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

Downing, Harriet; Thomas-Jones, Emma; Gal, Micaela; Waldron, Cherry-Ann; Sterne, Jonathan A C; Hollingworth, William; Hood, Kerenza; Delaney, Brendan; Little, Paul; Howe, Robin; Wootton, Mandy; MacGowan, Alasdair; Butler, Christopher Collett

doi:10.1186/1471-2334-12-158

Cited by 30 publications

(34 citation statements)

References 34 publications

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“…105 For a full description of the measures taken to minimise contamination of urine specimens, see Chapter 2.…”

Section: Participants Urine Collection and Microbiological Methodsmentioning

confidence: 99%

“…The outcomes of the first four objectives are reported in this publication but the fifth was changed prior to publication of the final protocol 105 (see Appendix 3). This was because the study eligibility criteria meant all children were unwell (or had urinary symptoms) thus making it difficult to determine asymptomatic bacteriuria as no children were asymptomatic.…”

Section: Planned Change To Research Objectivementioning

confidence: 99%

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The Diagnosis of Urinary Tract infection in Young children (DUTY): a diagnostic prospective observational study to derive and validate a clinical algorithm for the diagnosis of urinary tract infection in children presenting to primary care with an acute illness

Hay

Birnie²,

Busby³

et al. 2016

Health Technol Assess

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BackgroundIt is not clear which young children presenting acutely unwell to primary care should be investigated for urinary tract infection (UTI) and whether or not dipstick testing should be used to inform antibiotic treatment.ObjectivesTo develop algorithms to accurately identify pre-school children in whom urine should be obtained; assess whether or not dipstick urinalysis provides additional diagnostic information; and model algorithm cost-effectiveness.DesignMulticentre, prospective diagnostic cohort study.Setting and participantsChildren < 5 years old presenting to primary care with an acute illness and/or new urinary symptoms.MethodsOne hundred and seven clinical characteristics (index tests) were recorded from the child’s past medical history, symptoms, physical examination signs and urine dipstick test. Prior to dipstick results clinician opinion of UTI likelihood (‘clinical diagnosis’) and urine sampling and treatment intentions (‘clinical judgement’) were recorded. All index tests were measured blind to the reference standard, defined as a pure or predominant uropathogen cultured at ≥ 105colony-forming units (CFU)/ml in a single research laboratory. Urine was collected by clean catch (preferred) or nappy pad. Index tests were sequentially evaluated in two groups, stratified by urine collection method: parent-reported symptoms with clinician-reported signs, and urine dipstick results. Diagnostic accuracy was quantified using area under receiver operating characteristic curve (AUROC) with 95% confidence interval (CI) and bootstrap-validated AUROC, and compared with the ‘clinician diagnosis’ AUROC. Decision-analytic models were used to identify optimal urine sampling strategy compared with ‘clinical judgement’.ResultsA total of 7163 children were recruited, of whom 50% were female and 49% were < 2 years old. Culture results were available for 5017 (70%); 2740 children provided clean-catch samples, 94% of whom were ≥ 2 years old, with 2.2% meeting the UTI definition. Among these, ‘clinical diagnosis’ correctly identified 46.6% of positive cultures, with 94.7% specificity and an AUROC of 0.77 (95% CI 0.71 to 0.83). Four symptoms, three signs and three dipstick results were independently associated with UTI with an AUROC (95% CI; bootstrap-validated AUROC) of 0.89 (0.85 to 0.95; validated 0.88) for symptoms and signs, increasing to 0.93 (0.90 to 0.97; validated 0.90) with dipstick results. Nappy pad samples were provided from the other 2277 children, of whom 82% were < 2 years old and 1.3% met the UTI definition. ‘Clinical diagnosis’ correctly identified 13.3% positive cultures, with 98.5% specificity and an AUROC of 0.63 (95% CI 0.53 to 0.72). Four symptoms and two dipstick results were independently associated with UTI, with an AUROC of 0.81 (0.72 to 0.90; validated 0.78) for symptoms, increasing to 0.87 (0.80 to 0.94; validated 0.82) with the dipstick findings. A high specificity threshold for the clean-catch model was more accurate and less costly than, and as effective as, clinical judgement. The additional diagnostic utility of dipstick testing was offset by its costs. The cost-effectiveness of the nappy pad model was not clear-cut.ConclusionsClinicians should prioritise the use of clean-catch sampling as symptoms and signs can cost-effectively improve the identification of UTI in young children where clean catch is possible. Dipstick testing can improve targeting of antibiotic treatment, but at a higher cost than waiting for a laboratory result. Future research is needed to distinguish pathogens from contaminants, assess the impact of the clean-catch algorithm on patient outcomes, and the cost-effectiveness of presumptive versus dipstick versus laboratory-guided antibiotic treatment.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…105 For a full description of the measures taken to minimise contamination of urine specimens, see Chapter 2.…”

