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, Jennifer S. Dumbleton

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

Background
The 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.

Methods
All 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.

Results
HEAT 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.

Conclusion
The 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.
Original languageEnglish
Article number140
Number of pages16
JournalTrials
Volume23
Issue number1
Early online date14 Feb 2022
DOIs
Publication statusPublished - 01 Dec 2022
Externally publishedYes

Keywords

  • Aspirin
  • Clinical research networks
  • Clinical trial
  • Demographics
  • H. pylori
  • Primary care
  • Recruitment
  • Ulcer bleeding

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