Ron Keren

Is antibiotic prophylaxis in children with vesicoureteral reflux effective in preventing pyelonephritis and renal scars? A randomized, controlled trial

OBJECTIVES. There has been intense discussion on the effectiveness of continuous antibiotic prophylaxis for children with vesicoureteral reflux, and randomized, controlled trials are still needed to determine the effectiveness of long-term antibiotics for the prevention of acute pyelonephritis. In this multicenter, open-label, randomized, controlled trial, we tested the effectiveness of antibiotic prophylaxis in preventing recurrence of pyelonephritis and avoiding new scars in a sample of children who were younger than 30 months and vesicoureteral reflux. METHODS. One hundred patients with vesicoureteral reflux (grade II, III, or IV) diagnosed with cystourethrography after a first episode of acute pyelonephritis were randomly assigned to receive antibiotic prophylaxis with sulfamethoxazole/trimethoprim or not for 2 years. The main outcome of the study was the recurrence of pyelonephritis during a follow-up period of 4 years. During follow-up, the patients were evaluated through repeated cystourethrographies, renal ultrasounds, and dimercaptosuccinic acid scans. RESULTS. The baseline characteristics in the 2 study groups were similar. There were no differences in the risk for having at least 1 pyelonephritis episode between the intervention and control groups. At the end of follow-up, the presence of renal scars was the same in children with and without antibiotic prophylaxis. CONCLUSIONS. Continuous antibiotic prophylaxis was ineffective in reducing the rate of pyelonephritis recurrence and the incidence of renal damage in children who were younger than 30 months and had vesicoureteral reflux grades II through IV.

Prioritization of Comparative Effectiveness Research Topics in Hospital Pediatrics

OBJECTIVEnTo use information about prevalence, cost, and variation in resource utilization to prioritize comparative effectiveness research topics in hospital pediatrics.nnnDESIGNnRetrospective analysis of administrative and billing data for hospital encounters.nnnSETTINGnThirty-eight freestanding US childrens hospitals from January 1, 2004, through December 31, 2009.nnnPARTICIPANTSnChildren hospitalized with conditions that accounted for either 80% of all encounters or 80% of all charges.nnnMAIN OUTCOME MEASURESnCondition-specific prevalence, total standardized cost, and interhospital variation in mean standardized cost per encounter, measured in 2 ways: (1) intraclass correlation coefficient, which represents the fraction of total variation in standardized costs per encounter due to variation between hospitals; and (2) number of outlier hospitals, defined as having more than 30% of encounters with standardized costs in either the lowest or highest quintile across all encounters.nnnRESULTSnAmong 495 conditions accounting for 80% of all charges, the 10 most expensive conditions accounted for 36% of all standardized costs. Among the 50 most prevalent and 50 most costly conditions (77 in total), 26 had intraclass correlation coefficients higher than 0.10 and 5 had intraclass correlation coefficients higher than 0.30. For 10 conditions, more than half of the hospitals met outlier hospital criteria. Surgical procedures for hypertrophy of tonsils and adenoids, otitis media, and acute appendicitis without peritonitis were high cost, were high prevalence, and displayed significant variation in interhospital cost per encounter.nnnCONCLUSIONSnDetailed administrative and billing data can be used to standardize hospital costs and identify high-priority conditions for comparative effectiveness research--those that are high cost, are high prevalence, and demonstrate high variation in resource utilization.

Effectiveness of Decision Support for Families, Clinicians, or Both on HPV Vaccine Receipt

OBJECTIVE: To improve human papillomavirus (HPV) vaccination rates, we studied the effectiveness of targeting automated decision support to families, clinicians, or both. METHODS: Twenty-two primary care practices were cluster-randomized to receive a 3-part clinician-focused intervention (education, electronic health record-based alerts, and audit and feedback) or none. Overall, 22u2009486 girls aged 11 to 17 years due for HPV vaccine dose 1, 2, or 3 were randomly assigned within each practice to receive family-focused decision support with educational telephone calls. Randomization established 4 groups: family-focused, clinician-focused, combined, and no intervention. We measured decision support effectiveness by final vaccination rates and time to vaccine receipt, standardized for covariates and limited to those having received the previous dose for HPV #2 and 3. The 1-year study began in May 2010. RESULTS: Final vaccination rates for HPV #1, 2, and 3 were 16%, 65%, and 63% among controls. The combined intervention increased vaccination rates by 9, 8, and 13 percentage points, respectively. The control group achieved 15% vaccination for HPV #1 and 50% vaccination for HPV #2 and 3 after 318, 178, and 215 days. The combined intervention significantly accelerated vaccination by 151, 68, and 93 days. The clinician-focused intervention was more effective than the family-focused intervention for HPV #1, but less effective for HPV #2 and 3. CONCLUSIONS: A clinician-focused intervention was most effective for initiating the HPV vaccination series, whereas a family-focused intervention promoted completion. Decision support directed at both clinicians and families most effectively promotes HPV vaccine series receipt.

