Stand-alone Test Research Articles

Accuracy of combined molecular and morphology-based triage for HPV-positive women in routine cervical cancer screening services from Colombia

WHO cervical cancer elimination goals comprise 70% of highly-sensitive screening coverage and 90% treatment of precancerous lesions. Triage for HPV-positive women may challenge sensitivity of screening algorithms and women's follow-up, particularly in low- and middle-income countries (LMIC) where screening quality and protocol adherence are frequently deficient. We aimed to determine the accuracy of triage for HPV positive women in routine screening services from Colombia by a prospective cross-sectional study. Consecutively, HPV DNA-positive women underwent six triage strategies (conventional cytology, two methods of visual inspection, HPV16/18/45-genotyping, telomerase, and HPV mRNA). Positive triage results underwent regular colposcopy/biopsy in public hospitals. Adjusted sensitivity, specificity, and predictive values for CIN2+/CIN3+ were estimated for stand-alone and combined tests. We explored the impact of triage strategies on referral rates and the complete screening algorithm (screening plus triage). Overall 16,242 women underwent HPV screening and 1789 (11.0%) were HPV-positive. In total, 20.1% of women were lost to follow-up. mRNA showed the highest positivity rate (0.64 among HPV-positive and 0.05 among the total screened cohort), the highest sensitivity (0.94 95%CI 0.75–0.96), and the lowest specificity (0.36 95%CI 0.29–0.43). Parallel testing with HPV-mRNA revealed the highest increase in sensitivity for all triage strategies. Accuracy of cytology and visual inspection differ between screening units but parallel testing with HPV16/18/45 genotyping significantly increased their sensitivity (over 0.80). Morphology-based triage for HPV-positive women remains a suitable alternative for routine practice in LMIC if combined with HPV16/18/45-genotyping; however, point-of-care triage would be preferable to reduce losses to follow-up. HPV-mRNA triage deserves cost-benefit analyses.

A-183 Base Rates of Performance and Symptom Validity Test Failures in Active Duty and Veteran Samples Referred for Attention-Deficit/Hyperactivity Disorder Evaluation

Abstract Objective To evaluate base rates of abnormal MMPI-2-RF symptom validity test (SVT) and stand-alone performance validity test (PVT) scores in active duty (ad) service member and Veterans Affairs clinical samples referred for neuropsychological assessment of ADHD. Method MMPI-2-RF SVT scores and various PVTs were evaluated in two samples referred specifically for assessment of ADHD: service members (N = 82) and Veterans (N = 355). SVT and PVT outcomes were then compared to published data establishing invalid base rates in larger, more general samples. Results Elevated MMPI-2-RF overreport scales (F-r ≥ 79; FS, RBS, and FBS-r ≥ 80; & Fp-r ≥ 70) ranged from 14.6% (FBS-r) to 40.0% (RBS) in the ad sample and 12.0% (FBS-r) and 28.9% (RBS) in the veteran sample. MMPI-2-RF profiles that were invalidated due to overreport (e.g., F-r = 120, all others ≥100) were under 5% on the veteran sample and no greater than 6.1% in the ad sample. Elevations on underreport scales were higher in the veteran sample (L-r = 12.9%, K-r = 2.0%) than the ad sample (L-r = 3.7%, K-r = 1.2%). In the ad sample, 21.5% failed one PVT and 6.3% failed two. In the Veteran sample, 23.4% failed one PVT. Conclusions Elevated MMPI-2-RF overreport scales were relatively common on ad and Veterans referred for ADHD evaluations. However, frequencies of elevated and invalidated scales were diminished relative to overall base rates reported in national data. Regarding PVT failure, both samples were lower than national average invalid rates. Despite the incentive inherent in ADHD exams, invalidity in both samples were consistently lower for both SVTs and PVTs.

Energy Absorption and Limit Velocity of Epoxy Composites Incorporated with Fique Fabric as Ballistic Armor-A Brief Report.

Polymer composites reinforced with natural fabric have recently been investigated as possible ballistic armor for personal protection against different levels of ammunition. In particular, fabric made of fique fibers, which is extracted from the leaves of the Furcraea andina, was applied as reinforcement for polymer composites used in a multilayered armor system (MAS). The superior performance of the fique fabric composites as a second MAS layer motivated this brief report on the determination of the absorbed energy and capability to limit velocity in the stand-alone ballistic tests. The single plates of epoxy composites, which were reinforced with up to 50 vol% of fique fabric, were ballistic tested as targets against 7.62 mm high-speed, ~840 m/s, impact ammunition for the first time. The results were statistically analyzed by the Weibull method and ANOVA. The absorbed energies of the 200–219 J and limit velocities of 202–211 m/s were found statistically similar to the epoxy composites reinforced with the fique fabric from 15 to 50 vol%. Predominantly, these findings are better than those reported for the plain epoxy and aramid fabric (KevlarTM) used as stand-alone plates with the same thickness. Macrocracks in the 15 and 30 vol% fique fabric composites compromise their application as armor plates. The delamination rupture mechanism was revealed by scanning electron microscopy. By contrast, the integrity was maintained in the 40 and 50 vol% composites, ensuring superior ballistic protection compared to the use of KevlarTM.

