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Establishment of Reference Interval and Aging Model of Homocysteine Using Real-World Data
Chaochao Ma1, Lei Li1, Xinlu Wang2
1Department of Laboratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
Insights
Homocysteine (Hcy) reference intervals require sex-specific adjustments. This study developed sex- and age-specific Hcy models, offering personalized clinical decision-making tools for Hcy levels.
Area of Science:
- Clinical Biochemistry
- Data Mining
- Biostatistics
Background:
- Homocysteine (Hcy) levels typically differ between males and females, yet a single reference interval (RI) is commonly applied.
- Establishing precise RIs is crucial for accurate clinical interpretation of Hcy concentrations.
Purpose of the Study:
- To establish sex-specific reference intervals (RIs) for Homocysteine (Hcy) using five data mining algorithms.
- To develop an age-related continuous RI for Hcy to reflect age-associated concentration changes.
- To compare the RIs generated by different data mining algorithms.
Main Methods:
- Analysis of 20,801 individuals' data.
- Outlier identification using the Tukey method.
- Determination of sex and age partitioning necessity via multiple linear regression and Standard Deviation Ratio (SDR).
- Application of Hoffmann, Bhattacharya, Expectation Maximization (EM), kosmic, and refineR algorithms for RI establishment.
- Utilizing Generalized Additive Models for Location Scale and Shape (GAMLSS) for age-related continuous RI calculation.
Main Results:
- The Standard Deviation Ratio (SDR = 0.735) indicated a necessary partition of Hcy RI by sex.
- RIs derived from Hoffmann, Bhattacharya, EM (females), and kosmic algorithms demonstrated consistency with refineR's 95% confidence interval.
- The sex-specific aging model revealed that Hcy upper RI limits decrease from age 18, rise after 40 in females, and consistently increase with age in males.
Conclusions:
- Homocysteine (Hcy) reference intervals must be sex-specific.
- The five data mining algorithms yielded consistent Hcy RIs.
- A dynamic, sex- and age-specific Hcy model provides personalized clinical decision support.
Objective:
The level of Homocysteine (Hcy) in males is generally higher than that of females, but the same reference interval (RI) is often used in clinical practice. This study aims to establish a sex-specific RI of Hcy using five data mining algorithms and compare these results. Furthermore, age-related continuous RI was established in order to show the relationship between Hcy concentration distribution and age.
Methods:
A total of 20,801 individuals were included in the study and Tukey method was used to identify outliers in subgroups by sex and age. Multiple linear regression and standard deviation ratio (SDR) was used to determine whether the RI for Hcy needs to be divided by sex and age. Five algorithms including Hoffmann, Bhattacharya, expectation maximization (EM), kosmic and refineR were utilized to establish the RI of Hcy. Generalized Additive Models for Location Scale and Shape (GAMLSS) algorithm was used to determine the aging model of Hcy and calculate the age-related continuous RI.
Results:
RI of Hcy needed to be partitioned by sex (SDR = 0.735 > 0.375). RIs established by Hoffmann, Bhattacharya, EM (for females) and kosmic are all within the 95% CI of reference limits established by refine R. The Sex-specific aging model of Hcy showed that the upper limits of the RI of Hcy declined with age beginning at age of 18 and began to rise approximately after age of 40 for females and increased with age for males.
Conclusion:
The RI of Hcy needs to be partitioned by sex. The RIs established by the five data mining algorithms showed good consistency. The dynamic sex and age-specific model of Hcy showed the pattern of Hcy concentration with age and provide more personalized tools for clinical decisions.
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