Point of care urine culture to inform appropriate antibiotic prescribing for uncomplicated urinary tract infection in primary care (POETIC):: a randomised controlled trial of clinical and cost effectiveness

Background: urinary tract infection (UTI) is common and widespread use of antibiotics contributes to antimicrobial resistance. The effectiveness of point of care test (POCT) for urine culture is unknown. Aim /Design: individually randomised trial of the clinical and cost effectiveness of Flexicult™ SSI-Urinary Kit (that identifies and quantifies bacterial growth and antibiotic susceptibility) to guide antibiotic treatment of uncomplicated UTI in adult women in primary care vs. standard care. Methods: multi-level regression compared outcomes between the two groups controlling for clustering. Results: 329 were randomised to POCT and 325 to standard care. Mean age was 47.6, and 90% had two or more of dysuria, frequency and urgency. 82.4% of women randomised to POCT and 88.4% to standard care were prescribed antibiotics at the initial consultation. Clinicians indicated that they had changed management in response to the test result for 190 (63.1%) of 301: 14 (7.4%) were advised not to start taking an antibiotic, 10 (5.3%) were advised to stop taking an antibiotic they had already started, 29 (15.3%) to start taking an antibiotic, 63 (33.2%) to keep taking an antibiotic that was prescribed at the baseline visit, and 74 (38.9%) were prescribed a new antibiotic. Despite this, there was no significant difference in antibiotic use that was concordant with laboratory culture results (primary outcome) at day 3 (39.3% POCT culture vs. 44.1% standard care, OR 0.84, 95% CI 0.58 to 1.20), and there was no evidence of any differences in recovery, patient enablement, UTI recurrences, re-consultation and hospitalisations at follow up. POCT culture was not cost-effective. Conclusions: point of care urine culture marginally reduced initial antibiotic prescribing and resulted in changed management for two thirds of women, but it did not achieve more concordant antibiotic use overall or improve patient reported outcomes including patient enablement, and therefore was neither clinically nor cost effective when used mainly to adjust immediate antibiotic prescriptions. Further research should explore approaches to encourage use of the test to guide initiation of ‘delayed antibiotics’.

[1]  K. Hood,et al.  Clinicians’ interpretations of point of care urine culture versus laboratory culture results: analysis from the four-country POETIC trial of diagnosis of uncomplicated urinary tract infection in primary care , 2017, Family practice.

[2]  V. Siersma,et al.  Clinical accuracy of point-of-care urine culture in general practice , 2017, Scandinavian journal of primary health care.

[3]  H. Goossens,et al.  Cost effectiveness of amoxicillin for lower respiratory tract infections in primary care: an economic evaluation accounting for the cost of antimicrobial resistance. , 2016, The British journal of general practice : the journal of the Royal College of General Practitioners.

[4]  C. Butler,et al.  Incidence, severity, help seeking, and management of uncomplicated urinary tract infection: a population-based survey. , 2015, The British journal of general practice : the journal of the Royal College of General Practitioners.

[5]  H. Goossens,et al.  Analytic laboratory performance of a point of care urine culture kit for diagnosis and antibiotic susceptibility testing , 2015, European Journal of Clinical Microbiology & Infectious Diseases.

[6]  K. Hood,et al.  Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT™ informed management of uncomplicated UTI in primary care , 2014, BMC Family Practice.

[7]  S. Holm,et al.  Mecillinam resistance and outcome of pivmecillinam treatment in uncomplicated lower urinary tract infection in women , 2014, APMIS : acta pathologica, microbiologica, et immunologica Scandinavica.

[8]  M. Wilcox Assuring the quality of diagnostic tests , 2013, BMJ : British Medical Journal.

[9]  H. Harrabi Uncomplicated urinary tract infection. , 2012, The New England journal of medicine.

[10]  T. Hooton Clinical practice. Uncomplicated urinary tract infection. , 2012, The New England journal of medicine.

