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Hoong CWS, Sfeir JG, Drake MT, Broski SM. Gallium-68-DOTATATE PET/CT for phosphaturic mesenchymal tumor localization in suspected tumor-induced osteomalacia. JBMR Plus 2025; 9:ziaf040. [PMID: 40231307 PMCID: PMC11995880 DOI: 10.1093/jbmrpl/ziaf040] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/24/2024] [Revised: 02/14/2025] [Accepted: 02/26/2025] [Indexed: 04/16/2025] Open
Abstract
Gallium-68-DOTA-Tyr3-Octreotate (Ga-68-DOTATATE) positron emission tomography/computed tomography (PET/CT) has recently been shown to have utility for the localization of phosphaturic mesenchymal tumors (PMT) that cause tumor-induced osteomalacia (TIO), a rare renal phosphate-wasting disorder. The aim of this study was to evaluate the accuracy of Ga-68-DOTATATE PET/CT in localizing PMTs causing TIO and to compare its performance with other functional imaging modalities. Prospective recruitment and retrospective chart review of 30 patients with suspected TIO and evaluation with Ga-68-DOTATATE PET/CT between 2017 and 2023 were conducted at a tertiary medical center. True positive (TP) lesions were defined by histological confirmation of PMT. There were 22 TP lesions identified among 18 patients, with a mean SUVmax of 16.8 (±10.9). Sensitivity, specificity, and accuracy of Ga-68-DOTATATE PET/CT were 85.7%, 77.8%, and 83.3% on patient-based analysis, and 84.6%, 56.3%, and 73.8% on lesion-based analysis. Lesions such as subacute fractures, parathyroid adenomas, thymus uptake, vertebral hemangiomas, bone enchondromas, liver hemangiomas, and avascular necrosis were some of the pitfalls in interpretation. Ga-68-DOTATATE PET/CT led to a significant impact on clinical management in 24 (80%) of patients. The presence of DOTATATE-avid fractures was significantly associated with a localizing scan on univariable (OR 15.0, 95% CI 2.80-110, p = .001) and multivariable analysis (OR 9.45, 95% CI 1.33-98.4, p = .003). Ga-68-DOTATATE PET/CT has good accuracy for the localization of TIO, with superior sensitivity compared to F-18-FDG PET/CT. This significantly impacted clinical treatment decisions. Although DOTATATE-avid fractures may be a source of false positives, they may also indicate a higher probability of a localizing study.
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Affiliation(s)
- Caroline W S Hoong
- Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Medicine, Mayo Clinic, Rochester, MN 55905, United States
- Department of Endocrinology, Woodlands Health, National Healthcare Group, 737628, Singapore
| | - Jad G Sfeir
- Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Medicine, Mayo Clinic, Rochester, MN 55905, United States
- Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN 55905, United States
- Division of Geriatric Medicine and Gerontology, Department of Medicine, Mayo Clinic, Rochester, MN 55905, United States
| | - Matthew T Drake
- Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Medicine, Mayo Clinic, Rochester, MN 55905, United States
- Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN 55905, United States
| | - Stephen M Broski
- Department of Radiology, Mayo Clinic, Rochester, MN 55905, United States
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2
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Maury A, Benzakoun J, Bani-Sadr A, Ter Schiphorst A, Reiner P, Hosseini H, Seners P, Pallud J, Oppenheim C, Calvet D, Charidimou A, Varlet P, Turc G, Baron JC. Diagnostic Accuracy of Finger-Like Projections and Subarachnoid Hemorrhage for Cerebral Amyloid Angiopathy: Pathological Validation From Lobar Hematoma Evacuation or Brain Biopsy. Stroke 2025. [PMID: 40270245 DOI: 10.1161/strokeaha.124.050159] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/21/2024] [Revised: 03/24/2025] [Accepted: 04/09/2025] [Indexed: 04/25/2025]
Abstract
BACKGROUND Diagnosing cerebral amyloid angiopathy (CAA) after spontaneous lobar intracerebral hemorrhage has significant clinical implications. A previous postmortem study found that the presence of both subarachnoid hemorrhage (SAH) and hematoma finger-like projections (FLP) on acute-stage computed tomography strongly rules in CAA. In the present study, we assessed the diagnostic value of these imaging markers against histopathologic diagnosis in less severe presentations. METHODS This retrospective (2002-2022) multicenter study included patients aged ≥45 years with lobar intracerebral hemorrhage of unknown cause, for whom acute-stage computed tomography or magnetic resonance imaging and neuropathological samples from hematoma evacuation or biopsy were available. Centralized consensus reading (2 raters) of imaging and neuropathological data (including Aβ immunohistochemistry) were performed. Analysis was restricted to samples containing at least 10 vessels. The diagnostic performance was evaluated against the neuropathological reference, that is, CAA/no CAA. RESULTS We analyzed data from 66 patients (age, 65±9 years; men, 33%; hematoma volume, 45±26 mL; death within 1 year, 14%) from 6 French centers. Neuropathological material included samples from hematoma evacuation (n=48) and biopsy (n=18). CAA was present in 38 patients (58%), and FLP and SAH were observed in 29 (44%) and 50 (76%) patients, respectively. FLP had a sensitivity of 0.58 (95% CI, 0.41-0.74) and a specificity of 0.74 (95% CI, 0.54-0.89) for the diagnosis of CAA. SAH demonstrated a high sensitivity of 0.92 (95% CI, 0.78-0.98; negative predictive value=0.80 [0.52-0.96]) but moderate specificity of 0.43 (95% CI, 0.24-0.63). The combined presence of FLP and SAH had a specificity of 0.54 (95% CI, 0.37-0.71) and a sensitivity of 0.79 (95% CI, 0.59-0.92). CONCLUSIONS This study is the first to evaluate the diagnostic performance of FLP and SAH with histopathologic reference in nonautopsied patients. The results suggest these markers have lower diagnostic performance than previously reported in severe hematomas leading to early death. However, the high sensitivity of SAH suggests its potential clinical utility in ruling out CAA when absent.
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Affiliation(s)
- Alexandra Maury
- Department of Neurology, GHU Paris Psychiatrie et Neurosciences, Université Paris Cité, France. (A.M., D.C., G.T., J.-C.B.)
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
| | - Joseph Benzakoun
- Department of Imaging, GHU Paris Psychiatrie et Neurosciences, Université Paris Cité, France. (J.B., C.O.)
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
| | - Alexandre Bani-Sadr
- Department of Neuroradiology, East Group Hospital, Hospices Civils de Lyon, CREATIS, CNRS UMR 5220, INSERM U 5220, Claude-Bernard Lyon I University, France (A.B.-S.)
| | - Adrien Ter Schiphorst
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
- Department of Neurology, CHRU Gui de Chauliac, Montpellier, France (A.S.)
| | - Peggy Reiner
- Department of Neurology, Hôpital Lariboisière, APHP Nord, INSERM UMR-S 1144, FHU NeuroVasc, Paris, France (P.R.)
| | - Hassan Hosseini
- Department of Neurology, H. Mondor University Hospital, Créteil, France (H.H.)
| | - Pierre Seners
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
- Department of Neurology, Rothschild Foundation Hospital, Paris, France (P.S.)
| | - Johan Pallud
- Department of Neurosurgery, GHU Paris Psychiatrie et Neurosciences, Université Paris Cité, France. (J.P.)
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
| | - Catherine Oppenheim
- Department of Imaging, GHU Paris Psychiatrie et Neurosciences, Université Paris Cité, France. (J.B., C.O.)
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
| | - David Calvet
- Department of Neurology, GHU Paris Psychiatrie et Neurosciences, Université Paris Cité, France. (A.M., D.C., G.T., J.-C.B.)
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
| | - Andreas Charidimou
- Department of Neurology, Boston University Chobanian & Avedisian School of Medicine, MA (A.C.)
| | - Pascale Varlet
- and Department of Neuropathology, GHU Paris Psychiatrie et Neurosciences, Université Paris Cité, France. (P.V.)
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
| | - Guillaume Turc
- Department of Neurology, GHU Paris Psychiatrie et Neurosciences, Université Paris Cité, France. (A.M., D.C., G.T., J.-C.B.)
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
| | - Jean-Claude Baron
- Department of Neurology, GHU Paris Psychiatrie et Neurosciences, Université Paris Cité, France. (A.M., D.C., G.T., J.-C.B.)
- Université Paris Cité, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, France (A.M., J.B., A.S., P.S., J.P., C.O., D.C., P.V., G.T., J.-C.B.)
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3
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de Alencar JN, Monteiro JAM, Furtado JT, Sacre RC, Guerra CB, Knoblauch WS, Felicioni SP, Scheffer MK, De Marchi MFN, Franchini KG. ECG Criteria and Diagnostic Score for Right Atrial Disease in Children: The CHILDHEART Study. Pediatr Cardiol 2025:10.1007/s00246-025-03858-w. [PMID: 40251461 DOI: 10.1007/s00246-025-03858-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/01/2024] [Accepted: 11/20/2024] [Indexed: 04/20/2025]
Abstract
To develop a novel diagnostic electrocardiogram (ECG) score to improve the early detection of right atrial disease (RAD) in pediatric patients with congenital heart disease (CHD). We conducted a retrospective case-control study involving 219 pediatric patients aged 0 to 14 years with confirmed CHD and 1,418 controls without congenital disease. The ECG data were analyzed to identify specific criteria predictive of RAD. Receiver operating characteristic (ROC) curves and multivariate analyses were used to refine and develop a diagnostic score. Key variables assessed included right bundle branch block (RBBB), a pure R wave in V1, an initial q wave in V1, an S wave greater than the R wave in V6, and RV1 + SV6 ≥ 18 mm. The diagnostic score demonstrated robust performance. In children under 3 years, the score achieved an area under the curve (AUC) of 0.826 (95% CI: 0.779-0.879). A score of ≥ 2 had a sensitivity of 63.2% and specificity of 89.7%. For children aged 3 years and older, the score had an AUC of 0.817 (95% CI: 0.764-0.871), with a sensitivity of 48.67% and specificity of 98.1%. The CHILDHEART diagnostic score provides a practical and reliable tool for identifying RAD in pediatric patients using a standard 12-lead ECG. This score offers significant potential for early diagnosis and improved management of RAD in children, especially in clinical settings where advanced imaging modalities may not be readily available.
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Affiliation(s)
- José Nunes de Alencar
- Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
- Research Division, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
| | | | - Julia Teuber Furtado
- Pediatric Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
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Biswas J, Datta M, Kar K, Mitra D, Jyothi L, Maitra A. Role of serum high-sensitive C-reactive protein to predict severity of pre-eclampsia in a high-population resource-poor country: a prospective observational study. J Rural Med 2025; 20:71-77. [PMID: 40182158 PMCID: PMC11962192 DOI: 10.2185/jrm.2024-031] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/09/2024] [Accepted: 11/06/2024] [Indexed: 04/05/2025] Open
Abstract
Objective To determine the role of high-sensitive C-reactive protein (hsCRP) in predicting the severity of preeclampsia in a high-population, resource-poor country. Patients and Methods This prospective cohort study was conducted at the Department of Obstetrics and Gynaecology of Calcutta National Medical College, India, from March 2021 to September 2022. A total of 180 participants were divided into three equal groups: patients with severe preeclampsia and non-severe preeclampsia and healthy pregnant women. Results The levels of the biomarkers hsCRP and uric acid differed significantly between women with preeclampsia and healthy women, with cutoff levels of 3.72 mg/L and 5.15mg/dL, respectively, as determined using receiver operating characteristic (ROC) curve analysis. HsCRP was also able to differentiate severe preeclampsia from non-severe preeclampsia at a cutoff level ≥8.75 mg/L (high Youden index >0.6). However, uric acid levels failed to discriminate between pregnant women with severe and non-severe preeclampsia. Elevated hsCRP levels were strongly associated with low birth weight of newborns in pregnant women with preeclampsia and healthy control groups (P=0.001) and with disease severity (P<0.001), respectively. Conclusions HsCRP can be used as an important diagnostic tool to exclude and evaluate the severity of preeclampsia.
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Affiliation(s)
- Jhuma Biswas
- Department of Obstetrics and Gynaecology, Jhargram Government
Medical College and Hospital, India
| | - Mousumi Datta
- Department of Community Medicine, R. G. Kar Medical College
and Hospital, India
| | - Kaushik Kar
- Department of Biochemistry, Rampurhat Medical College and
Hospital, India
| | - Divyangana Mitra
- Department of Obstetrics and Gynaecology, Institute of
Post-Graduate Medical Education and Research (IPGMER), India
| | - Lakavath Jyothi
- Department of Obstetrics and Gynaecology, Sarat Chandra
Chattopadhyay Government Medical College and Hospital, India
| | - Arghya Maitra
- Department of Obstetrics and Gynaecology, Calcutta National
Medical College and Hospital, India
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Guenoun D, Quemeneur MS, Ayobi A, Castineira C, Quenet S, Kiewsky J, Mahfoud M, Avare C, Chaibi Y, Champsaur P. Automated vertebral compression fracture detection and quantification on opportunistic CT scans: a performance evaluation. Clin Radiol 2025; 83:106831. [PMID: 40010260 DOI: 10.1016/j.crad.2025.106831] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2024] [Revised: 01/14/2025] [Accepted: 01/21/2025] [Indexed: 02/28/2025]
Abstract
AIM Since the majority of vertebral compression fractures (VCFs) are asymptomatic, they often go undetected on opportunistic CT scans. To reduce rates of undiagnosed osteoporosis, we developed a deep learning (DL)-based algorithm using 2D/3D U-Nets convolutional neural networks to opportunistically screen for VCF on CT scans. This study aimed to evaluate the performance of the algorithm using external real-world data. MATERIALS AND METHODS CT scans acquired for various indications other than a suspicion of VCF from January 2019 to August 2020 were retrospectively and consecutively collected. The algorithm was designed to label each vertebra, detect VCF, measure vertebral height loss (VHL) and calculate mean Hounsfield Units (mean HU) for vertebral bone attenuation. For the ground truth, two board-certified radiologists defined if VCF was present and performed the measurements. The algorithm analyzed the scans and the results were compared to the experts' assessments. RESULTS A total of 100 patients (mean age: 76.6 years ± 10.1[SD], 72% women) were evaluated. The overall labeling agreement was 94.9% (95%CI: 93.7%-95.9%). Regarding VHL, the 95% limits of agreement (LoA) between the algorithm and the radiologists was [-9.3, 8.6]; 94.1% of the differences lay within the radiologists' LoA and the intraclass correlation coefficient was 0.854 (95%CI: 0.822-0.881). For the mean HU, Pearson's correlation was 0.89 (95%CI: 0.84-0.92; p-value <0.0001). Finally, the algorithm's VCF screening sensitivity and specificity were 92.3% (95%CI: 81.5%-97.9%) and 91.7% (95%CI: 80.0%-97.7%), respectively. CONCLUSIONS This automated tool for screening and quantification of opportunistic VCF demonstrated high reliability and performance that may facilitate radiologists' task and improve opportunistic osteoporosis assessments.
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Affiliation(s)
- D Guenoun
- Department of Radiology, Institute for Locomotion, Sainte-Marguerite Hospital, APHM, 13009 Marseille, France; Institute of Movement Sciences (ISM), CNRS, Aix Marseille University, 13005 Marseille, France
| | - M S Quemeneur
- Department of Radiology, Institute for Locomotion, Sainte-Marguerite Hospital, APHM, 13009 Marseille, France
| | - A Ayobi
- Avicenna.AI, 375 Avenue Du Mistral, 13600 La Ciotat, France.
| | - C Castineira
- Avicenna.AI, 375 Avenue Du Mistral, 13600 La Ciotat, France
| | - S Quenet
- Avicenna.AI, 375 Avenue Du Mistral, 13600 La Ciotat, France
| | - J Kiewsky
- Avicenna.AI, 375 Avenue Du Mistral, 13600 La Ciotat, France
| | - M Mahfoud
- Avicenna.AI, 375 Avenue Du Mistral, 13600 La Ciotat, France
| | - C Avare
- Avicenna.AI, 375 Avenue Du Mistral, 13600 La Ciotat, France
| | - Y Chaibi
- Avicenna.AI, 375 Avenue Du Mistral, 13600 La Ciotat, France
| | - P Champsaur
- Department of Radiology, Institute for Locomotion, Sainte-Marguerite Hospital, APHM, 13009 Marseille, France
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Nair SS, Varghese RE, Saji A, Thekkuveettil A. Validation study of a novel, rapid, open platform real-time LAMP assay for early diagnosis of pulmonary tuberculosis. Sci Rep 2025; 15:10069. [PMID: 40128264 PMCID: PMC11933381 DOI: 10.1038/s41598-025-93565-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2024] [Accepted: 03/07/2025] [Indexed: 03/26/2025] Open
Abstract
Current nucleic acid amplification techniques for the diagnosis of pulmonary tuberculosis (TB) lack the simplicity and affordability of achieving the goals envisioned in the WHO END-TB strategy, particularly for low- and middle-income countries (LMICs). Here we report a cost-effective real-time LAMP (rt-LAMP) assay with high sensitivity for the early diagnosis of pulmonary TB. A sample size of 350 was calculated using Buderer's formula. The assay was validated in the laboratory using mpt64 cloned gene targets and clinical patient samples. The lower limit of detection for the rt-LAMP assay was observed as 10 copies/µl. Out of 350 suspected TB patient samples, 47 were positive for MGIT culture (microbiological reference standard, MRS), 42 were positive for Xpert MTB/RIF and 41 were positive for rt-LAMP assay. Compared to MRS, rt-LAMP showed a sensitivity of 89.36% (95% CI 76.9-96.45%) and a specificity of 94.06% (95% CI 90.77-96.44%). When compared to Xpert MTB/RIF, rt-LAMP showed a sensitivity of 93.33% (95% CI 83.80-98.15%), a specificity of 98.62% (95% CI 96.51-99.62%), negative predictive value of 98.62% (95% CI 96.52-99.47%), positive predictive value of 93.33% (95% CI 84.07-97.38%). Youden index value of rt-LAMP was 0.92 when compared with Xpert MTB/RIF, indicating a significantly low false positive rate. As the technology has been developed in an open platform, the assay will be useful in early diagnosis of pulmonary TB, particularly in screening large susceptible populations in LMICs.
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Affiliation(s)
- Swathy S Nair
- Division of Molecular Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, 695012, India
| | - Ria Elza Varghese
- Division of Molecular Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, 695012, India
| | - Anjana Saji
- Division of Molecular Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, 695012, India
| | - Anoopkumar Thekkuveettil
- Division of Molecular Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, 695012, India.
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Ngalame AL, Watching D, Kibu OZ, Zeukóo EM, Nsagha DS. Assessment of the diagnostic performance of the SD Bioline Malaria antigen test for the diagnosis of malaria in the Tombel health district, Southwest region of Cameroon. PLoS One 2025; 20:e0298992. [PMID: 40080493 PMCID: PMC11906078 DOI: 10.1371/journal.pone.0298992] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2024] [Accepted: 10/31/2024] [Indexed: 03/15/2025] Open
Abstract
Malaria rapid diagnostic tests (mRDTs) are commonly used for the diagnosis of malaria in resource-limited settings. However, the sensitivity of RDTs may vary depending on the brand. The aim of this study was to assess the diagnostic performance the SD Bioline Malaria Plasmodium falciparum antigen rapid diagnostic test (Ag P.f RDT) for the diagnosis of malaria in the Tombel Health District (THD). This was a cross-sectional community-based study targeting persons living within the THD from 30th April to 20th June 2023. A consecutive sampling technique was used to collect blood samples among 250 symptomatic and asymptomatic individuals and tested using the SD Bioline Malaria Ag P.f RDT and microscopy. Data was analysed using SPSS version 25.0. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated to assess the diagnostic accuracy of the RDT. Microscopy identified 133 (53.2%) symptomatic and asymptomatic participants with malaria and the mRDT identified 60 (24%) cases with 52 (20.8%) low parasites density and 8 (3.2%) moderate parasites density. The sensitivity of Malaria Ag P.f RDT was 45.0%, the test correctly identified 60 (45%) of true positive P. falciparium cases. The specificity of 100% showed that the test correctly identified all negative cases. PPV was 100%, there is a very high likelihood that all the positive cases are truly infected. The lower NPV of 61.5%, there is still a chance the negative cases might be infected. The Area Under the Curver (AUC) = 0.78 with moderate diagnostic suggesting that there is 22% chance that the test can produce a false positive result. The overall accuracy of mRDT in the THA is moderate. This level of accuracy may be acceptable in some contexts, but it is not ideal for a screening test, particularly for a disease like malaria that can have serious health consequences if left untreated.
