Evaluation Of Diagnostic Tests Research Articles

Evaluation of a rapid diagnostic test for detection of Vibrio cholerae O1 in the Democratic Republic of the Congo: Preventative intervention for cholera for 7 days (PICHA7 program).

Globally, there are estimated to be 2.9 million cholera cases annually. Early detection of cholera outbreaks is crucial for resource allocation for case management and for targeted interventions to be delivered to stop the spread of cholera. In resource limited settings such as Eastern Democratic Republic of the Congo (DRC), there is often limited laboratory capacity for analysing stool samples for cholera by bacterial culture. Therefore, rapid diagnostic tests (RDTs) for cholera present a promising tool to rapidly test stool samples in a health facility setting for cholera. Our objective is to evaluate the Crystal VC O1 RDT for cholera detection compared with bacterial culture and polymerase chain reaction (PCR) for Vibrio cholerae. From March 2020 to December 2022, stool samples were collected from 644 diarrhoea patients admitted to 94 health facilities in Bukavu in Eastern DRC. Patient stool samples were analysed by Crystal VC O1 RDT for cholera and by bacterial culture and PCR for V. cholerae O1. Twenty six percent of diarrhoea patients (166/644) had stool samples positive for cholera by RDT, and 24% (152/644) had stool samples positive for V. cholerae O1 by bacterial culture or PCR. The overall specificity and sensitivity of the Crystal VC O1 RDT by direct testing was 94% (95% confidence interval [CI]: 92%-96%) and 90% (95% CI, 84%-94%), respectively, when compared with either a positive result by bacterial culture or PCR. Our findings suggest that the Crystal VC O1 RDT presents a promising tool for cholera surveillance in this cholera endemic setting in sub-Saharan Africa.

Comparative evaluation of RT-PCR and antigen-based rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 detection: performance, variant specificity, and clinical implications.

The COVID-19 pandemic has highlighted the critical need for accurate and efficient diagnostic tools for detecting severe acute respiratory coronavirus 2 (SARS-CoV-2) infections. This study presents a comparison of two diagnostic tests: RT-PCR and antigen detection rapid diagnostic tests (Ag-RDTs). This study focused on their performance, variant specificity, and their clinical implications. A simultaneous testing of 268 samples was carried out for SARS-CoV-2 using RT-PCR and Ag-RDTs [flourescence immunoassay (FIA) and lateral flow immunoassay (LFIA)]. Viral load was quantified, and variant identification was performed using a PCR-based assay. The prevalence was found to be 30.2% using reverse transcription PCR (RT-PCR), 26.5% using FIA, and 25% using LFIA. When comparing the FIA and LFIA, the overall diagnostic performance was found to be 80.25% vs 76.54%, 96.79% vs 97.33%, 91.55% vs 90.51%, and 91.88% vs 92.56% for sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), respectively. Both Ag-RDTs showed a strong agreement with RT-PCR (κ = 0.78-0.80). The overall accuracies of the FIA and LFIA were 92.41% and 92.13%, respectively. The FIA showed higher sensitivity (73.68%) and PPV (92.08%) than the LFIA (65.79% and 90.56%, respectively) in asymptomatic patients. At low Ct values (<25), both Ag-RDTs had 100% sensitivity, but the sensitivity reduced to 31.82% for FIA and 27.27% for LFIA at Ct values > 30. The diagnostic sensitivity of FIA compared to LFIA for detecting the Alpha variant was 78.85% vs. 69.23% and 72.22% vs. 83.33% for the Delta variant. Both Ag-RDTs had 100% sensitivity for detecting Omicron. Both Ag-RDTs performed well in patients with high viral loads and Omicron variant infections compared to those infected with Alpha and Delta variants. This study confirms the comparable performance of RT-PCR and Ag-RDTs, specifically FIA and LFIA, for SARS-CoV-2 detection. The FIA showed higher sensitivity and PPV in asymptomatic cases, while both Ag-RDTs exhibited strong agreement with RT-PCR results. Notably, Ag-RDTs, particularly FIA, proved effective in detecting the Omicron variant and cases with high viral loads, highlighting their potential clinical utility in managing the COVID-19 pandemic.IMPORTANCEThis study is of utmost importance in providing effective responses to manage the COVID-19 pandemic. It rigorously compares the diagnostic accuracy, variant specificity, and practical considerations of reverse transcription PCR (RT-PCR) and antigen detection rapid diagnostic tests (Ag-RDTs) for severe acute respiratory coronavirus 2 (SARS-CoV-2), answering critical questions. The results of this study will help healthcare professionals choose the appropriate testing methods, allocate resources effectively, and enhance public health strategies. Given the evolution of the virus, understanding the performance of these diagnostic tools is crucial to adapting to emerging variants. Additionally, the study provides insights into logistical challenges and accessibility issues, which will contribute to refining testing workflows, particularly in resource-limited settings. Ultimately, the study's impact extends to global healthcare, providing valuable information for policymakers, clinicians, and public health officials as they work together for mitigating the impact of the pandemic.

