Diagnostic Test Accuracy Research Articles

Diagnostic accuracy of serological and imaging tests used in surveillance for hepatocellular carcinoma in adults with cirrhosis: a systematic review protocol.

Liver cirrhosis is the largest risk factor for developing hepatocellular carcinoma (HCC), and surveillance is therefore recommended among this population. Current guidance recommends surveillance with ultrasound, with or without alpha-fetoprotein (AFP). This review is part of a larger project looking at benefits, harms and costs of surveillance for HCC in people with cirrhosis. It aims to synthesise the evidence on the diagnostic accuracy of imaging or biomarker tests, alone or in combination, to identify HCC in adults with liver cirrhosis in a surveillance programme. We will identify studies through a 2021 Cochrane review with similar eligibility criteria, and a database search of MEDLINE, Embase and the Cochrane Database of Systematic Reviews. We will include diagnostic test accuracy studies with adult cirrhosis patients of any aetiology. Studies must assess at least one of the following index tests: ultrasound (US), magnetic resonance imaging (MRI), computerised tomography (CT), alpha-fetoprotein (AFP), des-gamma-carboxyprothrombin (DCP), lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), a genomic biomarker, or a diagnostic prediction model incorporating at least one of the above-mentioned tests. We will assess studies for risk of bias using QUADAS-2 and QUADAS-C. We will combine data using bivariate random effects meta-analyses. For tests evaluated across varying diagnostic thresholds, we will produce pooled estimates of sensitivity and specificity across the full range of numerical thresholds, where possible. Where sufficient studies compare two or more index tests, we will perform additional analyses to compare the accuracy of different tests. Where feasible, we will stratify all meta-analyses by tumour size and patient characteristics, including cirrhosis aetiology and liver disease severity. This review will synthesise evidence across the full range of possible surveillance tests, using advanced statistical methods to summarise accuracy across all thresholds and to compare the accuracy of different tests. CRD42022357163.

The International System for Reporting Serous Fluid Cytopathology: A Systematic Review and Meta-Analysis of Diagnostic Test Accuracy Studies.

This is the first systematic review and meta-analysis of The International System (TIS) for reporting serous fluid cytopathology. Our aims were to present the pooled malignancy rate of each TIS reporting category and the diagnostic accuracy of cytology using this system. Database search using a predefined strategy was followed by study selection, data extraction, study quality assessment, and statistical analysis. Data derived from 16 eligible studies were pooled. The pooled rates of malignancy were as follows: 27% (95% CI; 16%-41%) for "nondiagnostic" (ND), 11% (95% CI; 7%-18%) for negative for malignancy" (NFM), 49% (95% CI; 37%-61%) for "atypia of undetermined significance" (AUS), 90% (95% CI; 81%-95%) for "suspicious for malignancy" (SFM), and 100% (95% CI; 98%-100%) for "positive for malignancy" (MAL). Studies performed exclusively in cancer hospitals showed higher pooled malignancy rates, compared with academic and community hospitals serving the general population, in the ND [40% (95% CI; 21%-62%) vs. 22% (95% CI; 11%-39%)], NFM [20% (95% CI; 13%-30%) vs. 9% (95% CI; 5%-17%)], and AUS categories [55% (95% CI; 47%-63%) vs. 46% (95% CI; 31%-62%)]. Notably, the difference was significant in the NFM category (P=0.04). When both SFM and MAL cytology interpretations were considered as malignant outcomes, the pooled sensitivity and specificity were 68.74% (95% CI; 59.90%-76.39%) and 98.81% (95% CI; 98.18%-99.22%), respectively. In addition, the diagnostic odds ratio (DOR) was found to be 170.7 (95% CI; 96.2-303.3). Despite its strengths, our study also had some limitations. Therefore, future large-scale longitudinal studies could strengthen the findings of this review.

A systematic review and meta-analysis of diagnostic test accuracy of chest ultrasound in diagnosing pediatric pulmonary tuberculosis.

