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Veenstra J, Boothby-Shoemaker W, Friedman BJ. Response to "Appropriate Statistical Methods to Assess Cross-Study Diagnostic 23-Gene Expression Profile Test Performance for Cutaneous Melanocytic Neoplasms". Am J Dermatopathol 2025; 47:497-498. [PMID: 40314646 DOI: 10.1097/dad.0000000000002983] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/03/2025]
Affiliation(s)
- Jesse Veenstra
- Department of Dermatology, Henry Ford Hospital, Detroit, MI
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Stahlmann K, Kellerhuis B, Reitsma JB, Dendukuri N, Zapf A. Comparison of methods to handle missing values in a continuous index test in a diagnostic accuracy study - a simulation study. BMC Med Res Methodol 2025; 25:147. [PMID: 40426044 PMCID: PMC12107930 DOI: 10.1186/s12874-025-02594-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2025] [Accepted: 05/12/2025] [Indexed: 05/29/2025] Open
Abstract
BACKGROUND Most diagnostic accuracy studies have applied a complete case analysis (CCA) or single imputation approach to address missing values in the index test, which may lead to biased results. Therefore, this simulation study aims to compare the performance of different methods in estimating the AUC of a continuous index test with missing values in a single-test diagnostic accuracy study. METHODS We simulated data for a reference standard, continuous index test, and three covariates using different sample sizes, prevalences of the target condition, correlations between index test and covariates, and true AUCs. Subsequently, missing values were induced for the continuous index test, assuming varying proportions of missing values and missingness mechanisms. Seven methods (multiple imputation (MI), empirical likelihood, and inverse probability weighting approaches) were compared to a CCA in terms of their performance to estimate the AUC given missing values in the index test. RESULTS Under missing completely at random (MCAR) and many missing values, CCA gives good results for a small sample size and all methods perform well for a large sample size. If missing values are missing at random (MAR), all methods are severely biased if the sample size and prevalence are small. An augmented inverse probability weighting method and standard MI methods perform well with higher prevalence and larger sample size, respectively. Most methods give biased results if missing values are missing not at random (MNAR) and the correlation or the sample size and prevalence are low. Methods using the covariates improve with increasing correlation. CONCLUSIONS Most methods perform well if the proportion of missing values is small. Given a higher proportion of missing values and MCAR, we would recommend to conduct a CCA and standard MI methods for a small and large sample size, respectively. In the absence of better alternatives we recommend to conduct a CCA and to discuss its limitations, if the sample size is small, and missing values are M(N)AR. Standard MI methods and the augmented inverse probability approach may be a good alternative, if the sample size and/or correlation increases. All methods are biased under MNAR and a low correlation.
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Affiliation(s)
- Katharina Stahlmann
- Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg Eppendorf, Hamburg, Germany.
| | - Bastiaan Kellerhuis
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
- Blavatnik School of Government, University of Oxford, Oxford, UK
| | - Johannes B Reitsma
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
| | | | - Antonia Zapf
- Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg Eppendorf, Hamburg, Germany
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Behroozi Z, Hassani D, Mobini M, Bahadori T, Peyghami K, Judaki MA, Khoshnoodi J, Amiri MM, Golsaz-Shirazi F, Shokri F. Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA. Biologicals 2025; 90:101819. [PMID: 39892062 DOI: 10.1016/j.biologicals.2025.101819] [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: 11/06/2024] [Revised: 01/08/2025] [Accepted: 01/24/2025] [Indexed: 02/03/2025] Open
Abstract
Despite global vaccination efforts, hepatitis B virus (HBV) infection remains a major health threat, causing over a million deaths annually. Hepatitis B e-antigen (HBeAg) is an indicator of HBV replication and high infectivity. HBeAg is an essential serological marker for monitoring response to treatment and/or determining the stage of chronic HBV infection. Here, we produced a panel of mouse hybridomas secreting monoclonal antibodies (MAbs) to HBeAg by fusing a mouse myeloma cell line with splenocytes from mice immunized with recombinant HBeAg. Anti-HBe MAbs were then characterized by competition ELISA and Western blotting. We designed and optimized an in-house sandwich ELISA using HBeAg-specific rabbit polyclonal and mouse monoclonal antibodies. The diagnostic performance of the assay was then compared to a commercial HBeAg detection ELISA kit using 176 HBeAg[-] and 44 HBeAg[+] serum samples, showing a significant positive correlation (r = 0.8250; P < 0.0001). The in-house ELISA showed reasonable sensitivity (97.56 %) and specificity (99.40 %), with a cut-off value and area under the curve of 0.193 and 0.9884, respectively. Additionally, the assay showed high repeatability, with intra- and inter-assay coefficients of variation of 2.46 % and 11.38 %, respectively. Our designed HBeAg-detecting sandwich ELISA has the potential for use in clinical diagnosis.
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Affiliation(s)
- Zeinab Behroozi
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Danesh Hassani
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Maryam Mobini
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Tannaz Bahadori
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Kiana Peyghami
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Mohammad Ali Judaki
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Jalal Khoshnoodi
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Mohammad Mehdi Amiri
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Forough Golsaz-Shirazi
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
| | - Fazel Shokri
- Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
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Hameed M, James C, Wong K, Lewis P, Roberson P, Schmitz K, Jayappa S, Rowell A, McVay-Gilam M, Frost T, Springer A, Moore M. G-tube contrast check: Transition from fluoroscopy to abdominal radiographs. RESEARCH SQUARE 2024:rs.3.rs-5632134. [PMID: 39764097 PMCID: PMC11703343 DOI: 10.21203/rs.3.rs-5632134/v1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Indexed: 01/19/2025]
Abstract
Background Reports of radiographic exam evaluation for G-tube malposition in children are limited. Objective Evaluate effectiveness of a new 2-view abdominal radiograph exam protocol instituted to provide 24/7 coverage at 2 affiliated hospitals and replace the prior fluoroscopic G-tube contrast check exam. Materials and Methods G-tube radiographic exams performed between December 2019 and May 2022 at 2 affiliated hospitals were identified and retrospective chart review was performed to delineate exam test yield, accuracy, sensitivity, specificity. Additional data collected included exam adherence to protocol, years of experience of the reporting pediatric radiologist, reporting time, and 30-day adverse events. Results 227 exams were performed in 186 patients. 2-view radiograph protocol was followed in 81.9% (186/227); Additional radiograph views were performed in 18.1% (41/227); additional contrast volume in 9.3% (21/227). Reporting time under 1 hour occurred in 79.7% (181/227). 5.7% (13/227) exams were reported as indeterminate adding a median time delay of 40 minutes (IQR 90). Indeterminate exam reporting did not correlate with years of experience of the reporting pediatric radiologist (p=0.19); reporting time over 1 hour occurred more often in the after-hours group (p= 0.032). Fluoroscopic G-tube contrast check was requested in 8 of 13 indeterminate readings. Following reclassification of indeterminate exams based on clinical suspicion, test performance: yield 94.3%, accuracy 97.3%, sensitivity 81.8%, specificity 98.2%, PPV 69.2%, NPV 99.1%. Conclusion This new diagnostic exam performed well with high test yield, accuracy, specificity and negative predictive value. The exam mostly followed protocol, allowed timely resumption of G-tube use, and provided a needed 24/7 remote coverage option for the new affiliated hospital.
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Affiliation(s)
| | | | - Kevin Wong
- University of Arkansas for Medical Sciences
| | - Paul Lewis
- University of Arkansas for Medical Sciences
| | | | | | | | | | | | | | | | - Mary Moore
- University of Arkansas for Medical Sciences
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Wesali S, Molinaro A, Lindkvist B, Hedenström P, Sadik R. Endoscopic ultrasound is useful for the risk stratification of mucinous pancreatic cystic lesions: A long-term prospective study. Pancreatology 2024:S1424-3903(24)00834-2. [PMID: 39741057 DOI: 10.1016/j.pan.2024.12.006] [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: 02/07/2024] [Revised: 11/18/2024] [Accepted: 12/13/2024] [Indexed: 01/02/2025]
Abstract
OBJECTIVES The aims of this prospective observational study were to test worrisome features on endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) as a stratification tool in patients with mucinous pancreatic cystic lesions (PCLs), and to assess these patients' long-term risk of adenocarcinoma and mortality. METHODS Patients with suspected PCLs on cross-sectional imaging who underwent EUS-FNA at Sahlgrenska University Hospital between February 2007 and February 2018 were consecutively enrolled. The main inclusion criterion was the final diagnosis of a mucinous PCL. The results from EUS-FNA were analyzed in the context of outcome gathered from medical records of follow-up until February 2021. RESULTS Of 334 patients undergoing EUS-FNA, 171 (51 %) had a final diagnosis of a mucinous PCL. 29/171 (17 %) patients were diagnosed with HGD or adenocarcinoma <6 months after EUS-FNA, with 28/29 (97 %) patients having at least one worrisome feature on EUS-FNA. A solid component in mucinous PCLs on EUS was independently associated with the presence of HGD or adenocarcinoma (OR 23.6, 95 % CI 6.1-91.6, p < .001). A total of 4/142 (3 %) patients developed adenocarcinoma during the follow-up period (median = 61.4 months). Overall, in 80/82 (98 %) of the patients without worrisome features on EUS-FNA, HGD or adenocarcinoma was not detected. Six of the 21 (29 %) patients with HGD or adenocarcinoma who underwent surgery as initial management died from pancreatic cancer during follow-up. CONCLUSIONS EUS-FNA is useful for the risk stratification of mucinous PCLs. The low incidence of adenocarcinoma over time after a negative EUS-FNA may allow for a less resource intensive surveillance strategy.
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Affiliation(s)
- Sahar Wesali
- Department of Gastroenterology and Hepatology, Sahlgrenska University Hospital, Gothenburg, Sweden.
| | - Antonio Molinaro
- Department of Gastroenterology and Hepatology, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Björn Lindkvist
- Department of Gastroenterology and Hepatology, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Per Hedenström
- Department of Gastroenterology and Hepatology, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Riadh Sadik
- Department of Gastroenterology and Hepatology, Sahlgrenska University Hospital, Gothenburg, Sweden
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AlRaddadi KK, Al-Shoaibi AM, Alnaqeep A, Almohamady W, Almutairi MM, AbdelAziz M, Aly MM. Traumatic thoracic spine fracture: can we predict when MRI would modify the fracture classification or decision-making compared to CT alone? EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2024; 33:3685-3694. [PMID: 38568281 DOI: 10.1007/s00586-024-08196-8] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/05/2023] [Revised: 12/05/2023] [Accepted: 02/13/2024] [Indexed: 10/16/2024]
Abstract
PURPOSE To determine the impact of magnetic resonance imaging (MRI) on fracture classification for thoracic spine fractures (TSFs) compared to computed tomography (CT) alone. METHODS This study was a retrospective review of 63 consecutive patients with TSFs who underwent CT and MRI within ten days of injury. Three reviewers classified all fractures according to the AOSpine Classification and the Thoracolumbar AOSpine Injury severity score (TLAOSIS). Posterior ligamentous complex (PLC) injury on MRI was defined by "black stripe discontinuity" and on CT by the presence of vertebral body translation, facet joint malalignment, horizontal laminar or spinous process fracture, and interspinous widening. The proportion of patients with AO type A/B/C and with TLAOSIS ≤ 5 and ≥ 6 was compared between CT and MRI. Classification and regression trees were used to create a series of predictive models for the probability of PLC injury in AO type A fractures. RESULTS AO classification using CT was as follows: type A in 35 patients (55%), type B in 18 patients (29%), and type C in 10 patients (16%). Thirty-three patients (52%) had a TLAOSIS ≤5, while the remaining 30 (48%) had TLAOSI ≥6. The addition of MRI after CT upgraded type A to type B fractures in 10 patients (16%) and changed TL AOSIS from ≤5 to ≥6 in 8 cases (12.8%). Type A fractures with load sharing score (LSC) ≥6 had a 60% chance of upgrading to type B, while LSC <6 had a 12.5% chance of upgrading to type B. CONCLUSIONS CT yielded (89%) accuracy in diagnosing PLC injury in TSFs. The addition of MRI after CT substantially changed the AO classification or TLAOISS, compared to CT alone, thus suggesting an added value of MRI for PLC assessment for TSFs classification.
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Affiliation(s)
- Khulood K AlRaddadi
- Department of Neurosurgery, National Neuroscience Institute, King Fahad Medical City, Riyadh, Saudi Arabia
- Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, 54146, 11514, Riyadh, Saudi Arabia
| | - Abdulbaset M Al-Shoaibi
- Department of Diagnostic Radiology, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
| | - Abdelwahed Alnaqeep
- Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, 54146, 11514, Riyadh, Saudi Arabia
| | - Waleed Almohamady
- Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, 54146, 11514, Riyadh, Saudi Arabia
| | - Meshari M Almutairi
- Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, 54146, 11514, Riyadh, Saudi Arabia
| | | | - Mohamed M Aly
- Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, 54146, 11514, Riyadh, Saudi Arabia.
- Department of Neurosurgery, Mansoura University, Mansoura, Egypt.
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Pan Z, Qin Y, Bai W, He Q, Yin X, He J. Implementing multiple imputations for addressing missing data in multireader multicase design studies. BMC Med Res Methodol 2024; 24:217. [PMID: 39333923 PMCID: PMC11428558 DOI: 10.1186/s12874-024-02321-3] [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: 03/06/2024] [Accepted: 08/27/2024] [Indexed: 09/30/2024] Open
Abstract
BACKGROUND In computer-aided diagnosis (CAD) studies utilizing multireader multicase (MRMC) designs, missing data might occur when there are instances of misinterpretation or oversight by the reader or problems with measurement techniques. Improper handling of these missing data can lead to bias. However, little research has been conducted on addressing the missing data issue within the MRMC framework. METHODS We introduced a novel approach that integrates multiple imputation with MRMC analysis (MI-MRMC). An elaborate simulation study was conducted to compare the efficacy of our proposed approach with that of the traditional complete case analysis strategy within the MRMC design. Furthermore, we applied these approaches to a real MRMC design CAD study on aneurysm detection via head and neck CT angiograms to further validate their practicality. RESULTS Compared with traditional complete case analysis, the simulation study demonstrated the MI-MRMC approach provides an almost unbiased estimate of diagnostic capability, alongside satisfactory performance in terms of statistical power and the type I error rate within the MRMC framework, even in small sample scenarios. In the real CAD study, the proposed MI-MRMC method further demonstrated strong performance in terms of both point estimates and confidence intervals compared with traditional complete case analysis. CONCLUSION Within MRMC design settings, the adoption of an MI-MRMC approach in the face of missing data can facilitate the attainment of unbiased and robust estimates of diagnostic capability.
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Affiliation(s)
- Zhemin Pan
- Tongji University School of Medicine, 1239 Siping Road, Yangpu District, Shanghai, 200092, China
| | - Yingyi Qin
- Department of Military Health Statistics, Naval Medical University, 800 Xiangyin Road, Yangpu District, Shanghai, 200433, China
| | - Wangyang Bai
- Tongji University School of Medicine, 1239 Siping Road, Yangpu District, Shanghai, 200092, China
| | - Qian He
- Department of Military Health Statistics, Naval Medical University, 800 Xiangyin Road, Yangpu District, Shanghai, 200433, China
| | - Xiaoping Yin
- Department of Radiology, the Affiliated Hospital of Hebei University, 212 Eastern Yuhua Road, Baoding City, Hebei Province, 071000, China
| | - Jia He
- Tongji University School of Medicine, 1239 Siping Road, Yangpu District, Shanghai, 200092, China.
- Department of Military Health Statistics, Naval Medical University, 800 Xiangyin Road, Yangpu District, Shanghai, 200433, China.
