Diagnostic OR Research Articles

Efficacy of Endosonographic Procedures in Mediastinal Restaging of Lung Cancer After Neoadjuvant Therapy: A Systematic Review and Diagnostic Accuracy Meta-Analysis

The optimal modality for restaging the mediastinum following neoadjuvant therapy for lung cancer remains unclear. Surgical methods are currently considered the reference standard. The present study evaluates the role of endosonographic techniques for mediastinal restaging in lung cancer. A systematic review of PubMed and Embase databases was performed to identify studies using endoscopic ultrasound, endobronchial ultrasound, or a combination of the two for mediastinal restaging following induction therapy for stage III lung cancer. The quality of the included studies was assessed by using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. The accuracy of endosonography was analyzed by calculating the sensitivity, specificity, likelihood ratio, and diagnostic OR for each study and pooling the results by using a bivariate model. Heterogeneity and publication bias were assessed. Potential causes of heterogeneity were explored by using sensitivity analysis and meta-regression. Ten studies (N= 574) were included. The pooled sensitivity, specificity, diagnostic OR, and positive and negative likelihood ratios were 67%(95%CI, 56-77), 99%(95%CI, 89-100), 157, 52.0, and 0.33, respectively. No complications were reported. Significant heterogeneity was observed for the outcome of sensitivity. Sensitivity analysis identified several factors accounting for heterogeneity, including study design and risk of bias. The sensitivity of the endosonographic procedure was also linked to the prevalence of N2 disease on meta-regression. Funnel plot showed publication bias, but this finding was not evident on statistical tests. Endosonographic procedures are safe and highly specific in mediastinal restaging of lung cancer.

CircRNAs as biomarkers of cancer: a meta-analysis

BackgroundThe expression of circular RNA (circRNA) may affect tumor progression. However, there have been no systemic meta-analysis for cancer diagnosis by using circRNAs in clinical till now. Herein, we aimed to collect and examined all the evidence on the potential role of circRNA as novel biomarker in human cancers.MethodsA comprehensive search strategy was used to search relevant literatures in the databases of PubMed, Embase, and the Web of Science from 2015 to August 2017. The correlation between circRNA expression and the diagnostic accuracy of tumor markers was analyzed. The methodological quality of each study was assessed by quality assessment for the diagnostic accuracies of the eligible studies (QUADAS-2). Statistical analysis was performed by applying the STATA (version 12.0) software.ResultsThe present meta-analysis included 1752 patients with circRNA expression data of tumor and paired adjacent non-tumorous tissues from 17 publications (19 studies). The pooled sensitivity, specificity, positive likelihood ratios (PLR), negative likelihood ratios (NLR), and diagnostic OR (DOR) with their 95% confidential intervals (95%CIs), and AUC values were 0.72 (0.67–0.76), 0.74 (0.69–0.78), 2.80 (2.40–3.10), 0.38 (0.33–0.44), 7.00 (6.00–9.00), and 0.79, respectively. Subgroup analyses showed that the expression of circRNA in tissues of hepatocellular carcinoma (HCC) group was more prone to be detected than other tumor types, with a high values of the specificity, DOR, and AUC.ConclusionscircRNAs might be suitable as diagnostic biomarkers for tumors, especially in HCC diagnosis. Further prospective studies on the diagnostic value of circRNAs from the different tumors are needed in the future.

Performance of the quick Sequential (sepsis-related) Organ Failure Assessment score as a prognostic tool in infected patients outside the intensive care unit: a systematic review and meta-analysis

BackgroundThe usefulness of the quick Sequential (Sepsis-related) Organ Failure Assessment (qSOFA) score in providing bedside criteria for early prediction of poor outcomes in patients with suspected infection remains controversial. We investigated the prognostic performance of a positive qSOFA score outside the intensive care unit (ICU) compared with positive systemic inflammatory response syndrome (SIRS) criteria.MethodsA systematic literature search was performed using MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. Data were pooled on the basis of sensitivity, specificity, and diagnostic OR. Overall test performance was summarized using a hierarchical summary ROC and the AUC. Meta-regression analysis was used to identify potential sources of bias.ResultsWe identified 23 studies with a total of 146,551 patients. When predicting in-hospital mortality in our meta-analysis, we identified pooled sensitivities of 0.51 for a positive qSOFA score and 0.86 for positive SIRS criteria, as well as pooled specificities of 0.83 for a positive qSOFA score and 0.29 for positive SIRS criteria. Discrimination for in-hospital mortality had similar AUCs between the two tools (0.74 vs. 0.71; P = 0.816). Using meta-regression analysis, an overall mortality rate ≥ 10% and timing of qSOFA score measurement could be significant sources of heterogeneity. For predicting acute organ dysfunction, although the AUC for a positive qSOFA score was higher than that for positive SIRS criteria (0.87 vs. 0.76; P < 0.001), the pooled sensitivity of positive qSOFA score was very low (0.47). In addition, a positive qSOFA score tended to be inferior to positive SIRS criteria in predicting ICU admission (0.63 vs. 0.78; P = 0.121).ConclusionsA positive qSOFA score had high specificity outside the ICU in early detection of in-hospital mortality, acute organ dysfunction, and ICU admission, but low sensitivity may have limitations as a predictive tool for adverse outcomes. Because between-study heterogeneity was highly represented among the studies, our results should be interpreted with caution.

