Performance of the BinaxNOW COVID-19 Antigen Rapid Diagnostic Test for the Detection of SARS-CoV-2

Background: Diagnosis of COVID-19 disease primarily relies on nucleic acid amplification tests (NAAT) that amplify and detect viral RNA in specimens. These methods are expensive and time consuming. Antigen-based rapid diagnostic tests can substantially decrease turnaround time.Methods: We analyzed paired anterior nares swabs collected from symptomatic patients and asymptomatic healthcare workers being tested COVID-19. One swab was used for a direct RDT and the results were compared to NAAT.Results: 89 paired specimens were evaluated. The positive percent agreement (PPA) for the antigen RDT was 68.2%, and the negative percent agreement (NPA) was 98.5%. Despite a low PPA, the Κ statistic was 0.733 indicating substantial agreement with the NAAT result. The median cycle number in paired specimens with concordant results was significantly lower than in discordant specimens (21.3 versus 32.3; P=0.003).Conclusions: The RDT showed modest PPA and high NPA when compared to NAAT. The quick TAT and use of an inexpensive test more frequently could be useful in settings in which results from NAAT testing is delayed.

Comparison of Outcomes Derived from the ActiGraph GT3X+ and the Axivity AX3 Accelerometer to Objectively Measure 24-Hour Movement Behaviors in Adults: A Cross-Sectional Study

The aim of this cross-sectional study is to investigate convergent validity of outcomes derived from the ActiGraph GT3X and Axivity accelerometer and to investigate feasibility and acceptability of using outcomes derived from these devices to measure 24-h movement behaviors (i.e., sleep, sedentary behavior, and physical activity) in adults during free-living conditions. Twenty-four adults (33.3% male; 39.79 ± 13.09 years old) simultaneously wore a hip-mounted ActiGraph and thigh-mounted Axivity during 48 consecutive hours. The ActiGraph was switched from hip to wrist during the night. To assess convergent validity between the two devices, Paired sample t-tests, linear regressions, Bland–Altman plots and κ statistic were conducted. Feasibility and acceptability of the devices was self-reported on a five-point scale. Daily time spent in 24-h movement behaviors differed between both devices. Except for sleep, the mean differences in daily time spent in the behaviors were clinically relevant and the limits of agreement were wide. For all 24-h movement behaviors, except for sleep and vigorous physical activity, proportional errors were observed. κ statistic showed substantial agreement for total physical activity and outstanding agreement for sedentary behavior and sleep. Adults perceived the Axivity as more practical than the ActiGraph to wear it for more than two days whereas the feasibility to wear it for two days was comparable. Depending on the measure, the observed biases were clinically relevant, proportional to the size of the measure and/or erratically variable. When taking into account the data processing approaches applied in this study, the ActiGraph and the Axivity cannot be used interchangeably to measure 24-h movement behaviors since the bias between both devices is clinically relevant and unpredictable.

Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials

Background: In clinical trials, the optimal method of adjudicating revascularization events as clinically or nonclinically indicated (CI) is to use an independent Clinical Events Committee (CEC). However, the Academic Research Consortium-2 currently recommends using physiological assessment. The level of agreement between these methods of adjudication remains unknown. Methods: Data for all CEC adjudicated revascularization events among the 3457 patients followed-up for 2-years in the TALENT trial, and 3-years in the DESSOLVE III, PIONEER, and SYNTAX II trial were collected and readjudicated according to a quantitative flow ratio (QFR) analysis of the revascularized vessels, by an independent core lab blinded to the results of the conventional CEC adjudication. The κ statistic was used to assess the level of agreement between the 2 methods. Results: In total, 351 CEC-adjudicated repeat revascularization events occurred, with retrospective QFR analysis successfully performed in 212 (60.4%). According to QFR analysis, 104 events (QFR ≤0.80) were adjudicated as CI revascularizations and 108 (QFR >0.80) were not. The agreement between CEC and QFR based adjudication was just fair (κ=0.335). Between the 2 methods of adjudication, there was a disagreement of 26.4% and 7.1% in CI and non-CI revascularization, respectively. Overall, the concordance and discordance rates were 66.5% and 33.5%, respectively. Conclusions: In this event-level analysis, QFR based adjudication had a relatively low agreement with CEC adjudication with respect to whether revascularization events were CI or not. CEC adjudication appears to overestimate CI revascularization as compared with QFR adjudication. Direct comparison between these 2 strategies in terms of revascularization adjudication is warranted in future trials. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: TALENT trial: NCT02870140, DESSOLVE III trial: NCT02385279, SYNTAX II: NCT02015832, and PIONEER trial: NCT02236975.