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Rey-Mota J, Escribano-Colmena G, Fernández-Lucas J, Parraca JA, Clemente-Suárez VJ. Impact of professional experience on clinical judgment and muscular response in various neuromuscular tests. Physiol Behav 2024; 283:114602. [PMID: 38851442 DOI: 10.1016/j.physbeh.2024.114602] [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: 05/23/2024] [Revised: 05/30/2024] [Accepted: 06/05/2024] [Indexed: 06/10/2024]
Abstract
Muscle testing is an integral component in assessing musculoskeletal function and tailoring rehabilitation efforts. This study aimed i. to identify an objective evaluation system sensitive to analyze changes in different muscular conditions in different neuromuscular tests across a spectrum of professional experience levels; and ii. to analyze differences in objective parameters and clinical judgment between participants of different levels of expertise in different muscular conditions in different neuromuscular tests. Participants included 60 subjects with Level I to III expertise who performed blinded neuromuscular tests on the middle deltoid and rectus femoris muscles of 40 volunteer subjects. The methodology centered on standardizing test protocols to minimize variability, employing EMG to quantify muscle activity, thermography to capture thermographic muscular response, and digital dynamometry to measure muscular resistance. The findings revealed that while traditional methods like thermography and electromyography provide valuable insights, digital dynamometry stands out for its sensitivity in detecting muscle condition changes in neuromuscular test. Moreover, the data underscored the pivotal role of advanced training and expertise in enhancing the precision and accuracy of neuromuscular diagnostics, since there were significant differences in objective parameters and clinical judgment between participants of different levels of expertise in the different muscular conditions in Middle deltoid and Rectus femoris neuromuscular tests analyzed, presenting higher expertise participant clinical judgment like objective validated instrument.
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Affiliation(s)
| | | | - Jesús Fernández-Lucas
- Applied Biotechnology Group, Universidad Europea de Madrid, Urbanización El Bosque, 28670, Villaviciosa de Odón, Spain; Grupo de Investigación en Ciencias Naturales y Exactas, GICNEX, Universidad de la Costa, CUC, Calle 58 # 55-66, 080002, Barranquilla, Colombia; Department of Biochemistry and Molecular Biology, Faculty of Biology, Universidad Complutense de Madrid, Calle José Antonio Novais, 12, 28040 Madrid, Spain.
| | - Jose A Parraca
- Departamento de Desporto e Saúde, Escola de Saúde e Desenvolvimento Humano, Universidade de Évora, 7004 516 Évora, Portugal; Comprehensive Health Research Centre (CHRC), University of Évora, 7004-516 Évora, Portugal
| | - Vicente Javier Clemente-Suárez
- Grupo de Investigación en Cultura, Educación y Sociedad, Universidad de la Costa, 080002 Barranquilla, Colombia; Universidad Europea de Madrid. Faculty of Sports Sciences. Tajo Street, s/n, 28670 Madrid, Spain
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An R, Avanaki A, Thota P, Nemade S, Mehta A, Gurkan UA. Point-of-Care Diagnostic Test for Beta-Thalassemia. BIOSENSORS 2024; 14:83. [PMID: 38392002 PMCID: PMC10886532 DOI: 10.3390/bios14020083] [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: 10/06/2023] [Revised: 01/15/2024] [Accepted: 01/16/2024] [Indexed: 02/24/2024]
Abstract
Hemoglobin (Hb) disorders are among the most common monogenic diseases affecting nearly 7% of the world population. Among various Hb disorders, approximately 1.5% of the world population carries β-thalassemia (β-Thal), affecting 40,000 newborns every year. Early screening and a timely diagnosis are essential for β-thalassemia patients for the prevention and management of later clinical complications. However, in Africa, Southern Europe, the Middle East, and Southeast Asia, where β-thalassemia is most prevalent, the diagnosis and screening for β-thalassemia are still challenging due to the cost and logistical burden of laboratory diagnostic tests. Here, we present Gazelle, which is a paper-based microchip electrophoresis platform that enables the first point-of-care diagnostic test for β-thalassemia. We evaluated the accuracy of Gazelle for the β-Thal screening across 372 subjects in the age range of 4-63 years at Apple Diagnostics lab in Mumbai, India. Additionally, 30 blood samples were prepared to mimic β-Thal intermediate and β-Thal major samples. Gazelle-detected levels of Hb A, Hb F, and Hb A2 demonstrated high levels of correlation with the results reported through laboratory gold standard high-performance liquid chromatography (HPLC), yielding a Pearson correlation coefficient = 0.99. This ability to obtain rapid and accurate results suggests that Gazelle may be suitable for the large-scale screening and diagnosis of β-Thal.
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Affiliation(s)
- Ran An
- Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH 44106, USA
- Department of Biomedical Engineering, University of Houston, Houston, TX 77004, USA
- Department of Biomedical Sciences, University of Houston, Houston, TX 77004, USA
| | | | | | - Sai Nemade
- Plasma Lab, Jalgaon 425001, India (A.M.)
- Apple Diagnostics Lab, Ghatkopar, Mumbai 400077, India
| | - Amrish Mehta
- Plasma Lab, Jalgaon 425001, India (A.M.)
- Apple Diagnostics Lab, Ghatkopar, Mumbai 400077, India
| | - Umut A. Gurkan
- Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH 44106, USA
- Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH 44106, USA
- Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH 44106, USA
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Aly MM, Al-Shoaibi AM, Abduraba Ali S, Al Fattani A, Eldawoody H. How Often Would MRI Change the Thoracolumbar Fracture Classification or Decision-Making Compared to CT Alone? Global Spine J 2024; 14:11-24. [PMID: 35382642 PMCID: PMC10676184 DOI: 10.1177/21925682221089579] [Citation(s) in RCA: 10] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/15/2022] Open
Abstract
STUDY DESIGN retrospective study of consecutive patients. OBJECTIVE to analyze the frequency of change in Thoracolumbar fractures (TLFs) classification or decision-making after MRI compared by CT alone. METHODS A retrospective review of 244 consecutive patients with acute TLFs (T1-L5) presented to a single level 1 trauma center between 2014 and 2021. Three and 4 reviewers independently classified all fractures according to AOSpine and AOSpine injury severity score (TLAOSIS) by CT then MRI, respectively. Posterior ligamentous complex Injury (PLC) was diagnosed on CT and MRI by ≥ 2 positive CT findings and Black stripe discontinuity. RESULTS MRI changed AO classification in 25/244 patients (10.2%, P < .0001) due to an 8.2% upgrade from type A to type B and a 2% downgrade from type B to type A. The addition of MRI changed TL AOSIS among the 3 treatment recommendation groups in 35/244 (19.7%, 95% CI [14.9%-25.2%]. The best predictor of upgrade from type A to type B and downgrade from type B to type A was a single positive CT finding and the presence of only 2 CT signs as opposed to ≥3 signs, respectively (P < .0001 P = .03, respectively). Thoracic fractures showed a significantly higher reclassification rate than thoracolumbar and low lumbar (20% vs 10% and 0%, respectively, P = .07). CONCLUSION using appropriate CT/MRI criteria for PLC injury, MRI changed the AOSpine classification by 10% and TLAOSIS based treatment by 19.7%. The best predictors of fracture reclassification by MRI were the number of positive CT findings and fracture level.
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Affiliation(s)
- Mohamed M. Aly
- Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
- Department of Neurosurgery, Mansoura University, Mansoura, Egypt
| | - Abdulbaset M. Al-Shoaibi
- Department of Diagnostic Radiology, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
| | - Saleh Abduraba Ali
- Department of Diagnostic Radiology, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
| | - Areej Al Fattani
- Department of Biostatistics Epidemiology and Scientific computing, King Faisal Specialist Hospital and Research Hospital, Riyadh, Saudi Arabia
| | - Hany Eldawoody
- Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
- Department of Neurosurgery, Mansoura University, Mansoura, Egypt
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Todsen T, Jakobsen KK, Grønlund MP, Callesen RE, Folke F, Larsen H, Ersbøll AK, Benfield T, Gredal T, Klokker M, Kirkby N, von Buchwald C. COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker-Collected Nasal and Throat Swab Specimens: A Randomized Clinical Trial. JAMA Netw Open 2023; 6:e2344295. [PMID: 38055280 PMCID: PMC10701611 DOI: 10.1001/jamanetworkopen.2023.44295] [Citation(s) in RCA: 12] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/13/2023] [Accepted: 10/11/2023] [Indexed: 12/07/2023] Open
Abstract
Importance Self- or health care worker (HCW)-collected nasal swab specimens are the preferred sampling method to perform rapid antigen testing for COVID-19, but it is debated whether throat specimens can improve test sensitivity. Objective To compare the diagnostic accuracy of self- and HCW-collected nasal vs throat swab specimens for COVID-19 rapid antigen testing. Design, Setting, and Participants This per-protocol multicenter randomized clinical trial was conducted from February 15 through March 25, 2022. The participants, individuals aged 16 years or older requesting a COVID-19 test for diagnostic or screening purposes, had 4 specimens collected for individual testing at 1 of 2 urban COVID-19 outpatient test centers in Copenhagen, Denmark. Interventions Participants were randomized 1:1 to self-collected or HCW-collected nasal and throat swab specimens for rapid antigen testing. Additional HCW-collected nasal and throat swab specimens for reverse transcriptase-polymerase chain reaction (RT-PCR) were used as the reference standard. Main Outcomes and Measures The primary outcome was sensitivity to diagnose COVID-19 of a self- vs HCW-collected nasal and throat specimen for rapid antigen testing compared with RT-PCR. Results Of 2941 participants enrolled, 2674 (90.9%) had complete test results and were included in the final analysis (1535 [57.4%] women; median age, 40 years [IQR, 28-55 years]); 1074 (40.2%) had COVID-19 symptoms, and 827 (30.9%) were positive for SARS-CoV-2 by RT-PCR. Health care worker-collected throat specimens had higher mean sensitivity than HCW-collected nasal specimens for rapid antigen testing (69.4% [95% CI, 65.1%-73.6%] vs 60.0% [95% CI, 55.4%-64.5%]). However, a subgroup analysis of symptomatic participants found that self-collected nasal specimens were more sensitive than self-collected throat specimens for rapid antigen testing (mean sensitivity, 71.5% [95% CI, 65.3%-77.6%] vs 58.0% [95% CI, 51.2%-64.7%]; P < .001). Combining nasal and throat specimens increased sensitivity for HCW- and self-collected specimens by 21.4 and 15.5 percentage points, respectively, compared with a single nasal specimen (both P < .001). Conclusions and Relevance This randomized clinical trial found that a single HCW-collected throat specimen had higher sensitivity for rapid antigen testing for SARS-CoV-2 than a nasal specimen. In contrast, the self-collected nasal specimens had higher sensitivity than throat specimens for symptomatic participants. Adding a throat specimen to the standard practice of collecting a single nasal specimen could improve sensitivity for rapid antigen testing in health care and home-based settings. Trial Registration ClinicalTrials.gov Identifier: NCT05209178.
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Affiliation(s)
- Tobias Todsen
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
- Copenhagen Academy for Medical Education and Simulation, Capital Region, Copenhagen, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Kathrine K. Jakobsen
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Mathias Peter Grønlund
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
| | - Rasmus E. Callesen
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
| | - Fredrik Folke
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
- Copenhagen Emergency Medical Services, University of Copenhagen, Copenhagen, Denmark
- Department of Cardiology, Copenhagen University Hospital, Herlev Gentofte, Denmark
| | - Helene Larsen
- Center for Diagnostics, Department of Health Technology, Technical University of Denmark, Kongens Lyngby, Denmark
| | - Annette Kjær Ersbøll
- Copenhagen Emergency Medical Services, University of Copenhagen, Copenhagen, Denmark
- National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark
| | - Thomas Benfield
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
- Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre, Hvidovre, Denmark
| | - Tobias Gredal
- Copenhagen Emergency Medical Services, University of Copenhagen, Copenhagen, Denmark
| | - Mads Klokker
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Nikolai Kirkby
- Department of Clinical Microbiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
| | - Christian von Buchwald
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
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12
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Garset-Zamani M, Norling R, Hahn CH, Agander TK, von Buchwald C, Todsen T. Transoral Ultrasound in the Outpatient Clinic for the Diagnostic Work-Up of Oropharyngeal Cancer: A Feasibility Study. Cancers (Basel) 2023; 15:5292. [PMID: 37958465 PMCID: PMC10649062 DOI: 10.3390/cancers15215292] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/05/2023] [Revised: 11/01/2023] [Accepted: 11/01/2023] [Indexed: 11/15/2023] Open
Abstract
Magnetic resonance imaging (MRI) is the preferred imaging modality for oropharyngeal cancers (OPCs), but it has difficulties distinguishing between small OPCs and unilateral tonsil hypertrophy. We hypothesized that surgeon-performed transoral ultrasound (US) could be used to accurately detect T-stage OPCs. We performed a single-center prospective diagnostic accuracy study including patients with suspected or biopsy-verified OPCs during outpatient appointments. All patients were offered transoral US and MRI. If transoral US could not be tolerated by the patient, transcervical US was performed. The primary outcome was the diagnostic accuracy of detecting OPCs with US compared to MRI, using histopathology as the reference standard. The secondary outcome was comparing the primary tumor diameters between US and MRI blinded to each other. Out of the 26 patients included in the study, 21 (81%) had OPCs. Transoral US could be performed in 21/21 and 1/5 patients with suspected palatine and lingual tonsil OPCs, respectively. Overall, US diagnostic accuracy was 92%, compared to 81% with MRI (p = 0.37). US and MRI had a high correlation between tumor diameters in the anteroposterior diameter (R = 0.80, p < 0.001), corresponding to the depth axis on US. In conclusion, this small study showed the promise and feasibility of transoral US to improve the initial clinical evaluations of patients with suspected OPCs.
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Affiliation(s)
- Martin Garset-Zamani
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
- Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3, 2200 Copenhagen, Denmark
| | - Rikke Norling
- Department of Radiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
| | - Christoffer Holst Hahn
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
- Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3, 2200 Copenhagen, Denmark
| | - Tina Klitmøller Agander
- Department of Pathology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
| | - Christian von Buchwald
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
- Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3, 2200 Copenhagen, Denmark
| | - Tobias Todsen
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
- Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3, 2200 Copenhagen, Denmark
- Copenhagen Academy for Medical Education and Simulation, The Capital Region of Denmark, 2100 Copenhagen, Denmark
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13
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Lemmens J, Klarenbeek B, Verstegen M, van Workum F, Hannink G, Ubels S, Rosman C. Performance of a consensus-based algorithm for diagnosing anastomotic leak after minimally invasive esophagectomy for esophageal cancer. Dis Esophagus 2023; 36:doad016. [PMID: 36988007 PMCID: PMC10543373 DOI: 10.1093/dote/doad016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2022] [Revised: 02/17/2023] [Indexed: 03/30/2023]
Abstract
Anastomotic leak (AL) is a common and severe complication after esophagectomy. This study aimed to assess the performance of a consensus-based algorithm for diagnosing AL after minimally invasive esophagectomy. This study used data of the ICAN trial, a multicenter randomized clinical trial comparing cervical and intrathoracic anastomosis, in which a predefined diagnostic algorithm was used to guide diagnosing AL. The algorithm identified patients suspected of AL based on clinical signs, blood C-reactive protein (cut-off value 200 mg/L), and/or drain amylase (cut-off value 200 IU/L). Suspicion of AL prompted evaluation with contrast swallow computed tomography and/or endoscopy to confirm AL. Primary outcome measure was algorithm performance in terms of sensitivity, specificity, and positive and negative predictive values (PPV, NPV), respectively. AL was defined according to the definition of the Esophagectomy Complications Consensus Group. 245 patients were included, and 125 (51%) patients were suspected of AL. The algorithm had a sensitivity of 62% (95% confidence interval [CI]: 46-75), a specificity of 97% (95% CI: 89-100), and a PPV and NPV of 94% (95% CI: 79-99) and 77% (95% CI: 66-86), respectively, on initial assessment. Repeated assessment in 19 patients with persisting suspicion of AL despite negative or inconclusive initial assessment had a sensitivity of 100% (95% CI: 77-100). The algorithm showed poor performance because the low sensitivity indicates the inability of the algorithm to confirm AL on initial assessment. Repeated assessment using the algorithm was needed to confirm remaining leaks.
