Summary Receiver Operating Characteristic Research Articles

Long non-coding RNA as potential diagnostic markers for acute myeloid leukemia: A systematic review and meta-analysis.

Acute myeloid leukemia (AML) is aggressive type of hematological malignancy. Its poses challenges in early diagnosis, necessitating the identification of an effective biomarker. This study aims to assess the diagnostic accuracy of long noncoding RNAs (lncRNA) in the diagnosis of AML through a meta-analysis. The study is registered on the PROSPERO website with the number 493518. A literature search was conducted in the PubMed, Embase, Hinari, and the Scopus databases to identify relevant studies. We pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and area under the summary receiver operating characteristics (ROC) using Stata 14.1 software. Heterogeneity between studies was determined through the I2 statistic and Cochran-Q test. A random effect model was chosen due to significant heterogeneity among included studies. Meta-regression and subgroup analysis were performed to assess the potential source of heterogeneity. Furthermore, potential publication bias was estimated using Deek's funnel plot asymmetry test. A total of 14 articles covering 19 studies were included in this meta-analysis comprising 1588 AML patients and 529 healthy participants. The overall pooled sensitivity, specificity, PLR, NLR, DOR, and the area under the summary ROC curve were 0.85 (95% CI = 0.78-0.91), 0.82 (95% CI = 0.72-0.89), 4.7 (95% CI = 2.9-7.4), 0.18 (95% CI = 0.12-0.28), 26 (95% CI = 12-53), and 0.90 (95% CI = 0.87-0.93), respectively. Moreover, lncRNAs from non-bone marrow mononuclear cells (BMMC) had superior diagnostic value with pooled sensitivity, specificity, and AUC were 0.93, 0.82, and 0.95, respectively. This meta-analysis demonstrated that circulating lncRNAs can serve as potential diagnostic markers for AML. High accuracy of diagnosis was observed in non-BMMC lncRNAs, given cutoff value, and the GADPH internal reference gene used. However, further studies with large sample size are required to confirm our results.

Prediction accuracy of biomarkers for response to immune checkpoint inhibitors in advanced non-small cell lung cancer: A systematic review and meta-analysis.

e14652 Background: To compare the predictive accuracy of PD-L1 IHC, tissue or blood tumor mutation burden (tTMB, bTMB), gene expression profiling (GEP), driver gene mutation, and combined marker for immunotherapy response of advanced non-small cell lung cancer (NSCLC). Methods: Systematic searches of PubMed, Cochrane CENTRAL, and Embase were conducted from inception to July 6, 2023. Clinical trials involved with predictive biomarkers exploration for immune checkpoint inhibitors (ICIs) in advanced NSCLC were eligible. The response according to the biomarkers were extracted. The primary outcome was the area under the curve (AUC) of the summary receiver operating characteristic (SROC). Sensitivity, specificity, likelihood ratios and predictive values were evaluated. The subgroup analysis of different PD-L1 cut-off, TMB test and driver gene mutation were performed. Results: 36 articles of 59 biomarker tests were included. The AUC of combined marker (0.75; 95%CI, 0.71-0.78) was higher than PD-L1 (0.64; 95%CI, 0.60-0.68), tTMB (0.64; 95%CI, 0.60-0.68), bTMB (0.68; 95%CI, 0.64-0.72), GEP (0.67; 95%CI, 0.63-0.71), and driver gene mutation (0.51; 95%CI, 0.47-0.55). Combined marker also had higher specificity, positive likelihood ratio and positive predictive value than single biomarkers (Table). In subgroup analysis, PD-L1 with cut-off 50% had higher AUC (0.67; 95%CI, 0.63-0.71) than cut-off 1% (0.62; 95%CI, 0.58-0.66); EGFR mutation had higher AUC (0.69; 95%CI, 0.65-0.73) than KRAS (0.53; 95%CI, 0.49-0.58); tTMB measured by Whole Exosome Sequencing (WES) had approximate AUC to that measure by targeted gene panel. The predictive accuracy of the biomarkers was further compared for patients receiving ICI-based combination therapy. The AUC of combined marker (0.70; 95%CI, 0.66-0.74) remained the highest for combination therapy. Conclusions: Combined marker (PD-L1+tTMB/bTMB/GEP) has superior predictive accuracy than single biomarkers for immunotherapy response of NSCLC. bTMB is a promising liquid biopsy biomarker. The prescription of ICI for patients with EGFR mutation should be cautious. Further investigation is warranted to precisely identify biomarkers in various clinical settings. [Table: see text]

The diagnostic performance of mean neutrophil volume in neonatal sepsis: A systematic review and meta-analysis

BackgroundThere is a need for reliable diagnostic tests for early identification of sepsis to prevent neonatal mortality and antibiotic misuse. During sepsis, many immature neutrophils came into the bloodstream, altering the mean neutrophil volume (MNV) shown in the previous studies. ObjectivesTo summarize the diagnostic performance of mean neutrophil volume (MNV) in neonatal sepsis from the published literature. MethodDatabases such as PubMed, Scopus, and Web of Science were searched from January 1990 to April 2023 for studies reporting MNV as a diagnostic test in neonatal sepsis. The pooled sensitivity, specificity, diagnostic odds ratio (DOR), and area under the curve (AUC) of the summary receiver operating characteristic (SROC) curve of MNV were estimated with reference blood culture-positive sepsis and clinical sepsis for meta-analysis. ResultThe diagnostic performance of MNV was analyzed in 1685 neonates, including 829 septic and 856 non-septic neonates, from six prospective studies. The pooled sensitivity and specificity of MNV were 0.87 and 0.75, respectively, for neonatal sepsis; the DOR was 20.01 (95% CI: 5.90–67.82); and the AUC of the SROC for MNV was 0.81 (95% CI: 0.69–0.88). Higgins I2 was 92.1% (95% CI: 85.5%–95.7%). The diagnostic performance of MNV was better during sub-group analysis of studies reporting culture-positive sepsis (DOR 85.61). ConclusionThe diagnostic performance of MNV is moderate for neonatal sepsis. As the evidence originated from a small number of studies with marked heterogeneity, further large-scale diagnostic accuracy studies are recommended to resolve heterogeneity in the future.

