A Comparison of Data Quality Assessment Checks in Six Data Sharing Networks.

OBJECTIVE: To compare rule-based data quality (DQ) assessment approaches across multiple national clinical data sharing organizations. METHODS: Six organizations with established data quality assessment (DQA) programs provided documentation or source code describing current DQ checks. DQ checks were mapped to the categories within the data verification context of the harmonized DQA terminology. To ensure all DQ checks were consistently mapped, conventions were developed and four iterations of mapping performed. Difficult-to-map DQ checks were discussed with research team members until consensus was achieved. RESULTS: Participating organizations provided 11,026 DQ checks, of which 99.97 percent were successfully mapped to a DQA category. Of the mapped DQ checks (N=11,023), 214 (1.94 percent) mapped to multiple DQA categories. The majority of DQ checks mapped to Atemporal Plausibility (49.60 percent), Value Conformance (17.84 percent), and Atemporal Completeness (12.98 percent) categories. DISCUSSION: Using the common DQA terminology, near-complete (99.97 percent) coverage across a wide range of DQA programs and specifications was reached. Comparing the distributions of mapped DQ checks revealed important differences between participating organizations. This variation may be related to the organization's stakeholder requirements, primary analytical focus, or maturity of their DQA program. Not within scope, mapping checks within the data validation context of the terminology may provide additional insights into DQA practice differences. CONCLUSION: A common DQA terminology provides a means to help organizations and researchers understand the coverage of their current DQA efforts as well as highlight potential areas for additional DQA development. Sharing DQ checks between organizations could help expand the scope of DQA across clinical data networks.

Effect of Inhaled Nitric Oxide on Outcomes in Children With Acute Lung Injury: Propensity Matched Analysis From a Linked Database.

OBJECTIVES: To evaluate the effect of inhaled nitric oxide on outcomes in children with acute lung injury. DESIGN: Retrospective study with a secondary data analysis of linked data from two national databases. Propensity score matching was performed to adjust for potential confounding variables between patients who received at least 24 hours of inhaled nitric oxide (inhaled nitric oxide group) and those who did not receive inhaled nitric oxide (no inhaled nitric oxide group). SETTING: Linked data from Virtual Pediatric Systems (LLC) database and Pediatric Health Information System. PATIENTS: Patients less than 18 years old receiving mechanical ventilation for acute lung injury at nine participating hospitals were included (2009-2014). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 20,106 patients from nine hospitals were included. Of these, 859 patients (4.3%) received inhaled nitric oxide for at least 24 hours during their hospital stay. Prior to matching, patients in the inhaled nitric oxide group were younger, with more comorbidities, greater severity of illness scores, higher prevalence of cardiopulmonary resuscitation, and greater resource utilization. Before matching, unadjusted outcomes, including mortality, were worse in the inhaled nitric oxide group (inhaled nitric oxide vs no inhaled nitric oxide; 25.7% vs 7.9%; p < 0.001; standardized mortality ratio, 2.6 [2.3-3.1] vs 1.1 [1.0-1.2]; p < 0.001). Propensity score matching of 521 patient pairs revealed no difference in mortality in the two groups (22.3% vs 20.2%; p = 0.40; standardized mortality ratio, 2.5 [2.1-3.0] vs 2.3 [1.9-2.8]; p = 0.53). However, the other outcomes such as ventilation free days (10.1 vs 13.6 d; p < 0.001), duration of mechanical ventilation (13.8 vs 10.1 d; p < 0.001), duration of ICU and hospital stay (15.5 vs 12.2 d; p < 0.001 and 28.0 vs 24.1 d; p < 0.001), and hospital costs ($150,569 vs $102,823; p < 0.001) were significantly worse in the inhaled nitric oxide group. CONCLUSIONS: This large observational study demonstrated that inhaled nitric oxide administration in children with acute lung injury was not associated with improved mortality. Rather, it was associated with increased hospital utilization and hospital costs.

Report of the National Heart, Lung, and Blood Institute Working Group: An Integrated Network for Congenital Heart Disease Research.

The National Heart, Lung, and Blood Institute convened a working group in January 2015 to explore issues related to an integrated data network for congenital heart disease research. The overall goal was to develop a common vision for how the rapidly increasing volumes of data captured across numerous sources can be managed, integrated, and analyzed to improve care and outcomes. This report summarizes the current landscape of congenital heart disease data, data integration methodologies used across other fields, key considerations for data integration models in congenital heart disease, and the short- and long-term vision and recommendations made by the working group.

Prolonged intravenous therapy versus early transition to oral antimicrobial therapy for acute osteomyelitis in children.

OBJECTIVES: Early transition from intravenous to oral antimicrobial therapy for acute osteomyelitis in children has been suggested as a safe and effective alternative to traditional prolonged intravenous therapy via central venous catheter, but no studies have directly compared these 2 treatment modalities. We sought to compare the effectiveness of early transition from intravenous to oral antimicrobial therapy versus prolonged intravenous antimicrobial therapy for the treatment of children with acute osteomyelitis. METHODS: We conducted a retrospective cohort study of children aged 2 months to 17 years diagnosed with acute osteomyelitis between 2000 and 2005 at 29 freestanding children's hospitals in the United States to confirm the extent of variation in the use of early transition to oral therapy. We used propensity scores to adjust for potential differences between children treated with prolonged intravenous therapy and logistic regression to model the association of outcome (treatment failure rates within 6 months of diagnosis) and difference in the mode of therapy within hospitals and across hospitals. RESULTS: Of the 1969 children who met inclusion criteria, 1021 received prolonged intravenous therapy and 948 received oral therapy. The use of prolonged intravenous therapy varied significantly across hospitals (10%-95%). The treatment failure rate was 5% (54 of 1021) in the prolonged intravenous therapy group and 4% (38 of 948) in the oral therapy group. There was no significant association between treatment failure and the mode of antimicrobial therapy. Thirty-five (3.4%) children in the prolonged intravenous therapy group were readmitted for a catheter-associated complication. CONCLUSIONS: Treatment of acute osteomyelitis with early transition to oral therapy is not associated with a higher risk of treatment failures and avoids the risks of prolonged intravenous therapy through central venous catheters.