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Affiliation(s)
- Jobbe Lemmens
- Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Bastiaan Klarenbeek
- Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Moniek Verstegen
- Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Frans van Workum
- Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
- Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
| | - Gerjon Hannink
- Department of Operating Rooms, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Sander Ubels
- Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Camiel Rosman
- Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
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14
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Woodward G, Bajre M, Bhattacharyya S, Breen M, Chiocchia V, Dawes H, Dehbi HM, Descamps T, Frangou E, Fazakarley CA, Harris V, Hawkes W, Hewer O, Johnson CL, Krasner S, Laidlaw L, Lau J, Marwick T, Petersen SE, Piotrowska H, Ridgeway G, Ripley DP, Sanderson E, Savage N, Sarwar R, Tetlow L, Thompson B, Thulborn S, Williamson V, Woodward W, Upton R, Leeson P. PROTEUS Study: A Prospective Randomized Controlled Trial Evaluating the Use of Artificial Intelligence in Stress Echocardiography. Am Heart J 2023; 263:123-132. [PMID: 37192698 DOI: 10.1016/j.ahj.2023.05.003] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2022] [Revised: 05/03/2023] [Accepted: 05/04/2023] [Indexed: 05/18/2023]
Abstract
BACKGROUND Stress echocardiography (SE) is one of the most commonly used diagnostic imaging tests for coronary artery disease (CAD) but requires clinicians to visually assess scans to identify patients who may benefit from invasive investigation and treatment. EchoGo Pro provides an automated interpretation of SE based on artificial intelligence (AI) image analysis. In reader studies, use of EchoGo Pro when making clinical decisions improves diagnostic accuracy and confidence. Prospective evaluation in real world practice is now important to understand the impact of EchoGo Pro on the patient pathway and outcome. METHODS PROTEUS is a randomized, multicenter, 2-armed, noninferiority study aiming to recruit 2,500 participants from National Health Service (NHS) hospitals in the UK referred to SE clinics for investigation of suspected CAD. All participants will undergo a stress echocardiogram protocol as per local hospital policy. Participants will be randomized 1:1 to a control group, representing current practice, or an intervention group, in which clinicians will receive an AI image analysis report (EchoGo Pro, Ultromics Ltd, Oxford, UK) to use during image interpretation, indicating the likelihood of severe CAD. The primary outcome will be appropriateness of clinician decision to refer for coronary angiography. Secondary outcomes will assess other health impacts including appropriate use of other clinical management approaches, impact on variability in decision making, patient and clinician qualitative experience and a health economic analysis. DISCUSSION This will be the first study to assess the impact of introducing an AI medical diagnostic aid into the standard care pathway of patients with suspected CAD being investigated with SE. TRIAL REGISTRATION Clinicaltrials.gov registration number NCT05028179, registered on 31 August 2021; ISRCTN: ISRCTN15113915; IRAS ref: 293515; REC ref: 21/NW/0199.
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Affiliation(s)
| | - Mamta Bajre
- Oxford Academic Health Science Network, Magdalen Centre-Whitehead Building, Oxford, UK
| | - Sanjeev Bhattacharyya
- Barts Heart Centre, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London, UK
| | | | - Virginia Chiocchia
- Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
| | - Helen Dawes
- Oxford Clinical Allied Technology and Trial Services Unit, Oxford Brookes University, Oxford, UK
| | - Hakim-Moulay Dehbi
- UCL Comprehensive Clinical Trials Unit, University College London, London, UK
| | | | | | | | - Victoria Harris
- Department of Primary Health Care Sciences, University of Oxford, Oxford, UK
| | | | | | - Casey L Johnson
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK
| | - Samuel Krasner
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK
| | - Lynn Laidlaw
- British Society of Echocardiography. (BSE) Wavelength PPI group member, NIHR and BMJ lay reviewer
| | | | - Tom Marwick
- Baker Heart and Diabetes Institute, Melbourne Victoria, Australia
| | - Steffen E Petersen
- Barts Heart Centre, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London, UK; William Harvey Research Institute, NIHR Barts Biomedical Research Centre, Queen Mary University London, Charterhouse Square, London, UK
| | | | - Ged Ridgeway
- Oxford Brain Diagnostics Ltd, Oxford Centre for Innovation, Oxford, UK
| | - David P Ripley
- School of Medicine, Faculty of Health Sciences and Wellbeing, University of Sunderland, London, UK
| | | | - Natalie Savage
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK
| | | | | | | | | | | | - William Woodward
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK
| | | | - Paul Leeson
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK.
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15
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Boothby-Shoemaker W, Guan L, Jones B, Chaffins M, Kohen L, Pimentel J, Veenstra J, Friedman BJ. Real world validation of an adjunctive gene expression-profiling assay for melanoma diagnosis and correlation with clinical outcomes at an academic center. Hum Pathol 2023; 139:73-79. [PMID: 37423481 DOI: 10.1016/j.humpath.2023.07.002] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/01/2023] [Revised: 07/02/2023] [Accepted: 07/05/2023] [Indexed: 07/11/2023]
Abstract
A commercially available diagnostic gene expression profiling (GEP) assay (MyPath™) reportedly has high sensitivity and specificity in distinguishing nevi from melanoma based on manufacturer-conducted studies. However, data regarding the performance of this GEP assay in routine clinical practice are lacking. The purpose of this study was to better assess the real-world performance of GEP in a large academic practice. Retrospective review of GEP scores were compared with final histomorphologic interpretation on a wide spectrum of melanocytic lesions demonstrating some degree of atypia. In a sample of 369 lesions, the sensitivity (76.1%) and specificity (83.9%) of the GEP test as compared with final dermatopathologist-rendered diagnosis in our dataset was appreciably lower than that reported in the prior manufacturer-conducted validation studies. Limitations of this study were that it was a single-center study, its retrospective nature, nonblinded nature of GEP test result, concordance of only two pathologists, and limited follow-up time.The sensitivity and specificity of a commercially available GEP diagnostic assay for melanoma may be lower in routine clinical practice, where melanocytic lesions typically exhibit some degree of histomorphologic atypia. Reported cost effectiveness of GEP testing is questionable if all ambiguous lesions that undergo such testing are re-excised in clinical practice.
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Affiliation(s)
| | - Linna Guan
- Henry Ford Health, Department of Dermatology, Detroit, MI 48202, USA
| | - Brittani Jones
- Wayne State University School of Medicine, Detroit, MI 48201 USA
| | - Marsha Chaffins
- Henry Ford Health, Department of Dermatology, Detroit, MI 48202, USA
| | - Laurie Kohen
- Henry Ford Health, Department of Dermatology, Detroit, MI 48202, USA
| | - Jason Pimentel
- Henry Ford Health, Department of Pathology and Laboratory Medicine, Detroit, MI 48202, USA
| | - Jesse Veenstra
- Henry Ford Health, Department of Dermatology, Detroit, MI 48202, USA
| | - Ben J Friedman
- Henry Ford Health, Department of Dermatology, Detroit, MI 48202, USA.
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16
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Koop C, Kruus P, Hallik R, Lehemets H, Vettus E, Niin M, Ross P, Kingo K. A country-wide teledermatoscopy service in Estonia shows results comparable to those in experimental settings in management plan development and diagnostic accuracy: A retrospective database study. JAAD Int 2023; 12:81-89. [PMID: 37288150 PMCID: PMC10241971 DOI: 10.1016/j.jdin.2023.02.019] [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: 02/12/2023] [Indexed: 06/09/2023] Open
Abstract
Background Teledermatoscopy accuracy has been examined in experimental settings and is recommended for primary care despite lacking real-world implementation evidence. A teledermatoscopy service has been provided in Estonia since 2013, where lesions are evaluated based on the patient's or general practitioner's suggestion. Objective The management plan and diagnostic accuracy of a real-world store-and-forward teledermatoscopy service for melanoma diagnosis were evaluated. Methods A retrospective study analyzed 4748 cases from 3403 patients using the service between October 16, 2017 and August 30, 2019 by matching country-wide databases. Management plan accuracy was calculated as the percentage of melanoma found that was managed correctly. Diagnostic accuracy parameters were sensitivity, specificity, and positive and negative predictive values. Results Management plan accuracy for melanoma detection was 95.5% (95% CI, 77.2-99.9). Diagnostic accuracy showed a sensitivity of 90.48% (95% CI, 69.62-98.83) and a specificity of 92.57% (95% CI, 91.79-93.31). Limitations Matching the lesions was limited to SNOMED CT location standard precision. Diagnostic accuracy was calculated based on a combination of diagnosis and management plan data. Conclusion Teledermatoscopy for detecting and managing melanoma in real-world clinical practice displays results comparable with those in experimental setting studies.
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Affiliation(s)
| | - Priit Kruus
- Dermtest OÜ, Tallinn, Estonia
- Department of Health Technologies, Tallinn University of Technology, School of Information Technology, Tallinn, Estonia
| | - Riina Hallik
- Department of Health Technologies, Tallinn University of Technology, School of Information Technology, Tallinn, Estonia
| | | | - Elen Vettus
- East Tallinn Central Hospital, Clinic of Internal Medicine, Centre of Oncology, Tallinn, Estonia
| | | | - Peeter Ross
- Department of Health Technologies, Tallinn University of Technology, School of Information Technology, Tallinn, Estonia
- East Tallinn Central Hospital, Tallinn, Estonia
| | - Külli Kingo
- Department of Dermatology and Venerology, Faculty of Medicine, Institute of Clinical Medicine, University of Tartu, Tartu, Estonia
- Tartu University Hospital, Dermatology Clinic, Tartu, Estonia
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Stahlmann K, Reitsma JB, Zapf A. Missing values and inconclusive results in diagnostic studies - A scoping review of methods. Stat Methods Med Res 2023; 32:1842-1855. [PMID: 37559474 PMCID: PMC10540494 DOI: 10.1177/09622802231192954] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/11/2023]
Abstract
Most diagnostic studies exclude missing values and inconclusive results from the analysis or apply simple methods resulting in biased accuracy estimates. This may be due to the lack of availability or awareness of appropriate methods. This scoping review aimed to provide an overview of strategies to handle missing values and inconclusive results in the reference standard or index test in diagnostic accuracy studies. Conducting a systematic literature search in MEDLINE, Cochrane Library, and Web of Science, we could identify many articles proposing methods for addressing missing values in the reference standard. There are also several articles describing methods regarding missing values or inconclusive results in the index test. The latter encompass imputation, frequentist and Bayesian likelihood, model-based, and latent class methods. While methods for missing values in the reference standard are regularly applied in practice, this is not true for methods addressing missing values and inconclusive results in the index test. Our comprehensive overview and description of available methods may raise further awareness of these methods and will enhance their application. Future research is needed to compare the performance of these methods under different conditions to give valid and robust recommendations for their usage in various diagnostic accuracy research scenarios.
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Affiliation(s)
- Katharina Stahlmann
- Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany
| | - Johannes B Reitsma
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands
| | - Antonia Zapf
- Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany
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Zu W, Huang X, Xu T, Du L, Wang Y, Wang L, Nie W. Machine learning in predicting outcomes for stroke patients following rehabilitation treatment: A systematic review. PLoS One 2023; 18:e0287308. [PMID: 37379289 DOI: 10.1371/journal.pone.0287308] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/31/2022] [Accepted: 06/03/2023] [Indexed: 06/30/2023] Open
Abstract
OBJECTIVE This review aimed to summarize the use of machine learning for predicting the potential benefits of stroke rehabilitation treatments, to evaluate the risk of bias of predictive models, and to provide recommendations for future models. MATERIALS AND METHODS This systematic review was conducted in accordance with the PRISMA statement and the CHARMS checklist. The PubMed, Embase, Cochrane Library, Scopus, and CNKI databases were searched up to April 08, 2023. The PROBAST tool was used to assess the risk of bias of the included models. RESULTS Ten studies within 32 models met our inclusion criteria. The optimal AUC value of the included models ranged from 0.63 to 0.91, and the optimal R2 value ranged from 0.64 to 0.91. All of the included models were rated as having a high or unclear risk of bias, and most of them were downgraded due to inappropriate data sources or analysis processes. DISCUSSION AND CONCLUSION There remains much room for improvement in future modeling studies, such as high-quality data sources and model analysis. Reliable predictive models should be developed to improve the efficacy of rehabilitation treatment by clinicians.
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Affiliation(s)
- Wanting Zu
- School of Nursing, Jilin University, Changchun, China
| | - Xuemiao Huang
- School of Nursing, Jilin University, Changchun, China
| | - Tianxin Xu
- School of Nursing, Jilin University, Changchun, China
| | - Lin Du
- School of Nursing, Jilin University, Changchun, China
| | - Yiming Wang
- School of Nursing, Jilin University, Changchun, China
| | - Lisheng Wang
- School of Nursing, Jilin University, Changchun, China
| | - Wenbo Nie
- School of Nursing, Jilin University, Changchun, China
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Kim JK, Lee DW, Geum S, Yoo JH, Park H. Ultrasonographic Localization of Parotid Gland Tumor Relative to the Facial Nerve Using Stensen's Duct Criterion. J Oral Maxillofac Surg 2023:S0278-2391(23)00474-3. [PMID: 37301226 DOI: 10.1016/j.joms.2023.05.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/03/2023] [Revised: 05/24/2023] [Accepted: 05/25/2023] [Indexed: 06/12/2023]
Abstract
PURPOSE During the preoperative evaluation of parotid gland tumors, 1 of the main concerns is to determine the location of the tumors in relation to the facial nerve. This study aims to assess the value of ultrasound for determination of the location of parotid gland tumors in relation to the facial nerve using Stensen's duct. METHODS This is a retrospective cross-sectional study at a single institute. The subjects who underwent preoperative ultrasound and parotidectomy for parotid gland tumors were included. The subjects with incomplete operative records or no reference standard for the location of parotid gland tumor were excluded. The primary predictor was ultrasound tumor location, which was defined as the location of parotid gland tumors determined by preoperative ultrasound as to whether the tumors were superficial or deep to the facial nerve. The operative records were used as the reference standard for the location of parotid gland tumors. The primary outcome was diagnostic performances of preoperative ultrasound in predicting the location of parotid gland tumors, which were calculated by comparing ultrasound tumor location to the reference standard. Covariates were sex, age, type of surgery, tumor size, and tumor histology. Data analysis involved descriptive and analytic statistics; P < .05 was considered significant. RESULTS One hundred and two of 140 eligible subjects met inclusion and exclusion criteria. There were 50 male and 52 female, with a mean age of 53.3 years. Ultrasound tumor location was classified as deep in 29 subjects, superficial in 50, and indeterminate in 23. The reference standard was deep in 32 subjects and superficial in 70. Indeterminate ultrasound tumor location results were grouped as either deep or superficial to make every possible cross table in which ultrasound tumor location results were presented as a dichotomy. The mean sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the ultrasound to predict the deep location of parotid tumors were 87.5, 82.1, 70.2, 93.6, and 83.8%, respectively. CONCLUSIONS Stensen's duct on ultrasound can be a useful criterion to determine the location of parotid gland tumor relative to the facial nerve.
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Affiliation(s)
- Jeong Kyu Kim
- Professor, Department of Otolaryngology-Head and Neck Surgery, Daegu Catholic University School of Medicine, Daegu, Republic of Korea.
| | - Dong Won Lee
- Professor, Department of Otolaryngology-Head and Neck Surgery, Daegu Catholic University School of Medicine, Daegu, Republic of Korea
| | - Sangyen Geum
- Resident, Department of Otolaryngology-Head and Neck Surgery, Daegu Catholic University School of Medicine, Daegu, Republic of Korea
| | - Jae Ho Yoo
- Resident, Department of Otolaryngology-Head and Neck Surgery, Daegu Catholic University School of Medicine, Daegu, Republic of Korea
| | - Heejun Park
- Resident, Department of Otolaryngology-Head and Neck Surgery, Daegu Catholic University School of Medicine, Daegu, Republic of Korea
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Domen J, Verbakel JYJ, Adriaenssens N, Scholtes B, Peeters B, Bruyndonckx R, De Sutter A, Heytens S, Van den Bruel A, Desombere I, Van Damme P, Goossens H, Buret L, Duysburgh E, Coenen S. Validation of a rapid SARS-CoV-2 antibody test in general practice. BMJ Open 2023; 13:e069997. [PMID: 37130685 PMCID: PMC10163333 DOI: 10.1136/bmjopen-2022-069997] [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] [Indexed: 05/04/2023] Open
Abstract
OBJECTIVES To validate a rapid serological test (RST) for SARS-CoV-2 antibodies used in seroprevalence studies in healthcare providers, including primary healthcare providers (PHCPs) in Belgium. DESIGN A phase III validation study of the RST (OrientGene) within a prospective cohort study. SETTING Primary care in Belgium. PARTICIPANTS Any general practitioner (GP) working in primary care in Belgium and any other PHCP from the same GP practice who physically manages patients were eligible in the seroprevalence study. For the validation study, all participants who tested positive (376) on the RST at the first testing timepoint (T1) and a random sample of those who tested negative (790) and unclear (24) were included. INTERVENTION At T2, 4 weeks later, PHCPs performed the RST with fingerprick blood (index test) immediately after providing a serum sample to be analysed for the presence of SARS-CoV-2 immunoglobulin G antibodies using a two-out-of-three assay (reference test). PRIMARY AND SECONDARY OUTCOME MEASURES The RST accuracy was estimated using inverse probability weighting to correct for missing reference test data, and considering unclear RST results as negative for the sensitivity and positive for the specificity. Using these conservative estimates, the true seroprevalence was estimated both for T2 and RST-based prevalence values found in a cohort study with PHCPs in Belgium. RESULTS 1073 paired tests (403 positive on the reference test) were included. A sensitivity of 73% (a specificity of 92%) was found considering unclear RST results as negative (positive). For an RST-based prevalence at T1 (13.9), T2 (24.9) and T7 (70.21), the true prevalence was estimated to be 9.1%, 25.9% and 95.7%, respectively. CONCLUSION The RST sensitivity (73%) and specificity (92%) make an RST-based seroprevalence below (above) 23% overestimate (underestimate) the true seroprevalence. TRIAL REGISTRATION NUMBER NCT04779424.
