Extending the Grading of Recommendations Assessment, Development and Evaluation (GRADE) in Traditional Chinese Medicine (TCM): The GRADE-TCM.

AIM: To extend and form the "Grading of Recommendations Assessment, Development and Evaluation in Traditional Chinese Medicine" (GRADE-TCM). METHODS: Methodologies were systematically reviewed and analyzed concerning evidence-based TCM guidelines worldwide. A survey questionnaire was developed based on the literature review and open-end expert interviews. Then, we performed expert consensus, discussion meeting, opinion collection, external examination, and the GRADE-TCM was formed eventually. RESULTS: 265 Chinese and English TCM guidelines were included and analyzed. Five experts completed the open-end interviews. Ten methodological entries were summarized, screened and selected. One round of consensus was conducted, including a total of 22 experts and 220 valid questionnaire entries, concerning 1) selection of the GRADE, 2) GRADE-TCM upgrading criteria, 3) GRADE-TCM evaluation standard, 4) principles of consensus and recommendation, and 5) presentation of the GRADE-TCM and recommendation. Finally, consensus was reached on the above 10 entries, and the results were of high importance (with voting percentages ranging from 50 % to 81.82 % for "very important" rating) and strong reliability (with the Cr ranging from 0.93 to 0.99). Expert discussion meeting (with 40 experts), opinion collection (in two online platforms) and external examination (with 14 third-party experts) were conducted, and the GRADE-TCM was established eventually. CONCLUSION: GRADE-TCM provides a new extended evidence-based evaluation standard for TCM guidelines. In GRADE-TCM, international evidence-based norms, characteristics of TCM intervention, and inheritance of TCM culture were combined organically and followed. This is helpful for localization of the GRADE in TCM and internationalization of TCM guidelines.

Spatiotemporal pattern evolution and influencing factors of online public opinion--Evidence from the early-stage of COVID-19 in China.

With the rapid development of internet information technology, online public opinion's influence is infinitely magnified, seriously threatening social security and national governance. It is significant to clarify the spatial and temporal evolution rules of online public opinion on major epidemics and its influencing factors for the governance and guidance of online public opinion on major epidemics. In this paper, the spatiotemporal evolution analysis model of online public opinion and an analysis model of influencing factors were constructed. We selected the Baidu index and microblog crawler text data at the early stage of COVID-19 as the research objects and analyzed the evolution of online public opinion during the time period by using the optimal segmentation method, spatial autocorrelation analysis, and text analysis method. The spatiotemporal evolutionary influences and their influence are further analyzed using the geographic probe factor detection method. The results showed that the evolution of online public opinion in the early stage of the epidemic was closely related to the event's evolution and the prevention and control effect. In the time dimension, the early evolution of online public opinion has prominent periodic characteristics. In the geospatial dimension, there are significant spatial agglomeration effects and spillover effects. In the cyberspace dimension, there are significant differences in online public opinion heat, hot topics, and netizens' emotional tendencies at different stages. Furthermore, the severity of the epidemic, the number of Internet users, the number of media reports and the region's attributes jointly affect the spatial and temporal evolution pattern of online public opinions about the epidemic. The research results provide decision-making references for the government and planners to effectively manage online public opinion on emergencies and improve the government's public opinion governance capacity and level.

Correlation of Serum Clara Cell Secretory Protein 16, Plasma Fibrinogen and Serum Amyloid A with the Severity of Acute Exacerbated COPD and Their Combination in Prognosis Assessment.

Introduction: Chronic obstructive pulmonary disease (COPD) has tremendous detrimental effects on patients' quality of life, lung function, disease progression and socioeconomic burden. This study aimed to investigate new serum biomarkers for COPD detection. Three recently emerging biomarkers, including Clara cell secretory protein⁃16 (CC16), plasma fibrinogen (FIB) and serum amyloid A (SAA), were investigated for their potential in stratifying the severity of COPD. Methods: A total of 220 patients with AECOPD were recruited. Multivariate logistical regression was used to analyze odds ratios of an array of characteristic of patients, including age, global initiative for chronic obstructive lung disease (GOLD), diabetes mellitus, heart diseases, PaCO2, CC16, FIB, and SAA. Correlations of CC16, FIB and SAA levels to each other, GOLD, and PaCO2 were also measured using Spearman correlation. Receiver operating characteristic (ROC)/curve analysis was used to assess sensitivity and specificity of CC16, FIB, SAA and the combination of the three markers in identifying AECOPD patients with poor prognosis. Results: Our data suggested that age, GOLD, diabetes mellitus, heart diseases, PaCO2, CC16, FIB, and SAA are all significant risk factors for poor prognosis of AECOPD. CC16, FIB and SAA were positively correlated to each other and to GOLD and PaCO2 levels. CC16, FIB and SAA all had a high sensitivity and specificity in identifying patients with a poor prognosis. CC16, FIB and SAA are new markers with potentially high predictive value in AECOPD. Discussion: Our data support further development of these biomarkers to improve clinical management of AECOPD through providing more accurate prognosis of AECOPD patients that enable timely adjustment of treatment plans.

