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Record W4414740488 · doi:10.1093/clinchem/hvaf086.543

B-149 Establishing Pediatric Reference Intervals in a US Population using Refine R

2025· article· en· W4414740488 on OpenAlexaboutno aff
Jill Kodger, Joe M El-Khoury

Bibliographic record

VenueClinical Chemistry · 2025
Typearticle
Languageen
FieldDecision Sciences
TopicReliability and Agreement in Measurement
Canadian institutionsnot available
Fundersnot available
KeywordsGuidelineCalipersReference valuesOutlierPopulationConfidence intervalRetrospective cohort study

Abstract

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Abstract Background Establishing reference intervals (RIs) is essential for accurately interpreting laboratory test results, as they help define the range of values expected in a healthy population. There are two primary methods for establishing RIs: the direct method, which involves prospectively recruiting healthy individuals, and the indirect method, which uses retrospective data from a presumed healthy population. Established studies such as CALIPER, a direct RI-derivation study conducted in Canada, aimed to address gaps in pediatric reference intervals using thousands of prospectively recruited healthy pediatric patients. However, such studies are very costly to perform and their RIs may not translate to US hospitals serving different or more diverse populations. In this study, our objective was to establish RIs using an indirect approach using RefineR and to compare our results to those of CALIPER RIs. RefineR uses advanced algorithms to adjust for biases and variables such as age, sex, and other factors, ensuring that RIs are more context-specific and accurate for clinical decision-making. A secondary objective was to also compare our findings to RIs derived per CLSI guidelines (non-parametric central 95%, with Tukey outlier elimination). Methods To evaluate, we retrieved data from 5,064 unique patients under 19 years of age who visited our outpatient clinic between 1/1/23 and 12/31/24. These data were based on results obtained on the Roche Cobas instruments for a comprehensive metabolite panel (CMP). We compared the CALIPER-derived RIs with those generated using RefineR and the non-parametric RI (NPRI) derived per CLSI guideline EP28-A3c. Results There was good agreement between CALIPER, Refine R and NPRI when the distribution of results were Gaussian, as was the case for sodium, calcium, albumin, BUN, total bilirubin, and CO2. However, discrepancies were observed for other tests. For example, our ALP levels were higher than those of CALIPER RIs for children aged 1-<10 years (CALIPER: 142-335 U/L, NPRI: 123-397 U/L, RefineR: 137-381 U/L). This discrepancy may be explained by factors such as ethnicity, geographic location, and socioeconomic status, which can all influence ALP levels, making comparisons challenging. For total protein, our population*s levels were approximately 0.5 g/dL higher on the upper end (NPRI: 5.8-7.8 g/dL, Refine R: 6.1-7.8 g/dL) compared to CALIPER RIs (5.9-7.3 g/dL). This difference is likely due to the use of both serum and plasma samples in our analysis, while CALIPER only used serum, which is known to have lower total protein. We also observed higher ALT levels in our population for the 13-19 age group (CLSI: 9-45 U/L, RefineR: 9-41 U/L) compared to CALIPER RIs (12-27 U/L). This difference may be due to unaccounted differences in important variables, like body mass index or alcohol consumption, affecting each population. Conclusion When implementing pediatric RIs, it is crucial to ensure alignment with the correct methodology and preanalytical factors (such as sample type). Discrepancies may arise if variations in patient populations or preanalytical factors are not carefully considered. It is appropriate to adopt CALIPER RIs for US pediatric population for most tests in a CMP, but not all.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.010
metaresearch head score (Gemma)0.027
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.033
Threshold uncertainty score0.981

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0100.027
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.385
GPT teacher head0.519
Teacher spread0.134 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations0
Published2025
Admission routes1
Has abstractyes

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