The Generation Gap: Differences Between Children and Adults Pertinent to Economic Evaluations of Health Interventions

AbstractDifferences between children and adults have both technical and ethical implications for the design, interpretation and employment of economic analyses of health-related programmes. Even though policy makers increasingly turn to economic analyses to inform decisions about resource allocation, pertinent child-adult differences have received fragmented discussion in leading methodological references.Key areas warranting attention include: the ways in which a child’s distinctive biology modifies the cost and effectiveness of healthcare interventions; challenges in assessing utilities for infants and young children given their limited but developing cognitive capacity; how a child’s age, dependency and disability affect the selection of the appropriate time horizon and scope of the analysis; whether a child’s non-wage earning productivity should be incorporated into analyses, and if so, what metric to use; what principles of equity policy makers should employ in using economic evaluations to choose between child- and adult-focused interventions; and whether special protective measures should be introduced to secure the rights and interests of children who cannot advocate for themselves.n

Measuring Health Preferences for Use in Cost-Utility and Cost-Benefit Analyses of Interventions in Children: Theoretical and Methodological Considerations

Valuing the health of children for cost-utility or cost-benefit analysis poses a number of additional challenges when compared with valuing adult health. Some of these challenges relate to the inability of young children to value changes in health directly and the potential biases associated with using proxy respondents. Other challenges arise from children not being able to perform as independent economic actors, but dependent on others for care and decision making. In addition, illness in children may affect parent/caregiver quality of life, further complicating the measurement of value associated with a change in a child’s health status.We review the most common approaches (QALYs and willingness-to-pay values) for valuing health in economic evaluations and consider the methodological and practical issues associated with measuring child health using each framework. Recommendations for advancing the field of valuing child health for economic evaluations will vary by age; a ‘one size fits all’ approach does not readily fit. Although limitations exist for all of the methods considered for valuing child health, the currently recommended approach for infants and preschoolers is direct valuation by a proxy respondent. For school-age children and adolescents, existing multi-attribute instruments can be applied in some situations but direct valuation may be required for others. Future research should focus on minimising bias from proxy respondents, consideration of a family- or household-based approach to valuing health effects, and development of generic instruments with domains that are appropriate to children and that vary with age.

Complications of Central Venous Catheters Used for the Treatment of Acute Hematogenous Osteomyelitis

OBJECTIVE. To determine the complications and risk factors for complications associated with using central venous catheters (CVCs) for the treatment of acute hematogenous osteomyelitis (AHO). METHODS. We conducted a retrospective cohort study of all patients admitted to the Children’s Hospital of Philadelphia between January 1, 2000, and December 31, 2003, with a diagnosis of AHO. RESULTS. Eighty patients with AHO met inclusion criteria. The median age was 5 years, and 66% of the patients were male. The most commonly affected bones were the femur (25%), tibia (20%), and pelvis (16%). Staphylococcus aureus was the most common organism identified from cultures of bone (67%) and blood (30%). Seventy-five patients (94%) received >2 weeks of intravenous (IV) antibiotic therapy via a CVC and 5 (6%) received <2 weeks of IV antibiotic therapy before conversion to oral therapy for a median of 25 days. None of the patients who switched to oral therapy within 2 weeks was rehospitalized or returned to the emergency department. Of the 75 patients who received >2 weeks of IV therapy, 41% had ≥1 CVC-associated complication. Seventeen patients (23%) had a CVC malfunction or displacement, 8 (11%) had a catheter-associated bloodstream infection, 8 (11%) had fever with negative blood culture results, and 4 (5%) had a local skin infection at the site of catheter insertion. Older age was protective against the development of a CVC-associated complication, whereas the lowest median household income was associated with development of a CVC-associated complication. CONCLUSIONS. Interventions to reduce CVC-associated complications should be developed and evaluated, particularly for young children and those from families with low household incomes. Clinical trials are needed to evaluate the safety and efficacy of oral antibiotic therapy after a short course of IV therapy as an alternative to prolonged IV therapy.

