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Oral corticosteroid use for clinical and cost-effective symptom relief of sore throat: study protocol for a randomized controlled trial

Oral corticosteroid use for clinical and cost-effective symptom relief of sore throat: study protocol for a randomized controlled trial
Oral corticosteroid use for clinical and cost-effective symptom relief of sore throat: study protocol for a randomized controlled trial
Background

Management of acute sore throat poses a significant burden on UK general practices, with almost 10% of registered patients attending their GP with sore throat every year. Nearly half of all patients presenting with acute sore throat are treated with antibiotics, despite their limited effect. In a recent systematic review we demonstrated that a single dose of steroids reduced the severity and time to resolution of sore throat. However, all of the trials included looked at the use of steroids alongside antibiotics and only one was in a primary care setting. This trial aims to assess the efficacy and cost-effectiveness of a single oral dose of corticosteroids on symptoms of sore throat in patients receiving either a delayed antibiotic prescription or no antibiotics at all in UK primary care.

Methods/Design

A double-blind, two arm, randomized, placebo controlled trial in adults (?18 years of age) presenting to primary care with acute sore throat (<seven days). Participants are recruited on the day of presentation to their GP practice. GPs or nurses assess eligibility, record baseline clinical features and obtain a throat swab for bacterial culture. Participants are being randomized to treatment arms at a ratio of 1:1. Treatment arms will be stratified according to whether patients are being given a delayed antibiotic prescription or no antibiotic prescription and by recruiting centre (Oxford, Bristol or Southampton). Outcome data is being collected at 24 and 48 hours via text message or telephone call, from days 0 to 7 using a patient symptom diary and at one month via a GP notes review.

Discussion

This will be the first randomized controlled trial of oral corticosteroids in adults presenting to primary care with sore throat in the UK, and the first to examine the clinical and cost-effectiveness of oral corticosteroids for the treatment of sore throat in the absence of antibiotics.

Trial registration

This trial is registered with Current Controlled Trials on 26 March 2013, registration number: ISRCTN17435450.
sore throat, steroid, antibiotics, delayed antibiotic prescription, dexamethasone, same day recruitment, adults, randomized, placebo-controlled
1745-6215
1-13
Cook, Johanna
2eb21e4e-2058-49ce-99a2-262d438bf988
Hayward, Gail
91362d6f-3c3b-4eae-8fc8-1571ccf184c1
Thompson, Matthew
ba689d1b-f5e2-4be3-8935-720f682c44c0
Hay, Alastair D.
bfae9e44-ae9b-473c-923f-1dea50747023
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Harman, Kim
de036b2f-da30-4cb7-bfaf-d709e84ca825
Wolstenholme, Jane
6452d0c9-354d-4e2b-a03c-e5f9d42212fe
Perera, Rafael
e99a2819-c326-461c-8526-980b64458c22
Voysey, Merryn
fd433353-cd7b-41af-bc72-69781e8a0f81
Allen, Julie
f478888a-0653-4505-acea-1134b5d80a1c
Breen, Maria
9e8651fc-1ac8-4405-9f1d-5db4147c87f8
Heneghan, Carl
ab54c700-8c86-420a-98b9-45e071b1c842
Cook, Johanna
2eb21e4e-2058-49ce-99a2-262d438bf988
Hayward, Gail
91362d6f-3c3b-4eae-8fc8-1571ccf184c1
Thompson, Matthew
ba689d1b-f5e2-4be3-8935-720f682c44c0
Hay, Alastair D.
bfae9e44-ae9b-473c-923f-1dea50747023
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Harman, Kim
de036b2f-da30-4cb7-bfaf-d709e84ca825
Wolstenholme, Jane
6452d0c9-354d-4e2b-a03c-e5f9d42212fe
Perera, Rafael
e99a2819-c326-461c-8526-980b64458c22
Voysey, Merryn
fd433353-cd7b-41af-bc72-69781e8a0f81
Allen, Julie
f478888a-0653-4505-acea-1134b5d80a1c
Breen, Maria
9e8651fc-1ac8-4405-9f1d-5db4147c87f8
Heneghan, Carl
ab54c700-8c86-420a-98b9-45e071b1c842

Cook, Johanna, Hayward, Gail, Thompson, Matthew, Hay, Alastair D., Moore, Michael, Little, Paul, Harman, Kim, Wolstenholme, Jane, Perera, Rafael, Voysey, Merryn, Allen, Julie, Breen, Maria and Heneghan, Carl (2014) Oral corticosteroid use for clinical and cost-effective symptom relief of sore throat: study protocol for a randomized controlled trial. Trials, 15 (365), 1-13. (doi:10.1186/1745-6215-15-365). (PMID:25238785)

Record type: Article

Abstract

Background

Management of acute sore throat poses a significant burden on UK general practices, with almost 10% of registered patients attending their GP with sore throat every year. Nearly half of all patients presenting with acute sore throat are treated with antibiotics, despite their limited effect. In a recent systematic review we demonstrated that a single dose of steroids reduced the severity and time to resolution of sore throat. However, all of the trials included looked at the use of steroids alongside antibiotics and only one was in a primary care setting. This trial aims to assess the efficacy and cost-effectiveness of a single oral dose of corticosteroids on symptoms of sore throat in patients receiving either a delayed antibiotic prescription or no antibiotics at all in UK primary care.

Methods/Design

A double-blind, two arm, randomized, placebo controlled trial in adults (?18 years of age) presenting to primary care with acute sore throat (<seven days). Participants are recruited on the day of presentation to their GP practice. GPs or nurses assess eligibility, record baseline clinical features and obtain a throat swab for bacterial culture. Participants are being randomized to treatment arms at a ratio of 1:1. Treatment arms will be stratified according to whether patients are being given a delayed antibiotic prescription or no antibiotic prescription and by recruiting centre (Oxford, Bristol or Southampton). Outcome data is being collected at 24 and 48 hours via text message or telephone call, from days 0 to 7 using a patient symptom diary and at one month via a GP notes review.

Discussion

This will be the first randomized controlled trial of oral corticosteroids in adults presenting to primary care with sore throat in the UK, and the first to examine the clinical and cost-effectiveness of oral corticosteroids for the treatment of sore throat in the absence of antibiotics.

Trial registration

This trial is registered with Current Controlled Trials on 26 March 2013, registration number: ISRCTN17435450.

Text
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More information

Published date: 18 September 2014
Keywords: sore throat, steroid, antibiotics, delayed antibiotic prescription, dexamethasone, same day recruitment, adults, randomized, placebo-controlled
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 372646
URI: https://eprints.soton.ac.uk/id/eprint/372646
ISSN: 1745-6215
PURE UUID: 7491ed29-cdee-42bb-bbd1-a4d703cf623b
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509
ORCID for Kim Harman: ORCID iD orcid.org/0000-0002-5173-7753

Catalogue record

Date deposited: 11 Dec 2014 16:22
Last modified: 20 Jul 2019 00:57

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Contributors

Author: Johanna Cook
Author: Gail Hayward
Author: Matthew Thompson
Author: Alastair D. Hay
Author: Michael Moore ORCID iD
Author: Paul Little
Author: Kim Harman ORCID iD
Author: Jane Wolstenholme
Author: Rafael Perera
Author: Merryn Voysey
Author: Julie Allen
Author: Maria Breen
Author: Carl Heneghan

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