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High-risk factors for adverse pregnancy outcomes in systemic lupus erythaematosus: a retrospective study of a Chinese population

Por: Jiang · M. · Chang · Y. · Wang · Y. · Fu · Q. · Lin · S. · Wu · J. · Di · W.
Objective

To clarify high-risk factors for adverse pregnancy outcomes (APOs) in systemic lupus erythaematosus (SLE).

Design

A retrospective chart review study.

Setting

Data were collected in a tertiary medical centre, Shanghai, China, from November 2010 to December 2018.

Participants

A total of 513 pregnancies with SLE were retrospectively analysed. Twenty-seven patients who underwent artificial abortions due to personal reasons were excluded.

Primary outcome measures

APOs were primary outcomes, including foetal loss, premature birth, small for gestational age (SGA), asphyxia neonatorum, composite foetal APOs and hypertensive disorders of pregnancy (HDP). Multivariable logistic regression and Spearman correlation analysis were performed to determine the risk factors for APOs in SLE.

Results

Risk factors for foetal loss included prepregnancy hypertension, hypocomplementaemia-C3, anticardiolipin antibodies-IgM positivity and disease flares during pregnancy. Risk factors for premature birth included disease flares, use of immunosuppressive agents and HDP. Moreover, twin pregnancy, disease flares and HDP were risk factors for SGA, and prepregnancy hypertension was an independent risk factor for asphyxia neonatorum. Independent risk factors for composite foetal APOs included twin pregnancy, prepregnancy hypertension, disease flares during pregnancy, HDP, hypocomplementaemia-C3 and the use of immunosuppressive agents. Risk factors for SLE complicated with HDP included prepregnancy hypertension, renal disorders and thrombocytopaenia. Conversely, the use of aspirin was a protective factor against foetal loss and premature birth. The ds-DNA value had a low diagnostic value for APOs, whereas the extent of complement reduction may predict the incidence of composite foetal APOs and foetal loss. Proteinuria occurring in the first 20 gestational weeks may lead to APOs.

Conclusion

Established risk factors for each APO were identified in this study. Indicators with more predictive significance have been screened out from conventional indicators, which may help clinicians predict the pregnancy outcome of patients with SLE more accurately and minimise the incidence of APOs.

Characteristics of Chinese patients with genetic CJD who have E196A or E196K mutation in PRNP: comparative analysis of patients identified in the Chinese National CJD Surveillance System

Por: Shi · Q. · Xiao · K. · Chen · C. · Zhou · W. · Gao · L.-P. · Wu · Y.-Z. · Wang · Y. · Hu · C. · Gao · C. · Dong · X.-P.
Objective

Two different mutations at codon 196, namely E196A and E196K, have been reported to be related to genetic Creutzfeldt-Jakob disease (CJD). We aimed to comparatively analyse the features of Chinese patients with these two mutations from the CJD surveillance system in China.

Design and setting

Comparative analysis of patients identified via the Chinese National CJD Surveillance System during the period 2006–2020.

Participants

16 Chinese patients with genetic CJD with E196A mutation and 5 with E196K mutation.

Methods

Neurological examination, EEG and MRI, western blot, gene sequence, and RT-QuIC.

Results

The age of onset of E196K genetic CJD cases (median of 61 years) was older than the E196A cases (median of 67 years). Generally, these two subtypes of genetic CJD were more like sporadic Creutzfeldt-Jakob disease (sCJD) clinically. The E196A cases showed more major symptoms, while those of E196K cases were restricted to dementia and mental problems. During progression, more sCJD-associated symptoms and signs gradually appeared, but none of the E196K cases showed cerebellum and visual disturbances. Typical periodic sharp wave complexes on MRI were recorded in 25% of E196A cases but not in E196K cases. sCJD-associated abnormalities on MRI, positive cerebrospinal fluid (CSF) 14-3-3 and increased CSF total tau were observed frequently, ranging from two out of three cases to four out of five cases, without a difference. Positive CSF RT-QuIC was detected in 37.5% (6 of 16) of E196A cases and 60% (3 of 5) of E196K cases. The duration of survival of E196K cases (median of 4.5 months) was shorter than the E196A cases (median of 6.5 months). Moreover, female cases and cases with young age of onset (

Conclusions

This is the largest comprehensive report of genetic CJD with mutations at codon 196 to date, describing the similarity and diversity in clinical and laboratory tests between patients with E196A and with E196K mutations.

A time‐saving method of creating AVF buttonholes: indwelling trocar technique

Abstract

Aims and Objectives

This study aims to explore the convenience and practicality of the method of establishing buttonholes with indwelling trocars.

