Evidence map›Paper›PMID 35164864›Full record

Trial reportTrials2022

Recruitment to a large scale randomised controlled clinical trial in primary care: the Helicobacter Eradication Aspirin Trial (HEAT).

Diane J Stevenson, Anthony J Avery, Carol Coupland, F D Richard Hobbs, Denise Kendrick, Michael V Moore, Clive Morris, Greg P Rubin, Murray D Smith, Christopher J Hawkey and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01506986 (Helicobacter Eradication to Prevent Ulcer Bleeding in Aspirin Users), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 28% 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.

NCT01506986 phase4completednot on this map

Helicobacter Eradication to Prevent Ulcer Bleeding in Aspirin Users: a Large Simple Randomised Controlled Trial

TypeinterventionalSponsorUniversity of NottinghamRan2012 to 2022Enrolled30,024ConditionsGastrointestinal Ulcer Haemorrhage, Bacterial Infection Due to Helicobacter Pylori (H. Pylori)ArmsLansoprazole 30mg, Clarithromycin 500mg, Metronidazole 400mg, Placebo lansoprazole 30mg, clarithromycin 500mg, metronidazole 400mg
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Eradication ofHealth technology assessment (Winchester, England) · 2025
    Trial
  2. 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

11 authors at 5 institutions in 1 country.

Diane J StevensonSTAR (Simple Trials for Academic Research) Unit, Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham, UK. diane.stevenson@nottingham.ac.uk.ORCID http://orcid.org/0000-0003-3533-1005
Anthony J AveryDivision of Primary Care, University of Nottingham, Nottingham, UK.
Carol CouplandDivision of Primary Care, University of Nottingham, Nottingham, UK.
F D Richard HobbsNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Denise KendrickDivision of Primary Care, University of Nottingham, Nottingham, UK.
Michael V MoorePrimary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK.
Clive MorrisTCR (Nottingham) Ltd., Langley Mill, Nottingham, UK.
Greg P RubinInstitute of Population Health Sciences, Newcastle University, Newcastle-upon-Tyne, UK.
Murray D SmithSchool of Health & Social Care, University of Lincoln, Lincoln, UK.
Christopher J HawkeySTAR (Simple Trials for Academic Research) Unit, Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham, UK.
Jennifer S DumbletonSTAR (Simple Trials for Academic Research) Unit, Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham, UK.
University of Nottingham · GBNewcastle University · GBUniversity of Lincoln · GBUniversity of Oxford · GBUniversity of Southampton · GB

Funding

National Institute for Health Research Health Technology Assessment programme 09/55/52
6 · The paper itself

Abstract

backgroundThe Helicobacter Eradication Aspirin Trial (HEAT) is a multicentre, double blind, randomised controlled trial investigating whether Helicobacter (H.) pylori eradication reduces hospitalisation for peptic ulcer bleeding. Recruited participants were aged 60 and over and taking aspirin (≤325 mg daily) for at least four months prior to consent. Based on results of a pilot study, a sample size calculation predicted 6600 H. pylori-positive randomised participants would be required, from 33,000 volunteers, recruited from 170,000 invited patients. Methodology was therefore designed for recruitment of large numbers of patients from primary care using a novel electronic search tool, automated mail-out and electronic follow-up. Recruitment started in 2012 and completed in 2017.

methodsAll participants were recruited from GP practices, with assistance from the UK Clinical Research Network (UKCRN). H. pylori-positive participants were randomised to one week of eradication treatment or placebo. Recruitment was managed using a bespoke web-based database that communicated directly with a programmed search tool downloaded at participating practices. The primary endpoint is hospitalisation due to peptic ulcer bleeding. The trial will end when 87 adjudicated events have occurred, identified from searches of GP databases, review of secondary care admission data and mortality data, and reported events from randomised participants and GPs.

resultsHEAT has recruited participants from 1208 GP practices across the UK. Of the 188,875 invitation letters sent, 38,771 returned expressions of interest. Of these, 30,166 patients were consented to the trial, of whom 5355 H. pylori-positive participants (17.8% of those consented) were randomised. Mean age at consent was 73.1 ± 6.9 (SD) years and 72.2% of participants were male. Of the randomised (H. pylori-positive) participants, 531 have died (as of 17 Sep 2020); none of the deaths was due to trial treatment.

conclusionThe HEAT trial methodology has demonstrated that recruitment of large numbers of patients from primary care is attainable, with the assistance of the UKCRN, and could be applied to other clinical outcomes studies.

trial registrationClinicalTrials.gov ; registration number NCT01506986 . Registered on 10 Jan 2012.

Indexed as

AspirinHelicobacterAgedHot TemperatureHumansMaleMiddle AgedPilot ProjectsPrimary Health CareTreatment OutcomeAspirinAspirinClinical research networksClinical trialDemographicsH. pyloriPrimary careRecruitmentUlcer bleeding

Identifiers

PMID35164864
PMCPMC8842965
OpenAlexW4213005651

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.