CT-like images based on T1-weighted gradient echo MRI sequences for the assessment of fractures of the hand and wrist compared to CT.

To evaluate the performance of a 3D T1-weighted gradient-echo (3D T1GRE) computed tomography (CT)-like magnetic resonance imaging (MRI) sequence for detecting and assessing wrist and hand fractures compared to conventional CT. Subjects with acute wrist or hand fracture in CT underwent additional 3T MRI including a CT-like 3D T1GRE sequence and were compared to patients without fractures. Two radiologists assessed fracture morphology on both modalities according to the Arbeitsgemeinschaft Osteosynthese (AO) and graded image quality and diagnostic confidence on a 5-point Likert scale. Besides diagnostic test evaluation, differences in image quality and diagnostic confidence between CT-like MRI and CT were calculated using the Wilcoxon test. Agreement of AO classification between modalities and readers was assessed using Cohen's Kappa. Twenty-eight patients with 43 fractures and 43 controls were included. Image quality (3D T1GRE 1.19 ± 0.37 vs. CT 1.22 ± 0.42; p = 0.65) and diagnostic confidence (3D T1GRE 1.28 ± 0.53 vs. CT 1.28 ± 0.55; p = 1.00) were rated excellent for both modalities. Regarding the AO classification, intra- (rater 1 and rater 2, κ = 0.89; 95% CI 0.80-0.97) and interrater agreement were excellent (3D T1GRE, κ = 0.82; 95% CI, 0.70-0.93; CT, κ = 0.85; 95% CI, 0.75-0.94). CT-like MRI showed excellent sensitivity, specificity and accuracy for fracture detection (reader 1: 1.00, 0.92, 0.96; reader 2: 0.98, 0.94, 0.96). CT-like MRI is a comparable alternative to CT for assessing hand and wrist fractures, offering the advantage of avoiding radiation exposure.

Diagnostic performance of the GGT/HDL-C ratio for NAFLD in adults with obesity undergoing bariatric surgery

BackgroundNon-alcoholic fatty liver disease (NAFLD) has become the most frequent liver disease, closely related with metabolic risk factors such as obesity, insulin resistance, dyslipidemia, diabetes mellitus, and metabolic syndrome. In this context, γ-Glutamyl transpeptidase (GGT) and high-density lipoprotein cholesterol (HDL-C) have shown correlations with steatosis severity and metabolic syndrome, respectively. This positions the GGT/HDL-C ratio as a potential diagnostic indicator for NAFLD. ObjectiveTo assess the diagnostic performance of the GGT/HDL-C ratio for NAFLD in adults with obesity undergoing bariatric surgery. MethodsWe conducted an analytical cross-sectional study, designed as a diagnostic test evaluation. A secondary database of 249 adults with obesity was analyzed. The optimal cut-off point was ascertained using three methodologies, and five adjustment models were constructed for the total population, further stratified by sex. ResultsThe optimal cut-off point was 20.5 U/mmol and the AUC of the ratio was 0.81 (95% CI: 0.64–0.98), with sensitivity and specificity being 82.5% and 77.8%, respectively. In the overall group with an elevated GGT/HDL-C ratio, the prevalence of NAFLD increased by 14% (PR: 1.14; 95% CI: 1.04–1.33). Specifically, women displaying this altered ratio showed a 19% increased prevalence (PR: 1.19; 95% CI: 1.07–1.42) compared to those with normal values. ConclusionsThe GGT/HDL-C ratio is a promising biomarker for the diagnosis of NAFLD in an adult population living with obesity.

