Dried blood spot (DBS) sample analysis for drug and metabolomic profiling in oncology clinical trials: Cost-effective decentralized sampling modality for precision Oncology

The COVID19 pandemic accelerated opportunities for innovation within the decentralization process of clinical trials with opportunities for implementation of patient-centric workflows for efficiency and cost-reduction. Decentralized sample collection, particularly whole blood using dried blood spots (DBS) provides the ideal mechanism for patient driven sample collection with ease of access to sample generation, drug level assessments and metabolomic prMegofiling, providing longitudinal real-time measure of drug specific pharmacodynamic readout for safety and efficacy. In this study, we report the development of a protocol for the capture and comprehensive profiling of metabolomics using dried blood spots from a cohort of 49 healthy volunteer donors. Using liquid chromatography combined with mass spectrometric (UPLC-MS/MS) methods an untargeted metabolomic approach resulted in the identification of >800 biochemicals of which a significant subset was found to be presented in corresponding matched plasma (from whole blood) samples. The biochemicals identified from the DBS samples included metabolites that were part of the lipid, amino acid, nucleotide, peptide, cofactors, carbohydrate and energy super pathways. A significant number of metabolites identified in the DBS samples were xenobiotics including those representing the biotransformation products of drugs. The overall metabolite profiles were analyzed for precision and accuracy of measure, variability in performance and dynamic range to establish benchmarks for evaluation. An additional cohort with a longitudinal sampling as part of the protocol provided the reproducibility of the analytic method for inter-day variability of metabolite performance over time. Although metabolomic profiles varied between individuals from a population perspective, there was minimal variation observed within individuals when samples were profiled longitudinally over several weeks. Thus, the protocols for DBS collection and the corresponding capture of a large set of metabolites with reproducible performance provides an opportunity for its implementation in oncological clinical trials as part of a de-centralized clinical trial solution.

Classification of "Near-patient" and "Point-of-Care" SARS-CoV-2 Nucleic Acid Amplification Test Systems and a first approach to evaluate their analytical independence of operator activities.

BACKGROUND: European legislation defines as "near-patient testing" (NPT) what is popularly and in other legislations specified as "point-of-care testing" (POCT). Systems intended for NPT/POCT use must be characterized by independence from operator activities during the analytic procedure. However, tools for evaluating this are lacking. We hypothesized that the variability of measurement results obtained from identical samples with a larger number of identical devices by different operators, expressed as the method-specific reproducibility of measurement results reported in External Quality Assessment (EQA) schemes, is an indicator for this characteristic. MATERIALS AND METHODS: Legal frameworks in the EU, the USA and Australia were evaluated about their requirements for NPT/POCT. EQA reproducibility of seven SARS-CoV-2-NAAT systems, all but one designated as "POCT", was calculated from variabilities in Ct values obtained from the respective device types in three different EQA schemes for virus genome detection. RESULTS: A matrix for characterizing test systems based on their technical complexity and the required operator competence was derived from requirements of the European In Vitro Diagnostic Regulation (IVDR) 2017/746. Good EQA reproducibility of the measurement results of the test systems investigated implies that different users in different locations have no recognizable influence on their measurement results. CONCLUSION: The fundamental suitability of test systems for NPT/POCT use according to IVDR can be easily verified using the evaluation matrix presented. EQA reproducibility is a specific characteristic indicating independence from operator activities of NPT/POCT assays. EQA reproducibility of other systems than those investigated here remains to be determined.

[Validation of a symptom scale for COVID-19 patients in ambulatory care]

Background: A symptom scale can be useful for the standardization of clinical evaluations and follow-up of COVID-19 patients in ambultaroy care. Scale development should be accompanied by an assessment of its reliablility and validity. Objective: To develop and measure the psychometric characteristics of a COVID-19 symptom scale to be answered by either healthcare personnel or adult patients in ambulatory care. Material and methods: The scale was developed by an expert panel using the Delphi method. We evaluated inter-rater reliability, where we defined a good correlation if Spearman's Rho was >= 0.8;test-retest, where we defined a good correlation if Spearman's Rho was >= 0.7;factor analysis using principal component methodology;and discriminant validity using Mann-Whitney's U test. A p < 0.05 was considered statistically significant. Results: We obtained an 8 symptom scale, each symptom is scored from 0-4, with a total minimum score of 0 and a maximum of 32 points. Inter-rater reliability was 0.995 (n = 31), test-retest showed correlation of 0.88 (n = 22), factor analysis detected 4 factors (n = 40) and discriminant capacity of healthy versus sick adults was significant (p < 0.0001, n = 60). Conclusions: We obtained a reliable and valid Spanish (from Mexico) symptom scale for COVID-19 ambulatory care, answerable by patients and health care staff. Copyright © 2023 Revista Medica del Instituto Mexicano del Seguro Social.

