The University of Southampton
University of Southampton Institutional Repository

Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial

Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial
Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial

Background: Respiratory virus infection is a common cause of hospitalisation in adults. Rapid point-of-care testing (POCT) for respiratory viruses might improve clinical care by reducing unnecessary antibiotic use, shortening length of hospital stay, improving influenza detection and treatment, and rationalising isolation facility use; however, insufficient evidence exists to support its use over standard clinical care. We aimed to assess the effect of routine POCT on a broad range of clinical outcomes including antibiotic use.

Methods: In this pragmatic, parallel-group, open-label, randomised controlled trial, we enrolled adults (aged ≥18 years) within 24 h of presenting to the emergency department or acute medical unit of a large UK hospital with acuterespiratory illness or fever higher than 37·5°C (≤7 days duration), or both, over two winter seasons. Patients were randomly assigned (1:1), via an internet-based allocation sequence with random permuted blocks, to have a molecularPOC test for respiratory viruses or routine clinical care. The primary outcome was the proportion of patients who received antibiotics while hospitalised (up to 30 days). Secondary outcomes included duration of antibiotics, proportion of patients receiving single doses or brief courses of antibiotics, length of stay, antiviral use, isolation facility use, and safety. Analysis was by modified intention to treat, excluding patients who declined intervention or were withdrawn for protocol violations. This study is registered with ISRCTN, number 90211642, and has been completed.

Findings: Between Jan 15, 2015, and April 30, 2015, and between Oct 1, 2015, and April 30, 2016, we enrolled 720 patients (362 assigned to POCT and 358 to routine care). Six patients withdrew or had protocol violations. 301 (84%) of 360 patients in the POCT group received antibiotics compared with 294 (83%) of 354 controls (difference 0·6%, 95% CI −4·9 to 6·0; p=0·84). Mean duration of antibiotics did not differ between groups (7·2 days [SD 5·1] in the POCT group vs 7·7 days [4·9] in the control group; difference −0·4, 95% CI −1·2 to 0·4; p=0·32). 50 (17%) of 301 patients treated with antibiotics in the POCT group received single doses or brief courses of antibiotics (<48 h) compared with 26 (9%) of 294 patients in the control group (difference 7·8%, 95% CI 2·5 to 13·1; p=0·0047; number needed to test=13). Mean length of stay was shorter in the POCT group (5·7 days [SD 6·3]) than in the control group (6·8 days [7·7]; difference −1·1, 95% CI −2·2 to −0·3; p=0·0443). Appropriate antiviral treatment of influenza-positive patients was more common in the POCTgroup (52 [91%] of 57 patients) than in the control group (24 [65%] of 37 patients; difference 26·4%, 95% CI 9·6 to 43·2; p=0·0026; number needed to test=4). We found no differences in adverse outcomes between the groups (77 [21%] of 360 patients in the POCT group vs 88 [25%] of 354 patients in the control group; −3·5%, −9·7 to 2·7; p=0·29).

Interpretation: Routine use of molecular POCT for respiratory viruses did not reduce the proportion of patients treated with antibiotics. However, the primary outcome measure failed to capture differences in antibiotic use because many patients were started on antibiotics before the results of POCT could be made available. Although POCT was not associated with a reduction in the duration of antibiotics overall, more patients in the POCT group received single doses or brief courses of antibiotics than did patients in the control group. POCT was also associated with a reducedlength of stay and improved influenza detection and antiviral use, and appeared to be safe.

point-of-care diagnostics, influenza, adults, hospital admission, respiratory viruses, antibiotics, antivirals, length of hospital stay
2213-2600
401-411
Brendish, Nathan J.
d07b588f-4919-456d-8604-04efde7711fd
Malachira, Ahalya K.
c4df54f3-faca-4abb-b360-6555048c18f3
Armstrong, Lawrence
d4633459-0e43-4a10-938e-5b1a04f71d78
Houghton, Rebecca
5ec00f0e-49b1-4b6d-930e-9603370c3cc4
Aitken, Sandra
67961c02-ea10-4388-94d4-ae9ba58c625d
Nyimbili, Esther
29994ea1-79be-4d3a-b81c-55d334d14a3d
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Lillie, Patrick J.
3068afd9-e2bd-4c75-8ad3-e95b412f3456
Clark, Tristan W.
712ec18e-613c-45df-a013-c8a22834e14f
Brendish, Nathan J.
d07b588f-4919-456d-8604-04efde7711fd
Malachira, Ahalya K.
c4df54f3-faca-4abb-b360-6555048c18f3
Armstrong, Lawrence
d4633459-0e43-4a10-938e-5b1a04f71d78
Houghton, Rebecca
5ec00f0e-49b1-4b6d-930e-9603370c3cc4
Aitken, Sandra
67961c02-ea10-4388-94d4-ae9ba58c625d
Nyimbili, Esther
29994ea1-79be-4d3a-b81c-55d334d14a3d
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Lillie, Patrick J.
3068afd9-e2bd-4c75-8ad3-e95b412f3456
Clark, Tristan W.
712ec18e-613c-45df-a013-c8a22834e14f

Brendish, Nathan J., Malachira, Ahalya K., Armstrong, Lawrence, Houghton, Rebecca, Aitken, Sandra, Nyimbili, Esther, Ewings, Sean, Lillie, Patrick J. and Clark, Tristan W. (2017) Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. The Lancet Respiratory Medicine, 5 (5), 401-411. (doi:10.1016/S2213-2600(17)30120-0).