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Affiliation(s)
- Julie Domen
- Department of Family Medicine and Population Health (FAMPOP), Centre for General Practice, University of Antwerp, Antwerpen, Belgium
| | - Jan Yvan Jos Verbakel
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Department of Public Health and Primary Care, EPI-Centre, KU Leuven, Leuven, Belgium
| | - Niels Adriaenssens
- Department of Family Medicine and Population Health (FAMPOP), Centre for General Practice, University of Antwerp, Antwerpen, Belgium
| | - Beatrice Scholtes
- General Practice Department-Primary Care and Health Research Unit, Liege University, Liege, Belgium
| | - Bart Peeters
- Department of Laboratory Medicine, University Hospital Antwerp, Edegem, Belgium
| | - Robin Bruyndonckx
- Department of Family Medicine and Population Health (FAMPOP), Centre for General Practice, University of Antwerp, Antwerpen, Belgium
- Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), Data Science Institute, Hasselt University, Hasselt, Belgium
- Epidemiology & Pharmavigilance, P95, Leuven, Belgium
| | - An De Sutter
- Department of Public Health and Primary Care, University of Ghent, Gent, Belgium
| | - Stefan Heytens
- Department of Public Health and Primary Care, University of Ghent, Gent, Belgium
| | - Ann Van den Bruel
- Department of Public Health and Primary Care, EPI-Centre, KU Leuven, Leuven, Belgium
| | - Isabelle Desombere
- Department of Infectious Diseases in Humans, Sciensano, Brussels, Belgium
| | - Pierre Van Damme
- Vaccine & Infectious Disease Institute, Centre for the Evaluation of Vaccination, University of Antwerp Faculty of Medicine and Health Sciences, Antwerpen (Wilrijk, Belgium
| | - Herman Goossens
- Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerpen, Belgium
| | - Laetitia Buret
- General Practice Department-Primary Care and Health Research Unit, Liege University, Liege, Belgium
| | - Els Duysburgh
- Department of Epidemiology and Public Health, Sciensano, Brussels, Belgium
| | - Samuel Coenen
- Department of Family Medicine and Population Health (FAMPOP), Centre for General Practice, University of Antwerp, Antwerpen, Belgium
- Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerpen, Belgium
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21
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Hughes DM, Bird SM, Cheyne CP, Ashton M, Campbell MC, García-Fiñana M, Buchan I. Rapid antigen testing in COVID-19 management for school-aged children: an observational study in Cheshire and Merseyside, UK. J Public Health (Oxf) 2023; 45:e38-e47. [PMID: 35137216 PMCID: PMC8903429 DOI: 10.1093/pubmed/fdac003] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2021] [Revised: 12/22/2021] [Accepted: 01/02/2022] [Indexed: 11/15/2022] Open
Abstract
BACKGROUND Twice weekly lateral flow tests (LFTs) for secondary school children was UK Government policy from 8 March 2021. We evaluate use of LFTs (both supervised at test centres, and home test kits) in school-aged children in Cheshire and Merseyside. METHODS We report (i) number of LFT positives (ii) proportion of LFT positive with confirmatory reverse transcription polymerase chain reaction (PCR) test within 2 days, and (iii) agreement between LFT-positive and confirmatory PCR, and dependence of (i-iii) on COVID-19 prevalence. FINDINGS 1 248 468 LFTs were taken by 211 255 12-18 years old, and 163 914 by 52 116 5-11 years old between 6 November 2020 and 31 July 2021. Five thousand three hundred and fourteen (2.5%) 12-18 years old and 1996 (3.8%) 5-11 years old returned LFT positives, with 3829 (72.1%) and 1535 (76.9%) confirmatory PCRs, and 3357 (87.7%) and 1383 (90.1%) confirmatory PCR-positives, respectively.Monthly proportions of LFT positive with PCR negative varied between 4.7% and 35.3% in 12-18 years old (corresponding proportion of all tests positive: 9.7% and 0.3%).Deprivation and non-White ethnicity were associated with reduced uptake of confirmatory PCR. INTERPRETATION Substantial inequalities in confirmatory testing need more attention to avoid further disadvantage through education loss. When prevalence is low additional measures, including confirmatory testing, are needed. Local Directors of Public Health taking more control over schools testing may be needed. FUNDING DHSC, MRC, NIHR, EPSRC.
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Affiliation(s)
- David M Hughes
- Department of Health Data Science, University of Liverpool, Liverpool, UK
| | - Sheila M Bird
- MRC Biostatistics Unit, Cambridge, UK.,Edinburgh University's College of Medicine and Veterinary Medicine, Edinburgh, UK
| | | | - Matthew Ashton
- Department of Public Health, Liverpool City Council, Liverpool, UK
| | | | | | - Iain Buchan
- Institute of Population Health Sciences, University of Liverpool, Liverpool, UK
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22
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Pharo HD, Jeanmougin M, Ager-Wick E, Vedeld HM, Sørbø AK, Dahl C, Larsen LK, Honne H, Brandt-Winge S, Five MB, Monteiro-Reis S, Henrique R, Jeronimo C, Steven K, Wahlqvist R, Guldberg P, Lind GE. BladMetrix: a novel urine DNA methylation test with high accuracy for detection of bladder cancer in hematuria patients. Clin Epigenetics 2022; 14:115. [PMID: 36115961 PMCID: PMC9482155 DOI: 10.1186/s13148-022-01335-2] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/06/2022] [Accepted: 09/11/2022] [Indexed: 11/10/2022] Open
Abstract
Background Cystoscopy is the gold standard for bladder cancer detection, but is costly, invasive and has imperfect diagnostic accuracy. We aimed to identify novel and accurate DNA methylation biomarkers for non-invasive detection of bladder cancer in urine, with the potential to reduce the number of cystoscopies among hematuria patients. Results Biomarker candidates (n = 32) were identified from methylome sequencing of urological cancer cell lines (n = 16) and subjected to targeted methylation analysis in tissue samples (n = 60). The most promising biomarkers (n = 8) were combined into a panel named BladMetrix. The performance of BladMetrix in urine was assessed in a discovery series (n = 112), consisting of bladder cancer patients, patients with other urological cancers and healthy individuals, resulting in 95.7% sensitivity and 94.7% specificity. BladMetrix was furthermore evaluated in an independent prospective and blinded series of urine from patients with gross hematuria (n = 273), achieving 92.1% sensitivity, 93.3% specificity and a negative predictive value of 98.1%, with the potential to reduce the number of cystoscopies by 56.4%. Conclusions We here present BladMetrix, a novel DNA methylation urine test for non-invasive detection of bladder cancer, with high accuracy across tumor grades and stages, and the ability to spare a significant number of cystoscopies among patients with gross hematuria. Supplementary Information The online version contains supplementary material available at 10.1186/s13148-022-01335-2.
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23
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Multispectral imaging for MicroChip electrophoresis enables point-of-care newborn hemoglobin variant screening. Heliyon 2022; 8:e11778. [DOI: 10.1016/j.heliyon.2022.e11778] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2022] [Revised: 08/30/2022] [Accepted: 11/14/2022] [Indexed: 11/30/2022] Open
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24
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Lee J, Mulder F, Leeflang M, Wolff R, Whiting P, Bossuyt PM. QUAPAS: An Adaptation of the QUADAS-2 Tool to Assess Prognostic Accuracy Studies. Ann Intern Med 2022; 175:1010-1018. [PMID: 35696685 DOI: 10.7326/m22-0276] [Citation(s) in RCA: 29] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
Whereas diagnostic tests help detect the cause of signs and symptoms, prognostic tests assist in evaluating the probable course of the disease and future outcome. Studies to evaluate prognostic tests are longitudinal, which introduces sources of bias different from those for diagnostic accuracy studies. At present, systematic reviews of prognostic tests often use the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) tool to assess risk of bias and applicability of included studies because no equivalent instrument exists for prognostic accuracy studies. QUAPAS (Quality Assessment of Prognostic Accuracy Studies) is an adaptation of QUADAS-2 for prognostic accuracy studies. Questions likely to identify bias were evaluated in parallel and collated from QUIPS (Quality in Prognosis Studies) and PROBAST (Prediction Model Risk of Bias Assessment Tool) and paired to the corresponding question (or domain) in QUADAS-2. A steering group conducted and reviewed 3 rounds of modifications before arriving at the final set of domains and signaling questions. QUAPAS follows the same steps as QUADAS-2: Specify the review question, tailor the tool, draw a flow diagram, judge risk of bias, and identify applicability concerns. Risk of bias is judged across the following 5 domains: participants, index test, outcome, flow and timing, and analysis. Signaling questions assist the final judgment for each domain. Applicability concerns are assessed for the first 4 domains. The authors used QUAPAS in parallel with QUADAS-2 and QUIPS in a systematic review of prognostic accuracy studies. QUAPAS improved the assessment of the flow and timing domain and flagged a study at risk of bias in the new analysis domain. Judgment of risk of bias in the analysis domain was challenging because of sparse reporting of statistical methods.
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Affiliation(s)
- Jenny Lee
- Department of Epidemiology and Data Science, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.L., M.L., P.M.B.)
| | - Frits Mulder
- Department of Vascular Medicine, Cardiovascular Sciences, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands (F.M.)
| | - Mariska Leeflang
- Department of Epidemiology and Data Science, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.L., M.L., P.M.B.)
| | - Robert Wolff
- Kleijnen Systematic Reviews, Escrick, United Kingdom (R.W.)
| | - Penny Whiting
- Bristol Medical School, University of Bristol, Bristol, United Kingdom (P.W.)
| | - Patrick M Bossuyt
- Department of Epidemiology and Data Science, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.L., M.L., P.M.B.)
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25
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Tros R, Rosielle K, Koks C, Mijatovic V, Bongers MY, Mol BWJ, Wang R. Visual tubal patency tests for tubal occlusion and hydrosalpinx. Hippokratia 2022. [DOI: 10.1002/14651858.cd014968] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Affiliation(s)
- Rachel Tros
- Department of Obstetrics and Gynaecology; Amsterdam UMC, VU Universiteit Amsterdam, De Boelelaan 1117; Amsterdam Netherlands
| | - Kimmy Rosielle
- Department of Obstetrics and Gynaecology; Amsterdam UMC, VU Universiteit Amsterdam, De Boelelaan 1117; Amsterdam Netherlands
| | - Carolien Koks
- Department of Reproductive Medicine; Máxima MC; Eindhoven Netherlands
| | - Velja Mijatovic
- Academic Endometriosis Center, Department of Reproductive Medicine; Amsterdam UMC; Amsterdam Netherlands
| | - Marlies Y Bongers
- Department of Obstetrics and Gynaecology; Máxima Medisch Centrum; Veldhoven Netherlands
| | - Ben Willem J Mol
- Department of Obstetrics and Gynaecology; Monash University; Clayton Australia
| | - Rui Wang
- Department of Obstetrics and Gynaecology; Monash University; Clayton Australia
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26
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Gu S, Zhao Q, Yao J, Zhang L, Xu L, Chen W, Gu Y, Xu J. Diagnostic Ability of Ultrasonography in Brachial Plexus Root Injury at Different Stages Post-trauma. ULTRASOUND IN MEDICINE & BIOLOGY 2022; 48:1122-1130. [PMID: 35331579 DOI: 10.1016/j.ultrasmedbio.2022.02.013] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/26/2021] [Revised: 01/30/2022] [Accepted: 02/10/2022] [Indexed: 06/14/2023]
Abstract
Brachial plexus (BP) root injury often results in disability of the upper extremities. Improvements in high-frequency ultrasonography have enabled the visualization of BP nerve roots. This study was aimed at quantifying the diagnostic accuracy of ultrasonography in BP root injury at different stages post-trauma. A consecutive series of 170 patients with BP root injury between 2015 and 2019 were studied retrospectively and divided into three groups on the basis of time between injury and ultrasound examination (≤1 mo, 1-3 mo, >3 mo). Diagnosis of complete BP root injury under ultrasound was determined using a pre-defined criterion, including pseudomeningocele, retraction and rupture. Diagnostic accuracy was calculated based on surgical findings and intra-operative electrophysiological tests. Rates of detection of the cervical (C5-C8) and thoracic (T1) nerve roots under ultrasound were 99.4%, 99.4%, 99.4%, 95.9% and 79.4%, respectively. The sensitivity for complete BP root injury was 0.74, and the specificity was 0.91. No significant differences in sensitivity or specificity were observed across time stages. Ultrasound exhibited substantial consistency with surgical findings (κ = 0.70) for complete BP root injury at any stage post-injury. Ultrasound can be an optional method of diagnosis of complete BP root injury at an early stage post-injury.
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Affiliation(s)
- Shihui Gu
- Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Hand Reconstruction (Fudan University), Shanghai, China; Shanghai Key Laboratory of Peripheral Nerve and Microsurgery, Shanghai, China
| | - Qian Zhao
- Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Hand Reconstruction (Fudan University), Shanghai, China; Shanghai Key Laboratory of Peripheral Nerve and Microsurgery, Shanghai, China
| | - Jing Yao
- Department of Ultrasound, Huashan Hospital, Fudan University, Shanghai, China
| | - Li Zhang
- Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Hand Reconstruction (Fudan University), Shanghai, China; Shanghai Key Laboratory of Peripheral Nerve and Microsurgery, Shanghai, China
| | - Lei Xu
- Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Hand Reconstruction (Fudan University), Shanghai, China; Shanghai Key Laboratory of Peripheral Nerve and Microsurgery, Shanghai, China
| | - Weiming Chen
- Department of Ultrasound, Huashan Hospital, Fudan University, Shanghai, China
| | - Yudong Gu
- Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Hand Reconstruction (Fudan University), Shanghai, China; Shanghai Key Laboratory of Peripheral Nerve and Microsurgery, Shanghai, China
| | - Jianguang Xu
- Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Hand Reconstruction (Fudan University), Shanghai, China; Shanghai Key Laboratory of Peripheral Nerve and Microsurgery, Shanghai, China.
