Journal of Korean medical science
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J. Korean Med. Sci. · Mar 2024
ReviewDark Data in Real-World Evidence: Challenges, Implications, and the Imperative of Data Literacy in Medical Research.
Randomized controlled trials (RCTs) and real-world evidence (RWE) studies are crucial and complementary in generating clinical evidence. RCTs provide controlled settings to validate the clinical effect of specific drugs or medical devices, while RWE integrates extrinsic factors, encompassing external influences affecting real-world scenarios, thus challenging RCT results in practical applications. In this study, we explore the impact of extrinsic factors on RWE outcomes, focusing on "dark data," which refers to data collected but not used or excluded from the analyses. ⋯ Connecting RCTs and RWEs requires medical data literacy, enabling clinicians to decipher meaningful insights. In the big data and artificial intelligence era, medical staff must navigate data complexities while promoting the core role of medicine. Prepared clinicians will lead this transformative journey, ensuring data value shapes the medical landscape.
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J. Korean Med. Sci. · Mar 2024
Meta AnalysisChromosomal Microarray Analysis in Fetuses With Ultrasonographic Soft Markers: A Meta-Analysis of the Current Evidence.
Ultrasonographic soft markers are normal variants, rather than fetal abnormalities, and guidelines recommend a detailed survey of fetal anatomy to determine the necessity of antenatal karyotyping. Anecdotal reports have described cases with ultrasonographic soft markers in which chromosomal microarray analysis (CMA) revealed pathogenic copy number variants (CNVs) despite normal results on conventional karyotyping, but CMA for ultrasonographic soft markers remains a matter of debate. In this systematic review, we evaluated the clinical significance of CMA for pregnancies with isolated ultrasonographic soft markers and a normal fetal karyotype. ⋯ CMA could aid in risk assessment and pregnancy counseling in pregnancies where the fetus has isolated ultrasonographic soft markers along with a normal karyotype.