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Affiliation(s)
- Abigail L. Ngalame
- Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, Buea, Cameroon
| | - Djakissam Watching
- Department of Medical Laboratory Sciences, Faculty of Health Sciences, University of Buea, Buea, Cameroon
| | - Odette Z. Kibu
- Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, Buea, Cameroon
| | - Elisabeth M. Zeukóo
- Department of Biomedical Sciences, Faculty of Health Sciences, University of Buea, Buea, Cameroon
| | - Dickson S. Nsagha
- Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, Buea, Cameroon
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8
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Ambrogio S, Verdon I, Laureano B, Ramnarine KV, Fedele F, Vilic D, Honey I, Barton E, Goncalves C, Mak SM, Shuaib H, Jacques A. Independent Evaluation of a Commercial AI Software for Incidental Findings of Pulmonary Embolism (IPE) on a Large Hospital Retrospective Dataset. Radiol Res Pract 2025; 2025:9091895. [PMID: 40226816 PMCID: PMC11991795 DOI: 10.1155/rrp/9091895] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2024] [Accepted: 02/22/2025] [Indexed: 04/15/2025] Open
Abstract
Background: Early treatment of pulmonary embolism is associated with better outcomes, yet incidental PE (IPE) is frequently missed. This retrospective study aims to provide an independent assessment an artificial intelligence (AI) software, developed for flagging IPEs on CT scans. Methods: The study included consecutive CT examinations of 5042 unique patients (8 scanners and 3 protocols) acquired at a large NHS Trust between 01 January 2022 and 30 September 2022. Two radiologists blindly and independently reviewed the AI "positive" and a random selection of "negative" cases to establish the reference standard (n = 200). Discrepancies were adjudicated by a third radiologist. The clinical reports of the 200 cases were reviewed for comparison. Performance metrics for the software were calculated for the full (n = 5042) and reviewed (n = 200) cohorts separately. Results: Based on the reference standard, the IPE prevalence was 1.6% (81/5041). Across the reviewed cohort, the algorithm detected PE with a sensitivity of 96.4%, a specificity of 89.7%, a PPV of 87.1%, an NPV of 97.2%, and an accuracy of 92.5%. Across the full cohort, the algorithm exhibited a sensitivity of 96.4%, a specificity of 99.8%, a PPV of 87.1%, an NPV of 99.9%, and an accuracy of 99.7%. A review of the original clinical reports indicated that 11 cases of IPE were initially unreported. A total of 34 examinations were rejected by the software. While the scanner performed consistently across patient sexes and ethnicities, discrepancies were found among CT scanners. Conclusions: The AI software detected IPE with a high diagnostic accuracy on a large NHS dataset, showing that AI-supported reporting could improve diagnostic accuracy and reduce times to diagnosis.
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Affiliation(s)
- S. Ambrogio
- Department of Medical Physics and Clinical Engineering, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - I. Verdon
- Department of Medical Physics and Clinical Engineering, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - B. Laureano
- Department of Medical Physics and Clinical Engineering, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - K. V. Ramnarine
- Department of Medical Physics and Clinical Engineering, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - F. Fedele
- Department of Medical Physics and Clinical Engineering, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - D. Vilic
- Department of Medical Physics and Clinical Engineering, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - I. Honey
- Department of Medical Physics and Clinical Engineering, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - E. Barton
- Department of Medical Physics and Clinical Engineering, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - C. Goncalves
- Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - Sze Mun Mak
- Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - H. Shuaib
- Department of Medical Physics and Clinical Engineering, Guy's and St Thomas' NHS Foundation Trust, London, UK
| | - A. Jacques
- Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, UK
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9
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Wongphutorn P, Worasith C, Kopolrat KY, Eamudomkarn C, Pitaksakulrat O, Hongsrichan N, Tippayawat P, Techasen A, Sithithaworn J, Homsombut T, Odermatt P, Noordin R, Sithithaworn P. Partially purified Strongyloides ratti antigen improved the diagnostic performance of strongyloidiasis by enzyme-linked immunosorbent assay (ELISA) and immunochromatographic test (ICT). Microbiol Spectr 2025; 13:e0236824. [PMID: 39902967 DOI: 10.1128/spectrum.02368-24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2024] [Accepted: 01/06/2025] [Indexed: 02/06/2025] Open
Abstract
Strongyloides stercoralis infection is a neglected tropical disease with a global distribution. Serodiagnosis is a sensitive method, but improving its performance and simplifying into a point-of-care test (POCT) are needed. This study aimed to improve the diagnostic performance of serological tests using partially purified Strongyloides ratti antigen in an enzyme-linked immunosorbent assay (ELISA) and an immunochromatographic test (ICT). Crude S. ratti antigen was purified by an IgG affinity column to partition the antigen into flow-through, washing fraction (WF), and elution fractions. Optimized ELISA and ICT using crude and antigen fractions were used to analyze sera from three groups of subjects. Group 1 comprised subjects with proven strongyloidiasis, Group 2 were subjects with other parasitic infections, and Group 3 were negative parasitic infections. The diagnostic performance and Kappa agreement of the serological tests were analyzed and compared, using larvae detection as the reference test (fecal examination). The results showed that the WF was the most efficient antigen in terms of sensitivity and specificity, as determined by the ELISA and ICT. Kappa's agreement between fecal examination and WF-ELISA was moderate (Kappa = 0.52), and WF-ICT was almost perfect (Kappa = 0.94). The WF antigen reduced cross-reactivity to other parasitic infections, that is, Opisthorchis viverrini, Taenia spp., and hookworms, compared to crude S. ratti antigen when assessed by ELISA and ICT. We concluded that the WF of purified S. ratti improved the ELISA and ICT diagnostic performance, and the latter assay format could be used as a POCT for screening and controlling strongyloidiasis.IMPORTANCEThis study aimed to improve the serological diagnosis of strongyloidiasis, a disease caused by infection with the intestinal nematode Strongyloides stercoralis, by evaluating the impact of Strongyloides ratti antigen purification using an IgG affinity column for detecting parasite-specific IgG in serum via enzyme-linked immunosorbent assay (ELISA) and immunochromatographic test (ICT) formats. Compared to crude S. ratti antigen, the washing fraction (WF) of the purified antigen demonstrated significantly improved sensitivity and specificity in both ELISA and ICT, achieving strong diagnostic concordance with the gold-standard fecal examination. Furthermore, the WF antigen fraction exhibited reduced cross-reactivity with coinfections caused by the liver fluke (Opisthorchis viverrini), tapeworms (Taenia spp.), and hookworms. These findings underscore antigen purification as a promising strategy to enhance the accuracy of strongyloidiasis serodiagnosis.
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Affiliation(s)
- Phattharaphon Wongphutorn
- Biomedical Science Program, Graduate School, Khon Kaen University, Khon Kaen, Thailand
- Cholangiocarcinoma Research Institute, Khon Kaen University, Khon Kaen, Thailand
| | - Chanika Worasith
- Department of Adult Nursing, Faculty of Nursing, Khon Kaen University, Khon Kaen, Thailand
| | - Kulthida Y Kopolrat
- Faculty of Public Health, Kasetsart University Chalermphrakiat Sakon Nakhon Province Campus, Sakhon Nakhon, Thailand
| | - Chatanun Eamudomkarn
- Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
| | - Opal Pitaksakulrat
- Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
| | - Nuttanan Hongsrichan
- Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
| | | | - Anchalee Techasen
- Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand
| | | | | | - Peter Odermatt
- Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Allschwil, University of Basel, Basel, Switzerland
| | - Rahmah Noordin
- Department of Parasitology and Medical Entomology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Paiboon Sithithaworn
- Cholangiocarcinoma Research Institute, Khon Kaen University, Khon Kaen, Thailand
- Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
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10
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Albashir SM, Robert RC, Jairath NN, Raub CB, Alzumai OA, Salem SS. The rapid shallow breathing index (RSBI) as a predictor for extubation success in medical and surgical ICU patients: A retrospective cohort study. Heart Lung 2025; 70:321-328. [PMID: 39848164 DOI: 10.1016/j.hrtlng.2025.01.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/19/2024] [Revised: 01/01/2025] [Accepted: 01/12/2025] [Indexed: 01/25/2025]
Abstract
BACKGROUND Endotracheal intubation and mechanical ventilation comprise common life support interventions for patients in intensive care units (ICUs). Premature or delayed extubation increases the risk of morbidity and mortality. Despite following weaning protocols, 10-20 % of patients fail extubation within 48 h. To improve extubation success, predictors such as the rapid shallow breathing index (RSBI-the ratio of respiratory rate to tidal volume) are needed. The current RSBI value (<105 breaths/min/L) comes from clinically outdated methods and small samples. OBJECTIVE To identify the highest-performing RSBI threshold value associated with extubation success using current weaning protocols in a large sample of medical and surgical ICU patients. METHODS Using secondary data from hospital records, receiver operating characteristic (ROC) analysis of the RSBI, measured immediately after a spontaneous breathing trial, was conducted for 1313 mechanically ventilated (≥ 48 h and ≤ 21 days) patients at one hospital in Saudi Arabia. RESULTS The sample of 61.5 % medical and 38.5 % surgical patients included 65 % males with a mean age of 53 years and an extubation failure rate of 12 %. Ideal RSBI threshold values differed by medical and surgical samples. For each sample, the area under the ROC curve approximated 0.5 for the RSBI, and multivariable logistic regression identified a unique set of physiologic parameters to predict successful extubation. CONCLUSION The RSBI alone demonstrated low diagnostic performance for predicting successful extubation using current weaning protocols. However, results suggest needed updates for RSBI threshold values in current weaning protocols to optimize RSBI use with other predictors for extubation success.
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Affiliation(s)
- Shaykhah M Albashir
- College of Nursing, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, Riyadh, Saudi Arabia; Ministry of the National Guard Health Affairs Riyadh, Saudi Arabia; The Catholic University of America, USA; Conway School of Nursing, USA.
| | - Rebecca C Robert
- The Catholic University of America, USA; Conway School of Nursing, USA
| | - Nalini N Jairath
- The Catholic University of America, USA; Conway School of Nursing, USA
| | - Christopher B Raub
- The Catholic University of America, USA; Department of Biomedical Engineering, USA
| | - Omar A Alzumai
- King Abdullah International Medical Research Center, Riyadh, Saudi Arabia; Ministry of the National Guard Health Affairs Riyadh, Saudi Arabia
| | - Samah Saad Salem
- College of Nursing, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, Riyadh, Saudi Arabia; Ministry of the National Guard Health Affairs Riyadh, Saudi Arabia; Medical-Surgical Nursing Department, Faculty of Nursing, Cairo University, Cairo, Egypt
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11
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Falci DR, Pasqualotto AC, Vieceli T, Sued O, Reis N, Soares RBA, Godoy CSM, Hatem NA, Dos Santos NP, Regis Razzolini B, Sprinz E, Perez F. Performance of urine Xpert MTB/RIF ultra in a tuberculosis screening strategy in hospitalized patients with advanced HIV disease: Results from an implementation initiative in Brazil. HIV Med 2025; 26:427-433. [PMID: 39657975 DOI: 10.1111/hiv.13746] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2024] [Accepted: 11/14/2024] [Indexed: 12/12/2024]
Abstract
OBJECTIVES To evaluate the performance of Xpert MTB/RIF Ultra testing in urine samples as part of a TB screening strategy in patients with advanced HIV disease (AHD). METHODS We conducted a multicentre prospective cohort study across three HIV reference hospitals in Brazil, between January and December 2023. The study included adult hospitalized patients with AHD, defined by a CD4 count of <200 cells/μL in the last 3 months or clinical presentation suggestive of opportunistic infection, without effective antiretroviral treatment. Participants underwent systematic tuberculosis (TB) screening using urine Xpert MTB/RIF Ultra and TB lipoarabinomannan (TB-LAM) tests. The diagnosis performance of urine Xpert MTB/RIF Ultra was assessed including sensitivity, specificity, and positive and negative predictive values. Disease characterization was based on the Global Tuberculosis Dictionary. Survival at 30 and 90 days was also evaluated. RESULTS Urine molecular testing was performed on 133 patients. Xpert MTB/RIF Ultra showed a sensitivity of 20.7% in bacteriologically confirmed TB cases and 21.2% in cases that included both clinically diagnosed and bacteriologically confirmed TB. The addition of urine Xpert MTB/RIF Ultra to TB-LAM led to the detection of three additional cases, representing a 6.3% increase from the 48 cases detected by TB-LAM. Xpert MTB/RIF Ultra had a specificity of 96.9% and no rifampicine resistance mutations were detected. Overall mortality was 16/133 (12.0%) at 30 days and 25/127 (19.7%) at 90 days. CONCLUSIONS There was a high overlap between urine TB-LAM and Xpert MTB/RIF Ultra results, with the addition of Xpert MTB/RIF providing limited additional benefit for TB screening in patients with AHD.
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Affiliation(s)
- Diego R Falci
- Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
| | - Alessandro C Pasqualotto
- Santa Casa de Porto Alegre, Porto Alegre, Brazil
- Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil
| | - Tarsila Vieceli
- Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil
| | - Omar Sued
- Pan American Health Organization, Washington, District of Columbia, USA
| | - Nicole Reis
- Associacao Hospitalar Vila Nova, Porto Alegre, Brazil
| | - Renata B A Soares
- Hospital Estadual de Doenças Tropicais Dr. Anuar Auad, Goiania, Brazil
- Pontificia Universidade Catolica de Goias, Goiania, Brazil
| | - Cassia S M Godoy
- Hospital Estadual de Doenças Tropicais Dr. Anuar Auad, Goiania, Brazil
- Pontificia Universidade Catolica de Goias, Goiania, Brazil
| | - Nayla A Hatem
- Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil
| | | | | | - Eduardo Sprinz
- Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
| | - Freddy Perez
- Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil
- Pan American Health Organization, Washington, District of Columbia, USA
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12
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Vatsaraj I, Mohsen Y, Grüne L, Steffens L, Loeffler S, Horlitz M, Stöckigt F, Trayanova N. 12 lead surface ECGs as a surrogate of atrial electrical remodeling - a deep learning based approach. J Electrocardiol 2025; 89:153862. [PMID: 39742814 PMCID: PMC11929969 DOI: 10.1016/j.jelectrocard.2024.153862] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2024] [Revised: 11/02/2024] [Accepted: 12/13/2024] [Indexed: 01/04/2025]
Abstract
BACKGROUND AND PURPOSE Atrial fibrillation (AF), a common arrhythmia, is linked with atrial electrical and structural changes, notably low voltage areas (LVAs) which are associated with poor ablation outcomes and increased thromboembolic risk. This study aims to evaluate the efficacy of a deep learning model applied to 12‑lead ECGs for non-invasively predicting the presence of LVAs, potentially guiding pre-ablation strategies and improving patient outcomes. METHODS A retrospective analysis was conducted on 204 AF patients, who underwent catheter ablation. Pre-procedural sinus rhythm ECGs and electroanatomical maps (EAM) were utilized alongside demographic data to train a deep learning model combining Long Short-Term Memory networks and Convolutional Neural Networks with a cross-attention layer. Model performance was evaluated using a 5-fold cross-validation strategy. RESULTS The model effectively identified the presence of LVA on the examined atrial walls, achieving accuracies of 78 % for both the anterior and posterior walls, and 82 % for the LA roof. Moreover, it accurately predicted the global left atrial (LA) average voltage <0.7 mV, with an accuracy of 88 %. CONCLUSION The study showcases the potential of deep learning applied to 12‑lead ECGs to effectively predict regional LVAs and global LA voltage in AF patients non-invasively. This model offers a promising tool for the pre-ablation assessment of atrial substrate, facilitating personalized therapeutic strategies and potentially enhancing ablation success rates.
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Affiliation(s)
- Ishan Vatsaraj
- Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD, USA; Alliance for Cardiovascular Diagnostic and Treatment Innovation, Johns Hopkins University, Baltimore, MD, USA.
| | - Yazan Mohsen
- Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD, USA; Alliance for Cardiovascular Diagnostic and Treatment Innovation, Johns Hopkins University, Baltimore, MD, USA; Department of Cardiology, Faculty of Health, School of Medicine, University Witten/Herdecke, Witten, Germany; Krankenhaus Porz am Rhein, Department of Cardiology, Electrophysiology and Rhythmology, Cologne, Germany
| | - Lukas Grüne
- Krankenhaus Porz am Rhein, Department of Cardiology, Electrophysiology and Rhythmology, Cologne, Germany
| | - Lucas Steffens
- Krankenhaus Porz am Rhein, Department of Cardiology, Electrophysiology and Rhythmology, Cologne, Germany
| | - Shane Loeffler
- Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD, USA; Alliance for Cardiovascular Diagnostic and Treatment Innovation, Johns Hopkins University, Baltimore, MD, USA
| | - Marc Horlitz
- Department of Cardiology, Faculty of Health, School of Medicine, University Witten/Herdecke, Witten, Germany; Krankenhaus Porz am Rhein, Department of Cardiology, Electrophysiology and Rhythmology, Cologne, Germany
| | - Florian Stöckigt
- Krankenhaus Porz am Rhein, Department of Cardiology, Electrophysiology and Rhythmology, Cologne, Germany; Department of Cardiology, University Hospital Bonn, Bonn, Germany
| | - Natalia Trayanova
- Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD, USA; Alliance for Cardiovascular Diagnostic and Treatment Innovation, Johns Hopkins University, Baltimore, MD, USA
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13
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Cobo T, Burgos-Artizzu XP, Ferrero S, Balcells J, Bosch J, Gené A, Murillo C, Rueda C, Boada D, Sánchez-Antón MT, Kacerovsky M, Jacobsson B, Palacio M. External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes. J Perinat Med 2025; 53:170-178. [PMID: 39575693 DOI: 10.1515/jpm-2024-0178] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/17/2024] [Accepted: 10/20/2024] [Indexed: 12/30/2024]
Abstract
OBJECTIVES To prospectively validate the diagnostic performance of a non-invasive point-of-care tool (Rapid IAI System), including vaginal alpha-fetoprotein and interleukin-6, to predict the occurrence of intra-amniotic inflammation in a Spanish cohort of patients admitted with a diagnosis of preterm labor and intact membranes. METHODS From 2017 to 2022, we prospectively evaluated a cohort of pregnant women diagnosed with preterm labor and intact membranes admitted below 34+0 weeks who underwent amniocentesis to rule-in/out intra-amniotic infection and/or inflammation. Vaginal sampling was performed at the time of amniocentesis or within 24-48 h. Amniotic fluid IL-6, vaginal alpha-fetoprotein and vaginal IL-6 concentrations were measured using a point-of-care tool provided by Hologic Inc., "Rapid IAI System". We defined intra-amniotic inflammation when amniotic fluid IL-6 values were greater than 11.3 ng/mL. During recruitment, clinicians were blinded to the results of the point-of-care tool. The original prediction model proposed by Hologic Inc. to predict intra-amniotic inflammation was validated in this cohort of patients. RESULTS We included 151 patients diagnosed with preterm labor and intact membranes. Among these, 29 (19.2 %) had intra-amniotic inflammation. The algorithm including vaginal IL-6 and alpha-fetoprotein showed an area under curve to predict intra-amniotic inflammation of 80.3 % (±5.3 %) with a sensitivity of 72.4 %, specificity of 84.6 %, positive predictive valuve (PPV) of 52.5 %, negative predictive value (NPV) of 92.9 %, and a positive likelihood ratio (LR+) of 4.6 and negative likelihood ratio (LR-) of 0.33. CONCLUSIONS External validation of a non-invasive rapid point-of-care tool, including vaginal alpha-fetoprotein and IL-6, showed very good diagnostic performance for predicting the absence of intra-amniotic inflammation in women with preterm labor and intact membranes.