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27
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Pillay S, Steingart KR, Davies GR, Chaplin M, De Vos M, Schumacher SG, Warren R, Theron G. Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin. Cochrane Database Syst Rev 2022; 5:CD014841. [PMID: 35583175 PMCID: PMC9115865 DOI: 10.1002/14651858.cd014841.pub2] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
Abstract
BACKGROUND The World Health Organization (WHO) End TB Strategy stresses universal access to drug susceptibility testing (DST). DST determines whether Mycobacterium tuberculosis bacteria are susceptible or resistant to drugs. Xpert MTB/XDR is a rapid nucleic acid amplification test for detection of tuberculosis and drug resistance in one test suitable for use in peripheral and intermediate level laboratories. In specimens where tuberculosis is detected by Xpert MTB/XDR, Xpert MTB/XDR can also detect resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin. OBJECTIVES To assess the diagnostic accuracy of Xpert MTB/XDR for pulmonary tuberculosis in people with presumptive pulmonary tuberculosis (having signs and symptoms suggestive of tuberculosis, including cough, fever, weight loss, night sweats). To assess the diagnostic accuracy of Xpert MTB/XDR for resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin in people with tuberculosis detected by Xpert MTB/XDR, irrespective of rifampicin resistance (whether or not rifampicin resistance status was known) and with known rifampicin resistance. SEARCH METHODS We searched multiple databases to 23 September 2021. We limited searches to 2015 onwards as Xpert MTB/XDR was launched in 2020. SELECTION CRITERIA Diagnostic accuracy studies using sputum in adults with presumptive or confirmed pulmonary tuberculosis. Reference standards were culture (pulmonary tuberculosis detection); phenotypic DST (pDST), genotypic DST (gDST),composite (pDST and gDST) (drug resistance detection). DATA COLLECTION AND ANALYSIS Two review authors independently reviewed reports for eligibility and extracted data using a standardized form. For multicentre studies, we anticipated variability in the type and frequency of mutations associated with resistance to a given drug at the different centres and considered each centre as an independent study cohort for quality assessment and analysis. We assessed methodological quality with QUADAS-2, judging risk of bias separately for each target condition and reference standard. For pulmonary tuberculosis detection, owing to heterogeneity in participant characteristics and observed specificity estimates, we reported a range of sensitivity and specificity estimates and did not perform a meta-analysis. For drug resistance detection, we performed meta-analyses by reference standard using bivariate random-effects models. Using GRADE, we assessed certainty of evidence of Xpert MTB/XDR accuracy for detection of resistance to isoniazid and fluoroquinolones in people irrespective of rifampicin resistance and to ethionamide and amikacin in people with known rifampicin resistance, reflecting real-world situations. We used pDST, except for ethionamide resistance where we considered gDST a better reference standard. MAIN RESULTS We included two multicentre studies from high multidrug-resistant/rifampicin-resistant tuberculosis burden countries, reporting on six independent study cohorts, involving 1228 participants for pulmonary tuberculosis detection and 1141 participants for drug resistance detection. The proportion of participants with rifampicin resistance in the two studies was 47.9% and 80.9%. For tuberculosis detection, we judged high risk of bias for patient selection owing to selective recruitment. For ethionamide resistance detection, we judged high risk of bias for the reference standard, both pDST and gDST, though we considered gDST a better reference standard. Pulmonary tuberculosis detection - Xpert MTB/XDR sensitivity range, 98.3% (96.1 to 99.5) to 98.9% (96.2 to 99.9) and specificity range, 22.5% (14.3 to 32.6) to 100.0% (86.3 to 100.0); median prevalence of pulmonary tuberculosis 91.3%, (interquartile range, 89.3% to 91.8%), (2 studies; 1 study reported on 2 cohorts, 1228 participants; very low-certainty evidence, sensitivity and specificity). Drug resistance detection People irrespective of rifampicin resistance - Isoniazid resistance: Xpert MTB/XDR summary sensitivity and specificity (95% confidence interval (CI)) were 94.2% (87.5 to 97.4) and 98.5% (92.6 to 99.7) against pDST, (6 cohorts, 1083 participants, moderate-certainty evidence, sensitivity and specificity). - Fluoroquinolone resistance: Xpert MTB/XDR summary sensitivity and specificity were 93.2% (88.1 to 96.2) and 98.0% (90.8 to 99.6) against pDST, (6 cohorts, 1021 participants; high-certainty evidence, sensitivity; moderate-certainty evidence, specificity). People with known rifampicin resistance - Ethionamide resistance: Xpert MTB/XDR summary sensitivity and specificity were 98.0% (74.2 to 99.9) and 99.7% (83.5 to 100.0) against gDST, (4 cohorts, 434 participants; very low-certainty evidence, sensitivity and specificity). - Amikacin resistance: Xpert MTB/XDR summary sensitivity and specificity were 86.1% (75.0 to 92.7) and 98.9% (93.0 to 99.8) against pDST, (4 cohorts, 490 participants; low-certainty evidence, sensitivity; high-certainty evidence, specificity). Of 1000 people with pulmonary tuberculosis, detected as tuberculosis by Xpert MTB/XDR: - where 50 have isoniazid resistance, 61 would have an Xpert MTB/XDR result indicating isoniazid resistance: of these, 14/61 (23%) would not have isoniazid resistance (FP); 939 (of 1000 people) would have a result indicating the absence of isoniazid resistance: of these, 3/939 (0%) would have isoniazid resistance (FN). - where 50 have fluoroquinolone resistance, 66 would have an Xpert MTB/XDR result indicating fluoroquinolone resistance: of these, 19/66 (29%) would not have fluoroquinolone resistance (FP); 934 would have a result indicating the absence of fluoroquinolone resistance: of these, 3/934 (0%) would have fluoroquinolone resistance (FN). - where 300 have ethionamide resistance, 296 would have an Xpert MTB/XDR result indicating ethionamide resistance: of these, 2/296 (1%) would not have ethionamide resistance (FP); 704 would have a result indicating the absence of ethionamide resistance: of these, 6/704 (1%) would have ethionamide resistance (FN). - where 135 have amikacin resistance, 126 would have an Xpert MTB/XDR result indicating amikacin resistance: of these, 10/126 (8%) would not have amikacin resistance (FP); 874 would have a result indicating the absence of amikacin resistance: of these, 19/874 (2%) would have amikacin resistance (FN). AUTHORS' CONCLUSIONS Review findings suggest that, in people determined by Xpert MTB/XDR to be tuberculosis-positive, Xpert MTB/XDR provides accurate results for detection of isoniazid and fluoroquinolone resistance and can assist with selection of an optimised treatment regimen. Given that Xpert MTB/XDR targets a limited number of resistance variants in specific genes, the test may perform differently in different settings. Findings in this review should be interpreted with caution. Sensitivity for detection of ethionamide resistance was based only on Xpert MTB/XDR detection of mutations in the inhA promoter region, a known limitation. High risk of bias limits our confidence in Xpert MTB/XDR accuracy for pulmonary tuberculosis. Xpert MTB/XDR's impact will depend on its ability to detect tuberculosis (required for DST), prevalence of resistance to a given drug, health care infrastructure, and access to other tests.
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Affiliation(s)
- Samantha Pillay
- DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research; South African Medical Research Council Centre for Tuberculosis Research; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
| | - Karen R Steingart
- Honorary Research Fellow, Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK
| | - Geraint R Davies
- Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK
| | - Marty Chaplin
- Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK
| | | | | | - Rob Warren
- DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research; South African Medical Research Council Centre for Tuberculosis Research; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
| | - Grant Theron
- DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research; South African Medical Research Council Centre for Tuberculosis Research; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
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28
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Biedermann A. The strange persistence of (source) "identification" claims in forensic literature through descriptivism, diagnosticism and machinism. Forensic Sci Int Synerg 2022; 4:100222. [PMID: 35257092 PMCID: PMC8897692 DOI: 10.1016/j.fsisyn.2022.100222] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2021] [Revised: 01/25/2022] [Accepted: 02/10/2022] [Indexed: 12/27/2022]
Abstract
Many forensic scientists consider that identification (individualisation) - in the sense of statements of the kind "the questioned item and the known item come from the same source" - is a concept that is central to their discipline. This is so despite decade-long, fundamental critiques levelled by both practitioners and academics against the conceptual and practical feasibility of forensic identification. Oddly, there is a constant stream of publications in (peer-reviewed) forensic science journals that treat forensic identification axiomatically as a valid object of study, sidestepping the fundamental critiques. This paper reviews and discusses three exemplary strands of publications that exemplify this persistent trend. These strands are called descriptivism, diagnosticism and machinism. The latter term refers to methods borrowed from the now increasingly popular approaches used in the field of machine learning. In turn, descriptivism and diagnosticism refer to general design aspects of mainstream research methods, illustrated here through a critical review of two recent papers on, respectively, forensic odontology and a framework for interpreting fingerprint evidence. The critique of the use of 'identification' in these strands of publication includes, but goes beyond, semantic details and the reiteration of long-known shortcomings of obsolete technical language such as 'match' and 'matching'. Specifically, this paper exposes deeper problems such as the subtle and argumentatively unfounded carrying-over of source conclusions to ultimate issues and the use probability concepts for questions that require more than the mere quantification of uncertainty. This paper submits that in order to foster trust in an era of continually expanding publishing activities, it should be a vital interest to forensic science journals to better examine what identification-related research can and cannot legitimately purport to achieve.
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Affiliation(s)
- Alex Biedermann
- University of Lausanne, School of Criminal Justice, 1015 Lausanne-Dorigny, Switzerland
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29
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Statistical methods for evaluating the fine needle aspiration cytology procedure in breast cancer diagnosis. BMC Med Res Methodol 2022; 22:40. [PMID: 35125097 PMCID: PMC8818244 DOI: 10.1186/s12874-022-01506-y] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/09/2021] [Accepted: 01/10/2022] [Indexed: 01/24/2023] Open
Abstract
Background Statistical issues present while evaluating a diagnostic procedure for breast cancer are non rare but often ignored, leading to biased results. We aimed to evaluate the diagnostic accuracy of the fine needle aspiration cytology(FNAC), a minimally invasive and rapid technique potentially used as a rule-in or rule-out test, handling its statistical issues: suspect test results and verification bias. Methods We applied different statistical methods to handle suspect results by defining conditional estimates. When considering a partial verification bias, Begg and Greenes method and multivariate imputation by chained equations were applied, however, and a Bayesian approach with respect to each gold standard was used when considering a differential verification bias. At last, we extended the Begg and Greenes method to be applied conditionally on the suspect results. Results The specificity of the FNAC test above 94%, was always higher than its sensitivity regardless of the proposed method. All positive likelihood ratios were higher than 10, with variations among methods. The positive and negative yields were high, defining precise discriminating properties of the test. Conclusion The FNAC test is more likely to be used as a rule-in test for diagnosing breast cancer. Our results contributed in advancing our knowledge regarding the performance of FNAC test and the methods to be applied for its evaluation. Supplementary Information The online version contains supplementary material available at (10.1186/s12874-022-01506-y).
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Melville AR, Donaldson K, Dale J, Ciechomska A. Validation of the Southend giant cell arteritis probability score in a Scottish single-centre fast-track pathway. Rheumatol Adv Pract 2021; 6:rkab102. [PMID: 35059557 PMCID: PMC8765789 DOI: 10.1093/rap/rkab102] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/07/2021] [Accepted: 11/30/2021] [Indexed: 11/12/2022] Open
Abstract
OBJECTIVE The aim was to provide external validation of the Southend GCA probability score (GCAPS) in patients attending a GCA fast-track pathway (GCA FTP) in NHS Lanarkshire. METHODS Consecutive GCA FTP patients between November 2018 and December 2020 underwent GCAPS assessment as part of routine care. GCA diagnoses were supported by US of the cranial and axillary arteries (USS), with or without temporal artery biopsy (TAB), and confirmed at 6 months. Percentages of patients with GCA according to GCAPS risk group, performance of total GCAPS in distinguishing GCA/non-GCA final diagnoses, and test characteristics using different GCAPS binary cut-offs were assessed. Associations between individual GCAPS components and GCA and the value of USS and TAB in the diagnostic process were also explored. RESULTS Forty-four of 129 patients were diagnosed with GCA, including 0 of 41 GCAPS low-risk patients (GCAPS <9), 3 of 40 medium-risk patients (GCAPS 9-12) and 41 of 48 high-risk patients (GCAPS >12). Overall performance of GCAPS in distinguishing GCA/non-GCA was excellent [area under the receiver operating characteristic curve, 0.976 (95% CI 0.954, 0.999)]. GCAPS cut-off ≥10 had 100.0% sensitivity and 67.1% specificity for GCA. GCAPS cut-off ≥13 had the highest accuracy (91.5%), with 93.2% sensitivity and 90.6% specificity. Several individual GCAPS components were associated with GCA. Sensitivity of USS increased by ascending GCAPS risk group (nil, 33.3% and 90.2%, respectively). TAB was diagnostically useful in cases where USS was inconclusive. CONCLUSION This is the first published study to describe application of GCAPS outside the specialist centre where it was developed. Performance of GCAPS as a risk stratification tool was excellent. GCAPS might have additional value for screening GCA FTP referrals and guiding empirical glucocorticoid treatment.
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Affiliation(s)
- Andrew R Melville
- Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow
| | - Karen Donaldson
- Rheumatology Department, University Hospital Wishaw, NHS Lanarkshire
| | - James Dale
- Rheumatology Department, University Hospital Wishaw, NHS Lanarkshire
| | - Anna Ciechomska
- Rheumatology Department, University Hospital Wishaw, NHS Lanarkshire
- School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK
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Upton R, Mumith A, Beqiri A, Parker A, Hawkes W, Gao S, Porumb M, Sarwar R, Marques P, Markham D, Kenworthy J, O'Driscoll JM, Hassanali N, Groves K, Dockerill C, Woodward W, Alsharqi M, McCourt A, Wilkes EH, Heitner SB, Yadava M, Stojanovski D, Lamata P, Woodward G, Leeson P. Automated Echocardiographic Detection of Severe Coronary Artery Disease Using Artificial Intelligence. JACC Cardiovasc Imaging 2021; 15:715-727. [PMID: 34922865 DOI: 10.1016/j.jcmg.2021.10.013] [Citation(s) in RCA: 53] [Impact Index Per Article: 13.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/20/2021] [Revised: 10/01/2021] [Accepted: 10/21/2021] [Indexed: 01/27/2023]
Abstract
OBJECTIVES The purpose of this study was to establish whether an artificially intelligent (AI) system can be developed to automate stress echocardiography analysis and support clinician interpretation. BACKGROUND Coronary artery disease is the leading global cause of mortality and morbidity and stress echocardiography remains one of the most commonly used diagnostic imaging tests. METHODS An automated image processing pipeline was developed to extract novel geometric and kinematic features from stress echocardiograms collected as part of a large, United Kingdom-based prospective, multicenter, multivendor study. An ensemble machine learning classifier was trained, using the extracted features, to identify patients with severe coronary artery disease on invasive coronary angiography. The model was tested in an independent U.S. STUDY How availability of an AI classification might impact clinical interpretation of stress echocardiograms was evaluated in a randomized crossover reader study. RESULTS Acceptable classification accuracy for identification of patients with severe coronary artery disease in the training data set was achieved on cross-fold validation based on 31 unique geometric and kinematic features, with a specificity of 92.7% and a sensitivity of 84.4%. This accuracy was maintained in the independent validation data set. The use of the AI classification tool by clinicians increased inter-reader agreement and confidence as well as sensitivity for detection of disease by 10% to achieve an area under the receiver-operating characteristic curve of 0.93. CONCLUSION Automated analysis of stress echocardiograms is possible using AI and provision of automated classifications to clinicians when reading stress echocardiograms could improve accuracy, inter-reader agreement, and reader confidence.
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Affiliation(s)
- Ross Upton
- Ultromics Ltd, Oxford, United Kingdom; Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, Oxford, United Kingdom
| | | | | | | | | | - Shan Gao
- Ultromics Ltd, Oxford, United Kingdom
| | | | - Rizwan Sarwar
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, Oxford, United Kingdom
| | | | | | | | - Jamie M O'Driscoll
- Ultromics Ltd, Oxford, United Kingdom; School of Human and Life Sciences, Canterbury Christ Church University, Kent, United Kingdom
| | | | | | - Cameron Dockerill
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, Oxford, United Kingdom
| | - William Woodward
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, Oxford, United Kingdom
| | - Maryam Alsharqi
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, Oxford, United Kingdom
| | - Annabelle McCourt
- Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, Oxford, United Kingdom
| | | | - Stephen B Heitner
- Knight Cardiovascular Institute, Oregon Health & Science University, Portland Oregon, USA
| | - Mrinal Yadava
- Knight Cardiovascular Institute, Oregon Health & Science University, Portland Oregon, USA
| | - David Stojanovski
- Department of Imaging Sciences and Biomedical Engineering, King's College London, London, United Kingdom
| | - Pablo Lamata
- Department of Imaging Sciences and Biomedical Engineering, King's College London, London, United Kingdom
| | | | - Paul Leeson
- Ultromics Ltd, Oxford, United Kingdom; Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, Oxford, United Kingdom.
