Christopher C Butler1, David Gillespie1, Patrick White1, Janine Bates1, Rachel Lowe1, Emma Thomas-Jones1, Mandy Wootton1, Kerenza Hood1, Rhiannon Phillips1, Hasse Melbye1, Carl Llor1, Jochen W L Cals1, Gurudutt Naik1, Nigel Kirby1, Micaela Gal1, Evgenia Riga1, Nick A Francis1. 1. From the Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford (C.C.B., E.R.), the Centre for Trials Research (D.G., J.B., R.L., E.T.-J., K.H., N.K.), the Division of Population Medicine (R.P., G.N., N.A.F.), and Wales Centre for Primary and Emergency Research, School of Medicine (M.G.), Cardiff University, the Specialist Antimicrobial Chemotherapy Unit, Public Health Wales, University Hospital of Wales (M.W.), Cardiff, and the School of Population Health and Environment Science, King's College, London (P.W.) - all in the United Kingdom; the General Practice Research Unit, Department of Community Medicine, University of Tromsø-the Arctic University of Norway, Tromsø, Norway (H.M.); the University Institute in Primary Care Research Jordi Gol, Via Roma Health Center, Barcelona (C.L.); and the Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands (J.W.L.C.).
Abstract
BACKGROUND: 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). METHODS: We performed a multicenter, open-label, randomized, controlled trial involving patients with a diagnosis of COPD in their primary care clinical record who consulted a clinician at 1 of 86 general medical practices in England and Wales for an acute exacerbation of COPD. The patients were assigned to receive usual care guided by CRP point-of-care testing (CRP-guided group) or usual care alone (usual-care group). The primary outcomes were patient-reported use of antibiotics for acute exacerbations of COPD within 4 weeks after randomization (to show superiority) and COPD-related health status at 2 weeks after randomization, as measured by the Clinical COPD Questionnaire, a 10-item scale with scores ranging from 0 (very good COPD health status) to 6 (extremely poor COPD health status) (to show noninferiority). RESULTS: A total of 653 patients underwent randomization. Fewer patients in the CRP-guided group reported antibiotic use than in the usual-care group (57.0% vs. 77.4%; adjusted odds ratio, 0.31; 95% confidence interval [CI], 0.20 to 0.47). The adjusted mean difference in the total score on the Clinical COPD Questionnaire at 2 weeks was -0.19 points (two-sided 90% CI, -0.33 to -0.05) in favor of the CRP-guided group. The antibiotic prescribing decisions made by clinicians at the initial consultation were ascertained for all but 1 patient, and antibiotic prescriptions issued over the first 4 weeks of follow-up were ascertained for 96.9% of the patients. A lower percentage of patients in the CRP-guided group than in the usual-care group received an antibiotic prescription at the initial consultation (47.7% vs. 69.7%, for a difference of 22.0 percentage points; adjusted odds ratio, 0.31; 95% CI, 0.21 to 0.45) and during the first 4 weeks of follow-up (59.1% vs. 79.7%, for a difference of 20.6 percentage points; adjusted odds ratio, 0.30; 95% CI, 0.20 to 0.46). Two patients in the usual-care group died within 4 weeks after randomization from causes considered by the investigators to be unrelated to trial participation. CONCLUSIONS:CRP-guided prescribing of antibiotics for exacerbations of COPD in primary care clinics resulted in a lower percentage of patients who reported antibiotic use and who received antibiotic prescriptions from clinicians, with no evidence of harm. (Funded by the National Institute for Health Research Health Technology Assessment Program; PACE Current Controlled Trials number, ISRCTN24346473.).