[Instrument validation that measures disruptive education on clinical training]

Background: During the contingency derived from the COVID-19 pandemic, there were no instruments assessing the aspects of clinical training, which is why it is necessary to have a questionnaire that let us know the opinion of medical students about the disruptive education. Objective: To validate a questionnaire designed to know the opinion of medical students about disruptive education in their clinical training. Material and methods: Validation cross-sectional study which was developed in three phases: 1) Elaboration of the questionnaire aimed at undergraduate medical students who include clinical science subjects in their curricular program;2) validation of content by Aiken's V test with 7 expert judges and reliability estimation with Cronbach's alpha coefficient in a pre-sample test with 48 students;3) analysis of the information through descriptive statistics, where the following results were observed: Aiken's V index of V = 0.816;Cronbach's alpha coefficient = 0.966. A total of 54 items were incorporated in the questionnaire after the pre-sampling test. Conclusions: We can rely on a valid and reliable instrument that objectively measures disruptive education in the clinical training of medical students. Copyright © 2023 Revista Medica del Instituto Mexicano del Seguro Social.

Design of a Laboratory Developed Assay to Aid in the Detection of Sars-Cov-2 Virus Rna in Oropharyngeal and Nasopharyngeal Swabs Adapted from the Cdc Protocol

Intro: SARS-CoV-2 is a single-strand enveloped RNA virus belonging to the family Coronaviridae. It was first recognized in late 2019 as causing COVID-19, and later declared a pandemic. The development of this assay aided in the detection of positive cases early in the pandemic which in turn facilitated the isolation of infected individuals to minimize the spread. Method(s): The SARS-CoV-2 RNA detection by real time RT-PCR is a molecular in vitro diagnostic test that aids in the detection and diagnosis of SARS-CoV-2 in nasopharyngeal and oropharyngeal specimens. This test is based on nucleic acid extraction and amplification technology and uses oligonucleotide primers and dual-labeled hydrolysis probes. RNA is isolated and purified from specimens using the Abbott m2000sp. This technology uses magnetic particles to capture and purify the RNA. The bound RNA is eluted and transferred to a 96 deep-well plate and is ready for amplification. The master mix is prepared manually and is added to a PCR plate together with the extracted RNA. The RNA is reverse transcribed to cDNA and subsequently amplified in the Abbott m2000rt. In this process, the probe anneals to a specific target sequence located between the forward and reverse primers. During the extension step of the PCR cycle, the 5' nuclease activity of Taq polymerase degrades the probe, causing the reporter dye molecules to be cleaved from their respective probes, increasing the fluorescence intensity. Fluorescence intensity is monitored at each PCR cycle on the Abbott m2000rt instrument. Finding(s): The clinical evaluation was performed by testing patient samples in a blinded fashion. The performance of SARS-CoV-2 Assay was established using 60 clinical specimens. The positive and negative percent agreements were analyzed by comparing the SARS-CoV-2 Assay results to Seegene's AllplexTM 2019-nCoV which showed 100% concordance. Conclusion(s): This assay demonstrated accuracy and reproducibility for the detection of SARS-CoV-2.Copyright © 2023

Psychometric properties of the online Satisfaction with Life Scale in university students from a low-income region.

