Evidence map›Paper›PMID 29065441›Full record

ArticleThe Korean journal of internal medicine2018

Harmonization of laboratory results by data adjustment in multicenter clinical trials.

Sang Gon Lee, Hee-Jung Chung, Jeong Bae Park, Hyosoon Park, Eun Hee Lee

Open access · goldAbstract readComparative StudyMulticenter Study
In one paragraph

Article in The Korean journal of internal medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact, top 82% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Enhancing Healthcare Data Integration: A Machine Learning Approach to Harmonizing Laboratory Labels.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Sang Gon LeeDepartment of Laboratory Medicine, Green Cross Laboratories, Yongin, Korea.
Hee-Jung ChungDepartment of Laboratory Medicine, National Cancer Center, Goyang, Korea.
Jeong Bae ParkDivision of Cardiology, Department of Medicine, Cheil General Hospital & Women's Healthcare Center, Dankook University College of Medicine, Seoul, Korea.
Hyosoon ParkDepartment of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Eun Hee LeeDepartment of Laboratory Medicine, Green Cross Laboratories, Yongin, Korea.
Green Cross (South Korea) · KRDankook University · KRKangbuk Samsung Hospital · KRNational Cancer Center · KR

Funding

Korean National Strategic Coordinating Center
6 · The paper itself

Abstract

BACKGROUND/

aimsIn multicenter clinical trials, laboratory tests are performed in the laboratory of each center, mostly using different measuring methodologies. The purpose of this study was to evaluate coefficients of variation (CVs) of laboratory results produced by various measuring methods and to determine whether mathematical data adjustment could achieve harmonization between the methods.

methodsWe chose 10 clinical laboratories, including Green Cross Laboratories (GC Labs), the central laboratory, for the measurement of total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), serum triglycerides, creatinine, and glucose. The serum panels made with patient samples referred to GC Labs were sent to the other laboratories. Twenty serum samples for each analyte were prepared, sent frozen, and analyzed by each participating laboratory.

resultsAll methods used by participating laboratories for the six analytes had traceability by reference materials and methods. When the results from the nine laboratories were compared with those from GC Labs, the mean CVs for total cholesterol, HDL-C, LDL-C, and glucose analyzed using the same method were 1.7%, 3.7%, 4.3%, and 1.7%, respectively; and those for triglycerides and creatinine analyzed using two different methods were 4.5% and 4.48%, respectively. After adjusting data using Deming regression, the mean CV were 0.7%, 1.4%, 1.8%, 1.4%, 1.6%, and 0.8% for total cholesterol, HDL-C, LDL-C, triglyceride, creatinine, and glucose, respectively.

conclusionWe found that more comparable results can be produced by laboratory data harmonization using commutable samples. Therefore, harmonization efforts should be undertaken in multicenter trials for accurate data analysis (CRIS number; KCT0001235).

Indexed as

BiomarkersBlood Chemical AnalysisBlood GlucoseBlood Specimen CollectionClinical Trials as TopicCreatinineFreezingHumansLaboratory Proficiency TestingLipidsObserver VariationPredictive Value of TestsReproducibility of ResultsRepublic of KoreaResearch DesignBiomarkersBlood GlucoseCreatinineLipidsComparable dataHarmonizationMulticenter clinical trialTraceability

Identifiers

PMID29065441
PMCPMC6234397
OpenAlexW2765555410

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.