The diagnosis of urinary tract infections in young children (DUTY): protocol for a diagnostic and prospective observational study to derive and validate a clinical algorithm for the diagnosis of UTI in children presenting to primary care with an acute illness
- Equal contributors
1 Academic Unit of Primary Health Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK
2 South East Wales Trials Unit (SEWTU), Institute for Translation, Innovation, Methodologies and Engagement, School of Medicine, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XN, UK
3 Wales School of Primary Care Research (WSPCR), Institute of Primary Care & Public Health, School of Medicine, Cardiff University, 5th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XN, UK
4 School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK
5 Department of Primary Care and Public Health Sciences, King’s College London, School of Medicine, 5th Floor Capital House, 42 Weston Street, London, SE1 3QD, UK
6 Department of Primary Medical Care, University of Southampton, Aldermoor Close, Southampton, SO16 5ST, UK
7 Specialist Antimicrobial Chemotherapy Unit, Public Health Wales Microbiology Cardiff, University Hospital Wales, Heath Park, Cardiff, CF14 4XW, UK
8 North Bristol NHS Trust, Southmead Hospital, Westbury-on-Trym, Bristol, BS10 5NB, UK
BMC Infectious Diseases 2012, 12:158 doi:10.1186/1471-2334-12-158Published: 19 July 2012
Urinary tract infection (UTI) is common in children, and may cause serious illness and recurrent symptoms. However, obtaining a urine sample from young children in primary care is challenging and not feasible for large numbers. Evidence regarding the predictive value of symptoms, signs and urinalysis for UTI in young children is urgently needed to help primary care clinicians better identify children who should be investigated for UTI. This paper describes the protocol for the Diagnosis of Urinary Tract infection in Young children (DUTY) study. The overall study aim is to derive and validate a cost-effective clinical algorithm for the diagnosis of UTI in children presenting to primary care acutely unwell.
DUTY is a multicentre, diagnostic and prospective observational study aiming to recruit at least 7,000 children aged before their fifth birthday, being assessed in primary care for any acute, non-traumatic, illness of ≤ 28 days duration. Urine samples will be obtained from eligible consented children, and data collected on medical history and presenting symptoms and signs. Urine samples will be dipstick tested in general practice and sent for microbiological analysis. All children with culture positive urines and a random sample of children with urine culture results in other, non-positive categories will be followed up to record symptom duration and healthcare resource use. A diagnostic algorithm will be constructed and validated and an economic evaluation conducted.
The primary outcome will be a validated diagnostic algorithm using a reference standard of a pure/predominant growth of at least >103, but usually >105 CFU/mL of one, but no more than two uropathogens.
We will use logistic regression to identify the clinical predictors (i.e. demographic, medical history, presenting signs and symptoms and urine dipstick analysis results) most strongly associated with a positive urine culture result. We will then use economic evaluation to compare the cost effectiveness of the candidate prediction rules.
This study will provide novel, clinically important information on the diagnostic features of childhood UTI and the cost effectiveness of a validated prediction rule, to help primary care clinicians improve the efficiency of their diagnostic strategy for UTI in young children.