Laboratory evaluation of a rapid diagnostic test for dairy mastitis.

Rapid diagnostic tests that differentiate between Gram positive, Gram negative and the absence of aerobic bacteria in milk samples from dairy cows with clinical mastitis can support antimicrobial treatment decisions and contribute to a more prudent use of antimicrobials in the dairy industry. The objective of this study was to evaluate the test characteristics of the novel rapid BACT mastitis test in discriminating causes of clinical mastitis under laboratory conditions. Test outcomes of 155 milk samples from clinical mastitis cases were incubated for 14-16 h in the BACT test and compared to results of bacteriological culture. The accuracy for detection of bacterial growth and Gram positive growth was 91 and 89%, respectively. The BACT test could provide an accurate and relatively fast decision tool for farmers to aid in antimicrobial treatment decisions in cases of clinical mastitis.

Evaluation of Diagnostic and Screening Test in Veterinary Medicine

Evaluation of Diagnostic and Screening Test in Veterinary Medicine

Evaluation of COVID-19 antigen rapid diagnostic tests for self-testing in Lesotho and Zambia.

The use of antigen rapid tests (Ag-RDTs) for self-testing is an important element of the COVID-19 control strategy and has been widely supported. However, scale-up of self-testing for COVID-19 in sub-Saharan Africa is still insufficient and there is limited evidence on the acceptability of self-testing and agreement between Ag-RDT self-testing and Ag-RDT testing by professional users. A joint collaboration (Botnar Research Centre for Child Health-European & Developing countries Clinical Trials Partnership)was established between Lesotho and Zambia to address these gaps in relation to Ag-RDT self-testing and contribute to increasing its use in the region. A cross-sectional study was conducted with qualitative and quantitative data analysis. Firstly, 14 in-depth cognitive interviews (5 in Zambia and 9 in Lesotho) were performed to assess the participants' understanding of the instructions for use (IFU) for self-testing. In a second step, evaluation of test agreement between Ag-RDT self-testing and Ag-RDT testing by professional user using SD Biosensor STANDARD Q COVID-19 Ag-RDT was performed. In Zambia, usability and acceptability of self-testing were also assessed. Cognitive interviews in Lesotho and Zambia showed overall good understanding of IFU. In Zambia, acceptability of self-testing was high, though some participants had difficulties in conducting certain steps in the IFU correctly. Agreement between Ag-RDT self-test and Ag-RDT by professional users in Lesotho (428 participants) and Zambia (1136 participants) was high, 97.3% (403/414, 95% CI: 95.3-98.7) and 99.8% (1116/1118, 95% CI: 99.4-100) respectively. Findings from this study support the use of Ag-RDT self-testing within COVID-19 control strategies in sub-Saharan Africa, contributing to increase the testing capacity and access in hard-to reach settings.

A User-friendly Approach for the Diagnosis of Diabetic Retinopathy Using ChatGPT and Automated Machine Learning

To assess the capabilities of Chat Generative Pre-trained Transformer (ChatGPT) and Vertex AI in executing code-free preprocessing, training machine learning (ML) models, and analyzing the data. Evaluation of diagnostic test or technology. ChatGPT and Vetrex AI as publicly available large language model and ML platform, respectively. ChatGPT was employed to improve the resolution of fundus photography images from the Methods to Evaluate Segmentation and Indexing Techniques in the field of Retinal Ophthalmology (Messidor-2) open-source dataset using the Contrast Limited Adaptive Histogram Equalization (CLAHE) technique by Fiji software. Subsequently, Vertex AI, an automated ML (AutoML) platform, was utilized to develop 2 classification models. The first model served as a binary classifier for detecting the presence of diabetic retinopathy (DR), while the second determined its severity. Finally, ChatGPT was used to provide scripts for R and Python programming languages for data analysis and was also directly employed in analyzing the data in a code-free method. Evaluating the utility of ChatGPT in generating scripts for preprocessing images using Fiji and analyzing data across Python and R and assessing its potential in analyzing data through a code-free method. Investigating the capabilities of Vertex AI to train image classification models for detection of DR and its severity. Two ML models were trained using 1740 images from the Messidor-2 database. The first model, designed to detect the severity of DR, achieved an area under the precision-recall curve (AUPRC) of 0.81, with a precision rate of 81.81% and recall of 72.83%. The second model, tailored for the detection of the presence of DR, recorded a precision and recall of 84.48% with an AUPRC of 0.90. ChatGPT and Vertex AI have the potential to enable physicians without coding expertise to preprocess images, analyze data, and train ML models. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Determination of Ideal Factors for Early Adoption and Standardization of Metagenomic Next-Generation Sequencing for Respiratory System Infections.

