Performance Of Screening Tests Research Articles

Effect of type of delivery and anesthesia method to ABR results on newborn hearing screening.

The aim of this study is to examine the effect of type of delivery and anesthesia method on the screening ABR test results of newborns within the scope of the Newborn Hearing Screening Program (NHCP) and to investigate the relationship between the test results and the relevant variables. 441 newborns were included in the study. Of these newborns, 221 constituted the control group (normal (vaginal) delivery), and 220 constituted the study group (cesarean section, delivery). In the study, all newborns whose hearing was evaluated within the scope of the Newborn Screening Program were screened twice. Screening ABR test results applied were compared considering the type of delivery (normal (vaginal) or cesarean section) and anesthesia method (spinal or general). The effects of variables such as the duration of the baby's separation (dissection) from the mother's womb, the duration of exposure to the anesthetic agent and the total duration of the surgical procedure were examined. As a result of the study, a statistically significant relationship was found between delivery type (normal (vaginal) or cesarean section) and anesthesia method (spinal or general) and first screening ABR test results (p<0.001). While there was a statistically significant difference (p<0.001) in terms of separation time from the mother's womb (p<0.001) and exposure to an anesthetic agent among the first test screening ABR results of newborns born under general anesthesia, there was no statistically significant difference (p<0.001) in terms of total surgical procedure time (p=0.106) no difference was detected. There was no statistically significant difference between ABR test results and these three variables in newborns born under spinal anesthesia (p>0.05). The type of delivery newborns and the anesthesia method used at delivery may affect the results of screening ABR applied within the scope of a newborn hearing screening protocol. For this reason, it is very important to perform screening tests at the most appropriate and correct time.

Diagnosis of naturally-occurring Cushing's syndrome by primary care veterinarians in selected European countries.

Several tests are available to diagnose naturally-occurring Cushing's syndrome in dogs but there is a paucity of information on how primary care veterinarians (PCVs) use or interpret them. Determine how PCVs from selected European countries diagnose Cushing's syndrome in dogs. Cross-sectional survey study assessing testing protocols used by PCVs for screening and differentiation of Cushing's syndrome. Two thousand one hundred and seventy-eight responses from 9 European countries were included. When Cushing's syndrome was suspected, 98.7% of respondents perform endocrine testing, whereas 1.2% rely on a treatment trial. Among the former, 59.9% reported performing screening tests in the absence of supportive clinical signs but with consistent clinicopathological abnormalities. Of 2150 respondents who performed endocrine testing, 66.6% report always using the same initial screening tests regardless of their pretest suspicion of disease. The tests most reported are the ACTH stimulation test (34.8%), low-dose dexamethasone suppression test (LDDST; 30.4%) or a combination of different tests (25.2%). In the absence of financial constraint, 1419 (66.0%) respondents always attempted differentiation, using abdominal ultrasonography (81.0%) and LDDST (46.1%). Overall, 69.8% of respondents reported offering referral to a specialist in ≤20% of cases suspected or diagnosed with Cushing's syndrome over the previous 5 years. Testing protocols vary among PCVs. Almost 60% of respondents potentially screen dogs without consistent clinical signs, raising concerns for overdiagnosis. A proportion never attempt differentiation, which likely affects prognosis. Cases are rarely referred to a specialist, reflecting that Cushing's syndrome is mainly managed in primary care practices. These results suggest that there is room for further education of PCVs.

B-308 Analytical and clinical performance of a novel ovarian cancer screening test in asymptomatic women