Background

Compared with rope-ladder technique, buttonhole cannulation has better applicability for haemodialysis patients, and the method of buttonhole establishment is particularly important.

Design

Prospective, observational and cohort study.

Methods

We conducted a 12-month observational study on 30 patients who used sharp needles to establish buttonholes and 33 patients who used indwelling trocars to establish buttonholes, and compared the differences between the two groups in the buttonhole formation time, patient-reported cannulation pain, buttonhole success rate, AVF-related infection and patency of AVF. The study adhered to STROBE guidelines.

Results

The buttonhole formation time of the indwelling trocar group is less than that of the sharp needle group (5.48 ± 0.51 vs. 23.23 ± 3.07, p < .01). When the buttonhole was used for the first time, the cannulation pain of the indwelling trocar group was less than that of the sharp needle group (4.94 ± 1.50 vs. 6.03 ± 1.13, p = .002), but there was no significant difference in this result after 1 month (sharp needle group with 4.50 ± 0.94 vs. indwelling trocar group with 4.12 ± 1.19, p = .169). Compared with all the buttonholes in the indwelling trocar group were established successfully, there were 5 unsuccessful buttonholes in the sharp needle group (p = .02). Three cases of unsuccessful buttonhole patients in the sharp needle group developed AVF-related infection, this result did not appear in the indwelling trocar group (p = .102). The difference in arterial pressure and venous pressure between the two groups was not significant (p = .061, p = .222).

Conclusions

Our new method can help buttonhole patients get less track formation time, less cannulation pain, and less fistula infection, thereby bringing them a more comfortable dialysis experience.

Relevance to clinical practice

The new method used in this study not only meets the needs of patients to protect AVF, but also provides convenience for clinical work. In addition, this study analyzed the causes of the AVF infection in buttonhole patients, and provided directions for future research.

Neutrophil-to-lymphocyte ratio as a predictor of mortality in intensive care unit patients: a retrospective analysis of the Medical Information Mart for Intensive Care III Database

Por: Wu · X. · Luo · Q. · Su · Z. · Li · Y. · Wang · H. · Liu · Q. · Yuan · S. · Yan · F.
Objectives

Identifying high-risk patients in the intensive care unit (ICU) is important given the high mortality rate. However, existing scoring systems lack easily accessible, low-cost and effective inflammatory markers. We aimed to identify inflammatory markers in routine blood tests to predict mortality in ICU patients and evaluate their predictive power.

Design

Retrospective case–control study.

Setting

Single secondary care centre.

Participants

We analysed data from the Medical Information Mart for Intensive Care III database. A total of 21 822 ICU patients were enrolled and divided into survival and death groups based on in-hospital mortality.

Primary and secondary outcome measures

The predictive values of potential inflammatory markers were evaluated and compared using receiver operating characteristic curve analysis. After identifying the neutrophil-to-lymphocyte ratio (NLR) as having the best predictive ability, patients were redivided into low (≤1), medium (1–6) and high (>6) NLR groups. Univariate and multivariate logistic regression analyses were performed to evaluate the association between the NLR and mortality. The area under the curve (AUC), net reclassification improvement (NRI) and integrated discrimination improvement (IDI) were used to assess whether incorporating the NLR could improve the predictive power of existing scoring systems.

Results

The NLR had the best predictive ability (AUC: 0.609; p

Conclusions

The NLR predicted mortality in ICU patients well. Both low and high NLRs were associated with elevated mortality rates, including the NLR may improve the predictive power of the Simplified Acute Physiology Score II.

The effectiveness of a medical clowning program on improving emotional status among hospitalized children undergoing cancer treatment: A quasi‐experimental study

Abstract

Purpose

To examine the effectiveness of one-time medical clowning on improving short-term positive emotions among hospitalized children undergoing cancer treatment, and to analyze whether age moderates this effect.

Design

In this quasi-experimental research study, we recruited a pooled sample of 96 children who were undergoing cancer treatment in pediatric oncology/hematology wards at three university-affiliated medical centers in Taiwan from June 2018 through April 2020.

Methods

Children’s demographic characteristics, symptom distress, quality of life, and pretest emotional status were collected at T1. At T2, we collected only posttest emotional status. We adapted generalized estimating equation models to evaluate the effectiveness of medical clowning on enhancing positive emotions.

Findings

Changes in the probabilities of positive emotion were significantly different across groups (51.84% for the experimental group, 15.76% for the control group; Δ = 36.08, p = 0.001), and the change was more than two times larger for the experimental group (effect ratio = 3.28, p < 0.05) than for the control group. When evaluating the moderating effect of age on the intervention, none of the coefficients reached the significant (p < 0.05) levels, suggesting that age may not moderate the intervention effect.

