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☐ ☆ ✇ BMJ Open

Intervention of muscle-building and antifrailty exercise combined with Baduanjin for frailty of different functional levels: study protocol for a randomised controlled trial

Por: Xu · S. · Gong · Z. · Wang · F. · Cao · M. · Liu · J. · Chen · C. · Zhang · N. · Kang · J. · Xu · C. · Peng · N. — Diciembre 15th 2023 at 06:39
Introduction

Frailty has been currently considered as a multidimensional concept, including physical, cognitive and social frailty. Frailty has also been associated with a range of adverse events, which might increase the risks of disability, falls, fractures, delirium and death. Increasing evidence has shown that multicomponent exercise training can improve physical and cognitive function, delay or reverse frailty. However, there is still a lack of exercise intervention programmes for the frail older adults in China. This trial aims to investigate the effects of the muscle-building and antifrailty exercise combined with Baduanjin on the physical function of frail older adults, as well as the effectiveness and safety of the intervention.

Methods and analysis

This study is a prospective randomised controlled trial. A total of 192 patients, aged 70 years or older, who are diagnosed as prefrailty or frailty based on the Fried criteria will be included. Prior written and informed consent will be obtained from every subject. These subjects will be randomly assigned to the exercise intervention group (n=96) and the control group (n=96). The exercise intervention group will undergo different exercise programmes for different levels of physical function. They will perform the muscle-building and antifrailty exercise three times per week for 30–60 min for 24 weeks. The control group will implement health education on frailty and maintain the old lifestyle without any intervention.

The primary outcomes include the change in frailty and functional capacity, assessed according to the Fried Scale and the Short Physical Performance Battery. Secondary outcomes include the changes in body composition, Activities of daily living, Mini-Mental State Examination, The Geriatric Depression Scale-15 and the haematological indicators.

Ethics statement

The study has been approved by the Medical Ethics Committee of the PLA General Hospital (approval no.: S2022-600-02).

Trial registration number

ChiCTR2300070535.

☐ ☆ ✇ BMJ Open

Association of epicardial and visceral adipose tissue in relation to subclinical cardiac dysfunction in Chinese: Danyang study

Por: Yao · F. · Zeng · L. · Hua · M. · Zhang · S. · Liang · J. · Gao · Y. · Chen · C. · Zhao · X. · He · A. · Liu · M. — Diciembre 12th 2023 at 17:17
Objective

Our study aims to examine the associations of visceral adipose tissue (VAT) and epicardial adipose tissue (EAT) with subclinical cardiac dysfunction in a Chinese population.

Design

Cross-sectional.

Background

EAT and VAT are the most important ectopic fat pools which were previously shown to be associated with subclinical cardiac dysfunction. However, few studies simultaneously measured both EAT thickness and VAT area, and explored their associations with cardiac dysfunction. Our study aims to examine the associations of VAT and EAT with subclinical cardiac dysfunction in a Chinese population.

Methods

The study subjects were recruited from Danyang County from 2018 to 2019. Using Philips CX50, we recorded EAT thickness at the end-systole in a long-axis view. The subclinical systolic and diastolic function were assessed by two-dimensional speckle tracking, and transmitral and tissue Doppler imaging, respectively. Using Omron HDS-2000, we measured VAT area by dual bioelectrical impedance analysis.

Results

The 1558 participants (age, 52.3±12.8 years) included 930 (59.7%) women. Compared with women, men had higher VAT area (99.4 vs 70.1 cm2; p

Conclusions

Increased EAT thickness was associated with worse subclinical systolic dysfunction, while greater VAT area was associated with early diastolic dysfunction.

☐ ☆ ✇ BMJ Open

Patterns and predictors of racial/ethnic disparities in HIV care continuum in the Southern USA: protocol for a population-based cohort study

Por: Yang · X. · Zhang · J. · Olatosi · B. · Li · Z. · Weissman · S. · Li · X. — Diciembre 12th 2023 at 17:17
Introduction

Health disparities exist at every step of the HIV care continuum (HCC) among racial/ethnic minority population. Such racial/ethnic disparities may have significantly delayed the progress in HCC in the Southern US states that are strongly represented among geographic focus areas in the 2019 federal initiative titled ‘Ending the HIV Epidemic: A Plan for America’. However, limited efforts have been made to quantify the long-term spatiotemporal variations of HCC disparities and their contributing factors over time, particularly in the context of COVID-19 pandemic. This project aims to identify the spatiotemporal patterns of racial disparities of each HCC outcome and then determine the contribution of contextual features for temporal change of disparities in HCC.