Abstract Background Ovarian cancer (OC) ranks among the deadliest gynecological cancers, often diagnosed at advanced stages when treatment options are limited. Costly sequencing methods and established immunoassay and imaging-based methods lack early-stage sensitivity, highlighting the need for a cost-effective test with improved performance. Extracellular vesicles (EVs) produced in abundance by all cells can potentially improve test sensitivity and detection of multiple colocalized cancer specific markers can improve test specificity. The randomized controlled trial UKCTOCS (United Kingdom Collaborative Trial of Ovarian Cancer Screening) where over 200,000 postmenopausal asymptomatic women were randomly assigned to three arms revealed no significant reduction in mortality with OC screening. We report on an EV-based OC Test performance in serum samples from asymptomatic postmenopausal women in UKCTOCS. Methods The OC Test was previously locked (biomarkers, method, cutoff) and validated in an independent cohort. We evaluated the OC Test in a blinded case-control study nested within the no screening (NS) and annual ultrasound screening (USS) arms of UKCTOCS. All UKCTOCS participants provided a blood sample at study entry. Cases were all women who developed high grade serous ovarian cancer (HGSOC) within 36 months following sample donation (spun within 28 hours). They were matched by age at collection (+/-2 years) to women who had no OC detected either before or within the trial follow up period (controls). Where a case had &amp;gt;1 sample within the 0-36 months period, the control sample was matched to the case sample closest to diagnosis. The OC Test was run with a locked method and classifier algorithm utilizing 3 independent biomarker combinations tested in duplicate. OC Test results were calculated based on a previously determined cutoff prior to unblinding of clinical outcomes. Run controls were prepared by harvesting conditioned media from COV413A cell cultures (an ovarian epithelial-serous carcinoma cell line), purifying EVs and spiking into pre-screened OC Test negative human plasma at three levels. Run controls were run twice per day, one replicate per run for 17 days. Results We retrospectively assessed 116 samples from 108 cases (63 clinical Dx NS, 15 clinical Dx USS, 30 screen detected USS) women with HGSOC and 1310 samples from 1310 controls. OC test sensitivity for HGSOC was 84% (36/43; 95% CI 69%-93%), Stage I/II sensitivity was 89% (8/9; 95% CI 51%-99%) and the AUC (area under the curve) was 0.93 for case samples drawn 0-12 months prior to clinical Dx and all control samples. The OC Test specificity was 98% (1099/1176, 95% CI 97%-98%). Within laboratory CVs were 20.9%, 12.7% and 0.6% for low negative, high negative and high positive run controls respectively. Data from 143 samples (10%, 9 cases, 134 controls) were excluded due to operator error, low sample volume or quality issues. Conclusions The OC Test is capable of highly sensitive detection of HGSOC within one year of clinical diagnosis including at the earliest stages of disease while maintaining exceptionally high specificity. The results demonstrate the potential application of the OC Test for ovarian cancer screening in asymptomatic women.

The Relationship Between Pre-Season Functional Screening Test Performance and Coaches' Perception of Soccer Performance in Adult Male Players

The Relationship Between Pre-Season Functional Screening Test Performance and Coaches' Perception of Soccer Performance in Adult Male Players

Viral Hepatitis and HIV Screening in Seasonal Mountain Workers: Feasibility and Results of a First French Experiment

Introduction: The Mobile Hepatitis Team (MHT) was set up in 2013, with main objective was to increase outreach screening care treatment access and cure of our target population. Target population was drugs users, prisoners, homeless, precarious people, migrants, and psychiatric patients. Seasonal workers working in mid-mountain ski resorts in the Eastern Pyrenees constitute a population at risk of viral hepatitis and HIV. This young population presents sexual risk behaviors and consumption of addictive products without regular access to care because of their mobility, moving from one workplace to another according to the seasons. They do not have a regular general practitioner, do not perform screening tests and there is no access to care other than the mandatory occupational medicine visit at the beginning of the season. In previous actions on the health aera of the high cantons of the department of Pyrénées-Orientales. We met with invested partners who referred us to this specific population of seasonal workers and their lack of access to screening and care, except for the occupational medicine hiring visit, organized before the beginning of the winter season, late November in early December. Objective: To detect viral hepatitis and HIV in a population at viral risk and far from care and offer them immediate treatment of the type of linkage to care “TEST TO CURE”. Methodology: 2-weeks HCV HBV and HIV finger sticks by trained nurses and orientation to the hepatology or the infectious units. Results: only 28 HCV finger sticks were completed. We also met 4 patients with known HCV serology. Three patients received DAA treatment and one patient spontaneous cured with negative RNA. One new patient had RNA C positive on balance sheet without social rights. We oriented him towards sour social worker to treat him later. Two patients had 2 real time HCV viral load not detected (including one post treatment follow-up) and one RNA negative without antiviral treatment, in case of HCV spontaneous clearance. For HBV, 16 finger sticks were completed, all negative. We did not meet as many seasonal workers as originally planned. This is why we conducted a second session over 2 days only targeted on these temporary accommodations. We realized 26 HCV and HIV finger sticks. One patient was HIV positive. HIV serology was unknow until our screening session. Nobody was HCV positive but 62% of screened people were drugs users or former drugs users. Discussion: our study was a success even the low number of people screened in the first 2-week session. The second 2-day session was more efficient. It was the first experience of hepatitis and HIV screening in this population of seasonal mountain workers. Conclusion: despite all limits, hepatitis and HIV screening among seasonal mountain workers was an innovative and efficient action. This action could be easily replicated in all populations of seasonal workers, whether in the mountains or by the sea.

