Surveillance report Published: 7 July 2016 nice.org.uk. NICE All rights reserved.

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2 Contents Surveillance decision... 3 Reason for the decision... 3 Commentary on selected new evidence... 5 Diagnosis diagnostic accuracy of dipstick urinalyses... 5 Diagnosis effectiveness of dipstick testing for UTI... 7 How we made the decision New evidence Views of topic experts Views of stakeholders NICE Surveillance programme project team NICE All rights reserved. Page 2 of 11

3 Surveillance decision We will plan an update of: Diagnosis urine testing. Reason for the decision We found 133 new studies through surveillance of this guideline. New evidence that could affect recommendations was identified. Topic experts, including those who helped to develop the guideline, advised us about whether the following sections of the guideline should be updated: Diagnosis In infants and children with suspected urinary tract infection (UTI), which is the most diagnostically accurate urine test for detecting UTI? From the surveillance review 5 studies were identified evaluating the diagnostic accuracy of urine dipstick testing. Currently, the recommendations specify that patients should be offered microscopy and culture who: are aged less than 3 months to 3 years and present with signs and symptoms of UTI. The recommendations specify the use of urine dipstick testing in children aged 3 years and over. The new evidence suggests that the accuracy of urine dipstick tests is equivalent to that of microscopy in younger children and infants (for example children aged less than 3 months to 3 years old), although this was from catheter or suprapubic urine samples in a hospital setting. The topic experts pointed out that microscopy may be used as a confirmatory test after using a dipstick in younger children, although this may introduce false positives due to contamination as well as detecting more true positives. A urine culture provides additional information about antibiotic sensitivity. The topic experts noted that evidence available during the development of the original guideline, did not take into account diptstick testing in younger infants and therefore this area should be included in an update of this question. Decision: This review question should be updated, specifically for the separate age groups 3 months to 3 years and < 3 months, with consideration of the setting of testing and feasibility of the tests. NICE All rights reserved. Page 3 of 11

4 Other clinical areas We also found new evidence that was not thought to have an effect on current recommendations. This evidence related to signs and symptoms; urine collection; laboratory tests for localising UTI; antibiotic treatment; prevention of recurrence; antibiotic prophylaxis, imaging tests; surgical intervention for vesicoureteric reflux (VUR); indications for follow-up and, information and advice to children, young people and parents/carers. We did not find any new evidence related to urine preservation; indication for culture; history and examination on confirmed UTI; clinical differentiation between acute pyelonephritis/upper UTI and cystitis/lower UTI; and imaging tests for localising UTI; risk of future renal-related morbidity; changing antibiotic prophylaxis. Overall decision After considering all the new evidence and views of topic experts, we decided that a partial update is necessary for this guideline. See how we made the decision for further information. NICE All rights reserved. Page 4 of 11

5 Commentary on selected new evidence With advice from topic experts we selected 2 studies for further commentary. Diagnosis diagnostic accuracy of dipstick urinalyses We selected the prospective observational study by Kanegaye et al. (2014) for a full commentary because it suggests that leukocyte esterase or positive nitrate dipstick test can be used in children aged less than 3 years. This study also provides information for one of the research recommendations from the guideline: "RR-01 Further investigation of leukocyte esterase and nitrite dipstick tests alone and in combination, stratified by age and method of urine collection, is required to determine their accuracy in diagnosing UTI." What the guideline recommends recommends using urgent microscopy and culture in infants younger than 3 months; and infants and children aged 3 months or older but younger than 3 years, with specific or non-specific urinary symptoms. Methods Kanegaye et al. (2014) conducted a prospective observational study using a convenience sample of 342 children aged < 48 months in a single centre study in California. Children were included if they presented to the emergency department (ED) with fever 38 C or had fevers at home within 24 hours, who had urethral catheterisation for point of care dipstick, automated urinanalysis and urine cultures. The study excluded children where there was incomplete data or tests, who had received systemic antibiotics within 24 hours previously, were immunocompromised or at risk of neutropenia. Dipstick and automated microscopy test results were compared to the reference standard of a urine culture reporting a value of > 50,000 CFU/ml as a positive test. Results The study conducted a ROC analysis to show urinary white blood cells (WBC) had an area under the curve (AUC) of 0.97, 95% confidence interval [CI] 0.95 to 0.99; urinary bacteria had AUC of 0.998, 95% CI to 0.999, dipstick leukocyte esterase had AUC of 0.94, 95% CI 0.89 to and dipstick nitrite had AUC of 0.76, 95% CI 0.66 to The study showed that dipstick testing by staff at the point of care agreed with laboratory analysis in 98.5% of nitrite and 98.0% of leukocyte esterase determinations. NICE All rights reserved. Page 5 of 11