Accuracy of Salivary Circulating Tumor Human Papillomavirus DNA in Detecting Oropharyngeal Cancer

Circulating tumor human papillomavirus DNA (ctHPV DNA) has shown potential as a biomarker capable of improving outcomes in patients with HPV-related oropharyngeal (OP) cancer. It can be isolated from plasma or saliva, with the latter offering reduced invasiveness and theoretic reduction of lead time. To perform a systematic review and meta-analysis on the accuracy of salivary ctHPV DNA for detecting HPV-associated OP cancer. Cochrane Library, Embase, PubMed, and Web of Science databases were searched from inception through October 2023. All patients who underwent salivary ctHPV DNA testing at presentation for possible or diagnosed HPV-related OP cancer were included. Non-English and review publications were excluded. Two authors independently voted on article inclusion with a third resolving conflicting votes. Following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines, multiple authors independently abstracted data and assessed bias of included articles. Bivariate random-effects meta-analysis was performed with I2 to assess for study heterogeneity. Sensitivities, specificities, positive likelihood ratios (PLR), negative likelihood ratios (NLR), and diagnostic odds ratios (DOR) with 95% CIs alongside area under the curve (AUC) of a summary receiver operating characteristic (SROC) curve were calculated. The initial analysis took place throughout December 2023. Of 440 initially identified articles, 6 met inclusion criteria and demonstrated moderate heterogeneity (I2 = 36%) with low risk of bias and low applicability concerns. Overall, 263 total patients were included with a median (range) age of 58 (39-86) years, and 228 (87%) were male patients. Per updated prognostic staging criteria, localized tumors (ie, stages 1 or 2) comprised most cancers at 139 (77%), whereas advanced ones (ie, stages 3 or 4) comprised the remaining 41 (23%). Pooled sensitivity, specificity, PLR, NLR, and DOR values were 64% (95% CI, 36%-85%), 89% (95% CI, 46%-99%), 11.70 (95% CI, 0.37-77.00), 1.21 (95% CI, 0.08-7.00), and 139.00 (95% CI, 0.05-837.00), respectively. The AUC of the SROC curve was 0.80. This study supports salivary ctHPV DNA as an acceptably specific test in detecting HPV-associated OP cancer that would benefit from testing in clinical trials prior to real-time implementation.

Evaluating the diagnostic accuracy of heat shock proteins and their combination with Alpha-Fetoprotein in the detection of hepatocellular carcinoma: a meta-analysis

BackgroundA growing body of research suggests that heat shock proteins (HSPs) may serve as diagnostic biomarkers for hepatocellular carcinoma (HCC), but their results are still controversial. This meta-analysis endeavors to evaluate the diagnostic accuracy of HSPs both independently and in conjunction with alpha-fetoprotein (AFP) as novel biomarkers for HCC detection.MethodsPooled statistical indices, including sensitivity, specificity, diagnostic odds ratio (DOR), positive likelihood ratio (PLR), and negative likelihood ratio (NLR) with 95% confidence intervals (CI), were computed to assess the diagnostic accuracy of HSPs, AFP, and their combinations. Additionally, the area under the summary receiver operating characteristic (SROC) curve (AUC) was determined.ResultsA total of 2013 HCC patients and 1031 control subjects from nine studies were included in this meta-analysis. The summary estimates for HSPs and AFP are as follows: sensitivity of 0.78 (95% CI: 0.69–0.85) compared to 0.73 (95% CI: 0.65–0.80); specificity of 0.89 (95% CI: 0.81–0.95) compared to 0.86 (95% CI: 0.77–0.91); PLR of 7.4 (95% CI: 3.7–14.9) compared to 5.1 (95% CI: 3.3–8.1); NLR of 0.24 (95% CI: 0.16–0.37) compared to 0.31 (95% CI: 0.24–0.41); DOR of 30.19 (95% CI: 10.68–85.37) compared to 16.34 (95% CI: 9.69–27.56); and AUC of 0.90 (95% CI: 0.87–0.92) compared to 0.85 (95% CI: 0.82–0.88). The pooled sensitivity, specificity, PLR, NLR, DOR and AUC were 0.90 (95% CI: 0.82–0.95), 0.94 (95% CI: 0.82–0.98), 14.5 (95% CI: 4.6–45.4), 0.11 (95% CI: 0.06–0.20), 133.34 (95% CI: 29.65–599.61), and 0.96 (95% CI: 0.94–0.98) for the combination of HSPs and AFP.ConclusionOur analysis suggests that HSPs have potential as a biomarker for clinical use in the diagnosis of HCC, and the concurrent utilization of HSPs and AFP shows notable diagnostic effectiveness for HCC.

