Evidence map›Paper›PMID 27595142›Full record

Trial reportThe lancet. Gastroenterology & hepatology2016

Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial.

John G Williams, M Fasih Alam, Laith Alrubaiy, Ian Arnott, Clare Clement, David Cohen, John N Gordon, A Barney Hawthorne, Mike Hilton, Hayley A Hutchings and 10 more

Open access · hybridAbstract readComparative StudyMulticenter StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. Gastroenterology & hepatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 111 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 11 pooled it
19.8field-weighted citation impact, top 1% 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

111 citing papers in PubMed, 11 syntheses or guidelines pooled it, 253 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  5. Pooled it
  6. [Living guideline on ulcerative colitis].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2022
    Guideline
  7. Ulcerative Colitis-Diagnostic and Therapeutic Algorithms.Deutsches Arzteblatt international · 2020
    Pooled it
  8. Guideline
  9. Pooled it
  10. Pooled it
  11. Effect of Accelerated Infliximab Induction on Short- and Long-term Outcomes of Acute Severe Ulcerative Colitis: A Retrospective Multicenter Study and Meta-analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2019
    Pooled it
  12. Trial
  13. Trial
  14. Trial
  15. Article
  16. Review
  17. The Emerging Role of Ultrasonography in Ulcerative Colitis.Diagnostics (Basel, Switzerland) · 2026
    Review
  18. Article
  19. Article
  20. Article

51 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 10 institutions in 1 country.

John G WilliamsSwansea University Medical School, Swansea, UK.
M Fasih AlamCollege of Human and Health Sciences, Swansea University, Swansea, UK.
Laith AlrubaiySwansea University Medical School, Swansea, UK.
Ian ArnottNHS Lothian, Western General Hospital, Edinburgh, UK.
Clare ClementSwansea University Medical School, Swansea, UK.
David CohenUniversity of South Wales, Pontypridd, UK.
John N GordonHampshire Hospitals NHS Foundation Trust, Royal Hampshire County Hospital, Winchester, UK.
A Barney HawthorneCardiff and Vale University Health Board, University Hospital of Wales, Cardiff, UK.
Mike HiltonSwansea University Medical School, Swansea, UK.
Hayley A HutchingsSwansea University Medical School, Swansea, UK.
Aida U JawhariNational Institute for Health Research (NIHR), Nottingham Digestive Diseases Biomedical Research Unit, Nottingham University Hospital NHS Trust, Nottingham, UK.
Mirella LongoCollege of Human and Health Sciences, Swansea University, Swansea, UK.
John MansfieldThe Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
Jayne M MorganSwansea University Medical School, Swansea, UK.
Frances RapportSwansea University Medical School, Swansea, UK.
Anne C SeagroveSwansea University Medical School, Swansea, UK.
Shaji SebastianHull and East Yorkshire Hospitals NHS Trust, Hull, UK.
Ian ShawGloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.
Simon P L TravisTranslational Gastroenterology Unit, Oxford University Hospitals NHS Trust, Oxford, UK.
Alan WatkinsSwansea University Medical School, Swansea, UK.
Swansea University · GBGloucestershire Hospitals NHS Foundation Trust · GBHampshire Hospitals NHS Foundation Trust · GBHull and East Yorkshire Hospitals NHS Trust · GBNational Institute for Health Research · GBOxford University Hospitals NHS Trust · GBRoyal Victoria Infirmary · GBUniversity Hospital of Wales · GBUniversity of South Wales · GBWestern General Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfliximab and ciclosporin are of similar efficacy in treating acute severe ulcerative colitis, but there has been no comparative evaluation of their relative clinical effectiveness and cost-effectiveness.

methodsIn this mixed methods, open-label, pragmatic randomised trial, we recruited consenting patients aged 18 years or older at 52 district general and teaching hospitals in England, Scotland, and Wales who had been admitted, unscheduled, with severe ulcerative colitis and failed to respond to intravenous hydrocortisone within about 5 days. Patients were randomly allocated (1:1) to receive either infliximab (5 mg/kg intravenous infusion given over 2 h at baseline, and again at 2 weeks and 6 weeks after the first infusion) or ciclosporin (2 mg/kg per day by continuous infusion for up to 7 days, followed by twice-daily tablets delivering 5·5 mg/kg per day for 12 weeks). Randomisation used a web-based password-protected site, with a dynamic algorithm to generate allocations on request, thus protecting against investigator preference or other subversion, while ensuring that each trial group was balanced by centre, which was the only stratification used. Local investigators and participants were aware of the treatment allocated, but the chief investigator and analysts were masked. Analysis was by treatment allocated. The primary outcome was quality-adjusted survival-ie, the area under the curve (AUC) of scores from the Crohn's and Ulcerative Colitis Questionnaire (CUCQ) completed by participants at baseline, 3 months, and 6 months, then every 6 months from 1 year to 3 years. This trial is registered with the ISRCTN Registry, number ISRCTN22663589.

findingsBetween June 17, 2010, and Feb 26, 2013, 270 patients were recruited. 135 patients were allocated to the infliximab group and 135 to the ciclosporin group. 121 (90%) patients in each group were included in the analysis of the primary outcome. There was no significant difference between groups in quality-adjusted survival (mean AUC 564·0 [SD 241·9] in the infliximab group

interpretationThere was no significant difference between ciclosporin and infliximab in clinical effectiveness.

fundingNIHR Health Technology Assessment programme.

Indexed as

AdolescentAdultAgedAged, 80 and overArea Under CurveColitis, UlcerativeCost-Benefit AnalysisCyclosporineDrug Administration ScheduleFemaleFollow-Up StudiesHumansHydrocortisoneImmunosuppressive AgentsInfliximabInfusions, IntravenousCyclosporineHydrocortisoneImmunosuppressive AgentsInfliximab

Identifiers

PMID27595142
PMCPMC4994668
OpenAlexW2462748655

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.