ArticleClinical chemistry2019
Inadequate Reporting of Analytical Characteristics of Biomarkers Used in Clinical Research: A Threat to Interpretation and Replication of Study Findings.
Article in Clinical chemistry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Drug-drug interactions between vitamin K antagonists and statins: a systematic review.European journal of clinical pharmacology · 2021Pooled it
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- DAMPs and PAMPs in the Perioperative Period: Danger Signaling, Immune Dysfunction, and Oncologic Implications.Medicina (Kaunas, Lithuania) · 2026Review
- Rethinking the Limit of Detection for Serum Ethanol: Evidence from a Clinical Laboratory.EJIFCC · 2026Article
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- The promising cancer treatment approach in cancer immunotherapy: dendritic cell-based vaccines.Frontiers in immunology · 2026Review
- Rigorous validation of machine learning in laboratory medicine: guidance toward quality improvement.Critical reviews in clinical laboratory sciences · 2025Review
- Ionized and total magnesium levels and health outcomes in patients with type 2 diabetes mellitus.Scientific reports · 2025Article
- Prevalence, clinical characteristics, and health outcomes of dysmagnesemia measured by ionized and total body concentrations among medically hospitalized patients.Scientific reports · 2024Article
- Developing a reporting item checklist for studies of HIV drug resistance prevalence or incidence: a mixed methods study.BMJ open · 2024Article
- The Stability of Analytes of Ionized Magnesium Concentration and Its Reference Range in Healthy Volunteers.Biomedicines · 2023Article
- The publication quality of laboratory values in clinical studies in neonates.Pediatric research · 2023Article
- Machine learning within the Parkinson's progression markers initiative: Review of the current state of affairs.Frontiers in aging neuroscience · 2023Review
- Call for Action: Journals Need to Insist on Full Reporting of the Analytical Characteristics of Biomarkers.Laboratory medicine · 2021Article
- Testing COVID-19 tests faces methodological challenges.Journal of clinical epidemiology · 2020Review
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAnalytical characteristics of methods to measure biomarkers determine how well the methods measure what they claim to measure. Transparent reporting of analytical characteristics allows readers to assess the validity and generalizability of clinical studies in which biomarkers are used. Our aims were to assess the reporting of analytical characteristics of biomarkers used in clinical research and to evaluate the extent of reported characterization procedures for assay precision.
methodsWe searched 5 medical journals (
resultsA total of 544 studies and 1299 biomarker uses met the inclusion criteria. No information on analytical characteristics was reported for 67% of the biomarkers. For 65 biomarkers (3%), ≥4 characteristics were reported (range, 4-8). The manufacturer of the measurement procedure could not be determined for 688 (53%) of the 1299 biomarkers. The extent of assessments of assay imprecision, when reported, did not meet expectations for clinical use of biomarkers.
conclusionsReporting of the analytical performance of biomarker measurements is variable and often absent from published clinical studies. We suggest that readers need fuller reporting of analytical characteristics to interpret study results, assess generalizability of conclusions, and compare results among clinical studies.
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