NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Centre for Clinical Practice Surveillance Programme

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1 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Centre for Clinical Practice Surveillance Programme Clinical guideline CG54: Urinary tract infection: diagnosis, treatment and long-term management of urinary tract infection in children Publication date August 2007 (no update) Previous review date August 2010 Surveillance report for GE September 2013 Key findings Potential impact on guidance Evidence identified from Evidence Update Evidence identified from literature search Feedback from Guideline Development Group Anti-discrimination and equalities considerations No update Rapid update Standard update Yes Transfer to static list No Change review cycle Surveillance recommendation The guideline should be considered for a standard update, pending the publication of the DUTY and RIVUR studies. As these studies are unlikely to be published until late 2014 the surveillance review due in 2015 will be conducted as scheduled to assess whether additional areas would need updating at that time in addition to those identified above. CG54 UTI in children Surveillance Review Decision October of 17

2 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Centre for Clinical Practice Surveillance Programme Surveillance review of CG54: Urinary tract infection: diagnosis, treatment and long-term management of urinary tract infection in children Background information Guideline issue date: year review: 2010 (no update) 6 year review: 2013 NCC: Women s and Children s Health Main conclusions from previous surveillance review 1. CG54 was previously reviewed for update in August No new evidence was identified which would change the direction of guideline recommendations. However, the original Guideline Development Group (GDG) highlighted relevant ongoing studies (DUTY and RIVUR trials) evaluating diagnosis of UTI and long-term antibiotic treatment respectively.the review recommendation at that review point was that the guideline should not be considered for an update. Six year surveillance review 2. The Evidence Update on CG54: Urinary tract infection in children was used as the primary source of evidence for this surveillance review which considered new evidence since the last surveillance review (searches conducted August 2010). An additional literature search for systematic reviews was carried out between April 2013 (the end of the search period for the Evidence Update) and August 2013 and relevant abstracts were assessed. Clinical feedback on the guideline was obtained from five members of the GDG through a questionnaire CG54 UTI in children Surveillance Review Decision October of 17

3 3. New evidence that may impact on recommendations was identified relating to the following two clinical areas within the guideline: Clinical area 1: Diagnosis (urine collection) - recommendation Q: In infants and children with suspected UTI, which method of urine collection is most effective? Evidence summary GDG/clinical perspective Impact Evidence identified from Evidence Update The guideline recommends that catheter samples or suprapubic aspiration (SPA) should be used when it is not possible or practical to collect urine by noninvasive methods. One study relevant to this clinical area was identified in the Evidence Update of CG54 (expected publication date September 2013) which indicated that urine sampling via catheterisation may be associated with a higher success rate, and less pain, than SPA. 1 Feedback from the GDG highlighted one study which indicated that contamination rates were higher in clean catch urine samples compared with suprapubic aspiration and catheter specimen urine which could have an implication on the diagnostic accuracy of the sample. 2 Clinical area 2: Long-term management (imaging tests) - recommendations Q: In infants and children who present with UTI, what proportion have undiagnosed structural renal tract abnormality? Q: In infants and children who have had a UTI, what are the predictors of scarring? Q: In infants and children who have a UTI, what is the risk of (developing) scarring? Q: In infants and children who have had a UTI, what is the most effective test for detecting scarring? Q: In infants and children who have had UTI, what is the most effective test for diagnosing structural abnormality? Q: In infants and children who have had a UTI, what is the most effective test for detecting vesicoureteric reflux? Evidence summary GDG/clinical perspective Impact Evidence identified from Evidence Update New evidence identified for the Evidence Update indicated that the imaging protocol recommended by the guideline may have high In terms of imaging strategies, the GDG highlighted several new studies and indicated that there is an increased awareness of the drawbacks of invasive imaging tests relating to This new evidence may enable a more specific recommendation on invasive urine collection methods to be made whereby catheterisation may be recommended over SPA when invasive methods are required for urine collection. The new evidence may indicate a reduced need for imaging in UTI, particularly in the detection of VUR, which could potentially impact the current recommended imaging strategy. CG54 UTI in children Surveillance Review Decision October of 17