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Affiliation(s)
- Teresa Cobo
- BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clinic and Hospital Sant Joan de Déu), Institut Clínic de Ginecología, Obstetrícia I Neonatología, Fetal i+D Fetal Medicine Research Center, Barcelona, Spain
- Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Departament de Cirurgia i Especialitats Medicoquirúrgiques, Universitat de Barcelona, Barcelona, Spain
- Center for Biomedical Research on Rare Diseases (CIBER-ER), Institute of Health Carlos III (ISCIII), 28029 Madrid, Spain
| | | | - Silvia Ferrero
- BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clinic and Hospital Sant Joan de Déu), Institut Clínic de Ginecología, Obstetrícia I Neonatología, Fetal i+D Fetal Medicine Research Center, Barcelona, Spain
| | - Judith Balcells
- BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clinic and Hospital Sant Joan de Déu), Institut Clínic de Ginecología, Obstetrícia I Neonatología, Fetal i+D Fetal Medicine Research Center, Barcelona, Spain
| | - Jordi Bosch
- Microbiology department, Center of Biomedical diagnostic, Hospital Clinic, ISGlobal, Barcelona, Spain
| | - Amadeu Gené
- Microbiology department, Hospital Sant Joan de Déu, Barcelona, Spain
| | - Clara Murillo
- BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clinic and Hospital Sant Joan de Déu), Institut Clínic de Ginecología, Obstetrícia I Neonatología, Fetal i+D Fetal Medicine Research Center, Barcelona, Spain
| | - Claudia Rueda
- BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clinic and Hospital Sant Joan de Déu), Institut Clínic de Ginecología, Obstetrícia I Neonatología, Fetal i+D Fetal Medicine Research Center, Barcelona, Spain
| | - David Boada
- BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clinic and Hospital Sant Joan de Déu), Institut Clínic de Ginecología, Obstetrícia I Neonatología, Fetal i+D Fetal Medicine Research Center, Barcelona, Spain
| | - Maria Teresa Sánchez-Antón
- BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clinic and Hospital Sant Joan de Déu), Institut Clínic de Ginecología, Obstetrícia I Neonatología, Fetal i+D Fetal Medicine Research Center, Barcelona, Spain
| | - Marian Kacerovsky
- Biomedical Research Center, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic
- Department of Obstetrics and Gynecology, Hospital Most, Most, Czech Republic
| | - Bo Jacobsson
- Department of Obstetrics and Gynecology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Genetics and Bioinformatics, Area of Health Data and Digitalisation, Norwegian Institute of Public Health, Oslo, Norway
| | - Montse Palacio
- BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clinic and Hospital Sant Joan de Déu), Institut Clínic de Ginecología, Obstetrícia I Neonatología, Fetal i+D Fetal Medicine Research Center, Barcelona, Spain
- Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
- Center for Biomedical Research on Rare Diseases (CIBER-ER), Institute of Health Carlos III (ISCIII), Madrid, Spain
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14
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Bernecker L, Johnsen LH, Vangberg TR. Intracranial stenosis prediction using a small set of risk factors in the Tromsø Study. BMC Med Inform Decis Mak 2025; 25:95. [PMID: 39979931 PMCID: PMC11843764 DOI: 10.1186/s12911-025-02896-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/11/2024] [Accepted: 01/28/2025] [Indexed: 02/22/2025] Open
Abstract
Intracranial atherosclerotic stenosis (ICAS) refers to a narrowing of intracranial arteries due to plaque buildup on the inside of the vessel walls restricting blood flow. Early detection of ICAS is crucial to prevent serious consequences such as stroke. Here we apply three different machine learning methods, such as support vector machines, multi-layer perceptrons and Kolmogorov-Arnold Networks to predict ICAS according to sparse risk factors from blood lipids and demographic data, including smoking habits, age, sex, diabetes, blood pressure lowering and cholesterol-lowering drugs and high-density lipoprotein. We achieved similar performance on classification compared to modern detection algorithms for ICAS in TOF-MRA (time-of-flight magnetic resonance angiography). The prevalence of ICAS in the population is relatively low, which is often case in medicine. While in the medical research community, the issue of low prevalence is established, machine learning-based research in medicine often does not take into account a critical viewpoint of the prevalence in clinical settings of their methods. We showed that with a balanced training/test set an accuracy up to 81% was achievable, while with the inclusion of prevalence, the positive predictive value was at 19% to the prevalence data, changes the performance metrics. Therefore, we highlighted the discrepancy that can arise between the results reported by the models and their clinical relevance. Furthermore, the results demonstrate the predictive potential of limited risk factors, highlighting its potential contribution to a multi-modular classification algorithm based on MRAs.
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Affiliation(s)
- Luca Bernecker
- Department of Clinical Medicine, UiT-The Arctic University of Norway, Tromsø, Norway
- PET Imaging Center, University Hospital of North Norway, Tromsø, Norway
| | - Liv-Hege Johnsen
- Department of Radiology, University Hospital of North Norway, Tromsø, Norway
| | - Torgil Riise Vangberg
- Department of Clinical Medicine, UiT-The Arctic University of Norway, Tromsø, Norway.
- PET Imaging Center, University Hospital of North Norway, Tromsø, Norway.
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15
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Namugga JV, Musubika C, Niwagaba S, Mayito J, Sande OJ. Accuracy of anti-mycobacterial protein 51 antibodies as a biomarker for latent TB infection in asymptomatic HIV positive individuals: a cross-sectional diagnostic study. BMC Res Notes 2025; 18:73. [PMID: 39962598 PMCID: PMC11834177 DOI: 10.1186/s13104-025-07134-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2024] [Accepted: 01/31/2025] [Indexed: 02/20/2025] Open
Abstract
OBJECTIVE To evaluate the diagnostic accuracy of anti-Mycobacterial Protein 51 (MPT51) antibodies in latent Tuberculosis (TB) detection among asymptomatic Human Immune Virus (HIV) positive individuals using Interferon Gamma Release Assay (IGRA) (QuantiFERON-TB Gold Plus) as the gold standard and determine the factors associated with anti-MPT51 antibody positivity among asymptomatic HIV positive individuals. RESULTS Considering QuantiFERON-TB Gold Plus as the gold standard, antibody reactivity to MPT51 revealed sensitivity of 32.6% (95% CI 24.5-40.6), specificity of 56.1% (95% CI 47.6-64.6), positive predictive value of 61.7% (95% CI 53.4-70.1) and negative predictive value of 27.7% (95% CI 20-35.4). Among the factors tested, none was independently associated with an increased risk of antibody reactivity against MPT51.
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Affiliation(s)
- Josephine Victo Namugga
- Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Uganda
| | - Carol Musubika
- Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Uganda
| | - Stuart Niwagaba
- College of Natural Sciences, Makerere University, Kampala, Uganda
| | - Jonathan Mayito
- Infectious Diseases Institute (IDI), Makerere University, Kampala, Uganda
| | - Obondo James Sande
- Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Uganda.
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16
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Miranda-Mendizabal A, Vetter D, Zambrano J, Zarp J, Chavarría V, Giménez-Palomo A, Gonzalez-Campos M, Valenti M, Walczer Baldinazzo L, Siddi S, Ferrari M, Weissmann D, Henry C, Haro JM, Vedel Kessing L, Vieta E. RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study. Ann Gen Psychiatry 2025; 24:7. [PMID: 39915772 PMCID: PMC11803998 DOI: 10.1186/s12991-024-00544-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/15/2024] [Accepted: 12/31/2024] [Indexed: 02/09/2025] Open
Abstract
INTRODUCTION Misdiagnosis of bipolar disorder (BD) can lead to ineffective treatment, increased risk of manic episodes, and increased severity. Objective diagnostic tests or precise tools to diagnose BD and distinguish it from major depressive disorder (MDD) in depressed patients are lacking. AIM To assess the external diagnostic validity of a blood-based test using an RNA epigenetic signature for the differential diagnosis of BD versus MDD in patients with depression. METHODS AND ANALYSIS Multicentre cross-sectional study including an adult sample of inpatients or outpatients diagnosed with BD or MDD, currently treated for a major depressive episode. A structured diagnostic interview based on validated scales will be conducted. Sociodemographic variables, clinical history, toxic consumption, current treatment and quality of life will be assessed. Blood samples will be obtained and stored at -80 °C until RNA sequencing analysis. The EDIT-B is a blood-based test that combines RNA editing biomarkers and individual data (e.g., age, sex, and tobacco consumption). The clinical validation performance of the EDIT-B will be evaluated using the area under the curve, sensitivity, specificity, positive and negative predictive values, and likelihood ratios. ETHICS AND DISSEMINATION The principles of the Declaration of Helsinki 2013, precision psychiatry research and good clinical practice will be followed. The Research Ethics Committees of the participating centres approved the study. Participants will receive an information sheet and must sign the informed consent before the interview. Participants' data will be pseudonymized at the research sites. Any publication will use fully anonymized data. Publications with the final study results will be disseminated in international peer-reviewed journals and presented at international conferences. STUDY REGISTRATION This study has been registered on clinicaltrials.gov (NCT05603819). Registration date: 28-10-2022.
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Affiliation(s)
- Andrea Miranda-Mendizabal
- Impact and Prevention of Mental Disorders Research Group, Sant Joan de Déu Research Institut, Santa Rosa, 39-57, 08950, Esplugues de Llobregat, Spain.
- Mental Health Networking Biomedical Research Centre (CIBERSAM), Madrid, Spain.
| | - Diana Vetter
- ALCEDIAG/Sys2Diag, CNRS UMR 9005, 1682 rue de la Valsière, Parc Euromédecine, 34188, Montpellier, France.
| | | | - Jeff Zarp
- Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen, Denmark
| | - Victor Chavarría
- Impact and Prevention of Mental Disorders Research Group, Sant Joan de Déu Research Institut, Santa Rosa, 39-57, 08950, Esplugues de Llobregat, Spain
- Acute Psychiatric Unit, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain
- Research Network on Chronicity, Primary Care, and Health Promotion and Prevention (RICAPPS), Madrid, Spain
| | - Anna Giménez-Palomo
- Mental Health Networking Biomedical Research Centre (CIBERSAM), Madrid, Spain
- Bipolar and Depressive Disorders Unit, Hospital Clinic, Barcelona, Spain
- Institute of Neurosciences, University of Barcelona, Barcelona, Spain
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
| | - Meritxell Gonzalez-Campos
- Mental Health Networking Biomedical Research Centre (CIBERSAM), Madrid, Spain
- Bipolar and Depressive Disorders Unit, Hospital Clinic, Barcelona, Spain
- Institute of Neurosciences, University of Barcelona, Barcelona, Spain
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
| | - Marc Valenti
- Mental Health Networking Biomedical Research Centre (CIBERSAM), Madrid, Spain
- Bipolar and Depressive Disorders Unit, Hospital Clinic, Barcelona, Spain
- Institute of Neurosciences, University of Barcelona, Barcelona, Spain
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
| | | | - Sara Siddi
- Impact and Prevention of Mental Disorders Research Group, Sant Joan de Déu Research Institut, Santa Rosa, 39-57, 08950, Esplugues de Llobregat, Spain
- Mental Health Networking Biomedical Research Centre (CIBERSAM), Madrid, Spain
- Teaching, Research and Innovation Unit, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain
| | - Maurizio Ferrari
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), SYNLAB SDN, Naples, Italy
| | - Dinah Weissmann
- ALCEDIAG/Sys2Diag, CNRS UMR 9005, 1682 rue de la Valsière, Parc Euromédecine, 34188, Montpellier, France
| | - Chantal Henry
- GHU Psychiatrie & Neurosciences, Paris, France
- Université Paris Cité, Paris, France
| | - Josep Maria Haro
- Impact and Prevention of Mental Disorders Research Group, Sant Joan de Déu Research Institut, Santa Rosa, 39-57, 08950, Esplugues de Llobregat, Spain
- Mental Health Networking Biomedical Research Centre (CIBERSAM), Madrid, Spain
- Teaching, Research and Innovation Unit, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain
- University of Barcelona, Barcelona, Spain
| | - Lars Vedel Kessing
- Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Eduard Vieta
- Mental Health Networking Biomedical Research Centre (CIBERSAM), Madrid, Spain
- Bipolar and Depressive Disorders Unit, Hospital Clinic, Barcelona, Spain
- Institute of Neurosciences, University of Barcelona, Barcelona, Spain
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
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Hooper V, LaFond CM, Stephenson K, Wright A. Predictive Performance of the KINDER 1 Fall Risk Assessment Tool in a Regional Health System. J Emerg Nurs 2025:S0099-1767(24)00378-7. [PMID: 39891624 DOI: 10.1016/j.jen.2024.12.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/30/2024] [Revised: 12/18/2024] [Accepted: 12/18/2024] [Indexed: 02/03/2025]
Abstract
INTRODUCTION Patient fall risk assessment in the emergency department poses a unique challenge as fall risk is often associated with risk factors other than inpatient falls. While there are many inpatient fall risk assessment tools, few have been used or validated in the ED environment. Therefore, this study examined the predictive performance of the KINDER 1 Fall Risk Assessment Tool in 10 emergency departments. METHODS A retrospective cohort design was used. Data were collected from November 15, 2023, to April 30, 2024, as a part of an electronic pilot of the KINDER 1 Fall Risk Assessment tool. Inclusion criteria encompassed all adult (≥18 years) ED visits during which a KINDER 1 fall risk assessment was completed. Descriptive statistics were used to describe overall sample characteristics. Predictive performance was calculated via multiple accuracy measurements. RESULTS KINDER 1 assessments were completed on 64,811 patients, of which 40 patient falls met inclusion criteria for final analysis. The mean age of the patients who fell was 58.46 years (±18.38). Final sensitivity was 77.5%, and the specificity was 75.8%. Fall prevalence was 0.06%. DISCUSSION KINDER 1 exhibited a sufficiently high degree of sensitivity and specificity, supporting an acceptable level of predictive performance. Additional research is recommended to compare the reliability and predictive validity of KINDER 1 to the emergency Hester Davis Scale and the Memorial Emergency Department Fall Risk Assessment Tool, as well as to compare the usability of the tools for nurses in a triage setting.
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Rajani HS, Narayanappa D. Diagnostic accuracy of combined screening algorithm for early detection of congenital heart disease among term newborns in India. J Med Screen 2025:9691413241313434. [PMID: 39828971 DOI: 10.1177/09691413241313434] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/22/2025]
Abstract
OBJECTIVE To determine the validity of a screening algorithm based on combination of clinical examination and pulse oximetry, for early detection of congenital heart disease (CHD) in term newborns. CHD is the most frequent major congenital anomaly, with prevalence of 6-12 per 1000 live births. Clinical examination alone may fail to detect CHD in more than 50% of affected newborns. Recent studies have concluded that pulse oximetry has a high sensitivity and specificity as a screening tool for critical CHD. SETTING JSS Hospital, Mysuru, Karnataka, India. METHODS In this prospective observational study, all term neonates delivered at the hospital were included. The screening algorithm consisted of seven clinical parameters and pulse oximetry screening guidelines recommended by the American Academy of Paediatrics. Term newborns with the presence of any one of the above parameters in the algorithm were considered screen-positive. Echocardiography was done in all screen positives. Newborns were classified into those with and without CHD, based on echocardiography findings at birth and clinical examination and echocardiography findings at follow-up at 6 weeks. RESULTS Among 1009 term neonates included in the study, CHD was detected in 57 (5.6%) with cyanotic CHD in 12. The sensitivity and specificity of combined screening to detect CHD was 71.93% and 95.8%, respectively. The positive predictive value was 50.62% and the negative predictive value was 98.28%. CONCLUSION Screening for CHD with a simple comprehensive algorithm, integrating clinical evaluation and pulse oximetry, has moderate sensitivity and high specificity in detecting CHD in term newborns. Further work is needed to evaluate this form of screening.
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Affiliation(s)
- Hassan S Rajani
- Department of Paediatrics, JSS Medical College, JSS Academy of Higher Education and Research, Mysore, India
| | - Doddaiah Narayanappa
- Department of Paediatrics, JSS Medical College, JSS Academy of Higher Education and Research, Mysore, India
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Fuller GW, Brown J, Dunlop M, Raftery M, Falvey ÉC. The diagnostic accuracy of EyeGuide Focus testing for concussion in elite male Rugby players. PHYSICIAN SPORTSMED 2025:1-8. [PMID: 39784486 DOI: 10.1080/00913847.2025.2451606] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/01/2024] [Revised: 12/13/2024] [Accepted: 01/07/2025] [Indexed: 01/12/2025]
Abstract
INTRODUCTION Smooth pursuit eye movements may be affected by head impacts. The EyeGuide Focus system is a simple, portable, test of visual tracking. This study investigated the diagnostic accuracy of EyeGuide measurements for detection of concussion during elite Rugby matches. METHODS A prospective diagnostic case-control study was performed in the elite 2021/2022 United Rugby Championship competition. The study population comprised consecutive players identified with match-related head impact events during the World Rugby Head Injury Assessment process, randomly chosen uninjured players, and players with match-related musculoskeletal injuries. The index test was blinded EyeGuide assessment performed by independent assessors. The reference standard was concussion diagnosed by the team doctor. Distributions of EyeGuide scores were compared between concussed and non-concussed players and receiver operator characteristic curves constructed. RESULTS EyeGuide testing was performed in 262 cases, comprising 55 concussed players and 207 non concussed players (33 head impact events, 97 uninjured controls, and 79 musculoskeletal injury controls). The distributions of EyeGuide score were similar between concussed and non-concussed cases (medians 20,120 Vs 21,522, p = 0.3; difference -1,402, 95% CI -5,332-3,865). The c-index for the receiver operating characteristic curve was 0.46 (95% CI 0.36-0.55). CONCLUSIONS EyeGuide Focus scores did not appear to discriminate between concussed and non-concussed players in a cohort of elite Rugby players.
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Affiliation(s)
- Gordon Ward Fuller
- Centre for Urgent and Emergency Care Research, School of Health and Related Research, University of Sheffield, Sheffield, UK
| | - James Brown
- Carnegie Applied Rugby Research [CARR] Centre, Carnegie School of Sport, Leeds Beckett University, Leeds, UK
- Institute of Sport and Exercise Medicine [ISEM], Department of Exercise, Sport and Lifestyle Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Tow, South Africa
- Division of Physiological Sciences, Department of Human Biology, Faculty of Health Sciences, The University of Cape Town and the Sports Science Institute of South Africa, Cape Town, South Africa
| | | | - Martin Raftery
- Department of Medicine, University College Cork, Cork, Ireland
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Tungsanga S, Nantanawijit R, Kiatamornrak P, Kulvichit W, Ngoensawat U, Tachaboon S, Dinhuzen J, Chaisuriyong W, Komolpis K, Peerapornratana S, Praditpornsilpa K, Tungsanga K, Bello AK, Srisawat N. Utility of a novel point-of-care test for albuminuria in communities at high risk for chronic kidney disease in Thailand. BMJ PUBLIC HEALTH 2025; 3:e001412. [PMID: 40017920 PMCID: PMC11812891 DOI: 10.1136/bmjph-2024-001412] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/03/2024] [Accepted: 11/14/2024] [Indexed: 03/01/2025]
Abstract
Introduction Chronic kidney disease (CKD) is a major public health concern, and early detection is crucial to prevent adverse outcomes. Albuminuria is an early marker and key prognostic marker in CKD, but reliable tools for its detection are limited particularly in low resource settings. We tested the utility of a novel, affordable point-of-care test (POCT) for albuminuria among high-risk individuals for CKD. Methods This is a community-based cross-sectional study covering 17 primary subdistrict healthcare units in Ban Phaeo District, Samut Sakhon Province, Thailand. The inclusion criteria were asymptomatic adult participants diagnosed with hypertension, diabetes and/or aged over 60 years. We measured serum creatinine and quantitative urine albumin-creatinine ratio (UACR) and administered POCT urine albumin strip test (Albii, K. BioSciences, Bangkok, Thailand) and urine dipstick test for protein. Participants with albuminuria or estimated glomerular filtration rate (eGFR) by CKD-EPI 2009 equation <60 mL/min/1.73 m2 were considered to have suspected CKD. We evaluated diagnostic performance of POCT urine albumin strip. Results Among 2307 participants, 489 (20.3%) participants had reduced eGFR and/or albuminuria. The median eGFR was 93.23 (87.82, 98.73) mL/min/m2, and the median UACR was 9.15 (5.09, 20.96) mg/g. The POCT urine albumin strip showed a sensitivity of 0.70, specificity of 0.97 and accuracy of 0.92 compared with the quantitative UACR. Conversely, the POCT urine dipstick for protein had poor sensitivity, positive predictive value and accuracy. Conclusion The urine albumin test strip is a highly effective tool to conduct point-of-care identification for early CKD among high-risk populations. Given the test's diagnostic performance and ease of use, such test should be incorporated into health policy.
