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AnteayerBMJ Open

Association between the number of retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer: a systematic review and meta-analysis

Por: Liu · Q. · Huang · M. · Yang · J. · Jiang · M. · Zhao · Z. · Zhao · H. · He · T. · Bai · Y. · Zhang · R. · Zhang · M.
Objective

Clinical practice guidelines recommend retrieving at least 12 lymph nodes for correct staging in colorectal cancer. However, it is difficult to retrieve adequate lymph nodes because of various factors. We aimed to evaluate the association between the number of retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer.

Design

Systematic review and meta-analysis of primary studies.

Data sources

PubMed, Embase, Cochrane and Web of Science were searched from January 2016 to June 2023.

Eligibility criteria for selecting studies

Studies that evaluated the association between retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer were included.

Data extraction and synthesis

OR with 95% conference intervals was extracted and pooled.

Results

A total of 54 studies containing 2 05 821 patients were included in this meta-analysis. The results showed that fewer nodes were retrieved from elderly patients (OR=0.70, 95% CI (0.54 to 0.90), p=0.005), and from tumours located in the left colon than in the right colon (OR=0.43, 95% CI (0.33 to 0.56), p

Conclusions

The study results suggest that clinicians have an increased opportunity to retrieve sufficient lymph nodes for accurate pathological staging to guide treatment decisions in patients with colorectal cancer who are young, female, with tumours located in the right colon, advanced T stage and N2 stage.

Protocol for the PORT study: short-term perioperative rehabilitation to improve outcomes in cardiac valvular surgery - a randomised control trial

Por: Zhou · H. · Liu · F. · Liu · Y. · He · X. · Ma · H. · Xu · M. · Wang · H. · Zhang · G. · Cai · X. · Chen · J.-Y. · Guo · L. · Chen · J.
Introduction

Perioperative rehabilitation (PORT) has shown a positive effect on patients undergoing cardiac surgery. However, there are minimal data on the impact of short-term PORT in cardiac surgery, which is associated with higher postoperative morbidity and mortality. The trial will assess the efficacy of short-term PORT in reducing in-hospital mortality, postoperative pulmonary complications and length of stay, compared with the usual care in cardiac surgical patients.

Methods and analysis

This is a single-centre prospective, randomised, open, controlled trial with a 1:1 ratio. Consecutive 800 adult patients undergoing elective valve surgery will be randomised to either usual care or in-hospital short-term PORT that consists of education, inspiratory muscle training, active cycle of breathing techniques and early mobilisation. The primary outcome of this study will be a composite of in-hospital all-cause mortality, incidence of postoperative pulmonary complications and the ratio of postoperative hospitalisation >7 days.

Ethics and dissemination

The PORT study was granted by the Medical Research Ethics Committee of Guangdong Provincial People’s Hospital in August 2018. Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publication.

Trial registration number

NCT03709511.

Innovative Telerehabilitation Enhanced Care Programme (ITECP) in young and middle-aged patients with haemorrhagic stroke to improve exercise adherence: protocol of a multicentre randomised controlled trial

Por: Zhang · Y. · Jin · Q. · Ji · C. · Yuan · P. · Chen · L.
Introduction

Exercise rehabilitation is crucial for promoting the rehabilitation of limb motor function in people who had stroke and is related to a better prognosis. However, the exercise adherence of patients is low, which affects the effect of exercise rehabilitation. This study aims to evaluate the effects of the Innovative Telerehabilitation Enhanced Care Programme (ITECP) on exercise adherence in young and middle-aged patients with haemorrhagic stroke. We hypothesise that patients trained with ITECP will show greater improvement in exercise adherence and muscle strength than patients with routine exercise rehabilitation.

Methods and analysis

This is a randomised controlled, evaluator-blinded multicentre superiority trial to be implemented at four tertiary grade-A hospitals in eastern, western, northern and central China. Patients in the experimental group will receive ITECP while those in the control group will receive routine exercise rehabilitation. Both groups will receive routine care. The primary outcome measure is exercise adherence, while secondary outcome measures include muscle strength, activities of daily living, exercise self-efficacy, quality of life, rate of exercise-related adverse events and readmission. These will be measured at baseline, predischarge as well as 1 and 3 months postdischarge.

Ethics and dissemination

The study has obtained ethical approval from the Medical Ethics Committee of Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (2021-381-02). The results will be shared with young and middle-aged patients with haemorrhagic stroke, policy-makers, the general public, as well as academia.

Trial registration number

Chinese Clinical Trials Registry (ChiCTR 2200066498).