Comparison of Two Automated Urine Analyzers (URiSCAN Super + YD Diagnostics and Sysmex UC-3500–UF-5000 Urine Chemistry Analyzer) with Routine Microscopy

Background and Aim: Urinalysis is one of the most commonly performed screening tests in the clinical laboratory to diagnose and monitor various urological as well as systemic conditions. Newly developed automated urine analyzers are expected to routinely screen urine in less time compared to conventional routine microscopy and provide clinicians with prompt clinical information with a lower false-negative rate. The study aimed to evaluate the diagnostic performance of the two automated urine analyzers, URiSCAN Super + YD Diagnostics and Sysmex UC-3500–UF-5000 urine analyzer and compare them with microscopy. Materials and Methods: This was a prospective study performed on 124 randomly selected samples of patients coming to the clinical pathology laboratory at a tertiary care hospital for 3 months between March 1, 2022 and May 30, 2022. Each sample was taken for both automated analyzer testing and microscopic evaluation. The results of urine examination consisting of cells, formed elements, and microorganisms were compared between both the automated urine analyzers and microscopy, and the degree of concordance was calculated utilizing Cohen’s kappa (κ) analysis to see the concordance between all three values. The statistical analyses were performed using SPSS version 25, developed by IBM Co, and P &lt; 0.05 was considered statistically significant. Results: The degree of concordance of red blood cell (RBC), white blood cell (WBC), and epithelial cells (ECs) was good between the two automated analyzers, URiSCAN Super + YD Diagnostics and Sysmex UC-3500–UF-5000 urine analyzer and microscopy with P &lt; 0.05. The concordance between the Sysmex UC-3500–UF-5000 urine analyzer and manual microscopy was better than between manual microscopy and URiSCAN Super + YD Diagnostics. There was no concordance between any of these methods for either crystals, cast, bacteria, and fungi with P &gt; 0.05. Conclusion: The results from the automated analyzers for RBCs, WBCs, and ECs were similar to the result of manual microscopy, and the analyzers can be relied on for testing and can help in reducing turnaround time of routine urine examination. However, bacteria, fungi, dysmorphic red cells, casts, and crystals need to be analyzed by microscopic examination before giving a final diagnosis.

Facial expressions to identify post-stroke: A pilot study

Background and Objective:Timely stroke treatment can limit brain damage and improve outcomes, which depends on early recognition of the symptoms. However, stroke cases are often missed by the first respondent paramedics. One of the earliest external symptoms of stroke is based on facial expressions. Methods:We propose a computerized analysis of facial expressions using action units to distinguish between Post-Stroke and healthy people. Action units enable analysis of subtle and specific facial movements and are interpretable to the facial expressions. The RGB videos from the Toronto Neuroface Dataset, which were recorded during standard orofacial examinations of 14 people with post-stroke (PS) and 11 healthy controls (HC) were used in this study. Action units were computed using XGBoost which was trained using HC, and classified using regression analysis for each of the nine facial expressions. The analysis was performed without manual intervention. Results:The results were evaluated using leave-one-our validation. The accuracy was 82% for Kiss and Spread, with the best sensitivity of 91% in the differentiation of PS and HC. The features corresponding to mouth muscles were most suitable. Conclusions:This pilot study has shown that our method can detect PS based on two simple facial expressions. However, this needs to be tested in real-world conditions, with people of different ethnicities and smartphone use. The method has the potential for a computerized assessment of the videos for use by the first respondents using a smartphone to perform screening tests, which can facilitate the timely start of the treatment.

Development of diagnostic algorithm for Cushing’s syndrome: a tertiary centre experience

PurposeNo consensus exists as the gold standard for Cushing’s Syndrome (CS) screening. This study aimed to evaluate the diagnostic accuracy and utility of late-night salivary cortisol (LNSC) and cortisone (LNSE), overnight dexamethasone suppression test (ODST), and urinary free cortisol (UFC) in developing a screening algorithm for CS.MethodsA retrospective, single-centre analysis on 93 adult patients referred to the Oxford Centre for Diabetes, Endocrinology, and Metabolism for CS evaluation (2017–2022). Data were analysed using binomial logistic regression and area under the receiver-operating curve (AUROC).ResultsFifty-three patients were diagnosed with CS. LNSC (sensitivity 87.5%, specificity 64.9%, AUC 0.76), LNSE (sensitivity 72.4%, specificity 85.7%, AUC 0.79), and ODST (sensitivity 94.7%, specificity 52.1%; AUC 0.74) demonstrated comparable effectiveness for CS diagnosis. Their combined application increased diagnostic accuracy (AUC 0.91). UFC was not statistically significant. Pre-test clinical symptom inclusion improved screening test performance (AUC LNSC: 0.83; LNSE: 0.84; ODST: 0.82). For CD diagnosis, LNSE + LNSC (AUC 0.95) outperformed ODST. Combining these with ACTH levels < 12.6 pmol/L perfectly distinguished MACS (AUC 1.00). ODST (AUC 0.76) exhibited superior performance (sensitivity 100.0%, specificity 52.2%) in MACS detection.ConclusionsLNSC, LNSE, and ODST are robust tools for CS screening, with their combined use offering the highest diagnostic precision. LNSE, especially when used with LNSC, is highly effective for CD diagnosis, exceeding ODST accuracy. ODST is preferable for MACS identification. Integrating ACTH levels markedly improves differentiation between CD and MACS. Conversely, UFC shows limited diagnostic utility.

