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The Helicobacter Eradication Aspirin Trial (HEAT): a large simple randomised controlled trial using novel methodology in primary care

The Helicobacter Eradication Aspirin Trial (HEAT): a large simple randomised controlled trial using novel methodology in primary care
The Helicobacter Eradication Aspirin Trial (HEAT): a large simple randomised controlled trial using novel methodology in primary care
Background

Clinical trials measuring the effect of an intervention on clinical outcomes are more influential than those investigating surrogate measures but are costly. We developed methods to reduce costs substantially by using existing data in primary care systems, to ask whether Helicobacter pylori eradication would reduce the incidence of hospitalisation for ulcer bleeding in aspirin users.

Methods

The Helicobacter Eradication Aspirin Trial (HEAT) is a National Institute of Health Research-funded, double-blind placebo controlled randomised trial of the effects of H. pylori eradication on subsequent ulcer bleeding in infected individuals taking aspirin daily, conducted in practices across the whole of England, Wales and Northern Ireland. A bespoke web-based trial management system developed for the trial (and housed within the secure NHS Data Network) communicates directly with the HEAT Toolkit software downloaded at participating practices, which issues queries searching entry criteria (? 60 years, on chronic aspirin ? 325 mg daily, not on anti-ulcer therapy or non-steroidal anti-inflammatory drugs) for GP review of eligibility. Trial participation is invited using a highly secure automated online mail management system. Interested patients are seen once for consent and breath testing. Those with a positive test are randomised to eradication treatment (lansoprazole, clarithromycin, metronidazole) or placebo, with drug sent by post. Events are tracked by upload of accumulating information in the GP database, patient contact, review of National Hospital Episode Statistics and Office of National Statistics data.

Results

HEAT is the largest Clinical Research Network-supported drug trial, with 115,660 invitation letters sent from 850 practices, 22,922 volunteers, and 3038 H. pylori positive patients randomised to active or placebo treatment after 2.5 years of recruitment. 178 practices have performed their first follow-up data search to identify 21 potential endpoints to date.

Discussion

HEAT is important medically, because aspirin is so widely used, and methodologically, as a successful trial would show that large-scale studies of important clinical outcomes can be conducted at a fraction of the cost of those conducted by industry, which in turn will help to ensure that trials of primarily medical rather than commercial interest can be conducted successfully in the UK.
aspirin, helicobacter pylori, clinical trial, ulcer, bleed
1200-1204
Dumbleton, Jennifer S.
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Avery, Anthony J.
ba667df1-c7e8-4812-855c-8f5d8c37ed86
Coupland, Carol
6efd69d5-8f84-45ac-9777-d4b07feeb2e2
Hobbs, F.D.Richard
1ac8acf4-3ec2-418a-adb6-9b9b161b296f
Kendrick, Denise
33ad9db9-6d98-4e87-a2ad-323b289e3a16
Moore, Michael V.
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Morris, Clive
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Rubin, Greg P.
408cd38c-7cfc-49c2-8ca6-59df3fc29654
Smith, Murray D.
0a53a287-46bc-4a04-8d92-2da1d43475b5
Stevenson, Diane J.
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Hawkey, Chris J.
35460d3f-e2d4-4a59-b95b-d45303b403c9
Dumbleton, Jennifer S.
0fc448d4-e5f2-4e92-aeb7-3443853e44c7
Avery, Anthony J.
ba667df1-c7e8-4812-855c-8f5d8c37ed86
Coupland, Carol
6efd69d5-8f84-45ac-9777-d4b07feeb2e2
Hobbs, F.D.Richard
1ac8acf4-3ec2-418a-adb6-9b9b161b296f
Kendrick, Denise
33ad9db9-6d98-4e87-a2ad-323b289e3a16
Moore, Michael V.
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Morris, Clive
eccf88a9-1828-4390-ac36-258c2fec436e
Rubin, Greg P.
408cd38c-7cfc-49c2-8ca6-59df3fc29654
Smith, Murray D.
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Stevenson, Diane J.
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Hawkey, Chris J.
35460d3f-e2d4-4a59-b95b-d45303b403c9