Salvaging Detection of Early-Stage Ovarian Malignancies When CA125 Is Not Informative.

Background: Ovarian cancer is the deadliest gynecologic cancer, with no recommended screening test to assist with early detection. Cancer antigen 125 (CA125) is a serum biomarker commonly used by clinicians to assess preoperative cancer risk, but it underperforms in premenopausal women, early-stage malignancies, and several histologic subtypes. OVA1 is a multivariate index assay that combines CA125 and four other serum proteins to assess the malignant risk of an adnexal mass. Objective: To evaluate the performance of OVA1 in a cohort of patients with low-risk serum CA125 values. Study Design: We analyzed patient data from previous collections (N = 2305, prevalence = 4.5%) where CA125 levels were at or below 67 units/milliliter (U/mL) for pre-menopausal women and 35 U/mL for post-menopausal women. We compare the performance of OVA1 to CA125 in classifying the risk of malignancy in this cohort, including sensitivity, specificity, positive and negative predictive values. Results: The overall sensitivity of OVA1 in patients with a low-risk serum CA125 was 59% with a false-positive rate of 30%. OVA1 detected over 50% of ovarian malignancies in premenopausal women despite a low-risk serum CA125. OVA1 also correctly identified 63% of early-stage cancers missed by CA125. The most common epithelial ovarian cancer subtypes in the study population were mucinous (25%) and serous (23%) carcinomas. Despite a low-risk CA125, OVA1 successfully detected 83% of serous, 58% of mucinous, and 50% of clear cell ovarian cancers. Conclusions: As a standalone test, CA125 misses a significant number of ovarian malignancies that can be detected by OVA1. This is particularly important for premenopausal women and early-stage cancers, which have a much better long-term survival than late-stage malignancies. Using OVA1 in the setting of a normal serum CA125 can help identify at-risk ovarian tumors for referral to a gynecologic oncologist, potentially improving overall survival.

Mini-Mental State Examination (MMSE) for the early detection of dementia in people with mild cognitive impairment (MCI).

Dementia is a progressive global cognitive impairment syndrome. In 2010, more than 35 million people worldwide were estimated to be living with dementia. Some people with mild cognitive impairment (MCI) will progress to dementia but others remain stable or recover full function. There is great interest in finding good predictors of dementia in people with MCI. The Mini-Mental State Examination (MMSE) is the best-known and the most often used short screening tool for providing an overall measure of cognitive impairment in clinical, research and community settings. To determine the accuracy of the Mini Mental State Examination for the early detection of dementia in people with mild cognitive impairment SEARCH METHODS: We searched ALOIS (Cochrane Dementia and Cognitive Improvement Specialized Register of diagnostic and intervention studies (inception to May 2014); MEDLINE (OvidSP) (1946 to May 2014); EMBASE (OvidSP) (1980 to May 2014); BIOSIS (Web of Science) (inception to May 2014); Web of Science Core Collection, including the Conference Proceedings Citation Index (ISI Web of Science) (inception to May 2014); PsycINFO (OvidSP) (inception to May 2014), and LILACS (BIREME) (1982 to May 2014). We also searched specialized sources of diagnostic test accuracy studies and reviews, most recently in May 2014: MEDION (Universities of Maastricht and Leuven, www.mediondatabase.nl), DARE (Database of Abstracts of Reviews of Effects, via the Cochrane Library), HTA Database (Health Technology Assessment Database, via the Cochrane Library), and ARIF (University of Birmingham, UK, www.arif.bham.ac.uk). No language or date restrictions were applied to the electronic searches and methodological filters were not used as a method to restrict the search overall so as to maximize sensitivity. We also checked reference lists of relevant studies and reviews, tracked citations in Scopus and Science Citation Index, used searches of known relevant studies in PubMed to track related articles, and contacted research groups conducting work on MMSE for dementia diagnosis to try to locate possibly relevant but unpublished data. We considered longitudinal studies in which results of the MMSE administered to MCI participants at baseline were obtained and the reference standard was obtained by follow-up over time. We included participants recruited and clinically classified as individuals with MCI under Petersen and revised Petersen criteria, Matthews criteria, or a Clinical Dementia Rating = 0.5. We used acceptable and commonly used reference standards for dementia in general, Alzheimer's dementia, Lewy body dementia, vascular dementia and frontotemporal dementia. We screened all titles generated by the electronic database searches. Two review authors independently assessed the abstracts of all potentially relevant studies. We assessed the identified full papers for eligibility and extracted data to create two by two tables for dementia in general and other dementias. Two authors independently performed quality assessment using the QUADAS-2 tool. Due to high heterogeneity and scarcity of data, we derived estimates of sensitivity at fixed values of specificity from the model we fitted to produce the summary receiver operating characteristic curve. In this review, we included 11 heterogeneous studies with a total number of 1569 MCI patients followed for conversion to dementia. Four studies assessed the role of baseline scores of the MMSE in conversion from MCI to all-cause dementia and eight studies assessed this test in conversion from MCI to Alzheimer´s disease dementia. Only one study provided information about the MMSE and conversion from MCI to vascular dementia. For conversion from MCI to dementia in general, the accuracy of baseline MMSE scores ranged from sensitivities of 23% to 76% and specificities from 40% to 94%. In relationship to conversion from MCI to Alzheimer's disease dementia, the accuracy of baseline MMSE scores ranged from sensitivities of 27% to 89% and specificities from 32% to 90%. Only one study provided information about conversion from MCI to vascular dementia, presenting a sensitivity of 36% and a specificity of 80% with an incidence of vascular dementia of 6.2%. Although we had planned to explore possible sources of heterogeneity, this was not undertaken due to the scarcity of studies included in our analysis. Our review did not find evidence supporting a substantial role of MMSE as a stand-alone single-administration test in the identification of MCI patients who could develop dementia. Clinicians could prefer to request additional and extensive tests to be sure about the management of these patients. An important aspect to assess in future updates is if conversion to dementia from MCI stages could be predicted better by MMSE changes over time instead of single measurements. It is also important to assess if a set of tests, rather than an isolated one, may be more successful in predicting conversion from MCI to dementia.