Antenatal Screening Tests Performance during the First Wave of Coronavirus Disease 2019: Lessons Learned for Future Pandemics

Background: We aimed to explore screening test utilization and performance during pregnancy amidst pandemic, examining both nulliparous and multiparous women, and to compare screening test performance before and during the pandemic in multiparous women. Methods: A cross-sectional study of 500 pregnant women at Galilee Medical Center, Israel, explored the effects of coronavirus disease 2019 (COVID-19) on screening test performance during the first wave of the pandemic. Sociodemographic and data regarding screening test performance (including nuchal translucency (NT)), first-trimester biochemical test, early fetal scan, alpha-fetoprotein testing, second fetal scan, glucose tolerance test, diphtheria, tetanus, and acellular pertussis (Tdap) vaccination, and third-trimester ultrasonographic fetal growth assessment) were collected via face-to-face interviews using a medical questionnaire. Logistic regression was performed to identify factors that influenced screening test performance. Results: 234 (46%) women did not perform at least one screening test during their pregnancy. Of these, 42% attributed their decision to the impact of the COVID-19 pandemic. Among these, 18.8% were anxious about potential exposure, 16.2% cited medical staff isolations and cancelations, 5.6% reported being infected with COVID-19 or in self-isolation, and 4.3% faced challenges related to local quarantine. Of our cohort, 9.2% reported refusing emergency department (ED) referral due to anxiety regarding possible exposure. Only 44.3% of multiparous women performed all the screening tests during the pandemic, compared with 70.8% before the pandemic (p &lt; 0.001). Nearly half of this inadequate screening were directly associated with the pandemic. Women who reported inadequate pandemic-related screening test performance tended to be multiparous (adjusted odds ratio [aOR] = 6.43), to have low-risk pregnancies (aOR = 2.6), and to be members of Muslim and Druze minorities (aOR = 4.89 and aOR = 3.83, respectively). Conclusions: This study highlights the negative effect of the COVID-19 pandemic on antenatal screening test performance especially among women of minority ethnic backgrounds. Optimizing antenatal care services, grouping of tests, and on-site vaccinations may increase the adequacy of screening test performance. Implementing telehealth strategies emerges as an essential tool to enhance antenatal care compliance during pandemics.

The Association of Alzheimer's Disease-Related Blood-Based Biomarkers with Cognitive Screening Test Performance in the Congolese Population in Kinshasa.

Alzheimer's disease (AD), the most common cause of dementia, poses a significant global burden. Diagnosis typically involves invasive and costly methods like neuroimaging or cerebrospinal fluid (CSF) biomarker testing of phosphorylated tau (p-tau) and amyloid-β42/40 (Aβ42/40). Such procedures are especially impractical in resource-constrained regions, such as the Democratic Republic of Congo (DRC). Blood-based biomarker testing may provide a more accessible screening opportunity. This study aims to examine if AD-related blood-based biomarkers are associated with cognitive test performance in the Congolese population, where limited research has been conducted. In this cross-sectional study of 81 Congolese individuals, cognitive assessments (Alzheimer's Questionnaire (AQ) and Community Screening Interview for Dementia (CSID)) distinguished dementia cases from controls. Blood draws were taken to assess p-tau 181 and Aβ42/40 biomarkers. Relationships between the biomarkers and cognitive performance were analyzed using multiple linear regression models. Lower plasma Aβ42/40 was significantly associated with lower CSID scores and higher AQ scores, indicative of AD (p < 0.001). These relationships were observed in healthy controls (CSID p = 0.01, AQ p = 0.03), but not in dementia cases. However, p-tau 181 did not exhibit significant associations with either measure. Factors such as age, sex, education, presence of APOEɛ4 allele, did not alter these relationships. Understanding relationships between AD-related screening tests and blood biomarkers is a step towards utilization of blood-based biomarker tests as a screening tool for AD, especially in resource-limited regions. Further research should be conducted to evaluate blood biomarker test efficacy in larger samples and other populations.

Enhanced blood-based colorectal cancer screening with improved performance in detection of early stage disease.