EVIDENCE REQUIRED BY HEALTH TECHNOLOGY ASSESSMENT AND REIMBURSEMENT BODIES EVALUATING DIAGNOSTIC OR PROGNOSTIC ALGORITHMS THAT INCLUDE OMICS DATA

Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes. This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017. Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders. Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.

A Simple Symptom Score for Acute Human Immunodeficiency Virus Infection in a San Diego Community-Based Screening Program

Treatment of acute human immunodeficiency virus (HIV) infection (AHI) decreases transmission and preserves immune function, but AHI diagnosis remains resource intensive. Risk-based scores predictive for AHI have been described for high-risk groups; however, symptom-based scores could be more generalizable across populations. Adults who tested either positive for AHI (antibody-negative, HIV nucleic acid test [NAT] positive) or HIV NAT negative with the community-based San Diego Early Test HIV screening program were retrospectively randomized 2:1 into a derivation and validation set. In the former, symptoms significant for AHI in a multivariate logistic regression model were assigned a score value (the odds ratio [OR] rounded to the nearest integer). The score was assessed in the validation set using receiver operating characteristics and areas under the curve (AUC). An optimal cutoff score was found using the Youden index. Of 998 participants (including 261 non-men who have sex with men [MSM]), 113 had AHI (including 4 non-MSM). Compared to HIV-negative cases, AHI cases reported more symptoms (median, 4 vs 0; P < .01). Fever, myalgia, and weight loss were significantly associated with AHI in the multivariate model and corresponded to 11, 8, and 4 score points, respectively. The summed score yielded an AUC of 0.85 (95% confidence interval [CI], .77-.93). A score of ≥11 was 72% sensitive and 96% specific (diagnostic OR, 70.27). A 3-symptom score accurately predicted AHI in a community-based screening program and may inform allocation of resources in settings that do not routinely screen for AHI.

Are there researcher allegiance effects in diagnostic validation studies of the PHQ-9? A systematic review and meta-analysis

ObjectivesTo investigate whether an authorship effect is found that leads to better performance in studies conducted by the original developers of the Patient Health Questionnaire (PHQ-9) (allegiant studies).DesignSystematic review with...

Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis

Deciding the optimal timing for extubation in patients who are mechanically ventilated can be challenging, and traditional weaning predictor tools are not very accurate. The aim of this systematic review and meta-analysis was to assess the accuracy of lung and diaphragm ultrasound for predicting weaning outcomes in critically ill adults. MEDLINE, the Cochrane Library, Web of Science, Scopus, LILACS, Teseo, Tesis Doctorales en Red, and OpenGrey were searched, and the bibliographies of relevant studies were reviewed. Two researchers independently selected studies that met the inclusion criteria and assessed study quality in accordance with the Quality Assessment of Diagnostic Accuracy Studies-2 tool. The summary receiver-operating characteristic curve and pooled diagnostic OR (DOR) were estimated by using a bivariate random effects analysis. Sources of heterogeneity were explored by using predefined subgroup analyses and bivariate meta-regression. Nineteen studies involving 1,071 people were included in the study. For diaphragm thickening fraction, the area under the summary receiver-operating characteristic curve was 0.87, and DOR was 21 (95%CI, 11-40). Regarding diaphragmatic excursion, pooled sensitivity was 75%(95%CI, 65-85); pooled specificity, 75%(95%CI, 60-85); and DOR, 10 (95%CI, 4-24). For lung ultrasound, the area under the summary receiver-operating characteristic curve was 0.77, and DOR was 38 (95%CI, 7-198). Based on bivariate meta-regression analysis, a significantly higher specificity for diaphragm thickening fraction and higher sensitivity for diaphragmatic excursion was detected in studies with applicability concerns. Lung and diaphragm ultrasound can help predict weaning outcome, but its accuracy may vary depending on the patient subpopulation.