Despite medical advancement, pediatric pulmonary tuberculosis (PTB) still has high morbidity and mortality, due to challenging detection in clinical practice. Ultrasound has been touted as the next best diagnostic tool but currently, this claim is unfounded. Therefore, this study aims to systematically review the diagnostic parameters of chest ultrasound in diagnosing pediatric PTB. The literature search started and ended on December 23, 2023. We searched MEDLINE, Cochrane Library, Pubmed, Science Direct, and Google Scholar. Our research question could be formulated as "In pediatric patients who present with signs and symptoms of PTB such as fever, cough, and poor weight gain, how accurate is chest ultrasound in ruling in and ruling out pediatric PTB when the diagnosis is compared to culture, PCR or CXR?" This systematic review adhered to the PRISMA-DTA guidelines while the meta-analysis was conducted with STATA program using the "midas" and "metandi" commands. There are five studies included with 137 positive PTB children. The combined sensitivity is 84% (95% confidence interval [CI]: 76-89), specificity of 38% (95% CI: 24-54), and summary receiver operating curve yields an area under the curve of 0.83 (95% CI: 0.80-0.86). The I2 value is 24% (95% CI: 0-100) with a p-value of 0.13. The combined negative predictive value is 0.68 (95% CI: 0.58-0.79), and the positive predictive value is 0.57 (95% CI: 0.51-0.63). The positive likelihood ratio is 1 with a 6% increase from the baseline while the negative likelihood ratio is 0.43 with a 12% decrease from the baseline. Chest ultrasound is sensitive but currently could neither exclude nor confirm pediatric PTB.

Diagnostic accuracy of lever sign test in acute and chronic ACL injuries

IntroductionThe anterior cruciate ligament (ACL) is a commonly affected knee ligament prone to frequent injuries. Henceforth, we aimed to determine the diagnostic accuracy of lever sign test in Acute and chronic ACL injuries. MethodAt the institution's initial outpatient visit, 150 consecutive patients (92 males and 58 females) were evaluated. Total 108 patients had injury in their right leg, whereas 42 had injury in their left leg. Based on time since injury, the patients were divided into Acute and chronic groups. Clinical examinations (lachman's test and lelli's test) of all patients were confirmed with arthroscopic findings and compared between the two groups. ResultsIn the acute ACL injury, the lever test had a kappa value 0.704. The accuracy and sensitivity of the Lachman, anterior drawer, pivot shift, and lever tests were calculated. We found that the lever test had the highest accuracy and sensitivity (85.48 %, 91.18 %) than the rest. In the chronic ACL injury, the kappa value for the results of the Lachman test evaluation was 0.723. The chronic ACL injuries accuracy and sensitivity values for the Lachman (86.36 %, 91.67 %), anterior drawer (76.14 %, 81.25 %), pivot shift (55.68 %, 58.49 %), and lever tests were determined. ConclusionThe lever sign test is more accurate and reliable in the acute ACL injuries, while the Lachman test is more accurate and reliable in the chronic ACL injuries.

Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease: protocol for the Nordic inception cohort study (NORDTREAT)

IntroductionInflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease, can be challenging to diagnose, and treatment outcomes are difficult to predict. In the NORDTREAT cohort study, a Nordic prospective...

The 4AT, a rapid delirium detection tool for use in hospice inpatient units: Findings from a validation study

Background: Delirium is a serious neuropsychiatric syndrome with adverse outcomes, which is common but often undiagnosed in terminally ill people. The 4 ‘A’s test or 4AT (www.the4AT.com), a brief delirium detection tool, is widely used in general settings, but validation studies in terminally ill people are lacking. Aim: To determine the diagnostic accuracy of the 4AT in detecting delirium in terminally ill people, who are hospice inpatients. Design: A diagnostic test accuracy study in which participants underwent the 4AT and a reference standard based on the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders. The reference standard was informed by Delirium Rating Scale Revised-98 and tests assessing arousal and attention. Assessments were conducted in random order by pairs of independent raters, blinded to the results of the other assessment. Setting/participants: Two hospice inpatient units in Scotland, UK. Participants were 148 hospice inpatients aged ⩾18 years. Results: A total of 137 participants completed both assessments. Three participants had an indeterminate reference standard diagnosis and were excluded, yielding a final sample of 134. Mean age was 70.3 (SD = 10.6) years. About 33% (44/134) had reference standard delirium. The 4AT had a sensitivity of 89% (95% CI 79%–98%) and a specificity of 94% (95% CI 90%–99%). The area under the receiver operating characteristic curve was 0.97 (95% CI 0.94–1). Conclusion: The results of this validation study support use of the 4AT as a delirium detection tool in hospice inpatients, and add to the literature evaluating methods of delirium detection in palliative care settings. Trial registry: ISCRTN 97417474.

