impHFrEF trial: study protocol for an open-label, multicentre study of improvement the outcome of patients with heart failure in China using a mobile hEalth-supported platForm.

BACKGROUND: Patients with chronic heart failure (CHF) often have a long duration of illness, difficulty in attending follow-up visits, and poor adherence to treatment. As a result, they frequently cannot receive guideline-directed medical therapy (GDMT) at the desired or maximum tolerable drug dosage. This leads to high hospitalisation and mortality rates for HF patients. Therefore, effective management and monitoring of patients with HF to ensure they receive GDMT is crucial for improving the prognosis. DESIGN AND METHODS: This is a multicentre, open-label, randomised, parallel-group study involving patients with CHF across five centres. The study aims to assess the impact of an optimised GDMT model for HF patients, established on a mobile health (mHealth) platform, compared with a control group. Patients must have a left ventricular ejection fraction of less than 50% and be receiving medication titration therapy that has not yet reached the target dose, with a modest increase in N-terminal pro-B-type natriuretic peptide level. The primary composite outcome is worsening HF events (hospitalisation or emergency treatment with intravenous fluids) or cardiovascular death. ETHICS AND DISSEMINATION: On 22 December 2021, this study received ethical approval from the Ethics Review Board of the First Affiliated Hospital of Nanjing Medical University, with the ethics number 2021-SR-530. All study participants will be informed of the research purpose and their participation will be voluntary. Informed consent will be obtained by providing and signing an informed consent form. We will ensure compliance with relevant laws and regulations regarding privacy and data protection. The results of this study will be published in a peer-reviewed academic journal. We will ensure that the dissemination of study results is accurate, clear and timely. TRIAL REGISTRATION NUMBER: ChiCTR2200056527.

Fever clinic construction and management targeted to prevention and control of healthcare-associated respiratory viral infections in Jiangsu, China: A cross-sectional observational study.

To analyze the post-COVID-19 construction and management of fever clinics targeted to prevention and control of healthcare-associated respiratory viral infections in medical institutions at all levels in China, and to provide a basis for promoting their standardized construction, we conducted this survey on the construction of fever clinics in 429 medical institutions of Jiangsu Province from July to December 2020. Contents of the questionnaire included the general situation of medical institutions, the construction status and future construction plans of fever clinics. We find the construction rate of fever clinic in medical institutions of Jiangsu province was 75.3%. All construction indicators, quality management systems and processes fail to fully meet the requirements of documents and standards. Jiangsu province actively promotes the construction of fever clinic layout, but there is still a gap with the construction standard. As a result, it is necessary to further promote standardized construction of fever clinic, and necessary financial input should be increased to expand all constructions of fever clinic in primary medical institutions.

Antibiotic prophylaxis after 48 h postoperatively are not associated with decreased surgical site infections and other healthcare associated infections in pancreatic surgery patients: a retrospective cohort study.

BACKGROUND: It is controversial whether antibiotic should be used prophylactically 48 h after pancreatic surgery. Hence, the association of antibiotic prophylaxis (AP) after 48 h postoperatively with the incidence of surgical site infections (SSIs) and other healthcare-associated infections (HAIs) in patients receiving pancreatic surgery was evaluated. METHODS: A retrospective cohort analysis was performed on 1073 patients who underwent pancreatic surgery. These patients were categorized into the non-AP after 48 h postoperatively group (n = 963) and the AP after 48 h postoperatively group (n = 110) based on whether or not they obtained AP from 48 h to 30 days after surgery. Outcomes included SSIs and other HAIs. RESULTS: The incidence of SSIs in the non-AP after 48 h postoperatively group (98/963, 10.2%) was notably lower than that in the AP after 48 h postoperatively group (22/110, 20.0%) (P = 0.002). Other HAIs incidence was not significantly different between the non-AP after 48 h postoperatively group (77/963, 8.0%) and the AP after 48 h postoperatively group (11/110, 10.0%) (P = 0.468). Multiple regression analysis demonstrated that AP after 48 h postoperatively was a risk factor for SSIs (OR = 2.14, 95% CI 1.28-3.59) but not for other HAIs (OR = 1.24, 95% CI 0.63-2.42) after adjustment for age, gender, and diabetes. Subsequent to adjustment for all confounding factors, AP after 48 h postoperatively was not a influence factor for SSIs (OR = 2.13, 95% CI 0.76-5.99) and other HAIs (OR = 3.69, 95% CI 0.99-13.81). CONCLUSIONS: AP after 48 h postoperatively following pancreatic surgery was not associated with the lower morbidity rate of SSIs and other HAIs. Nonetheless, this study may facilitate further development of strategies towards standardization of the duration of AP management of pancreatic surgery.