Metagenomic next-generation sequencing (mNGS) demonstrates great promise as a diagnostic tool for determining the cause of pathogenic infections. The standard diagnostic procedures (SDP) include smears and cultures and are typically viewed as less sensitive and more time-consuming when compared to mNGS. There are concerns about the logistics and ease of transition from SDP to mNGS. mNGS lacks standardization of collection processes, databases, and sequencing. Additionally, there is the burden of training clinicians on interpreting mNGS results. Until now, few studies have explored factors that could be used as early adoption candidates to ease the transition between SDP and mNGS. This study evaluated 123 patients who had received both SDP and mNGS and compared several variables across a diagnostic test evaluation. The diagnostic test evaluation observed metrics such as sensitivity, specificity, positive and negative likelihood ratios (PLR, NLR), positive and negative predictive values (PPV, NPV), and accuracy. Factors included various sample sources such as bronchoalveolar lavage fluid (BALF), lung tissue, and cerebral spinal fluid (CSF). An additional factor observed was the patient's immune status. Pathogen detection was found to be significantly greater for mNGS for total patients, BALF sample source, CSF sample source, and non-immunocompromised patients (p<0.05). Pathogen detection was found to be insignificant for lung tissue sample sources and immunocompromised patients. Sensitivity, PLR, NLR, PPV, NPV, and accuracy appeared to be higher with mNGS for the total patients, BALF sample source, and non-immunocompromised patients when compared with SDP (p<0.05). With higher metrics in sensitivity, specificity, PLR, NLR, PPV, NPV, and accuracy for overall patients, mNGS may prove a better diagnostic tool than SDP. When addressing sample sources, mNGS for BALF-collected samples appeared to have higher scores than SDP for the same metrics. When patients were in a non-immunocompromised state, mNGS also demonstrated greater diagnostic benefits to BALF and overall patients compared to SDP. This study demonstrates that using BALF as a sample source and selecting non-immunocompromised patients may prove beneficial as early adoption factors for mNGS standard protocol. Such a study may pave the road for mNGS as a routine clinical method for determining the exact pathogenic etiology of lung infections.

Evidence Synthesis and Linkage for Modelling the Cost-Effectiveness of Diagnostic Tests: Preliminary Good Practice Recommendations.

To develop preliminary good practice recommendations for synthesising and linking evidence of treatment effectiveness when modelling the cost-effectiveness of diagnostic tests. We conducted a targeted review of guidance from key Health Technology Assessment (HTA) bodies to summarise current recommendations on synthesis and linkage of treatment effectiveness evidence within economic evaluations of diagnostic tests. We then focused on a specific case study, the cost-effectiveness of troponin for the diagnosis of myocardial infarction, and reviewed the approach taken to synthesise and link treatment effectiveness evidence in different modelling studies. The Australian and UK HTA bodies provided advice for synthesising and linking treatment effectiveness in diagnostic models, acknowledging that linking test results to treatment options and their outcomes is common. Across all reviewed models for the case study, uniform test-directed treatment decision making was assumed, i.e., all those who tested positive were treated. Treatment outcome data from a variety of sources, including expert opinion, were utilised for linked clinical outcomes. Preliminary good practice recommendations for data identification, integration and description are proposed. Modelling the cost-effectiveness of diagnostic tests poses unique challenges in linking evidence on test accuracy to treatment effectiveness data to understand how a test impacts patient outcomes and costs. Upfront consideration of how a test and its results will likely be incorporated into patient diagnostic pathways is key to exploring the optimal design of such models. We propose some preliminary good practice recommendations to improve the quality of cost-effectiveness evaluations of diagnostics tests going forward.

Local anesthetics allergy in children: Evaluation of diagnostic tests with Real-Life data.

