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1.  Postinduction Dexamethasone and Individualized Dosing of Escherichia Coli L-Asparaginase Each Improve Outcome of Children and Adolescents With Newly Diagnosed Acute Lymphoblastic Leukemia: Results From a Randomized Study—Dana-Farber Cancer Institute ALL Consortium Protocol 00-01 
Journal of Clinical Oncology  2013;31(9):1202-1210.
Purpose
We assessed the toxicity and efficacy of dexamethasone and a novel dosing method of Escherichia coli L-asparaginase (EC-Asnase) in children and adolescents with newly diagnosed acute lymphoblastic leukemia (ALL).
Patients and Methods
Patients achieving complete remission (CR) on Dana-Farber Cancer Institute ALL Consortium Protocol 00-01 were eligible for random assignment to 1) dexamethasone or prednisone, administered as 5-day pulses, every 3 weeks, and 2) weekly EC-Asnase, administered as a 25,000 IU/m2 fixed dose (FD) or individualized dose (ID) starting at 12,500-IU/m2, adjusted every 3 weeks based on nadir serum asparaginase activity (NSAA) determinations.
Results
Between 2000 and 2004, 492 evaluable patients (ages 1 to 18 years) enrolled; 473 patients (96%) achieved CR. Four hundred eight patients (86%) participated in the corticosteroid randomization and 384 patients (81%) in the EC-Asnase randomization. With 4.9 years of median follow-up, dexamethasone was associated with superior 5-year event-free survival (EFS; 90% v 81% for prednisone; P = .01) but higher rates of infection (P = .03) and, in older children, higher cumulative incidence of osteonecrosis (P = .02) and fracture (P = .06). ID EC-Asnase had superior 5-year EFS (90% v 82% for FD; P = .04), but did not reduce the frequency of asparaginase-related toxicity. Multivariable analysis identified both dexamethasone and ID EC-Asnase as independent predictors of favorable EFS.
Conclusion
There was no overall difference in skeletal toxicity by corticosteroid type; dexamethasone was associated with more infections and, in older children, increased incidence of osteonecrosis and fracture. There was no difference in asparaginase-related toxicity by EC-Asnase dosing method. Dexamethasone and ID EC-Asnase were each associated with superior EFS. Monitoring NSAA during treatment with EC-Asnase may be an effective strategy to improve outcome in pediatric ALL.
doi:10.1200/JCO.2012.43.2070
PMCID: PMC3595424  PMID: 23358966
2.  Predictors of Clinical Outcomes and Hospital Resource Use of Children After Tracheotomy 
Pediatrics  2009;124(2):563-572.
OBJECTIVES
The objectives are to describe health outcomes and hospital resource use of children after tracheotomy and identify patient characteristics that correlate with outcomes and hospital resource use.
PATIENTS AND METHODS
A retrospective analysis of 917 children aged 0 to 18 years undergoing tracheotomy from 36 children’s hospitals in 2002 with follow-up through 2007. Children were identified from ICD-9-CM tracheotomy procedure codes. Comorbid conditions (neurologic impairment [NI], chronic lung disease, upper airway anomaly, prematurity, and trauma) were identified with ICD-9-CM diagnostic codes. Patient characteristics were compared with in-hospital mortality, decannulation, and hospital resource use by using generalized estimating equations.
RESULTS
Forty-eight percent of children were ≤6 months old at tracheotomy placement. Chronic lung disease (56%), NI (48%), and upper airway anomaly (47%) were the most common underlying comorbid conditions. During hospitalization for tracheotomy placement, children with an upper airway anomaly experienced less mortality (3.3% vs 11.7%; P < .001) than children without an upper airway anomaly. Five years after tracheotomy, children with NI experienced greater mortality (8.8% vs 3.5%; P≤.01), less decannulation (5.0% vs 11.0%; P≤.01), and more total number of days in the hospital (mean [SE]: 39.5 [4.0] vs 25.6 [2.6] days; P≤.01) than children without NI. These findings remained significant (P < .01) in multivariate analysis after controlling for other significant cofactors.
CONCLUSIONS
Children with upper airway anomaly experienced less mortality, and children with NI experienced higher mortality rates and greater hospital resource use after tracheotomy. Additional research is needed to explore additional factors that may influence health outcomes in children with tracheotomy.
doi:10.1542/peds.2008-3491
PMCID: PMC3614342  PMID: 19596736
tracheotomy; children; mortality; hospitalization; health services; outcomes
3.  The occupational and quality of life consequences of chronic fatigue syndrome/myalgic encephalomyelitis in young people 
Introduction
Chronic fatigue syndrome, termed myalgic encephalomyelitis in the United Kingdom (CFS/ME), is a debilitating condition involving severe exhaustion, cognitive difficulties, educational and vocational losses, and disruption of social activities and relationships. CFS/ME may affect volition (that is, value, interest and sense of competence).
Purpose
To test Model of Human Occupation (MOHO) concepts by comparing young people with and without CFS/ME in terms of occupational participation, volition and health-related quality of life during infection and over time.
Method
Three hundred and one people (12–18 years old) diagnosed with glandular fever were evaluated at the time of acute infection (baseline). Six months following diagnosis, 39 of them met the criteria for CFS/ME. A further 39 who recovered were randomly selected and matched to CFS/ME participants. Both groups were re-evaluated at 12 months and 24 months. The Occupational Self Assessment and the Child General Health Questionnaire were used to compare occupational participation.
Results
Those with CFS/ME reported lower levels of perceived competency, more difficulties with physical functioning and poorer general health status than those who recovered.
