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We aimed to assess the performance of Ag-RDT and RT-qPCR with regard to detecting infectious SARS-CoV-2 in cell cultures, as their diagnostic test accuracy (DTA) compared to virus isolation remains largely unknown. We searched three databases up to 15 December 2021 for DTA studies. The bivariate model was used to synthesise the estimates. Risk of bias was assessed using QUADAS-2/C. Twenty studies (2605 respiratory samples) using cell culture and at least one molecular test were identified. All studies were at high or unclear risk of bias in at least one domain. Three comparative DTA studies reported results on Ag-RDT and RT-qPCR against cell culture. Two studies evaluated RT-qPCR against cell culture only. Fifteen studies evaluated Ag-RDT against cell culture as reference standard in RT-qPCR-positive samples. For Ag-RDT, summary sensitivity was 93% (95% CI 78; 98%) and specificity 87% (95% CI 70; 95%). For RT-qPCR, summary sensitivity (continuity-corrected) was 98% (95% CI 95; 99%) and specificity 45% (95% CI 28; 63%). In studies relying on RT-qPCR-positive subsamples (n = 15), the summary sensitivity of Ag-RDT was 93% (95% CI 92; 93%) and specificity 63% (95% CI 63; 63%). Ag-RDT show moderately high sensitivity, detecting most but not all samples demonstrated to be infectious based on virus isolation. Although RT-qPCR exhibits high sensitivity across studies, its low specificity to indicate infectivity raises the question of its general superiority in all clinical settings. Study findings should be interpreted with caution due to the risk of bias, heterogeneity and the imperfect reference standard for infectivity.
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COVID-19 , SARS-CoV-2 , Sensibilidad y Especificidad , Humanos , SARS-CoV-2/aislamiento & purificación , SARS-CoV-2/genética , SARS-CoV-2/patogenicidad , COVID-19/diagnóstico , COVID-19/virología , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/métodos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/normas , Técnicas de Cultivo de Célula/métodos , Prueba de COVID-19/métodos , Prueba de Ácido Nucleico para COVID-19/métodos , Prueba de Diagnóstico RápidoRESUMEN
Background: Advanced diagnostic bronchoscopy targeting the lung periphery has developed at an accelerated pace over the last two decades, whereas evidence to support introduction of innovative technologies has been variable and deficient. A major gap relates to variable reporting of diagnostic yield, in addition to limited comparative studies. Objectives: To develop a research framework to standardize the evaluation of advanced diagnostic bronchoscopy techniques for peripheral lung lesions. Specifically, we aimed for consensus on a robust definition of diagnostic yield, and we propose potential study designs at various stages of technology development. Methods: Panel members were selected for their diverse expertise. Workgroup meetings were conducted in virtual or hybrid format. The cochairs subsequently developed summary statements, with voting proceeding according to a modified Delphi process. The statement was cosponsored by the American Thoracic Society and the American College of Chest Physicians. Results: Consensus was reached on 15 statements on the definition of diagnostic outcomes and study designs. A strict definition of diagnostic yield should be used, and studies should be reported according to the STARD (Standards for Reporting Diagnostic Accuracy Studies) guidelines. Clinical or radiographic follow-up may be incorporated into the reference standard definition but should not be used to calculate diagnostic yield from the procedural encounter. Methodologically robust comparative studies, with incorporation of patient-reported outcomes, are needed to adequately assess and validate minimally invasive diagnostic technologies targeting the lung periphery. Conclusions: This American Thoracic Society/American College of Chest Physicians statement aims to provide a research framework that allows greater standardization of device validation efforts through clearly defined diagnostic outcomes and robust study designs. High-quality studies, both industry and publicly funded, can support subsequent health economic analyses and guide implementation decisions in various healthcare settings.
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Neoplasias Pulmonares , Médicos , Humanos , Neoplasias Pulmonares/diagnóstico , Consenso , Broncoscopía/métodos , Técnica Delphi , Pulmón/patología , Atención Dirigida al PacienteRESUMEN
BACKGROUND: Abbreviated breast MRI (FAST MRI) is being introduced into clinical practice to screen women with mammographically dense breasts or with a personal history of breast cancer. This study aimed to optimise diagnostic accuracy through the adaptation of interpretation-training. METHODS: A FAST MRI interpretation-training programme (short presentations and guided hands-on workstation teaching) was adapted to provide additional training during the assessment task (interpretation of an enriched dataset of 125 FAST MRI scans) by giving readers feedback about the true outcome of each scan immediately after each scan was interpreted (formative assessment). Reader interaction with the FAST MRI scans used developed software (RiViewer) that recorded reader opinions and reading times for each scan. The training programme was additionally adapted for remote e-learning delivery. STUDY DESIGN: Prospective, blinded interpretation of an enriched dataset by multiple readers. RESULTS: 43 mammogram readers completed the training, 22 who interpreted breast MRI in their clinical role (Group 1) and 21 who did not (Group 2). Overall sensitivity was 83% (95%CI 81-84%; 1994/2408), specificity 94% (95%CI 93-94%; 7806/8338), readers' agreement with the true outcome kappa = 0.75 (95%CI 0.74-0.77) and diagnostic odds ratio = 70.67 (95%CI 61.59-81.09). Group 1 readers showed similar sensitivity (84%) to Group 2 (82% p = 0.14), but slightly higher specificity (94% v. 93%, p = 0.001). Concordance with the ground truth increased significantly with the number of FAST MRI scans read through the formative assessment task (p = 0.002) but by differing amounts depending on whether or not a reader had previously attended FAST MRI training (interaction p = 0.02). Concordance with the ground truth was significantly associated with reading batch size (p = 0.02), tending to worsen when more than 50 scans were read per batch. Group 1 took a median of 56 seconds (range 8-47,466) to interpret each FAST MRI scan compared with 78 (14-22,830, p < 0.0001) for Group 2. CONCLUSIONS: Provision of immediate feedback to mammogram readers during the assessment test set reading task increased specificity for FAST MRI interpretation and achieved high diagnostic accuracy. Optimal reading-batch size for FAST MRI was 50 reads per batch. Trial registration (25/09/2019): ISRCTN16624917.
