TY - JOUR
T1 - The diagnosis of urinary tract infections in young children (DUTY)
T2 - 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
AU - Downing, Harriet
AU - Thomas-Jones, Emma
AU - Gal, Micaela
AU - Waldron, Cherry Ann
AU - Sterne, Jonathan
AU - Hollingworth, William
AU - Hood, Kerenza
AU - Delaney, Brendan
AU - Little, Paul
AU - Howe, Robin
AU - Wootton, Mandy
AU - Macgowan, Alastair
AU - Butler, Christopher C.
AU - Hay, Alastair D.
AU - Birnie, Kate
AU - Harman, Kim
AU - Peters, Marilyn
AU - Martinson, Kate
AU - Lisles, Catherine
AU - Pickles, Timothy
AU - Lawton, Michael
AU - Benger, Jonathan
AU - Busby, John
AU - Fletcher, Margaret
AU - Dudley, Jan
AU - van der Voort, Judith
AU - O'Brien, Kathryn
AU - Whiting, Penny
AU - Derrick, Catherine
AU - Beech, Steven
AU - Thomas, Elizabeth
AU - Roberts, Victoria
AU - Darmanin, Lewis
AU - Durbaba, Stevo
AU - Hague, Margaret
AU - George, Susan
AU - Wade, Teresa
AU - Sadoo, Annie
AU - Brindle, Peter
AU - Carver, Lisa
PY - 2012/7/19
Y1 - 2012/7/19
N2 - Background: 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.Methods/design: 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.Discussion: 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.
AB - Background: 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.Methods/design: 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.Discussion: 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.
KW - Children
KW - Diagnosis
KW - Dipstick test
KW - Economic models
KW - Near-patient testing
KW - Point-of-care-test
KW - Primary care
KW - Urinary Tract Infection
UR - http://www.scopus.com/inward/record.url?scp=84874013141&partnerID=8YFLogxK
U2 - 10.1186/1471-2334-12-158
DO - 10.1186/1471-2334-12-158
M3 - Article
C2 - 22812651
AN - SCOPUS:84874013141
SN - 1471-2334
VL - 12
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
M1 - 158
ER -