Section: Participants Urine Collection and Microbiological Methodsmentioning

confidence: 99%

Section: Planned Change To Research Objectivementioning

confidence: 99%

The Diagnosis of Urinary Tract infection in Young children (DUTY): a diagnostic prospective observational study to derive and validate a clinical algorithm for the diagnosis of urinary tract infection in children presenting to primary care with an acute illness

Hay

Birnie²,

Busby³

et al. 2016

Health Technol Assess

Self Cite

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“…10 In summary, parents were asked to provide consent for their child's participation, after which clinicians recorded the following data using a standardised case report form:…”

Section: Clinical Data Collectionmentioning

confidence: 99%

Childhood urinary tract infection in primary care: a prospective observational study of prevalence, diagnosis, treatment, and recovery

Butler

O’Brien²,

Pickles

et al. 2015

Br J Gen Pract

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“…8 Children were eligible if presenting with any acute (<28 days), undifferentiated illness (even when the clinician was confident of the diagnosis, such as a child with bronchiolitis), and/or new urinary symptoms.…”

Section: Methods Participantsmentioning

confidence: 99%

“…3,8,9 First, the parent was asked to clean the nappy area using water or wipes (the wipes being supplied by the study). A nappy pad was inserted inside a clean nappy, and the nappy refastened.…”

Section: Index Tests and Urine Collectionmentioning

confidence: 99%

Nappy pad urine samples for investigation and treatment of UTI in young children: the ‘DUTY’ prospective diagnostic cohort study

et al. 2016

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Acutely unwell children <5 years presenting to 233 UK primary care sites. MethodLogistic regression to identify independent associations of symptoms, signs, and urine dipstick test results with UTI; diagnostic utility quantified as area under the receiver operator curves (AUROC). Nappy pad rule characteristics, AUROC, and contamination, compared with findings from clean-catch samples. ResultsNappy pad samples were obtained from 3205 children (82% aged <2 years; 48% female), culture results were available for 2277 (71.0%) and 30 (1.3%) had a UTI on culture. Female sex, smelly urine, darker urine, and the absence of nappy rash were independently associated with a UTI, with an internally-validated, coefficient model AUROC of 0.81 (0.87 for clean-catch), which increased to 0.87 (0.90 for clean-catch) with the addition of dipstick results. GPs' 'working diagnosis' had an AUROC 0.63 (95% confidence intervals [CI] = 0.53 to 0.72). A total of 12.2% of nappy pad and 1.8% of cleancatch samples were 'frankly contaminated' (risk ratio 6.66; 95% CI = 4.95 to 8.96; P<0.001). ConclusionNappy pad urine culture results, with features that can be reported by parents and dipstick tests, can be clinically useful, but are less accurate and more often contaminated compared with clean-catch urine culture.

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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

Cited by 30 publications

References 34 publications

The Diagnosis of Urinary Tract infection in Young children (DUTY): a diagnostic prospective observational study to derive and validate a clinical algorithm for the diagnosis of urinary tract infection in children presenting to primary care with an acute illness

The Diagnosis of Urinary Tract infection in Young children (DUTY): a diagnostic prospective observational study to derive and validate a clinical algorithm for the diagnosis of urinary tract infection in children presenting to primary care with an acute illness

Childhood urinary tract infection in primary care: a prospective observational study of prevalence, diagnosis, treatment, and recovery

Nappy pad urine samples for investigation and treatment of UTI in young children: the ‘DUTY’ prospective diagnostic cohort study

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