Short-Term Reproducibility of Masked Hypertension Among Adults Without Office Hypertension

The 2017 American College of Cardiology/American Heart Association blood pressure (BP) Hypertension Clinical Practice Guidelines recommends ambulatory BP monitoring to detect masked hypertension. Data on the short-term reproducibility of masked hypertension are scarce. The IDH study (Improving the Detection of Hypertension) enrolled 408 adults not taking antihypertensive medication from 2011 to 2013. Office BP and 24-hour ambulatory BP monitoring were performed on 2 occasions, a median of 29 days apart. After excluding participants with office hypertension (mean systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg), the analytical sample included 254 participants. Using the κ statistic, we evaluated the reproducibility of masked awake hypertension (awake systolic/diastolic BP ≥130/80 mm Hg) defined by the 2017 BP guideline thresholds, as well as masked 24-hour (24-hour systolic/diastolic BP ≥125/75 mm Hg), masked asleep (asleep systolic/diastolic BP ≥110/65 mm Hg), and any masked hypertension (high awake, 24-hour, and asleep BP). The mean (SD) age of participants was 38.0 (12.3) years and 65.7% were female. Based on the first and second ambulatory BP recordings, 24.0% and 26.4% of participants, respectively, had masked awake hypertension. The κ statistic (95% CI) was 0.50 (0.38–0.62) for masked awake, 0.57 (0.46–0.69) for masked 24-hour, 0.57 (0.47–0.68) for masked asleep, and 0.58 (0.47–0.68) for any masked hypertension. Clinicians should consider the moderate short-term reproducibility of masked hypertension when interpreting the results from a single ambulatory BP recording.

The Effect of Earlier Bone Grafting, Prior to Orthodontic Treatment, on SWAG Ratings of Graft Outcomes

Objective: To compare the outcomes between 2 groups of patients with complete clefts treated with early secondary alveolar bone grafting (ABG) at 2 centers (5-7 years, before orthodontic intervention) and to a third group of patients treated at one of those centers (center 1) who had received later secondary ABG (8-10 years, after orthodontic intervention). Design: Blind retrospective analysis of cleft site radiographs using Americleft Standardized Way to Assess Grafts (SWAG) scale. Patients: A total of 99 patients with complete clefts from 2 North American cleft/craniofacial centers. Interventions: Secondary ABG representing 2 protocols: early grafting at a mean age of 6.6 years prior to any orthodontic intervention, and later grafting at a mean age of 10.2 years following pregrafting orthodontic intervention. Main Outcome Measures: Using occlusal radiographs, the SWAG scale from 0 (failed graft) to 6 (ideal) was used. Six trained, calibrated raters scored each radiograph twice, with the average of the 2 ratings used as the final score. Reliability was assessed using the weighted κ statistic. The significance of differences between groups was determined using the Kruskal-Wallis test and Dunn test for pairwise comparisons. Results: Inter-rater reliability of SWAG method was good (0.631). Intra-rater reliability was excellent (0.817). There was a tendency for improved total graft outcome in the early grafted group from center 1 compared to the later grafted group with improvement being significantly different in only the coronal third of the early, preorthodontic grafted group. However, the difference was not statistically significant for the graft overall.

Content Validation through Expert Judgement of an Instrument on the Nutritional Knowledge, Beliefs, and Habits of Pregnant Women

The aim of this study was to conduct content validation through expert judgement of an instrument which explores the nutritional knowledge, beliefs, and habits during pregnancy. This is a psychometric study in which 14 experts participated in the evaluation of each of the questionnaire items, which were divided into two blocks according to the characteristics of sufficiency, clarity, coherence, and relevance. Fleiss’ κ statistic was used to measure strength of agreement. A pre-test with 102 participants was conducted to measure the degree of understandability of the instrument. The strength of agreement obtained for each of the dimensions was almost perfect. For each pair of experts, strength of agreement ranged between substantial and almost perfect. Sufficiency was the characteristic of the questionnaire that obtained the highest values in the two blocks, and was also the most statistically significant (p < 0.001). Coherence was the most statistically significant characteristic in the first block (p = 0.030). Clarity was the most statistically significant characteristic in the second block (p = 0.037). The wording of five of the twenty original items was corrected. The new version of the instrument attained a high degree of understandability. The results suggest that the instrument is valid and may therefore be applied.