RCT Entities:
BACKGROUND: 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). METHODS: We performed a multicenter, open-label, randomized, controlled trial involving patients with a diagnosis of COPD in their primary care clinical record who consulted a clinician at 1 of 86 general medical practices in England and Wales for an acute exacerbation of COPD. The patients were assigned to receive usual care guided by CRP point-of-care testing (CRP-guided group) or usual care alone (usual-care group). The primary outcomes were patient-reported use of antibiotics for acute exacerbations of COPD within 4 weeks after randomization (to show superiority) and COPD-related health status at 2 weeks after randomization, as measured by the Clinical COPD Questionnaire, a 10-item scale with scores ranging from 0 (very good COPD health status) to 6 (extremely poor COPD health status) (to show noninferiority). RESULTS: A total of 653 patients underwent randomization. Fewer patients in the CRP-guided group reported antibiotic use than in the usual-care group (57.0% vs. 77.4%; adjusted odds ratio, 0.31; 95% confidence interval [CI], 0.20 to 0.47). The adjusted mean difference in the total score on the Clinical COPD Questionnaire at 2 weeks was -0.19 points (two-sided 90% CI, -0.33 to -0.05) in favor of the CRP-guided group. The antibiotic prescribing decisions made by clinicians at the initial consultation were ascertained for all but 1 patient, and antibiotic prescriptions issued over the first 4 weeks of follow-up were ascertained for 96.9% of the patients. A lower percentage of patients in the CRP-guided group than in the usual-care group received an antibiotic prescription at the initial consultation (47.7% vs. 69.7%, for a difference of 22.0 percentage points; adjusted odds ratio, 0.31; 95% CI, 0.21 to 0.45) and during the first 4 weeks of follow-up (59.1% vs. 79.7%, for a difference of 20.6 percentage points; adjusted odds ratio, 0.30; 95% CI, 0.20 to 0.46). Two patients in the usual-care group died within 4 weeks after randomization from causes considered by the investigators to be unrelated to trial participation. CONCLUSIONS:CRP-guided prescribing of antibiotics for exacerbations of COPD in primary care clinics resulted in a lower percentage of patients who reported antibiotic use and who received antibiotic prescriptions from clinicians, with no evidence of harm. (Funded by the National Institute for Health Research Health Technology Assessment Program; PACE Current Controlled Trials number, ISRCTN24346473.).
Authors: David Gillespie; Christopher C Butler; Janine Bates; Kerenza Hood; Hasse Melbye; Rhiannon Phillips; Helen Stanton; Mohammed Fasihul Alam; Jochen Wl Cals; Ann Cochrane; Nigel Kirby; Carl Llor; Rachel Lowe; Gurudutt Naik; Evgenia Riga; Bernadette Sewell; Emma Thomas-Jones; Patrick White; Nick A Francis Journal: Br J Gen Pract Date: 2021-03-26 Impact factor: 5.386
Authors: Andrew I Ritchie; Simon E Brill; Ben H Vlies; Lydia J Finney; James P Allinson; Luana Alves-Moreira; Dexter J Wiseman; Paul P Walker; Emma Baker; Sarah L Elkin; Patrick Mallia; Martin Law; Gavin C Donaldson; Peter M A Calverley; Jadwiga A Wedzicha Journal: Am J Respir Crit Care Med Date: 2020-08-15 Impact factor: 21.405
Authors: Nick A Francis; David Gillespie; Patrick White; Janine Bates; Rachel Lowe; Bernadette Sewell; Rhiannon Phillips; Helen Stanton; Nigel Kirby; Mandy Wootton; Emma Thomas-Jones; Kerenza Hood; Carl Llor; Jochen Cals; Hasse Melbye; Gurudutt Naik; Micaela Gal; Deborah Fitzsimmons; Mohammed Fasihul Alam; Evgenia Riga; Ann Cochrane; Christopher C Butler Journal: Health Technol Assess Date: 2020-03 Impact factor: 4.014
Authors: Mihaela S Stefan; Kerry A Spitzer; Sehar Zulfiqar; Brent D Heineman; Timothy P Hogan; Lauren M Westafer; Michael S Pulia; Victor M Pinto-Plata; Peter K Lindenauer Journal: J Asthma Date: 2020-11-19 Impact factor: 2.515