Evidence map›Paper›PMID 31036048›Full record

ArticleTrials2019

Clarithromycin and endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps: study protocol for the MACRO randomised controlled trial.

Carl Philpott, Steffi le Conte, David Beard, Jonathan Cook, William Sones, Steve Morris, Caroline S Clarke, Mike Thomas, Paul Little, Jane Vennik and 9 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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

7 citing papers in PubMed.

  1. Trial
  2. Investigation into Antibiotic Resistance Profiles ofInfection and drug resistance · 2025
    Article
  3. Article
  4. Article
  5. Observational
  6. Article
  7. A comparison of international clinical practice guidelines on adult chronic rhinosinusitis shows considerable variability of recommendations for diagnosis and treatment.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2020
    Review
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

19 authors.

Carl PhilpottNorwich Medical School, Chancellor's Drive, University of East Anglia, Norwich, UK. C.Philpott@uea.ac.uk.ORCID http://orcid.org/0000-0002-1125-3236
Steffi le ConteSITU, University of Oxford, Oxford, UK.
David BeardSITU, University of Oxford, Oxford, UK.
Jonathan CookSITU, University of Oxford, Oxford, UK.
William SonesSITU, University of Oxford, Oxford, UK.
Steve MorrisDepartment of Applied Health Research, University College London, London, UK.
Caroline S ClarkeResearch Department of Primary Care and Population Health, University College London, London, UK.
Mike ThomasUniversity of Southampton, Southampton, UK.
Paul LittleUniversity of Southampton, Southampton, UK.
Jane VennikUniversity of Southampton, Southampton, UK.
Valerie LundUCL Ear Institute, University College London, London, UK.
Helen BlackshawevidENT, UCL Ear Institute, University College London, London, UK.
Anne SchilderevidENT, UCL Ear Institute, University College London, London, UK.
Stephen DurhamFaculty of Medicine, National Heart & Lung Institute, Imperial College London, London, UK.
Spiros DenaxasInstitute of Health Informatics, University College London, London, UK.
James CarpenterLondon School of Hygiene and Tropical Medicine, University College London, London, UK.
James BoardmanFifth Sense, Sanderum House, 38 Oakley Road, Chinnor, Oxfordshire, OX39 4TW, UK.
Claire HopkinsENT Department, Guy's and St Thomas' NHS Foundation Trust, London, UK.
MACRO programme team

Funding

Department of Health NIHR-RP-011-045Department of Health RP-PG-0614-20011Medical Research Council MR/K006584/1Programme Grants for Applied Research RP-PG-0614-20011
6 · The paper itself

Abstract

backgroundChronic rhinosinusitis (CRS) is a common source of ill health; 11% of UK adults reported CRS symptoms in a worldwide population study. Guidelines are conflicting regarding whether antibiotics should be included in primary medical management, reflecting the lack of evidence in systematic reviews. Insufficient evidence to inform the role of surgery contributes to a fivefold variation in UK intervention rates. The objective of this trial is to establish the comparative effectiveness of endoscopic sinus surgery (ESS) or a prolonged course of antibiotics (clarithromycin) in adult patients with CRS in terms of symptomatic improvement and costs to the National Health Service compared with standard medical care (intranasal medication) at 6 months. METHODS/

designA three-arm parallel-group trial will be conducted with patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care). They will be randomised to receive: (1) intranasal medication plus ESS, (2) intranasal medication plus clarithromycin (250 mg) or (3) intranasal medication plus a placebo. Intranasal medication (current standard medical care) is defined as a spray or drops of intranasal corticosteroids and saline irrigations. The primary outcome measure is the SNOT-22 questionnaire, which assesses disease-specific health-related quality of life. The study sample size is 600. Principal analyses will be according to the randomised groups irrespective of compliance. The trial will be conducted in at least 16 secondary or tertiary care centres with an internal pilot at six sites for 6 months. DISCUSSION: The potential cardiovascular side effects of macrolide antibiotics have been recently highlighted. The effectiveness of antibiotics will be established through this trial, which may help to reduce unnecessary usage and potential morbidity. If ESS is shown to be clinically effective and cost-effective, the trial may encourage earlier intervention. In contrast, if it is shown to be ineffective, then there should be a significant reduction in surgery rates. The trial results will feed into the other components of the MACRO research programme to establish best practice for the management of adults with CRS and design the ideal patient pathway across primary and secondary care.

trial registrationISRCTN36962030 . Registered on 17 October 2018.

Indexed as

EndoscopyAdministration, OralAnti-Bacterial AgentsChronic DiseaseClarithromycinComparative Effectiveness ResearchDrug Administration ScheduleFemaleHumansMaleMulticenter Studies as TopicNasal PolypsNasal Surgical ProceduresPilot ProjectsRandomized Controlled Trials as TopicRhinitisAnti-Bacterial AgentsClarithromycinchronic rhinosinusitisclarithromycinendoscopic sinus surgeryrandomised controlled trial

Identifiers

PMID31036048
PMCPMC6489242

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.