Local anesthetic (LA) drugs are commonly used in clinical practice to provide effective analgesia, including in dentistry and minor surgical procedures. The perception of a high risk of allergy in daily applications leads to the referral of atopic patients and those with other drug allergies to allergy clinics for the evaluation of allergic reactions to LA. The aim of this study was to determine who should be referred to the allergy clinic for LA allergy testing, assess the frequency of LA allergy in pediatric patients, and identify the negative predictive value of skin tests in diagnosis. January 2017-July 2023, the clinical and laboratory data, as well as the results of drug allergy tests, of patients referred to our pediatric allergy clinic by dentists and physicians performing minor surgical procedures with suspected LA allergy were retrospectively evaluated. Our study included a total of 153 patients, comprising 84 girls (54.9%) and 69 boys (45.1%), with a mean age of 8.9 (±3.3) years. The most common reason for referral was a history of non-LA drug allergies (n = 66, 43.2%), followed by asthma (n = 25, 16.3%). Hypersensitivity reactions (HRs) with LA were most commonly associated with articaine (n = 7, 4.8%), followed by lidocaine (n = 6, 4.1%). When intradermal tests were evaluated, 17 patients (11.1%) had a positive test result. The positivity for lidocaine was 70.6% (n = 12), and prilocaine was 29.4% (n = 5). Subcutaneous provocation was administered to 109 patients (71.2%), and one patient exhibited local erythema and swelling with prilocaine. Although LA allergy is a rare occurrence, consultations of this nature are frequently requested from allergy clinics in real life. Considering the negative predictive value of skin tests performed with LA drugs, the reaction rate appears to be low in patients with atopy or other drug allergies. It is crucial for all relevant healthcare professionals to be knowledgeable about the appropriate approach to suspected LA allergies to avoid unnecessary tests. To the best of our knowledge, our study is the most comprehensive work in the literature that evaluates the results of diagnostic tests in children referred with a suspicion of LA allergy.

Evaluation of molecular diagnostic test for detection of adult pulmonary tuberculosis: A generic protocol.

Tuberculosis (TB) continues to be the second most-leading cause of death due to a single infectious agent as of 2022 after COVID-19. Many affordable new molecular diagnostic tools are being developed for early and more accurate diagnosis, especially for low-resource settings in low- and middle-income countries. In this context, there is a need to develop a standardized protocol for validation of new diagnostic tools. Here, we describe a generic protocol for multi-centric clinical evaluation of molecular diagnostic tests for adult pulmonary TB. This protocol describes a cross-sectional study in TB reference laboratories in India. Adults (>18 yr) visitng the chest clinics or outpatient departments with symptoms of TB need to be enrolled consecutively till the required sample size of 150 culture positives and 470 culture negatives are met. Mycobacterium tuberculosis (Mtb) culture (mycobacteria growth indicator tube liquid culture) to be used under this protocol as the gold standard and Xpert MTB/RIF molecular test will be used as the comparator. The sputum samples will be tested by smear microscopy, Mtb culture, Xpert MTB/RIF and index molecular test as per the proposed algorithm. The specificity sensitivity, and positive/ negative predictive values are to be calculated for the index test with reference to the gold standard. TB diagnosis poses many challenges as it differs with type of disease, age group, clinical settings and type of diagnostic tests/kits used. Globally, different protocols are used by several investigators. This protocol provides standard methods for the validation of molecular tests for diagnosis of adult pulmonary TB, which can be adopted by investigators.

The Evaluation of Invasive Prenatal Diagnostic Tests in North Cyprus: A Retrospective Study.