Prenatal serum screening for Down syndrome and neural tube defects in the United States: Changes in utilization patterns from 2012 to 2020.

To compile current usage of serum-based prenatal screening for Down syndrome in the United States and compare it with results from a similar 2011/2012 survey. The College of American Pathologists maternal screening proficiency testing survey includes a supplemental question on the first of three yearly distributions. Information regarding tests offered and the monthly number of pregnancies tested for US-based laboratories were reviewed. Results were stratified by size of laboratory, tests offered, and pregnancies tested. Findings were compared to an earlier survey. Fifty-six laboratories reported they will have screened 1,131,336 pregnancies in 2020. Of these, 36% are screened by stand-alone first trimester testing, 48% by stand-alone second trimester testing, and 16% using tests that integrate results from both trimesters. Eighty percent of all serum screens were provided by the five laboratories that performed the most screens (at least 50,000). These five performed similar proportions of first or second trimester screens (42.2% and 41.8%, respectively). Compared to eight years earlier, there are now 54% fewer laboratories. Pregnancies screened using the first trimester, second trimester, and integrated protocols were lower by 27%, 69%, and 72%, respectively. The serum screening activity in the US showed a 62% decrease from 2012 levels. During 2012-2020, the number of cell-free DNA tests increased from negligible to 1,492,332. Maternal serum screening for common aneuploidies has changed significantly in eight years with fewer laboratories, a shift toward larger laboratories and a 2.5-fold reduction in pregnancies tested, likely due to the introduction of cell-free DNA screening.

Delivery of Pharmacogenetic Testing with or without Medication Therapy Management in a Community Pharmacy Setting.

ObjectiveThe delivery of pharmacogenetic (PGx) testing has primarily been through clinical and hospital settings. We conducted a study to explore the feasibility of delivering PGx testing through community pharmacies, a less-studied setting.MethodsWe conducted a cluster randomized trial of community pharmacies in North Carolina through two approaches: the provision of PGx testing alone or PGx testing with medication therapy management (MTM).ResultsA total of 150 patient participants were enrolled at 17 pharmacies and reported high satisfaction with their testing experience. Participants in the PGx plus MTM arm were more likely to recall a higher number of results (p=0.04) and more likely to clearly understand their choices for prevention or early detection of side effects (p=0.01). A medication or dose change based on the PGx results was made for 8.7% of participants.ConclusionLimited differences were observed in the provision of PGx testing as a standalone test or combined with MTM. A limited number of treatment changes were made based on PGx test results. Patient acceptance of PGx testing offered through the community pharmacy was very high, but the addition of MTM did not impact patient-reported perceptions about PGx testing or medication adherence.