PURPOSE: To test the feasibility, reliability, and validity of the Satisfaction with Life Scale (SWLS) in an online format in university students from a low-income region. METHODS: This was a psychometric study, involving a study of reliability (n = 117) and validity (n = 195) in university students from a region with a Gini index of 0.56. The scale was applied at two time points with an interval of 2 weeks. This scale measures satisfaction with life based on five statements and responses ranging from 1 to 7 (strongly disagree to strongly agree). We conducted the reliability assessment using temporal stability and internal consistency and construct validity assessment by internal structure solution. RESULTS: All SWLS items showed acceptable (rho > 0.30) and significant (p < 0.05) temporal stability and acceptable internal consistency (alpha > 0.70). In construct validity (internal structure), we identified a factor with an explained variance of 59.0% in the exploratory factor analysis. Additionally, in the confirmatory factor analysis, we identified a one-factor structure solution for SWLS with an acceptable model fitting (chi-square/degrees of freedom [X2/df] = 6.53; Tucker-Lewis Index [TLI] = 0.991; Comparative Fit Index [CFI] = 0.996; root mean square error of approximation [RMSEA] = 0.040; standardized root mean-squared residual [SRMR] = 0.026). CONCLUSION: The Satisfaction with Life Scale, in the online format, is a reliable and valid tool for university students in a low-income context.

Building a collaborative cloud platform to accelerate heart, lung, blood, and sleep research.

Research increasingly relies on interrogating large-scale data resources. The NIH National Heart, Lung, and Blood Institute developed the NHLBI BioData CatalystⓇ (BDC), a community-driven ecosystem where researchers, including bench and clinical scientists, statisticians, and algorithm developers, find, access, share, store, and compute on large-scale datasets. This ecosystem provides secure, cloud-based workspaces, user authentication and authorization, search, tools and workflows, applications, and new innovative features to address community needs, including exploratory data analysis, genomic and imaging tools, tools for reproducibility, and improved interoperability with other NIH data science platforms. BDC offers straightforward access to large-scale datasets and computational resources that support precision medicine for heart, lung, blood, and sleep conditions, leveraging separately developed and managed platforms to maximize flexibility based on researcher needs, expertise, and backgrounds. Through the NHLBI BioData Catalyst Fellows Program, BDC facilitates scientific discoveries and technological advances. BDC also facilitated accelerated research on the coronavirus disease-2019 (COVID-19) pandemic.

Comparison on the performance of two qPCR instruments in the detection of SARS-CoV-2 virus

Objective To compare the performance of two qPCR instruments in detecting SARS-CoV-2 virus in the nasopharyngeal swab samples of suspected COVID-19 isolated individuals in Jinghu district Wuhu city.Methods A total of 151 nasopharyngeal swab samples were collected from individuals with suspected COVID-19isolated during January 2021 and July 2022 at a quarantine site in the Jinghu district. Nucleic acid of SARS-CoV-2virus was quantified parallelly using ABIQ5 real-time fluorescence quantitative analyzer（Q5 analyzer） and Bole CFX96 fluorescence quantitative PCR analyzer（Bole analyzer） in the laboratory. Q5 analyzer was used as the reference instrument, while Bole analyzer was used as an experimental instrument. The detection results of N gene, ORF1ab fragment and CT value of the two RT-PCR machines were analyzed and compared using paired four grid test, Spearman test and paired sample t-test in SPSS 22 statistical software. Results The results of 151samples for different target genes tested by two instruments were in good agreement（N gene: Kappa=1, P＜0. 05;ORF1ab fragment: Kappa=0. 972, P＜0. 05）. The inter-batch repeatability rates were 4. 01% and 3. 04%for N gene and ORF fragment of the same batch positive quality controls by Q5 analyzer, and were 4. 90% and 3. 57% by Bole analyzer. The intra batch repeatability rates of the two instruments at different hole locations were similar, and CV values were less than 3%. The results of 23 positive samples showed that the differences in CT values of N gene（29. 38±7. 22） and ORF1ab（30. 83±6. 27） detected by Q5 analyzer were statistically significant（t=2. 765, P＜0. 05）, while the differences in CT values of N gene（29. 58±7. 27） and ORF1ab（30. 77±8. 02） detected by Bole analyzer were not statistically significant（t=1. 753, P＞0. 05）. The correlation coefficients of CT values of different target genes detected by the two instruments were rN=0. 960 and rORF=0. 865, showing correlated CT values（P＜0. 05）. Conclusion The CT values of N gene and ORF1ab fragment of SARS-CoV-2 virus detected by the two instruments have strong correlation and agreement, indicating that either of the instrument can be used for laboratory sample detection and analysis. The repeatability of Q5 analyzer is better than that of Bole analyzer. The detection stability of ORF fragments of both instruments is better than that of N gene, and the detection sensitivity of Q5 analyzer for N gene is higher than that for ORF fragment. The sample tubes should be placed in the middle of the PCR machine in order to reduce the system error.