The Diagnostic and Assessment Value of Plasma Pentraxin 3 in Acute Exacerbation of Chronic Obstructive Pulmonary Disease.

Background: Pentraxin 3 (PTX3) is an acute-phase protein and an important inflammatory mediator. We hypothesized plasma PTX3 could be a valuable diagnostic biomarker in acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods: In this prospective controlled study, 458 COPD patients and 71 healthy controls from May 2019 to December 2020 in two hospitals were enrolled. COPD patients were divided into AECOPD group (n = 173) and stable COPD group (n = 285). AECOPD patients were subdivided into mild or moderate group (n = 43) and severe group (n = 130) based on severity. Plasma PTX3 levels were detected by ELISA. Results: Plasma PTX3 levels were significantly higher in AECOPD (2.8 ng/mL) compared to stable COPD (0.87 ng/mL) and healthy controls (0.83 ng/mL). In the analysis of AECOPD subgroups, plasma PTX3 level of severe group (4.51 ng/mL) was significantly higher than that of mild or moderate group (1.25 ng/mL). Patients with respiratory failure had higher PTX3 than those without respiratory failure. No difference was observed between stable COPD patients and healthy controls. ROC analysis showed that plasma PTX3 had a considerable ability to distinguish AECOPD from stable COPD [AUC: 0.85, 95% CI (0.81-0.88), P < 0.0001; cut-off 1.25 ng/mL, sensitivity 77.5%, specificity 74%]. AUC of PTX3 was better than CRP regarding diagnosis of AECOPD. Combination of PTX3 and CRP was superior to either of them in diagnosing AECOPD. Conclusion: Plasma PTX3 levels were significantly higher in AECOPD than stable COPD. The level was associated with the severity of exacerbation. Plasma PTX3 has potential value as a biomarker to diagnose and evaluate AECOPD.

Assessment of dynamic drought-induced ecosystem risk: Integrating time-varying hazard frequency, exposure and vulnerability.

Terrestrial ecosystems, occupying 28.26% of Earth's surface, are extensively at risk from droughts, which is likely to propagate into human communities owing to loss of vital services. Ecosystem risk also tends to fluctuate within anthropogenically-forced nonstationary environments, raising considerable concerns about effectiveness of mitigation strategies. This study aims to assess dynamic ecosystem risk induced by droughts and identify risk hotspots. Bivariate nonstationary drought frequency was initially derived as a hazard component of risk. By coupling vegetation coverage and biomass quantity, a two-dimensional exposure indicator was developed. Trivariate likelihood of vegetation decline was calculated under arbitrary droughts to intuitively determine ecosystem vulnerability. Ultimately, time-variant drought frequency, exposure and vulnerability were multiplied to derive dynamic ecosystem risk, followed by hotspot and attribution analyses. Risk assessment implemented in the drought-prevalent Pearl River basin (PRB) of China during 1982-2017 showed that meteorological droughts in eastern and western margins, although less frequent, were prolonged and aggravated in contrast to prevalence of less persistent and severe droughts in the middle. In 86.12% of the PRB, ecosystem exposure maintains high levels (0.62). Relatively high vulnerability (>0.5) occurs in water-demanding agroecosystems, exhibiting a northwest-southeast-directed extension. A 0.1-degree risk atlas unveils that high and medium risks occupy 18.96% and 37.99% of the PRB, while risks are magnified in the north. The most pressing hotspots with high risk continuing to escalate reside in the East River and Hongliu River basins. Our results provide knowledge of composition, spatio-temporal variability and driving mechanism of drought-induced ecosystem risk, which will assist in risk-based mitigation prioritization.