The Usefulness of the Rapid Shallow Breathing Index in Predicting Successful Extubation: A Systematic Review and Meta-analysis

Clinicians use several measures to ascertain whether individual patients will tolerate liberation from mechanical ventilation, including the rapid shallow breathing index (RSBI). Given varied use of different thresholds, patient populations, and measurement characteristics, how well does RSBI predict successful extubation? We searched six databases from inception through September 2019 and selected studies reporting the accuracy of RSBI in the prediction of successful extubation. We extracted study data and assessed quality independently and in duplicate. We included 48 studies involving RSBI measurements of 10,946 patients. Pooled sensitivity for RSBI of< 105 in predicting extubation success was moderate (0.83 [95%CI, 0.78-0.87], moderate certainty), whereas specificity was poor (0.58 [95%CI, 0.49-0.66], moderate certainty) with diagnostic ORs (DORs) of 5.91 (95%CI, 4.09-8.52). RSBI thresholds of< 80 or 80 to 105 yielded similar sensitivity, specificity, and DOR. These findings were consistent across multiple subgroup analyses reflecting different patient characteristics and operational differences in RSBI measurement. As a stand-alone test, the RSBI has moderate sensitivity and poor specificity for predicting extubation success. Future research should evaluate its role as a permissive criterion to undergo a spontaneous breathing trial (SBT) for patients who are at intermediate pretest probability of passing an SBT. PROSPERO; No.: CRD42020149196; URL: www.crd.york.ac.uk/prospero/.

Next Generation Sequencing (NGS) Based IGH and TCR Clonality Assays Provide Excellent Specificity and Sensitivity for Routine Clonal Characterization and Monitoring of Lymphoproliferative Disorders

Background:IGH and TCR gamma clonality testing is an important component in the diagnosis of lymphoproliferative disorders. Capillary electrophoresis (CE) of multiplexed PCR products is currently considered the gold standard method of analysis. Although robust, simple and highly reproducible, it does not provide full characterization of clonal sequences and lacks sensitivity and specificity to track clones in subsequent samples. Here we describe our clinical implementation of an NGS based assay for routine assessment of lymphoproliferative disorders and outline the clinical utility for initial clonal characterization and minimal residual disease monitoring through patient specific clone tracking.Methods:Blood, bone marrow and FFPE tissue samples submitted for routine clonality assessment during Jan 2016 to March 2017 were identified. DNA was extracted and tested using both standard CE and LymphoTrack® IGH + TRG - MiSeq assays (InvivoScribe). Results were analyzed using an in-house developed software (LymphoClone) as well as proprietary InvivoScribe software. The lymphoma classification at the time of initial diagnosis, disease status and results of ancillary studies, including morphologic assessment, immunohistochemical analysis, flow cytometry (FC) and molecular test results were recorded for each case.Results:A total of 716 samples were analyzed, including 534 samples at the time of initial diagnosis (Dx) for clonal characterization and 182 follow up samples for disease monitoring. The case distribution is outlined in table 1. Sensitivity for initial clonal characterization was superior for the NGS assays, allowing clonal detection down to 1% tumor content, compared to 5-10% for the CE assays. Clonal rearrangement was detected in 94% of Dx cases by NGS (502/534) vs 89% CE (475/534). For monitoring samples with a previously characterized clone, NGS was equivalent to FC for detection of plasma cell neoplasms (PCN) but showed distinct advantages in disease monitoring for B-ALL, B and T cell lymphomas. Among 182 monitoring samples, NGS testing allowed residual disease detection in 25 (14%) more cases (137/182 vs 112/182) compared to flow cytometry. In all cases, residual disease was confirmed by an ancillary method (qPCR for a molecular marker) or a subsequent sample with higher disease level. The sensitivity for MRD detection for NGS has been established as 1x10-5. Sensitivity for FC ranged between 1x10-4 to 1x10-5 (1x10-4 for T and B-ALL and 1x10-5 for PCN and B cell lymphomas). Higher sensitivities may be attained by NGS with increasing DNA input. The NGS assay provided additional information on distinct clonal tumor population behavior, including suppression and/or re-emergence of subpopulations following treatment. In the current study, turnaround time (TAT) was higher for NGS vs FC, 9 days vs 1 day, respectively.Conclusions:Routine assessment of clonality by NGS methods is feasible and provides significant improvement over existing CE clonality assays, enabling comprehensive clonal characterization and disease monitoring with high sensitivity which is similar and often superior than FC. Based on current technology and protocols, TAT is longer for NGS compared to both CE and FC assays, which could limit its use as a stand-alone test in select clinical settings. Further protocol optimization is in progress to reduce this time to ~7 days. The NGS assays further define behaviors of clonal tumor populations and should therefore be considered in the routine assessment of lymphoid malignancies in conjunction with FC and other ancillary molecular tests. [Display omitted] DisclosuresArcila:Raindance Tecnologies: Honoraria; Invivoscribe: Honoraria; Archer: Honoraria. Park:Amgen: Consultancy. Dogan:Seattle Genetics: Consultancy, Membership on an entity's Board of Directors or advisory committees; Peer Review Institute: Consultancy; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Roche Pharmaceuticals: Consultancy; Celgene: Consultancy.