Off-label drug use in hospitalized children.

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.

Tailoring the Institute for Health Care Improvement 100,000 Lives Campaign to pediatric settings: the example of ventilator-associated pneumonia.

In December 2004, the Institute for Healthcare Improvement launched a campaign to save 100,000 lives by implementing evidence-based interventions in six areas, five of which are relevant to children. Working collaboratively, the Child Health Corporation of America, National Associate of Children's Hospitals and Related Institutions, and National Initiative for Children's Health Care Quality provided a series of Web-enabled seminars on how the campaign initiatives might be adapted for pediatric settings. Ventilator-associated pneumonia (VAP) is an example of how interventions based on evidence in adult settings may need to be tailored in pediatric settings. The authors describe how assessing and implementing parts of the VAP bundle led to reduction in VAP in two children's hospitals.

A retrospective cohort study of prognostic factors associated with outcome in pediatric severe sepsis: what is the role of steroids?

OBJECTIVE: Systemic corticosteroids remain controversial in the treatment of pediatric patients with severe sepsis. Recent studies in septic adults have shown decreased mortality with the use of hydrocortisone in patients with relative adrenal insufficiency. We conducted this large retrospective cohort study to further characterize severe sepsis in infants and children and correlates of outcome, including the use of steroids. DESIGN: Retrospective cohort study. SETTING: The Pediatric Health Information System (PHIS), an administrative database of the Child Health Corporation of America (CHCA), was queried for inpatients 0-17 yrs of age with severe sepsis (defined here as an International Classification of Disease 9th edition code for infection with use of simultaneous mechanical ventilation and vasoactive infusions) from 2001 to 2002. In addition to demographic information, use of systemic corticosteroids (hydrocortisone, methylprednisolone, or dexamethasone) concurrent with the ventilatory and vasoactive support was collected. SUBJECTS: Data from PHIS. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients (n = 6693) were identified at 27 PHIS-participating CHCA member hospitals. Overall mortality was 24%; univariate predictors of death included use of steroids (odds ratio [OR], 1.9; 95% confidence interval (CI), 1.7, 2.2), older age (e.g., 13-17 yrs vs. neonates; OR, 1.6; 95% CI, 1.3, 2.0), a hematologic-oncologic diagnosis (OR, 5.87; 95% CI, 4.19, 8.23), and moderate vs. high case volume (OR, 1.25; 95% CI, 1.09, 1.44). Age, hematologic-oncologic diagnosis, case volume, and use of steroids remained independent predictors of mortality in multivariable analysis. CONCLUSIONS: From this administrative database analysis, there is no evidence that steroids are associated with improved outcome in critically ill infants and children with sepsis. Although steroids may be given preferentially to more severely ill children, their use was associated with increased mortality. Clinicians should maintain equipoise on this topic pending prospective randomized clinical trials.

Use of a large national database for comparative evaluation of the effect of a bronchiolitis/viral pneumonia clinical care guideline on patient outcome and resource utilization.

OBJECTIVES: To use a large national comparative database to measure the internal effect of a set of evidence-based bronchiolitis/viral pneumonia clinical care guidelines on clinical practice at a children's hospital, and to compare these changes with those at other children's hospitals. DESIGN: Prospective cohort study with retrospective and concurrent (other hospital) controls. SETTING: The Children's Hospital, Denver, Colo. PARTICIPANTS: Hospitalized children with bronchiolitis and/or viral pneumonia. INTERVENTIONS: Our clinical guidelines focused on clear admission and discharge criteria, individualized transition-anticipating orders, and "prove it or don't use it" criteria for the use of respiratory syncytial virus testing, bronchodilators, chest physiotherapy, and ribavirin. MAIN OUTCOME MEASURES: The effect of guideline implementation was determined by comparative measurement of internal changes in utilization and outcome (nosocomial infection rate) across time and by external comparison with other children's hospitals using standardized data from the Pediatric Health Information System database of the Child Health Corporation of America (Shawnee Mission, Kan). RESULTS: Overall, 10 636 bronchiolitis/viral pneumonia cases were studied: 1302 at the index hospital and 9334 at the 7 comparison hospitals. Internally, the index hospital's residents and attending physicians responded favorably to the bronchiolitis/viral pneumonia care guidelines, resulting in decreases in targeted resource utilization. There were no fatalities, and the number of days in the intensive care unit decreased even though the mean severity of admitted cases increased significantly. Targeted utilization was favorably affected, whereas untargeted utilization was not. Nosocomial infections did not increase with a decreased use of respiratory syncytial virus testing. The index hospital differed favorably from other children's hospitals in several categories. CONCLUSION: Evidence-based care guidelines can successfully influence utilization and clinical outcome.