68 Background: Blood based colorectal cancer (CRC) screening has been validated for use in average risk populations (ECLIPSE NCT#04136002; Guardant Health, USA). Here we present the performance of an enhanced version of a blood-based screening test developed to optimize detection of low shedding tumors by leveraging epigenomic features of cell-free DNA (cfDNA). Test performance was assessed across screen-relevant individuals from the intended use population, including a collection of screen-detected CRC and enriched cohort of individuals with endoscopy finding of CRC. Methods: We trained a regression model to classify whether aberrant cfDNA originated from individuals with CRC or non-ACN individuals and compared performance to an original model in a fixed set of screen-relevant samples sequenced to a median of 11M reads per sample across a panel approximately 1Mb in size. Model optimization focused on identifying training settings and samples to maximize detection of low shedding screen-relevant tumors and introduced noise reduction techniques to minimize technical variation. The final enhanced model was trained in over 4500 samples; the calling cut-off was set targeting 90% specificity in the average-risk population following US-Census age distribution. Analytical Limit of Detection (LoD) was estimated using ~5,000 in silico dilution samples generated from blood samples from 25 CRCs and ~1,650 non-ACNs. Results: This training approach yielded a 2X improvement in the analytical LoD95 (0.004% vs 0.008%) compared to the original model validated in the ECLIPSE trial. The model also yielded an increase in overall CRC clinical sensitivity from 84% to 91%, N=45, with notable sensitivity improvement from 76% to 88% in detecting early localized stage I/II CRC, N = 25, while maintaining specificity at 91%. Conclusions: This enhanced cfDNA-based CRC screening blood test shows improved performance in early stage CRC detection demonstrating the potential of continuous improvement in the performance of cfDNA-based screening tests powered by data and clinical insights.

Prospective study of a multi-modal blood-based test for colorectal cancer screening.

70 Background: Colorectal cancer (CRC) screening has proven to be a useful tool for the detection and prevention of CRC. However, adherence is low despite the multiple screening options available. A blood-based CRC screening test with optimized sensitivity and specificity may improve screening adherence. We aimed to prospectively evaluate the performance of a multimodal blood-based colorectal neoplasia screening test in individuals presenting for colonoscopy. Methods: This prospective, observational study was developed in four hospitals in Spain and enrolled individuals (45 – 84 years of age) undergoing colonoscopy, including diagnostic and screening colonoscopies, between March 2020 and September 2021. Eligible individuals consented to use of medical records for research and to provide a blood sample prior to colonoscopy procedure. Individuals were followed for one year. Whole blood was collected and shipped ambient to a central laboratory for analysis (Shield, Guardant Health, Redwood City, CA, USA). The blood-based colorectal neoplasia test is a 500kb next-generation sequencing based panel and bioinformatic platform that incorporates cell-free DNA (cfDNA) methylation-based partitioning to identify cancer related genomic alterations and epigenomic modifications (methylation and modifications in chromatin state). Results are integrated to yield a binary “positive” or “negative” result. Here we present findings correlating the blood-based test results with colonoscopy findings and findings from available 1-year follow-up data. Results: 556 out of 598 eligible individuals had an evaluable colonoscopy and a blood-based test result that passed quality control standards. Of the 556 individuals, 52% were female; median age was 55 years (21% age 45 – 49, 74% age 50 – 74, 4% age 75+). Reasons for colonoscopy were symptoms (49%), average risk screening (33%), positive stool-based test (6%), positive family history (11%) or other reasons (1%). Colorectal adenocarcinoma prevalence rate was 1.4%. Sensitivity for CRC detection was 100% (8/8; Stage I, 1; Stage II, 3; Stage III, 2; Stage IV, 2). Sensitivity for advanced adenoma (AA) detection was 22%. Specificity for advanced neoplasia (CRC + AA) was 91%. Negative predictive value (NPV) for CRC detection was 100% and positive predictive value (PPV) was 13%. 1-year follow-up data was available for 504 individuals, of whom 9 patients developed cancer (none CRC), of whom 1 had an initial positive Shield result. Conclusions: In this prospective study of individuals eligible for colonoscopy, sensitivity and specificity of the blood-based test showed a performance consistent with the available stool-based non-invasive screening options. This, combined with a more acceptable mode of testing suggests that this blood-based test may be a viable CRC screening option.

Circulating tumor DNA (ctDNA) positivity and its association with clinicopathological characteristics by novel blood-based test for colorectal cancer (CRC) screening from a multi-center large cohort: COSMOS-CRC-01.