4 specificity but low sensitivity for detecting vesicoureteric reflux (VUR) and scarring and may be associated with more radiation exposure than other diagnostic protocols. 1,3,4 Two studies evaluated the prevalence of VUR among children with and without a UTI, suggesting that prevalence could be as high as one third, and does not appear to differ between children with and without UTI. 5,6 cost, radiation exposure and psychological trauma Furthermore, it was suggested there is doubt in clinical practice that some of the recommended imaging tests make a difference to outcomes particularly when considering the risks of imaging strategies. In particular, there was a view that children should be offered further investigations and management only in response to very severe illness, failure to get better as expected and recurrent UTI or other complications. Ongoing research 4. Feedback from the GDG highlighted two ongoing trials relevant to the guideline: a. The diagnosis of urinary tract infection in young children (DUTY) study is underway with a proposed publication date of The aim of the study is to develop and validate a clinical algorithm for the diagnosis of UTI in children under the age of five. b. The randomised intervention for children with vesicoureteral reflux (RIVUR) trial was also highlighted with a proposed completion date of October The aim of the RIVUR trial is to determine whether all children with vesicoureteral reflux (VUR) should be treated with antibiotics. 5. The results of these trials have not been published at this time therefore it is not possible to determine any potential impact on guideline recommendations. However, data from these trials may contribute towards the evidence base relating to diagnosis of UTI in children under five and antibiotic treatment for VUR in the next surveillance review. Anti-discrimination and equalities considerations 6. None identified. CG54 UTI in children Surveillance Review Decision October of 17

5 Implications for other NICE programmes 7. This guideline relates to a Quality Standard on urinary tract infection in children (QS36). 8. None of the quality statements are likely to be affected by the proposed areas for update. Conclusion 9. Through the surveillance review of CG54, new evidence which may potentially change the direction of guideline recommendations was identified in the following areas: a. Diagnosis: urine collection b. Long-term management: imaging tests 10. For all other areas of the guideline no evidence was identified which would impact on recommendations at this surveillance review point. 11. Two ongoing studies were identified which are likely to have an impact on the guideline recommendations in the future (DUTY and RIVUR studies: expected to be published late 2014). Therefore, the update of this guideline should be deferred until the next surveillance review point (2015) to enable the conclusions of the DUTY and RIVUR studies and any impact on guideline recommendations to be taken into consideration. Surveillance recommendation 12. The guideline should be considered for a standard update, pending the publication of the DUTY and RIVUR studies. As these studies are unlikely to be published until late 2014 the surveillance review due in 2015 will be conducted as scheduled to assess whether additional areas would need updating at that time in addition to those identified above. Mark Baker Centre Director Sarah Willett Associate Director Emma McFarlane Technical Analyst Centre for Clinical Practice October 2013 CG54 UTI in children Surveillance Review Decision October of 17

6 References 1. Finnell SM, Carroll AE, and Downs SM. (2011) Technical report-diagnosis and management of an initial UTI in febrile infants and young children. Pediatrics 128: Tosif S, Baker A, Oakley E et al. (2012) Contamination rates of different urine collection methods for the diagnosis of urinary tract infections in young children: an observational cohort study. J Paediatr Child Health 48: La Scola, De MC, Hewitt IK et al. (2013) Different guidelines for imaging after first UTI in febrile infants: yield, cost, and radiation. Pediatrics 131:e665-e Routh JC, Grant FD, Kokorowski PJ et al. (2012) Economic and radiation costs of initial imaging approaches after a child's first febrile urinary tract infection. Clin Pediatr (Phila.) 51: Hannula A, Venhola M, Renko M et al. (2010) Vesicoureteral reflux in children with suspected and proven urinary tract infection. Pediatr Nephrol 25: Venhola M, Hannula A, Huttunen NP et al. (2010) Occurrence of vesicoureteral reflux in children. Acta Paediatr 99: Berry CS, Vander Brink BA, Koff SA et al. (2012) Is VCUG still indicated following the first episode of urinary tract infection in boys? Urology 80: Pennesi M, L'Erario I, Travan L et al. (2012) Managing children under 36 months of age with febrile urinary tract infection: a new approach. Pediatr Nephrol 27: Printza N, Farmaki E, Piretzi K et al. (2012) Acute phase 99mTc-dimercaptosuccinic acid scan in infants with first episode of febrile urinary tract infection. World J Pediatr 8: Sayedzadeh SA, Malaki M, Shoaran M et al. (2011) Kidney imaging in management of delayed febrile urinary tract infection. Saudi J Kidney Dis.Transpl. 22: Schroeder AR, Abidari JM, Kirpekar R et al. (2011) Impact of a more restrictive approach to urinary tract imaging after febrile urinary tract infection. Arch Pediatr Adolesc Med 165: Spencer JD, Bates CM, Mahan JD et al. (2012) The accuracy and health risks of a voiding cystourethrogram after a febrile urinary tract infection. J Pediatr Urol 8: CG54 UTI in children Surveillance Review Decision October of 17