Conclusion

This study demonstrates the core value of medical clowning in child-friendly health care. Our findings clearly support the benefit of the one-time medical clowning program on enhancing short-term emotional well-being across age groups of children. Medical clowning programs should be strongly encouraged and supported in pediatric oncology wards.

Clinical relevance

Medical clowning programs should be widely and continuously implemented in pediatric oncology wards as a routine clinical practice for enhancing emotional well-being among children receiving cancer treatment. Nurses need to be aware of medical clowning’s equal effectiveness across age groups, not only or better for younger children.

Oxymatrine promotes hypertrophic scar repair through reduced human scar fibroblast viability, collagen and induced apoptosis via autophagy inhibition

Abstract

Scars are common complications of burns and trauma, resulting in mental trauma, physical pain, and a heavy financial burden for patients. Specific and effective anti-scarring drugs are lacking in clinical practice. Phytochemicals are easily accessible, low in toxicity, and have various biological and pharmacological properties. Oxymatrine is a phytochemical that regulates autophagy networks. Autophagy is closely related to the maintenance, activity, differentiation, and life-death of skin fibroblasts during wound repair, which results in pathological scars. We hypothesised that oxymatrine may promote hypertrophic scar repair by inhibiting fibroblast autophagy. In vitro studies showed that inhibition of autophagy by oxymatrine decreased viability and collagen metabolism, and increased apoptosis of human scar fibroblasts (HSFs). In vivo studies showed that inhibition of autophagy by oxymatrine promoted scar repair, resulting in a significantly improved final outcome of the hypertrophic scars, a smaller scar area, decreased epidermal and dermal thickness, and a significant downregulation of CK10, P63, collagen I, α-SMA, and TGF-β1. In summary, oxymatrine promoted hypertrophic scar repair by decreasing HSF viability and collagen, and inducing apoptosis via autophagy inhibition. This study provides a new perspective on the mechanism of hypertrophic burn scar formation, as well as key scientific data for the application of the phytochemical oxymatrine as a new method for the prevention and treatment of hypertrophic scars.

Prospective characterisation of SARS-CoV-2 infections among children presenting to tertiary paediatric hospitals across Australia in 2020: a national cohort study

Por: Wurzel · D. · McMinn · A. · Hoq · M. · Blyth · C. C. · Burgner · D. · Tosif · S. · Buttery · J. · Carr · J. · Clark · J. E. · Cheng · A. C. · Dinsmore · N. · Francis · J. R. · Kynaston · A. · Lucas · R. · Marshall · H. · McMullan · B. · Singh-Grewal · D. · Wood · N. · Macartney · K. · Britto
Objective

To present Australia-wide data on paediatric COVID-19 and multisystem inflammatory syndromes to inform health service provision and vaccination prioritisation.

Design

Prospective, multicentre cohort study.

Setting

Eight tertiary paediatric hospitals across six Australian states and territories in an established research surveillance network—Paediatric Active Enhanced Disease (PAEDS).

Participants

All children aged

Intervention

Laboratory-confirmed SARS-CoV-2 infection.

Main outcome

Incidence of severe disease among children with COVID-19, PIMS-TS and KD-TS. We also compared KD epidemiology before and during the COVID-19 pandemic.

Results

Among 386 children with SARS-CoV-2 infection, 381 (98.7%) had COVID-19 (median 6.3 years (IQR 2.1–12.8),53.3% male) and 5 (1.3%) had multisystem inflammatory syndromes (PIMS-TS, n=4; KD-TS, n=1) (median 7.9 years (IQR 7.8–9.8)). Most children with COVID-19 (n=278; 73%) were Australian-born from jurisdictions with highest community transmission. Comorbidities were present in 72 (18.9%); cardiac and respiratory comorbidities were most common (n=32/72;44%). 37 (9.7%) children with COVID-19 were hospitalised, and two (0.5%) required intensive care. Postinfective inflammatory syndromes (PIMS-TS/KD-TS) were uncommon (n=5; 1.3%), all were hospitalised and three (3/5; 60%) required intensive care management. All children recovered and there were no deaths. KD incidence remained stable during the pandemic compared with prepandemic.

Conclusions

Most children with COVID-19 had mild disease. Severe disease was less frequent than reported in high prevalence settings. Preventative strategies, such as vaccination, including children and adolescents, could reduce both the acute and postinfective manifestations of the disease.

The association between obstructive sleep apnea and the risk of poor delivery events in women: A population‐based nested case–control study

Abstract

Purpose

To investigate the risk of poor delivery events (PDEs; premature delivery, abortion, and stillbirth) in female subjects with obstructive sleep apnea (OSA).