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Neoplasias de la Mama , Curva de Aprendizaje , Imagen por Resonancia Magnética , Mamografía , Humanos , Femenino , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/diagnóstico , Imagen por Resonancia Magnética/métodos , Mamografía/métodos , Persona de Mediana Edad , Detección Precoz del Cáncer/métodos , Estudios Prospectivos , Anciano , Sensibilidad y Especificidad , Interpretación de Imagen Asistida por Computador/métodos , Mama/diagnóstico por imagen , Mama/patologíaRESUMEN
A growing proportion of head and neck cancer (HNC), especially oropharyngeal cancer (OPC), is caused by human papillomavirus (HPV). There are several markers for HPV-driven HNC, one being HPV early antigen serology. We aimed to investigate the diagnostic accuracy of HPV serology and its performance across patient characteristics. Data from the VOYAGER consortium was used, which comprises five studies on HNC from North America and Europe. Diagnostic accuracy, that is, sensitivity, specificity, Cohen's kappa and correctly classified proportions of HPV16 E6 serology, was assessed for OPC and other HNC using p16INK4a immunohistochemistry (p16), HPV in situ hybridization (ISH) and HPV PCR as reference methods. Stratified analyses were performed for variables including age, sex, smoking and alcohol use, to test the robustness of diagnostic accuracy. A risk-factor analysis based on serology was conducted, comparing HPV-driven to non-HPV-driven OPC. Overall, HPV serology had a sensitivity of 86.8% (95% CI 85.1-88.3) and specificity of 91.2% (95% CI 88.6-93.4) for HPV-driven OPC using p16 as a reference method. In stratified analyses, diagnostic accuracy remained consistent across sex and different age groups. Sensitivity was lower for heavy smokers (77.7%), OPC without lymph node involvement (74.4%) and the ARCAGE study (66.7%), while specificity decreased for cases with <10 pack-years (72.1%). The risk-factor model included study, year of diagnosis, age, sex, BMI, alcohol use, pack-years, TNM-T and TNM-N stage. HPV serology is a robust biomarker for HPV-driven OPC, and its diagnostic accuracy is independent of age and sex. Future research is suggested on the influence of smoking on HPV antibody levels.
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Neoplasias de Cabeza y Cuello , Neoplasias Orofaríngeas , Infecciones por Papillomavirus , Humanos , Papillomavirus Humano 16 , Virus del Papiloma Humano , Neoplasias de Cabeza y Cuello/diagnósticoRESUMEN
BACKGROUND & AIMS: Agile scores, including liver stiffness measurements (LSM) and routine clinical/laboratory biomarkers, have been developed for advanced fibrosis (F≥3) and cirrhosis (F4), respectively, in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). We independently validated the diagnostic accuracy of these scores in MASLD, alcohol-related liver disease (ALD) and chronic hepatitis B or C (CHB/C) and assessed them in clinical algorithms with FIB-4 and LSM. METHODS: We included 4,243 patients (MASLD: 912, ALD: 386, CHB: 597, CHC: 2,348) with LSM, liver biopsy and laboratory tests within 6 months. FIB-4, Agile 3+ and Agile 4 scores were calculated. RESULTS: For F≥3, the diagnostic accuracy of Agile 3+ and LSM were similar in MASLD (AUC: 0.86 vs. 0.86, p = 0.831) and ALD (0.92 vs. 0.94, p = 0.123). For cirrhosis, Agile 4 was similar to LSM in MASLD (0.89 vs. 0.90, p = 0.412) and ALD (0.94 vs. 0.95, p = 0.513). Agile 3+/4 performed worse than LSM in CHB/C. Using predefined dual thresholds of 90% sensitivity/specificity, correct classification rates in MASLD were 66% vs. 61% using Agile 3+ vs. LS dual cut-offs and 71% vs. 67% in ALD, respectively. When using Agile 3+ or LSM as a second step after FIB-4 >1.3, correct classification rates were higher with Agile 3+ than LSM, both for MASLD (75% vs. 71%) and ALD (76% vs. 72%), with fewer indeterminate results. Positive agreement of LSM and Agile 3+/4 significantly increased the specificity of a diagnosis of advanced fibrosis/cirrhosis. CONCLUSION: Agile 3+ and Agile 4 have equal diagnostic accuracy with LSM in both MASLD and ALD but result in fewer indeterminate results. Sequential use of FIB-4 and Agile 3+/4 or concurrent Agile 3+/4 and LSM can be used to further optimize F≥3 diagnosis. IMPACT AND IMPLICATIONS: As of today, it is accepted that there will be no single non-invasive test or an isolated cut-off for identifying patients with advanced chronic liver disease. Here, we confirmed that Agile 3+ and Agile 4 scores are useful alternatives to simple liver stiffness measurement in diagnosing advanced fibrosis/cirrhosis in steatotic liver disease, but they do not perform as well in chronic viral hepatitis. Agile scores can help optimize the diagnosis of advanced fibrosis/cirrhosis in a dual cut-off strategy by reducing the number of indeterminate results either alone or in a sequential strategy after FIB-4. The combination of Agile scores and liver stiffness measurement can further increase our confidence in a positive diagnosis of advanced fibrosis/cirrhosis. These novel combination strategies can be useful tools to predict the likelihood of advanced stages of liver disease with the highest possible accuracy in a secondary/tertiary healthcare setting.