7 Appendix 1 Decision matrix Surveillance and identification of triggers for updating CG54. The table below provides summaries of the evidence for questions for which studies were identified. Conclusions from previous In infants and children, what are the predisposing factors for a UTI? One study was identified which the Yes defined the association between the frequency of changing diapers and UTI in infants concluding that in infants wearing disposable diapers, there is an increased risk of UTI as the frequency of changing diapers decreases. In infants and children, what signs and symptoms would give rise to the suspicion of UTI? No relevant evidence identified Yes question does not need to be updated. No: a meta-analysis identified through the literature search and a technical report identified for the Evidence Update reported predisposing factors in line with current guideline recommendations. No: a cohort study reported in the Evidence Update found that offensive urine as one of the least common signs and symptoms of UTI which is in line with the guideline. In infants and children with suspected UTI, which method of urine collection is most effective? Through the focused search 10 studies relevant to the clinical question were identified. No Yes Literature was identified evaluating different urine collection methods in Finnell SM, Carroll AE, Downs SM et al (2011). Technical report diagnosis and management of an initial UTI in febrile infants and young children. Pediatrics New evidence is consistent with guideline recommendations. New evidence is consistent with guideline recommendations. One study relevant to this clinical area was identified by the Evidence Update which indicated that urine sampling via catheterisation may be associated with a higher success rate, and less pain, than suprapubic aspiration. This new evidence CG54 UTI in children Surveillance Review Decision October of 17

8 children including urine collection bags, clean catch specimens, urethral catheterisation and suprapubic aspiration. The identified evidence does not change the direction of current guideline recommendations. No new evidence was identified relating to the cost effectiveness of urine collection methods. 128: e Tosif S. Baker A. Oakley E. Donath S. Babl FE (2012). Contamination rates of different urine collection methods for the diagnosis of urinary tract infections in young children: an observational cohort study. Journal of Paediatrics and child health, 48(8): may enable a more specific recommendation on invasive urine collection methods to be made. In addition, one study highlighted by GDG indicated that contamination rates were higher in clean catch urine compared with suprapubic aspiration and catheter specimen urine which could have an implication on the diagnostic accuracy of the sample. How should a urine sample be transported to ensure its reliability? No relevant evidence identified question does not need to be updated. Yes No No relevant evidence identified. In infants and children with suspected UTI, which is the most diagnostically accurate urine test for detecting UTI? In infants and children with suspected UTI, which is the most effective diagnostic test? Through the focused search 12 studies relevant to the clinical questions were identified. Yes No relevant evidence identified. Literature was identified relating to the use of microscopy, culture, dipstick testing and flow cytometry for detection of UTI in children. One metaanalysis was identified which aimed to determine the diagnostic performance of urine dipstick testing in children with suspected UTI compared with microscopy. The study indicated that No: IL-8 was highlighted in the previous review as an area to watch in future reviews. No evidence on IL-8 as a rapid laboratory method for diagnosis of UTI was identified at the 6 year review point. CG54 UTI in children Surveillance Review Decision October of 17

9 urine dipstick testing can be recommended for diagnosis of UTI in children over two years of age however the study reiterated the research recommendation given in the guideline concluding that further studies, stratified by age and comparing urine dipstick testing with microscopy are required. In terms of localisation of UTI using laboratory tests, several studies were identified evaluating C-reactive protein, serum procalcitonin, interleukin-6 and interleukin-8 as biomarkers. It was concluded that further research is needed to evaluate the effectiveness of procalcitonin and other inflammatory markers in localising UTI. In infants and children with suspected UTI, what is the most effective test for assessing localisation of UTI? No relevant evidence identified question does not need to be updated. Yes No: two studies were identified for the Evidence Update evaluating C-reactive protein and procalcitonin as markers for predicting UTI. However, it was concluded that further research in this area is required. In infants and children with UTI, which is the most effective antibiotic treatment? In infants and children with suspected UTI, how does oral antibiotic treatment compare with intravenous antibiotic treatment? New evidence is unlikely to impact on current recommendations. CG54 UTI in children Surveillance Review Decision October of 17