6 The study presented the sensitivity, specificity, positive likelihood ratio and negative likelihood ratio for different thresholds of dipstick and laboratory tests. The study showed dipstick testing with a threshold of positive nitrite or 1+ leukocyte esterase had a sensitivity of 0.95, a specificity of 0.98, a positive likelihood ratio of 57.1 and a negative likelihood ratio of 0.05; automated bacterial counts with a threshold of 250 cells/microlitre had a specificity of 0.98, sensitivity of 0.98, a positive likelihood ratio of 48.8 and a negative likelihood ratio of 0.02; automated white blood cell counts with a threshold of 100 cells/microlitre had a sensitivity of 0.86, a specificity of 0.98, a positive likelihood ratio of 42.9 and a negative likelihood ratio of The study concluded that dipstick testing of nitrates and leukocyte esterase was an acceptable diagnostic test diagnosing UTI in infants. Strengths and limitations Strengths The study is prospective in design. The study included children aged <48 months old, a population considered by NICE guideline CG54, but where there is a lack of evidence. Limitations The authors reported that they did not measure interrater reliability of dipstick testing, although the results were checked in the laboratory. No evidence of adjusting for confounders or selection biases. The study did not include the planned number of children of 375 and was therefore underpowered. The study used automated microscopy, which may not be readily available in smaller units. Impact on guideline The new evidence suggests that leukocyte esterase or nitrite positive dipsticks can be useful in the diagnosis of UTI in febrile infants aged < 48 months. This may impact the current recommendations in. NICE All rights reserved. Page 6 of 11

7 Diagnosis effectiveness of dipstick testing for UTI We selected the retrospective observational study Glissmeyer et al. (2014) for a full commentary because the topic experts believed that this study in conjunction with Kanegaye et al. (2014), suggest the use of dipstick testing in febrile infants. This study also provides information for one of the research recommendations from the guideline: "RR-01 Further investigation of leukocyte esterase and nitrite dipstick tests alone and in combination, stratified by age and method of urine collection, is required to determine their accuracy in diagnosing UTI." What the guideline recommends recommends testing the urine of infants in whom UTI is suspected. In this age group, the symptoms and signs are often very non-specific and so the strategy in this study will overlap considerably with infants being tested according to the guideline. Methods An observational study by Glissmeyer et al. (2014) compared the diagnostic use of urine dipsticks alone with urine microscopy and with both tests combined as a test for UTI in 6,394 febrile infants aged 1 to 90 days. The reference standard was urine culture. Due to differences in practice, infants aged 1 to 90 days were subdivided into those aged 1 to 28 days and those aged 29 to 90 days. The study included children who had catheterised urine sample dipstick, microscopic urinalysis, and urine bacterial cultures performed simultaneously. The study excluded children who had urine collection by bag specimen or suprapubic aspirate. The study used medical records to assess the outcome of included children aged 29 to 90 days with UTI not identified by urine dipstick. Results The study showed combined urinalysis had a higher sensitivity for UTI compared to dipstick (94.7%, 95% confidence interval [CI] 94.4% to 95.0% compared to 90.8%, 95% CI 90.4% to 91.2% p < 0.001). The study showed dipstick test compared to combined urinalysis had a higher specificity (93.8%, 95% CI 93.5% to 94.1% compared to 87.6%, 95% CI 87.2% to 88.0%, P< 0.001). Dipstick testing also had a greater positive predictive value (PPV) compared to combined urinalysis (66.8%, 95% CI 66.2% to 67.4% compared to 51.2%, 95% CI 50.6% to 51.8%, p <0.001). NICE All rights reserved. Page 7 of 11

