Journal Club/July 31, Dore-Bergeron et al. Urinary tract infections in 1-3 month old infants: ambulatory treatment with intravenous antibiotics David H. Rubin, MD Chairman and Program Director, Pediatrics St Barnabas Hospital Professor of Clinical Pediatrics, Albert Einstein College of Medicine

OBJECTIVES OF SEMINAR  Aim  Hypothesis  Methods and statistical strategies  Conclusion  Competency based evaluation

COMPETENCY BASED EVALUATION   Review of competencies (pre-review of article)   Review of competencies (post-review of article)   Application of specific issues from article to each competency Attempt to match issues from article with specific competency

COMPETENCY BASED OBJECTIVES  Medical Knowledge knowledge about the established and evolving biomedical, clinical, and cognate (epidemiological and social- behavioral) sciences and their application to patient careknowledge about the established and evolving biomedical, clinical, and cognate (epidemiological and social- behavioral) sciences and their application to patient care

COMPETENCY BASED OBJECTIVES  Patient Care family centered patient care developmentally and age appropriate compassionate and effective for treatment of health care problems and promotion of healthfamily centered patient care developmentally and age appropriate compassionate and effective for treatment of health care problems and promotion of health

COMPETENCY BASED OBJECTIVES  Practice Based Learning investigation and evaluation of patient care, and the assimilation of scientific evidenceinvestigation and evaluation of patient care, and the assimilation of scientific evidence  Communication Skills interpersonal and communication skills resulting in effective information exchange and learning with patients, families and professional associatesinterpersonal and communication skills resulting in effective information exchange and learning with patients, families and professional associates

COMPETENCY BASED OBJECTIVES  System Based Practice understanding systems of health care organization, financing, and delivery, and the relationship of one’s local practice and these larger systemsunderstanding systems of health care organization, financing, and delivery, and the relationship of one’s local practice and these larger systems  Professionalism carrying out professional responsibilities, adherence to ethical principles, and sensitivity to diverse patient populationscarrying out professional responsibilities, adherence to ethical principles, and sensitivity to diverse patient populations

INTRODUCTION  Usual practice is to hospitalize young infants - especially those < 3 months of age with urinary tract infections due to Risk of bacteremia and other SBIRisk of bacteremia and other SBI Risk of renal scarringRisk of renal scarring  “Ambulatory treatment of UTI in the 3m-5 year group has been shown to be safe, feasible and satisfactory to parents…”  No study of same topic to date in younger age group

HYPOTHESIS/AIM OF STUDY  Specific challenges (e.g. IV access) and reluctance of ED physicians to discharge home young infants with bacterial infections during the first hours of treatment could be addressed with successful OPD treatment with IV antibiotics in a “day treatment center” in infants 1-3 months of age

METHODS   Clinical protocol established in tertiary care Canadian hospital (Montreal) in 2005 Eligible: all children days of age with diagnosis of febrile UTI LP? – at discretion of attending physician If non toxic appearing with normal renal function, subjects received:

METHODS   Single dose of IV gentamicin (2.5 or 5mg/kg) given through IV catheter   Single dose of IV ampicillin   2 or 3 doses of oral amoxicillin to be taken until 1 st visit at DTC   Parents measured rectal temperature every 4 hours during IV home therapy   Exclusion criteria (these patients were hospitalized) Age < 30 days Toxic appearing or dehydrated Abnormal renal function “Dubious parental compliance” H/O renal surgery Abnormal CSF findings Serious medical conditions

METHODS   DTC Open 7 days/week Staffed by hospitalists Treatment continued IV Gentamicin (5 mg/kg) Qday until “child was afebrile for ≥ 24 hours and urine culture results available” Oral amoxicillin discontinued when gram negative bacilli identified; after gentamicin treatment stopped, oral amoxicillin was continued for 10 days   If 1 st UTI  renal ultrasound and VCUG prior to DTC discharge

METHODS   “Retrospective cohort study” 1/1/2005-9/30/2007 Infants 1-3 months of age with first UTI and history of fever in prior 48 hours or rectal temp ≥ 48 hours in the ED Admission rosters were reviewed to find patients for the study: admitting or discharge diagnosis of UTI or pyelonephritis in 1-3 month olds

METHODS   “Retrospective cohort study” 1/1/2005-9/30/2007 Definition of UTI Suprapubic: any gm negative bacteria or > 10 X 10 6 colonies/L or Catheterized: > 50 X 10 6 colonies/L of a single pathogen or 10 X 10 6 colonies/L of pseudomonas or Treating physician decided diagnosis was UTI