Conclusion
Those with CFS/ME report lower perceived competency, and compromises in physical functioning, school performance, social activities, emotional functioning and general health. This supports the MOHO assertion that impairments affect volition and quality of life.
doi:10.4276/030802210X12892992239233
PMCID: PMC3217273  PMID: 22102767
4.  Patient characteristics associated with in-hospital mortality in children following tracheotomy 
Archives of disease in childhood  2010;95(9):703-710.
Objectives
To identify children at risk for in-hospital mortality following tracheotomy.
Design
Retrospective cohort study.
Setting
25 746 876 US hospitalisations for children within the Kids’ Inpatient Database 1997, 2000, 2003 and 2006.
Participants
18 806 hospitalisations of children ages 0–18 years undergoing tracheotomy, identified from ICD-9-CM tracheotomy procedure codes.
Main outcome measure
Mortality during the initial hospitalisation when tracheotomy was performed in relation to patient demographic and clinical characteristics (neuromuscular impairment (NI), chronic lung disease, upper airway anomaly, prematurity, congenital heart disease, upper airway infection and trauma) identified with ICD-9-CM codes.
Results
Between 1997 and 2006, mortality following tracheotomy ranged from 7.7% to 8.5%. In each year, higher mortality was observed in children undergoing tracheotomy who were aged <1 year compared with children aged 1–4 years (mortality range: 10.2–13.1% vs 1.1–4.2%); in children with congenital heart disease, compared with children without congenital heart disease (13.1–18.7% vs 6.2–7.1%) and in children with prematurity, compared with children who were not premature (13.0–19.4% vs 6.8–7.3%). Lower mortality was observed in children with an upper airway anomaly compared with children without an upper airway anomaly (1.5–5.1% vs 9.1–10.3%). In 2006, the highest mortality (40.0%) was observed in premature children with NI and congenital heart disease, who did not have an upper airway anomaly.
Conclusions
Congenital heart disease, prematurity, the absence of an upper airway anomaly and age <1 year were characteristics associated with higher mortality in children following tracheotomy. These findings may assist provider communication with children and families regarding early prognosis following tracheotomy.
doi:10.1136/adc.2009.180836
PMCID: PMC3118570  PMID: 20522454
5.  Health information management and perceptions of the quality of care for children with tracheotomy: A qualitative study 
Background
Children with tracheotomy receive health care from an array of providers within various hospital and community health system sectors. Previous studies have highlighted substandard health information exchange between families and these sectors. The aim of this study was to investigate the perceptions and experiences of parents and providers with regard to health information management, care plan development and coordination for children with tracheotomy, and strategies to improve health information management for these children.
Methods
Individual and group interviews were performed with eight parents and fifteen healthcare (primary and specialty care, nursing, therapist, equipment) providers of children with tracheotomy. The primary tracheotomy-associated diagnoses for the children were neuromuscular impairment (n = 3), airway anomaly (n = 2) and chronic lung disease (n = 3). Two independent reviewers conducted deep reading and line-by-line coding of all transcribed interviews to discover themes associated with the objectives.
Results
Children with tracheotomy in this study had healthcare providers with poorly defined roles and responsibilities who did not actively communicate with one another. Providers were often unsure where to find documentation relating to a child's tracheotomy equipment settings and home nursing orders, and perceived that these situations contributed to medical errors and delayed equipment needs. Parents created a home record that was shared with multiple providers to track the care that their children received but many considered this a burden better suited to providers. Providers benefited from the parent records, but questioned their accuracy regarding critical tracheotomy care plan information such as ventilator settings. Parents and providers endorsed potential improvement in this environment such as a comprehensive internet-based health record that could be shared among parents and providers, and between various clinical sites.
Conclusions
Participants described disorganized tracheotomy care and health information mismanagement that could help guide future investigations into the impact of improved health information systems for children with tracheotomy. Strategies with the potential to improve tracheotomy care delivery could include defined roles and responsibilities for tracheotomy providers, and improved organization and parent support for maintenance of home-based tracheotomy records with web-based software applications, personal health record platforms and health record data authentication techniques.
doi:10.1186/1472-6963-11-117
PMCID: PMC3127978  PMID: 21605385
6.  Long-term results of Dana-Farber Cancer Institute ALL Consortium protocols for children with newly diagnosed acute lymphoblastic leukemia (1985–2000) 
The Dana-Farber Cancer Institute (DFCI) ALL Consortium has been conducting multi-institutional clinical trials in childhood ALL since 1981. The treatment backbone has included 20–30 consecutive weeks of asparaginase during intensification and frequent vincristine/corticosteroid pulses during the continuation phase. Between 1985–2000, 1457 children aged 0–18 years were treated on four consecutive protocols: 85-01 (1985–7), 87-01 (1987–91), 91-01 (1991–5) and 95-01 (1996–2000). The 10-year event-free survival (EFS) ± standard error by protocol was 77.9 ± 2.8% (85-01), 74.2± 2.3 (87-01), 80.8 ± 2.1% (91-01) and 80.5 ± 1.8% (95-01). Approximately 82% of patients treated in the 1980s and 88% treated in the 1990s were long-term survivors. Both EFS and overall survival (OS) rates were significantly higher for patients treated in the 1990s compared with the 1980s (p=0.05 and 0.01, respectively). On the two protocols conducted in the 1990s, EFS was 79–85% for T-ALL patients and 75–78% for adolescents (age 10–18 years). Results of randomized studies revealed that dexrazoxane prevented acute cardiac injury without adversely impacting EFS or OS in high-risk patients and frequently-dosed intrathecal chemotherapy was an effective substitute for cranial radiation in standard-risk patients. Current studies continue to focus on improving efficacy while minimizing acute and late toxicities.
doi:10.1038/leu.2009.253
PMCID: PMC2820141  PMID: 20016537
Acute lymphoblastic leukemia; long-term follow-up; asparaginase; anthracycline

Results 1-6 (6)