Methods

The study identified 8346 female subjects with PDEs as cases between January 1, 2000 and December 31, 2015 from the Longitudinal Health Insurance Database 2005 in Taiwan. A total of 33,384 controls were also identified based on frequency matching for age and year of index date. Diagnoses of OSA and PDEs were determined according to the International Classification of Diseases, 9th Revision. The risk of PDEs in female subjects with OSA was estimated with conditional logistic regression analyses.

Findings

The mean age of the 41,730 female subjects was 35.53 years. The overall incidence rate of PDEs was 506.22 per 100,000 person-years for subjects with OSA, which was significantly higher than that for the controls (501.95 per 100,000 person-years). The risk of PDEs was higher in subjects with OSA than in controls (adjusted odds ratio [AOR] = 1.19; 95% confidence interval [CI] [95% CI]: 1.08–1.43), including for premature delivery (AOR = 1.20; 95% CI: 1.16–1.50), and abortion (AOR = 1.19; 95% CI: 1.09–1.47). OSA showed no relation to stillbirth (AOR = 1.04; 95% CI: 0.99–1.31). The findings indicate that the longer a subject has been experiencing OSA, the higher the probability of PDEs.

Conclusions

The risk of PDEs associated with OSA was found in this study. In particular, the longer a subject has OSA, the higher the likelihood of PDEs, exhibiting a dose–response effect.

Clinical relevance

To effectively promote maternal health in clinical practice, health providers need to recognize OSA as a risk factor associated with negative pregnancy outcomes. Furthermore, OSA symptoms should be assessed and managed in all pregnant women to enable more comprehensive maternal care.

Predicting patient-level new-onset atrial fibrillation from population-based nationwide electronic health records: protocol of FIND-AF for developing a precision medicine prediction model using artificial intelligence

Por: Nadarajah · R. · Wu · J. · Frangi · A. F. · Hogg · D. · Cowan · C. · Gale · C.
Introduction

Atrial fibrillation (AF) is a major cardiovascular health problem: it is common, chronic and incurs substantial healthcare expenditure because of stroke. Oral anticoagulation reduces the risk of thromboembolic stroke in those at higher risk; but for a number of patients, stroke is the first manifestation of undetected AF. There is a rationale for the early diagnosis of AF, before the first complication occurs, but population-based screening is not recommended. Previous prediction models have been limited by their data sources and methodologies. An accurate model that uses existing routinely collected data is needed to inform clinicians of patient-level risk of AF, inform national screening policy and highlight predictors that may be amenable to primary prevention.

Methods and analysis

We will investigate the application of a range of deep learning techniques, including an adapted convolutional neural network, recurrent neural network and Transformer, on routinely collected primary care data to create a personalised model predicting the risk of new-onset AF over a range of time periods. The Clinical Practice Research Datalink (CPRD)-GOLD dataset will be used for derivation, and the CPRD-AURUM dataset will be used for external geographical validation. Both comprise a sizeable representative population and are linked at patient-level to secondary care databases. The performance of the deep learning models will be compared against classic machine learning and traditional statistical predictive modelling methods. We will only use risk factors accessible in primary care and endow the model with the ability to update risk prediction as it is presented with new data, to make the model more useful in clinical practice.

Ethics and dissemination

Permissions for CPRD-GOLD and CPRD-AURUM datasets were obtained from CPRD (ref no: 19_076). The CPRD ethical approval committee approved the study. The results will be submitted as a research paper for publication to a peer-reviewed journal and presented at peer-reviewed conferences.

Trial registration details

A systematic review to incorporate within the overall project was registered on PROSPERO (registration number CRD42021245093). The study was registered on ClinicalTrials.gov (NCT04657900).

Transcutaneous electrical acupoint stimulation combined with electroacupuncture for rapid recovery of patients after laparotomy for gastrointestinal surgery: a study protocol for a randomised controlled trial

Por: Li · H. · Wen · Q. · Lu · L. · Hu · H. · He · Y. · Zhou · Y. · Wu · X. · Li · N.
Introduction

Abdominal surgery is associated with common complications, including decreased or poor appetite, abdominal distension, abdominal pain caused by decreased or absent gastrointestinal motility, anal arrest with flatus and defecation, and nausea and vomiting resulting from the use of anaesthetics and opioid analgesics. These complications seriously affect postoperative recovery, prolong hospital stay and aggravate patient burden. This study aims to investigate for the first time the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with electroacupuncture (EA) therapy for rapid recovery after laparotomy for gastrointestinal surgery. There have been no clinical studies of this combination therapy.