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Mass spectrometry-based proteomic technique has become indispensable in current exploration of complex and dynamic biological processes. Instrument development has largely ensured the effective production of proteomic data, which necessitates commensurate advances in statistical framework to discover the optimal proteomic signature. Current framework mainly emphasizes the generalizability of the identified signature in predicting the independent data but neglects the reproducibility among signatures identified from independently repeated trials on different sub-dataset. These problems seriously restricted the wide application of the proteomic technique in molecular biology and other related directions. Thus, it is crucial to enable the generalizable and reproducible discovery of the proteomic signature with the subsequent indication of phenotype association. However, no such tool has been developed and available yet. Herein, an online tool, POSREG, was therefore constructed to identify the optimal signature for a set of proteomic data. It works by (i) identifying the proteomic signature of good reproducibility and aggregating them to ensemble feature ranking by ensemble learning, (ii) assessing the generalizability of ensemble feature ranking to acquire the optimal signature and (iii) indicating the phenotype association of discovered signature. POSREG is unique in its capacity of discovering the proteomic signature by simultaneously optimizing its reproducibility and generalizability. It is now accessible free of charge without any registration or login requirement at https://idrblab.org/posreg/.
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Proteómica , Proteómica/métodos , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: Prompt and precise differential diagnosis of biliary atresia (BA) among cholestatic patients is of great importance. Matrix metalloproteinase-7 (MMP-7) holds great promise as a diagnostic marker for BA. This study aimed to investigate the accuracy of age-specific serum MMP-7 for discriminating BA from other cholestatic pediatric patients. METHODS: This was a single center diagnostic accuracy and validation study including both retrospective and prospective cohorts. Serum MMP-7 concentrations were measured using an ELISA kit, the trajectory of which with age was investigated in a healthy infants cohort aged 0 to 365 days without hepatobiliary diseases (n = 284). Clinical BA diagnosis was based on intraoperative cholangiography and subsequent histological examinations. The diagnostic accuracy of age-specific cutoffs of serum MMP-7 were assessed in a retrospective cohort of cholestatic patients (n = 318, with 172 BA) and validated in a prospective cohort (n = 687, including 395 BA). RESULTS: The MMP-7 concentration declines non-linearly with age, showing higher levels in healthy neonates as well as higher cutoff value in neonatal cholestasis. The area under the ROC curve (AUROC) was 0.967 (95% confidence interval [CI]: 0.946-0.988) for the retrospective cohort, and the cutoff of 18 ng/mL yielded 93.0% (95%CI: 88.1-96.3%), 93.8% (95%CI: 88.6-97.1%), 94.7% (95%CI: 90.1-97.5%), and 91.9% (95%CI: 86.4-95.8%) for sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), respectively. The performance of MMP-7 was successfully validated in the larger prospective cohort, resulting in a diagnostic sensitivity of 95.9% (379/395; 95% CI: 93.5-97.7%), a specificity of 87.3% (255/292; 95% CI: 83.0-90.9%), a PPV of 91.1% (379/416; 95% CI: 87.9-93.7%), and a NPV of 94.1% (255/271; 95% CI: 90.6-96.6%), respectively. Besides, higher cutoff value of 28.1 ng/mL achieved the best sensitivity, specificity, PPV, and NPV for infants aged 0-30 days, which was 86.4% (95% CI: 75.0-94.0%), 95.5% (95% CI: 77.2-99.9%), 98.1% (95% CI: 89.7-100%), and 72.4% (95% CI: 52.8-87.3%), respectively. CONCLUSIONS: The serum MMP-7 is accurate and reliable in differentiating BA from non-BA cholestasis, showing its potential application in the diagnostic algorithm for BA and significant role in the future research regarding pathogenesis of BA.