[Distribution Characteristics and Risk Assessment of Microplastics in Water of Different Functional Parks in Guilin].

The water environment capacity of urban parks is small, and their self-purification ability is poor. They are also more likely to be affected by microplastics (MPs), which cause an imbalance of the water micro-ecosystem. Based on the functional characteristics of parks (comprehensive park, community park, and ecological park), this study investigated the distribution characteristics of MPs in the water of Guilin parks through spot sampling, microscopic observation, and Fourier transform infrared spectroscopy. In addition, the pollution risk index and the pollution load index were used to evaluate the pollution risk of MPs.The results showed that the abundances of MPs in the park surface water and sediments ranged from 104.67-674.44 n·m-3 and 95.57-877.78 n·kg-1, respectively. There were four main shape types of MPs:fragments, fibers, films, and particles. MPs were dominated by fragments and fibers with small sizes (<1 mm). The polymers of MPs were polyethylene and polyethylene terephthalate. There were significant differences in the abundance of MPs in the water of different functional parks, and the abundance of MPs in comprehensive parks was the highest. The abundance of MPs in park water was closely related to the function of the park and the number of people entering the park. The pollution risk of MPs in the surface water of Guilin parks was low, whereas the pollution risk of MPs in sediments was relatively high. The results of this study indicated that tourism was an important source of MPs pollution in the water of Guilin City parks. The pollution risk of MPs in the water of Guilin City parks was mild. However, the pollution risk of MPs accumulated in small freshwater waters of urban parks requires continued attention.

Assessment of Transcatheter or Surgical Closure of Atrial Septal Defect using Interpretable Deep Keypoint Stadiometry.

Automated echocardiogram interpretation with artificial intelligence (AI) has the potential to facilitate the serial diagnosis of heart defects by primary clinician. However, the fully automated and interpretable analysis pipeline for suggesting a treatment plan is largely underexplored. The present study targets to build an automatic and interpretable assistant for the transthoracic echocardiogram- (TTE-) based assessment of atrial septal defect (ASD) with deep learning (DL). We developed a novel deep keypoint stadiometry (DKS) model, which learns to precisely localize the keypoints, i.e., the endpoints of defects and followed by the absolute distance measurement with the scale. The closure plan and the size of the ASD occluder for transcatheter closure are derived based on the explicit clinical decision rules. A total of 3,474 2D and Doppler TTE from 579 patients were retrospectively collected from two clinical groups. The accuracy of closure classification using DKS (0.9425 ± 0.0052) outperforms the "black-box" model (0.7646 ± 0.0068; p < 0.0001) for within-center evaluation. The results in cross-center cases or using the quadratic weighted kappa as an evaluation metric are consistent. The fine-grained keypoint label provides more explicit supervision for network training. While DKS can be fully automated, clinicians can intervene and edit at different steps of the process as well. Our deep learning keypoint localization can provide an automatic and transparent way for assessing size-sensitive congenital heart defects, which has huge potential value for application in primary medical institutions in China. Also, more size-sensitive treatment planning tasks may be explored in the future.

Impact of HPV vaccination on HPV infection and cervical related disease burden in real-world settings (HPV-RWS): protocol of a prospective cohort.

BACKGROUND: Cervical cancer is one of the most common cancers in women and could be prevented by human papilloma virus (HPV) vaccination. Cervarix, the first available HPV vaccine, has been widely administrated to Chinese women, while little was known about its effect on the prevention and control for HPV related diseases in China. The study aims to assess the impact of Cervarix on HPV infection and cervical related diseases in real world. METHODS: This is a prospective, multi-age birth cohort study to investigate the incidence and continuous status of HPV infection, and relevant cervical diseases by exposure status (with Cervarix vaccination history or without any HPV vaccination history). It is planned to recruit 12,118 eligible women at age of 9 to 45 years from vaccination clinics or hospital outpatient clinics, and then follow up them for three years. The standard questionnaire will be used to collect information such as demographic characteristics, menstruation and obstetrical histories, history of sexual behavior, personal behavior history, history of disease and pathogen infection, medication history, and family history at baseline. After three years, the changes of these behaviors will be investigated again, and other related health status information will be retrieved from the electronic health records during the follow-up period. If available physically and legally, the cervical cancer screening will be performed, including type-specific HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) testing and contingent thinprep cytologic test (TCT) and colposcopy. The free cervical cancer screening will be captured and uploaded timely to the Yinzhou Regional Health Information Platform (YRHIP); therefore, the long-term outcomes of participants will be monitored. DISCUSSION: This prospective cohort study will assess the impact of HPV vaccine on HPV infection and related cervical diseases in women aged 9-45 years, which makes up for the lack of evidence in Chinese women. The results of this study will provide support for understanding the impact of HPV vaccination in China, and make a contribution to increasing HPV vaccination and cervical cancer screening coverage in China. TRIAL REGISTRATION: This study has been retrospectively registered on clinicaltrials.gov (NCT05341284) on April 22, 2022.