Controlled Ring-Opening Polymerization of Macrocyclic Monomers Based on Ring-Opening/Ring-Closing Cascade Reaction.

The development of a controlled ring-opening polymerization (ROP) method for synthesizing backbone-functionalized and sequence-controlled polymers with well-defined architectures from macrocyclic monomers is highly desirable in polymer chemistry. Herein, we developed a novel general controlled ROP of macrocycles for producing backbone functional and sequence-controlled polyurethanes and polyamides with controlled molecular weights and narrow dispersities (D < 1.1). The key to this method is the introduction of a trimethyl lock unit, an efficient cyclization-based self-immolative spacer, into the macrocyclic monomer ring as a "ring-opening trigger." ROP is initiated by the attack of a primary amine nucleophile on the ring-activated carbonate/ester group, leading to the ring opening of the macrocyclic monomer. Subsequently, spontaneous 6-exo-trig cyclization of the trimethyl lock unit occurs, detaching this ring-opening trigger and regenerating the primary amine end group. The regenerated primary amine group can then be used to propagate the polymer chain by iterating the ring-opening-ring-closing cascade reaction. The versatile ROP method can be applied in the synthesis of water-soluble polyurethanes, backbone-degradable polyurethanes and poly(ester amide)s, and sequence-controlled poly(amino acid)s with well-defined macromolecular architectures.

Environmental Contamination of SARS-CoV-2 Delta VOC by COVID-19 Patients Staying in the Hospital for More Than Two Weeks.

Background: Patients infected with SARS-CoV-2 Delta VOC have a longer course of disease. We detected the air, surfaces, and patient's personal items in the wards of the second hospital of Nanjing during the outbreak of the COVID-19 Delta Variant to identify the environmental contamination, which provides a theoretical basis for the prevention and control of COVID-19 variation beads in the future. Methods: In the cross-sectional study, we collected and analyzed clinical features, demographic and epidemiological data, laboratory and swab test results, and surface and air samples of 144 COVID-19 cases. Results: The time from symptom onset to surface sampling was 25 days (IQR, 21 to 33 days). Positive throat swabs were detected in 52(36.1%) patients, of which only 8(5.6%) patients had N or ORF1a/b genes Ct value <35 on the surface sampling day. Among the 692 environmental surface and air specimens collected from 144 COVID-19 cases, 3 specimens (3/692, 0.4%) related to 5 cases (3.5%, 5/144) were detected positive on RT-PCR. Overall, bedside tables (2/144, 1.4%) were most likely to be contaminated, followed by toilet seats (1/81, 1.2%). Conclusion: The environmental contamination by SARS-CoV-2 Delta VOC-infected cases with disease duration of more than two weeks is limited.

Study on the Detection and Infection Distribution of Multidrug-Resistant Organisms in Different Specimens.

Objective: To analyze the infection and distribution of multidrug-resistant organisms (MDRO) in different clinical specimens, thereby providing a reference for clinical diagnosis and treatment and prevention and control. Patient and Methods: 2314 strains of MDRO isolated from clinical specimens in the First Affiliated Hospital of Nanjing Medical University from January to December 2020. MDRO were collected by Information System. The detection rate of MDRO, infection rate, the proportion of infection, and detection rate of MDRO infection in different specimens were analyzed. Results: The top three specimens in the detection rate of MDRO were BALF (60.71%), sputum (33.68%), and blood (28.79%). The top three specimens in the proportion of MDRO infection were blood (97.74), other sterile body fluids (90.35%), and BALF (90.20%). The top three specimens in the MDRO infection rate were BALF (9.75%), sputum (3.07%), and secretions (2.90%). The top three specimens in the detection rate of MDRO infection were sputum (0.63‰), other sterile body fluids (0.13‰), and secretions (0.11‰). Conclusion: The detection and infection distribution of MDRO vary greatly in different specimens. The submission of sterile body fluids for examination should be strengthened and the standard of sample collection should be highlighted.