Development of a decision support tool to compare diagnostic strategies for establishing the herd status for infectious diseases: An example with Salmonella Dublin infection in dairies

The diagnosis of infectious diseases at herd level can be challenging as different stakeholders can have conflicting priorities. The current study proposes a “proof of concept” of an approach that considers a reasonable number of criteria to rank plausible diagnostic strategies using multi-criteria decision analysis (MCDA) methods. The example of Salmonella Dublin diagnostic in Québec dairy herds is presented according to two epidemiological contexts: (i) in herds with no history of S. Dublin infection and absence of clinical signs, (ii) in herds with a previous history of infection, but absence of clinical signs at the moment of testing. Multiple multiparty exchanges were conducted to determine: 1) stakeholders’ groups; 2) the decision problem; 3) solutions to the problem (options) or diagnostic strategies to be ordered; 4) criteria and indicators; 5) criteria weights; 6) the construction of a performance matrix for each option; 7) the multi-criteria analyses using the visual preference ranking organization method for enrichment of evaluations approach; 8) the sensitivity analyses, and 9) the final decision. A total of nine people from four Québec’s organizations (the dairy producers provincial association along with the DHI company, the ministry of agriculture, the association of veterinary practitioners, and experts in epidemiology) composed the MCDA team. The decision problem was “What is the optimal diagnostic strategy for establishing the status of a dairy herd for S. Dublin infection when there are no clinical signs of infection?”. Fourteen diagnostic strategies composed of the three following parameters were considered: 1) biological samples (bulk tank milk or blood from 10 heifers aged over three months); 2) sampling frequencies (one to three samples collection visits); 3) case definitions to conclude to a positive status using imperfect milk- or blood-ELISA tests. The top-ranking diagnostic strategy was the same in the two contexts: testing the bulk tank milk and the blood samples, all samples collected during one visit and the herd being assigned a S. Dublin positive status if one sample is ELISA-positive. The final decision favored the top-ranking option for both contexts. This MCDA approach and its application to S. Dublin infection in dairy herds allowed a consensual, rational, and transparent ranking of feasible diagnostic strategies while taking into account the diagnostic tests accuracy, socio-economic, logistic, and perception considerations of the key actors in the dairy industry. This promising tool can be applied to other infectious diseases that lack a well-established diagnostic procedure to define a herd status.

Diagnostic Accuracy of the Abbott SD Bioline MPT64 antigen test for identification of MTB Complex in a U.S. Clinical Mycobacteriology Laboratory

Identification of the Mycobacterium tuberculosis complex (MTBC) from culture and differentiation from other non-tuberculous mycobacterial species is required for rapid diagnosis and accurate treatment. However, gaps exist in culture-based identification of acid-fast bacilli (AFB) positive cultures for rapid rule-out of MTBC in the United States. The SD Bioline™ MPT64 (Abbott Inc, South Korea) lateral flow assay (LFA) has high sensitivity and specificity for the detection of MTBC in liquid culture but has not been evaluated in a clinical mycobacteriology laboratory in the United States. We conducted a diagnostic accuracy study of this LFA for detection of MTBC versus NTMs on AFB positive cultures. A total of 362 tests were performed, with a sensitivity and specificity of 100 % (362/362) across all tests. The SD Bioline MPT64 assay provides accurate test results with AFB-positive liquid cultures and could fill the current gap for rapid rule-out of MTBC in U.S.-based clinical laboratories.

Diagnostic accuracy of the Enferplex Bovine TB antibody test using individual milk samples from cattle.