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Atresia Biliar , Metaloproteinasa 7 de la Matriz , Curva ROC , Humanos , Atresia Biliar/sangre , Atresia Biliar/diagnóstico , Metaloproteinasa 7 de la Matriz/sangre , Lactante , Masculino , Femenino , Recién Nacido , Reproducibilidad de los Resultados , Estudios Retrospectivos , Diagnóstico Diferencial , Preescolar , Colestasis/sangre , Colestasis/diagnóstico , Estudios ProspectivosRESUMEN
BACKGROUND: Lymph node metastasis is a critical prognostic factor for patients with gastric carcinoma (GC). Sentinel lymph node (SLN) mapping has the potential to identify the initial site of draining lymph node metastasis and reduce the extent of surgical lymphadenectomy. This study aimed to evaluate the diagnostic accuracy of SLN mapping in GC. METHODS: The study enrolled 129 GC patients undergoing total or partial gastrectomy with D2 lymphadenectomy and indocyanine green fluorescence-guided SLN mapping. The primary outcomes were the negative predictive value (NPV) and sensitivity of SLN mapping. The secondary outcomes were clinicopathologic factors associated with SLN mapping accuracy and successful SLN mapping. RESULTS: The SLN detection rate in this study was 86.8 %. The study had an overall NPV of 83.1 % and an overall sensitivity of 65.8 %. The NPV was found to be significantly higher in the patients with no lymphovascular invasion (LVI) than in those with LVI (96.0 % vs 59.3 %; p < 0.001) and in the patients whose pathologic T (pT) stage lower than 3 than in those whose T stage was 3 or higher (92.0 % vs 66.7 %; p = 0.009). The sensitivity of SLN mapping was 50 % in the patients with no LVI and 33 % in the patients with a pT stage lower than 3. CONCLUSION: The study results showed that for patients with early-stage GC with no LVI, negative SLN findings may represent a potential additive predictor indicating the absence of regional LN metastasis. However, given the low sensitivity rates noted, further research is needed to identify specific patient populations that may benefit from SLN mapping in GC.
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BACKGROUND: Endobronchial ultrasound (EBUS) and cone-beam computed tomography-derived augmented fluoroscopy (CBCT-AF) are utilized for the diagnosis of peripheral pulmonary lesions (PPLs). Combining them with transbronchial cryobiopsy (TBC) can provide sufficient tissue for genetic analysis. However, cryoprobes of different sizes have varying degrees of flexibility, which can affect their ability to access the target bronchus and potentially impact the accuracy. The aim of this study was to compare the diagnostic efficacy of cryoprobes of varying sizes in CBCT-AF and EBUS for the diagnosis of PPLs. METHODS: Patients who underwent endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB) and TBC combined with CBCT-AF for PPLs diagnosis between January 2021 and May 2022 were included. Propensity score matching and competing-risks regression were utilized for data analysis. Primary outcome was the diagnostic accuracy of TBC. RESULTS: A total of 284 patients underwent TBC, with 172 using a 1.7-mm cryoprobe (1.7 group) and 112 using a 1.1-mm cryoprobe (1.1 group). Finally, we included 99 paired patients following propensity score matching. The diagnostic accuracy of TBC was higher in the 1.1 group (80.8% vs. 69.7%, P = 0.050), with a similar rate of complications. Subgroup analysis also revealed that the 1.1 group had better accuracy when PPLs were located in the upper lobe (85.2% vs. 66.1%, P = 0.020), when PPLs were smaller than 20 mm (78.8% vs. 48.8%, P = 0.008), and when intra-procedural CBCT was needed to be used (79.5% vs. 42.3%, P = 0.001). TBC obtained larger specimens than TBB in both groups. There is still a trend of larger sample size obtained in the 1.7 group, but there is no statistically different between our two study groups (40.8 mm2 vs. 22.0 mm2, P = 0.283). CONCLUSIONS: The combination of TBC with CBCT-AF and EBUS is effective in diagnosing PPLs, and a thin cryoprobe is preferred when the PPLs located in difficult areas.
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Enfermedades Pulmonares , Neoplasias Pulmonares , Humanos , Enfermedades Pulmonares/diagnóstico , Broncoscopía , Biopsia Guiada por Imagen , Neoplasias Pulmonares/patología , Biopsia , Tomografía Computarizada de Haz Cónico , Fluoroscopía , Estudios RetrospectivosRESUMEN
PURPOSE: To compare the diagnostic accuracy and detection rates of PET/MRI with [68Ga]Ga-PSMA-11 and [68Ga]Ga-M2 in patients with biochemical recurrence of prostate cancer (PCa). METHODS: Sixty patients were enrolled in this prospective single-center phase II clinical trial from June 2020 to October 2022. Forty-four/60 completed all study examinations and were available at follow-up (median: 22.8 months, range: 6-31.5 months). Two nuclear medicine physicians analyzed PET images and two radiologists interpreted MRI; images were then re-examined to produce an integrated PET/MRI report for both [68Ga]Ga-PSMA-11 and [68Ga]Ga-RM2 examinations. A composite reference standard including histological specimens, response to treatment, and conventional imaging gathered during follow-up was used to validate imaging findings. Detection rates, accuracy, sensitivity, specificity, positive, and negative predictive value were assessed. McNemar's test was used to compare sensitivity and specificity on a per-patient base and detection rate on a per-region base. Prostate bed, locoregional lymph nodes, non-skeletal distant metastases, and bone metastases were considered. p-value significance was defined below the 0.05 level after correction for multiple testing. RESULTS: Patients' median age was 69.8 years (interquartile range (IQR): 61.8-75.1) and median PSA level at time of imaging was 0.53 ng/mL (IQR: 0.33-2.04). During follow-up, evidence of recurrence was observed in 31/44 patients. Combining MRI with [68Ga]Ga-PSMA-11 PET and [68Ga]Ga-RM2 PET resulted in sensitivity = 100% and 93.5% and specificity of 69.2% and 69.2%, respectively. When considering the individual imaging modalities, [68Ga]Ga-RM2 PET showed lower sensitivity compared to [68Ga]Ga-PSMA-11 PET and MRI (61.3% vs 83.9% and 87.1%, p = 0.046 and 0.043, respectively), while specificity was comparable among the imaging modalities (100% vs 84.6% and 69.2%, p = 0.479 and 0.134, respectively). CONCLUSION: This study brings further evidence on the utility of fully hybrid PET/MRI for disease characterization in patients with biochemically recurrent PCa. Imaging with [68Ga]Ga-PSMA-11 PET showed high sensitivity, while the utility of [68Ga]Ga-RM2 PET in absence of a simultaneous whole-body/multiparametric MRI remains to be determined.