Case fatality rate of the adult in-patients with COVID-19 and digestive system tumors: A systematic review and meta-analysis.

BACKGROUND: During the coronavirus disease 2019 (COVID-19) pandemic, endoscopic screening for gastrointestinal tumors was suspended or delayed in most countries. Thus, our study aimed to quantify the impact of COVID-19 on the clinical outcomes of patients with digestive system tumors through a systematic review and meta-analysis. METHODS: We systematically searched the PubMed, Web of Science, Cochrane Library, and Embase databases as of March 7, 2021 to identify the case fatality rate (CFR) of COVID-19 patients diagnosed with digestive system tumors. A random-effects model was used for meta-analysis, I2 was used to assess heterogeneity, and funnel plot was used to assess publication bias. RESULTS: A total of 13 studies were included, involving 2943 tumor patients with COVID-19, of which 871 were digestive system tumors, and the CFR was 24% (95% CI, 18%-30%; I2 = 55.7%). The mortality rate of colorectal cancer was 21% (95% CI, 14%-27%; I2 = 0.0%), gastric cancer was 25% (95% CI, 6%-45%; I2 = 0.0%), and hepatobiliary cancer was 29%. In general, there was no significant difference in the CFR of digestive system tumors. CONCLUSION: The combined CFR of digestive system tumors and COVID-19 patients was 24%, which is much higher than that of the general population. Under the premise of fully complying with the international guidelines to limit the spread of COVID-19, we call for the resumption of endoscopic screening programs and selective surgery as soon as possible. REGISTRATION INFORMATION: PROSPERO registration no. CRD42021248194.

Effect of Direct Bilirubin Level on Clinical Outcome and Prognoses in Severely/Critically Ill Patients With COVID-19.

Objectives: We aimed to investigate how changes in direct bilirubin (DBiL) levels in severely/critically ill the coronavirus disease (COVID-19) patients during their first week of hospital admission affect their subsequent prognoses and mortality. Methods: We retrospectively enrolled 337 severely/critically ill COVID-19 patients with two consecutive blood tests at hospital admission and about 7 days after. Based on the trend of the two consecutive tests, we categorized patients into the normal direct bilirubin (DBiL) group (224), declined DBiL group (44) and elevated DBiL group (79). Results: The elevated DBiL group had a significantly larger proportion of critically ill patients (χ2-test, p < 0.001), a higher risk of ICU admission, respiratory failure, and shock at hospital admission (χ2-test, all p < 0.001). During hospitalization, the elevated DBiL group had significantly higher risks of shock, acute respiratory distress syndrome (ARDS), and respiratory failure (χ2-test, all p < 0.001). The same findings were observed for heart damage (χ2-test, p = 0.002) and acute renal injury (χ2-test, p = 0.009). Cox regression analysis showed the risk of mortality in the elevated DBiL group was 2.27 (95% CI: 1.50-3.43, p < 0.001) times higher than that in the normal DBiL group after adjusted age, initial symptom, and laboratory markers. The Receiver Operating Characteristic curve (ROC) analysis demonstrated that the second test of DBiL was consistently a better indicator of the occurrence of complications (except shock) and mortality than the first test in severely/critically ill COVID-19 patients. The area under the ROC curve (AUC) combined with two consecutive DBiL levels for respiratory failure and death was the largest. Conclusion: Elevated DBiL levels are an independent indicator for complication and mortality in COVID-19 patients. Compared with the DBiL levels at admission, DBiL levels on days 7 days of hospitalization are more advantageous in predicting the prognoses of COVID-19 in severely/critically ill patients.

Incidence and outcomes of patients with COVID-19 associated pulmonary aspergillosis (CAPA) in intensive care units: a systematic review and meta-analysis of 31 cohort studies.