Nationwide survey of physicians familiarity and awareness of diabetes guidelines in China: a cross-sectional study

Por: Jia · L.-y. · Huang · C.-x. · Zhao · N.-j. · Lai · B.-y. · Zhang · Z.-h. · Li · L. · Zhan · N. · Lin · Y.-b. · Cai · M.-n. · Wang · S.-q. · Yan · B. · Liu · J.-p. · Yang · S.-y.
Objective

This study aims to investigate physicians’ familiarity and awareness of four diabetes guidelines and their practice of the recommendations outlined in these guidelines.

Design

A cross-sectional study.

Setting

An online questionnaire survey was conducted among physicians affiliated with the Specialist Committee for Primary Diabetes Care of China Association of Chinese Medicine, using the snowball sampling method to ensure a broader representation of physicians.

Participants

1150 physicians from 192 cities across 30 provinces in China provided complete data.

Results

Tertiary care hospital physicians (TCPs) exhibited the highest familiarity with the Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (91.3%), followed by the National Guidelines for the Prevention and Control of Diabetes in Primary Care (76.8%), the Standards of Medical Care in Diabetes (72.2%) and the Guidelines for Prevention and Treatment of Diabetes in Chinese Medicine (63.8%). Primary care practitioners (PCPs) exhibited familiarity with these four guidelines at about 50% or less. Self-reported reference to modern diabetes guidelines by physicians is more frequent than traditional Chinese medicine (TCM) diabetes guidelines, with rates at 73.2% and 33.8%, respectively. Approximately 90% of physicians provided instructions on self-monitoring of blood glucose to their patients with diabetes. Less than one-third of physicians referred patients to a specialised nutritionist. In terms of health education management, TCPs reported having a diabetes health management team at the rate of 75.7%, followed by secondary care hospital physicians at 57.0% and PCPs at 27.5%. Furthermore, approximately 40% of physicians did not fully grasp hypoglycaemia characteristics.

Conclusions

Familiarity and awareness of the screening guidelines varied among physicians in different hospital settings. Importantly, significant discrepancies were observed between physicians’ awareness and their self-reported reference to modern medicine guidelines and TCM guidelines. It is essential to consistently provide education and training on diabetes management for all physicians, particularly PCPs.

Evaluation of functional vision and eye-related quality of life in children with congenital ectopia lentis: a prospective cross-sectional study

Por: Liang · X. · Zheng · D. · Young · C. A. · Ma · Y. · Ling · L. · Zou · M. · Liu · S. · Zhang · X. · Jin · G.
Objectives

This study aims to evaluate the effect of congenital ectopia lentis (CEL) on functional vision and eye-related quality of life (ER-QOL) in children and their families using the Paediatric Eye Questionnaire (PedEyeQ).

Design

A questionnaire survey administered via in-person interviews of patients with CEL and their parents.

Participants

51 children with CEL and 53 visually normal controls accompanied by 1 parent completed the survey questionnaires for the study from March 2022 to September 2022.

Outcome measures

PedEyeQ domain scores. Functional vision and ER-QOL of children and their families were evaluated by calculating and comparing the Rasch domain scores of the PedEyeQ.

Results

PedEyeQ domain scores were significantly worse with CEL compared with controls (p

Conclusions

In this study, children with CEL had reduced functional vision and ER-QOL compared with controls. Parents of children with CEL also experience reduced quality of life.

Explore the use of complementary and alternative medicine among Chinese gynaecological patients with cancer undergoing chemotherapy: a qualitative phenomenological study

Por: Zhang · J. · Luo · B. · Liu · X. · He · Y. · Zuo · Y.
Objectives

To explore the use of complementary and alternative medicine (CAM) by Chinese gynaecological oncology patients undergoing chemotherapy and discuss measures to address the existing gaps.

Design

Qualitative phenomenology. Semistructured in-depth interview. Colaizzi’s method data analysis.

Setting

A tertiary general hospital.

Participants

16 gynaecological oncology patients (mean age 51.7) having undergone ≥1 chemotherapy cycle were recruited by purposive sampling.

Results

Six themes were generated. The participants were under-informed about CAM concept and options. They were open to explore various modalities after chemotherapy as long as it could alleviate symptoms. The gynaecological patients with cancer sought information about CAM from diverse sources, with professional expertise being the most desirable way to seek information. They used CAM as a strategy to support continued chemotherapy and for symptom alleviation. Financial burden was not stressed but they had concerns about sustainability of some therapies. Their attitudes toward different CAM types varied. Some were sceptical about the efficacy.

