title: Early discharge as a mediator of greater ICU-level care requirements in patients not enrolled on the AAML0531 clinical trial: a Children's Oncology Group report.
abstract: Previous data suggest that patients enrolled on clinical trials for treatment of cancer have better overall survival than patients who do not enroll; however, short-term outcomes relative to trial enrollment and corresponding mediators have not been assessed. A cohort of pediatric patients with newly-diagnosed acute myeloid leukemia was assembled from the Pediatric Health Information System. We evaluated whether patients not enrolled onto Children's Oncology Group trial AAML0531 had greater intensive care unit (ICU)-level requirements than enrolled patients and whether early discharge after chemotherapy administration mediated this association. Patients not enrolled on AAML0531 were more likely to be discharged early (aOR = 1.40, 95% confidence interval [CI]: 1.02, 1.90) and to require ICU-level care (aOR = 2.00, 95% CI: 1.06, 3.78) than enrolled patients, but early discharge explained only a small proportion (12.3%) of the absolute difference in ICU-level care risk. The direct effect of nonenrollment on the need for ICU-level care was significant (aOR = 1.89, 95% CI: 1.00, 3.94), whereas the indirect effect mediated through early discharge was not (aOR = 1.07, 95% CI: 0.95, 1.19). Factors other than postchemotherapy discharge strategy drive the difference in ICU utilization by trial enrollment status.
authors.affiliation: The Children's Hospital of Philadelphia, 3535 Market Street, Philadelphia, Pennsylvania, 19104. getzk@email.chop.edu.
authors.forename: Kelly D
authors.initials: KD
authors.lastname: Getz
authors.affiliation: The Children's Hospital of Philadelphia, 3501 Civic Center Boulevard, Philadelphia, Pennsylvania, 19104.
authors.forename: Tamara P
authors.initials: TP
authors.lastname: Miller
authors.affiliation: The Children's Hospital of Philadelphia, 3501 Civic Center Boulevard, Philadelphia, Pennsylvania, 19104.
authors.forename: Alix E
authors.initials: AE
authors.lastname: Seif
authors.affiliation: The Children's Hospital of Philadelphia, 3501 Civic Center Boulevard, Philadelphia, Pennsylvania, 19104.
authors.forename: Yimei
authors.initials: Y
authors.lastname: Li
authors.affiliation: The Children's Hospital of Philadelphia, 3535 Market Street, Philadelphia, Pennsylvania, 19104.
authors.forename: Yuan-Shung
authors.initials: YS
authors.lastname: Huang
authors.affiliation: University of Southern California, Children's Oncology Group, 222 E. Huntington Drive, Monrovia, California, 91016.
authors.forename: Todd
authors.initials: T
authors.lastname: Alonzo
authors.affiliation: Children's Oncology Group, 222 E. Huntington Drive, Monrovia, California, 91016.
authors.forename: Robert
authors.initials: R
authors.lastname: Gerbing
authors.affiliation: The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, Canada.
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
authors.affiliation: Children's Hospital Association, 6803 W. 64th Street, Overland Park, Kansas, 66202.|Children's Mercy Hospitals and Clinics, 2401 Gillham Road, Kansas City, Missouri, 64108.
authors.forename: Matthew
authors.initials: M
authors.lastname: Hall
authors.affiliation: The Children's Hospital of Philadelphia, 3535 Market Street, Philadelphia, Pennsylvania, 19104.
authors.forename: Rochelle
authors.initials: R
authors.lastname: Bagatell
authors.affiliation: Children's Mercy Hospitals and Clinics, 2401 Gillham Road, Kansas City, Missouri, 64108.
authors.forename: Alan
authors.initials: A
authors.lastname: Gamis
authors.affiliation: The Children's Hospital of Philadelphia, 3535 Market Street, Philadelphia, Pennsylvania, 19104.
authors.forename: Brian T
authors.initials: BT
authors.lastname: Fisher
authors.affiliation: The Children's Hospital of Philadelphia, 3501 Civic Center Boulevard, Philadelphia, Pennsylvania, 19104.
authors.forename: Richard
authors.initials: R
authors.lastname: Aplenc
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003422:Critical Care; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015278:Intensive Care Units, Pediatric; D015470:Leukemia, Myeloid, Acute / Q000453:epidemiology / Q000628:therapy; D008297:Male; D010342:Patient Acceptance of Health Care; D010351:Patient Discharge; D016896:Treatment Outcome
keywords: Acute myeloid leukemia; disparities; mediation; patient discharge; pediatrics; trial enrollment