Leader's strategies for designing the promotional path of regional brand competitiveness in the context of economic globalization.

In the era of economic globalization, the competitiveness of products on a global scale is increasingly achieved through effective and sustainable strategies for brand development by the leaders. This paper conducts an empirical study on regional brand competitiveness (BC) influencing factors. A research model was proposed and tested by employing structural equation modeling. Data analysis was conducted using 214 valid questionnaires from two major producing areas in Jilin Province, China. Research results show that Brand Market (BM) and Government Guidance (GG) directly and positively impact the regional BC. Regional Resource (RR) and industrial development (ID) indirectly impact the regional BC through the mediating role of BM and GG. BM is the most important factor affecting the regional BC. Based on this, the path to improve the competitiveness of traditional agricultural products under economic globalization is determined, and targeted countermeasures and suggestions are formulated for the existing problems.

Cost-effectiveness analysis of colorectal cancer screening in Shanghai, China: A modelling study.

Background: The current community-based colorectal cancer (CRC) screening program in Shanghai, launched in 2013, invited individuals aged 50-74 years to triennial screening with a qualitative faecal immunochemical test (FIT) and questionnaire-based risk assessment (RA). We aimed to evaluate the effectiveness and cost-effectiveness of the existing Shanghai screening program and compare it to using a validated two-sample quantitative FIT. Methods: We simulated four strategies (no screening, Shanghai FIT, Shanghai FIT + RA and validated FIT) for the Shanghai screening program and evaluated CRC incidence, CRC mortality, the number of life years gained (LYG), the number of FITs, and colonoscopies required for each. An incremental cost-effectiveness analysis was performed to assess the cost- effectiveness of each strategy. Results: All screening modalities reduced CRC incidence and CRC mortality, gained extra number of LYG compared to no screening. Screening using the Shanghai FIT and validated FIT reduced CRC incidence from 45 cases to 43 per 1,000 simulated individuals (4.4%). Incidence was reduced to 42 cases (6.7%) using the Shanghai FIT + RA. All screening strategies reduced CRC mortality by 10.0% (from 10 to 9 deaths) and resulted in 6 to 7 LYG. The validated FIT was the most cost-effective among the evaluated strategies (ICER ¥26,461 per LYG). Conclusions: Our findings show that the current Shanghai screening program is (cost-) effective compared to no screening, but changing to a validated FIT would make the program more efficient.

Development and Assessment of the Validity and Reliability of the Short-Form Life Satisfaction Index (LSI-SF) among the Elderly Population.

BACKGROUND: Elderly care should focus on not only prolonging life but also satisfaction with elderly life. Our study investigated the reliability and validity of the Short-Form Life Satisfaction Index (LSI-SF). METHOD: Data were drawn from the 2015 Taiwan Longitudinal Study on Aging. Internal consistency reliability was used to confirm that the items measured the targeted characteristics. Construct validity was established by confirmatory factor analysis (CFA). Criterion-related validity was examined with the WHO-5 Well-Being Index as an indicator of quality of life. Known-group validity was determined from the difference between frailty stage and quality of life. RESULTS: The high consistency reliability supported the reliability of the LSI-SF. Rigorous CFA validated the construct validity of the LSI-SF. Perfect convergent and discriminant validity supported the validity of the LSI-SF. In addition, there was a significant correlation between the LSI-SF and the WHO-5 Well-Being Index. The LSI-SF appears to be a reliable measure of quality of life in the elderly. We found that frailty status was associated with lower life satisfaction, which supported the known-group validity. Life satisfaction was highest in the non-frailty stage and lowest in the frailty stage. CONCLUSIONS: The LSI-SF appears to be a valid and reliable measure of satisfaction with elderly life.