Methods and analysis

This cohort study will use statewide HIV cohort data in South Carolina, including all people living with HIV (PLWH) who were diagnosed with HIV in 2005–2020. The healthcare encounter data will be extracted from longitudinal EHR from six state agencies and then linked to aggregated county-level community and social structural-level data (eg, structural racism, COVID-19 pandemic) from multiple publicly available data sources. The South Carolina Revenue of Fiscal and Affairs will serve as the honest broker to link the patient-level and county-level information. We will first quantify the HCC-related disparities by creating a county-level racial/ethnic disparity index (RDI) for each key HCC outcomes (eg, HIV testing, timely diagnosis), examine the temporal patterns of each RDI over time and then using geographical weighted lasso model examine which contextual factors have significant impacts on the change of county-level RDI from 2005 to 2020.

Ethics and dissemination

The study was approved by the Institutional Review Board at the University of South Carolina (Pro00121718) as a Non-Human Subject study. The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences and through social media.

☐ ☆ ✇ BMJ Open

Impact of smoking cessation on non-alcoholic fatty liver disease prevalence: a systematic review and meta-analysis

Por: Zhang · S. · Liu · Z. · Yang · Q. · Hu · Z. · Zhou · W. · Ji · G. · Dang · Y. — Diciembre 10th 2023 at 15:59
Objectives

The negative effects of smoking on numerous cardiovascular and metabolic diseases have been widely acknowledged. However, the potential effect of smoking cessation is relatively unelucidated. The objective of this study is to explore whether the prevalence of non-alcoholic fatty liver disease (NAFLD) in former smokers differs from the prevalence in current smokers.

Design

Systematic review and meta-analysis.

Data sources

Four databases, that is, PubMed, Web of Science, Journal@Ovid and Scopus were searched from inception to 31 January 2023.

Eligibility criteria

Population-based cross-sectional studies, including the baseline data of cohort studies with identified NAFLD diagnostic methods, and smoking status (current smoker or former smoker) of participants were included.

Data extraction and synthesis

Two reviewers independently extracted the data including cigarette smoking status, country/region of studies, NAFLD diagnostic methods, sex, the average age and body mass index (BMI) of NAFLD participants and assessed the risk of bias with Agency for Healthcare Research and Quality (AHRQ) methodology checklist. Risk ratio (RR) of NAFLD prevalence in former smokers was pooled using the random-effects model.

Results

28 studies involving 4 465 862 participants were included. Compared with current smokers, the RR of overall NAFLD prevalence in former smokers was 1.13 (95% CI: 1.08 to 1.19, prediction interval: 0.92–1.39). This result persisted after adjustment for diagnostic methods, country/region, sex, age and BMI. Sensitivity analysis and risk of bias assessment indicated a stable conclusion.

Conclusions

NAFLD prevalence in former smokers was at least not lower than that in current smokers and was partially related to increased BMI after smoking cessation, indicating that smoking cessation was possibly not a protective factor against NAFLD. Although the meta-analysis based on cross-sectional studies cannot conclude the causal relationships between smoking cessation and NAFLD onset, the potential onset of NAFLD associated with smoking cessation should be highlighted.

PROSPERO registration number

CRD42023394944.

☐ ☆ ✇ BMJ Open

Optimal concentration of ropivacaine for peripheral nerve blocks in adult patients: a protocol for systematic review and meta-analysis

Por: Li · J. · Pan · J. · Xu · Y. · Wang · Y. · Zhang · D. · Wei · Y. — Diciembre 10th 2023 at 15:59
Introduction

Ropivacaine is the most widely used local anaesthetic for peripheral nerve blocks (PNBs). The effects of various concentrations of ropivacaine in PNB have been investigated and compared by many randomised controlled trials (RCTs). This protocol aims to identify the optimal concentration of ropivacaine for PNB in adult patients.

Methods and analysis

PubMed, EMBASE, the Cochrane library and Web of Science will be searched from their inception to 10 July 2023. RCTs that compare the analgesic effects of different concentrations of ropivacaine for PNB will be included. Retrospective studies, meta-analyses, reviews, case reports, letters, conference abstracts and paediatric studies will be excluded. The duration of analgesia will be named as the primary outcome. Secondary outcomes will include the onset time of motor and sensory blockade, postoperative pain scores, analgesic requirements over 24 hours and the incidence of adverse effects. The study selection, data extraction and quality assessment will be performed by two independent reviewers. Data processing and analysis will be performed by RevMan 5.4. The quality of the evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethics and dissemination

Ethical approval is not applicable. The results of this study will be submitted to peer-reviewed journals.

PROSPERO registration number

CRD42023406362.