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Isótopos de Galio , Radioisótopos de Galio , Neoplasias de la Próstata , Masculino , Humanos , Anciano , Estudios Prospectivos , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Imagen por Resonancia Magnética , Tomografía Computarizada por Tomografía de Emisión de Positrones , Ácido EdéticoRESUMEN
BACKGROUND: Lung cancer (LC), characterized by high incidence and mortality rates, presents a significant challenge in oncology. Despite advancements in treatments, early detection remains crucial for improving patient outcomes. The accuracy of screening for LC by detecting volatile organic compounds (VOCs) in exhaled breath remains to be determined. METHODS: Our systematic review, following PRISMA guidelines and analyzing data from 25 studies up to October 1, 2023, evaluates the effectiveness of different techniques in detecting VOCs. We registered the review protocol with PROSPERO and performed a systematic search in PubMed, EMBASE and Web of Science. Reviewers screened the studies' titles/abstracts and full texts, and used QUADAS-2 tool for quality assessment. Then performed meta-analysis by adopting a bivariate model for sensitivity and specificity. RESULTS: This study explores the potential of VOCs in exhaled breath as biomarkers for LC screening, offering a non-invasive alternative to traditional methods. In all studies, exhaled VOCs discriminated LC from controls. The meta-analysis indicates an integrated sensitivity and specificity of 85% and 86%, respectively, with an AUC of 0.93 for VOC detection. We also conducted a systematic analysis of the source of the substance with the highest frequency of occurrence in the tested compounds. Despite the promising results, variability in study quality and methodological challenges highlight the need for further research. CONCLUSION: This review emphasizes the potential of VOC analysis as a cost-effective, non-invasive screening tool for early LC detection, which could significantly improve patient management and survival rates.
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Pruebas Respiratorias , Detección Precoz del Cáncer , Neoplasias Pulmonares , Compuestos Orgánicos Volátiles , Humanos , Compuestos Orgánicos Volátiles/análisis , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/metabolismo , Detección Precoz del Cáncer/métodos , Pruebas Respiratorias/métodos , Espiración , Sensibilidad y Especificidad , Biomarcadores de Tumor/análisis , Biomarcadores de Tumor/metabolismoRESUMEN
BACKGROUND: Anxiety in pregnancy and after giving birth (the perinatal period) is highly prevalent but under-recognised. Robust methods of assessing perinatal anxiety are essential for services to identify and treat women appropriately. AIMS: To determine which assessment measures are most psychometrically robust and effective at identifying women with perinatal anxiety (primary objective) and depression (secondary objective). METHOD: We conducted a prospective longitudinal cohort study of 2243 women who completed five measures of anxiety and depression (Generalized Anxiety Disorder scale (GAD) two- and seven-item versions; Whooley questions; Clinical Outcomes in Routine Evaluation (CORE-10); and Stirling Antenatal Anxiety Scale (SAAS)) during pregnancy (15 weeks, 22 weeks and 31 weeks) and after birth (6 weeks). To assess diagnostic accuracy a sample of 403 participants completed modules of the Mini-International Neuropsychiatric Interview (MINI). RESULTS: The best diagnostic accuracy for anxiety was shown by the CORE-10 and SAAS. The best diagnostic accuracy for depression was shown by the CORE-10, SAAS and Whooley questions, although the SAAS had lower specificity. The same cut-off scores for each measure were optimal for identifying anxiety or depression (SAAS ≥9; CORE-10 ≥9; Whooley ≥1). All measures were psychometrically robust, with good internal consistency, convergent validity and unidimensional factor structure. CONCLUSIONS: This study identified robust and effective methods of assessing perinatal anxiety and depression. We recommend using the CORE-10 or SAAS to assess perinatal anxiety and the CORE-10 or Whooley questions to assess depression. The GAD-2 and GAD-7 did not perform as well as other measures and optimal cut-offs were lower than currently recommended.