69 Background: Blood-based CRC screening has yielded performance comparable to stool-based screening tests and may be a modality that addresses the adherence gap in CRC screening. To investigate the diagnostic performance and its clinical relevance, we evaluated the test performance of a blood-based CRC screening test in a large cohort of individuals enriched for advanced colorectal neoplasia and early CRCs. Methods: 501 individuals presenting to ten institutions in Japan from 2020 to 2021 for treatment of advanced adenomas (AAs) or CRCs were consented and provided a pre-treatment blood sample (40mL whole blood in Streck cfDNA blood collection tubes). All eligible individuals underwent surgery or endoscopic resection within 30 days after sample collection and the pathological specimens were reviewed to determine cancer histology and stage, as well as AA histology. Pre-treatment blood samples were analyzed with a multi-modal (genomic and epigenomic) cfDNA CRC detection assay (Shield, Guardant Health, USA). Final cfDNA results were correlated with clinical data to determine the association of clinicopathological characteristics with test sensitivity. This study is registered as a clinical trial under UMIN000037765. Results: 451/501 (90%) individuals met inclusion/exclusion criteria and provided adequate blood samples that passed testing quality control criteria. Median age at consent was 67.4 years (range 31 – 92). 44% were female. 214/451 (47%) had a prior positive fecal occult blood test (FOBT). Of individuals with a negative or unknown FOBT testing, 161/237 (68%) had GI symptoms (e.g. abdominal pain, bloody/narrowing stool, constipation/diarrhea). The test identified 88% (268/305) of CRCs, including 71% (79/111) Stage I, 98% (87/89) Stage II, 97% (90/93) Stage III, and 100% (12/12) Stage IV. Overall sensitivity in detecting Stage I-III was 87%. The test identified 37% (54/146) of AAs, including 49% (33/68) of carcinoma in situs and 24% (9/37) of AAs with high-grade dysplasia. Sensitivity for right-sided CRC was 84% (61/73), 87% (59/68) for left-sided CRC, and 90% (148/164) for rectal tumors. Stage I test sensitivity was significantly associated with tumor size (&gt;20mm; p&lt;0.01), left-sided or rectal tumor location (p&lt;0.05), and tumor depth (p&lt;0.01) in univariate analysis, whereas the tumor depth (T2) was the sole factor associated with test positivity (p&lt;0.05) in multivariate analysis. Specificity on this assay is 90% as determined in the ECLIPSE clinical study (NCT04136002). Conclusions: This study evaluates the performance of a blood-based test for CRC and its clinicopathological relevance in a large-scale cohort. In this population enriched for early colorectal neoplasia, the sensitivity was 88% for CRC and 37% for AAs. This performance is consistent with previous reports. Clinical trial information: UMIN000037765 .

Gestational diabetes mellitus in Cameroon: prevalence, risk factors and screening strategies.

The burden of gestational diabetes (GDM) and the optimal screening strategies in African populations are yet to be determined. We assessed the prevalence of GDM and the performance of various screening tests in a Cameroonian population. We carried out a cross-sectional study involving the screening of 983 women at 24-28 weeks of pregnancy for GDM using serial tests, including fasting plasma (FPG), random blood glucose (RBG), a 1-hour 50g glucose challenge test (GCT), and standard 2-hour oral glucose tolerance test (OGTT). GDM was defined using the World Health Organization (WHO 1999), International Association of Diabetes and Pregnancy Special Group (IADPSG 2010), and National Institute for Health Care Excellence (NICE 2015) criteria. GDM correlates were assessed using logistic regressions, and c-statistics were used to assess the performance of screening strategies. GDM prevalence was 5·9%, 17·7%, and 11·0% using WHO, IADPSG, and NICE criteria, respectively. Previous stillbirth [odds ratio: 3·14, 95%CI: 1·27-7·76)] was the main correlate of GDM. The optimal cut-points to diagnose WHO-defined GDM were 5·9 mmol/L for RPG (c-statistic 0·62) and 7·1 mmol/L for 1-hour 50g GCT (c-statistic 0·76). The same cut-off value for RPG was applicable for IADPSG-diagnosed GDM while the threshold was 6·5 mmol/L (c-statistic 0·61) for NICE-diagnosed GDM. The optimal cut-off of 1-hour 50g GCT was similar for IADPSG and NICE-diagnosed GDM. WHO-defined GDM was always confirmed by another diagnosis strategy while IADPSG and GCT independently identified at least 66·9 and 41·0% of the cases. GDM is common among Cameroonian women. Effective detection of GDM in under-resourced settings may require simpler algorithms including the initial use of FPG, which could substantially increase screening yield.

COVID-19 vaccine-associated lymphadenopathy: a review.

Following the introduction of RNA-based vaccines, COVID-19 vaccine-associated clinical lymphadenopathy (C19-LAP) has been reported as a side effect. Moreover, subclinical lymphadenopathy detected on imaging (SLDI) has also been observed, mainly as incidental findings while performing screening tests on oncological patients. In these cases, surgical lymphadenectomy, fine-needle aspiration cytology (FNAC) and core needle biopsy (CNB) have been used as a valuable diagnostic tool for SLDI and C19-LAP. In this review the clinical, histologic and cytologic features of SLDI and C19-LAP have been investigated. A search for studies that reported on C19-LAP and SLDI histopathology and cytopathology was performed on PubMed and Google Scholar, on 11 January 2023. Thirty-one reports on SLDI and C19-LAP were retrieved and included in a pooled analysis. In total, we included 54 patients with a median age of 47 years. In our research, surgical excision, CNB and/or FNAC of C19-LAP or SLDI enlarged lymph nodes have been performed in 54 cases. Of all cases, only two metastases were diagnosed and one case was diagnosed as reactive hyperplasia with atypical follicles. The remaining cases were reactive lymphadenopathy (28 cases), follicular hyperplasia (13 cases), Kikuchi-Fujimoto disease (6 cases), granulomatous lymphadenitis (2 cases), eosinophilic lymph node abscesses (1 case), Langherans cell histiocytosis (1 case), Rosai-Dorfman disease (1 case). SLDI and C19-LAP have represented a diagnostic dilemma, especially in oncologic patients. The role of different diagnostic tools for SLDI and C19-LAP has been discussed.