MRI and SPECT/CT demonstrate, with low certainty of evidence, the highest diagnostic accuracy for aseptic knee arthroplasty loosening: A systematic comparative diagnostic test review and meta-analysis.

The purpose of this study was to evaluate and compare the diagnostic accuracy of modalities used to aid the diagnosis of aseptic knee arthroplasty loosening. A comparative diagnostic test accuracy systematic review and meta-analysis was conducted following the Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. PubMed, EMBASEand Cochrane databases were searched for original articles evaluating diagnostic modalities up to March 2024. Included studies compared the modality (index test) to the intraoperative finding as reference test. The QUADAS-C (Quality Assessment of Diagnostic Accuracy Studies-Comparative)tool was used to assess the quality of the included studies. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach was used to evaluate the certainty of evidence. Level of evidence was evaluated using the Oxford Levels of Evidence tool. The primary outcome wasthe summary of diagnostic accuracy metrics for each modality as demonstrated by a summary receiver-operating characteristic (SROC) curve. The search yielded 467 articles. Of these, 14 articles were included. These 14 articles evaluated a total of five different diagnostic modalities: bone scintigraphy (three studies, 146 cases), 18-fluorodeoxyglucose positron emission tomography(two studies, 50 cases), single-photon emission computed tomography combined with computed tomography (SPECT/CT) (seven studies, 371 cases), radionuclide arthrogram (three studies, 196 cases)and magnetic resonance imaging (MRI) (one study, 116 cases). Nine studies exhibited a high risk of bias in patient selection, and all studies showed a high risk of bias related to the reference test. The majority of the included studies were classified as Level III evidence, leading to an overall low level of certainty in the evidence. The most accurate tests, as demonstrated by the SROC analysis, were MRI and SPECT/CT, with sensitivities ranging from 0.00 to 1.00 and 0.33 to 1.00 and specificities between 0.31-1.00 and 0.00-1.00, respectively. This review and meta-analysis evaluated available diagnostic modalities to aid the diagnosis of knee arthroplasty loosening and based on a low certainty of evidence suggests that MRI and SPECT/CT are currently the most accurate modalities available to aid the diagnosis of aseptic loosening of knee arthroplasty components. Level III.

Prognostic Value of Sublingual Microcirculation in Sepsis: A Systematic Review and Meta-analysis.

Objectives: To investigate the relationship between sublingual microcirculation and the prognosis of sepsis. Data sources: The PubMed, Web of Science, Embase, and China National Knowledge Infrastructure (CNKI) databases were searched to identify studies published from January 2003 to November 2023. Study selection: Clinical studies examining sublingual microcirculation and the prognosis of sepsis were included. Data extraction: Sublingual microcirculation indices included the microvascular blood index (MFI), total vascular density (TVD), perfusion vascular density (PVD), perfusion vascular vessel (PPV), and heterogeneity index (HI). Prognostic outcomes included mortality and severity. Funnel plots and Egger's test were used to detect publication bias. The ability of the small vessel PPV (PPVs) to predict sepsis-related mortality was analyzed based on the summary receiver operating characteristic (SROC) curve, pooled sensitivity, and pooled specificity. Data synthesis: Twenty-five studies involving 1750 subjects were included. The TVD (95% CI 0.11-0.39), PVD (95% CI 0.42-0.88), PPV (95% CI 6.63-13.83), and MFI (95% CI 0.13-0.6) of the survival group were greater than those of the nonsurvival group. The HI in the survival group was lower than that in the nonsurvival group (95% CI -0.49 to -0.03). The TVD (95% CI 0.41-0.83), PVD (95% CI 0.83-1.17), PPV (95% CI 14.49-24.9), and MFI (95% CI 0.25-0.66) of the nonsevere group were greater than those of the severe group. Subgroup analysis revealed no significant difference in TVD between the survival group and the nonsurvival group in the small vessel subgroup. The area under the SROC curve (AUC) was 0.88. Conclusions: Sublingual microcirculation was worse among patients who died and patients with severe sepsis than among patients who survived and patients with nonsevere sepsis. PPV has a good predictive value for the mortality of sepsis patients. This study was recorded in PROSPERO (registration number: CRD42023486349).

Three-dimensional sonography has satisfied accuracy for detecting rotator cuff tears.

Rotator cuff injuries and tears are common causes of shoulder pain and dysfunction, necessitating accurate diagnostic methods to guide clinical decision-making. This study evaluates the diagnostic utility of three-dimensional (3D) shoulder sonography in identifying rotator cuff injury and tear patterns. A comprehensive search across seven electronic databases, which included Cochrane Library, Embase, PubMed, Cochrane Library, China Biology Medicine (CBM) database, CNKI, Wanfang, and VIP database. These databases were utilized to retrieve articles that assess the diagnostic value of 3D shoulder sonography for identifying rotator cuff injuries and tear patterns. The effectiveness of 3D shoulder sonography was assessed in terms of sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR). For each parameter, the 95% confidence intervals were calculated. Additionally, summary receiver operating characteristic curves (SROCs) were constructed, allowing for a comprehensive evaluation of diagnostic accuracy, which is reflected in the area under the SROC curve (AUC). Screening of 8,508 identified nine literatures eligible for inclusion in the meta-analysis, encompassing a total of 366 patients. The analysis of detecting any rotator cuff tear revealed a sensitivity of 0.97 and specificity of 0.87, yielding a DOR of 90.03 and an AUC of 0.98. Furthermore, 3D shoulder sonography demonstrated satisfactory accuracy in detecting both full and partial-thickness rotator cuff tears (Sensitivity: 0.92 vs. 0.83, specificity: 0.94 vs. 097, and AUC: 0.96 vs. 0.95). This study indicates that three-dimensional sonography has satisfied accuracy for detecting rotator cuff tears.