Automated long-term EEG analysis to localize the epileptogenic zone.

SummaryObjectiveWe investigated the performance of automatic spike detection and subsequent electroencephalogram (EEG) source imaging to localize the epileptogenic zone (EZ) from long‐term EEG recorded during video‐EEG monitoring.MethodsIn 32 patients, spikes were automatically detected in the EEG and clustered according to their morphology. The two spike clusters with most single events in each patient were averaged and localized in the brain at the half‐rising time and peak of the spike using EEG source imaging. On the basis of the distance from the sources to the resection and the known patient outcome after surgery, the performance of the automated EEG analysis to localize the EZ was quantified.ResultsIn 28 out of the 32 patients, the automatically detected spike clusters corresponded with the reported interictal findings. The median distance to the resection in patients with Engel class I outcome was 6.5 and 15 mm for spike cluster 1 and 27 and 26 mm for cluster 2, at the peak and the half‐rising time of the spike, respectively. Spike occurrence (cluster 1 vs. cluster 2) and spike timing (peak vs. half‐rising) significantly influenced the distance to the resection (p < 0.05). For patients with Engel class II, III, and IV outcomes, the median distance increased to 36 and 36 mm for cluster 1. Localizing spike cluster 1 at the peak resulted in a sensitivity of 70% and specificity of 100%, positive prediction value (PPV) of 100%, and negative predictive value (NPV) of 53%. Including the results of spike cluster 2 led to an increased sensitivity of 79% NPV of 55% and diagnostic OR of 11.4, while the specificity dropped to 75% and the PPV to 90%.SignificanceWe showed that automated analysis of long‐term EEG recordings results in a high sensitivity and specificity to localize the epileptogenic focus.

Prevalencia de corioamnionitis histológica en pacientes con trabajo de parto pretérmino espontáneo. Popayán, Colombia, 2014–2016

Objetivo: determinar la prevalencia de la co­rioamnionitis histológica en gestantes con trabajo de parto pretérmino espontáneo, evaluar posibles factores de riesgo y la asociación con signos clínicos y paraclínicos.Materiales y métodos: estudio descriptivo de prevalencia, con análisis secundario exploratorio en gestantes con embarazo menor a 37 semanas de gestación, con parto espontáneo, en quienes se dispuso de sus placentas para estudio histopatoló­gico, durante un periodo de 2 años, en un hospital de alta complejidad en Popayán, Colombia. Se ex­cluyeron partos pretérmino secundarios. Muestreo consecutivo, con tamaño muestral de 166 gestantes; se midieron variables sociodemográficas, clínicas, de laboratorio e imágenes diagnósticas, y resultado histopatológico de la placenta. En el análisis se es­timó la prevalencia de periodo de corioamnionitis histológica. Se obtuvo la razón de prevalencias como medida de asociación y el OR diagnóstico (ORD) con su respectivo intervalo de confianza al 95 %.Resultados: en un periodo de 2 años se analizaron 160 gestantes y sus placentas, 110 placentas fueron reportadas como positivas para corioamnionitis his­tológica con una prevalencia de 68,75 % (IC 95 %: 61,49-76,00), esta fue más prevalente en gestaciones menores de 34 semanas (RP = 1,48; IC 95 %: 1,20-1,83). En cuanto a la asociación de los síntomas y signos se encontró asociación significativa con la fiebre (ORD = 4,7; IC 95 %: 1,05-21,09), la taqui­cardia materna (ORD = 4,22; IC 95 %: 1,81-9,81), la taquicardia fetal (ORD = 3,74; IC 95 %: 1,23-11,35), movimientos respiratorios ausentes (ORD = 5,16; IC 95 %: 1,43-18,60), lago de líquido amniótico menor a 2 cm (ORD = 5,67; IC 95 %: 1,24-25,98), y presencia de neutrofilia (ORD = 2,97; IC 95 %: 1,44-6,12).Conclusiones: la prevalencia de corioamnionitis histológica es del 67% en los partos pretérmino y varió en función de la edad gestacional.

Accuracy of testing for anti-Helicobacter pylori IgG in urine for H. pylori infection diagnosis: a systematic review and meta-analysis

ObjectivesThis meta-analysis aims to systematically measure the potential diagnostic value of anti-Helicobacter pylori IgG in urine for infection diagnosis, using all eligible studies published in English and Chinese languages.DesignThe random...