10 Twelve studies were identified through the focused search relating to this clinical question. Yes No No new relevant evidence identified. Literature was identified evaluating antibiotic treatment for UTI. Some studies were identified focusing on short versus long courses of antibiotic therapy however, more conclusive evidence is required to determine the optimal duration of therapy. No new evidence was identified which would warrant an update of the guideline recommendations at this time. In infants and children with UTI, which is the most effective symptomatic treatment in addition to antibiotics? In terms of symptomatic treatment of UTI in children, two RCTs and a systematic review were identified focusing on the clinical effectiveness of cranberry products. The RCTs reported inconsistent results whilst the systematic review was unable to identify good quality evidence focusing on the effectiveness of cranberry juice in treatment of UTIs. As such, no conclusive evidence on the effectiveness of cranberry products was identified. Yes No: one review was identified through the literature search which reviewed the use of cranberry products for treating UTI but no literature was identified in this area. In addition, one Cochrane review was identified by the Evidence Update which found that, compared with control (placebo, water or no treatment), cranberry products did not reduce symptomatic UTI in a subgroup of children with recurrent UTI. The guideline recommends that children New evidence is unlikely to impact on current recommendations. CG54 UTI in children Surveillance Review Decision October of 17

11 who have had a UTI should be encouraged to drink an adequate amount, but no recommendations are made about specific foods or drinks for preventing UTIs therefore, these studies are unlikely to impact on guideline recommendations. In infants and children who have or develop a renal scar, what is the risk of future renal-related morbidity? No relevant evidence identified question does not need to be updated. Yes No No new relevant evidence identified. How should infants and children with recurrent UTI be managed? What strategies other than antibiotics are helpful in preventing recurrence? Two studies were identified, a retrospective case note review and a systematic review. Nothing relevant identified which would impact on guideline recommendations. Yes No No new relevant evidence identified. In infants and children who have had a UTI, how effective is the use of prophylactic antibiotics? In infants and children on prophylaxis, what are the indications for changing antibiotic? Through the focused search 12 studies relevant to the clinical questions were identified. Yes New evidence is unlikely to impact on current recommendations. Literature (including several RCTs) was identified evaluating the efficacy of antibiotic prophylaxis for UTI in children. The RCTs reported varying conclusions whilst systematic reviews No: one review was identified through the literature search which reviewed the use of prophylactic antibiotics in reducing the risk of recurrent UTI. A small reduction in the risk of repeat symptomatic UTI over 12 months of treatment but it was not specified in the abstract if this was a significant reduction. CG54 UTI in children Surveillance Review Decision October of 17

12 concluded that evidence is lacking relating to the efficacy of prophylactic antibiotics for UTI in children. Therefore, the current body of evidence does not seem to be conclusive. As such, no sufficient conclusive new evidence was identified which would warrant an update of the guideline recommendations at this time. In addition, the following studies were identified for the Evidence Update but it was concluded that these studies would not impact on the guideline recommendations: Antibiotic resistance in UTI (one cohort study) Antibiotic prophylaxis in children at risk of recurrent UTI (one Cochrane review) Antibiotic prophylaxis in children with VUR (one Cochrane review and one systematic review) Antibiotic prophylaxis vs. endoscopic injection in VUR (one systematic review) Finally, a new area was highlighted by the Evidence Update - methylprednisolone in the management of acute pyelonephritis. The Evidence Update concluded further research in this area is needed before determining whether there is any impact on guideline recommendations. In infants and children who present with UTI, what proportion have undiagnosed structural renal tract abnormality? In infants and children who have had a UTI, what are the predictors of scarring? In infants and children who have a UTI, what is the risk of (developing) scarring? In infants and children who have or have had UTI, what is the most effective test for diagnosing structural abnormality / vesicoureteric reflux / scarring? Through the focused search 23 studies No Yes New evidence identified for the Evidence CG54 UTI in children Surveillance Review Decision October of 17

13 relevant to the clinical questions were identified. Literature was identified which compared imaging tests including ultrasound, dimercaptosuccinic acid scintigraphy and voiding cystourethrography for diagnosing structural abnormality, renal scarring and vesicoureteral reflux. The identified studies compared different imaging tests and reported inconsistent results and as such, the current body of evidence does not seem conclusive. Few studies were identified which examined the diagnostic accuracy of magnetic resonance imaging (MRI) for UTI. This was a research area identified in the guideline and as such, further research is required to investigate the diagnostic accuracy and cost-effectiveness of MRI as an imaging test for UTI. No sufficient conclusive new evidence was identified which would warrant an update of the guideline recommendations at this time. The following studies were highlighted by the Evidence Update and the GDG: Berry CS, Vander Brink BA, Koff SA, Alpert SA, Jayanthi VR (2012). Is VCUG still indicated following the first episode of urinary tract infection in boys? Urology, 80(6): Finnell SM, Carroll AE, and Downs SM. (2011) Technical report-diagnosis and management of an initial UTI in febrile infants and young children. Pediatrics 128: Hannula A, Venhola M, Renko M et al. (2010) Vesicoureteral reflux in children with suspected and proven urinary tract infection. Pediatr Nephrol 25: La Scola C, De MC, Hewitt IK et al. (2013) Different guidelines for imaging after first UTI in febrile infants: yield, cost, and radiation. Pediatrics 131:e665-e671. Pennesi M, L'erario I, Travan L, Ventura A (2012). Managing children under 36 months of age with febrile urinary tract infection: a new approach. Pediatric Nephrology, 27(4): Printza N, Farmaki E, Piretzi K, Arsos Update indicated that the imaging protocol recommended by the guideline may have high specificity but low sensitivity for detecting VUR and scarring and may be associated with more radiation exposure than other guidelines. Three studies evaluated the prevalence of VUR among children with and without a UTI, suggesting that prevalence could be as high as one third, and does not appear to differ between children with and without UTI. In summary, the new evidence may indicate a reduced need for imaging in UTI, particularly in the detection of VUR, which could potentially impact the current imaging strategy recommended in the guideline. Feedback from the GDG indicated that there is an increased awareness of the drawbacks of invasive imaging tests relating to cost, radiation exposure and psychological trauma. Furthermore, it was suggested there is doubt in clinical practice that some of the recommended imaging tests make a difference to outcomes particularly when considering the risks of imaging strategies. CG54 UTI in children Surveillance Review Decision October of 17