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Affiliation(s)
- Somkanya Tungsanga
- Medicine, Chulalongkorn University, Bangkok, Thailand
- Medicine, University of Alberta, Edmonton, Alberta, Canada
| | | | | | - Win Kulvichit
- Department of Medicine, Chulalongkorn University, Bangkok, Thailand
| | - Umphan Ngoensawat
- Thai Red Cross Society, Bangkok, Thailand
- Chulalongkorn University, Bangkok, Thailand
| | - Sasipa Tachaboon
- Thai Red Cross Society, Bangkok, Thailand
- Chulalongkorn University, Bangkok, Thailand
| | - Janejira Dinhuzen
- Thai Red Cross Society, Bangkok, Thailand
- Chulalongkorn University, Bangkok, Thailand
| | | | - Kittinan Komolpis
- Chulalongkorn University, Bangkok, Thailand
- Research Unit of Chulalongkorn University, Bangkok, Thailand
| | - Sadudee Peerapornratana
- Thai Red Cross Society, Bangkok, Thailand
- Department of Medicine, Chulalongkorn University, Bangkok, Thailand
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Vadakkeveedan AA, Poovathumparambil V, Senapathy RT, Shaji IM, Padiyath R, Jayachandran AK, Kunheenkutty RP, Savad N. Pediatric simple triage score: A simplified approach for triaging pediatric patients with fever in the emergency department. Turk J Emerg Med 2025; 25:25-31. [PMID: 39882096 PMCID: PMC11774433 DOI: 10.4103/tjem.tjem_101_24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/14/2024] [Revised: 09/05/2024] [Accepted: 09/09/2024] [Indexed: 01/31/2025] Open
Abstract
INTRODUCTION The initial 24-h period following admission to a hospital holds profound significance for pediatric patients, representing a critical window where proactive interventions can substantially influence outcomes. We devised a simple triage system, pediatric simple triage score (PSTS), to see whether rapid triage of sick pediatric patients with fever can be done using the new triage system in the emergency department (ED) to predict hospital admission. METHODS This was a prospective observational study, conducted at the department of emergency medicine of a tertiary care teaching hospital in southern India. A prospective cohort of children presenting to the ED underwent assessment for temperature, oxygen saturation (SpO2), pulse rate, respiratory rate, sensorium, and hydration status. Sensorium was evaluated based on criteria such as poor cry, poor feeding, or decreased activity, while hydration status was assessed using indicators such as decreased urine output, dry mucous membranes, or reduced skin turgor. Subsequently, participants were triaged according to the National Institute for Health and Care Excellence (NICE) guidelines. We then monitored the admission outcomes, whether they were admitted to the intensive care unit (ICU), the ward, or discharged, based on clinical decisions made by the pediatric consultant. RESULTS In this study involving 350 participants, the mean age was found to be 2.72 years (standard deviation [SD] ±1.78), with a range from 29 days to 5 years. The study population consisted of 60.86% males with a total of 213 patients. Examining vital signs, the mean heart rate was 135.07 beats/min (SD ± 21.58), with a range of 82-200 beats/min. The mean temperature was 37.57°C (SD ± 0.52), with values ranging from 36.80°C to 39.20°C. The mean respiratory rate was 36.28 breaths/min (SD ± 14.06), varying from 20 to 90 breaths/min. SpO2 averaged at 96.31% (SD ± 3.64), with values ranging between 70% and 100%. Abnormal sensorium was observed in 10.86% of the participants, while seizures were reported in 2.57%. Dehydration was present in 3.71% of the study population. Among the study participants, 24.57% were admitted to the ICU, 30.57% to the ward, and 44.86% were treated as outpatients. According to PSTS, 192 (54.86%) participants were triaged to green, 119 (34%) participants to yellow, and 39 (11.14%) participants to red. The PSTS demonstrated a sensitivity of 59.59% and a specificity of 72.61% in predicting hospital admission. The NICE triage system had a sensitivity of 80.31%, in predicting the admission (either ward/ICU), with a specificity of 72.61%. CONCLUSION The PSTS demonstrated fair agreement with the NICE; it exhibited lower sensitivity and positive predictive value. However, the simplicity of the new system renders it potentially useful, especially in resource-limited settings.
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Affiliation(s)
| | | | - Rohan Thomas Senapathy
- Department of Emergency Medicine, Travancore Medical College Hospital, Kollam, Kerala, India
| | - Ijas Muhammed Shaji
- Department of Emergency Medicine, Travancore Medical College Hospital, Kollam, Kerala, India
| | - Ridha Padiyath
- Department of Dermatology, Travancore Medical College Hospital, Kollam, Kerala, India
| | | | - Roshan P. Kunheenkutty
- Department of Emergency Medicine, Travancore Medical College Hospital, Kollam, Kerala, India
| | - Nadeer Savad
- Department of Emergency Medicine, Travancore Medical College Hospital, Kollam, Kerala, India
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Kimura H, Furuhata R, Matsuo T, Suzuki T, Matsumura N, Sato K, Iwamoto T. Point of care ultrasound combined with CTS-6 to diagnose idiopathic carpal tunnel syndrome. J Orthop Sci 2025; 30:85-90. [PMID: 38302310 DOI: 10.1016/j.jos.2024.01.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/02/2023] [Revised: 01/10/2024] [Accepted: 01/23/2024] [Indexed: 02/03/2024]
Abstract
BACKGROUND This study aimed to demonstrate the effectiveness of our new diagnostic chart using point of care ultrasound combined with CTS-6 for diagnosing idiopathic carpal tunnel syndrome. METHODS We conducted a retrospective analysis of the data of patients who visited our department and received point of care ultrasound combined with CTS-6 from 2020 to 2023. Data regarding age, sex, initial and final diagnosis, cross-sectional area of the median nerve, CTS-6 score, and electrodiagnostic severity were obtained and statistically analyzed. RESULTS Of the 177 wrists included in our study, 138 (78 %) were diagnosed with carpal tunnel syndrome, while 39 (22 %) were not (non-carpal tunnel syndrome). With our diagnostic method, 127 wrists (72 %) were diagnosed initially with carpal tunnel syndrome, 23 wrists (13 %) with non-carpal tunnel syndrome, and the rest 27 wrists (15 %) as borderline. Our initial diagnoses of carpal tunnel syndrome and non-carpal tunnel syndrome were maintained in all cases except for two. Cross-sectional area, CTS-6 score, and electrodiagnostic severity showed a positive correlation. A post hoc analysis showed that the new scoring system (CTS-6 score + 2 × cross-sectional area) with a cutoff value of 31.25 points showed a sensitivity as high as 95 % and a specificity of 100 %. CONCLUSIONS Our findings suggest that most suspected idiopathic carpal tunnel syndrome cases can be diagnosed correctly using the diagnostic chart. Although additional tools, including electrodiagnostic studies, may be needed for borderline cases, the use of point of care ultrasound combined with CTS-6 may be a recommendable first-line confirmatory test because point of care ultrasound and CTS-6 could be complementary tools, and this chart may be especially beneficial for atypical or outlier cases. LEVEL OF EVIDENCE Diagnostic III.
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Affiliation(s)
- Hiroo Kimura
- Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan; Department of Orthopaedic Surgery, Kitasato Institute Hospital, Tokyo, Japan.
| | - Ryogo Furuhata
- Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.
| | - Tomoki Matsuo
- Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.
| | - Taku Suzuki
- Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.
| | - Noboru Matsumura
- Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.
| | - Kazuki Sato
- Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan.
| | - Takuji Iwamoto
- Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.
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Alwakeel M, Obeidat M, Nanah A, Abdeljaleel F, Wang X, Fadell F. Evaluating the Diagnostic Performance of Nasal Methicillin-Resistant Staphylococcus aureus Polymerase Chain Reaction in Hospital-Acquired Pneumonia Within the Intensive Care Unit. A Retrospective Study. J Intensive Care Med 2025; 40:54-59. [PMID: 39051603 DOI: 10.1177/08850666241264774] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/27/2024]
Abstract
Background: The methicillin-resistant Staphylococcus aureus (MRSA) accounts for 20% to 40% of all hospital-acquired pneumonia (HAP) cases with mortality rates up to 55%. Prompt and accurate diagnosis is essential, especially in intensive care unit (ICU) patients. Nasal MRSA polymerase chain reaction (PCR) diagnostic utility evidence is conflicting in the literature for HAP due to a low number of HAP patients included in prior studies or due to the lack of high-yield gold standard cultures defined for comparisons. Methods: This was a retrospective cohort study conducted in a 65-bed medical ICU, and encompassing all adult patients admitted from January 2015 to March 2023 for HAP. Respiratory cultures included were those obtained by bronchoalveolar lavage or endotracheal suction within 7 days of nasal MRSA PCR testing. Results: The study included 412 patients; 56.8% were males and 65% were Whites. The mean age was 60.5 years. Most patients (82.5%) underwent MRSA-PCR before intubation, and the average time between MRSA-PCR and lower respiratory cultures was 2.15 days. The diagnostic performance of nasal MRSA PCR in diagnosing HAP in the ICU yielded a sensitivity (Sen) of 47.83%, specificity (Sp) of 92.29%, positive predictive value (PPV) of 26.83%, and negative predictive value (NPV) of 96.77%. For nonventilator HAP (nv-HAP) cases sensitivity was at 50%, specificity 92.83%, PPV 28.57%, and NPV at 97.00%. In ventilator-acquired pneumonia (VAP-HAP), the corresponding values were 42.86%, 90.91%, 23.08%, and 96.15%, respectively. Conclusion: The nasal MRSA PCR shows a high NPV and low false negative rate, suggesting it is a reliable tool for ruling out MRSA HAP in ICU patients. Care should be taken into account for disease prevalence and clinical context, as these factors may influence test performance. Further validation through prospective large-sample studies utilizing high-yield lower respiratory tract cultures is necessary to confirm our findings.
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Affiliation(s)
- Mahmoud Alwakeel
- Department of Pulmonary & Critical Care Medicine, Respiratory Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Mohammed Obeidat
- Department of Internal Medicine, Fairview Hospital-Cleveland Clinic, Cleveland, Ohio, USA
| | - Abdelrahman Nanah
- Department of Internal Medicine, Fairview Hospital-Cleveland Clinic, Cleveland, Ohio, USA
| | - Fatima Abdeljaleel
- Department of Internal Medicine, Fairview Hospital-Cleveland Clinic, Cleveland, Ohio, USA
| | - Xiaofeng Wang
- Qualitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA
| | - Francois Fadell
- Department of Medicine, Veterans Affairs Western New York Health Care System, Buffalo, New York, USA
- Jacobs School of Medicine, University at Buffalo, Buffalo, New York, USA
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Sharma A, Kaeley N, Aravindan N, Datta SS, Vasisht S. Using Lung Ultrasound Combined With N-terminal Pro-brain Natriuretic Peptide to Differentiate Acute Heart Failure From Chronic Obstructive Pulmonary Disease and Asthma in Emergency Department Patients Experiencing Acute Shortness of Breath. Cureus 2025; 17:e77171. [PMID: 39925500 PMCID: PMC11806969 DOI: 10.7759/cureus.77171] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 01/08/2025] [Indexed: 02/11/2025] Open
Abstract
INTRODUCTION Differentiating acute heart failure (AHF) from chronic obstructive pulmonary disease (COPD) or asthma is essential for prompt and appropriate treatment in patients presenting with acute shortness of breath in the emergency department (ED). AIM This study aimed to evaluate the diagnostic accuracy of bedside lung ultrasound, N-terminal pro-brain natriuretic peptide (NT-proBNP) level, and clinical criteria (using the modified Boston criteria) for differentiating AHF from COPD/asthma. MATERIALS AND METHODS This prospective cohort study was conducted in the Emergency Medicine Department of the All India Institute of Medical Sciences, Rishikesh, from June 2023 to December 2023. Patients presenting with acute shortness of breath were managed using clinical assessment (according to modified Boston criteria), lung ultrasound, and NT-proBNP measurements. RESULTS Out of 104 patients, 45 were diagnosed with AHF, and 59 had pulmonary-related causes of shortness of breath. Lung ultrasound demonstrated a sensitivity of 100%, specificity of 62.3%, negative predictive value (NPV) of 100%, and positive predictive value (PPV) of 65.15% for diagnosing heart failure. NT-proBNP, with a cutoff value of 500 pg/mL, showed 100% sensitivity, 91.8% specificity, 100% NPV, and 89.58% PPV. The Boston modified criteria had a sensitivity of 76.74%, specificity of 88.52%, NPV of 84.38%, and PPV of 82.5%. A comparison of these three diagnostic methods revealed significant differences between the ultrasound findings and both NT-proBNP and modified Boston criteria (p < 0.05). The combination of ultrasound signs and NT-proBNP yielded 100% sensitivity, specificity, NPV, and PPV. CONCLUSIONS The integration of lung ultrasound, NT-proBNP level, and clinical criteria provides a reliable and rapid approach for differentiating AHF from COPD/asthma in the ED.
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Affiliation(s)
- Ankit Sharma
- Department of Emergency Medicine, All India Institute of Medical Sciences, Rishikesh, Rishikesh, IND
| | - Nidhi Kaeley
- Department of Emergency Medicine, All India Institute of Medical Sciences, Rishikesh, Rishikesh, IND
| | - Nisarg Aravindan
- Department of Community and Family Medicine, St. John's Research Institute, Bengaluru, IND
| | - Soumya Subhra Datta
- Department of Emergency Medicine, Rajarajeswari Medical College and Hospital, Bengaluru, IND
| | - Shivani Vasisht
- Department of Dermatology, All India Institute of Medical Sciences, Rishikesh, Rishikesh, IND
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Yang S, Huang Y, Lou X, Lyu T, Wei R, Mehta HJ, Wu Y, Alvarado M, Salloum RG, Braithwaite D, Huo J, Shih YCT, Guo Y, Bian J. Toward a Computable Phenotype for Determining Eligibility of Lung Cancer Screening Using Electronic Health Records. JCO Clin Cancer Inform 2025; 9:e2400139. [PMID: 39818952 PMCID: PMC11748906 DOI: 10.1200/cci.24.00139] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2024] [Revised: 08/24/2024] [Accepted: 12/05/2024] [Indexed: 01/19/2025] Open
Abstract
PURPOSE Lung cancer screening (LCS) has the potential to reduce mortality and detect lung cancer at its early stages, but the high false-positive rate associated with low-dose computed tomography (LDCT) for LCS acts as a barrier to its widespread adoption. This study aims to develop computable phenotype (CP) algorithms on the basis of electronic health records (EHRs) to identify individual's eligibility for LCS, thereby enhancing LCS utilization in real-world settings. MATERIALS AND METHODS The study cohort included 5,778 individuals who underwent LDCT for LCS from 2012 to 2022, as recorded in the University of Florida Health Integrated Data Repository. CP rules derived from LCS guidelines were used to identify potential candidates, incorporating both structured EHR and clinical notes analyzed via natural language processing. We then conducted manual reviews of 453 randomly selected charts to refine and validate these rules, assessing CP performance using metrics, for example, F1 score, specificity, and sensitivity. RESULTS We developed an optimal CP rule that integrates both structured and unstructured data, adhering to the US Preventive Services Task Force 2013 and 2020 guidelines. This rule focuses on age (55-80 years for 2013 and 50-80 years for 2020), smoking status (current, former, and others), and pack-years (≥30 for 2013 and ≥20 for 2020), achieving F1 scores of 0.75 and 0.84 for the respective guidelines. Including unstructured data improved the F1 score performance by up to 9.2% for 2013 and 12.9% for 2020, compared with using structured data alone. CONCLUSION Our findings underscore the critical need for improved documentation of smoking information in EHRs, demonstrate the value of artificial intelligence techniques in enhancing CP performance, and confirm the effectiveness of EHR-based CP in identifying LCS-eligible individuals. This supports its potential to aid clinical decision making and optimize patient care.
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Affiliation(s)
- Shuang Yang
- Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
| | - Yu Huang
- Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
| | - Xiwei Lou
- Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
| | - Tianchen Lyu
- Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
- Cancer Informatics Shared Resource, University of Florida Health Cancer Center, Gainesville, FL
| | - Ruoqi Wei
- Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
| | - Hiren J. Mehta
- Division of Pulmonary, Critical Care, and Sleep Medicine, University of Florida College of Medicine, Gainesville, FL
| | - Yonghui Wu
- Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
- Cancer Informatics Shared Resource, University of Florida Health Cancer Center, Gainesville, FL
| | - Michelle Alvarado
- Department of Industrial and Systems Engineering, University of Florida, Gainesville, FL
| | - Ramzi G. Salloum
- Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
| | - Dejana Braithwaite
- Department of Epidemiology, College of Public Health and Health Professions, University of Florida, Gainesville, FL
- Department of Aging and Geriatric Research, College of Medicine, University of Florida, Gainesville, FL
| | - Jinhai Huo
- WW HEOR-US Markets, Bristol Myers Squibb, Lawrenceville, NJ
| | - Ya-Chen Tina Shih
- Section of Cancer Economics and Policy, Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX
| | - Yi Guo
- Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
- Cancer Informatics Shared Resource, University of Florida Health Cancer Center, Gainesville, FL
| | - Jiang Bian
- Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
- Cancer Informatics Shared Resource, University of Florida Health Cancer Center, Gainesville, FL
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Lopez-Albizu C, Cura CI, Ramirez JC, Peyran P, Benchetrit A, Danesi E, Sosa-Estani S. Congenital Chagas disease: A cohort study to assess molecular diagnostic methods at the Chagas disease national reference center of Argentina. PLoS Negl Trop Dis 2025; 19:e0012785. [PMID: 39792926 PMCID: PMC11825091 DOI: 10.1371/journal.pntd.0012785] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2024] [Revised: 02/13/2025] [Accepted: 12/16/2024] [Indexed: 01/12/2025] Open
Abstract
BACKGROUND Trypanosoma cruzi is a protozoan parasite which causes Chagas disease. Mother-to-child transmission is the main route of transmission in vector-free areas. Congenital Chagas disease refers specifically to cases arising from this route of transmission. This work evaluates the clinical sensitivity of two qPCR techniques for diagnosis of congenital Chagas disease. METHODS The study was developed in the National Institute of parasitology (NIP), Argentina, and Pan-American Health Organization/ Word Health Organization Collaborating Center for Chagas Disease. Between July 2014 and May 2018, a prospective cohort study was carried out with 499 children born to seropositive for T. cruzi infection included. The performance of qPCR techniques was compared with the gold standard diagnostic algorithm for Congenital Chagas disease (CCD-GS), which comprises performing more than one parasitological test on children from birth until nine months of age, and serology from ten months of age. FINDINGS Of the 961 babies born to women seropositive for Chagas disease who were attended at the NIP laboratory, 462 did not meet the study inclusion criteria; 22 cases were diagnosed with congenital Chagas disease. qPCR showed 100% clinical sensitivity and 98 to 100% clinical specificity for the diagnosis of congenital Chagas disease compared with CCD-GS algorithm. INTERPRETATION The results obtained in this study demonstrate the clinical accuracy and effectiveness of qPCR SatDNA and qPCR kDNA for diagnosis of congenital Chagas disease. It could be a powerful tool for chagas test and treat strategies to reduce late complications of the disease. FUNDING This work was financed by the INP Dr. Mario Fatala Chaben, ANLIS Dr. Carlos G. Malbran.
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Affiliation(s)
- Constanza Lopez-Albizu
- Instituto Nacional de Parasitología “Dr. Mario Fatala Chaben”, Administración Nacional de Laboratorios e Institutos de Salud “Dr. Carlos G. Malbran”, Buenos, Aires Argentina
| | - Carolina Inés Cura
- Instituto Nacional de Parasitología “Dr. Mario Fatala Chaben”, Administración Nacional de Laboratorios e Institutos de Salud “Dr. Carlos G. Malbran”, Buenos, Aires Argentina
| | - Juan Carlos Ramirez
- Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas (IMIPP), CONICET-GCBA, Buenos Aires, Argentina
| | - Pamela Peyran
- Instituto Nacional de Parasitología “Dr. Mario Fatala Chaben”, Administración Nacional de Laboratorios e Institutos de Salud “Dr. Carlos G. Malbran”, Buenos, Aires Argentina
| | | | - Emmaría Danesi
- Instituto Nacional de Parasitología “Dr. Mario Fatala Chaben”, Administración Nacional de Laboratorios e Institutos de Salud “Dr. Carlos G. Malbran”, Buenos, Aires Argentina
| | - Sergio Sosa-Estani
- Centro de Investigaciones Epidemiológica y Salud Pública (CIESP-IECS) CONICET
- Drugs for Neglected Diseases initiative, Rio de Janeiro, Brazil
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Charoenchue P, Khorana J, Chitapanarux T, Inmutto N, Na Chiangmai W, Amantakul A, Pojchamarnwiputh S, Tantraworasin A. Two-Dimensional Shear-Wave Elastography: Accuracy in Liver Fibrosis Staging Using Magnetic Resonance Elastography as the Reference Standard. Diagnostics (Basel) 2024; 15:62. [PMID: 39795589 PMCID: PMC11719920 DOI: 10.3390/diagnostics15010062] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2024] [Revised: 12/24/2024] [Accepted: 12/28/2024] [Indexed: 01/13/2025] Open
Abstract
Background: The accurate staging of liver fibrosis is crucial for managing chronic liver disease (CLD). Although magnetic resonance elastography (MRE) is the reference standard for noninvasive fibrosis assessment, its cost, specialized hardware, and operational demands restrict accessibility. In contrast, two-dimensional shear-wave elastography (2D-SWE) is more affordable, accessible, and widely integrated into routine ultrasound systems. Objective: Our aim was to determine the optimal 2D-SWE cut-offs for detecting significant fibrosis (≥F2) and evaluate its diagnostic performance across fibrosis stages. Methods: In this prospective study, 71 patients with suspected CLD underwent same-day MRE and 2D-SWE. MRE-defined cut-offs categorized fibrosis stages (≥3.5 kPa for significant fibrosis). Sensitivity, specificity, area under the receiver operating characteristic curve (AUROC), and likelihood ratios were calculated for various 2D-SWE thresholds. Results: At a 2D-SWE cut-off of 7.0 kPa, sensitivity for detecting ≥F2 fibrosis was 100% with a specificity of 85.7% and a positive likelihood ratio (LR+) of 7.0. Increasing the threshold to 8.0 kPa improved specificity to 91.8% while maintaining a sensitivity of 86.4% and achieving an AUROC of 0.89. For cirrhosis, a cut-off of 11.0 kPa achieved 100% sensitivity and 96.9% specificity. A 5.0 kPa cut-off reliably excluded abnormal stiffness with 89.1% sensitivity. Conclusions: Two-dimensional SWE is a reliable method for staging liver fibrosis. Thresholds of 7.0 kPa for screening significant fibrosis, 8.0 kPa for confirmation, and 11.0 kPa for diagnosing cirrhosis demonstrate high diagnostic accuracy. A 5.0 kPa cut-off effectively excludes abnormal liver stiffness.