Comparison between in-person and remote assessment of four field tests for people with chronic lung diseases

Introduction: COVID-19 pandemic has driven an abrupt shift from centre-based pulmonary rehabilitation to home-based or telerehabilitation models in order to safely deliver this important treatment. However, functional capacity assessment is still carried out with in-person supervision. Aim(s): To compare remote and in-person assessment of four field tests for patients with chronic lung diseases. Method(s): People with chronic respiratory diseases underwent timed up and go test (TUG), 5-repetitions sit-to-stand test (5-repStS), 1-minute STS (1-minStS), and modified incremental step test (MIST). Tests were carried out at participants' home with in-person or remote (Skype or WhatsApp) assessment, in random order. During the remote assessment, the physiotherapist was at the pulmonary rehabilitation centre. The order of the tests was also randomized and was the same for in-person and remote supervision. Each test was performed twice and the test with best performance was used for comparison between remote and in-person supervision. A kit containing a finger pulse oximeter, tape measure, and a step was provided. Pair t -test expressed as mean difference (95% CI), intraclass correlation coefficient (ICC 2:1), and Bland-Altman method were used for analysis. Result(s): Forty-four participants (23 COPD, 18 bronchiectasis, three cystic fibrosis, FEV 1 47 +/- 19%, 56 +/- 15 years old) were assessed. There was no difference between in-person and remote supervision for all tests (TUG 0.04(-0.2-0.2) s, 5-repStS: 0.3(-0.1-0.7) s, 1-minStS: -0.9 (-1.9-0.1) repetitions, and MIST: -3.1 (-9.9-3.7) steps). High reproducibility was observed by ICC (95% CI) (TUG: 0.94 (0.89-0.97), 5-repStS: 0.96 (0.92-0.98), 1-minStS: 0.87 (0.77-0.93), and MIST: 0.94 (0.88-0.96). Limits of agreement were narrow for TUG (-0.8-1.7), 5-repStS (-2.3-2.9), and 1-minStS (-7.4-5.5), but wide for MIST (-46-40). Conclusion(s): Remote assessment provides similar results to in-person assessment for four field tests commonly used in people with chronic lung diseases.

Verification of the Performance of the Panbio COVID-19 Ag Rapid Test Device for Implementation in the Clinical Laboratory

Objectives: The Panbio COVID-19 Ag Rapid Test Device (Panbio COVID-19 Ag, Abbott Rapid Diagnostics) is a lateral flow immunochromatographic assay targeting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleoprotein in nasopharyngeal specimens for the diagnosis of coronavirus disease 2019 (COVID-19). This study aimed to verify the performance of the Panbio COVID-19 Ag for implementation in clinical laboratories. Method(s): Sixty nasopharyngeal swab specimens (30 positive and 30 negative) dipped in transport medium, and COVID-19 was confirmed using real-time RT-PCR using Allplex SARS-CoV-2 assay (Seegene), were tested using the Panbio COVID-19 Ag. Reproducibility was evaluated using positive and negative control materials. Sensitivity and specificity were calculated based on the results of realtime RT-PCR as the standard test method. Result(s): Reproducibility was confirmed by the consistent results of repeated tests of the quality control materials. The overall sensitivity and specificity of Panbio COVID-19 Ag were 50.0% and 100.0%, respectively. Panbio COVID-19 Ag demonstrated high sensitivity (88.2%) in analyzing the detection limit cycle threshold (Ct) value of 26.67 provided by the manufacturer as a positive criterion, and the sensitivity was 100.0% for the positive criterion of Ct values <25, although it was less sensitive for Ct > 25. Conclusion(s): Considering the high sensitivity for positive samples with Ct values <25 and the rapid turnaround of results, Panbio COVID-19 Ag can be used in clinical laboratories to diagnose COVID-19 in limited settings. Copyright © 2023 Ewha Womans University College of Medicine and Ewha Medical Research Institute.