8 Dipstick test compared to microscopic urinalysis had a higher specificity (93.8%, 95% CI 93.5% to 94.1% compared to 91.3%, 95% CI 90.9% to 91.7%, P< 0.00). Dipstick testing also had a greater PPV compared to microscopic urinalysis (66.8%, 95% CI 66.2% to 67.4% compared to 58.6%, 95% CI 58.0% to 59.2%, p <0.001). Dipstick testing had a greater sensitivity (but not significantly greater) to microscopic urinalysis (90.8%, 95% CI 90.4% to 91.2% compared to 90.3%, 95% CI 89.9% to 90.7%, p = 0.157). The negative predictive value (NPV) was greater than 98% for dipstick, combined urinalysis and microscopic urinalysis. A subgroup analysis by age showed in infants aged 1 to 28 days, there was no difference between combined urinalysis and dipstick for NPV. However in infants aged 29 to 90 days old combined urinalysis had a higher NPV compared to dipstick. The study compared the results between the two age groups to show urinalysis tests had a higher specificity and NPV in infants aged 29 to 90 days compared to infants aged 1 to 28 days. Dipstick tests had a higher sensitivity in infants aged 1 to 28 days compared with infants aged 29 to 90 days. The study reported there was no difference in NPV between the two age groups. Strengths and limitations Strengths A large study population. Full results are reported. Limitations No evidence of adjusting for confounders or selection biases. The topic experts felt the age of those included in the study was very narrow age band of patients, and study only applies to secondary care. However, patients of this age are more likely to be referred to secondary care, than managed in primary care. The authors report that the study may be limited by lack of chart review of all participants, which prevented an analysis of urinalysis test performance by clinical appearance. NICE All rights reserved. Page 8 of 11

9 Impact on guideline The new evidence suggests that dipsticks can be used alone or in combination with microscopy in diagnosing UTI in febrile infants aged < 3 months. This may impact on as currently there are no recommendations on testing solely on the basis of presence of a fever in. NICE All rights reserved. Page 9 of 11

10 How we made the decision We check our guidelines regularly to ensure they remain up to date. We based the decision on surveillance 8 years after the publication of urinary tract infection in under 16s (2007) NICE guideline CG54. For details of the process and update decisions that are available, see ensuring that published guidelines are current and accurate in 'Developing NICE guidelines: the manual'. Previous surveillance update decisions for the guideline are on our website. New evidence We found 12 new studies in a search for randomised controlled trials and systematic reviews published between 2 August 2013 and 2 December We also considered 8 additional studies identified by members of the Guideline Committee who originally worked on this guideline. Evidence identified in previous surveillance 3 years after publication of the guideline was also considered. This included 113 studies identified by search. From all sources, 133 studies were considered to be relevant to the guideline. We also checked for relevant ongoing research, which will be evaluated again at the next surveillance review of the guideline. See appendix A: decision matrix for summaries and references for all new evidence considered. Views of topic experts We considered the views of topic experts, including those who helped to develop the guideline. This included a meeting with experts to discuss potential areas for update. Views of stakeholders Stakeholders are consulted only if we decide not to update the guideline following checks at 4 and 8 years after publication. Because this was an 8-year surveillance review, and the decision was to update, we did not consult on the decision. NICE All rights reserved. Page 10 of 11

11 See ensuring that published guidelines are current and accurate in 'Developing NICE guidelines: the manual' for more details on our consultation processes. NICE Surveillance programme project team Sarah ah Willett Associate Director Philip Alderson Consultant Clinical Adviser Katrina Sparrow Technical Adviser Francesca Fasesin Technical Analyst The NICE project team would like to thank the topic experts who participated in the surveillance process. NICE All rights reserved. Page 11 of 11

Surveillance report Published: 17 March 2016 nice.org.uk

Surveillance report 2016 Ovarian Cancer (2011) NICE guideline CG122 Surveillance report Published: 17 March 2016 nice.org.uk NICE 2016. All rights reserved. Contents Surveillance decision... 3 Reason for