Dataset Information

Current State of Pediatric Reference Intervals and the Importance of Correctly Describing the Biochemistry of Child Development: A Review.

ABSTRACT:

Importance

Appropriately established pediatric reference intervals are critical to the clinical decision-making process and should reflect the physiologic changes that occur during healthy child development. Reference intervals used in pediatric care today remain highly inconsistent across a broad range of common clinical biomarkers.

Observations

This narrative review assesses biomarker-specific pediatric reference intervals and their clinical utility with respect to the underlying biological changes occurring during development. Pediatric reference intervals from PubMed-indexed articles published from January 2015 to April 2021, commercial laboratory websites, study cohorts, and pediatric reference interval books were all examined. Although large numbers of pediatric reference intervals are published for some biomarkers, very few are used by clinical and commercial laboratories. The patterns, extent, and timing of biomarker changes are highly variable, particularly during developmental stages with rapid physiologic changes. However, many pediatric reference intervals do not capture these changes and thus do not accurately reflect the underlying biochemistry of development, resulting in significant inconsistencies between reference intervals.

Conclusions and relevance

There is a need to correctly describe the biochemistry of child development as well as to identify strategies to develop accurate and consistent pediatric reference intervals for improved pediatric care.

SUBMITTER: Lyle AN

PROVIDER: S-EPMC10155856 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Publications

Current State of Pediatric Reference Intervals and the Importance of Correctly Describing the Biochemistry of Child Development: A Review.

Lyle Alicia N AN Pokuah Fidelia F Dietzen Dennis J DJ Wong Edward C C ECC Pyle-Eilola Amy L AL Fuqua John S JS Woodworth Alison A Jones Patricia M PM Akinbami Lara J LJ Garibaldi Luigi R LR Vesper Hubert W HW

JAMA pediatrics 20220701 7

<h4>Importance</h4>Appropriately established pediatric reference intervals are critical to the clinical decision-making process and should reflect the physiologic changes that occur during healthy child development. Reference intervals used in pediatric care today remain highly inconsistent across a broad range of common clinical biomarkers.<h4>Observations</h4>This narrative review assesses biomarker-specific pediatric reference intervals and their clinical utility with respect to the underlyin ...[more]

PMID: 35467725

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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.

Project description:The American crocodile (Crocodylus acutus) is considered a vulnerable species by the International Union for Conservation of Nature (IUCN) Red List across its range and classified as locally threatened in several countries. There is a lack of knowledge involving hematological and physiological parameters in American crocodile populations, limiting our understanding of what are considered “normal” blood analyte results for the species and how to link them with health assessments. In this study, we analyzed 40 hematological and biochemical parameters and estimated reference intervals (RIs) for 35 of them based on 436 clinically healthy wild American crocodiles caught in South Florida between 2015 and 2021. Crocodiles were captured across three areas with different levels of human influence [low = Everglades National Park (ENP), medium = Biscayne Bay Estuary (BBE), and high = Turkey Point Nuclear Power Plant (TP)]. There was very strong-to-strong evidence for an effect of where animals were caught on five analytes: basophils %, phosphorus, proportion of (pr) alpha-2 globulins, absolute count (abs) of gamma globulins, and corticosterone, so no reference values were estimated but general statistics are presented and discussed. From the remaining analytes, we found no evidence that sex or size class had an effect on red blood cell (RBC), azurophils and monocytes abs, triglycerides, and albumin abs. However, we did find moderate-to-strong evidence that sex influenced azurophils % and size class influenced white blood cell (WBC), heterophils %, monocytes %, basophils abs, creatine phosphokinase (CPK), potassium, glucose, bile acids, alpha-1 globulin abs, and alpha-2 globulin pr and abs. Finally, there was strong evidence that both sex and size class influenced PCV, lymphocytes % and abs, eosinophils % and abs, aspartate aminotransferase (AST), calcium, sodium, chloride, total protein, albumin/globulin (A/G) ratio, albumin pr, alpha-1 globulin, and beta globulin abs. Intraspecific analysis showed that size is the variable that most influenced analytes explaining up to 29% of the variation, which relates to our findings based on intraindividual analysis. We compared our results with blood parameters reported for conspecifics as well as closely related species and discussed implication of those results for clinical diagnosis and American crocodile conservation.