A Comprehensive Comparison of CT, MRI, Positron Emission Tomography or Positron Emission Tomography/CT, and Diffusion Weighted Imaging-MRI for Detecting the Lymph Nodes Metastases in Patients with Cervical Cancer: A Meta-Analysis Based on 67 Studies

Object: In recent times, many published papers reported the diagnostic performance of CT, MRI, positron emission tomography (PET) using 2-[¹⁸F] fluoro-2-deoxy-D-glucose (FDG) and diffusion-weighted magnetic resonance imaging (DW-MRI) for detecting the lymph nodes (LNs) metastases in patients with cervical cancer. This study is aimed at assessing and comparing the diagnostic value of those non-invasive modalities in detecting the LNs metastases in cervical cancer patients. Methods: Studies on the non-invasive modalities for the detection of metastatic LNs were searched in PubMed, Medline, Web of Science, Cochrane Library and Embase databases. Pooled positive likelihood ratios and negative likelihood ratios, diagnostic OR, area under curve (AUC), summary receiver operating characteristics were calculated as evaluation indices. Results: In region- or node-based analysis, the AUC of DWI-MRI (0.92) and PET or PET/CT (0.90) were better than CT (0.83), and the difference was significant (DWI-MRI vs. CT: Z = 4.61, p < 0.001; PET or PET/CT vs. CT: Z = 3.61, p = 0.001). Conclusion: Among the 4 non-invasive modalities, the PET or PET/CT has the highest specificity, and DWI-MRI has the highest sensitivity.

Validity of three methods for inmuno-diagnostic of neurocysticercosis: systematic review of the literature with meta-analysis 1960-2014

The screening of neurocysticercosis is complex and immunological methods have varying validity. To evaluate the validity of ELISA for antigen and antibody, and EITB for antibody in the screening of neurocysticercosis. Meta-analysis of diagnostic tests with an ex-ante protocol implemented in five databases with 15 search strategies, ensuring reproducibility in the selection and extraction of information. Sensitivity, specificity, likelihood ratios (LR), diagnostic odds ratio and ROC curve were estimated in MetaDiSc, and predictive values, and Youden index were estimated in Epidat. EITB presented sensitivity of 85.7% (95% CI 83.5-87.7), specificity 93.9% (95% CI = 92.7-95.0), PLR 19.6 (95% CI = 8,6-44.6), NLR 0.16 (95% CI = 0.12-0.21), OR diagnostic 136.2 (95% CI = 54.7-342.6) and area under the curve 0.926. In ELISA for antibody sensitivity was 87.5% (95% CI = 86.1-88.8), specificity 92.2% (95% CI = 91.4-93.0), PLR 11.3 (95% CI = 8.45-15.11), NLR 0.15 (95% CI = 0.13-0.18), diagnostic OR 87.4 (95% CI = 60.1-127.1) and area under the curve 0.950. ELISA for antigen showed low diagnostic validity. No differences were found in these parameters by sample, antigen or antibody type. ELISA for antibodies and EITB have a similar diagnostic value, detection of serum and CSF showed a similar validity.

Capnography for procedural sedation in the ED: a systematic review

IntroductionProcedural sedation and analgesia (PSA) is commonplace in the ED. Previous studies have identified capnography as a reliable indicator of PSA-induced respiratory depression. This review investigates the potential effect on...

Safety of the Manchester Triage System to Detect Critically Ill Children at the Emergency Department

To assess the safety of the Manchester Triage System in pediatric emergency care for children who require admission to the intensive care unit (ICU). Between 2006 and 2013, 50 062 consecutive emergency department visits of children younger than the age of 16 years were included. We determined the percentage of undertriage, defined as the proportion of children admitted to ICU triaged as low urgent according to the Manchester Triage System, and diagnostic performance measures, including sensitivity, specificity, and diagnostic OR. Characteristics of undertriaged patients were compared with correctly triaged patients. In a logistic regression model, risk factors for undertriage were determined. In total, 238 (28.7%) of the 830 children admitted to ICU during the study period were undertriaged. Sensitivity of high Manchester Triage System urgency levels to detect ICU admission was 71% (95% CI 68%-74%) and specificity 85% (95% CI 85%-85%). Severity of illness was lower in undertriaged children than correctly triaged children admitted to ICU. Risk factors for undertriage were age <3 months, medical presenting problem, comorbidity, referral by a medical specialist or emergency medical services, and presentation during the evening or night shift. The Manchester Triage System misclassifies a substantial number of children who require ICU admission. Modifications targeted at young children and children with a comorbid condition could possibly improve safety of the Manchester Triage System in pediatric emergency care.