☐ ☆ ✇ BMJ Open

Rationale and design of a comparison of angiography-derived fractional flow reserve-guided and intravascular ultrasound-guided intervention strategy for clinical outcomes in patients with coronary artery disease: a randomised controlled trial (FLAVOUR II)

Por: Zhang · J. · Hu · X. · Jiang · J. · Lu · D. · Guo · L. · Peng · X. · Pan · Y. · He · W. · Li · J. · Zhou · H. · Huang · J. · Jiang · F. · Pu · J. · Cheng · Z. · Yang · B. · Ma · J. · Chen · P. · Liu · Q. · Song · D. · Lu · L. · Li · S. · Fan · Y. · Meng · Z. · Tang · L. · Shin · E.-S. · Tu · S. · Koo · B.- — Diciembre 10th 2023 at 15:59
Introduction

Percutaneous coronary intervention (PCI) guided by coronary angiography-derived fractional flow reserve (FFR) or intravascular ultrasound (IVUS) has shown improved clinical outcomes compared with angiography-only-guided PCI. In patients with intermediate stenoses, FFR resulted in fewer coronary interventions and was non-inferior to IVUS with respect to clinical outcomes. However, whether this finding can be applied to angiography-derived FFR in significant coronary artery disease (CAD) remains unclear.

Method and analysis

The comparison of angiography-derived FFR-guided and IVUS-guided intervention strategies for clinical outcomes in patients with coronary artery disease (FLAVOUR II) trial is a multicentre, prospective, randomised controlled trial. A total of 1872 patients with angiographically significant CAD (stenoses of at least 50% as estimated visually through angiography) in a major epicardial coronary artery will be randomised 1:1 to receive either angiography-derived FFR-guided or IVUS-guided PCI. Patients will be treated with second-generation drug-eluting stent according to the predefined criteria for revascularisation: angiography-derived FFR≤0.8 and minimal lumen area (MLA)≤3 mm2 or 3 mm22 and plaque burden>70%. The primary endpoint is a composite of all-cause death, myocardial infarction and revascularisation at 12 months after randomisation. We will test the non-inferiority of the angiography-derived FFR-guided strategy compared with the IVUS-guided decision for PCI and the stent optimisation strategy.

The FLAVOUR II trial will provide new insights into optimal evaluation and treatment strategies for patients with CAD.

Ethics and dissemination

FLAVOUR II was approved by the institutional review board at each participating site (The Second Affiliated Hospital of Zhejiang University School of Medicine Approval No: 2020LSYD410) and will be conducted in line with the Declaration of Helsinki. Informed consent would be obtained from each patient before their participation. The study results will be submitted to a scientific journal.

Trial registration number

NCT04397211.

☐ ☆ ✇ BMJ Open

Effectiveness and safety of nintedanib in prevention of pulmonary fibrosis induced by bleomycin in malignant ovarian germ cell tumour: study protocol for a randomised, double-blind, placebo-controlled trial

Por: Li · S. · Zhang · X. · Yin · M. · Zhang · T. · Zhang · R. · Yang · J. · Yang · J. — Diciembre 10th 2023 at 15:59
Introduction

Bleomycin is a crucial and irreplaceable chemotherapy regimen for malignant ovarian germ cell tumours (MOGCTs) but its toxicities especially pulmonary fibrosis have limited the dose of treatment efficacy and decreased the patients’ quality of life (QoL). Nintedanib has been approved for treating progressive fibrosing interstitial lung diseases and has shown potential anti-tumour effects. This study aims to evaluate the effectiveness and safety of nintedanib in the prevention of pulmonary fibrosis induced by bleomycin in MOGCTs patients.

Methods and analysis

This is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. We will enrol a total of 128 patients who will be randomly assigned to the nintedanib group and placebo group in a 1:1 ratio. Standard bleomycin, etoposide and cisplatin chemotherapy will be given to each MOGCT patient. In addition, patients assigned to nintedanib and the control group will be given oral nintedanib 150 mg two times per day and placebo one tablet two times per day until 1 month after the last cycle of bleomycin therapy, respectively. The primary outcome is the decline of forced vital capacity (FVC). The secondary outcomes are the decline of other pulmonary function indices (forced expiratory volume in 1 s; FVC pred%, carbon monoxide diffusion capacity) and the patients’ QoL, oncological and fertility outcomes. We will use electronic case report forms to record all the participants’ data and SPSS V.27.0/STATA V.16.0/Graphpad Prism V.8.0 to conduct statistical analysis.

Ethics and dissemination

The Ethics Committee of Peking Union Medical College Hospital has approved the study (I-23PJ400). Written informed consent will be obtained from all participants/guardians. Study results will be submitted to peer-reviewed medical journals for publication and presented at academic conferences.

Trial registration number

ChiCTR2300070492.

☐ ☆ ✇ BMJ Open

Effects of the different intensities of task-oriented training on the upper extremity motor function and self-care ability of stroke survivors: study protocol for a multiarm parallel-group randomised controlled trial in a tertiary hospital in China

Por: Liu · S. · Zhang · K. · Li · X. · Li · C. · Peng · M. — Diciembre 9th 2023 at 17:51
Introduction

Although task-oriented training (TOT) may provide added therapeutic value to stroke survivors, current TOT guidance offers insufficient advice on standardisation, particularly choices of intensity, for clinical practice. Therefore, this study aims to explore the effects of different intensities of TOT on motor function and self-care ability of stroke survivors.

