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Pediatric reference intervals in China (PRINCE): design and rationale for a large, multicenter collaborative
Xin Ni1, Wenqi Song1, Xiaoxia Peng1
1Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China.
Insights
Establishing accurate pediatric reference intervals (RIs) in China is crucial. The PRINCE project addresses this by creating age- and gender-specific RIs for 31 common lab tests in children up to 19 years old.
Area of Science:
- Clinical Chemistry
- Pediatric Laboratory Medicine
- Reference Interval Establishment
Background:
- Current pediatric reference intervals (RIs) in China lack accuracy and do not account for age and gender variations.
- Existing RIs are often based on outdated or inappropriate methodologies, impacting clinical decision-making for children.
Purpose of the Study:
- To establish and validate accurate, age- and gender-specific pediatric reference intervals (RIs) for 31 common laboratory measurands in China.
- To address the critical need for reliable RIs in Chinese pediatric healthcare.
Main Methods:
- A large-scale, multicenter, cross-sectional study involving 14,490 healthy children and adolescents up to 19 years old.
- Data collection across 10 children's hospitals and one university pediatric department.
- A pilot study of 602 children was conducted to refine methodology and assess feasibility.
Main Results:
- The pilot study revealed significant age-dependency and gender-based differences in certain laboratory measurands.
- Feasibility challenges were identified, including recruitment of very young children and infant blood sample collection.
- The pilot results confirmed the necessity of the PRINCE project.
Conclusions:
- The PRINCE project is essential for developing reliable pediatric RIs in China.
- Methodological adjustments based on pilot findings are crucial for the study's validity and transparency.
- Accurate RIs will improve diagnosis and treatment for pediatric patients in China.
Abstract:
There is a lack of accurate pediatric reference intervals (RIs) in China, with most commonly used RIs established without consideration of the effect of age and gender. The Pediatric Reference Intervals in China (PRINCE) project aims to establish and verify pediatric RIs for 31 common laboratory measurands. The project will be a large, multicenter cross-sectional study: 14,490 healthy children and adolescents aged up to 19 years will be surveyed by 10 children's hospitals and one pediatric department of a university hospital. To evaluate the feasibility and efficiency of the study methods, 602 children were surveyed in the pilot phase of the PRINCE study in April 2017: it found that some measurands were distinctly age dependent and that there were differences between values for males and females. The results of the pilot study affirmed the necessity of the PRINCE project for Chinese pediatrics. The pilot also indicated potential difficulties in the full survey, e.g., difficulties in recruiting children aged under 3 years and insufficient collection of blood samples from infants. The operation of the PRINCE project has been modified based on the findings in the pilot study toward improving the validity of the PRINCE project and promoting its openness and transparency.
