• English
    • Welsh
  • English 
    • English
    • Welsh
  • Login
Search DSpace:
  • Home
  • Research at Cardiff Met
  • Library Services
  • Contact Us
View item 
  • DSpace home
  • Cardiff School of Sport and Health Sciences
  • Health and Risk Management
  • View item
  • DSpace home
  • Cardiff School of Sport and Health Sciences
  • Health and Risk Management
  • View item
JavaScript is disabled for your browser. Some features of this site may not work without it.

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

Thumbnail
Author
Bates, J.
Francis, N.A.
White, P.
Gillespie, D.
Thomas-Jones, E.
Breen, R.
Kirby, N.
Hood, K.
Gal, M.
Phillips, Rhiannon
Naik, G.
Date
2017-09-29
Acceptance date
2017-08-14
Type
Article
Publisher
BMC (Springer Nature)
ISSN
1745-6215
Metadata
Show full item record
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.
Journal/conference proceeding
Trials;
Citation
Bates, J., Francis, N.A., White, P., Gillespie, D., Thomas-Jones, E., Breen, R., Kirby, N., Hood, K., Gal, M., Phillips, R. and Naik, G. (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(1), p.442.
URI
http://hdl.handle.net/10369/10760
DOI
https://doi.org/10.1186/s13063-017-2144-8
Description
Article published in Trials available open access at https://doi.org/10.1186/s13063-017-2144-8
Collections
  • Health and Risk Management [392]

Related items

Showing items related by title, author, subject and abstract.

  • Thumbnail

    C-reactive protein point-of-care testing for safely reducing antibiotics for acute exacerbations of chronic obstructive pulmonary disease: the PACE RCT 

    Francis, Nick; Gillespie, David; White, Patrick; Bates, Janine; Lowe, Rachel; Sewell, B.; Phillips, Rhiannon (NIHR Journals Library, 2020-03)
    Background: Most patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care are prescribed antibiotics, but these may not be beneficial, and they can cause side effects ...
  • Thumbnail

    C-Reactive Protein-guided antibiotic prescribing for COPD exacerbations: a qualitative evaluation 

    Phillips, Rhiannon; Stanton, Helen; Singh-Hehta, Amina; Gillespie, David; Bates, Janine; Gal, Micaela; Thomas-Jones, Emma; Lowe, Rachel; Hood, Kerenza; Llor, Carl; Melbye, Hasse; Cals, Jochen; White, Patrick; Butler, Christopher C.; Francis, Nick (Royal College of General Practitioners, 2020-05-18)
    Background: Antibiotics are prescribed to over 70% of patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The PACE randomised controlled trial found that a ...
  • Thumbnail

    C-Reactive Protein Testing to Guide Antibiotic Prescribing for COPD Exacerbations 

    Butler, Christopher C.; Gillespie, David; White, Patrick; Bates, Janine; Lowe, Rachel; Thomas-Jones, Emma; Wootton, Mandy; Hood, Kerenza; Phillips, Rhiannon; Melbye, Hasse; Llor, Carl; Cals, Jochen; Naik, Gurudutt; Kirby, Nigel; Gal, Micaela; Riga, Evginia; Francis, Nick (Massachusetts Medical Society, 2019-07-11)
    Point-of-care testing of C-reactive protein (CRP) may be a way to reduce unnecessary use of antibiotics without harming patients who have acute exacerbations of chronic obstructive pulmonary disease (COPD). We performed a ...

Browse

DSpace at Cardiff MetCommunities & CollectionsBy issue dateAuthorsTitlesSubjectsThis collectionBy issue dateAuthorsTitlesSubjects

My Account

Login

Statistics

Most Popular ItemsStatistics by CountryMost Popular Authors

DSpace software copyright © 2002-2015  DuraSpace
Contact us | Send feedback | Administrator