Methods and analysis

This randomised controlled clinical trial will recruit 72 participants from a tertiary hospital, diagnosed with decreased self-care ability and upper limb motor dysfunction post-stroke. All participants will be randomly assigned to one of three experimental groups or the control group to undergo intervention for 8 weeks. The participants in the control group (n=18) will receive traditional occupational therapy, while those in the experimental groups will receive different intensities of TOT (50%, 75% and 100% intensity for groups A, B and C, respectively). This protocol designed a more innovative and optimised TOT programme to explore the optimal intensity of TOT on stroke survivors. The primary outcome is Canadian Occupational Performance Measure, and the secondary outcomes include Modified Barthel Index, Wolf Motor Function Test and Motor Activity Log.

Ethics and dissemination

The Second Affiliated Hospital of Hainan Medical University Ethics Committee approved the medical and ethical protocol for this study (LW2022015). All participants will sign an informed consent form. The results will be presented in scientific conferences and published in peer-reviewed journals.

Trial registration number

ChiCTR2200056390.

☐ ☆ ✇ BMJ Open

Predictive value of machine learning on fracture risk in osteoporosis: a systematic review and meta-analysis

Por: Wu · Y. · Chao · J. · Bao · M. · Zhang · N. — Diciembre 9th 2023 at 17:51
Objectives

Early identification of fracture risk in patients with osteoporosis is essential. Machine learning (ML) has emerged as a promising technique to predict the risk, whereas its predictive performance remains controversial. Therefore, we conducted this systematic review and meta-analysis to explore the predictive efficiency of ML for the risk of fracture in patients with osteoporosis.

Methods

Relevant studies were retrieved from four databases (PubMed, Embase, Cochrane Library and Web of Science) until 31 May 2023. A meta-analysis of the C-index was performed using a random-effects model, while a bivariate mixed-effects model was used for the meta-analysis of sensitivity and specificity. In addition, subgroup analysis was performed according to the types of ML models and fracture sites.

Results

Fifty-three studies were included in our meta-analysis, involving 15 209 268 patients, 86 prediction models specifically developed for the osteoporosis population and 41 validation sets. The most commonly used predictors in these models encompassed age, BMI, past fracture history, bone mineral density T-score, history of falls, BMD, radiomics data, weight, height, gender and other chronic diseases. Overall, the pooled C-index of ML was 0.75 (95% CI: 0.72, 0.78) and 0.75 (95% CI: 0.71, 0.78) in the training set and validation set, respectively; the pooled sensitivity was 0.79 (95% CI: 0.72, 0.84) and 0.76 (95% CI: 0.80, 0.81) in the training set and validation set, respectively; and the pooled specificity was 0.81 (95% CI: 0.75, 0.86) and 0.83 (95% CI: 0.72, 0.90) in the training set and validation set, respectively.

Conclusions

ML has a favourable predictive performance for fracture risk in patients with osteoporosis. However, most current studies lack external validation. Thus, external validation is required to verify the reliability of ML models.

PROSPERO registration number

CRD42022346896.

☐ ☆ ✇ BMJ Open

Prevalence and related factors of children myopia in Pudong New Area, Shanghai: a cross-sectional study

Por: Cheng · P. · Zhang · X. · Zhou · W. · Xu · J. · Chen · F. · Qian · D. · Cao · B. — Diciembre 9th 2023 at 17:51
Objectives

This study aimed to assess the prevalence and related factors of myopia among school-aged children after COVID-19 pandemic.

Design

Cross-sectional study.

Setting

Pudong New Area, Shanghai.

Participants

1722 children aged 7–9 randomly selected from 8 primary schools were screened from 1 February 2023 to 30 April 2023.

Main outcome measures

Children’s height, weight and eye parameters were examined. Myopia was defined as a cycloplegic spherical equivalent ≤–0.50 dioptres in either eye. A vision-related behaviour questionnaire was applied to investigate the associations between myopia and its risk factors.

Results

Of the 1722 individuals enrolled, 25.6% (456) had myopia. After adjusting other characteristics, the following factors were associated with an increased rate of myopia: age (9 years vs 7 years, adjusted OR (AOR) 1.84, 95% CI 1.18 to 2.85, p=0.007), parental myopia status (both myopia vs none, AOR 5.66, 95% CI 3.71 to 8.63, p

Conclusions

The prevalence of myopia is of concern among young school-aged children after COVID-19. Correcting eye use behaviour and improving sleep habits may reduce myopia. Also, gender differences should be considered in prevention strategies for children’s myopia.