Impact of Rapid Response System Implementation on Critical Deterioration Events in Children

IMPORTANCEnRapid response systems aim to identify and rescue deteriorating hospitalized patients. Previous pediatric rapid response system implementation studies have shown variable effectiveness in preventing rare, catastrophic outcomes such as cardiac arrest and death.nnnOBJECTIVEnTo evaluate the impact of pediatric rapid response system implementation inclusive of a medical emergency team and an early warning score on critical deterioration, a proximate outcome defined as unplanned transfer to the intensive care unit with noninvasive or invasive mechanical ventilation or vasopressor infusion in the 12 hours after transfer.nnnDESIGN, SETTING, AND PARTICIPANTSnQuasi-experimental study with interrupted time series analysis using piecewise regression. At an urban, tertiary care childrens hospital in the United States, we evaluated 1810 unplanned transfers from the general medical and surgical wards to the pediatric and neonatal intensive care units that occurred during 370,504 non-intensive care patient-days between July 1, 2007, and May 31, 2012.nnnINTERVENTIONSnImplementation of a hospital-wide rapid response system inclusive of a medical emergency team and an early warning score in February 2010.nnnMAIN OUTCOMES AND MEASURESnRate of critical deterioration events, adjusted for season, ward, and case mix.nnnRESULTSnRapid response system implementation was associated with a significant downward change in the preintervention trajectory of critical deterioration and a 62% net decrease relative to the preintervention trend (adjusted incidence rate ratiou2009=u20090.38; 95% CI, 0.20-0.75). We observed absolute reductions in ward cardiac arrests (from 0.03 to 0.01 per 1000 non-intensive care patient-days) and deaths during ward emergencies (from 0.01 to 0.00 per 1000 non-intensive care patient-days), but these were not statistically significant (Pu2009=u2009.21 and Pu2009=u2009.99, respectively). Among all unplanned transfers, critical deterioration was associated with a 4.97-fold increased risk of death (95% CI, 3.33-7.40; Pu2009<u2009.001).nnnCONCLUSIONS AND RELEVANCEnRapid response system implementation reversed an increasing trend of critical deterioration. Cardiac arrest and death were extremely rare at baseline, and their reductions were not statistically significant despite using nearly 5 years of data. Hospitals seeking to measure rapid response system performance may consider using valid proximate outcomes like critical deterioration in addition to rare, catastrophic outcomes.

Comparative Effectiveness of Intravenous vs Oral Antibiotics for Postdischarge Treatment of Acute Osteomyelitis in Children

IMPORTANCEnPostdischarge treatment of acute osteomyelitis in children requires weeks of antibiotic therapy, which can be administered orally or intravenously via a peripherally inserted central catheter (PICC). The catheters carry a risk for serious complications, but limited evidence exists on the effectiveness of oral therapy.nnnOBJECTIVEnTo compare the effectiveness and adverse outcomes of postdischarge antibiotic therapy administered via the PICC or the oral route.nnnDESIGN, SETTING, AND PARTICIPANTSnWe performed a retrospective cohort study comparing PICC and oral therapy for the treatment of acute osteomyelitis. Among children hospitalized from January 1, 2009, through December 31, 2012, at 36 participating childrens hospitals, we used discharge codes to identify potentially eligible participants. Results of medical record review confirmed eligibility and defined treatment group allocation and study outcomes. We used within- and across-hospital propensity score-based full matching to adjust for confounding by indication.nnnINTERVENTIONSnPostdischarge administration of antibiotics via the PICC or the oral route.nnnMAIN OUTCOMES AND MEASURESnThe primary outcome was treatment failure. Secondary outcomes included adverse drug reaction, PICC line complication, and a composite of all 3 end points.nnnRESULTSnAmong 2060 children and adolescents (hereinafter referred to as children) with osteomyelitis, 1005 received oral antibiotics at discharge, whereas 1055 received PICC-administered antibiotics. The proportion of children treated via the PICC route varied across hospitals from 0 to 100%. In the across-hospital (risk difference, 0.3% [95% CI, -0.1% to 2.5%]) and within-hospital (risk difference, 0.6% [95% CI, -0.2% to 3.0%]) matched analyses, children treated with antibiotics via the oral route (reference group) did not experience more treatment failures than those treated with antibiotics via the PICC route. Rates of adverse drug reaction were low (<4% in both groups) but slightly greater in the PICC group in across-hospital (risk difference, 1.7% [95% CI, 0.1%-3.3%]) and within-hospital (risk difference, 2.1% [95% CI, 0.3%-3.8%]) matched analyses. Among the children in the PICC group, 158 (15.0%) had a PICC complication that required an emergency department visit (nu2009=u200996), a rehospitalization (nu2009=u200938), or both (nu2009=u200924). As a result, the PICC group had a much higher risk of requiring a return visit to the emergency department or for hospitalization for any adverse outcome in across-hospital (risk difference, 14.6% [95% CI, 11.3%-17.9%]) and within-hospital (risk difference, 14.0% [95% CI, 10.5%-17.6%]) matched analyses.nnnCONCLUSIONS AND RELEVANCEnGiven the magnitude and seriousness of PICC complications, clinicians should reconsider the practice of treating otherwise healthy children with acute osteomyelitis with prolonged intravenous antibiotics after hospital discharge when an equally effective oral alternative exists.