Diagnostic accuracy of GeneXpert MTB/RIF assay for detection of tubercular pleural effusion.

India has been engaged in tuberculosis (TB) control activities for over 50 years and yet TB continues to remain India's important public health problem. The present study was conducted to compare the performance of GeneXpert MTB/RIF (GXpert) assay with composite reference standard in diagnosing cases of tubercular pleural effusion (TPE) and to evaluate the reliability of rifampicin resistance. A cross-sectional study was performed in a Department of Medicine of a rural teaching tertiary care hospital in central India. In all consecutive patients with pleural effusion on chest radiograph presenting to Department of Medicine, GXpert assay and composite reference standard was performed to evaluate the diagnostic accuracy of GXpert assay for detecting TPE in comparison to composite reference standard. Standard formulae were used to calculate the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV), positive likelihood ratios (LR+) and negative likelihood ratios (LR-). Mc-Nemar's test was applied to compare variables. All comparisons were two-tailed. We considered the difference to be statistically significant if the P value was less than 0.05. The sensitivity of the GXpert assay in diagnosing TPE was 16.6% among 158 study participants, the specificity was 100% and diagnostic accuracy was 52.5% which was statistically significant (p value < 0.05). It had a PPV of 100% (95%CI: 88.3% - 100%) and a NPV of 47.5% (95%CI: 39.3% - 55.7%). The LR+ and LR-were 23.5 (95%CI: 1.43-38.6) and 0.83 (95%CI: 0.76-0.91) respectively. GXpert assay has a very high specificity in diagnosing TPE but has a low sensitivity. In comparison to composite reference standard Thus its clinical utility is limited when used as a standalone test. A physician's clinical acumen in combination with routine pleural fluid analysis should be the key factor in the diagnosis of TPE in clinically and radiologically suspected patients, especially in high TB burden countries.

Endobronchial ultrasound for T4 staging in patients with resectable NSCLC

BackgroundIn lung cancer patients, accurate assessment of mediastinal and vascular tumor invasion (stage T4) is crucial for optimal treatment allocation and to prevent unnecessary thoracotomies. We assessed the diagnostic accuracy of linear endobronchial ultrasound (EBUS) for T4-status in patients with centrally located lung cancer. MethodsThis is a retrospective study among consecutive patients who underwent EBUS for diagnosis and staging of lung cancer in four hospitals in The Netherlands (Amsterdam, Leiden), Italy (Bologna) and Poland (Zakopane) between 04–2012 and 04−2019. Patients were included if the primary tumor was detected by EBUS and subsequent surgical-pathological staging was performed, which served as the reference standard. T4-status was extracted from EBUS and pathology reports. Chest CT’s were re-reviewed for T4-status. Results104 patients with lung cancer in whom EBUS detected the primary tumour, and who underwent subsequent surgical-pathological staging were included. 36 patients (35 %) had T4-status, based on vascular (n = 17), mediastinal (n = 15), both vascular and mediastinal (n = 3), or oesophageal invasion (n = 1). For EBUS, sensitivity, specificity, PPV and NPV for T4-status were (n = 104): 63.9 % (95 %CI 46.2–79.2 %), 92.6 % (83.7–97.6 %), 82.1 % (65.6–91.7 %), and 82.9 % (75.7–88.2 %), respectively. For chest CT (n = 72): 61.5 % (95 %CI 40.6–79.8 %), 37.0 % (23.2–52.5 %), 35.6 % (27.5–44.6 %), and 63.0 % (47.9–75.9 %), respectively. When combining CT and EBUS with concordant T4 status (n = 33): 90.9 % (95 %CI 58.7–99.8 %), 77.3 % (54.6–92.20 %), 66.7 % (47.5–81.6 %), and 94.4 % (721−99.1%), respectively. ConclusionBoth EBUS and CT alone are inaccurate for assessing T4-status as standalone test. However, combining a negative EBUS with a negative CT may rule out T4-status with high certainty.