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Affiliation(s)
- Puwitch Charoenchue
- Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand; (P.C.); (N.I.); (W.N.C.); (A.A.)
| | - Jiraporn Khorana
- Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand;
- Department of Biomedical Informatics and Clinical Epidemiology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand
- Clinical Surgical Research Center, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand
| | - Taned Chitapanarux
- Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand;
| | - Nakarin Inmutto
- Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand; (P.C.); (N.I.); (W.N.C.); (A.A.)
| | - Wittanee Na Chiangmai
- Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand; (P.C.); (N.I.); (W.N.C.); (A.A.)
| | - Amonlaya Amantakul
- Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand; (P.C.); (N.I.); (W.N.C.); (A.A.)
| | - Suwalee Pojchamarnwiputh
- Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand; (P.C.); (N.I.); (W.N.C.); (A.A.)
| | - Apichat Tantraworasin
- Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand;
- Clinical Surgical Research Center, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand
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Mickenautsch S, Yengopal V. Significance Testing for Differences Between Baseline Variables Versus the I2 Test in Detecting Selection Bias in Randomised Controlled Trials: A Simulation Study. Cureus 2024; 16:e76607. [PMID: 39886704 PMCID: PMC11779566 DOI: 10.7759/cureus.76607] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/30/2024] [Indexed: 02/01/2025] Open
Abstract
AIM The aim of the study is to test the null hypothesis that the specificities and sensitivities of the p-value-based significance test for differences between baseline variables and the I2 test for single trials do not significantly differ in detecting selection bias in randomised controlled trials (RCTs). METHODS In MS Excel (Microsoft Corp., Redmond, WA, US), 100 trials were simulated, each consisting of two treatment groups (A and B), with 100 subjects in each group. Fifty trials were biased, while 50 remained non-biased. Both tests were applied to all trials, yielding true positive, false positive, false negative, and true negative per test. Subsequently, sensitivities and specificities with a 95% confidence interval (CI) were calculated and statistically compared using the z-test. RESULTS No false positive results were observed, and subsequently, the specificities of both tests were identical (100.00%; 95% CI: 92.89%-100.00%). The sensitivity for the significance test and I2 test was 24.00% (95% CI: 13.06%-38.17%) and 76.00% (95% CI: 61.83%-86.94%), respectively. A statistical comparison of the test sensitivities yielded a significant result in favour of the I2 test (z = 5.2; p < 0.0001). Consequently, the null hypothesis for the tests' sensitivities was rejected. CONCLUSION The I2 test appears to be a more effective method than the p-value-based significance test for detecting selection bias in RCTs.
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Affiliation(s)
- Steffen Mickenautsch
- Dentistry, University of the Western Cape, Cape Town, ZAF
- Community Dentistry, University of the Witwatersrand, Johannesburg, ZAF
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Barahona G, Mc Bride B, Moran Á, Harrison R, Villatoro L, Burns R, Konings B, Bulat R, McKnight M, Treisman G, Pasricha PJ. Validation of a Hand-Held Point-of-Care Device to Measure Breath Hydrogen and Its Utility in Detecting Response to Antibiotic Treatment. Dig Dis Sci 2024; 69:4430-4436. [PMID: 39127844 PMCID: PMC11602852 DOI: 10.1007/s10620-024-08583-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/19/2024] [Accepted: 07/31/2024] [Indexed: 08/12/2024]
Abstract
BACKGROUND Breath testing for small intestinal bacterial overgrowth (SIBO) is typically performed using clinic-based equipment or single-use test kits. AIMS This study aimed to evaluate the utility of a portable, point-of-care breath analysis device (AIRE®, FoodMarble) in patients suspected to have SIBO. A technical assessment including a comparison to existing mail-in kits was first performed. Then, postprandial breath hydrogen levels of patients before and after antibiotic treatment were gathered and compared to levels seen in a healthy cohort. METHODS For the comparison, 50 patients suspected of having SIBO were provided with an AIRE device and performed concurrent LHBTs at-home with a mail-in breath test kit. For the postprandial analysis, twenty-four patients with chronic GI symptoms measured their postprandial hydrogen for 7 days prior to antibiotic treatment and for 7 days after treatment. 10 healthy controls also measured their postprandial hydrogen for 7 days. RESULTS Substantial agreement was demonstrated between AIRE and the mail-in kits for the performance of lactulose hydrogen breath tests (κ = 0.8). Prior to treatment, patients had significantly greater daily postprandial hydrogen than healthy controls (p < 0.001). The mean postprandial hydrogen of patients reduced significantly after treatment (p < 0.001). CONCLUSIONS Measuring postprandial hydrogen shows potential as a means of differentiating patients with chronic GI symptoms from healthy controls and may be useful in monitoring patients before, during, and after treatment. Future studies could help determine if pre-treatment breath gas levels are predictive of response to antibiotic treatment.
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Affiliation(s)
| | | | - Áine Moran
- FoodMarble Digestive Health, Dublin, Ireland
| | | | - Luisa Villatoro
- Johns Hopkins Center for Neurogastroenterology, Baltimore, MD, USA
| | - Robert Burns
- Johns Hopkins Center for Neurogastroenterology, Baltimore, MD, USA
| | - Bo Konings
- Johns Hopkins Center for Neurogastroenterology, Baltimore, MD, USA
| | - Robert Bulat
- Johns Hopkins Center for Neurogastroenterology, Baltimore, MD, USA
| | - Megan McKnight
- Johns Hopkins Center for Neurogastroenterology, Baltimore, MD, USA
| | - Glenn Treisman
- Department of Psychiatry and Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
| | - Pankaj J Pasricha
- Johns Hopkins Center for Neurogastroenterology, Baltimore, MD, USA.
- Department of Medicine, Mayo Clinic in Arizona, Scottsdale, AZ, USA.
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Weber SF, Wolf P, Wetzstein N, Küpper-Tetzel C, Vehreschild M, Suárez I, Rybniker J, Klingmüller A, Weber T, Güttlein M, Tobian F, Koeppel L, Beck JS, Wolf R, Manten K, Zimmermann S, Christopher DJ, Herth F, Bélard S, Denkinger CM. Diagnostic Accuracy of Lung and Abdominal Ultrasound for Tuberculosis in a German Multicenter Cohort of Patients With Presumed Tuberculosis Disease. Open Forum Infect Dis 2024; 11:ofae651. [PMID: 39691283 PMCID: PMC11651151 DOI: 10.1093/ofid/ofae651] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2024] [Indexed: 12/19/2024] Open
Abstract
Background There is limited evidence on point-of-care ultrasound for tuberculosis (TB), but studies suggest high sensitivity, especially for lung ultrasound (LUS). However, insufficient data are available on specificity of the examination and its generalizability to a broader patient population. Aims Our study aimed to establish accuracy for lung, chest, and abdominal ultrasound, individually and in combination, for TB diagnosis. Methods We conducted a prospective diagnostic accuracy study among consecutive adult out- and inpatients with probable TB in three German referral hospitals. We applied a comprehensive standardized ultrasound protocol. TB diagnosis was established by a microbiological reference standard including polymerase chain reaction and culture. Results A total of 102 participants originating from 30 different countries were enrolled. HIV prevalence was 7/99 (7%) and 73/102 (72%) had confirmed TB. TB was limited to the lungs in 15/34 (44%) of refugees and 27/39 (69%) in nonrefugees. Focused assessment with sonography for HIV-associated tuberculosis had a sensitivity of 40% (95% confidence interval [CI], 30-52) and specificity of 55% (95% CI, 38-72). Additional findings, such as small subpleural consolidations on LUS had a high sensitivity (88%; 95% CI, 78-93), but a low specificity (17%; 95% CI, 8-35). Larger consolidations in the lung apices had a sensitivity of 19% (95% CI, 12-30) and a specificity of 97% (95% CI, 83-100). Conclusions Our study establishes the first data on LUS performance against a comprehensive reference standard. Overall, our data suggest that ultrasound does not meet the requirements for triage but previously described and novel ultrasound targets in combination could aid in the clinical decision making.Registry: DRKS00026636.
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Affiliation(s)
- Stefan Fabian Weber
- Department for Infectious Disease and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany
- Department for Parasitology, University Hospital Heidelberg, Heidelberg, Germany
- German Center for Infectious Disease Research, DZIF Partner Site Heidelberg, Heidelberg, Germany
| | - Peter Wolf
- Department for Pneumology and Critical Care Medicine, Thoraxklinik Heidelberg, Heidelberg, Germany
| | - Nils Wetzstein
- Department 2 of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany
| | - Claus Küpper-Tetzel
- Department 2 of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany
| | - Maria Vehreschild
- Department 2 of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany
| | - Isabelle Suárez
- Department I of Internal Medicine, Division of Infectious Diseases, Medical Faculty and University Hospital of Cologne, University of Cologne, Cologne Germany
- German Center for Infectious Disease Research, DZIF Partner Site Cologne, Cologne, Germany
| | - Jan Rybniker
- Department I of Internal Medicine, Division of Infectious Diseases, Medical Faculty and University Hospital of Cologne, University of Cologne, Cologne Germany
- German Center for Infectious Disease Research, DZIF Partner Site Cologne, Cologne, Germany
- Center for Molecular Medicine Cologne, University of Cologne, Cologne, Germany
| | - Angela Klingmüller
- Department I of Internal Medicine, Division of Infectious Diseases, Medical Faculty and University Hospital of Cologne, University of Cologne, Cologne Germany
- German Center for Infectious Disease Research, DZIF Partner Site Cologne, Cologne, Germany
| | - Tim Weber
- Department of Diagnostic and Interventional Radiology, University Hospital Heidelberg, Heidelberg, Germany
| | - Maximilian Güttlein
- Department of Diagnostic and Interventional Radiology, University Hospital Heidelberg, Heidelberg, Germany
| | - Frank Tobian
- Department for Infectious Disease and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany
- German Center for Infectious Disease Research, DZIF Partner Site Heidelberg, Heidelberg, Germany
| | - Lisa Koeppel
- Department for Infectious Disease and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany
| | - Julia Selena Beck
- Department for Infectious Disease and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany
| | - Rebecca Wolf
- Department for Infectious Disease and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany
- German Center for Infectious Disease Research, DZIF Partner Site Heidelberg, Heidelberg, Germany
| | - Katharina Manten
- German Center for Infectious Disease Research, DZIF Partner Site Heidelberg, Heidelberg, Germany
- Department of Anaesthesiology, University Hospital Heidelberg, Heidelberg, Germany
| | - Stefan Zimmermann
- Department for Infectious Diseases, University Hospital Heidelberg, Institute of Medical Microbiology and Hygiene, Heidelberg, Germany
| | | | - Felix Herth
- Department for Pneumology and Critical Care Medicine, Thoraxklinik Heidelberg, Heidelberg, Germany
- Translational Lung Research Center Heidelberg, Heidelberg, Germany
| | - Sabine Bélard
- University of Tübingen, Institute of Tropical Medicine, Tübingen, Germany
- German Center for Infectious Disease Research, DZIF Partner Site Tübingen, Tübingen, Germany
| | - Claudia M Denkinger
- Department for Infectious Disease and Tropical Medicine, University Hospital Heidelberg, Heidelberg, Germany
- German Center for Infectious Disease Research, DZIF Partner Site Heidelberg, Heidelberg, Germany
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Álvarez Sánchez-Bayuela D, Fernández Martín J, Tiberi G, Ghavami N, Giovanetti González R, Cruz Hernánez LM, Aguilar Angulo PM, Martínez Gómez AD, Rodríguez Sánchez A, Bigotti A, Khalesi B, Pontoriero L, Calabrese M, Tagliafico AS, Romero Castellano C. Microwave imaging for breast cancer screening: protocol for an open, multicentric, interventional, prospective, non-randomised clinical investigation to evaluate cancer detection capabilities of MammoWave system on an asymptomatic population across multiple European countries. BMJ Open 2024; 14:e088431. [PMID: 39488412 PMCID: PMC11535703 DOI: 10.1136/bmjopen-2024-088431] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/06/2024] [Accepted: 09/30/2024] [Indexed: 11/04/2024] Open
Abstract
INTRODUCTION Microwave imaging presents several potential advantages including its non-ionising and harmless nature. This open, multicentric, interventional, prospective, non-randomised trial aims to validate MammoWave's artificial intelligence (AI)-based classification algorithm, leveraging microwave imaging, to achieve a sensitivity exceeding 75% and a specificity exceeding 90% in breast screening. METHODS AND ANALYSIS 10 000 volunteers undergoing regular mammographic breast cancer screening will be recruited across 9 European centres and invited to participate in the clinical study, involving MammoWave testing on both breasts. MammoWave results will be checked against the reference standard, to be intended as the output of conventional breast examination path (with histological confirmation of cancer cases) with 2 years follow-up. Anonymised clinical and MammoWave's results, including microwave images, associated features and a label provided by the AI-based classification algorithm, will be collected and stored in a dedicated electronic case report form. The prospective study will involve a comparative analysis between the output of the conventional breast examination path (control intervention) and the labels provided by MammoWave's AI system (experimental intervention). These labels will categorise breasts into two groups: breast With Suspicious Finding, indicating the presence of a suspicious lesion or No Suspicious Finding, indicating the absence of a lesion or the presence of a low-suspicion lesion. This trial aims to provide evidence regarding the novel MammoWave's AI system for detecting breast cancer in asymptomatic populations during screening. ETHICS AND DISSEMINATION This study was approved by the Research Ethics Committee of the Liguria Region (CET), Italy (CET-Liguria: 524/2023-DB id 13399), the Research Ethics Committee of Complejo Hospitalario de Toledo (CEIC), Spain (CEIC-1094), the National Ethics Committee for Clinical Research (CEIC), Portugal (CEIC-2311KC814), the Bioethical Committee of Pomeranian Medical University in Szczecin, Poland (KB-006/23/2024) and the Zurich Cantonal Ethics Commission, Switzerland (BASEC 2023-D0101). The findings of this study will be disseminated through academic and scientific conferences as well as peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT06291896.
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Affiliation(s)
- Daniel Álvarez Sánchez-Bayuela
- Instituto de Investigación Sanitaria de Castilla - La Mancha, Toledo, Spain
- University Hospital of Toledo, Servicio de Salud de Castilla - La Mancha, Toledo, Spain
| | - Juan Fernández Martín
- Instituto de Investigación Sanitaria de Castilla - La Mancha, Toledo, Spain
- University Hospital of Toledo, Servicio de Salud de Castilla - La Mancha, Toledo, Spain
| | - Gianluigi Tiberi
- London South Bank University, London, UK
- UBT - Umbria Bioengineering Technologies, Perugia, Italy
| | - Navid Ghavami
- UBT - Umbria Bioengineering Technologies, Perugia, Italy
| | - Rubén Giovanetti González
- Instituto de Investigación Sanitaria de Castilla - La Mancha, Toledo, Spain
- University Hospital of Toledo, Servicio de Salud de Castilla - La Mancha, Toledo, Spain
| | - Lina Marcela Cruz Hernánez
- Instituto de Investigación Sanitaria de Castilla - La Mancha, Toledo, Spain
- University Hospital of Toledo, Servicio de Salud de Castilla - La Mancha, Toledo, Spain
| | - Paul Martín Aguilar Angulo
- Instituto de Investigación Sanitaria de Castilla - La Mancha, Toledo, Spain
- University Hospital of Toledo, Servicio de Salud de Castilla - La Mancha, Toledo, Spain
| | - Aarón Darío Martínez Gómez
- Instituto de Investigación Sanitaria de Castilla - La Mancha, Toledo, Spain
- University Hospital of Toledo, Servicio de Salud de Castilla - La Mancha, Toledo, Spain
| | - Ana Rodríguez Sánchez
- Instituto de Investigación Sanitaria de Castilla - La Mancha, Toledo, Spain
- University Hospital of Toledo, Servicio de Salud de Castilla - La Mancha, Toledo, Spain
| | | | | | | | | | | | - Cristina Romero Castellano
- Instituto de Investigación Sanitaria de Castilla - La Mancha, Toledo, Spain
- University Hospital of Toledo, Servicio de Salud de Castilla - La Mancha, Toledo, Spain
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Ardiet DL, Nsio J, Komanda G, Coulborn RM, Grellety E, Grandesso F, Kitenge R, Ngwanga DL, Matady B, Manangama G, Mossoko M, Ngwama JK, Mbala P, Luquero F, Porten K, Ahuka-Mundeke S. Rapid Decision Algorithm for Patient Triage during Ebola Outbreaks. Emerg Infect Dis 2024; 30:1-11. [PMID: 39447210 PMCID: PMC11521189 DOI: 10.3201/eid3011.231650] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/26/2024] Open
Abstract
The low specificity of Ebola virus disease clinical signs increases the risk for nosocomial transmission to patients and healthcare workers during outbreaks. Reducing this risk requires identifying patients with a high likelihood of Ebola virus infection. Analyses of retrospective data from patients suspected of having Ebola virus infection identified 13 strong predictors and time from disease onset as constituents of a prediction score for Ebola virus disease. We also noted 4 highly predictive variables that could distinguish patients at high risk for infection, independent of their scores. External validation of this algorithm on retrospective data revealed the probability of infection continuously increased with the score.
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Affiliation(s)
| | | | - Gaston Komanda
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Rebecca M. Coulborn
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Emmanuel Grellety
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Francesco Grandesso
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Richard Kitenge
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Dolla L. Ngwanga
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Bibiche Matady
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Guyguy Manangama
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Mathias Mossoko
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - John K. Ngwama
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Placide Mbala
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Francisco Luquero
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Klaudia Porten
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
| | - Steve Ahuka-Mundeke
- Epicentre, Paris, France (D.-L. Ardiet, G. Komanda, R.M. Coulborn, E. Grellety, F. Grandesso, F. Luquero, K. Porten); Ministry of Health, Kinshasa, Democratic Republic of the Congo (J. Nsio, R. Kitenge, D.L. Ngwanga, B. Matady, M. Mossoko, J.K. Ngwama); Médecins Sans Frontières France, Paris (G. Manangama); Institut National de la Recherche Biomédicale, Kinshasa (P. Mbala, S. Ahuka-Mundeke); University of Kinshasa, Kinshasa (S. Ahuka-Mundeke)
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Lee JY, Kim DH, Kim SW, Im YH, Park CS, Kim DH, Alkhars Z, Kim SW. Diagnostic criteria for eosinophilic chronic rhinosinusitis: Comparative analysis and novel scoring system. Int Forum Allergy Rhinol 2024; 14:1746-1756. [PMID: 39039646 DOI: 10.1002/alr.23416] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/10/2024] [Revised: 06/25/2024] [Accepted: 07/05/2024] [Indexed: 07/24/2024]
Abstract
BACKGROUND Accurate identification of eosinophilic chronic rhinosinusitis is essentialg because its treatment and prognosis substantially differ from other subtypes. METHODS This retrospective observational study included 640 patients who underwent endoscopic sinus surgery for chronic rhinosinusitis in a single tertiary center from January 2021 to December 2022. Receiver operating characteristic curves were generated to compare accuracy, sensitivity, specificity of the novel scoring system, and previous diagnostic criteria (Japanese Epidemiological Survey of Refractory Eosinophilic Chronic Rhinosinusitis, European Forum for Research and Education in Allergy and Airway Diseases, European Position Paper on Rhinosinusitis and Nasal Polyps, and Sakuma et al.) for predicting eosinophilic chronic rhinosinusitis (ECRS) by tissue eosinophil count ≥70 per high power field. RESULTS Patients were randomly divided into estimation (n = 430) and validation (n = 210) groups. The area under the receiver operating characteristic curve for the novel score was 0.753 (95% confidence interval [CI], 0.670-0.835) in the estimation group, 0.729 (0.629-0.830) in the validation group, and 0.661 (0.584-0.738) in the 20-fold cross-validation with the entire dataset. CONCLUSIONS We propose a novel scoring system that incorporates three key parameters: "novel score = blood eosinophil (%) + total Lund-Mackay score of anterior ethmoid sinuses + 2 if nasal polyp present" greater than 7 can be reliably used for diagnosing ECRS. This system can facilitate decision-making processes regarding the administration of oral steroids and biologics targeting type 2 inflammation prior to surgical intervention.