Methods and analysis

This will be a prospective, single-centre, three-arm, randomised controlled trial. A total of 480 patients undergoing abdominal surgery will be stratified according to surgery type (ie, gastric or colorectal procedure) and randomised into three groups; namely, the EA, TEAS +EA and control groups. The control group will receive enhanced recovery after surgery (ERAS)-standardised perioperative management, including preoperative education, optimising the anaesthesia scheme, avoiding intraoperative hypothermia, restrictive fluid infusion and reducing surgical trauma. The EA group will receive EA stimulation at LI4, PC6, ST36, ST37 and ST39 based on the ERAS-standardised perioperative management. Moreover, the TEAS +EA group will receive ERAS-standardised perioperative management; EA stimulation at the LI4, PC6, ST36, ST37 and ST39; and TEAS stimulation at ST21 and SP15. The primary outcome will be the GI-2 (composite outcome of time to first defaecation and time to tolerance of a solid diet). Secondary outcomes will include the time of first passage of flatus, time to first defaecation, time to tolerance of a solid diet, time to first ambulation, hospital duration from operation to discharge, pain and nausea vomiting scores on the Visual Analogue Scale, medication use, incidence of postoperative complications and evaluation of treatment modality acceptability. All statistical analyses will be performed based on the intention-to-treat principle.

Ethics and dissemination

Ethics approval has been granted by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (approval number: 2021; number 52). The results are expected to be published in peer-reviewed journals.

Trial registration number

ChiCTR2100045646.

Effect of Pudilan Keyanning antibacterial mouthwash on dental plaque and gingival inflammation in patients during periodontal maintenance phase: study protocol for double-blind, randomised clinical trial

Por: Liu · J. · Huang · Y. · Lou · X. · Liu · B. · Liu · W. · An · N. · Wu · R. · Ouyang · X.
Introduction

Plaque control plays a critical role in the prevention and treatment of periodontitis. Antibacterial mouthwash is one of the most important tools for plaque control. Pudilan, including extracts of Scutellaria baicalensis root, Taraxacum mongolicum, Bunge corydalis herb and Isatis indigotica, was reported playing the role of anti-inflammatory and anti-bacterial. However, its effect on dental plaque and periodontal inflammation remains unknown. We aimed to assess the efficacy of Pudilan Keyanning antibacterial mouthwash which contains the active essence of Pudilan and 0.03%–0.06% cetylpyridinium chloride, as well as Pudilan active essence for plaque control and gingival anti-inflammation in patients during periodontal maintenance phase.

Methods and analysis

In this double-blind, randomised, placebo-controlled clinical trial, a total of 120 participants during periodontal maintenance phase will be enrolled. After supragingival scaling, they will be randomly assigned into three groups in a 1:1:1 ratio: the Pudilan Keyanning antibacterial mouthwash group, a chlorhexidine acetate mouthwash (0.12%) group or a placebo group with mouthwash containing the same components as the Pudilan Keyanning mouthwash except for Pudilan active ingredients. They will rinse with mouthwash, respectively, two times per day for 6 weeks. Clinical parameters (such as plaque index, bleeding index) and the level of volatile sulfide in the breath will be measured and analysed. The subgingival plaque will be collected and analysed microbiologically. Questionnaire feedback will be analysed.

Ethics and dissemination

The study protocol (V.4) was reviewed and approved by the Medical Ethical Committee of Peking University School and Hospital of Stomatology (Ethics Approval No. PKUSSIRB-201950153b). All participants signed a written consent form.

Trial registration number

ChiCTR2000041253.

Influence of dysregulated expression of circular RNA on the diagnosis and prognosis of breast cancer in Asia: a meta-analysis study

Por: Liu · F. · Wu · X. · Zhu · H. · Wang · F.
Objective

Recent studies have reported a correlation between non-coding RNAs such as circular RNAs (circRNAs) and clinical value of various cancers. However, the diagnostic and prognostic role of circRNA in breast cancer remains controversial.

Design

Systematic review and meta-analysis.

Methods

Diagnostic efficacy was estimated by sensitivity, specificity and area under the curve (AUC). Pooled HRs with 95% CIs estimated overall survival (OS), and ORs with 95% CIs investigated clinical features.

Results

By searching PubMed, Embase, Web of Science, CNKI and Cochrane Library, we obtained a total of 29 studies with 4405 patients. A shorter survival time was associated with high expression levels of tumour-promoter circRNAs (OS: HR=2.43, 95% CI 2.20 to 2.92, p

Conclusion

Dysregulated expression of circRNA was related to diagnosis and prognosis in breast cancer, which indicated it might be a novel biomarker and a target of therapy for breast cancer.

PROSPERO registration number

CRD42020207912.