A meta-analysis of MRI radiomics-based diagnosis for BI-RADS 4 breast lesions

ObjectiveThe aim of this study is to conduct a systematic evaluation of the diagnostic efficacy of Breast Imaging Reporting and Data System (BI-RADS) 4 benign and malignant breast lesions using magnetic resonance imaging (MRI) radiomics.MethodsA systematic search identified relevant studies. Eligible studies were screened, assessed for quality, and analyzed for diagnostic accuracy. Subgroup and sensitivity analyses explored heterogeneity, while publication bias, clinical relevance and threshold effect were evaluated.ResultsThis study analyzed a total of 11 studies involving 1,915 lesions in 1,893 patients with BI-RADS 4 classification. The results showed that the combined sensitivity and specificity of MRI radiomics for diagnosing BI-RADS 4 lesions were 0.88 (95% CI 0.83–0.92) and 0.79 (95% CI 0.72–0.84). The positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR) were 4.2 (95% CI 3.1–5.7), 0.15 (95% CI: 0.10–0.22), and 29.0 (95% CI 15–55). The summary receiver operating characteristic (SROC) analysis yielded an area under the curve (AUC) of 0.90 (95% CI 0.87–0.92), indicating good diagnostic performance. The study found no significant threshold effect or publication bias, and heterogeneity among studies was attributed to various factors like feature selection algorithm, radiomics algorithms, etc. Overall, the results suggest that MRI radiomics has the potential to improve the diagnostic accuracy of BI-RADS 4 lesions and enhance patient outcomes.ConclusionMRI-based radiomics is highly effective in diagnosing BI-RADS 4 benign and malignant breast lesions, enabling improving patients’ medical outcomes and quality of life.

Diagnostic efficacy of long non-coding RNAs in multiple sclerosis: a systematic review and meta-analysis.

Currently, an increasing body of research suggests that blood-based long non-coding RNAs (lncRNAs) could serve as biomarkers for diagnosing multiple sclerosis (MS). This meta-analysis evaluates the diagnostic capabilities of selected lncRNAs in distinguishing individuals with MS from healthy controls and in differentiating between the relapsing and remitting phases of the disease. We conducted comprehensive searches across seven databases in both Chinese and English to identify relevant studies, applying stringent inclusion and exclusion criteria. The quality of the selected references was rigorously assessed using the QUADAS-2 tool. The analysis involved calculating summarized sensitivity (SSEN), specificity (SSPE), positive likelihood ratio (SPLR), negative likelihood ratio (SNLR), and diagnostic odds ratio (DOR) with 95% confidence intervals (CIs). Accuracy was assessed using summary receiver operating characteristic (SROC) curves. Thirteen high-quality studies were selected for inclusion in the meta-analysis. Our meta-analysis assessed the combined diagnostic performance of lncRNAs in distinguishing MS patients from healthy controls. We found a SSEN of 0.81 (95% CI: 0.74-0.87), SSPE of 0.84 (95% CI: 0.78-0.89), SPLR of 5.14 (95% CI: 3.63-7.28), SNLR of 0.22 (95% CI: 0.16-0.31), and DOR of 23.17 (95% CI: 14.07-38.17), with an AUC of 0.90 (95% CI: 0.87-0.92). For differentiating between relapsing and remitting MS, the results showed a SSEN of 0.79 (95% CI: 0.71-0.85), SSPE of 0.76 (95% CI: 0.64-0.85), SPLR of 3.34 (95% CI: 2.09-5.33), SNLR of 0.28 (95% CI: 0.19-0.40), and DOR of 12.09 (95% CI: 5.70-25.68), with an AUC of 0.84 (95% CI: 0.81-0.87). This analysis underscores the significant role of lncRNAs as biomarkers in MS diagnosis and differentiation between its relapsing and remitting forms.

Diagnostic performance of F-18 FDG PET/CT in differentiating autoimmune pancreatitis from pancreatic cancer: a systemic review and meta-analysis.

This study aims to evaluate the utility of F-18 FDG PET/CT in the non-invasive diagnosis of autoimmune pancreatitis (AIP) and differentiating it from pancreatic cancer (CaP) based on the amount and pattern of FDG uptake, as well as involvement of extra-pancreatic sites. A systematic search was conducted using PubMed, Scopus, Cochrane Library and Google Scholar. Only those studies that compared the findings of F-18 FDG PET/CT in terms of SUVmax, pattern of FDG uptake and presence of FDG-avid extra-pancreatic sites in both AIP and CaP were included. Studies were qualitatively assessed for risk of bias and publication bias. The diagnostic performance of parameters on PET/CT was examined through pooled sensitivity, specificity, diagnostic odd's ratio (DOR) and summary receiver operator characteristic (SROC) curve analysis. Six studies were included with a total of 580 patients. 178 patients had AIP (Age 18-90years, male, M: female, F ratio-8.4:1) and 402 patients had CaP (Age 22-88years, M:F ratio-1.5:1). Type of AIP was reported in only 3 studies, with the included cases predominantly being type 1 AIP. All studies were retrospective with heterogeneity and a risk on patient selection and index test. The FDG uptake, expressed as SUVmax, was lower in AIP with a weighted mean difference of -3.11 (95% confidence interval, CI: -5.28 to -0.94). To diagnose AIP, the pooled sensitivity, specificity and DOR of diffuse pattern of FDG uptake were 0.59 (95% CI: 0.51-0.66), 0.89 (95% CI: 0.86-0.92) and 21.07 (95% CI: 5.07-88.32), respectively, with an area under curve (AUC) of 0.717 on SROC analysis. The pooled sensitivity, specificity and DOR of FDG-avid extra pancreatic sites were 0.55 (95% CI: 0.45-0.65), 0.58 (95% CI: 0.52-0.64) and 2.33 (95% CI: 1.40-3.89), respectively, with an AUC of 0.632. On F-18 FDG PET/CT, a pancreatic lesion of AIP has a lower SUVmax value than CaP. A diffuse pattern of FDG uptake and presence of an extra-pancreatic FDG-avid site are nearly 21 times and twice more likely in AIP than CaP, respectively.