☐ ☆ ✇ BMJ Open

Effects of non-invasive brain stimulation over supplementary motor area in people with Parkinsons disease: a protocol for a systematic review and meta-analysis of randomised controlled trials

Por: Wei · Y. · Ye · S. · Jiang · H. · Chen · Y. · Qiu · Y. · Zhang · L. · Ma · R. · Gao · Q. — Diciembre 9th 2023 at 17:51
Introduction

Individuals with Parkinson’s disease (PD) often experience initial hesitation, slowness of movements, decreased balance and impaired standing ability, which can significantly impact their independence. Transcranial magnetic stimulation and transcranial direct current stimulation are two widely used and promising non-invasive brain stimulation (NIBS) modalities for treating PD. The supplementary motor area (SMA), associated with motor behaviour and processing, has received increasing attention as a potential stimulation target to alleviate PD-related symptoms. However, the data on NIBS over SMA in PD individuals are inconsistent and has not been synthesised. In this article, we will review the evidence for NIBS over SMA in PD individuals and evaluate its efficacy in improving PD function.

Method and analysis

Randomised controlled clinical trials comparing the effects of NIBS and sham stimulation on motor function, activities of daily living and participation for people with PD will be included. A detailed computer-aided search of the literature will be performed from inception to February 2023 in the following databases: PubMed, EMBASE, Physiotherapy Evidence Database (PEDro), Web of Science (WOS) and The Chinese National Knowledge Infrastructure (CNKI). Two independent reviewers will screen articles for relevance and methodological validity. The PEDro scale will be used to evaluate the risk of bias of selected studies. Data from included studies will be extracted by two independent reviewers through a customised, preset data extraction sheet.

Ethics and dissemination

Ethical approval is not required for this systematic review. The study’s findings will be presented at scientific meetings and published in peer-reviewed journals.

PROSPERO registration number

CRD42023399945.

☐ ☆ ✇ BMJ Open

Differentiating Alzheimers disease from mild cognitive impairment: a quick screening tool based on machine learning

Por: Lü · W. · Zhang · M. · Yu · W. · Kuang · W. · Chen · L. · Zhang · W. · Yu · J. · Lü · Y. — Diciembre 9th 2023 at 17:51
Background

Alzheimer’s disease (AD) is a neurodegenerative disorder characterised by cognitive decline, behavioural and psychological symptoms of dementia (BPSD) and impairment of activities of daily living (ADL). Early differentiation of AD from mild cognitive impairment (MCI) is necessary.

Methods

A total of 458 patients newly diagnosed with AD and MCI were included. Eleven batteries were used to evaluate ADL, BPSD and cognitive function (ABC). Machine learning approaches including XGboost, classification and regression tree, Bayes, support vector machines and logical regression were used to build and verify the new tool.

Results

The Alzheimer’s Disease Assessment Scale (ADAS-cog) word recognition task showed the best importance in judging AD and MCI, followed by correct numbers of auditory verbal learning test delay recall and ADAS-cog orientation. We also provided a selected ABC-Scale that covered ADL, BPSD and cognitive function with an estimated completion time of 18 min. The sensitivity was improved in the four models.

Conclusion

The quick screen ABC-Scale covers three dimensions of ADL, BPSD and cognitive function with good efficiency in differentiating AD from MCI.

☐ ☆ ✇ BMJ Open

Predictive factors of poor outcome and mortality among anterior ischaemic stroke patients despite successful recanalisation in China: a secondary analysis of the CAPTURE trial

Por: Li · G. · Sun · Y. · Liu · T. · Yang · P. · Peng · Y. · Chen · W. · Zhang · L. · Chu · J. · Kuai · D. · Wang · Z. · Wu · W. · Xu · Y. · Zhou · B. · Geng · Y. · Yin · C. · Li · J. · Wang · M. · Peng · X. · Xiao · Y. · Li · M. · Zhang · X. · Liu · P. · Wang · N. · Zhang · Y. — Diciembre 9th 2023 at 17:51
Objectives

This work aimed to analyse the risk factors for poor outcomes and mortality among patients with anterior large vessel occlusion (LVO) ischaemic stroke, despite successful recanalisation.

Setting and participants

This study conducted a secondary analysis among patients who underwent successful recanalisation in the CAPTURE trial. The trial took place between March 2018 and September 2020 at 21 sites in China. The CAPTURE trial enrolled patients who had an acute ischaemic stroke aged 18–80 years with LVO in anterior circulation.

Interventions

Thrombectomy was immediately performed using Neurohawk or the Solitaire FR after randomisation in CAPTURE trial. Rescue treatment was available for patients with severe residual stenosis caused by atherosclerosis.

Primary and secondary outcome measures

The primary goal was to predict poor 90-day survival or mortality within 90 days post-thrombectomy. Univariate analysis, using the 2 test or Fisher’s exact test, was conducted for each selected factor. Subsequently, a multivariable analysis was performed on significant factors (p≤0.10) identified through univariate analysis using the backward selection logistic regression approach.