BACKGROUND: We aimed to identify studies systematically that describe the incidence and outcome of COVID-19-related pulmonary aspergillosis (CAPA). METHODS: We searched ScienceDirect, PubMed, CNKI, and MEDLINE (OVID) from December 31, 2019 to November 20, 2021 for all eligible studies. Random-model was used to reported the incidence, all-cause case fatality rate (CFR) and 95% confidence intervals (CIs). The meta-analysis was registered with PROSPERO (CRD42021242179). RESULTS: In all, thirty-one cohort studies were included in this study. A total of 3,441 patients with severe COVID-19 admitted to an intensive care unit (ICU) were investigated and 442 cases of CAPA were reported (30 studies). The pooled incidence rate of CAPA was 0.14 (95% CI: 0.11-0.17, I2=0.0%). Twenty-eight studies reported 287 deceased patients and 269 surviving patients. The pooled CFR of CAPA was 0.52 (95% CI: 0.47-0.56, I2=3.9%). Interestingly, patients with COVID19 would develop CAPA at 7.28 days after mechanical ventilation (range, 5.48-9.08 days). No significant publication bias was detected in this meta-analysis. DISCUSSION: Patients with COVID-19 admitted to an ICU might develop CAPA and have high all-cause CFR. We recommend conducting prospective screening for CAPA among patients with severe COVID-19, especially for those who receive mechanical ventilation over 7 days.

Pancreatoduodenectomy within 2 weeks after endoscopic retrograde cholangio-pancreatography increases the risk of organ/space surgical site infections: a 5-year retrospective cohort study in a high-volume centre.

BACKGROUND: Organ/space surgical site infections (OSSI) after pancreaticoduodenectomy (PD) are not rare events. The role of diagnosis and treatment for pancreatic and biliary diseases with an endoscopic retrograde cholangio-pancreatography (ERCP) procedure is currently controversial. However, the ERCP procedure might play a role in surgical outcomes after PD. METHODS: We conducted a retrospective cohort study for patients who underwent PD in the First Affiliated Hospital with the Nanjing Medical University from 1st September 2012 to 31st January 2018. The relationship between ERCP exposure and OSSI after PD was analyzed by univariate and forward stepwise multivariate logistic regression model. RESULTS: Of the 1,365 patients who underwent PD, 136 developed OSSI (10.0%). We found that ERCP exposure before PD (EEBPD) was significantly associated with an increased incidence rate of post-operative pancreas fistula (POPF) [24.2% (23/95) vs. 14.9% (189/1,270), risk ratio (RR) =1.63, 95% confidence interval (CI), 1.11-2.38, P=0.015]. Hypertension, a higher level of preoperative low-density lipoprotein (LDL) and creatinine (Cr) were associated with elevated risks of post-operative OSSI [adjusted odds ratio (Adj-OR) (95% CI) were 1.59 (1.09-2.32), 1.70 (1.16-2.51), 1.99 (1.36-2.92)], whereas a preoperatively higher level of aspartate aminotransferase (AST) would decrease the risk [Adj-OR (95% CI), 0.62 (0.42-0.91)]. Remarkably, EEBPD would significantly increase and more than double the OSSI risk [Adj-OR (95% CI), 2.56 (1.46-4.47)] especially if it was within 14 days before surgery (Spearman =-0.698, P<0.001). CONCLUSIONS: ERCP, as an independent risk factor, significantly increased the risk of post-operative OSSI after PD if it is performed within 14 days prior to surgery. Our findings would assist clinical decision-making, and improve OSSI control and prevention.

Comparative analysis of laboratory indexes of severe and non-severe patients infected with COVID-19.

