Abstract
BackgroundUrinary 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.Methods/designDUTY 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.DiscussionThis 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.
Highlights
Urinary tract infection (UTI) is common in children, and may cause serious illness and recurrent symptoms
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
The clinical diagnosis of UTI in young children is difficult because: (1) pre-verbal children cannot articulate symptoms and present with the same nonspecific symptoms when suffering from a wide range of illnesses [6]; (2) identifying dysuria and changes in urination frequency in children wearing nappies is difficult; (3) obtaining urine samples is often challenging and time consuming for parents[1] and costly to the health service [7,8]; and (4) the National Institute for Health and Clinical Excellence (NICE) does not recommend routine urine dipstick testing in children under 3 years because of a lack of research evidence as to its diagnostic value [9]
Summary
This paper describes a diagnostic and prospective observational study in primary care, that aims to recruit at least 7,000 children aged before their fifth birthday, who are assessed for any acute, non traumatic, illness of ≤ 28 days duration. In addition the follow-up data at 14 days and 3 months will allow for full health economic analysis, providing cost effectiveness outcomes Additional useful information such as the best way of sampling urine from young children in primary care, the species and sensitivities of the infecting organisms, and contamination rates will inform care in the future. A challenge will be to ensure all data is entered into the database in a timely way, to allow for both the real time monitoring of recruitment and urine sample location, as well as the conduction of the follow-up interviews within the tight timeframe This will be one of the largest studies of its kind undertaken in primary care, involving obtaining clinical samples from children, and will help guide management of the acutely unwell child, which is a common and important aspect of primary health care delivery. All authors listed provided critical review and final approval of the manuscript
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