Congenital diseases are still an important medical, social, and economic problem all over the world. In North Cyprus, in addition to other reasons, early prenatal diagnostic measures are undertaken to prevent births with thalassemia major, a locally widespread genetic disease. This study aims to evaluate the results of prenatal invasive diagnostic tests performed in a private obstetrics clinic in Northern Cyprus and show the diagnosis process of thalassemia and chromosomal anomalies. This study is a retrospective, descriptive study. Chorionic villus sampling (CVS) results and the amniocentesis tests performed between 1990 and 2022 are evaluated. Thalassemia and chromosome analysis of samples obtained by CVS and amniocentesis tests were performed. To diagnose alpha or beta thalassemia and sickle cell, 239 CVS was performed. And to diagnose chromosomal anomalies, 396 CVS and amniocentesis were performed. The mean age of the 480 pregnant women included in the study was 31.12 years (18-46) and 30% of them were older than 34 years. The most common indications for invasive prenatal diagnostic test (IPDT) were; mother/father thalassemia minor/major, advanced maternal age, high risk of ultrasonography erase findings, and the noninvasive screening test. The result of IPDT detected 7.3% chromosomal anomaly and 69.5% thalassemia and sickle cell anemia. Of the 239 CVS performed to diagnose alpha or beta thalasemia and sickle cell, 23.4% beta major, 42.3% beta minor, and 2.1% alpha minor were diagnosed. Of the 396 CVS and amniocentesis performed to diagnose chromosomal anormalies; 2.8% of Down syndrome and 4.54% of other chromosomal anomalies were diagnosed. IPDT is important in correctly diagnosing fetal anomalies at the prenatal stage to help families decide at the right time.

Multiplex PCR test as an intra-operative diagnostic tool for periprosthetic joint infection in presumed aseptic revision hip and knee arthroplasty: a 1-year follow-up study of 200 cases.

Automated custom-made multiplex PCR techniques (mPCR) have become commercially available and are designed for intra-operative screening of concurrent periprosthetic joint infections (PJIs). The purpose of this study was to evaluate the value of a positive mPCR test in presumed aseptic revision total hip (THA) and knee (TKA) arthroplasties after a 1-year follow-up. In an earlier study, such an automated mPCR technique (Unyvero ITI G2; Curetis, Holzgerlingen, Germany) was tested on intra-operatively obtained synovial fluid in 200 patients with a presumed aseptic TKA or THA revision. At the time of revision, no therapeutic consequences were attached to a positive test result since treating personnel were blinded for the test results. We retrospectively reviewed the outcome of cases with respect to the occurrence of PJIs using the European Bone and Joint Infection Society (EBJIS) criteria during a 1-year follow-up postoperatively. A total of 10 out of 200patients had a positive mPCR test result at the time of revision. Of these 10 cases, none encountered outcome parameters fulfilling the criteria to diagnose PJIs in the first year after surgery, and one required re-revision surgery for reasons other than infection. Of the other 190 negative mPCR cases, none developed a PJI. A positive mPCR test at the time of presumed aseptic revision surgery did not correspond with intra-operatively obtained tissue cultures, and none of the encountered positive mPCR tests had developed a PJI at the 1-year follow-up. We recommend careful evaluation and monitoring of modern diagnostic tests before widespread use.

Effect of magnetic resonance imaging in liver metastases

This letter to the editor is a commentary on a study titled "Liver metastases: The role of magnetic resonance imaging." Exploring a noninvasive imaging evaluation system for the biological behavior of hepatocellular carcinoma (HCC) is the key to achieving precise diagnosis and treatment and improving prognosis. This review summarizes the role of magnetic resonance imaging in the detection and evaluation of liver metastases, describes its main imaging features, and focuses on the added value of the latest imaging tools (such as T1 weighted in phase imaging, T1 weighted out of phase imaging; diffusion-weighted imaging, T2 weighted imaging). In this study, I investigated the necessity and benefits of gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for HCC diagnostic testing and prognostic evaluation.

FDrisk: development of a validated risk assessment tool for Fabry disease utilizing electronic health record data