New developments in defecatory studies based on biomechatronics

IntroductionDefecation is a complex process that is difficult to study and analyze directly. In anorectal disease conditions, the defecation process may be disturbed, resulting in symptoms including fecal incontinence and constipation. Current state-of-the-art technology measures various aspects of anorectal function but detailed analysis is impossible because they are stand-alone tests rather than an integrated multi-dimensional test. ObjectivesThe need for physiologically-relevant and easy-to-use diagnostic tests for identifying underlying mechanisms is substantial. We aimed to advance the field with integrated technology for anorectal function assessment. MethodsWe developed a simulated stool named Fecobionics that integrates several tests to assess defecation pressures, dimensions, shape, orientation and bending during evacuation. A novelty is that pressures are measured in axial direction, i.e. in the direction of the trajectory. Using this novel tool, we present new analytical methods to calculate physiologically relevant parameters during expulsion in normal human subjects. ResultsData are reported from 28 human subjects with progressively more advanced versions of Fecobionics. A new concept utilizes the rear-front pressure (preload-afterload) diagram for computation of novel defecation indices. Fecobionics obtained physiological data that cannot be obtained with current state-of-the-art technologies. ConclusionFecobionics measures well known parameters such as expulsion time and pressures as well as new metrics including defecation indices. The study suggests that Fecobionics is effective in evaluation of key defecatory parameters and well positioned as an integrated technology for assessment of anorectal function and dysfunction.

The Development and Validation of the Embedded Validity Indicator for the Neuropsychological Assessment Battery.

The purpose of this study was to develop and validate an embedded measure of performance validity within the Neuropsychological Assessment Battery (NAB). This study involved a retrospective chart review at an outpatient neuropsychology clinic. Participants were 183 adults (ages 18-70) who completed the attention and memory modules of the NAB, as well as the Word Choice Test, Green's Medical Symptom Validity Test (MSVT), and Green's Non-Verbal MSVT, as part of a clinical neuropsychological assessment (n=147) or as part of a forensic neuropsychological evaluation (n=36). Replicating methodology utilized by Silverberg etal. (2007) for the development of the Effort Index within the Repeatable Battery for the Assessment of Neuropsychological Status, an Embedded Validity Indictor (EVI) for the NAB was developed in the present study based on Digits Forward and List Learning Long Delayed Forced-Choice Recognition (list recognition) subtests. Receiver operating characteristic curve analyses indicated the newly developed NAB EVI was able to significantly differentiate between valid and invalid status on stand-alone performance-validity tests, with area under the curve values ranging from 0.797 to 0.977. Optimal cutoffs for medical, forensic, and mixed samples were identified. The newly developed NAB EVI shows promise as an embedded performance validity measure; however, due to moderate sensitivity, it should be used in combination with stand-alone performance validity tests to detect invalid performance.

Comparison of resting/postexercise ankle-brachial index and transcutaneous partial pressure of oxygen for noninvasive diagnosis of peripheral artery disease in type 2 diabetes mellitus

Background: Type 2 diabetesType 2 diabetes mellitus (T2DM) is a strong risk factor for peripheral artery disease (PAD) and PAD diagnosis in T2DM may indicate coexisting coronary artery disease as well. Postexercise ankle brachial index (ABI) and transcutaneous partial pressure of oxygen (TcPO2) have not been evaluated for PAD diagnosis among Indian T2DM patients. This study aimed to evaluate the performance of resting + postexercise(R + PE) ABI and R + PE-TcPO2 for PAD diagnosis among T2DM patients at increased PAD risk, using colour duplex ultrasound (CDU) as reference standard. MethodsThis prospectively conducted diagnostic accuracy study involved T2DM patients at increased PAD risk. R-ABI≤0.9 or PE-ABI decline >20% from resting value in those with R-ABI between 0.91 and 1.4, R–TcPO2 <30 mm Hg or PE decline of TcPO2 to <30 mm Hg in those with R–TcPO2 ≥30 mm Hg, CDU showing >50% stenosis or complete occlusion of lower extremity arteries constituted PAD. ResultsAmong 168 patients enrolled, R + PE-ABI diagnosed PAD in 19(11.3%), R + PE-TcPO2 in 61 (36.3%) and 17 (≈10%) had PAD finally confirmed by CDU. Sensitivity, specificity, PPV and NPV of R + PE-ABI for PAD diagnosis were 82.3%, 96.7%, 73.7% and 98% and that of R + PE-TcPO2 were 76.5%, 68.2%, 21.3% and 96.2%, respectively. PE-ABI increased the sensitivity of ABI by ≈ 18% and had 100% PPV for PAD. When both ABI and TcPO2 (R + PE tests) were normal, PAD could be safely excluded in 88% of patients. ConclusionPE-ABI should be routinely employed and TcPO2(R/PE) is unreliable as a stand-alone test for PAD detection among moderate to high risk T2DM patients.