STATISTICAL ANALYSIS   Multivariate and logistic regression used to determine if age was associated with “successful implementation of treatment protocol.”   “Appropriateness” of patient referral tot DTC or hospital was a major outcome variable Covariates: age ≤ 60 days, distance home to hospital < 20km, ED physician experience ≤ 10 years, time of day

STATISTICAL ANALYSIS   “Successful treatment in the DTC” Defined as: attendance at all visits, resolution of fever within 48 hours, negative control urine culture and blood culture results, and no hospitalization Covariates: age ≤ 60 days, distance home to hospital < 20km, type of bacteria in urine culture (e coli v other bacteria)

RESULTS   See Figure 1 algorithm page 18   87% of infants (102/118) were referred to appropriate site 2 sent to DTC that should have been hospitalized due to abnormal CSF   See Table 1, page 19   Adherence to protocol lower for younger patients (p>.05)

RESULTS   Diagnosis of UTI made for 86.6% of patients sent to DTC (see Table 2)   Clinical course of UTI – see Table 3, page 20   7 patients were hospitalized from DTC 5/6 children with bacteremia 1 with GERD Right hydronephrosis

RESULTS   Treatment considered “successful” for 86.2% of patients treated in DTC   7/8 treatment failures defined as “failures” because they were admitted   Differences for success rates for younger v older groups (≤ 60 d v older) due to frequency of hospitalization for younger group

DISCUSSION  Ambulatory treatment of UTI for 30-90day old infants with febrile UTI’s with short term IV treatment is “feasible.”  “Treatment failures” (7/8) due to hospital admission; patients usually admitted due to positive blood cultures and were not clinically unstable  Need to complete VCUG and sonogram soon to rule out potential pathology  Prior studies looking at oral antibiotics for febrile UTI did not include younger population

DISCUSSION  Limitations ?Generalizability of findings?Generalizability of findings Location Location Population of participants Population of participants ?Long term followup?Long term followup How was the definition of “success” created?How was the definition of “success” created? Attending physician had option to assign diagnosis of UTI without any laboratory evidenceAttending physician had option to assign diagnosis of UTI without any laboratory evidence

DISCUSSION  Strengths of the study Interesting question, importantInteresting question, important  Weaknesses of the study Population very different (generalizability limited); impossible to perform in NYCPopulation very different (generalizability limited); impossible to perform in NYC Author excluded parents who were “dubious”Author excluded parents who were “dubious”

COMPETENCY BASED OBJECTIVES  Medical Knowledge knowledge about the established and evolving biomedical, clinical, and cognate (epidemiological and social- behavioral) sciences and their application to patient careknowledge about the established and evolving biomedical, clinical, and cognate (epidemiological and social- behavioral) sciences and their application to patient care Treatment of febrile UTI in children Treatment of febrile UTI in children

COMPETENCY BASED OBJECTIVES  Patient Care family centered patient care developmentally and age appropriate compassionate and effective for treatment of health care problems and promotion of healthfamily centered patient care developmentally and age appropriate compassionate and effective for treatment of health care problems and promotion of health Parents may not understand issues surrounding UTI’s Parents may not understand issues surrounding UTI’s

COMPETENCY BASED OBJECTIVES  Practice Based Learning investigation and evaluation of patient care, and the assimilation of scientific evidenceinvestigation and evaluation of patient care, and the assimilation of scientific evidence Scientific evaluation of hypothesis, methods, and conclusion of article Scientific evaluation of hypothesis, methods, and conclusion of article  Communication Skills interpersonal and communication skills resulting in effective information exchange and learning with patients, families and professional associatesinterpersonal and communication skills resulting in effective information exchange and learning with patients, families and professional associates Parental education and support critical Parental education and support critical

COMPETENCY BASED OBJECTIVES  System Based Practice understanding systems of health care organization, financing, and delivery, and the relationship of one’s local practice and these larger systemsunderstanding systems of health care organization, financing, and delivery, and the relationship of one’s local practice and these larger systems Who gets admitted and who will pay for this? Admission warranted on medical reasons? Who gets admitted and who will pay for this? Admission warranted on medical reasons?  Professionalism carrying out professional responsibilities, adherence to ethical principles, and sensitivity to diverse patient populationscarrying out professional responsibilities, adherence to ethical principles, and sensitivity to diverse patient populations Patient education in diverse cultures Patient education in diverse cultures