Variation in Quality of Tonsillectomy Perioperative Care and Revisit Rates in Children’s Hospitals

OBJECTIVE: To describe the quality of care for routine tonsillectomy at US children’s hospitals. METHODS: We conducted a retrospective cohort study of low-risk children undergoing same-day tonsillectomy between 2004 and 2010 at 36 US children’s hospitals that submit data to the Pediatric Health Information System Database. We assessed quality of care by measuring evidence-based processes suggested by national guidelines, perioperative dexamethasone and no antibiotic use, and outcomes, 30-day tonsillectomy-related revisits to hospital. RESULTS: Of 139u2009715 children who underwent same-day tonsillectomy, 10u2009868 (7.8%) had a 30-day revisit to hospital. There was significant variability in the administration of dexamethasone (median 76.2%, range 0.3%–98.8%) and antibiotics (median 16.3%, range 2.7%–92.6%) across hospitals. The most common reasons for revisits were bleeding (3.0%) and vomiting and dehydration (2.2%). Older age (10–18 vs 1–3 years) was associated with a greater standardized risk of revisits for bleeding and a lower standardized risk of revisits for vomiting and dehydration. After standardizing for differences in patients and year of surgery, there was significant variability (P < .001) across hospitals in total revisits (median 7.8%, range 3.0%–12.6%), revisits for bleeding (median 3.0%, range 1.0%–8.8%), and revisits for vomiting and dehydration (median 1.9%, range 0.3%–4.4%). CONCLUSIONS: Substantial variation exists in the quality of care for routine tonsillectomy across US children’s hospitals as measured by perioperative dexamethasone and antibiotic use and revisits to hospital. These data on evidence-based processes and relevant patient outcomes should be useful for hospitals’ tonsillectomy quality improvement efforts.

Annual Incidence of Nephrolithiasis among Children and Adults in South Carolina from 1997 to 2012

BACKGROUND AND OBJECTIVESnThe prevalence of nephrolithiasis in the United States has increased substantially, but recent changes in incidence with respect to age, sex, and race are not well characterized. This study examined temporal trends in the annual incidence and cumulative risk of nephrolithiasis among children and adults living in South Carolina over a 16-year period.nnnDESIGN, SETTING, PARTICIPANTS, & MEASUREMENTSnWe performed a population-based, repeated cross-sectional study using the US Census and South Carolina Medical Encounter data, which capture all emergency department visits, surgeries, and admissions in the state. The annual incidence of nephrolithiasis in South Carolina from 1997 to 2012 was estimated, and linear mixed models were used to estimate incidence rate ratios for age, sex, and racial groups. The cumulative risk of nephrolithiasis during childhood and over the lifetime was estimated for males and females in 1997 and 2012.nnnRESULTSnAmong an at-risk population of 4,625,364 people, 152,925 unique patients received emergency, inpatient, or surgical care for nephrolithiasis. Between 1997 and 2012, the mean annual incidence of nephrolithiasis increased 1% annually from 206 to 239 per 100,000 persons. Among age groups, the greatest increase was observed among 15-19 year olds, in whom incidence increased 26% per 5 years (incidence rate ratio, 1.26; 95% confidence interval, 1.22 to 1.29). Adjusting for age and race, incidence increased 15% per 5 years among females (incidence rate ratio, 1.15; 95% confidence interval, 1.14 to 1.16) but remained stable for males. The incidence among blacks increased 15% more per 5 years compared with whites (incidence rate ratio, 1.15; 95% confidence interval, 1.14 to 1.17). These changes in incidence resulted in doubling of the risk of nephrolithiasis during childhood and a 45% increase in the lifetime risk of nephrolithiasis for women over the study period.nnnCONCLUSIONSnThe incidence of kidney stones has increased among young patients, particularly women, and blacks.