumoniaPrimary Health CareRespiratory Tract InfectionsRisk FactorsAmoxicillinAnti-Bacterial AgentsPRIMARY CARERESPIRATORY MEDICINE (see Thoracic Medicine)STATISTICS & RESEARCH METHODS

Identifiers

PMID25748415
PMCPMC4360594
OpenAlexW2151810591

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.