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Trastornos de Ansiedad , Ansiedad , Femenino , Embarazo , Humanos , Estudios Prospectivos , Estudios Longitudinales , Trastornos de Ansiedad/diagnóstico , Trastornos de Ansiedad/psicología , Ansiedad/diagnóstico , Escalas de Valoración Psiquiátrica , PsicometríaRESUMEN
Carotid plaque composition represents one of the main risk factors of future ischemic stroke. MRI provides excellent soft tissue contrast that can distinguish plaque characteristics. Our objective was to analyze the diagnostic accuracy of MRI imaging in the detection of carotid plaque characteristics compared to histology in patients with symptomatic and asymptomatic carotid atherosclerosis through a systematic review. After prospective registration in PROSPERO (ID CRD42022329690), Medline Ovid, Embase.com, Cochrane Library, and Web of Science Core were searched without any search limitation up to May 27, 2022 to identify eligible articles. Of the 8168 studies, 53 (37 × 1.5 T MRI, 17 × 3 T MRI) evaluated MRI accuracy in the detection of 13 specific carotid plaque characteristics in 169 comparisons. MRI demonstrated high diagnostic accuracy for detection of calcification (3 T MRI: mean sensitivity 92%/mean specificity 90%; 1.5 T MRI: mean sensitivity 81%/mean specificity 91%), fibrous cap (1.5 T: 89%/87%), unstable plaque (1.5 T: 89%/87%), intraplaque hemorrhage (1.5 T: 86%/88%), and lipid-rich necrotic core (1.5 T: 89%/79%). MRI also proved to have a high level of tissue discrimination for the carotid plaque characteristics investigated, allowing potentially for a better risk assessment and follow-up of patients who may benefit from more aggressive treatments. These results emphasize the role of MRI as the first-line imaging modality for comprehensive assessment of carotid plaque morphology, particularly for unstable plaque. EVIDENCE LEVEL: 2 TECHNICAL EFFICACY: Stage 2.
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OBJECTIVES: To compare Uromonitor® (U-Monitor Lda, Porto, Portugal), a multitarget DNA assay that detects mutated proto-oncogenes (telomerase reverse transcriptase [TERT], fibroblast growth factor receptor 3 [FGFR-3], Kirsten rat sarcoma viral oncogene homologue [KRAS]), with urine cytology in the urine-based diagnosis of urothelial carcinoma of the bladder (UCB) within a multicentre real-world setting. PATIENTS AND METHODS: This multicentre, prospective, double-blind study was conducted across four German urological centres from 2019 to 2024. We evaluated the diagnostic performance of Uromonitor compared to urine cytology in a cohort of patients with UCB and in healthy controls within a real-world setting. Sensitivity, specificity, positive-predictive value (PPV), negative-predictive value (NPV), and accuracy of the tests were measured, in addition to multivariate analyses to assess the ability of individual proto-oncogene mutations in detecting UCB. The biometric sample size was designed to achieve a 10% difference in sensitivity. RESULTS: Patients with UCB comprised 63.7% (339/532) of the study group. Uromonitor showed a sensitivity, specificity, PPV, NPV, accuracy, and an area-under-the-curve of 49.3%, 93.3%, 92.8%, 51.1%, 65.2%, and 0.713%, respectively. These metrics did not demonstrate statistical superiority over urine cytology in terms of sensitivity (44.6%; P = 0.316). Moreover, the comparison of additional test parameters, as well as the comparison within various sensitivity analyses, yielded no significant disparity between the two urinary tests. Multivariate logistic regression underscored the significant predictive value of a positive Uromonitor for detecting UCB (odds ratio [OR] 9.03; P < 0.001). Furthermore, mutations in TERT and FGFR-3 were independently associated with high odds of UCB detection (OR 13.30 and 7.04, respectively), while KRAS mutations did not exhibit predictive capability. CONCLUSION: Despite its innovative approach, Uromonitor fell short of confirming the superior results anticipated from previous studies in this real-world setting. The search for an optimal urine-based biomarker for detecting and monitoring UCB remains ongoing. Results from this study highlight the complexity of developing non-invasive diagnostic tools and emphasise the importance of continued research efforts to refine these technologies.
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BACKGROUND: Urinary tract infections (UTIs) have been one of the most common bacterial infections in clinical practice worldwide. Artificial intelligence (AI) and machine learning (ML) based algorithms have been increasingly applied in UTI case identification and prediction. However, the overall performance of AI/ML algorithms in identifying and predicting UTI has not been evaluated. The purpose of this paper is to quantitatively evaluate the application value of AI/ML in identifying and predicting UTI cases. METHODS: MEDLINE, EMBASE, Web of Science, and PubMed databases were systematically searched for articles published up to December 31, 2023. Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2) and Prediction Model Risk of Bias Assessment Tool (PROBAST) were used to assess the risk of bias. Study characteristics and detailed algorithm information were extracted. Pooled sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) were synthesized using a bivariate mix-effects model. Meta-regression and subgroup analysis were conducted to test the source of heterogeneity. RESULTS: In total, 11 studies with 14 AI/ML models were included in the final meta-analysis. The overall pooled AUC was 0.89 (95%CI 0.86-0.92). Additionally, the pooled Sen, Spe, PLR, NLR, and DOR were 0.78 (95%CI 0.71-0.84), 0.89 (95%CI 0.83-0.93), 6.99 (95%CI 4.38-11.14), 0.25 (95%CI 0.18-0.34) and 28.07 (95%CI 14.27-55.20), respectively. The results of meta-regression suggested that reference standard definitions might be the source of heterogeneity. CONCLUSION: AI/ML algorithms appear to be promising to help clinicians detect and identify patients at high risk of UTIs. However, further studies are demanded to evaluate the application value of AI/ML more thoroughly.
