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Predicting risk factors for pediatric mortality in clinical trial research: A retrospective, cross-sectional study
Jiahui Ma1, Elizabeth A Johnson2, Bernadette McCrory1
1Montana State University, Norm Asbjornson College of Engineering, Bozeman, MT, USA.
Insights
Real-world data analysis of pediatric clinical trials reveals factors influencing survival. Key associations include diagnoses, procedures, hospital transfer, specific conditions, and hospital size, informing patient safety improvements.
Area of Science:
- Pediatric clinical trial research
- Healthcare data analytics
- Patient safety in clinical trials
Background:
- Real-world data and big data analysis are crucial for improving healthcare delivery.
- All-cause mortality is a key metric for enhancing patient safety in clinical trials, particularly for pediatric participants.
Purpose of the Study:
- To determine associations between pediatric mortality and patient-specific factors.
- Utilize the Healthcare Cost and Utilization Project (HCUP) database for analysis.
Main Methods:
- Logistic regression analysis of the 2019 HCUP Kids' Inpatient Database (KID).
- Examined associations between pediatric survival and demographic, socioeconomic, discharge, and hospital factors.
Main Results:
- Survival associated with fewer diagnoses/procedures, longer stays, older age, and hospital transfers.
- Conditions like major trauma or hepatobiliary issues significantly decreased survival odds.
- West/Midwest regions and larger hospitals showed associations with survival.
Conclusions:
- Real-world data analysis identifies areas for improving pediatric clinical trial quality and safety.
- User-centered design is needed for pediatric trial tools.
- Safe transfer procedures and best practice dissemination are vital for trial management and safety.
Introduction:
Incorporating real-world data using "big data" analysis in healthcare are useful to extract specific information for healthcare delivery system improvement. All-cause mortality is an essential measure to enhance patient safety in clinical trial research, especially for underrepresented pediatric participants.
Objective:
This study aimed to determine the associations between pediatric mortality and patient-specific factors using the Healthcare Cost and Utilization Project (HCUP) database.
Methods:
Data from the 2019 the HCUP Kids' Inpatient Database (KID) were used to conduct a logistic regression analysis to determine associations between pediatric patients' the chance of survival and their demographic and socioeconomic background, discharge records, and hospital information.
Results:
Total number of diagnoses (OR = 0.84), total number of procedures (OR = 0.86), length of stay (OR = 1.04), age intervals greater than 1 year (OR > 1.0), transfer into the hospital from a different acute care (OR = 0.34), major diagnoses of multiple significant trauma (OR = 0.03) or hepatobiliary system and pancreas (OR = 0.10), region of hospital - west and midwest (OR > 1.0), and medium or larger hospital bed size (OR > 1.0) were all significantly associated with the chance of survival for patients participating in pediatric clinical trials (p < 0.05).
Conclusion:
Real-world clinical trial data analysis showed the potential improvement area including reallocating trial resources to promote trial quality and safe participation for pediatric patients. Pediatric trials need tools that are developed using user-centered design approaches to satisfy the unique needs and requirements of pediatric patients and their caregivers. Safe intrahospital transfer procedures and active dissemination of successful trial best practices are crucial to trial management, adherence, quality, and safety.
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