Dumbleton, Jennifer S., Avery, Anthony J., Coupland, Carol, Hobbs, F.D.Richard, Kendrick, Denise, Moore, Michael V., Morris, Clive, Rubin, Greg P., Smith, Murray D., Stevenson, Diane J. and Hawkey, Chris J. (2015) The Helicobacter Eradication Aspirin Trial (HEAT): a large simple randomised controlled trial using novel methodology in primary care. EBioMedicine, 2 (9), 1200-1204. (doi:10.1016/j.ebiom.2015.07.012). (PMID:26501118)

Record type: Article

Abstract

Background

Clinical trials measuring the effect of an intervention on clinical outcomes are more influential than those investigating surrogate measures but are costly. We developed methods to reduce costs substantially by using existing data in primary care systems, to ask whether Helicobacter pylori eradication would reduce the incidence of hospitalisation for ulcer bleeding in aspirin users.

Methods

The Helicobacter Eradication Aspirin Trial (HEAT) is a National Institute of Health Research-funded, double-blind placebo controlled randomised trial of the effects of H. pylori eradication on subsequent ulcer bleeding in infected individuals taking aspirin daily, conducted in practices across the whole of England, Wales and Northern Ireland. A bespoke web-based trial management system developed for the trial (and housed within the secure NHS Data Network) communicates directly with the HEAT Toolkit software downloaded at participating practices, which issues queries searching entry criteria (? 60 years, on chronic aspirin ? 325 mg daily, not on anti-ulcer therapy or non-steroidal anti-inflammatory drugs) for GP review of eligibility. Trial participation is invited using a highly secure automated online mail management system. Interested patients are seen once for consent and breath testing. Those with a positive test are randomised to eradication treatment (lansoprazole, clarithromycin, metronidazole) or placebo, with drug sent by post. Events are tracked by upload of accumulating information in the GP database, patient contact, review of National Hospital Episode Statistics and Office of National Statistics data.

Results

HEAT is the largest Clinical Research Network-supported drug trial, with 115,660 invitation letters sent from 850 practices, 22,922 volunteers, and 3038 H. pylori positive patients randomised to active or placebo treatment after 2.5 years of recruitment. 178 practices have performed their first follow-up data search to identify 21 potential endpoints to date.

Discussion

HEAT is important medically, because aspirin is so widely used, and methodologically, as a successful trial would show that large-scale studies of important clinical outcomes can be conducted at a fraction of the cost of those conducted by industry, which in turn will help to ensure that trials of primarily medical rather than commercial interest can be conducted successfully in the UK.

Other
1-s2.0-S2352396415300670-main.pdf__tid=3e712a9e-c8ff-11e5-973d-00000aab0f27&acdnat=1454343609_c4f1baded4a565e5ab1a8c586d6273bb - Version of Record
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More information

Accepted/In Press date: 7 July 2015
e-pub ahead of print date: 10 July 2015
Published date: 9 September 2015
Keywords: aspirin, helicobacter pylori, clinical trial, ulcer, bleed
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 386757
URI: http://eprints.soton.ac.uk/id/eprint/386757
PURE UUID: 4ed33b27-69ec-48be-bc55-0c9ec23dc328
ORCID for Michael V. Moore: ORCID iD orcid.org/0000-0002-5127-4509

Catalogue record

Date deposited: 01 Feb 2016 16:24
Last modified: 15 Mar 2024 03:22

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Contributors

Author: Jennifer S. Dumbleton
Author: Anthony J. Avery
Author: Carol Coupland
Author: F.D.Richard Hobbs
Author: Denise Kendrick
Author: Clive Morris
Author: Greg P. Rubin
Author: Murray D. Smith
Author: Diane J. Stevenson
Author: Chris J. Hawkey

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