Transparency in infectious disease research: meta-research survey of specialty journals.

BACKGROUND: Infectious diseases carry large global burdens and have implications for society at large. Therefore, reproducible, transparent research is extremely important. METHODS: We evaluated transparency indicators (code and data sharing, registration, conflict and funding disclosures) in the 5340 PubMed Central Open Access articles published in 2019 or 2021 in the 9 most-cited specialty journals in infectious disease using the text-mining R package, rtransparent. RESULTS: 5340 articles were evaluated (1860 published in 2019 and 3480 in 2021 (of which 1828 on COVID-19)). Text-mining identified code sharing in 98 (2%) articles, data sharing in 498 (9%), registration in 446 (8%), conflict of interest disclosures in 4209 (79%) and funding disclosures in 4866 (91%). There were substantial differences across the 9 journals: 1-9% for code sharing, 5-25% for data sharing, 1-31% for registration, 7-100% for conflicts of interest, and 65-100% for funding disclosures. Validation-corrected imputed estimates were 3%, 11%, 8%, 79% and 92%, respectively. There were no major differences between articles published in 2019 and non-COVID-19 articles in 2021. In 2021, non-COVID-19 articles had more data sharing (12%) than COVID-19 articles (4%). CONCLUSIONS: Data sharing, code sharing, and registration are very uncommon in infectious disease specialty journals. Increased transparency is required.

Impact of body mass index on the reliability of the CT0–4 grading system: a comparison of computed tomography protocols

Background: The increased frequency of chest computed tomography utilization in the fight against COVID-19 has made usage of low-dose computed tomography necessary to reduce the radiation dose while preserving diagnostic quality. However, in the published literature, there were no data on the effect of body mass index on low-dose computed tomography accuracy in patients with COVID-19. Aim: To assess the effect of patient body mass index on the level of agreement between radiologists interpreting standard-dose computed tomography and low-dose computed tomography in COVID-19-associated pneumonia using visual semiquantitative CT 0–4 scale. Materials and methods: In this retrospective multicenter study, each participant underwent two consecutive chest scans at a single visit using standard-dose and low-dose protocols. Standard-dose and low-dose computed tomography with pulmonary and soft tissue kernels were interpreted using a visual semiquantitative CT 0–4 grading system. Data for each protocol were grouped by body mass index value (threshold value for pathology was equal to 25 kg/m2). Agreement was calculated based on binary and weighted classifications. One-way ANOVA analysis of variance was used to assess the presence of statistically significant differences in the mean for the groups. Results: Two hundred thirty patients met the established inclusion criteria for the study. The experts processed 4 studies for each patient: standard-dose and low-dose computed tomography with pulmonary and soft tissue kernels. The proportion of normal-weight patients was 31% (71 subjects), and the sample's median body mass index was 27.5 (18.3;48.3) kg/m2. There were no statistically significant differences in intergroup pairwise comparisons for both the binary and weighted classifications (p values were 0.09 and 0.12, respectively). The group of overweight patients was further subdivided according to the degrees of obesity;however, the results were invariant to this division (no statistically significant differences: for the most different body mass index groups "normal” and "3rd degree obesity” p-value 0.17). Conclusion: Body mass index does not affect chest standard-dose and low-dose computed tomography interpretation in COVID-19 using the visual semiquantitative CT 0–4 grading system. © Authors, 2022.

Evaluation of the EUROIMMUN Aspergillus antigen immunoenzyme assay in serum and bronchoalveolar lavage fluid samples

Introduction: The most widely used marker for the diagnosis of invasive aspergillosis (IA) is the detection of galactomannan by ELISA. This study describes the evaluation of the results obtained by Euroimmun Aspergillus antigen ELISA (EIA-GM-E) in serum samples and bronchoalveolar lavage fluid (BAL) from patients at risk of IA, and compares these results with those obtained by Bio-Rad Galactomannan EIA (EIA-GM-BR). Method(s): Anonymous retrospective case-control comparative study in 64 serum samples and 28 BAL from 51 patients. Result(s): Overall agreement of the results of the two assays was observed in 72 of 92 samples (78.3%). The sensitivity of EIA-GM-BR and EIA-GM-E in serum samples was 88.9% and 43.2%, respectively, and 100% and 88.9% for BAL. The specificity of EIA-GM-BR and EIA-GM-E in serum samples was 91.9% for both assays, and 68.4% and 84.2% in BAL. There were no statistically significant differences in the results of both assays. Conclusion(s): Both methods show good results for the discrimination of patients with IA when BAL is tested, or serum in case of EIA-GM-BR.Copyright © 2021 Sociedad Espanola de Enfermedades Infecciosas y Microbiologia Clinica

