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In-hospital versus out-of-hospital pediatric cardiac arrest: a multicenter cohort study

Moler, Frank W; Meert, Kathleen; Donaldson, Amy E; Nadkarni, Vinay; Brilli, Richard J; Dalton, Heidi J; Clark, Robert S B; Shaffner, Donald H; Schleien, Charles L; Statler, Kimberly; Tieves, Kelly S; Hackbarth, Richard; Pretzlaff, Robert; van der Jagt, Elise W; Levy, Fiona; Hernan, Lynn; Silverstein, Faye S; Dean, J Michael
OBJECTIVES: : To describe a large multicenter cohort of pediatric cardiac arrest (CA) with return of circulation (ROC) from either the in-hospital (IH) or the out-of-hospital (OH) setting and to determine whether significant differences related to pre-event, arrest event, early postarrest event characteristics, and outcomes exist that would be critical in planning a clinical trial of therapeutic hypothermia (TH). DESIGN: : Retrospective cohort study. SETTING: : Fifteen Pediatric Emergency Care Applied Research Network sites. PATIENTS: : Patients aged 24 hours to 18 years with either IH or OH CA who had a history of at least 1 minute of chest compressions and ROC for at least 20 minutes were eligible. INTERVENTIONS: : None. MEASUREMENTS AND MAIN RESULTS: : A total of 491 patients met study entry criteria with 353 IH cases and 138 OH cases. Major differences between the IH and OH cohorts were observed for patient prearrest characteristics, arrest event initial rhythm described, and arrest medication use. Several postarrest interventions were used differently, however, the use of TH was similar (<5%) in both cohorts. During the 0-12-hour interval following ROC, OH cases had lower minimum temperature and pH, and higher maximum serum glucose recorded. Mortality was greater in the OH cohort (62% vs. 51%, p = 0.04) with the cause attributed to a neurologic indication much more frequent in the OH than in the IH cohort (69% vs. 20%; p < 0.01). CONCLUSIONS: : For pediatric CA with ROC, several major differences exist between IH and OH cohorts. The finding that the etiology of death was attributed to neurologic indications much more frequently in OH arrests has important implications for future research. Investigators planning to evaluate the efficacy of new interventions, such as TH, should be aware that the IH and OH populations differ greatly and require independent clinical trials.
PMCID:2711020
PMID: 19455024
ISSN: 0090-3493
CID: 1155132

Limitations in the agency for healthcare research and quality pediatric quality indicators result in flawed call for national benchmarks [Letter]

Scanlon, Matthew C; Harris, J Mitchell; Levy, Fiona; Sedman, Aileen
PMID: 18829820
ISSN: 0031-4005
CID: 1155182

Evaluation of the agency for healthcare research and quality pediatric quality indicators

Scanlon, Matthew C; Harris, J Mitchell 2nd; Levy, Fiona; Sedman, Aileen
OBJECTIVES: Pediatric quality indicators were developed in 2006 by the Agency for Healthcare Research and Quality to identify potentially preventable complications in hospitalized children. Our objectives for this study were to (1) apply these algorithms to an aggregate children's hospital's discharge abstract database, (2) establish rates for each of the pediatric quality indicator events in the children's hospitals, (3) use direct chart review to investigate the accuracy of the pediatric quality indicators, (4) calculate the number of complications that were already present on admission and, therefore, not attributable to the specific hospitalization, and (5) evaluate preventability and calculate positive predictive value for each of the indicators. In addition, we wanted to use the data to set priorities for ongoing clinical investigation. METHODS: The Agency for Healthcare Research and Quality pediatric quality indicator algorithms were applied to 76 children's hospital's discharge abstract data (1794675 discharges) from 2003 to 2005. Rates were calculated for 11 of the pediatric quality indicators from all 3 years of discharge data: accidental puncture or laceration, decubitus ulcer, foreign body left in during a procedure, iatrogenic pneumothorax in neonates at risk, iatrogenic pneumothorax in nonneonates, postoperative hemorrhage or hematoma, postoperative respiratory failure, postoperative sepsis, postoperative wound dehiscence, selected infections caused by medical care, and transfusion reaction. Subsequently, clinicians from 28 children's hospitals reviewed 1703 charts in which complications had been identified. They answered questions as to correctness of secondary diagnoses that were associated with the indicator, whether a complication was already present on admission, and whether that complication was preventable, nonpreventable, or uncertain. RESULTS: Across 3 years of data the rates of pediatric quality indicators ranged from a low of 0.01/1000 discharges for transfusion reaction to a high of 35/1000 for postoperative respiratory failure, with a median value of 1.85/1000 for the 11 pediatric quality indicators. Indicators were often already present on admission and ranged from 43% for infection caused by medical care to 0% for iatrogenic pneumothorax in neonates, with a median value of 16.9%. Positive predictive value for the subset of pediatric quality indicators occurring after admission was highest for decubitus ulcer (51%) and infection caused by medical care (40%). Because of the very large numbers of cases identified and its low preventability, the indicator postoperative respiratory failure is particularly problematic. The initial definition includes all children on ventilators postoperatively for >4 days with few exclusions. Being on a ventilator for 4 days would be a normal occurrence for many children with extensive surgery; therefore, the majority of the time does not indicate a complication and makes the indicator inappropriate. CONCLUSIONS: A subset of pediatric quality indicators derived from administrative data are reasonable screening tools to help hospitals prioritize chart review and subsequent improvement projects. However, in their present form, true preventability of these complications is relatively low; therefore, the indicators are not useful for public hospital comparison. Identifying which complications are present on admission versus those that occur within the hospitalization will be essential, along with adequate risk adjustment, for any valid comparison between institutions. Infection caused by medical care and decubitus ulcers are clinically important indicators once the present-on-admission status is determined. These complications cause significant morbidity in hospitalized children, and research has shown a high level of preventability. The pediatric quality indicator software can help children's hospitals objectively review their cases and target improvement activities appropriately. The postoperative-respiratory-failure indicator does not represent a complication in the majority of cases and, therefore, should not be included for hospital screening or public comparison. Chart review should become part of the development process for quality indicators to avoid inappropriate conclusions that misdirect quality-improvement resources.
PMID: 18474532
ISSN: 0031-4005
CID: 1155192