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Inteligencia Artificial , Aprendizaje Automático , Infecciones Urinarias , Infecciones Urinarias/diagnóstico , Humanos , Valor Predictivo de las PruebasRESUMEN
OBJECTIVES: To perform a comprehensive within-subject image quality analysis of abdominal CT examinations reconstructed with DLIR and to evaluate diagnostic accuracy compared to the routinely applied adaptive statistical iterative reconstruction (ASiR-V) algorithm. MATERIALS AND METHODS: Oncologic patients were prospectively enrolled and underwent contrast-enhanced CT. Images were reconstructed with DLIR with three intensity levels of reconstruction (high, medium, and low) and ASiR-V at strength levels from 10 to 100% with a 10% interval. Three radiologists characterized the lesions and two readers assessed diagnostic accuracy and calculated signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), figure of merit (FOM), and subjective image quality, the latter with a 5-point Likert scale. RESULTS: Fifty patients (mean age: 70 ± 10 years, 23 men) were enrolled and 130 liver lesions (105 benign lesions, 25 metastases) were identified. DLIR_H achieved the highest SNR and CNR, comparable to ASiR-V 100% (p ≥ .051). DLIR_M returned the highest subjective image quality (score: 5; IQR: 4-5; p ≤ .001) and significant median increase (29%) in FOM (p < .001). Differences in detection were identified only for lesions ≤ 0.5 cm: 32/33 lesions were detected with DLIR_M and 26 lesions were detected with ASiR-V 50% (p = .031). Lesion accuracy of was 93.8% (95% CI: 88.1, 97.3; 122 of 130 lesions) for DLIR and 87.7% (95% CI: 80.8, 92.8; 114 of 130 lesions) for ASiR-V 50%. CONCLUSIONS: DLIR yields superior image quality and provides higher diagnostic accuracy compared to ASiR-V in the assessment of hypovascular liver lesions, in particular for lesions ≤ 0.5 cm. CLINICAL RELEVANCE STATEMENT: Deep learning image reconstruction algorithm demonstrates higher diagnostic accuracy compared to iterative reconstruction in the identification of hypovascular liver lesions, especially for lesions ≤ 0.5 cm. KEY POINTS: ⢠Iterative reconstruction algorithm impacts image texture, with negative effects on diagnostic capabilities. ⢠Medium-strength deep learning image reconstruction algorithm outperforms iterative reconstruction in the diagnostic accuracy of ≤ 0.5 cm hypovascular liver lesions (93.9% vs 78.8%), also granting higher objective and subjective image quality. ⢠Deep learning image reconstruction algorithm can be safely implemented in routine abdominal CT protocols in place of iterative reconstruction.
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Aprendizaje Profundo , Neoplasias Hepáticas , Masculino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Interpretación de Imagen Radiográfica Asistida por Computador/métodos , Dosis de Radiación , Tomografía Computarizada por Rayos X/métodos , Algoritmos , Procesamiento de Imagen Asistido por Computador , Neoplasias Hepáticas/diagnóstico por imagenRESUMEN
OBJECTIVES: This study aimed to explore the role of CT in septic patients presenting to the emergency department (ED). MATERIALS AND METHODS: We performed a retrospective secondary analysis of 192 septic patients from a prospective observational study, i.e., the "LIFE POC" study. Sepsis was diagnosed in accordance with the Sepsis-3 definition. Clinical and radiological data were collected from the hospital administration and radiological systems. Information on mortality and morbidity was collected. Time-to-CT between CT scan and sepsis diagnosis (ttCTsd) was calculated. Diagnostic accuracy was assessed with the final sepsis source as reference standard. The reference standard was established through the treating team of the patient based on all available clinical, imaging, and microbiological data. RESULTS: Sixty-two of 192 patients underwent a CT examination for sepsis focus detection. The final septic source was identified by CT in 69.4% (n = 43). CT detected septic foci with 81.1% sensitivity (95% CI, 68.0-90.6%) and 55.6% specificity (95% CI, 21.2-86.3%). Patients with short versus long ttCTsd did not differ in terms of mortality (16.1%, n = 5 vs 9.7, n = 3; p = 0.449), length of hospital stay (median 16 d, IQR 9 d 12 h-23 d 18 h vs median 13 d, IQR 10 d 00 h-24 d 00 h; p = 0.863), or duration of intensive care (median 3d 12 h, IQR 2 d 6 h-7 d 18 h vs median 5d, IQR 2 d-11 d; p = 0.800). CONCLUSIONS: Our findings show a high sensitivity of CT in ED patients with sepsis, confirming its relevance in guiding treatment decisions. The low specificity suggests that a negative CT requires further ancillary diagnostic tests for focus detection. The timing of CT did not affect morbidity or mortality outcomes. CLINICAL RELEVANCE STATEMENT: In patients with sepsis who present to the ED, CT can be used to identify infectious foci on the basis of clinical suspicion, but should not be used as a rule-out test. Scientific evidence for the optimal timing of CT beyond clinical decision-making is currently missing, as potential mortality benefits are clouded by differences in clinical severity at the time of ED presentation. KEY POINTS: ⢠In patients with sepsis who present to the ED, CT for focus identification has a high sensitivity and can thereby be valuable for patient management. ⢠As the specificity is considerably lower, a thorough microbiological assessment is important in these cases. ⢠The timing of CT did not affect morbidity and mortality outcomes in this study, which might be due to variability in clinical severity at the time of ED presentation.