Evaluation of a new lateral flow assay for the quantitative detection of Anti-SARS- CoV- 2 specific IgG

Background: Antibody testing for COVID-19 may represent an interesting tool to document past SARS-CoV- 2 infections, both in individual patients with suspected COVID-19 symptoms or late-stage complications who had no (conclusive) PCR test. In addition, measuring SARS-CoV- 2 antibodies may offer a prognostic value and convey information on protective immunity in vaccination trials. The objective of the study is the evaluation of a rapid test for the quantitative interpretation of Anti-SARS- CoV- 2 IgG compared with other in-vitro methods. Method(s): The Anti-SARS- CoV- 2 LFA (Lateral Flow Assay) is a rapid test for the quantitative measurement of IgG antibodies to SARS-CoV- 2 in human serum, plasma and whole blood within 20 minutes. The complexes of Anti-SARS- CoV- 2 antibodies from patient's sample and coloured conjugate are retained at the test line by the complete SARS-CoV- 2 Spike Protein. The use of a special scanner system provides the opportunity of quantitative interpretation of the results, by using calibration curve established with "First WHO International Standard for anti-SARS- CoV- 2 immunoglobulin (human)". Result(s): Serum samples were taken from the serum bank at Dr. Fooke Laboratorien GmbH and tested for Anti-SARS- CoV- 2 IgG by the newly developed LFA (Dr. Fooke Laboratorien GmbH). The results were compared with established assay methods like Anti-SARS- CoV- 2 ELISA IgG (Dr. Fooke Laboratorien GmbH and Euroimmun). Good agreements were observed. Sensitivity and specificity between the newly developed LFA and Anti-SARS- CoV- 2 ELISA IgG of Dr. Fooke / Euroimmun were found at 0.95/0.88 and 1.00/0.93, respectively. The calibration curve established with "First WHO International Standard for anti-SARS- CoV- 2 immunoglobulin (human)" shows a reproducibility of > 90%. Conclusion(s): The Anti-SARS- CoV- 2 LFA shows comparable results to the ELISA systems of Dr. Fooke Laboratorien and Euroimmun. By the use of small amounts of serum, plasma or whole blood (10muL) the patients receive a fast and reliable result. A calibration curve, established with "First WHO International Standard for anti-SARS- CoV- 2 immunoglobulin (human)" offers the comparability to quantitative ELISA systems.

A novel isothermal digital amplification system and its application for absolute quantification of respiratory infectious virus

Herein, we establish a novel isothermal digital amplification system termed digital nicking and extension chain reaction system-based amplification (dNESBA) by utilizing the isothermal NESBA technique and the newly developed miniaturized fluorescence monitoring system (mFMS). dNESBA enables parallel isothermal NESBA reactions in more than 10,000 localized droplet microreactors and read the fluorescence signals rapidly in 150 s by mFMS. This system could identify the genomic RNA (gRNA) extracted from target respiratory syncytial virus A (RSV A) as low as 10 copies with remarkable specificity. The practical applicability of dNESBA was also successfully verified by reliably detecting the gRNA in the artificial sputum samples with excellent reproducibility and accuracy. Due to the intrinsic advantages of isothermal amplifying technique including the elimination of the requirement of thermocycling device and the enhanced portability of the miniaturized read-out equipment, the dNESBA technique equipped with mFMS could serve as a promising platform system to achieve point-of-care (POC) digital molecular diagnostics, enabling absolute and ultra-sensitive quantification of various infectious pathogens even in an early stage.Copyright © 2023

Rigor, Reproducibility, and Transparency in Shared Research Resources: Follow-Up Survey and Recommendations for Improvements.