A novel error-reporting tool in pediatric intensive care

Kolovos, Nikoleta S; Bratton, Susan L; Levy, Fiona H
Patient safety is a critical component of the U.S. healthcare system: thousands of people, including children, die or are injured yearly as a result of medical error. We designed and implemented a novel error-reporting tool for the pediatric intensive care unit. More errors were reported with the use of this paper-based tool than with the existing computerized error-reporting system. We also developed a scoring system to assess potential harm to the patient. The tool provided information about frequent and high-risk errors that guided successful improvements in patient care and safety and the achievement of measurable success.
PMID: 18507240
ISSN: 1062-2551
CID: 1155062

Journey toward meaningful pediatric quality metric reporting: the Texas experience

Levy, Fiona H; Henion, Julia S; Harris, J Mitchell 2nd
Working under a mandate for public reporting, children's hospitals in Texas joined in a partnership with the state with the intent of working toward providing meaningful assessment of the quality of pediatric inpatient care. This article summarizes a journey of nearly 2 years undertaken to review currently available quality measures and arrive at interagency consensus for the reporting of pediatric quality and clinical outcomes in Texas. Public reporting has been approached with great divergence across the states. The Texas project underlines the need for all interested parties to collaborate for best results.
PMID: 18507239
ISSN: 1062-2551
CID: 1155072

Technology and pediatric patient safety: what to target is the dilemma [Comment]

Levy, Fiona Howard
PMID: 18206678
ISSN: 0022-3476
CID: 1155142

Off-label drug use in hospitalized children

Shah, Samir S; Hall, Matthew; Goodman, Denise M; Feuer, Pamela; Sharma, Vidya; Fargason, Crayton Jr; Hyman, Daniel; Jenkins, Kathy; White, Marjorie L; Levy, Fiona H; Levin, James E; Bertoch, David; Slonim, Anthony D
OBJECTIVES: To describe the magnitude of off-label drug use, to identify drugs most commonly used off-label, and to identify factors associated with off-label drug use in children hospitalized in the United States. DESIGN: Retrospective cohort study. SETTING: Administrative database containing inpatient resource utilization data from January 1 to December 31, 2004, from 31 tertiary care pediatric hospitals in the United States. PARTICIPANTS: Hospitalized patients 18 years or younger. MAIN EXPOSURES: Institution and patient characteristics. MAIN OUTCOME MEASURES: Off-label drug use was defined as use of a specific drug in a patient younger than the Food and Drug Administration-approved age range for any indication of that drug. RESULTS: At least 1 drug was used off-label in 297 592 (78.7%) of 355 409 patients discharged during the study. Off-label use accounted for $270 275 849 (40.5%) of the total dollars spent on these medications. Medications classified as central or autonomic nervous system agents or as fluids or nutrients, or gastrointestinal tract agents were most commonly used off-label, whereas antineoplastic agents were rarely used off-label. Factors associated with off-label use in multivariate analysis were as follows: undergoing a surgical procedure, age older than 28 days, greater severity of illness, and all-cause in-hospital mortality. CONCLUSIONS: Most patients hospitalized at tertiary care pediatric institutions receive at least 1 medication outside the terms of the Food and Drug Administration product license. Substantial variation in the frequency of off-label use was observed across diagnostic categories and drug classes. Despite the frequent off-label use of drugs, using an administrative database, we cannot determine which of these treatments are unsafe or ineffective and which treatments result in substantial benefit to the patient.
PMID: 17339510
ISSN: 1072-4710
CID: 1155082