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OBJECTIVES: To conduct an intrapatient comparison of ultra-low-dose computed tomography (ULDCT) and standard-of-care-dose CT (SDCT) of the chest in terms of the diagnostic accuracy of ULDCT and intrareader agreement in patients with post-COVID conditions. METHODS: We prospectively included 153 consecutive patients with post-COVID-19 conditions. All participants received an SDCT and an additional ULDCT scan of the chest. SDCTs were performed with standard imaging parameters and ULDCTs at a fixed tube voltage of 100 kVp (with tin filtration), 50 ref. mAs (dose modulation active), and iterative reconstruction algorithm level 5 of 5. All CT scans were separately evaluated by four radiologists for the presence of lung changes and their consistency with post-COVID lung abnormalities. Radiation dose parameters and the sensitivity, specificity, and accuracy of ULDCT were calculated. RESULTS: Of the 153 included patients (mean age 47.4 ± 15.3 years; 48.4% women), 45 (29.4%) showed post-COVID lung abnormalities. In those 45 patients, the most frequently detected CT patterns were ground-glass opacities (100.0%), reticulations (43.5%), and parenchymal bands (37.0%). The accuracy, sensitivity, and specificity of ULDCT compared to SDCT for the detection of post-COVID lung abnormalities were 92.6, 87.2, and 94.9%, respectively. The median total dose length product (DLP) of ULDCTs was less than one-tenth of the radiation dose of our SDCTs (12.6 mGy*cm [9.9; 15.5] vs. 132.1 mGy*cm [103.9; 160.2]; p < 0.001). CONCLUSION: ULDCT of the chest offers high accuracy in the detection of post-COVID lung abnormalities compared to an SDCT scan at less than one-tenth the radiation dose, corresponding to only twice the dose of a standard chest radiograph in two views. CLINICAL RELEVANCE STATEMENT: Ultra-low-dose CT of the chest may provide a favorable, radiation-saving alternative to standard-dose CT in the long-term follow-up of the large patient cohort of post-COVID-19 patients.
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BACKGROUND AND PURPOSE: Timely prehospital stroke recognition was explored in the Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) by implementation of stroke education for paramedics and use of the National Institutes of Health Stroke Scale (NIHSS) through a mobile application. The study tested triage and facilitated communication between paramedics and stroke physicians. To complement the quantitative results of the clinical trial, a qualitative approach was used to identify factors that influence triage decisions and diagnostic accuracy in prehospital stroke recognition experienced by paramedics and stroke physicians. METHOD: Semi-structured qualitative individual interviews were performed following an interview guide. Informants were recruited from the enrolled paramedics and stroke physicians who participated in the ParaNASPP trial from Oslo University Hospital. Interviews were audio recorded, transcribed verbatim and approached inductively using the principles of thematic analysis. RESULTS: Fourteen interviews were conducted, with seven paramedics and seven stroke physicians. Across both groups two overarching themes were identified related to triage decisions and diagnostic accuracy in prehospital stroke recognition: prehospital NIHSS reliably improves clinical assessment and communication quality; overtriage is widely accepted whilst undertriage is not. CONCLUSION: Paramedics and stroke physicians described how prehospital NIHSS improved communication quality and reliably improved prehospital clinical assessment. The qualitative results support a rationale of an application algorithm to decide which NIHSS items should prompt immediate prenotification rather than a complete NIHSS as default.
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Servicios Médicos de Urgencia , Accidente Cerebrovascular , Humanos , Servicios Médicos de Urgencia/métodos , Paramédico , Investigación Cualitativa , Accidente Cerebrovascular/diagnóstico , Triaje/métodos , Estados UnidosRESUMEN
BACKGROUND AND PURPOSE: National quality registries for stroke care operate under the assumption that the included patients are correctly diagnosed. We aimed to validate the clinical diagnosis of spontaneous intracerebral hemorrhage (ICH) in Riksstroke (RS) by evaluating radiological data from a large, unselected ICH population. METHODS: We conducted a retrospective, multicenter study including all ICH patients registered in RS between 2016 and 2020 residing in Skåne County in Sweden (1.41 million inhabitants). Radiological data from first imaging were evaluated for the presence of spontaneous ICH. Other types of bleeds were registered if a spontaneous ICH was not identified on imaging. The radiological evaluation was independently performed by one radiology fellow and one senior neuroradiologist. RESULTS: Between 2016 and 2020, 1784 ICH cases were registered in RS, of which 1655 (92.8%) had a radiological diagnosis consistent with spontaneous ICH. In the 129 (7.2%) remaining cases, the radiological diagnosis was instead traumatic bleed (n = 80), subarachnoid hemorrhage (n = 15), brain tumor bleed (n = 14), ischemic lesion with hemorrhagic transformation (n = 14), ischemic lesion (n = 3), or no bleed at all (n = 3). There was a higher degree of incorrect coding in the older age groups. CONCLUSION: At radiological evaluation, 92.8% of ICH diagnoses in RS were consistent with spontaneous ICH, yielding a high rate of agreement that strengthens the validity of the diagnostic accuracy in the register, justifying the use of high coverage quality register data for epidemiological purposes. The most common coding error was traumatic bleeds that were classified as spontaneous ICH.