BACKGROUND: The pandemic coronavirus disease 2019 (COVID-19) has threaten the global health. The characteristics of laboratory findings of coronavirus are of great significance for clinical diagnosis and treatment. We found indicators that may most effectively predict a non-severe COVID-19 patient develop into a severe patient. METHODS: We conducted a meta-analysis to compare the laboratory findings of severe patients with non-severe patients with COVID-19 from searched articles. RESULTS: Through the analysis of laboratory examination information of patients with COVID-19 from 35 articles (5912 patients), we demonstrated that severe cases possessed higher levels of leukocyte (1.20-fold), neutrophil (1.33-fold), CRP (3.04-fold), PCT (2.00-fold), ESR (1.44-fold), AST (1.40-fold), ALT (1.34-fold), LDH (1.54-fold), CK (1.44-fold), CK-MB (1.39-fold), total bilirubin (1.14-fold), urea (1.28-fold), creatine (1.09-fold), PT (1.03-fold) and D-dimer (2.74-fold), as well as lower levels of lymphocytes (1.44-fold), eosinophil (2.00-fold), monocyte (1.08-fold), Hemoglobin (1.53-fold), PLT (1.15-fold), albumin (1.15-fold), and APTT (1.02-fold). Lymphocyte subsets and series of inflammatory cytokines were also different in severe cases with the non-severe ones, including lower levels of CD4 T cells (2.10-fold) and CD8 T cells (2.00-fold), higher levels of IL-1ß (1.02-fold), IL-6 (1.93-fold) and IL-10 (1.55-fold). CONCLUSIONS: Some certain laboratory inspections could predict the progress of the COVID-19 changes, especially lymphocytes, CRP, PCT, ALT, AST, LDH, D-dimer, CD4 T cells and IL6, which provide valuable signals for preventing the deterioration of the disease.

Evaluation of manual and electronic healthcare-associated infections surveillance: a multi-center study with 21 tertiary general hospitals in China.

BACKGROUND: Healthcare-associated infections (HAIs) are still a major health threats worldwide. Traditional surveillance methods involving manual surveillance by infection control practitioners (ICPs) for data collection processes are laborious, inefficient, and generate data of variable quality. In this study, we sought to evaluate the impact of surveillance and interaction platform system (SIPS) for HAIs surveillance compared to manual survey in tertiary general hospitals. METHODS: A large multi-center study including 21 tertiary general hospitals and 63 wards were performed to evaluate the impact of electronic SIPS for HAIs. RESULTS: We collected 4,098 consecutive patients and found that the hospitals installed with SIPS significantly increased work efficiency of ICPs achieving satisfactory diagnostic performance of HAIs with 0.73 for sensitivity, 0.81 for specificity and 0.81 area under the curve (AUC). However, there were significant heterogeneity own to regions, time of SIPS installation, departments and sample size. CONCLUSIONS: SIPS significantly improved ICPs efficiency and HAIs monitoring effectiveness, but there were shortcomings such as untimely maintenance and high cost.

Interpretation and clinical practice of regulation for prevention and control of healthcare associated infection in outpatient and emergency department in healthcare facilities.

Healthcare associated infection (HAI) control and prevention is the important component of medical safety. Healthcare workers (HCWs) are the core forces for implementing good HAI control and prevention. Several cases of outbreaks occurred in outpatient and emergency department (OED) strengthened the importance of infection control and prevention. Recently, the "Regulation for prevention and control of HAI in outpatient and emergency department in healthcare facilities" was released by National health Commission of the People's Republic of China on May 10, 2018 and was going to implement on Nov 1, 2018. This regulation stipulates basic infection prevention requirements for safe care in OED of healthcare facilities. In this article, we would provide the interpretation and clinical practice of regulation for prevention and control of HAI in outpatient and emergency department in healthcare facilities and give a summary introduction.

Prevalence and burden of hepatitis D virus infection in the global population: a systematic review and meta-analysis.

OBJECTIVE: Hepatitis D virus (HDV) is a defective virus that completes its life cycle only with hepatitis B virus (HBV). The HBV with HDV super-infection has been considered as one of the most severe forms of the chronic viral hepatitis. However, there is a scarcity of data on the global burden of HDV infection. DESIGN: We searched PubMed, Embase, Cochrane Library and China Knowledge Resource Integrated databases from 1 January 1977 to 31 December 2016. We included studies with a minimum sample size of 50 patients. Our study analysed data from a total of 40 million individuals to estimate the prevalence of HDV by using Der-Simonian Laird random-effects model. The data were further categorised according to risk factors. RESULTS: From a total of 2717 initially identified studies, only 182 articles from 61 countries and regions met the final inclusion criteria. The overall prevalence of HDV was 0.98% (95% CI 0.61 to 1.42). In HBsAg-positive population, HDV pooled prevalence was 14.57% (95% CI 12.93 to 16.27): Seroprevalence was 10.58% (95% CI 9.14 to 12.11) in mixed population without risk factors of intravenous drug use (IVDU) and high-risk sexual behaviour (HRSB). It was 37.57% (95% CI 29.30 to 46.20) in the IVDU population and 17.01% (95% CI 10.69 to 24.34) in HRSB population. CONCLUSION: We found that approximately 10.58% HBsAg carriers (without IVDU and HRSB) were coinfected with HDV, which is twofold of what has been estimated before. We also noted a substantially higher HDV prevalence in the IVDU and HRSB population. Our study highlights the need for increased focus on the routine HDV screening and rigorous implementation of HBV vaccine programme.