Regional variation in ICU care for pediatric patients with asthma

Bratton, Susan L; Odetola, Folafoluwa O; McCollegan, Jamie; Cabana, Michael D; Levy, Fiona H; Keenan, Heather T
OBJECTIVE: To determine adherence to guidelines for severe asthma care and evaluate regional variability in practice among pediatric intensive care units (PICU). STUDY DESIGN: A retrospective cohort study of children treated for asthma in a PICU during 2000 to 2003. We utilized the Pediatric Health Information System (PHIS) database to identify patients and determine use of asthma therapies when patients did not improve with standard therapy (inhaled beta-agonists and systemic corticosteroids). RESULTS: Of 7125 children studied, 59% received inhaled anticholinergic medications. Use of other therapies included systemic beta-agonists (n = 1841 [26%]), magnesium sulfate (n = 1521 [21%]), methylxanthines (n = 426 [6%]), inhaled helium-oxygen gas mixture (heliox) (n = 740 [10%]), and endotracheal intubation with ventilation (n=1024 [14%]). Use of therapies varied by census region. Over half the patients (n = 524) who received ventilation did so for < or = 1 day. Adjusted for severity of illness, use of mechanical ventilation varied significantly by census division; however, much of the variation was among children ventilated for < or = 1 day. CONCLUSION: Adherence to national guidelines for use of inhaled anticholinergics among critically ill children is low, and marked variation in use of invasive ventilation exists. More explicit guidelines regarding indications for invasive ventilation may improve asthma care.
PMID: 16182675
ISSN: 0022-3476
CID: 1155092

The effect of surgical case volume on outcome after the Norwood procedure

Checchia, Paul A; McCollegan, Jamie; Daher, Noha; Kolovos, Nikoleta; Levy, Fiona; Markovitz, Barry
OBJECTIVES: We analyze the effect of surgical case volume on the survival of infants with hypoplastic left heart syndrome who underwent stage I surgical palliation (the Norwood procedure). The purpose of our study was to understand more clearly the relative effects of institution and surgeon experience on patient outcome. METHODS: Using the Pediatric Health Information System database belonging to the pediatric hospital members of the Child Health Corporation of America, we identified newborn infants (< 30 days old on admission) from 1998 through 2001 admitted with the diagnosis of hypoplastic left heart syndrome. Stepwise multiple regression analysis was used to examine the association between both institutional and surgeon case volume with 28-day survival after the Norwood procedure. RESULTS: Twenty-nine hospitals and 87 surgeons performed 801 Norwood procedures during the study period. In the 4 of 29 institutions that averaged 1 or more Norwood procedures per month during the study period, survival averaged 78%. The remaining 25 institutions averaged 1 Norwood procedure every 9.6 weeks, with a survival of 59%. Data analysis revealed that higher institutional volume (P = .02) but not the number of cases performed by surgeons (P = .13) increased survival after the Norwood procedure. There was no such association with average length of stay in survivors or the time to mortality in nonsurvivors. CONCLUSION: Survival after the Norwood procedure is associated with institutional Norwood procedure volume but not with individual surgeon case volume, suggesting the need for improvements in institutional-based approaches to the care of children with hypoplastic left heart syndrome and the need for establishing regional referral centers for such high-risk procedures to improve patient survival.
PMID: 15821640
ISSN: 0022-5223
CID: 1155152

Amino acid clearance during acute metabolic decompensation in maple syrup urine disease treated with continuous venovenous hemodialysis with filtration [Case Report]

Hmiel, Stanley Paul; Martin, Rick A; Landt, Michael; Levy, Fiona H; Grange, Dorothy K
OBJECTIVE: Assessment of amino acid clearances by continuous venovenous hemodialysis with filtration in treatment of a metabolic decompensation in acute maple syrup urine disease. DESIGN: Single patient assessment. SETTING: Pediatric intensive care unit. PATIENTS: A 10-yr-old male with known maple syrup urine disease (branched chain alpha-ketoacid dehydrogenase deficiency) with metabolic decompensation due to an acute viral illness, characterized by altered mental status, progressive obtundation, and severe acidosis. INTERVENTIONS: Continuous venovenous hemodialysis with filtration. MEASUREMENTS AND MAIN RESULTS: Continuous venovenous hemodialysis with filtration was instituted with both filtration (500 mL/m(2)/hr) and dialysis (1000 mL/m(2)/hr) utilized, allowing rapid correction of systemic ketoacidosis while providing amino acid clearance. Amino acid clearance was measured at initiation and at 24 hrs into therapy. The procedure was well tolerated, with near normal mental status within 12 hrs and resumption of enteral feedings. During the 24-hr period of continuous venovenous hemodialysis with filtration, serum leucine levels fell from 2352 to 381 micromoles/L, isoleucine fell from 626 to 164, and valine fell from 1117 to 228. Leucine, isoleucine, and valine clearance rates averaged 13.1, 12.8, and 13.2 mL/min, respectively, and were constant during the 24 hrs of treatment. Clearance of other amino acids during this period did not vary significantly between cationic, anionic, neutral, or hydrophobic amino acids. CONCLUSIONS: Continuous venovenous hemodialysis with filtration provides an effective therapeutic alternative to intermittent hemodialysis during acute metabolic decompensation in maple syrup urine disease.
PMID: 15115568
ISSN: 1529-7535
CID: 1155102