Bovine tuberculosis is usually diagnosed using tuberculin skin tests or at post-mortem. Recently, we have developed a serological test for bovine tuberculosis in cattle which shows a high degree of accuracy using serum samples. Here, we have assessed the performance of the test using individual bovine milk samples. The diagnostic specificity estimate using the high sensitivity setting of the test was 99.7% (95% CI: 99.2-99.9). This estimate was not altered significantly by tuberculin boosting. The relative sensitivity estimates of the test using the high sensitivity setting in milk samples from comparative skin test positive animals was 90.8% (95% CI: 87.1-93.6) with boosting. In animals with lesions, the relative sensitivity was 96.0% (95% CI: 89.6-98.7). Analysis of paired serum and milk samples from skin test positive animals showed correlation coefficients ranging from 0.756-0.955 for individual antigens used in the test. Kappa analysis indicated almost perfect agreement between serum and milk results, while McNemar marginal homogeneity analysis showed no statistically significant differences between the two media. The positive and negative likelihood ratio were 347.8 (95% CI: 112.3-1077.5) and 0.092 (95% CI: 0.07-0.13) respectively for boosted samples from skin test positive animals. The results show that the test has high sensitivity and specificity in individual milk samples and thus milk samples could be used for the diagnosis of bovine tuberculosis.

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.

Nonword Repetition in Children With Developmental Language Disorder: Revisiting the Case of Cantonese.

Nonword repetition (NWR) has been described as a clinical marker of developmental language disorder (DLD), as NWR tasks consistently discriminate between DLD and typical development (TD) cross-linguistically, with Cantonese as the only reported exception. This study reexamines whether NWR is able to generate TD/DLD group differences in Cantonese-speaking children by reporting on a novel set of NWR stimuli that take into account factors known to affect NWR performance and group differentiation, including lexicality, sublexicality, length, and syllable complexity. Sixteen Cantonese-speaking children with DLD and 16 age-matched children with TD repeated two sets of high-lexicality nonwords, where all constituent syllables are morphemic in Cantonese but meaningless when combined, and one set of low-lexicality nonwords, where all constituent syllables are nonmorphemic. Low-lexicality nonwords were further classified on sublexicality in terms of consonant-vowel (CV) combination attestedness (whether or not CV combinations in nonword syllables occur in real Cantonese words). Children with DLD scored significantly below their peers with TD. Effect sizes showed that high-lexicality nonwords and nonword syllables with attested CV combinations offered the greatest TD/DLD group differentiation. Nonword length and syllable complexity did not affect TD/DLD group differentiation. NWR can capture TD/DLD group differences in Cantonese-speaking children. Lexicality and sublexicality effects must be considered in designing NWR stimuli for TD/DLD group differentiation. Future studies should replicate the present study on a larger sample size and a younger population as well as examine the diagnostic accuracy of this NWR test. https://doi.org/10.23641/asha.25529371.

Evaluation of the Analytical Performance of a Lateral Flow Assay for the Detection of Anti-Coccidioides Antibodies in Human Sera-Argentina.

Coccidiomycosis is a potentially life-threatening fungal infection endemic to certain regions of Argentina. The infection is caused by Coccidioides spp. and is primarily diagnosed by Coccidioides antibody (Ab) detection. Access to rapid, highly accurate diagnostic testing is critical to ensure prompt antifungal therapy. The sōna Coccidioides Ab Lateral Flow Assay (LFA) performs faster and requires less laboratory infrastructure and equipment compared with other Ab detection assays, potentially providing a substantial improvement for rapid case screening in coccidioidomycosis-endemic regions; however, validation of this test is needed. Thus, we aimed to evaluate the analytical performance of the sōna Coccidioides Ab (LFA) and compare agreement with anti-Coccidioides Ab detection assays. A total of 103 human sera specimens were tested, including 25 specimens from patients with coccidioidomycosis and 78 from patients without coccidioidomycosis. The sōna Coccidioides Ab Lateral Flow Assay (LFA) was performed with a sensitivity of 88%, and specificity and accuracy of 87%. Furthermore, the Coccidioides Ab LFA had good agreement with other anti-Coccidioides Ab detection assays. Our findings suggest the sōna Coccidioides Ab LFA has satisfactory performance and may be useful for diagnosing coccidioidomycosis in endemic regions.

PRIDASE 2024 guidelines for reporting diagnostic accuracy studies in endodontics: A consensus-based development.