CT-like MRI using the zero-TE technique for osseous changes of the TMJ

Objective: This study was conducted to assess the clinical usability of the zero-echo time (ZTE) technique of MRI for evaluating bone changes of the temporomandibular joint (TMJ) in comparison with CBCT. Methods: Twenty patients with TMJ disorder who underwent both CBCT and MRI were randomly selected. CBCT images were obtained with an Alphard 3030 device (Asahi Roentgen Ind., Co. Ltd, Kyoto, Japan). MRIs were obtained using a 3.0 T scanner (Pioneer; GE Healthcare, Waukesha, WI, USA) and a 21-channel head coil. An isotropic three-dimensional proton-density-weighted ZTE sequence was acquired. Two radiologists evaluated 40 joints of 20 patients for the presence of the following osseous changes: flattening, erosion, osteophyte and sclerosis of the condyle; and flattening, erosion and sclerosis of the articular fossa. CBCT and ZTE-MRI assessments were performed at a 2-month interval. The prevalence-adjusted and bias-adjusted κ statistic was used to analyse interexaminer and intraexaminer agreement and the agreement between ZTE-MRI and CBCT. Results: Intraexaminer and interexaminer agreement analyses of ZTE-MRI showed high reproducibility (κ>0.80), which was comparable to that of CBCT. Flattening, osteophyte and sclerosis of the condyle and all types of bone changes in the mandibular fossa showed nearly perfect agreement between CBCT and ZTE-MRI (κ = 0.80–0.90). Erosion of the condyle showed substantial agreement between both sets of images (κ = 0.65–0.70). Conclusions: It is suggested that ZTE-MRI provides clinically reliable images for bone assessment in TMJ disorder. MRI may become a beneficial diagnostic tool for patients with both TMJ disc and bone pathology, with advantages involving medical costs and radiation dose.

Clinical Implications of Estimating Glomerular Filtration Rate with Three Different Equations among Older People. Preliminary Results of the Project “Screening for Chronic Kidney Disease among Older People across Europe (SCOPE)”

We aimed at investigating to what extent CKD may be staged interchangeably by three different eGFR equations in older people, and evaluating the source of discrepancies among equations in a population of 2257 patients older than 75 years enrolled in a multicenter observational study. eGFR was calculated by CKD-EPI, BIS and FAS equations. Statistical analysis was carried out by Bland–Altman analysis. κ statistic was used to quantify the agreement between equations in classifying CKD stages. The impact of selected variables on the difference among equations was graphically explored. The average difference between BIS and FAS was −0.24 (95% limits of agreement (95%LA = −4.64–4.14) mL/min/1.73 m2. The difference between CKD-EPI and BIS and between CKD-EPI and FAS was 8.97 (95%LA = −2.90–20.84) and 8.72 (95%LA = −2.11–19.56) mL/min/1.73 m2, respectively. As regards CKD stage classification, κ value was 0.47 for both CKD-EPI vs. FAS and CKD-EPI vs. BIS, while BIS and FAS had similar classificatory properties (κ = 0.90). Muscle mass was found related to the difference between CKD-EPI and BIS (R2 = 0.11) or FAS (R2 = 0.14), but not to the difference between BIS and FAS. In conclusion, CKD-EPI and BIS/FAS equations are not interchangeable to assess eGFR among older people. Muscle mass may represent a relevant source of discrepancy among eGFR equations.

SPOT GRADE II: Clinical Validation of a New Method for Reproducibly Quantifying Surgical Wound Bleeding: Prospective, Multicenter, Multispecialty, Single-Arm Study

The SPOT GRADE (SG), a Surface Bleeding Severity Scale, is a unique visual method for assessing bleeding severity based on quantitative determinations of blood flow. This study assessed the reliability of the SG scale in a clinical setting and collected initial data on the safety and efficacy of HEMOBLAST Bellows (HB), a hemostatic agent, in abdominal and orthopedic operations. Twenty-seven patients were enrolled across 3 centers and received the investigational device. Bleeding severity and hemostasis were independently assessed by 2 surgical investigators at baseline and at 3, 6, and 10 minutes after application of HB and compared for agreement. The mean paired κ statistic for assignment of SG scores was .7754. The mean paired κ statistics for determining eligibility for participation in the trial based on bleeding severity and the mean paired κ statistics determining the presence of hemostasis were .9301 and .9301, respectively. The proportion of patients achieving hemostasis within 3, 6, and 10 minutes of HB application were 50.0%, 79.2%, and 91.7%, respectively. There were no unanticipated adverse device effects and one possible serious adverse device effect, as determined by the Independent Data Monitoring Committee (IDMC). The reliability of the SG scale was validated in a clinical setting. Initial data on the safety and efficacy of HB in abdominal and orthopedic operations were collected, and there were no concerns raised by the investigators or the IDMC.

Pretesting a political skill scale in a sample of teacher-leaders from polytechnics in northeast Nigeria

Although the Political Skill Inventory (PSI) is the benchmark measure of the political skill construct, the existence and frequent use of other measures suggest that the PSI fails to cover the content domain of the construct comprehensively. This study utilised the extant political skill measures in developing a robust and parsimonious political skill scale for assessing the political sensitivity of teacher-leaders in higher education. Cognitive tests, behaviour coding and respondent debriefing were conducted to evaluate a 38-item pool on political skill in a sample of 36 teacher-leaders drawn from nine polytechnics situated in Northeast Nigeria. The scale's interrater agreement was computed using Fleiss' κ statistic based on categorical data from five expert reviews. The results of our analyses revealed a 15-item Political Skill Scale (PSS) that reflects the social competence teacher-leaders need in performing the largely voluntary roles of teacher leadership. This work contributes towards contextual mapping of the political skill construct in an African setting. It also offers a new political skill measure.