Results

Among the 207 recruited patients, 79 (38.2%) exhibited poor clinical outcomes, and 26 (12.6%) died within 90 days post-thrombectomy. Multivariate analysis revealed that the following factors were significantly associated with poor 90-day survival: age ≥67 years, internal carotid artery (ICA) occlusion (compared with middle cerebral artery (MCA) occlusion), initial National Institutes of Health Stroke Scale (NIHSS) score ≥17 and final modified Thrombolysis in Cerebral Infarction (mTICI) score 2b (compared with mTICI 3). Additionally, the following factors were significantly associated with mortality 90 days post-thrombectomy: initial NIHSS score ≥17, ICA occlusion (compared with MCA occlusion) and recanalisation with more than one pass.

Conclusions

Age, NIHSS score, occlusion site, mTICI score and the number of passes can be independently used to predict poor 90-day survival or mortality within 90 days post-thrombectomy.

Trial registration number

NCT04995757.

☐ ☆ ✇ BMJ Open

Preventive strategies for low anterior resection syndrome: a protocol for systematic review and evidence mapping

Por: Zhang · X.-Y. · Yang · K.-L. · Li · Y. · Li · R.-S. · Wang · S.-Q. · Liu · X.-N. · Wang · Q. — Diciembre 1st 2023 at 16:59
Introduction

Rectal cancer is one of the top 10 cancers worldwide. Up to 80% of patients with rectal tumours have had sphincter-saving surgery, mainly due to the large expectation of anal preservation. However, patients tend to experience low anterior resection syndrome (LARS) after rectal resection, which is disordered bowel function that includes faecal incontinence, urgency, frequent defecation, constipation and evacuation difficulties. LARS, with an estimated prevalence of 41%, has been reported to substantially decrease the quality of life of patients. However, no comprehensive preventive strategies are currently available for LARS. This systematic review aims to synthesise evidence on the current LARS preventive strategies.

Methods and analysis

This protocol is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) checklist. Literature in PubMed (via Medline), Embase and the Cochrane Library from inception to July 2023 will be searched to identify articles relevant to preventive effectiveness against LARS. The Cochrane Collaboration’s risk of bias tool for randomised controlled trials and the Newcastle-Ottawa Scale for clinical controlled trials, cohort studies and case–control studies will be used to assess the risk of bias. We will group the included studies by the type of LARS prevention strategy and present an overview of the main findings in the form of evidence mapping. A meta-analysis is planned if there is no substantial clinical heterogeneity between the included studies. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) will be used to evaluate the quality of the evidence.

Ethics and dissemination

Ethical approval is not needed for systematic review of published data. The findings will be published in a peer-reviewed journal and disseminated at scientific conferences.

PROSPERO registration number

CRD42023402886.

☐ ☆ ✇ BMJ Open

Relationship Between Birth Weight and Asthma Diagnosis: A Cross-Sectional Survey Study Based on the National Survey of Childrens Health in the U.S.

Por: Ni · M. · Li · B. · Zhang · Q. · Zhao · J. · Li · W. · Qi · S. · Shen · Q. · Yao · D. · Chen · Z. · Wang · T. · Ding · X. · Lin · Z. · Cheng · C. · Liu · Z. · Chen · H. — Diciembre 1st 2023 at 16:59
Objective

To assess the association between birth weight and childhood asthma risk using data from the 2019–2020 National Survey of Children’s Health database.

Design

Cross-sectional study.

Setting

The USA.

Patients

A representative cohort of American children.

Exposure

The exposure of this study was birth weight regardless of gestational age. Birth weight was divided into three groups: 2500 g.

Main outcome measures

Primary outcomes were parent-reported diagnosis of asthma.

Method

The Rao-Scott 2 test was used to compare the groups. The main analyses examined the association between birth weight and parent-report asthma in children using univariable and multivariable logistic models adjusting for preterm birth, age, sex, race, family poverty, health insurance, smoking, maternal age. Subgroup analysis was performed based on interaction test.

Results

A total of 60 172 children aged 3–17 years were enrolled in this study; of these, 5202 (~8.6%) had asthma. Children with asthma were more likely to be born preterm, with low birth weight (LBW) or very LBW (VLBW). The incidence of asthma was the highest in VLBW children at 20.9% and showed a downward trend with an increase in birth weight class, with rates of 10.7% and 8.1% in the LBW and normal birthweight groups, respectively. Children with VLBW (OR 1.97; 95% CI 1.29 to 3.01) had higher odds of developing asthma in the adjusted analysis model. However, VLBW was only shown to be a risk factor for asthma among Hispanics, black/African-Americans and children between the ages of 6 and 12 years, demonstrating racial and age disparities.