Preterm birth among Pacific Islander women and related perinatal outcomes: a scoping review protocol

Por: Wu · B. · Arslanian · K. J. · Nyhan · K. · Taylor · S. · Shabanova · V. · Muasau-Howard · B. · Hawley · N. L.
Introduction

Infants born alive

Methods and analysis

We will follow the Joanna Briggs Institute Manual for Evidence Synthesis for scoping reviews and the Preferred Reporting Items for Scoping Reviews (PRISMA-ScR) to conduct this scoping review. The Covidence web application will be used for data management and consensus review. We will search on MEDLINE ALL (Ovid), EMBASE (Ovid), Web of Science Core Collection (as licensed at Yale), the Cochrane Library, CINAHL (EBSCOhost) and two non-indexed regional journals (Pacific Journal of Reproductive Health and Pacific Health Dialog). Title-abstract and full-text screening of eligible studies will be performed by two authors, and data will be extracted by the first author. Outcomes extracted will be presented using evidence mapping.

Ethics and dissemination

Findings will drive suggestions for new data collection needed to fill knowledge gaps and improve future study designs to decrease the burden of preterm birth among Pacific Islanders. There are no ethical concerns. This protocol will be disseminated in related peer-reviewed journals.

Prospective, multicentre, randomised controlled trial comparing the seroclearance of HBsAg between combination therapy of peg-interferon alpha and tenofovir with tenofovir monotherapy in nucleos(t)ide analogue-experienced patients with HBV-related liver f

Por: Zhu · S. · Wu · L. · Mei · Y. · Liu · Z. · Lin · L. · Yuan · J. · Li · J. · Li · X. · Peng · L.
Introduction

Combination antiviral therapy of nucleos(t)ide analogue (NA) and pegylated interferon alpha (peg-IFN alpha) decrease hepatitis B virus (HBV) surface antigen (HBsAg) levels to achieve functional cure and improve long-term prognosis in chronic hepatitis B patients. However, for hepatitis B-related liver fibrosis, studies on combination of these two medicines are limited. This study was designed to compare the efficacy between peg-IFN alpha combined with tenofovir (TDF) and TDF monotherapy for the clearance of HBsAg in NA-experienced patients with HBV-related liver fibrosis.

Methods and analysis

This study was designed to be a prospective, multicentre, open, randomised controlled study. A total of 272 patients with HBV-related liver fibrosis will be randomised into the combination therapy group or the monotherapy group at a 1:1 ratio. Participants in the combination group will receive subcutaneous injections of peg-IFN alpha 180 µg per week for 48 weeks combined with oral TDF 300 mg daily. Participants in the monotherapy group will receive 300 mg oral TDF daily alone. All participants will undergo long-term treatment with TDF and will be followed up at the outpatient department for 144 weeks after randomisation. Clinical symptoms, laboratory tests and examination indicators will be collected at each follow-up time point, and adverse events will be recorded. The primary endpoint is serological clearance rate of HBsAg at 48 weeks.

Ethics and dissemination

The ethics committee of the Third Affiliated Hospital at Sun Yat-sen University approved this study (Approval Number: (2020)02-183-01). The results of the study will be presented at relevant meetings and published in an appropriate journal after the completion of the trial and the analysis of the data.

Trial registration number

NCT04640129.

Effectiveness of horticultural therapy on physical functioning and psychological health outcomes for older adults: A systematic review and meta‐analysis

Abstract

Aims and Objectives

To systematically determine the effectiveness of horticultural therapy (HT) on the physical functioning and psychological health of older people.

Background

With advancing age and increased chronic diseases, older adults are vulnerable to physical deterioration and psychological problems. There is evidence that horticultural therapy (HT) has positive effect among older adults. However, less attention has been devoted to systematically evaluating the physical functioning and psychological health effects of HT in older adults.

Design

Systematic review and meta-analysis were conducted based on the checklist for PRISMA.

Methods

The searches were conducted in PubMed, EMBASE, CINAHL, PsycINFO, Cochrane, China Network Knowledge Infrastructure, Wan Fang, and China Science and Technology Journal Database, from their inception until June 2021. Randomised controlled trials published in either English or Chinese were reviewed. The Review Manager 5.4 software was used for meta-analyses. The quality of included studies was evaluated using the Cochrane risk of bias tool by two independent researchers.

Results

Ten studies involving 884 participants were included. Compared with the control group, HT can significantly improve upper body flexibility and aerobic endurance in older adults with cancer. Besides, HT was found to be more effective for promoting emotional functioning and well-being, subjective social functioning, and quality of life among the elderly. The attendance rate for HT was 66%–100%, and no negative events were found.

Conclusion

Horticultural therapy has potentially positive effects on the physical functioning and psychological health of older adults. However, more rigorous randomised controlled trials with larger populations are required to confirm the findings.