Rigor, reproducibility, and transparency (RR&T) are essential components of all scientific pursuits. Shared research resources, also known as core facilities, are on the frontlines of ensuring robust RR&T practices. The Association of Biomolecular Resource Facilities Committee on Core Rigor and Reproducibility conducted a follow-up survey 4 years after the initial 2017 survey to determine if core facilities have seen a positive impact of new RR&T initiatives (including guidance from the National Institutes of Health, new scientific journal requirements on transparency and data provenance, and educational tools from professional organizations). While there were fewer participants in the most recent survey, the respondents' opinions on the role of core facilities and level of best practices adoption remained the same. Overall, the respondents agreed that procedures should be implemented by core facilities to ensure scientific RR&T. They also indicated that there is a strong correlation between institutions that emphasize RR&T and core customers using this expertise in grant applications and publications. The survey also assessed the impact of the COVID-19 pandemic on core operations and RR&T. The answers to these pandemic-related questions revealed that many of the strategies aimed at increasing efficiencies are also best practices related to RR&T, including the development of standard operating procedures, supply chain management, and cross training. Given the consistent and compelling awareness of the importance of RR&T expressed by core directors in 2017 and 2021 contrasted with the lack of apparent improvements over this time period, the authors recommend an adoption of RR&T statements by all core laboratories. Adhering to the RR&T guidelines will result in more efficient training, better compliance, and improved experimental approaches empowering cores to become "rigor champions."

Motivation to Correct Misinformation: Third-Person Perceptions and Perceived Norms

The proliferation of misinformation is an ongoing problem in the United States. The public's trust in news from the mainstream media is down, and the sharing of news items on social media is up—even the sharing of made-up news. Previous research has found third-person perceptions (TPP) indicate that people tend to believe that others are more influenced by misinformation than they are. People also believe they are more likely to correct their own misinformation than their perceived norm of how likely others are to correct misinformation that they have propagated. This replication study found that TPP and perceived norms influence a person's likelihood of self-correcting and correcting others when misinformation has been spread. Those with lower media hostility are also more likely to correct.

From 2020 Home BP Consensus to 2022 TSOC/THS Hypertension Guideline

Background: Hypertension is the most important modifiable cause of cardiovascular (CV) disease and all-cause mortality worldwide. Numerous epidemiological studies and pharmacological intervention trials have demonstrated that lower and lowering blood pressures (BP) are associated with fewer CV events and lower mortality. Despite the positive correlations between BP levels and later CV events are continuous since BP levels as low as 90/60 mmHg in almost all large-scale epidemiological studies, the diagnostic criteria of hypertension and BP thresholds and targets of antihypertensive therapy have largely remained at the level of 140/90 mmHg in the past 30 years (since the release of the Fifth Report of the Joint National Committee [JNC 5] on high BP in 1993). The publication of both the SPRINT and the STEP trials (comprising >8,500 Caucasian/African and Chinese participants, respectively) provides enough evidence to shake this 140/90 mmHg dogma. In both trials, lowering systolic BP (SBP) to <130 mmHg, compared to the traditional SBP target of <140 (130-139) mmHg, was consistently associated with a 25-30% relative risk reduction in CV events. Another dogma regarding hypertension management is "office (or clinic) BP measurements" Although standardized office BP measurement has been widely recommended, the practice of office BP measurements is hard to be or has never been ideal in real-world practice. Further, the debate regarding the numerical equivalence between automated office BP (AOBP) measurements adopted in the SPRINT trial and office BP measurements has never been settled. The variations of office BP readings and the differences between office BP and home BP readings bewilder not only patients, but also healthcare professionals. On the other hand, out-of-office BP monitoring receives growing attention in contemporary hypertension guidelines. Home BP monitoring (HBPM) and ambulatory BP monitoring (ABPM) are two recognized approaches to obtaining out-of-office BP. HBPM is easy-to-use, more likely to be free of environmental and/or emotional stress (such as white-coat effect), feasible to document long-term BP variations, of good reproducibility and reliability, and more correlated with hypertension-mediated organ damage (HMOD) and CV events. Methods/Results: The Taiwan Hypertension Society (THS) and the Taiwan Society of Cardiology (TSOC) jointly issued the Consensus Statement on HBPM in 2020. The "722" protocol to standardize HBPM has been advocated by both Societies and widely accepted by healthcare professionals. In the 2022 Taiwan Hypertension Guidelines, we break the dogma of "office BP-based management strategy" and further expand the role of HBPM to the whole hypertension management process, from diagnosis to long-term follow-up. The Task Force considers that, to improve the quality of long-term management of all chronic diseases including hypertension, patients themselves should take an active role and HBPM is the right tool to achieve this goal, regardless of many other advantages of HBPM. This approach is of particularly importance in the post-COVID era and can bridge the management with artificial intelligence technologies. Conclusion(s): To facilitate implementation of the guidelines, a series of flowcharts to encompass assessment, adjustment, and HBPM-guided hypertension management are provided.