Higher diagnostic value of next-generation sequencing versus culture in periprosthetic joint infection: A systematic review and meta-analysis.

The next-generation sequencing (NGS) has developed rapidly in the past decade and is becoming a promising diagnostic tool for periprosthetic infection (PJI). However, its diagnostic value for PJI is still uncertain. The purpose of this systematic review and meta-analysis was to evaluate the diagnostic value of NGS compared to culture. In this systematic review and meta-analysis, electronic databases including PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science and clinicaltrials.gov were searched for studies from inception to 12 November 2023. Diagnostic parameters, such as sensitivity, specificity, diagnostic odds ratio and area under the summary receiver-operating characteristic (SROC) curve (AUC), were calculated for the included studies. A systematic review and meta-analysis was performed. A total of 22 studies with 2461 patients were included in our study. The pooled sensitivity, specificity and diagnostic odds ratio of NGS were 87% (95% confidence interval [CI]: 83-90), 94% (95% CI: 91-96) and 111 (95% CI: 70-177), respectively. On the other hand, the pooled sensitivity, specificity and diagnostic odds ratio of culture were 63% (95% CI: 58-67), 98% (95% CI: 96-99) and 93 (95% CI: 40-212), respectively. The SROC curve for NGS and culture showed that the AUCs are 0.96 (95% CI: 0.94-0.98) and 0.82 (95% CI: 0.79-0.86), respectively. This systematic review and meta-analysis found NGS had higher sensitivity and diagnostic accuracy but slightly lower specificity than culture. Based on the pooled results, we suggested NGS may have the potential to be a new tool for the diagnosis of PJI. Level IV.

Diagnostic accuracy of pancreatic stone protein in patients with sepsis: a systematic review and meta-analysis

BackgroundSepsis is a common syndrome of multiorgan system dysfunction secondary to the dysregulated inflammatory response to infection. The role of pancreatic stone protein (PSP) in diagnosing sepsis has been investigated in previous studies. The meta-analysis aimed to comprehensively investigate the diagnostic value of PSP in identifying sepsis.MethodsPubMed, Web of Science, Embase, Cochrane Library, and China National Knowledge Infrastructure (CNKI), were systematically searched. Studies investigating the diagnostic performance of PSP were included. Pooled sensitivity, specificity, positive Likelihood Ratio (+ LR) and negative Likelihood Ratio (-LR), diagnostic odds ratio (DOR), and area under the curve (AUC) of summary receiver operating characteristic (SROC) were calculated.ResultsThe sensitivity of PSP was 0.88 (95% CI: 0.77–0.94), and the pooled specificity was 0.78 (95% CI: 0.65–0.87). Pooled + LR, -LR, and DOR were 4.1 (2.3, 7.3), 0.16 (0.07, 0.34), and 26 (7, 98). The AUC value for the SROC of PSP was 0.90 (0.87, 0.92). The pooled sensitivity, specificity, + LR and - LR, and DOR for PSP among neonates were 0.91 (95% CI: 0.84, 0.96), 0.66 (95% CI: 0.58, 0.74), 3.97 (95% CI: 0.53, 29.58), 0.13 (95% CI: 0.02, 1.00), and 31.27 (95% CI: 0.97, 1004.60).ConclusionsThis study indicates that PSP demonstrated favorable diagnostic accuracy in detecting sepsis. Well-designed studies are warranted to ascertain the value of PSP measurement to guide early empirical antibiotic treatment, particularly in neonates.

Abstract PO4-27-10: A Systematic Review and Meta-analysis of Diagnostic Performance of Fluorescein Guided Sentinel Lymph Node Biopsy in Early Breast Cancer