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Affiliation(s)
- Jae Yoon Lee
- Department of Otolaryngology-Head and Neck Surgery, Seoul Saint Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
| | - Do Hyun Kim
- Department of Otolaryngology-Head and Neck Surgery, Seoul Saint Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
| | - Sung Won Kim
- Department of Otolaryngology-Head and Neck Surgery, Seoul Saint Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
| | - Yeon Hee Im
- Department of Otolaryngology-Head and Neck Surgery, Uijeongbu Saint Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, South Korea
| | - Chan Soon Park
- Department of Otolaryngology-Head and Neck Surgery, Saint Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, South Korea
| | - Dong Hyun Kim
- Department of Otolaryngology-Head and Neck Surgery, Incheon Saint Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, South Korea
| | - Zainab Alkhars
- Department of Otolaryngology-Head and Neck Surgery, Al Jabr Hospital, Ministry of Health, Al Ahsa, Saudi Arabia
| | - Soo Whan Kim
- Department of Otolaryngology-Head and Neck Surgery, Seoul Saint Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
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Staicu A, Albu C, Popa‐Stanila R, Bondor C, Chiriac L, Eniu D, Goidescu I, Florian AR, Surcel M, Cruciat G, Muresan D, Rotar I. Whole-body non-forensic fetal virtopsy using postmortem magnetic resonance imaging at 7 Tesla vs classical autopsy. ULTRASOUND IN OBSTETRICS & GYNECOLOGY : THE OFFICIAL JOURNAL OF THE INTERNATIONAL SOCIETY OF ULTRASOUND IN OBSTETRICS AND GYNECOLOGY 2024; 64:661-668. [PMID: 39376058 PMCID: PMC11579436 DOI: 10.1002/uog.29106] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/06/2023] [Revised: 08/13/2024] [Accepted: 08/15/2024] [Indexed: 10/09/2024]
Abstract
OBJECTIVE To determine the diagnostic accuracy of virtual autopsy using whole-body postmortem ultra-high field magnetic resonance imaging (MRI) at 7 Tesla (T), using a short T2-weighted imaging (T2-WI) protocol, compared with classical autopsy, for detecting structural abnormalities in small second-trimester fetuses. METHODS Thirty consecutive fetuses at 13-19 weeks' gestation (weight, 17-364 g) were included following spontaneous pregnancy loss or termination of pregnancy. After fixation in 10% formaldehyde solution (48 h to 1 week), all fetuses were scanned using a two-dimensional turbo high-resolution T2-WI protocol with multislice relaxation time, followed by an invasive autopsy. The diagnostic accuracy of virtual autopsy vs classical autopsy was calculated for 990 anatomical structures (30 fetuses × 33 items). Sensitivity, specificity, positive and negative predictive values and Cohen's κ coefficient of agreement, with their 95% CIs, as well as the McNemar test, were used to evaluate the accuracy and agreement of the two diagnostic methods. Analysis was stratified by anatomical segment (nervous, pulmonary, cardiovascular, digestive, renal, facial and skeletal) and across three gestational-age intervals (13-14, 15-16 and 17-19 weeks). RESULTS Considering classical autopsy as the gold standard, virtual autopsy had a sensitivity of 92.04% (95% CI, 85.42-96.29%) and a specificity of 97.87% (95% CI, 94.64-99.42%), with a positive predictive value of 96.30% (95% CI, 90.78-98.56%) and a negative predictive value of 95.34% (95% CI, 91.61-97.45%), achieving a diagnostic accuracy of 95.68% (95% CI, 92.73-97.68%) for detecting structural abnormalities in second-trimester fetuses. Cohen's κ for virtual vs classical autopsy was 0.907. The diagnostic ability of virtual autopsy at 7 T for malformed fetuses was superior to that of classical autopsy for analyzing the nervous system in small fetuses with pronounced autolysis, equivalent to that of classical autopsy when analyzing pulmonary, cardiovascular and renal systems and inferior when evaluating the fetal intestines. The sensitivity of virtual autopsy at 7 T for describing structural abnormalities increased with gestational age. CONCLUSION Virtual fetal autopsy using 7-T MRI and a turbo high-resolution T2-WI protocol with multislice relaxation time is a feasible postmortem diagnostic tool for the identification of fetal structural anomalies. © 2024 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
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Affiliation(s)
- A. Staicu
- Mother and Child Department, 1 Clinic of Obstetrics and Gynaecology‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
| | - C. Albu
- Department of Pathology‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
- Centre of Advanced Research StudiesEmergency County Hospital, IMOGENCluj‐NapocaRomania
| | - R. Popa‐Stanila
- Centre of Advanced Research StudiesEmergency County Hospital, IMOGENCluj‐NapocaRomania
- Department of Radiology‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
| | - C. Bondor
- Department of Medical Informatics and Biostatistics‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
| | - L. Chiriac
- Department of Medical Biophysics‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
- National Magnetic Resonance CentreBabeș Bolyai UniversityCluj‐NapocaRomania
- Faculty of PhysicsBabeș Bolyai UniversityCluj‐NapocaRomania
| | - D. Eniu
- Department of Medical Biophysics‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
| | - I. Goidescu
- Mother and Child Department, 1 Clinic of Obstetrics and Gynaecology‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
| | - A. R. Florian
- Mother and Child Department, 1 Clinic of Obstetrics and Gynaecology‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
| | - M. Surcel
- Mother and Child Department, 1 Clinic of Obstetrics and Gynaecology‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
| | - G. Cruciat
- Mother and Child Department, 1 Clinic of Obstetrics and Gynaecology‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
| | - D. Muresan
- Mother and Child Department, 1 Clinic of Obstetrics and Gynaecology‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
| | - I. Rotar
- Mother and Child Department, 1 Clinic of Obstetrics and Gynaecology‘Iuliu Haţieganu’ University of Medicine and PharmacyCluj‐NapocaRomania
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Roy A, Sukumar GM, Madegowda RK, Tamuli G, Pradeep BS. Validity and reliability of the new NIMHANS intellectual disability screening instrument (NID-Screener) for children and adolescents in India. Asian J Psychiatr 2024; 102:104282. [PMID: 39492081 DOI: 10.1016/j.ajp.2024.104282] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/18/2024] [Revised: 10/16/2024] [Accepted: 10/18/2024] [Indexed: 11/05/2024]
Abstract
INTRODUCTION There is a gap in tools specifically designed for assessing Intellectual Disability (ID) in Indian settings. To address this, the NIMHANS intellectual disability screening instrument (NID-Screener) was developed by the Department of Child and Adolescent Psychiatry, National Institute of Mental Health and Neuro Sciences. METHODS Ten non experts/language and ten experts rated face and content validity of NID-Screener respectively. Content validity was measured by Content Validity Ratio, Content Validity Indices (I-CVI, S-CVI) and Modified Kappa statistics. Construct validity was calculated by performing Exploratory Factor Analysis(EFA) on responses from 275 parent(s)/guardian(s) of children and adolescents (6-17 years). Criterion Validity was tested against Brief Intellectual Disability Scale (BIDS) and Clinical Diagnosis by Child and Adolescent Psychiatrist. Kappa Statistics was used to calculate inter - method and inter-Rater Reliability. Cronbach's alpha was used to assess Internal Consistency. This study was approved by NIMHANS ethics committee. RESULTS Findings revealed that NID-Screener has good face and content validity (S-CVI/Average = 0.917). Criterion Validity was excellent (Kappa Value=0.862, p-value<0.001) when compared with BIDS. Sensitivity and specificity were found to be 84.7 %, 89 % respectively against Clinical Diagnosis. On EFA, only one underlying factor with Eigen value > 1 was identified (55.8 % of total variance). Kappa value was found to be 0.971 and 0.942 for inter- rater and inter -method reliability respectively(p-value<0.001). NID-Screener has good internal consistency [Cronbach's alpha = 0.841]. CONCLUSIONS NID-Screener is a reliable and valid tool for screening ID among children and adolescents in India, facilitating its early detection through diagnostic assessments and subsequent interventions.
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Affiliation(s)
- Aaheli Roy
- Department of Epidemiology, Centre for Public Health, NIMHANS, Bengaluru, Karnataka, India
| | - Gautham M Sukumar
- Department of Epidemiology, Centre for Public Health, NIMHANS, Bengaluru, Karnataka, India
| | | | - Gayatri Tamuli
- Department of Epidemiology, Centre for Public Health, NIMHANS, Bengaluru, Karnataka, India
| | - Banandur S Pradeep
- Department of Epidemiology, Centre for Public Health, NIMHANS, Bengaluru, Karnataka, India
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Ullah N, Suchanta N, Pimpitak U, Santanirand P, Am-In N, Chaichanawongsaroj N. Validation of Recombinase Polymerase Amplification with In-House Lateral Flow Assay for mcr-1 Gene Detection of Colistin Resistant Escherichia coli Isolates. Antibiotics (Basel) 2024; 13:984. [PMID: 39452250 PMCID: PMC11505259 DOI: 10.3390/antibiotics13100984] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2024] [Revised: 10/14/2024] [Accepted: 10/15/2024] [Indexed: 10/26/2024] Open
Abstract
BACKGROUND/OBJECTIVES The emergence of the mobilized colistin resistance 1 (mcr-1) gene, which causes colistin resistance, is a serious concern in animal husbandry, particularly in pigs. Although antibiotic regulations in many countries have prohibited the use of colistin in livestock, the persistence and dissemination of this plasmid-mediated gene require effective and rapid monitoring. Therefore, a rapid, sensitive, and specific method combining recombinase polymerase amplification (RPA) with an in-house lateral flow assay (LFA) for the mcr-1 gene detection was developed. METHODS The colistin agar test and broth microdilution were employed to screen 152 E. coli isolates from pig fecal samples of five antibiotic-used farms. The established RPA-in-house LFA was validated with PCR for mcr-1 gene detection. RESULTS The RPA-in-house LFA was completed within 35 min (20 min of amplification and 5-15 min on LFA detection) at 37 °C. The sensitivity, specificity, and accuracy were entirely 100% in concordance with PCR results. No cross-reactivity was detected with seven common pathogenic bacteria or other mcr gene variants. CONCLUSIONS Therefore, the in-house RPA-LFA serves as a point-of-care testing tool that is rapid, simple, and portable, facilitating effective surveillance of colistin resistance in both veterinary and clinical settings, thereby enhancing health outcomes.
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Affiliation(s)
- Naeem Ullah
- Center of Excellence for Innovative Diagnosis of Antimicrobial Resistance, Department of Transfusion Medicine and Clinical Microbiology, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok 10330, Thailand; (N.U.); (N.S.)
| | - Nutchaba Suchanta
- Center of Excellence for Innovative Diagnosis of Antimicrobial Resistance, Department of Transfusion Medicine and Clinical Microbiology, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok 10330, Thailand; (N.U.); (N.S.)
| | - Umaporn Pimpitak
- Institute of Biotechnology and Genetic Engineering, Chulalongkorn University, Bangkok 10330, Thailand;
| | - Pitak Santanirand
- Department of Pathology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand;
| | - Nutthee Am-In
- Department of Obstetrics Gynaecology and Reproduction, Faculty of Veterinary Science, Chulalongkorn University, Bangkok 10330, Thailand;
| | - Nuntaree Chaichanawongsaroj
- Center of Excellence for Innovative Diagnosis of Antimicrobial Resistance, Department of Transfusion Medicine and Clinical Microbiology, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok 10330, Thailand; (N.U.); (N.S.)
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Laschinger J, Fuerst-Waltl B, Fuerst L, Linnenkohl S, Pesenhofer R, Kofler J. Evaluation of 'In-Parlour Scoring' (IPS) to Detect Lameness in Dairy Cows during Milking. Animals (Basel) 2024; 14:2870. [PMID: 39409819 PMCID: PMC11482633 DOI: 10.3390/ani14192870] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/19/2024] [Revised: 09/13/2024] [Accepted: 10/04/2024] [Indexed: 10/19/2024] Open
Abstract
The objective of this study was to evaluate the potential of 'In-Parlour Scoring' (IPS) as an alternative to locomotion scoring in herringbone, side-by-side, and tandem milking parlours in Austria. Between January and May 2023, a total of 990 observations were conducted on 495 cows across eleven Austrian dairy farms by two investigators working simultaneously but independently of each other. The observation criteria included shifting weight, claw conformation, and obvious disorders of the distal limb. Locomotion scoring was conducted on all cows within 24 h of assessment in the milking parlour using a scale of 1 to 5 (LCS 1: not lame; LCS 5: severely lame). Functional hoof trimming was performed within ten days after IPS. The following indicators were identified as useful for predicting lameness (LCS ≥ 3): shifting weight, abnormal weight distribution, swollen heel, hock joint or interdigital space, skin lesion on the lateral hock, claw position score, digital dermatitis lesions, short dorsal claw wall, and hyperextension of one claw. The reliability of the individual indicators for intra- and inter-rater assessment exhibited considerable variation ((weighted) kappa values: -0.0020-0.9651 and -0.0037-1.0, respectively). The specificity and sensitivity for the prediction of lame cows were calculated to be ≥ 96% and ≤ 24%, respectively. It was demonstrated that a one-time IPS has limited suitability for lameness assessment on Austrian dairy farms with herringbone, side-by-side, and tandem milking parlours.
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Affiliation(s)
- Jasmin Laschinger
- Clinical Department for Farm Animals and Food System Science, Clinical Center for Ruminant and Camelid Medicine, University of Veterinary Medicine Vienna, 1210 Vienna, Austria; (J.L.); (S.L.)
| | | | - Lisa Fuerst
- Faculty of Informatics, TU Wien, 1040 Vienna, Austria;
| | - Sophie Linnenkohl
- Clinical Department for Farm Animals and Food System Science, Clinical Center for Ruminant and Camelid Medicine, University of Veterinary Medicine Vienna, 1210 Vienna, Austria; (J.L.); (S.L.)
| | | | - Johann Kofler
- Clinical Department for Farm Animals and Food System Science, Clinical Center for Ruminant and Camelid Medicine, University of Veterinary Medicine Vienna, 1210 Vienna, Austria; (J.L.); (S.L.)
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Nartey YA, Yang JD, Zemla TJ, Ayawin J, Asibey SO, El-Kassas M, Bampoh SA, Duah A, Agyei-Nkansah A, Awuku YA, Afihene MY, Yamada H, Yin J, Plymoth A, Roberts LR. GALAD Score for the Diagnosis of Hepatocellular Carcinoma in Sub-Saharan Africa: A Validation Study in Ghanaian Patients. CANCER RESEARCH COMMUNICATIONS 2024; 4:2653-2659. [PMID: 39324700 PMCID: PMC11465414 DOI: 10.1158/2767-9764.crc-24-0227] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/18/2024] [Revised: 08/10/2024] [Accepted: 09/24/2024] [Indexed: 09/27/2024]
Abstract
Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide including sub-Saharan Africa. The GALAD score, derived from Gender, Age, Lens culinaris agglutinin-reactive fraction of alpha fetoprotein, Alpha fetoprotein, and Des-carboxy-prothrombin, has high accuracy in diagnosing HCC in Asia, Europe, and North America; however, it has not been validated in an African cohort. The aim of this study was to assess the performance of the GALAD score in the diagnosis of HCC in sub-Saharan Africa. Clinical data from patients with cirrhosis (n = 93) or HCC (n = 78) from outpatient hepatology clinics at three teaching hospitals in Ghana were abstracted, and serum samples were analyzed. A logistic regression model predicting HCC status based on the GALAD score was constructed to obtain the ROC curve for GALAD. The AUC with 95% confidence interval (CI) was calculated. The median GALAD score was higher among patients with HCC versus cirrhosis controls (8.0 vs. -4.1, P < 0.01). The AUC of the GALAD score for HCC detection was 0.86 (95% CI, 0.79-0.92). At a cut-off value of -0.37, the GALAD score had a sensitivity of 0.81 and a specificity of 0.86. The AUC (95% CI) was 0.87 (0.80-0.95) and 0.81 (0.67-0.94) in hepatitis B virus-positive and hepatitis B virus-negative patients, respectively. The GALAD score has a high accuracy for HCC detection. It has great potential to improve HCC surveillance in sub-Saharan Africa where imaging resources are limited. Significance: The GALAD score or its relevant modifications have the potential to aid in improving HCC surveillance efforts in low-resource settings in sub-Saharan Africa. This could enhance early detection rates of HCC and potentially improve survival rates in resource-limited settings.
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Affiliation(s)
- Yvonne Ayerki Nartey
- Department of Internal Medicine, Cape Coast Teaching Hospital, Cape Coast, Ghana.
- Department of Internal Medicine and Therapeutics, School of Medical Sciences, University of Cape Coast, Cape Coast, Ghana.
| | - Ju Dong Yang
- Karsh Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center, Los Angeles, California.
| | - Tyler J. Zemla
- Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota.
| | - Joshua Ayawin
- Department of Internal Medicine, Komfo-Anokye Teaching Hospital, Kumasi, Ghana.
| | | | - Mohamed El-Kassas
- Department of Endemic Medicine, Faculty of Medicine, Helwan University, Cairo, Egypt.
| | - Sally Afua Bampoh
- Department of Internal Medicine, Greater Accra Regional Hospital, Accra, Ghana.
| | - Amoako Duah
- Department of Internal Medicine, University of Ghana Medical Center, Accra, Ghana.
| | - Adwoa Agyei-Nkansah
- Department of Internal Medicine, University of Ghana Medical School, Accra, Ghana.
| | - Yaw Asante Awuku
- Department of Internal Medicine, University of Health and Allied Sciences, Ho, Ghana.
| | - Mary Yeboah Afihene
- Department of Internal Medicine, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
| | - Hiroyuki Yamada
- Division of In Vitro Diagnostics, FUJIFILM Corporation, Tokyo, Japan.
| | - Jun Yin
- Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.
| | - Amelie Plymoth
- European Centre for Disease Prevention and Control (ECDC), Stockholm, Sweden.
| | - Lewis R. Roberts
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
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Vigdal ØN, Flugstad S, Storheim K, Killingmo RM, Grotle M. Predictive validity of the STarT Back screening tool among older adults with back pain. Eur J Pain 2024; 28:1559-1570. [PMID: 38752601 DOI: 10.1002/ejp.2281] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/17/2022] [Revised: 03/04/2024] [Accepted: 04/29/2024] [Indexed: 11/05/2024]
Abstract
BACKGROUND The predictive validity of the STarT Back screening tool among older adults is uncertain. This study aimed to assess the predictive validity of the SBT among older adults in primary care. METHODS This prospective cohort study included 452 patients aged ≥55 years seeking Norwegian primary care with a new episode of back pain. A poor outcome (persistent disabling back pain) was defined as a score of ≥7/24 on the Roland-Morris Disability Questionnaire (RMDQ) at 3, 6 or 12 months of follow-up. The ability of the SBT risk groups to identify persistent disabling back pain was assessed with multivariable logistic regression, area under receiver operating characteristics curve (AUC), and with the accuracy measures sensitivity, specificity, predictive values and likelihood ratios. RESULTS The adjusted odds ratios (95% CI) for persistent disabling back pain were 2.40 (1.34-4.30) at 3 months, 3.42 (1.76-6.67) at 6 months and 2.81 (1.47-5.38) at 12 months for the medium-risk group (n = 118), and 8.90 (1.83-43.24), 2.66 (0.81-8.67) and 4.53 (1.24-16.46) for the high-risk group (n = 27), compared to the low-risk group (n = 282). There were no statistically significant differences in odds between the medium- and high-risk groups at any time point. AUC values (95% CI) were 0.65 (0.59-0.71), 0.67 (0.60-0.73) and 0.65 (0.58-0.71) at 3, 6 and 12 months. Accuracy measures were poor at all time points, with particularly poor sensitivity and negative likelihood ratio values. CONCLUSION The predictive validity of the SBT risk groups in predicting persistent disabling back pain in older adults was poor. SIGNIFICANCE STATEMENT This study found that the STarT Back screening tool had poor predictive validity among older adults and that it may need recalibration or extension before widespread implementation among older adults. Having valid tools for this population may aid clinicians with allocating scarce healthcare resources, which is especially important considering the rapidly ageing population and its expected challenge to the healthcare systems.