Comparison of the diagnostic utility of physician-diagnosed with algorithm-defined stroke-associated pneumonia

ObjectiveDiagnosing stroke-associated pneumonia (SAP) is challenging and may result in inappropriate antibiotic use or confound research outcomes. This study evaluates the diagnostic accuracy of algorithm-defined versus physician-diagnosed SAP in 1088...

Accuracy of FENO for diagnosing asthma: a systematic review

BackgroundMeasurement of FENO might substitute bronchial provocation for diagnosing asthma. We aimed to investigate the diagnostic accuracy of FENO measurement compared with established reference standard.MethodsSystematic review and diagnostic meta-analysis. Data...

Study protocol—investigation of the Delirium Observation Screening Scale (DOSS) for the routine detection of delirium in the care home setting: a prospective cohort study

IntroductionDelirium is a common and distressing condition associated with frailty, dementia and comorbidity. These are common in long-term care settings. Residents in care homes are therefore at particular risk of...

Role of sTREM-1 in predicting mortality of infection: a systematic review and meta-analysis

ObjectivesSeveral studies have investigated the prognostic value of soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) in patients with infection. However, the result was controversial. Thus, the purpose of the...

Breslow thickness and (18)F-FDG PET-CT result in initial staging of cutaneous melanoma: Can a cut-off point be established?

To establish a Breslow Thickness (BT) cut-off point for indication of PET-CT of cutaneous melanoma in early stages and evaluate its prognostic value. Retrospective analysis of 347 PET-CT studies with diagnosis of melanoma, of which 108 were performed for initial staging. Thirty-one patients were excluded, and a final sample of 77 patients remained. A ROC curve analysis was performed to establish an optimal cut-off point. A survival analysis was performed, considering death assignable to melanoma as the main event, for the evaluation of its prognostic value. Forty-seven (61.04%) of all 77 patients selected were men, and 11 (14.29%) had a positive PET-CT result. Mean age was 65.17±15.00 years. The median BT in patients with a negative PET-CT result was 2.75 mm (IQR 1.83-4.50) and in the positive group 6.25 mm (IQR 5.40-7.50) (P=.0013). In the ROC curve analysis (AUC 0.804, SE 0.054), an optimal value of 5 mm BT with the following values was obtained: sensitivity 90.91%, specificity 78.79%, negative predictive value (NPV) 98.1%, positive predictive value (PPV) 41.7%, diagnostic OR 37.1, and accuracy 80.52%. Mean follow-up was 18.66±14,35 months, detecting 2/53 (3.77%) deaths in the BT<5 mm group, and 7/24 (29.17%) in the BT≥5 mm group. Survival curves between both groups were significantly different (P=.0013). A 5 mm cut-off point correctly distinguishes those patients with positive PET-CT from those with negative results in the early stages of cutaneous melanoma; therefore it could be included in initial staging of this subgroup of patients.

Breslow thickness and 18F-FDG PET/CT results in initial staging of cutaneous melanoma: Can a cut-off point be established?

AimTo establish a Breslow thickness (BT) cut-off point for indication of PET/CT of cutaneous melanoma in early stages and evaluate its prognostic value. Material and methodsRetrospective analysis of 347 PET/CT studies with diagnosis of melanoma, of which 108 were performed for initial staging. Thirty-one patients were excluded, and a final sample of 77 patients remained. A ROC curve analysis was performed to establish an optimal cut-off point. A survival analysis was performed, considering death assignable to melanoma as the main event, for the evaluation of its prognostic value. ResultsForty-seven (61.04%) of all 77 patients selected were men, and 11 (14.29%) had a positive PET/CT result. Mean age was 65.17±15.00 years. The median BT in patients with a negative PET/CT result was 2.75mm (IQR 1.83–4.50) and in the positive group 6.25mm (IQR 5.40–7.50) (p=0.0013). In the ROC curve analysis (AUC 0.804, SE 0.054), an optimal value of 5mm BT with the following values was obtained: sensitivity 90.91%, specificity 78.79%, negative predictive value (NPV) 98.1%, positive predictive value (PPV) 41.7%, diagnostic OR 37.1, and accuracy 80.52%. Mean follow-up was 18.66±14.35 months, detecting 2/53 (3.77%) deaths in the BT<5mm group, and 7/24 (29.17%) in the BT≥5mm group. Survival curves between both groups were significantly different (p=0.0013). ConclusionsA 5mm cut-off point correctly distinguishes those patients with positive PET/CT from those with negative results in the early stages of cutaneous melanoma; therefore it could be included in initial staging of this subgroup of patients.