Studies investigating the accuracy of diagnostic tests should provide data on how effectively they identify or exclude disease in order to inform clinicians responsible for managing patients. This consensus-based project was undertaken to develop reporting guidelines for authors submitting manuscripts, which describe studies that have evaluated the accuracy of diagnostic tests in endodontics. These guidelines are known as the Preferred Reporting Items for Diagnostic Accuracy Studies in Endodontics (PRIDASE) 2024 guidelines. A nine-member steering committee created an initial checklist by integrating and modifying items from the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 checklist and the Clinical and Laboratory Images in Publications (CLIP) principles, as well as adding a number of new items specific to the specialty of endodontics. Thereafter, the steering committee formed the PRIDASE Delphi Group (PDG) and the PRIDASE Online Meeting Group (POMG) in order to collect expert feedback on the preliminary draft checklist. Members of the Delphi group engaged in an online Delphi process to reach consensus on the clarity and suitability of the items in the checklist. The online meeting group then held an in-depth discussion on the online Delphi-generated items via the Zoom platform on 20 October 2023. According to the feedback obtained, the steering committee revised the PRIDASE checklist, which was then piloted by several authors when preparing manuscripts describing diagnostic accuracy studies in endodontics. Feedback from this process resulted in the final version of the PRIDASE 2024 checklist, which has 11 sections and 66 items. Authors are encouraged to use the PRIDASE 2024 guidelines when developing manuscripts on diagnostic accuracy in endodontics in order to improve the quality of reporting in this area. Editors of relevant journals will be invited to include these guidelines in their instructions to authors.

Prognostic nutritional index as a predictive marker for acute kidney injury in adult critical illness population: a systematic review and diagnostic test accuracy meta-analysis

BackgroundThe prognostic nutritional index (PNI), integrating nutrition and inflammation markers, has been increasingly recognized as a prognostic predictor in diverse patient cohorts. Recently, its effectiveness as a predictive marker for acute kidney injury (AKI) in various clinical settings has gained attention. This study aims to assess the predictive accuracy of the PNI for AKI in critically ill populations through systematic review and meta-analysis.MethodsA systematic review was conducted using the databases MEDLINE, EMBASE, PubMed, and China National Knowledge Infrastructure up to August 2023. The included trials reported the PNI assessment in adult population with critical illness and its predictive capacity for AKI. Data on study characteristics, subgroup covariates, and diagnostic performance of PNI, including sensitivity, specificity, and event rates, were extracted. A diagnostic test accuracy meta-analysis was performed. Subgroup analyses and meta-regression were utilized to investigate the sources of heterogeneity. The GRADE framework evaluated the confidence in the meta-analysis’s evidence.ResultsThe analysis encompassed 16 studies with 17 separate cohorts, totaling 21,239 patients. The pooled sensitivity and specificity of PNI for AKI prediction were 0.67 (95% CI 0.58–0.74) and 0.74 (95% CI 0.67–0.80), respectively. The pooled positive likelihood ratio was 2.49 (95% CI 1.99–3.11; low certainty), and the negative likelihood ratio was 0.46 (95% CI 0.37–0.56; low certainty). The pooled diagnostic odds ratio was 5.54 (95% CI 3.80–8.07), with an area under curve of summary receiver operating characteristics of 0.76. Subgroup analysis showed that PNI’s sensitivity was higher in medical populations than in surgical populations (0.72 vs. 0.55; p < 0.05) and in studies excluding patients with chronic kidney disease (CKD) than in those including them (0.75 vs. 0.56; p < 0.01). Overall, diagnostic performance was superior in the non-chronic kidney disease group.ConclusionOur study demonstrated that PNI has practical accuracy for predicting the development of AKI in critically ill populations, with superior diagnostic performance observed in medical and non-CKD populations. However, the diagnostic efficacy of the PNI has significant heterogeneity with different cutoff value, indicating the need for further research.