PurposeFabry disease (FD) is a rare, X-linked, lysosomal storage disease characterized by great variability in clinical presentation and progressive multisystemic organ damage. Lack of awareness of FD and frequent misdiagnoses cause long diagnostic delays. To address the urgent need for earlier diagnosis, we created an online, risk-assessment scoring tool, the FDrisk, for predicting an individual’s risk for FD and prompting diagnostic testing and clinical evaluation.MethodsUtilizing electronic health records, data were collected retrospectively from randomly selected, deidentified patients with FD treated at the Emory Lysosomal Storage Disease Center. Deidentified, negative controls were randomly selected from the Fabry Disease Diagnostic Testing and Education project database, a program within the American Association of Kidney Patients Center for Patient Education and Research. Diagnosis of FD was documented by evidence of a pathogenic variant in GLA and/or an abnormal level of leukocyte α-Gal A. Thirty characteristic clinical features of FD were initially identified and subsequently curated into 16 clinical covariates used as predictors for the risk of FD. An overall prediction model and two sex-specific prediction models were built. Two-hundred and sixty samples (130 cases, 130 controls) were used to train the risk prediction models. One-hundred and ninety-seven independent samples (30 cases, 167 controls) were used for testing model performance. Prediction accuracy was evaluated using a threshold of 0.5 to determine a predicted case vs. control.ResultsThe overall risk prediction model demonstrated 80% sensitivity, 83.8% specificity, and positive predictive value of 47.1%. The male model demonstrated 75% sensitivity, 95.8% specificity, and positive predictive value of 75%. The female model demonstrated 83.3% sensitivity, 81.3% specificity, and positive predictive value of 45.5%. Patients with risk scores at or above 50% are categorized as “at risk” for FD and should be sent for diagnostic testing.ConclusionWe have developed a statistical risk prediction model, the FDrisk, a validated, clinician-friendly, online, risk-assessment scoring tool for predicting an individual’s risk for FD and prompting diagnostic testing and clinical evaluation. As an easily accessible, user-friendly scoring tool, we believe implementing the FDrisk will significantly decrease the time to diagnosis and allow earlier initiation of FD-specific therapy.

Bayesian diagnostic test evaluation and true prevalence estimation of malnutrition in gastric cancer patients

Malnutrition is prevalent among gastric cancer (GC) patients, necessitating early assessment of nutritional status to guide monitoring and interventions for improved outcomes. We aim to evaluate the accuracy and prognostic capability of three nutritional tools in GC patients, providing insights for clinical implementation. The present study is an analysis of data from 1308 adult GC patients recruited in a multicenter from July 2013 to July 2018. Nutritional status was assessed using Nutritional Risk Screening 2002 (NRS-2002), Patient-Generated Subjective Global Assessment (PG-SGA) and Global Leadership Initiative on Malnutrition (GLIM) criteria. Bayesian latent class model (LCM) estimated the malnutrition prevalence of GC patients, sensitivity and specificity of nutritional tools. Cox regression model analyzed the relationship between nutritional status and overall survival (OS) in GC patients. Among 1308 GC patients, NRS-2002, PG-SGA, and GLIM identified 50.46%, 76.76%, and 68.81% as positive, respectively. Bayesian LCM analysis revealed that PG-SGA had the highest sensitivity (0.96) for malnutrition assessment, followed by GLIM criteria (0.78) and NRS-2002 (0.65). Malnutrition or being at risk of malnutrition were identified as independent prognostic factors for OS. Use any of these tools improved survival prediction in TNM staging system. PG-SGA is the most reliable tool for diagnosing malnutrition in GC patients, whereas NRS-2002 is suitable for nutritional screening in busy clinical practice. Given the lower sensitivity of NRS-2002, direct utilization of GLIM for nutritional assessment may be necessary. Each nutritional tool should be associated with a specific course of action, although further research is needed.

Evaluating the Effectiveness of Triiodothyronine Suppression and Withdrawal Versus Thyrogen Injections in Thyroid Cancer Assessments.

Objective This study aimed to evaluate the specificity and effectiveness of triiodothyronine (T3) suppression and withdrawal, as compared to the conventional diagnostic approach using Thyrogen recombinant thyroid-stimulating hormone (TSH) injections, in the assessment of thyroid cancer patients post-thyroidectomy. Methods In this retrospective study, 18 patients diagnosed with thyroid cancer at a tertiary care hospital (Mediclinic City Hospital) in Dubai were included. The patients underwent total thyroidectomy, iodine ablation, and neck ultrasound. The cohort's clinical characteristics were analyzed, and histopathological examination of thyroid nodules was performed.In this study, paired T-tests were applied to evaluate the before-and-after impact of T3 and Thyrogen treatments on TSHand thyroglobulin (TG) levels in individual patients. To further analyze the effectiveness of these treatments, independent T-tests were conducted, allowing for a comparison of TSH and TG levels between different treatment groups within the patient cohort. This approach provided a comprehensive assessment of the treatments' effects on key thyroid indicators. Additionally, the diagnostic accuracy of T3 withdrawal and Thyrogen post-test on TGlevels was assessed using statistical measures including sensitivity, specificity, and predictive values. Results The cohort had a mean age of 42.1 years and a female predominance. Distinct clinical profiles were observed across different thyroid cancer subtypes. Histopathological analysis confirmed typical features of papillary carcinoma variants. Significant changes in TSHlevels post-treatment were noted, with T3 treatments showing a marked increase in TSH and TGlevels, although changes in TGlevels were not always statistically significant. Diagnostic test evaluation showed a sensitivity of 77.78%, a specificity of 83.33%, and an overall accuracy of 80.00% for T3 withdrawal and Thyrogen post-test on TG. Conclusion The study provides comprehensive insights into the clinical profiles and treatment responses in thyroid cancer patients post-thyroidectomy. The effectiveness of T3 and Thyrogen treatments in altering TSHand TGlevels was established, with significant implications for patient management. The diagnostic tests for T3 withdrawal and Thyrogen post-test on TGdemonstrated high accuracy, underlining their clinical utility in the post-treatment evaluation of thyroid cancer patients.