14 G, Kollios K, Papachristou F (2012). Acute phase 99mTcdimercaptosuccinic acid scan in infants with first episode of febrile urinary tract infection. World Journal of Pediatrics, 8(1): Roberts KB (2011). Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics, 128(3): Routh JC, Grant FD, Kokorowski PJ et al. (2012) Economic and radiation costs of initial imaging approaches after a child's first febrile urinary tract infection. Clin Pediatr (Phila.) 51: Sayedzadeh SA. Malaki M. Shoaran M. Nemati M (2011). Kidney imaging in management of delayed febrile urinary tract infection. Saudi Journal of Kidney Diseases 22(6): Schroeder AR. Abidari JM. Kirpekar R. Hamilton JR. Kang YS. Tran V. Harris SJ (2011). Impact of a more restrictive approach to urinary tract imaging after febrile urinary tract infection. Archives of Pediatrics CG54 UTI in children Surveillance Review Decision October of 17

15 165(11): Spencer JD, Bates CM, Mahan JD, Niland ML, Staker SR, Hains DS, Schwaderer AL (2012). The accuracy and health risks of a voiding cystourethrogram after a febrile urinary tract infection. Journal of pediatric urology, 8(1): Venhola M, Hannula A, Huttunen NP et al. (2010) Occurrence of vesicoureteral reflux in children. Acta Paediatr 99: The following studies were highlighted by the Evidence Update but are unlikely to impact on the guideline recommendations: Cohort study indicating that UTIs caused by Enterococcus spp. need to be managed appropriately due to the risk of more abnormalities Cohort study and a technical report evaluating ultrasound alone for imaging of urinary tract Cohort study assessing incidence of abnormal imaging after UTI in patients whose kidneys appeared normal on prenatal ultrasound. More research required in this area CG54 UTI in children Surveillance Review Decision October of 17

16 Meta-analysis evaluating accuracy of DMSA to identify vesicoureteric reflux Finally, one review was identified through the literature search which is unlikely to have an impact on the guideline. This review evaluated validity of prenatal ultrasound as a top-down approach to investigate febrile UTI but further research directly assessing the diagnostic value of prenatal ultrasound to investigate febrile UTI is required before considering this strategy in the guideline. How does surgical management of VUR compare with conservative management? Through the focused search 8 studies Yes relevant to the clinical question were identified. Several RCTs were identified comparing antibiotic prophylaxis, endoscopic treatment or surveillance as the control group in children with grade III or IV vesicoureteral reflux. No new evidence was identified which would warrant an update of the guideline recommendations at this time. No: the results of one Cochrane review indicated that the added benefit of surgical or endoscopic correction of VUR over antibiotic treatment alone remains unclear, therefore this evidence is unlikely to have an impact on the guideline. New evidence is unlikely to impact on current recommendations. CG54 UTI in children Surveillance Review Decision October of 17

17 What are the indications for follow-up? What follow-up assessments are required for children with damaged kidneys? No relevant evidence identified question does not need to be updated. Yes No: the Evidence Update identified a cohort study and a systematic review which indicated that the risk of long-term complications after UTI in childhood appear to be low. These data are consistent with the guideline. New evidence is consistent with guideline recommendations. What advice should be given to children and their parents/carers when they have had a UTI? No relevant evidence identified question does not need to be updated. Yes No No relevant evidence identified. CG54 UTI in children Surveillance Review Decision October of 17