Validation of self-applied unattended polysomnography using Somte V2 PSG (Somte) for diagnosis of obstructive sleep apnoea (OSA) in pregnant women in early to mid-gestation

PurposePolysomnography (PSG) may be completed in the home environment (unattended), and when self-applied, allow the collection of data with minimal healthcare worker intervention. Self-applied, unattended PSG in the home environment using Somte PSG V2 (Somte) has not been validated in pregnant women in early to mid-gestation. We undertook a study to evaluate the accuracy of Somte compared to attended PSG. The agreement between apnoea hypopnea index (AHI) and respiratory disturbance index (RDI) scores in Somte and PSG in early to mid-gestation were assessed.MethodsPregnant women (≤ 24 weeks gestation) were scheduled for PSG and Somte within a 7-day window, in any order. Somte were self-applied and completed in the home. Somte were scored blinded to PSG result. AHI was the primary outcome of interest, though an AHI ≥ 5 or RDI ≥ 5 on PSG was considered diagnostic of Obstructive Sleep Apnoea (OSA). AHI, RDI, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) was calculated and receiver operating characteristic (ROC) curves were produced. Bland–Altman plots were used to determine agreement. Technical issues occurring during tests were explored.ResultsTwenty-four participants successfully completed both tests between March 2021 and January 2023. PSG were completed at around 14.1 weeks’ gestation (IQR 13.4, 15.7). The time interval between Somte and PSG was a median of 4 days (IQR 2, 7 (range 1–12)). Five (20.8%) women had OSA on PSG at AHI ≥ 5 and 10 (41.6%) women had OSA on PSG at RDI ≥ 5. Somte and PSG did not differ in the measurement of AHI ((1.8, 1.6, p = 0.09) or RDI (3.3, 3.5), p = 0.73).At AHI ≥ 5, diagnostic test accuracy (area under the ROC curve) of Somte was 0.94, sensitivity 80.0%, specificity 94.7%, PPV and NPV were 80.0% and 94.7% respectively. At RDI ≥ 5, diagnostic test accuracy (area under the ROC curve) was 0.95, sensitivity 60.0%, specificity 93.0% and PPV and NPV were 85.7% and 76.4% respectively. The confidence limits of Bland–Altman plots were 6.37 to − 8.89 at cut off AHI ≥ 5 and 8.89 to − 10.43 at cut off RDI ≥ 5. Somte failed to start in four tests. Technical issues were reported in both Somte (n = 13, 54.2%) and PSG (n = 6, 25.0%).ConclusionSelf-applied, unattended Somte may provide an acceptable substitute to attended PSG in the identification of OSA in pregnant women in early to mid-gestation in this small sample but may fail to detect cases of OSA, particularly when using RDI as the diagnostic marker.

Reliability and Validity Analyses of the Practical Assessment of Dysphagia Test in Stroke.

To investigate the validity and reliability of the Practical Assessment of Dysphagia (PAD) test as a quantitative and organ-specific test for stroke patients. In this study, PAD test data from 109 patients with stroke were used. The internal consistency of the PAD was analyzed using Cronbach's α value. Inter- and intra-rater reliabilities of the PAD were analyzed using Kappa coefficient. Concurrent validity was evaluated based on the correlation between PAD and the videofluoroscopic swallowing study (VFSS). The diagnostic accuracy of the PAD test in patients with stroke was measured using the area under the receiver operating characteristic (ROC) curve. Intra- and inter-rater reliabilities (Intra-class Correlation Coefficient (ICC) = 0.98 and 0.99, respectively) were significant (p < 0.001) for the total PAD score. The functional dysphagia scale (FDS) score and penetration-aspiration score (PAS) correlated significantly with PAD (p < 0.001). The results of the ROC curve analysis with various cut-off points showed that the PAD test had high sensitivity and specificity. The PAD has high reliability and validity. Therefore, it is a useful screening test for dysphagia in patients with stroke.

Validation of Sinhala and Tamil translations of the motherisk: Pregnancy unique quantification of emesis (PUQE) scoring system

