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Comparison of four algorithms on establishing continuous reference intervals for pediatric analytes with age-dependent trend.

ABSTRACT: BACKGROUND:Continuous reference intervals (RIs) allow for more precise consideration of the dynamic changes of physiological development, which can provide new strategies for the presentation of laboratory test results. Our study aimed to establish continuous RIs using four different simulation methods so that the applicability of different methods could be further understood. METHODS:The data of alkaline phosphatase (ALP) and serum creatinine (Cr) were obtained from the Pediatric Reference Interval in China study (PRINCE), in which healthy children aged 0-19?years were recruited. The improved non-parametric method, the radial smoothing method, the General Additive Model for Location Scale and Shape (GAMLSS), and Lambda-Median-Sigma (LMS) were used to develop continuous RIs. The accuracy and goodness of fit of the continuous RIs were evaluated based on the out of range (OOR) and Akaike Information Criterion (AIC) results. RESULTS:Samples from 11,517 and 11,544 participants were used to estimate the continuous RIs of ALP and Cr, respectively. Time frames were partitioned to fulfill the following two criteria: sample size?=?120 in each subgroup and mean difference?=?2 between adjacent time frames. Cubic spline or penalized spline was used for curve smoothing. The RIs estimated by the four methods approximately overlapped. However, more obvious edge effects were shown in the curves fit by the non-parametric methods than the semi-parametric method, which may be attributed to insufficient sample size. The OOR values of all four methods were smaller than 10%. CONCLUSIONS:All four methods could be used to establish continuous RIs. GAMLSS and LMS are more reliable than the other two methods for dealing with edge effects.

SUBMITTER: Li K

PROVIDER: S-EPMC7268336 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Comparison of four algorithms on establishing continuous reference intervals for pediatric analytes with age-dependent trend.

Li Kun K Hu Lixin L Peng Yaguang Y Yan Ruohua R Li Qiliang Q Peng Xiaoxia X Song Wenqi W Ni Xin X

BMC medical research methodology 20200601 1

<h4>Background</h4>Continuous reference intervals (RIs) allow for more precise consideration of the dynamic changes of physiological development, which can provide new strategies for the presentation of laboratory test results. Our study aimed to establish continuous RIs using four different simulation methods so that the applicability of different methods could be further understood.<h4>Methods</h4>The data of alkaline phosphatase (ALP) and serum creatinine (Cr) were obtained from the Pediatric ...[more]

PMID: 32487062

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Project description:BackgroundReference intervals are assessment tools for interpretation of clinical test results. These intervals describe the dispersion of test parameter values of apparently healthy persons in defined populations as health status indicators. Using reference intervals obtained and validated in populations outside the geographical region of derivation for medical decision-making may impact negatively on clinical interpretation and patient management. Many countries have established their reference values, current studies on these data for Nigeria are however scarce. Determination of clinical biochemistry reference intervals for young Nigerian adults which is of particular importance in routine clinical management and conduct of clinical trials in response to existing and emerging diseases will add significantly to the existing body of knowledge.ObjectiveThe objective was to establish reference intervals for 24biochemistry analytes among Nigerians aged 18 to 26 years.MethodsThis was a cross-sectional study among 7,797 consenting male and female military applicants aged 18 to 26 years from 37 States of Nigeria. It was a total study among volunteers for military service. Blood samples were collected and subjected to serological testing for HIV-1 and 2, hepatitis-B, malaria, pregnancy and haematuria to restrict our study population to apparently healthy participants. Biochemical assays were performed on 6,169 participant samples that met the inclusion criteria. Generated data was entered into MS Excel® and exported into SPSS® software version 16 for analysis. Statistical tools used were frequencies, median, mid 95th percentile range with 2.5th and 97.5th percentiles as limits. Reference intervals were estimated using nonparametric methods. No intergender statistical comparison was made.ResultsComplete records were obtained for 6,169 eligible participants. Median values and associated reference intervals were similar in both genders.ConclusionThe findings from this study will help in clinical decision-making and play a significant role in supporting the current global rapid expansion of clinical trials in response to the urgent need for preventive and therapeutic solutions to existing and emerging diseases.

Dataset Information

Comparison of four algorithms on establishing continuous reference intervals for pediatric analytes with age-dependent trend.

Publications

Comparison of four algorithms on establishing continuous reference intervals for pediatric analytes with age-dependent trend.

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