Related Experiment Video
Updated: Jan 19, 2026
A Computer-Based Platform for Aiding Clinicians in Eating Disorder Analysis and Diagnosis
Published on: May 10, 2022
Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve
Molly McFatrich1, Jennifer Brondon2, Nicole R Lucas1
1Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.
Insights
A new algorithm accurately translates pediatric patient symptom reports into standardized cancer trial toxicity grades. This improves adverse event reporting for children in oncology studies.
Area of Science:
- Oncology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- Clinician reporting of symptomatic adverse events (AEs) in oncology trials is subjective.
- A pediatric patient-reported outcome (PRO) instrument, Pediatric PRO-CTCAE, was developed to capture symptomatic AEs.
- Standardizing AE reporting in pediatric oncology is crucial for accurate toxicity grading.
Purpose of the Study:
- To develop a standardized algorithm mapping Pediatric PRO-CTCAE responses to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) grades.
- To enhance the accuracy of AE reporting in pediatric oncology clinical trials.
- To integrate child self-reported symptom data into AE reporting frameworks.
Main Methods:
- Two rounds of surveys administered to experienced cancer clinicians across 9 pediatric hospitals.
- Round 1: Pediatric oncologists assigned CTCAE grades to 101 Pediatric PRO-CTCAE response patterns.
- Round 2: A larger clinician group examined agreement on select patterns and the influence of clinical context.
Main Results:
- High clinician agreement (88%) was achieved for 89 out of 101 response patterns in Round 1 (Light kappa = 0.73).
- Round 2 confirmed high agreement for most patterns, with clinical context improving, not altering, grade assignments.
- The developed algorithm demonstrates strong reliability for translating patient-reported symptoms into standardized toxicity grades.
Conclusions:
- A framework for integrating child self-reported symptom data into AE reporting in oncology trials was established.
- Translating Pediatric PRO-CTCAE responses into clinically meaningful metrics is essential for future cancer care.
- This approach will guide toxicity grading and improve the quality of AE reporting in pediatric oncology.
Background:
Clinicians are the standard source for adverse event (AE) reporting in oncology trials, despite the subjective nature of symptomatic AEs. The authors designed a pediatric patient-reported outcome (PRO) instrument for symptomatic AEs to support the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) (the Pediatric PRO-CTCAE). The current study developed a standardized algorithm that maps all possible Pediatric PRO-CTCAE response patterns to recommended CTCAE grades to improve the accuracy of AE reporting in pediatric oncology trials.
Methods:
Two rounds of surveys were administered to experienced cancer clinicians across 9 pediatric hospitals. In round 1, pediatric oncologists assigned CTCAE grades to all 101 possible Pediatric PRO-CTCAE response patterns. The authors evaluated clinician agreement of CTCAE grades across response patterns and categorized each response pattern as having high or low agreement. In round 2, a survey was sent to a larger clinician group to examine clinician agreement among a select set of Pediatric PRO-CTCAE response patterns, and the authors examined how clinical context influenced grade assignment.
Results:
A total of 10 pediatric oncologists participated in round 1. Of the 101 possible patterns, 89 (88%) had high agreement. The Light weighted kappa was averaged across the 10 oncologists (Light kappa = 0.73; 95% CI, 0.66-0.81). A total of 139 clinicians participated in round 2. High clinician agreement remained for the majority of generic response patterns and the clinical context did not typically change grades but rather improved agreement.
Conclusions:
The current study provides a framework for integrating child self-reported symptom data directly into mandated AE reporting in oncology trials. Translating Pediatric PRO-CTCAE responses into clinically meaningful metrics will guide future cancer care and toxicity grading.
More Related Videos
05:48The Adventures of Fundi Intervention Based on the Cognitive and Emotional Processing in Attention Deficit Hyperactive Disorder Patients
Published on: June 12, 2020
08:25Polar Histogram Visualization of Acute Stress Disorder Scale Scores for Comprehensive Clinical Assessment
Published on: December 6, 2024
Related Concept Videos
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:21Cancer Survival Analysis
01:17Assessment of the Gastrointestinal System I: Subjective Data
Health History
The initial step in assessing the GI system is obtaining a comprehensive health history. This includes inquiring about the patient's history or presence of problems...