Project description:ObjectivePaediatric laboratory reference intervals used in Africa and Asia may be derived from historical intervals of predominantly Caucasian infants in Europe or North America. These intervals may therefore not be compatible with the range of normality for developing country populations. We aimed to compare haematology and biochemistry parameters in healthy South African infants with local laboratory reference intervals.MethodsWe compared the baseline haematology and biochemistry results of 634 (316 male and 318 female) HIV-unexposed infants, aged 3-6 months, living in a rural area of the Western Cape Province, South Africa, against laboratory reference intervals supplied by the South African National Health Laboratory Services (NHLS). We calculated the percentage of observed values out of bound (in terms of lower and upper limits) compared to laboratory reference intervals.ResultsOf the 634 healthy infants screened, 316 (49.84%) were male and 318 (50.16%) female. A majority (91.05%) had platelet counts above the laboratory reference interval upper limit (350 × 109 cells/l), while over half, 54.85% and 56.98% had mean corpuscular volume (MCV) and mean corpuscular haemoglobin (MCH) values below the lower limits of 77.0-105.0 fl and 26.0-34.0 pg, respectively. A small proportion were outside the reference limits for haematocrit, namely 15.71% below and 7.14% above the normal limits of 0.31-0.38 l/l. For male and female infants, 33.65% and 18.04% of alkaline phosphatase (ALP) values and 7.01% and 14.56% of alanine transaminase (ALT) values were above the upper limits, respectively. For male infants, 10.83% of gamma-glutamyl transferase (GGT) values, and for female infants, 31.11% of GGT values were below the lower limits of 12 U/l for males and 15 U/l for females. We observed no significant deviations (>10% out of bound) from NHLS reference intervals in the remaining haematology and biochemistry parameters measured.ConclusionsHaematology and biochemistry parameters in apparently healthy South African infants deviate frequently from national laboratory reference intervals, including abnormalities consistent with subclinical hypochromic microcytic anaemia. It is important that clinical laboratory reference intervals for children are derived locally, rather than being adopted from Caucasian norms in developed countries, because clinical trials of vaccines, drugs and diagnostics are increasingly conducted in sub-Saharan Africa.

Project description:Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities.An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya. Laboratory values generated from the KICoS were compared to published region-specific reference intervals and the 2004 NIH DAIDS toxicity tables used for the trial.About 1106 participants were screened for the KICoS between January 2007 and June 2010. Nine hundred and fifty-three participants aged 16 to 34 years, HIV-seronegative, clinically healthy, and non-pregnant were selected for this analysis. Median and 95% reference intervals were calculated for hematological and biochemistry parameters. When compared with both published region-specific reference values and the 2004 NIH DAIDS toxicity table, it was shown that the use of locally established reference intervals would have resulted in fewer participants classified as having abnormal hematological or biochemistry values compared to US derived reference intervals from DAIDS (10% classified as abnormal by local parameters vs. >40% by US DAIDS). Blood urea nitrogen was most often out of range if US based intervals were used: <10% abnormal by local intervals compared to >83% by US based reference intervals.Differences in reference intervals for hematological and biochemical parameters between western and African populations highlight importance of developing local reference intervals for clinical care and trials in Africa.

Dataset Information

Current State of Pediatric Reference Intervals and the Importance of Correctly Describing the Biochemistry of Child Development: A Review.

Importance

Observations

Conclusions and relevance

Publications

Current State of Pediatric Reference Intervals and the Importance of Correctly Describing the Biochemistry of Child Development: A Review.

Similar Datasets

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