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Traumatic low lumbar fractures: How often MRI changes the fracture classification or clinical decision-making compared to CT alone? EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2021; 31:37-45. [PMID: 34625851 DOI: 10.1007/s00586-021-06987-x] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/30/2021] [Revised: 08/11/2021] [Accepted: 09/04/2021] [Indexed: 10/20/2022]
Abstract
PURPOSE To determine the impact of magnetic resonance imaging (MRI) on fracture classification for low lumbar fractures (LLFs) compared to CT alone. METHODS This study was a retrospective review of 41 consecutive patients with LLFs who underwent CT and MRI within 10 days of injury. Three reviewers classified all fractures according to AOSpine Classification and the Thoracolumbar Injury Classification (TLISS). Posterior ligamentous complex (PLC) injury in MRI was defined by black stripe discontinuity and in CT by the presence of: vertebral body translation, facet joint malalignment, horizontal laminar or spinous process fracture, and interspinous widening. The proportion of patients with AO type A/B/C and with TLISS < 5 and ≥ 5 was compared between CT and MRI. We examined the overall accuracy and individual CT findings for PLC injury. RESULTS AO classification using CT was: AO type A in 26 patients (61%), type B in 7 patients (17%), and type C in 8 patients (22%). Seventeen patients (41%) had a TLISS ≥ 5 while 24 (59%) had TLISS < 5. The addition of MRI after CT changed the AO classification in only 2 patients (4.9%, 95% CI (0.6-16.5%) due to upgrade of type A to type B or vice versa, but did not change TLISS from < 5 to ≥ 5 [p< 0.0001; 95% CI (0.59, 0.77)]. CONCLUSIONS CT was highly accurate (95%) for diagnosis of PLC injury in LLFs. Addition of MRI after CT did not change the AO classification or TLISS, compared to CT alone, thus suggesting limited additional value of MRI for PLC assessment or fracture classification.
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Finck T, Schinz D, Grundl L, Eisawy R, Yigitsoy M, Moosbauer J, Pfister F, Wiestler B. Automated Pathology Detection and Patient Triage in Routinely Acquired Head Computed Tomography Scans. Invest Radiol 2021; 56:571-578. [PMID: 33813571 DOI: 10.1097/rli.0000000000000775] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
OBJECTIVES Anomaly detection systems can potentially uncover the entire spectrum of pathologies through deviations from a learned norm, meaningfully supporting the radiologist's workflow. We aim to report on the utility of a weakly supervised machine learning (ML) tool to detect pathologies in head computed tomography (CT) and adequately triage patients in an unselected patient cohort. MATERIALS AND METHODS All patients having undergone a head CT at a tertiary care hospital in March 2020 were eligible for retrospective analysis. Only the first scan of each patient was included. Anomaly detection was performed using a weakly supervised ML technique. Anomalous findings were displayed on voxel-level and pooled to an anomaly score ranging from 0 to 1. Thresholds for this score classified patients into the 3 classes: "normal," "pathological," or "inconclusive." Expert-validated radiological reports with multiclass pathology labels were considered as ground truth. Test assessment was performed with receiver operator characteristics analysis; inconclusive results were pooled to "pathological" predictions for accuracy measurements. External validity was tested in a publicly available external data set (CQ500). RESULTS During the investigation period, 297 patients were referred for head CT of which 248 could be included. Definite ratings into normal/pathological were feasible in 167 patients (67.3%); 81 scans (32.7%) remained inconclusive. The area under the curve to differentiate normal from pathological scans was 0.95 (95% confidence interval, 0.92-0.98) for the study data set and 0.87 (95% confidence interval, 0.81-0.94) in external validation. The negative predictive value to exclude pathology if a scan was classified as "normal" was 100% (25/25), and the positive predictive value was 97.6% (137/141). Sensitivity and specificity were 100% and 86%, respectively. In patients with inconclusive ratings, pathologies were found in 26 (63%) of 41 cases. CONCLUSIONS Our study provides the first clinical evaluation of a weakly supervised anomaly detection system for brain imaging. In an unselected, consecutive patient cohort, definite classification into normal/diseased was feasible in approximately two thirds of scans, going along with an excellent diagnostic accuracy and perfect negative predictive value for excluding pathology. Moreover, anomaly heat maps provide important guidance toward pathology interpretation, also in cases with inconclusive ratings.
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Affiliation(s)
- Tom Finck
- From the Department of Diagnostic and Interventional Neuroradiology, Klinikum Rechts der Isar, Technische Universität München
| | - David Schinz
- From the Department of Diagnostic and Interventional Neuroradiology, Klinikum Rechts der Isar, Technische Universität München
| | - Lioba Grundl
- From the Department of Diagnostic and Interventional Neuroradiology, Klinikum Rechts der Isar, Technische Universität München
| | | | | | | | | | - Benedikt Wiestler
- From the Department of Diagnostic and Interventional Neuroradiology, Klinikum Rechts der Isar, Technische Universität München
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Finck T, Schinz D, Grundl L, Eisawy R, Yiğitsoy M, Moosbauer J, Zimmer C, Pfister F, Wiestler B. Automated Detection of Ischemic Stroke and Subsequent Patient Triage in Routinely Acquired Head CT. Clin Neuroradiol 2021; 32:419-426. [PMID: 34463778 PMCID: PMC9187535 DOI: 10.1007/s00062-021-01081-7] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/24/2021] [Accepted: 08/02/2021] [Indexed: 12/22/2022]
Abstract
Purpose Advanced machine-learning (ML) techniques can potentially detect the entire spectrum of pathology through deviations from a learned norm. We investigated the utility of a weakly supervised ML tool to detect characteristic findings related to ischemic stroke in head CT and provide subsequent patient triage. Methods Patients having undergone non-enhanced head CT at a tertiary care hospital in April 2020 with either no anomalies, subacute or chronic ischemia, lacunar infarcts of the deep white matter or hyperdense vessel signs were retrospectively analyzed. Anomaly detection was performed using a weakly supervised ML classifier. Findings were displayed on a voxel-level (heatmap) and pooled to an anomaly score. Thresholds for this score classified patients into i) normal, ii) inconclusive, iii) pathological. Expert-validated radiological reports were considered as ground truth. Test assessment was performed with ROC analysis; inconclusive results were pooled to pathological predictions for accuracy measurements. Results During the investigation period 208 patients were referred for head CT of which 111 could be included. Definite ratings into normal/pathological were feasible in 77 (69.4%) patients. Based on anomaly scores, the AUC to differentiate normal from pathological scans was 0.98 (95% CI 0.97–1.00). The sensitivity, specificity, positive and negative predictive values were 100%, 40.6%, 80.6% and 100%, respectively. Conclusion Our study demonstrates the potential of a weakly supervised anomaly-detection tool to detect stroke findings in head CT. Definite classification into normal/pathological was made with high accuracy in > 2/3 of patients. Anomaly heatmaps further provide guidance towards pathologies, also in cases with inconclusive ratings.
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Affiliation(s)
- Tom Finck
- Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany.
| | - David Schinz
- Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany
| | - Lioba Grundl
- Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany
| | - Rami Eisawy
- Chair for Computer Aided Medical Procedures & Augmented Reality, Technische Universität München, Munich, Germany
- Deepc GmbH, Munich, Germany
| | | | | | - Claus Zimmer
- Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany
| | | | - Benedikt Wiestler
- Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany
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Can Vertical Laminar Fracture Further Discriminate Fracture Severity Between Thoracolumbar AO Type A3 and A4 Fractures? World Neurosurg 2021; 155:e177-e187. [PMID: 34403797 DOI: 10.1016/j.wneu.2021.08.035] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2021] [Revised: 08/06/2021] [Accepted: 08/07/2021] [Indexed: 11/20/2022]
Abstract
OBJECTIVE To determine whether vertical laminar fracture (VLF) can distinguish between AO type A3 and A4 fractures. METHODS In a retrospective review of 111 consecutive acute thoracolumbar burst fractures, 5 reviewers independently analyzed computed tomography scans to classify fractures into A3 or A4 and to identify VLF. The following computed tomography parameters were measured: spinal canal stenosis >50%, anterior vertebral height ratio <50%, load sharing score >6, and local kyphosis >20°. We calculated the diagnostic performance of VLF in detecting A4 fracture. We compared the proportion of fractures with positive bony parameters, neurological deficit, dural tears, and surgical treatment between A3, A4 with VLF, and A4 without VLF. RESULTS VLF was present in 62/75 (83%) A4 fractures and 2/36 (5.5%) A3 fractures (P < 0.0001). VLF yielded a high specificity of 94% (95% confidence interval 81%-99%) and moderately high sensitivity of 83% (95% CI 72%-91%) in detecting A4 fractures. A significantly higher proportion of A4 fractures with VLF had neurological deficit (24% vs. 0, P = 0.05), spinal canal stenosis >50% (25% vs. 0, P = 0.04), and anterior vertebral height ratio <50% (24% vs. 0, P = 0.05) than A4 fractures with no VLF. Interrater and intrarater κ values for VLF and AO standard criterion were excellent (>0.85). CONCLUSIONS We found VLF to be highly specific, sensitive, and reliable in detecting A4 fractures. A higher proportion of A4 fractures with VLF had radiographic parameters and neurological deficit than A4 fractures with no VLF. VLF could be used as a severity modifier to further discriminate A3 and A4 fractures regarding severity and potentially guide treatment decision making.
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Aly MM, Al-Shoaibi AM, Al Fattani A, AlJuzair AH. Diagnostic Value of Various Morphological Features of Horizontal and Vertical Laminar Fractures for Posterior Ligamentous Complex Injury of the Thoracolumbar Spine as Defined by Magnetic Resonance Imaging. World Neurosurg 2021; 153:e290-e299. [PMID: 34245884 DOI: 10.1016/j.wneu.2021.06.109] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2021] [Revised: 06/21/2021] [Accepted: 06/22/2021] [Indexed: 11/27/2022]
Abstract
OBJECTIVE To determine diagnostic value of morphological features of horizontal laminar fracture (HLF) and vertical laminar fracture (VLF) for diagnosis of posterior ligamentous complex (PLC) injury. METHODS This retrospective review comprised 271 consecutive patients with acute thoracolumbar fractures presenting to a Level 1 trauma center between January 2014 and January 2021. Two reviewers evaluated computed tomography and magnetic resonance imaging. VLFs were subclassified based on length and depth of lamina involved, as follows: type 1, full-length complete; type 2, full-length incomplete; type 3, partial-length complete or incomplete. HLFs were subclassified as follows: bilateral versus unilateral, displaced >2 mm versus nondisplaced, and lamina-only versus laminar and pedicle. We examined the diagnostic accuracy and the univariate and multivariate associations of laminar fracture subtypes with PLC injury as defined by black stripe discontinuity. RESULTS Bilateral HLFs, laminar and pedicle fractures, displaced HLFs, and type 1 VLFs yielded a high positive predictive value for PLC injury (95%, 91%, 100%, and 86%, respectively). Type 2 and 3 VLFs did not show significant univariate associations with PLC injury. Bilateral HLFs, laminar and pedicle fractures, and displaced HLFs showed independent associations with PLC injury (adjusted odds ratio = 13.6, 8.4, 6, and 10.3, respectively; P < 0.002). Type 1 VLFs did not show a significant association with PLC (adjusted odds ratio = 10.3; P = 0.06). CONCLUSIONS Bilateral HLFs, laminar and pedicle fractures, and displaced HLFs, but not any VLF subtypes, were independently associated with PLC injury. These findings may improve the reliability of PLC assessment by computed tomography.
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Affiliation(s)
- Mohamed M Aly
- Department of Neurosurgery, Mansoura University, Mansoura, Egypt; Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia.
| | - Abdulbaset M Al-Shoaibi
- Department of Diagnostic Radiology, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
| | - Areej Al Fattani
- Department of Biostatistics Epidemiology and Scientific Computing, King Faisal Specialist Hospital and Research Hospital, Riyadh, Saudi Arabia
| | - Ali Hassan AlJuzair
- Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
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García-Fiñana M, Hughes DM, Cheyne CP, Burnside G, Stockbridge M, Fowler TA, Fowler VL, Wilcox MH, Semple MG, Buchan I. Performance of the Innova SARS-CoV-2 antigen rapid lateral flow test in the Liverpool asymptomatic testing pilot: population based cohort study. BMJ 2021; 374:n1637. [PMID: 34230058 PMCID: PMC8259455 DOI: 10.1136/bmj.n1637] [Citation(s) in RCA: 54] [Impact Index Per Article: 13.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 06/22/2021] [Indexed: 01/09/2023]
Abstract
OBJECTIVE To assess the performance of the SARS-CoV-2 antigen rapid lateral flow test (LFT) versus polymerase chain reaction testing in the asymptomatic general population attending testing centres. DESIGN Observational cohort study. SETTING Community LFT pilot at covid-19 testing sites in Liverpool, UK. PARTICIPANTS 5869 asymptomatic adults (≥18 years) voluntarily attending one of 48 testing sites during 6-29 November 2020. INTERVENTIONS Participants were tested using both an Innova LFT and a quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) test based on supervised self-administered swabbing at testing sites. MAIN OUTCOME MEASURES Sensitivity, specificity, and predictive values of LFT compared with RT-qPCR in an epidemic steady state of covid-19 among adults with no classic symptoms of the disease. RESULTS Of 5869 test results, 22 (0.4%) LFT results and 343 (5.8%) RT-qPCR results were void (that is, when the control line fails to appear within 30 minutes). Excluding the void results, the LFT versus RT-qPCR showed a sensitivity of 40.0% (95% confidence interval 28.5% to 52.4%; 28/70), specificity of 99.9% (99.8% to 99.99%; 5431/5434), positive predictive value of 90.3% (74.2% to 98.0%; 28/31), and negative predictive value of 99.2% (99.0% to 99.4%; 5431/5473). When the void samples were assumed to be negative, a sensitivity was observed for LFT of 37.8% (26.8% to 49.9%; 28/74), specificity of 99.6% (99.4% to 99.8%; 5431/5452), positive predictive value of 84.8% (68.1% to 94.9%; 28/33), and negative predictive value of 93.4% (92.7% to 94.0%; 5431/5814). The sensitivity in participants with an RT-qPCR cycle threshold (Ct) of <18.3 (approximate viral loads >106 RNA copies/mL) was 90.9% (58.7% to 99.8%; 10/11), a Ct of <24.4 (>104 RNA copies/mL) was 69.4% (51.9% to 83.7%; 25/36), and a Ct of >24.4 (<104 RNA copies/mL) was 9.7% (1.9% to 23.7%; 3/34). LFT is likely to detect at least three fifths and at most 998 in every 1000 people with a positive RT-qPCR test result with high viral load. CONCLUSIONS The Innova LFT can be useful for identifying infections among adults who report no symptoms of covid-19, particularly those with high viral load who are more likely to infect others. The number of asymptomatic adults with lower Ct (indicating higher viral load) missed by LFT, although small, should be considered when using single LFT in high consequence settings. Clear and accurate communication with the public about how to interpret test results is important, given the chance of missing some cases, even at high viral loads. Further research is needed to understand how infectiousness is reflected in the viral antigen shedding detected by LFT versus the viral loads approximated by RT-qPCR.