Record type: Article

Abstract

Background: Respiratory virus infection is a common cause of hospitalisation in adults. Rapid point-of-care testing (POCT) for respiratory viruses might improve clinical care by reducing unnecessary antibiotic use, shortening length of hospital stay, improving influenza detection and treatment, and rationalising isolation facility use; however, insufficient evidence exists to support its use over standard clinical care. We aimed to assess the effect of routine POCT on a broad range of clinical outcomes including antibiotic use.

Methods: In this pragmatic, parallel-group, open-label, randomised controlled trial, we enrolled adults (aged ≥18 years) within 24 h of presenting to the emergency department or acute medical unit of a large UK hospital with acuterespiratory illness or fever higher than 37·5°C (≤7 days duration), or both, over two winter seasons. Patients were randomly assigned (1:1), via an internet-based allocation sequence with random permuted blocks, to have a molecularPOC test for respiratory viruses or routine clinical care. The primary outcome was the proportion of patients who received antibiotics while hospitalised (up to 30 days). Secondary outcomes included duration of antibiotics, proportion of patients receiving single doses or brief courses of antibiotics, length of stay, antiviral use, isolation facility use, and safety. Analysis was by modified intention to treat, excluding patients who declined intervention or were withdrawn for protocol violations. This study is registered with ISRCTN, number 90211642, and has been completed.

Findings: Between Jan 15, 2015, and April 30, 2015, and between Oct 1, 2015, and April 30, 2016, we enrolled 720 patients (362 assigned to POCT and 358 to routine care). Six patients withdrew or had protocol violations. 301 (84%) of 360 patients in the POCT group received antibiotics compared with 294 (83%) of 354 controls (difference 0·6%, 95% CI −4·9 to 6·0; p=0·84). Mean duration of antibiotics did not differ between groups (7·2 days [SD 5·1] in the POCT group vs 7·7 days [4·9] in the control group; difference −0·4, 95% CI −1·2 to 0·4; p=0·32). 50 (17%) of 301 patients treated with antibiotics in the POCT group received single doses or brief courses of antibiotics (<48 h) compared with 26 (9%) of 294 patients in the control group (difference 7·8%, 95% CI 2·5 to 13·1; p=0·0047; number needed to test=13). Mean length of stay was shorter in the POCT group (5·7 days [SD 6·3]) than in the control group (6·8 days [7·7]; difference −1·1, 95% CI −2·2 to −0·3; p=0·0443). Appropriate antiviral treatment of influenza-positive patients was more common in the POCTgroup (52 [91%] of 57 patients) than in the control group (24 [65%] of 37 patients; difference 26·4%, 95% CI 9·6 to 43·2; p=0·0026; number needed to test=4). We found no differences in adverse outcomes between the groups (77 [21%] of 360 patients in the POCT group vs 88 [25%] of 354 patients in the control group; −3·5%, −9·7 to 2·7; p=0·29).

Interpretation: Routine use of molecular POCT for respiratory viruses did not reduce the proportion of patients treated with antibiotics. However, the primary outcome measure failed to capture differences in antibiotic use because many patients were started on antibiotics before the results of POCT could be made available. Although POCT was not associated with a reduction in the duration of antibiotics overall, more patients in the POCT group received single doses or brief courses of antibiotics than did patients in the control group. POCT was also associated with a reducedlength of stay and improved influenza detection and antiviral use, and appeared to be safe.

Text
ResPOC.R2.CLEAN - Accepted Manuscript
Download (68kB)

More information

Accepted/In Press date: 2 March 2017
e-pub ahead of print date: 5 April 2017
Published date: 5 May 2017
Keywords: point-of-care diagnostics, influenza, adults, hospital admission, respiratory viruses, antibiotics, antivirals, length of hospital stay
Organisations: Physical & Rehabilitation Health, Primary Care & Population Sciences, Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 407892
URI: https://eprints.soton.ac.uk/id/eprint/407892
ISSN: 2213-2600
PURE UUID: 445426d6-c106-492c-8fdb-a02585b0b454
ORCID for Nathan J. Brendish: ORCID iD orcid.org/0000-0002-9589-4937
ORCID for Sean Ewings: ORCID iD orcid.org/0000-0001-7214-4917
ORCID for Tristan W. Clark: ORCID iD orcid.org/0000-0001-6026-5295

Catalogue record

Date deposited: 28 Apr 2017 01:05
Last modified: 03 Dec 2019 06:10

Export record

Altmetrics

Contributors

Author: Nathan J. Brendish ORCID iD
Author: Ahalya K. Malachira
Author: Lawrence Armstrong
Author: Rebecca Houghton
Author: Sandra Aitken
Author: Esther Nyimbili
Author: Sean Ewings ORCID iD
Author: Patrick J. Lillie

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×