Conclusions

The Chinese gynaecological oncology patients may be under-informed about CAM. They are open to use various CAM therapies for symptom relief and as a support strategy. However, their attitudes toward specific therapies may vary. Some may host scepticism about certain CAM modalities. The patients actively seek information on CAM and treatment resources but prefer professional expertise to other sources. Financial burden due to continued CAM use is inconclusive due to possible sampling bias. Sustainability of CAM therapies is a common concern because of limited resources and access. Education on CAM should be incorporated into the curriculum of healthcare professionals. Oncologists and nurses should educate gynaecological patients with cancer on the concept and options of CAM, preferably with information tailored to patient’s individual needs. Health authorities should advocate provisions of diverse CAM services and develop the necessary technologies such as network of local care resources.

Epidemiology, site-specific characteristics and survival of carcinosarcoma: a retrospective study based on SEER database

Por: Tang · L.-S. · Zhou · Y.-W. · Wang · J.-L. · Zhang · G.-X. · Xu · C.-H. · Liu · J.-Y. · Qiu · M.
Objectives

Carcinosarcoma (CS) is a rare and biphasic malignancy characterised by a highly invasive biological nature and poor prognosis. This study explored the epidemiology, site-specific characteristics and survival outcome of CS.

Design

We conducted a retrospective study in the Surveillance, Epidemiology and End Results (SEER) database (1975–2018) for primary CS.

Setting and participants

SEER database includes publicly available information from regional and state cancer registries in the US centres. A total of 5042 CS patients were identified. We selected the top five anatomic CS (uterus, double adnexa, lung, bladder and breast) patients for further analysis.

Primary outcome measures

Incidence was estimated by geographical region, age, sex, race, stage and primary site. Trends were calculated using joinpoint regression. The cancer-specific survival (CSS) rate and initial treatment were summarised.

Results

Nearly 80% of CS occurred in the uterus and double adnexa, followed by lung, bladder and breast. The elderly and black population presented the highest age-adjusted rate of CS. The rates of distant metastasis in CS progressively increased from 1989 to 2018. Atlanta was the area with the highest incidence at 0.7 per 100 000. Pulmonary and bladder CS more frequently occurred in men and were diagnosed with regional stage. Distant metastasis was mostly found in ovary/fallopian tube CS. Radiotherapy was more commonly applied in uterine CS, while adnexa CS cases were more likely to receive chemotherapy. Multiple treatments were more used in breast CS. Pulmonary CS seemed to suffer worse CSS (median: 9.92 months), for which radiotherapy might not provide survival benefits (HR 0.60, 95% CI 0.42 to 0.86). Compared with the common histological types in each site, CS had the shortest survival.

Conclusions

CS has unique clinical features in each primary site. Substantial prognosis variances exist based on tumour locations. The aggressive course is the common feature in CS at all sites.

Using functional near-infrared spectroscopy to study effects of virtual reality intervention for adolescents with depression in a clinical setting in China: study protocol for a prospective, randomised, controlled trial

Por: Yu · K. · Wang · L. · Lv · S. · Ye · X. · Liu · L. · Zheng · X. · Jin · R. · Zhou · D. · Zhang · Y. · Min · G. · Wu · S.
Introduction

Adolescent depression has been shown to be associated with many devastating psychosocial outcomes. However, there are many barriers that may prevent depressed individuals from receiving specialised treatment. Virtual reality (VR) technology has shown promise as one avenue for overcoming these challenges. This study first aims to evaluate the effectiveness of VR intervention on adolescent depression symptoms, and second, to determine the intervention’s underlying mechanism of effect using functional near-infrared spectroscopy (fNIRS).

Methods and analysis

This is a single-centre, prospective, randomised controlled clinical trial. Sixty-six eligible adolescents aged 12–18 years with a diagnosis of depression will be randomised in a 1:1 ratio to either the VR treatment group or the conventional treatment group. All patients for both groups will receive usual treatment during a 4-week intervention period. In addition, patients randomised to VR treatment group (n=33) will complete three 20 min VR sessions including attention, executive function and relaxation training per week. Moreover, 33 healthy adolescents will be recruited as the general population. Primary outcome (ie, depressive symptoms) and secondary outcomes (ie, anxiety symptoms, executive function, treatment emergent symptoms, haemoglobin changes measured by fNIRS) will be collected at preintervention, immediately postintervention and at 4 weeks follow-up. The data assessor and analyst will be blinded to group membership.

Ethics and dissemination

Ethical approval has been obtained from the Ethics Committee of Lishui Second People’s Hospital. Written informed consent will be obtained for all participants. Results will be disseminated through peer-reviewed journals, national or international conference presentations, media outlets, the internet and various community activities.

Trial registration number

ChiCTR2300067747.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.-
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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