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Affiliation(s)
- Marta García-Fiñana
- Department of Health Data Science, Institute of Population Health, University of Liverpool, Liverpool, UK
| | - David M Hughes
- Department of Health Data Science, Institute of Population Health, University of Liverpool, Liverpool, UK
| | - Christopher P Cheyne
- Department of Health Data Science, Institute of Population Health, University of Liverpool, Liverpool, UK
| | - Girvan Burnside
- Department of Health Data Science, Institute of Population Health, University of Liverpool, Liverpool, UK
| | | | - Tom A Fowler
- Department of Health and Social Care, London, UK
- William Harvey Research Institute, Queen Mary University of London, London, UK
| | | | - Mark H Wilcox
- Leeds Institute of Medical Research, University of Leeds, Leeds, UK
| | - Malcolm G Semple
- NIHR Health Protection Research Unit in Emerging and Zoonotic Infections and Institute of Translational Medicine, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK
- Respiratory Medicine, Alder Hey Children's Hospital, Liverpool, UK
| | - Iain Buchan
- Institute of Population Health Sciences, University of Liverpool, Liverpool, UK
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Pillay S, Davies GR, Chaplin M, De Vos M, Schumacher SG, Warren R, Steingart KR, Theron G. Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin. Hippokratia 2021. [DOI: 10.1002/14651858.cd014841] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Affiliation(s)
- Samantha Pillay
- DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research; South African Medical Research Council Centre for Tuberculosis Research; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences; Stellenbosch University; Cape Town South Africa
| | - Geraint R Davies
- Institute of Infection, Veterinary and Ecological Sciences; University of Liverpool; Liverpool UK
| | - Marty Chaplin
- Department of Clinical Sciences; Liverpool School of Tropical Medicine; Liverpool UK
| | | | | | - Rob Warren
- DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research; South African Medical Research Council Centre for Tuberculosis Research; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences; Stellenbosch University; Cape Town South Africa
| | - Karen R Steingart
- Honorary Research Fellow; Department of Clinical Sciences, Liverpool School of Tropical Medicine; Liverpool UK
| | - Grant Theron
- DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research; South African Medical Research Council Centre for Tuberculosis Research; Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences; Stellenbosch University; Cape Town South Africa
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Forensic science and the principle of excluded middle: "Inconclusive" decisions and the structure of error rate studies. Forensic Sci Int Synerg 2021; 3:100147. [PMID: 33981984 PMCID: PMC8082088 DOI: 10.1016/j.fsisyn.2021.100147] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2021] [Revised: 03/20/2021] [Accepted: 03/29/2021] [Indexed: 11/21/2022]
Abstract
In a paper published recently in this journal, Dror and Scurich (2020) [20] critically discuss the notions of "inconclusive evidence" (i.e., test items for which it is difficult to render a categorical response) and "inconclusive decisions" (i.e., experts' conclusions or responses) in the context of forensic science error rate studies. They expose several ways in which the understanding and use of "inconclusives" in current forensic science research and practice can adversely affect the outcomes of error rate studies. A main cause of distortion, according to Dror and Scurich, is what they call "erroneous inconclusive" decisions, in particular the lack of acknowledgment of this type of erroneous conclusion in the computation of error rates. To overcome this complication, Dror and Scurich call for a more explicit monitoring of "inconclusives" using a modified error rate study design. Whilst we agree with several well-argued points raised by the authors, we disagree with their framing of "inconclusive decisions" as potential errors. In this paper, we argue that referring to an "inconclusive decision" as an error is a contradiction in terms, runs counter to an analysis based on decision logic and, hence, is questionable as a concept. We also reiterate that the very term "inconclusive decision" disregards the procedural architecture of the criminal justice system across modern jurisdictions, especially the fact that forensic experts have no decisional rights in the criminal process. These positions do not ignore the possibility that "inconclusives" - if used excessively - do raise problems in forensic expert reporting, in particular limited assertiveness (or, overcautiousness). However, these drawbacks derive from inherent limitations of experts rather than from the seemingly erroneous nature of "inconclusives" that needs to be fixed. More fundamentally, we argue that attempts to score "inconclusives" as errors amount to philosophical claims disguised as forensic methodology. Specifically, these attempts interfere with the metaphysical substrate underpinning empirical research. We point this out on the basis of the law of the excluded middle, i.e. the principle of "no third possibility being given" (tertium non datur).
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Su N, Lagerweij MD, van der Heijden GJMG. Assessment of predictive performance of caries risk assessment models based on a systematic review and meta-analysis. J Dent 2021; 110:103664. [PMID: 33984413 DOI: 10.1016/j.jdent.2021.103664] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/23/2020] [Revised: 03/05/2021] [Accepted: 04/09/2021] [Indexed: 12/23/2022] Open
Abstract
OBJECTIVES To assess the predictive performance of caries risk assessment (CRA) models for prediction of caries increment for individuals based on a systematic review and meta-analyses. DATA/SOURCES We included external validation studies assessing the predictive performance of CRA models for prediction of caries increment for individuals, using discrimination and calibration as the outcome parameters. PubMed, EMBASE, and CINAHL were searched electronically on 10th September 2020 to identify prediction modeling studies on external validation of CRA models. The risk of bias of the included studies was assessed using the Prediction model Risk Of Bias ASsessment Tool (PROBAST). STUDY SELECTION A total of 22 studies with seven different CRA models were included. As for full Cariogram, the pooled area under the receiver operating characteristic curve (AUC) was 0.78 (95 %CI: 0.68; 0.85) based on eight studies regardless of the risk of bias levels, and 0.82 (95 %CI: 0.58; 0.93) based on four studies with low risk of bias only. The pooled observed: expected ratio (O:E ratio) of full Cariogram was 0.91 (95 %CI: 0.72; 1.14) based on 12 studies regardless of the risk of bias levels, and 0.89 (95 %CI: 0.71; 1.12) based on five studies with low risk of bias only. As for reduced Cariogram, the pooled AUC was 0.72 (95 %CI: 0.67; 0.77) based on six studies regardless of the risk of bias levels, and 0.74 (95 %CI: 0.45; 0.91) based on two studies with low risk of bias only. The pooled O:E ratio of reduced Cariogram was 0.84 (95 %CI: 0.59; 1.18) based on six studies regardless of the risk of bias levels, and 1.05 (95 %CI: 0.43; 2.59) based on two studies with low risk of bias only. Based on an insufficient number of studies for the other CRA models, the pooled AUCs ranged from 0.50 to 0.88, while the pooled O:E ratio ranged from 0.38 to 1.00. CONCLUSION The average predictive performance of both full and reduced Cariogram seems to be acceptable. However, the evidence from research does not allow a firm conclusion on the performance of the other included CRA models, due to the insufficient number of high-quality studies. CLINICAL SIGNIFICANCE Both full and reduced Cariogram were found to be reliable CRA models for prediction of caries increment in clinical practices for dental patients and communities for general populations. The reduced Cariogram showed better predictive performance and less burden in terms of time and resources to individuals than the full Cariogram. Therefore, the reduced Cariogram could be more recommended than the full Cariogram.
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Affiliation(s)
- Naichuan Su
- Department of Social Dentistry, Academic Centre for Dentistry Amsterdam (ACTA), University of Amasterdam and VU University, the Netherlands.
| | - Maxim D Lagerweij
- Department of Cariology, Endodontology and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amasterdam and VU University, the Netherlands
| | - Geert J M G van der Heijden
- Department of Social Dentistry, Academic Centre for Dentistry Amsterdam (ACTA), University of Amasterdam and VU University, the Netherlands
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Aly MM, Al-Shoaibi AM, Alzahrani AJ, Al Fattani A. Analysis of the Combined Computed Tomography Findings Improves the Accuracy of Computed Tomography for Detecting Posterior Ligamentous Complex Injury of the Thoracolumbar Spine as Defined by Magnetic Resonance Imaging. World Neurosurg 2021; 151:e760-e770. [PMID: 33940257 DOI: 10.1016/j.wneu.2021.04.106] [Citation(s) in RCA: 22] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/30/2021] [Revised: 04/21/2021] [Accepted: 04/23/2021] [Indexed: 10/21/2022]
Abstract
OBJECTIVE To determine the diagnostic accuracy of combined computed tomography (CT) findings for detecting posterior ligamentous complex (PLC) injury in thoracolumbar fractures using magnetic resonance imaging as a reference. METHODS A retrospective review of 263 consecutive patients with thoracolumbar fractures who underwent CT and magnetic resonance imaging within 10 days of injury. Two reviewers evaluated CT for the following findings: facet joint malalignment, facet joint widening, horizontal laminar fracture, spinous process fracture, and interspinous widening. We examined the independent association of CT findings with PLC injury before combining the CT findings to calculate the diagnostic accuracy: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), and positive and negative likelihood ratios. PLC injury was defined by black stripe discontinuity caused by supraspinous or ligamentum flavum rupture. RESULTS Facet joint malalignment, spinous process fracture, horizontal laminar fracture, and interspinous widening were independently associated with PLC injury (adjusted odds ratio range, 4.4e17.4). A single positive CT finding yielded a PPV of 31% and NPV of 66% for PLC injury. Two or more CT findings yielded a PPV of 91% for PLC injury. A negative CT for all the 4 CT sings had a 94% NPV for PLC injury. CONCLUSIONS Two or more CT findings provided the best combination to confirm PLC injury; thus, this combination could be used as a criterion for injured PLC. A single CT finding lacks sufficient predictive value to confirm or rule out PLC injury. A negative CT for the 4 CT findings provided the highest sensitivity for PLC injuries.
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Affiliation(s)
- Mohamed M Aly
- Department of Neurosurgery, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia; Department of Neurosurgery, Mansoura University, Mansoura, Egypt.
| | - Abdulbaset M Al-Shoaibi
- Department of Diagnostic Radiology, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
| | - Ahmed J Alzahrani
- Department of Neurosurgery, Security Forces Hospital, Riyadh, Saudi Arabia
| | - Areej Al Fattani
- Department of Biostatistics Epidemiology and Scientific Computing, King Faisal Specialist Hospital and Research Hospital, Riyadh, Saudi Arabia
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Mumoli N, Vitale J, Pagnamenta A, Mastroiacovo D, Cei M, Pomero F, Giorgi-Pierfranceschi M, Giuntini L, Porta C, Capra R, Mazzone A, Dentali F. Bedside Abdominal Ultrasound in Evaluating Nasogastric Tube Placement: A Multicenter, Prospective, Cohort Study. Chest 2021; 159:2366-2372. [PMID: 33545162 DOI: 10.1016/j.chest.2021.01.058] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2020] [Revised: 01/12/2021] [Accepted: 01/14/2021] [Indexed: 01/12/2023] Open
Abstract
BACKGROUND Chest radiography is universally accepted as the method of choice to confirm correct positioning of a nasogastric tube (NGT). Considering also that radiation exposure could increase with multiple insertions in a single patient, bedside abdominal ultrasound (BAU) may be a potentially useful alternative to chest radiography in the management of NGTs. RESEARCH QUESTION What is the accuracy of BAU in confirming the correct positioning of an NGT? STUDY DESIGN AND METHODS After a specific course consisting of 10 h of training, the authors studied, in a prospective multicenter cohort, the validity of BAU to confirm correct NGT placement. All patients were also evaluated by auscultation (whoosh test) and by chest radiography. Every involved operator was blind to each other. Interobserver agreement and accuracy analyses were calculated. RESULTS This study evaluated 606 consecutive inpatients with an indication for NGT insertion. Eighty patients were excluded for protocol violation or incomplete examinations and 526 were analyzed. BAU was positive, negative, and inconclusive in 415 (78.9%), 71 (13.5%), and 40 (7.6%), respectively. The agreement between BAU and chest radiography was excellent. Excluding inconclusive results, BAU had a sensitivity of 99.8% (99.3%-100%), a specificity of 91.0% (88.5%-93.6%), a positive predictive value of 98.3% (97.2%-99.5%), and a negative predictive value of 98.6% (97.6%-99.7%). The accuracy of BAU slightly changed according to the different assignments of the uncertain cases and was improved by the exclusion of patients with an altered level of consciousness. INTERPRETATION These results suggest that BAU has a good positive predictive value and may confirm the correct placement of NGTs when compared with chest radiography. However, considering its suboptimal specificity, caution is necessary before implementing this technique in clinical practice.
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Affiliation(s)
- Nicola Mumoli
- Department of Internal Medicine, Livorno Hospital, Livorno, Italy; Department of Internal Medicine, ASST Ovest Milanese, Magenta, Italy.
| | - Josè Vitale
- Department of Intensive Medicine, Intensive Care Unit and Biostatistics Unit, Regional Hospital Mendrisio, Ente Ospedaliero Cantonale, Switzerland
| | - Alberto Pagnamenta
- Department of Intensive Medicine, Intensive Care Unit and Biostatistics Unit, Regional Hospital Mendrisio, Ente Ospedaliero Cantonale, Switzerland
| | | | - Marco Cei
- Department of Internal Medicine, Cecina Hospital, Cecina, Italy
| | - Fulvio Pomero
- Department of Internal Medicine, Michele e Pietro Ferrero Hospital, Verduno, Italy
| | | | - Lucia Giuntini
- Department of Internal Medicine, Livorno Hospital, Livorno, Italy
| | - Cesare Porta
- Department of Internal Medicine, ASST Ovest Milanese, Magenta, Italy
| | - Riccardo Capra
- Department of Internal Medicine, ASST Ovest Milanese, Magenta, Italy
| | - Antonino Mazzone
- Department of Internal Medicine, ASST Ovest Milanese, Magenta, Italy
| | - Francesco Dentali
- Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy
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Ogden NKE, Milner PI, Stack JD, Talbot AM. CT more accurately detects foreign bodies within the equine foot than MRI or digital radiography. Vet Radiol Ultrasound 2020; 62:225-235. [PMID: 33325609 DOI: 10.1111/vru.12944] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/24/2020] [Revised: 10/25/2020] [Accepted: 11/01/2020] [Indexed: 11/27/2022] Open
Abstract
Identification and characterization of foreign bodies in the distal limb of horses poses a diagnostic challenge. The aims of this prospective experimental cadaver study were to describe the appearance of five foreign body materials within the equine hoof using CT, MRI, and digital radiography (DR) and to compare interrater agreement among three reviewers. Fifty foreign bodies consisting of five materials were implanted at a solar location or a coronary location in 25 equine cadaver feet. The images were reviewed by three equine veterinarians experienced in advanced imaging interpretation, who were blinded to the material of the foreign body. Foreign bodies were graded on visibility and appearance. Sensitivity and specificity were calculated for accurate identification of the different materials. Interrater agreement was assessed using Fleiss' kappa. Computed tomography had higher visibility score, sensitivity/specificity, and interrater agreement for detection of all materials; particularly slate, glass, and dry wood, compared to the other imaging modalities. Soaked wood and plastic had lower sensitivity (31-33%) on CT with a similar attenuation of the two materials. Foreign bodies were often visible on MRI, although with similar appearance and unclear details. On DR, only slate and glass were visible. The interrater agreement for identifying the correct material was almost perfect for slate, glass, and dry wood (κ = 0.92-1.00) and poor for plastic and soaked wood (κ < 0.20) on CT. Interrater agreement was poor for all materials on MRI and DR (κ < 0.20), with the except for fair (κ = 0.28) for slate on DR and moderate (κ = 0.28) for soaked wood on MRI.
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Affiliation(s)
- Nadine K E Ogden
- Philip Leverhulme Equine Hospital, University of Liverpool, Neston, UK
| | - Peter I Milner
- Philip Leverhulme Equine Hospital, University of Liverpool, Neston, UK
| | - John D Stack
- Philip Leverhulme Equine Hospital, University of Liverpool, Neston, UK
| | - Alison M Talbot
- Philip Leverhulme Equine Hospital, University of Liverpool, Neston, UK
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Wesali S, Demir MA, Verbeke CS, Andersson M, Bratlie SO, Sadik R. EUS is accurate in characterizing pancreatic cystic lesions; a prospective comparison with cross-sectional imaging in resected cases. Surg Endosc 2020; 35:6650-6659. [PMID: 33259018 PMCID: PMC8599246 DOI: 10.1007/s00464-020-08166-3] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/07/2020] [Accepted: 11/15/2020] [Indexed: 01/04/2023]
Abstract
Background Imaging modalities for characterizing pancreatic cystic lesions (PCLs) is a known uncertainty. The aim of this prospective study was to compare the diagnostic performance of endoscopic ultrasound morphology, cytology and cyst fluid carcinoembryonic antigen (EUS-FNA-CEA) with cross-sectional imaging in resected PCLs. Methods The cross-sectional imaging and EUS-FNA-CEA results were collected in an academic tertiary referral centre using histology of the surgical specimen as the diagnostic standard. Results Of 289 patients undergoing evaluation for PCL with cross-sectional imaging and EUS-FNA between February 2007 and March 2017, 58 underwent surgical resection providing a final diagnosis of the PCLs: 45 mucinous, 5 serous, 1 pseudocyst, 2 endocrine, 2 solid pseudopapillary neoplasms and 3 other. EUS-FNA-CEA was more accurate than cross-sectional imaging in diagnosing mucinous PCLs (95% vs. 83%, p = 0.04). Ninety-two percent of the PCLs with high-grade dysplasia or adenocarcinoma were smaller than 3 cm in diameter. The sensitivity of EUS-FNA-CEA and cross-sectional imaging for detecting PCLs with high-grade dysplasia or adenocarcinoma were 33% and 5% (p = 0.03), respectively. However, there was no difference in accuracy between the modalities (62% vs. 66%, p = 0.79). The sensitivity for detecting pancreatic adenocarcinomas only was 64% for EUS-FNA-CEA and 9% for cross-sectional imaging (p = 0.03). Overall, EUS-FNA-CEA provided a correct diagnosis in more patients with PCLs than cross-sectional imaging (72% vs. 50%, p = 0.01). Conclusions EUS-FNA-CEA is accurate and should be considered a complementary test in the diagnosis of PCLs. However, the detection of PCLs with high-grade dysplasia or adenocarcinoma needs to be improved. Cyst size does not seem to be a reliable predictor of high-grade dysplasia or adenocarcinoma. Electronic supplementary material The online version of this article (10.1007/s00464-020-08166-3) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Sahar Wesali
- Department of Gastroenterology and Hepatology, Sahlgrenska University Hospital, Gothenburg, Sweden.
