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General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial

General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial
General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial
Background
Most patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care are prescribed an antibiotic, which may not always be appropriate and may cause harm. C-reactive protein (CRP) is an acute-phase biomarker that can be rapidly measured at the point of care and may predict benefit from antibiotic treatment in AECOPD. It is not clear whether the addition of a CRP point-of-care test (POCT) to clinical assessment leads to a reduction in antibiotic consumption without having a negative impact on COPD health status.

Methods/design
This is a multicentre, individually randomised controlled trial (RCT) aiming to include 650 participants with a diagnosis of AECOPD in primary care. Participants will be randomised to be managed according to usual care (control) or with the addition of a CRP POCT to guide antibiotic prescribing. Antibiotic consumption for AECOPD within 4 weeks post randomisation and COPD health status (total score) measured by the Clinical COPD Questionnaire (CCQ) at 2 weeks post randomisation will be co-primary outcomes. Primary analysis (by intention-to-treat) will determine differences in antibiotic consumption for superiority and COPD health status for non-inferiority. Secondary outcomes include: COPD health status, CCQ domain scores, use of other COPD treatments (weeks 1, 2 and 4), EQ-5D utility scores (weeks 1, 2 and 4 and month 6), disease-specific, health-related quality of life (HRQoL) at 6 months, all-cause antibiotic consumption (antibiotic use for any condition) during first 4 weeks post randomisation, total antibiotic consumption (number of days during first 4 weeks of antibiotic consumed for AECOPD/any reason), antibiotic prescribing at the index consultation and during following 4 weeks, adverse effects over the first 4 weeks, incidence of pneumonia (weeks 4 and 6 months), health care resource use and cost comparison over the 6 months following randomisation. Prevalence and resistance profiles of bacteria will be assessed using throat and sputum samples collected at baseline and 4-week follow-up. A health economic evaluation and qualitative process evaluation will be carried out.

Discussion
If shown to be effective (i.e. leads to a reduction in antibiotic use with no worse COPD health status), the use of the CRP POCT could lead to better outcomes for patients with AECOPD and help reduce selective pressures driving the development of antimicrobial resistance. PACE will be one of the first studies to evaluate the cost-effectiveness of a POCT biomarker to guide clinical decision-making in primary care on patient-reported outcomes, antibiotic prescribing and antibiotic resistance for AECOPD.
1745-6215
Bates, Janine
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Francis, Nick A.
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White, Patrick
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Gillespie, David
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Thomas-Jones, Emma
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Breen, Rachel
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Kirby, Nigel
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Hood, Kerry
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Gal, Micaela
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Phillips, Rhiannon
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Naik, Gurudutt
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Cals, Jochen
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Llor, Carl
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Melbye, Hasse
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Wootton, Mandy
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Riga, Evgenia
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Cochrane, Ann
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Howe, Robin
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Fitzsimmons, Deborah
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Sewell, Bernadette
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Alam, Mohammed Fasihul
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Butler, Christopher C.
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Bates, Janine
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Francis, Nick A.
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White, Patrick
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Gillespie, David
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Thomas-Jones, Emma
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Breen, Rachel
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Kirby, Nigel
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Hood, Kerry
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Gal, Micaela
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Phillips, Rhiannon
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Naik, Gurudutt
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Cals, Jochen
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Llor, Carl
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Melbye, Hasse
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Wootton, Mandy
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Riga, Evgenia
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Cochrane, Ann
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Howe, Robin
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Fitzsimmons, Deborah
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Sewell, Bernadette
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Alam, Mohammed Fasihul
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Butler, Christopher C.
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Bates, Janine, Francis, Nick A., White, Patrick, Gillespie, David, Thomas-Jones, Emma, Breen, Rachel, Kirby, Nigel, Hood, Kerry, Gal, Micaela, Phillips, Rhiannon, Naik, Gurudutt, Cals, Jochen, Llor, Carl, Melbye, Hasse, Wootton, Mandy, Riga, Evgenia, Cochrane, Ann, Howe, Robin, Fitzsimmons, Deborah, Sewell, Bernadette, Alam, Mohammed Fasihul and Butler, Christopher C. (2017) General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial. Trials, 18, [442]. (doi:10.1186/s13063-017-2144-8).