Novel risk factors for the healthcare associated infections (HAIs) in patients with Stanford type A aortic dissection (TAAD).

BACKGROUND: Risk factors for healthcare associated infections (HAIs) following surgical repair of acute type A aortic dissection (TAAD) has not been well defined. METHODS: This was a retrospective study of patients treated between Jan 2013 and May 2016 at the large tertiary teaching hospital in Jiangsu, China. Logistic regression analysis was performed to investigate the association patients with acute TAAD who underwent ascending aortic and arch replacement under deep hypothermic circulatory arrest (DHCA) and healthcare associated infections during hospitalization. RESULTS: Of the final 210 patients with aortic dissection (AD) admitted to our hospital, 100 patients had TAAD (100/210, 47.62%), which were then allocated to the HAIs group (n=36) and Non-HAIs group (n=64). We found that DCHA >29 min [odds ratio (OR) =2.60, 95% confidential interval (CI), 1.01-6.80, P=0.048], preoperative PLT <171×109/L (OR =3.62; 95% CI, 1.33-9.79; P=0.011) and D-dimer >4.25 mg/L (OR =2.83; 95% CI, 1.07-7.47; P=0.035) were independently associated with the occurrence of HAIs for the patients with TAAD following surgical repair. Hosmer-Lemeshow statistic of the model suggested perfect model discrimination from a perfect fit (χ2=4.77, P=0.6883). Logistic model was verified when the area under receiver operating characteristic (ROC) curve was equal to 0.7665. CONCLUSIONS: TAAD patients with longer DHCA time, lower preoperative PLT, higher serum D-dimer would significantly increase the risks after surgical repair of arch replacement.

Prognostic factors for operable biliary tract cancer: serum levels of lactate dehydrogenase, a strong association with survival.

BACKGROUND: Biliary tract cancers (BTCs) are uncommon but fatal, with a low 5-year survival rate after surgical resection. This study was designed to investigate the prognostic factors for operable BTC. METHODS: Baseline demographics at diagnosis were retrospectively evaluated in 341 BTC patients undergoing radical surgery at The First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2015. The association between prognostic factors and overall survival (OS) was determined by multivariate analysis using the Cox proportional hazards regression model. RESULTS: Our study showed that 341 patients were included in the analysis, of which 166 (48.7%) were males and 175 (51.3%) were females. Older age, depth of tumor invasion, positive surgical margin, lower hemoglobin, and higher lactic dehydrogenase (LDH) were associated with significantly worse OS using multivariate analysis. In the entire cohort, the estimate of median OS in patients with LDH <271 U/L was 36.291 months (95% CI; 30.989-41.594 months), and 30.736 months (95% CI; 19.154-42.318 months) in patients with LDH ≥271 U/L (adjusted HR-1.505, 95% CI; 1.009-2.245, P = 0.045). Moreover, it was investigated whether serum LDH retained its significance as a prognostic marker in BTC subgroups separately. The results showed that LDH was prognostic in patients with distal bile duct (DBD) carcinoma undergoing radical surgery (HR-2.452, 95% CI; 1.167-5.152, P = 0.018). However, there were no statistical differences between LDH and OS in multivariate analysis in the other three individual subgroups except for DBD carcinoma. This may be due to the limited number of patients in the study, indicating that a greater number of patients may be required for statistical significance. CONCLUSION: Older age, depth of tumor invasion, positive surgical margin status, lower hemoglobin levels, and elevated serum LDH level are associated with poor survival in operable BTC patients. Serum LDH level is a cost-effective prognostic biomarker in patients with operable BTC and especially DBD carcinoma.