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

Recruitment to a large scale randomised controlled clinical trial in primary care: the Helicobacter Eradication Aspirin Trial (HEAT)
Recruitment to a large scale randomised controlled clinical trial in primary care: the Helicobacter Eradication Aspirin Trial (HEAT)
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 over 60 and taking aspirin (≤325mg daily) for at least four months. A pilot study predicted 6,600 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 from 1,208 GP practices across the UK. Of the 188,875 invitation letters sent, 38,771 expressions of interest were received. Of these, 30,166 patients were consented to the trial, of whom 5,355 H. pylori positive participants (17.8% of those consented) were randomised.
Mean age at consent was 73.1 ± 6.9 (SD) years and 72.1% of participants were male; 52.0% were ex-smokers and 5.8% were current smokers. 80% of consented participants were prescribed statins, 45% were in the BMI range 25-30 (overweight) and approximately 80% drank less than 14 units of alcohol per week. Of the randomised (H. pylori positive) participants, 386 have died (as of 12-Aug-2020); none of the deaths were 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.
Aspirin, Clinical research networks, Clinical trial, Demographics, H. pylori, Primary care, Recruitment, Ulcer bleeding
1745-6215
Stevenson, Diane J.
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Avery, Anthony J.
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Coupland, Carol
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Hobbs, F.D. Richard
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Kendrick, Denise
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Moore, Michael
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Morris, Clive
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Rubin, Greg P.
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Smith, Murray D.
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Hawley, Christopher J.
266b205e-5063-42e1-b0ef-df334b0c4819
Dumbleton, Jennifer S.
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Stevenson, Diane J.
6acab417-432d-4d9f-88c8-ec3ab90f6c42
Avery, Anthony J.
ba667df1-c7e8-4812-855c-8f5d8c37ed86
Coupland, Carol
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Hobbs, F.D. Richard
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Kendrick, Denise
33ad9db9-6d98-4e87-a2ad-323b289e3a16
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Morris, Clive
eccf88a9-1828-4390-ac36-258c2fec436e
Rubin, Greg P.
408cd38c-7cfc-49c2-8ca6-59df3fc29654
Smith, Murray D.
0a53a287-46bc-4a04-8d92-2da1d43475b5
Hawley, Christopher J.
266b205e-5063-42e1-b0ef-df334b0c4819
Dumbleton, Jennifer S.
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Stevenson, Diane J., Avery, Anthony J., Coupland, Carol, Hobbs, F.D. Richard, Kendrick, Denise, Moore, Michael, Morris, Clive, Rubin, Greg P., Smith, Murray D., Hawley, Christopher J. and Dumbleton, Jennifer S. (2022) Recruitment to a large scale randomised controlled clinical trial in primary care: the Helicobacter Eradication Aspirin Trial (HEAT). Trials, 23 (140), [140]. (doi:10.1186/s13063-022-06054-w).

Record type: Article

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 over 60 and taking aspirin (≤325mg daily) for at least four months. A pilot study predicted 6,600 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 from 1,208 GP practices across the UK. Of the 188,875 invitation letters sent, 38,771 expressions of interest were received. Of these, 30,166 patients were consented to the trial, of whom 5,355 H. pylori positive participants (17.8% of those consented) were randomised.
Mean age at consent was 73.1 ± 6.9 (SD) years and 72.1% of participants were male; 52.0% were ex-smokers and 5.8% were current smokers. 80% of consented participants were prescribed statins, 45% were in the BMI range 25-30 (overweight) and approximately 80% drank less than 14 units of alcohol per week. Of the randomised (H. pylori positive) participants, 386 have died (as of 12-Aug-2020); none of the deaths were 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.

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HEAT paper 2022[1]
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More information

Accepted/In Press date: 27 January 2022
Published date: 14 February 2022
Keywords: Aspirin, Clinical research networks, Clinical trial, Demographics, H. pylori, Primary care, Recruitment, Ulcer bleeding

Identifiers

Local EPrints ID: 455131
URI: http://eprints.soton.ac.uk/id/eprint/455131
ISSN: 1745-6215
PURE UUID: 3678a20a-79d8-4924-acc3-fe09d21eea68
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

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Date deposited: 10 Mar 2022 17:51
Last modified: 28 Apr 2022 01:54

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Contributors

Author: Diane J. Stevenson
Author: Anthony J. Avery
Author: Carol Coupland
Author: F.D. Richard Hobbs
Author: Denise Kendrick
Author: Michael Moore ORCID iD
Author: Clive Morris
Author: Greg P. Rubin
Author: Murray D. Smith
Author: Christopher J. Hawley
Author: Jennifer S. Dumbleton

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