| | - Mehmet A Demir
- Department of Clinical Pathology, Rigshospitalet, Copenhagen, Denmark
| | - Caroline S Verbeke
- Department of Pathology, University of Oslo, and Oslo University Hospital, Oslo, Norway
| | - Mats Andersson
- Department of Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.,Division of Radiology, Karolinska University Hospital Huddinge, Stockholm, Sweden
| | - Svein Olav Bratlie
- Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Riadh Sadik
- Department of Gastroenterology and Hepatology, Sahlgrenska University Hospital, Gothenburg, Sweden
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Young AE, Thet NT, Mercer-Chalmers J, Greenwood RJ, Coy K, Booth S, Sack A, Jenkins ATA. The SPaCE diagnostic: a pilot study to test the accuracy of a novel point of care sensor for point of care detection of burn wound infection. J Hosp Infect 2020; 106:726-733. [PMID: 33022335 DOI: 10.1016/j.jhin.2020.09.033] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2020] [Revised: 09/28/2020] [Accepted: 09/28/2020] [Indexed: 10/23/2022]
Abstract
BACKGROUND Wound infection in burn patients is common and has an impact on outcomes. There is no objective method to diagnose infection at point of care (PoC). Early diagnosis prevents progression to sepsis. Diagnostic subjectivity supports over-diagnosis, unnecessary hospitalization, and antibiotic overuse. AIM This pilot study aimed to investigate the accuracy of a novel PoC wound infection diagnostic in burn patients. METHODS We produced, and in vitro tested, a PoC diagnostic for early wound infection diagnosis. The prototype SPaCE diagnostic uses a patented lipid vesicle suspension into which a clinical swab is placed. The diagnostic delivers a colour-response to Staphylococcus aureus, Pseudomonas aeruginosa, Candida species and Enterococcus faecalis at toxin release. A pilot clinical diagnostic accuracy study was undertaken. The reference standard was a retrospective decision made by an expert clinical panel using routinely available data. FINDINGS Data was available from 33 of 34 patients. Of these, 52% were considered to have a wound infection, 42% not, and two (6%) were equivocal. The diagnostic results showed 24% were infected, 42% were not and 33% produced intermediate results. Agreement between clinical judgement and diagnostic result, assessed using a weighted Kappa, was 0.591 suggesting moderate agreement. If the intermediate results were excluded, 22 sets of data with definitive results achieved a Kappa statistic of 0.81 suggesting 'almost perfect' agreement. Sensitivity and specificity were 57% (8/14) and 71% (12/17), respectively. CONCLUSION This pilot study provided evidence that the SPaCE diagnostic could provide valuable and timely data to support clinical decision-making at PoC for wound infection.
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Affiliation(s)
- A E Young
- Children's Burn Research Centre, University Hospital Bristol and Weston NHS Foundation Trust, Bristol, UK; Bristol Centre for Surgical Research, Bristol Medical School University of Bristol, Bristol, UK.
| | - N T Thet
- Chemistry Department, University of Bath, Bath, UK
| | | | - R J Greenwood
- Research Design Service, Education Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - K Coy
- Bristol Centre for Surgical Research, Bristol Medical School University of Bristol, Bristol, UK
| | - S Booth
- Queen Victoria Hospital NHS Foundation Trust, East Grinstead, UK
| | - A Sack
- Southmead Hospital, North Bristol NHS Foundation Trust, Bristol, UK
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Cazzato RL, De Marini P, Auloge P, Leclerc L, Tricard T, Linder V, Jost M, Ramamurthy N, Lang H, Garnon J, Gangi A. Diagnostic accuracy and safety of percutaneous MRI-guided biopsy of solid renal masses: single-center results after 4.5 years. Eur Radiol 2020; 31:580-590. [PMID: 32851448 DOI: 10.1007/s00330-020-07160-6] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2020] [Revised: 06/13/2020] [Accepted: 08/06/2020] [Indexed: 12/31/2022]
Abstract
OBJECTIVES To retrospectively evaluate diagnostic accuracy and complications of magnetic resonance imaging (MRI)-guided biopsy of radiologically indeterminate solid renal masses (RM). METHODS Electronic records of all consecutive patients undergoing MRI-guided biopsy of solid RM (using free-breathing T2-BLADE and BEAT-IRTTT sequences) between April 2014 and October 2018 were reviewed; 101 patients (69 men, 32 women; median age 68 years; range 32-76) were included. Patient and RM characteristics, procedural details/complications, pathologic diagnosis, and clinical management were recorded. Diagnostic accuracy was calculated on an intention-to-diagnose basis. Diagnostic yield was also evaluated. Multi-variable analysis was performed for variables with p < .20, including patient age/sex; RM size/location/contact with vascular pedicle, RENAL score, number and total length of biopsy samples, and biopsy tract embolization, to determine factors associated with diagnostic samples, diagnostic accuracy, and complications. RESULTS Median RM size was 2.4 cm (range 1-8.4 cm). There were 86 (85%; 95%CI 77-91%) diagnostic and 15 (15%; 95%CI 9-23%) non-diagnostic samples; 6/15 (40%) non-diagnostic biopsies were repeated with 50% malignancy rate. Sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy were 96% (95%CI 89-99%), 100% (95%CI 77-100%), 100% (95%CI 95-100%), 82% (95%CI 57-96%), and 97% (95%CI 90-99%), respectively. Primary and secondary diagnostic yields were 85% (95%CI 77-91%) and 91% (95%CI 84-96%), respectively. Seven (7%; 95%CI 1-10%) complications were observed. No tested variables were associated with diagnostic samples, diagnostic accuracy, or complications. CONCLUSIONS MRI-guided biopsy of solid RM is associated with high diagnostic accuracy and low complication rate. The technique might be helpful for inaccessible tumors. KEY POINTS • MRI-guided biopsy of radiologically indeterminate solid renal masses (RM) appears safe, with a low rate of minor self-limiting hemorrhagic complications. • Diagnostic accuracy and primary/secondary diagnostic yield are high and appear similar to reported estimates for US- and CT-guided RM biopsy. • MRI guidance may be particularly useful for RM with poor conspicuity on US and CT, for relatively inaccessible tumors (e.g., tumors requiring double-oblique steep-angled approaches), and for young patients or those with renal failure.
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Affiliation(s)
- Roberto Luigi Cazzato
- Department of Interventional Radiology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France.
| | - Pierre De Marini
- Department of Interventional Radiology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France
| | - Pierre Auloge
- Department of Interventional Radiology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France
| | - Loic Leclerc
- Department of Interventional Radiology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France
| | - Thibault Tricard
- Department of Urology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France
| | - Veronique Linder
- Department of Pathology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France
| | - Marion Jost
- Department of Pathology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France
| | - Nitin Ramamurthy
- Department of Radiology, Norfolk and Norwich University Hospital, Colney Ln, Norwich, NR4 7UY, UK
| | - Hervé Lang
- Department of Urology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France
| | - Julien Garnon
- Department of Interventional Radiology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France
| | - Afshin Gangi
- Department of Interventional Radiology, University Hospital of Strasbourg, 1, place de l'hôpital, 67000, Strasbourg, France
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Salameh JP, Bossuyt PM, McGrath TA, Thombs BD, Hyde CJ, Macaskill P, Deeks JJ, Leeflang M, Korevaar DA, Whiting P, Takwoingi Y, Reitsma JB, Cohen JF, Frank RA, Hunt HA, Hooft L, Rutjes AWS, Willis BH, Gatsonis C, Levis B, Moher D, McInnes MDF. Preferred reporting items for systematic review and meta-analysis of diagnostic test accuracy studies (PRISMA-DTA): explanation, elaboration, and checklist. BMJ 2020; 370:m2632. [PMID: 32816740 DOI: 10.1136/bmj.m2632] [Citation(s) in RCA: 319] [Impact Index Per Article: 63.8] [Reference Citation Analysis] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Affiliation(s)
- Jean-Paul Salameh
- Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa, ON, Canada
| | - Patrick M Bossuyt
- Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centres, University Medical Centres, University of Amsterdam, Amsterdam, Netherlands
| | - Trevor A McGrath
- University of Ottawa Department of Radiology, Ottawa, ON, Canada
| | - Brett D Thombs
- Lady Davis Institute of the Jewish General Hospital and Department of Psychiatry, McGill University, Montréal, QC, Canada
| | - Christopher J Hyde
- Exeter Test Group, College of Medicine and Health, University of Exeter, Exeter, UK
| | | | - Jonathan J Deeks
- Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK
| | - Mariska Leeflang
- Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University Medical Centres, University of Amsterdam, Amsterdam, Netherlands
| | - Daniël A Korevaar
- Department of Respiratory Medicine, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, Netherlands
| | - Penny Whiting
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
| | - Yemisi Takwoingi
- Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK
| | - Johannes B Reitsma
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Cochrane Netherlands, Utrecht, Netherlands
| | - Jérémie F Cohen
- Department of Paediatrics and Inserm UMR 1153 (Centre of Research in Epidemiology and Statistics), Necker-Enfants Malades Hospital, Assistance Publique-Hôpitaux de Paris, Paris Descartes University, Paris, France
| | - Robert A Frank
- University of Ottawa Department of Radiology, Ottawa, ON, Canada
| | - Harriet A Hunt
- Exeter Test Group, College of Medicine and Health, University of Exeter, Exeter, UK
| | - Lotty Hooft
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Cochrane Netherlands, Utrecht, Netherlands
| | - Anne W S Rutjes
- Institute of Social and Preventive Medicine, Berner Institut für Hausarztmedizin, University of Bern, Bern, Switzerland
| | | | | | - Brooke Levis
- Lady Davis Institute of the Jewish General Hospital and Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, QC, Canada
| | - David Moher
- Ottawa Hospital Research Institute Clinical Epidemiology Program (Centre for Journalology), Ottawa, ON, Canada
| | - Matthew D F McInnes
- Clinical Epidemiology Programme, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON K1E 4M9, Canada
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Petersen LJ, Johansen MN, Strandberg J, Stenholt L, Zacho HD. Reporting and handling of equivocal imaging findings in diagnostic studies of bone metastasis in prostate cancer. Acta Radiol 2020; 61:1096-1104. [PMID: 31821767 DOI: 10.1177/0284185119890087] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
BACKGROUND Equivocal scanning results occur. It remains unclear how these results are presented and their management influence diagnostic characteristics. PURPOSE To investigate the reporting and handling of equivocal imaging findings in diagnostic studies of bone metastases, and to assess the impact on diagnostic performance of the methods used to analyze equivocal findings. The conceptual issue was reified based on two actual observations. MATERIAL AND METHODS A recent meta-analysis of bone metastases in prostate cancer was conducted and data were obtained from a large clinical trial with a true reference of bone metastasis, where diagnostic characteristics were calculated with equivocal scans handled by: removal; considered malignant; considered benign; and intention-to-diagnose. RESULTS The meta-analysis included 18 trials where the median proportion of reported equivocal results was 27%. Eleven (61%) studies reported an equivocal option for the index test, 42% reported equivocal results and described how these were analyzed. The clinical trial included 583 prostate cancer patients with 20% equivocal results. The different methods of managing equivocal findings resulted in highly variable outcomes: sensitivity = 85%-100%; specificity = 78%-99%; and positive and negative predictive values = 44%-94% and 97%-100%, respectively. The diagnostic performances obtained using the four methods were differentially susceptible to the proportion of equivocal imaging findings and the prevalence of bone metastases. CONCLUSION Reporting of equivocal results was inadequate in bone imaging trials. The handling of equivocal findings strongly influenced diagnostic accuracy.
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Affiliation(s)
- Lars J Petersen
- Department of Nuclear Medicine, Clinical Cancer Research Centre, Aalborg University Hospital, Aalborg, Denmark
- Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
| | | | - Jesper Strandberg
- Department of Nuclear Medicine, Clinical Cancer Research Centre, Aalborg University Hospital, Aalborg, Denmark
| | - Louise Stenholt
- The Medical Library, Aalborg University Hospital, Aalborg, Denmark
| | - Helle D Zacho
- Department of Nuclear Medicine, Clinical Cancer Research Centre, Aalborg University Hospital, Aalborg, Denmark
- Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
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Jang MA, Kim B, Lee YK. Reporting Quality of Diagnostic Accuracy Studies in Laboratory Medicine: Adherence to Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015. Ann Lab Med 2020; 40:245-252. [PMID: 31858765 PMCID: PMC6933069 DOI: 10.3343/alm.2020.40.3.245] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2019] [Revised: 08/23/2019] [Accepted: 11/22/2019] [Indexed: 12/21/2022] Open
Abstract
Background Poor reporting quality in diagnostic accuracy studies hampers an adequate judgment of the validity of the study. The Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was published to improve the reporting quality of diagnostic accuracy studies. This study aimed to evaluate the adherence of diagnostic accuracy studies published in Annals of Laboratory Medicine (ALM) to STARD 2015 and to identify directions for improvement in the reporting quality of these studies. Methods Two independent authors assessed articles published in ALM between 2012–2018 for compliance with 30 STARD 2015 checklist items to identify all eligible diagnostic accuracy studies published during this period. We included 66 diagnostic accuracy studies. A total of the fulfilled STARD items were calculated, and adherence was analyzed on an individual-item basis. Results The overall mean±SD number of STARD items reported for the included studies was 11.2±2.7. Only five (7.6%) studies adhered to more than 50% of the 30 items. No study satisfied more than 80% of the items. Large variability in adherence to reporting standards was detected across items, ranging from 0% to 100%. Conclusions Adherence to STARD 2015 is suboptimal among diagnostic accuracy studies published in ALM. Our study emphasizes the necessity of adherence to STARD to improve the reporting quality of future diagnostic accuracy studies to be published in ALM.
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Affiliation(s)
- Mi Ae Jang
- Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Bohyun Kim
- Department of Laboratory Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea
| | - You Kyoung Lee
- Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
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Naha N, Muhamed JC, Pagdhune A, Sarkar B, Sarkar K. Club cell protein 16 as a biomarker for early detection of silicosis. Indian J Med Res 2020; 151:319-325. [PMID: 32461395 PMCID: PMC7371066 DOI: 10.4103/ijmr.ijmr_1799_18] [Citation(s) in RCA: 22] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2018] [Indexed: 12/18/2022] Open
Abstract
BACKGROUND & OBJECTIVES Clinically silicosis is diagnosed by chest X-ray showing specific opacities along with history of silica dust exposure. Diagnosis is invariably made at an advanced or end stage when it is irreversible. Moreover, silicosis patients are susceptible to develop tuberculosis. Therefore, a suitable biomarker for early detection of silicosis is needed. This study evaluated the suitability of club cell protein (CC16) as a biomarker for early detection of silicosis. METHODS This pilot study included 121 individuals from X-ray-confirmed/advanced silicosis, moderate silica dust-exposed workers and healthy controls from western India. CC16 levels were quantified in serum samples through ELISA. Sensitivity and specificity of CC16 values at different cut-off points were calculated in both non-smokers and smokers. RESULTS Serum CC16 level was significantly (P <0.01) decreased in X-ray confirmed advanced silicosis patients (4.7±3.07 ng/ml) followed by moderately exposed workers (10.2±1.77 ng/ml) as compared to healthy non-exposed individuals (16.7±3.81 ng/ml). Tobacco smoking also caused a significant decrease of serum CC16 concentration in both healthy (10.2±1.12 ng/ml) and advanced silicosis workers (2.6±2.28 ng/ml) compared to non-smokers. Sensitivity and specificity of CC16 values were also found to be ≥83 per cent for screening all categories of individuals. INTERPRETATION & CONCLUSIONS Because of high sensitivity and specificity, serum CC16 could be used as predictive biomarker for suspicion and early detection of silicosis, which would help in reducing/delaying premature deaths caused by silicosis. It would also control silicotuberculosis additionally.
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Affiliation(s)
- Nibedita Naha
- Division of Biochemistry, ICMR-National Institute of Occupational Health, Ahmedabad, Gujarat, India
| | - Jaseer C.J. Muhamed
- Division of Biochemistry, ICMR-National Institute of Occupational Health, Ahmedabad, Gujarat, India
| | - Avinash Pagdhune
- Division of Biochemistry, ICMR-National Institute of Occupational Health, Ahmedabad, Gujarat, India
| | - Bidisa Sarkar
- Department of General Medicine, KPC Medical College & Hospital, Kolkata, West Bengal, India
| | - Kamalesh Sarkar
- ICMR-National Institute of Occupational Health, Ahmedabad, Gujarat, India
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