[11]  Richard Grieve,et al.  Developing Appropriate Methods for Cost-Effectiveness Analysis of Cluster Randomized Trials , 2012, Medical decision making : an international journal of the Society for Medical Decision Making.

[12]  P. Bossuyt,et al.  Assessing the value of diagnostic tests: a framework for designing and evaluating trials , 2012, BMJ : British Medical Journal.

[13]  P. Little,et al.  Validating the prediction of lower urinary tract infection in primary care: sensitivity and specificity of urinary dipsticks and clinical scores in women. , 2010, The British journal of general practice : the journal of the Royal College of General Practitioners.

[14]  Alastair D Hay,et al.  Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis , 2010, BMJ : British Medical Journal.

[15]  P. Little,et al.  Presentation, pattern, and natural course of severe symptoms, and role of antibiotics and antibiotic resistance among patients presenting with suspected uncomplicated urinary tract infection in primary care: observational study , 2010, BMJ : British Medical Journal.

[16]  Johannes B. Reitsma,et al.  A review of solutions for diagnostic accuracy studies with an imperfect or missing reference standard. , 2009, Journal of clinical epidemiology.

[17]  H. Goossens,et al.  Variation in antibiotic prescribing and its impact on recovery in patients with acute cough in primary care: prospective study in 13 countries , 2009, BMJ : British Medical Journal.

[18]  F. Dunstan,et al.  The additional costs of antibiotics and re-consultations for antibiotic-resistant Escherichia coli urinary tract infections managed in general practice. , 2009, International journal of antimicrobial agents.

[19]  L. van Dijk,et al.  Antibiotics for respiratory, ear and urinary tract disorders and consistency among GPs. , 2008, The Journal of antimicrobial chemotherapy.

[20]  Brendan Mason,et al.  Containing antibiotic resistance: decreased antibiotic-resistant coliform urinary tract infections with reduction in antibiotic prescribing by general practices. , 2007, The British journal of general practice : the journal of the Royal College of General Practitioners.

[21]  K. Hood,et al.  An observational study of empirical antibiotics for adult women with uncomplicated UTI in general practice. , 2007, The Journal of antimicrobial chemotherapy.

[22]  Andrew Briggs,et al.  Cost-effectiveness acceptability curves--facts, fallacies and frequently asked questions. , 2004, Health economics.

[23]  T. Fahey,et al.  Clinical management of urinary tract infection in women: a prospective cohort study. , 2003, Family practice.

[24]  J. De Maeseneer,et al.  Randomised controlled trial of nitrofurantoin versus placebo in the treatment of uncomplicated urinary tract infection in adult women. , 2002, The British journal of general practice : the journal of the Royal College of General Practitioners.

[25]  N. Frimodt-Møller,et al.  Validation of FLEXICULT™ SSI-Urinary Kit For Use in the Primary Health Care Setting , 2002, Scandinavian journal of infectious diseases.

[26]  P. Yagupsky,et al.  Clinical Evaluation of a Novel Chromogenic Agar Dipslide for Diagnosis of Urinary Tract Infections , 2000, European Journal of Clinical Microbiology and Infectious Diseases.

[27]  D. Heaney,et al.  A comparison of a Patient Enablement Instrument (PEI) against two established satisfaction scales as an outcome measure of primary care consultations. , 1998, Family practice.

[28]  I. Nazareth,et al.  Decision making by general practitioners in diagnosis and management of lower urinary tract symptoms in women. , 1993, BMJ.

[29]  A. Bergman Urinary tract infections in women , 1991, Current opinion in obstetrics & gynecology.

[30]  Sverre Sandberg,et al.  From biomarkers to medical tests: the changing landscape of test evaluation. , 2014, Clinica chimica acta; international journal of clinical chemistry.

[31]  Andrew St John,et al.  Economic Evidence and Point-of-Care Testing. , 2013, The Clinical biochemist. Reviews.

[32]  L. Burman,et al.  Uricult and Sensicult dipslides for diagnosis of bacteriuria and prediction of drug resistance in primary health care. , 1989, Scandinavian journal of primary health care.