Artificial intelligence-based screening for amblyopia and its risk factors: comparison with four classic stereovision tests.

The development of costs-effective and sensitive screening solutions to prevent amblyopia and identify its risk factors (strabismus, refractive problems or mixed) is a significant priority of pediatric ophthalmology. The main objective of our study was to compare the classification performance of various vision screening tests, including classic, stereoacuity-based tests (Lang II, TNO, Stereo Fly, and Frisby), and non-stereoacuity-based, low-density static, dynamic, and noisy anaglyphic random dot stereograms. We determined whether the combination of non-stereoacuity-based tests integrated in the simplest artificial intelligence (AI) model could be an alternative method for vision screening. Our study, conducted in Spain and Hungary, is a non-experimental, cross-sectional diagnostic test assessment focused on pediatric eye conditions. Using convenience sampling, we enrolled 423 children aged 3.6-14 years, diagnosed with amblyopia, strabismus, or refractive errors, and compared them to age-matched emmetropic controls. Comprehensive pediatric ophthalmologic examinations ascertained diagnoses. Participants used filter glasses for stereovision tests and red-green goggles for an AI-based test over their prescribed glasses. Sensitivity, specificity, and the area under the ROC curve (AUC) were our metrics, with sensitivity being the primary endpoint. AUCs were analyzed using DeLong's method, and binary classifications (pathologic vs. normal) were evaluated using McNemar's matched pair and Fisher's nonparametric tests. Four non-overlapping groups were studied: (1) amblyopia (n = 46), (2) amblyogenic (n = 55), (3) non-amblyogenic (n = 128), and (4) emmetropic (n = 194), and a fifth group that was a combination of the amblyopia and amblyogenic groups. Based on AUCs, the AI combination of non-stereoacuity-based tests showed significantly better performance 0.908, 95% CI: (0.829-0.958) for detecting amblyopia and its risk factors than most classical tests: Lang II: 0.704, (0.648-0.755), Stereo Fly: 0.780, (0.714-0.837), Frisby: 0.754 (0.688-0.812), p < 0.02, n = 91, DeLong's method). At the optimum ROC point, McNemar's test indicated significantly higher sensitivity in accord with AUCs. Moreover, the AI solution had significantly higher sensitivity than TNO (p = 0.046, N = 134, Fisher's test), as well, while the specificity did not differ. The combination of multiple tests utilizing anaglyphic random dot stereograms with varying parameters (density, noise, dynamism) in AI leads to the most advanced and sensitive screening test for identifying amblyopia and amblyogenic conditions compared to all the other tests studied.

Implementation of Universal Newborn Hearing Screening in the Philippines: A Survey of Registered Newborn Hearing Centers.

Universal newborn hearing screening is mandated in the Philippines through the Universal Newborn Hearing Screening and Intervention Act of 2009 (RA 9709). Newborn hearing screening (NBHS) centers are required to perform screening tests, compile and submit data on screened newborns, and advise parents on the subsequent steps after NBHS. The study aimed to conduct a survey of the implementation of the Universal Newborn Hearing Screening and Intervention Program (UNHSIP) in the different regions of the country; and assess the information technology (IT) capabilities of hearing centers. Fifty-one NBHS centers across twelve regions were surveyed through on-site inspections in 2016. Data was gathered on the centers' testing capability, staffing, access to specialists, use of local protocols, connectivity, and IT capabilities. All surveyed centers followed the recommended protocols of the Manual of Operations of the Universal Newborn Hearing Screening and Intervention Act of 2009 (RA 9709). Among the 12 regions visited, only five (41.67%) had Category C centers with confirmatory testing and early amplification services as recommended. Majority of facilities (96.1%) were staffed by trained and certified personnel. A small percentage had access to subspecialists such as clinical audiologists (39.2%) and speech-language pathologists (23.5%). All facilities had computer access, but only 58.8% had internet access. Majority (94.1%) of the centers visited were not using the recommended data submission methods, specifically the use of registry cards and the online registry. Only 27.5% of centers had data on newborns who underwent confirmatory testing or early intervention. Facilities were found to be compliant to NBHS screening protocols and majority complied with certification requirements for staff; but were found to be non-compliant with use of registry cards or the online registry. Majority of centers were able to contact the parents of neonates who did not pass newborn screening, but had no system to track outcomes. Lack of confirmatory and early intervention services in identified areas emphasize the need for development of regional centers. It is recommended that measures to improve the utilization of the online registry are taken.