Abstract Background: Evaluation of axillary lymph nodes status in cN0 axilla is performed by sentinel lymph node biopsy (SLNB) utilizing a combination of radioactive isotope and blue dye. There is a paucity of radioactive tracer in many countries of transitional economies. Hence, alternatives to isotope have been explored, viz. indocyanine green (ICG), superparamagnetic iron oxide nanoparticles and Fluorescein Sodium (FS). This systematic review and meta-analysis, evaluates the diagnostic performance of Fluorescein Sodium guided SLNB. Objectives: The objective was to evaluate the diagnostic performance of Fluorescein Sodium for sentinel lymph node biopsy in early breast cancer. Methods: PRISMA 2020 guidelines were followed for this meta-analysis. Eligibility criteria: Studies where SLNB was performed using Fluorescein Sodium for breast carcinoma. Information sources: PubMed, EMBASE, Cochrane library and online clinical trial registers Risk of bias: Articles were assessed for risk of bias using the QUADAS-2 tool. Synthesis of results: The main summary measures were pooled detection rate and pooled false negative rate using random effects model. In order to describe heterogeneity, we constructed summary receiver operating characteristic (SROC) curves with 95% prediction regions, estimated using bivariate meta-analysis with a test level random effect only, and forest plots. Calculations were performed using the Meta-Disc v1.4 program (available from https://metadisc.software.informer.com/1.4/). Results: Out of 45 studies found on initial systematic search, 7 studies were found eligible and were included in the meta-analysis based on data on 332 patients. The pooled detection rate was 93.2% (95% confidence interval [CI] 87% to 97%).). The heterogeneity (I2 value) of the pooled detection rate was 71%. Five validation studies were included for pooling the false negative rate (FNR) and included a total of 211 patients. The pooled FNR was 5.6% (95% CI; 2.9 to 9.07). Five validation studies were included for sensitivity, specificity, diagnostic odds ratio, LR+ and LR- meta-analysis. With regards to the identification of SLN the pooled sensitivity was 80% [(95% CI, 68% to 89%); I2=79.8]; specificity was 98% [(95% CI, 95% to 100%); I2=0.0]. The likelihood ratio for a positive test LR+ was 23.2 [(95% CI, 5.91 to 95.18); I2=0.0] and likelihood ratio for a negative test a LR- of 0.41 [(95% CI, 0.16 to 1.05); I2=88.1]. The diagnostic Odds ratio OR was 76.94 (95% CI, 15.88 to 372.79). Diagnostic accuracy as measured by SROC was 99.08%. Q index was 0.96. Publication bias for pooled detection rate as per Egger’s test was -2.2 (p= 0.66) and for FNR was 1.85 (p=0.29). Visual inspection of summary ROC curve and of forest plots did not show significant heterogeneity. Conclusion: Fluorescein guided SLNB is an affordable option for detection of lymph node metastases in cN0 patients with early breast cancer. It achieves a high detection rate of 93% with a false negative rate of 5.6% for the detection of axillary lymph node metastasis. We recommend larger multinational trials to confirm its high detection rate with low false negativity. Citation Format: Sanjay Kumar Yadav, Bharath S, Sarada Khadka, Dhananjaya Sharma, Chandan Kumar Jha, Gaurav Agarwal, Manju Singh, Anurag Srivastava, Amit Goyal. A Systematic Review and Meta-analysis of Diagnostic Performance of Fluorescein Guided Sentinel Lymph Node Biopsy in Early Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-27-10.

Blood miRNAs as Potential Diagnostic Biomarkers for Chronic Obstructive Pulmonary Disease: A Meta-Analysis.

Investigate the efficacy of blood microRNAs (miRNAs) as diagnostic biomarkers for Chronic Obstructive Pulmonary Disease (COPD). We conducted a comprehensive search in English and Chinese databases, selecting studies based on predetermined criteria. Diagnostic parameters like summarized sensitivity (SSEN), summarized specificity (SSPE), summarized positive likelihood ratio (SPLR), summarized negative likelihood ratio (SNLR), and diagnostic odds ratio (DOR), and area under the curve (AUC) of the summary receiver operating characteristic (SROC) curves were analyzed using a bivariate model. Each parameter was accompanied by a 95% confidence interval (CI). Eighteen high-quality studies were included. For diagnosing COPD with blood miRNAs, the SSEN was 0.83 (95% CI 0.76-0.89), SSPE 0.76 (95% CI 0.70-0.82), SPLR 3.50 (95% CI 2.66-4.60), SNLR 0.22 (95% CI 0.15-0.33), DOR 15.72 (95% CI 8.58-28.77), and AUC 0.86 (95% CI 0.82-0.88). In acute exacerbations, SSEN was 0.85 (95% CI 0.76-0.91), SSPE 0.80 (95% CI 0.73-0.86), SPLR 4.26 (95% CI 3.05-5.95), SNLR 0.19 (95% CI 0.12-0.30), DOR 22.29 (95% CI 11.47-43.33), and AUC 0.89 (95% CI 0.86-0.91). Blood miRNAs demonstrate significant accuracy in diagnosing COPD, both in general and during acute exacerbations, suggesting their potential as reliable biomarkers.

Diagnostic Accuracy of Transthoracic Echocardiography for Acute Type A Aortic Syndrome: A Systematic Review and Meta-Analysis

Transthoracic echocardiography (TTE) is currently recognized as the potential first-line imaging test for patients with suspected acute type A aortic syndrome (AAAS). Direct TTE sign for detecting AAAS is positive if there is an intimal flap separating two aortic lumens or aortic wall thickening seen in the ascending aorta. Indirect TTE sign indicates high-risk features of AAAS, such as aortic root dilatation, pericardial effusion, and aortic regurgitation. Our aim is to summarize the existing clinical evidence regarding the diagnostic accuracy of TTE and to evaluate its potential role in the management of patients with suspected AAAS. We included prospective or retrospective diagnostic cohort studies, written in any language, that specifically focused on using TTE to diagnose AAAS from databases such as PubMed, EMBASE, MEDLINE, and the Cochrane Library. The pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio [1], and hierarchical summary receiver-operating characteristic (HSROC) curve were calculated for TTE in diagnosing AAAS. We applied Quality Assessment of Diagnostic Accuracy (QUADAS-2) tool and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) quality assessment criteria. Ten studies (2886 patients) were included in the meta-analysis. The pooled sensitivity and specificity of direct TTE signs were 58% (95% CI, 38-76%) and 94% (95% CI, 89-97%). For any TTE signs, the pooled sensitivity and specificity were 91% (95% CI, 85-94%) and 74% (95% CI, 61-84%). The diagnostic accuracy of direct TTE signs was significantly higher than that of any TTE signs, as measured by the area under the HSROC curve [0.95 (95% CI, 0.92-0.96) vs. 0.87 (95% CI, 0.84-0.90)] in four studies. Our study suggests that TTE could serve as the initial imaging test for patients with suspected AAAS. Given its high specificity, the presence of direct TTE signs may indicate AAAS, whereas the absence of any TTE signs, combined with low clinical suspicion, could suggest a lower likelihood of AAAS.

