Pediatric blood & cancer
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Pediatric blood & cancer · Jul 2019
Comparative StudyUnintended consequences of evolution of the Common Terminology Criteria for Adverse Events.
Adverse events (AEs) on Children's Oncology Group (COG) trials are reported manually by clinical research assistants (CRAs). The Common Terminology Criteria for Adverse Events (CTCAE) was developed to provide standardized definitions for identifying and grading AEs. The CTCAE has expanded significantly over its five versions, but the impact of CTCAE definitional changes has not been examined. ⋯ CTCAE has increased in complexity. Although this increased complexity allows for more granular AE reporting, these data demonstrate potential unintended negative consequences of increasing CTC AE complexity, including the risk of varying approaches to AE capture. A comprehensive evaluation of CTC AE definitions and CRA reporting practices across COG institutions and AEs are needed to improve the accuracy and efficiency of AE reporting.
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Pediatric blood & cancer · May 2019
PROMIS pediatric measures validated in a longitudinal study design in pediatric oncology.
This study assessed the responsiveness to change over time and theorized associations of Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measures in children and adolescents in treatment for cancer to determine measure readiness for use in cancer clinical trials. ⋯ Most of the PROMIS pediatric measures demonstrated changes over time and had significant relationships as theorized, thus supporting concurrent and construct validity of these measures when administered to pediatric oncology patients during a course of chemotherapy. This evidence supports the measures' readiness for use in clinical trials.
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Pediatric blood & cancer · May 2019
Use of the new pediatric PROMIS measures of pain and physical experiences for children with sickle cell disease.
There are new pediatric domains to measure patients' pain and physical experiences in the Patient-Reported Outcomes Measurement Information System (PROMIS). The objective of this study was to establish the psychometric properties of these domains for children with sickle cell disease (SCD). ⋯ The new PROMIS domains of physical stress experience, strength impact, pain behavior, and pain quality sensory domains are valid and reliable for children with SCD. The low-moderate agreement between parent-proxy and child self-report scores support the complementary information provided by the two perspectives.
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Pediatric blood & cancer · Apr 2019
Randomized Controlled Trial Multicenter StudyRisk factors for chemotherapy-induced nausea in pediatric patients receiving highly emetogenic chemotherapy.
Little is known regarding risk factors for chemotherapy-induced nausea (CIN) in pediatric patients. ⋯ Acute phase CIN was associated with nonwhite race. Delayed phase CIN was associated with poor acute phase CIN control, diagnosis of non-CNS cancer, and receipt of cisplatin. These findings will inform future antiemetic trial design.
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Pediatric blood & cancer · Mar 2019
Pediatric pain screening identifies youth at risk of chronic pain in sickle cell disease.
This study aimed to evaluate the preliminary validation and application of a pain screening tool to identify biopsychosocial risk factors for chronic pain in pediatric sickle cell disease (SCD) and classify youth with SCD into prognostic risk groups. ⋯ The high-risk group demonstrated a pain and psychosocial profile consistent with chronic SCD pain. The PPST may be useful for efficiently identifying youth with chronic SCD pain or those at risk of poor outcomes.