High Specificity but Low Sensitivity of Lab-on-a-Disk Technique in Detecting Soil-Transmitted Helminth Eggs among Pre- and School-Aged Children in North-Western Tanzania.

An estimated 1.5 billion people are infected with soil-transmitted helminths (hookworms, Ascaris lumbricoides and Trichuris trichiura). These infections are targeted for elimination by the World Health Organization (WHO) by 2030, with the main interventions being mass drug administration using albendazole or mebendazole. Tanzania is one of the endemic countries; it has been implementing MDA to school-aged children for more than a decade and the infection prevalence and intensity of infection have declined. Thus, at this point, the monitoring and evaluation of infection prevalence and intensity of infections, and assessing drug efficacy is crucial and requires accurate diagnostic tests. The currently used standard diagnostic test, the Kato-Katz (KK) technique, has several limitations and the WHO is calling for the development and evaluation of new diagnostic tests. The Lab-on-a-disk (LOD) was developed and tested in the endemic areas of north-western Tanzania to evaluate its sensitivity and specificity using KK and the formol-ether concentration technique. The results showed that when using a duplicate KK slide, the LOD had a sensitivity and specificity of 37.2% (95% CI: 30.7-43.9) and 67.3% (95% CI: 63.1-71.3%). Using four KK slides as a standard technique, the overall sensitivity and specificity were 37.7% (95% CI: 33.1-42.6) and 70.7% (95% CI: 65.5-75.6). The LOD attained high specificity but low sensitivity especially in detecting eggs of Trichuris trichiura. The LOD technique has potential as a promising diagnostic test, but its sensitivity still requires improvement.

Predicting Waist Circumference From a Single Computed Tomography Image Using a Mobile App (Measure It): Development and Evaluation Study.

Despite the existing evidence that waist circumference (WC) provides independent and additive information to BMI when predicting morbidity and mortality, this measurement is not routinely obtained in clinical practice. Using computed tomography (CT) scan images, mobile health (mHealth) has the potential to make this abdominal obesity parameter easily available even in retrospective studies. This study aimed to develop a mobile app as a tool for facilitating the measurement of WC based on a cross-sectional CT image. The development process included three stages: determination of the principles of WC measurement from CT images, app prototype design, and validation. We performed a preliminary validity study in which we compared WC measurements obtained both by the conventional method using a tape measurement in a standing position and by the mobile app using the last abdominal CT slice not showing the iliac bone. Pearson correlation, student t tests, and Q-Q and Bland-Altman plots were used for statistical analysis. Moreover, to perform a diagnostic test evaluation, we also analyzed the accuracy of the app in detecting abdominal obesity. We developed a prototype of the app Measure It, which is capable of estimating WC from a single cross-sectional CT image. We used an estimation based on an ellipse formula adjusted to the gender of the patient. The validity study included 20 patients (10 men and 10 women). There was a good correlation between both measurements (Pearson R=0.906). The student t test showed no significant differences between the two measurements (P=.98). Both the Q-Q dispersion plot and Bland-Altman analysis graphs showed good overlap with some dispersion of extreme values. The diagnostic test evaluation showed an accuracy of 83% when using the mobile app to detect abdominal obesity. This app is a simple and accessible mHealth tool to routinely measure WC as a valuable obesity indicator in clinical and research practice. A usability and validity evaluation among medical teams will be the next step before its use in clinical trials and multicentric studies.