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Affiliation(s)
- Ørjan Nesse Vigdal
- Department of Rehabilitation Science and Health Technology, Faculty of Health Science, OsloMet - Oslo Metropolitan University, Oslo, Norway
| | - Solveig Flugstad
- Department of Rehabilitation Science and Health Technology, Faculty of Health Science, OsloMet - Oslo Metropolitan University, Oslo, Norway
| | - Kjersti Storheim
- Department of Rehabilitation Science and Health Technology, Faculty of Health Science, OsloMet - Oslo Metropolitan University, Oslo, Norway
- Research and Communication Unit for Musculoskeletal Health (FORMI), Division of Clinical Neuroscience, Oslo University Hospital, Oslo, Norway
| | - Rikke Munk Killingmo
- Department of Rehabilitation Science and Health Technology, Faculty of Health Science, OsloMet - Oslo Metropolitan University, Oslo, Norway
| | - Margreth Grotle
- Department of Rehabilitation Science and Health Technology, Faculty of Health Science, OsloMet - Oslo Metropolitan University, Oslo, Norway
- Research and Communication Unit for Musculoskeletal Health (FORMI), Division of Clinical Neuroscience, Oslo University Hospital, Oslo, Norway
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Ulvin LB, Nilsen KB, Taubøll E, Etholm L, Heuser K. Sensitivity and specificity of the Salzburg EEG criteria for nonconvulsive status epilepticus. Ann Clin Transl Neurol 2024; 11:2685-2695. [PMID: 39186316 PMCID: PMC11514898 DOI: 10.1002/acn3.52184] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/02/2024] [Revised: 07/02/2024] [Accepted: 08/07/2024] [Indexed: 08/27/2024] Open
Abstract
OBJECTIVE The Salzburg EEG criteria for nonconvulsive status epilepticus (NCSE) have been proposed as consensus criteria for NCSE. We aimed to perform an independent study of their diagnostic accuracy. METHODS A prospective study was carried out at Oslo University Hospital, including all consecutive patients ≥15 years old who were referred for an EEG with an explicit or implicit question of NCSE from February 2020 to February 2022. Two independent EEG readers scored the included EEGs according to the Salzburg criteria and blinded to the clinical data. The reference standard was defined as the clinical diagnosis the patient received based on all available clinical and paraclinical data. Diagnostic accuracy in identifying "certain/possible NCSE" was assessed by calculating sensitivity, specificity, positive predictive value, and negative predictive value with their 95% confidence intervals. RESULTS In total, 469 patients/EEGs were included in the study. The prevalence of NCSE according to the reference standard was 11% (n = 53). The criteria showed a sensitivity of 94% (95% CI: 92-96%), a specificity of 77% (95% CI: 73-81%), a positive predictive value of 34% (95% CI: 30-39%), and a negative predictive value of 99% (95% CI: 98-100%). False positives for "certain NCSE" (n = 16) included many serial seizures and stimulus-induced rhythmic and periodic discharges (SIRPIDs), as well as a focal cortical dysplasia. False positives for "possible NCSE" (n = 79) were mainly represented by different encephalopathies and postictality. INTERPRETATION The low specificity of the Salzburg criteria calls for refinement before implementation into daily clinical practice.
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Affiliation(s)
- Line B. Ulvin
- Section for Clinical Neurophysiology, Department of NeurologyOslo University HospitalOsloNorway
- Institute of Clinical Medicine, University of OsloOsloNorway
| | - Kristian B. Nilsen
- Section for Clinical Neurophysiology, Department of NeurologyOslo University HospitalOsloNorway
| | - Erik Taubøll
- Institute of Clinical Medicine, University of OsloOsloNorway
- Department of NeurologyOslo University HospitalOsloNorway
| | - Lars Etholm
- Section for Clinical Neurophysiology, Department of NeurosurgeryOslo University HospitalOsloNorway
| | - Kjell Heuser
- Department of NeurologyOslo University HospitalOsloNorway
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Pradhan M, Mandal A, Biswas BK, Hazra A, Kumar D. The Role of Fine-Needle Aspiration Cytology in the Evaluation of Breast Lumps. Cureus 2024; 16:e70748. [PMID: 39493056 PMCID: PMC11531062 DOI: 10.7759/cureus.70748] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/03/2024] [Indexed: 11/05/2024] Open
Abstract
Background Breast cancer is the most frequently diagnosed cancer in women worldwide, accounting for more than one in ten new cancer cases each year. It ranks as the second leading cause of cancer-related mortality among women. The majority of patients present with palpable breast lumps. Effective surgical management of breast cancer largely depends on accurate preoperative pathological diagnosis. This study evaluates the diagnostic accuracy and prognostic implications of fine-needle aspiration cytology (FNAC) compared with core needle biopsy (CNB) in breast carcinoma. Objectives The objectives of this study are to assess the sensitivity and specificity of FNAC and CNB, to compare the diagnostic accuracy of FNAC and CNB against histopathological findings from gross specimens in the evaluation of breast lumps, and to identify and examine the limitations associated with both FNAC and CNB procedures. Materials and methods This study included female patients presenting with clinically suspicious palpable breast lumps at the General Surgery OPD of Bankura Sammilani Medical College and Hospital, Bankura. All patients underwent FNAC followed by CNB. The cytological and CNB diagnoses were compared with the final pathological diagnosis obtained from excisional biopsy. Results The study included 44 female patients aged 20 to 70 years. The most common age group for breast carcinoma was 50-59 years (36.36%). Malignancy was diagnosed in 75% of cases (33/44), with right breast involvement (65%) being more common than the left. The upper outer quadrant (59%) was the most frequently affected area. Among the 33 confirmed malignant cases, 69.70% had lesions larger than 5 cm. FNAC demonstrated a sensitivity of 93.93%, specificity of 100%, positive predictive value (PPV) of 100%, negative predictive value (NPV) of 84.61%, and diagnostic accuracy of 95.45%. CNB showed a sensitivity of 96.97%, specificity of 100%, PPV of 100%, NPV of 91.67%, and diagnostic accuracy of 97.73%. Both methods correlated significantly with the final histopathology results (p < 0.05). FNAC identified ductal carcinoma in 93.55% of cases, while CNB identified it in 96.77%. Conclusion CNB provides additional information on receptor status but is more resource-intensive. FNAC remains a cost-effective and time-efficient first-line diagnostic tool, especially in resource-constrained settings like rural India. FNAC should be employed for initial diagnosis, with CNB reserved for cases requiring further clarification.
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Affiliation(s)
- Mohan Pradhan
- General Surgery, Bankura Sammilani Medical College and Hospital, Bankura, IND
| | - Arnab Mandal
- General Surgery, Bankura Sammilani Medical College and Hospital, Bankura, IND
| | - Biplab K Biswas
- Pathology and Laboratory Medicine, Bankura Sammilani Medical College and Hospital, Bankura, IND
| | - Anirban Hazra
- General Surgery, Bankura Sammilani Medical College and Hospital, Bankura, IND
| | - Deepak Kumar
- General Surgery, Calcutta National Medical College and Hospital, Kolkata, IND
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Midzi H, Naicker T, Vengesai A, Mabaya L, Muchesa P, Mduluza-Jokonya TL, Katerere AG, Kapanga D, Kasambala M, Mutapi F, Mduluza T. Assessment of urine metabolite biomarkers for the detection of S. haematobium infection in pre-school aged children in a rural community in Zimbabwe. Acta Trop 2024; 258:107327. [PMID: 39127139 DOI: 10.1016/j.actatropica.2024.107327] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/09/2023] [Revised: 07/15/2024] [Accepted: 07/16/2024] [Indexed: 08/12/2024]
Abstract
BACKGROUND Early diagnosis of urogenital schistosomiasis is key to its control and elimination. The current gold standard microscopic examination techniques lack sensitivity in detecting light Schistosomiasis infections in pre-school aged children thus it is urgent to develop diagnostic tools that may be integrated into control programs. In this study, we evaluated the diagnostic performance of urine metabolite biomarkers using a chemical reagent strip in the detection of S. haematobium infection in pre-school aged children. METHODS A case-control study was conducted involving 82 pre-school aged children that were age and sex matched. Urine samples were collected for 3 consecutive days and were evaluated using urine filtration gold techniques as the gold standard method. The samples were simultaneously measured for metabolite biomarkers specifically haematuria, proteins, ketones, nitrites, glucose, bilirubin and urobilinogen using chemical reagent strips. Pearson correlation test was used to measure the relationship between S. haematobium infection and the urine metabolite biomarkers. RESULTS The diagnostic performance of urine biomarkers were correlated with the microscopic examination urine filtration technique. Haematuria (r = 0.592, p = 0.0001) and proteinuria (r = 0.448, p = 0.0001) were correlated to S. haematobium infection. Negative correlations with p > 0.05 were recorded for ketones and urobilinogen. Highest sensitivity was 65.9 % (CI, 49.4 - 79.9) for haematuria whilst protein (albumin) biomarker had a lower specificity value of 43.9 % (28.5 - 60.3). Inversely, highest sensitivity was 87.8 % (73.8 - 95.9) for proteinuria whilst haematuria had a lower sensitivity value of 82.9 % (67.9 - 92.8). The positive predictive values ranged from 57.7 % (41.6 - 72.2) to 79.4 % (65.5 - 88.7) whereas negative predictive values ranged from 70.8 % (60.8 - 79.2) to 52.0 % (48.7 - 55.3). With respect to diagnostic efficiency, haematuria had a fair diagnostic performance with an area under the curve of 0.76 followed by proteinuria with proteinuria whilst the remaining metabolites fail discriminating ability with an area under the curve of <0.5. CONCLUSION Although haematuria and protein biomarkers in urine are moderately sensitive and specific, they are important morbidity indicators of urogenital schistosomiasis in pre-school aged that may be utilised during screening in schistosomiasis control programs. We recommend comprehensive analysis of biomarkers using metabolomics techniques to identify novel urine biomarkers.
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Affiliation(s)
- Herald Midzi
- Department of Biochemistry and Biotechnology, University of Zimbabwe, Harare, Zimbabwe; Optics & Imaging, Doris Duke Medical Research Institute, College of Health Sciences, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.
| | - Thajasvarie Naicker
- Optics & Imaging, Doris Duke Medical Research Institute, College of Health Sciences, University of KwaZulu-Natal, KwaZulu-Natal, South Africa
| | - Arthur Vengesai
- Faculty of Medicine and Health Sciences, Department of Biochemistry, Midlands State University, Gweru, Zimbabwe
| | - Lucy Mabaya
- Midlands State University, National Pathology Research and Diagnostic Centre, Gweru, Zimbabwe
| | - Petros Muchesa
- Water and Health Research Centre, University of Johannesburg, South Africa
| | - Tariro L Mduluza-Jokonya
- Optics & Imaging, Doris Duke Medical Research Institute, College of Health Sciences, University of KwaZulu-Natal, KwaZulu-Natal, South Africa; Faculty of Medicine and Health Science, University of Zimbabwe, Harare, Zimbabwe
| | | | - Donald Kapanga
- Midlands State University, National Pathology Research and Diagnostic Centre, Gweru, Zimbabwe
| | - Maritha Kasambala
- Department of Biological Sciences and Ecology, University of Zimbabwe, Harare, Zimbabwe
| | - Francisca Mutapi
- Ashworth Laboratories, Institute for Immunology and Infection Research and Centre for Immunity, Infection and Evolution, School of Biological Sciences, University of Edinburgh, Edinburgh, Scotland , United Kingdom
| | - Takafira Mduluza
- Department of Biochemistry and Biotechnology, University of Zimbabwe, Harare, Zimbabwe
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Jørgensen K, Nielsen TR, Nielsen A, Oxbøll AB, Gerner SD, Waldorff FB, Waldemar G. Diagnostic accuracy of the Brief Assessment of Impaired Cognition case-finding instrument in a general practice setting and comparison with other widely used brief cognitive tests-a cross-validation study. Eur J Neurol 2024; 31:e16418. [PMID: 39045891 DOI: 10.1111/ene.16418] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2024] [Revised: 07/04/2024] [Accepted: 07/09/2024] [Indexed: 07/25/2024]
Abstract
BACKGROUND AND PURPOSE The aim of this study was to examine the discriminative validity of the Brief Assessment of Impaired Cognition (BASIC) case-finding instrument in a general practice (GP) setting and compare it with other widely used brief cognitive instruments. METHODS Patients aged ≥70 years were prospectively recruited from 14 Danish GP clinics. Participants were classified as having either normal cognition (n = 154) or cognitive impairment (n = 101) based on neuropsychological test performance, reported instrumental activities of daily living, and concern regarding memory decline. Comparisons involved the Mini-Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA), the Rowland Universal Dementia Assessment Scale (RUDAS), the Mini-Cog, the 6-item Clock Drawing Test (CDT-6) and the BASIC Questionnaire (BASIC-Q). RESULTS BASIC demonstrated good overall classification accuracy with an area under the receiver operating characteristic curve (AUC) of 0.88 (95% confidence interval [CI] 0.84-0.92), a sensitivity of 0.72 (95% CI 0.62-0.80) and a specificity of 0.86 (95% CI 0.79-0.91). Pairwise comparisons of the AUCs of BASIC, MMSE, MoCA and RUDAS produced non-significant results, but BASIC had significantly higher classification accuracy than Mini-Cog, BASIC-Q and CDT-6. Depending on the pretest probability of cognitive impairment, the positive predictive validity of BASIC varied from 0.83 to 0.36, and the negative predictive validity from 0.97 to 0.76. CONCLUSIONS BASIC demonstrated good discriminative validity in a GP setting. The classification accuracy of BASIC is equivalent to more complex, time-consuming instruments, such as the MMSE, MoCA and RUDAS, and higher than very brief instruments, such as the CDT-6, Mini-Cog and BASIC-Q.
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Affiliation(s)
- Kasper Jørgensen
- Danish Dementia Research Centre, Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark
| | - T Rune Nielsen
- Danish Dementia Research Centre, Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark
- Department of Psychology, University of Copenhagen, Copenhagen, Denmark
| | - Ann Nielsen
- Danish Dementia Research Centre, Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark
| | - Anne-Britt Oxbøll
- Danish Dementia Research Centre, Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark
| | - Sofie D Gerner
- Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
| | - Frans B Waldorff
- Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
| | - Gunhild Waldemar
- Danish Dementia Research Centre, Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
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Llinas A, Paredes E, Sol J, Palacin JM, Solanes M, Martinez J, Florensa C, Llort L, Castañ MT, Gracia MI, Paül JM, Ortega Bravo M, Llor C. Impact of Lung Ultrasound along with C-Reactive Protein Point-of-Care Testing on Clinical Decision-Making and Perceived Usefulness in Routine Healthcare for Patients with Lower Respiratory Tract Infections: Protocol for Analytical Observational Study. J Clin Med 2024; 13:5770. [PMID: 39407829 PMCID: PMC11476663 DOI: 10.3390/jcm13195770] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/31/2024] [Revised: 09/21/2024] [Accepted: 09/26/2024] [Indexed: 10/20/2024] Open
Abstract
Background: Lower respiratory tract infections (LRTIs) are a significant cause of primary care consultations. Differentiating between viral and bacterial infections is critical for effective treatment and to minimize unnecessary antibiotic use. This study investigates the impact of combining lung ultrasound (LUS) with capillary blood C-reactive protein (CRP) rapid testing on clinical decision-making for patients with LRTIs. Objectives: The primary objective is to assess how the integration of CRP testing and LUS influences antibiotic prescription decisions. The study aims to quantify the percentage change in antibiotic prescriptions before and after performing LUS, following history taking, clinical examination, and CRP testing. Methods: This analytical observational study will be conducted in six primary care centers within the Health Region of Lleida, Catalonia, serving a mixed urban and rural population of approximately 105,000 residents. The study will recruit 196 patients aged 18 and over, presenting with LRTI symptoms and not treated with antibiotics in the preceding 14 days. Participants will undergo CRP testing followed by LUS during their consultation. Statistical analyses, including linear regression, bivariate analysis, Pearson or Spearman correlation, and logistic regression, will be used to evaluate the impact of LUS on clinical decisions and its predictive value in diagnosing bacterial infections. Results and Conclusions: This study will provide insights into the role of LUS combined with CRP testing in improving diagnostic accuracy and guiding antibiotic prescription decisions in primary care. The findings aim to enhance treatment protocols for LRTIs, reducing unnecessary antibiotic use and improving patient outcomes.
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Affiliation(s)
- Anna Llinas
- Onze de Setembre Primary Care Centre, Institut Català de la Salut, 25005 Lleida, Spain
- GRECOCAP Research Group, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Centro de Investigación Biomédica en Red (CIBER) en Enfermedades Infecciosas, Instituto de Salud Carlos III, 28029 Madrid, Spain
| | - Eugeni Paredes
- Onze de Setembre Primary Care Centre, Institut Català de la Salut, 25005 Lleida, Spain
- Department of Medicine, Faculty of Medicine, University of Lleida, 25003 Lleida, Spain
| | - Joaquim Sol
- Research Support Unit Lleida, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Department of Experimental Medicine, University of Lleida-Biomedical Research Institute of Lleida (UdL-IRBLleida), 25003 Lleida, Spain
| | - Jose Maria Palacin
- Onze de Setembre Primary Care Centre, Institut Català de la Salut, 25005 Lleida, Spain
- GRECOCAP Research Group, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Research Support Unit Lleida, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
| | - Monica Solanes
- Onze de Setembre Primary Care Centre, Institut Català de la Salut, 25005 Lleida, Spain
- GRECOCAP Research Group, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
| | - Javier Martinez
- GRECOCAP Research Group, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Balaguer Primary Care Centre, Institut Català de la Salut, 25600 Lleida, Spain
| | - Carme Florensa
- GRECOCAP Research Group, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Borges Blanques Primary Care Centre, Institut Català de la Salut, 25400 Lleida, Spain
| | - Laia Llort
- GRECOCAP Research Group, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Borges Blanques Primary Care Centre, Institut Català de la Salut, 25400 Lleida, Spain
| | - Maria Teresa Castañ
- GRECOCAP Research Group, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Rambla de Ferran Primary Care Centre, Institut Català de la Salut, 25007 Lleida, Spain
| | - Maria Isabel Gracia
- Rambla de Ferran Primary Care Centre, Institut Català de la Salut, 25007 Lleida, Spain
| | - Josep Miquel Paül
- GRECOCAP Research Group, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Cervera Primary Care Centre, Institut Català de la Salut, 25200 Lleida, Spain
| | - Marta Ortega Bravo
- GRECOCAP Research Group, University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Almacelles Primary Care Centre, Institut Català de la Salut, 25100 Lleida, Spain
| | - Carl Llor
- University Institute in Primary Care Research Jordi Gol, 08007 Barcelona, Spain
- Centro de Investigación Biomédica en Red (CIBER) en Enfermedades Infecciosas, Instituto de Salud Carlos III, 28029 Madrid, Spain
- Department of Public Health, General Practice, Faculty of Medicine, University of Southern Denmark, 5000 Odense, Denmark
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Vieira PPMG, Braga JAP, Regacini R. Lung ultrasound score to predict development of acute chest syndrome in children with sickle cell disease. Hematol Transfus Cell Ther 2024:S2531-1379(24)00322-5. [PMID: 39366888 DOI: 10.1016/j.htct.2024.07.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/16/2024] [Revised: 05/18/2024] [Accepted: 07/09/2024] [Indexed: 10/06/2024] Open
Abstract
OBJECTIVE This study aims to identify lung ultrasound (LUS) findings associated with acute chest syndrome (ACS) at the time of admission and 24-48 h later, to compare these to chest radiography (CXR) findings and to establish a score to predict the development of this pulmonary complication in sickle cell disease (SCD) children METHODS: A prospective observational study of SCD children presenting signs or symptoms of ACS evaluated by LUS and CXR at admission and 24-48 h later. A score was conceived to predict the evolution of ACS during hospitalization based on ultrasonographic findings. RESULTS Seventy-eight children were evaluated; 61 (78.2 %) developed ACS. A score greater than one at admission showed sensitivity, specificity, accuracy, and positive predictive value (PPV) of 75.4 %, 88.2 %, 78.2 %, and 95.8 %, respectively to predict ACS, while only 32 (52.5 %) CXR showed alterations. The development of ACS during hospitalization was unlikely for a score of zero and very likely for a score greater than one at admission. Regarding follow-up exams, a score greater than one showed sensitivity, specificity, accuracy, and PPV of 98.4 %, 76.5 %, 93.6 %, and 92.8 %, respectively to predict the development of ACS. ACS development was very unlikely for a score of zero and very likely for a score greater than zero in the follow-up. CONCLUSION LUS is an effective tool to assess risk for the development of ACS in SCD children with clinical suspicion.