Optimising colorectal cancer screening in Shanghai, China: a modelling study.

INTRODUCTION: To reduce the burden of colorectal cancer (CRC) in Shanghai, China, a CRC screening programme was commenced in 2013 inviting those aged 50-74 years to triennial screening with a faecal immunochemical test (FIT) and risk assessment. However, it is unknown whether this is the optimal screening strategy for this population. We aimed to determine the optimal CRC screening programme for Shanghai in terms of benefits, burden, harms and cost-effectiveness. METHODS: Using Microsimulation Screening Analysis-Colon (MISCAN-Colon), we estimated the costs and effects of the current screening programme compared with a situation without screening. Subsequently, we estimated the benefits (life years gained (LYG)), burden (number of screening events, colonoscopies and false-positive tests), harms (number of colonoscopy complications) and costs (Renminb (¥)) of screening for 324 alternative screening strategies. We compared several different age ranges, screening modalities, intervals and FIT cut-off levels. An incremental cost-effectiveness analysis determined the optimal strategy assuming a willingness-to-pay of ¥193 931 per LYG. RESULTS: Compared with no screening, the current screening programme reduced CRC incidence by 40% (19 cases per 1000 screened individuals) and CRC mortality by 67% (7 deaths). This strategy gained 32 additional life years, increased colonoscopy demand to 1434 per 1000 individuals and cost an additional ¥199 652. The optimal screening strategy was annual testing using a validated one-sample FIT, with a cut-off of 10 µg haemoglobin per gram from ages 45 to 80 years (incremental cost-effectiveness ratio, ¥62 107). This strategy increased LY by 0.18% and costs by 27%. Several alternative cost-effective strategies using a validated FIT offered comparable benefits to the current programme but lower burden and costs. CONCLUSIONS: Although the current screening programme in Shanghai is effective at reducing CRC incidence and mortality, the programme could be optimised using a validated FIT. When implementing CRC screening, jurisdictions with limited health resources should use a validated test.

Preliminary Study on Quantitative Assessment of the Fetal Brain Using MOLLI T1 Mapping Sequence.

BACKGROUND: Prenatal quantitative evaluation of myelin is important. However, few techniques are suitable for the quantitative evaluation of fetal myelination. PURPOSE: To optimize a modified Look-Locker inversion recovery (MOLLI) T1 mapping sequence for fetal brain development study. STUDY TYPE: Prospective observational preliminary cohort study. POPULATION: A total of 71 women with normal fetuses divided into mid-pregnancy (gestational age 24-28 weeks, N = 25) and late pregnancy (gestational age > 28 weeks, N = 46) groups. FIELD STRENGTH/SEQUENCE: A 3 T/MOLLI sequence. ASSESSMENT: T1 values were measured in pedunculus cerebri, basal ganglia, thalamus, posterior limb of the internal capsule, temporal white matter, occipital white matter, frontal white matter, and parietal white matter by two radiologists (11 and 16 years of experience, respectively). STATISTICAL TESTS: The Kruskal-Wallis test was used for reginal comparison. For each region of interest (ROI), differences in T1 values between the mid and late pregnancy groups were assessed by the Mann Whitney U test. Pearson correlation coefficients (r) were used to evaluate the correlations between T1 values and gestational age for each ROI. Intraobserver and interobserver agreement was determined by the intraclass correlation coefficient (ICC). A P value <0.05 was considered statistically significant. RESULTS: Interobserver and intraobserver agreements of T1 were good for all ROIs (all ICCs > 0.700). There were significant differences in T1 values between lobal white matter and deep regions, respectively. Significant T1 values differences were found between middle and late pregnancy groups in pedunculus cerebri, basal ganglion, thalamus, posterior limb of the internal capsule, temporal, and occipital white matter. The T1 values showed significantly negative correlations with gestational weeks in pedunculus cerebri (r = -0.80), basal ganglion (r = -0.60), thalamus (r = -0.68), and posterior limb of the internal capsule (r = -0.77). DATA CONCLUSION: The T1 values of fetal brain may be assessed using the MOLLI sequence and may reflect the myelination. EVIDENCE LEVEL: 3 TECHNICAL EFFICACY: Stage 2.