Establishment and application of a triplex RT-PCR method for detection of PDCoV, SADS-CoV, and SVA

[Background] Porcine delta coronavirus（PDCoV）, swine acute diarrhea syndrome coronavirus（SADS-CoV）, and Seneca virus A（SVA） are new pathogens which seriously endanger the development of pig industry. The clinical symptoms of pigs infected with the three pathogens are difficult to distinguish. Therefore, it is urgent to establish a multiplex RT-PCR detection method for rapid diagnosis of suspected pigs and reduce economic losses. [Objective] To establish a triplex RT-PCR method for simultaneous detection of single or mixed infection of PDCoV, SADS-CoV, and SVA. [Methods] Three pairs of specific primers were designed according to the conserved regions of the N genes of PDCoV and SADS-CoV and the L/P1 genes of SVA registered in GenBank, and the optimal annealing temperature（Tm） was determined by temperature gradient PCR method. The primer concentration was optimized by array method. The recombinant plasmids PMD-PDCoV, PMD-SADS-CoV,and PMD-SVA were constructed as standards to determine the limits of detection（LOD）. The specificity of the triplex RT-PCR method was determined with the nucleic acid samples of 6 common pig viruses including porcine transmissible gastroenteritis virus, porcine epidemic diarrhea virus, and porcine reproductive and respiratory syndrome virus. The repeatability of the established method was verified by inter-batch and intra-batch tests. Finally, we employed the triplex RT-PCR method to detect the clinical samples suspected of infection and compared the results with those obtained with the reported detection methods, thus evaluating the clinical application performance of the method. [Results] The optimal Tm was 58.3 ℃, and the optimal primer concentrations were 0.5 μmol/L, 0.25 μmol/L, and 0.25 μmol/L,respectively. The established method had high sensitivity, with the LODs of 1 copy/μL, 1 copy/μL, and 10 copies/μL for PMD-PDCoV, PMD-SADS-CoV, and PMD-SVA, respectively. It had strong specificity, with specific bands only for PDCoV, SADS-CoV, and SVA and no bands for other viruses.Moreover, the method had good repeatability as the test results were consistent between and within batches. The positive rates of PDCoV, SADS-CoV, and SVA in the clinical samples detected by the established method were 65.85%, 30.49%, and 57.32%, respectively, which were consistent with the results obtained with the reported detection methods. Finally, 5 samples were randomly selected from 13 positive samples of PDCoV, SADS-CoV, and SVA for sequencing, and the phylogenetic tree indicated that the PCR amplification sequences of the five positive samples had high homology（above 96%） between each other and also with the reference sequences. [Conclusion] The triplex RT-PCR method established in this study is accurate and reliable for the simultaneous detection of PDCoV,SADS-CoV, and SVA in clinical samples.

Post-COVID-19 perceived stigma-discrimination scale: psychometric development and evaluation

The study aimed to adapt and evaluate a scale to measure COVID-19-CED in COVID-19 survivors. A sample of 330 COVID-19 survivors filled out the COVID-19 Perceived Discrimination Scale (C-19-PDS). C-19-PDS was adapted from the Tuberculosis Perceived Discrimination Scale (11 items). Confirmatory factor analysis showed poor goodness-of-fit indicators. However, the 5-item version of the C-19-PDS showed better goodness-of-fit indicators, high internal consistency, and non-gender DIF. This instrument is recommended to evaluate COVID-19-CED in Colombian and other Spanish-speaking populations.