Usefulness of the Montreal Cognitive Assessment in Older Adults With Type 1 Diabetes.

Older adults with type 1 diabetes are at high risk for cognitive impairment, yet the usefulness of common cognitive screening instruments has not been evaluated in this population. A total of 201 adults ≥60 years of age with type 1 diabetes completed a battery of neuropsychological measures and the Montreal Cognitive Assessment (MoCA). Receiver operating characteristic (ROC) curves and Youden indices were used to evaluate overall screening test performance and to select an optimal MoCA cutoff score for detecting low cognitive performance, as defined as two or more neuropsychological test performances ≥1.5 SD below demographically corrected normative data. The ROC area under the curve (AUC) was 0.745 (P < 0.001). The publisher-recommended cutoff score of <26 resulted in sensitivity of 60.4% and specificity of 71.4%, whereas a cutoff score of <27 resulted in sensitivity of 75.0% and specificity of 61.0%. The Youden indices for these cutoff scores were 0.318 and 0.360, respectively. Minimally acceptable sensitivity (i.e., >0.80) was obtained when using a cutoff score of <28, whereas >0.80 specificity was obtained with a cutoff score of <25. The MoCA has modest overall performance (AUC 0.745) as a cognitive screening instrument in older adults with type 1 diabetes. The standard cutoff score of <26/30 may not adequately detect individuals with neuropsychological testing-defined abnormal cognition. The optimal MoCA cutoff score (based on the Youden index) was <27/30. A score of <28 resulted in acceptable sensitivity but was accompanied by low specificity (42%). Future studies with a more diverse population are needed to confirm these findings.

Evaluating the Reliability of Dipstick Drug Screens on Vitreous and Postmortem Blood as a Triage Modality in Forensic Pathology.

Dipstick drug screens are cheap, easy to use, and quick presumptive tests to detect common drugs of abuse. Dipsticks are designed for drug detection in urine. There is no literature regarding their potential use on fluids different from urine. The study aimed to determine the performance of dipstick screening tests on postmortem vitreous and blood specimens compared to urine dipsticks and final confirmatory toxicology analyses on blood. The study population included cases in which a complete toxicology analysis was performed. Each subject was screened for three substances: cocaine, fentanyl, and opiates. Dipstick results were checked by visual inspection. Results were compared with urine screening tests and quantitative, confirmatory toxicological analyses by gas chromatography/mass spectrometry on postmortem blood samples as the gold standards for screening and confirmatory analysis, respectively. There was a high number of false-negative results for opiates. Cocaine dipsticks in blood showed the highest reliability. Fentanyl dipsticks in vitreous showed a high number of false-negative results. Both vitreous and blood dipstick screening tests for all substances performed well on negative cases. When both blood and vitreous screening tests are negative, the chance that the confirmatory toxicology analysis will be positive is very low.

Stool-Based Colorectal Cancer Screening Test Performance Characteristics in Those With and Without Hemorrhoids

ObjectiveTo evaluate the effect of hemorrhoids on noninvasive stool test performance for colorectal cancer (CRC) screening. Patients and MethodsWe conducted a retrospective cohort study of test characteristics for the fecal immunochemical test (FIT) and the multitarget stool DNA (mt-sDNA) test, on the basis of hemorrhoid status, recorded at the time of colonoscopy, among patients enrolled in the pivotal prospective study for mt-sDNA that was conducted from June 2011, to May 2013. Test characteristics (sensitivity, specificity, positive, and negative predictive values) for FIT and mt-sDNA (performed < 90 days before colonoscopy) were stratified by the presence of hemorrhoids and compared. ResultsHemorrhoids were found in 51.7% (5163 of 9989) of the study cohort. Across all test characteristics, there were no statistically significant differences for FIT or mt-sDNA when stratified by hemorrhoid status. Analysis revealed mt-sDNA sensitivity of 44% and 41% for advanced precancerous lesions in nonhemorrhoidal and hemorrhoid patients, respectively (P=.41). The FIT sensitivity among the same lesion category was 24.9% in patients without hemorrhoids and 22.8% in those with hemorrhoids (P=.48). The mt-sDNA specificity was 86.4% in patients without hemorrhoids vs 87.7% in those with hemorrhoids (P=.67), although FIT specificity was 95.0% among patients without hemorrhoids vs 94.7% in those with hemorrhoids (P=.44). ConclusionThe presence of asymptomatic hemorrhoids did not adversely affect test performance in this large clinical study. These findings suggest that in the absence of overt gastrointestinal bleeding, FIT and mt-sDNA are options for CRC screening, irrespective of hemorrhoid status. Trial Registrationclinicaltrials.gov Identifier: NCT01397747