Conclusions

VLBW increases the risk of childhood asthma; however, racial and age disparities are evident.

☐ ☆ ✇ BMJ Open

Association between leisure sedentary behaviour and uterine fibroids in non-menopausal women: a population-based study

Por: Sun · Y. · Han · X. · Hou · Z. · Deng · H. · Cheng · N. · Zhang · N. · Zhang · J. · Li · Y. · Wang · Q. · Yin · J. · Meng · Q. — Noviembre 29th 2023 at 00:30
Objective

Sedentary behaviour is associated with a variety of adverse health outcomes, including obesity, oestrogen metabolism and chronic inflammation, all of which are related to the pathogenesis of uterine fibroids (UFs). This study aimed to explore the relationship between leisure sedentary time (LST) and UFs.

Design

Cross-sectional.

Setting

We conducted a cross-sectional analysis of data from patients from the Yunnan region in the China Multi-Ethnic Cohort Study.

Participants

A total of 6623 non-menopausal women aged 30–55 years old were recruited. Menstrual status was self-reported. Participants who lacked a unique national identity card, suffered from serious mental illness, did not have a clear diagnosis of UFs, or provided incomplete information were excluded.

Primary and secondary outcome

UFs were diagnosed by abdominal B-ultrasound. Leisure sedentary behaviour was assessed by using a face-to-face questionnaire interview. Logistic regression and restricted cubic spline were employed to explore the relationship between LST and UFs.

Results

A total of 562 participants had UFs, with a prevalence rate of 8.5% (7.8%, 9.2%). Multivariate adjusted logistic regression analysis showed that the risk of UFs in women with LST≥6 hour/day was 2.008 times that in women with LST0.05). According to the results of the stratified analysis for menstrual status and body mass index (BMI), there was a correlation between LST and the prevalence of UFs only in women with a BMI2 or perimenopause.

Conclusion

LST was independently associated with the prevalence of UFs, and a linear dose-response relationship was observed. Our study provides evidence on the factors influencing UFs, and further research is needed to propose feasible measures for UFs prevention.

☐ ☆ ✇ BMJ Open

Comparison of drug-coated balloon angioplasty versus standard medical therapy on recurrent stroke and mortality rates among patients with symptomatic intracranial atherosclerotic stenosis: protocol for a systematic review and meta-analysis

Por: Sun · Y. · Luo · J. · Gong · H. · Xu · R. · Zhang · X. · Yang · B. · Ma · Y. · Wang · T. · Jiao · L. — Noviembre 28th 2023 at 15:15
Introduction

Stroke remains the second leading cause of death worldwide, a common cause of which is intracranial atherosclerotic stenosis (ICAS). Medical treatment is recommended as first-line therapy for treating ICAS, but the recurrence rate remains high. Drug-coated balloon (DCB) angioplasty has been designed to lower the risk of recurrent stenosis, holding therapeutic promise in the treatment of ICAS. However, the benefits of DCB require further evaluation.

Methods and analysis

The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols was followed to develop this protocol. We will systematically search online databases including Cochrane Central Register of Controlled Trials, PubMed, Web of Science, EMBASE, China Biological Medicine Database, ClinicalTrials.gov and WHO ICTRP from 1 January 2011 to the date of search. This will be supplemented by a manual search of unpublished and ongoing trials to manually select articles for inclusion. Inclusion criteria are randomised or quasi-randomised clinical trials and observational studies that investigated DCB or medical treatment for patients with a symptomatic ICAS of 50%–99%. The primary outcome is short-term composite safety including death of any cause, or non-fatal stroke. Secondary outcomes include long-term death or stroke, restenosis, neurological rehabilitation, quality of life and other complications. The available data will be analysed using meta-analysis, if appropriate. The evaluation of heterogeneity and biases will be guided by the Cochrane Handbook for Systematic Reviews of Interventions.

Ethics and dissemination

This systematic review does not require ethical approval as all available data from eligible studies will be anonymous with no concerns regarding privacy. Our findings will be disseminated through international conferences and peer-reviewed publications. Additional data from the study are available on request to corresponding authors via email.

PROSPERO registration number

CRD42022341607.

☐ ☆ ✇ BMJ Open

Combination of computed tomography measurements and flexible video bronchoscope guidance for accurate placement of the right-sided double-lumen tube: a randomised controlled trial

Por: Li · J. · Qian · Y. · Lei · Y. · Huo · W. · Xu · M. · Zhang · Y. · Ji · Q. · Yang · J. · Liu · H. · Hou · Y. — Noviembre 27th 2023 at 17:08
Objective

To compare the modified strategy for the right-sided double-lumen tube (R-DLT) placement using a combination of CT measurements and flexible video bronchoscopy guidance with traditional bronchoscopy technique.