Detection of subclinical keratoconus using a novel combined tomographic and biomechanical model based on an automated decision tree.

Early detection of keratoconus is a crucial factor in monitoring its progression and making the decision to perform refractive surgery. The aim of this study was to use the decision tree technique in the classification and prediction of subclinical keratoconus (SKC). A total of 194 eyes (including 105 normal eyes and 89 with SKC) were included in the double-center retrospective study. Data were separately used for training and validation databases. The baseline variables were derived from tomography and biomechanical imaging. The decision tree models were generated using Chi-square automatic interaction detection (CHAID) and classification and regression tree (CART) algorithms based on the training database. The discriminating rules of the CART model selected metrics of the Belin/Ambrósio deviation (BAD-D), stiffness parameter at first applanation (SPA1), back eccentricity (Becc), and maximum pachymetric progression index in that order; On the other hand, the CHAID model selected BAD-D, deformation amplitude ratio, SPA1, and Becc. Further, the CART model allowed for discrimination between normal and SKC eyes with 92.2% accuracy, which was higher than that of the CHAID model (88.3%), BAD-D (82.0%), Corvis biomechanical index (CBI, 77.3%), and tomographic and biomechanical index (TBI, 78.1%). The discriminating performance of the CART model was validated with 92.4% accuracy, while the CHAID model was validated with 86.4% accuracy in the validation database. Thus, the CART model using tomography and biomechanical imaging was an excellent model for SKC screening and provided easy-to-understand discriminating rules.

Does the institutional environment influence corporate social responsibility? Consideration of green investment of enterprises-evidence from China.

Green investment, as a socially responsible investment, conforms to the concept of ecological civilization. It is considerable to promote enterprises to make green investment. This article is based on 211 questionnaires for employees of various enterprises in China, using STATA.14 for descriptive statistical analysis, logistical regression analysis, and trend analysis. It aims to explore the impact of government-led institutional environment on enterprises from five aspects. This study examines that the institutional environment has a positive effect on enterprise' green investment from the legal and cultural aspects, but it has no significant impact from the political, economic, and financial aspects. Finally, this paper provides policy advice that can promote the construction of institutional environment to encourage enterprises to make green investment.

Construction of an index system of core competence assessment for infectious disease specialist nurse in China: a Delphi study.

AIM AND OBJECTIVE: This study was to establish an index system for the evaluation of Chinese infectious disease specialist nurses' core competence. BACKGROUND: The index system for the evaluation of infectious disease specialist nurses' core competence has not been established. DESIGN: A two-round Delphi survey was conducted to seek opinions from experts about the index system for the evaluation of infectious disease specialist nurses' core competence. METHODS: The study adopted several research methods, including literature retrieval, theoretical analysis and qualitative research. Based on the above method, the draft of core competence evaluation index system of infectious disease specialist nurses was constructed. A Delphi survey was used for the study of 30 infectious disease experts from 8 provinces and cities around China. A modified recommendation for the Conducting and Reporting of Delphi studies (CREDES) was also used to guide this study. A STROBE checklist was used. RESULTS: The Core Competence Evaluation Index System of Infectious Disease Nurses is composed of 6 primary indicators, namely, Nursing Abilities for Infectious Diseases, Infection Prevention and Control Abilities, Responsiveness to Infectious Diseases, Professional Development Abilities, Communication and Management Abilities, and Professionalism and Humanistic Accomplishment, 16 secondary indicators and 47 tertiary indicators. The authority coefficient, judgment coefficient and familiarity degree of Delphi experts were 0.923, 0.933 and 0.913 respectively. CONCLUSIONS: The evaluation index system of core competence of diseases specialist nurses is scientific and reliable. It can be reference for future training and assessment of Chinese infectious disease specialist nurses. RELEVANCE TO CLINICAL PRACTICE: Infectious disease specialist nurses are the main force for infectious disease nursing. Their core competence is related to the quality of infectious disease nursing and treatment. The core competence of the nurses is important for identification of training strategies and can be regarded as reference for nurse assessment and promotion. The construction of the index system is based on the consensus of infectious disease experts, which is not only helpful to standardize the training strategies and selection standards of infectious disease specialist nurses in the future, but also meet the society's needs in clinical infectious disease nursing.

Effectiveness and Safety of Direct Oral Anticoagulants in an Asian Population with Atrial Fibrillation Undergoing Dialysis: A Population-Based Cohort Study and Meta-Analysis.