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Affiliation(s)
- Pedro P M G Vieira
- Escola Paulista de Medicina da Universidade Federal de São Paulo (EPM UNIFESP), São Paulo, SP, Brazil.
| | - Josefina A P Braga
- Escola Paulista de Medicina da Universidade Federal de São Paulo (EPM UNIFESP), São Paulo, SP, Brazil
| | - Rodrigo Regacini
- Escola Paulista de Medicina da Universidade Federal de São Paulo (EPM UNIFESP), São Paulo, SP, Brazil
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Ditzel FL, Hut SCA, van den Boogaard M, Boonstra M, Leijten FSS, Wils EJ, van Nesselrooij T, Kromkamp M, Rood PJT, Röder C, Bouvy PF, Coesmans M, Osse RJ, Pop-Purceleanu M, van Dellen E, Krulder JWM, Milisen K, Faaij R, Vondeling AM, Kamper AM, van Munster BC, de Jonghe A, Winters MAM, van der Ploeg J, van der Zwaag S, Koek DHL, Drenth-van Maanen CAC, Beishuizen A, van den Bos DM, Cahn W, Schuit E, Slooter AJC. DeltaScan for the Assessment of Acute Encephalopathy and Delirium in ICU and non-ICU Patients, a Prospective Cross-Sectional Multicenter Validation Study. Am J Geriatr Psychiatry 2024; 32:1093-1104. [PMID: 38171949 DOI: 10.1016/j.jagp.2023.12.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/06/2023] [Revised: 12/06/2023] [Accepted: 12/06/2023] [Indexed: 01/05/2024]
Abstract
OBJECTIVES To measure the diagnostic accuracy of DeltaScan: a portable real-time brain state monitor for identifying delirium, a manifestation of acute encephalopathy (AE) detectable by polymorphic delta activity (PDA) in single-channel electroencephalograms (EEGs). DESIGN Prospective cross-sectional study. SETTING Six Intensive Care Units (ICU's) and 17 non-ICU departments, including a psychiatric department across 10 Dutch hospitals. PARTICIPANTS 494 patients, median age 75 (IQR:64-87), 53% male, 46% in ICUs, 29% delirious. MEASUREMENTS DeltaScan recorded 4-minute EEGs, using an algorithm to select the first 96 seconds of artifact-free data for PDA detection. This algorithm was trained and calibrated on two independent datasets. METHODS Initial validation of the algorithm for AE involved comparing its output with an expert EEG panel's visual inspection. The primary objective was to assess DeltaScan's accuracy in identifying delirium against a delirium expert panel's consensus. RESULTS DeltaScan had a 99% success rate, rejecting 6 of the 494 EEG's due to artifacts. Performance showed and an Area Under the Receiver Operating Characteristic Curve (AUC) of 0.86 (95% CI: 0.83-0.90) for AE (sensitivity: 0.75, 95%CI=0.68-0.81, specificity: 0.87 95%CI=0.83-0.91. The AUC was 0.71 for delirium (95%CI=0.66-0.75, sensitivity: 0.61 95%CI=0.52-0.69, specificity: 72, 95%CI=0.67-0.77). Our validation aim was an NPV for delirium above 0.80 which proved to be 0.82 (95%CI: 0.77-0.86). Among 84 non-delirious psychiatric patients, DeltaScan differentiated delirium from other disorders with a 94% (95%CI: 87-98%) specificity. CONCLUSIONS DeltaScan can diagnose AE at bedside and shows a clear relationship with clinical delirium. Further research is required to explore its role in predicting delirium-related outcomes.
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Affiliation(s)
- Fienke L Ditzel
- Department of Intensive Care Medicine and UMC Utrecht Brain Center (FLD, SCAH, MB, DMB, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
| | - Suzanne C A Hut
- Department of Intensive Care Medicine and UMC Utrecht Brain Center (FLD, SCAH, MB, DMB, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Mark van den Boogaard
- Department of Intensive Care Medicine (MB, PJTR), Radboud university medical center, Nijmegen, the Netherlands
| | - Michel Boonstra
- Department of Intensive Care Medicine and UMC Utrecht Brain Center (FLD, SCAH, MB, DMB, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Frans S S Leijten
- Department of Clinical Neurophysiology and UMC Utrecht Brain Center (FSSL), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Evert-Jan Wils
- Department of Intensive Care (E-JW), Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands
| | - Tim van Nesselrooij
- Department of Psychiatry and UMC Utrecht Brain Center (TN, MK, CR, ED, WC, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Marjan Kromkamp
- Department of Psychiatry and UMC Utrecht Brain Center (TN, MK, CR, ED, WC, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Paul J T Rood
- Department of Intensive Care Medicine (MB, PJTR), Radboud university medical center, Nijmegen, the Netherlands; HAN University of Applied Sciences (PJTR), School of Health Studies, Research Department of Emergency and Critical Care, Nijmegen, the Netherlands
| | - Christian Röder
- Department of Psychiatry and UMC Utrecht Brain Center (TN, MK, CR, ED, WC, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Paul F Bouvy
- Department of Psychiatry (PFB, MC, RJO), Erasmus Medical Center Rotterdam, Rotterdam, the Netherlands
| | - Michiel Coesmans
- Department of Psychiatry (PFB, MC, RJO), Erasmus Medical Center Rotterdam, Rotterdam, the Netherlands
| | - Robert Jan Osse
- Department of Psychiatry (PFB, MC, RJO), Erasmus Medical Center Rotterdam, Rotterdam, the Netherlands
| | - Monica Pop-Purceleanu
- Department of Psychiatry (MP-P), Radboud University Medical Center, Nijmegen, the Netherlands
| | - Edwin van Dellen
- Department of Psychiatry and UMC Utrecht Brain Center (TN, MK, CR, ED, WC, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Neurology (ED, AJCS), UZ Brussel and Vrije Universiteit Brussel, Brussels, Belgium
| | - Jaap W M Krulder
- Department of Geriatrics (JWMK), Franciscus Gasthuis&Vlietland, Rotterdam, the Netherlands
| | - Koen Milisen
- Department of Public Health and Primary Care (KM), Academic Center for Nursing and Midwifery, Katholieke Univerisiteit Leuven - University of Leuven, Leuven, Belgium; Department of Geriatric Medicine (KM), University Hospitals Leuven, Leuven, Belgium
| | - Richard Faaij
- Department of Geriatrics (RF, AMV), Diakonessenhuis, Utrecht, the Netherlands
| | - Ariël M Vondeling
- Department of Geriatrics (RF, AMV), Diakonessenhuis, Utrecht, the Netherlands
| | - Ad M Kamper
- Department of Geriatrics (AK, MAMW, JP, SZ), Isala, Zwolle, the Netherlands
| | - Barbara C van Munster
- Department of Internal Medicine/Geriatrics (BCM), University Center of Geriatric Medicine, University Medical Center of Groningen, Groningen, the Netherlands; Alzheimer Center Groningen (BCM), Groningen, the Netherlands
| | | | - Marian A M Winters
- Department of Geriatrics (AK, MAMW, JP, SZ), Isala, Zwolle, the Netherlands
| | | | | | - Dineke H L Koek
- Department of Geriatrics (DHLK, CACDM), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Clara A C Drenth-van Maanen
- Department of Geriatrics (DHLK, CACDM), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Albertus Beishuizen
- Department of Intensive Care Medicine (AB), Medical Spectrum Twente, Enschede, the Netherlands
| | - Deirdre M van den Bos
- Department of Intensive Care Medicine and UMC Utrecht Brain Center (FLD, SCAH, MB, DMB, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Wiepke Cahn
- Department of Psychiatry and UMC Utrecht Brain Center (TN, MK, CR, ED, WC, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Ewoud Schuit
- Julius Center for Health Sciences and Primary Care (ES), University Medical Center Utrecht, Utrecht University, the Netherlands
| | - Arjen J C Slooter
- Department of Intensive Care Medicine and UMC Utrecht Brain Center (FLD, SCAH, MB, DMB, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Psychiatry and UMC Utrecht Brain Center (TN, MK, CR, ED, WC, AJCS), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Neurology (ED, AJCS), UZ Brussel and Vrije Universiteit Brussel, Brussels, Belgium
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Wiyanad A, Thaweewannakij T, Intaruk R, Namwong W, Amatachaya S. Walking speed to determine walking performance of people with mobility limitations from a developing country. Physiother Theory Pract 2024; 40:1925-1932. [PMID: 37357957 DOI: 10.1080/09593985.2023.2227256] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/18/2023] [Revised: 05/26/2023] [Accepted: 05/29/2023] [Indexed: 06/27/2023]
Abstract
BACKGROUND The criteria to determine walking performance of people with mobility limitations from developed countries have been already reported. However, these criteria may not be suitable to be applied for people with mobility limitations from developing countries due to the differences in sociodemographic characteristics and environmental conditions. OBJECTIVE To explore cutoff points of walking speed to determine walking performance of individuals with mobility limitations from a developing country. METHODS Individuals with mobility limitations from a developing country (n = 136) were cross-sectionally interviewed and assessed for their demographics and walking performance. Then they were assessed for their walking speed using the 10-meter walk test. RESULTS Walking speeds of ≥0.30 m/s, ≥ 0.40 m/s, and ≥0.65 m/s could optimally indicate the ability of outside-home walking, limited-community walking, and full-community walking, respectively (sensitivity = 78%-84%, specificity = 81%-93%, and area under the receiver operating characteristic curve [AUC] > 0.90). Moreover, a walking speed of ≥0.35 m/s could suggest the ability of functional walking (sensitivity = 78%; specificity = 83%; and AUC = 0.89). CONCLUSIONS With the need of standard practical measure for early screening and monitoring of functional alteration over time, the present walking speed cutoff points may be clinically applied to suggest walking performance in daily living specifically for individuals with mobility limitations from a developing country.
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Affiliation(s)
- Arpassanan Wiyanad
- School of Physical Therapy, Khon Kaen University, Khon Kaen, Thailand
- Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand
| | - Thiwabhorn Thaweewannakij
- School of Physical Therapy, Khon Kaen University, Khon Kaen, Thailand
- Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand
| | - Roongnapa Intaruk
- School of Physical Therapy, Khon Kaen University, Khon Kaen, Thailand
- Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand
| | - Wilairat Namwong
- School of Physical Therapy, Khon Kaen University, Khon Kaen, Thailand
- Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand
| | - Sugalya Amatachaya
- School of Physical Therapy, Khon Kaen University, Khon Kaen, Thailand
- Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand
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48
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Wang X, Chen L, Lyu M, Wei N. The optimal cut-off values of screening tools for dynapenia: a cross-sectional study. Disabil Rehabil 2024; 46:4540-4545. [PMID: 37897320 DOI: 10.1080/09638288.2023.2274884] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2023] [Revised: 10/17/2023] [Accepted: 10/20/2023] [Indexed: 10/30/2023]
Abstract
PURPOSE This study evaluated whether anthropometric measurements and the five times sit-to-stand test could be used to identify dynapenia. The cut-off values of accurate screening tools for identifying dynapenia were also established. MATERIALS AND METHODS This was a cross-sectional study conducted on individuals ≥ 60 years old (N = 529). All participants underwent handgrip strength measurement, anthropometric measurements and the five times sit-to-stand test. The participants whose handgrip strength was < 28 kg for men and < 18 kg for women were considered to have dynapenia. The association between the recorded variables and dynapenia was determined using logistic regression, and cut-off values were established by performing the Receiver Operating Characteristic curve analysis. RESULTS The prevalence of dynapenia was 35.42% in men and 25.61% in women. For males, both calf circumference (≤ 35.2 cm) and the five times sit-to-stand test (≥ 14.6 s) could be used as accurate tools for dynapenia. For females, only the five times sit-to-stand test (≥ 11.8 s) had sufficient accuracy to be used as a screening tool for dynapenia. CONCLUSIONS The five times sit-to-stand test was an accurate screening tool for identifying dynapenia. The calf circumference could be only used as a screening tool in males.
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Affiliation(s)
- Xinxin Wang
- Department of Nursing, College of Medicine and Health Science, Wuhan Polytechnic University, Wuhan, Hubei, China
| | - Ling Chen
- Department of Nursing, College of Medicine and Health Science, Wuhan Polytechnic University, Wuhan, Hubei, China
| | - Mengyu Lyu
- Department of Nursing, College of Medicine and Health Science, Wuhan Polytechnic University, Wuhan, Hubei, China
| | - Ning Wei
- Department of Rehabilitation Sciences, College of Medicine and Health Science, Wuhan Polytechnic University, Wuhan, Hubei, China
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49
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Qin ZZ, Van der Walt M, Moyo S, Ismail F, Maribe P, Denkinger CM, Zaidi S, Barrett R, Mvusi L, Mkhondo N, Zuma K, Manda S, Koeppel L, Mthiyane T, Creswell J. Computer-aided detection of tuberculosis from chest radiographs in a tuberculosis prevalence survey in South Africa: external validation and modelled impacts of commercially available artificial intelligence software. Lancet Digit Health 2024; 6:e605-e613. [PMID: 39033067 PMCID: PMC11339183 DOI: 10.1016/s2589-7500(24)00118-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2022] [Revised: 04/19/2024] [Accepted: 06/03/2024] [Indexed: 07/23/2024]
Abstract
BACKGROUND Computer-aided detection (CAD) can help identify people with active tuberculosis left undetected. However, few studies have compared the performance of commercially available CAD products for screening in high tuberculosis and high HIV settings, and there is poor understanding of threshold selection across products in different populations. We aimed to compare CAD products' performance, with further analyses on subgroup performance and threshold selection. METHODS We evaluated 12 CAD products on a case-control sample of participants from a South African tuberculosis prevalence survey. Only those with microbiological test results were eligible. The primary outcome was comparing products' accuracy using the area under the receiver operating characteristic curve (AUC) against microbiological evidence. Threshold analyses were performed based on pre-defined criteria and across all thresholds. We conducted subgroup analyses including age, gender, HIV status, previous tuberculosis history, symptoms presence, and current smoking status. FINDINGS Of the 774 people included, 516 were bacteriologically negative and 258 were bacteriologically positive. Diverse accuracy was noted: Lunit and Nexus had AUCs near 0·9, followed by qXR, JF CXR-2, InferRead, Xvision, and ChestEye (AUCs 0·8-0·9). XrayAME, RADIFY, and TiSepX-TB had AUC under 0·8. Thresholds varied notably across these products and different versions of the same products. Certain products (Lunit, Nexus, JF CXR-2, and qXR) maintained high sensitivity (>90%) across a wide threshold range while reducing the number of individuals requiring confirmatory diagnostic testing. All products generally performed worst in older individuals, people with previous tuberculosis, and people with HIV. Variations in thresholds, sensitivity, and specificity existed across groups and settings. INTERPRETATION Several previously unevaluated products performed similarly to those evaluated by WHO. Thresholds differed across products and demographic subgroups. The rapid emergence of products and versions necessitates a global strategy to validate new versions and software to support CAD product and threshold selections. FUNDING Government of Canada.
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Affiliation(s)
- Zhi Zhen Qin
- Stop TB Partnership, Geneva, Switzerland; Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, German Center for Infection Research (partner site), Heidelberg, Germany.
| | | | - Sizulu Moyo
- Human Sciences Research Council, Human and Social Capabilities Division, Cape Town, South Africa
| | - Farzana Ismail
- National Institute for Communicable Diseases, Pretoria, South Africa
| | - Phaleng Maribe
- Human Sciences Research Council, Human and Social Capabilities Division, Cape Town, South Africa
| | - Claudia M Denkinger
- Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, German Center for Infection Research (partner site), Heidelberg, Germany
| | | | | | - Lindiwe Mvusi
- South African National Department of Health, Cape Town, South Africa
| | | | - Khangelani Zuma
- Human Sciences Research Council, Human and Social Capabilities Division, Cape Town, South Africa
| | - Samuel Manda
- South Africa Medical Research Council, Pretoria, South Africa
| | - Lisa Koeppel
- Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, German Center for Infection Research (partner site), Heidelberg, Germany
| | - Thuli Mthiyane
- South Africa Medical Research Council, Pretoria, South Africa
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50
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Lin M, Wang P, Lu B, Jin M, Tan J, Liu W, Yuan J, Peng X, Chen Y. Development and evaluation of a rapid visual loop-mediated isothermal amplification assay for the tcdA gene in Clostridioides difficile detection. PeerJ 2024; 12:e17776. [PMID: 39224820 PMCID: PMC11368091 DOI: 10.7717/peerj.17776] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/28/2023] [Accepted: 06/28/2024] [Indexed: 09/04/2024] Open
Abstract
Background The tcdA gene codes for an important toxin produced by Clostridioides difficile (C. difficile), but there is currently no simple and cost-effective method of detecting it. This article establishes and validates a rapid and visual loop-mediated isothermal amplification (LAMP) assay for the detection of the tcdA gene. Methods Three sets of primers were designed and optimized to amplify the tcdA gene in C. difficile using a LAMP assay. To evaluate the specificity of the LAMP assay, C. difficile VPI10463 was used as a positive control, while 26 pathogenic bacterial strains lacking the tcdA gene and distilled water were utilized as negative controls. For sensitivity analysis, the LAMP assay was compared to PCR using ten-fold serial dilutions of DNA from C. difficile VPI10463, ranging from 207 ng/µl to 0.000207 pg/µl. The tcdA gene of C.difficile was detected in 164 stool specimens using both LAMP and polymerase chain reaction (PCR). Positive and negative results were distinguished using real-time monitoring of turbidity and chromogenic reaction. Results At a temperature of 66 °C, the target DNA was successfully amplified with a set of primers designated, and visualized within 60 min. Under the same conditions, the target DNA was not amplified with the tcdA12 primers for 26 pathogenic bacterial strains that do not carry the tcdA gene. The detection limit of LAMP was 20.700 pg/µl, which was 10 times more sensitive than that of conventional PCR. The detection rate of tcdA in 164 stool specimens using the LAMP method was 17% (28/164), significantly higher than the 10% (16/164) detection rate of the PCR method (X2 = 47, p < 0.01). Conclusion LAMP method is an effective technique for the rapid and visual detection of the tcdA gene of C. difficile, and shows potential advantages over PCR in terms of speed, simplicity, and sensitivity. The tcdA-LAMP assay is particularly suitable for medical diagnostic environments with limited resources and is a promising diagnostic strategy for the screening and detection of C. difficile infection in populations at high risk.
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Affiliation(s)
- Minyi Lin
- Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-Sen University, Zhuhai, China
| | - Pu Wang
- Department of Gastroenterology, Guangdong Provincial Key Laboratory of Gastroenterology, State Key Laboratory of Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - Bingyun Lu
- Integrative Microecology Center, Shenzhen Key Laboratory of Gastrointestinal Microbiota and Disease, Shenzhen Clinical Research Center for Digestive Disease, Shenzhen Technology Research Center of Gut Microbiota Transplantation, Shenzhen Hospital, Southern Medical University, Shenzhen, China
| | - Ming Jin
- Integrative Microecology Center, Shenzhen Key Laboratory of Gastrointestinal Microbiota and Disease, Shenzhen Clinical Research Center for Digestive Disease, Shenzhen Technology Research Center of Gut Microbiota Transplantation, Shenzhen Hospital, Southern Medical University, Shenzhen, China
| | - Jiasheng Tan
- Department of Gastroenterology, SongShan Lake Central Hospital of Dongguan City, Dongguan, Guangdong, China
| | - Wei Liu
- Institute of Disease Control and Prevention, Academy of Military Medical Sciences, Beijing, China
| | - Jing Yuan
- Institute of Disease Control and Prevention, Academy of Military Medical Sciences, Beijing, China
| | - Xiaomou Peng
- Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-Sen University, Zhuhai, China
| | - Ye Chen
- Integrative Microecology Center, Shenzhen Key Laboratory of Gastrointestinal Microbiota and Disease, Shenzhen Clinical Research Center for Digestive Disease, Shenzhen Technology Research Center of Gut Microbiota Transplantation, Shenzhen Hospital, Southern Medical University, Shenzhen, China
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