Suggestions for designing studies investigating diagnostic accuracy of biomarkers

Zhang, Man; Hu, Zhide

doi:10.21037/atm.2019.11.133

Cited by 20 publications

(17 citation statements)

References 25 publications

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“…The index test domain of all included studies has a high risk of bias because these studies used a data-driven method to define the diagnostic threshold of circulating miR-126. The flow and timing domain in three studies was labeled “high” because not all subjects received the same reference, termed as partial verification bias ( 24 ).…”

Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of circulating miR-126 for malignant pleural mesothelioma: a systematic review and meta-analysis

Zhang¹,

Zhou²,

Han³

et al. 2021

Transl Cancer Res TCR

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Background: Circulating microRNAs are novel diagnostic markers for various types of cancer. Several studies have investigated the diagnostic accuracy of circulating miR-126 for malignant pleural mesothelioma (MPM), but the results varied. Therefore, we performed a systematic review and meta-analysis to investigate the diagnostic value of circulating miR-126 for MPM. Methods:The PubMed database was searched to identify potentially eligible studies published before October 2020. The studies investigating the diagnostic value of circulating miR-126 for MPM were included in a systematic review and meta-analysis. A bivariate model was used to pool eligible studies' sensitivity and specificity. The revised tool for the quality assessment of diagnostic accuracy studies (QUADAS-2) was used to assess eligible studies' quality.Results: Four studies with 156 MPM patients and 459 controls were included in this systematic review and meta-analysis. The pooled diagnostic sensitivity and specificity of circulating miR-126 for MPM were 0.71 and 0.69, respectively. A high risk of bias was observed in the domains of patient selection, index test, and flow and timing.Conclusions: Circulating miR-126 has limited value for diagnosing MPM. Considering that the available studies have a high risk of bias, further rigorous studies are needed to assess the diagnostic value of circulating miR-126 for MPM.

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Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of circulating miR-126 for malignant pleural mesothelioma: a systematic review and meta-analysis

Zhang¹,

Zhou²,

Han³

et al. 2021

Transl Cancer Res TCR

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“…For example, only lung cancer patients were enrolled in the MPE group, and thus the disease spectrum may not be representative enough of the common malignancies causing PE in clinical practice. Moreover, subjects' enrollment in some studies was not consecutive, and this may have led to a selection bias (138).…”

Section: Discussionmentioning

confidence: 99%

Pleural biomarkers in diagnostics of malignant pleural effusion: a narrative review

Zhang¹,

Li²,

Lippi³

et al. 2021

Transl Lung Cancer Res

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Although cytology and pleural biopsy of pleural effusion (PE) are the gold standards for diagnosing malignant pleural effusion (MPE), these tools' diagnostic accuracy is plagued by some limitations such as low sensitivity, considerable inter-observer variation and invasiveness. The assessment of PE biomarkers may hence be seen as an objective and non-invasive diagnostic alternative in MPE diagnostics. In this review, we summarize the characteristics and diagnostic accuracy of available PE biomarkers, including carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), carbohydrate antigens 125 (CA125), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 15-3 (CA15-3), a fragment of cytokeratin 19 (CYFRA 21-1), chitinase-like proteins (CLPs), vascular endothelial growth factor (VEGF) and its soluble receptor, endostatin, calprotectin, cancer ratio, homocysteine, apolipoprotein E (Apo-E), B7 family members, matrix metalloproteinase (MMPs) and tissue-specific inhibitors of metalloproteinases (TIMPs), reactive oxygen species modulator 1 (Romo1), tumor-associated macrophages (TAMs) and monocytes, epigenetic markers (e.g., cell-free microRNA and mRNA). We summarized the evidence from systematic review and meta-analysis for traditional tumor markers' diagnostic accuracy. According to the currently available evidence, we conclude that the traditional tumor markers have high specificity (around 0.90) but low sensitivity (around 0.50). The diagnostic accuracy of novel tumor markers needs to be validated by further studies. None of these tumor biomarkers would have sufficient diagnostic accuracy to confirm or exclude MPE when used alone. A multi-biomarker strategy, also encompassing the use of artificial intelligence algorithms, may be a valuable perspective for improving the diagnostic accuracy of MPE.

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“…PPV and NPV are two meaningful metrics in diagnostic test accuracy study because they directly reflect the probability of target disease for a patient with positive or negative results. Both PPV and NPV are greatly affected by the disease prevalence in target population 36 . Previous epidemiological studies reveal that KD's prevalence varied across countries or regions 1‐5 .…”

Section: Discussionmentioning

confidence: 99%

Diagnostic accuracy of N‐terminal pro‐brain natriuretic peptide for Kawasaki disease: An updated systematic review and meta‐analysis

et al. 2021

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Objective This study aimed to investigate the diagnostic accuracy of circulating N‐terminal pro‐brain natriuretic peptide (NT‐proBNP) for Kawasaki disease (KD). Methods We searched the PubMed, Web of Science and EMBASE databases to identify the eligible studies investigating the diagnostic accuracy of NT‐proBNP for KD. The revised tool for the quality assessment of diagnostic accuracy studies (QUADAS‐2) was used to evaluate the eligible studies' quality. A meta‐analysis was performed with the bivariate model and summary receiver operating characteristic (sROC) curve. We also performed subgroup, publication bias and sensitivity analyses. Results We included 12 studies with 2173 KDs and 1909 control. The pooled sensitivity and specificity of eligible studies were 0.80 (95%CI: 0.72‐0.86) and 0.81 (95%CI: 0.73‐0.88), respectively. The area under sROC curve was 0.88 (95%CI: 0.84‐0.90). Patient selection bias and partial verification bias were the major design weakness of the eligible studies. Sensitivity analysis revealed that the results of this meta‐analysis were robust. Subgroup analysis revealed that study design, NT‐proBNP assay and participants' body temperature were not the source of heterogeneity across all eligible studies. No publication bias was observed. Conclusion NT‐proBNP has moderate diagnostic accuracy for KD. It cannot be used for ruling in or ruling out KD when used alone.

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Suggestions for designing studies investigating diagnostic accuracy of biomarkers

Cited by 20 publications

References 25 publications

Diagnostic accuracy of circulating miR-126 for malignant pleural mesothelioma: a systematic review and meta-analysis

Diagnostic accuracy of circulating miR-126 for malignant pleural mesothelioma: a systematic review and meta-analysis

Pleural biomarkers in diagnostics of malignant pleural effusion: a narrative review

Diagnostic accuracy of N‐terminal pro‐brain natriuretic peptide for Kawasaki disease: An updated systematic review and meta‐analysis

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