Predictive value of the Ranson and BISAP scoring systems for the severity and prognosis of acute pancreatitis: A systematic review and meta-analysis.

To systematically assess and compare the predictive value of the Ranson and Bedside Index of Severity in Acute Pancreatitis (BISAP) scoring systems for the severity and prognosis of acute pancreatitis (AP). PubMed, Embase, Cochrane Library, and Web of Science were systematically searched until February 15, 2023. Outcomes in this analysis included severity and prognosis [mortality, organ failure, pancreatic necrosis, and intensive care unit (ICU) admission]. The revised Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool was used to evaluate the quality of diagnostic accuracy studies. The threshold effect was evaluated for each outcome. The sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and the area under the summary receiver operating characteristic (SROC) curve (AUC) as well as 95% confidence intervals (CI) were calculated. The DeLong test was used for AUC comparisons. For the outcome evaluated by over 9 studies, publication bias was assessed using the Deeks' funnel plot asymmetry test. Totally 17 studies of 5476 AP patients were included. For severity, the pooled sensitivity of the Ranson and BISAP was 0.95 (95%CI: 0.87, 0.98) and 0.67 (95%CI: 0.27, 0.92); the pooled specificity of the Ranson and BISAP was 0.74 (0.52, 0.88) and 0.95 (95%CI: 0.85, 0.98); the pooled AUC of the Ranson and BISAP was 0.95 (95%CI: 0.93, 0.97) and 0.94 (95%CI: 0.92, 0.96) (P = 0.480). For mortality, the pooled sensitivity of the Ranson and BISAP was 0.89 (95%CI: 0.73, 0.96) and 0.77 (95%CI: 0.58, 0.89); the pooled specificity of the Ranson and BISAP was 0.79 (95%CI: 0.68, 0.87) and 0.90 (95%CI: 0.86, 0.93); the pooled AUC of the Ranson and BISAP was 0.91 (95%CI: 0.88, 0.93) and 0.92 (95%CI: 0.90, 0.94) (P = 0.480). For organ failure, the pooled sensitivity of the Ranson and BISAP was 0.84 (95%CI: 0.76, 0.90) and 0.78 (95%CI: 0.60, 0.90); the pooled specificity of the Ranson and BISAP was 0.84 (95%CI: 0.63, 0.94) and 0.90 (95%CI: 0.72, 0.97); the pooled AUC of the Ranson and BISAP was 0.86 (95%CI: 0.82, 0.88) and 0.90 (95%CI: 0.87, 0.93) (P = 0.110). For pancreatic necrosis, the pooled sensitivity of the Ranson and BISAP was 0.63 (95%CI: 0.35, 0.84) and 0.63 (95%CI: 0.23, 0.90); the pooled specificity of the Ranson and BISAP was 0.90 (95%CI: 0.77, 0.96) and 0.93 (95%CI: 0.89, 0.96); the pooled AUC of the Ranson and BISAP was 0.87 (95%CI: 0.84, 0.90) and 0.93 (95%CI: 0.91, 0.95) (P = 0.001). For ICU admission, the pooled sensitivity of the Ranson and BISAP was 0.86 (95%CI: 0.77, 0.92) and 0.63 (95%CI: 0.52, 0.73); the pooled specificity of the Ranson and BISAP was 0.58 (95%CI: 0.55, 0.61) and 0.84 (95%CI: 0.81, 0.86); the pooled AUC of the Ranson and BISAP was 0.92 (95%CI: 0.81, 1.00) and 0.86 (95%CI: 0.67, 1.00) (P = 0.592). The Ranson score was an applicable tool for predicting severity and prognosis of AP patients with reliable diagnostic accuracy in resource and time-limited settings. Future large-scale studies are needed to verify the findings.

Efficiency of endoscopic artificial intelligence in the diagnosis of early esophageal cancer.

The accuracy of artificial intelligence (AI) and experts in diagnosing early esophageal cancer (EC) and its infiltration depth was summarized and analyzed, thus identifying the advantages of AI over traditional manual diagnosis, with a view to more accurately assisting doctors in evaluating the patients' conditions and improving their cure and survival rates. The PubMed, EMBASE, Cochrane, Google, and CNKI databases were searched for relevant literature related to AI diagnosis of early EC and its invasion depth published before August 2023. Summary analysis of pooled sensitivity, specificity, summary receiver operating characteristics (SROC) and area under the curve (AUC) of AI in diagnosing early EC were performed, and Review Manager and Stata were adopted for data analysis. A total of 19 studies were enrolled with a low to moderate total risk of bias. The pooled sensitivity of AI for diagnosing early EC was markedly higher than that of novices and comparable to that of endoscopists. Moreover, AI predicted early EC with markedly higher AUCs than novices and experts (0.93 vs. 0.74 vs. 0.89). In addition, pooled sensitivity and specificity in the diagnosis of invasion depth in early EC were higher than that of experts, with AUCs of 0.97 and 0.92, respectively. AI-assistance can diagnose early EC and its infiltration depth more accurately, which can help in its early intervention and the customization of personalized treatment plans. Therefore, AI systems have great potential in the early diagnosis of EC.