PURPOSE: Whether direct oral anticoagulants (DOACs) are more effective and safer than warfarin among Asian patients with non-valvular atrial fibrillation (NVAF) undergoing dialysis remains unclear. METHODS: We first compared the risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding associated with DOACs compared with warfarin, in NVAF Asians undergoing dialysis using the Taiwan National Health Insurance Research Database (NHIRD) (Aim 1). Next, we searched PubMed and Medline from January 1, 2010 until January 31, 2020, to perform a systematic review and meta-analysis of all observational real-world studies comparing DOACs with warfarin specifically focused on NVAF patients with stage 4 or 5 chronic kidney disease undergoing dialysis (Aim 2). Finally, we tested the hypothesis whether AF patients undergoing dialysis treated with OACs (warfarin and DOACs) would be associated with lower risk of adverse clinical outcomes as compared to those without OACs using the Taiwan NHIRD (Aim 3). RESULTS: From June 1, 2012, to December 31, 2017, a total of 3237 and 9263 NVAF patients comorbid with ESRD receiving oral anticoagulant (OACs) (490 on DOAC, 2747 on warfarin) or no OACs, respectively, were enrolled. Propensity score matching was used to balance covariates across the study groups. For the comparison of DOAC vs. warfarin (Aim 1), DOACs had comparable risks of IS/SE and major bleeding to warfarin in our present cohort. From the original 85 results retrieved, nine studies (including our study) with a total of 6490 and 22,494 patients treated with DOACs and warfarin were included in the meta-analysis, respectively. There were 5343 (82%) and 20,337 (90%) patients treated with DOACs and warfarin undergoing dialysis, respectively. The pooled meta-analysis also indicated no difference of the effectiveness (HR:0.90; [95%CI:0.74-1.10]; P = 0.32) and safety outcomes (HR:0.75; [95%CI:0.54-1.05]; P = 0.09) between DOACs and warfarin (Aim 2). For the comparison of OAC (+) vs. OAC (-) (Aim 3), OAC-treatment was associated with a higher risk of IS/SE (hazard ratio (HR):1.54; [95% confidential interval (CI):1.29-1.84];P < 0.0001) and comparable risk of major bleeding compared to those without OAC treatment. CONCLUSIONS: DOACs did not provide benefit over warfarin regarding effectiveness and safety in AF patients undergoing dialysis. The use of OAC was not associated with a lower risk of IS/SE in ESRD AF patients when compared to those without OAC use.

Assessment of Body Weight Changes in Patients with Inflammatory Bowel Diseases Initiating Biologic Therapy: A Prospective Cohort Study.

BACKGROUND: Prior studies have inconsistently suggested that biologic therapy may be associated with weight gain in inflammatory bowel disease patients (IBD). Our aim was to compare weight gain across different biologic therapy classes with distinct mechanisms of action. METHODS: This prospective cohort study recruited patients with moderate to severe IBD initiating outpatient biologic therapy with anti-TNF (infliximab, adalimumab), vedolizumab, or ustekinumab. Weight measurements were performed at weeks 0, 14, 30, and 54. Changes in weight between baseline and each of the follow-up visits were modeled as a continuous variable, and multivariate regression assessed the independent effect of therapeutic class on this outcome. RESULTS: Our study enrolled 269 patients (163 CD, 106 UC) initiating biologic therapy [99 anti-TNF (37%), 122 vedolizumab (45%), 48 ustekinumab (18%)]. From baseline, the weight significantly increased at week 14 with a mean of 0.36 kg (± 3.8 kg, p = 0.004) and continued to increase compared to baseline with 0.96 kg (± 3.9 kg, p < 0.001) and 1.29 kg (± 4.2 kg, p < 0.001) at week 30 and 54, respectively. On univariate and multivariable analysis, no significant differences between any of the biologic therapies for weight gain were seen at any time point (weight gain anti-TNF: 0.31 kg, 1.06 kg, 1.33 kg; VDZ: 0.30 kg, 0.83 kg, 1.10 kg; UST: 0.63 kg, 1.21 kg, 2.31 kg at wk 14, wk 30, and wk 54, respectively). None of the disease activity parameters showed any statistical association with weight gain. CONCLUSION: There was no difference in weight gain among the different biologic therapeutic classes.