Relevance to clinical practice

As a safe and promising nonpharmacological intervention, healthcare professionals may consider the HT intervention when caring for older adults with cancer, dementia and frailty.

Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery

Por: Wu · H. · Yang · F. · Zhang · R. · Xue · H. · Yang · Y. · Liao · R. · Li · M. · Wu · X. · Chen · D. · Chen · G. · Gong · Y. · Hou · L.
Introduction

Patients with obstructive sleep apnoea (OSA) are more sensitive to postanaesthesia respiratory depression. Whether different anaesthetic regimens (intravenous-based or inhalational-based general anaesthesia) affect the postanaesthesia respiratory depression is controversial. Although desflurane has been reported that presents favourable rapid recovery profile in special patients including whom with OSA, the strong clinical evidence of the benefit on postanaesthesia respiratory depression is far from being revealed. This study aims to fill this knowledge gap by investigating the postanaesthesia respiratory depression in postanaesthesia care unit (PACU) in patients with OSA after major abdominal surgery, followed by desflurane-based anaesthesia compared with propofol-based anaesthesia.

Methods and analysis

Eight hundred and fifty-four patients with OSA scheduled for elective major abdominal surgery will be randomly 1:1 assigned to desflurane-based (n=427) or propofol-based anaesthesia (n=427) using a computer-generated randomisation scheme with permuted block size maintained by a centralised randomisation centre. Patients will be assessed before and a consecutive 3 days after their surgery according to the standardised tasks. Demographic data as well as surgical and anaesthesia information will be collected for the duration of the procedure. Incidence of postanaesthesia respiratory depression in PACU as well as anaesthesia recovery, emergence delirium, postoperative nausea and vomiting, rescue analgesia, duration of PACU and hospital stay, and any other adverse events will be assessed at the given study time point. Investigators performing postoperative follow-up are not involved in both anaesthesia implementation and postoperative care.

Ethics and dissemination

This study protocol has been approved by the ethics board at Xiang’an Hospital of Xiamen University (XAHLL2019003). The results of this study will be published in a peer-review journal and presented at national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication.

Trial registration number

ChiCTR2000031087.

Two-field non-mydriatic fundus photography for diabetic retinopathy screening: a protocol for a systematic review and meta-analysis

Por: Yu · D. · Dou · X. · Chen · J. · Lu · Y. · Ye · B. · Wu · X. · Wu · Z. · Li · Q. · Tian · X. · Zhou · B. · Deng · Y. · Li · W. · Hu · X. · Mou · L. · Pu · Z.
Introduction

Diabetic retinopathy (DR) is one of the most prevalent microvascular complications of diabetes mellitus. Guidelines for DR screening in different countries vary greatly, including fundus photography, slit-lamp biomicroscopy, indirect ophthalmoscopy, Optical Coherence Tomography (OCT), OCT-A and Fundus Fluorescein Angiography (FFA). Two-field non-mydriatic fundus photography (NMFP) is an effective screening method due to its low cost and less time-consuming process. However, it is controversial due to the sensitivity and specificity of two-field NMFP. This review intends to evaluate the performance of the two-field NMFP in diagnosing DR and helps clinicians determine the most optimal screening method.

Methods and analysis

Two reviewers will independently search on the Medline, Embase, Cochrane databases, ProQuest, Opengrey, Chinese National Knowledge Infrastructure, Wanfang Data, VIP China Science and Technology Journal Database, Chinese BioMedical Literature Database, ISRCTN, ClinicalTrials.gov and the WHO ICTRP to identify relevant studies. There is no restriction posed on the language of the study. Included studies focus on the performance of two-field NMFP in detecting DR in diabetes patients. Analysis and evaluation of the studies will be examined by two reviewers independently using the Quality Assessment for Diagnostic Accuracy Studies-2 tool and later evaluated using the Population, Intervention, Comparison, Outcome, Study design criteria. A random-effect model will calculate the diagnostic indicators, including the sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic OR, area under the curve and 95% CIs. We will also develop a summary receiver operating characteristic curve. We anticipate analysing subgroups according to the factors, which may lead to heterogeneity, including DR levels of patients, the reference standards, camera models, the interpretation criteria. The data will be analysed by STATA software. This study was registered with PROSPERO.

Ethics and dissemination

This review will analyse the published data. Patients/the public were not involved in this research. The results of this study will be published in peer-reviewed journals.

PROSPERO registration number

CRD42020203608.

Modified effect of active or passive smoking on the association between age and abdominal aortic calcification: a nationally representative cross-sectional study

Por: Lv · L. · Wu · S. · Yang · Y. · Yue · X.
Objective

The deleterious effects of smoking on atherosclerosis were well known; however, the interaction among ageing, smoking and atherosclerosis remains unclear. This study tested the hypothesis that the association between age and vascular calcification, a critical mark of atherosclerosis, was modified by smoking.

