First name
Yuan-Shun
Last name
Huang
Suffix
V

Title

Center-level variation in accuracy of adverse event reporting in a clinical trial for pediatric acute myeloid leukemia: A report from the Children's Oncology Group.

Year of Publication

2017

Date Published

2017 Jun 22

ISSN Number

1592-8721

DOI

10.3324/haematol.2017.168815

Alternate Title

Haematologica

PMID

28642300

Title

A comparison of discharge strategies after chemotherapy completion in pediatric patients with acute myeloid leukemia: a report from the Children's Oncology Group.

Year of Publication

2016

Number of Pages

1-8

Date Published

2016 Jan 4

ISSN Number

1029-2403

Abstract

<p>While most children receive acute myeloid leukemia (AML) chemotherapy as inpatients, there is variability in timing of discharge after chemotherapy completion. This study compared treatment-related morbidity, mortality and cumulative hospitalization in children with AML who were discharged after chemotherapy completion (early discharge) and those who remained hospitalized. Chart abstraction data for 153 early discharge-eligible patients enrolled on a Children's Oncology Group trial were compared by discharge strategy. Targeted toxicities included viridans group streptococcal (VGS) bacteremia, hypoxia and hypotension. Early discharge occurred in 11% of courses post-Induction I. Re-admission occurred in 80-100%, but median hospital stay was 7 days shorter. Patients discharged early had higher rates of VGS (adjusted risk ratio (aRR) = 1.67, 95% CI = 1.11-2.51), hypoxia (aRR = 1.92, 95% CI = 1.06-3.48) and hypotension (aRR = 4.36, 95% CI = 2.01-9.46), but there was no difference in mortality. As pressure increases to shorten hospitalizations, these results have important implications for determining discharge practices in pediatric AML.</p>

DOI

10.3109/10428194.2015.1088652

Alternate Title

Leuk. Lymphoma

PMID

26727639

Title

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia.

Year of Publication

2016

Date Published

2016 Feb 16

ISSN Number

1527-7755

Abstract

<p><strong>PURPOSE: </strong>Reporting of adverse events (AEs) in clinical trials is critical to understanding treatment safety, but data on AE accuracy are limited. This study sought to determine the accuracy of AE reporting for pediatric acute myeloid leukemia clinical trials and to test whether an external electronic data source can improve reporting.</p>

<p><strong>METHODS: </strong>Reported AEs were evaluated on two trials, Children's Oncology Group AAML03P1 and AAML0531 arm B, with identical chemotherapy regimens but with different toxicity reporting requirements. Chart review for 12 AEs for patients enrolled in AAML0531 at 14 hospitals was the gold standard. The sensitivity and positive predictive values (PPV) of the AAML0531 AE report and AEs detected by review of Pediatric Health Information System (PHIS) billing and microbiology data were compared with chart data.</p>

<p><strong>RESULTS: </strong>Select AE rates from AAML03P1 and AAML0531 arm B differed significantly and correlated with the targeted toxicities of each trial. Chart abstraction was performed on 204 patients (758 courses) on AAML0531. AE report sensitivity was &lt; 50% for eight AEs, but PPV was &gt; 75% for six AEs. AE reports for viridans group streptococcal bacteremia, a targeted toxicity on AAML0531, had a sensitivity of 78.3% and PPV of 98.1%. PHIS billing data had higher sensitivity (&gt; 50% for nine AEs), but lower PPV (&lt; 75% for 10 AEs). Viridans group streptococcal detection using PHIS microbiology data had high sensitivity (92.3%) and PPV (97.3%).</p>

<p><strong>CONCLUSION: </strong>The current system of AE reporting for cooperative oncology group clinical trials in pediatric acute myeloid leukemia underestimates AE rates. The high sensitivity and PPV of PHIS microbiology data suggest that using external data sources may improve the accuracy of AE reporting.</p>

DOI

10.1200/JCO.2015.65.5860

Alternate Title

J. Clin. Oncol.

PMID

26884558

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