Diagnostic accuracy of artificial intelligence assisted clinical imaging in the detection of oral potentially malignant disorders and oral cancer: a systematic review and meta-analysis.

The objective of this study is to examine the application of artificial intelligence (AI) algorithms in detecting oral potentially malignant disorders (OPMD) and oral cancerous lesions, and to evaluate the accuracy variations among different imaging tools employed in these diagnostic processes. A systematic search was conducted in four databases: Embase, Web of Science, PubMed, and Scopus. The inclusion criteria included studies using machine learning algorithms to provide diagnostic information on specific oral lesions, prospective or retrospective design, and inclusion of OPMD. Sensitivity and specificity analyses were also required. Forest plots were generated to display overall diagnostic odds ratio (DOR), sensitivity, specificity, negative predictive values, and summary receiver operating characteristic (SROC) curves. Meta-regression analysis was conducted to examine potential differences among different imaging tools. The overall DOR for AI-based screening of OPMD and oral mucosal cancerous lesions from normal mucosa was 68.438 (95% CI= [39.484-118.623], I2 =86%). The area under the SROC curve was 0.938, indicating excellent diagnostic performance. AI-assisted screening showed a sensitivity of 89.9% (95% CI= [0.866-0.925]; I2 =81%), specificity of 89.2% (95% CI= [0.851-0.922], I2 =79%), and a high negative predictive value of 89.5% (95% CI= [0.851-0.927], I2 =96%). Meta-regression analysis revealed no significant difference among the three image tools. After generating a GOSH plot, the DOR was calculated to be 49.30, and the area under the SROC curve was 0.877. Additionally, sensitivity, specificity, and negative predictive value were 90.5% (95% CI [0.873-0.929], I2 =4%), 87.0% (95% CI [0.813-0.912], I2 =49%) and 90.1% (95% CI [0.860-0.931], I2 =57%), respectively. Subgroup analysis showed that clinical photography had the highest diagnostic accuracy. AI-based detection using clinical photography shows a high DOR and is easily accessible in the current era with billions of phone subscribers globally. This indicates that there is significant potential for AI to enhance the diagnostic capabilities of general practitioners to the level of specialists by utilizing clinical photographs, without the need for expensive specialized imaging equipment.

The Role of Contrast-Enhanced Ultrasound in the Differential Diagnosis of Malignant and Benign Subpleural Lung Lesions.

Background: The application of transthoracic contrast-enhanced ultrasound (CEUS) to the study of peripheral lung lesions is still a topic of debate. The main objective of this review was to evaluate the diagnostic accuracy of CEUS in the diagnosis of malignant subpleural pulmonary consolidations and, therefore, differentiate them from benign ones. Methods: Papers published before December 2023 were detected through a search of PubMed, Cochrane library, and Embase. The pooled specificity and sensitivity, summary receiver operating characteristic (SROC) curve and diagnostic odds ratio (DOR) were used. Results: CEUS is characterized by a pooled sensitivity of 0.95 (95% CI: 0.93-0.97) and a pooled specificity of 0.93 (95% CI: 0.90-0.95) in differentiating benign and malignant subpleural lung diseases; the AUC of SROC was 0.97. Homogeneous CE was characterized by a pooled sensitivity of 0.43 (95% CI: 0.40-0.45) and the pooled specificity of 0.49 (95% CI: 0.46-0.52). Non-homogeneous CE displayed a pooled sensitivity of 0.57 (95% CI: 0.55-0.60) and a pooled specificity of 0.51 (95% CI: 0.48-0.54). The lack of CE displayed a pooled sensitivity of 0.01 (95% CI: 0.00-0.06) and a pooled specificity of 0.76 (95% CI: 0.64-0.85). Marked CE displayed a pooled sensitivity of 0.41 (95% CI: 0.37-0.44) and a pooled specificity of 0.54 (95% CI: 0.50-0.58). Non-marked CE displayed a pooled sensitivity of 0.59 (95% CI: 0.56-0.63) and a pooled specificity of 0.46 (95% CI: 0.42-0.50). The early AT displayed a pooled sensitivity of 0.04 (95% CI: 0.02-0.08) and a pooled specificity of 0.83 (95% CI: 0.77-0.87). The early wash out displayed a pooled sensitivity of 0.61 (95% CI: 0.48-0.72) and a pooled specificity of 0.98 (95% CI: 0.92-1.00). The delayed wash out displayed a pooled sensitivity of 0.15 (95% CI: 0.10-0.20) and a pooled specificity of 0.69 (95% CI: 0.62-0.75). Conclusions: CEUS is characterized by excellent diagnostic accuracy for the diagnosis of the malignancy of subpleural lung lesions. By separately analyzing the CEUS findings, the diagnostic accuracy values are considerably lower and not significant in some cases. The simultaneous evaluation of multiple CEUS features allows us to reach an excellent diagnostic accuracy. Non-homogeneous CE with early wash out are the most indicative features of malignancy of a lung lesion.