Comparison of HIV-Positive Incidence Among Transgender Women and Men Who Have Sex with Men at Stand-Alone and Mobile Voluntary Counseling and Testing Facilities in Chiang Mai Province, Thailand

Human immunodeficiency virus (HIV) infection is still a major cause of death in Thais and new cases of infection are still emerging among the key population comprising men who have sex with men (MSM), sex workers and their clients, and transgender women (TGW) and people who inject drugs. The objective of this study was to compare the incidence of HIV infection between MSM and TGW who were tested at stand-alone and mobile HIV voluntary counseling and testing (VCT) centers and to identify factors associated with HIV-positive individuals from the two services. We conducted an observational study using MSM and TGW individuals with unknown HIV status from the databases at a stand-alone center and a mobile VCT belonging to the MPlus in Chiang Mai province, Thailand. Factors associated with HIV-positive status were identified using logistic regression model. HIV VCT data were obtained for 6971 individuals at both MPlus center and mobile care unit. Among 3033 and 3938 clients tested at each facility, respectively, 168 (5.6%) and 101 (2.6%) clients were HIV positive. Individuals tested at the stand-alone centers were at a 1.91-fold higher risk of being HIV positive compared with those tested at the mobile VCT unit. Individuals who were 20-24 or >24 years old, sex workers, or sexually transmitted infection positive were more likely to be HIV positive. Our results show the beneficial effect of mobile HIV VCT facilities that enable testing of more of the at-risk population. Developing mobile VCT activities that attract a particular target population is needed to be able to reach the 90-90-90 goals. This study was approved by the Ethics Committee of the Faculty of Medicine, Chiang Mai University (0BG-2562-06418).

Performance validity and symptom validity tests: Are they measuring different constructs?

To evaluate the relationships among performance validity, symptom validity, symptom self-report, and objective cognitive testing. Combat Veterans (N = 338) completed a neurocognitive assessment battery and several self-report symptom measures assessing depression, posttraumatic stress disorder (PTSD) symptoms, sleep quality, pain interference, and neurobehavioral complaints. All participants also completed two performance validity tests (PVTs) and one stand-alone symptom validity test (SVT) along with two embedded SVTs. Results of an exploratory factor analysis revealed a three-factor solution: performance validity, cognitive performance, and symptom report (SVTs loaded on the third factor). Results of t tests demonstrated that participants who failed PVTs displayed significantly more severe symptoms and significantly worse performance on most measures of neurocognitive functioning compared to those who passed. Participants who failed a stand-alone SVT also reported significantly more severe symptomatology on all symptom report measures, but the pattern of cognitive performance differed based on the selected SVT cutoff. Multiple linear regressions revealed that both SVT and PVT failure explained unique variance in symptom report, but only PVT failure significantly predicted cognitive performance. Performance and symptom validity tests measure distinct but related constructs. SVTs and PVTs are significantly related to both cognitive performance and symptom report; however, the relationship between symptom validity and symptom report is strongest. SVTs are also differentially related to cognitive performance and symptom report based on the utilized cutoff score. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Cervical Cancer Screening: Comparison of Conventional Pap Smear Test, Liquid-Based Cytology, and Human Papillomavirus Testing as Stand-alone or Cotesting Strategies.

Some countries have implemented stand-alone human papillomavirus (HPV) testing while others consider cotesting for cervical cancer screening. We compared both strategies within a population-based study. The MARZY cohort study was conducted in Germany. Randomly selected women from population registries aged ≥30 years (n = 5,275) were invited to screening with Pap smear, liquid-based cytology (LBC, ThinPrep), and HPV testing (Hybrid Capture2, HC2). Screen-positive participants [ASC-US+ or high-risk HC2 (hrHC2)] and a random 5% sample of screen-negatives were referred to colposcopy. Post hoc HPV genotyping was conducted by GP5+/6+ PCR-EIA with reverse line blotting. Sensitivity, specificity (adjusted for verification bias), and potential harms, including number of colposcopies needed to detect 1 precancerous lesion (NNC), were calculated. In 2,627 screened women, cytological sensitivities (Pap, LBC: 47%) were lower than HC2 (95%) and PCR (79%) for CIN2+. Cotesting demonstrated higher sensitivities (HC2 cotesting: 99%; PCR cotesting: 84%), but at the cost of lower specificities (92%-95%) compared with HPV stand-alone (HC2: 95%; PCR: 94%) and cytology (97% or 99%). Cotesting versus HPV stand-alone showed equivalent relative sensitivity [HC2: 1.06, 95% confidence interval (CI), 1.00-1.21; PCR: 1.07, 95% CI, 1.00-1.27]. Relative specificity of Pap cotesting with either HPV test was inferior to stand-alone HPV. LBC cotesting demonstrated equivalent specificity (both tests: 0.99, 95% CI, 0.99-1.00). NNC was highest for Pap cotesting. Cotesting offers no benefit in detection over stand-alone HPV testing, resulting in more false positive results and colposcopy referrals. HPV stand-alone screening offers a better balance of benefits and harms than cotesting.See related commentary by Wentzensen and Clarke, p. 432.