Design

Cross-sectional study.

Setting

A nationally representative sample, the National Health and Nutrition Examination Surveys 2013–2014.

Participants

This study included 3140 adults aged 40–80 years with eligible data for abdominal aortic calcification (AAC). Active and passive smoking exposure was identified through self-reports and tobacco metabolites (serum cotinine and urinary 4-methylnitrosamino-3-pyridyl-1-butanol).

Primary outcome measures

AAC score was determined using dual-energy X-ray absorptiometry (DXA) scans. OR was estimated using the logistic regression method to assess the association between age and the presence of severe or subclinical AAC stratified by smoking exposure. The survey-weighted Wald test was used to evaluate potential interactions.

Results

AAC was positively associated with age in the general population. After adjustment for age, sex, race/ethnicity and other cardiovascular risk factors, age was significantly associated with the odds of severe AAC (OR for each 5-year increase in age: 1.66, 95% CI 1.48 to 1.87, p

Conclusions

Smoking significantly accelerated the progression of age-related subclinical atherosclerosis. Early smoking cessation should be encouraged among young smokers. The effect of passive smoking exposure on arteriosclerosis should be assessed further.

Associations between urinary cysteine-rich protein 61 excretion and kidney function decline in outpatients with chronic kidney disease: a prospective cohort study in Taiwan

Por: Lai · C.-F. · Wang · J.-J. · Tu · Y.-C. · Hsu · C.-Y. · Wu · H.-Y. · Fang · C.-C. · Chen · Y.-M. · Wu · M.-S. · Tsai · T.-J.
Objectives

To examine whether urinary excretion of cysteine-rich protein 61 (Cyr61), an acknowledged proinflammatory factor in kidney pathologies, increases in chronic kidney disease (CKD) and is associated with subsequent rapid kidney function decline.

Design

An observational cohort study.

Setting

In the nephrology outpatient clinics of a tertiary hospital in Taiwan.

Participants

We enrolled 138 adult CKD outpatients (n=12, 32, 18, 18, 29 and 29 in stages 1, 2, 3a, 3b, 4 and 5 CKD, respectively) between February and October 2014 and followed them for 1 year. Their mean age was 60.46±13.16 years, and 51 (37%) of them were women.

Primary outcome measures

Urinary Cyr61 levels were measured by ELISA. Rapid kidney function decline was defined as an estimated glomerular filtration rate (eGFR) decline rate ≥ 4 mL/min/1.73 m2/year or developing end-stage renal disease during subsequent 3-month or 1-year follow-up period. Models were adjusted for demographic and clinical variables.

Results

The urine Cyr61-to-creatinine ratio (UCyr61CR) increased significantly in patients with stage 4 or 5 CKD. Multivariable linear regression analysis showed that log(UCyr61CR) was positively correlated with log(urine protein-to-creatinine ratio) (p

Conclusions

Elevated urinary Cyr61 excretion is associated with rapid short-term kidney function deterioration in patients with CKD. Measuring urinary Cyr61 excretion is clinically valuable for monitoring disease trajectory and may guide treatment planning.

Patient empowerment and self‐management behaviour of chronic disease patients: A moderated mediation model of self‐efficacy and health locus of control

Abstract

Aims

To explore the role of self-efficacy (SE) in the effect of patient empowerment on self-management behaviours among patients with chronic illness and to investigate the moderating effect of three types of health locus of control (HLC) in this moderated mediation model.

Design

Cross-sectional design.

Methods

Data were collected in a general tertiary hospital, and a sample of 254 patients was recruited between August and October 2020. The effect of moderation and mediation was tested by the PROCESS macro (Model 4 and Model 8) for SPSS 25.0 by Hayes using 5000 bootstrap samples.

Results

Self-efficacy significantly mediated the relationship between patient empowerment and self-management behaviour with a 95% confidence interval excluding zero. The chance HLC demonstrated a moderating effect, and the interaction effect on SE and self-management behaviour was significant.

Conclusion

Patient empowerment may improve confidence and adherence to self-management among people with chronic illness, and such benefits were conditional on the HLC of patients.

Impact

This study addresses the relationship between patient empowerment and self-management behaviour in patients with different personality characteristics. This result indicated that classifying the type of HLC may enable the identification of subgroups of patients who may subsequently benefit from patient empowerment. In a patient-centred programme, nurses and other healthcare professionals correctly identifying patients’ HLC type and understanding the implications and then providing appropriate health care plans for patients with different health beliefs may be useful to tailor the decision-making process.

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