Trial design, setting and participants

Double-blind, parallel randomised control trial at a tertiary care medical centre in China. 100 patients undergoing video-assisted thoracoscopic surgery and requiring R-DLT were randomly allocated to the control group and the intervention group.

Intervention

The control group used the traditional bronchoscopy-guided technique. In the intervention group, the length and anteroposterior diameter of the right main bronchus (RMB) were measured on CT images to select the side and size of the Rüsch tube, and then a black depth marker was placed on the tube according to the difference between the length of the RMB and the bronchial cuff. Under the guidance of bronchoscopy, the depth marker should be placed parallel to the tracheal carina and a characteristic white line on the tube should be parallel to the midline of the tracheal carina.

Main outcomes

The primary endpoint was the positioning of right upper lobe (RUL) ventilatory slot and RUL bronchial orifice. The secondary endpoints included intubation data and perioperative adverse events.

Results

Compared with the control group, our modified strategy significantly increased the optimal and acceptable position rate (76% vs 98%, respectively; p

Conclusion

This study demonstrates the superiority of our strategy and provides a new viable method for R-DLT placement.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR1900021676).

☐ ☆ ✇ BMJ Open

Efficacy of a modified twin block appliance compared with the traditional twin block appliance in children with hyperdivergent mandibular retrognathia: protocol for a single-centre, single-blind, randomised controlled trial

Por: Liu · A. · Zhang · W. · Zhang · W. · Shi · S. · Chen · Z. · Liu · Y. · Lu · Y. — Noviembre 27th 2023 at 17:08
Introduction

Compensatory mouth breathing, caused by nasopharyngeal obstructive diseases, is the main cause of hyperdivergent mandibular retrognathia in children. Such deformities require effective growth guidance before pubertal growth peaks. The traditional mandibular advancement device, twin block (TB), can guide the forward development of the mandible. However, the side effect of increasing the vertical dimension of the lower facial third, worsens the facial profile of children with divergent growth trends. To solve this problem, a modified TB (LLTB) appliance was designed to control the vertical dimension by intruding incisors and inhibiting the elongation of posterior teeth during the advancement of the mandible, which could avoid the side effects of traditional appliances and effectively guide the growth of the mandible in a normal direction.

Methods and analysis

The study was designed as a single-centre, single-blind, randomised, parallel controlled trial. We aim to enrol 60 children aged 9–14 years with hyperdivergent skeletal class II malocclusion, using a 1:1 allocation ratio. The participants were will be randomly assigned to receive either the TB or LLTB treatment. The primary outcome will be a change in the angle of the mandibular plane relative to the anterior cranial base. The secondary outcomes will include changes in the sagittal maxillomandibular relation, occlusal plane, facial height, morphology of the mandible and upper airway width. Safety endpoints will also be evaluated.

Ethics and dissemination

Ethical approval was obtained from the ethics committee of Shanghai Stomatological Hospital. Both participants and their guardians will be fully informed of the study and sign an informed consent form before participating in the trial. The results will be publicly available in peer-reviewed scientific journals.

Trial registration number

ChiCTR2000035882.

☐ ☆ ✇ BMJ Open

Chronic kidney disease and functional impairment in a longitudinal study of older adults in China

Por: Duan · X. · Wang · L. · Wei · W. · Wang · Z. · Zhang · X. · Liu · J. · Ding · D. — Noviembre 27th 2023 at 17:08
Objectives

To examine the associations of chronic kidney disease (CKD) with dynamic functional impairment among older Chinese adults.

Design

This was a prospective longitudinal study.

Setting

Data were derived from the Chinese Longitudinal Healthy Longevity Study.

Participants

All adults aged ≥60 years were potentially eligible. This study included 2970 participants.

Primary outcome measures

CKD was defined as an estimated glomerular filtration rate 2. Functional performances included instrumental activities of daily living (IADL) and basic activities of daily living (BADL), which were measured using six daily activities, including eating, dressing, transferring, using the toilet, bathing and continence, and eight daily activities, including visiting neighbours, shopping, cooking, washing clothes, walking 1 km, lifting 5 kg, crouching and standing up three times and taking public transportation, respectively.

Results

This study included 2970 participants, including 988 (33.60%) participants with CKD. Participants with CKD had higher IADL scores than those without CKD (β=0.895, 95% CI: 0.761 to 1.029). Furthermore, there was a significant linear trend in the association of CKD severity with the IADL score (pβ=0.067, 95% CI: 0.017 to 0.118). However, only participants with moderate and advanced CKD had a higher BADL score (β=0.088 and 0.152, 95% CI: 0.006 to 0.171 and 0.019 to 0.286, respectively).

Conclusions

CKD was associated with worse functional impairment. Furthermore, there was a significant linear trend in the association of the severity of CKD with the IADL score. However, only participants with moderate and advanced CKD had higher BADL scores.

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