ДОСВІД ЗАСТОСУВАННЯ LMS MOODLE ПРИ ДИСТАНЦІЙНОМУ НАВЧАННІ У ЗАКЛАДАХ ВИЩОЇ ОСВІТИ

High competition in the educational service market and the necessity to provide advanced level of quality in training of specialists require introducing into traditional educational form a new format based on information technologies and interactive methods of educational process by research and educational staff of higher education institution. The specific of MOODLE using for distance learning during the quarantine COVID-19 is considered and its advantages and disadvantages for training management and administration specialists are discussed in the article. The questionnaire which was carried out by authors among students of the Accounting and Finance Faculty of the Centralukrainian National Technical University in terms of their attitude about LMS MOODLE use for distance training during spring semester of 2019–2020 academic year students shows the next results: Most of the students had a positive attitude to distance learning – 48,3 %, negative – 34,5 %, neutral – 17,2 %. From students prospective the main advantages were the opportunity to study and work at the same time (32.4 %) to plan more flexible study schedule (29.7 %). Existence of such negative situation as wish to cheat while performing tests and tasks in MOODLE. Difficulties for lecturers to control stand-alone basis tests and tasks performance by students. The main problem was the independent study of lectures and practical tasks by students without teachers’ support. To improve the effectiveness of training asynchronous Moodle or Google Classroom platforms and learning sessions in Zoom, Meet, Skype, etc should be combined. This approach allows visualizing educational material with presentations and simplifying training materials by students, as well as expanding opportunities for students with special educational needs to obtain professions in management and administration.

Interrater Reliability among Novice Raters in the Assessment of Pelvic Floor Muscle Tone Using the Reissing Tone Scale.

Purpose: The authors sought to determine the interrater reliability among novice raters of intra-vaginal manual assessment of pubococcygeus muscle tone in women using the Reissing tone scale (RTS). Method: Three graduating physiotherapy students (novice raters) and one experienced pelvic floor physiotherapist assessed 31 female participants (aged 20-66 y). Assessors gave RTS scores for pubococcygeus tone at three intra-vaginal locations (6:00, 9:00, and 3:00). Interrater reliability was determined for the novice raters using a two-way random single-measures absolute agreement intra-class correlation coefficient (ICC). Spearman rank correlation (SRC) analysis determined the correlation between the novice and expert scores. Results: The ICC values for the novice raters were 0.523, 0.274, and 0.336 at 6:00, 9:00, and 3:00, and the SRC values between the novice and expert raters were 0.580, 0.320, and 0.340. Conclusions: The novice raters demonstrated low to moderate interrater reliability for intra-vaginal manual assessment of pubococcygeus tone. This result indicates that manual assessment of pelvic floor muscle tone is not reliable enough to use as a stand-alone test to guide treatment, at least for physiotherapists with limited clinical experience.

Superconducting Magnet Qualification Methodology for the Material Plasma Exposure Experiment

The Material Plasma Exposure eXperiment (MPEX), currently under design, is a new linear plasma device to advance the understanding of plasma-material interactions through the generation and delivery of plasmas as they are expected in future fusion reactor divertors. MPEX will be a steady-state device to study high-fluence exposures of plasma-facing materials and components. The requirements for the magnetic field at the target and the heating stages make the application of superconducting coils necessary. Conceptual designs for the superconducting magnets have been developed, and multiple cryostats with warm bore diameters of either 65 cm or 156 cm are envisioned to facilitate their integrated and timely assembly with other systems such as vacuum, water cooling, and RF power. Although design, fabrication, and testing for the magnets as stand-alone units are straightforward, challenges will arise during the integration of the system. Two different field profiles will be used during operation. The magnetic field where the electron cyclotron heating occurs needs to operate at both 1.25 and 2.5 T. It is critical that the magnets all share the same magnetic axis and alignment. The mutual inductance between cryostats will affect the quench behavior of the system. Also, cryostat-to-cryostat forces can be as large as 700 kN, and the magnitude and direction will change depending on which coils are energized. The design of the system must take those characteristics into account along with the quench scenarios. This paper describes the qualification approach that will be used to determine whether stand-alone tests can be used to ensure the success of the integrated system. Fiducials will be used to define the location of the magnetic axis for each cryostat to ensure proper alignment. Quench tests of a single magnet will be performed at a current above the normal operating current to account for additional stored energy from the mutual inductance to adjacent cryostats. Also, a 1018 steel plate will be mounted on either end of a cryostat to simulate the cryostat-to-cryostat forces. Requirements for the size and location of the steel plates are described.