Aims: Nausea and vomiting in pregnancy (NVP), where there are no other underlying causes, is one of the most common symptoms in the early part of the pregnancy. It is responsible for up to 80% of pregnant population. By using PUQE score system, it is very convenient to categorize pregnant women with nausea and vomiting come to outpatient department (OPD) or general practice into those who can manage in community setting or those who need inpatient treatments. Objectives: Validation of PUQE instrument to assess NVP and hyperemesis gravidarum (HG) women in Sri Lanka. Methods: Descriptive cross-sectional study conducted among 160 pregnant women presented to the Gynecology Unit of Teaching Hospital Anuradhapura (ATH) during three months duration. Translated self-administered PUQE questionnaire was applied to the patients with signs and symptoms with emesis in pregnancy. All study participants were undergoing clinical judgment as a confirmation test. Diagnostic test accuracy methods were used to assess criterion validity of the experimental tool. Data were analyzed by using SPSS statistical software version 25.0. Results: Study population has a mean age of 27.96 (SD 5.31). Majority of study participants were Sinhalese and according to the parity majority were primigravida pregnancies. Majority of study participants were diagnosed as NVP Stage II (N=134:53.8%) by the PUQE scoring system. According to the clinical judgment Stage II of NVP was diagnosed among 127 (79.4%) study participants. Mean score of the PUQE scale was 9.08 (SD=2.35). Reliability assessment of the PUQE scoring system was reported as an excellent level (Cronbach alpha=0.804). Five types of management strategies were detected among study participants. Significantly high percentage of study participants were given first line antiemetics and oral rehydration solutions. Calculated sensitivity of the PUQE scoring system to diagnose Stage I of NVP was 69.56% and specificity was 96.35%. Calculated sensitivity of the PUQE scoring system to diagnose Stage II of NVP was 100% and specificity was 78.78%. All pregnant women who were clinically detected as Stage II NVP patients were detected as Stage II NVP patients by the PUQE scoring system also. None of the false positives and false negatives regarding Stage II of NVP detected by the PUQE scoring system. Conclusion: First line antiemetics and oral rehydration solutions are usually used for treating pregnancy-related nausea and vomiting. Stage II NVP conditions were detected with a higher prevalence when NVP status was diagnosed clinically and with PUQE scoring system. Specificity of PUQE scoring system appeared higher while detecting NVP Stage I and for NVP Stage II, sensitivity of PUQE scoring system appeared high. For Stage III NVP, clinical judgments and PUQE scoring system values were completely compatible. Management strategies used for treating pregnancy-related hyperemesis status should be further studied. Conducting these studies at different study settings may help to achieve more successful results. Pregnancy unique quantification of emesis tool can be used to diagnose NVP status more descriptively. Also, this PUQE tool is a valid tool which can be effectively used for patient management. Application of PUQE scoring system should be published by planning and implementing staff awareness programs for both curative sector and public health sector.

Home-Monitoring Vision Tests to Detect Active Neovascular Age-Related Macular Degeneration

Most neovascular age-related macular degeneration (nAMD) treatments involve long-term follow-up of disease activity. Home-monitoring would reduce the burden on patients and their caregivers and release clinic capacity. To evaluate 3 vision home-monitoring tests for patients to use to detect active nAMD compared with diagnosing active nAMD at hospital follow-up during the after-treatment monitoring phase. This was a diagnostic test accuracy study wherein the reference standard was detection of active nAMD by an ophthalmologist at hospital follow-up. The 3 home-monitoring tests evaluated included the following: (1) the KeepSight Journal (KSJ [International Macular and Retinal Foundation]), which contains paper-based near-vision tests presented as word puzzles, (2) the MyVisionTrack (mVT [Genentech]) vision-monitoring mobile app, viewed on an Apple mobile operating system-based device, and (3) the MultiBit (MBT [Visumetrics]) app, viewed on an Apple mobile operating system-based device. Participants were asked to test weekly; mVT and MBT scores were transmitted automatically, and KSJ scores were returned to the research office every 6 months. Raw scores between hospital follow-ups were summarized as averages. Patients were recruited from 6 UK hospital eye clinics and were 50 years and older with at least 1 eye first treated for active nAMD for at least 6 months or longer to a maximum of 42 months before approach. Participants were stratified by time since starting treatment. Study data were analyzed from May to September 2021. The KSJ, mVT, and MBT were compared with the reference standard (in-hospital ophthalmologist examination). Estimated area under receiver operating characteristic curve (AUROC). The study had 90% power to detect a difference of 0.06, or 80% power to detect a difference of 0.05, if the AUROC for 2 tests was 0.75. A total of 297 patients (mean [SD] age, 74.9 [6.6] years; 174 female [58.6%]) were included in the study. At least 1 hospital follow-up was available for 312 study eyes in 259 participants (1549 complete visits). Median (IQR) home-monitoring testing frequency was 3 (1-4) times per month. Estimated AUROC was less than 0.6 for all home-monitoring tests, and only the KSJ summary score was associated with lesion activity (odds ratio, 3.48; 95% CI, 1.09-11.13; P = .04). Results suggest that no home-monitoring vision test evaluated provided satisfactory diagnostic accuracy to identify active nAMD diagnosed in hospital eye service follow-up clinics. Implementing any of these evaluated tests, with ophthalmologists only reviewing test positives, would mean most active lesions were missed, risking unnecessary sight loss.