Record type: Article

Abstract

Background
Most patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care are prescribed an antibiotic, which may not always be appropriate and may cause harm. C-reactive protein (CRP) is an acute-phase biomarker that can be rapidly measured at the point of care and may predict benefit from antibiotic treatment in AECOPD. It is not clear whether the addition of a CRP point-of-care test (POCT) to clinical assessment leads to a reduction in antibiotic consumption without having a negative impact on COPD health status.

Methods/design
This is a multicentre, individually randomised controlled trial (RCT) aiming to include 650 participants with a diagnosis of AECOPD in primary care. Participants will be randomised to be managed according to usual care (control) or with the addition of a CRP POCT to guide antibiotic prescribing. Antibiotic consumption for AECOPD within 4 weeks post randomisation and COPD health status (total score) measured by the Clinical COPD Questionnaire (CCQ) at 2 weeks post randomisation will be co-primary outcomes. Primary analysis (by intention-to-treat) will determine differences in antibiotic consumption for superiority and COPD health status for non-inferiority. Secondary outcomes include: COPD health status, CCQ domain scores, use of other COPD treatments (weeks 1, 2 and 4), EQ-5D utility scores (weeks 1, 2 and 4 and month 6), disease-specific, health-related quality of life (HRQoL) at 6 months, all-cause antibiotic consumption (antibiotic use for any condition) during first 4 weeks post randomisation, total antibiotic consumption (number of days during first 4 weeks of antibiotic consumed for AECOPD/any reason), antibiotic prescribing at the index consultation and during following 4 weeks, adverse effects over the first 4 weeks, incidence of pneumonia (weeks 4 and 6 months), health care resource use and cost comparison over the 6 months following randomisation. Prevalence and resistance profiles of bacteria will be assessed using throat and sputum samples collected at baseline and 4-week follow-up. A health economic evaluation and qualitative process evaluation will be carried out.

Discussion
If shown to be effective (i.e. leads to a reduction in antibiotic use with no worse COPD health status), the use of the CRP POCT could lead to better outcomes for patients with AECOPD and help reduce selective pressures driving the development of antimicrobial resistance. PACE will be one of the first studies to evaluate the cost-effectiveness of a POCT biomarker to guide clinical decision-making in primary care on patient-reported outcomes, antibiotic prescribing and antibiotic resistance for AECOPD.

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Accepted/In Press date: 14 August 2017
Published date: 29 September 2017

Identifiers

Local EPrints ID: 436491
URI: http://eprints.soton.ac.uk/id/eprint/436491
ISSN: 1745-6215
PURE UUID: 375c0611-e8e0-4b1e-b457-6139ce68406c
ORCID for Nick A. Francis: ORCID iD orcid.org/0000-0001-8939-7312

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Date deposited: 11 Dec 2019 17:30
Last modified: 09 Jan 2022 04:08

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Contributors

Author: Janine Bates
Author: Nick A. Francis ORCID iD
Author: Patrick White
Author: David Gillespie
Author: Emma Thomas-Jones
Author: Rachel Breen
Author: Nigel Kirby
Author: Kerry Hood
Author: Micaela Gal
Author: Rhiannon Phillips
Author: Gurudutt Naik
Author: Jochen Cals
Author: Carl Llor
Author: Hasse Melbye
Author: Mandy Wootton
Author: Evgenia Riga
Author: Ann Cochrane
Author: Robin Howe
Author: Deborah Fitzsimmons
Author: Bernadette Sewell
Author: Mohammed Fasihul Alam
Author: Christopher C. Butler

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