Whole-Blood PCR Preferred for Timely Diagnosis of Neuroinvasive West Nile Virus Infections: Lessons From the 2021 Arizona Outbreak.

In 2021, the state of Arizona experienced the largest focal outbreak of West Nile virus (WNV) in US history. Timely and accurate diagnostic testing remains a challenge for WNV due to transient viremia and limited immunoassay specificity. Recent studies have identified whole blood (WB) and urine as more sensitive specimen types for the detection of WNV RNA. We evaluated ordering practices, test performance, and patient characteristics of probable and confirmed cases. In total, we identified 190 probable and proven cases, including 127 patients (66.8%) with neuroinvasive disease. Among all cases, only 29.5% had WNV polymerase chain reaction (PCR) testing ordered on WB, of which 80.3% resulted as positive, including 7 cases in which WNV serologic testing was negative and 5 cases for which serologic testing was not ordered. In comparison, only 23.7% of cases that had cerebrospinal fluid (CSF) PCR ordered had a positive result, including 3 cases that were negative by PCR on WB. In contrast, WNV PCR on WB detected 12 neuroinvasive cases that were CSF PCR negative. WNV PCR testing in urine was only ordered on 2 patients, both of whom were positive. Crossing cycle threshold (Ct) values were not significantly different between WB and CSF specimen types, nor was there a correlation between Ct value and days from symptom onset at the time of sample collection; all specimen types and time points had Ct values, with 98% above 30. WB was positive by WNV PCR in several patients for >7 days (range, 7-25 days) after symptom onset, as was the CSF PCR. Taken together, these findings indicate that WNV PCR testing on WB may be the best initial test for timely diagnosis of WNV infection, irrespective of clinical manifestation; however, if negative in patients with suspected neuroinvasive disease, WNV PCR testing on CSF should be ordered.

Diagnostic performance of different imaging modalities for splenic malignancies: A comparative meta-analysis

Background and objectivesThe spleen hosts both benign and malignant lesions. Despite multiple imaging modalities, the distinction between these lesions poses a diagnostic challenge, marked by varying diagnostic accuracy levels across methods. In this study, we aimed to evaluate and compare the diagnostic performance of various imaging techniques for detecting malignant splenic lesions. MethodsFollowing PRISMA guidelines, we searched PubMed, Scopus, and Web of Sciences databases for studies evaluating imaging techniques in detecting malignant splenic lesions. Data extraction included diagnostic accuracy metrics, and methodological quality was assessed using QUADAS-2. Diagnostic Test Accuracy meta-analyses were conducted using R (version: 4.2.1). Subgroup analyses and meta-regression were performed to compare different modalities and clinical settings. ResultsOur study included 28 studies (pooled sample size: 2358), primarily using retrospective designs with histopathology as the reference standard. PET scan demonstrated the highest diagnostic accuracy (AUC: 92 %), demonstrating a sensitivity of 93 % (95 % CI: 80.4 % - 97.7 %) and a specificity of 82.8 % (95 % CI: 71.1 % - 90.4 %). Contrast-enhanced ultrasound (CEUS), Contrast-enhanced CT scan, and contrast-enhanced MRI also showed impressive performance with AUCs of 91.4 %, 90.9 %, and 85.3 %, respectively. Differences among these modalities were not statistically significant, but they outperformed non-contrast-enhanced methods. PET and CEUS exhibited higher specificity for lymphoma cases compared to studies including other malignancies. Conclusion and clinical implicationsOverall, PET emerges as the best modality for splenic malignancies, and CEUS and CE-MRI show promise as potential alternatives, notably due to their reduced radiation exposure. Further research is essential for precise malignancy differentiation.